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India: Journal article highlights lack of accountability of pharmaceutical companies in clinical trials

"Health Rights Litigation Pushes for Accountability in Clinical Trials in India", Dec 2014

…As an example of health rights litigation, this article highlights proceedings before the Indian Supreme Court…which addresses the lack of protection of trial subjects. The Court has shown its willingness to take this issue seriously, having urged the Indian Government to advance the regulatory framework on clinical trials. However, full enforcement of relevant standards should…also include private organizations conducting clinical trials (‘trial sponsors’) and pharmaceutical companies that benefit from the results…Less attention has been given to the legal obligations of the organizations responsible for the clinical trials. Due to a lack of legislative detail and the dearth of relevant case law, these obligations lack specific standards detailing what it means, for example, to “verify that informed consent is taken properly” or “implement a proper monitoring system.” An amicus curiae intervention in the ongoing Indian proceedings calls on the Supreme Court to clarify these standards and order European and American companies to comply…[Refers to GlaxoSmithKline, Merck, Pfizer]