The fate of 157 government-approved global clinical trials seemed uncertain on Monday as the Supreme Court ordered the Centre to wait for its nod while the authorities re-examined the cases under the new regulatory regime.
Making it clear that clinical trials being conducted in India must be done for the benefit of the people here, a bench of Justices R M Lodha and S K Singh directed the government to put the trials through the new stringent three-tier test.
The Indian Express had reported that of the 162 approvals granted by the Drug Controller General of India until August 31 this year, 157 trials were cleared in 2012, after a nod from just the New Drug Advisory Committees (NDACs). They escaped the new regulatory regime — a three-tier test involving the NDACs, technical committee and apex committee — which was put in place following the SC’s order in January.
Between January 1and August 31 this year, only five trials were cleared under the new three-tier test.
After Additional Solicitor General Sidharth Luthra admitted that 157 trials were not evaluated by the technical and apex committees, the bench asked him to get it done, and submit the reports to the court by December 16.
“The committees shall keep in view all the relevant aspects of clinical trials and efficacy data, particularly in terms of assessment of risk vs benefits to patients, innovation vis-a-vis existing therapeutic options, and medical needs of the country,” it said.
The bench said it would not pass any order on carrying out these 157 trials until it was satisfied that the safety of the subjects was not being jeopardised, and that the trials would benefit India.
On the remaining five trials, the bench said they could be proceeded with, but only after “proper framework is in place concerning audio-video recording for informed consent of the subjects and presentation of requisite documents while simultaneously adhering to the principle of confidentiality”.
The court said the contention that investigators, who inquire into cases of adverse events during and after trials, were hired by the pharmaceutical companies and were paid by them, was an “area of concern”.
“If investigators are paid by the companies, there is likelihood that serious adverse events will not be duly reported. Let there be a panel of independent investigators who can be paid by the government and the list of such persons can be updated periodically,” it said.