The Central Drugs Standard Control Organization (CDSCO) on February 23, 2026, issued a circular regarding the Testing of Drugs for Grant of Permissions for Import/Manufacture of New Drug for sale or for distribution and Issuance of Registration Certificate for Import of Drugs.
The Central Drugs Standard Control Organization processes applications for permission to import or manufacture new drugs and for registration of imported drugs. It evaluates product specifications based on formulation details, dosage form, critical quality attributes, development and stability data, and compliance with relevant pharmacopoeial standards under Indian law. As part of approval, samples are tested by designated government laboratories according to submitted specifications.
These designated laboratories include the Indian Pharmacopoeia Commission, Central Drugs Testing Laboratory, Central Drugs Laboratory, and National Institute of Biologicals. Their test reports are submitted to CDSCO and form a key basis for regulatory approval of the drug product.
To speed up application processing, CDSCO will now issue the No Objection Certificate (NOC) for laboratory testing immediately upon receiving an application, provided applicants submit finalized regulatory specifications aligned with prevailing pharmacopoeial standards and a product-specific quality management system. If specifications are later revised following CDSCO review, a fresh NOC will be issued for re-testing based on the updated specifications.
This revised procedure will take effect from June 01, 2026 and is intended to streamline approvals while maintaining quality and compliance requirements.
[Notification No. DCG (I)/MISC/2026 (4)]
