In a move that will go a long way in ensuring the safety of subjects who participate in clinical trials in India, the government has notified procedures whereby compensation will be awarded in case of death or injury suffered by persons participating in the trials.

Hitherto, there was no rule under the law to provide for compensation in case of serious adverse events or injuries to subjects in clinical trials. The Drug Controller General of India (DCGI), the highest drug regulator, approves the conduct of clinical trials under the Drugs and Cosmetics Rules. But these rules have no procedures or even a mention of compensation to be given in case a participant in a trial suffers injury, disability or death.