The drugs controller general of India (DCGI) has directed the clinical trial sponsors, clinical trial applicants and pharmaceutical manufacturers to provide compensation to the trial participants if any drug-related anomaly is discerned at a later stage and accepted to be drug-related injury or death.
The DCGI's action in this regard is pursuant to the Union health ministry's acceptance of the recommendations of the Prof Ranjit Roy Chaudhury committee, constituted by the ministry last year to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs.
“Pursuant to the above, with regard to the compensation in case of injury or death discerned at a later stage, it has been decided that compensation in case of injury or death discerned at a later stage should be paid to the trial participants/his or her nominee as the case may be, if any drug-related anomaly is discerned at a later stage and accepted to be drug-related,” the DCGI in his order dated July 3 said.
“In view of above, all sponsors/manufacturers, clinical trial applicants are hereby advised to provide compensation to the trial participants/ his or her nominee as the case may be, if any drug-related anomaly is discerned at a later stage and accepted to be drug-related injury or death,” the DCGI said.
Earlier in February last year, the health ministry had constituted an expert committee under the chairmanship of Prof Ranjit Roy Chaudhury to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs. After much deliberations, the committee submitted its recommendations in September, 2013, recommending sweeping changes in all these sectors.
After hearing the various stakeholders, namely the pharmaceutical industry, clinicians, civil society and research organisations, and after threadbare discussions among the members of the committee on the these issues, the committee recommended, “Compensation should be paid to the trial participants if any drug-related anomaly is discerned at a later stage and accepted to be drug-related by a competent authority, whether in India or abroad”.