New Delhi, Apr 25: 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.
Bayer's Rivaroxaban was first used for human trials in 2008 resulting in death of 21 of which it claimed that only five were related to clinical trial but it has till date paid compensation to kin of only two. Two years later, the same drug was again put on human trial and this time 125 deaths were reported, of which it was stated that five were related to clinical trial.
Novartis used the investigational product listed as Aliskiren vs. Enalapril last year and it resulted in death of 47 of which only one has been attributed to clinical trial of the new drug. Only another clinical trial of new drug on humans, Sun Pharma's Paclitaxel injection concentrate for nano-dispersion, registered a double-digit death figure (12) during the last seven years. Majority of the pharmaceutical companies, whose drugs were permitted for clinical trial on human beings, were of foreign origin.
The secretary promised to the court for stringent regime on clinical trials on the recommendations of the Parliamentary Standing Committee, which faulted the Drugs and Cosmetics (Amendment) Bill, 2007.
He said: "On the advice of the ministry of law, the health ministry has proposed to withdraw the 2007 Bill and introduce a new Bill in its place after incorporating the recommendations of the Standing Committee. Accordingly, the ministry will introduce Drugs and Cosmetic (Amendment) Bill, 2013 in Parliament during the Budget session."
On January 3, the apex court had pulled up the Centre for its insensitivity to scores of deaths and serious adverse effects to thousands during clinical trial of new drugs and asked the health secretary to monitor implementation of the supervisory and scrutiny mechanism for human experiment of new drugs.
Referring to a parliamentary committee's stinging report pointing out involvement of foreign pharmaceutical multinational companies in a big way in the clinical trial of new drugs and the need for a thorough review of the existing mechanism, a bench of Justices R M Lodha and A R Dave had said, "The government has slipped into a deep slumber and doing nothing."
It was about to issue an order banning all fresh clinical trial of new drugs on humans, but additional solicitor general Siddharth Luthra had pulled out the government from an embarrassing spot by promising that the health secretary would personally monitor implementation of the new stricter regime.
The health secretary stressed the importance of clinical trials of new drugs on humans. "During the last 40 years, about 900 drug molecules of different therapeutic categories have been approved for marketing in India. Out of these 900, only seven drug molecules have been discovered and approved in India. Rest of them are discovered and developed in other countries like US, EU, Japan after going through complex process of research and drug development including clinical trial in human beings," he said.
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