MedTech sector urges Govt. to expedite regulatory reforms for the sector

Medical device industry urges Ministry of Health & Family Welfare to expedite PMO’s decisions on regulatory reforms for the sector

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Mr Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Manufacturers (AiMeD)

AiMeD, the apex body of Indian medical device manufacturers, has urged the Ministry of Health and Family Welfare for speedy implementation of the decision taken three months ago by the Prime Minister's Office to initiate wide ranging regulatory reforms for medical device sector in order to boost domestic manufacturing and investment in the sector as well as to ensure enhanced healthcare security for common Indian citizens.

PMO has specifically deliberated on the need to bring a new legislation for medical device industry as well other regulatory reforms including the need to delink medical device sector from the pharmaceutical industry.

Currently, the medical devices sector is governed by the Drugs and Cosmetics Act, 1940, the same Act which also governs pharmaceutical sector in the country, an absurd legacy which has been impeding the growth of and investment in medical device sector. However, despite three months of having elapsed since the PMO's decision to speed up regulatory reforms, there appears to be little movement on its directives.

"We are extremely thankful to the Prime Minister's office for recognizing the need to speed up regulatory reforms for the medical device industry. Early implementation of PMO's directives is in the interest of the country, enhanced healthcare security for millions of Indians and for boosting domestic manufacturing and investment in medical device sector," said Mr Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Manufacturers (AiMeD).

Reforms are also needed to lower the huge burden of import dependency in this critical sector, added Mr Nath.

 

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