While the office of the Drug Controller General of India is still grappling over the issue of regulatory control on the use of drug eluting stents in the country, some interesting facts over the safety of these life saving products have come to light at the recently concluded Interventional Cardiology Summit 2007 in Goa last month. A group of medical experts at the Summit was of the view that DESs are more prone to late stent thrombosis, which may lead to sudden death of patients. Another group of cardiologists, however, has been strongly recommending the use of DES instead of bare metal stents. The argument is that late stent thrombosis, which can develop anytime after six months after implantation of DES, may not allow enough time to save the patient. Whereas, BMS does not have such a high risk after six months although it is prone to restenosis. Even in the case of restenosis, BMS will allow some time to save the patient unlike in the case of DES. It is not surprising, therefore, that these conflicting views on the use of stents are causing a lot of anxiety amongst the medical community and patients over the safety of these critical products. Implantation of these products in patients is also an expensive procedure costing about Rs 1.5 lakh. Both these products have been in use in the country without the marketing approval from the DCGI for several years. No clinical trials have been conducted in the case of DES although it contains a drug. The fact that DES had no approval from DCGI was found by Maharashtra FDA in June 2005, and it imposed a total ban of the product in the state. The state FDA action comes as it considered the product a new drug as DES contains an unapproved drug. Any new drug needs to be approved by the DCGI before marketing it in the country. And DCGI has never approved DES for marketing in India as it treated DES only as a medical device as per the Drugs & Cosmetics Act. Now, Abbott Laboratories has developed a first biodegradable stent. The product with less chances of thrombosis and restenosis, is undergoing clinical studies for the safety and efficacy. The biodegradable stent, a device intended to tackle blockage in arteries without the help of metals, is expected to degrade within a month after the implant. The product, if found successful, could be able to avoid late stent thrombosis and restenosis in the patient and it could be the most preferable system globally after the development of DES, some cardiologists feel. Another product, a BMS with a balloon for drug delivery to counter the drawbacks of both ordinary BMS and DES by Eurocor GmbH is also under development. The new product, with cobalt chromium with a balloon acting as a drug delivery device has already completed the clinical trials in Europe. It is possible that many more such products may enter the market and the inventor companies would try to push and promote them through the surgeons in India considering the huge size of the market. It is important that the Union health ministry and the office of DCGI should be extremely vigilant over launches of such products in the country in the interest of large number of patients. As it is, DCGI is yet to notify rules for licensing of 10 medical devices classified as drugs after several months of appointment of a subcommittee for the purpose.