Health ministry planning makeover of laws governing domestic medical devices industry

NEW DELHI: The health ministry is planning a makeover of the laws governing the domestic pharmaceutical and medical devices industry. The Drugs and Cosmetics (D&C) Act and Rules will likely see revision in norms related to the examination of new drugs, systems and modes of drug delivery, a source close to the development said.

The ministry is in the process of preparing a draft set of rules for medical devices under the existing Act as well as a completely new law to replace the 1940 Act, said a senior health ministry official, who did not wish to be identified.

A new law is expected to be better suited than amendments to accommodate innovations and developments in pharma and healthcare, including those in regenerative therapy, the official told ET. It is also expected to improve ease of doing business for the industries without compromising on safety, efficacy and quality of treatment here, the official added.

“All (new therapies and drugs) cannot be catered in a law or rule which remains stagnant," said the official. "We wanted to amend the D&C Act last year, but it was decided that it would not be very fruitful."

Through the Rules, the health ministry intends to expand the coverage of medical devices regulated in the country, the official said, adding that the first draft is ready and will soon be implemented to test their efficacy before preparing the law.

At the same time, the proposed Rules would operate under the ambit of the current D&C Act, which still considers medical devices the same as drugs, said medical device association AdvaMed. This means that more devices would be notified and inappropriately addressed as drugs, a spokesperson told ET.

The ministry’s Central Drugs Standard Control Organisation (CDSCO) recently notified that it was revisiting the existing Act and Rules, inviting feedback by June 21 on changes required to improve the country’s existing legislation to meet the current regulatory requirements.

Some pharmaceutical associations, while stating that the ministry may only amend the existing Act instead of creating a new one, said that the need for changes to Act was felt as far back as 2008.

Associations like the Indian Pharmaceutical Alliance (IPA) and the Indian Drug Manufacturers Association (IDMA) speculate that the government’s latest exercise could be a means to update the Bill in time for the Parliament’s monsoon session.

The ministry last attempted to amend the Act through a Bill introduced in the Rajya Sabha in 2013. The Bill, reintroduced in 2014 and 2015, is still pending.