Ordering immediate stoppage of clinical trials of 162 new drugs, the Supreme Court on Monday decided to review after two weeks the safety and regulatory mechanism in place to prevent further deaths of innocent victims administered drug trials.
Adding to the Court’s worry, NGO Swasthya Adhikar Manch produced further proof of deaths reported from Khammam district in Andhra Pradesh on which a Parliamentary Standing Committee prepared a report lately pointing out the deficiencies in the statutory framework resulting in death of women and children in March 2010 after being administered Human Papilloma Virus (HPV) vaccine.
The bench of Justices RM lodha and Shiv Kirti Singh sought response of the Centre on the application while ordering a ban on any further clinical trial till a mechanism to regulate clinical trials was in place.
The determination of the bench to order stay on the trial of 162 new drugs, cleared by an expert committee for it to be tested on humans, forced the Centre to voluntarily undertake stoppage of trials. Additional Solicitor General (ASG) Sidharth luthra informed the
court that the Centre was seized of an expert report prepared by Ranjit Roy Chaudhary, who was tasked by the Centre to prepare a regulatory framework.
The report also received inputs from States who took part in a meeting called by the Health Secretary on August 13. Madhya Pradesh, Rajasthan, Punjab and West Bengal were few States which suggested reforms in the procedure for the inspection of clinical trials. Besides, inputs were also received from NHRC and other NGOs.
The NHRC had recommended formation of Ethics Committee in all institutions and a standard operating procedure for conduct of such trials.
When the bench asked the Centre on why the suggestions were not implemented immediately, luthra sought two weeks to indicate how an adequate safety mechanism was sought to be put in place based on the one-man expert team’s report.
The Government in an affidavit said it had inspected 577 clinical trials and clarifications were sought in 235 cases. Of the 1,122 applications for approval of clinical trials, the New
Drug Advisory Committees recommended 285 applications for approval that included testing of drugs relating to anti-AIDS, oncology, cardiology, neurology, psychiatry, metabolism and endocrinology.