The Drug Controller General of India said it would write to the US Food and Drug Administration seeking information on the clinical trials of drug-eluting stent CoStar, manufactured by Conor Medsystems Llc. The CoStar stent, which failed to meet the efficacy standards of the US drug regulatory agency and was pulled from the market by its new owner Johnson & Johnson, has been sold in India for three years.
“Considering the doubtful efficacy of the product as per the US study, we have already urged the Indian distributor of CoStar to stop disposal of remaining inventory into the market,” said drug controller general M. Venkateswarlu. “Efficacy profile of a drug is different from safety aspects. When taken, the drug may not cure the ailment, but it may not harm the patient either.”
The controller’s move is a step towards issuing an official notification to stop the use of the stent here. Since marketing of the medical device is approved in India, it is a routine procedure followed by the regulator in the run-up to a ban.
Officials in the drug control office said that since the US trials on CoStar has not reported any serious impacts on its safety profile, there is no reason for panic about the safety of the patients, who have been implanted with the stent.
The drug regulatory office has already issued Form 15 of the Drugs and Cosmetics Act, suspending stock disposal till further order, to Interventional Technologies Ltd, the distributor of the stent in India.
A spokesman for Interventional Technology said the company has already initiated withdrawal of unsold stock from its retail distributors across India. “Soon after we received a letter from our principal on Thursday, we asked our retailers to stop sales on our own,” the company spokesman added.
CoStar stents were approved for marketing in India in 2003.
“We have sold about 3,200 stents so far,” said a spokesman for Interventional Technology. A senior official from the drug control department in Mumbai said, “About 5,000 CoStar stents have been imported so far and there is an inventory of less than 1,000 with the main distributor. The rest could be available in the market,” the official said, requesting anonymity.
But, “the number of CoStar implantations in the country could be more also as imports were taking place thorugh other channels. The drug-eluting stent, which was a revolutionary treatment for recurring cases of artery blocks, was imported using special provisions for hospitals even before it was approved for marketing in India”, says a leading healthcare consultant, who didn’t want to be named.
The CoStar stent is sold at Rs1 lakh in city hospitals. A stent implantation in a speciality hospital here typically costs, including the cost of the stent, implantation procedure and pre- and post-surgery expenses, a patient around Rs2-2.5 lakh.