It was made compulsory for the sponsor or his representative to prove before the Ethics Committee that the injury or death is not due to clinical trial within 30 days, failing which they shall be liable to provide the compensation within 60 days as decided by the Ethics Committee, the Union Health Ministry has said.

As part of the several measures to streamline the clinical trial sector, it was also made mandatory for the companies to settle the claims by the subjects within 90 days, Union Health Minister Ghulam Nabi Azad disclosed in Parliament recently.

12 New Drug Advisory Committees (NDAC) consisting of experts from the government medical colleges, institutes from all over the country have been constituted. Fresh applications of clinical trial proposals of new drug substances excluding Investigational New Drugs (INDs) Application are being evaluated by these Committees. All IND applications are evaluated by the IND committees, he said, while listing out the measures taken recently.

“Every approval/permission for conducting clinical trials now includes a condition that in case of study related injury or death, applicant will provide complete medical care as well as compensation for the injury or death and statement to this effect should be incorporated in the informed consent form. Further in case of such injury or death, the details of compensation provided should be intimated to the office of DCG (I). Guidelines for conducting Clinical Trial inspection of site and sponsor/ Clinical Research Organisations (CRO) have been notified,” he said.

Draft Rule and guidelines and requirement for registration of CRO have already been notified. Draft rules for incorporation/ amendments in Drugs and Cosmetics (D&C) Rules related to clinical trials have been notified to incorporate a new rule for provisions for payment of compensation in case of clinical trial related injury or death, and to incorporate New Appendix in schedule-Y mentioning the procedures and methods of providing compensation.

Rules were also drafted to amend the informed consent format to capture the details of address, qualification and occupation, and annual income of the subject and to amend patient information sheet to mention that the applicant will provide compensation in case of trial related injury or death.