NEW DELHI: After ensuring that multinational pharmaceutical majors compensate those who die during clinical trials of their new drugs, the Supreme Court on April 22 2014 pulled up the Centre for not forcing the sponsors to provide similar relief to those suffering serious adverse effects during such trials. Taking up PILs seeking stringent yet transparent guidelines and norms for conduct of clinical trials in India, a bench of Justices R M Lodha and Kurian Joseph asked additional solicitor general Sidharth Luthra for details on compensation paid to patients adversely affected during clinical trial of new drugs.
The health ministry had responded to allegations by NGO, Swasthya Adhikar Manch, that Indians were used as guinea pigs by foreign pharmaceutical majors for human trials of their new drugs and said of the 57,303 enrolled subjects, 39,022 completed the trials. "Serious adverse events of deaths during the clinical trials during the said period were 2,644, out of which 80 deaths were found to be attributable to the clinical trials," the ministry had said. Luthra said kin of all 80 patients, who died because of adverse effects, were compensated by the sponsors.