The Hindu Business Line : Drug-coated stents need licence: Maharashtra FDA

THE use of illegal drug-coated stents on heart patients has forced the Maharashtra Food and Drugs Administration (FDA) to instruct manufacturers and importers to get a drug licence from the Drug Controller General of India before resuming sales of this medical device.

The FDA's new chief, Mr M. Ramesh Kumar, told Business Line: "During an investigation, we found importers and distributors had no approvals. We have asked them and the manufacturers to get licence as a new drug (from the DCGI)."

The country's medical devices market is largely unregulated. The FDA's initiative comes in the wake of recent reports that a leading Mumbai-based hospital had used illegal stents on its patients.

Stents are tiny metal wires used to remove blockages in blood vessels, especially of the heart. And despite its cost of Rs 1 lakh, doctors across the country are increasingly using the procedure. According to Dr B. K. Goyal, a reputed cardiologist with Bombay Hospital, about 70,000 stents (both plain and drug-coated) have been used in the country.

However, to avoid inconveniencing patients, Mr Kumar said that manufacturers with global certification from the US FDA or those with European CE certification would be allowed to sell the device.

In the local market, multinational companies Johnson & Johnson and Boston Scientific have global certifications, a regulatory official said.

All importers, distributors and manufacturers wouldhave to acquire a drug licence for their drug-eluting stents in two months, Mr Kumar added. Products are imported from Singapore, China and Korea with no approvals. The drug used on the stent has to be of a particular dosage, released over a certain time, he said. "If the quality of the product is not ensured, then the drug could be in the body longer than it should and that is counter-productive." A DCGI official said that efforts were on to expand the ambit of the regulatory agency's role and medical devices were being looked at in a limited way. On the stent-related issue, he said the DCGI would examine it following an intimation from the Maharashtra FDA.

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Drug-coated stents need licence: Maharashtra FDA