In the month of March, 2013, the Drugs Controller General (India) constituted three Independent Expert Committees in pursuance of sub-clause (6) of appendix XII of the Schedule Y to the Drug & Cosmetics Rules 1945 to examine the Serious Adverse Events of deaths occurring during clinical trial and to recommend the cause of death, and to determine the quantum of compensation, if any, to be paid by the Sponsor or his representative, whosoever had obtained permission from the DCG (I) . The Committee after deliberation prepared formula to be followed for the determination of Quantum of Compensation in case of Clinical.
The expert committee recommended that the risk factor involved in the conduct of clinical trial shall be divided in a scale of 0.50, 1.0, 2.0, 3.0 and 4.0. Further, depending on 2 factors i. e the age of the deceased and the risk factor involved in the conduct of the clinical trial, the calculation for the compensation amount will vary from a minimum of Rs. 4 lakhs to a maximum of Rs. 73.60 lakhs. However, in case of patients whose expected mortality is 90 per cent or more within 30 days, a fixed amount of Rs.2 lakh should be given.