Regulatory Focus™ > News Articles > India’s CDSCO Establishes New Clinical Trial Application Requirements

India’s CDSCO Establishes New Clinical Trial Application Requirements

Posted 10 September 2014 | By Louise Zornoza

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. 

 

CDSCO Order


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