DCGI Pushes Reforms, Drug Approvals Now Within 150 Days

New Delhi: India's drug regulatory authority has significantly cut down approval timelines by more than 50% and simplified several key regulatory norms in a move intended to boost innovation and enhance ease of doing business in the pharmaceutical sector.

According to a recent media report in the Economic Times, data for the calendar year 2025 indicate that clinical trial approvals are now being processed within 120–135 days, while marketing authorizations are granted in less than 150 days.

Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi stated, "No application exceeded the 150-day mark during the year, marking a significant improvement from earlier timelines."

He further noted that a range of structural reforms have been introduced, which are expected to create a lasting positive impact on pharmaceutical innovation.

ET reports that Raghuvanshi also highlighted that the regulator has relaxed the research framework by eliminating the need for prior approval at the pre-clinical stage, thereby facilitating faster and more flexible drug development processes.