Clinical trials to get more challenging NEW DELHI: The government has proposed tougher compensation norms for injuries suffered by participants during clinical trials, a move that may come as a relief to victims but prompt drug manufacturers to shy away from conducting clinical trials in India for serious diseases. Barring totally proven unrelated cases, drugmakers will have to provide compensation for all injuries sustained by the participants, the health ministry has proposed in a new regulatory framework for clinical trials. Injuries and deaths that have possibly or probably resulted from trials will, therefore, also have to be compensated. This will bring almost all injuries that may happen during a trial under the ambit of compensation, industry executives rue, saying the new framework will prove too onerous for pharma companies to conduct trials for serious diseases. It is extremely rare in clinical trials that an injury or death can be proven to be due to totally unrelated causes. Even in the case of a road accident, involvement of effect of the medicine cannot be ruled out. In practice, this will mean that all injuries during a trial will have to be compensated, said Shoibal Mukherjee, vice president of Quintiles Research, a global clinical research organisation. Seen in the context of recommended amount of compensation up to Rs 70 lakh per case, it implies that research in the categories of most important and serious diseases such as cancer, cardiac and neurological diseases will become impossible to conduct in India, Mukherjee added. An expert committee, set up by the Drug Controller General of India, has set a range of Rs 4 lakh to Rs 74 lakh as payout in case of clinical trial related deaths, depending on age and health risks of volunteers at the time of enrolment.From 2005 to 2012, companies shelled out between Rs 1.5 lakh and Rs 4 lakh for clinical trial-related deaths, according to health ministry data. It is, however, not clear at the moment if the proposed sum will also apply to injuries resulting from clinical trials.
Posted on: Sat, 09 Nov 2013 02:34:38 +0000
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