CDSCO Fast-Tracks Lab Testing to Boost Drug Approvals in India

CDSCO lab testing approvals got a major push from the Centre as companies can now begin drug sample testing right after filing applications.

The Central Drugs Standards Control Organisation (CDSCO) issued a circular on February 23 saying No Objection Certificates (NOC) for testing at government labs will be issued immediately on receipt of applications. This replaces the old practice of waiting for detailed scrutiny before testing could start.

Testing is a key step before drug approvals and is done at four designated government labs — the Indian Pharmacopoeia Commission, Mumbai’s Central Drugs Testing Laboratory, the Central Drugs Laboratory at CRI Kasauli and the National Institute of Biologicals in Noida. These labs test as per the specifications submitted and send reports back to CDSCO for final decision.

Also Read: How Digital Maturity is Powering Pharma's GMP Evolution

Under the earlier process, CDSCO first reviewed detailed formulation specs, product development reports, and compliance with pharmacopoeia monographs before granting permission for testing. The new move, set to take effect from June 1, 2026, aims to fast?track file movement while keeping full technical scrutiny for later stages.

Applicants must submit finalized regulatory specifications based on prevailing pharmacopoeia standards and quality management systems. The circular notes that “in cases where specifications are revised or updated after review or comments by CDSCO, a fresh NOC for testing shall be issued for re?testing at the designated laboratory as per the revised specifications.”

This change comes alongside amendments to the NDCT Act to cut regulatory burden and boost Ease of Doing Business. The Union Health Ministry also dropped the need for provisional registration certificates for ethics committees and eased approval for low?risk BA/BE studies, allowing them to start with a simple online intimation to CDSCO, especially helping the generic drug sector.