The central government is likely to introduce the Drugs, Medical Devices and Cosmetics Bill, 2023 in the ongoing session of Parliament.
The Bill seeks 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.
The Bill proposes the establishment or designation of Central Drugs Laboratory, Central Medical Devices Testing Centre and State drugs laboratories and State medical devices testing centres.
A ministry official said that the regulation of medical devices will be carried out by an entirely different team based on a separate set of laws and hence will take care of all the concerns raised by the industry. He also added that the new law, along with policies to encourage start-ups and promote R&D will play a significant role in expanding the country’s innovation ecosystem.
