ENA Sectors 2026-02-24 17:00:10 <p><span style="font-size:14px"><strong>New Delhi, Feb 24 (KNN)</strong> Indias drug regulator is rolling back low-risk procedural requirements in clinical research and exports while strengthening enforcement on manufacturing quality, signalling a more risk-based approach to regulation.</span></p> <p><span style="font-size:14px">The Central Drugs Standard Control Organisation (CDSCO) will withdraw the requirement for export No-Objection Certificates (NOCs) for pharmaceutical shipments to stringent regulatory authority (SRA) markets, including the US, Europe, the UK, Japan, Canada and Australia. </span></p> <p><span style="font-size:14px">Exporters will now need only an automated acknowledgement, with the change to be notified shortly.</span></p> <p><strong><span style="font-size:14px">Faster Approvals, Lower Compliance Burden</span></strong></p> <p><span style="font-size:14px">The move follows earlier decisions to eliminate test licence requirements for activities up to the pre-clinical stage and to remove BA/BE NOCs for low-risk export studies &mdash; approvals that accounted for nearly half of such clearances but offered limited regulatory value.</span></p> <p><span style="font-size:14px">Drugs Controller General of India Rajeev Raghuvanshi said, For activities that carry no public health risk, there is no reason for the regulator to slow innovation, Business Standard reported.</span></p> <p><span style="font-size:14px">He added that review timelines for Investigational New Drugs (INDs) and permissions for biological trials (PBTs) have been reduced significantly, supported by mandatory pre- and post-submission meetings and quicker expert committee reviews.</span></p> <p><span style="font-size:14px">Senior-level oversight is now ensuring that IND and PBT applications are cleared within about a month, compared with earlier timelines of up to 90 days.</span></p> <p><strong><span style="font-size:14px">Stricter Manufacturing Surveillance</span></strong></p> <p><span style="font-size:14px">While easing low-risk compliance, the regulator has intensified inspections under revised Schedule M norms, expanded risk-based audits and stepped up action against not-of-standard-quality drugs.</span></p> <p><span style="font-size:14px"><em><strong>(KNN Bureau)</strong></em></span><br /> </p> 45265 https://knnindia.co.in/news/newsdetails/sectors/drug-regulator-eases-noc-norm-to-boost-pharma-exports-tightens-quality-enforcement 2026-02-24 17:00:10 knnindia.co.in