CDSCO to fast-track drug testing clearances | India News
New Delhi: The Central Drugs Standard Control Organization this week moved to fast-track approval for new drugs by allowing issuance of no-objection certificates (NOCs) for laboratory tests upon receipt of applications — a move aimed at reducing delays in the drug approval process.Under the revised procedure, NOCs for testing new drugs in designated government laboratories will be granted in advance, without waiting for prior verification of detailed technical specifications.The change applies to applications seeking permission to import or manufacture new drugs for sale or distribution as well as registration certificates for drug imports.Earlier, CDSCO reviewed formulation details, dosage form, critical quality attributes and compliance with pharmacopoeial standards before allowing testing. Now, laboratory evaluation will begin immediately, while regulatory review will continue in parallel.Testing will be done at institutes including Indian Pharmacopoeia Commission, Ghaziabad, Central Drugs Testing Laboratory, Mumbai, Central Drugs Laboratory, CRI Kasauli and National Institute of Biologicals, Noida.Applicants are still required to submit final regulatory specifications based on existing pharmacopoeial standards and product-specific quality management systems. If the specifications are revised after review, a fresh NOC will be issued for re-examination under the updated rules.The revised regime will come into effect from June 1, 2026. The move is expected to reduce procedural hurdles while maintaining statutory quality checks for new drugs entering the Indian market.
