"We have issued a directive on June 6 asking all manufacturers and importers of drug eluting stents to get a DGCI license in the next two months," M Ramesh Kumar, FDA commissioner said in Mumbai on Monday.
The manufacturers having USFDA or European CE certification would be allowed to sell these stents, he added. The FDA's initiative comes in the wake of recent reports that a leading hospital had used illegal stents on its patients.
Kumar said there were around 20 manufacturers and importers of drug eluting stents in the country. Johnson & Johnson and Boston Scientific are the major stent making companies, which have regulatory approvals.
However, a large number of stents imported from countries like China and Korea do not have regulatory approvals.
Stent is an expandable mesh tube, which is used to remove blockages in blood vessels, especially of the heart. Drug eluting stents contain drugs that potentially reduce the chance that arteries will become clogged again.
Meanwhile, reacting to the letter written by Johnson & Johnson showing its willingness to display a safety warning and declare details of all the ingredients in its baby oil, Kumar said the FDA was yet to take a decision.
"They have written us a letter agreeing to display a safety warning and mention all the ingredients on the label. We are yet to respond to their letter and hope to take a decision in the next few days and then get back to them," Kumar said.
The Maharashtra FDA had earlier asked J&J to replace liquid paraffin as an ingredient in its baby oil products or pull out descriptions like the word 'baby' from the packs.
