As many as 436 people died during clinical trials in the country in 2012, of which only 16 were attributed directly to such experiments.
“As per available data, the number of serious adverse events of deaths in clinical trials reported during the last three years - 2010, 2011 and 2012 - were 668, 438 and 436, respectively,” Minister for Health and Family Welfare Ghulam Nabi Azad said in a written reply to a question in the Lok Sabha.
However, deaths attributable to clinical trials were 22, 16 and 16 respectively during these three years, he said.
The minister said government has taken a 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.
As per the rules, the investigator conducting the trial is mandated to ascertain the death and report the same to the Drugs Controller General of India, the sponsor and the Ethics Committee within 24 hours of the occurrence.
In a bid to regulate the booming clinical trial industry in India, government had earlier this month set up four committees to monitor and ensure accountability during such tests that have seen 2,242 deaths in the past five years.
So far, there was no procedure in place to ensure accountability of this hitherto unregulated sector which is worth $ 500 million in India.
