CDSCO to fast-track drug testing clearances

NEW DELHI: The Central Drugs Standard Control Organisation this week moved to fast-track approvals for new medicines by allowing No-Objection Certificates (NOCs) for laboratory testing to be issued immediately upon receipt of applications — a step aimed at reducing delays in the drug approval process.

Under the revised procedure, NOCs for testing new drugs at designated government laboratories will be granted upfront, instead of waiting for prior scrutiny of detailed technical specifications.

The change applies to applications seeking permission for import or manufacture of new drugs for sale or distribution, as well as registration certificates for drug imports.

Previously, CDSCO reviewed formulation details, dosage form, critical quality attributes and compliance with pharmacopoeial standards before permitting testing. Now, laboratory evaluation will begin immediately, while regulatory review continues in parallel.

Testing will be conducted at institutions including the Indian Pharmacopoeia Commission in Ghaziabad, Central Drugs Testing Laboratory in Mumbai, Central Drugs Laboratory at CRI Kasauli and the National Institute of Biologicals in Noida.

Applicants must still submit finalised regulatory specifications based on prevailing pharmacopoeial standards and product-specific Quality Management Systems. If specifications are revised after review, a fresh NOC will be issued for re-testing under updated norms.

The revised system will take effect from June 1, 2026. The move is expected to ease procedural bottlenecks while maintaining statutory quality checks for new drugs entering the Indian market.
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