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