The number of people dying during such trials also include 1106 people whose death could be attributed to diseases like cancer, terminal illness or various unrelated causes which is also known as Serious Adverse Event (SAE) of death, Azad said in a written reply in the House.
Informing the House on clinical trial deaths in the country, Azad said, "The number of SAE of deaths in clinical trials reported during the last two years (2010-2011) were 668 and 438 respectively. However, deaths attributed to clinical trials in 2010 and 2011 were 22 and 16 respectively. "
He said the serious adverse events of death may occur during clinical trials due to various reasons, which could be attributed to deaths relating to diseases like cancer or administration of drug on critical or terminally ill patients or side-effects or unrelated causes.
The Minister also said that the Parliamentary Standing Committee on Health and Family Welfare in its report has made a number of observations on functioning of Central Drugs Standards Control Organisation (CDSCO) and had raised the issue of approval of drugs without clinical trials.
"It (the Parliamentary Committee) has also made some observations on media coverage of conduct of clinical trial on the poor and illiterate people in India and deaths of trial subjects reported during these trials," Azad added.(More)