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211 deaths during clinical trials this year

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Press Trust of India New Delhi

While 668 deaths were reported in 2010 and 438 in 2011, out of these, deaths attributed only "to clinical trials" were 22 and 16 respectively.

In a written reply to a question in the Lok Sabha, Minister for Health and Family Welfare Ghulam Nabi Azad said a total of 1,954 persons died from 2009 till June 2012 due to "serious adverse events of death" in clinical trials.

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.

 

Azad, however, said deaths "attributed to clinical trials" in 2010 and 2011 after they were studied were only 22 and 16 respectively.

"The scrutiny of cases pertaining to the year 2012 is in process," the Minister said.

The Minister said compensation has been paid in all the cases pertaining to 2010, except in one case where the whereabouts of the legal heir could not be ascertained.

In respect of cases pertaining to 2011, compensation has been paid in 15 cases and in the remaining one case, issue of payment has been taken.

To a question if the recent data released by WHO shows consistently high mortality rates in clinical trials, Azad said, "The WHO has denied existence of any WHO report regarding deaths in clinical trials in India in the past few years."

He claimed that the Health Ministry has taken a number of measures to strengthen the provisions for regulating the conduct of clinical trials in the country. (MORE)

  

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First Published: Aug 17 2012 | 7:05 PM IST

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