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21 Dec 2014

India: Clinical trials continue to be a cause of concern due to ambiguity in guidelines & lack of regulation

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Despite clinical trials coming under scrutiny in various courts, little has changed on the ground. On September 30 the Supreme Court of India passed a ruling which said that no new clinical trials should be allowed for new drugs till a mechanism is put in place to monitor them. The Supreme Court also sought assessment of risk vs benefits to the patients, innovation vis-a-vis existing therapeutic options and the unmet medical needs of the country. However, recent reports have again raised concerns on clinical trials in the country. Reports reveal that there have been at least 370 deaths as a result of adverse events during clinical trials since February 2013. However, not all of them all received compensation from the government. 

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