India requiring compensation for clinical trial injuries/deaths

India's Ministry of Health and Family Welfare issued new regulations late last month that require clinical trial sponsors to provide compensation to patients who suffer injury or death during or as a result of the trial, including as a result of the "failure of investigational product to provide intended therapeutic effect." Under the regulations, sponsors must provide free medical care "as long as required" to patients who suffer an injury during the trial and provide additional financial compensation "over and above any expenses" if the injury is trial-related. In the case of a trial-related death, the patient's "nominee(s)" are eligible for financial compensation. According to the regulations, injuries or deaths due to adverse effects or the use of placebo are considered trial-related.

Under the regulations, trial sponsors must report any injury or death within 24 hours and provide an analysis on the cause of the death within 10 days. An independent "expert committee" will recommend the financial compensation based on a review of the injury or death, and the local licensing authority or Drugs Controller General of India (DCGI) will then determine final compensation amounts. If a trial sponsor does not provide medical care or financial compensation, the regulations state that local licensing authorities can halt a trial and prohibit a sponsor from conducting additional trials in India. ...