–SC seeks govt affidavit in 4 weeks on drug clinical trial deaths
–Drug clinical trial death cases “very serious”
–Will take more steps if clinical drug trial deaths continue
–Why not compensate severely hit drug trial subjects also
–Petitioner to SC: Over 3,000 drug clinical trial deaths 2012, 2013
–Centre to SC: Only 89 drug clinical trial deaths in 2012, 2013.
NEW DELHI: Observing that deaths of subjects during clinical trials of drugs was “very serious”, the Supreme Court today sought an affidavit from the government on the numbers on deaths and other severe adverse effects caused by such trials and said it may take more steps if required.
The directions came after the court found discrepancies in the numbers given by the petitioner non-government organisation and the government.
While the petitioner claimed that in 2012 and 2013, there were a total of around 4,000 cases of severe adverse effects of drug trial subjects, including deaths, the government claimed that the figure stood at 506, with 89 cases of deaths.
The court also observed that compensation was granted only to kin of those who died during the trials and asked why compensation should not be paid to those who were severely affected but were alive.
The court asked the government to file an affidavit, in four weeks, answering the questions and said the case will be heard after that. During the hearings, the court observed it will take additional steps if cases of adverse effects are not controlled.
The court also asked the government if it was following the directions issued earlier, which mandated that approvals for clinical trials of drugs should be granted on only three parameters–risk vs benefits, innovation, and India’s medical need.
The court had also earlier directed the government to ensure audio-visual recording of consent of clinical trial subjects. The Supreme Court is hearing public interest litigation seeking directions for regulation of clinical trials of new drugs and chemical entities.
The court had earlier restrained the government from proceeding with clinical trial of 157 new drugs and later allowed to consider the applications on the three parameters.
The plea filed by non-government organisation Swastha Adhikar Manch had sought a complete ban on clinical trials of new chemical entities, which have not yet been approved as drugs.
The petitioner also submitted an “illustrative” list of companies that have been conducting clinical trials of new chemical entities.
The companies in the list include Novartis, Sanofi, AstraZeneca Pharma, GlaxoSmithKline and Bayer HealthCare.