CDSCO calls for suggestions on draft guidelines for compensating clinical trial victims

Usha Sharma – Mumbai

The Central Drugs Standard Control Organisation (CDSCO) has called for recommendations and suggestions on its draft guidelines, issued on August 3, 2012, for determining quantum of financial compensation to be paid in case of clinical trial related injury or death. It has welcomed the views of one and all, including the common public. However, the recommendations need to be sent within 30 days from the time the guidelines were issued i.e. on or before September 2, 2012. All the suggestions and recommendations will be reviewed by an expert committee set up by CDSCO before the Ministry of Health settles on the final provisions of the guidelines.

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. 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.

According to a ministry source, “In November 2011, the Indian Council of Medical Research (ICMR) and CDSCO under Directorate General of Health Services and Ministry of Health and Family Welfare, drafted the noticification for compensation of research-related injury, which evoked strong response from the clinical research community. The quantum compensation draft guidelines (Aug 3, 2012) are linked to the (Nov 2011) detailed notification for compensation trial-related injury or death. By the time the amended rules come into force, the guidelines should be in place for the purpose of implementation of the rules and soon it will become a Rule.”

As per draft guidelines, 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, 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 guidelines recommend that 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 finalisation.

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. 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 were formulated in response to concerns raised during Question Hour in Parliament and other forums regarding payment of compensation in the cases of injury or death in clinical trial. The Drug Technical Advisory Board (DTAB), the highest technical body under D&C, Act, has endorsed adoption of this GCP guideline for streamlining compensation related issues arising during clinical studies in India.

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