The Indian government has introduced new regulations to significantly speed up the approval timeline for clinical trial permissions related to new drug manufacturing. The revised rule mandates that applications for permission to conduct clinical trials, bioavailability or bioequivalence studies, and new drug manufacturing must be processed within 90 working days.

If regulatory authorities do not respond within this timeframe, approval is automatically deemed granted, helping to reduce unnecessary delays and providing much-needed certainty to the pharmaceutical sector.

These reforms are already gaining traction in the global clinical research community. For instance, Takeda Pharmaceutical of Japan is considering using India as a destination for global clinical trials to accelerate drug launches, buoyed by India’s diverse patient populations, cost-efficiency, and expanding hospital networks.

By rationalising timelines and enabling deemed approvals, the new policy is expected to make India a more attractive destination for clinical development. This will not only boost the speed and efficiency of drug trials but also bolster India’s position in the global pharmaceutical innovation landscape.