“436 lives were lost in the country last year during clinical trials of drugs” intimated Health and Family Welfare Minister Ghulam Nabi Azad in the Lok Sabha. He further informed that while the number of such deaths was 438 in 2011, in 2010 it was 668.
Azad said that the deaths could be due to life-threatening diseases such as cancer, heart failure and stroke or the side-effects of the drugs or their administration to terminally ill patient or critical patients. The union health ministry confirmed alleged irregularities in nine cases of clinical trials during the last three years.
In 2011, 16 deaths out of a total of 438 were due to clinical trials and in 2010 there were 22 such serious adverse events of deaths (SAE) due to drug trials and the cases of 2012 are ‘under examination’ as all such deaths are investigated to arrive at a causal relationship.
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While 253, out of 283 applications was granted permission for conducting clinical trials of new drugs & vaccines on human beings in India in 2012, in 2011 there were 306 applications, out of 480 and in 2010 it was 529, out of 546 applications that were allowed for new trial.
The Drugs and Cosmetics Rules, 1945 has been amended to strengthen the approval procedures and monitoring mechanism for clinical trials and to guarantee safety, rights and safety of trial to the patients, the Minister said.
Further, to nab the ever increasing clinical trial industry in the country, which is worth about $500 million in India as per reports, the government has set up four committees to monitor and ensure liability during such clinical tests.