The Central Drugs Standard Control Organisation (CDSCO) has issued draft guidelines for determining the quantum of financial compensation to be paid in case of clinical trial related injury or death, as part of streamlining the entire sector.

“Presently there is no specific provision under Drugs and Cosmetics Rules for payment of compensation in case of clinical trial related injury or death of the subject. However, the Good Clinical Practice (GCP) Guidelines for Clinical Trials of India under para 2.4.7 provides that the research subject who suffers physical injury as a result of their participation in clinical trials are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability subject to confirmation from Ethics Committee. In case of death, their dependents are entitled to  material compensation. Guidelines further provide that it is the obligation of the sponsor to pay the compensation.  The concerns were also raised in Parliament and other forums  regarding payment of compensation in the cases of injury or death in clinical trial,’’ said the guidelines issued for inviting feedbacks from the stakeholders.

“There needs to be a simple and expeditious procedure for payment of  compensation and criteria for determining the amount of financial / material compensation to be paid in the cases of study related injury to the subject or in case of death to his/her nominee(s). To incorporate specific provisions for procedures to be followed for payment of compensation in case of trial related injury or death,  draft rules have already been published which is under consideration for finalization. The proposed draft rule 122 DAB in clause (1) and (2) provides that in case of trial related injury or death financial compensation will be provided in accordance with the recommendations of the Ethics Committee as per the guidelines  prescribed for the purpose. By the time the amended rules come into force, the guidelines should be in place for the purpose of  implementation of the rules,’’ it said.

This guidance document describes the methods to be followed by the  Ethics Committees  for calculating the quantum of  financial  compensation to be paid in case of clinical trial  related  injury or death. These guidelines apply to all such cases of clinical trial including BA/BE studies related injuries or death occurring during clinical trial of drugs including biological and medical devices covered under Drugs & Cosmetics Act.

The guidelines also have made specific methods to calculate the quantum of financial compensation, based on parameters like the age  and income of the deceased, seriousness of the injury, and the percentage of the permanent disability.