India Issues Final Rule on Compensating Clinical Trial Deaths

India’s Central Drugs Standard Control Organization (CDSCO) has released amended rules specifying the formula and the process that will be used for determining the amount of compensation to be paid by clinical trial sponsors for the death of a clinical trial research subject. 

Under the amended rules, which took effect on 30 May 2014, an Independent Expert Committee will examine the report of the death and make a recommendation within 30 days to the CDSCO as to the amount of compensation to be paid.  Criteria to be considered by the Committee include the age of the subject, and the risk factor depending on the severity of the disease, presence of co-morbidity and duration of the disease in the subject at the time of enrollment in the trial.

After the Expert Committee makes its recommendation, the CDSCO will make a final decision on the issue, and will inform the sponsor with three months as to the amount of compensation that must be paid.  The sponsor has 30 days from receipt of the CDSCO’s order to pay the amount.

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