India’s CDSCO Establishes New Clinical Trial Application Requirements
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India’s Central Drugs Standard Control Organization (CDSCO) issued an order on 5 September 2014 with “immediate effect” that all applications for the approval of global and new clinical trials must now include the following information:
- An assessment as to the risks versus benefit to trial subjects
- Innovation in comparison to existing therapeutic options, and
- Unmet medical need in India
The CDSCO order was sent to “concerned sponsors”—clinical research organizations (CROs), medical institutions, and industry trade associations—noting that the requirements have been imposed as a result of an order issued by India’s Supreme Court on 21 October 2013.
The Supreme Court order was prompted by a Public Interest Litigation (PIL) petition filed with the Court by the non-governmental organization Swasthya Adhikar Manch (SAM), which sought to halt the conduct of clinical trials in India for new products that would not be sold or marketed in India.