The Central Drugs Standard Control Organization (CDSCO) examines applications for grant of permission for import or manufacture of new drugs for sale or distribution and for issuance of registration certificates for import of drugs. Earlier, testing of products proposed for approval was conducted at designated laboratories before approval based on submitted specifications and reports. The present circular introduces a procedural change to expedite processing of applications while maintaining compliance with pharmacopoeial standards and quality requirements.

1. No Objection Certificate (NOC) for testing of drug samples at designated laboratories (Indian Pharmacopoeia Commission, Ghaziabad; Central Drugs Testing Laboratory, Mumbai; CDL at CRI, Kasauli; or National Institute of Biologicals, Noida) shall be issued immediately upon receipt of applications in the concerned division to expedite processing.
2. Applicants shall submit finalized regulatory specifications as part of filing documents based on:
   • Prevailing pharmacopoeia standards and relevant general chapters of pharmacopoeia specified in the Second Schedule of the Drugs and Cosmetics Act, 1940 and Rules made thereunder.
   • Product-specific Quality Management System (QMS).
3. 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 revised specifications.