DCGI to issue guidelines on compensation to clinical trial victims

With the increasing incidents of deaths and injuries related to clinical trials coming into the open periodically in the country, the Drugs Controller General of India (DCGI) will soon issue guidelines on providing proper compensation to the victims of the trials.

According to sources, the issue of providing proper compensation to the clinical trial victims came for discussion in the recently held meeting of the Drugs Technical Advisory Board (DTAB) which held its comprehensive meeting on October 10 under the chairmanship of Director General of Health Services (DGHS), who is the ex-officio chairman of the Board. After discussing the issue threadbare, the DTAB which is the highest decision-making body under the union health ministry on technical matters decided to come out with a guideline.

At present, there is no law in the country binding on the pharmaceutical companies to pay proper compensation to the clinical trial victims. In the absence of a law, there is no uniformity in providing compensation to the trial participants and different companies are using different yardsticks while providing compensation to the trial victims. The issue has caught the attention of the drug authorities in the country as there was public outcry over the issue for quite some time.

The DTAB's decision to come out with a guideline is significant as the laws governing the clinical trials in the country are vague on the issue of giving proper compensation to the trial participants. Though the Indian Council for Medical Research (ICMR) Ethical Guidelines for Biomedical Research on Human participants, 2006 have specified the need for provision of compensation of participants for research related injuries, in the absence of clear guidelines in this regard, the sponsors of the trials very often exploit the participants by simply providing some treatments.

Though the ICMR had some years back issued a draft guidelines for 'compensation to participants for research related injuries', it did not come out with the final document which would have set the standard for this highly unregulated area in the burgeoning clinical trial industry in the country.

To ensure better compensation to the clinical trial subjects in an organized manner, the ICMR had in November 2008 issued a draft guideline for compensation to participants for research related injury the in India. The new ICMR draft guideline proposed to bring uniformity in giving compensation to the participants. As per the draft document, the guidelines would apply to all clinical research, whether sponsored by the pharmaceutical or medical device industry, government or academia or individual investigators.