India Moves to Pass Comprehensive Medical Device Regulations

A proposed bill from India’s Ministry of Health (MOH) would — for the first time ever — require the comprehensive regulation of all medical devices manufactured in or imported into India. On July 11, the Union Cabinet approved the Drugs and Cosmetics Bill, 2013, which will likely go before Parliament for a vote by the end of the summer.

Currently, there are no such regulations for all medical devices in India. Only 33 classes of medical devices are regulated, including catheters, cardiac stents, drug eluting stents, intraocular lenses and bone cement. Regulated medical devices are considered drugs under India’s Drug and Cosmetics Act (DCA), and must be certified by the DCGI before they can be sold on the market.

The Drugs and Cosmetics Amendment Bill calls for the creation of a new category — medical devices – that would be regulated in accordance with a risk-based classification system. The bill would also give MOH the power to create new rules regulating medical devices. These could include everything from clinical trial rules to penalties for violation.

The 2013 bill is the latest in a series of proposals to regulate medical devices in India. Since 2007, each attempt has failed to win passage in Parliament. This year, however, there seems to be growing support for the bill, as certain provisions would “strengthen the domestic manufacturing industry” and “make medical devices more accessible and affordable,” according to one MOH official.