Four hundred thirty-six lives were lost in the country in 2012 during clinical trials of drugs, averaging more than eight deaths every week, but government is yet to ascertain how many of them were due to such tests.
The number of such deaths in 2011 was 438 while in 2010 it was 668.
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. In a written reply to a question in the Lok Sabha, Health and Family Welfare Minister Ghulam Nabi Azad on Friday said the cases of 2012 are “under examination” as all such deaths are investigated to arrive at a causal relationship.
Mr. Azad said of the 480 applications received for conducting clinical trials of new drugs/vaccines on human beings in the country in 2012, 253 were granted permission for conducting the same, against 283 granted in 2011 out of 306 applications received. As many as 529 permissions for new drug trials were granted against 546 applications in 2010.
The Minister said government has taken number of steps to strengthen the approval procedures and monitoring mechanism for clinical trials and to ensure safety, rights and well-being of trial subjects, which includes the amendments notified in the Drugs and Cosmetics Rules, 1945.
In a bid to regulate the booming clinical trial industry in India, government had earlier this month set up four committees that will monitor and ensure accountability during such tests that have seen 2,242 deaths in the past five years.