The provision would be notified soon along with important recommendations on the quantum of compensation to be given in cases of deaths related to drug trials.
So far, investigations into death of people who participate in drug trials are done by investigators hired by firms holding such trials.
Though these hired investigators are part of the Ethics Committees which the sponsor companies conducting trials set up as part of standard protocols for conducting clinical trials, objections have been raised on their fairness and objectivity due to their conflict of interest.
The Ministry of Health and Family Welfare, which is in the process of amending the existing rules to ensure the safety of people participating in the drug trials, has now agreed in principle that every drug trial death must be independently audited.
"We are in the process of changing the existing rules or bringing new ones. The regulations certainly need to be strengthened to safeguard the interests of persons registering themselves as subjects in such trials," a top health Ministry official told PTI.
"A committee of independent auditors would be set up to investigate the cause of every death reported during the course of the clinical trial," sources in the Health Ministry said.
At present no set procedure is being followed by companies in cases of compensation for those volunteers who die during trials. MORE
