Centre likely to introduce Drugs, Medical Devices & Cosmetics Bill 2023 in House

| | New Delhi
  • 0

Centre likely to introduce Drugs, Medical Devices & Cosmetics Bill 2023 in House

Tuesday, 12 December 2023 | Pioneer News Service | New Delhi

The Central Government is likely to introduce the Drugs, Medical Devices and Cosmetics Bill, 2023 in the ongoing session of Parliament with an aim to repeal the 80-year-old Drugs and Cosmetics Act, 1940 and introduce a new law that amends and consolidates the regulatory requirements for the import, manufacture, distribution and sale of drugs, medical devices, and cosmetics in the country.

The proposed law will have an entirely separate section to prescribe regulatory norms for medical devices. It will not only result in a separate set of rules for medical devices but also provide for a separate team of regulatory officials with specific skill sets to approve and monitor all types of medical devices.

The new law is expected to help advance clinical trials of new drugs and clinical investigation of investigational medical devices in the country. Regulation of e-pharmacies will be another important feature of the proposed law.

Incidentally, the Bill was listed to be introduced in the Monsoon session of Parliament but had to be withheld due to opposition from the medical device manufacturers.

The Association of Indian Medical Device Industry (AIMED) had complained that the Bill does not propose an independent regulatory regime for medical devices but continues with the current practice of treating devices as drugs with the same punitive actions for errant manufacturers.

The medical device industry had also questioned the proposal to have a central medical device testing laboratory by stating that one laboratory in a single location to do biocompatibility testing, animal studies and testing, mechanical and chemical testing or electronic component and product testing for over 6,000 types of medical devices may not be practical.

Sunday Edition

Lighting up the Holiday Spirit

22 December 2024 | Abhi Singhal | Agenda

Unwrapping Festive Flavours

22 December 2024 | Team Agenda | Agenda

Plates that teleport to Iran

22 December 2024 | Team Agenda | Agenda

Winter Wonderland

22 December 2024 | Team Agenda | Agenda

Savour the Spirit of Christmas!

22 December 2024 | Divya Bhatia | Agenda

A Paw-some Celebration of Pet Love

22 December 2024 | SAKSHI PRIYA | Agenda