The Supreme Court of India last week issued an order staying all the 162 approvals granted by Drugs Controller General of India for conducting clinical trials in India. The order was passed by a bench headed by Justice R M Lodha on a petition filed by health activist group Swasthya Adhikar Manch alleging serious irregularities in conducting trials in the country. The order has given a major blow to the pharmaceutical companies and contract research organisations (CROs) which have been waiting for long to get the approvals. For several months approvals for clinical trials were on hold on account of growing criticism on the way trials are being conducted in India. Such a stand of the DCGI made pharma companies and CROs to represent to Health Ministry to restart granting permissions for trials again. And between July and August 2013, the DCGI had received as many as 1122 applications for clinical trials and of which the New Drug Committee approved 285 but the DCGI office cleared only 162. It seems that the Apex Court is still under the impression that the country does not have the right mechanism to monitor the clinical trials and thereby save lives of thousands of subjects who undergo trials in the country. This is clear from the harsh observations the Court made when it said that uncontrolled clinical trial of drugs by multinational companies were creating havoc in the country and the Centre failed to stop these rackets which caused deaths. The SC, thus, asked the Centre to first create a foolproof mechanism in the country and has given 10 weeks time to come out with a proper plan for implementing the same.

Concerns over allegations of unethical clinical trials in the country gained momentum especially after reports of deaths of some innocent girls during the course of a drug study in rural Gujarat and Andhra Pradesh. As per reports, the victims were participants in a trial for cervical cancer vaccine. In the trials that took place in 2010, the vaccine was given to 14,091 girls in Khammam district of Andhra Pradesh and 10,686 girls in Vadodra, Gujarat. These girls were in the age group of 10-14 and of which 7 girls died during the trials. Last week, the Supreme Court has sought a report from the Centre on the reported irregularities during the conduct of these studies by international organisation PATH. An impression has been created that many of the clinical trials that are carried out in India do not address safety of the subjects adequately and meet international standards. From the government side, the health ministry already notified the rules and procedures for fixing compensation to the victims of trials giving legal backing to the existing guidelines. The rules thus notified by the government under Drugs & Cosmetics Rules had put the DCGI as the final authority in the matters relating to the compensation in the cases of deaths and injuries during trials. It also made registration of the ethics committee at the trial sites mandatory. These safeguards could probably ensure fair conduct of clinical trials in the country. What steps the office of DCGI has taken to enforce these new measures is the issue under question.