New Delhi: Pharmaceutical firms conducting clinical trial of drugs in India will no longer be able to get away with meagre and arbitrary payment of compensation in case of injury or death of subjects participating in such trials.
For the first time in the medical history in the country, the Government has notified rules for grant of compensation in case of Serious Adverse Events (SAEs) like death and injuries on account of participation in clinical trial of drugs including biological and medical devices.
There were no compensation provisions so far under the Drugs and Cosmetics Rules which govern approval of clinical trials by the Government.
Compensation would now be awarded within three months of the reporting of injury or death. In the past five years, 2,242 people have died during drug trials in India, with an average compensation being awarded per death being a meagre Rs 2.2 lakh as per Health Ministry data.
"With the notification of procedures of compensation, the Government has ensured the safety and rights of subjects participating in clinical trials. Henceforth all trials will be monitored at all the stages," a senior Ministry officer said.
Drug Controller General of India, the apex drug regulator, will be the final authority for deciding the causes of injuries or death in clinical trials and also approving the final compensation amount in each case.
Categories for grant of compensation have also been fixed depending on death, severe injury and minor injury and minimum compensation amount would soon be notified.
So far, Ethics Committees set up by the sponsors of clinical trials, have been deciding the amount of compensation to be awarded in case of drug trial related injury or death.
The amount would often be very low, a fact also pointed out by the parliamentary standing committee on health in its report on drug trials.
According to the new notification, Ethics Committee of the medical institute conducting the trial, the sponsor of trial and its principal investigator will have to report the injury or death within 24 hours and submit their separate reports to the independent expert committee set up by the DCGI to review the case.
The DCGI would recommend the final payment based on the independent probe panel`s report, thus ruling out bias and unfairness.