New rules seek compensation for clinical trial deaths

Faced with criticism on its clinical trial regulations,the Ministry of Health and Family Welfare has undertaken a slew of measures to streamline them

Faced with criticism on its clinical trial regulations,the Ministry of Health and Family Welfare has undertaken a slew of measures to streamline them,the most important being a proposed change in the rules of the Drugs and Cosmetics Rules 1945,which mandaates that in case of a death or grievous injury during a clinical trial,it will be held to have happened because of the trial,unless otherwise proved.

The other changes on the anvil include mandatory registration of the ethics committees with the Central Drugs Standard Control Organisation,empowering the CDSCO to hold periodic inspections of clinical trials and a rule that no institution which does not have its own ethics committee can hold clinical trials. The draft rules on compensation have been put up on the CDSCO website and comments from stakeholders invited within 45 days.

The rules say: In the event of injury or death occurring during the trial,the sponsor or his representative shall prove before the Ethics Committee that the injury or death is not on account of the clinical trial within 30 days of receiving the report of injury or death from the investigator; failing which sponsor shall be liable to provide the compensation within 60 days as decided by the Ethics Committee.

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Said a senior official in the Health Ministry: The existing rules have provision for compensation but it is not clearly laid out when a participant is eligible for it. The usual practice is for investigators to simply say that the death or injury was because of the disease and the matter is deemed to end there. But now they will have to prove that in front of experts and the default conclusion in case of a casualty will always be that it was because of the trial.

Registration of ethics committees is being made mandatory to avoid trials getting clearances from fly by night committees that have little credibility and are often not even a part of the hospital setup.

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