The Supreme Court on Monday directed the Centre to supply details regarding the number of deaths and harmful adverse effects caused by clinical drug trials conducted in the country for the period from July 2012 to December 2013.
The information became crucial for consideration after a PIl filed by Swasthya Adhikar Manch revealed to court crucial data relating to deaths and serious adverse effects caused to patients who underwent clinical drug trials post June 2012. The period is crucial since the Health Ministry had claimed to put in place a regime to bring drug trials under controlled supervision of an expert body.
The NGO in an affidavit informed the court that according to Government figures, a total of 89 people died during drug trials. Of them, 80 died between January 2005 and June 2012, while nine during the period from July 2012 to December 2012. However, no figures were made available for the period from January 2013 to December 2013.
A table produced in the affidavit indicated that during the trials between January and December 2013, 590 people died. The Government claimed these deaths to be as a result of the disease they suffered from and not as a consequence of drug trial. Further, the court wished to know that during January 2012-June 2012 when 475 new chemical entities got cleared, about 506 subjects developed serious adverse effects. “There is nothing to indicate these 506 got compensation. They are as serious as deaths,” said the bench of Justices RM lodha and Kurian Joseph.
The petitioner NGO represented by advocate Sanjay Parikh raised doubts over the veracity of these figures and demanded a frank response from court. While ordering the Centre to provide information on deaths and serious adverse effects (SAE) caused by drug trials, the bench said, “As to whether the new regime has been successful in reducing deaths and SAE, it is necessary the Union provides information about deaths taken place and SAE due to approval of new chemical entities from July 1, 2012 to December 31, 2013.”
The court further wished to know from Centre if the three parameters set by court for drug clearance were adopted by the Technical Committee in its latest decision to clear 157 new drugs.