By Sushmi Gey| December 15, 2014
NEW DELHI: Despite clinical trials coming under scrutiny in various courts, little has changed on the ground. At least 370 deaths have been reported during clinical trials in India since February 2013, but compensation has been paid in only 21 cases, according to government data. The amount ranged from Rs 4 lakh to Rs 40 lakh, a senior official told TOI.
Of the 370 deaths, 222 (60%) cases have been examined so far by a regulatory panel on clinical trials. Of these, only 21 were eligible for compensation as the the drug under trial was found to have caused the deaths, the official said.
Medical experts, however, say there is lack of clarity on the norms on which eligibility for compensation is decided. It is largely subjective, they point out, and the basic data comes from the very investigators who are involved in conducting the trial. Hence, it is not only possible for them to influence or manipulate data, there is hardly any wherewithal with the regulatory agencies to check its authenticity.
From: The Times of India