NEW DELHI: The Central Drugs Standard Control Organization this week started expediting the approval of new drugs by allowing the issuance of no-objection certificate (NOC) for laboratory testing immediately upon receipt of application, 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 instead of waiting for prior review of detailed technical specifications.This change applies to applications seeking permission to import or manufacture new pharmaceutical products for sale or distribution, as well as registration certificates for pharmaceutical imports.Previously, CDSCO reviewed formulation details, dosage form, critical quality attributes and compliance with pharmacopoeial standards before allowing testing. Laboratory evaluation will now begin immediately while regulatory review continues.Testing will be conducted at institutions such as Indian Pharmacopoeia Commission in Ghaziabad, Central Drug Testing Laboratory in Mumbai, Central Drug Laboratory in CRI Kasauli and National Institute of Biological Products in Noida.Applicants must still submit final regulatory specifications based on current pharmacopoeial standards and product-specific quality management systems. If the specifications are revised after review, a new NOC will be issued to allow for retesting against the updated specifications.The revised system will take effect from June 1, 2026. The move is expected to ease procedural bottlenecks while maintaining statutory quality checks on new drugs entering the Indian market.
