India govt seeks to improve medical device regulations, divided over how

Seeking to improve the safety, effectiveness, and oversight of medical devices, India’s government is again considering a series of laws that would establish a regulatory framework for medical technologies. But government health officials remain divided over which course to take to tighten regulation of the growing industry.

One proposal floated late last year by a government think tank is to establish a regulatory agency for medical devices that would be separate from that overseeing pharmaceuticals. Under that proposal, a separate regulatory organization, the Medical Devices Administration (MDA), would be established to regulate medical devices, akin to the Central Drugs Standards and Control Organization (CDSCO) which currently regulates both pharmaceuticals and medical devices. As envisioned, the move would improve medical device quality and aid in the development of a domestic medical device industry in a nation that has been dependent on imported foreign medical device manufacturers.

But some government officials — and some medical industry leaders —argue that the regulation of medical devices should remain under the existing Drugs and Cosmetics Act and CDSCO. They argue that the existing regulatory framework is sufficient to regulate medical devices.