Monday, November 29, 1999

728 deaths during clinical trials in last 3 years

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New Delhi, May 4 (PTI) Seven hundred and twenty eight deaths were reported during clinical trials in the country over the last three years, the Rajya Sabha was informed today. Replying to a written question in the Upper House, Minister of State for Health and Family Welfare, Dinesh Trivedi said 132 deaths were reported in 2007, 288 in 2008 and 308 till August 2009. Deaths may occur due to various reasons including during clinical trials of medicines for diseases like cancer or side-effects or unrelated causes. Such deaths are investigated for casual relationship by investigator and by medical monitor of sponsor, he said. The minister, however, added there exists adequate provisions under the Drugs and Cosmetics Act and Rules to regulate clinical trials in the country. Further, steps have been taken to make it mandatory to register all clinical trials permitted on or after the said date at the Indian Council of Medical research registry, draft guidelines and requirements for registration of organisation conducting clinical trial in the country for incorporation into the Drugs and Cosmetics Rules, the minister said.

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