The fate of 157 government-approved global clinical trials seemed uncertain on Monday with the Supreme Court ordering the Centre to wait for its nod while the authorities re-examine the cases under the new regulatory regime and satisfy the court on the issue of safety of the subjects and their benefits to India.
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 157 of the 162 approved trials through the stringent new three-tier test.
The Indian Express had reported that of the 162 approvals granted by the Drug Controller General of India till August 31 this year,157 trials were cleared in 2012,after a nod from just the New Drug Advisory Committees (NDACs). This meant they escaped the new regulatory regime the three-tier test which was put in place following the SCs order in January.
Only five trials were cleared from January 1-August 31 this year,when the requests were also examined by the technical and apex committee,besides the NDACs.
After Additional Solicitor General Sidharth Luthra admitted that 157 approvals 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 clarified that it will not pass any order on carrying out these 157 trials till it is satisfied that the safety of the subjects was not being jeopardised and 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 adhering to the principle of confidentiality.
Luthra assured that administrative orders or amendments in the relevant rules shall be considered by the government to ensure audio-video recording in all the cases even as the bench cautioned that any laxity or inaction by them would only delay the trials.
The court also said the contention that investigators,who inquire into cases of adverse events during and after such 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. Luthra concurred with the court and said the government would consider this suggestion.
In March,the Centre had disclosed that at least 80 people had died due to illegal clinical trials in the last seven years. It said there were 2,644 serious adverse events of deaths during clinical trials during 2005-2012. Of these,80 have been attributed to clinical trials,while the other deaths could be due to terminal illnesses or other life-threatening diseases.