Stakeholders express dismay as Centre readies to regulate medical devices alongside drugs

Concerned groups express dismay over proposed New Drugs, Cosmetics and Medical Device Bill, 2023, citing inadequate addressing of key issues and lack of external input.

NEW DELHI

Patient groups, healthcare providers, and manufacturers associations have expressed their dismay as the Centre prepares to table the New Drugs, Cosmetics and Medical Device Bill, 2023 in Parliament, without adequately addressing their concerns, the concerned groups said in a statement issued on December 16.

While the proposed legislation is aimed at regulating the medical device sector, industry leaders argue that key issues such as regulatory complexities, the potential impact on innovation, and the need for a conducive business environment have yet to be adequately assured by redressal in the proposed Bill.

“Earlier industry stakeholders voiced their concern that their input has been overlooked despite intervention by the Health Ministry,” Association of Indian Medical Device Industry Forum coordinator Rajiv Nath said.

He added that no committee was formed to review the different tenets of the Bill on a clause-by-clause discussion to align it or as suggested to use earlier separate Bill drafted by NITI Aayog in 2019.

“The need of the hour is a progressive modern separate law for addressing patient safety concerns,” Mr. Nath said, adding that by keeping a chapter of penalties and punitive actions common with drugs, India is only reviving the Inspector Raj.

The group has noted that the proposed Bill is old wine in a new bottle as only the label is getting changed.