Last month, National Human Rights Commission asked Indian Council of Medical Research and the office of Drugs Controller General of India to provide a detailed report on the status of clinical trials being conducted in India. NHRC’s demand is in the wake of growing number of deaths taking place while conducting clinical trials in the country during the last two to three years. As per the health ministry’s records, 671 persons had died during clinical trials last year and a majority of them were sick volunteers. And the ministry admits that most of the dead volunteers were not given any compensation by the CROs or the pharmaceutical companies. It is unfortunate that the pharmaceutical companies and their agents getting away with this kind of gross unethical practices in the name clinical trials. Ever since the clinical trials started on a big scale in the country, reports were appearing in the media about the unethical practices indulged in by CROs in clinical research. The health ministry is fully aware of this fact but has not been taking any serious steps to bring in effective regulation in this sector. This is despite the demands for enforcing proper regulations to monitor and control clinical trials from various sections of the society. A public interest litigation is expected to come up in the Allahabad High Court calling for a ban on all clinical trials until specific laws to govern trials are in place. Civil society groups have alleged that clinical trial monitoring is not mandated under the Drugs & Cosmetics Act 1940 and yet the government is regulating the trials as per the provisions of the Act.
The health ministry has been working for last ten years to put in place a set of comprehensive rules to regulate clinical research with flow of large number of contract research jobs into the country. Country cannot afford to have such laxity in enforcing appropriate laws to this vital area of medical research. Multinationals and CROs are aware of this deficiency in law and they are fully exploiting the situation at the cost of human lives. What the country has is a set of guidelines after amendment of the Schedule Y of Drugs & Cosmetics Act. There are no indications when these rules will be finalised and implemented. It is in the background of this uncertainty, health ministry made it mandatory for the CROs to register themselves in July 2009 to have some accountability. Even this registration process is not progressing as expected. Ethics Committees at most of the trial sites are also not active with no proper monitoring of trials. Considering this dismal state of affairs in regulating clinical trial sector, NHRC's action is a welcome step to generate some public interest and action.