India Strengthens Drug Approval Oversight with Expanded CDSCO Powers

India has enhanced its regulatory oversight by granting joint drug controllers within the Central Drugs Standard Control Organisation (CDSCO) greater authority to accelerate marketing authorisations and regulatory decisions. The move aims to streamline approvals, reduce processing timelines and enable faster access to new therapies. The newly delegated powers cover manufacturing licences, clinical trial permissions and post-approval changes, reducing the dependency on top-level clearance and helping decentralise regulatory decision-making. Authorities stated that the shift is designed to improve efficiency without compromising safety, especially as India sees rising application volumes for complex generics, biologics and novel therapies. The reform aligns with India’s broader ambition to strengthen its regulatory ecosystem in line with global benchmarks and reinforce its position as a pharmaceutical innovation and export hub.