Medical devices are critical implants increasingly used in patients' bodies for treating various disease conditions world over including in India. And the use of drug eluting stents (DES) is most widespread as they are considered necessary for the survival of thousands of cardiac patients. DES combines a drug with a medical device to provide more effective care for patients with heart disease. The US FDA approved the use of DES based on a review of laboratory and animal tests and two clinical studies of safety and effectiveness as well as a review of its manufacturing procedures. DES slowly releases the drug and has shown in clinical studies in the US to significantly reduce the rate of re-blockage which occurs in as many as 15 to 30 per cent of patients who receive a bare metal stent. The stents have been in use in many other developed countries too for almost 10 years and they are found to be helpful in eliminating multiple surgeries requiring to reopen the artery due to scarring. There should be no two opinion that the use of critical medical products such as DES and others in India should have passed through strict regulatory procedures before being sold or used in patients. Surprisingly, the Maharashtra FDA found in June 2005 that DES had no approval from the DCGI office and it rightly imposed a total ban of the product in the state. The state FDA banned DES as it considered the product a new drug as the 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 device as per the Drugs & Cosmetics Act. Now after the DES approval issue was raised by the Maharashtra FDA and subsequently with the intervention of Bombay High Court, the DCGI decided to bring the product under proper regulatory provisions. The first regulatory step took by the DCGI was to issue a notification in October 2005 identifying 10 medical devices as drugs. But the larger issue here is to lay down specific rules relating to product standards, safety, clinical trials, manufacturing practices. On this front, the Central drug authority has failed to come out with even some guidelines as yet. What has been done so far is to set up a sub-committee consisting of officials from CDSCO and from various state drug control offices by the Drugs Consultative Committee in December last to formulate rules for licensing of 10 medical devices notified as drugs. Now, this sub-committee will have to set standards for manufacturing, testing and qualification of technical staffs both in production and testing process for each notified device. What is shocking here is the casual attitude of the Central government in addressing such a serious health issue. First of all, the Central authorities should not have taken such a long time to formulate rules for marketing and use of critical medical devices after inadequacy of regulations brought to its notice. Secondly, having recognized the ineffectiveness of rules covering medical devices, the sub-committee should have been entrusted to frame rules for the entire segment of medical devices.