Clinical trial law runs into fresh trouble
Under the proposed law, the onus of proving that clinical trials did not cause death or injury, was expected to lie with the drug company. Failure to pay up the compensation within a specified time would have not only led to suspension or cancellation of the ongoing trials, but in more severe cases could have resulted in a permanent ban on the pharma company as well as the clinical research organisation (CRO).
The amount of compensation was to be decided on a case-to-case basis by an ethics committee, while the quantum of minimum compensation, according to the draft, was to be mentioned in the informed consent form that the pharma company gets signed by the volunteer before enrolling him for a trial. The industry, which has had two rounds of discussion with health ministry on the matter, claims that there are too many loose ends in government’s plan.
“Firstly, the members of the ethics committee, comprising lawyers, policemen and one or two clinical pharmacologists, are neither qualified nor ready to take up this task of establishing causality of death,” the head of a multinational CRO told FE.
“We have suggested that in case
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