The observations made by the Division Bench of Bombay High Court early last week over the use of drug eluting stents (DES) on patients in Mumbai’s JJ Hospital have exposed the existing confusion prevailing in the working of drug administration in the country. The judges were shocked to learn during the course of the hearing of a case filed by Shruti Medi Science Pvt Ltd that a life saving product like DES were being sold and used in India without approval of the Central government. Shruti, one of the suppliers of DES in India, had challenged the Maharashtra FDA decision last June to ban the use of DES in the state as the product is not approved by DCGI. Maharashtra FDA banned the DES in the state as it considered the product as a new drug as the DES contains an unapproved drug. Any new drug needs to be approved by the Drug Controller General of India 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, the DCGI has decided to bring the product under the regulatory provisions.

DES combines a drug with medical device to provide more effective care for many patients with heart disease. These products have been in use in the US since last few years. FDA approved the stent based on a review of laboratory and animal tests and two clinical studies of safety and effectiveness as well as a review of manufacturing procedures of this combination product. The DES slowly releases the drug and has shown in clinical studies in the US to significantly reduce the rate of re-blockage that occurs with ordinary stents. The concern expressed by the judges about the safety of DES is indeed very serious considering the fact that product is implanted into the bodies of heart patients. Thousands of heart patients are already carrying the product in their bodies without having any idea about its potential risk factors as no clinical trials have been conducted in the country. In the absence of any Central directive on its use and with no action initiated against its use by other state drug authorities, hospitals across the country must be still using DES freely on patients. How a situation like this should be allowed to exist when competent authorities are functioning in this country. The office of DCGI should have been aware of free marketing and use of such a critical product like DES in the country and brought it under the D&C Act with immediate effect. And that is what surprised the judges and motivated them to summon DCGI to the Court for the next hearing of the case fixed on September 19.