For examining the reports of serious adverse events (SAEs) of deaths occurred during the clinical trials in the country, the drug controller general of India (DCGI) Dr GN Singh has constituted three independent expert committees. Dr Arun Agarwal, Professor of ENT & dean, Maulana Azad Medical College, New Delhi is the chairman of all the three committees.
The committee will examine the reports of SAEs of deaths, to determine the cause of death. If the cause of the death is considered as clinical trial related death, the committee will give its recommendation to the DCGI. In case of clinical trial related death, the committee will also recommend the quantum of compensation to be paid by the sponsor or his representative to DCGI.
The committee will examine whether the death has been occurred due to adverse effect of investigational products; violation of the approved protocol, scientific misconduct or negligence by the sponsor or his representative or the investigator; failure of investigational product to provide intended therapeutic effect; use of placebo in a placebo-controlled trial; 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; or any clinical trial procedures involved in the study.
The committee will examine each report of death within a time period of 30 days of receiving the reports from the respective ethics committee. The chairman of the committee can invite subject and other outside experts if considered necessary. The chairman of the expert committee will receive reports of serious adverse events of deaths from investigators, sponsors or his representatives whosoever had obtained permission from the DCGI for conducting the clinical trial and ethics committees.
These independent expert committees will function under the provisions as specified in Appendix XI1 of Schedule Y of Drugs & Cosmetics (D&C) Rules.
Apart from the three seven-member committees, the DCGI has also announced a 48-member panel of experts for constituting independent Expert Committee to examine the SAE (death) occurring during the clinical trials.