In June 2009 the Drug Consultative Committee (DCC) and the Drug Technical Advisory Board (DTAB) approved new formal regulations for India’s medical device sector. The new regulations have been sent to the Ministry of Health for final notification, which is expected soon.
As of yet, India’s medical device sector has been largely unregulated. There is currently no specific definition for medical devices, and only certain devices are regulated as drugs by the Drug Controller General of India (DCGI). The new regulations will provide a specific definition for medial devices and create a formal category for medical devices separate from drugs. The DCGI will expand its medical devices wing to enforce stricter oversight on the import and manufacture of medical devices. In March 2009, the DCGI proposed 19 additions to the list of medical devices requiring registration. The number of additions is expected to expand to 49 new categories of medical devices with the new regulations.
The new regulations were devised by a task force consisting of trade bodies such as the Indian Chamber of Commerce and Industry and the Confederation of Indian Industry. The task force was advised by the World Health Organization, the United States Food and Drug Administration, industry experts, and public opinion.