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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Circular on Testing of New Drugs for Import, Manufacture, and Registration

23-Feb-2026 | File No. DCG (1)/MISC/2026 (4)

As per the Circular, CDSCO has streamlined the process for issuance of No Objection Certificate (NOC) for testing of drug samples at designated laboratories to expedite the approval process. Accordingly, upon receipt of an application in the concerned division, CDSCO shall issue the NOC for testing immediately, without awaiting detailed technical scrutiny. Applicants seeking approval for import/manufacture of new drugs or registration certificates are required to ensure the following compliance obligations: Accordingly, applicants shall ensure the following compliance requirements: 1. The applicant shall submit finalized regulatory specifications along with the application at the time of filing. 2. The submitted specifications shall be based on the prevailing Pharmacopoeial standards and relevant General Chapters as specified under the Second Schedule of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder.The specifications shall also be aligned with the applicant?s Product-Specific Quality Management System (QMS). 3. The drug samples shall be tested at the designated laboratories, namely the Indian Pharmacopoeia Commission (IPC), Ghaziabad; Central Drugs Testing Laboratory (CDTL), Mumbai; Central Research Institute (CRI), Kasauli; or National Institute of Biologicals (NIB), Noida, as applicable. 4. Testing shall be conducted as per the specifications submitted by the applicant, and the test reports shall be considered by CDSCO for approval of the applied product. 5. In case the submitted specifications are revised or updated pursuant to review comments issued by CDSCO, the applicant shall obtain a fresh NOC and arrange for re-testing of the drug samples at the designated laboratory. This circular will be effective from 1st June 2026.

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