Cardiac Stents Without Approval

Recent media reports about the use of unapproved cardiac stents on heart patients in Mumbai's JJ Hospital have brought to light the pathetic state of regulatory control on medical devices in the country. Maharashtra FDA which detected the case, has found that these imported drug eluting stents were being used by the Hospitals on patients without any regulatory approvals. FDA officials have found that 10 companies in Mumbai were importing these stents from various countries and selling to different hospitals in the city. The drug-eluting stent was developed to address the problem of in-stent blockage which occurs in as many as 15 to 30 percent of patients who receive a bare metal stent. In case of drug eluting stents, the drug imbedded in the stent is released into the lining of the artery, preventing the growth of scar tissue around the stent, the primary cause of re-blockage. The stents have been in use in developed countries for almost 10 years but drug eluting stents claim to eliminate the chances of multiple surgeries to reopen the artery due to scarring.

In India these products are not approved by the Drug Controller General of India for marketing in the country. As the stent contains a drug, the companies should have applied and obtained a marketing approval from the office of DCGI. And these importing companies neither have marketing approvals from DCGI nor trade licenses from the state FDA.

Ramesh Kumar, Commissioner of Maharashtra FDA has, thus, rightly asked the companies to obtain a drug license if they have to continue selling them to hospitals. Now, it is not only in Maharashtra theses stents are being sold but in other states too. And no one other states has woken up to ask the stent importers at least to obtain drug license. What is surprising is that DCGI has neither taken a clear stand on the matter of marketing approval nor about obtaining a trade license for such a critical product. Medical devices are defined as drug under section 3 of the Drugs & Cosmetics Act but no rule exists for their certification, quality assurance and post marketing surveillance. The fact that no statutory system exists for regulating the manufacture, import and monitoring of medical devices does not justify country's Central drug authority remaining a mute spectator. There is an urgent need for inclusion of empowering provisions in the D&C Act to regulate the use of medical devices in the country in public interest. A proposal to set up Indian Medical Devices Regulatory Authority as an independent body was made by the society for Biomedical Technology in 2003. The proposal was however rejected by the Mashelkar Committee and it suggested to make use of the existing nationwide drug control administration for the purpose. The committee also called for a separate Medical Devices Division within the central Drug Standards Control Organisation to oversee this operation. But nothing happened thereafter.

(Ref : Chronicle Pharmabiz dated June 16, 2005)