Wednesday, 19 September 2018

Industry leaders from pharma and medical devices sectors raise key demands with the Government

16 February 2018 | News

The CEOs requested the government to separate medical devices from drugs through a new Act, in accordance with global best practices.

A delegation of key industry leaders from the pharma and medical devices sectors highlighted their pressing demands and concerns to the Union minister of Chemicals & Fertilizers Mr. Ananth Kumar at the third edition of India Pharma and Medical Device 2018 that is being held in Bengaluru from Feb 15-17, 2018. The demands, if met, will give the industries a boost and make India a world leader in the pharmaceuticals and medical devices.

Five Key Demands of medical device makers:

  • Continue to adhere to globally harmonized standards (ISO and IEC) for patient safety and development of the sector
  • Medical Devices should be separated from Drugs through a new Act
  • should come up with a medical device policy for inclusive growth of the sector
  • Early decision should be taken on Trade Margin Rationalization
  • Current price control mechanism should be altered to take “Value Based Healthcare” approach, focusing on long term health outcome and innovation

While congratulating the Government on implementation of New Medical Devices Rules which will help ease of doing business, eminent Medtech CEOs, including those from leading indigenous manufacturers, asked that ICMED-type India-only standards should be stopped and India must abide by globally harmonized standards like ISO and IEC which will allow Indian firms to export medical devices and ensure safety of Indian patients.

The CEOs requested the government to separate medical devices from drugs through a new Act, in accordance with global best practices. They said that the Government's move not to increase import duty is a positive step towards maintaining affordability of the Indian patients in a highly out-of-pocket scenario.

“We request that the Government draft a Medical Device Policy for inclusive growth of the sector,” they added, asking for Trade Margin Rationalization to ensure affordable Medical Devices for all and an early decision regarding the matter to end business and strategic uncertainty. The industry leaders requested the Government to alter the current price control mechanism and take the approach of “Value Based Healthcare” by focusing on long term health outcome and innovation.

The CEOs said they eagerly await the swift implementation of the Ayushman Bharat insurance schems, as it will give a boost to India’s healthcare infrastructure.

The leaders of the pharma industry met the minister and asked for a differentiated GST rate for pharma companies. “The country urgently needs revival of domestic API industry to reduce dependence on imports. The government needs to encourage innovation and ‘Make in india’ to promote Indian manufactured drugs,” the CEOs said. The also asked for rationalization of regulators in the pharma sector and greater transparency in the working of NPPA.

 Ten Demands of Pharma Industry:

  • Differentiated GST rate for pharma companies
  • Retrospective pricing for NLEM drugs
  • Relook at pricing of injectables
  • Revival of domestic API industry to reduce dependence on imports
  • Promote Indian-manufactured drugs
  • Rationalization of regulators in pharma sector
  • Greater transparency in NPPA working
  • Address implementation issues in DPCO 2013
  • Widening of scope of Govt. power to review as per Para 31 of DPLCO 2013
  • Create level playing field

The pharma industry leaders also asked for a relook at the pricing of injectables and retrospective for NLEM drugs (applicable to batches manufactured after 15 days of order issue).

They strongly urged the Government to create a level playing field such as in the case of testing fee for products exported to China as compared to Chinese products.

A host of dignitaries are present at the mega-event, including 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.

Themed around ‘Affordable, Quality Healthcare, 'the three-day conference has back to back sessions with over 90 industry leaders as speakers. 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.

The delegation of CEOs that met the Minister Mr. Ananth Kumar was led by Mr. Sashi Kumar, MD of Phoenix Medical Systems who is Co-Chair, FICCI Medical Device Forum and; Probir Das, MD, Terumo India, who is Chair, FICCI Medical Devices Forum; as well as Mr. S Sridhar, MD of Pfizer India, who is Co-Chair, FICCI Pharma Committee.

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