Compensation for Victims of Clinical Trials: A Discussion on How Current Indian Rules and Guidelines are Hurting India.

According to the amended Drugs and Cosmetics Rules of the Government of India, participants in clinical trial are entitled to medical treatment and financial compensation in the event of permanent injury or death, but the quantum of compensation is to be decided by same Ethics Committee that sanctioned the trial in the first place. If there is a dispute regarding the amount of compensation the injured party may appeal again to the Ethics Committee for a review and reconsideration. The decision of the Ethics Committee after the review is final [1].