SDG 3: Good Health and Well-being | SDG 9: Industry, Innovation and Infrastructure
Institutions: Ministry of Health and Family Welfare
India’s Union Health Ministry has announced proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aimed at reducing regulatory burden and accelerating research outcomes. Published in the Gazette on 28 August 2025 for public consultation, the reforms replace test license approvals with a notification-based approach—excluding certain high-risk drugs—cutting processing time from 90 to 45 days. Similarly, BA/BE (Bioavailability/Bioequivalence) study applications may proceed with simple intimation to the Central Licensing Authority, eliminating formal licensing requirements for specified categories. The changes are expected to reduce the volume of licensing applications by approximately 50 percent, enabling faster initiation of critical clinical research. The shift also allows the Central Drugs Standard Control Organization to better allocate its workforce, enhancing regulatory efficiency and supporting India’s goal of emerging as a global pharmaceutical research hub.
Relevant Question for Policy Stakeholders: What supportive infrastructure such as digital portals, clear staff guidelines, and stakeholder outreach is needed to ensure these amended NDCT rules translate into faster yet dependable clinical testing and innovation ecosystems?
Follow the full news here:
https://www.pib.gov.in/PressReleasePage.aspx?PRID=2163255