Drug Regulator Eases NOC Norm To Boost Pharma Exports; Tightens Quality Enforcement

New Delhi, Feb 24 (KNN) India’s 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.

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. 

Exporters will now need only an automated acknowledgement, with the change to be notified shortly.

Faster Approvals, Lower Compliance Burden

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 — approvals that accounted for nearly half of such clearances but offered limited regulatory value.

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.

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.

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.

Stricter Manufacturing Surveillance

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.

(KNN Bureau)