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India’s Trial Approval Timelines Report Card – Some Red Lines?

 
• By Anju Ghangurde

India’s streamlined clinical trial approvals process appears to have made some gains, but top industry experts tell Pink Sheet how the non-standardized approach of Subject Expert Committees is a “major handicap” for applicants.

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India’s attempt to move towards a time-bound approach for the approval of clinical trial applications appears to have made some progress, but gaps and challenges on the ground, including those around the functioning of Subject Expert Committees (SECs), continue to set back these efforts, according to some senior industry experts

SECs advise the Indian regulator on trial-related permissions as part of a layered approval process. India currently follows a three-tier review process for clinical trials, under which applications are initially...

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