Medical device makers seek withdrawal of new Drugs, Medical Device and Cosmetics Bill 2023

Domestic medical device makers oppose Govt’s proposed law and a recent order allowing import of second-hand high-value medical devices for re-use in India

Indian medical device makers have asked the Union Health Ministry to withdraw the new Drugs, Medical Device and Cosmetics Bill 2023, arguing that the proposed legislation favoured multinational companies instead of the domestic ones besides being contradictory to the National Medical Device Policy.

Ten associations representing indigenous manufacturers requested the ministry to recall the draft bill and hold wider consultations before preparing a fresh draft, preferably creating two separate laws for drugs and medical devices as suggested by a Parliamentary panel.

They also pointed out that while the government encouraged domestic manufacturers to “reduce import dependency and become self-reliant”, there was an order permitting import of 50 high value medical devices for “reuse in India”.

The local manufacturers made their appeal at a time when the health ministry for the first time hosted an expo on Indian medical device industry on the sidelines of the G20 Health Ministers meeting at Gandhinagar.

Inaugurating the show on Thursday, the Union Health Minister Mansukh Mandaviya said “our goal is to become self-reliant in the medical device sector and reduce our import dependency.” The Centre permitted 100 per cent FDI under automatic route and a production linked incentive scheme for the sector.

Such policy measures, according to industry officials, goes against an office memorandum issued by the Union Environment Ministry in June allowing import of 50 medical devices for re-use.

“The decision to permit the import of pre-owned medical devices was in contravention to the National Medical Device Policy-2023 that seeks to make our country not only Atma Nirbhar in medical devices but also the global leader. The OM was a regressive step,” said Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD)

AiMeD and nine other bodies have appealed to the minister not only to cancel the order, but also to recall the draft bill – released last year – alleging that the legislation favoured multinational companies, which misled those who drafted the legislation.

They sought one more round of review by a fresh committee chaired by an expert from the Indian Council of Medical Research or the Department of Science and Technology or the Department of Biotechnology. Following such a consultation, the draft should be revised before it was placed in the Parliament, Nath said.

The industry associations highlighted reports of the Parliamentary Standing Committee of Health and Family Welfare, which recommended having two separate laws on drugs and cosmetics, and medical devices, rather than clubbing the both in a single one.