As many as 2,644 people, called subjects, died during the clinical trials of 475 new drugs on human beings in last seven years and only 17 of the medicines were approved for marketing in India, the Centre has informed the Supreme Court.
Responding to allegations by NGO, Swasthya Adhikar Manch, in its PIL that Indians were used as guinea pigs by foreign pharmaceutical majors for human trial of their new drugs, the Union health and family welfare ministry said of the 57,303 enrolled subjects, 39,022 completed the clinical 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," health secretary Keshav Desiraju said in an affidavit on behalf of the ministry of health and family welfare.
"Around 11,972 serious adverse events (excluding death) were reported during the period from January 1, 2005 to June 30, 2012, out of which 506 events were found to be related to clinical trials," he said.
Clinical trial of two drugs - Bayer's Rivaroxaban and Novartis's Aliskiren vs. Enalapril - accounted for maximum number of deaths. Full story...
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Responding to allegations by NGO, Swasthya Adhikar Manch, in its PIL that Indians were used as guinea pigs by foreign pharmaceutical majors for human trial of their new drugs, the Union health and family welfare ministry said of the 57,303 enrolled subjects, 39,022 completed the clinical 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," health secretary Keshav Desiraju said in an affidavit on behalf of the ministry of health and family welfare.
"Around 11,972 serious adverse events (excluding death) were reported during the period from January 1, 2005 to June 30, 2012, out of which 506 events were found to be related to clinical trials," he said.
Clinical trial of two drugs - Bayer's Rivaroxaban and Novartis's Aliskiren vs. Enalapril - accounted for maximum number of deaths. Full story...
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