India's Drug Regulator Halves Approval Timelines to Boost Innovation
Drug regulator halves approval timelines, eases several rules
The Economic Times
Image: The Economic Times
India's drug regulatory authority has significantly reduced approval timelines by over 50%, now granting clinical trial approvals within 120-135 days and marketing authorizations in under 150 days. These reforms aim to enhance innovation and ease of doing business in the pharmaceutical sector.
- 01Approval timelines for clinical trials reduced to 120-135 days.
- 02Marketing authorizations now cleared in under 150 days.
- 03No applications exceeded the 150-day mark in 2025.
- 04Regulatory framework has been liberalized by removing pre-clinical approval requirements.
- 05These changes are expected to have a long-term positive impact on innovation.
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India's drug regulatory authority, led by Drug Controller General Rajeev Singh Raghuvanshi, has announced a significant reduction in approval timelines for clinical trials and marketing authorizations. Clinical trial approvals are now granted within 120-135 days, while marketing authorizations are cleared in under 150 days. In 2025, no application exceeded the 150-day mark, showcasing a marked improvement from previous timelines. The reforms include the removal of the requirement for regulatory approval at the pre-clinical stage, aimed at fostering innovation in the pharmaceutical sector. These structural changes are designed to enhance the ease of doing business and are expected to have a lasting impact on the industry.
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These changes will likely accelerate the development of new drugs, benefiting pharmaceutical companies and potentially leading to faster access to innovative treatments for patients.
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