Drug regulator halves approval timelines, eases several rules

India's drug regulatory authority has reduced approval timelines by over 50% and eased key regulatory requirements, in a move aimed at accelerating innovation and improving ease of doing business.

Data from calendar year 2025 show that clinical trial approvals are now being granted within 120-135 days, while marketing authorisations are cleared in under 150 days. "No application exceeded the 150-day mark during the year, marking a significant improvement from earlier timelines," said Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi.

He said that a series of structural reforms have been designed which will have a long term impact on innovation.


Raghuvanshi added that the regulatory authority has liberalised the research framework by removing the requirement for regulatory approval at the pre-clinical stage.