CDSCO eases NOC norms to speed up clinical research and pharma exports

India's drug regulator is withdrawing export NOC requirements for SRA markets and easing other low-risk approvals, even as it strengthens oversight of manufacturing quality

India’s drug regulator is dismantling low-value regulatory barriers in clinical research and exports, even as it tightens enforcement on manufacturing quality, signalling a more risk-calibrated approach to oversight.

 

The Central Drugs Standard Control Organisation is set to withdraw the requirement for export No-Objection Certificates (NOCs) for pharmaceutical shipments to stringent regulatory authority (SRA) markets such as the US, Europe, the UK, Japan, Canada and Australia.

 

The change will be implemented through a notification, with exporters required to obtain only an automated acknowledgement.

 

The move follows earlier steps, including the elimination of test licence requirements for all activities up to the pre-clinical stage, and the removal of BA/BE NOCs for low-risk export studies — approvals that previously accounted for nearly half of all such clearances while adding limited regulatory value.

   

“For activities that carry no public health risk, there is no reason for the regulator to slow innovation,” Drugs Controller General of India Rajeev Raghuvanshi said, underlining the regulator’s intent to focus resources where risk to patients is real.

 

According to Raghuvanshi, the easing of NOC norms is part of a broader effort to streamline clinical development without weakening scientific scrutiny.

 

Review timelines for Investigational New Drugs (INDs) and permission for biological trials (PBTs) have already fallen sharply, helped by mandatory pre- and post-submission meetings and faster convening of expert committees.

 

Files are no longer parked waiting for fixed committee cycles, he said, adding that senior-level oversight is being used to ensure that IND and PBT applications do not remain pending beyond a month — a significant shift from earlier timelines that stretched to around 90 days.

 

The regulator has been clear that deregulation is being paired with tougher enforcement elsewhere. While low-risk procedural controls are being dismantled, manufacturing inspections under revised Schedule M, risk-based audits, and enforcement actions linked to not-of-standard-quality drugs have intensified.