The apex body of the Indian medical device manufacturers, AiMeD, has asked the Health Ministry 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 to boost domestic manufacturing and investment in the sector.
The 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, said Rajiv Nath, Forum Coordinator of AiMeD here.
Reforms are also needed to lower the huge burden of import dependency in this critical sector, added Nath.
However, despite three months after the PMO's decision to speed up regulatory reforms, there appears to be little movement on its directives. 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, the expert added.
To boost domestic manufacturing and investment, increase productivity and to minimise import dependency in this critical healthcare sector, the medical device industry has been specifically urging a separate Medical Device Regulatory Act and separate Rules rather than ongoing amendment to D&C Act, 1940. It is also seeking a separate department for medical devices to act as facilitator and regulator for medical devices.
This is not only in the interest of patient safety but also to give clarity to confused apprehensive investors who are today reluctant to invest in this huge sector. We cannot move from move from 70% import dependency to self sufficiency and unleash the huge export potential appropriate regulatory reforms are undertaken urgently,” pointed out Nath.
The problem for domestic manufacturers has been aggravated by pseudo manufacturers who are basically importers and are passing off themselves as manufacturer by simply labeling imported products. AiMeD wants a clearer definition and clear distinction between manufacturers and traders, he explained.