157 clinical trials blocked by Supreme Court
While hearing PILs filed by a doctor Anand Rai and NGO Swasthya Adhikar Manch, alleging large-scale clinical drug trials across the country by multinational pharmaceutical firms using Indian citizens as guinea pigs in those tests, a Supreme Court bench of Justices R M Lodha and S K Singh has said that no trial of new drugs be allowed till consent of people subjected to trial is recorded in audio/visual medium. The petition also alleged that the clinical trials by several pharmaceutical companies were going on indiscriminately in various states.
Observing that the clinical trials in the country must be for the help of people in India and not for the benefit of multinational companies, it allowed the trial for five entities but refused to pass order on 157 drugs which were allowed by the Centre in the year 2013. The fate of 157 government-approved global clinical trials seemed uncertain as the apex court ordered that the technical and apex committees set up by the Centre for this purpose must clear the clinical trials for the 157 drugs with recent amendments to the Drugs and Cosmetics Act after earlier directions of the Supreme Court.
The apex court was of the view that the norms formulated by the Centre were not up to the mark to protect the rights of the subjects. The bench stated that only after the reports of the technical and apex committees are submitted, it can pass order regarding 157 drugs. It directed the committees to evaluate the application for clinical trials of drugs and take decisions by assessing risk and benefit aspects and their medical needs. Directions were also issued to the government to appoint a panel of investigators for investigating the cases of clinical trials.
The bench expressed immense discontent against multinational companies conducting trials in India by not following the spirit of the law and criticized the Centre for not able to curb such practices which caused deaths. Observing these loopholes, the court ordered that all drug trials will be done under the supervision of the Union Health Secretary.
According to a report, after the New Drug Advisory Committees (NDACs) consent out of the 162 approvals granted by the Drug Controller General of India until August 31 this year, 157 trials were cleared in 2012. They did not go through a three-tier test involving the NDACs, technical committee and apex committee, a new regulatory regime which was put in place following the Supreme Court’s order in January.
Expressing its concern over the fact that companies were paying investigators leading to many adverse events going unreported, the bench was of the view that there be a panel of independent investigators who can be paid by the government and the list of such persons can be updated periodically.
The Additional Solicitor General Sidharth Luthra admitted that 157 trials were not evaluated by the technical and apex committees, which the bench asked him to get it done, and submit the reports to the court by December 16. The bench further ordered that the committees shall keep in view all the relevant aspects of clinical trials and efficacy data, assessment of risk, benefits to patients, existing therapeutic options, and medical needs of the country.