https://biospectrumindia.com/rssfeed/news/policy%20%26%20regulatory policy & regulatory https://biospectrumindia.com/news/22/28653/cpi-and-bric-sign-letter-of-intent-to-strengthen-uk-india-biomanufacturing-collaboration.html https://biospectrumindia.com/news/22/28653/cpi-and-bric-sign-letter-of-intent-to-strengthen-uk-india-biomanufacturing-collaboration.html Thu, 15 Oct 2026 13:19:01 +0530 CPI and India's Biotechnology Research and Innovation Council (BRIC) have signed a Letter of Intent (LoI) to establish a strategic UK-India Biomanufacturing Partnership. The partnership will strengthen collaboration between two nations with ambitious plans to accelerate biotechnology innovation, scale-up and commercialisation. It's the latest step in a campaign to deepen UK-India collaboration in critical and emerging technologies, supporting ambitions set out under the UK-India Technology Security Initiative (TSI). The development follows a CPI-led UK delegation of 20 high-potential biomanufacturing and pharmaceutical SMEs to India in early 2026 which positioned the UK as a partner of choice for global collaboration. The agreement establishes the foundation for a long-term strategic relationship between CPI and BRIC, supported through joint governance arrangements and the exploration of co-invested programmes and projects in priority areas of shared interest.    The collaboration will focus on identifying and accelerating high-potential innovations across biotherapeutics including vaccines and industrial biotechnology. It will also explore opportunities to strengthen scale-up pathways, support commercialisation, build skills and talent, facilitate knowledge exchange, and encourage collaboration between research organisations, industry, start-ups and SMEs in both countries.   ]]> https://biospectrumindia.com/news/22/28628/govt-expands-control-over-prices-of-cancer-drugs-with-patients-expected-to-save-rs-2500-cr-annually.html https://biospectrumindia.com/news/22/28628/govt-expands-control-over-prices-of-cancer-drugs-with-patients-expected-to-save-rs-2500-cr-annually.html Sun, 11 Oct 2026 14:29:19 +0530 The government has approved capping of margin on supply and sale of non-scheduled anti-cancer drugs. This margin will be limited to 30% of the maximum retail price (MRP). This measure is expected to bring down drug prices by up to 70% and help cancer patients save Rs 2,500 crore annually, which will significantly reduce the amount they have to pay out of pocket. Stringent rules of maximum prices fixed by the government are already in place on essential cancer drugs included in the scheduled list. Under the new decision, price protection has also been increased for those cancer drugs (which are 'non-scheduled' or 'out of the list'); For this, the margin that can be added to patients before they reach them has been limited. An expert committee under the Directorate General of Health Services (DGHS) will finalise the list of drugs to be covered. After this, the National Pharmaceutical Pricing Authority (NPPA) will take a decision and issue a notification. NPPA's analysis of market data showed that non-scheduled anti-cancer drugs increase by about 170% on average, which in some cases can be as high as 700% or even more. To put it simply, the price of a drug increases rapidly as it passes through the supply chain before it reaches the patient. Prices also vary significantly depending on where the medicine is being purchased from a retail pharmacy, hospital pharmacy or online pharmacy. To ensure that these life-saving drugs remain available, manufacturers of non-scheduled anti-cancer drugs will need to maintain their current production levels. The initiative will cover anti-cancer non-scheduled drugs. These include branded and generic, domestically manufactured and imported, patented and unpatented drugs. This will give patients a lot of benefit from low prices and at the same time they will continue to get the necessary medicines. ]]> https://biospectrumindia.com/news/22/28620/governor-gianforte-karnataka-minister-of-information-technology-discuss-partnerships-in-bioscience.html https://biospectrumindia.com/news/22/28620/governor-gianforte-karnataka-minister-of-information-technology-discuss-partnerships-in-bioscience.html Thu, 08 Oct 2026 19:17:28 +0530 Montana Governor Greg Gianforte met with Karnataka Minister for Home, Information Technology, Biotechnology and E-Governance Priyank Kharge on October 7 to discuss opportunities for collaboration in emerging technology, research, and bioscience. “It was great to join Minister Kharge for a productive meeting on the many parallels between India and Montana and begin discussions on future areas of collaboration in quantum, photonics, aerospace, precision agriculture, and bioscience,” Gov. Gianforte said. “As Montana’s economy expands from its roots in agriculture to embrace investments in emerging technologies, we stand strong on the global stage to compete for historic partnerships that will lead to more opportunities for Montanans.” During the meeting, Gov. Gianforte and Minister Kharge discussed opportunities to connect Montana and Karnataka businesses, researchers, universities, and startups in quantum and photonics, precision agriculture, bioscience and pharmaceuticals, semiconductors, and aerospace.  The governor also highlighted Montana’s use of artificial intelligence across state government to improve customer service and make agencies more efficient. With Minister Kharge overseeing information technology and e-governance in Karnataka, the leaders discussed sharing best practices as both governments incorporate new technologies into public services. Building on Montana’s more than 40 years of experience in optics and photonics, the governor highlighted the state’s growing quantum ecosystem and opportunities for research and commercial collaboration. Montana is home to one of the largest optics and photonics clusters in the United States with over 80 companies specializing in the industry. In addition, the federally designated Headwaters Tech Hub has received approximately $41 million to strengthen Montana’s photonics industry and move new technologies from research to commercialization. At Montana State University, QCORE provides researchers and private industry access to quantum computing and test infrastructure. The programme has also received a $31.5 million Air Force Research Laboratory contract to expand quantum research and test-bed capabilities. In the discussion, the governor pointed to Aurora Innovation as one example of Montana’s photonics expertise in action. The company operates a 78,000-square-foot facility in Bozeman where it develops lidar technology used for autonomous vehicles. Karnataka leaders highlighted their work in quantum education, research, computing, and hardware, while the governor discussed opportunities to connect those efforts with Montana State University, researchers, and private-sector companies.  Bioscience was another focus of the meeting. Gov. Gianforte highlighted Montana’s more than $250 million in annual university research funding and the state’s expanded Right to Try law, which creates new opportunities for clinical research and access to qualifying experimental treatments. The leaders discussed opportunities to connect Montana’s research institutions, clinics, and bioscience companies with Karnataka’s biotechnology and pharmaceutical industries and medical education infrastructure.  “Karnataka has the technology ecosystem, talent, research capabilities and entrepreneurial strength to build meaningful partnerships with global innovation hubs. Montana brings highly specialized capabilities in areas such as quantum, photonics, precision agriculture and biosciences,” Minister Kharge said. “The opportunity is to connect these strengths and move from conversations to specific collaborations between institutions, companies, startups and researchers.”  The meeting also included discussions on precision agriculture, semiconductors and chip design, aerospace and space technologies, autonomous systems, and remote sensing.  ]]> https://biospectrumindia.com/news/22/28603/india-strengthens-scientific-partnership-with-switzerland.html https://biospectrumindia.com/news/22/28603/india-strengthens-scientific-partnership-with-switzerland.html Tue, 06 Oct 2026 20:47:03 +0530 Union Minister of State (Independent Charge) for Science & Technology, Dr Jitendra Singh said that the India-Swiss Research Framework (ISRF) will give new impetus to the long-standing India-Switzerland science, technology and innovation partnership and provide a structured platform to take bilateral cooperation into new and emerging areas. Addressing the inaugural India-Swiss Research Flagship Event 2026 in New Delhi, Dr Jitendra Singh said that the event is an occasion not only to celebrate two decades of healthy and growing cooperation, but also to chart the way forward by diversifying the partnership in emerging areas of science, technology and innovation and creating more opportunities for researchers and innovators in both countries. As part of this forward-looking agenda, Dr Jitendra Singh welcomed new initiatives including "Explore," which aims to build new research networks with a view to developing larger consortia, and the Academia-Industry Training (AIT) programme for science-based innovators. The programme presentation also showcased the upcoming Explore programme, scheduled to open in November 2026 as a co-funded SNSF-DST initiative, with a duration of 9-12 months and support for travel, networking, and small equipment to help develop new ideas in basic science into larger research opportunities. Dr Singh also welcomed the Letter of Intent between DST and Swiss National Science Foundation (SNSF) and the Implementation Arrangement between DST and Zurich University of Applied Sciences (ZHAW). The LoI will support exploratory scientific collaboration, future joint research, and long-term collaboration in mutually agreed priority areas, while the Implementation Arrangement will advance collaboration in innovation, technology transfer, and entrepreneurship through the Indo-Swiss Academia-Industry Training (AIT India) programme. ]]> https://biospectrumindia.com/news/22/28605/bts-2026-to-offer-global-platform-for-technology-innovation-and-international-collaboration-dr-manjula.html https://biospectrumindia.com/news/22/28605/bts-2026-to-offer-global-platform-for-technology-innovation-and-international-collaboration-dr-manjula.html Tue, 06 Oct 2026 21:09:28 +0530 The Bengaluru Tech Summit (BTS) 2026 is set to expand its international footprint, offering participating countries a platform to showcase cutting-edge technologies, government initiatives, industry capabilities and academic strengths to a global audience, said Dr Manjula N, Secretary to Government, Department of Electronics, IT, Biotechnology and S&T, Government of Karnataka, at the Global Innovation Alliance (GIA) Meet held in Bengaluru on October 6. Dr Manjula provided an overview of BTS 2026 and highlighted the opportunities available to international partners through the Summit’s international exhibition, conference and country delegations. She also outlined the various outreach activities being undertaken to strengthen international participation at the Summit. Scheduled from November 17 to 19, 2026, at the Bangalore International Exhibition Centre (BIEC), BTS 2026 will be held under the theme ‘AI & Beyond’ and is expected to bring together more than 90,000 attendees, including over 1,000 technology startups, 1,000 investors, 25,000 delegates, 700 speakers and 1,800 exhibitors, with participation from more than 75 countries. The Summit is positioned as a platform for international technology ecosystems to engage with India’s rapidly expanding innovation landscape, while enabling companies, startups, investors, researchers and policymakers to explore partnerships and market opportunities. The BTS 2026 conference will feature 16 tracks covering key technology and innovation domains, including IT & DeepTech, Electro-Semicon, Digital Health & Biotech, Startup Ecosystem, Data & Cybersecurity and Global Collaboration. The Summit will also introduce new tracks such as AI Universe, Finverse, Frontier Tech and Orange Economy, reflecting the expanding application of technology across financial services, frontier technologies and creative and cultural industries. The Global Stage will feature country sessions involving more than 16 nations, providing international delegations with an opportunity to present their technology capabilities and discuss areas of collaboration. A key highlight of BTS 2026 will be the co-location of embedded world India, the maiden India edition of the global event organised by NuernbergMesse India. The event will focus on electronics, semiconductors and embedded systems, adding another major technology dimension to the Summit. The Robotics & Autonomous Systems Arena, led by Bharat 1.AI, will bring robotics companies and researchers together for live demonstrations spanning industrial automation, logistics and medical robotics. The multi-pavilion exhibition will showcase innovations across sectors, with increased international participation and industry representation. BTS 2026 will also place significant emphasis on startups and their access to capital, mentorship and international markets. The programme will include Investor Pitching, one-to-one Mentoring sessions, a dedicated Startup Pavilion and Investor Connect, along with thematic sessions addressing scaling, fundraising and international market access. The Future Makers Conclave, expected to attract more than 10,000 startup founders, will bring together entrepreneurs and changemakers from diverse fields. The Summit will also feature the Rural IT Quiz, Bio Quiz, Bio Posters, IT, Bio and Exhibitor Awards and Global Leaders Reception. With its expanded exhibition, international participation and technology-focused conference programme, BTS 2026 is expected to provide a broad platform for global technology ecosystems to connect with Karnataka and India’s startup, research, investment and industry communities. ]]> https://biospectrumindia.com/news/22/28606/karnataka-hosts-global-innovation-alliance-meet-ahead-of-bengaluru-tech-summit-2026.html https://biospectrumindia.com/news/22/28606/karnataka-hosts-global-innovation-alliance-meet-ahead-of-bengaluru-tech-summit-2026.html Tue, 06 Oct 2026 21:12:45 +0530 The Government of Karnataka hosted the Global Innovation Alliance (GIA) Meet in Bengaluru on October 6, to strengthen international participation and collaboration ahead of the Bengaluru Tech Summit (BTS) 2026, scheduled for November 17–19 at BIEC. Dr Manjula N, Secretary to Government, Department of Electronics, IT, Biotechnology and S&T, provided an overview of BTS 2026 and highlighted opportunities for international partners to showcase their technologies, government initiatives, industry capabilities and academic strengths through the Summit’s exhibition, conference and country delegations. The meet was attended by Priyank Kharge, Minister for Home, IT & Bt and e-Governance, Government of Karnataka; Dr Avinash Menon Rajendran, Managing Director, KITS & KEONICS and Director, Department of E, IT, Bt and S&T, Government of Karnataka; Dr E V Ramana Reddy, (Retd.), Chairman, Karnataka Skill Development Authority; and Jagdish Patankar, Event Curator, BTS 2026 and Executive Chairman, MM Activ Sci-Tech Communications. Representatives from GIA partner countries and international agencies, including Japan, the US, Germany, France, South Korea, Australia, Sweden, Italy, Switzerland, Canada and the Netherlands, among others, also participated in the meet. BTS 2026, themed ‘AI & Beyond’, is expected to bring together more than 90,000 attendees, 1,000 startups, 1,000 investors, 700 speakers and 1,800 exhibitors from over 75 countries. ]]> https://biospectrumindia.com/news/22/28607/karnataka-unveils-new-global-innovation-framework-ahead-of-bengaluru-tech-summit-2026.html https://biospectrumindia.com/news/22/28607/karnataka-unveils-new-global-innovation-framework-ahead-of-bengaluru-tech-summit-2026.html Tue, 06 Oct 2026 21:17:09 +0530 Karnataka is repositioning its global innovation engagement from event-led interactions to sustained partnerships, with the State preparing to roll out a new engagement framework and a dedicated physical platform for international innovation collaborations, Priyank Kharge, Minister for Home, IT & Bt and e-Governance, Government of Karnataka, said on October 6, 2026 in Bengaluru. Speaking at the Global Innovation Alliance (GIA) Meet, organised by the Department of Electronics, IT, Biotechnology and S&T ahead of the Bengaluru Tech Summit (BTS) 2026, Kharge highlighted the need to convert Karnataka’s international partnerships into tangible opportunities for startups, companies, institutions and investors. The GIA Meet brought together representatives from partner countries and international trade missions, including Sweden, Italy, Australia, Poland, Switzerland, Austria, the Netherlands, the US, Vietnam, Denmark, Belgium, Luxembourg, Israel, France, South Korea, Spain, Japan, Canada, Germany, Tunisia, Czech Republic and New Zealand. The Government of Karnataka is now strengthening the GIA framework to make international engagement more structured, reciprocal and outcome-oriented. The proposed framework will focus on four areas: global startup mobility and market access; international institutional partnerships; global visibility and strategic engagement; and governance through a dedicated International Desk. A key component of the next phase is GIGA – Global Innovation and Growth Alliance, a proposed permanent physical infrastructure in Bengaluru that will provide international startups, innovation agencies, delegations and institutions with workspace, meeting and programme facilities. It is intended to connect international partners with Karnataka’s Centres of Excellence, incubators, universities, industry and investors. The initiative signals a shift towards creating a more permanent landing platform for international companies and innovation organisations seeking to establish partnerships and explore opportunities in Karnataka. The GIA network, launched in 2017 under the Karnataka Unit for International Co-operation, has grown from 10 partner countries in 2018 to more than 40 countries in 2026. ]]> https://biospectrumindia.com/news/22/28583/govt-sanctions-rs-1600-cr-for-41-pharma-and-medtech-innovation-projects-under-first-round-of-prip.html https://biospectrumindia.com/news/22/28583/govt-sanctions-rs-1600-cr-for-41-pharma-and-medtech-innovation-projects-under-first-round-of-prip.html Wed, 30 Sep 2026 23:25:30 +0530 Under the first phase of Promotion of Research and Innovation in Pharma MedTech Sector (PRIP), 41 projects with financial assistance of about Rs 1,600 crore have been approved. These sanctioned projects are expected to bring in additional private investment of Rs 3,020 crore, taking the total R&D investment in these projects to about Rs 4,620 crore. The approved portfolio encompasses the innovation value chain, which includes new drug discovery, clinical development, and innovative medical technologies. Out of the 41 projects sanctioned so far, 12 are in the initial stage and 29 are in the later stage. 19 projects are being done by startups and MSMEs, while 22 projects are being done by big companies. As per the priority areas, 27 projects are under New Drugs, five projects are under Complex Generics and Biosimilars and nine projects are under New Medical Devices. These projects primarily reflect the shift from the volume-based pharmaceutical model to the innovation-based, technology-intensive model, bringing together pharmaceutical companies, biotechnology enterprises, and MedTech innovators. The portfolio includes projects from companies and innovators such as Biocon, Bharat Biotech, Sun Pharma, Wockhardt, Zydus, Mankind Pharma, Pandorum Technologies, Celogen Therapeutics, Origin Oncology and Bugworks Research. These projects showcase a wide range of innovation supported under PRIP, including first-class innovations, emerging technologies, innovations with potential for global markets, and strategic priority innovations involving areas critical to public health. The projects supported under these categories include antibacterial drugs targeting multidrug-resistant Gram-negative infections, exosome-based regenerative therapy for corneal disease, in-vivo CAR-T platform, patient-derived breast cancer organoids, programmable RNA-targeting antiviral technology, portable plasmonic-PCR for point-of-care infection diagnosis, and microfluidic platform for TB detection. Under the strategic prioritization framework, more support is available for innovations focusing on areas such as unaddressed tropical diseases, rare diseases, AMR (antimicrobial resistance) for India's priority pathogens (pathogens), pathogens with epidemic or mass transmission potential, and vaccines for vaccine-preventable diseases. So far, six projects have been approved under this framework, which include projects related to bacterial pneumonia/meningitis, dengue, influenza and next-generation TB vaccines. The remaining applications under the first round are under evaluation and the results will be announced in the coming months. ]]> https://biospectrumindia.com/news/22/28561/dbt-is-supporting-210-rd-projects-worth-rs-174-cr-in-nanomedicine-dr-jitendra-singh.html https://biospectrumindia.com/news/22/28561/dbt-is-supporting-210-rd-projects-worth-rs-174-cr-in-nanomedicine-dr-jitendra-singh.html Mon, 28 Sep 2026 16:50:05 +0530 Addressing the inaugural ceremony of the World Congress on Nanomedicine 2026 at Vigyan Bhawan in New Delhi, Dr Jitendra Singh, Minister of State (Independent Charge) for Science & Technology, said that nanomedicine will drive the next generation of preventive medicine and personalised healthcare. The World Congress on Nanomedicine 2026, being held from Sept 27 to 30, organised by the Institute of Nano Medical Sciences, Faculty of Medical Sciences, University of Delhi, attracted over 2,000 participants. These include eminent scientists and young researchers who are discussing emerging advances and applications in the field of nanomedicine. Detailing the government's support for nanomedicine research, Dr Jitendra Singh said that the Department of Biotechnology (DBT) is providing financial assistance of Rs 174 crore to 210 research and development (R&D) projects in the field of nanomedicine. These projects include targeted drug delivery, cancer nanomedicine, nanomedicine for infectious diseases, nucleic acid and vaccine delivery, nanodiagnostics and imaging, regenerative medicine and wound healing, as well as nanotoxicology and regulatory science. Among promising research areas, the Minister mentioned precision nano-injections and targeted breast cancer nanomedicines, in addition to oral insulin nanoparticles and nanobots for breast cancer. He recalled that earlier attempts at oral insulin had encountered challenges related to absorption and digestive enzymes. He said that advances in nanotechnology could offer new possibilities to address these challenges. He said that India has established a regulatory framework for nanopharmaceuticals through guidelines jointly developed by the DBT, ICMR, and CDSCO. This framework provides the basis for evaluating the safety , quality, and efficacy of nanopharmaceutical products. ]]> https://biospectrumindia.com/news/22/28528/govt-unveils-primus-partners-report-outlining-roadmap-to-build-213-b-ayush-economy-by-2030.html https://biospectrumindia.com/news/22/28528/govt-unveils-primus-partners-report-outlining-roadmap-to-build-213-b-ayush-economy-by-2030.html Wed, 23 Sep 2026 17:03:55 +0530 At the 11th Ayurveda Day celebrations organised by the Ministry of Ayush and coordinated by the Central Council for Research in Ayurvedic Sciences (CCRAS), Minister of State, Ministry of Ayush Prataprao Ganpatrao Jadhav unveiled the Primus Partners’ thought leadership report, Ayush Vision 2030: From Traditional Wisdom to Global Leadership. Released under this year’s Ayurveda Day theme, “Ayurveda for a Healthier Tomorrow”, and the tagline “One Health, One Future: Integrating Ayurveda Science through Evidence, Innovation, and Holistic Care,” the report presents a comprehensive roadmap to position Ayush as a major pillar of India’s healthcare and economic transformation over the next decade. The launch was attended by senior dignitaries including Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush, Dr A Raghu, Advisor, Ministry of Ayush. The report states that India’s Ayush ecosystem has reached a defining moment as global healthcare increasingly shifts towards preventive, personalised and holistic care. Ayush Vision 2030 lays out two national ambitions: building a $213 billion Ayush economy by 2030 and establishing Ayush as the first choice for healthcare and well-being, while complementing modern medicine in acute and emergency care. The pathway to these ambitions rests on seven strategic pillars spanning Manufacturing Expansion, Export Promotion, Healthcare Integration, Wellness Tourism, Research & Innovation, Digital Ayush, and Medicinal Plant & Global Ayush Diplomacy.  This will require coordinated action across the Ministry of Ayush, state governments, industry, academia, healthcare providers, research institutions and international partners. The report calls for stronger public-private partnerships, inter-ministerial co-ordination, evidence-based policy frameworks, regulatory harmonisation, greater investment in research and innovation, and globally trusted quality and certification standards for Ayush products and services. ]]> https://biospectrumindia.com/news/22/28530/health-minister-of-goa-launches-indias-first-dedicated-life-course-immunisation-policy-20262036.html https://biospectrumindia.com/news/22/28530/health-minister-of-goa-launches-indias-first-dedicated-life-course-immunisation-policy-20262036.html Wed, 23 Sep 2026 17:17:37 +0530 With an aim to strengthen protection against vaccine-preventable diseases across adulthood, the Government of Goa has launched India’s first dedicated Life-course Immunisation Policy 2026–2036. Titled “Goa Policy for Life-course Immunisation 2026–2036”, the policy and its operational guidelines were developed by the Directorate of Health Services, Goa, in collaboration with Goa Institute of Management (GIM) and Goa Medical College, drawing on consultations with experts at the state and national levels. Vishwajit Pratapsingh Rane, Minister for Health, Government of Goa, formally released the policy, making Goa the first state in the country to adopt a dedicated policy focused on life-course immunisation. The ten-year state policy is designed to extend the benefits of vaccination beyond childhood and integrate adult vaccination into routine healthcare. Speaking at the launch, Vishwajit Pratapsingh Rane emphasised the importance of extending immunisation beyond childhood. He said, “The Goa Policy for Life-course Immunization 2026–2036 reflects our commitment to strengthening preventive healthcare, promoting healthy ageing and protecting adults who are particularly vulnerable to vaccine-preventable diseases. I believe this forward-looking approach presents an opportunity for Goa to demonstrate leadership in prevention-oriented healthcare and contribute valuable experience to the country.” The policy addresses vulnerabilities of adults living with Non-Communicable Diseases (NCDs). Conditions such as heart disease, diabetes, chronic respiratory disease, kidney disease and cancer account for a substantial share of Goa’s disease burden, while individuals living with these conditions can face an increased risk of severe illness from vaccine-preventable infections. The first phase of implementation will focus on pneumococcal, influenza and hepatitis B vaccination for eligible adults. Beneficiaries will include people living with diabetes and chronic heart, lung, kidney or liver diseases, cancer, immunocompromised individuals, as well as healthcare and other frontline workers, in accordance with the policy's eligibility criteria. For this, specialist and NCD clinics at Goa Medical College and district hospitals will identify eligible patients and facilitate vaccination. The policy implementation framework will include centralised vaccine procurement and cold-chain capacity, digital tracking of vaccination coverage, and monitoring of adverse events following immunisation.     ]]> https://biospectrumindia.com/news/22/28515/health-ministry-strengthens-safety-monitoring-of-medicines-medical-devices-and-transplant-procedures.html https://biospectrumindia.com/news/22/28515/health-ministry-strengthens-safety-monitoring-of-medicines-medical-devices-and-transplant-procedures.html Mon, 21 Sep 2026 19:21:55 +0530 Minister of State for Health & Family Welfare and Chemicals & Fertilizers, Anupriya Patel has launched the 7th National Formulary 2026, a guidance document for hospitals in India for safety monitoring and reporting of adverse events related to medical devices, and the ADR-PVPI 2.0 mobile app for iOS users, a secure and popular mobile operating system, at the 6th National Drug Monitoring Week event organised by the Indian Pharmacopoeia Commission (IPC). Adverse events due to medicines can be reported online through the official mobile app developed under the Indian Pharmacovigilance Programme. The 7th edition of the National Formulary is also available digitally through the National Formulary of India Online. The Minister also announced the approval of India's Biovigilance Programme, as part of the expansion of India's patient safety framework. Under this, IPC will play a leading role in strengthening the reporting, evaluation, monitoring and prevention of adverse effects associated with drugs and biological products used in organ and tissue transplantation, including organs and tissues donated to donors and recipients. Pharmacovigilance, materiovigilance and biovigilance initiatives will together strengthen safety monitoring of medicines, medical devices and transplant procedures. Anupriya Patel stated that approximately 1,150 Adverse Drug Reaction (ADR) reporting centres operate in government and private hospitals and medical colleges across the country to report side effects of medications or drugs, as well as medical device monitoring facilities. She added that the government plans to expand these facilities to primary healthcare centres. ]]> https://biospectrumindia.com/news/22/28510/karnataka-approves-marine-biotechnology-policy-2026-2031-to-build-high-value-blue-bioeconomy-.html https://biospectrumindia.com/news/22/28510/karnataka-approves-marine-biotechnology-policy-2026-2031-to-build-high-value-blue-bioeconomy-.html Sun, 20 Sep 2026 16:09:56 +0530 The Government of Karnataka has approved the Karnataka Marine Biotechnology Policy 2026-2031, a five-year framework aimed at unlocking the economic potential of the State’s marine and coastal resources and positioning Karnataka as a leading hub for Marine Biotechnology and the Blue Bioeconomy. With a 343.3-km coastline, established marine science and fisheries institutions, a growing biotechnology ecosystem and a strong base of scientific talent, Karnataka seeks to move beyond traditional coastal activities towards high-value applications in marine biotechnology, biomanufacturing, seaweed-based products, marine biomaterials and sustainable marine enterprises. The policy aims to grow Karnataka’s Blue Bioeconomy from approximately $2 billion to $6–8 billion by 2031, while helping the State secure a larger share of India’s emerging Blue Bioeconomy opportunity. It will focus on translating marine science and research into commercial applications, strengthening coastal innovation infrastructure, creating new enterprise and employment opportunities, and promoting sustainable utilisation of marine resources. The policy has a proposed five-year budget of Rs 120 crore, including investments in KIMBE, Marine Biotechnology Zones, the Seaweed Value Addition PLI, the Karnataka Pilot Blue Carbon Certification Programme. The policy seeks to strengthen the entire value chain from research and bioprospecting to product development, prototyping, commercialisation and investment, enabling greater participation from startups, industry and research institutions. ]]> https://biospectrumindia.com/news/22/28511/karnataka-approves-sustainable-data-centre-policy-2026-2031.html https://biospectrumindia.com/news/22/28511/karnataka-approves-sustainable-data-centre-policy-2026-2031.html Sun, 20 Sep 2026 16:16:26 +0530 The Government of Karnataka has approved the Karnataka Sustainable Data Centre Policy 2026 2031, a five-year policy framework designed to establish the State as a globally competitive, sustainable and well-connected destination for Data Centre investments. The policy seeks to strengthen Karnataka’s digital infrastructure backbone at a time when the rapid growth of Artificial Intelligence, cloud computing, IoT, 5G, Global Capability Centres (GCCs), FinTech and other emerging technologies is driving unprecedented demand for computing capacity. The policy brings together investment facilitation, digital infrastructure, sustainability and ecosystem development, with a focus on attracting domestic and international investments across the Data Centre value chain. It also seeks to expand Data Centre infrastructure beyond Bengaluru, strengthening emerging regional digital corridors and supporting Karnataka’s broader Beyond Bengaluru vision. Rs 1,300.45 crore revised budget framework has been cleared for the implementation of the five-year policy. The policy will be implemented through a phased five-year roadmap, beginning with policy operationalisation, investor facilitation and identification of Data Centre Zones and Parks, followed by ecosystem expansion, R&D, skilling, sustainability-linked incentives and consolidation of Karnataka’s position as a sustainable Data Centre hub. ]]> https://biospectrumindia.com/news/22/28496/health-ministry-proposes-amendment-to-drugs-rules-1945.html https://biospectrumindia.com/news/22/28496/health-ministry-proposes-amendment-to-drugs-rules-1945.html Thu, 17 Sep 2026 16:03:37 +0530 The Ministry of Health and Family Welfare, Government of India has proposed to amend the Drugs Rules, 1945 to strengthen regulatory oversight on Schedule H, H1 and X drugs. The proposal was issued in the draft gazette notification GSR issued on 8th September 2026. Submitted via 791(e). Schedule H, H1, and X drugs are prescription-only medicines in India, with H1 and X subject to stricter controls due to higher risk of misuse or adverse effects. The proposed amendment aims to address concerns related to unauthorised access and sale of Schedule H, H1 and X drugs. It has recommended mandatory CCTV surveillance at medical stores as an additional regulatory safeguard. The proposal was initially considered by the Drug Advisory Committee (DCC). It was then circulated among the members of the Drugs Technical Advisory Board (DTAB) for discussion. After considering the proposal, DTAB recommended its approval. Once implemented, the proposed amendment is expected to strengthen monitoring of sale and distribution of Schedule H, H1 and X drugs and prevent their unauthorised access and sale without a valid prescription. The proposed CCTV surveillance system will also increase transparency and accountability in the drug supply chain, thereby further strengthening public health protection. ]]> https://biospectrumindia.com/news/22/28497/government-issues-advisory-on-regulation-of-stem-cell-therapy.html https://biospectrumindia.com/news/22/28497/government-issues-advisory-on-regulation-of-stem-cell-therapy.html Thu, 17 Sep 2026 16:07:58 +0530 The Ministry of Health and Family Welfare, Government of India, has issued an advisory to all States and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010 regarding the regulation of stem cell therapy. The advisory reiterates the existing regulations on stem cell research and therapy and seeks to ensure that stem cell therapy is allowed as standard care in routine clinical practice only for diseases/conditions on the list approved by the Ministry of Health and Family Welfare. In the advisory, with regard to Autism Spectrum Disorder (ASD), it has been clarified that the therapeutic use of any stem cell in autism is prohibited as per the 'National Guidelines for Stem Cell Research, 2017' issued jointly by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) and other applicable Government instructions issued by the Government of India from time to time. To be restricted to only duly approved clinical trials. The Ministry has requested the States and UTs to give wide publicity to all concerned State and District Regulatory Authorities and government and private clinical establishments involved in stem cell research, treatment, promotion or administration to ensure strict adherence to the applicable regulations. The consultation also draws attention to the consequences of not following the rules associated with stem cell therapy.  Accordingly, the Ministry has requested the concerned State and District Regulatory Authorities and Clinical Establishments to ensure strict compliance of the Regulations on Stem Cell Research and Therapy.   ]]> https://biospectrumindia.com/news/22/28468/govt-unveils-indian-pharmacopoeia-reference-substance-for-enoxaparin-sodium-for-bioassays.html https://biospectrumindia.com/news/22/28468/govt-unveils-indian-pharmacopoeia-reference-substance-for-enoxaparin-sodium-for-bioassays.html Sat, 12 Sep 2026 11:52:56 +0530 The Indian Pharmacopoeia Commission (IPC), an autonomous body under the Ministry of Health and Family Welfare, Government of India, recently organised a two-day national conference on "Quality and Safety of Biosimilars: Strengthening India's Biopharma Shakti (SHAKTI) Vision" at the Centre for Cellular and Molecular Platforms (C-CAMP), Bengaluru. A major highlight of the conference was the release of the Indian Pharmacopoeia Reference Substance (IPR) for Enoxaparin Sodium for Bioassays. Enoxaparin Sodium is a low molecular weight heparin and anticoagulant widely used for the prevention and treatment of thromboembolic disorders. The IPR for Enoxaparin Sodium for Bioassays can serve as a certified reference material for bioassay testing, helping to ensure accurate, consistent, and comparable evaluation of its biological activity. This release of the IPR is a significant step towards strengthening the availability of certified Pharmacopoeia Reference Substances for Bioassays related to Enoxaparin Sodium. It will also contribute to the vision of Atmanirbhar Bharat by strengthening India's indigenous drug quality infrastructure. The conference was organised by the Indian Pharmaceutical Commission (IPC) in collaboration with the Indian Drug Manufacturers Association (IDMA). The Biotechnology Industry Research Assistance Council (BIRAC) and the Centre for Cellular and Molecular Platforms (C-CAMP) served as knowledge partners, while the Karnataka Drugs and Pharmaceuticals Manufacturers Association (KDPMA) was the associate partner.  ]]> https://biospectrumindia.com/news/22/28454/itra-jamnagar-and-heartfulness-institute-sign-mou-to-promote-ayurveda-holistic-healthcare-and-environmental-sustainability.html https://biospectrumindia.com/news/22/28454/itra-jamnagar-and-heartfulness-institute-sign-mou-to-promote-ayurveda-holistic-healthcare-and-environmental-sustainability.html Thu, 10 Sep 2026 15:58:38 +0530 The Institute of Teaching and Research in Ayurveda (ITRA), an Institute of National Importance, Jamnagar, under the Ministry of AYUSH, has signed a five-year Memorandum of Understanding (MoU) with the Heartfulness Institute (HFI), Kanha Shanti Vanam, Hyderabad. This MoU provides a framework to leverage the complementary strengths of ITRA in Ayurveda education, clinical practice, and research, and HFI in meditation, yoga, lifestyle practices, and environmental initiatives. The partnership aims to promote preventive and holistic healthcare through an integrated approach. Key areas of cooperation include national and international collaborative research, student and faculty exchange programs, educational programs, knowledge sharing, capacity building, innovation, and intellectual property development. The partnership will also promote research and academic collaboration in areas related to disease prevention and holistic health. This collaboration is in line with the Ministry of AYUSH's efforts to advance evidence-based research, preventive healthcare, quality education and global promotion of Ayurveda, thereby promoting holistic health and sustainable development. ]]> https://biospectrumindia.com/news/22/28462/maharashtra-plans-establishment-of-5000-acre-chemical-parks-and-rs-1000-cr-innovation-fund.html https://biospectrumindia.com/news/22/28462/maharashtra-plans-establishment-of-5000-acre-chemical-parks-and-rs-1000-cr-innovation-fund.html Thu, 10 Sep 2026 22:15:51 +0530 Maharashtra is set to introduce a dedicated Chemical Sector Policy by the end of October, while exploring the development of 2,500–5,000-acre chemical parks in Palghar, Raigad and Ratnagiri and planning a Rs 1000-crore Maharashtra Industries and Investment Fund to support R&D, technology readiness and innovation, senior state government officials said at MahaChem 2026 in Mumbai. The upcoming policy will further build on Maharashtra’s strong chemical manufacturing base and reinforce its position as a global hub for the sector, opening up new opportunities for investments across specialty chemicals, advanced materials, battery materials, electronic chemicals, advanced polymers, bioplastics and other high-value segments. Dr P. Anbalagan IAS, Principal Secretary Industries, Investment and Services Department, Government of Maharashtra, said at ASSOCHAM MahaChem 2026, the state is taking steps to create a stronger ecosystem for the chemical sector, with a dedicated policy, new chemical parks and measures to support innovation and technology-led growth. Praveen Pardeshi IAS, Chief Economic Advisor to Hon’ble Chief Minister and Chief Executive Officer, Maharashtra Institution for Transformation (MITRA), said at ASSOCHAM MahaChem 2026, the chemical and pharmaceutical sectors would be critical to Maharashtra’s ambition of becoming a $1 trillion economy, with competitiveness increasingly dependent on access to utilities, energy and water, as well as supportive policy reforms. Devendra Fadnavis, Chief Minister, Government of Maharashtra said, “We invite investors to look at Maharashtra for their next big venture. The state is committed to creating a pro-business environment through the single-window MAITRI platform, faster clearances and robust policy incentives. A sector-specific Chemical Sector Policy will soon be announced, which will further help attract investments and accelerate growth.” According to the ASSOCHAM-EY report, ‘Maharashtra: Fuelling India’s Trillion-Dollar Chemical Vision,’ released at MahaChem 2026, Maharashtra’s chemical sector is valued at around $22 billion, with more than 3,600 factories and 13 designated chemical zones. ]]> https://biospectrumindia.com/news/22/28448/cdsco-signals-shift-towards-smarter-risk-based-regulation-to-ease-doing-business-for-indian-pharma.html https://biospectrumindia.com/news/22/28448/cdsco-signals-shift-towards-smarter-risk-based-regulation-to-ease-doing-business-for-indian-pharma.html Wed, 09 Sep 2026 22:14:01 +0530 The Central Drugs Standard Control Organisation (CDSCO) is moving towards a smarter, risk-based regulatory approach that reduces and prioritises intervention, simplifies processes and applies greater proportionality to compliance, while continuing to safeguard the quality, safety and efficacy of medicines, Dr Ranga Chandrashekhar, Joint Drug Controller, CDSCO, Ministry of Health & Family Welfare, Government of India, said during a panel discussion at iPHEX 2026 organised by Pharmexcil. Speaking at a session focused on rationalising criminal provisions governing business and regulatory compliance, Dr Chandrashekhar said CDSCO has examined the drug approval pathway to identify areas where regulatory intervention can be reduced without compromising quality. He pointed to measures where certain requirements have moved from prior approval to prior intimation, including manufacturing for test and analysis before approval, helping reduce processing time. He also said that for BA/BE studies clinical study designs are standardised and adequate guidance is provided enabling prior intimation for generation of data for export purpose. He also highlighted CDSCO’s increasing use of digital systems, dashboards and supervisory mechanisms to reduce processing time and improve oversight. Referring to the Jan Vishwas framework, Dr Chandrashekhar said certain procedural and record-keeping offences have been reviewed to ensure that the regulatory response is proportionate to the nature of the lapse, with compounding the offences with monetary penalties available in appropriate cases while retaining deterrence. Raja Bhanu, Director General, Pharmexcil, said, “For Indian pharmaceutical companies, particularly exporters and MSMEs, regulatory clarity and predictability are critical to competitiveness. A smarter, risk-based approach can reduce avoidable compliance burden while maintaining the standards expected in global markets. This balance between strong regulation, ease & speed of doing business will be important as India strengthens its position as a trusted pharmaceutical partner worldwide.” The discussion reflected a broad convergence that ease of doing business in pharmaceuticals does not mean weaker regulation, but a more risk-based and proportionate framework that simplifies compliance for legitimate businesses while retaining strong safeguards around quality, safety and serious violations.The discussion formed part of iPHEX 2026, the 12th edition of India’s flagship pharmaceutical exhibition, organised by Pharmexcil with the support of the Department of Commerce, Ministry of Commerce and Industry, Government of India, under the Bharat Health Global Expo 2026 at Bharat Mandapam, New Delhi.  ]]> https://biospectrumindia.com/news/22/28436/karnataka-aims-to-build-technology-innovation-bridge-with-australia.html https://biospectrumindia.com/news/22/28436/karnataka-aims-to-build-technology-innovation-bridge-with-australia.html Sat, 05 Sep 2026 13:48:09 +0530 The Government of Karnataka has signed a Memorandum of Understanding (MoU with inQ Innovation Global, Australia, to build a Technology & Innovation Bridge between Karnataka and New South Wales. Minister for Electronics, IT & Biotechnology, Government of Karnataka, Priyank Kharge, was present at the MoU signing. The partnership aims to create structured pathways for Karnataka startups and technology companies to access global markets, investors, industry networks and innovation ecosystems. With a focus on DeepTech and emerging technologies, the collaboration will drive engagement across AI, HealthTech, Biotechnology, CleanTech, Defence & Aerospace, Quantum Computing, Digital Infrastructure, AVGC-XR and Gaming. The MoU will also strengthen connections between startups, investors, research institutions, universities and industry, creating opportunities for market access, startup mobility, research collaboration and global scale-up. This indicates a step towards connecting Karnataka's innovation ecosystem with global opportunities and enabling startups to scale beyond borders. ]]> https://biospectrumindia.com/news/22/28395/prip-scheme-opens-up-new-opportunities-for-startups-msmes-and-industry-in-pharma-and-medtech-sectors.html https://biospectrumindia.com/news/22/28395/prip-scheme-opens-up-new-opportunities-for-startups-msmes-and-industry-in-pharma-and-medtech-sectors.html Fri, 28 Aug 2026 21:43:35 +0530 The Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers, government of India, has announced the second date for inviting applications under the Research and Innovation Promotion in Pharma and MedTech (PRIP) Scheme. With a financial outlay of Rs 5,000 crore, the scheme aims to strengthen the country's pharma and MedTech R&D ecosystem by supporting startups, MSMEs, and large companies to move faster in the innovation value chain. Applications are invited for two categories: Preparatory Phase: Projects of startups and MSMEs with the objective of scaling up products or technologies at TRL (Technology Readiness Level) 1, 2 or 3 in priority areas to a higher TRL not exceeding TRL 5 will be eligible. A two-stage process will be followed for these projects, starting with a brief concept note. This will be followed by a detailed application for the selected applicants. The concept notes can be submitted by eligible MSMEs and startups directly or by ecosystem enablers on behalf of promising projects that exist in their network. Financial assistance up to Rs 5 crore per project will be provided under this scheme. Subsequent Phases: Projects in industry, startups, and MSMEs that aspire to scale up the products or technologies present on TRL 4, 5, or 6 in priority sectors to a higher level are eligible. Projects in further stages can apply directly through a detailed application form. Under the scheme, a maximum financial assistance of Rs. 100 crore per project will be provided, subject to a maximum of 35% of the total project cost sanctioned, and the balance amount will have to be co-financed by the applicant. ]]> https://biospectrumindia.com/news/22/28373/central-bureau-of-narcotics-and-pharmexcil-sign-mou-to-regulate-controlled-substances-in-pharma-exports.html https://biospectrumindia.com/news/22/28373/central-bureau-of-narcotics-and-pharmexcil-sign-mou-to-regulate-controlled-substances-in-pharma-exports.html Tue, 25 Aug 2026 16:24:36 +0530 The Central Bureau of Narcotics (CBN), Department of Revenue, Ministry of Finance, and the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL), set up by the Ministry of Commerce and Industry, have signed a Memorandum of Understanding (MoU) to promote legitimate pharmaceutical exports while preventing the diversion of controlled substances. The documents were exchanged between Dr Dinesh Bisen, Narcotics Commissioner, representing CBN, and Raja Bhanu, Director General, PHARMEXCIL at the CBN Headquarters, Gwalior. Under the MoU, the CBN has developed a Voluntary Code of Conduct in close consultation with PHARMEXCIL, setting out recommended practices for the industry. The code remains voluntary and non-binding and is designed not to interfere with normal business operations or create statutory or financial burdens on exporters beyond applicable laws. Member companies will nominate contact persons to coordinate matters associated with the code. The two sides will also identify operational bottlenecks and recommend measures to streamline export procedures for compliant exporters. Joint workshops, seminars and awareness campaigns will be organised, in coordination with government institutions including the Central Drugs Standard Control Organisation and Customs where required. The MoU further establishes a framework for the exchange of information needed to meet regulatory objectives, subject to applicable laws and confidentiality obligations. Both sides also deliberated on a six-month action plan that will prioritise pan-India outreach, stakeholder sensitisation and establishing core areas of institutional and regulatory cooperation. Speaking on the occasion, K. Raja Bhanu, Director General, PHARMEXCIL, said: "Narcotic drugs and psychotropic substances are essential raw materials for our industry, used in anaesthesia and pain management, but we are equally conscious that diversion, even in small measure, can cause serious harm. Through this MoU, PHARMEXCIL commits to act as a genuine industry interface for CBN disseminating regulatory advisories to our exporter members, mobilising their participation in awareness and training programmes, and building a culture of self-regulation that does not wait for enforcement to arrive at the factory gate." ]]> https://biospectrumindia.com/news/22/28362/health-ministry-proposes-amendments-to-medical-devices-rules-2017-to-promote-ease-of-doing-business.html https://biospectrumindia.com/news/22/28362/health-ministry-proposes-amendments-to-medical-devices-rules-2017-to-promote-ease-of-doing-business.html Mon, 24 Aug 2026 18:59:12 +0530 The government has introduced major regulatory reforms in the medical devices sector with an aim to promote ease of doing business (EoDB), simplify regulatory processes, enhance transparency, and facilitate timely access to advanced medical technologies in the country. Towards this objective, the Medical Devices Regulations, 2017 have recently been amended to simplify the regulatory framework governing outsourced sterilisation of medical devices and to expand the list of stringent regulatory jurisdictions recognised to remove diagnostic requirements. The amendment to Rule 44 of the Medical Devices Regulations, 2017 has been finalised after extensive stakeholder consultations aimed at simplifying regulatory compliances for medical device manufacturers availing outsourced sterilisation facilities. Under the amended provisions, manufacturers outsourcing sterilisation of products to any other facility having a valid license under the Medical Devices Rules, 2017 will no longer be required to obtain a separate loan license for outsourced sterilisation activity. The amendment eliminates the need for a separate loan licensing process in such cases, reducing duplication, administrative burden, compliance costs, and associated timelines, especially for manufacturers who do not have in-house sterilisation facilities. The amended provision also provides for a transition period of six months for implementation of the new labelling requirement. Further, Rule 63 of the Medical Devices Regulations 2017 has been amended to include the European Union (EU) in the stringent regulatory jurisdictions recognised for relaxation of diagnostic testing requirements for medical devices without prescribing devices. ]]> https://biospectrumindia.com/news/22/28359/government-bans-fdcs-containing-chlorpheniramine-maliate-and-phenylephrine-hydrochloride-for-children-below-4.html https://biospectrumindia.com/news/22/28359/government-bans-fdcs-containing-chlorpheniramine-maliate-and-phenylephrine-hydrochloride-for-children-below-4.html Sat, 22 Aug 2026 18:37:40 +0530 In an important step to protect the health and safety of young children, the government has banned the manufacture, sale, and distribution of all fixed dose combinations (FDCs) containing chlorpheniramine maliate and phenylephrine hydrochloride, and mandated that these drugs should not be used in children below the age of four. Earlier, through the Notification [SO 1717(E)] dated 15th April 2025, the government had banned certain Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maliate and Phenylephrine Hydrochloride, imposing age-specific warnings. The latest notification imposes this requirement on all formulations containing these two ingredients. The decision has been taken following the recommendations of the Expert Committee and the Drugs Technical Advisory Board (DTAB). The government said that the use of such a combination could pose a risk to children under the age of four and that safer alternatives are available. Manufacturers have been directed to clearly display on the labels, package inserts and promotional material related to these drugs with a clear warning, "Fixed dose combinations should not be used in children below four years of age." " This notification has been issued in the interest of public health under Section 26A of the Drugs and Cosmetics Act, 1940 and is in force from the date of its publication in the Official Gazette. ]]> https://biospectrumindia.com/news/22/28331/telangana-aims-to-emerge-as-indias-life-sciences-innovation-capital-with-25b-investment-target-by-2030.html https://biospectrumindia.com/news/22/28331/telangana-aims-to-emerge-as-indias-life-sciences-innovation-capital-with-25b-investment-target-by-2030.html Tue, 18 Aug 2026 13:54:11 +0530 As India sets an ambitious roadmap to reach a $130 billion pharmaceutical market valuation by 2030, industry leaders converged in Hyderabad to outline the country’s shift from volume-driven manufacturing to high-value innovation, research, and global regulatory excellence. Ahead of the 19th edition of CPHI & PMEC India 2026, scheduled for November across two venues, senior stakeholders emphasized that the next phase of Indian pharma requires a synchronised effort across CDMO services, digital transformation, and stringent quality compliance. The official launch and precursor event of CPHI & PMEC India 2026, held under the banner of the Pharma Leadership Exchange at the Novotel Hyderabad Convention Centre, brought together an exceptional gathering of pharma leaders, CXOs, industry stalwarts, and key voices from across India’s pharmaceutical and life sciences ecosystem, including Sarvesh Singh, Director & CEO,  LifeSciences & Pharma, Government of Telangana; Pushpa Vijayaraghavan, Director, Healthcare & Lifesciences Advisory, Sathguru Management Consultants; M. Roja Rani, Executive Director, Bulk Drug Manufacturers Association of India (BDMAI) and Chakravarthi AVPS, Chairman-Federation of Pharma Entrepreneurs, Telangana & Andhra Pradesh, and Rahul Deshpande, Sr. Group Director, Informa Markets in India. With Telangana contributing nearly 40% of India’s pharmaceutical production and approximately one-third of global vaccine output, the state is positioning itself as the nation’s life sciences innovation capital. Sarvesh Singh, CEO, Lifesciences & Pharma, Government of Telangana, said, “Our focus is on moving up the value chain, from generics and APIs to biologics, biosimilars, cell and gene therapies, and other cutting-edge areas where biology, chemistry and technology converge. With a strong research ecosystem, global capability centres, a deep talent pool, world-class manufacturing infrastructure and more than 20 dedicated life sciences incubators supporting over 1,000 startups, Telangana has all the ingredients to drive the next phase of life sciences innovation. Through our Next-Gen Life Sciences Policy 2026–2030, we aim to attract $25 billion in investments and create more than 5 lakhs jobs over the next five years. We are also positioning Telangana at the intersection of biology and deep technology, leveraging AI, data science and advanced technologies to accelerate research, innovation and sustainable manufacturing. We are strengthening global partnerships across the US, Europe, Japan, South Korea and China, while creating an environment that enables global companies, research institutions and startups to collaborate and scale. Our Green Skills Centre of Excellence, established in collaboration with Microsoft and 1M1B, is another important step, using AI and deep tech to address real-world sustainability and ESG challenges while building future-ready skills." Industry experts noted that while India maintains a robust generic medicine base, the future lies in "backward integration"—reducing dependency on imported key starting materials—and embracing the CRDMO (Contract Research and Development Manufacturing Organization) boom. With the global CRDMO industry projected to reach up to $22 billion by 2030, integration between technology providers and manufacturers is becoming a strategic necessity. The 19th edition of CPHI & PMEC India 2026 will be hosted across two venues, with CPHI India at IICC, Yashobhoomi, Dwarka from 23–25 November 2026, and PMEC India at IEML, Greater Noida from 24–26 November 2026. CPHI India will focus on finished dosage, excipients, natural extracts, fine chemicals and intermediates, and APIs, while PMEC India will focus on cleanroom technology, machinery and equipment, packaging, and laboratory and analytical equipment. The shows will also be supported by key industry bodies including the Pharmaceuticals Export Promotion Council of India (Pharmexcil), Indian Pharmaceutical Alliance (IPA), Organisation of Pharmaceutical Producers of India (OPPI), Indian Drug Manufacturers’ Association (IDMA) and Federation of Pharma Entrepreneurs (FOPE). ]]> https://biospectrumindia.com/news/22/28322/tamil-nadu-govt-inks-mous-worth-over-rs-67000-cr-at-investors-conclave-2026.html https://biospectrumindia.com/news/22/28322/tamil-nadu-govt-inks-mous-worth-over-rs-67000-cr-at-investors-conclave-2026.html Sat, 15 Aug 2026 22:22:40 +0530 In the presence of Chief Minister of Tamil Nadu, Thiru C. Joseph Vijay, the Vettri Tamil Nadu Investment Conclave was held in Chennai on 13 august, marking a significant milestone in Tamil Nadu’s investment and employment journey. A total of 97 MoUs were signed, attracting Rs 67,452 crore in investments and creating 1,06,998 employment opportunities. Foundation stones were laid for 8 projects worth Rs 4,476 crore, generating 5,074 jobs, while 5 projects involving Rs 2,676 crore investment and 1,550 jobs were inaugurated. Within the life sciences sector, Trivitron Healthcare announced its Rs 200 crore brownfield expansion, creating approximately 200 direct employment opportunities and strengthening capabilities across Molecular Diagnostics, Intensive Care and Dialysis. Caplin Point Laboratories has signed an MoU for an investment of Rs 925 crore towards establishing four new pharmaceutical manufacturing units in Tamil Nadu, including a Biologics & Biosimilars and Hormone injectables unit. Green Signal Bio Pharma has announced an investment of Rs 130 crore, with 120 new job opportunities, focusing on vaccine manufacturing. Genrobotics has marked a new milestone signing an MoU with the Government of Tamil Nadu for a Rs 150 crore investment over the next five years to establish a high-end robotics manufacturing base, create 1,000+ jobs, and position Tamil Nadu as a global manufacturing and export hub for their robotics solutions. CellBios Healthcare & LifeSciences has signed a Memorandum of Understanding (MoU) to establish greenfield manufacturing units for cell & gene therapy based products in Dindigul and Krishnagiri, with an investment of Rs 150 crore, creating 250 new jobs. AcrannoLife Genomics has announced an investment of Rs 210 crore, offering 210 new jobs for the development of molecular diagnostics equipment, genomics and precision medicine KP Manish Global Ingredients has announced an investment of Rs 600 crore, with 400 new jobs opportunities, focusing on the development of API and pharma excipients. ]]> https://biospectrumindia.com/news/22/28286/birac-startup-investor-connect-to-support-biotechnology-opportunities.html https://biospectrumindia.com/news/22/28286/birac-startup-investor-connect-to-support-biotechnology-opportunities.html Mon, 10 Aug 2026 19:39:40 +0530 Union Minister of State (Independent Charge) for Science and Technology Dr Jitendra Singh recently held a meeting with senior officials of Biotechnology Industry Research Assistance Council (BIRAC) in New Delhi, where a series of measures to expand investment, industry participation and market opportunities for India's biotechnology ecosystem were discussed. BIRAC proposes BIRAC Startup Investor Connect, a dedicated platform to bring together investor ready biotech startups and investors. The platform aims to raise awareness of biotechnology opportunities, facilitate strategic partnerships, strengthen investment networks, and accelerate the commercialisation of innovative technologies. Strengthening the reach and visibility of BIRAC was another important area of focus. BIRAC has proposed branding initiatives at Jammu and Vadodara airports to showcase the achievements of DBT-BIRAC and create awareness among corporates, investors and global partners about opportunities to collaborate with India's biotechnology ecosystem. Jammu is emerging as a major hub for biotechnology, healthcare, and agricultural innovation, while Vadodara has an established base of pharma-biotech manufacturing. The meeting also focused on leveraging the growing Life Sciences Global Capability Centre (GCC) ecosystem to increase industry participation in India's biotechnology sector. India currently has over 1,700 GCCs employing around 1.9 million professionals, while the Life Sciences and Healthcare GCC has emerged as important centres of R&D in areas including biopharmaceuticals, medical devices, and digital health. BIRAC will help in better integrating the current and potential GCC with the domestic biotechnology ecosystem by assessing their requirements in infrastructure, pilot-scale manufacturing, and R&D and linking them to India's BioE3 bio-foundries, bio-incubators and startups. BIRAC has set up a dedicated BIRAC-RDIF division to ensure smooth implementation of the Fund. A total of 198 applications have been received and are being evaluated as per the guidelines of the scheme. The first 50 applications have been screened and evaluated, with eight eligible Technology Entities selected so far on the recommendations of the Investment Committee consisting of external experts. These entities are currently undergoing a detailed vetting process before entering into debt or equity agreements. ]]> https://biospectrumindia.com/news/22/28270/health-minister-releases-knowledge-paper-on-ai-in-medtech.html https://biospectrumindia.com/news/22/28270/health-minister-releases-knowledge-paper-on-ai-in-medtech.html Sat, 08 Aug 2026 19:27:24 +0530 Union Minister of Chemicals & Fertilizers and Health & Family Welfare J. P. Nadda released a knowledge paper on "AI in MedTech: Revolutionising Healthcare Through Artificial Intelligence" at the 9th Edition of India Medical Device 2026, organised by the Department of Pharmaceuticals in association with FICCI, at Vigyan Bhawan, New Delhi, on 8 August. The report highlights the growing role of Artificial Intelligence (AI) in the healthcare sector, from creating new opportunities to addressing emerging challenges. Jointly developed by Praxis Global Alliance, in association with FICCI, the knowledge paper examines India's evolving AI-enabled MedTech landscape and outlines the strategic actions needed to accelerate responsible AI adoption across healthcare. It explores AI's role in diagnostics, clinical decision support, operational efficiency and medical device innovation, while identifying the regulatory, policy and ecosystem interventions required to enable large scale adoption. The report while noting that India has already built important foundations through the Ayushman Bharat Digital Mission (ABDM), the IndiaAI Mission, SAHI, BODH and the National Medical Devices Policy, 2023, observes that moving AI solutions from successful pilots to large-scale clinical adoption is a major challenge. The report notes that this transition requires addressing fragmented health data and limited evidence, developing predictable lifecycle-based regulation for adaptive AI, and creating supportive reimbursement and procurement mechanisms. The report highlights five priorities for accelerating AI-enabled MedTech adoption in India: •MedTech represents India's most immediate and scalable AI opportunity, •India has the foundations for AI leadership, but not yet the ecosystem for scale, •India must move beyond successful pilots to routine clinical adoption by addressing three ecosystem gaps: AI-ready data and evidence, lifecycle-based regulation, and procurement and reimbursement mechanisms that recognise AI-enabled value' •AI-enabled diagnostics are expected to be the first large-scale application, •Coordinated action across government, regulators, healthcare providers, payers, industry and academia will be essential to position India as a global leader in responsible AI-enabled MedTech. ]]> https://biospectrumindia.com/news/22/28244/ministry-of-ayush-and-indiaai-sign-mou-on-harnessing-artificial-intelligence-for-future-of-traditional-medicine.html https://biospectrumindia.com/news/22/28244/ministry-of-ayush-and-indiaai-sign-mou-on-harnessing-artificial-intelligence-for-future-of-traditional-medicine.html Sat, 01 Aug 2026 22:13:11 +0530 The Ministry of Ayush and IndiaAI of the Ministry of Electronics and Information Technology have signed a Memorandum of Understanding (MoU) towards promoting Artificial Intelligence (AI) driven innovation in the Ayush sector as a significant step towards leveraging emerging technologies to strengthen the Ayush systems ecosystem. The MoU was signed by Dr Kavita Jain, Joint Secretary and Chief Vigilance Officer, Ministry of Ayush and Sudeep Srivastava, Chief Operating Officer, IndiaAI Mission and Joint Secretary, MeitY in the presence of senior officials from the Ministry of Ayush and IndiaAI.   This collaboration is a significant step towards building a technology-based Ayush systems ecosystem by bringing together traditional knowledge and modern AI capabilities. The partnership will focus on accelerating the adoption and application of AI in key Ayush sectors, including research, capacity building, medicinal plants, and drug administration. Under this collaboration, the Ministry of Ayush will be connected to the AI Kosh platform that will enable sharing of relevant health research content, including datasets, metadata, AI models, toolkits, and relevant use cases. This integration is expected to foster better collaboration, innovation, and responsible development of AI solutions for the Ayush sector. The MoU will be instrumental in providing access to GPU-based and high-performance computing infrastructure at discounted rates through the IndiaAI initiative, subject to defined service-level agreements. Access to advanced computing infrastructure is expected to address critical infrastructure needs and support the expansion of sophisticated AI research and applications in healthcare and traditional medicine. ]]> https://biospectrumindia.com/news/22/28242/cdsco-is-piloting-ai-across-regulatory-processes-to-create-data-driven-regulatory-system-dcgi.html https://biospectrumindia.com/news/22/28242/cdsco-is-piloting-ai-across-regulatory-processes-to-create-data-driven-regulatory-system-dcgi.html Fri, 31 Jul 2026 12:16:17 +0530 The Global Drug Regulatory Conclave (GDRC) 2026, organised by Pharmexcil, focused on strengthening India's pharmaceutical regulatory ecosystem. India is building a future-ready drug regulatory framework to accelerate healthcare innovation while maintaining the highest standards of patient safety, quality, and efficacy, Union Minister for Health and Family Welfare J.P. Nadda said in his virtual address at the inaugural Global Drug Regulatory Conclave (GDRC) 2026, on 30 July in Delhi. Reinforcing this vision, Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi announced at the event that the Central Drugs Standard Control Organisation (CDSCO) will roll out the first phase of an end-to-end digital drug regulatory platform within the next 18 months, marking a significant step in modernising India's pharmaceutical regulatory ecosystem. Highlighting the Government's ongoing regulatory reforms, Nadda said CDSCO is undergoing a comprehensive transformation driven by transparency, scientific rigour, efficiency, accountability, and digital governance. He added that digital regulatory platforms, risk-based oversight, strengthened inspection systems, and enhanced surveillance are creating a modern regulatory ecosystem that inspires greater global confidence. Calling for deeper international collaboration, he urged regulators to strengthen information sharing, regulatory science partnerships, collaborative inspections, and the convergence of scientific standards to improve global access to safe, effective, and affordable medicines. In his opening remarks at the event, Dr Rajeev Singh Raghuvanshi outlined CDSCO's roadmap for regulatory transformation centered on digitalisation, innovation, quality assurance, and global regulatory convergence.  Dr Raghuvanshi said more than 99 percent of CDSCO's regulatory processes have already been digitised, significantly improving transparency and approval timelines. Building on this, CDSCO is piloting Artificial Intelligence (AI) across regulatory processes to create a faster, more agile, and data-driven regulatory system. He also announced that GMP and Certificate of Pharmaceutical Product (COPP) certificates will soon carry QR-code-based digital authentication, enabling overseas regulators to instantly verify their authenticity while reducing verification timelines. Highlighting initiatives to strengthen quality and innovation, Dr Raghuvanshi said CDSCO has streamlined its export regulatory framework through a fully digitised export No Objection Certificate (NOC) system, introduced globally aligned regulatory reliance mechanisms, and accelerated approval pathways to enable faster patient access to innovative therapies. Around 25–30 percent of clinical trials are currently being considered for waiver for eligible innovative products. He further highlighted MedTech Mitra, which has already supported more than 800 startups in navigating regulatory pathways, and noted that similar facilitation mechanisms are planned for biologics and other emerging technologies. Namit Joshi, Chairman, Pharmexcil, said, “India has earned its position as the pharmacy of the world, and the next step is to become a stronger regulatory partner. As global expectations on quality and compliance continue to evolve, GDRC will bring regulators and industry together to promote harmonised standards, clearer regulatory pathways, and faster access to quality, affordable medicines. It will also help translate policy into consistent compliance across the industry, strengthening confidence in Indian pharmaceuticals across global markets.” The Global Drug Regulatory Conclave 2026, organised by the CDSCO in association with Pharmexcil, brought together global drug regulatory authorities, policymakers, researchers, industry leaders, and international organisations to deliberate on the future of pharmaceutical regulation. ]]> https://biospectrumindia.com/news/22/28235/invest-india-and-apacmed-sign-mou-to-strengthen-indias-medtech-ecosystem.html https://biospectrumindia.com/news/22/28235/invest-india-and-apacmed-sign-mou-to-strengthen-indias-medtech-ecosystem.html Thu, 30 Jul 2026 20:42:19 +0530 Invest India, the National Investment Promotion and Facilitation Agency of the Government of India, has signed a Memorandum of Understanding (MoU) with the Asia Pacific Medical Technology Association (APACMED) at Bharat Mandapam in New Delhi. The MoU aims to strengthen cooperation between the government and the global MedTech industry to promote investment, innovation, and sustainable growth in India's Medical Technology Sector (MedTech). The MoU was exchanged in the presence of Manoj Joshi, Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers and Dr M. Srinivas, Member, NITI Aayog. The partnership provides a framework for cooperation in areas such as investment facilitation, regulatory and policy engagement, research and innovation, technology transfer, and digital health. It will foster greater engagement with APACMED member companies and facilitate investment and expansion in India. This collaboration is expected to strengthen domestic manufacturing, promote local value addition, enhance ease of doing business, and strengthen India's integration with global MedTech value chains. The signing of the MoU was followed by a CEO Roundtable on the theme "MedTech as a Catalyst for Viksit Bharat@2047" chaired by Manoj Joshi. The conference saw senior government officials, industry leaders, and key stakeholders deliberate on strategic priorities to strengthen India's MedTech sector and enhance its global competitiveness. The discussions discussed key policy issues, including procurement from local sources and strengthening of supply chains, R&D, the role of Global Competence Centres (GCCs), talent and workforce development, and opportunities to increase India's participation in global medtech markets. Regulatory and investment priorities were focussed. ]]> https://biospectrumindia.com/news/22/28225/health-ministry-gives-clarion-call-for-hepatitis-mukt-bharat.html https://biospectrumindia.com/news/22/28225/health-ministry-gives-clarion-call-for-hepatitis-mukt-bharat.html Tue, 28 Jul 2026 22:23:59 +0530 The Union Ministry of Health and Family Welfare celebrated World Hepatitis Day 2026, on July 28th, under the global theme "Hepatitis: Let's Eliminate It", marking the completion of eight years of the National Viral Hepatitis Control Programme (NVHCP). Launched on World Hepatitis Day in 2018 under the National Health Mission of the Ministry of Health and Family Welfare, the programme reflects India's commitment to eliminate public health risks to viral hepatitis by 2030, in line with Sustainable Development Goal (SDG) Goal 3.3. Anupriya Patel, Union Minister of State for Health and Family Welfare and Chemicals and Fertilizers delivered the keynote address and reiterated the commitment of the Government of India for a Hepatitis Free India and called upon the Government, States and all stakeholders to make intensive efforts to achieve this goal. The Minister stressed on the importance of vaccination of healthcare workers to prevent occupational infections and called for targeted interventions among high-risk populations to protect vulnerable groups from chronic liver disease and liver cancer.  She also released Information, Education and Communication (IEC) materials, including posters on Hepatitis B and Hepatitis C, highlighting the modes of infection and the services available under the National Viral Hepatitis Control Programme (NVHCP) to disseminate them to the States and UTs. Union Health Secretary Punya Salila Srivastava highlighted the significant progress achieved under the National Viral Hepatitis Control Programme. She informed that more than 21 crore beneficiaries have been screened under this programme, while more than 6 lakh patients have received free treatment. ]]> https://biospectrumindia.com/news/22/28210/cdsco-releases-guidance-document-on-medical-device-software.html https://biospectrumindia.com/news/22/28210/cdsco-releases-guidance-document-on-medical-device-software.html Mon, 27 Jul 2026 12:56:56 +0530 Software role in healthcare is becoming increasingly critical, as a diverse array of products serves various medical and administrative functions across clinical and private settings. Any software, whether alone or in combination, intended by the manufacturer for medical purposes and attracts the definition of medical device under the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017 (MDR-2017) is regulated as ‘medical device.’ The Central Drugs Standard Control Organisation (CDSCO) has released a document to provide guidance to stakeholders (manufacturers, importers and innovators/researchers, etc.) for the submission of application to the Licensing Authority (LA) for obtaining regulatory approvals for Medical Device Software (Medical Device Software) (including In-vitro Diagnostic (IVD) Medical Device Software) under the MDR-2017. This Guidance Document reflects current practices under the MDR-2017 and should not be misconstrued as a new regulatory control on MDSW (including In vitro Diagnostic (IVD) MDSW). Manufacturers of AI-enabled MDSW intended for use in India should demonstrate that device performance has been evaluated in at risk populations, healthcare settings, and operational environments representative of the intended use. As per the document, manufacturers should design MDSW to maintain safe operation during cybersecurity incidents, including partial loss of connectivity, denial of-service conditions, or integrity compromise. In-vitro diagnostic systems, digital pathology solutions, radiology AI systems, and diagnostic decision-support software deployed within healthcare facilities should be designed such that they support ABDM compliant health record generation and exchange, maintain patient consent controls, and enable traceability of diagnostic outputs to registered facilities and authorized healthcare professionals. ]]> https://biospectrumindia.com/news/22/28191/cabinet-approves-chemical-park-scheme-with-total-allocation-of-rs-3030-cr.html https://biospectrumindia.com/news/22/28191/cabinet-approves-chemical-park-scheme-with-total-allocation-of-rs-3030-cr.html Fri, 24 Jul 2026 22:02:05 +0530 The Union Cabinet, chaired by the Prime Minister Narendra Modi, has approved the India Industrial Development Scheme Rasayan or Bhavya-Rasayan Yojana for setting up of three Dedicated Chemical Parks in the country. The scheme was announced in the Union Budget for FY 2026-27. A total financial allocation of Rs 3,030 crore will be made for the scheme, out of which Rs 3,000 crore will be allocated to meet the cost of installation of indoor infrastructure facilities and basic utilities of the park and R. 30 crore will be allocated as administrative expenses. The scheme will be applicable for a period of five years from FY 2026-27 to FY 2030-31. The Central Government will provide grants up to Rs 1,000 crore for each park under the said scheme after contributing a minimum of Rs 500 crore on behalf of the respective State Government. Recognising that the sector produces chemicals and petrochemicals which are used in various industries such as agriculture, textiles, pharmaceuticals, nutraceuticals, construction, automobiles, electronics, by attracting domestic and foreign investments, by launching the Grand Chemicals Scheme, it will help in the growth of the sector by increasing domestic production capacity and creating employment. ]]> https://biospectrumindia.com/news/22/28196/chhattisgarh-draws-rs-992-53-cr-worth-pharma-investment-proposals-in-18-months.html https://biospectrumindia.com/news/22/28196/chhattisgarh-draws-rs-992-53-cr-worth-pharma-investment-proposals-in-18-months.html Fri, 24 Jul 2026 23:27:11 +0530 Riding on policy reforms that earned it the top rank among large states in NITI Aayog's Investment Friendliness Index 2026 for Regulatory Ease and Institutional Environment, Chhattisgarh has received pharmaceutical investment proposals worth Rs 992.53 crore over the past 18 months under its Industrial Development Policy 2024–30, with four projects worth Rs 216 crore already under implementation, signalling that investor interest is translating into on-ground manufacturing activity. The four projects, being developed by 9M India, Shankara Latex Industries, Avila Pharmaceuticals and Vitalis Health Services, are at various stages of implementation. Facilities by 9M India and Shankara Latex Industries are under construction and are expected to become operational soon, while projects by Avila Pharmaceuticals and Vitalis Health Services are also advancing rapidly. For pharmaceutical manufacturing, where investment decisions are cautious and project cycles can be long, this early movement is significant as it reflects progress from investment intent to execution. “Chhattisgarh is consciously diversifying its industrial landscape, and pharmaceuticals are among the new-age sectors we are ready to host at scale. The momentum we're seeing in Nava Raipur, reflected in the investment proposals and projects under implementation, reinforces the confidence investors are placing in Chhattisgarh's readiness for advanced manufacturing and validates our sustained focus on ease of doing business," Chief Minister Vishnu Deo Sai said. Under the Industrial Development Policy 2024–30, pharmaceuticals have been identified as a thrust sector. The policy offers capital assistance linked to investment size, reimbursement of net SGST for up to 12 years, exemptions on electricity duty and stamp duty, and additional benefits for pioneer investors. The objective is to strengthen project viability, support early investors and encourage long-term manufacturing investments in the state. The investment ecosystem has been further strengthened with the recent enactment of the Chhattisgarh Ease of Doing Business Act, 2026, making the state the first in the country to introduce a risk-based regulatory framework aimed at simplifying approvals, reducing compliance burden and enabling faster project implementation. The state's flagship Pharma Park at Nava Raipur is emerging as a key driver of this growth. Spread across nearly 142 acres, the park has been developed with plug-and-play infrastructure, common utilities and logistics connectivity to support pharmaceutical manufacturing. Within just over a year of opening plot allotments, the park has witnessed encouraging investor response, with seven plots already allotted, reflecting steady progress in the development of Nava Raipur's pharmaceutical manufacturing ecosystem. ]]> https://biospectrumindia.com/news/22/28186/govt-advances-research-standardisation-and-quality-assessment-of-herbal-medicines.html https://biospectrumindia.com/news/22/28186/govt-advances-research-standardisation-and-quality-assessment-of-herbal-medicines.html Thu, 23 Jul 2026 23:15:11 +0530 The Drugs Code Commission of India (IPC), an autonomous body under the Ministry of Health and Family Welfare, Government of India, has reinforced its commitment to the vision of a developed Uttar Pradesh-developed India by signing and renewing two Memorandum of Understanding (MoUs) with Dr. Shakuntala Mishra National Rehabilitation University (DSMNRU), Lucknow and CSIR-Central Institute of Medicinal and Aromatic Plants (CSIR-CIMAP). The renewed MoU with CSIR-CIMAP will continue to collaborate in research, standardisation and quality evaluation of herbal medicines. The main objective of the new MoU with DSMNRU is to develop scientific protocols to assess the quality, safety and functionality of assistive devices used by Divyangjan. The collaboration will also support the development of pharmacovigilance training modules in sign language to promote drug safety awareness and reporting of adverse drug reactions among persons with disabilities. Speaking on the occasion, Dr V. Kalaiselvan said that these collaborations will strengthen scientific research, quality standards, and institutional partnerships, helping Uttar Pradesh emerge as a centre of excellence in the field of healthcare and drug quality. He emphasised that such initiatives directly contribute to the shared vision of 'Viksit UP-Viksit Bharat' by improving access to safe, effective, and quality health products. ]]> https://biospectrumindia.com/news/22/28171/icmr-transfers-three-indigenous-biomedical-technologies-for-advancements-in-cancer-and-infectious-disease-solutions.html https://biospectrumindia.com/news/22/28171/icmr-transfers-three-indigenous-biomedical-technologies-for-advancements-in-cancer-and-infectious-disease-solutions.html Tue, 21 Jul 2026 18:40:01 +0530 The Indian Council of Medical Research (ICMR), under its Medical Innovation Patent Mitra initiative, has granted licenses to three indigenous biomedical technologies to leading Indian pharmaceutical and vaccine manufacturers for further development, production and commercialisation. These technologies include SHETA2, an innovative anti-HPV therapeutic candidate for the treatment of cervical intraepithelial neoplasia (CIN), which has been licensed to Emcure Pharmaceuticals. In addition, two next generation vaccine technologies against enteric bacterial infections are included, which have been developed at ICMR-National Institute for Research on Bacterial Infections (ICMR-NIRBI), Kolkata. Their license has been given to Biological E. SHETA2, developed in collaboration with Dr Shaukat Hussain, ICMR National Institute of Cancer Prevention and Research (ICMR-NICPR) and Dr Doris M. Benbrook (Stephenson Cancer Center, University of Oklahoma, USA), is a first-of-its-kind targeted therapeutic drug that selectively destroys HPV-induced pre-cancerous and cervical cancer cells without harming healthy cells. This technology has the potential to provide a safe, affordable, and minimally invasive treatment option for cervical cancer. The two vaccine technologies developed by Dr Santasabuj Das and his team at ICMR's National Institute for Research in Bacterial Infection (ICMR-NIRBI) include: Salmonella typhi, a fusion structure containing outer membrane proteins, has emerged as a promising candidate for the next-generation typhoid vaccine. A regenerative vaccine structure against Salmonella typhi/paratyphi and Shigella infections, designed to provide comprehensive protection against major intestinal bacterial pathogens. Together, these technologies have the potential to strengthen India's efforts in cancer prevention and control of infectious diseases, as well as advance the indigenous development of next-generation therapies and vaccines. ]]> https://biospectrumindia.com/news/22/28155/export-promotion-council-for-medical-devices-inks-mou-with-msme-ministry.html https://biospectrumindia.com/news/22/28155/export-promotion-council-for-medical-devices-inks-mou-with-msme-ministry.html Sun, 19 Jul 2026 15:35:16 +0530 Export Promotion Council for Medical Devices (EPCMD-India) has signed a Memorandum of Understanding (MoU) with the Ministry of Micro, Small and Medium Enterprises (MSME), Government of India.Under this MoU, EPCMD has been designated as an Implementation Agency for the Capacity Building of First Time MSE Exporters (CBFTE) initiative, under the International Cooperation Scheme of the Ministry of MSME.This collaboration is expected to benefit first-time MSME exporters in the medical devices sector by easing the cost of registration with Export Promotion Councils, supporting their entry into export markets, and providing a structured mechanism for reimbursement support through EPCMD. ]]> https://biospectrumindia.com/news/22/28149/st-minister-unveils-roadmap-to-take-indias-bioeconomy-to-700-b-by-2035.html https://biospectrumindia.com/news/22/28149/st-minister-unveils-roadmap-to-take-indias-bioeconomy-to-700-b-by-2035.html Sat, 18 Jul 2026 13:06:42 +0530 Union Minister of State (Independent Charge) for Science & Technology (S&T) Dr Jitendra Singh recently announced the launch of the roadmap for "Making India a Leading Bioeconomy Power by 2035". A central proposal of the roadmap is the creation of a Rs 50,000 crore BioEconomy Growth Fund (2026–2035) to close India’s most dangerous gap - the “valley of death” between proof-of-concept and manufacturing at scale. Anchored within the national RDI framework, this fund would deploy blended finance, catalytic equity and infrastructure support for biomanufacturing, advanced therapeutics, fermentation platforms, biomaterials, diagnostics and synthetic biology. NITI Aayog member Prof. Govardhan Das said that the roadmap aims to take India's bioeconomy to about $700 billion by 2035 with the help of the proposed Bioeconomy Development Fund of Rs 50,000 crore, improved talent pipeline and world-class bio-manufacturing capabilities. He appealed to the industry, researchers and investors to work together towards making India one of the top biotechnology powers in the world. The roadmap proposes a decisive shift from fragmented programmes to National BioMissions with time bound delivery. Flagship efforts being suggested are: GeneIndia - To make affordable gene and cell therapies and precision diagnostics available to Indian patients, built on population-scale genomic capabilities. AgriBio 2.0 - To deliver climate-resilient, farmer-owned crop varieties and quality-assured bio inputs that improve farm profitability and reduce chemical dependence. BioX Foundry - To turn India’s industrial biotech innovations into commercial-scale products, building a globally competitive base of synthetic-biology enterprises. One Health Grid - To enable AI-assisted disease detection and coordinated response to emerging infectious diseases, zoonotic threats and AMR across human, animal and environmental health. Marine Biotechnology - To grow India’s marine-derived exports and coastal bioeconomies through seaweed cultivation, marine bioproducts and blue-economy innovation. BioPharmaNext - To establish India as a global hub for affordable, next-generation biologics, biosimilars, vaccines, and cell and gene therapeutics. This roadmap has been prepared by NITI Frontier Tech Hub (FTH) in consultation with experts and stakeholders. ]]> https://biospectrumindia.com/news/22/28153/cdsco-approves-wegovy-as-first-and-only-glp-1-for-adults-living-with-fatty-liver-disease-in-india.html https://biospectrumindia.com/news/22/28153/cdsco-approves-wegovy-as-first-and-only-glp-1-for-adults-living-with-fatty-liver-disease-in-india.html Sat, 18 Jul 2026 14:23:06 +0530 Novo Nordisk India has announced that the Central Drugs Standard Control Organization (CDSCO) has approved a new indication for Wegovy® (semaglutide injection 2.4 mg), making it the first and only GLP-1 receptor agonists (RA) to be approved both globally and in India for the treatment of noncirrhotic metabolic dysfunction associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis along with a reduced calorie diet and increased physical activity.  MASH is a liver disease that develops due to excess fat buildup in the liver, causing chronic inflammation and liver damage. Two in three Indians have fatty liver disease. It is a silent disease and people often do not have symptoms until the disease has progressed to an advanced stage. Vikrant Shrotriya, Managing Director, Novo Nordisk India, said, “The burden of MASH continues to rise in India, but treatment options are still severely limited. People with MASH face a higher risk of serious liver complications and heart-related disease. That is why we need treatment options that can address these connected health risks. This approval is an important milestone, giving doctors and patients a new option for people at risk of MASH while also helping to address obesity and related heart and metabolic diseases.” Novo Nordisk’s innovator semaglutide, the active pharmaceutical ingredient in Wegovy®, is backed by 50+ clinical trials, 49 million patient years of exposure, and extensive real-world evidence. Innovator semaglutide is manufactured using rDNA technology and is approved by regulatory authorities across 75 countries including the Drugs Controller General of India (DCGI), European Medicines Agency (EMA), United States Food & Drug Administration (US FDA) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan. ]]> https://biospectrumindia.com/news/22/28127/pharmacopoeia-commission-of-india-inks-mou-with-uttar-pradesh-pharmacopoeia-council.html https://biospectrumindia.com/news/22/28127/pharmacopoeia-commission-of-india-inks-mou-with-uttar-pradesh-pharmacopoeia-council.html Wed, 15 Jul 2026 19:15:19 +0530 Taking a significant step towards promoting high-quality healthcare standards and strengthening the regulatory framework, the Pharmacopoeia Commission of India (IPC) has signed a Memorandum of Understanding (MoU) with the Uttar Pradesh Pharma Council (UPPPC).  This strategic collaboration aims to strengthen the pharmaceutical and medical device ecosystem by fostering quality standards, regulatory excellence, innovation, and capacity building. Through this partnership, IPC and UPPPC will work together for strengthening quality standards and regulatory compliance in the pharmaceutical and medical device industries; Promote awareness about Indian Drug Code, Drug Vigilance and Substance Vigilance; Organise joint training programmes, workshops and awareness campaigns for stakeholders; Promote research, innovation, and industry-academia collaboration; Support Small and Medium Enterprises (MSMEs) by providing digital tools for reporting adverse events; Enhancing patient safety through quality assurance and after-sales monitoring initiatives in the market. ]]> https://biospectrumindia.com/news/22/28102/safdarjung-hospital-joins-hands-with-sports-authority-of-india-to-improve-sports-medicine-and-athletes-care.html https://biospectrumindia.com/news/22/28102/safdarjung-hospital-joins-hands-with-sports-authority-of-india-to-improve-sports-medicine-and-athletes-care.html Sat, 11 Jul 2026 11:23:54 +0530 The Sports Injury Centre (SIC) of Safdarjung Hospital under the Ministry of Health and Family Welfare, and the Sports Authority of India (SAI) under the Ministry of Youth Affairs and Sports have signed a Memorandum of Understanding (MoU). The MoU was signed in the presence of Union Health Secretary Punya Salila Srivastava and Secretary, Department of Sports, Ministry of Youth Affairs and Sports, Hari Ranjan Rao. This MoU is a step towards strengthening institutional cooperation to provide comprehensive sports medicine and healthcare services to sportspersons and support staff associated with Sports Authority of India.  This collaboration brings together the medical expertise of SIC and SAI's extensive athlete support network to create a comprehensive and coordinated model for athletes' healthcare. The purpose of this partnership is to improve the quality of sports injury prevention, screening, treatment, rehabilitation and sports science support, so that athletes can perform and maintain their best performance. Apart from medical care, the MoU also envisages cooperation in the areas of sports science, medical education, capacity building, training and research. Together, the two institutes will work on research projects aimed at developing new treatment methods, improving injury prevention strategies, promoting evidence-based sports medicine practice, and promoting scientific innovation to improve the health and performance of athletes. ]]> https://biospectrumindia.com/news/22/28037/health-ministry-develops-strategic-framework-for-maternal-and-newborn-healthcare.html https://biospectrumindia.com/news/22/28037/health-ministry-develops-strategic-framework-for-maternal-and-newborn-healthcare.html Mon, 29 Jun 2026 15:32:58 +0530 Union Minister of Health and Family Welfare Jagat Prakash Nadda released the 'SUMAN Roadmap 2030' during the 16th Conference of the Central Council of Health and Family Welfare (CCHFW), in New Delhi. The roadmap is a comprehensive, multi-pronged strategic framework designed to strengthen maternal and newborn healthcare and accelerate progress towards the Sustainable Development Goals (SDGs) of reducing maternal and newborn mortality by 2030. In view of the need for renewed and targeted action to address the remaining challenges in maternal and newborn health, the SUMAN (Surakshit Matritva Assurance Scheme) Roadmap 2030 has been developed. Although India has made substantial improvements in maternal health in the last decade, persistent gaps continue to hinder further reduction in maternal and neonatal mortality, especially in states where these challenges need special attention. The roadmap goes beyond a uniform approach and provides customised, specific, and evidence-based interventions tailored to the needs of states and districts. This roadmap takes a lifecycle approach and integrates interventions across all stages of care, including prenatal care, antenatal care, perinatal care, and postpartum care. It promotes coordination with nutrition and child health, adolescent health, family planning under the RMNACHA+N framework to ensure integrated service delivery. A key feature of this roadmap is a structured four-step framework for identifying, monitoring and managing high-risk pregnancies during pregnancy, especially high-risk pregnancies in the third trimester, high-risk pregnancies during childbirth, and postpartum high-risk mothers. The framework also includes relevant interventions based on ground level experiences, including transportation challenges, access to tribal and hard-to-reach areas, quality emergency obstetric care, public participation through Suman Panchayats, and emerging challenges such as climate change. The roadmap lays out targeted and time-bound strategies in 130 districts across 13 high-focus states, including Assam, Bihar, Chhattisgarh, Haryana, Jharkhand, Karnataka, Madhya Pradesh, Odisha, Punjab, Rajasthan, Uttar Pradesh, Uttarakhand, and West Bengal, as well as strategies for all States and UTs to sustain progress and achieve saturation in maternal and newborn health services. ]]> https://biospectrumindia.com/news/22/28038/government-proposes-amendment-to-medical-devices-rules-2017.html https://biospectrumindia.com/news/22/28038/government-proposes-amendment-to-medical-devices-rules-2017.html Mon, 29 Jun 2026 15:36:54 +0530 The Ministry of Health and Family Welfare, Government of India, has published a draft gazette notification proposing amendments to the Medical Devices Rules, 2017. It aims to simplify and expedite the licensing process of medical devices while ensuring full compliance with the prescribed standards related to quality, safety and performance. The proposed amendments are aimed at rationalising the timelines for licensing of medical devices of various risk categories. The objective of this initiative is to promote ease of doing business, improve regulatory efficiency and ensure timely availability of high-quality medical devices in the country. Under the Medical Devices Rules, 2017, medical devices have been classified into four categories — Class A, Class B, Class C and Class D — based on risk. These include the highest-risk medical devices in Class D. These rules prescribe statutory timelines for disposal of applications received for grant of licenses of each category of medical devices. The proposed amendments seek to reduce these timelines so that regulatory approvals can be granted more expeditiously without compromising on the established standards of quality, safety and performance. The time limit for licensing of Class B medical devices, including low to medium risk devices such as blood pressure monitors, hypodermic needles and pulse oximeters, has been proposed to be reduced from 140 days to 115 days. Similarly, the time limit for licensing of Class C and Class D medical devices, including high-risk devices such as heart stents, hip and knee implants and implants related to other orthopaedic diseases, is proposed to be reduced from 105 days to 90 days. The amendments to the proposed draft also prescribe clear timelines for each stage of the licensing process. This includes scrutiny of applications, audit by notified bodies, verification of compliance and process for issuance of licenses. This is expected to bring in greater transparency, predictability and efficiency in the regulatory regime. This will benefit the medical devices industry as well as the patients as they will have faster access to quality medical devices. The draft notification has been placed in the public domain inviting suggestions and comments from all stakeholders. ]]> https://biospectrumindia.com/news/22/28032/health-ministry-simplifies-procedure-for-import-of-drugs.html https://biospectrumindia.com/news/22/28032/health-ministry-simplifies-procedure-for-import-of-drugs.html Sat, 27 Jun 2026 16:11:34 +0530 In a significant step towards promoting research and innovation and enhancing ease of doing business in the pharmaceutical sector, the Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945 to simplify the procedure for obtaining permission for import of drugs for examination, test or analysis. This is commonly known as Form 11. The amendment introduces an acknowledgement-based system for import of all drugs in small quantities for analytical and non-clinical testing purposes. Under the revised provisions, applicants intending to import such drugs will be required to submit a prior intimation form and may import the drug based on the acknowledgement generated upon submission of such intimation. The simplified procedure shall be applicable for import of drugs for analytical and non-clinical testing, except for certain drugs belonging to the categories of sex hormones, cytotoxic drugs, beta lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic substances, which shall continue to require prior licensing. It may be recalled that the Ministry of Health and Family Welfare had already carried out amendments to the New Drugs and Clinical Trials Rules, 2019 in January 2026 introducing a similar notification system for domestic test licences. The present proposed amendment expands it to imports also. The amendment is expected to significantly reduce the compliance burden on applicants by eliminating licensing requirements for importing small quantities of drugs for testing or R&D purposes. This will play a substantial role in deregulating the R&D sector in pharmaceuticals and enable start-ups and industries to quickly initiate testing or analysis.  The online intimation system will offer a seamless and instant gateway for the stakeholders. The initiative is expected to provide a major boost to research and innovation in the country while facilitating more efficient and streamlined regulatory process. ]]> https://biospectrumindia.com/news/22/28027/health-ministry-extends-qr-code-based-drug-product-identification-framework.html https://biospectrumindia.com/news/22/28027/health-ministry-extends-qr-code-based-drug-product-identification-framework.html Thu, 25 Jun 2026 16:10:56 +0530 In a significant step towards strengthening the quality, safety and purity of India's pharmaceutical supply chain, the Union Ministry of Health and Family Welfare, Government of Ind,a has approved the Drug Rules, to expand the scope of Schedule H2 and bring additional categories of drugs under the QR code-based track and trace framework. Amendments have been notified in 1945. Under the amended provisions, all vaccines, antimicrobial, narcotic and psychiatric drugs and all anti-cancer drugs covered under the Narcotic Drugs and Psychiatric Substances (NDPS) Act, 1985 have been included in Schedule H2 of the Drugs Rules, 1945. As per this amendment, the manufacturers of these medicines will be mandated to print or affix the bar code or quick response (QR) code on the primary packaging label of the product or on the secondary packaging label if there is insufficient space. The QR code will store information that can be used to facilitate the authentication and verification of the product through software applications. The QR code will include key product information, including the unique product identification code, generic and brand name, manufacturer's name and address, batch number, manufacturing and expiry dates, manufacturing license number, and where applicable, details of the accessories. The QR code-based identification requirement was earlier applicable to the top 300 pharmaceutical brands in the country. The present amendment substantially expands its scope to include all vaccines, antimicrobial drugs, anti-cancer drugs and narcotic and psychiatric drugs, thereby widening the scope of detection and strengthening safeguards against the proliferation of spurious and substandard drugs. The improved product identification framework will facilitate certification of drugs at various stages of the supply chain and enable better tracking and validation of pharmaceutical products. This measure is expected to strengthen regulatory oversight and aid efforts to curb the distribution of spurious drugs in the market. It will also contribute to the national fight against antibacterial resistance (AMR) by enabling better detection and monitoring of counterfeit and substandard antibacterial products. Keeping in view the need to give adequate time to the industry and other stakeholders for implementation, the Ministry has prescribed phased timelines for compliance. The provisions relating to vaccines, narcotic and psychiatric drugs and anti-cancer drugs will come into effect from 1st July 2027, while those relating to antimicrobial drugs will come into effect from 1st July 2028. ]]> https://biospectrumindia.com/news/22/27995/health-ministry-bans-manufacture-sale-and-distribution-of-16-fixed-dose-combinations-fdcs.html https://biospectrumindia.com/news/22/27995/health-ministry-bans-manufacture-sale-and-distribution-of-16-fixed-dose-combinations-fdcs.html Sat, 20 Jun 2026 18:35:26 +0530 In a significant step towards protecting public health and promoting rational use of drugs, the Ministry of Health and Family Welfare has issued a notification under Section 26A of the Drugs and Cosmetics Act, 1940 prohibiting the manufacture, sale and distribution for human use of 16 Fixed Dose Combinations (FDCs). These notifications have come into force with immediate effect. This decision has been taken following the directions of the Supreme Court, which mandated a comprehensive review of the fixed dose combinations available in the country. In compliance with these directives, the Drug Technical Advisory Board (DTAB) constituted an expert committee to investigate various FDCs and identify FDCs that are irrational, lack medical justification, or may pose a risk to human health. All State Drug Controllers, Regulatory Authorities and Enforcement Agencies have been directed to ensure strict implementation and compliance of the notifications. Manufacturers, importers, distributors and other stakeholders have also been advised to take necessary corrective measures to comply with the provisions of the law. The following is a detailed list of restricted fixed dose combinations: Acetyl salicylic acid + ethoheptazine Aloe vera extract + allantoin + alphatocopherol acetate + D-panthenol + vitamin A Aloe vera extract + vitamin E + dimethicone + glycerin Aloe Vera + Jojoba Oil + Vitamin E Aloe vera + orange oil Aloe vera + jojoba oil + wheat germ oil + tea tree oil Aloe vera + vitamin E + herbal Dicyclomine + Paracetamol + Clidinium Bromide Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide Glyclavazide + Chromium Picolinate Paracetamol + lignocaine Amoxicillin + Serratiopeptidase + Lactobacillus sporogenes Amoxicillin + cloxacillin + lactic acid bacillus + serratiopeptidase Amoxicillin + Serratiopeptidase Cefadroxyl + probenecid Cefuroxime + Serratiopeptidase ]]> https://biospectrumindia.com/news/22/27998/karnataka-govt-strengthens-innovation-ecosystem-with-new-investments.html https://biospectrumindia.com/news/22/27998/karnataka-govt-strengthens-innovation-ecosystem-with-new-investments.html Sat, 20 Jun 2026 22:30:45 +0530 Karnataka is strengthening startup ecosystems beyond Bengaluru through strategic investments in regional innovation infrastructure and entrepreneurship support.With an investment of Rs 9.51 crore, the K-Combinator Accelerator in Mangaluru will provide early-stage startups with access to mentorship, industry networks, market opportunities, and growth support, further advancing innovation-led development across the State. According to the Global Startup Ecosystem Report (GSER) 2026, one of the world’s most authoritative benchmarks for startup ecosystems, based on data from 5.5 M+ companies across 350+ innovation ecosystems, Karnataka stands at no. 15 out of the top 40 global startup ecosystems. Karnataka continues to invest in the infrastructure that enables scientific discovery, innovation, and translational research.With an investment of Rs 6.8 crore at the Centre for Human Genetics, Bengaluru, the Government of Karnataka is strengthening capabilities in advanced biotechnology research, supporting emerging areas such as genomics, gene therapy, and life sciences innovation.These investments are critical to fostering world-class research ecosystems and reinforcing Karnataka’s position as India’s biotechnology capital. ]]> https://biospectrumindia.com/news/22/27983/india-and-france-launch-atl-bridge-to-support-young-innovators.html https://biospectrumindia.com/news/22/27983/india-and-france-launch-atl-bridge-to-support-young-innovators.html Wed, 17 Jun 2026 16:43:25 +0530 Guided by the shared resolve of Prime Minister Narendra Modi and President of the French Republic Emmanuel Macron to deepen innovation-led cooperation between India and France, Atal Innovation Mission, NITI Aayog, and La Fondation Dassault Systèmes have established the India-France ATL Bridge.The initiative will enable collaboration among young innovators in both countries and establishes the first School Innovation Lab in France, inspired by India’s Atal Tinkering Lab framework.The ATL Bridge will serve as a strategic platform for cross-border innovation programmes, entrepreneurial exchanges, knowledge sharing, capacity building and joint innovation activities.By enabling young learners to co-create solutions to real-world challenges, the initiative strengthens early-stage innovation capabilities and deepens bilateral innovation cooperation between India and France. The ATL Bridge initiative forms part of the India–France Innovation Year 2026, reflecting both countries’ commitment to expanding cooperation in science, technology and education.  The model builds on India’s experience with Atal Tinkering Labs, which introduce students to design thinking, robotics, electronics, 3D design and emerging technologies such as artificial intelligence. ]]> https://biospectrumindia.com/news/22/27975/govt-enhances-regulatory-control-over-cough-medicines.html https://biospectrumindia.com/news/22/27975/govt-enhances-regulatory-control-over-cough-medicines.html Tue, 16 Jun 2026 13:11:13 +0530 The Ministry of Health and Family Welfare, Government of India, has notified amendments to the Drugs Rules, 1945 vide Gazette Notification GSR 927 (E) dated 29th December 2025. It was published in the Gazette of India Extraordinary on the date of December 30, 2025, wherein the word "syrup" under the head "class of drugs" under Schedule K, No. 13, Entry 7 is omitted. Schedule 'K' of the Drugs Rules, 1945 exempts certain types of drugs from certain provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. Prior to this amendment, Entry No. 13 of Schedule 'K' allowed sale of cough medicines in villages with population less than 1,000 for which certain provisions relating to retail sale license were not required. Due to omission of the word "syrup" from the said entry, this exemption shall not apply to syrups for cough medicines. Consequently, the sale and distribution of cough syrups in small villages shall now be mandatorily done only through pharmacies duly licensed in accordance with the Drugs and Cosmetics Act, 1940 and Rules framed thereunder. The amendment has been made to strengthen regulatory oversight on syrup formulation process and to align the draft exemption with contemporary public health and safety requirements. It is expected that this measure will promote responsible distribution and sale of cough medicines, as well as ensure better compliance with regulatory standards across the country. Manufacturers, distributors and retailers of cough medicines are advised to ensure strict compliance of licensing and regulatory requirements applicable under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945. ]]> https://biospectrumindia.com/news/22/27959/st-minister-calls-for-further-strengthening-industry-academia-partnership.html https://biospectrumindia.com/news/22/27959/st-minister-calls-for-further-strengthening-industry-academia-partnership.html Sun, 14 Jun 2026 13:15:46 +0530 Union Minister of State (Independent Charge) for the Ministries of Science and Technology (S&T) and Earth Sciences, Dr Jitendra Singh launched a programme to facilitate research institutes to rapidly convert scientific knowledge into market-ready solutions and outcomes for national development. He stressed the need for deeper collaboration between industries and startups. Addressing the Industry Engagement Session on the sidelines of RISE Conclave 2026 in Bengaluru, the Minister said that India has entered a phase where scientific progress must be judged on the basis of its social and economic impact. He said that laboratories, academic institutions and industries have to work in coordination so that innovations are not limited to proof-of-concept testing only, but reach the end users at large. Underlining the commitment of the Government to create an ecosystem that fosters innovation, Dr Jitendra Singh urged the industry representatives to openly share the challenges in working with public funded research institutions. Dr Jitendra Singh said participation of industries should not start from the stage of conceptualisation of research projects, but after the technology matures. He said this will help in adapting scientific research to market requirements, promoting technology transfer and improving the chances of business success. The Minister called upon the industry leaders to actively engage with research institutions and partner in determining the scientific priorities of the country. ]]> https://biospectrumindia.com/news/22/27945/astrazeneca-receives-cdsco-approval-for-trastuzumab-deruxtecan-in-combination-with-pertuzumab-for-breast-cancer-treatment.html https://biospectrumindia.com/news/22/27945/astrazeneca-receives-cdsco-approval-for-trastuzumab-deruxtecan-in-combination-with-pertuzumab-for-breast-cancer-treatment.html Thu, 11 Jun 2026 17:08:05 +0530 AstraZeneca Pharma India Ltd. (AZPIL), a global, science-led biopharmaceutical company, has announced that the Central Drugs Standard Control Organisation (CDSCO) has approved an additional indication for Trastuzumab Deruxtecan 100 mg/5 mL vial lyophilised powder for concentrate for solution for infusion, in combination with Pertuzumab as a first-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer. Breast cancer remains one of the most common cancers affecting women worldwide, and HER2-positive breast cancer is among its most aggressive forms. In India, HER2-positive breast cancer, defined by HER2 gene amplification or protein overexpression, is estimated to account for approximately 12% to 19% of breast cancer cases. In the metastatic setting, unmet need remains significant. Despite advances in care, no new first-line therapies have enhanced outcomes for patients with HER2-positive metastatic breast cancer in recent years. In addition, approximately one-third of patients treated in the first-line setting do not go on to receive second-line therapy, highlighting the importance of using the more effective treatment early in the course of disease. Praveen Rao Akkinepally, Country President and Managing Director, AstraZeneca Pharma India Limited said, “This approval marks an important step forward for patients with unresectable or metastatic HER2-positive breast cancer in India, where the need for more effective treatment options in the first-line setting remains high." ]]> https://biospectrumindia.com/views/22/27921/operation-toofan-why-kerala-is-launching-its-biggest-anti-drug-crackdown-now.html https://biospectrumindia.com/views/22/27921/operation-toofan-why-kerala-is-launching-its-biggest-anti-drug-crackdown-now.html Tue, 09 Jun 2026 10:42:52 +0530 Less than a month after neighbouring Tamil Nadu unveiled its ambitious Drug-Free Tamil Nadu Campaign to dismantle narcotics networks and curb the influence of organised drug syndicates, Kerala has announced its own sweeping offensive against the growing drug menace. The launch of Operation Toofan: The Narco Hunt on June 2, 2026, marks one of the most extensive anti-narcotics campaigns undertaken by any state government in South India in recent years. The timing is significant. Both Kerala and Tamil Nadu recently went to the polls against a backdrop of growing public concern over drug abuse, youth addiction, organised crime and the spread of synthetic narcotics. Against this backdrop, the Kerala government is seeking to demonstrate that it is prepared to confront a problem that many law-enforcement officials and public-health experts believe has become deeply entrenched in parts of the state. The decision to launch Operation Toofan is not merely a reaction to rising crime statistics. It underscores a broader recognition that Kerala's drug problem has evolved from an isolated law-and-order challenge into a complex social, economic and public-health crisis. Synthetic drugs such as methamphetamine and methylenedioxymethamphetamine (MDMA) have progressively replaced traditional narcotics in trafficking networks. Their high value, ease of transportation and growing popularity among younger users have made them particularly difficult to combat. Kerala's extensive coastline, strong connectivity with Gulf countries and high levels of interstate mobility have further complicated enforcement efforts. Why Now? The immediate trigger for Operation Toofan is the steady rise in narcotics-related cases despite years of intensified enforcement. Kerala recorded 36,314 cases under the Narcotic Drugs and Psychotropic Substances Act, 1985, in 2025, compared with 27,530 cases in 2024. Earlier National Crime Records Bureau data had already shown Kerala leading the country in the registration of narcotics-related cases. Government officials argue that these figures reflect both the scale of the problem and the intensity of enforcement efforts. However, they also reveal an uncomfortable reality: despite thousands of arrests, repeated crackdowns and major seizures, trafficking networks continue to adapt and evolve. The concern is particularly acute because the nature of trafficking has changed. What was once largely associated with cannabis cultivation and local distribution networks now increasingly involves sophisticated interstate syndicates, international smuggling channels and synthetic drug laboratories. Intelligence agencies have repeatedly warned that Kerala is no longer merely a transit route but is becoming an important market for synthetic narcotics. The initiative marks a strategic shift from reactive policing towards a more integrated approach involving prevention, intelligence gathering, technological surveillance, rehabilitation and inter-agency coordination. What Has Kerala Done So Far? The state government enters Operation Toofan with a substantial record of anti-narcotics activity. One of the most visible initiatives was Operation D-Hunt, launched by the Kerala Police in 2025 under the supervision of the Additional Director General of Police (Law and Order). The operation involved extensive inspections, surveillance and coordinated raids across districts. In one major statewide drive, police screened more than 1,700 suspects, registered dozens of cases and arrested nearly 80 individuals. Meanwhile, central agencies have played an increasingly important role. The Directorate of Revenue Intelligence launched Operation Chakravyuh in May 2026, targeting trafficking networks operating through courier systems, airports and interstate routes. The operation led to the seizure of more than 24 kilograms of narcotics, including methamphetamine, methaqualone and hashish oil, and resulted in the arrest of key operatives. During financial year 2025-26, the Directorate of Revenue Intelligence's Kochi unit alone reported seizures worth approximately Rs 70.8 crore and arrested 21 individuals under narcotics laws. Perhaps the most dramatic success came through the Narcotics Control Bureau's Operation Samudragupt, launched in 2022 to target maritime trafficking routes originating from Afghanistan and Pakistan. Working with the Indian Navy and other security agencies, the operation resulted in the seizure of approximately 3.2 tonnes of methamphetamine, 529 kilograms of hashish and 500 kilograms of heroin in a series of maritime interceptions. The methamphetamine seizure was the largest in India's history and carried an estimated value of around Rs 15,000 crore. These achievements have significantly enhanced Kerala's reputation as a state willing to take aggressive action against narcotics networks. Anti-Narcotics Task Forces, Narcotic Drugs and Psychotropic Substances coordination cells and intelligence-sharing mechanisms have also been strengthened over the past decade. Why Have These Successes Not Been Enough? Despite these achievements, several structural weaknesses remain. First, a significant proportion of narcotics cases involve users and low-level peddlers rather than major traffickers. Critics argue that while enforcement statistics appear impressive, they often do not reflect the dismantling of large criminal networks that control supply chains and finances. Second, synthetic drugs are easier to conceal and distribute than traditional narcotics. Small quantities can generate enormous profits, making interdiction difficult. Third, organised crime groups increasingly use encrypted messaging applications, online marketplaces and darknet platforms, creating challenges for traditional law-enforcement methods. Fourth, demand remains high, particularly among younger populations. Enforcement may disrupt supply temporarily, but unless addiction and demand are addressed, traffickers often find new routes and markets. These realities help explain why Kerala has chosen to move beyond conventional raids and arrests towards a more technology-driven and coordinated strategy. What Makes Operation Toofan Different? The campaign adopts a whole-of-government approach to the narcotics problem. Unlike earlier initiatives that were largely police-driven, the new campaign integrates the Kerala Police, Excise Department, Health Department and Education Department under a unified command structure led by a designated nodal officer. The initiative incorporates several technology-driven interventions: Anonymous mobile applications allowing citizens to report drug activity confidentially.• WhatsApp-based reporting and intelligence systems.• Wastewater analysis to identify areas with high levels of drug consumption.• Drone-assisted surveillance in vulnerable locations.• Dedicated cyber teams to track online narcotics transactions and darknet marketplaces.• Real-time intelligence sharing between agencies. The education sector has also been brought directly into the campaign. Schools and colleges will be required to implement awareness programmes, while authorities will increase monitoring around educational institutions. The government intends to strictly enforce prohibitions on the sale of tobacco products and narcotics near schools. In addition, Operation Toofan places greater emphasis on financial investigations. Authorities have indicated that vehicles, properties and other assets linked to drug trafficking will be targeted through confiscation proceedings under existing legal provisions. This shift signals a growing recognition that dismantling the financial foundations of organised crime may be more effective than merely arresting individual offenders. Budget Allocation: Is It Enough? Ambitious enforcement strategies, however, require sustained financial backing. This raises an important question: whether Kerala's current budgetary commitments are sufficient to support the long-term goals of Operation Toofan. Kerala has already committed substantial resources to anti-drug initiatives, but questions remain about whether existing allocations are adequate. The state government allocated approximately Rs 15 crore for anti-narcotics activities and around Rs 9.43 crore for the Vimukthi Mission's de-addiction and rehabilitation programmes. The allocations support awareness campaigns, counselling centres, detoxification facilities and enforcement operations. While these allocations demonstrate political commitment, they appear relatively modest when viewed against the scale of the challenge. Kerala's economy is estimated to be worth approximately Rs 14.27 lakh crore in 2025-26. Even a conservative estimate suggesting that drug abuse imposes economic costs equal to one per cent of state output would imply annual losses exceeding Rs 14,000 crore. The current anti-drug budget therefore represents only a tiny fraction of the broader economic burden associated with substance abuse. The Hidden Economic Cost of Drugs The economic impact of narcotics extends far beyond drug seizures and police operations. Healthcare systems bear the cost of treating addiction, overdoses, psychiatric complications and the long-term health consequences associated with substance abuse. Law-enforcement agencies incur expenses related to investigations, surveillance operations, prosecutions and incarceration. With more than 30,000 narcotics-related cases being registered annually, the cumulative burden on police stations, courts and prisons is substantial. Productivity losses may be even greater. Drug addiction affects educational outcomes, labour-force participation and workplace efficiency. Individuals suffering from addiction often experience prolonged periods of unemployment, reduced earnings and declining productivity. Families often face additional financial burdens arising from caregiving responsibilities, treatment expenses and lost income. When these factors are combined, the total economic burden is likely to run into several thousand crores of rupees annually. While no comprehensive estimate currently exists for Kerala, applying international benchmarks suggests that the economic burden could plausibly approach one to two per cent of state output. Is More Funding Needed? Many public-health and law-enforcement experts contend that additional investment will be necessary. If Operation Toofan is to achieve its objectives, Kerala may eventually need to invest significantly more in: Modern forensic laboratories.• Cybercrime and darknet investigation capabilities.• Intelligence collection and data analytics.• Expansion of rehabilitation and de-addiction facilities.• Community-based prevention programmes.• School and college awareness initiatives.• Training for specialised narcotics investigators.• Witness protection and financial investigation units. The state's existing de-addiction infrastructure remains limited relative to the potential scale of demand. Without stronger treatment and rehabilitation systems, enforcement alone may simply recycle users through the criminal justice system rather than addressing the underlying causes of addiction. The Road Ahead Taken together, these measures constitute Kerala's most comprehensive anti-drug initiative to date. They build upon years of enforcement successes, including major seizures by the Kerala Police, Directorate of Revenue Intelligence and Narcotics Control Bureau. More importantly, they reflect a growing understanding that narcotics trafficking is not merely a policing issue but a challenge that affects public health, economic productivity, education and social stability. The ultimate measure of success will not be the number of arrests or seizures but whether authorities can move beyond targeting users and low-level peddlers to dismantling major trafficking syndicates, disrupting financial networks, reducing drug availability and expanding access to rehabilitation. The government's ambition is clear: to strike at the roots of a drug economy that has become increasingly sophisticated and deeply embedded. Achieving that objective will require sustained political commitment, stronger institutional coordination, adequate funding and a careful balance between robust enforcement and compassionate rehabilitation. For Kerala, the stakes are high. The battle against narcotics is no longer simply about law and order. It is about protecting public health, safeguarding economic growth and preventing a generation of young people from being drawn into addiction and organised crime. Operation Toofan is the state's most ambitious attempt yet to meet that challenge.   Narayan Kulkarni ]]> https://biospectrumindia.com/news/22/27926/10-countries-come-together-to-draw-up-roadmap-for-global-south-on-responsible-ai.html https://biospectrumindia.com/news/22/27926/10-countries-come-together-to-draw-up-roadmap-for-global-south-on-responsible-ai.html Tue, 09 Jun 2026 19:12:28 +0530 Under India's BRICS Presidency 2026, the Indian National Science Academy (INSA) recently organised the first meeting of the BRICS Science Academy Forum 2026. The virtual forum on the theme "Using AI for Sustainable Development and Strengthening Global South Cooperation" will feature 10 countries- Brazil, China, Egypt, Ethiopia, Indonesia, Russia, South Africa, Belarus. The science academies of Nigeria and Vietnam – participated to advance a joint declaration on responsible and equitable AI development. The participating academies presented targeted recommendations to make the declaration more effective: China (Chinese Academy of Sciences) called for collaborative AI readiness criteria, scientific data-sharing frameworks, open-source infrastructure, and responsible AI evaluation mechanisms addressing bias, reliability, and local context Egypt (ASRT) emphasised the potential of AI for food security, healthcare, education, energy, and climate change, and called for greater investment in research, capacity building, and equitable AI deployment Indonesia emphasised the role of AI in disaster risk management, mitigating climate change, early warning systems, reduction of greenhouse gases, and sustainable agriculture. Ethiopia advocated higher education and research partnerships, as well as dedicated cooperation on cybersecurity, digital security and combating cross-border cybercrime Vietnam proposed the establishment of joint task forces, thematic working groups, and shared digital public infrastructure with joint training programs to address the gaps in AI skills Nigeria emphasised the importance of advancing the applications of AI for scientific innovation, governance, and national development priorities South Africa discussed the role of AI for future generations, expressed concerns about cost and social science dimensions, and supported open-source AI models Belarus emphasised the responsible use of AI, with a special emphasis on healthcare innovation, data security, and advanced cybersecurity measures in the AI era The suggestions made in the meeting will be incorporated in the revised manifesto. Dr Brajesh Pandey, Executive Director, Indian National Science Academy announced that delegations from BRICS countries and partner countries will gather in person for the second meeting on 22-23 July 2026 at IIT Hyderabad, where the declaration is expected to be finalised.   ]]> https://biospectrumindia.com/news/22/27907/icmr-launches-report-to-strengthen-first-in-human-phase-1-clinical-trials-in-india.html https://biospectrumindia.com/news/22/27907/icmr-launches-report-to-strengthen-first-in-human-phase-1-clinical-trials-in-india.html Thu, 04 Jun 2026 18:51:09 +0530 The Indian Council of Medical Research (ICMR) recently organised the “1st ICMR Annual Clinical Trial Meet 2026”, under the theme “International Clinical Trials Day: Focus on Integrative Medicine Clinical Trials.”  The national-level event served as a significant platform for deliberations on strengthening India’s clinical trial ecosystem and advancing evidence-based integrative medicine research in the country. The meet brought together policymakers, scientists, clinicians, researchers, regulatory authorities and experts from diverse fields to discuss emerging opportunities, ethical frameworks, regulatory pathways and innovations in clinical research. One of the major highlights of the event was the presentation of findings from the ICMR-CCRAS multicentric Phase III Randomised Controlled Trial (RCT) on Iron Deficiency Anaemia. The study evaluated integrative approaches for managing anaemia, a major public health concern in India. The event also witnessed the launch of the report titled “Advancing First-in-Human Phase 1 Clinical Trials in India: A Delphi Study on Regulatory Pathways and Opportunities.” The report was developed through a two-round consultation involving 37 experts from the pharmaceutical industry, Contract Research Organisations (CROs), academia and national regulatory agencies. The study identified major bottlenecks affecting the advancement of early-phase clinical trials in India and recommended measures including strengthening regulatory capacity, streamlining approval processes and enhancing coordination among agencies to support innovation-driven clinical research in the country. Another important milestone during the event was the release of the “Operational Guidelines for Single Ethics Review of Multicentre Research in India,” aimed at strengthening and harmonising ethical review mechanisms for multicentre research studies nationwide.   ]]> https://biospectrumindia.com/news/22/27908/govt-announces-anrf-portal-for-training-in-patent-filing-and-research-paper-writing.html https://biospectrumindia.com/news/22/27908/govt-announces-anrf-portal-for-training-in-patent-filing-and-research-paper-writing.html Thu, 04 Jun 2026 18:57:51 +0530 In a major step towards strengthening India's research ecosystem, Union Minister of State (Independent Charge) for Science & Technology Dr Jitendra Singh has announced an Anusandhan National Research Foundation (ANRF)-supported digital portal aimed at facilitating training in patent filing support and research paper writing assistance for researchers, students and innovators across the country. Dr Jitendra Singh said that the newly announced portal will serve as an important capacity-building resource for researchers and young innovators by providing structured support in scientific writing, publication processes, intellectual property protection and patent-related procedures. He noted that improving access to such resources would strengthen the quality of research output, enhance innovation outcomes and help researchers translate scientific work into publications and intellectual property assets. Emphasising the need for greater coordination among scientific departments and institutions, Dr Jitendra Singh said that scientific organisations working under different departments must function in a collaborative and integrated manner to maximise national outcomes from research, innovation and public investments in science and technology. Reiterating the growing importance of science communication, Dr Jitendra Singh called for a more coordinated outreach strategy across scientific departments. He stressed the need to utilise digital platforms, social media and emerging communication tools to present scientific achievements in a manner that is accessible to citizens, students, startups and researchers. He also suggested exploring common communication platforms to improve dissemination of scientific success stories and innovation outcomes across the scientific ecosystem.   ]]> https://biospectrumindia.com/news/22/27888/cdsco-grants-marketing-authorisation-to-wockhardts-drug-zaynich-for-treatment-of-complicated-utis-.html https://biospectrumindia.com/news/22/27888/cdsco-grants-marketing-authorisation-to-wockhardts-drug-zaynich-for-treatment-of-complicated-utis-.html Mon, 01 Jun 2026 19:36:33 +0530 Mumbai-based Wockhardt has announced that the Central Drugs Standard Control Organisation (CDSCO) has granted authorisation for the import and marketing of its indigenously discovered and developed, first-in-class breakthrough antibiotic, Zaynich® (Zidebactam / Cefepime) in India. The approval is for the treatment of adult patients (≥18 years) with complicated urinary tract infections (cUTI), including pyelonephritis, as well as cases with concurrent Gram negative bacteremia. The approval is supported by results from the pivotal ENHANCE-1 study, a multinational, randomized, double-blind Phase 3 clinical trial evaluating the efficacy and safety of Zaynich® compared with meropenem in patients with cUTI, including pyelonephritis. ZAYNICH® is an injectable antibiotic comprising of a β-lactam enhancer antibiotic, Zidebactam and Cefepime, a cephalosporin antibacterial drug. Zidebactam selectively inhibits penicillin-binding protein-2 (PBP2) while Cefepime primarily targets penicillin-binding protein-3 (PBP3) in Gram negative bacterial pathogens. Cefepime and zidebactam work together by binding to multiple PBPs, leading to bacterial killing. ZAYNICH has also received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the US FDA. ]]> https://biospectrumindia.com/news/22/27889/icmr-releases-comprehensive-guidelines-for-establishment-of-biorepositories.html https://biospectrumindia.com/news/22/27889/icmr-releases-comprehensive-guidelines-for-establishment-of-biorepositories.html Mon, 01 Jun 2026 19:43:38 +0530 The Indian Council of Medical Research (ICMR) has released comprehensive guidelines to create a harmonised framework for biorepository governance across its institutes, building on the wide range of biological specimens available nationwide.The guidelines provide a clear structure for setting up and managing biorepositories, with standardised practices for the collection, storage, management, and sharing of biological specimens. It will focus on quality systems, biosafety and biosecurity, data management, and ethical and regulatory compliance, while allowing flexibility based on the type of specimens at each institute; Establish a uniform system for the use of biospecimen resources in India to support innovation; Develop biorepositories for systematic biospecimen collection, preservation, and long-term research use.The objectives rely on standardising processes through integrated information systems for collection, storage, sharing, and use of biological materials across ICMR institutes; ensuring availability of well-characterised, high-quality biospecimens for research, education, and product development; building national capacity by strengthening expertise in biorepository management and operations.These guidelines mark an important step towards strengthening India’s biomedical research ecosystem through consistent and high-quality biospecimen management. ]]> https://biospectrumindia.com/news/22/27856/centre-and-west-bengal-to-initiate-collaborative-clinical-and-drug-trial-research-on-cancer-and-antimicrobial-therapies.html https://biospectrumindia.com/news/22/27856/centre-and-west-bengal-to-initiate-collaborative-clinical-and-drug-trial-research-on-cancer-and-antimicrobial-therapies.html Tue, 26 May 2026 19:39:06 +0530 Minister of State (Independent Charge) for Science and Technology (S&T), Dr Jitendra Singh held a detailed meeting with West Bengal Chief Minister Suvendu Adhikari in Kolkata. After the talks, it has been decided to implement all major central schemes related to science, research, innovation and startups in West Bengal with immediate effect. Two important decisions of regional importance were also taken in the meeting- To initiate a dedicated study on arsenic poisoning in the affected districts of West Bengal through CSIR institutes; and collaborative clinical and drug trial research on cancer and antimicrobial therapies involving premier scientific institutions, government medical colleges, cancer hospitals and AIIMS medical network. Directors and representatives of scientific institutions working under the Ministry of Science and Technology in West Bengal attended the meeting. The main topic of discussion was to create a coordinated framework between the Central and State Government for scientific research, innovation, biotechnology, clinical studies, startup promotion and expansion of science education across the state. Dr Jitendra Singh said that West Bengal has a strong scientific and academic ecosystem. In this, institutions under the Ministry of Science and Technology are functioning across the state and contributing to advanced research areas. The meeting mainly discussed the student-centric and women-centric schemes of the Department of Science and Technology in schools and colleges of West Bengal. It was decided to expand flagship programmes like INSPIRE, INSPIRE Standard, Vigyan Jyoti, Kiran and WISE and implement them in a coordinated manner to strengthen scientific temper, innovation and participation of students and women in S&T areas. The Union Minister said that integration of Central Scientific Schemes with educational institutions in West Bengal will help in creating a strong foundation for innovation, scientific education and research-oriented talent development among the youth.   ]]> https://biospectrumindia.com/news/22/27834/india-and-norway-deepen-strategic-partnership-in-science-and-innovation-.html https://biospectrumindia.com/news/22/27834/india-and-norway-deepen-strategic-partnership-in-science-and-innovation-.html Tue, 19 May 2026 21:19:40 +0530 While bilateral relations between India and Norway have strengthened during the visit of Prime Minister Narendra Modi to Norway, the Council of Scientific and Industrial Research (CSIR) under the Department of Scientific and Industrial Research (DSIR), Government of India signed Memorandums of Understanding (MoUs) with Norway, to strengthen cooperation in the areas of science, technology, innovation and sustainable development.  The agreements were signed with senior representatives from the partner institutions of Norway on behalf of DSIR/CSIR under the leadership of Dr N. Kalaiselvi, Director General, CSIR and Secretary, DSIR. The MoUs aim to expand India-Norway relations in the areas of research, innovation and technology development, as well as promote institutional partnerships, startup and industry collaborations, academic collaborations, and sustainable development initiatives in both countries. The MoU between DSIR/CSIR and the Research Council of Norway (RCN) aims to promote cooperation in research, technology development, innovation and capacity development.  CSIR also signed an agreement for cooperation (2026-2029) with Norway's premier independent research organisation Stiftelsen SINTEF (SINTEF) under the framework of the MoU issued since 2014. The agreement focuses on waste generation and sustainable transition through joint research and innovation programmes in areas such as bio-based processes and materials, innovation hubs, marine energy (including offshore wind and hybrid systems), carbon capture, storage and utilisation, and conversion of waste into usable materials. An agreement was also signed on cooperation between CSIR institutes and institutes of SINTEF for a specific project regarding marine energy and offshore wind energy. A Joint Declaration of Intent was signed between CSIR, Academy of Scientific and Innovative Research (ACSIR) and Norwegian University of Science and Technology (NTNU) titled "Science, Technology and Innovation Cooperation for Green Transition".  In another significant development, CSIR-National Geophysical Research Institute (CSIR-NGRI) has signed a five-year Memorandum of Understanding with Emerald Geomodelling. ]]> https://biospectrumindia.com/news/22/27822/cm-vijay-declares-war-on-synthetic-drugs-in-tamil-nadu.html https://biospectrumindia.com/news/22/27822/cm-vijay-declares-war-on-synthetic-drugs-in-tamil-nadu.html Fri, 15 May 2026 12:53:51 +0530 The rise of actor-turned-politician C. Joseph Vijay, popularly known as Thalapathy Vijay, as the Chief Minister (CM) of Tamil Nadu marks a major political transition in the state’s governance. After leading Tamilaga Vettri Kazhagam (TVK) to electoral success in the 2026 Assembly elections, Vijay assumed office with a strong emphasis on law and order, youth welfare, and social reform. Among the first decisions of his administration, the crackdown on narcotics and synthetic drug circulation has emerged as one of the government’s most urgent priorities. Immediately after taking oath at Chennai’s Jawaharlal Nehru Indoor Stadium, Chief Minister Vijay on May 10 signed three major policy files that reflected his government’s immediate priorities. These included the rollout of 200 units of free electricity for domestic consumers, the creation of the “Singappen” special rapid response police force for women’s safety, and the launch of a major “Drug Free Tamil Nadu” initiative through the formation of dedicated Anti-Narcotics Task Force units across all districts. The inclusion of the anti-drug mission among his very first executive decisions highlighted Vijay’s determination to make Tamil Nadu a drug-free state. The move signalled that the new administration views the drug menace not merely as a policing issue, but as a social emergency threatening the future of Tamil Nadu’s youth. A Growing Drug Crisis in Tamil Nadu Tamil Nadu has witnessed a sharp rise in narcotics-related crimes over the last few years. Official enforcement data reveal that NDPS cases in the state increased dramatically from 1,252 cases in 2020 to 2,590 cases in 2022, while arrests crossed 10,000 during the same period. Although cannabis continues to dominate seizures in terms of quantity, authorities are increasingly alarmed by the rapid growth of synthetic and designer drugs. The most worrying trend is the explosion in synthetic drug circulation. LSD, which stands for Lysergic Acid Diethylamide, is a powerful synthetic hallucinogenic drug that alters perception, mood, and sensory experiences. Commonly sold in the form of blotter papers or “acid tabs,” LSD has emerged as a major concern among enforcement agencies because of its growing popularity among college students and urban youth. LSD was originally synthesized in 1938 by Swiss chemist Albert Hofmann and is known for causing hallucinations, distorted thinking, panic attacks, and severe psychological effects. In India, LSD is classified as an illegal narcotic substance under the Narcotic Drugs and Psychotropic Substances (NDPS) Act. Tamil Nadu authorities have reported a dramatic increase in LSD seizures in recent years. LSD blot seizures rose from just 99 blots in 2021 to nearly 3,905 blots in 2024, signalling the rapid spread of synthetic narcotics in urban networks. Investigations by enforcement agencies have also uncovered clandestine laboratories involved in manufacturing methamphetamine, ketamine, and LSD using imported chemical precursors such as pseudoephedrine and ephedrine. Unlike traditional narcotics, synthetic drugs pose a more dangerous challenge because they are easier to manufacture, highly addictive, and difficult to detect. They are increasingly penetrating urban college campuses, nightlife circuits, and even school environments. Law enforcement officials believe Tamil Nadu’s strong transport connectivity, ports, and urban consumer market have made the state vulnerable to interstate and international trafficking networks. New Government’s 7-Point Anti-Drug Framework Recognizing the seriousness of the threat, the Vijay-led government introduced a comprehensive 7-point Anti-Drug Action Plan aimed at dismantling narcotics networks and reducing drug consumption among youth. The government’s strategy includes: Continuous surveillance of drug offenders and organized syndicates Monitoring of encrypted digital platforms used for drug transactions Intelligence-driven raids and targeted enforcement operations Interstate and inter-district narcotics tracking Strict enforcement of the NDPS Act Rehabilitation and counselling support for addicts Large-scale awareness campaigns in schools and colleges At the heart of this initiative is the appointment and deployment of a massive Anti-Narcotic Task Force structure across Tamil Nadu. The government has ordered the establishment of 65 specialized Anti-Narcotic Task Force units across police districts and commissionerates. Senior police officials, inspectors, sub-inspectors, and head constables are being specifically assigned to these dedicated units to strengthen intelligence gathering, surveillance, and field enforcement against narcotics networks. These task forces are expected to function as rapid-response enforcement teams focused on identifying traffickers, dismantling synthetic drug supply chains, and preventing the spread of narcotics among youth. These units are expected to function as rapid intelligence and enforcement teams dedicated specifically to narcotics control. The Chief Minister has also ordered direct monitoring of anti-drug operations through the Home Department, reflecting the administration’s intention to maintain political oversight over enforcement activities. Special Focus on Synthetic Drugs A defining feature of the new government’s policy is its explicit focus on synthetic drug consumption. Previous anti-drug drives in Tamil Nadu largely concentrated on cannabis and alcohol abuse. However, the Vijay administration has acknowledged that the future threat lies in chemically manufactured narcotics such as methamphetamine, MDMA, LSD, ketamine, and pharmaceutical opioid misuse. Synthetic drugs are particularly dangerous because they target younger demographics and spread rapidly through social media influence, online dealers, rave culture, and peer networks. Enforcement agencies have found that many transactions now occur through encrypted apps and digital payment systems, making conventional policing inadequate. The government’s strategy therefore combines cyber surveillance with intelligence-based enforcement. Special teams are expected to monitor online trafficking channels, darknet marketplaces, and courier networks suspected of transporting synthetic substances. Authorities are also planning stronger coordination with central agencies such as the Narcotics Control Bureau and interstate police units to intercept precursor chemicals entering Tamil Nadu through ports and logistics chains. Multi-Department “Drug Free Tamil Nadu” Mission The anti-drug campaign is not limited to policing alone. The state government has launched a broader “Drug Free Tamil Nadu” mission involving 11 government departments, including Health, School Education, Higher Education, Social Welfare, Youth Welfare, Rural Development, and Information & Public Relations. This multi-sectoral approach recognizes that addiction is both a law-and-order issue and a public health challenge. The Education Department has become a central pillar of the campaign. One of the most significant preventive initiatives under the “Drug Free Tamil Nadu” mission is the establishment of Anti-Drug Clubs in schools, colleges, and technical institutions across the state. These clubs are designed to function as student-led awareness and prevention platforms aimed at identifying early signs of substance abuse and promoting a culture of drug-free campuses. The Anti-Drug Clubs will organize awareness campaigns, counselling sessions, seminars, street plays, social media outreach, and peer-support activities focusing especially on synthetic drugs such as LSD, methamphetamine, MDMA, and pharmaceutical substance abuse. Teachers, NSS volunteers, student coordinators, and trained counsellors are expected to work together in identifying vulnerable students and encouraging early intervention. The state government has also planned district-level and state-level training programs for Anti-Drug Club coordinators and volunteers. Master trainers are being appointed across School Education, Higher Education, and Technical Education departments to standardize awareness modules and prevention strategies. Officials believe these clubs are important because synthetic drug consumption is increasingly spreading among teenagers and college students through peer pressure, nightlife culture, social media influence, and online trafficking networks. The clubs are therefore expected to act not only as awareness centres but also as community surveillance and youth engagement platforms. To encourage participation, the government is considering recognition and awards for institutions that actively implement anti-drug activities and demonstrate effective prevention outcomes. Authorities hope that sustained student involvement will help create a long-term social movement against narcotics in Tamil Nadu. The government believes educational institutions are critical battlegrounds in preventing synthetic drug addiction among adolescents and young adults. In 2025-26, the Tamil Nadu Finance Department allocated approximately Rs 1.5 crore specifically for training anti-drug volunteers, master trainers, and awareness coordinators under the initiative. Training modules are being prepared for schools, colleges, technical institutions, and women’s self-help groups. The government’s emphasis on awareness reflects growing concerns that academic pressure, unemployment, urban stress, and peer influence are pushing vulnerable youth toward substance abuse. Public Health and Rehabilitation Measures While the Vijay government has adopted a tough enforcement stance, it has also acknowledged the need for rehabilitation and treatment. Tamil Nadu already operates limited de-addiction and opioid substitution therapy (OST) programs through health institutions and NGOs. However, experts argue that rehabilitation infrastructure remains insufficient compared to the scale of addiction. The government is therefore expected to expand counselling centres, mental health support systems, and rehabilitation programs, especially for students and first-time users. Public health officials are advocating for stronger integration between hospitals, schools, social welfare agencies, and law enforcement authorities. Experts warn that punitive policing alone cannot solve the synthetic drug crisis. Long-term success will depend on reducing demand through awareness, counselling, family support systems, and youth engagement programs. Challenges Ahead Despite the ambitious framework, the government faces several challenges. First, Tamil Nadu lacks a comprehensive state-wide survey on illicit drug consumption, making it difficult to accurately measure the scale of addiction. Current data are largely based on seizures and arrests, which reflect enforcement activity rather than actual prevalence. Second, synthetic drug trafficking networks are highly adaptive and technologically sophisticated. Darknet sales, encrypted messaging apps, and interstate courier systems create enforcement difficulties that require specialized cyber capabilities. Third, rehabilitation capacity remains limited, especially in rural districts. Without sufficient treatment infrastructure, many addicts risk returning to substance abuse even after police intervention. Finally, experts stress that social and economic factors such as unemployment, migration stress, educational pressure, and social isolation continue to fuel drug dependency among youth. A Political and Social Test For Chief Minister Vijay, the anti-drug campaign represents more than a governance initiative — it is a defining political test of his leadership. His administration has framed the issue as a battle to protect Tamil Nadu’s younger generation from a growing synthetic drug epidemic. The success of the “Drug Free Tamil Nadu” mission will depend on whether the government can sustain coordination between police, health departments, educational institutions, and local communities over the long term. If effectively implemented, the campaign could become one of the most significant public health and law-enforcement reforms undertaken in Tamil Nadu in recent years. But if gaps in enforcement, rehabilitation, and data collection persist, the synthetic drug crisis may continue evolving faster than the state’s response mechanisms. The coming years will determine whether Vijay’s government can transform its strong political messaging into a durable and evidence-based anti-drug model for the state.   Narayan Kulkarni narayan.kulkarni@mmactiv.com ]]> https://biospectrumindia.com/news/22/27793/icmr-transfers-three-indigenous-medical-technologies-to-industry.html https://biospectrumindia.com/news/22/27793/icmr-transfers-three-indigenous-medical-technologies-to-industry.html Mon, 11 May 2026 22:15:39 +0530 Indian Council of Medical Research (ICMR) participated in a special programme on the occasion of National Technology Day 2026, organised by BRIC- National Institute of Immunology (NII), New Delhi. The event was graced by the presence of Minister of State (Independent Charge) for Science and Technology, Dr Jitendra Singh; Prof. Ajay Kumar Sood, Office of the Principal Scientific Adviser (PSA); Dr Rajiv Bahl, Secretary, Ministry of Health and Family Welfare and Director General, ICMR, and other dignitaries. As part of its demonstration programme, ICMR showcased six high-impact indigenous technologies spanning the bio-pharma, health and bio-industrial and green chemical sectors. These included Covaxin, COVID Kavach ELISA kit, CRISPR-Cas based TB detection system, Nipah point-of-care assay, a diagnostic ELISA kit for dengue detection and a biolarvicide for mosquito control . In addition, an official compilation was released during the event that contains 25 new products developed by various ICMR institutes. A major attraction of the event was the transfer of three innovative technologies developed by ICMR, to industry partners. The first technique, titled 'Development of affordable PSP 94 ELISA for guiding biopsy decisions in patients with PSA less than 20 ng/ml', developed by National Institute for Research in Women's Health. The technology was licensed to KrishGen Labs. The second technology transfer included 'Factor VIII Inhibitors/ Coagulation Disorder Point-of-Care Diagnostic' developed by National Institute for Research on Blood and Immune Disorders (ICMR-NIRBID). The technology was licensed to Merrill Life Sciences. The third technique 'Single-tube multiplex real-time RT-PCR to detect dengue, chikungunya and Zika viruses', developed by National Institute of Virology, was licensed to Vanguard Life Sciences.   ]]> https://biospectrumindia.com/news/22/27782/health-ministry-launches-integrated-training-programme-to-strengthen-frontline-healthcare-services.html https://biospectrumindia.com/news/22/27782/health-ministry-launches-integrated-training-programme-to-strengthen-frontline-healthcare-services.html Fri, 08 May 2026 17:11:20 +0530 Reinforcing commitment to comprehensive primary healthcare care and strengthening capacities of frontline healthcare providers, Union Minister for Health and Family Welfare Jagat Prakash Nadda addressed Integrated Primary Health Care Teams during the 10th National Health Summit on "Innovation and Inclusivity: Best Practices Shaping India's Health Future" and launched the training programme. This integrated training marks a decisive shift for primary healthcare teams from capacity development to a single, structured, and competency-based framework. This will enable the country's frontline healthcare workers to become confident providers providing comprehensive, people-centric care to the last mile. The integrated training for primary healthcare teams is a crucial step towards strengthening this foundation. By integrating various programme-based trainings into a single, structured, and competency-oriented framework, this initiative simplifies the learning process while enhancing the capabilities of frontline healthcare providers. This enables them to provide comprehensive care, from prevention and early detection to treatment and follow-up care, ensuring that people receive the right care at the right time, close to their homes. Digital platforms like iGOT Karmayogi will future-ready the continuous learning process by making it workforce-friendly, in line with the country's technological advancements. ]]> https://biospectrumindia.com/news/22/27766/health-ministry-launches-janani-platform-for-maternal-and-child-health-services.html https://biospectrumindia.com/news/22/27766/health-ministry-launches-janani-platform-for-maternal-and-child-health-services.html Thu, 07 May 2026 14:44:34 +0530 In a significant step towards strengthening maternal and child health services in the country, the Ministry of Health and Family Welfare launched the JANANI (Journey to Prenatal, Postnatal and Neonatal Integrated Care) platform at the recently concluded National Innovation and Inclusivity Summit – Best Practices Shaping India's Health Future. Janani is a service-focused digital platform designed for comprehensive monitoring and maintenance of digital health records of women of reproductive age. The platform, developed as an upgraded version of the existing RCH portal, creates a long-term health record by recording key service delivery interventions in the continuum of care. The platform aims to ensure smooth monitoring of maternal and child health services, including antenatal care, pregnancies for delivery, delivery, postnatal care, newborn care, home-based newborn and child care, and family planning. By enabling continuous monitoring and timely intervention, Janani strengthens service delivery and ensures continuity of care at every stage. One of the key features of Janani is the introduction of QR-coded digital Maternal and Child Health (MCH) cards, which enable easy access and portability of health records. The platform also includes features such as automated alerts for high-risk pregnancies, real-time dashboards for supervisory reviews, and fixed-list creation, enabling timely tracking, monitoring, and targeted interventions. ]]> https://biospectrumindia.com/news/22/27767/niscpr-signs-mou-with-ris-to-strengthen-science-technology-innovation-policy-and-diplomacy.html https://biospectrumindia.com/news/22/27767/niscpr-signs-mou-with-ris-to-strengthen-science-technology-innovation-policy-and-diplomacy.html Thu, 07 May 2026 14:52:41 +0530 To strengthen cooperation in the fields of science, technology, innovation, policy, and diplomacy, the National Institute of Science Communication and Policy Research (NIScPR) has signed a Memorandum of Understanding (MoU) with the Research and Information System for Developing Countries (RIS). This collaboration will be carried out through joint research, policy analysis, capacity building, and knowledge sharing. The partnership will promote work in the fields of science policy, communication, diplomacy, and traditional knowledge, as well as conduct joint projects, publications, policy dialogues, workshops, and outreach activities for inclusive and sustainable development. Prof. Sachin Kumar Sharma, Director General, RIS, described science diplomacy as an important tool to build trust and address global challenges such as climate change, health and technology inequalities. He also stressed on the role of developing countries in shaping scientific governance. He outlined the initiatives of RIS including ITEC course, iGOT Karmayogi training, publication of Indian Science Diplomacy Forum and Global Partnership through South and IBSA Fellowship. Dr Geetha Vani Rayasam, Director, CSIR-NIScPR described this partnership as a collaborative and mutually beneficial effort for developing countries, focusing on working groups and joint publications. ]]> https://biospectrumindia.com/news/22/27768/office-of-principal-scientific-adviser-joins-hands-with-ficci-to-create-conducive-rd-environment-.html https://biospectrumindia.com/news/22/27768/office-of-principal-scientific-adviser-joins-hands-with-ficci-to-create-conducive-rd-environment-.html Thu, 07 May 2026 14:59:52 +0530 The Office of the Principal Scientific Adviser to the Government of India has signed a Memorandum of Understanding (MoU) with the Federation of Indian Chambers of Commerce and Industry (FICCI). The MoU establishes a broad cooperative framework across five key areas: Industry–Academia Collaboration; Problem Identification and Solution Development; Global Collaboration; Policy Dialogue and Advisory Support; and Capacity Building and Knowledge Sharing. To operationalise this partnership, the parties may establish a Joint Coordination Mechanism and conduct six-monthly reviews to assess progress and impact. The partnership addresses a critical gap in India's innovation landscape. While India ranks highly in scientific research output and academic patent filings, it continues to lag in technology commercialisation and industry–academia collaboration. India's Gross Expenditure on R&D (GERD) as a percentage of GDP remains at approximately 0.6–0.7%, significantly below global innovation leaders such as South Korea (5.21%), the United States (3.59%), and China (2.56%). Moreover, the private sector's contribution to R&D funding in India accounts for only around 36%, compared to over 70% in these nations. Among the key priorities identified under this partnership are: facilitating structured collaborations between industry, academic institutions, and research organisations; accelerating the commercialisation of research with clear pathways for pilot deployment and scale-up; co-creating problem statements of national importance to drive demand-led innovation; and supporting the effective utilisation of the Government of India's Rs 1 Lakh Crore Research, Development and Innovation (RDI) Fund through industry-specific awareness initiatives and last-mile handholding support.   ]]> https://biospectrumindia.com/news/22/27759/third-meeting-of-india-japan-joint-committee-strengthens-cooperation-in-healthcare.html https://biospectrumindia.com/news/22/27759/third-meeting-of-india-japan-joint-committee-strengthens-cooperation-in-healthcare.html Tue, 05 May 2026 19:16:30 +0530 The third meeting of the Joint Committee on Health (JCM) between India and Japan was held at Bharat Mandapam on 5 May. Jagat Prakash Nadda, Union Minister of Health and Family Welfare and Kimi Onoda, Minister in charge of Health Policy, Japan, jointly chaired the meeting. Nadda said that India-Japan cooperation in the field of healthcare is guided by the Memorandum of Cooperation on Health and Wellness and the shared vision of strengthening health systems, improving access to healthcare services, and promoting innovation for better outcomes in the healthcare sector. The Japanese delegates highlighted the ongoing initiatives for cooperation, including projects focused on strengthening treatment systems through screening for cancer detection, early detection and technical cooperation, and institutional capacity building. The Japanese delegates also elaborated on their model of coordinated public-private cooperation aimed at increasing access to medical products and services, building robust supply chains, and facilitating the deployment of technology through streamlined partnerships. In his concluding remarks, Nadda said that the deliberations have given new momentum to the India-Japan Health Partnership. They reaffirmed their shared commitment to further strengthen cooperation in key priority areas. He emphasised that the discussions have set a clear direction for strengthening resilient and inclusive healthcare systems.   ]]> https://biospectrumindia.com/news/22/27757/health-ministry-unveils-comprehensive-guidance-document-on-diabetes-mellitus-in-children.html https://biospectrumindia.com/news/22/27757/health-ministry-unveils-comprehensive-guidance-document-on-diabetes-mellitus-in-children.html Mon, 04 May 2026 22:33:22 +0530 In a historic step towards strengthening child health services, the Ministry of Health and Family Welfare has released the guidance document on Diabetes Mellitus in children. Through this guidance document, for the first time, a structured and standardised national framework for screening, diagnosis, treatment, and long-term management of paediatric diabetes has been established. With this initiative, India has joined the select group of countries that have integrated paediatric diabetes care into the public health system. The document aims to ensure universal screening of all children from birth to 18 years, including early detection through community and school-based platforms. Suspected cases will be subjected to immediate blood sugar tests, followed by confirmatory referrals to district-level health centres for diagnosis and treatment. A key feature of the scheme is the provision of comprehensive, free care packages at public health facilities. This includes screening, diagnostic services, lifelong insulin therapy, monitoring equipment such as glucometers and test strips, and regular follow-up care. This approach aims to alleviate the financial burden and ensure seamless treatment for children with diabetes. The Guidance Document also mentions an integrated chain of care, linking community level screening with district hospital-based management and advanced care in medical colleges. ]]> https://biospectrumindia.com/news/22/27725/dpiit-releases-operational-guidelines-for-startup-india-fund-of-funds-2-0-of-rs-10000-cr.html https://biospectrumindia.com/news/22/27725/dpiit-releases-operational-guidelines-for-startup-india-fund-of-funds-2-0-of-rs-10000-cr.html Sun, 26 Apr 2026 00:00:00 +0530 The Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, has released the operational guidelines for the Startup India Fund of Funds 2.0 (FoF 2.0). These guidelines provide a structured framework for operationalising the Rs 10,000 crore fund, including clearly defined mechanisms for the utilisation, operation, and monitoring of the fund. It aims to improve the efficiency of capital flows into India's startup ecosystem. The scheme will be implemented through commitments to Alternative Investment Funds (AIFs) of Categories I and II registered with SEBI, which will invest in startups accredited by DPIIT. Doing so is expected to bring discipline in capital allocation, attract private investments, and ensure wider access to financing across multiple sectors, stages, and geographies. Small Industries Development Bank of India (SIDBI) will act as the initial implementing agency and implement through a streamlined AIF selection and monitoring process. DPIIT will also engage additional implementing agency to enhance outreach, improve sectoral expertise and build institutional capacities to manage such schemes. To address the specific gaps in the ecosystem, the Operational Guidelines structurally categorise AIFs (Alternative Capital Investments) to include intensive technology-focused funds, micro venture capital funds supporting early-growth startups, funds focused on innovative and technology-based manufacturing sectors, and sector and phase-related funds. There are criteria set for each segment, including fund limits, government contribution limits, tenure, and minimum private capital raising ratio, ensuring that capital is directed to priority sectors while maintaining market discipline. The guidelines prescribe a two-stage selection process for AIFs. The implementing agency will conduct preliminary investigations, which will be followed by an evaluation by the Venture Capital Investment Committee. The committee will assess the proposals based on the team's track record, fund management capacity, and investment strategy. The committee comprises eminent leaders from industry, academia, and the innovation ecosystem. Startup India FOF 2.0 has been developed to act as a catalyst rather than a direct investor, enabling multiplier effect through private capital participation. The guidelines mandate minimum private capital mobilisation, thereby strengthening the market-based investment discipline. ]]> https://biospectrumindia.com/news/22/27718/indian-pharmacopoeia-commission-inks-new-partnerships-to-boost-drug-quality-and-research.html https://biospectrumindia.com/news/22/27718/indian-pharmacopoeia-commission-inks-new-partnerships-to-boost-drug-quality-and-research.html Fri, 24 Apr 2026 00:00:00 +0530 The Indian Pharmacopoeia Commission (IPC), under the Ministry of Health and Family Welfare, Government of India, has signed Memorandums of Understanding (MoUs) with the Bureau of Pharmaceuticals and Medical Devices Bureau of India (PMBI), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India and the National Institute of Pharmaceutical Education and Research (NIPER), Hajipur, Bihar, an autonomous institution under the Ministry of Chemicals and Fertilizers, Government of India. The MoU between the Pharmacopoeia Commission of India and the Pharmaceuticals and Medical Devices Bureau of India aims to strengthen the quality assurance framework for medicines made available through Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJKs). Under this collaboration, PMBI can submit randomly selected batches of Jan Aushadhi medicines to IPC for quality testing. This partnership will promote the use of India's National Formulary (NFI) in PMBJKs to ensure rational use of medicines. It also aims to strengthen pharmacovigilance activities by displaying the QR code of the Pharmacovigilance Programme of India (PVPI) and toll-free helpline number (1800-180-3024) at PMBJKs across the country, thereby encouraging reporting of adverse drug reactions (ADRs) and improving patient safety. Additionally, IPC and PMBI will jointly organise sensitization, awareness and training programmes for pharmacists and stakeholders on rational use of drugs, pharmacovigilance, ADR reporting tools, and the role of pharmacists in safeguarding public health. The MoU signed between the Pharmacopoeia Commission of India and NIPER, Hajipur focuses on collaborative research, academic exchanges, and capacity building in the field of pharmaceutical science and healthcare products. NIPER Hajipur, an Institute of National Importance, possesses advanced expertise in pharmaceutical analysis, biologics, and clinical research, making it a valuable partner in strengthening pharmacopoeial science and patient safety. The collaboration will include joint research programmes on profiling impurities, including genotoxic impurities such as nitrosamine and their correlation with adverse drug response data, to establish evidence-based pharmacopoeial boundaries. It will also focus on the development of analytical methods, quality control protocols, and reference standards for biologics, biosimilars, and emerging cell and gene therapy products, so that they can be incorporated into the Indian Pharmacopoeia. The two institutes will collaborate in organising training programs, workshops, seminars, and conferences, as well as faculty exchange initiatives and sharing of advanced analytical instrument facilities. Internship and fellowship opportunities for pharmacy graduates and postgraduates, as well as joint publication of research papers, training manuals, and educational materials, will further strengthen scientific engagement and institutional capacity building. ]]> https://biospectrumindia.com/news/22/27614/st-minister-pitches-for-scaling-up-indigenous-insulin-production.html https://biospectrumindia.com/news/22/27614/st-minister-pitches-for-scaling-up-indigenous-insulin-production.html Mon, 06 Apr 2026 00:00:00 +0530 The President-elect of the "International Diabetes Federation" (IDF) Dr Niti Pal, recently met Union Minister of Science Technology (S&T) Dr Jitendra Singh, who is also a renowned professor of medicine and diabetes. The meeting underscored the importance of strengthening India's capabilities in insulin manufacturing, particularly in terms of biosimilar insulin and continuous glucose monitoring (CGM) devices. The discussion focused on the growing global concerns over the future availability of insulin. The Minister noted that globally, insulin production is currently concentrated among a limited number of companies, making supply chains unsafe and affordability remains a constant challenge, especially for type 1 diabetics who are dependent on lifelong insulin therapy. Dr Pal noted the rapid expansion of low-cost equipment from countries such as China, which offers a significant price advantage over Western products, and warned that these manufacturers are already gaining substantial market share. Dr Jitendra Singh observed that Indian companies have the technical capacity to develop comparable equipment, including CGM, and scaling up production from them will require strong industry participation and targeted support. He pointed out that efforts are underway to develop affordable monitoring technologies in the domestic ecosystem. Both sides discussed possibilities for deeper collaboration between Indian researchers, industry stakeholders and international partners, such as in the areas of clinical trials, technology development and financing models, etc. Dr Jitendra Singh suggested that during Dr Pal's proposed next visit to India, a stakeholder meeting is expected to be convened in July to bring together stakeholders and explore avenues for scaling up manufacturing and global reach.   ]]> https://biospectrumindia.com/news/22/27612/indiaai-and-cdsco-launch-health-innovation-acceleration-hackathon.html https://biospectrumindia.com/news/22/27612/indiaai-and-cdsco-launch-health-innovation-acceleration-hackathon.html Thu, 02 Apr 2026 00:00:00 +0530 India AI in collaboration with Central Drugs Standard Control Organisation (CDSCO) has launched CDSCO-India AI Health Innovation Acceleration Hackathon. India AI is the independent business division (IBD) of Digital India Corporation (DIC) under the Ministry of Electronics and Information Technology (MeitY). This initiative comes under the India AI Application Development Initiative (IADI). It aims to promote the development and adoption of AI applications in critical sectors. This hackathon invites participants to create comprehensive, end-to-end AI solutions in two phases, so that the regulator workflows can be streamlined. In the first phase, applicants will be expected to develop robust data anonymisation tools. Additionally, the solution should feature intelligent document summarisation. Under the second phase, the selected teams will have to further fine-tune their models using CDSCO's specialised datasets, and SUGAM and MD Online Integration with portals has to be enabled. It aims to speed up the process of regulatory approvals and improve access to healthcare innovations. This phase will conclude with the Detailed Project Report based on the outcomes . The hackathon involves a multi-stage evaluation process. Top 10 teams from the first phase to be held at CDSCO office, New Delhi for a special 5-day on-premises (at office premises) Development will move forward in the phase. The winning team will receive an amount of up to Rs 10 lakh, plus one of up to Rs 50 lakh for developing, integrating, and implementing the solution. There will also be an opportunity to get the work contract of the year. Other prizes include up to Rs 7 lakh for the second prize and up to Rs 3 lakh for the third prize. In addition, a special award of up to Rs 5 lakh will be given to the all-women team. ]]> https://biospectrumindia.com/news/22/27584/dialogues-at-pharmamed-2026-lay-out-roadmap-for-indias-pharma-future.html https://biospectrumindia.com/news/22/27584/dialogues-at-pharmamed-2026-lay-out-roadmap-for-indias-pharma-future.html Sat, 28 Mar 2026 00:00:00 +0530 The 9th edition of PharmaMed 2026 was organised by PHD Chamber of Commerce and Industry (PHDCCI) in collaboration with Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India in New Delhi on 27 March. Focused on the theme "Healthcare Equity: Reaching Every Citizen of Viksit Bharat", the inaugural session was attended by senior policy makers, global regulators, industry leaders and experts, setting the stage for a meaningful dialogue on strengthening the country's pharmaceutical sector. The inaugural session focused on strengthening supply chain resilience, promoting self-reliance in APIs and Key Starting Materials (KSMs). The focus was on key issues including promotion and furthering public-private partnerships. The session on 'Redefining India's Pharmaceutical Leadership – From Quantity to Value' was attended by representatives from CDSCO, PharmaExil, Cipla and NIPER. The main objective of this session was to propel India's pharmaceutical sector towards high-value innovation. The discussions focused on strengthening research in the field of biologics, advanced therapeutics, and biosimilars. In the session on 'Strengthening Pharmaceutical Quality – Regulatory Harmonization and Global Compliance', the delegates emphasized on improving quality standards across the supply chain through robust regulatory frameworks and compliance.  Central Drugs Standard Control Organization (CDSCO), Pharmexcil, Cipla, AstraZeneca, Indian Pharmaceutical Producers' Organization, Serum Institute of India, Biotechnology Industry Research Assistance Council (BIRAC), National Institute of Pharmaceutical Education and Research (NIPER) Mohali, United States Food and Drug Administration (USFDA), Tenet Health Edutech Pvt Ltd, NuLifeCare, Daund Biological, EVERSANA, Jamia Hamdard, Mankind Pharma, Apollo Pharmacy, Tata 1mg, and key organisations and industry stakeholders such as the Association of Healthcare Providers India actively participated in these sessions, contributing their diverse expertise and valuable insights through the sessions. ]]> https://biospectrumindia.com/news/22/27554/ministry-of-ayush-and-dbt-announce-joint-clinical-study-for-treatment-of-tb-with-ayurveda.html https://biospectrumindia.com/news/22/27554/ministry-of-ayush-and-dbt-announce-joint-clinical-study-for-treatment-of-tb-with-ayurveda.html Wed, 25 Mar 2026 00:00:00 +0530 Ministry of Ayush has launched a collaborative study titled “Clinical Study on Ayurveda as an Adjunct Therapy for Tuberculosis” in partnership with the Department of Biotechnology (DBT). The joint announcement was made by Dr Jitendra Singh, Minister of State (Independent Charge), Ministry of Science and Technology and Prataprao Jadhav, Minister of State (Independent Charge) of the Ministry of Ayush and Minister of State in the Ministry of Health & Family Welfare in the presence of senior officials and scientists of the Ministries.  Prof. Vaidya Rabinarayan Acharya, Director General of the Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, Government of India and BRIC- Director of the National Institute of Immunology (NII), Dr Debasisa Mohanty presented a brief overview of the collaborative clinical study.  The presentation detailed the scientific design, objectives, and expected outcomes of the study, which aims to evaluate the efficacy, safety, and tolerability of an Ayurveda regimen as an adjunct to standard anti-tuberculosis treatment (ATT), along with macronutrient supplementation. To be conducted across premier institutions including AIIMS, JIPMER, and NEIGRIHMS, the 24-month study aims to generate robust scientific evidence on improving nutritional outcomes, accelerating recovery, and enhancing quality of life among TB patients, further strengthening India’s commitment to innovative, patient-centric approaches for TB elimination. A key highlight of the event was the exchange of a Memorandum of Understanding (MoU) between BRIC-Translational Health Science and Technology Institute (THSTI) and CCRAS, formalising institutional collaboration. ]]> https://biospectrumindia.com/news/22/27555/health-minister-launches-100-day-tb-mukt-bharat-abhiyaan.html https://biospectrumindia.com/news/22/27555/health-minister-launches-100-day-tb-mukt-bharat-abhiyaan.html Wed, 25 Mar 2026 00:00:00 +0530 Union Minister for Health and Family Welfare Jagat Prakash Nadda participated in a national-level event organised in Greater Noida on the occasion of World Tuberculosis Day 2026. He reiterated the country's firm and unwavering commitment to make India TB free even before the deadline for the Global Sustainable Development Goals. The event highlighted India's sustained and multifaceted efforts to fight the comprehensive fight against TB through a robust public health system, increased community participation, and innovation and technology-based solutions. World TB Day, observed on March 24 every year, is a global call to accelerate efforts to eradicate one of the world's deadliest infectious diseases—tuberculosis (TB). The Union Health Minister launched a focused and intensive 'TB Mukt Bharat' campaign. The campaign is a decisive and mission-mode effort to accelerate progress towards TB elimination. 1.58 lakh villages and urban wards will be covered under this campaign. For each of these locations, micro-plans will be made as per local needs so that the campaign can be implemented with precision and its outcomes can also be clearly measured. With a special focus on vulnerable populations such as the urban poor, tribal communities, and migrant groups, this initiative aims to address barriers to last mile access, early detection of TB, and ensure equitable access to TB services. This will significantly strengthen India's fight against TB at the grassroots level. In the digital realm, the Union Minister launched the 'TB Mukt Bharat' app, which includes an Artificial Intelligence-enabled, multilingual chatbot named "Khushi". It is designed in such a way that it can be easily used even on entry-level smartphones. The platform provides real-time information about symptoms, facilities available, and nearby testing centres, helping to bridge the critical gap between the onset of symptoms and timely initiation of treatment. Nadda also flagged off 'Ni-kshay Vahan'. The aim is to improve access to the last mile and improve access to TB screening and treatment services, especially in areas where these services are lacking.  ]]> https://biospectrumindia.com/news/22/27556/regulatory-oversight-on-supply-chain-of-weight-loss-drugs-glp-1.html https://biospectrumindia.com/news/22/27556/regulatory-oversight-on-supply-chain-of-weight-loss-drugs-glp-1.html Wed, 25 Mar 2026 00:00:00 +0530 The Drugs Controller of India (DCGI) has intensified its regulatory oversight against unauthorised sale and promotion of the drug to ensure ethical pharmacological procedures in the supply chain of the weight loss drug (GLP-1). The introduction of several novel generic variants of GLP-1 based weight loss drugs in the Indian market has raised concerns about their on-demand availability through retail pharmacies, online platforms, wholesalers and health clinics. The use of these medications without proper medical supervision can lead to serious side effects and associated health risks. Taking cognizance of the situation, the Drugs Controller General of India in collaboration with the State Regulators has initiated action to curb and curb potential malpractices in the drug supply chain and prevent unauthorized sale and use. Recently, a comprehensive advisory was issued to all manufacturers, prohibiting clearly misleading advertisements and any form of indirect promotion that could mislead consumers or encourage off-label use. At present, enforcement activities have been significantly enhanced. Audits and inspections were carried out in 49 entities including online pharmacy warehouses, pharmaceutical wholesalers, retailers, health and weight loss clinics . These inspections were conducted in multiple areas across the country and aimed to identify violations related to unauthorised sales, improper prescription methods, and deceptive marketing. In addition, notices have also been sent to the delinquent entities. The regulator emphasises that the safety of patients is paramount. Misuse of weight loss medications without medical supervision can lead to serious health problems. Citizens are advised to use such medicines only under the guidance of qualified medical practitioners.   ]]> https://biospectrumindia.com/news/22/27521/government-sets-up-national-dental-commission.html https://biospectrumindia.com/news/22/27521/government-sets-up-national-dental-commission.html Sat, 21 Mar 2026 00:00:00 +0530 In a significant reform aimed at improving the quality of dental education and bringing it at par with global standards, the Government of India has replaced the Dental Council of India (DCI) with the National Dental Commission (NDC) and three autonomous boards. Notifications in this regard were issued on 19th March 2026 and the composition of NDC came into effect from that date. This landmark reform marks a decisive shift towards a transparent, quality-focused, and accountable regulatory framework, replacing the preceding elected structure. The Commission will implement necessary and long-awaited regulatory reforms in dental education and increase access to affordable oral health care throughout the country. Eminent professionals have been appointed to lead the Commission and its Boards. Three autonomous bodies have been constituted to support the functioning of the Commission: Undergraduate and Post Graduate Dental Education Board – to oversee dental education Dental Evaluation and Rating Board – to regulate accreditation and institutional assessment Dental Ethics and Registration Board to regulate the professional conduct and registration of dentists The following appointments have been approved in the National Dental Commission and its Autonomous Boards: National Dental Commission Dr Sanjay Tiwari – President Dr Moushumi Goswami – Part-time Member Board of Undergraduate and Postgraduate Dental Education Dr Chandrashekhar Janakiram – President Dr Shailesh Madhav Lele - Whole Time Member Dr Nagaraj M. - Part-time Member Dental Assessment and Rating Board Lt Gen (Retd) Nanda Kishore Sahu – Chairman Dr Himanshu Aran - Whole-time Member Dr Parimala Tyagi - Part-time Member Ethics & Dental Registration Board Lt Gen (Retd) Tapas Kumar Bandyopadhyay – Full time Member Dr Usha Hegde – Whole-time Member Dr Swarg Jyoti Das - Part-time Member Arindam Modak will head the Secretariat as Secretary of NDC.   The National Dental Commission will perform the following functions: To make rules to implement the provisions of the Act Will evaluate and rate dental institutions Evaluate human resources and promote dental research Guidelines for fee regulation in private dental colleges to be formulated Establish standards for community dental care, education, research, and professional ethics With the coming into force of the NDC Act from March 19, 2026, the Dentists Act, 1948 was repealed and the Dental Council of India was dissolved from the same date. ]]> https://biospectrumindia.com/news/22/27497/astrazeneca-pharma-receives-cdsco-approval-for-oncology-drug-durvalumab.html https://biospectrumindia.com/news/22/27497/astrazeneca-pharma-receives-cdsco-approval-for-oncology-drug-durvalumab.html Tue, 17 Mar 2026 00:00:00 +0530 AstraZeneca Pharma India has announced that Central Drugs Standard Control Organisation (CDSCO) has approved an additional indication for Durvalumab solution for infusion (120 mg/2.4 mL and 500 mg/10 mL), for the treatment of patients with unresectable hepatocellular carcinoma (uHCC),who have not received prior systemic therapy. Worldwide, hepatocellular carcinoma (HCC) is the sixth most common cancer and the third leading cause of cancer death. In India, according to GLOBOCAN 2022, more than 38,000 new cases of HCC are diagnosed annually, making it the 11th most common cancer. HCC’s high mortality rate makes it the 8th leading cause of cancer-related deaths in the country, underscoring the urgent need for effective treatment options. Durvalumab in combination with single dose of tremelimumab (STRIDE) has been approved in patients with uHCC based on the HIMALAYA global Phase III trial, where the STRIDE regimen showed superior outcomes over sorafenib. While immunotherapy combinations and anti‑VEGF tyrosine kinase inhibitors are available for unresectable HCC, an estimated 25–30% of patients are not eligible for these therapies. In HIMALAYA, durvalumab monotherapy demonstrated non‑inferior overall survival versus sorafenib and demonstrated a favourable benefit risk profile for these patient groups with unresectable HCC. The approved regimen, known as the durvalumab monotherapy regimen, comprises of fixed dose of single agent Durvalumab, an anti-PDL-1 immunotherapy agent 1500 mg given every four weeks until disease progression or unacceptable toxicity. The CDSCO decision is supported by results from the HIMALAYA Phase III trial, in which durvalumab monotherapy achieved non‑inferior overall survival versus sorafenib with a favourable benefit risk profile in patients with unresectable HCC who had not received prior systemic therapy and were not eligible for locoregional treatment. ]]> https://biospectrumindia.com/news/22/27471/dcgi-warns-pharma-companies-against-improper-promotion-of-obesity-drugs.html https://biospectrumindia.com/news/22/27471/dcgi-warns-pharma-companies-against-improper-promotion-of-obesity-drugs.html Thu, 12 Mar 2026 00:00:00 +0530 The Drugs Controller General of India (DCGI) has issued a strong advisory cautioning pharmaceutical companies against direct or indirect promotion of prescription medicines used for obesity and metabolic disorders, particularly GLP-1 receptor agonists. In the advisory issued on March 10 through the Central Drugs Standard Control Organization (CDSCO), the regulator noted that certain companies may be engaging in surrogate promotional practices such as disease awareness campaigns, digital media outreach, and influencer-driven communication that indirectly create brand visibility and demand for prescription-only drugs among the general public. The regulator stressed that such promotional practices may violate provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, which prohibit advertisement of prescription medicines to the public. According to the advisory, any communication that exaggerates therapeutic benefits, suggests assured or guaranteed weight-loss outcomes, or downplays the importance of lifestyle modifications such as diet control, exercise, and behavioural interventions could be treated as misleading promotion. The DCGI emphasised that drugs like GLP-1 receptor agonists must only be prescribed by registered medical practitioners and used strictly in line with approved indications and conditions of marketing authorisation. The advisory further warns that promotional activities carried out under the pretext of disease awareness initiatives, corporate campaigns, or influencer engagement that lead to brand recall or product visibility of prescription medicines will be viewed seriously by regulators. Pharmaceutical manufacturers, importers, and marketing authorization holders have been directed to ensure strict compliance with regulatory norms, refrain from any form of direct or surrogate advertising across print, electronic, digital, or social media platforms, and adopt ethical marketing practices that do not exploit vulnerable populations. Additionally, companies have been asked to strengthen transparency and patient communication by ensuring that product information sheets and patient information leaflets clearly display details of authorized personnel, office codes, and dedicated contact numbers with complaint or ticket reference mechanisms. The regulator has also advised firms to submit comprehensive risk management plans to support ongoing safety monitoring and risk minimisation measures. The advisory has been shared with stakeholders and the Advertising Standards Council of India (ASCI) to reinforce compliance and prevent misleading promotion of prescription obesity drugs in the country. ]]> https://biospectrumindia.com/news/22/27468/niti-aayog-releases-fiscal-health-index-2026-report.html https://biospectrumindia.com/news/22/27468/niti-aayog-releases-fiscal-health-index-2026-report.html Wed, 11 Mar 2026 00:00:00 +0530 NITI Aayog Vice Chairman Suman Bery and NITI Aayog Chief Executive Officer (CEO) Nidhi Chhibber released the second annual "Fiscal Health Index 2026" report in New Delhi. The report was released in the august presence of other senior officials. The Fiscal Health Index provides a comprehensive and comparative assessment of the fiscal performance of Indian states. The index has been designed as a data-based framework that aims to assess fiscal prudence, guide reforms, and promote evidence-based fiscal policy-making across States. While the fiscal performance of 18 major states was evaluated in the first edition, the 10 North Eastern and Himalayan States have also been included in this edition. This has made the index more inclusive and representative of India's fiscal diversification. Keeping in view the structural differences between different regions, the North-East and Himalayan States have been assessed and ranked separately from the major States. Odisha continues to lead due to controlled deficits and stable revenues. Jharkhand and Gujarat record a slight gain in ranks despite small score declines, supported by stable debt and revenue flows. Arunachal Pradesh leads with strong expenditure quality and prudent debt management, while Uttarakhand benefits from high own-revenue mobilisation. The report lays emphasis on several policy priorities to strengthen the fiscal position in the states. These include increasing revenue raising capacity and strengthening the tax capacity of states; Rationalising fixed expenditure to restore fiscal resilience; Improving the structure and quality of capital expenditure; and adopting medium-term fiscal planning frameworks to manage deficit and debt trends more effectively. The report also emphasises the need to strengthen public financial management systems, enhance transparency through the use of verified fiscal data, and monitor out-of-budget debt more closely. ]]> https://biospectrumindia.com/news/22/27438/india-and-uzbekistan-launch-landmark-pharmaceutical-nutraceutical-trade-corridor.html https://biospectrumindia.com/news/22/27438/india-and-uzbekistan-launch-landmark-pharmaceutical-nutraceutical-trade-corridor.html Mon, 09 Mar 2026 00:00:00 +0530 In a strategic development set to reshape cross-border healthcare trade between South Asia and Eurasia, the Ministry of Health of the Republic of Uzbekistan has aligned with Nutrify Today and Pharma Eurasia to formalise a structured Indo–CIS pharmaceutical and nutraceutical corridor—positioning Uzbekistan as the region’s premier gateway to the Commonwealth of Independent States (CIS) and the wider Eurasian market. The trilateral initiative integrates policy facilitation, global industry leadership, and a dedicated commercial exhibition platform—creating a scalable and compliance-driven trade architecture for Indian and global manufacturers seeking structured access into high-growth Eurasian markets. Uzbekistan has rapidly transformed into a regional pharmaceutical and nutraceutical hub through targeted industrial policy, including: Dedicated Pharma Parks and industrial clusters designed to attract FDI and contract manufacturing Regulatory modernisation aligned with international compliance standards Strategic geographic positioning between India, Russia, and Central Asia Trade-focused institutional reforms and investment facilitation frameworks The commercial activation of this corridor will take place at Pharma Eurasia 2026, scheduled for 20–22 May 2026 in Tashkent, Uzbekistan. Nutrify Today will deploy AI-driven regulatory intelligence and compliance infrastructure to support transparent and scalable cross-border nutraceutical trade. For Indian pharmaceutical and nutraceutical exporters, this corridor represents one of the most structured and policy-backed market-entry opportunities available today. ]]> https://biospectrumindia.com/news/22/27420/dr-jitendra-singh-proposes-india-delaware-biomanufacturing-working-group.html https://biospectrumindia.com/news/22/27420/dr-jitendra-singh-proposes-india-delaware-biomanufacturing-working-group.html Mon, 02 Mar 2026 00:00:00 +0530 Union Minister for Science and Technology, Dr Jitendra Singh said that India and the United States should move towards a structured India-Delaware partnership in advanced biomanufacturing. He proposed the setting up of a small working group to convert discussions into results for concrete collaborations in research, manufacturing and startup ecosystem. The proposal came during a meeting of the US delegation led by Delaware Governor Matt Meyer, who called on Dr Jitendra Singh at Seva Teerth. Both sides focused on bilateral cooperation in pharma, biotechnology, clean energy and innovation-led industrial development. Dr Jitendra Singh emphasised that Science, Technology and Biotechnology are the key pillars of the Indo-US Comprehensive Strategic Partnership. He said India sees "good potential for deeper engagement" with the US countries that have strong innovation ecosystems. He highlighted India's emergence as a global hub for innovation in the field of biotechnology and pharmaceuticals, with its potential spanning from research and development to large-scale, cost-effective manufacturing. Referring to Delaware's bioscience ecosystem, Dr Jitendra Singh said there is a strong potential for collaboration in advanced biomanufacturing, AI-enabled processes, rapid scale production technologies, and next-generation biologics and vaccines, including the National Institute for Innovation in Biopharmaceutical Manufacturing (NIIMBL). He suggested that India's capability in affordable manufacturing, and Delaware's proximity to major US pharmaceutical companies can be instrumental in the development of affordable biologics, biosimilars, and vaccines for global health needs. Dr Jitendra Singh also outlined specific areas of collaboration, including the Joint Advanced Bio-manufacturing Platform, Translational Research Bridges connecting Indian institutions and Delaware research centres, startup and incubation linkages, and workforce training in GMP manufacturing, regulatory sciences and quality systems.  At the conclusion of the meeting, both sides agreed that a structured working group system would be helpful in taking forward discussions in practical programmes, including joint research proposals, startup exchanges, and institutional partnerships. This collaboration adds state-level dimensions to the India-US Comprehensive Strategic Partnership, with biotechnology and advanced manufacturing emerging as priority areas for the next phase of cooperation. ]]> https://biospectrumindia.com/news/22/27401/govt-promotes-indigenous-car-nk-cell-therapy-platform-for-oncology-and-treatment-of-leishmaniasis.html https://biospectrumindia.com/news/22/27401/govt-promotes-indigenous-car-nk-cell-therapy-platform-for-oncology-and-treatment-of-leishmaniasis.html Thu, 26 Feb 2026 00:00:00 +0530 The Technology Development Board (TBD) under the Department of Science and Technology (DST), Government of India, has awarded the project "CAR-NK Based Cell Therapy Development and Clinical Trials for Defect-to-Treat Tumors and Leishmaniasis" to East Ocean Bio , Gurugram. Financial assistance has been provided for this. The project aims to establish the first platform-based ecosystem in India for off-the-shelf CAR-NK cell therapy targeting resistant solid tumours and negligible infectious diseases. It aims to strengthen India's capabilities in the field of Advanced Immunotherapy and Biotherapeutics manufacturing. CAR-NK (Chimeric Antigen Receptor–Natural Killer) cell therapy is emerging as an expandable and potentially safer alternative to traditional autologous (based on the patient's own cells) CAR-T therapy.  Under the project, the company proposes to develop and commercialise the following: Anti-PD-L1 CAR-NK cell therapy for the treatment of a variety of resistant solid tumors, which are able to escape the body's immune system. CAR-NK therapy targeting leishmaniasis: This represents a new immunotherapeutic strategy for tropical diseases that are extremely important and neglected from the point of view of public health in India. This technology platform is developed entirely in-house (indigenously), focusing on allogeneic and off-the-shelf CAR-NK and CAR-γδ T cell therapies derived from healthy donors. They are engineered in large quantities, cryopreserved (secured at low temperatures) under GMP-adaptable systems, and can be used directly without any patient matching—which makes its scalability, cost-effectiveness, and rapid deployment possible. The main feature of this innovation is to integrate PD-L1-targeted CAR constructs into NK cells using a gamma-retroviral platform, which ensures high expression efficiency and long-term functionality.   ]]> https://biospectrumindia.com/news/22/27389/india-brazil-meet-to-unlock-opportunities-in-biosimilars-complex-therapies.html https://biospectrumindia.com/news/22/27389/india-brazil-meet-to-unlock-opportunities-in-biosimilars-complex-therapies.html Wed, 25 Feb 2026 00:00:00 +0530 The Pharmaceutical Export Promotion Council of India (PHARMEXCIL) supported the India–Brazil Healthcare Business Gateway held at Taj Palace, New Delhi recently, bringing together Indian pharmaceutical manufacturers, regulatory authorities, and Brazilian healthcare leaders. Organised by Amoveri Farma during the official visit of the Brazilian delegation, the closed-door meeting focused on expanding cooperation in oncology medicines, biosimilars, complex therapies, and hospital technologies, while facilitating structured access to the Brazilian market. Pharmexcil Chairman Namit Joshi emphasised, “Brazil represents a significant opportunity for Indian MSME pharmaceutical manufacturers, particularly in specialty medicines, public healthcare supply, technology partnerships and regulatory collaboration. Indian companies possess the technological capability as well as the manufacturing scale required to expand high-quality medicines’ access for the Brazilian population. This meeting represents a strategic step toward deepening this pharmaceutical collaboration between India and Brazil. PHARMEXCIL remains committed to supporting initiatives that foster sustainable partnerships and facilitate responsible entry into the Brazilian market.” iPHEX 2026, scheduled for 7-9 September 2026 is also set to serve as a global platform to showcase India's pharmaceutical capabilities, fostering innovation and international partnerships. India's pharmaceutical exports to Brazil have shown significant growth, with the country currently ranked as the second-largest destination for Indian pharma exports by share. Overall Export Performance (Values in $ Million) • FY 2024-25: Total exports reached $778.49 million, an 18.74% increase from $655.64 million in FY 2023-24. • Apr-Jan FY26 (Current Period): Exports totalled $740.33 million, reflecting a 17.03% growth compared to the $632.59 million recorded during the same period in FY25. • Market Share: Brazil accounts for approximately 2.88% of India's total country-wise pharmaceutical exports. ]]> https://biospectrumindia.com/news/22/27374/karnataka-health-minister-assures-state-rare-diseases-policy-soon.html https://biospectrumindia.com/news/22/27374/karnataka-health-minister-assures-state-rare-diseases-policy-soon.html Mon, 23 Feb 2026 00:00:00 +0530 The Organization for Rare Diseases India (ORDI), a national patient advocacy organization committed to addressing challenges faced by people with rare diseases in India, hosted the 11th edition of its flagship annual awareness marathon, Racefor7, on February 22 in Bengaluru. Karnataka Health Minister, Dinesh Gundu Rao flagged off the Racefor7 in Bengaluru, extending strong support to the Rare Diseases community. Addressing participants, he announced that the Karnataka State Rare Diseases Policy will be released shortly, assuring families that the Government is committed to ensuring that no Rare Disease patient is left out. Racefor7, led by Organization for Rare Diseases India (ORDI), is a nationwide awareness movement advocating for early diagnosis, equitable access to treatment, and sustainable long-term care for individuals living with Rare Diseases.  The Minister’s assurance marks a significant step forward for Karnataka’s Rare Disease ecosystem and brings renewed hope to patients and caregivers across the State. The theme for this year’s awareness run, “Run for Rare for Lasting Care,” underscored the collective responsibility of patients, caregivers, healthcare professionals, policymakers, and the public in building a more inclusive and supportive ecosystem for the rare disease community.  ]]> https://biospectrumindia.com/news/22/27375/india-and-brazil-sign-mou-to-strengthen-cooperation-in-pharma-and-medical-products-regulation.html https://biospectrumindia.com/news/22/27375/india-and-brazil-sign-mou-to-strengthen-cooperation-in-pharma-and-medical-products-regulation.html Mon, 23 Feb 2026 00:00:00 +0530 India and Brazil have signed a Memorandum of Understanding (MoU) to strengthen bilateral cooperation in the field of regulation of pharmaceutical medical products. The MoU was signed between the Central Drugs Standard Control Organization (CDSCO) of India and the Brazilian Health Regulatory Agency (ANVISA), marking a significant step towards deeper regulatory cooperation between the two countries. The Director President, ANVISA, Leandro Safatale and the Indian Ambassador to Brazil, Dinesh Bhatia, exchanged the Memorandum of Understanding in the august presence of Prime Minister Narendra Modi and President of Brazil Luiz Inácio Lula da Silva at Hyderabad House. The MoU will establish a structured framework for cooperation and exchange of information in the field of pharmaceutical products, pharmaceuticals, biological products and medical devices. It aims to promote uniformity in regulatory processes, enhance mutual understanding of regulatory systems, and facilitate effective and coordinated monitoring of medical products. The agreement reflects the shared commitment of India and Brazil to ensure availability of safe, effective and quality medicines and medical products for their populations. The agreement is also expected to contribute to strengthening supply chains, encouraging regulatory best practices, and promoting access to affordable healthcare solutions. The MoU between CDSCO and NVISA will further strengthen the extensive Indo-Brazil cooperation in the health sector and complement the existing institutional mechanisms for bilateral engagement. The MoU underscores the growing cooperation between the two countries in the field of health, pharmaceuticals, and medical technologies, particularly in the context of their shared priorities as leading partners of the Global South. ]]> https://biospectrumindia.com/news/22/27367/india-rwanda-discussions-lay-focus-on-artificial-intelligence-biomanufacturing-and-emerging-technologies.html https://biospectrumindia.com/news/22/27367/india-rwanda-discussions-lay-focus-on-artificial-intelligence-biomanufacturing-and-emerging-technologies.html Sat, 21 Feb 2026 00:00:00 +0530 Union Minister of State (Independent Charge) for Science and Technology Dr Jitendra Singh said that India is poised to deepen its engagement with Rwanda in emerging technologies, innovation ecosystem and next-generation sectors including Artificial Intelligence, Biotechnology and Atomic Energy. Because the two countries are looking for a structured framework for bilateral cooperation. Dr Jitendra Singh held a bilateral meeting with Paula Ingbire, Minister of Information and Communication Technology and Innovation, Government of Rwanda at Sewa Tirtha, New Delhi.  Recalling the long-standing cordial relations between the two countries, Dr Jitendra Singh said, India's engagement with African countries in the field of Science and Technology has grown steadily under the framework of the India-Africa Forum Summit. He commended the selection of Rwanda as the first country to implement the Technology Transfer Programme for Africa and mentioned the successful India-Rwanda Innovation Development Programme (IRIGP), which has served as a model for similar collaborations across the continent.   Highlighting India's strong position in life sciences and biotechnology, Dr Jitendra Singh spoke about major national initiatives in the field of genomics, gene therapy and bio-manufacturing. He referred to the Bio-Nirmal Shakti Mission announced in the current financial year for which an initial allocation of Rs 10,000 crore has been made to promote high-quality, affordable medical devices, implants, and advanced healthcare solutions. From the Rwandan side, Minister Paula Ingbire spoke about Rwanda's efforts to establish itself as a pan-African technology and innovation hub, centered around initiatives such as the Kigali Innovation City and AI Scaling Hub supported by global partners. The Rwanda delegation expressed interest in strengthening cooperation in artificial intelligence, health technology, life sciences, energy and innovation ecosystems. Both sides discussed the possibility of connecting Indian innovation hubs, incubators and startups with their counterparts in Rwanda for mentoring, training and joint research. It was also discussed that a draft of a Memorandum of Understanding (MoU) on bilateral cooperation in the field of science, technology and innovation has been shared by Rwanda through the Ministry of External Affairs.   ]]> https://biospectrumindia.com/news/22/27357/ai-will-open-up-high-value-opportunities-leading-to-innovation-and-entrepreneurship-pm.html https://biospectrumindia.com/news/22/27357/ai-will-open-up-high-value-opportunities-leading-to-innovation-and-entrepreneurship-pm.html Thu, 19 Feb 2026 00:00:00 +0530 Prime Minister Narendra Modi inaugurated the India AI Impact Summit 2026 at Bharat Mandapam in New Delhi, on 19th February. Addressing the gathering, Modi said that the world's largest and historic AI Impact Summit is taking place in India, which represents one-sixth of humanity. He said that India has the world's largest youth population, the largest tech talent pool and a rich technology-enabled ecosystem. He said that India not only creates new technologies but also adopts them at an unprecedented pace. The Prime Minister said that 14 crore Indians are keen to adopt new technologies, and on his behalf, he extended a warm welcome to the Heads of State, leaders of the global AI ecosystem and innovators participating in the Summit.  Modi said AI will open up high value, creative and meaningful opportunities for more people, leading to innovation, entrepreneurship and new industry opportunities. He stressed on the importance of making skill development, redevelopment and lifelong learning a people's movement. The Prime Minister said that the future of work will be inclusive, trustworthy and human-centric, and if humanity moves forward together, Artificial Intelligence will take human potential to new heights. The event was attended by the President of France, Emmanuel Macron, Secretary General of the United Nations, several Heads of State, Ministers, senior representatives of multilateral institutions and other dignitaries including technology and AI giants. Artificial intelligence is also a transformative force, it disrupts if directionless, but becomes a solution when it gets the right direction. Modi said the basic objective of the Global AI Impact Summit is to deliberate on how to make Artificial Intelligence human-centric, sensitive and responsive instead of machine-centric. ]]> https://biospectrumindia.com/news/22/27340/health-ministry-announces-two-landmark-initiatives-at-india-ai-summit.html https://biospectrumindia.com/news/22/27340/health-ministry-announces-two-landmark-initiatives-at-india-ai-summit.html Tue, 17 Feb 2026 00:00:00 +0530 Union Minister of Health and Family Welfare Jagat Prakash Nadda launched two important national initiatives – India's Strategy for Artificial Intelligence in Healthcare (SAHI) and the Benchmarking Open Data Platform (BODH) for Health Artificial Intelligence – at the India AI Summit at Bharat Mandapam. SAHI is the national guiding framework to enable the adoption of AI in India's healthcare system in a safe, ethical, evidence-based and inclusive manner. It aims to provide critical direction on the operation, data management, validation, application, and monitoring of AI solutions, as well as assist states and institutions in adopting it in a responsible manner in line with public health priorities. The Benchmarking Open Data Platform (BODH) for AI in Healthcare, developed by the Indian Institute of Technology, Kanpur in collaboration with the National Health Authority, is a private privacy-safeguarding standard platform that enables accurate evaluation of AI models using diverse, real-time health data without sharing the underlying dataset. As a Digital Public Resource under Ayushman Bharat Digital Mission, it has been designed to strengthen trust, transparency, and quality assurance in the use of AI in the health sector. ]]> https://biospectrumindia.com/news/22/27329/first-national-call-for-rs-2000-cr-birac-rdi-fund-to-boost-biotechnology-sector.html https://biospectrumindia.com/news/22/27329/first-national-call-for-rs-2000-cr-birac-rdi-fund-to-boost-biotechnology-sector.html Sat, 14 Feb 2026 00:00:00 +0530 Union Minister of State (Independent Charge), Science & Technology, Dr Jitendra Singh has announced the first national call for BIRAC-RDI Fund to promote high-impact Biotechnology innovations under the Government of India's Rs 1 lakh crore Research, Development and Innovation (RDI) initiative. Referring to the emerging areas, the Minister said that India has already forayed into areas like space biotechnology and is preparing for future areas such as space medicine. Biotechnology experiments are being carried out in space using domestically developed kits, including plant science and life sciences research. He said, such efforts position India to contribute knowledge and applications of global relevance, thereby enhancing both scientific prestige and geopolitical standing. Dr Rajesh S. Gokhale, Secretary, Department of Biotechnology; Director General, BRIC and Chairman BIRAC said that the structure of the RDI Fund is designed to support long-term, high-risk research, which requires patient capital and advanced infrastructure. He said that this initiative complements the Bio E3 policy and provides a framework for manufacturing next-generation products in biopharma, bio-industrial production, bioenergy, blue economy and bio-computation. He said that the aim is to reach out from the research results to the industrial results on a large scale. Dr Jitendra Kumar, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC) said that BIRAC has been appointed as a second-level fund manager under the RDI framework and it will invest an amount of Rs 2,000 crore over the next five years, with the possibility of further expansion. He said that BIRAC has built an innovation ecosystem across the country in the last decade, which includes more than 100 Bio-Incubation Centres, more than 10 lakh square feet of incubation space, and collaborations with more than 15 lakh startup entrepreneurs. The BIRAC – RDI Fund is part of the National RDI Initiative that was approved by the Union Cabinet in July 2025 and launched in November 2025 under the Research National Research Foundation (ANRF), which is steered by the Department of Science and Technology. The fund aims to bridge the gap between laboratory research and industrial-scale manufacturing, and it supports technology from TRL-4 to TRL-9 through a mix of equity, convertible documentation, and long-term debt. The national call for applications is now open. Eligible startups, small and medium enterprises (SMEs), and industry partners can submit proposals through the official portal https://biracrdif.org. The last date for Phase 1 is March 31, 2026. ]]> https://biospectrumindia.com/news/22/27303/drug-code-commission-of-india-inks-three-mous-to-strengthen-drug-safety-quality-standards-and-capacity-building.html https://biospectrumindia.com/news/22/27303/drug-code-commission-of-india-inks-three-mous-to-strengthen-drug-safety-quality-standards-and-capacity-building.html Tue, 10 Feb 2026 00:00:00 +0530 The Indian Pharmacopoeia Commission (IPC), an autonomous body under the Union Ministry of Health and Family Welfare, has signed Memorandums of Understanding (MoU) with Goa State Pharmacy Council (GSPC), Quality Council of India (QCI) and HLL Infra Tech Services Limited (HITES) to strengthen safety, quality assurance and capacity building initiatives of drugs in the country. Under the Memorandum of Understanding (MoU) between the Drugs Code Commission of India (IPC) and the Goa State Pharmacy Council (GSPC), a structured framework has been created for cooperation in the areas of pharmacovigilance, rational use of drugs and professional development of pharmacists in Goa. It aims to promote India's National Formulary among registered pharmacists, strengthen reporting mechanism on Adverse Drug Reaction (ADR) under India's Pharmacovigilance Programme, conduct training programmes, workshops and continuing education activities and facilitate awareness initiatives related to drug safety, pharmacopoeial standards and portable pharmacopoeia. The MoU aims to support the establishment and capacity building of Adverse Drug Response Surveillance Centres and improve systematic reporting and documentation practices in health facilities across the state. Under the MoU between the Drugs Code Commission of India and the Quality Council of India, the two institutions have agreed to collaborate in the areas of quality promotion, public health awareness and capacity building. The cooperation includes joint planning and implementation of training and awareness programmes, utilisation of institutional expertise and technical resources, and collaborative initiative development in line with national quality and safety objectives, especially in drug vigilance and related topics. The MoU is to provide a situational, non-binding framework to facilitate project-based cooperation wherein specific activities will be carried out through mutually agreed mechanisms. These will ensure quality assurance and comprehensive standardisation in the healthcare sector.   ]]> https://biospectrumindia.com/news/22/27290/govt-launches-first-rdi-fund-call-inaugurates-unique-initiative-of-innovation-financing.html https://biospectrumindia.com/news/22/27290/govt-launches-first-rdi-fund-call-inaugurates-unique-initiative-of-innovation-financing.html Thu, 05 Feb 2026 00:00:00 +0530 Dr Jitendra Singh, Minister of State with Independent Charge for Science & Technology, has launched the first Open Call of Technology Development Board (TDB) under the Research, Development and Innovation (RDI) Fund of the Anusandhan National Research Foundation (ANRF). It aims to strengthen India's innovation ecosystem by supporting the commercialisation of indigenous technologies through structured, long-term financing. Addressing the event, Dr Jitendra Singh said, this initiative represents a rare and significant deviation from traditional government funding models. He observed that while governments have traditionally encouraged philanthropy or CSR-led investment, direct government-backed financial support for private sector innovation has been limited. He said that the RDI Fund seeks to bridge this gap, allowing private enterprises to scale technologies in strategic sectors that were previously limited to the public sector. The Minister noted that the opening up of strategic sectors such as the space and nuclear sectors to private participation has changed long-standing traditions, and the RDI Fund is designed to support this same transition, reducing financial risk while ensuring accountability. He added that the fund provides long-term, affordable financing and incorporates equity-linked options for risk sharing, thereby supporting responsible commercialization. Dr Jitendra Singh informed that the total corpus of the RDI Fund is Rs 1 lakh crore and it provides financing at concessional interest rates of around 2–4 per cent, including long tenure and moratorium provisions of up to 15 years. He said that this structure is designed to make it easier for technology developers to access capital while maintaining financial discipline.   It was clarified during the event that TDB's first call under the RDI Fund focuses on supporting projects at the Technology Readiness Level (TRL) 4 and above. Funding support will be provided through Second Level Fund Managers (SLFMs) in the form of loans, equity, or hybrid instruments, depending on the project's requirements. The maximum funding support will be up to 50 percent of the total project cost, with equal contributions from companies or private investors. The funding framework provides unguaranteed financing, with no need for individual or corporate guarantees. The proposal evaluation will be conducted based on scientific, technological, financial, and business merit, with set timelines for evaluation and delivery. This initiative does not provide grant funding and focuses on enabling sustainable business deployment of technologies.   ]]> https://biospectrumindia.com/news/22/27260/union-budget-2026-27-announces-biopharma-shakti-with-total-outlay-of-rs-10000-cr-and-much-more.html https://biospectrumindia.com/news/22/27260/union-budget-2026-27-announces-biopharma-shakti-with-total-outlay-of-rs-10000-cr-and-much-more.html Sun, 01 Feb 2026 00:00:00 +0530 The Union Budget for 2026-27 was presented by the Finance Minister Nirmala Sitharaman on 1st February 2026. With an aim to develop India as a global biopharma manufacturing hub, the Union Budget has proposed the Bioforma Shakti (Strategy for Modernising Health Services through Knowledge, Technology and Innovation) programme. Under this, Rs 10,000 crore has been earmarked for the next five years. The programme will create an ecosystem for production of biologicals, products and bio-drugs domestically. As per the budget, three new National Institutes of Pharmaceutical Education and Research (NIPERs) with a focus on Biopharma, will be built, alongside upgradation of seven existing institutions. The budget has also proposed creation of a network of more than one thousand recognised Indian clinical trial sites. The Union Budget also proposes to strengthen the Central Drugs Standard Control Organisation to meet global standards and for timely approval through a dedicated scientific review cadre and experts. The Finance Minister has announced a slew of measures aimed at building a new range of employable and career-important skilling activities for youth in a variety of sectors, including public health services. For Allied Health Care Professionals, existing institutions will be upgraded and new programmes will be set up in the private and government sectors, along with establishment of new institutions. It will cover 10 major medical disciplines including Optometry, Radiology, Anaesthesia, OT Technology, Applied Psychology and Mental Health. In this direction, 1 lakh Allied Health Care Professionals will be added in the next five years. In her speech, the Finance Minister said that a robust care ecosystem will be created covering the elderly and specialised care services. A series of National Skills Qualifications Framework (NSQF)-aligned programmes will be developed to prepare multi-skill service providers with use and implementation of wellness, care, yoga and medicine and assistive devices. As a result, about one and a half lakh care service providers will be trained in the next few years. In order to expand India as a hub for medical tourism services, the Union Budget has proposed a special programme to assist the States under which five Regional Medical Centres will be set up with private sector participation. These centres will serve as integrated healthcare service provider complexes providing medical, education and research facilities at one place. Ayush Centres, Medical Tourism Facilitation Centres and special centres for screening, post-treatment and de-addiction will also be set up at these locations. All these centres will provide different employment opportunities to medical professionals, including doctors and allied healthcare professionals. Emphasising on the ayurveda sector, three new All India Institutes of Ayurveda will be set up. An announcement has also been made to upgrade AYUSH pharmacy and drug testing laboratories to the highest standards of certification environment and to provide more skilled personnel, and to promote evidence-based research, training and awareness for traditional medicines. The WHO Global Traditional Medicine Centre in Jamnagar, Gujarat, has been approved for the development of the Pharmacy of Ayush Pharmacy and Drug Testing Laboratories. With a commitment to mental health and trauma care, NIMHANS-II will be set up for mental health in North India, while the National Institutes of Mental Health at Ranchi and Tezpur will be upgraded to regional apex institutions. Along with this, a provision has been made to increase the capacity of emergency services in district hospitals and increase the emergency care centres and trauma care centres by about 50 percent. According to this year’s Union Budget, a robust care ecosystem will be created encompassing geriatric medical and allied care services. One and a half lakh care service providers will be trained in the next few years. Further, The budget proposes to provide assistance to Artificial Limbs Manufacturing Corporation of India (ALIMCO) for increasing production of assistive devices, investment in research and development and AI integration. Basic customs duty will be waived on 17 cancer medicines, with 7 individual export of drugs for additional rare diseases to be exempted from tax.   Click here for the industry's comments  ]]> https://biospectrumindia.com/news/22/27249/health-ministry-to-reduce-regulatory-burden-and-promote-ease-of-doing-pharma-business.html https://biospectrumindia.com/news/22/27249/health-ministry-to-reduce-regulatory-burden-and-promote-ease-of-doing-pharma-business.html Thu, 29 Jan 2026 00:00:00 +0530 In line with Prime Minister Narendra Modi's directions to reduce regulatory burden and promote ease of doing business, the Union Ministry of Health and Family Welfare has notified significant amendments to the New Drugs and Clinical Trials Rules, 2019. These amendments aim to simplify regulatory processes, reduce approval timelines, and expedite clinical research and drug development in the country. Under the existing regulatory framework, pharmaceutical companies were required to obtain a test license from the Central Drugs Standard Control Organisation (CDSCO) for manufacture of limited quantities of drugs for the purposes of testing, research or analysis. Through the notified amendments, this licensing requirement for non-commercial construction has been replaced by the Early Notice System. As a result, the industry will no longer be required to obtain a test license and drug development work can be pursued by submitting information online to CDSCO, except in the case of a limited category of high-risk drugs, including cytotoxic drugs, narcotic drugs, and psychotropic substances. This improvement is likely to save at least 90 days in the life cycle of drug development, providing a significant boost to pharmaceutical research and innovation. Also, for categories that still require a test license, the statutory process time limit has been reduced from 90 days to 45 days. Since CDSCO processes about 30,000 to 35,000 test license applications every year, this reform can be helpful in reducing the regulatory burden and providing benefits to a large number of stakeholders. In an effort to expedite clinical research, the requirement of prior approval for certain low-risk bioavailability and bioequivalence (BA/BE) studies has been done away with. Now such studies can be initiated only by giving a simple online information to CDSCO, which will speed up and facilitate the process of these studies, especially in the area of generic medicines. It may be noted that CDSCO processes around 4,000 to 4,500 BA/BE study applications every year, and the time taken in the processes is likely to be significantly reduced under this new mechanism. To ensure smooth and seamless implementation of these changes, dedicated online modules will be made available on the National Single Window System and Sugam Portal which will enable the industry to submit information in a transparent and hassle-free manner.   ]]> https://biospectrumindia.com/news/22/27235/indiaeu-free-trade-agreement-marks-breakthrough-in-indias-global-trade-engagement.html https://biospectrumindia.com/news/22/27235/indiaeu-free-trade-agreement-marks-breakthrough-in-indias-global-trade-engagement.html Tue, 27 Jan 2026 00:00:00 +0530 Prime Minister Narendra Modi and European Commission President Ursula von der Leyen, have jointly announced the conclusion of the India–European Union Free Trade Agreement (India–EU FTA) at the 16th India–EU Summit, held during the visit of the European leaders to India. This announcement marks a historic milestone in India–EU economic relations and trade engagement with key global partners. The European Union is India’s one of the largest trading partner, with bilateral trade in goods and services growing steadily over the years. In 2024–25, India’s bilateral trade in goods with the EU stood at Rs 11.5 Lakh Crore ($136.54 billion) with exports worth Rs 6.4 Lakh Crore ($75.85 billion) and imports amounting to $5.1 Lakh Crore ($60.68 billion). India-EU trade in services reached Rs 7.2 Lakh Crore ($83.10 billion) in 2024. India has also secured access for practitioners of Indian Traditional Medicine to work under home title in EU Member States where traditional medical practices are not regulated. From the medtech perspective, Pavan Choudary, Chairman, Medical Technology Association of India (MTaI), said, “We congratulate India and the European Union on concluding this landmark agreement, which is expected to open a new chapter in healthcare cooperation - where success will be measured not only in GDP, but in lives improved and saved. If the fine print is in line with the announcements made, this FTA will enable India to strengthen its role as a reliable, innovation-driven partner by expanding exports of medical textiles, surgical instruments and disposables which India specialises in. European companies in India are hoping to benefit from lower duties, stronger participation in public procurement, and greater incentives for local manufacturing and R&D. Most importantly for patients, any eventual tariff reductions on medical devices should help improve affordability and access to advanced therapies, making this agreement a potential example of how ethical and equitable trade can reinforce health systems on both sides.” “The proposed reduction in EU tariffs on industrial and medical equipment is a significant and timely step that can accelerate the global competitiveness of Indian MedTech innovation. For companies like SS Innovations, which are developing advanced, Made-in-India surgical robotic systems, lower tariff barriers open new opportunities to scale exports, improve price competitiveness, and strengthen India’s position as a trusted global manufacturing hub. This policy move not only supports trade efficiency but also reinforces the growing acceptance of high-quality Indian medical technologies in regulated international markets such as the EU”, said Dr. Vishwa Srivastava, CEO - APAC, SS Innovations International Inc.  Adding another perspective, Suresh Nair, Partner, Indirect Tax, EY India said, "The India–EU Free Trade Agreement provides substantial benefits for the pharmaceutical and medical devices sectors, subject to phased implementation and final ratification details. The EU will eliminate tariffs of up to 11% on pharmaceuticals and reduce tariffs on approximately 90% of medical  devices from up to 27.5% to zero. The agreement strengthens regulatory cooperation, simplifies compliance procedures, and enhances intellectual property protections, improving the competitiveness of Indian exporters in this sector." “The value of the India–EU trade deal extends far beyond headline tariff reductions. India’s pharmaceutical exports to Europe currently account for just 19% of total exports, underscoring the scale of opportunity ahead rather than any structural constraint. For those of us in preventive healthcare, the gains from this deal go far beyond export volumes. Europe’s regulatory depth and science-led approach will facilitate stronger clinical validation, better traceability, and higher compliance standards in India. That discipline will ultimately build consumer trust in nutraceuticals, not only in Europe but across the globe. At the same time, Europe’s ageing population and focus on wellness align naturally with India’s ayurveda knowledge, strengths in nutrition science, and cost-efficient advanced manufacturing. This is how India moves from being a supplier to becoming a global health partner", said Sanjaya Mariwala, Executive Chairman and Managing Director of OmniActive Health Technologies. Further, the FTA is expected to facilitate cooperation in critical areas like Artificial Intelligence, clean technologies, and semiconductors, supporting India's technological advancement. ]]> https://biospectrumindia.com/news/22/27208/telangana-sets-global-ambition-with-life-sciences-policy-202630-targeting-25-b-investments.html https://biospectrumindia.com/news/22/27208/telangana-sets-global-ambition-with-life-sciences-policy-202630-targeting-25-b-investments.html Wed, 21 Jan 2026 00:00:00 +0530 The Government of Telangana unveiled its Next-Gen Life Sciences Policy 2026–30 at the World Economic Forum Annual Meeting in Davos, signalling the State’s intent to play a far more consequential role in shaping the future of global healthcare, advanced therapeutics, and sustainable bio-manufacturing. With a clear ambition to rank among the top five life sciences clusters worldwide by 2030, the policy targets $25 billion in investments, creation of 500,000 high-quality jobs, and deeper integration into global life sciences value chains. The policy was unveiled by Chief Minister A. Revanth Reddy in the presence of the Minister for IT & Industries, D. Sridhar Babu; Special Chief Secretary Sanjay Kumar IAS, and the CEO, Telangana Lifesciences, Shakthi M. Nagappan.   The policy implementation will be anchored by globally benchmarked infrastructure, including the Green Pharma City, ten Pharma Villages, expansion of Genome Valley, and further strengthening of the Medical Devices Park. Key Focus Areas of the Policy- Frontier R&D and Advanced Manufacturing: Promotion of next-generation technologies and platforms, including biologics and biosimilars, cell and gene therapy, mRNA platforms, CRISPR technologies, antibody-drug conjugates (ADCs), oligonucleotides, peptides, and precision fermentation, with a focus on value-added and technology-intensive manufacturing. Clinical Research: Strengthening the clinical trial ecosystem by enabling faster approvals, creation of disease-specific clinical registries, and operationalization of initiatives such as the Clinical Innovation Sandbox Pharma Services: Expansion of the pharma services ecosystem, including Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs), to scale the sector from the current estimated size of USD 2 billion to approximately USD 10 billion. Diagnostics and Medical Electronics: Development of a robust hub for research, development, and manufacturing of diagnostics and medical electronics. Global Value Centres and Global Innovation Centres: Attracting Global Capability Centres (GCCs) and Global Innovation Centres focused on advanced analytics, artificial intelligence, engineering, digital health, and high-end R&D functions in the life sciences and healthcare domains. Precision Medicine and Personalized Therapies: Advancing precision medicine through the development of clinical registries and privacy-compliant digital health records to enable personalized therapies, data-driven healthcare interventions, and improved clinical outcomes.   Strategic Levers for Implementation: Infrastructure Development: The policy proposes the creation of world-class infrastructure to support the full life sciences value chain, including: ·       Establishment of the Green Pharma City, a sustainable and integrated industrial cluster incorporating zero liquid discharge (ZLD), centralized waste management, energy-efficient systems, and net-zero practices. ·       Development of ten (10) Pharma Villages, each spanning approximately 1,000 to 3,000 acres along the Outer Ring Road (ORR), to promote decentralized, balanced, and inclusive industrial growth across the State. ·       Expansion of Genome Valley and establishment of a Bio-Innovation and Bio-Manufacturing Cluster in collaboration with Government of India, featuring multi-tenant laboratories and flatted factories to promote collaboration, innovation, and ease of entry for startups and MSMEs. ·       The Policy also envisages the expansion of the Medical Devices Park, with enhanced common infrastructure and plug-and-play facilities to support R&D and manufacturing in medical devices and diagnostics.   Talent Ecosystem: The policy emphasises the cultivation of a dynamic and future-ready workforce through initiatives such as the flagship Telangana School of Life Sciences and other skilling and capacity-building platforms. Key measures include industry-aligned curricula, structured internships, lifelong learning pathways, and certification programs across critical domains such as biologics, advanced analytics, artificial intelligence and bioinformatics, and Health Outcomes and Economic Research (HOER). Regulatory Streamlining and Ease of Doing Business: Implementation of TG-iPASS as a single-window system with time-bound approvals and deemed approvals in case of delays. The policy permits 24×7 operations in designated life sciences parks, subject to prescribed safety norms. A dedicated consultation committee (CDSCO, Telangana DCA, and TGPCB) to simplify state-level clearances and active advocacy with central regulators. Funding Ecosystem: Establishment of a dedicated Life Sciences Innovation Fund with an initial corpus of Rs 100 crore ($12 million), scalable to Rs 1,000 crore ($111 million), structured through a public-private partnership model with co-investment alongside venture capital and private equity funds to support startups, scale-ups, and translational research initiatives.   Industry responds- "Telangana has been setting the direction for the next phase of life sciences growth well ahead of the curve. Guided by the Hon’ble Chief Minister Shri Revanth Reddy's long-term vision and Shri D. Sridhar Babu, Hon’ble Minister for Industries, Commerce and IT passionate leadership, our Life Sciences Policy 2026–30 anticipated this shift by prioritising advanced and complex manufacturing, deep innovation and R&D, and the creation of a strong, globally integrated clinical research and clinical trial network. The Union Budget’s focus on precisely these areas now amplifies this momentum, accelerating our goal of attracting $25 billion in investments and generating 500,000 jobs while reinforcing Hyderabad’s position as a global life sciences innovation hub.” Shakthi M. Nagappan, CEO, Telangana Life Sciences   “Telangana’s Next-Gen Life Sciences Policy 2025–30 is a timely and thoughtful step that reinforces the state’s ambition to be among the world’s leading life sciences hubs. By focusing on innovation-led growth, advanced manufacturing, and a strong science and talent ecosystem, the policy creates a compelling platform for companies like Sai Life Sciences to continue partnering with global innovators and advancing high-quality R&D from India for the world.” Krishna Kanumuri, MD & CEO, Sai Life Sciences   “The life sciences sector in Telangana has emerged as a significant contributor to innovation, healthcare advancement, and economic growth, supported by a strong research base, growing industry presence, and a vibrant startup ecosystem. Building on this momentum, this Policy reflects a clear and timely vision to strengthen research capabilities, accelerate innovation, and translate scientific advances into meaningful health and economic outcomes. I am confident that the Telangana Next-Gen Life Sciences Policy will serve as a strong foundation for sustained growth and societal impact. I congratulate the Chief Minister and his entire team for taking this decisive step towards building a life sciences ecosystem that is resilient, inclusive and globally competitive." Satish Reddy, Chairman, Dr. Reddy's Labs   “The NextGen Telangana Life Sciences Policy signals a bold transition from scale-led growth to an innovation-driven, value-centric model that the global life sciences industry increasingly needs. With its strong manufacturing base, regulatory credibility, and forward-looking investments in precision medicine, data-driven discovery, and sustainable infrastructure, Telangana is creating an ecosystem that can effectively translate science into scalable global impact.  This policy has the potential to position the state among the world’s leading life sciences clusters and a credible global partner in shaping the future of healthcare.” Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Limited   “Telangana Next-Gen Life Sciences Policy 2026-30 is unique and transformative. It lays out a clear road map for being a dominant player in the emerging areas of healthcare, pivoting on innovation. This policy is a forward looking vision statement for the state which currently has a great life sciences ecosystem. Wishing all the success for this bold and ambitious vision.” Dr Satyanarayana Chava, Executive Director and Chief Executive Officer, Laurus Labs   "Telangana's Next-Gen Life Sciences Policy 2026–2030 represents a transformative vision that positions the State at the forefront of global life sciences innovation. With Hyderabad as a global hub at the centre of Sanofi’s operations, this policy's ambitious framework for advanced biomanufacturing, talent ecosystems, and regulatory excellence creates unprecedented opportunities to redefine how we serve patients globally. I commend the Hon'ble Chief Minister and the Hon'ble Minister of Industries for their bold leadership in shaping the future of life sciences.” Madeleine Roach, Executive Vice President, Business Operations, Sanofi   "At a moment when the global life sciences sector is undergoing profound transformation, Telangana’s Next-Generation Life Sciences Policy reflects a long-term vision that recognises the future of healthcare will be shaped not by isolated breakthroughs, but by strong ecosystems bringing together science, technology, talent, and policy coherence. By focusing on innovation, resilience, and global collaboration—and by anticipating the convergence of biology, data, and engineering—Telangana is positioning itself not just to participate in the future of life sciences, but to help shape it.” Shyam Bishen, Head of Centre for Health & Healthcare, Member of Executive Committee, World Economic Forum   "Telangana’s life sciences policy demonstrates a timely commitment to MedTech-led innovation. This kind of forward-looking policy framework is critical to accelerating innovation and building globally competitive MedTech hubs. Our Medtronic Engineering & Innovation Centre (MEIC) in Hyderabad is a testament to Medtronic’s investment and partnership with the state of Telangana and is focused on accelerating innovation and putting patients first. I congratulate the Telangana government for their leadership and vision in shaping a policy that meaningfully advances innovation in healthcare." Majid Kaddoumi, Executive Vice President, Eurasia   ]]> https://biospectrumindia.com/news/22/27201/chhattisgarh-eyes-investments-with-high-incentive-policy-and-dedicated-pharma-park.html https://biospectrumindia.com/news/22/27201/chhattisgarh-eyes-investments-with-high-incentive-policy-and-dedicated-pharma-park.html Tue, 20 Jan 2026 00:00:00 +0530 Chhattisgarh is stepping up efforts to position itself as a leading pharmaceutical and biotechnology hub in central India, backed by a high-incentive industrial policy, a dedicated pharma park at Nava Raipur and expanding healthcare and manufacturing infrastructure in the state. “Our objective is to convert investment intent into time-bound execution. We have identified Pharmaceuticals and biotechnology as priority sectors for industrial growth and our incentive framework is designed to ensure investors recover a significant part of their capital while establishing globally competitive manufacturing operations,” said Rajat Kumar, Secretary, Industry, Government of Chhattisgarh. "Pharmaceuticals and biotechnology have been classified as thrust sectors under the Industrial Development Policy 2024–30. Eligible units can avail industrial investment incentives of up to 100 percent of eligible fixed capital investment including reimbursement of net State GST paid for up to 12 years, subject to prescribed limits or alternatively opt for fixed capital investment grants,” he said. As per policy provisions, pharmaceutical projects with investments of Rs 50–200 crore are eligible for capital grants of up to Rs 60 crore, while projects in the Rs 200–500 crore range can avail grants of up to Rs 150 crore. Investments exceeding Rs 500 crore are eligible for capital grants of up to Rs 300 crore. Additional incentives include 100 percent exemption from electricity duty for 12 years, exemption from stamp duty, relief on registration charges and 50 percent reimbursement of charges for new electricity connections. Projects with investments above Rs 1,000 crore are eligible for customised incentive packages. A key anchor for the sector is the 142-acre dedicated pharma park at Nava Raipur, which is being developed as a plug-and-play manufacturing cluster for formulations, APIs, contract research and manufacturing services, medical devices and AYUSH products. The park will be supported by common infrastructure including need-based water supply, effluent treatment plants and solid waste management facilities under a PPP framework. The state offers a strong talent base, with over 50,000 graduates entering the workforce annually from institutions such as IIT, IIM, AIIMS, NIT, IIIT and NLU, supported by over 100 pharmacy colleges and 300 vocational training centres.  The pharmaceutical manufacturing ecosystem is being complemented by investments in healthcare and allied sectors. These include a 350-bed multi-speciality hospital planned in Bastar and the upcoming Bombay Hospital. The state has also recently received investment commitments from Shalby Hospitals for a multi-speciality hospital project and from Torrent Pharmaceuticals for pharmaceutical manufacturing. ]]> https://biospectrumindia.com/news/22/27185/ministry-of-tribal-affairs-inks-mou-with-icmr-regional-medical-research-centre.html https://biospectrumindia.com/news/22/27185/ministry-of-tribal-affairs-inks-mou-with-icmr-regional-medical-research-centre.html Sat, 17 Jan 2026 00:00:00 +0530 India's first National Capacity Building Programme of Tribal Vaidyas to strengthen health access in tribal areas was organised by the Ministry of Tribal Affairs (MoTA), Government of India on 16–17 January 2026 in Hyderabad, Telangana. This step has been prepared keeping in mind the Prime Minister's vision of inclusive, equitable and development based on the cultural roots of tribal communities. The programme represented a first-of-its-kind national initiative to formally recognise tribal and indigenous physicians as trusted community-level partners in India's public health system, integrating their capacity building. A major highlight of the event was India's first National Tribal Health Observatory between the Ministry of Tribal Affairs and the ICMR-Regional Medical Research Centre (RMRC), Bhubaneswar. A Memorandum of Understanding (MoU) was signed under Project Drishti for the establishment of the India Tribal Health Observatory (B-THO). This landmark collaboration will institutionalise tribe-specific health surveillance, implementation research, and research-induced disease elimination initiatives in tribal districts of the country, which will also address the long-standing national gap in tribal-specific health data, analytics, and policy evidence. The MoU with ICMR-RMRC will facilitate the development of a secure digital tribal health monitoring platform, which will include dashboards, GIS-enabled analytics, and periodic tribal health products. It will also enable dissemination of disease-specific implementation research in line with the India Tribal Family Health Survey (BTFHS) and national programmes such as the National Tuberculosis Elimination Programme (NTEP) and the National Centre for Vector Borne Disease Control (NCVBDC). Additionally, this collaboration will support capacity building of state and district health systems, as well as provide sensitisation and referral-oriented training for tribal vaidyas. ]]> https://biospectrumindia.com/news/22/27176/govt-launches-first-of-its-kind-national-initiative-breaking-barriers-fellowship-2026.html https://biospectrumindia.com/news/22/27176/govt-launches-first-of-its-kind-national-initiative-breaking-barriers-fellowship-2026.html Tue, 13 Jan 2026 00:00:00 +0530 Young Leaders for Active Citizenship (YLAC), the Nipman Foundation and the India Autism Center, in collaboration with the Department of Empowerment of Persons with Disabilities (DEPwD), Government of India, have formally launched the Breaking Barriers Fellowship 2026, with the support of the United Nations in India. The Breaking Barriers Fellowship is a first-of-its-kind national initiative designed to bring exceptional young professionals into institutions under DEPwD to support policy processes and advance the implementation of the Rights of Persons with Disabilities (RPwD) Act, 2016. Speaking at the launch, Rohit Kumar, Co-founder, YLAC, highlighted the role of young people in strengthening public systems, noting that “When you give young people platforms, it breaks cynicism and helps them move into policy spaces and create change.” As India continues to strengthen its disability rights and governance framework, there is growing emphasis on sustained policy support, research inputs, and coordination to complement the work of public institutions. The Fellowship has been designed to provide such support while also building a pipeline of young professionals with practical exposure to disability governance and public systems. Placement institutions include the Department of Empowerment of Persons with Disabilities (DEPwD), the Office of the Chief Commissioner for Persons with Disabilities (CCPD), the National Trust, the Rehabilitation Council of India (RCI), Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (PDUNIPPD), the National Institute for the Empowerment of Persons with Visual Disabilities (NIEPVD), the Ali Yavar Jung National Institute of Speech and Hearing Disabilities (AYJNISHD), and the National Institute for the Empowerment of Persons with Intellectual Disabilities (NIEPID).   ]]> https://biospectrumindia.com/news/22/27133/birac-inks-letter-of-intent-with-global-antibiotic-research-development-partnership.html https://biospectrumindia.com/news/22/27133/birac-inks-letter-of-intent-with-global-antibiotic-research-development-partnership.html Tue, 30 Dec 2025 00:00:00 +0530 Biotechnology Industry Research Assistance Council (BIRAC) has announced a Letter of Intent (LoI) with the Global Antibiotic Research & Development Partnership (GARDP). The collaboration focuses to advance knowledge sharing and capacity building in antibiotic R&D and tech transfer through case studies, CMC support, training, and joint outreach initiatives in India and globally.At the BIRAC–GARDP LoI announcement, Dr Jitendra Kumar, MD, BIRAC, underscored the significance of this collaboration in strengthening CMC technical support, capacity building, and joint educational and outreach initiatives in antibiotic R&D. He also engaged with GARDP on initiating collaborative activities. ]]> https://biospectrumindia.com/news/22/27132/st-minister-dr-jitendra-singh-inaugurates-biotechnology-research-and-innovation-council-bric-secretariat-.html https://biospectrumindia.com/news/22/27132/st-minister-dr-jitendra-singh-inaugurates-biotechnology-research-and-innovation-council-bric-secretariat-.html Mon, 29 Dec 2025 00:00:00 +0530 Union Minister of State (Independent Charge) for Science and Technology (S&T) Dr Jitendra Singh formally inaugurated the Biotechnology Research and Innovation Council (BRIC) Secretariat, on 29 December, by unveiling the inaugural curtain, marking the official opening of a new milestone in India’s biotechnology journey. This inauguration reflects the Government of India’s strong vision to accelerate innovation, empower researchers, strengthen institutional capacity, and enhance the nation’s global leadership in biotechnology. With the launch of the BRIC Secretariat, BRIC-DBT is poised to further advance cutting-edge research, promote translational science, foster collaboration, and enable impactful solutions that contribute to India’s development and societal well-being. As part of the inauguration of the BRIC Secretariat, Dr Jitendra Singh reviewed key initiatives, ongoing programmes, and future pathways to strengthen India’s biotechnology landscape. BRIC DBT (Biotechnology Research and Innovation Council – Department of Biotechnology) is a premier organisation dedicated to advancing biotechnology research and innovation across India. With 13 affiliated institutes, it drives groundbreaking research in healthcare, agriculture, environmental sustainability, and industrial biotechnology. ]]> https://biospectrumindia.com/news/22/27097/pm-modi-launches-ayush-mark-setting-global-quality-benchmarks-for-indias-traditional-medicine.html https://biospectrumindia.com/news/22/27097/pm-modi-launches-ayush-mark-setting-global-quality-benchmarks-for-indias-traditional-medicine.html Fri, 19 Dec 2025 00:00:00 +0530 In a historic and visionary move that marks a defining moment for India’s traditional medicine ecosystem, Prime Minister (PM) Narendra Modi launched the Ayush Mark in New Delhi, establishing a globally aligned quality certification framework for Ayush products and services. The launch, held on the national stage, reinforces India’s resolve to position its ancient systems of medicine—Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy—as trusted, science-backed, and internationally credible healthcare solutions. Industry leaders across the country hailed the Ayush Mark as a transformational reform that will reshape the future of the Ayush sector, strengthen global trust, and unlock new export opportunities. The Ayush Mark has been conceptualised as a gold standard of quality, safety, and compliance, aligned with global regulatory benchmarks and WHO-recommended practices. With two levels of certification, the Ayush Standard Mark for domestic assurance and the Ayush Premium Mark for international markets, the initiative addresses long-standing challenges of quality perception, regulatory acceptance, and consumer confidence. Experts believe this move will significantly accelerate India’s leadership in the global traditional medicine market, where demand for certified, natural, and holistic healthcare solutions is rising sharply. From the government’s perspective, the Ayush Mark is being viewed as a strategic instrument to enhance India’s global credibility. Officials from the Ministry noted that the Ayush Mark complements several other reforms, including digital certification platforms, international cooperation agreements, and research-driven validation of traditional therapies. Together, these initiatives are expected to drive export growth, create employment, and strengthen India’s soft power in global healthcare diplomacy. Industry analysts believe the launch of the Ayush Mark comes at a critical juncture, as global consumers increasingly seek natural, preventive, and holistic healthcare options backed by scientific validation. With structured quality certification now in place, Indian Ayush products are expected to gain smoother regulatory access and stronger market acceptance in regions such as Europe, North America, Southeast Asia, and the Middle East. ]]> https://biospectrumindia.com/news/22/27011/pharmacopoeia-commission-of-india-inks-three-mous-with-nagaland-government.html https://biospectrumindia.com/news/22/27011/pharmacopoeia-commission-of-india-inks-three-mous-with-nagaland-government.html Fri, 28 Nov 2025 00:00:00 +0530 The Pharmacopoeia Commission of India (IPC), Ghaziabad, an autonomous institute under the Ministry of Health and Family Welfare, Government of India, has signed three Memorandums of Understanding (MoUs) with Nagaland Medical Council, Nagaland State Drug Control Administration (NSDCA), Department of Health and Family Welfare, Nagaland and State Pharmacy Council, Government of Nagaland. The MoU was signed during a one-day training programme on monitoring in the pharma and materials sector. It was organised by the Pharmacopoeia Commission of India, Ghaziabad in collaboration with the Nagaland State Drug Control Administration (NSDCA), Department of Health and Family Welfare, Nagaland. The event aimed to strengthen IPC's collaborative efforts in promoting public health by facilitating the use of Indian Pharmacopoeia reference substances and impurity standards in drug testing laboratories under NSDCA, safe and rational use of drugs, enhancing surveillance activities in the pharma and ingredients sector, and advancing patient safety initiatives in the state of Nagaland. This MoU is expected to enhance professional engagement, establish adverse drug reaction (ADR) Monitoring Centres/Medical Devices Monitoring Centres/Monitoring Centres. It is expected to encourage wider participation in ADR reporting through establishment of Medical Device Monitoring Centres and strengthen the drug safety monitoring mechanism in the sector. IPC is committed to provide all possible technical guidance and expert support for these initiatives. NSDCA and Nagaland State Pharmacy Council are also expected to cooperate with the Government of India to facilitate the establishment of Medical Colleges/Pharmacies in the country.  ]]> https://biospectrumindia.com/news/22/26990/govt-strengthens-research-driven-innovation-in-ayurveda-pharma-sector-with-siddhi-2-0.html https://biospectrumindia.com/news/22/26990/govt-strengthens-research-driven-innovation-in-ayurveda-pharma-sector-with-siddhi-2-0.html Wed, 26 Nov 2025 00:00:00 +0530 The Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of Ayush, Government of India, has launched the second edition of its flagship industry–research interface initiative, SIDDHI 2.0 (Scientific Innovation in Drug Development, Healthcare & Integration), in Vijayawada. The two-day national conclave has been organised by the Regional Ayurveda Research Institute (RARI), Vijayawada, in collaboration with the Confederation of Indian Industry (CII), Vijayawada Zone. Building on the momentum created by PRAGATI-2024 (Pharma Research in Ayurgan and Techno-Innovation), SIDDHI 2.0 marks a strategic shift towards research-led product development, indigenous technology advancement, accelerated translational pathways, and industry partnerships—key elements of India’s evolving Ayush innovation agenda. K. Dinesh Kumar, IAS, Director (Ayush), Government of Andhra Pradesh, noted that the number of Ayurveda colleges and pharmaceutical units in the State remains limited and proposed the establishment of a National Ayurveda Institute. He emphasised that SIDDHI 2.0 brings all key stakeholders onto a single platform and added that while modern science has increased lifespan, Ayurveda can ensure a healthier lifespan. ]]> https://biospectrumindia.com/news/22/26981/csir-and-icmr-hold-meeting-to-chart-joint-health-research-roadmap.html https://biospectrumindia.com/news/22/26981/csir-and-icmr-hold-meeting-to-chart-joint-health-research-roadmap.html Tue, 25 Nov 2025 00:00:00 +0530 The Council of Scientific and Industrial Research (CSIR) and the Indian Council of Medical Research (ICMR) convened a high-level Brainstorming Meeting at the CSIR Science Centre, New Delhi, to strengthen ongoing collaborations and outline a forward-looking, integrated roadmap for joint health research. The meeting was co-chaired by Dr N. Kalaiselvi, Director General, CSIR and Secretary, DSIR, and Dr Rajiv Bahl, Director General, ICMR and Secretary, Department of Health Research. Directors of several CSIR and ICMR laboratories, along with senior officials from both organisations, participated in the discussions. During the deliberations, the two organisations reviewed the progress of major ongoing collaborative initiatives, including CSIR molecules moving into clinical trials, the status of ICMR-supported Centres of Advanced Research in CSIR laboratories, and the implementation of big-ticket projects. The need to continue and expand wastewater surveillance for multiple pathogens across cities, hospitals, and communities was highlighted, with a consensus to strengthen joint efforts through the One Health Mission. Both sides also discussed the respective roles and responsibilities of CSIR and ICMR in the development of novel molecules and drugs, including systematic clinical trials and the use of ICMR’s large-animal toxicity testing facilities. The AcSIR–ICMR Ph.D. programme was reviewed, with an emphasis on expanding opportunities for young researchers, including the integration of ICMR fellowships alongside CSIR fellowships. The meeting concluded with a shared commitment to intensify collaboration, streamline joint project development, and expand engagement across emerging domains such as biomedical science, diagnostics, digital health, and environmental health surveillance. ]]> https://biospectrumindia.com/news/22/26937/eli-lillys-donanemab-receives-cdsco-nod-for-treatment-of-early-symptomatic-alzheimers-disease.html https://biospectrumindia.com/news/22/26937/eli-lillys-donanemab-receives-cdsco-nod-for-treatment-of-early-symptomatic-alzheimers-disease.html Tue, 18 Nov 2025 00:00:00 +0530 Eli Lilly and Company (India) has announced that the Central Drugs Standard Control Organization (CDSCO) has granted marketing authorisation for donanemab (350 mg/20 mL administered every four weeks via intravenous infusion as described in the prescribing information) for the treatment of Alzheimer’s disease (AD) in adults with early symptomatic stages. This includes individuals with mild cognitive impairment (MCI) and those in the mild dementia stage of AD, with confirmed amyloid pathology. Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer’s disease. Donanemab is a disease modifying drug that helps the body remove excessive buildup of amyloid plaques and slows the cognitive and functional decline that may diminish people’s ability to remember new information, important dates, and appointments; plan and organize; make meals; use household appliances; manage finances; and be left alone. Alzheimer’s disease is the most common cause of dementia globally, accounting for 60–70% of cases. However, currently, it is highly underdiagnosed. India, with its rapidly ageing population, faces a growing health challenge: it is estimated that by 2030, over 8 million people in India will be living with dementia, with Alzheimer’s disease representing the largest share of cases. Early diagnosis and treatment are critical to improving patient outcomes and easing the significant burden on families and caregivers. ]]> https://biospectrumindia.com/news/22/26943/health-minister-announces-national-action-plan-on-antimicrobial-resistance-2-0.html https://biospectrumindia.com/news/22/26943/health-minister-announces-national-action-plan-on-antimicrobial-resistance-2-0.html Tue, 18 Nov 2025 00:00:00 +0530 Union Minister of Health and Family Welfare, Jagat Prakash Nadda, has launched the second version of the National Action Plan (NAP) on Antimicrobial Resistance (2025–29). He was joined by Dr A K Sood, Principal Scientific Advisor; Smt. Punya Salila Srivastava, Union Health Secretary; Dr Rajiv Bahl, Secretary, Dept. of Health Research and Dr Sunita Sharma, Director General of Health Services (DGHS). NAP-AMR 2.0 addresses the gaps identified in the first NAP-AMR by increasing the ownership of AMR-related efforts, strengthening inter-sectoral coordination and ensuring stronger engagement with the private sector. Asserting on the key strategies of AMR containment which are to be implemented under NAP AMR 2.0, the Minister stated the importance of increasing awareness, education and training. He also highlighted the requirement of enhancing laboratory capacity and infection control in healthcare facilities. Nadda stressed on the importance of regular stakeholder meetings to resolve challenges promptly. Dr A K Sood stated that the NAP-AMR 2.0 is timely initiative for generating a more coherent action plan which is aptly being released on the first day of the WHO’s World AMR Awareness Week (18-24 Nov). Noting that India is one of the pioneers in driving this initiative globally, he stated that AMR is a like a pandemic affecting many countries especially the developing countries in Asia and Africa. Dr Sood highlighted some of the steps taken by India in countering the menace of AMR. He pointed out that Kerala and Gujarat are the first states to ban over-the-counter sales of antibiotics. Some antimicrobials and pesticides have also been banned for use in crops. ]]> https://biospectrumindia.com/news/22/26930/indian-pharmacopoeia-commission-signs-mou-with-jharkhand-state-pharmacy-council.html https://biospectrumindia.com/news/22/26930/indian-pharmacopoeia-commission-signs-mou-with-jharkhand-state-pharmacy-council.html Sat, 15 Nov 2025 00:00:00 +0530 The Indian Pharmacopoeia Commission (IPC), Ghaziabad, an autonomous institution under the Ministry of Health and Family Welfare, Government of India, has signed a Memorandum of Understanding (MoU) with the Jharkhand State Pharmacy Council (JSPC), to strengthen collaborative efforts aimed at promoting the safe and rational use of medicines, enhancing pharmacovigilance and materiovigilance activities, and advancing patient safety initiatives across the state of Jharkhand. The MoU was signed by Dr V. Kalaiselvan, Secretary-cum-Scientific Director, IPC, and Prasanth Kumar Pandey, Registrar-cum-Secretary, JSPC, in the presence of representatives from both organisations. Through this collaboration, IPC and JSPC will work together to build the capacity of registered pharmacists in areas related to adverse drug reaction (ADR) reporting, pharmacovigilance and materiovigilance practices, and the safe use of medicines. The partnership envisions strengthening the utilization of the National Formulary of India (NFI) as a standard reference document across healthcare facilities in Jharkhand and promoting its systematic use by pharmacists to support rational dispensing and safe medication practices. It further includes coordinated efforts to organise awareness programmes for hospital and community pharmacists, support the mandatory use of the NFI in institutional pharmacy settings, and facilitate annual observance of the National Pharmacovigilance Week in collaboration with IPC. This MoU is expected to enhance professional engagement, encourage wider participation in ADR reporting, and reinforce medicine safety surveillance mechanisms in the state. IPC will provide technical guidance and expert support for these initiatives, while JSPC will coordinate with pharmacists in public and private healthcare establishments to ensure effective implementation of the agreed activities. ]]> https://biospectrumindia.com/news/22/26904/govt-launches-bricbirac-entrepreneur-in-residence-eir-programme.html https://biospectrumindia.com/news/22/26904/govt-launches-bricbirac-entrepreneur-in-residence-eir-programme.html Tue, 11 Nov 2025 00:00:00 +0530 Speaking at the inauguration of NHP-ABSL-3 Facility while delivering the inaugural address at the Second Foundation Day Celebration of "Biotechnology Research & Innovation Council" (BRIC) held at BRIC–National Institute of Immunology (NII), Union Minister of State (Independent Charge) for Science & Technology; Dr Jitendra Singh observed that India is already initiated into next industrial revolution driven by biotechnology . The Minister noted that India is one of the few countries to have an exclusive dedicated Biotechnology policy BiOE3. He commended the Department of Biotechnology (DBT) for emerging as one of the most dynamic and integrated scientific ecosystems in the Government of India. Additionally, Dr Jitendra Singh launched BRIC–BIRAC Entrepreneur-in-Residence (EIR) Programme. The Union Minister recalled that under the visionary leadership of Prime Minister Narendra Modi, the decision to merge 14 autonomous biotechnology institutions under a single umbrella—BRIC, was a transformative reform that strengthened coordination, innovation, and impact across India’s biotechnology sector. He also announced the establishment of the BRIC Bio-Enterprise Innovation Park on a 200-acre campus in Faridabad to promote innovation-led entrepreneurship. In his address, Dr Rajesh S. Gokhale, Secretary, DBT and DG, BRIC, highlighted the achievements of BRIC institutions over the past three years — 3,190 publications, 107 patents, 13 technologies commercialized, 2,578 PhD scholars, and 678 post-doctoral fellows currently contributing to the research network. He also noted that BRIC ranks number one in biological sciences in India, as per Nature’s Pringles Index. ]]> https://biospectrumindia.com/news/22/26905/health-ministry-announces-simplification-in-corneal-transplantation-rules.html https://biospectrumindia.com/news/22/26905/health-ministry-announces-simplification-in-corneal-transplantation-rules.html Tue, 11 Nov 2025 00:00:00 +0530 The Ministry of Health and Family Welfare in alignment with  the Government’s vision to promote equitable access to organ and tissue transplantation services has notified the Transplantation of Human Organs and Tissues (Amendment) Rules, 2025 under the Transplantation of Human Organs and Tissues Act, 1994 on 6th November, 2025. This amendment which further strengthens the National Organ Transplant Programme (NOTP), aims to streamline the functioning of corneal transplantation centres and facilitate wider accessibility to eye donation and transplantation services across the country. The mandatory requirement of the Clinical Specular equipment in Corneal Transplantation Centres has now been removed under this amendment. This change has been introduced after careful consideration of expert recommendations and stakeholder consultations. The amendment is expected to ease infrastructural and operational challenges, particularly for smaller eye centers in rural and semi-urban areas, thereby enhancing the overall availability and accessibility to the corneal transplantation services in the country. This progressive amendment will serve as a long-term measure to strengthen the country’s cornea donation and transplantation ecosystem. ]]> https://biospectrumindia.com/news/22/26906/nha-renews-mou-with-dhr-and-icmr-to-strengthen-evidence-based-healthcare-decision-making.html https://biospectrumindia.com/news/22/26906/nha-renews-mou-with-dhr-and-icmr-to-strengthen-evidence-based-healthcare-decision-making.html Tue, 11 Nov 2025 00:00:00 +0530 The National Health Authority (NHA), the implementing agency of Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) and the Ayushman Bharat Digital Mission (ABDM), has renewed its Memorandum of Understanding (MoU) with the Department of Health Research (DHR) and the Indian Council of Medical Research (ICMR). The renewed collaboration aims to further strengthen technical cooperation for evidence-based decision-making to optimise healthcare resource allocation and enhance quality across India’s flagship health schemes. The MoU was formally signed by Dr Sunil Kumar Barnwal, CEO, National Health Authority, and Dr Rajiv Bahl, Secretary, Department of Health Research and Director General, ICMR. The renewed agreement will extend the collaboration to the Ayushman Bharat Digital Mission (ABDM). Under this, DHR and ICMR, through the Health Technology Assessment India (HTAIn) initiative, will provide data-driven insights to evaluate digital health interventions—including electronic health records (EHRs), telemedicine platforms, and AI-based diagnostics—to ensure their affordability, efficiency, and sustainability within the ABDM ecosystem. ]]> https://biospectrumindia.com/news/22/26879/karnataka-unveils-rs-600-cr-deep-tech-decade-initiative.html https://biospectrumindia.com/news/22/26879/karnataka-unveils-rs-600-cr-deep-tech-decade-initiative.html Tue, 04 Nov 2025 00:00:00 +0530 The Government of Karnataka has announced an investment of over Rs 600 crore to power the state’s “Deep Tech Decade,” with the goal of establishing Karnataka as the Deep Tech Capital of India. Priyank Kharge, Minister for IT & BT, Government of Karnataka announcing this emphasised that the initiative aims to build a robust pipeline of entrepreneurs and innovators working in cutting-edge fields such as artificial intelligence (AI), machine learning (ML), quantum computing, advanced manufacturing, robotics, and sustainability-driven technologies. As part of this vision, the government is also in talks with leading venture capital firms to create a joint Deep Tech and AI fund of up to Rs 1,000 crore to support startups in the sector. The Rs 600 crore investment includes Rs 150 crore for the Deep Tech Elevate Fund, focusing on AI and frontier technologies; Rs 80 crore under the Elevate Beyond Bengaluru Fund to promote startups in Mysuru, Mangaluru, Hubballi-Dharwad, and Kalaburagi; Rs 75 crore through the KITVEN Fund for equity investments ranging between Rs 50 lakh and Rs 2 crore in Deep Tech and AI startups; and Rs 48 crore for establishing new incubators and accelerators at IIT Dharwad, IIIT Dharwad, and Kalaburagi. In addition, Rs 110 crore will be allocated for business incubators in higher education institutions, supporting early-stage innovation and entrepreneurship across 11 institutions already approved by the state cabinet. The government has further earmarked Rs 200 crore specifically for Deep Tech startups and plans to explore fund-of-funds and co-investment models in collaboration with venture capital ecosystems to ensure steady capital flow and scalability across the Deep Tech value chain. Dr Manjula N, Secretary, Department of Electronics, IT, Bt & S&T; and Rahul Sankanur, Director, Department of Electronics, IT & Bt and Managing Director, KITS were also present while Kharge made the announcements.   Photo caption: From Left to Right: Dr Manjula N., Secretary to Government, Dept. of Electronics, Information Technology, Biotechnology and Science & Technology; Priyank Kharge, Minister for Information Technology, Biotechnology and Rural Development & Panchayat Raj, Government of Karnataka; Rahul Sankanur, Director, Directorate of Electronics, Science and technology IT&Bt, MD, KITS, Govt. of Karnataka addressing the media at a press conference in Bengaluru on November 3. ]]> https://biospectrumindia.com/news/22/26832/anrf-in-collaboration-with-icmr-and-gates-foundation-launches-maha-medtech-mission.html https://biospectrumindia.com/news/22/26832/anrf-in-collaboration-with-icmr-and-gates-foundation-launches-maha-medtech-mission.html Sat, 25 Oct 2025 00:00:00 +0530 Anusandhan National Research Foundation (ANRF), in collaboration with the Indian Council of Medical Research (ICMR) and the Gates Foundation, has launched the Mission for Advancement in High-Impact Areas (MAHA)-Medical Technology (महा MedTech). This landmark initiative aims to accelerate innovation in India’s medical technology sector, reduce reliance on high-cost imports, and promote equitable access to affordable and high-quality medical technologies. The Mission will provide funding support to a wide range of entities including Academic and R&D institutions, Hospitals, Startups, MSMEs, MedTech industry and collaborations between entities. With milestone-linked funding of Rs 5–25 crore per project (and up to Rs 50 crore in exceptional cases), the Mission will support projects that bring impactful MedTech solutions to market. Key objectives Drive public health impact by supporting technologies that address priority disease areas and expand access to safe, high-quality care; Ensure affordability and accessibility by supporting solutions that reduce costs; and Enhance self-reliance and competitiveness by catalyzing indigenous MedTech development, manufacturing, and industry–academia collaboration. Scope of the Mission The scheme will cover a broad spectrum of innovative medical devices and in-vitro diagnostics, including equipment and key subcomponents, implants, assistive and surgical devices, consumables, and software-based medical solutions. This may include (but is not limited to) advanced diagnostic imaging, minimally invasive technologies, point of care molecular diagnostics, AI/ML-enabled platforms, robotics and other emerging areas. The mission welcomes projects aligned with national health priorities such as tuberculosis, cancer, neonatal care, primary health care, etc. In addition to funding, the Mission will provide enabling support through national initiatives such as Patent Mitra (IP protection and technology transfer), MedTech Mitra (regulatory guidance and clearances), a Clinical Trial Network (for clinical validation and evidence generation), as well as mentorship from industry experts. The Mission will follow a two-stage application process: Concept Notes: Open from 15 September to 7 November 2025, to screen and prioritize projects. Applications will be accepted through the ANRF portal: www.anrfonline.in Full Proposals: The concept proposals that are shortlisted by the committee formed specifically for this purpose will be allowed to submit the full proposals. The window for submission will open in December 2025. ]]> https://biospectrumindia.com/news/22/26826/govt-launches-training-modules-on-public-health-management-of-chemical-emergencies.html https://biospectrumindia.com/news/22/26826/govt-launches-training-modules-on-public-health-management-of-chemical-emergencies.html Thu, 23 Oct 2025 00:00:00 +0530 Chemical emergencies pose a significant and evolving threat to public health, environmental safety, and societal stability, underscoring the need for strengthened national preparedness and response mechanisms. In the present fast growing Industrial economy, updating and keeping oneself prepared for any such emergencies is of paramount importance. As a step towards enhanced preparedness, the Secretary of Health and Family Welfare, along with key senior officials from various line ministries, national agencies, experts from private sector, industry and academia released the modules on Public Health Management of Chemical Emergencies at Nirman Bhawan, New Delhi. Three specialised training modules have been developed by the National Centre for Disease Control (NCDC), Ministry of Health and Family Welfare (MoHFW), Government of India, on the Public Health Management of Chemical Emergencies in collaboration with NDMA (National Disaster Management Authority) and with technical support from World Health Organization (WHO India). The three modules include: •  Module 1: Preparedness, Surveillance, and Response for Public Health Managementof Chemical Emergencies •  Module 2: Pre-Hospital Management of Chemical Emergencies •  Module 3: Medical Management of Chemical Emergencies These modules aim to equip public health professionals, healthcare workers, emergency responders, and policymakers with the necessary knowledge, skills, and operational tools for timely and effective management of chemical incidents. Strengthening chemical emergency management also supports core capacities under the International Health Regulations (IHR 2005), contributing to both national and global health security. ]]> https://biospectrumindia.com/news/22/26828/telangana-targets-rs-1-lakh-crore-investments-in-life-sciences-by-2030.html https://biospectrumindia.com/news/22/26828/telangana-targets-rs-1-lakh-crore-investments-in-life-sciences-by-2030.html Thu, 23 Oct 2025 00:00:00 +0530 Telangana has set an ambitious target of attracting Rs 1 lakh crore in new investments in the Life Sciences sector by 2030, aiming to generate employment for five lakh people, said Minister for IT and Industries Duddilla Sridhar Babu. Delivering the keynote address at the AusBiotech International Conference 2025 in Melbourne (being held from 21 to 24 October 2025) — organised jointly by AusBiotech and the Government of Victoria - the Minister said the State government has drawn up a comprehensive “Roadmap 2030” to position Telangana as a Global Life Sciences Hub. “Telangana is preparing a Comprehensive Life Sciences Policy to accelerate innovation, infrastructure, and global partnerships,” Sridhar Babu said, outlining the State’s strategy for the next phase of bio-digital growth. The Minister said Telangana continues to outperform national averages in economic growth. Though the State ranks 11th in geographical area and 12th in population, it contributes over 5% to India’s GDP. Telangana’s GSDP growth rate in 2024–25 stood at 8.2%, compared with the national average of 7.6%, he noted. Over the past 20 months, the State has attracted Rs 3.2 lakh crore in new investments, with Rs 63,000 crore coming from the Life Sciences sector alone. Exports from the sector crossed Rs 26,000 crore between April and December 2024. The State aims to increase the value of the Life Sciences economy from $80 billion to $250 billion by 2030, the Minister said. Citing a report by global consultancy CBRE, Sridhar Babu said Hyderabad has been featured in the Global Life Sciences Atlas 2025 among the world’s leading Life Sciences clusters — alongside Boston, San Francisco, Cambridge, Beijing, and Tokyo. Hyderabad is the only Indian city to feature in this list, he added. Life Sciences office leasing in the city expanded from 0.6 million sq. ft. in 2022 to 2.4 million sq. ft. in 2024, reflecting the sector’s rapid growth and investor confidence.   Sridhar Babu invited Australian companies to explore investment opportunities in emerging and high-growth areas such as Cell and Gene Therapy, Biologics and Biosimilars, mRNA Vaccines, Contract Research, Development and Manufacturing (CRDM), Diagnostics, MedTech, and Digital Health. He also highlighted Telangana’s focus on AI-based Drug Discovery, Genomics, Green Biomanufacturing, Agri-Biotech, and Animal Health, saying these sectors offer immense potential for collaboration and value creation.  ]]> https://biospectrumindia.com/news/22/26754/dbt-inks-pact-with-uttar-pradesh-to-boost-biotech-pharma-and-medtech-innovation.html https://biospectrumindia.com/news/22/26754/dbt-inks-pact-with-uttar-pradesh-to-boost-biotech-pharma-and-medtech-innovation.html Tue, 30 Sep 2025 00:00:00 +0530 An official Memorandum of Understanding (MoU) has been signed between the Department of Biotechnology (DBT), Govt of India and the Government of Uttar Pradesh. The agreement, executed through DBT’s Biotechnology Industry Research Assistance Council (BIRAC) and the Uttar Pradesh Promote Pharma Council (UPPPC) is part of a centre–state partnership model to accelerate innovation, entrepreneurship, and investment in the pharma, biotech, and medtech sectors. Currently there are around 800 Medical Device manufacturers in the country and India's annual growth of the medtech sector is 15 to 20%, said Dr Jitendra Singh, Union Minister of State (Independent Charge) for Science and Technology. Officials said the collaboration will focus on advancing research and innovation, building a stronger ecosystem for startups, enhancing skill development and knowledge exchange, fostering closer industry linkages with SMEs and MSMEs, and catalysing greater investment in the sector. DBT Secretary and BIRAC Chairman Dr Rajesh S. Gokhale said the agreement with Uttar Pradesh would “unlock innovation pipelines and scale up affordable technologies.” Senior state government officials underlined their commitment to positioning the state as a hub for pharma, biotech, and medtech, pointing to projects such as the Biotech Park in Lucknow, the Medical Device Park in Greater Noida, and the Bulk Drug & Pharma Park in Lalitpur. ]]> https://biospectrumindia.com/news/22/26730/ministry-of-ayush-signs-agreement-with-who-to-co-host-2nd-global-summit-on-traditional-medicine-in-new-delhi.html https://biospectrumindia.com/news/22/26730/ministry-of-ayush-signs-agreement-with-who-to-co-host-2nd-global-summit-on-traditional-medicine-in-new-delhi.html Thu, 25 Sep 2025 00:00:00 +0530 The Ministry of Ayush, Government of India has signed an agreement with the World Health Organization (WHO) to co-host the 2nd WHO Global Summit on Traditional Medicine on the theme “Restoring balance for people and planet: The science and practice of well-being”. The Summit will be held in New Delhi from 17th to 19th December 2025. The agreement signing took place in the presence of Union Minister of State for Ayush (IC), Prataprao Jadhav, and Secretary, Ministry of Ayush, during the 2nd Summit Planning Group Meeting convened to monitor activities and progress for the upcoming Summit. The Global Summit will serve as an important international platform bringing together experts, policymakers, and stakeholders to advance the role of traditional medicine in global health and sustainable development. The Ministry of Ayush, in partnership with WHO, reaffirmed its commitment to fostering evidence-based traditional medicine practices that contribute to human and planetary well-being. ]]> https://biospectrumindia.com/news/22/26723/cabinet-approves-dsir-scheme-of-capacity-building-and-human-resource-development-with-outlay-of-rs-2277-4-cr.html https://biospectrumindia.com/news/22/26723/cabinet-approves-dsir-scheme-of-capacity-building-and-human-resource-development-with-outlay-of-rs-2277-4-cr.html Wed, 24 Sep 2025 00:00:00 +0530 The Cabinet, chaired by the Prime Minister Narendra Modi, has approved the Department of Scientific and Industrial Research / Council of Scientific and Industrial Research (DSIR/CSIR) Scheme on “Capacity Building and Human Resource Development” with a total outlay of Rs 2277.397 crore for the period of the Fifteenth Finance Commission Cycle 2021-22 to 2025-26. The scheme is implemented by the CSIR and will cover all R&D institutions, national laboratories, Institutes of National Importance, Institutes of Eminence, and Universities across the country. The initiative provides a wide platform for young, enthusiastic researchers aspiring to build careers in universities, industry, national R&D laboratories, and academic institutions. Guided by eminent scientists and professors, the scheme will foster growth in Science, Technology & Engineering, Medical, and Mathematical Sciences (STEMM). The Capacity Building and Human Resource Development Scheme plays an important role in the achievement of the Sustainable Development Goals (SDGs) for the science and technology (S&T) sector in India by increasing the researchers per million population. The Scheme has demonstrated its relevance by building capacity and expanding the pool of high-quality human resources in the S&T sector. Concerted efforts put in Research and Development (R&D) in Science and Technology by the Government of India during last decade, India has improved its position in the Global Innovation Index (GII) to 39th rank in 2024 as per the World Intellectual Property Organisation (WIPO) ranking which will further improve in near future under the visionary guidance of the Prime Minister of India. ]]> https://biospectrumindia.com/news/22/26724/dmma-warns-regulatory-burden-threatening-gujarats-pharma-msmes.html https://biospectrumindia.com/news/22/26724/dmma-warns-regulatory-burden-threatening-gujarats-pharma-msmes.html Wed, 24 Sep 2025 00:00:00 +0530 The Drug Marketing and Manufacturing Association (DMMA) has warned that the growing regulatory burden could force widespread closure of small and medium-sized pharmaceutical units in Gujarat and sought urgent government intervention to safeguard the industry. The association has warned that the shutdown of units would have a huge impact on pharma exports and trigger job losses. Over 30 pharma associations (DMMA, Federation of Pharma Entrepreneurs, Laghu Udyog Bharti, state associations from Himachal (HDMA), Haryana, Karnataka, etc.) have jointly appealed to Union Health Minister JP Nadda and Central Drugs Standard Control Organisation (CDSCO), and submitted a detailed representation outlining the challenges specially withdrawal of the recent directive enforcing bio-equivalence studies under GSR 327 (E). Each BA/BE study costs Rs 20–40 lakh per product, and MSMEs may have dozens of formulations. This makes compliance financially unviable, saying the lack of officially notified reference products, the high cost of studies, and ethical concerns make compliance impractical and impossible for small units to absorb. Without urgent relief, thousands of units will collapse, leading to medicine shortages nationwide.  The association called for an end to the constant issuance of regulatory circulars that make operations unpredictable and capital-intensive. The association raised alarm over the Revised Schedule M (Good Manufacturing Practices) requirements, slated to come into effect from January 1, 2026. It warned that the expanded scope and costly upgrades, notified without accommodating the objections of the MSME sector, could force 4,000–5,000 units to close. It demanded that the deadline for companies have a turnover of less than Rs 50 crores should be extended till April 2027. DMMA objected to risk-based inspections that selectively target MSME units while sparing large corporates, and to the practice of shutting down plants merely based on a manufacturer's own corrective action report if no critical lapses are found. DMMA President Amit Thakkar said, "Micro, small, and medium enterprises (MSMEs) are the backbone of India's pharmaceutical industry, but they are being burdened by an endless stream of regulatory circulars that run counter to the government's own Ease of Doing Business agenda. While MSME manufacturers will be hit the hardest, these measures will also create shortages of affordable medicines and erode our export competitiveness, allowing other countries to overtake India in global markets."   ]]> https://biospectrumindia.com/news/22/26641/govt-recommends-gst-reduction-from-12-to-5-on-various-medical-equipment-and-supplies-devices.html https://biospectrumindia.com/news/22/26641/govt-recommends-gst-reduction-from-12-to-5-on-various-medical-equipment-and-supplies-devices.html Thu, 04 Sep 2025 00:00:00 +0530 The 56th meeting of the GST Council was held in New Delhi under the chairpersonship of the Union Finance & Corporate Affairs Minister Nirmala Sitharaman. The GST Council inter-alia made the recommendations relating to changes in GST tax rates, provide relief to individuals, common man, aspirational middle class and measures for facilitation of trade in GST. Particularly for the life sciences sector, the recommendations include- Reduction of GST from 12% to NIL on 33 life-saving drugs and medicines and from 5% to NIL on 3 life-saving drugs & medicines used for treatment of cancer, rare diseases and other severe chronic diseases Reduction of GST on all other drugs and medicines from 12% to 5% Reduction of GST from 18% to 5% on various medical apparatus and devices used for medical, surgical, dental or veterinary usage or for physical or chemical analysis Reduction of GST from 12% to 5% on various medical equipment and supplies devices such as wadding gauze, bandages, diagnostic kits and reagents, blood glucose monitoring system (Glucometer) medical devices, etc Post these recommendations, encouraging responses are pouring in from the industry- Dr GSK Velu, Chairman & Managing Director, Trivitron Healthcare, Neuberg Diagnostics and Maxivision Super Speciality Eye Hospitals said, “These new GST reforms are path breaking and should overall boost our economy and benefit every citizen of India. We welcome the decision to reduce GST from 12 % to 5% for medical devices, diagnostics instruments and reagents. We also welcome the nil GST on medical insurance, general insurance and few lifesaving drugs. Also if the well intended reforms on GST reforms and resolution to inverted duty structure is well implemented it will benefit all industries and will ensure desired benefit reaches end consumers." Dr Harsh Mahajan FICCI Chairman- Health & Services & Founder Mahajan Imaging & Labs said, "We are also hopeful that GST on equipment maintenance service contracts will also be brought down from 18% to 5%, in line with rate rationalisation and the fact that hospitals and diagnostic centres  do not get any input tax credit on GST that they pay on essential items like equipment, lease rentals, equipment service contracts, etc which is 4-5% of total revenue leading to  "embedded taxes" and higher patient costs." According to Sheetal Arora, Promoter & CEO, Mankind Pharma, “The GST revisions go beyond tax rationalization, they represent a structural shift in how India is enabling healthcare access. By removing GST on lifesaving rare-disease and oncology therapies and reducing it on essential medicines and diagnostics, the government has signaled that affordability and innovation can go hand in hand. Equally important is the reduction in GST on pharma manufacturing services, which will improve cost efficiencies, strengthen supply chains, and encourage deeper collaboration with MSMEs and CDMOs. Coupled with exemptions on health insurance and hospital services, these reforms address the ecosystem end-to-end including patients, providers, and manufacturers." Sanjiv Navangul, MD & CEO, Bharat Serums and Vaccines (A Mankind Group Company) said, “We are encouraged by the GST Council’s decision to eliminate GST on advanced therapies, particularly biologics for oncology and rare diseases. It is a decisive step toward improving and advancing healthcare equity in India. Such reforms impact treatment costs for patients and widen access and availability while integrating advanced care into mainstream treatment pathways."  Priyanka Chigurupati, Executive Director, Granules India said, "The GST Council’s rationalisation reflects a clear commitment  to strengthening India’s healthcare and pharmaceutical value chain. By reducing GST on all medicines, essential inputs, and contract manufacturing services, while exempting advanced therapies from tax, the government has created a framework that balances patient affordability with industry competitiveness. For a vertically integrated manufacturer like Granules, this change improves supply chain efficiencies and opens new opportunities to collaborate with technical and cost effective partners; improves speed of bringing products to the table. The reduction in job-work GST is significant for contract developers to scale faster, which in turn fuels a stronger and more resilient pharma ecosystem.”   ]]> https://biospectrumindia.com/news/22/26649/india-joins-health-ai-global-regulatory-network-to-strengthen-oversight-of-ai-in-healthcare.html https://biospectrumindia.com/news/22/26649/india-joins-health-ai-global-regulatory-network-to-strengthen-oversight-of-ai-in-healthcare.html Thu, 04 Sep 2025 00:00:00 +0530 HealthAI - The Global Agency for Responsible AI in Health, has welcomed India as a pioneer country joining the HealthAI Global Regulatory Network (GRN), a global network of health regulators dedicated to the safe and effective use of artificial intelligence (AI) in healthcare.  The agreement marks the start of a collaboration between India and HealthAI to share best practices and information aimed at accelerating global efforts for safer and more effective deployment of AI in healthcare. The Indian Council of Medical Research -National Institute for Research in Digital Health and Data Science (ICMR - NIRDHDS), and IndiaAI will work with HealthAI to, for example, share safety protocols and monitor AI performance in clinical settings, alongside fellow GRN members, such as the UK and Singapore. This is a fundamental step towards HealthAI's goal of promoting international cooperation for fair, secure and efficient AI-driven solutions in health sectors and solidifies India's position as a pioneer in the responsible application of AI in healthcare. This partnership enables India to contribute its expertise in health to global AI governance while accelerating the safe integration of AI tools across the country’s diverse healthcare landscape. With the growing advancement and use of AI in healthcare delivery, responsible AI emerges as a critical enabler to improve service efficiency and expand equitable access to quality care at scale, both nationally and globally. Members also benefit from technical support while contributing to the implementation and adoption of best practice standards for AI in Health that balance innovation with data privacy and patient safety. HealthAI intends to launch more efforts to provide support for pioneer countries, such as stakeholder engagements and the exchange of insights to help inform and refine regulatory approaches, to build a trusted and interconnected framework for the safe and effective use of AI across Asia and beyond. ]]> https://biospectrumindia.com/news/22/26635/health-ministry-to-amend-new-drugs-and-clinical-trials-rules-2019.html https://biospectrumindia.com/news/22/26635/health-ministry-to-amend-new-drugs-and-clinical-trials-rules-2019.html Wed, 03 Sep 2025 00:00:00 +0530 In accordance with the directions of Prime Minister Narendra Modi towards reducing the regulatory compliance and towards promoting ease of doing business in the pharmaceutical and clinical research sectors, the Union Health Ministry is set to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019. The proposed amendments were published in the Gazette of India on 28th August, 2025 seeking public comments. The amendments aim to simplify the requirements and procedures for obtaining test licences and for submitting applications related to Bioavailability/Bioequivalence (BA/BE) studies. Key highlights of the proposed amendments are as under: 1. Test Licence Applications: Under the proposed amendment, the present license system for test licenses has been converted to a notification/intimation system. Through this, the applicants need not wait for test licenses (except a small category of high risk category drugs) but will need to just intimate the Central Licensing Authority. Additionally, the overall statutory processing time for test licence applications will be reduced from 90 days to 45 days. 2. Bioavailability/Bioequivalence (BA/BE) Study Applications: Under the proposed amendment, the existing licence requirement will be dispensed with for certain categories of BA/BE studies, which may instead be initiated upon submission of an intimation or notification to the Central Licensing Authority. These regulatory reforms are expected to benefit stakeholders by significantly reducing the timelines for processing applications. These proposed amendments will reduce the number of license applications being submitted by approximately 50%. This will facilitate quicker initiation of BA/BE studies, testing and examination of drugs for research, and reduce delays in the drug development and approval processes. Moreover, the amendments will enable the Central Drugs Standard Control Organization (CDSCO) to optimise the deployment of its human resources, thereby enhancing the efficiency and effectiveness of regulatory oversight. ]]> https://biospectrumindia.com/news/22/26624/dbt-birac-unveils-high-performance-biomanufacturing-platforms.html https://biospectrumindia.com/news/22/26624/dbt-birac-unveils-high-performance-biomanufacturing-platforms.html Mon, 01 Sep 2025 00:00:00 +0530 The Department of Biotechnology (DBT), Government of India, and the Biotechnology Industry Research Assistance Council (BIRAC) have announced the launch of India’s first Biofoundry Network, a landmark initiative aimed at transforming the country’s biotechnology landscape and achieving a $300 billion bioeconomy by 2030. Rolled out under the BioE3 Policy (Biotechnology for Environment, Economy & Employment), the network will serve as a national platform to accelerate advanced biomanufacturing. The initiative brings together 21 cutting-edge bio-enabler facilities across India, offering shared infrastructure to start-ups, SMEs, industries, and academic institutions. These centers will support pilot and pre-commercial scale technologies across diverse sectors, including microbial biomanufacturing, sustainable agriculture, smart proteins, functional foods, precision biotherapeutics, marine biotechnology, carbon capture, and next-generation cell and gene therapies. Following are the Bio-foundries and Biomanufacturing hubs to be established by industries, incubators and academia-industry collaborations- Foundation for Science Innovation and Development (FSID), Bengaluru (with Tata Chemicals Limited ) is establishing pilot scale facility (100 L) to scale up specialty chemicals and enzymes Immunoadoptive Cell Therapy Private Limited, Mumbai is setting up GMP grade facility for gene delivery vector Hi Tech Biosciences India Ltd, Pune is setting up fermentation facility (10 KL) to produce drug intermediates Embio Ltd, Mumbai is coming up with pilot scale and large scale fermenters Laurus Bio, Visakhapatnam is establishing fermentation facility for functional foods Virchow Biotech Private Limited, Hyderabad is setting up state of the art facility for commercial production of mAbs and enzymes Agilent Bioplus LLP is setting up a plant to scale up the production of gluconates Revelations Biotech Pvt Ltd, Hyderabad is setting up QMS compliant facility for commercial production of Fructo-oligo saccharides HiMedia Laboratories, Mumbai is planning a fermentation facility at 1 KL scale for food based products Sundyota Numandis Probioceuticals Private Limited, Ahmedabad is setting up QMS compliant facility for commercial production of probiotics IIT-Madras (with TICEL Bio Park Ltd, Chennai) is setting up Facility to support development and scale up of products used in pharma & cosmetics Jindal Steel, Angul is setting up facility for sequestration of CO2 KIIT Technology Business Incubator, Bhubaneswar is planning a dedicated facility for marine biotech products. Nation’s First Animal Stem Cell repository is going to be set up by National institute of Animal Biotechnology (NIAB), Hyderabad with HiMedia Laboratories, Mumbai. Gennova Biopharmaceuticals Limited, Pune is establishing a biomanufacturing hub for mRNA-based precision medicine.   The facilities range from biofoundries working on microbial strains, smart proteins, probiotics, and bio-based chemicals to biomanufacturing hubs developing next-generation cell therapies, mRNA-based medicines, marine bio-innovations, and sustainable biofuels. Collectively, these will act as bio-enablers of innovation and commercialisation, unlocking new opportunities for industry and academia alike.   ]]> https://biospectrumindia.com/news/22/26608/govt-launches-first-national-biofoundry-network-to-strengthen-indigenous-biomanufacturing.html https://biospectrumindia.com/news/22/26608/govt-launches-first-national-biofoundry-network-to-strengthen-indigenous-biomanufacturing.html Wed, 27 Aug 2025 00:00:00 +0530 Marking one year of the BioE3 (Biotechnology for Economy, Environment and Employment) Policy, Union Minister of Science and Technology (S&T), Dr Jitendra Singh has launched the BioE3 Challenge for Youth and the country’s first National Biofoundry Network, calling it a step towards making biotechnology a driver of India’s economy, environment and employment. The Minister underscored the launch of the first National Biofoundry Network, involving six institutions (ICGEB, New Delhi; NCCS, Pune; THSTI, Faridabad; ACTREC, Mumbai; IPFT, Haryana; and NABI, Punjab) to help scale up proof-of-concept developments, enhance indigenous biomanufacturing, and create employment opportunities. The BioE3 Challenge for Youth is a nationwide call to young innovators under the theme “Design Microbes, Molecules & More”. The initiative, explained by DBT Secretary Dr Rajesh Gokhale, invites school students (Classes 6–12), university students, researchers, faculty, startups and Indian nationals to design safe-by-default biological solutions addressing challenges in health, agriculture, environment, and industry. The challenge will be announced on the first of every month beginning October 2025, with the top 10 winning solutions each receiving a cash award of Rs 1 lakh along with recognition and mentoring support. In addition, 100 selected awardees will be eligible for funding of up to Rs 25 lakh, provided in two tranches through BIRAC, to convert their ideas into proof-of-concept solutions. These projects will also gain access to facilities and incubation support at BRIC+ institutions across India. The programme aims to empower grassroots innovators, foster youth-led change, and strengthen India’s journey towards a sustainable and self-reliant bioeconomy. The BioE3 Challenge for Youth is anchored in the DESIGN framework, which guides participants to Define real needs, build Evidence-first solutions, ensure Sustainability by design, pursue Integration with other technologies and policies, develop strategies to Go-to-market, and create a Net-positive impact through measurable outcomes in jobs, inclusion, and equitable access. ]]> https://biospectrumindia.com/news/22/26548/nabl-unveils-new-medical-application-portal-for-iso-151892022-applicant-laboratories.html https://biospectrumindia.com/news/22/26548/nabl-unveils-new-medical-application-portal-for-iso-151892022-applicant-laboratories.html Tue, 19 Aug 2025 00:00:00 +0530 The National Accreditation Board for Testing and Calibration Laboratories (NABL), a constituent board of the Quality Council of India (QCI), has launched its new Medical Application Portal designed for ISO 15189:2022 applicant laboratories. The online portal was unveiled during a virtual event titled “GOING LIVE”, marking a major step in NABL’s mission to enhance ease, efficiency, and transparency in the accreditation process. The newly launched NABL Medical Application Portal has been reimagined to mirror the real-world operations of medical laboratories, offering a streamlined application process with improved user experience, reduced timelines, and greater accuracy. The portal introduces several enhancements including a restructured application flow, standardized templates, a comprehensive pre-registration checklist, an intuitive interface, and a multi-user access feature that enables laboratories to assign multiple users with distinct access rights. This is expected to accelerate data entry, enhance oversight, and ensure accountability throughout the accreditation lifecycle. Chairperson, QCI, Jaxay Shah said that with the new NABL Medical Application Portal, tasks that once took weeks or even months can now be completed within just two to three hours. He added that this marks one of the most significant disruptions in the quality ecosystem and that the same approach will now be extended to other sectors, embedding technology-driven efficiency, innovation, and responsiveness at the heart of India’s quality journey. Chairperson, NABL, Dr Sandip Shah said that the portal is a transformational step towards making the accreditation process more transparent and efficient. He added that with multi-user access and simplified features, NABL is enhancing ease of doing business for laboratories and reinforcing its commitment to India’s quality ecosystem. The initiative is expected to benefit hundreds of medical laboratories across India, providing them with an intuitive, transparent, and efficient digital platform for accreditation under ISO 15189:2022. ]]> https://biospectrumindia.com/news/22/26523/health-ministry-unveils-national-initiative-to-benchmark-and-strengthen-state-drug-regulatory-systems.html https://biospectrumindia.com/news/22/26523/health-ministry-unveils-national-initiative-to-benchmark-and-strengthen-state-drug-regulatory-systems.html Tue, 12 Aug 2025 00:00:00 +0530 Union Health Secretary, Punya Salila Srivastava virtually launched the State Health Regulatory Excellence Index (SHRESTH), a first-of-its-kind national initiative to benchmark and strengthen state drug regulatory systems through a transparent, data-driven framework in the presence of Dr Rajeev Singh Raghuvanshi, Drug Controller General of India. The initiative, proposed by the Central Drugs Standard Control Organisation (CDSCO) aims to drive improvements in the performance of state drug regulatory authorities across India, ensuring drug safety and quality standards are consistently met. The SHRESTH Index will enable targeted improvements in human resources, infrastructure, and digitisation across states, ensuring drug safety is guaranteed for every Indian, regardless of geography. It will also promote cross-learning of best practices and foster collaborative spirit. The Index, developed after detailed deliberations with the states, will regularly assess the states on several parameters such as human resources, strength of lab testing capacities, extent of digitisation of various approvals and licenses, rigour of inspection and surveillance activities, and responsiveness towards grievances received from citizens. CDSCO will facilitate sharing of success stories from top-performing states to drive collaboration and transfer of learnings. ]]> https://biospectrumindia.com/news/22/26512/karnataka-to-soon-launch-startup-policy-2025-2030.html https://biospectrumindia.com/news/22/26512/karnataka-to-soon-launch-startup-policy-2025-2030.html Mon, 11 Aug 2025 00:00:00 +0530 While the Karnataka Startup Policy 2022 remains in effect, the state government acknowledges the rapidly evolving needs of startups and the shifting dynamics of the innovation ecosystem. In response, Karnataka will be introducing a new Startup Policy to further strengthen its leadership as India’s innovation hub by supporting the creation of 25,000 new startups, including up to 10,000 emerging from clusters Beyond Bengaluru- namely Mangaluru, Mysuru, Hubballi, Kalburgi, with a focus on Deeptech, sustainability, and inclusive growth. As part of this initiative the state government is hosting Future Makers Conclave at Bengaluru Tech Summit 2025 to be held from November 18-20, 2025, where in 20,000 startup founders from across the globe will come together, to be a part of this gathering, all united by a shared purpose- shaping a conscious, connected future. This high-impact, one-day conclave brings together an extraordinary community of trailblazers- from global changemakers and entrepreneurs to spiritual leaders, engineers, adventure sportspersons and athletes, to artists, and pioneers of the impossible. The new Startup Policy adopts a lifecycle-based approach, offering tailored support from ideation to scale-up. The policy is anchored on seven strategic pillars: Funding and Grants to provide financial backing for early-stage startups, offering grants, funding, and subsidies to foster innovation, scalability, and long-term sustainability. Incubation and Infrastructure support in the form of state-of-the-art incubation centres, Centre of Excellence and R&D hubs to provide startups with essential resources and support. The other pillars of the expected policy to be released soon include Mentoring and Skill Development for fostering innovation and entrepreneurship in Karnataka’s startup ecosystem. Funding for specialized training programme, subsidies for industry certification, grants for startup focused skilling initiatives, incubation-linked training grants and mentorship-driven financial support shall help nurture the next generation startup leaders. Market Access and Expansion for startups aiming to scale and enter new regions. The state shall facilitate global partnerships, government procurement incentives that support startups to reach wider audiences and strengthen their market presence. The last three pillars of the policy include International Collaboration and access to promote global engagement by facilitating international partnerships, cross-border innovation, and access to overseas markets. Through targeted strategic initiatives, startups gain exposure to global ecosystems, mentorship, and go-to-market support. Inclusion and Sustainability to encourage startups and young entrepreneurs to leverage disruptive technologies and innovative business models to address pressing social impact challenges. Regulatory Facilitation aimed to streamline regulatory processes for startups by promoting simplified compliance, single-window clearances, and proactive engagement with relevant authorities. Key enablers include a unified Startup Portal 2.0, legal and financial clinics, regulatory sandboxes, and simplified compliance. Currently undergoing stakeholder consultations and review, the policy aims to establish a future-ready framework to strengthen Karnataka’s startup ecosystem—especially Beyond Bengaluru—by fostering innovation, attracting investment, and creating high-value jobs. ]]> https://biospectrumindia.com/news/22/26489/cdsco-gives-positive-recommendation-to-servier-to-use-vorasidenib-for-brain-cancer-patients.html https://biospectrumindia.com/news/22/26489/cdsco-gives-positive-recommendation-to-servier-to-use-vorasidenib-for-brain-cancer-patients.html Wed, 06 Aug 2025 00:00:00 +0530 Servier India, a research-driven pharmaceutical organisation focused on oncology and specialty therapeutic areas, has received a positive recommendation from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) to import and market Vorasidenib Tablets 10 mg and 40 mg in India. The committee granted a waiver for local Phase-III clinical trials, acknowledging the drug’s orphan drug status in other countries and the unmet medical needs in India. The committee further recommended that Servier should conduct Phase IV clinical trial on Indian patients for which the protocol should be submitted to CDSCO within 3 months of approval of the drug for review by the committee. Vorasidenib is a therapy for treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma (brain tumours) with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection. Headquartered in France, Servier relies on a strong geographical footprint; its medicines are available in close to 140 countries. The group achieved a revenue of €5.9 billion in 2024. ]]> https://biospectrumindia.com/news/22/26475/government-of-punjab-launches-cancer-care-pathways.html https://biospectrumindia.com/news/22/26475/government-of-punjab-launches-cancer-care-pathways.html Mon, 04 Aug 2025 00:00:00 +0530 The Government of Punjab has launched the Punjab Cancer Care Pathways — a comprehensive initiative introducing Standard Treatment Guidelines (STGs) and streamlined care models for breast, cervical, oral, lung, and liver cancers.The pathways were developed and authored by the expert team from AIIMS Delhi, in collaboration with the Department of Health & Family Welfare, Punjab.The official launch was held in the presence of the Health Minister of Punjab, key contributors, and representatives from the World Health Organization (WHO), ICMR, PGIMER, and other national institutions. This is more than a document — it is a mission to ensure timely detection, evidence-based treatment, and survivor-focused care for the people of Punjab. ]]> https://biospectrumindia.com/news/22/26480/ministry-of-ayush-signs-two-strategic-mous-to-strengthen-conservation-and-public-awareness-of-medicinal-plants.html https://biospectrumindia.com/news/22/26480/ministry-of-ayush-signs-two-strategic-mous-to-strengthen-conservation-and-public-awareness-of-medicinal-plants.html Mon, 04 Aug 2025 00:00:00 +0530 Two significant Memoranda of Understanding (MoUs) have been signed by the National Medicinal Plants Board (NMPB), Ministry of Ayush, Government of India in the presence of Union Minister of State of Ayush (Independent Charge) and Minister of State for Ministry of Health and Family Welfare, Prataprao Jadhav, at Nirman Bhawan, New Delhi. The first MoU has been signed between the National Medicinal Plants Board (NMPB) and IshVed-Bioplants Venture, Pune, Maharashtra, and the second tripartite MoU was signed among National Medicinal Plants Board (NMPB), All India Institute of Ayurveda (AIIA) and All India Institute of Medical Sciences (AIIMS), New Delhi. The MoU between NMPB and IshVed-Bioplants Venture will bring better value to the stakeholders through development of tissue culture methods and their extensive cultivation and maintenance protocols to facilitate the supply of medicinal plants in the rare, endangered, and threatened (RET) category used in Ayush industry, in order to preserve and maintain the germplasm of these medicinal plants. On the other hand, the MoU among NMPB, AIIA, and AIIMS will develop public awareness about the medicinal plants among patients and students who come from distant areas and will also benefit the visitors in the hospital premises. ]]> https://biospectrumindia.com/news/22/26430/medtech-sector-hails-india-uks-comprehensive-economic-and-trade-agreement.html https://biospectrumindia.com/news/22/26430/medtech-sector-hails-india-uks-comprehensive-economic-and-trade-agreement.html Thu, 24 Jul 2025 00:00:00 +0530 India and the United Kingdom (UK) have taken a major step in building a stronger economic partnership with the signing of the Comprehensive Economic and Trade Agreement (CETA) under the visionary leadership of  Prime Minister Narendra Modi. The agreement was signed by Commerce and Industry Minister, Piyush Goyal and Secretary of State for Business and Trade, Jonathan Reynolds in the presence of the two Prime Ministers. CETA secures unprecedented duty-free access for 99% of India’s exports to the UK, covering nearly the entire trade basket. This is expected to open new opportunities for many industries including the medtech and healthcare sectors. Pavan Choudary, Chairman, Medical Technology Association of India, MTaI said, "The UK-India FTA is a landmark agreement that goes beyond tariff reductions, it signals India’s strategic ascent as a trusted partner in the global healthcare and technology value chain. As part of this agreement, import duties on MedTech products will be reduced from approximately 15% to around 3%, significantly lowering costs and improving access to advanced medical technologies. This partnership also opens doors for technology transfers, joint ventures, and skilling - which is a key ingredient for building a resilient healthcare ecosystem for both the countries." The agreement has been designed to make trade more inclusive. Women and youth entrepreneurs, farmers, fishermen, startups, and MSMEs will gain new access to global value chains, supported by provisions that encourage innovation, promote sustainable practices, and reduce non-tariff barriers. Dr Shravan Subramanyam, MD of BPL Medical Technologies said, "The signing of the India–UK Free Trade Agreement, eliminating tariffs for nearly 99% of Indian medical device exports, marks a transformative step for India’s medical technology sector. This policy will accelerate our growth in key markets like the UK by boosting competitiveness and reducing costs. At BPL Medical Technologies, our comprehensive product portfolio along with our ISO-certified factories in Bengaluru and Palakkad allow us to stay ahead and aligned with the Make in India vision to deliver advanced, affordable solutions for global healthcare needs. In FY24, India exported over Rs 1,015 crore worth of medical devices to the UK - a 13.11% annual increase. With this agreement, we are poised for even greater expansion, helping balance trade and integrating more deeply into global value chains." ]]> https://biospectrumindia.com/news/22/26367/niti-aayog-designs-roadmap-to-strengthen-state-science-technology-councils.html https://biospectrumindia.com/news/22/26367/niti-aayog-designs-roadmap-to-strengthen-state-science-technology-councils.html Thu, 10 Jul 2025 00:00:00 +0530 Union Minister of State (Independent Charge) for Science & Technology, Dr Jitendra Singh has unveiled the ‘NITI Aayog’s Roadmap for Strengthening State Science and Technology (S&T) Councils’. The roadmap is a major step toward building a robust and coordinated science and technology ecosystem across the States to fuel India’s transformation into a knowledge-driven economy. Delivering the keynote address, Dr Jitendra Singh identified Science and Technology as the key growth engine of India’s economic rise, stating that “if India is to move from the 4th to the 3rd largest economy and beyond, it is science and technology that will drive this growth.” The Minister described the recently established Anusandhan National Research Foundation (ANRF) as a game-changer that will bridge gaps between academia, industry and government, facilitating co-creation and co-investment in research. He also praised the emerging Bio-E3 cell ecosystem, backed by the Prime Minister, stating, “The next big revolution will be biotech-driven, and India is set to lead the world.” Vice Chairman of NITI Aayog, Suman Bery, emphasised the urgent need for such a roadmap to ensure that State S&T Councils align their efforts with national development goals and drive innovation that is both inclusive and sustainable. NITI Aayog Member Dr V.K. Saraswat observed that “sustainability must be embedded into the innovation process,” and highlighted the importance of capacity building at the state level to achieve long-term scientific excellence. ]]> https://biospectrumindia.com/news/22/26355/karnataka-govt-inks-mou-with-berlin-to-deepen-cooperation-in-innovation.html https://biospectrumindia.com/news/22/26355/karnataka-govt-inks-mou-with-berlin-to-deepen-cooperation-in-innovation.html Wed, 09 Jul 2025 00:00:00 +0530 The IT BT Department, Government of Karnataka has signed a landmark Memorandum of Understanding (MoU) with the State of Berlin, marking a significant advancement in its innovation partnership that began in 2022.This strategic alliance will create unprecedented opportunities for startups, researchers, and technology enterprises across both ecosystems. Berlin’s decision to establish its India headquarters in Bengaluru reinforces Karnataka’s position as a premier global innovation destination.Key collaboration areas include-* Startup soft-landing and market access facilitation* FinTech and digital innovation initiatives* AI research and development partnerships* Talent mobility and knowledge exchange programmes* Joint events and sectoral delegationsThis partnership exemplifies the government's commitment to fostering cross-border innovation networks. The government welcomes Berlin’s startup ecosystem to Karnataka while simultaneously creating pathways for innovators to access European markets.Together, both countries building bridges that will enable startups, talent, and industries to thrive in an interconnected global innovation ecosystem. ]]> https://biospectrumindia.com/news/22/26314/cabinet-approves-research-development-and-innovation-rdi-scheme-with-corpus-of-rs-1-lakh-crore.html https://biospectrumindia.com/news/22/26314/cabinet-approves-research-development-and-innovation-rdi-scheme-with-corpus-of-rs-1-lakh-crore.html Wed, 02 Jul 2025 00:00:00 +0530 In a transformative step to bolster India’s research and innovation ecosystem, the Union Cabinet, chaired by Prime Minister Narendra Modi, has approved the Research Development and Innovation (RDI) Scheme with a corpus of Rs one lakh crore. Recognising the critical role that the private sector plays in driving innovation and commercialising research the RDI Scheme aims to provide long-term financing or refinancing with long tenors at low or nil interest rates to spur private sector investment in RDI. The scheme has been designed to overcome the constraints and challenges in funding of private sector and seeks to provide growth & risk capital to sunrise and strategic sectors to facilitate innovation, promote adoption of technology and enhance competitiveness.  Key objectives of the Scheme are as follows: a)   Encourage the private sector to scale up research, development, and innovation (RDI) in sunrise domains and in other sectors relevant for economic security, strategic purpose, and self-reliance b)   Finance transformative projects at higher levels of Technology Readiness Levels (TRL) c)    Support acquisition of technologies which are critical or of high strategic importance d)   Facilitate setting up of a Deep-Tech Fund of Funds The Governing Board of Anusandhan National Research Foundation (ANRF), chaired by the Prime Minister, will provide overarching strategic direction to the RDI Scheme. The Executive Council (EC) of ANRF will approve the Scheme’s guidelines, and recommend 2nd level fund managers and scope and type of projects in sunrise sectors. An Empowered Group of Secretaries (EGoS) led by the Cabinet Secretary, will be responsible for approving scheme changes, sectors and types of projects as well as second-level fund managers besides reviewing the performance of the Scheme. The Department of Science and Technology (DST) will serve as the nodal department for implementation of RDI Scheme.  The RDI Scheme will have a two-tiered funding mechanism. At the first level, there will be a Special Purpose Fund (SPF) established within the ANRF, which will act as the custodian of funds. From the SPF funds shall be allocated to a variety of 2nd level fund managers. This will be mainly in the form of long-term concessional loans. The funding to R&D projects by the 2nd level fund managers would normally be in the form of long-term loan at low or nil interest rates. Financing in the form of equity may also be done, especially in case of startups. Contribution to Deep-Tech Fund of Funds (FoF) or any other FoF meant for RDI may also be considered. ]]> https://biospectrumindia.com/news/22/26323/republic-of-kazakhstan-and-government-of-telangana-explore-business-collaboration-in-healthcare.html https://biospectrumindia.com/news/22/26323/republic-of-kazakhstan-and-government-of-telangana-explore-business-collaboration-in-healthcare.html Wed, 02 Jul 2025 00:00:00 +0530 In a significant step towards deepening economic and cultural ties, the Deputy Chief Minister of Telangana, Batti Vikramarka Mallu, and Dr Nawab Mir Nasir Ali Khan, Honorary Consul of the Republic of Kazakhstan in Hyderabad for Telangana and Andhra Pradesh, met at the Deputy CM's official residence, to explore collaborative opportunities between the Republic of Kazakhstan and the Government of Telangana. The high-level meeting focused on expanding bilateral trade, healthcare, education, and connectivity. Dr Khan apprised the Deputy Chief Minister of the recent MoU between Hyderabad-based MSN Laboratories and Kazakh Invest for establishing a pharmaceutical manufacturing facility in Kazakhstan, a milestone in Indo-Kazakh cooperation. Another key highlight was the discussion on proposed direct flight services between Hyderabad and Almaty, Kazakhstan, which are currently under consideration.  In the healthcare and education sectors, Dr Khan mentioned ongoing discussions with Dr Srinivas Rao, CEO of Apollo Hospitals Group, to establish a medical education institution and a world-class hospital in Kazakhstan. Impressed by the growing ties and potential, the Hon’ble Deputy Chief Minister extended the Government of Telangana’s full support to all such initiatives. He also accepted Dr Khan’s formal invitation to visit Kazakhstan.   ]]> https://biospectrumindia.com/news/22/26297/punjab-government-launches-data-intelligence-technical-support-unit-to-strengthen-fight-against-drugs.html https://biospectrumindia.com/news/22/26297/punjab-government-launches-data-intelligence-technical-support-unit-to-strengthen-fight-against-drugs.html Sat, 28 Jun 2025 11:00:00 +0530 In a decisive step towards combating drug and substance abuse, the Government of Punjab has launched the Data Intelligence and Technical Support Unit (DITSU) - a pioneering initiative under its flagship campaign Yudh Nasheyan Virudh (War Against Drugs). This first-of-its-kind public-private collaboration is supported by the Ananya Birla Foundation (ABF) and is poised to drive systemic, data-driven reforms to create a drug-free Punjab. The launch was formalised through the signing of a Memorandum of Understanding between Bhagwant Mann, Chief Minister of Punjab and Ananya Birla, Founder of ABF.  DITSU will serve as the state's central technical and data insights hub, enabling the development of evidence-based policies, strategic interventions, and improved coordination across enforcement agencies, healthcare systems, and community-based organisations. The unit will be headquartered at the Dr. B.R. Ambedkar State Institute of Medical Sciences, Mohali. As part of the collaboration, the Ananya Birla Foundation will provide strategic support for hiring of key personnel, including the co-development of a digital platform for real-time tracking of Drugs of Concern (DoC). This will significantly strengthen monitoring and timely response capabilities across districts. The partnership is designed to drive impact across several key areas which include capacity building through training and up-skilling of psychologists, counsellors, peer educators, and frontline health workers; launching evidence-based prevention programmes and awareness campaigns in schools and colleges; and facilitating seamless collaboration between state departments, academic institutions, and law enforcement.   ]]> https://biospectrumindia.com/news/22/26250/govt-announces-policy-reforms-to-enhance-ease-of-innovation-research-and-science.html https://biospectrumindia.com/news/22/26250/govt-announces-policy-reforms-to-enhance-ease-of-innovation-research-and-science.html Mon, 16 Jun 2025 00:00:00 +0530 In a major policy shift aimed at streamlining the research environment in India, Union Minister of State (Independent Charge) for Science and Technology Dr Jitendra Singh has announced a set of policy reforms to enhance the Ease of Innovation and Ease of Doing Research, providing long-awaited relief to innovators, researchers scholars, scientists and institutions across the country. Addressing a press conference at The National Media Centre, Dr Jitendra Singh unveiled decisions that will enable academic and research institutions to bypass some of the most cited hurdles in their day-to-day functioning—particularly around procurement delays and financial ceilings. The announcement follows extensive consultations led by the Principal Scientific Adviser’s office, drawing insights from 13 IITs and multiple research bodies across India. One of the most consequential decisions announced is the delegation of procurement powers to institutional heads. Directors of scientific organisations and Vice Chancellors of universities will now be empowered to carry out non-GeM (Government e-Marketplace) purchases for specialised research equipment and materials—a departure from the existing rules which mandated GeM procurement even when suitable items were unavailable. The government has also revised key financial thresholds under the General Financial Rules (GFR). The ceiling for direct purchases has been doubled from Rs 1 lakh to Rs 2 lakh, while the range for purchases through departmental committees has been raised from Rs 1-10 lakh to Rs 2-25 lakh. Similarly, the limits for limited tender enquiries and advertised tenders have been increased from Rs 50 lakh to Rs1 crore. Additionally, heads of institutions can now approve Global Tender Enquiries (GTEs) up to Rs 200 crore—previously a power reserved for central authorities. ]]> https://biospectrumindia.com/news/22/26221/govt-announces-launch-of-youth-engagement-programme-and-dashboard-under-one-health-mission.html https://biospectrumindia.com/news/22/26221/govt-announces-launch-of-youth-engagement-programme-and-dashboard-under-one-health-mission.html Mon, 09 Jun 2025 22:00:00 +0530 The first State and Union Territory (UT) Engagement Workshop under National One Health Mission (NOHM) concluded on 9th June 2025, charting a collaborative path forward for strengthening India's integrated One Health approach. Chaired by Prof. Ajay Sood, Principal Scientific Adviser (PSA) to the Government of India, the workshop brought together a diverse array of stakeholders, including state government officials, representatives of all the stakeholder departments, and other agencies. During the inaugural session, PSA launched the Youth Engagement Programme for One Health mission. This programme is an initiative to actively engage with the youth of the nation through existing national platforms and state machinery to leverage their involvement in the mission. Additionally, a dashboard on One Health initiatives by states, central ministry/departments and multilaterals was launched and is accessible through the Office of PSA website (https://www.psa.gov.in/oneHealthDashboard). This dashboard is in development and currently hosts the various initiatives by the respective agencies. Prof. Sood as a way forward called on all the states/UT’s to consider creating their own One Health dashboards and websites and link it with the central dashboard/website. He further said that there should be focus on capacity building and courses/modules can be developed on platform like iGoT Karmyogi for One Health. He also empathised on the need of data standardisation, youth participation through One Health hackathons. ]]> https://biospectrumindia.com/news/22/26212/govt-opens-investor-facilitation-portal-for-traditional-medicine-sector.html https://biospectrumindia.com/news/22/26212/govt-opens-investor-facilitation-portal-for-traditional-medicine-sector.html Fri, 06 Jun 2025 00:00:00 +0530 The Government of India has launched the Ayush Nivesh Saarthi portal, a dedicated, investor-centric digital platform developed by the Ministry of Ayush in collaboration with Invest India. It brings together policy frameworks, incentive structures, investment-ready projects, and real-time facilitation under one unified interface. Designed to support both domestic and global investors, the platform is a strategic tool that strengthens India’s standing as a global investment destination for traditional systems of medicine. India’s Ayush industry has emerged as one of the fastest-growing sectors in the country, recording an annual growth of 17% between 2014 and 2020. With rising global consumer interest in natural, preventive, and wellness-based healthcare, Ayush is at the forefront of a new wave in global health and lifestyle transformation. The Ayush sector’s relevance is also strongly reflected in its contributions to medical value travel (MVT) and the global wellness economy. Ranked among the top five health services in India, Ayush is a key driver of the country’s $13 billion MVT sector Globally. With the launch of Ayush Nivesh Saarthi, the Government of India has reaffirmed its vision of making Ayush a pillar of both public health and economic growth. This portal is expected to serve as a vital catalyst in attracting foreign direct investment, empowering entrepreneurs, and showcasing India’s leadership in traditional medicine and wellness to the world. ]]> https://biospectrumindia.com/news/22/26188/ayush-ministry-launches-portal-to-address-issues-of-adverse-drug-reaction.html https://biospectrumindia.com/news/22/26188/ayush-ministry-launches-portal-to-address-issues-of-adverse-drug-reaction.html Fri, 30 May 2025 00:00:00 +0530 In a landmark step toward strengthening consumer protection and regulatory oversight in the field of traditional medicine, the Union Minister of State (Independent Charge), Ministry of Ayush; and Union Minister of State, Ministry of Health & Family Welfare, Government of India, Prataprao Jadhav, has launched the AyushSuraksha Portal. The portal was unveiled during a press briefing, marking a significant moment in the Ministry’s efforts to enhance accountability and transparency across the Ayush sector. “The AyushSuraksha Portal represents a significant advancement in pharmacovigilance and regulatory convergence within the Ayush ecosystem. By integrating data from State Licensing Authorities, national pharmacovigilance centres, and key regulatory stakeholders, the portal facilitates real-time monitoring, systematic analysis, and coordinated action on misleading advertisements and adverse drug reactions. We have made it accessible to the public so that any citizen can directly report misleading ads or adverse drug reactions (ADRs) via the portal,” said Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush. The Ayush Suraksha Portal has been developed in accordance with the Supreme Court’s order dated July 30, 2024, in Writ Petition (Civil) No. 645/2022, wherein the Court emphasised the need for a centralised dashboard for monitoring and publishing data related to misleading advertisements and adverse drug reactions. The Court directed the Union of India to ensure that such a system is established to allow State Licensing Authorities to report complaints, share inter-state referrals, and update the status of actions taken. The Ministry of Ayush has met the directive well before the Court’s deadline of June 2025. The portal, developed with the technical support of the Central Council for Research in Siddha (CCRS) and aligned with the National Pharmacovigilance Program, allows consumers, healthcare professionals, and regulatory authorities to report and monitor misleading advertisements and adverse drug reactions through a seamless digital process. The system integrates multiple authorities, including the Ayush vertical under CDSCO, MoI&B, CCPA, NCISM, NCH, PCI, FSSAI, and State Licensing Authorities, ensuring coordinated response and enforcement. A pre-launch training session for nodal officers from these organisations was successfully conducted on April 9, 2025, under the chairmanship of Dr. Kousthubha Upadhyaya, Adviser (Ayu.), Ministry of Ayush. With the launch of this portal, the Ministry of Ayush now has a centralised and accessible dashboard of reported cases, enabling real-time tracking, swift regulatory action, and detailed data analysis. The system also ensures that citizens have a direct channel to voice their concerns, with transparent visibility into the action taken on their reports. ]]> https://biospectrumindia.com/news/22/26185/astrazeneca-india-receives-cdsco-approval-for-additional-indication-for-osimertinib.html https://biospectrumindia.com/news/22/26185/astrazeneca-india-receives-cdsco-approval-for-additional-indication-for-osimertinib.html Thu, 29 May 2025 00:00:00 +0530 AstraZeneca India Pharma Ltd. (AZPIL), a global, science-led, patient focused pharmaceutical company, has received approval from the Central Drugs Standard Control Organisation (CDSCO), for the import, sale, and distribution of Osimertinib 40mg and 80mg tablets for an additional indication. The approval marks a critical step forward with Osimertinib as monotherapy in the treatment of patients with locally advanced, unresectable (Stage III) Non-Small Cell Lung Cancer (NSCLC) harbouring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy. This new indication represents a first-in-class treatment option in a setting for EGFR-mutated NSCLC post-chemoradiation. The approval follows compelling evidence from the Phase III LAURA trial, and demonstrated significant clinical benefits in delaying disease progression across different sub-groups, including CNS progression free survival with Osimertinib. Lung cancer continues to pose a major public health challenge in India, ranking as the fourth leading cause of cancer-related deaths, according to GLOBOCAN 2022. NSCLC accounts for approximately 85% of all lung cancers, with EGFR mutations seen in 33–37% of Indian patients with adenocarcinoma—a major subtype of NSCLC. The introduction of Osimertinib in EGFR+ locally advanced NSCLC offers renewed hope for a substantial patient population with limited options.   ]]> https://biospectrumindia.com/news/22/26166/india-partners-with-who-to-mainstream-ayush-globally.html https://biospectrumindia.com/news/22/26166/india-partners-with-who-to-mainstream-ayush-globally.html Mon, 26 May 2025 00:00:00 +0530 In a landmark development poised to transform the global standing of traditional medicine systems, an agreement has been signed between the Ministry of Ayush and the World Health Organization (WHO). The agreement marks the beginning of work on a dedicated Traditional Medicine module under the International Classification of Health Interventions (ICHI). The ICHI, complementing WHO’s International Classification of Diseases (ICD-11), documents what treatments and health interventions are administered. With the inclusion of a traditional medicine module, therapies from Ayurveda, Yoga, Siddha, and Unani systems—such as Panchakarma, Yoga therapy, Unani regimens, and Siddha procedures—will now be recognised in globally standardised terms. This will bring about multiple benefits: ● Transparent billing and fair pricing for Ayush services. ● Smoother integration of Ayush treatments in health insurance coverage. ● Enhanced hospital management, clinical documentation, and health research. ● Most importantly, greater global accessibility to Ayush interventions.   The combined impact of ICD-11 for diseases and the new ICHI module for interventions will ensure that Ayush becomes an integral, evidence-based, and policy-recognised part of global healthcare systems. ]]> https://biospectrumindia.com/news/22/26132/indian-glove-industry-awaits-implementation-of-quality-control-order.html https://biospectrumindia.com/news/22/26132/indian-glove-industry-awaits-implementation-of-quality-control-order.html Wed, 21 May 2025 00:00:00 +0530 Indian glove manufacturers are calling for the prompt implementation of the Medical and Surgical Gloves (Quality Control) Order (QCO), which has now been in the public domain for 60 days following its submission to the World Trade Organization (WTO) under the Technical Barriers to Trade (TBT) Agreement. The QCO, introduced by the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers, mandates Bureau of Indian Standards (BIS) certification for all medical and surgical gloves—both imported and domestically manufactured. While the industry welcomes and appreciates the government's decisive step toward protecting public health and supporting the domestic glove manufacturing sector, stakeholders are increasingly concerned over delays in enforcement. Manmohan Gulati, Secretary of the Indian Rubber Glove Manufacturers Association (IRGMA) said, “The 60-day WTO consultation period, which allows member countries and stakeholders to provide feedback, has now concluded. However, in the absence of formal notification, incidents of regulatory violations and illegal dumping of substandard gloves have continued to rise.” Anindith Reddy, Managing Director of Enliva – Wadi Surgicals, stated that,“The formal implementation of the QCO will be a breakthrough for domestic manufacturers which have been struggling to compete against the influx of low quality, non-compliant gloves. With the notification of QCO, manufacturing, storing and sale of non-BIS certified gloves will be prohibited. The timely implementation of the QCO is critical not only to curb the influx of low-quality imports but also to strengthen India's Make in India initiative by ensuring fair competition and promoting high-quality domestic production.” Industry estimates that the new QCO will directly impact the average annual import of Rs 450–500 crore worth of such illegal products, thereby ensuring only safe, certified gloves enter the Indian market. ]]> https://biospectrumindia.com/news/22/26109/govt-announces-first-of-its-kind-public-funded-bio-foundry-at-icgeb.html https://biospectrumindia.com/news/22/26109/govt-announces-first-of-its-kind-public-funded-bio-foundry-at-icgeb.html Wed, 14 May 2025 00:00:00 +0530 Addressing the "International Centre for Genetic Engineering and Biotechnology" (ICGEB) Board Meeting of Governors, Dr Jitendra Singh, Union Minister of State (Independent Charge) for Science & Technology, dedicated India’s first of its kind public funded DST-ICGEB ‘Bio-foundry’ in New Delhi. The facility will serve as a platform for scaling up bio-based innovations in collaboration with startups and researchers. ICGEB has 69 member countries and plays a key role in biotechnology-led sustainable global development through research, training, and technology transfer. The Minister described India as the emerging global biotech destination and said, this is the most appropriate venue for such deliberations at a time when India has much to contribute to the world community. Dr Jitendra Singh mentioned the development of India’s 1st of its kind Indigenous generation antibiotic for monotherapy in bacterial pneumonia Nafithromycin, backed in part by DBT-BIRAC. He also cited the creation of diagnostic kits for Dengue and HIV. Dr Rajesh Gokhale, Secretary of the Department of Biotechnology (DBT), highlighted India’s growing leadership in the biomedical and bio-industrial sectors, emphasising recent initiatives that are shaping the future of these domains.  ]]> https://biospectrumindia.com/news/22/26080/dbt-birac-announce-joint-call-for-proposals-on-bio-ai-hubs.html https://biospectrumindia.com/news/22/26080/dbt-birac-announce-joint-call-for-proposals-on-bio-ai-hubs.html Mon, 05 May 2025 00:00:00 +0530 The Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC) have issued a Joint Call for Proposals on Bio-AI for establishing मूलांकुर hubs under BioE3 Policy for Biomanufacturing. Bio-AI hubs are proposed to be established across academia and industry to provide critical and novel research leads impacting Health, Agriculture and Environment through conglomeration of AI and Biology. The Letter of Intent (LoI) for Bio-AI is uniquely designed to utilise AI in Biology for solving key biological challenges in Biomolecular Design, Sustainable Agriculture, Synthetic Biology, Ayurveda and Genome Diagnostics. Therefore, the problem statements in these domains as well as possible research solutions are invited from multi-disciplinary teams with research expertise across fields of synthetic biology, AI/ML and Computation to address complex biological research challenges. The problem statements are to be addressed by data-driven, cutting-edge, multi-disciplinary programmatic research initiatives for projected outcomes. The Union Cabinet approved the BioE3 (Biotechnology for Economy, Environment, & Employment) Policy, in August 2024, for ‘Fostering High-Performance Biomanufacturing’ across the country.  Subsequently, The Union Cabinet, chaired by the Prime Minister Narendra Modi, approved continuation of the two umbrella schemes of Department of Biotechnology (DBT), merged as one scheme-‘Biotechnology Research Innovation and Entrepreneurship Development (Bio- RIDE)’ with a new component namely Biomanufacturing and Biofoundry. With in the ambit of “High -Performance Biomanufacturing”, establishment of Bio-AI hubs for building of  data driven and cutting edge paradigms  in the areas of Health, Agriculture and Environment. ]]> https://biospectrumindia.com/news/22/26062/anusandhan-national-research-foundation-joins-hands-with-wadhwani-foundation.html https://biospectrumindia.com/news/22/26062/anusandhan-national-research-foundation-joins-hands-with-wadhwani-foundation.html Thu, 01 May 2025 00:00:00 +0530 In a significant move to accelerate the transformation of India’s research ecosystem, the Anusandhan National Research Foundation (ANRF) and the Wadhwani Foundation exchanged a landmark "Letter of Intent" in the presence of Prime Minister Narendra Modi, Union Science and Technology Minister, Dr Jitendra Singh and Union Education Minister, Dharmendra Pradhan. The partnership signals a first-of-its-kind collaboration between a government-backed apex research institution and a philanthropic private foundation, aimed at co-funding and scaling up research that can drive tangible societal impact. The agreement is also the inaugural step in ANRF’s strategy to foster expansive public-private partnerships across critical sectors of national relevance. The collaboration marks a turning point in how research will be funded and delivered in India in the times to come, emphasising inclusivity, interdisciplinary, and grassroots reach. In line with ANRF’s broader vision, this partnership aims to promote equitable access to resources and opportunities across the country, including tier-2 and tier-3 institutions, thereby fostering a more distributed and resilient research culture. With this new partnership, ANRF aims not only to fund cutting-edge science, but also to translate research into scalable, impactful solutions by aligning with national priorities and global challenges alike. Wadhwani Foundation’s involvement adds a crucial layer of experience in fostering entrepreneurship and innovation-driven development, especially among youth and startups. Together, the two entities will work to raise the scale and impact of late-stage translational research, projects that are often closest to delivering real-world outcomes but remain underfunded. ]]> https://biospectrumindia.com/news/22/26039/health-ministry-unveils-national-zero-measles-rubella-elimination-campaign.html https://biospectrumindia.com/news/22/26039/health-ministry-unveils-national-zero-measles-rubella-elimination-campaign.html Fri, 25 Apr 2025 00:00:00 +0530 Union Minister of Health and Family Welfare, Jagat Prakash Nadda virtually launched the National Zero Measles-Rubella Elimination campaign 2025-26 on the first day of the World Immunisation Week (24-30 April), marking a significant step towards India's goal of eliminating Measles and Rubella by 2026. On the occasion, Union Health Minister released multi-language M-R IEC materials (posters, radio jingles, MR elimination and official U-WIN launch film) for creating awareness in the communities. These IEC materials were also shared with all States/UTs for adaptation and rollout during the MR Elimination Campaign 2025-26.  Measles and Rubella are highly infectious viral diseases that can lead to serious illnesses, lifelong complications, and even death. Due to their high infection rate, India has set a goal to eliminate these diseases by 2026. In 2024, India has recorded a remarkable decline of 73% in Measles cases and a 17% reduction in Rubella cases in comparison with 2023. India's plan for eliminating measles and rubella includes a comprehensive framework: Immunisation: Achieve and maintain high population immunity with > 95% vaccination coverage with 2 doses of measles and rubella containing vaccines in each district of the country. Surveillance: Sustain a sensitive and timely case-based surveillance system for measles & rubella. Outbreaks: Ensure adequate preparedness and timely response to measles and rubella outbreaks. Linkages: Strengthen support and linkages to achieve the above strategic objectives. Demand Generation for Vaccination: Focused mass awareness campaigns to mitigate the risks of non-vaccination and dispel myths related to MR vaccine for addressing vaccine hesitancy and increasing coverage. ]]> https://biospectrumindia.com/news/22/25981/india-inks-mous-with-dubai-to-advance-academic-and-research-collaboration.html https://biospectrumindia.com/news/22/25981/india-inks-mous-with-dubai-to-advance-academic-and-research-collaboration.html Mon, 14 Apr 2025 00:00:00 +0530 Sheikh Hamdan bin Mohammed bin Rashid Al Maktoum, Crown Prince of Dubai, Deputy Prime Minister, and Minister of Defence of the UAE; and Piyush Goyal, India’s Minister of Commerce and Industry, witnessed the signing of eight Memorandums of Understanding (MoUs) aimed at deepening collaboration across key sectors including infrastructure, healthcare, higher education, maritime services, logistics, and private sector engagement. The MoUs were inked during a special event organised by Dubai Chambers in Mumbai. The signing ceremony formed part of Sheikh Hamdan bin Mohammed’s official visit to India. In a series of agreements that underscore the vital role of business communities in advancing collaboration and mutual growth, Dubai Chambers signed three Memorandums of Understanding (MoUs) with the Confederation of Indian Industry (CII), the Federation of Indian Chambers of Commerce and Industry (FICCI), and the IMC Chamber of Commerce and Industry. In another agreement that furthers a common commitment to delivering inclusive healthcare, Dubai Health signed an MoU to establish the UAE-India Friendship Hospital (UIFH), a new not-for-profit initiative aimed at providing inclusive and accessible healthcare, in Dubai.  Another agreement was formalised between the Dubai Medical University (DMU) and the All India Institute of Medical Sciences (AIIMS), the country’s top-ranked medical institute. The cooperation  agreement aims to strengthen academic and research collaboration by promoting direct cooperation between faculty, administrative staff, departments, and research centres of both institutions.Key areas of collaboration include student and staff exchange programmes, joint research in priority fields such as infectious diseases, metabolic disorders, and climate change, and the development of global health initiatives. The agreement also provides a framework for the exchange of academic materials and research publications. The agreement also covers cooperation with AIIMS in areas related to AI research, development, and digital transformation in medical education and healthcare. ]]> https://biospectrumindia.com/news/22/25977/india-and-italy-sign-mou-to-boost-cooperation-in-science-and-technology.html https://biospectrumindia.com/news/22/25977/india-and-italy-sign-mou-to-boost-cooperation-in-science-and-technology.html Fri, 11 Apr 2025 00:00:00 +0530 In a significant move to enhance bilateral scientific cooperation, Italy’s Minister of University and Research, Anna Maria Bernini, currently on India visit, called on Dr Jitendra Singh, Union Minister of State (Independent Charge) for Science and Technology. The hallmark of the meeting was the signing of a Memorandum of Understanding (MoU) of cooperation by the two Ministers. The discussions between the two dignitaries centered on advancing joint initiatives in quantum technologies, artificial intelligence, biotechnology, and other emerging sectors. Dr Jitendra Singh recalled the bilateral discussions between Prime Minister Narendra Modi and Italy's Prime Minister Giorgia Meloni held on the sidelines of the G20 Summit in Brazil, which culminated in the announcement of a Joint Strategic Action Plan 2025–2029. The plan outlines a shared vision for collaborative innovation in science and technology. As part of this vision, both nations signed a Memorandum of Understanding (MoU) for cooperation in the field of scientific research and agreed to implement the 2025–2027 Executive Programme for Scientific and Technological Cooperation, aimed at fostering collaboration in critical technologies like AI and digitalisation. Reaffirming India’s commitment to bilateral research, Dr Jitendra Singh announced the signing of the Indo-Italian Executive Programme of Cooperation (EPOC) for 2025–2027 on 10th April 2025 during the Joint Science & Technology Committee Meeting. Under the EPOC framework, both countries have successfully implemented over 150 joint research projects to date. The current programme includes joint funding for 10 research mobility proposals and 10 significant collaborative research initiatives across a wide range of scientific disciplines. ]]> https://biospectrumindia.com/news/22/25942/national-health-authority-mohfw-enters-into-mou-with-government-of-nct-delhi.html https://biospectrumindia.com/news/22/25942/national-health-authority-mohfw-enters-into-mou-with-government-of-nct-delhi.html Sat, 05 Apr 2025 00:00:00 +0530 In a historic event, Delhi became the 35th State/UT to implement the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) after the National Health Authority (NHA) of the Union Ministry of Health and Family Welfare (MoHFW) entered into a Memorandum of Understanding (MoU) with the Department of Health & Family Welfare, Government of NCT, Delhi.    The agreement was signed between L.S Changsan, Addl Secretary, MoHFW & Chief Executive Officer, National Health Authority (NHA), and Dr S.B. Deepak Kumar, Secretary (Health & Family Welfare), Department of Health & Family Welfare, Government of NCT Delhi.  Addressing the gathering, J P Nadda, Union Minister of Health and Family Welfare & Chemicals and Fertilizers stated, “It is a moment of pride that the world’s largest health coverage scheme which has been in place across 34 states and UTs in the country is finally getting implemented in the national capital as well.”  Citing a recent LANCET study, Nadda underlined that timely cancer treatment initiation has improved significantly because of the Ayushman Bharat Jan Aarogya Yojna. “Patients enrolled under AB-PMJAY saw 90% rise in access to cancer treatment within 30 days”, he stated. Rekha Gupta, Chief Minister, Government of NCT Delhi highlighted that beneficiaries will now gain access to 1,961 health benefit packages from 27 medical specialties, featuring updated procedures and better rates for hospitals. She also informed that card distribution for the scheme will be initiated from 10th April 2025 onwards. ]]> https://biospectrumindia.com/news/22/25911/andhra-pradesh-seeks-greater-collaboration-with-centre-to-boost-biotechnology.html https://biospectrumindia.com/news/22/25911/andhra-pradesh-seeks-greater-collaboration-with-centre-to-boost-biotechnology.html Tue, 01 Apr 2025 00:00:00 +0530 Andhra Pradesh’s Health Minister, Y. Satya Kumar, called on Union Minister of Science & Technology, Dr Jitendra Singh in the national capital, seeking greater collaboration in the field of biotechnology. During their discussion, the two leaders explored ways to upscale biotechnology-related projects in the state and enhance ongoing initiatives with central support. Satya Kumar highlighted Andhra Pradesh’s commitment to leveraging biotechnology for healthcare advancements and industrial applications. He stressed the need for increased cooperation to bring cutting-edge innovations to the state. Dr Jitendra Singh assured full support from the Centre, reaffirming that biotechnology remains a priority sector under the present government. He emphasised the transformative potential of biotechnology in sectors like healthcare, pharmaceuticals, and sustainable StartUps, noting that Andhra Pradesh could play a crucial role in driving such advancements. Dr Jitendra Singh noted that, over the years, Andhra Pradesh has emerged as a key player in India’s biotechnology sector, in areas such as biopharmaceutical research, marine biotechnology, and agricultural biotech solutions. The State hosts several biotech incubators and research institutions that have been instrumental in promoting innovation and entrepreneurship. With initiatives like the Biotechnology Industry Research Assistance Council (BIRAC) funding and national biotech missions, Andhra Pradesh has witnessed significant growth in biotech startups and industry partnerships, the Minister said. The renewed push for collaboration aims to further integrate the state into India’s broader biotechnology roadmap, he added. ]]> https://biospectrumindia.com/news/22/25886/health-ministry-releases-national-guidelines-on-medical-oxygen-management.html https://biospectrumindia.com/news/22/25886/health-ministry-releases-national-guidelines-on-medical-oxygen-management.html Thu, 27 Mar 2025 00:00:00 +0530 The Ministry of Health and Family Welfare has released the National Guidelines on Medical Oxygen Management at a workshop held at the All India Institute of Medical Sciences (AIIMS), Delhi. The workshop also marked the launch of the National Capacity Building Programme on Oxygen Management, which will be led by Department of Hospital Administration at AIIMS, Delhi. Punya Salila Srivastava, Union Health Secretary emphasised the critical role of properly maintaining and utilising medical oxygen infrastructure so that demands for any surge capacities may be met promptly at time of any exigencies. She also stressed on the need for inculcating learnings from India’s management of COVID-19 pandemic. Prof. M Srinivas, Director, AIIMS highlighted the institute’s role in spearheading the capacity-building programme and stressed the importance of training and awareness at all levels of healthcare. The release of National Guidelines on Medical Oxygen Management marks a significant step toward strengthening the country’s medical oxygen infrastructure and ensuring uniform best practices in oxygen management across healthcare facilities. The comprehensive guidelines provide a framework for the efficient procurement, storage, and administration of medical oxygen, with a focus on patient safety, capacity building, and emergency preparedness. The National Capacity Building Programme on Oxygen Management is an initiative led by the Disaster Management Cell of Ministry of Health and Family Welfare in collaboration with AIIMS, New Delhi. It aims to train around 200 master trainers across the country which in turn shall undertake capacity building of hospital administrators and medical officers across the country in proper handling and utilisation of medical oxygen, reducing wastage and improving clinical outcomes. ]]> https://biospectrumindia.com/news/22/25877/st-minister-announces-completion-of-10000-genome-sequences-of-mycobacterium-tuberculosis.html https://biospectrumindia.com/news/22/25877/st-minister-announces-completion-of-10000-genome-sequences-of-mycobacterium-tuberculosis.html Mon, 24 Mar 2025 00:00:00 +0530 In a significant breakthrough in the fight against tuberculosis (TB), Union Minister Dr Jitendra Singh announced the completion of genome sequencing of 10,000 isolates of “Mycobacterium tuberculosis” at a summit organised on the occasion of "World TB Day" at Vigyan Bhawan on March 24. The achievement marks a major stride in India's commitment to eradicating TB ahead of the World Health Organization’s (WHO) 2030 targets. The genome sequencing initiative is part of the Dare2eraD TB programme (Data Driven Research to Eradicate TB), launched on March 24, 2022, which focuses on data-driven research to eradicate TB. A key component of this initiative is the Indian Tuberculosis Genomic Surveillance (InTGS) Consortium, spearheaded by the Department of Biotechnology (DBT), the Council of Scientific and Industrial Research (CSIR), and the Indian Council of Medical Research (ICMR), in collaboration with major clinical institutions. The programme aims to sequence over 32,000 TB isolates to identify drug resistance mutations and improve treatment outcomes. Dr Rajesh Gokhale, Secretary DBT, hailed the completion of 10,000 genome sequences as a milestone achievement, adding that the data will be instrumental in strengthening India's TB surveillance and diagnostic capabilities. He stressed the importance of translating this research into practical applications that can be scaled up for real-world impact. With India accounting for a significant portion of the global TB burden, this breakthrough in genome sequencing is expected to bolster national and global efforts to combat the disease. The government’s continued investment in cutting-edge research, coupled with policy interventions and community participation, could pave the way for a TB-free India well ahead of its 2025 target. ]]> https://biospectrumindia.com/news/22/25848/icmr-strengthens-strategies-for-faster-and-more-accurate-diagnostics-of-tuberculosis.html https://biospectrumindia.com/news/22/25848/icmr-strengthens-strategies-for-faster-and-more-accurate-diagnostics-of-tuberculosis.html Tue, 18 Mar 2025 00:00:00 +0530 Union Minister of State for Health and Family Welfare, Anupriya Patel inaugurated the India Innovation Summit – Pioneering Solutions to End Tuberculosis (TB), at Bharat Mandapam Convention Centre, on 18th March in Delhi. The Summit is being organised jointly by the Department of Health Research-Indian Council of Medical Research (DHR-ICMR) and the Central TB Division (CTD), Ministry of Health & Family Welfare (MoHFW). The summit aims to accelerate India's progress towards TB elimination by 2025. Underlining the new innovations rolled out under the TB Mukt Bharat– 100 Days Intensified Campaign, the Minister stated that, “ICMR has validated three indigenous handheld X-ray devices, which makes it possible to reach vulnerable population groups for TB screening. Hand-held devices offer advantages of low weight, portability, and low radiation exposure and are being used in the 100-day accelerated programme.” She also added that “ICMR partnered with Institute of Plasma Research, Ahmedabad, to develop DeepCXR, a tool for artificial intelligence-based reporting chest X-ray films. ICMR has also validated CyTb skin test for detection of latent TB infection, developed by Serum Institute of India against Interferon gamma release assay (IGRA), which is the preferred test for latent TB detection. However, IGRA is expensive and it may not be feasible to be introduced in resource limited countries. Overall performance of CyTb was better than the currently used tuberculin skin test.” She further added that “ICMR conducted a multicentric validation of PathoDetect, an indigenous molecular diagnostic NAAT test which can perform 32 tests simultaneously, detects MTB complex and first line drug resistance to rifampicin (RIF) and Isoniazid (INH) simultaneously as a one step process. Overall, the performance of PathoDetect was comparable to other molecular assays. Deployment of this test in the 100-day programme, along with the already available TruNat test, has enhanced capacity of molecular diagnosis of TB and early detection of drug resistance. Moreover, the Quantiplus MTB FAST Detection Kit developed by Huwel Lifesciences is the first in world indigenous open system RTPCR kits developed in India and validated by ICMR. In comparison to the gold standard liquid culture, sensitivity of the kit is 86% and specificity is 96%. These kits are likely to be low-cost and have a potential to expand the outreach of TB molecular testing, including more than 3300 RTPCR machines used during the COVID-19 pandemic.” ]]> https://biospectrumindia.com/news/22/25843/cuba-explores-partnership-with-india-focusing-on-biomanufacturing-and-science.html https://biospectrumindia.com/news/22/25843/cuba-explores-partnership-with-india-focusing-on-biomanufacturing-and-science.html Mon, 17 Mar 2025 00:00:00 +0530 India and Cuba have reaffirmed their commitment to expanding bilateral cooperation in science and technology, particularly in biotechnology and biomanufacturing, as Cuba Deputy Prime Minister Dr Eduardo Martínez Díaz called on the Union Minister of State (Independent Charge) for Science and Technology; Earth Sciences and Minister of State for PMO, Department of Atomic Energy, Department of Space, Personnel, Public Grievances and Pensions Dr Jitendra Singh. The meeting, held on the occasion of the 65th anniversary of diplomatic relations between the two nations, explored avenues to deepen collaboration in medical research, vaccine development, and sustainable biomanufacturing. During the discussions, Dr Jitendra Singh emphasised that collaborative research is indispensable for a science-driven society to have a global influence at scale. He noted that joining hands with the best in the world and pursuing complementary, targeted research will propel India’s scientific community to the next level of innovation, transformation, and skill development. The Minister also stressed that the Department of Biotechnology (DBT) is increasingly focusing on collaborative research to tackle socio-economic and environmental challenges with long-term benefits. Both sides discussed strengthening existing agreements in health, medicine, and biotechnology, building upon previous MoUs on traditional medicine, homeopathy, and scientific collaboration. Given Cuba’s growing interest in Ayurveda and Indian naturopathy, both nations expressed optimism about expanding engagement in this sector. Cuba extended an invitation to Dr Jitendra Singh to visit Havana and lead an Indian delegation to Bio-Habana 2026, a global biotechnology conference. ]]> https://biospectrumindia.com/news/22/25827/department-of-biotechnology-and-assam-govt-sign-historic-mou-for-centre-state-partnership-under-bioe3-policy.html https://biospectrumindia.com/news/22/25827/department-of-biotechnology-and-assam-govt-sign-historic-mou-for-centre-state-partnership-under-bioe3-policy.html Fri, 14 Mar 2025 00:00:00 +0530 The Department of Biotechnology (DBT) and the Government of Assam have signed a landmark Memorandum of Understanding (MoU) under the BioE3 (Biotechnology for Economy, Environment, and Employment) Policy. This Centre-State partnership is the first of its kind under the BioE3 framework and aims to accelerate high-performance biomanufacturing while fostering a sustainable biotechnology ecosystem in Assam. The MoU signing is a culmination of extensive consultations, high-level meetings, and collaborative efforts made by the DBT and the Government of Assam. A landmark step in this journey was the Centre-State Partnership Conclave held last month under the chairpersonship of Union Minister of Science & Technology, Dr Jitendra Singh where the State Governments were encouraged to foster collaborations with the DBT and establish State BioE3 Cells. The MoU signed between DBT, and the Government of Assam formalises a strategic collaboration in which DBT will extend its guidance and facilitate partnerships, while the Government of Assam will spearhead initiatives by establishing a State BioE3 Cell and developing an Assam BioE3 Action Plan. This collaboration underscores Assam’s proactive approach to harnessing its rich biodiversity and agricultural strength to build a robust biomanufacturing ecosystem in the State. The MoU signing took place at DBT headquarters in New Delhi, in the presence of key dignitaries- Dr Rajesh S. Gokhale, Secretary, DBT, DG BRIC and Chairman BIRAC; Dr Ravi Kota, Chief Secretary, Government of Assam; Dr Alka Sharma, Senior Adviser/Sc‘H’, DBT; Pallav Gopal Jha, Secretary, Department of Science, Technology & Climate Change, Government of Assam; and Dr Jitendra Kumar, MD, BIRAC.   ]]> https://biospectrumindia.com/news/22/25826/shilpa-medicare-secures-regulatory-nod-for-nor-ursodeoxycholic-acid-tablets-targets-market-launch-for-nash-treatment.html https://biospectrumindia.com/news/22/25826/shilpa-medicare-secures-regulatory-nod-for-nor-ursodeoxycholic-acid-tablets-targets-market-launch-for-nash-treatment.html Thu, 13 Mar 2025 00:00:00 +0530 Raichur-based Shilpa Medicare Limited, a leading API and formulation manufacturer, has announced that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has approved its Investigational New Drug (IND) – Nor Ursodeoxycholic Acid (Nor UDCA) Tablets 500 mg – and recommended marketing authorisation for treating non-alcoholic fatty liver disease (NAFLD). NAFLD, the most prevalent liver disease, affects approximately 25% of the global population (1.2 billion people), including 188 million in India. Left untreated, NAFLD can progress to non-alcoholic steatohepatitis (NASH), a severe and potentially fatal condition. Shilpa Medicare had earlier completed phase-3 clinical studies of this novel product SMLNUD07 – Nor Ursodeoxycholic Acid (Nor UDCA) tablets - and presented the results of the trial titled, "A phase - III, Randomised, Double- Blind, placebo controlled, multicenter, Parallel group study", to evaluate the safety and efficacy of Nor-Ursodeoxycholic Acid 500 mg in patients suffering from Non-alcoholic Fatty Liver Disease to the SEC. The trial met all primary efficacy endpoints, demonstrating a significant improvement in fatty liver stage. 83.3% of participants showed fibrosis reversal, with stabilization in the rest. Elevated alanine transaminase (ALT) levels, a key NAFLD marker, normalized in ~90% of participants within 12 weeks. These results position Nor UDCA as a breakthrough therapy for NAFLD, offering advantages over conventional UDCA, including enhanced choleretic effect, resistance to amidation, anti-inflammatory properties, and fibrosis reduction.   ]]> https://biospectrumindia.com/news/22/25828/telangana-government-to-unveil-new-life-sciences-policy.html https://biospectrumindia.com/news/22/25828/telangana-government-to-unveil-new-life-sciences-policy.html Thu, 13 Mar 2025 00:00:00 +0530 Telangana is set to launch a dedicated Life Sciences policy in the coming weeks, marking a significant step towards strengthening the state’s leadership in the sector. The announcement was made by Jayesh Ranjan, Special Chief Secretary, Department of Industries, IT, Electronics, and Communications, during the launch of Tenthpin’s new Life Sciences facility in Hyderabad. Speaking at the event, Jayesh Ranjan stated that the upcoming policy will chart a bold new growth path for Telangana's Life Sciences industry. It will drive advancements in emerging domains such as cell and gene therapy, genomics, biologics, precision medicine, peptides, digital innovation, and advanced R&D. “Hyderabad has emerged as a global leader in Life Sciences and Pharmaceuticals, with over 1,800 pharma manufacturing units and the world’s largest vaccine manufacturing hub. The city is home to seven out of the top 10 global life sciences companies. The new policy will further position Telangana at the forefront of cutting-edge innovation,” he said. Highlighting the growing importance of Cell and Gene Therapy (CGT), Ranjan noted that this next-generation treatment has the potential to cure rare and severe diseases like cancer. Telangana's new Life Sciences Policy will offer strong support for this sector, encouraging research and investment. The government is also leveraging Hyderabad’s thriving innovation ecosystem, which includes 24 innovation spaces like T-Hub, to foster AI-driven advancements in Life Sciences.   Overall, with the upcoming Life Sciences policy, Telangana aims to further solidify its position as a global leader in biotechnology, pharmaceuticals, and AI-driven healthcare innovations. ]]> https://biospectrumindia.com/news/22/25803/health-minister-announces-launch-of-patent-mitra-to-support-medical-innovations.html https://biospectrumindia.com/news/22/25803/health-minister-announces-launch-of-patent-mitra-to-support-medical-innovations.html Mon, 10 Mar 2025 00:00:00 +0530 At the third “International Symposium on Health Technology Assessment (ISHTA 2025)” at Bharat Mandapam, New Delh, organised by the Department of Health Research (DHR), Ministry of Health and Family Welfare, Government of India, in collaboration with the World Health Organization (WHO) India Country Office and the Centre for Global Development (CGD), Union Minister of Health and Family Welfare, Jagat Prakash Nadda announced the launch of Patent Mitra initiative. Under the Guidance of NITI AAYOG, Indian Council of Medical Research (ICMR) in partnership with Department of Pharmaceuticals (DoP) and supported by Department for Promotion of Industry and Internal Trade (DPIIT), aims to build a robust and dynamic ecosystem that promotes innovation within biomedical research by providing comprehensive Patent and Technology Transfer (TT) support to innovators at every stage of the patent lifecycle, with a vision to translate innovative research in the biomedical domain to practical solutions driving meaningful advancements in public health across India. Medical Innovations Patent Mitra Initiative aims to support strategic and quality patent filings for innovative biomedical research with a vision to advance patent protection and facilitate seamless technology transfer for societal impact. "This platform is designed to provide crucial support to the scientists, researchers and institutions ensuring that their ground-breaking works are protected through patents and made available to public through seamless technology transfer”, the Minister stated. Nadda also highlighted that the "Medical Education Patent Mitra" initiative of ICMR aligns with the Med Tech Mitra initiative, a testament of ICMR’s commitment to advancing medical innovation. On the occasion, the Union Health Minister also released several key resources, including the Open Real-Time PCR Kit for Diagnosis of Pulmonary Tuberculosis (Quantiplus MTB FAST Detection Kit developed by Huwel Lifesciences), the HTA Technologies Compendium, and the HTA Costing Database. ]]> https://biospectrumindia.com/news/22/25805/auriga-research-signs-mou-with-assam-government-to-establish-pharma-testing-lab.html https://biospectrumindia.com/news/22/25805/auriga-research-signs-mou-with-assam-government-to-establish-pharma-testing-lab.html Mon, 10 Mar 2025 00:00:00 +0530 Auriga Research Private Limited, a trusted Indian leader in Testing, Inspection, and Certification (TIC) services, has signed two significant Memoranda of Understanding (MoUs) aimed at strengthening Assam’s food, pharmaceutical, and tea industries. The two agreements, signed with the Government of Assam and the Tea Research Association (TRA) during the Advantage Assam 2.0 Investment and Infrastructure Summit 2025, mark a transformative step toward enhancing quality assurance, regulatory compliance, and global competitiveness for Assam’s industries.  Auriga Research has partnered with the Government of Assam to establish an advanced testing laboratory for food, beverages, pharmaceuticals, Ayurveda, and medical devices. This state-of-the-art facility will be set up in Guwahati or Dibrugarh, with operations expected to commence within nine months. It will cater to both domestic businesses and export-driven industries, ensuring compliance with national and international quality standards. The Government of Assam will provide policy support, fast-track clearances, and facilitation services to ensure smooth implementation. This initiative aligns with Assam’s Ease of Doing Business (EoDB) policies and will further integrate the state into global supply chains, supporting India’s Make in India and Make for the World initiatives. Auriga Research will provide cost-effective, world-class testing solutions to producers, even small and mid-sized players to ensure compliance with stringent international regulations. ]]> https://biospectrumindia.com/news/22/25800/astrazeneca-receives-cdsco-nod-for-new-indication-for-treatment-of-limited-stage-small-cell-lung-cancer.html https://biospectrumindia.com/news/22/25800/astrazeneca-receives-cdsco-nod-for-new-indication-for-treatment-of-limited-stage-small-cell-lung-cancer.html Fri, 07 Mar 2025 00:00:00 +0530 AstraZeneca Pharma India, a science-led biopharmaceutical company, has received a Central Drugs Standard Control Organisation (CDSCO) approval to import for sale and distribution of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution for infusion. This approval pertains to a new indication - the treatment of patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT). Durvalumab is now the only approved consolidation therapy for LS-SCLC patients post-CRT, marking a pivotal shift in treatment strategy for this aggressive lung cancer subtype, which constitutes approximately 15% of all lung cancer cases. While most SCLC cases are diagnosed at advanced stages, nearly 25% of Indian patients present with LS-SCLC, highlighting an urgent need for enhanced early-stage interventions.  GLOBOCAN 2022 data identifies lung cancer as the fourth leading cause of cancer-related mortality in India. Historically, treatment for LS-SCLC was confined to platinum-based CRT. The ADRIATIC clinical trial, which included Indian participants, demonstrated that Durvalumab post-CRT significantly improves progression-free and overall survival compared to a placebo, reinforcing its role in optimising early-stage treatment outcomes.  Dr Hardik Vasnawala, Director Medical Affairs, AstraZeneca Pharma India Limited said, "This new Durvalumab indication approval is a pivotal step forward in improving outcomes for patients with LS-SCLC in the country and helps address the unmet patient needs”. ]]> https://biospectrumindia.com/news/22/25784/icmr-publishes-addendum-to-ethical-requirements-for-research-in-integrative-medicine.html https://biospectrumindia.com/news/22/25784/icmr-publishes-addendum-to-ethical-requirements-for-research-in-integrative-medicine.html Wed, 05 Mar 2025 00:00:00 +0530 The Indian Council of Medical Research (ICMR) has published an addendum to the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) to provide a structured ethical framework for Research in Integrative Medicine (RIM). Secretary, Ministry of Ayush, Vaidya Rajesh Kotecha highlighted the significance of the development and said, “The addition of these ethical guidelines marks a significant step in encouraging the scientific community to explore Integrative Medicine with greater credibility and confidence. By providing a structured ethical framework, we aim to inspire researchers to advance evidence-based integration of traditional and modern medicine, ensuring safe, effective, and scientifically validated healthcare solutions for all". Integrative Medicine (IM) involves a multimodal approach where Ayush systems are integrated alongside modern/conventional medicine to enhance patient care and improve health outcomes.  This addendum aims to guide researchers, institutions, Ethics Committees (ECs), and regulatory bodies involved in Integrative Medicine research, ensuring that scientific integrity and patient safety remain paramount. The addendum introduces key measures to enhance the ethical and regulatory framework for Integrative Medicine research. Ethics Committees overseeing such research must now include two Ayush subject-matter experts, with at least one being external to the institution, ensuring well-rounded and informed deliberations. Informed consent standards have been strengthened, requiring that research participants receive clear, tailored information about Integrative Medicine interventions while adhering to India's standard ethical guidelines for biomedical and clinical research. Additionally, Ayush-approved medicines used in integrative research will not require extra safety trials or preclinical studies. However, non-codified traditional medicines must undergo the entire regulatory approval process. To ensure compliance, all research must align with the Drugs & Cosmetics Act (1940), New Drugs & Clinical Trial Rules (2019), and Good Clinical Practice (GCP) guidelines specific to Ayush systems. ]]> https://biospectrumindia.com/news/22/25743/telangana-government-signs-mous-with-11-companies-for-green-pharma-city-project.html https://biospectrumindia.com/news/22/25743/telangana-government-signs-mous-with-11-companies-for-green-pharma-city-project.html Wed, 26 Feb 2025 00:00:00 +0530 The 22nd edition of BioAsia 2025, Asia’s largest life sciences and healthcare conference, themed ‘Catalysts of Change – Expanding Global Healthcare Frontiers, Transforming Healthcare with Innovation, Collaboration and Progress’ was inaugurated by A Revanth Reddy, Chief Minister of Telangana; Dr Jeannette Young, Governor of Queensland, and D Sridhar Babu, Minister for Industries and Commerce, Government of Telangana along with other dignitaries, on 25th February. Pharma MoUs were signed for the Green Pharma City, a flagship initiative of the Government of Telangana during the event. Already 6 pharma companies have signed MoUs with the government of Telangana with 11 more companies joining the initiative, as MoUs were signed with Granules, Orbicular, Aizant, Biological E, Virchow, Virupaksha, Jubilant, Vimta, Aragen, Bharat Biotech and Sai Life Sciences, bringing an investment of Rs 5445 crore, and creating 9800 new jobs. With these commitments, the total investment in Green Pharma City now stands at Rs 11,100 crore, with employment opportunities exceeding 22,300. A Revanth Reddy, Chief Minister of Telangana said, “We will develop Hyderabad and Telangana into one of the largest ecosystems for biosciences, biotech and life sciences innovation, R&D, manufacturing, skill development, and investment. We already have 160 Km outer ring road (ORR) and we are building a Regional Ring Road (RRR) of 360 Km outside the core urban area along with a network of radial roads connecting the two ring roads with radial roads and creating manufacturing hubs for pharma, EV’s data centres, green energy, seed manufacturing, agri-processing and other sectors. We are developing 10 pharma Villages between ORR and RRR which will generate over 5 lakh jobs. The Green Pharma city is also a key initiative under the Future City Project and is progressing rapidly. We have already signed 6 MoUs and signing another 11 MoUs today creating more jobs for the youth. We are all set to launch a new Life Sciences Policy which will chart a bold new growth trajectory for the sector. With this we will enter new domains such as cell and gene therapy, genomics, biologics, precision medicine, peptides, digital innovation, advanced R&D and complex manufacturing.” Sridhar Babu, Minister for Industries and Commerce, Government of Telangana, said, “We have witnessed several global life sciences companies open operations in the city  and have created more than 51,000 direct jobs and 1,50,000 indirect jobs over here.  We have inaugurated the Amgen’s largest innovation centre yesterday along with Miltenyi, cutting edge cell and gene therapy centre yesterday.    As we look to the future, our focus remains steadfast on skilling and workforce development.  We have established a skills university Young India Skills University  which will focus covering this gap. A key pillar in this mission is to establish a life sciences university which is progressing rapidly to equip Hyderabad workforce with industry relevant expertise. By collaborating closely with GCC Hyderabad we are designing a specialised curriculum in science and technology ensuring our talent remains globally competitive and Future ready. I am delighted to share the first batch of the chemistry skill programme successfully concluded this month. We are determined to insert Telangana into the global Pharma supply chain as a key player in terms of Bulk drug and also in generic pharma and be a world leader in the life sciences space.” ]]> https://biospectrumindia.com/news/22/25706/union-health-ministry-launches-intensified-special-ncd-screening-drive.html https://biospectrumindia.com/news/22/25706/union-health-ministry-launches-intensified-special-ncd-screening-drive.html Thu, 20 Feb 2025 00:00:00 +0530 In view of the escalating burden of Non-Communicable Diseases (NCDs) in the country, the Ministry of Health & Family Welfare has launched an Intensified Special NCD Screening Campaign. Running from 20th February to 31st March 2025, this ambitious initiative aims to achieve 100% screening of all individuals aged 30 years and above for prevalent NCDs, including Diabetes, Hypertension, and three common cancers—Oral, Breast, and Cervical. The campaign will be executed across Ayushman Arogya Mandirs (AAMs) and various healthcare facilities nationwide, under the National Programme for Prevention and Control of Non-Communicable Diseases (NP-NCD). Trained ASHAs, ANMs, and frontline workers will conduct community visits to ensure maximum screening coverage, reaching individuals in their homes. States and Union Territories (UTs) will guarantee the availability of essential medical supplies, including BP monitors, glucometers, and necessary medications at all healthcare centres. Data on screening, treatment, and follow-ups will be uploaded daily on the NP-NCD Portal, ensuring transparency and accountability. Nodal officers will be appointed at facility, block, district, and state levels to facilitate seamless execution of the campaign. States and UTs will provide updates to the Ministry by 6 PM daily, allowing for continuous monitoring and technical support. ]]> https://biospectrumindia.com/news/22/25689/ministry-of-ayush-and-department-of-social-justice-ink-mou-to-enhance-geriatric-healthcare.html https://biospectrumindia.com/news/22/25689/ministry-of-ayush-and-department-of-social-justice-ink-mou-to-enhance-geriatric-healthcare.html Tue, 18 Feb 2025 00:00:00 +0530 In a landmark move aimed at improving the well-being of senior citizens and addressing the growing concern of substance abuse, the Ministry of Ayush and the Department of Social Justice and Empowerment (DoSJE) have signed a Memorandum of Understanding (MoU) in New Delhi. This strategic partnership seeks to implement Ayush-based interventions to promote geriatric healthcare and combat substance abuse. The MoU is a pioneering step to develop cooperative initiatives for health promotion among senior citizens and those affected by substance abuse. By leveraging the strengths of Ayush systems, both Ministries committed to working together on various initiatives, including awareness programmes, capacity-building for service providers and the establishment of geriatric health and de-addiction units under Ayush autonomous bodies. The focus will be towards developing cooperation, convergence, and synergy between the Ministry of Ayush and DoSJE to foster innovative initiatives for promoting the health of senior citizens, reducing the demand for drugs, addressing substance abuse, and aiding mental rehabilitation. This will be achieved through awareness generation and capacity building of service providers using Ayush systems. Research will be encouraged in the areas of geriatric health, substance abuse, and mental health, with a focus on exploring the therapeutic benefits of traditional healthcare practices. Additional activities will be supported for health promotion tailored to both the geriatric population and individuals affected by substance abuse. ]]> https://biospectrumindia.com/news/22/25681/us-and-india-announce-partnership-to-strengthen-emerging-technologies.html https://biospectrumindia.com/news/22/25681/us-and-india-announce-partnership-to-strengthen-emerging-technologies.html Sun, 16 Feb 2025 00:00:00 +0530 The President of the United States of America, Donald J. Trump recently hosted the Prime Minister of India, Narendra Modi for an Official Working Visit in Washington, DC. The leaders announced the launch of the US-India TRUST ("Transforming the Relationship Utilising Strategic Technology”) initiative, which will catalyse government-to-government, academia and private sector collaboration to promote application of critical and emerging technologies in areas like defense, artificial intelligence (AI), semiconductors, quantum, biotechnology, energy and space, while encouraging the use of verified technology vendors and ensuring sensitive technologies are protected. As a central pillar of the 'TRUST' initiative, the leaders committed to work with US and Indian private industry to put forward a US-India Roadmap on Accelerating AI Infrastructure by the end of the year, identifying constraints to financing, building, powering, and connecting large-scale U.S.-origin AI infrastructure in India with milestones and future actions. The US and India will work together to enable industry partnerships and investments in next generation data centers, cooperation on development and access to compute and processors for AI, for innovations in AI models and building AI applications for solving societal challenges while addressing the protections and controls necessary to protect these technologies and reduce regulatory barriers. The leaders underscored the value of deepening ties between the U.S. and Indian scientific research communities, announcing a new partnership between the US National Science Foundation and the Indian Anusandhan National Research Foundation in researching critical and emerging technologies. This partnership builds on ongoing collaboration between the U.S. National Science Foundation and several Indian science agencies to enable joint research in the areas of semiconductors, connected vehicles, machine learning, next-generation telecommunications, intelligent transportation systems, and future biomanufacturing. ]]> https://biospectrumindia.com/news/22/25670/ministry-of-ayush-inks-mou-to-enhance-geriatric-healthcare-and-combat-substance-abuse.html https://biospectrumindia.com/news/22/25670/ministry-of-ayush-inks-mou-to-enhance-geriatric-healthcare-and-combat-substance-abuse.html Wed, 12 Feb 2025 00:00:00 +0530 In a landmark move aimed at improving the well-being of senior citizens and addressing the growing concern of substance abuse, the Ministry of Ayush and the Department of Social Justice and Empowerment (DoSJE) have signed a Memorandum of Understanding (MoU). This strategic partnership seeks to implement Ayush-based interventions to promote geriatric healthcare and combat substance abuse. The MoU is a pioneering step to develop cooperative initiatives for health promotion among senior citizens and those affected by substance abuse. By leveraging the strengths of Ayush systems, both Ministries committed to working together on various initiatives, including awareness programs, capacity-building for service providers and the establishment of geriatric health and de-addiction units under Ayush autonomous bodies. Key objectives of the MoU include: Cooperative Efforts: Developing cooperation, convergence, and synergy between the Ministry of Ayush and DoSJE to foster innovative initiatives for promoting the health of senior citizens, reducing the demand for drugs, addressing substance abuse, and aiding mental rehabilitation. This will be achieved through awareness generation and capacity building of service providers using Ayush systems. Research Promotion: Encouraging research in the areas of geriatric health, substance abuse, and mental health, with a focus on exploring the therapeutic benefits of traditional healthcare practices. Health Promotion Activities: Supporting additional activities for health promotion tailored to both the geriatric population and individuals affected by substance abuse. ]]> https://biospectrumindia.com/news/22/25654/biovet-gets-cdsco-license-for-worlds-first-ever-diva-marker-vaccine-for-lumpy-skin-disease-.html https://biospectrumindia.com/news/22/25654/biovet-gets-cdsco-license-for-worlds-first-ever-diva-marker-vaccine-for-lumpy-skin-disease-.html Mon, 10 Feb 2025 00:00:00 +0530 Bharat Biotech group company Biovet, an innovative animal health vaccine producer based in Mallur, Karnataka, has announced that its Lumpy Skin Disease (LSD) vaccine for dairy cattle and buffaloes, BIOLUMPIVAXIN, the world's safest and first-ever Differentiating Infected from Vaccinated Animals (DIVA) marker vaccine, has received a license from the Central Drug Standards Control Organisation (CDSCO). The soon-to-be-launched BIOLUMPIVAXIN is the world's only marker vaccine for LSD. It offers a high safety and efficacy profile while enabling serological differentiation between naturally infected and vaccinated animals with the DIVA concept in it. The quality, safety, and efficacy of the vaccine have been extensively tested at ICAR-NRCE and at the Indian Veterinary Research Institute (IVRI), ensuring it meets the highest global standards. This novel Indigenous live-attenuated marker vaccine was developed using the LSD virus/Ranchi/2019 vaccine strain from Indian Council of Agriculture Research-National Research Centre on Equines (ICAR-NRCE), Hisar, in collaboration with Bharat Biotech’s Biovet. Over the past two years, approximately 200,000 cattle have died, and millions more have lost their milk production capabilities due to Lumpy Skin Disease (LSD) nationwide. The LSD vaccine BIOLUMPIVAXIN will very soon be commercially available. The Biovet Mallur facility can produce 500 million doses of BIOLUMPIVAXIN® annually. ]]> https://biospectrumindia.com/news/22/25655/uk-gives-nod-to-glenmark-pharmas-winlevi-for-treatment-of-acne.html https://biospectrumindia.com/news/22/25655/uk-gives-nod-to-glenmark-pharmas-winlevi-for-treatment-of-acne.html Mon, 10 Feb 2025 00:00:00 +0530 Mumbai-based Glenmark Pharmaceuticals has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to market Winlevi in the United Kingdom. Winlevi is a topical treatment for acne vulgaris in patients aged 12 years and older, marking a significant milestone in the commitment of both companies to providing innovative, patient-focused dermatology solutions. Winlevi is the first topical acne treatment in nearly 40 years with a first-in-class mechanism of action. Its active ingredient, clascoterone, is the first commercially available topical androgen receptor inhibitor, targeting androgen receptors in sebaceous glands with no systemic anti-androgen effects, and as such it can be used safely in both males and females. This approach is believed to help reduce sebum production and intervene early in acne pathogenesis. Two identical phase 3 studies demonstrated that clascoterone cream,1%, applied topically twice daily for 12 weeks, was more effective than the application of vehicle cream in achieving the Investigator’s Global Assessment (IGA) of success, reducing non-inflammatory lesion count (NILC) and inflammatory lesion count (ILC) in patients with facial acne vulgaris. clascoterone cream, 1%, was generally well tolerated. As part of the agreement signed in September 2023, Glenmark has in-licensed the product from Ireland-based Cosmo Pharmaceuticals for distribution in Europe and South Africa.  According to Christoph Stoller, President & Business Head - Europe and Emerging Markets, Glenmark Pharmaceuticals, "This approval by the MHRA represents a significant step forward in our mission to enhance dermatology care. Our partnership with Cosmo Pharmaceuticals plays an important role in enabling us to expand our dermatology portfolio."     ]]> https://biospectrumindia.com/news/22/25649/st-minister-calls-on-states-to-establish-bioe3-cells-as-part-of-indias-biotechnology-revolution-.html https://biospectrumindia.com/news/22/25649/st-minister-calls-on-states-to-establish-bioe3-cells-as-part-of-indias-biotechnology-revolution-.html Sat, 08 Feb 2025 00:00:00 +0530 Union Minister Dr Jitendra Singh called on states to establish BioE3 Cells as part of India’s biotechnology revolution, with the aim of realising Bio-Vision for Viksit Bharat by 2047. During the Centre-State Partnership Conclave on the BioE3 Policy, held at Vigyan Bhavan in New Delhi, Dr Singh emphasised the significance of strengthening Centre-State collaboration to advance India's bioeconomy. He highlighted the need for state governments to leverage their unique strengths, resources, and economic priorities to propel India’s biomanufacturing sector forward. Notably, he pointed out the importance of marine resources, the Himalayan region’s resources, and other region-specific bio-resources that could help usher in a new biotech revolution. Dr Jitendra Singh urged states to establish ‘BioE3 Cells’ in collaboration with the Centre through the Department of Biotechnology (DBT). These BioE3 Cells will serve as interconnected knowledge hubs, linking state and national stakeholders to facilitate the effective implementation of the BioE3 Policy. Established at the state level, these cells will act as central platforms for knowledge exchange, policy coordination, and technology adoption in the biomanufacturing sector. Dr Singh released a booklet on the Establishment of BioE3 Cells for Biomanufacturing Implementation, which aims to catalyze Centre-State partnerships to drive biotech innovations. In releasing the booklet, he highlighted that the primary goal of the BioE3 Cells is to ensure biomanufacturing initiatives are closely aligned with each state’s specific priorities, resources, and strengths, while also staying connected to broader national objectives. He emphasised that by establishing a nationwide network of BioE3 Cells, the government aims to facilitate the integration of emerging technologies, innovative research, and sustainable biomanufacturing practices across regions, ensuring a cohesive and efficient approach to biotechnology development in India. ]]> https://biospectrumindia.com/news/22/25613/india-to-expand-global-medtech-share-to-10-12-by-2030.html https://biospectrumindia.com/news/22/25613/india-to-expand-global-medtech-share-to-10-12-by-2030.html Sat, 01 Feb 2025 00:00:00 +0530 MedTekon 2025, the flagship event of the Medical Technology Association of India (MTaI), recently convened policymakers, global dignitaries, investors, and healthcare leaders at Taj Palace, New Delhi. Focused on Investments, Reforms, and Synergies, the event set the agenda for policy acceleration, investment growth, and technological advancements in India’s MedTech sector. The event was graced by Chief Guest MAnupriya Patel, Union Minister of State for Health & Family Welfare and Chemicals & Fertilizers, and Guest of Honour Dr V. K. Paul, Member, NITI Aayog, who underscored the critical role of medical technology in shaping India’s healthcare future. While addressing the gathering, Anupriya Patel said, “It is an honour to inaugurate MedTekon 2025, a key platform uniting industry leaders, policymakers, and healthcare stakeholders to shape the future of India’s MedTech sector. With the industry poised to double its market size to $30 billion by 2030 and expand its global share from 1.65% to 10-12%, India is rapidly emerging as a MedTech powerhouse. Our exports reached $3.8 billion last year, reflecting the sector’s growing manufacturing strength and global competitiveness. As we drive this momentum forward, collaborative efforts in innovation, investment, and policy reforms will be crucial to positioning India as a leader in affordable, high-quality medical technology.” In his remarks during the session on Catalysing Foreign & Domestic Investments in MedTech, Dr. V. K. Paul, Member, Niti Aayog said, “India’s 4,000+ health-tech startups need greater investment, regulatory support, and structured incubation to scale globally. Additionally, harmonising regulatory standards with global benchmarks is vital for investor confidence and sector growth. By focusing on innovation, investment, and policy stability, we can cement India’s role as a leader in affordable, high-quality medical technology." Pavan Choudary, Chairman, MTaI, emphasised the need for investment-friendly policies, regulatory coherence, and a robust MedTech infrastructure to support India’s growing healthcare needs. ble for de-humanization and a lot of stress, Mr. Choudary disagreed and highlighted, “The rise of communities like Hikikomori (term used in Japan) for those who prefer technology-driven interactions over human engagement as human interactions can lead to some level of stress and distress. Machines don’t judge and don’t tire and therefore are preferred by the many millions of hikikomories in the world today, whose number is soaring.”   A major focus area during the event was catalysing foreign and domestic investments, where stakeholders explored India’s potential as a global MedTech manufacturing and R&D hub. In the discussion on hospital technology integration, experts delved into the impact of AI, robotics, and digital health solutions on improving patient outcomes. Another key session on reimbursement policies examined the case to design health insurance for emerging needs. The regulatory panel addressed harmonising standards, reducing non-tariff barriers, and other aspects regarding regulatory and ease of doing business. The final session highlighted ethical marketing practices in MedTech and the need for skill development programmes to create a future-ready workforce capable of leveraging next-generation medical innovations. ]]> https://biospectrumindia.com/news/22/25614/union-budget-2025-lays-emphasis-on-cancer-care-medical-education-innovation.html https://biospectrumindia.com/news/22/25614/union-budget-2025-lays-emphasis-on-cancer-care-medical-education-innovation.html Sat, 01 Feb 2025 00:00:00 +0530 Union Minister of Finance and Corporate Affairs Nirmala Sitharaman presented the Union Budget 2025-26 in Parliament today, 1 February 2025. Laying emphasis on improving cancer care and treatment for millions in the country, the government has decided to set up Day Care Cancer Centres in all district hospitals in the next 3 years, with 200 centres coming up in 2025-26. "Organisations must now implement specialised staffing models, establish robust supply chain networks for cancer medications, and create integrated patient care pathways that connect primary care with specialised oncology services for successful implementation", said Joy Chakraborty, COO, P.D. Hinduja Hospital & Medical Research Centre, Mumbai. Professor Sarang Deo, Deputy Dean, Faculty & Research and Executive Director, Max Institute of Healthcare Management, ISB said, "A bigger need is to scale up cancer screening and diagnosis, the lack of which is resulting in patients being diagnosed at late stages with poor predicted outcome." As relief on import of Drugs/Medicines, 36 lifesaving drugs and medicines for treating cancer, rare diseases and chronic diseases have been fully exempted from Basic Customs Duty (BCD). Further, 37 medicines along with 13 new drugs and medicines under Patient Assistance Programmes have been exempted from Basic Customs Duty (BCD), if supplied free to patients. "The establishment of 200 cancer daycare centres in district hospitals represents a proactive move towards decentralising cancer treatment, making care more accessible. These centres will not only enhance accessibility but also improve outcomes by enabling timely interventions while customs duty exemptions on cancer drugs and 36 life-saving medicines will make critical treatments more affordable", said Dr Azad Moopen, Founder & Chairman, Aster DM Healthcare. Also, broadband connectivity will be provided to all government secondary schools and primary health centres in rural areas under the Bharatnet project. "We are especially excited to see the push for digital health infrastructure, like broadband connectivity for primary health centres under BharatNet. This will open doors for telemedicine, AI-driven diagnostics, and more efficient patient care—exactly the kind of innovation India needs to make quality healthcare available to all", said Ayush Jain, Founder & CEO of Mindbowser Inc.   Education & Innovation Highlighting new initiatives in the education sector, the government has stated that 10,000 additional seats will be added in medical colleges and hospitals next year, adding upto 75000 seats in the next 5 years. "Rs 99,858.56 crore has been allotted to Health Ministry, which is a 2% increase since the previous year and will focus on improving maternal and child healthcare under India's National Health Mission. The budget will also be used for improving healthcare infrastructure. The 2% increase is reflective of the Indian Government’s rising focus on Indian health. However, it may not be sufficient to increase medical seats for 10000 students by next year or to increase cancer daycare centers in district hospitals in the next 3 years, considering there will be continued focus on maintaining existing healthcare programmes", said Vandana Iyer, Research Director, TechVision, Frost & Sullivan. "The inclusion of 10,000 new seats in medical education this year, as well as 1.1 lakh UG and PG seats over the next ten years, is a positive step forward", said Dr Archana Dhawan Bajaj, Gynaecologist, Obstetrician and IVF Expert, Nurture IVF Clinic, New Delhi. "The government’s focus on increasing PG and UG in medical colleges, will improve the patient to HCP ratio and thereby the access and quality to care. These efforts are highly appreciated and we look forward to continued collaboration with the government to enhance healthcare access for all", said Shweta Rai, Managing Director for India and Country Division Head for South Asia, Bayer’s Pharmaceuticals. "Every additional seat also translates to the addition of four beds to the medical college and hospital. In five years, this initiative would add 300,000 more beds, nearly one-third of the current capacity in the public sector. The government may consider expanding existing medical colleges wherever possible to optimise expenditure", said Satyam Shivam Sundaram, Partner  Strategy & Transactions, Govt Advisory Services, EY. Sharing his concern over this development, Prof Dr Raj Nagarkar, MD & Chief of Surgical Oncology & Robotic Services, HCG Manavata Cancer Centre said, "The proposal to increase medical seats to 10,000 per year and 75,000 over five years, raises concerns. Expanding medical education must be accompanied by adequate infrastructure, trained faculty and a strong focus on maintaining the quality of education. Simply increasing numbers without addressing these factors could dilute the training and preparedness of future doctors." Further, a Centre of Excellence in Artificial Intelligence (AI) for education will be set up with a total outlay of Rs 500 crore. Additional infrastructure will be created in 5 Indian Institutes of Technology (IITs), started after 2014, to facilitate education for 6,500 more students. "By fostering advanced research, AI-enabled learning tools, and industry-academia partnerships, we are equipping the next generation with the skills needed to drive transformative change. This as a pivotal moment as we close the AI talent gap, ensuring that India is not just a consumer of AI but a creator of cutting-edge solutions", pointed out Mahesh Makhija, Technology Consulting Leader, EY India. Also, 50,000 Atal Tinkering Labs will be set up in government schools in the next 5 years, to encourage innovation. The Union Finance Minister has announced to set up five National Centres of Excellence for skilling with global expertise and partnerships to equip youth with the skills required for “Make for India, Make for the World” manufacturing. The partnerships will cover curriculum design, training of trainers, a skills certification framework, and periodic reviews. "The government’s initiatives, including the establishment of five major skill development centers, would help meet the target of 300,000 healthcare workers India aims to export annually", said Pavan Choudary, Chairman, Medical Technology Association of India (MTaI). While presenting the Budget, Nirmala Sitharaman announced to allocate Rs 20,000 crore to implement private sector driven Research, Development and Innovation. In the next five years, under the PM Research Fellowship scheme, provision of ten thousand fellowships for technological research in IITs and IISc with enhanced financial support is also proposed in the Budget. A “National Manufacturing Mission” to cover small, medium and large industries for furthering “Make in India” was also announced by the Union Minister for Finance and Corporate Affairs, Nirmala Sitharaman while presenting the Union Budget 2025-26. This will provide policy support, execution roadmaps, governance and monitoring framework for central ministries and states. "There has been an Increased Allocation for the Department of Biotechnology (DBT) in this year’s Budget to support Biomanufacturing, Biotech research, Entrepreneurship, innovation, skill development etc. DBT is perfectly positioned to contribute to the National Manufacturing mission for the development of biobased chemicals, enzymes, climate resilient crops, clean energy and various other sectors. DBT is also energising Center-State Partnerships in the Biomanufacturing sector to elevate the Indian Bioeconomy to new heights", highlighted Dr Rajesh Gokhale, Secretary, DBT. "Given the evolving geopolitical and geo-economic landscape and the intensifying competition for investments, it remains to be seen whether the Budget has done enough to strengthen our competitiveness, incentivise investments in high-tech sectors, and align with global best practices to position India as a preferred destination for capital and innovation", said Kiran Mazumdar Shaw, Executive Chairperson, Biocon. "In a major boost to private sector R&D, a Rs 20,000 crore has been allocated for Research Development & Innovation in the budget. Finance Minister in her budget speech of July 2024 had announced setting up Rs 1 lakh Crore R&D fund. The allocation this year will kick start the fund and will be a major boost to support R&D in private sector in deep tech and sunrise sectors. This will be a major step towards creating strategic autonomy in some key technology sectors. We are happy that DST will be the Nodal ministry driving this fund", said Abhay Karandikar, Secretary, Department of Science & Technology (DST). "The National Manufacturing Mission is set to strengthen India’s production capabilities, while the Centres of Excellence for skilling aim to cultivate a future-ready workforce. Moreover the investments in AI-driven education have the potential to accelerate healthcare innovation", said Nikhil Chopra, CEO & Whole Time Director, JB Pharma. "The government's commitment to advancing healthcare and building an integrated ecosystem for biotechnology is further reflected in the increased budget allocation for the Department of Biotechnology, rising from Rs 2,460.13 crore in 2024 to Rs 3,446.64 crore in 2025, an almost 40% increase. The budget also reflects a forward-looking investment strategy with ₹20,000 crore allocated for private-sector research, which should be strongly leveraged by the Pharma and biopharma sector to enable drug discovery and localised manufacturing", mentioned  Ankush Kapoor, CEO and Founder of PharmNXT Biotech. "We had hoped for a stronger push towards pharmaceutical R&D. Increasing allocation beyond the current 1% of GDP, raising the weighted tax deduction for R&D expenditure from 100% to 200%, and swiftly rolling out the Research Linked Incentive scheme remain critical to fostering drug innovation. We urge the government to consider these priorities to further bolster research in India’s pharma industry and healthcare ecosystem", said Saransh Chaudhary, President, Global Critical Care, Venus Remedies. Adding on, a national framework is to be formulated as guidance to states for promoting Global Capability Centres in emerging tier 2 cities. "The emphasis on fostering Global Capability Centers (GCCs) reinforces India’s role as a strategic hub for high-value innovation, R&D, and digital transformation. However, while these are positive steps, the budget leaves room for more robust healthcare reforms. Given the evolving healthcare needs of the country, greater investments and policy interventions are expected to ensure accessibility and innovation in medical technology", said Dhaval Radia, Chief Financial Officer (India), ZEISS Group.   Medical Tourism Union Budget 2025-26 has identified tourism as a sector for employment-led growth. Nirmala Sitharaman said that medical tourism and Heal in India will be promoted in partnership with the private sector along with capacity building and easier visa norms.  "The Heal in India initiative remains at the heart of India’s ambition to become a global hub for medical tourism. By fostering public-private collaboration, this initiative aims to enhance healthcare infrastructure, streamline patient care processes, and position India as a destination for world-class medical treatments at competitive costs", said Dr Manisha Bobade, CEO, K J Somaiya Hospital & Research Centre. "The government’s focus on medical tourism and 'heal in India' initiative, with relaxed visa norms and private sector collaboration, will strengthen India’s position as a global healthcare destination. To capitalize on this, investment in infrastructure, quality care, and seamless patient experiences must be prioritized, ensuring India remains competitive in the international healthcare market", said Behram Khodaiji, CEO, Ruby Hall Clinic, Pune. "The Union Budget 2025 aims at capturing a fair share of the international medical tourism market while addressing the challenges of healthcare delivery and medical education.  Strengthenin Medical Value Travel is important with the increasing competition from countries like Turkiye, Thailand & Malaysis who all are vying to increase their share from the same pie", said Dr SC Nagendra Swamy, President , Ramaiah Memorial Hospital. "By strengthening the ‘Heal in India’ and ‘Heal by India’ initiatives, the government is fostering an ecosystem where Indian healthcare can meet global demand while ensuring quality care at home. With these strategic initiatives , India is not just preparing for the healthcare challenges of today but laying the foundation for a resilient, future-ready health economy", said Sindoori Reddy, Director - Strategy, Apollo Hospitals. "India needs to become the world’s medical tourism capital for forex inflows, increased employment opportunities, increasing local bio-medical equipment manufacturing, etc. The budget has now made the “heal in India” programme more friendly by making it easier for VISAs, and allocating funds from the Rs 20,000 croresof the PM Gati Shakti Project where the private sector will also be involved", said Dr Rajeev Boudhankar, Medical director, Holy Family Hospital, Bandra, Mumbai.   Industry expects more While the Union Budget 2025 – 26 continues to build upon India’s growth story within the healthcare sector, there are a few areas lying untouched where the industry seeks the government's attention. For instance, Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD), on behalf of the medical devices industry, expressed disappointment over the fact that there is no mention of any investment promotion measures for the imports dependent sector in the main speech and had hoped that there will be some measures to boost the sector in the fine print. He said, “The Industry is disappointed that expectations of the Medical Devices sector and many of which had been supported by Dept of Pharmaceutical too as an investment enabler under the National Medical Device 2023 policy finds no mention in the speech. We were hoping to see the finance minister speak about Medical Devices as make in India enabler and address the 70% import dependence due to inadequate tariff protection with duties at zero to 7.5% in most cases and an ever-rising imports bill that is expected to cross Rs 75000 crore this year." "The budget lays a strong foundation, critical areas like GST rationalisation in healthcare require urgent attention. Increasing the tax exemption for preventive health check-ups, extending benefits to multiple family members, and integrating outpatient diagnostics into insurance packages will significantly enhance affordability and encourage proactive health management. We look forward to continued dialogue and effective implementation to build a more resilient, inclusive, and future-ready healthcare system.”- Ameera Shah, Promoter and Executive Chairperson, Metropolis Healthcare. "We feel that the government should consider making some announcements for duty exemption on sight saving equipment and specialty eye care infrastructure as it can benefit an even larger population", said Dr Aditya Kelkar, Director, NIO Super Specialty Hospital. "While this budget is a commendable step forward, particularly in addressing the needs of cancer patients, we urge a similar focus on kidney-related diseases in future healthcare policies", said Prabhat Shrivastava- Promoter, Founder & CEO, VitusCare. "With 1 in 9 Indians at risk of cancer and most cases detected late, the budget should have prioritised prevention and early detection. A dedicated investment in vaccinations, awareness campaigns, and advanced screening technologies is essential to reducing cancer’s multi-level impact on individuals, families, and the economy", said Rakesh Menon, Founder & CEO, Previu Health. Jatin Mahajan, Secretary, Association of Diagnostics Manufacturers of India (ADMI) said, "Many aspects have not been touched on in the budget, and thus leave a lot of unfulfilled expectations such as the establishment of a separate regulatory body for medical devices distinct from pharmaceuticals. GST rates remain unchanged. We were looking forward to some aspect of rationalisation. Dedicated technology transfer grants for MedTech innovation are expected; and fast-track approval for new diagnostic technologies is the nedd of the hour." "No mention of extending the production-linked incentive (PLI) scheme to Contract Research and Manufacturing Services or simplifying regulatory processes like Advance Pricing Agreements (APA) leaves scope for further policy refinements", said Nikkhil K Masurkar, CEO, Entod Pharmaceuticals. "In the coming years, we expect government to focus more on primary healthcare and improved diagnostics to curb the burden of rising Non Communicable Diseases", said Aditya Kandoi, CEO and Founder of Redcliffe Labs. "While the government’s efforts to expand healthcare access are commendable, we hope that future budgets will also prioritise reproductive health, ensuring that every family has the opportunity to grow and thrive", said Dr Sheetal Jindal, Senior Consultant and Medical Director; Director at Medical Genetics Programme, Jindal IVF Chandigarh.   "As we look ahead, further targeted initiatives such as the integration of mental health into primary healthcare, insurance coverage for mental health, and investments in early intervention programmes for neurodevelopmental disorders must remain priorities to truly revolutionise the mental health framework”, said Tarun Gupta, Co-Founder at Lissun.   "While the budget includes a few positive measures, it fails to drive real healthcare development. The lack of adequate funding, low insurance claim limits, and high taxation on medical necessities continue to hinder the sector’s growth. A more comprehensive, long-term strategy is required to truly uplift healthcare in India", said Dr V P Chandrasekaran, COO,  SRM Global Hospitals. ]]> https://biospectrumindia.com/views/22/25605/pre-budget-dialogue-industry-leaders-on-indias-economic-healthcare-priorities.html https://biospectrumindia.com/views/22/25605/pre-budget-dialogue-industry-leaders-on-indias-economic-healthcare-priorities.html Wed, 29 Jan 2025 00:00:00 +0530 With the Union Budget 2025 on the horizon, BioSpectrum India hosted a pre-budget session virtually led by CEO Manasee Kurlekar, featuring esteemed industry leaders Dr. rer. nat. Nagaraj Rao, Managing Director of Rane Rao Reshamia Laboratories Pvt Ltd, and Dr. Chandrashekharan S, Chairman & Managing Director of Vipragen Biosciences The discussion focused on India’s GDP trajectory, innovation-driven biotech growth, healthcare infrastructure, talent retention, and policy expectations from the upcoming budget. India’s GDP Growth & Competitive Landscape Kicking off the session, Dr. Nagaraj Rao provided an economic outlook, stating that India’s GDP growth is projected between 6% to 7.5% in 2025. He highlighted that while India benefits from a robust domestic market, state-wise GDP disparities persist, with states like Assam achieving an impressive 19.1% growth rate. He noted that China’s aggressive industrial strategy and government-backed infrastructure investments have given it an edge in biopharma and green energy sectors. He emphasized that India's approach should not rely solely on government support but must involve industry-led initiatives to improve industrial parks, utilities, and supply chain resilience. Key Takeaway: India must accelerate infrastructure and industrial growth to reduce dependency on China and compete globally. Healthcare & Life Sciences: Government Intervention Needed Dr. Chandrashekharan S addressed the post-pandemic healthcare priorities, emphasizing India’s rapid biopharma advancements but also the gaps in innovation, funding, and ecosystem support. He pointed out that while India has made strides in life sciences, biotech manufacturing, and research incubation, a structured innovation framework is still lacking. To compete with global leaders, India must focus on: Expanding biotech clusters to facilitate deep-tech startups and academic collaborations. Strengthening regulatory and financial support for startups scaling from R&D to commercial production. Enhancing tax incentives for companies investing in biotech R&D. Reducing intellectual property (IP) registration costs to help startups retain ownership of their innovations globally. Key Takeaway: India must bridge the gap between innovation and commercialization through regulatory reforms, IP protection, and financial support. Addressing the Talent & Retention Crisis Both speakers agreed that India faces a critical talent shortage in life sciences and technology-driven sectors. Dr. Rao noted that while India produces world-class researchers, many leave for better opportunities abroad due to lack of career stability and funding. He emphasized the need for: Industry-academia partnerships to ensure practical training beyond theoretical education. Government-backed talent retention programs to incentivize skilled professionals to stay in India. Mentorship and long-term career planning to prevent high attrition rates among biotech professionals. Key Takeaway: Building a strong innovation ecosystem requires nurturing and retaining talent through better education, funding, and career support. Digital Transformation in Biotech & Pharma In discussing digital advancements in healthcare and pharma, Dr. Chandrashekharan highlighted that AI, ML, and data-driven diagnostics are reshaping the industry. However, he warned that without significant investment in AI-driven R&D, India risks lagging behind. The government must support digital infrastructure development to ensure competitiveness in drug discovery, clinical research, and precision medicine. Key Takeaway: The budget should prioritize AI-driven biotech R&D, digital infrastructure, and smart manufacturing capabilities. Expectations from the 2025 Budget Both Dr. Rao and Dr. Chandrashekharan shared their wishlist for the upcoming budget: Regulatory Simplification: Extend DCGI license validity from 3 to 10 years to reduce bureaucratic burdens on pharma companies. IP Protection: Government subsidies for patent filing and IP maintenance to help startups compete globally. Biotech Scale-Up Support: Debt funding and tax incentives for biotech firms transitioning from R&D to commercial production. Medical Device Manufacturing: Encourage domestic production through policy integration between engineering, design, and regulatory approvals. Talent Development & Retention: Provide tax benefits and grants for companies investing in long-term employee training. Final Thoughts: A Future-Ready Budget? As the session concluded, Dr. Rao raised concerns over India’s high startup failure rate, with only 30 out of 1,400 biotech startups successfully scaling up. He emphasized the need for targeted financial assistance and mentorship programs to prevent wasted potential. Both speakers agreed that while India has taken significant steps in pharma, biotech, and medical device innovation, the upcoming budget must provide long-term structural support to sustain growth. With the Union Budget 2025 just around the corner, industry stakeholders await critical policy decisions that could shape India's trajectory as a global biotech leader.   Click here to Watch Session Recording         ]]> https://biospectrumindia.com/news/22/25570/bharuch-bulk-drugs-park-to-be-completed-by-first-half-of-2026-gujarat-fdca-commissioner.html https://biospectrumindia.com/news/22/25570/bharuch-bulk-drugs-park-to-be-completed-by-first-half-of-2026-gujarat-fdca-commissioner.html Tue, 21 Jan 2025 00:00:00 +0530 Gujarat Food and Drugs Control Administration (FDCA) Commissioner Dr H G Koshia has confirmed that the Bulk Drugs Park in Bharuch is on track for completion in the first half of 2026, with construction in advanced stages. The ambitious project is part of the Central government’s "Promotion of Bulk Drug Parks" scheme and is expected to significantly boost India’s self-reliance in active pharmaceutical ingredients (APIs). Dr Koshia stated that critical infrastructure developments, including electricity and other essential facilities, are progressing rapidly. The Gujarat government has allocated 800 acres for the park in Jambusar, which is expected to attract large-scale investments from domestic and international pharmaceutical companies. Under the "Promotion of Bulk Drug Parks" scheme, the Central government has committed Rs 1,000 crore in financial grant-in-aid to develop key infrastructure. These include a common effluent treatment plant, a common solvent storage system, solid waste management, stormwater drains, and a safety and hazardous operations audit centre. Gujarat Industrial Development Corporation (GIDC), a wholly owned entity of the Gujarat government, has been designated as the State Implementing Agency (SIA) for developing the park at Jambusar.   The scheme also offers financial incentives based on sales of 41 selected pharmaceutical products, covering all 53 identified APIs. The incentives are structured as follows - Fermentation-based products: 20% incentive from FY 2023-24 to FY 2026-27, 15% for FY 2027-28, and 5% for FY 2028-29. Chemical synthesis-based products: 10% incentive from FY 2022-23 to FY 2027-28. By offering these incentives, the government aims to attract significant investments and strengthen domestic production of essential APIs. Gujarat continues to be a dominant force in India’s pharmaceutical industry, accounting for 28% of the country’s total pharma exports, valued at $25 billion. The state also contributes 30-31% of India’s domestic pharmaceutical market, also pegged at  $25 billion. However, the sector has faced challenges due to rising input costs over the past one and a half years. The completion of the Bulk Drugs Park in Bharuch is expected to mitigate these challenges by providing a world-class manufacturing ecosystem.   Bhagwati Prasad   ]]> https://biospectrumindia.com/news/22/25523/government-strengthens-healthcare-delivery-in-assam.html https://biospectrumindia.com/news/22/25523/government-strengthens-healthcare-delivery-in-assam.html Wed, 08 Jan 2025 20:00:00 +0530 Union Minister of Health and Family Welfare, Jagat Prakash Nadda visited key healthcare facilities in Assam, including the Lokopriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH), Mangaldai District Civil Hospital, and AIIMS Guwahati, to inaugurate new initiatives and review ongoing healthcare projects aimed at enhancing medical services for the people of the region During his visit to LGBRIMH in Tezpur, the Union Health Minister inaugurated the institute’s new Library and Informatics Centre. Expressing his satisfaction with the institute’s growth, Nadda emphasised the need to introduce more super specialty departments to better serve the Northeast and the nation as a whole. Nadda also visited Mangaldai District Civil Hospital in Darrang district, where he laid the foundation stone for a state-of-the-art 50-bedded Critical Care Block (CCB). The CCB, to be constructed with a financial support of Rs 23.75 crore under Pradhan Mantri - Ayushman Bharat Health Infrastructure Mission, will significantly improve access to advanced healthcare services for the people of Assam. During his visit to Darrang, Nadda also inspected ongoing treatments at the cancer hospital and visited a cancer care project under Tata Trusts. He remarked, “Earlier, people had to travel out of state for cancer treatment, but now, the people of Darrang can receive their treatment right here at home.” ]]> https://biospectrumindia.com/news/22/25510/oppi-seeks-policy-level-clarifications-for-reducing-treatment-costs-from-budget-2025.html https://biospectrumindia.com/news/22/25510/oppi-seeks-policy-level-clarifications-for-reducing-treatment-costs-from-budget-2025.html Fri, 03 Jan 2025 00:00:00 +0530 "To strengthen India's healthcare ecosystem and drive inclusive growth, the upcoming budget must prioritize increased public spending on health initiatives. This includes expanding coverage under the Ayushman Bharat scheme to missing middle, upgrading existing Centers of Excellence, establishing new ones, and enhancing primary healthcare infrastructure. Policy-level clarifications, such as expanded exemptions for life-saving drugs and oncology medications from import duty are vital for reducing treatment costs. Simplifying Advance Pricing Agreement (APA) procedures, including timelines for swift case resolution, sharing APA authorities’ search processes for better negotiations, and ensuring timely renewals without procedural redundancies, will also help improve efficiency and ease of doing business.  Furthermore, expansion of the scope of section 115BAB of the Income Tax Act, 1961 to companies solely engaged in pharmaceutical R&D and providing a 200% deduction rate on R&D expenditures will encourage innovation in the pharma space. Also, mandatory timelines for disposing of appeals particularly by the Income Tax Appellate Authorities and removing turnover criteria for safe harbor provisions for R&D will also encourage innovation and investment. These recommendations are essential to build a robust, equitable, and patient-focused healthcare framework for India’s future." Anil Matai, Director General, Organisation of Pharmaceutical Producers of India (OPPI) ]]> https://biospectrumindia.com/features/22/25490/telanganas-bid-to-achieve-positive-investment-growth.html https://biospectrumindia.com/features/22/25490/telanganas-bid-to-achieve-positive-investment-growth.html Tue, 24 Dec 2024 00:00:00 +0530 Telangana state overcoming various hurdles and challenges is rapidly strengthening its position as a global leader in the life sciences and Active Pharmaceutical Ingredients (API) sectors. In the past year from November 2023 to December 2024, the state government succeeded in attracting investments worth Rs 36,000 crore and Rs 5,260 crore in life sciences and API sectors respectively.  With over 140 projects in the pipeline, these investments in the life sciences sector are set to generate 51,000 direct jobs and an additional 1,50,000 indirect jobs, showcasing the state’s exceptional growth trajectory in the coming days ahead. Speaking on this remarkable achievement, Telangana's Industries and Commerce Minister, Duddilla Sridhar Babu, emphasised the state’s proactive policies and strategic vision. "Telangana has emerged as the epicentre for global life sciences innovation. This momentum includes both significant investments from new entrants and additional investments by existing companies that recognise the value of expanding in Telangana. This is a testament to the business-friendly approach of our government and the strong ecosystem we have built over decades," Babu stated.   Genome Valley: At the Heart of Innovation The cornerstone of Telangana’s success in the life sciences sector lies in Genome Valley, India’s first and largest R&D cluster. This hub continues to attract global industry leaders, driving significant investments and expansions. Over the past year, Genome Valley has witnessed remarkable developments, solidifying its reputation as a global innovation centre for pharmaceuticals and biotechnology. Among the key investments, KrKA (Europe) and Laurus Labs jointly committed Rs 2,000 crore to establish state-of-the-art facilities for pharmaceutical finished products and biopharmaceutical manufacturing. In addition, Laurus Labs inaugurated a cutting-edge R&D centre with an investment of Rs 250 crore, creating employment opportunities for 2,800 people. In a noteworthy partnership, Takeda (Japan) collaborated with Biological E to manufacture 5 crore doses of the dengue vaccine annually. This initiative has further reinforced Hyderabad’s reputation as the Vaccine Capital of the World. Another milestone was achieved with Rx Propellant and Terminus Group announcing a Rs 2,000 crore investment to develop 20 lakh square feet of world-class laboratory space within Genome Valley, expected to generate 10,000 new jobs. Additionally, the Telangana government partnered with Thermo Fisher Scientific, which plans to establish the country’s first scale-up biological manufacturing facility and bioprocess design centre in Genome Valley, marking another significant breakthrough for the region. Adding to this momentum, Miltenyi Biotec from Germany is setting up a world-class Cell and Gene Therapy facility, enhancing Hyderabad’s global profile in advanced medical research. Meanwhile, Aragen, one of India’s leading Contract Research and Development/Manufacturing Organizations (CRO/CDMO), has announced a Rs 2,000 crore expansion plan in Nacharam, which will create 1,000 new jobs and further strengthen its presence in Telangana. Other notable investments include expansions by global players such as Switzerland-based Ferring Pharma, Germany-based DFE Pharma, and USA-based Vivint Pharma, all of which are bolstering their operations in Genome Valley. These investments collectively underline Telangana’s rising prominence as a global leader in life sciences and innovation.   Global Capability and Innovation Centers In addition to manufacturing facilities, Hyderabad is rapidly emerging as a preferred destination for Global Capability and Innovation Centers (GCICs), attracting leading companies from across the world. Over the past year, several prominent announcements have highlighted the city’s growing importance as a hub for innovation and technology. Amgen, a global biotechnology leader, is establishing one of its largest innovation centres worldwide in Hyderabad. This facility, designed to accommodate 3,000 employees, underscores the company’s ambitious expansion plans in the region. Similarly, Zoetis, the world’s largest animal health company, recently inaugurated a cutting-edge technology and innovation centre in the city, further enhancing Hyderabad’s reputation as a centre for excellence in research and innovation. Adding to the momentum, Olympus, a Japanese medical technology giant, is setting up an engineering and R&D centre in Hyderabad. This facility is expected to employ around 500 people, driving advanced medical technology solutions. Meanwhile, HCA Healthcare, America’s largest healthcare systems provider, is building a large campus in the city to bolster its operational capabilities. In another significant development, Cigna, a Fortune 16 health services provider, is expanding its presence in Hyderabad through its subsidiary, Evernorth Health Services. The company is setting up a massive campus in the city, reinforcing its commitment to innovation and customer-focused solutions. Hyderabad’s growing appeal has also drawn investments from companies such as ModMed from Canada and RxBenefits from the USA, among others. These developments further highlight the city’s transformation into a global hub for innovation, driven by world-class infrastructure and a thriving ecosystem for research and development. Telangana’s growth is not limited to new entrants. In the past year, existing industry giants like Medtronic, which established its first IT centre outside the USA in Hyderabad with a Rs 500 crore investment, continue to scale up their operations. Companies such as Sanofi, Bristol-Myers Squibb (BMS), and Providence are further expanding their already significant presence, demonstrating their confidence in Hyderabad’s business ecosystem. As Hyderabad continues to attract new investments and foster innovation, the city is poised to remain at the forefront of the global life sciences industry. From cutting-edge R&D facilities to large-scale manufacturing and innovation hubs, Hyderabad is setting benchmarks that underscore its status as a world-class destination for life sciences. Expressing satisfaction with the city’s ability to attract and retain major players in the life sciences sector, the Minister said, “We are proud to see Hyderabad emerging as a global hotspot for life sciences innovation. The continued investments and expansions by industry leaders reaffirm the trust in Telangana’s robust infrastructure and business-friendly policies.”    New Life Sciences Policy on the Horizon Telangana’s strategic focus extends to the intersection of life sciences and technology. Hyderabad, with its deep talent pool in pharmaceuticals, biotechnology, artificial intelligence, and digital health, has become a prime destination for Global Capability Centers (GCCs) in healthcare and life sciences. The state government has launched a Life Sciences GCC Consortium to power curriculums of science courses with technologies such as Artificial Intelligence (AI). At present, 40 life sciences companies are the members of the consortium. The course designed by the consortium will support science students to secure jobs at GCCs.  The Minister noted that the course will be introduced based on a hybrid model. Firstly, GCC companies like Dr. Reddy’s Laboratories will undertake training related to their vertical at the Young India Skills University, secondly, these GCCs will connect with the Skills University for training in new niche areas, and thirdly, a subject will be introduced in the curriculum of colleges. "Hyderabad has created a niche for itself as the hotspot for GCCs, attracting investments across the life sciences and healthcare value chain, including pharma, biotech, medtech, and health insurance," said Jayesh Ranjan, Principal Secretary, Industries, Government of Telangana.  The state is preparing to launch a dedicated life sciences policy, aimed at streamlining processes, fostering innovation, and driving sustainable growth in the sector. "This policy will further consolidate Telangana’s position as a vital node in the global life sciences value chain," added Ranjan, highlighting the government’s commitment to building a robust and inclusive ecosystem.   Strategic Initiatives and Investments   With Telangana already a strong base for bulk drugs and Active Pharmaceutical Ingredient industries, the state contributes more than 30 per cent of India’s total API exports. Telangana plays a crucial role in India's API manufacturing landscape, contributing significantly to both domestic production and exports. With its strategic initiatives and continued investment in infrastructure and talent development, the state is poised to enhance its position further in the global pharmaceutical supply chain.  While Telangana has witnessed massive investments in the life sciences segment, the chemical, API, and bulk drug industries have experienced a similar surge. In the past year, several API manufacturing companies in Hyderabad have expressed plans to set up new units and expand existing facilities.  In November 2024, representatives of top pharma companies who met Chief Minister Revanth Reddy, signed a Memorandum of Understanding (MoU) with the state government, pledging investments into new Greenfield industrial clusters to the tune of over Rs 5260 crore in the state. Top investors from the API industry include Dr. Reddy’s Labs, Laurus Labs, Gland Pharma, MSN Laboratories and Hetero Group. These companies, apart from expressing their intent to invest, have also promised to employ over 12,500 people in the state. Confirming this, Satish Reddy, Chairman of Dr. Reddy’s Laboratories, said, “Our recent meeting with the Chief Minister had been positive. The state government is eager to expand the pharmaceutical sector in the rural areas. Accordingly, an MoU has been signed with the government to set up new units and expand existing facilities in the proposed upcoming Greenfield industrial areas.”    Overcoming Challenges Earlier plans for the Integrated Hyderabad Pharma City faced delays due to legal disputes and protests over land acquisition. The new government’s decentralised strategy aims to balance regional development while mitigating challenges. IT and Industries Minister Sridhar Babu stated, “We are identifying land along the ORR with infrastructure for Greenfield Pharma clusters, ensuring balanced regional growth.” While the state is witnessing significant growth and new investments in the pharmaceutical sector on one hand, it is also grappling with challenges in land acquisition for setting up these projects. For instance, as part of the state government’s plan to establish a Pharma Industrial Cluster in the Kodangal region, it faced strong resistance from the local population. One notable incident occurred in Lagacherla village, where a public hearing organised to seek consent for acquiring 1300 acres of land from farmers turned violent. During the meeting, residents attacked the district collector and other officials, expressing their opposition to the proposed Pharma Industrial Corridor. As a result of this fierce backlash, the state government was forced to cancel the proposal for the Pharma corridor and instead proposed setting up an industrial cluster. Even though the pharma industry has witnessed ups and downs, over the past many years in Telangana, with proactive industry policies, initiatives and measures from the state government, Hyderabad remains a global hub for generic pharmaceuticals and vaccines. With India’s pharma market projected to reach $120–130 billion by 2030, Telangana plays a pivotal role in advancing global healthcare solutions.   Amguth Raju hyderabad@mmactiv.com ]]> https://biospectrumindia.com/news/22/25487/nathealth-seeks-fund-to-support-rd-and-reward-for-medtech-innovation-more-in-budget-25-26.html https://biospectrumindia.com/news/22/25487/nathealth-seeks-fund-to-support-rd-and-reward-for-medtech-innovation-more-in-budget-25-26.html Mon, 23 Dec 2024 00:00:00 +0530 NATHEALTH, Healthcare Federation of India, has laid out a bold and strategic framework to reshape the future of India’s healthcare ecosystem. In its recommendations, NATHEALTH urges the Finance Minister to prioritise significant financial commitments in the 2025-26 Budget to address the growing burden of communicable and non-communicable diseases, compounded by longstanding challenges, in alignment with the vision for "Viksit Bharat 2047." NATHEALTH seeks announcement of a fund to support R&D and reward med-tech innovation in India (including GCC’s) while transitioning to quality linked standardised procurements norms towards value-based care. Further, NATHEALTH's recommendations call for a significant increase in healthcare budget allocation to over 2.5% of GDP, with a focus on the following key areas- Reducing Cancer Care Costs: Remove customs duties and reduce GST to 5% on oncology radiation equipment, such as LINACs, to expand cancer treatment capacity in underserved regions Redirecting Public Health Revenues: Allocate proceeds from healthcare CESS and the proposed 35% GST slab on tobacco and sugar products to strengthen public health programmes. Advocate for a unified 5% GST on all healthcare goods and services to reduce input costs Encouraging Vertical Expansion of Hospitals: Permit hospital heights up to 60 metres nationwide (from the current limit of 45 metres), supported by funding for fire safety upgrades to ensure compliance in high-rise healthcare facilities Strengthening Health Infrastructure: Add 2.5–3.0 million hospital beds nationwide through Viability Gap Funding (VGF) and long-term, low-interest capital investments, fostering participation from mid-sized and smaller healthcare providers Viable Insurance Reimbursement Rates: Index reimbursement rates under schemes such as CGHS, PMJAY, and ECHS to the Consumer Price Index (CPI) to ensure financial viability, given that many rates have remained unchanged for nearly a decade Expanding Medical Education: Increase MBBS and postgraduate medical seats through government-led investment, supported by alternative financing mechanisms such as loans and interest subventions. Increase tuition fees for private DNB programmes by 75%-100% to fund capacity expansion Advancing Digital Health: Launch a 10-year digital health incentive plan to enable the adoption of Ayushman Bharat Digital Mission (ABDM) infrastructure, enhance data security, implement electronic health record (EHR) systems, and upskill technical resources. Foster collaboration between industry, academia, and start-ups to drive digital innovation Promoting India as a Healthcare Hub: Establish a dedicated fund to position India as a leader in high-quality healthcare and medical tourism, with targeted investments in critical and holistic health services   ]]> https://biospectrumindia.com/news/22/25455/india-to-scale-up-digitalisation-of-ayurveda-ecosystem.html https://biospectrumindia.com/news/22/25455/india-to-scale-up-digitalisation-of-ayurveda-ecosystem.html Fri, 13 Dec 2024 00:00:00 +0530 The 10th World Ayurveda Congress (WAC 2024) and Arogya Expo were inaugurated on 12 December in Dehradun, in the presence of the Union Minister of State (Independent Charge), Ministry of Ayush Prataprao Jadhav; Chief Minister, Uttarakhand Pushkar Singh Dhami; Secretary, Ministry of Ayush, Vaidya Rajesh Kotecha and Dr Shekhar Mande, President,Vijnana Bharati. Prataprao Jadhav, Union Minister of State, Independent Charge, Ministry of Ayush, in his address said that thousands of minds are gathered here to discuss digital health. This marks 10th World Ayurveda Congress (WAC) a pivotal juncture where various streams of ideologies, cultures, and innovations converge. Ayush Secretary Vaidya Rajesh Kotecha (as seen in the image) said that the country is well on its track in the implementation of the 2030 Agenda for the sustainable development of Ayurveda ecosystem based on digital health concepts aimed at achieving the goal of equity in health and wealth with scalability. Vaidya Rajesh Kotecha further said that we have Tech-enabled solutions now with Ayush Grid, as it revolutionises healthcare with innovations, enhancing effectiveness, safety, and affordability. He also added, “more than 1.3 billion dollar investment is in pipeline from global partners.” As stated by the organising officials, for the 4-day event, more than 5500 Indian delegates and over 350 delegates from 54 countries have registered to participate in the mega event. The event will feature over 150 scientific sessions and 13 associate events besides plenary sessions. The central theme for the WAC2024 is, "Digital Health: An Ayurveda Perspective," to delve into the transformative potential of modern technologies in advancing Ayurveda. The event includes in-depth discussions and knowledge sharing on leveraging cutting-edge digital tools and innovations to enhance healthcare delivery, redefine research, and integrate Ayurveda into the rapidly evolving global health landscape. The event also features technical sessions, panel discussions, plenary and scientific sessions, an international delegates assembly, a health ministers’ conclave, an investors’ meeting, and satellite seminars. The deliberations will also focus on Ayurveda solutions for diverse healthcare challenges of modern day. The Ministry of Ayush is instrumental in organising the World Ayurveda Congress, underscoring India’s commitment to promoting Ayurveda on the global stage. ]]> https://biospectrumindia.com/news/22/25364/one-day-one-genome-initiative-to-harness-microbial-potential-of-india.html https://biospectrumindia.com/news/22/25364/one-day-one-genome-initiative-to-harness-microbial-potential-of-india.html Tue, 19 Nov 2024 00:00:00 +0530 The Department of Biotechnology (DBT) and Biotechnology Research and Innovation Council (BRIC) has introduced the 'One Day One Genome' initiative to showcase the enormous microbial potential of India. Amitabh Kant, India’s G-20 Sherpa and Former CEO NITI announced the launch of ‘One Day One Genome Initiative’ on the 1st foundation day of BRIC held in National Institute of Immunology (NII), New Delhi on 9th November 2024 'One Day One Genome’ initiative will highlight the unique bacterial species found in our country and emphasise their critical roles in environment, agriculture and the human health.  Genome sequencing will allow the visualisation of the hidden potential of the microbial world to the community at large. Sequencing data can be analysed to identify the genome encoded capacities for various important enzymes, antimicrobial resistance, bio active compounds etc. Research in this field will lead to the benefit of better protection and management of our environment, development in agriculture and improvement in human health. This initiative coordinated by Biotechnology Research and Innovation Council-National Institute of Biomedical Genomics (BRIC-NIBMG), an institute of the Department of Biotechnology. This initiative aims a release a fully annotated bacteriological genome isolated in the country freely available to the public. This will be complemented with a detailed graphical summary, infographics and genome assembly/annotation details. These documents will thus give an idea about the scientific and industrial use of these microbes. Consequently, microbial genomics data will become more accessible to the general public, scientific researchers and thereby stimulate discussions; innovations directly benefit the entire community and ecosystem. ]]> https://biospectrumindia.com/news/22/25368/bengaluru-tech-summit-2024-witnesses-launch-of-indias-first-gcc-policy.html https://biospectrumindia.com/news/22/25368/bengaluru-tech-summit-2024-witnesses-launch-of-indias-first-gcc-policy.html Tue, 19 Nov 2024 00:00:00 +0530 The 27th Edition of Bengaluru Tech Summit 2024, organised by the Department of Electronics, IT, Bt, Government of Karnataka and Software Technology Parks of India, Bengaluru, was inaugurated by Siddaramaiah, Chief Minister of Karnataka and in the august presence of other dignitaries, at Bangalore Palace on 19th November. The event witnessed the launch of India's first policy for Global Capability Centre (GCC). Another key announcement was the launch of the Nipuna Karnataka Logo marking the beginning of a transformative skills initiative. Nipuna Karnataka aims at enhancing the skills of local talent to improve their global competitiveness in emerging technologies. The objective is to equip Karnataka’s workforce with advanced skills that align with the requirements of high-demand sectors, thus fostering economic growth and increasing employment opportunities both within and outside the state. It will aim to that the local talent is skilled locally and they work globally. Adding to the momentum, the government announced the establishment of a Centre of Excellence on AI in Bengaluru to foster cutting-edge research and development. Minister said, "Bengaluru Tech Summit 2024 showcases Karnataka’s leadership in innovation, sustainability, and inclusive growth. The launch of India’s first Policy for GCCs and the Nipuna Karnataka programme, aimed at skilling 100,000 individuals in cutting-edge technologies, reflects our commitment to empowering local talent and fostering global competitiveness. The Centre of Excellence in AI, in collaboration with IIT Alumni Center Bangalore, positions Karnataka as a hub for advanced R&D and startup innovation." As part of the Nipuna initiative, five strategic MoUs were exchanged with global tech giants —Microsoft, Intel, Accenture, IBM, and the BFSI Consortium— aiming to bolster collaboration and drive innovation. These MoUs aim to train 1,00,000 trainees in the next year with a placement of 70% of the trained professionals. Another significant announcement was for Startup Springboard programme- a platform at BTS 2024, designed to empower Karnataka’s startups through three pillars; Investor Connect (linking startups with key investors and industry leaders); Mentor Connect (enabling invaluable guidance through mentor-mentee interactions) and Innoverse (providing infrastructure, plug-and-play facilities, and training to support prototype development and innovation for emerging entrepreneurs). BTS 2024, being held from 19 to 21 November, will feature a multi-stage conference across six tracks: IT, Deeptech & Trends, Biotech & Healthtech, Startup Ecosystem, Global Innovation Alliance, India-USA Tech Conclave, and the newly introduced Electro-Semicon track.   ]]> https://biospectrumindia.com/news/22/25360/telangana-emerges-as-global-life-sciences-hub-with-rs-36000-cr-in-investment-creating-51000-jobs.html https://biospectrumindia.com/news/22/25360/telangana-emerges-as-global-life-sciences-hub-with-rs-36000-cr-in-investment-creating-51000-jobs.html Fri, 15 Nov 2024 00:00:00 +0530 In a remarkable testament to Telangana’s growing prominence on the world stage, the state government announced unprecedented progress in the life sciences sector, securing over Rs 36,000 crore in investments from over 140 projects over the last year. These investments are set to create 51,000 direct jobs and an estimated 1,50,000 indirect jobs, solidifying Telangana's status as a powerhouse in the global life sciences industry. Duddilla Sridhar Babu, Minister of Industries and Commerce, Government of Telangana said, “We have witnessed a surge of investments from several international and domestic companies, who have chosen Telangana as their gateway to India's rapidly growing life sciences ecosystem. From pharmaceutical manufacturing and R&D centres to global capability centres (GCC) innovation hubs, these investments across the life sciences value chain make Telangana an undisputed leader in this space globally. This momentum not only includes significant investments from new entrants but also additional investments by companies that have already seen the value in expanding in Telangana. This is a strong indicator of their trust in present Government’s business friendly approach that we have championed over the last one year and the strong ecosystem built over the last 2-3 decades.” "We are also happy to share that we will shortly introduce a dedicated life sciences policy, which will further streamline processes, attract  investments, foster innovation, and drive sustainable growth across this critical sector,” he said. This upcoming policy is designed to address the evolving needs of the life sciences industry, ensuring Telangana consolidates its position as an important node in the global life sciences value chain. The past year has seen notable investments / expansions in and around Genome Valley-     European company KrKA and Laurus Labs announced a joint investment of Rs 2000 crore in Genome Valley to establish pharmaceutical finished products and biopharmaceutical manufacturing in the cluster. Additionally, Laurus inaugurated a  State-of-the-Art R&D centre with Rs 250 crore. Both these investments have a combined employment potential of 2800 people.     Japanese pharmaceutical major Takeda announced a partnership with Biological E to manufacture 5 Crore Dengue vaccine doses annually from Genome Valley. With this investment, Hyderabad will lead the global fight back against dengue, further cementing our position as the vaccine capital of the world.     Rx  Propellant  and  Terminus  Group’s  Rs  2000  crore  investment  in Genome Valley will create world class lab space infrastructure to the extent of 20 Lakh sft to support innovation and R&D, which has potential to create 10,000 new jobs across multiple functions     Government and Thermo Fisher have partnered together to establish the country’s first scale-up biological manufacturing facility and bioprocess design center in Genome Valley.      Germany based Milteyni Biotec is setting up a world-class Cell and Gene Therapy facility in Genome Valley.      Aragen – One of India’s leading CRO/CDMO announced a Rs 2000 crore expansion plan in Nacharam thereby doubling down on their strengths in Telangana and creating 1000 new jobs.   The state has seen massive success in attracting some of the most renowned global life sciences companies to Hyderabad-     World’s leading biotechnology company – Amgen is establishing an innovation centre, which is one of their largest centres worldwide, in Hyderabad. This centre can accommodate 3000 people and the company has very aggressive expansion plans.     Zoetis, the world’s largest animal health company inaugurated the technology and innovation centre     One of the world’s leading medical technology companies, Olympus headquartered in Japan, is establishing their engineering and R&D centre in Hyderabad with about 500 people.     Medtronic’s first IT center outside of USA, here in the city, with an investment of about Rs 500 crore. Companies like Sanofi, BMS, Providence, etc. are further expanding their already significant presence in Hyderabad. ]]> https://biospectrumindia.com/news/22/25334/govt-launches-scheme-for-strengthening-medical-device-industry.html https://biospectrumindia.com/news/22/25334/govt-launches-scheme-for-strengthening-medical-device-industry.html Sat, 09 Nov 2024 00:00:00 +0530 To provide a big boost to the medical devices industry, the Union Minister of Chemicals & Fertilizers and Health & Family Welfare, Jagat Prakash Nadda, has launched the Scheme for Strengthening the Medical Device Industry. Anupriya Patel, Union Minister of State for Chemicals and Fertilizers and Health & Family Welfare and Arunish Chawla, Secretary, Department of Pharmaceuticals along with officials of the department and representatives of industry were also present on the occasion. The scheme is a comprehensive one which targets critical areas of the medical device industry, covering manufacturing of key components and accessories, skill development, support for clinical studies, development of common infrastructure and industry promotion. The new scheme has a total outlay of Rs 500 crore. It consists of five sub-schemes which are as follows- Common Facilities for Medical Devices Clusters (Rs 110 crore); Marginal Investment Scheme for Reducing Import Dependence (Rs 180 crore); Capacity Building and Skill Development for Medical Devices (Rs 100 crore); Medical Device Clinical Studies Support Scheme (Rs 100 crore); and Medical Device Promotion Scheme (Rs 10 crore). Union Minister for Chemicals and Fertilizers appealed to the industry to make good use of the scheme and assured the industry of all help from the government stating that the Department is there to provide all support. Pavan Choudary, Chairman, Medical Technology Association of India (MTaI) said, "The scheme, launched after comprehensive research that included two groundbreaking stackathons, serves as a fine example of an evidence-based stimulation package. The efforts helped in identifying key areas where the industry needs support. This is where the scheme derives its focus on five critical aspects: manufacturing of essential components and accessories, skill development, support for clinical studies, development of shared infrastructure, and industry promotion." ]]> https://biospectrumindia.com/news/22/25299/govt-announces-launch-of-4-coes-at-niper-and-5-projects-under-pli-scheme-for-medical-devices-and-bulk-drugs.html https://biospectrumindia.com/news/22/25299/govt-announces-launch-of-4-coes-at-niper-and-5-projects-under-pli-scheme-for-medical-devices-and-bulk-drugs.html Tue, 29 Oct 2024 00:00:00 +0530 Prime Minister Narendra Modi laid the foundation stone of four Centres of Excellence (CoEs) at National Institute of Pharmaceutical Education and Research (NIPER) Ahmedabad in Gujarat for medical devices, NIPER Hyderabad in Telangana for bulk drugs, NIPER Guwahati in Assam for phytopharmaceuticals, and NIPER Mohali in Punjab for anti-bacterial anti-viral drug discovery and development. Also, in a major boost to Make in India initiative in the healthcare sector, Prime Minister inaugurated five projects under the Production Linked Incentive (PLI) scheme for medical devices and bulk drugs at Vapi in Gujarat, Hyderabad in Telangana, Bengaluru in Karnataka, Kakinada in Andhra Pradesh and Nalagarh in Himachal Pradesh. These units will manufacture high-end medical devices, such as body implants and critical care equipment, along with important bulk drugs. The Prime Minister mentioned that inauguration of these manufacturing plants would play a key role in manufacturing of advanced medicine and high quality stents and implants and further India’s growth. Prime Minister Narendra Modi also inaugurated the biggest Jan Aushadhi Kendra of the country at the All-India Institute of Medical Sciences (AIIMS), New Delhi. The main objective of this kendra is providing affordable and quality medicines to the patients visiting AIIMS for treatment of various ailments. ]]> https://biospectrumindia.com/news/22/25294/govt-unveils-five-pioneering-health-research-initiatives-for-medical-innovation.html https://biospectrumindia.com/news/22/25294/govt-unveils-five-pioneering-health-research-initiatives-for-medical-innovation.html Sun, 27 Oct 2024 00:00:00 +0530 Union Health Minister Jagat Prakash Nadda launched five Department of Health Research- Indian Council of Medical Research (DHR-ICMR) health research initiatives planned under the 100 days agenda. These initiatives aim to propel India to the forefront of global health research and innovation, aligning with the nation's vision of a Viksit Bharat. Addressing the occasion, JP Nadda remarked, "These groundbreaking initiatives exemplify our commitment to a healthier and more self-reliant India. By fostering indigenous innovation and investing in advanced research, we are equipping our nation to tackle pressing health challenges effectively." Dr Rajiv Bahl, Secretary DHR & DG ICMR said, “Initiatives like the 'First in the World' Challenge will empower our scientists and innovators to develop cutting-edge technologies that can benefit not just India but the entire world." One of the key initiatives launched is the "First in the World" Challenge, inspired by the success of Chandrayaan-3. This high-risk, high-reward research and development scheme is designed to foster the creation of health technologies that are unprecedented globally. The programme will fund projects at various stages from proof of concept design to prototype and final product development. Additionally, under the Pradhan Mantri – Ayushman Bharat Health Infrastructure Mission (PM-ABHIM), ICMR is upgrading existing Viral Research & Diagnostic Laboratories (VRDLs) to Infectious Disease Research and Diagnostic Laboratories (IRDLs). This enhancement includes bacteriology, mycology, and parasitology, expanding diagnostic capabilities beyond virology. These laboratories will strengthen India's capacity for comprehensive surveillance and rapid response to infectious diseases. ICMR also launched the ICMR Data Repository, a centralised, secure, and accessible platform of high-quality datasets, ensuring data integrity and privacy. The UNNATI Initiative (Upgrading Norms for Nutrition, Growth, and Development Assessment of Indian Children) aims to establish India-specific growth and development standards for children, addressing limitations of existing WHO benchmarks. Moreover, ICMR is initiating efforts to develop drugs for rare diseases, focusing on affordable and effective therapies for conditions such as Gaucher Disease, Sickle Cell Disease, and others. Ongoing projects range from clinical trials to animal studies and design phases, aiming to reduce dependence on imported treatments and improve accessibility for patients in India. ]]> https://biospectrumindia.com/news/22/25281/icmr-indiab-study-reveals-alarming-diabetes-prevalence-of-ut-of-jammu-and-kashmir.html https://biospectrumindia.com/news/22/25281/icmr-indiab-study-reveals-alarming-diabetes-prevalence-of-ut-of-jammu-and-kashmir.html Mon, 21 Oct 2024 00:00:00 +0530 The Indian Council of Medical Research (ICMR), in collaboration with the Madras Diabetes Research Foundation (MDRF), has released critical data from the ICMR-India Diabetes (ICMR-INDIAB) national study, which includes data for Union Territory of Jammu, Kashmir and Ladakh. The results of Jammu region are being presented. This first-of-its-kind study in the region reveals that the overall prevalence of diabetes in Jammu is 18.9%, with an alarming 26.5% in urban areas and 14.5% in rural areas. Additionally, 10.8% of the population is affected by prediabetes, emphasizing the urgent need for action against the growing burden of non-communicable diseases (NCDs) in the region. Dr. Jitendra Singh, Honourable Union Minister of State, described the ICMR-INDIAB study as a landmark initiative that provides the first representative epidemiological data on diabetes, prediabetes, hypertension, dyslipidemia, and obesity across India. The findings from Jammu will help estimate the health burden of diabetes and metabolic NCDs, assess diabetes control levels, and shift the focus toward prevention and management in the region. The ICMR-INDIAB study is a national survey aimed at providing reliable data on the prevalence of diabetes, hypertension, obesity, dyslipidemia, and other non-communicable diseases (NCDs) in India. Coordinated by the Madras Diabetes Research Foundation and supported by the ICMR-INDIAB Expert Group, this cross-sectional survey has been conducted from 2008 to 2024 across all 28 states, the NCT of Delhi, and 7 Union Territories. In Jammu, the survey covered 1,520 participants from urban and rural areas, offering valuable insights into the region's health landscape. Dr.V.Mohan, Chairman, Madras Diabetes Research Foundation and National Coordinator and Principal Investigator of the ICMR-INDIAB Study adds “I am very happy to inform you that the ICMR-INDIAB study has now been completed in all the 28 States, the National Capital Territory (NCT) of Delhi, and 7 Union Territories (UTs), including the islands. The total participants screened for diabetes and other metabolic disorders in all the phases of the study are 1,21,077, which makes it one of the largest epidemiological studies on diabetes ever done in the world.  The ICMR - INDIAB study which was conducted by the Madras Diabetes Research Foundation, with the help of ICMR and the Department of Health Research (DHR), showed that there were 101 million people with diabetes in India.  Dr. Rajiv Kumar Gupta, Professor & Head, Dept. of Community Medicine, Govt. Medical College, Jammu Region, says “The ICMR INDIAB study is the ‘first of its kind’ in Jammu to not only assess the burden of diabetes, and prediabetes but also to obtain information on other cardio-metabolic risk factors among 1,520 participants. The overall prevalence of diabetes in Jammu is 18.9%, while it is 26.5% in urban areas and 14.5% in rural areas. The overall prevalence of prediabetes is 10.8%, while it is 13.4% and 9.3% in the urban and rural areas, respectively. Forty percent of individuals had undiagnosed diabetes. The overall prevalence of hypertension, generalized obesity, abdominal obesity in Jammu is 27.1%, 41.7% and 62.7% respectively” Dr. Tanvir Kaur, Scientist ‘G’, Division of Non-Communicable Diseases, ICMR, New Delhi adds, “I wish to thank the present ICMR Director General and the previous DGs for supporting the ICMR-INDIAB study over the last 15 years throughout the country, making this the largest epidemiological study in the field of diabetes. The findings from this study are expected to help policymakers, health professionals, and stakeholders develop targeted interventions for the prevention and management of diabetes and other NCDs in Jammu and across India. ]]> https://biospectrumindia.com/news/22/25266/nppa-revises-ceiling-prices-of-eight-scheduled-drugs.html https://biospectrumindia.com/news/22/25266/nppa-revises-ceiling-prices-of-eight-scheduled-drugs.html Tue, 15 Oct 2024 00:00:00 +0530 The National Pharmaceutical Pricing Authority (NPPA) has been receiving applications from the manufacturers for upward revision of prices citing various reason like increased cost of Active Pharmaceutical Ingredients; increase in the cost of production; change in exchange rate etc.; resulting in unviability in sustainable production and marketing of drugs. Companies have also applied for discontinuation of some of the formulations on account of their unviability. After detailed deliberations in the full Authority meeting held on 8th October, 2024, invoking extraordinary powers under Para 19 of the DPCO, 2013, and in larger public interest, NPPA has approved increase in the ceiling prices of eleven (11) scheduled formulations of eight (8) drugs by 50% of their current ceiling prices. Most of these drugs are low-cost and generally used as first line treatment crucial to the public health programmes of the country. These drugs are used for treatment of Asthma, Glaucoma, Thalassemia, Tuberculosis, mental health disorders, etc. Formulations for which Ceiling prices have been revised include: Benzyl Penicillin 10 lakh IU injection; Atropine injection 06.mg/ml; Streptomycin powder for injection 750 mg and 1000 mg; Salbutamol tablet 2 mg and 4 mg and respirator solution 5 mg/ml; Pilocarpine 2% drops; Cefadroxil tablet 500 mg, Desferrioxamine 500 mg for injection; and Lithium tablets 300 mg. Earlier such extraordinary powers have been invoked by NPPA in 2019 and in 2021 whereby price of 21 and 9 formulations respectively were increased by 50% so as to ensure continued availability of essential drugs for the public. ]]> https://biospectrumindia.com/news/22/25261/india-hosts-19th-international-conference-of-drug-regulatory-authorities.html https://biospectrumindia.com/news/22/25261/india-hosts-19th-international-conference-of-drug-regulatory-authorities.html Mon, 14 Oct 2024 00:00:00 +0530 Jagat Prakash Nadda, Union Minister of Health and Family Welfare, inaugurated the 19th International Conference of Drug Regulatory Authorities (ICDRA), in New Delhi. The event which is being hosted for the first time in India, from 14th – 18th October by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, in collaboration with the World Health Organization (WHO) brought together regulatory authorities, policymakers, and health officials from over 194 WHO member states. The 19th ICDRA will emphasise strengthening global regulatory systems through partnerships and collective efforts. Regulatory authorities from various nations will discuss challenges and opportunities in harmonising regulations for medical products, addressing antimicrobial resistance (AMR), and advancing traditional medicines. Health Minister stated that more than 95% regulatory processes currently have been digitised at CDSCO, bringing transparency and increasing trust among stakeholders. He also stated, “Considering the importance of medical devices in healthcare delivery, Medical Device industry in India is also being regulated. Drugs Rules have been amended to make Good Manufacturing Practice Guidelines more comprehensive and at par with the WHO-GMP guidelines.” It was also pointed out that in order to make drug supply chain robust, it has been made mandatory to provide Bar Code or Quick Response Code (QR Code) on top 300 brands of drug products. Similarly, QR Code is mandatory on all API packs, either being imported or manufactured in India. Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India highlighted India’s achievements in drugs control and medical devices sector, including the approval of India’s first CAR T-cell therapy. “We are continuously upgrading our skills and capacities in our systems and are on a path towards low regulation and high execution”, he said. ]]> https://biospectrumindia.com/news/22/25224/cdsco-becomes-affiliate-member-of-international-medical-device-regulators-forum.html https://biospectrumindia.com/news/22/25224/cdsco-becomes-affiliate-member-of-international-medical-device-regulators-forum.html Thu, 03 Oct 2024 00:00:00 +0530 To achieve global alignment in its medical device regulatory system, enhance the competitiveness of the domestic industry, and boost transnational prominence, the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, applied for Affiliate Membership in the International Medical Device Regulators Forum (IMDRF) in 2024. After review of India’s application for Affiliate membership and meeting discussions by the IMDRF Management Committee (MC) with the senior officers of CDSCO during the 26thSession of IMDRF held in September 2024 at Seattle, Washington, USA, the CDSCO has received approval from IMDRF as an Affiliate Member of the Forum. The International Medical Device Regulators Forum (IMDRF), established in 2011, is a collaborative group of global medical device regulators dedicated to accelerating the harmonization and convergence of international medical device regulations. IMDRF members include national regulatory authorities from the United States, Australia, Canada, the European Union, Japan, the United Kingdom, Brazil, Russia, China, South Korea, Singapore, and the World Health Organization (WHO). Achieving Affiliate Membership in the IMDRF will provide significant opportunities for reliance and collaboration with regulatory authorities around the world. The membership helps to harmonise regulatory requirements across the globe, which reduces the complexity for manufacturers and helps in safeguarding public health by promoting collaboration, harmonizing regulations, and promoting convergence. It also helps to support innovation and timely access to new medical devices. As an affiliate member, India will participate in IMDRF Open Sessions to have information exchange on technical topics with other regulators, discussion on latest medical device regulatory strategies and trends, provide feedback on India’s experience and perspectives, use IMDRF documents in part or in whole as the basis for India’s regulatory framework for Medical Devices. This will strengthen the CDSCO’s medical device regulatory system, helping meet emerging technical challenges that are increasingly diverse, to ensure protection of public health and safety, and continue to maintain the goal of international recognition for its Medical Device regulation. This membership will enable Indian medical device manufacturers to meet the regulatory requirements of IMDRF member countries, thereby strengthening the "Brand India" in the global market. ]]> https://biospectrumindia.com/news/22/25205/karnataka-government-launches-draft-for-indias-first-dedicated-policy-for-global-capability-centres.html https://biospectrumindia.com/news/22/25205/karnataka-government-launches-draft-for-indias-first-dedicated-policy-for-global-capability-centres.html Sat, 28 Sep 2024 00:00:00 +0530 The Draft Global Capability Centre (GCC) Policy 2024-2029 has been launched by the Karnataka government.Key highlights include the creation of Global Innovation Districts with three new tech parks in Bengaluru and Beyond Bengaluru, and the establishment of a Centre of Excellence for artificial intelligence (AI) to boost AI R&D and talent development. The policy also introduces the Beyond Bengaluru Package, offering recruitment assistance and rental support, while creating 3.5 lakh jobs. The government aims to attract establishment of 500 new GCCs achieving a total number of 1,000 GCCs in Karnataka by 2029; To support creation of 3.5 lakh new jobs in Karnataka by 2029; and to generate economic output of $50 billion in Karnataka through the GCCs being established by 2029. The government is also announcing an Innovation Fund with an allocation of Rs 100 crore, to support joint research between GCCs and academia, and innovation challenges.  The government will set up a dedicated unit within the Department of Electronics, IT, Bt, and S&T to offer dedicated support for GCCs establishing operations in Karnataka. All necessary operational approvals for setting up GCCs will be processed within 45 days, ensuring a streamlined setup process that minimises delays and enhances investor confidence in Karnataka’s business-friendly environment. Global Capability Centres (GCCs) have significantly transformed the country's economic landscape. These centres have been instrumental in job creation, technology advancement, and skill enhancement; positioning India at the forefront of innovation and service delivery. As of March 2024, the GCCs in India generated annual revenues of $64.6 billion having grown at nearly double digits (~9.8%) between FY2019 and FY2024 . ]]> https://biospectrumindia.com/news/22/25185/government-of-meghalaya-signs-mou-with-bill-melinda-gates-foundation-to-improve-health-outcomes.html https://biospectrumindia.com/news/22/25185/government-of-meghalaya-signs-mou-with-bill-melinda-gates-foundation-to-improve-health-outcomes.html Wed, 25 Sep 2024 00:00:00 +0530 The Government of Meghalaya and the Bill & Melinda Gates Foundation (BMGF) made a major stride in the area of health when they entered into a Memorandum of Understanding (MoU) to work together towards improving population health outcomes of the state, particularly related to maternal and newborn health, family planning, nursing education. Meghalaya is only the third state in India in area of both health and agriculture, after Uttar Pradesh & Bihar, with whom the Gates Foundation is establishing a partnership. The MoU was signed in the presence of Chief Minister of Meghalaya, Conrad K Sangma and Minister of Health & Family Welfare and Agriculture, Dr M Ampareen Lyngdoh.  M. Hari Menon, Director of the India Country Office at the Gates Foundation, and Sampath Kumar, Principal Secretary to the GoM, Health & Family Welfare Department on behalf of the state signed the MoU.  The MoU signed called for the realisation of efficient and effective healthcare solutions in Meghalaya, and the parties also pledged to undertake numerous activities in the achievement of the United Nations Sustainable Development Goals, especially the health-related goal for the year 2030. The MoU will last for four years where both stakeholders shall facilitate successful delivery of the set objectives in the paper with efficiency checkups, monitoring, and evaluation. Through the MoU, BMGF will provide both financial and technical support to improve outcomes in twelve key areas: comprehensive primary healthcare, family planning, maternal health and anaemia, neonatal health, immunisation, childhood wasting and nutrition, nursing education, supply chain management, digital health, results-based financing and performance management in healthcare, competency mapping and development for government functionaries, and agriculture and livestock development. The collaboration between the Government of Meghalaya and the Gates Foundation is based on three strategically oriented goals for changing the current state of health care. First, it seeks to lower maternal, neonatal and child mortality through increasing access to family planning, managing anaemia and developing emergency transport to reduce death rates. Second, the partnership aims to promote health and nutrition services provided by government and non-government organisations with special reference to gender. Finally, the partnership will build the capacity of local institutions by ensuring that they are involved in policy formulation, research and breakthroughs in healthcare to support sustainable change. The partnership will also focus on several key programme areas, such as the creation of IT solutions for primary healthcare as well as improving family planning by increasing the number of contraceptive methods and availability. It will also involve enhanced maternal and neonatal health with reference to anaemia and other essential infrastructure joined to hidden childhood wasting and anaemia through supplementary feeding and immunisation. Also, nursing education shall be augmented by a redesigned curriculum that is globally competent and improved supply chain management to increase drug and diagnostics availability. Moreover, adopted digital health will improve research-based decision-making capabilities with the use of performance-based financing. There will also be cooperation in areas of agriculture and livestock development emphasizing building value chains and supporting small farmers in the state of Meghalaya.     ]]> https://biospectrumindia.com/news/22/25176/pm-modi-announces-grant-of-7-5-m-to-cervical-cancer-testing-screening-and-diagnostics-in-indo-pacific-region.html https://biospectrumindia.com/news/22/25176/pm-modi-announces-grant-of-7-5-m-to-cervical-cancer-testing-screening-and-diagnostics-in-indo-pacific-region.html Mon, 23 Sep 2024 00:00:00 +0530 Prime Minister (PM) Narendra Modi participated in the Quad Cancer Moonshot event hosted by President Joseph R Biden, on the sidelines of the Quad Leaders’ Summit in Wilmington, Delaware, US, on 21 September.Speaking on the occasion, Prime Minister deeply appreciated this thoughtful initiative of President Biden aimed at preventing, detecting and treating cervical cancer. He stated that the programme would go a long way in providing affordable, accessible and quality healthcare to people in Indo-Pacific countries. He noted that India was also undertaking a mass cervical cancer screening programme in the country. Talking of India’s health security efforts, he mentioned that the country has developed a cervical cancer vaccine and is working on an artificial intelligence (AI) based treatment protocol for the disease. As India’s contribution to the Cancer Moonshot initiative, Prime Minister announced the dedication of a grant of $7.5 million to cancer testing, screening, and diagnostics in the Indo-Pacific region. Prime Minister also announced that India will provide support for radiotherapy treatment and capacity building for cancer prevention in Indo-Pacific. He also mentioned that Indo-Pacific countries will be benefiting from the supply of 40 million doses of vaccine from India under GAVI and QUAD programmes.India will also offer technical assistance to interested countries in the Indo-Pacific region on digital public infrastructure (DPI) for cancer screening, care and continuum through its $10 million contribution to WHO’s-Global Initiative on Digital Health. ]]> https://biospectrumindia.com/news/22/25135/niti-aayog-launches-report-to-prepare-for-any-future-public-health-emergency.html https://biospectrumindia.com/news/22/25135/niti-aayog-launches-report-to-prepare-for-any-future-public-health-emergency.html Wed, 11 Sep 2024 00:00:00 +0530 NITI Aayog has released an Expert Group report titled ‘Future Pandemic Preparedness and Emergency Response- A Framework for Action’. The expert group in the report has provided a blueprint for the country to prepare for any future public health emergency or pandemic and have a rapid response system in place. Given the unpredictably, changing planetary ecology, climate and human-animal-plant dynamics, new potentially, large-scale infectious threats to human health are inevitable. The World Health Organisation (WHO) has warned the world that 75% of future public health threats are likely to be zoonotic threats (which could be due to emerging, re-emerging and new pathogens). In view of this, NITI Aayog constituted an Expert Group to prepare a Framework for Action for Future Pandemic Preparedness and Emergency Response. The Terms of Reference for the group were to examine how COVID-19 was managed at the national and global levels, pick up the key learnings both from the success stories and challenges faced, and assess the key gaps which need to be addressed to help us prepare and respond more efficiently and effectively in any future public health crisis. The recommendations of the Pandemic Preparedness and Emergency Response Framework (PPER) are in four pillars: Governance, Legislation, Finance and Management Data Management, Surveillance and Early Predictive Warning, Forecasting and Modelling, Research and Innovation, Manufacturing, Infrastructure, Capacity building/Skilling Partnership, Community engagement including risk communication, Private sector partnerships, and international collaborations Preparing the proposed framework for action for future pandemic preparedness and emergency response involved consultations with over 60 experts and stakeholders, analysing the experience so far, examining national and global success stories and identifying key gaps that need attention.  The expert group in the report has provided a blueprint for the country to prepare for any future public health emergency or pandemic and have a rapid response system.  ]]> https://biospectrumindia.com/news/22/25127/health-ministry-releases-annual-publication-of-infrastructure-and-human-resources-for-2022-23.html https://biospectrumindia.com/news/22/25127/health-ministry-releases-annual-publication-of-infrastructure-and-human-resources-for-2022-23.html Tue, 10 Sep 2024 00:00:00 +0530 Union Health Secretary, Apurva Chandra released "Health Dynamics of India (Infrastructure and Human Resources) 2022-23", an annual publication formerly known as “Rural Health Statistics”. The document has been published since 1992. Highlighting the document as a source of reliable and authentic information on various aspects of National Health Mission (NHM), Apurva Chandra stated that “The annual publication is a valuable document furnishing much needed information on manpower and infrastructure within NHM, helpful in policy making, improving processes and problem solving”. He added that the document gives a cross analysis across the states on the availability and deficiencies in manpower and infrastructure. The data is immensely helpful in understanding the requirements of the states, their priority areas and formulating policies and targeted campaigns. "The health statistics also aids in making a comparison in the performance of the states on different parameters", he highlighted. The key features of the publication include: Comparative Analysis: Provides comparisons of health infrastructure and manpower between 2005 and 2023, and from 2022 to 2023, highlighting progress and gaps District-Wise Data: Offers district-level details of health facilities, including Sub-Centers (SCs), Primary Health Centers (PHCs), Community Health Centers (CHCs), Sub-District Hospitals (SDHs), District Hospitals (DHs), and Medical Colleges Rural, Urban, and Tribal Focus: Details of infrastructure and manpower in rural, urban, and tribal areas, providing targeted insights for policy planning Classification of States/UTs: States and Union Territories are categorised based on key healthcare performance metrics, aiding in targeted interventions User-Friendly Highlights: Key findings are summarised at the beginning for quick reference Guidance for Stakeholders: Acts as a crucial tool for healthcare planning and management by identifying gaps and deficiencies in infrastructure and human resources. Union Health Secretary also pointed at the need to integrate the Health Management Information System (HMIS) Portal with Reproductive and Child Health (RCH) and other portals of the Ministry to reduce the burden of work of health functionaries and to ensure that the data are uploaded timely and analysed carefully. ]]> https://biospectrumindia.com/news/22/25119/health-ministry-approves-introduction-of-shorter-treatment-regimen-for-drug-resistant-tb-in-india.html https://biospectrumindia.com/news/22/25119/health-ministry-approves-introduction-of-shorter-treatment-regimen-for-drug-resistant-tb-in-india.html Fri, 06 Sep 2024 00:00:00 +0530 Union Ministry of Health & Family Welfare has approved introduction of the BPaLM regimen – a novel treatment for Multi-Drug-Resistant Tuberculosis (MDR-TB) under its National TB Elimination Programme (NTEP) as a highly effective and shorter treatment option.  This regimen includes a new anti-TB drug namely Pretomanid in combination with Bedaquiline & Linezolid (with/without Moxifloxacin). Pretomanid has earlier been approved & licensed for use in India by Central Drugs Standard Control Organization (CDSCO). The BPaLM regimen, which consists four-drug combination – Bedaquiline, Pretomanid, Linezolid and Moxifloxacin, has been proven to be safe, more effective and a quicker treatment option than the previous MDR-TB treatment procedure. While traditional MDR-TB treatments can last up to 20 months with severe side effects, BPaLM regimen can cure the drug-resistant TB in just six months with high treatment success rate.  India’s 75,000 drug-resistant TB patients will now be able to avail benefit of this shorter regimen. With the other advantages, there will be an overall saving in cost. Department of Health & Family Welfare, in consultation with Department of Health Research ensured validation of this new TB treatment regimen that witnessed a thorough review of evidences by in-country subject experts. Department of Health & Family Welfare has also got a Health Technology Assessment done through the Department of Health Research to ensure that this MDR-TB treatment option is safe and cost effective.   This move by Government of India is expected to significantly boost the country’s progress to achieve its national goal of Ending TB. A country-wide time-bound roll out plan of the BPaLM regimen is being prepared by the Central TB Division of Ministry of Health & Family Welfare in consultation with States/UTs, which includes rigorous capacity building of health professionals for safe administration of the new regimen. ]]> https://biospectrumindia.com/news/22/25098/karnataka-to-unveil-global-capability-centres-policy-at-bts-2024-in-november-kharge.html https://biospectrumindia.com/news/22/25098/karnataka-to-unveil-global-capability-centres-policy-at-bts-2024-in-november-kharge.html Tue, 03 Sep 2024 00:00:00 +0530 “Karnataka, home to over 400 Global Capability Centres (GCCs) is ready with draft a policy on GCCs and will be sharing with all stakeholders soon so that it will be unveiled at the Bengaluru Tech Summit 2024 (BTS 2024) set to take place from November 19 to November 21, 2024” said Priyank Kharge, Minister for IT, Bt, Government of Karnataka. Speaking at the Global Innovation Alliance (GIA) Partners meet at BTS 2024, Kharge said “Bengaluru is not just the tech capital of India; it’s a globally recognised hub for innovation, research, and technology-driven growth. The state’s dynamic ecosystem has attracted over $45 billion in foreign direct investment, with global giants establishing significant R&D centres here. With over 15,000 startups and a startup valuation of $180 billion, Karnataka is at the forefront of global innovation. It is also the leading destination for GCCs, with more than 400 centres already established in Bengaluru, making up over 40 per cent of all GCCs in India." Kharge further emphasised the importance of Bengaluru and Karnataka as a global hub for technology collaboration. He stated, “The Bengaluru Tech Summit has been instrumental in bringing together the brightest minds from around the world, and I strongly urge our Global Innovation Alliance (GIA) partners to include BTS 2024 in their event calendars. Active participation will not only contribute to our shared technology future but also help continue creating high-quality jobs, driving economic growth, and building a more connected, sustainable, and inclusive world. Karnataka remains the destination of choice for global technology collaboration, and we look forward to welcoming our GIA partners to explore new opportunities and drive innovation together.” Bengaluru Tech Summit 2024 under the theme ‘Breaking Boundaries’, will provide unbound opportunities that will feature a range of activities including a 6-track Conference covering IT & Deep Tech, Biotech & Healthtech, Startup Ecosystem, Global Innovation Alliance, India-USA Tech Conclave and newly added Electro-Semicon track. The Conference will host over 85 sessions featuring 460+ speakers.    ]]> https://biospectrumindia.com/news/22/25099/government-launches-national-strategy-for-prevention-of-unintentional-injury.html https://biospectrumindia.com/news/22/25099/government-launches-national-strategy-for-prevention-of-unintentional-injury.html Tue, 03 Sep 2024 00:00:00 +0530 The 15th World Conference on Injury Prevention and Safety Promotion (Safety 2024) commenced in New Delhi on 2nd September 2024, with a significant announcement, i.e. the launch of the National Strategy for Prevention of Unintentional Injury. The comprehensive roadmap, developed in collaboration between the Ministry of Health and Family Welfare, Government of India, the World Health Organization, and The George Institute for Global Health, aims to reduce the burden of injuries in India. The strategy prioritises four key injury mechanisms- road traffic injuries, drowning, burns, and falls from heights, and focuses on three vulnerable population groups- workers, children, and older people. It also emphasises state-level focus, recognising the importance of tailoring interventions to specific regional contexts. Speaking at the launch, Prof. (Dr.) Atul Goel, Directorate General of Health Services, Ministry of Health & Family Welfare, emphasised the importance of collaboration across various sectors and levels of government. "The strategy provides technical guidance and targeted action plans, empowering diverse stakeholders to take ownership of injury prevention efforts," he said. Safety 2024, held from September 2-4, brought together international experts to discuss strategies for reducing injury-related deaths and disabilities worldwide. Key themes included improving coordination among stakeholders, strengthening research capacity, integrating injury prevention with global health agendas, empowering communities, and promoting informed policymaking.     ]]> https://biospectrumindia.com/news/22/25055/cabinet-approves-vigyan-dhara-scheme-of-department-of-science-and-technology.html https://biospectrumindia.com/news/22/25055/cabinet-approves-vigyan-dhara-scheme-of-department-of-science-and-technology.html Sun, 25 Aug 2024 00:00:00 +0530 The Union Cabinet, chaired by Prime Minister Narendra Modi, has approved continuation of the three umbrella schemes, merged into a unified central sector scheme namely ‘Vigyan Dhara’ of Department of Science and Technology (DST). The scheme has three broad components: Science and Technology (S&T) Institutional and Human Capacity Building, Research and Development and Innovation, Technology Development and Deployment. The proposed outlay for the implementation of the unified scheme ‘Vigyan Dhara’ is Rs10,579.84 crore during the 15th finance Commission period from 2021-22 to 2025-26. The merger of the schemes into a single scheme would enhance efficiency in fund utilisation and establish synchronisation among the sub-schemes/programmes. The primary objective of the 'Vigyan Dhara' scheme is to promote S&T capacity building as well as research, innovation and technology development towards strengthening the Science, Technology and Innovation ecosystem in the country. Implementation of the scheme will strengthen the S&T infrastructure of the country by fostering well-equipped R&D labs in the Academic Institutions. The scheme endeavours to promote research in areas such as basic research with access to the international mega facilities, translational research in sustainable energy, water, etc. and collaborative research through international bilateral and multilateral cooperation. It will also contribute to building critical human resource pool to strengthen the science and technology landscape and expand the R&D base of the country towards improving the Full-Time Equivalent (FTE) researcher count. Focused interventions will be taken up to enhance the participation of women in the field of Science and Technology (S&T) with the ultimate goal of bringing gender parity in Science, Technology and Innovation (STI). The scheme would reinforce the efforts of the government towards promoting innovations at all levels, starting from school level to higher education, and for the industries and startups through targeted interventions. Significant support will be extended to increase collaboration between academia, Government, and also with industries.   ]]> https://biospectrumindia.com/news/22/25056/government-gives-nod-to-bioe3-policy-for-fostering-high-performance-biomanufacturing.html https://biospectrumindia.com/news/22/25056/government-gives-nod-to-bioe3-policy-for-fostering-high-performance-biomanufacturing.html Sun, 25 Aug 2024 00:00:00 +0530 The Union Cabinet, chaired by the Prime Minister Narendra Modi, has approved the proposal ‘BioE3 (Biotechnology for Economy, Environment and Employment) Policy for Fostering High Performance Biomanufacturing’ of the Department of Biotechnology. The salient features of BioE3 policy include innovation-driven support to R&D and entrepreneurship across thematic sectors. This will accelerate technology development and commercialization by establishing Biomanufacturing & Bio-AI hubs and Biofoundry. Along with prioritising regenerative bioeconomy models of green growth, this policy will facilitate expansion of India’s skilled workforce and provide a surge in job creation. Overall, this Policy will further strengthen Government’s initiatives such as ‘Net Zero’ carbon economy & ‘Lifestyle for Environment’ and will steer India on the path of accelerated ‘Green Growth’ by promoting ‘Circular Bioeconomy’. The BioE3 Policy will foster and advance future that is more sustainable, innovative, and responsive to global challenges and lays down the Bio-vision for Viksit Bharat. To address the national priorities, the BioE3 Policy would broadly focus on the following strategic/thematic sectors: high value bio-based chemicals, biopolymers & enzymes; smart proteins & functional foods; precision biotherapeutics; climate resilient agriculture; carbon capture & its utilisation; marine and space research.   ]]> https://biospectrumindia.com/news/22/25057/health-ministry-launches-national-medical-register-portal-of-national-medical-commission.html https://biospectrumindia.com/news/22/25057/health-ministry-launches-national-medical-register-portal-of-national-medical-commission.html Sun, 25 Aug 2024 00:00:00 +0530 Union Minister for Health & Family Welfare, Jagat Prakash Nadda inaugurated the National Medical Register (NMR) Portal of the National Medical Commission (NMC) for registration of all the MBBS doctors who are eligible for registration in India, in presence of Union Minister of State (MoS) for Health & Family Welfare, Anupriya Patel and virtual presence of Union MoS for Health & Family Welfare, Prataprao Jadhav. The National Medical Register (NMR) is mandated under Section 31 of the NMC Act, 2019 which states that the Ethics & Medical Registration Board (EMRB) of NMC shall maintain a National Register in electronic form containing the name, address, and all recognised qualifications possessed by a licensed medical practitioner. NMR will be a comprehensive and dynamic database for all allopathic (MBBS) registered doctors in India. The uniqueness of the NMR is that it is linked with the Aadhaar ID of the doctors which ensures the individual’s authenticity. Speaking at the event, Nadda stated that the National Medical Register will be upgraded and augmented with continuous improvements in the registration process on the portal. Highlighting the role of the State Medical Councils (SMCs), Nadda said, “the State Medical Councils are major stakeholders in the development and maintaining of National Medical Register and facilitating the registration process.” He urged the SMCs for their active participation and to fasten the registration process as their “efforts of authentication and speed of authentication will be a key factor in the success of NMR”. He further added that “we are also moving in the direction of launching a similar register for the paramedics and other healthcare professionals.” ]]> https://biospectrumindia.com/news/22/25039/health-ministry-hosts-international-delegation-of-policymakers-and-drug-regulators-from-15-countries.html https://biospectrumindia.com/news/22/25039/health-ministry-hosts-international-delegation-of-policymakers-and-drug-regulators-from-15-countries.html Mon, 19 Aug 2024 00:00:00 +0530 Union Minister of Health and Family Welfare & Chemicals and Fertilizers, J.P. Nadda inaugurated the ‘First Policy Makers’ Forum’, on 19th August, which will run until 22nd August 2024. To elevate India's position in the global pharmaceutical sector, the Indian Pharmacopoeia Commission (IPC), in collaboration with the Ministry of Health & Family Welfare and the Ministry of External Affairs, hosted an international delegation of policymakers and drug regulators from 15 countries.  The forum witnessed participation from various countries including Burkina Faso, Equatorial Guinea, Ghana, Guyana, Jamaica, Lao PDR, Lebanon, Malawi, Mozambique, Nauru, Nicaragua, Sri Lanka, Syria, Uganda and Zambia. The forum aims to foster meaningful discussions on the recognition of the IP and the implementation of India’s flagship Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), popularly known as the Janaushadhi Scheme. A key highlight of the event was the launch of two significant digital platforms by the Minister of Health and Family Welfare—the IP Online Portal and the Adverse Drug Reaction Monitoring System (ADRMS) software. The IP Online Portal represents a major step towards digitalising the Indian Pharmacopoeia, making drug standards more accessible to stakeholders worldwide. The ADRMS software, developed as part of the Pharmacovigilance Programme of India, is India’s first indigenous medical product safety database tailored to the needs of the Indian population. It facilitates the collection and analysis of adverse events related to medicines and medical devices, thereby significantly strengthening the country’s pharmacovigilance infrastructure. This software not only streamlines the reporting process but also empowers consumers and healthcare professionals to directly report adverse events, ensuring a more comprehensive capture of safety information. These digital initiatives are expected to enhance the accessibility and efficiency of drug safety monitoring and standards compliance, further boosting India’s position as a leader in the global pharmaceutical landscape. ]]> https://biospectrumindia.com/news/22/25028/national-health-authority-and-maharashtra-university-of-health-sciences-sign-mou-to-drive-digital-health-education.html https://biospectrumindia.com/news/22/25028/national-health-authority-and-maharashtra-university-of-health-sciences-sign-mou-to-drive-digital-health-education.html Wed, 14 Aug 2024 00:00:00 +0530 In a significant step towards driving Digital Health education across India, a Memorandum of Understanding (MoU) has been signed between the National Health Authority (NHA) and Maharashtra University of Health Sciences (MUHS) in the presence of Union Health Minister, J P Nadda. As part of the collaboration, MUHS will offer its Digital Health Foundation Course (DHFC) to NHA and co-develop additional Digital Health programmes, as suggested by NHA to support the roll-out of Ayushman Bharat Digital Mission (ABDM). NHA would continue to steer the government policy on the digital health landscape in the country for the development of an interoperable digital health ecosystem. The MoU also proposes to develop more such courses in the future. The Digital Health Foundation Course is a pivotal step in readying healthcare professionals for digital transformation and ABDM adoption. DHFC, created by MUHS with the support of the Koita Foundation, provides a comprehensive understanding of Digital Health fundamentals to doctors and healthcare providers. The DHFC curriculum has been curated by leading doctors and subject matter experts. The DHFC will be customised for the stakeholders in the public health ecosystem. The DHFC will be made available to medical students, in-service doctors, and healthcare professionals through various platforms, including Mission Karmayogi’s iGOT platform, providing opportunities for Digital Health certification and continuing medical education credits. It will help them implement the ABDM in their respective areas effectively. ]]> https://biospectrumindia.com/news/22/25008/national-biopharma-mission-completes-5-years-launches-impact-book.html https://biospectrumindia.com/news/22/25008/national-biopharma-mission-completes-5-years-launches-impact-book.html Fri, 09 Aug 2024 00:00:00 +0530 “Bio-Economy and Space Economy are going to spearhead India’s future growth story” says Union Minister Dr Jitendra Singh at the launch of ‘Impact Report 2024’ on National Biopharma Mission at the National Biopharma Mission Conclave celebrating its 5 years journey at the Dr. Ambedkar International Centre, New Delhi. Union Minister of State (Independent Charge) for Science and Technology, Dr Jitendra Singh recalled the journey of National Biopharma Mission since its inception along with Biotechnology Industry Research Assistance Council (BIRAC) “National Biopharma Mission (NBM) is Celebrating 5 Years of Pioneering Success” and called it a milestone. The National Biopharma Mission (NBM)- Innovate in India (I3) is an Industry-Academia Collaborative Mission for Accelerating Discovery Research for development of Biopharmaceuticals. BIRAC has the mandate to enable and nurture an ecosystem for preparing India’s technological and product development capabilities in bio pharmaceuticals, vaccines, biosimilars, medical devices and diagnostics.  The project was sanctioned with a total cost $250 million which is 50% co-funded by the World Bank. Today nearly 150 organisations and 300 MSMEs are being benefited from the programme. NBM has established 21 shared infrastructure facilities for research services and biomanufacturing. These facilities were also leveraged for the COVID-19 vaccine trials during the pandemic and are an important step towards India @2047, saving both cost & time. National Biopharma Mission has supported more than 200 grantees in three main domains: Vaccines, Biotherapeutics & Medical Devices and Diagnostics while also strengthening the ecosystem. The Mission has introduced over 18 successful products to the market including vaccines, biotherapeutics, medical devices, and diagnostic kits. ]]> https://biospectrumindia.com/news/22/25006/india-applies-for-international-medical-device-regulators-forum-membership.html https://biospectrumindia.com/news/22/25006/india-applies-for-international-medical-device-regulators-forum-membership.html Thu, 08 Aug 2024 00:00:00 +0530 At the recently held 16th CII Global MedTech Summit 2024, organised by the Confederation of Indian Industry (CII) on August 6, 2024, in Delhi, Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India, Central Drugs Standard Control Organisation provided an update on the regulatory framework for medical devices in India. He mentioned that India has applied for the International Medical Device Regulators Forum (IMDRF) membership. IMDRF is a global network of medical device regulators that promotes regulatory convergence and public health and safety. Dr Jitendra Singh, Minister of State (I/C) of the Ministry of Science and Technology emphasised the need for a collaborative approach to achieve the vision of Viksit Bharat by 2047. He highlighted that working in silos is not an option; instead, fostering collaboration across industry, academia, and government is essential. Looking to the future, he anticipated that Artificial Intelligence (AI) would play a transformative role in the coming years. Dr Vinod K. Paul, Member, NITI Aayog stressed the importance of a comprehensive approach to advancing India's MedTech sector. He also addressed the potential of AI and IoT in enhancing primary healthcare, specifically through improved screening mechanisms for conditions like eye care in children. Dr Paul advocated for a code of conduct to uphold the highest standards in medical devices. He urged the industry to capitalise on the facilitating ecosystem and policies in place and prioritise innovation. Dr Arunish Chawla, Secretary, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers informed that the Ministry is working towards bring a separate marketing code for medical devices. Further, Himanshu Baid, Chairman, CII National Medical Technology Forum & Managing Director, Poly Medicure stated that MedTech has come out of shadows of drugs and pharma industry and now standing as an independent industry with regulatory and government support. He called for a uniform code for medical device marketing practices and the fast-tracking of the New Drugs, Medical Devices, and Cosmetics Bill.   ]]> https://biospectrumindia.com/news/22/24980/ministry-of-ayush-inks-donor-agreement-with-world-health-organisation.html https://biospectrumindia.com/news/22/24980/ministry-of-ayush-inks-donor-agreement-with-world-health-organisation.html Thu, 01 Aug 2024 00:00:00 +0530 The Ministry of Ayush, Government of India and the World Health Organisation signed a Donor Agreement during a signing ceremony organised at WHO Headquarters in Geneva on 31st July, 2024. This agreement, which outlines the financial terms for implementing the activities of the WHO Global Traditional Medicine Centre (GTMC) in Jamnagar, Gujarat was signed by Arindam Bagchi, Permanent Representative of India to the UN, Geneva and Dr Bruce Aylward, Assistant Director-General for Universal Health Coverage and Life Course on behalf of Ministry of Ayush and WHO respectively. Through this collaboration, the Government of the Republic of India will donate $85 million over a period of 10 years (2022-2032) to support the operations of the WHO Global Traditional Medicine Centre (GTMC) in Jamnagar, Gujarat. The Donor agreement recognises the establishment of the WHO Global Traditional Medicine Centre as a key knowledge hub for evidence-based Traditional Complementary and Integrative Medicine (TCIM) aiming to advance the health and well-being of people and the planet. The Ministry of Ayush has collaborated with WHO on various fronts, including the development of benchmark documents for training and practice in Ayurveda, Unani and Siddha systems, the creation of WHO terminology for these practices, the introduction of a second module in the Traditional Medicine Chapter of the International Classification of Diseases-11, the development of apps like M-Yoga and support for the International Pharmacopoeia of Herbal Medicine (IPHM). These collaborative efforts, including those involving the WHO GTMC, will help India in positioning traditional medicine on the global stage. ]]> https://biospectrumindia.com/features/22/24950/union-budget-drives-home-viksit-bharat-mantra.html https://biospectrumindia.com/features/22/24950/union-budget-drives-home-viksit-bharat-mantra.html Wed, 31 Jul 2024 00:00:00 +0530 Presenting the Union Budget for the seventh time in a row on July 23, the Union Minister for Finance and Corporate Affairs, Nirmala Sitharaman proposed to abolish ‘angel tax’ for all classes of investors  and announced several measures like operationalisation of the Anusandhan National Research Foundation (ANRF) for basic research and prototype development and setting up a mechanism for spurring private sector-driven research and innovation at commercial scale with a financing pool of Rs 1 lakh crore in line with the announcement in the interim budget.  The Budget has enhanced the allocation to the Department of Scientific and Industrial Research (DSIR) from Rs 5746.51 crore in 2023-24 to Rs 6323.41 crore 2024-25 marking an increase of 10.03 per cent, of which Rs 6265.80 crore has been earmarked for Council of Scientific & Industrial Research (CSIR). The Union Budget 2024-25 is focussed on driving the growth and development of entrepreneurship, employment and skilling, making India a manufacturing hub of the world and boosting primary and secondary healthcare in the country – factors by and large being hailed by leaders and experts as keystones on India’s path of ‘Viksit Bharat’ to become one of the world’s biggest economy. The Prime Minister asserted “Today's budget has brought new opportunities, new energy, new employment and self-employment opportunities. It has brought better growth and a bright future.”    Healthcare/medtech   The government has increased the budget allocation for the healthcare sector by 15 per cent compared to the previous year. This increase aims to improve healthcare infrastructure and services across the country. Three cancer drugs namely Trastuzumab Deruxtecan, Osimertinib and Durvalumab have been fully exempted from custom duty, to make cancer treatment more affordable in the country. The budget has also introduced schemes to enable changes in Basic Customs Duty (BCD) on X-ray tubes & flat panel detectors for use in medical X-ray machines under the Phased Manufacturing Programme. Although the announcements have been welcomed by the healthcare sector, experts opine that customs duty reduction on finished goods is still a pending demand. Kiran Mazumdar Shaw, Chairperson, Biocon & Biocon Biologics said, “The removal of customs duty on three cancer drugs will provide relief to cancer patients. However, the government needs to consider GST exemption for all cancer drugs to make cancer care more affordable for patients.” “The exemption of customs duty on cancer medicines is a significant step towards making healthcare more accessible and affordable. As an oncologist, I feel that the government needs to look toward high-end treatments like Radiation Therapy, and Bone Marrow Transplant and make these within the reach of the common man”, said Dr Raj Nagarkar, MD & Chief of Surgical Oncology & Robotic Services, HCG Manavata Cancer Centre.  “The substantial allocation of Rs 90,958.63 crore to the health sector and increased funding for Ayushman Bharat PM-JAY have brought significant optimism within the healthcare industry. In continuation to this, to transform India's healthcare landscape, a holistic approach encompassing technology, infrastructure, and human capital is essential. Alongside prioritising affordability and accessibility, sustaining the momentum with continued investments and initiatives will help in positioning India as a premier destination for healthcare, benefiting patients both domestically and internationally. At Draeger, we look forward to contributing to India's journey towards a world-class healthcare system”, said Shalin Patel, Managing Director, Draeger India Group. Himanshu Baid, Managing Director, Poly Medicure Ltd and Chairman - CII Medical Technology Division said, “The Finance Minister's proposed changes in customs duty aimed at synchronising domestic capacity addition for X-ray tubes and flat panel detectors is worthy. This measure will bolster local manufacturing capabilities in medical technology, fostering self-reliance and enhancing accessibility to critical diagnostic equipment.” Referring to one of the core focusses of National Medical Devices Policy-2023 to reduce medical device import dependence, AiMeD Forum Coordinator, Rajiv Nath said that the Central government must also consider income tax benefits, specifically tailored for capital expenditure (CAPEX) and research and development (R&D) investments within the medical devices sector.  Pavan Choudhary, Chairman, Medical Technology Association of India (MTaI) commended the budget’s outlook on harnessing both the domestic and international currents to optimally forge the path ahead, and its facilitation of FDI. He also said, “We do hope that tariff barriers on finished MedTech products which are not import substitutable in the short to mid-term, will eventually come down. This would further patient affordability and foster competition and quality.”   Dashed Pharma Expectations  The Union Budget has increased allocation for R&D, particularly through the ANRF– an announcement that is largely being commended by the industry as a welcome step for clinical research and pharma sector’s growth. Experts have emphasised on the implications of simplifying regulatory processes and reducing operational hurdles in creating a more conducive environment for pharmaceutical companies to operate, innovate, and expand.  Sanjay Vyas, Executive Vice President and Managing Director, Parexel said, “Government's push for digital infrastructure under the Jan Vishwas Bill will significantly enhance the operational efficiency of clinical trials. Moreover, the budget's emphasis on skill development and women's empowerment will contribute to a robust talent pipeline for the life sciences sector. These measures collectively position India as a more attractive destination for Global Capability Centers (GCCs).” Although new incentives and schemes introduced in the Union Budget are being lauded by the pharma sector for its pro-innovation stance, industry leaders have opined on lacunae that need to be addressed as well. Anil Matai, Director General, Organisation of Pharmaceutical Producers of India (OPPI) said, “While we appreciate the positive strides taken in the Union Budget 2024, we were also hoping that the government could announce incentives for pharma companies to develop medications for rare diseases affecting small populations. We were hoping for focused measures like the establishment of more CoEs for the management of rare diseases. We were also hoping for the stricter and unambiguous enforcement of IP regulations required for Pharma MNCs to introduce newer innovative therapies for Indian patients.” Industry leaders are also expressing the unmet need for focus on areas of API manufacturing and reducing import dependence. Ashutosh Gupta, Director of Medicamen Organics Limited and former Chairman Pharmexcil Export Promotion Council of India said, "There is not much for the pharmaceutical sector in Budget 2024. We were expecting some more announcements to promote the API sector. We also expected some announcements on R&D.”    Further Push for Startup Ecosystem  This Budget is heavily focussed on boosting the country’s R&D, and innovation ecosystems through implementation of schemes and initiatives like the ANRF, eliminating "Angel Tax", extension of the limit of mudra loans to Rs 20 lakh from the current Rs 10 lakh, and a reduction of corporate tax on foreign companies from 40 to 35 per cent to invite investments.  Dr Jitendra Singh, the Union Minister of State (Independent Charge) for Science and Technology said "Budget 2024-25 will boost StartUps and the StartUp ecosystem through bold and innovative proposals like ending "Angel Tax" and introducing paid Internship". Hailing the abolition of the angel tax, Dr Premnath, Director, Venture Center, a Pune-based deep tech incubator, said, “It appears that Angel Tax will not apply to other investors, including non-resident investors or those not meeting criteria listed in the previous exemption. This will definitely help give comfort to many more investors in investing in startups.”  Sharing his views on the implications of the budget’s announcements, Dr Vishal Gandhi, Founder & CEO, BIORx Venture & Indian Healthcare Angels, said, “A major milestone achieved! The unconditional removal of the angel tax will alleviate the financial burden on startups raising capital, bolstering investor confidence and fostering innovation in the biotech and pharma sector particularly. High risk investments must translate into high rewards for investors and founders. This will be great motivation to encourage R&D to drive better economic impact in the near future.” Additionally, the Union Budget has made announcements in the areas of generating employment, skilling, and youth empowerment, which will also hold potential in advancing India’s healthcare, pharma and life sciences sectors. The Budget is also focussed on boosting MSMEs. In this regard, a highlight of this Budget also includes e-commerce export hubs - E-Commerce Export Hubs to be set up under public-private-partnership (PPP) mode for MSMEs to sell their products in international markets.  All-in-all a forward-looking Budget, it holds the potential to advance India’s healthcare, pharma and life sciences sector through enhancements in R&D, innovation, competent entrepreneurship strategies and youth upskilling.    Shivani Thakar shivani.thakar@biospectrumindia.com   ]]> https://biospectrumindia.com/news/22/24970/karnataka-govt-announces-launch-of-state-bioeconomy-report-2024.html https://biospectrumindia.com/news/22/24970/karnataka-govt-announces-launch-of-state-bioeconomy-report-2024.html Wed, 31 Jul 2024 00:00:00 +0530 Karnataka Innovation and Technology Society (KITS), under the Department of Electronics, IT, BT and S&T, Government of Karnataka, in collaboration with the Association of Biotechnology Led Enterprises (ABLE), has announced the launch of the Karnataka BioEconomy Report 2024. The Karnataka BioEconomy experienced a significant growth of approximately 10.7% from 2022 to 2023. In specific terms, the economic value increased from $28 billion in 2022 to $31 billion in 2023. One of India’s leading biotech states, Karnataka garnered more than 30% of investments in the sector nationally in 2023. The state’s $31 billion contributes 21 per cent to the national BioEconomy of $151 billion in 2023. It is only second to Maharashtra.  Bengaluru Urban dominates the BioEconomy landscape with a staggering $15.9 billion, representing 51.17% of the total BioEconomy in Karnataka. This district’s substantial contributions span multiple sectors, including biopharma, diagnostics, medical devices, and BioIT & services. BioPharma sector showed consistent growth over the three years, reaching $12.6 billion in CY 2023, while BioIndustrial sector exhibited steady increase from $7.9 billion in CY 2021 to $12.1 billion in CY 2023. Further, in 2023 alone, Karnataka welcomed 202 new biotech startups, marking a staggering 113% increase from 2021. With a total of 1,054 startups, Karnataka’s innovation hub is buzzing with entrepreneurial energy and cutting-edge research. Looking ahead, Karnataka’s ambitions are lofty yet attainable. The state aims to triple its BioEconomy to $100 billion by 2030. Achieving this goal requires concerted efforts in scaling BioPharma contributions to $30 billion, expanding BioAgri to $15 billion, and quadrupling BioIndustrial contributions to $30 billion. Embracing data science, AI, and deep tech innovations will be crucial in maintaining its leadership position ]]> https://biospectrumindia.com/news/22/24967/industry-associations-propose-reforms-in-drug-pricing-framework-.html https://biospectrumindia.com/news/22/24967/industry-associations-propose-reforms-in-drug-pricing-framework-.html Tue, 30 Jul 2024 00:00:00 +0530 In a recent meeting in New Delhi, industry associations met with Dr Arunish Chawla, Secretary of the Department of Pharmaceuticals (DoP), to discuss significant reforms in the pricing framework for drugs and medical devices.  Industry representatives recommended that cases of alleged overcharging should be limited to a three-year cut-off period from the date of the violation. They emphasised that certified data and pack shots should only be submitted once by the company and solely for the period of the alleged violation. The National Pharmaceutical Pricing Authority (NPPA) should only consider the officially submitted data in IPDMS Forms II, III, and V regarding pricing, batch numbers, manufacturing dates, production, and sales as proof of compliance. Furthermore, the alleged overcharged amount should only include the actual excess amount realised by a company on the Price to Stockist (PTS), excluding trade margins. The industry associations also advocated for a market-based pricing policy, which they believe is crucial for the growth of the Indian Pharmaceutical Market (IPM). Despite offering some of the lowest medicine prices globally, the IPM is subjected to stringent price controls. The market, characterised by over 5,000 manufacturers and 60,000 brands, is highly competitive, with numerous players in each therapeutic segment. While only 74 molecules were under DPCO 1995, the span of price control has significantly expanded with the National List of Essential Medicines (NLEM) 2022, covering approximately 400 molecules and 1,000 formulations. The DPCO 2013 marked a shift from cost-based to market-based pricing, a change welcomed by the industry. This approach allows pricing to reflect market realities rather than theoretical calculations, easing the process of determining market prices and improving compliance. The industry believes that refining the current pricing framework will provide a solid foundation for sustained growth. Industry associations highlighted several key areas for improvement in the current DPCO 2013 framework, which they described as impractical, contradictory, and ambiguous. These issues have led to numerous legal cases and uncertainty. The associations believe that addressing these concerns will simplify the procedures, ensure ease of doing business, and decriminalise certain provisions. The associations also recommended implementing revised prices for scheduled formulations on batches manufactured immediately after a price notification, rather than retroactively.    Bhagwati Prasad, Mumbai  ]]> https://biospectrumindia.com/news/22/24935/indias-healthcare-budget-2024-2025-a-strategic-leap-towards-comprehensive-health-reform.html https://biospectrumindia.com/news/22/24935/indias-healthcare-budget-2024-2025-a-strategic-leap-towards-comprehensive-health-reform.html Tue, 23 Jul 2024 00:00:00 +0530 India's Healthcare Budget 2024-2025 The healthcare budget for the fiscal year 2024-2025 signifies India's robust approach towards strengthening its healthcare infrastructure, expanding medical education, and enhancing healthcare services. The budget allocation for the Department of Health and Family Welfare stands at Rs 109,551.36 crore, showcasing a strategic increase from the previous year’s Rs 104,683.00 crore. This article delves into the detailed allocations and strategic priorities that underpin this significant budget. Overview of Budget Allocation Category 2022-2023 Actual (Rs Crore) 2023-2024 Budget (Rs Crore) 2023-2024 Revised (Rs Crore) 2024-2025 Budget (Rs Crore) Revenue 95,934.88 99,382.66 88,923.99 105,939.07 Capital 3,050.82 5,300.34 2,709.36 3,612.29 Total 98,985.70 104,683.00 91,633.35 109,551.36 The budgetary increase is primarily aimed at enhancing various healthcare initiatives, improving infrastructure, and addressing the critical needs of the population through targeted programs. Key Allocations and Strategic Initiatives Central Sector Schemes and Projects Pradhan Mantri Swasthya Suraksha Yojana (PMSSY): Allocated Rs 2,200.00 crore, PMSSY aims to correct regional imbalances in healthcare services and augment medical education facilities by establishing new AIIMS and upgrading existing medical institutions. National AIDS and STD Control Programme: With a budget of Rs 2,892.00 crore, this program focuses on preventing and controlling HIV/AIDS and sexually transmitted diseases through comprehensive strategies and interventions. Pradhan Mantri Ayushman Bharat Health Infrastructure Mission (PM-ABHIM): Receiving Rs 556.57 crore, PM-ABHIM is dedicated to developing health system capacities to respond effectively to future pandemics and disasters. Establishment Expenditure Major institutions like Safdarjung Hospital and Vardhman Mahavir Medical College, Dr. Ram Manohar Lohia Hospital, and Lady Hardinge Medical College have been allocated substantial funds to support their operational costs and infrastructural development. For instance, Dr. Ram Manohar Lohia Hospital and Atal Bihari Vajpayee Institute of Medical Sciences receive ₹1,610.00 crores, reflecting an increased focus on enhancing healthcare delivery. Institution 2023-2024 Budget (Rs Crore) 2024-2025 Budget (Rs Crore) Safdarjung Hospital and Vardhman Mahavir Medical College 1,853.34 1,874.00 Dr. Ram Manohar Lohia Hospital and Atal Bihari Vajpayee 1,272.18 1,610.00 Lady Hardinge Medical College and Smt. S.K. Hospitals 768.15 750.00 National Health Mission (NHM) The NHM has been granted ₹36,000.00 crores to strengthen rural and urban health systems, address healthcare needs of vulnerable sections, and support state and district-level health plans. Program 2023-2024 Budget (Rs Crore) 2024-2025 Budget (Rs Crore) National Health Mission (NHM) 29,085.26 36,000.00 Infrastructure Maintenance 6,798.37 7,000.00 Human Resources for Health and Medical Education A critical area of focus, this segment is allocated Rs 1,274.79 crore to establish new medical colleges, upgrade nursing and paramedical institutions, and increase the number of undergraduate and postgraduate seats in existing medical colleges. Regulatory and Statutory Bodies Bodies like the Food Safety and Standards Authority of India (FSSAI), the Indian Pharmacopoeia Commission (IPC), and the National Medical Commission (NMC) have been allocated funds to ensure the maintenance of high standards in medical education, food safety, and drug regulation. Regulatory Body 2023-2024 Budget (Rs Crore) 2024-2025 Budget (Rs Crore) Food Safety and Standards Authority of India (FSSAI) 639.10 675.21 Indian Pharmacopoeia Commission (IPC) 8.53 8.53 National Medical Commission (NMC) 53.20 54.00 Focus on Innovation and Pandemic Preparedness The budget places a strong emphasis on innovation and preparedness, particularly in response to the lessons learned from the COVID-19 pandemic. Initiatives like the National Digital Health Mission (NDHM) and the National Tele Mental Health Programme highlight the government's commitment to leveraging technology to improve healthcare access and delivery. The NDHM aims to create a comprehensive digital health ecosystem, while the tele-mental health program seeks to provide equitable and affordable mental health services nationwide. Program 2023-2024 Budget (Rs Crore) 2024-2025 Budget (Rs Crore) National Digital Health Mission (NDHM) 341.02 200.00 National Tele Mental Health Programme 133.73 90.00 A Strategic Blueprint for Future-Ready Healthcare The 2024-2025 healthcare budget is a testament to the government's strategic approach to building a robust healthcare system capable of addressing both current and future challenges. By focusing on infrastructure development, strengthening healthcare services, enhancing medical education, and leveraging technology, the budget aims to ensure that quality healthcare is accessible to all sections of the population. These investments are expected to yield significant improvements in health outcomes and contribute to the overall well-being of the nation. In summary, the healthcare budget for 2024-2025 sets a clear direction for India's health policy, emphasizing innovation, preparedness, and inclusive growth. It reflects a commitment to not only overcoming present challenges but also to building a resilient and efficient healthcare system for the future. ]]> https://biospectrumindia.com/news/22/24930/economic-survey-lays-focus-on-mental-healthcare-for-the-first-time.html https://biospectrumindia.com/news/22/24930/economic-survey-lays-focus-on-mental-healthcare-for-the-first-time.html Mon, 22 Jul 2024 00:00:00 +0530 For the first time ever, the Economic Survey 2023-24 tabled by the Union Minister of Finance and Corporate Affairs Nirmala Sitharaman in Parliament on 22 July, talks extensively about mental health, its significance and implications on policy recommendations. Acknowledging mental health as a principally impactful driver of individual and national development, the Survey notes that as per the National Mental Health Survey (NMHS) 2015-16, 10.6% adults in India suffered from mental disorders while treatment gap for mental disorders ranged between 70% and 92% for different disorders. Further, the prevalence of mental morbidity was higher in urban metro regions (13.5%) as compared to rural areas (6.9%) and urban non-metro areas (4.3%). Citing NCERT’s Mental Health and Well-being of School Students Survey, the Economic Survey highlights an increasing prevalence of poor mental health among adolescents exacerbated by the COVID-19 pandemic, with 11% of students reported as feeling anxious, 14% as feeling extreme emotion and 43% experiencing mood swings. Recognising mental health as a fundamental aspect of overall well-being, the Survey underscores key initiatives and policies taken by the government in this regard such as National Mental Health Programme; National Tele Mental Health Programme; Increasing mental health personnel; and Rashtriya Kishor Swasthya Karyakram. The Survey stresses on proper implementation to accelerate the improvements made in mental healthcare on the ground and address gaps in the existing programmes to maximise their effectiveness. Important policy recommendations include re-doubling efforts to increase the number of psychiatrists, from 0.75 psychiatrists per lakh population in 2021 to the WHO norm of 3 per lakh population; Developing comprehensive guidelines for the excellence centers’ services alongside mental healthcare professionals and users to understand their needs; Assessing the effectiveness of the programmes by gathering feedback from the users, professionals, and stakeholders to make necessary changes and meet the needs of a wider population; Effective pathways for integrating mental health interventions in schools including developing an age-appropriate mental health curriculum for teachers and students, encouraging early intervention and positive language in schools, promoting community-level interactions, and balancing the role of technology. ]]> https://biospectrumindia.com/reports-white-papers/22/24915/oops-they-did-it-again-indian-pharmas-frequent-flyers-on-fdas-naughty-list.html https://biospectrumindia.com/reports-white-papers/22/24915/oops-they-did-it-again-indian-pharmas-frequent-flyers-on-fdas-naughty-list.html Thu, 18 Jul 2024 00:00:00 +0530 One of the FDA's key regulatory actions includes issuing warning letters to pharmaceutical companies that fail to comply with current good manufacturing practice (CGMP) regulations. These letters alert companies to significant violations and demand corrective actions to prevent potential health risks to consumers. Indian pharmaceutical companies, which play a major role in the global drug supply chain, have been recipients of such FDA warning letters. The Indian pharmaceutical sector has witnessed many warnings issued by the FDA in 2023-2024. These letters typically address issues related to quality control, data integrity, manufacturing processes, and compliance with CGMP standards. Indian firms, including prominent manufacturers, often face scrutiny due to the scale of their operations and their critical role in supplying affordable generic medications worldwide. The FDA's oversight ensures that these companies maintain high standards to protect patient health and safety, and non-compliance can result in significant consequences, including product recalls, import bans, and delays in drug approvals.   Recent FDA Warning Letters Natco Pharma Date: April 8, 2024 The FDA conducted an inspection of Natco Pharma Limited's drug manufacturing facility in Kothur Village Rangareddy, Telangana, India, from October 9 to 18, 2023. The inspection revealed significant violations of CGMP regulations for finished pharmaceuticals. These violations included inadequate cleaning, maintenance, and sanitation of equipment, leading to contamination risks. The response from Natco Pharma was deemed insufficient, and the FDA required a comprehensive assessment and corrective action plan. Natco Pharma has committed to temporarily suspend production of all drugs intended for the U.S. market while addressing the CGMP violations. Insight: Natco Pharma's situation underscores the critical importance of robust cleaning protocols and comprehensive responses to regulatory findings. Temporary suspension of production can significantly impact revenue and market presence, emphasizing the need for proactive quality assurance measures. Sun Pharmaceuticals Date: June 18, 2024 An inspection of Sun Pharmaceutical Industries Limited, located in Dadra and Nagar Haveli, revealed significant CGMP violations. These included inadequate cleaning and maintenance of equipment, leading to contamination risks. The FDA noted repeated violations at multiple sites within Sun Pharmaceutical's network, indicating inadequate management oversight. The company was given 15 working days to respond with corrective actions and plans to prevent recurrence. Insight: Sun Pharmaceuticals' recurring issues across multiple sites highlight systemic challenges within the company's quality management system. Addressing these requires not only localized fixes but also a top-down reevaluation of corporate governance and quality culture. Dr. Sankunni’s Ayurvedic Research Foundation Private Ltd. Date: April 18, 2024 The FDA issued a warning letter to Dr. Sankunni’s Ayurvedic Research Foundation regarding serious violations related to the drug listing information submitted for multiple products. These discrepancies rendered the products misbranded, and the FDA emphasized the importance of accurate listing for patient safety. Immediate corrective actions were required, with a detailed response expected within 15 working days. Insight: The case of Dr. Sankunni’s Ayurvedic Research Foundation highlights the critical role of accurate documentation and transparent communication with regulatory bodies. Misbranding not only jeopardizes patient safety but also erodes trust and market credibility. Kilitch Healthcare India Limited Date: March 28, 2024 Kilitch Healthcare's facility in Navi Mumbai was found to be operating under insanitary conditions, leading to adulteration of drug products. Violations included inadequate facility maintenance, poor aseptic practices, and deficiencies in the quality control unit's oversight and data integrity. The FDA demanded comprehensive remedial actions and a detailed plan for data integrity remediation. Insight: Kilitch Healthcare’s violations emphasize the need for stringent aseptic practices and robust data integrity protocols. Ensuring a clean and controlled manufacturing environment is fundamental to maintaining product quality and patient safety. Madhu Instruments Private Limited Date: February 1, 2024 An FDA inspection of Madhu Instruments Private Limited revealed significant deficiencies in the manufacturing environment and equipment maintenance. The response to the FDA's Form 483 was deemed inadequate, and the FDA emphasized the necessity for robust corrective measures. The facility was placed on Import Alert 66-40, meaning products may be detained or refused admission into the United States unless compliance is confirmed. Insight: Madhu Instruments’ situation illustrates the severe consequences of failing to maintain sanitary conditions and appropriate maintenance protocols. Import alerts can severely disrupt business operations and market access, necessitating immediate and effective corrective actions. Patcos Cosmetics Pvt. Ltd. Date: December 15, 2023 Patcos Cosmetics Pvt. Ltd. faced significant CGMP violations, including failure to conduct proper identity tests for high-risk components susceptible to contamination. The FDA placed the firm on Import Alert 66-40 and required prompt corrective actions and a detailed response within 30 working days. Insight: Patcos Cosmetics' failure to conduct identity tests for high-risk components underscores the critical need for thorough quality control testing. Ensuring the safety of ingredients is paramount to prevent harmful contamination and maintain consumer trust. Intas Pharmaceuticals Limited Date: November 21, 2024 An inspection of Intas Pharmaceuticals Limited's facility in Ahmedabad revealed significant CGMP violations, including data integrity issues and failures in investigating discrepancies. The FDA demanded detailed remediation plans and effective executive management oversight. Insight: Intas Pharmaceuticals’ data integrity issues highlight the essential role of accurate and reliable record-keeping in pharmaceutical manufacturing. Addressing these issues requires a comprehensive overhaul of data management systems and enhanced oversight from executive leadership. Cipla Limited Date: November 17, 2024 Cipla Limited’s facility in Indore faced significant CGMP violations, including inadequate investigations into quality defect complaints and media fill contamination incidents. The FDA requested comprehensive corrective actions and independent assessments of their investigation system and CAPA program. Insight: Cipla Limited's case underscores the importance of thorough investigation and resolution of quality complaints. Effective CAPA programs are vital to prevent recurring issues and ensure continuous improvement in manufacturing practices. Global Pharma HealthCare Private Limited Date: October 20, 2023 Global Pharma Healthcare faced significant CGMP violations, including failure to conduct Antimicrobial Effectiveness Testing and inadequate cleanroom practices. The FDA requested a comprehensive risk assessment and remediation plan addressing all contamination hazards. Insight: The failure to conduct critical testing, such as Antimicrobial Effectiveness Testing, at Global Pharma Healthcare highlights the risks associated with inadequate product safety evaluations. Implementing rigorous testing protocols is essential to safeguard public health. Sun Pharmaceutical Industries Ltd. (Halol Facility) Date: October 16, 2023 An inspection of Sun Pharmaceutical’s Halol facility revealed significant CGMP violations, including inadequate aseptic practices and cleanroom design. The FDA required a comprehensive action plan and the engagement of a CGMP consultant. Insight: Sun Pharmaceutical’s Halol facility underscores the complexity of maintaining aseptic conditions in drug manufacturing. Comprehensive action plans and external consulting can provide valuable expertise to address systemic issues. Jubilant Generics Limited Date: March 6, 2019 The FDA inspection of Jubilant Generics Limited’s facility revealed significant CGMP violations, including inadequate investigation of batch failures and insufficient quality control. The FDA recommended hiring a qualified CGMP consultant to ensure compliance. Insight: Jubilant Generics' recurring CGMP violations highlight the need for sustained improvements in quality management systems. Engaging external consultants can provide the necessary expertise to achieve compliance and enhance operational standards. Medgel Private Limited Date: July 20, 2023 Medgel Private Limited faced significant CGMP violations, including inadequate investigation of batch failures and poor data integrity practices. The FDA requested a detailed plan to address these deficiencies and improve CGMP systems. Insight: Medgel's violations demonstrate the critical importance of thorough batch failure investigations and maintaining data integrity. Addressing these issues is fundamental to ensuring product quality and regulatory compliance. Centaur Pharmaceuticals Private Ltd. (Pune Facility) Date: July 25, 2023 An inspection of Centaur Pharmaceuticals’ Pune facility revealed significant CGMP violations, including inadequate cleaning procedures and insufficient quality control. The FDA required a comprehensive remediation plan and independent evaluation of cleaning effectiveness. Insight: Centaur Pharmaceuticals’ Pune facility highlights the necessity of maintaining rigorous cleaning procedures and quality control measures. Independent evaluations can provide objective assessments to identify and rectify deficiencies. Centaur Pharmaceuticals Private Ltd. (Ambernath Facility) Date: June 5, 2024 Centaur Pharmaceuticals’ Ambernath facility faced significant deviations from CGMP for active pharmaceutical ingredients, including inadequate document control and cleaning practices. The FDA requested a detailed corrective action and preventive action plan. Insight: Centaur Pharmaceuticals’ Ambernath facility underscores the critical role of document control and cleaning practices in ensuring compliance with CGMP. Detailed CAPA plans are essential to address root causes and prevent recurrence of violations.   Cleaning Up Their Act: Indian Pharma’s Brush with FDA Reality Check – Will They Finally Learn?   The recent series of FDA warning letters issued to Indian pharmaceutical companies highlights ongoing compliance challenges in the industry. Prominent firms, including Natco Pharma, Sun Pharmaceuticals, and Cipla Limited, have faced significant violations of CGMP regulations. These violations encompass inadequate cleaning procedures, insufficient quality control, data integrity issues, and non-compliance with aseptic processing standards. The FDA's rigorous inspections and subsequent warnings underscore the necessity for these companies to enhance their manufacturing practices and ensure adherence to regulatory standards. The emphasis on corrective and preventive actions (CAPA) and the engagement of qualified consultants illustrates the FDA's commitment to safeguarding public health. Failure to address these deficiencies could lead to severe consequences, such as import bans, delayed drug approvals, and potential legal actions. This situation calls for robust improvements in quality systems, executive management oversight, and sustained efforts to maintain compliance. Moreover, these incidents highlight the need for a proactive approach to regulatory compliance. Pharmaceutical companies must invest in advanced quality management systems, continuous training programs for staff, and regular internal audits to preemptively identify and address potential issues. Establishing a culture of quality and compliance is essential to mitigating risks and ensuring the consistent delivery of safe and effective pharmaceutical products. In the move, the persistent regulatory scrutiny by the FDA serves as a critical reminder of the stringent standards required in pharmaceutical manufacturing. Indian pharmaceutical companies must rise to the challenge by implementing comprehensive corrective actions, enhancing transparency, and fostering a culture of continuous improvement. By doing so, they can not only meet regulatory expectations but also strengthen their position in the global pharmaceutical market, ultimately contributing to better health outcomes worldwide.   ]]> https://biospectrumindia.com/news/22/24918/indian-rubber-cloves-manufacturers-association-urges-ban-on-non-compliant-imported-gloves-to-boost-hospital-safety.html https://biospectrumindia.com/news/22/24918/indian-rubber-cloves-manufacturers-association-urges-ban-on-non-compliant-imported-gloves-to-boost-hospital-safety.html Thu, 18 Jul 2024 00:00:00 +0530 The Indian Rubber Gloves Manufacturers Association (IRGMA) in its latest bid to mitigate safety and health risks of medicos has sought directives through communications to the Ministry of Environment, Forests and Climate Change to ban the import of chlorinated gloves and has also notified the Customs (Imports) Department of the violation of bio-waste disposal rules by importers especially of the phased out chlorinated gloves, and non-compliance of gloves manufacturers sending chlorinated gloves to India, some making way into India spuriously. IRGMA is seeking the use of only BIS Approved Gloves, through GEM, for Government Hospitals, conforming to the consideration and implementation of QCO (Quality Control Order) aligned with MDR 2017 Compliance of CDSCO Gazette Notification which was to come into effect from 1st Oct 2022. In their communications to the aforesaid authorities, IRGMA has brought to notice that the Central Pollution Control Board had issued a letter to phase out the use of chlorinated gloves by 27th March 2019; that West Bengal State Pollution Control Board has issued directives to ban the use of chlorinated gloves and that CPCB has issued directive not to allow imports in violation of guidelines that ban chlorinated gloves. In yet another communication to the Malaysian Rubber Council, IRGMA has specified that chlorinated gloves of all kinds are not allowed by the Indian authorities owing to violation of the guidelines, and that they do not require test to be validated in the view of Ministry of Health and Family Welfare of India, and Biomedical Waste Rules 2016. In their communication to AIIMS, IRGMA has issued a disclaimer to ensure that the healthcare industry procures the right quality of Disposal, Latex and Nitrile gloves to comply with the expected standards and rules prevalent. The continuation of spurious import of examination gloves has serious safety and health risks. Many countries (US and Europe) have already banned the use of powdered, coated Nitrile Gloves, in their respective countries. The procurement of BIS Approved Gloves is very convenient because there are already many BIS certified companies manufacturing the gloves, and these companies are capable of supplying the quality product to the Hospital Staff. Speaking about the directives on chlorinated gloves, Mr. Sunil Patwari (President – IRGMA) said, “It is time that these spurious imports and usage of chlorinated gloves be curbed as it is detrimental to the health of both the healthcare providers and the patients, and for their safety the Government and the authorities must make firm implementations that impede the spurious circulation and import of chlorinated gloves.” Mr. Konda Anindith Reddy (Managing Director – Wadi Surgicals Enliva Gloves) added, “We need to ensure that we are providing the right quality gloves to the medical practitioners for the safety of them and the patients as well. This kind of trust will come only if there is a stringent regulation on the spurious circulation and import of chlorinated gloves.” Medicos working in acute medical care units are at maximum risk of contracting infection with defective gloves. Even patients are equally at risk of contracting cross-infections if exposed to any open areas from a torn surgical glove worn by medical staff. ]]> https://biospectrumindia.com/news/22/24856/ministry-of-ayush-strengthens-testing-and-standardisation-protocols-to-ensure-safety-of-ayurvedic-medicines.html https://biospectrumindia.com/news/22/24856/ministry-of-ayush-strengthens-testing-and-standardisation-protocols-to-ensure-safety-of-ayurvedic-medicines.html Wed, 03 Jul 2024 00:00:00 +0530 In a significant development aimed at advancing the field of Indian Medicine and Homoeopathy, a Memorandum of Understanding (MoU) was signed between the Central Council for Research in Ayurvedic Sciences – Captain Srinivasa Murthy Central Ayurveda Research Institute (CSMCARI), Chennai, under the Ministry of AYUSH, Government of India and the Commissionerate of Indian Medicine and Homoeopathy (CIM&H), Arumbakkam, Chennai, Tamil Nadu.  The ceremony was held recently at the Kalaignar Centenary Multi-Speciality Hospital, Guindy, in the presence of Health and Family Welfare Minister of Tamil Nadu, MA. Subramanian, and Additional Chief Secretary & Health and Family Welfare Secretary, Gagan Deep Singh, IAS. The MoU outlines a collaborative framework for Testing Services, Imparting Training, and executing a Collaborative Project on “Research Studies for the Standardization and Evaluation of Toxicity Studies for the Preparation of Selected Higher Order Medicines.” The primary objectives of this MoU include: To carry out testing of selected raw drugs asnd finished products for the purpose of standardization of medicine. Providing NABL Accreditation Training guidance to the Laboratory of CIM&H. Conducting the collaborative research project entitled “Research Studies for Standardization and Evaluation of the toxicity study for the preparation of selected higher order medicines” as per the approved proposal, being a part and parcel of this MoU, as per the terms, conditions, and guidelines of CCRAS Research Policy. The rigorous testing and standardization protocols will ensure the higher quality and safety of Ayurvedic and Homoeopathic medicines, benefiting practitioners and patients alike. NABL Accreditation Training guidance will enhance the capabilities of the CIM&H laboratory, ensuring adherence to the highest standards. Joint research projects will focus on evaluating the toxicity of selected higher-order medicines, contributing valuable data to the scientific community and ensuring the safety and efficacy of these treatments. The partnership will promote ongoing knowledge exchange and capacity building, fostering a collaborative environment that encourages innovation and excellence in Indian Medicine and Homoeopathy. ]]> https://biospectrumindia.com/news/22/24812/health-ministry-unveils-national-stop-diarrhoea-campaign-2024.html https://biospectrumindia.com/news/22/24812/health-ministry-unveils-national-stop-diarrhoea-campaign-2024.html Mon, 24 Jun 2024 00:00:00 +0530 Union Minister of Health and Family Welfare, Jagat Prakash Nadda launched the National STOP Diarrhoea Campaign 2024, in New Delhi. He was joined by Anupriya Patel and Jadhav Patraprao Ganpatrao, Union Ministers of State for Health and Family Welfare. The dignitaries also released IEC materials like logo, posters, radio spots and audio visuals for the campaign and distributed oral rehydration salts (ORS) and zinc tablets to children on the occasion. The goal behind the STOP Diarrhoea Campaign 2024 is to attain zero child deaths due to childhood diarrhoea. While the existing diarrhoea strategy entailed a 2-week campaign with pre-positioning of ORS to under-5 children and limited IEC, the new strategy involves a 2-month long campaign with pre-positioning of 2 ORS packets and zinc as a co-packaging to under-5 children. It will also involve extensive IEC through different platforms and collaboration across multiple sectors, including health, water and sanitation, education, and rural development. Union Health Minister also emphasised on the importance of sensitising health workers along with enhancing capacity building efforts to strengthen diarrhoea management effort in India.  To tackle the persistent issue of childhood diarrhoea and strive for zero child deaths, the Ministry of Health and Family Welfare (MoHFW) has rebranded its long-standing Intensified Diarrhoea Control Fortnight (IDCF) as the STOP Diarrhoea Campaign. This initiative, which began in 2014, focuses on enhancing the Prevent, Protect, and Treat (PPT) strategy and increasing the use of Oral Rehydration Solution (ORS) and Zinc.  ]]> https://biospectrumindia.com/news/22/24783/rare-disease-patients-appeal-to-new-health-minister-for-urgent-policy-intervention.html https://biospectrumindia.com/news/22/24783/rare-disease-patients-appeal-to-new-health-minister-for-urgent-policy-intervention.html Mon, 17 Jun 2024 00:00:00 +0530 With the third consecutive term win of the government, rare disease patients and their caregivers wrote to the newly appointed Union Minister at JP Nadda to draw Ministry’s attention to the critical gaps that remain in the implementation of the National Policy for Rare Diseases (NPRD) 2021. The lives of many patients (mostly children) suffering from chronic rare genetic disorders, such as Lysosomal Storage Disorders (LSDs), are still fraught with uncertainty due to the lack of sustainable funding and delays in the effective utilisation of the allocated funds. The Centres of Excellence (CoEs), pivotal in this initiative, need to expedite the process to ensure timely access to life-saving treatments.There is an immediate need to prioritise, ensure uninterrupted funding support for all notified ultra-rare diseases, conditions which are chronic in nature, but have approved therapies with excellent clinical outcomes. The current budgetary provision up to Rs 50 lakh is only one-time, thereby hindering the process of saving lives for patients diagnosed with these conditions. Several patients across the Centres of Excellence (CoEs) have once again been put off life-saving therapies after the one-time support exhausted.Although notified as a Group 3(a) condition in the NPRD 2021, patients diagnosed with Pompe disease, Fabry disease, MPS I and II are still not getting the same priority at the CoEs, thereby delaying treatment and posing serious risk to their lives.  Many of the CoEs have still not been able to effectively utilise the funds provided by the Ministry, thereby limiting access to life-saving therapy. Repeated appeals to the CoEs and the Ministry in this regard have not yielded any impact so far. ]]> https://biospectrumindia.com/news/22/24731/orchid-pharma-receives-dcgi-approval-for-cefepime-and-enmetazobactam-antibiotic.html https://biospectrumindia.com/news/22/24731/orchid-pharma-receives-dcgi-approval-for-cefepime-and-enmetazobactam-antibiotic.html Thu, 06 Jun 2024 00:00:00 +0530 Orchid Pharma, based in Chennai, has received Drugs Controller General of India (DCGI) approval for the manufacturing and marketing of its invented New Chemical Entity Active Pharmaceutical Ingredient (API), Enmetazobactam. DCGI has also granted permission to manufacture and market Finished Dosage Form (FDF) of Cefepime and Enmetazobactam as a dry powder injectable. This formulation is indicated for the treatment of complicated Urinary Tract Infections (cUTI) including acute Pyelonephritis, Hospital-Acquired Pneumonia (HAP) including Ventilator-associated pneumonia (VAP), and Bacteremia when it is associated or suspected to be associated with either complicated urinary tract infections or hospital-acquired pneumonia.   With this approval, Orchid Pharma intends to improve the treatment landscape for serious infections in India, providing patients with access to advanced and effective therapy options. This new Combination Drug provides a powerful treatment option against a range of severe infections caused by resistant bacteria, addressing a critical need in combating antimicrobial resistance. Speaking on the approval, Manish Dhanuka, Managing Director, Orchid Pharma, said, “Enmetazobactam’s approval in India is personally fulfilling as being an Indian company, we wanted to expand access to advanced and affordable treatment options for patients in India." The company looks forward to the successful launch and distribution of Enmetazobactam and its combination with Cefepime for enhancing the treatment landscape for severe infections in India. ]]> https://biospectrumindia.com/news/22/24686/ayush-ministry-takes-initiative-to-propel-ayurveda-research-in-collaboration-with-pharma.html https://biospectrumindia.com/news/22/24686/ayush-ministry-takes-initiative-to-propel-ayurveda-research-in-collaboration-with-pharma.html Tue, 28 May 2024 00:00:00 +0530 The Central Council for Research in Ayurvedic Sciences (CCRAS), an autonomous body under the Union Ministry of Ayush, has launced 'PRAGATI- 2024' (Pharma Research in AyurGyan And Techno Innovation). It offers a very useful opportunity for collaborative reasearch in the filed of Ayurveda. Today’s interactive meeting aimed to explore research opportunities and foster collaboration between CCRAS and the Ayurveda drug industry. On this occasion, Secretary, Ministry of Ayush, Vaidya Rajesh Kotecha, emphasised the industry's crucial role in the development of Ayurveda. He highlighted the vast potential industries have to expand and advance the sector, noting that the influx of new practitioners and startups presents tremendous growth opportunities. The primary goal is to utilise research outcomes and technologies developed by CCRAS; establish robust networks for collaborative research in quality control, drug standardisation, product development, and validation; identify potential industrial partners with in-house R&D facilities; explore opportunities for capacity building for researchers in drug manufacturing and product development; and assist Ayurveda professionals in initiating startups and incubating centres, promoting entrepreneurship in Ayurvedic pharmaceutics. ]]> https://biospectrumindia.com/news/22/24658/philippines-announces-education-policy-to-open-doors-for-indian-medical-aspirants.html https://biospectrumindia.com/news/22/24658/philippines-announces-education-policy-to-open-doors-for-indian-medical-aspirants.html Thu, 23 May 2024 00:00:00 +0530 In a landmark move, the Philippines has announced a policy change that will significantly benefit Indian medical students pursuing their MBBS degrees. A recent amendment to the Philippine Medical Act of 1959 has been approved by the House of Representatives, paving the way for Indian students, including those from foreign, to register and practice medicine in the Philippines.  This development comes after several years of persistent requests from India, recognising the Philippines as a top global destination for medical education. The Philippines has emerged as a rising star in medical education, attracting aspiring doctors worldwide. It offers high-quality education at competitive costs, with tuition fees significantly lower than those in Western countries. The US-aligned curriculum ensures smooth transitions to international careers, supported by a strong network of globally recognised residency programmes. Under this new provision, Indian students who complete their Doctor of Medicine degree from a Philippine College of Medicine recognised by the Commission on Higher Education (CHED), along with a 12-month internship, will be eligible to register and practice medicine in the Philippines. The CHED will issue the necessary certification to facilitate this process, ensuring a smooth transition for Indian graduates. With 64 duly authorized medical schools across the Philippines, Indian students now have an even more compelling reason to pursue their medical education in this country.  ]]> https://biospectrumindia.com/news/22/24643/government-focuses-on-digitalisation-of-animal-vaccine-cold-chain-management.html https://biospectrumindia.com/news/22/24643/government-focuses-on-digitalisation-of-animal-vaccine-cold-chain-management.html Mon, 20 May 2024 00:00:00 +0530 The Department of Animal Husbandry & Dairying (DAHD), Ministry of Fisheries, Animal Husbandry & Dairying has signed a Memorandum of Understanding (MoU) with the United Nations Development Programme (UNDP) India on Digitalisation of Vaccine Cold Chain Management, Capacity Building, and Communication Planning. “With digitalisation of the entire vaccine stock management system and providing real-time information on vaccine stocks and flows, and storage temperatures, the inequities in vaccine supply will be addressed by managing constraints of infrastructure, management information systems, and human resources", said Alka Upadhyay, Secretary, Department of Animal Husbandry & Dairying. The vaccine cold chain management process, she added will be monitored with the help of new age technology and artificial intelligence through the Animal vaccine Intelligence Network (AVIN) developed by UNDP. UNDP Resident Representative Caitlin Wiesen, while signing the MoU, said that amid confluence of frequent zoonotic disease outbreak and climate change, animals and the communities engaged in rearing them are increasingly vulnerable. She added that through this partnership with the Department of Animal Husbandry and Dairying, UNDP will support and strengthen India’s first animal vaccine supply chain management system ensuring communities and animals are protected and further mitigating the risks at the human-animal-environment interface. UNDP and DAHD will jointly work on Strengthening Animal Health with One Health approach at centre. This step will contribute to creation of a digital future via digitalization and remote temperature monitoring of cold chain by UNDP India. This will ensure that vaccines are stored in an adequate temperature of prescribed limit of 2-8 degree Celsius which is important to increase immunization coverage and outreach. Currently, DAHD is supplying FMD (Foot and Mouth diseases) vaccine worth approximately Rs 900 crore this year and aims to cover 50 crore large animals and 20 crore small animals in FMD vaccination programme.  ]]> https://biospectrumindia.com/news/22/24638/birac-announces-launch-of-regulatory-affairs-policy-advocacy-division.html https://biospectrumindia.com/news/22/24638/birac-announces-launch-of-regulatory-affairs-policy-advocacy-division.html Sat, 18 May 2024 00:00:00 +0530 To strengthen India's regulatory and policy milieu, Biotechnology Industry Research Assistance Council (BIRAC) announced a dedicated Regulatory Affairs & Policy Advocacy division during the BioNest Conclave on 17th May 2024 at the India International Centre (IIC), New Delhi. The aim of this division is to drive innovation through navigation of regulatory complexities, harmonisation of global regulations, and advocate for policies that catalyse the growth of startups, SMEs, and entrepreneurs in the dynamic landscape of regulatory and policy affairs. Dr Jitendra Kumar, Managing Director, BIRAC highlighted that this division will collaborate with Central Drugs Standard Control Organisation (CDSCO),Food Safety and Standards Authority of India (FSSAI), NITI Aayog and other stakeholders to foster an enabling and empowering ecosystem for the biotech community. During the launch, Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI), CDSCO spoke about the need of such an initiative and said that the regulations are not a restriction but a facilitation of innovative product development. Dr N. Kalaiselvi, Director General, Council of Scientific & Industrial Research (CSIR) & Secretary, Department of Scientific and Industrial Research (DSIR), congratulated BIRAC for creating this unit and emphasised the importance of regulations in translation of laboratory research to market ready products. Further, Prof. M. Jagadesh Kumar, Chairman, University Grants Commission (UGC) stressed upon the regulatory and policy knowledge in the universities and academic institutes of India. This initiative will foster innovation, drive collaboration, and advance the biotech ecosystem, said Dr Alka Sharma, Senior Advisor, Department of Biotechnology (DBT). "The unit will play a pivotal role in navigating the intricate regulatory landscape and ensuring the smooth execution of BIRAC's innovation focused objectives", concluded Dr Sonia Gandhi, Head- Regulatory Affairs & Policy Advocacy, BIRAC.   ]]> https://biospectrumindia.com/news/22/24599/department-of-pharmaceuticals-launches-meditech-stackathon-2024-in-collaboration-with-cii-.html https://biospectrumindia.com/news/22/24599/department-of-pharmaceuticals-launches-meditech-stackathon-2024-in-collaboration-with-cii-.html Tue, 07 May 2024 00:00:00 +0530 Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Dr Arunish Chawla, has launched the Meditech Stackathon 2024 in collaboration with Confederation of Indian Industry (CII). The Stackathon is a groundbreaking initiative designed to catalyse transformative change within India's burgeoning medtech sector by undertaking a comprehensive value chain analysis of select medical devices. Through close consultation with industry leaders, policymakers, and experts, the Stackathon aims to address critical challenges, foster domestic manufacturing, and reduce import dependence, thereby positioning India as a global leader in medical technology. The Stackathon would deliberate in eight focused groups namely Cancer Therapy, Imaging, Critical Care, Assistive Medical Devices, Body Implants, Surgical instruments and Hospital Equipment, Consumables & Disposables, and IVD Instruments and reagents, each tasked with specific objectives including segment-wise identification of important medical devices, assessment of import-export dynamics, examination of duty structures, and their implications across the entire value chain. ]]> https://biospectrumindia.com/news/22/24394/maharashtra-government-gives-re-recognition-to-medical-courses-at-colleges-of-physicians-and-surgeons-mumbai.html https://biospectrumindia.com/news/22/24394/maharashtra-government-gives-re-recognition-to-medical-courses-at-colleges-of-physicians-and-surgeons-mumbai.html Mon, 18 Mar 2024 00:00:00 +0530 The State Government of Maharashtra in consultation with Maharashtra Medical Council has announced significant amendments to the Maharashtra Medical Council Act, 1965. In a move aimed at expanding the scope of medical education and accreditation, the State Government, after extensive consultations with the Maharashtra Medical Council, has approved the reintroduction of 10 National Medical Commission (NMC) recognised courses offered by the Colleges of Physicians and Surgeons (CPS), Mumbai, into the schedule of the Maharashtra Medical Council Act, 1965. This development marks a significant milestone in the re-recognition and validation of the academic programmes offered by the institution. The amended schedule now includes a comprehensive list of courses offered by the Colleges of Physicians and Surgeons, Mumbai, which align with the standards set forth by the National Medical Commission. Notable inclusions encompass a range of membership and fellowship programs, as well as diploma courses, covering various medical specialisations such as Medicine, Pathology, Surgery, Dermatology, Obstetrics & Gynaecology, Ophthalmology and Child Health. "We always believed that de-recognition of CPS courses wasn't in the best interest of the Medical Fraternity, the healthcare system of the state and at  large the healthcare system of the country. Today our belief has been validated, all 10 NMC approved courses are now re-recognised by the Government of Maharashtra. With this notification not only CPS but the entire alumni of CPS and the future students have received justice , which was long due. This order will also benefit the healthcare system of the state. I would like to thank the Government of Maharashtra and the concerned authorities for their prudent decision," remarked CPS President Dr. Ajay D. Sambre.   ]]> https://biospectrumindia.com/news/22/24368/health-ministry-unveils-national-action-plan-for-prevention-and-control-of-snakebite-envenoming-.html https://biospectrumindia.com/news/22/24368/health-ministry-unveils-national-action-plan-for-prevention-and-control-of-snakebite-envenoming-.html Tue, 12 Mar 2024 00:00:00 +0530 Apurva Chandra, Union Health Secretary, has launched a National Action Plan for Prevention and Control of Snakebite Envenoming (NAP-SE) in India. With a vision to reduce snakebite deaths by half by 2030, NAPSE provides a broad framework for states to develop their own action plan for management, prevention and control of snakebites through the ‘One Health’ approach. The activities envisaged under human, wildlife, tribal and Animal health component will be undertaken by concerned stakeholders at all levels. It was informed that a Snakebite Helpline no (15400), a vital resource that provides immediate assistance, guidance, and support to individuals and communities affected by snakebite incidents will be piloted in five States (Puducherry, Madhya Pradesh, Assam, Andhra Pradesh and Delhi). This initiative aims to ensure prompt access to medical care and information to general public. A National Rabies Control Programme Website was also launched on the occasion. It is a comprehensive online platform dedicated to providing resources, updates, and insights on rabies. This website will serve as a digital platform for States/UT for entering information related to animal bite and rabies. This will also help the community to assess the nearest Anti Rabies Clinic and infectious disease hospital for management of animal bite and rabies cases. The website will also help in send the reminder SMS for vaccination follow up. ]]> https://biospectrumindia.com/news/22/24359/govt-announces-revamped-pharmaceuticals-technology-upgradation-assistance-scheme.html https://biospectrumindia.com/news/22/24359/govt-announces-revamped-pharmaceuticals-technology-upgradation-assistance-scheme.html Mon, 11 Mar 2024 00:00:00 +0530 The Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India, has announced the Revamped Pharmaceuticals Technology Upgradation Assistance (RPTUAS) Scheme. It is a significant step in government’s efforts to help upgrade the technological capabilities of the pharmaceutical industry and ensure its alignment with the global standards. The approval of the revised Scheme follows a comprehensive review by the Scheme Steering Committee in light of the requirements of the revised Schedule-M of the Drugs and Cosmetics Rule, 1945 as issued by the Department of Health & Family Welfare on 28 December 2023. The revised guideline aims to support the pharmaceutical industry's up-gradation to the Revised Schedule-M & WHO-GMP standards, enhancing the quality and safety of pharmaceutical products manufactured in the country. Reflecting a more inclusive approach, eligibility for the PTUAS has been expanded beyond Micro, Small and Medium Enterprises (MSMEs) to include any pharmaceutical manufacturing unit with a turnover of less than Rs 500 crore that requires technology and quality upgradation. Preference remains for MSMEs, supporting smaller players in achieving high-quality manufacturing standards. The scheme introduces a robust verification mechanism through a Project Management Agency, ensuring transparency, accountability and the efficient allocation of resources. ]]> https://biospectrumindia.com/news/22/24303/health-minister-inaugurates-greenfield-projects-under-pli-scheme-for-bulk-drugs-and-medical-devices.html https://biospectrumindia.com/news/22/24303/health-minister-inaugurates-greenfield-projects-under-pli-scheme-for-bulk-drugs-and-medical-devices.html Sat, 02 Mar 2024 00:00:00 +0530 Dr Mansukh Mandaviya, Union Minister for Chemicals & Fertilizers and Health & Family Welfare virtually inaugurated 27 greenfield bulk drug park projects and 13 greenfield manufacturing plants for medical devices. The PLI scheme for bulk drugs will lead to reduced import dependence and better supply chain resilience. Investment worth Rs 3,651 crore has already been grounded, till December 2023, by the scheme participants. PLI scheme envisages manufacturing of 41 Bulk Drugs with a total outlay of Rs 6,940 crore during the tenure of the scheme from 2020-21 to 2029-30. The inauguration of 13 Greenfield plants of companies such as Sahajanand Medical Technologies, Poly Medicure, Trivitron Healthcare, Wipro GE HealthCare, Siemens Healthcare, Panacea Medical Technologies etc. will be a big step towards achieving self-reliance in manufacturing of wide range of medical devices. 26 Applicants for manufacturing of Medical Devices have been approved for 138 products under the PLI scheme with total financial outlay of Rs 3,420 crore for the period 2020-21 to 2027-28. Highlighting the government’s efforts towards making India atmanirbhar in the field of critical medicines and active pharmaceutical ingredients (API), the Union Minister stated the example of Penicillin G, a widely used drug which were locally manufactured in India until the late 1980s. Due to globalisation, the import of Penicillin G led to the closure of all such plants in India. He highlighted that the Union Government is working on bringing back production of Penicillin G in India after three decades. The production is likely to begin in June 2024 by a Hyderabad-based enterprise. Dr Arunish Chawla, Secretary, Dept. of Pharmaceuticals (DoP) highlighted that under the PLI scheme, as many as 1800 pharmaceutical products and formulations and 22 bulk drugs will be manufactured in India. He also informed that when the PLI scheme came in, India imported 90% of medical devices. After the introduction of the PLI scheme, the net imports of medical devices decreased for the first time in 2023. ]]> https://biospectrumindia.com/news/22/24290/telangana-cm-urges-investors-to-look-for-tier-2-cities-for-more-pro-active-government-support.html https://biospectrumindia.com/news/22/24290/telangana-cm-urges-investors-to-look-for-tier-2-cities-for-more-pro-active-government-support.html Thu, 29 Feb 2024 00:00:00 +0530 Chief Minister (CM) of Telangana A. Revanth Reddy reiterated Telangana's status as the preferred destination for investments, affirming the government's commitment to extending all necessary support for industrial setups in both Hyderabad and the districts. This statement came during a special meeting held at the Hyderabad International Convention Centre (HICC) on the sidelines of the BioAsia 2024 conference (that took place from 26th to 28th February 2024), where delegates from various countries convened with the Chief Minister. While Reddy provided a comprehensive overview of Telangana's geographical advantages and highlighted the state's robust law and order situation, emphasising Hyderabad's reputation for unity in diversity, he urged investors to look for investment in Tier-2 cities for which the state government will come more proactively to support their initiatives. With Hyderabad already leading in sectors such as IT and pharma, the Chief Minister underscored the government's endeavors to propel the city to the forefront in other domains as well, attributing the growth of the pharma industry in Hyderabad to initiatives undertaken during the Congress leadership. Notably, Minister Sanderson from Western Australia expressed readiness to invest in the healthcare sector, highlighting the opening of India's first commercial office in Hyderabad. Discussions also ensued regarding investment opportunities in healthcare, health tourism, and health skilling.   ]]> https://biospectrumindia.com/news/22/24292/genome-valley-phase-ii-expansion-to-begin-in-hyderabad-with-rs-2000-cr-investment.html https://biospectrumindia.com/news/22/24292/genome-valley-phase-ii-expansion-to-begin-in-hyderabad-with-rs-2000-cr-investment.html Thu, 29 Feb 2024 00:00:00 +0530 Chief Minister (CM) of Telangana A. Revanth Reddy revealed plans for the establishment of Genome Valley Phase-II in Hyderabad, set to occupy an expansive area of 300 acres. This announcement came during the inauguration of the Healthcare and Life Sciences BioAsia 2024 conference at Hitex recently. The Chief Minister, accompanied by Industries and IT Minister D. Sridhar Babu, also honored Nobel Laureate Professor Greg L. Semenza with the prestigious Genome Valley Excellence 2024 Award. Chief Minister Reddy outlined the ambitious venture, stating that the Genome Valley Phase-II project would entail an investment of Rs 2000 crore. Additionally, the government has initiated the process of setting up ten pharma villages, with an investment totaling Rs one lakh crore. These initiatives are anticipated to generate employment opportunities for approximately 500,000 individuals. The new Genome Valley facility is poised to be established across greenfield pharma clusters in Vikarabad, Medak, and Nalgonda districts. Highlighting its strategic location in proximity to the Hyderabad International Airport, CM emphasized the convenience it offers to global entrepreneurs. He also emphasised the need for collaborative efforts to address global health challenges, reaffirming the government's commitment to bolster Hyderabad's status as a hub for IT, research, startups, and biosciences.  In a testament to Hyderabad's appeal as a destination for investment, Chief Minister Reddy highlighted the substantial investments garnered during the recent World Economic Forum at Davos, amounting to Rs 40,232 crore. Notably, he welcomed the collaboration between Takeda and Biological-E companies to produce five crore vaccine doses annually, further enhancing Hyderabad's reputation as a leading vaccine production hub. ]]> https://biospectrumindia.com/news/22/24297/cabinet-approves-director-position-to-spearhead-national-one-health-mission.html https://biospectrumindia.com/news/22/24297/cabinet-approves-director-position-to-spearhead-national-one-health-mission.html Thu, 29 Feb 2024 00:00:00 +0530 The Union Cabinet chaired by Prime Minister Narendra Modi has approved the proposal of creation of one post at the level of Scientist H (in the pay level 15) as Director of National Institute of One Health, Nagpur who will also serve as the Mission Director for the multi-Ministerial and multi-sectoral National One Health Mission for integrated disease control and pandemic preparedness, by bringing human, animal, plant and environmental sectors together. The creation of one post of Director of National Institute of One Health at the level of Scientist 'H' in the pay level 15 (Rs 1,82,000 - Rs 2,24,100) will have the annual financial implications of approx. Rs 35.59 lakh. A programme for strengthening research and development towards integrated diseases central and pandemic preparedness for the National One Health Mission has already been approved on 01.01.2024. The National One Health Mission will help India to achieve integrated disease control and pandemic preparedness by institutionalising the One Health approach. It will also leverage the ongoing/planned programmes of different Ministries/Departments by fostering collaborations to address health of humans, animals, plants and environment holistically and in a sustainable manner.   ]]> https://biospectrumindia.com/news/22/24279/ministry-of-ayush-inks-mou-with-research-and-information-system-for-developing-countries.html https://biospectrumindia.com/news/22/24279/ministry-of-ayush-inks-mou-with-research-and-information-system-for-developing-countries.html Tue, 27 Feb 2024 00:00:00 +0530 The Ministry of Ayush and Research and Information System for Developing Countries, (RIS) New Delhi have signed a Memorandum of Understanding (MoU). This MoU will bring forth the overview of Ayush Service sector and will serve the continuation of academic cooperation and collaboration with RIS (a Policy Research autonomous institute of Ministry of External Affairs). Secretary, Vaidya Rajesh Kotecha signed the MoU on behalf of Ministry of Ayush, whereas Director General, Prof Sachin Chturvedi was the signatory on behalf of RIS. This Knowledge Partnership, through this MoU, will not only serve to strengthen academic cooperation and collaboration to undertake research, policy dialogue, and publications for national, regional and international, and capacity building in the field of Indian Traditional Medicine, but will also bring out Ayush Service Sector overview in a time bound frame. Also the academic cooperation between Ministry of Ayush and RIS includes continuance of Forum on Indian Traditional Medicine (FITM).  There is a continuous need of having an inclusive and broad overview of market estimates, products standardisation, regulations etc. in international trade, and FITM is working towards it. ]]> https://biospectrumindia.com/news/22/24238/ayush-and-tribal-affairs-ministries-partner-to-focus-on-public-health-of-tribal-students.html https://biospectrumindia.com/news/22/24238/ayush-and-tribal-affairs-ministries-partner-to-focus-on-public-health-of-tribal-students.html Wed, 21 Feb 2024 00:00:00 +0530 To make India a self-reliant nation, we have to make every Indian disease-free, Union Minister of Ayush and Ports, Shipping and Waterways Sarbananda Sonowal stated at New Delhi during the announcement of the joint National Level Project of Health Screening and Management through Ayurvedic Interventions. This project will benefit over 20,000 Tribal Students. The Ministry of Ayush through its research council Central Council for Research in Ayurvedic Sciences (CCRAS) has taken this health Initiative for Tribal students with the joint initiative of Ministry of Tribal Affairs and ICMR-National Institute of Research in Tribal Health (NIRTH) Jabalpur. During the announcement, Union Minister of Tribal Affairs Arjun Munda was also present. The project aims at screening the general health condition of the students enrolled in classes 6th to 12th. The screening will be carried out in selected 55  Ekalavya Model Residential Schools (EMRS) spread across 14 states of the country. The special focus is on Anaemia, Haemoglobinopathies, Malnutrition & Tuberculosis. Efforts will be made to inculcate healthy lifestyle practices among students as per the principles of Ayurveda. Also, an integrated approach will be made for the management of the diseases. ]]> https://biospectrumindia.com/news/22/24228/niti-aayog-releases-report-for-senior-care-reforms-in-india.html https://biospectrumindia.com/news/22/24228/niti-aayog-releases-report-for-senior-care-reforms-in-india.html Mon, 19 Feb 2024 00:00:00 +0530 NITI Aayog has released a position paper titled 'Senior Care Reforms in India: Reimagining the Senior Care Paradigm'. The report was released by NITI Aayog Vice Chairman Suman Bery in the presence of Member (Health) Dr Vinod K. Paul; CEO B. V. R. Subrahmanyam; and Department of Social Justice and Empowerment (DoSJE) Secretary Saurabh Garg. Speaking on the occasion, NITI Aayog Vice Chairman Suman Bery said, “The release of this report is one of the stepping stones toward India’s commitment to achieve the goal of Viksit Bharat @2047. It is important to extensively prioritise the application of technology and Artificial Intelligence for senior care. It is time to start thinking about the special dimensions of senior care in addition to the medical and social dimensions.”. “This is the time when serious discussions should emerge on making ageing dignity driven, safe, and productive. We need to ensure the social security of the elderly and add more emphasis to wellbeing and care,” mentioned Member (Health) NITI Aayog Dr V.K. Paul in his address. “Role of family and family values is crucial in developing an ecosystem for healthy ageing. The report has brought forth appropriate policy directives for healthy ageing in India,” stated CEO, NITI Aayog B.V.R. Subrahmanyam. Saurabh Garg, Secretary, Department of Social Justice and Empowerment (DoSJE) said, “The report is a call for action on what needs to be done to bring a greater focus on senior care.”. He added that the broad focus of DoSJE is on ageing with dignity, ageing at home, and productive ageing, which will encompass social, economic, and health aspects.”. The recommendations in this position paper categorise the specific interventions needed in terms of empowerment, service delivery, and their inclusions under four core areas: Health, Social, Economic/ Financial, and Digital. It strives to push the frontiers of senior care by recognising the evolving medical and non-medical needs of seniors, thus envisioning a multi-pronged strategy for designing an effective and synergised senior care policy. ]]> https://biospectrumindia.com/news/22/24208/health-ministry-inks-mou-for-implementation-of-sbi-aiims-new-delhi-smart-card-system.html https://biospectrumindia.com/news/22/24208/health-ministry-inks-mou-for-implementation-of-sbi-aiims-new-delhi-smart-card-system.html Tue, 13 Feb 2024 00:00:00 +0530 Union Minister for Health & Family Welfare and Chemicals & Fertilizers, Dr Mansukh Mandaviya launched the AIIMS-SBI Smart Payment Card, in New Delhi. The AIIMS-SBI Smart Payment Card will ensure hassle free payments for treatment in All India Institute of Medical Sciences (AIIMS) New Delhi. A Memorandum of Understanding (MoU) with regards to implementation of the SBI- AIIMS New Delhi Smart card system was also signed. Speaking on the occasion, the Health minister highlighted that the “AIIMS Smart Payment Card will resolve the long pending issue of patients from far flung areas carrying cash with them to the hospital.” He added that patients or their caretakers can get the card easily from the facilitation centres across AIIMS, New Delhi and thereafter use it for payment at various counters. Hailing the launch as a major step in patient care services and the Digital India initiative under the leadership of Prime Minister Narendra Modi, Dr Mandaviya stated that the Digital India initiative has ushered in a new era of ease and safety which was very elusive earlier and is still a distant goal for many countries.   Referring to the Smart Payment Card as ‘One AIIMS, One Card,’ the Union Minister added that funds can now be transferred easily and swiftly from across the country by anyone in case of any urgent payment related requirement, for the patient being attended at AIIMS, New Delhi. He also informed that in near future the services of these cards will be extended across all the AIIMS in the country. He further reiterated the centre’s commitment towards adding further convenience measures for patients across the hospitals in the country.   ]]> https://biospectrumindia.com/news/22/24198/netherlands-ambassador-explores-investment-opportunities-with-telangana-government.html https://biospectrumindia.com/news/22/24198/netherlands-ambassador-explores-investment-opportunities-with-telangana-government.html Mon, 12 Feb 2024 00:00:00 +0530 Marisa Gerards, the Netherlands Ambassador in India, along with Head of Economic Affairs Joost Geijer and INBA H (India-Netherlands Business Association) Chairman Chakravarthi AVPS, held a productive meeting with the Chief Minister of Telangana Revant Reddy, Minister Komatireddy Venkata Reddy, Chief Secretary of the State Shanti Kumari, Spl Chief Secretary Ramakrishna Rao, and other officials to discuss the strong bilateral ties between the Netherlands and India. The discussions primarily focused on exploring opportunities for Dutch investment in India, underscoring the favorable business environment in the country. Potential collaborations in the agriculture and water sectors were explored, including initiatives such as the Agricultural Centers of Excellence and the Musi River rejuvenation project. Additionally, avenues for growth in the Pharma & Biotech sectors were discussed. Chakravarthi, who also chairs the Federation of Pharma Entrepreneurs, Telangana & Andhra Pradesh, highlighted the significant pharmaceutical exports from India to the Netherlands, amounting to approximately $600 million, with 70% comprising formulations. He mentioned a recent Memorandum of Intent (MoI) signed between the Central Drugs Standard Control Organisation (CDSCO) of India and the Ministry of Health, Welfare and Sport of the Netherlands. This MoI aims to establish a framework for cooperation and information exchange in the field of Medical Products Regulation, facilitating trade growth and fostering better collaboration between the two countries in the pharmaceutical sector. The meeting between the Netherlands delegation and Telangana government officials signifies a step forward in strengthening economic ties and exploring avenues for mutual growth and cooperation between the two nations. ]]> https://biospectrumindia.com/news/22/24171/centre-strengthens-public-health-infrastructure-in-maharashtra-and-gujarat.html https://biospectrumindia.com/news/22/24171/centre-strengthens-public-health-infrastructure-in-maharashtra-and-gujarat.html Fri, 09 Feb 2024 00:00:00 +0530 Prof. S P Singh Baghel and Dr Bharati Pravin Pawar, Union Ministers of State for Health and Family Welfare virtually launched the Kilkari programme, a Mobile Health (m-health) initiative for beneficiaries in local content in Gujarat and Maharashtra.  Mobile Academy, a free audio training course designed to expand and refresh the knowledge of Accredited Social Health Activists (ASHAs) and improve their communication skills via their mobile phones was also launched.  The ‘Kilkari’ programme aims to offer weekly services, timely accessible, accurate and pertinent 72 audio messages through Interactive Voice Response System (IVRS) about reproductive maternal, neonatal and child healthcare to the targeted beneficiaries. It is centrally hosted by Ministry of Health and Family Welfare (MoHFW) for all the States/UTs and no further investment in the technology, telephony infrastructure or operational costs is required to be borne by States/UTs. This service is free of cost for States/UTs and beneficiaries. The programme is integrated with centralised Reproductive Child Health (RCH) portal of MoHFW and is the single source of information for this mHealth service. Currently Kilkari is under implementation in 18 States / UTs namely Andhra Pradesh, Andaman & Nicobar Islands, Assam, Bihar, Chhattisgarh, Chandigarh, Delhi, Haryana, Himachal Pradesh, Jammu & Kashmir, Jharkhand, Madhya Pradesh, Odisha, Rajasthan, Tripura, Uttar Pradesh, West Bengal and Uttarakhand  & Mobile Academy is operational in 17 States/UTs except Chandigarh with six languages viz. Hindi, Bhojpuri, Oriya, Assamese, Bengali & Telugu version. ]]> https://biospectrumindia.com/news/22/24160/health-ministry-announces-opening-of-new-headquarters-of-national-dental-commission.html https://biospectrumindia.com/news/22/24160/health-ministry-announces-opening-of-new-headquarters-of-national-dental-commission.html Wed, 07 Feb 2024 00:00:00 +0530 In a significant step towards dental healthcare, the Union Minister of Health and Family Welfare Dr Mansukh Mandaviya inaugurated the new headquarters of the National Dental Commission (NDC) in Delhi, and laid the foundation stones for three Nursing Colleges in Andhra Pradesh and one in Jammu and Kashmir virtually. Additionally, Dr Mandaviya presided over the signing of Memorandum of Understanding (MoU) between the Dental Council of India and Quality Council of India for the assessment and rating of undergraduate dental colleges and launched the National Dental Register under the National Health Digital Mission. Dr Mandaviya was joined by Dr Manik Saha, Chief Minister of Tripura and Manoj Sinha, Lieutenant Governor of Jammu and Kashmir joined virtually. Through the Dental Commission Act, the government has made an effort to make dental education more practical, affordable and bring transparency in the entire system, simultaneously providing patients with affordable and good treatment. Addressing the gathering, the Union Health Minister emphasised that with the launch of National Dental Register (NDR) created under One Nation One Register, the people of the country will get the identity and qualification of dentist in a transparent manner. He further added “NDR will provide Unique Identification (DCI ID) to all dentists practicing in India after verification from the respective State Dental Council. The NDR will also help citizens identify dentists verified by state dental councils.” ]]> https://biospectrumindia.com/news/22/24150/interim-budget-2024-25-immunisation-initiatives-and-women-empowerment-take-centre-stage.html https://biospectrumindia.com/news/22/24150/interim-budget-2024-25-immunisation-initiatives-and-women-empowerment-take-centre-stage.html Thu, 01 Feb 2024 00:00:00 +0530 The Indian economy has witnessed profound positive transformation in the last ten years, stated Nirmala Sitharaman, Minister of Finance, while presenting the Interim Budget 2024-25 earlier today. Focusing on the healthcare aspect, the Minister said that the government will encourage vaccination for girls in age group of 9 to 14 years for prevention of cervical cancer.  Various schemes for maternal and child care will be brought under one comprehensive programme for synergy in implementation. Upgradation of anganwadi centres under “Saksham Anganwadi and Poshan 2.0” will be expedited for improved nutrition delivery, early childhood care and development. The newly designed U-WIN platform for managing immunisation and intensified efforts of Mission Indradhanush will be rolled out expeditiously throughout the country. Healthcare cover under Ayushman Bharat scheme will be extended to all ASHA workers, Anganwadi Workers and Helpers.  "A corpus of Rs one lakh crore will be established with fifty-year interest free loan. The corpus will provide long-term financing or refinancing with long tenors and low or nil interest rates. This will encourage the private sector to scale up research and innovation significantly in sunrise domains. We need to have programmes that combine the powers of our youth and technology", said the Minister. Emphasising on women empowerment, the Minister stated that thirty crore Mudra Yojana loans have been given to women entrepreneurs. "Female enrolment in higher education has gone up by twenty-eight per cent in ten years. In STEM courses, girls and women constitute forty-three per cent of enrolment - one of the highest in the world. All these measures are getting reflected in the increasing participation of women in workforce", she added. With focus on Yuva Shakti and marching towards the goal of Viksit Bharat by 2047, Nirmala Sitharaman proposed setting up of more medical colleges. The new medical colleges will be set up by utilising the existing hospital infrastructure under various departments.  A committee will be set up for this purpose to examine the issues and make relevant recommendations. Interim Budget also proposes a new scheme of bio-manufacturing and bio-foundry which will provide environment friendly alternatives such as biodegradable polymers, bio-plastics, bio-pharmaceuticals and bio-agri-inputs.   Click here to read the industry's responses ]]> https://biospectrumindia.com/news/22/24151/industry-responds-to-interim-budget-2024-25-highs-lows.html https://biospectrumindia.com/news/22/24151/industry-responds-to-interim-budget-2024-25-highs-lows.html Thu, 01 Feb 2024 00:00:00 +0530 Chandra Ganjoo, Group Chief Executive Officer, Trivitron Healthcare "Addressing public health concerns, the government advocates for the vaccination of girls aged 9-14 against cervical cancer. This initiative, focusing on awareness, early HPV screening, and vaccination, aims to empower females to enhance their reproductive health and protect against the consequences of cervical cancer."   Pavan Choudary, Chairman, Medical Technology Association of India (MTaI) & Managing Director, of Vygon India “The schemes for maternal and childcare which are currently in place are disparate and sometimes deficient. Bringing them under one common, standardised platform would help deliver optimal and comprehensive care throughout India. While the customs duty has not gone down which was our expectation, and remains at the same level, this itself will take FDI in MedTech to a never-before high this financial year. However, if the government had reduced the customs duties, the FDI in MedTech could have taken a meteoric trajectory."    Dr Garima Sawhney, Co-founder, Pristyn Care “The Finance Minister has allocated 30 crore MUDRA Yojana loans to women entrepreneurs. This is going to elevate women entrepreneurship and boost startup ecosystem that will definitely make the Indian economy reach greater heights."   Satish Reddy, Chairman, Dr. Reddy's Laboratories  “The interim budget's emphasis on ease of doing business and local manufacturing are welcome. In particular, the Rs 1 lakh crore R&D allocation for sunrise sectors can potentially act as a catalyst in our innovation journey as the Indian pharma industry aims to reach $120-130 billion by 2030."   Partha Pratim Das Mahapatra, Founder and CEO, EzeRx "The Interim Budget of 2024 marks a significant boon for the healthcare industry, particularly benefiting the rural areas where the need is greatest. The government's strategic initiatives, notably Mission Indradhanush, exemplify a transformative commitment to immunize against measles, polio, hepatitis B, tetanus, diphtheria, TB, and pertussis, empowering women and securing a brighter future for children."   Kiran Mazumdar Shaw, Executive Chairperson, Biocon & Biocon Biologics   “In the Interim Union Budget 2024-25, Finance Minister Nirmala Sitharaman has provided a comprehensive roadmap for sustained economic growth that will enable India to achieve a developed economy status by 2047. Her emphasis on research & innovation, bio manufacturing, green technology, robust infrastructure development and technology-driven digital transformation augur well for India to deliver on aspirational yet people-centric, inclusive development.” A Ganesan, Vice Chairman, Neuberg Diagnostics "Recognising a significant shortfall of doctors and surgeons across various regions of India, the budget for 2024 outlines plans to establish additional medical colleges. Leveraging existing hospital infrastructure under different departments, this strategic move aims to address the scarcity of medical professionals, ultimately contributing to an enhanced healthcare landscape."   Sanjay Bhutani, Board Member, MTaI & Managing Director, Bausch & Lomb "With schemes like cervical cancer vaccination for younger girls and covering Anganwadi and Asha workers under Ayushman Bharat, this budget emphasized on healthcare, especially for women, adolescents, and children. Also, the plan to increase the number of medical colleges using the existing infrastructure will surely enhance the healthcare facilities in tier 2 tier 3 cities. However, we feel if customs duty on medical devices were reduced, India would further its journey to become the global hub for medical tourism. Also, we were expecting the Direct taxes and personal income taxes to go down which would have attracted more FDI and put more money in the hands of consumers, respectively."    Anil Matai, Director General, Organisation of Pharmaceutical Producers of India (OPPI) "While we appreciate the positive strides taken in the Union Budget 2024 towards the healthcare and pharmaceutical sector, we were also hoping that a nuanced approach to reduce duty/tax burdens on innovative & lifesaving drugs, addressing regulatory challenges and facilitating ease of doing business could have been outlined."   D. S. Negi, CEO, Rajiv Gandhi Cancer Institute & Research Centre (RGCIRC) "We welcome the interim budget announcement pertaining to the health sector, and hope the government will prioritise other pressing issues in the healthcare sector and provide budgetary incentives in the upcoming full budget."   Dr Saloni Wagh, Director, Supriya Lifescience "We warmly welcome the government's four central pillars of economic development, particularly its efforts to empower women, youth, and improve the livelihoods of the underprivileged and farmers. The success of initiatives like the Mudra Yojana loans and the significant rise in female enrollment in higher education and STEM courses mark commendable milestones in women's empowerment."   Dheeraj Jain, Founder, Redcliffe Labs  "The significance of this budget extends beyond mere numbers, for it promises to fortify our hospitals' infrastructure and streamline schemes dedicated to children and maternal health."   Krishna Mohan, Regional President for MEIA Region, Novonesis “The Government of India’s increased focus for a robust green economy is encouraging, with a new scheme for biomanufacturing and bio-foundry sectors for promoting eco-friendly alternatives like degradable polymers, bioplastics, biopharmaceuticals, and biological agri inputs. Additionally, mandating phased blending of compressed biogas (CBG) in compressed natural gas (CNG) for transport and piped natural gas (PNG) for domestic purposes is encouraging."   Dr Kshitiz Murdia – CEO & CO-Founder of Indira IVF "One of the applauding factors was establishing a 1 lakh crore corpus for loans over a period of fifty years which would be interest free. This will encourage innovation and research in the area of medical treatment as well, inciting better clinical outcomes, increasing treatment possibilities in India, and encouraging medical tourism.”   Dr Ashutosh Raghuvanshi, MD and CEO, Fortis Healthcare & President, NATHEALTH "The 2024 budget takes a forward-looking approach to healthcare. However, it's worth mentioning that some long-standing demands, like GST rationalisation and increased investments in the healthcare sector, needs to be addressed. We anticipate their consideration in the upcoming comprehensive budget."   Ameera Shah, Promoter and Managing Director, Metropolis Healthcare "The Interim budget takes commendable steps in healthcare. We had hoped for deeper investment and resource allocation in the healthcare sector. India should prioritise and invest more in healthcare, exploring Public-Private Partnerships to enhance services without significantly increasing budgets. There is a need for regular and inclusive screening, along with more skilling courses for healthcare professionals to attract and upskill talent in the healthcare space. Additionally, the diagnostic sector requires a 0% GST on services and refunds for GST paid on inputs."   Sigal Atzmon, CEO & Founder, Medix Global "While there are still gaps in certain areas, the Union Budget's dedicated focus on consolidating maternal and child health schemes reflects a wise approach to streamlining care delivery. Additionally, the announcement encouraging vaccination for girls to prevent cervical cancer is a proactive step towards prioritising preventive healthcare for women."    Jasdeep Singh, Group CEO, CARE Hospitals Group "The 'U-Win' platform for managing immunization, along with the intensification of Mission Indradhanush, will be rapidly implemented across the country. The government's multifaceted approach in this budget underscores a dedication to quality healthcare, particularly in tier II cities and rural regions."   Dr Azad Moopen, Founder and Chairman - Aster DM Healthcare  "In healthcare we were hoping to see an increase in the GDP allocation of minimum 5% for the sector, hopefully this will be addressed in the complete Budget to be announced in July this year, under the new government. We are glad that the government is considering to add more hospitals in all districts in the country, which is essential to meet the rising demand. We would recommend focusing on public-private partnerships (PPP) to address this. With all maternal and child healthcare to be brought under one- scheme, this will be essential."   Vaibhav Tewari, CEO & Co-Founder, Portea Medical "There were several other key expectations that have remained unaddressed such as expansion of insurance coverage to outside of hospital care, funding, support for tech-driven healthcare sector, and healthcare startups etc. Since this is an interim budget, it seems that barring some of the operational needs, major policy initiatives have been left out for the full annual Budget that will be presented after the elections this year."   Dr Shafiq AM, Co-Founder and CEO, Trilife Hospital  "We are hopeful that the full budget later in the year will support innovation and R&D and rationalise the GST Framework and tax incentives for private sector participation in healthcare infrastructure development."     Abrarali Dalal, Director & CEO, Sahyadri Hospitals  "The absence of specific allocations for AI in healthcare in this year's budget, despite the previous focus on setting up a Center of Excellence in AI for health, overlooks the potential of AI in diagnostics and medical advancements."   Prashant Arer, India Head, Enbio Group AG "The tax rationalisation would be necessary to gear up for an aspirational $50 billion MedTech economy. The heavy import duties on medical equipment affect operational costs. The MedTech industry was expecting a reduction of import duties, creating a win-win situation for both manufacturers and large hospitals.”     Rustom Lawyer, CEO and Co-Founder, Augnito "Expanding healthcare coverage to ASHA and Anganwadi workers is commendable, but the absence of concrete AI plans leaves some uncertainty. Perhaps these will be addressed in the July budget, but the focus on "deep tech" for defense suggests the government recognizes the strategic importance of such technologies."   Dr Gayati Kamineni, Chief Operating Officer, Kamineni Hospitals "We are disappointed with the absence of GST reductions on essential medicines and tax concessions on generic pharmaceuticals in the budget. Affordable healthcare is vital, and these measures reduce the burden on patients while encouraging innovation. We urge the government to rethink these aspects to ensure equitable access to essential medicines."   Behram Khodaiji, CEO, Ruby Hall Clinic "Investing in the health of our young girls is an investment in the future of our society, as the budget focuses on poor, women and youth who are the pillars of our country.”   Dr Mayank Aggarwal, medical oncologist, Venkateshwar Hospital, New Delhi "HPV vaccination will play a role in lowering the incidence of other cancers, such as head and neck, anal cancer, and various gynecological cancers."   Amol Naikawadi, Joint Managing Director and Preventive Health Specialist, Indus Health Plus “The 2024 Union budget combines optimism with cautious reflection for healthcare, showcasing a 13% increase from the previous fiscal year. This rise suggests potential for addressing critical gaps in healthcare and infrastructure."   Srivardhan Khemka, Director, Sanjivani Paranteral "To catalyse innovation in sunrise domains, a landmark initiative unfolds with the establishment of a one-lakh crore corpus, offering a fifty-year interest-free loan. This move facilitates long-term financing with extended tenors and minimal interest rates. This intent empowers the private sector in scaling up research and innovation significantly and brings together the powerful forces of our youth and technology, resulting in developments that will significantly boost the pharmaceutical and biotech industries to prosper in a dynamic landscape of innovation and discovery."   Koji Wada, Managing Director, Fujifilm India "This budget signals a holistic approach to healthcare services, addressing immediate needs while laying the foundation for a robust healthcare system in the coming years."   Meera Iyer, CEO & Co-Founder, SkinQ  "While the budget introduces commendable measures such as improving healthcare, nutrition, and providing financial support for women entrepreneurs, there's a pressing need for greater funding allocation specifically for women startup founders."   Dr Prathap C. Reddy, Chairman, Apollo Hospitals "I welcome the strategy to augment medical education by capitalizing on existing hospital infrastructures. In doing so, we are not only paving the way for an increased number of medical and nursing colleges, but also enhancing the capacity for para-medical training. Further, with the emphasis on skilling, India will emerge as a beacon for global workforce development, bringing financial stability to families and attracting foreign exchange."   Dr Neerja Agarwal, Psychologist and Co-founder, Emoneeds  "While the interim budget lacked specific policies or initiatives for the mental health sector, we remain optimistic that post-election, the full budget will address this critical area. With approximately 150 million Indians requiring mental health care services and a stark shortage of professionals – only 0.3 psychiatrists, 0.07 psychologists, and 0.07 social workers per 100,000 people – the need is urgent."   Lovekesh Phasu, Group COO, Sakra World Hospital, Bengaluru  "Greater emphasis on budgetary allocations for healthcare infrastructure, telemedicine expansion, medical research funding, could have significantly enhanced accessibility and healthcare delivery across the nation."   Deepak NG, Managing Director, Dassault Systemes India  "The focus on cervical cancer vaccination, Mission Indradhanush and upgradation of anganwadi centres, is a positive step towards ensuring a healthier and more sustainable future for everyone."    Munira Loliwala, AVP - Strategy and Growth, TeamLease Digital  "Better investments in devices and R&D schemes are awaited from the Government to advance telemedicine, virtual assistants and data analytics that is expected to create 2.7-3.5 million new technology jobs with demand for talent like data scientists and AI specialists."    Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) "Supporting policies are needed so that Indian Medical Devices Industry can make quality healthcare accessible and affordable for the common masses, aim to place India among the top five medical devices manufacturing hubs worldwide and help end the 80-85 per cent import dependence forced upon us and an ever-increasing import bill of over Rs 63,200 crore."   Anish Bafna, CEO and MD, Healthium Medtech  "Pragmatic guidelines are still required to prioritise the adoption of the latest technologies for better clinical outcomes and improving patient centricity."   Nikhil Chopra, CEO & Whole Time Director, JB Pharma "The forward-thinking emphasis on women's health, particularly in preventing cervical cancer, aligns seamlessly with the global push for eradicating preventable diseases. These initiatives, complemented by a comprehensive Maternal and Child health care agenda and the extension of Ayushman Bharat to ASHA and Anganwadi workers, underscore the government's forward-looking approach towards women's health."   Harish Trivedi, CEO, Cancer Treatment Services International (CTSI) – South Asia "Most advanced nations have either eliminated or are on the verge of eliminating the cervical cancer through effective vaccination against HPV, a major cause of cervical cancer. For all women aged between 9 to 14 years if vaccinated effectively the disease can be eliminated within one generation."   Tarun Gupta, Co-Founder, Lissun "Commendably, there is a strong commitment to Research and Development (R&D) with a substantial 1-lakh crore corpus allocated to the private sector. Additionally, India’s leadership is evident in STEM courses, boasting an impressive 43% women enrollment. However, as we await the post-election full budget, there’s a need for specific attention to the mental health sector. Allocating resources for infrastructure, qualified professionals, research, and destigmatization campaigns is imperative to address to escalating mental health crisis in India."   Raj Gore, CEO, Healthcare Global Enterprises "I appreciate the government’s push for a comprehensive health development for women in this budget. The emphasis on promoting cervical cancer vaccination for girls aged 9-14 is a pivotal step towards raising awareness and taking preventive measures to reduce cervical cancer burden in India. However, I strongly recommend an increased allocation to the healthcare sector in the upcoming post-election budget."   Sakshi Bakshi, CEO, EPIA (Healthcare) "The surge in women’s enrolment in STEM courses is a positive leap, and the expanded ‘Lakhpati Didi’ initiative showcases a commitment to economic empowerment of women at grassroots level. Importantly, the allocation of a 1-lakh crore corpus for interest-free long-term financing demonstrates a dedication to fostering private sector R&D. This strategic move has the potential to open doors for women, allowing them to assume pivotal roles in shaping the future of technology, science, and engineering."   Joy Chakraborty, Chief Operating Officer, P. D. Hinduja Hospital and Medical Research Centre "The budget's healthcare emphasis aligns seamlessly with our operational goals, emphasising the establishment of new medical colleges and the optimization of existing facilities. A committee has also been formed to recommend the establishment of additional medical colleges. Collaborative initiatives between selected ICMR Labs and faculty from diverse sectors enhance medical research, contributing significantly to the advancement of a healthier India, especially as elections approach."   Shweta Rai, Director, Bayer Zydus Pharma and Country Division Head for Bayer’s Pharmaceuticals Business in South Asia "We welcome the move to improve the rate of HPV vaccination in the country and integrate schemes for maternal health and childcare under one umbrella will help to streamline the implementation of both schemes and improve the impact on women's and children’s health. We look forward to more announcements and opportunities in the upcoming Union Budget that would prioritize women’s health along with research and innovation to improve the pharma landscape in the country.“    Sandeep Verma, Country Head, Bayer Consumer Health Division, India "We look forward to more allocations in the upcoming Union Budget 2024 to promote responsible self-care practices and further strengthen the primary care infrastructure in India that increases access to healthcare for all. "   Vikram Thaploo, CEO-Telehealth, Apollo Hospitals "We welcome the significant healthcare initiatives announced in the Union Budget 2024-25, particularly the establishment of more medical colleges using existing infrastructure. This step will undoubtedly address the critical need for more healthcare professionals and enhance the overall medical infrastructure of our nation."   Sanjiv Navangul, Managing Director & CEO, Bharat Serums and Vaccines  “We are encouraged with the recent budget announcement that lays emphasis and much-deserved attention on women’s health.  With all maternal and child healthcare schemes under one comprehensive programme, the collective vision of Healthy Women, Healthy Pregnancies and Healthy Future is turning into reality. Added to this, HPV vaccinations for girls in the 9-14 age group for the prevention of cervical cancer, immunisations of children, and schemes such as Poshan 2.0 will help improve nutrition delivery, early childhood care, and development."   Sanjay Vyas, Executive Vice President and Managing Director, Parexel India "Though there were no major announcements for the clinical trials or the pharmaceuticals sector, initiatives to set up more medical colleges by utilising the existing hospital infrastructure is highly commendable. This would attract more industry-academia partnerships for clinical research organizations and facilitate a larger research pool. It will also facilitate closer collaboration between clinicians and researchers, and establish a more affordable infrastructure. Additionally, the emphasis on innovation and technological advancements will be highly beneficial for innovation in the healthcare sector at large. We hope that in the next budget after the elections, the government increases public healthcare spending to 2.5% of GDP.”   Rahul Cordeiro, Chief Financial Officer, GE HealthCare South Asia "The Union Budget FY 2023-24 promising an increased outlay of Rs 1 Lakh crore for sunrise sectors like MedTech is encouraging for the industry as we strengthen our march towards Atmanirbhar Bharat, envisioning to become the global manufacturing and MedTech hub. We also expect to see incentives and rebates for medical devices to make them globally competitive and enhance exports; coupled with the facilitation of single-window clearances for local manufacturers."   Dr Anand Kumar, Managing Director, Indian Immunologicals "The introduction of the U-WIN platform for immunisation is a testament to the government's unwavering commitment to streamline vaccination efforts and enhance coverage rates nationwide."   Surajit Chakrabartty, CFO, MedGenome "The consolidation of maternal and child healthcare schemes into a comprehensive programme is a positive move, streamlining efforts for improved outcomes. However, as we have been advocating, genetic tests like Noninvasive Prenatal Testing (NIPT) and Carrier Screening Tests are vital to keep a check on the rising disease burden, especially rare diseases and to build a healthier generation."   Gaurav Srivastava, Co-Founder & COO, HaystackAnalytics "While there are positive announcements, we are optimistic that the final budget in July 2024 will explore avenues to address much-needed  emphasis on local innovations with reduction in imports and increased focus on R&D for the advanced diagnostic industry.”   Nikkhil K Masurkar, CEO, Entod Pharmaceuticals "While no specific announcements were made towards the pharma sector, these healthcare initiatives outlined in the 2024-2025 Union Budget are encouraging and have the potential to usher in a new era in healthcare. However, as pharmaceutical professionals, we were anticipating more substantial capital investment directed towards pharmaceutical research and development."   Dr Ashay Karpe, Founder & Director, Sunrise Oncology Centre "The expansion of medical and nursing colleges heralds a new era of healthcare workforce development, nurturing the talent needed to address evolving healthcare challenges and meet the diverse needs of our population. Moreover, the implementation of fiscal reforms in the health insurance sector underscores a commitment to enhancing coverage and affordability, ensuring that individuals can access essential services without financial strain."   Dheer Shah, CFO, BDR Pharmaceuticals  "Consolidating maternal and child healthcare schemes echoes a harmonised vision for streamlined implementation and amplified impact. Simultaneously, the impetus on bio-manufacturing and bio-foundry heralds a sustainable paradigm shift, where innovation converges with environmental stewardship."   Dhrubaa Ghosh, Partner, Management Consulting, BDO India "The aim to expand the number of medical colleges utilising the existing infrastructure to have more qualified doctors is a great move to meet the demand for better quality of care. There is a need to meet the doctor to people ratio adequately in order to treat the 1.3 billion Indians."   ]]> https://biospectrumindia.com/news/22/24107/odisha-govt-approves-biotechnology-policy-2024-to-enhance-state-ecosystem.html https://biospectrumindia.com/news/22/24107/odisha-govt-approves-biotechnology-policy-2024-to-enhance-state-ecosystem.html Wed, 24 Jan 2024 00:00:00 +0530 The government of Odisha has approved the Biotechnology Policy 2024 to create a flourishing ecosystem for the biotech industry. This will further promote higher education, research & infrastructure development in the sector and strengthen the supportive ecosystem for innovation, incubation, investment, income & impact to build enterprises. Association of Biotechnology Led Enterprises (ABLE) has provided valuable inputs in formulating an industry friendly and futuristic policy document. The policy provides support for development of biotech parks promoted by state agencies or private sectors. Biotech units shall be provided capital investment subsidy on actual investment in plant and machinery. Soft loan assistance will be provided to large & mega biotech units operating in the state for setting up production units in key biotech areas using high end technologies. Eligible biotech startups will be provided with financial assistance for showcasing their products or technologies in national or international events. The government will also constitute an Odisha Biotech Vision Group (OBVG) to act as a think tank and advisory body on diverse policy related issues. ]]> https://biospectrumindia.com/news/22/24109/telangana-drugs-control-administration-raids-unlicensed-clinics-seizes-medicines-worth-lakhs.html https://biospectrumindia.com/news/22/24109/telangana-drugs-control-administration-raids-unlicensed-clinics-seizes-medicines-worth-lakhs.html Wed, 24 Jan 2024 00:00:00 +0530 In a relentless pursuit of enforcing the Drugs and Cosmetic Act regulations 1940 and the Pharmacy Act 1948 and Practice regulations 2015 in Telangana, the Drugs Control Administration (DCA) officials conducted raids on unauthorised clinics in Ranga Reddy and Warangal districts. The crackdown resulted in the confiscation of a substantial cache of medicines and antibiotics, valued in lakhs of rupees, stocked without any proper licenses. On January 23, 2024, acting on credible information, DCA officials from the Serilingampally Zone targeted the premises of a self-proclaimed 'Private Medical Practitioner,' Rahul Kumar Sharma, operating from Anvish Clinic in Narsingi village, Gandipet, Rangareddy District. The raid exposed a staggering array of illegally stocked medicines, including antibiotics, anti-ulcer drugs, painkillers, anti-tussive drugs, and multivitamins. The seized stock was estimated to be worth Rs five lakh.  In a separate operation, DCA officials in Warangal raided the premises of T. Rajender, practicing medicine without qualification at his First-Aid clinic in Khila Warangal village. The unlicensed clinic was found to be stocking and selling medicines without the required drug license. The officials confiscated forty varieties of medicines, including seven labeled as 'Physician Samples,' amounting to a total worth of Rs eighty thousand. The raids revealed the presence of several 'antibiotic medicines' at the clinics, raising concerns about the indiscriminate sale of antibiotics by unqualified individuals. Samples have been collected for analysis, and further investigations will be conducted to take legal action against the offenders. ]]> https://biospectrumindia.com/news/22/24098/govt-to-open-human-resources-development-centre-in-bhubaneswar-for-ayush-professionals.html https://biospectrumindia.com/news/22/24098/govt-to-open-human-resources-development-centre-in-bhubaneswar-for-ayush-professionals.html Sun, 21 Jan 2024 00:00:00 +0530 Union Minister of Ayush and Ports, Shipping & Waterways Sarbananda Sonowal laid the foundation stone for ‘Ayush Diksha’, a first-of-its-kind centre for development of human resources for Ayush professionals of future. This state-of-the-art centre will be developed within the campus of Central Ayurveda Research Institute, Bhubaneswar. "This centre will enable the Ayush professionals to hone up their skills and upscale their dexterity in providing world class patient care services to the people of the country", said the Minister. The institution will offer training programmes for Ayush professionals, especially those from Ayurveda, as it aims to collaborate with national institutes of prominence for capacity development, strengthening human resources, facilitate research and development, achieve self-sustainability with an objective to generate revenue. The Ayush Diksha centre is being built with a budget of Rs 30 crore. It will be equipped with state-of-the-art facilities including two auditoriums, 40 modern rooms with all amenities, suites for VIPs, dedicated space for a natural library, discussion rooms, modular kitchen, dining lounge, among other amenities. ]]> https://biospectrumindia.com/news/22/24087/cabinet-approves-international-mous-on-cooperation-in-field-of-medical-products-regulation.html https://biospectrumindia.com/news/22/24087/cabinet-approves-international-mous-on-cooperation-in-field-of-medical-products-regulation.html Fri, 19 Jan 2024 00:00:00 +0530 Union Cabinet chaired by Prime Minister Narendra Modi was apprised of a Memorandum of Understanding signed between the Central Drugs standard Control Organization (CDSCO), Ministry of Health and Family Welfare, The Republic of India and Directorate General for Medicine, Foods and Sanitary Products Organizations of Ministry of Public Health and Social Assistant of Dominican Republic on cooperation in the field of Medical Products Regulation.   The MoU will promote exchange of information and cooperation in areas pertinent to medical products and relevant administrative and regulatory matters within the jurisdiction of the parties. In order to tackle issues of substandard, falsified medicines moving in the international markets, interaction amongst regulatory agencies is facilitated through signing of MoU. Convergence in the regulatory practices could helping increasing export of medicines from India and consequentially help in better employment opportunities for educated professionals in the Pharmaceutical sector. The Cabinet has also approved a Memorandum of Intent (MoI) signed between the CDSCO and Sport, Kingdom of the Netherlands on behalf of Medicines Evaluation Board, Health and Youth Care Inspectorate, Central Committee on research Involving Human Subjects “on cooperation in the field of Medical products Regulation”. Additionally, MoU between the CDSCO and Agencia Nacional de Regulaction, Control Y Vigilancia Sanitria – ARCSA, Doctor Leopoldo Izquieta Perez, The Republic of Ecuador on cooperation in the field of Medical Products Regulation, has also been approved.   ]]> https://biospectrumindia.com/news/22/24071/icmr-provides-grant-to-establish-centre-for-advanced-research-for-rural-healthcare-transformation.html https://biospectrumindia.com/news/22/24071/icmr-provides-grant-to-establish-centre-for-advanced-research-for-rural-healthcare-transformation.html Tue, 16 Jan 2024 00:00:00 +0530 The Centre for Chronic Disease Control (CCDC) has been awarded the Indian Council of Medical Research (ICMR) grant to establish a Centre for Advanced Research (CAR) for rural healthcare transformation (RAHAT).   Through this grant, CCDC will strive to enhance healthcare inclusivity by enabling primary healthcare accessibility across rural India through the innovative integration of digital health solutions. The CAR for RAHAT, with its Smart Village Initiative, also has the potential to enable social inclusion, empower communities, provide enhanced continuity of care, build research and practice capacity, and establish a robust rural health ecosystem.   The centre will examine implementation gaps in healthcare infrastructure, digital access, and community access and deploy customised interventions to bridge the healthcare inclusivity gap. Through this centre for RAHAT, CCDC aims to create a scalable, multi-stakeholder, transformative rural health research and training platform across four Indian states, to begin with.   This will employ a network of interconnected ICMR health research infrastructure in medical colleges and research institutions across the country. Embracing the objectives of the Ayushman Bharat Digital Mission (ABDM), the ICMR-CAR for RAHAT seeks to promote integration and interoperability, fostering a resilient rural health ecosystem.  ]]> https://biospectrumindia.com/news/22/24063/indian-healthcare-sector-expects-structural-fiscal-reforms-in-budget-2024-25.html https://biospectrumindia.com/news/22/24063/indian-healthcare-sector-expects-structural-fiscal-reforms-in-budget-2024-25.html Fri, 12 Jan 2024 00:00:00 +0530 In a transformative move, the Indian healthcare sector is urging comprehensive structural and fiscal reforms in the upcoming Interim Union Budget 2024-25. Even though it would be an Interim Budget, given the government’s priority to healthcare, it is expected that Finance Minister Nirmala Sitharaman would walk some extra mile concerning further strengthening the sector. Being the backbone of the healthcare industry, hospitals are anticipating significant measures, including the establishment of a dedicated regulator and rationalisation of import duties on medical equipment. The hospital sector, constituting 80% of the total healthcare market, seeks a booster dose through some specific structural and fiscal reforms including a push to Healthcare Insurance, Medical Travel Value,  the establishment of a Regulator, Import Duty Rationalization on Medical Equipment, and Price Rationalisation. Low penetration of Health insurance remains a major pain point. The sector would be expecting the widening of Ayushman Bharat- Pradhan Mantri Jan Arogya Yojna (PMJAY) on the one hand and a reduction of tax on healthcare insurance premiums on the other. "India needs a health insurance model that prioritises preventive healthcare over procedures, and Narayana Health is well placed to achieve this goal with the support of the government”, said Viren Shetty, Executive Vice Chairman of Narayana Health. Sugandh Ahluwalia, Chief Strategy Officer, Indian Spinal Injuries Centre, New Delhi, said, “The hospital sector is in dire need of a dedicated regulator and it is widely admitted that the establishment of a Regulator, leveraging the expertise of organizations like the National Accreditation Board for Hospitals & Healthcare Providers (NABH), can significantly streamline compliance and enhance transparency." “Union Budget should focus on further boosting research and development infrastructure and tax rationalization, gearing up for an aspirational $50 billion MedTech economy,” expounded Prashant Arer, India Head, Enbio Group AG.    Dr Anand Bansal, Medical Director, Sri Balaji Action Medical Institute, said, "Rational pricing is the key. Timely payments and transparent pricing are essential for hospitals to provide quality care. We look forward to clear guidelines from the government, addressing outstanding dues and revising rates under government schemes to ensure the viability of healthcare institutions." Healthcare Expert Baldev Raj, Founder and Chief of Prius Healthcare said, “The government needs more initiatives like ‘Ayush Visa’ (Special Visa Scheme for foreigners) and ‘Heal in India’ to make Indian healthcare and wellness a global phenomenon."  Overall, experts expect that the government will surely take some additional measures to create a new healthcare economy in the country. ]]> https://biospectrumindia.com/news/22/24028/govt-to-open-new-state-branches-of-national-centre-for-disease-control-and-bsl-3-labs.html https://biospectrumindia.com/news/22/24028/govt-to-open-new-state-branches-of-national-centre-for-disease-control-and-bsl-3-labs.html Tue, 02 Jan 2024 00:00:00 +0530 Union Minister of Health and Family Welfare Dr Mansukh Mandaviya laid the foundation stone for National Centre for Disease Control (NCDC) Regional Branch in Assam, State branches in 6 States (Haryana, Tamil Nadu, Karnataka, Odisha, West Bengal and Mizoram) and biosafety lavel or BSL-3 labs in 2 States (Himachal Pradesh and Jharkhand) virtually. He also inaugurated a temporary NCDC Regional branch in Bhopal, Madhya Pradesh. These new NCDC branches and BSL-3 labs will strengthen the country’s capacity for pandemic preparedness and disease surveillance with One Health approach. He also dedicated an Auditorium and Library block as a part of upgraded NCDC, Delhi to the nation and released several technical documents such as Centre for Environmental & Occupational Health, Climate Change and Health, NCDC Booklet; Epidemiology, NCDC technical report; Centre for One Health, NCDC vision document; National Centre for Vector Borne Disease Control – 'National Strategic Plan: Malaria Elimination-2023-27'. State branches of NCDC and BSL-3 laboratory once functional will augment the capacity of region/state for preparedness and response especially for outbreak prone diseases by high-risk pathogens.  Dr Mandaviya informed that a forward-looking strategy has been envisaged for the NCDC's evolution through which it is planned to establish 30 NCDC state branches, 5 NCDC regional branches and 10 BSL-3 laboratories in phase-wise manner for decentralising the presence of NCDC.  ]]> https://biospectrumindia.com/news/22/24026/dca-telangana-cracks-down-on-counterfeit-drug-racket.html https://biospectrumindia.com/news/22/24026/dca-telangana-cracks-down-on-counterfeit-drug-racket.html Sun, 31 Dec 2023 00:00:00 +0530 In a significant operation, the Drug Control Administration (DCA) of Telangana has successfully dismantled a spurious/counterfeit drug manufacturing racket operating in Kukatpally, Hyderabad. The authorities seized counterfeit medicines valued at Rs 6 lakh from an unlicensed entity named Rams Pharmaceuticals located in Moosapet. According to DCA officials, Rams Pharmaceuticals was illicitly producing counterfeit Anti Ulcer medicines in the name of a Punjab-based company without the requisite drug license from state regulatory authorities. Initial investigations revealed that Kouchika Ranjith Kumar, along with Mada Pavan and Shaik Subhani, were engaged in the illegal manufacturing of spurious drugs at Rams Pharmaceuticals, posing as a Food Supplement manufacturer.   The illicit products were then supplied to a wholesale distributor, M/s. Biomedic Pharmaceutical Private Ltd, situated in Nizamabad district. Kamalasan Reddy, Director General of Drugs Control Administration (DCA) Telangana, disclosed that acting on reliable intelligence, a team from DCA's Medchal zone conducted a surprise raid at Rams Pharmaceuticals' premises in Moosapet. The company, holding a Food Manufacturing Licence (FSSAI license), was found to lack any drug manufacturing license. During the raid, DCA officers uncovered the manufacturing of Anti Ulcer medicines, specifically "Essom-RD (Esomeprazole Gastro-Resistant & Domperidone Sustained Release capsules)," based on label foils linking the drug to QP Phermachem Ltd in Punjab. Stereos used for printing batch details on medicine labels were also confiscated. The investigation further revealed that the counterfeit drugs were supplied to M/s. Biomedic Pharmaceuticals Pvt Ltd. in Nizamabad through Jaypee Daily Parcel Services located in Kukatpally. DCA officers in Nizamabad subsequently raided the distributor and seized 29,600 capsules of the spurious drug.   G. Sreenivas, Assistant Director, Medchal, and Drugs Inspectors N. Sahaja and M. Sreebindu conducted the raid at Moosapet, while P. Sarala, Deputy Director, Nizamabad, and Drugs Inspectors N. Narsaiah, V. Srikanth, and R. Srilatha carried out the operation in Nizamabad. DCA officials said that the spurious drugs pose a severe threat to public health, jeopardising patients' well-being. The seized counterfeit medicines have been taken for analysis, and further investigations will be conducted to take legal action against all involved offenders. The DCA remains committed to safeguarding public health and ensuring the integrity of the pharmaceutical supply chain, as observed by the drug regulatory authorities.  ]]> https://biospectrumindia.com/news/22/24001/gujarat-becomes-first-indian-state-to-launch-fdca-mdmla-app-for-online-medicine-licensing.html https://biospectrumindia.com/news/22/24001/gujarat-becomes-first-indian-state-to-launch-fdca-mdmla-app-for-online-medicine-licensing.html Tue, 26 Dec 2023 00:00:00 +0530 In a pioneering move towards efficient governance, Gujarat has achieved a remarkable milestone by becoming the first state in the country to introduce online licenses for allopathic medicines through the newly launched FDCA-mDMLA mobile app. Unveiled on Good Governance Day, December 25, 2023, by Bhupendra Patel, Chief Minister of Gujarat, this mobile application promises to streamline and expedite the licensing process for pharmaceuticals. The FDCA-mDMLA app, a leap in m-governance, consolidates various online platforms into a single interface, providing stakeholders with real-time access to the status of their applications. This initiative extends its benefits to Ayurvedic medicine and cosmetic manufacturers and sellers, aligning with the state's commitment to e-governance. Overseen by a senior FDA official of Assistant Commissioner rank, this mobile governance system marks a significant step in the direction of ease of doing business. According to Gujarat Food and Drug Control Administration (FDCA) Commissioner Dr HG Koshia, “The app encompasses 24 categories, facilitating online Extended Licensing Node (XLN), online drug manufacturing license application (DMLA), iDMLA, COSMLA, AYUMLA, and CERTIFICATE functions.” Dr Koshia emphasised, "Around 6000 manufacturers and more than 52000 drug sellers in the state will benefit directly from this mobile app, providing anytime, anywhere access to their operations, services, and information." This groundbreaking mobile app assures transparency and accountability in the licensing process. It allows users to obtain digitally signed licenses, certificates, and approvals through their mobile devices, providing real-time updates on the status of their applications. Furthermore, the app encompasses all services under the Right of Citizens to Public Service (RCPS) Act. Gujarat FDCA's transition from e-governance to m-governance is expected to create a unified platform for all licensees, ensuring easy access to regulatory information, licensing rules, procedures, protocols, and processes. The move represents a departure from traditional offline operations, where applicants had to physically visit the office for application submissions and follow-ups. The journey toward digitisation began in 2011 with the development of the Gujarat FDCA online platform DMLA software, streamlining the paperless delivery of services for granting product licenses. In 2007, Gujarat also pioneered the online XLN system for the online grant of retail/wholesale sales licenses. The Chief Minister’s earlier launch of the cosmetic manufacturing license portal in 2022 was another step towards transparency and efficiency in the licensing process. “Gujarat's commitment to technological advancements in governance reaffirms its position as a leader in pioneering initiatives that prioritise transparency, efficiency, and inclusivity. The FDCA-mDMLA app sets the stage for a new era in regulatory processes, promising a seamless experience for all stakeholders in the pharmaceutical and healthcare industry,” Dr Koshia concluded.    Bhagwati Prasad ]]> https://biospectrumindia.com/news/22/24002/govt-makes-rs-53-cr-investment-to-increase-rd-of-ayurveda-and-folk-medicine-in-arunachal-pradesh.html https://biospectrumindia.com/news/22/24002/govt-makes-rs-53-cr-investment-to-increase-rd-of-ayurveda-and-folk-medicine-in-arunachal-pradesh.html Tue, 26 Dec 2023 00:00:00 +0530 Union Minister of Ports, Shipping & Waterways and Ayush, Sarbananda Sonowal and the Chief Minister of Arunachal Pradesh, Pema Khandu laid the foundation stones for capacity expansion at the North Eastern Institute of Ayurveda and Folk Medicine Research (NEIAFMR) at Pasighat, Arunachal Pradesh. With a total investment of Rs 53 crore, additional infrastructure will be developed at the institute. The institute has also been working towards scientifically document, record, research as well as validate the folk medicine of the Northeast. The capacity expansion at the institute include an academic building, hostels for boys and girls students, staff quarters as well as director’s bungalow. The hostels will accommodate 70 boys and 70 girls students from the institute. The investment will cater to development of additional infrastructure for opening of Ayurveda college for imparting quality in undergraduate course in Ayurveda, Bachelor of Ayurveda Medicine and Surgery (BAMS) as well as Post Graduate courses in due course of time. The new Ayurveda college at NEIAFMR, Pasighat will promote and develop Ayurveda through Education, Research and Extension Services. The Engineering Projects (India) Limited, a Government of India enterprise, is the executing agency for the project. ]]> https://biospectrumindia.com/news/22/23993/stringent-testing-protocols-in-place-for-export-of-indian-cough-syrup-samples.html https://biospectrumindia.com/news/22/23993/stringent-testing-protocols-in-place-for-export-of-indian-cough-syrup-samples.html Fri, 22 Dec 2023 00:00:00 +0530 In a proactive measure to ensure the safety and efficacy of Indian cough syrup meant for export, 445 batches of cough syrup samples from various manufacturers across India have been dispatched to multiple laboratories nationwide for rigorous testing. The Central Drugs Standard Control Organization (CDSCO) disclosed that, as of December 20, 2023, drug testing laboratories in India have received a total of 445 batches of cough syrup samples. These samples will undergo thorough testing, scrutinizing parameters such as toxicity, efficacy, and safety. Only after clearing these stringent tests and obtaining safety certification will the respective manufacturing companies be authorized to export their cough syrup globally. The decision to intensify testing procedures comes in the wake of a recent incident in Gambia, Africa, where infants experienced adverse effects, leading to fatalities after the administration of Indian cough syrup. This unfortunate incident drew global attention, prompting concerns about the reputation of the Indian pharmaceutical industry. The World Health Organization even issued alerts and blacklisted certain pharmaceutical companies. In response to these challenges, the CDSCO has amended its standard regulations. It is now mandatory for all cough syrup manufacturing companies to submit samples of each batch for testing before exporting to global markets. As part of this initiative, 83 batches from Maharashtra are being tested at the Central Drug Testing Laboratory (CDTL) in Mumbai, 12 batches at CDTL Hyderabad, 57 batches at the Regional Drug Testing Lab in Chandigarh, and 132 batches at IPC Ghaziabad. Additionally, 67 batches have been sent to various state laboratories, including Food and Drug Lab Gujarat, Jammu, Kerala, and Bhopal. The remaining 97 batches are undergoing testing at private drug testing facilities. Only after receiving clearance from these laboratories will the concerned manufacturers obtain approval for exporting the cough syrup to the global market, ensuring a heightened level of scrutiny and safety in the pharmaceutical export process.   Amguth Raju ]]> https://biospectrumindia.com/news/22/23964/centre-readies-to-regulate-medical-device-alongside-drugs-industry-expresses-dismay.html https://biospectrumindia.com/news/22/23964/centre-readies-to-regulate-medical-device-alongside-drugs-industry-expresses-dismay.html Sat, 16 Dec 2023 00:00:00 +0530 Consumer Patient groups, Healthcare Providers have joined manufacturers associations in expressing profound dismay as the Centre reportedly prepares to table the New Drugs, Cosmetics & Medical Device Bill, 2023 in Parliament without adequately addressing their concerns. The proposed legislation, aimed at regulating the medical device sector, had earlier garnered widespread apprehension from industry stakeholders who feel that their input has been overlooked. Despite recent consultations, industry leaders argue that key issues such as regulatory complexities, the potential impact on innovation, and the need for a conducive business environment have yet to be adequately assured by redressal in the bill. The lack of alignment with industry expectations has raised fears of stifling growth and hindering technological advancements in the medical device sector and continued import dependence as it is easier to import high end medical devices than to get regulatory approval for domestic manufacturers. As the Bill is reported to move forward, there is a palpable sense of frustration among industry leaders who were hopeful for a more collaborative and responsive approach from the government. Association of Indian Medical Device Industry (AIMED) Forum Coordinator Rajiv Nath, while expressing his disappointment, said, "NITI Aayog had drafted an excellent Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 but in vain and we keep going in circles. Who gains from putting Indian manufacturers at a disadvantage over imports and by Drug pharmacists weighed biased regulatory controls? Even the impactful recent progressive legislations in countries like Canada, UK, EU, Brazil, Malaysia, Singapore and Saudi Arabia were not studied. Who blocked that progressive visionary Bill?”    Discussing the potential impact of the Bill, which appears to favour foreign players, Dr Giridhar Gyani, Direcor General of the Association of Healthcare Providers India (AHPI), said, "In the national interest, it is crucial for us to highlight that if the Bill is passed as is, the healthcare providers sector, heavily reliant on medical devices and advocating for increased availability of affordable, high-quality, made-in-India medical devices, may once again face challenges in management of supply chain, leading to crisis and country wide lockdown similar to the onset of Covid. Domestic manufacturers might lose their capacity to swiftly address domestic demand, especially in the event of a pandemic” K L Sharma, former Joint Secretary in the Ministry of Health & Family Welfare, GoI (2014-17), who coordinated the creation of Medical Devices Rules, 2017 stated, "Treating medical devices at par with drugs for regulatory purposes is fraught with danger for various reasons including the fact that such an arrangement puts unnecessary burden on medical device manufacturers in terms of compliances and leaves out more vital aspects that are crucial for ensuring the safety and effectiveness of medical devices."     Gaurav Agarwal, Managing Director, Innvolution Healthcare that produces cardiac imaging equipment said “If food can have FSSAI we need a separate regulatory framework too if we aspire to be global leaders. “   Interestingly the Parliamentarians in the Health Committee had initially responded specifically that instead of drafting a combined legislation for Drugs, Medical Devices and Cosmetics, the Ministry should formulate a separate legislation for Medical Devices. The Committee had reiterated its earlier recommendations that the new legislation should set up a new set of regulators at different levels for regulating the Medical Devices industry. Unlike the present structure, the proposed National regulator should license the manufacturing of medical devices like FSSAI, and the state regulators be supervised by the National Regulatory Authority to help harmonise the regulatory process throughout the country. ]]> https://biospectrumindia.com/news/22/23960/new-guidelines-for-haemophilia-treatment-to-empower-policymakers-in-india.html https://biospectrumindia.com/news/22/23960/new-guidelines-for-haemophilia-treatment-to-empower-policymakers-in-india.html Fri, 15 Dec 2023 00:00:00 +0530 The Haemophilia & Health Collective of North (HHCN), a registered body of India’s leading healthcare professionals working in the domain of haemophilia care for over two decades, in collaboration with National Health Mission (NHM) representatives from 16 states, has proposed a first-of-its-kind Indian guidelines for treatment of Persons with Haemophilia (PwH).  The new guidelines recommend use of prophylaxis as standard of care (SOC) in haemophilia patients to prevent them from bleeding, and clearly articulates the need for comprehensive care including significance of timely diagnosis, physiotherapy and multidisciplinary care for PwH. First time a separate category for Non-factor replacement (currently available as Emicizumab) is incorporated in the selection criteria. The real world experience bears out the rapid switchovers to non-factor products and which remains the drug of choice. The new guidelines also recommend budgetary calculation for payers and/or policymakers to understand the budgetary requirements of each state and central reimbursement bodies. Optimal deployment of resources for severe Hemophilia A patients including high bleeders, pediatric population, patients with inhibitors is also suggested. Current treatment modalities in India primarily focus on on-demand therapy – FVIII replacement to address bleeding episodes as they occur. However, exposure to exogenous Factor VIII could lead to development of inhibitors. This renders treatment with Factor VIII ineffective.  The new guidelines recommend adoption of advanced care to tackle bleeding incidents and reduce disability and improve quality of life for haemophilia patients. Worldwide, countries are moving towards advanced non-replacement therapy or prophylaxis care because breakthrough bleeds remain an issue with the levels of protection offered by current FVIII concentrates. In India, prophylaxis adoption is estimated at about 4%, whereas in most other developing countries it is over 20% and in developed countries 80-90% haemophilia patients are on prophylaxis.   ]]> https://biospectrumindia.com/news/22/23946/policy-consultation-to-discuss-opportunities-to-strengthen-cervical-cancer-screening-in-india.html https://biospectrumindia.com/news/22/23946/policy-consultation-to-discuss-opportunities-to-strengthen-cervical-cancer-screening-in-india.html Tue, 12 Dec 2023 00:00:00 +0530 A policy consultation on cervical cancer screening and treatment was recently held in New Delhi that demonstrated the collective resolve amongst key stakeholders to accelerate the elimination of cervical cancer in India. The consultation was organised by FIND, a non-profit organization focused on improving equitable access to diagnosis. It was attended by Members of Parliament Dr Fauzia Khan and Vandana Chavan, who highlighted the importance of prioritising women’s health and suggested a roundtable with Parliamentarians to discuss strategies to eliminate cervical cancer. During the consultation, the Government of India’s commitment to eliminate cervical cancer was underscored by Professor S.P. Singh Baghel, Minister of State for Health and Family Welfare, Government of India, who delivered a video message calling upon stakeholders to adopt a multi-sectoral approach to bring cervical cancer diagnosis to the doorstep of the community. During the discussions, the introduction of high-performance human papillomavirus (HPV) DNA tests recommended by the World Health Organization (WHO), complemented by approaches such as self-sample collection to ensure effective screening, and strengthening inter-ministerial collaboration, were emphasised as critical components of a robust cervical cancer elimination strategy. Dr Sanjay Sarin, Vice President Access, FIND, said, “FIND aims to increase access to HPV screening and supporting countries with meeting the WHO cervical cancer elimination goals." The consultation was supported by Roche Diagnostics. Michelle Medeiros, Head of Access and Policy, Roche Diagnostics Asia Pacific, said, "Collaborative multi-stakeholder partnerships and system-wide approaches can tackle some of the biggest obstacles faced in improving inequities in cervical cancer care. This includes establishing a nationwide momentum towards programmes, funding and infrastructure for immunisation, early screening, diagnosis, and treatment in cervical cancer.” ]]> https://biospectrumindia.com/news/22/23918/telangana-dca-seizes-rs-4-05-cr-worth-of-spurious-anti-cancer-drugs.html https://biospectrumindia.com/news/22/23918/telangana-dca-seizes-rs-4-05-cr-worth-of-spurious-anti-cancer-drugs.html Tue, 05 Dec 2023 00:00:00 +0530 In a significant operation, the Drug Control Administration (DCA) authorities of Telangana have unearthed an illicit stockpile of counterfeit anti-cancer drugs valued at Rs 4.05 crore. The crackdown on this criminal enterprise, involving an unlicensed firm named "Astrica Healthcare," led to a series of raids across multiple locations in Hyderabad city. The Assistant Director of DCA Telangana, P. Ramu, disclosed that the operation was initiated based on credible information received by the Vigilance Cell of the Drugs Control Administration. The special team, comprising Drugs Inspectors G. Srikanth, K. Anvesh, M. Chandrasekhar, V. Ajay, and S. Vinay Sushmi, conducted raids on December 2, 2023. Upon discovering that the address provided by "Astrica Healthcare" was fictitious, the DCA officials collaborated with postal authorities at Alwal to trace the culprits. Subsequently, raids were conducted at courier offices in IDA Cherlapally, Nacharam, and Medchal, as well as at the premises of 'Astrica Healthcare' in Keesara. The vigilant DCA team identified the courier boy responsible for delivering the spurious drugs and tracked down their storage location at Macha Bollaram—an unlicensed facility. Monitoring the premises since December 2, 2023, the DCA officials, including Assistant Directors P. Ramu and V. Balanaganjan, raided the location on December 4, 2023, seizing 36 varieties of anti-cancer drugs and other medications valued at Rs. 4.05 crore. The investigation revealed that certain seized drugs bore labels with details of a non-existent company, 'Astra Generics Pvt. Ltd.,' whose licenses were canceled in July 2021. The manufacturing date on the spurious drugs was noted as March 2023, under the name of the said canceled company. The spurious drugs were falsely labeled under various legitimate companies, including Astra Generics Pvt. Ltd., Astrica Healthcare Pvt. Ltd., Medion Biotech Pvt. Ltd., Alliance Biotech, Sunvet Healthcare, Salus Pharmaceuticals, DM Pharma Pvt. Ltd., Safe Parenterals Pvt. Ltd., and Bless Pharma India Pvt. Ltd. Director General of Drugs Control Administration of Telangana, V.B. Kamalasan Reddy, emphasised the grave threat posed by spurious drugs to public health, as they not only fail to treat diseases but can also lead to catastrophic consequences. This seizure, marking the largest in the state, underscores the DCA's commitment to safeguarding public health. Efforts are underway to locate and apprehend the prime accused, K. Sateesh Reddy, Director of Astrica Healthcare, who is currently absconding.   ]]> https://biospectrumindia.com/news/22/23924/govt-puts-forward-bio-vision-for-bharat-at-bric-societys-maiden-meeting.html https://biospectrumindia.com/news/22/23924/govt-puts-forward-bio-vision-for-bharat-at-bric-societys-maiden-meeting.html Tue, 05 Dec 2023 00:00:00 +0530 In a groundbreaking session marking the inaugural gathering of the BRIC Society, Union Minister of Science and Technology Dr Jitendra Singh emphasised the need to define "Bio-Vision" for Bharat. This significant move comes after the recent registration of the Biotechnology Research and Innovation Council (BRIC) following Cabinet approval on November 10, 2023. Highlighting India's bio-economy growth, Dr Singh noted a thirteen-fold increase in the last decade. Quoting Prime Minister Modi's aspiration for India to enter the top-10 countries in the global biotech ecosystem, Dr Singh sees BRIC as a testament to achieving this goal by uniting brilliant minds on a single platform through the spirit of Sabka Prayas. The Department of Biotechnology (DBT), Ministry of Science and Technology, has received Cabinet approval to streamline its 14 Autonomous Institutions (AIs) under BRIC for centralised governance, maximising biotech research impact nationwide. Seeking input from accomplished institution-builders, the Minister urged the BRIC meeting to define the "Bio-Vision" for Bharat. BRIC will maintain distinct research mandates for its 14 subsumed institutions, governed by a unified Governing Body.  To enhance scientific capabilities, BRIC will introduce new PhD programmes, common course curricula, and additional scientific positions. The BRIC Society will oversee 14 renowned institutions, including the National Institute of Immunology, National Brain Research Centre, and Center of Innovative and Applied Bioprocessing.   ]]> https://biospectrumindia.com/news/22/23928/iit-guwahati-tata-medical-diagnostics-nhm-assam-partner-to-revolutionise-healthcare-delivery.html https://biospectrumindia.com/news/22/23928/iit-guwahati-tata-medical-diagnostics-nhm-assam-partner-to-revolutionise-healthcare-delivery.html Tue, 05 Dec 2023 00:00:00 +0530 The Indian Institute of Technology Guwahati (IIT-G) has joined hands with Tata Medical & Diagnostics (Tata MD) and National Health Mission, Assam, Health & Family Welfare Department, Govt. of Assam, to sign a Memorandum of Understanding (MoU) to implement the Tata MD’s Healthcare Model for augmenting public healthcare delivery in the Kamrup district of Assam by establishing a Digital Nerve Centre. The MoU was signed by Dr M.S. Lakshmi Priya, IAS, MD, NHM Assam, Girish Krishnamurthy, MD & CEO, TATA MD, and Prof. Parameswar K. Iyer, Dean PRBR, IIT Guwahati. One major highlight of this project will be Bill & Melinda Gates Foundation’s involvement as the strategic partner to provide inputs and share learnings of adapting and implementing innovative models, as well as taking the learnings from the initiative to other states and globally to ensure more women and children have access to lifesaving care. To implement this project, a Digital Nerve Centre – Command Centre (Hub) will be established at IIT Guwahati campus with technical, IT and physical infrastructure setup, and vendor coordination support from Tata MD. Another major initiative of this pilot project will be to setup Digital Nerve Centre (DiNC) components at Healthcare Centres in 30 District Hospital (DH), Community Health Centres (CHC), Primary Health Centres (PHC), and Sub-centre (SC) in Assam. With the Digital Nerve Centre – Command Centre (hub) established at IIT Guwahati, NHM will be able to deploy systems and technologies to implement the Healthcare Model for augmenting public healthcare delivery.   The Tata MD’s Healthcare Model for augmenting public healthcare delivery is a first-of-its-kind model in the North Guwahati block that will focus on enhancing government programmes, providing continuous, connected, proactive, patient-centric, and closer-to-patient care services.  ]]> https://biospectrumindia.com/news/22/23893/karnataka-government-unveils-draft-of-biotechnology-policy-4-0.html https://biospectrumindia.com/news/22/23893/karnataka-government-unveils-draft-of-biotechnology-policy-4-0.html Thu, 30 Nov 2023 00:00:00 +0530 At the inauguration of the 26th edition of Bengaluru Tech Summit on 29 November 2023, Priyank Kharge, Minister for Information Technology, Biotechnology, Government of Karnataka, along with other dignitaries, unveiled the draft of Biotechnology policy 4.0, based on inputs gathered by the Association of Biotechnology Led Enterprises (ABLE) from many industry and academic experts in the State. The new draft Karnataka Policy intends to support the concept of High-Tech Biotech Clusters (5 – 10 acres) wherein the developed industry would be encouraged to set-up their manufacturing units and support startups and SMEs with plug and play facilities. There are plans to set-up a green-field Bio Foundry in public-private partnership (PPP) mode. The bio-foundry facility will address the growing demands of the growth-stage companies and to meet their requirements of GMP Pilot Plant & scale-up facility. Provision of Biomanufacturing Unit Investment Subsidy of maximum Rs 10 crore, Reimbursement of up to 50% expenses incurred for procuring high end equipment’s for undertaking cutting edge R & D (upto Rs 10 lakh), reimbursement of Lease Rental for Startups and MSMEs (upto Rs 5 lakh), Employment Generation Incentive upto Rs.50,000 per fresher employed, and reimbursement of Internship Stipend upto Rs 5000 per Internee have been newly proposed. Efforts will be now made with the support of IT BT Department, Government of Karnataka to get feedback and further inputs on the draft policy and come out soon with the futuristic Biotechnology Policy 4.0 for Karnataka.   Feedback and inputs can be sent to karbtpolicyinputs@gmail.com       ]]> https://biospectrumindia.com/news/22/23854/who-ministry-of-ayush-ink-traditional-and-complementary-medicine-project-collaboration-agreement.html https://biospectrumindia.com/news/22/23854/who-ministry-of-ayush-ink-traditional-and-complementary-medicine-project-collaboration-agreement.html Mon, 20 Nov 2023 00:00:00 +0530 The Ministry of Ayush and World Health Organization (WHO) have signed Traditional and Complementary Medicine 'Project Collaboration Agreement' late last week in Geneva.  Indra Mani Pandey, Permanent Representative of India to the United Nations, on behalf of the Ministry of Ayush, and Dr Bruce Aylward, Assistant Director General, Universal Health Coverage and Life Course Division, on behalf of WHO, signed the agreement. The main objective of this agreement is to standardise Traditional and Complementary Medical Systems, integrate their quality and safety aspects into the National Health System, and disseminate them at the international level. Through this cooperation agreement, efforts will be made to connect Traditional and Complementary Medical Systems with the mainstream of the National Health System. To fulfil this objective, Traditional Medicine Global Strategy 2025-34 will be prepared by WHO with the support of the Ministry of Ayush. Other major objectives of the agreement include efforts to strengthen the system of training and practice in the field of Complementary Medicine System 'Siddha', formulation of guidelines for the listing of Traditional and Complementary Medicines, safety and related efforts, etc. An International Herbal Pharmacopoeia of herbs found in South-East Asia will be developed by the Ministry in collaboration with WHO. Efforts will be made under this agreement to integrate evidence-based Traditional and Complementary Medicines with the National Health System, conservation and management of biodiversity and medicinal plants, etc. ]]> https://biospectrumindia.com/news/22/23833/karnataka-aims-to-attract-rs-40000-cr-investment-in-khir-city.html https://biospectrumindia.com/news/22/23833/karnataka-aims-to-attract-rs-40000-cr-investment-in-khir-city.html Sun, 12 Nov 2023 00:00:00 +0530 The Karnataka government deliberated on conceptualisation of the development of Knowledge, Healthcare, Innovation and Research (KHIR) City on the outskirts of Bengaluru. The government aims to attract Rs 40,000 crore investment in the areas of healthcare, innovation and knowledge sectors besides creating 80,000 jobs in the proposed KHIR City. The new investment region will be spread over 2,000 acres within 60 kms from Bengaluru and developed in a phased manner. Addressing the Ideation Session for setting up KHIR City, M B Patil, honourable minister for large and medium industries and infrastructure development said, "We are embarking on a transformative journey to build a city that goes beyond conventional boundaries — a Knowledge, Healthcare, Innovation & Research City (KHIR City).” "Apart from ensuring job creation and attracting investments from leading global and Indian hospitals and research centres, universities and private companies, the initiative has the potential to contribute towards the state’s Gross Domestic Product (GDP) due to increased economic activity. “Besides attracting investments, it is aimed at contributing at least Rs 1 lakh crore to the state GDP,” Patil said. The captains of Indian industry drawn from healthcare, medical education, real estate, financial services and insurance sectors attended the ideation session and shared their suggestions.  With Karnataka being home to 60 per cent of India’s biotech companies and over 350 medical devices and supplies manufacturers across categories, the development of KHIR near Bengaluru, the fastest-growing innovation cluster globally, augurs as an ideal location.  Speaking on the occasion, Priyank Kharge, Minister for IT/BT, and S&T said that KHIR City will be the first such centre of knowledge which will have innovators from healthcare, knowledge and global research centres coming together in one place. “Bengaluru will transform from being a call centre of the world to global centre of research and innovation,” he said. The government is planning to come out with a separate policy to promote the medical tourism in the state, said Kharge. The establishment of KHIR City has a strong global reference point with the Government of Karnataka aiming to bring this research city in line with Singapore’s Biopolis Cluster or Japan’s Kobe Biomedical Innovation Cluster. "There is a need to build neurology institute and genetics here as it is expensive to send it to other states and countries," said Dr C N Manjunath, Director of Jayadeva Institute of Cardiac Sciences. The industry representatives also suggested to the government to look at improving the skills of workers in the state that will be required for the setting up of knowledge city. They also suggested to focus on life sciences and look at holding a roadshow to attract capital into this sector.  “There is shortage of 50-70 million healthcare workers in the country. A Paramedical university is the urgent need. We want to set that up in the country because it is the nurses and other staff that takes care of the patient and not the doctors,” said Dr Devi Prasad Shetty, Founder and Chairman of Narayana Health.     ]]> https://biospectrumindia.com/news/22/23826/uttarakhand-luring-major-focus-sectors-of-ayush-and-pharma-through-industry-friendly-policies.html https://biospectrumindia.com/news/22/23826/uttarakhand-luring-major-focus-sectors-of-ayush-and-pharma-through-industry-friendly-policies.html Thu, 09 Nov 2023 00:00:00 +0530 Speaking on the side-lines of the Mumbai Road Show of the Uttarakhand Global Investors Summit (UKGIS) -2023 in Mumbai on November 6, 2023, Pushkar Singh Dhami, Chief Minister (CM), Uttarakhand observed, "Amongst the top pharma manufacturing states in India, Uttarakhand is poised to become a preferred destination in focus sectors of Ayush, Wellness and Pharma through industry friendly policies and single window system".  The Government of Uttarakhand is organising the two day UKGIS -2023 on December 8 2023 in Dehradun to achieve the ambitious Sashakt Uttarakhand@25 project. The CM added that Uttarakhand is pursuing Prime Minister Narendra Modi's goal of a self-reliant India. The government has set a target of becoming a $5 trillion economy by 2025.  The summit is a joint endeavour of Government of Uttarakhand and the Confederation of Indian Industry (CII) to bring together leading investors from all over the world, senior government officials and local business communities for interactions on the investment environment and opportunities in Uttarakhand. UKGIS-2023 will host strategic conferences, panel discussions, round-table deliberations, presentations, and roadshows in various parts of India and abroad, along with one-to-one business meetings. To apprise the industry about the investment climate in Uttarakhand, the collaborative opportunities present and the UKGIS -2023 Summit, a delegation of government leaders led by the Chief Minister of Uttarakhand along with senior bureaucrats, visited Mumbai on November 6, 2023. CM Dhami informed that Rs one lakh crore worth of MoUs have already been signed which signals a new investment ecosystem currently having evolved and developed in the state. Around 27 policies have been framed in 4 months-time to give the much-needed boost to the investors based in a consultative manner with all the industry stakeholders. Investors making an investment of more than Rs 5 crore will mandatorily get the State Government support and incentives. Also, an international airport at Pantnagar which is likely to come up soon, will further boost trade and investments. Uttarakhand has the distinction of double digit growth in employment rate in the last two decades, 2.5 hours connectivity to Delhi-National Capital Region (NCR), diverse and rich natural resources, 70 per cent working age population, achiever in ease of doing business (EoDB), top performing 6 industrial parks of the State and is amongst top two pharma manufacturing States in India.   ]]> https://biospectrumindia.com/news/22/23822/india-and-netherlands-to-cooperate-on-medical-product-regulation.html https://biospectrumindia.com/news/22/23822/india-and-netherlands-to-cooperate-on-medical-product-regulation.html Wed, 08 Nov 2023 00:00:00 +0530 India and Netherlands have signed a Memorandum of Intent (MoI) to cooperate on medical product regulation and enhance the quality of medical products and healthcare services for both countries at Hague, Netherlands. The MoI was signed during a meeting of Bhagwant Khuba, Union Minister of State for Chemicals and Fertilizers with Ernst Kuipers Minister of Health, Welfare and Sports of the Kingdom of Netherlands. An Indian delegation led by Khuba is in Netherlands to participate in the second World Local Production Forum (WLPF) meeting being held in The Hague from 6 to 8 November 2023. The World Local Production Platform is a platform created at the initiative of the World Health Organisation (WHO) with the aim of increasing access to medicines and other health technologies. The Minister also visited the European Medicines Agency (EMA). He met Carla van Rooijen, Director of the Pharmaceuticals and Medical Technology Division and had a fruitful discussion with her about regulations in the pharmaceutical and medical technology industries. ]]> https://biospectrumindia.com/news/22/23800/us-fda-collaborates-with-telangana-drug-control-administration.html https://biospectrumindia.com/news/22/23800/us-fda-collaborates-with-telangana-drug-control-administration.html Fri, 03 Nov 2023 00:00:00 +0530 In a significant development in the realm of pharmaceutical regulation, officials from the United States Food and Drug Administration (US FDA) recently paid a visit to the Drug Control Administration (DCA) of Telangana, located in Vengal Rao Nagar, Hyderabad. The meeting revolved around discussions on various initiatives aimed at ensuring the stringent implementation of regulatory standards to safeguard the quality and safety of drugs and medicines produced by the pharmaceutical, biotech, and related industries. Among the US FDA delegation were notable figures such as Dr Sarah McMullen, Country Director of US FDA's Indian Office; Dr Phil Nguyen, an International Relations Specialist, and Dr Sudheendra Kulkarni, a Senior Technical Advisor. The Director General of Telangana DCA, V.B. Kamalasan Reddy, extended a warm welcome to the US FDA regulatory authorities and outlined the recent regulatory measures undertaken by Telangana DCA. During the discussions, Director General Kamalasan Reddy shed light on the adoption of risk-based sampling techniques and the issuance of advisories to the industry regarding the testing of raw materials, specifically Glycerin and Propylene Glycol, to monitor DEG and EG content. He also provided a comprehensive overview of the vigilance cell's operations, emphasizing the department's commitment to ensuring the quality of raw materials used by pharmaceutical companies in drug production. Kamalasan Reddy expressed his satisfaction with the visit, noting that the DCA's efforts were well-received by the US FDA officials. He disclosed that the US FDA authorities proposed the establishment of a 'US FDA and Telangana DCA Regulatory Forum' to foster future strategic collaboration and initiatives. The primary objective of this proposed regulatory forum would be to explore elements of observed inspections, with the intent to involve DCA Telangana inspectors as observers in US FDA-led inspections. This collaborative endeavor underscores the commitment of both US FDA and Telangana DCA to strengthen the regulatory framework, ensuring the quality and safety of pharmaceutical products in Telangana and beyond. It marks a significant step towards the shared goal of safeguarding public health and bolstering the pharmaceutical industry's integrity. ]]> https://biospectrumindia.com/news/22/23766/government-approves-51-pharma-companies-for-bulk-drug-manufacturing-incentives.html https://biospectrumindia.com/news/22/23766/government-approves-51-pharma-companies-for-bulk-drug-manufacturing-incentives.html Sun, 29 Oct 2023 00:00:00 +0530 The Indian government has given the green light to 51 pharmaceutical companies to participate in the Production Linked Incentive (PLI) Scheme. This scheme is a pivotal step in promoting and strengthening the bulk drug manufacturing sector in India, and its approval marks a significant milestone in the country's efforts to reduce its dependence on imported pharmaceutical ingredients. Uma Magesh, Under Secretary to the Government of India in the Department of Pharmaceuticals, made this announcement, emphasising the government's commitment to boosting the Indian pharmaceutical industry. India has long relied on China for sourcing Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs). In a bid to reduce this dependency on China and enhance its domestic manufacturing capabilities, India initiated policy changes in 2015. Since then, the central government has taken various initiatives, including the establishment of bulk drug clusters and the introduction of schemes to incentivize both new entrants and existing units to increase their manufacturing capacities. The most recent initiative, the PLI scheme, was launched in 2020 with an initial annual budget of Rs 6940 crores. In a progressive move, the government has decided to extend financial incentives to eligible manufacturers for 41 identified products, encompassing 53 APIs, over a period of six years. The Department of Pharmaceuticals communicated the list of 51 pharmaceutical companies that have been approved under the PLI scheme to the Bulk Drugs Manufacturing Association of India (BDMA). These companies are set to produce a combined total of 92,130 Metric Tons (MT) of various active pharmaceutical ingredients and KSMs. Notable among these companies are Aurobindo Pharma Limited, partnering with Lyfius Pharma to manufacture 15,000 MT of Penicillin G, Karnataka Antibiotics and Orchid Biopharma Limited, each allocated 1,000 MT capacity for C-ACA production. Kinvan Private Limited is permitted to produce 300 MT of Clavulanic Acid, while Hindus Labs, Emmennar Pharma, and Alkimia Pharma-Chem will manufacture a combined total of 6,000 MT of 1,1 Cyclohexane Diacetic Acid (CDA). Meghmani LLP and Sadhana Nitrochem will produce 13,500 MT and 36,000 MT of Para Amino Phenol, respectively. Additionally, Granules India, RMC Performance Chemicals, and Alta Laboratories will contribute 8,000 MT, 1,500 MT, and 2,250 MT of Dicynadiamide (DCDA) to the initiative. The BDMA has expressed its satisfaction at the approval of incentives under the PLI scheme for domestic bulk drug manufacturing companies. Eeshwar Reddy, the Executive Director of BDMA, views this as a positive signal from the government to strengthen the domestic bulk drug industry. With sustained support, India is poised to increase its manufacturing capacity and become a competitive force in the production of affordable APIs for global markets, potentially reducing its reliance on imports. This move is not only a significant step toward self-sufficiency but also a boost to the "Make in India" campaign, aligning with the government's vision of transforming India into a global pharmaceutical manufacturing hub.   Amguth Raju ]]> https://biospectrumindia.com/news/22/23736/telangana-drugs-control-administration-faces-resource-challenges-in-regulating-pharma-biotech-industry.html https://biospectrumindia.com/news/22/23736/telangana-drugs-control-administration-faces-resource-challenges-in-regulating-pharma-biotech-industry.html Sat, 21 Oct 2023 00:00:00 +0530 The Telangana Drugs Control Administration (TSDCA) is waging a relentless battle against resource constraints while endeavoring to enforce the Drugs and Cosmetics Act and Pharmacy Act, ensuring that the pharmaceutical and biotechnology industry in the state complies with safety and quality control regulations. TSDCA operates with a lean team of only 53 officers overseeing a multitude of responsibilities, leaving them grappling with the challenge of meeting inspection deadlines. Their duties encompass the sampling of pharmaceutical products, dispatching them to laboratories for rigorous efficacy and quality assessments, conducting routine inspections, and supervising the adherence to cGMP standards. These tasks extend to monitoring more than 500 pharmaceutical and biotechnology companies, over 35,000 pharmacies, and hundreds of blood banks and hospitals throughout the state, creating a demanding workload for the already stretched resources. Kamalasan Reddy, IPS, Director General of Drug Control Administration, Telangana, revealed that in his three months since taking office as the full-fledged DG, he has been actively engaging with various stakeholders, including the Bulk Drug Manufacturing Association (BDMA), pharmaceutical and biotechnology industry associations, pharmacy associations, blood bank associations, and other healthcare industry stakeholders. The objective is to identify the challenges and issues within the sector and develop solutions to address them. TSDCA shoulders two significant responsibilities: promoting the growth of the pharmaceutical and biotechnology industry by facilitating their establishment in the state, and strictly enforcing the Drugs and Cosmetics Act and Pharmacy Act to ensure that every player in the healthcare and medical technology industry adheres to safety and quality control standards during production. Despite the staffing crunch with 18 vacancies of drug inspectors yet to be appointed by the state government, TSDCA is making the most of its existing workforce by forming teams and outsourcing additional personnel when necessary to ensure strict implementation of the Drugs and Cosmetics Act. In response to anticipated changes to Schedule-M by the central government, TSDCA has issued instructions to pharmaceutical and biotech companies with turnovers below Rs 250 crore, requiring them to implement the new Schedule-M regulations within one year. For companies with turnovers exceeding Rs 250 crore, the implementation period is shortened to six months. This move aims to align Indian pharmaceutical and biotech industries with international cGMP standards, which could lead to easier approvals from international regulatory bodies for exporting Indian pharmaceutical and biotech products. The Director General emphasises that small and medium-scale pharma and biotechnology enterprises should prioritise adherence to cGMP and quality control standards over increasing production capacity. TSDCA employs a two-pronged strategy for inspecting manufacturing units, including joint targeted inspections with the Central Drugs Standard Control Organization (CDSCO) and risk-based surprise inspections. These measures enable TSDCA to uphold the Drugs and Cosmetics Act, ensuring the availability of high-quality medicines for consumers and patients. The Director General of TSDCA encourages vigilance among citizens and industry stakeholders to combat the proliferation of counterfeit and substandard drugs. While TSDCA and the CDSCO fulfill their roles in implementing drug regulations, the responsibility for creating a better society free from substandard drugs lies with all stakeholders.   Amguthr Raju ]]> https://biospectrumindia.com/news/22/23724/allegations-of-corruption-surround-telangana-pharmacy-council-officials.html https://biospectrumindia.com/news/22/23724/allegations-of-corruption-surround-telangana-pharmacy-council-officials.html Thu, 19 Oct 2023 00:00:00 +0530 The Telangana Pharmacy Council is embroiled in allegations of corruption concerning the registration and renewal processes for newly graduated candidates within the state. According to credible sources within the Pharmacy Council and reports from candidates, it has come to light that at least four out of every five individuals have encountered instances of corruption when dealing with council officials. Approximately 150 candidates approach the council daily seeking new registrations and certificate renewals. Shockingly, many are compelled to pay sums ranging from Rs 1,000 to Rs 2,000 and even more to expedite their paperwork. As the Pharmacy Council elections are set to commence today, on October 19, 2023, concerns have arisen regarding the potential manipulation of the electoral process. Council officials have stated that they have implemented rigorous measures to ensure the elections proceed smoothly and without any irregularities. While some temporary and permanent officials are suspected of engaging in corrupt activities, Telangana state Pharmacy Council (TSPC) Registrar Yogananda vehemently denied these allegations, emphasising their commitment to conducting the elections with integrity.   Amguthr Raju ]]> https://biospectrumindia.com/news/22/23693/govt-launches-global-health-innovation-fellowship-to-promote-medtech-sector.html https://biospectrumindia.com/news/22/23693/govt-launches-global-health-innovation-fellowship-to-promote-medtech-sector.html Sat, 14 Oct 2023 00:00:00 +0530 Union Minister for Science and Technology, Dr Jitendra Singh presided over the launch of the DBT and World Intellectual Property Organization (WIPO) supported Global Health Innovation Fellowship to promote medtech startups and innovators among youth. The Minister informed that the Department of Biotechnology (DBT) and WIPO fellowships will be implemented in the DBT Bio-design centres at IIT Delhi and AIIMS, New Delhi; IIT-B and Hinduja and Nanavati Hospital, Mumbai. Lauding the efforts of the DBT and WIPO, Dr Jitendra Singh remarked, “This is a flagship partnership and must be strengthened to enable India attain global leadership in innovation and startup promotion”. WIPO has initiated a formal collaboration with the DBT to support four WIPO-supported Fellows to participate in the DBT Bio-design Programme. The partners received 157 applications from young professionals across the world including low- and middle-income countries. DBT has scaled up Biodesign programme by twinning over 20 medical and technical institutions across the country and World Intellectual Property Organization (WIPO) has recognised this program for support under their Global Health challenges initiative. Dr Rajesh S. Gokhale, Secretary, Department of Biotechnology, Government of India said “This partnership will enable us to co-develop national, regional and global institutional capacities of innovators across regions to collaboratively address global health challenges, including by promoting Global South-South cooperation”. ]]> https://biospectrumindia.com/news/22/23680/st-minister-addresses-8th-cahotech-annual-international-healthcare-technology-conference.html https://biospectrumindia.com/news/22/23680/st-minister-addresses-8th-cahotech-annual-international-healthcare-technology-conference.html Mon, 09 Oct 2023 00:00:00 +0530 Amidst global competition for hi-tech medical devices, India has emerged among the world's top five healthcare manufacturers, but at a much lesser cost, said Dr Jitendra Singh, Union Minister of Science & Technology, Government of India. India is manufacturing life-saving high-risk medical devices but the cost is just a fraction of the rest, he said. The Minister was delivering the Inaugural Address at the 8th CAHOTECH, Annual International Healthcare Technology Conference, organised by Consortium of Accredited Healthcare Organisations (CAHO) in New Delhi, on 7th October. “India is set to become the global hub of medical technology and devices with the market size estimated to grow up to $50 billion by 2050 from the present $11 billion (approximately Rs 90,000 crore),” he said. "From a market share of 1.5 per cent, we hope to increase India’s market share to 10-12 per cent over the next 25 years,” he added. The Central Government is supporting the setting up of 4 Medical Devices Parks in the States of Himachal Pradesh, Madhya Pradesh, Tamil Nadu and Uttar Pradesh. Under the PLI scheme for medical devices, till now, a total of 26 projects have been approved, with a committed investment of Rs 1,206 crore and out of this, so far, an investment of Rs 714 crore has been achieved. Out of the 26 projects, 14 projects producing 37 products have been commissioned and domestic manufacturing of high-end medical devices has started which include Linear Accelerator, MRI Scan, CT-Scan, Mammogram, C-Arm, MRI Coils, high end X-ray tubes, etc.  Dr Jitendra Singh said, technologies such as the ones developed by the Sree Chitra Tirunal Institute of Medical Sciences and Technology, Thiruvananthapuram, like the artificial heart valve, hydrocephalus shunt, oxygenator and drug eluting intra uterine device are being manufactured in the US, Japan, Brazil and China. ]]> https://biospectrumindia.com/news/22/23674/new-version-of-schedule-m-to-ensure-compliance-with-standards-of-drugs-and-promote-exports-dr-eswara-reddy.html https://biospectrumindia.com/news/22/23674/new-version-of-schedule-m-to-ensure-compliance-with-standards-of-drugs-and-promote-exports-dr-eswara-reddy.html Sat, 07 Oct 2023 00:00:00 +0530 "With gene and stem cell therapy among others coming up as new frontiers in healthcare today, personalised medicine, biotechnology and advanced therapies are driving the need for revision of Schedule M", said Dr Eswara Reddy, Joint Drugs Controller, Central Drugs Standard Control Organisation (CDSCO) while speaking on the sidelines of a workshop on “Revision of Schedule M” in Mumbai recently. The workshop was organised by the CDSCO in association with the Indian Drug Manufacturers’ Association (IDMA). He further described the need for revision of Schedule M, Good Manufacturing Practice (GMP) requirements keeping in mind current changes in the concept of quality of drugs, convergence of Indian standards with global standards, and technological advancements in manufacturing and testing of drugs. The Union health ministry had, on August 2, 2023, notified a 6 to 12 months deadline for the pharma industry to implement revised Schedule M. It had given six months time for small manufacturers and 12 months time to large units, to get their World Health Organisation-Good Manufacturing Practices (WHO-GMP) certification.  Larger companies with a turnover of over Rs 250 crore have been asked to implement the changes within 6 months, while medium and small-scale enterprises with a turnover of less than Rs 250 crore have been asked to do so within one year.  Dr Reddy further explained, “The revised Schedule M has mandatorily stipulated product quality review on an annual basis for quality risk management. This majorly includes reviewing all batches that had failed, review of non-conformance related investigations, corrective and preventive action (CAPA) taken, review of complaints and recalls, and qualification status of equipment such as heating, ventilation, air conditioning, water and compressed gases.”   Dr Reddy reiterated that the new version of Schedule M is designed to ensure compliance to the standards of drugs, promote exports, promote innovation and also to build trust and confidence in the quality of drugs manufactured and sold.  Schedule M prescribes requirements to the manufacturing plants of pharmaceutical companies for maintenance, manufacturing, control and safety testing, storage and transport of material, written procedures and records, traceability etc. The revised GMP guidelines have come at a relevant time when India is reinforcing itself as the global pharmaceutical manufacturing hub. IDMA has organised a series of events in the last two years to advance the cause of the nation and the Indian pharmaceutical industry, especially the MSME sector. “IDMA will continue to organise more such value-additive events in future,” said IDMA President Dr Viranchi Shah.  Observation from ongoing risk-based inspections necessitated the government to take a relook at the current GMP regulations and Quality Management Systems (QMS) being followed by pharmaceutical manufacturers. It was revealed that some pharmaceutical firms have come under the scanner due to unethical practices like poor documentation, lack of process and analytical validations, absence of self-assessment and quality failure investigation among others. GMP comprises mandatory standards that build and bring quality to products by way of control on materials, methods, machines, processes, personnel, facility or environment, etc. The GMP system was first incorporated in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945, and the last amendment was made in June 2005. WHO-GMP standards are now part of the revised Schedule M. Schedule M prescribes requirements of facilities and their maintenance, personnel, manufacture, control and safety testing, storage and transport of material, written procedures and records, and traceability among others.  Some of the major changes which will happen with the introduction of the revised Schedule M are the introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, change control management, self-inspection, quality audit team, suppliers audit and approval, stability studies as per recommended climate condition, validation of GMP-related computerised system and specific requirements for manufacturing of hazardous products among others.    A draft notification was issued on October 5, 2018, to upgrade and synchronise the Schedule M of the Drugs and Cosmetics (D&C) Rules, 1945 in compliance with WHO-GMP standards.  In 2001, the Second Amendment to the GMP was made based on 1992 WHO GMP guidelines. These guidelines were effective from December 11, 2001, for new units and January 1, 2004, for existing units which were further extended for one year.   Bhagwati Prasad ]]> https://biospectrumindia.com/news/22/23672/stakeholders-convene-to-build-roadmap-for-strengthening-cervical-cancer-screening-in-karnataka.html https://biospectrumindia.com/news/22/23672/stakeholders-convene-to-build-roadmap-for-strengthening-cervical-cancer-screening-in-karnataka.html Fri, 06 Oct 2023 00:00:00 +0530 The Government of Karnataka, Directorate of Health and Family Welfare Services and FIND recently organised a policy consultation in Bengaluru to engage with key stakeholders on identifying strategies to strengthen screening for cervical cancer in Karnataka. The consultation was inaugurated by Dinesh Gundu Rao, the Minister for Health and Family Welfare, who highlighted Karnataka’s commitment to prioritising cervical cancer elimination as a model for the country. During the discussions, the introduction of World Health Organization (WHO)-recommended high-performance HPV DNA tests, complemented by self-collection of samples to ensure effective screening, were emphasised as critical components of a robust cervical cancer elimination strategy. Dr Sanjay Sarin, Vice President Access at FIND, said: “One woman dies every 2 minutes from cervical cancer, yet it is a preventable and curable disease. The WHO strategy for cervical cancer elimination calls for at least 70% of women to be screened for cervical cancer using a high-performance HPV test by the time they are 35 years old, and again by age 45. We welcome the Government’s commitment to accelerate progress towards these targets, and the roadmap developed in Karnataka is a critical step towards that goal that will provide a model for the country. We continue to pledge our support and diagnostic expertise to protect women and girls by beating this deadly disease.” The meeting was made possible with the support of Roche Diagnostics. Dr Thilo Brenner, APAC Sub-Region Head (India, Indonesia, Myanmar, Pakistan, and the Philippines), Roche Diagnostics, said, “By educating women and expanding access to HPV screening, we aim to drive systemic and behavioural change in the management of cervical cancer.” ]]> https://biospectrumindia.com/news/22/23602/karnataka-govt-unveils-bengaluru-declaration-of-ficci-cancer-care-task-force.html https://biospectrumindia.com/news/22/23602/karnataka-govt-unveils-bengaluru-declaration-of-ficci-cancer-care-task-force.html Sat, 16 Sep 2023 00:00:00 +0530 Dinesh Gundu Rao, Minister for Health and Family Welfare, Government of Karnataka, recently unveiled a comprehensive nine-target strategy as part of the Bengaluru-Declaration of FICCI Cancer Care Task Force. This initiative is dedicated to significantly reducing premature deaths caused by cancer, improving the quality of life as well as elevating cancer survival rates in the State.   The FICCI Cancer Care Task Force requested the Government of Karnataka to provide emphasis on the below key focus areas to improve the status of cancer care in the State- Drive screening coverage for cervical, breast and oral cancers in a significant manner. Also embed a robust gatekeeping and referral pathway for positive screened patients   Focus on increasing access to comprehensive cancer care facilities including medical, surgical and radiation oncology   Expand coverage under the Ayushman Bharat- Arogya Karnataka (AB-ArK) scheme to also include advanced treatment options   Evaluate the creation of State Level Advisory Body to enable implementation of Standardised Treatment Protocols and eligibility criteria for empanelment of hospitals to provide cancer care under AB-ArK scheme   Focus on creating mass awareness about risk factors (beyond tobacco use), prevention, symptoms, options for diagnosis and treatment. Earlier, the FICCI-EY Report 2022, developed under FICCI Task Force on Cancer Care Infrastructure highlighted that it is imperative that the country focuses on effective prevention, targeted screening, and large-scale awareness as the primary response to addressing the disease burden by avoiding the unnecessary stigma attached to cancer.   ]]> https://biospectrumindia.com/news/22/23539/govt-invests-rs-5000-cr-over-5-yrs-for-promotion-of-research-and-innovation-in-pharma-medtech-sector.html https://biospectrumindia.com/news/22/23539/govt-invests-rs-5000-cr-over-5-yrs-for-promotion-of-research-and-innovation-in-pharma-medtech-sector.html Fri, 01 Sep 2023 00:00:00 +0530 The Department of Pharmaceuticals has announced the Scheme for Promotion of Research and Innovation in Pharma MedTech Sector (PRIP). The scheme would have a financial outlay of Rs 5,000 crore, over a period of 5 years from financial year 2023-24 to 2027-28. The objective of the scheme is to transform Indian Pharma MedTech sector from cost based to innovation-based growth by strengthening the research infrastructure in the country. As part of the scheme, it has been proposed to establish Centres of Excellence (CoEs) in the seven existing National Institute of Pharmaceutical Education & Research (NIPERs) at Mohali, Ahmedabad, Hyderabad, Guwahati, Kolkata, Hajipur and Raebareli at a tentative cost of Rs 700 crore over a period of five years in following specialisations: i. NIPER Mohali- Anti-Viral and Anti- Bacterial Drug Discovery and Development ii. NIPER Ahmedabad- Medical Devices iii. NIPER Hyderabad- Bulk Drugs iv. NIPER Kolkata- Flow Chemistry and Continuous Manufacturing v. NIPER Raebareli- Novel Drug Delivery System vi. NIPER Guwahati- Phyto-pharmaceuticals vii. NIPER Hajipur- Biological Therapeutics This will help in building specific research capacities in the identified priority areas in a focused time bound programme, tapping industry-academia linkage. Further, the scheme shall cover pharmaceutical research under six priority areas- New Chemical Entity (NCE), New Biological Entity (NBE), Phyto-pharmaceuticals (natural product); Complex generics; Biosimilars; Medical devices; Orphan drugs; and Drug development for anti-microbial resistance (AMR). ]]> https://biospectrumindia.com/news/22/23520/we-are-coming-up-with-coes-for-health-science-medical-devices-priyank-kharge.html https://biospectrumindia.com/news/22/23520/we-are-coming-up-with-coes-for-health-science-medical-devices-priyank-kharge.html Mon, 28 Aug 2023 00:00:00 +0530 “We are coming up with Centres of Excellence (CoEs) for health science & medical devices and also a circular economy lab, all of which we wish to collaborate with ecosystems of countries from across the globe,” said Priyank Kharge, Minster for Information Technology (IT) and Biotechnology (BT), Government of Karnataka. Speaking at the Global Innovation Alliance (GIA) Partners Meet held on August 28, 2023 in Bangalore, the Minister said “Karnataka is taking bold steps to weave together a Global Innovation Alliance (GIA) with as many countries to facilitate regular knowledge and idea exchanges, fostering innovation and investment on a global scale. Through this initiative, countries within the alliance host technology sessions, where ecosystem connections, the exchange of ideas and people, and discussions on policy environments will take place. The participation of minister-level delegations from key GIA partner countries will further strengthen these engagements.” Kharge further said “Through international collaborations, we gain access to diverse perspectives, experiences, and ideas. We foster a culture of open dialogue and shared learning, where breakthroughs in one corner of the world can inspire innovation in another. This not only accelerates the pace of discovery but also enhances the impact of technological solutions on a global scale.” He continues to add that moreover, collaborations amplify the potential for investment and economic growth. By combining resources, he said “we create a more attractive environment for investors and entrepreneurs. This paves the way for the creation of new industries, the development of emerging technologies, and the generation of high-skilled jobs. “ The Minister concluded his address by inviting the country representatives in India, “Let us embrace our shared future and seize this moment to forge partnerships that transcend borders and bridge gaps. By working together, we can harness the power of technology to build a brighter, more inclusive, and sustainable world for generations to come.”   ]]> https://biospectrumindia.com/news/22/23493/dbt-signs-implementation-arrangement-with-united-states-national-science-foundation-.html https://biospectrumindia.com/news/22/23493/dbt-signs-implementation-arrangement-with-united-states-national-science-foundation-.html Thu, 24 Aug 2023 00:00:00 +0530 Union Minister of State (Independent Charge) Science & Technology Dr Jitendra Singh said that India is set to achieve $150 billion Bio-Economy  by 2025, which stood at over $100 billion in 2022. The Minister was speaking, while overseeing the signing up of the ‘Implementation Arrangement’ between the Department of Biotechnology (DBT) and the United States-National Science Foundation (US-NSF) recently in New Delhi.  This was a follow-up of the discussion meeting held between Dr Rajesh S. Gokhale. Secretary, DBT and Dr Sethuraman Panchanathan, Director, NSF in June, 2023 to discuss opportunities for developing ‘Strategic Partnership’ between DBT and US-NSF. The ‘Implementation Arrangement’ will lay the foundation for collaboration between the two countries on accelerating innovations in the area of ‘Biotechnology Innovation and Biomanufacturing’. This will advance knowledge, technologies, and innovation through supportive collaborative research to empower biotechnology industries and promote bioeconomy of both the countries. US National Science Foundation (US-NSF) is an independent federal agency that supports science and engineering in the United States. It was established to promote the progress of science, advance the national health, prosperity and welfare, and secure national defence, through administering grants. ]]> https://biospectrumindia.com/news/22/23507/why-india-must-push-for-relaxation-of-canadian-fixed-drug-price-policy.html https://biospectrumindia.com/news/22/23507/why-india-must-push-for-relaxation-of-canadian-fixed-drug-price-policy.html Thu, 24 Aug 2023 00:00:00 +0530 Experts have recommended the Indian government should emphasise the need to broaden the scope of pharmaceutical equivalence among other intellectual property (IP) related subjects to Canada considering India’s strength as a generic provider. For a generic drug to be considered equivalent to the patented drug in Canada, the generic drug must contain an ‘identical amount of identical medicinal ingredients’ as the patented drug. Legislative changes have been proposed to widen the scope of such equivalence, but these are yet to be codified into law. Canada does not grant any exclusivity period for marketing generic drugs. However, Canada does have a provision which rewards the generic drugs company for the expense and risk of challenging patents.  Therefore, the Indian government may also emphasise the need for such exclusivity to incentivise the generic industry.   Canadian law provides for expedited drug review processes in exceptional cases such as reviews of drugs for life-threatening diseases. However, the criteria applied to trigger expedited review are not clear. The Indian government may also discuss the possibility of extending the scope of coverage of expedited approvals to other categories of drugs and may seek greater clarity on the criteria and processes involved. In the USA, the first maker of any generic drug that challenges an existing patent is entitled to a 180-day period of exclusivity during which no other generic for the same patented drug can be marketed. A Drug Establishment License is required for any company that fabricates, packages, labels, distributes, imports, wholesales, and/or tests drugs. Sumanta Choudhury, Advisor, Pharmaceuticals Export Promotion Council of India (Pharmexcil) explains, “Canada accords ‘innovative drugs’ with market exclusivity for 8 years. As mentioned previously, there is no exclusivity for the first generic manufacturer. As a part of the Canada-European Union Comprehensive Economic and Trade Agreement, new pharmaceutical products are granted additional exclusivity through the protection of an eligible patent. As a result, the actual exclusivity period for products from the European Union would increase from 8 to 10 years through the operation of a ‘patent linkage system’.  These provisions form part of Canada’s free trade agreement obligations, so it is unlikely that these would be altered in the near future”.  “However, India may still flag the issue as causing inordinate delays in generic drug approvals. There is a lack of a formal patent opposition framework in Canada. India has established formal procedures for pre- and post-grant opposition. During negotiations, India should not make any commitment relating to altering its patent opposition system,” adds Choudhary.   “The Canadian Supreme Court has interpreted Canadian patents to have extraterritorial application, namely the Saccharin Doctrine which broadly states that if a drug is produced with a patented intermediate, such drug would infringe the patent for the intermediate when the final product is imported and sold in Canada. The Doctrine includes both products and processes. The Indian government should strongly put forth the position that patent protection should be limited to Canadian territory during negotiations,” Choudhury further explains. India and Canada have a similar stance on compulsory licensing, especially on life-saving medicine such as the COVID-19 vaccines. However, India is keen on expanding the scope of such waivers to diagnostics and therapeutics and may liaise with the Canadian government on its position regarding such waivers.   Bhagwati Prasad ]]> https://biospectrumindia.com/news/22/23482/mysurus-vipragen-biosciences-receives-second-investment-round-from-karnataka-governments-venture-fund.html https://biospectrumindia.com/news/22/23482/mysurus-vipragen-biosciences-receives-second-investment-round-from-karnataka-governments-venture-fund.html Tue, 22 Aug 2023 00:00:00 +0530 "We are thrilled to receive this investment from KITVEN and Conscience Multi Family Office," said Dr. Chandrashekaran. "This funding will empower us to further enhance our operations and expand our reach into new sectors, such as Nutraceuticals, Agrochemicals and Medical Devices. With a surge of interest in global strategic partnerships within the preclinical CRO space, Vipragen is uniquely positioned to capitalize on its niche expertise and solid business foundation.   Mr. Jayakumar CEO KITVEN said “Vipragen with its world class facilities and range of service offerings is on the threshold of becoming one of the leading CRO providers for Pharmaceutical companies and research organisations'. Commenting on the transaction, Vignesh Sundararaman, Founding Partner at Conscience MFO, stated, "The preclinical CRO landscape has witnessed a significant uptick in M&A activities, highlighting the value of specialized expertise and quality services. We are excited to join forces with Vipragen and contribute to its growth trajectory." QuantAscend Consulting Global, our CFO Advisors, led and advised the investment transaction. Vipragen had previously received funding from KITVEN and benefitted from collaborative projects supported by BIRAC. Incubated at the Centre for Cellular and Molecular Platforms (CCAMP) in Bangalore, this fund will empower Vipragen to scale up its current operations and explore new horizons in Nutraceuticals, Agrochemicals and Medical Device sectors. Dr. Chandrashekaran, Founder Chairman of Vipragen, expressed optimism about India's growing prominence as a global research hub, stating, "Our vision is to attract more international companies to leverage India's thriving research ecosystem." ]]> https://biospectrumindia.com/news/22/23469/government-launches-new-healthcare-portals-to-fulfill-global-responsibilities.html https://biospectrumindia.com/news/22/23469/government-launches-new-healthcare-portals-to-fulfill-global-responsibilities.html Fri, 18 Aug 2023 00:00:00 +0530 Addressing the ‘One Earth, One Health - Advantage Healthcare India 2023 (AHCI)’, organised by the Ministry of Health and Family Welfare, Govt of India and Federation of Indian Chambers of Commerce & Industry (FICCI) in Gandhinagar, Union Health Minister, Dr Mansukh Mandaviya launched the ‘The Advantage Health Care India - One Stop Digital Portal For Patient’ and ‘Workforce Mobility’, stating  thatthe launch of these two portals is not just a milestone for India, but a significant step towards fulfilling our global responsibilities. "India has always been at the forefront of healthcare innovation.” Dr Mandaviya further added “Through these portals, we are offering a tangible solution to some of the most, pressing challenges in healthcare today.” Elaborating on the Indian health system, the Health Minister cited that India today is supported by a workforce of 1.3 Million Allopathic Doctors, 800,000 AYUSH doctors and 3.4 Million Nurses & Auxiliary Nurse and Midwives. Through this highly qualified and skilful workforce, India plans to contribute to an organised system of workforce mobility, wherein India’s healthcare professionals travel to different parts of the world, to serve the global community.  Dr Mandaviya further emphasised that medical value travel will enable greater knowledge-sharing, sustainable partnerships and increased synergies contributing to building a stronger global health architecture.  Sarbananda Sonowal noted that the theme of India G20 Presidency ‘One Earth, One Family, One Future’ incorporates medical value travel and health workforce mobility as an important facet in its pursuit to build resilient global healthcare systems.  ]]> https://biospectrumindia.com/news/22/23451/india-starts-second-phase-of-nationwide-mass-drug-administration-initiative-for-lymphatic-filariasis.html https://biospectrumindia.com/news/22/23451/india-starts-second-phase-of-nationwide-mass-drug-administration-initiative-for-lymphatic-filariasis.html Thu, 10 Aug 2023 00:00:00 +0530 “India is committed to eliminating Lymphatic Filariasis by 2027, three years ahead of the global target through mission mode, multi partner, multi sector targeted drive.” This was stated by Union Minister for Health & Family Welfare, Dr Mansukh Mandaviya as he inaugurated the second phase of the Annual Nationwide Mass Drug Administration (MDA) initiative. The Union Minister further stressed that “Through Jan Bhagidaari and ‘Whole of Government’ and ‘Whole of Society’ approach, we shall be able to eliminate this disease from the country”. The second phase, commencing on August 10, 2023, will cover 81 districts in 9 endemic States (Assam, Bihar, Chhattisgarh, Jharkhand, Karnataka, Maharashtra, Odisha, Telangana and Uttar Pradesh).          The Union Health Minister also stressed on enhancing synergy between state and central governments for ensuring a healthier nation for all. Enumerating the success of Jan Andolan movements in health by citing the example of Ni-kshay Mitra among others, Dr Mandaviya highlighted that “community engagement will contribute significantly in garnering success in this mission by the involvement of all stakeholders starting from the grassroot levels.” Underscoring the wide reach of mass movement, the Health Minister further added “Incorporating awareness generation, and ensuring communication campaigns at villages, panchayats will galvanise the movement leading to wide reach across the nation.” To further strengthen efforts, Dr Mandaviya advocated that greater emphasis should be placed in consumption of medicine in front of healthcare workers or professionals as measure in eradicating this disease. The occasion witnessed the launch of National Guidelines for Clinical Management of Dengue Fever 2023 and Chikungunya Fever by Dr Mandaviya. ]]> https://biospectrumindia.com/news/22/23435/ten-stakeholders-jointly-seek-recall-of-new-drugs-cosmetics-medical-devices-bill-2023-.html https://biospectrumindia.com/news/22/23435/ten-stakeholders-jointly-seek-recall-of-new-drugs-cosmetics-medical-devices-bill-2023-.html Fri, 04 Aug 2023 00:00:00 +0530 Foreseeing the devastating impact of the New Drugs, Cosmetics & Medical Devices Bill, 2023 on the domestic players and India’s preparedness to deal with any pandemic like situation, multiple stakeholders have joined hands and want the New Drugs, Cosmetics & Medical Devices Bill to be recalled. In a joint plea made by the Indian medical device manufacturers, patient interest groups, users and hospitals to Union Health Minister Dr Mansukh L Mandaviya, they have articulated their concerns and have sought the recall of the Bill in the larger interests of the nation and budding indigenous manufacturers of medical equipment, who are playing a pivotal role in bringing resilience in the country’s MSME sector.     In the joint letter, they have called for a consultation meeting with a fresh committee under the Chairmanship of ICMR/DST/DBT and key stakeholders for discussing feedback from them and careful consideration of their suggestions before finalising the draft of the Bill and submitting it to the Parliament.   Talking about the Bill, Dr Girdhar Gyani, Director General, Association of Healthcare Providers India, said that “if the bill is implemented, the Medical Devices Manufacturing sector may face supply chain crisis and effectively lose its ability to meet domestic demand, hence in a wider interest the draft bill needs to be reviewed for its effective implementation.   According to Prof Bejon Misra, Founder Director, Patient Safety and Access Initiative of Foundation India, The Bill was drafted through a flawed process by a Committee of Regulators by sharing the initial draft on the website of MoH&FW and did not thereafter hold any kind of consultation meeting with many integral stakeholders for discussing feedback from them and also did not implement any suggestions made by us before finalising the draft for submitting it to the Parliament.   ]]> https://biospectrumindia.com/news/22/23441/rajya-sabha-passes-jan-vishwas-bill-2023-in-parliament-with-amendments-in-pharmacy-regulations.html https://biospectrumindia.com/news/22/23441/rajya-sabha-passes-jan-vishwas-bill-2023-in-parliament-with-amendments-in-pharmacy-regulations.html Fri, 04 Aug 2023 00:00:00 +0530 The Jan Vishwas (Amendment of Provisions) Bill, 2023 was passed in Lok Sabha on 27th June 2023 and Rajya Sabha on 2nd August 2023, with removal of stringent punishments such as imprisonment from some of the provisions of the Drugs and Cosmetics Act, 1940 and the Pharmacy Act, 1948. The Jan Vishwas Bill was drafted to amend 42 laws administered by 19 ministries. The objective behind the Bill is to do away with "outdated rules" of criminal punishment and imprisonment for several minor offences. The Bill seeks to make two amendments to the Drugs and Cosmetics Act, of 1940 — the Act that regulates the import, manufacture and distribution of drugs in India. Currently, the Act defines four categories of offences— adulterated drugs, spurious drugs, mislabeled drugs, and Not of Standard Quality drugs (NSQs) — and lays out degrees of punishment (a combination of prison time and fine) based on the degree of offence. Section 27(d) specifically deals with offenses of misbranding and Not of Standard Quality Drugs (NSQs), which currently require up to two years of imprisonment and a fine of up to Rs 20,000.  According to the Bill passed by the Lok Sabha, the Drugs and Cosmetics Act, 1940 will have a few provisions where the imprisonment will be substituted with provisions for penalty. Under the Pharmacy Act, 1948, one of the amendments is to remove provisions for imprisonment for six months or fine of one thousand ruppes or both, to penalty up to Rs. 1 lakh under Section 26A. Similarly a new section will be inserted after Section 43, named as 43A to deal with adjudication of penalties. ]]> https://biospectrumindia.com/news/22/23416/govt-releases-national-deep-tech-startup-policy-draft-for-public-consultation.html https://biospectrumindia.com/news/22/23416/govt-releases-national-deep-tech-startup-policy-draft-for-public-consultation.html Tue, 01 Aug 2023 00:00:00 +0530 National Deep Tech Startup Policy (NDTSP) Consortium has announced the draft policy for public consultation; seeking public feedback till September 15, 2023.  The Prime Minister's Science, Technology, and Innovation Advisory Council (PM-STIAC), in its 21st meeting held on July 7, 2022, recommended the creation of a National Consortium and a Working Group to propose a comprehensive policy framework to address the needs and strengthen the Indian deep tech startup ecosystem. Chaired by the Principal Scientific Adviser to the Government of India, Prof. Ajay Kumar Sood, the apex-level National Consortium represents a broad spectrum of stakeholders. Under the overall guidance of the National Consortium, steered by the Expert Working Group, a draft version of the National Deep Tech Startup Policy (NDTSP) has been developed through an extensive multi-stakeholder consultative process involving startups, incubation centres, industry associations, academic institutions, and relevant government agencies. The draft NDTSP captures various new policy instruments and suggests necessary policy changes under the following themes: Nurturing Research, Development & Innovation Strengthening the Intellectual Property Regime Facilitating Access to Funding Enabling Shared Infrastructure and Resource Sharing Creating Conducive Regulations, Standards, and Certifications Attracting Human Resources & Initiating Capacity Building Promoting Procurement & Adoption Ensuring Policy & Program Interlinkages Sustaining Deep Tech Startups   ]]> https://biospectrumindia.com/news/22/23408/national-health-authority-launches-100-microsites-project-to-accelerate-digital-health-adoption.html https://biospectrumindia.com/news/22/23408/national-health-authority-launches-100-microsites-project-to-accelerate-digital-health-adoption.html Fri, 28 Jul 2023 00:00:00 +0530 In the endeavour to promote digital health adoption and hence make healthcare more accessible to all, the National Health Authority (NHA) has launched 100 Microsites Project under Ayushman Bharat Digital Mission (ABDM). A Microsite, within the context of ABDM, shall be a cluster of all small and medium scale clinics, nursing homes, hospitals (preferably <10 bedded), labs, pharmacies and other healthcare facilities that are ABDM-enabled and offer digital health services to the patients. These Microsites would be established across the country in various states/UTs, majorly implemented by State Mission Directors of Ayushman Bharat Digital Mission while the financial resources and overall guidance would be provided by National Health Authority. The Microsites aim to establish a small ecosystem within a particular geographic area where there is complete ABDM adoption, and the entire patient journey is digitised. The State/UT may leverage a development partner and an interfacing agency for setting up and running the microsite. Within the microsite, all health facilities and healthcare professionals serving across different systems of medicines, especially from the private sector, shall be registered in ABDM modules like Healthcare Professionals Registry (HPR), Health Facility Registry (HFR) followed by installation of ABDM enabled applications.  The patients visiting these centres will also become a part of ABDM with their health records linked to their ABHA which would then be accessible to them on their mobile phone applications like ABHA App, Aarogya Setu among others. Talking about the project, S. Gopalakrishnan, CEO, NHA said – “We aim to establish 100 such Microsites across the country where focused efforts would be made to bring as many small-medium scale healthcare entities under the ABDM fold. This will not only increase adoption among private sector providers but will also help ABDM to expand its footprints among the private healthcare providers across the country as well.”   ]]> https://biospectrumindia.com/news/22/23400/india-fosters-advancements-in-ai-emerging-technologies.html https://biospectrumindia.com/news/22/23400/india-fosters-advancements-in-ai-emerging-technologies.html Thu, 27 Jul 2023 00:00:00 +0530 In order to foster collaboration in the field of artificial intelligence (AI) and Emerging Technologies, ‘India AI’ – an IBD under Digital India Corporation and Meta, India have signed a Memorandum of Understanding (MoU).  The objective of the MoU is to establish a framework for collaboration and cooperation between ‘India AI’ and Meta in the field of Artificial Intelligence & Emerging Technologies including to make Meta’s open-source AI models available for use by Indian AI ecosystem. ‘India AI’ and Meta have entered into a collaboration aimed at advancing research and development in AI & Emerging Technologies, seeking breakthroughs in AI technology and its applications. Additionally, both organisations may also consider establishing a Centre of Excellence to nurture the startup ecosystem of AI & other Emerging Technologies. Leveraging Meta's AI research models like LlaMA, Massively Multilingual Speech, and No Language Left Behind, the partnership will focus on building datasets in Indian Languages to enable translation and large language models, with priority given to low-resource languages. This effort will foster social inclusion, improve government service delivery, and spur innovation using large language models, Generative AI, cognitive systems, and translation models. Furthermore, ‘India AI’ and Meta will strive to enhance accessibility to AI compute resources for researchers, startups, and organisations with limited resources. Knowledge sharing and collaboration in AI & Emerging Technologies will be facilitated through workshops, seminars, conferences, and similar platforms.     ]]> https://biospectrumindia.com/news/22/23387/india-and-argentina-agree-for-bilateral-exchange-of-biotech-researchers-startups.html https://biospectrumindia.com/news/22/23387/india-and-argentina-agree-for-bilateral-exchange-of-biotech-researchers-startups.html Mon, 24 Jul 2023 00:00:00 +0530 India and Argentina have agreed for a bilateral exchange of young researchers and startups, particularly in the field of biotechnology and agriculture. This was stated by Union Minister of State (Independent Charge) Science & Technology Dr Jitendra Singh when the Governor of Santa Fe province of Argentina, Omar Angel Perotti called on him, accompanied by a high-level delegation. Dr Jitendra Singh mentioned that a new Indo-Argentina call for joint proposals was launched on February 7, 2023 in the research areas of Energy Transition and Biotechnology jointly during his meeting with Argentina's Minister of Science, Technology and Innovation, Daniel Filmus in New Delhi. A total of 82 joint proposals were received under the said call. These are under the evaluation process. Governor of Santa Fe province mentioned that Santa Fe is the hub of R&D institutions in Biotechnology and Agricultural research especially in Soyabean, and close tie ups with universities and industry in the province. Pioneering work has been done here in disease resistant seed production, he said. The Indian delegation evinced interest in collaborating in geospatial technology, quantum computation and bio-enzymes. India is the 4th largest trading partner of Argentina, with bilateral trade touching a historic peak of $6.4 billion in the year 2022, recording a growth rate of 12% over 2021. Exports from India to Argentina was worth $1.84 billion (31% growth rate) while India’s imports from Argentina was worth $4.55 billion. ]]> https://biospectrumindia.com/news/22/23364/india-chamber-of-business-and-commerce-signs-moa-with-icmr-to-build-future-of-indian-healthcare-.html https://biospectrumindia.com/news/22/23364/india-chamber-of-business-and-commerce-signs-moa-with-icmr-to-build-future-of-indian-healthcare-.html Thu, 20 Jul 2023 00:00:00 +0530 India Chamber of Business and Commerce and Indian Council of Medical Research (ICMR) have signed a Memorandum of Agreement (MoA) at Ministry of Micro Small and Medium Enterprises (MSME) in the presence of the Minister of MSME Narayan Rane to promote India as global hub in healthcare manufacturing and delivery and for creating a global stakeholders platform for building robust healthcare ecosystem promoting future of health capabilities in India and promoting investment creation in the field of healthcare.  The MoA is in line with creating institutional arrangement for India Health Dialogue- A national flagship initiative driven by India Chamber of Business and Commerce in partnership with ICMR, IMA and Ministry of MSME to build profound business ecosystem for transforming health and healthcare for the future and building India led global supply chain networks. This partnership will also help in promoting international collaborations in innovation and technology, building healthcare delivery standards, academia and industry partnerships, capacity building and promoting  new innovations in the field of health. . ]]> https://biospectrumindia.com/news/22/23343/government-organises-chintan-shivir-to-reduce-burden-of-diseases.html https://biospectrumindia.com/news/22/23343/government-organises-chintan-shivir-to-reduce-burden-of-diseases.html Fri, 14 Jul 2023 00:00:00 +0530 “Swasthya Chintan Shivir, a national meeting, enables sharing of insights, best practices, valuable experiences, and suggestions from various states to enrich our policies aimed at designing schemes for largest beneficiary welfare.” This was stated by Union Minister of Health & Family Welfare Dr Mansukh Mandaviya as he inaugurated a two day long Swasthya Chintan Shivir- the 15th Conference of Central Council of Health and Family Welfare, in Dehradun on 14 July. He was joined by the Chief Minister of Uttarakhand, Pushkar Singh Dhami, the Chief Minister of Sikkim, Prem Singh Tamang; Union Ministers of State for Health Dr Bharati Pravin Pawar, and Prof. SP Singh Baghel, and Dr VK Paul, Member (Health), NITI Aayog. “In this Amrit Kaal, let us take inspiration from our own knowledge, and develop our own health model. We should resolve to remove burden of diseases such as Leprosy, TB, Sickle Cell Anaemia etc., from various states, and saturate states with Pradhan Mantri Jan Arogya Yojana (PM-JAY) cards”, said Dr Mandaviya. Various books including Compendium of Best Practices, Ayushman Bharat, Health and Wellness Centres- Success Stories from the Field, Research to Action-The Insights and Policy implications, and Recommendations for Medical Rehabilitation of Persons Injured after an Earthquake were released at the inaugural event. ]]> https://biospectrumindia.com/news/22/23344/ayush-health-services-and-research-facility-open-in-goa.html https://biospectrumindia.com/news/22/23344/ayush-health-services-and-research-facility-open-in-goa.html Fri, 14 Jul 2023 00:00:00 +0530 The Ministry of Ayush has established Ayush health services for healthcare & Ayush research facilities at Ribandar in Goa. The facility aims to provide high-quality and affordable Ayush healthcare services to local community and also promote research in traditional medicine by developing a museum, library and a laboratory dedicated to conducting research on medicines of mineral and marine origin. It was inaugurated by Dr Pramod Sawant, Chief Minister of Goa; Sarbananda Sonowal, Union Minister of Ayush & Ports, Shipping and Waterways;Shripad Yesso Naik, Union Minister of State for Ports, Shipping and Waterways and Tourism; Vishwajit Rane, Minister of Health, Government of Goa. Ayush Health Services for healthcare & research facilities include Central Council for Research in Ayurvedic Sciences (CCRAS) – Regional Ayurveda Research Institute for Mineral and Marine Medicinal Resources, Central Council for Research in Homeopathy (CCRH) – Clinical Research Unit (Homeopathy), Central Council for Research in Siddha (CCRS) - Siddha Clinical Research Unit, Central Council for Research in Yoga & Naturopathy (CCRYN) - Clinical Research Unit & Central Council for Research in Unani Medicine (CCRUM) – Unani Speciality clinic. Provision has been made for OPD, dispensary, panchakarma and laboratory for conducting research focusing on the medicines of Mineral and Marine origin. The Institutes will work to provide high quality and affordable healthcare to every region of the state through Ayush systems of medicine. ]]> https://biospectrumindia.com/news/22/23340/conference-on-traditional-medicines-for-asean-countries-to-open-on-20th-july-in-delhi.html https://biospectrumindia.com/news/22/23340/conference-on-traditional-medicines-for-asean-countries-to-open-on-20th-july-in-delhi.html Thu, 13 Jul 2023 00:00:00 +0530 The Ministry of Ayush with support from the Ministry of External Affairs, Indian Mission to Association of Southeast Asian Nations (ASEAN) and the ASEAN Secretariat is gearing up to host the Conference on Traditional Medicines for ASEAN Countries on 20th July 2023. The Conference on Traditional Medicines aims to strengthen the platform between India and ASEAN Countries to share their best practices and draw a roadmap for future cooperation in the field of Traditional Medicines. Addressing the Media at the Curtain Raiser event on 13 July, Union Minister for Ayush, Sarbananda Sonowal said, "The Ayush sector has grown multi-fold in the last 9 years since the year 2014. Today the Ministry is engaged with many top class international organisations from UK, USA, Japan, Brazil, Germany as well as National organisations like CSIR, DST, DBT, IITs etc. to undertake high quality research on Ayush systems in various non communicable disease conditions like Diabetes Mellitus, Cancer, Mental Health as well as infectious diseases like COVID. The ASEAN conference will provide a platform to share the research outcomes of various projects implemented by the Ministry of Ayush. Similarly, ASEAN countries will also share their experiences.” A total of 75 participants - International delegates from 8 ASEAN countries and 2 International delegates through virtual mode will brainstorm and share their ideas on Traditional Medicines during this one day conference which will be held at Vigyan Bhawan in New Delhi. ]]> https://biospectrumindia.com/news/22/23310/karnataka-govt-makes-key-announcements-for-health-budget-2023-24.html https://biospectrumindia.com/news/22/23310/karnataka-govt-makes-key-announcements-for-health-budget-2023-24.html Mon, 10 Jul 2023 00:00:00 +0530 Karnataka Chief Minister Siddaramaiah recently presented state budget, the first since Congress took power this year. Initiatives for Community Health include allocation of Rs 3 crore for 20 hand held X-ray machines to detect tuberculosis. Diabetes and blood pressure camps along with distribution of medicines at door step, as a pilot project will be implemented in 8 districts. Ophthalmology camps called ‘Ashakirana’ in 4 districts will be organised at a cost of Rs 21 crore. According to the new budget, Rs 25 crore are being allocated to extend Brain Health Initiative in collaboration with the National Institute of Mental Health and Neuro-Sciences (NIMHANS) across the State. CT (computed tomography) and MRI (magnetic resonance imaging) scanning facility will be introduced in all district hospitals. In addition, Rs 92 crore will be allocated to provide single use dialyser to all district and taluka hospitals. Dialysis centres will be increased from 173 to 219. Further, Karnataka Health Technology lab is to be established at a cost of Rs 8 crore. The Minister also announced that the first government hospital dedicated for organ transplant will be established in NIMHANS at a cost of Rs 146 crore.   ]]> https://biospectrumindia.com/news/22/23273/government-launches-national-sickle-cell-anaemia-elimination-mission-in-shahdol-mp.html https://biospectrumindia.com/news/22/23273/government-launches-national-sickle-cell-anaemia-elimination-mission-in-shahdol-mp.html Sat, 01 Jul 2023 00:00:00 +0530 Prime Minister Narendra Modi launched the National Sickle Cell Anaemia Elimination Mission in Shahdol, Madhya Pradesh (MP) on 1 July and distributed sickle cell genetic status cards to the beneficiaries. The Mission aims to address the pressing health challenges posed by sickle cell disease, particularly among the tribal population. The launch will mark a crucial milestone in the Government’s ongoing efforts to eliminate sickle cell disease as a public health problem by 2047. The National Sickle Cell Anaemia Elimination Mission was announced in the Union Budget 2023.  This will be implemented in 278 districts of 17 high-focus states in the country namely Gujarat, Maharashtra, Rajasthan, Madhya Pradesh, Jharkhand, Chhattisgarh, West Bengal, Odisha, Tamil Nadu, Telangana, Andhra Pradesh, Karnataka, Assam, Uttar Pradesh, Kerala, Bihar, and Uttarakhand. The Prime Minister also kickstarted the distribution of about 3.57 crore Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) cards in MP. The Prime Minister said that the nation is taking a big pledge of securing the lives of the people from the tribal communities, a resolution of freedom from Sickle Cell Anaemia and saving the lives of 2.5 lakh children and families that are affected by the disease.  He underlined the need for a coordinated approach of government, health personnel and tribals. He informed that blood banks are being established for the patients, arrangement for bone marrow transplant is being enhanced, and screening of Sickle Cell Anaemia is being revamped. He asked the people to come forward for screening.    ]]> https://biospectrumindia.com/news/22/23271/cabinet-approves-introduction-of-national-research-foundation-bill-2023-in-parliament-.html https://biospectrumindia.com/news/22/23271/cabinet-approves-introduction-of-national-research-foundation-bill-2023-in-parliament-.html Wed, 28 Jun 2023 00:00:00 +0530 The Union Cabinet, chaired by the Prime Minister Narendra Modi, has approved the introduction of the National Research Foundation (NRF) Bill, 2023 in the Parliament. The approved Bill will pave the way to establish NRF that will seed, grow and promote Research and Development (R&D) and foster a culture of research and innovation throughout India’s universities, colleges, research institutions, and R&D laboratories. The bill, after approval in the Parliament, will establish NRF, an apex body to provide high-level strategic direction of scientific research in the country as per recommendations of the National Education Policy (NEP), at a total estimated cost of Rs 50,000 crore during five years (2023-28). The Department of Science and Technology (DST) will be the administrative Department of NRF which will be governed by a Governing Board consisting of eminent researchers and professionals across disciplines.  NRF will forge collaborations among the industry, academia, and government departments and research institutions, and create an interface mechanism for participation and contribution of industries and State governments in addition to the scientific and line ministries. It will focus on creating a policy framework and putting in place regulatory processes that can encourage collaboration and increased spending by the industry on R&D. The bill will also repeal the Science and Engineering Research Board (SERB) established by an act of Parliament in 2008 and subsume it into NRF which has an expanded mandate and covers activities over and above the activities of SERB. ]]> https://biospectrumindia.com/news/22/23234/government-gives-eua-to-omicron-specific-mrna-based-booster-vaccine-by-gennova.html https://biospectrumindia.com/news/22/23234/government-gives-eua-to-omicron-specific-mrna-based-booster-vaccine-by-gennova.html Tue, 20 Jun 2023 00:00:00 +0530 The Department of Biotechnology (DBT) has announced that the Omicron-specific mRNA-based booster vaccine developed using the indigenous platform technology by Pune-based Gennova Biopharmaceuticals, and supported under the Mission COVID Suraksha, implemented by Biotechnology Industry Research Assistance Council (BIRAC), has got a nod from the office of the Drug Control General of India (DCGI) for Emergency Use Authorisation (EUA). DBT has facilitated establishing Gennova's mRNA-based next-generation vaccine manufacturing for developing the platform technology from proof of concept till Phase I clinical trial of the prototype mRNA-based vaccine developed against the Wuhan strain. GEMCOVAC-OM is an omicron-specific mRNA-based booster vaccine developed using the indigenous platform technology by Gennova in collaboration with DBT. Like the prototype vaccine, GEMCOVAC-OM is a thermostable vaccine, which does not require ultra-cold chain infrastructure used for other approved mRNA-based vaccines, making it easy for deployment pan India. It is delivered intra-dermally using a needle-free injection device system. When administered intradermally in participants as a booster, it generated significantly higher immune responses. The clinical outcome demonstrates the need for variant-specific vaccines for desired immune response.   ]]> https://biospectrumindia.com/news/22/23206/cdsco-approves-animal-derived-tissue-engineering-scaffold-for-wound-healing.html https://biospectrumindia.com/news/22/23206/cdsco-approves-animal-derived-tissue-engineering-scaffold-for-wound-healing.html Tue, 13 Jun 2023 00:00:00 +0530 The first indigenously developed tissue engineering scaffold from mammalian organs, an animal-derived Class D Biomedical Device that can rapidly heal skin wounds at low-cost with minimum scarring, has received approval from the Indian Drugs Controller. With this, the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), an autonomous institution of the Department of Science and Technology (DST), has become the first institution in the country to develop Class D medical devices that satisfy all statutory requirements of the Central Drugs Standard Control Organisation (CDSCO), Government of India. The concept of using animal-derived materials as advanced wound care products is not new. However, indigenous technology was so far not available for fabricating quality products that satisfy the requirements of the Drugs Controller General. Therefore, such products were imported making them expensive. Researchers of the Division of Experimental Pathology in the Biomedical Technology Wing of the institute developed an innovative technology for preparing tissue engineering scaffolds from mammalian organs. In 2017, the technology was transferred to Alicorn Medical, a startup in the technology incubation facility of the institute namely TIMed. In a recent research paper accepted for publication in Comparative Medicine, the team showed that the scaffold has the ability to mitigate fibrotic scarring in rats suffering an experimental myocardial infarction. It is expected that with the introduction of Cholederm to the Indian market, the treatment cost can be reduced from Rs 10,000 to Rs 2,000 making it more affordable to the common man. Moreover, the technology for recovering extracellular matrix from the gall bladder is not available to others and it gives a fair chance for competition in the international market. ]]> https://biospectrumindia.com/news/22/23202/health-ministry-responds-to-reports-alleging-breach-of-data-from-co-win-portal.html https://biospectrumindia.com/news/22/23202/health-ministry-responds-to-reports-alleging-breach-of-data-from-co-win-portal.html Mon, 12 Jun 2023 00:00:00 +0530 According to a few media reports, breach of data from the Co-WIN portal has been raising concerns. The data leak apparently includes personal information of Indian citizens including PAN number and Aadhaar number.  Certain posts on the social media platform Twitter have claimed using a Telegram (online messenger application) bot, the personal data of individuals who have been vaccinated is being accessed. It is reported that the BOT has been able to pull individual data by simply passing the mobile number or Aadhaar number of a beneficiary. Responding to these reports, Union Health Ministry has clarified that all such reports are without any basis and mischievous in nature.  Co-WIN portal of Health Ministry is completely safe with adequate safeguards for data privacy. Union Health Ministry has requested the Indian Computer Emergency Response Team (CERT-In) to look into this issue and submit a report. In addition, an internal exercise has been initiated to review the existing security measures of CoWIN. CERT-In in its initial report has pointed out that backend database for Telegram bot was not directly accessing the APIs of CoWIN database. ]]> https://biospectrumindia.com/features/22/23115/will-nmd-policy-unleash-sectors-full-potential.html https://biospectrumindia.com/features/22/23115/will-nmd-policy-unleash-sectors-full-potential.html Wed, 31 May 2023 00:00:00 +0530 The medical devices sector was nothing short of thanking the government for the recently announced approved policy National Medical Devices (NMD) Policy, 2023 by the Union Cabinet, chaired by Prime Minister Narendra Modi. The policy is expected to help the medical devices sector to grow from present $11 billion to $50 billion in next five years. It is being touted by experts in the medical devices sector as a positive step where the industry is likely to become Atmanirbhar which will help to make affordable high quality and safe medical devices accessible to the world. This Policy will be in addition to the existing Production Linked Incentive (PLI) schemes that are underway. Notably, till the recent 2023 Budget, the sector wasn't all too pleased  with the government’s position, as nothing substantial was announced for the sector. The sector had been seeking  reforms since the past few years and ultimately it can now heave a sigh of relief.    Key focus areas  The current policy aims to put in place a comprehensive set of focus areas for the growth of the sector in a coordinated manner. The policy aims to bring a range of interventions in a coherent manner that would facilitate focussed and efficient support and facilitation for the sector by the respective agencies. The National Medical Devices Policy, 2023 is expected to facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality and innovation. This sector is expected to realise its full potential, with the strategies, including, building an enabling ecosystem for manufacturing along with a focus on innovation, creating a robust and streamlined regulatory framework, providing support in training and capacity building programmes and promoting higher education to foster talent and skilled resources in line with the industry requirements. Encouraging domestic investments and production of medical devices complements the Government’s ‘Atmanirbhar Bharat’ and ‘Make in India’ programmes.   Ebullient industry  Experts are content with the new policy announced with many mentioning that the move will unleash the sector's full potential, facilitating the development of patient-centric solutions to meet evolving healthcare needs and making India a global leader in the manufacturing and innovation of medical devices. Veena Kohli, CEO, Vanguard, who previously served as the President of the Association of Diagnostics Manufacturers of India (ADMI), had the opportunity to submit recommendations regarding the challenges and growth opportunities for the Indian IVD industry to the concerned Parliamentary Standing Committees.  She mentioned, “It is very encouraging to see that several of our inputs have been included and addressed in the recently released National Medical Devices Policy, 2023. The Indian IVD industry today, is at a point of inflection from where it could be catapulted to the next orbit of growth, quite like the IT industry of India post the year 2000 and the pharma industry after the global acceptance of generic formulations, in 1985. The policy encompasses all the necessary components to achieve Vision @2047. The policy’s focus on catalysing R&D and innovation will be pivotal to the growth of the sector and will help change these dynamics.” Going forward, Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD), who has been critical of the government’s initiatives for the sector hopes for the speedy implementation of the policy. He stated, “The Parliamentary Committee had recommended a separate law, separate department, tariff correction and price control and other measures which, if implemented, will give direct benefit to consumer and industry. If the government acts like a doctor, the patient will not remain in the ICU but will step out healthy and laugh from the ward itself." Nath, however, raised the concern that consumers should reap the benefit from the policy. He goes on to add, “So far there is no restriction or capping on the MRP prices of medical devices from the government. Especially some private hospitals give the brand they want to the consumer of their own free will. Some hospitals are less concerned about the affordability needs of the patients and more concerned about their profit. They consume high MRP goods instead of low-cost options. Because of this, the manufacturer or importer in India is tied up in a system of market operating with artificially inflated MRP labelled on the device. We have been seeking a system whereby ethical manufacturers and importers can offer low-priced MRP products and still, they can sell. We have been seeking MRP of imports to be monitored and compared with imports landed prices and steps taken to control when found irrationally excessive.” The newly laid policy will catalyse India's emergence as a global hub for medical device manufacturing and innovation. This, according to Dr Sanjeev Relan, Chairman, Preventive Wear Manufacturers Association of India (PWMAI), will present a remarkable opportunity for collaboration between industry stakeholders, government bodies and healthcare professionals to collectively shape a future where advanced medical technologies are accessible, affordable, and seamlessly integrated into the healthcare ecosystem. Sharing his views, Jatin Mahajan, Secretary, Association of Diagnostic Manufacturers of India (ADMI) and MD, J Mitra & Company said, “The policy has several existing concerns. The most significant is the need for explicit provisions for training healthcare professionals and the end-users of these medical devices. This could result in mismanagement and incorrect usage, leading to potential health hazards, especially in rural and semi-urban regions with relatively low awareness and technical expertise. While stressing local manufacturing, the policy needs to provide a clear roadmap for technology transfer from global manufacturers. This lack of access to advanced technologies may hinder the production of high-end medical devices.” “Though we still have to go through the fine print, we are encouraged by the spotlight turned on R&D. While India has only 1.5 per cent of the global medical device market, it has an 8 per cent share of the MedTech R&D workforce already. This is a fertile and proven area to focus on,” said Pavan Choudary, Chairman, Medical Technology Association of India (MTaI).  While praising the much-awaited policy Sachidanand Upadhyay, MD and CEO, Lords Mark Industries said, “The Indian government's approval of the National Medical Devices Policy, 2023 is a significant move towards the growth and self-sufficiency of the country's medical devices sector. The policy is a comprehensive approach towards accelerating the growth of the medical devices sector in India.”  Expressing his thoughts Dr G S K Velu, CMD, Trivitron & Joint Coordinator IVD (Diagnostic Vertical Group) AiMed opined, “We do hope this gives the necessary impetus to reduce import dependency in the medical devices sector and make India a global medical device manufacturing destination. If implemented along with a preference for buying locally made products, I am sure the medical devices sector will grow like the pharmaceuticals industry in the next 10 to 15 years.” In the same vein, Ganesh Sabat, CEO, Sahajanand Medical Technologies stated, “The domestic industry is optimistic that together in a PPP mode, we would be able to create an ecosystem for the holistic growth of overall healthcare industry in India, make India self-sufficient and reduce import dependency to a large extent. We can expand both markets and exports, where one can hope to see exponential growth in the coming years to achieve Vision 2047." Aravind Viswanathan, CEO, Transasia Bio-Medicals pointed out that the policy will streamline the regulatory approval process for medical devices by introducing a single-window clearance system for indigenously manufactured designs and products. According to him, the move will also enhance the role of agencies such as Bureau of Indian Standards (BIS) in product manufacturing, processing, and even looking at its performance. He opined, “The need of the hour is to fast track the implementation of this policy in order to achieve the mission of self-reliance and reducing our dependency on imports.” The way forward In another recent development, the Department of Pharmaceuticals, government of India announced the scheme for “Assistance to Medical Device Clusters for Common Facilities (AMD-CF). The scheme aims to strengthen medical device clusters by providing financial assistance and strengthening and/or establishing more testing laboratories for medical devices to improve quality and sustainable growth. For Common Infrastructure Facilities (CIF) for the Medical Device (MD) clusters, the limit of support will be 70 per cent of the approved project cost or Rs 20 crore, whichever is less, as per the approval of the Scheme Steering Committee (SSC). In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs 20 crore per cluster or 90 per cent of the project cost of the CIF, whichever is less. While Medical Devices Parks, as planned clusters with shared common manufacturing and testing or warehousing and clearing facilities are  being encouraged to help reduce the capital expenditure (CAPEX) of manufacturers, it is also important to strengthen the existing manufacturing natural clusters in different parts of the country. More so, Dr Manshukh Mandaviya, Union Health Minister, who was in Tokyo on May 16 to attract investments, while emphasising the crucial role of the medical devices sector in India’s healthcare industry, urged Japanese medical device manufacturers to take the advantage of the ‘Make in India’ initiative.  Dr Mandaviya also projected a four-fold growth in the medical devices sector by 2030, from its current size of $11 billion. He stressed that India’s industry could emerge as a global leader in medical device manufacturing and innovation over the next 25 years, in line with India’s G20 Presidency aims. The policy has been announced with much fanfare and experts in this field are excited about it. With the new policy in place, the Centre aims to reduce India’s import dependence to nearly 30 per cent in the next couple of years; and become one of the top five global manufacturing hubs. However, the time frame of implementation of the policy will determine when the benefits accrued by the medical device players can ultimately be passed onto the consumers. Sanjiv Das sanjiv.das@mmactiv.com   ]]> https://biospectrumindia.com/news/22/23155/govt-to-release-pli-scheme-to-support-development-of-basic-chemicals-in-pharma.html https://biospectrumindia.com/news/22/23155/govt-to-release-pli-scheme-to-support-development-of-basic-chemicals-in-pharma.html Fri, 26 May 2023 00:00:00 +0530 "The government is planning to release a PLI scheme to support the development of basic chemicals required across the Indian pharma industry, and others such as petrochemicals, agrochemicals etc." This was stated by the Union Minister of Health and Family Welfare Dr Mansukh Mandaviya as he inaugurated the 8th International Conference on Pharma and Medical Device Sector, on 26th May, in the presence of Bhagwanth Khuba, Minister of State for Chemicals and Fertilizers; S Aparna, Secretary, Department of Pharmaceuticals, and Prof Ajay Kumar Sood, Principal Scientific Advisor to the Government of India. This conference is organised by the Department of Pharmaceuticals in association with Federation of Indian Chambers of Commerce and Industry (FICCI) for two days (26 & 27 May) to promote India as a manufacturing hub of quality medical products in the pharmaceutical and Medical Device Sector. Dr Mandaviya further called the industry to join hands with the government in advancing India's reputation and unleashing its full potential. With a clear focus on quality, affordability, and collaboration, the Minister expressed optimism for a bright future in the pharmaceutical and medical devices sectors. The event also witnessed the launch of official launch of the 'National Medical Devices Policy 2023', along with the official launch of 'Assistance to Medical Device Clusters for Common Facilities' Scheme and the 'Medical Devices Export Promotion Council'. In addition, 6 reports on Pharmaceuticals and Medical Devices sectors were unveiled by the Health Minister- Boosting the Indian Medical Devices Industry; Survey of Medical Devices Clusters; Assessment of Skill Requirement of Indian Pharmaceutical Industry; Survey of Pharma Business; Survey of novel & innovative and cost effective technologies for the root of synthesis to decrease the cost of productions of APIs which are currently being imported to reduce import dependency; Strategy for Leveraging ASEAN FTA and Trade Potential with the Middle East Countries for the Pharma Sector in India. ]]> https://biospectrumindia.com/news/22/23150/ministry-of-minority-affairs-grants-rs-45-34-cr-for-promotion-of-unani-medicine.html https://biospectrumindia.com/news/22/23150/ministry-of-minority-affairs-grants-rs-45-34-cr-for-promotion-of-unani-medicine.html Thu, 25 May 2023 00:00:00 +0530 Ministry of Ayush and Ministry of Minority Affairs, Government of India, have jointly taken a significant step to promote and develop Unani system of medicine in India. Ministry of Minority Affairs has approved a grant of Rs 45.34 crore under Pradhan Mantri Jan Vikas Karyakram (PMJVK), a centrally sponsored scheme (CSS). With support of this scheme, Unani Medicine facilities will be upgraded at Hyderabad, Chennai, Lucknow, Silchar and Bengaluru locations. Central Council for Research in Unani Medicine (CCRUM) has been sanctioned a total amount of Rs 35.52 crore and National Institute of Unani Medicine (NIUM), Bengaluru has been sanctioned Rs 9.81 crore. A centre for fundamental research in Unani Medicine at National Research Institute of Unani Medicine for Skin Disorders, Hyderabad will be established at a cost of Rs 16.05 crore. Ministry has proposed cost of Rs 8.15 crore for a preclinical laboratory facility at Regional Research Institute of Unani Medicine, Chennai, Rs 8.55 crore for a centre of Ilaj bit Tadbeer (regimenal therapy) for musculoskeletal disorders at Central Research Institute of Unani Medicine, Lucknow, and Rs 2.75 crore for a centre of Ilaj bit Tadbeer (regimenal therapy) for skin and lifestyle disorders at Regional Research Institute of Unani Medicine, Silchar. NIUM, Bengaluru will get Rs 5.55 crore for establishing a Vishram Girah for patients’ attendants and Rs 4.26 crore for a skill centre of model Unani cosmetic care, a small-scale Unani pharmacy and Unani crude drug storage. The proposals were considered by the Empowered Committee of the Ministry of Minority Affairs in its meeting held on March 02, 2023 and Rs 4.86 crore has already been released to the CCRUM as the first instalment (25%) of total sanctioned cost of its three projects at Chennai, Lucknow and Silchar. The grant of CCRUM project for Hyderabad and the projects of NIUM, Bengaluru would be released once their detailed project reports are approved and other technicalities finalised.    ]]> https://biospectrumindia.com/news/22/23131/icmr-inks-moa-with-national-cancer-grid-to-revolutionise-cancer-care.html https://biospectrumindia.com/news/22/23131/icmr-inks-moa-with-national-cancer-grid-to-revolutionise-cancer-care.html Tue, 23 May 2023 00:00:00 +0530 Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, has signed a Memorandum of Agreement (MoA) with National Cancer Grid (NCG), an initiative of the Government of India through the Department of Atomic Energy and its grant-in-aid institution, the Tata Memorial Centre. The objective of the MoA is exclusively for clinical trials, focusing on the development of novel affordable therapies for India-specific cancers and cancers common in India. The agreement covers joint funding for multicentric, multidisciplinary, interventional trials for common/unique cancers. The National Cancer Grid (NCG) has been established to create a network of cancer centres, research institutes, patient groups and charitable institutions across India with the objective of developing uniform standards of patient care for prevention, diagnosis, and treatment of cancer; providing specialised training and education in oncology and facilitating collaborative basic, translational and clinical research in cancer. NCG today has over 270 hospitals in its network across India. ]]> https://biospectrumindia.com/news/22/23106/govt-launches-comprehensive-ayush-health-and-education-learning-management-system.html https://biospectrumindia.com/news/22/23106/govt-launches-comprehensive-ayush-health-and-education-learning-management-system.html Thu, 18 May 2023 00:00:00 +0530 Union Minister of Health and Family Welfare Dr Mansukh Mandaviya delivered the inaugural address at the National Ayush Mission Conclave organised by Ministry of Ayush, on 18 May. The event witnessed the launch of Information and Communication Technology initiatives namely AHMIS (Ayush Health Management Information System) and eLMS (Education Learning Management System) by Dr Mansukh Mandaviya, Union Health Minister and Sarbananda Sonowal, Union Ayush Minister in the presence of Dr Munjpara Mahendrabhai, Minister of State, Ayush. The two days conclave (18th and 19th May 2023) will pave way for better coordination among stakeholders and strengthen Ayush Health Wellness centers (AHWCs) functioning. During the conclave, subject experts from participating states will deliberate on various aspects of National Ayush Mission (NAM), focused on enhanced efficiency in budget absorption under NAM and institutionalisation for improvised execution of the scheme, enabling better supply of medicines to Ayush Health Facilities, capacity building for Ayush and up-gradation of Ayush Health Wellness centers (AHWCs), strengthening the education ecosystem in Ayush to strengthen Public Health and technological integration for research and quality assurance in Ayush public healthcare. ]]> https://biospectrumindia.com/news/22/23100/government-releases-annual-capacity-building-plan-for-ministry-of-health-and-family-welfare.html https://biospectrumindia.com/news/22/23100/government-releases-annual-capacity-building-plan-for-ministry-of-health-and-family-welfare.html Wed, 17 May 2023 00:00:00 +0530 “Capacity Building Plans act as ‘Highways’ for focused output by competent workforce, and provide a ‘work culture’ to the organisation where individuals with streamlined efforts work with as team with shared goals and vision”. This was stated by Union Minister of Health and Family Welfare Dr Mansukh Mandaviya as he launched the Annual Capacity Building Plan for capacity building of civil servants of the Ministry of Health and Family Welfare, in the presence of Dr Bharati Pravin Pawar, Union Minister of State for Health and Family Welfare (MoHFW) who joined the meeting virtually. The Annual Capacity Building Plan (ACBP) is a comprehensive strategic document envisioned to assist the development in enhancement of capacities of individuals, and of Ministry/ Department/ Organisations (MDOs). The plan has been developed by the Capacity Building Commission in close coordination and consultation with the Mission Karmayogi Cell of the Health Ministry, all divisions in the department and subsequent to a detailed Training Needs Analysis (TNA) for MoHFW. Rajesh Bhushan, Secretary, Health Ministry laid out the roadmap for the Ministry and urged the training institutions to assume a leadership role in the roll out of the plan. He  highlighted that the vision behind this initiative is to enhance the skill and capacity building of officials in accordance with the requirements of the different departments of the Ministry.  ]]> https://biospectrumindia.com/news/22/23086/government-announces-scheme-to-assist-medical-device-clusters.html https://biospectrumindia.com/news/22/23086/government-announces-scheme-to-assist-medical-device-clusters.html Mon, 15 May 2023 00:00:00 +0530 Department of Pharmaceuticals (DoP), under Ministry of Chemicals & Fertilizers, Government of India, has announced the scheme for “Assistance to Medical Device Clusters for Common Facilities (AMD-CF)”. This scheme aims to strengthen Medical Device clusters by providing financial assistance and to strengthen and / or establish more testing laboratories for Medical Devices to improve quality and sustainable growth. For Common Infrastructure Facilities (CIF) for the Medical Device (MD) clusters, the limit of support will be 70% of the approved project cost or Rs 20 crore, whichever is less, as per the approval of Scheme Steering Committee (SSC). In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs 20 crore per cluster or 90% of the project costof the CIF, whichever is less. While Medical Devices Parks as planned clusters with shared common manufacturing & testing or warehousing & clearing facilities were being encouraged to help reduce the CAPEX (capital expenditure) of manufacturers, it is also important to strengthen the existing manufacturing natural clusters that existed in different parts of the country. "FFP2 Masks (commonly referred to as N95 masks) needs a test laboratory that can cost a few lacs for each factory but in Covid times manufacturers were allowed sharing of these facilities until they put up their own. Now hopefully they can explore this avenue and not be burdened by cost of lab as they struggle to survive in a falling demand market”, said Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD). ]]> https://biospectrumindia.com/news/22/23075/icmr-inks-moa-with-ayush-ministry-for-health-research-in-integrated-medicine.html https://biospectrumindia.com/news/22/23075/icmr-inks-moa-with-ayush-ministry-for-health-research-in-integrated-medicine.html Thu, 11 May 2023 00:00:00 +0530 A Memorandum of Agreement (MoA) has been signed between Indian Council of Medical Research (ICMR) under the Health Ministry and Ministry of AYUSH, for collaboration and cooperation in health research in the field of Integrated Medicine.  The MoA envisages cooperation and collaboration between Ministry of AYUSH and ICMR for exploring the areas of convergence and synergy between the two organiSations for integrative health research and strengthening research capacity. The agreement also envisages exploring possibility with Ayush Ministry and ICMR to work on public health research initiatives for addressing diseases of national importance. Efforts to conduct high-quality clinical trials jointly on identified areas/disease conditions of national importance with promising therapies of Ayush system to generate evidence for wider acceptance is also part of the agreement. A joint working group shall be created between Ministry of AYUSH and ICMR which will meet quarterly for exploring further areas of collaboration and work on deliverables. Both institutions shall formulate and implement joint research projects and programmes and allow joint supervision of the said activities as well as design and conduct conferences, workshops, seminars jointly with active participation of researchers interested in the field of Integrative Healthcare.   ]]> https://biospectrumindia.com/news/22/23069/health-ministry-introduces-saksham-learning-management-information-system.html https://biospectrumindia.com/news/22/23069/health-ministry-introduces-saksham-learning-management-information-system.html Wed, 10 May 2023 00:00:00 +0530 Rajesh Bhushan, Union Health Secretary has launched the SAKSHAM (Stimulating Advanced Knowledge for Sustainable Health Management), a Learning Management Information System (LMIS). This digital learning platform has been developed by the National Institute of Health & Family Welfare (NIHFW), New Delhi.  SAKSHAM is a dedicated and unified platform for providing online training and medical education to all health professionals in the country. This digital learning platform will ensure inclusive capacity building of health professionals from primary health centres located in rural and remote areas all the way up to tertiary care and corporate hospitals in metropolitan cities. Currently SAKSHAM: LMIS is hosting more than 200 public health and 100 clinical courses through online mode. Health professionals can register themselves for these courses on the portal and get the certification after undergoing requisite training and qualifying the required assessment criteria. SAKSHAM is an initiative of the Ministry of Health and Family Welfare (MoHFW), Government of India which provides all health-related training programmes to healthcare professionals of the country in digital mode.   ]]> https://biospectrumindia.com/news/22/23063/health-ministry-releases-standard-treatment-guidelines-for-sickle-cell-anaemia-disease.html https://biospectrumindia.com/news/22/23063/health-ministry-releases-standard-treatment-guidelines-for-sickle-cell-anaemia-disease.html Mon, 08 May 2023 00:00:00 +0530 Dr Bharati Pravin Pawar, Union Minister of State for Health and Family Welfare, released the Standard Treatment Workflow for Sickle Cell Disease on the occasion of World Thalassemia Day, on 8th May. This has been developed by the Indian Council of Medical Research (ICMR).  The Union Minister further highlighted the need to take advantage of various initiatives of the Union Government for treatment of diseases like sickle cell anaemia such as the e-Raktkosh portal for blood transfusion requirements and the network of over 1.5 lakh Health and Wellness Centres for treatment and diagnostic care. She also launched the third phase of Thalassemia Bal Sewa Yojana (TBSY) of the Health Ministry which is being supported by Coal India Limited (CIL) as part of their Corporate Social Responsibility (CSR) initiative to commemorate World Thalassemia Day, on 8th May. She also launched the Thalassemia Bal Sewa Yojana Portal.   The third phase of the Thalassemia Bal Sewa Yojana will continue to provide financial assistance for a package cost of 10 lakhs per Hematopoietic Stem Cell Transplant (HSCT), directly transferred from CIL to the institutions performing HSCT. The programme will benefit underprivileged thalassemia patients and those with aplastic anemia, which is an irreversible condition that can be life-threatening without treatment. The programme has empaneled 10 reputed hospitals across India, including AIIMS, New Delhi; CMC Vellore; Kokilaben Dhirubhai Ambani Hospital, Mumbai; MCGM Hospital, Mumbai; PGIMER, Chandigarh; Rajiv Gandhi Cancer Institute, New Delhi; SGPGI, Lucknow; Narayana Hrudayalaya, Bangalore; CMC, Ludhiana and Tata Medical Centre, Kolkata among others. ]]> https://biospectrumindia.com/news/22/23050/dcgi-approves-astrazenecas-drug-for-metastatic-breast-cancer-treatment.html https://biospectrumindia.com/news/22/23050/dcgi-approves-astrazenecas-drug-for-metastatic-breast-cancer-treatment.html Thu, 04 May 2023 00:00:00 +0530 AstraZeneca Pharma India has received approval from the Drug Controller General of India (DCGI) for the cancer drug trastuzumab deruxtecan for the treatment of metastatic breast cancer. Trastuzumab deruxtecan is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. AstraZeneca has received import and marketing permission in Form CT-20 from the regulator, and the therapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen. The India approval is based on a global, head-to-head, randomised, open label, registrational Phase III trial DESTINY Breast 03. Globally, trastuzumab deruxtecan is approved in more than 40 countries, including the US, for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of multiple tumours including breast, gastric, lung and colorectal cancers, and is one of the biomarkers expressed in breast cancer tumours. Dr. Sanjeev Panchal, Country President and Managing Director, AstraZeneca India, said, “India’s approval of trastuzumab deruxtecan marks a significant clinical advancement allowing us to help more patients across the HER2 spectrum. It also supports our ambition to evolve the way breast cancer is classified and treated in the country, to ultimately improve patient outcomes."   ]]> https://biospectrumindia.com/news/22/23043/govt-asks-industry-to-pitch-in-higher-rd-budget-and-support-startups.html https://biospectrumindia.com/news/22/23043/govt-asks-industry-to-pitch-in-higher-rd-budget-and-support-startups.html Tue, 02 May 2023 00:00:00 +0530 Government said that it is mulling over making Indian Patent Act more simplified and research friendly for product-oriented results. Addressing the Global Science, Research and Innovation Summit organised by the Confederation of Indian Industry (CII) titled “Fostering Science, Research and Innovation Partnerships’ under the aegis of the India’s G20 Presidency at the Indian Institute of Technology Delhi (IIT-D), Dr Akhilesh Gupta, Senior Adviser at the Department of Science and Technology (DST), Government of India said, while India grants average of 23,000 patents per annum, despite having over 1000 Universities, it is over 5 lakhs in China. He said, India lacks the culture of Patents filing and taking it to its logical conclusion. Dr Gupta, who is also Secretary of the Science and Engineering Research Board (SERB) said that time duration of patents filing and grant of patents is 3 years in India, while the global average is two years. Referring to around 0.69 percent of budget being spent on R&D in India, Dr Gupta said, private sector must pitch in with higher research allocation to match and support government for a win-win proposition. Dr Parvinder Maini, Scientific Secretary in the Office of Principal Scientific Adviser to the Government of India said, "out of 90,000 startups in India, only 12,000 are technology-based and also only about 3,000 of them are deep tech startups." She said, unless industry will not lend funding support to innovative and bright ideas, India will miss the bus, which is now on its way to full bloom. Prof K.P Sudheer, Ex-Officio Principal Secretary, S&T Department, Government of Kerala in his address said that 4 Science Parks will be established in Kerala in coming days with participation from Industry and startups. He also informed that Kerala is the only state in the country with a separate R&D budget document and this year the allocation was Rs 3500 crore. Prof Rangan Banerjee, Director, IIT-D in his address announced that IIT-D will start M-tech in Robotics this year and appealed to Industry to support this mission. He said, CII should work with Industry to sponsor at least 300 to 400 PhD through a new model to develop market ready products.   ]]> https://biospectrumindia.com/news/22/23020/india-uk-call-for-enhanced-science-technology-cooperation.html https://biospectrumindia.com/news/22/23020/india-uk-call-for-enhanced-science-technology-cooperation.html Thu, 27 Apr 2023 00:00:00 +0530 India and United Kingdom (UK) will together jointly create India-UK "NET Zero" Innovation Virtual Centre. Announcing this while chairing the India-UK Science & Innovation Council meeting in presence of his British counterpart, UK Minister George Freeman, Union Minister of State (Independent Charge) Science & Technology Dr Jitendra Singh that India is fast moving to become an economic powerhouse, driven by its extraordinary technological and innovative capabilities which the whole world has begun to acknowledge, particularly after the COVID-19 vaccine success story. The two leaders called for enhanced Science & Technology cooperation between India and the United Kingdom. UK has emerged as India’s second largest international research and innovation partner. The India-UK Science & Technology (S&T) collaboration has been growing at a rapid pace and the joint research programme has gone from an almost zero base to close to £300-400 million now. Both the Ministers appreciated the proposal to create an India-UK "NET Zero" Innovation Virtual Centre which will provide a platform to bring stakeholders from both countries together to work in some of the focus areas including Decarbonization of manufacturing process & transport systems and Green Hydrogen as renewable source. Both the leaders called for newer collaborations for joint R&D projects between Biotechnology and Biological Sciences Research Council, part of UK Research and Innovation (BBSRC)- Department of Biotechnology, Government of India (DBT) in the area of Farmed Animal disease and Health. ]]> https://biospectrumindia.com/news/22/23012/cabinet-approves-national-medical-devices-policy-2023.html https://biospectrumindia.com/news/22/23012/cabinet-approves-national-medical-devices-policy-2023.html Wed, 26 Apr 2023 00:00:00 +0530 The Union Cabinet, chaired by Prime Minister Narendra Modi, has approved the National Medical Devices Policy 2023. The policy is expected to facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality and innovation. It lays down a roadmap for accelerated growth of the medical devices sector to achieve the following missions viz, Access & Universality, Affordability, Quality, Patient Centred & Quality Care, Preventive & Promotive Health, Security, Research and Innovation and Skilled manpower. The medical devices sector will be facilitated and guided through a set of strategies that will be cover six broad areas of policy interventions: Regulatory Streamlining- in order to enhance ease of doing research and business and further to balance patient safety with product innovation measures Enabling Infrastructure- The establishment and strengthening of large medical device parks, clusters equipped with world class common infrastructure facilities in proximity to economic zones would be pursued with the State Governments and Industry for better convergence and backward integration with medical device Industry Facilitating R&D and Innovation- The policy envisages to promote Research & Development in India and complement the Department’s proposed National Policy on R&D and Innovation in the Pharma- MedTech Sector in India.  Attracting Investments in the Sector- Along with recent schemes and interventions  Human Resources Development- To support dedicated multidisciplinary courses for medical devices in existing institutions to ensure availability of skilled manpower; To develop partnerships with foreign academic/industry organisations  Brand Positioning and Awareness Creation: Creation of a dedicated Export Promotion Council for the sector under the Department which will be an enabler to deal with various market access issues. ]]> https://biospectrumindia.com/news/22/22988/national-covid-19-vaccination-programme-receives-excellence-award-by-pm.html https://biospectrumindia.com/news/22/22988/national-covid-19-vaccination-programme-receives-excellence-award-by-pm.html Fri, 21 Apr 2023 00:00:00 +0530 The National COVID-19 Vaccination Programme of the Union Health Ministry received the Prime Minister’s Award for Excellence in Public Administration 2022 under the innovation category. Rajesh Bhushan, Secretary, Ministry of Health and Family Welfare Ministry received the award from Prime Minister (PM) Narendra Modi at a function organized on the occasion of 16th Civil Services Day at Vigyan Bhawan, New Delhi. A robust monitoring system based on consultative approach was established through the State Steering Committee, State Task Force, District Task Force, Block/Urban Task Force with a two-way feedback mechanism to ensure swift mid-course corrective measures.  Development of Co-WIN (Winning over COVID) platform for facilitating a smooth vaccination roll-out was critical in the success of the programme. The Co-WIN platform was a key factor in enabling India to achieve multiple milestones in vaccination which includes- 221 crore (2.21 billion) vaccine doses administered across India and tracked digitally. This is 17% of the total COVID-19 vaccine doses administered across the world i.e., 13.34 billion. ]]> https://biospectrumindia.com/news/22/22968/ministry-of-ayush-to-ensure-benchmarking-of-artificial-intelligence-in-traditional-medicine.html https://biospectrumindia.com/news/22/22968/ministry-of-ayush-to-ensure-benchmarking-of-artificial-intelligence-in-traditional-medicine.html Tue, 18 Apr 2023 00:00:00 +0530 The second day of 2nd Health Working Group meeting under G20 India Presidency saw an important brainstorming session on citizen centric health delivery ecosystem for universal health coverage leveraging digital health and innovation, on 18th April 2023. Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush in his inaugural address in the side event emphasised on an integrative holistic healthcare model of service delivery through comprehensive IT backbone for Traditional Medicine “Ayush Grid” and by ensuring the benchmarking of artificial intelligence (AI) in Traditional Medicine with the guidance and support of UN bodies. Vaidya Kotecha further said that there is need to advocate the use of digital tools for not only the efficiency and outcome of healthcare system but also to maintain the medical records, exchange information and extrapolate the effectiveness of various modalities of healthcare including; but not limited to pharmaco-therapeutic interventions, traditional medicine based approaches and other innovations. He said that the upcoming World Health Organisation (WHO) - Global Centre for Traditional Medicine in India has one of the mandates to work on data analytics and technology in Traditional medicine. ]]> https://biospectrumindia.com/news/22/22959/second-g20-health-working-group-meeting-in-goa-focuses-on-future-health-emergencies.html https://biospectrumindia.com/news/22/22959/second-g20-health-working-group-meeting-in-goa-focuses-on-future-health-emergencies.html Mon, 17 Apr 2023 00:00:00 +0530 The second G20 Health Working Group meeting commenced on 17th April 2023 in Goa. Dr. Bharati Pravin Pawar, Union Minister of State for Health and Family Welfare, delivered the keynote address, emphasising the need for developing consensus on responding to future health emergency management, network of R&D and manufacturing of vaccines and therapeutics, besides the global medical countermeasure coordination platform. Highlighting India’s progress in promoting Health and Wellness tourism, Shripad Naik, Union Minister of State for Tourism and Ports & Shipping and Waterways, noted that the country witnessed more than 1.4 million medical tourists in the past one year, making it one of the top destinations for medical tourism. Further, Union Health Secretary, Rajesh Bhushan, stated that India welcomes the first call for proposal by Pandemic Fund focused on surveillance, lab systems and strengthening public health workforce. He further emphasised the need for G20 member states to work for interweaving the multiple health initiatives under various multilateral forums like G7, World Bank, Pandemic Fund etc in order to create an agile and fit-for-purpose global health architecture. The Pandemic Fund opened its first Call for Proposals on March 3, 2023 and is inviting interested Eligible Countries, Regional Entities and Implementing Entities to develop full proposals for potential projects to be supported by this initial funding. The Pandemic Fund Governing Board has approved an envelope of $300 million in financing for its first round of funding to help developing countries better prepare for and respond to future pandemics. ]]> https://biospectrumindia.com/news/22/22950/assam-advanced-health-care-innovation-institute-to-be-built-at-cost-of-rs-546-cr.html https://biospectrumindia.com/news/22/22950/assam-advanced-health-care-innovation-institute-to-be-built-at-cost-of-rs-546-cr.html Fri, 14 Apr 2023 14:25:00 +0530 Prime Minister (PM) Narendra Modi laid the foundation stone and dedicated to the nation various projects worth more than Rs 3,400 crore in Guwahati, Assam, on 14th April. The PM dedicated All India Institute of Medical Sciences (AIIMS) Guwahati and three other medical colleges to the nation. He also laid the foundation stone of Assam Advanced Health Care Innovation Institute (AAHII) and launched ‘Aapke Dwar Ayushman’ campaign by distributing Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) cards to eligible beneficiaries. The operationalisation of AIIMS, Guwahati will mark a momentous occasion for the state of Assam and the entire North-East region. This is also a testimony of the Prime Minister’s commitment to strengthening health infrastructure across the country. The foundation stone of this hospital was also laid by the Prime Minister in May 2017. Built at a cost of more than Rs 1120 crore, AIIMS Guwahati is a state-of-the-art hospital with a capacity of 750 beds including 30 AYUSH beds. This hospital will have an annual intake capacity of 100 MBBS students every year along with providing world-class health facilities to the people of the Northeast. The PM also dedicated to the nation three medical colleges viz Nalbari Medical College, Nalbari; Nagaon Medical College, Nagaon; and Kokrajhar Medical College, Kokrajhar, built at a cost of about Rs 615 crore, Rs 600 crore and Rs 535 crore respectively. Each medical college has an attached 500-bed teaching hospital with OPD/IPD services including emergency services, ICU facilities, OT and diagnostic facilities etc.  Each medical college will have an annual intake capacity of 100 MBBS students.The PM remarked that the health infrastructure of Assam and the North East has found new strength as the Northeast gets its first AIIMS and the state of Assam gets three new medical colleges. He underlined that the foundation stone for a 500-bed super speciality hospital has also been laid for advanced research in collaboration with Indian Institute of Technology (IIT) Guwahati.  ]]> https://biospectrumindia.com/news/22/22947/stakeholders-get-together-to-develop-comprehensive-malaria-elimination-strategy-for-assam.html https://biospectrumindia.com/news/22/22947/stakeholders-get-together-to-develop-comprehensive-malaria-elimination-strategy-for-assam.html Thu, 13 Apr 2023 00:00:00 +0530 Malaria No More (MNM) in collaboration with the National Vector Borne Disease Control Programme (NVBDCP), Assam recently organised a workshop to deliberate on malaria elimination strategies for the state.  The workshop engaged with key health officers, both from the Regional Office of Health and Family Welfare and the State Health Department of Assam. The goal of the workshop was to develop a state-specific malaria elimination strategy, in collaboration with the state government, and help reduce the burden of the disease in Assam while strengthening the efforts towards malaria elimination.  The workshop took a holistic approach in its execution and focused on a range of themes linked to malaria elimination. These included assessing the preparedness for elimination in the state, re-aligning strategies from control to elimination, the need for improved surveillance and case management, the use of innovative tools and technologies, integration of improved data collection and management tools, and the importance of community engagement and social behaviour change interventions.  Addressing the workshop, Dr M.S. Lakshmi Priya, IAS, Mission Director, National Health Mission Assam said “To achieve malaria elimination in the state of Assam, surveillance and treatment compliance need to be robust. The most important person for any health programme is the last patient suffering with the disease, identifying and treating them is critical to achieve elimination."   ]]> https://biospectrumindia.com/news/22/22930/-ministry-of-ayush-kerala-govt-to-hold-trial-of-arsenicum-album-for-covid-19-treatment.html https://biospectrumindia.com/news/22/22930/-ministry-of-ayush-kerala-govt-to-hold-trial-of-arsenicum-album-for-covid-19-treatment.html Mon, 10 Apr 2023 00:00:00 +0530 An agreement was recently exchanged between Central Council for Research in Homoeopathy (CCRH) under Ministry of Ayush, and the Department of Homoeopathy, Government of Kerala for conducting clinical trial on immunological responses of Arsenicum album (AA) in COVID-19. During the early part of the COVID-19 pandemic, Ministry of Ayush had advised Arsenicum album 30C, as a prophylactic to prevent COVID-19. However, some cases of acute liver injury, leading to death in one patient with underlying non-alcoholic steatohepatitis (NASH) cirrhosis, after consumption of the homeopathic remedy AA30 for COVID-19 prevention were reported. On the other hand, some studies had revealed that the homeopathic medicine Arsenicum album 30C was associated with a decrease in the incidence and provided some protection against COVID-19 as compared to non-treatment.  AA 30 is apparently used for the treatment of respiratory problems which include throat infections, sore throat, and cough leading to breathing difficulties. It is also used to boost immunity against infections. According to CCRH, Arsenicum album 30 has also been advised for the prevention of influenza-like infections.  ]]> https://biospectrumindia.com/news/22/22913/25000-health-facilities-across-india-undergoing-transformation-to-address-climate-issues.html https://biospectrumindia.com/news/22/22913/25000-health-facilities-across-india-undergoing-transformation-to-address-climate-issues.html Sat, 08 Apr 2023 00:00:00 +0530 In a significant step towards transforming the public health infrastructure for improved sustainability, SELCO Foundation and IKEA Foundation, in partnership with India’s Ministry of Health and Family Welfare (MoHFW) and various State Health Missions, have launched a groundbreaking initiative ‘Energy for Health’. The programme recognises climate adaptation and mitigation at the centre to all efforts to upgrade the public health facilities across the world. The first-of-a-kind initiative will bring solar energy solutions with efficient medical and electrical equipment to 25,000 healthcare facilities in 12 states by 2026. Across the 12 states under this programme, there is a diversity in terms of topography, socio-economic vulnerabilities, disease burden and climate. This diversity across selected geographies will contribute to this programme serving as a showcase globally- innovating on approaches, models and processes relevant for similar contexts in other parts of the world. The initiative aims to reach over 170 million people across the 12 states and improve working conditions for over 160,000 front line health staff at these health facilities.  ]]> https://biospectrumindia.com/news/22/22903/651-essential-drugs-turn-6-73-cheaper-from-april-1-.html https://biospectrumindia.com/news/22/22903/651-essential-drugs-turn-6-73-cheaper-from-april-1-.html Wed, 05 Apr 2023 00:00:00 +0530 Following the National Pharmaceutical Pricing Authority (NPPA) price revision of 651 essential drugs out of the over 870 scheduled drugs under the National List of Essential Medicines (NLEM), the industry is in a tizzy and has voiced concern that the price revision in 15 to 20  per cent essential drugs has been done without prior intimation or consultation.   Highlighting the fact that a draft Drug Prices Control Order (DPCO) calculation sheet is being circulated among the pharma companies for their suggestions before issuing the price revision list, the national drug pricing regulator could have been done it in a consultative manner, an industry official said citing that due to NPPA sudden price revision exercise, the price of 651 essential drugs has drastically come down by 6.73 per cent on average from April 1, 2023 onwards. The cost of these essential drugs had already come down by 16.62 per cent because of the capping of ceiling prices. The NPPA revised the list and prices of essential medicines in November 2022 and the work of revising the applicable ceiling price of such notified drugs had been initiated by the NPPA under DPCO, 2013. The Union Health Ministry, while justifying the same, stated that even if the prices were to go up by 12.12 per cent this year, the capping would help offset the hike. “A company can increase the price of medicines with effect from April 1, 2023, to the extent of 12.12 per cent of the valid ceiling price of 651 essential medicines linked to Wholesale Price Index (WPI). But even if the company were to increase the price in full, an average reduction of 6.73 per cent is estimated,” the Union Health Ministry tweeted responding to a tweet about Essential Medicine Price Rise. The World Health Organisation, in its note on Essential Medicines in Southeast Asia, said that an estimated 40 per cent of health budgets in low- and middle-income countries were spent on medicines, with much of the cost borne out-of-pocket by patients.   Bhagwati Prasad   ]]> https://biospectrumindia.com/news/22/22875/govt-announces-customs-duty-full-exemption-for-all-drugs-used-in-rare-diseases-treatment-.html https://biospectrumindia.com/news/22/22875/govt-announces-customs-duty-full-exemption-for-all-drugs-used-in-rare-diseases-treatment-.html Thu, 30 Mar 2023 00:00:00 +0530 The Central Government has given full exemption from basic customs duty on all drugs and food for special medical purposes imported for personal use for treatment of all rare diseases listed under the National Policy for Rare Diseases 2021 through a general exemption notification. In order to avail this exemption, the individual importer has to produce a certificate from Central or State Director Health Servicesor District Medical Officer/Civil Surgeon of the district. Drugs/Medicines generally attract basic customs duty of 10%, while some categories of lifesaving drugs/vaccines attract concessional rate of 5% or Nil. While exemptions have already been provided to specified drugs for treatment of Spinal Muscular Atrophy or Duchenne Muscular Dystrophy, the government has been receiving many representations  seeking  customs duty relief for drugs and medicines used in treatment of  other Rare Diseases. Drugs or Special Foods required for the treatment of these diseases are expensive and need to be imported. It is estimated that for a child weighing 10 kg, the annual cost of treatment for some rare diseases, may vary from Rs 10 lakh to more than Rs 1 crore per year with treatment being lifelong and drug dose and cost, increasing with age and weight. This exemption will result in substantial cost savings and provide much needed relief to the patients.  The government has also fully exempted Pembrolizumab (Keytruda) used in treatment of various cancers from basic customs duty. ]]> https://biospectrumindia.com/news/22/22859/dbt-to-play-critical-role-in-tb-elimination-by-mapping-drug-resistance.html https://biospectrumindia.com/news/22/22859/dbt-to-play-critical-role-in-tb-elimination-by-mapping-drug-resistance.html Mon, 27 Mar 2023 00:00:00 +0530 Union Minister of State (Independent Charge) Science & Technology Dr Jitendra Singh has announced integrated strategy to achieve 'TB Mukt Bharat' and said that the Department of Biotechnology (DBT) is going to play an important  part in this integrated holistic healthcare approach against elimination of Tuberculosis (TB), in keeping with Prime Minister Narendra Modi’s commitment of ‘TB Mukt Bharat’ by 2025. The Minister declared commencement of the pilot phase of Indian Tuberculosis Genomic Surveillance Consortium (InTGS) with successful completion of whole genome sequencing (WGS) of 182 strains of Mycobacterium tuberculosis (Mtb) isolated from TB patients and development of a novel blood bag technology at DBT-InStem, Bengaluru.  Presentations on new initiatives on improving Tuberculosis outcomes – a) AYUSH interventions to improve TB patient quality-of-life (QOL) b) Mapping drug resistance through genomics & artificial intelligence (AI) and novel blood bag technology to enhance quality and shelf life of stored blood, were made while Dr Jitendra Singh was interacting with the press on Bio-Next-Tech Innovations. Indian Tuberculosis Genomic Surveillance Consortium (InTGS), one of the key components of the programme, is a joint initiative between the Ministry of Science & Technology and the Ministry of Health & Family Welfare, led by the Department of Biotechnology. The aim is to perform WGS of 32500 strains of TB. Dr Rajesh S. Gokhale, Secretary, Department of Biotechnology stated that InTGS is modelled on the lines of the highly successful Indian SARS-CoV-2 Genomics Consortium (INSACOG). A Memorandum of Understanding (MoU) signed between the Ministry of AYUSH and DBT, conducting high impact research studies on Ayurveda intervention as adjuvant to Anti TB therapy (ATT) for improving quality of life, managing cachexia, bio-enhancing of ATT and hepato-protection is being planned. ]]> https://biospectrumindia.com/news/22/22844/ministry-of-ayush-and-ministry-of-defence-strengthen-ties-for-providing-ayush-health-services.html https://biospectrumindia.com/news/22/22844/ministry-of-ayush-and-ministry-of-defence-strengthen-ties-for-providing-ayush-health-services.html Fri, 24 Mar 2023 00:00:00 +0530 Ministry of Ayush and Department of Ex-servicemen Welfare/Ex-servicemen Contributory Health Scheme (ECHS), Ministry of Defence have signed Memorandum of Understanding to integrate Ayurveda in ECHS Polyclinics as an OPD service for five years period. These will be established at 10 polyclinics based at Ambala, Mysore, Ranchi, Nagpur, Bhopal, Bhubaneshwar, Chennai, Meerut, Danapur, and Allepey (Alappuzha). Ayurveda centres are already in place in 37 cantonment Hospitals, 12 military hospitals of AFMC and Ayurveda OPD in AH R&R, AF Hospital Hindan and five ECHS polyclinics. The MoU was signed on behalf of Ministry of Ayush by Dr Manoj Nesari, Adviser (Ayurveda), Ministry of Ayush and by Maj Gen N R Indurkar, MD, Ex-servicemen Contributory Health Scheme in the presence of Pramod Kumar Pathak, Special Secretary, Ministry of Ayush, Brig Jitendra Singh, ECHS, Col AC Nishil, Director (Medical) and other officials of Ayush Ministry. According to this MoU, Ayurveda OPD will be established in 10 ECHS Polyclinic/Dispensaries in various regions of India to cover all ECHS members on voluntary basis. Ministry will provide technical guidance from time to time and will empanel Ayurveda Doctors and Pharmacists for their engagement and provide list of essential Ayurveda medicines and any other technical support as may be required. Both ministries have agreed to form a joint working group (JWG) comprising representatives from Ministry of Ayush and Department of Ex servicemen Welfare/ECHS, Ministry of Defence to take forward the proposal of establishing OPDs as per the MoU.   ]]> https://biospectrumindia.com/news/22/22845/icmr-updates-ethical-guidelines-for-application-of-ai-in-biomedical-research-and-healthcare.html https://biospectrumindia.com/news/22/22845/icmr-updates-ethical-guidelines-for-application-of-ai-in-biomedical-research-and-healthcare.html Fri, 24 Mar 2023 00:00:00 +0530 The Indian Council of Medical Research (ICMR) has released “Ethical Guidelines for Application of Artificial Intelligence in Biomedical Research and Healthcare, 2023” to ensure ethical conduct and address emerging ethical challenges in the field of Artificial Intelligence (AI) in biomedical research and healthcare. These guidelines are also meant to provide a framework for ethical decision-making in medical AI during the development, deployment, and adoption of AI-based solutions. The guidelines are intended for all stakeholders involved in research on AI in biomedical research and healthcare, including creators, developers, researchers, clinicians, ethics committees, institutions, sponsors, and funding organisations. The guidelines include sections on ethical principles, guiding principles for stakeholders, an ethics review process, governance of AI use, and informed consent. They have been developed through extensive discussions with experts and ethicists. The guidelines are a living document and will be updated as ethics in AI evolve. "The adoption of AI technology in healthcare is growing in India. However, AI as data-driven technology has many potential ethical challenges which include algorithmic transparency and explainability, clarity on liability, accountability and oversight, bias and discrimination", said Dr Rajiv Bahl, Director General, ICMR. ICMR has formulated ethical guidance documents from time to time for promoting ethical and high quality research in India. The most recent version of ICMR’s National Ethical Guidelines for Biomedical and Health Research involving human participants, was released in 2017. ]]> https://biospectrumindia.com/news/22/22832/health-ministry-to-develop-strategic-framework-and-roadmap-for-dengue-control-.html https://biospectrumindia.com/news/22/22832/health-ministry-to-develop-strategic-framework-and-roadmap-for-dengue-control-.html Wed, 22 Mar 2023 00:00:00 +0530 Union Health Secretary, Rajesh Bhushan inaugurated a two-day technical symposium to develop a strategic framework and roadmap for dengue control in India. The purpose of this symposium being organised by the National Center for Vector Borne Diseases Control (NCVBDC), Ministry of Health and Family Welfare (MoHFW) is to bring together identified ministries, states, govt institutions and development partners under a common platform to develop strategic framework for dengue control and envision a country roadmap with the objective of maximising efficiency through convergence of efforts across multiple dimensions. Addressing the gathering, Bhushan emphasised on the importance of timely detection and reporting of dengue cases for effective management and control. He also suggested for dengue to be incorporated under the MoHFW’s Integrated Health Information Platform where 33 diseases are already covered. The Union Secretary emphasised on inter-sectoral convergence and continuous effort from all stakeholders. He urged all states to initiate a plan of action by the end of the two-day brainstorming. A future roadmap will be developed involving the subject experts with one-platform approach with robust strategy for dengue control in India. ]]> https://biospectrumindia.com/news/22/22802/manufacturing-of-critical-drug-for-radiological-nuclear-emergencies-gets-dcgi-approval.html https://biospectrumindia.com/news/22/22802/manufacturing-of-critical-drug-for-radiological-nuclear-emergencies-gets-dcgi-approval.html Tue, 14 Mar 2023 00:00:00 +0530 Manufacturing and marketing licenses for the commercial use of Prussian blue insoluble formulations, developed under the Technology Development Fund (TDF) scheme, have been granted to Scott-Edil Pharmacia, Baddi, Himachal Pradesh and Skanttr Lifescience LLP, Ahmedabad, Gujarat by Drugs Controller General of India (DCGI). The drug has been developed by the industry based on the technology of Institute of Nuclear Medicine & Allied Sciences (INMAS), Delhi, a laboratory of Defence Research & Development Organisation (DRDO). The drug will be available under the trade name of Pru-DecorpT and PruDecorp-MG. The formulations are used for decontamination of Cesium & Thallium and its Active Pharmaceutical Ingredient (API). It is one of the critical medicines listed by the World Health Organisation (WHO) for radiological and nuclear emergencies. ]]> https://biospectrumindia.com/news/22/22795/india-and-sweden-strengthen-research-cooperation.html https://biospectrumindia.com/news/22/22795/india-and-sweden-strengthen-research-cooperation.html Mon, 13 Mar 2023 00:00:00 +0530 A Memorandum of Cooperation (MoC) has been signed between Science and Engineering Research Board (SERB), and The Swedish Foundation for International Cooperation in Research and Higher Education (STINT), Stockholm, Sweden, to strengthen cooperation and promote research networking between research institutions from both countries. The MoC was signed by Dr Akhilesh Gupta, Secretary, SERB, and Dr Andreas Göthenberg, Executive Dirctor, STINT. The MoC aims to promote mobility funding opportunities in both countries. It will facilitate academic cooperation through mobility activities as well as through seminars, workshops and conferences. Both institutions will facilitate and fund researcher mobility through their regular funding programmes. The two organisations will announce a call that will focus on funding new mobility projects that will be used to exchange several individuals, including workshops between participating research groups. Researchers and scholars at institutions of higher education in Sweden and research institutions in India are eligible to apply for funding under this call, in which applications will be jointly funded. ]]> https://biospectrumindia.com/news/22/22778/india-and-australia-join-forces-to-drive-innovation-and-create-scientific-breakthroughs.html https://biospectrumindia.com/news/22/22778/india-and-australia-join-forces-to-drive-innovation-and-create-scientific-breakthroughs.html Sat, 11 Mar 2023 00:00:00 +0530 Atal Innovation Mission (AIM), NITI Aayog and the Commonwealth Scientific and Industrial Research Organisation (CSIRO), Australia's national science agency, have joined hands by signing a Letter of Intent to encourage joint cooperation to drive innovation activities in areas of national challenges and shared priorities of both countries. The move comes during the India visit of the Australian Prime Minister Anthony Albanese as he met the Indian Prime Minister Narendra Modi on 10 March 2023 in New Delhi. The meeting between the Prime Ministers spanned across areas of mutual interest and explored avenues of strengthening bilateral engagement in a range of key areas with innovation as one key item. The Letter of Intent between AIM and CSIRO calls for a greater collaboration in areas of mutual interest and strategic priorities and serves as a general framework for cooperation intended to facilitate the development of more program specific interventions. The core of the bilateral engagement is the India Australia Innovation and Technology Challenge (IA-ITC) - a programme envisioned to bring together the innovation ecosystems of India and Australia to address shared environmental and economic challenges by supporting cohorts of startups and SMEs on their commercialisation pathways and bring to market innovative tech-based solutions spanning across circular economy, energy transition and food system resilience etc. AIM and CSIRO are currently working on the design and development of the IA-ITC programme delivery model to ensure the IA-ITC is sustainable, innovative, impactful and aligns with the strategic interests of both India and Australia. The official launch of the programme is expected to be in July 2023.   ]]> https://biospectrumindia.com/news/22/22751/government-launches-one-stop-non-stop-digital-job-portal-of-pharmacy-council-of-india-.html https://biospectrumindia.com/news/22/22751/government-launches-one-stop-non-stop-digital-job-portal-of-pharmacy-council-of-india-.html Tue, 07 Mar 2023 00:00:00 +0530 Pharmacy Council of India (PCI), the statutory body under Ministry of Health and Family Welfare, Government of India, recently organised “Pharma Anveshan 2023” to promote research & innovation, enhancing industry & academia. “It is the need of the hour to change our gears and adopt a focused approach to impart the best pharmacy education keeping our curriculum in line with the latest developments in the field and also provide extensive education of specialised drugs so as to benefit the reach of pharmacists in the country”. This was stated by Minister of State for Health and Family Welfare, Dr Bharati Pravin Pawar as she inaugurated Pharma Anveshan 2023 on the occasion of National Pharmacy Education Day on 6th March. She also launched a 'One Stop-Non Stop' digital job portal of Pharmacy Council of India, which will be useful for pharma professionals as well as recruiters from the industry. This will prove to be a game changer for the students coming from small towns and villages. At the event, PCI also signed Memorandum of Understanding (MoU) with Karnataka Drugs and Pharmaceuticals Manufacturer’s Association (KDPMA), Life Sciences Sector Skill Development Council, Ministry of Skill Development and Entrepreneurship (LSSSDC), Indian Pharma Alliance (IPA) and Federation of Pharma Entrepreneurs (FOPE) to reduce the gap of industry and academia, strengthen faculty and student training and promote entrepreneurship and infrastructure development. Dr Rajeev Singh Raghuvanshi, Drug Controller General of India elaborated on the need to promote interdisciplinary research and innovation through industry-academia strengthening. He said that the core of pharma business is quality and India has grown leaps and bounds in last 25 years in this area. He elaborated on the need to create fear free environment and risk-taking environment in order to promote innovation. ]]> https://biospectrumindia.com/news/22/22758/world-bank-signs-1-b-programme-to-support-indias-health-sector.html https://biospectrumindia.com/news/22/22758/world-bank-signs-1-b-programme-to-support-indias-health-sector.html Tue, 07 Mar 2023 00:00:00 +0530 The Government of India and the World Bank have signed two complementary loans of $500 million each to support and enhance India’s health sector development. Through this combined financing of $1 billion, the Bank will support India’s flagship Pradhan Mantri-Ayushman Bharat Health Infrastructure Mission (PM-ABHIM), launched in October 2021, to improve the public healthcare infrastructure across the country. In addition to the national level interventions, one of the loans will prioritise health service delivery in seven states including Andhra Pradesh, Kerala, Meghalaya, Odisha, Punjab, Tamil Nadu, and Uttar Pradesh. The agreement was signed by Rajat Kumar Mishra, Additional Secretary, Department of Economic Affairs, Ministry of Finance on behalf of the Government of India and Auguste Tano Kouamé, Country Director, India, World Bank. The $500 million Public Health Systems for Pandemic Preparedness Programme  (PHSPP) will support the government’s efforts to prepare India’s surveillance system to be ready to detect and report epidemics of potential international concern, ensure rapid response, and prevent emergence of pathogens; to enhance India’s capacity to detect pathogens, including zoonotic diseases, to inform India’s bio-security response and commercialisation of new technologies to prevent, detect or treat infectious diseases. The $500 million Enhanced Health Service Delivery Programme (EHSDP) will support government’s efforts to strengthen service delivery through a redesigned primary health care model, which includes improved household access to primary healthcare facilities, stronger links between each household and its primary care facility through regular household visits and risk assessment of non-communicable diseases. ]]> https://biospectrumindia.com/news/22/22744/india-and-mexico-sign-mou-on-research-technology-and-innovation-collaborations.html https://biospectrumindia.com/news/22/22744/india-and-mexico-sign-mou-on-research-technology-and-innovation-collaborations.html Sun, 05 Mar 2023 00:00:00 +0530 India and Mexico have signed a Memorandum of Understanding (MoU) on research, technology and innovation collaborations with focus on several key technology areas like Aerospace, Electronics Instrumentation & Strategic Sectors; Civil, Infrastructure & Engineering; Ecology, Environment Earth & Ocean Sciences and Water; Mining, Minerals, Metals & Materials; Chemicals (including leather) and Petrochemicals; Energy (Conventional & Non-Conventional) and Energy Devices; Agri, Nutrition & Biotech and Healthcare. The multi-sectoral agreement was signed in the presence of Union Minister for Science & Technology, Dr Jitendra Singh and Foreign Minister of Mexico Marcelo Ebrard at the India Science Centre, New Delhi in presence of high-level delegations from both the sides. Dr Jitendra Singh pointed out that Council of Scientific & Industrial Research (CSIR) and Mexican Agencies through this MoU could contribute effectively to the global society through research and innovation partnerships for technology development, upscaling of each other’s Intellectual Property for commercialisation and research infrastructure development & sharing. He said, in addition to regular research & development, capacity building & training and participation in knowledge dissemination activities, a special focus on technology and industry collaboration has been structured in the MoU. ]]> https://biospectrumindia.com/news/22/22745/big-boost-for-ayush-market-with-trade-interest-of-more-than-rs-590-cr-at-guwahati-conference.html https://biospectrumindia.com/news/22/22745/big-boost-for-ayush-market-with-trade-interest-of-more-than-rs-590-cr-at-guwahati-conference.html Sun, 05 Mar 2023 00:00:00 +0530 The first 'SCO B2B Conference and Expo on Traditional Medicine' came to a successful end on 5 March as it created a platform for buyers and sellers from different countries to explore trade potential to serve the needs of the people. An incremental trade interest of over Rs 590 crore was generated during the two days of intense meetings among the buyers and sellers at the conference. This first-of-its-kind conference & Expo under the SCO initiative was inaugurated by the Union Minister of Ayush and Ports, Shipping & Waterways Sarbananda Sonowal on 2nd March, 2023 at Guwahati, Assam. More than 150 delegates from 17 countries attended the two-day conference and four-day Expo, including high-level delegates such as Health Ministers, official delegates, and foreign buyers from SCO & partner countries. Seventy-five foreign officials and business delegates from 13 countries participated in person. Official delegates from China, Uzbekistan, Kyrgyzstan and Kazakhstan joined virtually through the internet. The B2B conference witnessed detailed presentations and deliberations from SCO and partner Countries on 'Regulatory Framework for Traditional Medicine' Products and practices, including pharmacopoeia, quality assurance and research. The Shanghai Cooperation Organisation (SCO) currently comprises eight Members- China, India, Kazakhstan, Kyrgyzstan, Russia, Pakistan, Tajikistan and Uzbekistan. ]]> https://biospectrumindia.com/news/22/22695/dbt-lays-emphasis-on-bio-based-circular-carbon-economy-through-bio-manufacturing.html https://biospectrumindia.com/news/22/22695/dbt-lays-emphasis-on-bio-based-circular-carbon-economy-through-bio-manufacturing.html Fri, 24 Feb 2023 00:00:00 +0530 India's bioeconomy is poised to touch $300 billion by 2030 and with its rising innovation and scientific temper, India is set to join the global wave of a new industrial revolution. This was stated by Union Minister of State (Independent Charge) Science & Technology Dr Jitendra Singh while speaking as the chief guest at the “National Consultation Meeting on Bio-manufacturing to build a Draft Policy Framework on Bio-manufacturing”, in New Delhi. In his address, Secretary, Department of Biotechnology (DBT), Dr Rajesh Gokhale said, "In context of Prime Minister Modi’s vision to make India a ‘Net Zero’ carbon economy’ by 2027, we expect a paradigm shift towards a bio-based circular carbon economy, by adopting an integrated and inclusive approach of Bio-manufacturing".  Dr Gokhale informed that the pilot-scale based bio-manufacturing units will employ fermentation using enhanced microbial cell factories (and sugar/biomass/waste-based raw material) to manufacture bio-based products as an alternative to chemical products across various industrial sectors. Some of these sectors include, food additives, biopharmaceuticals, biogenic dyes, bulk chemicals, animal feed products,flavours/fragrances, biomaterials, agri-bio products, etc. Dr Alka Sharma, Senior Advisor, DBT underlined that through this approach, an innovative ‘plug and play’ model of manufacturing for Industry 4.0 is being proposed. She said, the backbone of this initiative comprises advanced tools of biotechnology including synthetic biology, genome editing,metabolic engineering, etc. ]]> https://biospectrumindia.com/news/22/22671/govt-releases-rs-166-cr-incentives-under-pli-scheme-for-pharmaceuticals.html https://biospectrumindia.com/news/22/22671/govt-releases-rs-166-cr-incentives-under-pli-scheme-for-pharmaceuticals.html Tue, 21 Feb 2023 00:00:00 +0530 The Department of Pharmaceuticals (DoP) has released the first tranche of incentives under the Product Linked Incentive (PLI) scheme of pharmaceuticals amounting to Rs 166 crore to four selected applicants- Dr. Reddy's Laboratories Limited, Biocon Limited, Strides Pharma Science Limited, Premier Medical Corporation Private Limited. The Department has received an incentive claim of about Rs 544 crore from 15 applicants. Based on the evaluation, Rs 221 crore of claims of incentives from the selected four applicants were found to be eligible and 75% of this amount i.e., Rs 165.74 crore have been released. DoP launched the PLI scheme for pharmaceuticals in 2021. The financial outlay under this PLI scheme is Rs 15,000 crore over a period of six years. So far, 55 applicants have been selected under the scheme, including 20 Micro, Small & Medium Enterprises (MSMEs).  The financial year of 2022-2023 being the first year of production for the PLI Scheme, DoP has ear-marked Rs 690 crore as the budget outlay. As of January 31 2023, sales of about Rs. 36,000 cr have been reported by the select 55 applicants. 3 different categories of products are being supported under the scheme- Category 1: Biopharmaceuticals; Complex generic drugs; Patented drugs or drugs nearing patent expiry; Cell based or gene therapy drugs; Orphan drugs; Special empty capsules, Complex excipients Category 2: Bulk drugs (except those 41 eligible products notified under PLI Scheme for Bulk drugs) and Category 3: Drugs not covered under Category 1 and Category 2 such as Repurposed drugs; Auto immune drugs, anti-cancer drugs, anti-diabetic drugs, anti-infective drugs, cardiovascular drugs, psychotropic drugs and anti-retroviral drugs, including In vitro diagnostic devices (applicable to 5 applicants out of 55 applicants) ]]> https://biospectrumindia.com/news/22/22650/cdsco-gives-nod-to-astrazenecas-durvalumab-for-metastatic-biliary-tract-cancer-treatment.html https://biospectrumindia.com/news/22/22650/cdsco-gives-nod-to-astrazenecas-durvalumab-for-metastatic-biliary-tract-cancer-treatment.html Fri, 17 Feb 2023 00:00:00 +0530 AstraZeneca India has announced additional indication approval from Central Drugs Standard Control Organisation (CDSCO) for Durvalumab to treat biliary tract cancer (BTC) in India. BTC is a group of rare and aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts (cholangiocarcinoma), gallbladder or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine). Apart from ampullary cancer, early-stage BTC often presents without clear symptoms and most new cases of BTC are therefore diagnosed at an advanced stage, when treatment options are limited, and the prognosis is poor. More than 30,000 new cases of BTCs are seen in India every year with 90% of them diagnosed in the advanced stage. In fact, statistics show a high incidence of gall bladder cancer in the northern part of India. The approval for AstraZeneca molecule is based on the findings of TOPAZ-1, a Phase-3 Global clinical trial with patients recruited from India as well, that evaluated Immunotherapy plus Chemotherapy as first line treatment for advanced BTCs.  Durvalumab is already approved for use in Stage-III locally advanced, unresectable Non-Small Cell Lung Cancer (NSCLC) post chemoradiotherapy as maintenance treatment and as first line treatment in combination with chemotherapy in Extensive-Stage Small Cell Lung Cancer (ES-SCLC). In July 2022, Durvalumab plus chemotherapy was added to the National Comprehensive Cancer Network‘s (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a Category 1 preferred regimen as 1st-line therapy for locally advanced or metastatic BTC based on the data from TOPAZ-1.   ]]> https://biospectrumindia.com/news/22/22645/cabinet-approves-mou-between-india-and-south-africa-for-cooperation-in-assistive-devices.html https://biospectrumindia.com/news/22/22645/cabinet-approves-mou-between-india-and-south-africa-for-cooperation-in-assistive-devices.html Wed, 15 Feb 2023 00:00:00 +0530 The Union Cabinet, chaired by Prime Minister Narendra Modi, has approved signing of the Memorandum of Understanding (MoU) between the Government of India and the Government of South Africa for cooperation in disability sector. The bilateral MoU will encourage cooperation between the Department of Empowerment of Persons with Disabilities, Government of India and Government of South Africa through joint initiatives in the disability sector. It will strengthen bilateral ties between India and South Africa. Specific proposals for cooperation between the two countries, as mutually agreed upon, will be taken up for implementation during the period of validity of the MoU. It envisages that Persons with Disabilities (PwDs) at large and ageing population in both countries who especially require modern, scientific, durable, cost effective aids and assistive devices will be benefitted from this MoU. A number of bilateral agreements have been concluded between the two countries in diverse areas ranging from economic and commercial cooperation, defense, culture, heath, human settlements, public administration and science and technology. India’s Technical and Economic Cooperation Programme (ITEC) has been a useful medium of promoting cooperation in development of human resources. Bilateral cooperation between India and South Africa in combating COVID-19 pandemic and addressing other global challenges have been notable. Various other Ministries/ Departments have also signed MoUs / Agreement for cooperation in their relevant sectors, which further illustrate deeper relationships with Government of South Africa. ]]> https://biospectrumindia.com/news/22/22624/india-strengthens-efforts-to-eliminate-lymphatic-filariasis-by-2027.html https://biospectrumindia.com/news/22/22624/india-strengthens-efforts-to-eliminate-lymphatic-filariasis-by-2027.html Fri, 10 Feb 2023 00:00:00 +0530 Union Secretary for Health & Family Welfare, Rajesh Bhushan has launched a nationwide Mass Drug Administration (MDA) campaign aimed at ending disease transmission through the door-to-door administration of anti-filarial drugs, especially in 10 filaria affected states. This launch comes a month after the programme received resounding support from the Health Minister Dr Mansukh Mandaviya to eliminate Filariasis by 2027, three years ahead of the global target. High-burden districts in Bihar, Chhattisgarh, Jharkhand, Maharashtra, Uttar Pradesh, West Bengal, Karnataka, Odisha, Madhya Pradesh, and Andhra Pradesh have jointly launched the campaign. India has ramped up efforts in eliminating Lymphatic Filariasis, a Vector Borne Disease caused by Culex mosquitoes which causes disability well ahead of global targets to safeguard communities from disability, social and economic insecurity. Roli Singh, Additional Secretary and Mission Director (NHM), Ministry of Health and Family Welfare said that “We have adopted a multi-pronged approach with MDA round in two phases, where 1113 blocks in 90 districts across ten states will be launching a campaign against Filariasis. It was informed that in spite of 10-15 MDA rounds in the past, the LF elimination could not be achieved due to sub optimal coverage." She highlighted that over the last month, states have adopted some innovative mechanisms to reach out to communities such as Bihar has roped in 120 colleges for MDA, the Panchayati Raj Institutions (PRI), Self-Help Groups (SHGs) and other allied departments have collaborated in the MDA states to sensitise communities on MDA. ]]> https://biospectrumindia.com/news/22/22606/gavi-and-government-of-india-establish-new-partnership-to-protect-children-with-life-saving-vaccines.html https://biospectrumindia.com/news/22/22606/gavi-and-government-of-india-establish-new-partnership-to-protect-children-with-life-saving-vaccines.html Wed, 08 Feb 2023 00:00:00 +0530 Gavi, the Vaccine Alliance, and the Government of India have established a new three-year partnership that aims to reach millions of children in the country with life-saving vaccines. Through the strategic partnership, Gavi will provide $250 million in funding to identify and vaccinate children who have not received a single routine vaccine, strengthen existing health systems and help the country introduce the human papillomavirus (HPV) vaccine and typhoid conjugate vaccine (TCV) into the national routine immunisation schedule. To effectively reach the goal of reducing the number of “zero-dose” children in the country by 30%, 143 priority districts have been identified across 11 states: Uttar Pradesh, Rajasthan, Madhya Pradesh, Bihar, Haryana, Maharashtra, Jharkhand, Meghalaya, Mizoram, Arunachal Pradesh and Nagaland. In the districts where immunisation coverage is low, targeted interventions and strategies will be used to ensure children receive the full course of childhood vaccines. Civil society organisations (CSOs) and nongovernmental organisations (NGOs) will also be engaged to help build stronger demand for vaccines and generate better understanding of the importance of vaccination amongst target communities. Lessons learnt from these engagements will be replicated and expanded to other areas in the country and leveraged to strengthen routine immunisation across the nation. ]]> https://biospectrumindia.com/news/22/22572/national-ayush-mission-gets-50-increase-in-budget-allocation.html https://biospectrumindia.com/news/22/22572/national-ayush-mission-gets-50-increase-in-budget-allocation.html Thu, 02 Feb 2023 00:00:00 +0530 The government's focus on integrating Ayush system in National Health ecosystem has got a boost in the Union Budget 2023-24 presented by Finance Minister Nirmala Sitharaman on 1st Feb. The total allocation of budget to Ayush Ministry has increased by 20 percent to Rs 3647 crore. The budget has also emphasised on promoting evidence-based research in Ayush systems through Ayush research councils.   Budget allocation to centrally sponsored National Ayush Mission (NAM) has got 50 percent increase in allocation from Rs 800 core to Rs 1200 crore. NAM is majorly focused on providing cost effective Ayush Services with the universal access through up-gradation of Ayush Hospitals and Dispensaries, comprehensive primary health care through upgrading health care facilities as Health & Wellness Centers (HWC), and co-location of Ayush facilities.   NAM also supports cultivation of medical plants, production of quality and standardised ingredient for supply of Ayush, integration of medicinal plants in farming systems and increasing export of value added items of medicinal plants. All the states (Rs 920 crore), union territories (Rs 96 crore) and North eastern areas (Rs 231 crore) have also witnessed an increase in grants-in-aids i.e from Rs 861.97 crore to Rs 1246.73 crore.     ]]> https://biospectrumindia.com/news/22/22559/new-pharma-research-programme-to-be-taken-up-union-budget-2023-24.html https://biospectrumindia.com/news/22/22559/new-pharma-research-programme-to-be-taken-up-union-budget-2023-24.html Wed, 01 Feb 2023 11:00:00 +0530 As per the Union Budget for 2023-24 presented by the Finance Minister Nirmala Sitharaman on 1st February 2023, a new programme for research in pharmaceuticals will be formulated and the industry will be encouraged to invest in research. For the medical devices sector, dedicated multidisciplinary courses for medical devices will be supported in existing institutions to ensure availability of skilled manpower for futuristic medical technologies, high end manufacturing and research. In case of healthcare, a mission has been announced to eliminate sickle cell anaemia by 2047 by screening around 700 crore people. Nirmala also said that 157 new nursing colleges will be established in core locations, in sync with the existing 157 medical colleges that have been established since 2014. The Indian Council For Medical Research (ICMR) Labs will be made available for research by the public and private medical college faculty and private sector R&D teams for encouraging collaborative research and innovation. Further, the government will be creating three Centres of Excellence (CoEs) to boost Artificial Intelligence (AI) in India. These centres will be established in top Indian institutions to ensure that ‘we make AI in India’ and ‘make AI work for India’. The FM said, “Leading industry players will partner in conducting inter-disciplinary research in the areas of agriculture, health and sustainable cities.” Additionally, 100 labs will be set up for developing 5G driven applications in healthcare and other sectors, to realise new range of opportunities, business models, and employment potential. Also, Pradhan Mantri Kaushal Vikas Yojana 4.0 is to be launched to skill lakhs of youth within the next three years covering new age courses for Industry 4.0 like coding, AI, robotics, mechatronics, IOT, 3D printing, drones, and soft skills.   Click here for industry reactions on the budget ]]> https://biospectrumindia.com/news/22/22497/india-makes-efforts-to-identify-gaps-in-life-sciences-industry.html https://biospectrumindia.com/news/22/22497/india-makes-efforts-to-identify-gaps-in-life-sciences-industry.html Wed, 18 Jan 2023 00:00:00 +0530 Dr Mansukh Mandaviya, Union Minister for Health and Family Welfare, Government of India, recently addressed the roundtable discussion on “Opportunities in R&D and Innovation in Life Sciences" at the World Economic Forum, in Davos, Switzerland. The purpose of the meeting was to establish an affordable and accessible life sciences ecosystem, identify the gaps in the life sciences industry, extend opportunities for knowledge exchange and encouragement of innovation in R&D and identify investment opportunities to create a robust R&D and innovation ecosystem to increase the competitiveness of life sciences industry. Dr Mandaviya said that a large share of global value capture (nearly 40% of a market of $6.65 trillion) in the life sciences sector lies in innovation-based products. Promoting drug discovery and innovation will unlock this value and will also enhance the industry’s contribution to Indian economy (additional $10-12 billion in exports every year) and create a large pool of jobs to enhance India’s differentiation vis-a-vis other developing economy. He also spoke about the govt’s support to the medical devices sector by a production-linked incentive scheme and underlined that the bio-pharmaceuticals sector has delivered a 5-year Compound Annual Growth Rate (CAGR) of 50%. He stated that the Union Govt is focusing on strengthening the regulatory framework to facilitate innovation and research in product development; incentivising investments in innovation through a mix of fiscal and non-fiscal measures; and creating a facilitatory ecosystem to support innovation and cross-sectoral research as a strong institutional mechanism for sustainable growth in the research and development and innovation sector. ]]> https://biospectrumindia.com/news/22/22481/government-emphasises-on-lymphatic-filariasis-as-priority-disease-not-neglected.html https://biospectrumindia.com/news/22/22481/government-emphasises-on-lymphatic-filariasis-as-priority-disease-not-neglected.html Fri, 13 Jan 2023 00:00:00 +0530 “For India, Lymphatic Filariasis (LF) is not a neglected disease as may be the case in some other countries, but a priority disease for elimination in a time bound manner. India is committed to eliminating Lymphatic Filariasis by 2027, three years ahead of the global target through mission mode, multi partner, multi sector, targeted drive for which we have drawn up the roadmap”, stated Union Minister for Health & Family Welfare Dr Mansukh Mandaviya as he chaired the National Symposium on India’s Roadmap to Eliminate Lymphatic Filariasis (LF) at Vigyan Bhawan, New Delhi on 13th January 2023. The renewed five-pronged strategy for elimination of LF includes: Multi-drug administration (MDA) campaign twice a year synchronised with National Deworming Day (10th Feb and 10th August) Early diagnosis and treatment; engagement of medical colleges for strengthening morbidity management and disability (MMDP) services Integrated Vector Control with multi sectoral coordinated efforts Inter sectoral convergence with allied departments and ministries Leveraging existing digital platforms for LF and exploring alternate diagnostics Dr VK Paul, Member (Health) NITI Aayog said that LF affects specific geographies and mostly poor and downtrodden section of our society. He said that morbidity backlog needs to be cleared as soon as possible and urged for innovative practices to reach remotest parts of the country through special camps, private sector and development partners involvement for effective mitigation.  He also pushed for concurrent research through which local evidence-based decision making can take place and mass visibility campaigns at the national, state, district, sub-district and block levels. ]]> https://biospectrumindia.com/news/22/22457/nha-introduces-system-to-incentivise-and-encourage-healthcare-providers.html https://biospectrumindia.com/news/22/22457/nha-introduces-system-to-incentivise-and-encourage-healthcare-providers.html Mon, 09 Jan 2023 14:40:00 +0530 National Health Authority (NHA) is introducing a new system to measure and grade hospital performance under the flagship scheme Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY).    The new initiative will introduce the concept of ‘value-based care’, where payment will be outcome-based and providers will be rewarded according to the quality of the treatment delivered. Under the new model, the providers will be rewarded for helping the patients improve their health, which consequently will reduce the effects of the disease in the population in the long term.    The step promises a significant increase in overall health gains and is expected to be a win-win for all concerned stakeholders from patients to healthcare providers, payers and suppliers. While the patients will get better health outcomes and higher satisfaction out of the services they receive, providers stand to get better care efficiencies. Similarly, payers will be able to maximise the health benefits generated out of the spending incurred.    Under value-based care, the performance of AB PM-JAY empanelled hospitals will be measured based on five performance indicators such as: Beneficiary Satisfaction; Hospital Readmission Rate; The extent of Out-of-Pocket Expenditure; Confirmed Grievances and Improvement in patient’s Health-Related Quality of Life.   ]]> https://biospectrumindia.com/news/22/22451/all-37-csir-labs-in-india-to-turn-into-global-centres-of-research-and-innovation.html https://biospectrumindia.com/news/22/22451/all-37-csir-labs-in-india-to-turn-into-global-centres-of-research-and-innovation.html Sat, 07 Jan 2023 00:00:00 +0530 Union Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr Jitendra Singh has launched “One Week One Lab" campaign highlighting India's global excellence in technology, innovation and startups. Each of the 37 CSIR (Council of Scientific & Industrial Research)lLabs spread across the country is dedicated to a different exclusive area of work and the "on week, one lab" campaign will offer an opportunity to each one of them to showcase the work being done by it so that others can avail of it and stakeholders learn about it.  "Each of the 37 CSIR laboratories is unique and specialises in as diverse areas as Genome to Geology, Food to Fuel, Minerals to Materials, and so on", said the Minister. Director General, CSIR, Dr N Kalaiselvi said, "All the 37 labs have to come out with lots of success stories in the next 7 years for a mid term appraisal in 2030, to fulfill the vision of Prime Minister to make India innovation hub of the world in 2047." The campaign will also focus on academia and skill development, where interested students from varying domain get to know about the research activities and facilities of the CSIR laboratories and get a connect for future prospects. Another focus of the campaign is to support more and more startups and entrepreneurship in the nation with dissemination of science and wide spread of the technologies. ]]> https://biospectrumindia.com/news/22/22428/indian-oil-corporation-signs-mou-with-central-tb-division.html https://biospectrumindia.com/news/22/22428/indian-oil-corporation-signs-mou-with-central-tb-division.html Wed, 28 Dec 2022 00:00:00 +0530 Indian Oil Corporation has signed a Memorandum of Understanding (MoU), as part of its Corporate Social Responsibility (CSR) with the Central TB Division (CTD) under the Ministry of Health and Family Welfare, Government of India and the states of Uttar Pradesh and Chhattisgarh to undertake intensified tuberculosis (TB) elimination project. The MoU was signed in presence of Union Minister of Health and Family Welfare Dr Mansukh Mandaviya and Union Minister of Petroleum & Natural Gas and Housing & Urban Affairs, Hardeep Singh Puri. Uttar Pradesh and Chhatisgarh share the highest burden of TB cases among large states in India. With a multi-pronged approach that addresses all aspects of TB at its different stages, this ambitious anti-TB campaign aims to ensure early identification of presumptive TB and prompt diagnosis using high-sensitivity diagnostic tests at the doorstep. The drive also aims to offer sustainable and equitable access to free high-quality TB treatment, care, and support services to the people of Uttar Pradesh and Chhatisgarh. With this pathbreaking foray, IndianOil has emerged as the first corporate to supplement state efforts in Active Case Finding campaign (ACF) by investing close to Rs 64 crore in all 75 districts of UP, covering approximately 10% of its population once a year for three years. IndianOil will also introduce 18 Mobile Medical Vans equipped with cutting-edge diagnostic technology in Uttar Pradesh. This would aid diagnosis of TB in rural areas and hard-to-reach communities leading to improved early case detection and thereby ensuring early treatment. IndianOil will provide a cost-effective, novel molecular diagnostic machine, which will improve access, availability, and utilization of TB diagnostic services in aspirational districts of UP and remote tribal areas of Chhattisgarh. ]]> https://biospectrumindia.com/news/22/22415/madhya-pradesh-launches-science-technology-and-innovation-policy-2022-.html https://biospectrumindia.com/news/22/22415/madhya-pradesh-launches-science-technology-and-innovation-policy-2022-.html Tue, 27 Dec 2022 00:00:00 +0530 Chief Minister Shivraj Singh Chouhan unveiled the Madhya Pradesh Science, Technology and Innovation Policy 2022 on 26th December 2022. The main objective of this policy is to rank Madhya Pradesh as the top science, technology and innovation (STI) destination in the country, and to strengthen factors such as human resources, investment and knowledge-based labour force to position Madhya Pradesh in the top 5 states in the 'India Innovation Index' (from its current 13th rank) by the year 2030. The policy will also focus on developing an effective STI ecosystem and help Madhya Pradesh to increase knowledge-based production in the state by strengthening indicators such as research publications, innovations, startups, industrial design innovations and patents. There are plans to increase the enrollment ratio in STEM (science, technology, engineering and mathematics) courses at undergraduate, masters and PhD levels by promoting STEM education right from the elementary level, especially among girl students, by enriching the curriculum with STEM experiments and competitions. Further, in order to promote contextual innovation and science education, top institutions such as IITs, IIMs, will be encouraged to adopt a district in Madhya Pradesh and promote science and innovation locally in that district. Innovation clusters, incubators and accelerators will be set up in leading institutions to help startups take advantage of early funding mentorship, training and best practices through coordination with the private sector. ]]> https://biospectrumindia.com/news/22/22402/cdsco-opens-new-facility-of-south-zone-in-chennai.html https://biospectrumindia.com/news/22/22402/cdsco-opens-new-facility-of-south-zone-in-chennai.html Fri, 23 Dec 2022 00:00:00 +0530 Union Minister of Health & Family Welfare Dr Mansukh Mandaviya virtually inaugurated the new building of the Central Drugs Standard Control Organisation (CDSCO) Bhawan, South Zone at Chennai. It will facilitate drug, cosmetics safety and regulatory activities of southern States/UTs including Tamil Nadu, Puducherry, Kerala and Lakshadweep. As part of strengthening the drug regulatory system in the country, Government of India has approved various projects, construction of new CDSCO offices, new drug testing labs and upgrading of existing labs, mini labs at ports etc., under the 12th Five Year Plan”, said the Minister. With 578 blood centres, 700 drug manufacturing units, 251 cosmetics manufacturing units, 9 vaccine manufacturing units, 85 medical devices manufacturing units, 40 analytical labs and 12 BA/BE centres, CDSCO Bhawan South Zone will help in monitoring the quality of drugs through joint inspections and other licenses like blood bank license, vaccines and sera, large volume parenterals, r-DNA products, medical devices etc. They will also assist in inspection of clinical trial facilities, and public drug testing laboratory along with drawing of regular drugs samples and carrying out surprise checks/raid jointly/independently.  ]]> https://biospectrumindia.com/news/22/22396/states-uts-to-send-samples-of-covid-19-positive-cases-to-insacog-labs-to-track-new-variants.html https://biospectrumindia.com/news/22/22396/states-uts-to-send-samples-of-covid-19-positive-cases-to-insacog-labs-to-track-new-variants.html Thu, 22 Dec 2022 00:00:00 +0530 Dr Mansukh Mandaviya, Union Minister of Health and Family Welfare chaired a high-level meeting to review the COVID-19 situation in India and preparedness of public health system for surveillance, containment and management of COVID-19 in view of the recent spike in cases of COVID-19 in some countries along with Dr Bharati Pravin Pawar, Union Minister of State for Health and Family Welfare. Dr Mansukh Mandaviya directed for strengthening the surveillance system for whole genome sequencing of positive case samples to track the variants through Indian SARS-CoV-2 Genomics Consortium (INSACOG) network to ensure timely detection of newer variants, if any, circulating in the country. This would facilitate undertaking of appropriate public health measures. States/UTs have been requested to send samples of all COVID-19 positive cases to INSACOG Genome Sequencing Laboratories (IGSLs) on a daily basis, for sequencing, to track new variants, if any. A new and highly transmissible BF.7 strain of the Omicron variant has been found to be behind a wider surge of COVID-19 infections in China. Union Health Ministry has already issued “Operational Guidelines for Revised Surveillance Strategy in context of COVID-19” in June 2022 which calls for early detection, isolation, testing and timely management of suspected and confirmed cases to detect and contain outbreaks of new SARS-CoV-2 variants. Union Health Minister directed officials for ensuring effective implementation of the same.   ]]> https://biospectrumindia.com/news/22/22377/national-animal-resource-facility-for-biomedical-research-opens-at-genome-valley-hyderabad.html https://biospectrumindia.com/news/22/22377/national-animal-resource-facility-for-biomedical-research-opens-at-genome-valley-hyderabad.html Sat, 17 Dec 2022 00:00:00 +0530 Union Health Minister, Dr Mansukh Mandaviya recently inaugurated ICMR-NARFBR (Indian Council of Medical Research- National Animal Resource Facility for Biomedical Research)  at Genome Valley, Hyderabad in presence of C. Malla Reddy, Minister of Labour and Employment, Telangana. The significance of NARFBR can be adjudged from the fact that study of animals in biomedical research becomes crucial in discovering causes, diagnosis and treatment of zoonotic agents and diseases. NARFBR is an apex facility which will provide ethical care and use and welfare of laboratory animals during research. The newly build centre will work as the state-of-the-art facility for not just ethical animal studies but spans from basic, applied to regulatory animal research. It will help in capacity building of new researchers and will create processes for pre-clinical testing of new drugs, vaccines and diagnostics within the country along with quality assurance checks. Dr Rajiv Bahl, Director General of ICMR and Secretary of the Department of Health Research, termed the facility to be not just best in the country but biggest in the world. “From availability of various animals for ethical research to strengthening various processes under one umbrella, NARFBR would be an asset for the country to deal with zoonotic diseases” he added.     ]]> https://biospectrumindia.com/news/22/22337/india-to-make-significant-investment-in-rd-to-develop-roadmap-of-vaccine-development-.html https://biospectrumindia.com/news/22/22337/india-to-make-significant-investment-in-rd-to-develop-roadmap-of-vaccine-development-.html Thu, 08 Dec 2022 00:00:00 +0530 Union Minister of State (Independent Charge) Science & Technology, Dr Jitendra Singh said that India will make significant investment in R&D to develop a roadmap for design and delivery of vaccine development for future pandemic. In his message to the two-day International meet on “Preparedness for Future Epidemics: Is India ready to meet the CEPI 100 days vaccine challenge?”, Dr Jitendra Singh said, while efforts are still on to uncover findings about the COVID-19 and the epidemiological models, India is ready to invest in future challenges. The Conference on 5th and 6th December, 2022 was organized by Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology (DBT), Ministry of Science and Technology, Faridabad in its campus at NCR Biotech Science Cluster. This meeting brought together leaders and experts from academia, industry and regulators to discuss important aspects of vaccine development for emerging infectious diseases. India as a country will take lead in providing a policy framework for pandemic preparedness especially for global south, aligning respective national regulatory processes with international processes, and enhancing and pooling manufacturing capacity for large scale production quickly. This will also help the country to garner the strength of our biotech industry to improve human health and also contribute to our economy beyond its current share of $80 billion. The keynote address was delivered by Prof. K. Vijay Raghavan, former Principal Scientific Advisor to the Government of India. He cautioned that while we were lucky to have a strong immunogenic spike protein antigen for the coronavirus, this may not be the case with other infections. Therefore, developing a sustainable and economically viable system flow for achieving 100 day challenge was critical. Dr Soumya Swaminathan, Chief Scientist, WHO emphasised the need for India to develop road maps and target product profile for diseases important for India. She mentioned that WHO had set up a committee to prioritize viral families and pick prototypes from these families for vaccine development. . ]]> https://biospectrumindia.com/news/22/22334/india-strengthens-research-in-traditional-medicine-for-affordable-healthcare.html https://biospectrumindia.com/news/22/22334/india-strengthens-research-in-traditional-medicine-for-affordable-healthcare.html Tue, 06 Dec 2022 00:00:00 +0530 Union Minister of Ayush Sarbananda Sonowal has announced that three National Ayush Institutes - All India Institute of Ayurveda (AIIA), Goa, National Institute of Unani Medicine (NIUM), Ghaziabad and National Institute of Homoeopathy (NIH), Delhi will be dedicated to the nation by Prime Minister (PM) Narendra Modi on 11th December 2022. These satellite institutes will further strengthen the research, international collaborations and facilitate affordable Ayush services for larger community. Establishment of these three National Ayush institutes in Ayurveda, Homeopathy and Unani will create 400 additional seats for students, who want to pursue UG, PG and Doctoral courses and also add 550 additional beds in these three streams. All India Institute of Ayurveda (AIIA), Goa will work to provide the highest quality facilities for UG, PG and post-doctoral streams in the aspects of education, research and patient care services through Ayurveda system of medicine. It will be developed into a wellness hub of Ayurveda promoting Medical Value Travel (MVT) and will function as a model centre for international and national collaboration for academic & research purposes. The National Institute of Homoeopathy (NIH), Delhi is first of its kind to be established in Northern India for developing the Homoeopathic system of medicine and to provide healthcare facilities; while National institute of Unani Medicine (NIUM), Ghaziabad, Uttar Pradesh will be a satellite centre of the existing National Institute of Unani Medicine, Bengaluru.  ]]> https://biospectrumindia.com/news/22/22315/cdsco-approves-astrazenecas-anti-diabetic-drug-dapagliflozin-with-additional-indications.html https://biospectrumindia.com/news/22/22315/cdsco-approves-astrazenecas-anti-diabetic-drug-dapagliflozin-with-additional-indications.html Tue, 29 Nov 2022 00:00:00 +0530 AstraZeneca India has received the Central Drugs Standard Control Organisation’s (CDSCO) approval for their anti-diabetic drug Dapagliflozin in the treatment of adults with chronic kidney disease (CKD). Dapagliflozin is the first and only anti-diabetic drug approved to significantly reduce the risk of sustained eGFR (estimated Glomerular Filtration Rate), cardiovascular deaths and hospitalisations due to heart failure in adults with progressive chronic kidney disease. This approval is applicable for both diabetic and non-diabetic CKD patients. The approval is based on the consistent results from the DAPA-CKD study, where the indication has now been recommended in adults with Chronic Kidney Disease, up to an eGFR greater than or equal to 25 ml per min per 1.73 m2. Below this, the initiation is currently not recommended, however patients may continue with their daily dose of 10mg orally to reduce the risk of eGFR decline, End Stage Kidney Disease (ESKD), cardiovascular deaths and heart failures. Earlier only up to CKD stage 3 patients could be initiated Dapagliflozin but with this approval physicians can initiate Dapagliflozin for a subset of CKD stage 4. AstraZeneca’s Dapagliflozin is an oral anti-diabetes drug which has shown increasing benefits in not only preventing heart failure but also in managing chronic kidney disease and heart failure with reduced ejection fraction irrespective of diabetes status.   ]]> https://biospectrumindia.com/news/22/22296/bharat-biotechs-intranasal-vaccine-incovacc-receives-heterologous-booster-approval.html https://biospectrumindia.com/news/22/22296/bharat-biotechs-intranasal-vaccine-incovacc-receives-heterologous-booster-approval.html Mon, 28 Nov 2022 00:00:00 +0530 Hyderabad-based Bharat Biotech has announced that iNCOVACC (BBV154), has received approval from the Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for ages 18 and above, in India, for heterologous booster doses.     iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilized SARS-CoV-2 spike protein. This vaccine candidate was evaluated in phases I, II and III clinical trials with successful results. The vaccine has been specifically formulated to allow intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries.     iNCOVACC was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated in preclinical studies for efficacy. Washington University licensed the vaccine technology to Bharat Biotech in 2020 for further development.   Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, and as heterologous booster dose for subjects who have previously received two doses of the two commonly administered COVID-19 vaccines in India.     Dr Rajesh S. Gokhale, Secretary, DBT, and Chairperson, BIRAC, said, “The DCGI’s approval of Bharat Biotech’s intranasal vaccine iNCOVACC (BBV154) to be used as a heterologous booster dose against currently available COVID-19 vaccines is a moment of great pride for our country. This move will further strengthen our collective fight against the pandemic and broaden vaccine coverage.”           ]]> https://biospectrumindia.com/news/22/22290/ministry-of-ayush-inks-mou-with-department-of-science-and-technology.html https://biospectrumindia.com/news/22/22290/ministry-of-ayush-inks-mou-with-department-of-science-and-technology.html Fri, 25 Nov 2022 00:00:00 +0530 A Memorandum of Understanding (MoU) has been signed between Ministry of Ayush, Government of India and Department of Science and Technology (DST), Ministry of Science and Technology & Earth Sciences. The MoU will identify the potential areas of research to explore cooperation, convergence, and synergy for evidence-based scientific intervention in the Ayush sector and further application of these into the public healthcare system. The MoU was signed by Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush and Dr Srivari Chandrasekhar, Secretary, DST in presence of senior officials from Ministry of Ayush and scientists of DST. Through the MoU, Ministry of Ayush and DST have agreed to jointly undertake R&D activities on scientific validation of Ayush concepts, procedures and products, create a platform for the exchange of information and bring about the application of modern science toward understanding the Ayush-related basic concepts and principles. The Ministry of Ayush would identify thrust areas involving Ayush-related systems that require understanding the basic concepts, procedures, development of newer tools, and so on in modern sciences. Meanwhile, DST, through the Science and Engineering Research Board (SERB), would coordinate the implementation of thrust areas through well-chartered plans and mutual concerted actions.   ]]> https://biospectrumindia.com/news/22/22267/principal-scientific-adviser-prof-ajay-sood-launches-bengaluru-science-technology-cluster.html https://biospectrumindia.com/news/22/22267/principal-scientific-adviser-prof-ajay-sood-launches-bengaluru-science-technology-cluster.html Fri, 18 Nov 2022 00:00:00 +0530 At the Bengaluru Tech Summit, held from 16th to 18th November, Principal Scientific Adviser Prof. Ajay Sood launched Bengaluru Science & Technology Cluster (BeST). This effort was coordinated by the Indian Institute of Science (IISc) in partnership with Centre for Cellular and Molecular Platforms (C-CAMP). A proposal for funding for BeST was submitted with Principal Investigator (PI) Prof. Govindan Rangarajan (Director, IISc) and co-PIs Prof. Ambarish Ghosh (Professor IISc) and Dr Taslimarif Saiyed (CEO, CCAMP). The funding was recently sanctioned by the Office of the Principal Scientific Adviser to the Government of India. During the launch, Prof. Sood emphasised that Bengaluru has enormous technological potential and that Karnataka State is among the leaders in science and technology advancements. He anticipates that the cluster will succeed and pave the path for future success. A science and technology cluster is a collaborative ecosystem in a city or a region, in which scientists, engineers, social scientists, and entrepreneurs working in academia, government labs, and industry identify and collaborate to solve some socially relevant problems. Science & Technology (S&T) Clusters are being established as formal umbrella structures for S&T organisations in various cities to work together more effectively while retaining their autonomy. On the recommendation of the Prime Minister's Science, Technology, and Innovation Advisory Council (PM-STIAC) to build an Atmanirbhar Bharat through S&T, the O/o PSA supports these initiatives.  The Bengaluru Science and Technology Cluster (BeST), the latest in this set of O/o PSA supported clusters, has identified Health & Wellness, Urban Life, and Futuristic Technologies as its core sectors and has set up teams to work on areas of One Health, Digital Health, Precision Agriculture, Urban Transportation, Monsoon & Climate Change, Quantum Technologies, Active Matter & Robotics and Jet Engine. As Prof Sood explained, the BeST Cluster is envisaged as a platform of active collaboration for the entire R&D ecosystem in Bengaluru cutting across disciplines and mandates but retaining their individual autonomy. A Section 8 company is being set up to catalyse this collaboration as an independent body, provide organizational support and raise and manage resources. The earlier S&T Clusters in this programme have been set up in Pune, Jodhpur, Delhi-NCR, Bhubaneshwar and Hyderabad.   ]]> https://biospectrumindia.com/news/22/22258/karnataka-to-develop-six-new-knowledge-cities-for-science-technology-and-startup-park-.html https://biospectrumindia.com/news/22/22258/karnataka-to-develop-six-new-knowledge-cities-for-science-technology-and-startup-park-.html Thu, 17 Nov 2022 00:00:00 +0530 The 25th edition of Bengaluru Tech Summit 2022 opened on 16 November in the form of a glittering ceremony in the presence of a galaxy of leaders from the IT, biotechnology (BT) and startup sectors.  Speaking on the occasion, Basavaraj S. Bommai, Chief Minister of Karnataka announced the setting up of six new cities in Karnataka to promote the growth of the knowledge, science anf technology sectors in the state. These new cities will be developed in Kalaburagi, Hubballi-Dharwad, Mangaluru, Mysuru and Bengaluru. These cities will be well planned, high-tech and help promote IT, BT and startups. A dedicated Startup Park will be developed near the Bengaluru international airport which will be multi-modal and help promote various spheres of the startup ecosystem. The Minister said that the state needs to do much more for the growth of the startup industry. He also announced that Knowledge and Technology City will be created near Bengaluru International Airport. He further added that the government will begin work on developing these cities within the next six months. Bommai also called upon the leaders of the scientific world to innovate for the betterment of the human race and develop technologies to create a new healthy human being and better future for all. Dr C.N. Ashwath Narayan, Minister for Electronics, IT, Bt and S&T, Higher Education; Skill Development, Entrepreneurship & Livelihood, Government of Karnataka said the government of Karnataka has been enabling the right kind of learning and education in a big way to promote the growth of the knowledge sectors. The state government has set a target of achieving $300 billion digital economy by 2025, the share of bio technology will be $36 billion. The Minister lauded the startup industry in Karnataka for achieving distinction of the first and the 100th unicorns in the country.       ]]> https://biospectrumindia.com/news/22/22135/india-unveils-blueprint-for-national-medical-oxygen-grid.html https://biospectrumindia.com/news/22/22135/india-unveils-blueprint-for-national-medical-oxygen-grid.html Wed, 19 Oct 2022 01:05:00 +0530 To support the goals of the Oxygen-for-India campaign, and with support from USAID-RISE, the Bill & Melinda Gates Foundation, and the Swasth Alliance, the One Health Trust (OHT) embarked on an effort to develop a national oxygen grid, that can ensure timely availability of medical oxygen which can save lives, including those of children suffering from respiratory ailments, pregnant women, patients with severe malaria, cardiovascular disease, and traumatic injuries. The “Blueprint for a National Medical Oxygen Grid in India” was launched on October 19 in Bengaluru by D. Randeep IAS, Comissioner, Health and Family Welfare Services, Government of Karnataka and heralds the advent of self-reliance in the supply of medical oxygen throughout the country.    The report presents a comprehensive assessment of the current and future medical oxygen needs of India and the design and implementation of a National Medical Oxygen Grid (NMOG).   The report finds that the lack of utilization of medical oxygen, especially outside of major metros, meant that there was both a lack of supply as well as a lack of personnel trained to use medical oxygen.  It is vital to fix the problem and ensure that oxygen is widely available and used in the farthest corners of the country during normal times so that the country’s infrastructure is ready for any future crisis.   This report lays the groundwork for the design and implementation of the grid. It recommends a four-step approach for the design of the NMOG.  The first step is to model and plan exercises to forecast the demand that must be met. The second is to divide the demand into manageable distribution areas to ease distribution. The third step is to create a detailed supply-side assessment so that the demands forecasted in step 1 may be met. The final step is to design the grid network that would include detailed steady-state and exigency operational plans.  ]]> https://biospectrumindia.com/news/22/22122/new-cdsco-notice-simplifying-sale-license-requirements-disrupts-contact-lens-business-mtai.html https://biospectrumindia.com/news/22/22122/new-cdsco-notice-simplifying-sale-license-requirements-disrupts-contact-lens-business-mtai.html Fri, 14 Oct 2022 00:00:00 +0530 Medical Technology Association of India (MTaI) has welcomed the Central Drugs Standard Control Organization (CDSCO) notice GSR 754 (E) simplifying sale license requirementsfor retailers and wholesalers who are involved in stock or sale of medical devices by also allowing registration certificate in its lieu. The association which represents a significant portion of the contact lens industry, also pointed out that the simplified sale license requirements are well intended but expressed concerns regarding their on-ground implementation.   Pavan Choudary, Chairman & Director General, MTaI, said, “Contact lenses & lens care products are being sold for several decades in the country outside of a sale license requirement in optical stores and contact lens clinics. The new sales license rules though welcome , would mean that thousands of these optical shops now need to go through this mechanism for registration. Most of these units are not aware of the sales license requirement and the process to get the registration certificate. This has disrupted the contact lens business”.    “Till the mechanism is ready for implementation of GSR 754 (E), we request the CDSCO to urgently provide extension for the implementation of sale license or registration certificate requirements for Contact Lenses and Lens Care products. As most of the optical shops and contact lens clinic are included in the registration process for the first time, they need sufficient time to understand the regulations and take the necessary approvals. Therefore, a transition time of 5-6 months should be provided to ensure smooth compliance”, appealed Sanjay Bhutani, Managing Director, Bausch & Lomb India.   ]]> https://biospectrumindia.com/news/22/22106/pm-lays-foundation-stone-of-bulk-drug-park-in-una-himachal-pradesh.html https://biospectrumindia.com/news/22/22106/pm-lays-foundation-stone-of-bulk-drug-park-in-una-himachal-pradesh.html Thu, 13 Oct 2022 09:00:00 +0530 The Prime Minister (PM) Narendra Modi has laid the foundation stone of Bulk Drug Park and dedicated the Indian Institute of Information Technology (IIIT) Una to the nation. The PM pointed out that Himachal has been chosen as one of the states to get a bulk drug park. “Being chosen as one of the only three states for a bulk drug park is a momentous decision for the state and is a result of our affection and dedication for the state”, he said.  Modi also informed that Himachal Pradesh has played a crucial role in making India the number one medicine manufacturer in the world and its possibilities are only going to increase. “The entire world has witnessed the strength of the medicines manufactured in Himachal Pradesh”, Modi added. He further pointed out that now that raw materials for medicine manufacturing will be produced in Himachal Pradesh, India’s dependency on the other nations is going to decrease significantly.  The Prime Minister highlighted that the government is providing free treatment expenses up to five lakh rupees for the poor and needy through Jan Aushadhhi Kendra under the aegis of Ayushman Bharat Scheme. “Bulk Drug Park will give further strength to the government’s campaign to provide quality and affordable medical care to people”, he pointed out. The Bulk Drug Park will help reduce dependence on API imports. It is expected to attract investment of around Rs 10,000 crore and provide employment to more than 20,000 people. It will also give a fillip to economic activities in the region.    ]]> https://biospectrumindia.com/news/22/22086/national-helicopter-medical-emergency-plan-to-launch-in-india.html https://biospectrumindia.com/news/22/22086/national-helicopter-medical-emergency-plan-to-launch-in-india.html Mon, 10 Oct 2022 17:10:00 +0530 Jyotiraditya M Scindia, Minister for Civil Aviation and Steel, Govt of India has announced 3 new projects for enhancing the helicopter sector in the country which includes Project Akash, Helicopter medical emergency services (HEMS) and fractional ownership. The Minister launched new Helicopter Emergency Medical Services under project ‘Sanjeevani’ and the service will start at AIIMS, Rishikesh. “Through the learnings from project ‘Sanjeevani’, we will put in place a National Helicopter Medical Emergency plan in the days to come,” he added. Addressing the ‘4th Heli-India Summit 2022 – Helicopters for Last Mile Connectivity’, organized by FICCI, jointly with the Ministry of Civil Aviation, Govt of India and Govt of J&K, Scindia said that the government intends to expand medical outreach and access to trauma care services to a wider population across the country using helicopters. Helicopters, he said, have multifarious role by providing urban connectivity and the government has started providing helicopter connectivity between airports and cities at economical rates. Helicopters also have important role in providing medical services along with disaster management. In last one year, the government has introduced ‘Heli Sewa’ portal for providing all permissions to operators there by providing Ease of Doing Business. "We also have introduced Heli-Disha to set up more helipads, one helipad in one district. The government has also removed all landing and parking charges for helicopters to boost the sector,” he added.     ]]> https://biospectrumindia.com/news/22/22063/pm-lays-foundation-stone-of-medical-device-park-at-nalagarh-hp.html https://biospectrumindia.com/news/22/22063/pm-lays-foundation-stone-of-medical-device-park-at-nalagarh-hp.html Wed, 05 Oct 2022 09:00:00 +0530 Prime Minister (PM) Narendra Modi laid the foundation stone of the Medical Device Park at Nalagarh, Himachal Pradesh (HP) which will be built at a cost of about Rs 350 crore. The PM observed that it is a moment of pride for the people of Himachal Pradesh as it is one of the three states that have been selected for the Bulk Drugs Park. Himachal Pradesh is also one of the four states that have been selected for Medical Devices Park and the Nalagarh Medical Device Park is part of this. Memorandums of Understanding (MoUs) of more than Rs 800 crore have already been signed for setting up industries in this Medical Device Park. The project will significantly enhance employment opportunities in the region. During his visit to HP, the Prime Minister visited & inaugurated AIIMS, Bilaspur constructed at a cost of more than Rs 1470 crore. It is a state-of-the-art hospital with 18 speciality & 17 super speciality departments, 18 modular operation theatres, and 750 beds with 64 ICU beds. ]]> https://biospectrumindia.com/news/22/21995/govt-approves-establishment-of-exports-promotion-council-for-medical-devices.html https://biospectrumindia.com/news/22/21995/govt-approves-establishment-of-exports-promotion-council-for-medical-devices.html Thu, 22 Sep 2022 12:00:00 +0530 As a big boost to the Indian Medical Devices Manufacturing, the long sought and requested Medical Devices Exports Promotion Council (EPC) is finally sanctioned to be created under the aegis of Department of Pharmaceuticals (DoP), Govt. of India. This strategic step is expected to go a long way in accelerating the exports and manufacturing growth of the medical devices sector. According to the government's notification, the EPC shall be established with headquarters at Yamuna Expressway Industrial Development Authority (YEIDA), Greater Noida and regional offices in Andhra Pradesh and Telangana. For setting up the headquarters, YEIDA will provide an initial funding of Rs 3 crore. The regional office at Andhra Pradesh will be set up by 2023, while the Telangana office will be ready by 2025. "The Exports Promotion Council for Medical Devices will help bring in coordinated inter-ministerial policy measures for unleashing the huge export potential and investment potential of over Rs 80,000 crore for manufacturing medical devices for the Global market in India’s quest to be one of Top 5 preferred supplier base of medical devices worldwide and we are thankful to the Minister of Commerce and Industry in taking this initiative to help realise our Prime Minister’s vision,” said Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD).    ]]> https://biospectrumindia.com/news/22/21947/health-ministry-launches-national-lists-of-essential-medicines-nlem-2022.html https://biospectrumindia.com/news/22/21947/health-ministry-launches-national-lists-of-essential-medicines-nlem-2022.html Tue, 13 Sep 2022 06:00:00 +0530 Dr Mansukh Mandaviya, Union Minister for Health and Family Welfare launched National Lists of Essential Medicines (NLEM) 2022, in New Delhi on 13th September. 384 drugs have been included in this list with addition of 34 drugs, while 26 from the previous list have been dropped. The medicines have been categorized into 27 therapeutic categories. Speaking on the occasion, Union Health Minister stated that the “essential medicines” are those that satisfy the priority health care needs, based on efficacy, safety, quality and total cost of the treatment. The primary purpose of NLEM is to promote rational use of medicines considering the three important aspects i.e., cost, safety and efficacy.  In NLEM, the medicines are categorized based on level of healthcare system as-     P- Primary; S- Secondary and T- Tertiary. The National List of Essential Medicines was first formulated in 1996 and it was revised thrice earlier in 2003, 2011, and 2015. Dr Bharati Pravin Pawar, Union Minister of State stressed on enhancing awareness regarding Antimicrobial Resistance (AMR) which “is emerging as a big challenge for our scientists and community and we need to create awareness in the society about AMR”. Revision of NLEM 2022 has been done after constant consultation with stakeholders spanning from academia, industrialists and public policy experts etc., and crucial documents like WHO EML 2021.     ]]> https://biospectrumindia.com/news/22/21922/medtech-import-dependence-to-reduce-from-80-to-below-30-in-next-10-yrs.html https://biospectrumindia.com/news/22/21922/medtech-import-dependence-to-reduce-from-80-to-below-30-in-next-10-yrs.html Wed, 07 Sep 2022 00:00:00 +0530 Union Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr Jitendra Singh said, Healthcare sector in India is expected to grow to reach a size of $50 billion by 2025. Addressing the 14th CII Global MedTech Summit titled “Seizing the Global Opportunity” on 7th September, Dr Jitendra Singh said, under Prime Minister Modi, healthcare has become more focused on innovation and technology over the past two years and 80% of healthcare systems are aiming to increase their investment in digital healthcare tools in coming five years. Dr Jitendra Singh said, the prime objective of the government is to reduce import dependence from 80% to below 30% in next 10 years and ensure self-reliance quotient of 80% in Medtech through Make in India with SMART milestones. He said, towards this, the Indian Government has undertaken structural and sustained reforms to strengthen the healthcare sector and has also announced conducive policies for encouraging FDI. This has led to a change in trend, with the country becoming a hotbed of MedTech innovation and instead of adopting western products, Indian innovators are developing path breaking MedTech products and solutions. India has reached an inflection point, which is leading to rapid expansion of HealthTech/ MedTech ecosystem. Dwelling on the Vision @ 2047, Dr Jitendra Singh said, it is expected that India becomes one of the top markets in medical devices upwards of 14% - 15%. He said, this global position is attainable by achieving the targets set in the National Infrastructure Pipeline 2020, to build 73 new medical colleges to increase domestic consumption and improve healthcare infrastructure. ]]> https://biospectrumindia.com/news/22/21919/bharat-biotechs-covid-19-intranasal-vaccine-gets-emergency-use-approval.html https://biospectrumindia.com/news/22/21919/bharat-biotechs-covid-19-intranasal-vaccine-gets-emergency-use-approval.html Tue, 06 Sep 2022 00:00:00 +0530 Bharat Biotech has announced that iNCOVACC (BBV154) has received approval under Restricted Use in Emergency Situation for ages 18 and above.     iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results. iNCOVACC has been specifically formulated to allow intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost effective in low- and middle-income countries.      iNCOVACC was developed in partnership with Washington University St. Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy. Product development and clinical trials were funded in part by the Government of India through the Department of Biotechnology’s, COVID Suraksha programme.   Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, as heterologous booster dose for subjects who have previously received 2 doses of the two commonly administered covid vaccines in India.    Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech, said, “Despite the lack of demand for COVID-19 vaccines, we continued product development in intra nasal vaccines to ensure that we are well prepared with platform technologies for future infectious diseases."  ]]> https://biospectrumindia.com/news/22/21902/centre-approves-three-bulk-drug-parks-in-hp-gujarat-and-ap.html https://biospectrumindia.com/news/22/21902/centre-approves-three-bulk-drug-parks-in-hp-gujarat-and-ap.html Fri, 02 Sep 2022 00:00:00 +0530 The Department of Pharmaceuticals has conveyed ‘in-principle’ approval to the proposals of the three States Viz, Himachal Pradesh (HP), Gujarat and Andhra Pradesh (AP) under the Scheme for 'Promotion of Bulk Drug Parks', a key initiative to support bulk drug manufacturing in the country.   The scheme, with a financial outlay of Rs 3,000 crores notified in 2020, provides financial assistance to three states for establishing bulk drug parks and aims to bring down the cost of manufacturing bulk drugs by creation of world-class common infrastructure facilities supported by the Central Government and thereby increase the competitiveness of the domestic bulk drug industry.   Under the scheme, proposals were received from 13 States. The Department was guided by an Advisory Committee under CEO, NITI Aayog in the appraisal of the proposals, based on the quantitative as well as qualitative methodology.   The financial assistance to the proposed Bulk Drug Park in Gujarat and Andhra Pradesh would be 70 per cent of the project cost of common infrastructure facilities. In the case of Himachal Pradesh, being a hilly state, financial assistance would be 90 per cent of the project cost. Maximum assistance under the scheme for one Bulk Drug Park would be limited to Rs 1000 crores.   As per the proposals submitted by these States, the Bulk Drugs will be established in 1402.44 acres of land at Tehsil Haroli, District Una, Himachal Pradesh, 2015.02 acres of land at Tehsil Jambusar, District Bharuch, Gujarat and 2000.45 acres of land at KP Puram & Kodhada of Thondagi Mandal of East Godavari District, Andhra Pradesh. These three states were instructed to submit their detailed project reports in the next 90 days, to appraise the same and to process for issuance of final approval under the scheme. ]]> https://biospectrumindia.com/news/22/21889/ayush-ministry-takes-significant-step-for-standardisation-of-traditional-medicine-.html https://biospectrumindia.com/news/22/21889/ayush-ministry-takes-significant-step-for-standardisation-of-traditional-medicine-.html Tue, 30 Aug 2022 17:30:00 +0530 A Memorandum of Understanding (MoU) has been signed between Pharmacopoeia Commission for Indian Medicine and Homoeopathy pr PCIM&H (Ministry of Ayush) and the Indian Pharmacopoeia Commission or IPC (Ministry of Health & Family Welfare) in New Delhi for Inter-Ministerial cooperation for the promotion and facilitation of 'One Herb, One Standard.'    Prof (Vaidya) PK Prajapati, Director (In-Charge), PCIM&H and Rajeev Singh Raghuvanshi, Secretary-cum-Scientific Director signed the MoU in the presence of Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush.   The MoU will further facilitate collaboration for promoting the exchange of information in the area of standardisation of Traditional medicine by sharing scientific information and drug raw materials/extracts, seminars, workshops, training and brainstorming programmes.   The sole authority of publication of monographs categorised under the 'one herb one standard' will lie with PCIM&H only. The monograph(s), as per the MoU, developed by PCIM&H and IPC will be identified accordingly; IPC’s contribution in the respective monographs shall be recognised in an appropriate place. The technical content of the monographs will be jointly developed by PCIM&H and IPC. Hence, these monographs will have the same legal sanctity as published in ASU&H pharmacopoeia and IP.      ]]> https://biospectrumindia.com/news/22/21873/government-launches-digital-tools-developed-by-national-pharmaceutical-pricing-authority-.html https://biospectrumindia.com/news/22/21873/government-launches-digital-tools-developed-by-national-pharmaceutical-pricing-authority-.html Mon, 29 Aug 2022 15:55:00 +0530 Union Minister of Chemical and Fertilizers, Dr Mansukh Mandaviya recently addressed the Silver Jubilee Celebrations of the National Pharmaceutical Pricing Authority (NPPA) where two digital tools were launched by the Minister- Integrated Pharmaceutical Database Management System 2.0 (IPDMS 2.0) and Pharma Sahi Daam 2.0 App.IPDMS 2.0 is an integrated responsive cloud-based application developed by NPPA with technical support from the Centre for Advance Computing (C-DAC). It is envisaged to optimise synergies in operations to promote Government’s thrust on ‘Ease of Doing Business’ as it would provide a single window for submissions of various forms as mandated under the Drug Price Control Order (DPCO), 2013. It would also enable the paperless functioning of NPPA and facilitate the stakeholders to connect with National Pharma Pricing Regulator from across the country.Pharma Sahi Daam 2.0 App will have updated features like speech recognition; availability in Hindi and English; a share button and bookmarking medicines. This version of Pharma Sahi Daam also has a facility for launching complaints by the consumer through the consumer complaint handling module. The App will be available in both iOS and Android versions.A publication titled 'An overview of Drug Pricing @ NPPA 25-year Odyssey' was also launched at the inaugural session. The publication chronicles not only the 25 year journey of NPPA but also highlights the evolution of the drug regulatory system in the country with special emphasis on pricing regulation. ]]> https://biospectrumindia.com/news/22/21839/nha-issues-hardware-guidelines-for-health-institutions-at-state-ut-level.html https://biospectrumindia.com/news/22/21839/nha-issues-hardware-guidelines-for-health-institutions-at-state-ut-level.html Tue, 23 Aug 2022 11:35:00 +0530 The National Health Authority (NHA) issued hardware guidelines across States and Union Territories for healthcare institutions like hospitals, clinics and health and wellness centres to promote digitisation in hospitals. The guidelines provide a basic framework to States/UTs for planning, assessment and procurement of the IT hardware (including IT specifications of various hardware equipment) to operate applications compliant with Ayushman Bharat Digital Mission (ABDM).   ABDM will simplify the processes and increase ease of living by connecting the digital health solutions of hospitals and other health facilities across the country with each other. The digital ecosystem will also enable a host of other facilities like teleconsultation, paper-less health records, QR code-based OPD registrations etc. The digitisation of health records will ensure that old medical records of patients cannot get lost and are accessible to them anytime anywhere. Ensuring the necessary IT infrastructure and implementation of Hospital Information Management Systems across health facilities at the State/UT level will play a pivotal role in the creation and exchange of digital health records across the ecosystem.    The guidelines on the IT hardware specifications to support this ecosystem is available at https://abdm.gov.in:8081/uploads/Hardware_Guidelines_ABDM_e162cf7a7b.pdf. The document will help the States/ UTs in assessing the hardware requirements while planning and procurement of IT assets for healthcare institutions of all scales. The guidelines published by NHA are suggestive and recommendatory. States/UTs and health facilities have the flexibility to modify these guidelines based on local requirements and circumstances.  ]]> https://biospectrumindia.com/news/22/21810/nha-to-allocate-rs-100-cr-to-states-uts-for-performance-based-health-activities.html https://biospectrumindia.com/news/22/21810/nha-to-allocate-rs-100-cr-to-states-uts-for-performance-based-health-activities.html Wed, 17 Aug 2022 12:55:00 +0530 The National Health Authority (NHA) has announced fund allocation to States and Union Territories (UTs) for the implementation of the Ayushman Bharat Digital Mission (ABDM) based on their performance in recording data in the Health Facility Registry (HFR) and Healthcare Professionals Registry (HPR).   This performance-based fund allocation shall help in the structured implementation of the ABDM at State/UT level with verified entries strengthening the key national registries being built under the scheme.    As per the earlier guidelines issued by NHA, Rs 500 crore had been demarcated for setting up of ABDM offices at State/ UT level over five years (FY 2021-22 to FY 2025-26). 20 per cent of these funds, i.e., Rs 100 crore were earmarked as incentive-based funds. Taking this thought further, NHA decided to extend the current fund allocation based on the performance of respective states and UTs in terms of the number of entities (healthcare professionals like doctors, nurses etc. and health facilities like hospitals, clinics, health and wellness centres, diagnostic labs, pharmacies etc.) that the respective States/ UTs register and verify within a stipulated period.    The population of the Health Facility Registry (HFR) and Healthcare Professionals Registry (HPR) is crucial to achieving the intended objective of ABDM. The introduction of performance-based funding to States & UTs is an initiative in this direction.            ]]> https://biospectrumindia.com/news/22/21804/principal-scientific-adviser-to-goi-unveils-manthan-platform.html https://biospectrumindia.com/news/22/21804/principal-scientific-adviser-to-goi-unveils-manthan-platform.html Tue, 16 Aug 2022 15:40:00 +0530 The Office of the Principal Scientific Adviser (PSA) to the Government of India (GoI) has launched Manthan platform, which aims to promote collaboration at scale between industry and the scientific research and development ecosystem to help meet India’s sustainability goals in alignment with the UN defined Sustainable Development Goals (SDG) charter.    Led by the Office of PSA, Manthan can potentially change the landscape of science and technology-based social impact innovation and solutions in India. The platform will facilitate knowledge transfers and interactions through information exchange sessions, exhibitions, and events to develop a framework for future science, innovation, and technology-led growth.   Powered by Knowledge driven Foundation & Technology driven Innovation (NSEIT), the platform will empower to scale up the interactions among stakeholders, facilitate research and innovation, and share challenges in various emerging technologies and scientific interventions, including those that make a social impact.  ]]> https://biospectrumindia.com/news/22/21794/ministry-of-ayush-signs-mou-with-meity.html https://biospectrumindia.com/news/22/21794/ministry-of-ayush-signs-mou-with-meity.html Sat, 13 Aug 2022 07:25:00 +0530 A Memorandum of Understanding (MoU) has been signed between the Ministry of Ayush and the Ministry of Electronics and Information Technology (MeitY) for providing technical support to the Ministry of Ayush for the digitalisation of the Ayush Sector under the Ayush Grid project for three years. This MoU is the continuation of the earlier MoU, which was signed in the year 2019.   Vaidya Rajesh Kotecha, Secretary, Ayush and Alkesh Kumar Sharma, Secretary MeitY signed the MoU on behalf of both the Ministries. It was decided that both the ministries will continue to work in collaboration and MeitY along with organisations under MeitY will extend all technical support required for the Ayush Grid project including the adoption of emerging technologies.    Ministry of Ayush has conceptualized ‘Ayush Grid’ Project, as part of the Digital India Program, which leverages ‘Information and Technology’ to transform operational efficiency, improve service delivery and enhance quality of services. The Ayush Grid platform is envisaged to be the IT backbone; allowing integration of all stakeholders and functions/ services related to Ayush systems of health care. From a user’s perspective, Ayush Grid is the proposed central IT platform offering multiple IT services for all systems of medicines under Ayush viz. Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa Rigpa and Homeopathy across functional areas, namely, healthcare delivery, education, research, capacity building, drug licensing and standardization along with media outreach. ]]> https://biospectrumindia.com/news/22/21793/union-health-secretary-inaugurates-3rd-national-conference-on-ermed.html https://biospectrumindia.com/news/22/21793/union-health-secretary-inaugurates-3rd-national-conference-on-ermed.html Sat, 13 Aug 2022 07:10:00 +0530 Rajesh Bhushan, Union Secretary for Health and Family Welfare inaugurated the 3rd National Conference “ERMED Consortium: Digital Health Resources: A reality” in the presence of Dr (Professor) Atul Goel, DGHS at National Medical Library, in New Delhi.National Medical Library’s Electronic Resources in Medicine (NML-ERMED) Consortium is the flagship electronic resources consortium by the Directorate General of Health Services(DGHS) & Union Ministry of Health and Family Welfare, wherein access to 228 eJournals is being provided round the clock to 71 states and centrally funded Government Institutions including all All India Institute of Medical Science (AIIMS). Bhushan congratulated the NML for their expansion efforts and pointed out that the overall library scenario has changed nationally and globally post-pandemic.The prime focus of ERMED is helping medical colleges to comply with NMC guidelines, standardise care across all clinicians, reduce variability in care, enable safe patient care, drive appropriate drug use and prescribing behaviour, decrease medical errors, stop unnecessary diagnostic testing, shorten length-of-stay, lower mortality rates, exposure to the latest research, information development, scientific and technological progress. ERMED consortium would expand the research output and the ranking of the member institutions in this process. The Government of India has provided the financial support required for access to electronic journals under the NML-ERMED consortium project. ERMED members have access to advanced clinical tools and resources published by well-known publishers for benefit of faculty members and students. The official website of NML-ERMED(http://www.ermed.in/) and booklet were also launched at the event.   ]]> https://biospectrumindia.com/news/22/21788/india-approves-corbevax-as-first-heterologous-covid-19-booster-shot-for-18.html https://biospectrumindia.com/news/22/21788/india-approves-corbevax-as-first-heterologous-covid-19-booster-shot-for-18.html Thu, 11 Aug 2022 10:00:00 +0530 Hyderabad-based Biological E has announced that its COVID-19 vaccine CORBEVAX has been approved by the Union Health Ministry as a heterologous COVID-19 booster dose under emergency use authorization for individuals aged 18 years and above after six months of administration of primary vaccination (two doses) of COVAXIN or COVISHIELD vaccine.   The Union Health Ministry's approval is based on the recommendations made recently by the COVID-19 Working Group of the National Technical Advisory Group on Immunisation (NTAGI). This approval came after the Drug Controller General of India (DCGI) approved the vaccine for emergency use as a heterologous COVID-19 booster dose for individuals aged 18 years on June 4, 2022. CORBEVAX had received emergency use authorization as a primary two-dose vaccination regimen in adults, adolescents and children five years and above, in a series of approvals from December’21 to April’22.    The price of CORBEVAX for private COVID-19 vaccination centres is Rs 250, inclusive of GST. For the end-user, the price is Rs 400, including taxes and administrative charges. ]]> https://biospectrumindia.com/news/22/21764/aimed-writes-to-pm-for-separate-medical-devices-dept.html https://biospectrumindia.com/news/22/21764/aimed-writes-to-pm-for-separate-medical-devices-dept.html Fri, 05 Aug 2022 18:45:00 +0530 The Association of Indian Medical Device Industry (AiMeD) on behalf of the Indian Medical Device Industry has written to Prime Minister (PM) Narendra Modi requesting a Department of Medical Devices and a Ministry of Life Sciences / Healthcare Products.    Highlighting the urgent need for a separate department for medical devices, the letter from AiMeD requested the PM to change the name of the Department of Pharmaceuticals (DoP) to Department of Pharmaceuticals & Medical Devices or to have a separate Department of Medical Devices so that, the manufacturers will be assured that the government is taking this sector seriously as medical devices are not pharmaceuticals, though both may be medical products. The current name reflects the focus on the mature sector of pharmaceuticals and the ignored 80 per cent import-dependent sector of medical devices.   The current team needs to be supported with the required expertise by at least four persons i.e. one each from a background in Medical, BioMedical Engineering, Product Development & Marketing with experience from DST / DBT / BIRAC / DHR / MOH&FW / BCIL / NHSRC / EEPC / IBEF may be considered, said the letter.   The remodelled department will facilitate the creation and development of clusters for medical devices, creation of laboratories and service centres under PPP & Skill Development of Personnel in the field of manufacturing, sales, service and regulations.   The letter suggested that the department could be placed in the Ministry of Health as its extension with a Ministry of Health Care Products or Ministry of Life Sciences.   ]]> https://biospectrumindia.com/news/22/21756/govt-to-launch-new-portal-to-expedite-2025-goal-of-tb-elimination-in-india.html https://biospectrumindia.com/news/22/21756/govt-to-launch-new-portal-to-expedite-2025-goal-of-tb-elimination-in-india.html Thu, 04 Aug 2022 16:55:00 +0530 The United States Agency for International Development (USAID), in collaboration with the Karnataka Health Promotion Trust (KHPT), the National Tuberculosis (TB) Elimination Programme, and the Global Coalition Against TB, organised a critical consultation intended to aid national efforts to achieve Prime Minister Modi’s goal of a TB-free India by 2025. The conference, titled 'National Consultation on TB Elimination: Building Synergies for a TB Mukt Bharat (TB Free India)' brought together key stakeholders including members of Parliament, members of the Legislative Assemblies, Panchayati Raj Leaders, technical experts, and civil society to discuss different topics centred around eliminating TB.Dr Mansukh Mandaviya, Union Minister for Health and Family Welfare, gave the inaugural address in which he highlighted that health must be a priority if we need to progress and ensure that socio-economic development is achieved. He announced that a new portal would be launched that could make this a reality. It captures detailed information on TB-related data of the entire county and would be accessible to all. Here an individual could “adopt” a TB patient and take care of their treatment and nutrition. “If each one of us adopts one or several patients the goal of 2025 will quickly be realized,” he said. ]]> https://biospectrumindia.com/news/22/21737/health-ministry-proposes-new-draft-guidelines-for-drugs-medical-devices-and-cosmetics-bill-2022.html https://biospectrumindia.com/news/22/21737/health-ministry-proposes-new-draft-guidelines-for-drugs-medical-devices-and-cosmetics-bill-2022.html Mon, 01 Aug 2022 11:00:00 +0530 The Union Health Ministry is in the process to revise the outdated Drugs and Cosmetics Act of 1940 with an updated one where the focus will be more on laying down strict regulatory guidelines to keep pace with changing needs and technology. The ministry has called for suggestions, comments and objections from various stakeholders.The bill proposes new definitions for clinical trials, over-the-counter drugs, manufacturers, medical devices, new drugs, bioavailability studies, investigational new drugs and imported spurious drugs, among others. It seeks to bring in regulations for online pharmacies and medical devices and penalties such as imprisonment and compensation in case of injury or death during clinical trials for drugs.The draft also proposes that no clinical trial can be carried out without permission, medical management and compensation for injury or death, the draft proposes. The bill further mentions that no person shall himself or by any other person on his behalf sell, stock or exhibit or offer for sale or distribute any drug by online mode (e-pharmacy) except under and following a licence or permission issued in such manner as may be prescribed.The Centre has proposed a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB). Other than officials from the health ministry, the board will also include people from the department of atomic energy, department of science and technology, Ministry of Electronics, DRDO, and experts in the field of biomedical technology, biomaterials, and polymer technology. The draft proposes to allow the Centre to waive the requirement of conducting a clinical investigation for the manufacture or import of a new medical device in the public interest.It proposes medical device testing centres on the lines of drug laboratories in states and at the central level and states that medical management and compensation have to be provided to persons who are injured while participating in such trials. And, in case of death, the legal heir of the participant should be awarded compensation.The Bill proposes that the Central government must come up with rules to regulate the online sale of drugs and for online pharmacies to operate “following a licence or permission issued”. The Bill also includes a chapter on Ayurveda, Siddha, Sowa-Rigpa, Unani and Homeopathy, and their respective Drug Technical Advisory Boards. ]]> https://biospectrumindia.com/views/22/21719/how-deep-runs-the-rot-in-the-pharma-sector.html https://biospectrumindia.com/views/22/21719/how-deep-runs-the-rot-in-the-pharma-sector.html Sat, 30 Jul 2022 00:00:00 +0530 Public health is in limbo and the ‘Pharmacy of the World’ tag for India is in real distress with the latest happenings in India’s pharma sector. Things unfolded recently with the Central Bureau of Investigation (CBI) arresting a top executive of Biocon Biologics, a drugs inspector and a joint drug controller for alleged corruption. According to media reports, several people have been booked over alleged bribes to get approval for insulin injections for diabetes patients developed by Biocon. Biocon, however, came up with clarifications to protect itself and tried to come out clean. The National Stock Exchange (NSE) has sought clarification from Biocon concerning the firm's subsidiary being caught by the CBI for allegedly offering bribes to waive-off a trial of a new drug, according to media reports.  Recently, Micro Labs’ offices were raided by the Income Tax Department for tax evasion. It is notable that it is the same company which provided life-saving Dolo-650 during the COVID-19 pandemic. In this case, however, there was no reaction from the company. All these happenings have put to question how the regulatory body works and the in-depth corruption that is happening across the pharma sector. Corruption in the pharma sector is nothing new and the recent episode has opened a can of worms where pharma regulatory agencies are hand in glove with pharma companies on various occasions. It may be noted that nine years ago, in 2013, the Parliamentary Standing Committee on Health in its 118-page report found lapses in the way Central Drugs Standard Control Organisation (CDSCO) functions and blamed the department citing incidences of lapses, irregularities, and opaqueness. According to the committee, it is of the firm opinion that most of the ills besetting the system of drug regulation in India are mainly due to the skewed priorities and perceptions of CDSCO. Dinesh Thakur, Founder, Thakur Family Foundation, a pharma crusader and a whistleblower, who worked with Ranbaxy and eventually exposed frauds within the company, says, “Regulatory capture, when it comes to the pharma industry, is not a new phenomenon. It exists both in India and worldwide. However, the level of capture is by far an order of magnitude worse in India compared to elsewhere.” Some pharma companies indulge in giving gifts, cash, and paying for trips to attend medical conferences. This is done to potentially influence a doctor to be favourably inclined to prescribe the company's products. Says Girdhar Balwani, Professional Mentor & Independent Director, Cadila Pharmaceuticals said, “All companies and doctors have to operate within the legal domain of the country. While various laws and codes exist, it is important to look at the best way to ensure compliance. The Prevention of Corruption Act prescribes that corporate entities have compliance procedures in place to prevent their employees from engaging in any act which may be categorised as corruption or bribery. Subsidiaries of foreign companies have to also adhere to the applicable laws of the jurisdiction where the parent company is located.”   Instances Recently the Supreme Court has asked the Centre to file an affidavit on a plea alleging unethical marketing practices by pharmaceutical companies in their dealings with healthcare professionals resulting in the prescription of excessive or irrational drugs and a push for high-cost or over-priced brands. The plea was filed by the Federation of Medical & Sales Representatives Association of India (FMRAI) seeking a Uniform Code of Pharmaceutical Marketing Practices (UCPMP) and making it effective by providing a monitoring mechanism, transparency, accountability as well as consequences of violations. The Hisar vigilance department recently arrested the deputy President of the Haryana State Pharmacy Council (HSPC) for bribing officials related to some registration-related activities.  An article published in Frontiers in Research Metrics and Analytics talks about ghost-management of medical research, a process by which industry representatives craft and publish research in the names of doctors and psychiatrists. There have been instances where the pharma industry's sponsorship of clinical trials have influenced the results, putting a question mark on evidence-based medicine.  The Pharma City in Telangana was also in the news when a Member of Parliament from the state met the Prime Minister of India regarding the cancellation of the permission granted for setting up of Pharma City due to some corruption.  Take for instance Ranbaxy. A few years back, the company, a pioneer in India’s generic medicines revolution, had to pay damages to the tune of $500 million to settle corporate fraud related to unethical production of medicines that compromised on quality.    Global corruption in pharma A few years back US-based China focussed SciClone Pharma had to cough out more than $12 million in fines, penalised by US prosecutors after violating the Foreign Corrupt Practices Act. Many years back, US-based Purdue Pharma was fined $600 million for misbranding its blockbuster painkiller drug, OxyContin. The recent one is the corruption charges against GlaxoSmithKline in China. The UK-based pharma giant was prosecuted by local authorities and was found guilty of bribing physicians and hospitals to promote products and subsequently the company paid $490 million in fines.  The recent opioid crisis in the US where over 50,000 people died due to overdose of drugs like oxycodone, fentanyl etc. as these were often overprescribed by giving inducement to doctors, is a classic example. Off-label promotion of a drug for an indication not approved by the US FDA is also another form of corruption.  Similarly in the UK, the National Health Service (NHS) which is often touted as a model healthcare system in Europe, reported losses due to frauds in 2016-17 to the tune of £ 1.25 billion per annum.   The way out Technology can play a huge role in preventing corruption in the pharma sector. Technologies such as Artificial Intelligence (AI) and blockchain, can help eliminate the loopholes which can lead to bribery/corruption and improve transparency and accountability within the industry. The faster AI and blockchain are implemented across the industry the more we can prevent certain corruption in the sector. Says Dr Ajit Dangi, President & CEO, Danssen Consulting, "Elimination of intermediaries by extensive use of digitisation is one way to reduce corruption as we have seen in the success of the centre's ‘Direct Benefit Transfer scheme. The Right to Information Act and Whistleblower policy are also other tools to reduce corruption. If the new drug approval process was fully digitised there would have been fewer chances of the recent example of approval of a new drug of Biocon by allegedly waving phase three trial by the Deputy DCGI (Drugs Controller General of India) for consideration, may not have happened.” The UCPMP guidelines and newly enacted the National Medical Commission Act 2019 may usher into a new era to clean up the rot in the healthcare industry. According to Gunjan Bhardwaj, Founder and CEO, Innoplexus, blockchain integration in the pharma industry will lead to lower drug development costs, efficient clinical trials and an effective and efficient system of secure spending, transparent data and more medicines for patients and consumers throughout the world.   Need for clampdown  There is much more to this menace and only strict regulations by the government will help to weed out the corruption. As it is known that officials from CDSCO, DCGI and some members of the pharma fraternity are well involved in these activities, more stringent laws may help in the long run. Putting the culprits behind bars will send a strong message to those who plan to indulge in such activities.  The Union Health Ministry is learnt to have been taking steps to improve compliance and crack down on corruption. There is news that the Centre has decided to introduce QR codes for ensuring authenticity and traceability for 300 common drug brands including analgesics, vitamins, diabetes and hypertension medicines etc. This step is aimed at preventing spurious drugs from getting into circulation. The health ministry has made necessary amendments to the Drugs Rules, 1945, to implement the rule. While weeding out corruption is a tall order, especially in the pharma industry, there needs to be a will to implement the 'checks and balances' already in place.  Sanjiv Das sanjiv.das@mmactiv.com    ]]> https://biospectrumindia.com/news/22/21695/govt-pushes-for-capacity-building-to-make-india-global-leader-in-good-laboratory-practice.html https://biospectrumindia.com/news/22/21695/govt-pushes-for-capacity-building-to-make-india-global-leader-in-good-laboratory-practice.html Tue, 26 Jul 2022 00:00:00 +0530 Secretary, Department of Science and Technology (DST), Dr S Chandrasekhar, has highlighted that with Government’s commitment and emphasis on further capacity building on Good Laboratory Practice (GLP) in the country, India is destined to be a global leader in the area. “On March 3, 2011, India received the status of full adherence to the Mutual Acceptance of Data (MAD), which gave global recognition to India’s non-clinical safety data by tremendously augmenting its credibility and acceptability across the globe,” said Dr Chandrasekhar at the opening meeting of the evaluation team from Organisation for Economic Co-operation and Development (OECD), which is visiting the country for On-Site Evaluation (OSE) of the procedures and practices of the National GLP Programme. The National GLP Compliance Monitoring Programme of India is implemented through the National GLP Compliance Monitoring Authority (NGCMA), under the administrative control of DST with Secretary, DST as its Chairman. Dr Chandrasekhar informed that currently 52 test facilities in the country have been certified by NGCMA as GLP Compliant, which includes 3 Government labs - NIPER (Mohali), Indian Institute of Toxicology Research, Lucknow and Central Drug Research Institute, Lucknow. “The spectrum of activities of Indian GLP testing facilities (TFs) is wide, involving ten types of chemicals/test items and nine areas of expertise. The National GLP programme has not only helped to build a network of GLP TFs in the country but also created a huge quantum of highly competent human resources,” he added. ]]> https://biospectrumindia.com/news/22/21674/karnataka-manipur-and-chandigarh-top-niti-aayogs-india-innovation-index-2021.html https://biospectrumindia.com/news/22/21674/karnataka-manipur-and-chandigarh-top-niti-aayogs-india-innovation-index-2021.html Thu, 21 Jul 2022 15:40:00 +0530 Karnataka, Manipur and Chandigarh have topped in their respective categories in the third edition of NITI Aayog’s India Innovation Index. The index was released by NITI Aayog Vice Chairman Suman Bery in the presence of Member Dr VK Saraswat, CEO Parameswaran Iyer and Senior Adviser Neeraj Sinha, and Institute for Competitiveness Chairman Dr Amit Kapoor.    While Karnataka has topped again in the ‘Major States’ category, Manipur is leading the ‘North East and Hill States’ category and Chandigarh is the top performer in the ‘Union Territories and City States’ category.   Prepared by NITI Aayog and the Institute for Competitiveness, the India Innovation Index is a comprehensive tool for the evaluation and development of the country’s innovation ecosystem. The third edition highlights the scope of innovation analysis in the country by drawing on the framework of the Global Innovation Index. The number of indicators has increased from 36 (in the India Innovation Index 2020) to 66 (in the India Innovation Index 2021). The indicators are now distributed across 16 sub-pillars, which, in turn, form seven key pillars. ]]> https://biospectrumindia.com/news/22/21670/indias-bioeconomy-at-80-b-in-2021-to-touch-300-b-by-2030.html https://biospectrumindia.com/news/22/21670/indias-bioeconomy-at-80-b-in-2021-to-touch-300-b-by-2030.html Thu, 21 Jul 2022 00:00:00 +0530 Releasing India’s Bioeconomy Report 2022, Dr Jitendra Singh, Union Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, pointed out that India’s Bioeconomy has reached over $80 billion in 2021 recording 14.1% growth over $70.2 billion in 2020. Noting the rapid growth in the sector, the Minister said, Bioeconomy is likely to touch 150 billion dollars by 2025 and over 300 billion dollars by 2030. According to the report, nearly a fifth of BioEconomy has been due to the Covid-19 vaccination and testing drive. The Covid-19 Bioeconomy was $14.56 billion in 2021. Covid-19 vaccines accounted for $8.7 billion in value, while testing accounted for $5.9 billion.  BioPharma still accounts for the largest share of the BioEconomy. BioPharma accounted for 49 percent share of the BioEconomy. The total economic contribution of this segment was estimated at $39.4 billion. Diagnostics accounted for 52.8% share of the total BioPharma Market, while Therapeutics segment stood at 26%. The Biotherapeutics segment is estimated to record $1.05 billion in value. The diabetes, oncology, infections, and cardiology medication are the primary contributors. The BioIndustrial segment’s contribution to the BioEconomy witnessed 202 percent growth in 2021. The segment is estimated at $10.27 billion. The Biofuels contributed $5.97 billion in value. The other important sub-segment of BioIndustrial, the enzymes market reached $4.3 billion. The country also saw increased activity of start-up registrations. The cumulative number of start-ups in 2021 was estimated at 5365. About 1128 companies have registered in 2021. This is the highest number since year 2015. ]]> https://biospectrumindia.com/news/22/21661/govt-to-roll-out-pharma-schemes-focusing-on-msmes-clusters.html https://biospectrumindia.com/news/22/21661/govt-to-roll-out-pharma-schemes-focusing-on-msmes-clusters.html Tue, 19 Jul 2022 17:40:00 +0530 Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Govt of India is planning to roll out a series of initiatives under the banner of Schemes for ‘Strengthening Pharmaceuticals Industry’ (SPI). Keeping in view the strategic role of medium and small sized enterprises (MSMEs), who provide important forward and backward linkages to the industry, and also keeping in view that MSMEs tend to grow in clusters, these schemes shall address the issues of technology upgradation at both unit level and cluster level. The government shall be incentivising the intending MSME units going in for acquire Schedule M certification or WHO GMP Certification through the sub-scheme Pharmaceuticals Industry Technology Upgradation Assistance Scheme (PTUAS). The MSME unit shall have the option to choose from either Capital subsidy or Interest subvention. At the cluster level, the sub-scheme ‘Assistance to Pharmaceuticals Industry for Common Facilities’ (APICF) envisages supporting the creation of common facilities like testing labs, common effluent treatment plants and other such common facilities by providing government support in the form of a capital grant to the extent of up to 70 per cent subject to a ceiling of a maximum of Rs 20 crore. The third sub-scheme proposes to conduct a series of awareness programmes, conduct sectoral studies and organise similar such programmes to generate soft inputs for policy advocacy. ]]> https://biospectrumindia.com/news/22/21633/govt-issues-advisory-to-e-commerce-platforms-selling-ayurvedic-drugs.html https://biospectrumindia.com/news/22/21633/govt-issues-advisory-to-e-commerce-platforms-selling-ayurvedic-drugs.html Thu, 14 Jul 2022 19:35:00 +0530 The Central Consumer Protection Authority (CCPA), under Ministry of Consumer Affairs, Government of India, has issued an advisory to e-commerce entities concerning the sale of Ayurvedic, Siddha and Unani drugs containing ingredients listed in Schedule E (1) of the Drugs and Cosmetics Rules, 1945.    E-commerce platforms have been advised that the sale or facilitating of the sale of such drugs shall be done only after a valid prescription of a registered Ayurveda, Siddha or Unani practitioner respectively is uploaded by the user on the platform. Consuming such drugs without medical supervision can lead to severe health complications.    As per Rule 161(2) of the Drugs and Cosmetics Rules, 1945, the container of a medicine for internal use for the treatment of human ailments shall, if it is made up of a substance specified in Schedule E (1), be labelled conspicuously with the words “Caution: To be taken under medical supervision” both in English and Hindi language.       ]]> https://biospectrumindia.com/news/22/21611/icmr-unveils-national-registry-of-multiple-sclerosis.html https://biospectrumindia.com/news/22/21611/icmr-unveils-national-registry-of-multiple-sclerosis.html Wed, 13 Jul 2022 10:25:00 +0530 The Indian Council of Medical Research (ICMR) has taken an initiative to set up a national registry of Multiple Sclerosis (MS)- Indian Multiple Sclerosis and Allied Demyelinating Disorders Registry and Research Network (IMSRN). It is the first Indian nationwide dedicated database research network of MS and allied demyelinating disorders. The registry will create an organised system for data collection, storage, retrieval, analysis, management and outcomes. The IMSRN (www.imsrn.icmr.org.in), was started in October 2021, with AIIMS New Delhi as the national coordinating centre and 24 participating centres spread across the country.The inauguration of the registry was presided over by Professor Dr Subrata Sinha, Dean Academics of AIIMS, New Delhi and Dr Satish Chandra, former Director, NIMHANS, Bengaluru. It is estimated that the MS affects about 20 persons per lakh populations and neuromyelitisoptica spectrum disorders (NMOSD) affects about 2.7 per lakh population although this may be an underestimation. ]]> https://biospectrumindia.com/news/22/21606/mtai-urges-govt-not-to-levy-tds-on-free-medical-samples-provided-to-docs.html https://biospectrumindia.com/news/22/21606/mtai-urges-govt-not-to-levy-tds-on-free-medical-samples-provided-to-docs.html Tue, 12 Jul 2022 13:45:00 +0530 Medical Technology Association of India (MTaI) has urged the government to reconsider its recently introduced Tax Deducted at Source (TDS) provision on free medical samples provided to doctors. Taxation on these samples will adversely affect hands-on training for doctors and clinicians and therefore impact patient's access to life-saving and life-enhancing technologies.   MTaI has also urged the government not to consider the expenses incurred on doctors’ (trainees) travel and stay for product training and application usage as doctors’ income because they (doctors) are often required to travel mainly due to difficulties in mobilising medical devices and equipment. Thus, TDS should not be levied on such expenses.   MTaI has already written to the concerned authorities highlighting the concerns of the industry.   As per the provisions, free medical samples provided to doctors, reimbursement of out-of-pocket expenses incurred by healthcare professionals and expenditure about dealer or customer business conferences would be treated as a benefit and therefore be subject to TDS deduction.   ]]> https://biospectrumindia.com/news/22/21593/strengthen-industry-academia-linkages-through-pharma-research-policy-dr-mansukh-mandaviya.html https://biospectrumindia.com/news/22/21593/strengthen-industry-academia-linkages-through-pharma-research-policy-dr-mansukh-mandaviya.html Fri, 08 Jul 2022 19:25:00 +0530 The PHD Chamber of Commerce and Industry (PHDCCI) recently organised the Pharma Med HD conference at PHD House, New Delhi. Dr Mansukh Mandaviya, Union Minister for Chemicals & Fertilizers and Health & Family Welfare, Government of India, said that the government is putting together an accessible and affordable healthcare ecosystem for the citizens of the country. The government is coming up with certain initiatives like a pharma research policy to uplift industry-academia linkages to magnify research in this area which will bring immediate solutions to the problems.Dr Ram Sewak Sharma, CEO, National Health Authority, briefed about some important uses and benefits of schemes and applications made for an affordable healthcare system. He talked about Unified Health Interface which is created for teleconsultation, record management; data sharing and also it will help a person to find a particular doctor or any drug through a verified registry of doctors and drugs respectively.Pradeep Multani, President, PHDCCI, mentioned that the healthcare industry in India is projected to reach $372 billion by 2022 consisting of hospitals, medical devices, clinical trials, outsourcing, telemedicine, medical tourism, health insurance, and medical equipment. Several factors are driving the growth of the Indian healthcare sector including an ageing population, a growing middle class, the rising proportion of lifestyle diseases, an increased emphasis on public-private partnerships as well an accelerated adoption of digital technologies, including telemedicine, besides heightened interest from investors and increased FDI inflows over the last two decades. Saurabh Sanyal, Secretary-General, PHDCCI, presented a formal vote of thanks and deliberated the session in session in which he said that as India heads toward its centenary year of independence, it is time to reflect on the past milestones and chart out a roadmap for the future growth of the Indian healthcare sector. ]]> https://biospectrumindia.com/news/22/21555/autonomous-navigation-facility-opens-at-iit-h-for-unmanned-ground-and-aerial-vehicles.html https://biospectrumindia.com/news/22/21555/autonomous-navigation-facility-opens-at-iit-h-for-unmanned-ground-and-aerial-vehicles.html Mon, 04 Jul 2022 15:30:00 +0530 Union Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr Jitendra Singh inaugurated first-of-its-kind, state-of-the-art “Autonomous Navigation” facility to develop unmanned ground and aerial vehicles in the Indian Institute of Technology, Hyderabad (IIT-H) campus.    The Minister also interacted with startups developing unmanned ground motor vehicles like driver-less self-driven motor cars, driver-less self-driven bicycles etc., and unmanned aerial vehicles including drones in different shapes and sizes. Unmanned aircraft vehicles including drones can be used for various healthcare purposes.   Funded by the Union Ministry of Science & Technology at a budget of Rs 130 crore, the “Technology Innovation Hub on Autonomous Navigation” is a multidisciplinary initiative, which will make India a global player in the futuristic and next-generation “Smart Mobility" technology.           ]]> https://biospectrumindia.com/news/22/21520/cabinet-approves-mou-between-india-singapore-for-tech-innovations.html https://biospectrumindia.com/news/22/21520/cabinet-approves-mou-between-india-singapore-for-tech-innovations.html Wed, 29 Jun 2022 18:00:00 +0530 The Union Cabinet chaired by Prime Minister Narendra Modi was apprised of a Memorandum of Understanding (MoU) signed between the Department of Science and Technology of the Republic of India and the Ministry of Trade and Industry of the Government of the Republic of Singapore on Cooperation in the fields of Science, Technology and Innovation. The MoU was signed in February 2022.   The MoU will provide a mechanism and help in creating an ecosystem that will promote innovation and entrepreneurship in both countries leading to new technology creation, manpower training and IP generation through collaboration.   The new knowledge and technology development through activities implemented under this cooperation will provide impetus to Atmanirbhar Bharat. The MoU will provide a mechanism and help in creating an ecosystem that will promote innovation and entrepreneurship in both countries leading to new technology creation, manpower training and IP generation through collaboration. The activities envisaged in the MoU will involve product development and technology exchange which may lead to the generation of new enterprises and employment.   The objective of this Memorandum is to encourage, develop and facilitate cooperation between India and Singapore in fields of common interest in science, technology and innovation.  ]]> https://biospectrumindia.com/news/22/21516/indias-first-mrna-covid-19-vaccine-gets-emergency-use-authorization.html https://biospectrumindia.com/news/22/21516/indias-first-mrna-covid-19-vaccine-gets-emergency-use-authorization.html Wed, 29 Jun 2022 00:00:00 +0530 Pune-based Gennova Biopharmaceuticals, a subsidiary of Emcure Pharmaceuticals, has announced that its mRNA vaccine – GEMCOVAC-19 - has received the Emergency Use Authorization (EUA) from the office of the Drugs Controller General of India (DCGI). GEMCOVAC-19 is the very first mRNA vaccine developed in India and only third mRNA vaccine to be approved for COVID-19 in the world.  Gennova’s GEMCOVAC-19 has reached the primary end point of the Phase III clinical trial. The clinical data was evaluated by the Central Drugs Standard Control Organisation (CDSCO). The vaccine was found to be safe, well-tolerated and immunogenic. Gennova Biopharmaceuticals aims to produce around 40 - 50 lakhs of doses per month and this capacity can be quickly doubled. Beyond India, Gennova aims at providing sustainable access to low-and middle-income countries around the world to the vaccine to blunt the spread of pandemic. ]]> https://biospectrumindia.com/news/22/21491/centre-allocates-rs-404-cr-to-tn-for-medical-infrastructure-advancement-.html https://biospectrumindia.com/news/22/21491/centre-allocates-rs-404-cr-to-tn-for-medical-infrastructure-advancement-.html Mon, 27 Jun 2022 10:15:00 +0530 Union Minister for Health and Family Welfare Dr Mansukh Mandaviya during his two-day visit to Tamil Nadu (TN) and Puducherry, visited the Tamil Nadu Government Multi Super Speciality Hospital in Chennai.   Dr Mandaviya informed that the Central Government has allocated more than Rs 2600 crore for the health of Tamil Nadu under National Health Mission and Rs 404 crore for medical infrastructure advancement under the Pradhan Mantri Ayushman Bharat Health Infrastructure Mission.   Dr Mandaviya also virtually laid the foundation stone of CGHS Wellness Centre and Lab at Avadi.    Informing that the Central Government will soon launch the ‘ One Nation, One Dialysis’ programme, under the Pradhan Mantri National Dialysis Programme, Dr Mandaviya said through this scheme, any patient can get a dialysis facility from anywhere in the country. ]]> https://biospectrumindia.com/news/22/21429/mohfw-launches-intensified-diarrhoea-control-fortnight-2022.html https://biospectrumindia.com/news/22/21429/mohfw-launches-intensified-diarrhoea-control-fortnight-2022.html Mon, 13 Jun 2022 19:30:00 +0530 Union Minister of State for Health and Family Welfare, Dr Bharati Pravin Pawar launched the Intensified Diarrhoea Control Fortnight (IDCF)-2022 in the presence of Dr Sapam Ranjan Singh, Health Minister of Manipur. IDCF programme is being implemented till June 27, 2022, in the states/UTs. The goal of IDCF is to attain zero child deaths due to childhood diarrhoea. IDCF consists of a set of activities to be implemented in an intensified manner for the prevention and control of deaths due to dehydration from diarrhoea across all states and UTs. These activities mainly include intensification of advocacy and awareness generation activities for diarrhoea management, strengthening service provision for diarrhoea case management, the establishment of ORS-Zinc corners, and prepositioning of ORS by ASHA in households with under-five children and awareness generation activities for hygiene and sanitation.One of the main activities under the IDCF programme has been the activities by field workers including ASHA, ANM and Anganwadi workers. Field workers visit the homes of families with children below five years of age and provide counselling in case of diarrhoea for the distribution of zinc and ORS sachets. They also promote sanitation practices, and breastfeeding practices and advise on the preparation method of ORS through group meetings among mothers. ]]> https://biospectrumindia.com/news/22/21427/nha-nasscom-conclave-2022-discuss-ways-to-revolutionise-health.html https://biospectrumindia.com/news/22/21427/nha-nasscom-conclave-2022-discuss-ways-to-revolutionise-health.html Mon, 13 Jun 2022 17:25:00 +0530 The National Health Authority (NHA) and NASSCOM (National Association of Software and Service Companies) recently organised the NHA-NASSCOM Conclave 2022 on Ayushman Bharat Digital Mission – Revolutionizing Digital Health. The conclave was held in Bengaluru as a hybrid event with the participation of over 400 stakeholders and industry veterans from the healthcare and technology sector as well as the investor community in India in physical/ virtual mode. The chief guest for the event was Minister of Health & Family Welfare, and Medical Education, Government of Karnataka - Dr K Sudhakar.Speaking on the vision behind the Ayushman Bharat Digital Mission (ABDM), Dr RS Sharma, CEO, NHA said, “The Ayushman Bharat Digital Mission aims to replicate this success in healthcare delivery by building an equitable, accessible and inclusive ecosystem that rides on collaborative efforts of the government and private sector."The conclave also saw a special address by Jawaid Akhtar, Additional Chief Secretary to Govt of Karnataka, Health & Family Welfare Services on the importance of improving healthcare through digital innovations. Dr Praveen Gedam, Additional CEO, NHA and Mission Director for ABDM elaborated on the opportunities this programme presents for the entire ecosystem.NASSCOM played a key role in gathering thought leaders from the health and technology sector for panel discussions on how to drive usage of digital health and the role of innovators in the digital health stack. The panellists included heads of health tech organisations in India like Arthur D Little India, Manipal Hospitals, Bill & Melinda Gates Foundation, Royal Philips, Indegene, Quadria Capital, Medi Assist, Tata Elxsi, Narayana Health, DRiefcase, CrelioHealth, Plus91 and EkaCare. ]]> https://biospectrumindia.com/news/22/21411/assam-cm-inaugurates-technology-incubation-centre-of-guwahati-biotech-park.html https://biospectrumindia.com/news/22/21411/assam-cm-inaugurates-technology-incubation-centre-of-guwahati-biotech-park.html Fri, 10 Jun 2022 17:15:00 +0530 Chief Minister of Assam Dr Himanta Biswa Sarma recently inaugurated the Technology Incubation Centre of Guwahati Biotech Park at Amingaon, Guwahati and Assam Biotech Conclave in the presence of Union Minister of Education, Dharmendra Pradhan and Minister, Science Technology and Climate Change, Assam Keshab Mahanta. Ranoj Pegu, Minister of Education, Assam, and Prof TG Sitharam, Director, IIT Guwahati were also present during the inauguration of the Technology Incubation Centre and Assam Biotech Conclave 2022.                   MoUs were exchanged between Guwahati Biotech Park and Numaligarh Refinery, CSIR –NEIST, Jorhat, Royal Global University, Guwahati, University of Science Technology and Management, Guwahati, Institute of Bio-resources and Sustainable Development, IASST Social Venture and Entrepreneurship Council, Atal Incubation Centre BIMTECH, Noida, NRDC and tripartite MoU amongst Guwahati Biotech Park, Association of Biotechnology Led Enterprises and Federation of Industry & Commerce of North Eastern Region for fostering innovation and entrepreneurship in North East and neighbouring states   Assam Biotech Policy, 2022-27 was also launched during the inaugural ceremony. The biotech policy focuses on developing biotech infrastructure, improving biotech education, research and innovation, advancement in technology and entrepreneurship support, developing the biotech industry, introducing business support cells, managing accreditations and quality certifications, single-window clearance through the nodal agency, North East Vision Group on Biotechnology, and Centre of Excellence in Bioinformatics & Applied Biotechnology.   Best Young Innovative Entrepreneur Award was presented to Sidharth Arora from IIT Roorkee, Best Young Women Entrepreneur Award to Dr Ananya Barman from Assam and Best Young Innovative entrepreneur award North East to Kaustoov Gopal Goswami from Assam.    Guwahati Biotech Park in association with the Indian Institute of Technology Guwahati hosted the two-day Assam Biotech Conclave 2022.    Dr Anil Gupta, Founder, Honey bee Network & SRISTI took a special session on Grassroot Innovations with Focus on North-East. A special session by Dr Nagaraja Prakasam, Partner, Acumen Fund was also a part of the two-day long conclave. Panel discussions were conducted on ‘Conundrum of Incubators in India’, ‘Ease of Doing Business for Start-ups’, ‘Decoding Mentorship for Startups’, ‘Smart Protein opportunities in India’, ‘Chasing Sustainability in Agri-tech’, ‘India at the cusp of Med-Tech Revolution’ and ‘Spirit of Entrepreneurship in Young India’ with industry experts and member of academia.    As a part of the conclave, Assam Bio-Innovation Fellowship (ABF) program was also launched by Guwahati Biotech Park. ABF is a highly competitive scheme instituted by the Assam Biotechnology Council (ABTC) under the Science, Technology and Climate Change Department, Government of Assam to recognise and reward scientists below the age of 55 with an excellent track record and have made significant scientific contributions in Biotechnology and allied areas. The winners are Ningombam Sanjib Meitei, Incubatee of Guwahati Biotech Park and Imnanaro, Research Scholar, IIT Guwahati. ]]> https://biospectrumindia.com/news/22/21392/national-ayurveda-research-institute-for-panchakarma-bags-nabl-accreditation.html https://biospectrumindia.com/news/22/21392/national-ayurveda-research-institute-for-panchakarma-bags-nabl-accreditation.html Wed, 08 Jun 2022 16:25:00 +0530 The Department of Biochemistry and Pathology of National Ayurveda Research Institute for Panchakarma (NARIP), Cheruthuruthy, Thrissur, Kerala has received NABL M(EL)T Accreditation for its clinical laboratory services. NARIP is one of the premier research institutes under the Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, Government of India. This is the first institute under CCRAS to get NABL (National Accreditation Board for Testing and Calibration Laboratories) accreditation for its clinical laboratory services.    Professor Rabinarayan Acharya, Director General, CCRAS recently inaugurated the NABL accredited lab during a programme held on this occasion in the presence of senior officials of the council. The programme was presided by Dr D Sudhakar, Director, NARIP. All the officials of the NARIP attended the inauguration programme.   The certification is provided by the National Accreditation Board for Testing & Calibration Laboratories (A Constituent Board of Quality Council of India). The accreditation of the laboratory ensures that citizens get quality healthcare service, especially for those residing in villages and small towns.    Members of scientific communities including those working on diverse research projects, outreach medical camps etc. also benefit from accredited labs. Dr N Thamizh Selvam, Assistant Director, Biochemistry informed that the laboratory is equipped with advanced instruments such as a fully automated biochemistry analyser, fully automated haematology analyser, and ELISA systems with periodical calibration.  ]]> https://biospectrumindia.com/news/22/21388/dbt-renews-mou-with-bill-melinda-gates-foundation.html https://biospectrumindia.com/news/22/21388/dbt-renews-mou-with-bill-melinda-gates-foundation.html Tue, 07 Jun 2022 00:00:00 +0530 The Department of Biotechnology (DBT) and the Bill & Melinda Gates Foundation have renewed the Memorandum of Understanding (MoU), originally signed in 2012, to support innovative approaches for developing new preventions, therapies and interventions needed to solve health (human and animal), food and nutritional inequities on 7th June 2022 in New Delhi. The renewed MoU pledged a combined $50 million investment to the joint initiative, to continue to explore and expand funding arenas and mechanisms to support innovators, focused on early-mid stage research and product development to tackle health and developmental issues. Dr. Rajesh S. Gokhale, Secretary, Department of Biotechnology, Ministry of Science and Technology, Govt. of India stated “Such partnerships bring together the best and the brightest by sharing and leveraging each partners strength and resources. The Grand Challenges India partnership exemplifies this, where the partners focus on identifying and funding affordable and innovative solutions to public health challenges not only within India but also for the developing world." The event also saw announcement of the latest open call for funding on Diagnostics for Neglected Tropical Disease (NTD)- Lymphatic Filariasis (LF). The call focuses on developing point-of-care, novel cost-effective diagnostics for lymphatic filariasis for use in national Lymphatic Filariasis elimination programs. The goal of this challenge is to have a reasonably inexpensive, durable and accurate point of care testing method(s) that can be used in developing/remote geographies.  ]]> https://biospectrumindia.com/news/22/21380/icmr-issues-guidelines-for-management-of-type-1-diabetes.html https://biospectrumindia.com/news/22/21380/icmr-issues-guidelines-for-management-of-type-1-diabetes.html Mon, 06 Jun 2022 00:00:00 +0530 The Indian Council of Medical Research (ICMR) has released guidelines for the management of type 1 diabetes in the country. The ICMR type 1 diabetes guidelines come at a time when the SARS-CoV-2 pandemic has disproportionately affected people with diabetes population, exposing them to a high risk for severe illness and mortality. The ICMR type 1 diabetes guidelines is a comprehensive document providing advice on care of diabetes in children, adolescents and adults with type 1 diabetes. All chapters in this guideline have been provided with formation to reflect advances in scientific knowledge and clinical care that have occurred in the recent past. The guidelines focus on several aspects related to diabetes such as epidemiology, lifestyle, drugs, monitoring, complications, education etc. There are still formidable challenges in providing equitable treatment to everyone with type 1 diabetes in the world and India is no exception to this. It is hoped that with improved diabetes control, the dreaded complications of diabetes like blindness, kidney failure, amputations, heart attacks and stroke, not to mention diabetic ketoacidosis, impotence and painful neuropathy can all be reduced, if not totally eliminated. ]]> https://biospectrumindia.com/news/22/21361/icmr-issues-guidance-document-for-use-of-drones-in-healthcare.html https://biospectrumindia.com/news/22/21361/icmr-issues-guidance-document-for-use-of-drones-in-healthcare.html Thu, 02 Jun 2022 00:00:00 +0530 The Indian Council of Medical Research (ICMR) has announced the release of their ‘Guidance Document for use of Drones in Healthcare’. The institute has published this document based on the field experience from Manipur and Nagaland. The scientists from ICMR collaborated with Ministry of Civil Aviation (MoCA), Government of India, Directorate General of Civil Aviation (DGCA), Airport Authority of India (AAI) to produce this document in compliance with the New drone Rules-2021 which highlights the ways of selecting drones, choosing takeoffs and landing sites etc. Medical items such as measles, mumps, Covid-19 vaccines with storage temperature between 2°C to 8°C, tablets and capsules, syrups in bottles, gloves, syringes, blood bags, diagnostic biological tissues, urine, blood, sputum, saliva or frozen specimens can only be transported following this guidance. The objective of this document covers areas such as how to obtain regulatory approvals from competent authorities for various kinds of drones and utilising air space for delivering medical supplies restricted to medicines, vaccines and surgical materials. Identification of healthcare workers at the distribution centres and district hospitals is a critical part of drone based delivery planning as they will be managing the transfer of supplies and packaging, in coordination with the drone pilots. ]]> https://biospectrumindia.com/news/22/21352/health-ministry-issues-guidelines-on-management-of-monkeypox-disease.html https://biospectrumindia.com/news/22/21352/health-ministry-issues-guidelines-on-management-of-monkeypox-disease.html Wed, 01 Jun 2022 00:00:00 +0530 In view of the increasing reports of Monkeypox (MPX) cases in non-endemic countries, as part of a proactive and risk-based approach for management of Monkeypox and to ensure advance preparedness across the country, Union Ministry of Health and Family Welfare has issued ‘Guidelines on Management of Monkeypox Disease’. There are no reported cases of monkey pox disease in India, as on date. As per the Guidelines, a confirmed case is laboratory confirmed for monkeypox virus by detection of unique sequences of viral DNA either by polymerase chain reaction (PCR) and/or sequencing. All the clinical specimens should be transported to the Apex Laboratory of ICMR-NIV (Pune) routed through the Integrated Disease Surveillance Programme (IDSP) network of the respective district/state. The Guidelines on Management of Monkeypox Disease include epidemiology of the disease including host, incubation period, period of communicability and mode of transmission; contact and case definitions; clinical features and its complication, diagnosis, case management, risk communication, guidance on Infection Prevention and Control (IPC) including use of personal protective equipment The guidelines stresses on surveillance and rapid identification of new cases as the key public health measures for outbreak containment, mandating need to reduce the risk of human-to-human transmission. It explains the Infection Prevention and Control (IPC) measures, IPC at home, patient isolation and ambulance transfer strategies, additional precautions that needs to be taken care of and duration of isolation procedures.     ]]> https://biospectrumindia.com/news/22/21347/entod-pharma-bags-dcgi-nod-for-phase-iii-trial-of-0-05-atropine-eye-drops.html https://biospectrumindia.com/news/22/21347/entod-pharma-bags-dcgi-nod-for-phase-iii-trial-of-0-05-atropine-eye-drops.html Tue, 31 May 2022 00:00:00 +0530 ENTOD Pharmaceuticals has now got the approval to carry out phase 3 trials across India for their 0.05 per cent atropine eye drops from the Drugs Controller General of India (DCGI).   This higher strength of low-dose atropine eye drops is not available commercially anywhere in the world, and Mumbai-based ENTOD Pharmaceuticals would be the first company to launch this in India subject to a successful demonstration of safety and efficacy in clinical studies.   MYATRO 0.01 per cent eye drops are used to treat eye problems like myopia, especially in children when a child can see nearby objects but has problems seeing distant objects. Low-dose atropine has emerged as an effective approach to slow the progression of myopia in children and has recently garnered a lot of interest from ophthalmologists.  ]]> https://biospectrumindia.com/news/22/21344/nha-launches-online-public-dashboard-for-abdm.html https://biospectrumindia.com/news/22/21344/nha-launches-online-public-dashboard-for-abdm.html Mon, 30 May 2022 17:30:00 +0530 The National Health Authority (NHA) under its flagship scheme of Ayushman Bharat Digital Mission (ABDM) has launched a public dashboard for near real-time information on the scheme. The ABDM public dashboard displays detailed information on the core registries under the mission – Ayushman Bharat Health Account (ABHA) numbers, Healthcare Professionals Registry (HPR) and Health Facility Registry (HFR).    All stakeholders can easily access the ABDM public dashboard from the ABDM website or directly here: https://dashboard.abdm.gov.in/abdm/. The dashboard captures data related to the number of ABHA generated, the number of healthcare professionals like doctors, nurses etc. registered, and digital health records linked with ABHA. The dashboard also has granular details concerning the number of health facilities like hospitals, laboratories etc. registered daily as well as cumulative to date. Also, partner-wise data of ABHA generation created and digital health records linked are made available on the dashboard in real-time. This data is further broken down into several key components that give updates on the scheme’s progress in specific areas.   For Health Facility Registry, the dashboard presents the data in infographics format based on ownership (government or private), systems of medicine (Modern Medicine - Allopathy, Ayurveda, Sowa- Rigpa, Physiotherapy, Unani, Dentistry, Siddha, Homeopathy etc.) and state-wise facilities registered under the ABDM. Similarly, for the HPR, the dashboard shows the data segregation on basis of their employment type - government or private sector, systems of medicine and the states/ UT from where the applications have been received.    Besides the detailed information available on the ABDM public dashboard, the main ABDM website (https://abdm.gov.in/) has a section with all the numbers concisely. Also, the ABDM sandbox portal has a dashboard section (https://sandbox.abdm.gov.in/applications/Integrators) that shares details of the integrators/ health tech service providers/ apps that have already integrated with ABDM and are registered as ABDM partners.    ]]> https://biospectrumindia.com/news/22/21266/govt-launches-national-emergency-life-support-courses-for-healthcare-workers.html https://biospectrumindia.com/news/22/21266/govt-launches-national-emergency-life-support-courses-for-healthcare-workers.html Wed, 18 May 2022 17:00:00 +0530 Union Minister of State for Health and Family Welfare, Dr Bharati Pravin Pawar has launched National Emergency Life Support (NELS) courses for doctors, nurses and paramedics.   Apart from the training modules, the programme also includes developing training infrastructure in all States/UTs to implement the NELS course and creating a cadre of trainers to train doctors, nurses and paramedics working in emergency departments of the hospitals and ambulance services.   The Minister has requested the states to send proposals for establishing NELS Skill Centres at their medical colleges and urged all skill centres to ensure that training is not only operationalised but also utilised to the maximum extent to improve the quality of emergency care services in the State. She also requested Disaster Management Cell to regularly interact with participating institutions and monitor their activities to make this a successful initiative.   The activities under the NELS entail developing emergency life support training modules for doctors, nurses and paramedics after experts’ consultations and based on the Indian context, setting up and equipping skill centres in medical colleges under Center/States to impart skill-based training on emergency life support for all categories of health functionaries, 120 skills centres to be established under SFC (FY: 2021-26) (out of which 90 skill centres are in various stage of development). The initiative will lead to the creation of a pool of trained doctors, nurses and paramedics in the country with skills to provide standardised emergency life support and reduce mortality due to medical emergencies.     ]]> https://biospectrumindia.com/news/22/21263/union-health-minister-releases-ab-hwc-assessment-report-in-18-states.html https://biospectrumindia.com/news/22/21263/union-health-minister-releases-ab-hwc-assessment-report-in-18-states.html Wed, 18 May 2022 10:40:00 +0530 Dr Mansukh Mandaviya, Union Minister for Health and Family Welfare, released the findings of a third party assessment of Ayushman Bharat – Health and Wellness Centres (AB-HWC) in 18 states of India, in the presence of Dr Vinod Paul, Member (Health), NITI Aayog and Rajesh Bhushan, Union Health Secretary, in New Delhi.   Appreciating the findings of the report, Dr Mandaviya stated, “Third party evaluation is important for proper assessment of the functioning and implementation of the scheme."   The assessment of AB-HWCs in 18 states has been done in two phases by non-governmental entities, GRAAM and JHPIEGO as well as AIIMS, New Delhi from the government sector for the year 2020-21.   The following are the key findings of the report:  The launch of AB-HWC has enabled translation of the vision of moving from selective to comprehensive primary health care package enunciated in the National Health Policy 2017. The implementation of AB-HWC scheme is on track in most states with a clear roadmap for achieving targets set for December 2022. Overall, there has been an improvement in equity in access, despite existing constraints such as infrastructure availability and status of peripheral health facilities. Effective communication was noted from district to PHC-HWC and SHC-HWC resulting in translation of policy decisions into action, faster and better. Client satisfaction with the services provided was much higher among those who received services from HWCs as compared to those who received services from non-HWCs across all the four parameters measured – treatment, medicines, diagnostics and cleanliness. The Evaluation also brought out requirement of a definite timeline for rolling out all the services packages. The timelines have now been fixed.       ]]> https://biospectrumindia.com/news/22/21224/oman-to-fast-track-approval-of-indian-pharma-products-registered-by-us-fda-ukmhra-ema.html https://biospectrumindia.com/news/22/21224/oman-to-fast-track-approval-of-indian-pharma-products-registered-by-us-fda-ukmhra-ema.html Thu, 12 May 2022 10:40:00 +0530 The 10th Session of the India-Oman Joint Commission Meeting (JCM) discussed on fast tracking of approvals for the registration of Indian pharmaceutical products already registered by US FDA, UKMHRA and EMA.   The meeting was co-chaired by Piyush Goyal, Union Minister of Commerce & Industry, Consumer Affairs, Food & Public Distribution and Textiles, Government of India and Qais bin Mohammed al Yousef, Minister of Commerce, Industry and Investment Promotion of the Sultanate of Oman, who is in India now with a 48-member delegation comprising senior officials and business leaders.   A joint release of a Market Research Report commissioned by the Embassy of India, Muscat on the pharmaceutical sector in Oman highlighted strategies and opportunities for Indian companies in Oman in this sector.   Discussions were held on all Memorandum of Understanding (MoUs)/ Agreements under discussion, including standards and metrology, India-Oman Double Taxation Avoidance Agreement, India-Oman Bilateral Investment Treaty, Invest Oman and Invest India, and Rupay card acceptance in Oman etc. ]]> https://biospectrumindia.com/news/22/21184/govt-to-cover-covid-19-hospitalisation-and-distress-financing-in-nfhs-6-during-2023-24.html https://biospectrumindia.com/news/22/21184/govt-to-cover-covid-19-hospitalisation-and-distress-financing-in-nfhs-6-during-2023-24.html Thu, 05 May 2022 00:00:00 +0530 Union Minister for Health and Family Welfare, Dr Mansukh Mandaviya has released the National Report of the fifth round of National Family Health Survey (NFHS-5). The report comprises of detailed information on key domains of population, health and family welfare and associated domains like characteristics of the population; fertility; family planning; infant and child mortality; maternal and child health; nutrition and anaemia; morbidity and healthcare; women’s empowerment etc. Key results of NFHS-5 indicate that India has made significant progress in population control measures in recent times. The Total Fertility Rates (TFR), an average number of children per women, has further declined from 2.2 to 2.0 at the national level between NFHS-4 & 5. There are only five States in India, which are above replacement level of fertility of 2.1. They are Bihar (2.98), Meghalaya (2.91), Uttar Pradesh (2.35), Jharkhand (2.26) Manipur (2.17). In NFHS-5, more than three-fourths (77%) children age 12-23 months were fully immunized, compared with 62 percent in NFHS-4. Full vaccination coverage among children ranges from 57 percent in Nagaland to 95 percent in DNH & DD. Odisha (91%), Tamil Nadu (89%), and West Bengal (88%) also have shown relatively higher immunization coverage. NFHS-6, which is scheduled to be conducted during 2023-24, propose to cover various new domain areas, which include COVID-19 hospitalization and distress financing, COVID-19 vaccinations, Utilization of health services –Health and wellness centre, health insurance/ health financing, digital literacy, knowledge of anaemia, Hepatitis B &C, Syphilis etc.” Unlike in previous rounds, NFHS-6 will adopt Urban Frame Survey (UFS, 2012-17) of National Statistical Office (NSO), Ministry of Statistics and Programme Implementation (MoSPI) as a sampling frame for urban area.  ]]> https://biospectrumindia.com/news/22/21166/india-germany-to-focus-on-ai-based-startups-in-healthcare.html https://biospectrumindia.com/news/22/21166/india-germany-to-focus-on-ai-based-startups-in-healthcare.html Tue, 03 May 2022 15:55:00 +0530 India and Germany have agreed to work together with focus on Artificial Intelligence (AI) startups as well as AI research and its application in sustainability and healthcare.   This was stated by Dr Jitendra Singh, Minister for Science & Technology and Earth Sciences after his bilateral talks with German Minister for Education & Research, Bettina Stark-Watzinger.    Both the ministers agreed that there is a lot of scope to work together in Artificial Intelligence for which experts on two sides have already met. An Indo-German call for proposals for this would be raised soon inviting proposals from researchers and industry.   The ministers expressed satisfaction on recently concluded MOU between Department of Science & Technology, Government of India and German Research Foundation (DFG) to support the International Research Training Groups (IRTG) programme would further boost the cooperation towards capacity building targeting the training of Indian and German students for pursuing the PhD programme. The maiden call for inviting proposals under this programme from Indian and German research groups is already on.   Several initiatives for human capacity developments in science and engineering have recently been worked out, which includes Women Involvement in Science and Engineering Research (WISER) to facilitate lateral entry of women researchers into ongoing S&T projects and Paired Early Career Fellowships creating an inclusive ecosystem for the Indo-German S&T cooperation with exchange of young researchers on both sides.  ]]> https://biospectrumindia.com/news/22/21132/nha-rolls-out-nurse-module-of-health-professional-registry-under-abdm.html https://biospectrumindia.com/news/22/21132/nha-rolls-out-nurse-module-of-health-professional-registry-under-abdm.html Wed, 27 Apr 2022 15:15:00 +0530 The National Health Authority (NHA) has rolled out the module for nurses on Health Professional Registry under Ayushman Bharat Digital Mission (ABDM). Nurses providing health services across modern and traditional systems of medicine can also enroll on Healthcare Professional Registry. Applications for enrolment in the registry will be verified by the concerned councils.   Going forward, NHA plans to enroll more categories of health professionals like para-medicals, grass-root level community health workers (ASHAs), medical support staff, allied healthcare professionals etc. in the registry.   Health Professional Registry (HPR) is a comprehensive repository of all healthcare professionals involved in the delivery of healthcare services across both modern and traditional systems of medicine. HPR is a core building block of the Ayushman Bharat Digital Mission (ABDM). Through HPR, healthcare professionals can onboard onto India’s digital health ecosystem and connect patients to healthcare providers or vice versa with last-mile coverage. Benefits of HPR include a unique and trustable identity, online presence and discoverability along with telemedicine and unified digital services.        ]]> https://biospectrumindia.com/news/22/21130/pm-addresses-launch-of-sri-sathya-sai-sanjeevani-hospital-fiji.html https://biospectrumindia.com/news/22/21130/pm-addresses-launch-of-sri-sathya-sai-sanjeevani-hospital-fiji.html Wed, 27 Apr 2022 14:50:00 +0530 Prime Minister Narendra Modi, addressed the opening of Shri Sri Sathya Sai Sanjeevani Hospital in Fiji via a video message. Modi thanked the Prime Minister of Fiji and the people of Fiji for the hospital and said that the hospital is a symbol of the relationship between the two countries, another chapter in the shared journey of India and Fiji.    The Children’s Heart Hospital is one-of-its-kind not only in Fiji but in the entire South Pacific region. He also expressed satisfaction that not only the children will get world-class treatment but all surgeries will be done free of cost and for that he appreciated Sai Prem Foundation, Fiji, Government of Fiji and Shri Sathya Sai Sanjivini Children’s Heart Hospital of India.  ]]> https://biospectrumindia.com/news/22/21125/government-approves-covid-19-vaccines-for-children-aged-5-12-yrs.html https://biospectrumindia.com/news/22/21125/government-approves-covid-19-vaccines-for-children-aged-5-12-yrs.html Tue, 26 Apr 2022 00:00:00 +0530 Drugs Controller General of India (DCGI) has given its nod for emergency use authorisation of Bharat Biotech's BBV152 (COVAXIN) and Biological E (BE)'s CORBEVAX in children 5-12 years of age. Bharat Biotech had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity of COVAXIN in healthy children and adolescents in the 2-18 age group.Fresh stocks of COVAXIN are available and ready for supplies. Bharat Biotech has readily available more than 50 million doses of COVAXIN in vials, and more than 200 million doses as drug substance. Additional production capacity is also available to meet product demand. On the other hand,  BE performed a multi-centric, Phase 2/3 clinical trial in 624 children aged between 5 and 18 in two age sub-sets, i.e., ≥12 to <18 years and ≥5 to <12 years. As a part of the trial, children were administered two doses of 0.5 ml each of the vaccine or placebo in a gap of 28 days. BE has manufactured 30 crore doses of CORBEVAX and have already supplied nearly 10 crore doses to the Government of India.  Currently, over 3 crore doses of CORBEVAX have been administered in children between 12-15 years of age.  ]]> https://biospectrumindia.com/news/22/21113/world-immunization-week-2022-calls-to-accelerate-lifesaving-routine-immunisation-for-children.html https://biospectrumindia.com/news/22/21113/world-immunization-week-2022-calls-to-accelerate-lifesaving-routine-immunisation-for-children.html Mon, 25 Apr 2022 17:25:00 +0530 In observance of the World Immunization Week (WIW) in 2022, UNICEF along with the Ministry of Health and Family Welfare (MoHFW), the Government of India held an interactive engagement session with health journalists to reinforce media support toward increased uptake of Routine Immunization of children. The theme for this year’s immunisation week is ’long life for all,’ with ‘long life’ reflecting the importance of vaccinations for a long and healthy life and the importance of vaccine equity.   As per latest National Family Health Survey (NFHS)-5 data, Full Immunization Coverage (FIC) among children aged 12-23 months has recorded substantial improvement from 62 per cent to 76 per cent at all-India level.   Dr Veena Dhawan, Additional Commissioner (Immunization), MoH&FW, provided an update on the Universal Immunization programme and the Intensified Mission Indradhanush (IMI) 4.0 launched in early 2022 to accelerate the vaccination coverage of children and pregnant women in targeted districts and blocks.   The World Immunization Week also celebrates the extraordinary work of numerous people who have contributed to the creation, development and administering vaccines for the last 300 years. A ‘Love Letter’ thanking the stakeholders will be shared with supporters to write their own thank-you notes for all those who made vaccination possible. A Hero Video which takes the viewer through the epic journey of vaccination across continents and though centuries will be released.   Commending India’s commitment to accelerate immunisation coverage and achieve full immunisation coverage for every child, Dr Vivek Virendra Singh, Health Specialist, Officer In-Charge, Health, UNICEF India, interacted with over 70 national and state media who had joined the discussion online. “The WIW 2022 provides us an opportunity to remind everyone on India’s success in the recent COVID -19 vaccination and earlier Polio eradication, through robust health systems driven immunization campaigns. WIW reiterates the need for Routine Immunization, and the collective action needed to reach every child everywhere with all necessary vaccines,” he said. ]]> https://biospectrumindia.com/news/22/21111/govt-efforts-have-resulted-in-86-45-decline-in-malaria-cases-in-2021-than-2015-dr-mandaviya.html https://biospectrumindia.com/news/22/21111/govt-efforts-have-resulted-in-86-45-decline-in-malaria-cases-in-2021-than-2015-dr-mandaviya.html Mon, 25 Apr 2022 15:25:00 +0530 Union Minister for Health and Family Welfare, Dr Mansukh Mandaviya during his address to commemorate World Malaria Day 2022, said that there is a need to emphasise progressive strengthening of the healthcare delivery system and improve multi-sectoral coordination and collaboration. The theme for this year is 'Harness innovation to reduce the global malaria disease burden and save lives.' Dr Mandaviya called for the prioritisation of malaria elimination through national and sub-national efforts. He emphasised that leveraging technology and innovation will help in developing tailor-made solutions to advance India’s malaria elimination plan and contribute to improved health, quality of life and alleviation of poverty. He added that ground-level frontline healthcare workers including the ASHAs, ANMs along with partner organisations need to work in tandem for creating mass awareness about diagnosis, timely and effective treatment and vector control measures. He further suggested that the private sector including the private practitioners need to align their malaria case management and reporting and related activities with the national programme. The Union Health Minister also detailed the success made in malaria elimination. “India has made remarkable progress in reducing the malaria incidence and deaths. Our efforts have resulted in 86.45 per cent decline in malaria cases and 79.16 per cent reduction in malaria-related deaths in 2021 as compared to 2015. 124 districts in the country have reported ‘zero malaria cases."  Union Minister of State for Health and Family Welfare, Dr Bharti Pravin Pawar highlighted, “Work is going on a mission mode towards eliminating Malaria by 2030. The Union Government is working with the state governments on the ground level to reduce the burden of malaria, including infrastructure improvement and laboratory support.Railway stations at New Delhi, Lucknow, Bhubaneswar and Nagpur will be illuminated in hues of orange and purple to observe World Malaria Day 2022. A manual on Integrated Vector Management 2022 was released on this occasion. The dignitaries took a pledge to adhere to appropriate behaviour and practices to eliminate Malaria by 2030, in time with the achievement of Sustainable Development Goals. States doing exemplary work on malaria elimination were also felicitated. ]]> https://biospectrumindia.com/news/22/21112/pharma-medical-devices-conference-2022-to-draft-plan-for-next-25-years.html https://biospectrumindia.com/news/22/21112/pharma-medical-devices-conference-2022-to-draft-plan-for-next-25-years.html Mon, 25 Apr 2022 00:00:00 +0530 Union Minister for Chemicals & Fertilizers and Health & Family Welfare, Dr Mansukh Mandaviya inaugurated the 7th edition of International conference on Pharma and Medical Devices sector 2022, which is scheduled from 25th to 27th April in the presence of Bhagwanth Khuba, Minister of State for Chemicals and Fertilisers and S Aparna, Secretary, Department of Pharmaceuticals. The annual flagship three-day conference is being held at Dr Ambedkar International Centre, New Delhi. “Conferences like India Pharma and India Medical Device 2022 provide a platform for industry, academia and policy makers to brainstorm and draft a plan for the next 25 years for the sector,” Mandaviya said. At the inaugural ceremony, three knowledge documents- ‘Impact of the pharma industry on the Indian ecosystem in the post- COVID era' by KMPG and FICCI, ‘Enabling Growth and innovation in the Indian Medical Devices Sector’ and a ‘Compilation of important speeches by CEOs’ were also released by the Union Minister. In addition to this, Dr Mansukh Mandaviya chaired two roundtable conferences with the Pharma and Medical Devices CEOs after the inaugural ceremony. In the conference, the Union Minister assured full support of the Government to the Pharma and medical devices sector and sought their feedback and support in preparing a roadmap for the next 25 years. Various issues pertaining to the Pharma and medical devices sector were discussed at the conference. ]]> https://biospectrumindia.com/news/22/21102/niti-aayog-unicef-india-to-develop-report-on-child-development.html https://biospectrumindia.com/news/22/21102/niti-aayog-unicef-india-to-develop-report-on-child-development.html Fri, 22 Apr 2022 16:10:00 +0530 NITI Aayog and UNICEF India have signed a Statement of Intent (SoI) on the Sustainable Development Goals (SDGs) with a focus on children. Reiterating a mutual commitment towards realising the rights of children in India, the SoI seeks to formalise a framework of cooperation to develop and launch the first report on the ‘State of India’s Children: Status and Trends in Multidimensional Child Development.’     UNICEF India and NITI Aayog are developing a comprehensive measure to understand the multidimensional attainments and deprivations among children across health and nutrition, education, water and sanitation, household living standards and protective environment, to analyse the status of children around critical child-related SDGs to establish recent trends. This effort will contribute to the realisation of India’s commitments to the 2030 Agenda and provide a set of policy recommendations for concerted action in terms of accelerating progress towards the SDGs to ‘leave no child behind’ and achieve their holistic development.   The collaboration between NITI Aayog and UNICEF India will draw up the methods, technical analysis, reporting and action planning for the first report on the ‘State of India’s Children’ with a focus on multidimensional aspects of child development like health, nutrition, education, water and sanitation, protection and other relevant areas. This project will undertake a whole-of-society approach involving all stakeholders ranging from Union Ministries, state government, academia, civil society organisations and child rights collectives.         ]]> https://biospectrumindia.com/news/22/21105/gaiis-2022-witnesses-lois-worth-more-than-rs-9000-cr-in-major-ayush-categories.html https://biospectrumindia.com/news/22/21105/gaiis-2022-witnesses-lois-worth-more-than-rs-9000-cr-in-major-ayush-categories.html Fri, 22 Apr 2022 00:00:00 +0530 Creating a  history, India’s first Global Ayush Investment and Innovation Summit (GAIIS) 2022 held in Gandhinagar, Gujarat witnessed letters of intent (LoIs) worth more than Rs 9000 crore  in major categories like FMCG, Medical Value Travel (Heal in India), Pharma, Technology & Diagnostic and Farmers & Agriculture. The assurances of investment include more than Rs. 7000 crore from FMCG, around Rs 1000 crore from Medical Value Travel (MVT), around Rs 345 Crores from Pharma sector, Rs 300 crore for Farmers & Agri category and around Rs 60 crore  in the Technology & Diagnostic category. A total of 12 MoUs were signed between the Central Council for Research in Ayurveda Sciences (CCRAS), Ministry of Ayush and various prestigious research institutes in the country. The institutes include IIT Delhi, IIT Guwahati, ICMR NITM, AIIMS, CSIR, NIPER, NIMHANS, JNU, ICGB, AVP, TDU. One among international MoUs signed was between the Rashtriya Ayurveda Vidyapeeth (RAV), Ministry of Ayush and Fundacion de Salud Ayurveda prema (Ayurveda Prema Health Foundation), Argentina in the field of “the establishment of an academia collaboration in Ayurveda”.  Another, tripartite MoU was signed between All India Institute of Ayurveda (AIIA), Federal University of Rio de Janeiro (UFRJ), Brazil & Brazilian Academic Consortium for Integrative Health (CABSIN), Brazil on the establishment of academic collaboration in Ayurveda. This will promote collaborations on research, advocating safety in the use of Ayurveda in Brazil. An MoU was also signed between All Indian Institute of Ayurveda, Ministry of Ayush and University Health Network, Toronto (UHN), Canada to explore fellowship and graduate student training and mutual collaborations for training of medical doctors and allied health professionals etc. ]]> https://biospectrumindia.com/news/22/21083/pm-lays-foundation-stone-of-who-gctm-in-jamnagar.html https://biospectrumindia.com/news/22/21083/pm-lays-foundation-stone-of-who-gctm-in-jamnagar.html Wed, 20 Apr 2022 10:10:00 +0530 The Prime Minister laid the foundation stone of WHO Global Centre for Traditional Medicine (GCTM) in Jamnagar, in the presence of the Prime Minister of Mauritius Pravind Kumar Jugnauth and Dr Tedros Ghebreyesus, Director-General, World Health Organization (WHO). GCTM will be the first and only global outpost centre for traditional medicine across the world. It will emerge as an international hub of global wellness. Video messages from the Prime Ministers of Bangladesh, Bhutan, Nepal and the President of Maldives were played on the occasion. Union Ministers Dr Mansukh Mandavia, Sabananda Sonowal, Munjapara Mahendrabhai and Chief Minister of Gujarat Bhupendrabhai Patel were among those present.   "The centre will focus on data, innovation and sustainability and will optimise the use of traditional medicine, he added. The centre's five main areas will be research and leadership, evidence and learning, data and analytics, sustainability and equity and innovation and technology," said Dr Ghebreyesus.   The Prime Minister laid down five goals for the centre. First, to create a database of traditional knowledge systems using technology; second, GCTM can create international standards for testing and certification of traditional medicines so that confidence in these medicines improves. Third, GCTM should evolve as a platform where global experts of traditional medicines come together and share experiences. He also asked the centre to explore the possibility of an annual traditional medicine festival. Fourth, GCTM should mobilise funding for research in the field of traditional medicines. Finally, GCTM should develop protocols for the holistic treatment of specific diseases so that patients could benefit from both traditional and modern medicine.     ]]> https://biospectrumindia.com/news/22/21091/pm-nudges-startups-entrepreneurs-industry-to-increase-investment-for-innovation-in-ayush.html https://biospectrumindia.com/news/22/21091/pm-nudges-startups-entrepreneurs-industry-to-increase-investment-for-innovation-in-ayush.html Wed, 20 Apr 2022 00:00:00 +0530 Prime Minister Narendra Modi inaugurated the Global Ayush Investment & Innovation Summit 2022 at Gandhinagar, Gujarat on April 20. The three day Ayush global summit will witness a dialogue with entrepreneurs, industry, startups and other stakeholders to encourage them to increase investment for innovation in Ayush as the sector continues to showcase colossal room for growth. The inaugural session for the Global Ayush Investment & Innovation Summit 2022 witnessed the presence of the Prime Minister of Mauritius, Pravind Kumar Jugnauth, WHO Director General, Dr. Tedros Adhanom Ghebreyesus, Dr. Mansukh Mandaviya, Union Minister of Health & Family Welfare, Union Minister for AYUSH Sarbananda Sonowal, Chief Minister of Gujarat, Bhupendra Patel, Dr. Munjpara Mahendra Kalubhai, Minister of State and ambassadors, foreign dignitaries, investors, industry experts and other important stakeholders. In his inaugural speech Modi said, “We are already witnessing unprecedented growth in the production of Ayush medicines, supplements and cosmetics. In 2014, where the Ayush sector was less than $3 billion, today it has increased to more than $18 billion. An unprecedented efforts has been made in the past years to promote the export of Ayush products.” Many new initiatives in Ayush sector was announced by the Prime Minister, first being a special Ayush mark for Ayush products. This will give people all over the world the confidence of quality Ayush products. Government will develop a network of Ayush parks to encourage the promotion, research and manufacturing of Ayush products across the country.  Further, another major initiative for foreign nationals who want to come to India to take advantage of Ayush therapy was announced. India will soon introduce a special Ayush visa category. ]]> https://biospectrumindia.com/news/22/21060/global-ayush-investment-innovation-summit-to-be-held-from-apr-20-22-in-gandhinagar.html https://biospectrumindia.com/news/22/21060/global-ayush-investment-innovation-summit-to-be-held-from-apr-20-22-in-gandhinagar.html Sat, 16 Apr 2022 00:00:00 +0530 Ministry of Ayush has officially announced their most pertinent event for 2022 – the Global Ayush Investment & Innovation Summit (GAIIS) to be held from 20th – 22nd April 2022 in Gandhinagar. The Global Ayush Investment & Innovation Summit, to be held at Mahatma Mandir in Gandhinagar, Gujarat will be inaugurated by Prime Minister of India, Narendra Modi on 20th April 2022. The three-day summit will witness the participation of industry leaders, academicians, and scholars to deliberate upon ways to promote traditional medicines, and systems. As part of the Summit, 5 Plenary sessions, 8 roundtables, 6 workshops, 2 symposiums, 90 eminent speakers and 100 exhibitors will be present. Speakers and diplomats will be present from across embassies, industries and top corporates. There will also be multiple initiatives to stimulate Ayush exports in international markets. One of the aims of the Summit is to attract lucrative investments to build India as the Global Ayush Destination in the world. In recent years, India has seen enormous investments due to the absence of Foreign Direct Investments (FDI) restrictions. The Ayush Ministry wants to keep building on this and utilize the platform to initiate target-oriented initiatives to enable the recognition and growth of traditional systems of medicine.  The ground-breaking ceremony for the WHO Global Centre for Traditional Medicine will also take place on 19th April, in Jamnagar, Gujarat. This centre will emerge as an international hub of global wellness taking traditional medicine systems of the world to new heights. It will also provide assistance to WHO member countries so that positive health can be spread over the world.     ]]> https://biospectrumindia.com/news/22/21057/govt-keen-to-collaborate-with-tech-providers-to-build-national-digital-health-network.html https://biospectrumindia.com/news/22/21057/govt-keen-to-collaborate-with-tech-providers-to-build-national-digital-health-network.html Thu, 14 Apr 2022 00:00:00 +0530 National Health Authority (NHA), the implementing agency for Ayushman Bharat Digital Mission (ABDM) has extended an open invitation to all interested parties for sharing their Expression of Interest (EoI) for developing innovative solutions that shall help build a national digital health ecosystem for India. This collaborative approach will not just help speed up the development but also will help in making digital public goods available to public and/or private entities. Interested parties shall provide these solutions as a service at no cost to public and/or private entities. Sharing the thought behind the NHA’s invitation for Expression of Interest (EoI), Dr R.S. Sharma, CEO, NHA added “The National Health Authority is giving an open call inviting all interested parties to contribute to the Unified Health Interface (UHI), Health Claims Protocol (HCP), and various other open-source digital public goods being created to expand the digital health ecosystem.”  The interested developers/ parties can also make a significant contribution to the national digital health ecosystem development by sharing their Expression of Interest (EoI). Some illustrative examples of the contribution for this cause are Unified Health Interface (UHI), Health Claims Platform (HCP), Software as a Service (SaaS), Open-Source Solutions and others. ]]> https://biospectrumindia.com/news/22/21036/union-health-minister-odisha-cm-inaugurate-medical-college-in-puri.html https://biospectrumindia.com/news/22/21036/union-health-minister-odisha-cm-inaugurate-medical-college-in-puri.html Tue, 12 Apr 2022 07:00:00 +0530 Dr Mansukh Mandaviya, Union Minister of Health & Family Welfare and Naveen Patnaik, Chief Minister of Orissa jointly dedicated the Shri Jagannath Medical College & Hospital (SJMCH) in Puri, Odisha to the nation. Manohar Agnani, AS, Health Ministry, Hekali Zhimomi, JS, Health Ministry and other senior officials of the Ministry were also present on the occasion.    Expressing his elation at the event, Dr Mandaviya said that the hospital will play a pivotal role in training doctors and providing good medical facilities to the people of Odisha. He interacted with the students who will be part of the inaugural batch of the hospital and motivated them to work hard and serve in the remotest corners of the country so that healthcare can reach the last mile.   The Union Health Minister requested the Chief Minister to integrate Ayushman Bharat Yojana with the existing state health facilities to further improve the access to healthcare in India. Patnaik congratulated the students and informed them that 15 per cent of seats in the hospital are reserved for students from government schools.    The SJMCH is part of five medical colleges built under Phase I of the scheme for ‘Establishment of new medical colleges attached with existing district/referral hospitals’. All the hospitals under the scheme have been built at an approved cost of Rs 945 Cr with 60 per cent of the contribution (Rs 567 crore) coming from the Union Government. With the inauguration of the SJMCH, all five medical colleges have become functional now. ]]> https://biospectrumindia.com/news/22/21027/india-calls-upon-countries-of-shanghai-cooperation-organisation-for-scientific-innovations-.html https://biospectrumindia.com/news/22/21027/india-calls-upon-countries-of-shanghai-cooperation-organisation-for-scientific-innovations-.html Fri, 08 Apr 2022 00:00:00 +0530 Union Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr Jitendra Singh called upon the countries of Shanghai Cooperation Organisation (SCO) to join hands to innovate affordable scientific solutions for common challenges like ensuring food, affordable healthcare and energy access for its people. Addressing the SCO meeting through virtual mode, Dr Jitendra Singh said, the member countries must jointly address emerging challenges of environmental problems like climate change and biodiversity loss.  Dr Jitendra Singh pointed out that as a result of consistent boost to research and innovation, India has reached 3rd position in scientific publication as per National Science Foundation (NSF) database. The country has featured within the top 50 innovative economies globally (at 46th rank), as per Global Innovation Index (GII) and it has also reached 3rd Position in term of no. of PhDs, in size of Higher Education System; as well as in terms of no. of startups, the Minister added. ]]> https://biospectrumindia.com/news/22/20983/nha-invites-feedback-on-consultation-paper-on-drug-registry.html https://biospectrumindia.com/news/22/20983/nha-invites-feedback-on-consultation-paper-on-drug-registry.html Thu, 31 Mar 2022 15:30:00 +0530 The National Health Authority (NHA) has released a consultation paper on Drug Registry. Envisioned under the ambitious Ayushman Bharat Digital Mission (ABDM), drug registry is intended to be a single, up-to-date, centralised repository of all the drugs across all systems of medicine that are approved and are available in the Indian market. The drug registry application is proposed to be designed using open-source technologies and will be interoperable.    The consultation paper focuses only on drug registry within the National Digital Health Ecosystem and offers NHA’s current vision on the functionalities of the proposed drug registry, the process for its creation and potential benefits to various ecosystem stakeholders. Each section has specific open questions where feedback from stakeholders is sought. Comments from the public are invited to ensure that Drug Registry is designed and developed in a collaborative and consultative manner.    Dr RS Sharma, CEO, National Health Authority, remarked, “I urge all stakeholders to go through the shared consultation papers and provide us with their valuable feedback.”   NHA will organise a public webinar on drug registry to explain the consultation paper on April 19, 2022, from 3 pm onwards.    ]]> https://biospectrumindia.com/news/22/20944/himachal-pradesh-govt-signs-mou-with-niper-as-knowledge-partner-for-medical-devices-park.html https://biospectrumindia.com/news/22/20944/himachal-pradesh-govt-signs-mou-with-niper-as-knowledge-partner-for-medical-devices-park.html Fri, 25 Mar 2022 00:00:00 +0530 Chief Minister Jai Ram Thakur has announced that the Himachal Pradesh Government has signed a Memorandum of Understanding (MoU) with National Institute of Pharmaceutical Education and Research (NIPER), Mohali as Knowledge Partner for upcoming Medical Devices Park, Nalagarh in District Solan. This MoU was approved by the Board of Members from the Department of Pharmaceuticals, Government of India. Thakur said that HPSIDC is the State Implementing Agency for conception, development and execution of Medical Devices Park. NIPER Mohali will establish a Centre for Excellence in the Medical Devices Park that will enable Industry-Academia linkage. He said that such linkage is becoming vital for sustainability of industry in present times as technology obsolescence is rapid. He also said that for any manufacturer constant evolution and innovation becomes imperative to stay ahead in the learning curve and compete globally. State Planning Department has sanctioned Rs 74.95 crore to the State Implementing Agency for development of this park and the Department of Pharmaceuticals, GoI would soon release first installment worth Rs 30 crore of grant-in aid.   ]]> https://biospectrumindia.com/news/22/20935/govt-unveils-data-driven-research-to-eradicate-tb-dare2erad-tb.html https://biospectrumindia.com/news/22/20935/govt-unveils-data-driven-research-to-eradicate-tb-dare2erad-tb.html Thu, 24 Mar 2022 16:50:00 +0530 Union Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr Jitendra Singh has announced the launch of Data-Driven Research to Eradicate TB- Dare2eraD TB by the Department of Biotechnology (DBT), M/o Science & Technology, on the occasion of World TB Day, on March 24th.    Addressing the event to inaugurate 'Step Up to End TB' event at Vigyan Bhawan, New Delhi by Anandiben Patel, Governor of Uttar Pradesh in presence of Dr Mansukh Mandaviya, Union Minister of Health & Family Welfare and Dr Bharati Pravin Pawar, Minister of State of Ministry of Health& Family Welfare, Dr Singh said that there is a need for a mass movement to get rid of tuberculosis.   The minister said that Dare2eraD TB will be the umbrella TB programme of DBT comprising of the following key initiatives-    InTGS - Indian Tuberculosis Genomic Surveillance Consortium;  InTBK Hub- Indian TB Knowledge Hub- Webinar Series;  Host Directed therapies against TB and develop an evidence-based regimen for treating extra-pulmonary tuberculosis.   Dr Singh said that the Indian Tuberculosis Genomic Surveillance Consortium (InTGS) is proposed on lines of the Indian SARS-CoV-2 Genomic Consortia (INSACOG). The InTBK Hub- Indian TB Knowledge Hub will be a webinar series that will create academia-industry connections to discuss challenges and exchange ideas and carry forward open innovations between all TB stakeholders.    ]]> https://biospectrumindia.com/news/22/20927/novavax-covid-19-vaccine-receives-dcgi-approval-for-adolescent-population.html https://biospectrumindia.com/news/22/20927/novavax-covid-19-vaccine-receives-dcgi-approval-for-adolescent-population.html Wed, 23 Mar 2022 00:00:00 +0530 US-based Novavax, Inc. and Serum Institute of India (SII) have announced that the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax' protein-based COVID-19 vaccine for adolescents aged ≥12 to <18 years in India. The vaccine, also known as NVX-CoV2373, is manufactured and marketed in India by SII under the brand name Covovax and is the first protein-based vaccine authorized for use in this age group in India. Covovax is the fourth vaccine to receive EUA from the DCGI for use among adolescents 12 and older. The safety and efficacy of Covovax in adolescents aged less than 12 years have not yet been established; however, studies evaluating the safety and immunogenicity of Covovax for the age groups of ≥7 to <12 and ≥2 to <7 years in India are underway. A Phase 2/3, observer-blinded, randomized, controlled study in a total of 460 Indian adolescents aged ≥12 to <18 years was conducted to evaluate the safety and immunogenicity of Covovax. The study demonstrated that Covovax was well-tolerated with a reassuring safety profile. ]]> https://biospectrumindia.com/news/22/20877/govt-releases-national-medical-devices-policy-2022-draft-for-consultation.html https://biospectrumindia.com/news/22/20877/govt-releases-national-medical-devices-policy-2022-draft-for-consultation.html Sun, 13 Mar 2022 00:00:00 +0530 The Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers has released on its website, an Approach Paper for the Draft National Policy for the Medical Devices, 2022, inviting feedback and remarks of the Industry and stakeholders, till the 25th of March 2022.  This policy, while addressing the core objectives of accessibility, affordability, safety and quality, focuses on self-sustainability and innovation. The salient features include regulatory streamlining; quality standards and safety of the devices; building competitiveness through fiscal and financial support; infrastructure development; facilitating R&D and innovation; human resource development; and awareness creation and brand positioning. This policy envisions that by 2047, India will be having few National Institutes of Medical Devices Education and Research (NIMERs) on the lines of NIPERs; will be home & originator to 25 high-end futuristic technologies in medtech; and will have a medtech industry of $100-300 billion size with 10-12% of global market share.   ]]> https://biospectrumindia.com/news/22/20873/govt-approves-india-us-mou-on-infectious-diseases-including-tb-hiv.html https://biospectrumindia.com/news/22/20873/govt-approves-india-us-mou-on-infectious-diseases-including-tb-hiv.html Thu, 10 Mar 2022 00:00:00 +0530 The Union Cabinet, chaired by Prime Minister Narendra Modi, was apprised of a Memorandum of Understanding (MoU) signed between the Indian Council of Medical Research (ICMR) and the National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health of Department of Health and Human Services, USA, in September 2021 Cooperation shall be undertaken primarily in Chennai, India at the National Institute for Research on Tuberculosis (NIRT) of ICMR in the scientific area, including but not limited to, basic, translational and applied innovative research, epidemiology, medicine, molecular biology, medical entomology, parasitology, immunology, medicine, microbiology and virology, with a focus on techniques for prevention, diagnosis and treatment of tropical infectious and allergic diseases. Focus on collaboration includes tuberculosis, parasitic infections, HIV/AIDS, Allergic diseases, immune system diseases, other emerging and re-emerging pathogens, and other diseases of shared scientific interest. The Parties may seek additional funding and active participation from governmental, non-governmental, private sector, foundation, and other sources, as necessary and consistent with usual and customary practice, to support individual projects. ]]> https://biospectrumindia.com/news/22/20862/cabinet-approves-mou-between-icmr-oxford-university.html https://biospectrumindia.com/news/22/20862/cabinet-approves-mou-between-icmr-oxford-university.html Wed, 09 Mar 2022 13:40:00 +0530 The Union Cabinet, chaired by Prime Minister Narendra Modi, was apprised of a Memorandum of Understanding (MoU) signed between the Indian Council of Medical Research (ICMR) and the Oxford University, the UK in November 2021 and following Rule 7(d)(i) of the Second Schedule of the Government of India (Transaction of Business) rules 1961.   The objectives under the MoU are capacity building for Indian scientists and researchers, collection of data compliant with international standards and regulatory requirements, development of India towards becoming a regional hub for capacity development using its funds and following the principles of equity and sovereignty, jointly raise and pool funds with time-bound hosting of Infectious Diseases Data Observatory (IDDO) secretariat towards achieving the outcomes at ICMR, and building partnership in and beyond data and skill-sharing with equity and transparency.   Both the parties have agreed to exchange and share ideas on three vector-borne diseases in the elimination phase (malaria, visceral leishmaniasis, filariasis) and emerging infections, Support and develop best practices for data management, data documentation, data sharing and the development of equitable governance frameworks, explore opportunities for collaboration on research programmes and to develop a three-year work plan on capacity strengthening, exchange of research fellows, training on data management and statistical analysis.   The parties shall each bear their costs concerning the collaboration envisaged by this MoU. If the Parties subsequently secure funding for an element of the activities envisaged by this MoU, and part of that funding is intended to be passed to the other party, an additional agreement will be executed to govern the activity in question. ]]> https://biospectrumindia.com/news/22/20856/high-utilisation-of-ab-pm-jay-services-among-women-study.html https://biospectrumindia.com/news/22/20856/high-utilisation-of-ab-pm-jay-services-among-women-study.html Tue, 08 Mar 2022 18:35:00 +0530 A recent study on ‘Gender’ under AB PM-JAY from October 2019 to September 2021 reveals that female utilisation of AB PM-JAY services stood at 46.7 per cent of the total utilisation. States like Karnataka, Andhra Pradesh, Chhattisgarh, Mizoram, Meghalaya and Sikkim observe higher female utilisation under AB PM-JAY than males for the stipulated period. AB PM-JAY currently provides as many as 59 packages and 77 procedures under the speciality of obstetrics and gynaecology for women, enabling increased access to better healthcare services and thus helping in the reduction of maternal and child mortality. In the same, it has been observed that obstetrics and gynaecology utilisation under the scheme is the second most utilised speciality after general medicine in over 15 states.    Besides the above-mentioned procedures, other specialisations like oncology (58 per cent) and ophthalmology (51 per cent) have also seen a higher female beneficiary utilisation than males under AB PM-JAY.   "The Ayushman Bharat PM-JAY scheme is setting a great example for promoting gender equity and equal opportunities in access to health benefits and medical assistance for all. The high representation of female beneficiaries in the scheme is a testament to our commitment to this endeavour. I hope we can continue this tradition and keep this inclusiveness alive,” said Dr RS Sharma, CEO, National Health Authority while releasing the study.   ]]> https://biospectrumindia.com/news/22/20854/indias-first-women-owned-flo-industrial-park-begins-operations-in-hyderabad.html https://biospectrumindia.com/news/22/20854/indias-first-women-owned-flo-industrial-park-begins-operations-in-hyderabad.html Tue, 08 Mar 2022 18:25:00 +0530 India’s first women-owned FLO Industrial Park promoted by FICCI Ladies Organization (FLO) in partnership with the Govt of Telangana, has commenced its operations in Hyderabad. 25 women-owned and operated units representing 16 diverse Green Category Industries are part of the team.   The 50-acre FLO Industrial Park in Hyderabad was established with an investment of Rs 250 crores is the flagship project and the first-of-its-kind at a national level with participation open to Chapter Members, and the national members of FLO.    The 50-acre Industrial Park exclusively for women was formally inaugurated by KT Rama Rao, Minister for IT E&C, MA&UD, and Industries & Commerce Departments in the presence of Jayesh Ranjan, Principal Secretary IT, Govt of Telangana, and others.   From the Electronic sector to packaging, Medical Devices, Wellness, Engineering, and Food Processing, the park is at its core to demonstrate the power of women in the industry. ]]> https://biospectrumindia.com/news/22/20840/dst-selects-iit-madras-for-gati-initiative-.html https://biospectrumindia.com/news/22/20840/dst-selects-iit-madras-for-gati-initiative-.html Mon, 07 Mar 2022 17:30:00 +0530 Indian Institute of Technology Madras has been selected by the Department of Science and Technology, Government of India, to advance women in STEM (Science, Technology Engineering, and Mathematics).  Called GATI or ‘Gender Advancement for Transforming Institutions initiative,’ it seeks to develop and implement policies and address issues in a systematic and timely manner.   IIT Madras is keen to contribute to DST’s vision to develop the country’s first National Assessment and Accreditation Model for S&T institutions, which is based on gender-sensitive practices. The Institute is proud to be selected as one of the 30 pilot institutions that will implement this quantitative methodology, to surface the specific gender-based issues.    The DST partnered with British Educational Institutions to develop GATI, which aims to bring about tangible and positive changes in terms of the improvement of gender ratios. A Gender Equity Charter has also been developed for an India-specific context. Dr Pratibha Jolly, former Principal, Miranda House, Delhi, and her team have developed a methodology for evaluation and assessment of the institutional gender climate, with a uniquely Indian look.    The plans for the immediate future include: Seminar series – storytelling from women leaders from various spheres Upskilling activities – career advancement and networking workshops for staff Support for women research scholars – to enhance mobility and opportunitie Community outreach activities – to spread the love of STEM in young women  Collaborations – programmes for women faculty for international mobility ]]> https://biospectrumindia.com/news/22/20816/government-announces-major-healthcare-boost-for-mizoram.html https://biospectrumindia.com/news/22/20816/government-announces-major-healthcare-boost-for-mizoram.html Thu, 03 Mar 2022 00:00:00 +0530 The Union Minister of Ayush and Ports Shipping & Waterways Sarbananda Sonowal has announced a slew of measures to boost the AYUSH sector in Mizoram. The Minister, along with the Chief Minister of Mizoram, Zoramthanga, laid the foundation stones for six Ayush hospitals in Mizoram. In a further boost to healthcare infrastructure in the hill state of the Northeast, as many as 24 Ayush Health & Wellness Centres (HWC) were inaugurated across Mizoram.  The three 50 bedded hospitals will be developed at Aizawl, Champai and Hnahthial in the state. The three 10 bedded hospitals will be developed at Khawzawl, Saitul and Hortoki in the state. The Union Minister  while highlighting the importance of traditional Indian medicine spoke about the role the folk medicine of Northeast can play in palliative, preventive, curative patient care along with the modern healthcare. ]]> https://biospectrumindia.com/news/22/20774/cabinet-approves-implementation-of-abdm-with-budget-of-rs-1600-cr-for-five-years.html https://biospectrumindia.com/news/22/20774/cabinet-approves-implementation-of-abdm-with-budget-of-rs-1600-cr-for-five-years.html Sat, 26 Feb 2022 00:00:00 +0530 The Union Cabinet, chaired by Prime Minister Narendra Modi has approved the national roll-out of Central Sector Scheme, Ayushman Bharat Digital Mission (ABDM) of Ministry of Health and Family Welfare, Government of India, with a budget of Rs 1,600 crore for five years. The National Health Authority (NHA) will be the implementing agency of Ayushman Bharat Digital Mission (ABDM). Under the ABDM, citizens will be able to create their ABHA (Ayushman Bharat Health Account) numbers, to which their digital health records can be linked. This will enable creation of longitudinal health records for individuals across various healthcare providers, and improve clinical decision making by healthcare providers. The mission will improve equitable access to quality healthcare by encouraging use of technologies such as telemedicine and enabling national portability of health services. The pilot of ABDM was completed in the six Union Territories of Ladakh, Chandigarh, Dadra & Nagar Haveli and Daman & Diu, Puducherry, Andaman and Nicobar Islands and Lakshadweep with successful demonstration of technology platform developed by the NHA. During the pilot, digital sandbox was created in which more than 774 partner solutions are undergoing integration. As on 24th February 2022, 17,33,69,087 Ayushman Bharat Health Accounts have been created and 10,114 doctors and 17,319 health facilities have been registered in ABDM. ]]> https://biospectrumindia.com/news/22/20764/phdcci-organises-session-on-schemes-offered-by-ministry-of-ayush-.html https://biospectrumindia.com/news/22/20764/phdcci-organises-session-on-schemes-offered-by-ministry-of-ayush-.html Fri, 25 Feb 2022 13:05:00 +0530 PHD Chamber organised a technical session on Incentive and Schemes offered by Ministry of AYUSH, Government of India for ASU Sector during AYUSH e-Mela. The AYUSH E-Mela technical session was attended by more than 250 delegates from industry and academia and exhibitors participating in the expo.   Speakers present were Vikram Singh, Director, Ministry of AYUSH, Govt. of India, Jitender Sodhi, Co-Chair, AYUSH Committee, PHD Chamber and CMD, AYUSH Herbs, Dr Santosh Joshi, Co-Chair, AYUSH Committee & Sr. General Manager, (R&D) Hamdard Laboratories India, Dr Anup Kalra, Director, QCS Herbals, Amit Patwal, Assistant Secretary, PHDCCI and the session is moderated by Dr Ravi Rathod, Joint Secretary, PHDCCI.   Singh gave an insight on various schemes offered by the Ministry and also shared their objectives. He further highlighted a few significant schemes on Ayurgyan Scheme and brief about the Champion Services Sector Scheme which is another scheme offered by the ministry. He highlighted that Ministry of AYUSH is also working closely with BIS to develop service standards for medical value travel and also collaborated with the Ministry of Tourism and created a National Medical wellness and Tourism Board.   Kalra shared a brief presentation and talk about strengths and rich tradition and the use of quality herbs for improving the health and immunity of any individual. He also mentioned today’s global requirements and major requirements of the AYUSH Industry. He also showcased a way forward to work together and value chain development strategies required in medicinal plants cultivation.   Dr Joshi proposed a formal vote of thanks to all the dignitaries.    ]]> https://biospectrumindia.com/news/22/20741/health-ministry-unveils-icmr-dhr-policy-on-biomedical-innovation.html https://biospectrumindia.com/news/22/20741/health-ministry-unveils-icmr-dhr-policy-on-biomedical-innovation.html Thu, 24 Feb 2022 16:45:00 +0530 Dr Mansukh Mandaviya, Union Minister of Health and Family Welfare along with Dr Bharti Pravin Pawar, Minister of State for Health and Family Welfare has launched the ICMR/ DHR Policy on Biomedical Innovation & Entrepreneurship for Medical Professionals, Scientists and Technologists at Medical, Dental, Para-Medical Institutes/Colleges.    As per the policy, medical professionals/ doctors will be encouraged to pursue entrepreneurial ventures by forming startup companies, taking an adjunct position in the company - non-executive director or scientific advisor.   The doctors will also be permitted to undertake inter-institutional and industry projects alone or through companies, license technologies to business entities leading to commercialisation, revenue generation for self-sustenance and societal benefit.   The medical professionals will also be permitted to take up sabbatical for translational and commercialisation of their innovation through their start-up company set-up following the institute’s permission.    The policy will promote interdisciplinary collaboration, innovation, technology development, skill development and foster entrepreneurship development and Make-in-India product development for societal benefit. DHR- ICMR formulated this policy in consultation with other government departments/ ministries/organisations such as DPIIT, DST, WIPO, DSIR, AIIMS, IIT Delhi etc.      ]]> https://biospectrumindia.com/news/22/20729/union-health-min-releases-institute-for-competitiveness-reports-on-covid-vaccination.html https://biospectrumindia.com/news/22/20729/union-health-min-releases-institute-for-competitiveness-reports-on-covid-vaccination.html Thu, 24 Feb 2022 07:55:00 +0530 Union Minister of Health and Family Welfare Dr Mansukh Mandaviya released two reports of the Institute for Competitiveness (part of the global network of the Institute for Strategy and Competitiveness and affiliated to Harvard Business School), in Delhi. The reports titled ‘COVID-19-India’s Vaccine Development Story’ and ‘India's COVID – 19 Vaccination Administration Journey’ highlight the crucial aspects that have contributed to the success of India's COVID-19 vaccine development and administration efforts, which includes manufacturing of indigenous vaccines, sturdy and timely procedures and protocols for approvals that ensured the safe administration of vaccinations.    The reports acknowledge the significant challenges faced by the Indian government, of delivering and administering vaccines to a majority of 1.3 billion people of India who were eligible for the COVID-19 vaccines; working with the state governments to ensure free and equitable distribution and effective management of vaccine eagerness along with addressing vaccine hesitancy that was prevalent in certain pockets of the country.    The reports also identify efforts towards training and skilling of healthcare professionals to manage adverse events during vaccination; digital scheduling of vaccination sessions and certification post-vaccination through the CoWin digital platform as global best practices that other countries can learn from India. The measures taken to ensure social distancing and efforts of all stakeholders and partners have been recognised. The documents also study the quality of vaccination sessions; cold-chain infrastructure and logistics performance, and real-time monitoring and feedback through control rooms that were set at national and sub-national levels all for smooth management of the vaccination process. ]]> https://biospectrumindia.com/news/22/20709/biological-es-covid-19-vaccine-receives-eua-for-12-18-yrs-old.html https://biospectrumindia.com/news/22/20709/biological-es-covid-19-vaccine-receives-eua-for-12-18-yrs-old.html Tue, 22 Feb 2022 00:00:00 +0530 Hyderabad-based Biological E (BE) has announced that its CORBEVAX vaccine, which is India's first indigenously developed Receptor Binding Domain (RBD) Protein sub-unit vaccine against COVID-19, has received emergency use authorisation (EUA) from India's drug regulator for the 12 to 18-year age group. The Drugs Controller General of India (DCGI) has already approved CORBEVAX for restricted use in emergency situation among adults on December 28, 2021. BE received the approval for restricted use in an emergency situation in adolescents aged 12 to less than 18 years based on interim results (of the ongoing phase II/III clinical study). Last September, BE received approval to conduct a Phase II/III clinical trial on CORBEVAX in children and adolescents aged 5 to 18 years. Based on the no-objection certificate, BE initiated the clinical study in October 2021 and evaluated the available safety and immunogenicity results of the ongoing phase II/III study, which indicated that the vaccine is safe and immunogenic. The CORBEVAX vaccine is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees’ Celsius temperature and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial and 10 mL (20 doses) vial pack BE conducted phase I/II, II/III clinical trials of its CORBEVAX vaccine for adults in the country. In addition, it conducted a Phase III active comparison clinical trial to evaluate superiority over Covishield vaccine. ]]> https://biospectrumindia.com/news/22/20694/chief-minister-bhupendra-patel-announces-new-biotechnology-policy-of-gujarat.html https://biospectrumindia.com/news/22/20694/chief-minister-bhupendra-patel-announces-new-biotechnology-policy-of-gujarat.html Fri, 18 Feb 2022 00:00:00 +0530 Chief Minister Bhupendra Patel has unveiled the new ‘Gujarat Biotechnology Policy 2022-27’ with a commitment to promote rapid and inclusive growth in the biotechnology industry in Gujarat. Jitu Vaghani, State Minister of Education, Science & Technology, accompanied the Chief Minister during the launch of new policy at Science City, Ahmedabad. Bhupendra Patel said that, “being a policy driven and business-friendly state, Gujarat has remained at the industry forefront in the country. New forms of entrepreneurship have emerged with the adoption of science and technology in the state.” “Biotechnology has made significant contributions in solving new-age problems, especially in the field of health and agriculture. The science-driven industry has been instrumental in understanding and fighting the global COVID19 pandemic. It was due to biotechnology that we got effective rapid antigen tests, RT-PCR tests, vaccines, etc,” the CM added. According to the new policy, MSMEs with a capital investment of less than Rs 200 crore will be given maximum assistance of Rs 40 crore and mega/large projects with a capital investment of more than Rs 200 crore as well as special projects like ecosystem empowerment, emerging technologies in challenging areas and of strategic importance will be given assistance of up to 25% of the total capital expenditure up to a maximum of Rs 200 crore. This assistance will be provided in the form of 20 quarterly instalments over a period of 5 years. The new policy will further strengthen the ecosystem by providing support to the special projects such as pre-clinical testing, genome sequencing in private sector, plug and play facilities, private sector BSL-3 lab-vaccine development, and manufacturing, testing and certification laboratories. Gujarat’s Biotechnology sector has more than 200 biotechnology companies and a thriving startup ecosystem. In order to provide further support to the sector, Government of Gujarat has announced plans to establish a Bulk Drug Industrial Park in Jambusar Taluka of Bharuch District and a Medical Device Industrial Park at Viramgam/ Rajkot. ]]> https://biospectrumindia.com/news/22/20597/niti-aayog-usaid-to-accelerate-health-innovation-and-entrepreneurship-in-india.html https://biospectrumindia.com/news/22/20597/niti-aayog-usaid-to-accelerate-health-innovation-and-entrepreneurship-in-india.html Tue, 08 Feb 2022 19:15:00 +0530 Atal Innovation Mission (AIM), NITI Aayog, and the US Agency for International Development (USAID) have announced a new partnership under the Sustainable Access to Markets and Resources for Innovative Delivery of Healthcare (SAMRIDH) initiative.   The partnership will improve access to affordable and quality healthcare for vulnerable populations in tier-II and tier-III cities, and rural and tribal regions.    It will enhance SAMRIDH’s efforts to reach vulnerable populations, leveraging AIM’s expertise in innovation and entrepreneurship. AIM and SAMRIDH will leverage philanthropic capital, and public sector resources to offset barriers for commercial investments in small and medium health enterprises to invest in and scale healthcare solutions.   The collaboration will focus on innovations across the healthcare landscape with the common goal to mount an effective response to the ongoing third wave of COVID-19 and build health system preparedness for future infectious disease outbreaks and health emergencies. ]]> https://biospectrumindia.com/news/22/20580/dcgi-gives-authorisation-to-russias-sputnik-light-vaccine-for-covid-19.html https://biospectrumindia.com/news/22/20580/dcgi-gives-authorisation-to-russias-sputnik-light-vaccine-for-covid-19.html Mon, 07 Feb 2022 00:00:00 +0530 The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) has announced that the Russian one-shot Sputnik Light vaccine against coronavirus has been authorized by the Drug Controller General of India (DCGI). Sputnik Light has been registered in more than 30 countries with total population of over 2.5 billion people. A number of countries, including Argentina, Bahrain, UAE, San Marino and Philippines, have already authorized Sputnik Light as a universal booster. A preliminary study of the Gamaleya Center has found that Sputnik Light as a booster significantly increases virus-neutralizing activity against Omicron, which is comparable to titers observed after Sputnik V against wild-type virus, associated with high levels of protection. Dr. Reddy’s Laboratories, a major partner of RDIF in India, has conducted local clinical trials of Sputnik Light in India. Positive data from these trials have been presented to India's regulator and contributed to the positive decision by DCGI. Clinical studies and the real-world data in many countries have demonstrated Sputnik Light is a safe and effective vaccine when used both on a standalone basis and as a booster. Sputnik Light will add to India’s national vaccine portfolio and join Sputnik V, which was approved in the country in April 2021. India is the leading production hub for Sputnik V. ]]> https://biospectrumindia.com/news/22/20500/experts-discuss-regulatory-reforms-ease-of-doing-biz-at-health-wellness-week.html https://biospectrumindia.com/news/22/20500/experts-discuss-regulatory-reforms-ease-of-doing-biz-at-health-wellness-week.html Sun, 30 Jan 2022 08:40:00 +0530 The India Pavilion at EXPO2020 Dubai hosted a roundtable, ‘India – Pharmacy of the world’ as part of the ongoing Health & Wellness week, wherein many governments and industry experts discussed the key focus areas including regulatory reforms, pharma exports, ease of doing business, R&D financing mechanisms and clinical trial scenario in India.   In his virtual address, N Yuvraj, Joint Secretary (Policy, Medical Device, Pharma Bureau), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India (GoI) said, “The current valuation of the Indian pharma industry is $41 billion, which has the potential to grow up to $130 billion by 2030. There is a strong potential for further growth for the industry, but it should be in a holistic manner from across the value chain.”   Dr Rubina Bose, Deputy Drugs Controller (India), Central Drugs Standard Control Organization said, “We have taken various measures to streamline the drug regulatory system in the country by ensuring transparency, accountability and promote innovations, scientific and ethical research. These measures are aligned with the National Health Policy, which aims to improve and strengthen the regulatory environment for easing drugs and devices manufacturing while promoting Make in India.”    Uday Bhaskar, Director General, Pharmexcil, Ministry of Commerce, GoI said, “India is doing extremely well in the pharma export. The Indian pharmaceutical industry is continuing the legacy of providing the medicines at a very affordable price not only to the underdeveloped countries and the developing countries but also to the well-developed and highly regulated markets.”   The roundtable was also attended by Taher Karampurwala, Cluster Head – APAC and MENA, Cipla along with other dignitaries, who joined the session virtually including Dr Dulal Panda, Director, NIPER Mohali, Dr Manish Diwan, Head – Strategy Partnership & Entrepreneurship Development, BIRAC, Department of Biotechnology, GoI, Vikrant Shrotriya, MD, Novo Nordisk India, Dr Murali Ramachandra, CEO, Aurigene Discovery Technologies (Subsidiary of Dr Reddy’s Laboratories) and Ms Suneela Thatte, Vice President and Head- R&D India, Merck KGaA. Indian pharma manufacturers export nearly half of the pharma production, both in terms of volume and value to the US, UK, South Africa, Russia and other countries.    The Health & Wellness week at India Pavilion will conclude on 4th February 2022. ]]> https://biospectrumindia.com/news/22/20474/dcgi-gives-nod-to-market-authorisation-of-covaxin-and-covishield-vaccines.html https://biospectrumindia.com/news/22/20474/dcgi-gives-nod-to-market-authorisation-of-covaxin-and-covishield-vaccines.html Thu, 27 Jan 2022 00:00:00 +0530 The Director Controller General of India (DCGI) has given nod to market authorisation of two COVID19 vaccines- Covaxin and Covishield, subject to certain conditions. The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) had recommended for upgradation of status for the vaccines from restricted use in emergency situations to grant of new drug permission with conditions in the adult population on 19th January 2022. The market authorisation of two COVID-19 vaccines, Covaxin and Covishield, in the country by DCGI is subject to the conditions that firms shall submit data of overseas ongoing clinical trials of the product with due analysis on six monthly basis or as and when available, whichever is earlier. The vaccine shall be supplied for programmatic setting and all vaccinations done within the country to be recorded on CoWIN platform and Adverse Event Following Immunization (AEFI), Adverse Event of Special Interest (AESI) shall continue to be monitored. The firms shall submit the safety data including AEFI and AESI with due analysis on six monthly basis or as and when available, whichever is earlier as per NDCT Rules, 2019. “Conditional Market Authorisation” is a new category of market authorisation that has emerged during the current global pandemic of COVID-19. The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines. ]]> https://biospectrumindia.com/news/22/20367/pm-declares-16-jan-as-national-startup-day-to-take-startup-culture-ahead.html https://biospectrumindia.com/news/22/20367/pm-declares-16-jan-as-national-startup-day-to-take-startup-culture-ahead.html Mon, 17 Jan 2022 09:20:00 +0530 The Prime Minister Narendra Modi has announced that January 16 will be celebrated as National Startup Day, to take the Startup culture to the far flung areas of the country. This announcement was made during the National Startup Awards 2021 ceremony which was recently held where 46 startups were felicitated. During the ceremony, the results of the National Startup Awards (NSA) 2021 were declared. The award was presented by Piyush Goyal, Union Minister of Commerce & Industry, Consumer Affairs, Food & Public Distribution and Textiles. In Health and Wellness segment, Health Arx Technologies bagged recognition for diabetes management; Sascan Meditech for OralScan, the the first multimodal image capturing device that uses multispectral imaging technology at its core for non-invasive and real-time screening of oral cancer and biopsy guidance. Bionic Hope has received the award for Grippy, a lightweight and affordable battery-powered prosthesis available in the Indian market for people below elbow amputation age 15 years and above.Leucine Rich Bio received the award to develop and commercialise South Asia's first gut microbiome test called Bugspeaks. BugSpeaks platform has been able to analyse gut microbial sequencing data comprehensively to provide actionable and personalised dietary and supplementation recommendations.Atreya Innovations' Nadi Tarangini report combines Indian holistic science, western medical science and AI to provide personalised and predictive health and wellness insights. The startup is currently functioning in 12 countries with over 480 doctors and has tested over one lakh patients.The second edition of the awards invited applications across 15 sectors and 49 sub-sectors. The sectors included agriculture, animal husbandry, drinking water, education and skill development, energy, enterprise technology, environment, fintech, food processing, health and wellness, industry 4.0, security, space and transport and travel. ]]> https://biospectrumindia.com/news/22/20328/govt-organises-national-innovation-week-to-address-upcoming-challenges.html https://biospectrumindia.com/news/22/20328/govt-organises-national-innovation-week-to-address-upcoming-challenges.html Mon, 10 Jan 2022 00:00:00 +0530 To commemorate 75th years of progressive India 'Azadi Ka Amrit Mahotsav', Ministry of Education (MoE), AICTE and Ministry of Commerce& Industry (DPIIT) are jointly organising ‘National Innovation Week’ from 10th – 16th Jan 2022. The innovation week is also the iconic week of Ministry of Education. This Innovation week will highlight various initiatives undertaken by these agencies to spread awareness to promote innovation and entrepreneurship in India. A 2 days long e- Symposium on ‘Building Innovation Ecosystem in Educational Institutions’ will be held on 11th and 12th January 2022 by the Ministry of Education.  From 10th January onwards, 75 innovative technologies selected from various programs such as National Innovation Contest, Smart India Hackathon, YUKTI2.0 and Toycathon conducted by the Ministry of Education will participate in e-exhibition and demonstrate their innovations. Dr Abhay Jere, Chief Innovation Officer, Innovation Cell, Ministry of Education said that the Innovation Week is an opportunity for all innovators to showcase their work and inspire the young minds to take their entrepreneurial journey more seriously so that India can emerge as a global 'Innovation and Startups hub'.  ]]> https://biospectrumindia.com/news/22/20297/pm-modi-lays-foundation-stone-of-cancer-hospital-in-imphal.html https://biospectrumindia.com/news/22/20297/pm-modi-lays-foundation-stone-of-cancer-hospital-in-imphal.html Tue, 04 Jan 2022 16:05:00 +0530 Prime Minister (PM) Narendra Modi recently laid the foundation stone of a state-of-the-art cancer hospital in Imphal worth around Rs 160 crore on a PPP basis. He inaugurated a 200-bedded covid hospital at Kiyamgei which has been set up at a cost of about Rs 37 crore in collaboration with DRDO. The PM also laid the foundation stone of ‘Centre for Invention, Innovation, Incubation and Training (CIIIT)’ to be built in the state at a cost of about Rs 200 crore. The PM is on a visit to Manipur and where he inaugurated 13 Projects worth around Rs 1850 crores and laid the foundation stone of nine projects worth around Rs 2950 crore in Imphal, Manipur.   ]]> https://biospectrumindia.com/news/22/20271/dcgi-issues-eua-to-launch-mercks-covid-19-pill-in-india.html https://biospectrumindia.com/news/22/20271/dcgi-issues-eua-to-launch-mercks-covid-19-pill-in-india.html Wed, 29 Dec 2021 00:00:00 +0530 Emergency Use Authorisation (EUA) permission by the Drug Controller General of India (DCGI) has been issued for the launch of Merck and Ridgeback's Molnupiravir in the country. DCGI, based on the review of clinical data of Molnupiravir, has approved the drug for the treatment of COVID-19 in adults for restricted emergency use in India. Cipla plans to launch Molnupiravir under the brand name Cipmolnu, while Torrent Pharma is introducing it under the brand name Molnutor, following DCGI's approval. Cipla will soon make Cipmolnu 200mg capsules available at all leading pharmacies and COVID-19 treatment centers across the country. Further, Sun Pharma will be manufacturing and marketing the drug under the brand name Molxvir. Earlier in the year, Cipla, Torrent Pharma, Sun Pharma had entered into a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir in India and to over 100 low and middle-income countries (LMICs).  ]]> https://biospectrumindia.com/news/22/20261/dcgi-approves-biological-es-protein-sub-unit-covid-19-vaccine.html https://biospectrumindia.com/news/22/20261/dcgi-approves-biological-es-protein-sub-unit-covid-19-vaccine.html Tue, 28 Dec 2021 00:00:00 +0530 Hyderabad-based Biological E has announced that its CORBEVAXTM, India’s first indigenously developed protein sub-unit vaccine against COVID-19, has received the approval from the Drugs Controller General of India (DGCI). CORBEVAXTM is a “recombinant protein sub-unit” vaccine, developed from the receptor binding domain (RBD) of the spike protein on the virus’s surface combined with Dynavax’s CpG 1018 adjuvant with alum, which helps the body build the immune response against the virus. The vaccine has been developed by Biological E. Limited in collaboration with Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine (Baylor) in Houston, Texas. The vaccine will be effective both in scale and affordability, providing sustainable access to low-and middle-income countries. Biological E. Limited's CORBEVAXTM has completed two Phase III clinical trials involving more than 3000 subjects between the ages of 18 and 80 at 33 study sites across India. The vaccine was found to be safe, well tolerated and immunogenic. Biological E. Limited plans to complete production at a rate of 75 Million doses per month, anticipating 100+ million doses per month from February 2022. These capacities will enable the Hyderabad-based company to deliver 300 Million doses as promised to the Government of India. Soon, the company plans to deliver more than one billion additional doses globally. ]]> https://biospectrumindia.com/news/22/20255/up-assam-telangana-lead-way-in-4rth-state-health-index-by-niti-aayog.html https://biospectrumindia.com/news/22/20255/up-assam-telangana-lead-way-in-4rth-state-health-index-by-niti-aayog.html Mon, 27 Dec 2021 00:00:00 +0530 NITI Aayog has released the fourth edition of the State Health Index for 2019–20. The report, titled “Healthy States, Progressive India”, ranks states and Union Territories on their year-on-year incremental performance in health outcomes as well as their overall status. Round IV of the report focuses on measuring and highlighting the overall performance and incremental improvement of states and UTs over the period 2018–19 to 2019–20. To ensure comparison among similar entities, the ranking is categorized as ‘Larger States’, ‘Smaller States’ and ‘Union Territories’. Among the ‘Larger States’, in terms of annual incremental performance, Uttar Pradesh (UP), Assam and Telangana are the top three ranking states. Among ‘Smaller States’, Mizoram and Meghalaya registered the maximum annual incremental progress. While among UTs, Delhi, followed by Jammu and Kashmir, showed the best incremental performance. On overall ranking based on the composite index score in 2019–20, the top-ranking states were Kerala and Tamil Nadu among the ‘Larger States’, Mizoram and Tripura among the ‘Smaller States’, and DH&DD and Chandigarh among the UTs. "States are beginning to take cognizance of indices such as the State Health Index and use them in their policymaking and resource allocation. This report is an example of both competitive and cooperative federalism", said NITI Aayog Vice Chairman Dr Rajiv Kumar.   ]]> https://biospectrumindia.com/news/22/20247/ayush-ministry-boosts-healthcare-facilities-in-up-with-rs-553-36-cr-investment.html https://biospectrumindia.com/news/22/20247/ayush-ministry-boosts-healthcare-facilities-in-up-with-rs-553-36-cr-investment.html Fri, 24 Dec 2021 00:00:00 +0530 The Ministry of AYUSH has announced a slew of major initiatives to push healthcare facilities in the state of Uttar Pradesh (UP). A total amount of Rs 553.36 crore has been released by the Government of India to Uttar Pradesh for various activities under the National AYUSH Mission. These major announcements were made by Union Minister of AYUSH and Ports, Shipping & Waterways Sarbananda Sonowal in the presence of Chief Minister of Uttar Pradesh, Yogi Adityanath. In an effort towards building a sustainable, effective and affordable healthcare in the country, eight new 50 bedded integrated AYUSH hospitals were inaugurated. These are located in Deoria, Koushambi, Sonbhadra, Lucknow, Kanpur, Sant Kabir Nagar, Kanpur Dehat, and Lalitpur. These were built with a total capital outlay of Rs 72 crores. A total of 500 new AYUSH Health & Wellness Centres (HWCs) were also inaugurated in different parts of the state.  Building upon this strong foundation of healthcare for people, the Union Minister laid foundation stone for a new AYUSH Educational Institute for Ayurveda with a capital outlay Rs 49.83 crores. This new institute of Ayurveda will come up in Ayodhya. Further, foundation stones were also laid for six new 50 bedded hospitals which will come up in Unnao, Shrawasti, Hardoi, Gorakhpur, Sambhal and Mirzapur. The total outlay for this project is planned at Rs 78 crores. A total of 250 new AYUSH dispensaries will also be constructed in different districts of the state.   ]]> https://biospectrumindia.com/news/22/20235/health-minister-inaugurates-national-oxygen-stewardship-programme-in-delhi.html https://biospectrumindia.com/news/22/20235/health-minister-inaugurates-national-oxygen-stewardship-programme-in-delhi.html Wed, 22 Dec 2021 00:00:00 +0530 Taking cognisance of the role of medical oxygen as a life-saving public health commodity and the need for capacity building of healthcare workers in handling of medical oxygen, Dr Bharati Pravin Pawar, Union Minister of State for Health and Family Welfare has inaugurated the National Oxygen Stewardship Programme of the Union Health Ministry, at AIIMS, New Delhi. The initiative aims to empower all healthcare workers engaged in oxygen management and administration with the essential knowledge and skills to ensure rational utilization and avoid any wastage of medical oxygen, especially in resource constraint settings. It envisages to identify and train at least one “Oxygen Steward” in each district across the country. These trained professionals would be responsible for leading the training on oxygen therapy and management in their respective districts and also support audit of oxygen delivery and preparedness for a surge scenario. "This will train our participants to avoid wastage or overuse of oxygen in resource constraint settings including issues faced during oxygen crisis, learnings, and averting further crisis situations", the Miniter stated. ]]> https://biospectrumindia.com/news/22/20156/experts-call-for-new-health-policy-to-prevent-disability-due-to-snake-bite-.html https://biospectrumindia.com/news/22/20156/experts-call-for-new-health-policy-to-prevent-disability-due-to-snake-bite-.html Wed, 08 Dec 2021 17:00:00 +0530 Minister of State for Social Justice and Empowerment Ramdas Athawale highlighted the need for a new health policy to tackle snake bite disabilities.Public health experts, policymakers and administrators gathered at a policy roundtable on Snakebite & Disability, organised by Integrated Health & Wellbeing (IHW) Council and powered by Bharat Serums & Vaccines (BSV), to underline the requirement of spreading awareness on means to prevent disability caused due to snakebite on the occasion of the International Day of Persons with Disability (on 3rd December).  “From 2000 to 2019 1.2 million people died due to the snakebite, whereas, in India, approximately 58,000 people die every year due to snakebite. This grave issue needs special emphasis from the government. New technologies need to be invented to deal with it. Local people, who take out the venom, should be encouraged. A new policy should be made to deal with this health crisis due to the snakebite,” said Athawale.Urvashi Prasad, Director, DMEO, Niti Aayog outlined the need for strengthening the infrastructure of the primary healthcare centres, which are the first point of contact in such cases. "We need to recognise the fact that disability is perhaps the more important outcome in snakebite envenoming than death itself,” said Dr David Williams, Technical Officer (Antivenoms) vaccines, WHO. However, Chetan Raj Singh, Vice President-Critical Care & Emergency Medical, Bharat Serums & Vaccines said there is no dearth of anti-venom medicines in India but of trained doctors.  "Doctors at the community health centres and the primary health centres need to be trained”, he said. Dr Maya Gopal Krishnan, Assistant Professor, Department of Medicine, AIIMS, Jodhpur said, “The patients simply need a blood clotting test. Snakebite can produce multiple disabilities of various organ systems. These kinds of disabilities can lead to kidney disease. Around 25 to 30 per cent are going through acute kidney injury besides blindness.” ]]> https://biospectrumindia.com/news/22/20125/nmpb-cimap-lucknow-ink-mou-to-promote-production-of-medicinal-plants.html https://biospectrumindia.com/news/22/20125/nmpb-cimap-lucknow-ink-mou-to-promote-production-of-medicinal-plants.html Mon, 06 Dec 2021 12:50:00 +0530 The National Medicinal Plants Board (NMPB) and the Council of Scientific and Industrial Research-Central Institute of Medicinal and Aromatic Plants, (CSIR-CIMAP), Lucknow have signed an MoU for extending joint collaborative efforts to promote the production of quality planting material (QPM) of medicinal plants.   The MoU will facilitate the development of QPM of medicinal plants and herbs identified by NMPB and help in the establishment of the nurseries for QPM development, promotion, conservation and cultivation of the appropriate medicinal plants in different agro-climatic zones. CSIR-CIMAP Lucknow can also research mass multiplication, agro-technology development, quality planting material generation of selected medicinal plants and herbs.   Working under the Ministry of Ayush, NMPB is mandated to coordinate all matters relating to medicinal plants and support policies and programmes for the growth of trade, export, conservation and cultivation of medicinal plants.     ]]> https://biospectrumindia.com/news/22/20124/ayush-minister-inaugurates-50-bed-hospital-in-moreh-manipur.html https://biospectrumindia.com/news/22/20124/ayush-minister-inaugurates-50-bed-hospital-in-moreh-manipur.html Mon, 06 Dec 2021 11:15:00 +0530 Union Minister of Ayush and Ports, Shipping & Waterways Sarbananda Sonowal inaugurated a 50-bed integrated Ayush hospital in Moreh, Manipur through virtual medium and announced major initiatives for the development and promotion of the AYUSH industry in Manipur.    Addressing a press briefing the Union Minister stated that the ministry has decided to develop 15 AYUSH dispensaries, seven 10-bed hospitals, 100 school herbal gardens, 16 nurseries in each district and 50 Health and Wellness Centres (HWCs) in the state.   The Union Minister was attending a programme on ‘Phytopharmaceutical Mission to promote the documentation, scientific validation and evaluation of traditional healthcare practices of North-East India’ in Imphal as Special Guest of Honour. Manipur Chief Minister N Biren Singh, Union MoS Dr RK Ranjan Singh, Advisor to CM (Health), Manipur, Dr S Ranjan Singh also attended the function. ]]> https://biospectrumindia.com/news/22/20042/nha-invites-comments-on-health-data-retention-policy-consultation-paper.html https://biospectrumindia.com/news/22/20042/nha-invites-comments-on-health-data-retention-policy-consultation-paper.html Wed, 24 Nov 2021 13:45:00 +0530 The National Health Authority (NHA) released a consultation paper on the proposed Health Data Retention Policy. The consultation paper provides a detailed discussion on the need for the policy, its scope, key elements under it, and proposed approach for its governance structure under the ambit of Ayushman Bharat Digital Mission (ABDM). It also focuses on how a health data retention policy for ABDM stakeholders will help the healthcare ecosystem.   The proposed Health Data Retention Guideline/Policy has been envisioned to minimise risks associated with personal health data and to maximise benefits from the usage of this data by ensuring that data retention guidelines are in sync with all applicable legal and regulatory compliances. The NHA will ensure an inclusive engagement with stakeholders and ensure that all diverse viewpoints are incorporated from concerned stakeholders.   Through this consultation paper, the NHA is providing interested stakeholders with information that may be useful to understand the considerations for the proposed policy for India, and its related implications, and seek their suggestions/inputs on health data retention under ABDM.   Full text of the consultation paper is available for download on ABDM’s website at https://abdm.gov.in/publication/consultationpapers. Comments and feedback can be uploaded on the same link or can be emailed to abdm@nha.gov.in by December 24, 2021.   NHA is also planning to organise a public webinar shortly to provide an overview of the consultation paper. ]]> https://biospectrumindia.com/news/22/20041/india-adb-sign-300-m-loan-to-improve-primary-healthcare.html https://biospectrumindia.com/news/22/20041/india-adb-sign-300-m-loan-to-improve-primary-healthcare.html Wed, 24 Nov 2021 13:35:00 +0530 The Government of India and the Asian Development Bank (ADB) have signed a $300 million loan to strengthen and improve access to comprehensive primary health care in urban areas of 13 states that will benefit over 256 million urban dwellers including 51 million from slum areas.   Rajat Kumar Mishra, Additional Secretary, Department of Economic Affairs in the Ministry of Finance, signed for the Government of India the agreement for Strengthening Comprehensive Primary Health Care and pandemic preparedness in Urban Areas Program while Takeo Konishi, Country Director of ADB’s India Resident Mission, signed for ADB.   The programme will be implemented in urban areas across 13 states: Andhra Pradesh, Assam, Chhattisgarh, Gujarat, Haryana, Jharkhand, Karnataka, Madhya Pradesh, Maharashtra, Rajasthan, Tamil Nadu, Telangana, and West Bengal.   Besides the pandemic response, interventions through the programme promote increased utilisation of urban HWCs with the provision of comprehensive primary health care packages including non-communicable diseases and community outreach services such as awareness-raising activities on health care options, particularly for women.   Delivery and health information systems for primary health care will be upgraded through digital tools, quality assurance mechanisms, and engagement and partnership with the private sector.     The programme is supported by a $2 million technical assistance grant from ADB’s Japan Fund for Poverty Reduction to provide support for programme implementation and coordination, capacity building, innovation, knowledge sharing and application of scalable best practices across the healthcare system. ]]> https://biospectrumindia.com/news/22/20028/us-india-discuss-ip-led-solutions-over-global-pandemic.html https://biospectrumindia.com/news/22/20028/us-india-discuss-ip-led-solutions-over-global-pandemic.html Mon, 22 Nov 2021 16:45:00 +0530 The US Chamber of Commerce’s Global Innovation Policy Center (GIPC) and US-India Business Council, in partnership with the Federation of Indian Chambers of Commerce and Industry (FICCI), convened government and industry leaders for the final session of its 4th annual IP Dialogue. Although the global pandemic continues to affect millions, this year’s dialogue proved to be incredibly impactful, with intellectual property playing such a key role in efforts to study and combat the ongoing global pandemic.   “IP Dialogue: Opportunities for US-India Collaboration” featured experts from India’s Department for Promotion of Industry and Internal Trade (DPIIT), US Patent and Trademark Office, US International Trade Administration, US Department of State, and Office of the US Trade Representative, along with other government, private sector, and academic experts. Participants discussed a broad range of IP-related topics, including how to support IP commercialisation, challenges in fighting the global pandemic, barriers to domestic innovation, and the “next generation” of IP policy discussions in the digital economy.    "India has long been a hub for research, development, and manufacturing of biopharmaceutical products—complementing similar work underway in the US. The IP Dialogue is a means by which these two countries can not only discuss shared goals but ways to get there,” said Patrick Kilbride, Senior VP of the US Chamber’s Global Innovation Policy Center.     “Intellectual property protections undergird our modern economy—from the digital platforms we use to the content we enjoy and everything in between. The U.S. Chamber is excited about India’s plan to create a $1 trillion digital economy—and to assist in the exchange of best practices and knowledge, we host the US-India IP Dialogue,” said Nisha Biswal, President, US Chamber’s US-India Business Council.   Dialogue recommendations will be shared with both governments to deepen strategic cooperation on IP policy.    ]]> https://biospectrumindia.com/news/22/20006/pm-calls-for-ideate-innovate-in-india-at-global-innovation-summit-2021.html https://biospectrumindia.com/news/22/20006/pm-calls-for-ideate-innovate-in-india-at-global-innovation-summit-2021.html Thu, 18 Nov 2021 00:00:00 +0530 Prime Minister Narendra Modi unveiled the ‘ Global Innovation Summit-2021’, organized by Indian Pharmaceutical Alliance (IPA) and its partners to bring together world leaders from across different stakeholder groups including government, industry, academia, investors, and researchers to discuss and strategize priorities to foster a thriving innovation ecosystem that will enable Indian pharmaceutical industry to further consolidate its position as a global leader and become an innovation hub for the world. Modi said, “I invite everyone to ideate in India, innovate in India and make in India and make for the world. Discover your true strength and serve the world. We have the talent, resources and the ecosystem required for innovation and enterprise. Our rapid strides, our speed of innovation and the scale of our achievements in the pharma sector have been noticed by the world. This is the best time to move forward and scale new heights.” Union Minister for Health & Family Welfare and Minister of Chemicals and Fertilizers, Dr Mansukh Mandaviya said, “I am very confident that India will achieve a very ambitious target of $130 billion pharma industry by 2030.”  The meet witnessed a robust discussion on the approach to innovation in the pharma industry and ways to create a positive impact on health and healthcare. The event covered discussions on creating an enabling regulatory landscape, funding support, linkages between academia and industry and high-quality infrastructure setup. The Indian pharma industry aspires to grow to $120-130 billion from the current value of $44 billion over the next decade, increasing its contribution to GDP by 100 basis points. Keeping this in perspective, the event took stock of and discussed recommendations to improve the innovation landscape in India; sharing learnings and emerging trends in the global innovation landscape; providing a platform for innovation start-ups to showcase their ideas and achievements; and showcasing exciting local research to support “Discover in India” and enhance access.     ]]> https://biospectrumindia.com/news/22/19962/govt-to-set-up-vaccine-testing-research-facility-at-rgcb-in-kerala.html https://biospectrumindia.com/news/22/19962/govt-to-set-up-vaccine-testing-research-facility-at-rgcb-in-kerala.html Fri, 12 Nov 2021 19:00:00 +0530 Union Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr Jitendra Singh informed that one lakh genome and DNA sequencing has been done for COVID-19 so far by the Department of Bio-Technology (DBT) and 5 COVID-19 Biorepositories with 57,000 samples were made available to academia and industry for R&D and Product development. Dr Singh announced that a vaccine testing and research facility will come up at the second campus of the Rajiv Gandhi Centre for Biotechnology (RGCB) in Kerala. The centre will have a BSL 3 facility that is capable of handling airborne viruses like COVID-19. The facility will be the first of its kind in South India. The Minister was presiding over a high-level meeting to review the current status of COVID-19 research, development of vaccines and other protocols as well as the contribution made in this direction by each of the autonomous institutions of the Department of Biotechnology located in different parts of the country.   ]]> https://biospectrumindia.com/news/22/19961/usaid-unveils-india-centric-project-to-engage-youth-in-reproductive-health-wellbeing.html https://biospectrumindia.com/news/22/19961/usaid-unveils-india-centric-project-to-engage-youth-in-reproductive-health-wellbeing.html Fri, 12 Nov 2021 18:10:00 +0530 The US Agency for International Development (USAID) under its MOMENTUM Country and Global Leadership mechanism, announced a new initiative for India, MOMENTUM Country and Global Leadership: India-Yash, to engage adolescents and youth in decisions about their reproductive health and wellbeing. Through this four-year project, MOMENTUM Country and Global Leadership: India-Yash will focus on family planning (FP) and reproductive health (RH) for young people and contribute to the achievement of India’s national FP goals. The project will support the FP/RH needs of India’s marginalized youth in urban and rural areas of Assam, Jharkhand, Odisha, Chhattisgarh and Madhya Pradesh. Speaking at the event, Dr SK Sikdar, Advisor, FP & MINH, Ministry of Health & Family Welfare Government of India said, "We are confident that the Yash programme will play a crucial role in the achievement of socioeconomic and environmental development goals for sustainable development." Sangita Patel, Director Health Office, USAID/India said, “MOMENTUM Country and Global Leadership India-Yash is designed to build upon existing evidence and best practices, as well as to catalyse new ideas and partnerships, using a targeted, contextualised approach."   ]]> https://biospectrumindia.com/news/22/19943/health-ministry-expanding-tb-care-through-engagement-of-various-stakeholders.html https://biospectrumindia.com/news/22/19943/health-ministry-expanding-tb-care-through-engagement-of-various-stakeholders.html Wed, 10 Nov 2021 19:15:00 +0530 Union Minister of State for Health and Family Welfare, Dr Bharati Pravin Pawar chaired the brainstorming session on Strategies for Ending TB by 2025.   Dr Pawar said, “We have a mere 37 months before the deadline to end TB in the country. We need to shift gears and come up with innovative solutions to make up for the setbacks due to COVID-19 and move beyond.”    The session focused on five pillars including improving case detection, improving treatment adherence, evolving ways to converge with other social welfare programmes, utilising and refining private sector engagement and finally integration of National TB Elimination Program (NTEP) within our health system for accelerating TB eradication in the country.    Highlighting the Union Government’s efforts for TB eradication, she added: “TB has now been made an essential part of Comprehensive Primary Health Care and is integrated with Ayushman Bharat scheme. Our aim is to detect cases early and prevent the emergence of new cases of TB by expanding TB care through engagement of various stakeholders, including the community.   Dr Pawar said, “TB preventive treatment has been prioritised under the pillar of 'Prevent' in the National Strategic Plan to end TB. Scaling up TB Preventive Treatment and at the same time decentralising it to bring services closer to patients, are of utmost importance to break the chain of transmission and breakdown of those with TB infection into full-blown TB disease.”     ]]> https://biospectrumindia.com/news/22/19930/government-opens-biotech-centre-at-kimin-arunachal-pradesh.html https://biospectrumindia.com/news/22/19930/government-opens-biotech-centre-at-kimin-arunachal-pradesh.html Tue, 09 Nov 2021 15:35:00 +0530 Union Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr Jitendra Singh has inaugurated a new Biotechnology Centre for Northeast tribals in a remote area of Arunachal Pradesh at Kimin.  The Centre aims at conservation and sustainable utilization of the local bio-resources using biotechnological tools and is ably supported by Department of Biotechnology (DBT), Ministry of Science and Technology, the Minister added. Dr Jitendra Singh also dedicated DBT-funded Skill Vigyan Programme in Biotechnology to the state of Arunachal Pradesh during the event.  Dr Singh informed that the programme is the focussed endeavour towards building synergies with Skill Vigyan and Accelerate Vigyan initiatives of the Government of India as it aims at facilitating the development of career paths for young graduates in life sciences/biotechnology by skilling them through hands-on practices for creating quality job opportunities as well as Entrepreneurship Developments including capacity building of young faculty members in the key STI domains.  Four different types of training programmes are being implemented which include (1) Students Training Programme (STP), (2) Technician Training Programme (TTP), (3) Faculty Training Programme (FTP) and (4) Entrepreneurship Development Programme (EDP).        ]]> https://biospectrumindia.com/news/22/19913/dcgi-approves-ph-3-trial-of-us-based-inovios-dna-vaccine-candidate-for-covid-19.html https://biospectrumindia.com/news/22/19913/dcgi-approves-ph-3-trial-of-us-based-inovios-dna-vaccine-candidate-for-covid-19.html Fri, 05 Nov 2021 00:00:00 +0530 US-based Inovio Pharma has received authorization from the Central Drugs Standard Control Organization (CDSCO)'s Drug Controller General of India (DCGI) to proceed with the Phase 3 segment of INOVIO's global Phase 2/3 trial, INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), in India for INO-4800, its DNA vaccine candidate for COVID-19. Inovio is partnering with Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) to conduct the INNOVATE Phase 3 segment in multiple countries in Latin America, Asia, and Africa. Regulatory authorization in India follows authorizations from health authorities in Brazil, Philippines, Mexico and Colombia. The global Phase 3 segment of INNOVATE will evaluate the efficacy of INO-4800 in a two-dose regimen (2.0 mg per dose), administered one month apart, in a 2-to-1 randomization in men and non-pregnant women 18 years of age and older. The primary endpoint of this case-driven Phase 3 trial is virologically confirmed symptomatic COVID-19. As one of the only nucleic-acid based vaccines that is stable at room temperature for more than a year, at 37°C for more than a month, has a five-year projected shelf life at normal refrigeration temperature and does not need to be frozen during transport or storage, INO-4800 is anticipated to be well-positioned for a primary series immunization as well as a booster. ]]> https://biospectrumindia.com/news/22/19888/india-world-bank-ink-agreement-to-strengthen-health-systems-in-meghalaya.html https://biospectrumindia.com/news/22/19888/india-world-bank-ink-agreement-to-strengthen-health-systems-in-meghalaya.html Mon, 01 Nov 2021 12:40:00 +0530 The Government of India, the Government of Meghalaya and the World Bank recently signed a $40 million health project for the state of Meghalaya. The project will improve the quality of health services and strengthen the state’s capacity to handle future health emergencies, including the COVID-19 pandemic.   The Meghalaya Health Systems Strengthening Project will enhance the management and governance capabilities of the state and its health facilities; expand the design and coverage of the state’s health insurance program; improve the quality of health services through certification and better human resource systems, and enable efficient access to medicines and diagnostics.   All 11 districts of the state will benefit from the project. It will also benefit health sector staff at the primary and secondary levels by strengthening their planning and management capabilities and building their clinical skills. The project will enable women to better utilise healthcare services at the community level.   The agreement was signed by Rajat Kumar Mishra, Additional Secretary, Department of Economic Affairs, Ministry of Finance on behalf of the Government of India; Ramkumar S, Joint Secretary, Department of Health and Family Welfare on behalf of the Government of Meghalaya; and Junaid Ahmad, Country Director, India on behalf of the World Bank.   The project will move towards a performance-based financing system where Internal Performance Agreements (IPAs) between the DoHFW and its subsidiaries would foster more accountability at all levels. This is expected to go a long way in improving the management of the system to deliver quality health services. The project will also focus on promoting synergy between various schemes and augmenting the capacity of the state insurance agency.     ]]> https://biospectrumindia.com/news/22/19878/govt-launches-nationwide-expansion-of-pneumococcal-conjugate-vaccine-under-uip.html https://biospectrumindia.com/news/22/19878/govt-launches-nationwide-expansion-of-pneumococcal-conjugate-vaccine-under-uip.html Fri, 29 Oct 2021 15:40:00 +0530 Union Minister for Health and Family Welfare, Dr Mansukh Mandaviya has launched the nationwide expansion of Pneumococcal Conjugate Vaccine (PCV) under the Universal Immunization Programme (UIP) as a part of Azadi ka Amrit Mahotsav. Addressing the nation-wide rollout, the Union Minister said that it is for the first time in the country that PCV will be available for universal use The Minister also released communication and awareness packages on PCV to create widespread mass awareness. These communication packages will be shared with all states/UTs for further adaptation and utilisation. The Union Health Minister congratulated all the immunisation staff, healthcare workers and officials for their efforts in the rollout of this life-saving vaccine. While releasing the communication package for the vaccine, Dr Mandaviya exhorted that creating awareness regarding the vaccine is a vital component. The objective of the vaccine is to save the lives of our children and this would be possible if we run a successful awareness campaign across the country.   ]]> https://biospectrumindia.com/news/22/19871/india-has-potential-to-become-hub-of-international-health-tourism-dr-mansukh-mandaviya-.html https://biospectrumindia.com/news/22/19871/india-has-potential-to-become-hub-of-international-health-tourism-dr-mansukh-mandaviya-.html Thu, 28 Oct 2021 17:20:00 +0530 Union Minister for Health and Family Welfare Dr Mansukh Mandaviya addressed the inaugural session of CII Asia Health 2021 Summit, on 28th October. The theme of the summit is ‘Transforming Healthcare for a better tomorrow’. The event was also attended by Dr Vinod K Paul, Member, NITI Aayog, Dr RS Sharma, CEO, National Health Authority along with the key officials of CII.Emphasising that preventive care is an essential component of the health sector, he said that initiatives like Khelo India, Yoga etc play a vital role in realising the aim of a healthy society.He added that the Government is focusing on the theme of ‘From Token to Total Health’. PM Ayushman Bharat Health Infrastructure Mission will help in strengthening the healthcare infrastructure of the country. Highlighting the need to link technology and healthcare, Dr Mandaviya mentioned that there is a need to adopt the latest technologies like Nano and robotic technologies in the health sector. He further added that the Indian health sector has immense investment opportunities. Urging the private sector to invest in the Indian healthcare sector, he said that India has the potential to become a hub of international health tourism. The Minister concluded by highlighting that the government is focused on the objective of ‘Health Society, Wealthy Nation’ and will work tirelessly to ensure the same in the country. ]]> https://biospectrumindia.com/news/22/19857/union-health-minister-addresses-pharma-medtech-opportunities-at-investor-summit.html https://biospectrumindia.com/news/22/19857/union-health-minister-addresses-pharma-medtech-opportunities-at-investor-summit.html Wed, 27 Oct 2021 17:00:00 +0530 Union Minister for Health and Family Welfare and Chemicals & Fertilizers Dr Mansukh Mandaviya inaugurated and addressed the Investor Summit - 'Opportunities and Partnerships in Pharmaceuticals & Medical Devices' via video conferencing, on 27 October.  The summit was organised by the Department of Pharmaceuticals, in partnership with Invest India as part of the vision to further strengthen India’s position globally in terms of pharma and medical devices. Enlisting the various policies, schemes and initiatives of the government to encourage pharma industries, Dr Mandaviya said that Production Linked Incentive (PLI) scheme for the pharma sector will give a boost to the industry and has the potential to make India a pharma hub. He underlined the fact that India is going to become a huge market for medicines and medical devices. India strives to become the best investment destination in the world for pharma sector. The sector has witnessed a substantial increase in investments. FDI increased 98% year on year in 2020. Pharma exports from India grew by 18% in the last financial year, he added.     ]]> https://biospectrumindia.com/news/22/19832/govt-launches-pm-ayushman-bharat-health-infrastructure-mission.html https://biospectrumindia.com/news/22/19832/govt-launches-pm-ayushman-bharat-health-infrastructure-mission.html Mon, 25 Oct 2021 15:40:00 +0530 Prime Minister Narendra Modi launched PM Ayushman Bharat Health Infrastructure Mission on 25 October. He also inaugurated various development projects worth around Rs 5200 crore for Varanasi.   Describing the initiative taken by the government under the new Mission, the Prime Minister said that there are three major aspects of the Ayushman Bharat Health Infrastructure Mission to address the different gaps in the health sector of the country.   The first is related to the creation of elaborate facilities for diagnostics and treatment. Under this, Health and Wellness Centres are being opened in villages and cities, where there will be facilities for early detection of diseases. Facilities like free medical consultation, free tests, free medicine will be available in these centres. For serious illness, 35,000 new critical care-related beds are being added in 600 districts and referral facilities will be given in 125 districts.    The second aspect of the scheme is related to the testing network for the diagnosis of diseases. Under this mission, the necessary infrastructure will be developed for the diagnosis and monitoring of diseases. 730 districts of the country will get integrated public health labs and 3000 blocks will get block public health units. Apart from that, five regional national centres for disease control, 20 metropolitan units, and 15 BSL labs will further strengthen this network.   The third aspect is the expansion of existing research institutions that study pandemics. Existing 80 viral diagnostic and research labs will be strengthened, 15 biosafety level 15 labs will be operationalised, four new National Institutes of Virology and a National Institute for One Health are being established. WHO regional research platform for South Asia will also strengthen this network.     ]]> https://biospectrumindia.com/news/22/19822/technology-in-health-sector-has-to-be-inclusive-frugal-user-friendly-nha.html https://biospectrumindia.com/news/22/19822/technology-in-health-sector-has-to-be-inclusive-frugal-user-friendly-nha.html Fri, 22 Oct 2021 17:40:00 +0530 Unified Payments Interface (UPI) has become an extremely successful and scalable platform. It is a simple single dimension money transfer system. Health provisioning has hundreds and thousands of stakeholders - small clinics, large hospitals, technology-savvy hospitals, pharmacies, diagnosticians and laboratories. This information was delivered by Dr Ram Sewak Sharma, Chief Executive Officer, National Health Authority (NHA), Ministry of Health & Family Welfare, Government of India.Speaking at the Public Affairs Forum of India (PAFI)’s 8th National Forum that was held virtually on 'Reviving the Economy: Reimagine. Reboot. Reform', on 22 October, Dr Sharma explained that technology in the health sector has to be inclusive, cater to diversity, interoperable, scalable, frugal, user-friendly, not become an additional burden on a doctor’s part and easy to integrate into the workflow. Above all, it should be people-centric. Dr Randeep Guleria, Director, AIIMS advocated, “We have to adapt to technology as per the needs of the health sector." He also cited the need to address health as equity and invest more in research and entrepreneurship. A well structured adequately-financed PPP plan, he feels, can become a defining moment for the health sector. Deepshikha Dharmaraj, Managing Committee Member, PAFI and Chief Executive Officer, Genesis BCW Member, BCW India Board introduced the session and shared how India's one billion vaccine milestone reiterates the strength of India's healthcare sector and the spirit of partnership between the government and industry. ]]> https://biospectrumindia.com/news/22/19802/ppps-crucial-to-create-sustainable-long-term-model-of-health-system-dr-bharati-pravin-pawar.html https://biospectrumindia.com/news/22/19802/ppps-crucial-to-create-sustainable-long-term-model-of-health-system-dr-bharati-pravin-pawar.html Wed, 20 Oct 2021 17:15:00 +0530 Dr Bharati Pravin Pawar, Minister of State, Ministry of Health and Family Welfare, Government of India, said that the COVID-19 pandemic has highlighted gaps in the Indian healthcare system which offers a distinctive opportunity to transform it through the private-public partnership.Addressing the FICCI Healthcare Excellence Awards at the FICCI Heal 2021 event, Dr Pawar said, PPP in healthcare has the potential to resolve the issues and ensure healthcare inclusion for the Indian masses and create a sustainable long-term model.CK Mishra, Former Secretary, Government of India said, India has demonstrated its manufacturing capacity during COVID-19 and unique healthcare handling capacity. He further mentioned that FICCI has played the role of a bridge between the industry and government.Subhrakant Panda, Vice President, FICCI said we are proud to felicitate organisations and individuals for their efforts and exemplary contributions in the healthcare sector.Dr Narottam Puri, Advisor- FICCI Health Services Committee; Board Member & Former Chairman- NABH; Advisor- FICCI Health Services & MVT; Hony. Professor & Advisor-IMA; Advisor-Medical Operations, Fortis Healthcare said the FICCI Annual Healthcare Awards aims to encourage and recognise the tremendous contributions of the healthcare providers by innovating for increased efficiency, affordability and improved performance of healthcare delivery.Dilip Chenoy, Secretary-General, FICCI said the awards are indeed special when the world is going through difficult times and the importance of healthcare workers is of supreme importance. ]]> https://biospectrumindia.com/news/22/19799/industry-must-reposition-to-align-with-pm-jay-dr-vk-paul-member-niti-aayog.html https://biospectrumindia.com/news/22/19799/industry-must-reposition-to-align-with-pm-jay-dr-vk-paul-member-niti-aayog.html Wed, 20 Oct 2021 15:30:00 +0530 Dr VK Paul, Member, NITI Aayog said that PM JAY (Pradhan Mantri Jan Arogya Yojana) has started to absorb other government schemes and expand its scope on the initiatives of the state governments. “The central government is also willing to increase its ambit. PM JAY is here to stay, and it is the main vehicle for secondary and tertiary care and therefore we have to reposition ourselves to align with this,” he added.   Addressing the inaugural session of ‘FICCI HEAL 2021’, organised jointly with the Ministry of Health and Family Welfare and NITI Aayog, Dr Paul stated that the government will continue to refine PMJAY and all those who are not yet part of it should partner with it.    Dr Paul also shared that state governments are planning to increase their budgets on healthcare from the current 4-4.5 per cent to almost 8 per cent, which should help in getting the requisite focus on enhancing the healthcare status.    Dr Sangita Reddy, Immd. Past President, FICCI and Joint MD, Apollo Hospitals Group said, “The government recently announced the revision in the rates of Pradhan Mantri Jan Arogya Yojana- the Health Benefit Package 2.2 and this will indeed encourage more private hospitals to join hands with the government. I urge the government to include outpatient packages under the PMJAY."   Dr Alok Roy, Chair, FICCI Health Services Committee & Chairman, Medica Group of Hospitals said, "There is a need for augmenting and expanding these collaborations and advancements in innovations to a new level to help bring in the real transformation of our healthcare ecosystem."     ]]> https://biospectrumindia.com/news/22/19781/we-need-to-keep-open-supply-chains-for-vaccine-raw-materials-finance-minister.html https://biospectrumindia.com/news/22/19781/we-need-to-keep-open-supply-chains-for-vaccine-raw-materials-finance-minister.html Mon, 18 Oct 2021 00:00:00 +0530 The Group of Thirty (G30) hosted its premiere annual event, the International Banking Seminar, on Sunday, October 17. During the event, Nirmala Sitharaman, Finance Minister, Government of India underlined the need for the World Health Organisation (WHO) to be strengthened for a more effective response to new challenges. She stressed on the need to keep open supply chains for vaccine raw materials and components to help enhance vaccine production. She also highlighted the need of an international financial architecture to fight the COVID19 pandemic across the globe. The FM supported the need of new financial instruments to focus and press forward green initiatives. The Group of Thirty, established in 1978, is an independent global body comprised of economic and financial leaders from the public and private sectors and academia. It aims to deepen understanding of global economic and financial issues, and to explore the international repercussions of decisions taken in the public and private sectors. ]]> https://biospectrumindia.com/news/22/19749/ayush-ministry-promotes-production-of-medicinal-plants.html https://biospectrumindia.com/news/22/19749/ayush-ministry-promotes-production-of-medicinal-plants.html Mon, 11 Oct 2021 16:55:00 +0530 National Medicinal Plant Board (NMPB) has joined hands with the Institute of Himalayan Bioresource Technology (IHBT), based in Himachal Pradesh’s Palampur area, to promote the production of quality planting material of medicinal plants.    Established under the Ministry of Ayush, NMPB works towards supporting policies and programmes for the growth of trade, export, conservation and cultivation of medicinal plants.   The two organisations have signed a Memorandum of Understanding to facilitate the development of Quality Planting Material (QPM) of medicinal plants and herbs identified by NMPB and help in the establishment of the nurseries for QPM development, promotion, conservation and cultivation of the appropriate medicinal plants in different agro-climatic zones, including the Rare Endangered Threatened (RET) species and those growing in high-altitude regions.    The CSIR-IHBT will also undertake research on mass multiplication and agro-technology development ]]> https://biospectrumindia.com/news/22/19731/ayush-ministry-launches-online-licensing-portal-for-manufacturers-.html https://biospectrumindia.com/news/22/19731/ayush-ministry-launches-online-licensing-portal-for-manufacturers-.html Fri, 08 Oct 2021 17:50:00 +0530 The Ministry of Ayush has made the process to grant the license to manufacture Ayurveda, Siddha and Unani (ASU) drugs swift, paperless and more transparent by bringing the application system online.   Manufacturers can now save the trouble of making a physical presence at the office of the licensing authority and can now apply for the license online at www.e-aushadhi.gov.in.    The license of the ASU drugs has been made perpetual i.e. with a one-time registration fee the license of the product will be valid lifetime subject to online submission of self-compliance declaration every year or unless suspended or cancelled. While before the notification it had a validity period of five years.   The applicants will only have to get their Good Manufacturing Practices certification validated every five years to keep their license in force. The GMP certificate can also be retained with online submission of a retention fee of Rs 1000. The manufacturing unit of the ASU drugs will be subjected to inspection in a randomised manner every five years. Since the validity of the license has been increased, the license fee has also been revised from Rs 1,000 to Rs 2,000 for any number of generic ASU drugs and Rs 3000 for up to 10 proprietary ASU drugs.   The Ministry has also reduced the maximum time in granting the license from three months to two months. For six months from the date of gazette notification, both the online and offline application process will co-exist before it turns completely online.    ]]> https://biospectrumindia.com/news/22/19705/nha-revises-health-benefit-package-of-ab-pm-jay-includes-one-on-black-fungus.html https://biospectrumindia.com/news/22/19705/nha-revises-health-benefit-package-of-ab-pm-jay-includes-one-on-black-fungus.html Tue, 05 Oct 2021 00:00:00 +0530 The National Health Authority (NHA), the apex body for implementing Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) has revised the Health Benefit Package (HBP) Master under the scheme. In the revised version of Health Benefit Package (HBP 2.2), rates of some health packages have been increased by 20 percent to 400 per cent under PM-JAY. Around, 400 procedure rates have been revised and one new additional medical management package related to black fungus have also been added. According to the NHA, rate revision has been done in the following categories: (i) radiation oncology procedures, (ii) Medical Management procedures like procedure for dengue, acute febrile illness etc, (iii) surgical package treatment for black fungus, (iv) other procedures like Right/left heart catheterization, PDA closure, Arthrodesis, Cholecystectomy, appendicectomy etc. Under medical management procedures, rates for ICU with ventilator has been revised by 100 percent, rates for ICU without ventilator by 136 percent, rates for HDU has been revised by 22 percent while prices for routine ward has been revised by 17 percent. The HBP 2.2 is expected to be rolled out from November, 2021. Currently, Ayushman Bharat PM-JAY has 1669 treatment procedures out of which 1080 are surgical, 588 medical and one unspecified package.  ]]> https://biospectrumindia.com/news/22/19681/niti-aayog-accelerates-digital-innovation-in-india-in-collaboration-with-aws-intel.html https://biospectrumindia.com/news/22/19681/niti-aayog-accelerates-digital-innovation-in-india-in-collaboration-with-aws-intel.html Thu, 30 Sep 2021 00:00:00 +0530 The National Institution for Transforming India (NITI Aayog), the Government of India’s national policy think tank, Amazon Web Services (AWS), and Intel have come together to establish a new experience studio at the NITI Aayog Frontier Technologies Cloud Innovation Center (CIC). Located in NITI Aayog’s New Delhi premises, the studio will bea hub for collaboration and experimentation to enable problem solving and innovation between government stakeholders, startups, enterprises, and industry domain experts. The studio will help showcase the potential of technologies such as artificial intelligence (AI), machine learning (ML), Internet of Things (IoT), augmented reality and virtual reality (AR/ VR), blockchain, and robotics to accelerate their application in public sector use cases. The studio will encourage open innovation and serve as a hub for government, healthcare, education, and nonprofit startups from India to showcase their solutions. It will also provide startups with an option to access necessary support to enhance and scale their solutions. Startups will also be encouraged to participate actively in the studio through hackathons, grand challenges,and other capacity building initiatives, in collaboration with the Atal Innovation Mission (AIM) and Atal Incubation Centres (AIC). ]]> https://biospectrumindia.com/news/22/19638/pm-launches-ayushman-bharat-digital-mission.html https://biospectrumindia.com/news/22/19638/pm-launches-ayushman-bharat-digital-mission.html Mon, 27 Sep 2021 12:50:00 +0530 Prime Minister Narendra Modi launched the Ayushman Bharat Digital Mission through a video conference on 27 September. Speaking on the occasion, the PM said that the campaign of strengthening health facilities that have been going for the last seven years is entering a new phase today. The Prime Minister said Ayushman Bharat – Digital Mission, will now connect the digital health solutions of hospitals across the country with each other. The mission will not only make the processes of hospitals simplified but also will increase ease of living, he added. Under this, every citizen will now get a digital health ID and their health record will be digitally protected.The Prime Minister informed that India is working on a health model that is holistic and inclusive. A model which stresses preventive healthcare and, in case of disease, easy, affordable and accessible treatment. He also discussed unprecedented reforms in health education and said a much larger number of doctors and par medical manpower is being created in India now as compared to seven to eight years ago. A comprehensive network of AIIMS and other modern health institutions is being established in the country and work on establishing one medical college in every three Lok Sabha constituencies is going on. He also talked about strengthening health facilities in villages and informed that in the villages, primary health centre networks and wellness centres are being strengthened. More than 80,000 such centres have already been operationalised, said the Prime Minister. ]]> https://biospectrumindia.com/news/22/19630/union-chemicals-fertilisers-minister-presents-icc-annual-awards-for-year-2020.html https://biospectrumindia.com/news/22/19630/union-chemicals-fertilisers-minister-presents-icc-annual-awards-for-year-2020.html Sat, 25 Sep 2021 13:15:00 +0530 Union Minister for Health and Family Welfare and Chemicals & Fertilisers Mansukh Mandaviya presented the ICC (Indian Chemical Council) Annual Awards for the year 2020 in a virtual ceremony. He also launched the latest Edition of the Members Directory. The edition of the directory contains detailed information of all the members of the council.   He appreciated the role of chemical industry in the fight against COVID pandemic. “It immensely helps the pharma sector and forms the bedrock of current vaccination drive,” he added. Emphasising the need for more R&D in this sector, he said that chemical industry is a knowledge intensive sector; hence industry and academic institutions should collaborate for further research. He said that there is huge potential of investment in India and chemical industry needs to follow a cluster approach.    Samir Biswas, Additional Secretary, Ministry of Chemicals & Fertilisers, Dr Martin Brudermüller President, ICCA &Chairman of the Board of Executive Directors of BASF SE, Ravi Goenka, President, ICC, and other senior officers of the ministry were also present.    Dr Santrupt Misra, Ajay Shriram and Dr Aniruddha B Pandit received the Lifetime Achievement Award. ICC Acharya PC Ray Award for development of indigenous technology went to Galaxy Surfactants. Jubilant Pharmova received the ICC Award For Excellence In Process Design & Engineering. ICC Award For Excellence In Management Of Health & Safety: Category I was awarded to Lanxess India, Jhagadia. ICC Certificate Of Merit For Excellence In Management Of Health & Safety: Category I was received by Rashtriya Chemicals & Fertilizers, Thal unit and Reliance Industries, Jamnagar. ICC Certificate Of Merit For Excellence In Management Of Health & Safety: Category II went to Clariant Chemicals India, Cuddalore and ICC Award For Excellence In Management Of Health & Safety: Category II was bagged by Indian Oil-Tanking, Chhattisgarh. ]]> https://biospectrumindia.com/news/22/19623/union-health-minister-inaugurates-aarogya-manthan-3-0.html https://biospectrumindia.com/news/22/19623/union-health-minister-inaugurates-aarogya-manthan-3-0.html Fri, 24 Sep 2021 14:20:00 +0530 Union Minister for Health and Family Welfare Mansukh Mandaviya inaugurated and chaired the inaugural session of Aarogya Manthan 3.0 to mark the third anniversary of Ayushman Bharat – Pradhan Mantri Jan Aarogya Yojana (AB PM-JAY) scheme for its three years successful implementation across the country, in the presence of Dr Bharati Pravin Pawar, Union Minister of State for Health and Family Welfare.    The theme of the programme was ‘Service and Excellence’. Aarogya Manthan 3.0, a four-day hybrid (physical and virtual) event commenced by observing ‘Ayushman Bharat Diwas’.    Speaking on the occasion, Mandaviya said, “AB PM-JAY has reformed the entire healthcare system of India. It gives me great happiness that the scheme has served more than 2.2 crore people in the last three years to the people residing in the remotest of the areas. The journey of the last three years of implementation of the scheme has been tremendous as it has empowered millions of citizens of India with their Right to Health.”   Mandaviya virtually interacted with AB PM-JAY beneficiaries from Jammu and Kashmir, Chhattisgarh, Andaman and Nicobar, Uttar Pradesh, Gujarat, Karnataka, Uttarakhand, Sikkim and Assam. The Union Minister of Health & Family Welfare also released the third edition of the NHA’s Annual Report 2020-2021 along with the Lessons Learnt Booklet.    During the event, the health minister gave the ‘Ayushman Utkrishta Puraskaar’ award to the best performing AB PM-JAY States/ UTs for the efficient implementation of the scheme. The awards were distributed to the States in the category of top-performing PMAM, top-performing CSC state lead, top-performing Public Hospitals, best performing states and best-performing states in gender equity.   Mandaviya also launched key initiatives — Hospital Help Desk Kiosk, Beneficiary Facilitation Agency, PMJAY Command Centre & Nudge Unit and Revamped PM-JAY technology platform, undertaken by the National Health Authority for the ease of beneficiaries while availing healthcare services under the scheme.   ]]> https://biospectrumindia.com/news/22/19615/union-health-minister-releases-post-covid-19-sequelae-modules.html https://biospectrumindia.com/news/22/19615/union-health-minister-releases-post-covid-19-sequelae-modules.html Thu, 23 Sep 2021 13:35:00 +0530 Union Minister for Health and Family Welfare Mansukh Mandaviya has released post COVID-19 sequelae modules.   The modules will help in building the capacity of the doctors, nurses, paramedics and community health workers across India to deal with the long-term effects of COVID.   Mandaviya said that proactive and comprehensive treatment of COVID-19 is required to ensure minimum side effects and no negative effects of the treatment.   He further added, “Efforts have been made by the resource persons across the country for the management of the post-covid complications to prepare post covid sequelae modules. These are very specialised modules prepared by keeping in mind various fields of healthcare professionals.”   Speaking on the occasion, Dr Bharati Pravin Pawar, Union Minister of State for Health and Family Welfare emphasised the need to tackle mental health issues and to reach the last mile. She said, “The pandemic has put an unprecedented challenge on our health and healthcare system. We need to build our capacity to tackle this challenge of mental health. If the frontline workers are equipped with proper knowledge and training, they can become a valuable resource in this fight against these post-COVID-19 challenges."         ]]> https://biospectrumindia.com/news/22/19610/gujarat-launches-portal-for-ayurveda-drug-manufacturing-license-system.html https://biospectrumindia.com/news/22/19610/gujarat-launches-portal-for-ayurveda-drug-manufacturing-license-system.html Wed, 22 Sep 2021 15:45:00 +0530 Gujarat has launched an online portal for Drug Manufacturing License System - Ayudmla for Ayurvedic Medicines. With this, Gujarat has become the first state in India to offer these facilities for Ayurvedic industry. The portal was launched during an event of GAAMA - UDAN 2021. Gujarat Ayurved Aushadh Manufacturers Association (GAAMA) recently organised 'GAAMA UDAN 2021: focusing on Difficulties, Opportunities and Scopes of Ayurvedic Industry' in Ahmedabad. Dr Hemant Koshiya, Commissioner, FDCA, Gujarat, Dr Kamleshbhai Bhatt, Joint Commissioner – Ayurveda, FDCA, Gujarat, Anand Mehta and Priyanka Shah, Technical Officer – Ayurveda, FDCA, Gujarat were present during the launch. More than 350 Ayurvedic industrialists across Gujarat participated in the event. Sharing a roadmap of the future scope activities of GAAMA, Hardik Ukani, Vice President, GAAMA and MD, Vasu Healthcare said, "The launch of the portal is the first step toward the digitalisation of the records, speedy approvals and will help the state's Ayurvedic industry to compete better in the world markets. The Ministry of Ayush has also introduced new regulations to strengthen the AYUSH System and created an online licensing portal ‘e-Aushadhi’ for AYUSH products." In the coming time, the association plans to collaborate with the different ayurvedic associations across India to make a strong representation of Ayurveda, Explore business opportunities for GAAMA members, provide technical assistance related to new regulations and guidelines etc.  ]]> https://biospectrumindia.com/news/22/19583/union-ayush-minister-inaugurates-bums-course-of-gumch-in-ganderbal-in-jk.html https://biospectrumindia.com/news/22/19583/union-ayush-minister-inaugurates-bums-course-of-gumch-in-ganderbal-in-jk.html Sat, 18 Sep 2021 10:35:00 +0530 Union Minister of Ayush and Ports, Shipping & Waterways, Sarbananda Sonowal inaugurated the first batch of BUMS (Bachelor of Unani Medicine & Surgery) course of the Government Unani Medical College & Hospital (GUMC&H) at Ganderbal in Jammu and Kashmir. The event was also graced by Lieutenant Governor of UT J&K, Manoj Sinha through virtual mode.Earlier, Sonowal took part in a plantation drive of 71 medicinal plant saplings to commemorate 71st birthday of Prime Minister Narendra Modi at the Regional Research Institute of Unani Medicine in Srinagar.Terming the inauguration of the BUMS course as a historic moment for the whole UT, the Union Minister said that institution will go a long way to promote the indigenous systems of medicine in the UT of J&K particularly the Unani System of Medicine in the Kashmir Division. He said that the Ayush Ministry is determined to provide basic healthcare services to the people of the country.  ]]> https://biospectrumindia.com/news/22/19579/govt-lays-focus-on-global-covid-19-vaccination-knowledge-management-platform.html https://biospectrumindia.com/news/22/19579/govt-lays-focus-on-global-covid-19-vaccination-knowledge-management-platform.html Fri, 17 Sep 2021 18:20:00 +0530 The Ministry of Health and Family Welfare and NITI Aayog have launched a United States Agency for International Development (USAID)-supported ‘City-to-City COVID-19 Vaccination Learning Exchange (CoVLEx) initiative to build a global COVID-19 vaccination knowledge management platform and initiate an exchange of ideas and learnings on pandemic response.   The CoVLEx platform will develop knowledge products such as an interactive web-based knowledge portal, best practices compendium, and organise virtual forums for cities and countries to learn from each other’s experiences.   The discussion topics will range from vaccine procurement, governance, digital innovations planning, and management, vaccine supply chain, communications and social mobilisation, capacity building, adverse events following immunisation, and monitoring and supervision.    In light of the COVID-19 pandemic, countries have been thrown into challenging situations concerning response and recovery, particularly those without domestic vaccine production capacities in the Global South. Despite the challenges along the way, several countries have also tried to implement innovative solutions through collaborations, technology, and private sector engagement.    As part of the initiative, 15 Indian and global cities will initially participate to engage with more cities in the future. COVID-19 vaccination strategies have the potential to be a game-changer in strengthening national routine immunisation programmes, which in turn will contribute to delivering effective primary healthcare services and accelerate progress towards achieving universal healthcare.   ]]> https://biospectrumindia.com/news/22/19569/dcgi-approves-stem-cell-based-therapy-trial-for-covid-19-pneumonia-treatment.html https://biospectrumindia.com/news/22/19569/dcgi-approves-stem-cell-based-therapy-trial-for-covid-19-pneumonia-treatment.html Thu, 16 Sep 2021 14:10:00 +0530 LifeCell's latest therapy called Mesocel has received approval for a clinical trial on COVID-19 pneumonia and acute respiratory distress from the Biological Division of the Drug Controller General of India (DCGI). Derived from Mesenchymal Stem Cells (MSCs) obtained from donated umbilical cord tissue, Mesocel is set to treat patients suffering from life-threatening COVID-19 pneumonia and acute respiratory distress. The clinical trial, to be conducted in two phases, will evaluate the safety and efficacy of Mesocel for the treatment of patients with moderate to severe COVID-19. The therapy involves 100 million + expanded MSCs obtained from donated umbilical cord tissue and are intravenously infused into patients in two intravenous doses. The therapy can be undertaken without the need for immune matching between donor and patient.LifeCell has set up a manufacturing facility at its Chennai campus that will further bolster its biologics manufacturing capabilities. Equipped with multiple bioreactors of different sizes, the facility ensures an uninterrupted supply of MSCs for timely and affordable treatment by using the bio-reactors to expand the cells in a sterile environment, thereby providing significant advantages from a cost and quality-control perspective. ]]> https://biospectrumindia.com/news/22/19565/india-east-asian-partners-collaboration-to-benefit-health-infra-amidst-covid-19-anupriya-patel.html https://biospectrumindia.com/news/22/19565/india-east-asian-partners-collaboration-to-benefit-health-infra-amidst-covid-19-anupriya-patel.html Thu, 16 Sep 2021 11:00:00 +0530 The T9th EAS-EMM (East Asia Summit-Economic Ministers’ Meeting) was recently held virtually. Addressing the meeting, Anupriya Patel, Minister of State for Commerce and Industry said the World Trade Organisation (WTO) had observed that the strong monetary and fiscal policies introduced by many governments in response to pandemics helped to sustain the global demand and trade. Considering the encouraging trend, WTO had also revised its projection for global trade volume growth in 2021 to 8 per cent compared to the 7 per cent earlier.   “Various immediate supportive actions taken by India, including the milestones reached in vaccination helped us to manage the pandemic crisis. We have learnt lessons, adapted our approach and fine-tuned our systems as we went along,” she said.   She said that the world needs meaningful partnerships, sharing of advanced technologies, collaboration in vaccine and pharmaceutical production, capacity building and transparency in health information. India is willing to collaborate with East Asian partners in the production of generic drugs and medical technologies used for the treatment of COVID-19 patients, as also in the area of vaccines production. 70 per cent of the global vaccines are produced in India and our capacity to produce quality medicines and vaccines at affordable prices are globally recognised.   In an interconnected and globalised world, no one is safe until everyone is safe; India looks forward to an early outcome on the TRIPS Waiver proposal for vaccines, therapeutics and diagnostics. Shared prosperity is impossible without shared commitment.    She stated that India endorses the concept of working towards ensuring a trustworthy and reliable supply chain. “I have keenly listened to Economic Research Institute for ASEAN and East Asia (ERIA) discussion on the value chains and post-pandemic recovery in East Asia. Regional and global value chains are a core element of the economic strength of the EAS region. It is heartening to know from ERIA’s research work that the pandemic so far did not disrupt the production system and trade patterns in East Asia Region and the region maintained its importance in the World Trade Network,” the MoS said.    While acknowledging the progress achieved so far, India would like to emphasise the need to further strengthening the EAS work processes for appropriate coordinated responses to the pandemic, learning from each other’s best practices.    Acting East is now a central element in India's Indo-Pacific vision. India wants to see a strong, unified and prosperous ASEAN playing a central role in the emerging dynamic of the Indo-Pacific. We see a great deal of convergence between India's vision for the Indo-pacific and the ASEAN Outlook on Indo-Pacific.   She congratulated and thanked Brunei for its efficient role as the Chair of ASEAN. She also commended the ASEAN Secretariat for putting together a useful analysis of regional and global economic development in the discussion papers. She concluded by reiterating that India's support in collective actions of the EAS Forum aimed at mitigating the economic impact of the pandemic and strengthening regional economic architecture.     ]]> https://biospectrumindia.com/news/22/19560/ayush-ministry-enhances-export-potential-of-traditional-medicines.html https://biospectrumindia.com/news/22/19560/ayush-ministry-enhances-export-potential-of-traditional-medicines.html Wed, 15 Sep 2021 13:20:00 +0530 Ministry of Ayush has paved the way for strengthening the quality of Ayurvedic and other Indian Traditional Medicine products globally and also enhance export potential, especially to the US Market.   This has been achieved by the signing of a Memorandum of Understanding (MoU) between the Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) and American Herbal Pharmacopoeia, USA.   The MoU was signed virtually. Ministry of Ayush has entered this MoU with the specific purpose of strengthening, promoting, and developing standards in the field of Ayurveda and other Indian traditional systems of medicine between the two countries based on equality and mutual benefit.   The collaboration of efforts will go a long way in enhancing the export potential of the ASU&H (Ayurveda, Siddha, Unani and Homeopathy) drugs. Under this MoU, there will be the constitution of a Joint Committee to develop the action plan along with timelines for the development of monographs and other activities for cooperation in the field of traditional medicine.   ]]> https://biospectrumindia.com/news/22/19543/dr-bharati-pravin-pawar-inaugurates-digital-population-clock-at-institute-for-economic-growth.html https://biospectrumindia.com/news/22/19543/dr-bharati-pravin-pawar-inaugurates-digital-population-clock-at-institute-for-economic-growth.html Sat, 11 Sep 2021 20:20:00 +0530 Union Minister of State for Health and Family Welfare, Dr Bharati Pravin Pawar inaugurated and presided over the seminar on Population, Human Capital and Sustainable Development (healthy people – healthy future), in Delhi. She also inaugurated a digital population clock at the Institute for Economic Growth nestled inside the University of Delhi. The Union Minister launched a book titled 'Infant and Child Mortality In Assam – Demographic and Socio-Economic Interrelations' written by Dr Dipanjali Haloi and Dr Suresh Sharma and an HMIS Brochure / Ready Reckoner at the event.    Dr Pawar spoke on the need to have greater discussion and awareness on the population as India is poised to become the most populous country by 2027 according to estimates. She underlined that the Ministry of Health and Family Welfare is committed to strengthening the health infrastructure across the country and fulfil the Prime Minister’s Vision of 'Health for All.'   Dr Pawar observed, “Population policy should intend to stabilise population and it requires both macro and micro approach. Government is ensuring that everyone gets clean fuel, house, clean water and health care.” Enumerating how population estimation is critical in the distribution and access to public goods, she brought to light the critical role Population Research Centers (PRCs) can play in researching contemporary issues.   The Health Minister appreciated the wide range of studies conducted by the PRCs which help in policy formulation and evaluation of schemes. She noted that PRCs have visited all the Health and Wellness centres in India. She underlined how Population Research Centres can help the Ministry of Health and Family Welfare in monitoring various flagship programmes of the Government of India like Lakshya, Kayakalp and Ayushman Bharat.   Dr Pawar emphasised that the population clock will be beneficial to everyone as it provides an interactive and quick overview of the entire nation’s population. She said that the population clock will provide minute by minute estimate of India’s population. It will also help in capturing data regarding total fertility rate, infant mortality rate and maternal mortality rate. She hoped that this clock will be able to create awareness in young generations apart from its importance in research.   Sandhya Krishnamurthy, DG (Stats), DK Ojha, DDG (Stats.) and other senior officials of the Ministry of Health and Family Welfare were also present.  ]]> https://biospectrumindia.com/news/22/19540/cil-signs-mou-with-assam-health-dept-to-strengthen-infrastructure.html https://biospectrumindia.com/news/22/19540/cil-signs-mou-with-assam-health-dept-to-strengthen-infrastructure.html Fri, 10 Sep 2021 14:55:00 +0530 Coal India Ltd (CIL), under the Ministry of Coal, has signed an MoU with the Department of Health & Family Welfare, Government of Assam for strengthening the health infrastructure at the Silchar Medical College & Hospital, Silchar, the only Medical College and Hospital in Barak Valley Region, Assam.   In this new CSR initiative, CIL will contribute Rs 5 crores towards setting up an ICU facility and medical gas pipeline in the Silchar Medical College & Hospital which will benefit over 40 lakh people of the state.   The MoU was signed in the presence of Dr Himanta Biswa Sarma, Chief Minister of Assam and Health Minister Keshab Mahanta.    CIL and its subsidiaries have undertaken several high-investment, high-impact projects to help improve medical facilities across the country. Notable projects being the Medical College cum Hospital at Talcher in Odisha for Rs 492 crores, ‘Premashraya’, a home for children and their families seeking cancer treatment at Kolkata for Rs 41 crores, Support for Bone Marrow transplants of children suffering from Thalassemia for Rs 40 crores and a Cardiac Care Centre at Jharsuguda, Odisha for Rs 75 crores. ]]> https://biospectrumindia.com/news/22/19521/india-australia-to-appoint-academic-chair-in-ayurveda.html https://biospectrumindia.com/news/22/19521/india-australia-to-appoint-academic-chair-in-ayurveda.html Tue, 07 Sep 2021 17:00:00 +0530 All India Institute of Ayurveda under Ministry of Ayush has signed a MoU in coordination with NICM Western Sydney University Australia, in virtual mode, to appoint an Academic Chair in Ayurveda. The MoU was signed by Professor Tanuja Nesari, Director, All India Institute of Ayurveda, Ministry of Ayush and Vice-Chancellor and President, Western Sydney University, Australia, Professor Barney Glover. The new Academic Chair will undertake academic and collaborative research activities in Ayurveda, including herbal medicine and yoga, as well as   design academic standards and short-term/medium-term courses and educational guidelines. This Chair will also conduct workshops/seminars/conferences on Ayurveda, advocate the safe and effective use of Ayurveda Systems in Australia, identify in academic and research programs on Ayurveda their strengths and gaps, provide tutorials to students, including the promotion of research activities and innovations in Ayurveda in India. This Ayurveda Academic Chair will be based at Western Sydney University’s NICM Health Research Institute, with tenure for a period of three years. The appointment of the chair is jointly funded by the Ministry of Ayush and Western Sydney University and anticipated to commence early in 2022. ]]> https://biospectrumindia.com/news/22/19510/indian-railways-rolls-out-hmis-across-129-railway-hospitals-and-586-health-units.html https://biospectrumindia.com/news/22/19510/indian-railways-rolls-out-hmis-across-129-railway-hospitals-and-586-health-units.html Mon, 06 Sep 2021 11:55:00 +0530 RailTel- a miniratna PSU of Ministry of Railways and C-DAC- A unit (e shushrut) under Ministry of Electronics & Information Technology, have been entrusted with the task of implementing pan India Hospital Management Information System (HMIS) at 129 railway hospitals and 586 health units to bring the entire railway health system on a single architecture to provide faster, seamless and hassle-free healthcare.    Out of a total of 11,76,300 employees of Railways, registered employee beneficiaries are 11,24,058. Total HMIS employee cards generated are 10,33,143. Card generated is persons who have got their UMID card made. Out of the total 16,52,082 pensioners of Railways, registered pensioners beneficiaries are 4,83,592. Total HMIS pensioners beneficiaries cards generated are 3,75,440. Employees have an average of three to four dependent and pensioners have two to three dependents.   HMIS has already been deployed over 156 health facilities across Indian Railways. Further accelerated deployment over balance health facilities will be done in 2021.   HMIS solution is going to cover the entire gamut of clinical care as well as hospital administration with around 20 modules that are relevant to Railway hospitals. The modules cover both cores as well as ancillary requirements of hospital management like areas of OPD, IPD, Labs, OT, blood bank, pharmacy, referrals, medical examinations and reimbursement of medical claims etc.   A mobile app has also been developed to empower the medical beneficiaries that enable the patients to access their Electronic Medical Record (EMR) from anywhere. Features like teleconsultation, lab report access, Medicines disbursed to patients etc have also been provided through this app. Feature of self-registration is also available on this App.   The system is fully integrable with the National Digital health Mission program of the Ministry of Health and Family Welfare. The HMIS has been synchronised with various other digital initiatives of the Indian Railway like Unique Medical ID (UMID), IPASS and ARPAN etc and is capable of further such integrations as per need.   Digitisation of health data which is accessible through unique medical ID (UMID) of Railway healthcare beneficiaries is going to make the healthcare services hassle-free and transparent. A patient can take OPD appointments by scanning the QR code through the HMIS app. This will bring improvement in patient care and patient services to approximately 10 million Railway health beneficiaries. ]]> https://biospectrumindia.com/news/22/19504/ayush-minister-launches-campaign-to-distribute-prophylactic-medicines-at-nia-jaipur.html https://biospectrumindia.com/news/22/19504/ayush-minister-launches-campaign-to-distribute-prophylactic-medicines-at-nia-jaipur.html Fri, 03 Sep 2021 18:30:00 +0530 Minister of Ayush and Port, Shipping & Waterways Sarbananda Sonowal launched a campaign of distributing Ayush prophylactic medicines and written guidelines on diet and lifestyle at National Institute of Ayurveda (NIA), Jaipur as part of ‘Azadi Ka Amrit Mahotsav’. The campaign will see the distribution of Sanshamani Vati, which is also known as Guduchi or Giloy Ghan Vati, and Ashwagandha Ghan Vati to 75 lakh people across the country, with a special focus on the geriatric (people of 60 years and above age) population and the front-line workers in the next one year.   Addressing the gathering, Sonowal emphasised the importance of spreading the message of Ayurveda across the country so that everyone can adopt it as a part of their lifestyle and achieve the aim of a healthy nation.   The Union Minister also urged the entire Ayurveda fraternity to join hands and work together so India could lead the world through its ancient wisdom of Ayurveda and Yoga.   The Union Minister also visited the NIA hospital where he interacted with students and the hospital staff. He was particularly impressed by the hygiene and cleanliness at the hospital. The kit of Ayurveda prophylactic medicines and the guidelines have been prepared by the Central Council for Research in Ayurvedic Medicines (CCRAS).  ]]> https://biospectrumindia.com/news/22/19494/instead-of-ministry-wise-approvals-we-should-go-for-theme-based-projects-st-minister.html https://biospectrumindia.com/news/22/19494/instead-of-ministry-wise-approvals-we-should-go-for-theme-based-projects-st-minister.html Thu, 02 Sep 2021 17:00:00 +0530 Government will collaborate with stakeholders in developing medical technology. This was stated by the Union Minister of State (Independent Charge) Science & Technology (S&T); Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr Jitendra Singh in his virtual address to the 13th CII Global MedTech Summit on the “Sunrise Medical Devices Sector in India” on 2 Sept. Dr Jitendra Singh added, "Most medical technologies are not indigenous and we are still dependent on as much as 85% imported technologies. One reason being the healthcare sector has never been given priority here in India, neither social nor cultural, owing to legacy issues besides economic constraints." He further said, Earlier, entrepreneurs were reluctant to invest as there were multiple window clearances, sometimes 70 even in small scale sector. COVID-19 has served to give a kneejerk to indigenous technologies such as CSIR in manufacturing ventilators, vaccine production by DBT, ISRO in Liquid Oxygen. Instead of Ministry/Department wise approvals, we should go for theme based projects involving the private sector. Indigenous medical technologies will help reduce dependence on imports and for this the government, private sector, corporates and scientists, all will have to come together and pool their resources." India’s Medical Technology sector was worth $11 billion in 2020. A CII study estimates, this will grow up to $50 billion by 2025. ]]> https://biospectrumindia.com/news/22/19493/nha-to-conduct-open-house-discussion-on-ndhm-on-sept-6.html https://biospectrumindia.com/news/22/19493/nha-to-conduct-open-house-discussion-on-ndhm-on-sept-6.html Thu, 02 Sep 2021 16:40:00 +0530 The National Health Authority (NHA), will hold an Open House discussion on September 6, 2021, from 3 pm to 5m, to deliberate the development of different digital public goods under the National Digital Health Mission (NDHM).   The Open House, to be held live through a digital mode and will facilitate a participative and transparent discussion between NHA and stakeholders. Earlier, NHA published three consultation papers on various NDHM building blocks - the Health Facility Registry (HFR), Healthcare Professionals Registry (HPR), and Unified Health Interface (UHI), inviting stakeholders’ comments, feedback and suggestions.   All the comments received on the three consultation papers have been published on the NDHM website for public viewing. The Open House will enable a conversation on the key questions raised in the papers and NHA requests all stakeholders to actively participate in the discussion.    The Open House will not only enable participants to lend their voice to the development of the digital health ecosystem in the country but also facilitate conversations between the public and the government.      ]]> https://biospectrumindia.com/news/22/19481/improvement-in-health-infra-will-lead-to-confidence-in-economic-revival-sitharaman.html https://biospectrumindia.com/news/22/19481/improvement-in-health-infra-will-lead-to-confidence-in-economic-revival-sitharaman.html Wed, 01 Sep 2021 11:40:00 +0530 Union Minister for Finance & Corporate Affairs Nirmala Sitharaman said that overall improvement of health infrastructure will help build the confidence of the people in the infrastructure and also help in the revival of the economy. The finance minister said this while addressing the webinar on 'Building Healthcare Infrastructure for New India' in New Delhi. Dr Bhagwat Kisanrao Karad, Minister of State for Finance, participated in the webinar.   Sitharaman stated that the country must address not only the short-term challenges but also ensure the resilience of our economy and infrastructure development that are the key to achieving these twin objectives.    The finance minister said it is very encouraging to have industry stakeholders be part of a discussion on the Loan Guarantee Scheme for COVID-affected Sectors (LGSCAS) that the government launched with great trust in the industry.   The Finance Minister emphasised that the most important support to healthcare infrastructure is to ramp up capacities, technology, better facilities and above all ramp up trained manpower for optimally utilising the healthcare infrastructure.   Earlier in the webinar, Debashish Panda, Secretary, Department of Financial Services, gave an outline of the Loan Guarantee Scheme for COVID-affected Sectors (LGSCAS) scheme to all the participants. VK Paul, Member, NITI Aayog emphasised the need and equitable distribution of healthcare facilities so that access to healthcare is easily available in Tier-II, Tier-III and Tier-IV cities.   Expressing his happiness on LGSCAS, Rajesh Bhushan, Secretary, Ministry of Health & Family Welfare, said that it aims at non-metro cities which require strengthening of healthcare services and facilities. The LGSCAS will become a path-breaking scheme as it can collaborate and it can work in conjunction with other ongoing interventions in the healthcare sector.   Talking about the LGSCAS, CS Setty, MD, SBI, said that it is the first-of-its-kind of scheme where a guarantee is provided for healthcare infrastructure. Setty gave a well-informed presentation on healthcare infrastructure and government-guaranteed schemes and informed all the participants that they have devised a fairly simple process of applying and processing documents related to LGSCAS.   As part of the Open House discussion, Dr Harsh Mahajan, President, Healthcare Federation of India; Dr Rajib Nath, Forum Coordinator, AiMeD; Ayanabh Debgupta, FICCI, and Veena Kohli, President, Association of Diagnostics Manufacturers of India, also participated. During the webinar, over 100 stakeholders from the healthcare industry and banks highlighted the importance of strengthening the Indian healthcare ecosystem specifically targeting underserved areas. ]]> https://biospectrumindia.com/news/22/19473/ministry-of-labour-and-employment-initiates-process-to-set-up-esic-hospital-at-dholera-sir.html https://biospectrumindia.com/news/22/19473/ministry-of-labour-and-employment-initiates-process-to-set-up-esic-hospital-at-dholera-sir.html Tue, 31 Aug 2021 15:25:00 +0530 Ministry of Labour and Employment, Government of India has accepted and initiated the proposal submitted by Dholera Industrial City Development Limited (DICDL) for setting up an ESIC hospital, as Dholera Special Investment Region (DSIR) has already identified a land parcel for a 200-bed hospital in the activation area. As of now, 22.54 sq km is being developed in phase 1 of the Activation area out of 920 sq km. It will impact the development at the DSIR, since Dholera is experiencing immigration in the form of skilled and unskilled labourers for the ongoing construction activities in and around the activation area.   Dholera SIR, which caters to more than 4500 labourers and a request to the Ministry of Labour and Employment, was made for setting up a hospital to deliver high-quality healthcare for its workers.    Hareet Shukla, MD, DICDL, said, "We are pleased to announce that the Ministry has approved our request and dialogue has been initiated with the officials from State ESIC for setting up an ESI Hospital Dholera SIR. This would greatly benefit the workers and, in turn, will be a great push for the region's development. The healthcare facility will serve not only the existing employees and workers but also the futuristic development due to existing and proposed connectivity projects."   ]]> https://biospectrumindia.com/news/22/19452/govt-provides-support-worth-rs-80-cr-to-boost-ayurveda-in-north-east.html https://biospectrumindia.com/news/22/19452/govt-provides-support-worth-rs-80-cr-to-boost-ayurveda-in-north-east.html Sun, 29 Aug 2021 08:05:00 +0530 In a major boost to the initiatives to promote traditional medicinal practices in the Northeast, Sarbananda Sonowal, Union Minister of Ports, Shipping & Waterways and AYUSH, has announced a slew of major initiatives at a conference of Ayush and Health Ministers of all the North Eastern States held on 28 August. The conference was organised by the Ministry of AYUSH to discuss how the Ayush System of Medicines can be efficiently mainstreamed and can become more popular in the Northeastern states. The Union Minister Sonowal announced that in order to boost the education and training of Ayush medicinal experts, financial provision of Rs 70 crore, under National Ayush Mission (NAM) support, is to be provided for establishment of a new Ayurvedic College at Dudhnoi in Goalpara, Assam. The Ministry of AYUSH has also decided to upgrade the Government Ayurvedic College in Guwahati and develop it as a Centre of Excellence and a sum of Rs 10 crore as financial grant is to be provided in this regard, he added. Sonowal also announced that as many as 1000 new Health & Wellness Centres (HWC), as part of the National Ayush Mission (NAM) Scheme, will be opened in the NE states for growth and development of Ayush systems. With an aim to boost the popularity of traditional medicines provided by Ayush, the minister also announced setting up of 100 Ayush dispensaries under NAM in the north east region. Informing that a facilitation Centre for Semi Processing of raw material is going to be opened up in NE the Union Minister said that along with this, it is also envisaged to set up Regional Raw Drug Repository (RRDR) in NE states in collaboration with National Institute of Bio-resources and sustainable development in Imphal, Manipur under Department of Biotechnology. ]]> https://biospectrumindia.com/news/22/19442/union-health-minister-takes-charge-as-chairperson-of-stop-tb-partnership-board.html https://biospectrumindia.com/news/22/19442/union-health-minister-takes-charge-as-chairperson-of-stop-tb-partnership-board.html Thu, 26 Aug 2021 17:00:00 +0530 Union Minister for Health and Family Welfare Mansukh Mandaviya has taken charge as the Chairperson of Stop TB Partnership Board. The minister will hold the responsibility with immediate effect until 2024. He will lead the efforts of the Stop TB Partnership Secretariat, partners, and the TB community at large, towards reaching the UN TB targets by 2022, a milestone moment in the effort to end TB by 2030.   Mandaviya said on the occasion, "I am honoured to take the Chair of the Stop TB Partnership Board and thus secure the continuation of the commitment to global efforts to end this devastating disease worldwide by 2030. I look forward to working with the Stop TB Partnership Board and Secretariat in leading the efforts to end TB.”    He also expressed his gratitude to the outgoing Chair of Stop TB Board, former Union Minister of Health and Family Welfare Dr Harsh Vardhan and appreciated the initiatives taken by the partnership under his guidance.   The Stop TB Partnership also welcomed the incoming Board Vice-Chair Austin Arinze Obiefuna, Executive Director of Afro Global Alliance - who was earlier the Board Member representing the biggest constituency on the Stop TB Partnership Board, Developing Country NGOs. He will take over as the Board Vice-Chair from January 1, 2022, for three years.   Dr Lucica Ditiu, Executive Director of the Stop TB Partnership acknowledging India’s efforts to eliminate TB said that the new leadership’s experience and passion will be instrumental in taking the organisation forward in the next three years. ]]> https://biospectrumindia.com/news/22/19437/govt-to-offer-special-incentives-to-75-startups-in-telemedicine-ai-and-digital-health.html https://biospectrumindia.com/news/22/19437/govt-to-offer-special-incentives-to-75-startups-in-telemedicine-ai-and-digital-health.html Wed, 25 Aug 2021 19:25:00 +0530 The government will soon launch a special incentives scheme to support 75 start-ups in areas of telemedicine, digital health and artificial intelligence (AI) to coincide with the ‘Azadi ka Amrit Mahotsav’ being celebrated from 15th August this year.    The scheme will be launched by the Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Enterprise under the Department of Biotechnology, Government of India. In addition, an e-office of BIRAC has also been launched.     BIRAC has lent funding support of over Rs 2,128 crores to more than 1,500 Startups, Enterprises and SMEs. From supporting less than 50 Biotechnology Startups in 2012 with Innovative Funding of less than Rs 10 crore, the BIRAC is now funding over 5,000 BT Startups with over 2,500 crore. By the year 2024, the BIRAC targets to support more than 10,000 BT Startups.   BIRAC has an in-house BIRAC 3i portal to its credit, where all the applications and proposals are submitted online. This portal was launched in February 2010 and is a dynamic, robust, scalable application for Science and Innovative Research Fund Management wherein various stakeholders like companies, institutes and individuals submit their proposals online.   ]]> https://biospectrumindia.com/news/22/19425/mps-chief-minister-meets-union-health-min-for-covid-vaccines.html https://biospectrumindia.com/news/22/19425/mps-chief-minister-meets-union-health-min-for-covid-vaccines.html Tue, 24 Aug 2021 14:50:00 +0530 The Chief Minister of Madhya Pradesh, Shivraj Singh Chouhan, met the Union Minister for Health and Family Welfare and Chemicals and Fertilizers, Mansukh L Mandaviya to discuss the vaccination campaign being run in the state. Chouhan informed that under the vaccination campaign being run across the country, the government is committed to administering both doses of the vaccine to 100 per cent of citizens of the state. In this sequence, the second phase of the vaccination campaign is being organised on August 25 and 26. Under the campaign, a target has been set to vaccinate a total of 35 lakh citizens in two days. Chouhan urged the Union Minister that to make the said campaign successful, the state should get an additional dose of 11 lakh vaccines by August 24 so that the campaign can be made successful. The Union Minister assured the Chief Minister that 11 lakh vaccine doses would be provided to the State Government by the Center by August 24.   ]]> https://biospectrumindia.com/news/22/19415/union-power-minister-flags-off-dedicated-medical-van-for-cancer-detection-camp-in-bihar.html https://biospectrumindia.com/news/22/19415/union-power-minister-flags-off-dedicated-medical-van-for-cancer-detection-camp-in-bihar.html Sat, 21 Aug 2021 19:30:00 +0530 Union Minister for Power, New & Renewable Energy RK Singh during his visit to Nabinagar Power Generating Company Ltd (NPGC) premises, a wholly-owned subsidiary of NTPC recently, dedicated various CSR works carried out by NTPC & NPGC to the tune of Rs 11.32 crores.    Singh inaugurated PHC at Meh – Aurangabad and distributed disability aid items in association with ALIMCO at Barh. He flagged off a dedicated medical van for cancer detection camp to be organised in four districts of Bihar and distribution of aids and appliances to the differently-abled residing in the vicinity of NTPC Barh via online/offline mode in a function. ]]> https://biospectrumindia.com/news/22/19414/zydus-receives-eua-for-worlds-first-plasmid-dna-vaccine-for-covid-19.html https://biospectrumindia.com/news/22/19414/zydus-receives-eua-for-worlds-first-plasmid-dna-vaccine-for-covid-19.html Fri, 20 Aug 2021 13:00:00 +0530 Ahmedabad-based pharma firm Zydus Cadila has announced that the company has received the Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D the world’s first Plasmid DNA Vaccine for COVID-19. ZyCoV-D is a three dose vaccine which will be administered first on day zero, day 28th and then on the 56th day. With this approval, India now has its first COVID-19 vaccine for the adolescents in the 12-18 age group, besides the adult population. ZyCoV-D, is a needle-free vaccine administered using The PharmaJet® a needle free applicator, which ensures painless intradermal vaccine delivery. This is for the first time that a technologically advanced vaccine has been successfully developed on the Plasmid DNA platform for human use. The platform because of its rapid plug and play technology can be easily adapted to deal with mutations in the virus, such as those already occurring. The company plans to manufacture 10-12 crore doses of ZyCoV-D annually. The company also plans to seek approval for the two dose regimen of the vaccine. The main advantage of DNA vaccines is their ability to stimulate both the humoral and cellular arms of the adaptive immune system. They are a valuable form of antigen-specific immunotherapy, as they are safe, stable and can be easily produced. ]]> https://biospectrumindia.com/news/22/19398/cabinet-approves-icmrs-recent-mous-on-diagnostics-and-amr-research.html https://biospectrumindia.com/news/22/19398/cabinet-approves-icmrs-recent-mous-on-diagnostics-and-amr-research.html Wed, 18 Aug 2021 12:00:00 +0530 The Union Cabinet, chaired by Prime Minister Narendra Modi, was apprised of Memorandum of Understanding (MoU) signed between the Indian Council of Medical Research (ICMR), India and the GARDP Foundation on Antimicrobial Resistance (AMR) Research and Innovation to strengthen the relations within the framework of the international scientific and technological collaboration and to promote cooperation in fields of mutual interest. The MoU was signed by India in March’2021. The Cabinet has also approved the MoU signed between the ICMR and Foundation for Innovative New Diagnostics (FIND), Switzerland. The MoU has been signed in February’2021 by India. The ICMR-GARDP Collaborations will include establishing a strategy and modalities for financial and in-kind contributions by both Parties to ensure the success of the joint objectives. Funding may be provided directly to the other Party or to the third parties engaged in Projects. All financial and in-kind contributions will be subject of separate legally binding agreements. Further, ICMR is committed to make available funding up to $100,000 while FIND will make available funds up to $ 400,000 to local partners and researchers identified through Request for proposal (RFP). ]]> https://biospectrumindia.com/news/22/19385/govt-approves-one-more-lab-for-batch-testing-of-covid-19-vaccines.html https://biospectrumindia.com/news/22/19385/govt-approves-one-more-lab-for-batch-testing-of-covid-19-vaccines.html Mon, 16 Aug 2021 13:00:00 +0530 The Ministry of Health and Family Welfare has authorised National Institute of Animal Biotechnology (NIAB), Hyderabad as Central Drug Laboratory (CDL) for testing and lot release of COVID-19 vaccines. The Department of Biotechnology (DBT) had proposed two laboratories namely NIAB and National Centre for Cell Sciences (NCCS), Pune for this purpose. Funds from Prime Minister Cares Fund Trust (PM-CARES) have been allotted for upgradation of these two laboratories. NCCS, Pune has already been notified as a CDL laboratory by MoHFW. The notification of these two laboratories as CDL laboratories is intended to improve vaccine production and will ultimately strengthen the vaccination campaign.  ]]> https://biospectrumindia.com/news/22/19369/iil-receives-cdsco-loan-licence-to-supply-covaxin.html https://biospectrumindia.com/news/22/19369/iil-receives-cdsco-loan-licence-to-supply-covaxin.html Fri, 13 Aug 2021 20:55:00 +0530 Department of Biotechnology and BIRAC under the Mission Covid Suraksha announced by the Government of India, under Atmanirbhar Bharat 3.0 to accelerate the development and production of Indigenous COVID Vaccines, have launched a project to augment production capacities of Covaxin.   Indian Immunologicals Limited (IIL), Hyderabad, is the first site under this project to receive from CDSCO, a loan license for supplying Covaxin Drug Substance produced at its repurposed facility to Bharat Biotech. Indian Immunologicals will supply the first lot of commercial Covaxin Drug Substance to Bharat Biotech. The facility will produce two to three million doses per month initially, and another four to five million doses from its new facility at Karkapatla, in the next few weeks.   Speaking on this achievement Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, ‘’The government has worked relentlessly to provide all possible support for ramping up Covaxin production in the country and speed up Covaxin inoculation drive. The loan license agreement by CDSCO for Indian Immunologicals to produce Covaxin Drug Substance is a major milestone, achieved in a very short period. The DBT-BIRAC support under Mission Covid Suraksha aims to meet the Covid-19 vaccine requirement of our country. I congratulate the team for the efforts put in for this achievement.”   “IIL is also working on another COVID -19 vaccine and the animal trials are underway currently and is expected to come out by next year for human vaccination," said Dr K Anand Kumar, MD, IIL.   ]]> https://biospectrumindia.com/news/22/19368/indias-first-nasal-vaccine-for-covid-19-receives-nod-for-ph-2-3-trial.html https://biospectrumindia.com/news/22/19368/indias-first-nasal-vaccine-for-covid-19-receives-nod-for-ph-2-3-trial.html Fri, 13 Aug 2021 17:00:00 +0530 Bharat Biotech's intranasal vaccine is the first nasal vaccine that has received the regulatory approval for Phase 2/3 trials. This is the first of its kind COVID-19 jab to undergo human clinical trials in India. BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. Bharat Biotech has in-licensed technology from Washington University in St Louis, USA.  Phase 1 Clinical trial has been completed in age groups ranging ≥18 to ≤60 years. The Company reports that the doses of the vaccine administered to healthy volunteers in the Phase I clinical trial, has been well tolerated. No serious adverse events reported. Previously, the vaccine was found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit high level of neutralizing antibodies in animal studies.  ]]> https://biospectrumindia.com/news/22/19353/rajya-sabha-clears-national-commission-for-indian-system-of-medicine-bill-2021.html https://biospectrumindia.com/news/22/19353/rajya-sabha-clears-national-commission-for-indian-system-of-medicine-bill-2021.html Thu, 12 Aug 2021 12:40:00 +0530 The Rajyasabha has passed the National Commission for Homoeopathy (Amendment) Bill, 2021 and the National Commission for Indian System of Medicine (Amendment) Bill, 2021 on August 11, 2021. The two bills were cleared by the Lok Sabha on August 10, 2021. Moved by Sarbananda Sonowal, Minister of Ayush, the National Commission for Indian System of Medicine (Amendment) Bill, 2021, seeks to save the actions done, decisions made, liability incurred by the Board of Governors constituted as per the provisions of the Indian Medicine Central Council (Amendment) Ordinance, 2021 till the constitution of National Commission under National Commission for Indian System of Medicine Act, 2020. The Rajya Sabha also passed the National Commission for Homoeopathy (Amendment) Bill, 2021 moved by the Minister which seeks to save the actions done, decisions made, liability incurred by the Board of Governors constituted as per the provisions of the Homoeopathy Central Council (Amendment) Ordinance, 2021 till the constitution of National Commission under National Commission for Homoeopathy Act, 2020. The two bills will now be sent to the President for his assent. ]]> https://biospectrumindia.com/news/22/19322/icmr-validates-6-self-testing-kits-for-covid-19.html https://biospectrumindia.com/news/22/19322/icmr-validates-6-self-testing-kits-for-covid-19.html Mon, 09 Aug 2021 12:40:00 +0530 Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health, and Family Welfare, Government of India has recently issued a notification on the validation of COVID-19 Home Testing using Rapid Antigen (Ag) Tests (RATs). The US-FDA approved antigen-based COVID-19 Home/Self tests are exempted from ICMR validation.To date,  six Rapid Ag-based Home / Self Test Kits have been validated. These are Mylab Discovery Solutions, Pune for CoviSelfTM (PathoCatch) COVID-19 OTC Antigen LF device; Abbott Rapid Diagnostics Division, Chicago (Alere Medical, Gurugram) for PanBio COVID-19 Antigen Rapid Test Device and Meril Diagnostics, Vapi (Gujarat), for CoviFind COVID-19 Rapid Ag Self Test.The other validated Rapid Ag-based Home/self Test Kits kits but not yet approved by ICMR are as follows: Trivitron Healthcare for MyCoviTest Self Test Kit, Oscar Medicare, Delhi for OSKIT Corona Ag Home Test and Oscar Medicare, Haridwar (Uttarakhand) for OSKIT Corona Ag Home Test. ]]> https://biospectrumindia.com/news/22/19320/jj-covid-19-vaccine-receives-eu-approval-in-india.html https://biospectrumindia.com/news/22/19320/jj-covid-19-vaccine-receives-eu-approval-in-india.html Sun, 08 Aug 2021 00:00:00 +0530 American firm Johnson & Johnson (J&J) has received approval for Emergency Use (EU) for its single-shot COVID-19 vaccine candidate in India. "India has expanded its vaccine basket. Now India has 5 Emergency Use Authorised (EUA) vaccines", tweeted Mansukh Mandviya, Union Health Minister, Government of India. India has so far administered Covishield, Covaxin, and Sputnik V vaccines. Mumbai-based pharmaceutical company Cipla has also been granted approval to import the Moderna vaccine. Hyderabad-based Biological E will be an important part of Johnson and Johnson's global supply chain network, for supplying its COVID-19 vaccine.   ]]> https://biospectrumindia.com/news/22/19283/india-sweden-to-launch-new-joint-call-on-health-science.html https://biospectrumindia.com/news/22/19283/india-sweden-to-launch-new-joint-call-on-health-science.html Mon, 02 Aug 2021 20:00:00 +0530 Union Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr Jitendra Singh called for Global Scientific Collaboration for bringing “Ease of Living” for common man, on 2 August. A Swedish Delegation led by Ambassador KlasMolin called on the Union Minister to discuss and review bilateral cooperation in Science and Technology and Innovation. The Principal Scientific Adviser to the Government of India Professor K. VijayRaghavan, Secretary, DST, Professor Ashutosh Sharma, Secretary DBT, Smt. RenuSwarup, DG, CSIR and Secretary, DSIR, Shri Shekhar Mande and other senior officers of the Ministry took part in the meeting. Dr Jitendra Singh said, both the Governments proposed to launch a new joint call on Circular economy including the themes such as Health Science and Waste to Wealth by the Department of Science and Technology, Department of Biotechnology and Swedish VINNOVA soon.  In his address, Ambassador KlasMolin called for a Joint Action Plan for a sustainable future and creation of more employment opportunities in both the countries. ]]> https://biospectrumindia.com/news/22/19277/creating-new-opportunities-in-ai-can-provide-effective-health-solutions-experts.html https://biospectrumindia.com/news/22/19277/creating-new-opportunities-in-ai-can-provide-effective-health-solutions-experts.html Mon, 02 Aug 2021 13:20:00 +0530 The online DST Azadi Ka Amrit Mahotsav Discourse Series New India @ 75, was recently organised by National Council for Science & Technology Communication and Vigyan Prasar. Experts highlighted that Artificial Intelligence (AI) is creating new opportunities which could not be achieved by traditional technology and could be used for healthcare as well as many other present and future challenges in various sectors, at a discourse series recently. Prof Ashutosh Sharma, Secretary, Department of Science & Technology (DST) said, “AI would not replace people but create new opportunities in various fields. It works on data, and if we could train our machines, it could do wonders for us in milliseconds by automating processes. It can be used for diagnostic purposes for various diseases, including COVID-19, and could prove very effective in remote areas where adequate health facilities are not available. The key to success in using AI for various problems is to reach out to maximum people.He spoke about how DST progressed over the last years, seeding foundational technologies, and have launched several schemes to tackle the challenges that are coming at faster speed with science, technology, and innovation-based solutions. “The emergence of disruptive and impactful technologies poses new challenges and simultaneously greater opportunities. DST is a nursery to help, nurture and grow young talents for the progress and development of the country,” he added.Anna Roy, Senior Advisor, NITI Aayog, pointed out that AI can be used effectively for various challenges of the country. “India has a number of challenges, but at the same time, we also have the advantage of being a data-rich country that has a lot of IT professionals, educationalists, and a demographic dividend. All this could prove a boon for us if we could use these for the progress and development of the country,” Roy said.   She highlighted the role NITI Aayog is playing in identifying various problems of the country and suggesting the future roadmap for India. “NITI Aayog as the leading think tank for the government and country is creating policies for widening science and technology ecosystem and to take industry and academia along for progress and development of the country in every sector,” she emphasised. ]]> https://biospectrumindia.com/news/22/19272/india-to-own-exclusive-database-for-research-and-solutions.html https://biospectrumindia.com/news/22/19272/india-to-own-exclusive-database-for-research-and-solutions.html Fri, 30 Jul 2021 17:40:00 +0530 Union Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr Jitendra Singh  has recently launched 'Biotech-PRIDE (Promotion of Research and Innovation through Data Exchange) Guidelines' developed by Department of Biotechnology (DBT), Ministry of Science and Technology.   On the occasion, Dr RenuSwarup, Secretary, Department of Biotechnology, other senior officials from the government and researchers from various institutions were also present. The minister also launched the website of the Indian Biological Data Centre, IBDC.   Initially, these guidelines will be implemented through the Indian Biological Data Centre (IBDC) at Regional Centre for Biotechnology supported by the Department of Biotechnology. Other existing datasets/ data centres will be bridged to this IBDC which will be called Bio-Grid.   "The Bio-Grid will be a National Repository for biological knowledge, information and data and will be responsible for enabling its exchange, developing measures for safety, standards and quality for datasets and establishing detailed modalities for accessing data", Dr Jitendra Singh said.    The Biotech PRIDE Guidelines will enable the exchange of information to promote research and innovation in different research groups across the country. The guidelines aim at providing a well-defined framework and guiding principle to facilitate and enable sharing and exchange of biological knowledge, information and data and is specifically applicable to high-throughput, high-volume data generated by research groups across the country.   These guidelines do not deal with a generation of biological data per se but are an enabling mechanism to share and exchange information and knowledge generated as per the existing laws, rules, regulations and guidelines of the country.      ]]> https://biospectrumindia.com/news/22/19247/centre-advises-states-to-conduct-sero-prevalence-surveys-with-icmr.html https://biospectrumindia.com/news/22/19247/centre-advises-states-to-conduct-sero-prevalence-surveys-with-icmr.html Wed, 28 Jul 2021 20:00:00 +0530 The Union Government has advised all States/UTs to conduct sero-prevalence surveys in consultation with the Indian Council of Medical Research (ICMR) to generate district-level data on sero-prevalence which is essential in formulating localized public health response measures. The Union Health Ministry has referred to the findings of the 4th round of National Sero-Prevalence Survey done by ICMR and has advised the States to conduct the sero-prevalence studies in their ownStates/UTs in consultation with ICMR, so that such studies follow a standardized protocol, and the findings of such studies can then be utilized quickly by the respective State/UT to guide objective, transparent and evidence-based public health response to COVID-19.  It has been pointed out that the Indian Council of Medical Research (ICMR) has conducted the recent National Sero-survey in 70 districts of India.  The national sero-survey by ICMR was designed to capture the extent of the spread of COVID-19 infection at the national level. Therefore, the national sero-survey results do not reflect the heterogeneity of sero-prevalence between districts and even between States. ]]> https://biospectrumindia.com/news/22/19221/c-camp-pushes-karnataka-focused-deep-science-driven-entrepreneurship.html https://biospectrumindia.com/news/22/19221/c-camp-pushes-karnataka-focused-deep-science-driven-entrepreneurship.html Fri, 23 Jul 2021 18:45:00 +0530 The Centre for Cellular and Molecular Platforms (C-CAMP), an initiative supported by Department of Biotechnology, Govt of India and Department of IT, BT, S&T Government of Karnataka, has signed a Memorandum of Understanding (MoU) with the Consulate General of the State of Israel to South India in Bengaluru to launch an Indo-Israel synergistic partnership in Science & Technology called Indo Israel Innovation Bridge. The initiative will promote cross-talk and collaborative efforts in scientific research, encourage co-development of innovations and technologies towards commercialization and leverage each other’s entrepreneurial ecosystem to nurture and accelerate start-ups. The Bridge that is a key effort in enhancing startup connectivity in the biotech sector between Israel and Karnataka, also looks to identify and link mutual R&aD efforts in both countries in Life Sciences domain. Dr Ashwathnarayan CN, Deputy Chief Minister, Government of Karnataka said, "I congratulate C-CCAMP on the occasion of Indo Israel Innovation Bridge. Collaboration and integration is the way forward. From Karnataka State Government, I promise support and close collaboration from all departments such as education, health to see that technologies developed at C-CAMP are passed on to the people.”Dr Jonathan Zadka, Consul General of Israel to South India, Bengaluru said “We are proud in establishing cooperation by building an Innovation Bridge between Israel and India, bringing closer together the startups ecosystems in life sciences of both countries. The potential of this initiative is enormous, and it has already generated tangible cooperation between startups from Israel and India. By doing so we will be consolidating existing islands of excellence spread across the two nations to create a collaborative environment for cutting-edge R&D. We look forward to supporting the Government of Karnataka to build this bridge of innovation. This new initiative will further strengthen the links between Israel and India.” ]]> https://biospectrumindia.com/news/22/19219/nha-invites-comments-on-consultation-paper-over-unified-health-interface.html https://biospectrumindia.com/news/22/19219/nha-invites-comments-on-consultation-paper-over-unified-health-interface.html Fri, 23 Jul 2021 17:55:00 +0530 The National Health Authority (NHA) released a consultation paper on the Unified Health Interface (UHI). UHI is intended to be an open, interoperable platform to connect all digital health solutions.   The consultation paper provides an overview of the proposed design, scope and role of UHI. In light of the upcoming national rollout of NDHM, comments from the public are invited to ensure that UHI is designed and developed in a collaborative and consultative manner.    Through the UHI, NDHM aims to transform the way digital health services are rendered in India. Currently, patients and healthcare providers need to be on the same application to avail and provide digital health services, respectively. It is envisioned that the open network created by UHI will serve as the digital infrastructure for patients and healthcare providers to engage in the discovery, booking, payment and fulfilment of a variety of digital health services across applications. The services include but are not limited to, teleconsultation and the discovery of pharmacies and hospitals. Over time, the services enabled by the platform will evolve with the market ecosystem. UHI is designed to be similar to the UPI (Unified Payments Interface) ecosystem which has emerged for digital payments.   Since the launch of the pilot of NDHM in August 2020 in six Union Territories, multiple rounds of consultations with different groups of stakeholders have been held for the various building blocks to discuss the design and adoption. NDHM will continue this engagement with stakeholders and ensure that development is inclusive, and that diverse viewpoint are incorporated from concerned stakeholders.   Giving his views on the consultation papers, Dr RS Sharma, CEO, National Health Authority, remarked, “The National Digital Health Mission (NDHM) is endeavouring to make digital public goods for the healthcare industry to make it more accessible, affordable and efficient. To facilitate this, we are taking a consultative approach to develop the National Digital Health Ecosystem. We have come up with the concept of Unified Health Interface (UHI), designed on similar lines as UPI (Unified Payment Interface), which has revolutionized digital payments and the financial sector. To enable inclusivity and widen the perspectives on the table, I urge all stakeholders to go through the shared consultation papers and provide us with their valuable feedback.”   NHA will also organise a public webinar on UHI to explain the consultation paper on August 4, 2021, from 3 pm onwards. ]]> https://biospectrumindia.com/news/22/19199/pharma-gmp-workshops-to-enhance-production-of-high-quality-apis-secretary-dop.html https://biospectrumindia.com/news/22/19199/pharma-gmp-workshops-to-enhance-production-of-high-quality-apis-secretary-dop.html Wed, 21 Jul 2021 15:45:00 +0530 The sixth of a series of six virtual workshops on current Good Manufacturing Practices (GMP) to support and build capacity in the quality management systems of Indian pharmaceutical industries to provide world-class quality medical products was recently inaugurated by S Aparna, Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India.    The workshop addresses the vital importance of strengthening the capacities of Indian pharma manufacturing facilities to meet the current GMP and sharing global practices to promote availability and access to quality medical products.   The initiative is the result of effective collaboration between the Union Ministry of Health & Family Welfare (MoHFW), the World Health Organization (WHO), JSS Academy of Higher Education & Research at Mysuru (JSS AHER) and the Indian Pharmaceutical Alliance (IPA).    Aparna said, “The workshops have recognised and identified some of the existing challenges and vulnerabilities and have addressed them, which reinforces the utility and the necessity of these series of workshops. This will have a far-reaching positive impact on enhancing the quality systems for the production of high-quality APIs.”   Dr VG Somani, Drugs Controller General of India, said, “The workshops have helped in creating awareness not only on the latest developments in GMP but the entire product life cycle of pharmaceuticals. The topics covered to support the planned regulatory revisions for the Indian pharma sector and support our constant endeavour that our standards are at par with the best in the world."   Speaking on the occasion, the WHO representatives from HQ, WHO Regional Office for South-East Asia, and WHO Country Office for India said that it is for the first time anywhere in the world that a programme like this has been attempted. It is a unique collaboration between the ministries, WHO, industry, academia and other stakeholders for fostering the quality and handholding of the Pharma manufacturers.      ]]> https://biospectrumindia.com/news/22/19164/cabinet-approves-change-of-nomenclature-mandate-of-neifm.html https://biospectrumindia.com/news/22/19164/cabinet-approves-change-of-nomenclature-mandate-of-neifm.html Wed, 14 Jul 2021 18:15:00 +0530 The Union Cabinet has given its approval for changing the nomenclature and mandate of the North Eastern Institute of Folk Medicine (NEIFM) as the North Eastern Institute of Ayurveda & Folk Medicine Research (NEIAFMR).   Keeping in view the need, the proposal was made to change the nomenclature and mandate of North Eastern Institute of Folk Medicine (NEIFM) to North Eastern Institute of Ayurveda & Folk Medicine Research (NEIARMR) for imparting quality education and research in Ayurveda and folk medicine at Pasighat, Arunachal Pradesh. The consequential changes will also be carried out in the Memorandum of Association & Rules and Regulations.    The inclusion of Ayurveda within the mandate of the institute will be highly beneficial for the people of the North East region for imparting quality education and research in Ayurveda and folk medicine. The institute will also provide opportunities for students of Ayurveda and Folk Medicine not only in India but also the neighbouring countries such as Tibet, Bhutan, Mongolia, Nepal, China and other Central Asian countries.   The NEIFM, Pasighat was established for systemic research, documentation and validation of traditional folk medicine and health practices of the region. The objectives for which the institute was established include to function as an apex research centre for all aspects of Folk Medicine, to create an interface between traditional healers and scientific research, survey, documentation and validation of Folk Medicine practices, remedies and therapies for possible usage in public healthcare and future research etc. ]]> https://biospectrumindia.com/news/22/19162/govt-caps-trade-margin-of-five-medical-devices-.html https://biospectrumindia.com/news/22/19162/govt-caps-trade-margin-of-five-medical-devices-.html Wed, 14 Jul 2021 17:40:00 +0530 The National Pharmaceutical Pricing Agency (NPPA) has vide its notification dated 13.07.2021, capped the trade margin up to 70 per cent on Price to Distributor (PTD) level on the pulse oximeter, blood pressure monitoring machine, nebulizer, digital thermometer and glucometer.    Earlier, in February 2019 NPPA had previously capped the trade margin on anti-cancer Drugs and on June 3, 2021, for oxygen concentrators. Based on the notified trade margin, NPPA has instructed the manufacturers/importers to report revised MRP within seven days. Revised MRPs will be informed in the public domain thereafter by NPPA. The revised prices will come into effect from July 20, 2021.   Every retailer, dealer, hospital and institution shall display price lists of these medical devices as furnished by the manufacturer, on a conspicuous part of the business premises in a manner to be easily accessible to any person wishing to consult the same.   The manufacturers/importers not complying with the revised MRP after Trade Margin capping shall be liable to deposit the overcharged amount along with interest @15 per cent and penalty up to 100 per cent under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955.    State Drug Controllers (SDCs) shall monitor the compliance of the order to ensure that no manufacturer, distributor, a retailer shall sell these medical devices to any consumer at a price exceeding the revised MRP, to prevent instances of black-marketing.   The order shall be applicable up to January 31, 2022, subject to review. ]]> https://biospectrumindia.com/news/22/19142/union-health-minister-inaugurates-two-psa-oxygen-plants-in-bhavnagar.html https://biospectrumindia.com/news/22/19142/union-health-minister-inaugurates-two-psa-oxygen-plants-in-bhavnagar.html Mon, 12 Jul 2021 20:40:00 +0530 Union Minister of Health and Family Welfare and Minister of Chemical and Fertilizers, Mansukh Mandaviya virtually inaugurated two PSA plants at Sir Takhtasinhji Hospital, Bhavnagar. Along with two oxygen generation plants of 1000 LPM capacity each, a copper piping network and associated facilities like a fire fighting system and automatic oxygen source changeover system were also inaugurated.The occasion was also graced by Shantanu Thakur, Union Minister of State for Ports, Waterways and Shipping and Shripad Yesso Naik, Union Minister of State for Tourism and Ports, Shipping and Waterways.Speaking on the occasion, Mandaviya said, “This facility is dedicated to the people of Bhavnagar. Similar such facilities inaugurated recently would help the country in times of crisis.” The Deendayal Port Trust through its corporate social responsibility has installed the two medical oxygen PSA units at Sir Takhtsinhji Hospital, Bhavnagar, run by the Government of Gujarat, at a total cost of Rs 2.53 crores. The installed PSA oxygen generator unit has the capacity of 1000 LPM (litres per minute) each, i.e., 60,000 litres/hr at 5-6 bar pressure of each unit totalling 1,20,000 litres/hr, which can be utilised for the treatment of COVID as well as other patients of all mankind in the locality, at the hospital.   ]]> https://biospectrumindia.com/news/22/19121/mohfw-organises-capacity-building-workshop-for-health-correspondents-of-ne-states.html https://biospectrumindia.com/news/22/19121/mohfw-organises-capacity-building-workshop-for-health-correspondents-of-ne-states.html Fri, 09 Jul 2021 10:00:00 +0530 Union Ministry of Health and Family Welfare (MoH&FW) in partnership with UNICEF, held a capacity building workshop for media professionals and health correspondents of North Eastern States on the current COVID situation in India, the need to bust myths about COVID vaccines and vaccination, and reinforce the importance of COVID Appropriate Behaviour (CAB). Media professionals and health correspondents of North Eastern States of Assam, Arunachal Pradesh, Meghalaya, Mizoram, Manipur, Nagaland, Sikkim and Tripura participated in the workshop virtually.Lav Agarwal, Joint Secretary, Union Health Ministry addressed the workshop, which was attended by more than 130 health journalists and senior officials of DD News, All India Radio, Press Information Bureau (PIB) of these states. Agarwal, in his opening remark, commended media professionals for their sustained efforts in the collective fight against COVID-19. He said that media persons are major influencers of society as they can encourage people to vaccinate and follow COVID Appropriate Behaviour. He acknowledged that the media plays a constructive role in overcoming vaccine hesitancy by busting myths and fake news that is widely shared on social media platforms.Highlighting India’s COVID-19 management strategy, he said that there are three important components of the fight against covid i.e community ownership of covid appropriate behaviour, evidence-based reporting and busting myths on covid and vaccination. Agarwal while giving a brief snapshot of the prevailing COVID-19 situation in North East India said that 80 per cent of new cases in India reported from 90 districts and 14 out of 90 districts are from North-Eastern states. Highlighting specific challenges linked to the North Eastern States, he added that the Government of India has supported North Eastern States by following a proactive, pre-emptive, graded approach for fighting the COVID pandemic. He also shared the details of active cases and the status of vaccination drives in the North-Eastern states. Acknowledging the media as an important stakeholder in creating an enabling environment for vaccination by busting myths, fears and apprehensions surrounding COVID vaccination, he added that more than 36.48 crore vaccine doses have been administered in the country to date. He urged media persons to create a Jan Andolan (Public Movement) by applauding community warriors as role- models.Besides various reasons for vaccine hesitancy, which may be local and could vary for different community groups, the workshop highlighted Adverse Event Following Immunization (AEFI), its management, and the best practices while reporting on AEFI. Various queries of the media persons were also addressed during the workshop.Senior officials of the Union Ministry of Health and Family Welfare, Ministry of I&B, UNICEF, DD News, PIB, AIR News and health journalists from across the country participated in the national workshop. ]]> https://biospectrumindia.com/news/22/19120/cabinet-approves-covid-preparedness-package-worth-rs-23123-cr.html https://biospectrumindia.com/news/22/19120/cabinet-approves-covid-preparedness-package-worth-rs-23123-cr.html Fri, 09 Jul 2021 09:30:00 +0530 The Union Cabinet chaired by Prime Minister Shri Narendra Modi has approved a new scheme ‘India COVID-19 Emergency Response & Health System Preparedness Package: Phase-II’ amounting to Rs 23,123 crore for FY 2021-22. The scheme aims to accelerate health system preparedness for immediate responsiveness for early prevention, detection and management, with the focus on health infrastructure development including paediatric care and with measurable outcomes. The Phase-II of the Package has Central Sector (CS) and Centrally Sponsored Schemes (CSS) components.Under the Central Sector components: Support would be provided to Central Hospitals, AIIMS, and other Institutions of National Importance under DoHFW (at VMMC & Safdarjung Hospital, Delhi, LHMC & SSKH, Delhi, RML, Delhi, RIMS, Imphal and NEIGRIMS, Shillong, PGIMER, Chandigarh, JIPMER, Puducherry and AIIMS Delhi (existing AIIMSs) and new AIIMSs under PMSSY) for repurposing 6,688 beds for COVID management. National Centre for Disease Control (NCDC) would be strengthened by providing Genome Sequencing machines, besides sanctioning Scientific Control room, Epidemic Intelligence Services (EIS) and INSACOG Secretariat support.   Support would be provided for the implementation of the Hospital Management Information System (HMIS) in all the District Hospitals of the Country (presently, it is implemented only in 310 DHs). All district –hospitals would implement HMIS through NIC developed E-Hospital and CDAC developed E-Shushrutsoftwares. This will be the biggest impetus for the implementation of the National Digital Health Mission (NDHM) at the DHs. This support includes the support provided to the District Hospitals towards augmentation of the hardware capacity. Support would also be provided for expanding the National Architecture of eSanjeevani Tele-consultation platform to provide up to 5 lakhs teleconsultations per day from the present 50,000 Tele-consultations per day. This includes support to the States/UTs to enable teleconsultations with the COVID patients at the COVID Care Centres (CCCs) by strengthening Hubs for eSanjeevani Teleconsultation in all the districts of the country. Support would also be provided for IT interventions, including strengthening the Central War room at DoHFW, strengthening Country’s COVID-19 Portal, 1075 COVID helplines and COWIN platform.   Under the CSS components, the efforts are aimed at strengthening district and sub district capacity for an effective and rapid response to the pandemic. States/UTs would be supported to: Create paediatric units in all 736 districts and also, establish Paediatric Centre of Excellence (PaediatricCoE) in each State/UT, (either in Medical Colleges, State Govt. Hospitals or Central Hospitals such as AIIMS, INIs, etc) for providing Tele-ICU services, mentoring and technical hand-holding to the District Paediatric units.    Augment 20,000 ICU beds in public healthcare system out of which 20 per cent will be paediatric ICU beds.    Provide care closer to the community due to the ingress of COVID-19 in rural, peri-urban and tribal areas, by creating pre-fabricated structures for adding additional beds at the existing CHCs, PHCs and SHCs (6-20 bedded units) and support would also be provided to establish bigger field hospitals (50-100 bedded units) depending on the needs at tier-II or Tier-III cities and district HQs.    Install 1050 numbers of liquid medical oxygen storage tanks with Medical Gas Pipeline System (MGPS), with an aim to support at least one such unit per district.   Augment the existing feet of ambulances - 8,800 ambulances will be added under the package. Engage Undergraduate and postgraduate medical interns and final year MMBS, BSc, & GNM nursing students for effective COVID management. As “Test, Isolate and Treat” and following-up COVID Appropriate Behaviour at all the times, is the national strategy for effective COVID-19, support is provided to the States to maintain at least 21.5 lakhs per day. Flexible support to the districts for meeting the requirement of essential medicines for COVID-19 management, including creation of buffer stock.    "India COVID-19 Emergency Response and Health Systems Preparedness Project: Phase-II" would be implemented at a total cost of ₹ 23,123 Crore, till March 31, 2022 with central and state share as under:    Central Share of the ECRP-II –Rs 15,000 crore    State Share of the ECRP-II –Rs 8,123 crore With the focus on immediate needs for the next nine months of FY 21-22, to provide support to Central government hospitals/agencies and to State/UT Governments to augment their existing response to the second wave and the evolving pandemic, including at district and sub-district levels in peripheral facilities. ]]> https://biospectrumindia.com/news/22/19094/ayush-ministry-launches-five-portals-pertinent-to-ayurveda-rd.html https://biospectrumindia.com/news/22/19094/ayush-ministry-launches-five-portals-pertinent-to-ayurveda-rd.html Tue, 06 Jul 2021 00:00:00 +0530 At a virtual event on 5 July, Union Minister of Ayush (IC) Kiran Rijiju launched the Clinical Trials Registry- India (CTRI) portal pertinent to Ayurveda Dataset along with AMAR, RMIS, SAHI and e-Medha portals. After the inclusion of dataset pertinent to Ayurveda in CTRI portal, the Ayurveda Clinical Trials would have worldwide visibility and will further the cause of strengthening Ayurvedic Research.The SAHI portal incorporates authentic resources and will be of immense help in showcasing the historical veracity of Ayurveda. With the help of the e- Medha portal, anyone will have online access to more than 12 thousand books. These books are related to Indian Medical Heritage and can be accessed through NIC’s e- granthalaya platform. AMAR portal, which was also launched, is a repository for Ayurveda, Yoga, Unani, Siddha and Sowa- Rigpa Manuscripts and catalogues. Another portal CCRAS- Research Management Information System or RMIS in short, is a research guidance platform. Apart from these five portals, four publications were also released by the Ministry of Ayush- Proceedings of International workshop on” Preservation and Promotion of SOWA-RIGPA in Asia; Compendium of Important Cereals mentioned in Ayurveda-Series-1, volume-1; Ayurveda Sangraha: An important classical textbook of Ayurveda which is mentioned in the Schedule 1 of Drugs and Cosmetics Act 1940. Up till now this book was available in Bengali language. Now it has been transliterated to Devanagari Script; and PathapathyaVinishcaya- An important book of Ayurveda and has details of diet and lifestyle. ]]> https://biospectrumindia.com/news/22/19087/dbt-sets-up-two-covid-19-vaccine-testing-facilities-in-pune-hyderabad.html https://biospectrumindia.com/news/22/19087/dbt-sets-up-two-covid-19-vaccine-testing-facilities-in-pune-hyderabad.html Mon, 05 Jul 2021 11:15:00 +0530 Department of Biotechnology, Ministry of Science & Technology , Government of India has set up two vaccine testing facilities in its Autonomous Research Institutes National Centre for Cell Science (NCCS), Pune, and National Institute of Animal Biotechnology,(NIAB) Hyderabad as Central Drug Laboratory (CDL), for batch testing and quality control of vaccines. Accordingly, with funding support provided by the PM-CARES Funds trust, two new vaccine testing facilities have been set up as Central Drug laboratories at DBT- NCCS, and DBT-NIAB. DBT-NCCS and DBT-NIAB have been the pillars for many aspects of infectious disease-related work in India and have contributed to the advancement of cutting-edge research output in frontier areas of Biotechnology relevant to human health and disease. The facility at NCCS, Pune, has now been notified as Central Drugs Laboratory for testing and lot release of COVID-19 vaccines vide. Gazette notification issued by the Ministry of Health & Family Welfare on June 28, 2021. The facility at NIAB, Hyderabad is likely to receive necessary notification shortly. The facilities are expected to test approx 60 batches of vaccines per month. The facilities are geared up to test existing COVID-19 vaccines and other newer COVID-19 vaccines as per the demand of the Nation. This will not only expedite the Vaccine manufacture and supply but also be logistically convenient considering that both Pune and Hyderabad are the two vaccine manufacturing hubs.  ]]> https://biospectrumindia.com/news/22/19084/vice-president-calls-for-fast-tracking-of-genome-sequencing-of-new-covid-19-variants.html https://biospectrumindia.com/news/22/19084/vice-president-calls-for-fast-tracking-of-genome-sequencing-of-new-covid-19-variants.html Fri, 02 Jul 2021 16:00:00 +0530 The Vice President (VP) of India, M Venkaiah Naidu has called for fast-tracking of genome sequencing of new COVID-19 variants to speed up finding suitable vaccines and drugs. Naidu visited CCMB’s LaCONES (Laboratory for the Conservation of Endangered Species) facility soon after his arrival in Hyderabad. He witnessed a presentation by Scientist-in-charge of LaCONES, Dr. Karthikeyan Vasudevan and visited National Wildlife Genetic Resource Bank, Assisted Reproduction Lab and animal cages at the facility. Addressing scientists and research scholars, he observed that sequencing, as an adjunctive tool, plays a critical role in identifying the emergence of new viral mutations and thus helps combat the spread of COVID-19. He also stressed the need for strengthening international collaborations by research institutions to study the feasibility of developing a universal vaccine that could neutralize various SARS-CoV-2 variants. Pointing out that the easy transmissibility of Coronavirus poses many challenges, he said the way in which it might infect new hosts or other species will be an important area of research.  ]]> https://biospectrumindia.com/news/22/19079/union-health-minister-addresses-17th-world-congress-for-cervical-pathology-colposcopy.html https://biospectrumindia.com/news/22/19079/union-health-minister-addresses-17th-world-congress-for-cervical-pathology-colposcopy.html Fri, 02 Jul 2021 15:45:00 +0530 Dr Harsh Vardhan, Union Minister for Health and Family Welfare addressed an audience of eminent doctors, professors of medical science and stalwarts of medical fraternity specialising in cervical pathology and colposcopy through video conference at the inaugural session of the 17th World Congress for Cervical Pathology and Colposcopy.   The event organised by the Indian Society of Colposcopy and Cervical Pathology was inaugurated by the Vice President of India Venkaiah Naidu. Dr Vardhan congratulated the Indian Society of Colposcopy and Cervical Pathology for pioneering training in colposcopy and treatment of precancerous lesions of the cervix and for bringing the World Congress for the first time to Asia. The theme of the World Congress 'Eliminating Cervical Cancer: Call for Action' is aligned to the WHO call for Elimination of Cervical Cancer by 2030, he stated.   Speaking on the topic of cervical cancer, the Union Health Minister said, “It is the fourth most common cancer in women. It affects over half a million women across the world each year and kills a quarter of a million. Tragically, one woman dies of cervical cancer every two minutes, making it one of the greatest threats to women’s health. The sad part is that our women are suffering and dying even though when diagnosed cervical cancer is one of the most successfully treatable forms of cancer, as long as it is detected early and managed effectively. Cancers diagnosed in late stages can also be controlled with appropriate treatment and palliative care. With a comprehensive approach to prevent, screen and treat, cervical cancer can be eliminated as a public health problem within a generation.”   Dr Vardhan also highlighted the crucial role undertaken by India to stop cervical cancer heeding to WHO’s 2030 target. He said, "I can proudly state that India is one of the few developing countries that have formulated the national cancer control program. As a leader in Asia, in 2016, we have launched the operational guidelines for screening of common cancers - cervical, breast, oral and Cervical Cancer. India along with 194 other countries has collectively resolved to work together for the elimination of this major killer a goal which is achievable through 90 per cent HPV vaccination coverage, 70 per cent screening coverage and 90 per cent treatment for cervical precancer and cancer including access to palliative care.”    The Union Health Minister explained how the Government of India is offering the intervention to end cancer through the two wings of the Ayushman Bharat Programme.   ]]> https://biospectrumindia.com/news/22/19058/cabinet-approves-mous-with-nepal-myanmar-for-health-research.html https://biospectrumindia.com/news/22/19058/cabinet-approves-mous-with-nepal-myanmar-for-health-research.html Wed, 30 Jun 2021 17:00:00 +0530 The Union Cabinet, chaired by the Prime Minister Narendra Modi was apprised of a Memorandum of Understanding (MOU) signed between Indian Council of Medical Research (ICMR), India and the Department of Medical Research (DMR), Ministry of Health and Sports of Myanmar signed oin February, 2020 at New Delhi. The objective of this MoU is to build on the health research relationship in the topics of mutual research.  The main objectives are: Elimination of infectious diseases (to be decided mutually) Development of network platform of emerging and viral infections Training /capacity building in research methodology management, clinical trials, ethics etc. Harmonization of regulatory mechanism   Additionally, the Union Cabinet was also apprised of a Memorandum of Understanding (MOU) signed between Indian Council of Medical Research (ICMR), India and the Nepal Health Research Council (NHRC), Nepal in 17 November 2020 and 4 January 2021 respectively. The objectives of this MOU are collaboration on joint research activities of mutual interest such as cross-border health issues, Ayurveda/traditional medicine  and medicinal plants, climate change and health, non-communicable diseases, mental Health, Population based cancer registry, tropical diseases (Vector borne diseases such as Dengue, Chikungunya, malaria, JE etc.), Influenza, Clinical Trial Registry, health research ethics, Capacity building through exchange of knowledge, skills tools and fellows and Collaboration for adoption of tools, guidelines, protocols and best practices related to health research. ]]> https://biospectrumindia.com/news/22/19042/niti-aayog-brings-out-report-on-not-for-profit-hospital-model-in-india.html https://biospectrumindia.com/news/22/19042/niti-aayog-brings-out-report-on-not-for-profit-hospital-model-in-india.html Tue, 29 Jun 2021 13:00:00 +0530 NITI Aayog has released a comprehensive study on the not-for-profit hospital model in the country, in a step towards closing the information gap on such institutions and facilitating robust policymaking in this area.  “There has been relatively low investment in the expansion of the health sector in the private domain.The stimulus announced yesterday provides us an opportunity to change this situation. The report on the not-for-profit sector is a small step in that direction,” said Dr VK Paul, Member (Health), NITI Aayog. NITI Aayog has been extensively studying the private-sector healthcare-delivery landscape in the country. While there exists adequate information on for-profit healthcare providers and institutions, there is a dearth of reliable and structured information on their not-for-profit counterparts, known for their tireless service in making quality healthcare accessible and affordable to everyone. The not-for-profit hospital sector provides not only curative but also preventive healthcare. It links healthcare with social reform, community engagement, and education. It uses government resources and grants to provide cost-effective healthcare to people without being concerned about profits. However, over the years, this sector has remained understudied. The study discusses in detail the cost-containment strategies implemented by not-for-profit hospitals. It seeks to understand the challenges that burden the operations of these institutions and hinder their growth. The report proposes short- and long-term policy interventions—such as developing criteria to identify these hospitals, ranking them through a performance index, and promoting top hospitals for practising philanthropy, among others. It also highlights the need to use the expertise of these hospitals in managing human resources with limited finance in remote areas. ]]> https://biospectrumindia.com/news/22/19035/govt-announces-rs-23220-cr-more-for-public-health.html https://biospectrumindia.com/news/22/19035/govt-announces-rs-23220-cr-more-for-public-health.html Mon, 28 Jun 2021 19:55:00 +0530 Finance Minister (FM) Nirmala Sitharaman at a press conference has announced Rs 23,220 crore earmarked for one year for healthcare, with funding for short-term HR augmentation through medical students (interns, residents, final year) and nursing students; Increasing availability of ICU beds, oxygen supply at central, district and subdistrict level; Ensuring adequate availability of equipment, medicines; access to teleconsultation; ambulance services; and Enhancing testing capacity and supportive diagnostics, strengthen capacity for surveillance and genome sequencing. Rs 1.10 lakh crore Loan Guarantee Scheme for COVID Affected sectors has been announced. Under this new scheme, additional credit of Rs 1.1 lakh crore will flow to the businesses. This includes Rs 50,000 crore for health sector and Rs 60,000 crore for other sectors, including tourism. Rs 50,000 crore relief for the health sector is aimed at up scaling medical infrastructure targeting underserved areas. It guarantees cover for expansion and new projects related to health/medical infrastructure in cities other than 8 metropolitan cities. FM has also announced that Rs 15,000 crore emergency health systems project led to 25 fold increase in coroanvirus dedicated hospitals, setting up of 7,929 Covid health centres, 9,954 Covid care centre, 7.5 times increase in oxygen supported beds, 42 fold increase in isolation beds, 45 fold increase in ICU beds. There is also a new scheme focused on short term emergency preparedness with special emphasis on children and paediatric care/paediatric beds. A total relief package of Rs 6,28,993 crore has been announced by Nirmala Sitharaman to support Indian economy in fight against COVID-19 pandemic.  "Measures announced by FM will enhance public health facilities, especially in under-served areas, boost private investment in medical infrastructure and augment critical human resources. Special focus is on strengthening healthcare facilities for our children", tweeted Prime Minister Narendra Modi.   Click here for industry responses...   ]]> https://biospectrumindia.com/news/22/19027/german-indian-biotech-cos-vedicinals9-shows-promising-result-in-treating-covid-19.html https://biospectrumindia.com/news/22/19027/german-indian-biotech-cos-vedicinals9-shows-promising-result-in-treating-covid-19.html Mon, 28 Jun 2021 10:45:00 +0530 Vedicinals, a German-Indian biotech company based in Pune, has recently announced the results of a WHO registered randomised clinical trial using its Indian regulatory authority approved nutraceutical compound called Vedicinals9. The clinical trial involved 124 patients who showed improvements of various key biomarkers such as IL-6 and CRP, faster resolution of clinical symptoms such as fever, cough, fatigue etc and also organ protection.    Yogendra Kumar Choudhary, Chief Research Officer, Vedicinals and CEO, Ethix Pharma commented, “The study demonstrated that 58 per cent of patients in the Vedicinals9 treatment group were discharged from hospital in the first four to seven days of testing positive compared to the 37 per cent standard care treatment group with improvement to 77.05 per cent of normal X-ray findings in 12 days.”   Vedicinals9 consists of nine bioactive molecules including Baicalin, Quercetin, Luteolin, Rutin, Hesperedin Curcumin, Epigallocatechin Gallate, Piperine, Glycyrrhizin. All these nine bioactive molecules were selected based on silico studies, meta-analysis of past published studies, various studies on their drug target pathways and also their ability to be able to correct or stop various human host cellular pathways disruptions caused by the SARS-CoV-2 coronavirus. Details of these are found in the Vedicinals9 white paper. These nine bioactive molecules also have supporting published studies conducted by other research teams showing their individual efficacy against the SARS-CoV-2 coronavirus.   Vedicinals9 has already gone through safety studies including toxicity and myocardial infarction studies involving Sprague Dawley Rats. Vedicinals9 has already been used in a variety of hospital settings throughout India with positive results and is now available throughout the country at leading hospitals, clinics, pharmacies and also through Vedicinals own online shop.   The product is being sold at a net price of about $135 for the Indian market for a set of 14 doses. The product is currently undergoing observational clinical studies in Columbia, Brazil, Iran and Pakistan. A larger randomised human clinical trial is being planned for the US in the state of Oregon and also in the UK. The product is also undergoing regulatory approval as a nutraceutical supplement in Japan, Thailand, Australia, Indonesia and Singapore.   A major deal is currently underway for one of the largest nutraceutical brands in the US to develop the same product based on OEM and license of formulation agreement.   Prakash Salunke, MD, Vedicinals said, “As of Today (21st June 2021) our product Vedicinals-9 is certified as a nutraceutical product in India by the FSSAI. Our FSSAI License no 10020028000199. As a result of the conclusion of our WHO registered randomized human clinical trial with results reported to both CTRI India ((trial number CTRI – CTRI/2020/10/028364) as will a WHO, we are in the midst of upgrading our certification to that as Food For Specific Medical Purpose (FSMP) which will soon be granted by the FSSAI."   Joachim Gerlach, Chairman, Vedicinals added, “My main motivation to dedicate so much time and effort into the development of an adjuvant covid therapeutic product is part of our corporate philosophy of long-lasting and genuine care for people's wellbeing.”   ]]> https://biospectrumindia.com/news/22/19024/niti-aayog-organises-convention-on-obesity.html https://biospectrumindia.com/news/22/19024/niti-aayog-organises-convention-on-obesity.html Fri, 25 Jun 2021 18:20:00 +0530 NITI Aayog convened the National Convention on Prevention of Maternal, Adolescent and Childhood Obesity under the chairmanship of Dr VK Paul, Member (Health), NITI Aayog and Co-chairmanship of Dr R Hemalatha, Director, Nutrition Institute of India.    Dr Rakesh Sarwal, Additional Secretary (Health and Nutrition), NITI Aayog described obesity as a 'silent epidemic.' In the National Consultation global experts, representatives from UN bodies, central ministries and national research institutions presented their evidence regarding the increasing prevalence of obesity and presented best practices for obesity reduction.   Arjan de Wagt, Chief Nutrition, UNICEF presented evidence on the increasing burden of overnutrition in India. Professor William Joe, IEG shared valuable data on the current and emerging trends of obesity in certain geographies of India.    Shariqua Yunus, Head of Unit and Programme Officer (Health and Nutrition), WFP emphasised the need to diversify food-based social safety nets to prevent obesity. Monika Arora, Director of Health Promotion Division, PHFI along with Rachita Gupta, National Professional Officer (Nutrition) WHO deliberated on obesogenic marketing strategies on Indian Television. Global experts Kathryn Backholer, Professor at Deakin University and Tim Lobstein, Policy Director, World Obesity Federation conveyed how the obese population is an unhealthy population and the cost of treating obesity is the cost of junk food marketing.   In the convention, Secretaries of the Ministry of AYUSH and the Department of Youth Affairs placed their suggestions on promoting healthy behaviour. Senior officers of the Ministry of Health & Family Welfare, Ministry of Women & Child Development, Ministry of Human Resource Development and Ministry of Information & Broadcasting echoed the need for introducing behavioural change and a favourable policy landscape. UNICEF Country representative, YasmineHaque also endorsed the same.   All panellists expressed the unanimous need to address this issue on a priority basis, with a resounding emphasis on better mass communication around encouraging physical activity, healthy eating and lifestyle. A need for a whole of government and a whole of society approach was emphasised in tackling the twin challenge of obesity and under. An urgent need for adopting strategies related to fiscal measures, regulating front-of-package labelling, promoting a healthy diet, physical activity and lifestyle options emerged as key themes for future deliberations and actions.    In conclusion, Dr VK Paul, Member (Health and Nutrition), NITI Aayog called for a multi-sectoral approach targeting the adolescents to promote activity and a healthy lifestyle.        ]]> https://biospectrumindia.com/news/22/19017/union-health-minister-chairs-tb-mukt-bharat-partner-meeting.html https://biospectrumindia.com/news/22/19017/union-health-minister-chairs-tb-mukt-bharat-partner-meeting.html Fri, 25 Jun 2021 10:55:00 +0530 Dr Harsh Vardhan, Minister of Health & Family Welfare, chaired Tuberculosis (TB) Mukt Bharat meeting with various development partners of the Health Ministry through video conferencing. It was the 4th meeting chaired by the Union Health Minister for reviewing the progress in the fight against TB.Speaking at the meeting, Dr Vardhan said that the media, especially Doordarshan, had played a crucial role in the eradication of polio in the country. On similar lines, journalists and media personalities should be made TB crusaders to create awareness amongst the people. He expressed the need to develop an institutionalised mechanism to share the best practices, experiences and ideas used in the fight against TB. He emphasised the importance of leadership and community involvement, proposing that religious leaders, leaders of auto unions etc. can be roped in to create awareness against TB. He said that there is a need to develop prototypes and clear strategies for five states having high TB caseload. These states are Uttar Pradesh, Madhya Pradesh, Meghalaya, Himachal Pradesh and Telangana.Dr Vardhan expressed satisfaction over the efforts being made by various developmental partners and said that “together we are proceeding in the right direction”. He said that the fight against COVID and TB have to go hand in hand. He expressed hope that India will be able to eradicate TB by 2025 as envisaged by the Prime Minister if we put our mind, heart and soul together to eliminate TB. Expressing satisfaction over the progress made by the country in the fight against TB, Minister of State, MoH&FW, Ashwini Kumar Choubey said that a Jan Andolan is required to eradicate TB. He underlined the need to have a grass root level visits in villages and slums, fully equipped with testing machines and other services to help people. Rajesh Bhushan, Secretary, MoH&FW expressed the need to involve the Corporate sector and Community in the fight against TB. He suggested micro-planning, on the lines of COVID vaccination strategy for TB in states with high TB caseload. He further emphasised the need for active collaboration between Government and Developmental partners. Senior Officials of the Ministry, WHO representative to India, representatives of various Development Partners, NGOs and State representatives also attended the meeting. ]]> https://biospectrumindia.com/news/22/19013/govt-inks-mizoram-health-systems-strengthening-project-with-wb-for-32m.html https://biospectrumindia.com/news/22/19013/govt-inks-mizoram-health-systems-strengthening-project-with-wb-for-32m.html Thu, 24 Jun 2021 17:00:00 +0530 The Government of India, Government of Mizoram and the World Bank (WB) have signed a $32 million Mizoram Health Systems Strengthening Project to improve management capacity and quality of health services in Mizoram, particularly for the benefit of under-served areas and vulnerable groups. The project will strengthen the governance and the management structure of the Department of Health and Family Welfare (DoHFW) and its subsidiaries, improve the quality and coverage of services delivered by the state government health systems, and invest in a comprehensive Quality Assurance program which would enable quality certification of health facilities. A key focus will be to strengthen the effectiveness of the state health insurance programme; build synergies with the Government of India’s Pradhan Mantri Jan Arogya Yojna (PMJAY); and thereby reduce financial barriers in accessing hospital services, prevent catastrophic out of pocket expenditure for health by poor families and expand coverage. The Mizoram Health Systems Strengthening Project will benefit the people across all eight districts of the state. It will also benefit health sector staff, specifically at the secondary and primary levels, by strengthening their planning and management capacity along with building their clinical skills and competencies. The agreement was signed on 17.06.2021 by Shri Rajat Kumar Mishra, Additional Secretary, Department of Economic Affairs, Ministry of Finance on behalf of the Government of India; Shri Eric Zomawia, Project Director, Mizoram Health Systems Strengthening Project on behalf of the Government of Mizoram; and Mr. Junaid Ahmad, Country Director, India on behalf of the World Bank. As a key strategy, the project will move towards a performance-based financing system where Internal Performance Agreements (IPAs) between the DoHFW and its subsidiaries would foster more accountability at all levels. This is expected to go a long way in improving the management of the system to deliver quality health services. The project will also focus on promoting synergy between various schemes and augment the capacity of the state insurance agency.   ]]> https://biospectrumindia.com/news/22/19009/mohfw-organises-capacity-building-workshop-for-health-correspondents-on-covid-19.html https://biospectrumindia.com/news/22/19009/mohfw-organises-capacity-building-workshop-for-health-correspondents-on-covid-19.html Thu, 24 Jun 2021 11:00:00 +0530 Union Ministry of Health and Family Welfare in partnership with UNICEF, held a capacity building workshop for media professionals and health correspondents across the county on the current COVID situation in India, the need to bust myths about COVID vaccines and vaccination, and reinforce the importance of COVID Appropriate Behaviour (CAB). Rajesh Bhushan, Union Health Secretary addressed the national workshop which was attended by more than 300 health journalists and senior officials of DD News, All India Radio, Press Information Bureau of various States/UTs. At the outset, the health secretary thanked all the media professionals for their sustained efforts in the fight against COVID-19. He remarked that the media is the most important pillar with a social responsibility to inform and educate the masses in our collective fight against COVID-19. "As the second wave stabilises and the daily cases are seen to be declining across the country, the focus should be on vaccination and overcoming vaccine hesitancy," he stated. He added that as per the revised vaccination guidelines, vaccines are now free for 18 plus across the country and people should be encouraged to get vaccinated. “Media has always been a valuable partner in fighting the pandemic. Multi-stakeholder and sustained campaigns like COVID-19 vaccination have to effectively counter fake news/myths and the role of media becomes vital in countering myths,” the health secretary mentioned. He added that as we move forward, the need of the hour is to follow the five-pronged Strategy of COVID Appropriate Behaviour, Testing, Tracing, Treatment and Vaccination. "Considering the dynamic clinical nature of the SARS-COV2 virus, vaccination and COVID Appropriate Behaviour (CAB) consisting of wearing the mask properly, frequent hand washing and maintaining six feet distance remain the most important interventions to contain the pandemic," he said.Giving a brief snapshot of the COVID strategy adopted by the Government of India, Lav Agarwal, Joint Secretary, MoHF&W said that community participation is key to containing the virus. He added that the virus knows no boundaries and centre-state coordination and community involvement are of paramount importance in the collative and collaborative fight of the pandemic. As the country unlocks gradually, the risk of social and other gathering increases the potential chances of virus transmission, he said. “Communication messages have become a blind spot for many people, which can create low-risk perception or simply go unheeded. We need to innovate our messaging and the media can play a great role in this,” he added.Besides learning about the various reasons for vaccine hesitancy, which may be local and could vary for different community groups, the participating journalists also learnt about Adverse Event Following Immunization (AEFI), its management, and the best practices while reporting on AEFI. ]]> https://biospectrumindia.com/news/22/19002/bcg-gapio-release-papers-on-allied-healthcare-and-nurses-to-niti-aayog.html https://biospectrumindia.com/news/22/19002/bcg-gapio-release-papers-on-allied-healthcare-and-nurses-to-niti-aayog.html Wed, 23 Jun 2021 12:15:00 +0530 Boston Consulting Group (BCG) in association with the Global Association of Physicians of Indian Origin (GAPIO) have jointly released two position papers with the aim to augment the healthcare worker capacity in India. Titled 'Reimagining Nurse’s Role in India' and 'Formalizing Allied Healthcare Workforce in India, the detailed papers shed light on the solutions for augmenting healthcare workforce capacity in India and were presented to Dr Vinod Paul member NITI Aayog and Amitabh Kant CEO, NITI Aayog. The papers propose an integrated strategy.    According to Dr Prathap C Reddy, Founder President, GAPIO and Founder Chairman, Apollo Hospitals Group, “Nurses are the backbone of every health system. They account for 50 per cent of the global health workforce, their roles are diverse from devoting their lives to caring for mothers and children, giving lifesaving immunisations and health advice and looking after all age groups including the older people. Given the continued shortage of both nurses and allied healthcare workforce in the overall healthcare system, India needs to review and drive transformation in this sector holistically.”   Dr Anupam Sibal, President, GAPIO and Group Medical Director, Apollo Hospitals Group said, “It is crucial to plan a holistic strategy for the nursing workforce in India that can comprehensively solve the challenges of adequate nursing staff as well as the quality of education and training of nurses in India.”   Dr Nandakumar Jairam, Vice President, GAPIO said, “We continue to face challenges in terms of the quality of allied healthcare professionals. While there has been some progress, India still has a long way to go in formalising this segment of the workforce and introduce the right quality controls."   Dr Sudhir Parikh, Secretary-General, GAPIO, added, “Studies from MOH&FW and NSSO indicate that demand for allied healthcare workers is significantly higher than supply, with disparity also being observed across states. India could need 60,00,000 - 70,00,000 total AHP by the year 2024. The current training capacity at ~1.5 lakh seats per year would fall short of achieving our objectives. We need to enhance both the capacity and quality of healthcare workforce”.   Priyanka Aggarwal, MD and Partner, Boston Consulting Group “Solutions for issues concerning nursing, need to address lack of college infrastructure, focusing on states with limited infrastructure. Tagging of colleges with operational multispecialty hospitals needs to be developed. The attractiveness of the profession needs to be enhanced for better fill rates; including through building social respect for the profession and strengthening professional development and progression. There is an opportunity to enhance current skilling pedagogy and adopt new methodologies and telenursing, robotic nursing, forensic nursing etc. and adopt the global best practices. The availability of training faculty for nursing colleges also needs to be improved.”   Kshitij Vijayvargiya, Partner, Boston Consulting Group said, “College infrastructure needs to be enhanced and awareness about job opportunities needs to be increased. The attractiveness of the profession needs to be increased by enhancing awareness in secondary schools, formalisation of staffing and deployment norms and making career progression easier."       ]]> https://biospectrumindia.com/news/22/18978/api-with-abbott-launch-therapy-specific-teleconsultation-recommendations.html https://biospectrumindia.com/news/22/18978/api-with-abbott-launch-therapy-specific-teleconsultation-recommendations.html Mon, 21 Jun 2021 15:15:00 +0530 The Association of Physicians of India (API) has launched therapy-specific teleconsultation recommendations, in collaboration with Abbott. The robust set of recommendations outlines best practices on adopting teleconsultation across various therapeutic areas, currently catering specifically to cardiology, diabetes, gastroenterology and adult immunisation with plans to cover more specialities in the future.   The recommendations introduced by the API offer in-depth information that can equip healthcare practitioners with the knowledge necessary to adapt medical best practices for teleconsultation. The recommendations encompass patient history, diagnosis, testing, disease management and scheduled follow-ups, thereby enabling practitioners to be cognizant of key parameters for decision-making, guided by flow charts specific to each therapy area.    The recommendations detail technological requirements, software and other practical tips to facilitate consultations. Physicians can thus make optimal use of digital tools, which paves the way for a structured and seamless patient experience.   Furthermore, the recommendations instruct physicians on conditions to rule out various acute conditions, such as myocardial infarctions or arrhythmias, which cannot be managed virtually and may necessitate face-to-face examination or treatment with hospitalisation after an initial teleconsultation. The importance of safety, privacy, and other patient rights and safeguards by familiarising physicians with medicolegal implications, including therapy-specific drug types that can or cannot be prescribed during teleconsultation can be upheld.    Dr S Arul Rhaj, One of the Editor in Chief and Immediate Past President- Association of Physicians of India said, “Telemedicine consultations are now widely sought after, especially with the government’s nod to adopt them for diagnosis and treatment. While general guidelines exist, there is a need for clear-cut and defined guidelines for specific therapy areas, which can vary significantly across symptomology, pathophysiology, diagnosis, testing, disease management and treatment steps and red flags. This necessitated therapy-specific teleconsultation recommendations to ensure structured, streamlined consultations and improved patient care.”    Dr Balagopal Nair, Regional Medical Director, Abbott Pharmaceuticals Division, India said, “Teleconsultation offers the possibility of overcoming geographic restrictions by increasing access and ensuring extensive reach. It has the potential to enhance the efficiency of healthcare systems by offering virtual care and making healthcare more accessible. Abbott has collaborated with the Association of Physicians in India (API) to release the first India-specific teleconsultation guidelines, to provide a useful repository of evidence-based information to healthcare practitioners across different therapeutic areas to appropriately diagnose, treat and manage patient conditions virtually, thereby enabling them to live healthier, fuller lives.”  ]]> https://biospectrumindia.com/news/22/18969/ficci-with-novartis-nasco-and-gascdo-host-2nd-national-sickle-conclave-.html https://biospectrumindia.com/news/22/18969/ficci-with-novartis-nasco-and-gascdo-host-2nd-national-sickle-conclave-.html Mon, 21 Jun 2021 10:35:00 +0530 FICCI, in collaboration with Novartis, National Alliance of Sickle Cell Organizations (NASCO) and Global Alliance of Sickle Cell Disease Organizations (GASCDO), recently held the 2nd National Sickle Cell Conclave on the occasion of World Sickle Cell Day. The conclave, aimed at raising awareness of the need to combat Sickle Cell Disease.    The 2nd National Sickle Cell Conclave was convened with the hope of spearheading a vital discussion on SCD in this evolving landscape and the way forward for the same. The event was graced by speakers including Brig Dr Arvind Lal, Chair – FICCI Swasth Bharat Task Force and Executive Chairman, Dr Lal Pathlabs and Naval Jit Kapoor, Joint Secretary, MOTA, GoI who outlined a roadmap for India, discussing new SCD guidelines report currently underway that will be jointly issued by MOTA and the Ministry of Health and Family Welfare. He also emphasised the key role of public-private collaborations to scale impact and benefit patients.   Speakers also included Dr Aparup Das, Director, ICMR-NIRTH Jabalpur and Dr Anurag Agrawal, Director, CSIR-Institute of Genomics and Integrative Biology, who discussed diagnostic and therapeutic advancements with CRISPR technology. Dr Shailendra Hegde, Senior Vice President, Piramal Swasthya also introduced the ‘Unmukt’ project, with Arjun Munda, Union Minister for Ministry of Tribal Affairs (MOTA), GoI and Renuka Singh Saruta, Minister of State, MOTA, GoI, by flagging off the mobile vans for SCD screening and giving a keynote address.    Kevin Zou, Head of Oncology, Asia Pacific Cluster, Novartis and Anil Kumar Jha, Secretary, MOTA, GoI, also addressed the conclave. A poignant video message addressing the challenge of SCD from Mary Ampomah, President and CEO, GASCDO was also showcased. The event also discussed challenges and recent advancements in SCD management through a panel discussion with health experts in the field, moderated by Vinita Srivastava, Tribal Health Cell, MOTA, GoI and Dr Tulika Seth, Professor Haematology, AIIMS. The panel explored the need to augment awareness, introduce effective preventive, management and novel treatment initiatives with a focus on women and children, including the need to scale neonatal and pregnancy screening.     Arjun Munda commented, “We aim to scale the impact of such efforts, through various collaborations and commitment to disadvantaged communities, including tribal and non-tribal populations. SCD has also been highlighted by the Hon’ble Prime Minister who has identified the need to combat the disease through advances in treatment.”    Saumil Mody, GM, Novartis Oncology India and Member of the National SCD Council said, “Through innovative and digitally-enabled solutions, we hope to meet our dual objectives of empowering our patients through improved SCD screening and access to advanced therapies across the country.”   Novartis has embarked on its latest endeavour towards enabling patient access, facilitating a CSR initiative, ‘Unmukt,’ to send mobile vans across Chhattisgarh and Jharkhand for SCD screening. Novartis has also signed an MoU with Sickle Cell Institute, Raipur to create a centre of excellence and strengthen the public healthcare system’s approach towards SCD.  ]]> https://biospectrumindia.com/news/22/18963/uttar-pradesh-records-less-than-1-per-cent-vaccine-wastage.html https://biospectrumindia.com/news/22/18963/uttar-pradesh-records-less-than-1-per-cent-vaccine-wastage.html Fri, 18 Jun 2021 16:35:00 +0530 Vaccine wastage in Uttar Pradesh has dropped to even less than 1 per cent since the extensive vaccination drive has been started in the state. While many states are complaining about the shortage of vaccines on one hand and allowing substantial stocks to go waste on the other, Uttar Pradesh is working on a war footing to ensure maximum vaccination coverage. In recent data released by the Central Government, states like Jharkhand, Chhattisgarh and Tamil Nadu reported maximum wastage of vaccine doses.   Wastage of both Covishield and Covaxin has been brought down drastically over the past two and a half months to under 1 per cent as per the health department data of 12 June 2021. The consistent efforts made by the state government including increasing the pace of inoculation has resulted in total wastage of vaccine to 0.89 per cent.    Over 36 districts of Uttar Pradesh recorded a negative wastage figure for Covaxin which shows more people are being inoculated than an intended number. Vaccine wastage for Covaxin is merely 0.87 per cent. When it comes to Covishield, the state recorded only 0.92 total wastage of vaccines with as many as 25 districts showing a negative wastage figure.   CM of Uttar Pradesh, Yogi Adityanath has urged repeatedly on bringing down the vaccine wastage to zero in his high-level COVID review meetings with the officials. The UP CM has already directed the officials to plan for the scaling up of vaccination coverage through available stocks and anticipated supplies.   The state is clocking around 4 lakh vaccinations a day and planning to vaccinate around 10 lakh people from July onwards. In the last 24 hours, more than 4,04,192 people got their doses of the vaccine. The CM has asked the officials to accelerate the vaccination campaign.    “The target is to vaccinate 10 crore people by the end of August. There is a need to intensify the vaccination campaign. For this purpose, new vaccinators must be trained” directed the CM while addressing a high-level COVID review meeting.   So far, Uttar Pradesh has administered a total of 2.46 crore vaccine doses. Of which, as many as 2,07,28,945 are first doses and 39,48,835 are the number of second doses. ]]> https://biospectrumindia.com/news/22/18950/venus-remedies-wins-legal-battle-against-french-firm-over-intravenous-paracetamol-patent.html https://biospectrumindia.com/news/22/18950/venus-remedies-wins-legal-battle-against-french-firm-over-intravenous-paracetamol-patent.html Thu, 17 Jun 2021 13:05:00 +0530 Venus Remedies won a 10-year long legal battle that challenged patent claimed by French pharmaceutical firm SCR Pharmatop for producing the intravenous paracetamol solution in India.   In a decision dated June 4, 2021, the Indian Patent Office decided in favour of Venus Remedies and upheld its decision for revocation of the Indian patent because the process lacked any inventive step that made it superior to other existing solutions.    Venus’ opposition was intended to remove any Indian patent hurdle in manufacturing intravenous paracetamol solution in India. As intravenous paracetamol plays a critical role in managing inflammation and fever, hence the revocation of this patent is an encouraging development for the healthcare sector in the country reeling under the current pandemic.   Sharing the development with the key stakeholders of the company, Saransh Chaudhary, President, Global Critical Care, Venus Remedies said, “We are committed to finding and developing the best solutions for global health challenges the biggest part of which is bridging the gap between people and robust healthcare facilities. Our endeavour here was to make sure that critical drugs such as intravenous paracetamol are available in our country to be manufactured generically and accessible at economical prices for the general public, particularly during these difficult times.”   VRL filed the post-grant opposition against the SCR Pharmatop’s intravenous paracetamol patent back in 2011 before Indian Patent Office on several grounds such as lack of novelty and lack of inventive steps, among others. During the case, Patent Office first revoked the patent in 2018 observing that the claims made by SCR Pharmatop are obvious to an ordinary person skilled in the art, however, the company moved their plea to Delhi High Court and Intellectual Property Appellate Board (IPAB).    IPAB directed the Patent Office to again hear the matter and after hearing and written submissions from both parties the Indian Patent Office gave its final decision on June 4, 2021, maintaining the revocation order of Patent no.238164, dated December 24 2018. ]]> https://biospectrumindia.com/news/22/18924/mohfws-virtual-workshop-on-cgmp-for-indian-pharma-industry-held-.html https://biospectrumindia.com/news/22/18924/mohfws-virtual-workshop-on-cgmp-for-indian-pharma-industry-held-.html Tue, 15 Jun 2021 16:45:00 +0530 The third of a series of six virtual workshops on Current Good Manufacturing Practices to support the Indian pharmaceutical industry’s vision of providing world-class quality medical products was inaugurated by Dr Mandeep Bhandari, Joint Secretary, Ministry of Health & Family Welfare, Government of India. The third workshop has 125 participants from 40 pharma units.    Union Ministry of Health & Family Welfare (MoH&FW) collaborated with the World Health Organization (WHO), JSS Academy of Higher Education & Research at Mysuru (JSS AHER), and the Indian Pharmaceutical Alliance (IPA).    In his inaugural address, Dr Bhandari, MoH&FW said, “This initiative of establishing robust learning and training platform meets the critical need of enabling further up-gradation of the pharmaceutical sector for global standards of quality. This will have a far-reaching positive impact."   Welcoming the capacity-strengthening workshops, Dr VG Somani, Drug Controller General of India, said, “We are committed to the highest regulatory standards to ensure quality, safety and efficacy of medical products. It is our constant endeavour that our standards are at par with the best in the world.”    Speaking on the occasion, the WHO representatives from HQ, WHO Regional Office for South-East Asia, and WHO Country Office for India said, “It is for the first time anywhere in the world that we have attempted a programme like this. At the heart of these workshops is the underlying philosophy behind the current Good Manufacturing Practice (cGMP) - ensuring that products are consistently produced and controlled according to quality standards."   The genesis of these workshops is a survey of the pharma sector in India by WHO in 2014, which had recommended further strengthening of the cGMP with the support of WHO.    “The virtual workshops on cGMP is a key step in that direction, and we are delighted to partner in this path-breaking program,” said Sudarshan Jain, Secretary-General, Indian Pharmaceutical Alliance.   Shirish Belapure, Senior Technical Advisor, Indian Pharmaceutical Alliance, said, “IPA Quality forum has one prime objective of upgrading the quality of Indian pharma and these workshops meet the need. IPA fully supports this initiative.”   National and international experts, including from WHO (HQ, Regional Office for South-East Asia, Country Office for India) and leading industry voices came together to design a need-based workshop programme. This was followed by a successful pilot workshop on cGMP for pharmaceutical units in December 2020 on a unique and dedicated WHO-JSS AHER web portal.    “It is a privilege for us to have anchored this initiative. We are grateful to the health ministry, WHO and partners for the faith reposed in us,” said Dr Surinder Singh, Vice-Chancellor, JSS AHER. To ensure long-term impact, a mentor will be guiding the participants for an informed understanding and implementation of WHO cGMP, prequalification guidelines and other world-class quality standards. Importantly, the workshops are also contributing to the larger developmental agenda of health for all.    Dr B Suresh, Pro-Chancellor, JSS AHER said, “The workshops are an important step for enabling the enhancement of pharma standards and contributing to global agendas, including the 2030 Agenda for Sustainable Development. We are delighted to be part of this process.”   Under this initiative, a total of six workshops are being conducted - two for formulation manufacturing pharma units, three for active pharmaceutical ingredients (APIs) manufacturing units, and one for medical devices and IVD manufacturers. Cumulatively, over 650 plus participants from over 185 units will take part in this capacity-strengthening programme.    ]]> https://biospectrumindia.com/news/22/18918/oppi-along-with-health-associations-announce-campaign-to-support-govt-initiatives-on-covid-19.html https://biospectrumindia.com/news/22/18918/oppi-along-with-health-associations-announce-campaign-to-support-govt-initiatives-on-covid-19.html Mon, 14 Jun 2021 21:15:00 +0530 As India continues to battle the scourge of the second wave of the COVID19 pandemic, the Organisation of Pharmaceutical Producers of India (OPPI) has along with International Alliance Of Patients' Organizations (IAPO), Healthcare Federation of India (NATHEALTH), The Indian Pharmaceutical Association (IPA) and SEARPharm Forum (A Forum of FIP & WHO with National Pharmaceutical Association of the South-East Asian Region (SEAR) ) joined hands to support central and state government efforts to ensure dissemination of correct information about COVID-19 and encourage people to get vaccinated.   As a first step, this multi-stakeholder partnership has launched the campaign No One is Safe until Everyone is Safe, which will immediately start disseminating verified information about COVID-19 and encourage people to get their vaccine doses at the earliest.   The key objective of the campaign is to increase awareness and educate citizens through factual, real-time data, to weed out miscommunication and bust numerous myths and incorrect information which are causing confusion and exposing more people to danger. While we believe that this is critical during the second wave of the pandemic, the resources developed in this period will remain relevant and valid for any impending future waves.    This collaborative campaign focuses on four key areas: Individual responsibility; Responsibility towards community; Role of healthcare ecosystem and encouraging vaccination.   The campaign will be followed by a virtual knowledge series to share high-quality educative content on COVID-19 and related issues. Spanning from busting some of the often used myths related to the pandemic to covering emerging global trends, the path to economic recovery and the importance of industry collaborations during COVID-19 and beyond, the series aims at increasing public awareness on the pandemic and the way forward as discussed by leaders from the industry, medical community and academia. The first of the series will start on June 18 and will extend to the end of August.    The industry associations acknowledge the considerable challenges faced by Central and state governments to urgently address the enormous strain the pandemic is placing on healthcare systems, societies and economies. Our collective membership remains committed to sharing our knowledge with regulatory authorities, public health experts and academics to assist with evidence-based decision making.    ]]> https://biospectrumindia.com/news/22/18905/prices-of-oxygen-concentrators-come-down-upto-54.html https://biospectrumindia.com/news/22/18905/prices-of-oxygen-concentrators-come-down-upto-54.html Fri, 11 Jun 2021 16:00:00 +0530 National Pharmaceutical Pricing Authority (NPPA) vide notification dated 3rdJune 2021 has capped the Trade Margin for Oxygen Concentrators at 70% on Price to Distributor (PTD) level. Pursuant thereto, a total of 104 manufacturers / importers of Oxygen Concentrators have submitted revised MRP for 252 products/brands. Downward revision in price up to of 54% has been reported in 70 products/brands, showing reduction in MRP up to Rs. 54,337 per unit. Further, 58 brands have reported price reduction up to 25% and 11 brands between 26-50%. Out of 252 products/brands reported, 18 products/brands reported by the domestic manufacturers did not show any decline in prices. Thus, Trade Margin Rationalisation (TMR) for Oxygen Concentrators has resulted in ensuring consumer savings by eliminating unreasonable profit margins in imported products. Maximum reduction in MRPs have been observed in the following categories: Portable-5LPM (19 out of 80 products) Portable-10LPM (7 out of 32 products) Stationary-5LPM (19 out of 46 products) Stationary-10LPM (13 out of 27 products)   The revised MRP effective from 9th June 2021 on all the brands and specifications have been shared with the State Drug Controllers for strict monitoring and enforcement. In order to monitor availability, the manufacturers / importers of Oxygen Concentrators have been directed to submit monthly stock details.   (LPM- Litre per minute) ]]> https://biospectrumindia.com/news/22/18892/114-bedded-covid-care-facility-opens-in-bhilai-steel-plant-.html https://biospectrumindia.com/news/22/18892/114-bedded-covid-care-facility-opens-in-bhilai-steel-plant-.html Fri, 11 Jun 2021 11:05:00 +0530 Union Minister of Petroleum and Natural Gas & Steel Dharmendra Pradhan virtually inaugurated a 114-bedded covid care facility in Bhilai Steel Plant (BSP) of SAIL in Chhattisgarh. This hospital is equipped with gaseous oxygen and has been set up after laying a pipeline of 1.5 Km for the supply of gaseous oxygen from the plant. This is the first phase of this project which aims to scale up to reach a total of 500 oxygenated beds in the subsequent two more phases. The centre has a facility of double oxygen backup supply. Apart from gaseous oxygen as the main source, there is also a provision of backup of stored liquid medical oxygen. The facility is also equipped with necessary Internet and telecom services to facilitate IT requirements and remote consultancy.SAIL-Bhilai Steel Plant’s JLN Hospital & Research Centre has played an important role in treating COVID patients of the region. As many as 8000 covid patients have been treated in this hospital in Bhilai so far. With the recent rise in the number of patients, the number of beds with oxygen facility has been increased to 594, including 560 beds with piped oxygen supply. Besides in-patient treatment, around 31,000 persons have been tested for covid at four centres including one inside the Plant. A special flu clinic was set up where more than 35,000 covid-suspect persons were given medical guidance. ]]> https://biospectrumindia.com/news/22/18867/health-ministry-orders-44-cr-doses-of-covid-19-vaccines-till-dec-21.html https://biospectrumindia.com/news/22/18867/health-ministry-orders-44-cr-doses-of-covid-19-vaccines-till-dec-21.html Tue, 08 Jun 2021 16:00:00 +0530 The government of India has been supporting the efforts of States and UTs for an effective Vaccination drive under the ‘Whole of Government” approach since 16th January this year. Based on the various representations received by the Union Government, the vaccination for all adults above 18 years of age was opened with the onset of Liberalized Phase III of India’s vaccination strategy on 1st May, 2021. Now with the aim to further universalize the countrywide vaccination drive, all citizens above 18 years of age can receive the COVID1-9 vaccine doses free of cost at Government health facilities. In immediate follow-up of the Prime Minister's announcement of these changes in the Guidelines of National COVID Vaccination program yesterday, the Union Health Ministry has placed an order with Serum Institute of India for 25 crore doses of Covishield and with Bharat Biotech for 19 crore doses of Covaxin. These 44 crore (25+19 cr) doses of COVID-19 vaccines will be available till December 2021, starting now. Additionally, 30% of the advance for procurement of both the Covid Vaccines has been released to Serum Institute of India and Bharat Biotech. ]]> https://biospectrumindia.com/news/22/18845/govt-caps-trade-margin-on-oxygen-concentrators-at-70.html https://biospectrumindia.com/news/22/18845/govt-caps-trade-margin-on-oxygen-concentrators-at-70.html Fri, 04 Jun 2021 20:20:00 +0530 The government has decided to step-in to regulate the price of oxygen concentrators due to the recent volatility in maximum retail prices (MRP). As per information collected by the government, margin at the level of distributor currently ranges up to 198 per cent. By invoking extraordinary powers under Para 19 of the DPCO, 2013 in larger public interest NPPA has capped the trade margin up to 70 per cent on Price to Distributor (PTD) level on oxygen concentrators. Earlier, in February 2019, NPPA had successfully capped the trade margin on anti-cancer drugs. Based on the notified trade margin, NPPA has instructed the manufacturers / importers to report revised MRP within three days. Revised MRPs will be informed in public domain within a week by NPPA. Every retailer, dealer, hospital and institution shall display price list as furnished by the manufacturer, on a conspicuous part of the business premises in a manner to be easily accessible to any person wishing to consult the same. The manufacturers / importers not complying with the revised MRP after trade margin capping, shall be liable to deposit the overcharged amount along with interest @15 per cent and penalty up to 100 per cent under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955. State Drug Controllers (SDCs) shall monitor the compliance of the order to ensure that no manufacturer, distributer, retailer shall sell oxygen concentrators to any consumer at a price exceeding the revised MRP, to prevent instances of black-marketing. The Order shall be applicable up to November 30, 2021, subject to review. Pavan Choudary, Chairman, MTaI, said “We are pleased to note the policy consistency in this move of NPPA to bring oxygen concentrators under Trade margin rationalization (TMR). It was unfortunate to see MRPs of these lifesaving devices skyrocketing as patients gasped for oxygen. This move will build on the success of TMR which was brought for cancer drugs and saved more than Rs 980 crores.” Choudary added, “Though it is not fully in line with what MTaI has proposed because medical devices need greater margins, still it is a step in the right direction and it will provide reasonable margin for players who bear the cost of innovation, fluctuations of raw materials, logistics cost and even fluctuations in training and after sales service cost as witnessed recently, while at the same time usher in affordability for patients. The averaging out of machines given as free patient aids is another concern.”  ]]> https://biospectrumindia.com/news/22/18837/bayer-consumer-health-division-ficci-conference-promote-responsible-self-care-in-india.html https://biospectrumindia.com/news/22/18837/bayer-consumer-health-division-ficci-conference-promote-responsible-self-care-in-india.html Fri, 04 Jun 2021 11:40:00 +0530 Bayer Consumer Health Division, along with The Federation of Indian Chambers of Commerce & Industry (FICCI), convened the ‘Self-care for a Self-reliant India’ conference. The event was graced by key industry representatives and consumer health experts, fostering a discussion on everyday consumer health solutions and the important role they will continue to play in the current pandemic and beyond. The ‘Self-care for a Self-reliant India’ conference, through panel discussions with eminent speakers including Sandeep Verma, Country Head, Bayer Consumer Health Division, India, Manjari Gharat, Academician & President, Indian Pharmaceutical Association, Dr Avula Laxman, Senior Deputy Director, Indian Council of Medical Research and Dr VG Somani, Drugs Controller General of India, Central Drugs Standard Control Organisation examined the current landscape of self-care in India and the need to accelerate the adoption of responsible self-care practices in the country. Over a fireside chat, NK Ahuja, Drugs Controller, Haryana and Arun Mishra, FICCI OTC Task Force elaborated on the direction in which regulatory change and a well-developed framework are needed for a comprehensive OTC policy to build a sustainable consumer health sector, setting the foundation for Aatmanirbharta in self-care.  Addressing the conference, Dr VG Somani, Drug Controller General (India), Ministry of Health & Family Welfare, Government of India said that while there are predictions of a third wave hitting the country, there have been continuous efforts to find newer solutions. "By raising health awareness and putting in place well-defined regulations, consumers can be empowered to take proactive measures to manage minor ailments while also undertaking preventive action to boost immunity, thus reducing the need for healthcare practitioner interventions,” he said. Sandeep Verma, Country Head, Bayer Consumer Health Division – India commented, “Bayer Consumer Health is committed to working collaboratively with stakeholders through the country’s first Self-Care Council to enable responsible self-care in India, driving forward our vision of ‘Health for All, Hunger for None.’”  Dilip Chenoy, Secretary-General, Federation of Indian Chambers of Commerce & Industry (FICCI) said, “We aim to encourage responsible health decisions amongst consumers and the need for accessible consumer health in the country. During these unprecedented times, self-care solutions are needed more than ever, towards positive change and better health outcomes for all.”   ]]> https://biospectrumindia.com/news/22/18836/ministry-of-ayush-organises-webinar-on-traditional-medicinal-products-of-brics-nations.html https://biospectrumindia.com/news/22/18836/ministry-of-ayush-organises-webinar-on-traditional-medicinal-products-of-brics-nations.html Fri, 04 Jun 2021 11:00:00 +0530 Ministry of AYUSH recently organised a webinar on Harmonization of Regulation of Standardization of Traditional Medicinal Products of Brics Countries under India’s BRICS Chairship of 2021. The event was attended by experts and stakeholders from the field of traditional medicine from India, China, South Africa, Russia and Brazil.  Ministry of AYUSH had proposed to organise the said webinar during the First meeting of BRICS Sherpas held on February 24-26, 2021 as a part of India’s Chairship of BRICS 2021 which was agreed by the Member States. Ministry of AYUSH had also hosted the virtual meeting of the BRICS Experts in Traditional Medicines March 25, 2021. AYUSH regulations and pharmacopoeial standards; Pharmacopoeia of Indian Traditional systems of Medicine - An overview and Standardization and Regulation of AYUSH Healthcare Services were presented by India during the webinar. During the second session of the webinar, discussions were held among the industry stakeholders from the field of Traditional Medicine from BRICS Countries. Comprehensive presentations were made by the representatives of the traditional medicine industry from India and China. Dr Manoj Nesari, Adviser (AYUSH), Ministry of AYUSH, Government of India chaired the event and delivered opening remarks. While briefing about the webinar, Dr Nesari emphasised India’s BRICS 2021 priorities and deliverables in the field of traditional medicine to enhance and strengthen BRICS collaboration. The proposal from India included MoU on BRICS Cooperation in Traditional Medicines and the constitution of the BRICS Forum on Traditional Medicine (BFTM). He underlined the need for harmonisation of regulation of standardisation of traditional medicinal products amongst BRICS countries. Initiatives taken by India for the mitigation of COVID-19 through the AYUSH system of medicine were also highlighted upon. During the first session of the webinar, country presentations were made by the representative of BRICS countries on drug regulations; service standards and regulations; pharmacopoeia of traditional medicine in their respective countries.  The experts and stakeholders of traditional medicine from the BRICS countries expressed their appreciation and extended cooperation and support for India’s efforts and initiatives taken for the promotion of Traditional Medicine globally including for BRICS countries. ]]> https://biospectrumindia.com/news/22/18828/adequate-vaccine-will-be-available-from-august-onwards-amitabh-kant-ceo-niti-aayog.html https://biospectrumindia.com/news/22/18828/adequate-vaccine-will-be-available-from-august-onwards-amitabh-kant-ceo-niti-aayog.html Thu, 03 Jun 2021 11:45:00 +0530 Amitabh Kant, CEO, NITI Aayog said that the second wave has been more catastrophic than the first one and it overwhelmed the health system for a while. Kant was addressing the virtual ‘Interactive session on Saving Lives and Livelihood’, organised by FICCI, jointly with OYO. The government has taken a series of measures since then and there has been a steady decline in the number of active cases. “There has been further ramping up of the vaccination drive and the private sector has played a very pivotal role in managing the pandemic and has complemented the efforts of the government in a significant way,” he added. Kant opined, “There may be a slight demand-supply imbalance in vaccination during June-July but from August onwards there will be an adequate amount of vaccines available. From then on, we should be able to vaccinate everybody in India properly and that should help us,” he added. Kant further said, “We need to build up both hospital infrastructure and human resources. We need to ensure ICU facility at the grass-root level. This is also an opportunity for the private sector to come forward,” he added. He emphasised the need to build up a model of private public-partnership in which government acts as a facilitator and the private sector comes forward.  Dilip Chenoy, Secretary-General, FICCI said, “FICCI will continue to support the initiatives of supporting the livelihoods of those associated with travel, tourism and hospitality industry.”   ]]> https://biospectrumindia.com/news/22/18814/health-minister-launches-digitized-versions-of-health-schemes-on-nhas-it-platform.html https://biospectrumindia.com/news/22/18814/health-minister-launches-digitized-versions-of-health-schemes-on-nhas-it-platform.html Wed, 02 Jun 2021 09:45:00 +0530 Dr Harsh Vardhan, Union Minister of Health and Family Welfare has launched the revamped Central Government Health Scheme (CGHS) and the Umbrella schemes of Rashtriya Arogya Nidhi (RAN) and Health Minister’s Discretionary Grant (HMDG) on National Health Authority (NHA)’s IT platform. “Just like the Technological interventions in opening bank accounts, Public Financial Management System (PFMS), subsidies through Direct Benefit Transfer (DBT), Ayushman Bharat scheme for paperless treatment of patients, today’s initiative of convergence of CGHS, RAN and HMDG with NHA platform is also designed to with the vision of making the healthcare services available transparently and swiftly to the needy citizens”, he said. The Union Health Minister remarked that the CGHS, a comprehensive Health Scheme for Serving Employees, Pensioners, Members of Parliament, ex-MPs, etc., and their dependent family members, during last 7 years has expanded to 72 Cities with more than 38 lakh beneficiaries are covered under the scheme.  Dr. Harsh Vardhan noted that e-referral module developed by the National Informatics Centre (NIC) has enabled CGHS dispensaries and wellness centres to issue online referral to empanelled hospitals. The hospital’s processing of application, submission of claims, CGHS team’s sanctioning, release of payment would be done online on the platform henceforth. He also informed that under RAN, financial assistance up to Rs 15 lakhs is provided to poor patients suffering from major life-threatening diseases/cancer/rare diseases, for medical treatment at Government hospitals. The eligibility criteria to avail services under RAN had been based on State/UT-wise BPL threshold.   ]]> https://biospectrumindia.com/news/22/18812/pli-scheme-now-open-for-applications-to-pharma-industry.html https://biospectrumindia.com/news/22/18812/pli-scheme-now-open-for-applications-to-pharma-industry.html Tue, 01 Jun 2021 17:00:00 +0530 Based on a series of consultations with pharmaceutical industry and stakeholders in the Government, the operational guidelines for the Production Linked Incentive (PLI) scheme have been prepared and issued on 1st June. The scheme is now open to applications from the industry. The applications are invited in three groups based on the Global Manufacturing Revenue of FY 2019-20 of the applicants. A special carve out for MSMEs has been kept under the scheme. All the applications will be submitted through an online portal maintained by SIDBI, the Project Management Agency for the scheme. Application can be made on the online portal, URL of which is https://pli-pharma.udyamimitra.in.  The application window is for 60 days staring from 2nd June, 2021 to 31st July, 2021 (Both dates inclusive). The eligible products have been categorized into three categories. The products covered under the scheme are formulations, biopharmaceuticals, active pharmaceutical ingredients, key starting material, drug intermediates, in-vitro diagnostic medical devices, etc. The category-1 and category-2 products attract 10% incentive and category-3 products attract 5% incentive on the incremental sales. Incremental sales of a product mean sales of that product in a year over and above the sales of that product in FY 2019-2020. Based on clearly laid out selection criteria given in the guidelines, a maximum of 55 applicants will be selected under the scheme. An applicant, through a single application, can apply for more than one product and the products applied by an applicant can be in any of the three categories.  A selected participant will be able to get a maximum incentive of Rs 1000 crore, Rs 250 crore and Rs 50 crore respectively depending upon its group over the period of the scheme.  ]]> https://biospectrumindia.com/news/22/18803/who-vital-strategies-launch-anti-tobacco-campaign.html https://biospectrumindia.com/news/22/18803/who-vital-strategies-launch-anti-tobacco-campaign.html Tue, 01 Jun 2021 10:55:00 +0530 Global health organisation Vital Strategies and the World Health Organization (WHO) has launched a national mass media campaign to encourage tobacco users to quit. The campaign, 'When You Quit' explains how smoking cigarettes or bidi can cause heart attack and may also increase the risk of severe COVID-19. The public service announcement (PSA) also depicts the health benefits tobacco users experience when they quit . The PSA aligns with this year’s World No Tobacco Day theme 'Commit to Quit' and urges people to quit tobacco using the National Tobacco Quitline (1800-11-2356) for resources and help. WHO is supporting the “When You Quit” campaign developed in multiple Indian languages and to be aired across 15 states covering 169 districts with a high burden of tobacco use through All India Radio, MY FM & Radio City. Additionally, Vital Strategies will augment the amplification of the message through major online streaming platforms - Facebook, Hotstar, Voot, Zee5, SonyLiv and MX Player. Dr Roderico H Ofrin, WHO Representative to India said, “This year’s theme for WNTD 'Commit to Quit' aims to support 100 million people worldwide in their attempts to give up tobacco through various initiatives. We all must help create healthier environments that are conducive to quitting tobacco use.” Vaishakhi Mallik, Associate Director, Vital Strategies said, “We’re proud to collaborate with the WHO in scaling up the fight against the tobacco epidemic with the Government of India through the launch of this campaign. “When You Quit” comes at a pivotal moment of the pandemic in India as cases continue to surge across the country and people with underlying health conditions remain at an increased risk of severe illness from COVID-19." ]]> https://biospectrumindia.com/news/22/18785/japan-approves-astrazeneca-covid-19-vaccine-vaxzevria-for-emergency-use.html https://biospectrumindia.com/news/22/18785/japan-approves-astrazeneca-covid-19-vaccine-vaxzevria-for-emergency-use.html Fri, 28 May 2021 00:00:00 +0530 AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), formerly AZD1222, has been granted a special approval for emergency use in Japan for active immunisation of individuals aged 18 years and older, to prevent COVID-19 caused by SARS-CoV-2. The Japanese Ministry of Health, Labour and Welfare granted the approval based on positive Phase III efficacy and safety data from the Oxford University-led clinical trial programme in the UK, Brazil and South Africa, and a Phase I/II trial in Japan. Japan’s Pharmaceuticals and Medical Devices Agency recommends that the use of Vaxzevria should be limited to adults and administered intramuscularly as two 0.5 mL doses given four to 12 weeks apart, with an interval greater than eight weeks being preferable to maximise its efficacy. This dosing regimen was shown in clinical trials to be well-tolerated and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.1 Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “We continue to expand global access to our vaccine and today’s approval brings us one step closer to providing Vaxzevria to the people of Japan who urgently need protection from coronavirus. We are proud to have produced a vaccine for the world, which is playing a leading role in the global fight against the pandemic, with more than 400 million doses now supplied by AstraZeneca and sub-licensees to 165 countries.” Production of the vaccine in Japan is already underway, and the first doses are expected to be available in the coming weeks. ]]> https://biospectrumindia.com/news/22/18770/india-proposes-brics-consortium-to-tackle-ncds-as-flagship-programme.html https://biospectrumindia.com/news/22/18770/india-proposes-brics-consortium-to-tackle-ncds-as-flagship-programme.html Thu, 27 May 2021 17:00:00 +0530 Experts deliberated on emerging issues in the various fields of Biotechnology and Biomedicine at the fourth BRICS Working Group meeting on the subject area. BRICS is the acronym coined to associate five major emerging economies: Brazil, Russia, India, China, and South Africa. More than 60 participants, including researchers, academicians, and government officials participated in the online meeting organized from May 25 to May 26 2021. The members of the working group on Biotechnology and Biomedicine suggested future directions of research collaboration among BRICs countries in the areas such as Antimicrobial Resistance, Artificial Intelligence and Digital Health Medicine, Non-Communicable Diseases, Neurological Disorders, Agro-biotechnology, Food and Nutrition, Cancer, long Post-Covid Challenges and Complications including Molecular Pathogenesis of COVID-19 virus. The meeting was sponsored by, Department of International Cooperation, Ministry of Science and Technology (MOST), China and was organized by the China National Center for Biotechnology Development. From Indian side, key scientific institutions that participated include Department of Science and Technology (DST), Department of Biotechnology (DBT), Indian Institute of Technology Delhi, All India Institute of Medical Sciences New Delhi, Indian Institute of Technology, Jodhpur, India, Banaras Hindu University, Delhi University. India proposed BRICS Consortium to address Post Covid challenges, tackling Non-Communicable Diseases as Flagship Programme whereas Russia proposed Sustainable Agro-biotechnology for Healthy Food & Nutrition, advanced Virtual Reality assisted technology for neurorehabilitation. China proposed Cancer research as Flagship Programme. ]]> https://biospectrumindia.com/news/22/18765/govt-of-karnataka-partners-with-cac-to-track-covid-through-waste-water-surveillance.html https://biospectrumindia.com/news/22/18765/govt-of-karnataka-partners-with-cac-to-track-covid-through-waste-water-surveillance.html Thu, 27 May 2021 14:45:00 +0530 Government of Karnataka is introducing a city-wide sewage surveillance system in Bangalore that will help officials track the virus at an early stage, even among asymptomatic individuals.  Assisting this effort is the United States Agency for International Development (USAID) and the Skoll Foundation-supported COVIDActionCollab (CAC), an India-wide collaborative of over 300 organisations and networks working together to provide COVID-19 relief and recovery services to the country’s most vulnerable communities.  The Precision Health Platform in Bengaluru, the first-of-its-kind in Asia, will test sewage from both the sewered and non-sewer wastewater to identify clusters of new infections. Early identification of clusters can help guide the COVID-19 response and give policymakers the information they need to better allocate limited pandemic resources. CAC supports the Government of Karnataka by providing training for sanitation workers and lab technicians on collecting and transporting sewage samples to labs for testing and analysing and safely disposing of them. The Technical Expert Group will provide programmatic inputs and insights to policymakers for targeted COVID-19 prevention, care, and management services based on the analysis. Government of Karnataka plans to begin testing across 45 wards in Bangalore. Rakesh Singh, Additional Chief Secretary, Urban Development says, “The system will cover over 75 per cent of Bengaluru’s nine million population by generating over 90 data points per week signalling the emerging COVID-19 clusters or signalling a COVID-19 cluster’s exit from an area. We are happy to be the first in India to launch this platform.” Although sewage testing is not a replacement for clinical testing and citizens are advised to continue following safety guidelines, this surveillance system is a cost-effective tool that can be used not only for COVID-19 but in the future, it can also track other pathogens with pandemic potential and measure antimicrobial resistance in the population. Dr Angela Chaudhuri, Health Lead, CAC, says, “While there have been many experiments and studies on finding traces of the COVID-19 virus in sewage, Bengaluru will be joining the Netherlands, Finland, and Israel in path-breaking surveillance system like this with experts from all over the world supporting the initiative.” Sangita Patel, Director, USAID/India Health Office, said, “Since the beginning of the pandemic, the US and India have worked closely together to provide life-saving treatments, disseminate public health messages to local communities; strengthen case-finding and surveillance; and support innovative solutions to bolster emergency response and preparedness. USAID is proud to support COVIDActionCollab and these efforts to identify early clusters of the virus for better pandemic preparedness and management. We hope success in Karnataka will lead to the expansion of similar systems in other locations across India." Lucien Chan, MD, Skoll Foundation, said, “As part of our mission to support different regions through the pandemic, we realised the need for an efficient and cost-effective mechanism for tracking the outbreak in these regions. The Precision Public Health Surveillance approach developed by the CAC will greatly support governments in monitoring the spread of the virus and allow them to take preventive measures rather than reacting after the crisis has occurred. The programme holds immense potential, and I look forward to seeing other governments consider this approach in their respective states." ]]> https://biospectrumindia.com/news/22/18751/aimed-opposes-gst-exemption-on-medical-devices.html https://biospectrumindia.com/news/22/18751/aimed-opposes-gst-exemption-on-medical-devices.html Wed, 26 May 2021 17:55:00 +0530 The Association of Indian Medical Device Industry (AiMeD) has opposed GST exemption on Medical Devices as it is counterproductive and anti Make in India. Rajiv Nath, Forum Coordinator, AiMeD, wrote a letter to Nirmala Sitharaman, Chairperson, GST Council of India and Minister of Finance requesting that Medical Devices used for COVID-19 prevention and treatment like hand sanitisers, face masks, PPE Kits, oximeters, ventilators, etc. should not be fully exempted from GST levy. According to Nath, the cost of manufacturing of the items will be increased to the extent of any GST (Input Tax) paid on purchases of the raw materials and services for the furtherance of the business, as Input Tax Credit (ITC) is not available against exempted supplies and makes the domestic product more expensive and less competitive against imports. Nath added, "For 40 medical devices listed having the GST rate of 18 per cent (e.g. Thermometers, hot water bottles, laboratory instruments)needs to be reduced to 12 per cent as these are not luxury goods but needed for healthcare. However, we at AiMeD are opposed to a call by importers and healthcare providers lobby seeking full exemption of GST for Covid related Medical Devices. It is counterproductive and anti-Make in India as it reduces the global competitiveness of Indian manufactured medical devices. Indian manufacturers will need to increase ex-factory prices as they would be unable to set off their GST paid on their input procurement to their outputs sales. Imports on other hand would become 12 per cent cheaper. Historically, no importers had provided evidence that they reduced the MRP when GST or Excise Duty as earlier on their products was reduced." Nath further emphasised that medical devices are 85 per cent import-dependent even after 73 years of our independence. Due to Atmanirbhar Bharat Abhiyan by our prime minister and subsequent some favourable domestic manufacturing encouragement policies of the government, the domestic manufacturers stepped forward to make India self-reliant on medical devices. The importer's lobby is strongly pushing their agenda of constantly seeking exemption of Custom Duty & GST to reduce their import costs and this has historically discouraged domestic manufacturing and resulted in over-dependence on imports. According to Nath, India imports over Rs 42000 crore worth of medical devices and is already import-dependent due to very low custom import duties only up to 7.5 per cent. He further added, "If tax authorities want to protect consumers interest then capping of MRP to two to three times over import landed CIF price or ex-factory prices for domestic manufacturers would be more impactful rather than reducing GST and result in immediate direct benefits as in many cases the MRP is artificially inflated 10-20 times of import landed price in a skewed market place. The price of such medical devices could fall by over 50 per cent, he claimed." Nath on behalf of the domestic medical devices industry sought favourable support from Sitharaman to end India’s huge import dependency to boost Atmanirbhar Bharat Abhiyan and Make in India initiatives. ]]> https://biospectrumindia.com/news/22/18726/telangana-implements-ayushman-bharat-pm-jay-scheme.html https://biospectrumindia.com/news/22/18726/telangana-implements-ayushman-bharat-pm-jay-scheme.html Tue, 25 May 2021 08:45:00 +0530 The National Health Authority (NHA) has signed an MoU with the Government of Telangana to implement Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) in the state with immediate effect. The Ayushman Bharat scheme has been integrated with the existing state scheme ‘Aarogyasri’ and this converged scheme is being called Ayushman Bharat PM-JAY Aarogyasri. With the launch of Ayushman Bharat PM-JAY in Telangana, the scheme has been further expanded and now encompasses 33 States/UTs. With this convergence, approximately 26 lakhs beneficiary families (around 1.3 crore individuals) as per SECC, 2011 data will be eligible to avail services under the scheme in the state. Speaking on this launch, Dr RS Sharma, CEO, National Health Authority, said, “We are happy to onboard the State of Telangana for the rollout of AB PM-JAY in the state. The beneficiaries from the state are now eligible to avail free healthcare services pan India through our network of more than 22,000 hospitals. This is not only going to benefit the eligible families in the state but will also enable the delivery of healthcare services to PM-JAY beneficiaries from other States/UTs living in Telangana. The providers’ base has also increased. Our call centre has started getting calls from the eligible population in the state. We are committed to taking the benefit of the scheme to all eligible beneficiaries.” While the eligible population of the state would benefit from free healthcare services across the country, the launch of a converged scheme will lead to the effective utilisation of resources for providing quality healthcare services. NHA will provide several auxiliary supports to State Health Agency (SHA) including related to fraud and abuse control. A beneficiary can call the toll-free number 14555 to know about their eligibility under the scheme and information on how to avail the services. ]]> https://biospectrumindia.com/news/22/18704/nidhi4covid2-0-to-assist-startups-for-tackling-second-covid-19-wave.html https://biospectrumindia.com/news/22/18704/nidhi4covid2-0-to-assist-startups-for-tackling-second-covid-19-wave.html Fri, 21 May 2021 14:50:00 +0530 National Science & Technology Entrepreneurship Development Board (NSTEDB), Department of Science & Technology (DST), Government of India (GoI) has launched an initiative NIDHI4COVID2.0, that will fund eligible startups and companies registered in India. The start-ups offer promising solutions in the thrust areas of oxygen innovation, portable solution, relevant medical accessories, diagnostic, informatics, or any other solution that addresses/mitigate various challenges faced by the country/society due to the severe impact of COVID-19. Promising startups will be provided with financial and mentoring support for scaling up their products/technologies to the next level and speeding up their processes, helping them reach the product deployment stage as fast as possible. This initiative has been built based on NSTEDB's experience of implementing Centre for Augmenting WAR with COVID-19 Health Crisis (CAWACH) and also through special calls through National Initiative for Developing and Harnessing Innovations - Seed Support System (NIDHI - SSS) from Technology business incubators (TBI) to support Startups in 2020. “Supporting the development of devices like oxygen concentrators also brings with it huge opportunities in the development and manufacturing of several critical components that are being imported such as specialised valves, zeolite materials, oil-less and noiseless miniaturised compressors, gas sensors, etc. which have wider applications in several sectors,” said Prof Ashutosh Sharma, Secretary, DST. ]]> https://biospectrumindia.com/news/22/18696/tbdcair-canada-ontario-govtsend-covid-relief-materials-to-india.html https://biospectrumindia.com/news/22/18696/tbdcair-canada-ontario-govtsend-covid-relief-materials-to-india.html Thu, 20 May 2021 20:50:00 +0530 Toronto Business Development Centre (TBDC) is supporting COVID relief efforts in collaboration with Air Canada and the Government of Ontario by providing urgent medical supplies to the Indian population which has been severely hit by the COVID-19 pandemic. 3000 ventilators and other medical supplies donated by the Ontario Government to the Indian Red Cross have reached India.  The Toronto Business Development Centre (TBDC) was asked by the Ontario Government to facilitate the shipment of its donation to India.  “We share a strong and deep relationship with India and we stand with the people of India and its frontline workers during these difficult times. India is the world’s largest vaccine manufacturer and has so far shipped over 66 million doses around the globe. We invite the global community to help India fight the pandemic because unless everyone is safe, no one is safe," said Vikram Khurana, Chairman, Toronto Business Development Centre. An Air Canada Boeing 787-9 Dreamliner operated a cargo-only flight with 40 tonnes of essential supplies from Toronto Pearson Airport to New Delhi. The freight included critical medical equipment such as oxygen cylinders, oxygen generators and Personal Protective Equipment (PPE). Air Canada also carried 100 ventilators donated recently by the Saskatchewan Government.  “When flights to India were suspended on April 22, the movement of essential goods between the two countries was also halted. With this exceptional cargo-only flight, we are grateful to help and contribute to these relief efforts by shipping critical medical supplies. We worked closely with the Toronto Business Development Centre and the Government of Ontario to ensure timely support, in solidarity with the affected communities,” said Jason Berry, Vice-President, Cargo at Air Canada. ]]> https://biospectrumindia.com/news/22/18693/singapore-extends-use-of-pfizer-biontech-covid-19-vaccine-to-adolescents.html https://biospectrumindia.com/news/22/18693/singapore-extends-use-of-pfizer-biontech-covid-19-vaccine-to-adolescents.html Thu, 20 May 2021 00:00:00 +0530 The Health Sciences Authority (HSA) at Singapore has extended the authorisation of Pfizer-BioNTech COVID-19 vaccine for use in adolescents of ages 12 to 15 years for the prevention of COVID-19. The vaccination regimen is the same as that for adults, i.e. two doses of the vaccine to be administered 21 days apart. The Pfizer-BioNTech COVID-19 vaccine was granted interim authorisation under the Pandemic Special Access Route (PSAR) for individuals aged 16 years and above in December 2020. At that time, the data in individuals aged below 16 years was not yet available. As a condition for interim authorisation under PSAR, Pfizer and BioNTech were required to continue to study the safety and efficacy of the vaccines in other subgroups and submit the relevant data for HSA’s review. On 13 April 2021, Pfizer and BioNTech submitted an application to extend the vaccination population for the Pfizer-BioNTech COVID-19 vaccine to adolescents aged 12 to 15 years old to HSA. HSA’s review of the clinical data for this subgroup found that the Pfizer-BioNTech COVID-19 vaccine induced a robust immune response and demonstrated a high vaccine efficacy of 100%. This vaccine efficacy was based on the on-going Phase 3 clinical trial, which enrolled over 2,000 participants aged 12 to 15 years. Based on the safety data available from a median follow-up duration of 2 months after vaccination, the overall safety profile of the vaccine in adolescents was comparable to that observed in adults. The side effects include injection site pain, fatigue, headache, chills and fever. They generally resolved on their own within a few days. ]]> https://biospectrumindia.com/news/22/18670/centre-to-provide-more-than-5-cr-vaccine-doses-to-states-for-free-till-15-june.html https://biospectrumindia.com/news/22/18670/centre-to-provide-more-than-5-cr-vaccine-doses-to-states-for-free-till-15-june.html Wed, 19 May 2021 00:00:00 +0530 According to the advance visibility provided by Govt of India to States/UTs, a total of 5 crore 86 lakh and 29 thousand doses will be provided free of cost by Govt of India to States from 1st May 2021 to 15th June 2021. In addition, as per information received from vaccine manufacturers, a total of 4 crore, 87 lakh and 55 thousand doses will also be available till end of June 2021 for direct procurement by States/UTs. In view of the above visibility of vaccines with clear supply timelines till June 2021, and in order to ensure efficient and judicious utilization of available doses for successful implementation of COVID-19 vaccination drive, the States/UTs have been advised the following: To prepare a district-wise, COVID Vaccination Centre (CVC)-wise plan for administration of COVID-19 vaccine. To use multiple media platforms for dissemination of such a plan to enhance awareness among the masses. Both the States Govts & Private CVCs to publish their vaccination calendar on CoWIN digital platform in advance. States & Private CVCs to desist from publishing single day vaccination calendars. To ensure that there is no overcrowding at the CVCs. To ensure that the process of booking appointments on CoWIN is hassle-free. The States and UTs have been advised to direct the concerned officials to prepare advance plan for administration of COVID-19 vaccine till 15th of June 2021. ]]> https://biospectrumindia.com/news/22/18591/dcgi-gives-nod-to-anti-covid-19-drug-made-by-inmas-dr-reddys-labs.html https://biospectrumindia.com/news/22/18591/dcgi-gives-nod-to-anti-covid-19-drug-made-by-inmas-dr-reddys-labs.html Sat, 08 May 2021 00:00:00 +0530 An anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy’s Laboratories (DRL), Hyderabad. Clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients. The drug will be of immense benefit to the people suffering from COVID-19. In April 2020, during the first wave of the pandemic, INMAS-DRDO scientists conducted laboratory experiments with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad and found that this molecule works effectively against SARS-CoV-2 virus and inhibits the viral growth. Based on these results, Drugs Controller General of India’s (DCGI) Central Drugs Standard Control Organization (CDSCO) permitted Phase-II clinical trial of 2-DG in COVID-19 patients in May 2020. The DRDO, along with its industry partner DRL, started the clinical trials to test the safety and efficacy of the drug in COVID-19 patients. In Phase-II trials (including dose ranging) conducted during May to October 2020, the drug was found to be safe in COVID-19 patients and showed significant improvement in their recovery. Phase IIa was conducted in six hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country. Phase-II trial was conducted on 110 patients. The drug comes in powder form in sachet, which is taken orally by dissolving it in water. It accumulates in the virus infected cells and prevents virus growth by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique. ]]> https://biospectrumindia.com/news/22/18580/phd-chamber-urges-govt-to-facilitate-voluntary-licensing-of-covid-19-vaccines-in-india.html https://biospectrumindia.com/news/22/18580/phd-chamber-urges-govt-to-facilitate-voluntary-licensing-of-covid-19-vaccines-in-india.html Thu, 06 May 2021 18:10:00 +0530 As the second wave of COVID-19 has struck with a devastating impact throughout the country, with cases rising continuously, there is an urgent need to ramp up the production of Covaxin and Covishield through voluntary licensing, said Sanjay Aggarwal, President, PHD Chamber of Commerce and Industry. Voluntary Licensing refers to the authorization given by the patent holder to a third party to manufacture and sell the patented product on the basis of mutually agreed terms. "The second wave is spreading faster than the first wave and affecting almost every household in India. At this critical juncture there is a need to urgently provide licensing of production of Covaxin, Covishield and Sputnik. Compulsory Licensing is another way of granting a license by the Government to a third party to use the patent, however, this may not be very useful in the case of  manufacturing of technologically advanced COVID-19 vaccinations. At this juncture, the Government should facilitate and encourage Bharat Biotech, Oxford-Astra Zeneca and RDIF to grant Voluntary Licenses alongwith transfer of technology, even if for a limited period of one year,  for the production of Covaxin, Covishield and Sputnik to more and more pharmaceutical companies in India on mutually accepted terms so as  to maximise the production and supply of vaccines in the country", he added. ]]> https://biospectrumindia.com/news/22/18574/cdsco-approves-roches-antibody-cocktail-to-treat-covid-19.html https://biospectrumindia.com/news/22/18574/cdsco-approves-roches-antibody-cocktail-to-treat-covid-19.html Wed, 05 May 2021 17:00:00 +0530 Roche India has announced that the Central Drugs Standards Control Organisation (CDSCO) has provided an Emergency Use Authorisation (EUA) for Roche’s antibody cocktail (Casirivimab and Imdevimab) in India. This approval was based on the data that have been filed for the EUA in the United States, and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union. This Emergency Use Authorisation will now enable Roche to import the globally manufactured product batches to India and will be marketed as well as distributed in India through a strategic partnership with Cipla Limited. The production process for this biologic medicine is very complex and Roche as one of the largest biologics manufacturers in the world was selected by its partner Regeneron to expand worldwide production capacity. The antibody cocktail (Casirivimab and Imdevimab) is to be administered for the treatment of mild to moderate coronavirus COVID-19 in adults and pediatric patients (12 years of age or older, weighing at least 40 kg) who are confirmed to be infected with SARS-COV2 and who are at high risk of developing severe COVID-19 disease.  "With the increasing number of Covid-19 infections in India, Roche is committed to doing everything we can to minimise hospitalisations and ease pressure on healthcare systems. This is where neutralising antibody cocktails like casirivimab and imdevimab can play a role in the fight against COVID-19 and in treatment of high risk patients before their condition worsens. We are thankful to the CDSCO for granting an EUA for casirivimab and imdevimab. This outpatient treatment for COVID-19 will be complementary to the ongoing vaccination drive and support our fight against the pandemic in India’, said V. Simpson Emmanuel, Managing Director, Roche Pharma India. ]]> https://biospectrumindia.com/news/22/18559/centre-places-fresh-orders-worth-rs-2520-cr-for-covishield-covaxin.html https://biospectrumindia.com/news/22/18559/centre-places-fresh-orders-worth-rs-2520-cr-for-covishield-covaxin.html Mon, 03 May 2021 18:10:00 +0530 The Centre has stated that 100% advance of Rs 1732.50 crore (after TDS Rs. 1699.50 cr) has been released to Serum Institute of India (SII) on 28.04.2021 for 11 crore doses of Covishield vaccine during May, June and July, and was received by them on 28.04.2021. As on date, against the last order of 10 crore doses for supplies of Covishield vaccine, 8.744 crore doses have been delivered till 03.05.2021. SII has endorse this statement, & the authenticity of the information. "We have been working closely with the Government of India for the past year & thank it for its support. We remain committed to ramping up our vaccine production to save every life we can", stated the company on Twitter. Additionally, 100% advance of Rs. 787.50 crore (after TDS Rs. 772.50 cr) was released on 28.04.2021 to Bharat Biotech India Ltd (BBIL) for 5 crore Covaxin doses during May, June and July, and was received by them on 28.04.2021. As on date against the last order of 2 crore doses for supplies of Covaxin vaccine, 0.8813 crore doses have been delivered till 03.05.2021. ]]> https://biospectrumindia.com/news/22/18546/india-begins-import-of-4-5-lakh-vials-of-remdesivir.html https://biospectrumindia.com/news/22/18546/india-begins-import-of-4-5-lakh-vials-of-remdesivir.html Fri, 30 Apr 2021 14:00:00 +0530 The Government of India has started importing the vital drug Remdesivir from other countries to ease out the shortage of Remdesivir in the country.  HLL Lifecare Ltd, a Government of India owned company has ordered 4,50,000 vials of Remdesivir  from Gilead Sciences Inc USA. and Egyptian Pharma Company, Eva Pharma.  It is expected that Gilead Sciences Inc. USA will dispatch 75,000 to 1,00,000 vials. Further one hundred thousand quantities will also be supplied before or by May 15. EVA pharma will supply approximately 10,000 vials initially followed by 50,000 vials every 15 days or till July. Government has ramped up the production capacity of Remdesivir in the country. As on 27.04.21, the production capacity of the seven licensed domestic manufacturers increased from 38 lakh vials per month to 1.03 crore vials per month. Total 13.73 lakh vials have been supplied across the country by the Drug companies in the last seven days (21-28 April, 2021). The daily supply has gone up from 67,900 vials on 11th April to 2.09 lakh vials on 28th April, 2021. An advisory was issued by MHA to states and UTs to facilitate smooth movement of Remdesivir supplies.  Government has also prohibited the export of Remdesivir to enhance its availability in India. To ensure affordability of the injection among the masses, NPPA on April 17, 2021 released the revised maximum retail price thus bringing down the cost of all the major brands to below Rs 3500 per vial. ]]> https://biospectrumindia.com/news/22/18502/dcgi-gives-eua-to-zydus-for-using-virafin-on-covid-19-patients.html https://biospectrumindia.com/news/22/18502/dcgi-gives-eua-to-zydus-for-using-virafin-on-covid-19-patients.html Fri, 23 Apr 2021 00:00:00 +0530 Zydus Cadila ha announced that the company has received Restricted Emergency Use Approval (EUA) from the Drug Controller General of India (DCGI) for the use of ‘Virafin’, Pegylated Interferon alpha-2b (PegIFN) in treating moderate COVID-19 infection in adults. A single dose subcutaneous regimen of the antiviral Virafin will make the treatment more convenient for the patients. When administered early on during COVID, Virafin will help patients recover faster and avoid much of the complications. Virafin will be available on the prescription of medical specialist for use in hospital/institutional setup. In the multicentric trial conducted in 20-25 centers across India, Virafin had shown lesser need for supplemental oxygen, clearly indicating that it was able to control respiratory distress and failure which has been one of the major challenges in treating COVID-19. The drug has also shown efficacy against other viral infections. Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Limited said “The fact that we are able to offer a therapy which significantly reduces viral load when given early on can help in better disease management. It comes at a much-needed time for patients and we will continue to provide them access to critical therapies in this battle against COVID-19.” In its Phase III clinical trials, the therapy had shown better clinical improvement in the patients suffering from COVID-19. During the trials, a higher proportion of patients administered with PegIFN arm were RT PCR negative by day 7. The drug ensures faster viral clearance and has several add-on advantages compared to other anti-viral agents. For the development of Virafin, Zydus appreciated the support provided by  DBT-BIRAC COVID-19 Research Consoritum, for conducting the Phase II human clinical trial studies.  Speaking on this achievement Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, ‘’The government  has been committed to provide all possible facilitation to our industries to work towards mitigation strategies and interventions against COVID-19 pandemic. The emergency nod provided to Virafin is another milestone which is a boon for the medical facility providers.” ]]> https://biospectrumindia.com/news/22/18473/finance-ministry-provides-rs-4500-cr-to-boost-vaccine-production.html https://biospectrumindia.com/news/22/18473/finance-ministry-provides-rs-4500-cr-to-boost-vaccine-production.html Tue, 20 Apr 2021 17:00:00 +0530 The Finance Ministry has approved Rs 3,000 crore for Pune-based Serum Institute of India (SII) for manufacturing the AstraZeneca COVID-19 vaccine Covishield and Rs 1500 crore to Hyderabad-based Bharat Biotech for ramping up the production of Covaxin. Prime Minister Narendra Modi has urged the vaccine manufacturers to continuously scale up the production capacity to vaccinate people in the shortest possible time.  The Government has ensured that all the vaccine manufacturers not only get all possible help and logistic support, but also the process of vaccine approval is speedy and scientific, said the Prime Minister. "On behalf of the vaccine industry in India, I would like to thank and applaud the PM for decisive policy changes and swift financial aid which will help vaccine production and distribution in India", tweeted Adar Poonawalla, CEO, SII. ]]> https://biospectrumindia.com/news/22/18464/govt-allows-vaccination-to-everyone-above-18-from-1st-may-.html https://biospectrumindia.com/news/22/18464/govt-allows-vaccination-to-everyone-above-18-from-1st-may-.html Mon, 19 Apr 2021 21:00:00 +0530 In a meeting chaired by PM Narendra Modi, an important decision of allowing vaccination to everyone above the age of 18 from 1st May has been taken. PM said that the Government has been working hard from over a year to ensure that maximum numbers of Indians are able to get the vaccine in the shortest possible of time. He added that India is vaccinating people at world record pace & we will continue this with even greater momentum. The main elements of the  Liberalised and Accelerated Phase 3 Strategy of the National Covid-19 Vaccination program that would come in effect from 1st May 2021, are as follows:- (i)      Vaccine manufacturers would supply 50% of their monthly Central Drugs Laboratory (CDL) released doses to Govt. of India and would be free to supply the remaining 50% doses to State Govts. and in the open market (hereinafter referred to as other than Govt. of India channel).  (ii)    Manufacturers would transparently make an advance declaration of the price for 50% supply that would be available to State Govts. and in open market, before 1st May 2021. Based on this price, State governments, private hospitals, industrial establishments etc would be able to procure vaccine doses from the manufacturers. Private Hospitals would have to procure their supplies of Covid-19 vaccine exclusively from the 50% supply earmarked for other than Govt. of India channel. Private Vaccination providers shall transparently declare their self-set vaccination price. The eligibility through this channel would be opened up to all adults, i.e. everyone above the age of 18. (iii)    Vaccination shall continue as before in Govt. of India vaccination centres, provided free of cost to the eligible population as defined earlier i.e. Health Care Workers (HCWs), Front Line Workers (FLWs) and all people above 45 years of age.     ]]> https://biospectrumindia.com/news/22/18449/govt-augments-manufacturing-capacity-for-covaxin-production.html https://biospectrumindia.com/news/22/18449/govt-augments-manufacturing-capacity-for-covaxin-production.html Fri, 16 Apr 2021 13:00:00 +0530 As a part government's augmentation plan, capacities of Bharat Biotech Limited, Hyderabad as well as other public sector manufacturers are being upgraded with required infrastructure and technology. Financial support is being provided as grant from GoI to the tune of appx Rs 65 Cr to Bharat Biotech’s new Bangalore facility which is being repurposed to increase the capacity of vaccine production. 3 public sectors companies are also being supported to increase the capacity of vaccine production. The Department of Science & Technology (DST), GoI, has granted approval to Haffkine Institute to produce Bharat Biotech's Covaxin vaccine on a transfer of technology basis.  Last month Maharashtra Chief Minister Uddhav Thackeray in a video conference with the Prime Minister, Narendra Modi had urged the centre to grant permission to Haffkine Bio-Pharmaceutical Corporation Limited to manufacture the COVID-19 vaccine. Financial support as grant from GoI to the tune of appx Rs 65 Cr will be provided for this facility to be made ready for manufacturing.The Haffkine Biopharmaceuticals Ltd had asked for around 12 months to complete this task. However, the Central government has asked them to expedite and complete the task urgently within 6 months. The facility will have a capacity of 20 million dozes per month, once functional. Indian Immunologicals Limited (IIL), Hyderabad –A facility under National Dairy Development Board and Bharat Immunologicals and Biologicals Limited (BIBCOL), Bulandshahr  a CPSE under Department of Biotechnology, Govt of India will also be supported to prepare their facility to provide 10-15 million dozes per month by Aug - Sep 2021.   ]]> https://biospectrumindia.com/news/22/18439/health-ministry-issues-regulatory-steps-to-approve-foreign-made-covid-19-vaccines.html https://biospectrumindia.com/news/22/18439/health-ministry-issues-regulatory-steps-to-approve-foreign-made-covid-19-vaccines.html Thu, 15 Apr 2021 13:00:00 +0530 The Union Health Ministry has issued the Regulatory Pathway in India for COVID-19 Vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL). CDSCO shall prepare detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) recommendations. These guidelines have since been prepared and posted by CDSCO on its website. CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders. Applicants for grant of approval for Restricted Use in Emergency situation may be submitted to CDSCO. Application can be made by the foreign manufacturer through its Indian subsidiary or through its authorized agent in India (in case it does not have an Indian subsidiary). CDSCO will process such applications for Restricted Use in Emergency Situation and DCGI will consider and take a decision within 03 working days from date of submission of complete application by the applicant. DCGI will issue permission for Restricted Use in Emergency situation with, inter-alia, the following conditions: Vaccine shall be used as per the guidelines prescribed under National Covid-19 Vaccination Programme. First 100 beneficiaries of such vaccines shall be assessed for 7 days for safety outcomes before it is rolled out for further Vaccination program. Applicant shall initiate conduct of post approval bridging clinical trials within 30 days of such approval.     ]]> https://biospectrumindia.com/news/22/18427/centre-fast-tracks-emergency-approvals-for-foreign-made-covid-19-vaccines.html https://biospectrumindia.com/news/22/18427/centre-fast-tracks-emergency-approvals-for-foreign-made-covid-19-vaccines.html Tue, 13 Apr 2021 13:00:00 +0530 The matter of augmenting the basket of vaccines available for fighting the pandemic as well as to accelerate the pace & coverage of domestic vaccination programme was discussed in the 23rd meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) held on 11th April 2021, chaired by Dr. V K Paul, Member (Health), Niti Aayog. The NEGVAC, after comprehensive deliberation, recommended that vaccines for COVID-19, which have been developed & are being manufactured in foreign countries and which have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO(Emergency Use Listing) may be granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019. Further, the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country. The Union Government, after due consideration, has accepted the recommendation of NEGVAC. This decision will facilitate quicker access to such foreign vaccines by India & would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic. ]]> https://biospectrumindia.com/news/22/18420/experts-approve-sputnik-v-for-emergency-use-in-india-.html https://biospectrumindia.com/news/22/18420/experts-approve-sputnik-v-for-emergency-use-in-india-.html Mon, 12 Apr 2021 12:00:00 +0530 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has made the recommendation for the consideration and final decision of the Drugs Controller General of India (DCGI) to grant permission for restricted emergency use of Sputnik V vaccine. As part of the review process, Dr Reddy’s presented the safety profile of the phase 2 study, and interim data of the phase 3 study to the government. The vaccine is currently undergoing the phase 3 clinical trial in India.  The first interim data analysis of the Sputnik V vaccine against COVID-19 phase III clinical trials in the Russian Federation has demonstrated 92% efficacy. Sputnik V uses two different vectors - based on human adenovirus serotypes Ad5 and Ad26 - in two separate shots, allowing for a more effective defense against the coronavirus than vaccines using the same vector for both shots. By deploying two different vectors, Sputnik V avoids a possible neutralizing effect and generates a durable and longerlasting immune response. The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) has also recently partnered with New Delhi based Panacea Biotec to produce 100 million doses per year of Sputnik V in India.   ]]> https://biospectrumindia.com/news/22/18414/centre-disallows-export-of-remdesivir-injection-api.html https://biospectrumindia.com/news/22/18414/centre-disallows-export-of-remdesivir-injection-api.html Mon, 12 Apr 2021 08:00:00 +0530 India is witnessing a recent surge in COVID-19 cases. This has led to a sudden spike in demand for Injection Remdesivir used in treatment of COVID-19 patients. There is a potential of further increase in this demand in the coming days. Seven Indian companies are producing Injection Remdesivir under voluntary licensing agreement with Gilead Sciences, USA. They have an installed capacity of about 38.80 lakh units per month. In light of the above, Government of India has prohibited the exports of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) till the situation improves. In addition, Government of India has taken the following steps to ensure easy access of hospital and patients to Remdesivir: All domestic manufactures of Remdesivir have been advised to display on their website, details of their stockists/distributors to facilitate access to the drug. Drugs inspectors and other officers have been directed to verify stocks and check their malpractices and also take other effective actions to curb hoarding and black marketing. The State Health Secretaries will review this with the Drug Inspectors of the respective States/UTs. The Department of Pharmaceuticals has been in contact with the domestic manufacturers to ramp up the production of Remdesivir. ]]> https://biospectrumindia.com/news/22/18412/govt-identifies-strategic-actions-for-inclusion-of-homoeopathy-in-integrative-care.html https://biospectrumindia.com/news/22/18412/govt-identifies-strategic-actions-for-inclusion-of-homoeopathy-in-integrative-care.html Sat, 10 Apr 2021 17:00:00 +0530 A two-day convention on ‘Homoeopathy - Roadmap for Integrative Medicine’ was organized by the Central Council for Research in Homoeopathy (CCRH), an autonomous apex research organization under Ministry of AYUSH to celebrate the occasion of the World Homoeopathy Day on April 10. The World Homoeopathy Day (WHD) is observed to commemorate the birth anniversary of the founder of Homoeopathy, Dr. Christian Fredrich Samuel Hahnemann.  A unique digital initiative of CCRH, the Homoeopathic Clinical Case Repository (HCCR) portal aimed at providing homoeopathic clinicians, researchers, medical students etc. a user platform for entering homoeopathic clinical cases through a predefined standardized template was also launched.  The objective for this conference was exchange of experience by policy makers and experts to identify strategic actions towards an effective and efficient inclusion of Homoeopathy in integrative care.  The session on Homoeopathy in public health witnessed key speakers sharing the success stories of Homoeopathy in public health where the integration has been done at national programmes like National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular diseases and stroke (NPCDCS), Cancer and palliative care initiatives from Kerala state, Geriatric care, community-based initiative to curb malnutrition etc. ]]> https://biospectrumindia.com/news/22/18369/health-ministry-unveils-revamped-integrated-disease-surveillance-programme.html https://biospectrumindia.com/news/22/18369/health-ministry-unveils-revamped-integrated-disease-surveillance-programme.html Mon, 05 Apr 2021 17:35:00 +0530 Dr Harsh Vardhan, Union Minister of Health & Family Welfare, has virtually launched the Integrated Health Information Platform (IHIP), in the presence of Ashwini Kumar Choubey, Minister of State for Health and Family Welfare. The Integrated Health Information Platform is the next generation highly refined version of the presently used Integrated Disease Surveillance Programme (IDSP). The event was attended by health ministers of various states. Expressing his enthusiasm at the brave, futuristic and pertinent amalgamation of healthcare and technology, Dr Vardhan elaborated on the timely need for the software platform: “The new version of IHIP will house the data entry and management for India’s disease surveillance program. In addition to tracking 33 diseases now as compared to the earlier 18 diseases, it shall ensure near-real-time data in digital mode, having done away with the paper-mode of working.” Terming this as the world's biggest online disease surveillance platform, Dr Vardhan stated that it is in sync with the National Digital Health Mission and fully compatible with the other digital information systems presently being used in India. The refined IHIP with automated -data will help in a big way in real time data collection, aggregation & further analysis of data that will aid and enable evidence-based policy making, he explained. Dr Vardhan applauded NCDC, WHO and all those who have been associated with this development. Congratulating everyone associated with development of this visionary digital platform, Choubey stated that India has established standards of quality in healthcare: “With IHIP, collection of authentic data will become easy as it comes directly from the village/block level; the last mile from the country.” Rajesh Bhushan, Union Health Secretary informed that in terms of the geographical coverage of the surveillance, along with the number of diseases covered and the quantum of data generated, this makes IHIP one of the largest such digital health platforms globally.  Terming this as a ‘historic day’ not only for India for global public health, Dr Roderico Ofrin, WHO Representative to India stated that this refined digital surveillance platform will help to provide and connect data and move towards ‘one health’ approach. He mentioned that the portal is a great resource for timely health response measures to be mounted; not only programming, but also in disease prioritisation.   ]]> https://biospectrumindia.com/news/22/18365/revised-ppo-to-boost-domestic-medical-device-manufacturing-in-line-with-make-in-india-.html https://biospectrumindia.com/news/22/18365/revised-ppo-to-boost-domestic-medical-device-manufacturing-in-line-with-make-in-india-.html Mon, 05 Apr 2021 12:50:00 +0530 The revised notice issued by The Department of Pharmaceuticals (DoP) on the Public Procurement Order (PPO) on March 25, 2021, where they have incorporated 19 medical devices in the revised guidelines of the PPO will boost domestic medical device manufacturing by strengthening ‘Make in India’ and is estimated to reduce imports bill by approx Rs 4000 crore. This comes as a great relief to the 85 per cent import dependence forced upon India and an ever-increasing import bill of over Rs 42000 crore. Rajiv Nath, Forum Coordinator, AiMeD said, “This is a real boost to Make in India. This single strategic action will help boost domestic manufacturing imports bill reduction by nearly 10 per cent so approximately Rs 4000 Crore impact is foreseen.” While MNCs/overseas global investors are very welcome to Make in India, the reality is that very few have made efforts to put up greenfield projects in the last 10 years and the ones that have done so and other Indian entrepreneurs who have bravely invested and competed with imports in an ecosystem that’s favoured imports and made India over 85 per cent imports dependent need to be applauded.  The day has arrived to remove the digressive policies of encouraging and relying heavily on imports to meet India's needs for medical devices,” stated Mala Vazirani, Executive Director, Transasia and Jt Coordinator AiMeD, Legal Affairs.  “Covid-19 has shown the spirit of Indian entrepreneurs to Make in India rather than import into India. When imports got disrupted, specific devices detailed with quantified production shortages and a focused Inter-Ministry Group coordinating with domestic manufacturers via AiMeD had addressed production bottlenecks and challenges so that not only capacity got utilised but also ramped up rapidly. This spirit needs to be fanned not doused by seeking roll back of these initiatives” stated Rajiv Chibber, Vice President, SMT and Jt Coordinator Govt Affairs, AiMeD.  Such supporting policies are needed and need to be expanded to other medical devices so that Indian Medical Devices Industry can make quality healthcare accessible and affordable for the common masses,” concluded Nath. ]]> https://biospectrumindia.com/news/22/18361/rare-diseases-policy-2021-focuses-on-indigenous-research-for-treatment.html https://biospectrumindia.com/news/22/18361/rare-diseases-policy-2021-focuses-on-indigenous-research-for-treatment.html Mon, 05 Apr 2021 00:00:00 +0530 Dr Harsh Vardhan, Union Health & Family Welfare Minister approved the “National Policy for Rare Diseases 2021” on 30th March 2021.  For quite some time different stake holders have been demanding for a comprehensive policy for prevention and management of rare diseases.  The Rare Diseases Policy aims to lower the high cost of treatment for rare diseases with increased focus on indigenous research with the help of a National Consortium to be set up with Department of Health Research, Ministry of Health & Family Welfare as convenor.   Increased focus of research and development and local production of medicines will lower the cost of treatment for rare diseases. The policy also envisage creation of a national hospital based registry of rare diseases so that adequate data is available for definition of rare diseases and for research and development related to rare diseases within the country. The Policy also focuses on early screening and prevention through primary and secondary health care infrastructure such as Health and Wellness Centres and District Early Intervention Centres (DEICs) and through counselling for the high-risk parents. Screening will also be supported by Nidan Kendras set up by Department of Biotechnology. Policy also aims to strengthen tertiary health care facilities for prevention and treatment of rare diseases through designating 8 health facilities as Centre of Excellence and these CoEs will also be provided one-time financial support of up to Rs 5 crores for upgradation of diagnostics facilities.                     A provision for financial support up to Rs. 20 lakhs under the Umbrella Scheme of Rastriya Arogya Nidhi is proposed for treatment, of those rare diseases that require a one-time treatment (diseases listed under Group 1 in the rare disease policy). Beneficiaries for such financial assistance would not be limited to below poverty line (BPL) families, but the benefit will be extended to about 40% of the population, who are eligible under Pradhan Mantri Jan Arogya Yojana.   Besides, the Policy also envisages a crowd funding mechanism in which corporates and individuals will be encouraged to extend financial support through a robust IT platform for treatment of rare diseases. Funds so collected will be utilized by Centres of Excellence for treatment of all three categories of rare diseases as first charge and then the balance financial resources could also be used for research.  ]]> https://biospectrumindia.com/news/22/18348/niti-aayog-outlines-range-of-investment-opportunities-in-healthcare-sector.html https://biospectrumindia.com/news/22/18348/niti-aayog-outlines-range-of-investment-opportunities-in-healthcare-sector.html Tue, 30 Mar 2021 12:00:00 +0530 NITI Aayog, a policy think tank of the Government of India, has released a report outlining the range of investment opportunities in various segments of India’s healthcare sector, including hospitals, medical devices and equipment, health insurance, telemedicine, home healthcare and medical value travel. The report was released by NITI Aayog Member Dr VK Paul, CEO Amitabh Kant, and Additional Secretary Dr Rakesh Sarwal. In the first section, this report provides an overview of India’s healthcare sector, including insights about its employment generation potential, the prevailing business and investment climate as well as the overarching policy landscape. The second section highlights the key drivers of growth for the sector and the third elaborates upon the enabling policies and investment opportunities in seven key segments—hospitals and infrastructure, health insurance, pharmaceuticals and biotechnology, medical devices, medical tourism, home healthcare as well as telemedicine and other technology-related health services. In the hospital segment, the expansion of private players to tier-2 and tier-3 locations, beyond metropolitan cities, offers an attractive investment opportunity. With respect to pharmaceuticals, India can boost domestic manufacturing, supported by recent Government schemes with performance-linked incentives, as part of the Aatmanirbhar Bharat initiative. In the medical devices and equipment segment, expansion of diagnostic and pathology centres as well as miniaturized diagnostics have high potential for growth. Further, medical value travel, especially wellness tourism, has bright prospects, given India’s inherent strengths in alternative systems of medicine. Technology advancements such as Artificial Intelligence (AI), wearables and other mobile technologies, along with Internet of Things, also offer numerous avenues for investment. ]]> https://biospectrumindia.com/news/22/18289/nppa-issues-price-regulation-for-80-plus-medicines.html https://biospectrumindia.com/news/22/18289/nppa-issues-price-regulation-for-80-plus-medicines.html Sat, 20 Mar 2021 00:00:00 +0530 The National Pharmaceutical Pricing Authority (NPPA) NPPA has fixed the price of 81 medicines including off-patent anti-diabetic drugs allowing due benefits of patent expiry to the patients. NPPA has fixed the Retail Price of ‘Insulin Human Injection, 200IU/ml’ and ‘70% Isophane Insulin Human Suspension + 30% Insulin Human Injection 200IU/ml’ for M/s Wockhardt Ltd at Rs. 106.65 per ml each (excluding GST) and ‘Prasugrel Hydrochloride 10 mg (as film coated) + Aspirin 75 mg (as enteric coated) Capsule’ for Torrent Pharmaceuticals Ltd. at Rs. 20.16 per Capsule (excluding GST) with effect from 17.03.2021. Both the medicines were being sold at MRP of Rs. 132.50 per ml and at MRP of Rs. 27.26 per capsule respectively. With this price regulation, NPPA has re-assured availability of medicines at fair prices to public at large. NPPA had granted price exemption for above mentioned formulations to the respective  companies under Para 32 of the ‘Drug Prices Control Order (DPCO), 2013  for a period of five years due to new drug delivery system developed through indigenous Research and Development. Price regulation was not applicable during the exemption period. NPPA in its meeting on 10.03.2021 decided to regulate the price of these formulations as per provisions of DPCO, 2013 as the exemption period has been over. This has resulted in reduction of the prices of Insulin Human Injection, 200IU/ml’ and ‘70% Isophane Insulin Human Suspension + 30% Insulin Human Injection 200IU/ml’, causing sizeable reduction over the existing prices. Now, these medicines have become more affordable to the public. NPPA has also fixed retail price of 76 new drugs in the meeting dated 10th March 2021 to be launched by existing manufacturers including off-patent Anti-diabetic drugs allowing due benefit of patent expiry to the patients. In addition, NPPA fixed ceiling price of 2 scheduled formulation namely Povidone Iodine 7.5% Scrub an anti-infective formulation and Levo-Thyroxine 37.5mg tablet used for treatment of Thyroid related diseases, causing considerable reduction to their present prices. Revision in existing ceiling prices of scheduled formulations based on the Wholesale Price Index (WPI) was also approved by the Authority. The revised prices will be effective from April, 2021. ]]> https://biospectrumindia.com/news/22/18245/union-cabinet-approves-single-non-lapsable-reserve-fund-for-health.html https://biospectrumindia.com/news/22/18245/union-cabinet-approves-single-non-lapsable-reserve-fund-for-health.html Wed, 10 Mar 2021 20:00:00 +0530 The Union Cabinet, chaired by the Prime Minister, Narendra Modi, has approved the Pradhan Mantri Swasthya Suraksha Nidhi (PMSSN) as a single non-lapsable reserve fund for share of health from the proceeds of Health and Education Cess levied under Section 136-b of Finance Act, 2007. Salient features of the PMSSN: A non-lapsable reserve fund for health in the public account; Proceeds of share of health in the Health and Education Cess will be credited into PMSSN; Accruals into the PMSSN will be utilised for the flagship schemes of the Ministry of Health & Family Welfare namely: Ayushman Bharat - Pradhan Mantri Jan Arogya Yojana (AB-PMJAY), Ayushman Bharat - Health and Wellness Centres (AB-HWCs), National Health Mission, Pradhan Mantri Swasthya Suraksha Yojana (PMSSY) and Emergency & disaster preparedness and responses during health emergencies Any future programme/scheme that targets to achieve progress towards SDGs and the targets set out in the National Health Policy (NHP) 2017. Administration and maintenance of the PMSSN is entrusted to Ministry of Health & Family Welfare; and In any financial year, the expenditure on such schemes of the MoHFW would be initially incurred from the PMSSN and thereafter, from Gross Budgetary Support (GBS). The major benefit includes enhanced access to universal and affordable healthcare through the availability of earmarked resources while ensuring that the amount does not lapse at the end of the financial year. ]]> https://biospectrumindia.com/news/22/18234/ngt-clears-pet-bottles-for-pharma-packaging-.html https://biospectrumindia.com/news/22/18234/ngt-clears-pet-bottles-for-pharma-packaging-.html Tue, 09 Mar 2021 18:15:00 +0530 National Green Tribunal’s (NGT) recent order declaring PET bottles’ use safe for packaging of pharmaceuticals has finally given a rubber stamp on a scientific fact, endorsed by both the government, scientific community and the pharmaceutical industry. An especially designed plastic - polyethylene terephthalate or PET is widely used for packaging water, medicines, beverages, edible oil, etc across the world because of its safety, utility and economic viability for the packaging of products of mass consumption. PET is a clear, strong, safe, lightweight and completely recyclable plastic belonging to the polyester family. Recently, the principal bench of National Green Tribunal dismissed a litigation filed by Him, Jagriti Uttaranchal Welfare Society in 2014 stating that Indian government has already ensured guidelines for safe and regulated use of plastics for packaging and as the industry is adhering to global guidelines formulated under Pharmacopeia no further legislation changes are required. The order comes after an expert committee set up by the Health Ministry in 2015, led by former biotech secretary Dr MK Bhan, submitted a report to the tribunal stating, “There is no conclusive evidence to suggest that use of PET or additive like antimony for pharmaceutical packaging may leach substances beyond limits that pose threat to human health.” “The Covid-19 pandemic has re-established the importance of PET, with its ubiquitous presence as the packaging for the multitude of sanitizers, blood collection tubes, food containers, water bottles, Ayurvedic kadhas (concentrates), nutraceuticals, etc. PET saves invaluable natural resources being able to recycling and reuse. Its lightweight characteristic makes it friendly for take-away foods, travel and relief work and serves as a good ancillary in the fight against communicable diseases. So, this NGT order comes in at the right time to affirm that PET is safe. PET clearly is an inseparable packaging of several products,” says Dr Rao VSV Vadlamudi, Former President, Indian Pharmaceutical Association. Sachin Sharma, Director, GEM Recycling states, “The safety of PET has been repeatedly demonstrated through extensive studies, regulatory approvals and scientific testing, as well as its widespread use and acceptance for more than three decades. The order must pave way for strengthening regulatory guidelines by prescribing specific methods for disposal of pharmaceutical packaging wastes.” ]]> https://biospectrumindia.com/news/22/18224/impcl-sales-volume-skyrocket-after-tie-up-with-gem-portal-.html https://biospectrumindia.com/news/22/18224/impcl-sales-volume-skyrocket-after-tie-up-with-gem-portal-.html Mon, 08 Mar 2021 13:05:00 +0530 Indian Medicines Pharmaceutical Corporation Limited (IMPCL), the public sector manufacturing unit of the Ministry of AYUSH, has received a shot in the arm in the matter of potential sales volumes, thanks to the recent tie up with the Government e-Market (GeM) portal for selling its products online. The deal between IMPCL and GeM was finalised on March 3, 2021, when GeM created 31 categories covering 311 medicines, which are live in the marketplace and IMPCL can now upload these medicines on GeM Portal. IMPCL, the Rs 100 crore turnover PSU of the Ministry of AYUSH, is one of the most trusted manufacturers of Ayush medicines in the country, and is known for the authenticity of its formulations. IMPCL is the only CPSE under Ministry of AYUSH, Government of India and its prices are vetted and finalised by the Ministry of Finance (Department of Expenditure) for their Ayurvedic & Unani medicines. With this decision of GeM, the Ayurvedic and Unani medicines of IMPCL will figure on the GeM portal to hundreds of government sector buyers, at prices finalised by Ministry of Finance, Department of Expenditure. This will facilitate quick procurement of these medicines by Central/State Government institutions for their healthcare programmes. Thus, this tie-up between GeM & IMPCL also helps to streamline the procurement and distribution of Ayurvedic and Unani medicines by State Units. The thousands of patients and other clients who visit Government Ayush hospitals every day stand to gain because of this increased availability of such medicines even in far-flung Ayush Hospitals and Clinics. ]]> https://biospectrumindia.com/news/22/18180/eligible-ab-pm-jay-beneficiaries-to-receive-free-pvc-cards-starting-march-1-2021.html https://biospectrumindia.com/news/22/18180/eligible-ab-pm-jay-beneficiaries-to-receive-free-pvc-cards-starting-march-1-2021.html Mon, 01 Mar 2021 11:20:00 +0530 National Health Authority (NHA) has entered into an agreement with Common Service Centre (e-governance) to issue free PVC card Ayushman cards to eligible beneficiaries of Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) starting from March 1, 2021 in 10 States/UTs ie Bihar, Manipur, Uttar Pradesh, Haryana, Tripura, Nagaland, Chandigarh, Puducherry, Chhattisgarh, and Madhya Pradesh. As per the MoU between NHA and Common Service Centre signed on Feb 18, 2021, the above mentioned States/UTs are among the first to agree issue new PVC Ayushman cards free to all eligible beneficiaries free of cost. Until now it was required to pay Rs 30 as fees at CSC. Ayushman cards generated at any of the PM-JAY empanelled hospitals, however, were issued for free and will continue to be issued free of charge. Under the new arrangement, Ayushman Bharat PM-JAY beneficiaries will receive a paper-based card on the spot post approval of the record. Subsequently, a printed PVC card would be provided to the beneficiary, free of cost. The PVC Ayushman Card can be collected from same CSC centre. While the Ayushman card is not an essential requirement to avail healthcare benefits under the AB PM-JAY scheme, it is part of mechanism for the identification and verification of beneficiaries to enable seamless delivery of health services to the patients and prevent any kind of malpractice and fraud. The date for issuance of free PVC Ayushman Cards in other States/UTs will be informed shortly. ]]> https://biospectrumindia.com/news/22/18174/govt-allocates-pli-scheme-of-rs-6940-cr-for-bulk-drugs-rs-3420-cr-for-medical-devices.html https://biospectrumindia.com/news/22/18174/govt-allocates-pli-scheme-of-rs-6940-cr-for-bulk-drugs-rs-3420-cr-for-medical-devices.html Thu, 25 Feb 2021 17:55:00 +0530 Speaking at the inauguration ceremony of India Pharma 2021 & India Medical Devices 2021 organised by FICCI along with the Department of Pharmaceuticals, Ministry of Chemicals & Fertilisers, Government of India, and Invest India, DV Sadananda Gowda, Minister for Chemicals and Fertilisers, Government of India said, “ The Department of Pharmaceuticals launched the Production Linked Incentive Scheme for bulk drugs, with a financial outlay of Rs 6,940 crore across 53 APIs over six years. For medical devices, another PLI scheme was announced with an outlay of Rs 3,420 crore. The medical devices industry in India has the potential to grow at 28 per cent pa to reach $50 bn by 2025. Moreover, FDI growth has been close to 100 per cent year on year.” Piyush Goyal, Minister of Railways, Commerce and Industry, Consumer Affairs and Food & Public Distribution said, “57 countries have already joined India's leadership in demanding Intellectual Property Waiver for COVID-19 vaccine. Regulatory & good manufacturing practices, systems and certifications, approvals, will always help us grow in scale and bring down the price.” Mansukh L Mandaviya, Minister of State for Chemicals and Fertilisers, Government of India, said, “As India continues to strengthen its status as a leading investment destination by continuously improving its Ease of Doing Business through the enactment of several policy measures especially during the COVID-19 pandemic to ensure continuity, I am sure this platform will be instrumental in contributing to India’s growth story and to chart out the path of progress of both the industry & the country.” Addressing on the medical device industry, Dr Shravan Subramanyam, Co-Chair, Medical Devices Committee, FICCI, President & CEO, GE Healthcare South Asia said, "The 2021 budget has focused on a stronger public healthcare system. It has dedicated ₹14000 crores to the pharma & MedTech infrastructure industry over six years. To achieve the universal goals and make India self-resilient, the first step is to build mutual trust and develop innovative partnership models and Integrate digital technology and tools which can bring in the needed transparency and accountability.”   The winners of 6th India Pharma 2021 & India Medical Devices awards: Category No. Category Name Name of Awardee 1 India Pharma Leader Award Laurus Labs Limited 2 India Pharma Bulk Drug Company of the Year Award Metrochem API Private Limited 3 India Pharma Innovation of the year Award Glenmark Pharmaceuticals Limited 4 India Pharma Corporate Social Responsibility (CSR) Programme of the Year Award Lupin Limited 5 India Medical Devices Company of the Year Award Wrig Nanosystems Private Limited 6 Special Award in recognition of exceptional leadership & contribution in handling the supply of essential medicine & medical products during the period of COVID-19 pandemic in 2020 Dr. P.D. Vaghela, Former Secretary, Department of Pharmaceuticals   ]]> https://biospectrumindia.com/news/22/18168/centre-approves-pli-scheme-for-pharmaceuticals-for-fy-2020-21-to-2028-29.html https://biospectrumindia.com/news/22/18168/centre-approves-pli-scheme-for-pharmaceuticals-for-fy-2020-21-to-2028-29.html Wed, 24 Feb 2021 19:00:00 +0530 The Union Cabinet, chaired by Prime Minister, Narendra Modi has approved Production Linked Incentive (PLI) Scheme for pharmaceuticals over a period of Financial Year 2020-21 to 2028-29. The scheme will benefit domestic manufacturers, help in creating employment and is expected to contribute to the availability of wider range of affordable medicines for consumers. The scheme is expected to promote the production of high value products in the country and increase the value addition in exports. Total incremental sales of Rs 2,94,000 crore and total incremental exports of Rs 1,96,000 crore are estimated during six years from 2022-23 to 2027-28. The scheme is expected to generate employment for both skilled and un-skilled personnel, estimated at 20,000 direct and 80,000 indirect jobs as a result of growth in the sector. It is expected to promote innovation for development of complex and high-tech products including products of emerging therapies and in-vitro diagnostic devices as also self-reliance in important drugs.  It is also expected to improve accessibility and affordability of medical products including orphan drugs to the Indian population. The scheme is also expected to bring in investment of Rs.15,000 crore in the pharmaceutical sector. The scheme will be part of the umbrella scheme for the Development of Pharmaceutical Industry. The objective of the scheme is to enhance India's manufacturing capabilities by increasing investment and production in the sector and contributing to product diversification to high value goods in the pharmaceutical sector. ]]> https://biospectrumindia.com/news/22/18150/india-comes-out-first-to-identify-need-for-action-for-nafld.html https://biospectrumindia.com/news/22/18150/india-comes-out-first-to-identify-need-for-action-for-nafld.html Tue, 23 Feb 2021 12:55:00 +0530 Dr Harsh Vardhan, Union Minister, Health & Family Welfare, has launched the operational guidelines for integration of NAFLD (Non-Alcoholic Fatty Liver Disease) with NPCDCS (National Programme for Prevention & Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke). The Minister expanding on the government’s plan to curb deaths due to NCDs linked with the condition said, “NAFLD is an independent predictor of future risk of cardiovascular diseases, type 2 diabetes and other metabolic syndromes like hypertension, abdominal obesity, dyslipidaemia, glucose intolerance. The Government of India is of the view that existing NPCDCS programme strategies can easily be aligned to prevent NAFLD through lifestyle changes, early diagnosis, and management of associated non-communicable diseases as well as NAFLD.” The Health Minister also took the occasion to remind the audience that India is becoming the first country in the world to identify the need for action for NAFLD. He said, “The Government of India has realised that the existing NCD programme’s strategies can now be aligned to achieve the objectives to prevent and control NAFLD with: (i) behaviour and lifestyle changes,      (ii) early diagnosis and management of NAFLD,      (iii) building of capacity at various levels of healthcare for prevention, diagnosis and treatment of NAFLD.         To broaden the movement, he suggested that health journalists and media in general play an important role in spreading awareness and information on NCDs and how a fit lifestyle can help avoid them and encouraged everyone to improve their own health awareness and remain physically active. ]]> https://biospectrumindia.com/news/22/18139/union-health-minister-flags-off-intensified-mission-indradhanush-3-0.html https://biospectrumindia.com/news/22/18139/union-health-minister-flags-off-intensified-mission-indradhanush-3-0.html Fri, 19 Feb 2021 18:20:00 +0530 Dr Harsh Vardhan, Union Minister of Health and Family Welfare, has launched Intensified Mission Indradhanush 3.0. Ashwini Kumar Choubey, Minister of State for Health and Family Welfare and Mangal Pandey, Health Minister, Bihar were also present during the occasion through video conference. The Union Minister also launched the IMI 3.0 portal and released the Operational Guidelines for IMI 3.0 and the awareness material/IEC package developed as part of the campaign. Dr Vardhan expressed: The Intensified Mission Indradhanush 3.0 will have two rounds starting from February 22 and March 22, 2021 and will be conducted in pre-identified 250 districts/urban areas across 29 States/UTs in the country. Focus of the IMI 3.0 will be the children and pregnant women who have missed their vaccine doses during the COVID-19 pandemic. They will be identified and vaccinated during the two rounds of IMI 3.0. Each round will be for 15 days each.  Dr Vardhan said, “Mission Indradhanush is indeed a successful strategy to reach out to every dropped out and left out child and pregnant woman. There has been remarkable improvement in the immunisation coverage which is also evident in the NFHS5 data as available for 22 States.” Choubey said, “Mission Indradhanush & Intensified Mission Indradhanush has enabled the immunisation system in reaching hard to reach and high-risk areas including brick kilns, construction sites and nomadic population.” States have been asked to follow 'staggered approach’ to avoid crowding at the session sites and even plan break-up sessions if staggered approach is not effective to avoid crowding.  Senior health officials of state governments and representatives of development partners like UNDP, BMGF joined virtually.               ]]> https://biospectrumindia.com/news/22/18089/govt-launches-pli-scheme-for-manufacturing-of-medical-devices-with-rs-3420-cr.html https://biospectrumindia.com/news/22/18089/govt-launches-pli-scheme-for-manufacturing-of-medical-devices-with-rs-3420-cr.html Thu, 11 Feb 2021 18:30:00 +0530 The medical device sector in India suffers from a considerable cost of manufacturing disability vis-à-vis competing economies, inter alia, on account of lack of adequate infrastructure, domestic supply chain and logistics, high cost of finance, inadequate availability of power, limited design capabilities, low focus on research and development (R&D) and skill development etc. With an objective to boost domestic manufacturing, attract large investment in the medical device sector, the Department of Pharmaceuticals has launched a Production Linked Incentive (PLI) Scheme for Promotion of Domestic Manufacturing of Medical Devices to ensure a level playing field for the domestic manufacturers of medical devices with a total financial outlay of Rs 3,420 crore for the period 2020-21 to 2027-28. The applications under four different Target Segments including 'Cancer care/Radiotherapy Medical Devices’, 'Radiology & Imaging Medical Devices (both ionising & non-ionising radiation products) and Nuclear Imaging Devices’, ‘Anaesthetics & Cardio-Respiratory Medical Devices including Catheters of Cardio-Respiratory Category & Renal Care Medical Devices’ and ‘All Implants including Implantable Electronic Devices’ were invited. The Government has approved applications of Siemens Healthcare, Allengers Medical Systems, Allengers OEM, Wipro GE Healthcare, Nipro India Corporation, Sahajanand Medical Technologies, Innvolution Healthcare and Integris Health. The setting up of these plants will lead to a total committed investment of Rs 729.63 crore by the companies and employment generation of about 2,304. The commercial production is projected to commence from April 1, 2022 and the disbursal of production linked incentive by the Government over the five years period would be up to a maximum of Rs 121.00 crore per applicant per target segment. The setting of these plants will make the country self-reliant to a large extent in the specified target segments in the Medical Devices Sector. The remaining pending applications are proposed to be taken up for approval by end of February, 2021. ]]> https://biospectrumindia.com/news/22/18065/centre-foresees-growth-of-pharma-industry-to-tune-of-130-b-by-2030-.html https://biospectrumindia.com/news/22/18065/centre-foresees-growth-of-pharma-industry-to-tune-of-130-b-by-2030-.html Mon, 08 Feb 2021 17:15:00 +0530 The Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India jointly with FICCI & Invest India is organising the 6th edition of annual programme on Pharmaceuticals & Medical Device sector – ‘India Pharma & India Medical Device 2021’ scheduled on February 25-26 & March 1-2, 2021. The theme for this year India Pharma is ‘Indian Pharma Industry: 'Future is Now’ and for India Medical Device is ‘India MedTech Future: Innovate & Make in India through Global Alliance’. Speaking at the event, DV Sadananda Gowda, Minister for Chemicals and Fertilizers, Government of India congratulated the pharma, medical device and healthcare industry partners for their outstanding work during the pandemic. Gowda said, “The India Pharma 2021 & India Medical Device 2021 will lay the groundwork for the next wave of development.” He added saying that we are talking about two very high potential sectors of India in this event. The total market size of the Indian pharma industry is expected to reach the $130 billion by 2030. The medical devices industry in India has the potential to reach $50 billion by 2025. The introduction of the PLI Scheme for domestic manufacturing of medical devices with an outlay of Rs 3,420 crore has also made major huge strides in the sector & is expected to continue to support further. Mansukh Mandaviya, Minister of State for Chemicals and Fertilizers, Govt of India said owing to the paramount importance of the pharmaceuticals & medical devices sector, the India Pharma & Medical Devices 2021 is a timely affair and will allow us to deliberate upon the opportunities and key challenges in the areas of the sectors. S Aparna, Secretary, Department of Pharmaceuticals, mentioned that to further provide business linkages & remove bottlenecks in the growth of the sector this edition of event will be organised virtually and participants from across the globe will participate. ]]> https://biospectrumindia.com/news/22/18057/pm-modi-flooded-with-pledges-seeking-urgent-national-policy-for-paediatric-cancer.html https://biospectrumindia.com/news/22/18057/pm-modi-flooded-with-pledges-seeking-urgent-national-policy-for-paediatric-cancer.html Fri, 05 Feb 2021 14:50:00 +0530 On the occasion of World Cancer Day, kids with cancer and their parents from across India are writing letters to the PM and urging for a national plan and policy for childhood cancer in India. Pledges have been collected online and through pledge books and pledge sheets from patient beneficiaries – parents and survivors, healthcare professionals- doctors, nurses, and workers, hospital administrations, Govt officials, politicians, celebrities, donors, NGOs, schools, colleges, media and civil society - that’s 300,000 people from all over India and overseas who have signed up and want childhood cancer to be a child & health priority in India. The young cancer survivor group have been leading 'Haqkibaat campaign’ and asking their Mann Ki Baat PM for a National plan for childhood cancer. A cancer awareness rally will leave for PMO on Feb 15, International Childhood Cancer Day from AIIMS to Lok kalyan Marg. Poonam Bagaisaid, Chairman, Cankids, said, “WHO Global Initiative for Childhood Cancer (GICC) has set a target of 60 per cent of survival for children with cancer in Low Middle-Income Country like ours and to reduce the suffering for all children with cancer by 2030. In the High-Income countries 80 per cent of children with cancer will Survive but in the Low-and Middle-Income Countries, only 20 per cent of children will survive. This data reflects that we are in serious war in fight against cancer – childhood cancer is the low hanging fruit and its high time to have a national Childhood Cancer Plan and Policy to make it a health priority of India. ]]> https://biospectrumindia.com/news/22/18022/union-budget-focused-on-wealth-wellness-msme-infrastructure-pm.html https://biospectrumindia.com/news/22/18022/union-budget-focused-on-wealth-wellness-msme-infrastructure-pm.html Mon, 01 Feb 2021 00:00:00 +0530 The Prime Minister (PM), Narendra Modi said that the Budget this year has a feel of reality and confidence of development and showcases India’s self-belief. He also said that it will infuse a new confidence in the world in these difficult times. In his remarks after the Union Budget was tabled in the Lok Sabha, the Prime Minister said that the Budget carries a vision of Aatamnirbharta and inclusion of every citizen and section. Modi explained that the principles behind the Budget include – expansion of new opportunities for growth; new opportunities for the youth; giving new dimension to human resource; infrastructure development and helping new sectors grow. Appreciating the all-round development emphasis of the Budget, the PM said that it is focused on wealth and wellness, MSME and infrastructure. He also noted unprecedented focus on healthcare. Mentioning the impact of the Budget on the various segments of society, Modi said its emphasis on research and innovation will help the youth. Common men and women will be benefitted by stress on health, swachchta, nutrition, clean water and equality of opportunities. Similarly, enhanced allocation in infrastructure and procedural reforms will lead to job creation and growth. Dr. Harsh Vardhan, Union Minister of Health and Family Welfare expressed his deep gratitude and profusely thanked Prime Minister Narendra Modi and Finance Minister Nirmala Sitharaman for moving health and well being to the centre stage of India’s governance as the country battles COVID and is also targeting to eliminate diseases like TB and immunize India’s children against twelve communicable diseases. Speaking on COVID-19 and other communicable diseases and their prevention through vaccination, he noted, “The COVID-19 vaccination drive was inaugurated by the Prime Minister on 16th January and is presently being given to Health Care Workers and the Frontline Workers; others along the priority pyramid will be given the vaccine in coming times. The Union Finance Minister has allocated Rs. 35,000 Cr for it and also stated that she will provide more fund if required, which will be a huge boost to the morale of the country. The Pneumococcal vaccine, similarly, a ‘Made in India’ product which is presently limited to 5 states at present will also be rolled out across the country. This will avert more than 50,000 child deaths annually.” ]]> https://biospectrumindia.com/news/22/17976/govt-to-set-up-vaccine-testing-lab-in-hyderabad.html https://biospectrumindia.com/news/22/17976/govt-to-set-up-vaccine-testing-lab-in-hyderabad.html Thu, 21 Jan 2021 18:45:00 +0530 Muppavarapu Venkaiah Naidu, Vice President of India spoke to Dr Harsh Vardhan, Union Health Minister and urged the Centre to consider the request of the Telangana government to set up a vaccine testing and certification laboratory at the Genome Valley in Hyderabad.  Naidu referred to the request made by KT Rama Rao, IT Minister, Telangana, to the Union Health Minister in this regard. Rao, in a letter to the Union Health Minister pointed out that Hyderabad was manufacturing over six billion doses annually and contributing one-third of global vaccines production.  Dr Vardhan assured the Vice President that he would examine the request from all angles. He also informed the Vice President that there were seven vaccine testing and certification laboratories in the world, including the one at Kasauli in Himachal Pradesh, and that an accreditation would be required from an international body for such a facility.     ]]> https://biospectrumindia.com/news/22/17969/delhi-tops-list-of-india-innovation-index-in-second-edition.html https://biospectrumindia.com/news/22/17969/delhi-tops-list-of-india-innovation-index-in-second-edition.html Wed, 20 Jan 2021 00:00:00 +0530 NITI Aayog, along with the Institute for Competitiveness, has released the second edition of the India Innovation Index in a virtual event. The report examines the innovation capabilities and performance of the states and union territories.The first edition of the index was launched in October 2019. The India Innovation Index 2020 was released by NITI Aayog Vice Chairman Dr Rajiv Kumar, in the presence of Member (Health) Dr VK Paul, Member (Agriculture) Dr Ramesh Chand, CEO Amitabh Kant, Adviser (Science and Technology) Neeraj Sinha, andInstitute for Competitiveness Chair Dr Amit Kapoor. The event was attended by Department of Scientific and Industrial Research Secretary Dr Shekhar C. Mande, Department of Biotechnology Secretary Dr Renu Swarup, Ministry of Earth Sciences Secretary Dr MN Rajeevan, Ministry of Civil Aviation Secretary Pradeep Singh Kharola, and Ministry of Statistics and Programme Implementation Secretary Dr Kshatrapati Shivaji, among others. Overall, Delhi retained its first rank, while Chandigarh made a big leap since 2019 and landed in the second place this year. Under the ‘North-Eastern/Hill States’ category, Himachal Pradesh moved up from the second position to emerge as the top ranker this year, while 2019’s top performer (in this category), Sikkim, slipped down to the fourth position. The India Innovation Index aims to create an extensive framework for the continual evaluation of India’s innovation environment. The index aims to rank states and UTs based on their scores, recognize opportunities and challenges, and assist in tailoring government policies to foster innovation. During the event, NITI Aayog Vice Chairman Dr Rajiv Kumar said, ‘The India Innovation Index will create synergies between different stakeholders in the innovation ecosystem, thus enabling India to shift to competitive good governance.’ He also said the index is a great beginning to improve the innovation environment in the country. It is the right step towards making India the innovation leader of the world. ]]> https://biospectrumindia.com/news/22/17952/dcgi-grants-approval-for-ph-iii-trial-of-sputnik-v-vaccine.html https://biospectrumindia.com/news/22/17952/dcgi-grants-approval-for-ph-iii-trial-of-sputnik-v-vaccine.html Mon, 18 Jan 2021 13:40:00 +0530 Dr Reddy’s Laboratories has announced that it has received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine in India. The phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study in India. Earlier, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial of the vaccine and recommended the phase 3 recruitment. In its report, the DSMB concluded that no safety concerns were identified and the study met the primary endpoints of safety. GV Prasad, Co-Chairman and Managing Director, Dr Reddy’s Laboratories said, “This is an important milestone in the progress of this pivotal clinical trial of the vaccine. We expect to commence the phase 3 study within this month and will continue to fast-track our efforts to bringing in a safe and efficacious vaccine for the Indian population.” ]]> https://biospectrumindia.com/news/22/17940/govt-opens-new-institute-for-science-communication-policy-research.html https://biospectrumindia.com/news/22/17940/govt-opens-new-institute-for-science-communication-policy-research.html Thu, 14 Jan 2021 18:50:00 +0530 Dr Harsh Vardhan, Union Minister of Science & Technology, Earth Sciences and Health & Family Welfare has inaugurated a new institute of Council of Scientific and Industrial Research (CSIR) ie CSIR-National Institute of Science Communication and Policy Research (CSIR-NIScPR), in New Delhi. The new institute has been established consequent to the merger of two prestigious institutes of CSIR namely, CSIR-National Institute of Science Communication and Information Resources (CSIR-NISCAIR)and CSIR-National Institute of Science, Technology and Development Studies (CSIR-NISTADS) which work at the interface of S&T and Society; and Science Communication and Policy Research. Dr Vardhan highlighted that the purpose of this merger is to combine the strength of the two institutes in a synergistic way with a vision to become a globally respected think tank and resource centre for understanding science, technology and innovation (STI) Policy Research and communication. Dr Shekhar C Mande, Director General, CSIR, highlighted that the mission of the institute is to promote STI policy studies and science communication among diverse stakeholders and act as a bridge at the interface of science, technology, industry and society which is essential to a robust S&T ecosystem in the country. Prof Ranjana Aggarwal, Director CSIR-NISCAIR & CSIR-NISTADS highlighted the key roles played by both the institutes in the past few decades. CSIR-NISCAIR, has been a frontier institute in science communication publishing popular science magazines (Vigyan Pragati and Science Reporter) and Scientific Journals. ]]> https://biospectrumindia.com/news/22/17933/all-preparations-on-track-for-covid-19-vaccine-roll-out-from-16-jan-.html https://biospectrumindia.com/news/22/17933/all-preparations-on-track-for-covid-19-vaccine-roll-out-from-16-jan-.html Wed, 13 Jan 2021 00:00:00 +0530 The central government has informed that 1.10 crore doses of COVISHIELD vaccine are being procured from the Serum Institute of India (SII) at the cost of Rs. 200/dose (excluding taxes). On the other hand, 55 lakh doses of COVAXIN vaccine are being procured from Bharat Biotech. The cost of 38.5 lakh doses of COVAXIN is Rs 295/dose (excluding taxes) but the company is providing 16.5 lakh doses of COVAXIN free of cost to the Central government. Hence, the cost of COVAXIN is Rs. 206/dose. All preparations are on track for COVID-19 vaccine roll-out from 16 January 2021. 26 virtual meetings/trainings have been held with States/UTs, 2360 Master Trainers, 61,000 Programme Managers, 2 lakh Vaccinators, 3.7 lakh other Vaccination Team Members have been trained so far. The cost of vaccination of Health Care Workers & Front Line Workers will be borne by the central government. All states have at least one state level regional vaccine store. In particular, Uttar Pradesh has 9, Madhya Pradesh has 4, Gujarat has 4, Kerala has 3, J&K has 2, Karnataka has 2 and Rajasthan has 2 stores. As on 12 January, 54,72,000 doses were received. 100% doses are to be received by 14th Jan 2021 in all states/UTs. The government has also highlighted the current status of other vaccines in India- Zydus Cadila- Phase III trial begin in January 2021 Sputnik V- Phase II & III trials are ongoing Biological E- Phase I trials are ongoing Gennova Biopharma- Phase I trial results have been approved. Phase II trials may begin from March 2021. ]]> https://biospectrumindia.com/news/22/17898/health-ministry-releases-report-on-longitudinal-ageing-study-of-india.html https://biospectrumindia.com/news/22/17898/health-ministry-releases-report-on-longitudinal-ageing-study-of-india.html Wed, 06 Jan 2021 18:10:00 +0530 Dr Harsh Vardhan, Union Minister for Health & Family Welfare released India Report on Longitudinal Ageing Study of India (LASI) Wave-1 on the virtual platform. LASI is a full–scale national survey of scientific investigation of the health, economic, and social determinants and consequences of population ageing in India. The LASI, Wave 1 covered a baseline sample of 72,250 individuals aged 45 and above and their spouses including 31,464 elderly persons aged 60 and above and 6,749 oldest-old persons aged 75 and above from all States and Union Territories (UTs) of India (excluding Sikkim). Dr Vardhan noted, “The LASI has embraced state-of-the-art large-scale survey protocols and field implementation strategies including representative sample of India and its states, socioeconomic spectrum, an expansive topical focus, a longitudinal design, and the use of Computer Assisted Personal Interviewing(CAPI) technology for data collection, quality control, and Geographic Information System (GIS). A unique feature of LASI is the coverage of comprehensive biomarkers.” The Minister affirmed that the LASI data shall assist in addressing the broad aims of the Decade of Healthy Ageing and will lead to convergence within various national health programmes and also promote inter-sectoral coordination with other line Departments/Ministries. ]]> https://biospectrumindia.com/news/22/17883/indias-covid-vaccine-is-a-leap-of-science-vice-president-.html https://biospectrumindia.com/news/22/17883/indias-covid-vaccine-is-a-leap-of-science-vice-president-.html Mon, 04 Jan 2021 17:15:00 +0530 Venkaiah Naidu, Vice President of India and Chairman, Rajya Sabha has hailed the emergency authorisation of two COVID vaccines as India's leap of science that benefits humanity at large. Writing on social media, Naidu stressed that this is an indication of how Atmanirbhar Bharat can benefit not only Indians but the larger humanity. Naidu said; "India is in the forefront of shielding humanity from the deadly disease by demonstrating its ability to mass produce the much needed vaccine and offer its own version as well. India's indigenous vaccine (Covaxin) has certain unique features based on the whole virus approach. This is a commendable achievement and all concerned deserve kudos for foresight perseverance and fruition of spirited efforts." Noting that development and administering of vaccine is guided by a stringent regime of protocols and strict monitoring of attendant data without any compromise, the Vice President referred to the regulator's assurance to the nation of due diligence before giving nod to the two vaccines, Covishield and Covaxin. Naidu observed that the country rose in unison in 2020 in handling the COVID situation with the national leadership both in the Centre and in the States/UTs working with a sense of unity of purpose and action which resulted in significantly enhancing the required capacities to fight the pandemic and containing the same. Naidu stressed on the need to demonstrate the same resolve in taking the vaccine to the people during this year. ]]> https://biospectrumindia.com/news/22/17881/experts-question-dcgi-approval-for-covid-19-vaccines-usage.html https://biospectrumindia.com/news/22/17881/experts-question-dcgi-approval-for-covid-19-vaccines-usage.html Mon, 04 Jan 2021 00:00:00 +0530 After the latest decision of DCGI to approve the vaccine jointly produced by UK-Swedish biopharmaceutical company AstraZeneca and Oxford University as well as by Bharat Biotech for emergency use in India to immunise people against the COVID-19 virus; many experts are questioning the foundation of these approvals. There has been ambiguity over AstraZeneca vaccine, ever since the data was published in the Lancet journal in the month of November last year proving that two full shots were 62.1% effective. AstraZeneca later announced plans to collaborate with Sputnik V whose efficacy showed to be 91.4% based on analysis of the data of the final control point of clinical trials. Should not there be more consideration and time given here?  "According to The Lancet- ‘In participants who received two standard doses, vaccine efficacy was 62.1% and in participants who received a low dose followed by a standard dose, efficacy was 90.0%. Overall vaccine efficacy across both groups was 70.4%.’ As India will possibly go by 2 full doses regimen, efficacy should have been quoted at 62.1%. The mention of the “overall” efficacy at 70% in this case is misleading. Moreover, AstraZeneca uses one and the same component for both inoculations, the Russian vaccine uses two different ones in two separate inoculations. Using the latter approach could prove more efficient in achieving a longer-lasting immune response”, said Dr. Debkishore Gupta, Consultant Clinical Microbiologist and Head of Infection Control, CK Birla Hospitals, Kolkata. "India has approved a full two-dose regimen with no dosing schedule specified. However, when the UK approved the same vaccine last week it was recommended that people get one dose followed by a second four to 12 weeks later in a bid to speed up the vaccination programme with officials claiming efficacy could be as high as 80 percent with three months between doses", he added. On the other hand, members of the All India Drug Action Network (AIDAN) have expressed disbelief over the approval of Bharat Biotech's vaccine COVAXIN. "It appears that no efficacy data for the vaccine candidate were submitted from the Phase 3 trials that are ongoing and being conducted by Bharat Biotech and ICMR.The only data for humans, available through publication pre-prints, are for safety and immunoogenicity from Phase 1 and Phase 2 trials, across a total of 755 participants. In the interest of transparency it will be in the fitness of things that the trial data on the basis of which decisions have been taken by the SEC are immediately made public", as stated by AIDAN. In particular, the member of AIDAN have urged the DCGI to reconsider the recommendations of the SEC in granting the restricted emergency use (REU) approval to COVAXIN. Adding to this debate is an observation by Dr Gagandeep Kang, Professor of Microbiology, at the Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences at the Christian Medical College (CMC) in Vellore, that there is not much awareness of any data on efficacy of the Bharat Biotech vaccine. She has openly expressed her confusion on this recent development by the government. In response to these uncertainities, Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech stated in a press conference that people should have the patience to read on the internet the published articles by the company. "Many people say that I am not transparent in my data. Our articles have been published in various international journals. Many people are gossiping, it's just a backlash against Indian companies", he added. These recent approvals have also brought the focus on other vaccine candidates such as Sputnik V and Pfizer that might have been currently neglected by the regulatory body. “The approval of the Bharat Biotech and AstraZeneca vaccines on the primary basis will kickstart the vaccination campaign. However, in the longer run keeping in mind the demand of the largely populated country like India and India’s promises to other countries, approval of other vaccines such as Pfizer and Sputnik V which are in the queue, would also be very critical. Other players are equally important and in order to cater to the domestic and global demand, mass vaccination is the key,” says Dr. Gajendra Singh, Public Health Expert. “It is interesting to note that what may have pushed AstraZeneca virologists to start work on combining their vaccine’s vector with that from Russia’s Sputnik V to see if that could help boost its vaccine’s efficacy. Unlike AstraZeneca, which uses one and the same component for both shots, the Russian vaccine uses two different ones for two separate inoculations and has much higher efficacy shown in Phase III clinical trials – 91.4 percent", he added. With these questions and recommendations by the experts, we hope that the government takes an informed decision for the benefit of the entire population.  ]]> https://biospectrumindia.com/news/22/17880/dcgi-issues-restricted-emergency-approval-of-covid-19-vaccines.html https://biospectrumindia.com/news/22/17880/dcgi-issues-restricted-emergency-approval-of-covid-19-vaccines.html Sat, 02 Jan 2021 00:00:00 +0530 The Subject Expert Committee of the Central Drugs Standard Control Organization (CDSCO) met on 1st and 2nd January, 2021 and made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of Serum Institute of India (SII) and Bharat Biotech as well as Phase III clinical trial of Cadila Healthcare Ltd. The Subject Expert Committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc. Serum Institute of India, Pune has presented a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University.  On the other hand, Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in the country & globally. Cadila Healthcare has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology. The firm initiated Phase-I/II clinical trial in India in more than 1000 participants which is ongoing. The interim data suggests that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, firm has sought permission to conduct Phase-III clinical trial in 26000 Indian participants, which has been recommended by the Subject Expert Committee. SII and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8° C. The Prime Minister, Narendra Modi has called the Drugs Controller General of India (DCGI) approval of Serum Institute and Bharat Biotech vaccines a decisive turning point to strengthen a spirited fight against corona. "DCGI granting approval to vaccines of Serum Inst of India and Bharat Biotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators”, he said.   ]]> https://biospectrumindia.com/news/22/17873/india-launches-sars-cov-2-genomic-consortium-to-monitor-viral-mutations.html https://biospectrumindia.com/news/22/17873/india-launches-sars-cov-2-genomic-consortium-to-monitor-viral-mutations.html Thu, 31 Dec 2020 16:20:00 +0530 The government has launched the Indian SARS-CoV-2 Genomic Consortia (INSACOG), comprising 10 labs namely DBT-NIBMG Kalyani, DBT-ILS Bhubaneswar, ICMR-NIV Pune, DBT-NCCS Pune, CSIR-CCMB Hyderabad, DBT-CDFD Hyderabad, DBT-InSTEM/ NCBS Bengaluru, NIMHANS Bengaluru, CSIR-IGIB Delhi, and NCDC Delhi. The overall aim of the Indian SARS-CoV-2 Genomics Consortium is to monitor the genomic variations in the SARS-CoV-2 on a regular basis through a multi-laboratory network. This vital research consortium will also assist in developing potential vaccines in the future. The consortium will ascertain the status of new variant of SARS-CoV-2 (SARS-CoV-2 VUI 202012/01) in the country, establish a sentinel surveillance for early detection of genomic variants with public health implication, and determine the genomic variants in the unusual events/trends (super-spreader events, high mortality/morbidity trend areas etc.). Dr RenuSwarup, Secretary, DBT, informed that INSACOG will have a high level Inter-Ministerial Steering Committee which will provide guidance and oversight to the consortium specially for policy matters and it will have a Scientific Advisory Group for scientific and technical guidance. The Indian SARS-CoV-2 Genomics Consortium (INSACOG) will monitor the genomic variations on a regular basis through the multi-laboratory network. Knowledge generated though this vital research consortium will also assist in developing diagnostics and potential therapeutics and vaccines in the future. DBT-NIBMG as the Co-ordinating Unit of Genome Sequencing Consortium will closely work with a Nodal Unit of NCDC on activities like SOPs, data annotation, data analysis, data release etc. NCDC will maintain a database of all samples of the new variants of public health significance. ]]> https://biospectrumindia.com/news/22/17857/national-medicinal-plants-board-launches-consortia-of-medicinal-plants.html https://biospectrumindia.com/news/22/17857/national-medicinal-plants-board-launches-consortia-of-medicinal-plants.html Tue, 29 Dec 2020 14:50:00 +0530 The National Medicinal Plants Board (NMPB), Ministry of AYUSH has envisaged the necessity of connectivity between stakeholders in the supply chain and value chain of Medicinal Plants. NMPB Consortia will address/deliberate (not limited to) on quality planting material, research & development, cultivation, trade of medicinal plants/market linkage etc. To establish the linkage between the farmers and manufacturers, a ‘Seed to Shelf’ approach is being introduced, wherein, aspects related to quality planting materials (QPM), good agriculture practices (GAP’s), good post harvest practices (GPHP’s) would be addressed. In the first phase NMPB consortia is proposed for medicinal plant species - Ashwagandha (Withania somnifera), Pippali (Piper longum), Amla or Indian Gooseberry (Phyllanthus emblica), Guggulu (Commiphora wightii), Satavari (Asparagus racemosus). Registration link for NMPB Consortia is available on the website of NMPB wherein, eligible organisations viz, Farmers/ FPOs/ FPCs/QPM centres/ Seed banks/ Nurseries/ SHGs/ NGOs/ Traders/manufactures/Exporters/Pharma/Research institutes / Agriculture Universities can register to be part of consortia. ]]> https://biospectrumindia.com/news/22/17840/nmmta-seeks-redressal-from-niti-aayog-for-new-reforms-in-medical-courses.html https://biospectrumindia.com/news/22/17840/nmmta-seeks-redressal-from-niti-aayog-for-new-reforms-in-medical-courses.html Mon, 28 Dec 2020 13:55:00 +0530 The Education Ministry and the Ministry of Health and Family Welfare have assured the National MSc Medical Teachers' Association (NMMTA) of addressing their concerns regarding the reforms in the conduct of Medical MSc courses and the roles of such scientists as teachers in medical colleges. This comes in wake of the recent controversial move of the National Medical Commission to downsize the percentage of scientist teachers in medical colleges. Dr Sridhar Rao, President, NMMTA and Arjun Maitra, General Secretary, NMMTA met key officials of NITI Aayog and the Health Secretary (MoHFW) seeking solutions to their concerns. "Medical MSc courses, which are conducted in the medical colleges on the lines of MD courses need reforms. Ever since MCI silently abandoned regulating these courses, they are now regulated by individual health universities. In the absence of a regulating scientific council, there are variations in these courses with respect to the mode of admissions, duration of courses, dissertation, etc. Also, the curriculum needs to be upgraded with the changing times,” said Dr Rao. “PhD aspirants those who wish to appear for NET examination for PhD are forced to take an exam on life sciences as no separate subjects are available for those who pursue Medical MSc subjects. General MSc & Medical MSc are different as the former is the core life sciences and the later one is specialised to suit the medical field,” said Maitra. Key officials of NITI Aayog that deal with education have assured the association to study these issues and address them suitably. Meanwhile, the association has filed a writ petition in the Delhi High Court challenging these regulations, which will hear next on February 17, 2021.    ]]> https://biospectrumindia.com/news/22/17832/govt-seeks-startups-participation-for-effective-covid-19-vaccine-distribution-.html https://biospectrumindia.com/news/22/17832/govt-seeks-startups-participation-for-effective-covid-19-vaccine-distribution-.html Thu, 24 Dec 2020 13:25:00 +0530 Ministry of Health and Family Welfare (MoHFW) along with Ministry of Electronics and Information Technology (MeitY) has announced the launching of ‘CoWIN’, a Grand Challenge for strengthening the COVID Vaccine Intelligence Network (CoWIN) system, a digitalised platform to be used to effectively roll out and scale up the mechanism for COVID Vaccine Distribution System, nationally. Ravi Shankar Prasad, Union Minister, Electronics and Information Technology, GoI said, “I invite innovators and start ups for grand challenge to strengthen CoWIN platform for roll out of COVID-19 vaccination programme across India.” To be launched on the MSH (MeitY Start-up Hub) portal, a collaborative platform developed under the aegis of MeitY towards building meaningful synergies in the Indian tech start-up space, the challenge invites participation from talented and innovative start-ups and emerging technology specialists to augment and scale the CoWIN platform. The Challenge kickstarted with registration process at https://meitystartuphub.in on December 23, 2020 and is open for participants to apply till January 15, 2021. The top 5 applicants will be provided the CoWIN APIs (Application Programming Interface) to prove the efficacy of their solutions for possible integration with the platform. Each shortlisted applicant at this stage stands a chance to win Rs 2 lakh covering their logistical requirements. The solutions once integrated with the platform through open APIs will be assessed for robustness and scalability. Top 2 contestants from the challenge will be rewarded with Rs 40 lakh and 20 lakh respectively. ]]> https://biospectrumindia.com/news/22/17830/health-ministry-issues-sop-in-context-to-new-uk-virus-strain.html https://biospectrumindia.com/news/22/17830/health-ministry-issues-sop-in-context-to-new-uk-virus-strain.html Wed, 23 Dec 2020 16:30:00 +0530 Ministry of Health has issued SOP for Epidemiological Surveillance and Response for people flying from the UK. The Standard Operating Procedure (SOP) describes the activities to be undertaken at the point of entry and in the community for all international passengers who have travelled from or transited through UK in the past 4 weeks (from November 25 to December 23, 2020). Any reference to testing in this SOP implies RT-PCR testing only. Passengers testing positive will be isolated in an institutional isolation facility in a separate (isolation) unit coordinated by the respective State Health Authorities. Necessary action to send the samples to National Institute of Virology (NIV), Pune or any other appropriate lab for genomic sequencing will be initiated at the facility level. If the genomic sequencing indicates the presence of new variant of SARS-CoV-2 then the patient will be kept in the separate isolation unit and treated as per the clinical protocol. Those who are found negative on testing with RT-PCR at the airport would be advised quarantine at home. Prior to check-in, the traveller will be explained about this SOP and in-flight announcements must also be made. International travellers from the UK who arrived in India since last one month will be contacted by District Surveillance Officers and monitored in community. State Governments/ Integrated Disease Surveillance Programme will ensure that all the contacts of those travellers from the UK or transiting through the UK in last four weeks will be traced and monitored. They will also be tested as per protocol.   ]]> https://biospectrumindia.com/news/22/17802/india-uk-to-accelerate-collaboration-on-vaccines-to-prevent-future-pandemics.html https://biospectrumindia.com/news/22/17802/india-uk-to-accelerate-collaboration-on-vaccines-to-prevent-future-pandemics.html Thu, 17 Dec 2020 18:15:00 +0530 Experts from India and the UK will join forces through a new virtual hub to deliver vaccines for coronavirus and other deadly viruses, the UK Foreign Secretary Dominic Raab announced in India on 16 December. The Foreign Secretary met Prime Minister Modi to discuss the UK and India working together as a force for good and launching the pioneering new vaccines hub which will share best practices for regulation and clinical trials, and foster innovation. He also visited a Delhi health clinic where Oxford/AstraZeneca vaccines will be administered. Serum Institute is poised to make over a billion doses of the coronavirus vaccine developed by Oxford University and AstraZeneca. Unlike other vaccines, it can be stored at normal fridge temperatures, making it easier and cheaper to produce and keep – and distribute around the world. Foreign Secretary Dominic Raab said: This Serum Institute and Oxford University partnership demonstrates the UK-India relationship at its best: a vaccine developed in the UK and made in India, drawing our brightest minds together to save lives as a global force for good. A global pandemic requires a global solution. Scientific cooperation has made breakthroughs on coronavirus vaccines at record-breaking pace and the UK-India Vaccine Hub will now build on these innovations, to bring this crisis to an end and protect us all against future pandemics. Millions of the doses made by the Serum Institute will be distributed to the world’s poorest people via the global COVAX initiative, in partnership with the World Health Organization (WHO) and Gavi, the vaccine alliance. India supplies more than 50% of the world’s vaccines and 25% of the NHS’s generic drugs. Closer UK-India cooperation on medicines and vaccines approvals will ensure speedy access for the UK to Indian-produced pharmaceuticals and help safeguard future supplies to the NHS. The new hub will enable British and Indian experts to share knowledge on clinical trials and regulatory approvals and get vaccines to people who need them most in a safe, secure and energy-efficient way. It will protect the UK and India by enhancing cooperation on the development and distribution of coronavirus vaccines, better aligning the international regulation of vaccines and fostering partnerships to develop innovation ‘moonshots’ that can define vaccine delivery over the next decade and beyond. ]]> https://biospectrumindia.com/news/22/17779/nathealth-africa-healthcare-federation-ink-mou-to-increase-healthcare-collaboration.html https://biospectrumindia.com/news/22/17779/nathealth-africa-healthcare-federation-ink-mou-to-increase-healthcare-collaboration.html Mon, 14 Dec 2020 21:00:00 +0530 NATHEALTH-Healthcare Federation of India and Africa Healthcare Federation (AHF) signed a path-breaking Memorandum of Understanding (MoU) to increase healthcare collaboration between the two federations with potential to result in increased investment and business in healthcare between India and Africa. The Summit theme, ‘Fostering South-South Collaboration between the Healthcare Federations of India and Africa to achieve Universal Health Coverage’ sends out an important message that collaboration is central to realising the goal of UHC and it is important that key stakeholders work together to build bridges across sectors and drive new initiatives to fix infrastructural gaps, improve health access and outcomes. In partnership with NATHEALTH, PwC India, launched its report titled, ‘Unlocking the potential of India-Africa collaboration for healthcare innovation’ at the event. The report highlights the importance of innovative healthcare approaches that can transform the traditional healthcare systems by ensuring quality healthcare, one that is accessible and affordable for all. The focus will be to bring transparency in referral mechanism/fees and the need of travel for treatment, for smooth VISA processing and Immigration. Establishing partnerships for diagnostic tests, emergency air evacuations will also be a priority. NATHEALTH and AHF will map skill transfer and training requirements to identify the key gaps that needs attention and look at the potential for e-learning and use of other technologies to bring down the costs. The two federations will identify gap areas by gauging industry interest on both ends for investments and categorise the ways and policy interventions needed to safeguard investor interests and highlight the alternate financing mechanisms available  Key focus areas also include addressing the need for harmonisation of regulatory requirements and building expertise for pharmaceutical manufacturing in GMP. The focus will also be on Increasing investment into R&D in Africa through collaborative research, twinning programmes that include galenic development, Centre of API manufacturing, etc.   The task force will consist of seven to nine members and will be jointly led by representatives from AHF and NATHEALTH. The members will include Industry partners, Development partners, Government representatives, Key experts in their individual capacity or as part of relevant institutions and Knowledge partners. Within the first quarter, each task force will be expected to present an Action Plan on their area detailing out the objectives and scope of thematic area, key outcomes expected at end of 1 year, policy areas to be covered and key stakeholders to be engaged. ]]> https://biospectrumindia.com/news/22/17770/dcgi-approves-indias-first-indigenous-mrna-vaccine-for-ph-i-ii-trial.html https://biospectrumindia.com/news/22/17770/dcgi-approves-indias-first-indigenous-mrna-vaccine-for-ph-i-ii-trial.html Mon, 14 Dec 2020 15:20:00 +0530 India’s first indigenous mRNA vaccine candidate has received approval from Indian drug regulators to initiate Phase I/II human clinical trial. The novel mRNA vaccine candidate, HGCO19 has been developed by Gennova, Pune and supported with seed grant under the Ind-CEPI mission of Department of Biotechnology. mRNA-based vaccines are scientifically the ideal choice to address a pandemic because of their rapid developmental timeline. The mRNA vaccine is considered safe as is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. They are expected to be highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm. Gennova, in collaboration with HDT Biotech Corporation, Seattle, USA, has worked together to develop an mRNA vaccine candidate. HGCO19 has already demonstrated safety, immunogenicity, neutralisation antibody activity in animals. The neutralising antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of COVID-19. Gennova’s vaccine candidate uses the most prominent mutant of spike protein (D614G) and also uses the self-amplifying mRNA platform, which gives the advantage of a low dosing regimen compared with the non-replicating mRNA or traditional vaccines. HGCO19 uses the adsorption chemistry so that the mRNA is attached on the surface of the nano-lipid carrier to enhance the release kinetics of the mRNA within the cells compared to the encapsulation chemistry. HGCO19 is stable at 2-8°C for two months. Gennova has completed all preliminary work and should be initiating the Phase I/II Human clinical trial soon since the approval from the DCGI office has been received.   ]]> https://biospectrumindia.com/news/22/17746/india-suriname-ink-mou-on-cooperation-in-health-medicine.html https://biospectrumindia.com/news/22/17746/india-suriname-ink-mou-on-cooperation-in-health-medicine.html Thu, 10 Dec 2020 00:00:00 +0530 The Union Cabinet, chaired by Prime Minister Narendra Modi, has given its approval for the Memorandum of Understanding between the Government of the Republic of India and the Ministry of Health of the Government of the Republic of Suriname, South America on cooperation in the field of health and medicine. The bilateral Memorandum of Understanding will encourage cooperation between the Ministry of Health and Family Welfare of the Republic of India and the Ministry of Health of the Government of the Republic of Suriname through joint initiatives and technology development in the health sector. It will strengthen bilateral ties between India and Suriname. It leads towards achieving Atmanirbhar Bharat (Self-Reliant India) by way of sharing of expertise in public health system, and by promoting mutual research in various relevant areas. The main areas of cooperation between the two Governments include the following: Exchange and training of medical doctors, officials, other health professionals and experts; Assistance in development of human resources and setting up of healthcare facilities; Short term training of human resources in health; Regulation of pharmaceuticals, medical devices and cosmetics and exchange of information thereon; Promotion of business development opportunities in pharmaceuticals; Procurement of generic and essential drugs and assistance in sourcing of drug supplies; Procurement of health equipment and pharmaceuticals products; Tobacco control; Promotion of mental health; Early detection and management of depression Digital health and Tele-medicine; and Any other area of cooperation as may be mutually decided upon. ]]> https://biospectrumindia.com/news/22/17743/ayush-ministry-aiims-to-set-up-department-of-integrative-medicine.html https://biospectrumindia.com/news/22/17743/ayush-ministry-aiims-to-set-up-department-of-integrative-medicine.html Wed, 09 Dec 2020 17:50:00 +0530 Ministry of AYUSH and AIIMS have decided to initiate work on setting up a Department of Integrative Medicine at AIIMS. This was decided in a joint visit and review by Vaidya Rajesh Kotecha, Secretary, AYUSH and Dr Randeep Guleria, Director, AIIMS of the Centre for Integrative Medicine and Research (CIMR) at AIIMS, New Delhi. The CIMR receives notable support through the Centre of Excellence Scheme of the Ministry of AYUSH. Dr Gautam Sharma, Head, CIMR and senior officers of AYUSH Ministry were also present during the visit. The cutting edge research activities being held by CIMR in the Yoga and Ayurveda disciplines were reviewed and the research outcomes were seen to be impressive. Ministry of AYUSH and AIIMS decided to extend the duration of the research collaboration at CIMR and also to extend the scope of collaborative activities. Considering the research work, other activities and accomplishments of CIMR, it was felt that setting up a dedicated OPD and IPD beds for CIMR could be the next steps in the growth and development of CIMR. Both Secretary AYUSH and Director AIIMS agreed that considering the increased interest of patients at AIIMS in the CIMR and the growing body of research work of the Centre it could be feasible to further develop it into a standalone Department for Integrative Medicine at AIIMS in the short-term future. This may be developed with dedicated faculty and staff to make it into a permanent Department at AIIMS. Secretary AYUSH assured that the Ministry of AYUSH will strive to continue its support to CIMR till the dedicated Department is developed. The notable research outcomes of CIMR and the encouraging results of the new initiatives in COVID-19 research through integrative research point towards an integrative approach being the need of the hour and towards the significant public health benefits it can lead to. It was decided that CIMR, AIIMS may develop an integrated protocol with Ayurveda and Yoga for study on Post COVID treatment. The Ministry of AYUSH could collaborate in the same through the Extra Mural Research Scheme. The progress in establishing the Integrated AYUSH cancer care facilities at the National Cancer Institute at Jhajjar, Haryana was also reviewed. It was decided to follow it up and expedite the process for early establishment and functioning of the centre. ]]> https://biospectrumindia.com/news/22/17736/nmcs-decision-to-reduce-number-of-non-mbbs-posts-sparks-fear-of-job-losses.html https://biospectrumindia.com/news/22/17736/nmcs-decision-to-reduce-number-of-non-mbbs-posts-sparks-fear-of-job-losses.html Tue, 08 Dec 2020 18:45:00 +0530 The National Medical Commission (NMC) recent decision to reduce the number of posts for non-MBBS teachers in medical institutions has sparked fear of job losses among currently employed teachers. According to the website of the Medical Council of India (MCI), which was recently replaced by NMC, in 2017, around 13% of the teaching faculty in medical colleges are 'non-medical' degree holders. In a statement protesting this decision by the NMC, Dr Sridhar Rao, President, National MSc Medical Teachers' Association (NMMTA) pointed out that in the “Minimum Requirements for MBBS Admission Regulations 2020” released by the newly established medical education regulator last month, the permissible intake of non-medical faculty has come down from 30% to 15% in anatomy and physiology, from 50% to 15% in biochemistry, and from 30% to 0% in microbiology and pharmacology. Dr Rao said, “India's clinical scientists with medical MSc postgraduate degrees are now facing an existential crisis of the highest magnitude. A hostile MCI turned NMC and an indifferent government that is rife with policy paralysis are making matters worse. Those pursuing medical MSc courses in medical colleges are trained and skilled to render their services as consultants in diagnostic laboratories, teachers in the non-clinical disciplines of the medical curriculum and scientists in research establishments.” The teachers have accused the Union Ministry of Human Resource Development (MHRD) and the Ministry of Health and Family Welfare (MoHFW) of not displaying any interest in dealing with the crisis being faced by the non-MBBS teachers. NMMTA said, “This policy paralysis has existed since several decades with no interest among successive governments to address the issue.” It added, “The medical colleges and universities that have conducted these courses for years/decades and profited from such courses have never stood up for their alumni and have not supported the roles played by the medical MSc person,” and pointed out that the present and future of the clinical scientists with medical MSc qualifications in teaching, laboratory diagnostics and research are uncertain.  "We are wrongly called non-medical teachers; we have been awarded Medical MSc degrees under the faculty of Medicine by the health universities", said Arjun Maitra, General Secretary, NMMTA. "Instead of shunting us out, there must be more efforts to train and integrate us. We can consult the clinical colleagues for inputs on the horizontal and vertical integrations,” added Dr Rao. ]]> https://biospectrumindia.com/news/22/17720/govt-to-set-up-ayush-export-promotion-council-.html https://biospectrumindia.com/news/22/17720/govt-to-set-up-ayush-export-promotion-council-.html Mon, 07 Dec 2020 16:00:00 +0530 The Ministry of Commerce and Industry and the Ministry of AYUSH have decided to work together to set up an Export Promotion Council to boost AYUSH exports. This decision was taken recently in a joint review of AYUSH trade and Industry by Piyush Goyal, Minister of Commerce and Industry and Shripad Naik, Minister of AYUSH. It was also decided in the review that the entire AYUSH sector will work together to achieve price and quality competitiveness to boost AYUSH exports. The review was held through video conference on December 4, 2020, which was attended by nearly 50 industry and trade leaders from the AYUSH Sector. More than 2000 stake-holders of the AYUSH Sector also attended the e-event through live streaming on virtual platforms. Secretary AYUSH spoke about the emerging opportunities for promotion of AYUSH sector and listed a few hurdles that deserved attention. In the open forum that followed, officials from Ministry of Commerce and Industry, RIS, BIS and Invest India and AYUSH industry representatives shared their thoughts. Naik stated that trade and commerce in the AYUSH Sector needed to upscale quickly in order to meet the growing demands from India and abroad, and to serve the larger number of people who are now looking up to these systems for maintaining their health. The Commerce Minister advised the industry leaders to work simultaneously on the quality and pricing of their products, so that they become increasingly competitive in the global market. He supported the concept of an AYUSH Export Promotion Council and said that the Commerce Ministry would be happy to support the same. The following are the action points that emerged from the meeting: Ministry of AYUSH and Ministry of Commerce and Industry will work together for establishing an AYUSH Export Promotion Council (AEPC). The proposed AEPC can be housed at Ministry of AYUSH. Standardisation of HS code for AYUSH will be expedited. Ministry of AYUSH will work in collaboration with Bureau of Indian standards to develop international standards for AYUSH products as well as services. Ministry of AYUSH and AYUSH industry will identify best practices/ success stories and promote them amongst the public. AYUSH industry will work on ensuring quality and standards of AYUSH products as well as to become price-competitive. AYUSH will figure in the Brand India activities. ]]> https://biospectrumindia.com/news/22/17715/govt-developing-comprehensive-vaccination-strategy.html https://biospectrumindia.com/news/22/17715/govt-developing-comprehensive-vaccination-strategy.html Fri, 04 Dec 2020 17:30:00 +0530 Prime Minister Narendra Modi participated in the All Party Meeting held on 4 December via video conferencing to discuss the COVID-19 vaccination strategy in India. The Prime Minister said that the government is developing a comprehensive vaccination strategy. He emphasised that the world is looking towards India for the development of a safe and affordable vaccine. Modi shared his experience of visiting the vaccine manufacturing facilities in Ahmedabad, Pune, and Hyderabad, informing that about eight potential vaccines, currently in different stages of trial, will be manufactured in India, that includes the three indigenous vaccines. He said that it is expected that the vaccine will be available in the coming few weeks. The vaccination campaign will kickstart in India as soon as the vaccine is approved by the scientists. The Central government is working in close coordination with the State governments to identify the priority groups for vaccination. Underlining India's vaccine distribution expertise, capacity and presence of an experienced and vast network for vaccination, the Prime Minister said that this will help us in streamlining Covid vaccination. Collaboration with State Governments will be established for additional cold chain equipment and other such logistical requirements. A National Expert Group that includes technical experts and officials of both the Central Government and State Governments, has been constituted to shoulder the responsibility of the campaign related to the vaccine. The National Expert Group will take decisions collectively as per national and regional requirements. Political parties that participated in the meeting included the Indian National Congress, Trinamool Congress, DMK, YSR Congress Party, JD(U), BJD, Shiv Sena, TRS, BSP, SP, AIADMK and BJP. The leaders assured the Prime Minister of their full support to ensure efficient and speedy vaccination. ]]> https://biospectrumindia.com/news/22/17661/india-is-looking-to-be-self-reliant-in-mass-production-of-covid-19-vaccine.html https://biospectrumindia.com/news/22/17661/india-is-looking-to-be-self-reliant-in-mass-production-of-covid-19-vaccine.html Thu, 26 Nov 2020 13:30:00 +0530 Dr Harsh Vardhan, Minister of Health and Family Welfare, Govt of India said that as the world races to find a cure and vaccine for COVID-19, India is looking to be self-reliant in both development of the vaccine and its mass production.  Addressing the virtual Global R&D Summit 2020, organised by FICCI, jointly with the DST, Govt of India, from 25 to 27 November, Dr Vardhan said, "Called as the 'pharmacy of the world', India has the largest capacity to produce COVID-19 vaccines. We have now started to look at a robust vaccine manufacturing and delivery ecosystem to meet our demands in the coming days."  He further stated that it is time for bold decisions and bold investments, and not for conservative approaches. "We are committed to help companies invest in India and make for India and for the World," he added.  Zunaid Ahmed Palak, State Minister, ICT Division, Ministry of Post, Telecommunications and IT, Govt of Bangladesh said, “This is not the time to compete but rather to collaborate, to build a better world together."  Dr Sangita Reddy, President, FICCI said that the COVID-19 outbreak has emphasised the need for the nations to be self-reliant, and to embrace multilateral inclusive growth of a sustainable and inclusive nature where we leave no one behind. Sanjay Nayak, Chair, FICCI Science, Technology & Innovation Committee and CEO & MD, Tejas Networks said that a robust research and development ecosystem is essential for any nation as it will have a long-lasting financial impact on businesses. Dr Desh Deshpande, Board Member, MIT Corporation, Co-Chairman, President Obama's National Advisory Council on Innovation and Entrepreneurship and President & Chairman, Sparta Group LLC said that unless we create a virtual cycle where innovation has a social and economic impact on the society, the society would not be able to feedback into the innovation cycle. ]]> https://biospectrumindia.com/news/22/17658/niti-aayog-releases-compendium-for-covid-19-management.html https://biospectrumindia.com/news/22/17658/niti-aayog-releases-compendium-for-covid-19-management.html Wed, 25 Nov 2020 19:20:00 +0530 NITI Aayog has recently released a compendium of practices from states and union territories that details information about various initiatives implemented by states, districts, and cities in India for containing and managing the Covid-19 outbreak. The compendium was released by NITI Aayog Member Dr VK Paul, CEO Amitabh Kant and Additional Secretary Dr Rakesh Sarwal. In preparing the compendium of practices, NITI Aayog reached out to all states and union territories by email and telephonically, requesting them to share any practices that they believe had been useful for Covid-19 mitigation and management. Additional information was provided by some states during review meetings with Member (Health), NITI Aayog. Sourcing of information directly from states/UTs was supplemented with a comprehensive literature review. The practices in the compendium have been disaggregated under six sections: (i) public health and clinical response (ii) governance mechanisms (iii) digital health (iv) integrated model (v) welfare of migrants and other vulnerable groups (vi) other practices. A summary of the relevant Government of India guidelines has been included for theaforementioned categories, wherever applicable. Practices adopted by states/UTs in the fight against Covid-19 range from the preparation of comprehensive route maps for contact tracing to the operationalization of mobile vans for testing and providing essential health services to the doorsteps of people. Technology has been leveraged extensively by several states and UTs,including the use of robots for delivering food, water, and medicines to patients in hospitals as well as training health personnel using virtual platforms.   ]]> https://biospectrumindia.com/news/22/17618/health-minister-reiterates-commitment-to-end-aids-by-2030.html https://biospectrumindia.com/news/22/17618/health-minister-reiterates-commitment-to-end-aids-by-2030.html Wed, 18 Nov 2020 18:05:00 +0530 Dr Harsh Vardhan, Union Minister for Health and Family Welfare digitally addressed the Ministerial meeting of the Global Prevention Coalition (GPC) for HIV Prevention on 18 November. Hosted by UNAIDS and UNFPA on behalf of the Global HIV Prevention Coalition (GPC),the conference this year holds significance in achieving the 2016 UNGA commitment to end AIDS by 2030. Member States of GPC had agreed to reduce new adult HIV infections by 75 per cent at the end of 2020 from 2010 levels. Speaking on India’s unique HIV prevention model which is centred around the concept of ‘Social Contracting’ through which the Targeted Interventions (TI) programme is implemented, the Union Health Minister remarked. Dr Harsh Vardhan elaborated how India protected the gains made in HIV prevention during the COVID-19 pandemic. “The Government linked key populations and PLHIV to various social welfare schemes. Advisories and guidance notes were issued by NACO from time to time aligned with global guidelines in the context”, he stated. The Union Health Minister apprised the audience how India had revamped its Targeted Intervention (TI) programme to focus on hard-to-reach populations to keep its commitments- People living in prisons and other closed settings were considered as priority populations and interventions launched were gradually scaled up since 2016; the HIV Counselling & Testing Services (HCTS), Community based Screening of HIV for improving early diagnosis were also ramped up; the coverage of testing for HIV across the country was increased to achieve the Elimination of Mother to Child Transmission of HIV. In this regard, he also mentioned the enactment of The Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017 which has provided a legal and enabling framework for safeguarding the human rights of the infected and affected populations. He ended his speech by reiterating India’s commitment to achieve the 90-90-90 targets across the country by the end of the current year and also end the AIDS epidemic as a public health threat by 2030. ]]> https://biospectrumindia.com/news/22/17564/karnataka-govt-joins-hands-with-indiana-to-work-on-medical-devices.html https://biospectrumindia.com/news/22/17564/karnataka-govt-joins-hands-with-indiana-to-work-on-medical-devices.html Mon, 09 Nov 2020 00:00:00 +0530 More than 25 countries have confirmed participation in the flagship technology conference of Government of Karnataka  – Bengaluru Tech Summit 2020 which will be held virtually for the first time from 19th to 21st November, 2020. Government of Karnataka has embarked on developing “Global Innovation Alliances (GIA)” with innovation hubs of the world, through which there are ongoing engagements with over 20 countries on a regular basis. The engagements range from G2G meetings and MoUs, to active projects for skilling, R&D and startup cooperation. Partner countries like Australia, France, Germany, Israel, Netherlands , Switzerland and UK, among others, will play a key role in showcasing advancements made in technology and how future ready their innovations are through the GIA sessions platform. This year, Government of Karnataka is expected to sign over 7 MoUs with GIA partner institutions for cooperation in startups, research & development and skilling, out of which 7 will be signed at Bengaluru Tech Summit. Department of Electronics IT Bt and S&T and the Department of Commerce and Industry have jointly decided to sign an MoU with Indiana Economic Development to work on projects in Electric Vehicles and Medical Devices/Healthcare. The MoU will be signed for a period of 5 years. In addition, the MoU between Center for Excellence of Data Science and Artificial Intelligence (AI), Karnataka and Business Finland will focus on bi-lateral market access for startups, joint research program for societal good and mutual student and faculty exchange program. The Center of Excellence for Agri Innovation housed at the Centre for Cellular and Molecular Platforms (C-CAMP) has agreed to sign an MoU with the World Startup Factory in the Netherlands, where the main area of focus will be a virtual market access program for the growth stage startups to explore global markets. The MoU will also chart deliverables regarding mentorship connects and mutual industry facilitation.  Speaking at an event on Bengaluru Tech Summit 2020 and Global Innovation Alliance (GIA), Dr CN Ashwath Narayan, Deputy Chief Minister of Karnataka, and Minister for IT, Bt and S&T said, “We are now working at global level, through exchange of people and ideas, so that Karnataka may consistently maintain its lead position in innovation, science and technology. Hence, Department of Electronics, IT, BT and S&T has embarked on developing “Global Innovation Alliances (GIAs)” with innovation hubs of the world. I am certain that the participation of our GIA Partner Countries at BTS 2020 will enhance the event in a big way and create meaningful and long term international partnerships in the coming days.” ]]> https://biospectrumindia.com/news/22/17536/cabinet-approves-mou-with-israel-on-health-medicine.html https://biospectrumindia.com/news/22/17536/cabinet-approves-mou-with-israel-on-health-medicine.html Thu, 05 Nov 2020 00:00:00 +0530 The Union Cabinet chaired by the Prime Minister Narendra Modi has approved the signing of the Memorandum of Understanding (MoU) between India and Israel on cooperation in the field of health and medicine. The MoU covers the following areas of cooperation: Exchange and training of medical doctors and other health professionals; Assistance in development of human resources and setting up of healthcare facilities; Exchange of information regarding regulation of pharmaceutical, medical devices and cosmetics; Sharing expertise for vulnerability assessment for health of citizens against climate risk and public health actions targeted towards mitigation and adaptation; Sharing of expertise for facilitating climate resilient infrastructure as well as providing support for development of 'Green Healthcare' (climate resilient hospitals); Promote mutual research in various relevant areas; and Any other area of cooperation as may be mutually decided upon. Each Party shall encourage the participation of the representatives of their countries in round tables, seminars, symposia, workshops and conferences on issues of cooperation, organised by the other Party's relevant bodies. ]]> https://biospectrumindia.com/news/22/17535/cabinet-approves-mou-with-uk-for-medical-product-regulation.html https://biospectrumindia.com/news/22/17535/cabinet-approves-mou-with-uk-for-medical-product-regulation.html Wed, 04 Nov 2020 18:05:00 +0530 The Union Cabinet, chaired by the Prime Minister Narendra Modi, has given its approval for signing a Memorandum of Understanding (MoU) between the Central Drugs Standard Control Organisation (CDSCO), India and the United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA) on cooperation in the field of medical product regulation. The MoU will help in establishing a framework for fruitful cooperation and exchange of information between CDSCO and UK MHRA of United Kingdom in matters relating to Medical products regulation in line with their international responsibilities. The main areas of cooperation between the two regulatory authorities include the following: a) Exchange of safety information, including Pharmacovigilance where there is a particular safety concern related to the other party. This includes safety concerns relating to medicines and medical devices. b) Participation in scientific and practical conferences, symposia, seminars and fora organised by India and the United Kingdom. c) Exchange of information and cooperation on Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Good Pharmacovigilance Practices (GPvP). d) Capacity building in mutually agreed areas. e) Promote an understanding between the Parties of each other's regulatory framework, requirements and processes; and to facilitate future regulatory strengthening initiatives for both Parties. f) Exchange of information on laws and regulations regarding medicines and medical devices. g) Information exchange to support efforts to control unlicensed exports and imports. h) Coordination at the international fora. It would facilitate better understanding of the regulatory aspects between the two sides and could help in increased cooperation in the field of medical products regulation and better coordination in international fora. ]]> https://biospectrumindia.com/news/22/17526/dbt-launches-joint-funding-initiative-with-uk-for-covid-19-research.html https://biospectrumindia.com/news/22/17526/dbt-launches-joint-funding-initiative-with-uk-for-covid-19-research.html Wed, 04 Nov 2020 00:00:00 +0530 UK Research and Innovation (UKRI) and the Department of Biotechnology (DBT),Ministry of Science and Technology, Govt. of India are launching a joint funding initiative to support collaborative research focused on understanding the severity of COVID-19 in South Asian populations in India and the UK. Since the start of COVID-19 pandemic, DBT and UKRI have made significant rapid investment in COVID19 research.Building on this strong base, through the Medical Research Council (MRC) and Economic and Social Research Council (ESRC) UKRI is investing £4 million to support the UK component, with matched equivalent resource provided by DBT in support of the Indian components. This joint funding opportunity will support new research projects that are trying to understand, the pandemic through the study of related ethnic groups in different environments in both countries. Successful projects will focus on:  Mechanistic studies of the disease and its sequelae  Virology, Immunity and Pathophysiology  Epidemiology and behavioural science Dr Renu Swarup, Secretary of India’s Department of Biotechnology said: This joint programme builds on the strong foundation of India-UK research collaboration and is an opportunity to bring together our collective expertise to understand the severity of COVID-19 infection in South Asian populations of both India and the UK. This pandemic has brought together scientific research groups nationally and globally to address key research questions. Faced with one of the biggest challenges of our time, research from this DBT-UKRI collaboration will be important in understanding the differential response among these two populations. Improved understanding in this regard will empower us in planning more effective interventions to fight COVID-19 pandemic and any such events in future. ]]> https://biospectrumindia.com/news/22/17519/govt-revises-pli-schemes-for-promoting-domestic-manufacturing-of-bulk-drugs-medical-devices.html https://biospectrumindia.com/news/22/17519/govt-revises-pli-schemes-for-promoting-domestic-manufacturing-of-bulk-drugs-medical-devices.html Tue, 03 Nov 2020 00:00:00 +0530 The Union Department of Pharmaceuticals, Ministry of Chemicals and fertilizers has revised the Production Linked Incentive (PLI) Schemes for promoting domestic manufacturing of bulk drugs and medical devices keeping in view the suggestions and comments received from the industry. Accordingly ‘minimum threshold’ investment requirement has been replaced by ‘committed investment’ taking into account availability of technology choices which varies from product to product. Post issuance of the detailed guidelines, the department received several suggestions and inputs from the pharmaceutical and medical device industry seeking certain amendments in the scheme to enable effective participation of the industry in the two schemes. The suggestions were examined by the respective Technical Committees formed under the schemes. The main changes which have been effected in the revised guidelines for Production Linked Incentive (PLI) scheme for promotion of domestic manufacturing of critical Key Starting Materials, Drug Intermediates and Active Pharmaceutical Ingredients in India are as follows: Replacement of the criteria of ‘minimum threshold’ investment with ‘committed’ investment by the selected applicant. The change has been made to encourage efficient use of productive capital as the amount of investment required to achieve a particular level of production depends upon choice of technology and it also varies from product to product. The provision for verification of the actual investment made by the selected applicant for the purpose of giving incentives under the scheme continues. Deletion of the provision which restricts the sales of eligible products to domestic sales only, for the purpose of eligibility of receiving incentives, bringing the scheme in line with other PLI schemes and encouraging market diversification. Change in the minimum annual production capacity for 10 products viz Tetracycline, Neomycin, Para Amino Phenol (PAP), Meropenem, Artesunate, Losartan, Telmisartan, Acyclovir, Ciprofloxacin and Aspirin. Minimum annual production capacity is a part of eligibility criteria under the scheme. The last date for receiving applications under the scheme is now extended by a week to 30.11.2020 (inclusive) Similarly, the main changes which have been effected in the revised guidelines for Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices are as follows- Replacement of the criteria of ‘minimum threshold’ investment with ‘committed’ investment by the selected applicant. The change has been made to encourage efficient use of productive capital as the amount of investment required to achieve a particular level of production depends upon technology used and it also varies from product to product. The provision for verification of the actual investment made by the selected applicant for the purpose of giving incentives under the scheme continues. Change in the eligibility criteria of minimum sales threshold in line with projected demand, technology trend and market development, for the purpose of availing incentive under the scheme. The tenure of the scheme has been extended by one year keeping in view the capital expenditure expected to be done by the selected applicants in FY 2021-22. Accordingly, the sales for the purpose of availing incentives will be accounted for 5 years starting from FY 2022-2023 instead of FY 2021-2022. The last date for receiving applications under the scheme is now extended by a week to 30.11.2020 (inclusive). ]]> https://biospectrumindia.com/news/22/17506/ayush-ministry-to-set-up-5-incubation-centres-in-coming-months.html https://biospectrumindia.com/news/22/17506/ayush-ministry-to-set-up-5-incubation-centres-in-coming-months.html Fri, 30 Oct 2020 16:20:00 +0530 To promote the Indian Ayush industry nationally and globally, ASSOCHAM has partnered with the Ministry of Ayush, Government of India to organize ‘Global Ayush Mela’, a three-day virtual expo to provide a platform for various stakeholders to network, encourage education and honor the leaders of the industry. The virtual expo opened on 30 October. A knowledge report titled ‘Medicinal plants for rural development for North East’ compiled by ASSOCHAM was released by Dr Jitendra Singh, Minister of State, Prime Minister’s Office and MoS (I/C), Ministry of Development of North Eastern Region, Government of India, who was the Chief Guest at the inaugural session. Speaking at the event, Rajesh Kotecha, Secretary, Ministry of AYUSH said, “Global disruptions due to the pandemic has opened avenues for the deep-rooted ancient knowledge and treasure trove of medicinal plants used in the Ayush system of treatment as an answer to the challenge of Covid. India’s stronghold in the field of Ayurvedic immunity-boosting practices puts us in a strong position to meet present and future demands. The government has been championing the growth of this sunrise industry through various schemes and 4000 crores have been announced for the Ayush Sector exclusively for medicinal plants under the Atmanirbhar Abhiyaan.” He further added, “10 lakh hectare cultivation of medicinal plants will soon be a reality and there will be startup incubation centres to aid the growth of the Ayush sector. Five such incubation centres will come in the country in the next six months. Also, 68 research studies are being done all over the country in this field. All these show the commitment of the ministry and the government towards giving the filed its rightful place. With the rising interest in Ayush, now is the time for all stakeholders including private players to work together towards a shared common dream that is the growth Ayush in the country and beyond.”  Acharya Balkrishna, Vice-Chancellor, University of Patanjali said, “There were many preconceived notions about Ayurved and yoga before Corona but this pandemic gave us an opportunity to dispel them and showcase to all that they can play a big role especially in the prevention of diseases like these. We faced several problems but today we are directly involved with more than one crore family and have reached to more than 50 crore people overall in various ways. These are all established things so I request all to get out maximum benefit from our traditional knowledge and medicines.” He added, “Now people have also accepted Coronil as preventive medicine and as a Suraksha Kawach. I am happy to share that the well known Molecules international journal has accepted the Coronil research work and will be publishing on their website in a day or two. This will lead to more acceptance of not only Coronil but also the extensive research work that went behind it.”    ]]> https://biospectrumindia.com/news/22/17501/cabinet-approves-mou-between-india-and-cambodia-for-health-and-medicine.html https://biospectrumindia.com/news/22/17501/cabinet-approves-mou-between-india-and-cambodia-for-health-and-medicine.html Fri, 30 Oct 2020 00:00:00 +0530 The Union Cabinet chaired by the Prime Minister, Narendra Modi has approved the signing of the Memorandum of Understanding (MoU) between India and Cambodia on cooperation in the field of Health and Medicine. The bilateral MoU will encourage cooperation between the two countries through joint initiatives and technology development n the health sector.  It will strengthen bilateral ties between India and Cambodia.  The MoU shall become effective on the date of its signature and shall remain in force for a period of five years. The main areas of cooperation between the two Governments include:  Mother and child health; Family Planning; HIV/AIDS and TB; Drugs and Pharmaceuticals; Technology Transfer; Public Health and Epidemiology; Disease Control (Communicable and Non-Communicable); Medical Research and Development, subject to the approval of the National Ethic Committee of Cambodia and to the clearance by concerned Department/Ministry in India; Medical Education; Health manpower development in the field of public health; Training in clinical, para-clinical and management skills; and Any other area of cooperation as may be mutually decided upon. ]]> https://biospectrumindia.com/news/22/17491/health-ministry-seeking-solutions-for-management-of-biomedical-waste.html https://biospectrumindia.com/news/22/17491/health-ministry-seeking-solutions-for-management-of-biomedical-waste.html Thu, 29 Oct 2020 00:00:00 +0530 The Union Minister of Health and Family Welfare, Science & Technology and Earth Sciences, Dr Harsh Vardhan has underlined the need for long term solutions for management of biomedical waste so as to ease the pressure on Health and Environment, specifically in a pandemic like situation. His message was read out at a recent webinar. “The need for biomedical waste management is quite significant today, there is a need for strict compliance of the rules and regulations already in place for safe disposal of such biomedical waste”, he added while thanking India Water Foundation (IWF) and United Nations Environment Programme (UNEP) for supporting member states, including India, through an environmental strategy to protect people. The high-level webinar on ‘The Future of Liquid Waste Management amidst COVID-19: What lies ahead?’ was jointly organized by the India Water Foundation (IWF) and United Nations Environment Programme (UNEP) supported by the Department of Science & Technology (DST), Government of India and Department of Drinking Water and Sanitation, Ministry of Jal Shakti recently. The webinar focused on the future of liquid waste management and effective management of biomedical waste.  The main objective was to have a holistic understanding on various facets of waste management in context of COVID-19 along with socio-environmental impacts. The sudden onset of the COVID-19 pandemic in early 2020 has imposed massive health and economic burdens on communities around the world and affected every sector of society, including the waste-water sector. Among all the categories of biomedical waste, liquid wastes pose a serious threat to human health and the environment because of their ability to enter watersheds, pollute groundwater and drinking water when improperly handled and disposed. Professor Ashutosh Sharma, Secretary, DST, highlighted about innovations to tackle this waste that have been developed in the last 4-5 months like garbage bins with virus neutralizing inner lining for hospitals by institutions like Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum. They are now being produced commercially. ]]> https://biospectrumindia.com/news/22/17462/nppa-sets-up-price-monitoring-unit-in-goa.html https://biospectrumindia.com/news/22/17462/nppa-sets-up-price-monitoring-unit-in-goa.html Mon, 26 Oct 2020 02:10:00 +0530 A Price Monitoring and Resource Unit (PMRU) has been set up in Goa under the aegis of National Pharmaceutical Pricing Authority (NPPA), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India.           NPPA, in coordination with Goa State Drug Control Department has set up a Price Monitoring and Resource Unit that will function at the State level under the direct supervision of the State Drug Controller for increasing outreach of NPPA. PMRUs are societies registered under the Societies Registration Act having its own Memorandum of Association/ Bye laws. The Board of Governors of PMRU includes the representatives from Central Government and State Government concerned and other stakeholders. NPPA, under its Central Sector Scheme named Consumer Awareness, Publicity and Price Monitoring (CAPPM) has already   set up PMRUs in 15 States/ UTs, viz., Kerala, Odisha, Gujarat, Rajasthan, Haryana, Nagaland, Tripura, Uttar Pradesh, Punjab, Andhra Pradesh, Mizoram, Jammu & Kashmir, Karnataka, Telangana and Maharashtra.  NPPA has plans to set up PMRUs in all the 36 States/ UTs in the country.  The expenses of PMRUs, both recurring and non-recurring are borne by NPPA under the Scheme. Till now NPPA is headquartered at Delhi and with the setting up of PMRUs in States/ UTs, NPPA shall have outreach at State Level as well. The PMRUs are expected to strengthen drug security and affordability at regional levels.  The primary function of PMRUs is to assist NPPA in monitoring of prices of drugs, ensuring availability of drugs and raising consumer awareness. They act as collaborating partners of NPPA with information gathering mechanism at the grass-roots level. They will render necessary technical assistance to both the NPPA and the respective State Drug Controllers of States/ Union Territories. ]]> https://biospectrumindia.com/news/22/17430/health-ministry-unveils-website-on-repurposed-drugs-for-covid-19.html https://biospectrumindia.com/news/22/17430/health-ministry-unveils-website-on-repurposed-drugs-for-covid-19.html Wed, 21 Oct 2020 00:00:00 +0530 Dr Harsh Vardhan, Minister of Science & Technology, Health and Family Welfare and Earth Sciences, has launched a website that gives comprehensive information about the numerous COVID-19 clinical trials that CSIR is engaged in partnership with Industry, other government departments and ministries. Called CuRED or CSIR Ushered Repurposed Drugs, the website provides information about the drugs, diagnostics and devices including the current stage of the trials, partnering institutions and their role in the trials and other details. The site can be accessed at https://www.iiim.res.in/cured/      or http://db.iiim.res.in/ct/index.php. CSIR is exploring multiple combination clinical trials of anti-virals with host-directed therapies for the potential treatment of COVID-19. CSIR is also working with the Ministry of AYUSH for clinical trials of AYUSH drugs and has undertaken safety & efficacy trials of AYUSH prophylactics and therapeutics based on individual plant-based compounds and in combination. Five clinical trials involving Withaniasomnifera, Tinosporacordifolia + Piper longum(in combination), Glycyrrhizaglabra, Tinosporacordifolia & Adhatodavasica (individually and in combination) and AYUSH-64 formulation are undergoing safety and efficacy trials. A key clinical trial of CSIR is the Sepsivac (Mw) against COVID -19 in partnership with Cadila. The phase 2 clinical trial has been completed successfully on critically ill COVID-19 patients, and more extensive Phase 3 trial is on the anvil. Further, the Phase 2 trial of phytopharmaceutical AQCH on Covid-19 patients with Sun Pharma and DBT is underway. In addition to clinical trials of repurposed drugs and vaccines, CSIR has been involved in clinical trials of diagnostics and devices.  ]]> https://biospectrumindia.com/news/22/17419/ncdc-launches-ayushman-sahakar-scheme-to-assist-cooperatives-in-creation-of-healthcare-infrastructure.html https://biospectrumindia.com/news/22/17419/ncdc-launches-ayushman-sahakar-scheme-to-assist-cooperatives-in-creation-of-healthcare-infrastructure.html Tue, 20 Oct 2020 10:55:00 +0530 Parshottam Rupala, Union Minister of State for Agriculture launched Ayushman Sahakar, a unique scheme to assist cooperatives play an important role in creation of healthcare infrastructure in the country formulated by the apex autonomous development finance institution under the Ministry of Agriculture and Farmers Welfare, the National Cooperative Development Corporation (NCDC). Rupala announced that NCDC would extend term loans to prospective cooperatives to the tune of Rs 10,000 crore in the coming years. He said that the ongoing pandemic has brought into focus the requirement of creation of more facilities. NCDC’s scheme will be a step towards strengthening farmers welfare activities by the Central Government. Rupala said that Ayushman Sahakar scheme would revolutionise the way healthcare delivery takes place in rural areas. He also gave a call to existing cooperatives take up healthcare services as an activity for farmers. Sundeep Nayak, MD, NCDC added that there are about 52 hospitals across the country run by cooperatives. They have cumulative bed strength of more than 5,000. The NCDC fund would give a boost to provision of healthcare services by cooperatives. NCDC’s scheme aligns itself with the focus of the National Health Policy, 2017, covering the health systems in all their dimensions- investments in health, organisation of healthcare services, access to technologies, development of human resources, encouragement of medical pluralism, affordable health care to farmers etc. It has a comprehensive approach-hospitals, healthcare, medical education, nursing education, paramedical education, health insurance and holistic health systems such as AYUSH. Ayushman Sahakar scheme fund would also assist cooperative hospitals take up medical / Ayush education. Any Cooperative Society with suitable provision in its bye laws to undertake healthcare related activities would be able to access the NCDC fund. NCDC assistance will flow either through the State Governments/ UT Administrations or directly to the eligible cooperatives. Subsidy/ grant from other sources can be dovetailed. Ayushman Sahakar specifically covers establishment, modernisation, expansion, repairs, renovation of hospital and healthcare and education infrastructure.  The scheme also provides working capital and margin money to meet operational requirements. The scheme provides interest subvention of 1 per cent to women majority cooperatives.     ]]> https://biospectrumindia.com/news/22/17415/govt-unveils-fund-of-rs-10000-cr-to-create-healthcare-infrastructure-by-cooperatives.html https://biospectrumindia.com/news/22/17415/govt-unveils-fund-of-rs-10000-cr-to-create-healthcare-infrastructure-by-cooperatives.html Tue, 20 Oct 2020 00:00:00 +0530 Union Minister of State for Agriculture Parshottam Rupala has launched AYUSHMAN SAHAKAR, a unique scheme to assist cooperatives play an important role in creation of healthcare infrastructure in the country formulated by the apex autonomous development finance institution under the Ministry of Agriculture and Farmers Welfare, the National Cooperative Development Corporation (NCDC). Rupala announced that NCDC would extend term loans to prospective cooperatives to the tune of Rs.10,000 Crore in the coming years. He said that the ongoing pandemic has brought into focus the requirement of creation of more facilities. NCDC’s scheme will be a step towards strengthening farmers welfare activities by the Central Government. Rupala said that AYUSHMAN SAHAKAR scheme would revolutionize the way healthcare delivery takes place in rural areas. He also gave a call to existing cooperatives take up healthcare services as an activity for farmers. Sundeep Nayak, MD, NCDC added that there are about 52 hospitals across the country run by cooperatives. They have cumulative bed strength of more than 5,000. The NCDC fund would give a boost to provision of healthcare services by cooperatives. Ayushman Sahakar specifically covers establishment, modernization, expansion, repairs, renovation of hospital and healthcare and education infrastructure encompassing:   Hospitals and/ or Medical/ AYUSH/ Dental/ Nursing/ Pharmacy/ Paramedical/ Physiotherapy Colleges for running UG and /or PG programmes,          Yoga Wellness Centre, Ayurveda, Allopathy, Unani, Siddha, Homeopathy and other traditional medicine healthcare centres, Health care services for elderly, Palliative care services, Health care services for Persons with Disabilities, Mental healthcare services, Emergency Medical Services / Trauma Centre, Physiotherapy centre, Mobile Clinic Services, Health Club and Gym, AYUSH pharmaceutical manufacturing, Drug testing laboratory, Dental care centre, Ophthalmic care centre, Laboratory services, Diagnostics services, Blood Bank / transfusion services, Panchkarma/ Thokkanam/ Kshar sutra therapy centre, Regimental Therapy of Unani (Ilaj Bil Tadbeer) centre, Maternal health and Childcare services, Reproductive and Child Health services, Any other related centre or services as may be deemed fit by NCDC for assistance, Telemedicine and remote assisted medical procedures, Logistics health, healthcare and education, Information and Communication Technology related to digital health, Health insurance accredited by Insurance Regulatory and Development Authority (IRDA). ]]> https://biospectrumindia.com/news/22/17404/govt-makes-st-infrastructure-more-accessible-to-industry-startups.html https://biospectrumindia.com/news/22/17404/govt-makes-st-infrastructure-more-accessible-to-industry-startups.html Mon, 19 Oct 2020 01:05:00 +0530 Startups and industries will soon have access to equipment and Science & Technology (S&T) infrastructure in different institutions, universities, and colleges spread all over the country to carry out experiments and tests they require for their R&D, technology, and product development. The Department of Science & Technology (DST) is restructuring its FIST (Fund for Improvement of S&T Infrastructure in Universities and Higher Educational institutions) programme under which it supports scaling up ofthe network ofinfrastructural facilities for teaching and research in Universities and higher educational institutions to cater to high-end S&T infrastructural requirements of startups and industries. “The immensely successful FIST programme will now be reinvented to FIST 2.0 to orient it towards the goal of Atmanirbhar Bharat so as to create R&D infrastructure not only for experimental work but also to cater to theoretical work, ideas and entrepreneurship. This will create a new paradigm for FIST 2.0,” said Dr. Sanjay Dhande, the new chairperson of FIST Advisory Board.  It will also link up programmes like FIST, Sophisticated Analytical Instrument Facilities (SAIF), and Sophisticated Analytical & Technical Help Institutes (SATHI), all of which are designed to set up S&T infrastructure centres at different levels –department, university, regional and national level respectively. At present, while on an average of about 8,500 researchers use these facilities spread in centres all over India, industries, and startups involved in R&D, technology, and product development have to carry out most high-end experiments and testing of technologies from laboratories outside India. This is because they prefer not to buy equipment and infrastructure which are of limited usage to them, and they cannot access most of the high-end S&T infrastructure set up in the universities and institutions. Till 2019, about 2910 S&T departments and PG colleges have been supported with a total investment of about Rs 2970 crores under FIST. In SAIF, 15 centres have been funded while SATHI has three centres running and more be supported under the R& D infrastructure division. The S&T infrastructure network would now reach out to more beneficiaries and focus on alignment with some of the National Missions and Sustainable Development Goals as well as towards technology translational research promoting different start-ups and industries. The restructuring would also entail a shift from discipline (tool-centric) based research to interdisciplinary problem solution-centric research. This would not only encourage Indian-origin researchers in academic institutes and research organizations across the world and resident counterparts to explore collaborative joint ventures to strengthen the S&T base in India for global development but would also enrol industry in R&D endeavor to bring about direct benefits for the society.  Prof Ashutosh Sharma, Secretary, DST, added, “There is a huge investment in the creation of S&T infrastructure in the country running into several tens of thousands of crores every year in the country, which will bring manifold value with effective and transparent sharing practices with the ease of use. In view of this, DST is also currently formulating a policy on the best practices for the creation, effective use, sharing, maintenance, skill generation, and disposal of the S&T infrastructure.” ]]> https://biospectrumindia.com/news/22/17390/govt-calls-for-investment-in-indian-pharma-sector.html https://biospectrumindia.com/news/22/17390/govt-calls-for-investment-in-indian-pharma-sector.html Thu, 15 Oct 2020 00:00:00 +0530 Union Minister for Chemicals and Fertilizers DV Sadananda Gowda has said India is one of the largest manufacturers and exporters of generic medicines across the world. During  initial phase, he said, HCQ and Azithromycin was identified as one of medicines under treatment protocol for covid-19 in emergency cases. Referring to India supplying these medicines to more than 120 countries across the world, he underlined that india thereby earned the reputation of reliable supplier of medicines.  Gowda informed that India is the only country with largest number of US-FDA compliant Pharma plants (more than 262 including APIs) outside of USA with exports $ 20 billion worth of pharma products to various countries including high standards complying countries like US and Europe.  Addressing  the virtual Latin America & Caribbean session on ‘Reimagining Distances’, during  LEADS 2020, organised by FICCI, Gowda said that  Indian pharma sector can grow to $ 65 billion industry by 2024. "We have recently launched schemes for development of seven mega parks—three bulk drug parks and four medical devices parks across country. New manufacturers will be eligible for Production Linked Incentive (PLI) Scheme under which they will be eligible for financial incentives on basis of their sales for first 5-6 years," Gowda said.  The Minister further emphasised that this is a very- very good time to invest, and set up manufacturing base in India in pharma sector. "One can enter India market through Joint Ventures also. The advantage is that you can get access to big markets like domestic Indian market, US, Japan, EU and South East Asia through India as far as pharma sector is concerned. Any body can contact my office if they are interested in Indian pharma sector, we will provide all possible facilitation and hand holding," he stressed. ]]> https://biospectrumindia.com/news/22/17371/need-for-policymakers-to-revisit-ppo-2-0-from-patients-perspective.html https://biospectrumindia.com/news/22/17371/need-for-policymakers-to-revisit-ppo-2-0-from-patients-perspective.html Mon, 12 Oct 2020 17:55:00 +0530 The Government of India has recently amended its Public Procurement Order (PPO) 2017 in order to promote Make in India and make the country self-reliant. The concept of Class-I, II and non-local suppliers was also introduced, based on which the suppliers would get preference in government purchases of goods and services. This latest revision raises several questions regarding the need of an enabling policy environment which encourages more investment in India and improves India’s rank in the ‘ease of doing business’ index. The changes in PPO 2.0 reflect the need for India to become ‘Aatmanirbhar’ as companies with less than 20 per cent of local content in their goods or services would not able to participate in the government tenders. The move also questions the accessibility of the high-end medical devices which play a key factor in improving patient outcomes. Discussing the role of the new generation lifesaving medical devices, Dr. Gajendra Singh, Public Health Expert, stated, “The government’s decision to modify the public procurement norms to give maximum preference to companies whose goods and services have 50 per cent or more local content to promote ‘self-reliant India’, has highlighted how patients would end up bearing the brunt since they would not be able to access the high risk medical devices in government hospitals. This showcases the need to meet accessibility challenges which are prevalent in the Indian healthcare system. India’s import dependency on other countries for medical devices explains how there is a dire need to fill the infrastructural gaps and build capacity in ensuring quality healthcare for all. We need to think long term and have a vision in place.” Another major setback is the addition of a reciprocity clause in its Public Procurement Order, which states, quaternities of countries which do not allow Indian companies to participate in their government procurement for any item, shall not be allowed to participate in government procurement in India for all items related to that nodal ministry/ department, except for the list of items published by the ministry/ department permitting their participation. The PPO 2.0 needs to be rationalized as per the public demand, by making high-risk medical devices accessible to patients. A clause about the ‘local content’ with no due diligence required on production capacity and financial status of the domestic manufacturers might make the innovative high-end medical technology inaccessible in government hospitals. Expressing his concerns on the impact of PPO 2.0 on patients, Dr. Sanjiv Kumar, Chairperson, Indian Academy of Public Health, Indian Alliance of Patients Groups, stated,  “India needs to strengthen its health infrastructure and tread on the path of medical technology innovations and scale up to save and improve patients’ lives rather than retreating back due to Covid-19 setback. Our policymakers need to revisit the amendments in PPO 2.0 from a patient's perspective. There is a need to improve limited patient access to appropriate medical treatment by using available technology within India and in other countries. The government must increase public expenditure on healthcare and exploit technology.”    ]]> https://biospectrumindia.com/news/22/17361/nathealth-puts-forward-recommendations-to-galvanize-senior-care.html https://biospectrumindia.com/news/22/17361/nathealth-puts-forward-recommendations-to-galvanize-senior-care.html Fri, 09 Oct 2020 00:00:00 +0530 Recognizing the urgent need for immediate action on senior and elderly care in India, Healthcare Federation of India-NATHEALTH has convened a cross-sectorial national forum which brings together all the key stakeholders with relevant experience and expertise in senior care. As part of is immediate initiatives, the forum has assessed and put forth key recommendations to strengthen the Center’s Draft National Policy on Senior Citizens, 2020.  These recommendations are significant considering the changing demographic pattern, socioeconomic needs of the senior citizens, social value system, and advancement in the field of science and technology over the last decade. The new policy will replace the “National Policy on Older Persons, 1999”. The objective of the forum is to drive the right policy structure and governance framework for the Indian Government and establish a coalesced view of the action imperatives for each of the participant and stakeholder segments. It has also initiated work on a joint whitepaper that proposes solutions and ties together a roadmap on priority action areas pertaining to senior care in India. In the engagements so far, the forum has reached an agreement on common priority blocks/solution areas to formulate the agenda for the white paper with the relevant task forces being set up to conduct research and synthesize recommendations. The recommendations for areas that need immediate intervention as suggested by the forum are: Financial security: Critical to support senior citizens via additional tax incentives, higher savings rate, Registered Retirement Saving Plan and pension schemes, similar to those present in other advanced economies. Health care insurance: Major expenses arising from health care needs to be addressed by greater penetration and coverage through health insurances and ironing out issues related to insurance pricing such as the Rashtriya Swasthya Bima Yojana), flexibility, claim management, among others. Shelter for senior citizens: Rental accommodation for senior citizen needs to be encouraged with relevant accreditation, financing, and incentives for private sector to cater to citizens wanting to stay alone Rehab care: Comprehensive policy needed for short term rehab facilities covering all critical aspects such as guidelines, financing, human resources, technology, monitoring, etc. Reskilling and employment: Avenues for active & productive ageing need to be massively increased, especially in the private sector by allowing for such hiring as part of CSR Capacity building: Enhancing human capital to cater to the needs of senior care for medical and non-medical needs is important; establishing “senior care” as a career option via the creation of courses as part of skill training programs, etc. will help address this issue Focus on securing senior women citizens: Special emphasis needed on securing financial and other wellbeing of senior women citizens Investment in technology and promoting innovation and role of start-ups: There is significant scope for investment in technology for the creation of medical devices, dedicated apps, etc. senior citizen use and active startup ecosystem to encourage to help cater to needs of senior citizen and address them through innovative solutions ]]> https://biospectrumindia.com/news/22/17320/ayush-ministry-sets-up-centre-for-medicinal-plants-in-pune.html https://biospectrumindia.com/news/22/17320/ayush-ministry-sets-up-centre-for-medicinal-plants-in-pune.html Fri, 02 Oct 2020 00:00:00 +0530 Vaidya Rajesh Kotecha, Secretary, Ministry of AYUSH has inaugurated the Regional Cum Facilitation Centre, Western Region (RCFC) of the National Medicinal Plants Board (NMPB) under the Ministry of AYUSH at the Savitribai Phule, Pune University, Maharashtra. Speaking on this occasion Kotecha, emphasized the role of RCFCs in completing the objectives of NMPB on medicinal plant cultivation. He explained the efforts of the Ministry of AYUSH in promoting the cultivation of herbs in the upcoming project on Atmanirbhar Bharat. So far, NMPB has established six such Regional Cum Facilitation Centres (RCFCs) since 2017-18 in some premier organizations/universities working on medicinal plants in different regions of the country.  These RCFCs act as an extended arm of NMPB to implement its various schemes with different states level departments like State Medicinal Plants Boards (SMPBs) / State Forests / Agriculture / Horticulture Department etc.  The new RCFC - Western Region will implement and coordinate the activities of NMPB in the States / UTs of Goa, Gujarat, Maharashtra, Rajasthan, Dadra & Nagar Haveli, and Daman & Diu.  This centre facilitates the conservation and cultivation activities along with market up-linking through different AYUSH pharmacies. ]]> https://biospectrumindia.com/news/22/17315/government-to-adopt-security-features-in-ndhm-design.html https://biospectrumindia.com/news/22/17315/government-to-adopt-security-features-in-ndhm-design.html Thu, 01 Oct 2020 00:00:00 +0530 Dr Indu Bhushan, CEO, AB-PMJAY and the National Health Authority (NHA), GoI has said that the National Digital Health Mission (NDHM) blueprint was developed over the last two years, which aims to provide a unique health id to every citizen and link them together with electronic health records. The aim is to improve transparency in the sector, make health services more accessible, interoperable, and make policy more evidence-based.   Addressing a webinar ‘Digital Revolution Going Viral’ during the FICCI HEAL 2020 on 1 October, Dr Bhushan said, “The NDHM has citizens at the center of the whole concept and we are adopting privacy and security in the design itself and not as an afterthought.”   Drawing a parallel with other government initiatives, Dr Bhushan said that India has gone through the FinTech revolution and the Unified Payment Interface (UPI) that has revolutionized the financial sector and we aim to do the same thing in the health sector through the NDHM.   “We will be providing the digital infrastructure and it will revolutionize the health sector,” added Dr Bhushan.   Elaborating on the government’s digital initiatives, specifically on the telemedicine, Dr Bhushan said, “The excitement regarding telemedicine and digitizing the whole healthcare system stems from the PM himself. The NDHM was one of the major announcements from the ramparts of the Red Fort this Independence Day.” He stated that the implementation of the NDHM has been initiated on a pilot basis. “We are acting on the ‘start small, think big and scale fast’ principle, and hopefully, in six months you will start seeing the impact on a larger ecosystem,” noted Dr Bhushan. Highlighting the impact of COVID-19 on digital health, Dr Bhushan said that the crisis has spurred some reforms and digital health is one of them. “The crisis showed the fault lines in the health sector. India is investing too little in health and is one of the lowest in the world. This crisis has shown that we need to do much more and we need to invest more in the primary, secondary, and critical care,” he emphasized.   ]]> https://biospectrumindia.com/news/22/17293/oppi-highlights-need-for-robust-otc-regulation.html https://biospectrumindia.com/news/22/17293/oppi-highlights-need-for-robust-otc-regulation.html Tue, 29 Sep 2020 02:10:00 +0530 The Organisation of Pharmaceutical Producers of India (OPPI), along with industry associations – FICCI and IPA-organised a webinar on the proposed Over-the-counter (OTC) regulations. The webinar highlighted the need for a robust OTC Regulation in the country, in the interest of patients.  Narender K Ahooja, State Drugs Controller (SDC), Food and Drugs Administration (FDA) Haryana who serves as the Chairman Subcommittee on OTC Regulations (also called Ahooja Committee) was invited as a key note speaker. Along withNarender Ahooja, Amit Duggal, Senior Drugs Control Officer, Chandigarh who is also a member of OTC subcommittee, also attended the webinar. Over the years, OPPI has been leading the discussions on the need for a robust OTC guideline, in order to bring responsible health outcomes and improved standards in public health.  The discussions with Ahooja and Duggal covered the following key aspects of the proposed OTC policy:  The OTC drugs will be classified as either OTC -I or OTC -II drugs. OTC-I will be sold through licensed retail pharmacy, but without the prescription of a medical practitioner and OTC – II, which commonly is referred to as GSL drugs, will be permitted to be sold through retailers, such as local grocers. So far as criteria to be OTC drugs are concerned, Shri Ahooja’ s committee has informed that such drugs will have to meet strict safety criteria. Ahooja emphasized that all Manufacturing and Labelling norms under Drugs& Cosmetics Rules, 1945 will be strictly applicable to OTC drugs. On labelling, he mentioned that comprehensive labelling norms will be prescribed for OTC drugs and will have to be complied with, in addition to Rules 96 of Drugs and Cosmetics Rules. Further, advertisement requirements will be relaxed to allow dissemination of information related to the safe and proper use of OTC drugs. However, prohibitions and restrictions imposed under Drugs and Magic Remedies Act related to advertisement of health claims mentioned in the Schedule of the Act are likely to continue.   Commenting on the need for the Policy G Sathya Narayanan, Chairman-OPPI OTC Taskforce and Managing Director, South Asia, Galderma, said, “ Our Study  in 2018 has been much appreciated and welcomed by the regulatory authorities.  Given the healthcare infrastructure in the country,  a robust OTC Policy is the need of the hour.  We are heartened to hear that the Drug Consultative Committee is  looking to forward the recommendations of the OTC Sub-Committee to Drugs Technical Advisory Board (DTAB) , at the earliest, for a  well-defined OTC Regulation in the country.  The Regulation will empower patients to responsibly self-medicate and thereby ease the burden on the healthcare system.  It  will go a long way in delivering ‘health for all’, in the country and widen access to medicines in India.” Echoing the need for such a regulation, Milind Thatte, Co-Chairman - OPPI OTC Taskforce and Managing Director, Procter & Gamble Health said, “ Keeping the patient at the centre, the proposed OTC Regulation will provide a framework for patients to be aware about the right product for the right ailment at the right time and the right way to use, thereby enhancing health outcomes and minimizing risk from misuse or abuse of medicines.” ]]> https://biospectrumindia.com/news/22/17283/health-ministry-unveils-covid-19-vaccine-and-clinical-registry-portal.html https://biospectrumindia.com/news/22/17283/health-ministry-unveils-covid-19-vaccine-and-clinical-registry-portal.html Mon, 28 Sep 2020 09:45:00 +0530 Dr. Harsh Vardhan, Union Minister for Health & Family Welfare, Government of India launched the vaccine portal for COVID-19 and National Clinical Registry for COVID-19 developed by ICMR. Releasing these 2 web portals, Dr Harsh Vardhan said "ICMR has always been in the forefront of health research in the country and is now leading the country in tackling the unprecedented pandemic through scientific rigour and innovation. To disseminate the vaccine related information the exclusive portal will be helpful in creating awareness among the masses. I hope all queries of common people on the vaccine development process will be addressed through this portal and I am confident it will become the most visited portal in times to come.” The National Clinical Registry for COVID-19 will collect systematic data on clinical signs & symptoms, laboratory investigations, management protocols, clinical course of COVID-19 disease, disease spectrum and outcomes of patients. The data will serve as an invaluable tool for formulating appropriate patient management strategies, predicting disease severity, patient outcomes etc. Dr Harsh Vardhan, added that, “The portal on National Clinical Registry for COVID-19 developed by ICMR will be immensely useful. The registry will aim at collecting good quality real time clinical data to inform evidence-based clinical practice, research, formulating guidelines and policy making.” The vaccine portal consists of all the information regarding the Indian efforts towards vaccine development against various diseases including the most recent COVID-19. Interested people can visit the website on https://vaccine.icmr.org.in to get the latest information on vaccine development. ]]> https://biospectrumindia.com/news/22/17277/government-constitutes-national-medical-commission.html https://biospectrumindia.com/news/22/17277/government-constitutes-national-medical-commission.html Fri, 25 Sep 2020 01:05:00 +0530 Historic reform in the field of medical education has been effected by the Union Government with the constitution of the National Medical Commission (NMC), along with four Autonomous Boards. With this, the decades old institution of the Medical Council of India (MCI) stands abolished. Along with NMC, the four Autonomous Boards of UG and PG Medical Education Boards, Medical Assessment and Rating Board, and Ethics and Medical Registration Board have also been constituted to help the NMC in day to day functioning. This will steer medical education towards a transparent, qualitative and accountable system. The basic change that has happened is that the Regulator is now 'selected' on merits, as opposed to an 'elected' Regulator. Men and Women with impeccable integrity, professionalism, experience and stature have been now placed at the helm to steer the medical education reforms further. Dr S C Sharma (retd. Prof, ENT, AIIMS, Delhi) has been selected as the Chairperson for a period of three years. Besides the Chairperson, NMC will have 10 ex-officio members that include Presidents of the four Autonomous Boards, Dr.Jagat Ram, Director PGIMER, Chandigarh, Dr RajendraABadwe, Tata Memorial Hospital, Mumbai and Dr SurekhaKishore, Executive Director, AIIMS, Gorakhpur. In addition, NMC will have 10 nominees from Vice Chancellors of Health Universities from States/UTs, 9 nominees from State Medical Councils, and three expert members from diverse professions. Dr SmitaKolhe, a renowned social worker working in tribal Melaghat area of Maharashtra and Santosh Kumar Kraleti, CEO, Foot Soldiers for Health Pvt Ltd have been nominated as these expert members. Dr R K Vats will head the Secretariat as Secretary of the NMC. The NMC will carry forward the reforms initiated by the Board of Governors under Dr V K Paul. Already, number of MBBS seats has increased over the last six years by 48% from around 54000 in 2014 to 80,000 in 2020. The PG seats have increased by 79% from 24000 to 54000 in the same duration. The key functions of the NMC will be further streamlining regulations, rating of institutions, HR assessment, focus on research. Besides they will work on modalities of the common final year exam after MBBS (NEXT- National Exit Test) to serve for both registration and PG entrance; prepare guidelines for fee regulation by private medical colleges; and developing standards for Community Health Providers to serve in primary healthcare with limited practicing licence. It may be recalled that the National Medical Commission Act, 2019 was passed by the Parliament in August, 2019. ]]> https://biospectrumindia.com/news/22/17258/government-issues-regulatory-guidelines-for-covid-19-vaccine.html https://biospectrumindia.com/news/22/17258/government-issues-regulatory-guidelines-for-covid-19-vaccine.html Wed, 23 Sep 2020 00:00:00 +0530 Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India has launched draft regulatory guidelines for development of vaccines with special consideration for COVID-19 vaccine. This document will provide guidance to the vaccine developers to ensure that- Vaccines are well-characterized and manufactured consistently. Vaccines remain stable at the recommended storage conditions for the duration of clinical trial during clinical development stage and throughout its shelf life post approval. Adequate toxicity data as well as immunogenicity in respect of humoral and/or cellmediated immune response are generated in nonclinical studies in relevant animal models. Challenge studies in relevant animal species and non-human primates may be conducted concurrently with clinical trial. Adequate clinical data to establish safety and protective immunity are generated. Post Marketing Surveillance including assessment of Adverse Events Following Immunization (AEFI) and Adverse Events of Special Interest (AESI) is carried out to assess vaccine safety in post market scenario.   The document also states that for a COVID-19 vaccine candidate consisting of a novel product type and for which no prior nonclinical and clinical data are available, nonclinical safety studies will be required prior to proceeding to first in human (FIH) clinical trials.  ]]> https://biospectrumindia.com/news/22/17235/dcgi-approves-indias-first-crispr-covid-19-test.html https://biospectrumindia.com/news/22/17235/dcgi-approves-indias-first-crispr-covid-19-test.html Mon, 21 Sep 2020 00:00:00 +0530 The Tata CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) test, powered by CSIR-IGIB (Institute of Genomics and Integrative Biology) FELUDA, has received regulatory approvals from the Drug Controller General of India (DCGI) for commercial launch, as per ICMR guidelines, meeting high quality benchmarks with 96% sensitivity and 98% specificity for detecting the novel coronavirus. This test uses an indigenously developed, cutting-edge CRISPR technology for detection of the genomic sequence of SARS-CoV-2 virus. CRISPR is a genome editing technology to diagnosing diseases. The Tata CRISPR test is the world’s first diagnostic test to deploy a specially adapted Cas9 protein to successfully detect the virus causing Covid-19. This marks a significant achievement for the Indian scientific community, moving from R&D to a high-accuracy, scalable and reliable test in less than 100 days. The Tata CRISPR test achieves accuracy levels oftraditional RT-PCR tests, with quicker turnaround time, less expensive equipment, and better ease of use. Moreover, CRISPR is a futuristic technology that can also be configured for detection of multiple other pathogens in the future. The effort is the result of a fruitful collaboration between the scientific community and industry. The Tata Group has worked closely with CSIR-IGIB and ICMR to create a high-quality test that will help the nation ramp up Covid-19 testing quickly and economically, with a ‘Made in India’ product that is safe, reliable, affordable, and accessible.  ]]> https://biospectrumindia.com/news/22/17229/nppa-extends-ceiling-prices-of-knee-implants.html https://biospectrumindia.com/news/22/17229/nppa-extends-ceiling-prices-of-knee-implants.html Fri, 18 Sep 2020 00:00:00 +0530 To ensure  accessibility of necessary medical devices to the common man at genuine cost, drug price regulator,  National Pharmaceutical Pricing Authority (NPPA) under the Department  of Pharmaceuticals , Ministry of Chemicals & Fertilizers  has extended ceiling prices of Knee Implants for another one year, i.e. till 14th September 2021. A notification has been issued by NPPA under Drug Price Control Order (DPCO) ,2013 (Annex-II)in this regard.  NPPA vide Order No. S.O. 2668(E), dated 16th August, 2017 for the first time fixed the ceiling price of orthopaedic knee implants for a period of one year . This was  extended for further one year in 13th August 2018 and then on 15th August 2019. The above period ended on 15th August 2020 and the ceiling prices for knee implants for knee replacement system was due for review by 15-Aug-2020.  NPPA in July 2020 directed all companies manufacturing and importing primary and revision knee system to submit sales data for the period July 2018 to June 2020. In its meetings held on 6th August  2020 , NPPA  after observing  the data collected from 14 major companies (10  importers and 4 domestic manufacturers) decided that the ceiling prices for knee implants as applicable on 15th August 2020 may be further extended up to one month up to 15th September 2020.   The matter was discussed again in the Authority Meeting held on 14th September 2020. In the meeting it was noted that fixing Ceiling Prices for Orthopaedic Knee Implants in the year 2017 had resulted in price reduction up to 69% and domestic manufacturers market share has risen by 11% over the period of two years, which is in line with the Government’s motto of ‘Atmanirbhar Bharat’.   Keeping this in view it was felt necessary that ceiling price system continue to be regulated in wider public interest. Accordingly the Authority decided to extend the  existing ceiling prices for another one year (up to 14th September 2021) and notification dated 15th September 2020 was  issued in this regard.The move has enable to save 1500 crore Rupees of the common man. ]]> https://biospectrumindia.com/news/22/17206/mohfw-issues-protocol-on-post-covid-management-.html https://biospectrumindia.com/news/22/17206/mohfw-issues-protocol-on-post-covid-management-.html Tue, 15 Sep 2020 10:20:00 +0530 Ministry of Health and Family Welfare (MoHFW) has issued a protocol on post COVID management recently. The protocol provides an integrated holistic approach for patients of COVID to care at home and is not meant to be used as preventive/curative therapy. It also states that the recovery period is likely to be longer for patients who suffered from a more severe form of the disease and those with pre-existing illnesses. The protocol is also notable for the induction of various AYUSH practices of healthcare to facilitate faster recuperation of health of recovered COVID 19 patients. The Post- COVID follow up protocol, on an individual level, advises continued appropriate use of mask, hand and respiratory hygiene, physical distancing etc. Adequate consumption of hot water and immunity promoting AYUSH medicine is advised after prescribed by a qualified practitioner of AYUSH. Mild/moderate exercises like Yogasana, Pranayama, Meditation is to be practiced daily as prescribed while daily morning or evening walk at a comfortable pace as tolerated. The protocol advises consuming a balanced nutritious diet that is easy to digest and is freshly prepared. On the community level, a person can take the support of community-based self-help groups, qualified professionals, etc for the recovery and rehabilitation process.  The doctor also mentions visiting the nearest health facility if the patient who had undergone home isolation complains of persisting symptoms. At the individual level, immunity promoting AYUSH medicine as per the advisories already released by the AYUSH Ministry is recommended. These include Ayush Kwath, the Samshamanivati, Giloy powder with lukewarm water, Ashwagandha and Chyawanprash. Other recommendations include Amla fruit, Mulethi powder and Haldi milk. ]]> https://biospectrumindia.com/news/22/17136/abbott-receives-dcgi-approval-for-cardiac-drug-ivabradine.html https://biospectrumindia.com/news/22/17136/abbott-receives-dcgi-approval-for-cardiac-drug-ivabradine.html Wed, 02 Sep 2020 16:55:00 +0530 The global healthcare company Abbott has recently announced that it has received approval from the Drugs Controller General of India (DCGI) for its Ivabradine, once-a-day formulation. Abbott has developed India’s first once-daily prolonged-release (PR) version of Ivabradine indicated for patients with chronic heart failure and chronic stable angina to address the unmet need for chronic cardiac diseases in India. Abbott plans to launch the Ivabradine PR tablets in the Indian market in the coming weeks. In India, the estimate of people with heart failure range between 1.3 and 4.6 million, with 0.5–1.8 million new cases recorded every year. According to the Global Burden of Disease study, an estimated 14.4 million men and 7.7 million women have lost their productive years to coronary heart disease-related disability. An AIIMS study estimates that non-adherence to medication ranges from 24% for people with cardiac disease to 50%-80% for people with hypertension in India. Ivabradine PR tablets can be prescribed as a once-a-day medicine compared to the multiple dosing generally required by patients for the management of the disease. A phase 3 clinical study conducted by Abbott across 21 centers in India, the first of its kind to be conducted for this formulation, showed Ivabradine PR once-a-day formulation to be comparable with the conventional Ivabradine twice-a-day, in the management of patients with stable chronic heart failure, with comparable efficacy and safety profile.  Ivabradine helps maintain a stable heart rate and prevent it from spiking, which is an important prerequisite in reducing symptoms and in improving the prognosis of both conditions. ]]> https://biospectrumindia.com/news/22/17126/japan-commits-rs-3500cr-to-strengthen-indian-health-sector.html https://biospectrumindia.com/news/22/17126/japan-commits-rs-3500cr-to-strengthen-indian-health-sector.html Tue, 01 Sep 2020 00:00:00 +0530 The Govt. of Japan has committed Official Development Assistance loan of an amount of JPY50 billion (approx. Rs. 3,500 crore) for the COVID-19 Crisis Emergency Response Support. The Notes were exchanged between Dr. C.S. Mohapatra, Additional Secretary, Department of Economic Affairs, Government of India, and Suzuki Satoshi, Ambassador, Embassy of Japan to India for a health sector programme loan to fight the COVID-19 crisis. Subsequent to the Exchange of Notes, Loan Agreement for this programme loan was signed between Dr. C.S. Mohapatra, Additional Secretary, Department of Economic Affairs, Ministry of Finance, Government of India and Katsuo Matsumoto, Chief Representative, JICA, New Delhi. This programme loan aims to support India’s efforts in fighting COVID-19 and to prepare the health system to manage future epidemics and also to improve the resilience of India’s health systems against infectious diseases. In addition, notes were also exchanged between Dr. C.S. Mohapatra, Additional Secretary, Department of Economic Affairs, and Suzuki Satoshi, Ambassador, Embassy of Japan to India for Grant Assistance of an amount of JPY 1 billion (= approx. Rs. 70 crore) from Government of Japan. This Grant-in-aid from Government of Japan is for providing medical equipment to strengthen the public health and medical system in India. This will strengthen the health care facilities for managing critical and serious patients suffering from COVID-19 infection. India and Japan have had a long and fruitful history of bilateral development cooperation since 1958. In the last few years, the economic cooperation between India and Japan has strengthened and grown into strategic partnership. This further consolidates and strengthens the Strategic and Global Partnership between India and Japan. ]]> https://biospectrumindia.com/news/22/17075/dcgi-approves-cell-therapy-for-treating-critical-limb-ischemia.html https://biospectrumindia.com/news/22/17075/dcgi-approves-cell-therapy-for-treating-critical-limb-ischemia.html Fri, 21 Aug 2020 00:00:00 +0530 Mumbai based Cipla has announced that its partner Stempeutics Research Pvt. Ltd has received regulatory approval by the Drug Controller General of India (DCGI) for the launch of Stempeucel® in India. The product is indicated for the treatment of CLI due to Buerger's Disease and Atherosclerotic Peripheral Arterial Disease. It is the first allogeneic cell therapy product to be approved for commercial use in India and the first stem cell product to be approved globally for CLI treatment.  CLI is a progressive form of peripheral arterial disease that is caused by severe blockage in the arteries thereby reducing blood flow. This may result in the development of sores and wounds in legs and feet with a high risk of limb amputation. It is estimated that about 5 million patients in India are impacted by this debilitating disease.  The product has been developed by Stempeutics over a period of twelve years. The company's proprietary pooling approach provides for an efficient manufacturing process thereby enabling the product to be made accessible to patients at an affordable cost. More than one million doses can be produced from a single set of master cell banks, which is unique in regenerative medicine, thus providing consistent product to patients. The proprietary technology also helps Stempeucel® extend the therapeutic potential of the drug across multiple disease categories. Under the agreement signed between the two companies, Cipla has received exclusive rights to market and distribute the product in India by leveraging its expansive distribution strengths across the country. ]]> https://biospectrumindia.com/news/22/17038/nppa-sets-up-pricing-unit-in-karnataka.html https://biospectrumindia.com/news/22/17038/nppa-sets-up-pricing-unit-in-karnataka.html Fri, 14 Aug 2020 00:00:00 +0530 A Price Monitoring and Resource Unit (PMRU) has been set up in Karnataka under the aegis of National Pharmaceutical Pricing Authority (NPPA), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India.    PMRU will function at the State level under the direct supervision of the State Drug Controller for increasing outreach of NPPA. PMRUs are societies registered under the Societies Registration Act having its own Memorandum of Association/ Bye laws. The Board of Governors of PMRU includes the representatives from Central Government and State Government concerned and other stakeholders. NPPA, under its Central Sector Scheme named Consumer Awareness, Publicity and Price Monitoring (CAPPM), has  already   set up of PMRUs in 12 States/ UTs, including Kerala, Odisha, Gujarat, Rajasthan, Haryana, Nagaland, Tripura, Uttar Pradesh, Punjab, Andhra Pradesh, Mizoram and Jammu & Kashmir. NPPA has plans to set up PMRUs in all the 36 States/ UTs. The expenses of PMRUs, both recurring and non-recurring are borne by NPPA under the Scheme. Till now NPPA is headquartered at Delhi only and with the setting up of PMRUs in States/ UTs, NPPA shall have outreach at State Level as well.  The primary function of PMRUs is to assist NPPA in monitoring of prices of drugs, ensuring availability of drugs and raising consumer awareness. They act as collaborating partners of NPPA with information gathering mechanism at the grass-roots level. They will render necessary technical assistance to both the NPPA and the respective State Drug Controllers of States/ Union Territories.   ]]> https://biospectrumindia.com/news/22/17026/govt-delves-on-procurement-mechanisms-for-covid-19-vaccine.html https://biospectrumindia.com/news/22/17026/govt-delves-on-procurement-mechanisms-for-covid-19-vaccine.html Wed, 12 Aug 2020 17:00:00 +0530 National Expert Group on Vaccine Administration for COVID-19, met for the first time on 12th August. The meeting was chaired by Dr V K Paul, Member Niti Aayog along with Secretary (Ministry of Health and Family Welfare) as co-Chair. The expert group deliberated on conceptualization and implementation mechanisms for creation of a digital infrastructure for inventory management and delivery mechanism of the vaccine including tracking of vaccination process with particular focus on last mile delivery. They discussed on broad parameters guiding the selection of COVID-19 vaccine candidates for the country and sought inputs from Standing Technical Sub-Committee of National Technical Advisory Group on Immunization (NTAGI). The group delved on the procurement mechanisms for COVID-19 vaccine, including both indigenous and international manufacturing along with guiding principles for prioritization of population groups for vaccination. The expert group discussed on the financial resources required for procurement of COVID-19 vaccine and various options of financing the same. Available options in terms of delivery platforms, cold chain and associated infrastructure for roll out of COVID-19 vaccination were also taken up. Further, strategy and follow-up action on all possible scenarios to ensure equitable and transparent delivery of vaccine was deliberated upon. Issues related to vaccine safety and surveillance were taken up and strategy for community involvement through transparent information and awareness creation were discussed. India’s support to its key neighbors and development partner countries for COVID-19 vaccines was deliberated upon. The expert group discussed that India will leverage domestic vaccine manufacturing capacity and will also engage with all international players for early delivery of vaccines not only in India but also in low and middle income countries. The Committee also advised all the States not to chart separate pathways of procurement. ]]> https://biospectrumindia.com/news/22/16985/health-ministry-employs-e-vaccine-intelligence-network.html https://biospectrumindia.com/news/22/16985/health-ministry-employs-e-vaccine-intelligence-network.html Thu, 06 Aug 2020 00:00:00 +0530 The Electronic Vaccine Intelligence Network (eVIN) is an innovative technological solution aimed at strengthening immunization supply chain systems across the country. This is being implemented under National Health Mission (NHM) by Ministry of Health and Family Welfare. eVIN aims to provide real-time information on vaccine stocks and flows, and storage temperatures across all cold chain points in the country. This robust system has been used with the requisite customization during the COVID pandemic for ensuring continuation of the essential immunization services and protecting our children and pregnant mothers against vaccine preventable diseases. eVIN combines state-of-the-art technology, a strong IT infrastructure and trained human resource to enable real time monitoring of stock and storage temperature of the vaccines kept in multiple locations across the country. eVIN has reached 32 States and Union Territories (UTs) and will soon be rolled-out in the remaining States and UTs of Andaman & Nicobar Islands, Chandigarh, Ladakh and Sikkim. At present, 23,507 cold chain points across 585 districts of 22 States and 2 UTs routinely use the eVIN technology for efficient vaccine logistics management. Over 41,420 vaccine cold chain handlers have been introduced to digital record-keeping by training them on eVIN. Nearly 23,900 electronic temperature loggers have been installed on vaccine cold chain equipment for accurate temperature review of vaccines in storage. ]]> https://biospectrumindia.com/news/22/16959/govt-launches-five-dedicated-covid-19-biorepositories.html https://biospectrumindia.com/news/22/16959/govt-launches-five-dedicated-covid-19-biorepositories.html Mon, 03 Aug 2020 10:50:00 +0530 Dr. Harsh Vardhan, Minister for Science & Technology, Health & Family Welfare and Earth Sciences, Government of India, has launched and dedicated to the nation the largest network of five dedicated COVID-19 Biorepositories established by Department of Biotechnology in record time. These are at Translational Health Science and Technology Institute (THSTI) Faridabad, Institute of Life Science (ILS) Bhubaneshwar, Institute of Liver and Biliary Sciences (ILBS) New Delhi, National Centre for Cell Science (NCCS) Pune and Institute for Stem Cell Science and Regenerative Medicine (InStem) Bangalore. He complemented the efforts of DBT in “the relentless war for mitigation of this Pandemic”. ]]> https://biospectrumindia.com/news/22/16957/experts-call-for-more-innovation-to-control-covid-19.html https://biospectrumindia.com/news/22/16957/experts-call-for-more-innovation-to-control-covid-19.html Mon, 03 Aug 2020 08:00:00 +0530 The Indian Council of Medical Research (ICMR) convened a multicountry online symposium on novel approaches in science and ethics of vaccine development, bringing leading vaccine scientists and researchers to a common platform. The symposium called on countries and scientific institutions to rapidly advance vaccine trials without cutting corners. In addition, experts agreed that all vaccine trials must and can conform to the highest standards of patient safety and ethical norms while exploring fast tracking methods. Participants also commended the efforts of India in its contributions to vaccine development and preparedness. Prof. K. VijayRaghavan, Principal Scientific Adviser to the Government of India, while opening the symposium said “we cannot afford to let COVID-19 dictate our lives, the scientific community must come together to find a timely solution to this pandemic”. He highlighted, vaccine development under pandemic conditions is much more challenging than in ordinary times. Ensuring the development of a safe and effective vaccine, in a timely manner, involves understanding the merits of different approaches to development techniques, varied validation approaches, and the ethical considerations around all of them. Above all, the principles of community engagement and informed consent is to be upheld in all vaccine development and rollout efforts. “India has to be at the forefront of global vaccine preparedness,” said Professor Balram Bhargava, Director-General of ICMR. “We are committed to work with the global scientific community in ensuring that a vaccine is available in a timely manner. ]]> https://biospectrumindia.com/news/22/16941/cabinet-approves-mou-between-india-and-zimbabwe-for-traditional-medicines.html https://biospectrumindia.com/news/22/16941/cabinet-approves-mou-between-india-and-zimbabwe-for-traditional-medicines.html Thu, 30 Jul 2020 10:35:00 +0530 The Union Cabinet chaired by the Prime Minister, Narendra Modi has given ex-post facto approval to Memorandum of Understanding (MoU) signed between the Republic of India and the Republic of Zimbabwe on Cooperation in the field of Traditional Systems of Medicine and Homeopathy.  The MoU was signed on November 3rd, 2018. This will provide a frame work for the cooperation between the two countries for the promotion of traditional systems of medicine and homeopathy and will mutually benefit the two countries in the field of Traditional Medicine.  The main objective of the MoU is to strengthen, promote and develop co-operation in the field of traditional systems of medicine between the two countries on the basis of equality and mutual benefit. The MoU identifies following areas of cooperation: Promotion in the regulation of teaching, practice, drugs, and drugless therapies within the scope of the MoU Supply of all medicine materials and documents necessary for demonstration and reference in achieving the objectives specified within the framework of the MoU; Exchange of experts for the training of practitioners, paramedics, scientists, teaching professionals and students; Accommodation of interested scientists, practitioners, paramedics and students in Institutions for Research, Educational and Training Programmes; Mutual recognition of Pharmacopoeias and Formularies; Mutual recognition of systems of medicines which are officially recognized by the Parties; Mutual recognition of Educational Qualifications awarded Central/State recognized Universities of the Parties; Provision of Scholarships for education in recognized Institutions; Recognition of traditional preparations on a reciprocal basis by the qualified practitioners as per the existing laws of the respective Countries; Permission to practice on reciprocal basis by the qualified practitioners as per the existing laws of the respective Countries; Any other areas and/or forms of cooperation mutually agreed upon subsequently by the Parties. ]]> https://biospectrumindia.com/news/22/16921/govt-announces-guidelines-for-bulk-drugs-parks-medical-devices-parks-.html https://biospectrumindia.com/news/22/16921/govt-announces-guidelines-for-bulk-drugs-parks-medical-devices-parks-.html Mon, 27 Jul 2020 18:00:00 +0530 Union Minister for Chemicals and Fertilizers DV Sadananda Gowda has launched four schemes of Department of Pharmaceuticals for promotion of domestic manufacturing of bulk drugs and medical devices parks in the country, two each for Bulk Drugs and Medical Devices parks. The guidelines are available on the website of the Department of Pharmaceuticals. The list of 41 products contained in the scheme guidelines will enable domestic production of 53 bulk drugs. Financial incentives will be given to a maximum of 136 manufacturers selected under the scheme as a fixed percentage of their domestic sales of these 41 products manufactured locally with required level of domestic value addition.  The incentives would be subject to annual ceilings communicated in the approval letter. The incentives would be given for a period of 6 years. In case of fermentation based products, the rate of incentive is 20% for first four years, 15% for the fifth year and 5% for the sixth year. In case of chemically synthesised products, rate of incentive is 10% for all six years. “We welcome the announcement of 4 new Medical Device Parks and Production Linked incentives (PLI) schemes. These schemes are targeted to promote manufacturing of medical devices in India which are competitive in quality as well as cost and help contribute to achieve Atmanirbharta in MedTech. These are also aimed at attracting global innovators as well as large domestic companies from allied industries to invest in MedTech.” – Pavan Choudary, Chairman and Director General, Medical Technology Association of India (MTaI) ]]> https://biospectrumindia.com/news/22/16912/dst-launches-rs-15-cr-fund-to-support-joint-rd-with-russia.html https://biospectrumindia.com/news/22/16912/dst-launches-rs-15-cr-fund-to-support-joint-rd-with-russia.html Fri, 24 Jul 2020 18:00:00 +0530 The Department of Science and Technology (DST) has launched the India-Russia Joint Technology Assessment and Accelerated Commercialization Programme in partnership with the Federation of Indian Chambers of Commerce and Industry (FICCI) and Foundation for Assistance to Small Innovative Enterprises (FASIE) of the Russian Federation. The programme will connect Indian, and Russian Science & Technology (S&T) led SMEs and Start-ups for joint R&D for technology development and for cross-country technology adaptation. The programme will run through two annual cycles with up to five projects to be funded under each cycle. Projects are being sought on leading S&T focus areas, including but not limited to, IT & ICT (including AI, AR, VR), Medicine & Pharmaceuticals, Renewable Energy, Aerospace, Alternative Technologies, Environment, New Materials, Biotechnologies, Robotics and Drones. On behalf of DST, FICCI will implement the programme in India. Over a period of two years, the Department of Science and Technology will fund up to Rs 15 Crores to ten Indian SMEs/Start-ups and FASIE will provide similar funding to the Russian projects.  The programme will provide access to partial public funding for jointly selected projects with the participation of at least one start-up/SME from India and one SME from Russia. The selected projects will be required to bear partial funding as well, either through own funds or alternate sources of funding. In addition to the financial support, the teams will also be supported through capacity building, mentorship and business development.   ]]> https://biospectrumindia.com/news/22/16869/tifac-releases-report-on-indigenous-production-of-api-.html https://biospectrumindia.com/news/22/16869/tifac-releases-report-on-indigenous-production-of-api-.html Mon, 20 Jul 2020 06:50:00 +0530 Indigenous production of Active Pharmaceutical Ingredients (APIs) needs to be scaled up to a level where the production is economically viable, says a report which identified a list of APIs that need prioritized manufacturing and the associated advantages. The report titled ‘Active Pharmaceutical Ingredients- Status, Issues, Technology Readiness, and Challenges’ was brought out recently by Technology Information Forecasting and Assessment Council (TIFAC), an autonomous organization under the Department of Science & Technology, Government of India. It was released along with a white paper on ‘Focused Interventions for ‘Make in India’: Post COVID 19’ by Dr. Harsh Vardhan, Union Minister for Science & Technology, Health and Family Welfare and Earth Sciences at a virtual function recently. The major recommendations given in the report include focus on engineering and scale aspect of technology development, need for mission mode Chemical Engineering with defined targets for uninterrupted synthesis of molecules and to create mega drug manufacturing clusters with common infrastructure in India and the technology platform to be developed for biocatalysis towards reducing process steps for cost optimization and for fluorination, Investment on priority in fermentation sector of large capacity and scale supporting techno-economic feasibility, attention to technologies like hazardous reactions, flow chemistry, cryogenic reactions, and membrane technology. The report further suggests chiral building blocks through biocatalysis for production of niche intermediates involving enzymatic reactions or fermentation as an area of potential exploitation for Indian API industry and focus on antiviral drugs, which require nucleic acid building blocks - Thymidine/ Cytosine Adenine/ Guanine none of which are manufactured in India because of lack of cyanation plants.  The report recommends for government encouragement of Indian companies working in chemical segments such as steroids, amino acids, carbohydrates, nucleosides, etc., to collaborate for technology development or quick technology transfer as well as the need for closer academia-industry interaction for technology development and commercialization. ]]> https://biospectrumindia.com/news/22/16856/dcgi-approves-first-indigenous-pneumonia-vaccine.html https://biospectrumindia.com/news/22/16856/dcgi-approves-first-indigenous-pneumonia-vaccine.html Wed, 15 Jul 2020 21:00:00 +0530 Drug Controller General of India (DCGI) has given approval to the first fully indigenously developed Pneumococcal Polysaccharide Conjugate Vaccine. This vaccine has been developed by Serum Institute of India Pvt. Ltd (SIIPL), Pune. Serum Institute first obtained the approval of DCGI to conduct Phase I, Phase II and Phase III clinical trials of Pneumococcal Polysaccharide Conjugate Vaccine in India. These trials have since been concluded within the country. SIIPL has also conducted these clinical trials in another country i.e. Gambia.  Thereafter, SIIPL applied for approval and permission to manufacture this vaccine. The application along with the clinical trial data has been reviewed by the Office of Drug Controller General of India with the help of Special Expert Committee (SEC) for vaccines.  The Committee recommended for grant of permission of market authorization to the said vaccine. On 14/07/2020, SIIPL has been granted permission to manufacture domestically developed first Pneumococcal Polysaccharide Conjugate Vaccine. This is the first indigenously developed vaccine in the field of pneumonia. Earlier the demand of such vaccine was substantially met by licensed importers in the country since the manufacturers were all vaccine companies based outside India. This vaccine is used for active immunization against invasive disease and pneumonia caused by “Streptococcus pneumonia” in infants.  The vaccine is administered in a intramuscular manner. ]]> https://biospectrumindia.com/news/22/16834/govt-fixing-guidelines-for-bulk-drug-parks-medical-devices-parks.html https://biospectrumindia.com/news/22/16834/govt-fixing-guidelines-for-bulk-drug-parks-medical-devices-parks.html Tue, 14 Jul 2020 08:25:00 +0530 Union Minister of Chemicals & Fertilisers DV Sadananda Gowda has said that Department of Pharmaceuticals is finalizing guidelines which will form basis for objectively selecting locations of upcoming three bulk drugs parks and four medical devices parks  in the country. Finance Minister of Punjab Manpreet Singh Badal met Gowda  in New Delhi  and handed over request letter to, for considering setting up of one of the proposed Bulk Drug Park in Bhatinda in the State of Punjab. Badal said that the location at Bhatinda has good connectivity, water and land availability, and the State already has presence of some of biggest USFDA approved pharmaceutical companies and pharma institutes like NIPER, IISER, AIIMS among others.  The scheme for promotion of bulk drug park is expected to result in incremental production of bulk drugs worth about Rs 46,400 crore, while scheme for promotion of medical device park will lead to incremental production of medical devices worth about Rs 68,437 crore. These schemes will also result in significant generation of jobs ]]> https://biospectrumindia.com/news/22/16830/health-ministry-points-out-5-critical-sectors-for-economic-growth.html https://biospectrumindia.com/news/22/16830/health-ministry-points-out-5-critical-sectors-for-economic-growth.html Mon, 13 Jul 2020 05:05:00 +0530 Dr. Harsh Vardhan, Union Minister for Science & Technology, Health and Family Welfare and Earth Sciences has released a white paper on “Focused Interventions for ‘Make in India’: Post COVID 19” and “Active Pharmaceutical Ingredients: Status, Issues, Technology Readiness and Challenges”, prepared by Technology Information, Forecasting and Assessment Council (TIFAC). Dr. V K Saraswat, Chairman TIFAC Governing Council, and Prof. Pradeep Srivastava, Executive Director, TIFAC, Dr. Sanjay Singh, Scientist ‘G’ and Mukesh Mathur, Incharge (F&A), TIFAC were also present on the occasion. This White Paper captures sector-specific strengths, market trends, and opportunities in five sectors, critical from the country’s perspective, includes healthcare, machinery, ICT, agriculture, manufacturing, and electronics with reference to supply and demand, self-sufficiency and mass-scale production capacity. It has identified policy options primarily in the areas of Public health system, MSME sector, Global relations: FDI, recalibrated trade alignments, new-age technologies, etc. This is precisely important for the development of technology clusters in champion segments, creating Technology Start-up Exchange, identifying, supporting, and piloting ten blockbuster technologies and collaborating with new dynamics with incubators of Israel, Germany, towards promoting import substitution as well as evolving technology platforms in sunrise technologies.  The recommendations are directed towards giving immediate technology and policy impetus to make India “ATMANIRBHAR”. Based on the linkages and interdependencies between the outputs of different sectors, output multiplier and income multiplier for various sectors have been presented in the paper. Pointing out that “India has been largely successful in mitigating the impacts of COVID-19 so far”, Dr. Harsh Vardhan said, “We got the opportunity to position ourselves as a Global manufacturing hub with a big push under ‘Make In India’ with adoption of appropriate technology and policy reforms and focused thrust in crucial sectors”. He emphasized that “This calls for furthering investment in developing infrastructure, industrialization, strengthening supply chain mechanism, creating demand for goods and services, converting farming into a business proposition etc.” The Minister said, “The current pandemic is global, but the solutions to the challenge should be local.” ]]> https://biospectrumindia.com/news/22/16803/meity-niti-aayog-launches-digital-india-app-innovation-challenge.html https://biospectrumindia.com/news/22/16803/meity-niti-aayog-launches-digital-india-app-innovation-challenge.html Wed, 08 Jul 2020 06:30:00 +0530 With an objective to support and build a strong ecosystem for Indian Apps, the Ministry of Electronics and Information Technology (MeitY) in partnership with Atal Innovation Mission – Niti Aayog launches Digital India AatmaNirbhar Bharat App Innovation Challenge for Indian tech entrepreneurs and Startups. This is to help realise the vision of Prime Minister for building a Digital India and using Digital Technologies for building an AatmaNirbhar Bharat. This shall run in 2 tracks: Promotion of Existing Apps and Development of New Apps. The focus of the Track 1 App Innovation Challenge, being launched today is to identify the best Indian Apps that are already being used by citizens and have the potential to scale and become world class Apps in their respective categories. This Innovation Challenge with various cash awards and incentives of featuring Apps on Leader Boards seeks to create an ecosystem where Indian entrepreneurs and Startups are incentivised to ideate, incubate, build, nurture and sustain Tech solutions that can serve not only citizens within India but also the world. The Mantra is to Make in India for India and the World. This shall be completed in a month. Subsequent to this App Innovation Challenge, Government will also launch Track 2 of the AatmaNirbhar Bharat App Innovation Challenge that will seek to identify Indian start ups / entrepreneurs /companies and encourage them with ideation,  incubation, prototyping and roll out of applications. This track will run for a longer course of a time, details of which shall be provided separately. The AatmaNirbhar Bharat App Innovation Challenge Track 1 is being launched in a number of categories including health, wellness. There may be several sub categories within each category. ]]> https://biospectrumindia.com/news/22/16807/csir-laxai-life-sciences-focus-on-combined-treatment-for-covid-19.html https://biospectrumindia.com/news/22/16807/csir-laxai-life-sciences-focus-on-combined-treatment-for-covid-19.html Wed, 08 Jul 2020 06:10:00 +0530 Council of Scientific & Industrial Research (CSIR), in collaboration with Laxai Life Sciences Pvt. Ltd. Hyderabad, has sought regulatory approval to undertake four-arm randomized controlled phase III clinical trial. The design principle of the study is to rationally combine and repurpose antivirals (viral-entry and replication inhibitors) and host-directed therapies (HDTs) addressing the disease-spread and pathology simultaneously and to determine safety and efficacy of the three combination drugs (Favipiravir+Colchicine, Umifenovir+Colchicine and Nafamostat+5-ALA) and a control arm with the standard of care in COVID-19 patients. The clinical trial named MUCOVIN, to be carried out in the partnership with Medanta Medicity, will include a total of 300 patients in four different groups of 75 patients in the trials to be carried for 17 to 21 days including screening and treatment. Dr. Shekhar C. Mande, DG, CSIR highlighted that this unique combinatorial strategy (antivirals and HDTs) with repurposed drugs having complementary, additive and synergistic role, has been adopted to increase therapeutic options for Covid-19 treatment and help recover patients faster. The partner CSIR institutes in this important clinical trial are the CSIR-Indian Institute of Chemical Technology, Hyderabad and CSIR-Indian Institute of Integrative Medicine, Jammu. Dr. Ram S. Upadhayaya CEO, Laxai Life Sciences stated that “the study aims to target viral proteins essential for its replication as well as host factors that play crucial role in the viral life cycle and contribute to the cytokine storm”. Mr. Vamsi Maddipatla, MD of Laxai Life Sciences adds “The co-sponsorship of this study by Laxai Life Sciences highlights the company’s commitment in bringing life-saving therapies in the service of humanity”. These clinical trials add to the several contributions CSIR has made during the pandemic and if the trial is successful, it will provide more options for treatment of COVID-19. ]]> https://biospectrumindia.com/news/22/16792/govt-unveils-drug-discovery-hackathon-2020.html https://biospectrumindia.com/news/22/16792/govt-unveils-drug-discovery-hackathon-2020.html Fri, 03 Jul 2020 16:00:00 +0530 The Union Government has launched Drug Discovery Hackathon 2020. This is a joint initiative of MHRD’s Innovation Cell (MIC), All India Council for Technical Education (AICTE) and Council of Scientific and Industrial Research (CSIR) and supported by Centre for Development of Advanced Computing (CDAC), MyGov as well as private players. This Hackathon is first of its kind National initiative for supporting drug discovery process and will see participation from professionals, faculty, researchers and students from varied fields like Computer Science, Chemistry, Pharmacy, Medical Sciences, Basic Sciences and Biotechnology. Dr. Harsh Vardhan, Minister for S&T said, “We need to establish the culture of Computational Drug Discovery in our country. In this initiative, MHRD’s Innovation cell and AICTE will focus on identifying potential drug molecules through the Hackathon while CSIR will take these identified molecules forward for synthesis and laboratory testing for efficacy, toxicity, sensitivity and specificity.”  Pointing out that drug discovery is a complex, expensive, arduous and time-consuming process, Dr. Harsh Vardhan said, “While we pursue clinical trials of few repurposed drugs for COVID-19, as they are faster and can quickly be launched, it is also important that we find other suitable repurposed drugs while at the same time continue working on new drug discovery to develop specific drugs against COVID-19”. He added, “in-silico drug discovery which utilizes Computational methods such as Machine Learning (ML), AI and Big Data will help in accelerating this process”. Prof K. VijayRaghavan, PSA, Govt. of India said, “I wish to thank MHRD, AICTE and CSIR and all our partners for supporting this Hackathon which will help India establish new model for expediting drug discovery process. The Hackathon consists of challenges that are posted as problem statements and, are based on specific drug discovery topics which, are open to the participants to solve. It will have three phases of three months each and the whole exercise is to be completed by April-May 2021. At the end of each phase, successful teams will be rewarded. The ‘lead’ compounds identified at the end of phase 3 will be taken forward for experimental level at CSIR and other interested organizations." ]]> https://biospectrumindia.com/news/22/16773/govt-announces-scheme-to-accelerate-scientific-research.html https://biospectrumindia.com/news/22/16773/govt-announces-scheme-to-accelerate-scientific-research.html Thu, 02 Jul 2020 06:10:00 +0530 To provide a single platform for research internships, capacity building programs, and workshops across the country, the Science and Engineering Research Board (SERB), under the Department of Science and Technology, has launched a new scheme called ‘Accelerate Vigyan’ (AV). You can get more information on this scheme from its web portal www.acceleratevigyan.gov.in. Straight off the block, AV has already called for applications under its ‘ABHYAAS’ component for the Winter Season. The primary objective of this inter-ministerial scheme is to give more thrust on encouraging high-end scientific research and preparing scientific manpower, which can lead to research careers and knowledge-based economy. Recognizing that all research has its base as development of quality and well-trained researchers, AV will initiate and strengthen mechanisms of identifying research potential, mentoring, training and hands-on workshop on a national scale. “The vision is to expand the research base, with three broad goals, namely, consolidation / aggregation of all scientific programs, initiating high-end orientation workshops, and creating opportunities for research internships for those who do not have access to such resources / facilities,” said Dr Rajeev Mehajan, Advisor, SERB. The institution is also planning to launch an app for this in the coming two months. ]]> https://biospectrumindia.com/news/22/16763/govt-indicates-use-of-dexamethasone-for-covid-19-treatment.html https://biospectrumindia.com/news/22/16763/govt-indicates-use-of-dexamethasone-for-covid-19-treatment.html Wed, 01 Jul 2020 05:10:00 +0530 Keeping pace with evolving knowledge about COVID-19, especially in terms of effective drugs, the Union Ministry of Health & Family Welfare has  released an updated clinical management protocol for managing COVID-19 cases. The updated protocol includes the advice to use Dexamethasone as an alternative choice to Methylprednisolone for managing moderate to severe cases of COVID-19. The change has been made after considering the latest available evidence and expert consultation. Dexamethasone is a corticosteroid drug used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects. The drug has been tested in hospitalized patients with COVID-19 in the RECOVERY clinical trial and was found to have benefits for critically ill patients and has been shown to reduce mortality by about one third for patients on ventilators, and by about one fifth for patients being maintained on oxygen therapy. The drug is also a part of the National List of Essential Medicines (NLEM) and is widely available. The Union Health Secretary, Ms Preeti Sudan has forwarded the updated protocol with all States/UTs to make necessary arrangements for availability and use of the updated protocol and drug Dexamethasone at the institutional level also. The guidance document has also been made available online on the website of the Health Ministry. ]]> https://biospectrumindia.com/news/22/16702/cdri-receives-dcgi-approval-for-ph-iii-trials-of-umifenovir.html https://biospectrumindia.com/news/22/16702/cdri-receives-dcgi-approval-for-ph-iii-trials-of-umifenovir.html Wed, 24 Jun 2020 10:10:00 +0530 CSIR constituent lab CSIR-Central Drug Research Institute(CDRI) Lucknow, has received permission for carrying out Phase III randomised, Double blind, Placebo controlled trial of efficacy, safety and tolerability of antiviral drug Umifenovir. The Phase III Clinical Trials will be carried out at King George's Medical University (KGMU), Dr. Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) and ERA's Lucknow Medical College & Hospital, Lucknow. This drug has a good safety profile and acts by preventing entry of virus into human cells and also by priming the immune system. Umifenovir is mainly used for treatment of influenza and is available in China and Russia, and has recently come into prominence due to its potential use for Covid19 patients. To evaluate its efficacy in Indian patients, CSIR-CDRI has taken up the clinical trial. Further it has developed the process technology for Umifenovir in record time and licensed the economical process technology for manufacturing and marketing the drug to M/s. Medizest Pharmaceuticals Private Ltd. Goa, who have already received test license from DCGI. Prof.  Tapas Kundu, Director CSIR-CDRI, said that all the raw materials for the drug are indigenously available and if the clinical trial is successful, Umifenovir can be a safe, efficacious, affordable drug against COVID-19 and can be part of National Program against COVID-19. Prof. Kundu also added that this drug has the potential for prophylactic use. ]]> https://biospectrumindia.com/news/22/16681/dst-sets-up-joint-science-communication-forum.html https://biospectrumindia.com/news/22/16681/dst-sets-up-joint-science-communication-forum.html Wed, 17 Jun 2020 06:10:00 +0530 The Department of Science & Technology (DST) has constituted a joint Science Communication Forum with a view to facilitate interaction, cooperation, and coordination amongst various public sector science communication institutions and agencies. The Forum brings together science communication efforts spread across various institutions and can help adoption of a common policy and best practices at a wider scale, ultimately aiming towards a national science communication framework. It is represented by senior officials from various central ministries and departments, including Agriculture, Health, Culture, Defense, Space, Atomic Energy, and Information & Broadcasting, in addition to Science & Technology. Prof. Ashutosh Sharma, Secretary, Dept. of Science & Technology said that the forum would work upon strategies for effective planning and implementation of science communication programmes at macro and micro level in the country to spread scientific awareness and inculcate scientific temper amongst the masses leading to an innovation-driven society that contributes towards an ecosystem for Atmanirbhar Bharat. The forum would be served by a Secretariat at the National Council for Science & Technology Communication (NCSTC), Department of Science & Technology, which is mandated for coordination with different organizations, programmes and activities focused on science communication in the country and orchestrating them for enhanced public understanding of science with a scientific bent of mind. It is also mandated to formulate countrywide programmes, policies, and activities in the domain of science communication and popularization in the country. ]]> https://biospectrumindia.com/news/22/16628/csir-aim-sign-loi-to-foster-innovation-in-india.html https://biospectrumindia.com/news/22/16628/csir-aim-sign-loi-to-foster-innovation-in-india.html Wed, 10 Jun 2020 08:00:00 +0530 The Council of Scientific and Industrial Research (CSIR), a premier R&D organization with focus on science and technology that enables innovation-driven industry and nurture transdisciplinary leadership has come together with Atal Innovation Mission (AIM), a GoIflagship initiative to promote a culture of innovation and entrepreneurship have come together to collaborate in areas of mutual interest. Towards promoting innovation in the country in various sectors, a letter of intent was signed between the two organizations, in presence of Dr Rajiv Kumar, Vice Chairperson, Niti Aayog, Amitabh Kant, CEO of Niti Aayog and Dr Shekhar C Mande, DG CSIR and other senior officials from both the organizations. Major areas of mutual interest, among others include: Supporting world class start-ups through CSIR Incubators under Atal Innovation mission initiatives and jointly work on new models of innovation, including setting up of CSIR Innovation Parks. CSIR with its strong patent portfolio and knowledge base and world class researchers and AIM that has been working on policies for fostering innovation in different sectors of the economy together can boost and strengthen innovation ecosystem of the country.   Stimulating innovation and research in the MSME industry by CSIR in collaboration with ARISE.  In this context, while ARISE initiative of AIM, works to stimulate innovation and research in the MSME industry, CSIR has been working very closely with MSME where in many of its technologies and know-how have supported the MSME industry. Together they have the potential to transform and stimulate the MSME sector in the country.   Creating problem solving mind-set across schools in India through close   cooperation between Atal Tinkering Labs and Jigyasa. There is natural synergy between Atal Tinkering Laboratories that have been working to foster curiosity, creativity and imagination in young minds and CSIRs ´JIGYASA’ a Student-Scientist connect program where in >3 lakhs students across the country have been exposed to science and technology. The coming together of the two will enhance the opportunities for students and stimulate their scientific thinking and temperament.    The joint initiatives and collaboration will be implemented through development of Work Plans, which describe specifically the activities to be carried out under this collaboration. ]]> https://biospectrumindia.com/news/22/16622/india-australia-announce-special-covid-19-collaboration.html https://biospectrumindia.com/news/22/16622/india-australia-announce-special-covid-19-collaboration.html Mon, 08 Jun 2020 10:10:00 +0530 Prime Minister Narendra Modi and the Prime Minister of Australia, Scott Morrison MP, have jointly announced a special COVID-19 collaboration in 2020. Accordingly, Department of Science & Technology (DST), Ministry of Science & Technology, GOI and  Department of Industry, Science, Energy and Resources (DISER), Australia have invited joint research projects on COVID-19 from interested scientists and researchers under the Australia-India Strategic Research Fund (AISRF), a platform for bilateral collaboration in science, jointly managed and funded by the governments of India and Australia. The research proposals are expected to focus on antiviral coatings, other preventive technologies, data analytics, modeling, AI applications, and screening and diagnostic testing as priority areas. The project duration would be for 12 months with maximum extension of 6 months.  The objective of the grant opportunity is to fund short collaborative research projects with tangible outcomes focused on responding to the COVID-19 pandemic. The intended outcomes of the grant opportunity are to bring together leading research institutions and industry in both Australia and India currently working on areas relevant to COVID-19 such as vaccines, therapeutics, and diagnostics, and projects of a mutually beneficial nature whose outcomes contribute to the global response to the COVID-19 pandemic. ]]> https://biospectrumindia.com/news/22/16614/india-pledges-15-m-to-international-vaccine-alliance-gavi.html https://biospectrumindia.com/news/22/16614/india-pledges-15-m-to-international-vaccine-alliance-gavi.html Fri, 05 Jun 2020 20:00:00 +0530 India has pledged 15 Million US Dollars to Gavi, the international vaccine alliance. Prime Minister Narendra Modi was addressing the virtual Global Vaccine Summit hosted by UK Prime Minister Boris Johnson in which over 50 countries - business leaders, UN agencies, civil society, government ministers, Heads of State and country leaders participated. In his address the Prime Minister said India stands in solidarity with the World in these challenging times. Modi said, India’s civilization teaches to see the world as one family and that during this pandemic it had tried to live upto this teaching. He said India did it so by sharing the country’s available stocks of medicines with over 120 countries, by forging a common response strategy in its immediate neighborhood and by providing specific support to countries that sought it, while also protecting India’s own vast population. Prime Minister said the COVID19 pandemic, in someways, has exposed the limitations of global cooperation and that for the first time in recent history, the human kind faces a clear common enemy. Referring to Gavi, he said it is not just a global alliance but also a symbol of global solidarity and a reminder of that by helping others we can also help ourselves. He said India has a vast population and limited health facilities and that it understands the importance of immunization. Prime Minister said that one of the first programmes launched by his government was Mission Indradhanush, which aims to ensure full vaccination of the country’s children and pregnant women, including those in the remote parts of the vast nation. He said in order to expand protection, India has added six new vaccines to its National Immunization Programme. Prime Minister elaborated that India had digitized its entire vaccine supply line and developed an electronic vaccine intelligence network to monitor the integrity of its cold chain. These innovations are ensuring the availability of safe and potent vaccines in the right quantities at the right time till the last mile, he said. ]]> https://biospectrumindia.com/news/22/16596/govt-initiates-process-for-new-science-technology-and-innovation-policy.html https://biospectrumindia.com/news/22/16596/govt-initiates-process-for-new-science-technology-and-innovation-policy.html Wed, 03 Jun 2020 04:05:00 +0530 The Office of the Principal Scientific Adviser to the Government of India (Office of PSA) and the Department of Science and Technology (DST) have jointly initiated a decentralized, bottom-up, and inclusive process for the formulation of a new national Science Technology and Innovation Policy (STIP 2020). The fifth S&T policy of India is being formulated at a crucial juncture when India and the world are tackling the COVID-19 pandemic. This is only the latest among the many important changes in the past decade that have necessitated formulation of a new outlook and strategy for Science, Technology, and Innovation (STI). As the crisis changes the world, the new policy with its decentralized manner of formation will reorient STI in terms of priorities, sectoral focus, the way research is done, and technologies are developed and deployed for larger socio-economic welfare. The STIP 2020 formulation process is organised into 4 highly interlinked tracks: Track I involves an extensive public and expert consultation process through Science Policy Forum - a dedicated platform for soliciting inputs from larger public and expert pool during and after the policy drafting process. Track II comprises experts-driven thematic consultations to feed evidence-informed recommendations into the policy drafting process. Twenty-one (21) focused thematic groups have been constituted for this purpose. Track III involves consultations with Ministries and States, while Track IV constitutes apex level multi-stakeholder consultation. For Track III nodal officers are being nominated in States and in Ministries, Departments and Agencies of Government of India for extensive intra-state and intra-department consultation and for Track IV consultation with institutional leadership, industry bodies, global partners and inter-ministerial and inter-state consultations represented at the highest levels are being carried out. The consultation processes on different tracks have already started and are running in parallel. The Track-II thematic group (TG) consultation started with a series of information sessions last week. During the information sessions, Dr Akhilesh Gupta, Head of Policy Coordination and Programme Monitoring Division of DST, made the presentations and steered the discussions. The sessions were attended by around 130 members of the 21 thematic groups along with 25 Policy Research Fellows and scientists of DST and Office of PSA. “The STI Policy for the new India will also integrate the lessons of COVID-19 including building of an Atmanirbhar Bharat (self- reliance) through ST&I by leveraging our strengths in R&D, Design, S&T workforce and institutions, huge markets, demographic dividend, diversity and data,” said Prof Ashutosh Sharma, Secretary, DST The six-month process involves broad-based consultations with all stakeholders within and beyond the scientific ecosystem of the country –including academia, industry, government, global partners, young scientists and technologists, civic bodies, and general public. A Secretariat with in-house policy knowledge and data support unit, built with a cadre of DST-STI Policy fellows, has been set up at DST (Technology Bhavan) to coordinate the complete process and interplays between the four tracks. ]]> https://biospectrumindia.com/news/22/16590/govt-to-disinvest-in-certain-pharma-psus.html https://biospectrumindia.com/news/22/16590/govt-to-disinvest-in-certain-pharma-psus.html Tue, 02 Jun 2020 08:05:00 +0530 The Commerce and Industry Minister Piyush Goyal interacted with the captains of the Pharmaceutical industry, and Office-bearers of the Pharma Associations, through the Video Conference recently. The meeting was attended by the Ministers of State H.S.Puri and Som Parkash, Secretaries of the Department of Commerce, and Pharmaceuticals, and Officers from Departments of Commerce, Pharmaceuticals and Health. During his interaction, Goyal lauded the pharma industry for making India proud, by rising to the occasion during the Covid crisis. He said that India has been recognized as the ‘Pharmacy of the World’, as over 120 countries got some essential medicines, during the last two months, including 40 of them getting them in the form of grant, free of cost. He said that during the crisis, the officials of DGFT, MEA, Health and DoP burnt midnight oil to ensure that the export consignments are delivered at the earliest. The whole world appreciated India’s gesture, and this has swelled India’s goodwill and reputation. He said that India had adequate production capacity and abundant stock of HCQ and PCM for its projected domestic requirements, and putting restrictions on their exports was to ensure that the medicines are made available to all the needy nations, and no unscrupulous element stocks them for unwarranted gains. The Pharma industry received accolades from the Minister for their extra-ordinary performance, in ensuring that the Country did not face any type of shortage of medicines during this period.  Goyal said that early announcement of the Lockdown helped the country in preventing and containing the scourge of pandemic, and also scaling up the health infrastructure and build capacity, besides generating awareness among the people about the precautions and preventive measures. He said that India has set an example, under the able guidance and leadership of the Prime Minister Narendra Modi, in being pro-active in management of Covid-19, and also following it up with welfare and relief packages for mitigating its consequences. Goyal assured the industry that the Government will fully support the industry in its expansion, diversification and strengthening. He said that the industry has an important role to play in the Aatamnirbhar Bharat campaign. The country should become Aatmanirbhar in APIs as early as possible, as the government has taken a number of steps in this regard. It has already approved the scheme on Promotion of Bulk Drug Parks for financing Common Infrastructure Facilities in 3 Bulk Drug Parks. Also, Production Linked Incentive Scheme for promotion of domestic manufacturing of critical KSMs/Drug Intermediates and APIs in the country has been given a go ahead. The Minister said that anti-dumping investigation process has been expedited. The Minister said that in case of ongoing bilateral FTAs, if any roadblock or unfair competition is being noticed, the Government may be informed and prompt remedial action will be taken. He said they should look at large untapped market in Eastern Europe and Russia. Calling upon a collaborative route in the R&D efforts, Shri Goyal said the Academicians, Universities, ICMR and private sector should join hands. Informing the gathering that the Government has decided to disinvest in certain Pharma PSUs, the Minister invited the Indian companies to use PSUs for plug and play model of manufacturing. The Minister assured the industry that all suggestions presented in the meeting will be quickly examined and wherever required, the inter-ministerial consultations will be completed at the earliest. ]]> https://biospectrumindia.com/news/22/16489/ficci-lauds-the-strategic-reforms-announced-for-public-health-infrastructure.html https://biospectrumindia.com/news/22/16489/ficci-lauds-the-strategic-reforms-announced-for-public-health-infrastructure.html Tue, 19 May 2020 16:15:00 +0530 The industry body FICCI welcomes the steps announced by the Finance Minister for augmenting public health infrastructure in the country. These are long awaited reforms for addressing various challenges of the health sector that FICCI had been advocating for over past few years. While these are commendable steps towards Atma-nirbhar Bharat, it is crucial that they are put into immediate implementation so that their impact can be realized in next 3-5 years. The increase in public spending on healthcare should be increased to at least 2.5% of GDP, which has been assured in the National Health Policy 2017. The well-thought-out strategy for creating public-private infrastructure of hospitals, public funded labs across the country, emphasis on preparedness for infectious diseases at block level as well as greater importance to research and digital health will indeed form the pillars of growth for the sector. These are crucial for enhancing healthcare delivery across the continuum. Provision of 30% viability gap funding (VGF) for PPPs for hospitals in tier- II & III cities is also a welcome step. Last year, the government had announced the 20% VGF scheme, which has not seen many takers. It is important to understand that VGF for only capex is not viable for the healthcare sector, and should be considered for both capex as well as op-ex financing. However, all these announcements are only long-term steps that will help enhance the healthcare capacity of the country, but do not provide any respite from the crisis owing to the COVID-19 pandemic. The industry was hopeful of a relief package for the health sector that has faced acute financial as well as physical stress over the past couple of months. While the government has been considerate towards agriculture, one of the key pillars for economic growth of a country, but the health sector that is the epicenter of the ongoing crisis has been ignored. The hospitals that were already financially fragile over past few years, have been stressed with the unplanned investments for COVID-19 preparedness and response; and have seen their revenues topple due to 60-80% decline in patient footfalls, leading to estimated operational losses of 4500 crores per month (at 50% revenues and 35% occupancy levels). Many small hospitals and nursing homes in tier II & III cities had to down their shutters due to the challenges of liquidity and cash flow. FICCI has repeatedly recommended to the government for some immediate measures for the health sector to help bring them out of these severe headwinds. Some of these recommendations are: Support through Liquidity infusion for financing of the operating losses through short term interest free/ concessional interest rate loans to address the liquidity gap to the tune of Rs 14,000 -24,000 Cr Unutilized past MAT credit while transitioning to new Income tax regime Indirect tax reliefs/ exemptions/ waivers like- recoup amount equivalent to ineligible GST credits paid on procurements for a stipulated period Customs duty / GST exemption on essential medicines, consumables and devices for treatment of COVID patients Waiver or reduction of health-cess on all essential medical devices Extension of time for a period of 3 years needs to be provided under the EPCG scheme for fulfilment of existing export obligations for the healthcare sector given that international patient traffic flow has completely stopped At least 50% rebate on the current Commercial Rates of Power currently being paid by hospitals, to ensure sustenance of business     ]]> https://biospectrumindia.com/news/22/16479/health-ministry-ensuring-economy-reboot-via-st.html https://biospectrumindia.com/news/22/16479/health-ministry-ensuring-economy-reboot-via-st.html Mon, 18 May 2020 08:00:00 +0530 The Union Minister of Science & Technology, Earth Sciences and Health & Family Welfare, Dr. Harsh Vardhan said that India’s fight against the Covid-19 is moving fast ahead strongly and steadily. He was addressing a Digital Conference, RE-START – ‘Reboot the Economy through Science, Technology and Research Translations’, organised to celebrate the National Technology Day in New Delhi recently. The Conference was organised by the Technology Development Board (TDB) a statutory body of the Department of Science & Technology (DST) and Confederation of Indian Industry (CII). While applauding the Ministry of Science & Technology’s response to epidemics like COVID-19 in the country, Dr. Harsh Vardhan emphasized that the S&T response reflects the collaborative spirit of the entire S&T ecosystem. “Indian Government, academia, scientists, startups, entrepreneurs and industry have been working relentlessly to find solutions to combat this pandemic. We must appreciate the efforts of our scientists, our entrepreneurs and our institutions working to find quick and deployable solutions for Covid-19. New discoveries, industry partnerships, and enhanced researches have thus, been rapidly developed and adopted”, said the minister. “Within a short period of time, the nation has been able to mobilize a number of researchers to develop new testing kits, protective equipment, respiratory devices, etc”, he added. On the theme for the National Technology Day this year, Dr. Harsh Vardhan pointed out, “We need to mitigate the widespread economic impact and prepare for a stronger recovery using self-reliance as the new mantra. Thus, we look towards new opportunities to galvanize growth in the technological and industrial sector.”   ]]> https://biospectrumindia.com/news/22/16455/icmr-fast-tracks-roll-out-of-global-solidarity-trial-by-who.html https://biospectrumindia.com/news/22/16455/icmr-fast-tracks-roll-out-of-global-solidarity-trial-by-who.html Fri, 15 May 2020 06:35:00 +0530 The Indian Council for Medical Research (ICMR) has fast tracked the roll out of the global ‘Solidarity’ trial launched by the World Health Organization (WHO) to help in finding an effective treatment for COVID-19. ‘Solidarity’ is an international clinical trial to compare four treatment options against standard of care to assess their relative effectiveness against COVID-19. By enrolling patients in multiple countries, the Solidarity trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival. Importantly, this initiative provides for both speed and scale. Speaking  about  India’s  participation  in  this   global   endeavor,   Prof   (Dr)   Balram Bhargava, Secretary Department of Health Research and Director General ICMR said, “ICMR is working relentlessly to implement scientific interventions to combat the COVID-19 pandemic. The decision to join the WHO solidarity trial is an important step in this endeavor.” “The ICMR-National AIDS Research Institute (NARI) is the national coordination site for the trial in India. Four potential anti-viral agents, Remdesivir, Chloroquine/Hydroxychloroquine, Lopinavir-Ritonavir and Lopinavir-Ritonavir with Interferon (β1a) are to be trial,” he added. Welcoming India’s participation in the WHO global solidarity trial Dr Henk Bekedam, WHO Representative to India said, “We congratulate the Government of India, particularly ICMR for joining the global Solidarity trial. Through this collaboration, Indian researchers and institutions will participate in a global initiative to find effective treatment options for Covid-19. India plays a critical role in both research as well as in manufacturing once trials conclude successfully. WHO India is extending the required support to conduct the trial in India.” The trial has begun recruiting COVID-19  patients  in  the  country.  Elaborating  on  the progress, Dr Sheela Godbole, Senior Scientist, NARI and National Coordinator for the Solidarity trial in India said, “The required regulatory and ethical approvals have already been obtained and clinical trial sites have started to recruit patients in the trial.” Till now total 9 sites have been approved. The Solidarity trial provides simplified procedures to enable even overloaded hospitals to participate. Over 100 countries have requested participation to find effective therapeutics as soon as possible, via the trial. multiple countries will ensure time. This will help fast-track disease. The participation of multiple clinical trial units/hospitals in adequate enrollment of participants in the shortest possible identification of correct treatment options for the COVID-19 disease. ]]> https://biospectrumindia.com/news/22/16443/pm-cares-fund-allocates-rs-3100-cr-for-covid-19.html https://biospectrumindia.com/news/22/16443/pm-cares-fund-allocates-rs-3100-cr-for-covid-19.html Thu, 14 May 2020 10:10:00 +0530 PM CARES (Prime Minister’s Citizen Assistance and Relief in Emergency Situations) Fund Trust has decided to allocate Rs. 3100 Crore for fight against COVID-19. Out of Rs 3100 crore, a sum of approximately Rs.2000 crore will be earmarked for the purchase of ventilators, Rs. 1000 crores will be used for care of migrant labourers and Rs.100 crores will be given to support vaccine development.   The trust formed on 27th March 2020 is headed by Hon’ble Prime Minister (ex-Officio) and other ex-officio Members of the trust are Defence Minister, Home Minister and Finance Minister. While announcing this package, the Prime Minister has thanked all the donors for their generosity in contributing to the PM CARES Fund which will support India’s fight against COVID-19   50,000 Ventilators For augmenting the infrastructure to tackle COVID-19 casesacross the country,50000‘Made-in-India’ ventilators will be purchasedfrom PM CARES Fund at a cost of approximately Rs. 2000 Crores. These ventilators will be provided to government run COVID hospitals in all States/UTs,for better treatment of the critical COVID-19 cases.   Vaccine Development A vaccine against COVID-19 is the most pressing need and Indian academia, start-ups and industry have come together in cutting-edge vaccine design and development.To support the COVID-19 vaccine designers and developers, an amount of Rs. 100 Crore will be given from PM CARES Fund as a helping hand to catalyse vaccine development, which will be utilized under the supervision of Principal Scientific Advisor. ]]> https://biospectrumindia.com/news/22/16409/nbric-maps-reagents-consumables-makers-for-covid-19-rt-pcr-testing-kits.html https://biospectrumindia.com/news/22/16409/nbric-maps-reagents-consumables-makers-for-covid-19-rt-pcr-testing-kits.html Mon, 11 May 2020 08:45:00 +0530 National Biomedical Resource Indigenisation Consortium (NBRIC) has been constituted by the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India as a Public Private Partnership to drive indigenous innovation focused on developing reagents, diagnostics, vaccines and therapeutics for COVID-19. NBRIC begins mapping of manufacturers of reagents and consumables for COVID-19 RT-PCR testing kits.   If you are an Indian or India-based manufacturer of reagents and consumables for COVID-19 RT-PCR testing kits, please register at  https://bit.ly/2VcRnGl    The current call will build a nation-wide go-to repository for use by government and private organizations running RT-PCR tests.   Hosted and led by the Centre for Cellular and Molecular Platforms – C-CAMP, NBRIC aims to be a nation-wide collaborative platform for convergence of research, product resources and services towards developing reagents, diagnostics, vaccines, and therapeutics across India. NBRIC is a ‘A Make in India’ initiative for Biomedical research and innovative products, towards promoting import substitution and exports. The basic objectives of this initiative are to- Identify providers/manufacturing enterprises of crucial bio-medical resources Assess their current capabilities, capacities and requirements Support them by creating a enabling environment and connecting with policy makers and other stakeholders from public and private sectors Be the gateway for funding from DBT, BIRAC and DST for development or scaling      For more information on NBRIC see http://www.nbric.in/ ]]> https://biospectrumindia.com/news/22/16382/health-ministry-reviews-csirs-steps-to-beat-covid-19.html https://biospectrumindia.com/news/22/16382/health-ministry-reviews-csirs-steps-to-beat-covid-19.html Wed, 06 May 2020 09:00:00 +0530 The Minister for Science &Technology, Earth Sciences and Health & Family Welfare Dr Harsh Vardhan reviewed through video-conferencing the various initiatives CSIR has taken up in mitigation of Covid-19 in the country. DG CSIR Dr Shekhar C Mande apprised the Minister that CSIR has mounted a coordinated strategy involving all 38 CSIR labs and working in close coordination with industry and other agencies for implementation of the interventions and technologies at the ground level. CSIR has devised five verticals: Digital and Molecular Surveillance; Rapid and Economical Diagnostics; New Drugs / Repurposing of Drugs /Vaccines; Hospital Assistive Devices and PPEs; Supply Chain and Logistics Support Systems in order to develop requisite S&T based solutions to combat Covid19.  Significant developments in each of the five verticals, were presented by the Vertical Coordinating Directors.  During the interaction, Dr Harsh Vardhan also acknowledged that all CSIR labs are rising to the occasion and have supported people by supplying sanitizers, masks, ready to eat food apart from developing S&T based solutions. He exhorted the scientific departments, “to develop enhanced synergy and good quality coordination for quicker and better results. All Scientists and institutions should prioritise the requirements of the time and also contribute in finding quick and deployable solutions.” “I am happy to see the enthusiasm of CSIR scientists and that CSIR has made good progress since the last review”, he said.  He said affordability factor of various drugs, vaccines and other diagnostic & therapeutic equipment should also be considered. Dr Harsh Vardhan appreciated CSIR for submitting 53 sequences of COVID-19 genomes to the Global Coronavirus Genome Database, Global Initiative on Sharing All Influenza Data (GISAID).  “This is the result of a strong partnership between National Centre for Disease Control (NCDC), New Delhi and CSIR Institute of Genomics and Integrative Biology (CSIR-IGIB), representing the largest submission of sequences, by far from India by any group. The joint NCDC-CSIR program will accelerate molecular epidemiology and viral surveillance efforts of India,” he said. Dr Harsh Vardhan noted that Indian regulators are working to speed up regulatory process and CSIR supported clinical trials of Mw based Sepsivac by Industry has received approval for three clinical trials on Covid-19 affected patients and may offer relief to them. Another major development from the CSIR efforts is that for Remdesivir, a drug which has recently been approved by US-FDA for emergency use in Covid19 patients, synthesis of Key Starting Materials (KSMs) on kilo scale and gram scale synthesis of Remdesivir has been achieved by CSIR-IICT (Indian Institute of Chemical Technology) and technology demonstration to Indian industry is going on. For Favipiravir, another promising drug for Covid19, CSIR is working with private sector for clinical trials and launch in India. CSIR’s efforts in coming up with quick solutions to the shortages faced in various hospital devices and PPEs was also appreciated by the  Minister.  Especially noteworthy was that CSIR-NAL has come up with a BiPAP ventilator in a very short span of 35 days and is awaiting certification. CSIR-National Aerospace Laboratories (NAL) & MAFL have jointly developed a coverall and have received an order of 50,000 pieces from HLL and are gearing up to produce 30,000 pieces/day.  ]]> https://biospectrumindia.com/news/22/16380/as-lockdown-gets-extended-medical-device-sector-needs-urgent-govt-support-mtai.html https://biospectrumindia.com/news/22/16380/as-lockdown-gets-extended-medical-device-sector-needs-urgent-govt-support-mtai.html Tue, 05 May 2020 15:55:00 +0530 Supply of medical devices is an essential service to manage the COVID-19 pandemic in India but persistent financial and logistical bottlenecks are creating operational challenges for the sector. The situation has not improved much even after partial lifting of nationwide lockdown from 20th April, as a result of which factories and warehouses of our member companies are either shut or operating at 20-30% capacity. As the lockdown gets extended for another 2 weeks, these challenges will continue to impede the supply of medical devices unless the industry gets support from the government. Current hospital occupancy is only 30% because of restrictions on elective surgeries and demarcation of capacity for COVID-19 patients. As a result, the hospitals are facing a steep decline in revenue. This is having a domino effect on medical devices sector as its overall revenues are depressed deeply and its payments are not coming on time. This is compounded by a sharp increase in operational expenses for the Medtech sector. It is having to pay surge prices to transport medical devices to healthcare providers as only limited transportation facilities are available. Additional costs are being incurred on maintaining health safety of its workforce as well. Pavan Choudary, Chairman and Director General of Medical Technology Association of India said, “Medical devices sector has always been the backbone of in-patient healthcare. Despite numerous challenges, it has shown commitment and resilience in the face of adversity and has ensured uninterrupted supply of medical devices to hospitals. But the challenges are only increasing for the sector as it braces for the extension of the lockdown. There is an urgent need for intervention from the government to help the Medtech sector recover and continue fulfilling its role in ensuring critical care services in the country.” MTaI seeks following assistance from the government: Release pending payments to providers: We urge the government to release the pending payments, currently close to Rs 1,700 crore, to all healthcare service providers enrolled in healthcare schemes like Central Government Health Scheme and Rashtriya Swasthya Bima Yojana. There are cases where payment is pending for more than 5 years. The release of payment will facilitate the required cash-flow in the healthcare industry. Give tax exemptions: We request the government to consider giving tax and duty exemption (GST, Basic Customs Duty) to the medical device industry to cope with the liquidity challenges during this time. Revoke health cess: The government should revoke the additional 5% health cess on all medical devices or at least on those which are used in treatment of COVID-19 patients. More than 130 medical devices -from Specimen Collection & Management devices like swabs, Safety Arterial Blood Gas Syringes to in-patient devices like PPE, oxygen masks, catheters, cardiac monitors to infection control devices and respiratory care devices are used in COVID-19 treatment. Give loan assistance: Make zero interest working capital loans available where need be with the necessary collaterals to medical devices companies as the country needs a fully functioning Medtech sector to handle this health crisis.         ]]> https://biospectrumindia.com/news/22/16335/india-signs-1-5b-loan-with-adb-for-covid-19-response.html https://biospectrumindia.com/news/22/16335/india-signs-1-5b-loan-with-adb-for-covid-19-response.html Tue, 28 Apr 2020 16:00:00 +0530 The Government of India and the Asian Development Bank (ADB) have signed a $1.5 billion loan that will support the government’s response to the novel coronavirus disease (COVID-19) pandemic, focusing on immediate priorities such as disease containment and prevention, as well as social protection for the poor and economically vulnerable sections of the society, especially women and disadvantaged groups. The signatories to the loan agreement for the ADB’s COVID-19 Active Response and Expenditure Support Programme (CARES Programme) were Sameer Kumar Khare, Additional Secretary (Fund Bank and ADB), in the Department of Economic Affairs in Ministry of Finance, and Kenichi Yokoyama, Country Director, ADB, in India. Building on the CARES Programme, ADB is also in dialogue with the government for further possible support for stimulating the economy, support strong growth recovery, and to build resilience to future shocks. This includes the support for the affected industries and entrepreneurs particularly micro, small, and medium-sized enterprises (MSMEs) by facilitating their access to finance through credit guarantee schemes, MSME integration into global and national value chains through enterprise development centers, and a credit enhancement facility for infrastructure projects. Strengthening of public service delivery will be another important agenda, including the extension of comprehensive primary health services in urban areas, and of secondary and tertiary health care systems through PPP modalities. ]]> https://biospectrumindia.com/news/22/16280/taking-a-health-systems-approach-is-the-need-of-the-hour-tgi.html https://biospectrumindia.com/news/22/16280/taking-a-health-systems-approach-is-the-need-of-the-hour-tgi.html Wed, 22 Apr 2020 11:30:00 +0530 The George Institute for Global Health India welcomes the detailed guidelines on essential health services announced by the Union Ministry of Health and Family Welfare recently. The guidelines emphasise the need for ensuring that essential health services for non-COVID conditions are not neglected as additional activities for COVID-19 are scaled-up.   “It is heartening to note that the Government has acknowledged the need for continuing care for chronic and critically ill persons and providing other essential health services through the community health workers or Front Line Health Workers (FLHWs) like the ASHAs. In a policy note to the National Health Systems Resource Centre we have highlighted the need for a clear guidance for community health workers on essential services, services that can be postponed and additional COVID-19 activities,” says Dr. Soumyadeep Bhaumik, Research Fellow, The George Institute for Global Health, India. The policy note was prepared by The George Institute India researchers based on the global evidence from recent pandemics to understand issues and challenges for during COVID-19 and provided to NHRSC on 23rd March 2020. The note says engaging FLHWs like ASHA who continue to perform routine service delivery in identification and listing of COVID-19 patients, is not without its risk including that of transmission of COVID-19. “A role focussed on creating awareness and support for prevention and countering social stigma is better suited for FLHWs,” it argues. Also, the lockdown has affected delivery of several chronic services especially the provision of dialysis. The George Institute has been pointing out the need for continuing these services, and research staff of the Institute have been working closely with the district administration in Srikakulam to ensure that people are able to reach dialysis centres. “Centers that provide lifesaving dialysis treatment have been asked to shut down. The new guidance would help State Governments and local administration in devising mechanisms that can help continue such essential services,” says Prof Vivekanand Jha, Executive Director, George Institute for Global Health, India  The Institute has also been advocating the need to take a health systems approach to COVID-19 to ensure that preventing deaths due to COVID-19 does not come at the expense of deaths because of COVID-19. “These guidelines will ensure States strike a balance,” says Dr Bhaumik       ]]> https://biospectrumindia.com/news/22/16183/govt-sanctions-rs-15000-cr-for-covid-19-response-package.html https://biospectrumindia.com/news/22/16183/govt-sanctions-rs-15000-cr-for-covid-19-response-package.html Fri, 10 Apr 2020 08:10:00 +0530 Government of India (GoI) has announced significant investments to the tune of Rs.15000 crores for 'India COVID-19 Emergency Response and Health System Preparedness Package'. The funds sanctioned will be utilized for immediate COVID-19 Emergency Response (amount of Rs.7774 crores) and rest for medium-term support (1-4 years) to be provided under mission mode approach. The key objectives of the package include mounting emergency response to slow and limit COVID-19 in India through the development of diagnostics and COVID-19 dedicated treatment facilities, centralized procurement of essential medical equipment and drugs required for treatment of infected patients,  strengthen and build resilient National and State health systems to support prevention and preparedness for future disease outbreaks, setting up of laboratories and bolster surveillance activities, bio-security preparedness, pandemic research and proactively engage communities and conduct risk communication activities. These interventions and initiatives would be implemented under the overall umbrella of the Ministry of Health and Family Welfare. The Prime Minister in his address to the Nation on 24th March 2020 highlighted that - "The Central Government has provisioned Rs 15 thousand crore rupees for treating Coronavirus patients and strengthening the medical infrastructure of the country. This will allow for rapidly ramping up the number of Corona testing facilities, Personal Protective Equipment (PPE), Isolation Beds, ICU beds, ventilators and other essential equipment.  Simultaneously, training of medical and paramedical manpower will also be undertaken.  I have requested the State Governments to ensure that only healthcare is treated as their first and topmost priority now." The major share of the expenditure will be used for mounting robust emergency response, strengthening National and State health systems followed by strengthening pandemic research and multi-sector national institutions and platforms for One Health, community engagement and risk communication and implementation, management, capacity building, monitoring and evaluation component. M/o Health & Family Welfare is authorized to re-appropriate resources among components of the package and among the various implementation agencies (National Health Mission, Central Procurement, Railways, Dept of Health Research/ICMR, National Centre for Disease Control) as per the evolving emergent situation. MoHFW has been playing a lead role in executing the health sector response with containment and control as key response strategies. As on date, a total of 223 labs comprising a network of 157 government & 66 private laboratories are conducting rigorous screening process. Furthermore, MoHFW has already disbursed Rs. 4113 Crore to all the States and UTs for dealing with the emergency COVID response. ]]> https://biospectrumindia.com/news/22/16147/lifting-hcq-export-ban-a-boon-or-bane.html https://biospectrumindia.com/news/22/16147/lifting-hcq-export-ban-a-boon-or-bane.html Tue, 07 Apr 2020 16:15:00 +0530 India has eased restrictions on the export of anti-malarial drug hydroxychloroquine (HCQ) that is now being used as a possible treatment for COVID-19. In order to ensure adequate domestic supplies of the drug, India had initially banned its exports. Later on, when more than 10 countries requested the supply of HCQ, India had to make a decision. US President Trump had called Prime Minister Narendra Modi, requesting him to supply the anti-malaria drug as the number of cases continue to rise in the US. According to the National Pharmaceutical Pricing Authority (NPPA), India is capable of producing 40 metric tons of HCQ every month. The Department of Pharmaceuticals and Ministry of External Affairs is yet to decide on the allocations of the drug to different countries. Meanwhile, the government has placed orders for the drug supply to Ipca laboratories and Zydus Cadila. On the other hand, the industry is appealing to the government to reconsider this lifting of the ban. Eventually, an escalation in domestic demand might lead to a shortage in the drug supply in India. ]]> https://biospectrumindia.com/news/22/16088/ayush-ministry-to-work-on-scientific-solutions-for-covid-19.html https://biospectrumindia.com/news/22/16088/ayush-ministry-to-work-on-scientific-solutions-for-covid-19.html Tue, 31 Mar 2020 17:00:00 +0530 In follow-up to the call given by the Prime Minister to help stop big claims without evidence-support about treatment of COVID 19, the Ministry of AYUSH has initiated steps to curb such claims through creation of awareness. Further, the Ministry also initiated action on the Prime Minister’s advice to work for scientific evidence-based solutions from the AYUSH systems to restrain the spread of the pandemic by setting up a channel to enlist various suggestions and proposals from AYUSH practitioners and AYUSH institutions, and having them examined for viability through a Group of Scientists. The Ministry is using platforms like video conferencing and social media to reach out to AYUSH practitioners and involve them in stopping and discouraging false and unsupported claims. In a video conference held on 30th March 2020, nearly hundred thought leaders from different disciplines of AYUSH participated, and among other things, also resolved to work for spreading awareness against such inappropriate claims.  One of the follow up action being initiated by the Ministry of AYUSH on the PM’s call to work for scientific evidence-based solutions from the AYUSH systems is to set up an online channel on its website for receiving suggestions based on scientific explanations and proposals on therapies and procedures prepared based on standard scientific guidelines that could restrain the spread of the Covid -19 pandemic, or to manage the disease. The Ministry has accordingly invited inputs from AYUSH practitioners and AYUSH institutions (institutions may include colleges/ universities, hospitals, research institutes, AYUSH manufacturers, AYUSH associations etc.). The inputs can be submitted on the Ministry’s website at the following link: http://ayush.gov.in/covid-19  The inputs received will be scrutinised by a Committee of Experts. Those proposals recommended by the Scrutiny Committee will be further vetted by a group of scientists from diverse specialties. Wherever possible, those proposals may be taken up for validation studies ]]> https://biospectrumindia.com/news/22/16042/dst-sets-up-covid-19-task-force.html https://biospectrumindia.com/news/22/16042/dst-sets-up-covid-19-task-force.html Fri, 27 Mar 2020 11:10:00 +0530 The Department of Science and Technology (DST) is coordinating an effort to upscale appropriate technologies and manufacturing available in India for addressing a plethora of issues related to COVID-19, as well as scout for new and developing solutions more relevant to the country to help prepare the country for exigencies arising out of COVID-19 pandemic. DST has set up a COVID 19 Task force for mapping of technologies from R&D labs, academic institutions, startups, and MSMEs to fund nearly market-ready solutions in the area of diagnostics, testing, health care delivery solutions, equipment supplies. Some of these solutions include masks and other protective gear, sanitizers, affordable kits for screening, ventilators and oxygenators, data analytics for tracking, monitoring, and controlling the spread of outbreak through AI and IOT based solutions, to name a few. The capacity mapping group consists of representatives from DST, Department of Biotechnology (DBT), Indian Council for Medical Research (ICMR), Ministry of Electronics and Information Technology (MeitY), Council for Scientific and Industrial Research (CSIR), Atal Innovation Mission (AIM), Ministry of Micro, Small and Medium Enterprises (MSME), Startup India and All India Council for Technical Education (AICTE). The Task Force is to identify the most promising startups that are close to scale up, who may need financial or other help or connects or projected demand to rapidly scale up.  Nodal officers of concerned Ministries and Departments have been requested to personally expedite the process of obtaining information on startups and other entities supported by them that have technology solutions for any important aspect of COVID-19. As part of the mechanisms being used for rapid development, manufacturing, and deployment of relevant technology options, DST has already invited two separate sets of proposals, one each under Science & Engineering Research Board (SERB) and Technology Development Board (TDB), to support scientific solutions and commercial manufacturing of both new and existing solutions. ]]> https://biospectrumindia.com/news/22/16037/immediate-need-for-fiscal-intervention-for-covid-19-impact-healthcare-industry.html https://biospectrumindia.com/news/22/16037/immediate-need-for-fiscal-intervention-for-covid-19-impact-healthcare-industry.html Thu, 26 Mar 2020 16:15:00 +0530 Healthcare Industry jointly represented by FICCI, AHPI, ASSOCHAM, Indian Chamber of Commerce, PhD Chamber of Commerce, PHANA Karnataka and NATHEALTH has announced some key recommendations that emphasizes on the immediate need for Fiscal and Non-Fiscal Interventions from Government required for the Sector to deal with COVID-19 impact. While greatly appreciating Government’s efforts to contain the Covid-19 outbreak, the healthcare industry leaders cutting across entire industry spectrum have urged upon the government to come forward with fiscal intervention to arrest the adverse impact on the economy and thereby on human lives. The Industry leaders recommended both fiscal and non-fiscal interventions for several sectors which focus on the Service sector, especially Hospitals, Diagnostics, Pathology Labs, Med Tech, Insurance, Home Care and other healthcare service providers. “The services sector, which accounts for about 55% of India’s gross domestic product, is poised to be the worst hit due to actions such as mandatory and self-imposed curfew. The social distancing measures would lead to lower footfalls in the healthcare sector, the decline in elective procedure volume and sub-optimal operating efficiencies that will have a severe impact on the cash flows of companies in the capital-intensive sector. The industry is also suffering from reduced availability & elevated pricing observed for certain essential consumable items,” the Representation to the government pointed out. “Also, the global supply chains are in turmoil driving up shortages and a significant hike in input costs which cannot be passed on to consumers as healthcare services are exempt from GST and many of the critical items are capped in prices, resulting in a body blow to this sector which will now be pivotal for a turnaround in the fight against COVID-19. Apart from the healthcare facilities, medical devices, diagnostics and health insurance have also been affected due to the supply-chain and demand disruptions,” it said. Covid -19 needs all health workers to be motivated and secured as a united front. Health Services including Hospitals, Nursing Homes, Diagnostic Labs and Homecare, these segments need immediate fiscal intervention. Industry leaders strongly recommended the government to ensure working capital and that would the hospitals continue to operate at near-normal levels and patients - both void-19 and others can avail the services. The industry called for six to nine months’ moratorium on all working capital, principal, interest payments on loans and overdrafts, bringing in liquidity and allowing for business continuity. Dubbing it as a critical fiscal intervention, the healthcare industry sought short-term interest-free loans for augmenting capacity, and to ensure smooth hospital operations without supply-chain disruptions. The government also was requested to examine Grant or Subsidy to as an interim market support mechanism. To maintain operational expenditure including payment of salaries to health professionals on time, the Industry suggested cash flow to the government should immediately release 100 per cent Central and State Government dues to the sector under various schemes such as CGHC, ECHS, State Schemes, GIPSA among other. The Representation also seeks urgent release of Income Tax refunds and to allow a quarter's postponement on compliances, payment of insurance without the policies getting lapsed. The Healthcare leaders said that a waiver of GST on input costs and services for two quarters would help enormously. “This would also ensure that hospitals are not forced to curtail the outsource services like House Keeping, Security and F&B (all of which have significant GST levies), in turn causing loss of jobs people employed in those sectors. Deferment of pre-payment of loan for 12 months should be allowed. Deferment of advance tax payments at the Central Government level would also be a significant fiscal intervention,” they said in the unified representation. For Medical Devices industry, the Representation calls for cut down custom duty across the board for life-saving medical equipment and set up a credit window facility that can help us augment infrastructure during this period of great turmoil. It also suggested withdrawal of Health Cess Ad Valorem from Medical Devices so that the Health Cess will apply only to Basic Customs Duty. For the Medical Device industry also the healthcare emphasised that Government should clear all outstanding and make timely payment for upcoming procurements from government Institutions in the current crisis, which will go a long way in supporting med-tech companies. The industry leaders are of the view that along with fiscal incentives and support, non-fiscal interventions would be equally critical. “Further to the Ministry of Health guidelines on home quarantine and telemedicine, the government should also issue standard guidelines for Home Healthcare Providers notifying them under ambit of Clinical Establishment act, as they can contribute by remote monitoring of cases by monitoring patients for symptoms in-home quarantine, patients in E-ICU beyond metros, cases recovering from COVID-19 and preventing or managing relapse,” the Representation paper said. The Industry Representation also provided a comprehensive roadmap for incentives and promotional policies for Skill Development, Medical Education, Pharma and E-learning. Other Key Recommendations  GST waiver for online education and interest subsidies The impetus to online teaching & Support for setting up of skill labs and simulation centres at the medical college/ teaching hospital Increase the number of healthcare professionals across the gamut in our country by Tripling the intake of nursing students from current levels In medical colleges, some relaxations to be considered vide Standard Requirements Guidelines during this period The system should be in place to ensure there are no blockages in Manufacturing Essential Pharmaceutical products including Hand Sanitizers, Face Masks etc. Also PHARMA testing Laboratories should be rapidly expanded and made fully operational. Other Critical Non-Fiscal Recommendations  Create a nodal department on a war footing for MSMEs where all the queries related to essential supplies for Covid19 can be directed to for immediate action. Notification to be issued for procurement by the government on a direct basis, based on specifications and previous supply credentials, and not through HLL/tendering Allow a preferential clearance of medical devices/ spare parts/ raw materials in airports and seaports. A very large backlog is expected post international flight landing restrictions which will result in delaying customs clearance. Fast track regulatory approval for diagnostic kits and new drugs identified for COVID 19 (eq. hydroxy chloroquine is now approved by USFDA for COVID Explore other available testing technologies beyond RT PCR to enhance access in masses. Health Insurance: Government to provide relief for GST payable and reduce it to 5% so that more people would be able to afford to buy Health Insurance especially the senior citizens aged 60 and above.   ]]> https://biospectrumindia.com/news/22/16031/mtai-urges-states-to-implement-centres-order-on-free-movement-of-medical-devices.html https://biospectrumindia.com/news/22/16031/mtai-urges-states-to-implement-centres-order-on-free-movement-of-medical-devices.html Thu, 26 Mar 2020 12:10:00 +0530 Medical Technology Association of India (MTaI), which represents research-based medical technology companies that have a large footprint in manufacturing, R&D and healthcare worker training in India, is in constant engagement with the government to tackle the current COVID-19 situation in India. Pavan Choudary, MTaI Chairman and Director General said, “Till the time a vaccine is developed, medical technology will shoulder the fight against COVID-19 as coronavirus patient management will almost exclusively depend on medical devices such as ventilators, haemodynamic monitors, respirators, catheters, Personal Protective Equipment (PPE), imaging, and diagnostics until recovery.” As this pandemic has spread across countries, paralyzing economies and healthcare systems, availability of medical devices such as ventilators, N95 masks, diagnostic kits, PCR kits and infrared thermometers is falling short of requirements. “We need to think out of the box and come up with suitable and readily available alternatives to handle the shortages. MTaI is engaged with the government at the highest levels to share its knowledge of such substitutes and emerging global protocols,” said Mr Choudary. In the current situation, quick movement of medical equipment is paramount for timely diagnosis, monitoring and treatment of patients suffering from COVID-19 and other critical ailments. However, manufacturers and distributors of crucial medical devices are facing several logistical challenges due to restrictions on inbound passenger flights and as well as movement of vehicles between cities and states. Sanjay Bhutani, MTaI Director said, “Most medical devices are shipped through international passenger flights. However, with flight restrictions in place, such shipments have to solely depend on cargo flights. As a result of this, cargo clearances have slowed down and a huge backlog is witnessed at customs. MTaI has been engaged with the government ever since the first sparks of the virus flew. The Central Government understands the critical role of medical devices in COVID-19 management. Various central ministries have initiated supportive actions.” “The Secretary, Department of Pharmaceuticals has expeditiously sent a letter to Chief Secretaries of all states exempting medical device operations from the lockdown (enclosed in annexure). However, either the state machinery is not as agile as the Centre or is confused by different directives related to varied industries. This is why the industry is still facing several crippling issues that are impacting movement of vital medical devices, equipment and diagnostics,” added Mr. Choudary. The directive given by the government to apply for individual passes for employees is a tedious process and will take up precious time which can be alternatively invested in manufacturing, supply and service operation of these essential products. The lockdown is majorly affecting courier agencies like Bluedart, SafeExpress, and FedEx which are not allowed to move freely even while carrying medical devices. If the logjam continues, hospitals could face an acute scarcity of medical devices very soon. To avoid a crisis and preserve the medical supply chain, MTaI requests government’s urgent intervention to ensure the following: Preferential customs clearance for inbound cargo of medical devices having HSN code 9018, 9019, 9020, 9021 and 9022. Exemption for medical device workers and service engineers from lockdown/curfew based on self-declaration of identity and adherence to safety measures. Directions to police and other authorities who are managing border check posts to allow movement of courier companies who carry medical devices to hospitals and diagnostic centres.     ]]> https://biospectrumindia.com/news/22/16036/finance-minister-announces-rs-50-lakh-insurance-cover-in-covid-19-battle.html https://biospectrumindia.com/news/22/16036/finance-minister-announces-rs-50-lakh-insurance-cover-in-covid-19-battle.html Thu, 26 Mar 2020 00:00:00 +0530 The Union Finance & Corporate Affairs Minister Niramla Sitharaman has announced Rs 1.70 Lakh Crore relief package under Pradhan Mantri Garib Kalyan Yojana for the poor to help them fight the battle against Corona Virus. While addressing the press conference in New Delhi, the Finance Minister said “Today’s measures are intended at reaching out to the poorest of the poor, with food and money in hands, so that they do not face difficulties in buying essential supplies and meeting essential needs.” The FM has also announced insurance scheme for health workers fighting COVID-19 in Government Hospitals and Health Care Centres- Safai karamcharis, ward-boys, nurses, ASHA workers, paramedics, technicians, doctors and specialists and other health workers would be covered by a Special insurance Scheme. Any health professional, who while treating Covid-19 patients, meet with some accident, then he/she would be compensated with an amount of Rs 50 lakh under the scheme. All government health centres, wellness centres and hospitals of Centre as well as States would be covered under this scheme  approximately 22 lakh health workers would be provided insurance cover to fight this pandemic. District Mineral Fund The State Government will be asked to utilise the funds available under District Mineral Fund (DMF) for supplementing and augmenting facilities of medical testing, screening and other requirements in connection with preventing the spread of COVID-19 pandemic as well as treating the patients affected with this pandemic.   ]]> https://biospectrumindia.com/news/22/16011/cabinet-approves-promoting-domestic-manufacturing-of-medical-devices.html https://biospectrumindia.com/news/22/16011/cabinet-approves-promoting-domestic-manufacturing-of-medical-devices.html Tue, 24 Mar 2020 10:10:00 +0530 The Union Cabinet chaired by the Prime Minister, Narendra Modi has approved the following schemes: The scheme on Promotion of Medical Device Parks for financing Common Infrastructure Facilities in 4 Medical Device Parks with financial implications of Rs. 400 crore. The   Production   Linked   Incentive (PLI) Scheme   for   promoting   domesticmanufacturing of medical devices with financial implications of Rs. 3,420 crore. The expenditure to be incurred for the above schemes will be for the next five years i.e. from 2020-21 to 2024-25. Promotion of Medical Device Parks Medical Device is a growing sector and its potential for growth is the highest among all sectors in the healthcare market. It is valued at Rs. 50,026 crore for 2018-19 and is expected to reach to Rs. 86,840 crore by 2021-22. India depends on imports up to an extent of 85% of total domestic demand of medical devices. The Scheme aims to promote Medical Device Parks in the country in partnership with the States. A maximum grant-in-aid of Rs.100 crore per park will be provided to the States. Production Linked Incentive Scheme The Medical Device sector suffers from a cost of manufacturing disability of around 12% to 15%, vis-a-vis competing economies, among other things, on account of lack of adequate infrastructure, domestic supply chain and logistics, high cost of finance, inadequate availability of quality power, limited design capabilities and low focus on R&D and skill development, etc. There is, thus, a need for a mechanism to compensate for the manufacturing disability. The Scheme aim to boost domestic manufacturing by attracting large investments in medical device sector. Under the Scheme, incentive @ 5% of incremental sales over base year 2019-20 will be provided on the segments of medical devices identified under the Scheme. Implementation: The Scheme for Promotion of Medical Device Parks will be implemented by a State Implementing Agency(SIA). The PLI Scheme for promoting domestic manufacturing will be implemented by a Project Management Agency (PMA) to be nominated by Department of Pharmaceuticals. The target is to provide financial assistance for Common Infrastructure Facilities for 04 Medical Device parks. The target for PLI Scheme is to provide assistance to about 25-30 manufacturers under the following categories of medical devices: - Cancer care/Radiotherapy medical devices, Radiology & Imaging medical devices (both ionizing & non-ionizing   radiation products) and Nuclear Imaging Devices, Anesthetics & Cardio-Respiratory medical devices including Catheters of Cardio Respiratory Category & Renal Care Medical Devices and AII Implants including implantable electronic devices like Cochlear Implants and Pacemakers.   Impact: Under the sub-scheme for Promotion of Medical Device Parks, Common Infrastructure Facilities would be created in 4 Medical Device Parks, which is expected to reduce manufacturing cost of medical devices in the country. ]]> https://biospectrumindia.com/news/22/16004/cabinet-approves-development-of-3-mega-bulk-drug-parks.html https://biospectrumindia.com/news/22/16004/cabinet-approves-development-of-3-mega-bulk-drug-parks.html Mon, 23 Mar 2020 12:00:00 +0530 The Union Cabinet chaired by the Prime Minister, Narendra Modi has approved the following schemes: The scheme on Promotion of Bulk Drug Parks for financing Common Infrastructure Facilities in 3 Bulk Drug Parks with financial implication of Rs. 3,000 crore for next five years. Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical KSMs/Drug Intermediates and APIs in the country with financial implications of Rs6,940 crore for next eight years. Promotion of Bulk Drug Parks Decision is to develop 3 mega Bulk Drug parks in India in partnership with States. Government of India will give Grants-in-Aid to States with a maximum limit of Rs. 1000 Crore per Bulk Drug Park. Parks will have common facilities such as solvent recovery plant, distillation plant, power & steam units, common effluent treatment plant etc. A sum of Rs. 3,000 crore has been approved for this scheme for next 5 years. Production Linked Incentive Scheme Financial incentive will be given to eligible manufacturers of identified 53 critical bulk drugs on their incremental sales over the base year (2019-20) for a period of 6 years. Out of 53 identified bulk drugs, 26 are fermentation based bulk drugs and 27 are chemical synthesis based bulk drugs. Rate of incentive will be 20 % (of incremental sales value) for fermentation based bulk drugs and 10% for chemical synthesis based bulk drugs. A sum of Rs. 6,940 crore has been approved for next 8 years. The scheme is expected to reduce manufacturing cost of bulk drugs in the country and dependency on other countries for bulk drugs. ]]> https://biospectrumindia.com/news/22/15967/e-cigarettes-provide-smokers-with-an-option-to-get-away-from-smoking-caphra-.html https://biospectrumindia.com/news/22/15967/e-cigarettes-provide-smokers-with-an-option-to-get-away-from-smoking-caphra-.html Tue, 17 Mar 2020 11:15:00 +0530 An Asian alliance of tobacco harm reduction advocacy organizations has urged India' Ministry of Health and Family Welfare to bring up the rights of smokers who want to switch to safer alternatives during the Ninth Session of Parties (COP9) of the World Health Organisation's Framework Convention on Tobacco Control (WHO-FCTC) which will be held in November 2020. The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) also asked India's health minister to question the restrictive policy of WHO that tolerates the use of combustible cigarettes, while discouraging the use of 95-percent less harmful smoke-free Electronic Nicotine Delivery Systems (ENDS). CAPHRA sent separate letters this month to Asian health ministers who will lead the preparation of their countries' position on ENDS, preparatory to the COP9 of WHO-FCTC. There are 181 parties to the WHO-FCTC - a global treaty that seeks to protect present and future generations from the devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke. CAPHRA said tobacco use causes a million deaths per year in the Asia Pacific region, with smoke as the main culprit. It said, however, that e-cigarettes provide smokers with an option to get away from smoking and could hasten the demise of the cigarette. CAPHRA said that as the FCTC has a mandate to pursue “harm reduction” as a core tobacco control policy, it has failed to acknowledge or implement this policy over the last 18 years. It has effectively deprived smokers of an effective way out of smoking, according to the coalition. CAPHRA also noted that the successive FCTC-COPs had refused to consider the overwhelming scientific evidence proving ENDS to be a much less harmful alternative to smoking and an extraordinarily effective smoking cessation strategy that has worked for millions of smokers in developed countries. “It is a violation of the human rights of all smokers and current users of safer nicotine products, to ban or restrict access to these products and it goes against the mandate of the WHO FCTC Article 1 that clearly outlines a two-pronged approach to the global tobacco crisis that includes a harm reduction approach,” CAPHRA said. The coalition, therefore, asked Asian health ministers to bring to FCTC-COP9 discussion the consumers' rights to choose less harmful products as a way to protect themselves from smoke. India's central government imposed a ban on the sale and advertisement of vaping products in 2019 and threatened penalties of up to three years in prison. While the use and possession of vaping devices are exempt from the ban, this is not clarified at various levels of the government. CAPHRA said that with appropriate regulations, India's Ministry of Health and Family Welfare has an opportunity to help millions of smokers switch to safer alternatives such as smoke-free e-cigarettes, heat-not-burn tobacco and snus. “Nicotine is not the enemy, it is smoke, and tar and the other by-products of combustion. Yet this government continues to permit the sale and use of the obviously most dangerous nicotine product (smoking cigarettes) alongside certain alternative nicotine products while refusing to acknowledge the benefits of allowing smokers to switch to other novel nicotine products that are now known to be both far safer and also more effective in aiding smokers to stop using combustible tobacco,” CAPHRA said. “As consumers and voters, we ask you to consider allowing citizens of this country to choose non-pharmaceutical, non-combustible interventions that provide users with the nicotine they enjoy without the smoke and tar, such as ENDS (popularly known as 'e-cigarettes' or 'vaping'), which have been chosen and used by millions of consumers worldwide to easily, effectively and permanently switch from smoking combustible tobacco,” it said. CAPHRA also asked India's delegates to COP9 to deplore the policy of FCTC to make its sessions closed-door, unaccountable and unreported. It said such sessions represented only the vested interests of some groups whose actions have thus far impeded the rights of citizens and voters to choose for themselves to switch to safer alternatives to deadly smoking. “Delegates to COP9 should be representing the rights and aspirations of the citizens whose taxes are paying for their attendance, who expect them to speak on their behalf, acknowledge the science underpinning the harm reduction benefits of ENDS, and maintain democratic principles,” the coalition said. “Consumers and voters have the right to make choices that help them avoid adverse health outcomes and smokers have the right to access less harmful nicotine products as alternatives to smoking. We ask you to take into account of this right when making your submission to COP9,” CAPHRA said. ]]> https://biospectrumindia.com/news/22/15960/india-proposes-covid-19-emergency-fund-for-saarc-countries.html https://biospectrumindia.com/news/22/15960/india-proposes-covid-19-emergency-fund-for-saarc-countries.html Mon, 16 Mar 2020 10:30:00 +0530 Prime Minister Narendra Modi interacted with the leaders of the SAARC countries through video conference to chart out a common strategy in order to combat COVID-19 in the region. In the spirit of collaboration, Prime Minister Modi proposed creation of a COVID-19 Emergency Fund based on voluntary contributions from all the countries, with India making an initial offer of US $10 million for the fund. The fund can be used by any of the partner countries to meet the cost of immediate actions. He informed that India is assembling a Rapid Response Team of doctors and specialists, along with testing kits and other equipment, which will be on stand-by, to be placed at the disposal of the countries, if required. Prime Minister also offered arranging for online training capsules for the emergency response teams of the neighbouring countries and sharing of software behind India’s Integrated Disease Surveillance Portal to help trace possible virus carriers and the people they contacted. He suggested that existing mechanisms like  SAARC Disaster Management Centre can be used to pool in best practises. He also suggested creation of a common Research Platform to coordinate research on controlling epidemic diseases within the South Asian region. He suggested further brainstorming by experts on the long-term economic consequences of COVID-19, and how best to insulate internal trade and local value chains from its impact. ]]> https://biospectrumindia.com/news/22/15924/dop-to-form-pharma-bureau-to-support-govt-industry.html https://biospectrumindia.com/news/22/15924/dop-to-form-pharma-bureau-to-support-govt-industry.html Fri, 06 Mar 2020 14:45:00 +0530 The Department of Pharmaceuticals (DoP), under the Ministry of Chemicals and Fertilizers, Government of India, has announced the launch of Pharma Bureau- a body of technical experts, which will act as a single-point interface for the pharmaceutical and medical devices industry for issues relating to the Government of India and various State Governments. The Bureau will coordinate with different ministries of the Central Government as well as the State Governments for providing solutions to the Industry in a time bound manner. In partnership with Invest India, the National Investment Promotion and Facilitation Agency that helps investors looking for investment opportunities and options in India, the Bureau will also help facilitate both foreign as well as domestic investment in the Pharmaceutical and Medical devices industry in India. The bureau will also act as a policy think tank to support the Government as well as the Industry. ]]> https://biospectrumindia.com/news/22/15903/govt-restricts-drug-exports-as-coronavirus-threat-rises-.html https://biospectrumindia.com/news/22/15903/govt-restricts-drug-exports-as-coronavirus-threat-rises-.html Thu, 05 Mar 2020 10:30:00 +0530 As per the recent notification by Directorate General of Foreign Trade, it is restricting the export of 26 active pharmaceutical ingredients (APIs) and drug formulations used as raw materials to manufacture crucial drugs until further notice, to prevent shortages amid concerns of the coronavirus outbreak  in India. The notification states amendment in the export policy of these APIs and formulations made out of these APIs. The list includes paracetamol, Vitamins B1, B6, B12, female hormone drug Progesterone, antibiotics used to treat vaginal infections like Tinidazole and Metronidazole, a drug used to treat herpes Acyclovir, and other antibiotics like Chloramphenicol, Erythormycin Salts Neomycin, Ornidazole and Clindamycin. India confirmed three positive cases of coronavirus recently in Delhi, Telangana and Jaipur. Though India is a source of about 20% of the world’s generic drug supply, pharma companies in the country are dependent on China for two-thirds of the chemical components needed to make them.     ]]> https://biospectrumindia.com/news/22/15902/dop-ensures-drug-security-to-handle-coronavirus-outbreak.html https://biospectrumindia.com/news/22/15902/dop-ensures-drug-security-to-handle-coronavirus-outbreak.html Wed, 04 Mar 2020 00:00:00 +0530 Department of Pharmaceuticals has constituted a committee under the chairmanship of Dr. Eshwara Reddy, Joint Drugs Controller, Central Drugs Standard Control Organization (CDSCO) to address the issues of drug security in the country in the context of Novel Coronavirus outbreak in China. The committee, in its report, has mentioned that the present stock-inhand of the APIs may be sufficient for 2 to 3 months to manufacture formulations and also given certain recommendations.  The committee further mentioned that  there is no need to panic so far as drug security is concerned. Based on the recommendations of the Committee, the department has issued necessary instructions to National Pharmaceutical Pricing Authority (NPPA), Drugs Controller General of India (DCGI) and State Governments to ensure adequate supply of APIs and formulations at affordable prices in the market and to prevent black-marketing, illegal hoarding, creating artificial shortages in the country. NPPA has also written to Chief Secretaries of States with copies to Principal Secretaries Health and State Drug Controllers requesting them to closely monitor the production and availability of APIs and formulations to prevent the black marketing and hoarding in their States and UTs as well as to ensure that there is no violation of provisions of Drugs (Prices Control) Order, 2013 with regard to compliance of ceiling prices/ permissible increase in prices of scheduled/ non-scheduled formulations respectively. In this regard, Department of Pharmaceuticals has written to DGFT to restrict exports of 13 API and formulations made using these APIs. These APIs are primarily made in Hubei province of China. As per the latest available information, most of the Chinese companies manufacturing pharmaceutical ingredients (excluding those in Hubei province) have now resumed operations partially and expected to resume fully by end of March. There are no restrictions on the export of APIs from China. The Chinese companies are willing to export to India, however logistics sector has not yet resumed operations fully. It is observed from Port offices of CDSCO that APIs are being imported from China. As per the information received from port offices of CDSCO, 56 consignments of APIs are imported during 26th and 27th Feb 2020. Out of 56, 40 consignments are from China and rest are from countries other than China. ]]> https://biospectrumindia.com/news/22/15888/karnataka-to-formulate-new-policy-on-st.html https://biospectrumindia.com/news/22/15888/karnataka-to-formulate-new-policy-on-st.html Tue, 03 Mar 2020 09:05:00 +0530 The 11th edition of Bengaluru India Nano, one of the front running events of the Department of IT, BT and S&T, Government of Karnataka with the theme ‘New Dimensions in Nanoscience and Nanotechnology for Industry 4.0’ was inaugurated by Chief Minister B S Yediyurappa in the presence of Prof. C N R Rao, FRS, National Research Professor, Linus Pauling Research Professor, Honorary President, Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), Chairman Vision Group on Science and Technology and Nanotechnology, Government of Karnataka and Chief Mentor of Bengaluru India Nano, Dr. C.N. Ashwath Narayan, Deputy Chief Minister and Minister for IT, BT and S&T, Higher Education, Skill Development, Entrepreneurship and Livelihood, Government of Karnataka, Prof. Roger Howe, Stanford University, USA, Rizwan Arshad, MLA, Shivajinagar, Dr. E V Ramana Reddy, IAS, Additional Chief Secretary, Department of IT, BT and S&T, Government of Karnataka and Chairman Karnataka Scientific and Technology Promotion Society (KSTePS), Prof. Ajay Sood, FRS, Chair Professor, Department of Physics, Indian Institute of Science, Bengaluru and Dr. H Honne Gowda, Special Secretary (Technical), Department of IT, BT and S&T, Government of Karnataka and Managing Director, Karnataka Science and Technology Promotion Society (KSTePS), on 2nd March 2020 in Bengaluru. Delivering the inaugural address, B S Yediyurappa, Hon. Chief Minister, Government of Karnataka, said, “Our aim is to make Karnataka a hub for nanotechnology. The Government of Karnataka is keen to provide the necessary priority through development of strong institutional base, infrastructure support and skilled manpower to create the right ecosystem for nanotechnology growth in the State. The Government is proposing to develop a nano park in the State in collaboration with the Government of India. Establishment of common instrumentation facilities to provide greater emphasis for growth of this emerging field will also be considered. Action will be taken for up-skilling and re-skilling the manpower required for this sunrise industry. I call upon scientists and engineers to come up with innovative nano technology based solutions for food security, energy security, water purification, healthcare, waste management and to combat environmental hazards, which are expected to increase many folds in the near future due to urbanization, population growth and change in lifestyle.” The Chief Minister also presented the prestigious Prof. C.N.R Rao Bengaluru INDIA NANO Science Award 2020 to Prof. P.S. Anil Kumar, Department of Physics, Indian Institute of Science, Bengaluru for his outstanding contribution to nanotechnology. Prof. C N R Rao, FRS, National Research Professor, Linus Pauling Research Professor, Honorary President, Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), Chairman Vision Group on Science and Technology and Nanotechnology, Government of Karnataka and Chief Mentor of Bengaluru India Nano said, “Nanotechnology has been making giant strides in the field of healthcare but I feel that there is still a lot of potential that can be tapped. I urge our young scientists to conduct more research in the field of healthcare and come out with some great solutions. Bengaluru India Nano acts as a global platform for convergence of research, academia and industry to explore emerging opportunities and for deliberation. Some of the key focus areas of Bengaluru India Nano 2020 will be on Nano in Energy for E-mobility, Nano in Agriculture, Nano for Clean Water and Environment and Nano in Manufacturing. Around 30 world class speakers from leading industries and organizations, both from India and abroad will address this event.” Bengaluru INDIA NANO is mentored by India’s foremost scientist Prof. C N R Rao, FRS, National Research Professor, Linus Pauling Research Professor, Honorary President, Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR) and Chairman Vision Group of Nanotechnology, Government of Karnataka and structured by the Vision Group on Nanotechnology, Government of Karnataka. Dr. C.N. Ashwath Narayan, Deputy Chief Minister and Minister for IT, BT and S&T, Higher Education, Skill Development, Entrepreneurship and Livelihood, Government of Karnataka, in his address said, “The Government of Karnataka is in the process of bringing out a Science and Technology Policy, wherein we are proposing many programs to support R&D in the State. The vision group chaired by Prof. CNR Rao will help us in formulating the policy and identify priority areas to build core competencies and foster research in this advanced discipline, so as to address present and future development needs. Our focus is also to make Bengaluru and Karnataka as a leader of Nanotechnology with collaboration and co-operation of premier institutes in Bengaluru such as Indian Institute of Science, Centre for Nano and Soft Matter Sciences, Jawaharlal Nehru Centre for Advanced Scientific Research, NCBS and others. The Government will leave no stone unturned to provide all facilities in terms of state-of-the-art infrastructure and proactive policy to ensure the growth of nanotechnology in the State.” In his speech, Dr. E V Ramana Reddy, IAS, Additional Chief Secretary, Department of IT, BT and S&T, Government of Karnataka, said, “The global market for Nanotechnology is projected to reach $125.70 billion by 2024 at a CAGR of around 17%, driven by growing R&D efforts directed at enabling the development of nanotech-based products and solutions in diverse industries. Bengaluru India Nano offers an unparalleled opportunity for business networking and for knowledge sharing in the exciting field of Nanotechnology and it has now evolved as the leading and most sought-after international Nanotech event in India.”  Among the prominent awards conferred at Bengaluru India Nano 2020 was Bengaluru India Nano Innovation Award which was presented to Dr. Sandip Patil, Founder Director, E-Spin Nanotech, Kanpur. ]]> https://biospectrumindia.com/news/22/15884/health-ministry-highlights-eradication-of-public-health-diseases.html https://biospectrumindia.com/news/22/15884/health-ministry-highlights-eradication-of-public-health-diseases.html Mon, 02 Mar 2020 09:35:00 +0530 “Under the dynamic leadership of our Prime Minister Narendra Modi, we are poised to achieve Universal Health Coverage by providing holistic care through the two pillars of Ayushman Bharat i.e. Pradhan Mantri Jan ArogyaYojana (PMJAY) to provide healthcare coverage to 50 cr citizens of the country and setting up of Health and Wellness Centres in all parts of the country. We aim to transform 150,000 PHCs and sub-centres to HWCs by 2022”, said Dr. Harsh Vardhan, Union Minister of Health and Family Welfare while inaugurating the 64th Annual National Conference of the Indian Public Health Association, at AIIMS New Delhi. Dr. Harsh Vardhan said that we have seen and experienced the major outbreaks across the globe like Nipah and Ebola which has struck so many countries but we didn’t allow such outbreaks in our country. Similarly, we have taken all the necessary precautionary measures to tackle the global scenario emerging due to Novel Coronavirus. He further said that we can also achieve the herculean target to eradicate Tuberculosis by 2025 with the contribution of all stakeholders way ahead to the timeline. Dr Harsh Vardhan stated that as the dynamics of diseases burden is changing worldwide, we need to look for newer solutions such as digital technology in health and geospatial information systems. He also said that India is now capable to create new milestones and show the way forward for Health for All. He added that with the wholehearted support of public health professionals, India was able to eliminate poliomyelitis and there are other success stories, where with the dedication and help of public health professionals, diseases of public health importance have been eradicated or eliminated from India. Because of such contributions of present and past members of the Indian Public Health Association (IPHA), the IPHA is held in high regard, he said. The Union Health Minister stated that with the theme of “Promoting Public Health Leadership for Universal Health Coverage in India”, this conference will see the convergence of India’s leading experts in the field of public health. The theme holds relevance in today’s India where “Ayushman Bharat” has been launched with a view to providing equitable health to its citizens, thereby achieving ‘Health for All’ goal. IPHACON 2020 will provide an opportunity to explore, learn and share knowledge on various health programms and initiatives by the government like Swastha Bharat Mission, Ayushman Bharat, PoshanAbhiyan and Jal Jeevan Mission for public health experts working in different fields. Eminent speakers from the field of public health will share their experiences, views and opinions on topics like public health leadership for UHC, Mission towards malnutrition free India, AnaemiaMukt Bharat, Tobacco Control, Strengthening public Health Systems, Anti- microbial resistance, Maternal Nutrition Programmes, Ending AIDS by 2030 and Updates on National Health Initiatives, Dr. Harsh Vardhan stated ]]> https://biospectrumindia.com/news/22/15844/govt-emphasises-on-immunisation-through-imi-2-0.html https://biospectrumindia.com/news/22/15844/govt-emphasises-on-immunisation-through-imi-2-0.html Tue, 25 Feb 2020 09:05:00 +0530 Dr. Harsh Vardhan, Union Minister of Health & Family Welfare inaugurated a special community outreach programme on Intensified Mission Indradhanush (IMI 2.0) at Shastri Park, Delhi, on 24 Feb, through a video message. The three-day event is being organised by Song & Drama Division of Bureau of Outreach & Communication (BOC), under Ministry of Information & Broadcasting. A video message of Dr Harsh Vardhan was shared with the participants in which he emphasised the importance of immunisation of children and pregnant women as part of the IMI 2.0 and the high priority being accorded by Government of India for achieving Full Immunisation Coverage (FIC) targets. He said that under the leadership of the Prime Minister, Narendra Modi, IMI was launched from Vadnagar in 2017 and immunization has been given a strong push in the Gram Swaraj Abhiyaan and Extended Gram Swaraj Abhiyaan. A more expansive version, IMI 2.0, is being carried out in 272districts across 27 States/UTs and 650 blocks of Bihar and Uttar Pradesh across 109 districts since December 2019, he added. "While we have targets to achieve 90% immunisation coverage target, we should all aim to ensure that not even one child is deprived of a vaccine against vaccine preventable diseases. Especially when we have a basket of vaccines as part of our routine Universal Immunisation Program (UIP)", Dr Harsh Vardhan said in his video message. “With the launch of Intensified Mission Indradhanush 2.0, India has the opportunity to achieve further reductions in deaths among children under five years of age, and achieve the Sustainable Development Goal of ending preventable child deaths by 2030”. Dr. Harsh Vardhan also added that currently we are providing vaccines against 12 vaccines preventable diseases, nationally against 10 diseases (Diphtheria, Pertussis, Tetanus, Polio, Measles, Rubella, severe form of Childhood Tuberculosis, Rotavirus diarrhea, Hepatitis B and Meningitis & Pneumonia caused by Hemophilus Influenza type Band) and sub-nationally against two diseases (Pneumococcal Pneumonia and Japanese Encephalitis); of which Pneumococcal Conjugate vaccine is in the process of expansion while JE vaccine is provided only in the endemic districts. The Union Health Minister stated the Government has made immunization a people's and a social movement. He made a strong appeal to all those present in the audience and the countrymen and women to own the programme in order to make all efforts to reduce maternal and child mortality. He also thanked the efforts put on by Bureau of Outreach & Communications who are relentlessly contributing through their Regional Outreach Bureaux (ROB) across the States/UTs in enhancing the awareness and informing people about the importance of Immunisation. He also elaborated that we can take lessons from our immense experience of the polio campaign where in addition to wholehearted efforts from the states, various non-state partners and stakeholders had joined hands to achieve set targets. "Let us learn from the best practices of the States, their experience of earlier rounds of Mission Indradhanush (MI) and share this knowledge for achieving last mile goals during IMI 2.0 rounds.” he emphasised. He also informed that coverage evaluation survey conducted in 190 IMI districts of the country shows an overall Full Immunization Coverage (FIC) increase by 18.5 percentage points (as compared to NFHS 4 data) in190 districts, whichis testimony of the highest level of political commitment. He further added that three rounds of IMI 2.0 have already been conducted from December 2019 and February 2020, wherein 29.74 lakh children and 5.90 lakh pregnant women have been vaccinated. One more round of IMI 2.0 is planned to be conducted in March 2020. ]]> https://biospectrumindia.com/news/22/15817/cabinet-approves-historic-bill-for-womens-welfare.html https://biospectrumindia.com/news/22/15817/cabinet-approves-historic-bill-for-womens-welfare.html Thu, 20 Feb 2020 11:50:00 +0530 The Union Cabinet, chaired by the Prime Minister, Narendra Modi has approved a historic Bill for the welfare of women in the country – the Assisted Reproductive Technology Regulation Bill 2020.  This follows the introduction in Parliament of the Surrogacy Regulation Bill 2020, and the approval of the Medical Termination of Pregnancy Amendment Bill 2020.  These legislative measures are path breaking steps to protect women’s reproductive rights.   Once the Bill is enacted by the Parliament, the Central Government shall notify the date of the commencement of the Act. Consequently, the National Board will be constituted. The National Board shall lay down code of conduct to be observed by persons working at clinics, to set the minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert manpower to be employed by clinics and banks. The States and Union Territories shall constitute the State Boards and State Authorities within three months of the notification by the Central Government. The State Board shall have the responsibility to follow the policies and plans laid by the National Board for clinics and Banks in the State.  The Bill also provides for National Registry and Registration Authority to maintain a Central database and assist the National Board in its functioning.  The Bill also proposes for a stringent punishment for those practising sex selection, sale of human embryos or gametes, running agencies/rackets/organisations for such unlawful practices.     The major benefit of the Act would be that it will regulate the Assisted Reproductive Technology services in the country.  Consequently, infertile couples will be more ensured/confident of the ethical practices in ARTs. ]]> https://biospectrumindia.com/news/22/15810/govt-backs-industry-for-innovating-drugs.html https://biospectrumindia.com/news/22/15810/govt-backs-industry-for-innovating-drugs.html Wed, 19 Feb 2020 10:30:00 +0530 At BioAsia 2020, the Asia’s largest Biotechnology and Life Sciences forum held from 17th to 19th Feb in Hyderabad, high profile deliberations and discussions took place on hot current topics of the global life sciences industry. The highlight of the event was CEO Conclave chaired by Piyush Goyal, Minister for Commerce and Industry, Government of India moderated by KT Rama Rao, Minister for Industries and Commerce, Government of Telangana.  The industry stalwarts and eminent panelists including Dr Vas Narasimhan, CEO, Novartis, Switzerland, Dilip Shanghvi, MD, Sun Pharma, Satish Reddy, Chairman, Dr Reddy’s Laboratories, Ajay Piramal, Chairman, Piramal Group and Jan Van Acker, President, Emerging Markets, Human Health, MSD Pharma discussed and deliberated on ‘Playing catch-up or preparing to lead?’ of the CEOs, by the CEOs’ in which they focused on being leader in generics, how can India leverage its strengths in generics, vaccines and tech industry to win the race further. They suggested as to where should India place its bet to compete against the likes of China, Israel etc., and what should be India’s long-term sustainability strategy in the evolving geopolitical and regulatory environment etc. Replying to a question being asked by KT Rama Rao, on ‘where does the minister see Indian pharma and biotech industry to grow at a time when India is aiming to become $ 5 Trillion economy by 2025, Piyush Goyal said that the Indian pharma and biotech industry is expected to grow to $100 billion from the current size of about $40 billion, growing at 10% CAGR, despite the recent Corona virus outbreak. He further said that the Government of India was looking at supporting the industry to redefining the future of pharma and biotech in the country to make it more thrive by enabling them to get the patent approvals granted in a record period of time worldwide.  Piyush Goyal also advocated that the price controls in India worked huge in favour of the people of the country and reiterated that price controls on drugs and medical devices would remain for the benefit of the society. During the discussion, KT Rama Rao highlighted the issues of price controls, withdrawal of incentives and delay and lack of coordination between the state and the central government agencies. Piyush Goyal assured the industry and the minister that he would conduct a meeting during the second week of March 2020 to address all the issues pertaining to the industry by meeting the leaders of the industry. ]]> https://biospectrumindia.com/news/22/15799/telangana-moves-from-blockbusters-to-niche-busters.html https://biospectrumindia.com/news/22/15799/telangana-moves-from-blockbusters-to-niche-busters.html Mon, 17 Feb 2020 19:30:00 +0530 Asia’s largest Life Sciences and Biotechnology convention – BioAsia 2020 kicked off on 17th February, in the presence of stalwarts from Life Sciences, Biotechnology, Pharma and Healthcare industries in India and abroad. The 17th edition of the three-day global forum, being held from 17th to 19th February at HICC, Hyderabad was inaugurated by KT Rama Rao, Hon’ble Minister for Industries and Commerce & IT, Government of Telangana. With the theme of ‘Today for Tomorrow’, the annual flagship event of Government of Telangana, BioAsia, is focusing on how innovations and technological disruptions are re-shaping the global life sciences sector. While inaugurating the summit, KT Ramarao said, "Hyderabad, with its surrounding districts, is India’s largest pharmaceuticals hub, which accounts for about one third of total country’s pharma production and exports. We are further committed to developing Hyderabad as one of the key global Research and Development (R&D) hubs and the results are clearly visible now as the city today serves over 1,000 global innovators in their vision to develop innovative and affordable pharmaceutical products. Various Indian and global companies including Sanofi, Novartis etc. have their significant footprint here and are constantly expanding their operations including R&D and digital support services. Within a span of 2 years, over 20 companies are expected to set up their manufacturing units and R&D centres in the Medical Devices Park”. During his speech, KT Rama Rao also stated that, while Syngene which has setup its first phase of R&D facility invested Rs 170 Crore,  Biological E, a Hyderabad based vaccine maker has also inaugurated its Rs 300 Crore facility with a potential of creating 1,000 new jobs in Genome Valley, as part of BioAsia. He also said that the Government of Telangana was looking at taking the Telangana’s combined enterprise value $50 billion to $100 billion and create 4,00,000 new jobs in the state. The state is also going to setup a B-Hub, biotechnology hub in the next 2 months and Curative Therapy Institute with the support of CCMB for cell gene research. Hon’ble Minister invited the industrialists to come and explore the opportunities that the state government of Telangana is creating for them at the new Pharma City, world’s largest pharma cluster which will be operational shortly as it has got almost all of the approvals it required from the government of India. During the event, a Memorandum of Understanding (MoU) has been signed by Dr Peter Piot, London School of Hygiene and Tropical Medicine and Jayesh Ranjan, IAS, Principal Secretary, Industries and Commerce & IT, Government of Telangana. ]]> https://biospectrumindia.com/news/22/15781/zero-tolerance-policy-to-realise-pms-vision-of-drug-free-india.html https://biospectrumindia.com/news/22/15781/zero-tolerance-policy-to-realise-pms-vision-of-drug-free-india.html Thu, 13 Feb 2020 16:45:00 +0530 The Union Minister for Home Affairs, Amit Shah inaugurated the two-day BIMSTEC (Bay of Bengal Initiative for Multi-Sectoral Technical and Economic Cooperation) 'Conference on Combating Drug Trafficking', in New Delhi on 13 Feb 2020. He congratulated the Narcotics Control Bureau (NCB) for organising this important conference and welcomed the delegations, coming from the Partner Nations including Bangladesh, Bhutan, Myanmar, Nepal, Sri Lanka, Thailand and different State Governments of India, in the conference. Home Minister also released the administrative and operational manuals of NCB on the occasion. Addressing the august gathering, Shah called illicit drug trade a global menace and said that it is a burning global issue that plagues every Nation, especially the Bay of Bengal littoral States. It is thus very important for all countries to engage with each other to exchange ideas, policies and best practices in order to combat this menace, he said. The Home Minister talked about Prime Minister, Narendra Modi's vision to end the global drug menace and recalled the 2018 Kathmandu BIMSTEC conference where PM invited the Partner Nations to India, while announcing the current conference on Combating Drug Trafficking. Shah quoted the PM and said that there is no nation in the world that is not affected by global terrorism, transnational crimes and illicit drug trafficking. He expressed confidence and hope that this conference would open new avenues and generate new solutions to combat the menace of drug trafficking in the region. The Home Minister assured the delegates that under Prime Minister Modi's vision of a Drug-free India, Government of India has devised a well laid out strategy to ensure inter agency coordination and revamp the prosecution mechanism to end the menace of drug trafficking. He stated that India would not allow illicit narcotics and psychotropic substances trade to happen within its boundaries. “We will not allow drugs from any country of the world to enter into our country nor will allow it to go out of the country”, he added. Talking about the zero tolerance policy followed by Government of India against narcotic drugs and psychotropic substances trade, Shah talked about various steps taken by India on national as well as international levels, including those at UN, INTERPOL, to combat this menace. The Home Minister said that India taking the lead in organising this BIMSTEC conference would act as the harbinger of new avenues within the region that will help bringing other Nations on such similar platforms to find solutions to tackle drug trafficking. He also termed the Bay of Bengal littoral States as the focus of India's ‘Neighbourhood First’ and ‘Act East’ policies and India being the largest country in the region will not shy away from its responsibilities in fighting drug trafficking and terrorism. Talking about the seriousness of the drug trafficking issue, Shah quoted the UN's World Drug Report and said that over 5% of the global population between 15-64 years of age is addicted to narcotics and use of illicit drugs. The Home Minister expressed concern that the rate of addiction is showing a fast increase i.e. a 30% rise in the last 10 years. He termed drug addiction as a curse for mankind as it not only kills the addict but also destroys families as well as the society, besides fuelling the evil of global terrorism and transnational crimes through its dirty money. Shah cited an estimate of over $ 400 billion of yearly illicit drug trade happening globally, giving an idea of the size of the mammoth issue facing humanity. The Home Minister laid emphasis on the need for all Nations to join hands and supplement each other's efforts in fighting this menace, as this global scourge cannot be fought by any country individually. He laid emphasis that Nations of the BIMSTEC are especially affected by illicit drug trade, transnational crimes and terrorism, making it all the more important to use platforms like this conference to devise coordinated strategies in ending the evil from its roots. Shah described how Indian security agencies have worked brilliantly to cease over 2 metric tonnes of illicit heroine till September 2019 as compared to 1.2 metric tonnes in 2018. He also said that Manipur and Mizoram having borders with Myanmar and other coastal States are sensitive and may become a gateway for illicit drugs entering India, which needs to be prevented. Talking about the steps taken by Government of India in combating the drug trafficking Shah said that the Union Government has laid down a well thought out strategy to increase coordination among the agencies of the Centre as well as States and the Home Ministry has established a joint coordination committee to increase surveillance over drug trafficking. The Ministry has also started an e-portal for digitalisation of drug data that may be utilized by various drug enforcement agencies. In the last 5 years, Over 1.89 lakh Narcotics cases have been registered in India, in which over 2.31 lakh drug smugglers have been arrested by the agencies including over 1500 foreign nationals, he said. The Home Minister also informed that the Ministry is about to establish a training centre for NCB officials regarding enforcement of drug laws, at Bhopal. To fight this global menace, India has so far signed 26 bilateral agreements, 15 MoUs and 2 security pacts with other countries. India has devised a strategy to increase awareness to dissuade the use of internet and social media in illicit drug trade. Further, Government of India has issued notification regarding the registration of B2B companies in order to prevent the online sale of narcotics and illicit drugs, he added. Concluding his address, Shah called upon the BIMSTEC Partner Nations to come together and work in a coordinated fashion to uproot the evils of illicit drug trade and global terrorism by establishing infrastructure for information sharing, training of drug enforcement officials, ensuring interoperability of law enforcement agencies to take coordinated action for devising new strategies to prevent the use of over 900 newly developed synthetic psychotropic substances that fall out of the international drug control regime net. He also said that there is a need for the scientific community to engage in research in making the pharmaceutical sector independent of the use of narcotic drugs and for this there is need to invest more in R&D sector. ]]> https://biospectrumindia.com/news/22/15722/ministry-of-health-releases-draft-of-drug-and-magic-remedies-bill-2020.html https://biospectrumindia.com/news/22/15722/ministry-of-health-releases-draft-of-drug-and-magic-remedies-bill-2020.html Wed, 05 Feb 2020 10:50:00 +0530 This Act, may be called the Drugs and Magic Remedies (Objectionable Advertisements) (Amendment) Act, 2020.  It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint.  In the Drugs and Magic Remedies (Objectionable Advertisements) Act, T954 (hereinafter referred to as the principal Act), in section 2, for clause (a), the following clause shall be substituted, namely:— (a) "advertisement" means any audio or visual publicity, representation, endorsement or pronouncement made by means of light, sound, smoke, gas, print, electronic media, internet or website and includes any notice, circular, label, wrapper, invoice, banner, poster or such other documents:  Provided that label or wrapper is an advertisement only if it contains any information or claim other than provided in the rules.". In the principal Act, in section 3, in the clause (d),— (a) in sub-clause (ii) at the end, the word "or" shall be inserted; (b) after sub-clause (ii) so amended the following sub-clause shall be inserted namely,— "(iii) after consultation with Ayurvedic, Siddha and Unani Drugs Technical Advisory Board constituted under section 33C of the Drugs and Cosmetics Act, 1940 in respect of Ayurvedic, Siddha and Unani system of medicines. " In the principal Act, for section 7, the following section shall be substituted, namely:— "7. Penalty.— Whoever contravenes any of the provisions of this Act [or the rules made thereunder] shall, on conviction, be punishable— a) in the case of first conviction, with imprisonment which may extend to two years and fine upto ten lakh rupees. b) in the case of a subsequent conviction, with imprisonment which may extend to five years and fine upto fifty lakh rupees.". In the principal Act, in the section 8 (2), for the words and figures "the Code of Criminal Procedure, 1898 (5 of 1898)", the following shall be substituted, namely:— "the Code of Criminal Procedure, 1973 (2 of 1974)" In the principal Act, in the section 9A, for the words and figures "the Code of Criminal Procedure, 1898 (5 of 1898)", the following shall be substituted, namely:— "the Code of Criminal Procedure, 1973 (2 of 1974)" In the principal Act, for the schedule, the following schedule shall be substituted, namely:— AIDS, angina pectoris, appendicitis, arteriosclerosis,  blindness, blood poisoning, bronchial asthma, cancer benign tumor, cataract, change in colour of hair and growth of new hair, change of foetal sex by drugs, congenital malformations, deafness, diabetes, diseases and disorders of the uterus, epileptic fits and psychiatric disorders, encephalitis, fairness of the skin, form and structure of the breast, gangrene, genetic disorders, glaucoma, goitre, hernia, high or low blood pressure, hydrocele, insanity, increase in brain capacity and improvement of memory, improvement in height of children or adults, improvement in size and shape of the sexual organ and in duration of sexual performance, improvement in the strength of the natural teeth, improvement in vision, jaundice or hepatitis or liver disorders, leukaemia, leucoderma, maintenance or improvement of the capacity of the human being for sexual pleasure, mental retardation, sub normalities and growth, myocardial infarction, obesity, paralysis, parkinsonism, piles and fistulae, power to rejuvenate, premature ageing, premature greying of hair, rheumatic heart diseases, heart disease, sexual impotence, premature ejaculation and spermatorrhoea, spondylitis, stammering, stones in gall-bladder, kidney, bladder, varicose vein, bright's disease, diseases and disorders of brain, disorders of menstrual flow, disorders of the prostatic gland, dropsy, female diseases (in general), hysteria, infantile paralysis, leprosy, lockjaw, locomotor ataxia, lupus, plague, pleurisy, pneumonia, rheumatism, ruptures, smallpox, sterility in women, trachoma, tuberculosis, typhoid fever, ulcers of the gastro-intestinal tract, venereal diseases, including syphilis, gonorrhoea, soft chancre, venereal granuloma and lympho granuloma, pyorrhea and sensitive teeth. ]]> https://biospectrumindia.com/news/22/15656/council-for-healthcare-and-pharma-recommends-increased-budget-allocations-de-bottlenecking-in-healthcare.html https://biospectrumindia.com/news/22/15656/council-for-healthcare-and-pharma-recommends-increased-budget-allocations-de-bottlenecking-in-healthcare.html Tue, 28 Jan 2020 10:10:00 +0530 The next Union budget is just around the corner. The Council for healthcare and Pharma (CHP) lauds the efforts of the Government and the vision of PM Narendra Modi in launching the visionary Ayushman Bharat and Jan Arogya programmes which aim to provide medical access and the right to health, to every citizen of India. These are gigantic steps in the right direction, with the plan being the largest ever conceived, in the world. It will particularly benefit the marginalised and those at the fringes of society. The last budget raised some of the allocations supporting the vision of healthcare for all and importantly brought the idea of a healthy India and its linked socio-economic benefits to prominence. However, given the ambitious task at hand allocations will have to be raised systematically and exponentially year on year, for the realisation of the dream. Additionally, they must be focused to solve the most pressing issues impeding progress. Dr Gurpreet Sandhu, President, CHP said, "We hope, the coming budget will address deficiencies while providing a strong impetus and necessary monetary allocations to capacity building. Qualified doctors, nurses and paramedics are in short supply and it is important to establish and resource medical colleges adequately, while drastically increasing seats for specialisation and super specialisation in medical institutions. On the input side, the pharmaceutical industry, medical devices, primary care facilities and hospitals all need scale, encouragement and supportive policies to meet the expectations and growing healthcare needs of the country." He added, "Preventive actions that encourage and keep people healthy must be promoted alongside health insurance that should cover both preventive and curative aspects including, diagnosis, periodic medical consults, preventive check-ups, traditional and allopathic medicines, hospital admissions, surgeries, medical implants and devices. Traditional medicine along with the availability of cutting-edge medicines and technologies must be encouraged and supported through benign policy and budgetary actions that encourage R&D efforts in the country." A framework with investment templates that encourage public private partnerships, build mutual trust and provide fair rewards for entrepreneurship, human endeavour and sustainable development of the sector is required. This could take the form of tax cuts, tax incentives, streamlined payments, lowered capex costs to attract creation and upgradation of supportive infrastructure and manufacturing facilities. Alongside IT, India had a head start in this sector and has served the globe well, reaching a level of maturity. While IT has continued to grow some parts in the health sector have experienced a lag. In a dynamic market India needs to remain globally competitive. This can be achieved if the country is known for quality, efficiency and cost structure. India therefore needs to have scale and significant market share, to be preferred global providers of modern healthcare, pharmaceuticals and adjunct services. India would do well to encourage these aspects in the forthcoming Union budget maintaining the course that it has embarked upon. The Council for Healthcare and Pharma (CHP) is an integrated, not-for-profit, Global think tank that advocates the development of sustainable health systems around the World. It looks at engaging with Governments and other stakeholders to adopt rational approaches that capture benefits, that accrue through the optimization of the eco-system and value chain involved in treating diseases and keeping people healthy. CHP members include global Pharmaceutical companies, Providers of Diagnostics, Medical device Manufacturers, Hospitals and adjunct services. The Council believes that in a world of volatility, uncertainty, complexity and ambiguity where the disease burden continues to grow, R&D, New Technologies and Pressures to enhance Quality and Access at a lower cost will drive the solutions. A mega integrated hub and spokes model that draws in all stakeholders and constituents will have to achieve sustainable and holistic health. CHP focuses on Africa, Brazil, China, Germany, India, Japan, UK and the USA. It's important areas of work are in ease-of-doing business; increasing competitiveness; broadening access to safe, efficacious and affordable healthcare services and medicines including generics and bio-similars. CHP is guided in its work by expert advisory committee's in Intellectual Property; Market Access; Regulatory Policy; Key Therapeutics - Women's Health, Oncology & Tropical Diseases; Research & Development (R&D); Artificial Intelligence (AI); Environment; Healthcare start-ups. As a significant and credible stakeholder in alleviating the burden of disease, the CHP brings to bear the collective wisdom of industry and policy makers on health issues that stand to make a positive contribution to society in bringing about Universal healthcare. ]]> https://biospectrumindia.com/news/22/15603/ficci-seeks-quick-notification-of-e-pharmacy-rules.html https://biospectrumindia.com/news/22/15603/ficci-seeks-quick-notification-of-e-pharmacy-rules.html Tue, 21 Jan 2020 15:00:00 +0530 Federation of Indian Chambers of Commerce & Industry (FICCI) has supported the industry to come up with a 'Code of Conduct' for e-Pharmacies in the country to ensure proper compliance and high standards of operation and ensure there is no compromise in patient safety. Currently, there are 50+ start-ups operating in e-Pharmacy space in the country, which provides quality and affordable medicines to about 50 lakh patients per month across the country and has served patients across 19000 + PIN codes.  About 30,000 skilled professionals are employed by the sector. e-Pharmacy sector has attracted Rs 4000 crore plus in FDI from some of the top global investors, and another Rs 2000 crore is expected in the next 2 to 3 years. According to FICCI, the delay in the notification of e-Pharmacy draft rules is causing confusion and anxiety for all the stakeholders involved in digital health ecosystem. Prashant Tandon, Chairperson,  FICCI e-Pharmacy Working Group, said, "e-Pharmacies abide by FICCI Code of conduct for e-Pharmacies, and comply with the laws of the land. All the orders for prescription-based medicines are processed only against a copy of valid prescription and are dispensed by a licensed pharmacy having a registered pharmacist. e-Pharmacies strictly do not accept orders for habit forming medicines, narcotics, or any other sensitive medicines. Additionally, given the importance of the e-Pharmacy sector globally, several large investors have recently reached out to the e-Pharmacy players, expressing concern about the general investment and regulatory climate in India and have asked for clarifications. Given the government's solid track record in making India 'Open for Business' we have been trying to allay their fears". FICCI is hopeful that the government would take into account the importance of digitization in healthcare space which eventually leads to an empowered consumer, and requests the government to notify the Draft e-Pharmacy Rules at the earliest. ]]> https://biospectrumindia.com/news/22/15542/cabinet-approves-moc-between-india-and-gates-foundation.html https://biospectrumindia.com/news/22/15542/cabinet-approves-moc-between-india-and-gates-foundation.html Tue, 14 Jan 2020 11:15:00 +0530 The Union Cabinet, chaired by the Prime Minister Shri Narendra Modi, has given its ex-post-facto approval on the Memorandum of Cooperation (MoC) between Department of Health & Family Welfare (DOHFW), Government of India and Bill & Melinda Gates Foundation (BMGF) on cooperation in the field of Health signed in November, 2019 during the visit of Mr. Bill Gates, Co-Chair and Trustee of BMGF to Delhi. The Memorandum of Cooperation (MoC) covers the following areas of cooperation:- a)     To reduce maternal, neonatal and child morbidity and mortality, improve key nutrition outcomes, by improving the reach, coverage and quality of essential primary health, immunization and nutrition services. b)     To increase the basket of choice and quality for family planning methods, specially for reversible methods, and increase access amongst younger women. c)     To reduce the burden of select infectious diseases [TB, Visceral Leishmaniasis (VL), Lymphatic Filariasis(LF)]. d)     To strengthen health systems, including aspects such as budget utilization, management and skills of human resources for health, digital health, strengthening supply chains and monitoring systems. A Program Action Committee (PAC) will be set up to further elaborate the details of cooperation and to oversee the implementation of this Memorandum of Cooperation. ]]> https://biospectrumindia.com/news/22/15541/national-policy-for-rare-diseases-2020-patient-groups-express-dejection.html https://biospectrumindia.com/news/22/15541/national-policy-for-rare-diseases-2020-patient-groups-express-dejection.html Tue, 14 Jan 2020 11:05:00 +0530 Government of India had formulated a National Policy for Treatment of Rare Diseases (NPTRD) in the year 2017. However, the Government decided to review the policy due to implementation challenges and in the light of new information and updates available/received for its further improvement and effective implementation. Policy 2020: Financial support up to Rs. 15 lakhs under the Umbrella Scheme of Rashtriya Arogaya Nidhi (RAN) shall be provided by the Central Government for treatment, of those rare diseases that require a one-time treatment State Governments can consider supporting patients of such rare diseases that can be managed with special diets or hormonal supplements or other relatively low-cost interventions The Government will endeavor to create alternate funding mechanism through setting up a digital platform for voluntary individual and corporate donors to contribute to the treatment cost of patients of rare diseases In response to this, patient groups are expressing their dejection on the draft National Policy for Rare Diseases 2020. "The policy is good in terms of thinking and long-term direction.  But it is far from reality and genuine interest in providing the much-needed treatment to the treatable Rare Diseases. There is no clarity, financial commitments, the group 3 Diseases where we were eagerly waiting, the plan is a mockery such as creating a digital platform for Crowd Funding. How can you design a policy based on donations by the government? The policy is just another piece of paper" - Prasanna Shirol, Founder of the Organization for Rare Disease India (ORDI). "This is not even draft policy document, it is like reading a document on Rare Diseases, more like a definition to layman - an illusion. Even the Draft makers could not comprehend in line. Most pages refer to definitions to rare Diseases, why so? A disease is a disease, why tag it with adjectives and phrases and nouns and pronouns. If there is definite cure, care to manage that. The best part of the document refers to add extensive diseases, which is appropriate and appreciable part texted by our experts Medical and Geneticists of India’s Prime Government medical institutions like AIIMS, Delhi, PGI Lucknow, PGI Chandigarh, KEM Mumbai and MAMC Delhi.  But sadly, the government has not and had no intentions to make this policy workable. Most of the diseases will not be covered in one-time solution of upto Rs. 15 lacs. or excuse of Crowd Funding and stressing the states to do their best. No patient of Lysosomal Storage Disorders (LSDs) will be eligible. The Ministry and Brooding ill-will political intention of people at helm aka bureaucratic delays and their hands bound, there doesn't seem to be any way forward. It's just an eye wash" - Manjit Singh, President, Lysosomal Storage Disorders Support Society. ]]> https://biospectrumindia.com/news/22/15514/icc-nathealth-ink-mou-for-new-healthcare-initiatives.html https://biospectrumindia.com/news/22/15514/icc-nathealth-ink-mou-for-new-healthcare-initiatives.html Thu, 09 Jan 2020 15:10:00 +0530 The Indian Chamber of Commerce (ICC) has signed a Memorandum of Understanding (MoU) with the apex healthcare industry body -Healthcare Federation of India (NATHEALTH). This will aim to explore and implement joint opportunities to co-develop Healthcare Initiatives in East, North-East and pan India. The partnership also aims to act as a joint platform for advocacy which is mutually cohesive. Speaking on the collaboration, Prashant Sharma, Chairman, ICC Healthcare Committee and MD Charnock Hospital, said, “This partnership would help the two bodies to push healthcare initiatives across the country with special focus on East and North East regions. Our main objective is to accelerate the development of the overall healthcare delivery system across society and to provide a sustainable ecosystem to all the stakeholders.” “With technology permeating through all verticals today, we are confident that we see advanced healthcare facilities that provide easily accessible and affordable services to the citizens of our country,” he added. The MoU was signed by Prashant Sharma on behalf of ICC and Siddhartha Bhattacharya, Secretary-General, NATHEALTH. Siddhartha Bhattacharya said, “NATHEALTH was created with the core mission of credibly unifying the voice of the healthcare ecosystem to co-create a better health care model for all Indians. We are very pleased to be working closely with the Indian Chamber of Commerce and forging an alliance to drive innovation and policy recommendations across healthcare financing, delivery and policy and regulatory spectrums towards providing better healthcare. The combined footprint of NATHEALTH and ICC unifies a large national collaborative effort across healthcare providers, medical equipment manufacturers, resellers, payers, value-added services providers, SMEs, innovators, hospitals, labs, diagnostics and technology providers which will create a strong knowledge and advocacy platform not only in Eastern Region but also at a national level.” Through this collaboration, NATHEALTH and ICC have identified five major areas of collaboration:   Policy Advocacy Initiatives: To act as a bridge and catalyst between all stakeholders in Healthcare domain and endure advocacy with respective regulators in State as well as in Central Government for directing future policy change through exchange of policy dialogues and participative consultations. Thought Leadership: To organize meetings, seminars, conferences and interactive sessions with experts, policymakers, industry captains to throw light and deliberate on critical issues affecting the industry and the economy at large. Knowledge Sharing: To publish Annual Report, White paper and Research paper on specific topics of relevance pertaining to Healthcare.  Support Members: To advise the members on matters affecting business and investment as related to various policies, regulation and legislation, etc. Capacity Building: To organize Jointly Events & Activities and other training programs regularly in keeping tune with the changing industry and technology.   ]]> https://biospectrumindia.com/news/22/15424/nathealth-recommends-gst-relief-for-healthcare-sector-.html https://biospectrumindia.com/news/22/15424/nathealth-recommends-gst-relief-for-healthcare-sector-.html Fri, 27 Dec 2019 10:00:00 +0530 As the government prepares to present its Union Budget 2020-21 on February 1, 2020, apex healthcare industry body NATHEALTH, in its pre-budget recommendations, called for building capacity in Tier-II & III cities which will cater to the growing demands of quality healthcare in rural areas as well. On taxation issues, the Apex Healthcare Industry body has recommended two options on Goods and Services Tax (GST). Firstly, NATHEALTH suggested a Zero-rating GST for healthcare services. "Rationalization of GST for healthcare input services would lead to the unlocking of the differential input credit and will ease costs for all healthcare providers including nursing homes, clinics, hospitals and diagnostic centres. This saving will be passed on to the end consumers and will lower the cost of care,” NATHEALTH said in a joint memorandum with FICCI. "Since GST is not payable on health care services, health care service providers are not eligible to avail credit on the input taxes paid by it, which ultimately becomes a cost for the service provider. Under the current GST regime, the net impact of revised tax rates on inputs (goods and services) consumed by hospitals has increased. As this incremental cost is ultimately borne by the patients, it defeats the intention of the Government to provide affordable healthcare services,” Dr Sudarshan Ballal, President, NATHEALTH said in the joint pre-budget memorandum. "The government needs to provide tax incentives for both existing and new projects. In our pre-budget recommendations also, we have strongly recommended that to spur investment in the sector, the Government could consider a tax holiday period of 15 years for hospitals. The length of the period of exemption needs to be longer, as new hospitals take at-least 5-7 years to start earning returns, after recovering interest and depreciation. For existing projects incentives can be given for 10 years, to support re-investment in capacity and technology upgrades,” he added. Underlining the importance of capacity building, Siddhartha Bhattacharya, Secretary-General, NATHEALTH said, “A priority sector status will act as a catalyst for channelizing funds for the sector from financing agencies. Higher investments would ensure quality infrastructure in Tier II & III cities and rural areas. Such a move would also ensure that the societal objectives of the Government are adequately met.” "The harmonized master list of infrastructure sub sectors by the Reserve Bank of India in 2012 includes Healthcare as a priority area for development. However, often these projects are long term based and require adequate funding options which are still not available at a Healthcare provider level. Thus long term funding options with clearly defined gestation period would certainly be a step in the right direction” he added. Following are the recommendations and suggestions that the apex healthcare body has put forth for the Government: Facilitating ease of access to capital, NATHEALTH recommends a dedicated fund for healthcare infrastructure and innovation not only for encouraging entrepreneurship with newer business models but also improve accessibility, availability and quality in Tier 2&3 cities including rural areas. Emphasizing on the problem of low penetration of health insurance being a major reason behind the rising out-of-pocket spending for healthcare services in India, NATHEALTH recommends the government should undertake additional efforts to make mandatory coverage for all citizens. NATHEALTH suggests that organized sector employees could be given the option of paying their ESI contribution or purchasing insurance from any IRDA regulated insurance company. Gradually, the focus can be then shifted to the middle and upper middle classes respectively in order to ensure access to preventive and curative care of sufficient quality and safeguards the entire community from financial distress. The industry rightly expects that the Union Budget 2020-21 will be announced keeping in focus the incentives for medical value tourism, Zero rating GST on healthcare services and health insurance premiums. Other areas which require efforts include incentivizing capacity building and promotional policies for private providers. These are long standing suggestions from the Industry and are critical to expedite investment in capacity building especially in Tier 2 & 3 cities for the realization of the dream of Universal Healthcare.   ]]> https://biospectrumindia.com/news/22/15380/govt-to-launch-ayush-export-promotion-and-research-council.html https://biospectrumindia.com/news/22/15380/govt-to-launch-ayush-export-promotion-and-research-council.html Fri, 20 Dec 2019 10:40:00 +0530 ‘2nd International Exhibition & Conference on AYUSH & Wellness sector - ‘International Arogya 2019’ organized by FICCI, jointly with Ministry of AYUSH, Department of Commerce, Ministry of Commerce & Industry, and Pharmexcil started on 19 December in Varanasi. Speaking at the conference, Vaidya Rajesh Kotecha, Secretary, Ministry of AYUSH, Government of India, said, “Government will soon launch AYUSH Export Promotion Council of India and AYUSH Export Research Council which will facilitate the exporting community and undertake promotional measures to increase exports.” “NABH & QCI have recently launched entry level standards of accreditation programme for practitioners and entrepreneurs who can start their day care facilities, hospitals around AYUSH with minimal standards to reach out to a wider audience across the country. We have received Rs 760 crore for providing soft loans and subsidies to entrepreneurs – contributing to the rapid growth of the AYUSH Sector”, he added. Dr Dharam Singh Saini, Minister of State (IC) AYUSH, Food Security & Drug Administration, Government of Uttar Pradesh highlighted the initiatives undertaken by the state government to promote various ancient Indian healing systems. Pramod Kumar Pathak, Additional Secretary, Ministry of AYUSH, Government of India, introduced the theme of the exhibition and conferences at the inauguration ceremony. Arvind Varchaswi, Co- Chair – FICCI AYUSH Committee & Managing Director- Sri Sri Tattva, while highlighting the importance of AYUSH system in our daily lives and the benefits of Ayurveda and yoga, said, “AYUSH is an integrative system of healthcare and wellness for the world and is time to use India’s 5000 year old wisdom on AYUSH to live a healthy life.” Anurag Sharma, Chair – FICCI AYUSH Committee & Member of Parliament, Government of India and Director-Shree Baidyanath Ayurved Bhawan Ltd., said, “Ayurveda has grown internationally. The need of the hour is for all of us is to try to make Ayurveda the system of medicine, recognized all around the world.” Prof Rakesh Bhatnagar, Vice-Chancellor, Banaras Hindu University, Varanasi, spoke about the expectations from International Arogya 2019. ‘FICCI – F&S Knowledge Paper on “Understanding the AYUSH Services Market in India’ was also released during the event. FICCI – F&S Knowledge Paper on “Understanding the AYUSH Services Market in India - Key takeaways of the report: India is known for its rich heritage couple with its own system of medicine such as Ayurveda and Yoga The Ayurveda Services Market is estimated at INR 7,700 Cr in 2018, and is anticipated to more than double by 2024, growing at a CAGR 13.1% The Domestic market is expected to grow at CAGR 10.2% during 2018–2024, while the Tourist segment is anticipated to grow at a CAGR 18.6% from 2018 to 2024. With active government push, the Ayurveda delivery ecosystem has spread over 33 states and union territories of India There were 443,704 registered Ayurvedic practitioners in India as on 1/1/2018, and has been increasing by 1.9% YoY from 1980 to 2018. There are 7,718 manufacturing units which are engaged in manufacturing of Ayurveda drugs as on 1/4/2018, of which 99.5% are privately owned Insurance coverage is increasingly being offered for Ayurveda hospitalization and medical care services. Ayurveda services are showing increasing uptake, primarily due to increasing awareness and the growing preference for natural therapies, but there are quite a few challenges that need to be overcome for sustained growth. An upswing in number of accreditations started only in 2018, and it is anticipated to witness a sharp increase during 2019-2024, especially with the NABH coming up with an ‘entry level’ NABH certification in May 2019.   ]]> https://biospectrumindia.com/news/22/15321/health-ministry-confers-uhc-awards.html https://biospectrumindia.com/news/22/15321/health-ministry-confers-uhc-awards.html Fri, 13 Dec 2019 10:50:00 +0530 Dr. Harsh Vardhan, Union Minister of Health and Family Welfare conferred the UHC Awards to best performing Primary Healthcare teams of States and UTs, in the presence of Ashwini Kumar Choubey, Minister of State for Health and Family Welfare, Preeti Sudan, Secretary (Health) and Dr. Indu Bhushan, CEO (NHA),  at the Universal Health Coverage (UHC) Day event organized by the Ministry of Health and Family Welfare, in New Delhi recently. To mark the UHC Day 2019, the Ministry organised three policy labs for extensive brainstorming  and deliberations on three themes: providing CHPC in urban areas; strengthening delivery systems; and communitisation for wellness.. Dr. Harsh Vardhan congratulated the award winners and appreciated their dedication and hard work towards expanding the universal health coverage through various parts of the country. Speaking at the event, he said that as we aspire to move speedily towards UHC, we must strengthen the preventive, promotive & positive health concepts. He also said some radical new changes and innovations need to be done to achieve health for all, and health in all. “Let us involve all Government  Ministries/Departments at the Centre and States, along with the non-state actors and organisations/institutions to engage them into the health agenda in a constructive, smart and intelligent manner”. Since health is a multi-sectoral, multi-dimensional, layered, and a complex sector, we need multiple partners for achieving the agenda of ‘Health For All’, he added. Ashwini Kumar Choubey stated that the commitment for ‘Health For all’ is clearly seen from the address of the Hon. Prime Minister Narandra Modi at the UNGA earlier this year where he highlighted four pillars for universal health care and gave the blueprint of how India plans to achieve the same. He added that people’s well being shall lead to global well being. Preeti Sudan, Secretary (Health) congratulated and thanked all the States & UTs for their efforts, which made possible the progress under HWCs and PMJAY. She stated that India has taken significant steps towards UHC by means of NHP 2017, Ayushman Bharat (with HWCs & PMJAY), the NMC Act, banning of e-cigarettes, approving 22 new AIIMS, up-gradation of 157 District Hospitals as Medical Colleges, etc. She further said that while the stage has been set for expanding UHC, we need to still address several challenges viz. expanding population, increasing & diversifying disease burden, devising different models for urban healthcare, accountability through social audits, engaging the private sector through effective partnerships etc. The three Policy Labs held today have helped us gain further clarity on the way forward, she added. Dr. Vinod Paul, Member, NITI Aayog applauded the progress made under Ayushman Bharat. He said it is as much a time to celebrate as to aggressively aspire for strengthening UHC models of effective delivery and also to push for the same. He stressed on the importance of health financing by the centre & states; infrastructure in terms of hospitals and number of beds/1000 population and building capacity of HR at all levels i.e. general practitioner to specialists to nurses and paramedical staff. Besides the awards, the event also saw the release of the CPHC Booklet for AB-HWCs, a Synthesis Report of Regional Workshops on AB-HWCs, Oral Healthcare Guidelines, AB-PMJAY 2020 Calendar and launch of the revamped AB-HWC portal. ]]> https://biospectrumindia.com/news/22/15254/india-sweden-unveil-healthcare-innovation-centre.html https://biospectrumindia.com/news/22/15254/india-sweden-unveil-healthcare-innovation-centre.html Tue, 03 Dec 2019 17:05:00 +0530 The Swedish Trade Commissioner’s Office in collaboration with the All India Institute of Medical Sciences, New Delhi (AIIMS, New Delhi) and All India Institute of Medical Sciences, Jodhpur (AIIMS, Jodhpur) announced the launch of India-Sweden Healthcare Innovation Centre in India at the India- Sweden Business Summit Inauguration held recently. The announcement was made in the presence of His Majesties King Carl XVI Gustaf of Sweden and in the presence of the Ministers Nirmala Sitharaman, Finance, Government of India and Ibrahim Baylan, Ministry of Enterprise and Innovation, Government of Sweden. The knowledge partner was represented by Mr. Leif Johansson, Chairman of the Board, AstraZeneca who reinforced the importance of innovation to achieve the ambition of providing affordable and accessible healthcare to all in the country. The signing of the Memorandum of Intent (MoI) took place at the event that marked the 10 years of India Sweden health cooperation in the presence of Dr. Harsh Vardhan, Union Minister of Health and Family Welfare and Dr. Maja Fjaestad, State Secretary, Ministry of Health and Social Affairs, Government of Sweden. AIIMS Delhi was represented by Dr. Randeep Guleria, Director and AIIMS Jodhpur by Dr. Sanjeev Misra, Director and Swedish Trade Commissioner’s Office by Anders Wickberg, Swedish Trade Commissioner to India. Chairman Leif Johansson, further commented, “AstraZeneca is honoured to partner with AIIMS and the Swedish Trade Commissioner’s Office to further innovation in healthcare. The centre will mainstream digital, scalable and affordable healthcare solutions for early diagnosis and digital intervention in the management of Non-Communicable Diseases (NCDs) such as diabetes and cancer, a shared challenge for India and Sweden.” Trade Commissioner Anders Wickberg, said, “This collaboration is built on the quadruple-helix model with the active participation of Government, academia, private enterprises and civil society. The broad vision of the collaboration is to strengthen the healthcare delivery system by an outcome and result based approach”. Director Dr. Randeep Guleria, commented, “AIIMS Delhi was created to serve as a nucleus for nurturing excellence in all aspects of healthcare. The institution continues to serve humanity by advancing knowledge, improving healthcare and saving lives. AIIMS Delhi is at the forefront of using innovation to improve therapeutics and translate science insights into new treatments. The India-Sweden Innovation Centre collaboration will further strengthen our efforts in finding innovative solutions for affordable and accessible healthcare in India.” Director Dr. Sanjeev Misra, commented, “AIIMS Jodhpur has been established with a mission to be a Centre of Excellence in medical education, training, research and patient care. The institution is committed to providing better services to patients by using innovation across all aspects. In line with Government of India’ ‘Digital India’ initiative, the institute went paperless and has organized multiple conferences where Innovation was a central theme. With AIIMS Jodhpur hosting important components of the India-Sweden Innovation Centre collaboration, the institution will contribute to create positive impact across the healthcare delivery system in the country.” The Centre is envisioned to develop an ecosystem of open innovation that healthcare delivery stakeholders can use to collaborate and address current and future challenges in the healthcare sector in India. It will enable development and scale up of solutions through frugal innovation for affordable and accessible healthcare in line with the objectives of the Government of India, including technology, data, protocols and processes, skill development and business models.   ]]> https://biospectrumindia.com/news/22/15230/health-ministry-puts-focus-on-technology-and-innovation.html https://biospectrumindia.com/news/22/15230/health-ministry-puts-focus-on-technology-and-innovation.html Fri, 29 Nov 2019 11:20:00 +0530 The 8thFoundation Day of Global Innovation and Technology Alliance (GITA) (PPP between Department of Science & Technology (DST) and Confederation of Indian Industry (CII)) was addressed by the Union Minister of Health & Family Welfare, Science & Technology and Earth Sciences, Dr. Harsh Vardhan, in New Delhi recently. The Minister recognized and felicitated the exceptional performance of GITA project in contributing towards enhancing the country’s innovation ecosystem. The theme of the event was ‘Making India Future Ready’. Dr. Harsh Vardhan said, “For India to grow at a sustained pace, technology and innovation have to become all-pervasive across all sectors of development.” and he also spoke about India’s aspiration to emerge as one of the top five knowledge powers in the world in the area of science, technology and innovation. The Minister congratulated GITA for successfully completing its 8thyear of operations and mentioned that GITA has managed to create a niche for itself as a catalyst for fostering innovation as well as generating awareness and interest of industry to enable them to benefit from the various Government schemes/funds being managed by GITA. Highlightingthe nation’s progress,Dr. Harsh Vardhan said that India is aggressively working towards establishing itself as a leader in industrialization and technological development and the Government has a strong focus on science and technology, realizing that it is a key driver of long-term economic growth.  Expressing confidence in the abilities of Indian scientists to rise up to the challenges and provide solutions to improve the lives of the common man, Dr. Harsh Vardhan said that creating a new eco-system of innovation and technology led entrepreneurship has become a national movement.  The Union Minister also launched the 2ndCall for Proposal for Joint Applied Research under the India-Korea Future Strategy Group. The India-Korea Future Strategy Group was created in July 2018 by the two Governments to expand and enhance cooperation in applied science and commercialization of industrial innovation for purposes of promoting sustainable development and enhancing the quality of life. The eligible sectors under this call are Future Manufacturing (smart factory, electric vehicle, 3D printing, robotics and automation, advanced material), Future Utilities (Renewable Energy (Renewable Energy including hydrogen and fuel cells)), energy efficiency, smart grid, Waste-to-Energy (WtE) technologies), digital transformation (information & communication technologies including  Big Data, software) and biotechnology/healthcare (affordable healthcare for the elderly and disabled; natural healthcare products).The Minister said that if India has to emerge as a true knowledge economy of the 21stcentury, it is inevitable that research and development leading to technology deployment has to be looked at as an in-house enterprise by all our leading industries including the SME sector as well. Hence, it is in the national interest of India to stimulate the private sector investments into R&D at levels of at least 1:1, in order to propel India as a leading scientific and technological power house.  Dr. Harsh Vardhan emphasized on ‘Start-up India’ initiative and said that the Government is extensively promoting Research Parks (RPs) and Technology Business Incubators (TBIs) which would promote the innovative ideas till they become commercial ventures. India is world’s largest technology start-up hub with more than 66,000 start-ups. India improved its rank on the Global Innovation Index for the fourth year consecutively. From being ranked at the 81stposition in 2015, India improved its ranking steadily to reach 52ndposition in 2019. GITA has been able to successfully engage in implementation of bilateral industrial R&D collaboration with some of the most innovative nations of the world including Canada, Finland, Israel, Italy, Korea, Spain, Sweden and the UK. The role of institutions such as GITA is increasingly relevant as we progress on the journey of creating India as an innovation nation in order to create a New India, which nurtures and cultivates a blossoming scientific temperament in the country. ]]> https://biospectrumindia.com/news/22/15191/niti-aayog-focuses-on-assistive-devices-industry.html https://biospectrumindia.com/news/22/15191/niti-aayog-focuses-on-assistive-devices-industry.html Mon, 25 Nov 2019 08:00:00 +0530 NITI Aayog has deliberated upon emerging opportunities in technological innovations, product development in assistive devices industry and policy interventions in the country.  The existing state of affairs pertaining to disability, assistive technology, allied industry and emerging opportunities in India was discussed. Broad areas of discussion included regulatory control and capacity building in the sector; incentivisation for the private players to invest in the industry; formulation of a concrete set-up involving the government, private industries, innovation centres like the IITs and the NGOs in order to transform the present reality; building and encouraging entrepreneurship; an economically viable model inclusive of affordability, adaptability, functionality and productivity; and strengthening indigenous R&D and promoting mass manufacturing of assistive devices technology in India.   Representatives from WHO, ICRC, World Bank, CII, PHDCC, ASSOCHAM, ALIMCO, Microsoft, IIT and others actively participated in the discussion and threw light on aspects pertaining to the empowerment of the disabled via creation of suitable and sustainable opportunities coupled with assurance of better regulatory framework centred on affordability and accessibility.  The meeting emphasized and concurred upon the much needed ice-breaker in the form of a conference on assistive devices industry, which will be the launchpad for future collaborations in the sector of assistive technology in India. ]]> https://biospectrumindia.com/news/22/15178/medical-technologies-form-critical-pillar-of-healthcare.html https://biospectrumindia.com/news/22/15178/medical-technologies-form-critical-pillar-of-healthcare.html Fri, 22 Nov 2019 06:00:00 +0530 “The discussions and knowledge sharing from this world conference need to be utilized for larger public welfare. We must optimally develop a robust system of sharing knowledge & other resources to practically translate discussions from this platform into action” said Dr. Harsh Vardhan, Union Minister for Health & Family Welfare as he inaugurated the ‘2019 World Conference on Access to Medical Products Achieving the SDGs 2030’ on 19th November in New Delhi. Calling the Conference a valuable platform for sharing experiences and advancing increased access to medical products globally as part of Universal Health Coverage (UHC), the Union Health Minister stated “ThisnConference will spur innovative thinking around issues surrounding provisioning of affordable, quality medical products as part of public health care delivery systems.” He added that medical technologies underpinned by latest ideas and pooled-in knowledge, form a critical pillar of healthcare. The inaugural session saw the release of ‘Position Paper-2019 World Conference on Access to Medical Products–Achieving the SDGs 2030’, ‘White Paper on Safety of Rotavirus Vaccine in India: Smart Safety Surveillance Approach’ and the ‘National Guidelines for Gene Therapy Product Development and Clinical Trials’. Following the UN High-Level Meeting (UN HLM) on UHC, the 2019 World Conference seeked to take forward the international and national agenda on access to medical products. The Conference was a follow on from the “2017 and 2018 World Conference on Access to Medical Products” organized in November 2017 and October 2018 by the Ministry of Health and Family Welfare, Government of India. The recommendations made at the two previous World Conferences are being pursued at international and national level by key ministries in India. This 2019 Conference provided a platform for discussions focused on creating an enabling legal and trade environment for public health which are critical to achieving the Sustainable Development Goals 2030 Agenda. The main objective of the 2019 World Conference was to track the progress on recommendations from the 2018 World Conference for access to medical products for achieving UHC in the context of SDGs. This 3-day Conference had been designed as a forum to take these discussions further for access to medical products on the themes of ‘UHC and innovation’, ‘Regulation of medical products and access’ and ‘Legal landscape and trade-related aspects in the context of access to medical products’. On the final day of the conference on 21 November, Dr. Henk Bekedam, WHO Representative to India, called India the pharmacy of the world, not just for vaccines and generic drugs but now also for medical devices. “I appreciate the regulatory framework that is followed in India and I applaud the fact that now India has launched the biggest hepatitis B program in the under-developed world”. Dr. Bekedam also highlighted how the Ayushman Bharat – Pradhan Mantri Jan Arogya Yojna (AB-PMJAY) is reducing the out of pocket expenditure of the people and providing cashless tertiary care. ]]> https://biospectrumindia.com/news/22/15145/health-ministry-inks-moc-with-bill-melinda-gates-foundation.html https://biospectrumindia.com/news/22/15145/health-ministry-inks-moc-with-bill-melinda-gates-foundation.html Wed, 20 Nov 2019 06:05:00 +0530 Bill Gates, Co-Chair, Bill & Melinda Gates Foundation (BMGF) called on Dr. Harsh Vardhan, Union Minister for Health and Family Welfare, in New Delhi.  They presided over the signing of a Memorandum of Cooperation (MoC) between the Health Ministry and the Gates Foundation. The MoC was signed by Lav Agarwal, Joint Secretary (International Health) from MoHFW and M. Hari Menon, Director, India Country Office, BMGF. At the meeting, Dr Harsh Vardhan highlighted the strides being taken in providing UHC to its citizens and the contribution of Ayushman Bharat with its pillars of HWCs and PMJAY; noteworthy gains in reduction of maternal and child mortality; expanding the coverage of full immunisation; and achievements in sectors such as TB; ambitious steps in digital health through the National Digital Blueprint framework. “Our visionary Prime Minister, Narendra Modi has a vision of creating a New India by 2022, where everyone is assured of universal health coverage. Our efforts and initiatives are focussed in this direction”, he stated. Commenting on the MoC, Dr. Harsh Vardhan said, “Our association with Gates Foundation has been a long and fruitful one, be it for Polio eradication or increasing immunization coverage. However, now is the time to work together for providing Universal Health Coverage (UHC) to all our countrymen with an effective and quality-driven primary healthcare system. We recognize the importance of adopting innovative approaches that will not only address the gaps in the system but also build on all that we have achieved so far.” He emphasized that the MoC with the Gates Foundation will be mutually beneficial, and we look forward to working with the Gates Foundation and leveraging their expertise in supporting MoHFW’s efforts towards strengthening its health systems. Supporting the initiatives undertaken by the Health Ministry, Bill Gates said, “The Ministry of Health has put forward an ambitious vision to improve the primary healthcare system in this country – especially for women and children. Our Foundation supports that goal, and we want to partner with India to achieve it. That’s why we are very happy to sign this Memorandum of Cooperation today.” Under the MoC, Gates Foundation will provide technical, management and program design support through its grantees and other partners, with a special focus on innovation, best practices and enhancing performance management, while working closely with the government. The Foundation will support the Ministry’s work towards strengthening the primary health aspects such as reducing maternal and child mortality, improving nutrition services and increasing the immunization reach. Efforts will be made to increase access to family planning measures amongst younger women and reduce the burden of select infectious diseases (Tuberculosis, Visceral Leishmaniasis, Lymphatic Filariasis). The work will also include strengthening of supply chains and monitoring systems while focusing on budget utilization, management and skills of human resources for health, ultimately bolstering the entire health system. ]]> https://biospectrumindia.com/news/22/15140/niti-aayog-releases-report-on-building-a-21st-century-health-system-for-india.html https://biospectrumindia.com/news/22/15140/niti-aayog-releases-report-on-building-a-21st-century-health-system-for-india.html Mon, 18 Nov 2019 15:05:00 +0530 NITI Aayog has released the report on ‘Health Systems for a New India: Building Blocks—Potential Pathways to Reforms’. The report was released by NITI Aayog Vice Chairman Dr Rajiv Kumar in the presence of Bill Gates, co-chairman of Bill and Melinda Gates Foundation, officials from NITI Aayog, policymakers, and representatives from national and international academia and Bill and Melinda Gates Foundation were also present for the event. Over the last few years, India has embarked on a journey towards providing improved access to high-quality, affordable healthcare for the most unreached and vulnerable population of the country. Many indicators, however, continue to show significant scope for improvement. By placing health at the centre-stage of the policy narrative, this report charts a clear roadmap for the complete transformation of India’s health system. It focuses on breaking silos in the health space and removing fragmentation between various initiatives, ensuring greater convergence between ministries as well as the Centre and states, as already initiated under Ayushman Bharat. Dr Rajiv Kumar said, “At a systems level, overcoming the challenges of fragmentation, across healthcare financing and service delivery, will help us optimize both quality and access. India now needs to build on its many opportunities to achieve further progress on the health of its citizens and respond to the growing aspirations and needs of a new India.” Lauding the significant improvements made in India's health sector, Bill Gates said primary healthcare is extremely important for all. He said, “India is in a very hopeful situation and is set to be an example for other countries. The private sector needs to be involved to meet key challenges and that the Gates Foundation through its initiatives will extend all possible help. The report identified 5 focus areas of future health system, deliver on unfinished Public health agenda, change health financing away from out of pocket so spend into large insurers, integrate service delivery vertically and horizontally, empower citizens to become better buyers of health, harness the power of digital health. Highlighting the need to build India’s opportunities, the vision for health over the next fifteen years is to transform the delivery of health services in a way that they improve at a much greater pace, without financially burdening its citizens. A synthesis of all the discussions and efforts initiated at NITI Aayog’s ‘Development Dialogues’ held on 30 November 2018, the report consolidates global findings on key health system themes of financing and provisioning, with a focus on risk pooling, strategic purchasing, health-service provisioning and digital health. With insights to transform the Indian health system in the twenty-first century, the report presents a preliminary menu of strategic choices available before India to reform its healthcare system. This report was guided by analysis undertaken by well-known international experts, along with other national counterparts representing the government, private sector, insurance companies, researchers and academia. The analysis and insights highlight that investments in strengthening the current health system will reap tremendous social and economic dividend for India.     ]]> https://biospectrumindia.com/news/22/15141/india-seeks-to-build-21st-century-health-system.html https://biospectrumindia.com/news/22/15141/india-seeks-to-build-21st-century-health-system.html Mon, 18 Nov 2019 15:05:00 +0530 NITI Aayog, a policy think tank of the Government of India has released the report on ‘Health Systems for a New India: Building Blocks—Potential Pathways to Reforms’. The report was released by NITI Aayog Vice Chairman Dr Rajiv Kumar in the presence of Bill Gates. Officials from NITI Aayog, policymakers, and representatives from national and international academia and Bill and Melinda Gates Foundation were also present for the event. Over the last few years, India has embarked on a journey towards providing improved access to high-quality, affordable healthcare for the most unreached and vulnerable population of the country. Many indicators, however, continue to show significant scope for improvement. By placing health at the centre-stage of the policy narrative, this report charts a clear roadmap for the complete transformation of India’s health system. It focuses on breaking silos in the health space and removing fragmentation between various initiatives, ensuring greater convergence between ministries as well as the Centre and states, as already initiated under Ayushman Bharat. ‘At a systems level, overcoming the challenges of fragmentation, across healthcare financing and service delivery, will help us optimize both quality and access. India now needs to build on its many opportunities to achieve further progress on the health of its citizens and respond to the growing aspirations and needs of a new India,’ said Dr Rajiv Kumar, Vice Chairman, NITI Aayog. Lauding the significant improvements made in India's health sector, Bill Gates, co-chairman of Bill and Melinda Gates Foundation, said primary healthcare is extremely important for all. India is in a very hopeful situation, he said, and is set to be an example for other countries. He mentioned that the private sector needs to be involved to meet key challenges and that the Gates Foundation through its initiatives will extend all possible help. The report identified 5 focus areas of future health system, deliver on unfinished Public health agenda, change health financing away from out of pocket so spend into large insurers, integrate service delivery vertically and horizontally, empower citizens to become better buyers of health, harness the power of digital health. Highlighting the need to build India’s opportunities, the vision for health over the next fifteen years is to transform the delivery of health services in a way that they improve at a much greater pace, without financially burdening its citizens. A synthesis of all the discussions and efforts initiated at NITI Aayog’s ‘Development Dialogues’ held on 30 November 2018, the report consolidates global findings on key health system themes of financing and provisioning, with a focus on risk pooling, strategic purchasing, health-service provisioning and digital health. With insights to transform the Indian health system in the twenty-first century, the report presents a preliminary menu of strategic choices available before India to reform its healthcare system. This report was guided by analysis undertaken by well-known international experts, along with other national counterparts representing the government, private sector, insurance companies, researchers and academia. The analysis and insights highlight that investments in strengthening the current health system will reap tremendous social and economic dividend for India. ]]> https://biospectrumindia.com/news/22/15134/mohfw-endeavors-to-foster-cross-learning.html https://biospectrumindia.com/news/22/15134/mohfw-endeavors-to-foster-cross-learning.html Mon, 18 Nov 2019 06:45:00 +0530 “This NHM National Summit is a celebration of ideas, innovations and knowledge sharing and we all must take back these and ensure that we implement at-least a few of them” said Dr Harsh Vardhan, Union Minister for Health & Family Welfare as he inaugurated the Sixth National Summit on Good, Replicable Practices and Innovations along with Union Minister of State for Health & Family Welfare Ashwini Kumar Choubey,  Vijay Rupani, Chief Minister, Gujarat,  Nitinbhai Ratilal Patel, Dy. CM & Minister of Health & Family Welfare, Gujarat and Dr Vinod K Paul, Member (Health), NITI AAYOG at Gandhinagar (Gujarat). Calling the Summit as the aggregating ground of new ideas, thoughts and expression, the Union Health Minister stated “MoHFW endeavors to foster cross learning amongst the State Governments, NGOs, Healthcare organizations and other academic institutions so that these work in concordance to achieve the overarching public health goals.” Dr Harsh Vardhan suggested that similar to the National NHM Summit, the States also can have State/Regional conferences for sharing of knowledge within the districts. “Let the national knowledge and ideas be transmitted to the districts level health workers, functionaries through the state/regional conferences”. He added that in addition to presenting best practices, states must also emulate and roll out the best practices from other states. He stressed the importance of self-auditing for performance assessment. Dr Harsh Vardhan also highlighted the noteworthy achievements in the health sector during the past few years such as Ayushman Bharat, Telemedicine, NHP 2017, Medical Education, and Health Systems Strengthening. Ashwini Kumar Choubey, Minister of State for Health & Family Welfare appreciated the efforts made by the Centre and States to reach out to the beneficiaries and provide access to quality healthcare services. He said that “The Summit provides a valuable platform for sharing of knowledge and experiences. This will immensely contribute to meeting our health outcomes”. He also highlighted the initiatives taken for providing preventive, promotive, affordable and quality healthcare services including AYUSH services. Dr Vinod K Paul, Member (Health), NITI AAYOG addressing the summit emphasized the importance of system level change for greater strides in healthcare and termed NHM as great program for healthcare delivery to the populace. He said ”There are seven building blocks for the future advances in the health sector- focused stewardship, adequate finance, capable HR, health commodities, service delivery which is equity & quality driven, information systems, and community participation for social and behavior change.” The Summit saw the launch of SAANS campaign i.e. “Social Awareness and Action to Neutralise Pneumonia Successfully” to control Pneumonia. This campaign will mobilize people's for protecting and preventing children from pneumonia; and health personnel, governments & other stakeholders to prioritize treatment towards the control of Pneumonia — one of the most fatal childhood illnesses. Under the SAANS campaign, new interventions have been included like a child suffering from Pneumonia will be treated with pre-referral dose of Amoxicillin by ASHA; Pulse Oximeter will be used at the Health and Wellness Centre for identification of low oxygen levels in the blood and if required treated by use of Oxygen. The initiative also aims to create mass awareness about the most effective solutions for pneumonia prevention like breast feeding, age appropriate complementary feeding, immunization, good quality air etc. The web portal for home based care of children including newborn visited by ASHA, was also launched at the Summit. This portal has all the resource materials (training materials, IEC videos, audios, banners, posters etc.) for the home visits of ASHAs. The portal will also be used to monitor the progress of programs regarding home visits by ASHAs and referral of sick newborns, an intervention considered globally as game changer to improve child survival and also improve nutritional status and overall development of children. The dignitaries also unveiled the Coffee Table Book documenting the Good and Replicable Practices presented during the Summit. Dr Harsh Vardhan along with other dignitaries acknowledged the exemplary progress of States and Union Territories in key health indicators and programme areas by presenting them with awards for excellent performance. The Ministry of Health & Family Welfare, GoI holds National Summit on Good, Replicable Practices and Innovations in Public Healthcare Systems in India annually to recognize, showcase and document various best practices and innovations adopted by States and UTs for addressing their public health challenges and to improving their health outcomes though better implementation of programmes under National Health Mission (NHM). More than 300 participants attended the summit. At the summit 37 good practices were presented and 73 emerging good practices were showcased in the form of poster presentations. ]]> https://biospectrumindia.com/news/22/15123/nha-collaborates-with-aitwa.html https://biospectrumindia.com/news/22/15123/nha-collaborates-with-aitwa.html Fri, 15 Nov 2019 11:10:00 +0530 National Health Authority (NHA) and All India Transporters Welfare Association (AITWA)  announced a partnership by signing an MOU aimed at providing the healthcare services to 10 million truck drivers in India under ‘Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana’ (PM-JAY) scheme. Implemented by the National Health Authority, PM-JAY, is India’s flagship public health insurance/assurance scheme, which is also world’s largest publicly funded health insurance/assurance scheme.   A tripartite MoU has been signed in presence of Dr. Indu Bhushan, CEO, NHA by Rohit Deo Jha, General Manager, NHA and Mahendra Arya, President, AITWA and representative from Common Service Centres (CSC), Ministry of Electronics and Information Technology, Government of India. Also present at the occasion were Pradeep Singhal, Chairman AITWA and SN Arya, Patron AITWA. Under this partnership, NHA and AITWA will work together to identify truck drivers & employees at transport companies eligible for the scheme. CSC will facilitate the verification of drivers using NHA’s Beneficiary Identification System (BIS). Through this collaboration, thousands of eligible families will be able to access in-patient care for serious illnesses at a country-wide network of 19,002 government and private hospitals empanelled under PM-JAY.  Drivers can get their AB PM-JAY e-cards issued at the nearest AITWA Highway Hero Center. The first phase will see AITWA and AB PM-JAY conduct pilot at key locations which will subsequently be rolled out to other towns across the country. Eligible drivers as well as employees, across different transport companies, will be able to avail the benefits of the programme and after obtaining the PM-JAY cards. Officials from the National Health Authority will work closely with the concerned team at AITWA and CSC for conducting beneficiary identification drive. Sharing his views, Mahendra Arya highlighted that their partnership with the National Health Authority is a step forward in enabling quality healthcare to transport industry workers and their families. The effort to enroll eligible beneficiaries under PM-JAY from the transport industry will truly strengthen the Highway Heroes project, focused on welfare of transport workers. Dr. Indu Bhushan said, “The partnership with AITWA is another milestone in our endeavour to reach the maximum beneficiaries across the country. This collaboration with AITWA will enable us to further expand our network to provide quality inpatient care, and we look forward to effectively driving awareness about Ayushman Bharat PM-JAY among potential beneficiaries.” Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) provides a cover of up to Rs. 5 lakhs per family per year, for secondary and tertiary care hospitalization to over 10.74 crore vulnerable entitled families (approximately 50 crore beneficiaries). PM-JAY provides cashless and paperless access to services for the beneficiary at the point of service. Under this scheme there are 1,393 health benefit packages with defined rates. Over 19,000 hospitals and health care providers have been empanelled across the country to provide healthcare services as per these packages. ]]> https://biospectrumindia.com/news/22/15099/karnataka-govt-to-strengthen-academic-and-healthcare-sectors.html https://biospectrumindia.com/news/22/15099/karnataka-govt-to-strengthen-academic-and-healthcare-sectors.html Tue, 12 Nov 2019 15:35:00 +0530 Bengaluru Tech Summit 2019 (BTS), being organised by the Dept. of IT & BT, Government of Karnataka (GoK) with the theme Innovation and Impact 2.0, will be opening at Bengaluru Palace on 18th November, till 20th November at the Bengaluru Palace. At the curtain raiser of the event held in Bengaluru, Dr C N Ashwath Narayan, Deputy Chief Minister, and Minister for IT, BT and S&T, GoK,  highlighted, "The industry is doing a tremendous job in the IT and BT sector. But the academic sector is lagging behind and it requires to be strengthened. The Karanataka Govt is working in this direction and will soon develop a system where all the challenges facing the education and academic sector can be addressed. At the same time, the government will also strengthen the healthcare sector. A lot needs to be done in this regard." The minister also announced the launch of an upcoming IT policy in 2019. Talking about the major highlights of the upcoming BTS 2019 event, he said, "At BTS we will be announcing specific regulatory measures to enhance innovation in Bengaluru and the rest of the state. We are currently in the process of engaging with various stakeholders to design the regulatory relaxations. In addition, at BTS, the govt will also announce a mechanism for startups to interact with the govt and the industry for proactive decision making." The summit is expected to see the particpation of 20 countries with over 250 speakers, providing a platform for discussion and deliberation to encourage disruptive technologies in the form of four major track sessions: Smart IT, Smart Bio, Global Innovation Alliances (GIA) and Impact.  The conference at the summit focuses on a multitude of frontier technologies ranging from Blockchain, AI, ML & Robotics, Intelligent Apps and Analytics, Immersive Experience (AR/VR), IOT, Telecom, Cyber Security, BioPharma, BioAgri, BioIT, BioIndustrial and BioServices. ]]> https://biospectrumindia.com/news/22/15084/india-on-track-to-achieve-mmr-targets-for-sdg.html https://biospectrumindia.com/news/22/15084/india-on-track-to-achieve-mmr-targets-for-sdg.html Mon, 11 Nov 2019 11:10:00 +0530 “Maternal Mortality Ratio (MMR) of India has declined by 8 points in one year as per the latest Special Bulletin on MMR released by the Registrar General of India. This decline is important as it translates to nearly 2000 additional pregnant women saved annually”. This was stated by Dr. Harsh Vardhan, Union Minister of Health & Family Welfare. The Union Health Minister further added that the MMR has declined from 130/ lakh live births in 2014-16 to 122/ lakh live births in 2015-17 (6.2% decline). “With this persistent decline, India is on track to achieving the Sustainable Development Goal (SDG) target for reducing MMR by 2025, five years ahead of timeline of 2030”, he underlined. Dr. Harsh Vardhan also congratulated the 11 States who have achieved the ambitious target of MMR of 100/lakh Live Births by 2020 set under the National Health Policy 2017. These states are Kerala, Maharashtra, Tamil Nadu, Andhra Pradesh, Jharkhand, Telangana, Gujarat, Uttarakhand, West Bengal, Karnataka and Haryana. The most important feature of this bulletin is that MMR for the States of Jharkhand, Bihar, Chhattisgarh, Madhya Pradesh, Uttar Pradesh and Uttarakhand have been published independently for the first time. A total of seven States, namely Karnataka, Maharashtra, Kerala, West Bengal, Odisha, Rajasthan, Telangana have shown a decline in MMR that is greater than or equal to the national average of 6.2%. Further highlighting the driving factors for the significant and laudable achievements, Dr Harsh Vardhan stated that this has been possible in view of the gains made in institutional deliveries and focused approach towards High Priority Districts and inter-sectoral action to reach the most marginalized and vulnerable population. Focus on quality and coverage of health services through public health initiatives under the National Health Mission such as Pradhan Mantri Surakshit Matritva Abhiyan, Janani Shishu Suraksha Karyakram and Janani Suraksha Yojana have contributed to this decline, he stated. India is on track to achieve SDG target of MMR, however the four states namely Assam, Uttar Pradesh, Madhya Pradesh and Rajasthan will have to intensify their efforts to accelerate the MMR decline to achieve the SDG target. New initiatives in the form of LaQshya, POSHAN Abhiyan and SUMAN (Surakshit Matritva Aashwasan Initiative) will help to ensure that all pregnant women receive quality maternal care with dignity and that no mother or newborn dies due to a preventable cause. ]]> https://biospectrumindia.com/news/22/15066/cabinet-approves-healthcare-mous-with-brazil-and-germany.html https://biospectrumindia.com/news/22/15066/cabinet-approves-healthcare-mous-with-brazil-and-germany.html Thu, 07 Nov 2019 11:05:00 +0530 The Union Cabinet chaired by the Prime Minister Narendra Modi has given ex-post facto approval for the MoUs between India and Germany for collaboration in the field of Occupational Diseases, Re-habilitation and vocational training of Insured Persons with disabilities; and for the MoU between India and Brazil in the field of Health and Medicine. The MoUs with the DGUV, a specialized agency in Germany working for Occupational Safety and Health (OSH) and social protection, will help broadly in:- Exchanging information and promoting activities in the area of rehabilitation related to medical, occupational and social re-habilitation of Insured Persons with disabilities, and Prevention, detection and treatment of occupational diseases. Exchange of information and collaboration will enable capacity building and social re-habilitation of Insured Persons with disabilities, besides prevention, detection and treatment of occupational diseases.   The bilateral MoU between India and Brazil will encourage cooperation between the two countries through joint initiatives, technology development in the health sector and development of research in the health sector. It will facilitate in improving the public health status of people of both the countries. It will strengthen bilateral ties between India and Brazil. ]]> https://biospectrumindia.com/news/22/15057/govt-puts-focus-on-leveraging-more-on-st.html https://biospectrumindia.com/news/22/15057/govt-puts-focus-on-leveraging-more-on-st.html Wed, 06 Nov 2019 11:45:00 +0530 The Union Minister for Science and Technology, Earth Sciences and Health and Family Welfare, Dr. Harsh Vardhan has said that India shares a common past and goal with many of its close neighbours and other partner countries that has served to forge an unbreakable association with India. Addressing delegates from various countries in Kolkata during the Overseas Ministers and Diplomats Conclave as part of the India International Science Festival (IISF), Dr. Harsh Vardhan emphasised on the need to harness the soft prowess of science and technology as an important pillar of the cooperation in the knowledge economy of the 21st century. He said that the present government led by the Prime Minister Narendra Modi strongly believes that science and technology is the bedrock upon which the country relies for its knowledge power, enterprises rely for their success, and the people rely for a better life. This government is therefore fully committed to promote science with a human face that serves the common man and promotes equitable and sustainable development of the country, he said. Dr. Harsh Vardhan said that need of the hour is to leverage more on science and technology to bridge disparities between urban and rural sections with focus on affordable technologies for inclusive development and economic growth. He mentioned that the Ministries of Science and Technology and Earth Sciences are actively cooperating with 44 countries world over. Emphasising on capacity building in the academic research arena, he said that for creating an ecosystem of fundamental research as a pathway for technology development and innovation, R&D and academic institutions need to be more globally connected to understand and incorporate the best practices. He emphasised that it can enable the country to leapfrog by avoiding pitfalls and making best use of the collective learning and experiences. Dr. Harsh Vardhan said that with international and bilateral collaborations, India has now started to address together societal grand challenges using the tools of technology and innovation. He enumerated that the scientists are collaborating internationally in wide fields ranging from basic sciences to mega science discovery programmes, trying to invent new vaccines for Zika, TB, Malaria and Dengue, inventing new smart material solutions for clean energy and climate change mitigation, trying to improve crop productivity, studying the water cycle and weather forecasting including monsoon forecasting and natural disaster prediction and management as well as developing Artificial Intelligence based solutions, among others. Dr. Harsh Vardhan said that the Conclave has provided an opportunity to hear from our distinguished guests how they are making the science and technology an effective tool for socio-economic development of their respective countries. He said that it will help everyone to charter a road map of cooperation for their countries and with India on a bilateral level that can foster research and education in this area. ]]> https://biospectrumindia.com/news/22/15021/govt-launches-imi-2-0-portal-for-full-immunization.html https://biospectrumindia.com/news/22/15021/govt-launches-imi-2-0-portal-for-full-immunization.html Fri, 01 Nov 2019 09:35:00 +0530 “As we mark and celebrate 25 years of the Pulse Polio Programme, it is now time to aim at 100% Full Immunization Coverage and ensure that not even one child or pregnant woman dies of Vaccine Preventable Diseases (VPDs)” said Dr Harsh Vardhan, Union Minister for Health & Family Welfare. 2nd Oct, 2019 marked 25 years of the first Pulse Polio campaign in Delhi, which was later adopted and implemented by Government of India as Pulse Polio Campaign across the country. The implementation of Polio Supplementary Immunization Activity played a key role in India’s attainment of polio-free status in 2014. This achievement was coined by the WHO as “one of the most significant achievements in public health,” and marked not just India but the entire South East Asia Region being declared polio-free. J.P Nadda, former Health Minister was the Chief Guest of the event. He congratulated Dr Harsh Vardhan, calling him the Chief Architect of the Polio Programme and commended the Health Ministry for the internationally successful and applauded Programme. Nadda said “As the health systems are robust and surveillance system of the country is very strong, I am very confident that Dr. Harsh Vardhan and his Ministry will achieve the full immunization coverage targets. The PHCs are being converted into Health & Wellness Centres (HWCs), which will ensure that in next 20 years the disease burden in the country is definitely going to decrease. I wish the Intensified Mission Indradhanush 2.0 all the very best”. Ashwini Kumar Choubey, Minister of State for Health and Family Welfare congratulated Dr Harsh Vardhan calling him ‘Polio Senapati’ and his entire team and other stakeholders for their tremendous efforts to eliminate polio from the country. Nadda encouraged all the health sector participants by telling them that their work and efforts do not show immediate results but it is these two drops and vaccinations that build a strong and healthy citizen in the long run, so they should continue working with same zeal and rigour to achieve Prime Minister’s dream of new and healthy India by 2022. Dr Harsh Vardhan talked about the new initiatives being taken bythe Ministry of Health and Family Welfare to achieve the target of full immunization i.e. launch of Intensified Mission Indradhanush (IMI) 2.0 from December 2019 to March 2020, wherein several ministries are coming forward to join hands in taking the mission forward.The IMI 2.0 portal, launched at the event, has been designed to capture information on the blockwise target of children and pregnant women to be vaccinated during the IMI drive and also the coverage data during the rounds of activity. The data will be entered at the district level. This will help the Programme officers and administrators at the block, district, state and national level to have real time information on the progress of the campaign and also take timely action on slow progress in any particular area. Dr Harsh Vardhan while reminiscing about the 25-year journey since the beginning of Pulse Polio Campaign, thanked all the partners and stakeholders of the Pulse Polio Programme. He said “I laud the efforts of community and religious leaders who joined hands as advocates of this mission. I cheer for the efforts of the nation’s youth ambassadors, celebrities and sportsmen who supported in building the campaign. I salute the stalwarts of our country, our ASHA workers, ANMs, Anganwadi workers (AWW) who ensured all doors were knocked. I commend the uncompromised commitment and zeal of our state governments, civil society organizations, professional bodies like IMA, IAP, partners such as WHO, Rotary International and UNICEF and most importantly the support of citizens of our country”. Union health Minister added that the level of commitment, accountability and ownership seen in this Programme was unprecedented and has not been witnessed elsewhere in the world. Dr Harsh Vardhan then said that while we are keeping our guards up for polio, Government has opted for a ‘game changing approach’ towards sustaining the gains of immunization, ensuring a healthy and prosperous future for our country. He added that learnings from polio campaign have further provided guidance for rollout of Mission Indradhanush and its intensified drive under the mentorship of our Prime Minister, Narendra Modi. “Our visionary leader, Narendra Modi ji has a dream of a healthy and robust India. It is our duty to contribute to this dream and ensure every child is vaccinated and grows up into a healthy citizen”. Dr Harsh Vardhan concluded by calling upon all states, volunteers, partners, NGOs and other stakeholders to once again come forward and join hands to save every child from VPD, like they did for making India polio free.     ]]> https://biospectrumindia.com/news/22/15018/india-takes-ayurvedic-science-ahead-with-germany.html https://biospectrumindia.com/news/22/15018/india-takes-ayurvedic-science-ahead-with-germany.html Thu, 31 Oct 2019 14:25:00 +0530 An MOU has been signed between All India Institute of Ayurveda (AIIA) under Ministry of AYUSH and Frankfurter Innovationszentrum Biotechnologie GmbH (FiZ). The MoU signed by Prof. Tanuja Nesari Director AIIA and Dr Christian Garbe, Managing Director of Frankfurter Innovationszentrum Biotechnologie GmbH (FiZ), was agreed at FiZ on the occasion of the event “German/Indian knowledge exchange regarding current developments in the health care sector” by Dr Garbe with Vaidya Rajesh Kotecha, Secretary, Ministry of AYUSH, during September of this year. One important goal of the collaboration is to research in the field of genomics and develop evidence-based guidelines supported with latest technologies like Artificial Intelligence and machine learning so as to integrate Ayurvedic principles and practises into modern medicine for the wider reach to the masses. Further, exchange of knowledge and experiences will be another component in the MoU. Speaking after the singing of the MOU, Dr.Vaidya, Secretary, AYUSH said that the systems appear to be quiet different at first glance. On deeper observation, it appears that both the sciences can support each other. Complementing the traditional Ayurveda Medicine with conventional concepts of Biotechnology is expected in generating evidences that further help in contributing to the global healthcare, he added. On this occasion, Dr. Garbe said that for years there have been diverse contacts with India in order to foster both, share experience and know-how in our network and render technological knowledge economically usable as well. He explained that empirical medicine and precision medicine will become productive partners. Director, All India Institute of Ayurveda Prof. Tanuja Nesari said that the Ayurveda is the time tested science focussed upon providing healthy life through wholeness of body, mind, and soul considering different aspects including environmental factors.   ]]> https://biospectrumindia.com/news/22/15014/govt-targets-elimination-of-lymphatic-filariasis-by-2021.html https://biospectrumindia.com/news/22/15014/govt-targets-elimination-of-lymphatic-filariasis-by-2021.html Thu, 31 Oct 2019 13:45:00 +0530 Union Health & Family Welfare Minister, Dr. Harsh Vardhan, announced an aggressive strategy to address and eliminate Lymphatic Filariasis by 2021. Inaugurating the national symposium on ‘United to Eliminate Lymphatic Filariasis’ organized by the National Vector Borne Disease Control Programme (NVBDCP) in New Delhi, he stressed upon the importance of building a mass movement or ‘Jan Andolan’ to address this preventable vector borne disease which affects is still endemic in 160 districts across India. The minister in his address during the symposium said, “Elimination by 2021 is possible if we foster greater collaboration and commitment by all stakeholders including global public health experts, national & state representatives, partners & donors. Strategies like Triple Drug Therapy or IDA [Ivermectin, diethylcarbamazine (DEC) and Albendazole] with strengthened program delivery and robust community engagement are required to improve the quality of Mass Drug Administration (MDA) rounds”. Dr. Harsh Vardhan reiterated the Government’s commitment towards achieving elimination by 2021.   The national symposium brought over 300 participants including stakeholders including global and national public health experts, partners & donors, research organizations, pharmaceutical companies deliberated on building a common vision towards achieving the elimination of Lymphatic Filariasis. This included the Principal Secretaries, Health and Family Welfare from the states of Uttar Pradesh, Maharashtra, Jharkhand and the Mission Director- National Health Mission, Government of Bihar who shared learnings and best practices from the recent pilot rollout of IDA in these states. The day long deliberation by the national and international experts on addressing Lymphatic Filariasis concluded with the following recommendation and commitments:   A multi-sectorial integrated approach to the implementation of LF elimination program goals that improve national coordination, facilitates partner collaboration, improved vector control and management. Successes from the other national health programs like polio eradication programme, best practices undertaken by states in the IDA pilot districts will be scaled up in all endemic districts. A ‘Mission Mode’ approach will be adopted to meet the elimination target by 2021 and adequate finances and resources will be allocated by the Ministry of Health and Family Welfare. Improved communication and social mobilization have significant impact on dissemination of messages on the need and benefits of MDA to the community. Various channels of social mobilization will be leveraged for improving awareness among communities living in endemic districts. Political and programmatic prioritization at the national and state level will be essential to improve programme visibility and trust among communities about the benefits of preventive drugs administered to the at-risk communities. Mass movement (Jan Andolan) like undertaken for POSHAN Abhiyaan and FIT India movement need to be adopted to reach every household for accelerating elimination efforts. Collaborations with organizations such as NITI Aayog, ICMR, Ministry of AYUSH and other research institutions will be explored to improve programme delivery and effectiveness. Access to Morbidity Management and Disability Prevention services through a basic package will be ensured. Capacity-building of the peripheral health staff/volunteers for early management and referral will serve as the backbone for making an impact on the ground. Access to people suffering from hydrocele through surgical correction will be ensured at public health facilities free of cost. The symposium was also attended by senior ministry of health dignitaries including Preeti Sudan, Union Secretary, Ministry of Health & Family Welfare; Dr. Sanjay Tyagi, Director General Health Services, Ministry of Health & Family Welfare; Manoj Jhalani, Special Secretary & Mission Director (NHM), Ministry of Health & Family Welfare, Government of India; and Rekha Shukla, Joint Secretary, Ministry of Health & Family Welfare. Other senior dignitaries included Professor Vinod K Paul, Member, National Institution for Transforming India (NITI) Aayog; Professor Balram Bhargava, Director General, Indian Council of Medical Research (ICMR); Vaidya Rajesh Kotecha, Secretary, Ministry of AYUSH; Dr. Payden, Deputy Head World Health Organization Representative to India and M. Hari Menon, Country Director, India, Bill & Melinda Gates Foundation. ]]> https://biospectrumindia.com/news/22/15004/health-minister-urges-stakeholders-to-timely-implement-ndhb.html https://biospectrumindia.com/news/22/15004/health-minister-urges-stakeholders-to-timely-implement-ndhb.html Wed, 30 Oct 2019 06:00:00 +0530 Urging the stakeholders to work towards implementing the National Digital Health Blueprint (NDHB) in a time bound manner, Union Minister of Health and Family Welfare Dr. Harsh Vardhan said that “Government of India is committed to ensuring high quality healthcare, accessible to all upto the last mile. The digital health interventions are accelerating this transformation and have a huge potential for supporting Universal Health care.” J. Satyanarayana, Former Chairman, UIDAI and Chairman of the National Digital Health Blueprint (NDHB) Committee has submitted the final NDHB report to Dr. Harsh Vardhan. J. Satyanarayana provided a brief overview of the efforts that have gone into preparation of NDHB report and made a brief presentation on the overall framework as proposed in NDHB. He said that the priorities of Government of India in health care were included in the National Health Policy 2017 and this recommendation report by Ministry of Health and Family Welfare has shown the implementation angle for achieving the same. He further added that this may be considered as the biggest leap of GoI towards achieving the goal of Universal Healthcare Coverage (UHC) with impetus on Digital Healthcare component. Dr. Harsh Vardhansaid that “The need of the hour is to create an ecosystem which can integrate theexisting disparate health information systems and show clear path for upcoming programmes. There is a need to ensure convergence across these IT systems to monitor and provide health services in a robust and efficient manner. Ministry of Health and Family Welfare has initiated efforts in the direction of a comprehensive, nationwide integrated e-Health system under National Digital Health Blueprint.” NDHB will help in providing a common platform for integration of existing applications in health domain and data which has existed in silos, either in public health facility, or, in private healthcare facility, in India. It was also updated that building on the initial document of “National Health Stack” (NHS) by NitiAayog, Ministry of Health and Family Welfare has defined clear timelines, targets and the resources required for this digital convergence of Healthcare programmes in India. Speaking at the event, Dr. Harsh Vardhan referred to vision of Hon’ble Prime Minister of India, Narendra Modi, to reach each individual of this country with services at their doorstep under Digital India Programme and hoped that implementation of NDHB with programmes of Ministry of Health and Family Welfare would benefit every individual. He congratulated Preeti Sudan, Secretary, Ministry of Health and Family Welfare and J.Satyanarayanafor this extensive exercise which would transform India into a Digital healthcare economy and urged all stakeholders to work towards implementing the blueprint in a time bound manner. ]]> https://biospectrumindia.com/news/22/14992/govt-releases-guidelines-for-evaluation-of-nanopharmaceuticals.html https://biospectrumindia.com/news/22/14992/govt-releases-guidelines-for-evaluation-of-nanopharmaceuticals.html Mon, 28 Oct 2019 11:00:00 +0530 The Union Minister for Science & Technology, Earth Sciences and Health & Family Welfare, Dr. Harsh Vardhan has released “Guidelines for Evaluation of Nanopharmaceuticals in India”, at an event in New Delhi recently. Dr. Harsh Vardhan informed that these “Guidelines for Evaluation of Nanopharmaceuticals in India” is one of the most important steps for delineating quality, safety and efficacy assessment of the novel nanoformulations. He further added that these guidelines are intended to provide transparent, consistent and predictable regulatory pathways for nanopharmaceuticals in India. Nanocarrier based targeted drug delivery is an emerging field with introduction of nanopharmaceuticals in the market. These nanoformulations have higher efficacy, lower toxicity and are safer than the conventional drugs. Indian researchers would be facilitated to undertake research in line with the regulatory guidelines and is expected that Industry would be keen to participate from the beginning of the research pipeline towards product development and commercialisation. Further, private investments would also be attracted since these guidelines would strengthen the regulatory system. The guidelines apply to the nanopharmaceuticals in the form of finished formulation as well as Active Pharmaceutical Ingredient (API) of a new molecule or an already approved molecule with altered nanoscale dimensions, properties or phenomenon associated with the application of nanotechnology intended to be used for treatment, in vivo diagnosis, mitigation, cure or prevention of diseases and disorders in humans The guidelines would facilitate translational research in line with the regulatory requirements. Guidelines will also facilitate the decision making by regulator during clearances to newer products based on nanotechnology and similarly to researchers to get clearance for their products to launch in market. End users will also be benefited by the quality assured anticipated products in the market in accordance to the guidelines. This document will give impetus to initiate activities for developing safety guidelines for other domains like agri-inputs and agri-products, cosmetics, implantable devices, through interventions of nanotechnology. The guidelines will pave the way for significant benefits through such cutting edge technology and contribute to the mission on “Affordable Health Care for All”. The Guidelines are developed by Department of Biotechnology (DBT), Ministry of Science and Technology, Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare and is an outcome of all concerned Inter-Ministerial efforts coordinated by DBT. ]]> https://biospectrumindia.com/news/22/14983/cabinet-approves-mou-with-st-vincent-the-grenadines.html https://biospectrumindia.com/news/22/14983/cabinet-approves-mou-with-st-vincent-the-grenadines.html Thu, 24 Oct 2019 10:50:00 +0530 The Union Cabinet chaired by the Prime Minister Narendra Modi has given ex post-facto approval to theproposed Memorandum of Understanding (MoU) between India and St. Vincent & the Grenadines on cooperation in the field of Traditional Systems of Medicine. The MoU was signed at New Delhi on 11th September 2019. The MoU will provide a framework for cooperation between India and St. Vincent & the Grenadines for the promotion of traditional systems of medicines and will mutually benefit the two countries in the said field. It will lead to promotion and propagation of Traditional Systems of Medicine in St. Vincent & the Grenadines. Activities mentioned in the MoU will boost the importance of AYUSH Systems of Medicine in St. Vincent & the Grenadines. As a consequence of the MoU, exchange of experts for training of the practitioners and Scientists undertaking collaborative research in Traditional Systems of Medicine are expected to lead to new innovations in drug development and practice of Traditional Medicine. ]]> https://biospectrumindia.com/news/22/14945/karnataka-co-creates-innovative-solutions-with-the-netherlands.html https://biospectrumindia.com/news/22/14945/karnataka-co-creates-innovative-solutions-with-the-netherlands.html Mon, 21 Oct 2019 07:00:00 +0530 Life Sciences and Healthcare (LSH) is a priority sector under bilateral collaboration between India and the Netherlands. Growing market opportunities in India, combined with the Netherlands’ strengths in areas such as Therapeutics & Vaccines, Medtech and Digital Health create excellent opportunities for partnerships that address shared societal challenges with smart solutions and make India a valuable partner for the Dutch LSH Sector. The affordability and accessibility of healthcare remains at the core of partnerships between the Indian and the Dutch stakeholders. On the 17th and 18th of October, more than 80 companies and knowledge institutes from the Netherlands in the fields of Life Sciences & Healthcare (LSH) and Horticulture & Agriculture visited Bengaluru. Heading the delegation were Dutch Minister for Medical Care and Sport, Bruno Bruins, Chair of the Top Sector Life Sciences & Health, Carmen van Vilsteren, Vice Minister of Agriculture, Marjolijn Sonnema and Chairman of the Topsector Horticulture & Starting Materials, Loek Hermans. To encourage partnerships around important themes of affordability and accessibility, a Healthcare Seminar was organised at Hotel Four Seasons in Bengaluru that brought together government officials, healthcare practitioners, med-tech companies, IT companies, academic institutes and start-ups. The Ministerial and business delegation also visited Philips Innovation Campus, Centre for Cellular & Molecular Platforms (C-CAMP), Narayana Health City and Anthem Biosciences. 4 MoUs were signed during a Holland Trade Reception hosted by Consul-General of the kingdom of the Netherlands in Bengaluru, Gert Heijkoop. The overview is given below: Co-development Agreement between Dutch company, CareAnimations and National Institute for Mental Health and Neuro Science, Bengaluru to co-develop animated videos aimed at mass population to increase awareness and acceptance of mental disorders and stimulate the willingness to seek professional help. MoU between Dutch company CareAnimations and Centre for Social Action, Christ University Bengaluru to develop animated videos aimed at people in urban slums to increase awareness, understanding and willingness to act with regard to a range of Public Health issues, such as clean drinking water, sanitation, education, substance abuse, etc. MoU between Dutch company, CareAnimations and AIC-Octo Spaces Incubator Services Private Limited, Hyderabad to explore synergies in improving Indian private hospital sector with better patient service, patient outcome es, patient satisfaction and patient retention, combined with higher efficiency and productivity. Cooperation agreement on the joint center on genome stability between Erasmus University Medical Centre, Rotterdam and Manipal Academy of Higher Education (MAHE) to establish advanced cutting-edge research in DNA damage response defects, genome stability and therapeutic applications. The two sides will also develop co-supervised PhD programmes, to strengthen capacity building. Calling Bengaluru, Brainport of India, Dutch Minister for Medical Care and Sport, Bruno Bruins said, "The State of Karnataka is an important partner for the Netherlands regarding health. It is impressive to see how the Bangalore biotech cluster is helping to drive new scientific breakthroughs and innovations. Not only on antimicrobial resistance but also on digital health, medical devices and diagnostics. I see a lot of opportunities for and positive energy between Dutch and Indian companies and knowledge institutes to work together on affordable and accessible healthcare for all. A challenge not only in the Netherlands but also in India. Building up a healthcare infrastructure for everyone is a hard nut to crack. At the same time there are unique opportunities by using new data-technology, ICT and e-health. Working together on our mutual challenges will help us both to improve the national and global health”. ]]> https://biospectrumindia.com/news/22/14943/niti-aayog-launches-india-innovation-index-2019.html https://biospectrumindia.com/news/22/14943/niti-aayog-launches-india-innovation-index-2019.html Fri, 18 Oct 2019 11:55:00 +0530 Recognizing the role of innovation as a key driver of growth and prosperity for India, NITI Aayog with Institute for Competitiveness as the knowledge partner has released the India Innovation Index 2019. The study is an outcome of extensive research and analysis, which looks holistically at the innovation landscape of India by examining the innovation capabilities and performance of Indian states and union territories. The aim is to create a holistic tool which can be used by policymakers across the country to identify the challenges to be addressed and strengths to build on when designing the economic growth policies for their regions in different areas such as healthcare, agriculture, startups etc.The index attempts to create an extensive framework for the continual evaluation of the innovation environment of 29 states and seven union territories in India and intends to perform the following three functions: 1) ranking of states and UTs based on their index scores, 2) recognizing opportunities and challenges, and 3) assisting in tailoring governmental policies to foster innovation. The index shows that the innovation ecosystem of the country is strong in south and western parts of India. In fact, three of the top five major states are from southern India. Delhi and Haryana seem to be an exception to this rule and seem to be doing well on the Index. Thus, there seems to be a west-south and north-east divide across the country. Karnataka is the leader in the overall rankings in the category of major states. Karnataka’s number one position in the overall ranking is partly attributed to its top rank in the Performance dimension. It is also among the top performers in Infrastructure, Knowledge Workers, Knowledge Output and Business Environment. ]]> https://biospectrumindia.com/news/22/14880/health-ministry-urges-states-to-increase-healthcare-spending.html https://biospectrumindia.com/news/22/14880/health-ministry-urges-states-to-increase-healthcare-spending.html Thu, 10 Oct 2019 16:40:00 +0530 Urging the participating Health Ministers from States/UTsto increase healthcare spending to a minimum 8% of their State budget so as to meet the goals of healthcare spending of National Health Policy 2017- 2.5% of GDP by 2025, Union Minister for Health & Family Welfare Dr. Harsh Vardhan stated that “From the first CCHFW meeting to today, we together have achieved several health milestones, especially India being certified Polio-free. This has been possible because of our collaborative efforts. If all Health Ministers come together for a cause, no task can be impossible.” He was inaugurating the 13th Conference of the Central Council of Health and Family Welfare (CCHFW), in the presence of Ashwini Kumar Choubey, MoS (HFW), Dr V K Paul, Member (Health), Niti Aayog, Preeti Sudan, Secretary (HFW), and Health Ministers from 13 states, in New Delhi. Speaking at the event, Dr Harsh Vardhan stated that the purpose of the CCHFW meeting is to build a consensus on the national health priorities i.e. Universal Health Coverage (UHC) through Ayushman Bharat, eliminating TB and other priority agenda such as strengthen medical infrastructure. This can be achieved by collective increase in healthcare spending by the States/UTs to meet the goals of healthcare spending of National Health Policy 2017- 2.5% of GDP by 2025. “This is the first time that a government is so committed to healthcare and health care is on the top agenda. This is clearly visible from the passionate address of our Prime Minister Shri. Narendra Modi ji at the recently concluded UN General Assembly where he stressed upon four pillars of healthcare, which included universal health coverage; mission mode interventions; quality and accessible affordable healthcare services; and also adequate infrastructure.  Dr Harsh Vardhan further stated “Health needs to become a social movement in every State & UT and the Eat Right and Fit India movements need to be taken up by States & UTs in a synergized manner, to ensure a healthy & robust India”. The Minister also urged the Health Minister of Uttar Pradesh, who is also the Finance Minister of the State, to increase the health budget of the State and set an example for the rest to emulate. Speaking at the occasion, Preeti Sudan, Secretary (HFW) said that the health Ministry is dedicated to the cause of effective, affordable, quality and accessible healthcare. She added that the CCHFW is integral to achievement of health goals of the country, “Without the political leadership and commitment of the States & UTs, healthcare cannot be effective”, she added. Dr Vinod K. Paul, Member, NITI Aayogunderscored two priority areas for the public health sector. “First is increasing the health budgets by the Centre and the States/UTs, and second in enhancing the health infrastructure. The NHP 2017 commitment to increasing the health budget cannot be achieved without States contribution”, he stated. He added that there is a need to engage more with the private sector for augmenting the efforts of the public sector to bring in equity to increase the number of beds and hospitals to meet the global standards of health infrastructure. The Council of Health and Family Welfare is an apex advisory body to consider and recommend broad lines of policy in regard to matters concerning Health and Family Welfare, in all its aspects.  Union Minister for Health & Family Welfare is the Chairperson, while Minister of State for Health & Family Welfare is the Vice-Chairperson. Member, NITI Aayog, Ministers in charge of the Ministries of Health & Family Welfare, Medical Education and Public Health in the States/Union Territories with Legislatures, representatives of UTs, Members of Parliament (4), Non-Officials (6), Eminent Individuals (11) are Members of the Council. The first meeting of the CCHFW was held in 1988. The Conference would deliberate on various issues in seven sessions, spread over 1 ½ days.  At the inaugural session, Dr Harsh Vardhan along with the other Ministers launched a new initiative – ‘Surakshit Matritva Aashwasan (SUMAN)’ for Zero Preventable Maternal and Newborn Deaths, its website and the grievance redressal portal.  As today is also the World Sight day, Dr Harsh Vardhan released the Report on National Diabetes & Diabetic Retinopathy Survey India 2015-19 and Report on National Blindness & Visual Impairment Survey India 2015-19 prepared with the support of AIIMS, New Delhi. In addition, along with other dignitaries, he also unveiled two info-leaflets on Suicide Prevention to mark the World Mental Health Day. Additionally, he released Guidelines on Drugs and Diagnostic Service Initiative; Guidelines for Biomedical Equipment Management & Maintenance Program; and the Guidelines for Peritoneal Dialysis under Pradhan Mantri National Dialysis Program. On the agenda of the conference are issues of relevance in the present context.  Ayushman Bharat- PMJAY  and Health and Wellness Centres (HWCs), National  Health Mission –Health Systems Strengthening, Communicable Diseases (TB control, Vector Borne Diseases Programme, Leprosy Control, Viral Hepatitis Control) and National AIDS Control programme, Reproductive Health, Maternal Health, Child Health, Immunization, Adolescent Health,  Non Communicable Diseases  (Mental Health Programme,  Cardio-Vascular Diseases, Cancer, Diabetes, Healthcare for the Elderly, Control of Blindness) and  Tobacco Control, Regulation in Medical Education, Food and Drugs, National Organ Transplant Programme, Clinical Establishments Act, PMSSY and e-Health.  ]]> https://biospectrumindia.com/news/22/14847/aimed-bcil-address-comprehensive-regulation-of-medical-devices.html https://biospectrumindia.com/news/22/14847/aimed-bcil-address-comprehensive-regulation-of-medical-devices.html Mon, 07 Oct 2019 16:45:00 +0530 First joint conference “Comprehensive Regulation of Medical Devices” was organized by Association of Indian Medical Device Industry (AiMeD) & Biotech Consortium India Limited (BCIL) supported by Department of Pharmaceuticals (DoP) was recently organized in New Delhi. 1st Govt. & Indian Manufacturers Conference on Comprehensive Regulation of Medical Devices Calls for a Separate Medical Device Patient Safety Law Separate from Drugs Rajiv Nath, Forum Coordinator, AiMeD & Dr. Purnima Sharma, MD, BCIL along with other dignitaries of the Government, Industry, Academia & Indian Medical Device Industry Associations were part of this conference. Dr. Vinod Paul, Member, NITI Aayog during his inaugural emphasized on the need for integrated efforts to promote innovations and development of indigenous medical devices for having a vibrant domestic medical devices industry for the society. He assured full support of NITI Aayog to ensure that the intent of domestic industry to provide access to safe, effective and quality medical device to the patients are kept in all Govt. policies. Dr. V.G Somani, DCGI, CDSCO said “Regulations need to encourage – Make in India & Made in India.  To improve Brand value, credibility and acceptance of Made in India Medical devices, all Medical Devices need to be regulated at one go and not item by item.” Dr. Vinod Paul & Dr. V.G Somani allayed apprehensions of the medical device industry and assured to regulate all medical devices in a phased manner rather than item by item in a stipulated time frame starting with voluntary registration for manufacturers & importers and voluntary compliance to Medical Devices rules while an eco-system is built up with infrastructure along with adequate team of competent officers. The opening session threw light on the Need for Comprehensive Regulation of Medical Devices in India. Rajiv Nath pointed out the need to regulate all Medical Devices under a Patients’ Safety Medical Devices Law to protect patients and aid responsible manufacturing. Gurmit Chugh, Jt. Coordinator (AiMeD) said, “The Manufacturers have been confused with informally choosing of Products and notifying them as Drugs. They seek a predictable and comprehensive regulatory framework that allows for adequate transition and is predictable. Only then will investments speed up as they get discouraged to be regulated as Drugs.” The first technical session on Comprehensive Regulation of Medical Devices highlighted the current state of the beleaguered Indian Medical Devices domestic industry. The urgent need for the Government to expedite steps to end the 80-90% import dependence forced upon us and an ever increasing import bill of over Rs 38,837 Crore, expedite steps for patients’ protection, stronger quality & Safety regulations, price controls to make medical devices and quality treatment accessible and affordable and ethical indigenous manufacturing viable . MSME dominated medical domestic manufacturing took a hit post GST as imports become 11% cheaper and shoot up 24%. Imports of medical devices are up by record 24 % at 7450 Cr ₹ from ₹31386 Cr in 2017-2018 to 38,837 Cr ₹ in 2018-2019. GST on medical devices is in favour of imports and is detrimental to Make in India. MSME sector has been worst hit with huge job losses Voicing the concerns of Domestic Medical Devices Industry, Rajiv Nath said “Medical Devices are not Drugs though both are medical products but differ in approach in marketing. We have been specifically seeking Trade Margin Caps on Devices notified as Drugs but from 1st point of sale in Supply Chain, which as per us is when 1st sale takes place and GST is applied 1st time e.g. when goods enter country (on the CIF import landed price for imported and Ex-factory price for Indian). This will maintain parity between Indian & overseas manufacturers. GoI needs to take policy decisions to give at least a level playing field, if not a strategic advantage to domestic manufacturers while safeguarding consumers.” Priority issues raised during the conference are: Need to regulate all Medical Devices under a Patients’ Safety Medical Devices Law to protect patients and aid responsible manufacturing Need to protect Consumers from exploitatively high MRP in Medical Devices by rationalized price controls and aid ethical marketing Need to encourage employment and Make in India of Medical Devices and address 80-90% import dependency by a predictive nominal tariff protection policy as done for mobile phones to ensure a vibrant domestic industry & competitiveness and price stability driven by competing domestic players Need to incentivize Quality in Healthcare Products in public healthcare procurements by preferential pricing for Q1 e.g. ICMED (QCI’s Indian Certification for Medical Devices) instead of L1 (lowest price) to ensure patients access acceptable quality must ensure importers of Medical Devices are not kept out of the move to cap Trade Margins ]]> https://biospectrumindia.com/news/22/14828/health-ministry-collaborates-with-who-to-re-design-nhsrc.html https://biospectrumindia.com/news/22/14828/health-ministry-collaborates-with-who-to-re-design-nhsrc.html Fri, 04 Oct 2019 11:15:00 +0530 The Ministry of Health and Family Welfare in collaboration with World Health Organization (WHO) formally announced the re-designation of National Health Systems Resource Centre (NHSRC), as the WHO Collaborating Centre for Priority Medical Devices and Health Technology Policy. The mandate of the Division of Healthcare Technology at NHSRC is to draw up technical specifications for technologies procured under National Health Mission, draft policies for medical device maintenance and management, undertake evaluations of health product innovations, conduct Health Technology Assessments (HTA), and support the Ministry of Health and Family Welfare on issues related to diagnostics initiative, National Dialysis Program and other technology intensive services. In the past, NHSRC as a collaborating centre has supported WHO in formulating technical specifications for medical devices such as oxygen concentrators and resuscitation devices and continues to support evaluation of innovations for WHO’s compendium on innovative devices. This year in collaboration with WHO’s country’s office, NHSRC developed a guidance document for the Ministry’s free diagnostics initiative to further strengthen the agenda of Universal access to affordable diagnostics. NHSRC also works with WHO on development of technical specification of Blood pressure measuring devices, In vitro diagnostics and devices for cancer and cardiovascular diseases. Future collaboration includes work on International Classification and Nomenclature for Medical Devices, which would improve access to affordable health technologies. Such global collaborations in the area of health technology will ensure that scientific and technological advances, research and development as well as innovative technologies play a substantial supportive role in healthcare and enable us to reach the public health goals and achieve universal health coverage. ]]> https://biospectrumindia.com/news/22/14790/nha-revises-health-benefit-packages-of-ayushman-bharat.html https://biospectrumindia.com/news/22/14790/nha-revises-health-benefit-packages-of-ayushman-bharat.html Mon, 30 Sep 2019 12:40:00 +0530 Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (PM-JAY), India’s flagship healthcare scheme provides a cover of Rs. 5 Lakh per family per year to around 50 crore poor and vulnerable individuals. Within one year of the scheme, 46.5 lakh hospital treatments were provided, amounting to claims worth Rs 7,490 crores. 53% of the treatments were provided in private hospitals, and 60% were for tertiary care. National Health Authority (NHA), the nodal agency for implementation of PM-JAY stated that the Health Benefit Packages (HBP) of the scheme have been revised. There has been an increase in the rate of 270 packages, addition of 237 new packages, adoption of 43 stratified packages; and there is no change to the rate of 469 packages.  NHA also mentioned that without compromising the range of treatment covered under PM-JAY, 554 packages will be discontinued, and there is a reduction in the rate of 57 packages. Overall, a conscious attempt has been made to keep the price of abuse prone packages at the minimum level to minimize incentives for abuse. Dr. Harsh Vardhan, Union Minister of Health and Family Welfare, said “We are confident that with the revision in the Health Benefit Packages of Ayushman Bharat PM-JAY, many new private hospitals will get empanelled with the scheme. This will help improve the access to good quality healthcare, and lakhs of vulnerable families will receive free treatment.” Currently, PM-JAY has 1,393 treatment packages out of which 1,083 are surgical, 309 medical and 1 unspecified package. As per NHA, “Since the launch, it had been receiving feedback on various aspects of the scheme including existing HBP and their rates. The Governing Board of NHA took a serious note of that and decided to undertake an exercise to remove the aberrations and anomalies in the HBP. A vigorous and scientific procedure was followed. NHA along with the Department of Health Research (DHR), Indian Council of Medical Research (ICMR) and Tata Memorial Hospital consulted specialist committees, which helped remove the inconsistencies in the nomenclature and pricing for their respective specialties.” The specialist committees examined the relevant sections of HBP and made suggestions, the review committee examined the suggestions made by the specialist committees and moderated them, and finally the recommendations of the review committee were put up to the Governing Board for approval. In this  Governing Board meeting, Dr. Vinod Paul, Member, NITI Aayog and Dr. Balram Bhargava, Secretary, Department of Health Research were invited to participate in the discussions as special invitees. Dr. Indu Bhushan, CEO NHA explained “In the spirit of cooperative federalism, before finalizing the changes, feedback was also taken from the States and Union Territories. Their feedback was examined by the review committee”. He added “States/UTs which are using insurance model or a combination of Trust and insurance model shall have autonomy to either continue using existing package master till their current contract period ends or shift to the new version after making suitable amendments in their contract.” The revised oncology packages will revamp cancer care for the beneficiaries and are aligned to reflect the current best practices in the country.  Dr. Harsh Vardhan explained “These revised rates are expected to further augment cancer care in the country, along with drastic reduction in the catastrophic expenses associated with it. Oncology packages have been split, to include multiple regimens of surgical and medical oncology, complemented by radiotherapy regimens.” NHA added that a conscious attempt has been made to standardize the nomenclature and definitions of the packages. NHA, in collaboration with World Health Organization (WHO), has initiated the process of aligning the HBP with International Classification of Health Interventions (ICHI) and International Classification of Diseases (ICD) coding of the WHO. When completed, India may become the first country to use ICHI in its HBP list. Several innovative concepts were used by NHA while revising the packages such as cross specialty packages, stratified packages and add-on packages which will enhance the ease of selecting the right package for the empanelled hospital. NHA said that in preparation for the future, it is planning to configure the cost of implants / high-end consumables in its IT system separately at the backend. This will be useful whenever there is a movement in the price of these significant components of a package cost. NHA said that it is confident that with the restructuring and rationalization of the HBP of PM-JAY, the concerns of various stakeholders will be addressed, more private hospital will get empanelled, and more poor beneficiaries will be able to avail of their entitlements. This will take India one step closer towards its goal of Universal Health Coverage. PM-JAY has 1,393 treatment packages out of which 1,083 are surgical, 309 medical and 1 unspecified package. The package includes the cost of diagnostics up-to 3 days before hospitalization, and medicines up to 15 days post hospitalization.   ]]> https://biospectrumindia.com/news/22/14752/government-launches-ummid-initiative-to-tackle-inherited-diseases-.html https://biospectrumindia.com/news/22/14752/government-launches-ummid-initiative-to-tackle-inherited-diseases-.html Tue, 24 Sep 2019 11:55:00 +0530 The Union Minister for Science & Technology, Earth Sciences and Health & Family Welfare, Dr. Harsh Vardhan has launched UMMID (Unique Methods of Management and treatment of Inherited Disorders) initiative and inaugurated NIDAN (National Inherited Diseases Administration) Kendras, which is being supported by Department of Biotechnology (DBT) &  Science and Technology. Speaking on the occasion Dr Harshvardhan brought attention to the issue of ensuring proper treatment to children and creation of awareness amongst the masses and urged upon all to dwell more into finding solutions. Congratulating DBT for supporting this path-breaking initiative, he said “With the program being implemented at government hospitals, people who cannot afford expensive care for genetic disorders will be benefited”. He further emphasized on the use of cutting edge scientific technology and molecular medicine for extending Universal Health Coverage for all. Dr. Renu Swarup, Secretary, DBT also highlighted how UMMID is a path-breakinginitiative in the health-care sector. She said “UMMID initiative is meeting the hopes of large number of persons with inherited diseases”. Taking into account that congenital and hereditary genetic diseases are becoming a significant health burden in India, and realizing the need for adequate and effective genetic testing and counselling services. DBT has started the UMMID Initiative which is designed on the concept of ‘Prevention is better than Cure’. In India’s urban areas, congenital malformations and genetic disorders are the third most common cause of mortality in newborns. With a very large population and high birth rate, and consanguineous marriage favored in many communities, prevalence of genetic disorders is high in India, the UMMID initiative aims (i) to establish NIDAN Kendras to provide counselling, prenatal testing and diagnosis, management, and multidisciplinary care in Government Hospitals wherein the influx of patients is more, (ii) to produce skilled clinicians in Human Genetics, and (iii) to undertake screening of pregnant women and new born babies for inherited genetic diseases in hospitals at aspirational districts. As a part of this initiative, in the first phase, five NIDAN Kendras have been established to provide comprehensive clinical care. Training Centres at Madras Medical Mission- Chennai; SGPGIMS- Lucknow; CDFD – Hyderabad; AIIMS- New Delhi; MAMC- New Delhi; NIIH- Mumbai and CMC Vellore have been supported to provide training in Biochemical Genetics, Cytogenetics, Molecular Genetics, and Clinical Genetics to the clinicians from government hospitals. Screening of 10,000 pregnant women and 5000 new born babies per year for inherited genetic diseases will be taken up at the following seven aspirational districts. The department is planning to expand the program and establish more Nidan Kendras in other parts of the country, train more clinicians in clinical genetics and cover more aspirational districts for screening of pregnant women and new born babies for inherited genetic diseases to provide comprehensive clinical care, in the next phase under this UMMID initiative.   ]]> https://biospectrumindia.com/news/22/14731/karnataka-to-set-up-innovation-authority.html https://biospectrumindia.com/news/22/14731/karnataka-to-set-up-innovation-authority.html Mon, 23 Sep 2019 09:00:00 +0530 “Karnataka State is on a mission to promote faster and inclusive growth. We recognize the prominence of IT to achieve this goal and we will announce a revised IT Policy in the coming days. The policy will focus on attracting investments and generating employment in Tier-2 and Tier-3 cities. To support latest technologies, we are going to set up the ‘Karnataka Innovation Authority’” said B. S. Yediyurappa, Chief Minister, Government of Karnataka. Yediyurappa was speaking after holding interactions in Bengaluru on September 19 with vision group members, senior officials of the IT BT and ST Department, Government of Karnataka and industry captains of the IT and Biotechnology space. They also held interactive sessions with Consul Generals and diplomats from over 15 countries including Britain, Israel, Netherlands, Japan, Switzerland, Denmark and Sri Lanka. Yediyurappa further said “the ‘Karnataka Innovation Authority’ will be set up under my chairmanship with my colleague Dr. C N Ashwath Narayan as the co-chairman. I am also pleased to announce that we will constitute a Vision Group for Startups, to provide insights on strengthening the startup ecosystem, while involving key stakeholders from industry and academia.” He urged the industry to invest in cities like Mysuru, Mangaluru, Hubbali-Dharwad, Shivamogga and Belagavi, where vibrant ecosystems already exist. Dr. C. N. Ashwath Narayan, Deputy Chief Minister and Minister for IT, BT and S&T, Government of Karnataka said, “The State of Karnataka is recognized as a global leader in innovation, technology and R&D with Bengaluru being the 4th Largest Technology Cluster in the World and one of the top global innovation hubs, along the lines of New York, Tokyo, London, Beijing, Tel Aviv, etc. In order to further enhance our position as a global innovator, the Government of Karnataka will establish a ‘Legal Framework for Innovation’ with the aim to encourage new and emerging technologies in the State. We are working on a draft bill which proposes to establish a mechanism for the creation of Regulatory Sandboxes in Karnataka, which will broadly describe a set of conditions under which innovative technologies can be tested in a controlled testing environment, by relaxing regulatory requirements. These initiatives will be formally announced at this year’s Bengaluru Tech Summit.” “Our Government has adopted a multi-faceted approach to ensure Karnataka remains the national leader in innovation and enhances its place in the global economy. Our focus would be on skilling, incubating startups, developing global alliances, concentrating on Tier II cities and providing a legal framework for supporting innovation. The Government has laid strong emphasis on university engagement in tier II and tier III Cities which is done through the New Age Innovation Network (NAIN) program which currently covers 30 Engineering Institutions. Through NAIN 293 Projects have been funded and over 100 working prototypes have been realized. We hope to see more R&D and innovation from these universities and academic institutions in the future.” Dr. Ashwath Narayan added. In his welcome address, Dr. E. V. Ramana Reddy, Additional Chief Secretary, Department of IT, BT and S&T said, “The Government of Karnataka has played an important role in bringing in new technologies to the State and in creating a vast talent pool of skilled human resources to catapult innovation. We have created a system of Global Innovation Alliances (GIAs) to explore collaboration with countries who are innovating at a rapid pace. We currently have around 15 GIA partners and the stakeholders in these countries include Governments, academic institutions, startup incubators, universities, and large tech companies. The Department is also mulling an MNC Engagement Strategy as well for continued interaction with MNCs.   (photo caption: B. S. Yediyurappa, Chief Minister, government of Karnataka (in white dress), posing with vision group members, senior officials of the IT BT and ST Department, Government of Karnataka and industry captains of the IT and Biotechnology space after holding an interactive sessions with them in Bengaluru on September 19.)   ]]> https://biospectrumindia.com/news/22/14726/nathealth-welcomes-corporate-tax-cut-recommends-gst-reforms.html https://biospectrumindia.com/news/22/14726/nathealth-welcomes-corporate-tax-cut-recommends-gst-reforms.html Fri, 20 Sep 2019 14:10:00 +0530 NATHEALTH has dubbed the government’s move to cut down Corporate Tax as progressive and said, rationalisation of tax structure would provide much-awaited booster dose to the sector. Finance Minister Nirmala Sitharaman has announced a big reduction in the income tax rate for corporates. The government has slashed basic corporate tax rate to 22% from 30% while for new manufacturing companies it has been cut down to 15% from 25%. Dr H Sudarshan Ballal, President, NATHEALTH said, “In our pre-budget recommendations, we had recommended a slew of measures related to direct and indirect taxes. It is promising to note that the government paid heed to those urgent measures. Reduction in corporate tax and other relief would create a favourable business climate for the companies which were under tremendous pressure due to several internal and external market forces.” NATHEALTH believes that the corporate tax reduction move would be supplemented by the Goods and Services Tax (GST) reforms as well. The GST Council will be meeting tomorrow in Goa to consider several recommendations to rationalise the rates because of current economic slow and to push the industry. Siddhartha Bhattacharya, Secretary-General, NATHEALTH, said “Since GST is not payable on health care services, health care service providers are not eligible to avail credit on the input taxes paid by it, which ultimately becomes a cost for the service provider. Under the current GST regime, the net impact of revised tax rates on inputs (goods and services) consumed by hospitals has increased. As this incremental cost is ultimately borne by the patients, it defeats the intention of the Government to provide affordable healthcare services.” “NATHEALTH had recommended the Government to consider zero-rating of health care services and health care insurance premiums, which will ensure that the credit chain is intact and that the input taxes are not loaded into the cost of healthcare services. The input tax credit will be available as a refund for the healthcare service providers,” he added. NATHEALTH has suggested an alternative as well. “If the Government decides to persist with the exemption provided for healthcare services, the Government may normalize the rates of tax for the goods and services consumed by the health care service provider and rate of GST on health insurance premium at 5%,”  If the corporate tax cut move is combined with the GST reforms, the sector would get a further boost which will go a long way in ensuring that the dream of Universal Healthcare is translated into reality for the citizens of the country.   ]]> https://biospectrumindia.com/news/22/14707/cabinet-approves-prohibition-of-e-cigarettes.html https://biospectrumindia.com/news/22/14707/cabinet-approves-prohibition-of-e-cigarettes.html Thu, 19 Sep 2019 10:15:00 +0530 In a major health and wellness initiative for the country, the Union Cabinet chaired by the Prime Minister Narendra Modi has approved the Promulgation of the Prohibition of Electronic Cigarettes (production, manufacture, import, export, transport, sale, distribution, storage and advertisement) Ordinance, 2019. Electronic-cigarettes are battery-operated devices that produce aerosol by heating a solution containing nicotine, which is the addictive substance in combustible cigarettes. These include all forms of Electronic Nicotine Delivery Systems, Heat Not Burn Products, e-Hookah and the like devices. These novel products come with attractive appearances and multiple flavours and their use has increased exponentially and has acquired epidemic proportions in developed countries, especially among youth and children. Implementation: Upon promulgation of the Ordinance, any production, manufacturing, import, export, transport, sale (including online sale), distribution or advertisement (including online advertisement) of e-cigarettes shall be a cognizable offence punishable with an imprisonment of up to one year or fine up to Rs. 1 lakh or both for the first offence; and imprisonment of up to three years and fine up to Rs. 5 lakh for a subsequent offence. Storage of electronic-cigarettes shall also be punishable with an imprisonment up to 6 months or fine up to Rs 50,000 or both.   The owners of existing stocks of e-cigarettes on the date of commencement of the Ordinance will have to declare and deposit these stocks with the nearest police station. The Sub-Inspector of Police has been designated as the Authorized Officer to take action under the Ordinance. The Central or State Governments may also designate any other equivalent officer(s) as Authorized Officer for enforcement of the provisions of the Ordinance. The decision to prohibit e-cigarettes will help protect population, especially the youth and children, from the risk of addiction through E-cigarettes. Enforcement of the Ordinance will complement government's efforts for tobacco control and will help in reduction of tobacco use and reduction in associated economic and disease burden.   Industry Reactions: Smoking is the modern malady of modern mankind that has killed innumerable young and worthy souls. To combat that e-cigarettes were invented as a certified measure to wean smokers out from this bad habit. Unfortunately, e-cigarettes have done the opposite, bringing in the onset of diseases Lung cancer, Stomach cancer, Bladder cancer, Esophageal cancer, Heart disease and respiratory diseases like emphysema, which causes difficulty breathing. Hence, the Union Cabinet’s ban of e-cigarettes has been a welcoming move. With the increasing cases of NCDs, we need to take all preventive measures before it gets too late. There are alternative ways such as naturopathy, yoga & breathing exercises which can help combat the addiction. Savitha Kuttan, CEO, Omnicuris, social media enterprise which works for improving the quality of healthcare in India   Smoking is a conduit of death, killing more than 10 million people in an abundant nation like India. Our 2030 goal for complete health is getting hampered due to such diminishing mortality rate, creating a bigger snag for a prosperous India. The youth is swayed into picking up smoking due to its rampancy in both personal and professional sphere. Hence, the introduction of e-cigarette was initially heralded as a welcoming move to wean out this habit.  Naturally, when the govt has decided to ban e-cigarette it comes with mixed sentiments as although it helps chain smokers help get away from addiction yet one can often fall into a trap of using it as a tool of dependence. Dr G Prakash, Deputy CMO, Jindal Naturecure Institute   The recent vaping related deaths in the US have once again put a question mark over the possible toxity of chemicals present in e cigarette. While investigation into those deaths have still not been conclusive and point to a possibility of spurious products, we must refrain from looking at e cigarettes as a safe alternative. There have been longstanding doubts over what manufacturers and some health experts call “relative safety” of e cigarettes over tobacco cigarettes. We do not have sufficient research to understand the long-term health effects of e cigarettes. There is no ‘good smoke’ and all forms of smoke are bad. The major difference between conventional and e-cigarettes is that the latter do not contain tobacco. However, tobacco is not the only culprit in a cigarette smoke; there is an entire array of other harmful chemicals, many of which are also present in e cigarettes. This is why the approach to present e cigarettes as a “safer” option is highly flawed. It tends to normalize smoking in this form. Many people continue vaping believing it to be less harmful. Besides the presence of nicotine makes e cigarettes equally addictive, and many youngsters who have never smokes may fall for this form of smoking believing it to be safe. In this light, we welcome the government’s expected move to ban e cigarettes and According to a draft ordinance, the storage of e-cigarettes shall now also be punishable with imprisonment up to six months or fine upto Rs 50,000 or both.We must eliminate smoke and tobacco in all forms to be able to lay the foundation of a healthier India.     Dr. Dharminder Nagar,M.D Paras Healthcare   Electronic cigarettes contain nicotine, solvents, and other chemical agents. Nicotine itself is not carcinogenic. Tobacco smoke, on the other hand, contains many other chemicals that are carcinogenic. E-cigarettes have nicotine and inhaling it can increase heart rate, raise your blood pressure, and lead to sudden cardiac events in rare cases. Solvents are the other major component in E-cigarettes. There are many brands of E-cigarettes that contain solvents that are carcinogenic and there is no quality check on their contents. People who want to quit smoking have to understand that e-cigarettes are just a stopgap mechanism, and a dangerous one. Most importantly, people can get addicted to e-cigarettes as well, and a ban on their sale is a sensible move by the government. Rajesh Ranjan Singh, COO - WISH (Wadhwani Institute for Sustainable Healthcare)       ]]> https://biospectrumindia.com/news/22/14705/industry-an-important-pillar-for-growth-of-the-healthcare-sector-sadananda-gowda-.html https://biospectrumindia.com/news/22/14705/industry-an-important-pillar-for-growth-of-the-healthcare-sector-sadananda-gowda-.html Wed, 18 Sep 2019 16:55:00 +0530 PHD Chamber in association with Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers and Department of Biotechnology recently organized 6th PharmaMed HD 2019. The objective of the summit was to discuss on Transforming the Perception of Indian HealthCare Industry. The dignitaries present at the event deliberated about India as an emerging sector in the healthcare destination and how industry is looking forward to contribute more significantly to the healthcare delivery in the country as well as across the globe. Dr D K Aggarwal, Sr. Vice President, PHD Chamber of Commerce and Industry said, “There is a significant scope for enhancing healthcare services considering the major impetus of government on Healthcare for all. He said that rural India accounts for over 70 per cent of the population and is set to emerge as a potential demand source for the industry.” While inaugurating PharmaMed, D. V. Sadananda Gowda, Minister of Chemicals & Fertilizers said, “Indian industry can give a big push to the growth of healthcare sector in the country. Industry an important pillar for growth of the healthcare sector and millions of jobs to be created. He further emphasized that the thrust of the government is on facilitation to the industry to ensure the best healthcare delivery to the citizens for making India- a global leader in quality healthcare. “The sector is expected to generate employment for millions people by 2020. He added that the government is taking several initiatives such as 100% FDI for pharma sector, Greenfield investment opportunity, flagship schemes such as Ayushman Bharat and Pradhan Mantri Jan Aushadhi Yojana and setting up of R&D centres to give a boost to the sector”, he added. Sudhansh Pant, Joint Secretary, Ministry of Health & Family Welfare; Dr T S Kler, Chairman (Hospitals), Health Committee, PHD Chamber & Chairman, PSRI Hospital; Prof Bejon Misra, Chairman, Public Health Committee, PHD Chamber & Founder, Patient Safety and Access Initiative of India Foundation; Dr V G Somani, DCGI, CDSCO and Bhargav Kotadia, Managing Director, Sahajanand Medical Technologies were also the part of the event.   ]]> https://biospectrumindia.com/news/22/14695/ayushman-bharat-to-be-a-game-changer-in-providing-uhc-dr-harsh-vardhan-.html https://biospectrumindia.com/news/22/14695/ayushman-bharat-to-be-a-game-changer-in-providing-uhc-dr-harsh-vardhan-.html Wed, 18 Sep 2019 10:45:00 +0530 “The Ayushman Bharat journey which began on 14th April 2018 with the inaugural of a HWC at Jangla, a remote place in Chattisgarh, culminated in the launch of the second pillar of Ayushman Bharat- the Pradhan Mantri Jan Arogya Yojana (PMJAY) on 23 Sept, 2018 in Ranchi, Jharkhand.  I am happy to announce that in a short period of time, under the Ayushman Bharat scheme, more than 21,000 Health & Wellness Centres have become operational and about 47 lakh people have availed of treatments under its Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) pillar”. This was stated by Dr Harsh Vardhan, Union Minister of Health & Family Welfare, as he addressed the media announcing the launch of the Ayushman Bharat Pakhwara, a fortnight of enhancing awareness about the Yojana, the salient features of its twin pillars, and the benefits that can be availed of. He added that “This year, as we complete one year of launch of AB-PMJAY, we are celebrating Ayushman Bharat Pakhwara (15th-30th September), a fortnight-long national campaign to enhance awareness around the preventive, promotive and curative aspects of health care, nutrition, yoga and healthy lifestyle through Ayushman Bharat and other related initiatives such as Poshan Abhiyaan and Swachhta Abhiyaan. Dr Harsh Vardhan further stated that the flagship scheme of the Government, Ayushman Bharat is the vision of the Hon. Prime Minister Shri Narendra Modi ji to provide universal health care to the poor, needy and vulnerable sections of the country, who most need it. A path-breaking approach and a game-changer, it is probably the biggest public healthcare initiative in the world.” While the 1.5 lakh Health & Wellness Centres (to be operationalised by Dec 2022) provide comprehensive primary care (CPHC) including preventive and promotive healthcare close to the communities, PMJAY covers 50 crore poor and vulnerable people in the country. It provides a health assurance cover of Rs. 5 lakh per family per year for secondary and tertiary care for serious and catastrophic illnesses, he elaborated. PM-JAY provides cashless and paperless access to services for the beneficiary at the point of service. Through more than 21,000 AB-HWCs, the service area population (around 5 crore population empanelled to these centres) are getting out patient service besides the assured maternal and child healthcare services and management of common ailments through newly posted, trained and appropriately oriented Community Health Officers (CHOs). The operational AB-HWCs have a footfall of 1,70,63,522 patients till date. “AB-HWCs will help to provide an enabling environment to increase the health seeking behaviour of the poor people; contribute towards reducing the out of pocket expenditure of the common people; create an assured system of continuum of care model (well-defined referral chain); help in increasing the trust of the people on the service provision by public healthcare facilities through health system strengthening and improvement; and enhance awareness to the people on preventive and promotive healthcare, yoga, healthy lifestyle and Eat Right & Eat SAFE etc.”, he added Further elaborating on the benefits that have accrued from the AB-HWCs, the Health Minister stated that more than 1.5 Crore population is screened for hypertension and more than 70 lakhs people are put on treatment; similarly, around 1.3 crore population are screened for Diabetes and more than 31 lakhs people are on treatment. Similarly, for suspected cases for the three common cancers (breast, cervix and oral), they are referred to the higher public healthcare facilities for diagnosis and treatment. He added that more than 76 lakhs population is screened for oral cavity cancer and out of these, 10,218 people are on treatment.  While more than 53 lakhs women is screened for breast cancer and around 9700 women are on treatment, more than 37 lakhs women is screened for cervical cancer and around 10000 women are on treatment. In addition, more than 1.6 Crores have been provided medicines and around 49 lakhs population are provided diagnostic services. Dr Harsh Vardhan also informed that tele-consultation services to the people with the qualified medical officers and specialists for cases referred from Sub Health centre level and PHC level respectively will be introduced shortly. A pilot is being done with eSanjeevani application of C-DAC, Mohali in Gujarat; after the due security audit, it will be rolled out in all functional AB-HWCs in phased manner. The Health Minister further stated that since the launch of PMJAY on 23rd Sept last year by the Hon. Prime Minister, more than 47 lakh hospital treatments worth over Rs 7,500 crore have been carried out. Of the total amount utilised, 55% has been on tertiary procedures. In addition, more than 10 crore beneficiary cards have been issued. As on date, 32 States and Union Territories are implementing the PMJAY. Minister further stated that under AB-PMJAY, 18,073 hospitals and health care providers have been empanelled across the country. Of this, 53% of the hospitals empanelled are private, especially multi-speciality, and 62% of the treatments have been in these private hospitals. A unique feature of PMJAY is its portability, which has helped the eligible poor and migrant workers to seek treatment outside their states. So far, there have been more than 40,000 portability cases, he informed. Dr Harsh Vardhan added that “Through its vision and design, we have been able to bring on board nearly all States and Union Territories and get whole-hearted political and administrative support for it. This is a demonstration of our commitment to the highest ideals of cooperative federalism”. The Health Minister added that recently the Governing Board of the National Health Authority decided to overhaul the existing health benefits packages and rationalize the cost of the packages to remove any aberrations. “This will ensure wider private sector participation by empanelling more hospitals to improve access to hospitalization related care. We also approved an upgrade to our IT system to make it even more user-friendly, interoperable, secure and state-of-the-art, he stated. Initiatives for improving the quality of services were also endorsed”, Dr Harsh Vardhan said. Dr Harsh Vardhan said that a strong fraud prevention, detection and control system is proving to be critical for PM-JAY, to ensure that frauds are largely prevented and even if they are attempted, they are quickly detected and strong action is taken. Due to the policy of zero tolerance towards corruption, 97 errant hospitals have been de-empanelled and penalties worth more than Rs.1.5 crore have been levied. Besides providing good healthcare services, the scheme is also progressing to achieve its vision of increasing employment in the health sector. He stated that an indigenous healthcare setup is coming up across India, and the infrastructure will develop further, especially in tier II and tier III towns. In the last one year, the scheme has started to create thousands of jobs across the healthcare sector in India, and many more will be created in the coming years. The Union health Minister also stated that to mark the first year anniversary of PMJAY, the National Health Authority is organizing a 2-day national workshop, Arogya Manthan, on September 30th and October 1st, 2019. In the Arogya Manthan, all important stakeholders of PM-JAY will meet and discuss through day-long sessions and working groups to come up with implementable solutions to the challenges faced in the past year in the implementation of the scheme and to forge new understanding and pathways towards improving implementation. ]]> https://biospectrumindia.com/news/22/14671/nha-irdai-focus-on-transforming-health-insurance-ecosystem.html https://biospectrumindia.com/news/22/14671/nha-irdai-focus-on-transforming-health-insurance-ecosystem.html Mon, 16 Sep 2019 11:30:00 +0530 National Health Authority (NHA) and Insurance Regulatory and Development Authority of India (IRDAI) have launched ‘four’ reports focussing on – Hospital Network Management, Common IT Infrastructure for Health Insurance Claims Management, Fraud & Abuse Control and on Data Standards & Exchange. The report was launched by Subhash Khuntia, Chairman IRDAI and Dr Indu Bhushan, CEO, National Health Authority. A Joint Working Group of IRDAI and NHA was formed to work on key areas of mutual interest and co-operation. The reports are a result of four sub-groups formed to work in-depth with diligence and focus on each area. These groups focussed their work on four key areas: Hospital Network Management: To build a National Repository of Empanelled Hospitals under insurance/Government schemes with defined standards for quality and package rates and codes by: Defining hospital infrastructure and facility audits to understand the capacity of hospitals and the availability of specialists Developing a roadmap to get one common list of accredited verified hospitals for the entire industry including ROHINl, NHRR, NIN and PMJAY databases Comparative study of packages, their rates and mapping to uniform codes Defining Standards and indicators for safe and quality Healthcare to Patients Data Standardization and exchange: To create standard data formats across Health insurance payers for analysis and policy-making by: Developing standardised data tables to capture and report the data, identifying data elements common with IRDAI and PMJAY Setting up a framework for capturing and exchanging data Fraud and abuse control: To help detect and deter frauds through common repository and capacity building by: Developing a standard reporting format for fraud and abuse to be used across the industry and Govt. Schemes Making a repository of fraudulent transactions, modus operandi and entities Develop standards for field verification and investigation Develop the "name and shame" guidelines Common IT infrastructure for health insurance claims management: To increase service efficiency and transparency amongst stakeholders in the delivery of Health insurance services by Defining the roadmap for electronic, paperless, codified data exchange between payer and provider, collation and analysis Defining a roadmap for the creation of standard electronic personal health record for the insured population with a common identifier   Sixty per cent of the Indian population today is covered under Ayushman Bharat Pradhan Mantri Jan Arogya Yojana and privately paid health insurance making it a great opportunity for IRDAI and NHA to jointly work on key areas for the strengthening of health insurance eco-system in the country, making it more efficient and effective. Dr Indu Bhushan also expressed great satisfaction at work done by JWG and said, “The recommendations in the report are a step forward in enabling quality healthcare and access to the patients. These reports would help further strengthen the transparency, efficiency and effectiveness of AB-PM-JAY, benefitting millions in India directly.” Speaking on occasion, Subhash Khuntia, Chairman IRDAI said, “The completion of these report in record time is a huge achievement, and I thank the members of the Joint Working Group who have toiled to put them together.  We are confident that implementation of these recommendations shall create a positive impact and lead to further growth of health insurance in the country.” The recommendations in the report include best practices, common standards, collaborative measures and IT framework, will benefit all stakeholders – beneficiaries, policyholders, insurers, state health agencies, healthcare providers, implementing agencies and intermediaries etc. The Reports of Joint Working Group shall be available on IRDAI and NHA website for comments by industry and public at large.    ]]> https://biospectrumindia.com/news/22/14594/health-minister-reiterates-commitment-to-fight-tb-hiv-malaria.html https://biospectrumindia.com/news/22/14594/health-minister-reiterates-commitment-to-fight-tb-hiv-malaria.html Wed, 04 Sep 2019 11:10:00 +0530 “Under the visionary and dynamic leadership of the Prime Minister Narendra Modi, India has announced a contribution of $22 million to the Global Fund for AIDS, TB and Malaria (GFTAM) for the 6th replenishment cycle (2020-22), an increase of 10% over the amount contributed by us in the 5th cycle. Dr Harsh Vardhan, Union Minister for Health and Family Welfare stated that “India stands firm to its long-standing partnership with the Global Fund and its commitment to eliminate AIDS, Tuberculosis and Malaria”. India’s pledge for the Global Fund strongly demonstratesitsstrong political leadership to achieve the universal health for all and its equallystrong commitment to work across borders to join hands in fighting the epidemics of these three diseases”. Dr Harsh Vardhan highlighted that India was the first implementing country to host a replenishment milestone of the Global Fund and now has become first among G20, BRICS and implementer countries to announce the pledge for the 6th Replenishment Conference, setting precedent for other donors to contribute generously for the cause.  He said that we are adequately financing our efforts to accomplish our goals of TB, HIV and Malaria elimination and with our increased pledge, India has inched a step closer in this direction by stepping up the Global Fund efforts to strengthen health systems and save 16 million more lives across the globe. Partnership between India and Global Fund India shares a sustained partnership with the Global Fund since 2002 both as recipient and as a donor. Global Fund support with investment of $ 2.0 billion so far has made significant contribution in attaining targets related to HIV/AIDS, TB and Malaria reduction and escalating our fight against these three diseases. In the current funding cycle (2018-21), the Global Fund has allocated $ 500 million to India. As a donor, India has contributed $ 46.5 million so far till 2019 including US$ 20 million for the 5th Replenishment. ]]> https://biospectrumindia.com/news/22/14575/health-ministry-to-explore-ai-based-solutions-in-combating-tb.html https://biospectrumindia.com/news/22/14575/health-ministry-to-explore-ai-based-solutions-in-combating-tb.html Mon, 02 Sep 2019 09:00:00 +0530 The Central TB Division of the Health Ministry has signed a Memorandum of Understanding (MoU) with Wadhwani Institute for Artificial Intelligence to explore the application of cutting-edge Artificial Intelligence technology in its fight against TB. The MoU was signed by Vikas Sheel, Joint Secretary (HFW) and Dr P Anandan, CEO (Wadhwani AI). As part of the collaboration, Wadhwani AI would be supporting National TB programme become AI-ready which would include, developing, piloting, and deploying AI-based solutions. It would support the programme in vulnerability and hot-spot mapping, modelling novel methods of screening and diagnostics and enabling decision support for care-givers apart from supporting the RNTCP in adoption of other AI technologies. The Revised National TB Control Programme has been at the forefront of adoption of newer technologies in healthcare. Artificial Intelligence (AI) provides a unique opportunity for the health sector, bringing efficiency, saving resources and bringing accuracy in interpretation and enhancing quality of service delivery. Its use in this sector has an ample scope to improve outcomes, especially in situations where resources are limited. India is committed to ending TB by 2025, five years ahead of the Global Sustainable Development targets.     ]]> https://biospectrumindia.com/news/22/14572/cabinet-approves-agreement-between-india-and-peru-in-the-field-of-medicinal-plants.html https://biospectrumindia.com/news/22/14572/cabinet-approves-agreement-between-india-and-peru-in-the-field-of-medicinal-plants.html Thu, 29 Aug 2019 16:55:00 +0530 The Union Cabinet, chaired by the Prime Minister Narendra Modi has approved signing of agreement between the National Medicinal Plants Board, Ministry of AYUSH of the Republic of India and the National Institute of Health of the Ministry of Health of the Republic of Peru on Cooperation in the field of Medicinal Plants. Major impact: Considering the fact that both countries having rich medicinal plants biodiversity and medicinal plants based indigenous traditional system of medicines and recognizing the existing friendly and cooperative relations, the proposed Agreement will further enhance bilateral cooperation between the two countries in the area of Medicinal Plants. This will be of immense importance to both countries. This Agreement will provide structured framework for cooperation between the two countries on Medicinal Plants. Implementation strategy and targets: The activities between the two Parties will start immediately after signing of the Agreement. The initiatives taken by the two countries will be in accordance with the terms of reference of the Agreement and will continue till the Agreement remains in operation. Expenditure involved: There is no additional financial implication involved. The financial resources necessary to conduct research, training courses, conferences / meetings will be met from the existing allocated budget and existing plan schemes of the National Medicinal Plants Board, Ministry of AYUSH. India is one of the richest countries in the world in terms of biodiversity and more than 7000 species of plants are estimated to have medicinal usage in folk and documented systems of traditional medicines like Ayurveda, Unani, Siddha & Homoeopathy (AYUSH System of Medicine). The Republic of Peru is one of the Latin American Countries which are the biodiversity hotspots in the world and like India, Peru is also having rich biodiversity of medicinal plants and the medicinal plants based traditional medicine practices are prominently practiced by indigenous people. Considering the richness of medicinal plants biodiversity and uses of these resources in Indigenous Traditional Systems of medicines in both countries and to strengthen the bilateral cooperation, the proposed Agreement on cooperation, in the field of medicinal plants is envisaged.   ]]> https://biospectrumindia.com/news/22/14559/cabinet-approves-mou-with-guinea-gambia-on-traditional-medicines.html https://biospectrumindia.com/news/22/14559/cabinet-approves-mou-with-guinea-gambia-on-traditional-medicines.html Wed, 28 Aug 2019 21:50:00 +0530 The Union Cabinet chaired by the Prime Minister Narendra Modi has given ex-post facto approval to the Memorandums of Understanding (MoU) between India and Gambia in the Field of Traditional Systems of Medicine; and between India and Guinea on Cooperation in the Field of Traditional Systems of Medicine and Homeopathy. The MoU will provide a framework for cooperation between the countries for the promotion of traditional systems of medicine and will mutually benefit the countries in this field. Activities mentioned in the MoU will boost the importance of AYUSH Systems of Medicine in Gambia and Guinea. As a consequence of the MoU, exchange of experts for training of the practitioners, and Scientists undertaking collaborative research in Traditional Systems of Medicine are expected to lead to new innovations in drug development and practice of Traditional Medicine. ]]> https://biospectrumindia.com/news/22/14553/union-minister-launches-mobile-app-for-generic-medicines.html https://biospectrumindia.com/news/22/14553/union-minister-launches-mobile-app-for-generic-medicines.html Wed, 28 Aug 2019 10:50:00 +0530 Union Minister for Chemicals and Fertilizers, D.V. Sadananda Gowda has launched a mobile application “Janaushadhi Sugam” and has announced that “Jan Aushadhi Suvidha Oxo-Biodegradable Sanitary Napkin” will now be available at only One Rupee per pad. Minister of State for Shipping (IC) and Chemicals & Fertilizers, Mansukh L. Mandaviya also graced the launch event held in New Delhi. Making the announcement on the Jan Aushadhi Suvidha Oxo-Biodegradable Sanitary Napkins, Gowda said that the assurance by the Prime Minister Narendra Modi on this aspect about a year ago has been fulfilled now. He said that the “Janaushadhi Sugam” will enable people to search Janaushadhi generic medicines and the stores at the tip of their fingers. Mandaviya said that it is that about 28 million girls are reported to be leaving education because of lack of availability of good quality Sanitary Napkin” pads at reasonable cost. He said, Department of Pharmaceuticals is determined to provide affordable healthcare to all Indians through ever-increasing network of PMBJP Kendras across countryand this had already led to substantial savings to poor on medicines. The Government of India launched “Jan Aushadhi Suvidha Oxo-Biodegradable Sanitary Napkin” at Rs 2.50 per pad on the eve of the World Environment Day 4thJune 2018. Jan Aushadhi Suvidha comes with a special additive, which makes it biodegradable when it comes in contact with oxygen after being discarded. Till 31stJuly 2019, over 1.30 crore pads were sold at Pradhan Mantri Bhartiya Janaushadhi Kendras. In order to make these sanitary pads more affordable and accessible to the women of India, Government of India has now decided to make these pads available at rate of only Rs 1.00/- per pad as promised by the Prime Minister before the ‘Lok Sabha Election-2019’. This is an important step in ensuring the health security forthe section of Indian women who still use unhygienic aids during menstrual period due to non-affordability of sanitary pads available in themarket. This will ensure ‘Swachhta, Swasthya and Suvidha’ for the underprivileged women of the country. This step taken by the Department of Pharmaceuticals will ensure the achievement of Prime Minister Shri Narendra Modi’s vision of “Affordable and Quality Healthcare” for all. It will also help in fulfilling the Prime Minister’s dream of “Clean India & Green India” as these pads are oxo-biodegradable and environment friendly. Jan Aushadhi Suvidha is beingmade available for sale in more than 5500 PMBJP Kendras across the country. “Janaushadhi Sugam” mobile application would have user-friendly options like- to locate nearby Janaushadhikendra, direction guidance for location of the Janaushadhikendra through Google Map, search Janaushadhi generic medicines, analyse product comparison of Generic vs Branded medicine in form of MRP & overall Savings, etc. The mobile application is available on both Android & iOS platforms. It can be downloaded free of cost by the user from Google Play Store and Apple Store. ]]> https://biospectrumindia.com/news/22/14534/health-ministry-to-enhance-outreach-on-hiv-aids-prevention.html https://biospectrumindia.com/news/22/14534/health-ministry-to-enhance-outreach-on-hiv-aids-prevention.html Tue, 27 Aug 2019 09:00:00 +0530 “As health is the responsibility of all Government departments, there is a need for a ‘sub-department of health’ in all the Ministries for health impact assessment of the policies/initiatives of these Ministries right from the conceptual stages.” This was stated by Dr Harsh Vardhan, Union Minister of Health and Family Welfare as he presided over the MoU signing ceremony between National AIDS Control Organisation (NACO), under Ministry of Health and Family Welfare, and Department of Social Justice and Empowerment (DoSJE) under Ministry of Social Justice & Empowerment (MoSJE). Ashwini Kumar Choubey Minister of State (HFW) and Rattan Lal Kataria, Minister of State (DoSJE) along with Preeti Sudan, Secretary (HFW) and Nilam Sawhney, Secretary (DoSJE) were also present at the MoU signing ceremony. The MoU was signed by Sanjeeva Kumar, Special Secretary & Director General (NACO & RNTCP) and Upma Srivastava, Additional Secretary (DoSJE). This is the 18th such MoU with other Government departments/ Ministries. Emphasizing on the need for innovations and newer ideas and thoughts for taking forward the fight against HIV/AIDS, Dr Harsh Vardhan stated that good quality knowledge and widespread awareness campaigns about the disease have immensely contributed to combatting it. Dr Harsh Vardhan said that this is the age of innovations and ideas and the kind of results we are expecting cannot be achieved through routine activities. “Some of the brightest ideas have come from the grassroots and it is therefore pertinent that we involve the grassroots people in all our strategy deliberations through regular brainstorming,” he stressed. He urged for synergies and alliances to be forged with various stakeholders in order to learn from their best practices. Appreciating NACO for its notable achievements, Dr Harsh Vardhan stated that it is indeed commendable that NACO has worked with some of the most vulnerable people. It has played a very big role in significantly reducing the prevalence of HIV/AIDS in the country, and that too faster than the global rates.  He added that the impact of the programme has been significant with more than 80% decline in estimated new infections from peak of epidemic in 1995. “Similarly, estimated AIDS related death declined by 71% since its peak in 2005. As per UNAIDS 2018 report, the global average for decline in new infections and AIDS related deaths from peak has been 47% and 51% respectively,” Dr Harsh Vardhan mentioned. He further said that the Government is fully committed for meeting all the set goals to eliminate HIV/AIDS by 2030. Dr Harsh Vardhan further said that this is one of the most important MoUs. It will help in developing specific strategies and action plans for HIV and AIDS prevention and mechanisms for drug addiction treatment and extending social protection schemes to the vulnerable populations. Speaking on the key deliverables of the MoU, he stated that the MoU will help in developing human resources and build capacity in order to strengthen the service delivery mechanisms for HIV & AIDS prevention, drug addiction treatment and referral to services offered by National AIDS Control Programme and DoSJE. The Union Health Minister further said that it aims at reducing incidence of social stigma and discrimination against victims of drug abuse and Children and People Living with HIV/AIDS. “It aims to promote enabling environment based on no stigma and discrimination,” Dr Harsh Vardhan added. Ashwini Kumar Choubey, MoS (HFW) said that MOUs with other Ministries are low investment and high impact initiatives that help in leveraging each other’s strength. He emphasised on enhancing awareness of the target population. Rattan Lal Kataria, MoS (DoSJE) said that the MoU will help in reaching out to the marginalised groups and will provide opportunity for empowerment and access to social protection schemes by the high risk population, persons engaged in begging, People Living with HIV/AIDS (PLHIV), and Children affected by HIV & AIDS (CABA). The Minister also appreciated MoHFW for its initiatives. The MOU will catalyze in achieving the national goals and objectives of HIV prevention and impact mitigation. Through this MoU, the services of various institutes under DoSJE such as National Centre for Drug Abuse Prevention (NCDAP), National Institute of Social Defence (NISD), Integration Rehabilitation Centres for Addicts (IRCAs) will be leveraged for execution of activities laid out in the MoU. ]]> https://biospectrumindia.com/news/22/14499/niti-aayog-puts-focus-on-successful-ppp-in-healthcare.html https://biospectrumindia.com/news/22/14499/niti-aayog-puts-focus-on-successful-ppp-in-healthcare.html Thu, 22 Aug 2019 10:00:00 +0530 Dr VK Paul, Member (Health), NITI Aayog, Government of India has stated that the public and private sectors in the healthcare sector have come together and are fully committed to serve the people of India, speaking at 'FICCI HEAL 2019 - Health of Healthcare in India',  organised by FICCI supported by NITI Aayog and National Health Authority. "Most important highlight of Ayushman Bharat is that it has now finally established 'One India, one nation, one health sector'. Private-public demarcations are over once and for all. We are working together on agreed terms and methodologies through dialogue and systems with an endeavour to find solutions to the challenges of our healthcare system" he said. Dr Paul said that over the last year, country has added 25% additional MBBS seats, which is unprecedented. "From about 60,000 MBBS seats last year, this year we have about 76,000 seats and actually a potential of about 80,000 seats," he said. He also said that strengthening human resources for the health sector is the key focus of the government, for which it does not differentiate between public and private sectors. The government is working to establish 75 additional medical colleges in the next 4-5 years largely through PPP models for district hospitals and other mechanisms. This is in addition to the creation of 82 medical colleges that began 5 years ago. "The emphasis on human resources in this government is profound. If you consider Ayushman Bharat to be the highlight of the Independence Day speech of Prime Minister last year, this year for the health sector he only spoke about human resources, which has gained centrality in the development agenda of the nation," he added. Dr Paul further said that with the reforms in the health sector, a consortium of private players can now set up a medical college unlike in the past when a medical college had to be established by a single entity. He urged the private sector to use their resources for training specialists to help achieve the aspired numbers. Ms Sangita Reddy, Senior Vice President, FICCI and Joint MD, Apollo Hospitals Enterprise Ltd said, "Ayushman Bharat is transformational for the country. Now we need to up the dialogue on healthcare further and converge the power of Ayushman Bharat with the viability for the sector to make quality healthcare sustainable." Mr YS Chi, Chairman, Elsevier, RELX Group said that health records, digital doctor and medical research are the three key tenets that will drive reforms in the Indian healthcare sector. Future medicine will require close coordination between augmented intelligence and doctors, he added. Dr Arvind Lal, Chair, FICCI Health Services Committee and CMD, Dr Lal Pathlabs said, "As the country aims to become a $ 5 Trillion economy, healthcare industry will play a major part in building a prosperous & a healthy India." He added that "fund allocation to the North Eastern states has shot up by almost 250% over the last 5 years. Imagine if this was to happen in health care. We urge the government to increase the public health spend to at least 2.5%, as envisaged in the National Health Policy 2017, and preferably to 3%, at the earliest." FICCI-EY knowledge paper on 'Re-engineering Indian Healthcare 2.0' and FICCI-ELICIT information guides to 'Facilitate execution of End of Life Decisions' were released during the event.  The 'Re-engineering Indian Healthcare 2.0' study recommends a 5E framework comprising integrating empathy, efficiency, empowerment, ease and environment to build trust. 'Empathy' in fostering patient dignity through transparency and communication, especially in financial matters related to billing. 'Efficiency' to improve the planning and execution of key care delivery processes to reduce waiting times and improve responsiveness. 'Empowerment' by providing relevant and accurate information to patients which can also be easily accessed. 'Ease' by delivering healthcare facilities at different locations or third places apart from hospitals and homes. 'Environment' by facilitating a physical healing space for patients.   ]]> https://biospectrumindia.com/news/22/14489/dbt-requests-for-proposals-for-strengthening-clinical-trial-capacity.html https://biospectrumindia.com/news/22/14489/dbt-requests-for-proposals-for-strengthening-clinical-trial-capacity.html Wed, 21 Aug 2019 11:05:00 +0530 The Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India, has announced the request for proposals (RFP) for establishing Clinical Trial Networks and Strengthening Clinical Trial Capacity, under the National Biopharma Mission. The programme is being funded by DBT along with World Bank Loan Assistance (Innovate in India for Inclusiveness Project or i3). The vision of the Program is to enable and nurture an ecosystem for preparing India’s technological and product development capabilities in biopharmaceuticals including vaccines, biologics, medical devices and diagnostics to a level that will be globally competitive overthe next decade. Through this RFP, NBM proposes to establish Clinical Trial Networks (CTNs) and Strengthen Clinical trial capacity The request includes proposals- RFP1- To establish Clinical Trial Networks (CTNs) for hospital-based trial in specialties of Diabetology, Ophthalmology, Rheumatology and Oncology. RFP 2: To study epidemiology of Dengue & Chikungunya in different age-groups at existing DSS/DHS/DDESS sites (Demographic Surveillance System / Demographic and Health Surveillance / Demographic, Development and Environmental Surveillance System)  and to further prepare the sites for conduct of GCP compliant field-based clinical trials. RFP 3: Establish new DSS/DHS/DDESS sites within the country to have complete geographical representation of potential trial sites and to study epidemiology of Dengue & Chikungunya in different age-groups at these sites. RFP 4: To Establish data management platform: An IT platform for community-based data collection, analysis and reporting.   The proposals can be submitted: Solely by Non-profit organizations / Societies / Trusts/ Foundation/ Associations/ Government entities/ Institutes/ Institutes established under Acts/statute OR Jointly by Non-profit organizations / Societies / Trusts/ Foundation/ Associations/ Government entities/ R&D Organizations / Institutes established under Acts. ]]> https://biospectrumindia.com/news/22/14421/health-minister-draws-attention-towards-rotavirus-vaccine.html https://biospectrumindia.com/news/22/14421/health-minister-draws-attention-towards-rotavirus-vaccine.html Sat, 10 Aug 2019 10:10:00 +0530 “The Health Ministry has drawn an ambitious plan under the 100-days agenda of the newly elected government, wherein it has been decided to provide Rotavirus vaccine to every child across all 36 states and UTs by September, 2019.” This was stated by Dr Harsh Vardhan, Union Minister of Health and Family Welfare while speaking on the expansion of Rotavirus vaccine to the entire country. The Union Health Minister further added that the Government is committed to ending morbidity and mortality in children due to diarrhoea by 2022. Strengthening routine immunization is an essential investment in India’s children and will ensure a healthy future of the country, he stressed. Dr Harsh Vardhan further said that Diarrhoea is one of the biggest killers in children and Rotavirus is one of the most common causes of severe diarrhoea in children less than 2 years of age. “Rotavirus vaccine along with proper sanitation, hand washing practices, ORS and zinc supplementation will go a long way in reducing the mortality and morbidity due to diarrhoea in children,” he mentioned. The Union Health Minister further added that the Government is also committed to increasing the full immunization coverage and ensuring that the benefit of the life-saving vaccines is provided to every child. Dr Harsh Vardhan said that no child in the country should die from Vaccine Preventable Diseases and it is the ‘Goal and Commitment of our government’. “We stand committed to reducing child deaths and provide a healthier future to our children and the expansion of Rotavirus vaccine under UIP is a step in that direction”, he added. In India, every year 37 out of every 1000 children born are unable to celebrate their 5th birthday, and one of the major reasons for this is diarrheal deaths. Out of all the causes of diarrhoea, rotavirus is a leading cause of diarrhoea in children less than 5 years of age. It is estimated that rotavirus cause 8,72,000 hospitalizations; 32,70,000 outpatient visits and estimated 78,000 deaths annually in India. Rotavirus diarrhoea presents in similar manner like any other diarrhoea but can mainly be prevented through rotavirus vaccination. Other diarrhoea can be prevented through general measures like good hygiene, frequent hand washing, safe water and safe food consumption, exclusive breastfeeding and vitamin A supplementation. Keeping in view the burden of disease which can be prevented through vaccination, National Technical Advisory Group on Immunization (NTAGI), an expert committee, recommended introduction of rotavirus vaccine (RVV) in the Universal Immunization Programme (UIP). Three doses of rotavirus vaccine are provided along with other vaccines, free of cost under UIP at one and half month, two and half moth, and three and half month of age of child. Rotavirus vaccine was introduced in 2016 in a phased manner, beginning with 4 states initially and later expanded to 7 more states making it a total of 11 states by end of 2018, where Rotavirus vaccine was available in the country. At present the vaccine has been further expanded to 17 more states till now. Rotavirus vaccine is now available in 28 States/UTs, namely, Andhra Pradesh, Haryana, Himachal Pradesh, Jharkhand, Odisha, Assam, Tripura, Rajasthan, Tamil Nadu, Madhya Pradesh, Uttar Pradesh, Manipur, Daman & Diu, Gujarat, Bihar, Sikkim, Arunachal Pradesh, Chhattisgarh, Maharashtra, Dadra & Nagar Haveli, Goa, Chandigarh, Nagaland, Delhi, Mizoram, Punjab, Uttarakhand, and Andaman and Nicobar Islands. ]]> https://biospectrumindia.com/news/22/14311/icmr-launches-national-data-quality-forum.html https://biospectrumindia.com/news/22/14311/icmr-launches-national-data-quality-forum.html Mon, 29 Jul 2019 12:15:00 +0530 The Indian Council of Medical Research (ICMR)’s National Institute for Medical Statistics (ICMR - NIMS), in partnership with Population Council, has launched the National Data Quality Forum (NDQF). The launch was attended by representatives from the government, academic institutions, technology and developmental partners who work towards strengthening the data ecosystem in the country.  NDQF will integrate learnings from scientific and evidence-based initiatives and guide actions through periodic workshops and conferences. Its activities will gear towards establishing protocols and good practices when dealing with data collection, storage, use and dissemination that can be applied to health and demographic data, as well as replicated across industries and sectors. “We are delighted to launch the National Data Quality Forum and embark upon a fruitful collaboration to generate meaningful dialogue around the improvement of data quality in general, and for health and medical research in particular,” said Prof. (Dr.) Balram Bhargava, Director General of the Indian Council of Medical Research. With a renewed emphasis on improving the quality of data that feeds into evidence based decision making at different levels, the NDQF hopes to bring together relevant stakeholders, subject matter experts, industry leaders, decision makers, and data scientists / analysts onto a common platform. This platform will be guided by the direction provided by a high level steering committee and operationalized with the help of a technical advisory group composed of subject matter experts. With a mandate to create a dialogue for data quality, and build a like-minded community of practice ]]> https://biospectrumindia.com/news/22/14287/nha-and-nathealth-to-drive-innovations-in-healthcare-sector.html https://biospectrumindia.com/news/22/14287/nha-and-nathealth-to-drive-innovations-in-healthcare-sector.html Fri, 26 Jul 2019 09:00:00 +0530 Highlighting the critical role of innovations in achieving the goal of Universal Health Coverage through programs like Ayushman Bharat–Pradhan Mantri Jan Arogya Yojana (PM-JAY), its implementing agency National Health Authority (NHA) has signed a Memorandum of Understanding (MoU) with apex healthcare industry body NATHEALTH- Healthcare Federation of India. The aim of this strategic partnership is to enable a seamless pathway that streamlines all innovations ensuring that it scales and increases the efficacy of PM-JAY service delivery. Further, this collaboration provides an industry interface for testing innovations; providing mentorship and creating channels for facilitating support required for scaling these innovations. This will bolster NHA’s effectiveness in implementing its innovation strategy, which is aligned with its vision of “Health for All”. NHA and NATHEALTH have jointly agreed to meet the following objectives through this MoU:  Identifying and curating the best healthcare innovations and start-ups from India.  Assessing healthcare innovations through varied perspectives such as clinical, technical, impact, sustainability and scalability.  Enabling an ecosystem for healthcare innovations to engage with Ayushman Bharat PM-JAY.  Enabling an ecosystem for the industry partners within the NATHEALTH network to participate in piloting, testing, adopting, funding and scaling innovations.  Providing Go-to-market support across Tier I, II and III cities, and rural areas.  Starting a dialogue on ‘how to create an enabling regulatory framework for mainstreaming innovation’.   This initiative will focus on a variety of healthcare sectors, including but not limited to: Value-based healthcare Population health management, risk management and insurance administration Chronic secondary and tertiary ailments Digital health Medical Devices Health Data Analytics Technology-enabled models of healthcare delivery including leveraging innovations centered around frontier technologies Improving operational efficiency of service delivery of PM-JAY Speaking at the MoU signing, Dr. Indu Bhushan, CEO, National Health Authority, said “NHA enthusiastically looks forward to this partnership. With the implementation of Ayushman Bharat PM-JAY, it is paramount that we increase the efficacy of the health service delivery such that we can provide an increased access to high quality of care. We have been witnessing a plethora of healthcare innovations happening across the country and it is crucial to empower them by providing the right support. I am confident that this partnership will help us in linking PM-JAY, the industry and the innovators thus enabling increased adoption of numerous inventions, leading to an increase in access to quality care delivered under PM-JAY.” Airing his views on the scope of the partnership, Dr. H Sudarshan Ballal, President, NATHEALTH said, “We welcome this opportunity to work with NHA to build partnerships with innovators, who will help shape healthcare in India. The main objective of the joint Initiative is to provide and enable a healthcare innovation ecosystem that supports healthcare innovators and provides them opportunities to partner and scale. We will be assessing these innovations from all perspectives within industry and connected innovation landscape. This initiative also aims to enable healthcare innovations to access private industry support, funding from private capital and other funders, and mentorship from clinical, technology and business experts.” The partnership will aim to create open platforms such as universities, start-up incubators and accelerators, private industries, investors (private capital, grant-giving organizations and foundations) that will enable engagement between different types of innovation organizations.   ]]> https://biospectrumindia.com/news/22/14281/nbm-to-strengthen-technology-transfer-in-india.html https://biospectrumindia.com/news/22/14281/nbm-to-strengthen-technology-transfer-in-india.html Thu, 25 Jul 2019 11:30:00 +0530 Biotechnology Industry Research Assistance Council (BIRAC), Government of India, has announced  Technology Transfer and Commercialization Training-2019 Under National Biopharma Mission (NBM) of Department of Biotechnology (DBT). Through a series of planned technology transfer training programs, NBM intends to strengthen overall capacity in the country in technology transfer. The training programs planned will provide conceptual as well as applied learning experience to participants and progressively build required skills. This training program is tailored for professionals with applied exposure and for individuals with relevant education background in IP/Tech transfer who wish to pursue this as career path. To ensure healthy learning cohort for such an applied learning program, it is essential that the program has a balanced mix of participants. The selection criteria will include considerations on participant’s individual profile and to a limited extent the institutional engagement in translational research. Cohort size for each of the two programs planned will be about 25 to 30 participants. ]]> https://biospectrumindia.com/news/22/14258/fda-urges-to-submit-thorough-timely-safety-information-for-combination-medical-products.html https://biospectrumindia.com/news/22/14258/fda-urges-to-submit-thorough-timely-safety-information-for-combination-medical-products.html Tue, 23 Jul 2019 15:20:00 +0530 The U.S. Food and Drug Administration released a final guidance, "Postmarketing Safety Reporting for Combination Products," for applicants of combination products "In the past decade we have seen a marked increase in interest from manufacturers who seek to develop medical products that combine devices, drugs and/or biologics. While there are many variations of these combination products, some of the most innovative are being created to deliver the correct dose of a drug to a precise part of the body at set times. This can lead to more targeted treatments that ensure patients receive correct dosages without the need to remember to take their medicine at a precise time," said FDA Principal Deputy Commissioner Amy Abernethy, M.D. "But as this area has grown, so too has the need for information about the safety of these products when in routine use by patients. Today, the FDA is taking another step to help applicants better comply with important product postmarketing safety reporting requirements and provide us timely, comprehensive safety information about combination products at established intervals. We are issuing guidance, finalized today, that will help applicants better understand how to submit their combination product postmarketing safety reports. This guidance reinforces FDA's expectations for timely postmarketing safety information about combination products." The U.S. Food and Drug Administration released a final guidance, "Postmarketing Safety Reporting for Combination Products," for applicants of combination products—products composed of two or more different types of medical products (i.e., drug, device or biologic)—to further clarify how they can comply with the 2016 final rule on postmarketing safety reporting requirements (PMSR) for combination products. Although the PMSR regulations for drugs, devices and biological products have many similarities, each set of regulations establishes distinct safety reporting requirements, including standards and timeframes. This final guidance explains, among other things, which combination products are impacted by the PMSR requirements, how to submit reports, recordkeeping requirements, and how to avoid duplications when submitting safety information to the agency. This final guidance provides examples for both drug and device-led combination products with detailed flowcharts explaining which reports are required under the PMSR rule, and discusses the content for these reports, and when they are due to the FDA. To ensure applicants have sufficient time to make necessary adjustments, the FDA announced in April that the agency does not intend to enforce the additional constituent part-based PMSR requirements until July 2020 for most combination products, and until January 2021 for vaccine combination product. ]]> https://biospectrumindia.com/news/22/14227/health-ministry-inks-mou-with-ayush-for-tb-eradication.html https://biospectrumindia.com/news/22/14227/health-ministry-inks-mou-with-ayush-for-tb-eradication.html Fri, 19 Jul 2019 11:00:00 +0530 Ministry of AYUSH and Ministry of Health & Family Welfare have signed an MoU to forge inter-sectoral convergence at the level of policy, planning and programme implementation for accelerated response towards “Tuberculosis Free India” initiative. The intended collaboration between the two Ministries aims at development of linkages and integration of TB care services within the infrastructure and institutional network of AYUSH. The MoU was signed by Secretary Health and Family Welfare Preeti Sudan and  Secretary AYUSH, Vaidya Rajesh Kotecha in the presence of Minister of Health and Family Welfare Dr Harshvardhan, MoS Health and Family Welfare Ashwini Choubey and Minister of State for AYUSH and MoS Defence Shripad Yesso Naik.  On this occasion Shripad Naik said that Tuberculosis is not only a challenge for medical fraternity but also a serious social problems mainly hitting the populations battling with poverty, malnutrition, poor hygiene, housing and working conditions. The Minister said that AYUSH systems have potential knowledge base, qualified & trained human resources and holistic healthcare practices to help achieving the objective of TB- free India. He further said that accordingly, it is expected that multifaceted issues of the people suffering from TB can be addressed with integrated approaches, inter-sectoral convergence and meaningful involvement of AYUSH sector. The MoU with the Central TB Division of the Ministry of Health & Family Welfare outlines the scope and extent of AYUSH involvement in sensitization, awareness generation, capacity building of AYUSH institutions and health service providers in the areas of TB diagnosis, control and management. Focused activities envisaged under the MoU will cover joint planning to work with AYUSH organisations & professional bodies and promote adjuvant use of evidence- based AYUSH interventions for, TB control and management. It is also intended to facilitate research collaboration and best practices of AYUSH healthcare and build up capacities for TB-free work places and communities. Both Ministries will appoint Nodal Officers for development of implementation plan, modalities of operationalization and steering the collaboration activities outlined in the MoU. ]]> https://biospectrumindia.com/news/22/14216/cabinet-approves-indo-us-co-operation-for-3d-bioprinting-regenerative-medicine.html https://biospectrumindia.com/news/22/14216/cabinet-approves-indo-us-co-operation-for-3d-bioprinting-regenerative-medicine.html Wed, 17 Jul 2019 17:15:00 +0530 The Union Cabinet chaired by Prime Minister Narendra Modi has given ex-post facto approval to the Inter-Institutional Agreement between India and the USA in the areas of regenerative medicine and 3D bioprinting, new technologies, exchange of scientific ideas/information and technologies, and joint use of scientific infrastructure. Benefits: The joint research projects, training programmes, conferences, seminars etc. under this Agreement will be open to all qualified scientists and technologists, and will be supported on the basis of scientific merit and excellence.  Scientific research and technology development in the areas of regenerative medicine and 3D bio-printing will have potential for generation of new Intellectual Property, processes, prototypes or products. Both institutes anticipate the general academic exchange contemplated under the Agreement will lead to the development of specific projects, each of which may have academic, clinical and commercial implications. Salient features: The objective of the Agreement is to contribute towards the development of research and education of both the Institutions through academic collaboration. The general areas of common interest where collaboration and exchange of knowledge are intended for both include: (1)   Exchange of faculty members and students for training, study and research especially in the areas on 3D Bioprinting; (2)   Execution of joint research projects; and (3)   Exchange of information and academic publications. Background: In line with Govt. of India's stress on stronger and long-term cooperation between the Government of India and the United States of America for mutual benefit in the areas of Science and Technology, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum, an Institute of National Importance under the Department of Science and Technology (DST), Government of India, has entered into an Agreement on Academic Cooperation with the Wake Forest University Health Sciences on behalf of its Institute for Regenerative Medicine (WFIRM), North Carolina, USA.    The Agreement was signed by Prof. Asha Kishore, Director, SCTIMST on behalf of Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum and Mr. Gregory Burke, Chief Science Officer & Sr. Associate Dean for Research Admin and Prof. Anthony Atala, Director on behalf of Wake Forest University-Health Sciences on behalf of its Institute for Regenerative Medicine, North Carolina, Unites States on 13thDecember 2018. ]]> https://biospectrumindia.com/news/22/14194/health-minister-releases-national-digital-health-blueprint-report.html https://biospectrumindia.com/news/22/14194/health-minister-releases-national-digital-health-blueprint-report.html Tue, 16 Jul 2019 11:10:00 +0530 Dr Harsh Vardhan, Union Minister of Health and Family Welfare has released the National Digital Health Blueprint (NDHB) report in the public domain for inputs from various stakeholders. Speaking on the occasion, the Union Health Minister said that the Government under the guidance of the Prime Minister, Narendra Modi is committed to ensuring high quality healthcare, accessible to all up to the last mile.  “The digital health interventions are accelerating this transformation and have a huge potential for supporting Universal Health Coverage (UHC). India has everything that can help it achieve Health for all,” he stated. He said that the National Digital Health Blueprint is in line with the vision of the Prime Minister to reach each individual of this country with services at their doorstep under Digital India Programme. Ashwini Kumar Choubey, Minister of State for Health and Family Welfare, Preeti Sudan, Secretary (HFW), J. Satyanarayana, Former Chairman-UIDAI and Chairman of Committee on NDHB, Sanjeeva Kumar, AS & DG (CGHS),AS (Health) and Lav Agarwal, Joint Secretary, also graced the occasion. Speaking at the event, the Union Health Minister appealed to all the stakeholders to provide their valuable feedback and inputs to make this digital revolution in healthcare more inclusive and collaborative and to help Government in building a stronger nation as a collective endeavour.  He further stated that the Government is strongly committed to Universal Health Coverage (UHC).  He mentioned that the rapid transformation in healthcare service delivery in today’s world is known to everyone and the way we know of healthcare being delivered and accessed is poised to change for the better. “The digital health interventions are accelerating this transformation and have a huge potential for supporting Universal Health Coverage,” Dr Harsh Vardhan said. Stressing on integration of various digital health services, Dr Harsh Vardhan said that the need of the hour is to create an ecosystem which can integrate the existing health information systems and show a clear path for upcoming programmes for ensuring interoperability of Electronic Health Record (EHR). “We have made a mark in history by launching Ayushman Bharat Yojana which is operational on a robust IT Platform. Other IT enabled schemes like Reproductive Child Healthcare, NIKSHAY etc. are also benefitting the patients at right time with right service delivery. There is a need to ensure convergence across these IT systems to monitor and provide health services in a robust and efficient manner. Ministry of Health has accordingly initiated efforts in the direction of a comprehensive, nationwide integrated e-Health system under National Digital Health Blueprint, he mentioned. The vision of NDHB is to create a National Digital Health Eco-system that supports Universal Health Coverage in an efficient, accessible, inclusive, affordable, timely and safe manner, through provision of a wide-range of data, information and infrastructure services, duly leveraging open, interoperable, standards-based digital systems, and ensuring the security, confidentiality and privacy of health-related personal information. ]]> https://biospectrumindia.com/news/22/14139/health-ministry-emphasizes-on-organ-donation-for-transplantation.html https://biospectrumindia.com/news/22/14139/health-ministry-emphasizes-on-organ-donation-for-transplantation.html Tue, 09 Jul 2019 11:05:00 +0530 “People’s participation and people’s awareness is the key for encouraging organ donation.” This was stated by Ashwini Kumar Choubey, Minister of State (HFW) at the silver jubilee function of The Transplantation of Human Organs Act (THOA), 1994 , organized by the National Organ and Tissue Transplant Organization (NOTTO), in New Delhi. Giving a clarion call for “Angdaan, Mahadaan, Mahakalyan,” Choubey said that people’s participation has to be ensured for this noble cause and children have to be made aware of it from the beginning. He urged other departments of the government to be involved in this movement for encouraging organ donation. In his address, Choubey said that many myths and misconceptions surround organ donation. He stated that very often, organ donation gets discouraged on the basis of superstitions. Choubey urged the people to come forward for organ donation without any fear. He also urged the states to share their data with NOTTO so that National Donor and Recipient Registries can be maintained at the central level. “This will allow a fair and seamless allocation of organs and tissues to recipients across all societal divides. The final aim of a central digitized organ allocation system that ensures a transparent allocation to recipients, both rich and poor, can only be achieved through updated data of all states and hospitals on the national database,” he elaborated. Ashwini Kumar Choubey also unveiled the silver jubilee copyof ‘The Transplantation of Human Organs Act (THOA), 1994’ and launched the online system for the objective of “Million for a Billion” pledges. ]]> https://biospectrumindia.com/news/22/14118/health-minister-chairs-review-meeting-on-prevention-and-control-of-vector-borne-diseases-.html https://biospectrumindia.com/news/22/14118/health-minister-chairs-review-meeting-on-prevention-and-control-of-vector-borne-diseases-.html Fri, 05 Jul 2019 15:15:00 +0530 Dr. Harsh Vardhan, Union Minister of Health and Family Welfare held a high level meeting to review the preparedness for prevention and control of vector borne diseases (malaria, dengue, and chikungunya) in Delhi. Satyendra Jain, Health Minister, Government of Delhi; Mayors of Delhi; Preeti Sudan, Union Health Secretary; Prof. Balram Bhargava, Secretary DHR and DG, ICMR;DGHS, MoHFW; Chairman, NDMC; Health Secretary, NCT of Delhi; Medical Supdts. of the Central Government and State government hospitals in Delhi; senior officials from Union Health Ministry and Govt. of NCT of Delhi; ICMR; NCDC and NVBDCP; and representatives of Municipal Corporations of Delhi were also present. Taking stock of the situation, Dr. Harsh Vardhan was briefed on the current situation of malaria and dengue in Delhi and the action required from the State government, Municipal Corporations, state hospitals, school education department, DHR, Railways and the Containment Board etc. Stressing on the importance of widespread awareness on prevention and control of the vector borne diseases, the Union Health Minister urged all stakeholders to undertake awareness drives through active community participation and cooperation of all stakeholders such as RWAs, shopkeepers’ and traders’ associations. He further stated that school children can play a very important role in creating awareness. They could become 'Swasthya Ambassadors' and appointed as champions for creating awareness and checking for mosquito breeding sites in their schools and neighbourhood. He further urged the state government and the Mayors to work towards making hospitals, schools and government buildings ‘Vector-Free’. Dr. Harsh Vardhan suggested that Malaria should be made a notifiable disease. Satyendra Jain assured that the same would be done immediately. It was also suggested that all hospitals, including the private ones, should appoint a nodal person for vector borne diseases to ensure that the Government and private interventions and efforts to prevent/ cure vector borne diseases, are in tandem. The Union Minister further said that to create awareness and visibility, it will be appropriate that a 2-day mass awareness drive be undertaken where the elected representatives, MPS, MLAs, Corporators, senior officials of MoHFW, state government, Municipal Corporation, NGOs, and other eminent people undertake visits in different part of Delhi and conduct a surveillance visit and check for breeding sites in their buildings (especially the roofs) and their vicinities. “When all stakeholders will come out on a single day, it will send a very strong message and nudge the public and check for breeding sites at their work space and neighbourhood”, Dr. Harsh Vardhan stated. As regards preparation to manage the cases, the representatives from the Central government hospitals informed that there was no shortage of beds, drugs, testing facilities etc., to treat the incoming patients; the Union Health Ministry has already provided all logistical and technical support to the Delhi Government in terms of surveillance and diagnostic kits to strengthen their preparations. Also, protocol for training of doctors and paramedics has been shared with the Delhi government. However, it was highlighted that people need to be informed that they should focus on the symptomatic treatment and consume lots of liquids and take rest and not rush for getting admitted in hospitals, unless required. Dr. Harsh Vardhan further stated that the focus should be on active case finding of cases and reduction of vectors. He said adequate attention should be given to building sturdy surveillance systems. Effective surveillance and monitoring was key to success in combating these diseases, he emphasized. He also stressed on strengthening the data collection mechanisms to ensure that high quality data is captured.   Satyendra Jain assured that the highest priority is being given to prevention and control of dengue,malaria and chikungunya in Delhi, and all efforts are being made in this direction.   ]]> https://biospectrumindia.com/news/22/14099/cabinet-approves-mou-between-india-and-maldives-in-health-sector.html https://biospectrumindia.com/news/22/14099/cabinet-approves-mou-between-india-and-maldives-in-health-sector.html Thu, 04 Jul 2019 10:35:00 +0530 The Union Cabinet has given ex-post-facto approval to the Memorandum of Understanding (MoU) between the Government of the Republic of India and the Government of the Republic of Maldives on cooperation in the field of Health signed on 08th June, 2019. The Memorandum of Understanding covers the following areas of cooperation: - Exchange  &  Training  of  medical  doctors, officials, other   health professionals and experts; Medical and health research development; Regulation  of  medicines  and  medical products, and  exchange  of  information thereon; Communicable and Non-Communicable diseases; E-Health and Telemedicine; and Any other area of cooperation as may be mutually decided upon. A Working Group will be set up to further elaborate the details of cooperation and to oversee the implementation of this Memorandum of Understanding.   ]]> https://biospectrumindia.com/news/22/14071/ministry-of-ayush-inks-mou-with-meity.html https://biospectrumindia.com/news/22/14071/ministry-of-ayush-inks-mou-with-meity.html Tue, 02 Jul 2019 10:45:00 +0530 Ministry of AYUSH (MOA) and Ministry of Electronics and Information Technology (MeitY) have signed an MOU at New Delhi for collaborating with each other for digitization of AYUSH Sector. MeitY has agreed to advise and give technical support to MOA for planning and development of AYUSH GRID Project. In pursuance to the National Health Policy 2017 and e-governance initiative of Ministry of AYUSH aims to  digitize the entire AYUSH leading to transformation in field of health care delivery at all levels, in addition to greater research, education, delivery of various healthcare programmes and better drug regulations. On the occasion of signing of MOU, Secretary AYUSH Vaidya Rajesh Kotecha  briefed about the vision and utility of AYUSH GRID Project and stated that this will be beneficial for all stakeholders of AYUSH including citizens of the country and in turn will help to achieve various national and international goals in healthcare. In his remarks, Secretary, MeitY Shri Ajay prakash Sawhney informed about the various MeitY led Health initiatives such as e-Hospital, e-Aushadhi, e-Rakt Kosh, Online Registration System (ORS) and e-Shushrut for digitizing the internal workflows and processes of hospitals enabling the efficient and online delivery of Health care services across the country. MeitY has also sponsored a number of R&D projects for development of Medical Electronics Devices and Systems such as Medical and Imaging equipment, establishing centre of excellence in medical electronics. MeitY has also launched an online information guide called Vikaspedia, a portal for the various social sectors including Health and it offers information in 23 languages. ]]> https://biospectrumindia.com/news/22/14046/government-foresees-resilient-health-system-in-india.html https://biospectrumindia.com/news/22/14046/government-foresees-resilient-health-system-in-india.html Mon, 01 Jul 2019 10:00:00 +0530 “Let us all work together to make the twenty-first century a human-centered century which has strong and resilient health systems, individuals and communities.” This was stated by Dr. Harsh Vardhan, Union Minister of Health and Family Welfare during his address at the Joint Session of G20 Health and Finance Ministers in Osaka, Japan. Dr. Harsh Vardhan further said that the Government of India, led by visionary Prime Minister Shri Narendra Modi Ji believes in the philosophy of ‘Sab Ka Saath; Sab Ka Vikas; Sab KaVishwas’, which means ‘inclusive development with everybody’s participation and trust’. “The financing of universal health coverage is a challenge that most developing countries are presently encountering and in this context, India endorses the G20 ‘Shared Understanding Document’,” Dr. Harsh Vardhan mentioned. In his address at the global ministers’ meet, Dr. Harsh Vardhan stated that the multi-dimensionality as well as the plurality of pathways towards the achievement of Universal Health Coverage goals are two aspects that we should be mindful of, while deliberating on this subject. “With this understanding, in India, the finance and health ministries collaborate very closely for health sector outcomes,” he added. Speaking about the big strides India has taken towards Universal Health Coverage (UHC), Dr. Harsh Vardhan said that under the dynamic stewardship of the Prime Minister, India launched the world’s largest Universal Health Coverage program, the Ayushman Bharat (Long Live India), which adopts a continuum of care approach and comprises of two inter-related components. He elaborated that the first component of Ayushman Bharat is focused on achieving preventive, promotive, curative, palliative and rehabilitative healthcare through setting up of 150,000 Health and Wellness Centres. Focus on wellness converges India’s traditional knowledge of Yoga, to eat-right, cessation of alcohol & tobacco and creating community awareness about lifestyle changes. A people’s movement on wellness has already begun in India, he said. “The Pradhan Mantri Jan Aarogya Yojna (Prime Minister Health Protection Scheme) provides health protection cover to 107.4 million poor and vulnerable families for secondary and tertiary care, assuring hospitalization cover of Rs. 5,00,000 per annum per family,” Dr. Harsh Vardhan informed the participating global health and finance ministers. The Union Health Minister further said that to generate sustainable resources a new Health and Education Cess of 4% is in place in India. Further, highest tax at very high rates is levied on tobacco products and sweetened carbonated beverages, he stated. Dr. Harsh Vardhan appreciated G20 Japanese Presidency for identifying financing of Universal Health Care as a priority agenda.  He also acknowledged the work of WHO and World Bank in advancing the Universal Health Coverage agenda. “We will welcome their support in innovative and efficient ways for strategic purchasing, service delivery and health financing,” he stated. Dr. Harsh Vardhan also visited the Suita Hospital at Osaka, Japan today and interacted with the officials at the hospital on the latest research and development in medicine like new centrifugal blood pump and portable heart lung machine. ]]> https://biospectrumindia.com/news/22/14012/health-minister-expedites-process-of-rare-disease-policy-formation.html https://biospectrumindia.com/news/22/14012/health-minister-expedites-process-of-rare-disease-policy-formation.html Thu, 27 Jun 2019 09:00:00 +0530 With the new Government taking the chair, rare disease patients in India see a new ray of hope. Last week, Union Health Minister, Dr. Harshvardhan directed ministry officials to speed up the process of formulating the National Policy for Treatment of Rare Diseases (NPTRD), in consultation with all stakeholders. Patient associations has lauded this recent move and are looking forward to a policy which is patients friendly. Rare diseases are severe and chronic illnesses and are often life-threatening. Patients suffering from rare diseases, especially Lysosomal Storage Disorders (LSDs), often lead a very incapacitating life. There are about 50 LSDs out of which only 5 have approved treatment available in India. About 180 diagnosed patients across India have submitted their application to the Govt. for treatment support for such treatable LSDs. Elaborating on the condition Dr. Ratna Puri, Senior Consultant and Chairperson, Institute of Medical Genetics and Genomics, Sir Ganga Ram Hospital, Delhi said, “Lysosomal Storage Disorders (LSDs) are a group of around 50 inherited disorders which occur due to defects in the lysosomal function. Lysosomes are enzymes performing a critical function in the body. Even if one of these enzymes are dysfunctional, it will cause one of the LSDs. Till now treatment is available only for a few of the LSDs- Pompe, Fabry, Gaucher, MPS (Type I, II, IV A, VI) and has proven to be effective. If treatment isn’t provided on time, these conditions can affect the quality of life of a patient dramatically and they are unable to do even simple daily tasks. Timely treatment is, thus, crucial for improving the quality of lives of patients.” Lauding Dr. Harshvardhan’s efforts Manjit Singh, President, LSDSS, “It has been a long and painful journey for rare disease patients and caregivers to reach this stage. 50 patients have lost their lives in this arduous journey of over 3 years. These patients could have been saved had they been provided timely treatment. In India, there are only about 400 patients who are suffering from treatable LSDs. It’s a commendable move by Dr. Harshvardhan to get NPTRD back on track. It has given a wave of optimism for rare disease patients. In the meanwhile, it would be great if the Government can provide interim treatment support to those rare disease patients who had applied to the Rare disease cell, till the time the policy gets finalized and implemented.” Prasanna Shirol, Co-Founder, Organization for Rare Diseases India (ORDI) said, “Dr. Harshvardhan’s move has directed the Central Government to play its part in finalizing NPTRD. We are hopeful that this time Government and ministry will treat every life as equal and precious and provide treatment. At the same time, health being a state subject, it is equally important for states to understand the need of the hour and create rare disease patient-friendly environment. The State Government should create rare disease center of excellence in every state to address the needs of rare disease patients with timely and effective intervention and also their own state policy based on the state priorities.” The onus now lies with the Government to act on their words and provide relief of rare disease patients in the country.     ]]> https://biospectrumindia.com/news/22/14008/niti-aayog-releases-second-edition-of-health-report-on-states.html https://biospectrumindia.com/news/22/14008/niti-aayog-releases-second-edition-of-health-report-on-states.html Wed, 26 Jun 2019 11:00:00 +0530 NITI Aayog has released the Second Edition of “Healthy States, Progressive India”. The report ranks states and Union territories innovatively on their year-on-year incremental change in health outcomes, as well as, their overall performance. The Round II report focuses on measuring and highlighting the overall performance and incremental improvement over a two year period (2016-17 and 2017-18) in the States and UTs The report was released jointly by Vice Chairman, NITI Aayog, Dr. Rajiv Kumar , Member NITI Aayog Dr. VKPaul, CEO, NITI Aayog; Amitabh Kant and the Secretary, Ministry of Health & Family Welfare; Preeti Sudan The report has been developed by NITI Aayog, with technical assistance from the World Bank, and in consultation with the Ministry of Health and Family Welfare (MoHFW).  The report is an annual systematic performance tool to measure the performance of the States and UTs. It ranks states and union territories on their year on year incremental change in health outcomes, as well as, their overall performance with respect to each other. The ranking is categorized as Larger States, Smaller States and Union Territories (UTs), to ensure comparison among similar entities. The Health Index is a weighted composite Index based on 23 indicators grouped into the domains of Health Outcomes, Governance and Information, and Key Inputs/Processes.  . Each domain has been assigned weights based on its importance and has been equally distributed among indicators. Among the Larger States, Kerala, Andhra Pradesh & Maharashtra ranked on top in terms of overall performance, while Haryana, Rajasthan and Jharkhand are the top three ranking States in terms of annual incremental performance. Haryana, Rajasthan and Jharkhand showed the maximum gains inimprovement of health outcomes from base to reference year in indicators such as Neonatal Mortality Rate (NMR), Under-five Mortality Rate (U5MR), Proportion Low Birth Weight among New-borns, Proportion of districts with functional Cardiac Care Units (CCUs), Proportion of ANCs registered within first trimester, Proportion of CHCs/PHCs with Quality Accreditation Certificates, full immunization coverage, institutional deliveries, Proportion of Specialist positions vacant at District Hospitals and Proportion of total staff (regular and contractual) with e-pay slip generated in the IT enabled Human Resources Management Information System. Among Smaller States, Mizoram ranked first followed by Manipur on overall performance, while Tripura followed by Manipur were the top ranked States in terms of annual incremental performance.  Among UTs, Chandigarh and Dadra and Nagar Haveli were ranked on top in terms of overall performance (Chandigarh-1 and Dadra and Nagar Haveli-2) as well as annual incremental performance (Dadra and Nagar Haveli-1 and Chandigarh-2).  ]]> https://biospectrumindia.com/news/22/13924/five-virological-labs-to-be-set-up-in-bihar.html https://biospectrumindia.com/news/22/13924/five-virological-labs-to-be-set-up-in-bihar.html Tue, 18 Jun 2019 11:15:00 +0530 Dr. Harsh Vardhan, Union Minister of Health and Family Welfare, upon his return from Muzaffarpur, has reviewed the situation arising from the reported cases of Acute Encephalitis Syndrome and Japanese Encephalitis (AES/JE) in Bihar in a high level meeting which was attended by senior officers of the Health Ministry, ICMR, and AIIMS. Ashwini Kumar Choubey, MOS(HFW) was also present at the meeting. Dr. Harsh Vardhan said that five virological labs will be set up in different districts in the State.  The location of the district can be decided in consultation with the State Government and can be funded through National Health Mission (NHM), he stated. “To establish the cause of the disease, there is urgent need for an inter disciplinary, high quality research team.  The research team shall work with the children suffering from AES/JE looking at various aspects including periodicity, cycle of disease, environmental factors and metrological data, besides other factors”, Dr. Harsh Vardhan stated. Emphasising the need for early detection and treatment of hypoglycemia cases after nearly 100 children lost their lives to encephalitis in Bihar, Dr. Harsh Vardhan said that a dedicated team of doctors should be placed in endemic primary health centres (PHCs) with required facilities at least for 3 to 4 months before and during onset of disease and they may be incentivised under NHM appropriately. As for present, the concerned primary and community health centres should take prompt corrective measures for hypoglycaemia at the facility itself to utilize the golden hour, he added.   ]]> https://biospectrumindia.com/news/22/13886/nha-qci-to-fast-track-digital-certification-for-hospitals.html https://biospectrumindia.com/news/22/13886/nha-qci-to-fast-track-digital-certification-for-hospitals.html Fri, 14 Jun 2019 09:00:00 +0530 National Health Authority (NHA) and Quality Council of India (QCI) has signed an MoU for launching a joint initiative of digital certification for Ayushman Bharat - Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) empanelled hospitals. The initiative will help the hospitals to get fast-track certification while enhancing healthcare services. The partnership aims to create a process to facilitate certification of at least 7,000 empanelled hospitals by December 2021 to build a network of quality healthcare providers. The MoU seeks to put in place a simple, swift, transparent and paperless mechanism to encourage the hospitals to apply for certification. Following the existing policy of incentivising the accredited hospitals, NHA also plans to incentivise the certified hospitals with higher reimbursement rates so that more hospitals apply for certification. There will be three levels of AB-PMJAY quality certifications: Bronze, Silver and Gold with Gold being the highest level under this initiative. Speaking about the partnership Dr. Indu Bhushan, CEO AB-PMJAY and NHA said, “There is an urgent need to help hospitals to get certified to improve the quality healthcare ecosystem in the country. NHA, therefore, has decided to collaborate with QCI and use its well-established systems, skills and credibility for hospital certification. This will boost confidence of beneficiaries in the quality of care being provided under the scheme.” Since the treatment rates are fixed and health care providers have been identified, high quality treatment becomes a prime concern of the scheme. The NHA, which is implementing AB-PMJAY, is keeping a watch on the treatment outcomes being achieved by the empanelled hospitals. To ensure quality in healthcare, another accepted way is to monitor at the input level, and certification of the healthcare providers is the right approach for the same. Hospitals which are already certified by nationally or internationally recognized accreditation body can also avail the benefits of the scheme. NABH’s Entry-Level/ NQAS certified hospitals can apply for AB PM-JAY Silver quality certification and hospitals with NABH’s Full Accreditation/JCI accreditation can apply for AB PM-JAY Gold quality certification directly. Additionally, AB PM-JAY Bronze quality certified hospitals can apply for Silver and later for Gold after successive time period of six months. Adil Zainulbhai, Chairman, QCI said, “At every step, QCI will be NHA’s partner to achieve the goal of certification of hospitals across India. The joint initiative of NHA and QCI will definitely help the country in achieving the goal of quality healthcare.” The MoU was signed by Dr. Arun Gupta, Executive Director, National Health Authority and Dr. Ravi P. Singh, Secretary General, Quality Council of India. ]]> https://biospectrumindia.com/news/22/13884/cabinet-approves-moc-between-india-kyrgyzstan-to-strengthen-healthcare.html https://biospectrumindia.com/news/22/13884/cabinet-approves-moc-between-india-kyrgyzstan-to-strengthen-healthcare.html Thu, 13 Jun 2019 13:10:00 +0530 The Union Cabinet, chaired by the Prime Minister Narendra Modi, has approved a Memorandum of Collaboration (MoC) between India and Kyrgyzstan for collaborative research work on High Altitude Biology and Medicine and aiming at further development and strengthening of mutual relationships in science and medicine, especially in high altitude biology and medicine. The MoC will help in understanding the physical and mental picture of soldier system at high altitude and mitigate the high altitude related maladies by using Yoga practice, herbals and neutraceuticals in Indian and Kyrgyz solders/population. The Cabinet has also approved the proposal of the Ministry of Health & Family Welfare for signing a Memorandum of Understanding (MoU) between the Ministry of Health & Family Welfare of the Republic of India and the Ministry of Health of the Kyrgyz Republic in the field of Health. The Memorandum of Cooperation covers the following areas of cooperation:- Strengthening of healthcare systems; Non-communicable diseases, communicable diseases and anti-microbialresistance; Development of hospital management systems and health informationsystems Hospital Management; Maternal and child health; Medical Researches; Exchange of experience in transplantation of kidney and liver, cardiacsurgery, oncology, orthopedics, traumatology, etc.; Improving capacity of human resources in the field of health; Exchange of information and experience in the field of regulation ofpharmaceuticals & medical devices circulation; Exchange of experience and information on good practice of clinical trials ofmedicines and medical products; Integrated surveillance of diseases; Arranging visits for the experience exchange among physicians, nurses andIT-specialists; Exchange of experience on e-health; Providing  opportunities   for  health  specialists   to  receive  training  andprofessional development at the "India-Kyrgyz Center for InformationTechnologies" with further internships in the Republic of India; Health Tourism; and Any other area of cooperation as may be mutually decided upon. ]]> https://biospectrumindia.com/news/22/13855/agreement-worth-287m-to-improve-healthcare-in-tamil-nadu.html https://biospectrumindia.com/news/22/13855/agreement-worth-287m-to-improve-healthcare-in-tamil-nadu.html Tue, 11 Jun 2019 09:00:00 +0530 The Government of India, Government of Tamil Nadu (GoTN) and the World Bank recently signed a $287 million loan agreement for the Tamil Nadu Health System Reform Program. The program aims to improve the quality of health care, reduce the burden of non-communicable diseases (NCDs), and fill equity gaps in reproductive and child health services in Tamil Nadu.   Tamil Nadu ranks third among all Indian states in the NITI Aayog Health Index which is reflected in vastly improved health outcomes. The state’s maternal mortality rate has declined from 90 deaths per 100,000 live births in 2005 to 62 deaths in 2015-16 while infant mortality has declined from 30 deaths per 1000 live births to 20 in the same period. A key contribution to these achievements has been the establishment of emergency obstetric and neonatal care centers and the 108 ambulance service with previous support from the World Bank. These have ensured that no mother travels more than 30 minutes to access emergency obstetric and neonatal care 24 hours a day, seven days a week.  Despite these impressive gains, certain challenges in health care remain, including quality of care and variations in reproductive and child health among districts. Tamil Nadu is also dealing with a growing burden of NCDs as they account for nearly 69 percent of deaths in the state. The Tamil Nadu Health System Reform Program will support the state government to: develop clinical protocols and guidelines; achieve national accreditation for primary, secondary, and tertiary-level health facilities in the public sector; strengthen physicians, nurses and paramedics through continuous medical education; strengthen the feedback loop between citizens and the state by making quality and other data accessible to the public. Sameer Kumar Khare, Additional Secretary, Department of Economic Affairs, Ministry of Finance said, "Tamil Nadu can serve as a model for how to take health system performance to the next level by investing in the public sector and offer lessons to other states. We are happy that the World Bank is helping the state in this journey.” The agreement for the Project was signed by Sameer Kumar Khare, Additional Secretary, Department of Economic Affairs, Ministry of Finance, on behalf of the Government of India, Beela Rajesh, Secretary, Health and Family Welfare Department, on behalf of the Government of Tamil Nadu and Hisham Abdo, Acting Country Director, World Bank India, on behalf of the World Bank. Hisham Abdo, Acting Country Director, World Bank said, “Investing in state capacity is a must if Tamil Nadu is to address the growing and changing demands for health care of its population. This program invests in improving the management of the state’s health sector by scaling up good practices and innovations from Tamil Nadu and leveraging the relevant experiences internationally.” The program will promote population-based screening, treatment and follow-up for NCDs, and improve monitoring and evaluation. Patients will be equipped with knowledge and skills to self-manage their conditions. Lab services and health provider capacity will also be strengthened to address mental health. To tackle road injuries, the program will improve in-hospital care, strengthen protocols, strengthen the 24x7 trauma care services and establish a trauma registry. Rifat Hasan, Senior Health Specialist, World Bank India, and the Task Team Leader for the program said, “This Program focuses on results instead of inputs through a Program-for-Results (PforR) lending instrument. This will provide a much greater focus on outputs and outcomes through better alignment of expenditures and incentives with results. The use of the PforR instrument is a first for the health sector and will offer lessons for other states.” Another key aim of this program is to reduce the equity gaps in reproductive and child health.  Special focus will be given to nine priority districts, which constitute the bottom quintile of the RCH indicators in the state and have a relatively large proportion of tribal populations.  ]]> https://biospectrumindia.com/news/22/13848/rationalize-taxes-duties-in-budget-2019-20-mtai.html https://biospectrumindia.com/news/22/13848/rationalize-taxes-duties-in-budget-2019-20-mtai.html Mon, 10 Jun 2019 12:55:00 +0530 Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies with large footprint in manufacturing, R&D and training in India have said Union Budget 2019-20 should reduce taxes and duties to enable continuous supply of quality medical devices in the country. The current regulatory regime mandates absolute price ceiling for medical devices like orthopaedic implants and stents, and allows a limited 10% annual price increase for other notified products. This is irrespective of cost challenges and exchange rate increases faced by companies. Approximately, 70% of medical devices are imported into India to meet the rising demand for quality healthcare. Sanjay Bhutani, Director, MTaI said, “India is witnessing a spurt in demand for quality healthcare, and our member companies are committed to providing the latest technology in the Indian market. Since the government is trying to reduce the cost of healthcare, it must do so without compromising the ability of the industry to bring innovation to the Indian patients, this also requires streamlining of the tax structure and rationalization of duty regime with immediate effect.” The following issues need immediate measures in the budget this year: High Custom Duties: High custom duties have adversely impacted the costs of products in India which contradicts the government’s efforts to provide low-cost healthcare available to masses through the Ayushman Bharat program (PMJAY). We seek reduction of custom duties to 2.5% including all surcharges. Additionally, since the custom duty regime on most medical devices in neighbouring countries of Nepal, Myanmar, Sri-Lanka, and Bhutan is lower than in India, the duty differential could lead to smuggling of low-bulk-high-value devices. The result will not only be loss of revenue for the government but also the patient will be beset with products which are not backed by adequate legal and service guarantees.  Another point to note is that China, which has near self-sufficiency in segments like consumables, has reduced custom duties from 4% to 3.3% recently to avoid the problem of smuggling and to inject competition in the sector. Customs Duty & GST on Spare Parts: Custom duty on spare parts of the medical equipment are currently charged at a higher rate than the equipment itself. For example Heart Lung Machine attracts basic custom duty of 7.5% & GST of 12% whereas its spare parts like Roller Pump attracts basic customs duty of 10% and GST of 18%. Similarly, GST on Contact Lenses is 12%, whereas the Contact Lens Solution which is the essential part of using Contact Lenses attract 18% GST. We recommend that the same customs duty and GST should be charged on spare parts and medical equipment. Tax Holiday for R&D: Tax holiday should be provided to medical device R&D centres under the Transfer Pricing Act to boost investment in setting up in-house R&D capabilities. We also seek tax incentives for the industry for developing global patents from India and tax deduction on income made by individuals or a company for rewards earned on patent development or patent licensing. Minimum Alternate Tax: We urge the government to reduce Minimum Alternative Tax (MAT) rate to 15% from the present effective rate of 21.34% (including surcharge and education Cess). The high rate of MAT has cast substantial burden on companies which are already affected by various external factors. Conceptually, MAT is a minimum and an alternate tax and hence it should not be at a rate which is more than 50% of the basic corporate tax rate. GST on Trials and Samples: GST should not be charged on trials and samples as doctors need samples/free trials/demos in order to satisfy themselves on efficacy of product in best interest of patients. Cost of trials are already built into cost structures and is a business expense. GST on Expiries: Medical device suppliers take back product expiries as per best business practice, and in order to ensure product availability at all times. However, the input GST needs to be reversed on such expiries which causes undue loss to the Industry, raising their cost of operations. We recommend that for market expiry replacements, the GST credit be available to suppliers as normal supplies. Cost of expiries are already built into cost structures and hence is a business expense and not allowing input credit contradicts basic edifice of GST. Time-limit of 6 months on Sale on Approval (SOA) transaction in GST: Hospitals require device suppliers to keep critical devices in all sizes, shapes, sizes as the actual need is known only at the last minute at the time of surgery. Hence complying with the 6 months norm for charge of GST is causing a lot of distress for device suppliers and hospitals. A 24 months period will allow device suppliers to keep entire variants without issue of GST exposure on unconsumed items, while also not impacting critical patient care. GST on Healthcare Services: Healthcare services are currently exempt from GST. As a result, hospitals are not able to claim GST input. This results in higher cost of treatment for the patient.  Once zero rated, Hospitals will be able to avail GST credit on inputs, leading to lower healthcare services cost. Expenditure on CSR: Expenditure on CSR is being disallowed in tax computation. CSR Expenditure has been mandated under law and therefore should be claimable as tax deductible expenditure. Tax Incentives on Exports: Currently, there are no tax benefits on export income. Export being a growth engine for the economy it is important that efforts should be made to make it competitive in the international market. India’s export performance in last 2-3 years has been on a decline which impacts the balance of trade. Introduction of export incentives related to direct tax exemption for the export profits would attract more investments to sectors like medical devices.         ]]> https://biospectrumindia.com/news/22/13818/health-minister-urges-delhi-odisha-telangana-wb-to-join-ab-pmjay.html https://biospectrumindia.com/news/22/13818/health-minister-urges-delhi-odisha-telangana-wb-to-join-ab-pmjay.html Thu, 06 Jun 2019 10:50:00 +0530 Dr. Harsh Vardhan, Union Minister of Health and Family Welfare, upon assuming charge of the Health Ministry immediately, wrote a letter to the Chief Ministers of Delhi, Odisha, Telangana, and West Bengal urging them to join the Government of India’s flagship health protection scheme, Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY). Taking stock of the situation that three States and one Union Territory (UT) are yet to join the Government of India in implementing AB-PMJAY, he said, “It is important that the benefits of the visionary scheme like Ayushman Bharat should reach all deprived and vulnerable people in the country." Dr Harsh Vardhan pointed out that implementing AB-PMJAY would prove highly beneficial for not just the State but equally importantly to its people and all stakeholders. The ultimate beneficiary of this collaboration will be poor and vulnerable people. Due to the portability of services, the states will gain from the nationwide network of hospitals and will also help provide services in their own state to those from outside their states, he elaborated.  ]]> https://biospectrumindia.com/news/22/13800/dr-harsh-vardhan-reviews-the-public-health-measures-for-nipah-virus.html https://biospectrumindia.com/news/22/13800/dr-harsh-vardhan-reviews-the-public-health-measures-for-nipah-virus.html Tue, 04 Jun 2019 11:25:00 +0530 Following confirmation of a suspect case of Nipah Virus Disease by National Institute of Virology (NIV) Pune, an urgent meeting was convened by the Union Minister of Health and Family Welfare, Dr. Harsh Vardhan at his residence recently. The officers present at the meeting were Preeti Sudan, Secretary (HFW); Dr. Balram Bhargava, Secretary (DHR); Sanjeeva Kumar, Addl. Secretary (H); Dr. S. Venkatesh, DGHS; Dr. Sujeet K Singh, Director, NCDC and Dr. Gangakhetkar, Scientist G and Head ECD, ICMR. The Union Health Minister Dr. Harsh Vardhan spoke to the Health Minister of Kerala, K. K. Shailaja, and discussed the current situation and assured all support from the Centre. The following actions have been taken: A Central Team with six officers has been deployed and have reached for epidemiological investigation protocol, contact tracing for early detection of suspects, testing protocols for suspects and review of isolation facilities A Control room established and NCDC Strategic Health Operations Center (SHOC) activated. The phone number of control room is number 011-23978046. A team from National Institute of Virology, Pune (ICMR) with Monoclonal Antibodies is being sent to Ernakullam. A team from NIV for conducting/testing bats for Nipah virus is being dispatched today. The Union Health has spoken to DG Forest to extend all cooperation in this regard. The State has already initiated the following actions: Contact tracing and surveillance Standard capacity building for health functionaries, ambulance fleet drivers and others Infection control activities in hospitals. Dedicated trained teams to handle cases Rapid Response Teams at institutions Help desk at Medical College Ernakulam established. Dedicated trained doctors, nurses, paramedics at hospitals. Vigil activated in all districts. Awareness generation.   ]]> https://biospectrumindia.com/news/22/13704/national-health-authority-inks-partnership-with-ncg.html https://biospectrumindia.com/news/22/13704/national-health-authority-inks-partnership-with-ncg.html Fri, 24 May 2019 09:00:00 +0530 National Health Authority (NHA) and National Cancer Grid (NCG) have signed an MoU to develop uniform standards of patient care to battle cancer under Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (AB - PMJAY).  National Cancer Grid (NCG) is an initiative of the Government of India to create a network of cancer centres, research institutes, patient groups and charitable institutions across India. Owing to the multi-disciplinary nature of care required for cancer management, both NHA and NCG recognize the importance of collaborative efforts required to strengthen delivery of cancer services under AB - PMJAY with common objectives to reduce cancer burden, ensure uniform standards of patient care towards effective and efficient patient-centric care, improve access to cancer services and ensure financial risk protection with minimum prevalence of catastrophic health spending and impoverishment. The NCG and NHA officials met in New Delhi to discuss their new partnership on a wide range of ideas to improve cancer care in India. The main objectives of this collaboration include developing uniform standards of patient care for prevention, diagnosis, and treatment of cancer; providing specialized training and education in oncology and facilitating collaborative basic, translational and clinical research in cancer. NHA and NCG will jointly review existing cancer treatment packages, pricing of services, standard treatment workflows covered under AB-PMJAY and plug in necessary gaps to ensure enhanced quality of cancer care. Both organisations will work on creating cancer services/package benefits based on priority setting tenets such as evidence of efficacy, value (cost-effectiveness), low harm, demand/ burden, medical necessity, and wide availability. NCG will work closely with NHA to rationalize payment rates for different benefit packages and treatment/diagnosis plans, and also explore mechanisms to signal right incentives to providers to ensure quality through pricing mechanisms. Highlighting his views on this new partnership, Dr. Indu Bhushan, CEO, Ayushman Bharat PM-JAY, and National Health Authority, said, “We are glad to partner with National Cancer Grid and welcome their expertise in enhancing the cancer care services provided under AB - PMJAY. We look forward to NCG’s support and expertise in enabling us to expand our service delivery network by actively encouraging its member hospitals to empanel with AB - PMJAY.” Speaking on the occasion, Prof. R A Badwe, Director, Tata Memorial Centre said, “Our meeting with National Health Authority has been extremely fruitful. We are partnering with NHA to establish and optimize processes and guidelines to implement top-notch standards across all levels of cancer treatment and care under AB - PMJAY.” The MOU signing was attended by Dr. Dinesh Arora, Deputy CEO, AB - PMJAY and NHA, Prof. C.S. Pramesh, Director Tata Memorial Hospital and Dr. Arun Gupta, Executive Director, Health Network and Quality Assurance, NHA.   ]]> https://biospectrumindia.com/news/22/13706/dbt-ministry-of-st-and-dae-collaborate-for-cancer-research.html https://biospectrumindia.com/news/22/13706/dbt-ministry-of-st-and-dae-collaborate-for-cancer-research.html Thu, 23 May 2019 14:15:00 +0530 The Department of Biotechnology (DBT), Ministry of Science & Technology and the Department of Atomic Energy (DAE), Government of India have signed an MOU for supporting joint collaborative research programmes in the area of Cancer. Signing the MoU, Dr Renu Swarup, Secretary DBT and K N Vyas, Secretary DAE expressed solidarity to work towards the common goal of tackling cancer and this is expected to bring a quantum change in the present scenario of cancer research. The DAE is represented by its Tata Memorial Centre and which also functions as the coordinating centre on behalf of The National Cancer Grid of India. This MOU aims to help strengthen the various initiatives specifically for cancer viz.  Strategizing and prioritizing cancer research, development of new and affordable technologies, jointly design and fund clinical trials, coordinate and collaborate for translational research, interventions, training of manpower and infrastructure development. The clinicians will work in coherence with Researchers to identify and develop collaborative research programmes and public health initiatives for awareness of the public at large. Various activities like joint clinical fellowships, intensive workshops on clinical research methodologies and protocol development will work towards creating a community of trained manpower and provide a platform to utilize their acquired skills in the best possible manner. ]]> https://biospectrumindia.com/news/22/13687/interactive-meet-on-new-drugs-and-clinical-trials-rules-2019-by-cdsa-thsti-and-cdsco-.html https://biospectrumindia.com/news/22/13687/interactive-meet-on-new-drugs-and-clinical-trials-rules-2019-by-cdsa-thsti-and-cdsco-.html Tue, 21 May 2019 15:00:00 +0530 The New Drugs and Clinical Trials Rules 2019 was released on March 19, 2019 by CDSCO, Ministry of Health & Family Welfare, Government of India. This regulation is a turning point for drug innovation and promoting ethical clinical research in India. It is of utmost importance that all stakeholders (pharmaceutical industry, national scientific laboratories, contract research organisations, scientists and academicians, innovators and start-ups) including international partners are fully aware of the transformed regulatory landscape in India. There has a been demand from all over the country seeking clarifications on various issues. Realising this, Clinical Development Services Agency (CDSA), Translational Health Science & Technology Institute (THSTI), Department of Biotechnology, Government of India organised a half day ‘Interactive meet on New Drugs and Clinical Trials Rules 2019: Its understanding and impact’ at THSTI, NCR Biotech Science Cluster in collaboration with Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare. Over 535 participants from more than 180 institutions participated in this interactive meet. The interactive session was live streamed and was viewed by institutions in India and abroad. The Keynote Address was delivered by Dr. S. Eswara Reddy [DCG(I), CDSCO] and Prof. Y. K. Gupta [Principal Adviser (Projects), THSTI, DBT] delivered the talk highlighting the changes and rationale behind. The panel discussion was addressed by Prof. Gagandeep Kang [Executive Director, THSTI], Prof. Shinjini Bhatnagar [Dean, Clinical Research, THSTI], Prof. Usha Menon [Strategy Lead, CDSA, THSTI], Prof. Y. K. Gupta and A. K. Pradhan [DDC(I), CDSCO]. Following regulatory changes were highlighted: For the first time, orphan drug has been defined as a drug intended to treat a condition which affects less than five lakh persons in India. Clinical trial fee for such drugs have been waived off with a provision of fast track approval. To promote drug development and research in India, the timelines of approval process has been defined as 30 days. If no objection/query is raised by the CDSCO (regulators), then the application will be deemed as ‘approved’. Provision of post trial access was made for patients for whom, the new drug has been found to be effective and there is no alternative. This will be provided free of cost by the sponsor. It is now clarified that any type of study involving human which is not a drug trial under regulation will be governed by the National ethical guidelines for biomedical and health research involving human participants by ICMR. Compensation of any study related serious adverse events will be decided by the Ethics Committee. It is now mandatory that all Ethics Committees must be registered with CDSCO before they can approve any regulatory clinical trial. However, accreditation by NABH, QCI is not mandatory although recommended. For granting approval of non-regulatory trials, there should be Ethics Committee which need to be registered with DHR, Ministry of Health. This will be effective September, 2019. Several queries by the attendees were responded succinctly by the regulator and panelists. CDSA, THSTI announced starting of an interactive discussion forum on clinical research related issues in national interest.   ]]> https://biospectrumindia.com/news/22/13515/who-calls-for-strengthening-regulatory-cooperation-in-sea-region.html https://biospectrumindia.com/news/22/13515/who-calls-for-strengthening-regulatory-cooperation-in-sea-region.html Thu, 02 May 2019 11:25:00 +0530 The WHO South-East Asia Regional Office (SEARO) had the 3rd Annual Meeting of South-East Asia Regulatory Network (SEARN) on 24th and 25th April 2019 in Delhi. Regulators from across the region met to develop approaches to working together to increase reliance and referral to promote rapid access to high quality, efficacious and safe products for patients. Network National Regulatory Authorities is responsible for regulation of medical products, including medicines, vaccines, biological and medical devices and diagnostics for human use in the eleven countries of the South East Asia Region. "The South-East Asia Regulatory Network’s efforts to increase access to quality medical products is crucial to achieving universal health coverage and the Sustainable Development Goals to ensure healthy lives and promote health and well-being for all, at all ages,” Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region said. WHO is committed to supporting SEARN to enhance country cooperation, and in doing so, work towards sharing regulatory resources. These outcomes will be especially useful to countries, she added.   ]]> https://biospectrumindia.com/news/22/13496/icmr-introduces-malaria-elimination-research-alliance.html https://biospectrumindia.com/news/22/13496/icmr-introduces-malaria-elimination-research-alliance.html Tue, 30 Apr 2019 11:15:00 +0530 ICMR has launched the Malaria Elimination Research Alliance (MERA)- India and organized the Stakeholders’ Meeting at ICMR Hqrs, New Delhi on 24 April to have vibrant discussions on the roadmap of the Alliance. National and International leaders of malaria research, officials from Government of India, NGOs participated in the daylong meeting. Indian Council of Medical Research has established ‘Malaria Elimination Research Alliance-India (MERA-India)’ which is a conglomeration of partners working on malaria control. The principal activity of the Alliance is to prioritize, plan, conduct, scale up and translate relevant research in a coordinated and combinatorial way in order to have a tangible impact of this research on the population at risk for malaria. The purpose of MERA India is to identify, articulate, prioritize and respond to the research needs of the country to eliminate malaria from India by 2030. MERA India will facilitate trans-institutional coordination and collaboration around a shared research agenda which responds to not only to programmatic challenges and addresses gaps in available tools but also proactively contribute to targeted research. MERA India aims to harness and reinforce research in coordinated and combinatorial ways in order to achieve tangible impact on malaria elimination.   ]]> https://biospectrumindia.com/news/22/13424/mou-signed-between-ministry-of-ayush-and-csir.html https://biospectrumindia.com/news/22/13424/mou-signed-between-ministry-of-ayush-and-csir.html Mon, 22 Apr 2019 16:15:00 +0530 A Memorandum of Understanding (MOU) has been signed between the Ministry of AYUSH and Council of Scientific and Industrial Research (CSIR), New Delhi for cooperation in research and education in areas of traditional systems of medicine and its integration with modern science. The MoU was signed by Vaidya Rajesh Kotecha, Secretary, Ministry of AYUSH and Dr. Shekhar C. Mande, Director General, CSIR and Secretary, DSIR in the presence of senior officials from both the organizations. Speaking on the occasion, Secretary stated in due cognition of the growing interest of traditional medicines worldwide, there is a need of multipronged and innovative approaches for the acceptance of this science. He said that the combination of traditional healthcare and modern basic science has a huge possibility to do innovative and path-breaking researches which can be used for the explanation of various basic concepts. DG, CSIR appreciated the ongoing projects and programmes between the two organizations. He stated that enhancing the collaboration through joint R&D efforts ranging from fundamental science to validation and thereafter product development, will significantly help in the growth of the Indian contributions to this important sector, not only nationally but internationally as well. Futuristic efforts of this inter-ministerial cooperation shall include pursuit of Data mining & analytics and Artificial Intelligence to enable and facilitate concepts such as “Traditional knowledge inspired drug discovery and development” and “Food as Medicine”. Previously, CSIR jointly with Department of AYUSH (now Ministry) developed the Traditional Knowledge Digital Library (TKDL), a globally recognized proprietary database on Indian systems of medicine for preventing bio-piracy and misappropriation of our traditional knowledge. The constituent laboratories of CSIR and councils of the Ministry of AYUSH have also supported each other in the development of improved varieties and captive cultivation of the medicinal plants including rare, engendered and threatened (RET) species, Botanical Reference Standards and Pharmacopoeial standards, and Ayurgenomics, among many others. In due cognition of the upward surge in the usage of herbal medicines and supplements globally, the endeavor of Ministry of AYUSH and CSIR today is to bring the organizations under an umbrella understanding for pursuing focused R&D efforts in the domain. Under the MoU, both organizations shall jointly endeavor to pursue:  R&D covering fundamental research; AYUSH specific diagnostic tools; linking microbiome, gene expression and prakriti; multi-ingredient herbal formulations, including their standardization; exploring modern scientific methods for integration with traditional Indian Systems of Medicine (ISM); linking disease signatures; etc.; Furthering the collaboration in preserving and protecting traditional knowledge related to the Indian systems of healthcare, through the existing TKDL platform; and Development of international standardized terminologies (disease-morbidity codes) in Ayurveda, Siddha and Unani (ASU), Database on Medicinal plants, Foods, etc.   ]]> https://biospectrumindia.com/news/22/13423/ministry-of-ayush-csir-sign-mou-to-promote-traditional-medicines.html https://biospectrumindia.com/news/22/13423/ministry-of-ayush-csir-sign-mou-to-promote-traditional-medicines.html Mon, 22 Apr 2019 16:10:00 +0530 A Memorandum of Understanding (MOU) has been signed between the Ministry of AYUSH and Council of Scientific and Industrial Research (CSIR), New Delhi for cooperation in research and education in areas of traditional systems of medicine and its integration with modern science. The MoU was signed by Vaidya Rajesh Kotecha, Secretary, Ministry of AYUSH and Dr. Shekhar C. Mande, Director General, CSIR and Secretary, DSIR in the presence of senior officials from both the organizations. Speaking on the occasion, Secretary stated in due cognition of the growing interest of traditional medicines worldwide, there is a need of multipronged and innovative approaches for the acceptance of this science. He said that the combination of traditional healthcare and modern basic science has a huge possibility to do innovative and path-breaking researches which can be used for the explanation of various basic concepts. DG, CSIR appreciated the ongoing projects and programmes between the two organizations. He stated that enhancing the collaboration through joint R&D efforts ranging from fundamental science to validation and thereafter product development, will significantly help in the growth of the Indian contributions to this important sector, not only nationally but internationally as well. Futuristic efforts of this inter-ministerial cooperation shall include pursuit of Data mining & analytics and Artificial Intelligence to enable and facilitate concepts such as “Traditional knowledge inspired drug discovery and development” and “Food as Medicine”. Previously, CSIR jointly with Department of AYUSH (now Ministry) developed the Traditional Knowledge Digital Library (TKDL), a globally recognized proprietary database on Indian systems of medicine for preventing bio-piracy and misappropriation of our traditional knowledge. The constituent laboratories of CSIR and councils of the Ministry of AYUSH have also supported each other in the development of improved varieties and captive cultivation of the medicinal plants including rare, engendered and threatened (RET) species, Botanical Reference Standards and Pharmacopoeial standards, and Ayurgenomics, among many others. In due cognition of the upward surge in the usage of herbal medicines and supplements globally, the endeavor of Ministry of AYUSH and CSIR today is to bring the organizations under an umbrella understanding for pursuing focused R&D efforts in the domain. Under the MoU, both organizations shall jointly endeavor to pursue:  R&D covering fundamental research; AYUSH specific diagnostic tools; linking microbiome, gene expression and prakriti; multi-ingredient herbal formulations, including their standardization; exploring modern scientific methods for integration with traditional Indian Systems of Medicine (ISM); linking disease signatures; etc.; Furthering the collaboration in preserving and protecting traditional knowledge related to the Indian systems of healthcare, through the existing TKDL platform; and Development of international standardized terminologies (disease-morbidity codes) in Ayurveda, Siddha and Unani (ASU), Database on Medicinal plants, Foods, etc.   ]]> https://biospectrumindia.com/news/22/13375/cabinet-approves-mou-between-india-and-bolivia-in-the-field-of-homoeopathy.html https://biospectrumindia.com/news/22/13375/cabinet-approves-mou-between-india-and-bolivia-in-the-field-of-homoeopathy.html Tue, 16 Apr 2019 12:40:00 +0530 The Union Cabinet chaired by Prime Minister Narendra Modi has given ex-post facto approval to the Memorandum of Understanding between India and Bolivia in the Field of Traditional Systems of Medicine and Homoeopathy. The MoU was signed in Bolivia in March, 2019. The MoU will provide a framework for cooperation, and will be mutually beneficial between the two countries for promotion of traditional systems of medicine and homoeopathy. It will lead to promotion and propagation of Traditional Systems of Medicine and Homoeopathy in Bolivia, and will boost the importance of AYUSH (Ayurveda, Yoga, Unani, Siddha and Homoeopathy) systems of Medicine in Bolivia. The MoU will further facilitate exchange of experts for training for the practitioners and Scientists undertaking collaborative research, which will lead to new innovations in drug development and practice in Traditional Systems of Medicine.   ]]> https://biospectrumindia.com/news/22/13357/icmr-highlights-policy-implementation-gap-in-slt-control.html https://biospectrumindia.com/news/22/13357/icmr-highlights-policy-implementation-gap-in-slt-control.html Tue, 16 Apr 2019 09:00:00 +0530 A paper published on 4rth April, 2019 in the Lancet Oncology journal describes the extent of the policy implementation gap in smokeless tobacco (SLT) control, discusses its key reasons and makes recommendations to bridge this gap. Professor Ravi Mehrotra, Director of the National Institute of Cancer Prevention and Research (ICMR-NICPR), India and the lead author of the paper said “Smokeless tobacco use as a public health concern requires a comprehensive approach to deal with the challenges identified in the paper. In this regard, the WHO Framework Convention on Tobacco Control Global Knowledge Hub on Smokeless Tobacco (https://untobaccocontrol.org/kh/smokeless-tobacco/) at ICMR-NICPR is committed to assisting all countries in implementing the key recommendations from the paper.” Dr. Dhirendra Sinha from the School of Preventive Oncology (co-author) highlighted the global burden of SLT use and said that “smokeless tobacco kills over half a million adults worldwide”. Prof Balram Bhargava, Secretary, Department of Health Research, Government of India and Director General ICMR, New Delhi mentioned that, “Given the extent and multiple faces of SLT in India (almost 65% of the world SLT users are in India), the need of the hour is to undertake a national mission to fight SLT use by bringing together all stakeholders under one umbrella. In this regard, ICMR envisages a comprehensive and scientific approach to reduce the SLT burden of the country’, he added. ]]> https://biospectrumindia.com/news/22/13364/aimed-welcomes-dtabs-move-of-considering-to-regulate-all-medical-devices-.html https://biospectrumindia.com/news/22/13364/aimed-welcomes-dtabs-move-of-considering-to-regulate-all-medical-devices-.html Mon, 15 Apr 2019 11:45:00 +0530 DTAB has released the Minutes of the 82nd meeting of the Drugs Technical Advisory Board (DTAB) held on 02 April, 2019 at Nirman Bhawan, New Delhi. Rajiv Nath, Forum Coordinator of AIMED pointed out, “While we welcome the steps being taken by DTAB to consider to phase in Regulation of all medical devices however we notice with great concern that many key strategic aspects of the Road Map discussed with the Indian Medical Devices Industry Associations are missing and are not committed anywhere viz. : 1 - All Medical Devices need to be regulated under a separate Medical Devices specific Law  2 - Separate and Clear Regulations from Drugs required 3 - Representation on DTAB (Drugs Technical Advisory Board) by Medical Devices Industry nominees & regulatory expert as a special invitee till we have MTAB (Medical Devices Technical Advisory Board)  4 - Constitution of MD - EAG  (Medical Devices- Expert Advisory Group) to aid DTAB & MoH in Rolling out  medical devices regulations in a phased manner.”  DTAB in the meeting deliberated the matter and agreed to notify all medical devices as Drugs under the Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 and also to provide exemptions in the Rule 90 of the Medical Device Rules, 2017 during the transition period. The Board further agreed that CDSCO should be strengthened with respect to manpower and infrastructure to regulate all medical devices. The Board further recommended to include specialists like dentists and ophthalmologists in the category of experts to be recruited.  The Board also recommended that manpower and infrastructure in all States should also be strengthened and an advisory may be issued to all the States in this regard. Registration of all Manufacturers & Importers of all Non Notified Medical Devices at earliest on voluntary basis initially and then mandatory. Rajiv Nath said, “We request the Govt. to stick to earlier assurance given to the Industry by MOH&FW in 2016 of 4 steps - of starting with Medical Devices Rules (MDR), initially experimenting with a few Electronic Devices under MDR, MDR to be amended as per experience gained after 6 months of introduction and simultaneously draft Bill of a Medical Device Patient Safety Bill to be reviewed and passed by Parliament and the MDR to be tweaked to fit with eventual Medical Device Law.” “While we complement CDSCO & MoH&FW in listening to our requests to bring in a separate regulatory framework for medical devices independent of Drugs and carry forward the initial rolling out of regulations from the launch of Medical Devices Rules earlier in Jan 2018 to a logical conclusion and in a phased manner, but much more needs to be done and in a more planned manner in place of a piecemeal approach. We regret to note certain important strategic directions are missing. Thankfully a re-start of the process that had stalled has been made. Let’s hope MoH&FW will act stop procrastinating in the need to ensure patient safety and encourage domestic manufacturing that had been negatively impacted in absence of a predictable regulatory environment”, added Nath “It’s imperative to have a separate Law as Devices are engineering items and not medicines - an X Ray machine by no stretch of imagination can be called a Drug so continued attempts to regulate Devices as Drugs is illogical & incorrect. The Medical Devices Rules has risk proportionate controls correlating to risk classification of devices. Similarly the law and penal provisions need to be risk proportional as you can’t have the same penalty for a manufacturing failure of a spectacle as is for a contact lens or for a intraocular lens”, he also added. “Additionally we are all aware of the pitfalls in the current regulatory framework of Drugs that do not regulate the quality uniformly and equitably from state to state in absence of a central national singular regulatory authority and we don’t wish to fall under the same issues for Devices too. The DTAB meeting is silent on this and regretfully no representative of medical devices industry or a regulatory expert is invited to these important meetings that decide the fate of the industry.” In absence of regulatory approval a start and entrepreneur is challenged to prove his medical is safe to be used on patients and has good quality though the Quality Council of India does provide a voluntary certification scheme. There is an urgent need for an integrated and calibrated development policy to put ‘Make In India’ initiative in medical devices  sector in top gear, reduce high import dependency on foreign made devices in order to promote indigenous manufacturing of drugs and devices as a regulatory approval to an indigenous product will go a long way in making India a global robust hub for medical devices manufacturing and fulfilling Govt’s ambitious mission of making quality healthcare affordable for common masses” concluded Rajiv Nath.     ]]> https://biospectrumindia.com/news/22/13353/icmr-puts-emphasis-on-ethical-guidelines-for-biomedical-research.html https://biospectrumindia.com/news/22/13353/icmr-puts-emphasis-on-ethical-guidelines-for-biomedical-research.html Fri, 12 Apr 2019 15:40:00 +0530 Indian Council of Medical Research’s (ICMR) National Ethical Guidelines for Biomedical Research has become mandatory and needs to be adhered to for all biomedical research in the country as per the New Drugs and Clinical Trials Rules 2019 released recently by Ministry of Health and Family Welfare, Government of India. This will be effective after 180 days from the date of publication of Gazette. These details are included under clauses 15, 16, 17, 18 under Chapter IV of the New Drugs & Clinical Trial Rules. This is for the first time that biomedical and health research is going to be regulated through the ethics committees and the system is being set up by Ministry of Health and Family Welfare which has designated Department of Health Research, as the authority for registration of ethics committee that review such research and thereby help in safeguarding the safety, rights, welfare of research participants. The salient requirements are: Any institution or organization which intends to conduct biomedical and health research shall be required to have an Ethics Committee (EC) which has been constituted, functions and maintains records in accordance to ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017. ECs shall review the research before initiation and oversee throughout the duration of the research. The EC shall be required to register with the Authority and the registration would remain valid for a period of five years from the date of its issue, unless suspended or cancelled by the authority. The ICMR National Ethical Guidelines will guide the ethical requirements for all institution that are engaged in such research whether it is medical colleges, research institutions, universities, public or private funded institutions, non-governmental organisation or others. Dr. Balram Bhargava, Secretary, Department of Health Research and Director General, ICMR, stated “The inclusions of clauses to govern biomedical and health research in the New Drugs & Clinical trials Rules, 2019 will bring about the much needed transparency and accountability in the regulation of biomedical and health research in India. This would help to improve the quality of research outcomes while ensuring protection of research participants and responsiveness to the health needs of our people.” ]]> https://biospectrumindia.com/news/22/13323/scientific-convention-on-world-homoeopathy-day-.html https://biospectrumindia.com/news/22/13323/scientific-convention-on-world-homoeopathy-day-.html Wed, 10 Apr 2019 10:45:00 +0530 A two-day Convention on World Homeopathy Day was recently conducted in New Delhi The convention was inaugurated by Secretary, Ministry of AYUSH Dr. Vaidya Rajesh Kotecha. The World Homoeopathy Day is observed to commemorate the birth anniversary of the founder of Homoeopathy, Dr. Christian Fredrich Samuel Hahnemann. Dr. Kotecha in his inaugural address emphasised the Ministry’s efforts to bridge the gap between science and tradition through researches in the field of AYUSH.  He further said that the Ministry is equally dedicated to validate Homoeopathy through focused research, enhance its manufacturing and production standards, as well as assure the best quality education in the homoeopathy colleges.  On this occasion Joint Secretary, Ministry of AYUSH, Roshan Jaggi said that a link between the academic and research environments is an essential dimension to identify and evolve mechanisms of synergy between scientists and educators. Memoranda of Understanding (MOUs) were also exchanged with the Directorate of AYUSH Chandigarh administration on undertaking research on epidemic diseases like Dengue, Influenza like illness, Chikungunya, Tuberculosis and other infectious diseases and with JSPS Government Homeopathic Medical College, Ramanthapur, Hyderabad for undertaking clinical research . ]]> https://biospectrumindia.com/news/22/13318/dbt-cdsco-address-regulatory-concerns-of-innovators.html https://biospectrumindia.com/news/22/13318/dbt-cdsco-address-regulatory-concerns-of-innovators.html Tue, 09 Apr 2019 15:30:00 +0530 Department of Biotechnology (DBT) jointly with Central Drugs Standard Control Organisation (CDSCO) is organizing a national series of six regulatory workshops across the nation on facilitating resolution of regulatory concerns faced by the innovators in India. This workshop series is being conducted by the Biotechnology Industry Research Assistance Council (BIRAC) and Clinical Development Services Agency (CDSA). Two workshops in the series were conducted in New Delhi in December 2018 and Pune in February 2019. The third in this series was recently organised at the Centre for Cellular and Molecular Platforms (C-CAMP), Bengaluru. “C-CAMP is providing the necessary platform to the innovators so that they can share their doubts and questions directly with the regulators. We plan to start a portal soon where the innovators can drop in their questions for the regulators and we can mediate it further”, said Dr Taslimarif Saiyed, CEO & Director, C-CAMP. The workshop offered an opportunity to the innovators to interact with the regulators to resolve their regulatory issues thereby facilitating them to seek market authorization. Deliberations were done on various regulatory pathways applicable for the development of the new drugs, biopharmaceuticals, vaccines, medical devices & IVD kits, phytopharmaceuticals from discovery to commercialization. “The regulatory system is very much supportive towards the innovators. The regulatory pathways have been simplified and made clear. We are always open in addressing people’s doubts and concerns. The government is taking all possible measures for strengthening the regulatory system both at the central and state levels. A lot of questions are being asked nowadays about the regulations for e-pharmacies. The draft is ready from our side but the final decision is yet to be taken since the IDMA is not in favour ”, mentioned Dr B Kumar, Deputy Drugs Controller India, CDSCO, Sub Zonal Office, Bengaluru. During the workshop, Dr Sucheta Banerjee Kurundkar, Director Training, CDSA shared her views on how a communication gap at times exists between the innovators and regulators. “The government is keen on understanding the various concerns of the innovators. As a result, we are conducting these regulatory workshops through government organisations such as C-CAMP, ICGEB, Venture Center in order to reach out to the researchers and innovators. We have three more workshops lined up which are a part of this series. There are two sessions being organized at NIPER in Hyderabad and Guwahati, and one most probably in Baroda at MSU. We plan to do much more in this regard”, she said. The workshop was attended by a number of innovators, personnel working in the government national laboratories, academics and research institutions, participants from non-governmental institutions, startups, SMEs, MSMEs, industry, researchers. ]]> https://biospectrumindia.com/news/22/13283/health-ministry-forms-a-solidarity-human-chain.html https://biospectrumindia.com/news/22/13283/health-ministry-forms-a-solidarity-human-chain.html Fri, 05 Apr 2019 09:00:00 +0530 Ministry of Health and Family Welfare along with World Health Organization (WHO) has formed a Solidarity Human Chain as part of the World Health Day celebrations to reaffirm their commitment to bridging gaps and working collaboratively towards Universal Health Coverage (UHC). The theme of World Health Day 2019 is Universal Health Coverage: Everyone, Everywhere. Speaking at the function, Preeti Sudan, Secretary (Health) stated that this event emphasizes our commitment to ensure all people and communities have access to quality healthcare services, where and when they are required, without suffering financial hardship. At the event, Preeti Sudan also administered the solidarity pledge to work towards making universal health care available to everyone, everywhere.  Preeti Sudan said that the government is committed to strengthening 1,50,000 health facilities as Health and Wellness Centres which will deliver Comprehensive Primary Health Care closer to where people live in the rural and urban areas. “As of today, more than 17,000 HWCs are operational across the country and are providing services for non-communicable diseases in addition to existing services for reproductive and child health, communicable diseases etc,” she elaborated. World Health Organization Representative to India Dr. Henk Bekedam said, “A well-equipped primary health care delivery system is the key to achieving universal health coverage. This will require bringing quality care closer to people; strengthening peripheral health centres with linkages to secondary and tertiary care; and equipping primary health care providers to effectively deliver a package of preventive, promotive, curative and rehabilitative services. Let’s join hands to work on this.” ]]> https://biospectrumindia.com/news/22/13270/delhi-government-should-fix-margins-on-equitable-base-mtai.html https://biospectrumindia.com/news/22/13270/delhi-government-should-fix-margins-on-equitable-base-mtai.html Thu, 04 Apr 2019 09:00:00 +0530 The Delhi Government is working on a proposal to limit the mark-up on drugs and medical devices like consumables and implants to up to 50% over and above the procurement price for hospitals. Medical Technology Association of India (MTaI) in a statement said Delhi Government’s plan to curb prices of drugs and medical devices in hospitals will be effective if an equitable base is fixed to reach the acceptable margin of 50%. Pavan Choudary, MTaI Chairman and Director General said, “We appreciate the intention to curb profiteering in healthcare space. We support the mark-up of 50% over and above the procurement cost. The proposal should be implemented in compliance with the recommendations mentioned in the Report of The Committee of High Trade Margins in the Sale of Drugs, 2016 to create a level-playing field for all stakeholders including the medical device companies.” Pavan Choudary added, “We support undiluted implementation of the recommendations as that would provide for far greater affordability without compromising the industry’s ability to invest in innovation and training of healthcare professionals.” The Report of The Committee of High Trade Margins in the Sale of Drugs suggests that profit margin should be the difference between the Price to Trade (the price at which the manufacturer or marketing company sells the drug to the distributor or stockist) and the MRP. The report adds that “the government should consider capping the overall trade margins, thus, giving a level playing field to every trade channel”. ]]> https://biospectrumindia.com/news/22/13248/icmr-african-union-ink-mou-for-health-science-management.html https://biospectrumindia.com/news/22/13248/icmr-african-union-ink-mou-for-health-science-management.html Tue, 02 Apr 2019 11:50:00 +0530 Indian Council of Medical Research (ICMR), Ministry of Health and Family Welfare, Government of India recently signed an MoU with the African Union (AU) represented by Scientific Technical and Research Commission (AU-STRC) in New Delhi. The MoU will strengthen South-South collaboration in advancing health sciences research; enhance local capacity and ownership. Recognizing the common health challenges faced by limited public health resources the current initiative aspires to intensify cooperation and collaboration to develop cutting-edge, innovative and sustainable solutions catering to the health needs of respective regions of the globe. The programme would focus on training and strengthening capacity of health professionals, researchers, regulators and industry staff; support research collaborations for developing preventive tools and improved diagnostics for diseases which are regional priorities in India and Africa strengthening product development and manufacturing capacities for drugs and diagnostics. Dr. Balram Bhargava, Secretary DHR and DG, ICMR said that this MoU is a major step to help enrich global health research and stitch it to regional needs of India and Africa. The deliberations charted through series of discussions with leading experts will ensure advancements in strategic and multifaceted regional cooperation to optimize available resources towards contesting shared challenges in health sciences. ]]> https://biospectrumindia.com/news/22/13206/cabinet-approves-extension-of-biomedical-research-career-programme.html https://biospectrumindia.com/news/22/13206/cabinet-approves-extension-of-biomedical-research-career-programme.html Thu, 28 Mar 2019 09:00:00 +0530 The Union Cabinet, chaired by the Prime Minister Narendra Modi, has approved the continuation of the Biomedical Research Career Programme (BRCP), and Wellcome Trust (WT) /  DBT India Alliance beyond its initial 10-year term (2008-09 to 2018-29) to a new five year phase (2019-20 to 2023-24) with Department of Biotechnology (DBT) increasing its commitment to two times that of WT. The total financial implication will be Rs. 1092 crore with DBT and WT contributing Rs.728 crore and Rs.364 crore respectively. Over its 10 years of funding in a 1:1 partnership, the Programme has fulfilled its objectives of building and nurturing talent of highest global standards in cutting-edge biomedical research in India, which has led to important scientific breakthroughs and applications to meet societal needs. BRCP has made it attractive for high quality Indian scientists working abroad to return to India, and has increased the number of locations geographically within India where world-class biomedical research is undertaken. In the extending phase, the Programme would continue to build this capacity as also strengthen clinical research and work towards addressing important health challenges for India.  Continuation of the Programme with increased stake from the Government of India is important to bring about these returns. ]]> https://biospectrumindia.com/news/22/13200/dr-reddys-launches-tadalafil-tablets-usp-in-the-u-s-market.html https://biospectrumindia.com/news/22/13200/dr-reddys-launches-tadalafil-tablets-usp-in-the-u-s-market.html Wed, 27 Mar 2019 13:35:00 +0530 Dr. Reddy’s Laboratories Ltd. along with its subsidiaries together referred to as “Dr. Reddy’s” announced the launch of Tadalafil Tablets USP, a therapeutic equivalent generic version of Cialis (tadalafil) Tablets in the United States market, approved by the U.S. Food and Drug Administration (USFDA).  The Cialis brand and generic had U.S. sales of approximately $1.7 billion MAT for the most recent twelve months ending in January 2019 according to IMS Health.  Dr. Reddy’s Tadalafil Tablets are available in four strengths including 2.5 mg, 5 mg, 10 mg, and 20 mg, each in 30-count bottle size.  Cialis is a trademark of Eli Lilly and Company. ]]> https://biospectrumindia.com/news/22/13191/vp-calls-for-renewed-focus-on-rural-healthcare.html https://biospectrumindia.com/news/22/13191/vp-calls-for-renewed-focus-on-rural-healthcare.html Tue, 26 Mar 2019 15:55:00 +0530 The Vice President of India, M. Venkaiah Naidu has called for a renewed focus on rural health care and cautioned that the quality of healthcare being delivered cannot be determined by the price being paid.    Outlining some of the major challenges faced by healthcare sector such as the epidemiological transition being witnessed by India from communicable to non-communicable diseases, unequal access to healthcare and rising costs, Naidu said that a lot more needs to be done to ensure health security to our vast population. The Vice President observed that urban areas had four times as many medical practitioners compared to rural areas, and said that this rural urban divide had to be addressed on war footing.  Highlighting the importance of technology, the Vice President said that with technology, it was possible to reach millions of people across the country, providing better diagnosis and treatment by facilitating effective collaboration between healthcare workers. Expressing concern over the rising costs of providing medical services, Naidu opined that the integration of technological innovation with healthcare delivery will certainly help in lower healthcare delivery costs. He urged all educational institutions to invest a sizeable portion of their budget in research and development for the discovery and advancement of new technologies. Terming medical profession as a ‘mission’, Naidu said that healthcare practitioners would play a critical role in nation building by safeguard the health of this nation, enabling it for it to take its rightful place of leadership in the world. ‘Only a healthy nation cab be a wealthy nation’, he added. These thoughts were expressed by the Vice President while delivering the 13th Convocation Address of Pravara Institute of Medical Sciences, a Deemed University (PIMS-DU), in Loni, Maharashtra recently. ]]> https://biospectrumindia.com/news/22/13173/health-ministry-reiterates-commitment-to-tb-elimination.html https://biospectrumindia.com/news/22/13173/health-ministry-reiterates-commitment-to-tb-elimination.html Mon, 25 Mar 2019 10:20:00 +0530 The Ministry of Health & Family Welfare commemorated the World TB Day with a function to mark the occasion, and reiterated the commitment to eliminating TB in the country by 2025. Preeti Sudan, Health Secretary presided over the function. She stressed on the importance of more sensitive and responsive doctors, paramedics, frontline health workers and community partners, while dealing with TB patients. The systems of care for TB patients should be patient –centric, and sympathetic to their wellbeing, she emphasised. She stated that India has been able to free of Polio, Yaws, MNTE due to the sturdy health systems, especially at the primary healthcare levels. She stated that partnerships with all stakeholders hold the key to making India TB-free. She led the participants of the event to take a pledge to unite together to contribute and support towards making India TB free. Various presentations made at the event highlighted the key changes introduced in the policy landscape of TB in the country. India is now closest ever to covering all TB cases with 21.5 lakh new TB patients notified in 2018. With the aim of universal access to free diagnostics and treatment services, path breaking policy changes have been introduced. Universal drug susceptibility testing has been rolled out, shorter and newer treatment regimen has been expanded countrywide. India is moving towards an injection free regimen. TB champions from states shared their stories of overcoming the stigma of being a TB patient and motivating other patients to undergo the treatment. A special issue on TB of the Indian Journal of Tuberculosis and a toolkit on Patient Provider Support Agency were also unveiled at the function. Also present at the event were Sanjeeva Kumar, Additional Secretary & Director General (RNTCP & NACP), and senior officers of the Ministry, representatives from WHO and other development partners, community support organisations.   ]]> https://biospectrumindia.com/news/22/13119/cross-functional-collaboration-between-science-policy-research-and-data.html https://biospectrumindia.com/news/22/13119/cross-functional-collaboration-between-science-policy-research-and-data.html Mon, 18 Mar 2019 12:00:00 +0530 A panel discussion on ‘Leveraging Big Data to Inform Research and Improve Public Health Policy’was organised by NCAER, the Bill & Melinda Gates Foundation and Global Health Strategies in New Delhi recently. The discussion was held amid growing realization about the importance of using clinical, survey and administrative data for developing public health policies and shaping national health agendas.    The discussion, opened by Dr. Suneeta Krishnan, Country Lead, Measurement, Learning and Evaluation, Gates Foundation,began with key note addresses by Dr. Maurício Barreto, Executive Director, CIDACS, The Center for Data Integration and Knowledge for Health, Brazil and Dr. Anurag Agrawal, Director, CSIR Institute of Genomics & Integrative Biology who dwelt on the experiences of Brazil and India in the field of big data and its contributions to health policy reform.            Subsequently, leaders in the fields of public health research and policy discussed opportunities for multi sectoral collaborations and the need for building capacities for leveraging big data analysis. Panelists deliberated on the drivers of evidence use in public policy formulation in India. They underscored the importance of using research and administrative data analysis to identify policy priorities and suggest targeted use of available resources for improving health outcomes.    Alok Kumar, Adviser NITI Aayog, opined, “The need for cross-functional collaboration is now more than ever. As we grapple with new diseases and outbreaks globally, it is of utmost importance that science, policy, research and data are all viewed from the singular lens of informing public policy. Only then can we attain a comprehensive developmental and growth agenda”.   In this context, Ayushman Bharat -PM JAY was highlighted as a rich source of data, including for longitudinal analyses and identification of disease determinants and population impacts of policies.    “Traditionally data has been viewed from the colored vision of security breaches and impeachment of privacy. Before anything else we need to sensitise and reassure people about the prudent, careful and anonymised used of data generated from governmental initiatives and develop standardised procedures that ensure no misuse of such large amounts of information”, remarked Dr. Indu Bhushan, CEO, Ayushman Bharat. ]]> https://biospectrumindia.com/news/22/13123/niti-aayog-health-policy-experts-call-for-better-leveraging-of-research-and-data-to-firm-up-policy-priorities.html https://biospectrumindia.com/news/22/13123/niti-aayog-health-policy-experts-call-for-better-leveraging-of-research-and-data-to-firm-up-policy-priorities.html Mon, 18 Mar 2019 10:35:00 +0530 A panel discussion on ‘Leveraging Big Data to Inform Research and Improve Public Health Policy’ was organised by NCAER, the Bill & Melinda Gates Foundation and Global Health Strategies in New Delhi yesterday. The discussion was held amid growing realization about the importance of using clinical, survey and administrative data for developing public health policies and shaping national health agendas.  The discussion, opened by Dr. Suneeta Krishnan, Country Lead, Measurement, Learning and Evaluation, Gates Foundation, began with key note addresses by Dr. Maurício Barreto, Executive Director, CIDACS, The Center for Data Integration and Knowledge for Health, Brazil and Dr. Anurag Agrawal, Director CSIR Institute of Genomics & Integrative Biology who dwelt on the experiences of Brazil and India in the field of big data and its contributions to health policy reform.          Alok Kumar, Adviser NITI Aayog, opined, “The need for cross-functional collaboration is now more than ever. As we grapple with new diseases and outbreaks globally, it is of utmost importance that science, policy, research and data are all viewed from the singular lens of informing public policy. Only then can we attain a comprehensive developmental and growth agenda”. In this context, Ayushman Bharat -PM JAY was highlighted as a rich source of data, including for longitudinal analyses and identification of disease determinants and population impacts of policies.  Dr. Indu Bhushan, CEO, Ayushman Bharat said, “Traditionally data has been viewed from the colored vision of security breaches and impeachment of privacy. Before anything else we need to sensitise and reassure people about the prudent, careful and anonymised used of data generated from governmental initiatives and develop standardised procedures that ensure no misuse of such large amounts of information.” Dr. Shekhar Shah, Director-General NCAER, stated, “The large volume of clinical data generated by the scheme, if suitably anonymised, can be used to develop targeted, cost-effective public health programmes. The data will also help researchers in analysing disease outbreaks, causes and plausible measures for mitigation. We are sitting on a pile of gold, waiting to be used.”  Dr. Shinjini Bhatnagar, Dean (clinical research) THSTI, elucidated, “The strategy should be to encourage discovery/research that is inspired by societal need and innovation which is driven by new knowledge in order to create applications that can go back to the society”.  C N Raghupathi, Head, India Business Infosys, explained, “Data, strategy, security and policy reform together form a tight rope that is difficult to walk on. Data- driven policies are an ideal and utopian vision, but in reality, the execution becomes muddy. However, that should not deter us from working continuously towards accomplishing the vision we have in mind”.   Dr. Henk Bekedam, WHO Representative to India, noted, “Digital health is a core element of WHO’s new organizational structure and an important agent for advancing public health. WHO is committed to working with countries to accelerate the use of digital health interventions in advancing the efforts to strengthen primary healthcare, universal health coverage and health-related sustainable development goals.”  Leaders in the fields of public health research and policy discussed opportunities for multi sectoral collaborations and the need for building capacities for leveraging big data analysis. Panelists deliberated on the drivers of evidence use in public policy formulation in India. They underscored the importance of using research and administrative data analysis to identify policy priorities and suggest targeted use of available resources for improving health outcomes.      ]]> https://biospectrumindia.com/news/22/13059/new-roadmap-for-medical-device-regulation-raises-concerns.html https://biospectrumindia.com/news/22/13059/new-roadmap-for-medical-device-regulation-raises-concerns.html Mon, 11 Mar 2019 14:30:00 +0530 In a recent development, the Union Health Ministry notified 8 more medical devices categories including the entire range of implantable devices as drugs— all implantable devices, MRI equipment, PET, bone marrow separators, dialysis machines, CT Scan and defibrillators. Ironically, the notification comes at a time when the medical industry in the country was hoping for a separate regulatory framework for devices. All set to come into effect from April 2020, the decision has left the healthcare experts questioning the approach behind the move. “This sends confused messages to the public and healthcare community as we were expecting a separate regulatory act for devices. While I agree that the Central Drugs Standard Control Organisation has substantial experience in regulating this healthcare, but we need a scientific approach to regulatory issues particularly for devices which are engineering-driven products and not chemical entities like drugs. You cannot ensure patient safety by putting drugs and devices under the same regulations? The notice lacks clarity. Is an implantable device the same as a medicine?” said Dr B B Chanana, Head of Department Interventional Cardiologist, Maharaja Agrasen Super Specialty Hospital. Others question if a regulatory mechanism for drugs can “also” be the yardstick for the safety and efficacy of medical devices. “It is not just an issue of which word we use. The usage of drugs and equipment are completely different. Medical devices and pharmaceuticals vary in their development, evolution, manufacturing, method of delivery, and impact on patients. Each one of these devices has a unique functionality. An implantable device cannot be treated the same as a drug. You cannot have both under the same banner. This will not help patients but risk their lives even more,” said Dr. Tejinder Kataria, Chairperson Radiation Oncology, Cancer Institute Medanta - The Medicity. The medical experts argue the move will do little to improve the condition of the already “unregulated” medical device sector in India.  “Let’s not forget that India imports a major share of its medical devices. We use regulations on these devices as per international standards, or as instructed. Now, when you call a medical device a drug, the approval on its use and regulation becomes complicated. They cannot be under the same roof,” said Mohammad Ameel, Senior Consultant, Healthcare Technologies WHO CC for Priority Medical Devices & Health Technology Policy, National Health Systems Resource Centre, Ministry of Health & Family Welfare, Govt. of India. In fact, the Minister of Chemicals and Fertilisers, D V Sadananda Gowda, at the 'India Pharma and Medical Device 2019' conference in Bangalore also pointed out, “The government is cognisant of the fact that medical devices must be identified as separate from pharmaceuticals for all purposes relating to business, policy and regulations.” India has long ignored the need to recognize medical equipment as a separate vertical. With the new notification on the table, the question is— where are we headed with the regulation of some of the most significant devices in the medical industry? Also, are they the same as drugs?   ]]> https://biospectrumindia.com/news/22/13033/cabinet-approves-continuation-of-aids-programme-.html https://biospectrumindia.com/news/22/13033/cabinet-approves-continuation-of-aids-programme-.html Fri, 08 Mar 2019 13:10:00 +0530 The Cabinet Committee on Economic Affairs chaired by the Prime Minister has given its approval for continuation of National AIDS Control Programme-IV (NACP-IV) beyond 12th Five Year Plan for a period of three years from April, 2017 to March, 2020. The total outlay will be Rs.6434.76 crore. The programme is aiming: More than 99% of population will be kept HIV free. More than 70 lakh of key population covered annually through a comprehensive HIV prevention programme. Around 15 crore of vulnerable population (including five crore pregnant women) will be tested for HIV in three years of project. Two crore 32 lakh units of blood will be collected at NACO’s supported blood banks during three year of project. Two crore 82 lakh episodes of sexually transmitted infections will be managed under project during three years of project. Seventeen lakh of PLHIV will be put on free anti-retroviral treatment by end of project period. ]]> https://biospectrumindia.com/news/22/13024/cabinet-approves-uk-india-cancer-initiative.html https://biospectrumindia.com/news/22/13024/cabinet-approves-uk-india-cancer-initiative.html Thu, 07 Mar 2019 15:05:00 +0530 The Union Cabinet chaired by Prime Minister Narendra Modi has approved the Memorandum of Understanding (MoU) signed last year between India and U.K. on Cancer Research Initiative. The India-UK Cancer Research Initiative will identify a core set of research challenges that address issues of affordability, prevention and care of cancer by bringing together leading Indian and UK experts across clinical research, demographic research, new technologies and physical sciences. The initiative will provide funding to develop new research alliances and undertake impactful research to enable significant progress against cancer outcomes. The India-UK Cancer Research Initiative is a collaborative 5-year bilateral research initiative by the Department of Biotechnology (DBT), Ministry of Science & Technology, India and Cancer Research UK (CRUK) that will focus on affordable approaches to cancer. Both CRUK and DBT will invest £5 million (approx. 45 crores) each in this 5-year pilot, and seek further investment from other potential funding partners. ]]> https://biospectrumindia.com/news/22/12987/cabinet-approves-setting-up-of-new-aiims-at-manethi-haryana.html https://biospectrumindia.com/news/22/12987/cabinet-approves-setting-up-of-new-aiims-at-manethi-haryana.html Mon, 04 Mar 2019 12:45:00 +0530 The Union Cabinet, chaired by the Prime Minister Narendra Modi, has given its approval to the establishment of new All India Institute of Medical Sciences (AIIMS) at Manethi, District Rewari, Haryana New AIIMS will add 100 UG (MBBS) seats and 60 B.Sc (Nursing) seats. It will have 15-20 Super Specialty Departments and will add around 750 hospital beds. As per data of current functional AIIMS, it is expected that each new AIIMS would cater to around 1500 OPD patients per day and around 1000 IPD patients per month. Establishment of new AIIMS involves creation of Hospital, Teaching Block for medical & nursing courses, residential complex and allied facilities/services, broadly on the pattern of AIIMS, New Delhi and other six new AIIMS taken up under Phase-I of PMSSY. Government’s objective is to establish the new AIIMS as Institutions of National Importance for providing quality tertiary healthcare, medical education, nursing education and research in the Region.   ]]> https://biospectrumindia.com/news/22/12965/cabinet-approves-mou-between-india-and-argentina-in-the-field-of-medical-products-regulation.html https://biospectrumindia.com/news/22/12965/cabinet-approves-mou-between-india-and-argentina-in-the-field-of-medical-products-regulation.html Fri, 01 Mar 2019 09:35:00 +0530 The Union cabinet chaired by the Prime Minister Narendra Modi has given ex-post facto approval to the MoU between India and Argentina on cooperation in the field of Medical Products Regulation. The approval would facilitate better understanding of the regulatory aspects between the two sides and help in increasing India’s export of medical products to Argentina and better coordination in the international fora. ]]> https://biospectrumindia.com/news/22/12963/significant-reduction-in-cancer-drug-prices.html https://biospectrumindia.com/news/22/12963/significant-reduction-in-cancer-drug-prices.html Fri, 01 Mar 2019 09:00:00 +0530 The National Pharmaceutical Pricing Authority (NPPA), in a recent meeting, invoked extraordinary powers in public interest, under Para 19 of the Drugs (Prices Control) Order, 2013 to bring 42 non-scheduled anti-cancer drugs under price control, through Trade Margin Rationalisation. So far, 57 anti-cancer drugs are already under price control as scheduled formulations.  42 non-scheduled anti-cancer medicines have now been selected for price regulation by restricting trade margin on the selling price (MRP) up to 30%.  These would cover 72 formulations and 355 brands as per data available with NPPA.  More data is being collected from hospitals and manufacturers to finalise the list.   The manufacturers have been given seven days to recalculate the prices and inform the NPPA, State Drug Controllers, stockists and retailers.  The revised prices shall come into effect from 8thMarch, 2019. As per data available with NPPA, the MRP for 105 brands will be reduced up to 85%. An approximate estimate is that after taking into account the combination drugs too, there will be a minimum saving of Rs. 200 crore per annum to cancer patients on account of this intervention.         Dr. BS Ajaikumar, Chairman & CEO of Healthcare Global Enterprises points out, “The Government’s move to provide relief to cancer patients regarding treatment costs is welcome but while it may appear to benefit the patients momentarily, it will be detrimental to them in the long run. We need to encourage cashless treatments and strive towards implementing universal healthcare for all sections of the society, irrespective of rich or poor providing quality healthcare to everyone. The government should also improve the per capita income of the citizens of this country as one percent of the population cannot control 80 percent of the wealth. There should be better distribution of income and purchasing power, so that people can have access to products with the right price and get quality treatment at the right time. This will lead to better patient safety, good outcome, and India could be the leader in research and development in the medical field.” ]]> https://biospectrumindia.com/news/22/12945/dbt-celebrates-33rd-foundation-day.html https://biospectrumindia.com/news/22/12945/dbt-celebrates-33rd-foundation-day.html Wed, 27 Feb 2019 10:05:00 +0530 Department of Biotechnology celebrated its 33rd Foundation Day on 26th Feb in New Delhi with the theme as "Celebrating Biotechnology: Building Indian as an Innovation Nation". On the occasion Dr. Harsh Vardhan, Union Minister for Science & Technology gave away the Biotechnology Research Innovation and Technology Excellence (BRITE) awards. The Union Minister emphasized the role of Department of Biotechnology during the last 33 years in creating a large scale impact across the multiple sectors by development and commercialization of affordable solutions for healthcare, improved crop varieties, animal diagnostics and technology for generation of clean energy. Further, he highlighted the progress made in the area of capacity building, generation of new knowledge, translational research and in nurturing of Biotechnology startup ecosystem. The Minister announced key missions at the foundation day ceremony including Atal JaiAnusandhan Biotech Mission - Undertaking Nationally Relevant Technology Innovation (UNaTI), which is expected to transform Health, Agriculture and Energy sectors during the next 5 years. This mission includes GARBH-ini- A Mission to promote Maternal and Child Health and develop prediction tools for pre-term berth, IndCEPI- A Mission to develop affordable vaccines for endemic diseases, Development of Biofortified and Protein Rich wheat - contributing to POSHAN Abhiyan, Mission on Anti Microbial Resistance for Affordable Diagnostics and Therapeutics and Clean Energy Mission - Innovative Technology interventions for Swachh Bharat. Dr. Harsh Vardhan further informed that the Department has recently established Skill Development Centers at various institutions and also collaborated with State Council of Science and Technology for implementation of Skill Vigyan programme which aims to provide high quality hands on training in tools and techniques in multidisciplinary area of biotechnology for entry level students. On the occasion, the Union Minister also unveiled short film on DBT activities, launched new DBT website and released Coffee Table book. The Science & Technology Minister also highlighted that Discovery research and generation of new knowledge of biological sciences is very important and is fundamental and foundation of innovation and Department's support to competitive R&D activities in biotechnology has resulted in more than 6000 publications. Dr. Renu Swarup, Secretary, DBT in her opening address laid impetus on strengthening the research and translation base and ensuring sustainability and scalability. The Secretary highlighted the role of (BIRAC) in promoting and nurturing innovation and entrepreneurship over the years which has resulted in support to more than 500 startups, 35 bioincubators spread across the country. “Approximately 175 IPs have been generated and 140 products and technologies commercialized; besides this, the Department has supported more than 15000 scientists and 5000 skilled research manpower.” said Dr. Swarup. On this occasion, Foundation Day lecture was delivered by Dr. Peter Goodhand, Chief Executive Officer, Global Allliance for Genomics and Health, Canada which was followed by panel discussion on Biotechnology @2025: Our Achievements; Our Aspirations and Young Investigators shared their scientific journey. Former Secretary, Dr. Manju Sharma also delivered a talk on celebrating Biotechnology "Building India as an Innovation Nation”.   ]]> https://biospectrumindia.com/news/22/12928/telangana-govt-launches-vaccine-skilling-programme-at-bioasia-2019-.html https://biospectrumindia.com/news/22/12928/telangana-govt-launches-vaccine-skilling-programme-at-bioasia-2019-.html Mon, 25 Feb 2019 22:05:00 +0530 With the intent to strengthen a robust ecosystem for Lifesciences, Biotech, Healthcare enterprises, Telangana State Governor, E S L Narasimhan inaugurated the 3-day 16th Edition BioAsia 2019 – Asia’s largest Biotechnology and Life-sciences forum to be held in Hyderabad from February 25th to 27th, 2019. Bearing the theme “Life Sciences 4.0 – Disrupt the Disruption”, BioAsia 2019, annual flagship event of the Government of Telangana, is focused on healthcare being re-imagined as a result of technological disruption. The event has over the years emerged as the most preeminent technology and bio-business convention in Asia for Life sciences, pharmaceuticals and healthcare. E S L Narasimhan, Telangana State Governor also launched the Vaccine Skilling Program of Telangana Government to promote skilled professionals and help the industry grow. One of its kind in the country, in the 1st stage of 30 students have been selected who will be put into a 100 Hours training program on the vaccines and biologics. The students will be trained by TASK and will be absorbed into the fast-growing industry with high demand for skilled workforce post successful completion of their training. During the inauguration, the organizing committee of BioAsia 2019 presented the prestigious Genome Valley Excellence Award 2019 to Dr. Don W. Cleveland of the University of California. This award is in recognition of the pioneering work he has done in cancer genetics. He is also the winner of the Breakthrough Prize for Life Sciences 2018, which is regarded as the “Oscar of Science”. “Over the years, BioAsia has been instrumental in promoting India as a key player in the global healthcare, life sciences and biotechnology industries. At this eminent platform, I am happy and privileged to announce Telangana Life Sciences Grid, through which the state government of Telangana intend to deliver its extensive support for every individual in life science sector in every aspect ranging from capital, infrastructure, government approvals, improving skills and expanding connects. We are glad that this initiative is first in its kind that will enable life sciences sector to achieve its $100-billion potential in accelerated mode. Over the course of next six months, we will form focussed working groups and prepare the detailed strategy for the Telangana life sciences grid,” said Mr. Jayesh Ranjan, Principle Secretary - Industries & Commerce & IT, Govt of Telangana.    Post the inaugural session, the Governor inaugurated the international exhibition wherein around a number of Corporates and 75 selected start-ups are exhibiting their innovative works and developments from the field of technology, pharma and biotechnology over the 3 days. Commenting on the key aspects of this edition, Mr. Shakthi Nagappan, Director of Life Sciences, Govt. of Telangana and CEO, BioAsia said, “In its journey of 16 years, BioAsia has been the torchbearer of developments in the fields of Biotechnology and life sciences, not just in India but across the Asian region. With each passing year, BioAsia is growing in stature and size; and the presence of such stalwarts from across the World testifies this fact.” This edition will have participation of more than 1,700 delegates from Industry, Governmental Authorities, Academia and Start-ups representing over 50 countries with around 100 High profile speakers and 700 Corporates. The event will bring around 100  eminent speakers from across the globe, with some of the best minds and leaders from their fields, including Prof. Krishnamurthy Subramaniam, Chief Economic Advisor to Govt of India, Dr. Don Cleveland, Ludwig Cancer Research, Univ. of California, San Diego (Breakthrough Prize for Life Sciences 2018), Dr. Renu Swarup, Secretary, Department of Biotechnology, Government of India, Dr. S Eswara Reddy, DCGI, CDSCO, Mr. KT Rama Rao, Working President, TRS, Mr. Badhri Srinivasan - Head, Global Development Operations – Novartis, Mr. Kris Gopalakrishnan, Chairman, Axilor Ventures, Mr. Thomas Arista, Dy Director, US FDA, Mr. Kurt Stoeckli, President and Chief Scientific Officer, Glenmark Pharma, Mr. Glenn Saldanha, CMD, Glenmark Pharma, Mr. Satish Reddy, Chairman, Dr. Reddy's Laboratories, Ms. Karenann Terrell, Chief Digital and Technology Officer, GSK, UK, Mr. Peter Lee, Corporate Vice President, Microsoft Healthcare, USA, Mr. Atanu Roy, CIO, Sun Pharma and Ms. Sangita Reddy, Joint MD, Apollo Hospitals to name a few. ]]> https://biospectrumindia.com/news/22/12872/call-for-separate-regulations-for-medical-devices-and-otc-drugs.html https://biospectrumindia.com/news/22/12872/call-for-separate-regulations-for-medical-devices-and-otc-drugs.html Tue, 19 Feb 2019 19:20:00 +0530 The 4th International Conference on Pharmaceuticals and Medical Devices held in Bengaluru on 18th & 19th February witnessed the participation of drug regulators from over 30 countries including Russia, Kenya, the UK, Malaysia, Indonesia, Saudi Arabia and Uzbekistan, along with participation of Indian drug regulators from 15 states. The conference was organised by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers and Government of India jointly with the Federation of Indian Chambers of Commerce & Industry (FICCI).  Some of the issues discussed at the CEOs roundtable included development of separate medical device and over-the-counter (OTC) drug regulations act, early decision on implementation of trade margin rationalization, addressing the issue of Active Pharmaceutical Ingredients (APIs) price escalation imported from China,  incentivisation for innovation in the pharmaceutical and medical device sector, greater transparency in the functioning of National Pharmaceutical Pricing Authority (NPPA) and lastly, amendments by the Ministry of Consumer Affairs for allowing companies to utilise the mandatory CSR spending towards medicine donations into Jan Aushadhi or Ayushman Bharat scheme. Knowledge sessions were focused towards promoting innovative ecosystem in India for pharmaceutical industry, interaction with State Drug Controllers and CDSCO for facilitating ease of doing business, initiatives for import registration procedure to enable faster access to global market for the industry, WHO activities and plans related to the regulation of health technologies and enabling the industry to gear up for Ayushman Bharat, the most aspirational health scheme rolled out by the government. In his concluding remarks, Navdeep Rinwa, Joint Secretary, Department of Pharmaceutical, Government of India, mentioned how the government was prioritising the pharma and medical device sector in AI applications by bringing in task forces and other policies in place.   ]]> https://biospectrumindia.com/news/22/12857/india-argentina-sign-mou-in-pharma-.html https://biospectrumindia.com/news/22/12857/india-argentina-sign-mou-in-pharma-.html Tue, 19 Feb 2019 09:00:00 +0530 India and Argentina have signed a number of Memorandums of Understanding (MoU) during the recent visit of Argentina President Mauricio Macri to India.  Besides other, an MoU in pharmaceuticals has been signed between Central Drugs Standard Control Organisation (CDSCO), Government of India, and National Administration of Drugs, Food and Medical Technology, Argentina. The signing authorities included Jorge Faurie, Foreign Affairs Minister, Argentina and Rajyavardhan Singh Rathore,  MOS (IC)/I&B and Youth Affairs & Sports. ]]> https://biospectrumindia.com/news/22/12856/two-day-one-health-india-conference-inaugurated-in-new-delhi.html https://biospectrumindia.com/news/22/12856/two-day-one-health-india-conference-inaugurated-in-new-delhi.html Mon, 18 Feb 2019 17:40:00 +0530 Two day long One Health India Conference, 2019 was today inaugurated in New Delhi. The Department of Biotechnology (DBT), Ministry of Science and Technology in partnership with the Departments of Agriculture Research and Education (DARE) and Animal Husbandry, Dairying & Fisheries (DAHDF), Ministry of Agriculture & Farmers’ Welfare; the Departments of Health Research (DHR) and Health & Family Welfare (DHFW), Ministry of Health & Family Welfare, is hosting the “One Health India Conference”. The conference plans to launch India's new One Health Initiative which is an intersectoral approach to tackling the most urgent health threats in India as well as in low and middle income countries across South and South East Asia and Sub-Saharan Africa.  Inaugurating the conference Dr. Harsh Vardhan, Union Science & Technology Minister said, “subject matter “One Health” dealing with human and animal health together in interaction with the environment in an integrated manner is an urgent need for protecting the global health and secure livelihoods. To address One Health there is a need to have a collaborative, multisectoral and trans disciplinary approach for designing and implementing programmes, policies and legislation supported by basic and applied research.” India is among the top geographical hotspots where zoonotics diseases are major public health issue causing high burden of morbidity and mortality. High priority zoonotic diseases like Brucellosis have been emerged from Haryana to Goa, incidence and prevalence of occupational zoonotic disease like Anthrax have affected human health throughout. Similarly, Bovine tuberculosis (bTB) is a chronic disease of cattle that impacts productivity and represents a major public health threat and is considered endemic in India. Further, being among the highest bacterial disease burden in the world, antibiotics, therefore, have a critical role in limiting morbidity and morality and consequently Antimicrobial Resistance (AMR) has huge implications for India.   Speaking on Anti Microbial Resistance, Dr. Harsh Vardhan said that estimates of global antibiotic use in poultry, swine and cattle in 2010 indicate that India accounts for 3 percent of global consumption and is among the top consumers worldwide, along with China, the United States, Brazil and Germany. "Use of antibiotics in chickens, in particular, is expected to triple in India by 2030 and therefore it is important to regulate the use of antibiotics in animals as well as humans to tackle the issue. It is also important to monitor the presence of antibiotic residues in animal food products as their presence can give chance to microbes to acquire resistance.”, said Dr. Vardhan. The main objective of the conference is to formulate a roadmap for the response, preparedness, and management of current regional, national and global health challenges using a One Health collaborative approach. It is known that 60% of human diseases are of animal origin and many of them have developed resistance to major antibiotics in nature and share the ecosystems they live and infect animal and humans. Therefore, the conference deliberations are focused on identifying needs and opportunities and developing a strategy map to addressing major human and animal diseases of concern including Brucellosis, Tuberculosis, Anthrax, Antimicrobial Resistance (AMR), together with biosafety, biosecurity, burden of disease and inter-sectoral collaboration considerations. The conference is bringing together thought-leaders from India and around the globe, providing a platform for researchers, medical and veterinary practitioners, public and private sector stakeholders, and policymakers to integrate knowledge and identify needs and opportunities to better coordinate activities and address major human, animal, and environmental health challenges. The Bill & Melinda Gates Foundation, the Institute of Animal Health and Veterinary Biologicals (IAH&VB) of the Karnataka Veterinary and Animal Sciences University and The Pennsylvania State University, USA will be collaborating with the partners of the One Health Initiative.   ]]> https://biospectrumindia.com/news/22/12855/affordable-accessible-healthcare-a-government-priority-d-v-sadananda-gowda.html https://biospectrumindia.com/news/22/12855/affordable-accessible-healthcare-a-government-priority-d-v-sadananda-gowda.html Mon, 18 Feb 2019 17:35:00 +0530   The 4th International Conference on Pharmaceutical & Medical Device sector, being organised by the Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, along with Federation of Indian Chambers of Commerce & Industry (FICCI), kickstarted today. V. Sadananda Gowda, Union Minister for Chemicals & Fertilizers and Statistics & Programme Implementation, Government of India inaugurated the two-days event. "The Government’s focus is on improving access to affordable medical care and contribute to the National Health Protection Scheme, even as India continues to maintain its leadership position in manufacturing and supply of high quality generic medicines", he said. Mansukh L. Mandaviya, Minister of State for Chemicals & Fertilizers, Road Transport and Highways, Shipping, Government of India, while stressing on the development of infrastructure and affordable healthcare through initiatives like Ayushman Bharat, said that the Government was taking measures to make the Indian pharmaceutical sector a Rs. 3 lakh crore market. K J George, Minister for Large & Medium Scale Industries, Government of Karnataka, said that the state government plans to set up a special pharmaceuticals SEZ in Hassan and Pharma Parks in Bengaluru and Mangalore, which forms  a part of the Government of India’s aim of investing over USD 50 billion by 2025. "Considering the increased involvement of the Micro, Small & Medium Enterprises in the medical devices manufacturing sector, WHO will provide technical support to the sector to upgrade manufacturing standards", stated Dr Henk Bekedam, WHO Representative to India S Sridhar, Chairman, FICCI Pharma Committee pointed out that the industry believed in universal healthcare at affordable price for all Indian citizens, adding that this is a long term plan and requires a joint effort of the Government, industry and other stakeholders to collectively own this vision. Badhri Iyengar, Chairman, FICCI Medical Device Forum, said that it was important to look at having a unified healthcare regulator which could act as a bridge between the industry and the Government to create one window for facilitating business. Drug regulators from over 30 countries including Russia, Kenya, the UK, Malaysia, Indonesia, Saudi Arabia & Uzbekistan are participating in the event. The event also involves participation of drug regulators from 15 states across India. A FICCI-KPMG Knowledge Paper “Evolution to revolution: by use of Artificial Intelligence and Advanced Analytics in pharma” was also released at the event.   Award winners- India Medical Devices company of the Year- Poly Medicure India Pharma Leader of the Year- Akums Drugs & Pharmaceuticals India Pharma CSR Responsibility of the Year- Dr Reddy’s Laboratories India Pharma Innovation of the Year- Lupin India Pharma Swachhta Champion- Indian Drug Manufacturers' Association (IDMA) ]]> https://biospectrumindia.com/news/22/12824/new-viral-vaccine-manufacturing-unit-to-come-up-at-tn-.html https://biospectrumindia.com/news/22/12824/new-viral-vaccine-manufacturing-unit-to-come-up-at-tn-.html Thu, 14 Feb 2019 10:55:00 +0530 The Union Cabinet chaired by Prime Minister Narendra Modi has approved the Proposal for allotment of land measuring 30 acres to Pasteur Institute of India (PII) for establishment of New Viral Vaccine Manufacturing Unit at Coonoor, Tamil Nadu. The project entails production of Viral Vaccines (like TCA anti-Measles Vaccine, JE Vaccine etc.) and Anti Sera (like Anti Snake Venom and Anti Rabies Sera) at the PII, Coonoor. Land for the project will be transferred free of cost. Land used for the project will also be got changed by the Ministry of Health & FW from ‘Industrial’ to ‘Institutional’. The allotment of land will encourage the production of life-saving vaccines for children, to strengthen the vaccine security of the country, and would reduce the cost, besides providing import substitution as presently these are being imported. ]]> https://biospectrumindia.com/news/22/12798/conference-on-unani-medicine-organized-in-new-delhi.html https://biospectrumindia.com/news/22/12798/conference-on-unani-medicine-organized-in-new-delhi.html Tue, 12 Feb 2019 09:55:00 +0530 As a part of 3rd Unani Day celebration, two-day National Conference on Unani Medicine was organized by the Central Council for Research in Unani Medicine (CCRUM) in New Delhi. Theme of the conference was ‘Unani Medicine for Public Health’ While inaugurating the conference, Dr. Najma Heptulla, Governor of Manipur said, “Unani Medicine can offer the right solution for many health challenges we are facing due to lack of treatment of many diseases and paucity of resources.” Dr. Heptulla urged the Unani fraternity to progress and evolve with the changing times, adapt to new techniques of health research and contribute new approaches to health management. She informed that Manipur has the treasure of over 500 medicinal plants and invited the medical scientists to visit the state for research. Addressing the conference, Shripad Yesso Naik, Minister of State (IC) for AYUSH said, “Our efforts are focused to tap the real potential of AYUSH systems in imparting preventive, promotive and holistic healthcare to the people.” Paying tributes to Hakim Ajmal Khan, whose birth anniversary is celebrated as Unani Day on 11th February every year, he attributed him as humane, versatile genius, intensely committed, articulate and a remarkable combination of honesty, high idealism and professional skill. Highlighting the strengths of Unani Medicine and other AYUSH systems in his address, Mukhtar Abbas Naqvi, Union Minister for Minority Affairs said, “AYUSH systems are golden key to health and wellbeing and India is the strongest hub of Traditional Medicine which is one of the reasons medical tourism is flourishing in the country.” He stressed on Integration of Unani Medicine in Mainstream Healthcare in line with the government policies and initiatives for mainstreaming of AYUSH in national healthcare. Speaking on the occasion, Dr. Jitendra Singh, Minister of State (IC), Ministry of Development of North Eastern Region, elaborated the present day threats to public health and how capable Unani Medicine has been in aptly maintaining public health. He also expressed his hope that Unani Medicine and other AYUSH systems will come forth to combat the current public health issues. Speaking on the occasion, Vaidya Rajesh Kotecha, Secretary to the Ministry of AYUSH urged to adapt Information Technology and informed about the steps taken by the Ministry of AYUSH in the form of National AYUSH Morbidity and Standardized Terminologies Electronic Portal (NAMASTE - PORTAL), initiative for incorporation of AYUSH Morbidity Codes in WHO – ICD 11, AYUSH Grid, use of Social Media and A-HMIS.  He made announcement for allotment of land and allocation of Rs. 250 crore for National Institute of Unani Medicine to be setup in Ghaziabad. On this occasion, AYUSH Awards for Unani Medicine were conferred on various Unani scientists and experts in recognition of their contributions for research, teaching and practice of Unani Medicine. The Best Research Paper Awards were presented to Dr. Arshiya Sultana, Associate Professor, National Institute of Unani Medicine, Bangalore for Clinical Research and Dr. Noman Anwar, Research Officer (Unani), Regional Research Institute of Unani Medicine, Chennai for Drug Research in Unani Medicine. The Young Scientist Awards were conferred on Dr. Jamal Akhtar, Research Officer (Unani) Scientist – III, CCRUM for Clinical Research and Dr. Nasreen Jahan, Associate Professor, National Institute of Unani Medicine, Bangalore for Drug Research in Unani Medicine. The Best Teacher Awards were presented to Prof. Tanzeel Ahmad, Aligarh Muslim University, Aligarh for Clinical Research, Prof. Mohd Aslam, Jamia Hamdard, New Delhi for Drug Research and Prof. Khalid Zaman Khan, Aligarh Muslim University, Aligarh for Literary Research in Unani Medicine. The Lifetime Achievement Awards were conferred on Prof. Naeem Ahmad Khan, Aligarh Muslim University, Aligarh and Prof. M A Jafri, Jamia Hamdard, New Delhi for Best Academician and Best Researcher in Unani Medicine respectively. The dignitaries released the Conference Souvenir and four other publications brought out by the CCRUM. The conference had dedicated sessions on Integration of Unani Medicine in Healthcare Delivery System, Management of Chronic Diseases, Public Health Programs, Unani Medicine for Geriatric Care and Mother and Child Healthcare, Quality Control in Traditional Medicine, Emerging Research Trends in Unani Medicine, and Way Forward for Globalization of Unani Medicine along with panel discussion on Challenges in Market Development for Unani Medicine – An Interface between Academia, Industry and Researchers. About 1300 delegates, resource persons, academicians, researchers and industry representatives are participated in the conference.   ]]> https://biospectrumindia.com/news/22/12790/venture-centre-organizes-workshop-on-regulatory-compliance-for-medical-products.html https://biospectrumindia.com/news/22/12790/venture-centre-organizes-workshop-on-regulatory-compliance-for-medical-products.html Mon, 11 Feb 2019 11:55:00 +0530 The Department of Biotechnology (DBT) and Central Drugs Standard Control Organisation (CDSCO) alongwith Biotechnology Industry Research Assistance Council (BIRAC) and Clinical Development Services Agency (CDSA) has organised with Venture Center, Pune a one-day interactive program,“National workshop on regulatory compliance for accelerating innovations”. This is one of the 6 national programs being planned across the nation. CDSA is a DBT organisation and it works with regulators (CDSCO) and innovators to facilitate the journey from ‘bench to bed side’ faster. Venture Center is working with various innovators, start-ups by providing all assistance like incubator facility, mentorship, funding support etc. Prime Minister had launched the Make in India initiative on September 25, 2014, with the primary goal of making India a global manufacturing hub. There are 25 sectors assigned in ‘Make in India’, biotechnology being one of them. This workshop aimed to facilitate "Make in India" drive by helping the innovators and offer an opportunity to the innovators to interact with the regulators to resolve their regulatory issues thereby facilitating them to seek market authorization.This series is planned as per the one of the recommendations of the inter-ministerial meeting at the NITI Aayog. First workshop of this series was organized on December 10, 2018at ICGEB, New Delhi.    The workshop was attended by senior representatives from Government organizations, academia, medical device industry, in vitro diagnostics, new drugs, biopharma, phytopharma representing various start-ups, hospitals, institutes etc. There were total 96 participants representing 67 institutes who attended this interactive meet. The faculties included senior experts, present and former regulators from CDSCO (Central Drugs Standard Control Organisation); BIS (Bureau of Indian Standards); CDSA, THSTI (Translational Health Science & Technology Institute); and NIB (National Institute of Biologicals). There were 3 major themes (medical devices; new drugs & phytopharma and biopharma) and all questions were addressed by the regulators. The other 4 programs in this national workshop series are envisaged at Bengaluru, Hyderabad; Guwahati and Vadodara in 2019.Such an attempt by various stakeholders to bring in facilitative platforms where innovators can meet regulators was hugely applauded by the attending participants.     ]]> https://biospectrumindia.com/news/22/12768/j-p-nadda-addresses-india-showcase-event-.html https://biospectrumindia.com/news/22/12768/j-p-nadda-addresses-india-showcase-event-.html Fri, 08 Feb 2019 10:15:00 +0530 A high level preparatory meeting for the sixth replenishment conference of the Global Fund is being hosted by India on 7th -8th February, 2019 in New Delhi. India is the first implementing country to host a replenishment milestone, which presents an unprecedented and unique opportunity to highlight India’s role and political leadership in global health, as well as its strong commitment to achieve SDG3. The Ministry of Health and Family Welfare is organizing “India Showcase” to highlight India’s global footprint in the field of innovation and technology to end AIDS, tuberculosis and malaria and its increased ownership of the national response and its growing role in development. J P Nadda, Union Minister of Health and Family Welfare recently inaugurated ‘India Showcase Event’ as part of the Preparatory Meeting of the Sixth Global Fund Replenishment. While inaugurating the same he said, “I am happy to share that the country has set an example globally by increasing its domestic financial allocations for health. India stands committed to increase its overall health allocations to 2.5% of its GDP as enunciated in the National Health Policy, 2017.” Ashwini Kumar Choubey, Minister of State (HFW); Dr. Vinod K Paul, Member, NITI Aayog; Preeti Sudan, Secretary (Health); Dr. Soumya Swaminathan, Deputy Director General of Programmes, WHO; Peter Sands, Executive Director, The Global Fund and Dr. Bilali Camara, Country Director, UNAIDS along with delegations and representatives from several countries were also present. Nadda further stated that this milestone meeting is in tandem with the vision of the Prime Minister who has given the clarion call to eliminate HIV/AIDS, TB and Malaria. “Under his guidance, we have continued our impactful strategies alongside path-breaking innovations to ensure high-impact programmes that improve health indicators and other determinants of wellness,” he emphasized. The Union Health Minister further said that India is prioritising resource allocations for Tuberculosis with more than 2 billion USD, being invested in the implementation of the National Strategic Plan to End TB 2017-2025. “This amount is separate from the additional amount of 100 million USD, being invested for nutritional support to TB patients under the Nikshay Poshan Yojna. As resolved by the Prime Minister at the End TB Summit, 2018 in New Delhi, the country is galvanising all efforts to End TB by 2025, five years ahead of the SDG target,” Minister added. He also said, “The Health Ministry is working to ensure smooth and sustained coordination among different departments and ministries to ensure a convergence of efforts to End TB by 2025. This inter-sectoral and multi-stakeholder approach has already demonstrated positive results on TB notifications in several states.” Nadda also highlighted the initiatives and achievements of the Government in HIV/AIDS and Malaria. He stated that the country has launched the National Strategic Plan on HIV/AIDS and Sexually Transmitted Infections (STI), 2017-24. “By 2024, the target is to ensure that 95% of HIV positive people in the country know their status, 95% of those who know their status are on treatment and 95% of those who are on treatment experience effective viral load suppression. Steps have been taken to ensure that there is no shortage of funds, drugs and testing kits,” he elaborated. He further said, “WHO world malaria report singled out India for its impressive gains against malaria. Among the high burden countries, only India showed a substantial decline in disease burden, with a 24% drop in cases. India is on course to meet the goal of ending malaria by 2030.” The Union Health Minister said that PM Jan Aarogya Yojana (PMJAY), a National Health Protection Scheme, which envisions health assurance of Rs. 5 lakhs per family per year, benefiting over 50crore people. “I am happy to share that since the roll-out of ‘Modicare’, in merely 135 days nearly 1.1 million people have already availed of the benefits worth RS. 15 Billion under the scheme,” he added. Ashwini Kumar Choubey reiterated the Government’s commitment to make India free of TB, Malaria and HIV/AIDS and emphasized on enhancing people’s awareness and people’s participation in eliminating them. He further stated that this platform will give an opportunity to share innovations that India has introduced on Health and specifically on HIV/AIDS, TB and Malaria. “By hosting this meeting, we exhibit the country’s commitment and political will to fight these diseases,” he added. Dr V K Paul stated, “India has made a paradigm shift in health systems strengthening through systems level changes and there is an urgent need to continue investing in systems along with new research and innovation.” India is in a sustained partnership with the Global Fund to fight against AIDS, Tuberculosis and Malaria (GFATM) since 2002 as recipient as well as donor. The Global Fund support has been instrumental in attaining targets related to HIV/AIDS, TB and Malaria reduction and escalating the fight against these three diseases. The Global Fund raises funds in multiyear cycles known as Replenishments and is preparing for sixth voluntary replenishment conference to mobilize needed resources to scale up life-saving programs over 2020-22.   ]]> https://biospectrumindia.com/news/22/12763/experts-meet-to-step-up-the-fight-against-malaria-and-drug-resistance.html https://biospectrumindia.com/news/22/12763/experts-meet-to-step-up-the-fight-against-malaria-and-drug-resistance.html Thu, 07 Feb 2019 17:05:00 +0530 The Asia Pacific Leaders’ Malaria Alliance (APLMA) convened a panel of senior officials in New Delhi to discuss the global fight to end malaria, outlining strategies to improve collaboration, increase investment and identify innovative approaches to eliminate the disease and stop drug-resistance. The event took place on the sidelines of the preparatory meeting for the Global Fund's Sixth Replenishment, hosted by the Government of India. Discussion centered on the alarming emergence of antimalarial drug resistance in countries of the Greater Mekong Subregion (GMS): Viet Nam, Myanmar, Cambodia, Lao PDR and Thailand. India remains susceptible to drug resistance as it lies in the middle of what is often referred to as the “world's malaria corridor” between the GMS and Africa. In the face of great progress, challenges like drug resistance can reverse collective efforts and put us off track from global malaria elimination. Last month, the Global Fund called on the world to “Step Up the Fight” against malaria, tuberculosis and AIDS with an aim to raise US$14 billion at its upcoming Sixth Replenishment meeting, which will be hosted by France in Lyon, in October 2019. “We need to double down on our efforts to eliminate malaria in the Mekong region and we need to do it quickly. The tools we have now are sharp and we have to use them more aggressively. We know that eventually resistance is going to blunt the tools to fight malaria,” said Peter Sands, Executive Director of the Global Fund. The Global Fund allocated US$359M to end malaria and drug resistance in the GMS from 2014 to 2020, which has to date led to a 43% decline in the number of malaria cases in the region and a rise of close to 200% in domestic investments to combat the disease. These efforts are funded by the Global Fund through a grant called the Regional Artemisinin-resistance Initiative Elimination (RAI2E). Moderating the panel, Dr. Ben Rolfe, Chief Executive Officer of APLMA, said, “Many countries in Asia Pacific have made significant strides in their efforts to eliminate malaria. This makes the rise of antimalarial resistance in the Mekong region a significant concern. In the face of progress and a declining caseload, we risk the emergence of complacency, which can allow challenges like drug resistance to percolate and spread to potentially devastating consequences. However, given the commitment and momentum I have seen today, I am confident that effective leadership, increased action, and innovation will bring us closer to the goal of elimination by 2030.” Melanie Renshaw, Interim Chief Programme Officer at the RBM Partnership to End Malaria, said, “To end malaria, we need global action supported by coordinated local efforts. Strong political commitment and sustained financial investments will help us maintain our gains and make new headway in our fight against malaria. The RAI2E has demonstrated how strategic investment and partnerships can yield success and serve as a model for efforts in other parts of the world.” Other prominent speakers at the event included H.E. Stephanie Seydoux, Ambassador for Global Health, France; Dr Neeraj Dhingra, Head of Malaria Division, National Vector Borne Diseases Control Programme, Ministry of Health and Family Welfare, India; Dr. Thandar Lwin, Deputy Director General, Department of Public Health, Ministry of Health and Sports, Myanmar; Dr. Arjen Dondorp, Chair, Regional Steering Committee (RSC), RAI2E; Sanne Wendes, Chief of Staff, Unitaid; and Dr. Dr Khuat Thi Hai Oanh, Center for Supporting Community Development Initiatives (Civil Society Platform for RAI2E). ]]> https://biospectrumindia.com/news/22/12749/cabinet-approves-india-brazil-collaboration-for-traditional-medicines.html https://biospectrumindia.com/news/22/12749/cabinet-approves-india-brazil-collaboration-for-traditional-medicines.html Thu, 07 Feb 2019 09:00:00 +0530 The Union Cabinet chaired by Prime Minister Narendra Modi has approved the Memorandum of Understanding (MoU) between India and Brazil on cooperation in the field of Traditional Systems of Medicine and Homoeopathy. The MoU will enhance bilateral cooperation between India and Brazil in the areas of Traditional Systems of Medicine. This will be of immense importance to both countries considering their shared cultural heritage. India is blessed with well-developed systems of traditional medicine including medicinal plants, which hold tremendous potential in the global health scenario. India and Brazil share a very close and multi-faceted relationship at bilateral level as well as in plurilateral for a such as BRICS, BASIC, G-20, G-4, BSA, and in the larger multilateral bodies such as the UN, WTO, UNESCO and Who. Brazil is one of the most important trading partners of India in the entire Latin America and Carribean region. Both India and Brazil are rich in biodiversity with a large range of health practices based on medicinal plants and history of use of traditional medicine. Ayurveda, Yoga and other traditional systems are popular in Brazil.   ]]> https://biospectrumindia.com/news/22/12734/government-reiterates-tb-elimination-target-of-2025.html https://biospectrumindia.com/news/22/12734/government-reiterates-tb-elimination-target-of-2025.html Wed, 06 Feb 2019 09:00:00 +0530 According to the Ministry of Health and Family Welfare, in 2018 year, 5, 36,752 TB patients have been notified from private sector. There has been 40% increase in TB notification from private sector as compared to 2017. 44,517 (8%) TB patients were given anti-TB drugs from the programme. As per State reports till 25.01.2019, 40% notified TB patients, 35% treatment supporters and 8% private practitioners have been paid incentives through DBT. The shortfall in stated targets, reasons thereof and strategies are as follows: A massive partnership with the private sector has been initiated as Joint Effort for Elimination of Tuberculosis (JEET) for the elimination of TB by 2025, five years ahead of the global schedule. Though the MoU was signed in March 2018, the project was launched in May 2018 and has picked up from October 2018. To increase in notification from private sector, public private support agency approach has been initiated in 85 districts from May 2018 onwards; Indian Medial Association has been engaged for large scale sensitization and advocacy with private practitioners with standardised digital material. States have been supplied anti-TB drugs to covering TB patients notified from private sector based on demand. States have been guided to keep programme provided anti-TB drugs at private practitioner’s clinic or pharmacy. Invalid or dormant bank accounts or holding of account in a branch which is yet to be integrated with PFMS (Public Finance Management System) are a few challenges being faced in scheme implementation. To overcome these issues and to ensure that beneficiaries of the schemes are not denied of DBT benefit, flexibility of providing the benefit through existing bank account of a blood relative has been given. States have also been advised to facilitate opening of zero balance accounts for TB patients, if necessary, under the PradhanMantri Jan DhanYojana (PMJDY) and Indian Postal Bank. ]]> https://biospectrumindia.com/news/22/12712/ashwini-kumar-choubey-chairs-6th-meeting-of-nhm.html https://biospectrumindia.com/news/22/12712/ashwini-kumar-choubey-chairs-6th-meeting-of-nhm.html Mon, 04 Feb 2019 12:35:00 +0530 The 6th meeting of the Mission Steering Group of the National Health Mission (NHM) was recently chaired by Ashwini Kumar Choubey, Minister of State for Health and Family Welfare. Speaking at the meeting, he said, “The Government is rapidly moving forward in providing Comprehensive Primary Health Care through Health and Wellness Centres (HWCs). I am happy to inform that about 8000 HWCs have become operational in 35 states / UTs.” Dr. V K Paul, Member (Health), NITI Aayog; Preeti Sudan, Secretary (HFW) and Manoj Jhalani, AS & MD (NHM), were also present at the meeting along with representatives from Ministries of AYUSH, Tribal Affairs, WCD, Drinking Water and Sanitation, Panchayati Raj, Rural Development, Urban development, Department of Higher Education, Social Justice and Empowerment and members from the civil society and other experts in the field of healthcare. “NHM is vital to supporting the states in improving their health systems. Prime Minister’s announcement of the heightened focus on the aspirational districts also provides us with significant leverage point to address long persisting inequities and development lag in these districts. This will be strengthened through NHM”, he added. It was highlighted that under NHM-Free Drug Service initiative, funds are being provided to states/UTs for provision of free drugs in public health facilities and setting up of IT-backed systems for drug procurement and quality assurance. Currently all 36 states have notified policy to provide essential drugs free of cost in public health facilities. Under NHM Free Diagnostics Service Initiative, substantial funding is provided to States within their resource envelope to provide free essential diagnostic services at public health facilities. The program has been rolled out in States/UTs which are providing free diagnostic Services either in-house or in PPP mode. The Minister stated that the meeting offered a valuable and useful platform for candid discussion on several issues, and a wider perspective from a wide section of experts which will enable to enhance quality and effectiveness of the NHM. He further added that the suggestions would be taken into consideration to guide the roadmap on interventions to be taken up. The MSG of the NHM discussed various agenda points including enhancement of reach, outlay and facilities within components of the NHM, Prevention and Control of Viral Hepatitis, Immunization, Comprehensive Primary Health Care, Non-Communicable Diseases (NCDs) Newer Intervention under Revised National TB Control Programme with respect to Patient’s Support and Private Sector Involvement, capacity building of health workers, etc. Many suggestions were also made by the non-official members of the MSG.     ]]> https://biospectrumindia.com/news/22/12689/inter-ministerial-committee-to-incentivise-research-quality.html https://biospectrumindia.com/news/22/12689/inter-ministerial-committee-to-incentivise-research-quality.html Fri, 01 Feb 2019 09:50:00 +0530 The government has announced that the fellowship of Ph.D students and other research personnel enrolled in any area of science and technology, including Physical and Chemical Sciences, Engineering, Mathematical Sciences, Agricultural Sciences, Life Sciences, Pharmacy etc.  has been enhanced with effect from January 1, 2019. Speaking at a press conference in New Delhi, Prof. Ashutosh Sharma, Secretary Department of Science &Technology (DST) said, “An Empowered Inter-Ministerial committee is to examine all the fellowship matters that have a bearing on enhancing the value, quality and experience of doctoral research, including the quantum of fellowship, which will not only widen the scope of training but also enhance the career prospects of research fellows.  The current hike announced yesterday will also be reviewed periodically, possibly annually, which is to be decided, by the empowered group that is being set up.” “There are various schemes to promote global exchange of researchers, including the Scheme called ‘VAJRA’-Visiting Advanced Joint Research Faculty Scheme. VAJRA is a dedicated program exclusively for overseas scientists and academicians with emphasis on Non-resident Indians (NRI) and Persons of Indian Origin (PIO) / Overseas Citizen of India (OCI) to work as adjunct / visiting faculty for a specific period of time in Indian Public funded academic and research institutions. The Scheme recognizes the value of collaborative research as a crucial element for information sharing among researchers for updating and acquiring knowledge and skills, and also to draw different perspectives to solve a shared problem”, he added. Joining him, Dr. Renu Swarup, Secretary, Department of Biotechnology and Dr. Shekhar C. Mande, Director General, CSIR and Secretary Department of Scientific & Industrial Research said, “The research fellowship is not a salary in career but is in the form of stipend while they are still in a career path which could lead to a great progress. They said there are several schemes now for researchers to go in for start-ups etc.” The hike in fellowship will directly benefit over 60,000 Research Fellows and also provide a template to the States to consider increase in their fellowship rates. Fellowship of the Junior Research Fellows in the first two years of Ph.D programme is increased from the current rate of Rs.25,000/- to Rs.31,000/- per month. Similarly, in the remaining tenure of Ph.D, Senior Research Fellow will get Rs. 35,000/- per month instead of the present Rs.28,000/- per month.    ]]> https://biospectrumindia.com/news/22/12676/preeti-sudan-inaugurates-capacity-building-workshop-for-mohfw.html https://biospectrumindia.com/news/22/12676/preeti-sudan-inaugurates-capacity-building-workshop-for-mohfw.html Thu, 31 Jan 2019 11:20:00 +0530 Preeti Sudan, Secretary (H&FW) recently inaugurated the three days Capacity Building Workshop for Regional Offices of Health & Family Welfare (ROHFWs) at Nirman Bhavan. She appreciated the role played by Regional Offices in coordinating with State Authorities especially in the most recent case of the Kerala floods in 2018. She said “Regional Directors must extend requisite technical support to state agencies in implementation of National Programmes and should focus of ROHFWs on operationalizing Health and Wellness Centres (HWCs) under Ayushman Bharat. Regional Directors should approach concerned authorities in States towards expediting posting of trained mid-level providers in all states.” She interacted with Regional Directors and asked them to involve themselves in State activities and become part of State conversations through State specific groups of the Ministry. While reviewing UP and Bihar, she advised the Regional Directors to work on containment of JE/AES and immunization in Uttar Pradesh; control and elimination of Kala-Azar in endemic districts of Bihar; and combating HIV/AIDS  in Nagaland. Dr. S. Venkatesh, DGHS was also present at the workshop. He highlighted the crucial role played by RoHFWs in the control of Nipah and Zika outbreaks in Kerala and Madhya Pradesh/Rajasthan respectively. He said “clarity in roles of Regional Directors is required for contributing effectively and efficiently to National Programmes and new initiatives of Ministry of Health & Family Welfare (MoHFW).” At present 19 ROHFWs are operational in the country for the past 40 years and there is requirement of 10 more offices for better work across the country.   ]]> https://biospectrumindia.com/news/22/12674/pm-inaugurates-state-of-the-art-hospital-in-surat.html https://biospectrumindia.com/news/22/12674/pm-inaugurates-state-of-the-art-hospital-in-surat.html Thu, 31 Jan 2019 11:00:00 +0530 The Prime Minister Narendra Modi has inaugurated state-of-the-art super specialty Rasilaben Sevantilal Shah Venus hospital in Surat. He expressed happiness that this hospital will also serve the people under the Ayushman Bharat Scheme.  Addressing a public gathering, PM said that his government is working for a healthy India. He mentioned, “The pro-poor steps taken by the government. He said that initiatives like Pradhan Mantri Surakshit Matritva Abhiyaan and Mission Indradhanush played a vital role in the decline in the mortality rate.” In a befitting reply to those who made a mockery of PM’s announcement of Swachta Abhiyan from the Red Fort, he said that today due to extensive sanitation drive, 97% population has access to clean toilets now. “Ayushman Bharat Scheme will create an entirely new ecosystem which helps to create healthier India. The scheme will boost set up of new hospitals in tier 2-3 cities, which also increases job opportunities in the healthcare sector, he added. More number of generic medicines are now available for the people which will not only reduce the cost of health care but also save many precious lives”, he added. PM also emphasized the importance of preventive health care and said the world has recognized the role of Yoga for wellness.    ]]> https://biospectrumindia.com/news/22/12617/pm-lays-foundation-stone-for-aiims-at-madurai.html https://biospectrumindia.com/news/22/12617/pm-lays-foundation-stone-for-aiims-at-madurai.html Mon, 28 Jan 2019 09:40:00 +0530 In a major boost to healthcare facilities and services in Madurai and adjoining areas of Tamil Nadu, the Prime Minister, Narendra Modi recently laid foundation stone for AIIMS Madurai. The new AIIMS will come up at Thoppur in Madurai. It will provide leadership in advanced healthcare, medical education and research in the region. This location will primarily benefit people residing in the Southern backward districts of Tamil Nadu. Addressing a gathering in Madurai, PM said “In some ways, the laying of foundation stone of the All India Institute of Medical Sciences at Madurai reflects our vision of Ek Bharat Shreshtha Bharat. AIIMS in Delhi has cultivated a brand name for itself in healthcare. With AIIMS in Madurai, we can say that this brand of healthcare has been taken to all corners of the country - from Kashmir to Madurai and from Guwahati to Gujarat. AIIMS at Madurai will benefit the entire population of Tamil Nadu.” Reiterating the emphasis of the Government on the health sector he said, “The idea is to ensure that everyone is healthy and health care is affordable. The speed and scale at which Mission Indra Dhanush is working is setting a new paradigm in preventive healthcare. Schemes such as Pradhan Mantri Matru Vandhana Yojana and Pradhan Mantri Surakshit Matritva Abhiyan is making Safe pregnancy a mass movement. The number of UG medical seats have been increased by 30% in the last four and half years.” About Ayushman Bharat he said, “it is a big step to ensure achievement of universal health coverage for the people. Prime Minister expressed satisfaction that 1 Crore 57 lakhs people from Tamil Nadu are covered under this scheme. PM lauded that in just over 3 months, about 89000 beneficiaries have benefited under this scheme and an amount of more than Rs. 200 Crore has been authorized for admitted patients of Tamil Nadu. I am happy to learn that Tamil Nadu has already started 1320 health and wellness centers.” On disease control front, he said Government is committed to the elimination of Tuberculosis by 2025 and added, “We are providing technical and financial support to states. I am happy to learn that state government is upscaling the TB free Chennai initiative and seeking to eliminate TB in the state by 2023 itself.” Prime Minister also inaugurated the super speciality blocs of Rajaji Medical College, Madurai, Thanjavur Medical College and Tirunelveli Medical College, as a part of Pradhan Mantri Swasthya Suraksha Yojana, which aims to upgrade 73 medical colleges across the country.   ]]> https://biospectrumindia.com/news/22/12597/pm-stiac-is-focusing-on-ambitious-scientific-projects-prof-vijayraghavan.html https://biospectrumindia.com/news/22/12597/pm-stiac-is-focusing-on-ambitious-scientific-projects-prof-vijayraghavan.html Fri, 25 Jan 2019 11:40:00 +0530 (L-R- Prof K VijayRaghavan- addressing the audience; seated dignitaries- Dr. Raja Mugasimangalam; Dr. Sudha N Rao; Dr. Samir K Brahmachari; Dr. Krishnamoorthy Kannan; Dr. PM Murali)   At the recently held two-days genomics conference Genomics India 2019 in Bengaluru, Prof K. VijayRaghavan, Principal Scientific Advisor to the Government, shared his thoughts on conducting big ambitious scientific projects in India. He mentioned that the newly formed 21-member advisory panel on science, technology and innovation called Prime Minister’s Science, Technology and Innovation Advisory Council (PM-STIAC) aims towards addressing this thought. “Our basic scientists in biology have not yet put in place a big ambitious project to work upon. Projects have usually been carried out at sub-optimal levels so far in India in the field of biology. Although the biotech industry in India has been doing exceedingly well, the amount of investment in research projects is very less. Industry investment in R&D barring few exceptions is not sufficient in our country. On the other hand, global companies such as Google and Amazon spend huge amounts on their R&D projects. This is not feasible with the Indian companies since there is no risk capital available. We need to mitigate the risk capital. This can be addressed if research laboratories work intricately with the industry and are able to translate the research thereafter. Also, the research environment at the laboratories in India has to be more flexible and less restricted. By giving more freedom to research, bigger projects can be carried out. PM-STIAC is in favour of going ahead with big ambitious projects such as genomics. We should move beyond our view point in genomics and understand it well. Conducting a genome project is a huge task which will involve sequencing, interpretation, genetic counseling and data privacy. There are also a lot of threats associated with sequence interpretation that needs to be conducted well. There is a huge complexity in relating genotype to phenotype. In order to go ahead with a genome project, a large number of genetic counselors would have to be trained. We need to understand that India has a huge population, and conducting a genome project will require a highly developed strategy. This could be developed as an ambitious project by the biologists in India”, Prof K VijayRaghavan said. Adding some more thoughts on the potential of genomics studies, Dr B S Ajai Kumar, Chairman, HealthCare Global Enterprises spoke on the clinical application of gene sequencing and other genomic related testing in oncology practice. He highlighted the approach of personalized medicine that allows doctors to select treatments to likely help patients based on a genetic understanding of their diseases. Even though researchers all over the world are making progress every day, the precision medicine approach to cancer treatment is not yet part of routine care for most patients. The Genomics India 2019 conference brought together renowned scientists on one platform in order to discuss the hold of genomics in crop research, plant protection, diseases such as cancer, diabetes, cardiometabolism, AMR, nutrient deficiency and much more. With a focus on sharing path breaking-research findings to indigenous products that address local needs, the conference provided insights into the advances in Genomic technologies and their novel applications in various fields. The conference offered unlimited opportunities for interactions with experts from academia, Startups industry, venture capitalists, government, profit and non-profit organizations of the biotech sector. ]]> https://biospectrumindia.com/news/22/12592/mohfw-announces-no-shortage-of-polio-vaccines.html https://biospectrumindia.com/news/22/12592/mohfw-announces-no-shortage-of-polio-vaccines.html Fri, 25 Jan 2019 10:30:00 +0530 There have been some reports regarding shortage of polio vaccine in India. According to the latest announcement by the Ministry of Health and Family Welfare (MoHFW), this is completely incorrect. There is no shortage of Oral Polio Vaccines (OPV) and Inactivated Polio Vaccine (IPV) in the country. As far as polio national immunization days (NID) is concerned, the required quantity of bivalent Oral Polio Vaccine (bOPV) has already been secured for the programme. However, to ensure availability of safe and quality vaccine to our children during NID, the testing of bOPV is made more stringent and the same will be dispatched to states for public use after the clearance from national testing laboratory for each batch and Polio NID will be held soon. Government has not postponed the NID indefinitely. Regarding Inactivated Polio Vaccine (IPV), there is neither shortage of IPV nor any shortage of funds for its procurement for Universal Immunization Programme (UIP) in the country. It is to be noted that India has eliminated polio already and as per global guidelines, introduced IPV in its Universal Immunization Program to safeguard the polio free status, as there are few countries where polio virus is still circulating and Polio is yet to be eliminated. All Gavi eligible countries are extended support for vaccines byGavi.Confronted with steep hike in prices of IPV, India approached Gavi for partial support for further procurements, as India is also a Gavi eligible country and the same has been agreed to by Gavi Board. ]]> https://biospectrumindia.com/news/22/12583/shripad-naik-inaugurates-2nd-world-integrated-medicine-forum-2019.html https://biospectrumindia.com/news/22/12583/shripad-naik-inaugurates-2nd-world-integrated-medicine-forum-2019.html Thu, 24 Jan 2019 10:35:00 +0530 The World Integrated Medicine Forum on the regulation of Homoeopathic Medicinal Products with the theme ‘Advancing Global Collaboration’ was inaugurated recently by Shripad Naik, Union Minister of State (I/C), Ministry of AYUSH. The three-day forum is being organised by Central Council for Research in Homeopathy (CCRH), with the support of Ministry of AYUSH, Homoeopathic Pharmacopoeia Convention of the United States (HPCUS) and European Coalition on Homeopathic & Anthroposophic Medicinal Products (ECHAMP), Pharmacopoeia Commission of Indian Medicine and Homoeopathy and Central Drugs Standard Control Organization (CDSCO). The forum has participation of key public and private sector stakeholders, such as representatives from World Health Organisation (WHO) and drug regulatory authorities, as well as pharmacopoeia experts and industrialists from countries like Germany, USA, France, UK, Brazil, Belgium, South Africa, Argentina, Russia, Greece, Austria, Cuba, Qatar, Croatia, Malaysia, Japan, Hongkong and Sri Lanka. Among the delegates are also present veterinary experts, as well as the regulators and drug controllers of various states of India. The Forum will be serving as the global platform in which the public and private sector can meet and exchange ideas on how to ensure and increase the availability of safe and effective homeopathic medicines worldwide, now for the second time. The first forum on similar lines was organised by CCRH in 2017. It is with the aim of brining the homoeopathic industry and regulatory sector on a common platform for strategic discussion that this ‘World Integrated Medicine Forum on the Regulation of Homeopathic Medicinal Products’ was initially conceived jointly by Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India and by World Integrated Medicine Forum (WIMF), an international firm that organises, and provides consultation for arranging such fora. Forum discussions will primarily explore the commonalities as well as differences in regulatory affairs among various countries, discuss strategic regulatory and industry perspectives and possible scenarios in advancing international collaboration, ways to further enhance pharmaceutical quality standards, deliberate on integrating Traditional Medicine systems in primary healthcare and public health, bring forth the perspectives on setting appropriate requirements on various dimensions of drug approvals including veterinary medicine. While appreciating the efforts for organising this forum, Shirpad Naik in his inaugural address remarked that, “India is the fifth largest investor in scientific research in Homoeopathy in the world. With the institutional support of more than 200 homoeopathic colleges and an autonomous Research Council having 26 research centres, Homoeopathic Pharmacopoeia Laboratory and a work force of about 250 thousand homoeopathic clinicians, India can contribute in various aspects of mainstream healthcare.” He called upon the industry as well as homoeopathic medical colleges to invest certain percentage of institutional and industrial revenues in research and collaborate with CCRH for undertaking high quality, cutting edge research projects. “The western medicine is today facing a huge challenge of management of non-communicable diseases which can be tackled by means of safer medicines. Excessive use of anti-biotics, pain-killers, anti-depressants, anti-hypertensive, statins, etc. are causing much harm to the society.  Homoeopathy, with its safe dosage can prove to be an effective alternative in such situations.  It has the potential to address non-communicable diseases by appropriately treating patients holistically in the initial stages and can also reduce the usage of these drugs”, he added. Union Minister further apprised, “The audience of the recent amendments in the Drugs & Cosmetics Rules 1945, which included freedom from requisition of separate license for a homoeopathy retailer for exhibiting the Homoeopathic Drugs for promotional activities in any fair, exhibitions etc. This would promote awareness and usefulness of homoeopathic medicines at wider public platforms. Another amendment that he informed the delegates about is the provision of sale of homoeopathic medicine from an allopathic counter. A licensee of allopathic drugs’ sales can sell homoeopathic medicines without any need of a separate license. This will make homoeopathic medicines more widely and easily available in India.” Minister further complimented the actions taken by the Joint Working Group comprising of Homoeopathic Pharmacopoeia Convention of the United States (HPCUS), Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) and CCRH based on the tripartite MoU signed by these bodies in the last forum, the most eminent one being successful harmonisation of 50 drugs in the American and Indian Homoeopathic Pharmacopeia. He hoped the successful outcomes of this agreement can be a benchmark for many more agreements to follow with the aim to develop and harmonise homoeopathic pharmacopoeias and to strengthen and enable regulatory provisions for homoeopathy worldwide. In his address, Roshan Jaggi, Joint Secretary, Ministry of AYUSH, complimented the theme of the forum, Advancing Global Collaborations, which, he said, was multidimensional and needed tremendous joint efforts. He said that, “Ministry of AYUSH welcomed all efforts for collaborations with the governments and other institutes of the world at various levels. The main components of the International Collaboration scheme of Ministry of AYUSH, which included providing incentive to drug manufacturers, entrepreneurs, AYUSH institutions etc. for registration of AYUSH products (Market Authorisation) at regulatory bodies of different countries such as USFDA/EMEA/UK-MHRA/ NHPD/ TGA etc. for exports.” He further informed that, “The Ministry also encourages international propagation of AYUSH by participating in international exhibitions, trade fairs, road shows etc. and support other international market development and AYUSH promotion-related activities. CCRH for actively collaborating internationally for various joint projects for research and cooperation in the field of Homoeopathy.” In a brief talk, Dr Hélène Renoux from France, President of the European Committee for Homeopathy, presented her views on the Homoeopathy Profession’s expectations from regulators and industry. She informed that there is a strong demand from patients for homeopathy from all over Europe, with 74% patients not only supporting the use of Homoeopathy, but also in favour of it continuing to be covered under social healthcare. She further said that, “The EU model of regulation of homeopathic medicinal products is actually a defence barrier, and its enforcement needs to be enhanced. She also looked at the efforts for harmonisation of pharmacopoeias as a positive move, which would help including remedies from each other’s pharmacopoeias.” Dr. Robbert van Haselen, Director, World Integrated Medicine Forum (WIMF), in his keynote address, mentioned that, “AIMF aimed to further develop evidence-based Traditional, Complementary and Integrated systems of Medicine (TCIM) by promoting public-private co-operation, where the public and private sectors are the ‘actors’, while patients and health care providers are the ‘drivers’. The legitimate and increasing demand/need for homeopathic products by patients and health care providers worldwide needs to be balanced by appropriate regulatory framework which proportionally addresses quality, safety, effectiveness and availability of medicines.” “To achieve this, the role of regulators, industry and respective countries are intertwined. He said that India is the rightful host to such a forum, given its openness to medical pluralism, both politically and culturally”, he added. Dr. Raj K. Manchanda, Director General, CCRH in his welcome address, expressed his gratitude to the Minister of AYUSH for his support and presence, welcomed all international and national guests and delegates to the forum, and also shared the outcomes of the last forum. He added that, “The core aim of the forum is to sensitise more and more stakeholders to the needs and challenges of regulating HMPs, by providing an appropriate stage to discuss such issues, and not to enforce or impose what is deliberated. He said that since each country is unique, accordingly, its regulatory designs for HMPs can best be decided by the direct stakeholders.” More than a billion patients worldwide are demanding safe and effective medicines for their healthcare. As a result, the demand for Homoeopathy is growing. There is still a highly disparate situation among countries with regard to the regulations of homeopathic medicines and this directly affects the availability of these medicines. Apart from illustrating how homeopathy can be further regulated and integrated into the healthcare system in countries that have adopted the use of Homoeopathy since long, this Forum will also bring countries to the table where homeopathy has only been recently introduced.   ]]> https://biospectrumindia.com/news/22/12576/vp-hands-out-aicte-eci-iste-chhatra-vishwakarma-aicte-sagy-initiative-awards.html https://biospectrumindia.com/news/22/12576/vp-hands-out-aicte-eci-iste-chhatra-vishwakarma-aicte-sagy-initiative-awards.html Wed, 23 Jan 2019 15:35:00 +0530 Vice President of India, Venkaiah Naidu recently addressed the presentation ceremony of AICTE-ECI-ISTE Chhatra Vishwakarma Awards and AICTE- SAGY Initiative awards in New Delhi. While addressing the ceremony he said, “Awards would challenge young students to come up with novel ideas that have great potential to impact life in villages through technological interventions at the grass root level." Highlighting the importance of redeeming agriculture sector which is still the main stay of rural economy, the Vice President said that we have to constantly innovate and reinvent our agricultural practices to make farming much more rewarding, profitable and sustainable. Expressing his firm conviction that development and environmental conservation are not mutually exclusive goals but are complimentary, the Vice President urged young technocrats to consider the environmental cost of their innovations on a priority basis while calculating feasibility. ‘We can no longer afford to neglect our ecological footprint’, he warned.  Expressing his anguish at the dual challenges of malnutrition and hidden hunger on one hand and obesity and lifestyle diseases on the other, that India faces today, he urged young people to maintain a balanced diet and lead a healthy life style and said, “Only a healthy nation can be a wealthy nation.” Calling for balanced development, the Vice President said that our approach to development must have a dual focus, it must be comprehensive and must keep both urban and rural realities in view. “Our urban spaces were becoming increasingly congested and suggested that distress migration could be prevented by providing livelihood, connectivity, health services, infrastructure and avenues for recreation in rural areas”, he added. The Vice President said that 3 ‘D’s - Demography, Demand and Democracy are making the India of today outshine other countries in the world and added that he had full faith in the vision and capabilities of India’s youth who make up 65% of the country’s population. He congratulated the All India Council of Technical Education’s endeavour to catalyse rural development in association with the Engineering Council of India (ECI) and the Indian Society for Technical Education (ISTE).      ]]> https://biospectrumindia.com/news/22/12552/fda-approves-first-generic-version-of-sabril-to-treat-seizures.html https://biospectrumindia.com/news/22/12552/fda-approves-first-generic-version-of-sabril-to-treat-seizures.html Mon, 21 Jan 2019 17:15:00 +0530 The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments. "Prioritizing the approval of generic drugs to compete with medicines that face little or no competition is a key part of our efforts to support access and reduce drug costs to patients. The availability of high-quality generic alternatives of critically important medicines, once the period of patent protection or exclusivity has ended on the brand drug, helps advance access and saves consumers billions of dollars each year,” said FDA Commissioner Scott Gottlieb, M.D. “We know there has been past interest in developing a generic alternative to this product. Earlier this year, we also highlighted this drug, along with many others, on a list of off-patent, off-exclusivity branded drugs without approved generics, to clarify that there were no patents or exclusivities that should impede its approval. Today’s action demonstrates that there is an open pathway to approving products like this one. We’re especially focused on new policies aimed at making the generic review process more predictable, efficient and lower cost so we can entice more generic firms to enter this space, and help facilitate more generic drug launches after generic approvals. We know it’s not enough just to approve a record number of generic medicines. We also want to see firms launch these products so that patients can benefit from their availability, and we intend to take steps to advance these goals." Complex partial seizures, a common type of seizures, start in a specific area of the brain and can affect consciousness. Typically, complex partial seizures last between 30 and 90 seconds, and are often followed by a period of disorientation, confusion and/or fatigue. The FDA requires appropriate data and information to demonstrate that generic drugs meet the agency’s rigorous approval standards to ensure quality drug products that are as safe and effective as their brand name counterparts. As with brand-name drugs, the FDA also inspects manufacturing and packaging facilities for generic drugs to ensure that they are capable of consistently producing quality products. Labeling for vigabatrin tablets includes a boxed warning for permanent vision loss. Teva’s generic vigabatrin tablets is part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) program with other drug products containing vigabatrin to ensure the safe use of the product. Brand and generic drug makers are required to develop a single shared-system REMS program (unless FDA waives the single shared system requirement) when a generic drug seeks approval and the brand drug has a REMS associated with it.   ]]> https://biospectrumindia.com/news/22/12548/mtai-seeks-streamlining-of-taxes-duties-to-make-medical-devices-affordable.html https://biospectrumindia.com/news/22/12548/mtai-seeks-streamlining-of-taxes-duties-to-make-medical-devices-affordable.html Mon, 21 Jan 2019 14:35:00 +0530 Medical Technology Association of India (MTaI), has said that the government should streamline tax and duty structure in Union Budget 2019-20 to ensure people get long-term access to quality medical devices. Since 2017, the government has taken various measures to curb the price of medical devices. Price ceiling has been imposed on devices like stents and knee implants, while only a limited 10% annual price increase is allowed for other ‘non-scheduled’ products. This is so, irrespective of cost challenges the manufacturers encounter during the year. In Addition to this, the dual effect of weakening of currency and inflationary trends has created an extra-ordinary situation and the medical device companies are finding it difficult to sustain the supply of medical devices in the present situation. Meanwhile, the high custom duties levied on medical devices have created a cascading incremental effect on the landed cost of medical devices and is a major concern for the medical device industry. Approximately 70% of medical devices are imported into India to meet the rising demand for quality healthcare. Pavan Choudary, Chairman & Director General, MTaI said, “We are in a constant dialogue with the government on price control which we feel hampers technology innovation in the MedTech industry, and will continue providing suggestions for a sustainable solution. There are several other concerns that threaten affordability and patient accessibility to quality and the latest technology in medical devices.” The issues which need to be addressed in the budget this year are stated in detail below: High Custom Duties: The high custom duties have adversely impacted the costs of products in India which contradicts the government’s efforts to provide low cost healthcare available to masses through the Ayushman Bharat program (PMJAY). We seek reduction of custom duties to 2.5% including all surcharges. Additionally, since the custom duty regime on most medical devices in neighbouring countries of Nepal, Bangladesh, Sri-Lanka, and Bhutan is lower than in India, the duty differential could lead to smuggling of low-bulk-high-value devices. The result will not only be loss of revenue for the government but also the patient will be beset with products which are not backed by adequate legal and service guarantees. Another point to note is that China, which has near self-sufficiency in segments like consumables, had reduced custom duties from 4% to 3.3% to avoid the problem of smuggling and to inject competition in the sector.   Customs Duty & GST on Spare Parts: Custom duty on spare parts of the medical equipment are currently charged at a higher rate than the equipment itself. For example Heart Lung Machine attracts basic custom duty of 7.5% & GST of 12% whereas its spare parts like Roller Pump attracts basic customs duty of 10% and GST of 18%. Similarly, GST on Contact Lenses is 12%, whereas the Contact Lens Solution which is the essential part of using Contact Lenses attract 18% GST. We recommend that the same customs duty and GST should be charged on spare parts and medical equipment. Tax Holiday for R&D: Tax holiday should be provided to medical device R&D centres under the Transfer Pricing Act to boost investment in setting up in-house R&D capabilities. We also seek tax incentives for the industry for developing global patents from India and tax deduction on income made by individuals or a company for rewards earned on patent development or patent licensing. Minimum Alternate Tax: We urge the government to reduce Minimum Alternative Tax (MAT) rate to 15% from the present effective rate of 21.34% (including surcharge and education Cess). The high rate of MAT has cast substantial burden on companies which are already affected by various external factors. Conceptually, MAT is a minimum and an alternate tax and hence it should not be at a rate which is more than 50% of the basic corporate tax rate. GST on Trials and Samples: GST should not be charged on trials and samples as doctors need samples/free trials/demos in order to satisfy themselves on efficacy of product in best interest of patients. Cost of trials are already built into cost structures and is a business expense. GST on Healthcare Services: Healthcare services are currently exempt from GST. As a result, hospitals are not able to claim GST input. This results in higher cost of treatment for the patient.  Once zero rated, Hospitals will be able to avail GST credit on inputs, leading to lower healthcare services cost. Expenditure on CSR: Expenditure on CSR is being disallowed in tax computation. CSR Expenditure has been mandated under law and therefore should be claimable as tax deductible expenditure. Tax Incentives on Exports: Currently, there are no tax benefits on export income. Export being a growth engine for the economy it is important that efforts should be made to make it competitive in the international market. India’s export performance in last 2-3 years has been on a decline which impacts the balance of trade. Introduction of export incentives related to direct tax exemption for the export profits would attract more investments to sectors like medical devices.   ]]> https://biospectrumindia.com/news/22/12540/shripad-naik-to-inaugurate-2nd-world-integrated-medicine-forum-2019-in-goa-.html https://biospectrumindia.com/news/22/12540/shripad-naik-to-inaugurate-2nd-world-integrated-medicine-forum-2019-in-goa-.html Mon, 21 Jan 2019 10:10:00 +0530 Shripad Yesso Naik, Union Minister of State (Independent Charge) for AYUSH will inaugurate the 2nd World Integrated Medicine Forum 2019 on the ‘Regulation of Homeopathic Medical Products; Advancing global collaboration’ being organized from 23-25 January, 2019 in Goa.  The organizers of the forum are the Central Council for Research in Homeopathy, under the Ministry of AYUSH.  International drug regulators dealing with homeopathic/traditional medicines from various countries like France, Switzerland, Germany, Belgium, Spain, Russia, Brazil, Cuba, South Africa, United Arab Emirates, Thailand, Malaysia, Oman, Indonesia, Bangladesh, Nepal, etc. are expected to participate. The themes of the forum are: Regulatory collaborations, Converging on minimum regulatory & legal standards, Advancing safety and quality standards, Regulatory trend towards standardization and minimizing complexity, Recognizing homeopathy as distinct holistic medical system and Veterinary homeopathy. The regulation of homeopathic medicinal products is highly variable worldwide, ranging at a national level from highly advanced to none whatsoever. The potential benefits of regulatory collaboration and harmonization for patients and global markets are significant, but supranational collaboration is advancing only slowly due to highly disparate national situations. There is a tension between different regulatory needs: on the one hand there is a need for standardization, harmonization and reducing complexity; on the other hand there is need for a pluralistic regulatory system, which respects the specific characteristics of homeopathy as a holistic, patient-centred medical system. The forum will explore and illustrate the potential benefits and pitfalls of bi-lateral/multilateral collaboration and advance global cooperation on a synergistic basis. The increasing demand for homeopathic products by patients and health care providers worldwide needs to be underpinned by appropriate regulatory frameworks which respect the national context as well as benefit from experiences and collaboration at an international level. Key stakeholders and opinion leaders who will be attending the event are: Regulators from all over the world, Homeopathic pharmaceutical companies worldwide, Pharmacopoeia Committee delegates from various countries, scientific experts with relevant expertise and Presidents of major homeopathic doctor organizations   ]]> https://biospectrumindia.com/news/22/12513/ayush-ministry-approves-ccras-policy-for-commercialising-newly-developed-ayurvedic-drugs.html https://biospectrumindia.com/news/22/12513/ayush-ministry-approves-ccras-policy-for-commercialising-newly-developed-ayurvedic-drugs.html Wed, 16 Jan 2019 17:35:00 +0530 In order to streamline and expedite the commercialization of ayurvedic drugs, Ayush ministry has approved CCRAS policy. Now, newly developed ayurvedic medications would reach pharmacy shelves at a quicker pace. The guidelines prepared by the Central Council of Research in Ayurvedic Sciences (CCRAS) focus on transferring technology to industry, calculating royalty and resolving intellectual property rights issues. The new provisions for commercialising products, technologies and processes have been approved by Union minister of state for Ayush Shripad Naik. CCRAS policy has provisions for Benchmarks for undertaking research/research consultation for already commercialized/marketed Ayurveda Products in the existing CCRAS Research Policy. Further, the Drugs, Technologies and process etc. developed by the Council are being commercialised through National Research Development Corporation (NRDC), New Delhi under Ministry of Science & Technology as per the provisions of Memorandum of Understanding entered with NRDC. In view of expansion of the scope of R&D and its commercialisation as per the provisions of CCRAS Research Policy, different categories of the products / technologies and processes need to be transferred for further commercialisation. In the last two years, the council has successfully commercialised products such as Ayush-82 for type –II diabetes and Ayush SG for rheumatoid arthritis. These formulations are already available in the market and are cost effective compared to other forms of therapy. ]]> https://biospectrumindia.com/news/22/12504/ficci-welcomes-govts-move-to-accord-industry-status-to-hospitals.html https://biospectrumindia.com/news/22/12504/ficci-welcomes-govts-move-to-accord-industry-status-to-hospitals.html Wed, 16 Jan 2019 12:00:00 +0530 The Federation of Indian Chambers of Commerce and Industry (FICCI) has welcomed the Government's announcement of according 'industry status' to private hospitals, along with support for land acquisition, clearances and funding, to boost expansion of healthcare infrastructure in tier 2 and 3 cities. The announcement follows the launch of Ayushman Bharat PMJAY in September 2018, which aims to provide 10.74 crore poor and vulnerable families (nearly 50 crore beneficiaries) with an annual cover of Rs. 5 lakhs per family for secondary and tertiary care hospitalisation. Welcoming the move by the government and highlighting the need for more healthcare delivery organisations to ensure access under PMJAY, Sangita Reddy- Senior VP, FICCI and Joint MD, Apollo Hospitals Enterprise Ltd said, "In India, skewed distribution of hospital beds, with their heavy concentration in the metros has long been a challenge in reaching the last mile with quality healthcare provision. This opportune step by the government strongly reinforces private healthcare providers' commitment towards improving access to quality care." She added that "FICCI's Health Services Committee has been advocating for more than a decade for long term financing options and viability gap funding for healthcare sector and it is heartening to see it shaping into reality". In the last decade, 70% of the new bed capacity additions were in the private sector, which also caters to 70% of in-patient and 60% of out-patient healthcare services in the country. Appreciating the intent of the government to build an enabling environment for successful implementation of PMJAY, (Hony) Brig Dr Arvind Lal- Chair, FICCI Health Services Committee and CMD, Dr Lal PathLabs Ltd said, "The key to engage more private healthcare organisations will be a viable model for their sustainability. The new hospitals which will be mandated to empanel under PMJAY should be allowed to charge other patients who can afford to pay as per market rates, as the current PMJAY package rates may not be sustainable to set up and run operations in such locations". Speaking from his experience in setting up and operating hospitals in non-metro cities, Dr Alok Roy- Co-chair, FICCI Health Services Committee and Chairman, Medica Group of Hospitals said, "Through incentives like viability gap funding of up to 40% of the total project cost and gap funding of up to 50% of tax on capital cost, the government is providing opportunity for emergence of innovative hospital formats, such as no-frill high quality hospitals." Apart from aiding expansion of bed capacity, the new hospitals will open avenues for employment in tier 2 and 3 cities, in the healthcare sector. ]]> https://biospectrumindia.com/news/22/12499/dbt-icar-sign-mou-to-promote-innovations-in-agri-bio-.html https://biospectrumindia.com/news/22/12499/dbt-icar-sign-mou-to-promote-innovations-in-agri-bio-.html Wed, 16 Jan 2019 10:10:00 +0530 The Department of Biotechnology (DBT) has undertaken several activities and programs to promote Biotechnology Research & Development in the areas of Agriculture Biotechnology. The Indian Council of Agricultural Research (ICAR) has been coordinating, guiding and managing research and education in Agriculture including horticulture, fisheries and animal sciences in the entire country. In order to leverage the efforts, the DBT and ICAR has entered into Memorandum of Understanding (MoU) for much-needed emphasis on multi-disciplinary R&D activities and nurturing innovations in Agricultural Biotechnology Research and Education. Highlighting the importance of the MoU, Renu Swarup, Secretary DBT said, “Five to ten focused programmes both short, medium and long term will be developed and implemented. Major facilities and technology platforms created by both the agencies will be accessible to the National systems and a joint working group will be constituted to take the partnership forward.” The collaborations also encompass to promote agri-innovations and start-ups, through the well-established BIRAC mechanism. This flagship synergistic approach would be taken-up in mission mode through networking with the elite institutions in the Country. The MoU between ICAR and DBT is for mutual collaboration to explore the possibility of cooperation, convergence and synergy to promote and accelerate the progress of research and training in various disciplines of agricultural biotechnology between ICAR and DBT. The MoU will be implemented with the aim to collaborate with one another in mutually agreed-upon research programmes in the areas of agricultural biotechnology, funding of projects, policy issues, regulatory aspects, and other specified areas of National interest. The specific objectives are to plan and implement jointly the mutually agreed major National programmes through joint funding and sharing of resources in the priorities areas of agricultural biotechnology; to form common think tank of experts from ICAR and DBT and others to formulate policies; to establish National platform/centres for services related to genomics, genotyping, data banking, agriculture bioinformatics, GM food detection, validation of technologies such as vaccines, diagnostics of veterinary/ fisheries use, molecular markers in crop and animal breeding; to formulate and introduce courses/training programmes in the area of IPR, biosafety, biodiversity conservation and germ plasm exchange, genomic selection and breeding for faculty and students through appropriate mechanisms and; research prioritization with other ministries and foreign collation like Indo-UK SIC, BRICS, African countries and ‘Look East’ programme in relation to agricultural biotechnology.   ]]> https://biospectrumindia.com/news/22/12472/cabinet-approves-setting-up-of-3-new-aiims.html https://biospectrumindia.com/news/22/12472/cabinet-approves-setting-up-of-3-new-aiims.html Fri, 11 Jan 2019 10:55:00 +0530 The Union Cabinet, chaired by the Prime Minister Narendra Modi, has given its approval for establishment of three new AIIMS at (i) Vijaynagar, Samba, Jammu at a cost of Rs.1661 crore (ii) Awantipura, Pulwama, Kashmir, at a cost of Rs.1828 crore and (iii) Rajkot, Gujarat at a cost of Rs.1195 crore. These AIIMS will be set up under Pradhan Mantri Swasthya Suraksha Yojana (PMSSY). Establishment of new AIIMS involves creation of Hospital, Teaching Block for medical & nursing courses, residential complex and allied facilities/services, broadly on the pattern of AIIMS, New Delhi and other six new AIIMS taken up under Phase-I of PMSSY. The objective is to establish the new AIIMS as Institutions of National Importance for providing quality tertiary healthcare, medical education, nursing education and research in the Region. Setting up new AIIMS in Jammu & Kashmir and in Gujarat will lead to employment generation for nearly 3000 people in various faculty & non faculty posts in each of the AIIMS. ]]> https://biospectrumindia.com/news/22/12446/lok-sabha-passes-the-dna-technology-use-and-application-regulation-bill-2019.html https://biospectrumindia.com/news/22/12446/lok-sabha-passes-the-dna-technology-use-and-application-regulation-bill-2019.html Tue, 08 Jan 2019 18:15:00 +0530 The Lok Sabha has passed “The DNA Technology (Use and Application) Regulation Bill - 2019”. The Bill has been formulated recognizing the need for regulation of the use and application of Deoxyribonucleic Acid (DNA) technology, for establishing identity of missing persons, victims, offenders, under trials and unknown deceased persons. The purpose of this Bill is to expand the application of DNA-based forensic technologies to support and strengthen the justice delivery system of the country. The utility of DNA based technologies for solving crimes, and to identify missing persons, is well recognized across the world. By providing for the mandatory accreditation and regulation of DNA laboratories, the Bill seeks to ensure that with the proposed expanded use of this technology in this country, there is also the assurance that the DNA test results are reliable, and furthermore that the data remain protected from misuse or abuse in terms of the privacy rights of our citizens. The key components of this Bill include: establishment of a DNA Regulatory Board; accreditation of DNA laboratories undertaking DNA testing, analysing, etc.; establishment of the National and Regional DNA Data Banks, as envisaged in the Bill, will assist in forensic investigations. This will aid in scientific up-gradation and streamlining of the DNA testing activities in the country with appropriate inputs from the DNA Regulatory Board which would be set up for the purpose. The Bill also aims to add value in empowering the criminal justice delivery system by enabling the application of DNA evidence, which is considered the gold standard in crime investigations.     ]]> https://biospectrumindia.com/news/22/12428/inclusion-of-medical-device-industry-in-dtab-subcommittee-is-a-step-in-right-direction-mtai.html https://biospectrumindia.com/news/22/12428/inclusion-of-medical-device-industry-in-dtab-subcommittee-is-a-step-in-right-direction-mtai.html Mon, 07 Jan 2019 15:30:00 +0530 Medical Technology Association of India (MTaI), which represents research-based medical technology companies having a large footprint in manufacturing and training in India believes that the formulation of DTAB sub-committee to examine proposal for inclusion of compensation in the policy framework on medical devices is a step in the right direction. Pavan Choudary, Chairman and Director General, MTaI said, “The inclusion of Medical Device industry in the subcommittee is a positive step towards having a well-rounded decision on the proposal for inclusion of compensation in the Medical Device Rules. We will work with the expert panel to form a suitable framework on compensation, keeping in mind the interest of the stakeholders.” Drugs Technical Advisory Board (DTAB) which is a panel under the Union Health Ministry has decided to set up a sub-committee to assess the issues related to proposal for amendment of MDR 2017 to include provisions for compensation in case of injury or death due to malfunctioning of medical devices or if the devices are found unsafe or non-compliant with the conditions of licence. The committee is headed by Dr. B.D. Athani, Principal Consultant in Directorate General of Health Services (DGHS) and has representatives of the government, AIIMS and Safdarjung Hospitals, Medical devices industry, and consumers. ]]> https://biospectrumindia.com/news/22/12400/cabinet-approves-restructuring-of-national-health-agency-as-national-health-authority-.html https://biospectrumindia.com/news/22/12400/cabinet-approves-restructuring-of-national-health-agency-as-national-health-authority-.html Thu, 03 Jan 2019 09:15:00 +0530 The Union Cabinet chaired by Prime Minister Narendra Modi has approved the restructuring of existing National Health Agency as "National Health Authority" for better implementation of Pradhan Mantri - Jan Arogya Yojana (PM-JAY). With this approval, the existing society "National Health Agency" has been dissolved and will be replaced by National Health Authority as an attached office to Ministry of Health & Family Welfare. The existing multi-tier decision making structure has been replaced with the Governing Board chaired by the Minister of Health & Family Welfare, Government of India which will enable the decision making at a faster pace, required for smooth implementation of the scheme. The composition of the Governing Board is broad based with due representations from the Government, domain experts, etc. Besides, the States shall also be represented in the Governing Board on rotational basis. No new funds have been approved. Existing budget that was approved earlier by the Cabinet for The National Health Agency, including costs related to IT, human resources, infrastructure, operational costs etc. would be utilized by the proposed National Health Authority. It is envisaged that the National Health Authority shall have full accountability, authority and mandate to implement PM-JAY through an efficient, effective and transparent decision-making process.   ]]> https://biospectrumindia.com/news/22/12399/cabinet-approves-continuation-of-five-umbrella-scheme-.html https://biospectrumindia.com/news/22/12399/cabinet-approves-continuation-of-five-umbrella-scheme-.html Wed, 02 Jan 2019 17:55:00 +0530 The Cabinet Committee on Economic Affairs, chaired by the Prime Minister Narendra Modi, has given its approval for continuation of five schemes under the "Umbrella Scheme for Family Welfare and Other Health Interventions" during the Fourteenth Finance Commission period 2017-18 to 2019-20. An overall outlay of Rs. 2381.84 crore for the scheme will be spent during the Fourteenth Finance Commission period 2017-18 to 2019-20 and would be funded 100% by Central Government Budgetary support. Components of, Social Marketing of Contraceptives, Free Supply of Contraceptives are specifically targeted towards low income group people. However, the overall scheme is not restricted to any particular group or category and has a mandate to cover the population throughout India. The five schemes listed in the proposal are crucial to attaining the goals and objectives laid out in National Health Policy (NHP) 2017, and international commitments in the form of Sustainable Development Goals (SDGs). The SNA scheme has a very ambitious target of improving health seeking behaviour of the population through increased awareness and enhanced uptake of health services. The other components as HSHR would assist in keeping a tab on the progress of entire set of health programmes/schemes run by Government of India, assisting in timely course corrections. The free and social marketing of contraceptives will enable better child and mother health, besides population stabilisation. The target is to support the key goals of the National Health Policy 2017 and the Sustainable Development Goals (SDGs) to which India is a signatory. The attempt through Media / IEC outreach is to move from care for sickness to the concept of wellness by using 360 degree approach in conventional and social media. The target of the free distribution and social marketing of contraceptives is to improve the Modern Contraceptive Prevalence Rate (mCPR), help Family Planning and reach population stabilization. The target for NFHS is to provide reliable data on all health indicators. All the five schemes are Central Sector Schemes with 100% funding from Central Government.  These are as follows: Swastha Nagrik Abhiyan(SNA):For dissemination of information on health issues to create awareness among citizens of India of ail age/sex/locations and appropriately influence their health seeking behavior to encourage healthy lifestyles and empower the citizens. SNA has been approved, with an estimated outlay of Rs. 1030.15 crore for three years. Free Supply of Contraceptives: For providing free supply of contraceptives including   condoms,  Oral    Contraceptive    Pills,    Pregnancy    Test    Kits,    other contraceptives, etc. to States with a view to improve Maternal and Child Health and achieving population stabilization. MIS Scheme now proposed as Health Surveys and Health Research (HSHR):For sourcing of data on population, health and nutrition for India and its States including through periodically conducted National Family Health Survey, which is one of the largest surveys of its kind worldwide. The NFHS provides valuable data for policy and programmes right up to the district level. Social Marketing of Contraceptives:For branding, attractively packaging, marketing arid selling of products and services related to Family Planning for low-income groups at affordable prices. Population Research Centres (PRCs):For third party evaluation of the scheme on PRCs and specially of those centres which are being considered for continuation will be carried out.     ]]> https://biospectrumindia.com/news/22/12395/nabcb-gets-recognition-for-occupational-health-and-safety-management-systems.html https://biospectrumindia.com/news/22/12395/nabcb-gets-recognition-for-occupational-health-and-safety-management-systems.html Wed, 02 Jan 2019 12:55:00 +0530 The National Accreditation Board for Certification Bodies (NABCB), India’s national accreditation body, has secured equivalence for its accreditation programme for Occupational Health and Safety Management Systems (OHSMS) Certification Bodies in Asia- Pacific region. It has signed the Multilateral Recognition Arrangement (MLA) of the Pacific Accreditation Cooperation (PAC) to this effect on 19 Dec 2018. The NABCB accreditation programme is based on international standards, ISO/IEC 17021-1 and ISO 45001, applicable for OHSMS. The recognition by PAC is based on demonstration by NABCB that it complies with international standard, ISO/IEC 17011, applicable to it and has competence in OHSMS to accredit certification bodies in this sector. NABCB is the third accreditation body in the Asia Pacific Region to become internationally equivalent in the region, the other two being the accreditation bodies of Hong Kong and Mexico. The MLA with PAC would facilitate signing MLA with International Accreditation Forum (IAF) to secure full international equivalence. IAF signatory member status signifies that the accreditation of certification bodies by NABCB for Occupational Health and Safety Management Systems will be accepted as internationally equivalent. NABCB, a constituent Board of the Quality Council of India, is responsible for accreditation of certification/inspection bodies as per applicable international standards under an international system of equivalence. NABCB has already secured international equivalence for its accreditation programmes for ISO 9001 certification bodies in 2002 and ISO 14001 certification bodies in 2007, Product certification bodies based on ISO 17065 in 2013, Inspection Bodies based on ISO 17020 also in 2013, Global Gap in 2014, ISO 22000 certification bodies and ISMS certification bodies as per ISO 27001 in 2015 and Energy Management System as per ISO 50001 in 2018. Accreditation reduces risk for business and its customers by assuring that accredited Certification Bodies (CBs) are competent to carry out the work they undertake within their scope of accreditation. Accreditation Bodies (ABs) that are members of PAC and the CBs they accredit are required to comply with appropriate international standards and the applicable PAC application documents for the consistent application of those standards. ABs that is signatories to the PAC Multilateral Recognition Arrangement (MLA) are evaluated regularly by an appointed team of peers to provide confidence in the operation of their accreditation programs. Accreditation has become an essential tool for getting acceptance of inspection, testing and certification done in India internationally and it is referenced in many bilateral Free Trade Agreements like the India – Singapore Comprehensive Economic Cooperation Agreement in which NABCB accreditation is a requirement for certification of electrical/electronic and telecom products. Thus, accreditation eliminates technical barriers to trade and facilitates export of Indian products in world market. NABCB has currently accredited 6 certification bodies for Occupational Health and Safety Management Systems. Now any industry carrying ISO 45001 certificate with NABCB logo will be recognized in the Asia Pacific region. The immediate beneficiary of this equivalence is the Indian Industry which is exporting products to various countries specially in the Asia Pacific region. It can also be used by regulators for establishing confidence in certified units as Goa Govt has done by accepting OHSMS certification under NABCB accreditation in lieu of annual audits under Factories’ Act. With the above, NABCB hopes to facilitate export of Indian goods into the world market by attesting that these are certified as per international standards by competent certifying bodies. ]]> https://biospectrumindia.com/news/22/12373/cabinet-approves-setting-up-of-ncim-bill-2018.html https://biospectrumindia.com/news/22/12373/cabinet-approves-setting-up-of-ncim-bill-2018.html Mon, 31 Dec 2018 10:40:00 +0530 The Cabinet has approved the draft National Commission for Indian Systems of Medicine (NCIM) Bill, 2018, which seeks to replace the existing regulator Central Council for Indian Medicine (CCIM) with a new body to ensure transparency. The draft bill provides for the constitution of a National Commission with four autonomous boards entrusted with conducting overall education of Ayurveda, under Board of Ayurveda and Unani, Siddha &Sowarigpa under Board of Unaini, Siddha and Sowarigpa. There are two common Boards namely, Board of assessment and rating to assess and grant permission to educational institutions of Indian systems of Medicine and Board of ethics and registration of practitioners of Indian systems of medicine to maintain National Register and ethical issues relating to practice under the National Commission for Indian Medicine. It also proposes a common entrance exam and an exit exam, which all graduates will have to clear to get practicing licenses. Further, a teacher's eligibility test has been proposed in the Bill to assess the standard of teachers before appointment and promotions. The draft bill is aimed at bringing reforms in the medical education of Indian medicine sector in lines with the National Medical Commission proposed for setting up for Allopathy system of medicine. ]]> https://biospectrumindia.com/news/22/12372/cabinet-approves-setting-up-of-the-nch-bill-2018.html https://biospectrumindia.com/news/22/12372/cabinet-approves-setting-up-of-the-nch-bill-2018.html Mon, 31 Dec 2018 10:35:00 +0530 The Union Cabinet chaired by Prime Minister, Narendra Modi has approved the draft National Commission for Homoeopathy, Bill, 2018, which seeks to replace the existing regulator Central Council for Homoeopathy (CCH) with a new body to ensure transparency. The draft bill provides for the constitution of a National Commission with three autonomous boards entrusted with conducting overall education of Homoeopathy by Homoeopathy Education Board. The Board of assessment and rating to assess and grant permission to educational institutions of Homoeopathy and Board of ethics and registration of practitioners of Homoeopathy to maintain National Register and ethical issues relating to practice are under the National Commission for Homoeopathy. It also proposes a common entrance exam and an exit exam which all graduates will have to clear to get practicing licenses. Further, a teacher's eligibility test has been proposed to assess the standard of teachers before appointment and promotions. It further aims at bringing reforms in the medical education of Homoeopathy in lines with the National Medical Commission proposed for setting up for Allopathy system of medicine. The CCH had been earlier superseded by Board of Governors through an Ordinance and subsequent amendment of Act. ]]> https://biospectrumindia.com/news/22/12345/niti-aayog-pitches-for-enactment-of-national-medical-commission-bill.html https://biospectrumindia.com/news/22/12345/niti-aayog-pitches-for-enactment-of-national-medical-commission-bill.html Wed, 26 Dec 2018 11:00:00 +0530 Government think-tank NITI Aayog has pitched for the enactment of the National Medical Commission (NMC) Bill, 2017, observing that regulatory bodies the Medical Council of India and the Nursing Council of India have "failed" to ensure adequate availability and quality of health professionals. In its 'Strategy for New India @75' document released on Wednesday, the Aayog has recommended revamping of the regulatory system of nursing education to ensure quality training in nursing schools and also stressed on developing centres of excellence in nursing and enhancing the stature of government nurses. The Aayog said the quality of health professional training and adherence to standards is sub-optimal, including in the private sector. To address the shortage of doctors in the country, the Aayog has suggested creating conditions to facilitate import of doctors, especially those of Indian origin working abroad, and also deploying teachers from universities abroad as visiting professors at AIIMS or NIEs while linking at least 40 per cent of district hospitals with medical colleges. It also suggested developing a framework for the deployment of doctors and specialists from the private sector to government hospitals on a visiting or honorary basis and expanding the system of Diplomate of National Board (DNB) and Diplomas from College of Physicians and Surgeons (CPS). "Workforce shortages and uneven distribution of doctors, nurses, specialists and allied health professionals plague the sector," the Aayog said while observing that urban areas have four times as many doctors and three times as many nurses as compared to rural areas.  Medical and nursing colleges are concentrated in a few states like Andhra Pradesh, Karnataka, Tamil Nadu, Kerala, Gujarat and Maharashtra. Pointing to the severe shortages in the category of allied health professionals (AHPs) including medical lab technicians, optometrists and radiologists, the Aayog has sought the establishment of a Council to ensure standardization of education and putting in place quality control mechanisms for educational institutions, teaching methods and workforce management.  It suggested putting in place an updated curriculum for medical and allied professions that keep pace with the changing dynamics of public health, policy and demographics.  As far as specialists are concerned, the Aayog observed that a large number of posts are vacant all over the country. According to estimates, India needs close to five lakh additional specialists, the report highlighted. There is also an acute shortage of medical faculty. Of the 1,830 faculty posts across six All India Institutes of Medical Sciences (AIIMS), approximately 583 (31 per cent) had been filled up until July 2017, the Aayog pointed out.  According to the report, as of March 2017, there were 10.23 lakh allopathic doctors registered with the MCI or state medical councils. Assuming 80 per cent availability, the Aayog estimated that around 8.18 lakh doctors may actually be available for active service. This gives a doctor-population ratio of 1:1613 against the WHO norm of 1:1000, it said. The current nurse-population ratio is 1:588.  "Due to the suboptimal quality of training offered by several institutions that have mushroomed over the years, limited career prospects and poor working conditions, especially in the private sector, there is a significant shortage of skilled nurses in the country," the Aayog stated. "Private practice by medical faculty in teaching institutions is rampant in several states, compromising on the commitment to teaching and institutional clinical work," it highlighted. Among the constraints, the Aayog mentioned were poor infrastructure in many state and private medical/nursing/dental colleges. It further said that health professionals in the public sector are inadequately compensated and motivation levels are extremely poor. Fair compensation in the private sector, for nurses, is also a challenge.  The Aayog has suggested creating a cadre of primary healthcare practitioners by introducing a three-year competency-based dynamic course for primary, community and family medicine and partner with private hospitals or private medical practitioners to skilled technicians, nursing and para-nursing as well as para-medical staff to deal with the paucity of health professionals, reported PTI.  ]]> https://biospectrumindia.com/news/22/12343/ayush-discussed-globalisation-of-traditional-systems-of-medicine-with-ambassadors.html https://biospectrumindia.com/news/22/12343/ayush-discussed-globalisation-of-traditional-systems-of-medicine-with-ambassadors.html Mon, 24 Dec 2018 15:35:00 +0530 An interactive meeting on ‘Globalisation of Traditional and Alternative Systems of Medicine’ with Ambassadors/High Commissioners of 15 countries was recently organized by ministry of AYUSH. The meeting was coordinated by Central Research Council of Research in Ayurvedic Sciences, New Delhi and was attended by Shripad Naik, Minister of State for AYUSH along with the Ambassadors/High commissioners of Bhutan, UAE, Cuba, Iran, Ghana, Hungary, Trinidad, Oman, Equatorial Guinea, Sri Lanka, Nepal, Switzerland, Mauritius, Bangladesh and The United Kingdom. The focus of the meeting was on role played by Traditional and Complementary Systems of Medicine (TM&CM) in the health care of people, with respect to combating non-communicable diseases and promotion of health alongside the modern medicine across the world with very low cost. Ambassadors, High commissioners and representatives from the participating countries acknowledged the need for diligent integration of TM&CM with modern medicine in combating Non-Communicable diseases to reduce the exorbitant health care expenditure for individuals and to the National exchequer. There was consensus in the meeting that all stake holding countries should come together to work for the globalization of traditional medicine systems for the benefit of humanity. For this purpose, it was acknowledged, induction of Indian Medical systems like Ayurveda, Unani and Siddha in the International Classification of Diseases (ICD) of the WHO would be desirable. The efforts made by the Ministry in creating Ayurveda, Siddha and Unani (ASU) morbidity codes and standardized terminologies in line with W.H.O guidelines for quantification and reporting of health services by AYUSH systems at national level through NAMASTE portal were also discussed. ]]> https://biospectrumindia.com/news/22/12339/indias-largest-convention-for-health-media-organized-by-heal-foundation.html https://biospectrumindia.com/news/22/12339/indias-largest-convention-for-health-media-organized-by-heal-foundation.html Mon, 24 Dec 2018 13:25:00 +0530 HEAL Foundation recently organized a 3 day convention for health media where around 40 leaders of the health care industry interacted with a niche audience of health media. More than 75 health journalists gathered under one roof to upgrade their knowledge about pressing health issues and network with their peers. Addressing the gathered health media, Chief Guest Ashwini Kumar Choubey, Minister of State for Ministry of Health & Family Welfare said, “It’s an irony that even after seven decades of freedom, 62.58% citizens don’t have health insurance. As a result, every year around 4% citizens get stuck in the vicious cycle of poverty due to unbearable health expenses. Government is upgrading 58 medical colleges and establishing super specialty blocks in 73 medical colleges to fight the menace.” “I congratulate HEAL Foundation for taking the initiative of capacity building of health writers - especially vernacular media - from all parts of the country and I am assured that intense discussion on Ayushman Bharat and healthy India will definitely yield fruitful results and benefit government too”, he added. The convention had key panel discussions on topics like ‘Menace of Fake Health News’ and ‘Upholding Trust in Healthcare’, where speakers like  Dr Ashok Seth Padam Bhushan Awardee, Chairman and Cardiologist Fortis Hospital, Dr Shakti Kumar Gupta Medical Superintendent AIIMS and  K G Suresh, Director General of Indian Institute of Mass Communication, presented their viewpoints. Suresh also promised a long-term association with HEAL Foundation for the capacity building of the health writers and editors. Ashi Kathuria, Senior Nutrition Specialist at World Bank shared insights on FSSAI’s Eat Right India Movement which is spreading the message of Food Fortification, Food Safety, Reduced intake of foods high in fats, sugar, and salt,  and 1st 1000 days of life India wide. Sharing his opinion on Upholding Trust in Healthcare, Dr. Seth said, “Doctors always work under a lot of pressure during odd hours, which often results in miscommunication or no communication. For trust building among patients and doctors, it is very important for doctors to have empathy toward patients. A clear and polite communication goes a long way in trust building. Few words from doctors decide the words of patient’s relatives if things go haywire. Patient’s feedback for the same result can be ‘Doctor tried his best’ or ‘doctor was negligent’ depending on doctor’s empathy and communication.” Swadeep Srivastva, Founder HEAL Foundation, and Founding Managing Partner India Virtual Hospital said, “The convention has established itself as a bridge between health journalists and doctors, hospitals, pharma industry, and other industry players. Journalists get the opportunity for capacity building from key industry leaders that give them access to the first-hand information about industry developments. The objective of the 6th convention was to touch-base our health writers and editors with the recent advances in the healthcare industry and increasing roles and responsibilities of health media in the holistic improvement of healthcare.” The event was concluded with the distribution of HEAL Health Honours – recognizing excellence in healthcare.     ]]> https://biospectrumindia.com/news/22/12336/holistic-quality-enhancement-is-the-need-of-the-hour-70th-indian-pharmaceutical-congress-.html https://biospectrumindia.com/news/22/12336/holistic-quality-enhancement-is-the-need-of-the-hour-70th-indian-pharmaceutical-congress-.html Mon, 24 Dec 2018 12:05:00 +0530 With the aim of sharing best practices to aid the domestic industry become a world leader by 2030, the three-day 70thIndian Pharmaceutical Congress was organized at the Amity University Campus, NOIDA recently. It was inaugurated by Venkaiah Naidu, Vice President of India. More than 60 speakers from both India and abroad participated in the power-packed panel discussions on the critical topics like Over-The-Counter drug regulation, risk and safety in the era of multi-drug resistant microbial strains, the challenges people face in accessing quality diagnostic services, the relationship between the pharmacist – as the first point of contact – and the patient and how the menace of fake medicines can be curbed. Atul Nasa, Head of Office/ Controlling Authority, Drugs Control Department, Delhi, said on the occasion, “The coming months will see stricter implementation of quality standards and increased awareness of the risks of online pharmacy. OTC drugs need greater regulation to prevent unmonitored use and abuse”. BR Sikri, Chairman, LOC of 70th IPC said, “No other country in the world is able to supply affordable medicines to the world at affordable prices than India. The interaction between regulating authorities and top CEOs of industry will ensure that there is a more congenial interface between industry and the government to promote smoother access of life-saving medicines to all our people.” Whereas the Indian diagnostics market was a $ 9.6 million industry, just under 20% of Indians have ever given their blood for testing while Tier III & IV towns are deprived of quality diagnostic facilities. However, the government is fully geared to increase healthcare spending from 1.3% of the GDP to 2.5% of the GDP by 2025. Tele-pathology could play a great role in reducing costs of diagnostics in such cases. Increased penetration of health insurance can also play a pivotal role in increasing diagnostic access. Diagnosis was now moving from simple intervention to real-time monitoring and predictive markers. Hence, it offers vast employment opportunities to young and passionate learners. The Panel Discussion on Over-the-Counter drug retail and regulation, threw up crucial points such as the dangers of self-medication and the need to raise awareness of the rules concerning OTC medicine delivery and consumption. Dr. R Chandershekhar, Deputy Drugs Controller (I), CDSCO, stressed on the importance of compliance, safety and risk control standards in the age of e-pharmacy and online pharmacy. India exports pharmaceutical products to over 180 countries around the globe, of which, 30% goes to the US alone. While India’s drug industry is set to grow at 13%, the same sector in the US was growing at just 3%. For the first time, India exported drugs worth $ 17 billion – a huge achievement. In the next 10 years, India’s pharma trade will be worth $ 200 billion which speaks for the efficacy of India-made drugs in the world.   ]]> https://biospectrumindia.com/news/22/12316/mtai-welcomes-governments-decision-to-create-nmdpc.html https://biospectrumindia.com/news/22/12316/mtai-welcomes-governments-decision-to-create-nmdpc.html Thu, 20 Dec 2018 09:55:00 +0530 Medical Technology Association of India supports central government’s decision to set up a National Medical Devices Promotion Council (NMDPC) and  boost the Medical Device Industry in India. Suresh Prabhu, The Union Minister of Commerce and Industry and Civil Aviation at the 4th WHO Global Forum on Medical Devices has pointed out that the National Medical Devices Promotion Council (NMDPC), headed by the Secretary, DIPP, would achieve the much needed convergence as medical devices were previously being covered under various Ministries and departments. This will facilitate formulating better regulatory system in the medical devices sector. Pavan Choudary, Chairman, Medical Technology Association of India (MTaI) said, “Within the overall health ecosystem, medical devices has remained a sector where focused attention is much required. Medical devices are different from other healthcare industries as they develop and grow based on a dynamic innovation and manufacturing ecosystem. Such a system is often born with the help of global legacy technology companies and also allows indigenous entrepreneurs and physicians to create and bring to market local medical technology. We welcome the government’s decision to create a National Medical Devices Promotion Council (NMDPC) to boost the Medical Device Industry and MTaI will help in strengthening this ecosystem.” The Medical Devices Industry (MDI) plays a critical role in the healthcare ecosystem. The manufacturing and trade in MDI is growing steadily in India. Currently with sufficient manufacturing capacity for low cost low risk devices such as surgical gloves; blood bags; extension lines, stop cocks, some IV access products and syringes, India is yet to see extensive growth spikes in high tech medical devices. To ensure patient safety, the industry is investing and focusing on constant technological innovation and upgradation. While the medical devices industry has been growing in double digits it is predominantly import-driven for medical devices with imports accounting for over 70% of the domestic market and around 80% for critical-care devices. The setting up of NMDPC will address the issue of expansion of domestic manufacturing for critical-care devices. The NMDPC order mentions about the robust Preferential Market Access (PMA) policy discouraging unfair trade-practices in imports. “Robust tracking mechanisms from the government to streamline all trade practices have always been welcomed by all MTAI member companies. Our member companies strictly abide by stringent Drugs & Cosmetics Act and Tax (transfer pricing) laws,” added Pavan Choudary. MTAI is looking forward to industry consultation as mentioned in the NMDPC order to set up a robust and dynamic preferential market access policy post industry feedback, trade interventions, emulating global best practices consulting multinational legacy companies.  “There is a requirement to bring in regulations which would incentivize global companies to invest in Indian companies through equity or sweat equity. This will not only attract more global companies to invest in India but also as a result lead to increase in FDI.” said Pavan Choudary. "The last instance being when the current government brought FDI in medical technology on the automatic route on our recommendation and the FDI inflow sky rocketed from $63 million annually to $440 million annually in a span of less than two years”, he added. Global companies support the Make-in-India program and expect a fair opportunity to contribute to the Indian patients with their global products and have proved their worth time and again.   ]]> https://biospectrumindia.com/news/22/12286/cabinet-approves-establishment-of-two-new-aiims-at-tn-telangana.html https://biospectrumindia.com/news/22/12286/cabinet-approves-establishment-of-two-new-aiims-at-tn-telangana.html Tue, 18 Dec 2018 09:00:00 +0530 The Union Cabinet has approved establishment of two new All India Institute of Medical Sciences (AIIMS) at Madurai, Tamil Nadu at a cost of Rs 1,264 crore and Bibinagar, Telangana at a cost of Rs 1,028 crore.  The AIIMS will be set up under Pradhan MantriSwasthya Suraksha Yojana (PMSSY). Setting up of new AIIMS would not only transform health education and training but also address the shortfall of health care professionals in the region. The establishment of new AIIMS will serve the dual purpose of providing super-specialty health care to the population while also help create a large pool of doctors and other health workers in this region that can be available for primary and secondary level institutions / facilities being created under National Health Mission (NHM). Construction of new AIIMS is fully funded by the Central Government. The proposed institution shall have a hospital with capacity of 750 beds which will include Emergency / Trauma Beds, AYUSH Beds, Private Beds and ICU Specialty and Super Specialty beds. ]]> https://biospectrumindia.com/news/22/12255/pm-inaugurates-the-partners-forum-2018-for-health-well-being-.html https://biospectrumindia.com/news/22/12255/pm-inaugurates-the-partners-forum-2018-for-health-well-being-.html Thu, 13 Dec 2018 10:35:00 +0530 “It is only partnerships that will get us to our goals. Partnerships between citizens, Partnerships between communities, Partnerships between countries. The Sustainable Development agenda is a reflection of this.” This was stated by Prime Minister Narendra Modi as he inaugurated the Partners’ Forum, 2018, in New Delhi recently. The Prime Minister also released the coffee table book ‘Proven Paths’,  a compendium of 36 best practices in maternal, child and adolescent health, at the inaugural ceremony. J P Nadda, Union Minister of Health and Family Welfare, Deputy Prime Minister of Nepal UpendraYadav, Gabriela Cuevas Barron, President Inter Parliamentary Union, Kim Simplis Barrow, First Lady of Belize, Ashwini Kumar Choubey and Anupriya Patel, Ministers of State for Health & Family Welfare, Preeti Sudan, Secretary (Health & Family Welfare) and Acting Board Chair, TikhalaItaye, Chairperson, She Decides Global Movementalong with 23 Ministers from 21 countries, representatives from various organizations and participants from 85 countries across the globe were also present at the function. The Prime Minister said that the Partnership for Maternal, New-born, and Child Health, is a unique and effective platform. “We are not only making a case for better health. We are also making an argument for faster growth,” he added. He further said that India was one of the first countries to advocate focused attention on adolescence and implement an extensive health promotion and prevention programme for adolescents. Our effort ensured that they get their due recognition in the Global Strategy for Women’s, Children’s and Adolescents’ Health adopted in 2015, he mentioned. Appreciating the Immunization Programme of the country, Prime Minister said that the programme is close to his heart and he is pleased that it’s being featured as a success story in this forum. “Under Mission Indradhanush, we reached 32.8 million children and 8.4 million pregnant women over the last three years. We have also increased the number of vaccines under the universal immunization programme from 7 to 12. Our vaccines now cover life threatening diseases like- Pneumonia and Diarrhoea,” he elaborated. The Prime Minister stated that the government has launched the PradhanMantriSurakshitMatritvaAbhiyan to provide best possible care to mothers during pregnancy. “We called upon the private sector doctors to pledge one day of service per month to this campaign. Under this campaign, 16 million Ante-Natal care check-ups have been performed,” he added.The Prime Minister further stated that the country has 25 million new-borns. “Our robust facility based new-born care system, which provides care to more than 1 million new-born babies through 794 Special New-born Care Units, has served as a successful model. As a result of our interventions, 840 additional lives of children under five are being saved each day in India as compared to four years back,” he said. Speaking at the function, J P Nadda, Union Minister of Health and Family Welfare said that under the dynamic leadership of the Hon’ble Prime Minister our efforts are bearing fruits. “We have witnessed an accelerated pace of reduction in maternal and child mortality that is much faster than the global average rate of decline and are poised to attain the related SDG targets much before the target deadline,” he stated Reiterating the commitment of the Government, Nadda said that the Government is coming closer to realizing the dream of Universal Health Coverage. “The Ayushman Bharat Yojana, which epitomises political commitment, vision and guidance from the Hon’ble Prime Minister is already being hailed globally as a paradigm shift in healthcare delivery,” he added. The Union Health Minister said that Ayushman Bharat is a holistic scheme that covers all dimensions of health care namely - prevention, health promotion and primary care through 150 thousand health and wellness centres; as well as in patient care through PMJAY a public funded assurance scheme that provides care of uptoRs. 500 thousand annually to 550 million people, constituting about 40% of the nation’s population. “We are also implementing other country-wide programmes like Pradhan Mantri Surakshit Matritva Abhiyan, Mission Indradhanush and Intensified Mission Indradhanush (IMI) for immunization”, Nadda mentioned. Nadda further said that the Hon’ble Prime Minister has envisioned the concept of ‘Aspirational Districts’ wherein 117 lowest performing districts were identified to be taken up for holistic development.  “I am very happy to inform that Health and Nutrition, WASH (Water, Sanitation & Hygiene), Education, are among the sectors that have been given the highest attention for improvement, through a collaborative and multi-sectoral approach. India has also steered the setting up of National Nutrition Mission with an aim of doubling the pace of improving the nutritional status of mothers, children and adolescents, through concerted actions between various departments and stakeholders, he added. J P Nadda also inauguratedthe “Marketplace” at the Forum which is showcasing some of India’s best practices and innovations in reproductive maternal, newborn, child and adolescent health (RMNCH+A); health system strengthening; and communicable and non-communicable diseases. Over 24 best practices/innovations are being showcased under four theme-based pavilions -Ayushman Bharat Hub, Health System Strengthening Hub, Nutrition Hub and Adolescent and Youth Hub. The opening ceremony witnessed and enthralling curtain raiser using projection mapping to display larger than life pre-recorded graphics of Indian women welcoming delegates and a lively animation film of the Partners Forum logo, video with voices of women from across the globe and collage of photographs of women, children and adolescents from various continents of the world. The anthem of the Partners’ Forum was performed by MsAbelone, baby Zoey and MsTarana. The lyrics of this anthem were crowd-sourced from youth participants from around the world including India. The Partners’ Forum is co-hosted by Ministry of Health and Family Welfare and the Partnership of Maternal, Newborn and Child Health (PMNCH). The two-day event brings together more than 1200 participants from 85 countries in New Delhi, to deliberate on issues of health and well-being of women, children and adolescents. Partners’ Forum is a global health partnership launched in September 2005 to accelerate efforts to reduce child and maternal mortality, improve adolescent, child, newborn and maternal health. This partnership is an alliance of more than 1,000 plus members, across 10 constituencies in 92 countries: academic, research and teaching institutions; donors and foundations; health care professionals; multilateral agencies; non-governmental organizations; partner countries; global financing mechanisms and the private sector. The previous chapters were held in Johannesburg, South Africa (2014), New Delhi, India (2010) and Dar es Salaam, Tanzania (2007). This is the second time India is hosting the Partners’ Forum.   ]]> https://biospectrumindia.com/news/22/12252/unichem-labs-gets-tentative-nod-for-tadalafil-tablets.html https://biospectrumindia.com/news/22/12252/unichem-labs-gets-tentative-nod-for-tadalafil-tablets.html Wed, 12 Dec 2018 16:30:00 +0530 Pharma major, pleased to announce it has received a tentative approval from the US health regulator for generic Tadalafil tablets used for treatment of erectile dysfunction. The company has received the tentative approval from the United States food and Drug Administration for its Tadalafil tablets in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, Unichem Laboratories said in a filing to the BSE.  The tablets are used for treatment of erectile dysfunction (ED), signs and symptoms of benign prostatic hyperplasia (BPH), Unichem Laboratories said  The product is a generic version of Eli Lilly's Cialis tablets in the same strengths.  ]]> https://biospectrumindia.com/news/22/12231/india-day-inaugurated-by-ministry-of-health-family-welfare.html https://biospectrumindia.com/news/22/12231/india-day-inaugurated-by-ministry-of-health-family-welfare.html Mon, 10 Dec 2018 18:15:00 +0530 India Day which is an official side event organized jointly by the Ministry of Health and Family Welfare, and the development partners in the run up to the Partners’ Forum 2018 is inaugurated by Preeti Sudan, Secretary (HFW) today in Delhi. ‘India Day’ is aimed to reflect on the journey of the RMNCH+A programme and to share and learn from the good practices and innovations implemented by different States/UTs and organisations to address various health challenges around maternal and child health in order to sustain progress on global goals. Preeti Sudan, Secretary (HFW) inaugurated the ‘India Day’, an official side event organized jointly by the Ministry of Health and Family Welfare, and the development partners in the run up to the Partners’ Forum 2018, here today. Speaking at the function, she stated that, “flexibility has been at the core of all our initiatives in reproductive, maternal, newborn, child and adolescent (RMNCH+A) programme and a major contributor to its success. She further added that States have launched various innovative initiatives under RMNCH+A that encourage people to be partners in their own health and well-being.” Manoj Jhalani, Additional Secretary and Mission Director, stressed on the various aspect of RMNCH+A and stated that the Government recognizes the crucial significance of the first 1,000 in a child’s life. Our health cadres and midwifery services are geared at this. Equally, our focus is on children, adolescents and pregnant and lactating mothers, who we seek to strengthen through a series of initiatives like the Poshan Abhiyaan and Anaemia Mukt Bharat. The event’s sessions—conducted under the broad themes of community-based interventions, services and systems and enablers like use of data—highlighted the interventions that have worked well in states like Uttar Pradesh and Madhya Pradesh. The RMNCH+A strategy is centered on the continuum of care approach, catering to health needs at every stage of the lifecycle. RMNCH+A is aligned with the Global Strategy for Women’s, Children’s and Adolescents’ Health and its key programming tenets articulating well-defined targets to end preventable deaths, ensure health and well-being and expand enabling environments, popularly known as the Survive, Thrive and Transform approach. In India, maternal, child, neonatal and adolescent health gained tremendous momentum since RMNCH+A was rolled out. India’s maternal mortality rate (MMR) has fallen from 556 in the year 1990 to 130 in 2014–16 (SRS data). The country’s progress can be gauged from the 77% decline in MMR that it achieved during 1990­–2015, compared to global decline of 44% during this period. In child health also, India’s achievements have been strong. Under-five mortality rate (U5MR) in India has fallen significantly, from 126 per 1,000 live births in 1990 to 39 per 1,000 live births in 2016.   ]]> https://biospectrumindia.com/news/22/12224/niti-aayog-launches-global-hackathon-on-ai.html https://biospectrumindia.com/news/22/12224/niti-aayog-launches-global-hackathon-on-ai.html Mon, 10 Dec 2018 10:00:00 +0530 With the vision to further expand the idea of ‘Artificial Intelligence, AI for All’ articulated in the National AI Strategy, NITI Aayog organises hackathons to source sustainable, innovative and technologically-enabled solutions to address various challenges in the development space. Taking the initiative forward, NITI Aayog is now partnering with Perlin – a Singapore-based AI start up - to launch the ‘AI 4 All Global Hackathon’, and is inviting developers, students, start-ups and companies to develop AI applications to make significant positive social and economic impact for India. The challenge question seeks to develop solutions in Distributed Computing and Privacy Preserving techniques, such as multi-party computation, in AI. The objective of this hackathon is to promote awareness and subsequently develop solutions that deliver the twin benefit of efficient computing to address the infrastructure challenges, while also not compromising on privacy of data for training AI algorithms. NITI Aayog organized its first hackathon, ‘MoveHack’ in August, on the sidelines of the Global Mobility Summit 2018, with the aim of garnering cutting-edge mobility applications. Over 2,000 submissions were received out of which the Top 10 teams were awarded at the summit. “The AI for All Hackathon underscores the commitment of NITI Aayog to supporting meaningful social, economic and technological advancements directed at making people’s lives better,” said Amitabh Kant, CEO of NITI Aayog, “we believe India is ideally positioned as a thought-leader and regional economic power to help bring the benefits of innovation in AI and distributed computing to communities in developing countries around the world.” The ‘AI 4 All Global Hackathon’ was announced at the AI conference organized by NITI Aayog, in partnership with the ORF, held in Mumbai in November 2018. The hackathon will be run two stages with Stage One ending 15 January 2019 and Stage Two, which will only include shortlisted participants from the previous stage, will conclude on 15 March 2019. The jury shall comprise of the leaders from the technology and policy ecosystem, namely, Amitabh Kant, CEO, NITI Aayog; Michael Witbrock, Head at AI Foundations Lab IBM;  Anandamoy Roychowdhary, Director of Technology at Sequoia Capital; Prahbakar Reddy, Partner at Accel Partners; Professor AnupMalani, Co-founder & Faculty Director of International Innovation Corps; Ery Punta Hendraswara, Innovation Management at Telkom; and Dorjee Sun, CEO of Perlin. The first stage will invite ideas for use cases of multi-party computation in areas such as Healthcare, Education, Agriculture, Urbanization, Financial Inclusion. The second stage will call for these ideas to be matured and developed, with a focus on privacy preserving AI and distributed computing. Winners will share in a prize pool worth $50,000 in both cash and non-cash rewards. Participants will also get mentorship and support from the hackathon co-sponsors, including the opportunity to scale and implement their AI applications. ]]> https://biospectrumindia.com/news/22/12210/cabinet-approves-mou-between-india-japan-for-healthcare-and-wellness.html https://biospectrumindia.com/news/22/12210/cabinet-approves-mou-between-india-japan-for-healthcare-and-wellness.html Fri, 07 Dec 2018 11:05:00 +0530 The Union Cabinet chaired by Prime Minister Narendra Modi has given its ex-post facto approval on the Memorandum of Cooperation (MoC) between India and Japan in the field of Healthcare and Wellness signed on 29th October, 2018. The MoC covers the following areas of cooperation: (a) Promoting specific projects: Developing human resource in the field of acute medicine, surgery and trauma  care  including  focus  on new areas  of competency in each field; Establishing an advanced joint testing laboratory for clinical examination; Establishing a Japanese language education centre for trainee candidates of care workers; Establishing collaborations among tertiary care centres in both countries such as AUMS; and Supporting sending organisations to provide pre-lectures about elderly care for technical intern training programmes of care workers through sending out certificated care workers from Japan and providing a curriculum and textbooks so as to provide trained care-givers to Japan. (b) Development of infrastructure: Establishing a centralised management healthcare distribution centre; Improving sanitary environment by increasing access to hygienic and affordable toilets such as on-site processing one; Promoting institutional collaboration on patient data analysis and Information   and   Communication   Technology   &   Artificial Intelligence in medicine; India-Japan Innovation Hub in India; Establishing high end mobile BSL 3 Lab facilities in India; and Collaboration on getting high end medical devices including Point of Care Diagnostics with a special focus on establishing manufacturing units in India under "Make in India".  (c) Human development: Developing human resource, research and project promotion forhealth self-management such as ME-BYO and Ayurveda; and Holding an India-Japan public and private healthcare forum. (d) Any other areas as may be mutually decided upon to promote the synergies between AYUSHMAN Bharat Programme and other initiatives and AHWM; and (e) Any other areas as may be mutually decided upon to promote cooperation as envisaged under this MOC. A Joint Committee as a high-level consultative mechanism will be set up to further elaborate the details of cooperation and to oversee the implementation of this MoC.   ]]> https://biospectrumindia.com/news/22/12190/mtai-supports-cdsco-proposal-on-surgical-gowns-drapes.html https://biospectrumindia.com/news/22/12190/mtai-supports-cdsco-proposal-on-surgical-gowns-drapes.html Wed, 05 Dec 2018 14:10:00 +0530 The Central Drugs Standard Control Organization last week proposed to include surgical gowns and drapes under Drugs and Cosmetics Act, 1940 which will bring these products under the regulatory framework of the government. At present, 23 medical devices such as cardiac stents, orthopedic implants, intra-ocular lenses etc. are regulated under the said Act. CDSCO has sought stakeholders’ views on the proposal by 15th January. Medical Technology Association of India (MTaI) has welcomed the CDSCO proposal for inclusion of surgical gowns and drapes as medical devices and said it will ensure uniformity of quality in these product categories. Pavan Choudary, Chairman & Director General, MTaI said, “The inclusion of surgical gowns and drapes would ensure uniformity in the quality of products available in the market. Gowns and drapes come into direct contact of patients as well as healthcare professionals during the entire healthcare cycle, from diagnostic procedures to post-operative care. Hence, it is extremely important to ensure that only products of the highest quality are used.” “MTaI and its member companies look forward to work with CDSCO to streamline the transition to the new requirements as and when the proposal is implemented,” he added. MTaI further said that the Association will work with its member companies to ensure compliance of the regulations.     ]]> https://biospectrumindia.com/news/22/12182/government-committed-to-providing-quality-healthcare-within-outside-country-suresh-prabhu.html https://biospectrumindia.com/news/22/12182/government-committed-to-providing-quality-healthcare-within-outside-country-suresh-prabhu.html Wed, 05 Dec 2018 10:45:00 +0530 With an aim of presenting India as the most preferred healthcare destination for patients from across the globe, ‘Advantage Health Care - India 2018’ (4th International Summit on Medical Value Travel) was recently organised by FICCI jointly with the Department of Commerce, Ministry of Commerce & Industry, Government of India The dignitaries at the two-day conference and exhibition included Dilip Chenoy, Secretary General, FICCI; Dr Shohani Ramzi, Head International Relation, Health Ministry of Iraq; Suranjan Gupta, Executive Director, EEPC India; Dr Harish Pillai, Co-Chair – FICCI MVT Committee & CEO Aster Hospitals & Clinics, India at Aster DM Healthcare. The idea behind the summit is to provide an opportunity for India to showcase its immense pool of medical capabilities as well as help develop opportunities for healthcare collaborations between the participating countries. Visitors and delegates from over 71 countries are participating in the Summit. Speaking via video conferencing he said, “We have set aside almost Rs 5,000 Cr or approximately 700 million dollars for enhancing the overall services sector including healthcare.” “Government is committed to providing quality health care within the country and outside through promoting the service sector”, he also added. Sudhanshu Pandey, Additional Secretary, Ministry of Commerce and Industry, Government of India, said that it is extremely important that the healthcare facilities are affordable as only then more and more people can access quality healthcare. “Our efforts in India have been to reduce the cost of healthcare services, while we take our journey towards universal coverage, we try to offer and share our resources with the global citizens,” he added. “India itself carries a very large disease burden and is trying to come up with programs and policies, latest one being Ayushman Bharat Scheme, where effort have been made to extend a wide insurance coverage to the Indian citizens numbering over 500 million so that they can have access to better health care facilities”, he added. On the occasion ‘FICCI-EY Knowledge Paper on Medical Tourism in India’ was also released by FICCI in association with Ernst and Young. Sangita Reddy, Vice President, FICCI & Executive Director Apollo Hospitals Group said, “India is unparalleled in delivering quality medical care at one tenth of the global cost, and aims to transform this sector so that India becomes an epicenter of Medical Value Travel.”  She further added that we will continue to work on better facilities, translation, food, and outstanding medical services for our foreign patients. Our doors are open, our hearts are open, and our facilities are on par with the best. Dr Devlina Chakravarty, Co-Chair-FICCI MVT Committee & MD, Artemis Hospitals said that, “India has more than 1600 NABH accredited facilities, & 32 JCI accredited hospitals. Cost is not the only differentiator for India when it comes to medical value travel, we’re also known for our talent.” Some of the key points of ‘FICCI-EY Knowledge Paper on Medical Tourism in India’: Asia accounts for the 58% share of total disease burden, while Africa stands at 24%, indicating the disease burden stress to be highly prominent in Asian region. The largest disease burden comes from cardiovascular diseases which accounts for 14-15% of the total. This is followed by cancers, mental and neurological disorders, new born complications and other NCDs. Diarrhea and other infectious disease also account for 10%. MVT is a burgeoning multi-billion dollar industry and likely to grow higher due to many benefits offered to patients. 95% of the medical travelers from Africa prefer travelling to Asia for medical treatments. A high-quality treatment at lower healthcare costs coupled with the possibility to travel to exotic places made Asia the preferred region for foreign medical travelers. India, Malaysia, Thailand and Singapore are the most preferred countries for medical treatments globally due to advanced quality healthcare and affordable healthcare costs. Countries like Costa Rica, Mexico, Barbados and Antigua are expanding their services faster thus attracting patients from North America and Europe. The UAE is also developing itself as MVT hub by promoting developments in Dubai. Huge amounts of investment have been made in Dubai by the government, as it envisages itself as the medical hub in coming years. The lowest spending by the government has been observed in countries like Bangladesh and Myanmar indicating inadequate medical infrastructure. Thus, the inadequate infrastructure in source countries and higher prices of healthcare in developed economies like US and Canada, becomes the high potential region where India can focus for the development of MVT. ]]> https://biospectrumindia.com/news/22/12172/ppp-could-be-the-model-for-providing-better-rural-healthcare-vice-president.html https://biospectrumindia.com/news/22/12172/ppp-could-be-the-model-for-providing-better-rural-healthcare-vice-president.html Mon, 03 Dec 2018 17:45:00 +0530 The Vice President of India, M.Venkaiah Naidu recently inaugurated GEM hospital in Chennai. While addressing the gathering, urged doctors to visit universities and colleges to create greater awareness among students on the need for regular physical activity, eating healthy food and avoiding consumption of alcohol and tobacco. The Chief Minister of Tamil Nadu, Edappadi K. Palanisamy, the Deputy Chief Minister of Tamil Nadu, O. Panneerselvam, the Minister for Fisheries and Personnel and Administrative Reforms, Tamil Nadu, D. Jayakumar, the Minister for Transport, Tamil Nadu, M.R. Vijayabhaskar, the Founder of GEM Hospitals, Dr. C. Palanivelu and other dignitaries were present on the occasion. He called upon the medical fraternity to launch nationwide awareness campaign on the health hazards posed by modern lifestyle in view of the growing incidence of non-communicable diseases. He urged the private sector to make medical treatment accessible and affordable to the common man and expressed concern over the rising cost of healthcare services and added that there have been instances in which families have been driven to penury or burdened by debts because of the high costs of treatment. Naidu said that, “despite the efforts of governments in states and centre, healthcare faces formidable challenges in terms of low public spend, low doctor-patient ratio, low patient-bed ratio, rising out-of-pocket expenditure, dearth of medical colleges and trained doctors, inadequate infrastructure in rural areas.” “Such challenges cannot be met by governments alone and called upon the private sector to focus more on improving health infrastructure in rural areas. The rural-urban disparity in healthcare and insurance is adding to the financial burden of the people”, he added. Expressing concern that doctors were not spending the required time with the patients unlike in the past when the family physician used to do, the Vice President urged doctors to provide comfort to those who come to them in times of distress. You must always treat patients with empathy and provide them the much-needed human touch and healing touch, he added. “Aayushman Bharat programme launched by the government of India would be a boon to needy and poor families in the country and would help improve the health outcomes, particularly in the rural areas. Establishment of 1.5 lakh health and wellness centres across the country aim to provide holistic healthcare”, he added. The Vice President also said that Public Private Partnership could be the model to bridge the gap by providing technically advanced primary and secondary healthcare centres that act as the first response units to combat diseases or general ill health.     ]]> https://biospectrumindia.com/news/22/12165/government-is-fully-funding-hiv-aids-programme-anupriya-patel.html https://biospectrumindia.com/news/22/12165/government-is-fully-funding-hiv-aids-programme-anupriya-patel.html Mon, 03 Dec 2018 12:05:00 +0530 Government is not only fully funding the HIV/AIDS programme but also increasing the resource envelope in accordance with the programme needs.” This was stated by Anupriya Patel, Minister of State (Health & Family Welfare) at a function to mark World AIDS Day, 2018 organised by the National AIDS Control Organisation (NACO), Ministry of Health and Family Welfare, recently in New Delhi. At the function, Anupriya Patel also released the Operational Guidelines on HIV/TB Intervention in Prisons and NACO Calendar for 2019. Sanjeeva Kumar, AS & DG (NACO), Alok Saxena, JS (NACO), Dr. Billali Camara, Country Coordinator, UNAIDS and Dr. Benk Henkedam, WHO Country Representative to India also graced the occasion. Speaking at the event, Anupriya Patel informed that the HIV/AIDS Programme has focused on more than one million people from high risk group and kept the infection of HIV in control through comprehensive and intense targeted interventions services.  “The Programme has also given attention to eliminating mother to child transmission of HIV and Syphilis by 2020. Under the Pradhan Mantri Surakshit Matritva Abhiyan complete ante-natal check up facility is provided to all pregnant women across the country, including HIV testing.  In 2017-18 more than 2 Crore HIV testing among pregnant women was undertaken,” she added. Reiterating the commitment to end the epidemic by 2030, Anupriya Patel stated that the National programme has laid a great emphasis on counseling and testing among general clients and NACO has initiated community based screening of HIV to reach first 90 out of the target 90:90:90 by 2020. She further said that with the launch of ‘Test and Treat’ in 2017, every PLHIV is eligible to be put on ART as soon as he/she is detected HIV positive irrespective of the CD4 count and today 70% of PLHIV who know their HIV status are on ART. “The Viral Load testing for all PLHIV who are on ART has been launched. More than 12 Lakh PLHIV have already benefitted from it. Viral load testing is of immense importance to monitor the effectiveness of treatment of patients taking lifelong Antiretroviral therapy,” she mentioned. The Minister further said that in a historic move, the HIV/AIDS (Prevention and Control) Act, 2017 was unanimously passed by the Government and it has also come into force. “This Act provides an enabling environment to HIV affected and infected population where they get a seamless access to services and a comprehensive grievance redressal mechanism with ombudsman at the Centre and Complaints Officer at establishments, she added. Stressing on the need for multi-faceted and multi-sectoral response, Anupriya Patel stated that NACO has signed Memorandum of Understanding (MoU) with 16 key Ministries to augment a comprehensive AIDS response. In addition to this NACO has signed MoUs with more than 250 industries of public and private sectors to mobilize their support. Anupriya Patel also paid tributes to all the lives lost to HIV/AIDS not just in India but globally. The event concluded on the note of renewed commitment to the cause of HIV by the government and each and every partner who have contributed to the successful halting of the HIV epidemic in the country.   ]]> https://biospectrumindia.com/news/22/12150/the-government-is-committed-to-health-wellbeing-for-all-anupriya-patel.html https://biospectrumindia.com/news/22/12150/the-government-is-committed-to-health-wellbeing-for-all-anupriya-patel.html Thu, 29 Nov 2018 20:40:00 +0530 “The Government is committed to the attainment of highest possible levels of health and wellbeing for all its citizens and providing “Healthcare for All.” This was stated by Anupriya Patel, Minister of State for Health and Family Welfare at the 15th India Health Summit, an annual flagship event on healthcare, organized by the Confederation of Indian Industry (CII), at New Delhi recently. The theme of this year’s summit is ‘Indian Healthcare – Changing Paradigm.’ At the function, Anupriya Patel also released a report, ‘Creating the New Ecosystems to Provide Healthcare.’ Anupriya further stated that one of the biggest policy initiatives was the release of National Health Policy, 2017 after a gap of fifteen long years which paves the way for Universal Health Coverage and reduction of out-of-pocket expenses. She said that the other policy achievements in the past four years include the Mental Healthcare Act, 2017 and HIV/AIDS (Prevention and Control) Act 2017, MCI Ordinance. Highlighting other achievements of the Ministry, Anupriya further said the Government’s new schemes and programs have contributed to changing the health scenario of the country. She added that Mission Indradhanush yielded very encouraging results which has made us set our target date of bringing 90% full immunization rate in the country to 2018, much before the target date of 2020. Five new vaccines have been added to India’s Universal Immunization Program, bringing the total to twelve, she said. The Minister further informed that the Pradhan Mantri National Dialysis Programme is providing free dialysis services to the poor in the district hospitals in PPP mode and AMRIT Pharmacies provide drugs and implants for cancer patients and cardiovascular diseases at 60 to 90% discount than the prevailing market rates. Speaking further on Ayushman Bharat, Anupriya Patel said that it is a step towards fulfilling the vision of National Health Policy, 2017 and adopts a continuum of care approach through it two pillars. The 1stpillar being Health and Wellness Centre aimed at bringing healthcare to the homes of people and under it 1.5 lakh subcentres and primary healthcare Centres across the country would be transformed into Health and Wellness Centres, she added. Anurpiya further elaborated that the 2ndpillar is Ayushman Bharat- PradhanMantri Jan ArogyaYojana (PMJAY) that provides insurance cover of Rs 5 lakhs per annum for secondary and tertiary care hospitalization to more than 10 crorepoor and vulnerable families across the country. This is a holistic initiative in the public health sector aimed at fixing the current fragmented and inequitable healthcare system of providing continuum of care covering primary, secondary and tertiary aspects of healthcare along with financial risk protection to the poor. “Ayushman Bharat is being implemented at unprecedented scale to build new India by 2022 and will bring paradigm shift in India’s healthcare sector. This holistic and comprehensive approach towards healthcare will definitely achieve the goal of “Health for all’’, she mentioned. ]]> https://biospectrumindia.com/news/22/12119/health-ministry-launches-new-health-information-platform.html https://biospectrumindia.com/news/22/12119/health-ministry-launches-new-health-information-platform.html Tue, 27 Nov 2018 10:55:00 +0530 Preeti Sudan, Union Health Secretary did soft-launch of the Integrated Disease Surveillance Programme (IDSP) segment of Integrated Health Information Platform (IHIP) in seven states recently. The path-breaking initiative will provide near-real-time data to policy makers for detecting outbreaks, reducing the morbidity and mortality and lessening disease burden in the populations and better health systems. The first one-of-its-kind initiative by the Government of India, IHIP uses the latest technologies and digital health initiatives. Speaking on the occasion, Preeti Sudan stated that the success of this platform will depend primarily on the quality of data shared by the states. “Data is power and power is to help people,” she said. She urged the state secretaries to be earnest in adopting this platform to strengthen early outbreak detection and informed public health response. She also shared that for effective implementation of the platform, 32,000 people at the block level, 13,000 at the district level and 900 at the state level have been trained. Preeti Sudan, Union Secretary of Health also launched the IHIP vision and a ready-reckoner developed to navigate the platform. Congratulating the government for making this ambitious undertaking a reality,  Dr Henk Bekedam, WHO Representative to India said that it is imperative to collaborate with the private sector to ensure the sustainability of this initiative. “For WHO, it has been a privilege to support the development of the platform in collaboration with numerous government stakeholders,” he added. Among those present at the launch were Lav Aggarwal, Joint Secretary; VikasSheel, Joint Secretary, Dr Sujeet Kumar Singh, Director NCDC; Dr Henk Bekedam, WHO Representative to India; Dr Ramesh Krishnamurthy, Senior Advisor, WHO HQ; Dr Pradeep Khasnobis, Joint Director, IDSP NCDC and senior officials in the Union Health Ministry. Additional Chief Secretaries/Principal Secretaries (Health) and Mission Directors from the seven states (Andhra Pradesh, Himachal Pradesh, Karnataka, Kerala, Odisha, Telangana and Uttar Pradesh )participated in the launch through video-conferencing. ]]> https://biospectrumindia.com/news/22/12120/information-platform-to-monitor-public-health-surveillance-launched-by-health-ministry.html https://biospectrumindia.com/news/22/12120/information-platform-to-monitor-public-health-surveillance-launched-by-health-ministry.html Tue, 27 Nov 2018 10:55:00 +0530 Soft-launch of the Integrated Disease Surveillance Programme (IDSP) segment of Integrated Health Information Platform (IHIP) was recently launched by Preeti Sudan, Union Health Secretary in seven states recently. This initiative aims to provide near-real-time data to policy makers for detecting outbreaks, reducing the morbidity and mortality and lessening disease burden in the populations and better health systems. The first one-of-its-kind initiative by the Government of India, IHIP uses the latest technologies and digital health initiatives.  Lav Aggarwal, Joint Secretary; Vikas Sheel, Joint Secretary, Dr Sujeet Kumar Singh, Director NCDC; Dr Henk Bekedam, WHO Representative to India; Dr Ramesh Krishnamurthy, Senior Advisor, WHO; Dr Pradeep Khasnobis, Joint Director, IDSP NCDC and senior officials in the Union Health Ministry were present at the launch. Speaking on the occasion, Preeti Sudan stated, “The success of this platform will depend primarily on the quality of data shared by the states. Data is power and power is to help people.” She urged the state secretaries to be earnest in adopting this platform to strengthen early outbreak detection and informed public health response. “For effective implementation of the platform, 32,000 people at the block level, 13,000 at the district level and 900 at the state level have been trained”, she added. The IHIP vision and a ready-reckoner developed to navigate the platform was also launched by her. Congratulating the government for making this ambitious undertaking a reality, Dr Henk Bekedam said, “It is imperative to collaborate with the private sector to ensure the sustainability of this initiative.” “For WHO, it has been a privilege to support the development of the platform in collaboration with numerous government stakeholders,” he added. Additional Chief Secretaries/Principal Secretaries (Health) and Mission Directors from the seven states (Andhra Pradesh, Himachal Pradesh, Karnataka, Kerala, Odisha, Telangana and Uttar Pradesh) participated in the launch through video-conferencing.   ]]> https://biospectrumindia.com/news/22/12094/cabinet-apprised-of-agreement-between-india-and-uzbekistan-for-st.html https://biospectrumindia.com/news/22/12094/cabinet-apprised-of-agreement-between-india-and-uzbekistan-for-st.html Fri, 23 Nov 2018 09:40:00 +0530 The Union Cabinet chaired by the Prime Minister Narendra Modi has been apprised of an Agreement on Cooperation in the field of Science, Technology and Innovation between India and Uzbekistan. The Agreement was signed in the month of October at New Delhi in the presence of the Prime Minister of India and Shavkat Mirayoyev,President of Uzbekistan by Dr. Harsh Vardhan, Minister for Science & Technology and Earth Sciences on the Indian side and Ibrohim Abdurakhmanov, Minister of Innovative Development on the Uzbek side.    Signing of the Agreement will open a new chapter in bilateral relations, as both sides will now leverage complementary strengths spurred by a significant convergence of mutual interests in science and technology. The objective of the Agreement is to promote cooperation in the fields of science, technology and Innovation between the two countries. The stake-holders will include researchers from scientific organizations, academia, R&D laboratories and industries from India and Uzbekistan. Agriculture and Food Science and Technology; Engineering Sciences; Information and Communication Technology, Applied Mathematics and Data Science and Technology; Health and Medical Technology; Materials Sciences; Life Sciences & Biotechnology; Physics and Astrophysics and Energy, water, climate and natural resources were identified as potential areas for immediate collaboration.   ]]> https://biospectrumindia.com/news/22/12093/importers-lobby-misleads-goi-on-affordable-healthcare.html https://biospectrumindia.com/news/22/12093/importers-lobby-misleads-goi-on-affordable-healthcare.html Thu, 22 Nov 2018 18:00:00 +0530 Reacting to a press statement by the Importers lobby asking one-time increase of upto 18% in MRPs of medical devices, including stents and orthopedic knee implants, Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD) said that it is shocking to see how Importers Lobby on one side states that Trade Margins are excessive & need to be rationalized and capped and at the same time they wish MRP on Medical Devices to be increased by 18% for all devices. Nath lashed out at the Importers Lobby for misleading GoI against its mission of making Healthcare Affordable in India. If trade margins are not rationalized including the importers margin the consumers will suffer and if MRP is increased then also the consumers will suffer as the MRP is already excessively high. “Importers lobby is least concerned about making healthcare affordable for Indian consumers & Indian Medical Device Industry but  thinks only for protecting their own profits” added Nath. As Govt doesn’t control import price or importers price to hospitals, so what’s stopping the importers to increase that to compensate themselves for cost increase?  The reason behind it is the competition from domestic manufacturers whose prices are not up which importers wish to counter by keeping retailers and traders satisfied with higher remunerative MRP and  trade margins. According to the recent estimates of the National Pharmaceutical Pricing Authority (NPPA), patients across the country have saved around Rs 15,000 crore under the government’s initiative of ensuring affordable, quality medicines for all. Much more can be saved by patients if Niti Aayog and PMO act on AIMED’s recommendations on price controls. The question Parliamentarians should be asking the government is what’s the opportunity cost of higher costs borne by patients for not acting on AIMED’s recommendations to cap trade margins to 75% over the import landed price and Indian manufacturers ex-factory price. Indian manufacturers seek Preferential Market Access by preferential pricing as is permissible under WTO, reasonable Tariff Protection, Price Controls and strong deterrents like punishment to errant companies engaged in unethical marketing practices to boost domestic manufacturing. Price controls can be done in a calibrated manner through: 1% GST Cess on MRP as a Tax based disincentive; Capping Trade Markups  to a Rational Level; & Price Caps on few Priority Devices Make in India of medical devices is already suffering and following MTAI recommended formula will make Indian Mfg at a further competitive disadvantage - GoI needs to take policy decisions to give strategic advantage to domestic Mfg while safeguarding consumers or India will remain 70-90% import dependent. Only when it will be advantageous to manufacture in India only then will these importer / Overseas manufacturers move manufacturing to India to retain market share and gain from that competitiveness created and initially enjoyed by domestic manufacturers. We welcome the induction of the new NPPA Chairwoman Shubhra Singh. We hope she will have the freedom to provide leadership to NPPA as done by respected Bhupendra Singh and usher in reforms and much needed amendments to DPCO as currently it doesn’t address huge price disparity among similar medical devices and in fact increases it year over year. "There is an urgent need for an integrated and calibrated development policy to put ‘Make In India’ initiative in medical devices  sector in top gear and reduce high import dependency on foreign made devices in order to promote indigenous manufacturing of drugs and devices which would go a long way in making healthcare affordable." Said Nath. There have been enough reports in newspapers of unaffordable hospital bills and exorbitantly priced medical devices used in treatment which has created distrust in healthcare industry. In the absence of fair competition to drive down pricing and options of choice of brand to consumers as is usually the case in a free market space, reasonable Price Controls are desired and one possible solution is keeping Trade Markups at a Rational Level along the Supply Chain.  What’s to be seen is, does Govt listens to this powerful lobby who wish to retain their market share or thinks about the needs of Indian consumers by ensuring affordable access to reasonably priced Medical Devices and is serious about having a robust domestic medical devices industry who is refraining from proportionately increasing ex-factory prices in hope to gain market share. ]]> https://biospectrumindia.com/news/22/12073/mtai-demands-one-time-hike-in-prices-of-medical-devices.html https://biospectrumindia.com/news/22/12073/mtai-demands-one-time-hike-in-prices-of-medical-devices.html Tue, 20 Nov 2018 16:35:00 +0530 Medical Technology Association of India (MTaI) released a statement saying that the government should allow a one-time increase of upto 18% in MRPs of medical devices, including stents and orthopedic knee implants, as rupee depreciation and inflation have raised their cost to companies. Rupee has depreciated 13.13% against the US dollar and 12.33% against Euro in last one year. Wholesale price inflation has hovered between 4% and 5% during this period. The current regulatory framework in India mandates price ceiling for scheduled devices like stents and orthopedic knee implants and allows only upto 10% increase in Maximum Retail Prices (MRPs) of regulated non-scheduled devices like catheters, heart valves, etc.   The government had fixed price ceiling for stents and knee implants in 2017 based on landed cost of these devices in India. The rupee depreciation has increased the landed cost by around 14%. Pavan Choudary, Chairman and Director General, MTaI said, “The dual effect of weakening of currency and inflationary trends is creating an extra-ordinary situation and the medical device companies are finding it increasingly difficult to sustain the supply of medical devices in the present situation. Long-term cross subsidization to keep the supplies is not healthy for the growing medtech sector. The present situation calls for an increase in our net realized prices.” Para 19 of Drug Price Control Order (DPCO) 2013 allows the government to revise the prices of drugs under extra-ordinary circumstances. “The government should allow a 14-18% increase in the ceiling price of all notified medical devices (including stents and knee implants) this year and not stick to the 10% ceiling on MRPs as per the DPCO 2013 given the unprecedented depreciation of the rupee and other inflationary trends”, he added   He also said, “MTaI believes unreasonably high trade margins are a major contributor to the increased MRP of medical devices. This is supported by 4 independent government reports namely, CCI- Policy Note on Affordable Healthcare (October 2018); NITI-Aayog’s Concept Note on Medical Devices (July 2018); NPPA’s report on overcharging by hospitals (February 2018) and Report of the Committee of High Trade Margin in the Sale of Drugs, 2016 (DOP Report). MTaI strongly recommends Trade Margin Rationalization from first point of sale, which is the price to the distributor, as recommended by DOP Report and as suggested by NITI Aayog’s concept note, as this could bring in affordability. It would also ensure the continued availability of medical devices and investments in capacity building in this sector, which is crucial for the success of Ayushman Bharat (PMJAY). The trade margin rationalization should replace any suboptimal regulatory instruments such as price control.”   ]]> https://biospectrumindia.com/news/22/12047/dbt-cancer-research-uk-sign-mou-for-cancer-research.html https://biospectrumindia.com/news/22/12047/dbt-cancer-research-uk-sign-mou-for-cancer-research.html Mon, 19 Nov 2018 10:00:00 +0530 A Memorandum of Understanding (MoU) for the partnership between Department of Biotechnology (DBT) and Cancer Research UK for the India-UK Cancer Research Initiative was signed recently in New Delhi. The India-UK Cancer Research Initiative is a collaborative 5-year bilateral research initiative by the Department of Biotechnology, Ministry of Science & Technology, India and Cancer Research UK (CRUK) that will focus on affordable approaches to cancer. Both CRUK and DBT will invest £5 million each in this 5-year pilot, and seek further investment from other potential funding partners. The India-UK Cancer Research Initiative will identify a core set of research challenges that address issues of affordability, prevention and care of cancer by bringing together leading Indian and UK experts across clinical research, demographic research, new technologies and physical sciences. The initiative will provide funding to develop new research alliances and undertake impactful research to enable significant progress against cancer outcomes. Speaking at the launch of this initiative, Secretary, DBT, Dr. Renu Swarup, said, “Cancer is a global epidemic that requires radically new approaches through inter-disciplinary and multi-national efforts. The India-UK Cancer Research Initiative will provide a catalyzing platform for scientists and researchers in the United Kingdom and India to co-create solutions for affordable cancer care that improve cancer outcomes around the globe. At DBT our priority is to apply science to solving complex challenges that benefit all humanity and we are glad to be partnering with CRUK to support research across all stages of cancer from prevention to cure to address the formidable challenge of cancer.” ]]> https://biospectrumindia.com/news/22/12046/odisha-launches-biotech-policy-2018-to-attract-stakeholders.html https://biospectrumindia.com/news/22/12046/odisha-launches-biotech-policy-2018-to-attract-stakeholders.html Fri, 16 Nov 2018 17:30:00 +0530 The State Government released its ‘Biotech Policy 2018’ that showcased the immense potentials and opportunities in the biotechnology sector to attract domestic and international investors at the Make in Odisha Conclave here. “Development in the biotechnology sector will be based on three key pillars - innovation, entrepreneurship and investment. We will provide our full support for the development of this sector by forming public-private partnerships, bio incubation centres and biotech finishing schools. We will collaborate with various international organizations to provide cutting-edge technology in the biotech sector," said Science and Technology Minister Badri Narayan Patra at the ongoing Make in Odisha Conclave. As per the policy, all biotechnology units shall be allotted land at a concessional rate as per the Industrial Policy Resolution of the state government. Besides, an additional subsidy of 25 per cent shall be available to reputed anchor tenants. In the policy, we have provided attractive incentives for stakeholders to invest in Odisha. By collaborative efforts between Government of Odisha and private stakeholders, we aim to make Odisha a top biotech investment destination in the country,” said Badri Narayan Patra.  In his speech, Chief Secretary AP Padhi also assured that the State Government would provide an essential platform to stakeholders who want to invest in the biotechnology sector in Odisha. He said a centre of excellence would be set to support the biotechnology sector in the State. Padmabhushan Prof G Padmanabhan, Senior Science and Innovation Advisor of the Biotechnology Industry Research Assistance Council (BIRAC), suggested six significant steps to make Odisha a biotechnology hub. He suggested for the adoption of needleless delivery of vaccine, concentrate on the development of Nanobodies, biomass conversion, eliminating malaria through biological route, gene editing and synthetic biology. Dr. Krishna Ella, Founder of Bharat Biotech, said that Odisha's Biotech Policy Is best in the country. He expressed his intention reaching Rs 500 crore investment by the Bharat Biotech. There was an interesting panel discussion on the topic 'Odisha in the biotech/medtech realm', which saw participation from various eminent speakers like ILS Director Dr. Ajaya Parida and PATH Impact Lab Director Dr. SP Dash, among others.   ]]> https://biospectrumindia.com/news/22/12031/impact-of-gst-positive-on-pharma-sector-mansukh-mandaviya.html https://biospectrumindia.com/news/22/12031/impact-of-gst-positive-on-pharma-sector-mansukh-mandaviya.html Thu, 15 Nov 2018 12:50:00 +0530 Impact of Goods and Services Tax (GST) on Pharma sector has largely been positive and constructive, informed Minister of State for Road Transport, Highways, Shipping and Chemicals & Fertilizers, Mansukh Mandaviya, in a recent statement. Following the vision of Prime Minister of India, Narendra Modi, to ensure health security for all citizens of India, the Ministry of Chemicals & Fertilizers has taken various steps to ensure availability of ‘Affordable, Quality Medicines for All’, the Minister added. In this background, Mandaviya informed that the Pharma sector has seen a positive growth after the implementation of GST. This is evident from the following:- Before GST, Annual Turnover of the Pharma Sector (as on 31.05.2017) was Rs 1,14,231 crores while after GST, the Annual Turnover of Pharma sector (as on 31.05.2018) touched Rs 1,31,312 crores, which is 6% higher than the Pre-GST regime. Exports from Pharma Sector during 2016-17 were Rs 2,75,852 crores while post-GST, in the year 2017-18, they were recorded at Rs 3,03,526 crores, which is 10% higher than the Pre-GST Regime. The Minister added that as per estimates, the export figure for the current year is likely to be Rs 3,27,700 crores, which will be almost 12% higher than the export figure of Pre-GST regime (2016-17). Further, it was informed that there has been a significant jump in number of Drug Approvals from 7,857 before GST (01.07.2016 to 30.06.2017) to 10,446 post-GST (01.07.2017 to 30.06.2018). Elaborating on the reasons for this positive impact post-GST, Mandaviya said that under the ‘One Nation, One Tax’ regime, the removal of complexity of multiple taxes has reduced their cascading effect on the final product. GST is expected to decrease the manufacturing cost in view of merging of different taxes levied earlier and promote ease of doing business. It will create one single market for all stakeholders with equal chance towards development. Mandaviya informed that due to discontinuation of Central Sales Tax post-GST, it will reduce transaction costs, as inter-state transaction between two dealers will become tax neutral. Now, the pharma companies can consolidate their warehouses at strategic locations, effecting a reduction in cost of distribution. As a result, it will benefit warehouse strategy and improve supply chain efficiency in pharma sector, the Minister explained. ]]> https://biospectrumindia.com/news/22/11966/nadda-applauds-himachal-govt-for-growth-in-healthcare-sector.html https://biospectrumindia.com/news/22/11966/nadda-applauds-himachal-govt-for-growth-in-healthcare-sector.html Mon, 05 Nov 2018 11:00:00 +0530 Jagat Prakash Nadda, Union Health Minister appreciated the Himachal Pradesh government's efforts towards improving the state's healthcare sector. The minister said that Himachal Pradesh has been rated as the best performing state in the healthcare sector India.  Nadda applauded the Himachal government for its excellent performance at the national level in the health sector, saying that at the fifth national conference held on October 30, 2018 in Kaziranga, Assam on good work and renewal in the field of health, the state was lauded as the best performing states in India.  He said that due to the vision and effective efforts of Prime Minister Narendra Modi, there has been a major change in the policy changes in the country.  The Prime Minister's efforts were the reason behind India jumping for the second consecutive year in business accessibility (ease of doing business).  In the list released by the World Bank, India has secured 77th position with improvement of 23 positions this year. India was at the 100th place last year.  He said, "When Prime Minister Narendra Modi took over the reins of governance, India's position in the ease of business was 143rd. With the efforts of the Prime Minister, the country has reached 77th position and will soon make its place in the first 50 countries." Nadda was speaking in Dharamshala  on Friday while chairing the cooperation and contact programme organised on the occasion of the launch of 'MSME 59 Minutes Portal' (from New Delhi) for the Micro, Small and Medium Enterprises. Food and Supply minister of Himachal Kisan Kapoor and industry minister Bikram Thakur were also present on the occasion. Anuradha Thakur, Joint Secretary, Ministry of Finance, also attended the event.  The Union Health Minister said that in order to set up mass development in the country, the emphasis is on providing all the facilities. For the purpose, this portal has been started for facilitating loan clearance for small and medium enterprises only in 59 minutes.  He said that 45 per cent contribution of total production in the country is of micro, small and medium enterprises and this region accounts for 40 per cent of the share of exports. Prime Minister Narendra Modi has not only taken care of the people who work in the unorganised sector but also took concrete steps to improve their lives and provide protection and facilities.  Pradhan Mantri Jeevan Bima Yojana, Mudra Yojana, Ayushman Bharat Scheme are some of the many initiatives taken in this direction, he said. Nadda said that under the Ayuhman Bharat Scheme, 10.74 million poor and deprived families of the country got the strength of healthcare and about 55 million poor people, who were unable to get treatment due to high expenses, got the facility of health insurance of Rs 5 lakhs. Himachal Industry Minister Bikram Thakur said the Himachal government has started several schemes to promote micro, small and medium enterprises. The government is making a decision that all schemes of public welfare should be properly grounded, he said.   ]]> https://biospectrumindia.com/news/22/11963/68-drug-formulations-pricing-set-by-nppa.html https://biospectrumindia.com/news/22/11963/68-drug-formulations-pricing-set-by-nppa.html Mon, 05 Nov 2018 09:00:00 +0530 Drug price regulator National Pharmaceutical Pricing Authority (NPPA) has fixed prices as well as revised ceiling and retail prices of 68 formulations, including those used for treatment of diabetes, blood pressure and HIV. According to NPPA, while the retail price of 55 scheduled formulations has been fixed, that of 10 has been revised. Further, the authority has also fixed ceiling prices of three scheduled formulations. NPPA has fixed or revised ceiling prices or retail prices of 68 formulations under Drugs (Prices Control) Order, 2013. ]]> https://biospectrumindia.com/news/22/11943/5th-national-summit-on-public-health-care-starts-in-assam.html https://biospectrumindia.com/news/22/11943/5th-national-summit-on-public-health-care-starts-in-assam.html Wed, 31 Oct 2018 12:15:00 +0530 JP Nadda, Union Minister of Health and Family Welfare in the presence of Sarbananda Sonowal, Chief Minister of Assam, inaugurated the 5th National Summit on Good & Replicable Practices & Innovations in Public Healthcare Systems in India at Kaziranga, Assam. A coffee table book with brief description of all practices and products selected for dissemination in the summit, along with contact details for further information, is released and later uploaded on the National Health Innovation portal for public information. Speaking at the function, Chief Minister of Assam said that everybody will benefit from these best practices and there is a need to raise awareness amongst the masses about various health issues for ensuring a better future. Speaking at the function, Nadda said that the government is always focused on promoting innovative approaches tailored to challenges under the most able leadership of our Hon’ble Prime Minister who has given the mantra of Reform, Perform and Transform.  He further said that we must match speed, skill and scale to get the desired results. The Union Health Minister said that the Government believes in cooperative federalism. “The Health Ministry stands with the states. While the ownership is that of the states, we are ready to lend all technical and financial support,” he said. Nadda also emphasized on the need for IT initiatives in the health sector.  “They can help address gaps where we have challenges of HR, or aid accurate and quick diagnosis to improve clinical decision making particular for remote locations. National Health Mission is also supporting many IT initiatives in States,” He further said that the best practices that have been selected on mHealth and digitalization will provide learnings for other states to adopt the innovations. Ashwini Kumar Choubey, Minister of State for Health and Family Welfare in his speech said that many exemplary practices have been undertaken in many states to meet healthcare goals and the center stands committed to supporting the state/UTs in their innovative endeavours. He also said that 15,000 Health and Wellness Centers across the country will start operating soon. The Health Ministry also gave away awards to the states for best performances. The award for Highest Annual Decline in Neonatal Mortality Rate 2015 vs 2016 among states was given to Himachal Pradesh – 1st  (- 15.8%), Tamil Nadu 2nd (-14.3%) and Delh-3rd (-14.3%). The award for highest annual decline in Infant Mortality Rate was given to Kerela-1st (-16.7%), Mizoram-2nd (-15.6%) and Karnataka-3rd (-14.3%). The award for highest annual decline in Under 5 Mortality was given Himachal Pradesh-1st (-18.2%), Assam-2nd (-16.1%) and Jharkhand, Gujarat and Kerela (-15.4%). For best performance in Family Planning awards, were given to West Bengal, Chattisgarh and Rajasthan. For best performance in RNTCP, awards were given to Andhra Pradesh, Gujurat and Arunachal Pradesh while in NLEP award was given to Gujarat in category of State and Dadar& Nagar Haveli in the category of Union Territory. Awards for best performance in National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS), were given to Haryana and Himachal Pradesh. The award for best performing States in the category of indoor services (based on change of IPD/1000 population from 2016-17 to 2017-18-HMIS) was given to Goa, Karnataka and Himachal Pradesh. Lakshadweep got the award among the Union Territories (UTs).   ]]> https://biospectrumindia.com/news/22/11919/-goi-to-build-a-larger-digital-healthcare-ecosystem-nadda.html https://biospectrumindia.com/news/22/11919/-goi-to-build-a-larger-digital-healthcare-ecosystem-nadda.html Fri, 26 Oct 2018 17:20:00 +0530 India’s focus on improved and strengthened primary and secondary health care services with stress on multiple sectors have yielded results not just in terms of positive health indicators but also in a robust health system, Union Health Minister J P Nadda said Thursday. was speaking on the theme ‘The Future of Primary Health Care’ at the plenary session of ‘2nd International Conference on Primary Health Care (PHC) towards UHC and SDGs’ at Astana in Kazakhstan. “The Union Health Minister said India has focused on improved primary health care services and established referral linkages including transport and strengthened secondary care services, which have largely focused on maternal, newborn, nutrition, child health and communicable disease. “Nadda further said that this focus has yielded results, not just in terms of positive health indicators, particularly for those that are primary health care sensitive, but in a robust health systems platform that now gives us the confidence to move from selective to comprehensive primary health care services”. He said India’s progress in making improvements in maternal, child health and communicable diseases is largely due to the country’s sustained focus on and investing in strengthening health systems for these services. Nadda said, “The government of India is building a larger digital health ecosystem to help build electronic health record of citizens which is portable & universally accessible through a Health Information Exchange ensuring privacy, security & confidentiality of data.” The Health Ministry currently has three common applications in use across the country at health and wellness centres – a remarkable feat, considering the size and diversity, he said, adding the apps are for — reproductive child health (RCH), non-communicable diseases (NCD) and the third one for Tuberculosis. “Over time, we will progress towards a comprehensive primary health care application,” he said. The Union Health Minister said that other digital Health IT initiatives include an inter-operable Electronic Health Records (EHR) system, Patient Feedback System (MeraAspatal), Personal Health Record Management System (PHRMS), National Identification Number (NIN) for both public and private health facilities, which is a unique identification number for health facilities. Hospital Information System (HIS) is also being implemented for computerized registration and capturing EHR/ EMR of patients in public health facilities up to PHC level, he said. Online Registration System (ORS) is a framework to link various hospitals for online registration and appointments, online diagnostic reports and enquiring availability of blood online, he pointed out. “We are aiming at establishing an electronic database in all districts by the year 2020, to reduce the burden of paper-based data collection, recording, and storage,” he said. Nadda said the role of biotechnology in public health has been used to good effect, particularly in primary health care. “The use of point of care diagnostics, which are gradually being made available at the health and wellness centres, will enable providers to resolve more and refer less, thus improving the continuum of care, reducing patient hardship, and consequent out of pocket expenditure,” the Minister said. He said multi-sectoral action is a key to addressing social and environmental determinants and India has developed operational strategies to build a shared goal and vision between sectors such as nutrition, drinking water and sanitation, education, rural and urban development departments. ]]> https://biospectrumindia.com/news/22/11916/hrd-minister-javadekar-launches-web-portal-to-build-a-research-ecosystem.html https://biospectrumindia.com/news/22/11916/hrd-minister-javadekar-launches-web-portal-to-build-a-research-ecosystem.html Fri, 26 Oct 2018 15:55:00 +0530 Union HRD Minister Prakash Javadekar Thursday launched web portals for two schemes - IMPRESS and SPARC with an aim to build an ecosystem of research in educational institutions. "A country achieves prosperity on a sustainable basis only through innovation which can happen only by good research and which is currently a major focus area of the government," Javadekar said at a press conference here. While the objective of Impactful Policy Research in Social Sciences(IMPRESS) is to identify and fund research proposals in social sciences with maximum impact on governance and society, under IMPRESS, 1,500 research projects will be awarded for two years to support social science research in higher educational institutions. The Scheme for Promotion of Academic and Research Collaboration (SPARC) aims at building the research ecosystem of India's higher educational institutions by facilitating the Scheme for Promotion of Academic and Research Collaboration (SPARC) aims at building the research ecosystem of India's higher educational institutions by facilitating academic and research collaborations between Indian and foreign institutions.  "It is a scheme for promotion of academic and research collaboration. Under the scheme, we are giving Rs 418 crore for 600 joint research proposals. The idea is to stop brain drain and provide facilities so that they can do research in Indiin India," Javadekar said. "A set of five thrust areas (Fundamental Research, Emergent Areas of Impact, Convergence, Action-Oriented Research and Innovation-Driven) and sub-theme areas in each thrust area has been identified for collaboration under SPARC based on emergent relevance and importance for the nation," the Union minister added. IIT-Khargapur is the national coordinating institute to implement the SPARC programme. The research work under both the schemes will start from January next yeat, reported PTI.   ]]> https://biospectrumindia.com/news/22/11913/dcgi-approves-specialized-centre-for-derma-clinical-trials.html https://biospectrumindia.com/news/22/11913/dcgi-approves-specialized-centre-for-derma-clinical-trials.html Thu, 25 Oct 2018 19:20:00 +0530 In a first, the Drug Controller General of India (DCGI) have given approval to a chain of dermatology and plastic surgery centres— The Esthetic Clinics, for conducting clinical trials and drug development for skin, hair and other plastic surgery medications, cosmetology and cosmetic surgery devices in India. The initiative will help in the faster launch of newer, more innovative, cosmetic, dermatology & plastic surgery products, while reducing cost involved in product testing. It will benefit Indian pharmaceutical companies by granting them access to quality research facilities, clinicians and laboratories in India, without having to go overseas, to conduct the trials. At present, clinical trials are not mandated for every cosmetic product that enters Indian market provided it is approved in other markets. There are a few clinical trials that are conducted by clinical research organisations in India, but they do not have the clinical acumen in cosmetic, plastic or aesthetic segment. Majority of clinical trial centres work in pharmaceutical drug development, but not for cosmetic and aesthetic solutions. Dr Debraj Shome, renowned Facial Plastic surgeon & Director, The Esthetic Clinics, said, “Caring for skin and hair is a business where unmet needs still abound and people around the world are waiting for newer and better solutions. Considering India now has the clinical acumen and have the ratification of the DCGI & CDSCO to conduct clinical trials for top quality cosmetic needs, far more newer products and technology will be hitting the Indian market than before. MNCs as well as homegrown companies can easily enter the Indian market at much lower costs, keeping in mind local needs.” The DCGI under CDSCO is the supreme regulatory authority in India which gives recognition to clinical establishments, hospitals and organisations based on a set of parameters/guidelines to perform clinical research. These guidelines are aimed to protect patient rights and ensure products fulfill quality standards. Explaining the importance of conducting clinical trials in local population, Dr Rinky Kapoor, top cosmetic Dermatologist& Director, The Esthetic Clinics, said “Many products in cosmetology and aesthetics are launched in India based on clinical trials conducted overseas on Caucasians or black population and not on the Indian population. Indian skin is different and therefore it's response to medicines is different. Hence, it becomes important to do clinical trials in our particular population where the product is going to be launched, instead of performing the same in a completely diverse population.” The Esthetic Clinics have been at the helm of clinical research for close to a decade. The institute has made outstanding contributions in the field of facial plastic surgery, cosmetic surgery, plastic and reconstructive surgery, cosmetic dermatology, skin care and aesthetic medicine. It practices evidence-based medicine, is at the forefront of cutting edge global clinical research and has to their credit over 60 national and international peer-reviewed publications and two global patents for their research around eye cancer & for the invention of a revolutionary hair regrowth composition called the QR 678 growth factor injection. The organisation has around nine centres across India with 6 centres in Mumbai and one each in Hyderabad, Kolkata, Surat and Delhi. The global hair formulation market is valued at $ 7 billion while the skin care industry is estimated to be $ 50 billion. The key growth drivers for the industry are changing consumer lifestyle, increasing awareness on aesthetic beauty and rising disposable income. Multinational players with international brands have a strong presence in the Indian formulation segment.   ]]> https://biospectrumindia.com/news/22/11906/cci-brings-out-policy-note-on-affordable-healthcare.html https://biospectrumindia.com/news/22/11906/cci-brings-out-policy-note-on-affordable-healthcare.html Wed, 24 Oct 2018 22:50:00 +0530 Over the nine years of enforcement of the Competition Act, 2002 (the Act), the Competition Commission of India (‘the Commission’) has received 52 cases pertaining to the pharmaceutical and healthcare sector. The Commission, while deciding on the cases, has observed that information asymmetry in the pharmaceutical/healthcare sector significantly restricts consumer choice. In the absence of consumer sovereignty, various industry practices flourish which have the effect of choking competition and are detrimental to consumer interest. Such practices may not always violate the provisions of the Act, but they create conditions that do not allow markets to work effectively and healthy competition to drive the market outcomes. The response to these issues can, in many instances, take the form of appropriate regulations that can pre-empt market-distorting practices and help create pro-competition conditions. As the competition authority of the country, the Commission felt the need for close examination and focused deliberations on these issues, which have implications for markets and competition in this sector of critical importance. In pursuance of the same, a series of initiatives has been taken up by the Commission over the years in the pharmaceutical and healthcare sector, which culminated in a Technical Workshop on ‘Competition Issues in the Healthcare and Pharmaceutical Sector in India’ organised on August 28-29, 2018 in New Delhi with representatives of all stakeholder groups, including pharmaceutical industry, healthcare service providers, civil society organisations, regulators, healthcare think tanks. The issues identified and recommendations suggested by the stakeholders have been documented in a Policy Note by the Commission titled ‘Making Markets Work for Affordable Healthcare’. The key issues and recommendations are as under:   Role of intermediaries in drug price build-up   One major factor that contributes to high drug prices in India is the unreasonably high trade margins. The high margins are a form of incentive and an indirect marketing tool employed by drug companies. Further, self-regulation by trade associations also contributes towards high margins as these associations control the entire drug distribution system in a manner that reduces competition. Efficient and wider public procurement and distribution of essential drugs can circumvent the challenges arising from the distribution chain, supplant sub-optimal regulatory instruments such as price control and allow for access to essential medicines at lower prices. Electronic trading of drugs, with appropriate regulatory safeguards, could be another potent instrument for bringing in transparency and spurring price competition among platforms and among retailers, as has been witnessed in other product segments.   Quality perception behind proliferation of branded generics   Worldwide, generic drugs are seen as a key competitive force against the patent-expired brand name drugs marketed at monopoly prices. In India, the pharmaceutical market is dominated by ‘branded generics’ which limit generic-induced price competition. The branded generic drugs enjoy a price premium owing to perceived quality assurance that comes with the brand name. Quality consideration may be a reason behind the prescription of branded generics by doctors. However, it is also equally possible that the brand proliferation is to introduce artificial product differentiation in the market, offering no therapeutic difference but allowing firms to extract rents. The regulatory apparatus must address the issue of quality perception by ensuring consistent application of statutory quality control measures and better regulatory compliance. Unless the quality of drugs sold in markets can be taken to be in conformance of the statutory standards regardless of their brand names, generic competition in the true sense of the term cannot take off. The practice of creating artificial product differentiation for exploitation of consumers may be addressed through a one-company-one drug-one brand name-one price policy.   Vertical arrangements in healthcare services   In view of the incentive-based referral system that pervades the healthcare landscape, issuing of periodic validated data by hospitals relating to mortality rate, infection rate, number of procedures etc. could help patients make informed choice. The in-house pharmacies of super specialty hospitals are completely insulated from competition as inpatients are typically not allowed to purchase any product from outside pharmacies. This calls for regulation that mandates hospitals to allow consumers to buy standardised consumables from the open market. All accredited diagnostic labs should meet the same quality standards in terms of infrastructure, equipment, skilled manpower etc. for getting accreditation. This will ensure the same degree of reliability and accuracy of test results across labs. There is no regulatory framework that ensures and governs portability of patient data, treatment record, diagnostic reports between hospitals. This acts as a constraint for patients in switching from one hospital to another and creates a lock-in effect. Portability of patient data can help ensure that a patient is no longer locked into the data silos and do not bear additional cost for switching medical services and that doctors/hospitals can have timely access to patient data.   Regulation and competition   Owing to the multiplicity of regulators governing the pharmaceutical sector at the centre and state level, implementation of regulations is not uniform across the country. This has resulted in multiple standards of same products and also different levels of regulatory compliance requirements. A mechanism may be devised under the aegis of the CDSCO to harmonise the criteria/processes followed by the state licensing authorities to ensure uniformity in interpretation and implementation. It is also imperative to make the approval of new drugs time-bound along with publication of detailed guidelines governing each stage of new drug approval process.             Finally, two other major issues that affect the healthcare sector and thus warrant policy response are: (i) shortage of healthcare professionals in the country owing inter alia to high cost of medical education and (ii) inadequacy in health insurance. Public health delivery is a complicated policy matter. The focus of the Policy Note does not lose sight of legitimate public policy objectives, but endeavours to determine the extent to which choice and competition can improve outcomes consistent with those objectives. Accordingly, the Policy Note is being shared with Ministry of Corporate Affairs, Ministry of Health and Family Welfare, Department of Pharmaceuticals and NITI Aayog. The Commission will continue to enforce antitrust rules in the pharmaceutical and healthcare sector to ensure that effective competition is not undermined in these markets. However, since enforcement cannot address all competition issues in the sector, the instrument of competition advocacy is employed with more vigour to facilitate discussions and make policy changes that are necessary to address the conditions triggering non-competitive market outcomes. ]]> https://biospectrumindia.com/news/22/11867/niti-aayog-to-launch-guidelines-for-ppp-in-ncds-treatment.html https://biospectrumindia.com/news/22/11867/niti-aayog-to-launch-guidelines-for-ppp-in-ncds-treatment.html Wed, 17 Oct 2018 11:10:00 +0530 The contribution of non-communicable diseases (NCD) to the overall disease burden in the country has increased over the years. In the past many district hospitals in the country have focused mainly on communicable diseases and reproductive and child health. As a result of which the capacity for handling NCD cases has not been adequately developed. The NITI Aayog and MoHFW has worked with State Govts. and representatives from the healthcare industry to develop the Model Concessionaire Agreements (MCA) to supplement efforts for the provision of prevention and treatment services for non-communicable diseases (Cardiac Sciences, Oncology, and Pulmonary Sciences) at the district hospital particularly especially in tier 2 & 3 cities. The Guidelines and the MCA will be announced by Dr VK Paul, Member, NITI Aayog, Shri Amitabh Kant, CEO, NITI Aayog and Smt Preeti Sudan, Secretary, Ministry of Health and Family Welfare. ]]> https://biospectrumindia.com/news/22/11833/dcgi-approves-brintellix-for-major-depressive-disorder.html https://biospectrumindia.com/news/22/11833/dcgi-approves-brintellix-for-major-depressive-disorder.html Thu, 11 Oct 2018 16:30:00 +0530 Lundbeck India Private Limited (LIPL) has announced the launch of Brintellix (Vortioxetine) in India for the treatment of patients suffering from Major Depressive Disorder (MDD) after receiving approval from Drug Controller General of India (DCGI). As per a large-scale survey conducted by NIMHANS, an estimated 1 in 20 people in India suffers from depression. Mental disorders such as Major Depressive Disorder or depression in simple words affects everyone, irrespective of age, gender and living standards but research has shown that some segments of population seem to be at a higher risk of suffering from depression especially women and urban dwellers. There could be several factors like fast paced lifestyle, stress, complexities of living, breakdown of support systems, challenges of economic instability for this higher prevalence in urban population. Brintellix, is a novel multimodal antidepressant, which has been specifically designed to inhibit serotonin reuptake and modulate serotonergic receptor activity of the neurons in the brain of affected patients. It has demonstrated significant efficacy in reducing the mood symptoms in adult patients with depression as measured by traditional scales like MADRS or HAMD. It has also demonstrated improvement of cognitive performance in adult patients with depression, as measured with neuropsychological tests, as e.g. DSST or RAVLT. Cognitive symptoms are part of the diagnostic criteria for depression, and include the ability to concentrate, make decisions and the ability to remember. Cognitive symptoms are both part of the acute depressive episode as well as often being a residual symptom of depression. This means that patients with depression may have difficulties performing their duties at work which leads loss of productivity and it impacts the person, his family and the society. “When someone suffers from depression, the daily life of that person is severely affected, at home and in the workplace. Depression is a complex disease that involves mood, physical and cognitive symptoms. We are pleased to be able to offer a new treatment option to the patients with depression which can address all the symptoms of depression, helping the patient to function better,” says Maninder Singh Sahwney, Country Manager at Lundbeck India. ]]> https://biospectrumindia.com/news/22/11822/india-to-achieve-all-public-health-goals-j-p-nadda.html https://biospectrumindia.com/news/22/11822/india-to-achieve-all-public-health-goals-j-p-nadda.html Wed, 10 Oct 2018 12:00:00 +0530 “India is deeply committed nationally and globally to achieving all public health goals. Together we are working towards providing highest possible standards of health care for our citizens. Universal health coverage is key to the Sustainable Development Goals 2030 agenda and to which India is firmly committed.” This was stated by J P Nadda, Union Minister of Health and Family Welfare during his address at the inauguration of ‘2nd World Conference on Access to Medical Products: Achieving the SDGs 2030’, at New Delhi recently. At the function, J P Nadda released the Position Paper and launched the Information Sharing Platform Gateway for South-East Asia Regulatory Network (SEARN) developed by Centre for Development of Advanced Computing, which will promote regulatory and health collaboration among the countries of the South-East Asia Region. Ashwini Kumar Chaubey, Minister of State (HFW), Anupriya Patel, Minister of State (HFW), Preeti Sudan, Secretary (Health), Balram Bhargava, Secretary, Dept. of Health & Research (DHR) and DG, ICMR, Dr Mariângela Batista GalvãoSimão, Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals, WHO Geneva, Dr. Poonam Khetrapal Singh, Regional Director, WHO SEARO, Dr RK Vats, Additional Secretary, Health Ministry, and Dr.HenkBekedam, WHO Representative to India, also graced the occasion. State Health Ministers and Principal Secretaries from several states in India were also present. Speaking at the function, Nadda said that the National Health Policy 2017 is dedicated to the highest possible standards of health for the country. “The Government has launched Ayushman Bharat, a National Health Protection Scheme, which envisions health assurance of 5 lakh rupees ($6815) per family per year, will benefit over 50 crore (i.e. 500 million) people, and is the world's biggest health assurance scheme”. He further added that since its launch on 23rd September, 2018, more than 50,000 people have availed of services under the scheme. The Union Health Minister stated that access to medical products and creating an enabling legal and trade environment for public health are critical to achieving the Sustainable Development Goals 2030 Agenda. “These issues require continuous engagement and dialogue.  I believe that the Health Ministry with active partnership of other ministries in Government of India will move forward in leaps and bounds,” he said.  The Union Health Minister further added that India is actively contributing and providing support for the South-East Asia Regulatory Network (SEARN) to guarantee access to high-quality medical products. ]]> https://biospectrumindia.com/news/22/11791/government-to-ensure-safety-of-vaccines.html https://biospectrumindia.com/news/22/11791/government-to-ensure-safety-of-vaccines.html Thu, 04 Oct 2018 10:55:00 +0530 There have been reports that bivalent oral polio vaccine supplied by Ghaziabad based Biomed Pvt Ltd had some quality issues.  As the vaccine is part of the government’s universal immunisation programme, the ministry has issued directions for the immediate withdrawal of this particular manufacturer’s vaccine. It may be remembered that the decision to switch to inactivated poliovirus vaccine (IPV) and bivalent Oral Polio Vaccine (bOPV) from trivalent Oral Polio Vaccine (tOPV) in all polio campaigns and routine immunization in India and elsewhere from April 2016 was taken following certification of global eradication of type 2 wild poliovirus. In India, the last Type 2 wild polio virus case was detected in the year 1999. The tOPV that was used till April 2016 contained three types of poliovirus vaccines (P1, P2 and P3) and protected against all three types of wild polioviruses – type 1, type 2 and type 3, while bOPV contains two types of poliovirus vaccines (P1 and P3) and protects against type 1 and type 3 wild polioviruses. Type 2 component from oral polio vaccine was removed as a part of global polio end game strategy. Recently, type 2 polio vaccine virus was found in some sewage and stool samples. The detection of type 2 vaccine virus indicates that a very robust polio surveillance jointly managed by MoHFW and WHO is still maintained even after 7 years have elapsed since last wild poliovirus case in the country was reported. This detection indicated the use of a type 2 poliovirus containing vaccine, despite the fact that tOPV that contained type 2 poliovirus vaccine had been phased out globally, and in India, in April 2016, as a part of the Polio End Game strategy. On investigation, it was found that in a few vials of bOPV supplied by Biomed, there were traces of P2 vaccine. The Ministry of Health and Family Welfare taking WHO on board took immediate and comprehensive action. Following the report, the use of all the vaccine supplied by this manufacturer was immediately stopped in the country till investigation was completed. Additional legal samples of bOPV were immediately sent for testing to the Central Drug Laboratory in Kasauli, which confirmed the previous report of presence of traces of P2 polio vaccine virus. The Drugs Controller General of India immediately filed an FIR and issued notice to the company asking it to stop manufacturing and supplying till further orders. The MD of the company was immediately arrested. Type 2 polio vaccine virus traces which have been found in bOPV vials is the attenuated (weakened) poliovirus and does not cause paralysis and was also earlier used in tOPV till April 2016. The recipients of such vaccine will usually shed the vaccine virus through fecal route for about 4-6 weeks after which it will die down.   In small areas where such vials were used, polio surveillance in environment and through stool collection has been significantly enhanced by MoHFW, with support from WHO and partners to keep constant vigil on the shedding of the polio vaccine virus. To enhance immunity against type 2 poliovirus further, special mop up rounds for administering IPV are being conducted in the specified areas to reach out to such children who may have missed IPV. This would provide immunity to all the children against all the three types of polio virus including Type 2. In view of high routine immunization coverage being achieved in India and administration of tOPV till 2016, our population level immunity against all three types of virus is very high. This fact was acknowledged and appreciated in recently conducted India Expert Advisory Group on Polio which comprises of international and national experts. India has also made remarkable progress under Swachh Bharat Abhiyaan In light of all the above facts and measures taken, the risk of any child getting vaccine derived polio disease is practically nil. Sufficient polio vaccine from alternate sources is available in the programme to implement Routine Immunization (RI) and Pulse Polio Immunization (PPI) and maintain the immunity against polio-viruses. No sample has tested positive for wild poliovirus in sewage or AFP cases since 2011. The country remains polio-free and this status has been maintained for more than seven years since the last wild poliovirus case in the country was reported in January 2011. No child has been infected with wild poliovirus as reported in some sections of the media. A team of MoHFW, DCGI, ICMR and WHO is continuously monitoring the situation. Government of India is committed as always to ensure that all vaccines used in the programme are safe and effective.   ]]> https://biospectrumindia.com/news/22/11770/healthcare-experts-to-use-blockchain-for-real-drug-supply.html https://biospectrumindia.com/news/22/11770/healthcare-experts-to-use-blockchain-for-real-drug-supply.html Mon, 01 Oct 2018 09:50:00 +0530 NITI Aayog has teamed up with Oracle, Apollo Hospitals and Strides Pharma to track drug supply chain using blockchain and IoT solutions. This will be a pilot project for three months. Oracle’s blockchain software permanently registers a drug’s record in the manufacturer’s drug supply chain (serial number, labelling, scanning), leaving no scope for record tampering. From here on, at every point of hand change, it records the drug’s movement – from manufacturer to logistics, from stockist to hospital, or from pharmacy to consumer. In case of a fake drug, the software will detect irregularity and notify the concerned nodal point. Besides, Oracle IoT will provide options to track critical information such as chemical ingredients of the drug or maintenance of temperature control in case of life saving drugs or vaccines. According to Amitabh Kant, CEO, NITI Aayog, “the problem of fake and counterfeit drugs is a major issue, costing the Indian pharma industry billions. At the same time, it’s putting patients at higher risk. This agreement with Oracle and our partnership with Apollo Hospitals and Strides Pharma, will help ensure that Indian drug manufacturers and healthcare experts have access to a standards-based, modern technology platform – blockchain and IoT, to help eliminate fake drug distribution.” ]]> https://biospectrumindia.com/news/22/11758/cabinet-approves-mou-with-uzbekistan-for-pharma-health-sector.html https://biospectrumindia.com/news/22/11758/cabinet-approves-mou-with-uzbekistan-for-pharma-health-sector.html Thu, 27 Sep 2018 11:00:00 +0530 The Union Cabinet chaired by Prime Minister Narendra Modi has approved the signing of a Memorandum of Understanding (MoU) between India and Uzbekistan for increased cooperation in the areas of Trade, Industry, and Research & Development of Pharmaceutical products, and health and medical science. The MoU for the pharma sector will explore the possibilities for the production of medicines, including Active Pharmaceutical Ingredients (APIs) in different therapeutic segments in both countries. It will also exchange information on trade and registration   procedures, legal   and   regulatory   requirements   for export and import of pharmaceuticals products, including APIs. The agreement for health sector includes expanding opportunities for the development of business cooperation in the field of medical equipment, for teaching and research laboratories of institutions of medical education, and pharmaceutical products. It also includes strengthening of primary health care and setting up of health care facilities; medical and health research development, as well as exchange of experience in these areas; exchange of experiences and technologies in the field of telemedicine and electronic-health information systems, maternal and child health protection; development and improvement of the techniques and strategies for epidemiological surveillance and communicable and non-communicable diseases control, regulation of drugs and pharmaceutical products. ]]> https://biospectrumindia.com/news/22/11744/arunachal-cm-launches-universal-healthcare-scheme.html https://biospectrumindia.com/news/22/11744/arunachal-cm-launches-universal-healthcare-scheme.html Tue, 25 Sep 2018 16:05:00 +0530 Arunachal Pradesh Chief Minister Pema Khandu on Sunday dedicated the Chief Minister Aarogya Arunachal Yojana (CMAAY), a universal healthcare scheme of the state government, to the people of the state. The launching of the health insurance scheme in this frontier state coincided with the nationwide launch of 'Ayushman Bharat - Pradhan Mantri Jan Aarogya Yojana' by Prime Minister Narendra Modi. Khandu said that the state's healthcare scheme will be dovetailed with the centre's PMJAY scheme with Rs 50 crore earmarked to provide cashless treatment of Rs 5 lakh per family per year. He said the state's healthcare scheme will provide coverage to those beneficiaries left out in the PMJAY scheme. About 88,928 families as per 2011 Socio Economic Caste Census (SECC) in Arunachal are eligible for PMJAY scheme out of 3.05 lakhs families.   ]]> https://biospectrumindia.com/news/22/11736/industry-reacts-on-ayushman-bharat-pmjay.html https://biospectrumindia.com/news/22/11736/industry-reacts-on-ayushman-bharat-pmjay.html Mon, 24 Sep 2018 12:45:00 +0530 After the launch of Ayushman Bharat Pradhan Mantri Jan Aarogya Yojana (ABPMJAY) by Prime Minister Narendra Modi, BioSpectrum presents reactions of some industry professionals on the same: “The PMJAY is clearly a massive leap towards universal health coverage that could transform the healthcare landscape in India. We believe that digital infrastructure will be key to a seamless and transparent system of transacting the costs of drugs, diagnostics and therapeutic interventions. We are keenly monitoring the operating models to be followed by empanelled hospitals and will continue to serve communities with the highest quality of care and commitment possible. We are happy to state that with the launch of Jan Arogya Yojna, Paras Healthcare has also become the part of the Prime Minister,s vision of making India Healthier,” said Dr Dharminder Nagar, MD, Paras Healthcare. "The announcement of Jan Arogya Abhiyan is a landmark scheme and a much needed boost to India's healthcare system. Till now at least 27% people around the poverty line who could not have afforded healthcare would hit by the high cost of treatment.  With a promise of a transparent, IT-enabled system, the initiative promises to benefit 50 crore plus population is indeed laudable. Another aspect that stands out is the integration of the wellness centers, the first pillar, with Ayushman Bharat, the second pillar government healthcare delivery. As a provider of healthcare delivery at a village level through an IT enabled health card system, which includes access to secondary care and tertiary care with a network of  service providers , it is interesting for us to note  that how close and complimentary Jan  Arogya Abhiyan and Gramin Health Care is to each other. Both our models drive cot effective and scalable institutional by providing volumes to private healthcare enterprises and at the same time benefit the masses with affordable healthcare. While our system is supported by private organizations, the Jan Arogya initiative will be funded 60% by the central government. Till now individual private hospitals are becoming a part of the Prime  Minister's initiative,  as the initiative stabilizes after launch, we expect the growing world of Gramin Health Care will be recognized as an important partner to Government's Ayushman Bharat Initiative,” said Ajoy Khandheria, Founder, Gramin Healthcare. “Ayushman Bharat is a very ambitious scheme and would be the largest State sponsored scheme in the world. The success of this scheme would depend upon the effective implementation of this scheme. This scheme would definitely increase awareness among the population and help set in some standards of care especially in rural areas,” said Mr. Shreeraj Deshpande, Head-Health Insurance, Future Generali India Insurance on the Ayushman Bharat launch. ]]> https://biospectrumindia.com/news/22/11732/accord-healthcare-recalls-diuretics-due-to-labelling-mix-up.html https://biospectrumindia.com/news/22/11732/accord-healthcare-recalls-diuretics-due-to-labelling-mix-up.html Mon, 24 Sep 2018 11:25:00 +0530 Accord Healthcare Inc, the US arm of Intas Pharmaceuticals, is recalling over 46,000 bottles of Hydrochlorothiazide tablets manufactured by the Ahmedabad-based firm, on account of labelling mix-up, USFDA said. Hydrochlorothiazide tablets belong to a class of drugs known as diuretics and are used for treatment of high blood pressure and edema. Accord Healthcare is recalling 46,632 bottles of Hydrochlorothiazide tablets USP in the strength of 12.5 mg, the Enforcement Report by United States Food and Drug Administration (USFDA) said. The reason for the recall is "Labelling: label mix-up: customer complaint that a sealed bottle labelled as Hydrochlorothiazide tablets USP 12.5 mg contained only Spironolactone tablets USP 25 mg," it added. The voluntary nationwide recall in the US and Puerto Rico has not been classified yet, the report said. ]]> https://biospectrumindia.com/news/22/11730/pm-launches-ayushman-bharat-pmjay-at-ranchi.html https://biospectrumindia.com/news/22/11730/pm-launches-ayushman-bharat-pmjay-at-ranchi.html Mon, 24 Sep 2018 11:05:00 +0530 The Prime Minister, Narendra Modi, has launched the health assurance scheme: Ayushman Bharat - Pradhan Mantri Jan ArogyaYojana at Ranchi, Jharkhand. The Prime Minister visited an exhibition on the scheme, before arriving on the dais to launch PMJAY at a huge public gathering. At the same event, the Prime Minister unveiled plaques to lay the Foundation Stone for medical colleges at Chaibasa and Koderma. He also inaugurated 10 Health and Wellness Centres. Speaking on the occasion, the Prime Minister said that this launch has been done with a vision to provide the poorest of the poor, and the underprivileged sections of society, with better healthcare and treatment. He said this scheme, which envisions health assurance of 5 lakh rupees per family per year, will benefit over 50 crore people, and is the world's biggest health assurance scheme. He said the number of beneficiaries of this scheme is roughly equal to the population of the European Union, or the population of America, Canada and Mexico, taken together. He said the first part of Ayushman Bharat - the health and wellness centres, was launched on BabasahebAmbedkar's birth anniversary, and the second part - the health assurance scheme, is being launched two days before Deendayal Upadhyay's birth anniversary. Explaining how comprehensive the PMJAY is, the Prime Minister said it would cover 1300 illnesses, including serious illnesses such as cancer and heart disease. He said private hospitals too would be part of this scheme. The Prime Minister said that the amount of 5 lakhs would cover all investigations, medicine, pre-hospitalization expenses etc. He said it would also cover pre-existing illnesses. He said that people can learn more about the scheme by dialling 14555, or through their Common Service Centre. The Prime Minister said that for the States that are a part of PMJAY, people can get the benefit of the scheme in whichever of these States they go to. He said more than 13,000 hospitals across the country have joined the scheme so far. The Prime Minister also spoke of the 10 health and wellness centres inaugurated today. He said the number of such centres across the country has reached 2300. He said the aim is to have 1.5 lakh such centres in India within four years. The Prime Minister said that the Union Government is working with a holistic approach to improve the health sector in the country. He said the focus is on both "Affordable Healthcare" and "Preventive Healthcare." The Prime Minister expressed confidence that through the efforts of all those involved with PMJAY, and the dedication of the doctors, nurses, healthcare providers, ASHAs, ANMs etc, the scheme would become a success. ]]> https://biospectrumindia.com/news/22/11727/medtech-industry-comes-together-to-partner-ayushman-bharat-scheme.html https://biospectrumindia.com/news/22/11727/medtech-industry-comes-together-to-partner-ayushman-bharat-scheme.html Fri, 21 Sep 2018 15:30:00 +0530 Leading industry bodies representing medical technology sector recently came together at MTaI MedTekon 2018 to discuss ways to strengthen healthcare delivery under Ayushman Bharat scheme, a government programme to enable the bottom 40% of India’s population access healthcare for free. Representatives of Medical Technology Association of India (MTaI), Advance Medical Technology Association (AdvaMed), AmCham Medical Devices Committee, Confederation of Indian Industries (CII), Healthcare Federation of India (NATHEALTH) and Federation of Indian Chambers of Commerce and Industries (FICCI), underscoring their solidarity, huddled up with government officials, doctors, investors and patients’ groups to chalk out a roadmap for the industry to contribute effectively to the world’s largest healthcare reform programme. Starting 25th September 2018, the government plans to provide health insurance to 10 crore families and also strengthen the network of primary health centers in the country. Most secondary and tertiary treatments will be covered under the scheme. As per statistics, health insurance has spread only to 27% of the population-the cover being sparse-and more than 80% of healthcare expenditure is incurred by individuals from their own pockets. “We admire the vision of inclusion behind Ayushman Bharat and the programme’s massive scale. It has the ability to stimulate the economy due to its impact on the health of the labor force as well as provide a new ecosystem in healthcare business which can sprout a thousand new ladders of commercial success.” MTaI Chairman Pavan Choudary said. For the scheme, the government has recommended maximum allowable costing for 1363 health procedures.  Probir Das, Senior Vice President, Healthcare Federation of India (NATHEALTH), said: “The cost structure still needs work. While for many procedures the cost may be optimum, for several, it may require a re-think. The ideal way to resolve this problem will be to keep the cost of medical devices outside the procedure costs. Also, given the fact that international MedTech companies use their global network to train physicians and develop modern therapies in India, they should be considered as a vital pillar for consultation and programme development”. Badhri Iyengar, Chairman of FICCI’s Medical Devices & Equipment Committee, said: “Medical devices and diagnostic services are very important in health treatments. By the virtue of this, we feel that the medical technology industry is an important stakeholder for Ayushman Bharat. We are committed to contributing in letter and spirit to the successful implementation of the pathbreaking scheme. Today’s deliberations have been important in paving the way for this”. Madan Krishnan, Chairman, AdvaMed, said “the next stage of today’s constructive dialogue is industry-government dialogue to enhance impact and success of the programme. MedTech industry can actively partner with the government and providers to transform healthcare in India by structuring effective patient care pathways along with outcome based models.”  Diwaker Rana, Co-Chairman MTaI Medtekon said: “A comprehensive view of the healthcare industry should be taken to make it rewarding for all stakeholders. This will poise it for success.” “The Ayushman Bharat Scheme will significantly bring down the out of pocket healthcare expenses and have an indirect impact on individual wealth which will lead to economic growth of the nation. The other longer term and most important impact of the scheme will be the data repository through AB-NHPM, it will facilitate research and evidence-based decision making in future.” added Himanshu Baid, Chairman of Medical technology Division, CII. The summit was inaugurated by Dr. Vinod K. Paul, Member, NITI Aayog. In his speech, Dr. Paul said “Ayushman Bharat is based on three pillars: Primary Health, Diagnosis and Health Insurance. The scheme at present takes care of lowest two quintiles of our population. It is an integrated healthcare scheme where we have integrated the public and private sectors and given patients the power to decide where they want to access the healthcare services from. To me, it is an anti-poverty measure which prevents people from falling into poverty due to healthcare requirements. I believe if we save a healthy life for a year, we can add 1.5% to the GDP.” Dr. Paul urged the international fraternity to suggest how they can contribute to Ayushman Bharat scheme. “The international fraternity can help us strengthen the scheme going forward. They have a strong R&D, can bring investments for Make in India, set up health and wellness centres through their CSR centers and train healthcare professionals. I would like to ask the fraternity to come up with ideas on how they can contribute to the scheme,” he added. During the summit, MTaI unveiled a theme paper entitled ‘MedTech – The Keystone for Ayushman Bharat’. The paper presents Ayushman Bharat scheme in summary and points out the concerns of stakeholders which need to be dovetailed to ensure success. The theme paper also brings out the possible solution to these concerns. “For the success of the Ayushman Bharat programme, it will require the coordinated action of all stakeholders in the complex healthcare industry including health insurers and TPAs, providers, the pharmaceutical industry, the medical device & diagnostic industry Ayushman Bharat has the potential to transform the perception of the Indian public towards government healthcare schemes. It will be no small feat to achieve the core objectives that it has set for itself and if the scheme is implemented in a methodical, systematic and well researched manner, the Healthcare landscape shall truly be transformed.” the paper states. ]]> https://biospectrumindia.com/news/22/11726/over-15000-hospitals-ready-to-be-empanelled-for-mega-healthcare-scheme.html https://biospectrumindia.com/news/22/11726/over-15000-hospitals-ready-to-be-empanelled-for-mega-healthcare-scheme.html Fri, 21 Sep 2018 15:00:00 +0530 As many as 27 states and Union Territories are ready to join the ambitious healthcare scheme Pradhan Mantri Jan Arogya Yojana after its launch on Sunday by Prime Minister Narendra Modi, a Niti Aayog member said. Over 15,000 hospitals, both public and private, across the country have expressed their willingness to be empanelled for the scheme which aims to provide 107.4-million poor families health insurance, Niti Aayog member V K Paul, who is the chief architect of the scheme, told PTI in an interview. "The Prime Minister will launch the scheme on September 23 but effectively it will become operational from September 25 on the birth anniversary of Pandit Deendayal Upadhyay," he said, adding that in the current fiscal, the burden on the Centre is likely to be around Rs 3,500 crore. "With the launch by the prime minister, 26-27 states and UTs are likely to immediately commence the PMJAY," Paul added. The Niti Aayog member said that five or six states have not signed, so obviously the scheme will not be implemented in those states till they come on board. "Remaining states that have signed (MoUs with the Centre) should hopefully be in the process of actual launch of (PMJAY) in the next 2-3 months," he noted. Paul also said that the government expects thousands of new hospitals to come up in the next five years in tier 2 and tier 3 cities. "We have received applications from 15,000 hospitals for being empanelled. Out of this half, that means 7,500 applications for empanelment are private hospitals," he said, adding that in some states process for empanelment is yet to start. ]]> https://biospectrumindia.com/news/22/11723/indian-medical-devices-may-get-indian-standardization-.html https://biospectrumindia.com/news/22/11723/indian-medical-devices-may-get-indian-standardization-.html Fri, 21 Sep 2018 12:55:00 +0530 A range of medical devices, old or new, will soon have an 'Indian standard' and nearly 1,000 products are presently being benchmarked. NITI Aayog member V K Paul, in his address at a conference MedTekon 2018, said the standardisation is expected to be completed in the next two months.  "We don't have any Indian standards (for medical devices). As we speak, about 1,000 products' standards are being completed, and the deadline for that is about two months from now.  "And, from old devices to new, most of the important devices will carry Indian standardisation from the BIS," he said.  The Bureau of Indian Standards (BIS) is the national standards body of India working under the aegis of the Ministry of Consumer Affairs, Food & Public Distribution.  The conference MedTekon 2018 -- MedTech Vitalising Ayushman Bharat, organised by Medical Technological Association of India (MTaI) was also attended by Swedish envoy Klas Molin. Molin said Sweden, both at government and company-level, would like to engage with India when it comes to health and life sciences.  Paul, a key architect of the Centre's flagship health scheme Ayushman Bharat, also urged Sweden to partner with the country in this mission and asked the private medical technology companies of India to be "catalyst of change" in this "revolution waiting to happen".  The 'Ayushman Bharat' scheme aims to holistically address health (covering prevention, promotion and ambulatory care) at primary, secondary and tertiary levels.  MTaI welcomed the move by the government to bring Indian standardisation, but cautioned that it should not "dilute the existing" global standards that companies adhere to.  MTaI Chairman Pavan Choudhary and other members said that several Indian med-tech firms are already following global best standards.  "The new standards would help bring into those players who do not confirm to such standards. But, the Indian standards, once they are brought in, will need a lot of harmonising with the existing global norms," said Probir Das, director of MTaI.  ]]> https://biospectrumindia.com/news/22/11718/health-ministry-collaborates-with-tata-trusts-dell.html https://biospectrumindia.com/news/22/11718/health-ministry-collaborates-with-tata-trusts-dell.html Fri, 21 Sep 2018 10:35:00 +0530 Ministry of Health and Family Welfare has recently exchanged MoUs with the Tata Trusts and Dell to provide a technological platform for nationwide prevention, control, screening and management programme of Non Communicable Diseases (NCDs). Anupriya Patel, Minister of State for Health and Family Welfare presided over the ceremony and also released the user manual for NCD application under Comprehensive Primary Health Care (CPHC) IT Solutions. Preeti Sudan, Secretary (Health) , Burzis Taraporewala, Senior Adviser, Tata Trusts and Sarv Saravanan, Senior Vice President, Dell EMC COE and Jeremy Ford, Director, Dell Giving were also present at the MoU exchange ceremony. The NCD screening program addresses Hypertension, Diabetes, Oral, Breast and Cervical cancers and covers all men and women over the age of 30 years. The programme, which is one of the modules in Ayushman Bharat’s Comprehensive Primary Healthcare (CPHC) Initiative, is currently being deployed in about 200 districts across the country. Through implementation of the software, it will also be possible to track health trends across the country. Aimed at bringing healthcare technology transformation in Comprehensive Primary Health Care NCD program under Ayushman Bharat, the Health Ministry is working with Dell as technology partner and the Tata Trusts as deployment partner. A cloud-based mobile, web and analytics solution has been developed to digitize health records to aid the population-based screening program, to bring quality health services at door step, to enable increased productivity for health workers and doctors, and to facilitate monitoring of delivery of services by state and district administrators. ]]> https://biospectrumindia.com/news/22/11714/government-begins-publicity-drive-for-ayushman-bharat-.html https://biospectrumindia.com/news/22/11714/government-begins-publicity-drive-for-ayushman-bharat-.html Thu, 20 Sep 2018 14:45:00 +0530 Four days ahead of the country-wide roll-out of Prime Minister Narendra Modi’s Ayushman Bharat healthcare scheme, the Centre has started its outreach programme. Centre is going on a publicity overdrive to create awareness for the PM Jan Arogya Yojana, also asking states to ensure patients are informed of the scheme once they reach the hospital for treatment starting this Sunday. Orders have been issued to the states to start informing people visiting hospitals about the scheme to create awareness about what it offers. Modi is set to launch the scheme in Ranchi on 23 September. Earlier, the government had planned to launch the scheme on 25   September, the birth anniversary of the Pandit Deen Dayal Upadhyaya. The healthcare scheme, being touted as the world’s largest, aims to cover over 10 crore families (50 crore beneficiaries) and provide health cover up to Rs 5 lakh per family per year. ]]> https://biospectrumindia.com/news/22/11671/government-bans-328-combination-drugs.html https://biospectrumindia.com/news/22/11671/government-bans-328-combination-drugs.html Fri, 14 Sep 2018 11:35:00 +0530 The central government has banned 328 combination drugs leading to a blow for both domestic and foreign pharmaceutical firms. At the same time, the ban has been cheered by health activists worried about growing antibiotic resistance due to the misuse of medicines. The board has found that there was no therapeutic justification for the ingredients contained in 328 fixed-dose combinations (FDCs) and these FDCs may involve risk to human beings. In 2016, the government had banned about 350 such FDCs, but the industry mounted various legal challenges that prompted the Supreme Court to call for a review by an advisory board. According to the president of the Indian Drug Manufacturers’ Association, Deepnath Roychowdhury, the order would have an impact on a market worth an estimated 16 billion rupees a year for such drugs, which are produced by both small and large pharmaceutical companies. ]]> https://biospectrumindia.com/news/22/11661/tn-inks-mou-to-implement-health-scheme.html https://biospectrumindia.com/news/22/11661/tn-inks-mou-to-implement-health-scheme.html Wed, 12 Sep 2018 10:25:00 +0530 The Tamil Nadu (TN) government has signed a Memorandum of Understanding (MoU) with the Central government to implement Ayushman Bharat Yojana in association with state-run Chief Minister's Comprehensive Health Insurance Scheme (CMCHIS). The implementation of the National Health Protection Scheme in association with the state insurance scheme will benefit about 77 lakh poor and vulnerable families in Tamil Nadu. Tamil Nadu's health insurance scheme covers 1.57 crore families and provides coverage of Rs 1 lakh per year for 1,027 procedures, and Rs 2 lakh per year for 154 specified medical procedures. The state also has a corpus for treatment of eight high-end procedures. All high-end procedures like cochlear implant, liver transplant, bone marrow and stem cell transplant, renal transplant, heart and lung transplant, auditory brainstem implant up to Rs 25 lakh covered by the corpus set up under the state-run insurance scheme will continue. ]]> https://biospectrumindia.com/news/22/11636/health-ministry-to-rename-cdsco.html https://biospectrumindia.com/news/22/11636/health-ministry-to-rename-cdsco.html Fri, 07 Sep 2018 13:55:00 +0530 The Union Health Ministry is in the process of receiving suggestions for renaming the country's drug regulator Central Drugs Standard Control Organisation (CDSCO) in line with its expanded roles. The name CDSCO was given keeping its role when it was created, but the present nomenclature does not seem to be reflecting its roles and responsibilities. The role of CDSCO has expanded to several areas, including regulation of new drugs, vaccines and clinical trials, all imports pertaining to drugs, medical devices and cosmetics, Central Licensing Approval Authority for blood banks and vaccines, setting of standards under the Drugs and Cosmetics Act, 1940, among others. The Drugs Technical Advisory Board (DTAB) had previously recommended renaming CDSCO as Indian Drugs Administration, or Indian Medical Products Administration. ]]> https://biospectrumindia.com/news/22/11603/health-for-all-resonates-at-who-regional-committee-session-.html https://biospectrumindia.com/news/22/11603/health-for-all-resonates-at-who-regional-committee-session-.html Tue, 04 Sep 2018 10:15:00 +0530 Health ministers and experts from countries in WHO South-East Asia Region recently began five day deliberations on priority issues, emphasizing on universal health coverage for ensuring health for all.“Universal Health Coverage is at the core of Sustainable Development Goal 3 and can be a very powerful tool for social, gender and economic equity,” said J P Nadda, India’s Minister of Health and Family Welfare, inaugurating the Seventy-first session of the WHO Regional Committee for South-East Asia here.The year 2018 is also the 40th anniversary of the historic Alma-Ata Declaration, and due to our collective efforts, the Region is better prepared, and is accelerating progress toward the shared global vision of health for all through universal health coverage, he said.Nadda said India has fast-tracked many initiatives aimed at achieving all the core tenets of universal health coverage - strengthening health systems, improving access to free medicines & diagnostics and reducing catastrophic healthcare spending.Speaking at the inauguration, Dr Poonam Khetrapal Singh, Regional Director WHO South-East Asia, said, WHO’s new global thrust aims to have one billion more people benefitting from universal coverage; one billion more people protected from disaster, and one billion more people enjoying better health as we tackle the many determinants of ill health that lie beyond the reach of the health sector.The WHO South-East Asia Region’s priority programmes are already aligned to these goals and the Region is witnessing growing support for health from the highest levels of government, and impressive progress and achievements.WHO Deputy Director General, Jane Elizabeth Ellison, said, “building on the Region’s achievements we look to the many challenges ahead and our agenda this week draws our discussions to a wide range of vital subjects; from the need to improving civil registration and vital statistics to increasing action on improved vector management for better control of malaria and dengue; from progress in child survival to the promotion physical activity.Amitabh Kant, Chief Executive Officer of National Institute of Transforming India, and Preeti Sudan, Health Secretary, Ministry of Health and Family Planning, spoke at the inaugural and shared the various initiatives being taken by India to improve health and wellbeing of people.Marking 70 years of WHO in South-East Asia Region, a special commemorative document was released by Nadda, Dr Khetrapal Singh, Jane and other ministers/ heads of delegation from WHO South-East Asia Region and other dignitaries.WHO Director-General Dr Tedros Adhanom Ghebreyesus, will be joining the Regional Committee session later in the week.Representatives of a number of partner organizations and civil society are participating in the meeting that is expected to adopt resolutions on key health issues.The Regional Committee session, the highest policy making body of WHO in the Region, is hosted annually by any one of the 11 Member countries in the Region, or the WHO South-East Asia Regional Office. The session this year is being hosted by the Regional Office.  ]]> https://biospectrumindia.com/news/22/11601/health-ministry-declares-draft-rules-for-e-pharmacies-.html https://biospectrumindia.com/news/22/11601/health-ministry-declares-draft-rules-for-e-pharmacies-.html Mon, 03 Sep 2018 13:20:00 +0530 Online pharmacies will need to register with the government of India to sell medicines through the internet and will be bound a set of new draft rules that were notified by the health ministry recently. The new draft rules require online pharmacies to be registered with the Central Drugs Standard Control Organization (CDSCO) and obtain a trade licence applicable across India from any state government. As per the estimates, the total e-pharma industry is less than 0.5% of the retail pharmacy landscape currently, but is growing at more than 100% rate. The already existing Rs 3000 crore online pharmacy business will be streamlined. “Any person who intends to conduct business of e-pharmacy shall apply for the grant of registration to the Central Licensing Authority through the online portal of the Central Government,” reads the notification. The drugs sold online would need prescription and the pharmacy will have to maintain a detailed record. However, there should be strict confidentiality and no patient information should be leaked domestically or internationally. There should also be facility for customer support and grievance redressal. The draft rules also ban the sale of narcotics, psychotropic drugs and tranquillizers. “The work to regulate online pharmacies, or e-pharmacies, has been going on for the past two-three years. We had created a rough draft earlier and made it public for comments. In the final draft that has been Gazette notified, we have incorporated all relevant suggestions,” says Dr S Eswara Reddy, Drug Controller General of India (DCGI). The ministry decided to make amendments to the Drugs and Cosmetic Rules, 1945, to include e-pharmacies as with the growing e-commerce in India, online pharmacies have also been becoming popular in India. According to Reddy, The online store will be of great help for people who cannot access medical stores due to chronic conditions or for people who live in difficult-to-reach terrains where some medicine may not be available. ]]> https://biospectrumindia.com/news/22/11594/who-se-asia-countries-to-discuss-priority-health-issues-in-delhi.html https://biospectrumindia.com/news/22/11594/who-se-asia-countries-to-discuss-priority-health-issues-in-delhi.html Fri, 31 Aug 2018 15:00:00 +0530 Intensifying action to eliminate malaria, addressing the increasing threat of dengue, to improving access to essential medicines, Member countries of WHO South-East Asia Region are meeting here from 3 to 7 September to discuss priority health issues in the Region, home to one-fourth of the world’s population. Health ministers and senior officials from the 11 Member countries are expected to participate in the Seventy-first Session of the Regional Committee of WHO South-East Asia Region, the highest policy making body of WHO in the Region. WHO Director-General Dr Tedros Adhanom Ghebreyesus, WHO South-East Asia Regional Director Dr Poonam Khetrapal Singh, and WHO Deputy Director General Ms Jane Elizabeth Ellison will be participating in the meeting, along with representatives of a number of partner organizations and civil society. The meeting will deliberate on the existing and new opportunities for improving access to essential medicines, vaccines and medical products both within WHO South-East Asia Region and beyond, as one of the key initiatives towards universal health coverage. With the Region prone to disasters and public health emergencies, WHO and Member countries will discuss strengthening of emergency medical teams, an important initiative to fortify response capacities. To address the significant increase in dengue cases in recent years, health experts will discuss measures against all vector-borne diseases including chikungunya and zika. Building on the momentum created in the Region in recent years to eliminate malaria, the Member countries will review key action points for further intensifying efforts to reduce its disease burden. The progress being made by countries to reduce newborn, under-5 and maternal mortalities and the efforts to strengthen health workforce in the Region are among the other key issues to be discussed in the five-day meeting. In addition, progress reports on promoting physical activity, intensifying routine immunization, improving civil registration and vital statistics and expanding the scope of the South-East Asia Regional Emergency Fund, would be made at the meeting. The Regional Committee session is held annually and is hosted by one of the 11 Member countries in the Region or the WHO South-East Asia Regional Office. The session this year is being hosted by the WHO South-East Asia Regional Office.   ]]> https://biospectrumindia.com/news/22/11576/eu-india-engage-to-develop-nextgen-influenza-vaccine.html https://biospectrumindia.com/news/22/11576/eu-india-engage-to-develop-nextgen-influenza-vaccine.html Thu, 30 Aug 2018 12:05:00 +0530 The European Union (EU) and India has announced that they will engage together on research and innovation to develop a Next Generation Influenza Vaccine to Protect Citizens Worldwide. In total, EUR 30 million (or approximately INR 240crs.) has been earmarked for research and innovation actions, which aim at advancing the efficacy, safety, duration of immunity, and reactivity against an increased breadth of influenza strains. Both the EU and the Department of Biotechnology (DBT), Government of India, have committed EUR 15 million each to fund this joint call. The EU is funding this call under its programmer for research and innovation ‘Horizon 2020’ (2014-2020). These joint efforts also aim to develop cost-effective and affordable influenza vaccine rapidly without compromising quality. Keeping this in mind, the participating consortia need to bring together multi-disciplinary stakeholders representing the complete value chain from Lab to Market including pre-clinical trials and vaccine developers. The call was launched on 28th August 2018 in the presence of H.E. Mr Tomasz Kozlowski, Ambassador of the European Union to India and Dr Renu Swarup, Secretary of the Department of Biotechnology (DBT). Dr. Renu Swarup, Secretary, Department of Biotechnology, Government of India said “Europe and India have a long and successful tradition of vaccine in both public and private institutions. Both are also home to many of the world’s largest vaccine manufacturers. Europe and India are therefore well positioned to take on new challenges in vaccine research and exploit the immense opportunity this joint initiative provides India and EU researchers, academicians and industry to come together and find solutions for the challenges posed by the fast mutating influenza strains”. H.E. Mr. Tomasz Kozlowski, Ambassador of the European Union, said: “This joint call is another demonstration of the increased cooperation between the EU and India as committed by the leaders during the Summit in October 2017. In engaging jointly on this topic, India and the EU are contributing to an important global public health challenge. Improved influenza vaccines would help the international community to better prepare in the event of an influenza pandemic.” It is expected that the outcome of the projects will also contribute to the achievement of Sustainable Development Goal 3 to ensure health and well-being for all and boost the Indian National Health Mission. Addressing seasonal flu vaccination is also high on the EU health agenda with the European Commission urging EU Member States to commit to vaccinating 75% of risk groups against seasonal flu each year. The call will remain open till 16th April 2019. The projects require minimum three applicants from Europe (from three different EU Member States or countries associated to the EU programme Horizon 2020) and minimum three applicants from India. This call is also ‘Open to the World’ and thus applicants from other countries can join the EU-India consortia. About 100 participants, both from India and Europe, attended the first information event organized in New Delhi on 28th August 2018. This allowed for a better understanding of the call and matchmaking. The next information sessions will take place in Hyderabad on 30th August, in Bangalore on 24th September and in Pune on 28th September 2018. This cooperation is another demonstration of the already robust cooperation between the EU and India based on the EU-India Science & Technology Cooperation Agreement concluded in 2001 and renewed in 2015 until 2020. On the mobility grants known as Marie Skłodowska-Curie Actions (MSCAs), which are part of Horizon 2020, India ranks first in terms of number of beneficiaries from third countries followed by China and USA. At the EU-India Summit in October 2017, it was agreed to upscale the collaborative research through co-funded and joint calls.           ]]> https://biospectrumindia.com/news/22/11573/odisha-in-a-bid-to-fight-malaria.html https://biospectrumindia.com/news/22/11573/odisha-in-a-bid-to-fight-malaria.html Thu, 30 Aug 2018 09:25:00 +0530 Odisha government has recently signed a Memorandum of Understanding (MoU) with an America-based agency ‘Malaria No More’ and another Indian agency ‘Malaria Elimination Trust’ in a bid to make the state malaria-free. The state Health department inked the pact in the presence of Health Minister Pratap Jena at the State Secretariat. Health Commissioner-cum-Secretary Pramod Kumar Meherda, Health Director Dr Brajakishore Brahma, ‘Malaria No More’ CEO Martin Enlund and ‘Malaria Elimination Trust’ trustee Dr Koushik Sarkar were also present during the MoU signing ceremony. Apart from helping the State Government in chalking out strategy for malaria eradication, the two agencies will also prepare roadmap for massive public awareness and will work towards maintaining coordination with both government and non-government agencies. Odisha government under its ‘Daman’ programme has distributed 1.13 crore medicated mosquito-nets to the people across the state while sensitising people through various mediums. ]]> https://biospectrumindia.com/news/22/11528/arc-holds-two-child-policy-against-national-interest.html https://biospectrumindia.com/news/22/11528/arc-holds-two-child-policy-against-national-interest.html Wed, 22 Aug 2018 13:05:00 +0530 Advocating Reproductive Choices (ARC) coalition are concerned with this well-intentioned but ill- informed initiative that is detrimental to the national interests and development priorities.   The corelation between India’s demographics and population growth India has been experiencing a slowing down in population growth, a decline in fertility rate, an increasing average lifespan and an increase in the working age population. National Family Health Survey 4, 2015-16 (NFHS4)  data indicates 24 states in India have already achieved replacement level fertility. In the last decade, India’s total fertility rate (TFR) has gone down from 2.7 to 2.2, which is very close to the desired replacement level fertility at 2.1. However, five states in northern India: Bihar, Jharkhand, Madhya Pradesh, Rajasthan and Uttar Pradesh contribute to 40% of the population and there are huge disparities in total fertility rates at the district level, even within these states. Certain drivers of population growth deserve attention:   The population momentum due to large young population being in childbearing years, will account for more than 70% of projected population increase. The absolute numbers will continue to increase substantially even if each couple had only one child. The only way to slow down the momentum is to delay age at marriage, delay the first pregnancy and ensure spacing between births.   The unmet need for contraception is 13%, which contributes 20% of projected population growth. This means that over 30 million married women of reproductive age are not able to access contraception (NFHS-4).   Nearly 10% of the projected population growth can be attributed to social factors including families having more children than they actually want, to compensate for high infant mortalities, son preference due to patriarchal social norms etc.   Experiences from within India indicate that coercive policies have never worked There is no evidence on the effectiveness of two-child norm. Similar policies in states like Uttar Pradesh and Bihar have failed to bring down the fertility rates to the desired level. On the other hand, there has been a steep rise in sex-selective and unsafe abortions; men have deserted their wives to run for local body elections, and families give up children for adoption. (Buch 2005.) It is important to note here that States such as Kerala, Andhra Pradesh and Tamil Nadu have experienced significant reduction in fertility rates without any coercive methods. This has been achieved by empowering women and by providing better education and health care facilities.   Global lessons that can inspire us. Let us not fall for the same mistake again  Thanks to the one child policy in China m the country now finds itself in the midst of a population crisis, leading to an imbalanced age structure and sex ratio. In 2015, China had to roll back this policy. South Korea switched to a pro-natalist policy to increase the TFR from 1.08 to 1.6 by 2020, post experiencing the consequences of an aging population, rising social security and healthcare costs, and a shrinking labour force (Mahmoudi 2017). Sri Lanka could reduce its fertility rate by integrating family planning with maternal and child health programs for three decades and Bangladesh by lowering infant, child and maternal mortality through immunization, prenatal and post-natal care in villages (Abeykoon 2011), (Risvi 2018).   Two Child Norm persecutes the marginalised especially women, violates her reproductive rights Imposing a two-child policy will further deprive the poorest, weakest and the most marginalised, especially women. There are evidences of men deserting their families to contest local body elections and children being given-up for adoption. Children are denied of rights and entitlements for no fault of their own. The number of women representatives in local bodies also reduced. Restricting policies lead to a stark increase in sex-selective abortions and female foeticide, given the changing social norms in terms of son meta-preference (desire for a male child). Economic Survey 2017-18 mentions a staggering 21 million ‘unwanted girls’ in India. Failure to address social norms that determine family planning decisions will be a violation of women’s reproductive rights, and cause a further imbalance in the sex ratio. The outcome of the two-child policy in states such as Haryana and Punjab have witnessed highly skewed sex ratios with lesser number of women to men. Consequences include women forced into sex trade, enslavement; physical abuse and eventual abandonment.   Two Child Norm violates fundamental human rights and our constitutional provisions India is a signatory to the Program of Actions, International Conference on Population and Development (ICPD, 1994). The Program of Action states that the “aim of family-planning programmes must be to enable couples and individuals to decide freely and responsibly the number and spacing of their children and to have the information and means to do so and to ensure informed choices and make available a full range of safe and effective methods. The principle of informed free choice is essential to the long-term success of family planning programmes. Any form of coercion has no part to play.” India’s own National Population Policy (NPP) has a stated objective to “address the unmet needs for contraception, health care infrastructure, and health personnel, and to provide integrated service delivery for basic reproductive and child health care”. NPP includes a commitment towards “voluntary and informed choice and consent of citizens while availing reproductive health care services, and continuation of the target-free approach in administering family planning services”. Any coercive norm or measure to curb informed choice and decisions of citizens violate tenets of fundamental human rights.   Population Growth is a socio-economic problem; warrants a socio-economic solution The population growth that India has is solely because of lack of education, lack of access to health facilities and high-unmet need for family planning services. Majority of our population is in reproductive age and 30 million married women of reproductive age are not able to access contraception. Women across rural and urban areas would like to have to have only one or maximum two children (NFHS-4, total desired fertility rate is 1.8). When they are already well informed, why not give them an enabling and empowering environment to help realise their choices rather than imposing a policy? Reduction in maternal mortality and infant mortality by ensuring access to affordable and quality health care will automatically reduce population growth.   - Advocating Reproductive Choices (ARC) ]]> https://biospectrumindia.com/news/22/11524/cam-signs-pact-to-implement-ayushman-bharat.html https://biospectrumindia.com/news/22/11524/cam-signs-pact-to-implement-ayushman-bharat.html Tue, 21 Aug 2018 18:50:00 +0530 Charutar Arogya Mandal (CAM) has signed a Memorandum of Understanding (MoU) with National Health Systems Resource Centre (NHSRC) of State Health Society, Gujarat to provide technical support for implementing Ayushman Bharat programme in Dahod district. CAM’s chief executive officer (CEO) Sandeep Desai, extension programme head Dr Shyamsundar Raithatha and mission director of National Health Mission, Gujarat, Dr Gaurav Dahiya were present during the signing of the agreement. Earlier, CAM was selected as an innovation and learning centre for providing technical support to the government at national and state level to roll out Ayushman Bharat programme’s comprehensive health and wellness centre initiative. ]]> https://biospectrumindia.com/news/22/11494/price-capping-on-knee-implants-gets-further-extension.html https://biospectrumindia.com/news/22/11494/price-capping-on-knee-implants-gets-further-extension.html Thu, 16 Aug 2018 11:25:00 +0530 The government has extended for a year the cap on prices for knee implants, ranging from Rs 54,000 to Rs 1.14 lakh. Providing relief to patients going for knee implants, the National Pharmaceutical Pricing Authority (NPPA) has extended the ceiling prices till August 2019. In August last year, the government had capped prices of knee implants at a significantly lower rate than the market rates. As part of the initiative, NPPA had capped the price of widely used Cromium Cobalt knee implants at Rs 54,720. Prior to that it used to cost between Rs 1.58 lakh and Rs 2.5 lakh. The new MRP of special metal titanium and oxidised zirconium was fixed at Rs 76,600 plus GST, 69 per cent lower than an average rate of Rs 2,49,251 earlier. ]]> https://biospectrumindia.com/news/22/11483/sjvn-collaborates-with-helpage-india-for-health-camps.html https://biospectrumindia.com/news/22/11483/sjvn-collaborates-with-helpage-india-for-health-camps.html Tue, 14 Aug 2018 11:10:00 +0530 Himachal Pradesh (HP) based Satluj Jal Vidyut Nigam (SJVN) has entered into a Memorandum of Understanding (MoU) with HelpAge India for health camps in different states. SJVN is joint venture, with the HP government also having equity share in the Central Public Sector Unit. As per the MoU, financial assistance of Rs 32 lakh will be provided for conducting 20 health camps in the states of HP, Uttarakhand, Bihar and Maharashtra. The camps are being organised in the areas of Ophthalmology, gynaecology, dental, ENT, general health etc. During the camps health awareness lectures will also be delivered by health experts. In the area of health, SJVN is operating 14 mobile health vans in the states of HP, Uttrakhand, Bihar and Maharashtra which have benefitted more than 5 lakh patients. Besides 150 health camps have been organised benefitting around over 50,000 patients. Also, projects for disable section of society like financial assistance to Indian Association of Muscular Dystrophy for construction on integrated muscular dystrophy center, construction of special school at Dhalli etc. are being implemented. ]]> https://biospectrumindia.com/news/22/11471/telangana-attracted-over-rs-10k-cr-in-life-sciences-in-past-4-years-.html https://biospectrumindia.com/news/22/11471/telangana-attracted-over-rs-10k-cr-in-life-sciences-in-past-4-years-.html Mon, 13 Aug 2018 13:10:00 +0530 Telangana, already home to pharma majors such as Aurobindo Pharma and Dr Reddy's, attracted over Rs 10,000 crore investments in the life sciences sector in the past four years, the state government has said. This included Rs 3,000 crore in research and develoment (R&D), the government said adding its aim was to take the overall industry size to USD 100 billion in the future. After the introduction of TS-iPASS (Telangana Industrial Policy) in 2015, about 700 investment proposals, including over 100 in R&D, had been approved by the state government and of this 80 per cent were in the stage of project execution. The past four years have also seen the states life sciences sector being a magnet for investments of about Rs 10,222 crore, including Rs 3000 crore in R&D alone. We are happy that our policies are bearing fruit," state IT and Industries Minister K T Ramarao said. Noting that the life sciences sector added value to the lives of the people and brought laurels to the state and the country, he said the government was committed to fostering its the growth. "We are dreaming big we want to double the size of the sector to USD 100 bn dollars, Telangana Minister for IT and Industries K T Rama Rao said. The state has become home for pharma majors such as Ferring Pharma, Chemo, GSK, Syngene, Slayback Pharma, Johnson & Johnson among others. The investments envisage about 20,000 high value R&D employments and around 50,000 manufacturing jobs in the state. The contribution of Life Sciences sector to the overall product export value from Telangana was "a whopping" 36 per cent, which has almost doubled during the last four years. With the focus on cluster development initiatives such as Hyderabad Pharma City, Genome Valley 2.0 and the Medical Devices Park among others, the government extended "a red carpet to industry". The government had partnered with the US Pharmacopeia, an industry body that sets the standards for drugs, to set up a training institute for university graduates and pharma professionals addressing the skill gap on regulatory and data. ]]> https://biospectrumindia.com/news/22/11465/cabinet-approves-mou-between-india-indonesia-on-health-cooperation.html https://biospectrumindia.com/news/22/11465/cabinet-approves-mou-between-india-indonesia-on-health-cooperation.html Mon, 13 Aug 2018 10:40:00 +0530 The Union Cabinet chaired by Prime Minister Narendra Modi has approved the signing of the Memorandum of Understanding (MoU) between India and Indonesia on health cooperation. The MoU covers the following areas of cooperation:- Research and development, active pharmaceutical ingredients (API) and IT-based medical equipment; Human Resource Development; Health services; and Any other area as may be mutually agreed upon.  A Working Group will be set up to further elaborate the details of cooperation and to oversee the implementation of this MoU. ]]> https://biospectrumindia.com/news/22/11460/haryana-to-roll-out-ayushman-bharat-scheme-on-aug-15.html https://biospectrumindia.com/news/22/11460/haryana-to-roll-out-ayushman-bharat-scheme-on-aug-15.html Fri, 10 Aug 2018 15:25:00 +0530 The Haryana government has said it will launch the Ayushman Bharat-Haryana Health Protection Mission on August 15 to provide cashless healthcare facilities to beneficiaries at empanelled hospitals. On a pilot basis, the scheme would be implemented in one government hospital in each of the 22 districts, one ESI hospital and one medical college. A decision to this effect was taken in a meeting held under the chairmanship of Chief Minister Manohar Lal Khattar, an official release has said. Under the scheme, families identified by the Socio-Economic and Caste Census (SECC) would be provided with coverage of Rs 5 lakh. Every family figuring in the defined SECC 2011 database would be entitled to claim benefits under the scheme. Each beneficiary would be issued a card with a unique QR code and he/she would have to produce it at the hospital. The chief minister directed the hospitals to stock up on medicines so that patients did not need to purchase them from outside. It was informed that all necessary arrangements have been made for the pilot launch of the Ayushman Bharat-Haryana Health Protection Mission in the State. A total of 15.50 lakhs families, including 9,25,014 in rural and 6,26,761 in urban areas, that figure in the SECC-2011 database would be entitled to claim the benefits, the release said. It said 58 government and 32 private hospitals in the state would be empanelled for successful implementation of the scheme by August 15 for the pilot project. Work is in progress to empanel more hospitals. Out of 1,350 treatment packages provided by the government of India, about 266 packages would be reserved by the state government for public healthcare system in government hospitals of the state, the statement said. The Department of Medical Education and Research has been asked to empanel the medical colleges or hospitals in the Ayushman Bharat Scheme. Similarly, the Labour department has been asked to empanel the ESI Medical College and hospitals under the scheme. The release said Ayush Mitras would be appointed in all empanelled government hospitals to assist patients in availing the facilities under the scheme. Earlier, the chief minister also launched the website of the Ayushman Bharat-Haryana Health Protection Mission. ]]> https://biospectrumindia.com/news/22/11436/health-ministry-addresses-regulatory-issues-related-to-oxytocin.html https://biospectrumindia.com/news/22/11436/health-ministry-addresses-regulatory-issues-related-to-oxytocin.html Tue, 07 Aug 2018 10:40:00 +0530 The Health Ministry recently held a video conference with the States/UTs on various issues relating to regulation of Oxytocin including the status of preparedness of the State Governments for implementing the amended rules in regard to manufacture, distribution and sale of Oxytocin. The video conference also assessed the stock of Oxytocin in the States to ensure that there is no shortage after the restriction order on its manufacture for domestic use comes into effect from 1st September, 2018. R K Vats, Additional Secretary and DG (CGHS) and Manoj Jhalani (Ayushman Bharat Scheme Mission Director) chaired the video conference meeting. Vandana Gurnani, JS and Sudhir Kumar, JS, along with Dr Ishwar Reddy, DGCI and the other senior officers of the Ministry also attended the meeting. Principal Secretaries and Mission Directors from States/UTs and the KAPL team participated in the video conference. In the meeting, Manoj Jhalani clarified that Oxytocin has not been banned in the country, only its manufacture for domestic market has been restricted in the public sector through Karnataka Antibiotics and Pharmaceuticals Ltd. (KAPL) with effect from 1st September, 2018. He further said that the private manufacturers of oxytocin can very well manufacture the drug for export purpose. Jhalani also emphasized that the government will ensure that there is no shortage of Oxytocin when the changed dispensation comes into effect. The States were requested to ensure availability of Oxytocin Injection in all Government hospitals/clinics by placing purchase order to KAPL Ltd. As Oxytocin Injection is a lifesaving drug and now with its restricted manufacture and sale through KAPL, all procurement agencies of State Governments shall ensure sufficient stocks are available at any given point of time. Jhalani emphasized that all States shall keep a vigil on any artificial shortage of Oxytocin Injection in their States. The States Authorities were also asked to ensure availability of Oxytocin Injection in all government hospitals by placing orders to KAPL and also have meeting with all stakeholders like FOGSI, IMA, PMBJP, etc., to ensure its availability in all private clinics also. The States have been advised to assess their requirement of the drug and to place the orders with KAPL in time.  Most states indicated that they have sufficient stock, and would also be placing orders to meet the requirement of Government sector hospitals. KAPL requested the states to place their orders in advance for bulk procurement. KAPL assured that they have the required manufacturing capacity. KAPL also assured to maintain the adequate quality of the drugs. It has started a 24 hour Helpline number: 080- 23577595. It also assured that it shall be revising its bulk purchase pricing. The Government also asked the States to mount an awareness campaigns about the government notification on restricting the manufacture and sale of Oxytocin restricting to KAPL and asked KAPL Ltd to ensure a robust supply chain to prevent any stock outs. The Ministry shall be reviewing the production and distribution of Oxytocin drug on a regular basis. ]]> https://biospectrumindia.com/news/22/11424/karnataka-gearing-up-for-21st-edition-of-bengaluru-tech-summit.html https://biospectrumindia.com/news/22/11424/karnataka-gearing-up-for-21st-edition-of-bengaluru-tech-summit.html Fri, 03 Aug 2018 15:40:00 +0530 (L-R- Shailendra Kumar Tyagi, Director, STPI; Gaurav Gupta, Principal Secretary, Department of Commerce & Industries and Department of IT, BT and Science & Technology; K.J.George, Minister for Large & Medium Scale Industries, Sugar, IT & BT, and Science and Technology, Govt of Karnataka; Kris Gopalakrishnan, Co-founder, Infosys Ltd.; Chairman, Vision Group on IT, Govt of Karnataka; Krishnakumar Natarajan, CEO & MD, Mindtree, Chairman, Conference Committee, Bengaluru Tech Summit 2018; K Nagaraj, Director, Dept of IT&BT and MD KBITS, Govt of Karnataka)   The Department of IT, BT, Government of Karnataka is organizing the 21st edition of its flagship event Bengaluru Tech Summit from 29th November to 1st December, 2018 at Bengaluru Palace with the focal theme Innovation & Impact. The event spectrum would include multi-track conference, B2B Expo, Thought Leaders Conclave, IT Export Awards, Bio Excellence Awards, Bengaluru Tech Exchange, Show Stoppers- Product Launch and Global Innovation Zone, Startups, and posters. The conference will have over 250 experts addressing 3500+ delegates and 300+ exhibitors showcasing their services, products and technologies to 11000+ visitors. At the recently held curtain raiser press conference for the 21st edition of Bengaluru Tech Summit, K J George, Minister for Large & Medium Scale Industries, IT & BT, S&T, Govt. of Karnataka said, “Karnataka is the torch bearer for IT & BT industry. The government is committed to the startup ecosystem to drive Karnataka and the nation’s growth. This event will provide an excellent opportunity to both industry and stakeholders to connect with the best minds to explore how to fuel their business growth”. Gaurav Gupta, Principal Secretary, Dept. of Commerce & Industries, Dept of IT, BT, S&T stated, “Bengaluru Tech Summit has been instrumental in promoting the IT industry for more than two decades. This year’s event is primarily focused on three agendas- Emerging Technologies, Startups and Global Alliances”. Before going ahead with the curtain raiser press conference, Karnataka Government officials got together with the industry experts over breakfast to discuss the key agendas and policies in store for the upcoming event. The breakfast meet was directly followed by a detailed meeting with the officials from different countries who showed keen interest in getting associated with the Bengaluru Tech Summit. The upcoming Bengaluru Tech Summit is all set to offer fantastic opportunity for entrepreneurs, developers, students and others to mingle, reach out and discover the Indian Tech innovation ecosystem. ]]> https://biospectrumindia.com/news/22/11402/nha-signs-mou-for-ayushman-bharat-implementation.html https://biospectrumindia.com/news/22/11402/nha-signs-mou-for-ayushman-bharat-implementation.html Wed, 01 Aug 2018 11:25:00 +0530 National Health Agency (NHA), the apex body for the implementation of Ayushman Bharat-National Health Protection Mission (AB-NHPM) has signed a Memorandum of Understanding (MoU) to provide information and eligibility validation services to beneficiaries, especially in remote areas. J P Nadda, Minister of Health and Family Welfare and Ravi Shankar Prasad, Union Minister for Law and Justice & Information Technology presided over the MoU signing ceremony. As the benefits under AB-NHPM are based on entitlement and not on enrolment, over 3 lakh Common Service Centres (CSCs) spread across the rural India can become the key point of information for potential beneficiaries and help in validating their entitlement. The MoU was signed by Dr. Indu Bhushan, CEO, National Health Agency (NHA) and Dr. Dinesh Tyagi, CEO, CSC-SPV. ]]> https://biospectrumindia.com/news/22/11398/telangana-government-to-establish-a-b-hub-at-genome-valley.html https://biospectrumindia.com/news/22/11398/telangana-government-to-establish-a-b-hub-at-genome-valley.html Wed, 01 Aug 2018 10:30:00 +0530 The Telangana government has said that it plans to establish a B-Hub at Genome Valley here to scale up manufacturing activities for biopharma based Research and Development. The proposed B-Hub, with at an estimated cost of Rs 60 crore, would be set up through Public Private Partnership (PPP) in Genome Valley, India's first organised cluster for life sciences Research & Development and clean manufacturing activities. B-Hub will be a first of its kind initiative in the country, aimed at providing much needed support to the biopharma R&D activities, featuring a scale-up manufacturing facility, along with a turnkey incubator/lab space module at Good Laboratory Practises grade within a built-up area of 40,000 square feet. Establishment of an end-to-end biopharma scale-up manufacturing facility would give domestic companies the required impetus viz-a-viz Korea, China and France who have taken lead in biopharma innovation. Companies in early stage clinical development, but lacking the requisite expertise and resources to navigate the complexities associated with business planning, cell line development, process development, technology, and/or regulatory and risk assessment, can leverage B-Hub facility to help break down roadblocks and improve the likelihood of commercial success. Meanwhile Telangana Minister for IT and Industries K T Rama Rao has also launched a web portal for the life sciences sector, aimed at creating an interface between the government, Industries, Research Institutions and Start-ups. Telangana, which has emerged as the 'Pharma capital of India', has set out an ambitious vision for the sector, through leveraging its existing strengths, to create four lakh jobs at an investment of USD 100 Billion in the next 10 years. ]]> https://biospectrumindia.com/news/22/11379/india-launches-viral-hepatitis-control-programme.html https://biospectrumindia.com/news/22/11379/india-launches-viral-hepatitis-control-programme.html Mon, 30 Jul 2018 11:00:00 +0530 Union Minister of Health and Family Welfare JP Nadda recently launched the National Viral Hepatitis Control Programme to eradicate viral hepatitis by 2030. The programme was launched to mark the World Hepatitis Day 2018. On the same occasion, the minister also released the Operational Guidelines for National Viral Hepatitis Control Programme; National Laboratory Guidelines for Viral Hepatitis Testing; and National Guidelines for Diagnosis and Management of Viral Hepatitis. Highlights of the National Viral Hepatitis Control Programme-  It aims to control viral hepatitis in the country, thus, thereby reducing mortality and morbidity attributed to it.  The key strategies of the programme include preventive interventions with focus on awareness generation, safe injection practices and socio-cultural practices.  It will also focus on ensuring sanitation and hygiene, safe drinking water supply, infection control and immunization.  It aims to increase access to testing and management of viral hepatitis; promote diagnosis and provide treatment support for patients of hepatitis B &C through standardied testing and management protocols with focus on treatment of hepatitis B and C.  It aims to build capacities at national, state, district levels and sub-district level up to Primary Health Centres (PHC) and health and wellness centres to scale up the program to the lowest level of the healthcare facility in a phased manner.  It involves co-ordination and collaboration with different Ministries and departments. ]]> https://biospectrumindia.com/news/22/11367/meghalaya-cabinet-approves-health-plan.html https://biospectrumindia.com/news/22/11367/meghalaya-cabinet-approves-health-plan.html Thu, 26 Jul 2018 11:20:00 +0530 The Meghalaya cabinet has approved the implementation of Meghalaya Health Insurance Scheme (MHIS) phase-IV, converging with the health protection scheme of the Centre, which was launched under Ayushman Bharat Programme. After the cabinet meeting chaired by chief minister Conrad K. Sangma at the main secretariat in Shillong, health minister A.L. Hek informed that the MHIS phase-IV has been approved and the health coverage is upto Rs 5 lakh per year per household. According to Hek, the MHIS phase IV implementation would cover all citizens of the state except government employees. The scheme would cover various tests and investigation of sickness too. ]]> https://biospectrumindia.com/news/22/11333/zydus-cadila-gets-usfda-nod-for-acne-treatment-topical-solution-.html https://biospectrumindia.com/news/22/11333/zydus-cadila-gets-usfda-nod-for-acne-treatment-topical-solution-.html Thu, 19 Jul 2018 17:20:00 +0530 Drug firm Zydus Cadila has said that it has received final approval from the US health regulator to market Clindamycin Phosphate Topical Solution, used to treat acne. The company has received approval from the US Food and Drug Administration (USFDA) to market Clindamycin Phosphate Topical Solution USP (Cleocin T), 1 per cent. Clindamycin is an antibiotic which works by stopping the growth of bacteria. It is used to treat acne and helps to decrease the number of acne lesions. The company said it will manufacture the product at the group's topical manufacturing facility in Ahmedabad. The company has more than 204 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04.   ]]> https://biospectrumindia.com/news/22/11304/india-bahrain-sign-pact-for-healthcare-opportunities.html https://biospectrumindia.com/news/22/11304/india-bahrain-sign-pact-for-healthcare-opportunities.html Mon, 16 Jul 2018 13:30:00 +0530 India and Bahrain have agreed to make pharmaceuticals a key area of cooperation after the second High Joint Commission meeting led by External Affairs Minister Susham Swaraj and Bahraini Foreign Minister Shaikh Khalid Bin Ahmed Bin Mohamed Al Khalifa in Manama. "Bahrain and India agreed to explore opportunities healthcare industry and welcomed the signing of an MoU for cooperation in the field of healthcare, which would contribute in expanding the cooperation between the two countries making pharmaceuticals a key priority area in the bilateral relations," said a joint statement issued following the meeting. India and Bahrain also noted the existing potential for two-way investments and reaffirmed their desire to provide favourable environment for investments, both from public and private sectors, from the two countries. Both sides agreed on the importance of regular and timely exchange of information on available investment opportunities. Both sides discussed in detail various aspects of bilateral relations including "ways and means to expand cooperation in the fields of education, health, housing, renewable energy, space cooperation, tourism, culture, youth and sports, women empowerment, customs, oil and gas and petrochemicals; security, defence and intelligence training and exchange of expertise, cooperation between universities in both countries and the possible exchange of researchers and faculty members in the fields of food security, cyber space and energy. Bilateral trade between India and Bahrain stood at over $875 million as of February this year, according to figures provided by the External Affairs Ministry. India's total capital investment into Bahrain between January 2003 and March 2018 has been estimated at $1.69 billion.   ]]> https://biospectrumindia.com/news/22/11278/safe-point-india-hmd-foundation-appreciate-punjab-cms-action.html https://biospectrumindia.com/news/22/11278/safe-point-india-hmd-foundation-appreciate-punjab-cms-action.html Tue, 10 Jul 2018 17:00:00 +0530 Hailing Punjab CM Amarinder Singh’s prompt decision to revoke the ban on the sale of syringes without a prescription, Safe Point India and HMD Foundation appreciated and thanked CM Amarinder Singh for the much needed timely action. After the order Safe Point India and HMD Foundation raised an alarming concern on the urgent need to amplify this order because restrictive practices can actually compel a user to reuse the old easily available syringes and thereby expose himself and all other members of community to various infections and health hazard of undetermined proportions adding to already huge burden of HIV/ Hep B /Hep C infections and a host of other diseases. Punjab Chief Minister Amarinder Singh on Monday revoked the ban on the sale of syringes without a prescription. The Chief Minister’s Office has directed deputy commissioners across the state to issue orders to chemists to prepare an inventory of syringes and keep a record of their sale and the customers sold to. “We do not know why the respective Deputy Commissioners issued such ban orders. There was no direction from the state government. We will amend it,” said a functionary. At least three district administrations, Faridkot, Bathinda and Fazilka have issued directives to medical stores to not sell syringes without a doctor’s written prescription.  The order issued by the deputy commissioner using the power under section 144 of CrPC will come into effect immediately and last till September 30, 2018. “Instead of restriction to syringes access it would be more prudent to accelerate a switch to Auto Disable Syringes in Punjab and have a State policy similar to the one by Government of Andhra Pradesh to prevent reuse with the help of State Drug Controller to address this magnifying problem” said Pardeep Sareen, Chief General Manager-Marketing, Hindustan Syringe and Medical Devices Ltd. Mr. Sareen said Punjab has the highest incidence of hepatitis B and C spreading from drug addicts to other patients in the already-challenged healthcare infrastructure. “The order was distraught with trouble. We are thankful to CM Amarinder Singh for timely intervention. While the law exists in the US of syringe sale limited to prescription, this is not the case in India and the intent of solving a problem may be noble but the management tool being used is questionable and the wrong prescription as it will lead to bigger problem of infections being spread from Syringes reused. In other countries they promote free Needle exchange programs to addicts to motivate them not to share Syringes or reuse them ” Said Mr Rajiv Nath , Jt. Mg. Director of Hindustan Syringes & Medical Devices.  The disposable syringes available in market are subject to re-use. Numerous and periodic media reports and case studies have identified reuse of syringes and needles as a major cause of spread of diseases. “In order to prevent reuse and contain spread of infection, it is advisable and recommended to use AD syringes specifically designed to prevent reuse. This reuse prevention has been strongly advocated by WHO, MoH&FW  has been seeking manufacturers to add capacity of AD Syringes and  the recently concluded HTA study from PGI chandigarh  on safety engineered devices under aegis of Punjab government and DHR, MoH, GoI had again proven the cost effectiveness of this intervention ” emphasised Dr Ratti , Healthcare Advisor, Safe Point India “Andhra Pradesh government has already taken a lead in this regard and issued instructions for 100% use of AD syringes in its public health facilities from 28th Jul 2018which is observed as World Hepatitis Day. Currently AD syringes are used in immunization programs only in most states though many Central Govt hospitals in Delhi are using these for years.” Dr. Ratti added. Safe Point India and HMD Foundation which work in areas of promoting safe injection practices through policy advocacy and safe and proper use of injection practices including its safe disposal has been urging Central and State governments to adopt use of AD syringes in therapeutic practices also. Safe Point India therefore urged that Punjab government order be suitably amended to include:   All prescriptions must specify use of AD syringes   It would be more prudent to accelerate a switch to Auto Disable Syringes in private sector in Punjab and have a State policy as done by Government of Andhra Pradesh (issued instructions for 100% use of AD syringes in its public health facilities from 28th Jul 2018 which is observed as World Hepatitis Day) to prevent reuse with help of State Drug Controller to address this magnifying problem in Punjab.   After holding a review meeting on drugs today, the chief minister will issue detailed guidelines on the sale of syringes to all Deputy Commissioners. ]]> https://biospectrumindia.com/news/22/11274/niti-aayog-comes-out-with-a-blueprint-of-the-national-health-stack.html https://biospectrumindia.com/news/22/11274/niti-aayog-comes-out-with-a-blueprint-of-the-national-health-stack.html Tue, 10 Jul 2018 14:30:00 +0530 The NITI Aayog has come out with a blueprint of the the National Health Stack (NHS), a shared digital healthcare infrastructure, with a view to implement the Centre's flagship scheme Ayushman Bharat and other public healthcare programmes in the country. The NHS is proposed to be the country's first futuristic nationally shared digital healthcare infrastructure usable by both the Centre and states across public and private sectors. According to a consultation paper titled 'National Health Stack Strategy and Approach', the NHS will facilitate collection of comprehensive healthcare data across the country. Subsequent data analysis on NHS will not only allow policy makers to experiment with policies, detect fraud in health insurance, measure outcomes and move towards smart policy making, but also engage market players (NGOs, researchers, watchdog organisations) to innovate and build relevant services and fill the gaps, it added. As per the consultation paper, the NHS will provide foundational components that will be required across 'Ayushman Bharat' and other health programmes in India. It will also provide a mechanism through which every user participating in the system can be uniquely identified. "The registrant may create a virtual health ID to preserve their privacy when interacting with other users or stakeholders in the system," the paper said. The National Health Policy 2017 had also envisaged creation of a digital health technology ecosystem aimed at developing an integrated health information system that serves the needs of all stakeholders. As per the proposals, various layers of the NHS will be seamlessly linked to support national health electronic registries, a coverage and claims platform, a federated personal health records framework, a national health analytics platform as well as other horizontal components. "The stack will embrace health management systems of public health programs and socio-demographic data systems," the paper said. Once implemented, the NHS will significantly bring down the costs of health protection, converge disparate systems to ensure a cashless and seamlessly integrated experience for the poorest beneficiaries, and promote wellness across the population, it added. The NHS proposes to allow states to incorporate horizontal and vertical expansion of scheme, avoid duplication of efforts and enable ease of adoption for those without systems or with dysfunctional systems in place, continue using their own state system while integrating with Rashtriya Swasthya Suraksha Mission (RSSM) via Application Programming Interface (APIs), making migration simple in case of states with more advanced systems. The key components of the NHS includes electronic health registries, coverage and claims platform, digital health ID cards, federated personal health records (PHR) framework and the National Health Analytics Framework. The government's flagship scheme Ayushman Bharat aims to provide a coverage of Rs 5 lakh per family annually and benefit more than 10 crore poor families. The Aayog further said that in order to arrive at a well-informed conclusion, it has invited comments from all stakeholders on the consultation paper.   ]]> https://biospectrumindia.com/news/22/11270/india-south-korea-sign-5-mous-in-st.html https://biospectrumindia.com/news/22/11270/india-south-korea-sign-5-mous-in-st.html Tue, 10 Jul 2018 10:20:00 +0530 India and South Korea have signed five MoUs in the field of Science & Technology. Union Minister for Science & Technology, Dr Harsh Vardhan and his South Korean counterpart, Mr. You Young Min signed three MoUs for (i) Programme of Cooperation 2018-21; (ii) Establishment of Future Strategy Group; (iii) Cooperation in Biotechnology & Bioeconomy. The MoU on Establishment of Future Strategy Group was signed by Indian Science & Technology and Commerce Ministers, while on the Korean side, it was signed by Science and ICT and Trade Ministers. Two other MoUs were signed between Council of Scientific & Industrial Research (CSIR), and South Korean National Research Council for Science & Technology and IIT Mumbai and Korea Institute of Science &Technology, to further accelerate future-oriented cooperation in their respective sectors. The MoUs were signed at the conclusion of the 4th India-Korea Science & Technology Ministers Steering Committee Meeting. In the area of biotechnology, New Delhi and Seoul have agreed to extend cooperation in health and medicine, agro-fishery products developed with the adoption of biotechnology; environment-related challenges and developing environmental and energy sectors through bio-technology, big data biotechnology; bio-research resources; synthetic biology, genome editing and microbiomes, etc. The Ministers also agreed to establish a Future Strategic Group, which will build a collaborative platform that can utilize the potential of both the countries towards fostering innovation and create impact which is of social and economic good. To begin with, both sides will be co-funding collaborative enterprise-led joint R&D projects covering (i) Digital Transformation (ii) Future Manufacturing (iii) Future Utilities and (iv) Health Care. Both countries renewed the Programme of Cooperation in the field of Science and Technology for 2018-21 to augment the cooperation in Science, Technology and Innovation. ]]> https://biospectrumindia.com/news/22/11261/indias-medical-export-import-policy-under-scanner.html https://biospectrumindia.com/news/22/11261/indias-medical-export-import-policy-under-scanner.html Mon, 09 Jul 2018 10:30:00 +0530 Prominent public health experts and industry insiders are of the opinion, if India isn’t cautious in the method of calculating trade margin rationalisation, it may face implications on its exports of medical devices. India’s Export-Import policy is constantly under the scanner of the south Asian countries and there have been far too many pieces of evidence. For instance, immediately after the price capping of stents by the Indian government, Pakistan, Sri Lanka and Bangladesh followed suit and got a similar line of price control. In February 2017, India slashed the price of coronary stents by 80%. Immediately, in the same month, Pakistan's senate committee on health directed the health ministry and the Drug Regulatory Authority of Pakistan to formulate a pricing policy on stents within a month. Consequently, in April, Bangladesh too joined the bandwagon; the Directorate General of Drug Administration, contemplated bringing down the current price by half. 6-months later, Sri Lanka followed suit – the prices of the bare-metal stent and the drug-eluting stent was reduced at a similar rate. This clearly proves that any Export-Import policy which GOI will try to implement is clearly pursued by the neighbour ring countries. Albeit, India is considering trade margin rationalisation as an alternative mechanism to price control, the medical device industry is concerned whether the calculation will be balanced and agreeable. The neighbouring countries may again take a page out of India's book and implement similar margins by including only the landed cost. If these countries exporting Indian medical devices also demand a landing cost based selling price, it will be catastrophic for 16 billion USD worth Indian drugs/ device export of India. “The market-based price control mechanism of DPCO 2013 evolved from the past learnings of imposing price control. For instance, when the DPCO in 1995 practised cost-based price capping, it impacted both patients and the industry. There was no new entrant in the market nor any production capacity, as a result, the competition was stagnant, implicating growth and innovation. More importantly, industries ability to invest in enhancing capability building was curtailed. All these are well documented in National Pharmaceutical Pricing Policy 2012. Hence, the government should refrain from going back to the past landed cost/ manufacturing cost-based price capping mechanism and tear down the nascent medical device industry as was the case for bulk drugs,” said Avirup Bose, Associate Professor, Jindal Global Law School. The National Medical Regulatory Authority of Sri Lanka has also initiated the process of trying to match the prices of import with that of the country of origin and other SAARC countries. Subsequently, the Bangladesh Government is also planning to control margins from landing cost for imported medicines. If GOI opts to calculate only the landed cost and the margin, the Indian subsidiaries operating abroad may also suffer and the off-shore subsidiary level expenditure will have to be cut-off severely, affecting Indian export.  “A global company’s subsidiary should be viewed as a domestic firm, with added costs not borne by the typical domestic firm, for purposes of the Trade Margin computation. Trade margin rationalization should be based on a comparable PTT (Price to trade) and not landed cost basis in the case of imports, as it does not consider other intermediate expenses such as training clinicians on the technology, providing technical support to clinicians or patients for the product, investment on creating therapy awareness and skill development of clinicians, financing sales and collection costs in India, paying Indian corporate taxes, and other normal expenses for developing and serving the Indian market," said, Ritesh K Singh, a Public Health Expert and Group Chief Economist, Raymond Limited. Trade margin rationalization based on Department of Pharmaceuticals report on high trade margin rightly addresses the issue of high trade margin escalation as the reason for MRP enhancement. If trade margin proposal is implemented, it is estimated to reduce the MRP by 73 %. This will not only bring inpatient affordability but also allow access to quality healthcare. It will keep the door open for innovation and capability enhancement of the clinicians on newer technologies. So, adopting this proposal to calculate from the first point of sale would encourage innovation, increase affordable access to quality care, support skilling and training and have a significant impact in reducing prices for patients, thereby enhancing India’s competitiveness edge. This presents a win-win situation for all.  ]]> https://biospectrumindia.com/news/22/11248/gardp-who-icmr-to-collaborate-for-studying-sepsis-amr.html https://biospectrumindia.com/news/22/11248/gardp-who-icmr-to-collaborate-for-studying-sepsis-amr.html Thu, 05 Jul 2018 10:35:00 +0530 Global Antibiotic Research and Development Partnership (GARDP), the World Health Organization (WHO) and ICMR jointly organised an event on reducing neonatal and child mortality by addressing drug resistance through collaboration, research, and innovation.  More than 80 researchers from 11 countries recently met in New Delhi to kick off an observational study to understand sepsis in newborns and current antibiotic prescribing practices. This is part of the Global Antibiotic Research and Development Partnership's (GARDP's) broader programme to develop new and improved antibiotic treatments for newborns. The observational study, led by the GARDP, is benefiting from $2 million funding from Bill & Melinda Gates Foundation to support study sites in Bangladesh, India, Kenya, South Africa, and Uganda. The study will generate a robust evidence base on how neonatal sepsis is managed which can be used as a basis for evaluating future interventions in neonates. Outcomes of interest will include mortality, antibiotic use, and duration of antimicrobial therapy. The data generated from the study will inform GARPD's ambition to develop and deliver new antibiotic treatments for newborns with drug-resistant bacterial infections. Limited research on newborns has resulted in a lack of evidence about appropriate treatment of serious and drug-resistant infections in this vulnerable population. Newborns' susceptibility to sepsis is further compounded by the challenges of diagnosing serious bacterial infections since symptoms and signs can be non-specific and difficult to detect. Prof Balram Bhargav Secretary Department of Health Research and Director General ICMR highlighted the importance of a joint role of all the stake holders to reduce Infant mortality rate and Anti microbial resistance (AMR). GARDP established in 2016, is a joint initiative by the World Health Organization (WHO) and the Drugs for Neglected Diseases initiative (DNDi). The Indian Council of Medical Research (ICMR) as a founding partner of DNDi, has been instrumental in GARDP’s set up and programmes in India. ]]> https://biospectrumindia.com/news/22/11216/government-to-launch-a-new-scheme-to-prevent-distress-sales-by-farmers.html https://biospectrumindia.com/news/22/11216/government-to-launch-a-new-scheme-to-prevent-distress-sales-by-farmers.html Fri, 29 Jun 2018 17:10:00 +0530 The ministry of food processing Industries expects approval from the Standing finances Committee for the Rs 500-crore scheme.  The scheme is yet to be finalised. Once everything is decided, the scheme will be presented to the Standing Finance Company. The officials hope to implement it by July.                                                        This programme intends to enhance farmers’ income and create integrated supply chains by focusing on the top 10 major producing clusters for each crop. This will lead to enhancement in the incomes of tomato, onion and potato farmers, capacity building of Farmers Producers Organisations, reduction in post-harvest losses, the creation of processing infrastructure, provision of agri-logistics for supply chain and reduction in price volatility of TOP for consumers.   The scheme will assign approximately 50 crores to each project, giving preference to states that have adopted APMC reforms.   FPOs, cooperatives, companies, food processors, logistic operators, service providers, supply chain operators, retail and wholesale chains and central and state government entities could link up with farmers for quality production of crops, post-harvest processing facilities, storage and preservation facility, primary processing, agri-logistics and marketing support, he said. Financial assistance for production in TOP clusters would be provided under the Mission.           ]]> https://biospectrumindia.com/news/22/11205/cdsco-incorporates-more-medical-devices-in-drug-law.html https://biospectrumindia.com/news/22/11205/cdsco-incorporates-more-medical-devices-in-drug-law.html Thu, 28 Jun 2018 12:30:00 +0530 To control high-quality of significant-finish medical products and tools such as implants, X-ray equipment, MRI and CT scan tools, and dialysis equipment, the wellbeing ministry has proposed to extend the checklist of products under the purview of drug law.   The Central Prescription drugs Standard Management Organisation (CDSCO), the drug high-quality regulator under the ministry, has instructed to incorporate 8 new categories of medical products under the definition of drug, which will be right controlled under the Prescription drugs and Cosmetics Act. At current, only 23 medical products qualify as medications and are monitored for high-quality by the Prescription drugs Controller Common of India (DCGI).   All other medical products are sold without the need of any high-quality checks or medical trials. The latest proposal would indicate organizations will have to do trials in India, submit safety facts and satisfy other these kinds of regulatory specifications to find ahead of in search of acceptance for marketing these kinds of significant-finish important products and solutions.   The checklist proposed by CDSCO contains implantable medical products, MRI tools, CT scan tools, defibrillators, dialysis equipment, PET tools, X-ray equipment and bone marrow cell separator. The regulator has proposed to notify these 8 categories of medical products as ‘drugs,’ under Area 3 of Prescription drugs and Cosmetics Act.   “This will be notified in the official Gazette of India and it will appear into drive soon after a interval of twelve months from the date of its publication,” the regulator said in a general public see inviting opinions from all stakeholders by mid-July. The transfer assumes significance as growing quantity of these kinds of products and solutions are coming into the marketplace with numerous variants and makes.   Several of these products and solutions are life-conserving products, priced exorbitantly and utilised in important treatment. Professional medical system marketplace in India is pegged at all over $7 billion, rising on a yearly basis at 10-12%. Estimates clearly show medical technologies sector has the likely to touch $50 billion by 2025.   At the moment, India imports all over 80% of the medical products. ]]> https://biospectrumindia.com/news/22/11200/cabinet-approves-mou-with-bahrain-for-healthcare.html https://biospectrumindia.com/news/22/11200/cabinet-approves-mou-with-bahrain-for-healthcare.html Thu, 28 Jun 2018 11:10:00 +0530 The Union Cabinet chaired by Prime Minister Narendra Modi has approved the signing of a Memorandum of Understanding (MoU) between India and Bahrain on cooperation in the field of Healthcare. The MoU covers the exchange of information including publications and research outcomes; exchanging visits by governmental officials, academic staff, scholars, teachers, experts and students; participating in workshops and training courses; encouraging health and medical research activities at both the private-sector and the academic level; and any other forms of cooperation as may be mutually decided upon.  A Working Group will be set up to further elaborate the details of cooperation and to oversee the implementation of this MoU. ]]> https://biospectrumindia.com/news/22/11174/ima-rejects-rates-of-medical-procedures-in-ayushman-bharat-scheme.html https://biospectrumindia.com/news/22/11174/ima-rejects-rates-of-medical-procedures-in-ayushman-bharat-scheme.html Mon, 25 Jun 2018 13:00:00 +0530 The Indian Medical Association (IMA), the largest body of practicing doctors in the country has rejected the package rates for various procedures under the Ayushman Bharat National Health Protection Scheme (AB-NHPS). A press statement issued said that the IMA is deeply concerned and rejects the current package rates. "At these rates the Government is exposing patients to danger in hospitals," it said. Earlier, the Association of Healthcare Providers of India (AHPI) had also rejected the package rates on similar grounds. AHPI comprises of hospitals, insurance companies, diagnostic centres and pharma companies as its members. IMA meeting lashed out at Ayushman Bharat officials for not addressing the concerns raised by the IMA and the rigid attitude on unrealistic package rates. The statement said that such low rates will compromise quality and breed corruption and this will have a deleterious effect on patient safety. IMA objections on package rates, fund allocation and insurance model remained unchanged, reported India Today. IMA has also listed out its demands for the scheme. It wants scientific costing should be carried out before fixing the rates. IMA has also objected to the Insurance model of implementation. It has demanded exclusive trust model instead. "At 15 per cent profit, crores of rupees will go into the hands of middle men, present healthcare delivery system would collapse if all stakeholders are not taken into confidence," the statement said.   ]]> https://biospectrumindia.com/news/22/11156/odisha-government-approves-nirmal-healthcare-scheme.html https://biospectrumindia.com/news/22/11156/odisha-government-approves-nirmal-healthcare-scheme.html Thu, 21 Jun 2018 13:45:00 +0530 The Odisha state government has approved Nirmal scheme that would provide various free ancillary services to people at all state-run hospitals. The new scheme will make quality health services affordable for everyone. The health and family welfare department will set up clinics at government hospitals such as those for cancer detection, sterility, family welfare, child rehabilitation, child guidance and child welfare and immunisation. Department officials will also strengthen the services at the facilities where the scheme is already available. "We have already set up centres for cancer detection and family welfare at different state-run hospitals. These will be upgraded as part of the new scheme," said a health and family welfare department official. "We will start taking steps to procure equipment and put up the infrastructure at district headquarters hospitals under the scheme," he said, reported The Telegraph India. Chief minister Naveen Patnaik announced the scheme on April 7 on World Health Day following which health officials and National Health Mission activists swung into action to finalise the modalities for implementation of the scheme. Sources said the clinics would be set up first at Capital Hospital. In later phases, the facilities will come up at district headquarters hospitals. "We are trying to improve health services at state-run hospitals and this is one of our initiatives," said another official. The government has introduced a number of health care schemes, including provisions for free sanitary napkins to adolescent girls, free diagnostic services, free eye care and medicines.   ]]> https://biospectrumindia.com/news/22/11145/india-launches-national-health-resource-repository.html https://biospectrumindia.com/news/22/11145/india-launches-national-health-resource-repository.html Wed, 20 Jun 2018 13:00:00 +0530 Union Health Minister J P Nadda has launched the National Health Resource Repository (NHRR), the country's first-ever national healthcare registry of authentic, standardised and updated geo-spatial data of all public and private healthcare establishments. The vision of National Health Resource Repository project is to strengthen evidence-based decision making and develop a platform for citizen and provider-centric services by creating a robust, standardised and secured IT-enabled repository of India's healthcare resources, Nadda said. NHRR will be the ultimate platform for comprehensive information of both private and public healthcare establishments including Railways, ESIC, Defence and Petroleum heath establishments. The Central Bureau of Health Intelligence (CBHI) has actively engaged with key stakeholders including leading associations, allied ministries, and several private healthcare service providers to frame the facility. "This resource repository shall enable advanced research towards ongoing and forthcoming healthcare challenges arising from other determinants of health like - disease, environment etc," Nadda said. Approximately 4,000 trained professionals are working to approach every healthcare establishment for information collection. The Indian Space Research Organisation (ISRO) is the project technology partner adhering to paramount data security. Under the Collection of Statistics Act 2008, over 20 lakh hospitals, clinics, diagnostic labs, pharmacies and nursing homes would be enumerated under this census capturing data on over 1,400 variables. "Additionally, it shall generate real-world intelligence to identify gaps in health and service ratios, and ensure judicious health resource allocation and management. It shall identify key areas of improvement by upgrading existing health facilities or establishing new health facilities keeping in view the population density, geographic nature, health condition, distance, etc," Nadda said. Nadda also released the National Health Profile (NHP)2018, prepared by the Central Bureau of Health Intelligence (CBHI), here today. The National Health Profile covers demographic, socio-economic, health status and health finance indicators, along with comprehensive information on health infrastructure and human resources in health. Nadda stated that the health profile is a very important tool as it has helped in designing various programmes. ]]> https://biospectrumindia.com/news/22/11141/mtai-lauds-niti-aayog-on-tmr-asking-a-non-discriminatory-approach.html https://biospectrumindia.com/news/22/11141/mtai-lauds-niti-aayog-on-tmr-asking-a-non-discriminatory-approach.html Tue, 19 Jun 2018 15:15:00 +0530 Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies with significant manufacturing investments in India, has commended NITI Aayog for floating a concept note on the much-awaited trade margin rationalization and committed to provide all support in forming a balanced policy on the subject.“We laud the inclusive approach and continual efforts of the government to rationalize the trade margins. MTaI has been actively involved in deliberations with the government on bringing down the cost of medical treatment for patients. We had expressed our support to trade margin rationalisation as suggested in Report of The Committee on High Trade Margins in the Sale of Drugs, 2016 as early as August 2017. We believe it is an effective alternative to price capping.“We have seen its adoption in Delhi Government’s draft policy to control trade margins. We continue to be committed to a balanced policy at the level of the union government,” the association said in a press release.“Taking advantage of the government’s concerns on ‘profiteering’ in healthcare, a great deal of misinformation is being spread about subsidiaries of MNC device manufacturers regardless of their track record. The fact that these subsidiaries are adding value to the supply chain is being pushed under the carpet through the falsity of these claims,” MTaI said.MTaI members perform a lot of value-added services in India which help in introduction of innovative technologies for improved clinical outcomes for patients. The value-added services include the following:  In-clinic support through trained clinical experts. Proctor support of expert healthcare professionals in new therapies. Therapy awareness programs among healthcare professionals in primary healthcare centres. Skill development of clinicians in new technologies, through product training. Continuous Medical Educational Programs ( CME ) and clinical research. Maintain the global quality standards of the products by ensuing apt storage facility Necessary equipment supports to use disposables. Servicing of the equipment. After sales support to customers. Generation of employment for professionals from marketing, sales, clinical experts, regulatory, quality, logistics, financial technical, engineering fields. “More than 75% of medical devices and more than 85% of critical care medical devices are currently imported and sold by MNC subsidiaries after the above mentioned value additions. Considering this, any regulation needs to be non-discriminatory in its approach as far as treatment of these companies vis-à-vis indigenous companies is concerned. We expect NITI Aayog to see through the false claims and consider our views in earnest. This will also act as an enabling factor for Aayushman Bharat by ensuring the uninterrupted supply of vitally important critical care devices” the association said.MTaI said that calculation of trade margin should consider the Price to Trade as suggested in Report of The Committee on High Trade Margins in the Sale of Drugs, 2016 and not the landed cost, as the latter is the prelude to a lot of other expenditures incurred by importers on training the value chain as mentioned above. On the other hand, Price to Trade criterion takes into account all relevant expenditures.“Toward this, we support the formula of ‘MRP = Price at the First Point of Sale (distributor) + % age of Trade Margins’. We believe a level-playing field will emerge from this criterion while reducing the MRPs substantially. Using data mentioned in the NPPA report on MRPs of medical devices sold by a leading hospital, issued earlier this year, and assuming a reasonable trade margin of 50% we have seen that this formula will result in a reduction of as much as 73% in MRP,” it added. The association has submitted its response to NITI Aayog.“Landed cost approach to trade margin calculation is retrogressive and doesn’t incentivize efficiency. Landed cost depends on Transfer Price. As the name suggests, Transfer Price is the price at which the devices are transferred internally between the parent company to its subsidiary and hence is not comparable with the Price to Distributor, which is the market price,” MTaI said.“Also, if we set the norm of using landed cost for trade margin determination, not only will the imports of life saving drugs and devices will suffer but the indigenous industry’s exports of drugs and devices will be severely affected as other countries importing Indian drugs and devices are likely to start using the same methodology for determining the selling price there. Moreover, cost-based approach has long been discarded by National Pharmaceutical Pricing Policy (NPPP) 2012 as it thwarts the industry’s ability for capacity building and innovation,” it added. ]]> https://biospectrumindia.com/news/22/11136/assam-govt-tata-trusts-operationalise-cancer-care-foundation.html https://biospectrumindia.com/news/22/11136/assam-govt-tata-trusts-operationalise-cancer-care-foundation.html Mon, 18 Jun 2018 13:55:00 +0530 The Government of Assam and the Tata Trusts has set forth on their joint initiative of establishing a comprehensive cancer care network in the state, with Mr. Sarbananda Sonowal, the Chief Minister of Assam, Mr. Amit Shah, Member of Parliament, Rajya Sabha, Dr. Himanta Biswa Sarma, the Health Minister of Assam, and Mr. Ratan N. Tata, Chairman of the Tata Trusts, together unveiling the foundation stones of 19 modern cancer care facilities that will dot the state. The Government of Assam and the Trusts have set up the Assam Cancer Care Foundation, dedicated to this initiative.   Of these 19 facilities, 12 will be comprehensive cancer care centres on the premises of Government Medical Colleges in the state. Located at Barpeta, Dhubri, Diphu, Jorhat, Karimganj, Kokrajhar, Lakhimpur, Nagaon, Nalbari, Silchar, Tezpur, and Tinsukia they will offer diagnosis and treatment of cancer cases. Another five will be adjacent to District Hospitals. Located at Darrang, Goalpara, Golaghat, Haflong, and Sivasagar, they will offer diagnostic and day care services, including chemotherapy. Assam Medical College, Dibrugarh, will be upgraded to an apex cancer centre with education and public health research capabilities. The State Cancer Institute (SCI) in Guwahati will be expanded to a 500-bed South Asia Research Centre.    This network will become operational beginning April 2019. It is designed to ensure that no patient has to travel more than a few hours for accessing full suite of cancer treatment within the public system so that care is affordable. The facilities have been designed to maximise patient comfort as they have to spend prolonged periods in the hospital. The facilities will be equipped with appropriate technology and task shifting tools so that the network virtually becomes one.   The Digital Nerve Centre (DiNC) set up at SCI and will enable this virtual unification across the State. It will help guide patients from the community to the apex level so that appropriate referral mechanisms and appointment systems are followed. It will also provide tele-health and virtual tumour board services at all network facilities so that any apex facility nationally can be consulted easily. This will eventually lead to an enhanced patient experience by ensuring that patients and caregivers do not spend time at hospitals because of lack of information regarding the treatment process. Mr. Tata and Dr. Himanta Biswa Sarma inaugurated the DiNC yesterday.   Government of India designed awareness, screening, early detection, and palliative care programmes will be implemented through the Assam Cancer Care Foundation. This will be critical in ensuring that patients come forward for treatment at the first sign of symptoms. It is envisaged that after the network becomes operational and the programmes are fully implemented the shift from late stage to early stage detection will be evident within a three-year period.  Dr. Sarma announced at the unveiling ceremony that cancer will be made a notifiable disease starting September 2018 in the State so that all patients are able to access care through the public healthcare network on the backbone of the DiNC. Once cancer is made a notifiable disease all practitioners will have to report any cancer case detected to the Health & Family Welfare Department of the State by filling basic information regarding the patient online.   Speaking on the occasion, Mr. Sarbanada Sonowal said, “The aim of this great initiative jointly undertaken by the Government of Assam in association with the Tata Trusts is to provide cancer care to marginalised sections of society and bring them some hope. I am very glad that the Tata Trusts have fulfilled their commitment by implementing this initiative as promised. I offer my sincere gratitude to Mr. Ratan Tata on behalf of the people of Assam for his great and philanthropist initiative for the state and the entire North - Eastern region. This initiative will benefit the people across this region, especially those who are marginalised.”   Mr. Ratan N. Tata said, “Cancer care in India is hindered by the lack of facilities, late diagnosis, and high cost of treatment. The Tata Trusts have resolved to tackle this by supporting the establishment of infrastructure across the country for high quality affordable care, and nation-wide screening and early detection programmes. Together with partners if we can achieve this, India will be able to dramatically increase survival rates, as in the developed countries. I am happy that we are able to join hands with the Government of Assam to achieve this transformation in the state and the region.”   The Government of Assam has made healthcare a top priority and has launched several initiatives in universalising cancer care, such as the establishment of the State Cancer Institute in Guwahati, provision of free diagnostics at District Hospitals, and the introduction of the Atal Amrit Abhiyan scheme which covers a large range of oncology services and almost 90% of the State’s population. The network of Government Medical Colleges has also been expanding rapidly in the last few years. The proposed infrastructure will therefore be a platform to utilise these schemes.   The Trusts are currently in conversation with various other State Governments, like Andhra Pradesh, Odisha, and Telangana, for establishing similar networks. Over the next three years, about 100 such centres are expected to be added. ]]> https://biospectrumindia.com/news/22/11124/20-states-sign-mou-for-implementing-ab-nhpm.html https://biospectrumindia.com/news/22/11124/20-states-sign-mou-for-implementing-ab-nhpm.html Fri, 15 Jun 2018 10:50:00 +0530 J P Nadda, Union Minister of Health and Family Welfare exchanged the Memorandum of Understanding (MoU) with the State Health Ministers of 20 States marking their commitment towards the launch of the Ayushman Bharat – National Health Protection Mission (AB-NHPM) at a Health Ministers conclave, in New Delhi recently. Ashwini Kumar Choubey and Anupriya Patel, Ministers of State for Health and Family Welfare, Amitabh Kant, CEO NITI Aayog, Dr. Vinod Paul, Member Health, NITI Aayog, Preeti Sudan, Secretary (Health) and Indu Bhushan, CEO, AB-NHPM, were also were also present at the function. “We shall work together, learn together, so that we work with the spirit of cooperative federalism, to perfect this largest health assurance scheme of the world,” Nadda said. Nadda emphasized that the success of the scheme hinges upon the active participation of the States. States need to own the scheme while Centre will design the policy framework with all possible flexibility and support. “Exchanging of Memorandum of Understanding is an important step in formalizing the partnership between Centre and States,” he added. Nadda further stated that AB-NHPM will protect around 50 crore people (from about 10 crore families). “It will be cashless and paperless access to services upto Rs. 5 lakhs per year will be available for the beneficiary families at the point of service in both public and private empanelled hospitals across India,” Shri Nadda added. He further said that the beneficiaries under the scheme can avail services anywhere in India and it is expected to bring a visible relief to the target families by mitigating the financial risk arising out of catastrophic health episodes. The Union Health Minister further stated that health is at the centre-stage and the Government is looking at it holistically. He said that AB-NHPM will protect the people and at the same time Health and Wellness Centres (HWCs) will deliver comprehensive primary health care. “The H&WC would provide preventive, promotive, and curative care for non-communicable diseases, dental, mental, geriatric care, palliative care, etc. He further stated that the Government has initiated universal screening of common NCDs such as diabetes, hypertension and common cancers along with Tuberculosis and Leprosy, which will eventually help in reducing the disease burden of the country. Ashwini Kumar Choubey, Minister of State for Health and Family Welfare, said that Ayushman Bharat - National Health Protection Mission (AB-NHPM) will have major impact on reduction of Out Of Pocket (OOP) expenditure. Choubey further said that the scheme will give cashless benefits in any public or private hospital across the country, ensuring accessible and equitable quality health care to the marginalized and vulnerable sections. Anupriya Patel, Minister of State for Health and Family Welfare stated that NHPM is a move towards comprehensive model of health services delivery, from a sectoral, fragmented and segmented approach. She further said that it a big step to improve secondary and tertiary hospitalization and healthcare facilities. The Health Ministers and Secretaries were appreciative of the support and inclusive approach extended by the Ministry of Health and Family Welfare and National Health Agency for Ayushman Bharat – National Health Mission (AB-NHPM) with substantial engagement of all the stakeholders while firming up all the aspects of the Mission like operational guidelines, model tender document for selection of insurance companies and implementation support agencies for trusts, etc CEO AB-NHPM, Indu Bhushan gave a detailed presentation and updated the status of the implementation. He urged the States to seek approval and release RFP for insurance company hiring (in case of insurance mode) or Implementation support agency (ISA) in case of trust mode implementation. 20 states have so far signed MoU and its likely to be 25 States by the end of this month. During the conclave, model tender documents, final operational guidelines for AB-NHPM were released which are focused on beneficiary centric delivery of services while ensuring there is no compromise on the quality of healthcare services and preventing frauds. The participants were appreciative of the inclusive approach taken by National Health Agency during consultations and workshops. A web portal for initiating the empanelment of hospitals under the mission was also launched. This marks the commencement of the implementation of AB-NHPM and takes the Mission closer to launch. Training / Demo of empanelment software will be conducted in next two weeks and States can operationalize empanelment of hospitals by 1st of July. ]]> https://biospectrumindia.com/news/22/11119/cabinet-apprised-of-health-pact-signed-between-india-france-.html https://biospectrumindia.com/news/22/11119/cabinet-apprised-of-health-pact-signed-between-india-france-.html Thu, 14 Jun 2018 14:15:00 +0530 The Union Cabinet was apprised about a pact signed between two health bodies of India and France, which aims at cooperation in medical, life sciences and health research sectors including diabetes and metabolic disorders. The pact also aims at cooperation in bio-ethics with focus on ethics and regulatory issues of gene editing techniques and rare diseases. "The Union Cabinet chaired by Prime Minister Narendra Modi has been apprised of an MoU which was signed in March, 2018 between the Indian Council of Medical Research (ICMR) and the Institut National de la Santeet de la RechercheMedicale (INSERM), France," an official statement said. The MoU will further strengthen relations between ICMR and INSERM within the framework of international scientific and technological cooperation in fields of mutual interest, it said. "The MoU aims at cooperation in areas of common interest within the medical, life sciences and health research fields. Based on scientific excellence on both sides, the parties have agreed to have a specific focus upon: Diabetes and metabolic disorders, bio-ethics with focus on ethics and regulatory issues of gene editing techniques, rare diseases and any other areas of mutual interest can be considered after discussions between the two sides," it said. The scientific excellence on two sides will help to successfully work on health research in specified areas, it added. ]]> https://biospectrumindia.com/news/22/11109/indias-most-ambitious-health-insurance-scheme-could-face-delays-due-to-tech-glitches.html https://biospectrumindia.com/news/22/11109/indias-most-ambitious-health-insurance-scheme-could-face-delays-due-to-tech-glitches.html Tue, 12 Jun 2018 18:55:00 +0530 The central government is working at full throttle to launch Ayushman Bharat, India’s most ambitious health insurance scheme yet, but it is possible that the rollout may be delayed owing to tech glitches. Health minister JP Nadda has said that until the IT backbone of Ayushman Bharat is fully tested and stable, the scheme will not launch. He did not provide a date for the launch but said that glitches will be ironed out before it is green lighted. This could mean that the earlier deadline of August 15 may have to be pushed back and the plan may only be ready by October 2, Gandhi Jayanti, reported media agencies. Ayushman Bharat envisages a Rs 5 lakh annual insurance cover at no cost to four in ten Indians, with the Centre and state governments picking up the tab. The scheme requires states to sign individual MoUs with the central government to implement it but even after that has happened, a robust IT system needs to be in place. A glitch proof IT backbone will help insurance companies administer claims etc on a real-time basis. The IT network will connect insurance companies, specific state health agencies and third-party administrators. Remember, a key feature of Ayushman Bharat is portability and a robust IT network is crucial for this to function. Nadda said 80% of the beneficiaries under this scheme have already been identified in rural areas and work was on to similarly identify beneficiaries in urban areas. A senior government official had earlier said that the government has allocated Rs 4,000 crore for Ayushman Bharat until now, of the Rs 10,000 crore that the scheme is supposed to get in 2018-19. Since states are expected to bear 40% of the scheme’s burden, the remaining Rs 2,000 crore of the central government’s share should come in the supplementary demand for grants, which will be presented later in the fiscal year. As of now, MoUs with eight states have been signed and another 12 states are expected on come on board by June 14. Some state governments are using the ‘Trust’ model for implementing Ayushman Bharat while others are doing it directly. In the trust model, the state government fixes prices, there is no price discovery and this model is considered ideal for health insurance as a non-profit motive is assured. Meanwhile, the earlier health insurance scheme ‘Rashtriya Swasthya Bima Yojana’ only offered Rs 30,000 annual cover and covered only about a third of the universe compared to the coverage universe of the Ayushman Bharat scheme. RSBY will anyway be subsumed in Ayushman Bharat.   ]]> https://biospectrumindia.com/news/22/11107/china-to-conduct-training-programmes-for-indian-pharma-companies.html https://biospectrumindia.com/news/22/11107/china-to-conduct-training-programmes-for-indian-pharma-companies.html Tue, 12 Jun 2018 18:30:00 +0530 China has agreed to conduct specific training programmes for domestic pharmaceutical companies to understand their regulatory system, which will promote India's exports from the sector, a senior government official said.  The move assumes significance as it takes years for Indian pharmaceutical companies to obtain regulatory clearances for their products in China.  "China has assured us that they would provide a platform for Indian exports of pharmaceutical products and would also impart specific training to our companies to understand the Chinese regulatory system and processes," the official said.  India has time and again made strong pitch to push its pharma exports in the neighbouring country. On the other hand, India imports about 60 per cent of its requirement of raw material for the sector from China.  India's import of active pharmaceutical ingredients (API) from China stood at Rs 12,254.97 crore in 2016-17.  India's pharmaceutical exports increased by about 3 per cent to USD 7.27 billion in 2017-18. However, the exports to China stood at USD 182.67 million in 2017-18 only.  Increasing exports to China would help bridge the widening trade deficit, which has increased to USD 63.12 billion in 2017-18 from USD 51.08 billion in the previous fiscal.  ]]> https://biospectrumindia.com/news/22/11105/usfda-approves-wearable-device-to-treat-drug-addiction.html https://biospectrumindia.com/news/22/11105/usfda-approves-wearable-device-to-treat-drug-addiction.html Tue, 12 Jun 2018 13:15:00 +0530 The U.S. Food and Drug Administration have cleared an auricular neurostimulation device manufactured by a Chennai company to treat the symptoms of opioid withdrawal without narcotics. The device, Drug Relief®, is made by DyAnsys India for its U.S. affiliate, DyAnsys Inc.   Drug Relief® is available by prescription for use during opioid detoxification. This wearable device sends electrical pulses through tiny needles inserted in the ear to alleviate symptoms such as anxiety, agitation, depression, nausea, opiate cravings and more.   "This device offers hope to those who are suffering from opioid addiction," said DyAnsys Chief Executive Officer Srini Nageshwar, a graduate of the Institute of Technology Madras. "We are in a full-blown crisis and we need non-narcotic options and alternatives like this that can make a significant difference for individual patients and their families."   Drug Relief® is a percutaneous electrical nerve field stimulator designed to administer auricular neurostimulation treatment over 120 hours.   The non-addictive treatment allows for continuous nerve stimulation for five days while offering the patient a high degree of comfort and mobility.   According to providers, patients may see a reduction in symptoms within 30 to 60 minutes of beginning treatment.   The device eases detoxification, the first step in a comprehensive rehabilitation program. The objective is to relieve symptoms while opioids are cleared from a patient's system.   It can be used to stabilize a patient during the early stages of withdrawal without side effects. Stabilization necessary before treating the patient with medication-assisted therapies. ]]> https://biospectrumindia.com/news/22/11094/nipah-update-union-minister-declares-that-nipah-virus-has-been-contained.html https://biospectrumindia.com/news/22/11094/nipah-update-union-minister-declares-that-nipah-virus-has-been-contained.html Mon, 11 Jun 2018 12:25:00 +0530 Kerala Health Minister KK Shailaja has said that the deadly Nipah virus that struck Kozhikode has been finally contained and the last of the two positive cases have fully recovered. Union Minister of State for Health, Ashwini Choubey, said that the Nipah virus has been contained and there was no need to run away from Kerala, where several deaths due to the virus have been reported. He added that no fresh cases of infection have been reported. "There have been no new cases of Nipah reported from anywhere in the country. The virus has been stalled. This is a good sign. Nipah is not epidemic and there is nothing to be scared of," Mr Choubey told PTI. Mr Choubey is in the Kolkata for official meetings with several health institutions, besides state ministers. On reports of several people returning from Kerala to West Bengal fearing the virus, he said, "Our entire team is in place. The virus has been contained even in Kerala. There is no need to run away from anywhere." Nipah virus has not led to any deaths in West Bengal. Mr Choubey said that people who lost family members because of the Nipah virus, have been treated in isolation and were totally out of danger. "We have treated the family of those persons who were infected by and died because of Nipah virus. They were kept in isolation in Pune's National Institute of Virology," the minister added. "As per the latest report of the Central High Level Team, Nipah Virus is not a major outbreak and its occurrence is limited to two districts Kozhikode and Malappuram in Kerala," an advisory issued by the National Centre for Disease Control said. "There is no need for the general public to be apprehensive about the safety of their family members. The Ministry of Health and Family Welfare is closely monitoring the situation," the department under the Health Ministry added. The Kerala government has advised travelers to avoid visiting the four districts of Kozhikode, Malappuram, Wayanad and Kannur as a precautionary measure. ]]> https://biospectrumindia.com/news/22/11088/indias-maternal-mortality-ratio-has-declined-to-130.html https://biospectrumindia.com/news/22/11088/indias-maternal-mortality-ratio-has-declined-to-130.html Fri, 08 Jun 2018 18:25:00 +0530 The Maternal Mortality Ratio (MMR) in India has declined from 167 in 2011-2013 to 130 in 2014-2016, according to a special bulletin issued by the Health Ministry today. MMR is defined as the proportion of maternal deaths per 1,00,000 live births. The decline has been most significant in Empowered Action Group (EAG) states and Assam, from 246 to 188, it said. The Special Bulletin of Maternal Mortality in India stated that among the southern states, the decline has been from 93 to 77 and in "other" states from 115 to 93. "The latest SRS figures reveal that we have gone beyond the MDG target of Maternal Mortality Ratio (MMR) of 139 by 2015 & have reached 130!! I congratulate the Ministry, @MoHFW_India and the states for their joint efforts," Union Health Minister J P Nadda said on Twitter. The bulletin was released under Sample Registration System (SRS). To understand the maternal mortality situation in the country better and to map the changes that have taken place, especially at the regional level, the government has categorised states into three groups -- EAG, southern states and "other" states. EAG states comprise Bihar, Jharkhand, Madhya Pradesh, Chhattisgarh, Odisha, Rajasthan, Uttar Pradesh and Uttarakhand, and Assam. The southern states are Andhra Pradesh, Telangana, Karnataka, Kerala and Tamil Nadu and the "other" states categories cover the remaining states and Union territories. The first report on maternal mortality in India (1997-2003), describing trends, causes and risk factors, was released in October, 2006. The present bulletin, which provides only the levels of maternal mortality for the period 2014-16, is being brought out as a sequel to the previous bulletin (2011-13). The survey for the current bulletin covered 62,96,101 pregnant women out of which 556 died. Maternal death or maternal mortality is defined by the World Health Organization (WHO) as "the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes." ]]> https://biospectrumindia.com/news/22/11085/health-ministry-launches-smoking-cessation-campaign.html https://biospectrumindia.com/news/22/11085/health-ministry-launches-smoking-cessation-campaign.html Fri, 08 Jun 2018 12:15:00 +0530 At a World Health Organization (WHO) event recently, the Ministry of Health and Family Welfare, Government of India launched a national media campaign to encourage smoking cessation. Entitled “What Damage Will This Cigarette/Bidi Do,” the public service announcement (PSA) prompts smokers to think about each cigarette or bidi as the path to one of many potential harmful events: heart attacks, cancer, lung disease, and more. By highlighting tobacco’s links to stroke and heart disease, the leading cause of death among tobacco users globally, the campaign amplifies the theme of this year’s World No Tobacco Day, which is “Tobacco Breaks Hearts.” Vital Strategies provided technical support for the development and implementation of this campaign. Dr. Nandita Murukutla, Vice President, Global Policy and Research, Vital Strategies, said, “We congratulate the Ministry of Health on this powerful campaign. According to the latest Global Adult Tobacco Survey, more than 90 percent of current adult smokers are aware that smoking and exposure to second hand smoke causes serious illness. This campaign graphically shows the specific, proven harms of tobacco smoke, prompting smokers to think about making the healthy choice to quit. Vital Strategies is pleased to partner with the Ministry of Health in delivering this campaign.” Ashwini Kumar Choubey, Minister of State for Health and Family Welfare said, “We should have an addiction-free India that includes Tobacco-free India. He made an appeal for “NashaMuktiAbhiyaan”. He further added that we need community mobilization to encourage people to give up tobacco consumption. “Tobacco destroys families and communities. We need to start a nationwide abhiyaan- people’s movement, to combat tobacco use.” “What Damage Will This Cigarette/Bidi Do” shows that smoking causes stroke, lung and mouth cancer, heart disease and emphysema, among other diseases. It encourages smokers to quit tobacco use and ends with the national quit line number (1800-11-2356) and a missed call number (011-22901701) for smokers who want advice on quitting. The campaign will achieve pan-India reach by being broadcast in 17 languages on all major national government and private TV and radio channels. In addition, the campaign will be supported by a comprehensive social media campaign and will run on major digital platforms including Youtube, Facebook, Hotstar and Voot.  According to The Tobacco Atlas, more than 9 lakh Indians die due to tobacco-related diseases every year. Research suggests that implementing strong tobacco control measures to reduce tobacco use could avert 25 percent of cases of heart attack and stroke in India. Strong tobacco control would also help to reduce the incidence of cancer in India: nearly 45% of all cancers among males, 17% among females and more than 80% of oral cancers are directly attributable to tobacco use. “What Damage Will This Cigarette/Bidi Do” was rigorously pretested with a sample of the target audience who found that it was ‘easy to understand’, ‘believable’, ‘made respondents stop and think’, and ‘made respondents feel more concerned’ about smoking and diseases related to it. Overall, respondents understood the main message of the PSA and it resonated well with them. ]]> https://biospectrumindia.com/news/22/11080/health-ministry-to-accelerate-tobacco-control-measures.html https://biospectrumindia.com/news/22/11080/health-ministry-to-accelerate-tobacco-control-measures.html Wed, 06 Jun 2018 23:40:00 +0530 Ashwini Kumar Choubey, Minister of State for Health and Family Welfare inaugurated the two-day National Consultation on Accelerating Implementation of Tobacco Control Measures for achievement of Goals under National Health Policy, 2017 in presence of Anupriya Patel, Minister of State for Health and Family Welfare to commemorate the World No Tobacco Day, 2018. Preeti Sudan, Secretary (Health), Sanjeeva Kumar, Additional Secretary and Promila Gupta, DGHS, Ms Payden, Acting Deputy WHO representative to India were also present at the occasion. Addressing the participants, Ashwini Kumar Choubey said that we should have an addiction-free India that includes Tobacco-free India. He made an appeal for “NashaMuktiAbhiyaan”. He further added that we need community mobilization to encourage people to give up tobacco consumption. “Tobacco destroys families and communities. We need to start a nationwide abhiyaan- people’s movement, to combat tobacco use”, he said. Choubey also made a strong call for accelerating tobacco control measures for achievement of the goals under National Health Policy, 2017. He observed that tobacco use is a leading cause of premature, NCD-associated mortality and morbidity, and a growing public health challenge. He further said that while many people are aware tobacco use increases the risk of cancer, there are alarming gaps in knowledge of the cardiovascular risks of tobacco use. “I look forward to the suggestions that will emerge from the two-day national consultation, to help us move forward in tobacco control measures”, Choubey elaborated. Anupriya Patel said that tobacco epidemic is a major public health challenge in India, and flavored smokeless tobacco usage in India is very high. She stated that concerted strong political commitment and targeted action over the last decade have contributed to commendable achievements in pushing back the tobacco epidemic. Highlighting the initiatives of the Health Ministry, Anupriya Patel said that a toll free Tobacco Cessation Quitline has been set up and m-Cessation services under the Be Healthy Be Mobile Initiative has been launched along with the Helpline for reporting specific violations of tobacco control laws. She stated that the large specified health warnings occupying 85% of the principal display areason both the sides of the packs have been implemented. “With the inclusion of National tobacco Quitline number in the health warning recently, it has been made more impactful. This will give tobacco users access to counseling services to effect behavior change,” Anupriya Patel added. She noted that we need to be alert to the threat of new and emerging products and to act swiftly and firmly against them. “We can win the battle only through synergy of our efforts, both within and beyond country,” she said. The Ministers of State released the Global Adult Tobacco Survey 2 India Report, 2016-17 and guidelines for establishing tobacco cessation centres in dental colleges at the consultation and felicitated tobacco workers who have transitioned to other livelihood options. Tobacco survivors presented first-hand account of their struggles and their efforts to overcome the challenges. The two-day consultation will focuson capacity-building of the National Tobacco Control Progamme Nodal Officers. Among the key areas of deliberation will be multi-sectoral engagement for implementation of WHO FCTC in India and synergizing tobacco control with new health initiatives.Tobacco is responsible for 4.5 lakh CardioVascularDiseases (CVD) deaths in the country. In 2011, the total economic cost attributable to tobacco use from all diseases in India for persons aged 35-69 years amounted to a staggering Rs. 1,04,500 crores ($22.4 billion). ]]> https://biospectrumindia.com/news/22/11074/health-ministry-denies-renewal-permission-to-82-medical-colleges.html https://biospectrumindia.com/news/22/11074/health-ministry-denies-renewal-permission-to-82-medical-colleges.html Wed, 06 Jun 2018 15:25:00 +0530 The Union health ministry has denied 82 existing medical colleges renewal permission for the academic session of 2018-19. The ministry has stopped 12 government and 70 private medical colleges from taking in new students for the upcoming batch, blocking anywhere between 10,000 to 12,000 MBBS seats. The government has also denied permission for the establishment of 68 new medical colleges, 31 government and 37 private, axing another potential 9000 MBBS seats. Nine medical colleges, four government and five private, were stopped from expanding their seats by at least 50 seats each. 31 medical colleges were barred from either starting new super speciality courses, such as those in cardiology, nephrology, plastic surgery, etc. or expanding seats in existing courses. The list included Lucknow's King George Medical College University, stopped from expanding or starting MCh (Plastic & Reconstructive Surgery) and MCh (Neurosurgery), Christian Medical College Vellore, disallowed courses in MCh (Reproductive Medicine& Surgery), DM (Nephrology), DM (Pediatrics Neurology), Institute of Liver & Billiary Sciences, New Delhi, disallowed DM (Hepatology), MCh (HPB Surgery) and DM (Pediatrics Hepatology), etc. The decisions came after assessment by the Medical Council of India, the apex government body in charge of medical education and ethics. The loss of seats is bound to hit the lakhs of aspiring medical students, already fighting for seats that are not nearly enough in number to accommodate all of them. ]]> https://biospectrumindia.com/news/22/11057/health-ministry-highlights-mental-healthcare-2017.html https://biospectrumindia.com/news/22/11057/health-ministry-highlights-mental-healthcare-2017.html Mon, 04 Jun 2018 12:55:00 +0530  Attempting suicide is no more a crime in India and there will be no more electric shocks for mentally ill children, as per the new Mental Healthcare Act 2017 notified by the Health Ministry on May 29, a year after it was passed. “Notwithstanding anything contained in Section 309 of the Indian Penal Code, any person who attempts to commit suicide shall be presumed, unless proved otherwise, to have severe stress and shall not be tried and punished under the said Code,” says the Act. According to news agencies, as per the Act, the government will have the duty to provide care, treatment and rehabilitation to the person, who attempts suicide and has severe stress, to reduce the risk of recurrence of attempt to commit suicide. The 2017 Act, which clearly defines mental illness, replaced the Mental Health Act 1987. Aimed at transforming the mental healthcare regime in the country, it is enacted to harmonize India’s laws with the Convention on Rights of Persons with Disabilities and its Optional Protocol. The treatment and rehabilitation cost for persons with mental illness living below the poverty line, even without the possession of a BPL card, or those who are homeless would be free of any charge at all mental health establishments run or funded by the appropriate government, reported IANS. ]]> https://biospectrumindia.com/news/22/11054/new-clinical-trial-rules-to-be-final-in-two-months.html https://biospectrumindia.com/news/22/11054/new-clinical-trial-rules-to-be-final-in-two-months.html Fri, 01 Jun 2018 16:00:00 +0530 India’s drug regulator plans to finalize new rules for clinical trials in a couple of months that would shorten the review time, reported Reuters, aiming to boost clinical research in the country after interest in recent years waned. The country’s 1.2 billion people and large burden of diseases make for an attractive patient pool for global pharmaceutical companies looking to test new drugs, but stringent rules in the last few years have caused some companies to move their research work to other countries. New rules drafted by India’s Central Drug Standard Control Organization (CDSCO) aim to change that, reducing the approval time for review of applications to between 30 and 60 days, Ranga Chandrashekhar, a deputy drugs controller at the CDSCO said on the sidelines of a pharmaceutical conference in Mumbai. “We have already received comment from stakeholders on our draft, and it should be finalised in about two months,” Chandrashekhar said. The draft was uploaded on the agency’s website in February. If finalised, it would go to the country’s health ministry for approval before being published, he added. The agency tightened rules for clinical research a few years ago after cases emerged of some patients being enrolled into trials without informed consent, and not being adequately compensated. The new rules would let the ‘ethics committees’ – groups of medical experts – that oversee clinical trials decide on the level of compensation for patients who suffer adverse events, Chandrashekhar said. Tougher compensation rules could turn the industry away from conducting trials at a time when companies have been gradually looking back to India for clinical work, warned D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, which represents large Indian drugmakers. “There has been some revival (of clinical research) based on some assurances given by the government and simplifications (of rules),” Shah said. But if compensation rules are adopted as mentioned in the draft released by the CDSCO, companies “will run away from here,” he said. “This is not conducive to doing innovation and research in India,” Shah said. As part of overhauling drug regulations in the country, the CDSCO is also planning to bring in new rules for the sale of over-the-counter drugs, and e-pharmacies in the coming months, Chandrashekhar said.   ]]> https://biospectrumindia.com/news/22/11053/india-seeks-australias-help-to-combat-nipah-virus.html https://biospectrumindia.com/news/22/11053/india-seeks-australias-help-to-combat-nipah-virus.html Fri, 01 Jun 2018 15:40:00 +0530 In the wake of Nipah virus cases in Kerala, the Indian Council for Medical Research (ICMR) has written to the Queensland government in Australia asking it to provide an antibody developed there to test if it can "neutralise" the virus in humans. The antibody has not been tested on humans so far. "We have asked them to give their monoclonal antibody for conducting a test in India to find out if it can neutralise the Nipah virus in humans.  "In Australia, it has only been tried in vitro (happening outside the body in artificial conditions, often in a test tube) and has been found to be effective. But it has not been tested on humans," said ICMR Director General, Dr Balram Bhargava, while clarifying that it will not lead to creation of vaccine. ICMR is the apex body in India for the formulation, coordination and promotion of biomedical research. "We are preparing a dossier on what will be methodology and what would be the regulatory process so that we can fast track the process," he said. According to Dr Bhargava, Australia is ready to share as it will help generate data on the efficacy of the antibody.  "It is not yet sure how much it will be effective," he said, adding the infection caused by Nipah virus has a high mortality rate (50-70 pc). According to National Vector Borne Disease Control Programme, the drug ribavirin has been shown to be effective against the viruses in vitro, but human investigations to date have been inconclusive and the clinical usefulness of the drug remains uncertain. The death toll due to outbreak of Nipah virus rose to 12 in the southern state of Kerala, with one more person succumbing to the deadly virus in Kozhikode this morning, said a Health ministry official. Meanwhile, there are reports of dead bats being found on the premises of a government school in Himachal Pradesh, samples of which have been sent for testing to NIV, Pune, to ascertain the reason behind their deaths.  According to the health ministry officials, of the 12 deaths in Kerala so far due to the virus, nine people died in Kozhikode district and three in Mallappuram. Besides, about 160 samples have been sent for testing at the virology institute. While 18 people with specific symptoms are admitted at hospitals in Kozhikode, 22 patients with suspected Nipah cases, all from Malappuram district, are admitted at Kozhikode Medical College for observation. "They are all contacts of the confirmed cases and their lab results are awaited. Also, 95 families are under surveillance," a health ministry official said. Nipah virus (NiV) infection is a newly emerging zoonosis that causes severe disease in both animals and humans. The natural host of the virus are fruit bats of the Pteropodidae Family, Pteropus genus.  Currently, there is no vaccine or drug for the treatment of the NiV infection. The treatment for human cases is supportive and management treatment along with intensive supportive care. The virus spreads through close contact with people's secretions and excretions. Eating food which may have the droplets of saliva and urine of infected bats can lead to the transmission of the virus.  Earlier, cases of Nipah virus were reported from Siliguri in 2001 and Nadia in 2007 in West Bengal and around 47 deaths were reported. ]]> https://biospectrumindia.com/news/22/11051/health-ministry-plans-a-law-to-shield-health-data-of-citizens-.html https://biospectrumindia.com/news/22/11051/health-ministry-plans-a-law-to-shield-health-data-of-citizens-.html Fri, 01 Jun 2018 12:45:00 +0530 India’s health ministry has proposed a law to govern data security in the healthcare sector that would give individuals complete ownership of their health data. Individuals would have the absolute right to refuse or allow data to be generated, collected, accessed, transmitted or used. Data collectors such as hospitals would be prohibited from refusing treatment to those who do not want their data collected or used. This would make India one of the world’s foremost jurisdictions in the regulation of healthcare data, at a time when governments around the world are scrambling to keep a check on who gets to generate and use data and how, especially as citizens do not completely understand the data privacy and security implications of the innumerable applications they wittingly or unwittingly use. The draft Digital Information Security in Healthcare Act was proposed by the health ministry on March 11, 2018. The period for stakeholder comment ended April 21 and a bill is currently being finalized. Experts say the health ministry is possibly waiting for a final verdict from the Supreme Court on petitions challenging the constitutional validity of Aadhaar–on which it has just completed the second-longest oral hearing in the history of the court. The ruling is expected in July or August. The verdict will guide India’s data privacy framework, which is already being prepared by the Committee of Experts on a Data Protection Framework for India being chaired by Justice BN Srikrishna. It will also have implications for the health ministry’s proposed law. The responsibility for ensuring data security and privacy would lie with the entity that has custody of the data, which could be penalized for data breach. Currently, under Indian law, companies in India are not obligated to inform individuals of data breach, with the exception of banks, which are obligated to inform the Reserve Bank of India within six hours. The result is that individuals are often not aware that their details may have been compromised. The draft law proposes to make breach notification mandatory. Data breaches would be ranked by severity, and the more serious kind would be punishable with a fine of at least Rs1 lakh and a jail term of up to five years. Clinical establishments and health information exchanges would have to notify the owner in case of a breach within three days. Data owners could claim compensation from the person who breached the data, and no limit has been prescribed for the compensation amount. The draft also specifies punishment for various other offences such as unauthorized access and data theft of up to five years’ imprisonment. ]]> https://biospectrumindia.com/news/22/11046/aimed-applauds-delhi-govts-draft-policy-to-regulate-private-hospitals.html https://biospectrumindia.com/news/22/11046/aimed-applauds-delhi-govts-draft-policy-to-regulate-private-hospitals.html Thu, 31 May 2018 16:15:00 +0530 Mr. Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD) said "We applaud the steps taken by Delhi Govt to lower the costs of treatment and bring more transparency and accountability to private healthcare services in Delhi and NCR. “If hospitals don't follow this advisory to discipline them it will lead to full blown regulations. The ethical hospitals will embrace the prescribed system, the unethical will continue till they are caught red handed and will state they are legally ok. How long can they escape legal regulatory scrutiny?” Added Mr. Nath. The move to clamp down on the private hospitals comes after the state government had appointed a nine-member committee five months ago to suggest the scope of profit margins on medicines and consumables. The committee comprised of members of Delhi Medical Council, Indian Medical Association and some administrators in the health department. It was then reported that Delhi government will issue a policy based on the recommendation of the committee in next few days. The Delhi Govt. on Monday, 28th May 2018 issued the draft advisory that the price of medicines and consumables could be upto a maximum of 50 per cent more than the purchase price, or it could be the MRP, whichever is lower. According to Rajiv Nath; Delhi Government shows the way to other State Government and sets precedence, Central Govt should take the cue and expedite Revision of DPCO and Trade Margins Rationalisation. "This will result in consumers’ access to medical devices at prices below inflated MRP. If this happens game over to artificially keep MRP at exorbitant levels by any of the US manufacturers and importers as an inducement to push medical devices sales to hospitals." said Mr. Nath.  Of course lobbying forces for high priced medical devices suppliers will be worried as they will loose the competitive advantage of inducing procurement bodies based on higher margins as the cap becomes a leveller. This will bring back the focus to cost reduction and operational efficiencies by hospitals to remain competitive and profitable.   Let's hope other State Health Ministers follow this lead by Delhi Govt and NPPA and DoP consider this as a possible reform in the regulations for Price Controls of Medical Devices.   ]]> https://biospectrumindia.com/news/22/11041/pfizers-xalkori-receives-fda-breakthrough-therapy-designation-.html https://biospectrumindia.com/news/22/11041/pfizers-xalkori-receives-fda-breakthrough-therapy-designation-.html Thu, 31 May 2018 12:30:00 +0530 Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for XALKORI (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy. The FDA also granted Breakthrough Therapy designation for XALKORI for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. MET is a trans membrane tyrosine receptor kinase which is expressed in several types of cells. In patients with NSCLC, MET exon 14 alterations occur in approximately three percent of NSCLC tumors. Anaplastic large cell lymphoma is a rare type of non-Hodgkin lymphoma, divided into ALK-positive or ALK-negative disease. Despite the activity of chemotherapy, many patients with ALCL relapse or require alternative treatment approaches. “Biomarker-driven therapies have changed the way we treat cancer, helping to ensure that patients receive the right medicine for their disease,” said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. “These Breakthrough Therapy designations for XALKORI exemplify our commitment to precision medicine development and delivering medicines that have the potential to transform the lives of patients whose cancers carry these genomic alterations.” XALKORI is currently approved in the U.S. for the treatment of patients with metastatic NSCLC whose tumors are ALK-positive or ROS1-positive as detected by an FDA-approved test. XALKORI became a first-line standard of care for ALK-positive metastatic NSCLC in its first approved indication and has proven to be a practice-changing treatment for patients with ALK-positive and ROS1-positive NSCLC, globally. It is the only FDA-approved treatment indicated for both ALK-positive and ROS1-positive metastatic NSCLC. If approved in patients with metastatic NSCLC with MET exon 14 alterations, XALKORI will be the only TKI with demonstrated efficacy in three separate biomarker-driven indications in NSCLC. The Breakthrough Therapy designation for patients with metastatic NSCLC with MET exon 14 alterations was supported by results from an expansion cohort of the Phase 1 PROFILE 1001 study, in which XALKORI showed antitumor activity.  The designation for patients with relapsed or refractory systemic ALCL that is ALK-positive was supported by the results from Study ADVL0912 (NCT00939770) and Study A8081013 (NCT01121588). Study ADVL0912 is a Phase 1/2 study conducted by the Children’s Oncology Group evaluating the maximum dose that is safe and tolerable, and assessing preliminary clinical activity in pediatric patients with relapsed or refractory solid tumors and ALCL. Study A8081013 evaluated XALKORI in pediatric and adult patients with advanced malignancies known to be ALK-positive other than NSCLC and included patients with relapsed/refractory ALCL. These two studies showed compelling antitumor activity in pediatric and adult patients who received XALKORI. The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a medicine if it is intended to treat a serious or life-threatening disease and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. The Breakthrough Therapy designation is distinct from the FDA’s other mechanisms to expedite drug development and review.   ]]> https://biospectrumindia.com/news/22/11011/central-expert-team-nipah-virus-a-local-occurrence-only.html https://biospectrumindia.com/news/22/11011/central-expert-team-nipah-virus-a-local-occurrence-only.html Fri, 25 May 2018 10:20:00 +0530 Following directions of the Union Health Minister, J P Nadda, a multi-disciplinary Central Team led by the National Centre for Disease Control (NCDC) is presently in Kerala constantly reviewing the situation of the Nipah Virus Disease. After reviewing the cases of all the patients who have lost their lives, the Central High-level Team is of the view that the Nipah virus disease is not a major outbreak and is only a local occurrence. The Team has also further fine-tuned the draft guidelines, case definitions, advisory for healthcare workers, information to the general public, advisories for sample collection and transportation accordingly.   The Central Team held meetings with the District Collectors and the medical and para-medical staff of the hospitals today also to review the condition of the admitted patients and to consider further course of action to be taken to prevent the disease from spreading.  The efforts taken so far for containment of the disease have been fruitful as the disease has not spread to new areas.  The contact tracing strategy adopted has also been successful.  It has been found that all the reported cases including the suspected cases had direct or indirect contact with the first casualty/his family prior to contacting the disease. General awareness among the general public has been encouraging.  They have been asked to follow safe hygiene practices, not to consume fruits/vegetables partly eaten by birds/animals and steps to be taken while going near the infected persons/areas. The State Government has also issued advisories in the vernacular.  The continued round-the-clock presence of the Central and State Teams in the affected areas right from day one of the outbreak and the surveillance and preventive actions taken by them, have instilled confidence among the public. The Team also reviewed/discussed with the hospitals the management and treatment of the patients.  The treatment procedure adopted by the hospitals for the patients with specific/non-specific symptoms has been found effective.  The suspect cases admitted in the Kozhikode Medical College and Trivandrum Medical College are under observation. All healthcare workers have adopted safe practices for dealing with the patients.  The Union Minister for Health and Family Welfare is closely monitoring the situation. Details of cases and deaths, as on 24.5.2018, are as under: Total number of confirmed cases: 14 Total number of suspected cases: 20 Total number of deaths:  12 (9 from Kozhikode and 3 from Malappuram) ]]> https://biospectrumindia.com/news/22/11003/expert-central-technical-team-on-constant-nipah-management.html https://biospectrumindia.com/news/22/11003/expert-central-technical-team-on-constant-nipah-management.html Thu, 24 May 2018 10:55:00 +0530 Following directions of the Union Health Minister, J P Nadda, a multi-disciplinary Central team from National Centre for Disease Control (NCDC) is presently in Kerala constantly reviewing the situation of the Nipah Virus Disease. Yesterday, the Expert Central Technical team held meetings with the State Health Minister and Doctors of Government as well as Private Hospitals.  Clinical picture, management and treatment given to the patients were discussed in detail along with contact tracing strategy.  A part of the team led by Dr. S.K. Singh, Director, NCDC visited Malappuram district where they addressed the doctors from Government and Private Hospitals on the Nipah virus disease. The team along with the State Health Minister also interacted with the general public to create awareness and allay any fears in their mind about the disease.  The deceased patients from Malappuram had visited the Government Medical College, Kozhikode at the time of admission of the Index cases and had interaction with the index case.  The team also devised draft guidelines, case definitions, advisory for healthcare workers, information to the general public, advisories for sample collection and transportation and a brief on Nipah virus disease.  A draft reporting format was prepared and shared with experts for cases, suspects and contacts. Another part of the Central Expert Team led by Dr. P.Ravindran, Director(Emergency Medical Relief) visited the Government Medical College, Kozhikode and reviewed the treatment procedure, infection control practises, use and availability of personal protective equipment  (PPE) and availability of drugs, particularly in the designated wards.  An action plan was also developed for the healthcare staff and simulation exercise was planned. Today, the team held meetings with the District Collector, Kozhikode and discussed streamlining the reporting mechanism and strengthening inter-sectoral coordination. It was decided to provide separate ambulances for transportation of the suspects to designated isolation facilities.  The interim guidelines, case definitions, advisories to healthcare workers and information to the general public were shared. Advisories were issued for sample collection and transportation also. The team also visited the Govt. Medical College, Kozhikode and reviewed the treatment procedure, infection control practises and availability of personal protective equipment (PPE) and drugs in the designated wards.  Simulation exercise for healthcare staff was undertaken as per the Action Plan developed. The details of cases and deaths as on date are as under: Total number of confirmed cases: 13 Total number of suspected cases: 16 (15 are admitted in Govt. Medical College, Kozhikode and 1 is admitted in Manjeri Medical College in Malappuram District.   Lab results of these admissions are awaited) Total number of deaths: 11 (8 from Kozhikode District and 3 from Malappuram District) ]]> https://biospectrumindia.com/news/22/10997/sun-pharma-announces-usfda-approval-for-yonsa-.html https://biospectrumindia.com/news/22/10997/sun-pharma-announces-usfda-approval-for-yonsa-.html Wed, 23 May 2018 13:55:00 +0530 Sun Pharmaceutical Industries has announced that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the U.S. Food and Drug Administration for YONSA, a novel formulation in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer. Churchill is eligible to receive upfront and sales-linked milestone payments, and royalties on sales from Sun Pharma pursuant to an agreement between the two companies to commercialize YONSA in the U.S. Churchill Pharmaceuticals is focused on providing value to cancer care by developing quality orally delivered oncology products with optimized clinical profiles. Churchill has a license from iCeutica to the SoluMatrix Fine Particle Technology, a proprietary manufacturing process that may unlock the potential of certain oral drugs by changing how well they dissolve and how efficiently they are absorbed. “We are pleased to add YONSA to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies,” said Abhay Gandhi, CEO - North America, Sun Pharma.  YONSA in combination with methylprednisolone was filed as a New Drug Application (NDA) under the 505(b)(2) regulatory pathway and will be promoted as a branded product in the U.S.   ]]> https://biospectrumindia.com/news/22/10992/health-ministry-reviews-nipah-virus-cases-in-kerala.html https://biospectrumindia.com/news/22/10992/health-ministry-reviews-nipah-virus-cases-in-kerala.html Wed, 23 May 2018 10:55:00 +0530 The Union Minister for Health & Family Welfare, J P Nadda is closely monitoring the situation arising out of reported cases and deaths due to Nipah Virus in Kerala. He has reviewed it with Secretary (HFW) Preeti Sudan and DG (ICMR) Dr. Balram Bhargava and has directed for all support to be extended to Kerala in its prevention and management. Following directions of the Union Health Minister, a multi-disciplinary Central team from National Centre for Disease Control (NCDC) is presently in Kerala constantly reviewing the situation. The Central team includes Dr.Sujeet K Sing, Director, NCDC; Dr. S K Jain, Head Epidemiology, NCDC; Dr. P Ravindran, Director, Emergency Medical Relief (EMR);Dr Naveen Gupta, Head Zoonosis, NCDC; Dr Ashutosh Biswas, Prof Internal Medicine, AIIMS; Dr. Deepak Bhattacharya, Pulmonologist, Safdarjung Hospital along with two clinicians and one expert from Ministry of Animal Husbandry. The NCDC team visited the house in Perambra from where the initial death was reported.  The team found many bats housed in the well from where the family was drawing water.  Some bats have been caught and have been sent for lab examination to confirm whether they are the cause of the disease or not. 60 different samples have been collected from the spot and sent for examination. There are two confirmed cases with history of contact with the index case. They were admitted in the Calicut Medical College Hospital and died due to Nipah virus. The Ministry has mobilized a public health team from NCDC Branch Kozhikode to assess the extent of problem, for risk assessment and risk management.  They are assisting the State Level Team already deployed at the epicentre.  So far, seven patients have been admitted in Baby Memorial Hospital and in the Govt. Medical College at Kozhikode and at the Amrutha Medical College, Ernakulum. Nadda has urged citizens not to believe in rumours posted on social media and not to spread panic.  The field team has advised hospitals to follow intracranial pressure (ICP) guidelines, use personal protective equipment (PPE) for healthcare workers and sample collection; assist in enhancing active fever surveillance in the community; strengthen contact tracing in close contacts of cases, relatives, health care workers; ensure isolation facilities, ventilator support and hospital infection control practices; and coordinate with animal sector and enhance surveillance for unusual illness and deaths in animals. The Ministry has ensured availability of diagnostic kits, personal protective equipment and risk communication materials. High quality personal protection equipment has been provided to health care personnel. A total of nine individuals are currently under treatment. Isolation wards have been opened in many hospitals in Kozhikode. Hospitals in public and private sector have been provided with personal protective equipment. Appropriate steps to contain this virus have been taken among domestic animals such as pigs. Since all the contacts are under observation and steps to avoid exposure through animal vectors have been taken there is no reason for people to panic. This appears to be a localisedoccurrence. With early and efficient containment measures undertaken jointly by the Ministry of Health & Family Welfare and Government of Kerala, the outbreak is unlikely to spread. The Virus Research Diagnostic Laboratory at Manipal Hospital and the National Institute of Virology, apremier institute for research in virology, are geared up to meet any diagnostic challenges that may arise. ]]> https://biospectrumindia.com/news/22/10990/buy-indian-policy-for-medical-devices-lacks-boldness-lost-opportunity.html https://biospectrumindia.com/news/22/10990/buy-indian-policy-for-medical-devices-lacks-boldness-lost-opportunity.html Tue, 22 May 2018 15:50:00 +0530 Mr Rajiv Nath, Forum Coordinator, (AIMED)  Association of Indian Medical Device Industry has expressed deep concern over the Guidelines for implementing the provisions of Public Procurement (Preference to Make in India) Order (PPO) issued by DoP.  “Government of India has the intent but lacks boldness - halfhearted attempts will get halfhearted results. It is a clear case of a lost opportunity to promote indigenous manufacturing of medical devices to boost ‘Make in India’ initiative,” said Mr. Rajiv Nath .  If lowest price of tender bid is imported - Indian Manufacturers (who meets criteria of Domestic Content) has option to match lowest price and seek 50% of tender. If lowest is Indian, no added advantage of course.  DiPP/ DoP need to do a study of gains made (if any) by any MSME in winning Tenders in past by matching L1 Pricing of imported Chinese products to win 20% of Tender under the MSME Policy . If an Indian manufacturer finds it unsustainable to match L1 of lower priced Chinese Imports to get 20% of the business as was earlier too possible then what is the use of this Policy to get 50% of the tender?  We can match prices of any country other than China as it has no global market economies but a subsidized state sponsored eco system. How can we compete with low priced imports from china with non- remunerative, non- sustainable pricing unless Indian Govt. has supportive Policies, Mr.  Nath asked insisting India needs to follow the UN system of procurement based on sustainable costs and not based on L1 Lowest pricing that motivates some manufacturers to cut corners in regard to quality and service delivery of product and give poor image to Brand India.  Regretfully to compete with low priced Chinese imports that are flooding the market, there is No Preferential Pricing for Indian Devices - World Bank provides for this. GoI is strangely shy - though GFR (General Financial Rules) of Ministry of Finance permits.  The guidelines issued by DoP in its present form does not provide Preferential Pricing for Indian Devices, no incentives on maintaining and improving Quality, indigenous development and no redressal / no penal action based disallowance to use exclusionary 3rd Country Regulatory Approvals like USFDA approval in Tenders.  It doesn’t provide preference for ICMED certification by Quality Council of India to promote quality and no stated preference for India Design Mark to promote indigenous product development.  The following suggestions made by us to give encouragement & boost  Manufacturers producing in India over imports have not been considered e.g.,  Preferential Pricing for Domestic Manufacturers based on World Bank norms.  Preference for ICMED / ISO Certified Manufacturers to boost quality.  Preference for Design India Certified Manufacturers to boost indigenous development.  Timely payment against Govt. Supplies.  Penal provision against Hospitals that keep exclusionary compliance Clause of USFDA Certification as 3rd Country Regulatory approval.  What's meant by Preferential Pricing? How does World Bank support Indigenous manufacturers in a developing country?  World Bank has a clause to support domestic manufacturers by adding 15% to import CIF price of imported goods for the sake of bid comparison and thereafter the lowest price is winner. So if Indian manufacturer wins he will supply at his bid price, not at a higher price  By denying preferential pricing to genuine Indian manufacturers, the policy guidelines can be said to be bordering on encouraging ‘Pseudo manufacturing’, he felt. It is sad that genuine concerns and suggestions of Domestic Medical Device Manufacturers are being repeatedly sidelined. ]]> https://biospectrumindia.com/news/22/10983/india-is-firmly-committed-to-achieving-uhc-jp-nadda.html https://biospectrumindia.com/news/22/10983/india-is-firmly-committed-to-achieving-uhc-jp-nadda.html Tue, 22 May 2018 10:35:00 +0530 “India is firmly committed to achieving universal health coverage for its citizens as has been articulated in our National Health Policy 2017.” This was stated by J P Nadda, Union Minister for Health and Family Welfare during his addresses at the Plenary Meeting of the 71st World Health Assembly, at Geneva recently. The Health Minister spoke on the theme: Health for All: Commit To Universal Health Coverage. Reiterating the commitment of the government, the Union Health Minister said that India has fast-tracked many initiatives aimed at achieving all the tenets of Universal Health Coverage i.e strengthening health systems, improving access to free medicines and diagnostics, reducing catastrophic health care spending to translate our vision of achieving UHC. The Union Health Minister further said that our Prime Minister, Narendra Modi, has recently launched Ayushman Bharat. The programme rests on the twin pillars of Health and Wellness Centres, the provision of comprehensive primary healthcare services and the Prime Minister’s National Health Protection Mission for secondary and tertiary care for 100 million families covering 500 million individuals. “We are reaching out to approximately 40% of the country’s population who will be provided an insurance cover of Rs 500,000 per year. This will be the world’s largest government funded health protection scheme in the world” Nadda added. Nadda further said that to reduce the burden of NCDs, India has already initiated universal screening for prevention and management of five common NCDs: hypertension, diabetes and three common cancers – those of the oral cavity, breast and cervix for individuals at pan India level. We have also started providing medicines for cancers, cardiovascular diseases and cardiac implants at significantly reduced prices,” Shri Nadda elaborated.  Nadda informed the participants that in line with India’s ambitious plan to end TB by 2025, the Government has started the implementation of the National Strategic Plan for TB and allocated 550 million dollars. “Apart from rapid scale up of diagnostics and treatment, we have introduced supplementary nutrition for patients for duration of treatment,” Nadda said. Earlier, J P Nadda also addressed the Commonwealth Health Ministers Meeting on the sidelines of the 71st World Health Assembly and spoke about the global fight against Non-Communicable Disease (NCDs). He said that interventions for prevention and control of NCDs are to be prioritized and are to be integrated at all levels of health care delivery systems.  He said that for comprehensive management of lifestyle related disorders, a pilot project on ‘Integration of AYUSH with National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS)’ has been initiated. Synergy is being harnessed between Allopathy system under NPCDCS and alternative systems of medicine under AYUSH, for prevention and management of ‘lifestyle-related’ common NCDs, he added. In another address at the Commonwealth Health Ministers’ Meeting, Nadda spoke on the Universal Health Coverage Funding Mechanisms in the Commonwealth. Nadda said that both developed as well as developing countries are aspiring to achieve Universal Health Coverage through either a purely tax-funded regime, or risk pooling under social health insurance mechanisms or a mix of both. India has followed a mix of these strategies and so far, revenues from general taxation are the primary source of government funding, since coverage under the social health insurance is low due to low proportion of organised workforce. “India’ s National Health policy, 2017 commits to achieving a target of raising public health expenditure to 2.5% of the GDP in a time bound manner by 2025 and the government is committed to providing the resources for achieving Universal Health Coverage,” J P Nadda also inaugurated ‘Walk the Talk’ event and gave a call ‘Health for all, Yoga for all’. He also led the yoga session ahead of 71st World Health Assembly. Delegates from across the world participated in the yoga session. Nadda said that Yoga can help in several medical conditions and want to spread it globally and be embraced by people so that they can benefit from it. The Union Health Minister also held bilateral meetings with his counterparts from UK, Brazil and Sweden on the side-lines of World Health Assembly.   ]]> https://biospectrumindia.com/news/22/10978/dcgi-to-come-out-with-vaccine-specific-regulatory-policy.html https://biospectrumindia.com/news/22/10978/dcgi-to-come-out-with-vaccine-specific-regulatory-policy.html Mon, 21 May 2018 12:55:00 +0530 The Drugs Controller General of India, S. Eswara Reddy has announced that he plans to come out with vaccine specific regulatory policy and a manual for regulatory requirements for commercialization of new drug and how to conduct clinical trials in India. Speaking at a symposium on ‘research and development of vaccines: issues, challenges and opportunities organized by PC2 Scientific Services, a strategic and technical consulting company in association with Federation of Asian Biotech Associations (FABA) and CR RAO AIMSCS at University of Hyderabad, he said that since pneumococcal is one of the majority vaccines, they would first come out with a policy to facilitate introducing indigenously-produced vaccines. He further listed out the steps being taken by his organization to promote innovation through transparent system and regulatory changes. He also proposed to conduct symposiums across India and invite research institutions to know their regulatory challenges. The regulator will reach out to research and innovation centres by disseminating information about the regulatory requirements for commercialization of their products. Reddy underlined the need to communicate to media the facts about the deaths due to clinical trials. He told the gathering that media gives a wrong projection about the number of deaths. He said that although media reports that during last 7-8 years, 25,000 patients died during clinical trials in India, the fact is that only 5 percent of these deaths are actually due to clinical trials. "For example, during clinical trials related to cancer, patients who are already in terminal stage die. The death of such patients is not due to clinical trials," he said. With the drug developers and researchers raising concern about the restrictions on import of animal models, the Drug Controller General hoped that the Union Environment and Forests Ministry would look into the issue. He said the import of animals was restricted by the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) guidelines and suggested that the innovators, industry and regulator make a joint representation on the issue. Some participants spoke how the researchers were forced to go abroad because of non-availability of such animals in the country for studies and the restrictions on the import. Reddy said the issues was relating in the country losing its credibility and the forex reserves. Manuel Elkin Patarroyo, the malaria vaccine scientist from Columbia, was the keynote speaker. The symposium was attended by delegates from scientific research & academic and industry both from India and abroad. Dr. Dasari V Ravi Kumar, Director of PC2 Scientific Services, pointed out that Hyderabad is producing about 33 per cent of global vaccines dosages and 35 per cent to the pharmaceutical production in the country. ]]> https://biospectrumindia.com/news/22/10981/ayush-finds-a-place-in-english-language-for-scientific-purposes.html https://biospectrumindia.com/news/22/10981/ayush-finds-a-place-in-english-language-for-scientific-purposes.html Mon, 21 May 2018 12:55:00 +0530 The Commission for Scientific and Technical Terminology has decided to adopt the word ‘AYUSH’ in Hindi and English languages for scientific and technical purposes. The “AYUSH” became popular as the acronym for five traditional and complementary systems of medicine, namely Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy and successfully adopted and used in all Government communications. The decision follows a proposal from the Ministry of AYUSH in this regards. Hailing this decision, Shripad Naik, the Union AYUSH Minister said, “It would underline the essential unity of all holistic systems of healing.  He also said that this decision would add strength to the efforts of the Ministry of AYUSH to develop integrated solutions to manage the public health challenges of the Country.” As approved by the Commission, the word ‘ayush’ will have the meaning “Traditional and Non-Conventional Systems of Health Care and Healing which include Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa Rigpa, Homoeopathy etc. Following the Commission’s recognition, the word is expected to gain currency in popular usage in a short span of time. Despite many commonalities, the practice of the Ayush systems of healthcare in India have remained fragmented in system-specific silos.  Today’s decision in the long term is expected to highlight the unifying features of the different systems.  It would facilitate projects and activities of larger scope to emerge, and thereby promote faster development of these systems.  This decision will also give a boost to India’s efforts to find a place for the Indian Systems of Healthcare in the International Classification of Diseases (ICD) of the World Health Organization.  The Indian systems finding a place in ICD will lead to their international acceptance, increased rigor of research in them and their over-all development. ]]> https://biospectrumindia.com/news/22/10980/glenmark-pharma-gets-usfda-nod-for-colesevelam-hydrochloride-tablets.html https://biospectrumindia.com/news/22/10980/glenmark-pharma-gets-usfda-nod-for-colesevelam-hydrochloride-tablets.html Mon, 21 May 2018 12:20:00 +0530 Glenmark Pharma said it has received final approval from the US health regulator for Colesevelam Hydrochloride tablets, 625 mg, the generic version of Daiichi Sankyo's Welchol tablets, 625 mg. Colesevelam hydrochloride is a lipid-lowering and glucose-lowering agent used to lower "bad" cholesterol in the blood. Welchol is sometimes used together with other cholesterol-lowering medications. It is also used to improve glycemic control in people with type 2 diabetes. "Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Colesevelam Hydrochloride tablets, 625 mg," the company said in a BSE filing today.  The company said it has already commenced supplies of the product to the US market. Quoting IQVIA sales data for the 12-month period ending March 2018, Glenmark Pharma said the Welchol tablets, 625 mg, achieved annual sales of approximately USD 519.9 million. ]]> https://biospectrumindia.com/news/22/10972/india-sign-mou-with-equatorial-guinea-in-medicine.html https://biospectrumindia.com/news/22/10972/india-sign-mou-with-equatorial-guinea-in-medicine.html Fri, 18 May 2018 12:55:00 +0530 The Union Cabinet chaired by Prime Minister Narendra Modi  gave its ex-post facto approval to the Memorandum of Understanding (MoU) between India and Equatorial Guinea for Cooperation in the field of traditional systems of medicine. The MoU on the same was signed on April 8 during President Ram Nath Kovind's visit to Equatorial Guinea. The MoU will enhance bilateral cooperation between the two countries. The financial resources necessary to conduct research, training courses, conferences and meetings and deputations of experts will be met from the existing allocated budget and existing plan schemes of Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani and Siddha).   The traditional systems of medicine in India are well organised, codified and well-documented. These systems hold tremendous potential in the global health scenario. The two countries also approved a MoU in the field of medicinal plants. The MoU will further enhance bilateral cooperation between the two countries. The financial resources necessary to conduct research, training courses, conferences and meetings will be met from the existing allocated budget and existing plan schemes of the National Medicinal Plants Board of the Ministry of AYUSH. India is one of the richest countries in the world in terms of biodiversity, having 15 agro-climatic zones. Out of the 17,000-18,000 species of flowering plants, more than 7,000 are estimated to have medicinal usage in folk and documented systems of medicine. About 1,178 species of medicinal plants are estimated to be in trade of which 242 species have annual consumption levels in excess of 100 metric tonnes per year. There is a global resurgence in traditional and alternative health care systems resulting in world herbal trade which stands at USD 120 billion and is expected to reach USD 7 trillion by 2050. Moreover, there are a large number of medicinal plants, particularly in the tropical regions, which are common to the two countries, given the similar geo-climatic factors.   ]]> https://biospectrumindia.com/news/22/10971/provide-stents-free-of-cost-to-bpl-group-health-minister.html https://biospectrumindia.com/news/22/10971/provide-stents-free-of-cost-to-bpl-group-health-minister.html Fri, 18 May 2018 11:55:00 +0530 Union Minister of State for Health Ashwini Kumar Choubey recently stated that stents used in the treatment for heart ailments would be provided free of cost to all persons below poverty line (BPL). He also said the prices of the stents have come down significantly now than what they used to be earlier. On another issue, Choubey was asked about Punjab health minister Brahm Mohindra on Monday refusing to sign the memorandum of understanding (MoU) for 'Ayushman Bharat' on the ground that the Punjab government was already running similar schemes. The four states and the Union Territory of Chandigarh had inked the MoUs with the Union Health Ministry at an event in Shimla recently for the implementation of 'Ayushman Bharat-Pradhan Mantri Rashtriya Swasthya Suraksha Mission'. However, Choubey said, "We are not going to leave any state. We are talking to them (Punjab) and I am hopeful that in coming days it will be solved (they will onboard)." He further stated that 'Ayushman Bharat' campaign has to be made a people's movement. The ambitious national health protection mission aims to provide an annual coverage of Rs 5 lakh per family. The Union minister informed that the Centre had recently launched a TB-free India campaign in a bid to eradicate the disease by 2025. "We are now moving towards generic medicines. We have opened 3,217 centres under 'Pradhan Mantri Bhartiya Jan Aushadhi Yojana" Choubey added. He also said that cancer detection centers at district level were being opened where preliminary screening would be done. The minister said that while strength of the AIIMS institutes in the country will be increased to 20 by 2022, on the other hand Ayush centres are being opened in the existing AIIMS. Choubey said the government is committed to bring the healthcare system closer to homes through 1.5 lakh health and wellness centres as part of the 'Ayushman Bharat' programme. In total Rs. 1200 crore has been allocate to 1.5 lakh centres which we have to change into wellness centres, he said. ]]> https://biospectrumindia.com/news/22/10960/cabinet-approves-mou-for-cooperation-in-the-field-of-traditional-systems-of-medicine-.html https://biospectrumindia.com/news/22/10960/cabinet-approves-mou-for-cooperation-in-the-field-of-traditional-systems-of-medicine-.html Wed, 16 May 2018 18:45:00 +0530 The Union Cabinet Chaired by Prime Minister Narendra Modi has given its ex-post facto approval to the Memorandum of Understanding (MoU) between India and Equatorial Guinea for Cooperation in the field of Traditional Systems of Medicine.  The MoU was signed on 8th April, 2018. The MoU will enhance bilateral cooperation between the two countries in the areas of Traditional Systems of Medicine. The financial resources necessary to conduct research, training courses, conferences/ meetings and deputations of experts will be met from the existing allocated budget and existing plan schemes of Ministry of AYUSH. Cabinet has also given its approval to the signing of Memorandum of Understanding (MoU) between India and Colombia on establishing cooperation on Traditional Systems of Medicine of India. It will lead to promotion and propagation of Traditional Systems of Medicines of India in Colombia. As a consequence of this MoU, exchange of experts for training the practitioners, conducting collaborative research in Traditional Systems of Medicine is expected to lead to new innovations in drug development and traditional medical practice. ]]> https://biospectrumindia.com/news/22/10959/cabinet-approves-mou-between-india-and-swaziland-.html https://biospectrumindia.com/news/22/10959/cabinet-approves-mou-between-india-and-swaziland-.html Wed, 16 May 2018 18:25:00 +0530 The Union Cabinet Chaired by Prime Minister Narendra Modi has given its ex-post-facto for the Memorandum of Understanding (MoU) between the India and Swaziland on cooperation in the field of Health and Medicine. The MoU was signed on 9th April 2018. The MoU covers the following areas of cooperation:- i) Drugs & Pharmaceutical products; ii) Medical Consumable products; iii) Medical Research; iv) Medical Equipment; v) Public Health; vi) Communicable Disease Control & Surveillance; vii) Health Tourism; and viii) Any other area of mutual interest. A Working Group will be set up to further elaborate the details of cooperation and to oversee the implementation of this MoU.     ]]> https://biospectrumindia.com/news/22/10958/cabinet-approves-mou-between-india-and-colombia-.html https://biospectrumindia.com/news/22/10958/cabinet-approves-mou-between-india-and-colombia-.html Wed, 16 May 2018 18:15:00 +0530 The Union Cabinet chaired by chaired by Prime Minister Narendra Modi has given its approval to the signing of Memorandum of Understanding (MoU) between India and Colombia on establishing cooperation on Traditional Systems of Medicine of India. It will lead to promotion and propagation of Traditional Systems of Medicines of India in Colombia. As a consequence of this MoU, exchange of experts for training the practitioners, conducting collaborative research in Traditional Systems of Medicine is expected to lead to new innovations in drug development and traditional medical practice. ]]> https://biospectrumindia.com/news/22/10957/cabinet-approves-mou-on-cooperation-in-the-field-of-medicinal-plants-.html https://biospectrumindia.com/news/22/10957/cabinet-approves-mou-on-cooperation-in-the-field-of-medicinal-plants-.html Wed, 16 May 2018 18:10:00 +0530 The Union Cabinet Chaired by Prime Minister Narendra Modi has given its ex-post facto approval to the Memorandum of Understanding (MoU) on Cooperation in the field of Medicinal Plants between India and Equatorial Guinea. The MoU will further enhance bilateral cooperation between the two countries in the area of Medicinal Plants. The financial resources necessary to conduct research, training courses, conferences / meetings will be met from the existing allocated budget and existing plan schemes of the National Medicinal Plants Board, Ministry of AYUSH. Out of the 17000-18000 species of flowering plants, more than 7000 are estimated to have medicinal usage in folk and documented systems of medicine like Ayurveda, Unani, Siddha & Homoeopathy (AYUSH System of Medicine). About 1178 species of medicinal plants are estimated to be in trade of which 242 species have annual consumption levels in excess of 100 metric tons/year. Medicinal plants are not only a major resource base for the traditional medicine & herbal industry but also provide livelihood and health security to a large segment of Indian population. There is global resurgence in traditional and alternative health care systems resulting in world herbal trade which stands at $ 120 billion and is expected to reach $ 7 trillion by 2050. Moreover, there are a large number of medicinal plants, particularly those found in tropical region, which are common to the two countries given similar geo-climatic factors.       ]]> https://biospectrumindia.com/news/22/10956/cabinet-approves-mou-between-india-and-equatorial-guinea-.html https://biospectrumindia.com/news/22/10956/cabinet-approves-mou-between-india-and-equatorial-guinea-.html Wed, 16 May 2018 18:05:00 +0530 The Union Cabinet Chaired by Prime Minister Narendra Modi has given its ex-post facto approval to the Memorandum of Understanding (MoU) between India and Equatorial Guinea for Cooperation in the field of Traditional Systems of Medicine.  The MoU was signed on 8th April, 2018 and will enhance bilateral cooperation between the two countries in the areas of Traditional Systems of Medicine. The financial resources necessary to conduct research, training courses, conferences/ meetings and deputations of experts will be met from the existing allocated budget and existing plan schemes of Ministry of AYUSH. The Ministry of AYUSH having the mandate to promote, propagate and globalize these Traditional Systems has taken effective steps by entering into MoU with Malaysia, Trinidad & Tobago, Hungry, Bangladesh, Nepal, Mauritius, Mongolia, Iran and Sao Tome & Principe for cooperation in the field of Traditional Medicine.       ]]> https://biospectrumindia.com/news/22/10936/fda-expands-approval-of-gilenya-to-treat-ms-in-pediatric-patients.html https://biospectrumindia.com/news/22/10936/fda-expands-approval-of-gilenya-to-treat-ms-in-pediatric-patients.html Mon, 14 May 2018 13:25:00 +0530 The US Food and Drug Administration (FDA) has approved Gilenya (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis (RMS), making it the first disease-modifying therapy indicated for these patients. This approval expands the age range for Swiss pharma giant Novartis’ blockbuster drug Gilenya, which was previously approved for patients aged 18 years and older with RMS. Gilenya was granted Breakthrough Therapy designation by the FDA in December of 2017 for this pediatric indication. In the first quarter of this year Gilenya generated sales of $821 million, a year-on-year rise of 8%.  “For the first time, we have an FDA-approved treatment specifically for children and adolescents with multiple sclerosis,” said Billy Dunn, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. While MS is mostly diagnosed in adults, children and adolescents with the chronic disease often experience more frequent relapses and brain lesions than adults with MS. "Since revolutionizing the treatment of relapsing MS as the first oral disease-modifying therapy, Gilenya has become an important mainstay of treatment for adult patients," said Paul Hudson, chief executive of Novartis Pharmaceuticals.   ]]> https://biospectrumindia.com/news/22/10931/president-of-india-addresses-international-nurses-day-celebrations.html https://biospectrumindia.com/news/22/10931/president-of-india-addresses-international-nurses-day-celebrations.html Mon, 14 May 2018 11:50:00 +0530 The President of India, Shri Ram Nath Kovind, graced and addressed the International Nurses Day Celebrations organised by the Ministry of Health and Family Welfare in New Delhi on May 12, 2018. Speaking on the occasion, the President said that International Nurses Day is an occasion for the entire nursing community to remember Florence Nightingale and renew their commitment to her ideals. Florence Nightingale had established nursing as a service to humanity. She motivated nurses to follow the path of dedication, commitment and compassion. The President noted that at present, there are 1.7 nurses per 1,000 people in India, but the world average is 2.5 nurses. He stated that in the past few years, the number of institutions for nursing education has increased. As a result, the number of registered nurses and other health workers had crossed 27 lakh till March 2017. But this number is not sufficient because the need for nurses is growing. The President said that the nursing community has a vital role in keeping our country healthy. A nurse who is helping a patient, in a remote village, in fighting a serious illness is a nation-builder. The nursing community serves the people with devotion and commitment and the entire nation is grateful for this. ]]> https://biospectrumindia.com/news/22/10928/chinas-ease-of-import-plans-fail-to-create-buzz.html https://biospectrumindia.com/news/22/10928/chinas-ease-of-import-plans-fail-to-create-buzz.html Mon, 14 May 2018 11:35:00 +0530 China's much-publicized announcement to slash tariffs on 28 medicines, including cancer drugs from India, has failed to create any buzz among the Indian pharmaceutical firms here as exports to China are possible only after lengthy field trials and approvals, which could take years, an official at an Indian firm has said. On May 4, China, the second largest market for pharmaceuticals after the US, said it has removed import duties on as many as 28 medicines, including all cancer drugs, from May 1, a move which would help India to export these pharmaceuticals to the neighbouring country. "China has exempted import tariffs (duties) for 28 drugs, including all cancer drugs, from May 1. Good news for India's pharmaceutical industry and medicine export to China. I believe this will help reduce trade imbalance between China and India in the future," Chinese Ambassador to India Luo Zhaohui said in a tweet. Luo's announcement generated optimism that India's persistent demand from China to provide opening for Indian pharmaceutical firms to market their economically priced drugs compared to the multinational firms may be realised. However, the official with the Indian pharmaceutical company said it is surprising to see the reports from the Indian media that the move to reduce tariffs will pave the way for exports of Indian pharmaceutical firms. "For Indian pharmaceutical companies, it is not going to be much different as imports of Indian drugs both generic and anti-cancer is possible only with the approval of China Food and Drug Administration (CFDA)," the official told PTI on the condition of anonymity. The announcement has not created any enthusiasm among the Indian firms as for both oral and injectable drugs a lengthy process of clearances is required in China which may take anywhere between two and half years to three years. India has been lobbying actively with China to ensure quick clearances but it has not worked so far, he said. Any export to China at this point of time is possible only if Beijing accepts certification by US Food and Drug Administration, which has approved a whole host of Indian drugs. "As regards India benefiting because China has lifted import tariffs, I do not see it as a measure that is specifically favouring the Indian pharmaceutical products alone," V Viswanath, a Beijing based senior consultant for Indian, Chinese as well as multi-national pharmaceutical firms told PTI. "This will benefit all imported products irrespective of which the country of origin is," he said, highlighting the long drawn out struggle by Indian pharmaceutical firms to enter Chinese markets despite persistent campaign. India has been asking China for long to open up its IT and pharmaceutical firms to reduce the trade deficit which has claimed to over $50 billion. But ahead of Luo's announcement, China's Cabinet or State Council on April 12 has approved a proposal that China will exempt import tariffs on all cancer drugs and encourage the import of more innovative drugs. From May 1, import tariffs on all common drugs including cancer drugs, cancer alkaloid-based drugs, and imported traditional Chinese medicine will be exempted, state-run Xinhua news agency quoted an official statement as saying. Value Added Tax in the production and import of drugs will drop by a large margin, it said. The authorities will reduce the prices of cancer drugs through centralised government procurement and eliminate premium prices for drugs by means of cross-border e-commerce, it said. Imported innovative drugs, especially much-needed cancer drugs, will be incorporated into the catalogue of medical insurance reimbursement, the statement said. So as of now there is nothing specific for Indian pharmaceutical industry as such, the Indian pharma firm, the Indian pharma firm official said. The move is aimed at reducing exorbitant costs of medicines in general and cancer drugs in particular by the multinational firms in China, he said. The tariff reduction is also not going to amount much as it accounts to only about three to four percent, which is negligible, he said. In fact, the reimbursement for cancer drugs by the provincial and central governments is aimed at prevailing on the innovator multinational companies to reduce their prices, which they will considering the size of the Chinese market, he said. With reimbursement on cards the multinational companies are going to bring down their prices to cash in on the scheme, he said adding that this may even stop the rampant smuggling of Indian cancer drugs to China as prices will come down. "Pharma companies in general and Indian Pharma companies in particular have struggled to get their products approved by the China Food and Drug Administration (CFDA) which is the first step in commercialisation of products. Pharmaceuticals can only be imported and sold in China if they are registered with CFDA," Viswanath said. The announcement by China to import Indian drugs need to be "followed up with a more specific bilateral arrangement between China and India", he said. This is necessary as quality pharmaceutical products which are at very affordable prices are given fast-track approvals in CFDA. "This could save China significant healthcare costs and also help the suffering Chinese patients to pay out of their own pocket for the treatment," he said. ]]> https://biospectrumindia.com/news/22/10924/mr-vaccination-is-safe-emphasize-medical-specialists-of-pgimer-and-who.html https://biospectrumindia.com/news/22/10924/mr-vaccination-is-safe-emphasize-medical-specialists-of-pgimer-and-who.html Fri, 11 May 2018 18:30:00 +0530 In a recent press conference chaired by Punjab’s health and family welfare minister Brahm Mohindra, medical specialists from World Health Organization (WHO) and Post Graduate Institute of Medical education and Research (PGIMER), Chandigarh have emphasized that MR (measles and rubella) vaccination was totally safe and people should remain away from rumours suggesting otherwise. Specialists included PGIMER’s additional professor of pediatrics department Dr. Sanjay Verma and WHO’s Dr. Srinivasan. Dr. Srinivasan said that the MR vaccine was produced by Pune-based Serum Institute of India under strict quality control and was a WHO pre-qualified vaccine. He also added same vaccine was being exported to European countries and the US. He said measles is number one killer among vaccine preventable disease with more than one lakh deaths globally, including 30% happening in India. Dr Verma said measles and rubella disease was still a big challenge and cause of disability and mortality as he himself attends to several such patients in PGIMER. Addressing media, the health minister condemned the false propaganda against the vaccination campaign on social media.  Mohindra said around eight crore children across 14 states and Union Territories have been vaccinated till date with this vaccine. He added in Punjab around 14 lakh children have been administered the MR vaccine till Thursday. Mohindra appealed to the parents to get their children aged between 9 months and 15 years vaccinated with the MR vaccine and help eliminate these two diseases. ]]> https://biospectrumindia.com/news/22/10920/railway-board-partners-with-hospitals.html https://biospectrumindia.com/news/22/10920/railway-board-partners-with-hospitals.html Fri, 11 May 2018 12:50:00 +0530 The railway board has asked the respective chief medical directors of Railways to explore ways to enter into contracts with the Central Government Health Scheme empaneled private hospitals located within the railways jurisdiction to cover all its beneficiaries serving and retired railway employees and their families.  In a letter, the deputy director of Health and Family Welfare, Railway Board, H K Sanhotra stated that the Central Government’s Health Scheme (CGHS) covers all the beneficiaries, serving and retired employees and their family members who may be required to be referred to these hospitals. Once a hospital has been recognized by any unit of the railways, it shall be empaneled for the whole of Indian Railway. Every unit shall be uploading the list of hospitals empaneled by it on a website, where anybody can go for treatment. The zones were delegated powers to empanel the ESI recognised hospitals located within their jurisdiction, apart from CGHS hospitals. At least one hospital should be empaneled in every district. There may be situations where a government or autonomous institute run hospitals is having its own rates different from those of CGHS. In such situations, if the hospital is not ready to provide service at CGHS rates, then the hospital rates may be followed.   ]]> https://biospectrumindia.com/news/22/10912/high-risk-drugs-packs-must-carry-prominent-warnings.html https://biospectrumindia.com/news/22/10912/high-risk-drugs-packs-must-carry-prominent-warnings.html Thu, 10 May 2018 16:20:00 +0530 In a move to enhance consumer awareness and accountability of pharma companies, the health ministry has made it mandatory for high-risk medicines to carry warnings prominently on drug packs from November 1.  The new rules will be applicable to medicines such as cancer drugs, narcotics analgesics, sedatives, tranquillisers, steroids and anti-depressants which have either a high risk of side effects or are to be used strictly under medical supervision.  The changes are part of the new labelling rules under the Drugs and Cosmetics (Fifth Amendment) Rules, 2018. According to the norms, the label of the innermost container of such drugs - categorised under Schedule G or Schedule H or Schedule H1 or Schedule X in - will bear a caution or warning in legible black-coloured ink in a red rectangular box. These medicines also include some antimicrobials, anti-epileptics and anticoagulants.  The new rules specify that if the medicine contains a drug substance specified in Schedule H, G or X, it will be labelled with symbol Rx, like cancer drugs, anti-depressants and steroids.  In case of substances specified under Schedule H1, which comes within the purview of the narcotic drugs and psychotropic substances Act, 1985, the packaging will be labelled with symbol NRx, in red colour with caution statement on the left top corner. This will cover mainly narcotics analgesics.  The government's move is aimed at bringing in transparency while also preventing sale of prescription drugs over the counter. Officials say the main objective is to help make consumers aware. "Prominent warning will ensure that consumers are aware of the risk and side-effects attached with a medicine," an official said.   The Indian drug retail market is pegged at over Rs 1 lakh crore annually, of which 75-80% is prescription drugs. ]]> https://biospectrumindia.com/news/22/10906/pm-reviews-preparations-for-launch-of-health-assurance-programme-.html https://biospectrumindia.com/news/22/10906/pm-reviews-preparations-for-launch-of-health-assurance-programme-.html Thu, 10 May 2018 11:00:00 +0530 The Prime Minister, Narendra Modi, recently reviewed the progress of preparations towards the launch of the ambitious Health Assurance programme under Ayushman Bharat. He was apprised of the preparation done so far, including consultations with States, for the smooth and expeditious rollout of the Health Assurance programme. The scheme will provide a cover of upto Rs. 5 lakh per family. It will be targeted to cover over 10 crore poor and vulnerable families. The Prime Minister stressed on providing maximum benefit to the poor and marginalized sections of society, under this scheme. Top officials of the Ministry of Health and Family Welfare, NITI Aayog and PMO, briefed the Prime Minister on various aspects of the scheme. Last month, on the occasion of Ambedkar Jayanti, the Prime Minister had inaugurated the first 'Health and Wellness Centre' under Ayushman Bharat, in the aspirational district of Bijapur in Chhattisgarh. ]]> https://biospectrumindia.com/news/22/10899/cdsco-extends-whos-gmp-certificate.html https://biospectrumindia.com/news/22/10899/cdsco-extends-whos-gmp-certificate.html Wed, 09 May 2018 14:50:00 +0530 In a move to improve ease of doing business, India is increasing the validity of the World Health Organization’s (WHO) Good Manufacturing Practices (GMP) certificate to three years. The measure, taken up by the Central Drugs Standard Control Organization, would also result in more product registration for exports. The protocol for clinical trial approvals has also been changed by setting the timeline of approval at 45 days. Once approval does not come within this timeline, the protocol would deemed to be approved.  According to the drug controller general of India, Eshwara Reddy the certificate was earlier valid for only two years. With this extension, the government is hoping to promote pharmaceutical exports to untapped markets, including China, which has agreed for a high level bilateral round table to pave way for Indian pharma to get market access and penetration in their market. They are also placing emphasis on the need for reaching out to newer markets in Africa, where affordability is a key issue that can be addressed by Indian exporters  ]]> https://biospectrumindia.com/news/22/10884/roches-tecentriq-to-receive-fda-priority-review.html https://biospectrumindia.com/news/22/10884/roches-tecentriq-to-receive-fda-priority-review.html Mon, 07 May 2018 13:55:00 +0530 Roche Holding AG has been granted a priority review for its drug Tecentriq, for the first-line treatment of a type of lung cancer, by the U.S. Food and Drug Administration. Tecentriq is currently FDA approved for the treatment of patients with metastatic non-squamous non-small cell lung cancer, or NSCLC. Roche says the FDA review would be for the use of Tecentriq in combination with Avastin and chemotherapy after phase 3 trial results showed potential to provide significant survival benefit in the initial treatment of NSCLC. ]]> https://biospectrumindia.com/news/22/10883/union-asks-states-to-prioritise-locations-for-hwcs.html https://biospectrumindia.com/news/22/10883/union-asks-states-to-prioritise-locations-for-hwcs.html Mon, 07 May 2018 13:50:00 +0530 A National Consultative meeting hosted by the Union health ministry has asked all states to prioritise locations to establish the proposed Health and Wellness centres (HWCs). The HWCs are aimed at providing comprehensive primary care services to local populations. This update has come after the Centre’s announcement, earlier this year, to turn 150,000 sub-centres across the country into HWCs, that would screen people for diabetes, cardiovascular diseases and breast, oral and cervical cancers and provide reproductive and child health services. The establishment of healthcare services and staff at the sub-centres is expected to take place in a phased manner to achieve 150,000 operational HWCs by 2022. For the first year, the states have been asked to identify primary health centres and HWCs in blocks and districts where infrastructure and human resources are in place, and to conduct orientation programmes for district teams on developing comprehensive primary healthcare services. ]]> https://biospectrumindia.com/news/22/10881/health-ministry-to-mandate-red-band-warning-on-all-listed-drugs-.html https://biospectrumindia.com/news/22/10881/health-ministry-to-mandate-red-band-warning-on-all-listed-drugs-.html Mon, 07 May 2018 12:05:00 +0530 The ministry is planning to stop the drug abuse menace by make changes to the text printed on medicine strips, especially those that fall under Schedule G, Schedule H, Schedule X and Schedule H1. According to a recent notification issued by the health ministry, the medicine strips will contain a red block with black letters stating the caution or warning. The new changes on these drugs will come into effect from November 1 this year. These new guidelines have to be followed by every drug manufacturing company. The central government had earlier invited objections and suggestions on the proposal on November 3, 2017.  In 2016, India’s drug industry has opposed the Union health ministry’s proposal of making a red band mandatory with black letters on packaging labels of prescription-only drugs, claiming that this would increase manufacturing costs and had pitched for an alternative labelling plan. But now, the government has made it mandatory to have this printed on medical strips.  Pallavi Darade, state commissioner of Food and Drug Administration (FDA), said, “It is a good move and through its implementation even the common man will come to know that these drugs are different from other common drugs and one has to be more careful while consuming them. Now not only pharmacists, doctors and chemists, even the general public will easily come to know about the consequences of using these drugs and will make them more cautious about it. The new law will allow FDA to track the sale of scheduled drugs throughout the state making it mandatory for drugs stores to maintain records. This is to keep self-medication by such drugs in control.” Sleeping pills and narcotic drugs will now have a warning or caution printed on them. This will help to create awareness in the minds of people who are buying these drugs. ]]> https://biospectrumindia.com/news/22/10875/china-eliminates-import-duties-on-28-indian-medicines.html https://biospectrumindia.com/news/22/10875/china-eliminates-import-duties-on-28-indian-medicines.html Fri, 04 May 2018 11:50:00 +0530 China has removed import duties on as many as 28 medicines, including all cancer drugs, from May 1, a move which would help India to export these pharmaceuticals to the neighbouring country.  The development assumes significance as India has time and again asked for greater market access for its goods and services, including IT, pharmaceuticals and agriculture, in the Chinese market to reduce the widening trade deficit.  In the meeting of India China Joint Group on Economic Relations, Trade, Science and Technology, the issue of trade imbalance was discussed in detail. China on its part promised to address the trade gap issue.  Trade deficit with China stood at USD 36.73 billion during April-October 2017-18. It was USD 51 billion in 2016-17.  Chinese Ambassador,Luo Zhaohui said, “China would further improve business environment by halving time required to open a business. China’s door to the outside world will open wider”. India too has sought investments from China. The neighbouring country has agreed to set up Industry Park in India to increase investments and bridge trade deficit. ]]> https://biospectrumindia.com/news/22/10873/orchard-therapeutics-otl-200-receives-rpd-designation-from-fda.html https://biospectrumindia.com/news/22/10873/orchard-therapeutics-otl-200-receives-rpd-designation-from-fda.html Fri, 04 May 2018 11:05:00 +0530 Orchard Therapeutics, a leading commercial stage company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies, announced that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation to the company’s gene therapy candidate OTL-200, for the treatment of patients with metachromatic leukodystrophy (MLD). MLD is a rare, fatal, neurodegenerative, inherited metabolic disease caused by mutations in the ARSA gene. In its late infantile and juvenile forms, which represent the majority of MLD patients, mortality at 5 years is estimated at 75% and 30%, respectively.  The FDA grants Rare Pediatric Disease Designations for serious or life-threatening diseases with manifestations in individuals aged from birth to 18 years, including access to the FDA’s expedited review and approval process. The Rare Pediatric Disease Designation makes the program eligible for a Rare Pediatric Disease Priority Review Voucher upon approval of OTL-200 by the FDA. OTL-200 was acquired by Orchard from GSK in April 2018 and originated from a pioneering collaboration between GSK and the Hospital San Raffaele and the Telethon Foundation, acting through their joint Telethon Institute for Gene Therapy, in Milan, initiated in 2010. This collaboration led to the development of Strimvelis, the world’s first approved autologous ex vivo gene therapy product. Orchard anticipates filing OTL-200 for market authorization with regulatory authorities from 2019.   ]]> https://biospectrumindia.com/news/22/10869/cabinet-approves-setting-up-of-20-aiims-across-india.html https://biospectrumindia.com/news/22/10869/cabinet-approves-setting-up-of-20-aiims-across-india.html Thu, 03 May 2018 14:35:00 +0530 The Union Cabinet chaired by Prime Minister Narendra Modi recently approved a plan to set up 20 All India Institute of Medical Sciences (AIIMS) across the country, six of which have already been established, and to upgrade 73 medical colleges. The decisions are part of the Pradhan Mantri Swasthya Suraksha Yojana (PMSSY), which has been extended by two years till 2020, with a financial outlay of Rs 14,832 crore. The construction of new AIIMS will be fully funded by the Central government. It will also bear the operations and maintenance expenses of these facilities. The upgradation programme broadly envisages improving health infrastructure through construction of super specialty blocks, trauma centres and others. The procurement of medical equipment for existing as well as new facilities will be done on sharing basis by both Central and state governments. ]]> https://biospectrumindia.com/news/22/10865/j-p-nadda-reviews-preparedness-of-states-to-manage-vector-borne-diseases.html https://biospectrumindia.com/news/22/10865/j-p-nadda-reviews-preparedness-of-states-to-manage-vector-borne-diseases.html Wed, 02 May 2018 17:10:00 +0530 Emphasising the need for early preparedness to be adequately in a position to manage vector borne diseases such as Dengue, Malaria, JE,  Kala Azar , Chickungunya, Lymphatic Filariasis in the coming monsoon months, J P Nadda, Union Minister of Health and Family Welfare reviewed the status of vector-borne diseases and the preparation of States through video conference. He interacted with Principal Health Secretaries and Mission Directors of 20 endemic States –Andhra Pradesh, Assam, Arunachal Pradesh, Bihar, Chhattisgarh, Delhi, Gujarat, Haryana, Jharkhand, Karnataka, Kerala, Madhya Pradesh, Maharashtra, Odisha, Punjab, Rajasthan, Tamil Nadu, Tripura, UP and West Bengal. Manoj Jhalani, AS&MD, Promila Gupta, DGHS, VikasSheel (JS) and other senior officers of the Union Health Ministry, National Vector-Borne Disease Control Programme (NVBDCP), National Centre for Disease Control (NCDC) were also present in the meeting. The advance review at the level of the Health Secretaries and senior officials of the States was done in view of the predicted upsurge of vector borne diseases at the onset of monsoon. He reviewed that, “The availability of diagnostic kits, drugs, testing labs, manpower and funds. Awareness being the key to prevention of many diseases.” Nadda stressed on the importance of conducting focussed and intensive IEC campaigns and sustaining them through the monsoon season. He advised that best practices from states like Gujarat and Tamil Nadu may also be emulated. Minister further stated that the focus should be on active case finding for source identification and reduction of vectors. He said adequate attention should be given to building sturdy surveillance systems. Effective surveillance and monitoring was key to success in combatting these diseases, he emphasised. The Minister also underscored need to develop special strategy and effective micro-plans for endemic districts. He requested the Health Secretaries to personally guide the State’s efforts and monitor the measures and assured the states of all necessary support to enhance their capacity to manage Vector Borne diseases. The Health Minister also urged States to fill up the vacant posts and wherever necessary redeploy the human resource to endemic areas. Stressing on the importance of inter-sectoral coordination and convergence of efforts in not only the prevention but also management of vector borne diseases such as dengue, malaria etc., Nadda advised them to review and strengthen inter-sectorial coordination. He said that coordination with Rural Development Ministry must also be taken up for construction of pucca houses under PMAY in Kala Azar endemic areas to effect reduction in breeding of sandflies. The Health Minister further reassured the states for all possible help from the Central government.   ]]> https://biospectrumindia.com/news/22/10864/mohfw-restricts-regulation-for-oxytocin-in-india.html https://biospectrumindia.com/news/22/10864/mohfw-restricts-regulation-for-oxytocin-in-india.html Wed, 02 May 2018 15:55:00 +0530 The Ministry of Health and Family Welfare has restricted the manufacture of Oxytocin formulations for domestic use to public sector only. It has also banned the import of Oxytocin and its formulations. The High Court of Himachal Pradesh, Shimla, had, in its judgment dated 15.3.2016 in CWPIL No. 16 of 2014 titled ‘Court on its own motion’ versus State of Himachal Pradesh and others, observed that there is large scale clandestine manufacture and sale of the drug Oxytocin leading to its grave misuse, which is harmful to animals and humans. Amongst others, it had also observed that the feasibility of restricting the manufacture of Oxytocin only in public sector companies should be considered. The matter was considered by the Drugs Technical Advisory Board, a statutory body constituted under the Drugs and Cosmetics Act, 1940. The Board recommended that Oxytocin formulations for human use be regulated and restricted to be supplied only to registered hospitals and clinics in public and private sector to prevent its misuse. The Central Government, on the basis of the recommendations of the Board and after examination of the matter, was satisfied that unregulated and illegal use of Oxytocin is likely to involve risk to human beings or animals and that in the public interest it is necessary and expedient to regulate and restrict its manufacture, sale and distribution to prevent its misuse by unauthorised persons or otherwise. Accordingly, the Central Government has regulated the manufacture for sale or for distribution of Oxytocin under section 26A of the said Act in the following manner:- The manufacture of Oxytocin formulations for domestic use shall be by public sector undertakings or companies only and the label of the product shall bear barcodes. The manufacture of Oxytocin formulations for export purposes shall, however, be open to both public and private sector. The packs of such manufacture for exports shall also bear barcodes. The manufacturers of active pharmaceutical ingredient (API) of Oxytocin shall supply the API only to the public sector manufacturers for manufacture of formulations for domestic use. However, for manufacture of formulations for export purpose, the API will be supplied to the manufacturers in both public and private sector. The Oxytocin formulations meant for domestic consumption will be supplied by the manufacturers to the registered hospitals and clinics in public and private sector directly. The manufacturers can also supply the formulations to the Pradhan Mantri Bhartiya Janaushadhi Pariyojana(PMBJP) and Affordable Medicines and Reliable Implants for Treatment (AMRIT) outlets or any other Government entity which may be specified by the Central Government for this purpose. However, these outlets will further supply the drug to the registered hospitals and clinics in public and private sector. Oxytocin in any form or name will not be allowed to be sold through retail Chemist. The regulations with regard manufacture of Oxytocin for domestic use will come into force on 1st July 2018. However, the ban on import takes immediate effect.     ]]> https://biospectrumindia.com/news/22/10861/strides-shasun-receives-usfda-approval-for-cinacalcet-hydrochloride-tablets.html https://biospectrumindia.com/news/22/10861/strides-shasun-receives-usfda-approval-for-cinacalcet-hydrochloride-tablets.html Wed, 02 May 2018 12:25:00 +0530 Drug firm Strides Shasun’s wholly-owned subsidiary Strides Pharma Global has received approval from the US health regulator for Cinacalcet Hydrochloride tablets, used for treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis.  Strides Pharma has received final approval for Cinacalcet Hydrochloride tablets, 30 mg (base), 60 mg (base), and 90 mg (base) from the United States Food & Drug Administration (USFDA)".  Cinacalcet Hydrochloride tablets is a generic version of Sensipar tablets of Amgen Inc.  Citing IQVIA data, the company said the US market for the approved product is approximately USD 1.8 billion.  The product will be manufactured at the company's oral dosage facility at Puducherry and will be marketed by Strides Pharma Inc. in the US Market. ]]> https://biospectrumindia.com/news/22/10857/csir-bags-national-ip-award-2018.html https://biospectrumindia.com/news/22/10857/csir-bags-national-ip-award-2018.html Wed, 02 May 2018 11:05:00 +0530 The Council of Scientific and Industrial Research (CSIR) has been awarded the National Intellectual Property (IP) Award 2018 in the category “Top R&D Institution / Organization for Patents and Commercialization”. Dr. Girish Sahni, DG, CSIR and Secretary, DSIR received the award at the hands of Mr. Suresh Prabhu, Hon’ble Minister, Commerce and Industry, Government of India, at a function organized by the Indian Intellectual Property Office and Confederation of Indian Chambers of Commerce (CII) in New Delhi, to celebrate the World IP Day.  CSIR is a contemporary R&D organization. It has been ranked 9th in the world amongst the 1207 government institutions, with an overall global ranking of 75 in the world, covering 5250 institutions. Pioneer of India’s intellectual property movement, CSIR today is strengthening its patent portfolio to carve out global niches in select technology domains. CSIR Laboratories have been developing and providing Technology focused at the unmet need and the cutting edge knowledgebase and human resource on the other, for socio-economic development in the Country. The CSIR S&T domains range from environment to health and drinking water, from food, housing, energy to specialty chemicals & petrochemicals, glass & ceramics to mining, metals & minerals, medicinal plants, leather to machinery, instrumentation and strategic sectors including aerospace. It is contributing for the Missions such as Swachh Bharat, Swasth Bharat, Samarth Bharat, Make in India, Innovate for India, Startup India and Skill India. The Indian Intellectual Property Office confers National Intellectual Property (IP) Award on outstanding innovators, organizations and companies in the fields of patents, designs, trademarks and geographical indications on the occasion of World IP Day every year. ]]> https://biospectrumindia.com/news/22/10849/govt-brings-tramadol-under-narcotics-law-regulation.html https://biospectrumindia.com/news/22/10849/govt-brings-tramadol-under-narcotics-law-regulation.html Mon, 30 Apr 2018 11:35:00 +0530 Tramadol, a painkiller pharma drug, has been declared a "psychotropic substance" by the Union government and its sale in the country will now be strictly monitored after the NCB said it was being internationally smuggled, and had possible supply links to the global terror group ISIS.  The Union Finance Ministry, as per data accessed by, has brought the drug under the control of the Narcotic Drugs and Psychotropic Substances (NDPS) Act and a gazette notification to this effect was issued on April 26.  The Finance Ministry regulates certain sections of the NDPS Act like categorisation of pharma drugs as narcotic substances.  The Narcotics Control Bureau (NCB), a national agency to coordinate drug law enforcement action by involving various state agencies, police and central departments, had asked the government in July last year to bring this drug under its "regulation and control" so that it could only be used for medicinal purposes and its abuse be checked. Tramadol, after the notification issued by the Department of Revenue under the Union Finance Ministry, will no longer be available freely over the counter in India. The latest notification will ensure that the availability of Tramadol is substantially reduced and regulated, and agencies like the NCB and police are able to keep a tab on its movement.  "Tramadol is used like codeine (another pharma drug). It is not covered under the NDPS Act, 1985. It is a schedule 'H' drug under the Drugs and Cosmetics Act, 1940 and can only be dispensed under the prescription of a registered medical practitioner.  "lt is also not included in any of the schedules of the 1971 UN convention on psychotropic substances. Internationally, it is banned in many countries and hence is often smuggled through India," the NCB had said in its latest report released in March.  The drug, the NCB had said, "is trafficked via courier and manual means to countries like the US and Canada among others."  Official records state that huge quantities of Tramadol were seized in the country last year, including in July when over 30,000 tablets of Tramadol Hydrochloride were seized from the cargo terminal of the Indira Gandhi lnternational Airport (IGI) along with other pharma drugs. In another instance, in October last year, the NCB seized 710 tablets of Tramadol from the house of a Lucknow-based medicine supplier. These were supposed to be illegally dispatched to the United States of America (USA).  Large volumes of this drug have been seized by the NCB and other anti-narcotics agencies in Punjab in the last few years, and it is suspected that these consignments were finding their way to the ISIS terror group-held locations after being diverted from the original overseas destination, the official said.  The Italian police last year had seized a huge consignment of this drug at the port of Gioia Tauro and it was suspected to be on its way to ISIS terrorists after reportedly being smuggled from the Indian shores, official said.  The manufacture, transport and sale of Tramadol were required to be regulated to not only affirm India's international commitment to fight drug crimes but also to wean away the youth who were abusing it within the country ]]> https://biospectrumindia.com/news/22/10840/cabinet-approves-mou-with-brics-nations.html https://biospectrumindia.com/news/22/10840/cabinet-approves-mou-with-brics-nations.html Thu, 26 Apr 2018 15:00:00 +0530 The government gave its nod to sign a deal with medicine regulatory agencies of BRICS nations on cooperation in the field of regulation of medical products for human use. The approval was given by the Union Cabinet chaired by Prime Minister Narendra Modi. The MoU would facilitate better understanding about the regulatory aspects between the parties and could help in increasing India's export of medical products to BRICS countries. The cabinet also gave its ex-post facto approval for an Memorandum of Understanding (MoU), signed in March, between India and Sao Tome and Principe for cooperation in the field of Traditional Systems of Medicine and Homoeopathy. The MoU between India and Sao Tome will enhance bilateral cooperation between the two countries in the area of Traditional Systems of Medicine. The cabinet also gave ex-post facto approval to an MoU between India and Sao Tome and Principe on cooperation in the field of Medicinal Plants. In another approval, the government has been apprised of the MoU between India and the World Health Organisation, represented by its Regional Office for South-East Asia acting through its India office. The MoU was signed on March 13. The bilateral MoU shall encourage cooperation between India and WHO. This will facilitate in improving public health status of the people in India. ]]> https://biospectrumindia.com/news/22/10837/cabinet-approves-bilateral-cooperation-for-medicinal-plants.html https://biospectrumindia.com/news/22/10837/cabinet-approves-bilateral-cooperation-for-medicinal-plants.html Thu, 26 Apr 2018 12:20:00 +0530 The Union Cabinet Chaired by Prime Minister Narendra Modi has given its ex-post facto approval for the Memorandum of Understanding (MoU) between India and Sao Tome and Principe, Africa on cooperation in the field of Medicinal Plants.  There are a large number of medicinal plants, particularly those found in tropical region, which are common to the two countries given similar geo-climatic factors. “Keeping in view the need for promotion and propagation of AYUSH systems, of medicine and Medicinal Plants Sector in Sao Tome and Principe, our standard draft MoU for country to country cooperation in field of Medicinal Plants was shared with the concerned authorities of the Democratic Republic of Sao Tome and Principe”, said the Cabinet Secretariat, Government of India. India is one of the richest countries in the world in terms of biodiversity, having 15 agro-climatic zones. Out of the 17,000-18,000 species of flowering plants, more than 7,000 are estimated to have medicinal usage in folk and documented systems of medicine like Ayurveda, Unani, Siddha & Homoeopathy (AYUSH System of Medicine). About 1,178 species of medicinal plants are estimated to be in trade of which 242 species have annual consumption levels in excess of 100 metric tonnes per year. ]]> https://biospectrumindia.com/news/22/10822/dr-reddys-receives-eir-from-usfda-for-uk-plant.html https://biospectrumindia.com/news/22/10822/dr-reddys-receives-eir-from-usfda-for-uk-plant.html Tue, 24 Apr 2018 14:35:00 +0530 Dr Reddy's Laboratories received an establishment inspection report (EIR) from the US health regulator after audit of its UK facility. "With regard to the audit of our API Mirfield plant, United Kingdom, we would now like to inform you that we have received an establishment inspection report (EIR) from the USFDA, for the above-referred facility, indicating closure of the audit," Dr Reddy's said in a regulatory filing. The USFDA issues an EIR to the establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection. In September last year, the US health regulator had made three observations after inspecting Dr Reddy's Laboratories' API Mirfield plant, United Kingdom. ]]> https://biospectrumindia.com/news/22/10807/uk-india-extend-health-partnership-for-global-risks.html https://biospectrumindia.com/news/22/10807/uk-india-extend-health-partnership-for-global-risks.html Thu, 19 Apr 2018 12:50:00 +0530 The United Kingdom and India will share research, knowledge and technology in areas of anti-microbial resistance, low cost health products and high yield crops. Prime Minister Theresa May, and Prime Minister Narendra Modi, at the meeting in UK on 18 April agreed to step up the health partnership between the UK and India. The UK-India Statement of Intent on Partnership for Cooperation in Third Countries will be extended, with the aim of improving the health and wealth of both countries. Health research will be expanded in the areas of: anti-microbial resistance low cost health products high yield crops The UK government will invest £1 million in an Artificial Intelligence (AI) project that will support India’s national health programmes. UK-based companies with innovative healthcare technologies will be able to participate in this project, which will generate around £50 million of business for the UK’s digital health industry. There are also plans to develop up to 5,000 diagnostic centres in India using NHS expertise, equipment and suppliers. Eleven new ‘medicities’ are already being developed in India, with related: hospitals nursing and medical colleges research and innovation centres The medicities programme is run by the Indo UK Institute of Health (IUIH) in partnership with leading UK hospitals, the first of which is King’s College Hospital. Secretary of State for Health and Social Care Jeremy Hunt said: “I am proud that our NHS will be used as an example of gold standard healthcare in India – it is only right that our world-leading knowledge and expertise is shared across the globe. Global disease, infection and antimicrobial resistance are real threats to us at home and abroad – this partnership will enable us to tackle 21st century threats together." Health Minister Steve Brine said: “Health expertise and research is a global issue – if we act alone in tackling virulent diseases and long term health threats, we will fail.” This partnership between Britain and India represents a firm trajectory for healthcare into the modern world. Through new research, shared expertise and attention to ground-breaking technologies, both nations can continue to lead the world in health and care. ]]> https://biospectrumindia.com/news/22/10800/govt-should-allow-similar-freedom-to-experts-in-healthcare-and-defence-mtai.html https://biospectrumindia.com/news/22/10800/govt-should-allow-similar-freedom-to-experts-in-healthcare-and-defence-mtai.html Wed, 18 Apr 2018 14:20:00 +0530 Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies with significant manufacturing investments in India, recently stated that the government should follow the experts-will-decide-what-to-buy note set by the Defence Ministry in the Healthcare space as well.On 11th April 2018, Union Defence Minister Smt. Nirmala Sitharaman was quoted as saying her ministry cannot compel Indian armed forces to buy indigenous weapon. “I would want to draw a thin line between the government's enthusiasm to make sure the production capabilities are such that they meet international standards and are export-worthy and the other side of the line where the Army, Navy or Air Force make their decision on what they want, what combination of equipment they want and in that combination if an India produced item fits in well,” she had said.In its statement issued this week, MTaI said, “Defence and medical technology sectors are alike in various aspects, most important being both these sectors deal with protecting the nation’s population. Therefore, the two should be looked at through the same lens as far as the regulatory and procurement roadmap is concerned.India figures low in the list of leading exporters of defence equipment as well as medical equipment. As per recent data compiled by Department of Industrial Policy and Promotion, Ministry of Commerce and Industry, India’s share of export of medical devices is less than 1% across categories. Similarly, India does not figure in top 25 exporters of defence equipment.We want Make in India for medical devices. We just don’t want anything that may prove detrimental to Indian patients considering India’s disease burden is one of the heaviest in the world and is supported up to 80% through imports and one can’t rush a transformation. The other point is the Ayushman Bharat initiative. Which is a laudable programme. And should not falter due to any interruptions in the continued supply of quality critical care medical devices.Procurement of defence equipment for the armed forces and medical devices for public sector hospitals is handled by the government. If the government is keen to offer latitude of choice to armed forces on the quality or nationality of the weapons they choose, it should offer the same level of latitude to its doctors who are not tasked with any less responsibility with regards to ensuring prevention of loss of life. The government should identify those segments of medical devices where adequate manufacturing and quality ecosystem is present within the country before implementing public procurement guidelines. At present, India has adequate manufacturing capabilities for products like syringes, cannulae, stop cocks, extension lines, blood bags, dressings, hospital furniture, and suction machines, but lacks the desired ecosystem for devices requiring complex research, design and engineering support.” ]]> https://biospectrumindia.com/news/22/10779/govt-to-propose-stem-cells-as-drug-legitimize-use-in-therapy.html https://biospectrumindia.com/news/22/10779/govt-to-propose-stem-cells-as-drug-legitimize-use-in-therapy.html Mon, 16 Apr 2018 12:45:00 +0530 The Union health ministry has proposed an amendment to the Drugs and Cosmetics Act that may finally bring stem cells and cell-based products under the ambit of the law. In a notification issued on April 4, the ministry defined the category of stem cells and their derivatives that would be termed a drug, and would thereby have to follow the protocols mandated for any drug development. It said stem cells and products which are substantially altered, amounting to a change in biological characteristics or those subjected to gene editing or modification will be treated as a drug and will have to seek the regulator’s approval before coming to the market. Currently, no such permission required. Stem cells harvested from the umbilical cord and bone marrow has been scientifically proven to treat cancers, immunological diseases, etc. But, over the years, many doctors have started offering stem cell treatment for diseases where efficacy and safety are yet to be established. “It’s a draft and definitely requires more clarity. We are discussing the contents and will submit our suggestions to the health ministry,” said Dr Geeta Jotwani from the ICMR, who was at the helm of framing the 2017 stem cell guidelines. “In a country where stem cell therapy is already exploited, there has to be absolute clarity in defining it. Stem cells are currently being used for genetic disorders, dementia, autism, etc, without explaining to patients or relatives that autologous mononuclear cells transplant is not going to benefit them in any way,” she said. “The health ministry has to define immune therapy, gene therapy and stem cells individually in the Drugs and Cosmetics Act; else the risk of exploiting the science will remain.  Stem cell practitioners though have termed it as the first big step by the government to legitimise the use of such therapies in the country.  “It will change the market because of the clarity that comes with the law. Now there will be an enforcing agency that will regulate and leave the unethical players out of the market,” said Dr Rohit Kulkarni, vice-president, Stem Cell Society of India.   ]]> https://biospectrumindia.com/news/22/10777/pm-inaugurates-health-and-wellness-centre-in-chhattisgarh-.html https://biospectrumindia.com/news/22/10777/pm-inaugurates-health-and-wellness-centre-in-chhattisgarh-.html Mon, 16 Apr 2018 11:10:00 +0530 On the occasion of Ambedkar Jayanti recently, Prime Minister inaugurated a Health and Wellness Centre, to mark the launch of the Union Government’s ambitious Health Assurance Programme – Ayushman Bharat. The Centre was inaugurated at Jangla Development Hub, in the aspirational district of Bijapur in Chhattisgarh. In the course of over one hour, the Prime Minister interacted with a number of people, and was briefed on several development initiatives at the development hub. At the inauguration of the Health and Wellness Centre, he interacted with ASHA workers. He visited a model Anganwadi Centre, and interacted with Anganwadi workers and beneficiary children of Poshan Abhiyan. He visited a Haat Bazaar Health Kiosk and interacted with health workers. He inaugurated a bank branch at Jangla and distributed loan sanction letters under the Mudra Scheme to select beneficiaries. He also interacted with Rural BPO employees. The Prime Minister then arrived at the venue of the public meeting. He launched the Van Dhan Yojana, which aims at empowering tribal communities. It envisages a mechanism for marketing of Minor Forest Produce through Minimum Support Price and development of value chain for MFP. Via video conference, the Prime Minister dedicated to the nation, the Bhanupratappur-Gudum Railway Line. He flagged off a train between Dalli Rajhara and Bhanupratappur. He also inaugurated a dialysis centre at Bijapur Hospital. The Prime Minister laid the foundation stone for construction of 1988 km of PMGSY roads in LWE areas; other road connectivity projects in LWE areas; water supply scheme of Bijapur; and two bridges. Addressing an enthusiastic gathering, the Prime Minister paid homage to the martyrs from the region who had fought against British Imperialism. He also paid homage to the security personnel who laid down their lives in Naxal-Maoist attacks, in the region. The Prime Minister noted that the Union Government had earlier launched two significant development initiatives, the Syama Prasad Mukherjee Rurban Mission, and the Pradhan Mantri Gramin Awaas Yojana, from Chhattisgarh. “Ayushman Bharat and Gram Swaraj Abhiyan, are being launched from the State. The Gram Swaraj Abhiyan would ensure that all development initiatives launched by the Union Government in the last four years, reach the poor and disadvantaged sections of society. The Gram Swaraj Abhiyan would extend from today till the 5th of May.” The Prime Minister said Babasaheb Ambedkar had a key role to play in the establishment of "aspiration" in the hearts and minds of crores of people. Explaining the significance of holding this event in Bijapur, the Prime Minister said that Bijapur is one of the over 100 aspirational districts in the country, which have got left behind in the development journey. He said he wants to convert these districts, hitherto labelled as "backward" into aspirational and ambitious districts. These districts will no longer remain dependent and backward, he asserted. He said that if the district administration, the public representatives and the people all join hands in a mass movement, then, unprecedented results can be achieved. He said the Government is working with a different approach on these 115 districts. “The Ayushman Bharat scheme will go a long way in ending social imbalance, and ensuring social justice in the country. In the first phase of this scheme, an effort would be made to bring about a sea change in primary healthcare. He said sub centres and primary health centres at 1.5 lakh places in the country would now be developed as Health and Wellness Centres. He said the aim is to complete this task by 2022. Health and Wellness Centres would function like a family doctor for the poor”, PM added.  He said the next target of Ayushman Bharat would be to provide financial assistance of upto Rs. 5 lakh to the poor, for medical treatment.   The Prime Minister appreciated the Chief Minister of Chhattisgarh, Dr. Raman Singh, for the development work done in the State over the last fourteen years. In particular, he appreciated the development initiatives carried out in the southern districts of Sukma, Dantewada and Bijapur. He said Bastar would soon be recognised as an economic hub. He emphasized the importance of connectivity for ending regional imbalances. The Prime Minister asserted that the initiatives and decisions taken by the Union Government indicate its commitment to the welfare of the poor and weaker sections of society. In this context, he mentioned the Van Dhan Yojana, and other decisions taken for the benefit of the tribal communities. He mentioned schemes such as Swachh Bharat Mission, Beti Bachao – Beti Padhao, and Ujjwala Yojana, which have benefited women. The Prime Minister asserted that people's participation is the strength of the Government, which will help in the creation of New India by 2022.  ]]> https://biospectrumindia.com/news/22/10770/hc-notifies-cdsco-and-govt-for-steroid-in-skin-creams.html https://biospectrumindia.com/news/22/10770/hc-notifies-cdsco-and-govt-for-steroid-in-skin-creams.html Fri, 13 Apr 2018 14:35:00 +0530 The Centre on Thursday told Delhi high court that it will amend rules to ensure that no topical medications, which contain a "cocktail of harmful steroids", are sold without valid prescription and only by a medical practitioner.  It assured a bench of acting Chief Justice Gita Mittal and Justice C Hari Shankar that in two weeks' time, the government would amend the "footnote to Schedule H" that at present exempts products, such as skin creams, from being treated as a scheduled drug.  The government's stand came in response to a PIL, filed by the Indian Association of Dermatologists, Venereologists and Leprologists (IADVL), seeking a ban on manufacture and sale of several skin creams containing steroids being marketed for skin conditions like pigmentation, itching, fairness and inflammation. In the last hearing, HC had expressed concern over the issue and sent notices to the government and the Central Drug Standards and Control Organisation (CDSCO). It asked the authorities to place their stand before the court.  The petitioner association also sought a high-level inquiry into how CDSCO granted approval for commercial manufacture, use and sale of hazardous, as well as irrational and unscientific, steroid combinations and also ordering prosecution of the officers concerned. ]]> https://biospectrumindia.com/news/22/10765/strides-shasuns-allergy-relief-drug-gets-usfda-approval.html https://biospectrumindia.com/news/22/10765/strides-shasuns-allergy-relief-drug-gets-usfda-approval.html Thu, 12 Apr 2018 17:35:00 +0530 Strides Shasun said its wholly-owned subsidiary has received approval from the US health regulator for Cyproheptadine Hydrochloride tablets, used to relieve allergy symptoms.  Strides Pharma Global Pte. Got nod from the United States Food and Drug Administration (USFDA) for Cyproheptadine Hydrochloride tablets USP, 4mg.  The approved product is a generic version of Periactin tablets of Merck & Co. Inc.  Strides said the product will be manufactured at its oral dosage facility at Bengaluru and will be marketed by Strides Pharma Inc in the US.  Citing IQVIA data, the company said the US market for Cyproheptadine Hydrochloride tablets USP, 4 mg is approximately USD 20 million.  Cyproheptadine Hydrochloride tablets is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, sneezing, hives, and itching.   ]]> https://biospectrumindia.com/news/22/10764/pm-modi-to-launch-indias-first-wellness-centre.html https://biospectrumindia.com/news/22/10764/pm-modi-to-launch-indias-first-wellness-centre.html Thu, 12 Apr 2018 14:55:00 +0530 Prime Minister Narendra Modi will launch the aspirational district programme as well as India's first wellness centre under Ayushman Bharat on April 14 at Bijapur, Chattisgarh.  The two programmes are key initiatives of the NITI Aayog. Under the 'Transformation of Aspirational Districts’ programme, the government aims to quickly and effectively transform the 115 districts based on real-time monitoring.  The broad contours of the programme are convergence (of Central & State Schemes), collaboration of Central, State level ‘Prabhari’ Officers & District Collectors), and Competition among districts driven by a mass Movement. The idea is to focus on the strength of each district, identify low-hanging fruits for immediate improvement, measure progress and rank districts. Under an Ayushman Bharat, government aims to set up 1.5 lakh wellness centre by 2022 that will leverage on comprehensive primary health care for preventive, promotive and curative care.   ]]> https://biospectrumindia.com/news/22/10749/nhm-uses-95-of-the-health-fund-.html https://biospectrumindia.com/news/22/10749/nhm-uses-95-of-the-health-fund-.html Tue, 10 Apr 2018 13:05:00 +0530 In Guwahati, Health minister Himanta Biswa Sarma on Sunday said 95% of the funds allotted for the National Health Mission (NHM) have been utilized by the state to develop the health sector. Sarma said this while giving out the Kayakalp Award to the best performing government health centres in the state at a function. This award is given for maintenance of high standards of hygiene, sanitation and infection control in public hospitals. The Haflong District hospital bagged the best performing hospital award. "NHM has utilized 95% of the funds allotted and this is evident of from the development that is taking place in the health sector of the state. We have introduced so many new schemes to make healthcare accessible to the public residing even in remote areas of the state. We have been able to bring down the maternal mortality rates and infant mortality rates," said Himanta. ]]> https://biospectrumindia.com/news/22/10744/health-ministry-bans-rapid-malaria-diagnostic-tests.html https://biospectrumindia.com/news/22/10744/health-ministry-bans-rapid-malaria-diagnostic-tests.html Tue, 10 Apr 2018 10:15:00 +0530 The Union Health Ministry has banned the use of ‘antibody detecting rapid diagnostic tests’ for routine malaria diagnosis due to concerns over the practicality of the approach. The antibody detection for malaria is carried out through an indirect fluorescent antibody test in patients infected with Plasmodium, which is the known causative organism of the disease. The prohibition is based on the observation that serological testing is not practical for routine diagnosis of the acute form of the disease because of the time required to develop the antibody. The testing is attributed to the persistence of antibodies even after clearance of an active infection and evidence suggests that serology only measures past exposure but does not identify existing infection. While the antibody detecting rapid diagnostic tests are preferred for their low cost and free availability, they are reported to have led to a high false positive rate in endemic areas. The ban will not impact the diagnosis of malaria sufferers as the most common tests used in diagnosis are antigen detecting rapid diagnostic tests and blood smear examination. ]]> https://biospectrumindia.com/news/22/10741/usfda-approves-acyclovir-ointment-by-alembic-pharma.html https://biospectrumindia.com/news/22/10741/usfda-approves-acyclovir-ointment-by-alembic-pharma.html Mon, 09 Apr 2018 12:40:00 +0530 Alembic Pharma has received approval from the US health regulator its Acyclovir ointment USP, used for the treatment of genital herpes. The company has received approval from the USFDA for its abbreviated new drug application (ANDA) Acyclovir ointment USP, 5 per cent, Alembic Pharmaceuticals said in a BSE filing. The approved ointment is therapeutically equivalent to the reference listed drug product (RLD) Zovirax ointment 5 per cent of Valeant Pharmaceuticals North America LLC.  The drug is used for management of initial genital herpes and in limited non-life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients, the company said. As per the IMS data, for twelve months ending December 2016, the ointment has an estimated market size of USD 145 million.   ]]> https://biospectrumindia.com/news/22/10739/health-ministry-bans-otc-sale-of-14-steroid-creams.html https://biospectrumindia.com/news/22/10739/health-ministry-bans-otc-sale-of-14-steroid-creams.html Mon, 09 Apr 2018 11:30:00 +0530 To prevent the indiscriminate sale of ointments containing steroids and antibiotics without prescription, the Union Health Ministry has banned over-the-counter sale of 14 such products.  In a notification issued on March 23, the ministry has put 14 steroid-based creams and ointments under the Schedule H category by making amendments to certain Drugs and Cosmetics Rules, 1945.  The decision was taken following consultation with the Drugs Technical Advisory Board (DTAB) which had recommended a ban on the sale of such creams without prescription and had also submitted their recommendations to the Central Drugs Standards Control Organisation (CDSCO).  The move comes after dermatologists complained that pharmaceutical companies were selling steroid- based creams and ointments to patients who use them without medical guidance.  The revised rules will apply to skin creams that contain steroids or other prescription drugs and not for ordinary face-cleansing and moisturisers.  The creams which have been banned are alclometasone, beclomethasone, desonide, desoximetasone and flucinonide among others. ]]> https://biospectrumindia.com/news/22/10732/rajasthan-government-to-ban-e-cigarette.html https://biospectrumindia.com/news/22/10732/rajasthan-government-to-ban-e-cigarette.html Fri, 06 Apr 2018 13:30:00 +0530 Rajasthan health minister Kali Charan Saraf has taken step forward to restrict the use of e-cigarettes and also considering issuing licences to tobacco vendors. Health department will conduct study on e-cigarettes to find out their ill effects. Health minister Kalicharan Saraf said that if it is found harmful in the study, directions will be issued to ban it in the state. Saraf was addressing a state level seminar on ‘Tobacco-Free Rajasthan’ organised by Vaagdhara, an NGO, in a city hotel on Thursday. He said that the state government is committed to making Rajasthan tobacco free. He said 50,000 people die every year from consuming tobacco and the question that is generally asked is why not ban tobacco in the state and solve the problem. “It is easier said than done,” he added. The government is making people aware about the ill-effects of tobacco so people can quit it, he added. Health minister said more than 1.80 lakh challans have been issued for violation of Cigarettes and other Tobacco Products Act (COTPA) 2003. After making all schools a tobacco-free zone, all the 17,000 government health facilities have been asked to make their premises tobacco-free and letters have been written to private hospitals for the same. Letters have been issued to 6,800 anganwari centres to make their premises tobacco free and to ensure no tobacco products is sold within 100 metres of it.   ]]> https://biospectrumindia.com/news/22/10731/lupin-receives-eir-from-usfda-for-pithampur-facility.html https://biospectrumindia.com/news/22/10731/lupin-receives-eir-from-usfda-for-pithampur-facility.html Fri, 06 Apr 2018 12:45:00 +0530 Drug Pharmaceutical Company has received establishment investigation report (EIR) from the United States Food and Drug Administration (US FDA) for the successful inspection of Pithampur, Unit 1 manufacturing facility in Madhya Pradesh. The inspection was conducted in July 2017. USFDA gives EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted inspection. "The successful outcome of this inspection is encouraging, and further validates our commitment to meeting global manufacturing standards. We are committed to upholding the highest levels of quality and compliance standards across all our facilities,” said Nilesh Gupta, Managing Director, Lupin.   ]]> https://biospectrumindia.com/news/22/10728/hwb-govt-of-india-ink-mou-for-cancer-research.html https://biospectrumindia.com/news/22/10728/hwb-govt-of-india-ink-mou-for-cancer-research.html Thu, 05 Apr 2018 14:35:00 +0530 A first in India, Heavy Water Board (HWB), Department of Atomic Energy (DAE), Government of India has signed a 10-year Memorandum of Understanding with Bengaluru startup SYNMR Chemicals, for uninterrupted supply of Heavy Water for development of deuterium labeled compounds, NMR Solvents, d-labeled Active Pharma Ingredients, used in research and process development solutions in several high-tech research areas like cancer research, medical diagnostics (popular MRI scan), environmental pollution etc. MoU was signed at the 183rd board meeting of HWB and was executed by the chairman and CEO Dr. U. Kamachi Mudali in the presence of board members and joint secretary. SYNMR Chemicals (P) Ltd is a startup company involved in research and process development activities in highly specialized niche area of chemistry called “stable isotope labelling”. SYNMR has already begun supply of labelled compounds to premier institutes like Indian Institute of Science (IISc) and IITs and prestigious companies like Syngene, Apotex etc. and started exporting to countries in South East Asia, China and South Africa.       ]]> https://biospectrumindia.com/news/22/10726/mtai-suggests-gradual-rollout-of-public-procurement-guidelines.html https://biospectrumindia.com/news/22/10726/mtai-suggests-gradual-rollout-of-public-procurement-guidelines.html Thu, 05 Apr 2018 12:35:00 +0530 Medical Technology Association of India (MTaI) today said the Department of Pharmaceuticals (DoP) should prepare a road map for implementation of its guidelines on public procurement in a phased manner to enable optimum patient access to advance medical devices. “Given that India’s medical devices regulatory regime is fairly new and its implementation is nascent, any preferential provisions for public procurement applied to all segments of devices will only limit patient access and forbid several kinds of medical technology that is not locally being produced. In view of the above, we strongly urge the Department of Pharmaceuticals to carve out a road map for a phased implementation of local content requirements in order to boost local manufacturing rather than imposing local content requirements where adequate ground work for promoting localization has not taken place,” MTaI said in the press release. The DoP had issued Draft Guidelines for Implementation of Public Procurement (Preference to Make in India) Order 2017 last month. It had asked for response from stakeholders before finalizing the guidelines. In its response, MTaI has raised concerns on the implementation of preferential market access policy in the medical devices sector. “Make in India for medical devices is a long-drawn approach that will require calibrated steps for enhancement of local capacity of medical devices ranging from less advanced technology to most sophisticated ones. This journey also needs to be meticulously made organic with identification of sub-segments where enough incentives and local resource pool lie and can be garnered with the country-specific capabilities, failing which disruptions in availability and accessibility of life-saving medical devices will only hamper patient access and jeopardize patient safety. MTaI would like to extend all support in working with the government to create a road map for realizing the goal for Make in India in medical devices.”   At present, India has adequate manufacturing capabilities for products like syringes, cannulae, stop cocks, extension lines, blood bags, dressings, hospital furniture, and suction machines, but lacks the desired ecosystem for devices requiring complex research, design and engineering support, it added.   “If the government feels the dire need to implement such preferential policy, it should exempt devices that are used in critical health conditions where quality and safety cannot be compromised,” the association said. “The government should also mandate requirement of 3-year market presence and verification of financial standing of bidders in order to ensure their credibility. In this, global standards of certification / quality management and product standards such as USFDA approval / CE mark / CDSCO standards should be adhered to,” it added. It is important to note that huge costs are incurred by innovation-based companies in ensuring safety and efficacy of medical devices and therefore these costs should be considered for calculating the percentage of local content, MTaI said. “The costs are being incurred on activities like R&D, cold chain management, and maintenance in India, which generate local employment and hence should be included in calculation of local content,” the association added. MTaI said the government should also exempt all procurements by premium research institutes, teaching institutes, tertiary hospitals of Central or State Government such as AIIMS, SGPGI, PGIMER, Sree Chitra, Army Research and Referral, Railways and Defense Departments from the purview of the order. “Since the basic objective of these research Institutes and hospitals is to train the clinicians on use of medical devices, new technologies and do research on new therapies, preferential procurement provisions for such institutions will limit their reach to most latest and cutting edge technology for want of local content,” MTaI said. ]]> https://biospectrumindia.com/news/22/10715/health-minister-urges-private-hcps-to-invest-in-jk.html https://biospectrumindia.com/news/22/10715/health-minister-urges-private-hcps-to-invest-in-jk.html Tue, 03 Apr 2018 16:40:00 +0530 In continuation of its commitment to bringing world-class healthcare to all citizens, Medanta - The Medicity’s Division of Peripheral Vascular and Endovascular Sciences, Gurugram organized a Scientific Interaction Programme for the medical practitioners across Jammu. The interactive session was organized as part of Medanta’s continuous efforts to promote medical knowledge which has a direct impact on patients in Association with VSICON 2018 & Department of CTVS Govt Medical College Jammu, Association of Hospital Administration (AHA) and Academy of Hospital Administrations, Jammu. Minister for Health & Medical Education, Bali Bhagat was chief guest on the occasion. The well-known Vascular Surgeon, Dr. Rajiv Parakh, Chairman, Peripheral Vascular and Endovascular Sciences at Medanta shared new advancements and innovations in vascular surgery for treating diabetic foot and aneurysms. The health Minister said that such programmes are very useful for the local doctors which help them in updating their knowledge in advancements in their fields. He urged the doctors to take advantage of the event and utilize the knowledge for best patient care. He lauded the endeavors of Medanta Group for promoting healthcare and providing specialized OPD services for the patients in Jammu. He urged the group to invest in healthcare sector in Jammu and Kashmir and supplement government efforts in providing quality healthcare to the people of this State. He said Government is keen to promote private sector under PPP mode and all leading health providers of the country are welcome to set up their ventures in Jammu and Kashmir for which the Government will extend them necessary support. ]]> https://biospectrumindia.com/news/22/10710/strides-shasuns-generic-ibuprofen-receives-usfda-approval-.html https://biospectrumindia.com/news/22/10710/strides-shasuns-generic-ibuprofen-receives-usfda-approval-.html Mon, 02 Apr 2018 17:00:00 +0530 Drug firm Strides Shasun has received approval from the US health regulator for generic Ibuprofen capsules, 200 mg, used for relieving pain. The company's wholly-owned subsidiary Strides Pharma Global has received approval for Ibuprofen capsules in the strength of 200 mg from the United States Food & Drug Administration (USFDA). The company's product is a generic version of Pfizer Inc's Advil Liqui-Gels 200 mg. "With a focus to secure its API supply chain for the product, the company under prior approval supplements filing will apply for a source change to Solara Active Pharma Sciences, a group company having a leading API franchise," Strides Shasun said. The product will be commercialised in Q4 of FY19 post completion of API source change process.The product will be manufactured at the company's oral dosage facility in Bangalore. The company has 74 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 45 ANDAs have been approved as of date and 29 are pending approval. ]]> https://biospectrumindia.com/news/22/10708/dr-reddys-promius-pharma-file-nda-for-dfn-02-to-treat-migraine-.html https://biospectrumindia.com/news/22/10708/dr-reddys-promius-pharma-file-nda-for-dfn-02-to-treat-migraine-.html Mon, 02 Apr 2018 15:10:00 +0530 Dr Reddy's Laboratories Ltd and its subsidiary, Promius Pharma, LLC have announced the filing of New Drug Application (NDA) for its migraine candidate DFN-02 with the U.S. Food and Drug Administration (USFDA). According to Dr. Anil Namboodiripad, Senior Vice President, Proprietary Products and President, Promius Pharma, the NDA for DFN-02 is an important step forward in the company’s mission to bring solutions that address unmet needs. "The filing of DFN-02 NDA represents our continuing commitment to bring innovative solutions in migraine treatment," Namboodiripad said. "Acute migraine attacks are typically associated with pain and symptoms, such as nausea, photophobia, and phonophobia. It is important that an effective migraine treatment helps address associated symptoms. Equally important is having a well-tolerated treatment that provides patients a satisfactory resolution of their migraine attack," he added. In a multicentre, double-blind, randomised, placebo controlled study with 107 subjects, DFN-02 has demonstrated that it can effectively treat pain and associated symptoms during a migraine attack, the Hyderabad-based Dr Reddy's claimed in a statement. Upon approval, the product will be commercialised by Promius Pharma. ]]> https://biospectrumindia.com/news/22/10678/5-year-jail-and-rs-5-lakh-fine-for-data-breach.html https://biospectrumindia.com/news/22/10678/5-year-jail-and-rs-5-lakh-fine-for-data-breach.html Wed, 28 Mar 2018 13:25:00 +0530 According to the draft Digital Information Security in Healthcare Act (DISHA), serious breaches of health care data should be punishable by up to five years in jail and a fine of up to Rs5 lakh. The draft enables the owners to have the right to privacy, confidentiality, and security of their digital health data and the right to give or refuse consent for generation and collection of such data. It will be considered a serious digital health data breach if a person commits a breach of digital health data intentionally, dishonestly, fraudulently or negligently, sharing information which is not anonymised or de-identified and where a person failed to secure the data as per the standards prescribed by the Act or any rules. If any person uses the digital health data for commercial purposes or commercial gain, or clinical establishment or health information exchange commits breach of digital health data repeatedly, the person will be liable for punishment. The information including but not limited to, one’s physical or mental health condition, sexual orientation, use of narcotic or psychotropic substances, consumption of alcohol, sexual practices, Human Immunodeficiency Virus status, Sexually Transmitted Infections treatment, and abortion will be considered as sensitive information to be protected.  Making the health data security laws more stringent, any person or entity charged with data breach will not be able to challenge the punishment in court. The Central and state adjudicating authorities formed under the Act will have powers of a civil court, according to the draft. As per the draft, digital health data may be generated, collected, stored, and transmitted by a clinical establishment and by health information exchanges for various purposes including advancing the delivery of patient-centred medical care, to provide appropriate information to help guide medical decisions and to improve coordination of care and information among hospitals, laboratories, medical professionals, and other entities through an effective infrastructure for secure and authorized exchange of digital health data.  The draft legislation prepared by the ministry of health and family welfare has also proposed to constitute a national electronic health authority (NeHA) which would function as an independent regulator. The NeHA will formulate rules, standards and processes for developing and managing electric health records (EHR). ]]> https://biospectrumindia.com/news/22/10679/5-year-jail-and-rs-5-lakh-fine-for-data-breach.html https://biospectrumindia.com/news/22/10679/5-year-jail-and-rs-5-lakh-fine-for-data-breach.html Wed, 28 Mar 2018 13:25:00 +0530 According to the draft Digital Information Security in Healthcare Act (DISHA), serious breaches of health care data should be punishable by up to five years in jail and a fine of up to Rs5 lakh. The draft enables the owners to have the right to privacy, confidentiality, and security of their digital health data and the right to give or refuse consent for generation and collection of such data. It will be considered a serious digital health data breach if a person commits a breach of digital health data intentionally, dishonestly, fraudulently or negligently, sharing information which is not anonymised or de-identified and where a person failed to secure the data as per the standards prescribed by the Act or any rules. If any person uses the digital health data for commercial purposes or commercial gain, or clinical establishment or health information exchange commits breach of digital health data repeatedly, the person will be liable for punishment. The information including but not limited to, one’s physical or mental health condition, sexual orientation, use of narcotic or psychotropic substances, consumption of alcohol, sexual practices, Human Immunodeficiency Virus status, Sexually Transmitted Infections treatment, and abortion will be considered as sensitive information to be protected.  Making the health data security laws more stringent, any person or entity charged with data breach will not be able to challenge the punishment in court. The Central and state adjudicating authorities formed under the Act will have powers of a civil court, according to the draft. As per the draft, digital health data may be generated, collected, stored, and transmitted by a clinical establishment and by health information exchanges for various purposes including advancing the delivery of patient-centred medical care, to provide appropriate information to help guide medical decisions and to improve coordination of care and information among hospitals, laboratories, medical professionals, and other entities through an effective infrastructure for secure and authorized exchange of digital health data.  The draft legislation prepared by the ministry of health and family welfare has also proposed to constitute a national electronic health authority (NeHA) which would function as an independent regulator. The NeHA will formulate rules, standards and processes for developing and managing electric health records (EHR). ]]> https://biospectrumindia.com/news/22/10675/niti-aayog-signs-soi-with-sap-global-.html https://biospectrumindia.com/news/22/10675/niti-aayog-signs-soi-with-sap-global-.html Wed, 28 Mar 2018 11:20:00 +0530 NITI Aayog’s Atal Innovation Mission (AIM) recently announced the signing of a Statement of Intent (SOI) with SAP to promote a culture of innovation and entrepreneurship. As part of the SOI, SAP in 2018 will adopt 100 Atal Tinkering Laboratories (ATL) for five years to nurture the science, technology, engineering and mathematics (STEM) learning among secondary school children across India. Acknowledging the importance of such collaborations, Amitabh Kant, CEO of NITI Aayog, said, “India’s growth for the next few decades will depend on the innovations coming out of these tinkering labs. Tomorrow’s ideas come from students, who will disrupt industries and creative sectors with new technologies and processes which will thrust India into the leadership position for technological creativity and innovation.” “This is possible only through effective public-private partnership and we are delighted to have SAP partner with us on AIM to nurture the future talent of our country”. The program aims to enable students to learn advanced technology topics relevant to digital transformation and the Internet of Things, e.g. Design Thinking methodology, introduction to programming languages and experiential science learning”, he added. The Atal Innovation Mission (AIM) is Government of India’s flagship initiative to promote a culture of innovation and entrepreneurship in the country. AIM is mandated to create an umbrella structure to oversee innovation ecosystem of the country and revolutionizing the innovation eco-system - touching upon the entire innovation life cycle through various programs. Atal Tinkering Laboratories (ATLs) create innovators, Atal Incubation Centre and support to Established Incubation Centre will take the innovations to the market and a network of Incubators shall help create enterprises around these innovations. Ramanathan Ramanan, Mission Director, AIM, added, “Such partnerships are a win-win situation for AIM and its partners. This partnership shall help support and boost innovations from the ATLs. The support to Atal Incubators will catalyze adoption of the innovations to commercial scales, ensuring deployment of the innovations to the domestic and international markets quickly and efficiently.” NITI Aayog’s AIM envisions the creation of a collaborative ecosystem, where students, teachers, mentors and industry partners work to facilitate innovation, foster scientific temper and an entrepreneurial spirit in the children of today, who will go on to become successful contributors to nation-building tomorrow. SAP employee volunteers will coach and mentor students in advanced technology topics and the design lab of SAP Labs India, will provide trainings and allow students to gain hands-on experience with technology gadgets. Till date, AIM has already announced selection of 2441 schools across India to establish ATLs, covering 93% of the total districts in India and 98% of the upcoming smart cities representing all states and 5 out of 7 UTs. In the last one year, more than 50,000+ school students have been engaged in ATLs.   ]]> https://biospectrumindia.com/news/22/10674/avantor-earns-appreciation-from-nsci.html https://biospectrumindia.com/news/22/10674/avantor-earns-appreciation-from-nsci.html Wed, 28 Mar 2018 11:05:00 +0530 The National Safety Council in India (NSC) recently awarded the Avantor® cGMP manufacturing facility in Panoli, Gujarat, India, with a Certificate of Appreciation in the manufacturing sector covering the “Manufacture of Chemicals & Chemical Products, Manufacture of Pharmaceuticals, Medicinal Chemical and Botanical Products.” The NSC in India was established by the Ministry of Labour, Government of India, in 1966 to generate, develop and sustain a voluntary movement on safety, health and environment at the national level. The objective of the NSC awards program is to recognize consistent and meritorious Occupational Safety and Health (OSH) performance; recognize effective implementation of OSH management systems, practices and procedures; and encourage continual commitment to OSH. According to Devashish Ohri, Avantor executive vice president, APAC & MEA, the company’s Panoli facility has achieved a zero Total Recordable Incident Rate (TRIR) for the past five years. “Safety plays an integral role in the operations and management of our facility,” Ohri said. “This certificate is a strong endorsement of our unwavering commitment to provide our employees with the training, tools and technology they need to ensure a safe and healthy work environment.” Avantor’s Panoli plant is ISO 9001:2008 certified and approved by the Indian Food and Drug Administration. The facility produces high-purity solvents, salts and solutions under cGMP conditions that comply with Indian Pharmacopoeia (IPC), U.S. Pharmacopeia (USP), National Formulary (NF), European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and British Pharmacopoeia (BP). The company’s global cGMP manufacturing capabilities are backed by global quality control systems and Management of Change (MOC) notification processes, so it can serve its customers’ needs, regardless of their locations. ]]> https://biospectrumindia.com/news/22/10662/icmr-sends-proposals-for-2-tb-vaccine-trials.html https://biospectrumindia.com/news/22/10662/icmr-sends-proposals-for-2-tb-vaccine-trials.html Tue, 27 Mar 2018 10:45:00 +0530 India’s apex body for biomedical research, Indian Council of Medical Research (ICMR), has recently sent proposals for clinical trials of two new tuberculosis (TB) vaccines to various states as well as civic health officials. The trials are likely to start within the next four to five months. The current TB vaccine, Bacille Calmette-Guérin (BCG), administered to newborns has not proven to be widely effective, especially against the disease’s drug-resistant strains. The two vaccines, named VPM1002 and M Indicus Pranii (MIP), have been through safety trials earlier. While VPM1002 is the joint effort between the German Max Planck Institute and Serum Institute of India, MIP is a collaboration between the Indian department of biotechnology and Cadilla Pharmaceuticals. While initial proposals for the clinical trials have been sent to the Bangalore Medical College, a detailed round of discussions between doctors and scientists from across the country is scheduled for next month. ]]> https://biospectrumindia.com/news/22/10656/we-support-make-in-india-for-quality-medical-devices-reasonable-pricing-mtai.html https://biospectrumindia.com/news/22/10656/we-support-make-in-india-for-quality-medical-devices-reasonable-pricing-mtai.html Mon, 26 Mar 2018 14:25:00 +0530 Medical Technology Association of India (MTaI), which represents research-based medical technology companies with significant investments in Manufacturing in India, today said broad-brush criteria for public procurement will cause proliferation of manufacturing of low quality products in India while high quality components retain their axis abroad. At present, India has got adequate manufacturing capabilities for products like syringes, cannulae, stop cocks, extension lines, blood bags, dressings, hospital furniture, and suction machines, but lacks the desired ecosystem for devices like heart lung machines, pacemakers, complex catheters, etc. Probir Dass, Director, MTaI said, “Unlike several other sectors, medical devices are comprised of thousands of very varied products in engineering and design complexity. A uniform 25-50% local content ask, preceding any meaningful scaling up of the missing sophisticated component ecosystem will create a risk of ‘garage manufacturing’ with low cost – low quality Chinese knocked-down kits based assembly.”  "This is compounded by the fact that India’s medical devices regulatory regime is new, the rules and their implementation is nascent, and the country’s materio-vigilance programme will take time to scale up. Any preferential provisions for public procurement at this stage must only be limited to products where India has existing manufacturing capacity. The capacity should be validated by credible third parties like PWC & KPMG,” he added. Pavan Choudary , MTaI Chairman and Director said, “MTaI members applaud the government’s Ayushman Bharat initiative and are committed to support all initiatives that ensure growth of the sector. But somewhere there is an over-simplification of a complex problem. Measures like price capping and preferential market access without taking into account the complexity of the sector are going to create obstacles in realization of ‘Make in India’ goal. This year the FDI in medical devices was clearly pipped to cross USD 1 billion, thanks to this government’s move of bringing it on the automatic route. However, it has dipped to just USD 184 million. Why did the FDI lose it trajectory of growth is what the government should ask.” “It has clearly been evidenced that the arbitrary price control mechanism has created uncertainty among global MedTech majors about India. This weakening sentiment is certainly counterproductive to Make in India. Also, the growth of the high quality, organised private hospital segment in India was on the back of the availability of globally the best/innovative products. If the same products exit India, there will certainly be a shrinkage of the organised private sector healthcare. This will have a detrimental effect on the market size, and thus on Make in India”, he added. Sanjay Bhutani, MTaI Director said, “Trade margins should be rationalised on the basis of price to trade in case of imported products and price to distributor in case of locally manufactured products. “Different medical devices have different market adoption investment requirements (e.g. a hypodermic syringe may not have the same physician training investment needs as a trans-catheter heart valve). Therefore, different marketers require different levels of profitability that is both fair and logical. Hence, TMR should be based on Price to Trade, which takes into account investments in training, localisation R&D, government taxes and surcharges.” “If TMR is based on landed cost in case of imports none of these intermediate costs would be accounted for and the whole ecosystem would lose money, which is detrimental for the overall health of the sector. Similarly ex-factory cost as a starting point for domestic manufacturers is prone to huge manipulation as observed by the CDSCO. If the government still chooses to base margins on cost, it should consider landed cost for imported products and standard cost for locally manufactured products to create a level-playing field for all players,” Bhutani added. Landed cost for importer and standard cost for local manufacturer are equitable as all sales & marketing expenses, general overheads, inventory cost, training, demo, interest cost, taxes, etc. are incurred post landed cost and standard cost. ]]> https://biospectrumindia.com/news/22/10647/health-ministry-allots-rs-10000-crore-to-implement-modicare.html https://biospectrumindia.com/news/22/10647/health-ministry-allots-rs-10000-crore-to-implement-modicare.html Fri, 23 Mar 2018 15:30:00 +0530 J.P. Nadda, Union minister for health and family welfare announced an allocation of Rs10,000 crore for the government’s ambitious health insurance programme. He said all logistics for the project will be in place by July-end. The announcement came a day after the Union cabinet chaired by Prime Minister Narendra Modi approved the centrally sponsored Ayushman Bharat National Health Protection Mission (NHPM), labelled the world’s largest health insurance scheme. “The beneficiaries have already been identified. The health ministry will start validating beneficiaries in April and ensure that the scheme is ready for implementation in four months’ time,” said Nadda. Health Ministry officials said the government has allocated Rs 10,000 crore for the scheme on initial estimation for the financial years 2018-19 and 2019-20. The funds will be used to cover costs such as setting up an information technology (IT) system, verifying entitled beneficiaries and paying premiums for states opting for an insurance model, said Nadda.  NHPM will be an entitlement-based scheme based on data from the deprivation criteria in the Socio Economic Caste Census. The beneficiaries can avail benefits in both public and empaneled private facilities. In partnership with NITI Aayog, a modular, scalable, and interoperable IT platform will be made operational, which will entail paperless and cashless transactions. “This will also help in prevention, detection of any potential misuse or fraud or abuse cases. This will be backed by a well-defined grievance redressal mechanism,” said Sudan, secretary, Union health ministry. “The scheme will give underprivileged families the financial support required when faced with illnesses requiring hospitalization. It will protect around 50 crore people, or about 10 crore families, from catastrophic healthcare spending,” said Nadda. Approval has been given to the comprehensive healthcare as part of this; the ministry is converting 1.5 lakh health sub-centres into wellness centres, which will have universal screening for breast, cervix and oral cancers along with care for diabetes, hypertension and other ailments, Nadda added. ]]> https://biospectrumindia.com/news/22/10639/cabinet-gives-green-signal-to-ayushman-bharat.html https://biospectrumindia.com/news/22/10639/cabinet-gives-green-signal-to-ayushman-bharat.html Thu, 22 Mar 2018 12:55:00 +0530 The Union Cabinet chaired by the Prime Minister  Narendra Modi has approved the launch of a new Centrally Sponsored Ayushman Bharat -National Health Protection Mission (AB-NHPM) having central sector component under Ayushman Bharat Mission anchored in the MoHFW. It will provide health insurance to about 10.7 crore families which will be from poor and vulnerable populations. The government is hoping that the NHPM will significantly reduce out-of-pocket spending on health by providing the Rs 5 lakh cover to nearly 40 percent of the population paying for almost all diseases requiring secondary and tertiary care.  Under the scheme, famillies may seek hospitalization services from public and private hospitals anywhere in the country empanelled by the government. The benefit cover will include pre and post-hospitalisation expenses. All pre-existing conditions will be covered from day one of the policy. A defined transport allowance per hospitalisation will also be paid to the beneficiary. The eligibility critieria will depend on households’ deprivation levels. In rural areas, for instance, families with only one room with “kucha walls and kucha roofs,” families with no adult members between ages 16 to 59, female-headed households with no adult male member between 16 and 59, household with no able-bodied adult members, Scheduled Caste and Scheduled Tribe households, and landless households that derive most of their income from manual casual labour will be covered. In urban areas, families in 11 occupation categories will be covered in the scheme. Households without shelter, destitutes and those living on alms, manual scavenger families and primitive tribal groups will also be covered in rural areas. ]]> https://biospectrumindia.com/news/22/10638/tripura-govt-to-improve-healthcare-services.html https://biospectrumindia.com/news/22/10638/tripura-govt-to-improve-healthcare-services.html Thu, 22 Mar 2018 12:20:00 +0530 The government of Tripura has announced a three months action plan to improve healthcare facility in the state. Mostly keeping the existing infrastructures intact and strengthening the monitoring mechanism adhering to the regulations. Patients of Tripura go outside for the most common diseases; to stop it the state government is going to start super-specialty service of Cardiology, Neurology and Nephrology by next couple of months in Agartala Government Medical College (AGMC).  To begin with in AGMC the state government would introduce Aadhar based biometric attendance and entire process of service delivery system to bring under CCTV surveillance, which will be closely monitored by a dedicated team of experts.  “After OPD service at 1630 hrs, all the departments of AGMC need to ensure the presence of specialist doctors in the hospital till 2300 hrs and afterwards there will be on call doctor service, whose name and phone number will be displayed category wise for the public. The doctors and staff will be held responsible for any unwanted situation arise out due to service related matter,” Health Minister Sudip Roy Barman stated.  Besides, strengthening and expansion of Telemedicine service up to village level, the government decided to start at least 21 e-hospitals in next three months where people will get assured medical services without any predicament.  Using artificial intelligent, IT based prescription audit will be introduced in all district and state hospitals and doctors must prescribe medicine in generic name, prescribing brand name is strictly prohibited, minister reiterated.  For ensuring healthcare service in a few listed remote locations, the department introduced tenure posting for six months for all categories of medicos and non-medicos. They will be automatically released on the last day of the tenure and new set of people will join, he added.  The proposal for extension of retirement age for state government doctors from 60 to 65 years like the Central government and it will be placed to next cabinet meeting. Moreover, as part of preventive healthcare as many as 29 well-being centres will start functioning apart from a drug de-addiction center at modern psychiatric hospital.  All Auxiliary nurse midwives will be provided with a tab computer to feed data from the ground on real time basis by which preventive healthcare service will be provided, Roy Barman maintained.  The state government will procure at least 50 most modern life support system fitted ambulance and call centre 102 dialing will ensure immediate ambulance service across the state and 104 for grievance redress. ]]> https://biospectrumindia.com/news/22/10632/birac-celebrates-6th-foundation-day.html https://biospectrumindia.com/news/22/10632/birac-celebrates-6th-foundation-day.html Wed, 21 Mar 2018 17:55:00 +0530 The Biotechnology Industry Research Assistance Council (BIRAC) recently celebrated its 6th Foundation Day in New Delhi. Themed as ‘Sustaining Innovation – A Market Driven Pathway’, the event was attended by a large number of dignitaries from the scientific and industry sectors both from within the country and overseas. The Department of Biotechnology, Government of India, and the Bill & Melinda Gates Foundation partnership Grand Challenges India through its Program Management Unit housed at BIRAC (PMU-BIRAC) announced an upcoming new initiative on Antimicrobial Resistance (AMR) directed at encouraging innovations in surveillance data, technologies and products and removing antibiotics from effluents in tackling AMR. The application process will open shortly. BIRAC and PerkinElmer, Inc., USA have agreed to partner with the intention to promote a portfolio of ‘Indian led revenue-based innovations/start ups’ in multidisciplinary areas comprising of medical devices, point of care, algorithms and information technology/ software in thrust areas including maternal health, newborn health and food. Under this partnership calls will be announced to support innovators for funding, mentorship and incubation space. With close association of PerkinElmer, industry partner, from an early stage, the innovators would gain from business mentorship and validation of the product/ technologies to enhance global competitiveness. The event also saw the felicitation of Prof. G Padmanabhan, Former Director and current Honorary Professor of the Indian Institute of Science, Bengaluru, on the occasion of his 80th birthday and the release of the second volume of his memoirs, titled ‘Doing science in India: My second innings’. The event also saw the announcement of the preliminary winners of the SoCH (Solutions for Community Health) awards. This award is an innovation challenge award which was launched on the MyGov portal in September 2017. This challenge has two themes, platform technologies for reducing disease burden (communicable and non-communicable diseases) and sanitation and waste recycling. The winners will now have 6 months and 15 lakhs INR to develop a minimal viable prototype and will then compete for the larger 50 lakh INR award within their categories. ]]> https://biospectrumindia.com/news/22/10626/health-ministry-to-focus-on-oral-health-promotion.html https://biospectrumindia.com/news/22/10626/health-ministry-to-focus-on-oral-health-promotion.html Wed, 21 Mar 2018 10:35:00 +0530 Ashwini Kumar Choubey, Minister of State for Health and Family Welfare recently released the manual on oral health promotion for health workers and school teachers at a function to mark the World Oral Health Day. The manual encompasses the health, disease and prevention components and highlights the basic oral health care and the role of health workers and school teachers with respect to the common dental diseases.  The oral health manual for health workers is a comprehensive output for training frontline workers on oral health promotion as it familiarizes the frontline workers with features of healthy mouth. Preeti Sudan, Secretary (Health) stated that there is an urgent need to get these manuals translated in other languages so that people from other states can also benefit from it. The manual also connects the teachers to the parents and the communities at large, reiterating the concept of an Integrated School Community. She added that there shall be school health ambassadors under Ayushman Bharat programme to promote preventive health in schools. Also present at the function were Shri Dr. B.D. Athani, DGHS, Sh. Sanjeeva Kumar AS (Health), Sunil Kumar (Joint Secretary) along with other senior officers of the Ministry and AIIMS. ]]> https://biospectrumindia.com/news/22/10618/india-levies-protective-tariff-on-ofloxacin-imports-from-china.html https://biospectrumindia.com/news/22/10618/india-levies-protective-tariff-on-ofloxacin-imports-from-china.html Mon, 19 Mar 2018 12:25:00 +0530 India has levied anti-dumping duty on import of Chinese pharma product, used in the treatment of certain infections, to protect domestic producers from below-cost shipments.  The duty on import of ‘Ofloxacin’ from China will be in the range of $2.58 to $9.48 per kg for three years, said a notification issued by the Revenue Department in the Finance Ministry.  The levy has been slapped following the recommendations of the Directorate General of Anti-Dumping and Allied Duties (DGAD). Aarti Drugs had approached DGAD for initiation of anti-dumping investigation and imposition of duty on Ofloxacin imports.  After a probe into the imports, the Authority concluded that the product has been exported to India from China below its normal value, “resulting in dumping’’.  Countries carry out anti-dumping probe to determine whether their domestic industries have been hurt because of a surge in imports which are below the cost of producing them. As a counter measure, they impose duties under the multilateral regime of WTO.  The duty is aimed at ensuring fair trading practices and creating a level-playing field for domestic producers with regard to foreign producers and exporters. ]]> https://biospectrumindia.com/news/22/10611/government-mass-media-campaign-connects-tobacco-and-tuberculosis.html https://biospectrumindia.com/news/22/10611/government-mass-media-campaign-connects-tobacco-and-tuberculosis.html Fri, 16 Mar 2018 14:50:00 +0530 During the End-TB Summit in New Delhi, which Prime Minister Narendra Modi inaugurated on 13th March, The Ministry of Health and Family Welfare (MoHFW) has re-launched “Cough,” a national mass media campaign to warn citizens about the links between TB and tobacco use. “Cough” shows that tobacco consumption and exposure to secondhand tobacco smoke increases the risk of TB and of dying from the disease. A key barrier to timely diagnosis and treatment among smokers is the assumption that a cough is related to their smoking. This campaign encourages smokers to visit their doctor to confirm whether a persistent cough is a sign of TB.   TB killed 432,000 Indians in 2016 - more than 1,183 every day. The government aims to eradicate TB from India by 2025, five years ahead of the global TB elimination target of 2030. The campaign, which is designed to create support for TB eradication, encourage smokers to quit, and increase timely diagnosis and treatment of TB, was developed and implemented with technical support from Vital Strategies.    “Most TB deaths in India occur among young, economically productive adults and the disease is one of the top five causes of death among people aged 30-69 years,” said José Luis Castro, President and Chief Executive Officer, Vital Strategies. “India’s tobacco epidemic is contributing to this burden. “Cough” will support progress towards the target of eliminating TB by 2025 by encouraging smokers to quit and ensuring that smokers and those exposed to secondhand smoke visit the doctor about a persistent cough. This is a life-saving message and we congratulate MoHFW on the re-launch of this important campaign.”        When “Cough” first launched on World No Tobacco Day in 2017, India became the first country in the world to run a national tobacco control campaign that highlights the increased risk of TB and dying from TB linked to smoking tobacco (cigarettes or bidis) or exposure to second hand smoke. The public service announcement (PSA) graphically shows that while a smoker’s cough tells the smoker they have a health problem, a persistent cough over two weeks or more could indicate that problem is TB. The PSA shows a father smoking and coughing beside his daughter, noting that exposure to second-hand smoke brings the same risks. It ends with the stark warning that “Every bidi cigarette brings you and those around you closer to TB.” To ensure pan-India reach, “Cough” will be broadcast in 17 languages for ten days on the channels of public service broadcasters Doordarshan and All India Radio.  It will also run for two weeks on major digital platforms such as Youtube, Facebook, Hotstar and Voot and be supported by a social media campaign. In advance of its initial launch in 2017, “Cough” was rigorously pretested with a target audience who found that it was ‘easy to understand’, ‘believable’, ‘made respondents stop and think’, and ‘made respondents feel more concerned’ about smoking around others. The PSA also made respondents 'feel sympathetic to those with TB’, ‘made them feel concerned about symptoms of TB’, ‘made them more likely to visit a doctor if they had TB symptoms,’ and 'increased their confidence to take TB medications if they got sick.’ Overall, respondents understood the main message of the PSA and it resonated well with them. ]]> https://biospectrumindia.com/news/22/10597/icmr-receives-kochon-prize-for-tb-research.html https://biospectrumindia.com/news/22/10597/icmr-receives-kochon-prize-for-tb-research.html Thu, 15 Mar 2018 10:35:00 +0530 The Indian Council of Medical Research (ICMR) was recently awarded the International Kochon Prize 2017 for its contribution to the national programme in Tuberculosis research. The Kochon Prize is awarded annually by Stop TB Partnership to individuals or organizations that have made a significant contribution to combating tuberculosis. The award comprises prize money worth $ 65,000. The prize is given by the Kochon Foundation, a non-profit foundation registered in the Republic of Korea.  The ICMR through its TB Consortium accelerated the efforts for research and development on the terminal disease in the country. The consortium is working with both public and private institutes to guide India’s research efforts towards the development of point-of-care diagnostics, shorter treatment regimens and an effective vaccine for Tuberculosis. ]]> https://biospectrumindia.com/news/22/10592/pm-envisions-tb-free-india-by-2025.html https://biospectrumindia.com/news/22/10592/pm-envisions-tb-free-india-by-2025.html Wed, 14 Mar 2018 13:55:00 +0530 Launching the TB-free India campaign to eradicate the disease by 2025, Prime Minister has said that global efforts to eliminate tuberculosis have not been successful and stressed on changing the approach to achieve the goal. Modi said the government is moving ahead with the principle of "treat every TB patient best at the very first opportunity" and is roping in the private sector as well. He also called for multi-sectoral engagement and participation of all stake-holders at every level to create "TB-free village, panchayat, district and state", noting that frontline TB physicians and workers can make a major contribution in this direction. Holding that tuberculosis impacts lives, economy and the future of a nation, he said it is the poor who are worst affected by this communicable disease and every step taken towards eradicating tuberculosis is directly connected to their lives.The prime minister was speaking at the inauguration of the Delhi End-TB Summit here. Modi said the World Health Organisation had declared tuberculosis an emergency 25 years ago and since then several countries have made efforts to eliminate the disease."But the ground reality still remains that we have not been successful in curbing tuberculosis yet. If something doesn't yield desired results even after 10-20 years, then we need to change our approach and analyse the work done, which could help in finding new paths," Modi said. He launched the TB-free India campaign to take the activities under the National Strategic Plan for TB Elimination forward in a mission mode for eradicating the disease by 2025."A target has been set to end TB globally by 2030. I would like to announce that we have set aim to eradicate it from India five years ahead, by 2025," Modi said. State governments have a major role to play in elimination of TB from India, the prime minister said, adding he has written to all chief ministers to join this mission. The National Strategic Plan to eradicate TB by 2025 is operational and the government is constantly increasing budget for the schemes to counter the disease, he said. "The government has made a provision of spending USD 100 million per annum for providing nutrition support to the patients suffering from disease," he said. Listing out the steps taken by his government, Modi said flagship programmes like Swachch Bharat Abhiyan and providing LGP connections for a "smokeless kitchen" under Ujjwala Bharat Yojana will also reduce the dangers of contracting the disease. The prime minister said his government's thrust has been on technology and innovation in this field to better the drugs, diagnosis and treatment of the disease and to boost research, India TB Research Consortium has also been set up. Noting that TB is associated with social stigma and patients often hesitate to reveal their disease, Modi said that willpower is very critical to win over the disease.Targeting the previous governments, Modi said the immunisation programme has been going on for the last 30-35 years and despite this the country could not achieve the target of a complete coverage till 2014. "The pace of the immunisation coverage earlier was inching ahead by just a percent. Had we continued at with the same pace, it would have taken us another 40 years to achieve the target." However, in the last 3 to 3.5 per years it has increased by 6 per cent and by the next year, we will achieve 90 per cent immunisation coverage," he said. He also urged the Ministry of Health and Family Welfare to expand the ambit of research of traditional medicine in curing tuberculosis and share the results with other nations. Leaders from across the globe have converged in the national capital for the summit, hosted by the Union Ministry of Health along with the WHO and the Stop TB Partnership. TB was responsible for 1.7 million deaths in 2016, despite most cases being curable while over 10 million people contract TB every year. The summit would set the stage for the September 2018 United Nations High-Level Meeting on TB, where for the first time, TB would be discussed in the UN General Assembly at the Heads of State level.     ]]> https://biospectrumindia.com/news/22/10587/pm-envisions-tb-free-india-by-2025.html https://biospectrumindia.com/news/22/10587/pm-envisions-tb-free-india-by-2025.html Wed, 14 Mar 2018 11:15:00 +0530 Prime Minister Narendra Modi inaugurated the Delhi End TB Summit and launched the TB Free India Campaign recently. Shri J P Nadda, Union Minister of Health and Family Welfare, Smt Anupriya Patel, Minister of State for Health and Family Welfare, Dr TedrosAdhanom Ghebreyesus, Director-General, WHO, LucicaDifiu, Ex. Director, Stop TB Partnership along with the Health Ministers from 20 countries were also present at the inaugural function of the summit, which is being co-hosted by the Ministry of Health and Family Welfare, Government of India, WHO South East Asia Regional Office (SEARO) and Stop TB Partnership. The Prime Minister said that this event will always be known as a landmark event towards the elimination of TB in the World. “The global target for eliminating TB is 2030, but today I announce that the target for India to eliminate TB is 2025, five years before the global target,” the Prime Minister added. He further stated that TB mainly affects poorest of the poor and every step taken towards the elimination of this disease is a step towards improving the lives of the poor. Speaking at the function, DrTedros Adhanom Ghebreyesus, Director-General, WHO said that this is the right place to have this event and India’s plans to achieve the targets 5 years before the global target is bold, courageous and ambitious. Shri J P Nadda and DrTedros Adhanom Ghebreyesus, Director-General, WHO also chaired a session on   "Tracking Progress on Delhi Call to Action". ShriNadda also presided over a meeting with State Health Ministers. He highlighted the importance of active participation by the States through intense review and regular monitoring, to meet the time bound goal of ending TB by 2025. ]]> https://biospectrumindia.com/news/22/10580/moh-releases-revised-guidelines-for-gestational-diabetes.html https://biospectrumindia.com/news/22/10580/moh-releases-revised-guidelines-for-gestational-diabetes.html Sat, 10 Mar 2018 19:50:00 +0530 The Ministry of Health has released revised guidelines strengthening its stand on universal screening of all pregnant women for gestational diabetes mellitus (GDM). According to the report titled “Diagnosis and Management of Gestational Diabetes Mellitus” released recently, if the first prenatal test was found negative, a second test should be done at 24-28 weeks of gestation. Undiagnosed or inadequately treated GDM can lead to significant maternal and foetal complications. Moreover, women with GDM and their children are at increased risk of developing type 2 diabetes later in life. The new guidelines provide for creating a cadre of healthcare providers for medical nutritional threrapy and inclusion of oral drugs like metformin for control of sugar. According to the guidelines, States are free to choose the number of districts where the programme will be implemented initially, however all districts should be be covered in a phased manner. ]]> https://biospectrumindia.com/news/22/10575/who-introduces-plan-for-cheaper-tb-drugs.html https://biospectrumindia.com/news/22/10575/who-introduces-plan-for-cheaper-tb-drugs.html Fri, 09 Mar 2018 11:45:00 +0530 The World Health Organisation (WHO) has invited pharmaceutical companies around the world to submit proposals to manufacture affordable versions of newer medicines for treatment of drug resistant tuberculosis. WHO has now requested drug makers to submit an Expression of Interest (EoI) for Bedaquiline and Delaminid, two new-generation drugs, recommended for drug resistant-TB (DR-TB). Under WHO norms, drugs submitted upon such requests and complying with its standards are included in a list for procurement by the UN and other organisations. The EoI allows generics manufacturers interested in producing these two drugs, and currently facing technical challenges, to address their questions to WHO’s pre-qualification team. India has nearly 1.3 lakh DR-TB patients, the most in the world, but the Health Ministry gets only 10,000 doses of Bedaquiline and 400 doses of Delaminid. The medicines are obtained as donations from Janssen (US) and Otsuka Pharmaceuticals (Japan), the respective manufacturers. ]]> https://biospectrumindia.com/news/22/10562/telangana-govt-to-lift-life-sciences-sector-in-hyderabad.html https://biospectrumindia.com/news/22/10562/telangana-govt-to-lift-life-sciences-sector-in-hyderabad.html Wed, 07 Mar 2018 13:10:00 +0530 Industries and IT Minister K.T. Rama Rao said that the government has identified life sciences as a thrust area and is giving priority to research and innovation in pharma sector. It is working towards strengthening the life sciences ecosystem and exploring opportunities in the fields of digital medicine and artificial intelligence. According to Mr. Rao, Telangana is evolving in life sciences sector and state has huge scope for further industrial growth. The State government was keen on attracting new investments as well according gives priority to existing industries. There are also plans to set up an investment promotion body which will closely work with investors. Genome Valley, Hyderabad Pharma City and Medical Devices Park would make Hyderabad a unique destination for global life sciences industry. Mr. Rao said that an incubator similar to T-Hub is to be established at Genome Valley. ]]> https://biospectrumindia.com/news/22/10524/karnataka-govt-invests-rs-2177-cr-for-medical-education-research.html https://biospectrumindia.com/news/22/10524/karnataka-govt-invests-rs-2177-cr-for-medical-education-research.html Mon, 05 Mar 2018 10:15:00 +0530 A total of Rs. 2177 crore has been allocated by the Karnataka government, in order to boost medical education and research. This includes the construction of a 1,000 bedded additional ward in the Bangalore Medical College and Research Institute. On the heart care front, the government is committed to provide cardiovascular treatment facility at a cost of Rs. 7.81 crore at the Shimoga Super Speciality Hospital. A Cathlab facility will be established at Bidar Medical Sciences Institute and Gadag Medical Sciences Institute at an estimated cost of Rs. 15 crore each. For oncology, the government will establish a PET CT Scan facility at a cost of Rs. 15 crore at the Kidwai Cancer Institute, Bengaluru. A cancer treatment unit will also be established at an estimated cost of Rs. 15 crore each in Hassan, Mysuru and Karwar. In order to provide comprehensive medical training, the government is gearing up to build hospitals in medical colleges of Gadag, Koppal and Chamarajanagar and will spend Rs.100 crore each. A Burns Ward will be set up at the Kalaburgi Medical College with the grants from Hyderabad-Karnataka Development Region. The facilities in the nursing schools and colleges coming under the medical education department will be upgraded at an estimated cost of Rs. 30 crore. ]]> https://biospectrumindia.com/news/22/10519/government-to-hold-the-reins-for-medical-equipment.html https://biospectrumindia.com/news/22/10519/government-to-hold-the-reins-for-medical-equipment.html Fri, 02 Mar 2018 11:35:00 +0530 The government has decided to tighten the reins on ultrasound machines and similar imaging equipment in order to prevent companies from importing these products into India without proper registration. The move is also expected to ensure that these products follow high quality standards and are easier for the government to track in order to prevent abuse like the use of ultrasound machines for sex determination. The Drugs Technical Advisory Board (DTAB), the apex body advising the central drug regulator on technical matters related to drugs and cosmetics, has agreed to include these equipment as well as organ preservative solutions as medical devices under the purview of the country’s existing drug regulations. This is with an aim to regulate the import, manufacture, distribution and sale of these products. Companies would now have to take permission from the Central Drugs Standard Control Organisation (CDSCO), the central drug regulator, to import these products into India. ]]> https://biospectrumindia.com/news/22/10518/telangana-govt-tata-trusts-team-up-for-cancer-care.html https://biospectrumindia.com/news/22/10518/telangana-govt-tata-trusts-team-up-for-cancer-care.html Fri, 02 Mar 2018 11:15:00 +0530 The Telangana government and Tata Trusts have signed a Memorandum of Understanding (MoU) to deliver high quality affordable cancer care through a three-tier model and develop academic and research capabilities in the state. The MoU was signed by A Santhi Kumari, Telangana Principal Secretary, Health, Medical and Family Welfare Department, and R Venkataramanan, Managing Trustee, Tata Trusts. According to the agreement, two apex super-speciality hospitals in the city- the MNJ Institute of Technology and the Nizam Institute of Medical Sciences will be upgraded to handle complex cancer cases on a referral basis. Medical colleges in Adilabad, Nizamabad, Mahbubnagar and Warangal will be strengthened to offer diagnosis and treatment of cancer cases. The initiative in Telangana is the latest in Tata Trusts' effort to partner with state governments and other entities to decentralise cancer care in India. Similar initiatives are in different stages of implementation in Assam, Maharashtra and Uttar Pradesh. ]]> https://biospectrumindia.com/news/22/10517/karnataka-govt-launches-umbrella-brand-for-tech-revolution-in-state.html https://biospectrumindia.com/news/22/10517/karnataka-govt-launches-umbrella-brand-for-tech-revolution-in-state.html Thu, 01 Mar 2018 19:45:00 +0530 Karnataka has been the torchbearer for innovation and technology in India but it’s not enough, believes the state government led by Chief Minister Mr Siddaramaiah. The government is working to make the state a global first choice for innovation, and in an effort to realise this dream, the Chief Minister has unveiled ‘Innovate Karnataka’ in Bengaluru. ‘Innovate Karnataka’ will act as an umbrella brand for all innovation in the state whether it’s in emerging technologies such as blockchain, robotics, artificial intelligence (AI), nanotechnology, etc, or in the vibrant startup ecosystem that has become a part of the new, young and exciting identity of Karnataka.    Unveiling the brand narrative for ‘Innovate Karnataka’, the Chief Minister Mr Siddaramaiah said, “Development cannot happen without innovation, and no innovation is truly big unless it helps people. With ‘Innovate Karnataka’, we hope to start on the path to Mission 2025: where technology will help in the inclusive development of the state, where better governance can be delivered to the citizens."    “Our vision is to put people first in all our schemes in programmes, and ‘Innovate Karnataka’ will both fulfill the vision, and be a driving force for it,” he added.   The vision of ‘Innovate Karnataka’ is: “To see Karnataka as a global first choice of innovation and technology by adopting policies which spur 100% digitization of health, agriculture and other domains and enable inclusive digital growth across geographies and all strata of society.”   The brand was launched with an eye on the future, by a government mindful of evolving with the times. Which is why, ‘Innovate Karnataka’ will be spearheaded by the Department of Innovation and Technology. A modern, more advanced version of the Department of IT, BT.   The Department of Information Technology was carved out of from Department of Commerce and Industry in 1998, thereby enabling IT to gain more prominence across the State. The Government also understood the promise Biotechnology held, and subsequently established the Department of Information Technology & Biotechnology in September 2001. But the industrial and economic landscape is changing and new problems are cropping up. These new problems need new solutions. The future will be defined not by the IT services, which lead the growth of IT, but through a fusion of physical, digital and biological worlds.   Speaking about the convergence of various technologies, and the need for putting innovation first, Mr Priyank Kharge said, “We are at the cusp of a technology revolution across the world, and Karnataka is poised to be the global leader when it comes to innovation. Already, we are spearheading the startup movement in India, and ensuring that we’re at the forefront of blockchain, nanotechnology, artificial intelligence innovation. Now, it’s time to take Karnataka into a safe, secure future where technology solves real problems.”   The government also launched several Centres of Excellence (CoE) across Karnataka at the programme, including the Centre of Excellence for Data Science and Artificial Intelligence, in association with NASSCOM; Centre of Excellence for Machine Learning & Robotics at IIITB amongst others. ]]> https://biospectrumindia.com/news/22/10514/delhi-commemorates-rare-disease-day.html https://biospectrumindia.com/news/22/10514/delhi-commemorates-rare-disease-day.html Thu, 01 Mar 2018 15:55:00 +0530 On the occasion of Rare Disease Day, Lysosomal Storage Disorders Support Society (LSDSS), a patient group association for Lysosomal Storage Disorders (LSDs) organised a rare disease awareness event in Delhi. The aim was to raise awareness about rare diseases, specifically LSDs, and its different aspects and to support the rare diseases community at large. The event was also a platform for applauding the national policy for rare diseases and to discuss the steps ahead to expedite the process of its implementation. Lav Agarwal, Joint Secretary, MoH&FW who spearheaded the formulation and the finalization of the policy, Dr. Madhulika Kabra (Unit of Genetics, AIIMS), Dr. Seema Kapoor (Associate Professor, Department of Pediatrics, Maulana Azad Medical College) and patients in Delhi suffering from LSDs were present at the event. Commenting on the event, Manjit Singh said, “Rare diseases, being uncommon, have seldom been considered as a major health issue. However, the commemoration of Rare Disease Day through events like these would ensure that rare diseases are given their due recognition. Moreover, our efforts have finally seen the light of the day with the finalization of the national rare disease policy which clearly showcases that the emphasis has been put on this healthcare challenge. Now its effective and swift implementation is crucial to ensure that the patients can avail its maximum benefit. Further, state being a health subject, it is important for the state government to take steps to draft its individual policy.” Lav Agarwal said, “With the National Policy for Treatment of Rare Diseases being finalized, we are happy that our efforts have been acknowledged. There is a sort of satisfaction, although minimum, that the issue of rare diseases is now on the national front. The Rs. 100 crore fund is an element of hope and for the same we have proposed the formation of two committees- Technical and Administrative. These committees would initiate the process of identifying patients and providing them treatment. Moreover, to make the process less cumbersome, there would be a web-based application process where the patients can apply directly and from thereon it would be the responsibility of the centre and state governments to provide them treatment. The policy is a first step and it would be a matter of sometime before it gets implemented since it requires the coordination of all the concerned members and committees.” Although rare, the number of patients suffering from such disorders is substantial considering the population of the country. This event being held on the occasion of rare disease day is the most appropriate way to highlight the various needs of the patients and also to showcase how treatment can have a positive impact on a patient’s life, especially in the case of LSDs. Further elaborating, Dr. Seema Kapoor said, “The patients suffering from LSDs often lead chronic, debilitating lives and are not able to do even simple daily tasks. What is further disturbing is the fact that the majority of the patients suffering from LSDs are children. Certain concrete measures in the form of a strong rehabilitation and support treatment system along with the genetic counselling in high risk patients would be helpful in overcoming the diagnostic and treatment challenges.” The event was also a platform for the patients to discuss their individual challenges and journey. It served as an opportunity for them wherein they were able to draw inspiration from each other’s struggles and positive stories.     ]]> https://biospectrumindia.com/news/22/10510/usfda-approves-zydus-cadilas-sedative-injection.html https://biospectrumindia.com/news/22/10510/usfda-approves-zydus-cadilas-sedative-injection.html Thu, 01 Mar 2018 11:55:00 +0530 Zydus Cadila provides total healthcare solutions ranging from formulations, active pharmaceutical ingredients and animal healthcare products to wellness products. The company has received final approval from US health regulator to market Dexmedetomidine Hydrochloride injection used for sedation of intubated and mechanically ventilated patients. The approval from USFDA is to market Dexmedetomidine Hydrochloride injection 200 mcg (base)/ 2 ML and 100 mcg (base)/ ML single dose virals. The injection will be manufactured at the group's formulations manufacturing facility at Moraiya, Ahmedabad. The drug is indicated for sedation of intubated and mechanically ventilated patients during treatment in an intensive care setting and for sedation of non-intubated patients prior to and/or during surgical and other procedures. ]]> https://biospectrumindia.com/news/22/10492/dcgi-to-support-pharma-innovations-and-startups.html https://biospectrumindia.com/news/22/10492/dcgi-to-support-pharma-innovations-and-startups.html Tue, 27 Feb 2018 11:45:00 +0530 The Drugs Controller General of India (DGCI) is planning to set up a dedicated cell for supporting and regulating innovation and start-ups in the pharmaceutical sector in the country. According to the DCGI, there are many start-ups which are coming in the pharma and allied segments and are clueless about regulations. As a result, they face a lot of problems. Since many innovators are scientists and researchers, they do not have much knowledge of drug regulations and procedures to handle it. There is a need to bridge this gap. The DCGI feels that innovators need to know about the regulatory framework they have to comply with for market authorization or commercialisation of their products. The tentative time period for setting up of the new innovation support and regulatory cell will be 2-3 weeks period and it is expected to come up at the office of the Central Drugs Standard Control Organization in New Delhi. ]]> https://biospectrumindia.com/news/22/10487/shantha-biotechnics-receives-who-approval-for-cholera-vaccine.html https://biospectrumindia.com/news/22/10487/shantha-biotechnics-receives-who-approval-for-cholera-vaccine.html Mon, 26 Feb 2018 17:55:00 +0530 Shantha Biotechnics, a wholly-owned subsidiary of one of the world’s largest pharma company Sanofi group, has received approval from the World Health Organisation (WHO) for its oral cholera vaccine Shanchol which eliminates the challenges of maintaining the vaccine cold chain between 2 and 8 degrees to maintain vaccine potency during transport. Shanchol cholera vaccine is the second mass campaign vaccine and first cholera vaccine worldwide to receive such a stamp of approval for storage and distribution outside the traditional cold chain. It is majorly used for prevention and control of cholera in outbreak, endemic settings during humanitarian crises. According to the company, WHO’s approval will help to make Shanchol available to populations living in remote, hard-to-reach areas of India and other parts of the world, especially ones with erratic electricity supply. Since WHO pre-qualification in 2011, 12 million doses of Shanchol vaccine have been shipped to 25 countries across the world, including Democratic Republic of the Congo, Haiti, Mozambique and South Sudan. ]]> https://biospectrumindia.com/news/22/10475/pharmacist-requests-to-modify-pharmacy-act-to-ban-doctors-from-dispensing-drugs.html https://biospectrumindia.com/news/22/10475/pharmacist-requests-to-modify-pharmacy-act-to-ban-doctors-from-dispensing-drugs.html Mon, 26 Feb 2018 11:50:00 +0530 Professional expert in pharmacy from Kerala has demanded to the Pharmacy Council of India (PCI) to act on a resolution passed unanimously by the Central Council of PCI in December last year demanding amendment of Section 42 of the Pharmacy Act.  The resolution was moved for amending clause 1 of section 42 of the Pharmacy Act, which permits medical practitioners to dispense medicines to their own patients. Medical practitioners are unregistered pharmacists; hence they are not eligible to dispense drugs. Rajan B Rajan, former president of Kerala State Pharmacy Council (KSPC) had moved a resolution in the Central Committee of the PCI in December last year and it demanded repeal of the clause 1 in the section 42 which allows medical practitioners to dispense medicines to their own patients. With the special sanction of the government, they are also allowed to dispense medicines to the patients of another medical practitioner. This provision to permit unregistered pharmacists to dispense medicines should be quashed. Resolution of Rajan further wants the PCI that the term ‘prepare’ should be deleted from the clause and insert the term ‘manufacture’ in place. According to him, till forty years ago most of the medicines were imported from other countries and the formulations were made here by compounders and doctors. The situation has changed now and we are manufacturing all kinds of drugs in the country. So, pharmacists should be given the right to manufacture medicines.  Government has now given instructions to PHCs to dispense medicines to the patients of non-communicable diseases (NCD) reaching sub-centres, under supervision of doctors. NCD patients are given medicines through sub-centers and are no pharmacist is working there. ]]> https://biospectrumindia.com/news/22/10463/up-govt-step-forward-to-expand-pharma-biotech-sector-.html https://biospectrumindia.com/news/22/10463/up-govt-step-forward-to-expand-pharma-biotech-sector-.html Fri, 23 Feb 2018 13:25:00 +0530 Anupriya Patel, Union minister of state for health and family welfare said the present state government is serious about development of pharmaceutical and biotechnology sector.  Addressing the special plenary on pharmaceutical and biotechnology on the first day of UP Investors Summit, Patel said, "The summit will pave the path for development in the state. Development of UP will speed up development of the country."  UP minister for Medical and Health, Siddharth Nath Singh said that effective steps are been taken to promote healthcare and pharmaceutical sector in the state.  He added that 34 investors have signed MoUs of Rs 6,970 crore for this sector during the summit. From these, MoUs of Rs 5,743 crore has been signed under the healthcare sector and MoUs of Rs 1,227.55 crore for pharmaceutical sector.  He said that healthcare centres will be set up in Greater Noida, near Yamuna Expressway, Lucknow, Mathura, Ghaziabad and Moradabad.  The pharmaceutical units will be set up in Lucknow, Moradabad, Noida, Jhansi, Hamirpur, Sitapur, Kushinagar, Lakhimpur Kheri and Meerut. ]]> https://biospectrumindia.com/news/22/10462/nilekani-to-assist-healthcare-scheme-development.html https://biospectrumindia.com/news/22/10462/nilekani-to-assist-healthcare-scheme-development.html Fri, 23 Feb 2018 12:00:00 +0530 Tech billionaire Nandan Nilekani will be assisting the government in developing IT infrastructure for the mega National Health Protection Scheme (NHPS), which seeks to cover 10-crore families. The IT infrastructure for the healthcare scheme will be of a huge scale as was required for Aadhar and will have to be scaled up gradually in view of the massive range of the programme. The NHPS will require large-scale IT infrastructure for a smooth and effective roll-out as it is aimed at covering over 10 crore poor and vulnerable families (about 50 crore beneficiaries). ]]> https://biospectrumindia.com/news/22/10448/5th-global-forum-on-tb-vaccines-call-to-accelerate-global-funding-on-tb-vaccine-research.html https://biospectrumindia.com/news/22/10448/5th-global-forum-on-tb-vaccines-call-to-accelerate-global-funding-on-tb-vaccine-research.html Wed, 21 Feb 2018 14:40:00 +0530 The 5th Global Forum on TB Vaccines recently commenced in New Delhi. The Forum is a scientific conference, which provides a platform for researchers, clinicians, product developers, policy makers, advocates, and other stakeholders, to review the state of the field, share the latest research and findings with the end goal of developing new TB vaccines. Experts agreed that there is an urgent need to develop an effective vaccine against both drug-sensitive and drug-resistant (Multi Drug Resistant and Totally Drug Resistant) TB. The target set forth in the WHO End TB Strategy to end the TB epidemic by 2035 cannot be achieved without new vaccines, as well as improved diagnostics and treatment. The Inaugural Ceremony was attended by the Anupriya Patel, Minister of State for Health and Family Welfare; Dr. Soumya Swaminathan, Deputy Director General (Programmes), World Health Organization; Dr. Ashutosh Sharma, Secretary, Department of Biotechnology; Preeti Sudan, Ministry of Health and Family Welfare and other key dignitaries. Anupriya Patel, Minister of State for Health and Family Welfare said, “A crucial pillar of the Government of India’s TB elimination response, is the increased focus on R&D. We recently established the India TB Research Consortium to drive TB R&D efforts in the country. The consortium is working with public and private institutes, to guide the country’s research efforts towards the development of point-of-care diagnostics, shorter treatment regimens and an effective vaccine. We are confident that this forum will accelerate efforts and we hope to see a new TB vaccine is the near future.” The Forum is convened under the aegis of the Stop TB Partnership Working Group on New Vaccines. The organizing partners for the forum include the Government of India’s Department of Biotechnology (DBT), Translational Health Science and Technology Institute (THSTI), Indian Council of Medical Research (ICMR) and International organizers, Aeras and the TuBerculosis Vaccine Initiative (TBVI), both of which are non-profit organizations, facilitate the development of new, effective TB vaccines that are affordable and accessible. R&D is one of the pillars of the WHO’s End TB Strategy and will play a pivotal role in achieving global elimination targets. However, a recent analysis indicates that globally, none of the key research areas i.e., drugs, vaccines, diagnostics and operational research achieved the recommended levels of funding outlined in the Global Plan to Stop TB 2011-2015. Global funding for TB R&D in 2015 was $621 million (₹ 4,252 crores) - its lowest level since 2008. While the Global Plan to End TB, 2016-2020, calls for annual investments of $250 million in TB vaccine research, vaccine R&D experienced the greatest decrease in funding from previous years, receiving only a little over $80 million in 2015. Dr. Soumya Swaminathan, Co-Chair of the 5th Global Forum said, “The WHO End TB Strategy recognizes the centrality of accelerating TB R&D efforts, especially for the development of an effective TB vaccine, to achieve our TB elimination efforts. Considering the country’s expertise and experience in developing affordable and effective vaccines, the large number of young scientists, and the government’s push for indigenous product development, it is appropriate that the Global Forum has chosen India as the venue for this conference, and we’re glad to witness such large scale participation.” The existing TB vaccine, the BCG (Bacille Calmette-Guerin) vaccine dates back to the 1920s. The nearly hundred year old vaccine is moderately effective in preventing severe forms of TB in children, particularly TB meningitis, but it does not adequately protect adolescents and adults, who are at highest risk for developing and spreading TB. It is therefore important that a vaccine is developed, which could prevent adolescents and adults from acquiring, developing or spreading the disease and would be the single most cost-effective tool in mitigating this epidemic. Globally, there are 12 TB vaccines in various stages of clinical trials, with many more candidates and concepts in earlier stages of development. The Global Forum on TB Vaccines is the world’s largest gathering of stakeholders striving to develop new vaccines to prevent TB. It provides an important and unique opportunity to review the state of the field, share the latest research findings, and identify new and innovative approaches to TB vaccine R&D, with the end goal of developing and deploying new TB vaccines as quickly as possible. The Forum is a scientific conference, which provides a platform for researchers, clinicians, product developers, policy makers, advocates, and other stakeholders, to review the state of the field, share the latest research and findings with the end goal of developing new TB vaccines. Dr. Ashutosh Sharma said “In terms of vaccines, India has progressed from being one of the world’s top vaccine-manufacturers to become an emerging player in the R&D of vaccines. The DBT is supporting TB initiatives in a major way by setting up Regional Prospective Observational Research for Tuberculosis (RePORT) India Consortium under the aegis of Indo-US Vaccine Action Programme, to enhance or build, combined biomedical and clinical research capacity in India. It is a matter of pride that India makes more than 60% of the world’s vaccines and are in the right direction to become a hub for vaccine R&D as well.” Tuberculosis kills more people than any other infectious disease. Globally, 17 lakh people lost their lives to TB in 2016. India accounts for almost 27% of the global TB burden. There were an estimated 28 lakh new cases of TB in India in 2016, with 4.52 lakh people succumbing to the disease, including those with TB and HIV. Multidrug-resistant (MDR) and extensively drug-resistant (XDR) TB are more severe forms of TB. MDR and XDR are difficult and expensive to treat, and have high mortality rates. India had an estimated 1.47 lakh drug resistant TB cases in 2016. Preeti Sudan said, “In the past few years, the Government of India has introduced several progressive policy changes which have transformed the way we diagnose and treat TB. However, in order to achieve our elimination targets, we recognize the importance of an effective vaccine and have therefore introduced supportive initiatives to drive TB vaccine R&D. We are glad that the Global Forum is being organized in India and we hope to have a fruitful and productive conference.”  ]]> https://biospectrumindia.com/news/22/10438/icmr-drafts-policy-to-safeguard-medical-records.html https://biospectrumindia.com/news/22/10438/icmr-drafts-policy-to-safeguard-medical-records.html Tue, 20 Feb 2018 14:00:00 +0530 The National Centre for Disease Informatics and Research (NCDIR), Bengaluru, under ICMR, has developed a draft policy on data processing and disclosure that aims to protect patient confidentiality and privacy in disease registries. The registry data comes from hospitals and laboratories and are extracted from medical records, pathology reports, radiotherapy charts etc. that have been collected for several years. ICMR has mandated that the data will only be used for research purposes or in the larger public interest. The third party, i.e. legal person, public agency or any other body, shall use the data strictly in compliance with the terms of the policy, and cannot further share or transfer the data with any other individual or organization within or outside India. Only after ICMR-NCDIR approval shall this research be released for publication. According to ICMR, such a policy is much needed. In the near future, there may be a statutory mandate for hospitals and other sources to supply data on non- communicable diseases such as cancer, cardiovascular diseases, diabetes, stroke to the ICMR-NCDIR. ]]> https://biospectrumindia.com/news/22/10422/dinesh-arora-joins-as-director-for-pms-healthcare-programme.html https://biospectrumindia.com/news/22/10422/dinesh-arora-joins-as-director-for-pms-healthcare-programme.html Fri, 16 Feb 2018 11:40:00 +0530 Dinesh Arora, director (health) at federal policy think tank Niti Aayog, has been appointed director of the prime minister’s flagship healthcare programme, Ayushman Bharat, in the health ministry. Arora had been working on the programme for more than a month before it was announced in the budget speech by finance minister Arun Jaitley on February 1. He is a qualified doctor and has worked in public health in the past, heading the National Rural Health Mission in Kerala from May 2006 to September 2009. He moved to Niti Aayog in July. Union health ministry’s additional secretary, Manoj Jhalani, has been appointed mission director of the project. Both Arora and Jhalani in different capacities have been involved in government’s flagship programme — National Health Mission (NHM) — which has several key health initiatives under it, including Mission Indradhanush. ]]> https://biospectrumindia.com/news/22/10414/bengaluru-hosts-the-biggest-annual-conference-on-pharma-industry-medical-devices.html https://biospectrumindia.com/news/22/10414/bengaluru-hosts-the-biggest-annual-conference-on-pharma-industry-medical-devices.html Thu, 15 Feb 2018 16:05:00 +0530 Union minister of Chemicals & Fertilizers and Parliamentary Affairs Mr. Ananthkumar stated that the Ayushman Bharat insurance scheme announced by the Government, popularly dubbed Namo-Care, has the potential to turn India into the largest pharma manufacturer of the world in about three years. Inaugurating the third edition of India Pharma 2018 and India Medical Device 2018, the dual conferences and exhibitions being organized by FICCI in collaboration with Dept. of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, Govt. of India, Mr. Ananthkumar said: “Ayushman Bharat will fundamentally change Indian healthcare. It is laying down an ambitious framework for Universal Health Coverage. The Government will start rolling out Namo-Care in the next two months with the same speed and efficiency as highly successful initiatives like Mudra Yojana, Ujjwala Yojana, Ujala Yojana and neem coating of urea.” The minister pointed out that Namo-Care cannot be effectively implemented in the currently fragmented ecosystem of the pharma industry and the Government accordingly intended to come up with a new pharma policy which will unify and synergize its various components such as Drug Price Control Order (DPCO), manufacturing, R&D, financing, quality control, drug control, price control and medical devices. The pharma and medical devices industry must take up the Namo-Care challenge, he said. “I have given it the triple A formula – Availability, authenticity and affordability. Can we produce affordable pharma products and medical devices of global standards? That is the real challenge,” added Mr. Ananthkumar. The minister also said that the country needed a new ministry of Pharma and Medical Devices as various parts of the industry currently were under the ambit of different ministries, leading to fragmentation and lack of unity of purpose. “Considering the demand of the industry, we are also going to undertake major reforms in the DPCO,” he stressed. A host of dignitaries were present at the inaugural ceremony of the three-day mega-event, including Shri Mansukh L Mandaviya, Hon’ble Minister of State for Chemicals & Fertilizers, Govt. of India, along with the Who’s Who of the pharma and medical devices industry and government officials from India and abroad. Hundreds of delegates, including 50 Hosted Delegates from other nations and over 10,000 business visitors, are attending the event. Over 300 companies and 50 start-ups are showcasing their products. More than 90 eminent industry leaders would speak at various sessions spread over three days. Addressing the audience, Shri Mansukh L Mandaviya, Hon’ble Minister of State for Chemicals & Fertilizers, said: “Rapid growth in the pharma industry, especially in bulk drugs and APIs, is essential to meet the health needs of the masses. The Indian pharma market is set to emerge as the sixth largest pharma market globally by 2020. The pharma exports stood at US $16.8 billion in 2016-17 and are expected to grow by 30% over the next three years to reach US $20 billion by 2020. Indian companies received 305 ANDA approvals from the US FDA in 2017. Our focus is to promote upcoming therapies and provide a conducive environment for them to flourish. We want to regulate various complex issues related to pricing and availability of medicines at affordable prices, R&D, and protection of IPR.” Over 20 international drug and device regulators are set to meet with Indian regulators at the venue. Ministerial delegations from CIS and BIMSTEC countries are also attending the event. A key highlight of India Pharma & India Medical Device 2018 is a workshop by World Health Organization on “Regulatory System Strengthening and Prequalification updated by WHO.” A conference will also be organized by NASSCOM on “Digital Transformation through Innovation in Pharmaceutical, Medical Devices and Healthcare Industries.” The event will see a roundtable of pharma and medical devices CEOs with the Union Minister of Chemicals & Fertilizers, Mr. Ananth Kumar, to discuss Government policy and challenges facing the industry. India Pharma & India Medical Device Awards were announced at the event to honour excellence and innovation in the field of pharmaceuticals and medical devices. Themed around ‘Affordable, Quality Healthcare,' the three day conference has back to back sessions to discuss topics like Discovering Innovative Medicines in India; Making India a Part of Global Supply Chain in Medical Devices; Opportunities, Challenges and Regulatory Requirements in the Development of Biologics; Opportunities & Challenges for Stem cells & Regenerative Medicine; Emerging Global Trends in Self Care and Relevance of OTC Regulatory Framework for Indian Public Healthcare System; a Sub-sectoral Approach to Make in India; and Moving towards API Self Sufficiency. This is the third time that Karnataka is hosting this co-located conference on Medical Device & Pharmaceutical sector. The state pharma industry constitutes 264 manufacturing units, providing direct employment to 25,000 people. Karnataka stands 5th in Pharmaceuticals exports with 40% of its pharma produce being exported overseas. ]]> https://biospectrumindia.com/news/22/10408/government-initiates-to-help-biotech-startups.html https://biospectrumindia.com/news/22/10408/government-initiates-to-help-biotech-startups.html Wed, 14 Feb 2018 17:15:00 +0530 The ministry of government has come forward to set up 15 new biotechnology start up along with another 15 new technology business incubator. According to Minister for Science and Technology and Earth Sciences, Dr. Harsh Vardhan, apart from the incubators, the Biotechnology Industry Research Assistance Council (BIRAC) will support setting up of 3,000 additional start-ups in different parts of the country.  The allocation for Department of Science and Technology (DST) for the last five years has witnessed a whopping 90 percent increase over preceding five years (2009-10 to 2013-14), followed by a 65 percent increase for Department of Biotechnology (DBT), 43 percent for Council of Scientific and Industrial Research (CSIR) and 26 percent for the Ministry of Earth Sciences (MoES). He noted that CSIR, as well as DST, DBT and MoES, have been allocated more funds this year. The increase is eight percent for DST, 3.56 percent for CSIR, 6.7 percent for DBT, and 12.7 percent for MoES. ]]> https://biospectrumindia.com/news/22/10395/j-p-nadda-launches-national-deworming-initiative-.html https://biospectrumindia.com/news/22/10395/j-p-nadda-launches-national-deworming-initiative-.html Tue, 13 Feb 2018 16:25:00 +0530 J P Nadda, Union Minister of Health and Family Welfare launched the National Deworming Day at a function at Gurugram recently. Speaking on the occasion he said, “Government of India is committed to ensuring high quality healthcare, accessible to every child and upto the last mile. One of the interventions, the National Deworming Day, is one of the largest public health initiatives in the world.” Rao Inderjit Singh, Minister of State- Chemicals & Fertilizers, Rao Narbir Singh, PWD Minister, Govt. of Haryana and Manoj Jhalani, AS & MD (NHM), Amit Jha, Principal Secretary (Health & Family Welfare), Govt. of Haryana, Amneet P Kumar, MD(NHM), Department of Health and Family Welfare, Government of Haryana and other senior officers of the Union Health Ministry and from the Government of Haryana were also present at the event. Speaking at the function, the Union Health Minister announced that for this round of National Deworming Day, the Government is aiming to reach more than 32.2 crore children. He further stated that the Ministry had first launched National Deworming Day (NDD) in 2015 which was implemented in 11 States/UTs across all Government and Government-aided schools and Anganwadi centres targeting children aged 1 to 19 years. Since then the program has been scaled up throughout the country. Shri Nadda further informed that last year 25.6 crore children in the February 2016 round and 22.8 crore children in the August 2016 round were successfully reached and treated with deworming treatment on National Deworming Day. He also released the ‘Deworming Factsheet’ at the event. Speaking at the function, Nadda said that the government prioritizes the wellbeing of children no matter which part of the country they live in and what their circumstances are. “We follow a life-cycle approach in devising all our health programs, right from pregnancy till adolescence, we take care of the mother and the child to make them healthier and get their timely access to healthcare. Our programs like National Deworming Day, which is for all children, are ensuring prevention of cognitive disability as well decreasing the school drop-out rate of children by improving overall health of the children. All these initiatives move us closer to overall wholesome development of the country,” he added. Urging all the stakeholders to come forward and participate in this initiative, Nadda stated that the aim of a worm-free India can be true only if we all join hands to make this program a success. “I would request all health functionaries and health leaders to participate in the program and see to it that we make this program a success. Also I salute all our healthcare workers who have ensured the reach of this program to the grass root level”, he said. He also urged all stakeholders and especially all public representatives to talk, generate awareness and discuss about health, as it is an very important factor in development of the country. Nadda said, “The National Deworming Day will mobilize health personnel, state governments and other stakeholders to prioritize investment in control of Soil Transmitted Helminth (STH) infections—one of the most common infections.” Further he said, “It aims to create mass awareness about the most effective and low-cost STH treatment— administering Albendazole tablets. The tablet has no side effects and in case the dose gets missed, MoHFW carries out ‘mop-up’ sessions, to ensure no child is left out. Along with Albendazole administration, behaviour change practices in terms of cleanliness, hygiene, use of toilets, wearing shoes/chappals, washing hands etc. is also important to reduce incidents of re-infection.” The National Deworming Day is a single fixed-day approach to treating intestinal worm infections in all children aged 1- 19 years. Having conducted five rounds of National Deworming Day since February 2015, the mass deworming program aims to reach all children at schools and anganwadis with the deworming treatment. Any child not dewormed on National Deworming Day due to absenteeism or sickness, will be dewormed on mop-up day, 15 February. Anganwadi and school-based mass deworming program is safe, cost-effective, and can reach crores of children quickly. Deworming has been shown to reduce absenteeism in schools; improve health, nutritional, and learning outcomes; and increase the likelihood of higher-wage jobs later in life. Deworming with the safe and beneficial Albendazole tablet is an evidence-based, globally-accepted, and effective solution to controlling worm infections. To prepare for National Deworming Day, teachers and anganwadi workers have been trained to administer the tablet to children, while ASHAs and other functionaries will generate awareness and mobilize children to be dewormed on the day. Other ministries and departments from Panchayati Raj, Youth affairs are also deploying their resources of panchayat members, youth volunteers and other community-based groups to engage communities towards a worm free India. The first AMRIT pharmacy for the state of Haryana was also inaugurated by the Minister of Health and Family Welfare at the event. ]]> https://biospectrumindia.com/news/22/10392/ccrum-organises-international-conference-on-unani-medicine-.html https://biospectrumindia.com/news/22/10392/ccrum-organises-international-conference-on-unani-medicine-.html Tue, 13 Feb 2018 14:05:00 +0530 Two day International Conference on Unani Medicine was recently organised by the Central Council for Research in Unani Medicine (CCRUM) as a part of Unani Day recently in New Delhi. It was inaugurated by Dr Jitender Singh, Minister of State (IC), Ministry of Development of North Eastern Region, MoS PMO and D/o Atomic Energy and Space. While inaugurating the event he said, ‘Lifestyle diseases are one of the major health challenges of the country, an area where integration of traditional and conventional medicine systems can play an important role.’ Dr. Singh emphasized all-round development of indigenous systems of medicine with special focus on holistic management of diseases. He opined that all the physicians irrespective of system of medicine whether modern or traditional may be co-located for addressing the requirement of patients in holistic manner. Talking about Hakim Ajmal Khan, whose 150th Birth Anniversary on 11th February is being celebrated as Unani Day; he said that contribution made by him to the traditional medicine and to the nation was remarkable.   On this occasion, a MoU was signed between CCRUM and Hamdard University, Bangladesh to establish an “academic chair” in Unani System of medicine in Bangladesh. Hamdard University was represented by Dr. Abdul Mannan, Vice Chancellor. The aim of this MoU is to provide academic leadership to the institution, primarily through demonstrating and fostering excellence in teaching, research, and policy development related to Unani system of medicine at the varieties of levels within the discipline. In two day conference various national level eminent personalities and stakeholders from academia, industry, regulators, and researchers in the field of Unani Medicine are participating in deliberations. Besides national delegates, representatives from countries like South Africa, UK, Sri Lanka, Bangladesh, China, USA, Portugal, UAE, Slovenia, Israel, Hungary, Bahrain, Tajikistan, etc were also present at the conference. Speaking on the occasion, Pramod Kumar Pathak, Joint Secretary, Ministry of AYUSH said that this international conference which is themed on Integration of Unani Medicine in Mainstream Healthcare is in line with the objectives of the ministry towards mainstreaming of AYUSH in national healthcare. Roshan Jaggi, Joint Secretary, Ministry of AYUSH in his address highlighted the efforts being made by the Ministry of AYUSH to promote rational medicine in national public health system through regulation of research and appropriate integration of quality products, practices, and practitioners into the health system so as to achieve universal health for all. Addressing the conference, Hakim Syed Khalifatullah, former Vice President, Governing Body, CCRUM demanded that A&U Tibbia College should be upgraded as a national university of Unani Medicine. He emphasized that there should be a strong coordination between Medical Council of India and Central Council of Indian Medicine to come up with an integrative solution to address health challenges of the country. Prof. Rais-ur-Rahman, Advisor (Unani), Ministry of AYUSH said that National Health Policy 2017 has been designed to ensure access to AYUSH remedies through co-location in public health facilities. Further, he said that the policy recognizes the need to standardize and validate Unani medicines and establish a robust and effective quality control mechanism for ASU & H drugs. Earlier in his welcome address, Dr. Anil Khurana, Director General, CCRUM briefed about the background behind organizing International Conference on the occasion of Unani Day. Keeping in view, the need for integration of various systems of health, it is essential to discuss and develop a strategy in this regard. ]]> https://biospectrumindia.com/news/22/10384/naco-partners-with-metropolis-healthcare-for-hiv-viral-load-testing.html https://biospectrumindia.com/news/22/10384/naco-partners-with-metropolis-healthcare-for-hiv-viral-load-testing.html Mon, 12 Feb 2018 16:30:00 +0530 Metropolis Healthcare Ltd was recently awarded the contract by NACO, Ministry of Health, and Government of India to conduct HIV Viral Load testing for patients across 525 antiretroviral therapy (ART) centres in the country, bringing about a sweeping change in treating HIV patients in the country. This initiative has begun from 8 th February 2018. Through this game-changing initiative by the government, NACO and Metropolis will together impact lives of lakhs of patient. All tests will be conducted at the Metropolis Global Reference Laboratory located in Kurla, Mumbai in the initial phase. Metropolis has been awarded thecontract on the basis of its vast experience and consistent quality performance. US FDA, IVD, CE and WHO approved kits will be provided by Roche. Keeping in line with its CSR commitment of positively bringing in a change in the community, this partnership comes in as a testament to Metropolis’ social responsibility.  Speaking on the alliance, Dr Naresh Goel, Deputy Director General, NACO said “8th February is a historic day because together we have begun viral load testing as a routine test for the first time. We are extremely happy that Metropolis will be our partner to deliver this project. The NACO model has won credibility across the globe for itsAIDS control program and for bringing down the prevalence. We have recorded a 67% dip in prevalence since 2000 and 54% dip in AIDS related death from HIV since 2007. The Viral Load Testing is an important step in our goal of Eliminating AIDS by 2030.” The NACO and Metropolis teams are geared up for the execution of the project. Kits used for testing will be US FDA Approved, IVD and CE approved to be provided by Roche. Dr Sushil Shah, Founder – Chairman, Metropolis Healthcare Ltd said “It’s a moment of pride for us because Metropolis was the first laboratory to start HIV testing back in 1985 and we have been doing HIV Viral Load Testing since 2005. We have a huge advantage in terms of quality and experience. We are confident that with thispartnership, we will be able to make a positive impact in people living with HIV.” Speaking on the partnership, Ms Ameera Shah, Promoter & Managing Director said “It is heartening to see the effort the government is taking to change the lives of people living with HIV. We are happy to be able to make an impact through our reports. Metropolis is fully equipped to support NACO in its vision in terms of expert team, quality of reports, best turnaround time and the infrastructure to do high volume testing.” ]]> https://biospectrumindia.com/news/22/10382/lonza-pharma-denali-therapeutics-to-develop-biologic-medicines.html https://biospectrumindia.com/news/22/10382/lonza-pharma-denali-therapeutics-to-develop-biologic-medicines.html Mon, 12 Feb 2018 15:40:00 +0530 Lonza Pharma & Biotech and Denali Therapeutics have announced an exclusive strategic partnership on Denali’s biologic pipeline products for neurodegenerative diseases. The agreement covers all stages of the development and manufacturing.  To treat neurodegenerative diseases biologics should be able to cross the tightly controlled blood-brain barrier (BBB). Denali is engineering its biologic product candidates. Through this partnership Denali will have access to Lonza’s extensive expertise and technologies from cell-line development using the GS Xceed Gene Expression System to process development and manufacturing at facilities in Slough (UK) and Hayward, CA (USA). In addition, Lonza’s in-house Drug Product Services in Basel (CH) will focus on ensuring that Denali’s finished product candidates are designed with optimal formulation, stability and delivery system in mind. Denali aims to discover and develop therapies to defeat degeneration, including diseases such as Alzheimer’s, Parkinson’s and ALS. Denali selects its targets based on validated genetic drivers of neurodegeneration, develops molecules that effectively cross the BBB and uses biomarkers to select the right patient population and demonstrate target and pathway engagement in clinical trials. ]]> https://biospectrumindia.com/news/22/10380/gileads-biktarvy-gets-fda-nod-to-treat-hiv-1-infection.html https://biospectrumindia.com/news/22/10380/gileads-biktarvy-gets-fda-nod-to-treat-hiv-1-infection.html Mon, 12 Feb 2018 12:55:00 +0530 Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Biktarvy a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy (FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the smallest INSTI-based triple-therapy STR available.  Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history. It is also specified to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. No dosage adjustment of Biktarvy is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.  Biktarvy does not require testing for HLA-B*5701, has no food intake requirements, and has no baseline viral load or CD4 count restrictions. Prior to treatment with Biktarvy, It’s suggested to test for renal function and hepatitis B virus (HBV) infection. ]]> https://biospectrumindia.com/news/22/10375/centre-gives-nod-to-rs142-cr-for-developing-igims-in-patna.html https://biospectrumindia.com/news/22/10375/centre-gives-nod-to-rs142-cr-for-developing-igims-in-patna.html Mon, 12 Feb 2018 10:40:00 +0530 The central government has approved Rs142.21 crore for Indira Gandhi Institute of Medical Sciences (IGIMS) in Patna under the Pradhan Mantri Swasthya Suraksha Yojana (PMSSY) for developing it as the state-of-the-art medical centre in Bihar. It is for the first time that the Centre has allotted funds to IGIMS under the ambitious scheme aimed at providing best medical facilities to the people at government hospitals at low cost across the country. Rs24.75 crore of the total allocated funds is for development of cardiac emergency facility and upgrading the present cardiac invasive and non-invasive care centre. Rs111.55 crore is for the project to develop and upgrade the regional institute of ophthalmology (RIO), while Rs5.91 crore is for upgrading the dialysis unit at IGIMS. IGIMS has also received Rs35 crore from central government and Rs8 crore from state government recently against Rs130 crore sanctioned for a cancer centre. The central government has asked IGIMS to send proposals along with cost estimates for purchasing and installing modern equipment in the field of medical science along with developing and upgrading existing medical facilities, especially in cardiology, nephrology and ophthalmology departments. ]]> https://biospectrumindia.com/news/22/10368/usfda-gives-nod-to-jubilants-generic-version-of-symmetrel.html https://biospectrumindia.com/news/22/10368/usfda-gives-nod-to-jubilants-generic-version-of-symmetrel.html Fri, 09 Feb 2018 13:30:00 +0530 Drug firm Jubilant Life Sciences announced that its subsidiary has received final approval from the US health regulator for Amantadine Hydrochloride tablets, an anti-viral and anti-Parkinsons drug. The approved drug, generic version of Symmetrel of Endo, is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus.  It is also indicated in the treatment of Parkinsonism and drug-induced extrapyramidal reactions. For Amantadine Hydrochloride tablets (100 mg), Jubilant Pharma Ltd, a material wholly owned subsidiary of the company, has received final approval of abbreviated new drug application (ANDA). This is the ninth approval received by the company from the USFDA during the current financial year. As per the company’s statistics, till December 31, 2017, Jubilant Life Sciences had 86 ANDAs for oral solids filed in the US, of which 56 have been approved and 12 injectable filings, of which 10 had been approved. ]]> https://biospectrumindia.com/news/22/10367/who-approves-first-freeze-free-vaccine-carrier.html https://biospectrumindia.com/news/22/10367/who-approves-first-freeze-free-vaccine-carrier.html Fri, 09 Feb 2018 11:40:00 +0530 Indian-made vaccine carrier using PATH's Freeze-Safe reference design has passed WHO Performance, Quality, and Safety (PQS) laboratory tests for User Independent Freeze Prevention, which prequalifies it for use in global immunization programs. The first commercially available freeze-free vaccine carrier will begin introductory field trials in Nepal very soon. This is the first low-cost carrier innovation available to address the widespread and long-standing problem of vaccines freezing in the cold chain during the last mile of outreach to infants and children. PATH's breakthrough solution mitigates the risk of vaccines being damaged by freezing or heat in carriers and eliminates the step of conditioning ice packs, reducing health worker burden. Frozen ice packs can be inserted immediately into the carrier thanks to a built-in barrier that shields the vaccines from reaching negative temperatures and excessive heat. In order to rapidly accelerate introduction of this innovation, PATH put the Freeze-Safe reference design into the public domain for any manufacturer to use in their vaccine carrier products. PATH staff in Seattle and New Delhi, India, have provided technical advice to three product manufacturers who have adopted the technology. India-based AOV International's product AFVC46 is the first carrier to receive WHO-PQS approval and will be available for purchase through the UNICEF Supply Division catalog.   ]]> https://biospectrumindia.com/news/22/10365/dr-reddys-recalls-over-80k-atorvastatin-bottles-from-us.html https://biospectrumindia.com/news/22/10365/dr-reddys-recalls-over-80k-atorvastatin-bottles-from-us.html Fri, 09 Feb 2018 11:05:00 +0530 Dr Reddy's Laboratories has initiated the voluntary recalling of more than 80,000 bottles of its drug Atorvastatin Calcium Tablets 10mg, 20mg and 40mg from the US market due to quality concerns. According to a notification issued by the US Food and Drug Administration (USFDA), multiple lots of Atorvastatin 10 mg, 90 count and 500 count bottles; 20 mg, 90 count and 500 count bottles and 40 mg, 90 count bottles, are being withdrawn from the market. Atorvastatin is a drug that blocks the production of cholesterol and reduces its level in the blood. The product is being recalled through three separate letters to the drug regulator. The product was manufactured at Dr Reddy's Srikakulam plant in Andhra Pradesh. Once the FDA completes the hazard assessment, the Enforcement Report entry will be updated with the recall classification (Class I, II or III) indicating the hazard posed by the recalled product(s). ]]> https://biospectrumindia.com/news/22/10359/novartis-gets-fda-approval-for-cosentyx-label-update.html https://biospectrumindia.com/news/22/10359/novartis-gets-fda-approval-for-cosentyx-label-update.html Thu, 08 Feb 2018 15:10:00 +0530 Novartis announced that the US Food and Drug Administration (FDA) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) antagonist approved to treat moderate to severe plaque psoriasis. The updated label includes Cosentyx data in moderate to severe scalp psoriasis; one of the difficult-to-treat forms of the disease, which affects approximately half of all psoriasis patients. The label update is effective in the US immediately, and is based on the proven efficacy and consistent safety profile of Cosentyx from a dedicated Phase III scalp psoriasis trial. The updated label for Cosentyx in scalp psoriasis addresses an important unmet need. Scalp psoriasis can be challenging to treat with topical agents or phototherapy due to the presence of hair and other factors.  Cosentyx is currently the only fully human IL-17A antagonist to demonstrate efficacy and safety in a dedicated Phase IIIb study of scalp psoriasis. The label update is based on 12-week primary endpoint results from the US study of moderate to severe scalp psoriasis patients where Cosentyx (300 mg) demonstrated superior efficacy compared to placebo.  Cosentyx, in a separate study, has demonstrated sustained long-term efficacy, as well as a safety profile consistent with that seen in pivotal trials. ]]> https://biospectrumindia.com/news/22/10348/mesa-biotech-gets-fda-510k-approval-and-clia-waiver-for-influenza-test.html https://biospectrumindia.com/news/22/10348/mesa-biotech-gets-fda-510k-approval-and-clia-waiver-for-influenza-test.html Wed, 07 Feb 2018 16:25:00 +0530 Mesa Biotech is a privately held, molecular diagnostic company that has developed an affordable PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis. The company announced that it has received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for its Accula™ Flu A/Flu B test. The company's Flu A/Flu B test cassette will be its first available test in the U.S. market.  CLIA establishes quality standards for laboratory testing to ensure the accuracy and reliability of patient test results. CLIA waived tests must meet stringent quality requirements to be used in non-laboratory POC settings. The CLIA-waived Accula Flu A/Flu B test brings PCR testing to the POC providing a qualitative result in approximately 30 minutes to guide same day treatment decisions. The Accula Testing System offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing. The Accula Flu A/Flu B test is indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs and allows for a more comfortable specimen collection experience for the patient. ]]> https://biospectrumindia.com/news/22/10326/nims-to-establish-advanced-medical-treatment-centre.html https://biospectrumindia.com/news/22/10326/nims-to-establish-advanced-medical-treatment-centre.html Tue, 06 Feb 2018 10:45:00 +0530 Hyderabad based Nizam Institute of Medical Sciences (NIMS) is planning to incorporate a central laboratory system and to launch a new Stem Cell Department to provide most advanced medical treatment to the people of Telangana state. At present the proposed stem cell research centre and bone marrow transplantation facilities are under construction and once these two facilities will come into operation, the poorest of the poor can avail most advanced treatment facilities at affordable rates. NIMS is regarded as one of the best hospitals run by the government in the state. It is the only hospital in the government sector to have advanced medical treatment facilities on par with some of the leading Super Speciality Hospitals in Hyderabad. Dr. C. Laxma Reddy, Minister for health and medical education, stated that the government is giving highest priority to provide most advanced and quality healthcare to the people. As part of this for the first time in the state, stem cell research centre and a central laboratory system is being introduced. With these new advancements, the government is planning to expand more and more new medical services to the public. ]]> https://biospectrumindia.com/news/22/10320/fda-approves-ferrings-zomacton-to-treat-growth-hormone-deficiency-in-adults.html https://biospectrumindia.com/news/22/10320/fda-approves-ferrings-zomacton-to-treat-growth-hormone-deficiency-in-adults.html Mon, 05 Feb 2018 11:15:00 +0530 Ferring Pharmaceuticals is a research-driven biopharmaceutical company, announced the U.S. Food and Drug Administration (FDA) has approved ZOMACTON (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH deficiency. Adult growth hormone deficiency (GHD) occurs in approximately 1-2 adults per 100,000 and can be a continuation of childhood onset growth hormone deficiency or have an onset in adulthood resulting primarily from trauma, surgery or radiation to the head. GHD in adults is characterized by metabolic dysfunction, reduced physical strength and activity, altered lipid metabolism and increases in body fat.  ZOMACTON is also indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone. ]]> https://biospectrumindia.com/news/22/10319/indo-uk-institute-of-health-to-set-up-medicity-in-assam.html https://biospectrumindia.com/news/22/10319/indo-uk-institute-of-health-to-set-up-medicity-in-assam.html Mon, 05 Feb 2018 11:05:00 +0530 One of the largest public-private partnership (PPP) healthcare infrastructure projects in the world, Indo UK Institute of Health (IUIH) plans to sign a Memorandum of Understanding (MoU) with the Government of Assam for setting up an integrated IUIH Medicity in the state. The Indo UK Institute of Health (IUIH) Medicity Programme was announced as a Joint Statement between the Prime Minister of India Narendra Modi and the former Prime Minister of the United Kingdom David Cameron in 2015.The programme involves an investment of Rs 17600 crores into Indian healthcare aimed at benefitting over 400 million Indians by opening 11 institutes across India in partnership with the world's best healthcare system - the National Health Service (NHS), UK. Each IUIH Medicity, including the one to come up in Assam, shall be developed with an investment outlay of Rs 1600 crores and have a 1000 bed hospital in association with one of UK's leading NHS hospital. The IUIH Medicity in Assam shall also have medical college, nursing college, PG academy and a training facility for allied health professionals. IUIH has tied up with leading implant companies like Stryker, Medtronics, Zimmer Biomet, Johnson & Johnson; and leading medical equipment companies like Toshiba, GE healthcare, Philips, Canon etc. Many of them would start their manufacturing operations in IUIH Medicities in accordance with Prime Minister Modi's 'Make in India' program bringing the healthcare cost further down for patients in India. Besides Assam, the other 11 states to benefit from the IUIH programme include Maharashtra, Andhra Pradesh, Telangana, Punjab, Gujarat, Rajasthan, Karnataka, Uttar Pradesh, West Bengal, Madhya Pradesh and Haryana. ]]> https://biospectrumindia.com/news/22/10307/healthcare-budget-2018-focuses-on-universal-health-coverage-making-healthcare-more-accessible-.html https://biospectrumindia.com/news/22/10307/healthcare-budget-2018-focuses-on-universal-health-coverage-making-healthcare-more-accessible-.html Fri, 02 Feb 2018 12:00:00 +0530 Finance Minister announced two major initiatives under the Ayushman Bharat Program in the Union Budget 2018 catering to primary, secondary and tertiary care. One, with the National Health Policy announced last year, the Government proposed establishment of 1.5 lakh health and wellness centres with an aim to provide comprehensive care to the people for treatment and diagnostics for NCDs as well as Maternal and Child Health. Government committed Rs1200 crore for this flagship programme. Government also invited contribution from the private sector as a part of their CSR mandate for adoption of these Wellness and Health Centres. And two, the National Health Protection Scheme - with an aim of reaching to about 10 crore poor and vulnerable families, the government plans to reach out to approximately 50 crore beneficiaries, providing up to Rs 5 lakh health insurance cover per family per year. This will include Secondary and Tertiary Care. Mr. Shireesh Sahai, CEO, Wolters Kluwer India said, “The announcement of the Ayushman Bharat Programme is a bold and ambitious move in the right direction. Once rolled out, it will hasten India’s progress towards achieving universal health coverage for all. Fresh investment in healthcare delivery infrastructure and medical education are also welcome developments, given that healthcare education and delivery need to be efficient for insurance outlays to be used optimally. The increase in medical colleges will hopefully change our presently skewed doctor-patient ratio. Mr. Ganesh Sabat, CEO,  SMT (Sahajanand Medical Technologies Pvt. Ltd) for your reference said, "This year’s Union Budget has been a people’s budget with a focus to uphold Modi’s ‘Make in India’ campaign. Schemes such as the launch of National Health Protection Scheme and bringing 24 new medical colleges pan India are some useful highlights being implemented by the Government. Through the introduction of these massive health programs, the Government is giving a clear signal that it is concerned about the healthcare and social security of the masses and they believe that medical healthcare is one of the backbone of the economy. This step is a productive move towards the path of universal healthcare for the poor and weaker section of our society.” India must now consider the use of adaptive learning and mobile-based learning technologies in medical education, which will help our medical practitioners make the most of the latest developments in medicine and use global best practices to improve healthcare delivery in India. Countries that score high on healthcare metrics have made significant investment in healthcare technology that enable healthcare practitioners to make evidence based clinical decisions, which in turn lowers mortality and healthcare costs. Insurance companies that would be the implementation channels for the National Health Protection Scheme will benefit from the technologies that enable clinical effectiveness because they minimize risk and improve efficiencies. We look forward to partnering with the government in implementing these transformative programmes in India.” Government further announced doubling of funding to Rs3073 crore for digital technology, artificial intelligence, block chain technology, big data, robotics that would encourage and further spur a growth of the startup ecosystem in the country. Commenting on the healthcare budget and the allocation of Rs 1200 crore towards Health and Wellness Centres that will provide comprehensive health care, including for non-communicable diseases, Abhishek Shah, Co-Founder of Wellthy Therapeutics said, “This step will significantly help in combatting one of the biggest challenges in healthcare in India today, which is the rising burden of Non-communicable diseases (NCDs). NCDs such as diabetes, cancer, and heart disease contribute to 61% of all mortalities every year in our country, and the WHO estimates that these will cost India almost $5 trillion dollars by 2030. This budgetary allocation for the prevention and treatment non-communicable diseases will be a critical step to stem the tide now. Furthermore, the launch of the National Health Protection Scheme is another vital move for achieving universal healthcare in India. In the last decade, we have watched our neighbor, China, successfully expand its UHC from a negligible number to 900 million citizens (95% coverage). A 5 lakh benefit / family for both primary and secondary healthcare, as long as its covering the wide range of healthcare issues and costs that it promises to be, is a huge boost by the government to provide the necessary impetus for India to achieve that rate of coverage. Proactive steps like this by a forward-thinking government can help enablers in healthcare to win the war against the disease burden in our country.” Overall, Union Budget 2018-19 has proven to be a comprehensive, wide ranging and balanced budget, with many positives for the health sector. While the health budget has increased by 12 percent this year over last year, that still amounts to only 1.15% of GDP. India has the second largest population in the world and carries one-fifth of the disease burden. For us to further strengthen our health systems and provide affordable and accessible care to all, the healthcare budget needs a larger portion of the pie. This budget is indicative that we are headed in the right direction but need to accelerate our efforts. ]]> https://biospectrumindia.com/news/22/10302/healthcare-sector-responds-to-union-budget-2018.html https://biospectrumindia.com/news/22/10302/healthcare-sector-responds-to-union-budget-2018.html Thu, 01 Feb 2018 16:45:00 +0530 “The Union Budget 2018 has taken a huge step in making healthcare affordable and accessible by launching the world’s largest healthcare scheme. It is indeed heartening that 40 per cent of India’s population will be covered under an insurance scheme. The payor problem demanded urgent attention and the government has paid heed. If the Flagship National Health Protection Scheme to cover 10 Cr poor and vulnerable families with upto 5 Lakhs per family per year for secondary and tertiary care hospitalisation is properly implemented and monitored we would have taken an important step in creating a Swasth Bharat. Effectively this initiative which amounts to $800 billion dollars tops even the US’ Medicaid programme which amounts to $550 billion.” Suneeta Reddy, MD, Apollo Hospitals   “My heartiest congratulations to this government for investing in creating a Swasth Bharat by launching the Ayushman Bharat programme. Such ambitious out of the box thinking was a burning need of the hour and the government has not disappointed. The initiative to cover 10 crore families with 5 lakh per family/per year WITH INSURANCE COVER FOR SECONDARY AND TERTIARY HEALTHCARE will be a game changer.” Dr. Prathap Reddy, Chairman, Apollo Hospitals    “The government’s focus on rural development and agriculture is a welcome step. The long overdue emphasis on our rural economy and agriculture will stimulate demand. The announcement of the Aayushman Bharat program for healthcare is a game changer and the coverage of ten crore people under the National health protection scheme is commendable. This will give an impetus to healthcare benefits for people in the most deserving sections of society. Overall, while the budget appears to be a progressive one, it was disappointing to note that the reduction in corporate tax was offered only to companies with a turnover under of Rs. 250 crores.” Satish Reddy, Chairman, Dr. Reddy’s Laboratories     “We applaud the announcements made by the Government in the Union Budget 2018 which has indeed addressed a lot of issues that will help the economy to prosper. It aims in creating the largest healthcare blanket for the biggest democracy of the world. The Government's initiative of setting up 1.5 lakh health facilities across the country will help bring healthcare closer to homes of the people, and will enable them to receive medical help within the golden hour hence improving the chances of survival. Granting 50 crore beneficiaries and 10 crore families, 5 lakh rupees per year cover secondary and tertiary hospital expenses is a breakthrough move and the world's largest government-funded healthcare program . This will allow the poor to access world class healthcare facilities which was not affordable or available earlier.  Also, the announcement of setting up one medical college for every three parliamentary constituencies is great as this will help in training the emergency medical technicians which will, in turn revolutionize the quality of care of the emergency medical response services in the country." Mr. Naresh Jain, CEO, Ziqitza Healthcare Ltd   "The government has reiterated its commitment to ‘Universal Healthcare’ and has announced flagship schemes to provide better healthcare to people at bottom of the pyramid – National Health Policy and Rashtriya Swasthya Bima Yojana. These schemes will expand the reach of basic healthcare facilities in the country. While access to basic healthcare is an important determinant of Universal Healthcare, another critical factor is quality of healthcare. The latter requires access to advance healthcare technology for best health management of patients. The government should have looked at incentivising import of advance medical devices into the country by bringing down the customs duty. There is also a need to undo the un-nuanced price control imposed by NPPA as the move is leading to unintended consequences on the healthcare ecosystem without any significant reduction in the cost of patient. The current price control regime has also lead to a drastic fall in foreign direct investment in healthcare sector from $417 million in April-September 2017 against $173 million in the same period in 2016, a reduction of 59 per cent. Under the current ecosystem where more than 70 per cent of medical devices have to be imported from abroad, a balance approach to reduce cost to patient is trade margin rationalization for distributors, gradation in pricing thereby allowing a higher price bracket for superior medical devices, and lower customs duty. These measures will reduce the cost to patient without dis-incentivizing technical innovation by medical device manufacturers." Mr. Pavan Choudary, Chairman & DG, Medical Technology Association of India (MTaI)   “It is really encouraging to see that the government has laid strong emphasis on Healthcare by announcing the World's Largest Health Protection Plan. We are confident that progressively, similar importance will be given to Home Healthcare which is fast becoming an important element in the health Management value chain" Mr. Rajiv Mathur, Founder, Critical care Unified (CCU)   “Budget 2018 has definitely added significant impetus to the healthcare sector with emphasis on the elderly and underprivileged. The biggest declaration by the Hon'ble Finance Minister was the health protection scheme where 10 Cr poor families - for secondary and tertiary treatment - will get 5 lakhs per family. This announcement could be the first steps towards Universal Healthcare in India. The Finance Minister announced that 24 new government medical colleges will be set-up and this could be a big incentive for medical education in the country. The allocation of Rs. 1200 Cr towards health & wellness centres and Rs 600 Cr towards nutrition for patients suffering from Tuberculosis are positive steps. We were pleased to hear in the Budget that the Government has allowed Senior Citizens to claims benefits of Rs 50,000 as part of medical insurance - earlier this was Rs 30,000. However, the government’s discontinuing of Rs 15,000 per annum for medical benefits to salaried employees - as per today’s Budget announcement, is unfortunate. We welcome an increase in the cess from 3% to 4% as tax revenues - slated to be around 11,000 Cr, is welcomed and we are looking forward to seeing how the government intends to utilize and distribute the revenues collected from this cess increase.”  Mr Mustafa Daginawalla, CFO, Saifee Hospital   "Overall, this has been a pro-people and a pro-poor budget. For the first time, Universal Health Care has got the impetus it needs. I am quite happy with the government's plan to introduce 24 new medical colleges. That is the only way to address the glaring lack of talent in the industry. The 1.5 lakh centres which will provide free essential drugs and diagnosis is a welcome move and a step towards boosting the Government’s National Health Policy. The flagship national healthcare protection scheme which will cover 10 crore, underprivileged families, is a highly commendable initiative. Through the budget, the government has definitely shown its interest in making healthcare more accessible and affordable through the Ayushman Bharat programme. Another highlight of the budget has been the focus on fighting the ever-growing hazards of pollution from crop burning, promotion of gas connection in houses using wood fire for cooking, among others. By not just talking about healthcare, but its indicators as well, the government is definitely on the right track towards improving the sector across the country. We truly hope that going forward, the government also has plans for utilisation management, financial monitoring, audit mechanisms and accountability". Ms. Ameera Shah, Promoter and Managing Director, Metropolis Healthcare Ltd.   “The life sciences (LS) sector today is at crossroads; on one hand there is increasing lifestyle diseases and a fast-improving awareness about health, and on the other hand we have a sector facing intense competition, pricing and regulatory pressure both in the domestic and international market. Life sciences had great expectations from the Budget not only from the fiscal incentives perspective, but also from a regulatory angle, given how crucial the sector is not only from a healthcare standpoint but from an economic and social development perspective.  Further, the sector was bullish given the government’s vision of making India one of the top-three pharmaceutical markets by 2020. The proposed National Health Protection Scheme (NHPS), the world’s largest government-funded, universal healthcare programme is a tremendous revolution which will drive greater investment in hospital infrastructure in tier-2 and tier-3 cities and also lead to evolution of existing business models to address health needs of people covered under this scheme.  Higher healthcare consumption will be positive for life sciences industry and is likely to boost demand; this may however require companies to invest in increasing the depth of their distribution networks.   The abolition of Education cess of 3% along with introduction of Social Welfare Surcharge @10% on custom duties would have a negative impact on this industry.  The private sector has been asked to partner the Government by adopting centres under the Rashtriya Swastha Bima Yojna and also contribute in the NHPS by offering free essential drugs and services. While the move to provide nutritional support to tuberculosis patients; 24 new medical colleges are welcome, the Budget has not specifically addressed imminent challenges directly affecting the life sciences sector.  In order to stay competitive in the overseas market and given the uncertain global climate, it was expected that specific impetus or incentives would be given to research and development to promote innovation in the form of weighted deduction; capital linked subsidy schemes to upgrade MSME units; incentives for bulk drugs, patents, clinical trials etc. These demands remained largely unaddressed, giving no specific reason to cheer for the sector as a whole in 2018–19.”  Santosh Dalvi, Partner and Head-Indirect Tax - West India, KPMG in India   ‘’The budget addressed a few aspects at a very high level, the creation special hybrid vehicles which would optimize taxation for foreign investors is very welcome news. All other aspects was addressed at a very high level, including the mention of a new regulatory body under SEBI. Unless there is more clarity provided very soon, the situation will not be optimal for both start-ups and investors. For example, GST norms have to be relaxed, in terms of reduced rates for start-ups, as well as the ability to file on an annual basis, there was no mention of this. There was no mention of not implementing angel taxes, no mention of giving the angel investors vehicles towards reduced taxes or no taxes if they could roll over gains to other start-ups. Most countries allow this as it keeps a perpetual line of early stage funding open to start-ups. It also appears as if more regulatory bodies are being set up like the body under SEBI, hopefully this does introduce more processes which may not bode well for start-ups, and funds. It is good to note that there is a focus on technology, especially AI/ML, details unfortunately were also missing, Would there be special government funds focusing on AI/ML which VC funds could leverage, would there be a focus around skills development for the next generation to take advantage off. Once again, clarity would be most welcome, and that too in a timely manner. In conclusion, the next level of details need to be articulated soon with a focus on helping start-ups attract investments, optimize their cash flow and scale. This is very critical for the future if we want start-ups to be the back bone of our new economy.’’ Dr. Srikanth Sundararajan, Partner, Ventureast   "The Union Budget 2018 has taken a step towards making health care more accessible with it's flagship National Health Protection Scheme initiative which provides upto Rs 5 lakh per family per year, for hospitalization. However, the devil is in the detail as the million dollar question that prevails is - will these benefits be cascaded to the common man? On the business front, unfortunately, there has been no special mention of health-tech startups in general. Private healthcare sector should have been provided subsidy and exemption from GST to facilitate the greater spread of business and enable government's push to make healthcare accessible to all. Furthermore, on one hand, the government is talking about going digital, however, it has not supplemented the act by connecting it the digital drive with certain sectors such as healthcare and education which serve to be the backbone for the upliftment of well being of the society as a whole." Ravi Virmani, CEO & Founder, Credihealth   Healthcare Industry: "Fueled by the 1200 Cr allocation for healthcare, what is exciting is the 1.5 lakh new healthcare centers that are going to be initiated. For a country that presents the highest number of patients in area of Breast Cancer and Head and Neck (Oral) Cancer cases in the world, these centers needs to be equipped with primary Onco scanning and treatment options. An early detection and treatment option would reduce healthcare cost burden on the Indian exchequer by several thousand crores in terms of disability adjusted life years (DALY)". Biotechnology Industry: "Biotech industry expectations for dedicated research funds in the area of Biosimilars development and Regulatory Ecosystem remains unattended. India definitely requires financial focus to ramp up this area and craft out its position in the world healthcare scene". Debayan Ghosh, Founder & President of Epygen Biotech Pvt Ltd   “A mere 11.5 per cent increase in budgetary allocations for health from Rs. 47,353 crore from previous year to Rs. 52,800 crores is disappointing and discouraging especially with the announcement of schemes that require large sums of money. The budgetary allocations are clearly mismatched with the stated policies goals despite the political commitment to increase investments in health (National Health Policy 2017), family planning, and achieve better health outcomes (SDG Goals).  The continuing trend in lower budgetary allocations for health reinforce the fact that, while there is the intention and attempt to improve the health status in the country, the financial commitment continues to be missing for translating these goals into action. The allocation for family welfare schemes under central sector schemes/projects, which is meant for procurement and distribution of contraceptives have increased only marginally by 2 per cent (Rs. 770 crore) over the budget (Rs. 755 crore) last year. This will be insufficient not only to meet the future demand but will also fall short of the current demand for contraceptives and for improving the much needed quality of services. The Ayushman Bharat initiative and the National Health Protection Scheme announced by the Finance Minister is a welcome move for the country’s healthcare development as they intend to significantly reduce the cost of healthcare borne by the households on medicines, diagnostics and hospitalisation. While both these schemes are conceptualised with good intentions, the government has to match up with a strong regulatory framework and clear financial outlays and implementation plans.           While universal access to health care services remains a distant dream with the current allocation strategies of the government, resource prioritisation is the key to effectively utilise the available budgets for primary health care. To quote an example, prioritising critical elements of reproductive health care for instance can reduce large expenses incurred on incentives and compensation. Rather, these amounts can be used more productively to improve the quality of care and strengthen health service delivery”. Poonam Muttreja, Executive Director, Population Foundation of India   “Healthcare sector has been a clear priority in budget 2018. There has been a good balance on short term respite from out of pocket health costs & building capacity in the long term. The Ayushman Bharath the scheme to provide health cover to 50 crore Indians of Rs 5 lakhs is simply audacious in scale and reach and could be a game changer. Healthcare needs to be universally accessible and also start from preventive care. This should be taken care of with the proposed 1.5 lakh health & wellness centres. The idea to increase the number of doctors is good with the 24 district hospitals being upgraded, however strengthening of the other post graduate programmes like the DNB course would also need to be done simultaneously. Health can be one of the key job creators. More focus from the Skill India initiative with these announcements should see this sector contribute in this area too. We hope that other announcements like the Pradhan Mantri Research Fellowship & the Research allocation would also spur healthcare research. With 1200 crores to the National Health Policy , we look forward to a continued impetus to the National Programme for Control of Blindness which is one of the most successful Public – Private healthcare programmes. It would be interesting to see how these would be funded, the finance minister indicated a widening of the tax base and an additional 1% cess, we only hope that the 3.5% fiscal deficit does not force a rethink on these allocations later. Also it would be good to expand the ease of doing business to ease of working with insurance & schemes and simplifying the process for health care providers.” Dr. Kaushik Murali, Paediatric Ophthalmologist & President, Sankara Eye Hospital   “The proposed union budget for 2018 seems promising. I’m elated to learn about the ample attention that has been given to the healthcare sector.  Healthcare, agriculture, and education are fundamental tenets of the country, concentrating on the development of these three sectors is the need of the hour; and the budget would definitely augment the growth and development of the said sectors. The allocation for the health insurance sector seems propitious. Statistics reveal that an alarming 7% of the population is pushed below the poverty line due to the direct consequence of an unseen medical emergency;  Even with these alarming numbers, a mere  20% of the population is covered, either, by public or private insurance. Healthcare is one of the key factors responsible for throwing people into abject poverty and putting them in dire financial conditions.  It is critical and the country needs to act up on working towards the betterment of this particular arena. The National Health protection scheme, covering 10 crore families and providing Rs 5 lakh cover per family per year for the medical treatment, is a commendable effort to tackle this mammoth issue. All of us, in the healthcare startup circle, were vying for the government’s attention towards digital healthcare as it is the only way to make world-class healthcare accessible to the masses. The rationale behind this is, 72% of the primary health care issues can be solved online without physical presence of the patient; whereas secondary and tertiary healthcare require the patient to visit the facility. Even post-op activities, like follow-ups, can be undertaken online ruling out the need to travel far and wide to for a routine visit. DocsApp serves over 2000 people every day, 40% of these people hail from villages and towns falling below tier 3 cities; this highlights the need for enhancement and development of digital solutions. Digital healthcare solutions help to minimize infrastructure costs, they’re the most effective way to ensure delivery of world-class healthcare in the underserved parts of the country. The boost given to telecom infrastructure and the move to establish wi-fi centers is a clear indicator of the shift from offline to online facilities. Every service, from healthcare to education, will be easily accessible to the people of the country. DocsApp is keen to work with government to make universal health care available to the masses in the near future.” Satish Kannan, CEO & Co-founder DocsApp   “Today’s budget has definitely boosted the spirits of the healthcare sector. The announcement around the National Health Protection Scheme, which will provide Rs. 5 lakhs medical reimbursement for the poor will be beneficial to nearly 50 crore people. The lack of clarity in processes was also witnessed with the Ayushman Bharat program as the tertiary healthcare sector was not touched upon.  The government also took a massive stride in making medical education more accessible, by setting up 24 government colleges and hospitals. The effort would see more traction by joining hands with the private sector to implement colleges that can provide aspiring doctors with quality learning. We hope that in the coming months, this ambiguity is resolved to make quality healthcare available to the masses, in a clear and structured way”. BS Ajaikumar, Chairman & CEO, HealthCare Global Enterprises Ltd   "The Budget is very much in line with the expectations of FICCI. It will drive consumption in a big way, thus helping growth in other related sectors. Additionally, the attention to the MSMEs through better access to finance or lowering of the corporate tax rate would also help spur both employment and growth in this vital segment of the economy. FICCI also believes that the stress on jobs in the Budget will help generate meaningful employment going ahead. Another path-breaking announcement in the budget relates to the new National Health Protection Scheme under which an annual health insurance cover of Rs 5 lakh will be provided to nearly one third of the households. This is the world's largest government funded healthcare programme and would lead to a clear increase in demand for quality healthcare facilities and services and to match this rise in demand, several measures have also been announced to improve supply of quality health services in the country. However, given the performance on the disinvestment front this year, there were hopes that the government would be more ambitious in terms of setting the target for the next year - the Rs 80,000 crore target for disinvestment receipts in FY19 is a bit conservative in FICCI's view. The continuation of STT even while re-introducing LTCG will put some additional burden on the market participants. This, however, should not impact markets in the long-term. With the markets giving a compounded return of 15-16% over the last 20 years, a tax impacting 1.5% return should not affect the domestic investor appetite for equity investment. Finally, while consolidation process for the public-sector insurance companies has been indicated, FICCI hopes that a similar plan for the banking sector as was widely anticipated ahead of the budget will also be announced soon." Mr. Rashesh Shah, President, Federation of Indian Chambers of Commerce and Industry (FICCI)   “Healthcare is a big winner in this budget with an emphasis on reaching the unreached. It is encouraging to see that the Government has announced the largest government-funded healthcare program insurance scheme of up to Rs 5 Lakh per year for secondary and tertiary care hospitalization. This scheme will also create new jobs in the healthcare sector and will result in opening of healthcare centers in small districts, towns and villages. This scheme will further empower the poor and under privileged to avail medical services.” Dr Somesh Mittal CEO, Vikram Hospital   “The budget rightly provides a focus on Agriculture, Healthcare & Education. The big move towards the path of Universal Healthcare Coverage under the flagship National Health Protection scheme which will bring 50cr citizens with Rs 5 lac/family for secondary and tertiary care hospitalisation is transformational for the country. The question to answer is how will the scheme be funded and executed given the fact that health is also a state subject. This move coupled with the announcement of 24 additional govt medical colleges and hospitals gives healthcare the centre stage in this budget. In addition the increase in tax exemption for senior citizens on health insurance premium and medical expenditure is a good move. This was also the opportune time for the FM to give infrastructure status to the healthcare sector and provide the much needed acceleration to capacity creation in the sector. The reduction in corporate tax for SME businesses with revenues up to Rs 250cr is a step in the right direction to push the agenda of their growth and the Rs 10k cr outlay for the telecom infrastructure under Govt projects including the support for establishment of indigenous 5G centres with IIT Chennai is an excellent move. Overall a budget that’s high on promise and execution will hold the key.” Vishal Bali, Co-Founder & Chairman, Medwell Ventures   “There are two announcements which will impact the healthcare delivery industry. The  Suraksha Bima Yojana enhanced limit of 5 lakh rupees per family is yet to be launched, so the details and capital allocation will only be known when it is launched. However, the intent is quite positive, as almost 40% of underprivileged population would be able to access the secondary and tertiary care healthcare, and this would increase the market size for healthcare providers radically. The second scheme is for 1.5 lakh healthcare centres, where the budgetary provisions are only 1200 crores. However, it may be a good beginning for creating healthcare accessibility to the rural poor. The investment in hospitals is a subject matter of viability, so it is yet a bit premature to assess the investment potential of the schemes announced. However, if the prepositions are commercially viable, these would be opening a vast market for the investments to flow in.”    Ms. Zahabiya Khorakiwala, MD, Wockhardt Hospitals group   ]]> https://biospectrumindia.com/news/22/10299/budget-2018-rs-1200-crores-earmarked-for-flagship-healthcare-program.html https://biospectrumindia.com/news/22/10299/budget-2018-rs-1200-crores-earmarked-for-flagship-healthcare-program.html Thu, 01 Feb 2018 12:25:00 +0530 "We are allocating Rs 1 Lakh crore in the next four years to boost Research and Development. We are also coming up with a specialised railway university at Vadodara. Demographic dividend realisation is impossible without proper healthcare. Health and wellness centres to bring healthcare closer and more accessible to people. Rs 1200 crores earmarked for this flagship program under the National Health Policy 2017. Healthcare protection is at a new aspirational level. We are now launching a new national health protection scheme – Rashtriya Samaj Beema Yojana. This will have 50 crore beneficiaries and 10 crore families will get 5 lakh per year for their families to cover secondary and tertiary hospital expenses. This is the world's largest government-funded healthcare program. A Rs 600 crore corpus is being set up to help Tuberculosis patients. This will build a new India in 2022 and enhance productivity and will also generate lakhs of jobs for women. We are progressing towards Universal Health Coverage," says Finance Minister Arun Jaitley. National Health Protection Scheme, the world’s largest government-funded universal healthcare programme, announced. Health and wellness centres to bring healthcare closer and more accessible to people. National Health Policy to have Rs 1,200 crore allocation. Rs 600 crore corpus set up to help TB patients. One government medical college to be ensured for every three parliamentary constituencies by upgrading 24 district-level colleges. ]]> https://biospectrumindia.com/news/22/10294/suven-acquires-2-product-patents-each-from-african-organization-and-south-korea.html https://biospectrumindia.com/news/22/10294/suven-acquires-2-product-patents-each-from-african-organization-and-south-korea.html Wed, 31 Jan 2018 17:35:00 +0530 Suven Life Science is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products, which are first in class or best in class CNS therapies using GPCR targets. The company has secured a product patent each from the African Regional Intellectual Property Organisation (Aripo) and South Korea corresponding to new chemical entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases. The two patents are valid through 2033 and 2034, respectively. The granted claims of the patents include the class of selective 5-HT4 and 5-HT6 compounds respectively and are being developed as therapeutic agents for major depressive disorders and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Narcolepsy, Parkinson. The Company has 9 internally-discovered therapeutic drug candidates, currently in various stages of pre-clinical development targeting ADHD, dementia, depression, Huntington’s disease, Parkinson’s disease and pain. ]]> https://biospectrumindia.com/news/22/10293/industrys-expectations-from-budget-2018.html https://biospectrumindia.com/news/22/10293/industrys-expectations-from-budget-2018.html Wed, 31 Jan 2018 16:00:00 +0530 Ahead of the Budget 2018, BioSpectrum takes quotes from the people in the industry on how it should be. Here are the suggestions: Mr. Surajit Chakrabartty, CFO, MedGenome.  Government should take steps to bring together academia and industry  “Biotech is an emerging sector which needs government push to tackle the burden of communicable and non-communicable diseases. The government should aim at creating a conducive atmosphere of fostering research, development and innovation, if it really wants its dream of Make in India drugs/biomarkers/biosimilars, a reality. We expect the budget to make provisions for increased public health spending, investing in building and maintaining public health infrastructure, setting up new medical academies and consider making health insurance mandatory for all. Ensure public health spending is utilized in an efficient manner by involving representatives from corporate sector, research institutes and bureaucrats to oversee the progress and guide accordingly. Priority status to healthcare sector including hospitals & diagnostic centers and incentivizing technology-driven companies would boost expansion of healthcare services across the country. Apart from budgetary allocations, the government should also take steps to create an ecosystem that brings together academia and industry to boost innovation in healthcare.”  Dr Anitha Arockiasamy, President, India Home Health Care. Government should focus on addressing non-communicable diseases We feel that the budget should focus on allocation of resources and adequate funds for skill upgradation of not only doctors but also nurses too. There is also a need to introduce new innovations in the home healthcare segment, and encourage the availability of care at home, thus freeing up hospital beds and helping patients recover at their homes at a lower cost. We feel that the government needs to have initiatives in place to spread awareness about healthcare, especially geriatric care, in semi-urban and rural areas as this is developing to be a highly needed service with the changing demographics and disease patterns. There are growing concerns about increase in non-communicable diseases such as cancer, heart related ailments, diabetes among others and we expect that government will focus on addressing these diseases. Ms Ameera Shah, MD & Promoter, Metropolis Healthcare Budget should address the National Health Protection Scheme  "This year has been an important one for healthcare. Various initiatives ruled under the National Health Policy have helped in larger strata of the Indian population to access medical services at affordable prices. Post introduction of GST, the tax rate on medical devices was pegged at 12%, this, if reduced further can positively affect the overall cost structure thereby providing cost effective healthcare services to the society. The last budget had a lot of focus on policy direction and targets for elimination of chronic diseases which is laudable. In addition to increased spending, we also hope that this year’s budget will address the National Health Protection Scheme and set impetus to generate demand for health insurance through additional exemptions.” Mr. Manish Sacheti, CFO, Ziqitza Healthcare Ltd Amendments should be made for better public healthcare services    "We hope that the Union Budget 2018-19 offers a major relief to the healthcare scenario in our country. While the Government has introduced various amendments in the budget last year there are still persistent issues which should be addressed this year. With more than 68% of people living in the rural areas, amendments should be made for better public healthcare services in the interiors of the country. Investments should be made in increasing the number of health professionals in the public health sector. Also, very little importance is given to the Emergency Medical Services which plays a crucial part in saving lives of people. The Government should invest in establishing skill centres which can train paramedics who are well versed in handling accidents and various other emergencies, as this will help the quality of emergency response services in our country. The government should allocate budget to develop technology that will help in reducing the time taken for an ambulance to reach the emergency. This can be in form of advanced GPS technology, live traffic monitoring and updates, fitness devices that can monitor health and transfer emergency signals in real time. If a push is given to the Emergency Medical Service (EMS) sector, it will, in turn help the healthcare professionals to save more lives."  ]]> https://biospectrumindia.com/news/22/10292/icmr-pfizer-to-collaborate-for-addressing-amr.html https://biospectrumindia.com/news/22/10292/icmr-pfizer-to-collaborate-for-addressing-amr.html Wed, 31 Jan 2018 14:50:00 +0530 The Indian Council of Medical Research (ICMR) and Pfizer are planning to set up a centre to address the growing threat of antimicrobial resistance in India. Pfizer has provided an initial grant of Rs 6.97 crore for this initiative, with a provision to scale up further as the programme expands. Pfizer and ICMR have signed a Memorandum of Understanding (MoU) for setting up the centre in New Delhi. The joint initiative will implement a series of interventions, ranging from AMR stewardship programmes for nursing homes, to scaling up the ongoing AMR surveillance network and creating awareness around responsible use of antibiotics. The Government of India views AMR as a key priority and in April 2017, it finalised country's National Action Plan on Antimicrobial Resistance (NAP-AMR). The 'Centre to Combat Antimicrobial Resistance' will be a nodal point to launch interventions in the three areas of Stewardship, Surveillance and Awareness. It would expand ICMR’s Antimicrobial Stewardship Programme across the country in a phased manner. The prime focus would be to embark on an awareness and advocacy programme to share information on antibiotic resistance, promote rational use of antibiotics, encourage infection control techniques and organise conferences and awards to recognise best practices. ]]> https://biospectrumindia.com/news/22/10283/usfda-approved-ciplas-hiv-drug-.html https://biospectrumindia.com/news/22/10283/usfda-approved-ciplas-hiv-drug-.html Tue, 30 Jan 2018 15:55:00 +0530 The pharmaceutical company, Cipla has received final approval from the US health regulator for tenofovir disoproxil fumarate tablets, used to treat HIV-1 infections in adults.  Cipla said it has received final approval from the United States Food and Drug Administration (USFDA) for tenofovir disoproxil fumarate tablets, 300 mg.  These tablets are AB-rated generic equivalents of Gilead Sciences' Viread Tablets, 300 mg, and are indicated in combination with other antiretroviral agents for the treatment of HIV -1 infection in adults and paediatric patients 12 years of age and older. Citing IMS Health data, the company said Viread Tablets, 300mg, had US sales of approximately USD 725 million for the 12-month period ending November 2017.   ]]> https://biospectrumindia.com/news/22/10274/fda-approves-lutathera-for-treating-pancreatic-neuroendocrine-tumors-pnets.html https://biospectrumindia.com/news/22/10274/fda-approves-lutathera-for-treating-pancreatic-neuroendocrine-tumors-pnets.html Mon, 29 Jan 2018 18:10:00 +0530 The Pancreatic Cancer Action Network (PanCAN) declared that the Food & Drug Administration (FDA) just approved Lutathera®. Lutathera is a medication effective for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including pancreatic neuroendocrine tumors (PNETs).  While the FDA has already approved similar drugs for neuroendocrine tumor patients in the United States, Lutathera takes treatment a step further by selectively delivering radiotherapy to the PNETs using a somatostatin analog.  Patients who were treated with Lutathera in the phase III clinical trial had a 79 percent reduction in risk of disease progression or death, as compared to patients treated with the standard of care.  PNETs make up about 6 percent of all pancreatic cancer diagnoses, and the majority of cases express somatostatin receptors. It's important to note that Lutathera has not been approved for, nor shown to be effective in, patients with the more common form of pancreatic cancer, adenocarcinoma.  Every treatment available today was approved through a clinical trial. PanCAN strongly recommends clinical trials at diagnosis and during every treatment decision. ]]> https://biospectrumindia.com/news/22/10272/govt-initiates-pulse-polio-programme-for-2018.html https://biospectrumindia.com/news/22/10272/govt-initiates-pulse-polio-programme-for-2018.html Mon, 29 Jan 2018 16:40:00 +0530 The government has recently launched Pulse Polio programme for 2018, generating concerns over any entry of polio virus from other countries. Between January 2015 and May 2016, a total of 14 sewage samples collected from different parts of the country tested positive for vaccine-derived polioviruses (VDPVs) . None of these VDPVs detected in the sewage infected any children, so far. According to WHO data,in 2016, Pakistan reported 20 wild poliovirus cases while Afghanistan saw 13 cases. The WHO has stated that international travellers carry the risk of spreading the virus. India was declared polio-free on 27 March 2014. Despite India being polio free, it has made cross border surveillance stringent. In India the last polio case was recorded on 13 January 2011. India has done two nationwide polio campaigns this year. Polio vaccination is being carried out at international borders and is a must for people travelling to polio affected countries. ]]> https://biospectrumindia.com/news/22/10262/ksdpl-gets-who-nod-to-export-drugs.html https://biospectrumindia.com/news/22/10262/ksdpl-gets-who-nod-to-export-drugs.html Thu, 25 Jan 2018 20:15:00 +0530 Kerela State Drugs and Pharmaceuticals Ltd (KSPDL) has recently received the Good Manufacturing Practice (GMP) certification from the World Health Organisation (WHO), and now the company is eligible to sell its medicines in the world market. The WHO accords GMP approval for maintaining international safety and quality standards in drug production.  KSDPL is undergoing modernisation to enhance its capacity and quality. Currently, the company is supplying medicines to Andhra Pradesh and Telangana, and Jan Aushadhi.  The LDF government has allocated Rs. 32 crore for implementing various development projects in KSDPL. A Non-Beta Lactam and an injection plants are nearing completion. The company produces around 50 varieties of medicines, including capsules, tablets, liquids, and powder. It has been mainly supplying medicines to the Kerala State Medical Service Corporation Limited (KSMSCL). ]]> https://biospectrumindia.com/news/22/10256/ntagi-gives-immunisation-approval-to-hpv-vaccine.html https://biospectrumindia.com/news/22/10256/ntagi-gives-immunisation-approval-to-hpv-vaccine.html Thu, 25 Jan 2018 14:00:00 +0530 The advisory body that recommends vaccines for India’s Universal Immunization Programme (UIP), National Technical Advisory Group on Immunization or NTAGI have given approval for the introduction of the Human papillomavirus (HPV) vaccine in the UIP. Currently, two HPV vaccines are available in India, developed by Merck Sharp & Dohme (MSD) and GlaxoSmithkline (GSK), while one vaccine developed by an Indian firm is in clinical trials. Back in 2012, the licences of the MSD and GSK vaccines were told to be revoked, because they were allegedly approved by the Drug Controller General of India (DCGI) without adequate clinical trials.  Around 24,000 pre-adolescent girls were given MSD and GSK vaccines in the trial, overseen by the Indian Council of Medical Research (ICMR) and DCGI. However, eight of these girls died during the trial. Thus the inclusion of these vaccines in the UIP will wait till the Supreme Court decides on the case.   ]]> https://biospectrumindia.com/news/22/10254/1st-orthopedic-de-novo-granted-by-the-fda-to-illuminoss-medical.html https://biospectrumindia.com/news/22/10254/1st-orthopedic-de-novo-granted-by-the-fda-to-illuminoss-medical.html Thu, 25 Jan 2018 12:30:00 +0530 Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) has announced its role in the successful granting of the first orthopedic de novo by the U.S. Food and Drug Administration (FDA). It allows IlluminOss Medical, Inc. to initiate commercialization in the U.S. of the Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.  IlluminOss Medical retained MCRA in August of 2016 to lead interactions and correspondence with the FDA for the Bone Stabilization System. The IlluminOss System is a PET balloon infused with a photodynamic monomer, which when exposed to light, polymerizes the monomer, resulting in a solid intramedullary (IM) rod. This is an important treatment option for the fixation and stabilization of actual and impending pathological fractures of the humerus through a minimally invasive procedure. ]]> https://biospectrumindia.com/news/22/10252/sebias-hydrashift-2-4-daratumumab-assay-got-fda-acceptance.html https://biospectrumindia.com/news/22/10252/sebias-hydrashift-2-4-daratumumab-assay-got-fda-acceptance.html Wed, 24 Jan 2018 16:35:00 +0530 Sebia, a world leader in multiple myeloma diagnostics testing and monitoring, announces that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Hydrashift 2/4 daratumumab assay. It is to be used with Hydragel IF, for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis.  This in vitro diagnostic (IVD) reagent mitigates the daratumumab-mediated interference seen in Immunofixation results for patients with multiple myeloma treated with DARZALEX® (daratumumab), a fully human monoclonal antibody that binds to CD38.  The Hydrashift 2/4 daratumumab Immunofixation assay is the result of collaboration between Sebia and Janssen Biotech to provide the clinical community with better tools to monitor patients with multiple myeloma in line with the International Myeloma Working Group’s (IMWG) latest recommendations. Sebia received development rights from Janssen and is the worldwide supplier of this assay. ]]> https://biospectrumindia.com/news/22/10251/who-grants-prequalification-to-bharat-biotechs-rotavirus-vaccine-rotavac.html https://biospectrumindia.com/news/22/10251/who-grants-prequalification-to-bharat-biotechs-rotavirus-vaccine-rotavac.html Wed, 24 Jan 2018 16:15:00 +0530 Bharat Biotech has announced that the World Health Organization (WHO Geneva) has awarded prequalification to the developing world’s first rotavirus vaccine, ROTAVAC®. The vaccine will prevent infant deaths and hospitalizations due to rotavirus diarrhea and was launched by the Narendra Modi, Prime Minister of India in New Delhi in March 2015 and is one of the first novel vaccines to be developed completely from a developing world country. WHO Prequalification is necessary for UN agencies and Gavi, the Vaccine Alliance to purchase the vaccine in partnership with developing countries and will help accelerate availability of the ROTAVAC® to the developing countries with the highest burden of disease. India has introduced ROTAVAC® into its national immunization program during 2016, with ~ 35 million doses delivered till date. Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech said, “We are honored and delighted to become the first rotavirus vaccine from the developing world and India to be WHO Prequalified. We feel proud to dedicate this innovated in India and Made in India vaccine to the world. The true impact of vaccines can be seen, when vaccinations are carried out in affected populations. The Government of India has given a big boost by making ROTAVAC® available to millions in India already." Bharat Biotech’s track record of life saving vaccines is a testimony to the company's long-standing commitment to make affordable vaccines for the developing world. ROTAVAC® has been supplied to low income countries at $ 1.0 / dose, with the feasibility for further ~30% price reductions, based on the procurement of around 100 million doses for these countries” Dr. Krishna Ella added.  ROTAVAC® was developed as a result of a multi country - multi partner collaborative model of Team science for over 2 decades.  This large public private social innovation partnership included the Government of India’s Department of Biotechnology (DBT), the Indian Council of Medical Research, the Indian Institute of Science (IISC), the All India Institute of Medical Sciences (AIIMS), the Translational Health Sciences and Technology Institute (THSTI), the Society for Applied Studies (SAS), Christian Medical College (CMC) Vellore, King Edwards Memorial Hospital (KEM) Pune, Stanford University School of Medicine, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), Johns Hopkins University and PATH. Dr. Roger I. Glass, Director of the Fogarty International Center at the U.S. National Institutes of Health, who helped shepherd the process said, “The novel Team science partnership that developed this vaccine serves as a useful model for others to follow. The result is an effective, yet economical, vaccine that has the potential to save thousands of children’s lives in Africa and elsewhere”. According to him Rotavirus is responsible for an estimated 36% of hospitalizations for childhood diarrhea around the world and for an estimated 200,000 deaths in low and middle income countries. WHO prequalification for ROTAVAC® is the result of a rigorous regulatory process since 2016. ROTAVAC® has been under development since the year 2000 necessitating investments of around USD 200 million towards product development and dedicated manufacturing infrastructure. The Genome valley facility has an installed manufacturing capacity of up to 200 million doses / year, is a scalable model ready to meet global demand. Dr. M.K. Bhan, Ex Secretary Department of Biotechnology, who isolated the ROTAVAC® 116E strain said “Core funding for the development of ROTAVAC® was received from the Gates Foundation, PATH and BIRAC- Department of Biotechnology Government of India, since the year 2000. Additional funding from agencies such as the Research Council of Norway, UK Department for International Development, have made this project a success.” Dr. Fred Cassels, Global Head of Enteric and Diarrheal Diseases at PATH’s Center for Vaccine Innovation and Access said, “PATH enthusiastically welcomes Bharat Biotech’s news about reaching this exciting and important milestone for ROTAVAC. As a longstanding partner in the development of the vaccine since 2001, we know that achieving WHO prequalification of ROTAVAC brings us even closer to meeting the critical public health goal of improving the supply of affordable rotavirus vaccines worldwide.” Rotavirus is the leading cause of severe diarrhea and death among children less than five years of age around the world. According to a recent study, 37 percent of the 578,000 childhood diarrheal deaths in 2013 were due to rotavirus, for a total of 215,000 rotavirus death globally. Vaccinations are an important part of global public health efforts to meet the Sustainable Developmental Goals of UNDP. Duncan Steele, deputy director on the Enteric Diarrheal Diseases team at the Bill & Melinda Gates Foundation said, “India’s leadership in developing and introducing its own rotavirus vaccine is commendable and emphasizes a national commitment to improving the health of it’s children. The advent of a locally manufactured, WHO prequalified rotavirus vaccine offers promise to protect children in India, Africa, the Americas and the rest of Asia from this debilitating disease.” The project to develop ROTAVAC® has resulted in more than 15 international publications in peer reviewed journals, including the pivotal phase III publication in Lancet in 2014 proving its comparable efficacy in the developing world. ROTAVAC® has 5 global patents, granted in countries such as India, USA, UK, South Africa, China, Nigeria, among several others.  Product registrations for ROTAVAC® are in process in more than 30 countries globally.   Bharat Biotech has successfully miniaturized the dose volume of ROTAVAC®, to 0.5 ml / dose and is presented in a ready to use format, requiring no further reconstitution, similar to oral polio vaccines. The product profile of ROTAVAC® has been optimally designed for the developing world by the developing world to aid ease of administration, reduced training requirements, and with the lowest cold chain footprint for an oral rotavirus vaccine in the world. The cold chain footprint has been reduced to ~3 cm3 / dose, resulting in significant savings in cold chain storage and distribution costs. The 0.5 ml dose volume also reduces the amount of spit ups by infants when the vaccine is administered. Harry B. Greenberg, Joseph D. Grant Professor of Medicine and Microbiology and Immunology, Stanford University School of Medicine said, “The development of ROTAVAC is a clear example of “Team Science” at its best with outstanding and critical collaborative contributions from scientists and clinicians from both India and the United States, as well as vital assistance from the Indian Government, the US National Institute of Health, Stanford University, PATH and the BMGF to name just a few members of the team. Perhaps most remarkable is the fact that this vaccine was developed, from start to finish, entirely in India by an Indian biotech company in collaboration with multiple Indian and international partners, specifically to meet a very major unmet health care need of India.” The Government of India has introduced Rotavirus Vaccines into the universal immunization programme, where the vaccine is provided free of charge to the entire birth cohort. However this introduction is limited to 9 states namely Odisha, Andhra Pradesh, Haryana, Himachal Pradesh, Assam, Tripura, Tamil Nadu, Madhya Pradesh, and Rajasthan. Diarrheal deaths and hospitalizations due to rotavirus infections are highly prevalent in all parts of India. Further expansion of the Universal Immunization Programme to the entire country will result in significant reductions in infant mortality rates and hospitalization costs for governments and private citizens alike.     ]]> https://biospectrumindia.com/news/22/10237/fda-grants-fast-track-status-for-sobi003-to-treat-sanfilippo-a-syndrome.html https://biospectrumindia.com/news/22/10237/fda-grants-fast-track-status-for-sobi003-to-treat-sanfilippo-a-syndrome.html Tue, 23 Jan 2018 15:15:00 +0530 Swedish Orphan Biovitrum AB (publ) (Sobi™) is an international specialty healthcare company dedicated to rare diseases. The company declared that, FDA has issued a Study may proceed letter for the first study in humans, thereby accepting the investigational new drug (IND) application for the drug candidate SOBI003. In addition, SOBI003 was granted Fast Track status by the FDA. SOBI003 is a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (MPS IIIA). MPS IIIA or Sanfilippo A syndrome is a progressive, life-threatening and rare inherited metabolic disorder affecting children already from a young age. SOBI003 was granted orphan designation by the European Commission for MPS IIIA in October 2016 and by the FDA in June 2017. The clinical study with SOBI003 is expected to start during 2018. ]]> https://biospectrumindia.com/news/22/10235/fda-approved-elancos-credelio-to-kill-ticks-and-fleas.html https://biospectrumindia.com/news/22/10235/fda-approved-elancos-credelio-to-kill-ticks-and-fleas.html Tue, 23 Jan 2018 11:15:00 +0530 Elanco is a division of Eli Lilly and Company, provides product and knowledge services to improve animal health in more than 70 countries around the world. The company announced the U.S.FDA approval of Credelio® (lotilaner). Credelio is a new monthly oral tick and flea treatment that is easy on dogs, but tough on ticks and fleas. This new tick and flea option for dogs contains the patented active ingredient lotilaner, which targets the nervous system receptors of ticks and fleas, not dogs.  Credelio is a small, tasty2 chewable tablet approved for puppies and dogs eight weeks of age and older and 4.4 pounds and greater.  In a field study, 100 percent of Credelio tablets were administered successfully and dogs accepted 94 percent of them when offered by hand, in an empty bowl, or with food. Credelio is also well accepted by a broad range of dog breeds. In clinical studies, Credelio killed 100 percent of fleas within 12 hours for the entire month. Elanco supports veterinarians with a wide range of parasiticide solutions. ]]> https://biospectrumindia.com/news/22/10231/fda-gives-nod-to-extend-the-use-of-qiagens-therascreen.html https://biospectrumindia.com/news/22/10231/fda-gives-nod-to-extend-the-use-of-qiagens-therascreen.html Mon, 22 Jan 2018 15:50:00 +0530 QIAGEN N.V. is a provider of sample and assay technologies for molecular diagnostics, applied testing, academic and pharmaceutical research. A biotechnology company announced that the U.S. Food and Drug Administration (FDA) has approved a PMA supplement extending the indications for use of QIAGEN's therascreen® EGFR RGQ PCR Kit as a companion diagnostic. It helps to guide the use of Boehringer Ingelheim's targeted therapy GILOTRIF® (afatinib) for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with non-resistant epidermal growth factor receptor (EGFR) mutations. The approval extends the labeling claim to include detection of EGFR mutations L681Q, G719X and S768I to aid the identification of NSCLC patients for whom GILOTRIF® (afatinib) is indicated.  The therascreen® EGFR RGQ PCR Kit now detects the most comprehensive panel of EGFR mutations in which the safety and efficacy of GILOTRIF® (afatinib) have been established. The kit provides reagents optimized for rapid and sensitive detection of 21 somatic mutations using the QIAamp DSP DNA FFPE Tissue Kit and the Rotor-Gene Q MDx instrument.   ]]> https://biospectrumindia.com/news/22/10226/oral-soluble-film-by-aquestive-therapeutics-to-treat-epilepsy-syndrome-.html https://biospectrumindia.com/news/22/10226/oral-soluble-film-by-aquestive-therapeutics-to-treat-epilepsy-syndrome-.html Fri, 19 Jan 2018 16:05:00 +0530 Aquestive Therapeutics, Inc. is a specialty pharmaceutical company that advances and commercializes medicines to solve critical healthcare problems. The company announced that the U.S. Food and Drug Administration (FDA) have accepted for review the company's New Drug Application for clobazam Oral Soluble Film (clobazam OSF).  Clobazam OSF is used for supportive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older. LGS accounts for about four percent of all cases of childhood epilepsy. The PDUFA (Prescription Drug User Fee Act) target date for completion of the FDA review is the third-quarter of 2018. Clobazam OSF is administered using Aquestive's proprietary PharmFilm drug delivery technology. Similar in size and thickness to a stamp, Aquestive's PharmFilm dissolves instantly after being placed on the tongue and can be administered without water, among other benefits.  Two multicenter controlled studies were conducted to evaluate the bioequivalence of clobazam OSF with clobazam tablets, a benzodiazepine currently on market, at the same dosage strengths. Based on the studies, clobazam OSF was demonstrated to be bioequivalent to clobazam tablets and have comparable safety. ]]> https://biospectrumindia.com/news/22/10213/jbcpl-received-european-gmp-approval-.html https://biospectrumindia.com/news/22/10213/jbcpl-received-european-gmp-approval-.html Wed, 17 Jan 2018 13:05:00 +0530 JB Chemicals & Pharmaceuticals Limited (JBCPL), is an Indian pharmaceutical company headquartered in Mumbai, Maharashtra, India. The company manufactures and markets pharmaceutical formulations, herbal remedies and APIs both domestically and to 30-plus countries worldwide, including the United States, Europe, Australia, South Africa, other developing countries, Russia and CIS. JB Chemicals & Pharmaceuticals declared the Medicines Authority of Malta has granted European GMP approval to its manufacturing facilities located at Panoli, in Gujarat. The company stated this approval is valid in entire European Union.  The Medicines Authority of Malta has accorded its approval to the company's manufacturing facilities for tablets, capsules, liquids for internal use and semi-solids.  According to company, the approvals will help to enhance its product basket and also improve contract manufacturing business in the market. ]]> https://biospectrumindia.com/news/22/10212/lt-governor-approves-aap-governments-quality-health-for-all-scheme.html https://biospectrumindia.com/news/22/10212/lt-governor-approves-aap-governments-quality-health-for-all-scheme.html Wed, 17 Jan 2018 12:55:00 +0530 Lt Governor Anil Baijal on Tuesday approved a Delhi government scheme for quality healthcare service for people of the city, without any income criteria. The scheme was passed by the AAP cabinet on December 12 and subsequently sent to Mr Baijal for approval. Chief Minister Arvind Kejriwal, took to Twitter to announce the development, saying, "Honble @LtGovDelhi approves 'Quality Health for all' scheme without income criteria. Thank u so much sir." An official from the Lt Governor's office said the approval was given post facto. The "Quality health for all" scheme, applicable to permanent residents of Delhi, pertains to providing patients specified high-end diagnostic (radiological) tests and surgeries free-of-cost at private hospitals in case of delay in government facilities. Mr Baijal on December 29 had concurred with the amendments to the Delhi Arogya Kosh (DAK) scheme, however, he had advised the government to retain some "income ceiling" so that the resources of the government are used to help the poor and the needy, and the "poor are not crowded out by the well-to-do". Arvind Kejriwal, reacting to it had said that if the income criteria was introduced, it would practically "kill" the scheme. Health Minister Satyendar Jain last week had said, that there are needy people and those who may fall above the ceiling limit too are tax-payers, so no one should be restricted from availing the service. "We cannot differentiate between the poor and rich while providing medicines to them for their wellness," he had said. The Delhi government, in a statement, later in the evening said, it wants to ensure that people "irrespective of their economic status get best health and education facilities". "Under the scheme, the government is currently facilitating 52 specified surgeries free-of-cost at private hospitals in Delhi-NCR. There is no income limit for residents of Delhi, who are allotted a date of surgery after 30 days of diagnosis at one of the 24 specified government hospitals in the city to avail the scheme," it said in a statement. The specified surgeries include heart bypass, cataract surgery and 17 types of kidney operations. "Besides Aadhaar cards, patients can submit voter identity card or driving licence to avail the services," it added. So far, "more than 12,000 people" have availed the scheme, on being referred from Delhi government hospitals, mohalla clinics and polyclinics last year, the government said. Delhi is one of the fastest growing metropolis with a population of more than 16 million, the government said.   ]]> https://biospectrumindia.com/news/22/10210/india-israel-to-enhance-homeopathy-research.html https://biospectrumindia.com/news/22/10210/india-israel-to-enhance-homeopathy-research.html Wed, 17 Jan 2018 11:25:00 +0530 India and Israel has signed a memorandum of understanding (MoU) to enhance cooperation and boost research in homoeopathy, a system of alternative medicine. The pact has been signed between the Central Council for Research in Homoeopathy, Ministry of AYUSH, and Centre for Integrative Complementary Medicine, Shaare Zedek Medical Centre, Jerusalem. The MoU envisages cooperation in the field of research in homoeopathic medicine. It includes an establishment of a joint working group. The MoU is a part of the nine agreements signed between the two countries after talks between Prime Minister Narendra Modi and his Israeli counterpart Benjamin Netanyahu. Israel is planning to invest $68.6 million to boost cooperation with India in a number of areas over a period of four years. ]]> https://biospectrumindia.com/news/22/10199/punjab-govt-to-open-health-and-wellness-centres.html https://biospectrumindia.com/news/22/10199/punjab-govt-to-open-health-and-wellness-centres.html Tue, 16 Jan 2018 11:55:00 +0530 Punjab Government has decided to open health wellness centres in different parts of the State. Punjab Health Minister Brahm Mohindra has stated that a total of 2,950 such centres will be opened across the state in a phased manner. The operational cost to run each centre would be around Rs 17 lakhs, where doctors would be the visiting faculty from nearby community health centres. To ensure punctuality and sense of responsibility of medical officers towards patients, State Government has decided to install biometric attendance system in all government hospitals. Medicine shops would be opened at 22 district hospitals while five trauma centres would also be established. State Government also unveiled plan to roll out 50 new ambulances, which will be equipped with critical life-saving equipment. The State Government has already established e-raktkosh in all 45 government blood banks which is one of its kinds within the country. Public can access information on blood availability status as per blood group, blood bank and districts with the help of e-raktkosh. ]]> https://biospectrumindia.com/news/22/10196/jj-signs-mou-with-maharashtra-govt-for-improving-healthcare.html https://biospectrumindia.com/news/22/10196/jj-signs-mou-with-maharashtra-govt-for-improving-healthcare.html Mon, 15 Jan 2018 17:00:00 +0530 Johnson & Johnson India has entered into a collaboration with the Government of Maharashtra to implement focused disease interventions that have the potential to significantly improve the health of people and strengthen healthcare in the state. A Memorandum of Understanding (MoU) for the partnership has been signed in the presence of the Minister of Public Health and Family Welfare, Government of Maharashtra, Dr Deepak Sawant in Mumbai recently. The Government of Maharashtra and Johnson & Johnson India will work together to address pressing public health issues such as tuberculosis (TB), maternal and child health, infection prevention, diabetes, obesity and menstrual hygiene and will support healthcare professionals and nurses in the state to further develop their skills in these areas.  A focused program to increase awareness and early diagnosis of TB amongst mineworkers and their families, a group that is at increased risk of developing the disease, will be implemented under the aegis of the Revised National Tuberculosis Control Program (RNTCP).  This association will also bring about designing of new programmes and strengthening existing programs to help address public health issues. ]]> https://biospectrumindia.com/news/22/10193/india-registers-significant-decline-in-under-five-child-mortality-rate-srs-bulletin.html https://biospectrumindia.com/news/22/10193/india-registers-significant-decline-in-under-five-child-mortality-rate-srs-bulletin.html Mon, 15 Jan 2018 13:05:00 +0530 J P Nadda, Union Minister of Health and Family Welfare expressed happiness over the just released SRS bulletin (2016) as India registered a significant decline in under-five child mortality. According to the bulletin, under-five child mortality (U5MR) of India showed an impressive decline by 9%, a 4 points decline from 43 per 1000 in 2015 to 39 in 2016. The rate of decline has doubled over the last year. Not only this, number of under-five deaths for the first time in the country have come down to below 1 million with nearly 120,000 fewer under-five deaths in 2016 as compared to 2015. Most of the states have shown good progress in reduction of under-five child mortality from the previous year, except Chattisgarh, Delhi and Uttarakhand, which have shown a slight increase over the previous year and Telangana, which has shown no change in 2016. Congratulating all those associated with this remarkable feat, Nadda stated that the results signify that the strategic approach of the Government is yielding dividends and the efforts of focusing on low performing states is paying off. He stated that India with the current rate of decline of U5MR is on track to meet the SDG target for under-five child mortality of 25 by 2030. The Health Minister further said, “Under the visionary leadership and guidance of the Hon. Prime Minister Shri Narendra Modiji, the government is committed to advancing the agenda of Universal Health Coverage in the country and its initiatives like Mission Indradhanush and Intensified Mission Indradhanush, with their focused approach, are significantly turning the tide in favour of India.” “These remarkable achievements in merely one year are the result of countrywide efforts to increase the health service coverage through various initiatives of the Government that include strengthening of service delivery; quality assurance; RMNCH+A interventions; strengthening human resources and community processes; information and knowledge; drugs and diagnostics, and supply chain management, etc.”, he said According to the SRS Bulletin, the gender gap in India for child survival is reducing steadily; the gender difference between female and male under-five mortality rates has now reduced to 11% which was as high as 17% in 2014. The current under-five mortality for male child is 37 per 1000, while for female child is 41 per 1000 live births. Amongst the bigger states, seven states (Chattisgarh, Delhi, Gujarat, MP, Odisha, Tamil Nadu Telangana) have reversed the gender gap in survival of female child, while four of these have reversed the gender gap for under-five survival. These are Madhya Pradesh, Chhattisgarh, Gujarat and Tamil Nadu. Telangana, West Bengal, Odisha, Punjab and Delhi have depicted less than 5% gap in mortality of female child and are within striking distance to reverse the gender gap. The maximum gender gap in survival of under-five for female child is in Bihar (46% higher mortality for female child), followed by Haryana (23%), Kerala (20%), Assam, Karnataka (19%) and Rajasthan (17%). Further, the SRS Bulletin also shows that the neonatal mortality rate has reduced by 1 point from 25 per 1000 live births to 24 per 1000. ]]> https://biospectrumindia.com/news/22/10191/fda-grants-approval-to-gsks-fluarix-quadrivalent-.html https://biospectrumindia.com/news/22/10191/fda-grants-approval-to-gsks-fluarix-quadrivalent-.html Mon, 15 Jan 2018 11:15:00 +0530 GlaxoSmithKline (GSK) is leading research-based pharmaceutical and healthcare company. GSK announced about the  receiving approval from the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research expanding the indication for FLUARIX® QUADRIVALENT (Influenza Vaccine) to include use in persons 6 months and older. Seasonal influenza (the "flu") is a contagious respiratory illness, caused by flu viruses. There are two main types of flu viruses, A and B, that spread between people and can cause mild to severe illness. According to the US Centers for Disease Control and Prevention (CDC), the best tool available to help protect yourself and those around you against the flu is to get vaccinated. Prior to the FDA approval, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses, in persons 3 years of age and older. With this approval, providers will be able to use the same dose of FLUARIX® QUADRIVALENT (15 ug of hemagglutinin per virus strain in 0.5 mL) to cover all eligible persons from 6 months of age and up. The supplemental Biologics License Application was based on a Phase III pivotal study of the efficacy of FLUARIX® QUADRIVALENT in children 6 months through 35 months of age and on two supportive studies. ]]> https://biospectrumindia.com/news/22/10184/india-and-malaysia-meets-for-cooperation-in-the-field-of-traditional-systems-of-medicine.html https://biospectrumindia.com/news/22/10184/india-and-malaysia-meets-for-cooperation-in-the-field-of-traditional-systems-of-medicine.html Fri, 12 Jan 2018 11:30:00 +0530 The 5th Bilateral Technical Meeting on cooperation in the field of Traditional Systems of Medicine between India and Malaysia was recently held at New Delhi. It was a part of agreement signed between both countries in 2010. The Meeting was presided by Pramod Kumar Pathak, Joint Secretary, Ministry of AYUSH from Indian side and Deputy Director General Health (Medical), Ministry of Health Malaysia. Vaidya Rajesh Kotecha, Secretary, Ministry of AYUSH stated, “Any initiative from Malaysian side for promotion and propagation of Traditional Systems of Medicine and Homeopathy is welcomed and Ministry of AYUSH is ready to offer its full support.” The Meeting had discussed the following agenda:- (a)  Establishment of Ayurveda Chair in University of  UTAR, Malaysia (b)  Professional training in Panchakarma therapy for Malaysian experts  in India (c)  The evaluation of safety and efficacy of combination Ayurvedic/ traditional products for clinical trials. (d)  Safety evaluation of Ayurvedic products based on Good Laboratory Practices (GLP) (e)  Bilateral MoU between National Medicinal Plants Board (NMPB), Ministry of AYUSH and Malaysia for Cooperation in the field of Medicinal Plants. (f)   Registration of Homeopathic Practitioner and their capacity building module in Malaysia.  The Malaysian side briefed about recent development in the field of Traditional Medicine in their country. It was informed that Traditional and Complementary Medicine (T&CM) Council has been constituted to overlook various activities related to T&CM Systems of Medicine. They expressed their keen desire for capacity building programmes for their experts in India to understand analytical parameters with regard to Indian Medicine and for Panchkarma courses being conducted in India.  Ministry of AYUSH highlighted the issues of registration of AYUSH practitioners and products in Malaysia. It was informed that there exists robust system of regulation in the country for AYUSH product, practices and providers in India which could be shared with Malaysian side for reference purpose. Ministry intends to enhance cooperation for designing and developing the policies and strategies in the field of Traditional Medicine in Malaysia.     ]]> https://biospectrumindia.com/news/22/10182/cabinet-approves-mou-between-india-and-canada-in-the-field-of-st.html https://biospectrumindia.com/news/22/10182/cabinet-approves-mou-between-india-and-canada-in-the-field-of-st.html Fri, 12 Jan 2018 11:15:00 +0530 The Union Cabinet chaired by Prime Minister has approved a Memorandum of Understanding (MoU) with Canada for cooperation in the field of Science & Technology.  The MoU will provide a mechanism and help to foster scientific cooperation between R&D and academic institutions of India and Canada. It was recently concluded by the Department of Science and Technology with the Natural Sciences and Engineering Research Council (NSERC) of Canada. Under this MoU, the India-Canada Centre for Innovative Multidisciplinary Partnership to Accelerate Community Transformation and Sustainability (IC-IMPACTS) programme will be supported to promote India-Canada multidisciplinary research partnerships. Also, the R&D projects will be aimed at accelerating social transformation by providing solutions through application of science and technology. The participants will include researchers from scientific organizations, academia and R&D laboratories from India and Canada. This will also help to develop institutional networking and support the establishment of connections between scientific organizations, scientists and specialists of India and Canada. The MoU was concluded in pursuance to the inter-governmental Agreement for Scientific and Technological Cooperation between the India and Canada concluded in November 2005. ]]> https://biospectrumindia.com/news/22/10181/u-s-fda-approves-boston-scientifics-spinal-cord-stimulator-system-.html https://biospectrumindia.com/news/22/10181/u-s-fda-approves-boston-scientifics-spinal-cord-stimulator-system-.html Thu, 11 Jan 2018 17:50:00 +0530 Boston Scientific Corporation announced that the U.S. Food and Drug Administration (FDA) have approved the Spectra WaveWriter™ Spinal Cord Stimulator (SCS) System. It is the first and only system approved by the FDA to simultaneously provide paresthesia-based and sub-perception therapy. The system allows physicians and patients to combine therapeutic options, customize therapy and capture real-time feedback designed to treat chronic and devastating pain successfully. SCS works by sending low electrical pulses, which vary in frequency, pulse width and amplitude, to the spinal cord to interrupt pain signals. Paresthesia-based therapy provides pain relief with a light tingling sensation while sub-perception therapy works without that sensation. With the Spectra WaveWriter System, patients can choose to combine both of these therapies to target one specific area of pain or use each therapy as needed to best manage multiple areas of pain. Patients provide real-time feedback using the system's remote control. Together, these features benefit patients by addressing each individual's unique pain relief needs. The Spectra WaveWriter System was developed with more than a decade of clinical research focused on optimizing sub-perception and delivering multiple therapies intended for more effective, long-term pain relief. These studies include the WHISPER study and the PROCO study. The PROCO study was a multi-center, prospective, double-blind, randomized study in which patients acted as their own control. This study established in de novo patients that similar pain relief and improvement in quality of life measures are achieved independent of the type of frequency (from 1 kHz up to 10 kHz) used in sub-perception SCS therapy when the proper target and dose are identified.  The WHISPER study is a multi-center, prospective, cross-over, randomized, and controlled study evaluating the long-term safety and effectiveness of sub-perception SCS pain relief therapy. ]]> https://biospectrumindia.com/news/22/10173/environment-ministry-conducts-national-conference-on-welfare-of-laboratory-animals-.html https://biospectrumindia.com/news/22/10173/environment-ministry-conducts-national-conference-on-welfare-of-laboratory-animals-.html Wed, 10 Jan 2018 12:45:00 +0530 A one-day National Conference on Welfare of Laboratory Animals was organised by CPCSEA, Ministry of Environment, Forest and Climate Change, with the theme of “Implementation of 3Rs (Replacement, Reduction and Refinement) while using animals in academic research and regulatory testing in India” The conference deliberated upon elaborating the understanding of animal use in academics, as well as regulatory testing and evaluating the use of alternatives, wherever animals can be exempted from testing.  The conference also laid emphasis on the issue of ethical use of animals in academics and regulatory testing in India. The discussions were focussed on evaluating the possibilities of exemption of animal experiments in academics and regulatory testing. Dr. Subeer Majumdar, Director, National Institute of Animal Biotechnology (NIAB); Dr. K. Muralidhar Professor, School of Life Sciences, University of Hyderabad; Dr. Y.K Gupta, Professor and Head, Department of Pharmacology, AIIMS and Dr. Alok Dhawan, Director, Indian Institute of Toxicology Research were present at the conference and was chaired by A.K Jain, Additional Secretary, MoEF&CC and Dr. G. N. Singh, Drug Controller General of India (DCGI). The conference was also attended by representatives from animal welfare organisations like PFA, and PETA India, to encourage exchange of views between the stakeholders. The CPCSEA is mandated to alleviate pain & suffering to the laboratory animals before, during or after the performance of experiments on them. ]]> https://biospectrumindia.com/news/22/10166/brainstorm-certified-with-gmp-approval.html https://biospectrumindia.com/news/22/10166/brainstorm-certified-with-gmp-approval.html Mon, 08 Jan 2018 17:25:00 +0530 BrainStorm Cell Therapeutics Inc, a leading developer of adult stem cell technologies for neurodegenerative diseases. The company has made announcement that it received Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health (MoH) for its Israeli contract manufacturing facility. The GMP certificate confirms the company's manufacturing site compliance with Israeli GMPs which are recognized as equivalent with the European Union's GMP. This approval paves the way for the company's application to the Israel MoH for the treatment of ALS patients in Israel for a fee, under the newly introduced Hospital Exemption regulation. ALS (amyotrophic lateral sclerosis) is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord.  NurOwn is a novel advanced stem cell therapy now being studied in a multi-site Phase 3 pivotal trial at leading ALS centers. The company is trying to make it available to patients through innovative regulatory pathways. The GMP certificate was granted after an inspection of BrainStorm's contract manufacturing facilities. ]]> https://biospectrumindia.com/news/22/10163/evenitys-application-accepted-by-european-medicines-agency-.html https://biospectrumindia.com/news/22/10163/evenitys-application-accepted-by-european-medicines-agency-.html Mon, 08 Jan 2018 12:40:00 +0530 Amgen and UCB have been working together under a collaboration and license agreement to research, develop and market antibody products targeting the protein sclerostin. Together, Amgen and UCB announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for EVENITY (romosozumab) for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. If approved in Europe, EVENITY will be a novel osteoporosis treatment that increases bone formation and reduces bone resorption simultaneously to increase bone mineral density (BMD) and reduce the risk of fracture.  The MAA for EVENITY is based on results from three pivotal Phase 3 studies: FRAME, including 7,180 postmenopausal women with osteoporosis; ARCH, including 4,093 postmenopausal women with osteoporosis at high risk for fracture; and BRIDGE, including 245 men with osteoporosis. The agency will evaluate the clinical benefit: risk profile of EVENITY in these three pivotal studies, including the potential to increase BMD and reduce the risk of fractures in women with osteoporosis, as well as the cardiovascular safety signal seen in the ARCH study. ]]> https://biospectrumindia.com/news/22/10137/india-sri-lanka-to-sign-agreement-to-promote-traditional-medicines.html https://biospectrumindia.com/news/22/10137/india-sri-lanka-to-sign-agreement-to-promote-traditional-medicines.html Wed, 03 Jan 2018 12:50:00 +0530 Indian government is planning to sign a memorandum of understanding (MoU) with Sri Lanka for cooperation in areas of traditional systems of medicine & Homoeopathy. The proposed MoU will be inked between India’s Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) and Sri Lanka’s Ministry of Health, Nutrition and Indigenous Medicine. The financial resources necessary to conduct activities under the MoU will be met from the existing allocated budget under this ministry's Central Sector Scheme for promotion of International Cooperation in AYUSH. The main objectives of this agreement will include regulation of teaching, practice, drugs and drugless therapies, Traditional Medicine and Homeopathy; exchanging experts for training of practitioners, paramedics, scientists, teaching professionals and students in Traditional Systems of Medicine and Homeopathy; accommodating interested scientists, practitioners, paramedics and students in institutions for research, educational and training programmes on Traditional Medicine; mutual recognition of officially recognised systems of medicine, educational qualifications in Traditional Systems of Medicine and Homeopathy, pharmacopoeias and formularies; and setting up of Academic Chairs on Traditional Systems of Medicine and Homeopathy. ]]> https://biospectrumindia.com/news/22/10128/centre-states-should-invest-more-in-healthcare-venkaiah-naidu.html https://biospectrumindia.com/news/22/10128/centre-states-should-invest-more-in-healthcare-venkaiah-naidu.html Tue, 02 Jan 2018 16:00:00 +0530 Vice President Venkaiah Naidu has urged the Centre and state governments to invest more in the healthcare sector and educate people to get health insurance. Stating that providing proper medical service is the need of the hour, Naidu on Saturday said private sector investments and public-private Partnership (PPP) model should be encouraged more for the betterment of healthcare in the country. “The central and the state government must together spend more in the health sector. Also people should be educated about getting health insurance. Many people in India are worried about the cost but health insurance is very much required,” Naidu said at the 11th Global Healthcare Summit organised by the American Association of Physicians of Indian Origin (AAPI) here. “We must all focus more on the service. The medical service in India is the need of the hour. India is still lagging behind in spite of a lot of advancement in medication. The centre is encouraging private sector in the medical healthcare sector. We must also go with the PPP model,” he added. Claiming that India has the potential to become a medical tourist centre in the future, the Vice President said accessibility and affordability of healthcare should be ensured as a large section of the country’s population belongs to the middle and lower-middle class. Naidu claimed that the modern day lifestyle is creating a lot of health problems and stressed the need to raise awareness about its adverse effects among the people. “The modern day lifestyle is creating serious health hazards. The doctors should indicate the people to go back to their cultural roots and follow the disciplined, systematic lifestyle. Diabetes is a major challenge faced in the country,” he said. He also urged the Indian medical practitioners staying abroad to come back to the country and help the society as all the opportunities are now available here. “I would be happier if you people can come back to India and do something to help the society. Earlier the opportunity was very less here so people went to different parts of the globe for work. But now everything is available in India.” Naidu added. ]]> https://biospectrumindia.com/news/22/10126/health-ministry-introduces-professional-data-portal.html https://biospectrumindia.com/news/22/10126/health-ministry-introduces-professional-data-portal.html Tue, 02 Jan 2018 11:50:00 +0530 The Union Health Ministry has recently launched the Allied and Health care Professional Database which will can help the government track the number of professionals and streams of allied and health care professions in the country. The allied and health care professionals' can visit the portal and provide basic personal, qualification and professional information. The portal will then send an auto-generated email for verification and will provide an enrolment reference number for further usage. According to the ministry, more than 3, 000 professionals have already registered on the portal during the testing phase. The portal has a capacity of capturing more than 10 lakh allied and healthcare professionals' data. This portal may further prove helpful in expediting the envisaged processes viz. licensing of professionals, workforce policy planning, and bringing transparency in the system by maintaining standards of educational and clinical practice. Union Health Secretary Preeti Sudan has mentioned that the portal is a provisional measure taken by the Ministry to track and reach out to all the allied and health care professionals in the country till a statutory body is established ]]> https://biospectrumindia.com/news/22/10119/biocon-mylans-biosimilar-gets-brazilian-approval.html https://biospectrumindia.com/news/22/10119/biocon-mylans-biosimilar-gets-brazilian-approval.html Fri, 29 Dec 2017 15:50:00 +0530 The biosimilar trastuzumab has been approved by ANVISA, the Brazilian regulatory agency. Co-developed by Biocon and Mylan, this is the first biosimilar trastuzumab to be approved in Brazil and is indicated for the treatment of overexpressing HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer and HER2-positive advanced gastric cancer. A leading Brazilian pharmaceutical company, Libbs Farmaceutica will commercialize the product in Brazil under the brand name Zedora, which will provide affordable access to a cutting-edge biologics therapy for patients in Brazil. Biocon and Mylan are responsible for the development of biosimilar trastuzumab. While currently the trastuzumab will be manufactured by Biocon and supplied to Libbs for commercialization in Brazil; over a period of time the technology will be transferred to Libbs and the public partner Butantan through a Productive Development Partnership (PDP). Libbs have already built the biotechnological site to manufacture Zedora for the Brazilian market. Biocon and Mylan's biosimilar trastuzumab is also under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It is already approved in several other countries around the world, including India, where it is providing increased access to this more affordable biologic for cancer patients.   ]]> https://biospectrumindia.com/news/22/10112/fear-of-double-taxation-forces-lupin-to-knock-courts-door.html https://biospectrumindia.com/news/22/10112/fear-of-double-taxation-forces-lupin-to-knock-courts-door.html Thu, 28 Dec 2017 15:35:00 +0530 Lupin Ltd., the BSE listed Mumbai-headquartered pharmaceutical company, has dragged the Government of India to court, claiming the stock lying in its godowns could face double taxation when it's sold. Lupin, like many other pharma companies, is worried that some of the stock lying in its godowns could face double taxation due to goods and services tax (GST) regulations. The old pile of medicines, ointments or any other drugs, on which previous taxes such as sales tax and VAT have already been paid, could now be subjected to GST as well. This is mainly because many drugs and medicines that were manufactured before GST kicked in, were actually rolled out this year, and could carry an expiry date later than June 2018. Under GST, there's a concept of transitional credit wherein taxes paid under the old regime can be set off against the GST liability. So, the pharma companies that bought medicines or other drugs from their vendors or third party manufacturers without corresponding invoices before July 1 are not entitled to set off the taxes paid on them against their GST liability after 12 months, setting the deadline for June 30, 2018. Lupin did not respond to an email query till the time of going to press.   "The question is can a law dictate how business is conducted and whether it can lay restrictions on the time frame of selling any products," asked Abhishek A Rastogi, partner at Khaitan & Co. ]]> https://biospectrumindia.com/news/22/10093/health-ministry-to-develop-plan-for-curbing-hepatitis.html https://biospectrumindia.com/news/22/10093/health-ministry-to-develop-plan-for-curbing-hepatitis.html Tue, 26 Dec 2017 11:55:00 +0530 The Union health ministry plans to assess the impact of the Universal Immunisation Programme (UIP), launched 10 years ago for Hepatitis B, on the population. The government introduced Hepatitis B vaccines in the UIP in 2007-2008. Nearly 119,000 cases of all cause viral hepatitis were reported in India in 2012. The Integrated Disease Surveillance Programme of the National Centre for Disease Control received notification of over 290,000 cases of acute viral hepatitis in 2013. Under the health ministry’s plan, the Indian Council of Medical Research (ICMR) aims to identify the barriers leading to low Hepatitis B coverage under UIP and study the impact of the immunization done over the years. The health ministry is developing a comprehensive integrated three-year National Action Plan for Viral Hepatitis (NAPVH) with the key objective of providing an actionable framework of evidence based, priority interventions to support the national response for prevention, control and management of viral hepatitis in the country. Under the plan, studies will be conducted to understand the efficacy of alternative medicine in preventing and treating viral hepatitis, comparison of indigenous and Chinese hepatitis vaccines in clinical trials and understand the modes of transmission of viral hepatitis B. ]]> https://biospectrumindia.com/news/22/10079/mou-between-india-and-italy-approved-by-the-cabinet.html https://biospectrumindia.com/news/22/10079/mou-between-india-and-italy-approved-by-the-cabinet.html Thu, 21 Dec 2017 11:05:00 +0530 The Union Cabinet chaired by Prime Minister has given its ex-post-facto approval for a Memorandum of Understanding (MoU) between India and Italy on cooperation in the field of Health and Medical Sciences.  The MoU was signed on 29th November, 2017 in New Delhi. The MoU covers the cooperation in the areas like Exchange & training of medical doctors, officials, other health professionals and experts; Assistance in development of human resources and setting up of health care facilities; Short term training of human resources in health; Regulation of pharmaceuticals, medical devices and cosmetics and exchange of information thereon; Promotion of business development opportunities in pharmaceuticals; Procurement of generic and essential drugs and assistance in sourcing of drug supplies; Procurement of health equipment and pharmaceutical products; Collaboration in the prevention of NCDs of .mutual interest, such as neurocardiovascular diseases, cancer, COPDs, mental health and dementia, with an emphasis on SDG3 and related factors; Collaboration in the field of climate change impact on communicable diseases and vector borne diseases; Nutritional aspects of food intake, including malnutrition (over nutrition and undernutrition) in the light of the SDG2 and organization of nutritional services; Safety of production, transformation, distribution and food delivery; Research and training of food industry operators; Information and communication to citizens on hygiene and food safety and healthy eating habits. A Joint Working Group (JWG) will be set up to further elaborate the details of cooperation and to oversee the implementation of this Memorandum of Understanding (MoU).   ]]> https://biospectrumindia.com/news/22/10078/mou-between-india-and-cuba-approved-by-the-cabinet.html https://biospectrumindia.com/news/22/10078/mou-between-india-and-cuba-approved-by-the-cabinet.html Thu, 21 Dec 2017 10:50:00 +0530 The Union Cabinet chaired by Prime Minister has given its ex-post-facto approval for a Memorandum of Understanding (MoU) between India and Cuba on cooperation in the field of Health and Medicine.  The MoU was signed on 06th December, 2017 in New Delhi and covers the areas of cooperation in areas like Exchange & training of medical doctors, officials, other health professionals and experts; Assistance in development of human resources, health services and setting up of health care facilities; Short term training of human resources in health; Regulation of pharmaceuticals, medical devices and exchange of information; Promotion of business development opportunities in pharmaceuticals and others identified by parties; Procurement of generic and essential drugs and assistance in sourcing of drug supplies; Procurement of health equipment and pharmaceutical products and any other area of cooperation as may be mutually decided upon.  A Joint Working Group (JWG) will be set up to further elaborate the details of cooperation and to oversee the implementation of this MoU. ]]> https://biospectrumindia.com/news/22/10073/apotex-to-halt-drugs-shipping-to-eu.html https://biospectrumindia.com/news/22/10073/apotex-to-halt-drugs-shipping-to-eu.html Wed, 20 Dec 2017 13:45:00 +0530 Medicine and Healthcare products Regulatory Agency (MHRA) in UK has banned Apotex Research Pvt Ltd from shipping drugs made at its plant in Bengaluru to the EU after inspectors raised concerns about the potential for cross contamination. The inspection last month identified failures in the cross contamination controls applied by the manufacturer resulting in a risk of cross contamination above Permitted Daily Exposure (PDE) from some products. The agency has also recommended withdrawal of the site’s good manufacturing practice (GMP) certificate. MHRA has advised member states to contact the site to determine the level of risk associated with specific products related to market. The only products not covered by the ban are those likely to be in short supply. Apotex will be able to continue supply if the marketing authorization holder gains written approval from MHRA in the intended market. ]]> https://biospectrumindia.com/news/22/10041/dr-subash-bhamre-inaugurates-49th-annual-conference-of-snmicon.html https://biospectrumindia.com/news/22/10041/dr-subash-bhamre-inaugurates-49th-annual-conference-of-snmicon.html Fri, 15 Dec 2017 14:50:00 +0530 Dr. Subash Bhamre, Raksha Rajya Mantri has inaugurated a four day 49th Annual Conference of the Society of Nuclear Medicine – India SNMICON recently. Dr. Anshu Rajneesh Sharma, President, Society of Nuclear Medicine (India); Prof (Dr.) Randeep Guleria, Director, All India Institute of Medical Sciences (AIIMS), Delhi and others also spoke on the occasion. Dr. Bhamre said that advances in medical science have led to significant improvements in our quality of life. Increase in life expectancy, cure of hitherto incurable diseases and the ability to understand the human body can all be attributed to these advancements. The role of nuclear medicine has gained significant momentum over the past few years. He said, “A dedicated research laboratory of DRDO Life Cluster, Institute of Nuclear Medicine and Allied Sciences (INMAS) is making considerable contribution in the research of nuclear medicine, thereby exemplifying the peaceful use of nuclear energy. INMAS has always taken a lead with academic developments in the areas of radiation and imaging sciences. The contributions of INMAS are a clear example of how research supported by the Ministry of Defence has significant benefits for society at large.” Dr. Bhamre informed that, scientists of INMAS are active members for various SNM activities, be it educational programmes, policy drafting or training activities. He called for furthering the close association of INMAS with SNM, hospitals and national universities along with industries and private players to advance nuclear medicine’s diagnostic and therapeutic applications through research and training.   ]]> https://biospectrumindia.com/news/22/10027/stop-street-drug-alternative-fda-warns.html https://biospectrumindia.com/news/22/10027/stop-street-drug-alternative-fda-warns.html Wed, 13 Dec 2017 14:15:00 +0530 The U.S. Food and Drug Administration posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a "snortable" chocolate powder, for selling unapproved new drugs and misbranded drugs.  The warning letter explains how the claims made in the promotional materials for Legal Lean Syrup and Coco Loko demonstrate that the products are intended to be used as alternatives to illicit street drugs and that the products, as labeled and marketed, may pose safety concerns. Drug abuse is a serious public health issue, and the FDA is concerned that products like Legal Lean Syrup and Coco Loko encourage drug abuse in individuals, including minors. Street drug alternatives are products that claim to mimic the effects of recreational drugs and are intended to be used for recreational purposes to affect psychological circumstances.  "As a physician and a parent, I'm deeply troubled by the unlawful marketing of these potentially dangerous products, especially since they are so easily accessible by minors.Encouraging the use of snortable chocolate as an alternative to illegal street drugs is not acceptable There are very real consequences to snorting any powder, not to mention the societal dangers of promoting drug abuse," said FDA Commissioner Scott Gottlieb, M.D. He added further"At a time where drug addiction is threatening the fabric of American society, we must take action when we see efforts that may further fuel illicit drug abuse. We'll continue to vigorously target bad actors that sell unapproved products, including products that contain undeclared drug ingredients."  Coco Loko is described as a "snuff" and promoted to be "snorted" (inhaled intranasally). Intranasal administration of a powder substance can trigger spasms of the vocal cords making it difficult to speak or breathe (laryngospasm) or tightening of the muscles that line the airways in the lungs (bronchospasm) and may also induce or exacerbate asthma. The ingredients listed on the product label for Coco Loko also include taurine and guarana, neither of which has been evaluated for intranasal administration.   An FDA laboratory analysis found that Legal Lean Syrup contained the active pharmaceutical ingredient doxylamine, which was not included in the product labeling. FDA-approved products that contain doxylamine warn against its use with alcoholic beverages and instruct people with certain medical conditions to consult a physician before use. Furthermore, the inclusion of undeclared doxylamine in Legal Lean Syrup poses a potentially serious risk to those who have already had adverse reactions to this ingredient and whose physicians have advised them to avoid it. In general, products that contain undeclared drug ingredients pose a serious health risk, because consumers with underlying medical issues may take the products without knowing of any potential side effects or interactions. The companies have 15 days to respond to the FDA and correct the issues noted, or they may face regulatory action. ]]> https://biospectrumindia.com/news/22/10024/birac-puts-focus-on-anti-snake-venom-production.html https://biospectrumindia.com/news/22/10024/birac-puts-focus-on-anti-snake-venom-production.html Wed, 13 Dec 2017 11:05:00 +0530 Biotechnology Industry Research Assistance Council (BIRAC) will soon begin research for developing novel tools, technologies and processes pertaining to snake bite problem and product optimization/scale-up on Anti-snake venom. BIRAC's initiative in this regard is significant as India is estimated to have the highest snakebite mortality in the world. It is a common and frequently devastating environmental and occupational disease, especially in rural areas of tropical developing countries and is responsible for tens of thousands of deaths and disabilities every year. BIRAC has now invited research proposals on development of novel and alternate ways of anti-snake venom (ASV) production; development of new diagnostics kits for the identification of the snake biting species; and characterization, evaluation and validation facility for ASV.   The progamme will focus on cost effective, novel and innovative approaches. The focus will also be on generating ASV with better product profiles and greater cost effectiveness than current products in the market. This programme would encompass some of the indicative priority areas for submitting the proposals such as new ways of producing ASV like recombinant antibody based ASV production technologies; identification of herbal/peptide and small molecules for possible enhancement of available window for management; plant-made recombinant snakebite anti-venom antibody cocktail; and a pan-Asian anti-venom – with high potency anti-venom designed for several countries across the South Asian region, produced in large volumes and dispensed in a single dose. ]]> https://biospectrumindia.com/news/22/10009/j-p-nadda-launches-new-initiatives-on-universal-health-coverage-day-2017-.html https://biospectrumindia.com/news/22/10009/j-p-nadda-launches-new-initiatives-on-universal-health-coverage-day-2017-.html Mon, 11 Dec 2017 16:55:00 +0530 Universal Health Coverage Day, 2017 was observed in New Delhi today. We are committed to advancing the agenda of Universal Health Coverage in the country, and have rolled out various initiatives to meet this aim. This was stated by Shri J P Nadda, Union Minister of Health and Family Welfare at a function. The goal of achieving universal health coverage (UHC) has become the major focus of health system reform around the world. UHC is about ensuring that everyone has access to the health care they need without suffering financial hardship S.P. Shukla, MoS (Finance), Dr. Poonam Khetrapal Singh, Regional Director, SEARO; Dr. B D Athani, Special DGHS; Dr. V. K. Paul, Member, NITI Aayog;  Manoj Jhalani, AS&MD (NHM); Dr. Henk Bekedam, WHO Representative India and Vandana Gurnani, Joint Secretary along with the Health Secretaries and Mission Directors from the States were also present at the function. The Union Health Minister and MoS (Finance) launched “LaQshya| लक्ष्य’’ - Labour Room Quality Improvement Initiative which is a Safe Delivery Mobile Application for health workers who manage normal and complicated deliveries in the peripheral areas, and also released the Operational Guidelines for Obstetric High Dependency Units (HDUs) and Intensive Care Units (ICUs). There is enough evidence that supports the fact that improving the quality of care in Labour rooms especially on the day of birth, is central to maternal and neonatal survival. Recognizing this fact, Government of India is launching Laqshya- Labor Room Quality Improvement Initiative. LaQshya is expected to improve the quality of care that is being provided to the pregnant mother in the Labour Room and Maternity Operation Theatres, thereby preventing the undesirable adverse outcomes associated with childbirth. This initiative will be implemented in Government Medical Colleges (MCs) besides District Hospitals (DHs), and high delivery load Sub- District Hospitals (SDHs) and Community Health Centres (CHCs). The initiative plans to conduct quality certification of labour rooms and also incentivize facilities achieving the targets outlined. The goal of this initiative is to reduce preventable maternal and new-born mortality, morbidity and stillbirths associated with the care around delivery in Labour room and Maternity OT and ensure respectful maternity care. Addressing the participants, Nadda stated that, “This year is significant as the National Health Policy 2017 has been approved which envisages the attainment of the highest possible level of health without anyone having to face financial hardship as a consequence. The Government has taken concrete steps to reduce the Out Of Pocket Expenditure (OOPE).” “We are also focussed on increasing the basket of vaccines. Since 2014, we have launched Rotavirus vaccine, Pneumococcal Conjugate Vaccine (PCV), and the Measles-Rubella (MR) vaccine, and also the JE vaccine for adults, Shri Nadda elaborated. The Pradhan Mantri Dialysis Program has also been launched where 1.43 lakhs patients have availed free services from 1,069 Dialysis Units and under Free Drugs and Diagnostics Program; AMRIT outlets nearly 47 Lakh patients have benefitted from AMRIT Pharmacies through purchase of subsidized medicines.” He also informed the participants that to provide comprehensive primary care, the Government has announced transforming 1.5 lakh sub health centres to Health and Wellness centres. The Ministry is now moving towards provision of comprehensive primary care through the Health and Wellness Centres.” He further stated that in a step towards provision of comprehensive primary care, the Government has initiated universal screening of common NCDs such as diabetes, hypertension and common cancers at the sub-centre and Primary Health Centre. “This will enable the strengthening of preventive and promotive health, improve patient referral and access to secondary care services. The government has been at the forefront to strengthen the tertiary care and as such six new AIIMS are functioning and sixwill come up in due course”, he added. Reiterating the commitment of the Government towards Universal Health Coverage, S.P. Shukla stated that, “The Government is committed to providing the resources for achieving Universal Health coverage. He further said that the Government has increased the budget of the Health Ministry for 2017-18 by 27.7%. The Government has also through the 14th Finance Commission increased devolution from 32 % to 42% of divisible pool - an increase estimated at Rs. 25 lakh crore over award period to provide States with greater flexibility and autonomy to design, implement and finance schemes.”   ]]> https://biospectrumindia.com/news/22/10001/international-arogya-2017-concludes-with-the-call-to-promote-the-brand-of-ayush-world-over-.html https://biospectrumindia.com/news/22/10001/international-arogya-2017-concludes-with-the-call-to-promote-the-brand-of-ayush-world-over-.html Fri, 08 Dec 2017 17:25:00 +0530 The first international conference and exhibition on AYUSH and wellness systems organized by FICCI in collaboration with Ministry of AYUSH, Ministry of Commerce & Industry, and Pharmexcil, International Arogya 2017 concluded with participation of delegates from more than 70 countries and visitors from all over India. The four-day event was held in the backdrop of the National Health Policy 2017 strongly advocating mainstreaming the potential of AYUSH within a pluralistic system of Integrative healthcare. To further this cause different plenary sessions were conducted on issues such as business opportunities in Integrative Healthcare, building the brand AYUSH, global regulatory issues on AYUSH and matters related to standardization and regulation. The four-day global summit also witnessed a B2B meet on medicinal and aromatic plants. Speaking at the valedictory session Shripad Yesso Naik, Minister of State (Independent Charge), Ministry of AYUSH said: “During the past a few days we have deliberated upon the importance of AYUSH system. Harnessing its merit and immense potential for the wellbeing of mankind has been the focus of this gathering. We have witnessed the participation of more than 70 countries who have shown their willingness and resolve to work for the development of traditional medicine. The contemporary relevance of Ayush is ever increasing. AYUSH system not only makes scientific sense, but can also make considerable business impact. The enthusiastic participation of more than 250 traditional manufacturers itself shows that on the coming days this sector will emerge as a prominent economic entity resulting in enhanced transaction of Ayush products and its related services.” In the plenary session, Enhancing the Export Potential of AYUSH, Dr D C Katoch, Adviser, Ministry of AYUSH, who was the moderator of the session said: “AYSUH finished products export is worth USD 700 billion, and stand-alone potential of AYUSH raw material export from India is USD 3,000 million. There is a huge international market that needs to be exploited.” During the same session, Pramod Kumar Pathak, Joint Secretary, Ministry of AYUSH, announced that the Government of India has signed MoUs with 11 countries and established 28 AYUSH informative cells till now. Some of the key points put up during the plenary session, Business Opportunities in Integrative Healthcare, were the necessity of ‘trans-disciplinary approach’ to promote Integrative healthcare framework. In the plenary session, Standardization and Quality Control in AYUSH Sector, Roshan Jaggi, Joint Secretary, Ministry of AYUSH summed up by stating the emergence of AYUSH as a rising sector but reinforced the necessity that growth cannot be achieved without following the standards of international level besides State regulations. Standardization of AYUSH products is not an easy task due to its polyherbal and herbo-mineral nature but now is the time this issue needs to be addressed.                   ]]> https://biospectrumindia.com/news/22/10000/health-ministry-writes-to-finance-ministry-for-lowering-the-gst-on-medical-services.html https://biospectrumindia.com/news/22/10000/health-ministry-writes-to-finance-ministry-for-lowering-the-gst-on-medical-services.html Fri, 08 Dec 2017 16:40:00 +0530 The Union Health Ministry has written to the Finance Ministry seeking the reduction in GST rates for medical products and services either to five per cent or zero, informed sources said on Thursday. The letter was sent a couple of weeks ago after diagnostic centres and hospitals threatened to increase charges of services. Before the implementation of the Goods and Services Tax, the levy on maintenance of contract was 15 per cent, which was increased to 18 per cent. Similarly, for health insurance, the tax bracket was increased from 15 per cent to 18 per cent post-GST. For a hospital bed, it was increased from 11-16.5 per cent to 18 per cent and for oxygen from 12.5-15 per cent to 18 per cent. Pacemaker and heart valves are now under the 12 per cent bracket, up from five per cent. Sources said the Health Ministry also received a representation from the Association of Healthcare Providers. "The healthcare providers have basically said that they are in distress as all the services which had five per cent of tax have been increased to 12 and above under the GST," said the source. "They said that while they are not letting consumers get affected because of the taxation hike under GST, but if it is not lowered than they will increase it," source added. ]]> https://biospectrumindia.com/news/22/9994/lupin-cadila-start-drug-recalling-from-us-market.html https://biospectrumindia.com/news/22/9994/lupin-cadila-start-drug-recalling-from-us-market.html Fri, 08 Dec 2017 11:55:00 +0530 Drug firms Cadila Healthcare and Lupin have started recalling nearly 1.11 lakh units of Duloxetine delayedrelease capsules and 19,812 bottles of Paroxetine tablets, respectively, from the US market. According to the USFDA, 1,11,648 units of Duloxetine delayed-release capsules USP, in the strength of 30 mg, is being recalled by Lupin on account of failed dissolution specification. The drug was manufactured by Lupin Goa. The ongoing voluntary nationwide recall is a class III recall. Zydus Pharmaceuticals USA Inc, arm of Cadila Healthcare, is also recalling 19,812 bottles of Paroxetine tablets in the strength of 30 mg from the US market. The reason for the voluntary nationwide recall is the presence of foreign tablets or capsules, as Risperidone tablets were found in bottle of Paroxetine tablets. The product was manufactured by Cadila Healthcare. ]]> https://biospectrumindia.com/news/22/9985/health-minister-reviews-the-progress-of-intensified-mission-indradhanush-.html https://biospectrumindia.com/news/22/9985/health-minister-reviews-the-progress-of-intensified-mission-indradhanush-.html Thu, 07 Dec 2017 11:25:00 +0530 J P Nadda, Union Minister of Health and Family Welfare has reviewed the progress of Intensified Mission Indradhanush (IMI) with the Health Ministers and Principal Secretaries of 24 states. In the review meeting, he highlighted the state-specific issues and stressed upon the need for regular meetings of State Steering Committee and the Task Forces for strengthening inter-sectoral convergence. He stated, “We must replicate the good practices and also ensure that the gaps identified in the October and November rounds of Intensified Mission Indradhanush are addressed in the subsequent rounds to reach the target set by the Prime Minister.” He also suggested that Health Ministers of States and Principal Secretaries should organize video conferencing with the District Magistrates for reviewing IMI at regular intervals.  Preeti Sudan, Secretary (Health), Manoj Jhalani (AS&MD) and Vandana Gurnani, JS (RCH) along with other senior officers were present at the review meeting.  Nadda said that the Health Ministry will give the awards to the best performing districts and States based on the performance in Intensified Mission Indradhanush evaluated through the reported coverage and monitoring findings. The States and the Districts should achieve 90% full immunization coverage for getting rewarded.” Stressing that immunization is recognized as the most cost effective intervention for protecting children from vaccine-preventable diseases, the Health Minister said, “The gains made under Intensified Mission Indradhanush have to be integrated into routine immunization for sustainability. Together we need to ensure that no child in our country suffers from diseases prevented by vaccine.” To improve the coverage, Mission Indradhanush (MI) was launched with a strategy to focus on unvaccinated and partially vaccinated children in the pockets of low immunization coverage in high risk and hard-to reach areas identified through Polio micro-plans. More than 2.55 crore children and around 68.71 lakh pregnant women have been immunized during the four rounds of immunization spanning over two years divided into four phases, with each phase comprising of drives of 7 working days each for four consecutive months.  The progress has also been validated by the report of Integrated Childhood & Immunization Survey (INCHIS), according to which the first two phases of MI have led to an increase in full immunization coverage by 6.7%. Mission Indradhnaush is regularly reviewed by the Prime Minister. During one of the reviews, the Prime Minister showed urgency to reach out to each and every child with due vaccines and prepone the time line of 90% full immunization coverage by December 2018.A total of 190 districts/urban areas across 24 states have been identified for implementation of Intensified Mission Indradhanush which was launched by the Prime Minister on 8th October 2017 at Vadnagar, Gujarat.  IMI has completed two rounds during Oct’17 and Nov’17 except for Assam and Bihar where the sessions began in Nov’17 (due to floods in the preparation phase). IMI sessions will begin in Kerala from January’17 due to ongoing Measles-Rubella vaccination campaign.  After the two rounds of Intensified Mission Indradhanush (as on 4th December 2017),30.73 lakh children have been immunised, 8.03 lakh children have been fully immunized and 6.51 lakh pregnant women have been immunized.    ]]> https://biospectrumindia.com/news/22/9984/health-ministry-and-rotary-india-sign-mou-to-achieve-immunization-target.html https://biospectrumindia.com/news/22/9984/health-ministry-and-rotary-india-sign-mou-to-achieve-immunization-target.html Thu, 07 Dec 2017 11:10:00 +0530 A Memorandum of Understanding (MoU) has been signed between the Ministry of Health & Family Welfare (MoHFW) and Rotary India. The MoU signing ceremony was presided over by J P Nadda, Union Minister of Health and Family Welfare. This MoU was signed by Vandana Gurnani, JS (RCH) and Deepak Kapur, Chairman Rotary International India and will provide support and accelerate the efforts under Polio Eradication Programme, Routine Immunization including Mission Indradhanush, Intensified Mission Indradhanush.  The key areas for collaboration will be Social mobilization of beneficiaries, especially in urban slums and undeserved areas having no mobilizers; Support to the members of NCC, NYK, NSS etc. in their efforts of community mobilization through incentives like refreshments/mementoes during the sessions; Advocacy and generating awareness through innovative approaches and involving private practitioners and local leaders for Polio Eradication Programme, Routine Immunization including Mission Indradhanush, Intensified Mission Indradhanush and Measles-Rubella; The collaboration between Rotary International India National Polio Plus Committee in India and the Health Ministry will support the efforts of the states and the districts for advocacy and community mobilization for Polio Eradication Programme, Routine Immunization including Mission Indradhanush, Intensified Mission Indradhanush and Measles-Rubella and The event concluded by renewed commitment to reach out to the still unreached and most vulnerable children of the country.   ]]> https://biospectrumindia.com/news/22/9983/india-and-cuba-sign-mou-for-enhanced-cooperation-in-the-health-sector-.html https://biospectrumindia.com/news/22/9983/india-and-cuba-sign-mou-for-enhanced-cooperation-in-the-health-sector-.html Thu, 07 Dec 2017 10:55:00 +0530 India and Cuba signed a Memorandum of Understanding (MoU) for enhanced cooperation in the health sector. The MoU has been signed by J P Nadda, Union Minister of Health & Family Welfare and Dr Roberto Tomas Morales Ojeda, Public Health Minister of Cuba in the presence of senior officers from the Health Ministry and a high level delegation from Cuba. Terming it historic, J P Nadda stated that the relations between Cuba and India are historical and based on shared values of equality and justice, common aspirations and convergence of interests on global issues. He further stated that, “The MOU on cooperation in the field of health and medicine between India and Cuba is important for exchanges in the health sector and to develop institutional framework for cooperation in the health sector between the two countries. “One potential area is pharmaceutical and biotechnology. Cuba has made remarkable strides in the field of bio-technology and pharmaceuticals. We need to encourage greater institutional collaborations for joint production of medicines on commercial basis.” The objective of this MoU is to establish comprehensive inter-ministerial and inter-institutional cooperation between the two countries in the field of health by pooling technical, scientific, financial and human resources with the ultimate goal of upgrading the quality and reach of human, material and infrastructural resources involved in health care, medical education & training, and research in both countries. The main areas of cooperation include Exchange & training of medical doctors, officials, other health professionals and experts; Assistance in development of human resources, health services and setting up of health care facilities; Short term training of human resources in health; Regulation of pharmaceuticals, medical devices and exchange of information; Promotion of business development opportunities in pharmaceuticals and others identified by parties; Procurement of generic and essential drugs and assistance in sourcing of; drug supplies; Procurement of health equipment and pharmaceutical products; Any other area of cooperation as may be mutually decided upon; Procurement of health equipment and pharmaceutical products; Collaboration in the prevention of NCDs of mutual interest, such as neurocardiovascular diseases, cancer, COPDs, mental health and dementia, with an emphasis on SDG3 and related factors; Collaboration in the field of climate change impact on communicable diseases and vector borne diseases; Nutritional aspects of food intake, including malnutrition (over-nutrition and under-nutrition) in the light of the SDG2 and organization of nutritional services; Safety of production, transformation, distribution and food delivery; Research and training of food industry operators; Information and communication to citizens on hygiene and food safety and healthy eating habits and Any other area of cooperation as may be mutually decided upon.   ]]> https://biospectrumindia.com/news/22/9975/fda-releases-new-guidelines-for-3d-printing-devices.html https://biospectrumindia.com/news/22/9975/fda-releases-new-guidelines-for-3d-printing-devices.html Wed, 06 Dec 2017 11:30:00 +0530 The U.S. Food and Drug Administration (FDA) has issued new guidelines related to the 3D printing of medical devices. FDA is now preparing for a significant wave of new technologies that are nearly certain to transform medical practice. 3D printing of medical devices, medications and human tissue is quickly becoming a promising reality. Patients have already benefitted from 3D printed medical products through access to personalized devices and innovative drugs that have led to significant health improvements. The new guidelines include information on how to properly submit devices to the FDA, device design, how to test for function and durability and much more. The Center for Biologics Evaluation and Research has recently interacted with more than a half-dozen manufacturers who have expressed interest in using 3D printing in some capacity to produce their medical products. Developing a transparent policy on 3D printing remains an important next step, and FDA plans to explore the role of nontraditional manufacturing facilities like a hospital operating room or university laboratory. The FDA also plans to review the regulatory issues related to the bioprinting of biological, cellular and tissue-based products in order to determine whether additional guidance is needed beyond the recently released regulatory framework on regenerative medicine medical products. ]]> https://biospectrumindia.com/news/22/9973/anupriya-patel-inaugurates-22nd-ahwp-conference-.html https://biospectrumindia.com/news/22/9973/anupriya-patel-inaugurates-22nd-ahwp-conference-.html Tue, 05 Dec 2017 22:10:00 +0530 Anupriya Patel, MoS (Health & Family Welfare) recently inaugurated the 22nd conference of Asian Harmonization Working Party (AHWP) at New Delhi. The five day conference is being conducted by Central Drugs Standard Control Organization (CDSCO) and National Drug Regulatory Authority (NDRA) of India in collaboration with Ministry of Health & Family Welfare. The key objective of the event is to develop and recommend approaches for the convergence and harmonization of medical device regulations in Asia and beyond and to facilitate the exchange of knowledge and expertise amongst regulators and the industry. The inaugural function was also attended by Preeti Sudan, Secretary (HFW), Dr. R K Vats, Additional Secretary (Health) along with the other senior officers of the Ministry, CDSCO, NDRA, dignitaries from other countries and representatives of the development partners. Asian Harmonization Working Party (AHWP) was established in 1999 as a voluntary non-profit organization of the 30 national regulators of member countries and industry members with a goal to promote regulatory harmonization on medical device regulations in Asia and other regions in accordance with the guidance issued by International Medical Device Regulators Forums (IMDRF). The AHWP works in collaboration with related international organizations such as IMDRF, WHO, International Organization for Standardization (ISO), etc. The Health Ministry has recently come out with the regulation i.e. Medical Devices Rules, 2017, for better harmonization with global regulatory practices and to have transparent, predictable and robust regulatory system which will further ensure safety, quality and performance of medical devices and In vitro diagnostics being manufactured in the country. Additionally, the Government has already allowed 100% FDI in the medical devices sector to promote Make in India.  The Government intends that with such efforts, affordable medical devices to the best of the quality standards, is made available to the citizens across the vast and diverse geographical locations.   ]]> https://biospectrumindia.com/news/22/9962/j-p-nadda-reviews-the-preparedness-on-seasonal-influenza-h1n1-.html https://biospectrumindia.com/news/22/9962/j-p-nadda-reviews-the-preparedness-on-seasonal-influenza-h1n1-.html Tue, 05 Dec 2017 12:45:00 +0530 Necessary directions to monitor seasonal influenza cases with particular focus on creating awareness, ensuring availability of medicines and vaccines at field level and effective and early treatment of patients as per protocol was recently issued by J P Nadda, Union Minister of Health and Family Welfare. A high level meeting was recently held in Delhi which was chaired by J P Nadda. He reviewed the preparedness for prevention and management of seasonal Influenza (H1N1). Preeti Sudan, Secretary (Health) and senior officers from the Ministry, NCDC, DGHS and ICMR were also present.  During the review meeting, it was brought out that advisories have already been issued during the year to the States and the situation is being weekly monitored by the Union Health Ministry. The Ministry has also undertaken adequate steps to augment capacity of health facilities, to manage cases of Influenza (H1N1) and have further strengthened its testing facilities. The Ministry has also ensured availability of PPE Kits and N-95 Masks for healthcare workers dealing with the cases. It was observed that there are sufficient tablets of Oseltamivir for early treatment of Influenza (H1N1) cases.  Considering the seasonality of the disease, Nadda has directed the officials to ensure continuous monitoring and vigil on all cases of Swine Flu. He specifically instructed that early detection, reporting and proper categorization of patients is critical for Swine Flu management. Accordingly, the Minister has instructed National Centre for Disease Control (NCDC) to monitor the cases on a daily basis. He suggested that States shall ensure that proper awareness is created on the disease with particular focus on interior and rural areas. All States shall also ensure that sufficient supplies of Oseltamivir drug are maintained at State level. The drug has been now kept under schedule H1 of Drugs and Cosmetics Act and hence States shall ensure its wider availability with private Pharmacies also. He further directed that "Necessary action be initiated to increase number of testing facilities for Swine Flu case both in Government and Private Sector and NCDC shall provide required support to the States on the issue. Further, all cases which require hospitalization shall be monitored intensively both at district and State level so as to ensure that fatalities can be avoided. Availability of sufficient functional ventilators for critical case management is important and States shall be advised accordingly. NCDC shall coordinate with States to provide ventilator support training, if need be." The Union Minister directed the Central government institutions to also earmark sufficient number of beds for seasonal influenza A (H1N1) patients. ]]> https://biospectrumindia.com/news/22/9955/ima-urges-finance-ministry-to-reduce-gst-on-medical-devices-drugs-to-5-from-12.html https://biospectrumindia.com/news/22/9955/ima-urges-finance-ministry-to-reduce-gst-on-medical-devices-drugs-to-5-from-12.html Mon, 04 Dec 2017 17:15:00 +0530 The Indian Medical Association (IMA) has urged the Union finance ministry to reduce the goods and services tax (GST) on all medical equipments, devices, medicines and consumables to 5 per cent  from the present 12 per cent to make healthcare affordable for all. With disposables, drugs and reagents being bracketed under 12 per cent GST, the cost of surgeries and other procedures (that involve use of disposables and reagents) has gone up considerably. The old tax rate for these items varied between 2 per cent to 5.5 per cent, said IMA national president Dr KK Aggarwal. The services which face increased taxation due to GST are dialysis (5% to 12%), pacemaker (5.5% to 12-18%), support devices in orthopedics (5% to 12%) and all support devices for cancers except blood cancer (5% to 7-12%). Ancillary medical procedures and diagnostics, which play a key role in treatment, have been put under the 12% and 18% slab respectively. GST should be altered for diagnostic (viral transport media and culture media) from 18% to 12% as is applicable for all other diagnostic kits and reagents, said Dr Aggarwal. Most of the medical devices and implants which were importable at 0% duty, consequent to the imposition of GST, the 5% VAT has gone up to 12% IGST. The items covered in this are medical devices, cardiac implant and other high-end items like pacemakers, LVAD, etc.  The ministry should intervene and reduce GST on all medical equipments, devices, medicines and consumables to 5% as against 12%.  If the government takes definition of life saving as per Income Tax Act, very few devices will be included. Consumables can be equated with surgical items which at present attract 5% GST, he added. The effective tax on input services has gone up from 15% to 18%. This obviously will now lead to inflation in cost of healthcare services and impact the viability of the sector, since most of the services like housekeeping, GDA, security, food and beverage and repair & maintenance are typically outsourced in the hospital. The IMA appealed to finance ministry to allow exemption from input GST for some of the services namely GDA, housekeeping, F&B and repair & maintenance. Hospitals were issued scrips under Served From India Scheme (SFIS) earlier. These scrips were usable for the payment of various duties/taxes to Central government on importation including countervailing duty (CVD) etc. Now the scrips can be used only to pay custom duty, which makes the whole equation uneconomical and the very purpose of scrip is defeated. We request the ministry to allow for the payment of IGST against the scrips, said IMA national president. Landed cost of imported equipment has significantly gone up with the implementation of IGST. Since earlier the imports did not have VAT on all the following equipment, the landed cost of equipments which were not manufactured in India has now come under IGST regime which in turn increased the landed cost from 8% to 10%. The ministry should review the situation especially with regard to medical equipments which are not manufactured in India so that the investments in technology are optimized. The IMA urged the ministry to do away with provision of reverse charge applicable to healthcare. The purpose of reverse charges was to pay GST and take credit. For healthcare, where the end services are exempt – this is added costs and efforts, said Dr Aggarwal. The doctors’ representative body has also appealed to the ministry to decrease GST on health insurance premium to 5 % from 18%. In direct taxes (Income tax) there is an exemption under Section 80D on payment for health insurance. But in Indirect taxes there is a GST tax of 18% on payment for health insurance, he said. ]]> https://biospectrumindia.com/news/22/9932/india-has-reduced-its-new-malaria-cases-by-one-third-health-minister.html https://biospectrumindia.com/news/22/9932/india-has-reduced-its-new-malaria-cases-by-one-third-health-minister.html Thu, 30 Nov 2017 15:30:00 +0530 High Level Roundtable on “Accelerating the Elimination of Malaria in the South-East Asia Region” was recently held in New Delhi. Also present ate the event were Asia Pacific Leaders Alliance against Malaria, representatives from the Asian Development Bank, the Global Fund to Fight AIDS, TB and Malaria, members of the Strategy Advisory Group for Malaria Elimination and various development partners, health Ministers from the countries of South Asia Region, Heads of Country Delegations, Dr. Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region and Dr. Soumya Swaminathan, WHO, Deputy Director General Designate also graced the occasion. At the function, J P Nadda also launched the book “Addressing the challenge of controlling malaria across international border lines” and unveiled the Regional Action Plan (2017-2030).  The three-day ministerial roundtable on accelerating elimination of malaria in the South-East Asia region is in consonance with the United Nations Assembly Resolution on consolidation and accelerating efforts to control and eliminate malaria.  Speaking at the occasion J P Nadda said, “India has reduced its new malaria cases by one third, and even crossed the malaria mortality targets of 2020. With nearly ¾ of the share of the regional burden, India’s successes have significantly contributed to the reduction of the burden of malaria for the entire South-East Asia region.  “This success comes against the backdrop of the political leadership and support that health programs have received in India. The commitment to ensure health for every person in India comes from the highest office of the Government. It is Prime Minister Shri Narendra Modi ji’s vision to see health and development reach to the furthest corners of our country, and use the very latest innovations in technology and implementation science to achieve these outcomes,” the Union Health Minister elaborated”, he added. Nadda stated that that the majority of malaria cases in the country come from the bordering districts, forest and tribal areas, while most of the remaining parts of the country remain malaria free. “Addressing malaria therefore, is not only an issue for India’s aspiration of achieving universal health coverage, but also achieve it with equity. Reiterating the commitment to eliminate Malaria, health minister stated that the focus on the bordering districts and empowering local authorities with information, tools and knowledge will help malaria reductions in India and its neighbours. India as a hub for research and science would also support malaria implementation research, as well as capacity building in health research.  ]]> https://biospectrumindia.com/news/22/9931/india-signs-mou-with-italy-for-enhanced-cooperation-in-the-health-sector.html https://biospectrumindia.com/news/22/9931/india-signs-mou-with-italy-for-enhanced-cooperation-in-the-health-sector.html Thu, 30 Nov 2017 15:20:00 +0530 India and Italy has signed a Memorandum of Understanding (MoU) for enhanced cooperation in the health sector. J P Nadda, Union Minister of Health & Family Welfare and Beatrice Lorenzin, Health Minister of Italy signed the MoU in the presence of senior officers from the Health Ministry and a high level delegation from Italy. J P Nadda stated that both the countries share a strong and rich traditional relationship which has been enhanced by high level visits. Also, there is a mutual interest in the promotion of stronger ties in the health sector. The MoU recognizes the potential for exchanges in the health sector between the two countries and the need to tap the capabilities and opportunities in a focused and comprehensive manner. The objective of this MoU is to establish comprehensive inter-ministerial and inter-institutional cooperation between the two countries in the field of health by pooling technical, scientific, financial and human resources with the ultimate goal of upgrading the quality and reach of human, material and infrastructural resources involved in health care, medical education & training, and research in both countries. The main areas of cooperation will include Exchange & training of medical doctors, officials, other health professionals and experts; assistance in development of human resources and setting up of health care facilities; short term training of human resources in health; regulation of pharmaceuticals, medical devices and cosmetics and exchange of information thereon; promotion of business development opportunities in pharmaceuticals; procurement of generic and essential drugs and assistance in sourcing of drug supplies; procurement of health equipment and pharmaceutical products; collaboration in the prevention of NCDs of mutual interest, such as neurocardiovascular diseases, cancer, COPDs, mental health and dementia, with an emphasis on SDG3 and related factors; collaboration in the field of climate change impact on communicable diseases and vector borne diseases; nutritional aspects of food intake, including malnutrition (over-nutrition and under-nutrition) in the light of the SDG2 and organization of nutritional service; safety of production, transformation, distribution and food delivery; research and training of food industry operators.   ]]> https://biospectrumindia.com/news/22/9917/health-ministry-launch-india-hypertension-management-initiative-with-icmr-.html https://biospectrumindia.com/news/22/9917/health-ministry-launch-india-hypertension-management-initiative-with-icmr-.html Wed, 29 Nov 2017 11:55:00 +0530 Preeti Sudan, Secretary, Ministry of Health & Family Welfare and Dr. Soumya Swaminathan, Secretary, DHR and DG, ICMR has launched the India Hypertension Management Initiative (IHMI) recently in New Delhi. Reducing the disability and death related to cardiovascular disease (CVD by improving the control of high blood pressure (hypertension), reducing salt consumption and eliminating artificial trans-fats, leading risk factors for CVD is the main aim of IHMI. Also present at the event were Manoj Jhalani (AS&MD, NHM), Dr BD Athani (Special DGHS) and Pawan Aggarwal, CEO, FSSAI and Dr Alka Aggarwal Singh, Country Director, Vital Strategies along with the other senior officers of the Ministry and representatives of international development organizations.  The India Hypertension Management Initiative (IHMI) is a collaborative project of Indian Council of Medical Research (ICMR), Ministry of Health and Family Welfare (MoHFW), State Governments, World Health Organization (WHO), and Resolve to Save Lives initiative of Vital Strategies. The primary goal of this project is to reduce morbidity and mortality due to CVDs, the leading cause of death in India, by improving the control of high blood pressure, which is a leading risk factor for CVDs among adults in India.  The IHMI is focused on five essential components of scalable treatment of hypertension. It will support the adoption of standardized simplified treatment plans for managing high blood pressure, ensure the regular and uninterrupted supply of quality-assured medications, task sharing so health workers who are accessible to patients can distribute medications already prescribed by the medical officer, and patient-centered services that reduce the barriers to treatment adherence. Data on hypertension will be improved through streamlined monitoring systems, and the lessons learned and practice-based evidence will inform further interventions to improve cardiovascular care. IHMI will be progressively rolled out in 25 districts in the first two years across districts selected by the Health Ministry for expansion of active screening and intensification of treatment activities for hypertension.  Preeti Sudan underlined the various aspects of the non-communicable diseases like prevention, detection and management. She stated, “Creating awareness about NCDs is vital as it is a silent disease. There is urgent need to raise awareness about NCDs amongst families regarding packaged food and processed foods with excessive salt and trans-fat.” She also highlighted the need for incorporating yoga in one’s life for prevention and management of hypertension.  Dr. Soumya Swaminathan highlighted the importance of initiating and managing treatment for hypertension. She emphasized on the need for public education programme on nutrition and training of frontline healthcare workers regarding management of hypertension. She stated, “The risk factors have to be managed at a very young age and we need to look into behavioral issues related to food intake, especially salt.” Dr Henk Bekedam, WHO India Representative, highlighted the importance of awareness and detection of hypertension. He congratulated the Health Ministry and ICMR for this initiative and said that this programme will help with the management of hypertension in the country.  ]]> https://biospectrumindia.com/news/22/9916/president-addresses-the-scientific-community-of-kolkata.html https://biospectrumindia.com/news/22/9916/president-addresses-the-scientific-community-of-kolkata.html Wed, 29 Nov 2017 11:45:00 +0530 Ram Nath Kovind, The President of India recently addressed the scientific community of Kolkata at a Vigyan Chintan event organised at Raj Bhavan, Kolkata. Speaking on the occasion, the President said that in its essence, science is about human fascination and curiosity. It is about that endless quest for new frontiers. For thousands of years, from the age of Aryabhatta and Charaka, India has embraced science and its sense of inquiry. Science has been our intellectual trigger as well as our force multiplier. In modern times Kolkata and Bengal have been central to this process. Today the challenge is to widen that culture to other geographies, both within the state and outside. As well as to deepen that culture by incubating a society that understands, encourages and embraces innovation – down from our leading scientific institutions to our schools and our educational system.  “There is truly something special about Bengal. Pointing out the fact that IISc, Bengaluru was started after Swami Vivekandnda’s request to Jamsetji Tata set up a world-class science research institution in our country, he stated that on this soil even a Swami devoted to spiritualism can have a sensitive appreciation for – and a fascination for – modern science.” The President said that to this day, young students from Bengal, young science graduates and scientists, young engineers and technologists, contribute so much to the furthering of science and of knowledge. They do so all over the country and all over the world. It is important to harness that scientific talent pool in Bengal for the good of Bengal itself. And to once more convert Kolkata into the tech hub of India that it was a century ago, or even 50 years ago.  The President appreciated the commitment of scientists to the nation. He said that they are true nation builders and have a major responsibility for the realisation of New India – an India that will achieve certain developmental milestones by 2022. New India cannot be achieved without New Bengal. And neither New India nor New Bengal can be achieved without the scientific community here contributing in strong measure.  ]]> https://biospectrumindia.com/news/22/9906/icmr-demands-clinical-trials-outcomes.html https://biospectrumindia.com/news/22/9906/icmr-demands-clinical-trials-outcomes.html Tue, 28 Nov 2017 11:10:00 +0530 The Indian Council of Medical Research (ICMR) is making it mandatory for all clinical trials to report results back to them, regardless of whether they are published in peer reviewed journals or not. The Clinical Trials Registry of India (CTRI) is run by ICMR, where investigators have to mandatorily register trials but it is only recently that the council realised that it has no information on trial outcomes. ICMR stated that a lot of times when the results are negative, especially for trials that are funded by pharmaceutical companies, the data is never made public. According to the new decision, the investigators will have to within a year of completion of a trial come back and inform the registry about the outcome. This will be implemented from April 2018. The CTRI, which does not have the mandate to take action against errant investigators, will instead blacklist those that do not comply. There is no data on what percentage of Indian trials get published but internationally only 50-60% trials make it to the pages of peer reviewed journals. The number of trials registered with CTRI has risen steadily from 545 in 2009 to 1,327 in 2017. The CTRI has 8,950 trials registered as on June 30, 2017, of which 2,036 have been completed and 28 terminated. ]]> https://biospectrumindia.com/news/22/9903/need-to-promote-cadaver-or-deceased-organ-donation-anupriya-patel-.html https://biospectrumindia.com/news/22/9903/need-to-promote-cadaver-or-deceased-organ-donation-anupriya-patel-.html Mon, 27 Nov 2017 20:30:00 +0530 Anupriya Patel, Minister of State (HFW) recently inaugurated ‘8th Indian Organ Donation Day’, organised by the National Organ and Tissue Transplant Organization (NOTTO) She stated, “When seen from the perspective of reason and rationale, the gift of life is the ultimate gift that one could give and organ donation is, therefore, a ‘God like act’ and needs to be encouraged.” Dr. C. Vijaya Baskar, Minister of Health, Government of Tamil Nadu was also present at the function,  Dr. Jagdish Prasad, Director General Health Services, Dr. R.K. Vats, Addl. Secretary, Health, Dr Sudhir Kumar, Joint Secretary, MoHFW; K. K. Sharma, Director General BSF; Dr. Vimal Bhandari, Director, NOTTO and senior officers from BSF, CRPF and the students and representatives of various development organizations were also present. Urging all to come forward and donate their organs, she said that apart from promoting organ donation, it is important to improve infrastructure and capacity of Government Hospitals for undertaking transplantation so that even those who cannot afford transplantation may also benefit. She also administered the pledge to the participants to donate organs. Minister also stated that it is important to understand that in India it is mainly the living donors who are donating organs and only about 23% of the organ transplant is being done with organs obtained from the cadavers. There is a need to promote cadaver or deceased organ donation rather than relying on living donors in order to avoid the risk of commercial trading of organs and also to avoid the inherent risk to the health of the living donor. Dr. C. Vijaya Baskar, Minister of Health, Government of Tamil Nadu said, “happiness at the announcement of Tamil Nadu being adjudged the Best State in Organ Donation for the third time in a row.” He highlighted the exemplary work that Tamil Nadu had done by retrieving 5933 organs from 1056 donors; and had been the first state in India for various initiatives like mandatory certification of Brain Stem Death, streamlining organ distribution and setting up green corridors. He informed the participants that Tamil Nadu is also supplying free immunosuppressant drugs and is providing sanctions of upto Rs. 35 Lakh under the Chief Minister Comprehensive Health Insurance Scheme for facilitating organ transplants in the private sector.  Preeti Sudan, Secretary (Health) urged the religious leaders and youth to take forward the movement of organ donation and highlighted the importance of ownership at the highest level, and connectivity at the lowest level to build up a successful and transparent organ donation program in the country. The best performing states of Tamil Nadu, Maharashtra and Telangana also received awards whereas JIPMER, Puducherry was announced as the Best Budding performer in Organ Donation and Transplantation. Yashoda Hospital, Telangana, PGI, Chandigarh and Sahidri Speciality Hospital, Pune were declared as the top three Best Hospitals in the country for their contribution. Dr. Patricia Namitha Maria Viego and Dr. P. Periyanayagam, Tamil Nadu who are the transplant co-ordinators, Karnataka along with Sangeeta Sherawat from Safdarjung Hospital and Balram from AIIMS bagged the prizes for best transplant co-ordinators. Non-government organisations like the Mohan Foundation, Organ India, NSS, and Kidney Foundation of India were also felicitated for their efforts.  ]]> https://biospectrumindia.com/news/22/9888/centre-amended-the-drugs-and-cosmetics-rules-1945-to-allow-sale-of-homeopathic-drugs-otc.html https://biospectrumindia.com/news/22/9888/centre-amended-the-drugs-and-cosmetics-rules-1945-to-allow-sale-of-homeopathic-drugs-otc.html Sat, 25 Nov 2017 15:10:00 +0530 On the recommendation of the Drugs Technical Advisory Board (DTAB), the Union Ministry of Health and Family Welfare has amended the Drugs and Cosmetics Rules, 1945. The DTAB had urged the government to strictly regulate sale of homeopathic medicines and take efforts to increase the availability of these drugs to needy patients. According to the amended rules, the allopathic chemist shops are allowed to sell only over the counter (OTC) homeopathic products. Now, homeopathic medicines can be purchased over the counter (OTC) from the common chemist shop selling allopathic drugs. Under the existing laws, the sale of homeopathy and allopathic drugs from the same shop was not allowed. The new rules restrict loose sale of homeopathic medicines and mandates shops to sell only full bottle-sealed medications or dilutions. However, consultation of patients is not allowed from any of these pharmacies. Doctors, who dispense homeopathic drugs from their clinics, can continue to do so. The amendment has also brought in stipulated qualifications for those who dispense homeopathic drugs. Now, homeopathic pharmacists should have a diploma in pharmacy or a diploma in homeopathy and surgery or diploma in homeopathic pharmacy or be a science graduate with minimum one year experience of dealing in homeopathic drugs. Dr M Arulvanan, secretary general of the Indian Homeopathic Medical Association (IHMA) said, “The amendments did not restrict homeopathic doctors from practising in their premises from dispensing medicines to their own patients. This amendment restricts only those doctors practicing in homeopathy pharmacy premises from selling medicines.” ]]> https://biospectrumindia.com/news/22/9887/ambuja-cement-foundation-to-strengthen-ncds-focus-across-rural-india.html https://biospectrumindia.com/news/22/9887/ambuja-cement-foundation-to-strengthen-ncds-focus-across-rural-india.html Sat, 25 Nov 2017 14:45:00 +0530 With the aim of creating prosperous rural communities, Ambuja Cement Foundation (ACF) organized a participatory dialogue –Multi Stakeholder Consultation on Non-Communicable Diseases recently in New Delhi which saw participation from various industry experts and other stakeholders who were involved either directly or indirectly in the public health space. Established in 1993, ACF is the social development arm of Ambuja Cements Ltd. exclusively working with rural communities to make them self-reliant and help them utilize their potential for a prosperous life. The foundation elaborated its holistic efforts to significantly expand its Non-Communicable Disease intervention program outreach in the coming years while stressing on stronger stakeholder partnerships to develop a robust health care system. ACF’s ongoing intervention program through its effective partnership models covers nearly one lakh people across 101 villages in four locations in India. On this occasion, Pearl Tiwari, head,  Ambuja Cement Foundation said, “Changing lifestyles combined with lack of awareness has led to the rising epidemic of Non-Communicable Diseases in rural locations across the country. While rural women suffer from malnourishment, youth have been falling prey to substance abuse of tobacco and alcohol – further aggravating their risk of developing NCDs. The situation is critical and demands urgent intervention from various stakeholders to partner and develop a cohesive and sustainable healthcare awareness campaign that addresses the issue at grassroots.” “Non-Communicable Diseases account for nearly 60% of deaths in India at present. Mitigation of NCDs needs constant and concentrated efforts at multiple levels which can be made possible only through synergetic efforts by all stakeholders. ACF shall continue its endeavour to build healthy communities to enable people to lead more fruitful and productive live,” she added. ACF aims to log at least two-fold expansion of its outreach by focusing more in developing and strengthening community-based organisations and villages committees such as village development committee, village health and nutrition committee which will emphasise on behavioral change for sustainable impact. The teams will also collaborate with government agencies and philanthropic organizations, proactively participate in the National Programme for prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) efforts while developing skills, capacities and capabilities among frontline workers and health professional to create linkages and access of affordable treatment for the needy.       ]]> https://biospectrumindia.com/news/22/9885/nppa-is-capping-prices-of-essential-formulations.html https://biospectrumindia.com/news/22/9885/nppa-is-capping-prices-of-essential-formulations.html Fri, 24 Nov 2017 15:55:00 +0530 The National drug pricing regulator (NPPA) has capped prices of 51 essential formulations, including those used for the treatment of cancer, pain, heart conditions and skin problems. The prices have been slashed in the range of 6 to 53 per cent. Prices have been capped for colon or rectal cancer treatment drug oxaliplatin (injection 100mg), Japanese encephalitis vaccine and measles rubbela vaccine. Ceiling prices of drugs including anaesthetic sevoflurane, Phytomenadione (Vitamin K1) and tuberculosis prevention medicine BCG vaccine have been revised. In separate notifications, the drug price regulator has notified ceiling prices of 13 formulations, while revising the same for 15 formulations. Retail prices of 23 essential formulations have also been notified. In respect of medicines that are not under price control, manufacturers are allowed to increase the maximum retail price by 10 per cent annually. ]]> https://biospectrumindia.com/news/22/9870/centre-reduces-national-health-mission-funding.html https://biospectrumindia.com/news/22/9870/centre-reduces-national-health-mission-funding.html Thu, 23 Nov 2017 11:20:00 +0530 The flagship health programme of the government has received approval almost 20 percent lower than what the health ministry said was needed. The National Health Mission was renewed by the Finance Ministry in August with $20 billion of funding between 2017- 2020. This figure was against the health ministry's estimated requirement of $25 billion. It was stated that the finance ministry reduced planned funding because of other spending priorities and because of state governments' poor track record of spending the health budgets they've been allotted in the past. The National Health Mission forms the backbone of the Indian public services and is one of the world's largest health programmes. It provides everything from free drugs to immunisation services to millions of rural poor. The National Health Mission typically accounts for about half of the Union health budget and officials said the lower spending approval would make achieving the government's 2025 target more difficult. The government is also concerned about states that do not have the governance capacity to spend large health budgets efficiently. A shortage of workers, bureaucratic bungling and slow procurement processes have plagued the states' health systems. Previously, the health officials faced criticism from other government departments for the National Health Mission's inefficiencies and were asked to rework the renewal proposal for 2017-20 after they drew up spending estimates of $33 billion. ]]> https://biospectrumindia.com/news/22/9859/j-p-nadda-inaugurates-1st-world-conference-on-access-to-medical-products-international-laws-for-trade-and-health-.html https://biospectrumindia.com/news/22/9859/j-p-nadda-inaugurates-1st-world-conference-on-access-to-medical-products-international-laws-for-trade-and-health-.html Tue, 21 Nov 2017 16:25:00 +0530 J P Nadda, Union Minister of Health and Family Welfare today inaugurated the ‘1st World Conference on Access to Medical Products and International Laws for Trade and Health in the Context of the 2030 Agenda for Sustainable Development’ While inaugurating the conference he said, “India is deeply committed nationally and globally to achieving all public health goals and also focusing on developing India as a hub for affordable medical devices. There is a need for promoting industry and academia collaboration for developing affordable medical products such that innovations and advances in medical sector reach a vast population.” The Conference is being organized by the Ministry of Health & Family Welfare with the support of WHO Country Office for India and in partnership with Indian Society of International Law. The objective of the Conference is to exchange knowledge and expand understanding on contemporary issues in international trade laws and research and innovation for access to medical products to achieve SDG 2030 agenda.  Anupriya Patel, Minister of State (HFW), Dr. V.K. Paul, Member, NITI Aayog, Preeti Sudan, Secretary (Health), Dr. Soumya Swaminathan, Secretary, Dept. of Health & Research (DHR) and DG, ICMR; Dr. Jagdish Prasad, Director General Health Services; Dr. R.K. Vats, Addl. Secretary, Ministry of Health & Family Welfare; Dr. Henk Bekedam, WHO Representative to India; and Dr. EMS Natchiappan, President, Indian Society of International Law, India along with other senior officers of the Ministry, delegates from various countries and representatives of development organisations were also present. Health Minister also stated, “The coordination between the National Regulatory Authorities and pharmaceutical sector will enable launch and registration of new health technologies. He further said that the dialogue on role of competition in competitive pricing and discussion on related WTO agreements influencing health should lead to a larger umbrella of suggested policy options for the government.” “2015 National Medical Device Policy will enable local manufacture in the multiproduct, multidisciplinary industry. In India, nearly 150 thousand orthopaedic knee procedures are done every day. More investments and more players in the medical devices sector will lead to lowering down of prices and access to medical products as most of the governments are sensitive to access and pricing of medical products,” he added.  