The drugs controller general of India (DCGI) has constituted an Independent Expert Committee (General) for examination of reports of serious adverse events (SAEs) of deaths occurred during clinical trials in the country. The 8-member committee, headed by Dr Arun Agarwal, Professor of ENT, Maulana Azad Medical College, New Delhi, will be in force till March 31, 2016.
Dr Shobhna Bhatia, SGS Medical College and KEM Hospital, Mumbai; Dr Sandeep Garg, Maulana Azad Medical College, New Delhi; Dr Kamlakar Tripathi, Institute of Medical Science, BHU Varanasi; Dr Santanu Tripathi, School of Tropical Medicine, Kolkata; Dr Madhuri Behari, AIIMS New Delhi; Dr Sangita Yadav, Maulana Azad Medical College, New Delhi; and Dr Sheffali Gulati, AIIMS New Delhi are the other members of the committee which will function under the provisions as specified in Appendix XII of the Schedule Y of the Drugs & Cosmetics Rules.
The chairman of the committee will receive reports of serious adverse events of death from investigators, sponsors or his representatives whosoever had obtained permission from the DCGI for conducting the clinical trial and the ethics committee. The committee will examine the reports of serious adverse events of death, to determine the cause of death and if the cause is due to reasons which are considered as clinical trial related death , then it will give its recommendation to the DCGI.
The committee will examine whether the death has been happened due to adverse effect of investigational products; due to violation of the approved protocol, scientific misconduct or negligence by the sponsor or his representative or the investigator; whether it is due to the failure of investigational product to provide intended therapeutic effect; due to use of placebo in a placebo-controlled trial; due to adverse effects due to concomitant medication excluding standard care, necessitated as part of approved protocol; for injury to a child in-utero because of the participation of parent in clinical trial; and due to any clinical trial procedures involved in the study.
In case of clinical trial related death, the committee will also give recommendation to the DCGI the quantum of compensation to be paid by the sponsor or his representative. The committee should examine each report of death within a time period of 30 days of receiving the reports from the respective ethics committees.