The biopharma market in India is growing at an annual
growth rate of 15 percent. By 2020, the market is projected to be worth
over
938,688 cr ($200 bn), driven largely by a shift in usage from
conventional drugs to biopharma products, the relatively high cost of
biopharma products, the launch of biosimilars and a new generation of
biotherapeutics.
This was stated by Ashok Kumar, secretary, Department of
Pharmaceuticals, Ministry of Chemicals and Fertilisers, Government of
India, while inaugurating the National Convention on Biopharma,
organized by the Department of Pharmaceuticals (DoP) and Federation of
Indian Chambers of Commerce and Industries (FICCI) in association with
the Department of Biotechnology (DBT) and the Association of
Biotechnology Led Enterprises (ABLE) in New
Delhi on July 12, 2010. On the occasion, Ashok Kumar released the
'Vision 2020' document titled 'Leadership in Affordable Therapeutic
Products: A BioPharma Strategy for India', prepared by
PricewaterhouseCoopers and ABLE.
The report has exclusively quoted the BioSpectrum-ABLE Top 20 Biotech
Survey, which was published in the June 2010 issue of BioSpectrum
magazine. The report has used BioSpectrum data for providing the
information on overall market size, rankings of the companies and other
relevant figures.
The 'Vision 2020' document spells out the challenges before the
biopharma industry and suggests key action areas for the medium-term
and long-term.
The report states that if India wants to become the world leading
provider of affordable biopharma products by 2020, it cannot simply
count on biosimilars and vaccines; it should also become a source of
innovation. More specifically, it should aim to have at least 10
original biologics on the local market and at least two on the global
market by 2020. The report identifies five long-term (2020) initiatives
and recommends that the government should make an additional
4,694
crore ($1 bn) fund available over the next 10 years to facilitate the
growth.
Ashok Kumar said, “The Government proposes to set up a
3,000 cr
venture capital fund for giving a fillip to drug discovery and
strengthening the pharma infrastructure in the country. The National
Institute of Public Finance and Policy (NIPFP) is set to finalize the
bid document and the expression of interest for setting up the fund
will be issued this month.�
He further added that the government had issued an expression of
interest for technical and financial bids for the selection of a global
level consultant (GLC) for preparation of a detailed project report
(DPR) for developing India as a drug discovery and pharma innovation
hub by 2020.
He said that the government is willing to look at the industry's demand
for a single regulatory authority to do away with multiple regulatory
bodies. At the same time, priority was being accorded to building the
capacity of IP offices for approval and rejection of patents. He
emphasized the need to create a talent pool of graduates in the
biopharma sector, for which short-term courses that expose the
graduates to the realities of the workplace, could be started by the
National Institute of Pharmaceutical Education & Research (NIPER).
Dr S Natesh, additional secretary, Department of Biotechnology (DBT),
highlighted that India needs to move from a phase of manufacturing to
path of discovery and innovation.
Dr TS Rao, advisor of DBT highlighted the lack of availability of
GCP-trained manpower in healthcare sector. He raised concern for the
proper utilization of the already existing facilities set up by
government and cautioned that careful need assessment is required for
facilities to be effective.
Distinguished persons from the industry and academia participated in
the event. The convention had different sessions on manufacturing,
infrastructure and HRD, challenges and opportunities in biopharma
industry and also a session on the regulations for biopharma industry.
Agricultural scientists call for revoking moratorium on Bt brinjal
A workshop for scientists titled, 'The impasse caused by
the Bt brinjal moratorium', was organized by the Foundation for
Biotechnology Awareness and Education (FBAE) on July 28, 2010, in New
Delhi. As part of the workshop, there was an open discussion on the
impact of Bt brinjal moratorium on R&D of genetically engineered
crop in India and the need to revoke the moratorium.
Prominent agri experts including Dr Shanthu Shantharam, executive
director, Association of Biotechnology Led Enterprises (ABLE); Dr TM
Manjunath, consultant of agribiotechnology and IPM, and former
director, Monsanto Research Center; Prof C Kameshwar Rao,
consultant-biotechnology and medicinal plants, Foundation for
Biotechnology Awareness and Education; Dr P Balasubramanian, former
head, Department of Biotechnology, Center for Plant Molecular Biology;
and Dr Seetharam Annadana, technology lead -Vegetables, Syngenta India
participated in the workshop.
The workshop concluded that the Ministry of Environment and Forests
(MoEF) was strongly influenced by those opposed to agricultural biotech
than by credible, critical and balanced scientific judgments. There was
a consensus among the scientists that the seven city public
consultation by MoEF did not provide an adequate opportunity for the
scientific community to voice its concerns.
A petition to the ministries and concerned departments of the
government was also drafted after considering the opinions of all the
participants. The memorandum was submitted to Prime Minister,
Ministries for Agriculture, Science and Technology, Human Resource
Development, Environment and Forests, Health and Family Welfare,
Commerce, and also the Indian Council for Agricultural Research,
Department of Biotechnology, Department of Science and Technology,
Department of Scientific and Industrial Research, Indian Council for
Medical Research and Council for Scientific and Industrial Research.
The scientists also called upon various government regulatory agencies
to step in and support the demand of ending the moratorium at the
earliest. They also emphasized on public awareness as an important
aspect of the technology development.
India
contributes 20% to generics market
Indian pharma market has registered
38,692 crore ($8.25 bn) in 2009
and has enjoyed double-digit growth in the past five years, peaking at
25 percent in 2007. The strong growth registered by the Indian economy
has helped to drive its pharma market and industry. India's expanding
middle class, with growing affordability and greater access to
healthcare are the main drivers for the current growth of the industry
and economy.
