Immediate NOC from June 1: CDSCO Revises Drug Testing Norms to Fast-Track Import, Manufacturing Approvals
New Delhi: The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services (DGHS), Government of India, has issued a circular streamlining the testing of drugs for regulatory approvals, with the objective of expediting the processing of applications related to the grant of permissions for import or manufacture of new drugs for sale or distribution, as well as the issuance of registration certificates for the import of drugs.
Issued vide File No. DCG (I)/MISC/2026 (4) from the office of the Drugs Controller General (India), FDA Bhawan, New Delhi, the circular outlines revised procedures for the grant of permissions for import/manufacture of new drugs for sale or distribution, and the issuance of registration certificates for import of drugs.
The Central Drugs Standard Control Organization (CDSCO) receives applications for Grant of Permissions for Import/Manufacture of New Drugs for sale or for distribution and Issuance of Registration Certificate for Import of Drugs, etc. At present, the specifications submitted by applicants are examined by CDSCO, and a No Objection Certificate (NOC) for testing is issued, considering the following:
i. Type of formulation, dosage form, Critical Quality Attributes (CQAs), and general characteristics of the product.
ii. Product development reports, forced degradation studies, and other relevant data, in accordance with applicable guidelines
ii. Compliance with relevant Pharmacopoeial Monographs
iv. Provisions of General Chapters of the Indian Pharmacopoeia (IP) or other pharmacopoeias specified in the Second Schedule of the Drugs and Cosmetics Act, 1940, and the Rules made thereunder.
As a prerequisite for approval, testing of the product to be approved is carried out by the designated laboratories, namely the Indian Pharmacopoeia Commission (IPC) in Ghaziabad, the Central Drugs Testing Laboratory (CDTL) Mumbai, CDL at CRI, Kasauli, or National Institute of Biologicals (NIB), Noida. These laboratories conduct testing as per the submitted specifications, and the test reports are submitted to CDSCO for consideration of approval of the applied products
Now in the recent notice, it is stated,
"In order to expedite the processing of applications, it has been decided that the No Objection Certificate (NOC) for testing of drug samples at the designated laboratories (IPC, Ghaziabad; CDTL, Mumbai; CDL at CRI, Kasauli; or NIB, Noida) shall be issued immediately upon receipt of applications in the concerned division. As part of the filing document, applicants shall submit their finalized regulatory specifications based on:a. Prevailing Pharmacopoeia standards and relevant general chapters of the Pharmacopoeia, as specified in the Second Schedule of the Drugs and Cosmetics Act, 1940 and the Rules made thereunderb. Product-Specific Quality Management System (QMS).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 the revised specifications."
The new provisions will come into effect from 1 June 2026, and the circular has been issued for information and necessary action to all CDSCO Headquarters divisions, the Secretary-cum-Scientific Director of IPC Ghaziabad, the Directors of CDTL Mumbai, NIB Noida, and CDL CRI Kasauli, with intimation to stakeholders via the CDSCO website and CDAC at CDSCO.
To view the official notice, click the link below:
