According to AiMeD, it will boost domestic manufacturing and investment in the sector
Association of Indian Medical Device Manufacturers (AiMeD), the apex body of Indian medical device manufacturers, has urged the Ministry of Health and Family Welfare (MoHFW) for speedy implementation of the decision taken three months ago by the Prime Minister’s Office (PMO) to initiate wide ranging regulatory reforms for medical device sector. It will 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 devices industry as well other regulatory reforms including the need to de-link medical device sector from the pharmaceutical industry.
“We are thankful to the PMO for recognising the need to speed up regulatory reforms for the medical devices 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 Rajiv Nath, Forum Coordinator, AiMeD.
Reforms are also needed to lower the huge burden of import dependency in this critical sector, added Nath. In order to boost domestic manufacturing and investment, increase productivity and to minimise import dependency, AiMeD has urged for a separate Medical Device Regulatory Act and separate rules rather than ongoing amendment to D&C Act, 1940, a separate department for medical devices to act as facilitator and regulator for medical devices and strict ethical marketing regime code.
“We are seeking ‘Voluntary Demonstration of Compliance via 3rd Party Certification’ e.g. ICMED Certification to gain Respect for India and trust for Indian Medical Devices and Risk Proportionate Penal controls for this engineering industry,” said Nath.
The medical devices industry hopes that MoH&FW will speedily push the PMO’s agenda of enhanced Patient Safety and Make in India and adhere to defined timelines for tabling the Bill to regulate quality of medical devices by this winter session.
EH News Bureau