668, 438 & 211 respectively.deaths during clinical trials reported in the last three years viz. 2010, 2011 & up to June 2012
28 aug tuesday
The Serious Adverse Events (SAEs) of deaths may occur during clinical trials due to various reasons. These deaths could be due to life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure / stroke and other serious diseases. They could also be due to the side-effects of the drugs or their administration to critically or terminally ill patients. Such deaths are investigated to arrive at the causal relationship if any. As per available data, the number of Serious Adverse Events of deaths during clinical trials reported in the last three years viz. 2010, 2011 & up to June 2012 are 668, 438 & 211 respectively. However, SAEs of death due to clinical trials were 22 & 16 in 2010 and 2011 respectively.
Compensation has been paid in all cases pertaining to 2010, except in one case in which it remained unpaid as whereabouts of the legal heir could not be ascertained. Similarly in respect of cases pertaining to 2011, compensation has been paid in 15 cases.
Action is taken against the pharmaceutical companies that violate the condition of approval of clinical trials as per provisions of the Drugs & Cosmetics Rule.
The above information was given by the Union Minister for Health & Family Welfare Ghulam Nabi Azad in a written reply in the Rajya Sabha