On August 30, 2013, India’s Ministry of Health proposed legislation that would — for the first time in the country’s history — require the comprehensive regulation of all medical devices manufactured in or sold in India. The Drugs and Cosmetics (Amendment) Bill 2013 calls for the establishment of a separate category for medical devices and the creation of a Medical Devices Technical Advisory Board to advise regulators.
In addition, the bill calls for a sweeping overhaul of the current regulatory system. It introduces a 19 member Central Drug Authority (CDA), which would replace India’s Central Drugs Standard Control Organization (CDSCO). The CDA would appoint medical device officers and oversee the licensing of all drugs, devices and cosmetics manufactured in or sold in India. The CDA would also take over the regulation of 17 classes of “critical drugs,” including gene therapy products, blood products and vaccines. Currently, most “critical drugs” are licensed by state authorities.
This is the third time that such a bill has been introduced before the Indian Parliament. Other versions failed to pass in 2005 and 2007 but this time it is likely to pass soon.
If passed, the new bill will have a significant effect on India’s $3.5 billion medical device industry. Only 33 classes of medical devices are currently regulated, including cardiac stents, drug eluting stents, intraocular lenses, catheters and bone cement. These medical devices are classified and regulated as “drugs” under India’s Drug and Cosmetics Act. The new bill would move these products into the “medical devices” category, and would bring many other unregulated medical devices under the licensing authority of the CDA.