The Hindu Business Line : Medical devices market needs regulation: Board

THE Drug Technical Advisory Board (DTAB) seems to have driven the proverbial last nail into the coffin as far as the unregulated medical devices market in the country is concerned.

Following a meeting earlier this month, the DTAB has told the regulatory authority in India to notify medical devices under the Drugs and Cosmetics Act, 1940.

A senior representative with the regulatory Drug Controller-General of India's (DCGI) office told Business Line that rules will be drafted to define a medical device and the norms are likely to govern only sterile medical devices or those used in the body, such as stents or pace-makers. The rules are also likely to define labelling requirements, validity studies, etc.

The medical devices segment in India is both large and unregulated, said an industry official, unwilling to hazard a guess on the size of the market. The segment recently came under scrutiny from authorities when cases were reported in Maharashtra where illegal stents were allegedly used on patients.

Globally, medical devices are regulated and the approvals acceptable in the world market are from the FDA in the US or the European CE certification.

When the controversy broke in Maharashtra over the use of drug-coated stents, the local regulator allowed the use of products that had the US FDA or European CE certification to prevent patients from being inconvenienced by shortages that may have emerged.

Stents are tiny metal wires used to remove blockages, especially in the heart, and according to doctors, at least 70,000 stents - both plain and drug-eluting ones - have found their way into people's hearts.

Meanwhile, the Maharashtra regulator's contention that drug-eluting stents need a drug licence from the DCGI seems to have run into litigation, a senior official with the Maharashtra FDA told this correspondent. With the issue now in the legal arena, clarity will emerge only when it gets sorted out, he added.

Stents have always been at the heart of medical controversy. In 2004, Boston Scientific recalled its stents worldwide. However, no independent information was available in India on how many stents the company had sold in the domestic market. The only details available on the subject were from the company itself.

Similarly, Johnson & Johnson's drug-eluting stents have faced voluntary global recalls due to manufacturing defects. And stents form just a part of the domestic medical devices market.

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