Addressing the conference via video link, Ashwini Kumar Choubey, Minister of State (HFW) said, “Research and development in public health should focus on two main aspects. To enable safe, effective and quality medical products for the diseases and rolling out the innovations and inventions along with the learning’s from the field to the people.” “The research and development should focus on making the cost of medical devices/products affordable to the people and highlighted the issue of Anti-microbial Resistance (AMR)”, he added. Speaking at the function, Anupriya Patel, Minister of State (HFW), stated, “India is committed to attainment of the highest possible standards of health for its citizens. She further said that at the national level, access to medical products (medicines, vaccines, medical devices & diagnostics) is an important facet in the health system as a whole and at the international level, access to medical products is a critical factor for the success of the 2030 sustainable development goals agenda that aims to ensure healthy lives and to promote well-being of people of all ages.” Dr. V.K. Paul, Member, NITI Aayog stated, “There is a need for investment in medical products for preventive therapy and treatment and highlighted the importance of affordability, quality, domestic production capacity and to create an eco-system of policy and innovation for greater accessibility of affordable medical drugs and devices. Technology is an integral block for strengthening medical systems in any country and must also ensure timely maintenance of medical equipment by suppliers in remote and rural areas such that equipment functions effectively.”  Preeti Sudan, Secretary (Health) spoke about the issues of access of medicines and medical products. She said that safe medical products should be available at affordable prices. She further reiterated that the Health Ministry is committed to robust regulatory systems for ensuring safety, quality and efficacy of drugs.  Dr. Soumya Swaminathan, Secretary (DHR) and DG, ICMR highlighted issues such as how to use TRIPs flexibilities; alternative models for affordable medicines and devices such as voluntary licensing; clear predictable regulatory pathways; more investment in R&D and publicly funded R&D; innovative healthcare service delivery models; anti-biotic stewardship; and collaboration between the public and private sectors including academia to reduce cost of production and delivery.  ]]> https://biospectrumindia.com/news/22/9858/ayush-to-review-draft-of-national-policy-of-maps-of-india-to-be-held-tomorrow-.html https://biospectrumindia.com/news/22/9858/ayush-to-review-draft-of-national-policy-of-maps-of-india-to-be-held-tomorrow-.html Tue, 21 Nov 2017 15:50:00 +0530 Ministry of AYUSH is organising a day long review meeting on “Draft of National Policy of Medicinal and Aromatic Plants (MAPs) of India” tomorrow at Pusa Campus, New Delhi. Sripad Yesso Naik, the Minister of State (Independent Charge) for AYUSH will address the inaugural session of this meeting. To improve and finalize the proposed draft Policy Document, National Medicinal Plant Board along with Federation of Medicinal and Aromatic Plants Stakeholders are jointly organizing the one day review meeting. Vaidya Rajesh Kotecha, Secretary, Ministry of AYUSH; Shomita Biswas CEO, National Medicinal Plants Board; Pankaj Asthana, IGF, Ministry of Environment, Forest and Climate Change; Alka Bhargava, Joint Secretary, Ministry of Agriculture and Farmers Welfare;  Rajiv Kumar, Joint Secretary, Ministry of Electronics and Information Technology will also be present on this occasion. This will be followed by 8 brainstorming sessions of more than 35 panellists on various topics. The important areas of Medicinal Plants Sector like Forest & Conservation, Infrastructure, Marketing & Trade, Cultivation, Sustainable Harvesting & Post harvest Management, Quality & Certification, Research & Development, Regulatory & Legal framework, Networking & IT/Space Intervention, Finance and Information, Education & Communication and Capacity Building are proposed to be covered in the 8 sessions by specialists from all over the country. During the Inaugural session, NMPB will also launch the “Voluntary Certification Scheme of Medicinal Plants Produce (VCSMPP)”, designed by NMPB through Quality Councils of India (QCI).   ]]> https://biospectrumindia.com/news/22/9855/the-russian-federation-host-first-ministerial-conference-to-end-tb.html https://biospectrumindia.com/news/22/9855/the-russian-federation-host-first-ministerial-conference-to-end-tb.html Tue, 21 Nov 2017 12:10:00 +0530 First WHO Global Ministerial Conference on Ending Tuberculosis in the Sustainable Development Era: A Multisectoral Response was recently held in Moscow where 75 ministers agreed to take urgent action to end TB by 2030. Vladimir Putin, President of the Russian Federation opened the Conference, together with Amina J Mohammed, UN Deputy Secretary General, and Dr Tedros Adhanom Ghebreyesus, WHO Director-General. The Moscow Declaration to End TB is a promise to increase multisectoral action as well as track progress, and build accountability. It will also inform the first UN General Assembly High-Level Meeting on TB in 2018, which will seek further commitments from heads of state. Dr Tedros said, “Today marks a critical landmark in the fight to end TB. It signals a long overdue global commitment to stop the death and suffering caused by this ancient killer. One of the main problems has been a lack of political will and inadequate investment in fighting TB. Today’s declaration must go hand-in-hand with increased investment." Global efforts to combat TB have saved an estimated 53 million lives since 2000 and reduced the TB mortality rate by 37%. However, progress in many countries has stalled, global targets are off-track, and persistent gaps remain in TB care and prevention. As a result, TB still kills more people than any other infectious disease. There are major problems associated with antimicrobial resistance, and it is the leading killer of people with HIV. The meeting was attended by ministers and country delegations, as well as representatives of civil society and international organizations, scientists, and researchers. Professor Veronika Skvortsova, Minister of Health, Russian Federation said, “Tuberculosis is a complex, multi-sectoral problem that requires a systemic and highly coordinated response to address the conditions which drive the disease. The accountability framework we have agreed to develop marks a new beginning, and, with WHO’s support to coordinate and track progress, we expect the Moscow Declaration to lead us forward to the high-level meeting of the UN General Assembly in 2018.” More than 1000 participants took part in the two-day conference which resulted in collective commitment to ramp up action on four fronts 1) Move rapidly to achieve universal health coverage by strengthening health systems and improving access to people-centered TB prevention and care, ensuring no one is left behind 2) Mobilize sufficient and sustainable financing through increased domestic and international investments to close gaps in implementation and research 3) Advance research and development of new tools to diagnose, treat, and prevent TB 4) Build accountability through a framework to track and review progress on ending TB, including multisectoral approaches. Ministers also promised to minimize the risk and spread of drug resistance and do more to engage people and communities affected by, and at risk of, TB.   ]]> https://biospectrumindia.com/news/22/9854/daily-drug-regimen-for-treatment-of-tuberculosis-introduced-by-health-ministry.html https://biospectrumindia.com/news/22/9854/daily-drug-regimen-for-treatment-of-tuberculosis-introduced-by-health-ministry.html Tue, 21 Nov 2017 11:55:00 +0530 The Ministry of Health & Family Welfare has recently announced the launch of daily regimen for TB patients across the country under The Revised National TB Control Programme (RNTCP). The ministry has been providing the thrice weekly regimen for the treatment of tuberculosis (TB), however it has now decided to change the treatment strategy for TB patients from thrice weekly to daily drug regimen using fixed dose combinations (FDC) for treatment. This change will bring transformation in the approach and the intensity to deal with this disease which accounts for about 4.2 lakh deaths every year. Depending upon the convenience of patient and practitioner free of cost, the daily FDC anti-TB drugs will be made available to private pharmacy or at private practitioners to dispense to TB patients who seek care in private sector. Current WHO Global TB Report, 2017 has reported that incidence of TB has reduced from 28.2 lakh to 27 lakh and mortality by 60 thousand over the last one year, which is a testimony of anti TB drive by Government of India. The Health Ministry will take this forward with all major hospitals, IMA, IAP and other professional medical associations to expand the access to daily FDC to all TB patients. The salient features of this treatment strategy are use of Ethambutol in continuation phase for all patients, drugs to be given daily (as against only 3 times weekly previously), fixed dose combination (FDC) tablets to be used which will reduce pill burden (as against separate 7 tablets previously), for children, child friendly formulations as dispersible tablets and use of Information Technology (IT) enabled treatment adherence support system.   ]]> https://biospectrumindia.com/news/22/9844/bengaluru-tech-summit-2017-witnesses-amalgamation-of-best-minds.html https://biospectrumindia.com/news/22/9844/bengaluru-tech-summit-2017-witnesses-amalgamation-of-best-minds.html Sat, 18 Nov 2017 22:20:00 +0530 Bengaluru TechSummit 2017, showcased the country’s progress in the technology and biotech sectors. The theme of the event “Ideate, Innovate, Invent” was experienced by visitors and delegates through all the sessions, conferences, seminars, special programmes and the exhibition. Hosted by the Department of IT & BT, Government of Karnataka, the three-day mega event is a creative mix of two flagship events- the 20th edition of Bengaluru ITE.biz and the 17th edition of Bengaluru India Bio under one platform. The summit was attended by 3173 delegates, 267 speakers, more than 11000 visitors, and 250 exhibitors on leading edge technologies that are changing the world and saw signing of ten MoUs that would have a significant impact on technology sector in the State. The three-day event was inaugurated on November 16, 2017, by the Hon’ble Chief Minister of Karnataka, Shri Siddaramaiah, in the presence of Ms Anne Berner, Hon’ble Minister for Transport and Communications, Finland, who was the Guest of Honor. In a progressive move to strengthen tech inclusion in rural areas, the State Government launched a unique project providing free wi-fi to 500 grama panchayats in the State. The project, which will roll out the benefit to all 2650 grama panchayats in future, is an indication of the Government’s commitment to an outcome driven development of the State.   The event saw the Government signing ten MoUs indicating the growing importance of the event. MoUs were signed with Virgin Hyperloop One, CoE for Data Science and AI, Intel, French MoU, 3M, NUMA, BT Policy, AR/VR India Report and Elevate Start up Directory. Thrust areas of partnership were hyperloop, intel and traffic management.   The event also hosted conferences and seminars were thought- leaders discussed issues on path-breaking topics like Internet of Things, GIS, Cybersecurity, Cloud and Big Data, AVGC, security 360 and AR/VR. The summit focussed on the biotech sector and its state-of-the-art technologies that are changing the world: personalized medicine, rare diseases and orphan drugs, bio therapeutics, agro biotech and new technology.   Creating a start-up culture: Karnataka is setting up centres of excellence in IoT, robotics, cybersecurity, data analytics and aerospace. “The State is poised to create 20,000 start-ups by 2020 and will mobilise Rs 2000-crore fund for start-ups and foster industry partnerships,” according to Industries Minister, R V Deshpande On the concluding day of the summit, there were roundtable discussions between select start-ups, the Government, VC firms and accelerators to identify and fulfil the needs of the start-ups. The session focused on solving problems specific to individual start-ups by extending the necessary support of the Government, VC, accelerators and incubators as per the requirement. The session established fruitful partnerships among all stakeholders of the start-up community and helped curate start-ups and explore the synergies that exist in the sector. Various sectors like IT/ITeS/IoT/AVGC/Biotech/MedTech/Agritech/Clean tech/Aerospace and Aviation participated. This opened new doors for Idea2POC and Elevate 100 winners.  Women Power at TechSummit: Bengaluru TechSummit had a separate event for women entrepreneurs on 16 November, 2017, titled “She Drives Technology" that highlighted women and their achievements in leading innovation in the IT and BT sectors and also how women returning to work can be a game changer for the sectors.   For the first time in the country, there was a B2B summit for animation, visual effects gaming and comics sector, hosted at the summit. Called the ‘Bengaluru AVGC Summit’ the event was a partnership between the Government of Karnataka and ABAI, the trade association for animation, visual effects, gaming and comics sector. Creativity to the fore: Mr Priyank Kharge, IT, BT and Tourism Minister for the State, was emphatic that the goal is to make the State the creative capital of India and this could be possible through summits like this where small developers were given free entry so they could interact with global majors like Turner/Cartoon Network, BBC, Disney, Hotstar and many others who were present at the event. The summit explored the future of path-breaking tech developments like Augmented Reality and Virtual Reality. The expert panel comprising renowned names from the industry explored the definitions of augmented reality and virtual reality and presented cases for both technologies. On 17 and 18, November, 2017, the summit hosted the "Bengaluru Maker Faire", an event for all those who believe in the “do-it-yourself” spirit for sharing their accomplishments and showcasing their work with an appreciative audience.  The event saw some of the leading technologists, hobbyists, tinkerers, artisans, and entrepreneurs interacting with one another to celebrate, inspire and get inspired. Speaking at the event, Mr Priyank Kharge said that the Government wants to “create a stimulating atmosphere and this kind of events would change the way the youth would impact a global change.” One of the highlights of the TechSummit was the Rural IT Quiz, which is a pioneering effort by the Department of IT, BT and S&T, Government of Karnataka in partnership with Tata Consultancy Services since the year 2000. The programme has enhanced IT awareness amongst students at the grassroots level, and helped them keep abreast of the latest developments in the State. The summit rewarded those who have made a significant contribution in the sectors with the presentation of the STPI IT Export Awards and Bio Excellence Awards. ]]> https://biospectrumindia.com/news/22/9841/karnataka-govt-partners-with-nasscom-for-data-science-and-ai.html https://biospectrumindia.com/news/22/9841/karnataka-govt-partners-with-nasscom-for-data-science-and-ai.html Sat, 18 Nov 2017 18:05:00 +0530 The Government of Karnataka has announced the launch of a Centre of Excellence for Data Science and Artificial Intelligence (CoE-DS&AI), with NASSCOM as its program and implementation partner. To be established with an estimated investment of 40 crores, the CoE will its first-of-its-kind port based on a public-private partnership model, and will accelerate the ecosystem in Karnataka by providing the impetus for the development of data science and artificial intelligence across the country. NASSCOM, through its partner ecosystem will work towards accelerating innovation, enabling industry-oriented research, promoting adoption of data-driven decision making by enterprises and enabling appropriate skills & talent development. This proposal has evinced great interest for the industry to collaborate and build collective capabilities for the industry and country in the cutting-edge area of Data Science & Artificial Intelligence. The Centre of Excellence will provide high-end technology capabilities, data, expertise, thought leadership, and curated programs to augment capabilities across academia, enterprises, government, and innovators / advanced start-ups. Shri Priyank Kharge, Minister for IT, BT & Tourism, Government of Karnataka, stated that Karnataka has led the IT revolution in India and has always been at the forefront in areas of science and information technology. This Centre of Excellence for Data Science & Artificial Intelligence will be a catalyst for the growth of data science and artificial intelligence, and provide a head-start to, not just the state, but India as a destination to develop global products and solutions. Mr. R Chandrashekhar, President, NASSCOM, added that businesses across the globe are undergoing rapid changes propelled by digital disruption. Considering the opportunity that emerging digital technologies that will provide in times to come, this CoE-DS&AI is strategically placed to provide data-backed solutions to many complex problems of the world. ]]> https://biospectrumindia.com/news/22/9834/health-ministry-introduces-daily-drug-regimen-for-treatment-of-tuberculosis-.html https://biospectrumindia.com/news/22/9834/health-ministry-introduces-daily-drug-regimen-for-treatment-of-tuberculosis-.html Fri, 17 Nov 2017 14:50:00 +0530 Under the Revised National TB Control Programme (RNTCP), Ministry of Health & Family Welfare has recently announced the launch of daily regimen for TB patients across the country. Current WHO Global TB Report, 2017 has reported that incidence of TB has reduced from 28.2 lakh to 27 lakh and mortality by 60 thousand over the last one year, which is a testimony of anti TB drive by Government of India. The Health Ministry has been providing the thrice weekly regimen for the treatment of tuberculosis (TB), however it has now decided to change the treatment strategy for TB patients from thrice weekly to daily drug regimen using fixed dose combinations (FDC) for treatment. This change will bring transformation in the approach and the intensity to deal with this disease which accounts for about 4.2 lakh deaths every year. The daily FDC anti-TB drugs will be made available to private pharmacy or at private practitioners to dispense to TB patients who seek care in private sector, depending upon the convenience of patient and practitioner free of cost. The Health Ministry will take this forward with all major hospitals, IMA, IAP and other professional medical associations to expand the access to daily FDC to all TB patients. The salient features of this treatment strategy are use of Ethambutol in continuation phase for all patients, drugs to be given daily (as against only 3 times weekly previously), fixed dose combination (FDC) tablets to be used which will reduce pill burden (as against separate 7 tablets previously), for children, child friendly formulations as dispersible tablets and use of Information Technology (IT) enabled treatment adherence support system. ]]> https://biospectrumindia.com/news/22/9831/patanjali-asks-government-to-exempt-ayurvedic-medicines-from-gst.html https://biospectrumindia.com/news/22/9831/patanjali-asks-government-to-exempt-ayurvedic-medicines-from-gst.html Thu, 16 Nov 2017 18:30:00 +0530 Baba Ramdev-led Patanjali has asked the government to include all kinds of ayurvedic medicines under the nil Goods and Services Tax (GST) category. Currently, unbranded ayurvedic medicines attract five per cent GST rate whereas all branded ayurvedic medicines, including classical and patented, are taxed at 12 per cent. Earlier in October, the government had reduced rates on unbranded ayurvedic medicines from 12 per cent to five per cent. But it is unlikely that even the low GST rates will bring down the cost of ayurvedic medicines. According to the amendment in the tax rate, the five per cent benefit can be availed only if the labels on the products are free of the manufacture’s name, emblem or colour, thus, putting the product in the unbranded category. However, the catch here is that no ayurvedic product can actually come into the market without the manufacturer’s name or emblem as those products would be in violation of Drugs and Cosmetics Act. Products found to be in violation of the rule could be subject to heavy fines. That effectively means that all ayurvedic medicines sold through organised channels attract a GST rate of 12 per cent. “What are unbranded ayurvedic medicines? Ayurved is always responsible to provide care and cure to the masses. Unbranded means anyone can make the mixture and sell it, there is no accountability. If I am accountable then I have to pay 12 per cent GST,” rued Patanjali's spokesperson SK Tijarawala. Pointing out that there is nothing called unbranded ayurvedic medicines, Tijarawala said that ayurvedic medicines can be classified under either classical or patented. “Ayurved is classified into two segments, classical and patented. Those products falling under the classical category must fall under the five per cent. Rather I think that classical should be completely exempted,” said Tijarawala. Making a strong case for the exemption of ayurvedic medicines under GST, Tijarawala pointed out that healthcare in the country was costly and since there was so much disparity between people in the country, ayurvedic medicines could really reach every last house in the country if the taxes levied on it were relaxed. “Patanjali believes that if ayurved is exempted from GST then the masses can get better care because we have a lack of infrastructure for allopathy and other modern medical system. Everyone cannot have access to allopathy. So, alternative medical systems like ayurveda should be given special treatment in our country where disparity is too much,” said Tijarawala. ]]> https://biospectrumindia.com/news/22/9830/cabinet-approves-agreement-between-india-and-belarus-.html https://biospectrumindia.com/news/22/9830/cabinet-approves-agreement-between-india-and-belarus-.html Thu, 16 Nov 2017 16:30:00 +0530 The Union Cabinet chaired by the Prime Minister has been apprised of the Agreement between the Indian National Science Academy (INSA) and the National Academy of Sciences of Belarus (NASB) on Scientific and Technological Cooperation for mutual benefit in the areas of science, technology, agriculture, etc. The Agreement is aimed at identifying, assessing, developing and commercializing globally competitive technologies from India and Belarus. It will support institutions in both countries by way of research, technology transfers, exchange of visits and joint workshops leading to scientific and economic benefit. The Agreement was exchanged on 12th September, 2017 at New Delhi during the visit of Belarus President H.E. Mr. Alexander Lukashenko. ]]> https://biospectrumindia.com/news/22/9829/bengaluru-technology-summit-2017-kick-starts-in-the-city.html https://biospectrumindia.com/news/22/9829/bengaluru-technology-summit-2017-kick-starts-in-the-city.html Thu, 16 Nov 2017 15:35:00 +0530 IT entrepreneurship and multi-disciplinary collaboration just got a mega boost. Beckoning creative networking on a global scale, Honorable Chief Minister Siddaramaiah launched the Bengaluru Technology Summit-2017 at Bengaluru Palace on 16th November in the presence of other dignitaries that included Guest of Honor,Ms. Anne Berner, Hon’ble Minister for Transport and Communications, Finalnd; Mr. R.V. Deshpande, Minister for LMI and Infrastructure Development, GoK; Mr. K.J. George, Minister for Bengaluru, Development and Town Planning GoK;  Shri Priyank Kharge, Minister for IT, BT and Tourism, D. Sudhakar, Chairman KEONICS, C.N. Ashwath Narayan, MLA Mallshwaram Constituency,  Dr. Subhash C Khuntia, Chief Secretary, Government of Karnataka, Shri S GopalaKrishnan, Chairman,VGIT& Co-Founder, Infosys, Ms. Vanitha Narayanan, Chairman, IBM –India, Dr. Omkar Rai, Director Technology Parks Of India.   Hosted by the Department of IT & BT, Government of Karnataka, the three-day mega event is a creative mix of two flagship events- the 20th edition of Bengaluru ITE.biz and the 17th edition of Bengaluru India Bio under one platform. The government chose the occasion to announce a unique programme to strengthen rural Karnataka: Free WiFi to grama panchayats, a move to ensure availability of comprehensive data to villagers at their fingertips. The project’s first phase will see 500 grama panchayats get free WiFi facility from Thursday (November 16, 2017). This is part of the Government’s ambitious programme of providing wireless local area networking facility to all the 2,650 grama panchayats in the State.    Here’s what all individuals within a radius of one kilometer from the WiFi-enabled grama panchayat will get: Free access to 100 MB data at high speed. This way, all government facilities will get accessible via internet. Chief Minister Siddaramaiah had this to say on the project: “Access to knowledge and information should not be confined only to the people in the urban areas but also should be made available to the rural people as well.’’ The project was seen as a clear indication of the government’s commitment to an outcome driven development of the State. The State IT, BT and Tourism Minister, Shri Priyank Kharge, said the initiative will be implemented in a phases. “The rural people, especially the youth, must get the facilities available to their urban counterparts and must get an opportunity to access the internet to get themselves enlightened, enriched and also to communicate or share data.” The 3-day mega event is the result of Karnataka combining its 2 flagship events- the 20th edition of Bengaluru ITE.biz and the 17th edition of Bengaluru India Bio under one platform, Bengaluru Technology Summit-2017, to facilitate creative collaboration between multi-disciplinary stakeholders and entrepreneurs from around the world. The summit also included separate element for women entrepreneurs on 16th November titled “She Drives Technology" by ‘She the People’ to highlight women leading innovation and how women returning to work can be a game changer for IT.  Dr. Kiran Mazumdar Shaw, Chairman VGBT & CMD, Biocon, addressed the development in the life sciences space and heralded in a new age of digital health using advanced technology, AI and data sciences. She highlighted that Bengaluru has around 250 biotech companies, and the plan is to take the bio economy to $ 100 billion by 2025. "Bengaluru stands as the fourth biggest startup hub in the world. Of all the startups, 60 per cent are in this state. We aim to target a huge number by 2020. We are very proud that 30 per cent of the entrpreneurs are women", she said. Ms. Vanita Narayanan further added - “Technology helps bring industries together and this goes a long way in influencing govt. policies. Technology has become a pervasive platform for all industries.” Ms. Anne Berner highlighted the need of the moment as data sharing. By giving an example of Finland she said “Instead of ownership of data, sharing data is better as it helps the overall infrastructure. Quality and speed will only increase as technology increases and with shorter delays in data transmission forecasting becomes more accurate and we have a high quality automated reality.” The grand summit will also co-locate "Bengaluru Maker Faire" on 17th and 18th November, a global event for all those who believe in the “do-it-yourself” spirit for sharing their accomplishments and showcasing their work with an appreciative audience and rub shoulders with other Makers. It is a place where technologists, hobbyists, tinkerers, artisans, craftspeople, entrepreneurs and the merely curious gather together to celebrate, inspire and get inspired! It is a place where technologists, hobbyists, tinkerers, artisans, craftspeople, entrepreneurs and the merely curious gather together to celebrate, inspire and get inspired! The mega event is also witnessing ‘Bengaluru AVGC Summit’ on 16-17th November, which will be held at ITC Windsor Manor. This is being organised for the first time in the country and is a partnership between the Government of Karnataka and ABAI, the trade association for animation, visual effects, gaming and comics sector. This unique platform is aimed at bringing together IP owners & developers, content creators and production houses interested in producing and co-producing creative content as well as bring selected international and national studios, producers, broadcasters, distributors and financiers to participate in this buyer, seller interface. There will also be a “Security 360” event from 17-19th November at Hotel Taj West End, which is being organised by the Government of Karnataka in partnership with Synergia Foundation. Security 360 will feature a range of key note presentations and panel discussions giving participants an unique opportunity to interact and learn from some of the finest strategic & security practitioners and strategic thinkers from all over the world. Ben Story, strategic marketing partner of Rolls Royce, had this to say regarding the issue of partnerships, “India has among the best engineers and we look forward to working with them.  The amount of flexibility, creativity and global mentality has led us to join forces with TCS. At Rolls Royce we believe in advancing cars through digitisation and the technology sector has a lot to do in the future of transport.” Once the Tech Summit and IT Expo were formally inaugurated, a CEO Roundtable took over the spotlight. Captains of the industry highlighted opportunities and issues facing the industry. The discussion had its broad theme as “How diverse technologies are converging to shape our world, impacting the society?” The Roundtable speakers dwelt extensively upon emerging technologies and how they are converging to change the game in various sectors. They drew attention to new business opportunities shaping up to create a better society. Emerging technologies such as Artificial Intelligence, Internet of Things, AR/VR were all part of that change. The discussions traced the evolving business models and new economies emerging out of these new convergent technologies. The focus was also on new challenges to revamp the traditional business models. Affordability, the innovation cycle and the economics of scale were well highlighted through the duration of the Roundtable. While Mr Vijay Chandru talked about the opportunities through IT-Biotech linkages. When questioned about the decision making capabilities of AI in healthcare he had this to say: “At no point will that be allowed to happen. Advances in AI will only increase the productivity and effectiveness of the system.”    Ms Nivruthi Rai’s intervention was about new age chips that can mimic the human mind and other revolutionary developments happening at Intel with respect to Artificial Intelligence. “AI has been a part of Intel, along with several other companies for almost half a century in terms of using AI for hiring, safety etc.” she said. A key argument made my Ms. Nivruthi was “Jobs don’t go away because of technology; jobs are created because of technology.” Shifting the focus to driver-less cars, Mr. Kamal Bali emphasized on the much needed push for electric vehicles. He then went on to trace the opportunities, possibilities and challenges for the Indian auto sector of the future.  Mr. Kamal also has a unique outlook on the labour market of India and said “We have enough manpower in India. Places to network, however, are limited.” For Mr. Nachiket Sukhtankar, the platform was apt to talk about technology skills, jobs of the future, impact of intelligent automation and driving better business outcomes with converging technologies. Another interesting talk was about responsible AI and the pitfalls of reckless AI practices by large corporates. The criticality of this was driven home by the reference to Elon Musk’s remark that unregulated AI can be an existential threat. ----------------         Lined up for the Tech summit are presentations of the STPI IT Export Awards and Bio Excellence Award in recognition of the outstanding achievements of IT & BT innovators. Over the next three days, Thought leaders, Technocrats, Researchers, Innovators, Investors and Policy Makers from different streams gathered at the event will participate in interdisciplinary dialogue. On the agenda are collaborations and emergence of disruptive technologies, path breaking products and unique services.  For women entrepreneurs, the summit had a separate element on November 16, titled “She Drives Technology" by ‘She the People.’ The objective was to highlight women leading innovation and how women returning to work can be a game changer for IT. ]]> https://biospectrumindia.com/news/22/9817/department-of-biotechnology-conducts-stakeholder-meet-on-ncs-tcp.html https://biospectrumindia.com/news/22/9817/department-of-biotechnology-conducts-stakeholder-meet-on-ncs-tcp.html Wed, 15 Nov 2017 12:35:00 +0530 In order to create awareness among all the Stakeholders particularly key Officials from Centre and State Government’s Agriculture and Horticulture Departments, Department of Biotechnology recently conducted the Stakeholder Meet on “National Certification System for Tissue Culture Raised Plants (NCS-TCP)” Tissue Culture Industries, Farmers and Mission Directors of State Horticulture Mission/ Senior Officials of Horticulture Department in the State’s dealing with tissue culture plants/quality planting material interacted to identify the way forward to realize the full potential of this certification system which in unique, dynamic and comprehensive in nature.  Government of India established the “National Certification System for Tissue Culture Raised Plants (NCS-TCP)” authorizing Department of Biotechnology, Ministry of Science & Technology as the Certification Agency vide the Gazette Notification dated 10th March 2006 under the “Seeds Act, 1966” for ensuring production and distribution of quality tissue culture planting materials. The purpose of NCS-TCP is to ensure production and distribution of quality tissue culture planting materials. NCS-TCP is a unique quality management system, first of its kind in the world which ensures recognition of Tissue Culture Production Facility for the production of quality planting material and certification of end products.  Currently, around 80 Companies are recognized. Two Referral Centre’s and five Test Laboratories are accredited under this system. The recognized companies are eligible for getting their planting material certified from the Accredited Test Laboratories. So far, more than 275 million Tissue Culture plants have been certified through this system.  In his keynote address, S. K. Pattanayak, Secretary, Department of Agriculture, Cooperation and Farmers Welfare, Ministry of Agriculture Cooperation and Farmers Welfare stressed on a system in which all tissue culture material would be procured from accredited laboratories and the need for participation of states in such a system. “lndia is doing very well in tissue culture research and that scientific institutions of international repute is now open for Indian scientists for new research. He underlined the need for fund for popularization of tissue culture from the Ministry of Agriculture”, he added. Professor K VijayRaghavan, Secretary Department of Biotechnology highlighted the strong foundation of partnership between farmers and scientific community and added the need to have a well-articulated project for new improved varieties for horticulture. “Since India is the only country to develop this certification system, this progress can be used for building capacities in the neighbouring countries and that it would be an important step in science diplomacy”, he added. Dr Renu Swarup, Senior Advisor, DBT highlighted the structure and current status of NCS-TCP and the impact it has made on production of quality materials in different states. She stressed on the need for popularising tissue culture plants across India by 2020 and enlisting the participation of the states in the process.  ]]> https://biospectrumindia.com/news/22/9816/m-venkaiah-naidu-releases-the-findings-of-india-state-level-disease-burden-report-.html https://biospectrumindia.com/news/22/9816/m-venkaiah-naidu-releases-the-findings-of-india-state-level-disease-burden-report-.html Wed, 15 Nov 2017 12:05:00 +0530 M Venkaiah Naidu, The Vice President of India has recently released the findings of ‘India State Level Disease Burden’ report of Indian Council of Medical Research (ICMR). J P Nadda, Union Minister of Health and Family Welfare, Anupriya Patel, Minister of State for Health and Family Welfare, Dr. Soumya Swaminathan, Secretary (DHR) and DG (ICMR) and Dr. Vinod Paul, Member, NITI Aayog were also present. The India State-level Disease Burden Initiative, a joint initiative between the Indian Council of Medical Research (ICMR), Public Health Foundation of India (PHFI), and Institute for Health Metrics and Evaluation (IHME) in collaboration with the Ministry of Health and Family Welfare, Government of India along with experts and stakeholders associated with over 100 Indian institutions, released the first comprehensive set of state-level disease burden, risk factors estimates and trends for each state in India to inform health planning to reduce health inequalities amongst states in India. These estimates are based on analysis of all identifiable epidemiological data from India over quarter of a century. Addressing the participants, the Vice President of India stated, “Achieving good health for all of India’s population is an important goal of the Government of India and a foundation for further social and economic development. The Vice President further stated that the health status of Indians has been improving since Independence. The life expectancy of a person born in India in 1960 was 40 years, which has increased to about 70 years now. Of every 1000 live children born in India in 1960, about 160 died in the first year, but now this death rate of infants is about a fourth of that level.” In his address, the Vice President cautioned that in order to do better, several things need to happen. These include higher priority for health in the country’s policy making and enhanced resources for preventive and public health measures. There should be adequate mechanisms at the ground level for keeping Indians healthy and for suitable healthcare when they fall sick. We should also have a solid knowledge system that enables comprehensive tracking of the health and disease burden trends in every part of the country.” Speaking at the function, J P Nadda said, “the Health Ministry along with the state governments and other important partners in the country is making serious efforts to enunciate provision for health services that are suitable for the health situation of particular state, mainly through the public sector. “In this regard, the data and results shared by the India State-level Disease Burden Initiative today in its report, scientific paper, and the online visualization tool will serve as a useful guide for fine-tuning data driven health planning specific for health situation of each state of the country.” Speaking at the function, Anupriya Patel said, “The data and results shared by the India State-level Disease Burden Initiative today in its report, scientific paper, and the online visualization tool will serve as a useful guide for fine-tuning health planning in each state of the country. The burden due to non-communicable disease and injuries has overtaken the burden due to infectious and maternal-child diseases in every state of India, though this happened in some states about three decades ago and in some other states more recently. This means that the more developed states that had this transition a long time ago need to go on a war footing to control the rapidly rising burden of major non-communicable diseases and injuries.” ]]> https://biospectrumindia.com/news/22/9810/revised-gst-rates-bring-smile-on-medical-technology-sector.html https://biospectrumindia.com/news/22/9810/revised-gst-rates-bring-smile-on-medical-technology-sector.html Tue, 14 Nov 2017 19:00:00 +0530 Medical Technology Association of India (MTaI) is overwhelmed to note that the GST rates for lenscare solution have been reduced by the government from 28 per cent to 18 per cent. In its official statement, association said, “We consider this a positive movement forward and in line with the recommendations we made. This begins the process of removing the rate anomaly and we are much thankful to the GST Council and Government for the same. We hope that eventually these rates would be further reduced to 12% slab in alignment with Contact Lens GST rate as that would augment consumer adoption of this product.” “We also acknowledge with thanks the correction made to the HSN classification for Intraocular lens in line with the internationally accepted code at the behest of representations made by MTaI, as the industry has been facing challenges in clearance of goods from customs and was having to pay an undeserved Basic Customs Duty of 2.5 per cent,” statement told. MTaI feels these are the steps in the right direction, ironing out the creases in the implementation of GST. This will go a long way to help restore business confidence, lower the prices for consumers, while at the same time facilitate ease of doing business for the trading community by way of reduced compliance requirements and associated costs.   ]]> https://biospectrumindia.com/news/22/9799/ieag-mr-group-commends-india-on-mr-vaccination-progress-.html https://biospectrumindia.com/news/22/9799/ieag-mr-group-commends-india-on-mr-vaccination-progress-.html Mon, 13 Nov 2017 11:55:00 +0530 The India Expert Advisory Group on Measles & Rubella (IEAG-MR) after reviewing the existing strategies and efforts towards measles elimination and control of rubella during the past two days with Ministry of Health & Family Welfare has commended India on the progress of the measles and rubella vaccination campaign. The expert member group concluded that ‘the country is on the right track’. The expert group consisting of national and international experts complimented India on the growing trend in MCV (measles containing vaccine) coverage, and the significant reduction in MCV-1st dose and MCV-2nd dose dropout rate which declined from 44% to 13%. There has also been a reduction of DPT booster dose and MCV2 missed opportunities from 43% to 7% . The group has advised for the MR vaccination campaign to cover the whole country by 2018. Presentably 13 states have been covered by the vaccination campaign. The most recent campaigns in Andhra Pradesh and Telangana were reviewed in detail, and the experts complimented both states for excellent performance and their innovations to achieve very high coverage. The Group has recommended to strengthen the surveillance for MR and to expand the MR laboratory network.  Preeti Sudan, Secretary (Health) stated, “The country is fully committed to achieving the goal of measles elimination and rubella control to protect its children from these diseases’. She commended the state governments along with partners who have supported these efforts. She also credited the concerted IEC and awareness campaign to address the barriers to the vaccination; and the appropriate programmatic and strategic modifications based on learnings during the different phases of the campaign for the success.” Dr. Robert Kezaala from UNICEF stated, “UNICEF salutes the Government of India in tackling such a major threat to children’s lives and wellbeing - through a combination of campaigns and the operation Indradanush. UNICEF as a children’s agency commits to walk the extra mile with the Government of India.” Applauding India’s efforts, Dr. Katrina Kretsinger, WHO HQ representative said that “India has shown tremendous leadership on advancing measles elimination and rubella control. It sets an important example globally, demonstrating best practices.”  Dr. Jacob John, the co-Chairman of the IEAG said, “Two doses of Measles vaccine fully protect children against measles infection. In the past while the 1st dose coverage was close to 90%, the 2nd dose lagged behind by 45%. Both the MR campaigns and IMI are dramatically reducing this gap.”  Dr. Jim Goodson from Centers for Disease Control and Prevention (CDC), Atlanta said that “the Government of India has a smart plan that capitalizes on previous investments for polio eradication by re-tooling existing information systems and resources for measles elimination. Measles surveillance data should continue to be used to identify any areas with children missed by vaccination, thereby contributing to measles elimination efforts in India.”  Measles kills an estimated 49,000 children in India each year, which is about 37% of the global deaths due to this disease. India has set an ambitious goal to eliminate measles from the country. Measles Rubella vaccine has been introduced in 13 states. It is planned to expand across the country, covering 41 crore children by the end of 2018.    ]]> https://biospectrumindia.com/news/22/9777/vice-president-inaugurates-mega-health-camp-in-andhra-pradesh-.html https://biospectrumindia.com/news/22/9777/vice-president-inaugurates-mega-health-camp-in-andhra-pradesh-.html Tue, 07 Nov 2017 12:15:00 +0530 Venkaiah Naidu recently inaugurated a Mega Health Camp at Andhra Pradesh and cautioned people against falling prey to illnesses caused by modern and sedentary lifestyles. Dr. Kamineni Srinivas, Minister for Health and Medical Education, Andhra Pradesh, Devineni Uma Maheswara Rao, Minister for Water Resources Management, Andhra Pradesh and other dignitaries were present on the occasion.  The Vice President expressed concern that lack of physical activity and modern dietary habits were causing lifestyle diseases. He said, “People should take physical activities like walking, jogging, cycling and practicing Yoga to lead a healthy life. He appealed the medical fraternity to educate and create awareness on the dangers of modern lifestyle diseases and the need to adopt preventive measures.” He further said that as against the WHO norm of one doctor per 1,000, there is one doctor per 1,700 population in India. To overcome the shortage of medical professionals in the country, a high-level committee of Planning Commission (Now NITI Aayog) has recommended the setting up of 187 more medical colleges by 2022, headed.  "The governments alone cannot meet the growing healthcare demands and wanted the private sector and NGOs to supplement the efforts of the government”, he added. He also appealed Centre and State governments to focus on improving healthcare services in rural and backward areas.  ]]> https://biospectrumindia.com/news/22/9764/president-of-india-inaugurates-21st-world-congress-of-mental-health.html https://biospectrumindia.com/news/22/9764/president-of-india-inaugurates-21st-world-congress-of-mental-health.html Thu, 02 Nov 2017 17:10:00 +0530 The President of India recently inaugurated the 21st World Congress of Mental Health organised by the World Federation for Mental Health in partnership with Caring Foundation and other institutions in New Delhi. Speaking on the occasion, the President said that “the World Congress of Mental Health is taking place in India for the first time. And it has come here at an appropriate moment. Mental health issues are acquiring a serious magnitude in our country. Our National Mental Health Survey 2016 found that close to 14 per cent of India’s population required active mental health interventions.” The President noted that those living in metropolitan cities and those who are young – whether in the productive age group, or children and teenagers – are most vulnerable to mental illnesses. In India, we have a young population, with 65 per cent of our people below the age of 35. And our society is rapidly urbanising. This leaves us staring at a possible mental health epidemic. “The biggest obstacle that mental health patients have to encounter is stigma and denial. This leads to the issue being ignored or simply not discussed. We need to talk about mental health issues and treat ailments such as depression and stress as diseases that can be cured – not as guilty secrets that must be pushed under the carpet. A major gap in combating the mental health challenge is that of human resources. India is a country with 1.25 billion people but just 700,000 doctors – less than one million. In the field of mental health, the scarcity is even more acute. There are only about 5,000 psychiatrists and less than 2,000 clinical psychologists in our country”, he added. Ram Nath Kovind said that India’s National Mental Health Programme is building 22 centres of excellence in the field of mental health. In parallel, the District Mental Health Programme has already covered 517 of the approximately 650 districts in India. It is taking the conversation about mental health to the grassroots of our society. The President expressed happiness that the World Congress will have sessions on yoga, meditation and traditional approaches to mental health. He stated that the example of yoga is very instructive. When people talk about yoga, they generally refer to its physiological benefits. However, the mental, psychological, and cognitive benefits of yoga are equally worthy of our study. He looked forward to feedback on the deliberations of the special session planned on the role of yoga in battling anxiety and depression – and in preventing the onset of mental health problems.   ]]> https://biospectrumindia.com/news/22/9763/india-uk-partnership-in-science-technology-and-innovation-reviewed-by-st-ministers.html https://biospectrumindia.com/news/22/9763/india-uk-partnership-in-science-technology-and-innovation-reviewed-by-st-ministers.html Thu, 02 Nov 2017 16:55:00 +0530 Science and Technology Ministers of India and UK recently reviewed the progress made in the India-UK partnership in science, technology and innovation which has been significantly intensified under the Newton-Bhabha programme. Union Minister for Science & Technology and Earth Sciences Dr. Harsh Vardhan had a meeting with UK Minister of State for Science, Research and Innovation Jo Johnson in New Delhi. Based on the shared principles of co-funding, co-development and co-creation multiple agencies both in India and UK are seamlessly contributing to the multifaceted cooperation which covers the three strands of people, project and translational research partnerships. Both the Ministers reiterated the spirit and essence of the Newton-Bhabha program which underlines that the scientific knowledge creation and its application is directed for the welfare of both the nations. In this context, Dr. Harsh Vardhan remarked that “harnessing science and technology for a better future of our people is the new spirit which drives the present Indo-UK cooperation.” In November 2016, UK was the partner country in the Technology Summit which was inaugurated by Prime Minister Narendra Modi and Theresa May.  The two Ministers welcomed the release of the scoping Indo-UK report on Antimicrobial Resistance which has been prepared to launch a virtual research centre to address the increasingly serious threat to public and animal health in both countries. To study the impact of atmospheric pollution on Human Health a programme has been launched and first campaign for taking observation in Delhi is scheduled to begin soon. Under Industrial R&D programme India and UK have made visible progress with support to 10 joint projects led by industries from both sides towards co-development of Clean Technologies and Affordable Healthcare devises. In the meeting between the Science Ministers, it was also informed that the India-UK Frontiers of Science Symposium is planned for summer of 2018 in UK which will bring the future science leaders across disciplines for brainstorming the future direction of the bilateral cooperation. ]]> https://biospectrumindia.com/news/22/9762/state-medical-colleges-link-up-for-cancer-care.html https://biospectrumindia.com/news/22/9762/state-medical-colleges-link-up-for-cancer-care.html Thu, 02 Nov 2017 12:35:00 +0530 The Government of Maharashtra, National Cancer Grid, Tata Memorial Centre, the Government of India’s Department of Atomic Energy, and Tata Trusts recently organised Maharashtra’s first Virtual Tumour Board (VTB) meeting, connecting the state’s government medical colleges to provide access to expert opinion to cancer patients from the state’s remotest corners from a multi-disciplinary panel of cancer experts from across the country. The VTB launch witnessed participation from 13 government medical colleges, Tata Memorial Hospital and other hospital members of the National Cancer Grid.  The inaugural session took place in the presence of Shri Girish Mahajan, Hon’ble Minister for Medical Education, Maharashtra. Shri Girish Mahajan, Minister of Medical Education, Government of Maharashtra said “I would like to thank Tata Trusts, Tata Memorial Center and the National Cancer Grid for this initiative. The Tata name has been associated with cancer care across the country for a long time. Tata is not only a business name but is also associated with health care. We are now able to start cancer care centers on the basis of the work done by the Tata hospitals both in this state and across the country for which we are grateful. Through these colleges and the virtual tumour board, people in the remote areas of our state can now get an accurate diagnosis, proper and affordable treatment.” Mr. R. Venkataramanan, Managing Trustee, Tata Trusts, said, “There is an acute shortage of skilled manpower, especially oncologists, in the country to provide adequate care to the 14.5 lakh new cancer cases every year. Today, we move beyond our conventional ways of working and remote care models like this will go a long way to promote use of technology to decentralize cancer treatment and hence enable access to high quality cancer care in the state's remotest corners. Tata Trusts are pleased to partner With the Govt of Maharashtra and be working with the medical colleges in making this happen.” Burzis Taraporevala, CFO and Company Secretary, Tata Trusts, said, “The National Cancer Grid which was started about 5 years ago is responsible for connecting various hospitals towards improved cancer care. In these five years, we have through Internet connectivity and bandwidth connected about 120 hospitals and cancer care units. This virtual tumour board allows 40 or 50 of these cancer hospitals and centers to come together to discuss these cases and arrive at a conclusion as to the most effective and affordable treatment for the patient. This is the first time in history that this kind of grid has come about and the role of Tata Trusts is to see that through proper bandwidth and connectivity skills and care are improved, such that there is affordable and accessible care and at the same time the care is of good quality.” This pioneering effort by the Maharashtra Government aims to provide both evidence based cancer care and upgrade skills and knowledge of clinical staff, in line with the Prime Minister, Mr. Nardenra Modi, and the Chief Minister, Mr. Devendra Fadnavis’ thrust to enhance research capability and capacity in the sector. The initiative is being led by the National Cancer Grid (NCG), an initiative of the Tata Memorial Centre and Department of Atomic Energy, which is a network of 124 major cancer centres in the country with the mandate of establishing uniform standards of patient care for prevention, diagnosis and treatment of cancer, providing specialized training and education in oncology and facilitating collaborative research in cancer. Tata Trusts are providing the National Cancer Grid centres and the Government Medical Colleges in Maharashtra with high bandwidth enterprise level connection. This will enable the colleges to fully utilize and benefit from various NCG initiatives including the Virtual Tumour Board, NCG Digital Library, e-resources and publications to name a few.  The VTB comprises of experts from the fields of medical oncology, radiation oncology, surgical oncology, anaesthesiology, pathology, imaging technology as well as others leading government-run and private hospitals. The VTB establishes a platform where complicated cases of cancer patients are discussed through a multipoint video conference to get opinions on diagnosis and treatment. The discussions are web-based and conducted every Saturday where some centres present the cases while others give their opinions. This enables hospitals even in remote areas to access opinions from leading experts in the country. The ultimate goal is to eventually reduce the need for patients to travel to major cities while contributing to the garnering of knowledge for developing contextual, locally appropriate, peer reviewed protocols, policies and guidelines for the state and for the nation.     ]]> https://biospectrumindia.com/news/22/9746/karnataka-govt-to-work-on-health-technologies.html https://biospectrumindia.com/news/22/9746/karnataka-govt-to-work-on-health-technologies.html Tue, 31 Oct 2017 12:00:00 +0530 The State government recently signed a Memorandum of Understanding (MoU) for three years with the Union health ministry’s Department of Health Research. The objective is to undertake Health Technology Assessment (HTA). The Department of Health Research has set up India’s first HTA agency, Medical Technology Assessment Board (MTAB), to assess cost-effectiveness of health interventions. MTAB aims to reduce the cost in patient care, expenditure on medical equipment, overall cost of medical treatment, reduction in out-of-pocket expenditure of patients and streamline the medical reimbursement procedures. As part of the agreement, it will assess medical devices, drugs, medical and surgical procedures. The assessment will include evaluation of medical effectiveness, cost effectiveness, efficacy, safety, psychological, social, ethical organisational and economic aspects of it. The results of these evidence-based studies will be used for policy-making. Every state government, agency, health programme, for example, the Non-Communicable Disease Programme and the National Vector-Borne Disease Control Programme can use HTA to understand how best their resources can be used. ]]> https://biospectrumindia.com/news/22/9741/icmr-hands-out-ipr-guidelines-to-scientists.html https://biospectrumindia.com/news/22/9741/icmr-hands-out-ipr-guidelines-to-scientists.html Mon, 30 Oct 2017 11:55:00 +0530 The Indian Council of Medical Research (ICMR) has recently taken out a booklet on Intellectual Property Rights & Technology Transfer which will help increase awareness among ICMR scientists for protecting new technologies. This document, which has detailed FAQs on Intellectual Property Rights (IPR), is an effort by the ICMR in the direction to increase awareness of IP protection before publication. The booklet has been prepared by a group of experts under the chairmanship of Professor Seyed Hasnain. Ever since its creation in 1999, the IPR Unit at ICMR has been striving hard to promote innovation and research that would lead to patentable leads. The Unit has geared itself over to create an inventor-friendly system for scientists to consider protection of new knowledge created as new intellectual property before publication in peer reviewed journals. For the past many years, scientists working with the support from the Indian Council of Medical Research have been carrying out high quality research to achieve its objectives. Any new information or data generated in the laboratory are immediately published for its widest dissemination and application for public good. In line with this, a new system has been devised for ensuring that the new inventions or leads obtained in the laboratory are eligible for patent protection. For this purpose, a simple reporting proforma has been designed to help researchers report their new inventions. This system has worked reasonably well and many researchers (both intra and extramural) are becoming increasingly conscious of the need and importance of protecting such new knowledge generated through appropriate IPR systems before publication.   ]]> https://biospectrumindia.com/news/22/9732/government-to-focus-on-making-india-anemia-freeunion-health-secretary.html https://biospectrumindia.com/news/22/9732/government-to-focus-on-making-india-anemia-freeunion-health-secretary.html Fri, 27 Oct 2017 11:05:00 +0530 The inaugural ceremony of the IAAH 11th World Congress on Adolescent Health, ‘Investing in Adolescent Health – the Future is Now’, was held on 26 October 2017 in New Delhi Inaugurating the IAAH 11th World Congress on Adolescent Health, Preeti Sudan, Secretary Ministry of Health and Family Welfare on said, “The government was in the process of putting in place dedicated, preventive and promotive strategies in schools to make India anemia-free.Over 50% adolescents and women in India are anemic. We need to consolidate clinical and public health initiatives for the well-being of adolescents. Various programmes being run by different Ministries for adolescents need to be integrated for better outcomes.” “India has some pathbreaking legislations on HIV and Mental Health and had a comprehensive National Health Programme for Adolescents – Rashtriya Kishore Swasthya Karyakram (RKSK) launched in 2014 across 230 districts”, she added. The world is home to 1.2 billion adolescents, and India has the largest population of adolescents in the world – 253 million[1] with every fifth adolescent in the world being an Indian and every second adolescent being an Asian. Dr. Vinod Paul, Member, NITI Aayog, said “anemia was a bigger challenge though we often speak of non-communicable diseases which need to be dealt with urgency.” Pointing out that youth was India’s future, he said if India had to benefit from the demographic dividend, it was important to invest in adolescent health. Talking about the challenges, he said there was a dearth of quality data on adolescents and implementing the ambitious adolescent health programme on the ground was equally tough. Professor Susan Sawyer, President, International Association for Adolescent Health said, “It was for the first time that there was a strategy in place for women, children and adolescents. Adolescence is a critical time in the growth of an individual, and now was the time to invest in them.” “India with over 253 million adolescents was significantly investing in adolescents, children, and women, adding that this was the largest meeting of the IAAH with representation from all regions of the world”, she added. Dr. Sunil Mehra, Executive Director, MAMTA Health Institute for Mother and Child said that there was a strong contingent of young people at the World Congress who can guide us to draft our future policies. He said the participants would learn and share problems, challenges, actions and resources during the deliberations.         ]]> https://biospectrumindia.com/news/22/9722/bimstec-meeting-inaugurated-by-ministry-of-ayush-.html https://biospectrumindia.com/news/22/9722/bimstec-meeting-inaugurated-by-ministry-of-ayush-.html Thu, 26 Oct 2017 11:30:00 +0530 Ministry of AYUSH hosted the first meeting of BIMSTEC task force on Traditional Medicine on 24-25 October, 2017 at Parvasi Bhartiya Kendra, New Delhi. The Bay of Bengal Initiative for Multi-Sectoral Technical and Economic Cooperation (BIMSTEC) is an International Organisation involving a group of countries in the South Asia and South East Asia namely, Bangladesh, India, Myanmar, Sri Lanka, Thailand, Bhutan and Nepal. India being a major stake holder in the field of Traditional Medicine plays an important role in influencing the policies and strategies related to the Traditional Medicine in the BIMSTEC Forum Delegations from the People’s Republic of Bangladesh, the Kingdom of Bhutan, the Republic of India, and the Republic of the Union of Myanmar, the Federal Democratic Republic of Nepal, the Democratic Socialist Republic of Sri Lanka and the Kingdom of Thailand along with the BIMSTEC Secretariat participated in the Meeting. The Meeting was inaugurated on 24 October 2017 by Vaidya Rajesh Kotecha, Secretary, Ministry of AYUSH. While welcoming the delegates from the BIMSTEC Member States, Secretary AYUSH referred  to the rich heritage of Traditional systems of Medicine in the BIMSTEC Member States. He also emphasised that the “BIMSTEC Forum provides an ideal platform for fostering collaborations among the Member States in the area of Traditional Medicine. He highlighted the recent developments in the International Cooperation activities of the Ministry. He hoped that the deliberations during the Meeting would bring fruitful outcomes in strengthening the cooperation amongst the BIMSTEC Member States in areas of Traditional Medicine.” Pramod Kumar Pathak, Joint Secretary, Ministry of AYUSH and Head of Delegation of India was elected Chairman of the Meeting and  Dr Yi Yi Myint, Head of Delegation of Myanmar was elected  Vice-Chair. All the Delegations made Country Presentations on the status and best practices of Traditional Medicine in their respective country.  Some of the important points discussed in the meeting were: Implementation of Strategies of BIMSTEC Task Force on Traditional Medicines (BITFM) Priority Areas for technical and research collaboration among the Member States on Traditional Medicine Regional strategy on the protection of Genetic Resource associated with Traditional Medicine Knowledge and Intellectual Property Rights and develop a work plan Human Resource Development and Capacity Building among the BIMSTEC Member States New Initiative, proposals and programmes for cooperation on Traditional Medicine among the BIMSTEC Task Force on Traditional Medicine. The Meeting also acknowledged that in accordance with the ToR of the Task Force, the BTFTM Meetings shall be held on rotational basis among the BIMSTEC Member States. The Meeting considered and adopted the draft Report of the First Meeting of the Task Force for submission to the Fourth Meeting of the BNNCCTM to be held in Bangladesh.   ]]> https://biospectrumindia.com/news/22/9719/ontario-collaborates-with-biolab-pharma-to-create-life-sciences-jobs-.html https://biospectrumindia.com/news/22/9719/ontario-collaborates-with-biolab-pharma-to-create-life-sciences-jobs-.html Thu, 26 Oct 2017 11:15:00 +0530 Ontario, Canada is partnering with Biolab Pharma that develops manufactures and commercializes prescription medicine and is a leader in cardiology and dermatology drugs . This will help the company retrofit its first international facility outside Brazil, creating 40 new highly skilled jobs in the province. With support from Ontario’s Jobs and Prosperity Fund, the company is retrofitting a 13,000 sq foot research development and innovation (RD&I) facility in Mississauga. It will also invest in new equipment and special software to improve its research capabilities. These enhancements will help the company develop and commercialize innovative products for the North American and European markets. Brad Duguid, Minister of Economic Development and Growth said, “Our government is excited that Biolab Pharma chose Ontario for its first international site. Today’s announcement is a testament to the province’s competitive and innovative life sciences sector and highly skilled workforce. This is an excellent example of how strategic partnerships can help drive economic growth and create high value jobs in the province.” Ontario is North America’s seventh-largest economy and Canada’s largest centre for banking, insurance and capital markets. Ontario’s diverse and innovative economy, with its educated and talented workforce, low business costs and generous incentives for R&D make it one of the best places in the world to do business and invest. Ontario is the largest life sciences jurisdiction in Canada with more than 50 per cent of the country’s total life sciences economic activity. Ontario’s life sciences sector employs approximately 60,000 people. Charles Sousa, Minister of Finance said, “Ontario’s private sector is at the forefront of economic growth, tapping into our highly skilled workforce to fill the jobs of tomorrow. Through the Jobs and Prosperity Fund alone, businesses have created or retained more than 35,000 jobs, including 40 announced today at Biolab Pharma. These partnerships contribute to the strong and sustained growth of the Ontario economy, with over 794,500 net new jobs created since the recession. We are proud that our strategic investments are helping businesses across Ontario grow and prosper.” Ontario is investing up to $2.8 million through the Jobs and Prosperity Fund for this project. This is part of a larger overall investment by the company valued at $57.4 million. The project is scheduled for completion in December 2022.  Cleiton de Castro Marques, CEO, Biolab Pharma Ltd said, “We are pleased to partner with the Ontario government on this exciting initiative as we expand our operations internationally. Our new facility will help us sharpen our competitive edge and better serve our customers by continually improving and creating innovative products.” ]]> https://biospectrumindia.com/news/22/9718/government-unleashes-website-to-elevate-medical-tourism-in-india.html https://biospectrumindia.com/news/22/9718/government-unleashes-website-to-elevate-medical-tourism-in-india.html Wed, 25 Oct 2017 15:35:00 +0530 In order to promote India as a hot destination for healthcare services, The Union Ministry of Commerce and Industry along with ministries of Tourism and Health has launched a website. The website is a single-source platform providing a comprehensive information to medical travellers on the top healthcare institutions spread across major cities of the nation —highlighting its speciality in various medical treatment, wellness and rejuvenation, and Ayurveda & Alternative medicine. The Union Ministry of Commerce and Industry along with ministries of Tourism and Health has launched a website designed to promote  India as a premier healthcare destination. “Over the years, India has grown to become a top-notch destination for medical value travel because it scores high over a range of factors that determines the overall quality of care,” the website, indiahealthcaretourism.com reads that also supports Arabic, Russian and French languages. Once the traveller selects one or a few hospitals from the portal, an ID is provided used to stay connected with the respective hospital staff. In addition, the hospital would also provide assistance to the medical travellers in obtaining medical visas. It sends them an invitation letter which needs to be presented at the ‘Embassy’ or ‘High Commission’ of India based in their respective country. ]]> https://biospectrumindia.com/news/22/9714/president-of-india-meets-scientists-at-iisc.html https://biospectrumindia.com/news/22/9714/president-of-india-meets-scientists-at-iisc.html Wed, 25 Oct 2017 12:50:00 +0530 Ram Nath Kovind, The President of India visited the laboratory and the Centre for Nano Science and Engineering (CeNSE) at the Indian Institute of Science (IISc), Bengaluru on 24 October 2017. He participated in a roundtable discussion with scientists at IISc, Bengaluru. Dr R. Chidambaram, Principal Scientific Adviser to the Government of India; Professor Anurag Kumar Director, IISc; Dr K. Vijay Raghavan, Secretary, Department of Biotechnology; Dr Ashutosh Sharma, Secretary, Department of Science and Technology; Shri K.K. Sharma, Secretary, Higher Education, Ministry of Human Resource Development; Shri Kiran Kumar, Chairman, ISRO; Dr S. Christopher, Chairman, DRDO and other scientists were also present for the roundtable conference. Addressing the scientist community, the President said that “Knowledge, Discovery and Innovation are three of the four wheels that take a country forward. The fourth is our Society. Each wheel must move in co-ordination, in pace and in the right direction. The slightest misstep by one will take us in the wrong direction or stall us. Scientists have an immense responsibility. They are directly in charge of three wheels. But unless they connect every day with the fourth, society, we have no future.” “India faces enormous challenges. We are to lift our people out of poverty, ensure their health and well-being and ensure our food and energy security. Society rightly demands solutions to these problems. On the other hand, scientists must not compromise their quest for knowledge – from atoms to galaxies. And these two endeavours are not contradictory”, he added. The President also said that we have seen how ISRO has succeeded through the efforts of the late Dr Satish Dhawan in combining cutting-edge science with helping farmers. And in linking ISRO’s research, applications and innovation with the academic capacities of IISc. The challenge is to replicate that partnership and that synergy, across institutions and across disciplines. “Scientists have the opportunity to pioneer a revolution where all the scientific institutes in Bengaluru work together. They can share their strengths and show by example how science and technology can take us to new heights. The spark from their efforts in Bengaluru can light the flame of knowledge all over the country. It can help take the culture of innovation further and deeper from lab to shop floor, right down to school classrooms”, he also added. Leading scientists from Bengaluru presented a flavour of their plans for a paradigm shift in the way their efforts have become more collaborative and thereby more effective. In addition to IISc, scientists from JNCASR, inStem, NCBS, the Raman Institute and the Indian Institute of Astrophysics were present. The speakers pointed out that India has shown leadership in astronomy and mega- physics as well as materials research. In bio-technology too, our research is at global levels. The science leaders said that there is a sense of shared purpose and collaboration to take on new challenges and help achieve the goals of New India 2022.    ]]> https://biospectrumindia.com/news/22/9711/kerela-govt-collaborates-with-uk-for-healthcare.html https://biospectrumindia.com/news/22/9711/kerela-govt-collaborates-with-uk-for-healthcare.html Wed, 25 Oct 2017 11:40:00 +0530 The Kerala government has collaborated with a UK university for making changes in its healthcare model. The main objective is to address issues surrounding capacity development for primary care, training and research. The model will be based on UK’s state-owned National Health Service (NHS), the largest and the oldest single-payer healthcare system in the world that provide healthcare benefits to every citizen. Recently, a delegation led by Kerala’s Health Minister K K Shylaja Kumari concluded a two-day visit to the University of Warwick in central England to explore how the general practitioner (GP) system has adapted to pressures caused by population changes. The delegation also visited the University Hospital of Coventry and Warwickshire (UHCW) NHS and local general practices in Coventry city centre, along with local clinicians and members of the academic unit for primary care at Warwick Medical School. Kerala has the highest literacy rate and the highest life expectancy in India, and is experiencing a rapidly aging population and an increase in non-communicable diseases such as diabetes. In order to address these issues, the Kerala government is planning to establish training programmes to teach primary healthcare workers such as GPs and nurses. ]]> https://biospectrumindia.com/news/22/9705/icmr-to-focus-on-raising-health-research-output.html https://biospectrumindia.com/news/22/9705/icmr-to-focus-on-raising-health-research-output.html Tue, 24 Oct 2017 12:00:00 +0530 Indian Council of Medical Research (ICMR) plans to raise the national health research output by 30 percent and to launch at least 10 globally validated Indian traditional medicines by 2030. The ICMR Strategic Plan-2017-24 is based on five major pillars of capacity building, data management, leveraging traditional medicine, evidence to policy and strengthening program implementation through research. ICMR aims to adopt a three-pronged approach of customised courses for undertaking advanced high end and basic start-up health research; strengthening the available infrastructure in elite research institutions, medical colleges, research institutions; and establishment of centres of excellence and regional mentorship hubs. ICMR also plans to acquire an independent university or equivalent status to strongly position itself as a teaching agency and provide an opportunity to students to obtain a postgraduate or doctoral degree under the ICMR brand. The apex body that oversees biomedical research in the country plans to produce 100 PhDs per year, in addition to training 5,000 health personnel annually through ICMR regional hubs by 2030. ICMR will also aim to produce at least 300-500 A-star scientists in the area of health research. ]]> https://biospectrumindia.com/news/22/9702/big-us-firms-to-meet-adityanath-under-us-in-up.html https://biospectrumindia.com/news/22/9702/big-us-firms-to-meet-adityanath-under-us-in-up.html Mon, 23 Oct 2017 15:05:00 +0530 With the tagline "US in UP", 26 major American companies will interact with Uttar Pradesh Chief Minister Yogi Adtiyanath to explore investment opportunities in the state. "Headed by Boeing, 26 US firms are on their way to Uttar Pradesh to explore investment avenues in the state. The tagline is 'US in UP' on the lines of 'Vibrant Gujarat'," senior cabinet minister Siddharth Nath Singh told. The delegation will visit the state under the aegis of US-India Strategic Partnership Forum (USISPF), Singh, who is UP Health Minister, said. The USISPF is committed to creating the most powerful strategic partnership between the US and India and promoting bilateral trade is an important task, the Forum said. "But, our mission reaches far beyond this. It is about business and government coming together in new ways to create meaningful opportunities that have the power to change the lives of citizens," the USISPF said. It said in a statement that investment incentives offered by the state under the new chief minister "translate into a business-friendly climate for industry." Singh said taking a cue from 'Vibrant Gujarat', the idea of 'US in UP' has been mooted to showcase the state's investment avenues in chemicals, petrochemicals, pharmaceuticals, cement, gems, textiles and engineering sectors. He said a small delegation had visited this state two months back and realising the "tremendous investment potential" in the state, a bigger delegation will be travelling to the state tomorrow. Singh said the foundation for the high-profile tour was laid when Prime Minister Narendra Modi visited the United States in June and invited CEOs of top US companies to invest in India, saying GST was a game changer that made the country a business-friendly destination. UP Chief Secretary Rajive Kumar will brief the delegation on investment opportunities along with the UP Industries Development commissioner and principal secretary for industries. ]]> https://biospectrumindia.com/news/22/9681/assam-to-get-a-cancer-care-grid-soon.html https://biospectrumindia.com/news/22/9681/assam-to-get-a-cancer-care-grid-soon.html Tue, 17 Oct 2017 14:15:00 +0530 Assam Health Minister Dr. Himanta Biswa Sharma revealed that a South Asian Cancer Research Centre and a three-level cancer care grid is likely to come up in Assam soon. This development was followed by the Minister’s meeting with Ratan Tata and members of Tata Trusts at Mumbai recently. Assam Government and Tata Trusts are working on setting up a unique three level cancer care grid that is first of its kind. The grid is being established at state, capital and district levels. It is likely to have an investment of Rs. 1400 crores and would be accordingly shared between Tata Trusts and the state. The first level or L1 of the cancer care grid will have advanced, tertiary care facilities. The second level (L2) will be equipped with chemo, radiation and surgical oncology. And the third level or L3 will have day care, chemotherapy and radiation facilities. On the same line, a South Asian Cancer Research Centre will be established for undertaking research on identifying reasons and developing protocols for effective treatment with a focus on South Asia. ]]> https://biospectrumindia.com/news/22/9678/indias-first-global-conference-on-adolescent-health-to-focus-on-investing-in-youth-for-a-healthy-new-india-.html https://biospectrumindia.com/news/22/9678/indias-first-global-conference-on-adolescent-health-to-focus-on-investing-in-youth-for-a-healthy-new-india-.html Tue, 17 Oct 2017 12:10:00 +0530 The World Congress on Adolescent Health is coming to India. Held only once every 4 years, the International Association for Adolescent Health’s 11th World Congress on Adolescent Health, ‘Investing in Adolescent Health – the Future is Now’ will be held in New Delhi, India from 27-29 October 2017. The world is home to 1.2 billion adolescents, and India has the largest population of adolescents in the world i.e. 253 million. This demographic makes India a potent host for a global conference on this theme. According to Manoj Jhalani, Additional Secretary & Mission Director, MoHFW “The National Health Mission guidelines on adolescent health are a step forward in ensuring a healthy, young India. The government of India is deeply committed to streamlining efforts to ensure comprehensive approaches to dealing with adolescent health. Through various programmes and initiatives, different aspects of adolescent health including nutrition, sexual and reproductive health, NCDs, mental health and more, are being addressed in tandem with each other, incorporating a much-needed life-course perspective into overcoming public health challenges.” The agenda for Sustainable Development Goals 2030 and the new Global Strategy on Women’s Children’s and Adolescents’ Health have brought adolescence to the centre-stage. These agendas recognize the opportunities and contribution of adolescence to achieving a wide array of global health priorities including improvements in communicable diseases (e.g. HIV) and non-communicable diseases, women’s health, mental health, nutrition, and more.  For example, over half of new HIV cases occur in adolescents, and more than 2 million adolescents are living with HIV. Addressing the global HIV epidemic – and other key global health agendas, will not be achieved without attending better to adolescent health and wellbeing.   According to Vandana Gurnani, Joint Secretary, MoHFW "With the largest number of adolescents in the world, India is being watched by the world with hope, and we must lead the way in setting examples through our commitment to securing the health of young India. The upcoming World Congress, therefore, could not have come at a better time for India.” Dr. Ajay Khera, Deputy Commissioner, MoHFW, says “The Ministry of Health and Family Welfare is very happy to support the ‘11th World Congress on Adolescent Health’ being held by the International Association for Adolescent Health (IAAH). We are giving the highest priority to addressing adolescent health issues, and ensuring a healthy and bright future for our adolescents. Programmes like RKSK don’t just address maternal and child health needs but also talk about the risks of non-communicable diseases and drug abuse, and the necessity of addressing mental health issues.” The World Congress will cover topical themes through discussions in sessions such as ‘Global adolescent health: Opportunities and challenges’, ‘Programming for adolescent health in India: RKSK and beyond’, ‘Toward a gendered approach to adolescent health’, ‘Mental health and adolescents’, and more. The conference which is the first-of-its kind to be held in India will see the participation of prominent global public health experts as well as policy makers. The World Congress is being organized under the supportive leadership of the Ministry of Health & Family Welfare, Government of India. MAMTA Health Institute for Mother and Child (MAMTA) is the lead organisation that is hosting the World Congress with a consortium of partners including Pathfinder International, Population Foundation of India (PFI), Population Services International (PSI), and The YP Foundation. The World Congress also has scientific support from Indian Academy of Pediatrics (IAP), Federation of Obstetric and Gynecological Societies of India (FOGSI), Public Health Foundation of India (PHFI) and Trained Nurses Association of India (TNAI). Professor Susan Sawyer, President, International Association for Adolescent Health, says, “This meeting couldn’t be better timed, as never before has there been such global recognition of the importance of advancing the health and wellbeing of adolescents, including in India. IAAH is delighted that the 11th World Congress on Adolescent Health is in the country with the largest number of adolescents in the world. A groundswell of professionals, global partners and young people are coming to Delhi from all over the world to share ideas, evidence and actions to advance adolescent health. The world is looking towards India and we are confident this World Congress will deliver.”   ]]> https://biospectrumindia.com/news/22/9676/icmr-releases-stringent-guidelines-for-stem-cell-research.html https://biospectrumindia.com/news/22/9676/icmr-releases-stringent-guidelines-for-stem-cell-research.html Mon, 16 Oct 2017 18:20:00 +0530 The national guidelines for stem cell research (2017) made by the Indian Council of Medical Research (ICMR) is looking at suspending commercial banking of stem cells derived from biological materials such as cord tissue, placenta, tooth extract and menstrual blood. In the recommendations made by ICMR, it has been stated that there is no scientific evidence to substantiate the clinical benefits of these stem cells. Accordingly, the ICMR has issued guidelines stating that commercial banking of all biological materials, other than umbilical cord blood, is not permitted until further notification. At the same time, ICMR has approved the stem-cell treatment for 30 odd categories of diseases mostly cancer. The apex medical research agency listed 20 types of indications (diseases) for adults and another 13 categories of indications for children below 18 years, where stem cell treatment are permitted. Besides cancers, some complicated congenital diseases are on that list. The guidelines also mention that every other therapeutic use of stem cells shall be treated as investigational and conducted only in the form of a clinical trial after obtaining necessary regulatory approvals. ]]> https://biospectrumindia.com/news/22/9673/dr-harshvardhan-inaugurates-women-bio-tech-incubator-in-chennai.html https://biospectrumindia.com/news/22/9673/dr-harshvardhan-inaugurates-women-bio-tech-incubator-in-chennai.html Mon, 16 Oct 2017 15:50:00 +0530 Dr. Harshvardhan, Union Minister of Science & Technology has recently inaugurated Women Bio-tech Incubator at Golden Jubilee Biotech Park for Women Society. It was inaugurated during IISF, 2017 in Chennai in the presence of Prof. M. S. Swaminathan, Founder Chairman, Women Biotech Park,  and M C Sampath, State Minister of Industry, Government of Tamilnadu. While delivering the Conclave Address Dr. Harshavardhan said that, “Globally there has been a special focus on addressing the issues related to Women in Science and framing policies which support the same. In India we have laid special emphasis on empowerment of women. Prime Minister Narendra Modi has stressed upon the need for special programmes which not only technically empower the women but also create employment opportunities.” “In the field of Science and Technology and Entrepreneurship, Indian women have had a major presence over the last 100 years. The DST and DBT have special schemes to attract women scientists and to provide employment opportunities to the unemployed women scientists. Women Entrepreneurship is a very important activity that has been growing rapidly in last few years. “Start up India”and “Stand up India” announced by Hon’ble Prime Minister are initiatives which offer tremendous opportunities to the women entrepreneurs”, he added. He also said, “Biotech Park is a good example of a Centre and State Government Partnership. The Minister expressed his confidence that with the support of the State Government it will drive many important initiatives under Start up India and Make in India. A large number of Innovation schemes of the S&T Ministry being operated by DST and DBT and initiatives taken by BIRAC have today created a vibrant innovation ecosystem.  More than 1000 Start ups and nearly 200 Women Entrepreneurs have been supported. The Atal Innovation Mission also aims to promote the innovation ecosystem.” “The women scientists would contribute significantly to the growth of the country and fulfill the dream of Hon’ble Prime Minister of “Making a New India”. Women scientists and Entrepreneurs definitely are the Game Changers Driving Science for “Making a New India” Dr. Harshvardhan also released a book – Genesis of Biotech Park – on this occasion. Women Scientists Conclave with the theme “Women Scientist and Entrepreneurs – Game Changers Driving Science for New India” was held as a part of India International Science Congress, 2017 in Chennai.  The theme of the Conclave was to motivate young women to pursue science and entrepreneurship and explore new opportunities. The conclave showcased the strengths and activities of women in science and entrepreneurship and provided a platform for the young women scientist and entrepreneurs to interact with experts and peers. The Conclave is being attended by over 350 Women Scientists, Researchers, Faculty and Entrepreneurs, theme of the Conclave was to motivate young women to pursue science and entrepreneurship and explore new opportunities. Dr. Soumya Swaminathan, Secretary, Department of Health Research (DHR) and Director General, Indian Council of Medical Research (ICMR) delivered the keynote address.   ]]> https://biospectrumindia.com/news/22/9672/india-is-among-the-fastest-growing-medical-tourism-destinations-in-asia-teaotia.html https://biospectrumindia.com/news/22/9672/india-is-among-the-fastest-growing-medical-tourism-destinations-in-asia-teaotia.html Mon, 16 Oct 2017 15:40:00 +0530 The government of India recently, has been proactively pushing the idea of medical tourism. Now since the wheels of this concept have churning rapidly, the government estimates it will reach a US $9 billion mark by 2020, making India the fastest growing medical tourism destinations in Asia. “During the early days of medical tourism, the attention was always given to developed countries,” said Rita Teaotia, Secretary, Ministry of Commerce. “It has now shifted to Asia, and India is among the fastest growing medical tourism destinations in Asia,” she said, addressing the third edition of Advantage Healthcare India 2017 summit, being held by FICCI. Medical tourism, wherein people travel outside their countries for medical treatment, is estimated to be a $3 billion-worth industry. Ayurveda, yoga and wellness industry in India set it apart from other medical tourism destinations in the world, the official said. “Ayurveda has managed to catch the attention of many countries, especially European countries. The government will continue to focus on global acceptance of Ayurveda on the lines of Chinese medicine,” she said. Gaurav Gupta, Principal Secretary of Department of IT, Biotechnology and Tourism for Karnataka, said: “Karnataka, with direct connectivity to world capitals, and 56 medical colleges, and 19 National Accreditation for Hospitals and Healthcare Providers (NABH) accredited hospitals, is soon going to come out with a medical and wellness tourism policy.” India can be a $9 billion-worth medical tourism destination by 2020, Gupta said. According to a recent FICCI report, over 500,000 foreign patients seek treatment in India every year. The international summit on medical tourism is being organised by Ficci, along with the Ministry of Commerce and Industry and its Services Export Promotion Council (SEPC). The three-day summit has over 700 delegates taking part in it from over 50 countries like the US, Russia, Saudi Arabia and United Arab Emirates, among others. Pic- Maps Of India ]]> https://biospectrumindia.com/news/22/9669/aiia-to-get-a-national-launch-by-the-pm.html https://biospectrumindia.com/news/22/9669/aiia-to-get-a-national-launch-by-the-pm.html Mon, 16 Oct 2017 11:40:00 +0530 All India Institute of Ayurveda (AIIA), set up under the Ministry of AYUSH, will be inaugurated by Prime Minister Narendra Modi on October 17. October 17 is marked as the Ayurveda Day. The first Ayurveda Day was celebrated last year. AIIA is the first medical institute under Ministry of AYUSH to hold the coveted status of National Accreditation Board for Hospitals and Healthcare Providers (NABH) accreditation. AIIA will bring in the synergy between traditional wisdom of Ayurveda and modern diagnostic tools and technology, stated Shripad Yesso Naik, Minister of State for AYUSH. The institute has been set up on a total area of 10.015 acres on a budget of Rs 157 crore. Within the short duration of its establishment, AIIA has gained a wide national and international recognition. It has started working to facilitate quality patient care, research and bridging the gaps in the scientific information about quality, safety and efficacy of Ayurveda products and developing benchmarks of Ayurvedic education, research and healthcare. The Ayurvedic Standard Treatment Guidelines developed by the ministry will also be released at the inaugural function. Nearly 1,500 participants from across the country are expected to be a part of the program. ]]> https://biospectrumindia.com/news/22/9666/msf-approaches-delhi-high-court-to-challenge-unmerited-patent-grant-.html https://biospectrumindia.com/news/22/9666/msf-approaches-delhi-high-court-to-challenge-unmerited-patent-grant-.html Fri, 13 Oct 2017 17:10:00 +0530 On August 13 2017, the Indian Patent Office dashed hopes for improved access to an affordable PCV13 when it granted a patent to Pfizer for its PCV 13 product, marketed as Prevnar13, which will expire only in 2026. MSF had challenged Pfizer’s unmerited patent claims on the vaccine in India last year to enable and accelerate the availability of more affordable versions of PCV. Médecins Sans Frontières/Doctors Without Borders India has recently filed a petition before the High Court of Delhi to overturn the patent granted on the pneumococcal conjugate vaccine (PCV) to the US pharmaceutical corporation Pfizer. Globally, pneumonia causes more than a quarter of deaths in children under the age of five – nearly one million young lives lost per year. India carries the world’s highest burden of pneumonia, accounting for nearly 20% of these global infant pneumonia deaths. Dr. Greg Elder, Medical Coordinator, MSF Access Campaign said, “Millions of babies and young kids around the world are left unprotected against pneumonia as many governments cannot afford the high price of PCV set by pharmaceutical corporations. As doctors who have watched far too many children die of pneumonia, we’re not going to back down until we know that all countries can afford this vaccine.” According to the petition filed at the Delhi High Court this week, MSF India has argued that in August 2017, the Delhi Patent Office erroneously granted a patent to Pfizer by disregarding the evidence MSF produced indicating that the pharmaceutical giant’s claim to a patent was spurious. MSF also argued that the mere addition of serotypes to the already established 7-valent vaccine did not involve a technical advancement – it was merely a tactic to preserve Pfizer’s monopoly for many more years. The decision also has broader implications, as it indicates a weakening of India’s strict patentability standards, which results in granting monopolies for minor and trivial improvements of existing medical products and restrict access to affordable medicines. Leena Menghaney, the petitioner who is representing the medical aid organization in court said, “A public health perspective used for scrutinizing pharmaceutical patent applications is an essential bulwark to ensure wider access to essential medicines and vaccines. Examiners in the Indian Patent Office must be aware that the decision they take to grant a patent can directly affect access to life-saving medicines and vaccines in India and across the developing world. MSF is appealing to the court to annul the decision to grant the patent and the patent office to hear the matter afresh.”     The pneumococcal conjugate vaccine (PCV) is currently available from only two pharmaceutical corporations: Pfizer and GlaxoSmithKline (GSK). Unfortunately, this vaccine is priced out of reach of many parents, governments and treatment providers, due to a duopoly market and a lack of sufficient competition from developing country vaccine manufacturers (DCVM). Approximately one-third of the world’s countries have not been able to introduce PCV, largely because of high prices. Those who have introduced the vaccine are struggling with its costs. South Africa spends more than 50% of its vaccination budget on purchasing PCV13 alone and this is set to continue for another decade unless patent barriers are removed to bring in more competition. Yuanqiong Hu, Legal & Policy Advisor, MSF Access Campaign said, “While MSF has initiated the legal process to challenge the patent, the actual revocation of an unmerited patent takes years. Looking at the urgent need for this vaccine, we really hope that the Indian Health Ministry in the meantime consider issuing a government use license, to encourage manufacturers who have been developing more affordable PCV13 vaccines to continue with phase 3 clinical trials and deliver the life-saving vaccine for the immunization program, not just in India but across the world.” ]]> https://biospectrumindia.com/news/22/9664/the-latest-guidelines-on-stem-cell-research-imposes-restrictions-on-stem-cell-banking-to-check-unethical-practices.html https://biospectrumindia.com/news/22/9664/the-latest-guidelines-on-stem-cell-research-imposes-restrictions-on-stem-cell-banking-to-check-unethical-practices.html Fri, 13 Oct 2017 16:55:00 +0530 In a move to check rampant unethical practices, government has imposed restrictions on stem cell banking and its therapeutic use, reports The Economic Times. Treatments arising from the field of stem cell research are expected to be promising for a variety of diseases areas like diabetes, cancer, cardiology, neurology and arthritis. There has been a spurt in translational research using different types of stem cells globally over the last decade, according to the National Guidelines for Stem Cell Research unveiled on Wednesday.  At the same time, the field is witnessing "rampant malpractice" and posing challenges for regulatory authorities worldwide, it stated. This includes unscientific or unethical stem cell therapy that continues to pose a threat to the well-being of patients and other vulnerable individuals suggested the guidelines. "In recent years, stem cell research has made rapid strides raising both hope and hype in the public mind, particularly among patients suffering from incurable diseases. However, research in the field is associated with unique ethical, legal and social concerns that require additional oversight and expertise for efficient scientific and ethical evaluation," stated the guidelines.  According to the document, procurement and banking of stem cells derived from sources like cord tissue, placenta, tooth extracts, dental pulp and menstrual blood are increasingly becoming a commercial activity despite no scientific evidence to substantiate their clinical benefits.  "As of now, only UCB (Umbilical Cord Blood) banking is permitted and licensed by CDSCO. Accordingly, commercial banking of all other biological materials (are) not permitted until further notification," it stated.  The new guidelines also reiterated that stem cell use in patients is investigational at present, with the exception of hematopoietic stem cell reconstitution "for approved indications". Hematopoietic stem cells are stem cells that are usually derived from the bone marrow, peripheral blood or umbilical cord blood.  Any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial "with the intent to advance science and medicine…" the guidelines stated. Accordingly, every use of stem cells in patients outside an approved clinical trial is "unethical and shall be considered malpractice," it added.  "Accordingly, the commercial use of stem cells as elements of therapy is prohibited."  Even hematopoietic stem cell transplantations (HSCT) are only allowed for certain types of leukaemia (a blood cancer), lymphomas (cancer of the immune system and white blood cells), plasma cell disorders, tumors and non-malignant diseases. This differs for adults and children, with children being allowed HSCT for fewer types of cancers and more types of non-malignant diseases.  The guidelines formulated taking into account several new scientific and technical advancements and perceived challenges in stem cell research also outlines areas of research that are prohibited. This includes research related to human germ line gene therapy, where DNA is transferred to reproductive cells to correct disease-causing gene variants passed on to the next generation.  Stem cell research is also prohibited in areas like cloning and transplanting living cells, tissues or organs between different species.  The government aims to prevent exploitation and commoditization of resources through the new guidelines.  ]]> https://biospectrumindia.com/news/22/9665/dubais-1st-ever-ayush-conference-will-be-held-in-india.html https://biospectrumindia.com/news/22/9665/dubais-1st-ever-ayush-conference-will-be-held-in-india.html Fri, 13 Oct 2017 15:50:00 +0530 India is all gearing up to organize Dubai’s first ever AYUSH conference in November. Through this event, Science India Forum plans to spread awareness about the prevention and management of lifestyle diseases through Yoga and Ayurveda. The conference for Ayurveda, Yoga and Naturopathy, Unani, Sidha and Homeopathy (AYUSH) practitioners, policy makers, industrialists, researchers and students is being organised under the patronage of Sheikh Nahayan Mabarak Al Nahayan, Cabinet Member and Minister of Culture and Knowledge Development with the Indian missions in Abu Dhabi and Dubai.  The symposium will have 30 invited talks, 150 oral presentations and 100 posters. As many as six workshops are scheduled on Cupping Therapy, Varma Therapy of Sidha, Herbal product registration, Ayurvedic dietetics, Marma and Ayurveda (healing through stimulating vital points) in the conference to be attended by 1200 delegates from AYUSH systems from more than 20 countries. Policy makers, eminent personalities and experts of AYUSH system from Australia, Canada, the US, Singapore, Malaysia, Germany, Russia, India, Hungry, Sri Lanka will participate. ]]> https://biospectrumindia.com/news/22/9651/icmr-honours-86-indian-scientists.html https://biospectrumindia.com/news/22/9651/icmr-honours-86-indian-scientists.html Thu, 12 Oct 2017 12:35:00 +0530 The Indian Council of Medical Research (ICMR) has recently awarded scientists and researchers for their contribution in the field of biomedical science research. The event saw the participation of Minister of State for Health and Family Welfare Anupriya Patel; Dr. V. K. Paul, member, NITI Aayog; Dr. K. VijayRaghavan, Secretary, Department of Biotechnology; and Vaidya Rajesh Kotecha, Special Secretary, Ministry of AYUSH. The council also released National Guidelines for Stem Cell Research, and ICMR Strategic Plan and Agenda 2030 at the event. The ICMR awards recognise the contributions of Indian biomedical scientists undertaking pioneering work in various fields of health sciences and finding solutions for health problems in the country. Eighty-six awards were presented to meritorious scientists across various categories. In an effort to encourage young researchers to join health research and choose it as preferred career path, a new category, the short-term studentship excellence award, was presented for the first time this year. ]]> https://biospectrumindia.com/news/22/9642/aiims-collaborates-with-mental-health-foundation.html https://biospectrumindia.com/news/22/9642/aiims-collaborates-with-mental-health-foundation.html Wed, 11 Oct 2017 11:45:00 +0530 The All India Institute of Medical Sciences (AIIMS) has tied up with the Mental Health Foundation (India) to start School Health Clubs, an initiative aimed at engaging with students to ensure their mental and emotional well-being in the future. The programme is to be implemented at the national level and is being tested in the Capital. Dr. Nand Kumar from the Department of Psychiatry, AIIMS, stated that the aim is to reach out to 50 schools (private/government) in Delhi and will later go national with the programme. Besides school students, teachers and parents will also be a part of the programme. This free-of-cost programme will try and educate students through videos, theatre and group activities. Doctors say that young adults are seeking help for issues such as anger management, emotional instability, lack of tolerance and reduced attention span among others. According to National Mental Health Survey (2016), 1 in 20 people suffer from depression in India. Depression, anxiety and substance abuse together are called Common Mental Disorders (CMD). CMDs are affected by a wide range of socio-cultural, economic and political factors. Yet when it comes to addressing CMDs, it is often seen in the limited view of clinical diagnosis. ]]> https://biospectrumindia.com/news/22/9638/dr-harshvardhan-releases-book-titled-bridging-the-communication-gap-in-science-technology-.html https://biospectrumindia.com/news/22/9638/dr-harshvardhan-releases-book-titled-bridging-the-communication-gap-in-science-technology-.html Tue, 10 Oct 2017 16:35:00 +0530 Dr Harshvardhan, Minister for Science & Technology, Earth Sciences and Environment, Forests & Climate Change has recently released the book at the CSIR auditorium, New Delhi. While releasing the book he said, “An effective communication strategy is very important to take science to the masses. The book provides a snapshot of existing science communication policy and practice in India across different S&T sectors, and offers solutions to building effective communication. It has contributions from stalwarts in the areas of research, policy, and media across the S&T spectrum in India.” “The volume includes academic, policy and practice-driven papers by scholars, practitioners and bureaucrats who have in many cases formulated or been at the helm of S&T communication strategies in independent India, and who offer innovative and new solutions for improving public communication on science and technology in the country”, he added. The release was followed by a panel discussion on theme, ‘When Science Meets the Public, How Do You Bridge the Gap?’ Prof. Ashutosh Sharma, Secretary, Department of Science and Technology (DST), Dr Girish Sahni, Director General of CSIR, Professor Deepak Kumar, a former professor and historian of science from JNU were present in the panel. Ashutosh Sharma said, “Science communication and journalism are too important to be left either to Scientists or to journalists alone. He announced that the Department will launch an internet TV, 24x7 Science TV channel, and web portal for Science & Technology to reach out and increase science awareness and building the scientific temper amongst common people.  He also talked about the scientific social responsibility. He said that scientists are responsible and accountable to people about what they are doing and how their work affects common men’s lives.”   ]]> https://biospectrumindia.com/news/22/9632/government-to-develop-iisers-into-eminent-institutes.html https://biospectrumindia.com/news/22/9632/government-to-develop-iisers-into-eminent-institutes.html Mon, 09 Oct 2017 15:20:00 +0530 After Indian Institutes of Technology (IITs) and Indian Institutes of Management (IIMs), the central government is aiming to make its relatively new set of institutions, Indian Institutes of Science and Education Research (IISERs), as one of their institutes of eminence. IISERs, which are barely 10-year-old institutions, working mostly in the field of research, have been asked by the ministry to focus on industry partnerships for research and generate funds in collaborative projects. The department of higher education in the ministry that handles IISERs is simultaneously also working on a roadmap to develop them as their trademark institutions. Since the institutions are new, their research output is not as much as the IITs and other institutes of eminence. The ministry, however, is impressed by the progress that these institutions have exhibited in the limited time span and hence wants to develop them further. To streamline focus on research and attract the youth to pursue research projects, the ministry had earlier announced a Rs. 70,000 stipend per month to scholars under the Prime Minister's fellowship scheme. There are seven IISERs in the country. In addition to the five older IISERs at Pune (Maharashtra), Kolkata (West Bengal), Mohali (Punjab), Bhopal (Madhya Pradesh), and Thiruvananthapuram (Kerala), the government has established two new IISERs at Tirupati (Andhra Pradesh) and Berhampur (Odisha) in 2015 and 2016, respectively. ]]> https://biospectrumindia.com/news/22/9627/pm-launches-intensified-mission-indradhanush-in-vadnagar-.html https://biospectrumindia.com/news/22/9627/pm-launches-intensified-mission-indradhanush-in-vadnagar-.html Mon, 09 Oct 2017 10:40:00 +0530 In order to accelerate progress towards the goal of full immunization coverage Prime Minister recently launched the Intensified Mission Indradhanush. It will provide greater focus on urban areas and other pockets of low immunization coverage. The Prime Minister distributed e-tablets to health workers to mark the launch of ImTeCHO which is an innovative mobile phone application to improve performance of ASHAs. He also launched some development works.  Addressing the gathering, he said that “coming back to one's home town and receiving such a warm welcome is special. Whatever I am today is due to the values I have learnt on this soil, among you all in Vadnagar.” Speaking at the function,  J P Nadda, Union Minister of Health and Family Welfare, said that "unwavering support of the Prime Minister has always been a source of great inspiration. He added that improving the health status of the children of the country is amongst the top priorities of the Government. Shri Nadda informed that the four phases of Mission Indradhanush have reached to more than 2.53 crore children and 68 lakh pregnant women with life-saving vaccines including 5.21 lakh children & 1.27 lakh pregnant women in Gujarat." "Through this mission, we have accelerated our progress towards our target of 90% full immunization coverage, he stated. Earlier the increase in full immunization coverage was 1% per year which has increased to 6.7% per year through the first two phases of ‘Mission Indradhanush’, he added.With a sharpened focus on high priority districts and urban areas, under IMI, four consecutive immunization rounds will be conducted for 7 days in 173 districts -- 121 districts and 17 cities in 16 states and 52 districts in 8 north eastern states -- every month between October 2017 and January 2018. Intensified Mission Indradhanush will cover low performing areas in the selected districts and urban areas. These areas have been selected through triangulation of data available under national surveys, Health Management Information System data and World Health Organization concurrent monitoring data. Special attention will be given to unserved/low coverage pockets in sub-centre and urban slums with migratory population. The focus is also on the urban settlements and cities identified under National Urban Health Mission (NUHM). IMI will have inter-ministerial and inter-departmental coordination, action-based review mechanism and intensified monitoring and accountability framework for effective implementation of targeted rapid interventions to improve the routine immunization coverage. IMI is supported by 11 other ministries and departments, such as Ministry of Women and Child Development, Panchayati Raj, Ministry of Urban Development, Ministry of Youth Affairs among others. The convergence of ground level workers of various departments like ASHA, ANMs, Anganwadi workers, Zila preraks under National Urban Livelihood Mission (NULM), self-help groups will be ensured for better coordination and effective implementation of the programme.  He also visited GMERS Medical College, Vadnagar, and unveiled a plaque to mark its dedication and also interacted briefly with students.  The Prime Minister expressed happiness that he had got to inaugurate projects related to the health sector, particularly Intensified Mission Indradhanush. He mentioned how the Government had brought down the prices of stents, and said that the Government is working constantly to make healthcare affordable for the poor.  Mentioning his interaction with students from the medical college, the Prime Minister said that as a society, we require more doctors who can serve the people.   ]]> https://biospectrumindia.com/news/22/9625/chennai-corporation-gets-tb-diagnostic-machines.html https://biospectrumindia.com/news/22/9625/chennai-corporation-gets-tb-diagnostic-machines.html Fri, 06 Oct 2017 14:05:00 +0530 Chennai corporation has procured ten GeneXpert tuberculosis detection machines from National Institute for Research in Tuberculosis (NIRT) as part of the 'Stop TB Partnership' programme. The civic body aims to have one such machine at one urban primary health centre (UPHC) in each zone. GeneXpert machines will make the detection of Mycobacterium tuberculosis, the bacterium that causes TB, more accurate and faster than the commonly used smear test. Five more machines will be procured for five more zones under the corporation. The GenXpert uses a chemical test that works at the molecular level to detect TB bacteria using a sputum sample. Unlike the smear test, the diagnosis takes barely an hour or two. Sputum smear, the usual way of testing TB, is not very accurate and takes two to three weeks for results. Apart from detecting the bacterium, the GeneXpert machine can also detect the resistance of the patient to Rifampicin, the most commonly used drug to treat the illness. In Chennai, an estimated 203 out of 10,000 people are said to have the disease, which was added to the list of notifiable diseases in 2012. TB-DOTS (directly observed treatment, short-course) and treatment for MDR-TB (Multi-Drug Resistant TB) is available at all UPHCs in the city. Last year, in Chennai, the number of individuals tested for TB was 74,782, out of which 7,990 patients were diagnosed with TB. The treatment success rate was 80 per cent. From 2014 to 2016, the corporation was involved in the TB-REACH initiative that enabled relatives in contact with sputum positive patients to undergo screening for the disease.   ]]> https://biospectrumindia.com/news/22/9606/indias-biotech-sector-to-reach-100-bn-by-2025-dr-sudha-nair.html https://biospectrumindia.com/news/22/9606/indias-biotech-sector-to-reach-100-bn-by-2025-dr-sudha-nair.html Thu, 28 Sep 2017 16:25:00 +0530 Biotechnology is going to rule the world in near future and Indian biotech industry is expected to reach 100 billion US dollars by the year 2025 as it has already touched 41.64 billion US dollars currently from 1.1 in 2005, said Dr Sudha Nair, CEO, Biotech Park for Women Society in Chennai. She delivered the keynote address at the sensitisation workshop on ‘Entrepreneurship Development Programme in Bio-Sciences for Women’ organised by the Department of Biotechnology of Sri Padmavati Mahila Visvavidyalayam (SPMVV) Tirupati. The five-day workshop was sponsored by the Department of Biotechnology (DBT), Ministry of Science and Technology, New Delhi. Sudha Nair stated that India is home to the third largest number of tech driven start-ups in the world. India’s potential in biotechnology sector makes it 12th most successful country in the world and third in the Asia Pacific region, she said and added that there were 1,022 biotechnology start-up firms in India. This sector is growing at 10 to 15 per cent and is adding 15-20 per cent workforce every year, Sudha Nair said. She specified that the Indian biotechnology industry holds 2.4 per cent share of the global market. This industry was divided into five major segments. They are bio-pharma, bio-services, bio-agri, bio-industrial and bio-informatics. Among these, bio-pharma sector accounts for largest share of the biotechnology industry with a share of 62 per cent (2015) while the least is bio-informatics with a share of a mere one per cent. She made an appeal to women to make the best use of opportunities provided by the government. Dr Arun Ninawe, scientist and adviser of DBT, explained various funding programmes available under DBT such as biocare, biotech parks and other opportunities for women. The chief guest of the inaugural session of the workshop Prof V Durga Bhavani, V-C of SPMVV emphasised on the need of taking technology to product production by women and expressed happiness for allocation of funds to Rural Women Technology Park and Technology based Incubation (TBI) Centre of the university from DST. ]]> https://biospectrumindia.com/news/22/9603/karnataka-pushes-biotech-investment.html https://biospectrumindia.com/news/22/9603/karnataka-pushes-biotech-investment.html Thu, 28 Sep 2017 11:15:00 +0530 To provide a push to investment in the biotechnology industry, the Karnataka State Cabinet recently approved a new biotechnology policy (version 3.0) for 2017-22. The policy encourages investments in new technology platforms of life sciences for effective multi-disciplinary collaborations. It envisions more streamlined financial incentives and concessions for larger investments. Briefing the media on the Cabinet decisions, Law and Parliamentary Affairs Minister T.B. Jayachandra stated that the aim is to encourage R&D in emerging technology areas, such as synthetic biology, diagnosis and management of rare diseases, anti-microbial resistance, aqua-marine biotechnology, animal biotechnology, bio-manufacturing, and development of affordable medical devices, to foster the bio-economy growth. He also mentioned that as far as startups are concerned, the policy would institute funding mechanisms and mentorship programmes to stimulate innovations that not only aid the development of the bio-economy, but also benefit the society as a whole. In 2015, the State captured 35 per cent (₹44,250 crore) of the total revenue (₹1,26,700 crore) generated by the Biotech Market (in India). With the new policy, the objective is to capture a larger share of the predicted $100 billion (₹6,80,000 crore) bio-economy market in India and the $775 billion (₹50,00,000 crore) worldwide bio-economy market. Minister for IT, BT Priyank Kharge highlighted that with India’s human population expected to reach 1.5 billion by 2030, add to that the billions of animals and the ever-dwindling resources, the need of the hour is to develop new bio and other technological innovations. ]]> https://biospectrumindia.com/news/22/9602/india-and-us-discuss-health-issues-over-a-dialogue.html https://biospectrumindia.com/news/22/9602/india-and-us-discuss-health-issues-over-a-dialogue.html Thu, 28 Sep 2017 11:10:00 +0530 The second India-United States health dialogue ended recently in New Delhi after discussions on communicable and non-communicable diseases, health systems, biomedical research and low-cost innovations, science and health data, food and drug regulations, traditional medicine and access to medicines. The US delegation visited several institutes in New Delhi, Mumbai, and Bengaluru to see collaborations to control and manage HIV/AIDS, tuberculosis, antimicrobial resistance, cancer, acute encephalitis syndrome, mental health, vision and traditional medicine. The dialogue aims to strengthen scientific, regulatory, and health cooperation between the two nations and the global community; highlight priorities and ongoing activities, and exchange information on policies, regulations, research, technologies, programs, activities, and practices. C.K. Mishra, secretary, ministry of health & family welfare stated that it is mutually beneficial for India and the US to continue to engage on health issues, to not only address our health challenges but to also, in the process, contribute to global health objectives and outcomes. The goal is to facilitate the development of new collaborations. ]]> https://biospectrumindia.com/news/22/9591/roche-receives-eu-approval-of-tecentriq.html https://biospectrumindia.com/news/22/9591/roche-receives-eu-approval-of-tecentriq.html Wed, 27 Sep 2017 17:40:00 +0530 Roche has announced that the European Commission (EC) has granted a marketing authorisation for TECENTRIQ (atezolizumab) as a monotherapy for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) after they have been previously treated with chemotherapy regardless of PD-L1 status. People with EGFR-activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving TECENTRIQ. This approval is based on results from the large randomised Phase III OAK study and the randomised Phase II POPLAR study.  The Phase III OAKstudy showed that TECENTRIQ helped people in the overall study population live a median of 13.8 months–4.2 months longer than those treated with docetaxel chemotherapy (median OS: 13.8 vs 9.6 months; hazard ratio [HR] = 0.73, 95% confidence interval [CI]: 0.62, 0.87). The EC has also granted marketing authorisation for TECENTRIQ as a monotherapy for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have been previously treated with a platinum-containing chemotherapy or who are considered ineligible for cisplatin chemotherapy, regardless of PD-L1 status. This approval is based on results from the randomised Phase III IMvigor211 study and cohorts 1 and 2 from the single-arm Phase II IMvigor210 study. The Phase III IMvigor211 study did not meet its primary endpoint of OS, compared with chemotherapy. However, the study showed that the median duration of response (mDOR), a secondary endpoint, for those receiving TECENTRIQ was 21.7 months (95% CI: 13.0, 21.7) in the overall study population, compared with 7.4 months (95% CI: 6.1, 10.3) for those receiving chemotherapy. At the time of data cutoff, the majority (63%) of people who responded to treatment with TECENTRIQ continued to respond, compared with 21% of people treated with chemotherapy. Results from cohort 1 of the Phase II IMvigor210 study showed that TECENTRIQ achieved a median OS of 15.9 months (10.4, NE) in the overall study population. “We are delighted that the European Commission has approved TECENTRIQ, the first anti-PD-L1 cancer immunotherapy approved in the EU, as a monotherapy in both advanced bladder and advanced lung cancer”, said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development in a press release. “The totality of the data for TECENTRIQ across all indications including long-term responses in advanced bladder cancer and the overall survival advantage observed in our phase III advanced lung cancer study means that we are able to extend the benefits of TECENTRIQ to people living with these types of cancer regardless of their levels of PD-L1 expression.” TECENTRIQ is already approved in the USA and in several other countries for people with metastatic NSCLC – and for people with locally advanced or mUC who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy.   ]]> https://biospectrumindia.com/news/22/9581/kerala-prepares-a-roadmap-to-spur-investment-in-the-biotech-sector.html https://biospectrumindia.com/news/22/9581/kerala-prepares-a-roadmap-to-spur-investment-in-the-biotech-sector.html Mon, 25 Sep 2017 18:10:00 +0530 The Government has prepared a roadmap for the creation of an ecosystem to spur investment in the biotechnology sector and facilitate industrial development. The first meeting of the reconstituted Kerala Biotechnology Board (KBB) earlier this month approved several schemes to promote research and entrepreneurship and provide start-up support. The meeting chaired by Chief Minister Pinarayi Vijayan decided to set up a Biotechnology Industry Promotion and Assistance Centre (BIPAC) to extend financial support for industrial research and development programmes under public-private or public partnerships. BIPAC would have a targeted funding mechanism involving a Scheme for Entrepreneurial Promotion, Refining and Industrialization Support (SEPRIS) in the initial stage and a Scheme for One-time Start-up Support (SOSS) in the subsequent phase. Under SEPRIS, entrepreneurs would be given a grant of ₹500,000 for developing proof of concept of their proposed venture, followed by an entrepreneurship development fund up to ₹25 lakh. SOSS, on the other hand, seeks to support start-ups with a seed money assistance up to ₹25 lakh. “BIPAC will be a facility to support the final stage of industrial development which often turns out to be an insurmountable obstacle for many entrepreneurs”, says Prof. G.M. Nair, Advisor, Kerala Biotechnology Commission. “Providing seed money at this juncture is critical for an input-intensive industry like biotechnology which requires heavy investment on equipment in the initial stage,” Prof. Nair said. Principal Secretary, Science and Technology, Mr. Suresh Das said the funding support was designed to minimize the risks associated with commercialization of products. “We have received positive feelers from industrialists willing to invest in the State.” The KBB meeting approved a scheme to foster industry-academia partnership in biotech research. It also decided to launch the Chief Minister’s Career Advancement Programme in Biotechnology to enhance the research capabilities of young faculties and scientists. An industrial training scheme for biotech post graduate students and industry associateship programme for faculty/mid-career scientists to work in industry are other schemes on the anvil, reports The Hindu. “If all goes well, Kerala can hope to gain a foothold in the biotech industry sector within a matter of two to three years,” Prof. Nair said.   ]]> https://biospectrumindia.com/news/22/9579/harsh-vardhan-inaugurates-6th-birac-innovators-meet.html https://biospectrumindia.com/news/22/9579/harsh-vardhan-inaugurates-6th-birac-innovators-meet.html Mon, 25 Sep 2017 11:25:00 +0530 Biotechnology Industry Research Assistance Council (BIRAC), a public sector undertaking of the Department of Biotechnology (DBT) organised a two-day Innovators Conclave and Bio-Innovation Fair at the India Habitat Centre, New Delhi. The theme for the conclave was BIRAC Bio-Innovations: Propelling the Bio-economy, and was inaugurated by Union Minister for Science and Technology and Earth Sciences, Dr. Harsh Vardhan, and attended by Guest of Honour, YS Chowdary, Minister of State (MoS), Science and Technology and Earth Sciences. The Conclave brought together nearly 300 innovators and startups, scientists from industry and academia, public and private sector, policy makers, and national and international organisations. BIRAC has provided financial and mentoring support to more than 500 companies, and nearly 500 young entrepreneurs and startups. BIRAC's partnership network includes more than 15 implementing agencies both national and international, nearly 700 national experts from academia, industry, public and private research laboratories, donor agencies and other government departments that can contribute towards building the innovation ecosystem of India. The conclave was host to a bio-innovation fair and an innovation market place and featured a number of key panel discussions including "The Startup Conversation: Gaps, Opportunities and the way forward" featuring venture capitalists and angel investors and a discussion on "Pathways to create impact through Biotech Innovations to the power of Infinity" featuring decision-makers and experts. "BIRAC has transformed the biotech innovation ecosystem in the country. Our investments in the Indian innovation ecosystem are bearing fruit and our innovations are now showing real impact and producing tangible benefits for society. This Innovation Fair is the perfect occasion for us to showcase what our up and coming investigators are working on and how they hope to transform India. This fair also gives us the opportunity to showcase the potential for scale-up of these innovations to relevant stakeholders and decision-makers," said Dr. Renu Swarup, Senior Advisor, DBT and Managing Director, BIRAC. ]]> https://biospectrumindia.com/news/22/9569/delhi-is-all-set-to-hold-indian-afghanistan-trade-show.html https://biospectrumindia.com/news/22/9569/delhi-is-all-set-to-hold-indian-afghanistan-trade-show.html Thu, 21 Sep 2017 14:15:00 +0530 The national capital of India, New Delhi, is gearing up to hold a 4 day India and Afghanistan trade show from 27-30 September, 2017. This show is facilitated by US in the backdrop of Donald Trump's call to the Modi government to expand socio-economic projects for the Afghans. The show will feature Afghan entities from agriculture, health, education, and energy sectors seeking trade and investment opportunities with India, according to persons familiar with the matter. CEOs from major Indian companies will also be participating, and thematic panel sessions on relevant topics will be held throughout the event. Afghanistan is being assisted by United States Agency for International Development for this trade and investment show aimed at developing stronger India-Afghanistan relations by forging business deals for Afghan products such as produce, spices, carpets and gems and connecting Indian investors with Afghan companies and government entities in the education, healthcare, infrastructure, energy and agricultural sectors. This comes close on the heels of Indo-Afghan decision to launch New Development Partnership involving 116 new High Impact Development Projects that would be jointly implemented in the suburban and rural communities in 31 provinces of the landlocked country. However, USA is not the only P-5 nation that India is engaging to safeguard its interest in Afghanistan. Close on the heels of investment meet Russian Presidential Envoy on Afghanistan Zamir Kabulov will visit Delhi in October to take forward PM Narendra Modi and President Vladimir Putin dialogue in Xiamen on Sep 4 that also focused on Indo-Russian cooperation to stabilise the landlocked country. Russia has revived its interest in Afghanistan since it pulled out from there in 1989 owing to growing network of terror groups in the Eurasian region. India will assist in Shatoot dam and drinking water supply project for Kabul, low-cost housing for returning refugees, water supply network for Charikar city and polyclinic in Mazar-e-Sharif, Gypsum board manufacturing plant in Kabul to promote value-added industry among the slew of projects planned for Afghanistan. This was announced by Foreign Minister Sushma Swaraj after second Indo-Afghan Strategic Partnership Council meeting with her counterpart Salahuddin Rabbani here on Sep 11.   ]]> https://biospectrumindia.com/news/22/9567/revised-cost-norms-for-supplementary-nutrition-provided-in-anganwadis-approved-by-the-cabinet.html https://biospectrumindia.com/news/22/9567/revised-cost-norms-for-supplementary-nutrition-provided-in-anganwadis-approved-by-the-cabinet.html Thu, 21 Sep 2017 11:55:00 +0530 The proposal for revision of cost norms with annual cost indexation for Supplementary Nutrition (SN) for the beneficiaries of Anganwadi Services and Adolescent Girls (out of school 11-14 years) under the Umbrella ICDS Scheme has been approved by the Cabinet Committee on Economic Affairs chaired by the prime minister. In the next three years government is planning to invest an additional Rs 12,000 crore for the nutrition of pregnant and lactating women, children in the age group of 0-6 years, and out of school adolescent girls. The revised supplementary nutrition Cost norms for the beneficiaries of children has been revised to Rs 8 from Rs 6. In case of pregnant women & lactating mothers it has been revised to Rs 9.50 from Rs 7. There is also a revision in cost norms for nutrition provided to severely malnourished from Rs 9 to Rs 12. In case of adolescent girls (11-14 years) it has been revised to Rs 9.50 from Rs 5. This follows the decision by the Government to provide cash benefits to pregnant and lactating mothers under the Pradhan Mantri Matru Vandana Yojana, and is part of an intensive effort to improve the nutritional status of women and children.       ]]> https://biospectrumindia.com/news/22/9566/introduction-of-the-dentists-amendment-bill-2017-approved-by-the-cabinet.html https://biospectrumindia.com/news/22/9566/introduction-of-the-dentists-amendment-bill-2017-approved-by-the-cabinet.html Thu, 21 Sep 2017 11:25:00 +0530 The Union Cabinet has approved the introduction of the Dentists (Amendment) Bill, 2017 in parliament subject to modifications of drafting or consequential nature, if any, as may be considered necessary by the Legislative Department by amending the Dentists Act, 1948 (16 of 1948). The amendment will reduce the redundancy.  As per the existing Act, it was required to have the representation of dentists registered in Part B as Central Government nominees in the Dental Council of India and the election of four/ two members from Part B to the State/ Joint State Dental Councils. In order to reduce the redundancy of the provisions of their representation, the Central Government has decided to delete these provisions so that their representation does not remain mandatory any more. The clauses being amended include those pertaining to certain modifications in the provisions of the Dentists Act, 1948 with regard to: 1) The Membership of the Dental Council of India under clause (f) of   section 3  2) The Membership of State and Joint State Dental Councils under clause (b) of section 21 and clause (b) of section 23 of the said Act.     ]]> https://biospectrumindia.com/news/22/9559/russia-and-india-to-beef-up-their-technologies-for-the-treatment-of-hiv-infection.html https://biospectrumindia.com/news/22/9559/russia-and-india-to-beef-up-their-technologies-for-the-treatment-of-hiv-infection.html Wed, 20 Sep 2017 16:30:00 +0530 The National Immunobiological Company (Nacimbio), part of Rostec state corporation, at Biotechmed conference signed an agreement on the transfer of technology for the production of ready-made dosage forms and active pharmaceutical substances with the Indian pharmaceutical company Mylan Laboratories Limited, part of a global company Mylan NV (USA). Within the framework of the license agreement, there will be a transfer of technology for the production of both ready-made forms and active pharmaceutical substances for the creation of modern combined drugs for the treatment of HIV infection. At “Biotechmed-2017” conference Rostec CEO Sergei Chemezov said that the Corporation's activities are aimed at reducing dependence on imported medicines. At the same time, the corporation is ready for a technological partnership in the pharmaceutical industry. "We are developing our own drug production, jointly with well-known foreign pharmaceutical companies, who are ready to localize production of their products in Russia," said Sergei Chemezov. At “Biotechmed-2017” conference, Nacimbio holding company (part of Rostec State Corporation) signed an agreement on technology transfer with the Indian company Mylan Laboratories Ltd. “We are starting cooperation with India's Mylan Laboratories Ltd. This will provide us with the supply of substances, transfer of technology and the creation of modern combination drugs for HIV treatment. As a result, their cost in the Russian market will significantly decrease,” said Sergey Chemezov. The head of the corporation also noted that in the coming years Nacimbio plans to take a leading position in the production of immunobiological drugs.  Nacimbio supplies domestic vaccines under state contracts with the Ministry of Health, which are included in the national calendar of preventive vaccinations. In total, 17 items of vaccines are supplied, of which 14 are completely Russian-made. The second BIOTECHMED biotechnology conference took place in Gelendzhik, September 14-15, 2017. BIOTECHMED conference was held with the support of the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation and the Ministry of Agriculture of the Russian Federation. The strategic partner of the conference was Rostec State Corporation. ]]> https://biospectrumindia.com/news/22/9557/assam-to-establish-technology-incubation-centre.html https://biospectrumindia.com/news/22/9557/assam-to-establish-technology-incubation-centre.html Wed, 20 Sep 2017 14:55:00 +0530 The Assam government has started a process to set up a technology incubation centre at Guwahati Biotech Park, seeking to promote new businesses in biotechnology and allied areas. The initiative will facilitate faster penetration of biotech industry and accelerate research & development activities in biotechnology and related fields with effective utilisation of the rich natural resources of this region. It will also help educate and utilise local human resources. Assam and the Northeast are rich in natural resources and its biodiversity holds potential to capture the markets of the entire Southeast Asia through concentration in the organic sector. Biotechnological interventions can immensely help Assam in becoming an organic hub. A judicious mix of biotechnological know-how and conventional farming would immensely gear up the agro-based industry in the state. 64 bighas of land have already been earmarked for setting up a permanent campus for the Guwahati Biotech Park at Amingaon. The government has sanctioned Rs 35 crore for the construction of the technology incubation centre and work for it is expected to complete in 2019. ]]> https://biospectrumindia.com/news/22/9556/bihar-initiates-second-phase-of-health-program-.html https://biospectrumindia.com/news/22/9556/bihar-initiates-second-phase-of-health-program-.html Wed, 20 Sep 2017 14:40:00 +0530 Bihar health Minister Mangal Pandey launched the second phase of technical support programme by Bill and Melinda Gates Foundation (BMGF) and CARE India recently. Augmenting the sustained efforts to achieve key health and nutrition outcomes, the state government had signed a memorandum of cooperation with BMGF in 2010. Accordingly, a technical support unit (TSU) was established in the state in 2014. In the first phase of the TSU, it worked closely with the health department and integrated child development services (ICDS) on maternal and child health, family planning and nutrition intervention. The minister stated that despite some positive changes in healthcare scenario in the state, there were many areas that would further be looked into in the second phase of TSU programme. He also stressed on the use of technology to bring efficiency in the health delivery system and connect healthcare workers such as ASHA workers to these technologies. The human resource of healthcare providers in the state needs to be developed. A system is required to train hospital management. Hospital managers have to be guided to maintain standard as required and good public relations with the people who visit the hospital. Supply chain system of medicines and medical equipment also needs to be monitored.   ]]> https://biospectrumindia.com/news/22/9548/government-plans-on-setting-49-new-cancer-centres.html https://biospectrumindia.com/news/22/9548/government-plans-on-setting-49-new-cancer-centres.html Tue, 19 Sep 2017 10:10:00 +0530 With cancer cases on the rise in the country, the government plans to set up 49 cancer centres in the next three years. The centres will be in addition to 31 already functioning and upgraded since 2014-15, when the government floated the scheme. The health ministry has drawn up a detailed project plan which will be reviewed by the Prime Minister’s Office (PMO). According to the proposal, the ministry has estimated a cost of around Rs 3,495 crore to implement the scheme over the next three years. The cancer centres will be set up in a phased manner under the existing National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke. Apart from setting up cancer centres which include construction or upgrade of existing facilities like district hospitals, regional cancer centres and government medical colleges, the government’s programme will also provide support for high-end equipment and advanced technology for cancer treatment. While the 49 new cancer centres will be initially set up under two categories, state cancer institutes and tertiary care cancer centres (TCCCs) in a phased manner, they will be responsible for building capacities of other institutions below for prevention, control, diagnosis and treatment. ]]> https://biospectrumindia.com/news/22/9547/india-and-japan-sign-15-agreements-including-biotech-rd-and-science.html https://biospectrumindia.com/news/22/9547/india-and-japan-sign-15-agreements-including-biotech-rd-and-science.html Mon, 18 Sep 2017 14:00:00 +0530 India and Japan on Wednesday signed 15 deals in key areas, including civil aviation, trade, science and technology, and skill development. The pact in the area of disaster risk management, entered into between the Ministry of Home Affairs and the Cabinet Office of the Government of Japan, aims to cooperate and collaborate in the field of disaster risk reduction, an official statement said. It said the understanding in the field of skill development looks to further strengthen bilateral relations and cooperation in the field of Japanese language education in India. The one titled 'India-Japan Investment Promotion Road Map' envisages enhanced Japanese investments in India while the 'Japan-India special programme for Make In India' is on bilateral cooperation towards infrastructure development in the Mandal Bechraj-Khoraj region in Gujarat. There was an exchange of RoD (Record of Discussions) on civil aviation under which Indian and Japanese carriers can now mount an unlimited number of flights to selected cities in both countries. There was an agreement to establish a joint exchange programme to identify and foster talented young scientists from both countries to collaborate in the field of theoretical biology. The MoU (Memorandum of Understanding) between the Department of Biotechnology and Japan's National Institute of Advanced Science & Technology (AIST) seeks to promote research collaboration between these institutions in the field of life sciences and biotech, the statement said. The India Japan Act East Forum, among the agreements signed, seeks to enhance connectivity and promote developmental projects in India's North Eastern region in an efficient and effective manner, it said. There were four agreements in the field of sports, including one to facilitate and deepen international education cooperation and exchanges between both Sports Authority of India and Nippon Sport Science University, Japan. ]]> https://biospectrumindia.com/news/22/9543/india-and-japan-sign-mou-for-the-expansion-of-biotech-lab.html https://biospectrumindia.com/news/22/9543/india-and-japan-sign-mou-for-the-expansion-of-biotech-lab.html Mon, 18 Sep 2017 12:55:00 +0530 India and Japan has signed an MoU for expansion of an international laboratory set up for a collaborative research inthe area of biotechnology. According to a press release, the pact signed on a day when Japanese Prime Minister Shinzo Abe arrived in India ona two-day trip, envisages the expansion of the laboratory set up by India's Department of Biotechnology (DBT) andJapan's National Institute of Advanced Science and Technology under the name of DAILAB. The Memorandum of Understanding (MoU) is likely to be exchanged after the delegation-level talks between Abe andPrime Minister Narendra Modi. DAILAB is located in Japan. The new centre to come up after the pact will be called DAICENTER. It will seek to enhance the level of joint research, training and networking programmes that had been underwaythrough DAILAB and its six ancillary institutes called Satellite International Institutes for Special Training, Educationand Research (SISTERS) for the past three years. It would also focus on connecting the academia to the industry and network innovation to entrepreneurship promotingscience and technology relationships of the two countries.Department of Biotechnology (DBT) Secretary, K Vijayaraghavan, expressed hope that the expansion of the jointlaboratory would help in pooling the resources of the two countries towards meeting the growing needs. ]]> https://biospectrumindia.com/news/22/9535/india-and-japan-join-hands-for-stem-cell-research.html https://biospectrumindia.com/news/22/9535/india-and-japan-join-hands-for-stem-cell-research.html Thu, 14 Sep 2017 11:05:00 +0530 In the light of Japan’s Prime Minister Shinzo Abe’s visit to India, the two countries have signed a host of agreements to further cooperation in science and technology, including research into stem-cells for making bone-marrow transplants more accessible. The Department of Biotechnology (DBT) already has an India-Japan cooperative programme that has Christian Medical College & Hospital, Vellore, and Kyoto University, Japan, as participants. Though the DBT and Japan’s National Institute of Advanced Industrial Science and Technology (AIST) have been collaborating in these areas, they renewed the agreement for five more years. The aim of the programme is to develop infrastructure and expertise for India to be a competitive force in regenerative medicine and induced pluripotent stem cell biology. The focus of the collaboration is on developing treatments for sickle-cell anaemia, Beta thalassemia and brain disorders, and creating a haplobank relevant to Indian populations. A haplobank refers to a specially maintained collection of embryonic cells that can, in theory, be directed to become any kind of cell and thus progenitor of replacement organs. Japanese scientist Shinya Yamanaka was a co-recipient of the Nobel Prize for medicine for discovering ways to reprogram mature stem cells. ]]> https://biospectrumindia.com/news/22/9530/mou-between-india-and-morocco-in-the-field-of-health-approved-by-the-cabinet.html https://biospectrumindia.com/news/22/9530/mou-between-india-and-morocco-in-the-field-of-health-approved-by-the-cabinet.html Wed, 13 Sep 2017 14:55:00 +0530 The Union Cabinet chaired by the Prime Minister has given its approval for signing of a Memorandum of Understanding (MoU) between India and Morocco on cooperation in the field of health.  The MoU covers the areas of cooperation in Non-communicable diseases, including child cardiovascular diseases and cancer; Drug Regulation and Pharmaceutical quality control; Communicable Diseases; Maternal, child and neonatal health; Hospital twinning for exchange of good practices; Training in administration and management of health services and Hospitals; Any other area of cooperation as may be mutually decided upon.  A Working Group will be set up to further elaborate the details of cooperation and to oversee the implementation of this MoU.  ]]> https://biospectrumindia.com/news/22/9520/centre-gears-up-for-curbing-hepatitis.html https://biospectrumindia.com/news/22/9520/centre-gears-up-for-curbing-hepatitis.html Tue, 12 Sep 2017 10:55:00 +0530 Setting itself a three-year target to eliminate hepatitis, which affects 52 million people in the country, the health ministry is gearing up to roll out a national action plan by October end. Prevalence of hepatitis B is high in tribal areas in India. Chronic Hepatitis B infection accounts for about 30 per cent of liver cirrhosis and 40-50 per cent of liver cancers in India. Outbreaks of acute and fulminant hepatitis B still occur mainly due to inadequately sterilised needles and syringes. Experts say over 90 per cent of Hepatitis C patients can be cured with treatment. However, most people infected with the disease are unaware of it. Apart from making testing and treatment options available at district levels, the action plan will also include testing guidelines and training for healthcare workers. The government will also identify high burden districts under the action plan and put them under greater surveillance. The regional action plan for Hepatitis B and C will focus on five essential components – expanding coverage for Hepatitis B vaccine, blood safety, making treatment options available, prevention from reusable syringes and sanitation and safe water. The health ministry is working with the UN agency to develop the action plan. ]]> https://biospectrumindia.com/news/22/9491/government-launches-new-free-contraceptives.html https://biospectrumindia.com/news/22/9491/government-launches-new-free-contraceptives.html Wed, 06 Sep 2017 11:20:00 +0530 Government has launched two new free contraceptives, an injectable drug and a pill, expanding the basket of choices for the country's population to meet their family planning needs. The contraceptives, which are available for free in medical colleges and district hospitals at present, have so far been launched in ten states- Maharashtra, Uttar Pradesh, Madhya Pradesh, Rajasthan, Karnataka, Haryana, West Bengal, Odisha, Delhi and Goa. The contraceptives are safe and highly effective. The Antara injectable being effective for three months and the Chayya pill for one week, will help meet the changing needs of couples and help women plan and space their pregnancies. The contraceptives are being launched under the government's Mission ParivarVikas, a central family planning initiative. The mission is being implemented in 146 high focus districts that house 44 per cent of the country's population, with the highest total fertility rates in the country. These districts are in the seven states of Uttar Pradesh, Bihar, Madhya Pradesh, Rajasthan, Jharkhand, Chhattisgarh and Assam. Training of healthcare practitioners from all the states has been completed as well, with a pool of state and district level doctors and staff nurses being trained to support the roll-out.   ]]> https://biospectrumindia.com/news/22/9489/healthcare-uk-backs-india-to-create-11-medicities-across-the-country.html https://biospectrumindia.com/news/22/9489/healthcare-uk-backs-india-to-create-11-medicities-across-the-country.html Tue, 05 Sep 2017 16:30:00 +0530 Healthcare UK is backing a massive project in India which will enable the country to develop 11 Mdicities across the nation. The Indo-UK Institute of Health (IUIH) programme is one of the world’s largest healthcare initiatives currently underway. It aims to partner with key NHS providers to transform the provision of quality healthcare and medical education services across India. IUIH’s vision is to provide integrated healthcare across India by partnering with global leaders in research, education, technology, manufacturing and health care delivery. The project led by Dr. Ajay Gupta, Group MD and CEO, IUIH will deliver a staged rollout of healthcare services across 100 cities. It will involve the development of 11 Medicities along with a network of primary care clinics across India. The project is envisaged to take 10 years to complete, with the first phase already underway. Each Medicity will be developed in partnership with a leading NHS Trust under a commercial contract. This commitment by the Indian government and IUIH has already recorded over £150 million in export wins for the UK since 2015 and continues to grow. The scale of this project signifies significant export opportunities for NHS Trusts and other healthcare services providers throughout India. The NHS partner for the first two sites at Nagpur and Amravati respectively is Kings College Hospital (KCH). Healthcare UK was responsible for introducing Dr. Ajay Gupta (IUIH) to KCH. Lord Kerslake, Chairman of Kings College sees the role of KCH as “bringing healthcare expertise and advice to the project”. In the last couple of weeks, high profile foundation stone laying ceremonies have been held at the first 2 Medicity sites at Nagpur and Amravati. This milestone is a major step forward and owes a great deal to 2.5 year’s hard work by Healthcare UK and the Department for International Trade (DIT) India who have provided significant support and guidance to IUIH. ]]> https://biospectrumindia.com/news/22/9479/cabinet-approves-mou-on-india-israel-industrial-rd-and-technological-innovation-fund-.html https://biospectrumindia.com/news/22/9479/cabinet-approves-mou-on-india-israel-industrial-rd-and-technological-innovation-fund-.html Mon, 04 Sep 2017 13:15:00 +0530 The Union Cabinet has recently approved a Memorandum of Understanding (MoU) between India and Israel on "India-Israel Industrial R&D and Technological Innovation Fund (I4F)" which was concluded in July, 2017 India and Israel will make contribution of four million US Dollars each for the fund, both equivalent amount, annually for five years. The Innovation Fund will be governed by a joint Board which will consist of four members from each country. The MoU envisages promotion of bilateral Industrial R&D and Innovation cooperation in the fields of science and technology by extending support to joint projects for innovative or technology-driven new or improved products, services or processes. Such projects will lead to affordable technological innovations in focus areas of mutual interest such as water, agriculture, energy and digital technologies. Institutional support in building up consortia including private industry, enterprises and R&D institutions from India and Israel will be enabled through these collaborative projects. The activities supported by the Joint Fund would increase the techno-economic collaboration between the two countries by investing in jointly developed technology projects and collaborations based on technological innovation. It would leverage the complementary strengths of Israel and India to encourage Israel-Indian joint projects that capitalize on both the national and global marketplace. It would provide a comprehensive set of support tools to encourage joint projects that convert "know-how" into "show-how". It is expected that this will foster and strengthen the eco-system of innovation and techno-entrepreneurship in India and will contribute directly to the Start-up India programme.     ]]> https://biospectrumindia.com/news/22/9469/minister-of-state-health-may-step-down.html https://biospectrumindia.com/news/22/9469/minister-of-state-health-may-step-down.html Fri, 01 Sep 2017 11:10:00 +0530 Ahead of a Cabinet reshuffle by Prime Minister Narendra Modi, several ministers have resigned from their posts. Faggan Singh Kulaste, Minister of State for Health and Family Welfare, has tendered his resignation. It is understood that both Amit Shah and PM Modi were unhappy with the attendance of Kulaste in the ministry. The others who have resigned are Agriculture Minister Radha Mohan Singh and minister of state Sanjeev Balyan. Water Resources Minister Uma Bharti has also reportedly offered to quit on health grounds. Some ministers could lose their jobs over performance. Radha Mohan Singh has faced tremendous flak over the death of protesting farmers in Madhya Pradesh's Mandsaur, where the BJP lost a by-election to the Congress recently. The possibly last major reshuffle before the national election is expected before PM Modi leaves on Sunday for a BRICS summit in China. The reshuffle could also see the entry of Janata Dal-United (JD-U) nominees into the ministry, with the party striking an alliance with the BJP in Bihar recently. ]]> https://biospectrumindia.com/news/22/9462/icmr-to-release-stem-cell-research-guidelines-soon.html https://biospectrumindia.com/news/22/9462/icmr-to-release-stem-cell-research-guidelines-soon.html Thu, 31 Aug 2017 12:55:00 +0530 Indian Council of Medical Research (ICMR) is set to come out with guidelines for stem cell research in two weeks. The guidelines are expected to have a negative list of around 10 items in which research would be prohibited. Besides, outlining areas in which research is permitted, detailed regulatory and technical guidelines would also be laid out. The research wing of ministry of health & family welfare is also going to reduce the time taken for approvals in cord and adult stem cell research. "These two areas would be decentralized at the institutional level to reduce the bureaucratic hurdles. The ethics committee within each institution can look into it and would be required to report to ICMR," said an ICMR official. However, for embryonic stem cell research, the National Apex Committee would scan every proposal. "This is so because we want to know how the embryos are procured, what's the procedure etc. This is the area that is most vulnerable to abuse", added the official. The team of experts are meeting in January-end to finalize the guidelines. In 2002, draft guidelines were issued that ICMR should be the regulatory authority for biological research and a National Apex Committee for cell-based research & therapy should be set up. The latter should be vested with powers to examine scientific, technical, ethical, legal and social issues in all the three types of stem cell.   ]]> https://biospectrumindia.com/news/22/9463/icmr-to-release-stem-cell-research-guidelines-soon.html https://biospectrumindia.com/news/22/9463/icmr-to-release-stem-cell-research-guidelines-soon.html Thu, 31 Aug 2017 12:55:00 +0530 Indian Council of Medical Research (ICMR) is set to come out with guidelines for stem cell research in two weeks. The guidelines are expected to have a negative list of around 10 items in which research would be prohibited. Besides, outlining areas in which research is permitted, detailed regulatory and technical guidelines would also be laid out. The research wing of ministry of health & family welfare is also going to reduce the time taken for approvals in cord and adult stem cell research. "These two areas would be decentralized at the institutional level to reduce the bureaucratic hurdles. The ethics committee within each institution can look into it and would be required to report to ICMR," said an ICMR official. However, for embryonic stem cell research, the National Apex Committee would scan every proposal. "This is so because we want to know how the embryos are procured, what's the procedure etc. This is the area that is most vulnerable to abuse", added the official. The team of experts are meeting in January-end to finalize the guidelines. In 2002, draft guidelines were issued that ICMR should be the regulatory authority for biological research and a National Apex Committee for cell-based research & therapy should be set up. The latter should be vested with powers to examine scientific, technical, ethical, legal and social issues in all the three types of stem cell.   ]]> https://biospectrumindia.com/news/22/9465/icmr-to-release-stem-cell-research-guidelines-soon.html https://biospectrumindia.com/news/22/9465/icmr-to-release-stem-cell-research-guidelines-soon.html Thu, 31 Aug 2017 12:55:00 +0530 Indian Council of Medical Research (ICMR) is set to come out with guidelines for stem cell research in two weeks. The guidelines are expected to have a negative list of around 10 items in which research would be prohibited. Besides, outlining areas in which research is permitted, detailed regulatory and technical guidelines would also be laid out. The research wing of ministry of health & family welfare is also going to reduce the time taken for approvals in cord and adult stem cell research. "These two areas would be decentralized at the institutional level to reduce the bureaucratic hurdles. The ethics committee within each institution can look into it and would be required to report to ICMR," said an ICMR official. However, for embryonic stem cell research, the National Apex Committee would scan every proposal. "This is so because we want to know how the embryos are procured, what's the procedure etc. This is the area that is most vulnerable to abuse", added the official. The team of experts are meeting in January-end to finalize the guidelines. In 2002, draft guidelines were issued that ICMR should be the regulatory authority for biological research and a National Apex Committee for cell-based research & therapy should be set up. The latter should be vested with powers to examine scientific, technical, ethical, legal and social issues in all the three types of stem cell.   ]]> https://biospectrumindia.com/news/22/9466/icmr-to-release-stem-cell-research-guidelines-soon.html https://biospectrumindia.com/news/22/9466/icmr-to-release-stem-cell-research-guidelines-soon.html Thu, 31 Aug 2017 12:55:00 +0530 Indian Council of Medical Research (ICMR) is set to come out with guidelines for stem cell research in two weeks. The guidelines are expected to have a negative list of around 10 items in which research would be prohibited. Besides, outlining areas in which research is permitted, detailed regulatory and technical guidelines would also be laid out. The research wing of ministry of health & family welfare is also going to reduce the time taken for approvals in cord and adult stem cell research. "These two areas would be decentralized at the institutional level to reduce the bureaucratic hurdles. The ethics committee within each institution can look into it and would be required to report to ICMR," said an ICMR official. However, for embryonic stem cell research, the National Apex Committee would scan every proposal. "This is so because we want to know how the embryos are procured, what's the procedure etc. This is the area that is most vulnerable to abuse", added the official. The team of experts are meeting in January-end to finalize the guidelines. In 2002, draft guidelines were issued that ICMR should be the regulatory authority for biological research and a National Apex Committee for cell-based research & therapy should be set up. The latter should be vested with powers to examine scientific, technical, ethical, legal and social issues in all the three types of stem cell.   ]]> https://biospectrumindia.com/news/22/9467/icmr-to-release-stem-cell-research-guidelines-soon.html https://biospectrumindia.com/news/22/9467/icmr-to-release-stem-cell-research-guidelines-soon.html Thu, 31 Aug 2017 12:55:00 +0530 Indian Council of Medical Research (ICMR) is set to come out with guidelines for stem cell research in two weeks. The guidelines are expected to have a negative list of around 10 items in which research would be prohibited. Besides, outlining areas in which research is permitted, detailed regulatory and technical guidelines would also be laid out. The research wing of ministry of health & family welfare is also going to reduce the time taken for approvals in cord and adult stem cell research. "These two areas would be decentralized at the institutional level to reduce the bureaucratic hurdles. The ethics committee within each institution can look into it and would be required to report to ICMR," said an ICMR official. However, for embryonic stem cell research, the National Apex Committee would scan every proposal. "This is so because we want to know how the embryos are procured, what's the procedure etc. This is the area that is most vulnerable to abuse", added the official. The team of experts are meeting in January-end to finalize the guidelines. In 2002, draft guidelines were issued that ICMR should be the regulatory authority for biological research and a National Apex Committee for cell-based research & therapy should be set up. The latter should be vested with powers to examine scientific, technical, ethical, legal and social issues in all the three types of stem cell.   ]]> https://biospectrumindia.com/news/22/9458/cabinet-gives-nod-to-mou-on-india-israel-fund.html https://biospectrumindia.com/news/22/9458/cabinet-gives-nod-to-mou-on-india-israel-fund.html Wed, 30 Aug 2017 17:55:00 +0530 The Union Cabinet chaired by Prime Minister Shri Narendra Modi approved a Memorandum of Understanding (MoU) between India and Israel on "India-Israel Industrial R&D and Technological Innovation Fund (I4F)". The MoU was concluded in July, 2017 India and Israel will make a contribution of four million US Dollars each for the Fund, both equivalent amount, annually for five years. The Innovation Fund will be governed by a joint Board which will consist of four members from each country. The MoU envisages promotion of bilateral Industrial R&D and Innovation cooperation in the fields of science and technology by extending support to joint projects for innovative or technology-driven new or improved products, services or processes. Such projects will lead to affordable technological innovations in focus areas of mutual interest such as water, agriculture, energy and digital technologies. Institutional support in building up consortia including private industry, enterprises and R&D institutions from India and Israel will be enabled through these collaborative projects. The activities supported by the Joint Fund would increase the techno-economic collaboration between the two countries by investing in jointly developed technology projects and collaborations based on technological innovation. It would leverage the complementary strengths of Israel and India to encourage Israel-Indian joint projects that capitalize on both the national and global marketplace. It would provide a comprehensive set of support tools to encourage joint projects that convert "know-how" into "show-how". It is expected that this will foster and strengthen the eco-system of innovation and techno-entrepreneurship in India and will contribute directly to the Start-up India programme. ]]> https://biospectrumindia.com/news/22/9456/fee-hike-for-anda-processing-by-usfda.html https://biospectrumindia.com/news/22/9456/fee-hike-for-anda-processing-by-usfda.html Wed, 30 Aug 2017 11:25:00 +0530 Citing high workload, the US Food and Drug Administration (USFDA) has increased fee for processing Abbreviated New Drug Application (ANDA) by over $ 1 lakh to $ 1.71 lakh for the fiscal year 2018. The hike was made under Generic Drug User Fee Amendments of 2017 (GDUFA II). The fee in FY17 was $ 70,480.  According to a notification on USFDA's website, fee for Drug Master File was reduced to $ 47,829 for 2017-18 from $ 51,140 in the last fiscal. These fees are effective on October 1 2017, and will remain in effect through September 30, 2018.  The move is expected to put pressure on Indian drug-makers selling in the US market. However, the FDA has reduced the inspection fee for overseas Finished Dosage Firms to $ 2,26,087 from previous $ 2,72,646.  Similarly, the inspection fee for overseas API (Active Pharma Ingredient) plant was fixed at $ 60,367 from previous $ 59,234.  The revenue base for GDUFA II is $ 493.6 million versus $ 323 million in the final year of GDUFA I - ANDAs are the primary workload driver of the program. GDUFA I was built on the assumption that FDA would receive 750 ANDAs per year.  ]]> https://biospectrumindia.com/news/22/9452/the-george-institute-for-global-health-organised-roundtable-on-mental-health-of-st-communities.html https://biospectrumindia.com/news/22/9452/the-george-institute-for-global-health-organised-roundtable-on-mental-health-of-st-communities.html Tue, 29 Aug 2017 11:40:00 +0530 With the aim of mainstreaming the dialogue around various aspects of tribal mental health, The George Institute for Global Health India, in partnership with other organisations recently organised a roundtable on “Mental Health of Scheduled Tribes in India”. The roundtable focussed on issues related to lack of data and research in the area of tribal mental health and why is it important to bring in this neglected community into the mainstream. Some of the other topics touched upon during the roundtable were service needs of the tribal community, role of socio-economic development in tribal communities that affect mental health and the need for strengthening the evidence base for bringing in policy changes and practice around mental health in Scheduled Tribe communities. The roundtable also addressed some very pertinent questions on the gaps in research on the overall health and mental health among Scheduled Tribes. Speaking at the roundtable, Dr. Pallab Maulik, Deputy Director, and Head of Research, The George Institute for Global Health India said, “There is lack of information on mental health of Scheduled Tribes in India from the research as well as service delivery perspective. Some of the projects undertaken in India show that there are mental health issues among Scheduled Tribes, but we are not looking at them at all.” “We need to look at bringing the tribal community in to the mainstream discussion about their health, check their needs and develop research accordingly”, he added. Also present at the roundtable Dr. P. Subramaniam, Director, Tribal Research Centre, Department of Tribal Welfare, Government of Tamil Nadu said, “The tribal population is generally isolated and lack the basic medical facilities and there is inadequate health infrastructure. Their overall health status is extremely poor, especially mental health. Currently the Government is working closely with NGOs for conducting mental health awareness camps, however, these need to be conducted more intensively on a regular basis.” “We also need to have a strong national level policy for mental health of Scheduled Tribes in our country”, he added. During the roundtable, Prof. R. Srinivasa Murthy, Professor of Psychiatry(Retd.), NIMHANS, Bangalore said, “We need to have a thorough understanding of the development personality of the tribal population and look closely at the social/ community cohesion and mental health of Individuals. Considering the culturally deep-rooted past of the Scheduled Tribes, we need to bring in a culturally relevant mix of healthcare service delivery to counter metal health issues.” Data from a research conducted by The George Institute for Global Health India, in the West Godavari district of Andhra Pradesh shows that almost 5% population in Scheduled Tribe Areas in the region suffer from common mental disorders like stress, depression, anxiety and suicide risk. The data generated from the Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health Programme, also suggests that the mental disorder burden among tribals in the West Godavari district of Andhra Pradesh are similar to populations in other rural areas in the region. The concept of the SMART Mental Health interventions was to bring in innovative models of healthcare delivery to bridge the gap in service provision and use the power of mobile technology to reach out to remote areas and develop applications which can be used by lay health care workers or primary care doctors with limited mental health training. Stakeholders at the roundtable discussed that data, research and services for mental health need to be vastly improved in the country so that the mental health problems of the community can be addresses in a better and effective manner. The roundtable resulted in key recommendations in form of a report, addressing various issues related to tribal mental health. Identifying research questions subsequently leading to the formation of a task force, Bring in new innovative models of service delivery such as utilizing ASHA workers for preliminary screening and referral, Bring in technology intervention for better screening and decision making and to Bring a culturally relevant model of healthcare delivery are some of the key recommendations given during the roundtable.   ]]> https://biospectrumindia.com/news/22/9446/ficci-suggests-way-forward-through-a-4-pillars-medical-devices-policy.html https://biospectrumindia.com/news/22/9446/ficci-suggests-way-forward-through-a-4-pillars-medical-devices-policy.html Mon, 28 Aug 2017 12:20:00 +0530 FICCI recently hosted Department of Pharmaceuticals’ day long workshop on Draft National Medical Device Policy. It was attended by several other medical device stakeholders and senior Government representatives. FICCI has suggested the Government to adopt a 4 pillar balanced approach while drafting the policy to assure the sustainable growth of this nascent industry. Prioritizing on Universal Health Care Access: FICCI strongly proposed that a careful evaluation based selection be made on manufacturing of certain targeted medical devices that can fit the current Indian manufacturing skills and manufacturing ecosystem, along with prevalence of disease that they address, and that the Government facilitates local manufacturing of them in a targeted manner towards the Make In India Program. FICCI suggested that targeting all complex medical devices for Make In India will neither find success nor will make healthcare cost effective in the country. The current consumption levels of medical devices in India at $3 per capita is far lower than the $50 to $70 per capita consumption of China, Brazil and Russia, thus making Make in India a challenge. Universal Healthcare  Provision, by significantly enlarging India’s healthcare market from its currently abysmal 0.8 beds per 1000 population will expand the supply side market size of medical devices. Focusing on export promotion, rather than purely seeking import substitution: Since it is proven that the world over medical device is a global supply chain, as evidenced by the fact that even China is more than 70% import dependent in this sector, FICCI suggested that the Government focus on building India’s global medical devices export competitiveness without seeking to curb imports. Importing low volumes of high quality and novel medical devices will facilitate market adoption, and scale the Indian market, which will eventually benefit domestic manufacturing to acquire both skill and scale. If this strategy is not adopted, India will have to direct far larger resources towards novel innovation, for which both funds and medical research capability is currently in short supply. Adopting a sub-segmented policy approach for medical devices: FICCI observes that, in the absence of a cogent policy, currently all medical devices are treated the same from a policy standpoint. Since both technology and market adoption vastly varies from such low risk devices as a syringe, I.V. catheter or a blood bag, to high risk – high complexity devices as pacemakers and equipment such as MRI machines,  FICCI urged the Government not be make a blanket un-segmented policy. The policy should acknowledge the sub-segmentation of medical devices into simple engineering and complex engineering, and apply distinct policy treatment, wherever applicable. Facilitating an innovation centric approach: As the medical device is a fast innovation driven industry, it will be of utmost importance for the Government to promote an innovation ecosystem approach. This can be driven by keeping innovative devices outside price control, scaling currently abysmal number of innovation incubators such as School of Biodesign to several such institutes, and launching a fiscal incentive mechanism for attracting top global medtech innovators to India. The workshop witnessed Department of Pharma leading the dialog and discussion under the able Chairmanship of Secretary Jai Priye Prakash. ]]> https://biospectrumindia.com/news/22/9433/health-secretary-chairs-national-review-of-nhm-.html https://biospectrumindia.com/news/22/9433/health-secretary-chairs-national-review-of-nhm-.html Wed, 23 Aug 2017 11:20:00 +0530 National Review of the National Health Mission was recently chaired by C K Mishra, Health Secretary. The meeting was also attended by State Health Secretaries and NHM Mission Directors from States/UTs. C K Mishra emphasised upon the need for innovative approaches to make the facilities at the peripheries work to avoid crowding of tertiary care facilities which impacts the quality of healthcare. Reduction of MMR, IMR, improving immunization and uptake of family planning measures in selected States /UTs, roll out of recent initiatives such as, strengthening sub Centres as Health and Wellness Centres, screening for NCDs, progress in TB elimination, status of preparedness for swine flu, addressing HR challenges, DBT payments, digital payments, rare diseases etc. were some of the issues which were included in the agenda. The Health Secretary asked the States/UTs to take a critical look at problem areas at all layers and resolve them through innovative approaches and new ideas. He stated, “NHM provides unparalleled flexibilities to address healthcare challenges specific to State context and needs. While there has been considerable improvement as reflected in accelerated decline of MMR, U5MR, TFR and reversing the incidence of diseases such as TB, HIV, AIDS and Malaria, areas such as NCD prevention and control requires better response.” “The disease burden on account of NCDs is increasing resulting in substantial economic loss for families and the nation as a whole, he said. He emphasised on strengthening health systems, particularly making SNCUs, FRUs and NBCCs functional with requisite HR and equipment backed by trained team for provisioning of quality services”, he also added. States were urged to focus on labour room protocols for intra partum care, carry out 100% Maternal Death Audit for understanding cause of maternal death and monitoring of inborn and out born deaths of sick newborns separately. He stressed, “Mission Indradhanush is not a programme but a campaign towards increasing immunisation coverage. The states must focus on strengthening routine immunization. There is gap in initiation of early breast feeding which needs to be actively bridged through interventions/programmes such Mothers’ Absolute Affection-MAA. Complementary feeding and its quality are also issues that States need to address.” He also urged the State to utilise the NHM flexibilities to devise new strategies and sharpen existing strategies for last mile approach. He exhorted States to start measuring service delivery and monitoring performance based on a set of deliverables with clear allocation of responsibilities and roles for incentivising and fixing accountability. He urged States to co-opt the private sector as elimination of TB is not possible otherwise. States/UTs actively participated by highlighting problem areas, challenges and providing suggestions thereby serving not only as a forum for inputs for the Health Ministry but also for cross learning across States/UTs. ]]> https://biospectrumindia.com/news/22/9424/access-to-affordable-pneumonia-vaccine-gets-tough.html https://biospectrumindia.com/news/22/9424/access-to-affordable-pneumonia-vaccine-gets-tough.html Tue, 22 Aug 2017 14:20:00 +0530 Hopes for improved access to an affordable pneumococcal conjugate vaccine (PCV) that safeguards both children and adults from pneumonia was dealt a major blow after the Indian patent office granted a patent to the US pharmaceutical corporation Pfizer for its PCV13 product, marketed as Prevnar13. “It’s unfair and unacceptable that almost a million children die each year from pneumonia, even though a life-saving vaccine is available. Children everywhere have a right to be protected from pneumonia, but many governments can’t afford the prices set by Pfizer,” said Dr Prince Mathew, Asia Regional Coordinator for Médecins Sans Frontières or MSF. “We urgently need additional manufacturers to rapidly introduce competition with the aim of lowering vaccine prices.” The granting of this patent would block other manufacturers in India from supplying this vaccine which protects against 13 types of pneumococcal bacteria (PCV-13) to those who need it most. According to Leena Menghaney, South Asia Head for MSF’s Access Campaign, “The method Pfizer is trying to patent is too obvious to deserve a patent under Indian law, and is just a way to guarantee an extended market monopoly for the corporation for many years to come.” In 2016, MSF challenged Pfizer’s unmerited patent claims in India, after the same patent was revoked by the European Patent Office (EPO). The patent is also being legally challenged in South Korea and before the US Patent Trademark Appeal Board. MSF relies heavily on affordable generic medicines to do its medical work around the world: two thirds of its medicines used to treat people with HIV, tuberculosis and malaria are generic medicines made in India. Indian vaccine manufacturers have already announced that they can supply PCV for a much lower price. However, Pfizer’s patent allows it to continue controlling the PCV market in India until 2026, and blocks developing country vaccine manufacturers from supplying a competing version of Pfizer’s PCV. Manufacturers will have to find new routes to develop a non-infringing PCV vaccine which may delay the availability of competing products in the pipeline from Indian producers. Dr. Anas Shorman, a paediatrician working for MSF in Jordan, added, “In our work, we see many children with life-threatening respiratory infections; many deaths could be prevented if more kids were vaccinated with PCV. More than 50 countries have spoken out against high vaccine prices, and children in countries like Indonesia, Jordan and Tunisia simply can’t wait any longer to get access to the life-saving pneumonia vaccine.” The Indian patent office’s decision also has broader implications, as it indicates a weakening of India’s strict patentability standards, which results in granting monopolies for minor and trivial improvements of existing medical products, as allowed in some other countries. Such ever-greening practices will hamper India’s role as ‘pharmacy of the developing world,’ supplying governments and procurers like MSF with affordable medicines and vaccines. Each year, MSF teams vaccinate millions of people, both as outbreak response to diseases such as measles, meningitis, yellow fever and cholera, as well as routine immunisation activities in projects where it provides health care to mothers and children. In 2015 alone, MSF delivered about 5.3 million doses of vaccines and immunological products in more than 30 countries. It has purchased PCV in the past for use in its emergency operations and is scaling up its use of PCV and other vaccines with a particular focus on improving routine immunisation, as well as extending the package of vaccines used in humanitarian emergencies. MSF has vaccinated children caught in emergencies with PCV in Central African Republic, Ethiopia, South Sudan, Syria and Uganda, among others. In 2015, MSF launched its ‘A FAIR SHOT’ campaign to push for pharmaceutical companies Pfizer and GSK to reduce the price of the pneumonia vaccine to $5 per child for all three doses.   ]]> https://biospectrumindia.com/news/22/9422/icmr-invests-into-vaccine-research-in-india.html https://biospectrumindia.com/news/22/9422/icmr-invests-into-vaccine-research-in-india.html Tue, 22 Aug 2017 11:25:00 +0530 The Indian Council of Medical Research (ICMR) has entered into an agreement to collaborate on vaccine research and development with international vaccine development organisation International Vaccine Institute (IVI). Through this partnership, India will commit $5,00,000 (Rs 3.20 crore) annually for a stake in IVI. Under its latest Memorandum of Understanding (MoU), ICMR will be focused on research and development of vaccines combatting various infectious diseases. With regard to ICMR’s latest partnership, vaccine candidates developed in IVI labs could be brought to India and given to one of the companies here for further development. IVI may also facilitate further global testing of vaccine candidates developed in Indian labs by linking developers here with global partners. The partnership is further expected to help with capacity building for clinical trials within India as well. The MoU is also expected to help support companies like Bharat Biotech, which has completed phase I clinical trials of its chikungunya vaccine and has expressed the need for support in conducting phase II and III trials for the candidate. India supplies 60 per cent of the world's vaccines for vaccine-preventable diseases and contributes to 60-80 per cent of the United Nation’s annual vaccine purchases. IVI has partnered with Indian vaccine manufacturers, research institutes, government, and public health agencies on vaccine development, research, and training for over a decade.   ]]> https://biospectrumindia.com/news/22/9417/review-meeting-by-j-p-nadda-on-prevention-and-control-of-vector-borne-diseases.html https://biospectrumindia.com/news/22/9417/review-meeting-by-j-p-nadda-on-prevention-and-control-of-vector-borne-diseases.html Mon, 21 Aug 2017 11:20:00 +0530 In order to review the activities for prevention and control of vector borne diseases (dengue, malaria, chikungunya and swine flu), J.P. Nadda, Union Minister for Health and Family Welfare recently held a high level meeting in the capital. Satyendra Jain, Health Minister, Government of Delhi, Mayors of Delhi, C K Mishra, Union Health Secretary, Dr Soumya Swaminathan, Secretary (DHR), Dr Jagdish Prasad, DGHS, Medical superintendent of the Central Government hospitals in Delhi, senior officials from Union Health Ministry, Government of Delhi, ICMR, NCDC and NVBDCP were also present during the meeting. Stressing on the critical importance of prevention of vector-borne diseases, Nadda stated, “all stakeholders including the Government of Delhi, Municipal Corporations, RWAs, NGOs and the people have an important role to play in prevention of breeding of the vectors that cause these diseases. A strong awareness campaign is very effective for educating people to keep their home and surrounding areas free of water clogging. When people are equipped with proper information, they are capable of preventing such diseases and also seeking timely medical intervention.” He also urged the Health Minister of Delhi to launch a house-to-house IEC campaign for creating widespread awareness. The Mayors of Delhi informed that such a campaign has already started and various forms of media are being used to reach out to people. The minister suggested for a workshop to be organised by the Delhi Government for all concerned agencies and stakeholders to sensitise them on the protocols for prevention and management of vector-borne diseases that normally see a spike during the monsoon season and assured the support of the Union Health Ministry in all efforts of the State government to build their capacity. Highlighting the importance of maintaining adequate quantity of testing kits, drugs etc. at the government hospitals and chemists, he requested the Delhi Government to issue an advisory to all chemists to ensure adequate stock of necessary drugs and suggested for hospitals to ensure that adequate number of isolation wards are available and to ensure that protocols for ventilator management are followed.   ]]> https://biospectrumindia.com/news/22/9414/national-pharma-policy-draft-aims-to-boost-domestic-manufacturing-of-drugs.html https://biospectrumindia.com/news/22/9414/national-pharma-policy-draft-aims-to-boost-domestic-manufacturing-of-drugs.html Fri, 18 Aug 2017 14:45:00 +0530 With the aim to boost domestic manufacturing of drugs, levy cap on trade margin, crackdown on unfair marketing practices and limit 'loan licensing' by pharma companies, the government of India has conscripted National Pharma Policy draft. The new draft policy also focuses on creating a national list of essential medicines with the target of keeping the reachable and reasonable. This step could be marked as the beginning of a new era in Indian pharmaceutical sector. The policy also talks about setting up of a National Pharmaceuticals Pricing Authority (NPPA). The draft also aims to create an environment suitable for research and development. The centre also plans to prescribe rules for branding drugs. Companies will be allowed to put brand names only on fixed-dose combinations. For all other drugs, they will be asked to print only the generic names. DG Shah, Secretary General, Indian Pharmaceutical Alliance told to one of the media channels, "We are trying to form a policy without any database" and said that the industry's concerns will be forwarded to the government.” He said that while the draft policy appears to be envisaging a much wider span of control, some of the steps such as eliminating third-party manufacturing and loan licencing would hit the industry as well as the availability of medicines. “What is the extent of loan licencing in the country and what will be the impact? Preliminary calculations show that one-third of the industry is under loan licencing. If it is phased out how many people would lose employment and how would you ensure availability of these medicines?” “This Policy would significantly contribute to the Ease of Doing Business in the pharmaceutical sector… The ‘Make-in-India’ programme would also get an impetus by the actions,” the draft policy says. The Authority is set to lose its autonomy with increase in interference from the government. While the policy says, “The regulator and the government would be two distinct agencies. The government shall not be the regulator and the regulator shall not be the government,” yet a government-appointed advisory body, with representation from the government, industry, as well as civil society, is being proposed. ]]> https://biospectrumindia.com/news/22/9408/health-ministry-planning-to-waive-off-clinical-trials-for-select-drugs.html https://biospectrumindia.com/news/22/9408/health-ministry-planning-to-waive-off-clinical-trials-for-select-drugs.html Fri, 18 Aug 2017 11:20:00 +0530 In a move to make innovative medicines available for critical diseases like HIV, hepatitis and tuberculosis, the health ministry plans to waive off clinical trials in humans for select drugs which are essential for Indian patients and were approved in developed markets like the US, European Union, Japan, Canada and Australia at least two years ago.  "The recommendations were made by the Ranjit Roy Chowdhary committee some time back. The idea is to take a progressive step in the direction of making essential and innovative medicines available in India at a fast pace," Drugs Controller General of India GN Singh , reported Economic Times. Though such waivers are still approved by the drug regulator on case  to case basis, the ministry now plans to bring in legal provisions under the proposed rules for clinical trials. This will enable the regulator set a standard procedure and criteria for approvals.  The health ministry has sent the proposed rules to the law ministry for vetting. Singh said in some cases the clinical trial waiver may even be extended to cancer drugs but only if they are considered essential for treatment of Indian patients and alternatives are unavailable. Companies, however, will also be required to do post marketing trials and submit data in a specified period after the launch. Initially the proposal was to waive off clinical trials for all drugs which are available in these developed markets for at least two years. However, this was met with objections during deliberations by the Drugs and Technical Advisory Board, which usually takes a call on such matters.  Experts part of the board had said some of these medicines may be effective in patients of other countries but may act differently on Indian patients because of genetic make-up. "Our objective is to ascertain safety and efficacy of the drug in Indian patients...We will still decide on case to case basis and take a call depending on the need and efficacy of the drug," Singh said. ]]> https://biospectrumindia.com/news/22/9405/kings-college-hospital-to-come-up-at-amaravati.html https://biospectrumindia.com/news/22/9405/kings-college-hospital-to-come-up-at-amaravati.html Thu, 17 Aug 2017 15:50:00 +0530 N Chandrababu Naidu, Chief Minister, Andhra Pradesh laid the foundation stone for King’s College Hospital, which is coming up in Amaravati, by Indo-UK Foundation with an estimated cost of  Rs 1,600 crore. “With the project, Amaravati gets its largest investment in the health sector,” said Naidu, adding that the first phase of the hospital would be inaugurated on the occasion of Gandhi Jayanti on October 2.Naidu said that he aspires to make the State a Medical hub. The new capital of Amaravati is going to be the Medical Tourism Hub in near future, he said. Chief Minister announced that yet another 20 medical colleges are coming to the State soon. “Kings is one of the world’s most famous hospitals which has come to Amaravati to headquarter all the future projects of that group in the country,” the Chief Minister said. Naidu said that he aspires to make the State a Medical hub. The new capital of Amaravati is going to be the Medical Tourism Hub in near future, he said. Chief Minister announced that yet another 20 medical colleges are coming to the State soon. “Kings is one of the world’s most famous hospitals which has come to Amaravati to headquarter all the future projects of that group in the country,” the Chief Minister said. “India and United Kingdom had government-to-government agreement for developing 11 Indo-UK Institutes of Health (IUIH) in India by Indo-UK Healthcare Private Limited. It will create over 10,000 job opportunities in the health industry. The first phase of king’s College hospital with nursing school, NHS oncology unit, and liver transplant unit will be ready in the next two months and I want it to be inaugurated on October 2,” Naidu said. Picture Credit- The New Indian Express ]]> https://biospectrumindia.com/news/22/9402/knee-implants-become-more-affordable.html https://biospectrumindia.com/news/22/9402/knee-implants-become-more-affordable.html Thu, 17 Aug 2017 11:35:00 +0530 The Centre has fixed a price range between Rs. 54,000 and Rs. 1.14 lakh for knee implants. Also, the price of specialised implants in cancer and tumour cases has been cut to Rs. 1,13,950 from the current price of Rs. 4 lakh to Rs. 9 lakh. The order also specified that no healthcare institutions such as hospitals, nursing homes and clinics performing orthopaedic surgical procedures shall solicit any patient to purchase knee implants from them in case the patient wishes to procure these from a third party. The National Pharmaceutical Pricing Authority (NPPA) had maintained that the average trade margin on orthopaedic knee implants were found to be as high as 313%. The move is expected to save an estimated Rs. 1,500 crore annually. There are 1.5 crore to 2 crore patients who need knee implants. Each year, 1.2 lakh to 1.5 lakh knee surgeries take place in India. According to the order, the ceiling price will apply to all stocks of knee implants available for sale from the date of publication of the notification. Under the new price regime, the MRP of the most widely used complete knee implant (cobalt-chromium) has been fixed at Rs. 54,720 plus GST, which is a reduction of 65% from the earlier average MRP of Rs. 1,58,324. This knee implant enjoys 80% of the market share. The new MRP of the special metal titanium and oxidised zirconium has been fixed at Rs. 76,600 plus GST, down by 69% from an average rate of Rs. 2,49,251. High flexibility implants will now cost Rs. 56,490 plus GST, a cut of 69% from the average MRP of Rs. 1,81,728. ]]> https://biospectrumindia.com/news/22/9391/the-george-institute-and-icmr-discusses-about-the-future-of-womens-health.html https://biospectrumindia.com/news/22/9391/the-george-institute-and-icmr-discusses-about-the-future-of-womens-health.html Wed, 16 Aug 2017 14:40:00 +0530 With the aim of initiating dialogue around various aspects of women’s health, The George Institute for Global Health along with the Indian Council of Medical Research recently organised a roundtable on “The Future of Women’s Health: Using Data and Research to shape women’s Health Policy and Program”. This roundtable focused on key challenges in the areas of data collection and analysis. Some of the challenges identified were consideration of cost, asking the right questions, establishing mechanisms to collect the right data, finding the right tools to analyse the data, taking the time to analyse and report the data, and strengthening the evidence base for changing policy and practice around women’s health. The roundtable also addressed some very pertinent questions on the reasons for gaps in gender-based research. Speaking at the roundtable, Dr. Vivekanand Jha, Executive Director, The George Institute for Global Health said, “Women’s health research is still very much in its infancy. Women are still purposefully and systematically excluded from clinical research, and there is no appreciation of sex differences. Even when data is collected on both men and women, sex disaggregated analysis is never done, so women’s health conditions are not studied in a nuanced manner.” “Greater focus on women’s health is the need of the hour. There are gender differences in society, economics, and at the work place, besides of course in the family, which contribute to distinct health needs and varying health system uses”, he added. The roundtable brought forth some very important points of discussion such as the need to look at multi-dimensional aspects of women’s health while framing policies and programmes. Also, the discussions threw light on the burden of mortality among women in India due to non-communicable diseases (NCD), which, over the years have emerged as the top killers of women in India – responsible for close to 60% of all deaths among women in 2013. This was a second in a series started by The George Institute for Global Health India, in order to address various issues related to women’s health. The first gathering was held in March last year, where the aim was to collect the views of various stakeholders that can help document gender disparities in awareness, access and quality-of-care, and finding biological, social, cultural and health system related explanations for these disparities. It also aimed at determining how best to improve the health of women and adolescent girls, and at identifying strategies to reshape the women's health agenda through a life course approach including prevention and management of non-communicable diseases and injuries.   ]]> https://biospectrumindia.com/news/22/9386/pms-independence-day-speech-2017-highlights.html https://biospectrumindia.com/news/22/9386/pms-independence-day-speech-2017-highlights.html Tue, 15 Aug 2017 13:00:00 +0530 PM’s Independence Day Speech 2017- Highlights in English The Prime Minster, Shri Narendra Modi today addressed the nation from the ramparts of the Red Fort on the 71th Independence Day. Following are the highlights from his speech: 1. Greetings to my fellow Indians on Independence Day. 2. For the freedom and glory of the country, those who have contributed, those who suffered and sacrificed their lives, I salute all those noble souls, mothers and sisters on behalf of 125 crore people of the country from the ramparts of the Red Fort. 3. We remember the great women and men who worked hard for India's freedom. 4. People of India stand shoulder to shoulder with those affected in the wake of natural disasters in parts of the country & the death of children in the hospital. 5. This is a special year- 75th anniversary of Quit India, 100th anniversary of Champaran Satyagraha, 125th anniversary of Ganesh Utsav. 6. The Quit India Movement was “Bharat Chhodo,” but the call today is “Bharat Jodo.” 7. We have to take the country ahead with the determination of creating a 'New India'. 8. From 1942 to 1947, the country had demonstrated collective strength, in the coming 5 years, we have to take the country forward with the same collective strength, commitment and hard work. 9. In our nation, there is no one big or small...everybody is equal. Together we can bring a positive change in the nation. 10. We have to move forward for making a New India with the collective strength of 125 crore people without any discrimination of small and big people. 11. 1st January 2018 will not be an ordinary day- those born in this century will start turning 18. They are Bhagya Vidhatas of our nation. 12. We have to leave this 'Chalta Hai' attitude. We have to think of 'Badal Sakta Hai'- this attitude will help us as a nation. 13. The country has changed, is changing and can change. We have to move forward with this belief and commitment. 14. Security of the country is our priority. Internal security is our priority. Whether it is our oceans or borders, cyber world or space for all kind of security India is capable to defeat all such inimical forces. 15. Our uniformed forces have achieved the pinnacle of sacrifice in fighting left-wing extremism, terrorism, infiltration and elements disturbing peace. The world had to recognise the strength of India and it clout in the surgical strike. 16. One rank, One Pension policy has boosted the morale of our security forces. 17. Those who have looted the nation and looted the poor are not able to sleep peacefully today. 18. No law was passed for those having Benami property for years. However after the recent passage of the Benami Act, within a short span of time, government has confiscated Benami property worth Rs. 800 crores when these things happen, common men feel that this country is for the honest people. 19. Today, we are celebrating the “festival of honesty”. 20. GST has shown the spirit of cooperative federalism. The nation has come together to support GST & the role of technology has also helped. 21. Today, the poor of the country is joining the main stream and the country is moving torwards the path of progress. 22. Good governance is about speed and simplification of processes. 23. India's stature in the world is rising. The world is with us in fighting the menace of terror. I thank all nations helping us doing so. 24. We have to work for the progress of Jammu and Kashmir. 25. There is no question of being soft of terrorism or terrorists. 26. Neither by bullet: nor by abuses but by hugging we can solve the problem of Kashmir. 27. Our fight against black money and corruption will continue. We are trying to bring transparency through technology. 28. There is no question of being soft on terrorism or terrorists. 29. People would be the driving force behind the establishment, rather than the other way around – Tantra se Lok nahin, Lok se tantra chalega. 30. New India will be the biggest strength of democracy. 31. Nature of job is changing with changing demand and changing technology. 32. We are nurturing our youngsters to be job creators and not job seekers. 33. I want to mention those women who have to suffer due to 'Triple Talaq'- I admire their courage. We are with them in their struggles. 34. India is about Shanti, Ekta and Sadbhavana. Casteism and communalism will not help us. 35. Violence in the name of 'Astha' is not something to be happy about, it will not be accepted in India. 36. The country is being run by peace, unity and harmony. It is our civilisation and culture to take everybody along. 37. We are taking the nation on a new track (of development) and are moving ahead with speed. 38. We are devoting significant attention to eastern India- Bihar, Assam, West Bengal, Odisha, Northeast. These parts have to grow further. 39. Our farmers have worked hard to ensure a Record foodgrain production. 40. Over 5.75 crore farmers have been covererd under Pradhan Mantri Fasal Beema Yojaana. 41. Under Pradhan Mantri Krishi Sinchayee Yojana, 30 projects have been completed while work is on for 50 more projects. 42. Under Pradhan Mantri Kisan Samapada Yojana we are providing handholding to the farmers from availing seeds to accessing the markets for their produce. 43. More than 14000 un-electrified villages have been electrified. 44. 29 crore JanDhan accounts opened. 45. More than 8 crore youth have received loans without any guarantee. 46. We are fighting corruption - for the bright future of India and the wellbeing of our people. 47. Our fight against black money and corruption will continue and move forward and the loot in the country will not be allowed. 48. Our strive for a Corruption Free India has yielded results. 49. Black money worth Rs. 1.25 lakh cror has been unearthed. 50. Over 1.75 lakh fake companies have been shut down. 51. Post GST savings and efficiency in transportation sector has increased. Efficiency has gone up by 30 percent. 52. More money has come to the banks due to demonetization which will give impetus to the economy. 53. Our country has the world’s largest youth population. Today is the era of IT and let’s move ahead on the path of digital transaction. 54. Let us lead from front, promote digital economy and adopt the Bhim App. 55. We have moved from Co-operative Federalism to Competitive Co-operative federalism. 56. It had been said in the old scriptures that if a work is not completed on time, one does not get the desired results. 57. For the Team India it is the right time to commit for a New India. 58. We shall build together an India, where the poor will have concrete houses with water and electricity connection. 59. We will build such an India, where the farmers will have a peaceful sleep without any worry. He will earn double than what he is earning today. 60. Our resolve is to build an India, which provides all the opportunities to the youth and women to fulfil their dreams. 61. Our resolve is to build such an India, free from terrorism, communalism and casteism. 62. We will build together an India, where there will be no place for nepotism and corruption. 63. We will build together such an India, which will be clean, healthy and fulfil the dream of self-rule (Swaraj). 64. We aspire to build a Divya and Bhavya Bharat. ]]> https://biospectrumindia.com/news/22/9371/three-states-selected-by-niti-aayog-for-transformative-change-in-health-and-education-sector.html https://biospectrumindia.com/news/22/9371/three-states-selected-by-niti-aayog-for-transformative-change-in-health-and-education-sector.html Wed, 09 Aug 2017 11:30:00 +0530 NITI Aayog has announced partnership with three states each to radically transform their health and education sectors. While Uttar Pradesh, Assam and Karnataka are selected to improve healthcare delivery and key outcomes in these states, Madhya Pradesh, Odisha and Jharkhand have been selected for support to better learning outcomes. States were called to, first, express intent of collaborating with NITI Aayog to better their Health and Education indices. States then made presentations for each sector which was assessed by a committee comprised of senior members of NITI Aayog and Health and Education ministries. The States highlighted the initiatives undertaken by them thus far, their willingness to accelerate improvement and justified why they should be selected for the institutional support being offered by NITI Aayog.  After thorough technical evaluation, the chosen states have committed to time-bound, governance reforms in both sectors. A Program Management Unit to push for efficiency and efficacy in governance structures and service delivery will now be available in the six chosen States for a period of 30 months. It is expected that these three years of focussed attention and support from the premier think tank will lead to a marked transformation and also provide a model for other States to replicate and adapt.  This three-way partnership between NITI Aayog, State Governments and a knowledge partner for each of the sectors is part of the Sustainable Action for Transforming Human Capital (SATH) initiative of NITI Aayog.  SATH program was launched with a purpose to go beyond ranking states and to handhold them in improving their social sector indicators. SATH is a challenging and ambitious initiative as the baseline of various indicators and parameters of education and health in the States are in public domain. It defines a new dimension for cooperative federalism, where NITI Aayog and its knowledge partner will actively aid implementation of their recommendations, in addition to just policy inputs. ]]> https://biospectrumindia.com/news/22/9362/government-widens-the-reach-of-measles-rubella-mr-vaccination-campaign-.html https://biospectrumindia.com/news/22/9362/government-widens-the-reach-of-measles-rubella-mr-vaccination-campaign-.html Tue, 08 Aug 2017 11:05:00 +0530 With an aim of eliminating measles and control rubella/congenital rubella syndrome (CRS) by 2020, Ministry of Health & Family Welfare has initiated measles-rubella (MR) vaccination campaign in the age group of 9 months to less than 15 years in a phased manner across the nation. The Measles-Rubella campaign is a part of global efforts to reduce illness and deaths due to measles and rubella/CRS in the country. Under this campaign approximately 41 crore children will be vaccinated and is going to be the largest ever vaccination campaign worldwide. All children from 9 months to less than 15 years of age will be given a single shot of Measles-Rubella (MR) vaccination during the campaign. Following the campaign, MR vaccine will become a part of routine immunization and will replace measles vaccine, currently given at 9-12 months and 16-24 months of age of child. The first phase of measles-rubella vaccination campaign has already been successfully completed in five states, namely, Tamil Nadu, Karnataka, Goa, Lakshadweep and Puducherry. More than 3.3 crore children were vaccinated, reaching out to 97% of the intended age group. Minister of Health & Family Welfare along with other ministries, development partners, lions clubs, professional bodies like Indian Association of Paediatrics, Indian Medical Association, Civil Society Organisations etc. are involved for achieving the maximum coverage during campaign.   ]]> https://biospectrumindia.com/news/22/9358/delhi-scientists-to-protest-against-cuts-in-research-funding-on-august-9.html https://biospectrumindia.com/news/22/9358/delhi-scientists-to-protest-against-cuts-in-research-funding-on-august-9.html Sun, 06 Aug 2017 12:30:00 +0530 August 9 will witness science rallies in major cities of India. The motive of the pan-India march will be to do away with unscientific beliefs and to press for increase in funding for research activities. Spearheaded by Breakthrough Science Society (BSS), the gatherings would see the members of scientific community standing in defence of science and scientific attitude in an open and visible manner as done by scientists and science enthusiasts worldwide. Scientists from research institutes across New Delhi will take part in a rally, ‘March for Science’ on August 9 to protest against cuts in research funding. The march will start from Mandi House at 4pm and end at Jantar Mantar. The March for Science movement started globally in April. On Earth Day on April 22, scientists ditched their labs and hit the streets in over 600 cities, in what was dubbed as the largest ever protest by science advocates against US President Donald Trump. “It is an organic thing. We will start the march at 4pm and express our views as we move along”, said Dr. Chetana Sachidanandan, Senior Scientist, Institute of Genomics and Integrative Biology, New Delhi. “We expect around 500-600 people to be a part of this rally”, stated Dr. Vinay Kumar, Zakir Hussain College, Delhi University. ]]> https://biospectrumindia.com/news/22/9357/haryana-and-karnataka-to-have-yoga-and-naturopathy-based-research-institutes.html https://biospectrumindia.com/news/22/9357/haryana-and-karnataka-to-have-yoga-and-naturopathy-based-research-institutes.html Fri, 04 Aug 2017 12:35:00 +0530 The establishment of research institutes in Yoga and Naturopathy in Karnataka and Haryana has been approved by the Union government. An autonomous research council called Central Council for Research in Yoga and Naturopathy (CCRYN) is working under the Ministry of AYUSH as the apex body for research and education in the field of Yoga and Naturopathy. Further, the Governing Body of CCRYN has decided to establish five more research institutes in the country. It was further informed that the CCRYN was running a Central Research Institute of Yoga & Naturopathy at Rohini, Delhi, with 20 bedded hospital of Yoga & Naturopathy. The government has approved establishment of Post Graduate Institutes for Research in Yoga and Naturopathy at Nagmangla (Karnataka) and Jhajjar (Haryana) at a total cost of Rs 59.67 crore and Rs 52.04 crore respectively. ]]> https://biospectrumindia.com/news/22/9338/intensified-mission-indradhanush-to-target-full-immunization-coverage-by-2018-.html https://biospectrumindia.com/news/22/9338/intensified-mission-indradhanush-to-target-full-immunization-coverage-by-2018-.html Tue, 01 Aug 2017 15:40:00 +0530 In order to accelerate the full immunization coverage and provide greater focus on urban areas and other pockets of low immunization coverage, the Ministry of Health and Family Welfare has drawn up an aggressive action plan to achieve the target by 2018. Under the plan, States will conduct Intensified Mission Indradhanush drives for 7 working days from 7th day of every month starting from 7th October 2017 for four consecutive months excluding Sundays, holidays and Routine Immunization days. A total of 118 districts, 17 urban areas and 52 districts of North East states will be targeted under Intensified Mission Indradhanush. Under Intensified Mission Indradhanush, greater focus will be given on urban areas which were one of the gaps of Mission Indradhanush. This will be done through mapping of all underserved population in urban areas and need-based deployment of ANMs for providing vaccination services in these areas. Mobility support to field staff for deployment to such areas in urban as well as rural areas will be provided. Intensive monitoring and strong accountability mechanism is being established at all levels with Cabinet Secretary at national level and the Chief Secretary at state level reviewing the preparations and progress. A distinctive feature of Intensified Mission Indradhanush is that greater focus is being given on convergence with other ministries/departments especially women and child development, panchayati raj, urban development, youth affairs, NCC etc. The convergence of ground level workers of various departments like ASHA, ANMs, Anganwadi workers, Zila preraks under NULM, self-help groups will be crucial for successful implementation of Intensified Mission Indradhanush. Four phases of Mission Indradhanush have been completed in 528 districts across the country. More than 2.47 crore children and around 67 lakh pregnant women have been vaccinated under Mission Indradhanush so far. The first two phases of Mission Indradhanush led to an increase of 6.7% full immunization coverage in 1 year as compared to 1% increase in the past. This increase has been more prominent in rural areas as compared to urban areas.   ]]> https://biospectrumindia.com/news/22/9335/ministry-of-ayush-works-on-developing-new-drugs.html https://biospectrumindia.com/news/22/9335/ministry-of-ayush-works-on-developing-new-drugs.html Tue, 01 Aug 2017 13:05:00 +0530 In a move to popularise Indian traditional medicinal systems, the AYUSH Ministry is working relentlessly to develop several new drugs for the treatment of both communicable and non-communicable diseases on scientific lines. These medicines are being developed by newly constituted Central Research Councils — Central Council for Research in Ayurvedic Sciences (CCRAS), Central Council for Research in Homeopathy (CCRH), Central Council for Research in Unani Medicine (CCRUM), and Central Council for Research in Siddha (CCRS) — which function under the Ministry of AYUSH. CCRAS is developing eight new drugs for treatment of diseases or problems related to old age, bronchial asthma, diabetes mellitus, lymphatic filariasis, ovarian cancer, dengue, wound healing and migraine. The CCRH is developing 12 new drugs for various diseases including dengue, malaria, leishmaniasis and diarrhoea. Similarly, the CCRUM is developing drugs against diseases including vitiligo and essential hypertension through multi-centric randomized controlled trials. The CCRS is developing a drug which has been proved to be effective in curing type-II diabetes. A total of 626 colleges have been opened across the country that are involved in the education of AYUSH healthcare system, out of which — 341 colleges are for Ayurveda, 10 for Siddha, 52 for Unani, 204 focused on Homeopathy and 19 on Naturopathy. The government has received 65 proposals for starting new Ayurveda colleges as on July 26, 2017. Under the National AYUSH Mission (NAM), the government has earmarked Rs 440 crore for upgradation and setting up of new AYUSH hospitals and dispensaries in the current current year. ]]> https://biospectrumindia.com/news/22/9334/nhm-himachal-to-launch-e-health-card-scheme-.html https://biospectrumindia.com/news/22/9334/nhm-himachal-to-launch-e-health-card-scheme-.html Tue, 01 Aug 2017 12:55:00 +0530 In an effort to effectively combat non-communicable diseases (NCDs) in Himachal Pradesh, the state National Health Mission (NHM) will soon launch electronic health cards for all patients at the panchayat level. Besides this unique initiative, a new universal health insurance scheme to provide medical reimbursement up to Rs 30,000 to patients will also be launched on August 2 by Chief Minister Virbhadra Singh. While the e-health card will cover diseases like hypertension, sugar, high blood pressure, heart diseases, etc., the subscribers of universal health insurance scheme will have to pay an annual premium of Rs 365 to get the coverage of up to Rs 30,000. According to a senior NHM official, while schemes like Chief Minister Swasthya Bima Yojna and Rashtriya Swasthya Bima Yojna targeted handicapped, old people and the below poverty line families, there was no healthcare scheme for the non-poor population. The NHM also plans to launch a special measles, mumps, rubella (MMR) campaign and a programme to provide free insulin to diabetic children up to 18 years of age. ]]> https://biospectrumindia.com/news/22/9308/supreme-court-seeks-more-data-from-government-on-cultivation-of-gm-mustard.html https://biospectrumindia.com/news/22/9308/supreme-court-seeks-more-data-from-government-on-cultivation-of-gm-mustard.html Wed, 26 Jul 2017 11:55:00 +0530 The Supreme Court has asked the government to stop itself from starting any project on, or commercial release of genetically modified (GM) mustard. A Bench of Chief Justice of India J.S. Khehar and Justice D.Y. Chandrachud said an order would be passed if it was found that GM mustard affected health and lives for generations. The court agreed with Additional Solicitor-General Tushar Mehta’s suggestion to get more scientific information on GM mustard by July 28 to address the apprehensions raised by the court and petitioner Aruna Rodrigues, represented by advocate Prashant Bhushan, on the after-effects of GM mustard. The court scheduled the case for hearing on July 31. “If nothing happens, if there is no problem, then it is fine. But if there is going to be an impact, we would like to have an injunction in place, by either us or by you,” Chief Justice Khehar told Mr. Mehta. ]]> https://biospectrumindia.com/news/22/9304/after-polio-rotary-districts-pledge-support-to-make-india-tb-free.html https://biospectrumindia.com/news/22/9304/after-polio-rotary-districts-pledge-support-to-make-india-tb-free.html Tue, 25 Jul 2017 12:55:00 +0530 Governors from all Rotary Districts along with the Rotary National TB Control Committee recently met with Ministry of Health and Family Welfare (MoHFW) Officials, U.S. Agency for International Development (USAID) & The Union to pledge scaled up support to TB elimination in India. This would extend the Rotary partnership to fight for a TB-free India beyond the existing 7 Rotary Districts. In order to create awareness about Tuberculosis amongst the Rotarians and the community and to support TB case detection in the country, letter of intent was signed between the Union and Rotary India’s National TB Control Committee on June 08, 2016. Challenge TB is the flagship TB control programme of the United States Agency for International Development (USAID); and is implemented by International Union against Tuberculosis and Lung Disease. Rotary India’s contribution to eliminating polio in India is a well acknowledged story of achievement. The organization has helped India move from having half the world’s polio cases in 2009 to being certified “polio free” in 2014. Now Rotary wants to bring the same energy and commitment to take on another big health challenge and help the Indian government take an aggressive step towards the elimination of TB in our country by 2025. Mr. Arun Kumar Jha, Economic Advisor, Ministry of Health and Family Welfare, Govt. of India, commented, “In the past one year, Rotarians have strengthened our fight against TB. This meeting gives us insight on the ongoing TB initiative carried out by 7 Rotary districts. RNTCP is committed to providing increasing access to quality TB care and diagnosis and we need support from stakeholders like Rotary.” Mr. Chocklingam Bhaskar, Rotary International Director, said, “We are grateful to Rotarians who participated in these activities across the country and thank them for their wholehearted commitment and unstinting support to the campaign to end TB in India by 2025. We need to take the message back to our respective districts to create awareness. We wish to encourage other Rotarians to be a part of our efforts and do again what we did with polio: make India TB-Free.” Dr. Reuben Swamickan, Division Chief (TB and Infectious Diseases) USAID India, said, “Tuberculosis affects large segments of the population driving communities towards poverty. To proactively combat this, we need active intervention and positive engagement from all stakeholders, especially the government, international organisations, and the private sector. A formidable partnership with Rotary India, can impact the scenario significantly and help the country reach its goal of eliminating tuberculosis by 2030. Polio is an example. Rotary has the reach, capacity and attitude to help India towards a TB-free India.” Mr. Y. P Das, Chair, Rotary India National TB Control Committee, said, “Rotary India National TB Control Committee got a direction from the Union as to what rotary and clubs can do to bring about awareness about TB. The first meeting happened in 2016. That was the stepping stone. We have been working in 8 districts on activities on awareness towards a TB-Free India and want to take this to other districts as well. We hope all governors will take this back message to their districts and sensitise the clubs.” Nandita Venkatesan, a TB survivor, said, “My message to other TB patients is to be brave and be determined. Take it as a second chance at life. Besides, when life pushes you over, you ought to push back harder! I am far more comfortable in my skin than before. The country requires your support from organizations like Rotary in this fight against TB.” “I pushed myself to run a marathon and trek while on treatment. Stigma & lack of awareness makes it difficult for patients to fight TB. I am a former Rotary member and I know the power of Rotary’s network. Together we can fight TB and eliminate it from the country.” Saurabh Rane, a TB survivor Dr. Jamie Tonsing, Regional Director, The Union South East Asia Office said, “The vision of the Indian Government towards a TB- Free India requires participation from all stakeholders. Our association with Rotary over the past one and a half year has started reaping results. Today, we have our tool kits, shared experience, and commitment. I believe that nothing can stop us from achieving the goal.” ]]> https://biospectrumindia.com/news/22/9301/karnataka-govt-announces-two-flagship-events.html https://biospectrumindia.com/news/22/9301/karnataka-govt-announces-two-flagship-events.html Tue, 25 Jul 2017 09:40:00 +0530 Karnataka’s two flagship events, BengaluruITE.biz and Bengaluru INDIA BIO for 2017 will be co-located at a single venue in India’s IT Capital of Bengaluru with the focal theme ‘Ideate, Innovate and Invent’. This year also marks 20 years of India’s premierevent dedicated to Information Technology and related sectors. The Department of Information Technology, Biotechnology , Government of Karnataka announced that Karnataka’s two flagship events, the 20th edition of BengaluruITE.biz 2017, and the 17th edition of Bengaluru INDIA BIO 2017, will be held from November 16 to November 18, 2017 at the Bengaluru Palace, Bengaluru. Shri Priyank Kharge, Minister of State for IT, BT and Tourism, Government of Karnataka, who announced the events here in Bengaluru, said, “Karnataka has emerged as the leading tech-hub in the country. The focus last year was 'define next', and we were successful in driving engagement with various technology companies across domains. Discussions with various participants last year helped us understand that companies are looking to emerging technologies to drive innovation. We take our event a step further this year, with focus on "Ideate, Innovate, Invent". Our vision is to drive Karnataka as a thought leader in emerging technologies across verticals - from agriculture to aerospace and more.” The list of participating leaders includes Shri Kris Gopalakrishnan, Co-Founder & Executive Vice Chairman, Infosys Ltd. and Chairman, Vision Group on IT, Government of Karnataka, Dr. Kiran Mazumdar Shaw, CMD, Biocon Limited and ChairpersonKarnataka's Vision Group on Biotechnology, and Shri Krishna Kumar Natarajan, Chairma of Mindtree,and Mr. Gaurav Gupta, IAS, Principal Secretary, Department of IT, BT and S&T, Government of Karnataka. Speaking at the inauguration, Shri Gaurav Gupta, IAS, Principal Secretary, Department of IT, BT and S&T, Government of Karnatakasaid, “While celebrating 20 years of BengaluruITE.biz, we have many esteemed international leaders and global speakers gracing the event. The event offers wider opportunities to leverage and benefit from Information Technology and Biotechnology, display important linkages and synergies”. Mr. ShailenderTyagi Director, STPI speaking on this occasion, he  said “STPI is the proud co-host of Bengaluru ITE.biz since its inception. STPI IT export awards and STPI MSME pavilion will certainly be major highlights of the events”. Ms. SalmaFahim, Director of IT & BT, said “Technology today is ever-evolving. Bengaluru, the IT capital of India is already home to the leaders in the technology industry. Bengaluru also boasts of incubating multiple start-ups addressing the needs of various verticals. The objective of the joint event is to discover game-changing ideas and solutions in Information Technology and Bio-technology.The Curtain Raiser was attended by Industry Captains, Associations, Startups, Investors, Policy Makers, Academia, Research Institutes, MSMEs, Trade Commissioners and the Media. The announcement included an overview of the activities being planned during the BengaluruITE.BIZ and Bengaluru INDIA BIO 2017 Conference & Exhibition. This year the combined exhibition of BengaluruITE.BIZ and Bengaluru INDIA BIO 2017 will attract over 300 exhibitors showcasing products and technologies to over 10000 business visitors. The IT conference will cover topics like Cloud & Big Data, Aerospace & Defense, Telecom, Electronics, Cyber security, AVGC AR & VR, ESDM, GIS, Robotics & AI, Privacy & Piracy and newest fields like Blockchain and IoT and Bio techtech conference on Oncology, Rare Diseases & Orphan Drugs; Proteomics; Big Data & Analytics and IoT. Another highlight of the conference would be BIO-IT covering spectrum of bio informatics genomics diagnostics and medical technologies and more. The Bangalore Tech Exchange will witness India’s leading research institutions like CSIR ICMR,DBT, ICAR, DRDO, ISRO, DAE, IISC, JNCASR showcasing their innovate technologies  that can be commercialized. The finals of Rural IT quiz and Bio quiz will be held concurrently with the event.  Along with prestigious STPI IT Export awards and Bio excellence awards, a new category of Business awards are being introduced.Over 100 young researchers will present their ideas in Bio Tech poster sessions and YESS for startup. ]]> https://biospectrumindia.com/news/22/9288/centre-to-set-up-e-portal-for-regulating-online-sale-of-drugs.html https://biospectrumindia.com/news/22/9288/centre-to-set-up-e-portal-for-regulating-online-sale-of-drugs.html Fri, 21 Jul 2017 12:35:00 +0530 All manufacturers, distributors and retailers, interested in selling drugs and medicines online will have to register themselves on an e-portal to be set up soon by the Centre. This information about the Centre's proposed measure to regulate the online sale of drugs was given by the Maharashtra government to a bench of Chief Justice Manjula Chellur and Justice N M Jamdar. The state government gave the information during hearing by the court a plea of city resident M Patil, highlighting the malady of easy, online availability of medicines with students buying drugs on strength of fake medical prescriptions. The high court had earlier taken serious note of the malady and had asked the government as to what steps it proposed to take to tackle it. Additional government pleader P P Kakade told the court that a public notice had been issued by the Union Ministry of Health and Family Welfare in March this year on the need to plug the gaps in sale of drugs, including their online sale. The petition had raised concerns over the easy availability of drugs and medicines even without a doctor's prescription as stipulated by the Drugs and Cosmetics Act. The Centre in its notice has said medicines included in the Schedule H, H1 and X of the said Act shall be dispensed or sold only on a medical practitioner's prescription. The details of medicines sold or dispensed will be entered in the e-platform and bills will be generated through the system. The details will include the prescribing doctor's registration number and the name and registration number of the chemist and the quantity supplied. ]]> https://biospectrumindia.com/news/22/9281/prime-minister-meets-top-scientific-officials-of-government-of-india-.html https://biospectrumindia.com/news/22/9281/prime-minister-meets-top-scientific-officials-of-government-of-india-.html Wed, 19 Jul 2017 12:15:00 +0530 Narendra Modi, Prime Minister of India recently held a meeting with top scientific officials of the Government of India. Dr. V.K. Saraswat, Member, NITI Aayog; Dr. R. Chidambaram, Principal Scientific Advisor, Government of India; and Secretaries related to scientific departments in the Union Government were part of this meeting. Modi said, “Science, technology and innovation are the keys to progress and prosperity of India. The Government’s priority in the science and technology sector is to apply science to solve our country’s problems.” Giving the example of talent spotting in sports, Modi said that mechanisms should be made to identify the brightest and best science talent among school students. Urging officials to break silos Modi said, “A lot of innovation is happening at the grassroots level. A mechanism should be formed to document and replicate successful innovations at the grassroots level.”  Expressing confidence in the abilities of Indian scientists to rise up to the challenges, and provide solutions to improve the lives of the common man in India, he asked the officials to draw up clear targets to be achieved by 2022, the 75th year of independence.   ]]> https://biospectrumindia.com/news/22/9264/punjab-bags-first-un-agency-backed-innovation-centre.html https://biospectrumindia.com/news/22/9264/punjab-bags-first-un-agency-backed-innovation-centre.html Mon, 17 Jul 2017 14:55:00 +0530 UN agency for intellectual property rights, which has centres in 42 countries, will set up a centre in Chandigarh to promote innovation in the region The World Intellectual Property Organisation (WIPO), Geneva, the United Nations agency for the promotion of intellectual property rights (IPR), has chosen the state’s capital Chandigarh to set up its first Technology Innovation and Support Centre (TISC) in India. WIPO has centres in 42 countries so far, but India was not among them. This first-of-its kind centre will come up at the Patent Information Centre (PIC), Punjab State Council for Science and Technology (PSCST), in Sector 26, Chandigarh. There were several other states, which had set their sights on TISC, but Punjab bagged it because of its proactive work in the field of intellectual rights. Dr Jatinder Kaur Arora, executive director of PSCST, said, “Central government did an onsite evaluation of their work and infrastructure before deciding to select Punjab for TISC.” The PIC has set up 13 IPR cells in various universities of the state, besides starting 16 IPR clubs in engineering colleges and institutes. It has also introduced a helpdesk at Ludhiana. Gurharminder Singh, Senior scientific officer and in-charge of PIC said, “What he found the most heart-warming were the applications for patents from ordinary individuals, and the innovations they brought to the table.” “The new centre will provide a big boost to innovators in the region. They will be able to access international IP facilities, world-class databases, innovations in key industrial sectors, and best practices of other countries,” he says, adding that WIPO teams will come here frequently to train people”, added Dr Arora. “TISC will also target two industry clusters, one of sports in Jalandhar and the other of agriculture and food processing. “We hope to improve their efficiency with patents and innovations available in the public domain”, he added TISC programme provides innovators in developing countries high quality technology information to help them exploit their innovative potential. The agreement for the TISC was signed recently in New Delhi by Dr Roshan Sunkaria, principal secretary, department of science, technology and environment, Punjab.   ]]> https://biospectrumindia.com/news/22/9254/national-strategic-plan-for-malaria-elimination-2017-22-launched-by-j-p-nadda.html https://biospectrumindia.com/news/22/9254/national-strategic-plan-for-malaria-elimination-2017-22-launched-by-j-p-nadda.html Thu, 13 Jul 2017 15:10:00 +0530 J P Nadda, Union Minister of Health and Family Welfare has launched the National Strategic Plan for Malaria Elimination (2017-22) The Strategic Plan gives year wise elimination targets in various parts of the country depending upon the endemicity of malaria in the next 5 years. Speaking at the launch, Nadda said, “The government would like to eliminate malaria by 2027 and urged the states for active cooperation. He further stated that the programme has to be owned by the states” Recalling the launch of the National Framework for Malaria Elimination (NFME) last year, Nadda stated that, “NFME outlined India’s commitment for eliminating malaria by 2030. Today we are here for the launch of the National Strategic Plan for Malaria Elimination (2017-22) which gives strategies for working towards the ultimate goal of elimination of malaria by 2030. The National Strategic Plan is for five years and requested the Programme Officers to work with a strategy and follow the operational guidelines laid down in the National Strategic Plan” The Health Minister further said that encouraging results have been achieved in the North East India and our efforts are now focussed in other states such as Jharkhand, Odisha, Chhattisgarh, Madhya Pradesh and Maharashtra. He further informed that since the past three years focus is on Long Lasting Impregnated Nets (LLINs). The Ministry has distributed 14 million nets and 25 million nets are to be distributed. Highlighting the salient features of the NSP, Nadda stated, “The strategies involve strengthening malaria surveillance, establishing a mechanism for early detection and prevention of outbreaks of malaria, promoting the prevention of malaria by the use of Long Lasting Impregnated Nets (LLINs), effective indoor residual spray and augmenting the manpower and capacities for effective implementation for the next five years.  Intersectoral coordination is the key, we have to work together with the other Ministries and Municipal Corporations to achieve the desired results” Dr Suchaxaya Prakin, acting WHO representative to India said, “Today's development is an important step in the direction of global efforts for elimination of malaria in various countries. She informed that one child dies of malaria every two minutes and the burden is the heaviest in the African region. India has the third highest malaria burden in the world. She stressed on harnessing innovation and research along with monitoring and surveillance, and community participation” ]]> https://biospectrumindia.com/news/22/9252/cabinet-approves-joint-declaration-of-intent-between-india-and-germany-on-cooperation-in-the-field-of-health-.html https://biospectrumindia.com/news/22/9252/cabinet-approves-joint-declaration-of-intent-between-india-and-germany-on-cooperation-in-the-field-of-health-.html Thu, 13 Jul 2017 14:55:00 +0530 The Union Cabinet has given its ex-post facto approval for signing a Joint Declaration of Intent (JDI) between India and Germany on cooperation in the field of Health. The JDI was signed on 1st June, 2017. The JDI covers the following areas of cooperation in postgraduate education, training of medical personnel, pharmaceuticals and pharmacoeconomics and health economics. A Working Group will be set up to further elaborate the details of cooperation and to oversee the implementation of this JDI. ]]> https://biospectrumindia.com/news/22/9231/credihealth-launches-medical-loan-facility.html https://biospectrumindia.com/news/22/9231/credihealth-launches-medical-loan-facility.html Tue, 11 Jul 2017 15:55:00 +0530 Credihealth, a medical assistance company, has launched a medical loan facility on its platform, partnering with banks, Non banking financial companies (NBFCs) and fintech players like Rubique. Users can now apply for medical loans via Credihealth and make paperless in-principal transactions to avail loans ranging from Rs 30,000 to Rs 50 lakh for a tenure starting from six months to 48 months. The tie-up gives it access to Rubique’s technology platform, network of over 65 financial institution tie-ups, and strong distribution across 29 cities. Credihealth expects reaching out to a much larger audience with its unique healthcare proposition through the partnership and will also benefit from fulfilment support enabled through Rubique’s fulfilment centres. For its future tie-ups as well, it is focused on teaming up with only those financial services players who are highly transparent and give loans at attractive and fair rates. As a one-stop-shop for medical loan sanctions, Credihealth will forward the loan application to all the banks and NBFCs for the necessary approvals as part of this new service. ]]> https://biospectrumindia.com/news/22/9216/4th-national-summit-on-good-replicable-practices-and-innovations-in-public-health-care-systems-conducted-by-health-ministry.html https://biospectrumindia.com/news/22/9216/4th-national-summit-on-good-replicable-practices-and-innovations-in-public-health-care-systems-conducted-by-health-ministry.html Fri, 07 Jul 2017 13:30:00 +0530 4th National Summit on Good, Replicable Practices and Innovations in Public Health Care Systems was recently inaugurated by Sumitra Mahajan, Speaker of the 16th Lok Sabha at Indore, Madhya Pradesh. Faggan Singh Kulaste, Minister of State for Health and Family Welfare, Anupriya Patel, Ministers of State for Health and Family Welfare and Rustam Singh, Health Minister (MP) also graced the occasion.  While highlighting the importance of hospital management Sumitra Mahajan said, “We are taking various steps to ensure that we are meeting Sustainable Development Goals (SDGs). National Health Policy, 2017 is a landmark step as it commits to comprehensive primary healthcare, effective regulatory framework and best infrastructure” Faggan Singh Kulaste urged all the states to learn from the effective endeavours of the other States to address the challenges in healthcare delivery. He said, “This summit is a good platform to share experiences and collectively strategize on how to improve health services in the country” Addressing the gathering, Anupriya Patel said, “The summit gives a unique platform to share those steps that have helped to make a difference in healthcare delivery. These are also helpful in drawing up a roadmap for meeting goals of SDGs and National Health Policy, 2017 which speaks about a comprehensive healthcare delivery framework. If states can weave in the social determinants into module of healthcare provisioning then we can grow and strengthen our healthcare system together” Rustam Singh highlighted various people-centered innovative approaches taken by state to ensure effective healthcare delivery.  C K Mishra, Secretary (Health) emphasised on the need of sharing best practices in healthcare systems as it gives states an opportunity to learn from each other. “We are meeting in the backdrop of two important events. One, shifting of goals from Millennium Development Goals (MDGs) to Sustainable Development Goals (SDGs) and the other is announcement of National Health Policy, 2017. The summit will guide us towards meeting goals set by both,” Shri Mishra said. He further stated that it is important to innovate to meet the targets. The Secretary further added that many exemplary practices have been undertaken in many states to meet healthcare goals and the centre stands committed to supporting the state/ UTs in their innovative endeavours”, he added He also urged the states to align their goals to national and global targets in healthcare delivery. Dr Saumya Swaminathan, Secretary (DHR) and DG (ICMR) highlighted the importance of research in healthcare.  Awards were also given by the health ministry to the states on the basis of Health Indicators and Service Delivery. The award for best performing states in the category of indoor services (based on change of IPD/1000 population from 2015-16 to 2016-17-HMIS) was given to Andhra Pradesh, Rajasthan and Gujarat. Daman and Diu got the award among the Union Territories (UTs). For the best out-patient services, the award was given to Gujarat, Punjab and Jharkhand whereas Dadra and Nagar Haveli got the award amongst the Union Territories. For, average out of pocket expenditure per delivery in public health facility, the award was given to Madhya Pradesh, Jharkhand and Chhattisgarh. Among the UTs, the award was given to Dadra and Nagar Haveli. The award for decline in IMR was given to Jammu and Kashmir and West Bengal among the bigger states, Manipur received it amongst the smaller states and Puducherry amongst the UTs. Best Performance in Revised National TB Control Programmme was given to Assam and Himachal Pradesh.  ]]> https://biospectrumindia.com/news/22/9215/india-declared-itself-free-from-highly-pathogenic-avian-influenza-h5n1-and-h5n8-.html https://biospectrumindia.com/news/22/9215/india-declared-itself-free-from-highly-pathogenic-avian-influenza-h5n1-and-h5n8-.html Fri, 07 Jul 2017 12:30:00 +0530 India has declared itself free from Avian Influenza (Bird Flu) and notified it to the World Organisation for Animal Health (OIE) from 6th June, 2017 and notified the same to OIE According to the statement given by ministry of agriculture, “All the outbreaks of Avian Influenza (HPAI) mentioned above were notified to OIE and the control and containment operations were carried out as per the Action Plan on Preparedness, Control and Containment of Avian Influenza”  Surveillance was carried out throughout the country and around the areas of the outbreaks since completion of the operation (including culling, disinfection and clean-up) and surveillance in the states showed no evidence of presence of Avian Influenza Virus. ]]> https://biospectrumindia.com/news/22/9209/cancon-to-set-consensus-guidelines-for-advanced-head-and-neck-cancer-management.html https://biospectrumindia.com/news/22/9209/cancon-to-set-consensus-guidelines-for-advanced-head-and-neck-cancer-management.html Thu, 06 Jul 2017 17:25:00 +0530 The Head and Neck Oncologists at Cytecare Cancer Hospital in association with The Foundation for Head and Neck Oncology, Association of Otolaryngologists of India & Bangalore Chapter and Association of Oral and Maxillofacial Surgeons of India & Karnataka State Chapter, inaugurated first of its kind Annual Symposium in India on “Consensus Guidelines for Management of Advanced Head and Neck Cancer in India”. Speaking at the occasion, Dr.Vikram D Kekatpure, Sr. Consultant, Head and Neck Surgical Oncology, Cytecare Cancer Hospital, said “Majority of Head & Neck Cancer is reported in advanced stages in India. There is no consensus management of these tumours, there by affecting the outcomes. This symposium will deliberate on available evidence debate, controversies and propose guidelines to improve both functional and oncological outcomes for our patients”. Head & Neck Cancer is one of the most common Cancer in India related to Tobacco menace  with high burden of about half a million new cases each year. Majority of the patient’s seek medical attention in advanced stages, when the functional and Oncological outcomes are compromised. The main objective of this symposium was to develop India specific guidelines for management of advanced Head & Neck cancers. A multidisciplinary team of leaders in Head & Neck Surgery, Medical Oncology, Radiation Oncology, Endocrinology, palliative care deliberated on current evidence; discussed controversies, surgical and radiotherapy techniques and chemotherapy regimen to develop India specific protocols to improve the outcomes.  Addressing the gathering, Dr.Anil D'cruz, Director, Tata Memorial Hospital, Mumbai, said, "CANCON is a well conceptualized program with leaders in field of head and neck oncology, debating on continuous issues pertaining to the treatment guidelines for advanced head and neck cancers in India. The highlight of two day cancer conclave is to conclude consensus statement at the end of each issue".  Advanced trainees and practicing surgeons and physicians in the fields of Head and Neck Surgery, Otolaryngology, maxillofacial and General Surgery, Surgical, Radiation and medical oncology and pain and palliative medicine with interest in Head and Neck oncology participated in the event. The symposium provided an academic impetus to the participants through CME (Continuing Medical Education) and CDE (Continuing Dental Education) Credit Points. ]]> https://biospectrumindia.com/news/22/9203/j-p-nadda-chairs-review-meeting-on-control-of-vector-borne-diseases-.html https://biospectrumindia.com/news/22/9203/j-p-nadda-chairs-review-meeting-on-control-of-vector-borne-diseases-.html Wed, 05 Jul 2017 13:15:00 +0530 In order to review the preparedness of the Ministry for prevention and control of vector borne diseases (dengue, malaria, chikungunya) in the country, J P Nadda, Union Minister for Health and Family Welfare recently held a high level meeting. He asked the states for mounting aggressive IEC campaigns to enhance awareness on prevention and control of vectors in their surrounding areas and neighbourhoods.  C K Mishra, Secretary (Health), Dr Saumya Swaminathan, Secretary (DHR) and DG (ICMR), Dr. (Prof) Jagdish Prasad, DGHS and other senior officers of the Union Health Ministry, National Vector-Borne Disease Control Programme (NVBDCP), National Centre for Disease Control (NCDC) were also present in the meeting along with Directors/ MS from the Central Government hospitals.  Taking stock of the situation, health minister was briefed on the preparations of the health ministry and was informed that technical guidelines for prevention and control and clinical management were developed and shared with the states for implementation. He was further informed that the ministry has requested the States/UTs to declare Dengue as notifiable disease for improving reporting and for taking preventive measures in the affected areas. Nadda stated, “The Union Health Ministry has already provided all logistical and technical support to the States including Delhi in terms of surveillance and diagnostic kits to strengthen their efforts in addressing Dengue and chikungunya.” Noting that community participation and empowerment are the most crucial areas in prevention, he urged all the stakeholders to start rigorous awareness campaigns regarding the preventive steps to be taken by the people in their communities. He directed the officers to conduct regular supervisory visits to the states and various hospitals for assessing the situation, preparedness and to provide on the spot technical guidance to the health authorities.   ]]> https://biospectrumindia.com/news/22/9198/sctimst-signs-mou-with-sitra-for-biomedical-devices.html https://biospectrumindia.com/news/22/9198/sctimst-signs-mou-with-sitra-for-biomedical-devices.html Tue, 04 Jul 2017 16:15:00 +0530 Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum has signed a memorandum of understanding (MoU) with The South India Textile Research Institute (SITRA) for development of medical textiles for biomedical devices. The MoU was signed on 1st July 2017 during TEXTILES India 2017, a mega event conducted by the Ministry of Textiles, Government of India. The event was conducted at Gandhinagar, Gujarat. Signing of MoU between SCTIMST represented by the Director Prof. Asha Kishore and The South India Textile Research Institute (SITRA) represented by the Director Dr.Prakash Vasudevan.   ]]> https://biospectrumindia.com/news/22/9196/govt-extends-tenure-of-prof-k-vijayraghavan-.html https://biospectrumindia.com/news/22/9196/govt-extends-tenure-of-prof-k-vijayraghavan-.html Tue, 04 Jul 2017 15:05:00 +0530 The Appointments Committee of the Cabinet (ACC) has approved the extension in tenure of Prof K VijayRaghavan, Secretary, Department of Biotechnology (DBT) till February 2, 2018, till he attains the age of 64 years. Professor Krishnaswamy VijayRaghavan assumed charge as the Secretary of the Department of Biotechnology in January 2013. He was instrumental in the establishment of the National Centre for Biological Sciences, and steered it as its Director between 1997 and 2013. He is a fellow of the Indian National Science Academy, the Indian Academy of Sciences and the National Academy of Sciences of India. A fellow of the Royal Society (London), and an Associate Member of the EMBO, he was conferred the Padma Shri on January 26, 2013 and in April 2014 he was elected a Foreign Associate of the US National Academy of Sciences. An alumnus of the Indian Institute of Technology, Kanpur and the Tata Institute of Fundamental Research, he continued his post-doctoral work in the California Institute of Technology. Professor VijayRaghavan’s research primarily focuses on how neural- and muscle- circuits are made. ]]> https://biospectrumindia.com/news/22/9186/innovate-in-india-i3-programme-launched-by-the-government.html https://biospectrumindia.com/news/22/9186/innovate-in-india-i3-programme-launched-by-the-government.html Mon, 03 Jul 2017 13:20:00 +0530 With an aim of creating a globally competitive biopharmaceutical industry that can addresses the country’s major concerns around barriers to affordable healthcare; innovate in India (i3) programme was recently launched by Dr Harsh Vardhan, Union Minister for Science & Technology , Earth Sciences, Environment, Forest & Climate Change in New Delhi. The $250 million programme of the Department of Biotechnology (DBT), Ministry of Science & Technology, is a first- of-its-kind mission that brings together industry and academia to promote entrepreneurship and indigenous manufacturing in the biopharmaceutical sector. This flagship programme of the GOI in collaboration with World Bank, will be implemented by Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Enterprise, set up by DBT. Dr Harsh Vardhan stated “This Mission is anticipated to be a game changer for the Indian Bio-pharmaceutical industry. It aspires to create an enabling ecosystem to promote entrepreneurship and indigenous manufacturing in the sector”. Expanding on the scope of the programme Dr K. VijayRaghavan, Secretary, Department of Biotechnology & Chairman BIRAC shared, that “This endeavor will help nurture next- generation technical skills; promote entrepreneurship; and support institutions in adoption of global innovations, technologies, and licensing models. It will provide young entrepreneurs the confidence as well as the systemic support to pursue their aspirations in biotechnological innovation, and transform India into a global hub for cutting-edge biotechnology research and development”. With an aim to provide a level playing field for new entrants, the programme would open calls for research proposals beginning August and roll-out in October this year. Speaking at the occasion, Dr Renu Swarup, Senior Adviser DBT & MD, BIRAC shared, “We undertook an extensive landscaping study to identify critical gaps impeding growth and innovation in the Biopharma sector. Taking cognizance of these gaps, i3 is focussed on targeted measures to develop platform technologies for product validation, link disparate institutions to strengthen clinical trial networks, promote partial de-risking  for novel products, and build capacities in emerging areas such as translational bioinformatics, bioethics etc.” The Mission was launched in the presence of Dr K. VijayRaghavan; Junaid Ahmad, Country Director, World Bank India; dignitaries from the concerned Ministries: Dr Soumya Swaminathan, DG- ICMR; Dr  J.P Prakash; Secretary Department of Pharmaceuticals, Dr GN Singh DCGI and DBT officials.     ]]> https://biospectrumindia.com/news/22/9183/it-is-time-for-india-to-capitalize-now-on-our-unique-strengths-dr-harshvardhan.html https://biospectrumindia.com/news/22/9183/it-is-time-for-india-to-capitalize-now-on-our-unique-strengths-dr-harshvardhan.html Mon, 03 Jul 2017 12:45:00 +0530 “It is time for India to capitalize now on our unique strengths and overcome any hurdles to ensure success in the bio-pharmaceutical market.” This was stated by the Union Minister for Science & Technology and Earth Sciences, Environment, Forests & Climate Change, Dr Harshvardhan while addressing the media in New Delhi on June 30.  The first ever Industry-Academia mission to accelerate biopharmaceutical development in India has been approved by the Government of India. The programme named Innovate in India (i3) will witness an investment of $ 250 million with $ 125 million as a loan from World Bank and aspires to create an enabling ecosystem to promote entrepreneurship and indigenous manufacturing in the sector.  This Mission of the Department of Biotechnology (DBT), Ministry of Science & Technology will be implemented by Biotechnology Industry Research Assistance Council (BIRAC) - a Public Sector Undertaking of DBT. The programme will specifically focus on the development of new vaccines, bio-therapeutics, diagnostics and medical devices to better address the rising burden of diseases in the country. It will also bring isolated centres of excellence together, enhance regional capabilities and strengthen the current bio-clusters network in terms of capacities as well as quantity and quality of output. The programme will help deliver 6-10 new products in the next five years, create several dedicated facilities for next-generation skills, and hundreds of jobs in the process. It will provide young entrepreneurs the confidence as well as the systemic support to pursue their aspirations in biotechnological innovation, and transform India into a global hub for cutting-edge biotechnology research and development.  As a flagship programme of the Government of India in collaboration with World Bank, it promises to boost the growth curve for domestic biopharma in India by accelerating the translation of research concepts into viable products, supporting clinical validation, enabling sustainable networks for collaboration between industry and academia, and supporting entrepreneurial ecosystem amongst many others. Currently India has only 2.8% share in the global biopharmaceutical market, the program would elevate this to 5% resulting in an additional business opportunity of $ 16 billion.  The oversight to the programme would be provided by the Inter-Ministerial Steering Committee comprising of members from various Ministries; and would be supported by Programme Technical Advisory Group comprising of global and national leaders from industry and academia. The programme thereby stands unique in its approach with involvement of global experts, industry leaders and World Bank in driving it and ensuring world class biomedical products are born out of the initiative. This Mission is anticipated to be a game changer for the Indian Biopharmaceutical industry.  ]]> https://biospectrumindia.com/news/22/9179/govt-approves-amendments-in-legal-metrology-packaged-commodities-rules-2011-.html https://biospectrumindia.com/news/22/9179/govt-approves-amendments-in-legal-metrology-packaged-commodities-rules-2011-.html Fri, 30 Jun 2017 17:50:00 +0530 The Union Food and Consumer Affairs Minister Ram Vilas Paswan has approved amendments to the Legal Metrology (Packaged Commodities) Rules, 2011, that will come into effect from January 1, 2018. Under the new amended rules products on e-Commerce platforms have to display declarations required under the amended rules. Use of proper, accurate and standard weights and measures are very important for effective functioning of any economy, as it plays an indispensable role in consumer protection as protection from malpractices of under-weight or under-measurement, is an important function of the Government. The Legal Metrology (packaged Commodities) Rules, 2011 are framed to regulate the pre-packaged commodities. Under these rules, the pre-packaged commodities    have to comply with certain   mandatory lebelling requirements. Based on the experience of implementation   of the Rules and after a detailed stakeholder consultation, the Department has amended the rules, aimed at enhanced consumer protection, but at the same time balancing with the requirement of ease of doing business. Some of the salient features of the amendments are as below: Goods displayed by the seller on e-commerce platform shall contain declarations required under the Rules like name & Address of the manufacturer, packer and importer, name of the commodity, net content, retail sale price, consumer care complaint, dimention etc. Specific mention is made in the rules that no person shall declare different MRPs (dual MRP) on an identical pre-packaged commodity, unless allowed under any law. This will benefit consumers at large as they are having complaint regarding dual MRP for item depending upon different type of public places like Cinema Hall, Airport, Malls etc. Size of letters and numerals for making declaration is increased, so that consumer can easily read the same. The net quantity checking is made more scientific, with introduction of e-coding. Bar Code/QR Coding is allowed on voluntarily basis. Provisions regarding declarations on Food Products have been harmonized with labelling regulations under the Food Safety & Standards Act, 2006. Medical devices which are declared as drugs, Medical Devices such as stent, valve, orthopaedic implants, syringe, Tools for operations etc. Consumers at large were facing difficulty as prices of devices were sold according to the paying capacity of the consumer. Even after capping of MRP many companies were not displaying. Also there are important declarations other than MRP that need to be displayed, are brought into the purview of declarations to be made under the rules. The definition of Institutional Consumer has been changed to prevent any scope for commercial transactions/retail sale of commodities sourced by the institution for their own use. The rules shall come in to force with effect from 1st January, 2018. ]]> https://biospectrumindia.com/news/22/9175/isb-launches-startup-incubator-with-dst.html https://biospectrumindia.com/news/22/9175/isb-launches-startup-incubator-with-dst.html Fri, 30 Jun 2017 11:35:00 +0530 The Indian School of Business (ISB) has launched the facilities for its virtual startup incubation and acceleration arm DLabs. It plans to incubate approximately 50 companies during this year. The virtual incubation program which was launched in 2015 has mentored 32 startups so far. The incubator, which has been set up in collaboration with the Department of Science and Technology, Government of India, will be under the umbrella of ISB’s Centre for Innovation and Entrepreneurship (CIE). The business school also plans to add multiple incubators and accelerators in the coming months DLabs offers theme-based acceleration and incubation programs in sectors such as healthcare, financial technology, deep technology, social entrepreneurship, education technology, smart city, climate change, and nonprofit and civil society organizations. It will also connect startups with mentors and possible investors who can help the company scale-up. ISB is also going to launch an advanced management program for incubator managers. ]]> https://biospectrumindia.com/news/22/9170/mou-between-india-and-israel-on-national-campaign-for-water-conservation-in-india-.html https://biospectrumindia.com/news/22/9170/mou-between-india-and-israel-on-national-campaign-for-water-conservation-in-india-.html Thu, 29 Jun 2017 14:55:00 +0530 With an aim of conserving water for future generations, memorandum of understanding (MoU) between India and Israel on National campaign for Water Conservation in India has been approved by the union cabinet. The two countries shall work to enhance cooperation at the national, regional and international level to design, implement and monitor a professionally-designed National Water Conservation campaign in India. Putting water conservation on the national agenda in India, encouraging every citizen to save water in everyday life, generating awareness about water, promoting re-use, recharge and recycling of water and development of digital tools such as websites, mobile applications on the subject of water conservation are the main objectives which will be jointly worked upon by ministries of both countries. ]]> https://biospectrumindia.com/news/22/9165/malaria-dengue-chikungunya-cases-on-rise-in-delhi.html https://biospectrumindia.com/news/22/9165/malaria-dengue-chikungunya-cases-on-rise-in-delhi.html Wed, 28 Jun 2017 15:30:00 +0530 With monsoon approaching, Delhi has already witnessed 113 cases of Malaria, while dengue cases have inched close to 100. According to the data released by Muncipal Corporation on Tuesday, total number of chikungunya cases recorded stand at 149. 40 malaria cases have been recorded this month alone. Two new species of the carrier anopheles mosquito stephensi (urban vector) and culicifacies (rural vector) have been identified this year by National Institute of Malaria Research (NIMR). The Delhi government recently issued instructions to state-run and private hospitals along with nursing homes to increase their bed capacity by up to 20% for the next six months to deal with the possible outbreak of dengue and chikungunya. The government has also banned over-the-counter sale of non-steroidal anti-inflammatory drugs such as aspirin and brufen as their use may "pose a threat" to dengue patients. ]]> https://biospectrumindia.com/news/22/9164/veggie-alternative-for-gelatin-capsule-coating.html https://biospectrumindia.com/news/22/9164/veggie-alternative-for-gelatin-capsule-coating.html Wed, 28 Jun 2017 14:40:00 +0530 In order to give vegetarian alternative to people, government is now considering a proposal to replace animal based gelatin with plant cellulose for the coating of capsules. The proposal already has an approval from the country’s top drug regulator and it has now been forwarded by the union health minister to a scientific committee headed by professor C K Kokate. According to a statement given by senior official in the health ministry in one of the daily newspaper, "We want to be 100% sure about the safety and efficacy of plant cellulose because gelatin has been in use for ages. Therefore, we have forwarded all the scientific literature and data to the scientific panel. The committee's recommendations are likely to be final on this matter as it already has an approval from the Drugs Controller General of India (DCGI)” “The proposal forwarded to the scientific panel for evaluation includes all such suggestions along with data. While the proposal has the support of various quarters within the government, it has been so far opposed by the pharmaceutical industry as it is estimated to add to their manufacturing cost. The cost may not be significant with the technology available, and it would not be mandatory for companies. The idea is to provide consumers with a choice, especially when the technology is available. The over Rs 1 lakh crore Indian pharmaceutical industry extensively depends on gelatin”, he added ]]> https://biospectrumindia.com/news/22/9149/novel-scheme-vajra-launched-by-ministry-of-science-technology-.html https://biospectrumindia.com/news/22/9149/novel-scheme-vajra-launched-by-ministry-of-science-technology-.html Fri, 23 Jun 2017 13:30:00 +0530 The Union Ministry of Science & Technology has initiated a novel scheme VAJRA (Visiting Advanced Joint Research). It is a faculty scheme of Science & Engineering Research Board that allows foreign-based scientists to contribute to the Indian growth by working part-time in Indian laboratories and academic institutions. While launching the VAJRA portal, Dr Harsh Vardhan, Union Minister of Science & Technology said, “The portal VAJRA will not only help India to boost the global ranking of Indian institutions but also draw the best of research personnel to the country. India has a scientific collaboration with as many as 80 countries” “The foreign faculty members selected under the scheme would reside in India up to three months in a year and would be provided a lump sum amount of 15,000 dollars in the first month of residence and US 10,000 per month for the second and third month”, he added Under the scheme, the Ministry plans to invite top foreign scientists, including persons of Indian origin, to spend up to three months in Indian institutions. The area of research to be undertaken by visiting faculty members under the scheme would have to be at the cutting edge of science and technology and also be of relevance to India.     ]]> https://biospectrumindia.com/news/22/9148/mou-between-india-and-sri-lanka-for-cooperation-in-traditional-systems-of-medicine-and-homeopathy.html https://biospectrumindia.com/news/22/9148/mou-between-india-and-sri-lanka-for-cooperation-in-traditional-systems-of-medicine-and-homeopathy.html Fri, 23 Jun 2017 13:05:00 +0530 The Union Cabinet has given its approval for signing an Memorandum of Understanding (MoU) for cooperation in traditional systems of medicine and homoeopathy between Ministry of AYUSH and the Ministry of Health, Nutrition and Indigenous Medicine of the Government of Democratic Socialist Republic of Sri Lanka. The proposed MoU will enhance bilateral cooperation between the two countries in the areas of traditional medicine and homoeopathy. This will be of immense importance to both countries considering their shared cultural heritage. The financial resources necessary to conduct research, training courses, conferences / meetings will be met from the existing allocated budget and existing plan schemes of Ministry of AYUSH. The activities between the two sides will start immediately after the signing of the MoU by the two countries. The initiatives taken between the two countries will be as per the terms of reference of the MoU signed and will be a continuing process till the MoU remains in operation. ]]> https://biospectrumindia.com/news/22/9146/pilot-project-launched-by-icmr-to-track-hidden-dengue-cases.html https://biospectrumindia.com/news/22/9146/pilot-project-launched-by-icmr-to-track-hidden-dengue-cases.html Fri, 23 Jun 2017 12:05:00 +0530 The Indian Council of Medical Research (ICMR) has launched a pilot project in Pune to find hidden cases of dengue. According to ICMR officials, “The project involves developing a smart electronic surveillance system that might help predict a dengue outbreak” More than 1 lakh dengue cases were recorded in India last year. As per the statement given by Dr Soumya Swaminathan, director general, ICMR to one of the daily newspaper, “The reported cases are just the tip of the iceberg. To get a true picture of the dengue burden, a pilot project is being rolled out that aims at preparing a smart electronic surveillance system for dengue. Pune has seen large number of dengue cases in the past few years. The effort is to network with all healthcare providers to find hidden cases and identify hotspots in the city.” As part of the project, the team headed by Dr A C Mishra, former director of National Institute of Virology has collected more than 2,000 serum samples to detect antibodies against the dengue virus in the community and help prepare the electronic surveillance system for the city. ]]> https://biospectrumindia.com/news/22/9138/four-more-science-centres-opening-in-odisha.html https://biospectrumindia.com/news/22/9138/four-more-science-centres-opening-in-odisha.html Thu, 22 Jun 2017 11:25:00 +0530 Odisha Government has decided to set up four more science centres in different parts of the State to popularise science and technology among people. A resolution in this regard was passed at the first governing body meeting of the State Council of Science and Technology presided over by Chief Minister Naveen Patnaik recently. A science centre has already been set up at Tukurla in Bargarh district. The four new centres will be opened at Keonjhar, Jeypore, Gopalpur and Khandapara. The council decided to implement the new biotechnology policy-2016. Besides, a decision was also taken to initiate steps to open science laboratories in schools. A resolution was adopted to create five thematic divisions of the council. The first division will look after agriculture, water, energy and environment while the second one will be for research and development, start-ups, innovation and consultancy. Similarly, the third division will deal with science education and communication, intellectual property rights and patent while the fourth will look after rural technology, transfer of technology and social development. The fifth division of the council will deal with health services and bio-technology. The five divisions will have three resource persons each. ]]> https://biospectrumindia.com/news/22/9130/guidelines-on-yoga-asanas-to-be-issued-by-aiims.html https://biospectrumindia.com/news/22/9130/guidelines-on-yoga-asanas-to-be-issued-by-aiims.html Wed, 21 Jun 2017 11:00:00 +0530 AIIMS in collaboration with AYUSH ministry will soon come up with guidelines on yoga ‘asanas’ which are beneficial to combat certain ailments. This is in line with Prime Minister Narendra Modi’s appeal to focus on treatment of diseases through the ancient Indian spiritual discipline. Experts from Swami Vivekananda Yoga Anusandhana Samsthana S-VYASA in Bengaluru in partnership with the Centre for Integrative Medicines and Research at AIIMS are conducting evidence-based research to develop a set of protocols for various diseases.  AIIMS Director Dr Randeep Guleria emphasized that not all yoga exercises are effective and suitable for all conditions. Evidence-based research is being done to issue a detailed standard yoga protocol for prevention and treatment of different kinds of diseases. AIIMS has embarked on a randomised study to assess the efficacy of yoga to control migraine attacks which leads to severe headache. There have been previous studies according to which yoga increases the chemical serotonin, which eases the tightening of the brain’s blood vessels thus relieving migraines. Dr Guleria also mentioned that yoga was found to be as effective as standard pulmonary rehabilitation in improving dyspea, inflammatory markers and quality of life in patients suffering from Chronic Obstructive Pulmonary Disease. This is a good initiative towards a better healthcare management. ]]> https://biospectrumindia.com/news/22/9126/dcgi-approves-symbicort-320-marketing-for-astrazeneca.html https://biospectrumindia.com/news/22/9126/dcgi-approves-symbicort-320-marketing-for-astrazeneca.html Tue, 20 Jun 2017 16:35:00 +0530 AstraZeneca Pharma India Limited, a leading global biopharmaceutical company has received marketing authorisation from the Drug Controller General of India (DCGI) for Symbicort 320 mcg.  Symbicort 320 mcg is a fixed-dose combination drug comprising budesonide and formoterol fumarate dehydrate delivered through a special device. It is indicated for treatment of severe Asthma and for patients with moderate to severe COPD with frequent symptoms and a history of exacerbations. Symbicort is approved for use in 91 countries for the treatment of Asthma and COPD. Results from AstraZeneca’s two major clinical studies have shown that the addition of formoterol to budesonide improved asthma symptoms and lung function, and reduced exacerbation. Similarly, in two 12-month studies in patients with COPD, Symbicort was superior to placebo, formoterol and budesonide regarding lung function and showed a significant reduction in the exacerbation rate compared with placebo and formoterol. Dr. Anilda D’souza, Head, Medical Affairs & Regulatory, AstraZeneca India stated that asthma and COPD are common and major causes of chronic morbidity impacting millions of patients in India. It is often not well controlled by existing treatments. AstraZeneca India is pleased to bring Symbicort 320 mcg, which will offer physicians and patients another treatment option for severe asthma and for moderate to severe COPD, where high dosage is required. Asthma is a common and chronic condition that affects the lungs’ airways. Inflammation and narrowing of the airways may cause wheezing, breathlessness, chest tightness and coughing. Symbicort, which is in the form of an inhalation powder, consists of a steroid and a long-acting beta agonist. The steroid component reduces irritation and inflammation and the beta agonist relaxes smooth muscle in the lungs and makes the airways wider, thereby decreasing symptoms. ]]> https://biospectrumindia.com/news/22/9122/mobile-app-celebrating-yoga-launched-to-connect-people-through-yoga-for-scientific-healthy-living-.html https://biospectrumindia.com/news/22/9122/mobile-app-celebrating-yoga-launched-to-connect-people-through-yoga-for-scientific-healthy-living-.html Tue, 20 Jun 2017 14:40:00 +0530 In order to popularise Yoga and encourage people to participate in it for a scientifically healthy living, Dr Harshvardhan, Minister for Science & Technology recently launched a mobile app “Celebrating Yoga”. This aspect of quality of life is aligned with the National Mission “Swasth Bharat” of the Government of India. The Department of Science & Technology has launched a research programme “Science and Technology of Yoga and Meditation (SATYAM)” under its Cognitive Science Research Initiative (CSRI). As Yoga and Meditation are interdisciplinary endeavors that interface with Neuroscience, Medicine, Psychology, Engineering, Philosophy etc., YOGA can contribute in a holistic way to derive integrated benefits. The app provides a platform to share information and insights about peoples’ participation in Yoga activities on the occasion of the International Yoga Day 2017. It will enable in capturing both mass events being organized in public places, schools and office complexes across the country and individual enthusiasts who are performing yoga to promote the celebration of the day and yoga performances. The information gathered through this app will be shared subsequently with the  Ministry of AYUSH to complement their efforts.   ]]> https://biospectrumindia.com/news/22/9112/european-approval-for-novartiss-new-drug.html https://biospectrumindia.com/news/22/9112/european-approval-for-novartiss-new-drug.html Mon, 19 Jun 2017 16:05:00 +0530 Swiss drugmaker Novartis has won European approval for its biosimilar version of Roche's blockbuster Rituxan as the crosstown rivals go head-to-head on a drug to treat blood cancers and immunological diseases. Novartis's medicine Rixathon is made by the company's generics unit Sandoz and aims to lure business away from Roche's medicine, also known as MabThera, with a lower price. Roche's Rituxan amassed 7.3 billion Swiss francs ($7.50 billion) in global sales in 2016. Sandoz is committed to increasing patient access to biologic medicines, and Rixathon will be one of the five major launches the company is planning in the next four years. This is Novartis's fourth biosimilar version - a near copy of a biological medicine - of a name-brand drug to be approved in Europe. Rixathon is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy. The active substance of Rixathon is rituximab, a monoclonal antibody that binds specifically to the transmembrane protein CD20 found on both malignant and normal B cells ]]> https://biospectrumindia.com/news/22/9091/niti-aayog-shortlisted-states-for-transformative-change-in-health-education.html https://biospectrumindia.com/news/22/9091/niti-aayog-shortlisted-states-for-transformative-change-in-health-education.html Thu, 15 Jun 2017 15:30:00 +0530 In order to catalyse transformational change in key social sectors, NITI Aayog has initiated a unique and novel initiative SATH Under recently launched program SATH (Sustainable Action for Transforming Human Capital) by NITI Aayog and its knowledge partners which will provide strategic, technical and implementation support to three states for each sector, committee comprising of NITI members was created. They spent two days assessing and vetting presentations by 14 States for each of the two social sectors. The states showcased the initiatives undertaken by them thus far, their willingness to accelerate improvement and justified why they should be selected for the institutional support being offered by NITI Aayog under the program. After final selection of the states, a Program Management Unit to push for efficiency and efficacy in governance structures and service delivery will be available at the state level for a period of 30 months. It is expected that these 36 months of focussed attention and support from the premier think tank will lead to a marked transformation and will also provide a model for other States to replicate and adapt. In health sector, five States have been shortlisted as run up to the final selection of three. These are, Uttar Pradesh, Bihar, Assam, Karnataka and Gujarat. Similarly in Education, the shortlisted States are Madhya Pradesh, Odisha, Chhattisgarh, Jharkhand and Andhra Pradesh. In both sectors, the States have to commit to a time-bound focus, governance reforms and delivery of outcomes for final selection for the partnership. ]]> https://biospectrumindia.com/news/22/9087/health-ministry-launches-intensified-diarrhoea-control-fortnight-idcf-.html https://biospectrumindia.com/news/22/9087/health-ministry-launches-intensified-diarrhoea-control-fortnight-idcf-.html Wed, 14 Jun 2017 17:00:00 +0530 In order to intensify efforts to reduce child deaths due to diarrhoea, Ministry of health and family welfare has launched the Intensified Diarrhea Control Fortnight (IDFC) Through this initiative, the ministry will mobilize health personnel, state governments and other stakeholders to prioritize investment in control of diarrhea, one of the most common childhood illnesses. It aims to create mass awareness about the most effective and low-cost diarrhoea treatment which is a combination of Oral Rehydration Salt (ORS) solution and Zinc tablets.  During the fortnight, intensified community awareness campaigns on hygiene and promotion of ORS and Zinc therapy will be conducted at state, district and village levels. Nearly 12 crore under 5-children will be covered during the program across the country. Under this initiative, distribution of ORS packets will be the responsibility of ASHA worker. ORS-Zinc corners will be set-up at health care facilities and non-health facilities such as schools and Anganwadi centres. Frontline workers will hold demonstration of ORS preparation, along with counselling on feeding during diarrhea and hygiene and sanitation. The activities are also being supported by other ministries of the Government of India, especially the Education, Panchayati Raj Institutions, Women and Child Development, and Water and Sanitation.         ]]> https://biospectrumindia.com/news/22/9086/cabinet-approves-mou-between-india-and-palestine-on-agriculture-cooperation-.html https://biospectrumindia.com/news/22/9086/cabinet-approves-mou-between-india-and-palestine-on-agriculture-cooperation-.html Wed, 14 Jun 2017 16:35:00 +0530 The Union Cabinet has given its ex-post facto approval to the Memorandum of Understanding (MoU) between Ministry of Agriculture & Farmers’ Welfare and the Ministry of Agriculture in the State of Palestine on agriculture cooperation.  The MoU was signed in May 2017 during the visit of the Palestinian Minister of Foreign Affairs to India.  Under the MoU, cooperation will be given in the fields of agricultural research; veterinary field including capacity enhancement of Palestinian Veterinary services and Animal Health; irrigation and climate change along with areas such as plant and soil nutrition; exchange of experiences in the field of sanitary and phytosanitary legislation and plant protection Animal husbandry, modern irrigation technology including exchange of experiences, and training and capacity building, etc. In order to determine the programs and action plans to achieve the objectives provided in the MoU, an agriculture steering committee will be also be constituted. ]]> https://biospectrumindia.com/news/22/9084/government-gives-a-nod-to-microcephaly-zika-link-test.html https://biospectrumindia.com/news/22/9084/government-gives-a-nod-to-microcephaly-zika-link-test.html Wed, 14 Jun 2017 16:25:00 +0530 The Health Ministry started tracking cases of microcephaly in India in February 2016, after the World Health Organization (WHO) requested countries to track and report cases. There have been around 260 cases of Microcephaly in India since February 2016. The Health Ministry did not test the babies for the virus citing shortage of laboratory capacity while investigating to study the link between the condition and Zika virus. A three-month-old baby was detected with severe microcephaly tested negative for Zika. This was the first case since 2015-16 where the Ministry ran blood work for Zika to break global outbreak. Dr Ajay Khera, Deputy Commissioner for Child Health, Health Ministry, said, “We could not check any of the cases for link with Zika because the programme had not evolved to that point. We will start checking microcephaly cases for Zika links from now.” A baby can be affected by severe microcephaly if his brain has not been developed during pregnancy or because it was damaged during pregnancy. Dr. Soumya Swaminathan, Director General of Indian Council of Medical Research (ICMR), said, “Aetiology testing, investigation to establish the cause of the condition, of these babies was not done because laboratories were not available. We don’t have baseline data for microcephaly. The government has only recently started collecting data on congenital birth defects. When we found cases of microcephaly, we could not test them for causes as labs were not available.” Dr. P.Ravindran, Director, Emergency Medical Relief (EMR), Health Ministry, further said, “The Indian government set up 55 sentinel sites across India. Over the year, we found sporadic cases, but without clustering.”       ]]> https://biospectrumindia.com/news/22/9083/generic-drug-stores-at-railway-stations.html https://biospectrumindia.com/news/22/9083/generic-drug-stores-at-railway-stations.html Wed, 14 Jun 2017 16:05:00 +0530 To ensure easy accessibility of quality and affordable medicines to common man, Indian Railways will soon open generic medicine stores, or Janaushadhi Kendras, at stations and other Railways establishments. An “in-principle decision” in this regard was arrived at after a meeting beween Minister for Chemicals & Fertilisers and Parliamentary Affairs Ananthkumar and Railways Minister Suresh Prabhakar Prabhu recently. The decison is in line with Prime Minister Narendra Modi’s vision of making affordable and quality medicines accessible to all citizens of the country under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP). Currently more than 1,600 such stores are operating in over 450 districts across India. The modalities of the project will be worked out by senior officials of the Ministry for Chemicals and Fertilisers and Ministry of Railways. India is a global leader in generic medicines, which are equivalent to branded products in dosage, strength, quality and performance, and are available at affordable costs. As cost of medicine forms a considerable proportion of out-of-pocket healthcare expense of common man, the government had recently asked doctors to prescribe medicines by their generic names. ]]> https://biospectrumindia.com/news/22/9059/sath-programme-launched-by-niti-aayog-.html https://biospectrumindia.com/news/22/9059/sath-programme-launched-by-niti-aayog-.html Mon, 12 Jun 2017 12:15:00 +0530 With the vision of initiating the transformation in the education and health sectors, NITI Aayog has launched SATH programme providing ‘Sustainable Action for Transforming Human Capital’ with the state governments. This programme aims to identify and build three future ‘role model’ states for health systems. NITI Aayog will work in close collaboration with their state machinery to design a robust roadmap of intervention, develop a programme governance structure, set up monitoring and tracking mechanisms, hand-hold state institutions through the execution stage and provide support on a range of institutional measures to achieve the end objectives. The programme will be implemented by NITI along with McKinsey & Company and IPE Global consortium, who were selected through a competitive bidding process. To select the three model states, NITI defined a three-stage process – expression of interest, presentations by the states and assessment of commitment to health sector reforms. Andhra Pradesh, Assam, Bihar, Chandigarh, Goa, Gujarat, Haryana, Jharkhand, Karnataka, Madhya Pradesh, Odisha, Punjab, Telangana and Uttar Pradesh presented their project proposal to a committee headed by member of NITI Aayog,  Bibek Debroy and comprising of CEO, Amitabh Kant as well as a representative from the Ministry of Health and Family Welfare. The programme will be launched in the three selected states after the signing of MoUs.   ]]> https://biospectrumindia.com/news/22/9058/drug-controller-to-regulate-manufacturing-of-oxytocin.html https://biospectrumindia.com/news/22/9058/drug-controller-to-regulate-manufacturing-of-oxytocin.html Fri, 09 Jun 2017 17:20:00 +0530 Drug Controller is now planning to regulate manufacturing of hormone drug Oxytocin to Public sector undertakings (PSUs). Oxytocin is a hormone known to trigger a wide variety of physical and psychological effects and is commonly used to facilitate childbirth. The Government of India banned retail sale of the hormone in 2014 after it was found that indiscriminate use of Oxytocin in milch animals and by farmers was causing irreversible hormone damage. According to the statement given by G.N. Singh, Drug Controller General of India in one the daily newspaper, “We want to restrict the manufacturing of active pharmaceutical ingredient [API] to PSUs. The Health Ministry’s idea is to restrict everything is to public sector and as the drug regulator, we agree with the government’s thinking. This will be done at the earliest.” In March 2016, the Himachal Pradesh High Court directed the Central government to “consider the feasibility of restricting the manufacture of Oxytocin only in public sector companies and also restricting and limiting the manufacture by companies to whom licences have already been granted.” ]]> https://biospectrumindia.com/news/22/9046/who-adds-medicines-for-hepatitis-c-hiv-tuberculosis-and-cancer-to-essential-medicines-list.html https://biospectrumindia.com/news/22/9046/who-adds-medicines-for-hepatitis-c-hiv-tuberculosis-and-cancer-to-essential-medicines-list.html Thu, 08 Jun 2017 16:55:00 +0530 WHO experts have grouped antibiotics into three categories – ACCESS, WATCH and RESERVE. New advice on which antibiotics to use for common infections and which to preserve for the most serious circumstances is among the additions to the WHO Model list of essential medicines for 2017. Other additions include medicines for HIV, hepatitis C, tuberculosis and leukaemia. The updated list adds 30 medicines for adults and 25 for children, and specifies new uses for 9 already-listed products, bringing the total to 433 drugs deemed essential for addressing the most important public health needs. The WHO Essential Medicines List (EML) is used by many countries to increase access to medicines and guide decisions about which products they ensure are available for their populations. Dr Marie-Paule Kieny, WHO Assistant Director-General for Health Systems and Innovation said, "Safe and effective medicines are an essential part of any health system. Making sure all people can access the medicines they need, when and where they need them, is vital to countries’ progress towards universal health coverage." WHO recommends that antibiotics in the ACCESS group be available at all times as treatments for a wide range of common infections. For example, it includes amoxicillin, a widely-used antibiotic to treat infections such as pneumonia. The WATCH group includes antibiotics that are recommended as first- or second-choice treatments for a small number of infections. For example, the use of ciprofloxacin, used to treat cystitis (a type of urinary tract infection) and upper respiratory tract infections (such as bacterial sinusitis and bacterial bronchitis), should be dramatically reduced to avoid further development of resistance. The third group, RESERVE, includes antibiotics such as colistin and some cephalosporins that should be considered last-resort options, and used only in the most severe circumstances when all other alternatives have failed, such as for life-threatening infections due to multidrug-resistant bacteria.     ]]> https://biospectrumindia.com/news/22/9033/national-human-milk-bank-and-lactation-counselling-centre-inaugurated-by-health-secretary.html https://biospectrumindia.com/news/22/9033/national-human-milk-bank-and-lactation-counselling-centre-inaugurated-by-health-secretary.html Wed, 07 Jun 2017 16:05:00 +0530  ‘Vatsalya – Maatri Amrit Kosh’,  National human milk bank and Lactation counselling centre has been inaugurated by C K Mishra, Secretary (Health and Family Welfare) at the Lady Hardinge Medical College (LHMC) today. Speaking on the occasion, Mishra said, “This would be the largest human milk bank and lactation counselling centre available under the public sector in North India. It is envisaged that with this donor human milk bank, all newborns in and around Delhi will have access to life saving human milk regardless of the circumstances of their birth.” “When we know the potential of mother’s milk for a child, breastfeeding rates are low in India. He informed the participants that the early initiation of breastfeeding is only 40%, even when the institutional delivery has increased to 78.9%. In view of this, we launched Mothers Absolute Affection (MAA) programme to create awareness regarding breastfeeding as being the most cost-effective way of enhancing the child’s immunity,” he added Addressing the gathering, Nils Ragnar Kamsvag, Ambassador of Norway to India said, “Human milk increases survival rate for those neonates whose mother cannot produce enough milk. I am proud in being a partner with Lady Hardinge Medical College (LHMC) in this endeavour and I am confident that this will provide guidance, inspiration and guidelines for more such milk banks for helping sick newborn babies.” This national human milk bank and lactation counseling centre will collect pasteurize, test and safely store milk that has been donated by lactating mothers and make it available for infants in need. In addition, this facility will protect, promote and support breastfeeding of their own healthy mothers by providing lactation support to mothers through dedicated lactation counsellors. This initiative is established in collaboration with the Norwegian government, Oslo University and Norway India Partnership Initiative (NIPI).      ]]> https://biospectrumindia.com/news/22/9010/10th-common-review-mission-crm-report-of-nhm-released-by-j-p-nadda.html https://biospectrumindia.com/news/22/9010/10th-common-review-mission-crm-report-of-nhm-released-by-j-p-nadda.html Mon, 05 Jun 2017 16:25:00 +0530 Tenth Common Review Mission (CRM) report of the National Health Mission was recently released by J P Nadda, Union Health Minister. Speaking at the function Nadda Said, “Strong healthcare systems are required to be put in place and time-bound and structured disease elimination plans need to be developed. Ensuring quality of healthcare in public and private sector is our key priority. However, new challenges demand we make innovative strategies and encourage new ideas and innovations and take advantage of them so that nobody is left untouched of our services.” Healthcare service delivery has improved in terms of quality and content of care, as evidenced by increased footfalls, for not just institutional delivery but also for outpatients and inpatients. Several new initiatives have been launched in the last three years, targeted towards expanding access and reducing costs, as the Ministry moves along the path to universal health care.”, he added Assuring full support to the states, he also urged the states to come forward with their proposals for rolling out innovative programmes for delivery of services. The Health Minister informed that under the universal screening of common NCDs program, everyone above the age of 30 years will be screened in the 100 districts of the country in the first phase. Addressing the participants, Faggan Singh Kulatste, Minister of State (Health & Family Welfare) said “NHM has led to improved health outcomes and health indicators due to strengthened system of healthcare delivery. National Health Mission continues to play an important role in strengthening public health systems at state and sub district levels” Speaking at the function, Anupriya Patel, Minister of State (Health & Family Welfare), said, “CRM is an important mechanism for review of NHM as it helps in conducting intense interaction at the ground for review of processes and quality. She urged the states for developing innovative strategies for universal health coverage and highlighted the key findings of the CRM report.” C.K. Mishra, Secretary (Health & Family Welfare) stated, “The inputs of CRM are very important to make the analyses the driving force for improvement of NHM. CRM provides the platform for critical analyses which is very unique to NHM. It assesses the quality parameters of the programme and gives us details about the returns on the investment.” The 10th CRM team visited 16 States/UTs, including 9 High Focus States including 3 North-Eastern States, 5 Non- High Focus States and 2 UTs. ]]> https://biospectrumindia.com/news/22/9007/medical-technology-association-of-india-mtai-calls-for-more-clear-norms-for-the-development-of-medtech-sector-in-india.html https://biospectrumindia.com/news/22/9007/medical-technology-association-of-india-mtai-calls-for-more-clear-norms-for-the-development-of-medtech-sector-in-india.html Mon, 05 Jun 2017 15:30:00 +0530 MTaI in a press conference recently held in New Delhi addressed the need for creating an ecosystem that fully supports technology in MedTech, from the perspectives of engineering design, human application, clinical validation and delivering the product in the hospital setting. They also emphasised on wider adoption of the medical devices which are developed in India is a necessary prerequisite in order for us to leverage the ‘Make in India’ initiative. Pavan Choudary, Director General, MTaI said, “The Government needs to recognize that the MedTech sector is capital intensive with a long gestation period requiring continual infusion of technology and accordingly take a nuanced approach in its policy-making mechanisms. Given that the global medical device industry has the technology legacy, the spectrum of understanding, and strong manufacturing footprint in India, it should be included in the ‘Make in India’ policy-drawing-board.” Varun Khanna, Director, MTaI said, “Three issues need to be immediately addressed to generate interest and actions on ‘Make in India’. First, we need globally harmonized regulatory policies providing safe and effective products for patients in India and abroad. Beyond product regulatory policy, policies around investments, infrastructure, research and development add to the appeal of manufacturing in India. Secondly, companies need to gain financial viability for making in India through various tax waivers or incentives. And thirdly, we need more impetus on healthcare infrastructure.” Probir Das, Board Member, MTaI, said, “Often, we compare ourselves with China on a number of matters. India has around 70% of medical devices imported. Currently, China which is around 10-times bigger in the medical device market in comparison to India, also imports around 70% of its medical devices consumption. It is important to create enough infrastructure and skills as we take the worthy idea of ‘Make in India’ forward.”   ]]> https://biospectrumindia.com/news/22/8993/china-to-evaluate-u-s-agricultural-biotechnology-product.html https://biospectrumindia.com/news/22/8993/china-to-evaluate-u-s-agricultural-biotechnology-product.html Fri, 02 Jun 2017 15:50:00 +0530 China will evaluate eight pending U.S. agricultural biotechnology product applications, potentially opening the door for sales by Dow AgroSciences, DuPont Pioneer, Monsanto, and Syngenta. According to a news source, China agreed to conduct the evaluations as part of an agreement unveiled by the White House on May 12. The two countries reached the trade deal after a meeting in April between U.S. President Donald J. Trump and Chinese President Xi Jinping. U.S. officials have prodded China for years to speed up its lengthy process for deciding whether to approve the import of new genetically modified (GM) crops. It typically takes six years to win Chinese clearance of a GM variety, twice as long as other major nations take. Under the new deal, China’s National Biosafety Committee will meet to assess the safety of eight products made by four major U.S. agrochemical companies. Dow AgroSciences is seeking approval for its corn and soybean seeds, while Syngenta and DuPont Pioneer have each applied to sell a GM corn variety in China. Monsanto makes four of the products pending approval, including herbicide-tolerant corn, soybeans, and two alfalfa varieties that have been under review for nearly six years. The Biotechnology Innovation Organization (BIO), an industry trade group, wants to make sure China lives up to its commitment. “The ultimate test of success will be for China to follow its process and quickly approve the eight pending biotechnology applications and establish a synchronized, timely, and predictable process going forward,” says Joseph Damond, senior vice president for international affairs at BIO.   ]]> https://biospectrumindia.com/news/22/8975/run-dengue-chikungunya-campaign-like-swachh-bharat-high-court.html https://biospectrumindia.com/news/22/8975/run-dengue-chikungunya-campaign-like-swachh-bharat-high-court.html Wed, 31 May 2017 17:00:00 +0530 The Delhi High Court on recently said the Delhi government should run awareness programmes on dengue and chikungunya, similar to the pan-India campaign on Swachh Bharat Abhiyan . A bench of Acting Chief Justice Gita Mittal and Justice C Hari Shankar said as the Swachh Bharat had Abhiyan made a big impact across the nation, the Delhi government should do something similar.  "It is a very good attempt by the central government. It is everywhere, whether its TV, radio or newspapers. So something on that line should be done for dengue and chikungunya," the bench observed and told the Delhi government "you should do that". The bench also pulled up the Centre, the Delhi government and the civic bodies here over their failure to issue advertisements highlighting the preventive steps to check vector-borne diseases in the city. However, the counsel for all the authorities submitted that preventive steps have been taken and advertisements also issued. The counsel for the Centre said they had long-term plans to tackle vector-borne diseases, to which the court asked whether they had any short-term plans.   ]]> https://biospectrumindia.com/news/22/8969/indian-and-australian-experts-shift-their-radar-on-digital-health-and-its-future-.html https://biospectrumindia.com/news/22/8969/indian-and-australian-experts-shift-their-radar-on-digital-health-and-its-future-.html Wed, 31 May 2017 16:20:00 +0530 In a bid to take the digital health segment to a whole new level in India, the George Institute for Global Health Global Health, in partnership with the Australian High Commission, conducted a Digital Health and Technology roundtable in Delhi. Australian and Indian health experts, policymakers, and business and thought leaders came together to discuss the solutions required in health services delivery, advances in medical health and digital technologies, regulatory challenges and implementation experiences in both countries. The roundtable is one of the first activities to be held under the Health MoU exchanged between Prime Minister Turnbull and Prime Minister Modi in April this year. Dr. Vivekanand Jha, Executive Director of the George Institute for Global Health in India, said “India has recently launched the National Health Policy 2017 which articulates the need for increasing access, improving quality and lowering the cost of healthcare delivery. This roundtable was organised with a view to support this vision.” During discussions, Acting High Commissioner for Australia, Chris Elstoft, noted Australia’s leadership in delivering secure, quality, health services with the aid of digital technology, and the establishment of the Australian Digital Health Agency to support this. Jill Hennessy MP, Health Minister of the State of Victoria, Australia opined that the key investment in Victoria is the electronic referral (eReferral) program, which has enabled health professionals to share clinical information securely in the delivery of health services. ]]> https://biospectrumindia.com/news/22/8950/chemists-on-nationwide-strike-over-e-pharmacy-regulations.html https://biospectrumindia.com/news/22/8950/chemists-on-nationwide-strike-over-e-pharmacy-regulations.html Tue, 30 May 2017 13:25:00 +0530 Nearly 8.5 lakh private medicine shops across the country will remain closed on today as the All India Organisation of Chemists and Druggists (AIOCD) calls for a nationwide protest against the e-pharmacy regulations that the Central government is deliberating upon in support of online sale of drugs. Jagannath Shinde, AIOCD president said, “The association believes that the proposal of e-portal will lead to scarcity of medicines in the country.” Following a government public notice in April on e-portal , AIOCD proposed amendments to Drug and Cosmetic Act of 1940 and permission to online sell of medicines be put on hold till the Government draft is changed. It had submitted a memorandum to the Union Health Ministry in this regard. Prashant Tandon, president, Indian Internet Pharmacy Association (IIPA), an umbrella body for e-pharma portals said, “e-pharmacy will enable transparent drug dispensing mechanism and give high accountability as the entire procedure will be tracked.” ]]> https://biospectrumindia.com/news/22/8925/bp-medicine-by-glenmark-gets-usfda-nod.html https://biospectrumindia.com/news/22/8925/bp-medicine-by-glenmark-gets-usfda-nod.html Fri, 26 May 2017 15:10:00 +0530 Glenmark Pharmaceuticals received final approval from the US health regulator for its generic version Olmesartan Medoxomil Tablets, used in treatment of high blood pressure. The approval granted by the US Food and Drug Administration to Glenmark Pharmaceuticals Inc is for multiple strengths of 5 mg, 20 mg and 40 mg. These are the generic equivalent of Benicar Tablets of Daiichi Sankyo, Inc. Glenmark's Olmesartan Medoxomil tablets will be manufactured by the company's manufacturing facility located in Goa, India. Citing IMS Health sales data for the 12-month period ended March 2017, Benicar achieved annual sales of about $950 million. Glenmark's current portfolio consists of 115 products authorised for distribution in the US market and approximately 69 ANDA's (Abbreviated New Drug Application) pending approval with the USFDA. ]]> https://biospectrumindia.com/news/22/8919/germany-and-india-to-cooperate-in-alternative-medicine-.html https://biospectrumindia.com/news/22/8919/germany-and-india-to-cooperate-in-alternative-medicine-.html Thu, 25 May 2017 17:55:00 +0530 The Union Cabinet chaired by the Prime Minister Narendra Modi has approved the Joint Declaration of Intent (JDI) between Germany and India regarding cooperation in the sector of alternative medicine.  The signing of the JDl will enhance bilateral cooperation between the two countries in the areas of traditional/alternative medicine. Initiation of collaborative research, training and scientific capacity building in the field of alternative medicine under the JDI between the two countries would contribute to the enhanced employment opportunities in the AYUSH sector.  There are no additional financial implications involved. The financial resources necessary to conduct research, training courses, conferences / meetings will be met from the existing allocated budget and existing plan schemes of Ministry of AYUSH.  India is blessed with well-developed systems of traditional medicine which hold tremendous potential in the global health scenario. Germany has considerable interest in Traditional Systems of Medicine. The Ministry of AYUSH as a part of its mandate to propagate Indian systems of Medicine globally has taken effective steps by entering into MoU with China, Malaysia, Trinidad & Tobago Hungary, Bangladesh, Nepal, Mauritius, Mongolia and Myanmar.  The Ministry has taken many initiatives for promotion of Ayurveda in Germany with the recommendation and cooperation of the Indian Embassy in Berlin. One of the major initiatives is the collaborative research Project between the Central Council for Research in Ayurvedic Sciences (CCRAS) and Charite University, Berlin on Osteoarthritis of the knee. The results of the trial are encouraging and the clinical trial demonstrates significant improvement in patients. The study has been completed successfully and is under publication.  A delegation led by Shripad Yesso Naik, Minister of State, (Independent Charge), Ministry of AYUSH had visited Germany from 15-19 October 2016 to participate in the 2nd European World Ayurveda Congress (EWAC) and have interactions with the authorities in Germany. The Congress was supported by the Ministry of AYUSH. During the visit a bilateral meeting was held between MoS (IC), AYUSH with the Parliamentary State Secretary Ms. Ingrid Fischbach during which both sides had unanimously agreed to begin the process of drafting and negotiating a JDl in the field of AYUSH and Natural medicine. It is expected that the JDI would give a boost to India-Germany ties and enhance cooperation between the two countries.    ]]> https://biospectrumindia.com/news/22/8917/icmr-signs-agreement-with-emami-to-develop-herbal-drugs.html https://biospectrumindia.com/news/22/8917/icmr-signs-agreement-with-emami-to-develop-herbal-drugs.html Thu, 25 May 2017 16:55:00 +0530 Indian Council of Medical Research (ICMR) and Emami Healthcare have signed two memoranda of understanding (MoU), one for the development of standardized phytopharmaceutical formulation to prevent or delay the development of Type-2 Diabetes in people with pre-diabetes and another for the development of standardized herbal or ayurvedic formulation to treat sleep disorders. The MoUs were signed by Dr Soumya Swaminathan, Director General, ICMR, New Delhi and Dr C K Katiyar, CEO, Emami Healthcare, Kolkata.  ICMR will mainly support and manage the pre-clinical, toxicological and clinical development phase of the product development programmes, whereas the industry will look after and undertake the chemistry, manufacturing and control (CMC) part of the product development phase. Emami Healthcare is expected to manufacture the herbal drugs within a period of 18 months. The company will take care of all CMC (Chemistry, Manufacturing, and Control) including pre-clinical toxicology, and later on ICMR will sponsor the clinical trials at AIIMS to prove the safe parameters and effectiveness of the drugs. ]]> https://biospectrumindia.com/news/22/8915/india-to-implement-who-standards-on-reporting-clinical-trial-results.html https://biospectrumindia.com/news/22/8915/india-to-implement-who-standards-on-reporting-clinical-trial-results.html Thu, 25 May 2017 15:30:00 +0530 The Indian Council of Medical Research (ICMR) has joined hands with other global agencies to implement World Health Organization (WHO) standards on reporting clinical trial results.  In a joint statement, issued recently the ICMR along with the Norwegian Research Council, the UK Medical Research Council, Médecins Sans Frontières and Epicentre (its research arm), PATH, the Coalition for Epidemic Preparedness Innovations (CEPI), Institut Pasteur, the Bill & Melinda Gates Foundation, and the Wellcome Trust agreed to develop and implement policies within the next 12 months that require all trials they fund, co-fund, sponsor or support to be registered in a publicly-available registry. They also agreed that all results would be disclosed within specified timeframes on the registry and/or by publication in a scientific journal. Some of the world’s largest funders of medical research and international non-governmental organizations met at Geneva on May 18 and agreed on new standards that will require all clinical trials they fund or support to be registered and the results disclosed publicly.  In a statement welcoming the agreement of international standards for reporting timeframes that everyone can work towards, Dr Soumya Swaminathan, Director-General of the Indian Council of Medical Research said, “We need timely clinical trial results to inform clinical care practices as well as make decisions about allocation of resources for future research.”  Today, about 50% of clinical trials go unreported, according to several studies, often because the results are negative. These unreported trial results leave an incomplete and potentially misleading picture of the risks and benefits of vaccines, drugs and medical devices, and can lead to use of suboptimal or even harmful products.  "Research funders are making a strong statement that there will be no more excuses on why some clinical trials remain unreported long after they have completed," said Dr Marie-Paule Kieny, Assistant Director-General for Health Systems and Innovation at WHO.  The signatories to the statement also agreed to monitor compliance with registration requirements and to endorse the development of systems to monitor results reporting.  In 2015 WHO published its position on public disclosure of results from clinical trials, which defines timeframes within which results should be reported, and calls for older unpublished trials to be reported. That position builds on the World Medical Association’s Declaration of Helsinki in 2013. Today’s agreement by some of the world’s major research funders and international NGOs will mean the ethical principles described in both statements will now be enforced in thousands of trials every year.  "Requiring summary results of clinical trials to be made freely available through open access registries within 12 months of study completion is good for both science and society," said Dr Jeremy Farrar, Director of the Wellcome Trust. "Not only will this help ensure that these research findings are more discoverable, but it will also reduce reporting biases, which currently favour publication of trials which have a positive outcome. Today’s statement is in line with Wellcome’s broader ambition to make all research outputs which arise from our funding more findable, accessible, and re-usable."  Most of these trials and their results will be accessible via WHO’s International Clinical Trials Registry Platform, a unique global database of clinical trials that compiles data from 17 registries around the world, including the United States of America’s clinicaltrials.gov, the European Union’s Clinical Trials Register, the Chinese and Indian Clinical Trial Registries and many others.  "We fully support this statement and look forward to working towards increasing the availability of results from clinical trials,” said Dr John-Arne Røttingen, Chief Executive of the Research Council of Norway. “The public disclosure of results from clinical trials will improve resource allocation to research in a broad sense, and is also in line with our policies on transparency, and on open access."  Commenting on agreement Dr Micaela Serafini, Medical Director, Médecins Sans Frontières said "Timely reporting of all clinical trial results is of upmost importance to MSF allowing fully informed decisions when it comes to health strategies, treatments and diagnostics. We fully support this move towards increased transparency and accountability in clinical research."  Dr Trevor Mundel, President, Global Health, Bill & Melinda Gates Foundation said "It's a 21st-century best practice – and an essential part of the social contract that underlies medical research – that clinical trial data should be made publicly available less than one year after a clinical trial's completion. We strongly support WHO's effort to establish a global standard for reporting data within this timeframe, which is a practice we require of our grantees as well."  Dr David C. Kaslow, Vice President of Essential Medicines at PATH said, "PATH remains deeply committed to the timely public disclosure of clinical trial results to accelerate development of new interventions and to ensure access to and transparency of safety and efficacy data, no matter if positive or negative. Full and consistent implementation of WHO standards on reporting clinical trial results is an important step towards better understanding the risks and benefits of vaccines, drugs, and medical devices, and the optimal use of new interventions." ]]> https://biospectrumindia.com/news/22/8907/icmr-to-implement-un-agencys-standards-on-clinical-trials.html https://biospectrumindia.com/news/22/8907/icmr-to-implement-un-agencys-standards-on-clinical-trials.html Thu, 25 May 2017 11:45:00 +0530 The Indian Council of Medical Research (ICMR), the Norwegian Research Council, the UK Medical Research Council, Medecins Sans Frontieres and Epicentre (its research arm), PATH, the Coalition for Epidemic Preparedness Innovations (CEPI), Institut Pasteur, the Bill & Melinda Gates Foundation and the Wellcome Trust agreed to develop and implement policies within the next 12 months that require all trials they fund, co-fund, sponsor or support to be registered in a publicly-available registry. These leading groups will adopt UN health agency's recommendations to register and publicly disclose results of all clinical trials they fund or support.  Dr Soumya Swaminathan, Director-General of the Indian Council of Medical Research said, "We need timely clinical trial results to inform clinical care practices as well as make decisions about allocation of resources for future research.” "We welcome the agreement of international standards for reporting timeframes that everyone can work towards," she added.  Dr Marie-Paule Kieny, Assistant Director-General for Health Systems and Innovation at World Health Organisation said, "Research funders are making a strong statement that there will be no more excuses on why some clinical trials remain unreported long after they have completed.” The signatories to the statement also agreed to monitor compliance with registration requirements and to endorse the development of systems to monitor results reporting.  Most of these trials and their results will be accessible via WHO's International Clinical Trials Registry Platform which is a unique global database of clinical trials that compiles data from 17 registries around the world. ]]> https://biospectrumindia.com/news/22/8901/cabinet-approves-mou-between-spain-and-india-on-cooperation-in-the-field-of-organ-transplant-services.html https://biospectrumindia.com/news/22/8901/cabinet-approves-mou-between-spain-and-india-on-cooperation-in-the-field-of-organ-transplant-services.html Thu, 25 May 2017 10:50:00 +0530 The Union Cabinet chaired by the Prime Minister Shri Narendra Modi has approved the signing of a Memorandum of Understanding (MoU) between the National Transplant Organization, Ministry of Health, Social Services and Equality, Spain and the Directorate General of Health Services, Ministry of Health and Family Welfare, India on cooperation in the field of Organ Transplant Services.  The MoU would facilitate bilateral cooperation in the field of organ and tissue procurement and transplantation and better understanding between the two countries. The knowledge gained will help in improving the services rendered to the patients suffering from end stage organ failure.  The Memorandum of Understanding is proposed to be signed during the forthcoming bilateral meeting with the Spanish side.    ]]> https://biospectrumindia.com/news/22/8902/foreign-scientists-to-work-in-indian-institutes.html https://biospectrumindia.com/news/22/8902/foreign-scientists-to-work-in-indian-institutes.html Thu, 25 May 2017 10:50:00 +0530 The Centre is all set to launch a first-of-its-kind program next month wherein foreign and NRI scientists can work in the country’s scientific institutions for a period of one to three months. The program titled ‘Visiting Advanced Joint Research’ (VAJRA) is aimed at encouraging top scientists to work in India and guide doctorate and post-doctorate students. The aim of the program is to expose the students to global research culture. The scientists selected under this program will be a cut above the rest in their respective fields. The faculty will be physically available for 1-3 months in the Indian institutions, but will maintain an adjunct faculty status round the year. The scientists under the VAJRA program would draw a salary of $15,000 in the first month and $10,000 each in the remaining months. The number of scientists under the program has been capped at 1,000. The government currently runs a program under ‘Ramanujan Fellowship’. However, it is aimed at attracting Indian students and doctors working abroad. The period of the fellowship is five years. ]]> https://biospectrumindia.com/news/22/8899/fda-nod-to-strides-shasun-for-dementia-drug.html https://biospectrumindia.com/news/22/8899/fda-nod-to-strides-shasun-for-dementia-drug.html Wed, 24 May 2017 16:15:00 +0530 Strides Shasun received approval from the US health regulator United States Food and Drug Administration (USFDA) for memantine hydrochloride tablets used in the treatment of dementia. The product will be manufactured at the company’s facility at Bengaluru and marketed by Strides Pharma Inc in the US market. The product will be launched immediately. The US market for memantine hydrochloride tablets USP, 5mg and 10 mg is approximately USD 60 million. Memantine hydrochloride belongs to a group of medicines called (NMDA)-receptor antagonists. It acts on these (NMDA)-receptors for improving the transmission of nerve signals and the memory. The Company has global manufacturing foot print with 8 manufacturing facilities spread across three continents including 6 US FDA approved facilities and 2 facilities for the emerging markets. ]]> https://biospectrumindia.com/news/22/8900/amrita-to-provide-medical-care-to-bangladesh-armed-forces.html https://biospectrumindia.com/news/22/8900/amrita-to-provide-medical-care-to-bangladesh-armed-forces.html Wed, 24 May 2017 16:15:00 +0530 The Amrita Institute of Medical Sciences (Amrita Hospital) is going to provide state-of-the-art specialty medical care to members of Bangladesh Armed Forces (BAF), including retired personnel, and their family members. A wide-ranging agreement for collaboration in patient care, medical education, research and training, and exchange of healthcare professionals was signed by Major General SM Motahar Hossain, Director General of Medical Services (DGMS), Bangladesh Armed Forces, and Dr. Prem Nair, Medical Director, Amrita Institute of Medical Sciences, Kochi. This collaboration will bring the two nations closer, even as members of Bangladesh Armed Forces benefit from the state-of-the-art medical expertise and infrastructure available at Amrita Hospital. Amrita hospital is going to set up telemedicine and tele-radiology facilities at the Combined Military Hospital in Dhaka which will connect doctors at Amrita Hospital to patients in Bangladesh for consultation. This collaboration will help save many lives as patients will be referred for complex surgeries and medical procedures. The agreement was signed in the presence of Dr. Prem Nair of Amrita Hospital and Brig. Gen. Abdul Hamid, Defence Adviser with Bangladesh High Commission. ]]> https://biospectrumindia.com/news/22/8889/special-fda-approval-for-cancer-treatment.html https://biospectrumindia.com/news/22/8889/special-fda-approval-for-cancer-treatment.html Wed, 24 May 2017 11:25:00 +0530 The U.S. Food and Drug Administration granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Keytruda (pembrolizumab) is indicated for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs. MSI-H and dMMR tumors contain abnormalities that affect the proper repair of DNA inside the cell. Tumors with these biomarkers are most commonly found in colorectal, endometrial and gastrointestinal cancers, but also less commonly appear in cancers arising in the breast, prostate, bladder, thyroid gland and other places. Approximately 5 percent of patients with metastatic colorectal cancer have MSI-H or dMMR tumors. ]]> https://biospectrumindia.com/news/22/8887/zydus-gets-approval-for-antihistamine-drug-.html https://biospectrumindia.com/news/22/8887/zydus-gets-approval-for-antihistamine-drug-.html Tue, 23 May 2017 17:50:00 +0530 Drug firm Zydus Cadila has received approval from the US health regulator to market antihistamine Cyproheptadine Hydrochloride tablets in the US market. The company has received final approval from the United States Food and Drug Administration (USFDA) to market Cyproheptadine Hydrochloride tablets in the strength of 4 mg. The tablets are used to relieve allergy symptoms such as hives, watery eyes, sneezing and itching eyes or nose The drug will be produced at the group's formulation manufacturing facility at the pharma SEZ in Ahmedabad. The group now has around 115 approvals from USFDA and has so far filed 300 abbreviated new drug applications (ANDAs). ]]> https://biospectrumindia.com/news/22/8882/gst-to-be-biggest-achievement-of-modi-govt-assocham.html https://biospectrumindia.com/news/22/8882/gst-to-be-biggest-achievement-of-modi-govt-assocham.html Tue, 23 May 2017 16:30:00 +0530 As the Narendra Modi is about to complete three years in office, its biggest achievement on economic front would be the Goods and Services Tax which is near a roll-out, while financial inclusion, digitisation and public investment on infrastructure like railways and power distribution are perceived as other credible steps for structural changes in the economy, the ASSOCHAM has said.  Based on a perception among its members, the ASSOCHAM has noted that benign inflation both at the retail and wholesale levels is among the other positives for the government. Of course, the fall in inflation was supported by a sharp correction in international commodity prices and good monsoon in the last season.  As the price rise remained within the target of four per cent, set by the Reserve Bank of India, the central bank has also been able to keep the interest rates low, though the credit off-take in the private sector still remains a challenge.  Prices of pulses, onion and other essential commodities, which used to hit the headlines, have come down significantly in the last 12-18 months.   "The implementation of GST in the next few weeks would cap other major initiatives of the government. The focus on improving ease of doing business through measures like GST and other taxation reforms has also been noted as one of the major achievements of the NDA Government," said the chamber President Mr Sandeep Jajodia.  Clean-up of the subsidy disbursal which had reached the proportion of bottomless pit, is yet another big plus of the government which is pursuing linkages of Aadhar ID with every bank account holder. Helped by favourable crash in the crude oil prices, elimination of subsidy on petrol and diesel and significant reduction in other fuels ,including cooking gas, have brought a great improvement in the balance sheets of the oil marketing companies.  Taking a look at other macros, it goes to the credit of the government that India's foreign exchange reserves have touched an impressive high of USD 372 billion, giving a muscle to rupee. While exporters have shown some concern, strong rupee is helping tame inflation further.   Thanks to  several measures to open up the Foreign Direct Investment (FDI) regime in key areas like defence, insurance, infrastructure, the country has received record net FDI of USD 100 billion in the last three years, while foreign funds are pumping in huge liquidity in the stock market.  Riding on ample liquidity and confidence of the global fund managers, India's market capitalisation has crossed a massive USD two trillion, so much so that some kind of caution is needed to handle such inflows.      "While, a high level of non-performing remains an area of concern, the government has taken some decisive measures like empowering RBI to set up Oversight Committees and refer the toxic assets for insolvency and all these should help resolution of the nagging problem." Other priority areas , going forward, should be focus on some of the stressed sectors like metals, construction and real estate, telecom and power generation while allocations for health and education needs to be lifted. Also, increased focus on agriculture must continue with enough allocations for rural and agri infrastructure like irrigation. However, a lot of work of work has been done in revival of the domestic fertiliser units.  ]]> https://biospectrumindia.com/news/22/8881/cabinet-approves-iacm-for-accelerating-discovery-research.html https://biospectrumindia.com/news/22/8881/cabinet-approves-iacm-for-accelerating-discovery-research.html Tue, 23 May 2017 14:35:00 +0530 The Cabinet Committee on Economic Affairs chaired by the Prime Minister Narendra Modi has given its approval for Industry-Academia Collaborative Mission (IACM) for accelerating discovery research to early development for biopharmaceuticals – “Innovate in India empowering biotech entrepreneurs & accelerating inclusive innovation” to be funded by the Government of India. The Mission will be implemented by Biotechnology Industry Research Assistance Council (BIRAC) a Public Sector Undertaking of Department of Biotechnology (DBT). The Mission Program would be a Pan-India program. The key focus areas of the program would aid in preparing India’s technological and product development capabilities in the biopharmaceutical sector to a level that it is globally competitive over the next 10-15 years and will transform the health standards of India’s population through affordable product development. For the implementation, a Programme Management Unit will be set up at BIRAC, which will work as an operational and functional arm for oversees and monitors program implementation and progress. The Mission will focus on development of specific products vaccines, biotherapeutics, medical devices and diagnostics; establishment of shared infrastructure and facilities; building and strengthening domain specific knowledge and management skills; creating and enhancing technology transfer capabilities in public and private sector. The Mission will provide a holistic and integrated approach to strengthen and support the entire product development value chain for accelerating the research leads to product development. This will help not only in immediate product development addressing public health needs, but also will help to create an ecosystem, which will facilitate development of a continuous pipeline of products. For implementation a Programme Management Unit will be set up at BIRAC, which will work as an operational and functional arm that oversees and monitors program implementation and progress.Key deliverables: The Mission will focus on Development of specific products Vaccines, biotherapeutics, medical devices and diagnostics; Establishment of Shared Infrastructure and facilities; Building and strengthening domain specific knowledge and management skills; Creating and enhancing technology transfer capabilities in public and private sector. The Mission will provide a holistic and integrated approach to strengthen and support the entire product development value chain for accelerating the research leads to product development. This will help not only in immediate product development addressing public health needs, but will also help to create an ecosystem which will facilitate development of a continuous pipeline of products. Total project cost to be funded by Government of India is Rs. 1500 crore for five years. Fifty percent costs for the Mission Programme will be arranged through the World Bank loan. Highlight of the mission ·  Pan India mission to be implemented by BIRAC ·   A US$250 M Mission with US$125 M coming as World Bank funding ·   Will create an ecosystem for innovative indigenous product development by researchers, start ups and SMEs and make Indian Biotech Industry Globally competitive ·  India which today occupies only 3% of the Biopharmaticals Global Market aims to reach 5% by 2022 ·  It will make the sector globally competitive over the next 10-15 years ·  It will transform the health standards of India’s population through affordable product development. ]]> https://biospectrumindia.com/news/22/8857/government-is-to-take-janaushadhi-scheme-to-every-block-ananthkumar-.html https://biospectrumindia.com/news/22/8857/government-is-to-take-janaushadhi-scheme-to-every-block-ananthkumar-.html Fri, 19 May 2017 12:10:00 +0530 Addressing the media on the achievements under The Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) New Delhi recently the Minister said that following the Prime Minister of India, Narendra Modi’s vision of making providing Affordable, Quality Medicines for All, the Government has made Health Security for all citizens its priority and this aim can only be achieved through the Janaushadhi pariyojana. Through this scheme, the Government is planning to take affordable medicines to each block of the country in near future. Union Minister for Chemicals & Fertilizers and Parliamentary Affairs, Ananthkumar said, "Today India is the World’s Pharmacy and our Pharma sector is growing at a pace of 20-21%. India is exporting quality generic medicines to 215 countries. PMBJP scheme is creating a silent revolution in achieving health security by providing affordable, quality medicines for all." Kumar informed that as on date, 1320 PMBJP Kendras (PMBJKs) are functioning in the country in the 30 States/UTs, covering 426 districts, as compared to only 80 opened between 2008 and 2014. The turnover in the beginning of the scheme was around Rs. 3 cror, which would increase to around Rs. 60 crore by end of this year, he informed. Further, the Minister said that MoUs for opening PMBJKs have been signed by Union Government with 19 State Governments and other Organisations/NGOs. A total of 32,225 applications have been received out of which in-principle approval has been given to 30,300 applications, which is a proof of the huge opportunity that this scheme provides for unemployed youth to get self-employed,  Kumar added.  Talking about the actual reduction in medicine prices, Kumar said that in these PMBJKs, the Government procured generic medicines are sold which are 50 - 90% less as compared to the branded medicines in open market, for e.g. the price of Amlodipine 5 mg 10 Tablets is Rs. 3.25 as compared to market average price of Rs. 20.00 for branded version. Further, the product basket of PMBJP contains more than 600 medicines and 154 surgicals and consumables in all therapeutic categories viz. Anti-infectives, Anti-diabetics, Cardiovasculars, Anti-cancers, Gastro-intestinal medicines, etc.  Most importantly, allaying the concerns about quality, the Minister said that each batch of drug supplied to PMBJKs is tested for impeccable quality assurance at NABL (National Accreditation Board Laboratories) accredited laboratories and is compliant with WHO GMP (Good Manufacturing Practices) benchmarks. Out of total 10,000 pharmaceuticals companies in India, 1400 are WHO GMP compliant and drugs under the PMBJP are procured only from these 1400 companies, Kumar said. Answering to a question on prescription of generic medicines by doctors, the Minister informed that due to sustained efforts of the Ministry, the Medical Council of India (MCI) has recently issued a directive to all medical colleges, hospitals, doctors across the country and made it mandatory to prominently mention Generic Names of drugs along with Brand Names in their prescriptions, in pursuance of which strict disciplinary action may be taken against the violators. All medical practitioners have been directed by the Government to strictly comply with its directions. Further, the Ministry of Health & Family Welfare has also issued advisory to all State Drug Controllers that all branded drugs, imported or domestically manufactured, should mandatorily contain generic names mentioned in bold letters while packaging,  Kumar added. It was also informed that in order to encourage doctors to prescribe generic medicines, the MCI had amended the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 on 08th October 2016 advising the use of generic name of drugs in doctor’s prescription. Informing about the Government’s efforts towards future expansion of PMBJKs in the country, Kumar said that the Ministry of Railways has come on board to open Janaushadhi kendras in over 1000 railway stations across the country in collaboration with Ministry of Chemicals & Fertilizers.  ]]> https://biospectrumindia.com/news/22/8852/cabinet-committee-on-economic-affairs-approves-industry-academia-collaborative-mission-for-accelerating-discovery-research-.html https://biospectrumindia.com/news/22/8852/cabinet-committee-on-economic-affairs-approves-industry-academia-collaborative-mission-for-accelerating-discovery-research-.html Thu, 18 May 2017 11:40:00 +0530 The Cabinet Committee on Economic Affairs chaired by the Prime Minister Narendra Modi has given its approval for Industry-Academia Collaborative Mission for accelerating discovery research to early development for biopharmaceuticals - "Innovate in India (13) empowering biotech entrepreneurs & accelerating inclusive innovation" to be funded by the Government of India. The Mission will be implemented by Biotechnology Industry Research Assistance Council (BIRAC) - a Public Sector Undertaking of Department of Biotechnology (DBT). The key focus areas of the program would aid in preparing India's technological and product development capabilities in the biopharmaceutical sector to a level that it is globally competitive over the next 10-15 years and will transform the health standards of India's population through affordable product development.  Total project cost to be funded by Government of India is Rs. 1500 crore for five years. 50% cost for the Mission Programme will be arranged through the World Bank loan. For the implementation, a Programme Management Unit will be set up at BIRAC which will work as an operational and functional arm that oversees and monitors program implementation and progress. The Mission will focus on Development of specific products - vaccines, biotherapeutics, medical devices and diagnostics; establishment of shared infrastructure and facilities; building and strengthening domain specific knowledge and management skills; creating and enhancing technology transfer capabilities in public and private sector. This will help not only in immediate product development addressing public health needs, but will also help to create an ecosystem which will facilitate development of a continuous pipeline of products. ]]> https://biospectrumindia.com/news/22/8837/dbt-holds-strategy-meet-to-build-100-billion-indian-biotech-by-2025.html https://biospectrumindia.com/news/22/8837/dbt-holds-strategy-meet-to-build-100-billion-indian-biotech-by-2025.html Mon, 15 May 2017 11:15:00 +0530 To mark the 75th anniversary of India’s independence and a $100 billion Indian biotechnology sector by 2025 the Department of Biotechnology (DBT) held a strategy meet on May 1 in New Delhi.  The strategy meet emphasized on a mechanism of rewarding promising projects of societal importance, taking them to translational stage & communicating them and also on skill development specially in the area of management of genetic disorders and genetic counseling. Research and Development for Cutting Edge Technologies like Genomics and Big Data Analysis, Stem Cell & Regenerative Medicine and Emerging trends in Structural Biology and their National Reach and Progress were highlighted. Several other areas of focus like health, with special focus on Maternal and Child Health as important measurements of social development, Drug Development, Human Development & Disease Biology, Vaccine Technology, Agriculture and Allied Areas and Energy and Environment for the country’s sustainable future were also discussed. Around 75 experts, directors and scientists from each of the DBT autonomous and associated institutions, DBT officials and other experts discussed the current status of Research & Development, Mission Programs, HRD, Entrepreneurship Development and International Cooperation Programs of the Department and ways to accelerate scientific development and reach its benefits to the people. Human Resource Development initiatives which are the anchors for future training, efforts to attract future talents as well as Programmes in the North Eastern Regions were discussed. Efforts on Entrepreneurship Development highlighted achievements in Nurturing and Fostering like numerous IPs, start-ups and entrepreneurs while DBT’s initiatives in Forging and Leveraging International Cooperation for making India Globally Competitive were also deliberated upon. While inaugurating the two day meet Minister for Science and Technology Dr Harsh Vardhan appreciated the efforts of the department and its associated institutes and pointed out that some achievements of each institute which are of social relevance should be selected and highlighted as National achievements. Secretary DBT, Professor VijayRaghavan highlighted the significance of the two day strategy meet and gave an overview of the deliberations. Senior Advisor DBT, Dr Renu Swarup gave a background of DBT’s National Biotechnology Development Strategy and of the steps taken as a follow up of the discussions held at the strategy meet 31st August, 2015, the major programmes & initiatives launched to address the identified priority areas. ]]> https://biospectrumindia.com/news/22/8833/mustard-set-to-be-indias-first-gm-food-gets-regulator-nod.html https://biospectrumindia.com/news/22/8833/mustard-set-to-be-indias-first-gm-food-gets-regulator-nod.html Fri, 12 May 2017 16:10:00 +0530 India's central biotech regulator, Genetic Engineering Appraisal Committee (GEAC) recently cleared the genetically modified (GM) Mustard for commercial cultivation and recommended its approval to the environment ministry. The GM mustard, developed by a Delhi University institution, is only the second food crop which got its clearance from the central regulator. The GEAC had earlier in 2010 cleared the Bt Brinjal but the decision was not accepted by then environment minister Jairam Ramesh. Currently, only Bt Cotton - a non-food GM crop - is commercially cultivated in the country. Amita Prasad, chairperson of the GEAC said, "The application on GM Mustard presented by Deepak Pental of South Campus (Delhi University) was appraised at the GEAC meeting held on Thursday. The GEAC has recommended the approval of GM Mustard to the environment ministry. Earlier, a sub-committee had appraised the safety document for GM Mustard", Pental, ex-vice chancellor of the Delhi University and a well-known genetics scientist, had filed the application for commercial release of the GM Mustard in December 2015. The GEAC had subsequently set up a sub-committee to examine the safety aspect of the use of transgenic variety of the mustard. The sub-committee had last year given its safety clearance while noting that the GM Mustard is safe for human consumption and environment. The 'Sarson Satyagraha', a broad platform of hundreds of NGOs representing farmers, consumers, scientists and others that has been at the forefront of resisting the approval of GM mustard in India' too condemned the green signal to the herbicide tolerant GM Mustard. Kavitha Kuruganti of the Alliance for Sustainable & Holistic Agriculture (ASHA) said, "The GEAC has proven yet again that it is unscientific and uncaring with regard to citizens' health and environment. They have failed in their very mandate and purpose for which they have been created, to protect citizens from risks of GMOs. Earlier in the case of Bt brinjal too, they behaved irresponsibly and shamelessly unscientifically. In this case, it is a hazardous herbicide tolerant food crop at that, which has direct implications for a large number of Indian farmers, agricultural workers and consumers" She, on behalf of the Sarson Satyagrah, said, "We have shown over the past several months, through rigorous analysis of available material, how this GM mustard dossier was rigged for favourable results, how it is an unneeded GMO, how it will increase chemicals in our food and farms (because it is a herbicide tolerant GMO) and how regulators should have never allowed it to proceed this far. They had ignored many valid questions raised by scientists and others and chose to function behind a shroud of secrecy". ]]> https://biospectrumindia.com/news/22/8828/shares-of-biocon-continue-to-fall-on-us-fda-observations.html https://biospectrumindia.com/news/22/8828/shares-of-biocon-continue-to-fall-on-us-fda-observations.html Fri, 12 May 2017 13:25:00 +0530 Shares of Biocon, India's largest and fully-integrated, innovation-led biopharmaceutical company, continue to fall for the third day today from May 10 after it received observations from US FDA in Form-483, leading to worries over further delay in approvals. The pharmaceutical watchdog from the US had inspected the company’s Bengaluru plant, before issuing a Form-483 listing out the 8 observations. Reacting to the development, company in a statement to BSE noted “form 483 is a standard outcome of any audit. Biocon has already responded to US FDA on all observations of the recent audit within stipulated timelines.’ The spokesperson of the company in press statement said “As a policy we do not comment on any schedule or outcomes of regulatory inspections, unless we believe that there is a material impact. Biocon has a good track record of inspections by the US FDA, European regulators and other regulators from developed and emerging markets.” A Form- 483 is issued when the US FDA finds possible violations of the US Food Drug and Cosmetic Act after an investigation. Biocon’s share prices at BSE opened on May 12 at Rs 999 while it closed at Rs 1008 on May 10. The company's share prices touched a 52 week high of Rs 1188 and low of Rs 615.80.  ]]> https://biospectrumindia.com/news/22/8817/intel-to-provide-health-care-support-to-parents-of-its-employees-in-india.html https://biospectrumindia.com/news/22/8817/intel-to-provide-health-care-support-to-parents-of-its-employees-in-india.html Thu, 11 May 2017 12:35:00 +0530 Intel has introduced Elder Care Program in India under which healthcare support will be given to its employees’ parents.Through the Elder Care Program, the US-based hardware and semiconductor major aims to offer better work environment to employees and help them care for their elderly parents and relatives at home. The programme will provide employees access to a range of essential health and wellness services for their parents and parents-in-law including home health aide, transport and escorting to and from medical appointments, home nurse visits, general physician and physiotherapy visits, sample collection and report delivery for medical tests and a dedicated helpline number for free medical and counselling. Preethi Madappa, director, human resource, Intel South Asia said, “We found in our own assessment there seems to be an increasing vulnerability that elderly seems to experience and this was coming to us from the data of medical claims of employees, percentage of claims and from which segment. We found that a large portion of that was coming in from the parents or the parent-in-laws” Intel has tied up with a third party vendor for Elder Care Program that manages the services across the country including specific tier-II cities.   “Life expectancy in India has increased in the past few years and multiple studies suggest it will go up further. This certainly prompted Intel to design a programme for the elderly family members of our employees and especially for those who stays away from family”, added Madappa. “We realised that employees feel that they are able to bring the best selves to work when they believe their entire well-being including family is taken care of. As a technology company we have best and the brightest young minds coming in but that also means their families and parents’ support is another aspect to be considered,” she added         ]]> https://biospectrumindia.com/news/22/8814/fda-studies-for-oncalert-cancer-test-commences.html https://biospectrumindia.com/news/22/8814/fda-studies-for-oncalert-cancer-test-commences.html Wed, 10 May 2017 18:00:00 +0530 Vigilant Biosciences, Inc., a leading innovator and developer of solutions that aid in the early detection and intervention of oral/oropharyngeal cancer, announced the launch and first patient enrollment for clinical studies of its OncAlert® point-of-care qualitative assay in support of its registration submission to the Food and Drug Administration (FDA).  Vigilant Biosciences' initial FDA clinical study is designed to validate performance and evaluate implementation of the OncAlert RAPID point-of-care qualitative assay into the standard of care paradigm for patients presenting with increased clinical risk for oral/oropharyngeal cancer. The study will enroll up to 1,000 patients with sites located in the United States as well as internationally. Part of the funding support Vigilant Biosciences will receive for the study will come from Renaissance Health Service Corporation, the parent organization for an extensive family of affiliated companies specializing in dental insurance and administration, technology, claims clearinghouse, and dental practice management services. The OncAlert Oral Cancer product line, includes the OncAlert Oral Cancer RAPID Test and the OncAlert Oral Cancer LAB Test, both CE Marked and available in select markets outside the United States. ]]> https://biospectrumindia.com/news/22/8801/kspcb-issues-notices-to-achira-semler-and-norwich-for-closure.html https://biospectrumindia.com/news/22/8801/kspcb-issues-notices-to-achira-semler-and-norwich-for-closure.html Tue, 09 May 2017 15:40:00 +0530 Karnataka State Pollution Control Board (KSPCB) has issued notices to 46 companies to close down under red categories for polluting Bellandur lake, the largest lake in the city. The KSPCB noted that of these 46 companies 16 are large scale, 2 medium and 28 are small scale companies.   One of the small scale companies which was issued notice include Achira Labs, a start-up in the area of medical diagnostics. Founded in 2009, the company is into developing proprietary lab-on-chip platforms to deliver medical affordable testing closer to the patient.   Founded by Dr Dhananjaya Dendukuri Achira Labs received grants and financial support from funding agencies in India and abroad. Funding agencies that supported Achira include Grand Challenges Canada, Biotechnology Industry Research Assistance Council and Indian Council of Medical Research along with funding partners C-CAMP.   The company has developed product panels in the clinical areas of thyroid disorders, fertility, diabetes and infectious disease. The product panels include β-hCG (human chorionic gonadotropin): A quantitative, confirmatory test for the pregancy hormone; FSH, LH, PL (Follicular stimulating hormone, Lutenizing hormone and Prolactin): A panel to assess female fertility and TSH, T4, T3 (Thyroid stimulating hormone, Thyroxine, Triiodothyronine): A quantitative test for Thyroid disorders.   As per KSPCB notification, for red category organisations, consents are granted valid for 5 years with effect from June 1, 2016.   KSPCB noted that Achira Labs has been using common effluent treatment plant (CETP) for wastewater and connected it toBengaluru Water Supply and Sewerage Board (BWSSB) underground drainage (UGD). Achira had taken the consent validity of KSPCB till June 30, 2017.   A few days back, the KSPCB has decided to shut down all 488 industries around Bellandur lake, in Bengaluru as per the directions of the National Green Tribunal (NGT). The KSPCB official noted that issuing individual orders to all companies will take time, so it has decided to do so through a newspaper notification. The companies have to implement the order with immediate effect.   Besides Achira Labs, other companies that were listed for closure in red category include Semler Research Centre and Norwich Clinical Services which are into R&D activity and bio-equivalence research studies both clinical and bio analytical. ]]> https://biospectrumindia.com/news/22/8794/medrobotics-receives-fda-approval.html https://biospectrumindia.com/news/22/8794/medrobotics-receives-fda-approval.html Tue, 09 May 2017 12:00:00 +0530 Medrobotics has received FDA regulatory clearance to market the Flex® Robotic System for colorectal procedures in the United States. Medrobotics is the first and only company to offer minimally invasive, steerable and shapeable robotic products for colorectal procedures in the U.S. The Flex® Robotic System is the world’s first robotic surgical platform to offer Scarfree™ access to hard-to-reach anatomy in otolaryngology and colorectal procedures. This provides surgeons treatment options that may not be possible with straight, rigid instruments. The minimally invasive Flex® Robotic System offers surgeons the unique ability to navigate complex anatomy through a single, small entry point to operate in difficult-to-reach places. Medrobotics is developing new surgical applications for its core platform technology in the areas of general surgery, gynecology, and urology, among others. These new applications are not yet cleared for use in the U.S. The award-winning Flex® Robotic System has been widely recognized for advances in surgical robotic technology, including Best-in-Show at the 2016 Medical Design Excellence Awards (MDEA) and a Best New Product at the 2017 Edison Awards. ]]> https://biospectrumindia.com/news/22/8789/karnataka-state-pollution-control-board-directs-pall-to-close-down-its-centre-in-bengaluru.html https://biospectrumindia.com/news/22/8789/karnataka-state-pollution-control-board-directs-pall-to-close-down-its-centre-in-bengaluru.html Mon, 08 May 2017 14:15:00 +0530 Pall India Pvt. Ltd, a fully owned subsidiary of Pall Corporation, is one of the 16 companies (under red category) which was asked by the Karnataka State Pollution Control Board (KSPCB) to close down.  As per KSPCB notification, for red category organisations, consents are granted valid for 5 years with effect from June 1, 2016.  KSPCB noted that Pall has been using common effluent treatment plant (CETP) for wastewater and connected it to Bengaluru Water Supply and Sewerage Board (BWSSB) underground drainage (UGD).  A few days back, the KSPCB has decided to shut down all 488 industries around Bellandur lake, in Bengaluru as per the directions of the National Green Tribunal (NGT). The KSPCB official noted that issuing individual orders to all companies will take time, so it has decided to do so through a newspaper notification. The companies have to implement the order with immediate effect.  Pall India, that operates from its headquarters based in Mumbai and employs more than 200 people located in regional offices all over the country.  As part of its global initiative to align with customers worldwide, Pall Corporation had opened its Life Sciences Centre of Excellence in Bengaluru in May 2007.  The centre drives process optimization innovations for the global life sciences market to meet the evolving opportunities and challenges of this fast-growing industry throughout Asia.  The centre includes a state-of-the-art proteomics laboratory to help customers speed the drug discovery process. It also houses a validation laboratory and a training facility with specialty experts to support Indian and regional customers as they increasingly enter the stringently regulated drug export market.  It may be noted that Pall Corporation was acquired by Danaher Corporation for $127.20 per share in cash, or $13.8 billion including assumed debt and net of acquired cash and Danaher had completed the acquisition of Pall on August 31, 2015 and as a result, Pall has become an indirect wholly owned subsidiary of Danaher.    ]]> https://biospectrumindia.com/news/22/8781/eris-lifesciences-gets-sebi-nod-for-ipo.html https://biospectrumindia.com/news/22/8781/eris-lifesciences-gets-sebi-nod-for-ipo.html Mon, 08 May 2017 17:05:00 +0530 Private equity firm ChrysCapital-backed Eris Lifesciences Ltd has received the Securities and Exchange Board of India’s (SEBI) approval for an initial public offering. The capital markets regulator issued final observations on the IPO proposal of the Ahmedabad-based pharmaceutical company on 28 April. Eris became the 12th company to receive regulatory nod this calendar year. An IPO and subsequent listing on stock exchanges will help Eris join a clutch of pharmaceutical companies that have either gone public over the past couple of years or have been planning to do so. The IPO of the Ahmedabad-based branded formulations company comprises 28.87 million shares through an offer for sale by ChrysCapital and promoters. This represents 21% stake dilution on a post-offer basis. The issue size is estimated to be around Rs 2,000 crore. This will value Eris at Rs 9,500-10,000 crore. ]]> https://biospectrumindia.com/news/22/8773/india-and-japan-intensify-cooperation-in-medical-device-regulations.html https://biospectrumindia.com/news/22/8773/india-and-japan-intensify-cooperation-in-medical-device-regulations.html Fri, 05 May 2017 17:20:00 +0530 India and Japan will intensify their joint cooperation for the development of a world-class medical device regulatory ecosystem in India, which will facilitate and expedite building up of a world-class medical device industry in India. This was the broad outcome of the 2nd Japan-India Medical Products Regulation Symposium held at Nihonbashi Life Science Building, Tokyo, recently. Top government and industry representatives attending the symposium from both the counties deliberated on ways to enhance cooperation in medical device and pharma sector. The host of the daylong conference was Ministry of Health, Labour and Welfare, Government of Japan and Japanese Pharmaceutical and Medical Device Agency. It was supported by Japan Pharmaceutical Manufacturers Association, Japan Federation of Medical Devices Association, Federation of Pharmaceutical Manufacturers’ Associations of JAPAN and Osaka Pharmaceutical Manufacturers Association. The Indian side was represented by topmost officials from Ministry of Health, Family and Welfare, Central Drugs Standard Control Organisation, members from Ficci, Pharmexcil AiMeD and top representatives from Indian medical device industry. Deliberations took place on important topics such as development of medical device regulation, third party medical certifications system, quality standards and GMP system in countries, strategies and challenges for global drug development, among others. ]]> https://biospectrumindia.com/news/22/8758/tpg-general-atlantic-to-bid-for-fortis-healthcare-srl.html https://biospectrumindia.com/news/22/8758/tpg-general-atlantic-to-bid-for-fortis-healthcare-srl.html Thu, 04 May 2017 16:10:00 +0530 Private equity firms TPG Capital Inc and General Atlantic Pvt. Ltd have formed a consortium to acquire a controlling stake in Fortis Healthcare Ltd and its subsidiary SRL Diagnostics Pvt. Ltd. The transaction would involve TPG and General Atlantic acquiring a 26% stake in Fortis Healthcare, which would trigger an open offer, going by Indian regulations. The deal could value Fortis at about Rs 12,000 crore, a shade above its current market cap at Rs 11,444 crore. Additionally, SRL could be valued at Rs 4,500-5,000 crore. It seems that Daiichi Sankyo has given its consent to proceed with the Fortis deal. Both PE firms and the sellers have taken all parties, including Daiichi Sankyo, into confidence. TPG, which has been driving this transaction, also seems comfortable with the legalities. Daiichi Sankyo and the Singh brothers have been locked in a court battle over the sale of Ranbaxy Laboratories since 2013 and the Japanese pharma giant was trying to stop the sale of Fortis Healthcare on the grounds that it would hinder its ability to enforce an arbitration award. ]]> https://biospectrumindia.com/news/22/8753/immediate-reporting-of-coronary-stent-shortage.html https://biospectrumindia.com/news/22/8753/immediate-reporting-of-coronary-stent-shortage.html Wed, 03 May 2017 16:23:25 +0530 Hardening its stand against pharmaceutical giants Abbott, Medtronic and Boston Scientific, the National Pharmaceutical Pricing Authority has asked hospitals, doctors and patients at large to report on any shortage of coronary stents after these companies had tried to withdraw from India last month. The authority requested people to report back shortage of Medtronic’s Resolute Onyx Zotarolimus Eluting Coronary Stent System, Abbott’s Absorb GTI-Bioresorbable Vascular Scaffold (BVS) and Xience Alpine Medical Device, and Boston Scientific’s SYNERGY monorail Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus PREMIER Everolimus- Eluting Coronary Stent System. These multinational companies had applied to withdraw their apparently latest generation coronary stents from the Indian market with Abbott leading the pack on April 22. Soon after the government had imposed price cap on stents, the companies had called it commercially unviable to bring the latest technology to India. However, on April 26, the NPPA denied Abbott and Medtronic permission to withdraw their stents from the country, stating the application was not duly signed. The NPPA had also ordered the companies, under the Drug Prices Control Order 2013, to ensure a steady supply of the stents in question and submit weekly reports on their availability. ]]> https://biospectrumindia.com/news/22/8735/foamix-pharmaceuticals-ltd-completed-phase-3-trials-for-fmx101-.html https://biospectrumindia.com/news/22/8735/foamix-pharmaceuticals-ltd-completed-phase-3-trials-for-fmx101-.html Tue, 02 May 2017 16:10:20 +0530 Foamix Pharmaceuticals Ltd., a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, announced results from additional analysis of the recently completed Phase 3 pivotal trials for its lead candidate FMX101 in moderate to severe acne. Foamix has reviewed its regulatory strategy for FMX101.  Based on the knowledge gained from the results of the first two pivotal trials (Trials 04 and 05), the company intends to conduct a third U.S. Phase 3 Trial, beginning mid-year, in patients with moderate to severe acne.  If the results will be positive, this trial is expected to form the basis for a New Drug Application (NDA) which the company plans to submit in the second half of 2018. If approved, FMX101 will be the first FDA-approved topical minocycline treatment for moderate-to-severe acne, a skin disorder that affects millions of people with potentially significant psychological and social implications. Foamix is also developing FMX103, minocycline foam 1.5%, a topical foam formulation of minocycline for the treatment of moderate-to-severe papulopustular rosacea. ]]> https://biospectrumindia.com/news/22/8729/mpeg-la-invites-crispr-cas9-patents-to-be-pooled-in-a-one-stop-license.html https://biospectrumindia.com/news/22/8729/mpeg-la-invites-crispr-cas9-patents-to-be-pooled-in-a-one-stop-license.html Tue, 02 May 2017 12:36:02 +0530 World licensing leader MPEG LA, LLC invited holders of CRISPR-Cas9 patents to participate in the creation of a global CRISPR-Cas9 Joint Licensing Platform that will make their groundbreaking technologies widely accessible.  Pooling the foundational CRISPR patent rights under a single nonexclusive, cost-effective, transparent license will allow the market to focus on the creation of new products and therapies that accelerate and expand CRISPR’s deployment. Just as MPEG LA’s pioneering efforts to manage licensing overhead and mitigate litigation risk helped assure the success of digital video in the consumer electronics industry, the CRISPR-Cas9 Joint Licensing Platform can do the same for healthcare and other biotechnology industries but with an impact far more profound.  At the same time, both foundational and other patent owners would be rewarded for their inventions from their fair share of reasonable royalties from the pool and incentivized to develop more. As a voluntary market-based business solution that balances access with incentive, an independently managed pool offers the best hope for addressing market and public interests in a way that will unleash CRISPR’s full potential for the benefit of humanity.  MPEG LA welcomes CRISPR-Cas9 patent holders who would like to participate in this ground floor opportunity to create a Joint Licensing Platform to visit http://www.mpegla.com/main/pid/CRISPR/default.aspx for more information, including terms and procedures governing patent submissions and eligibility. At least one eligible patent is necessary to participate in the license development process, and eligibility will be determined by MPEG LA at no cost to submitters. Interested parties are asked to make their initial patent submissions by June 30, 2017. Although submissions will continue to be accepted in order to assure that the joint license includes as much relevant intellectual property as possible for the benefit of the market, those who submit patents by that date and are found eligible will be invited to attend an initial meeting with other eligible patent rights holders to explore the potential for joint terms on which the CRISPR-Cas9 Joint Licensing Platform may be offered. Except for confidentiality, participation is without obligation or commitment, including attendance at future meetings, until such time as an eligible patent holder may decide to join the Joint Licensing Platform. ]]> https://biospectrumindia.com/news/22/8724/60-medicines-declared-substandard-by-drug-regulator-.html https://biospectrumindia.com/news/22/8724/60-medicines-declared-substandard-by-drug-regulator-.html Mon, 01 May 2017 11:26:38 +0530 Some of the most common pills like Combiflam and D-Cold consumed in India has been recently decalared as sub-standard by Indian drug regulator, CDSCO.  Specific batches of 60 drugs have failed quality tests in sample-based screening of Central Drugs Standard Control Organization (CDSCO). Both the batches of Combiflam and D-Cold tablets failed the test because of "disintegration" issues. Reason of failure for Cetrizine was "related substances". Ofloxacine and ciprofloxacine failed "assay" which is a quantitative tests for ingredients. A gentamicine injection failed the test for "particulate matter". Pantoprazo failed the test for "dissolution".  The 60 drugs which have found their way into the 'substandard' list are as below: Stromix A 75 (Clopidogrel & Aspirin Capsules) Nifesta – 10 (Nefidipine Sustained Release Tablets I.P.) Primaquine Tablet I.P. 2.5 mg Macmika 100 (Amikacin Sulphate Injection I.P. 2 ml) Onset (Ondansetron Injection I.P.) Amoxycillin & Cloxacillin Capsules Micarti – DS (Glucosamine Capsules 500 mg) Clobetasol Propionate Cream B.P. 10 gms Gentamicin Injection I.P. Ceftriaxone Injection I.P. Injection of Etofylline & Theophylline Nkacin – 500 (Amikacin Sulphate Injection I.P.) Cefuroxime Axetil Tablets I.P. 500 mg Metronidazole Tablets IP 200 mg Fungal Diastase (1:1200)+Pepsin (1:3000)/15ml (Nutozyme Syrup) Cetirizine Tablets IP (Ceriz Tablets) Ofloxacin Dispersible Tablets 100mg (Oflox-100 DT) Paracetamol, Caffeine anhydrous and Phenylephrine HCl Tablets (New D Cold Total Tablets) Pantoprazole Gastro-Resistant Tablets IP (Panza- 40 Tablets) Atenolol Tablets IP (Tenol-50 Tablets) Calcium Carbonate with Vitamin D3 Tablets (Osocal- 500 Tablets) Thiocolchicoside and Etoricoxib Tablets (EtoxtanMR Tablets) Cefixime and Ofloxacin Tablets (Matcef-o Tablets) Erythromycin Stearate Tablets IP 500mg Combiflam (Ibuprofen and Paracetamol Tablets) Etoril-5 (Ramipril Tablets I.P. 5mg) Stromix A 75 (Clopidogrel & Aspirin Capsules 75mg+75mg) Lactulose Solution USP 10g/15ml  Lactulose Solution USP 10g/15ml  Cadilose (Lactulose Solution USP) Lactulose Solution USP 10g/15ml Lactomed ( Lactulose Solution USP 10g) Ciprofloxacin Tablets IP 250mg X’ tor-10 (Atorvastatin Calcium) Calcium Carbonate with Vitamin D3 Tablets Doxylamine Succinate Tablets Doxylamine Succinate Tablets Doxylamine Succinate Tablets Theo - AsthalinTablets Lomotin Tablets Pyra Tablets Acloway – P Tablets Carbamal - 200 Tablets Elkaf – CM Expectorant Ibuprofen Tablets Zinc Sulphate Dispersible Tablets Cipro - 500 Tablets Elkaf – CM Expectorant Fexonil - 180 Tablets Doxylamine Succinate Tablets Tramaford Tablets Zinc Sulphate Dispersible Tablets Aricepo – 200 Tablets Riptin – 25 Tablets Ferrous Sulphate & Folic Acid Tablets (LARGE) Iron Tablets with Folic Acid  Ferrous Sulphate & Folic Acid Tablets Ceftrixone & Sulbactum Injections Iron Tablets with Folic Acid  Ferrous Sulphate & Folic Acid Tablets (LARGE)     ]]> https://biospectrumindia.com/news/22/8715/bayer-receives-fda-approval-for-stivarga.html https://biospectrumindia.com/news/22/8715/bayer-receives-fda-approval-for-stivarga.html Fri, 28 Apr 2017 15:54:37 +0530 Bayer announced that the U.S. Food and Drug Administration (FDA) approved Stivarga® (regorafenib) tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar® (sorafenib). Stivarga is the first and only treatment to demonstrate significant improvement in overall survival in second-line HCC patients. Stivarga is an oral inhibitor of multiple kinases involved in normal cellular functioning and in pathological processes such as oncogenesis, tumor angiogenesis, metastasis and tumor immunity. The approval of Stivarga in liver cancer marks the third time that this therapy has been granted FDA approval on a priority basis. The FDA granted Fast Track designation to Stivarga in this indication, which is an expedited program designed to facilitate development and review of drugs to address unmet medical need in the treatment of a serious or life-threatening condition. The FDA also granted Orphan Drug Designation (ODD) to Stivarga in HCC. The ODD program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders. Additional regulatory filings for Stivarga in HCC are under review in countries around the world, including the EU, Japan and China. Decisions in the EU and Japan are expected later in this year. ]]> https://biospectrumindia.com/news/22/8694/fda-warning-to-14-companies-for-false-claims.html https://biospectrumindia.com/news/22/8694/fda-warning-to-14-companies-for-false-claims.html Thu, 27 Apr 2017 16:23:04 +0530 The U.S. Food and Drug Administration has issued warning letters to 14 companies based out of U.S., who are selling more than 65 products illegally making false claims to prevent, diagnose, treat, or cure cancer. The products are promoted and sold most commonly on the company websites and social media platforms without the approval of FDA. Promoting or selling products claiming to diagnose, treat, prevent, alleviate, or cure the diseases without first demonstrating to FDA that they are safe and effective for their labeled use is a breach of the Federal Food, Drug, and Cosmetic Act. The FDA has demanded the 14 companies to provide their answers for correcting the violation, while failing to do so may lead to legal action, seizing products, injunction, and/or criminal suit. In the past 10 years, more than 90 letters have been issued by FDA warning companies that market hundreds of fake products in their stores, websites, and on social media sites for cancer cure claims, as a part of FDA’s efforts to safeguard consumers from frauds related to cancer health. ]]> https://biospectrumindia.com/news/22/8675/cphi-expert-calls-for-anda-approvals-to-be-reduced-by-two-thirds-in-order-to-lower-drug-costs.html https://biospectrumindia.com/news/22/8675/cphi-expert-calls-for-anda-approvals-to-be-reduced-by-two-thirds-in-order-to-lower-drug-costs.html Thu, 27 Apr 2017 14:39:05 +0530 Girish Malhotra, President of EPCOT International, and CPhI Worldwide Annual Industry Report member, discusses the necessity of time reduction for ANDA approvals, arguing that if the current approval time can be reduced from ten months to three months, drug costs will decrease.  He said, “In order to decrease the time for ANDA approvals, there are three main challenges to overcome. Currently, it takes up to four review cycles to approve an ANDA, and the first and foremost challenge is with submission completeness.” “On average, it takes the FDA reviewing team 45 days to determine application completeness. This time can potentially be reduced to 15 days if the FDA modifies their review process. Last month the Pre-ANDA program was proposed, a first-step Quality by Analysis (QbA) implementation in the application filing process. Although applications for every product are different in content, the information filing requirements are essentially the same. Workshops that train the FDA industry staff to become familiarized with the application requirements would allow the Pre-ANDA program to be implemented efficiently”, Malhotra explained. “If the approval process were lowered to three months, the need for priority review would likely disappear entirely”, he added Lastly, the 90-day frame can be further broken down into three segments. The FDA will complete the initial review within 15 days and companies would then have 30 days to respond to FDA’s requirements. Following this, the FDA will then have 45 days to review the application and return to the company with a final proposal. Companies that cannot fulfill obligations after the 15-day FDA review combined with the 30-day deficiency completion will be required to start the process over. This will encourage companies to ensure that they provide the best application possible.     ]]> https://biospectrumindia.com/news/22/126/lok-sabha-passes-hiv-and-aids-prevention-and-control-bill-2017.html https://biospectrumindia.com/news/22/126/lok-sabha-passes-hiv-and-aids-prevention-and-control-bill-2017.html Thu, 20 Apr 2017 11:20:00 +0530 The Lok Sabha on recently passed a crucial bill that ensures equal rights to the people affected by HIV and AIDS in terms of getting treatment, jobs or admissions to educational institutions. Moving the Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS) (Prevention and Control) Bill, 2017 for passage, health minister JP Nadda said "the government stood for free treatment to HIV patients. The "historic" and "people centric" legislation will strengthen rights of people infected with HIV. "Whosoever does not adhere to the provisions of the bill, will be penalised. Civil and criminal proceedings will be launched against such persons", Nadda said, adding that action would also be taken against those who attempted to block the implementation of the bill. Every HIV infected or affected person below the age of 18 years has the right to reside in a shared household and enjoy the facilities of the household", Nadda said. This bill prohibits any individual from publishing information or advocating feelings of hatred against HIV positive persons and those living with them. Nadda said the government will also promote research to check the spread of HIV virus and come out with aggressive strategies, especially in high risk areas. ]]>