As per PriceWaterhouseCoopers report, finished generics supplied from
India account for 20 percent of the global generics market. It is
estimated that 70 percent of the patients belong to 87 developing
countries and received drugs produced in India and distributed by the
UNICEF, International Dispensary Association, the Global Fund and the
Clinton Foundation.
Biocon
signs supply pact with Optimer
Biocon has signed a long-term agreement with US biopharma company,
Optimer Pharmaceuticals, for the commercial manufacturing of active
pharma ingredient, OPT 80.
The drug is among a new class of macrocyclic antibiotics and is being
developed by Optimer to treat serious colon infections such as
Clostridium difficile infection and is expected to be commercialized
soon. For the last five years, Biocon has been an important partner in
Optimer's Opt 80 development program and will continue this
relationship with the manufacturing and supply of this product once the
drug gets the approval.
Antibiotics
market registers 3,250 cr
Changing trends and development in healthcare infrastructure make way
for wide range of new antibiotic entrants in the Indian pharma market.
According to a report by Datamonitor titled, 'High-end antibiotics
usage in India,' the market for high-end antibiotics in Indian
hospitals registers
3,250 crore ($686 mn) in FY 2010, having shown an
year-on-year growth of 49.8 percent. The market is estimated to grow to
about
8,725 crore ($1,841 mn) by FY 2015, posting a CAGR of 21.8
percent.
Datamonitor noted that as healthcare infrastructure improves in India
and well-established hospital chains expand their presence across the
country, the market for hospital antibiotics is likely to widen.
Although the anti-bacterial market in India is currently dominated by
generics, newer antibiotics are constantly being sought after.
Serum launches
indigenous intra-nasal swine flu vaccine Nasovac
Serum Institute of India (SII), one of the largest
vaccine manufacturers in India, has launched its indigenously developed
intra-nasal H1N1 vaccine under the brand name Nasovac on July 14, 2010,
in Mumbai. SII thus became the third manufacturer in the country to
market vaccines against swine flu, the other two companies being Zydus
Cadila (VaxiFlu-S) and Sanofi-aventis (whose vaccines were imported by
the Indian government).
Speaking at the launch of the product Adar Poonawalla, executive
director of SII, said, “The fear of the public about the pandemic last
year was a challenge for our healthcare system. In India, there are
around 150,000 child deaths due to vaccine preventable diseases.
According to the World Health Organization (WHO), even the African
nations and other third world countries have better immunization
programs than India. The Government of India and the Ministry of
Healthcare attribute this to lack of resources and funds. India as a
nation is not bothered about healthcare.�
A Live attenuated influenza vaccine (LAIV), Nasovac, is a single dose
vaccine fitted at the top of the syringe and around 0.25 ml is to be
administered in each nostril, mimicking the path followed by the virus
to enter the body. The vial consists of five doses. Except for pregnant
women, any individual above the age of three years can use this
intra-nasal vaccine. On the other hand, an injectable vaccine can be
administered only for individuals 18 years and above.
LAIV has the upper hand over an inactivated-based vaccine in many
respects. Dr Prasad Kulkarni, additional medical director of SII, said,
“In the case of a LAIV, the production capacity is 10 times higher than
inactivated-based vaccines, making this suitable during the times of a
pandemic. The production cost is much lower and this enables us to
produce larger capacities of the vaccine. Plus the simplicity of the
nasal route is an added benefit.�
With the outbreak of swine flu pandemic last year, Serum Institute was
one among the three Indian vaccine makers-along with Bharat Biotech and
Panacea Biotec-provided with the swine flu virus strains by the WHO to
develop the vaccine. It was indeed a battle against time for the team.
A BioSafety Level 2 (BSL 2) facility was set up a few weeks post the
outbreak was officially termed as a pandemic.
The seed virus was supplied by the WHO to SII and phase I trials of the
Nasovac was conducted on 50 healthy people, post approval by the Indian
regulator, the Drug Controller General of India (DCGI), around 330
volunteers (both adults and children) were roped in for phase II trial.
According to FDA norms, trials cannot be conducted on pregnant women,
hence the vaccine was tested on pregnant rats to prove its safety and
efficacy.
The product is now priced at half the price of similar vaccines
marketed by Indian and foreign companies. “The price of a single dose
of this vaccine will cost
160 ($3.42) and is now available at retail
outlets across all cities in India. As of now, we will market the
product in India,� said Poonawalla. The company is slated to receive
the WHO pre-qualification in a few months, subsequent to which it
intends to market the product in 100 countries.
DBT all
set to strengthen biotech R&D in NE states
While initiating a special program for the north eastern states, the
Department of Biotechnology (DBT), Government of India, has invited
proposals in the field of basic and applied biotechnology from Indian
scientists, working on a regular basis in universities, academic,
medical or research institutions in any of the north eastern states of
India in collaboration with scientists from other national
institutions.
The scientists should be working in any of the broad areas of health
sciences, agricultural sciences, veterinary sciences, pharmaceutical
sciences, biomedical engineering, bioinformatics, food and nutrition,
healthcare including alternative medicine, nanotechnology and
environmental biotechnology.
The joint R&D programs may involve partners from recognized private
institutions as well as NGOs. The program aims to help establish and
strengthen R&D activities in the north eastern states like
Arunachal Pradesh, Assam, Manipur, Meghalaya, Mizoram, Nagaland, Sikkim
and Tripura; through joint ventures.
The proposals will be evaluated by the committee of experts. The
approved projects would be initially funded for a period of three years
that may be extended based on the performance review. The information
in the application should be clearly given in two parts - one,
pertaining to the parent institution in the north eastern region and
the other regarding the collaborating institutions. The last date for
sending the proposals as per the DBT format has been kept as August 9,
2010.