The medical devices sector, an unregulated segment due to factors ranging from lack of clarity in policies to absence of quality checks, may finally get a regulatory structure as a separate category instead of being bracketed with new drugs.

The office of the Drugs Controller General of India (DCGI) has already taken the feedback from the industry on the matter and drafted guidelines to treat medical devices as a different category to be monitored and regulated by the DCGI.

The WHO and the US FDA are helping the Indian drug control administration to frame the guidelines on par with those in the developed countries. The US FDA, as part of its strategic alliance with the CDSCO, has already identified medical devices as focussed sector to improve, along with clinical trials and other areas. A workshop to impart the training to the Indian officials on the required guidelines and monitoring medical devices will be held by US FDA officials sometime by the end of October. And the DCGI office will publish the guidelines for feedback from the public by December and finally the new guidelines are likely to be notified by March, sources said.

A number of meetings have been held by the DCGI with the industry associations after a core group was set up to sort out the issues and draft the guidelines. Based on the inputs from these organisations including concerned forums of FICCI and CII, the new guidelines have been drafted, sources said.

The Indian authorities are also planning to take inputs from their counterparts in different countries, including developed and developing nations, on the set of guidelines as many of these countries had already put in place fool-proof system to monitor the sector and improve the quality of devices.

As part of ensuring quality, the DCGI had recently slapped a public notice asking the unlawful manufacturers to obtain licences from the State licensing authorities and get them approved by the central authority. Cardiac stents, drug eluting stents, catheters, intra ocular lenses, IV cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants, and internal prosthetic replacements had been brought under the purview of Drugs and Cosmetics Act, making it mandatory to get licence for manufacture for sale and distribution in 2005.