Drug-eluting stents (DES) are designed for the controlled release of drugs into surrounding tissue. These types of stents are particularly useful in preventing the re-narrowing of arterial walls, or restonosis, after cardiovascular procedures. This technology was recently introduced into the Indian medical market in 2002. However, since the introduction of drug-eluting stents into India, the government has yet to classify the medical technology as a drug or as a medical device. Thus, there are currently no laws regulating the quality, safety, and marketing of drug-eluting stents in India.
Currently, all drugs in India are regulated under the Drugs and Cosmetics Act of 1940. India presently does not have extensive laws regulating medical devices in the country. Since drug-eluting stents have yet to be brought under the classification of drugs, these products are not regulated in India. However, experts in India are concerned about the lack of regulations and are advocating measures to protect consumers of these products.
Dr. Ashok Seth of the Escorts Heart Institute in New Delhi warns “With no regulatory body for DES, patients will end up being made guinea pigs.” Although most DES products imported into India have undergone extensive testing and clinical trials, experts believe that the government must step in to regulate these products to prevent the threat of inferior quality stents entering the Indian marketplace.