India FDA Asks Stent Makers to Get Drug Licenses

June 13, 2005

The Maharashtra FDA commissioner has asked all drug-eluting stent manufacturers and importers to get valid drug licenses from the Drugs Controller General of India within the next two months.

Recent reports of hospitals using illegal stents on its patients led to the new initiative. Maharashtra FDA Commissioner M. Ramesh Kumar said there were nearly 20 manufacturers and importers of drug-eluting stents in the country. While companies such as Johnson & Johnson and Boston Scientific have regulatory approvals, a large number of stents imported from countries such as China and Korea do not.

To avoid inconveniencing patients, manufacturers with U.S. FDA or European CE certification would be allowed to sell the stents in the country.