Applicants will now be required to submit finalised regulatory specifications upfront
In a move aimed at speeding up approvals for new drugs, the government has changed the way testing permissions are granted, allowing companies to begin laboratory testing immediately after filing applications instead of waiting for detailed scrutiny.
In an official circular, the country’s apex drug regulatory authority, Central Drugs Standard Control Organization (CDSCO), said it has decided that “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.”
Earlier, the regulator examined detailed specifications submitted by applicants before issuing permission for testing.
These included “Type of formulation, dosage form, Critical Quality Attributes (CQAs), and general characteristics of the product,” along with “Product development reports, forced degradation studies, and other relevant data, in accordance with applicable guidelines,” compliance with pharmacopoeial monographs, and provisions of the Drugs and Cosmetics Act, 1940.
Testing is a mandatory prerequisite before approval and is conducted at government laboratories, including the Indian Pharmacopoeia Commission (IPC), Central Drugs Testing Laboratory, Mumbai, Central Drugs Laboratory at CRI Kasauli, and National Institute of Biologicals, Noida. These labs conduct tests as per submitted specifications and submit reports to CDSCO for consideration.
The circular further stated that this move would shift the focus to faster movement of files while retaining technical scrutiny for later stages.
However, applicants will now be required to submit finalised regulatory specifications upfront. As part of the filing document, they must base specifications on “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 thereunder” and “Product Specific Quality Management System (QMS).”
The circular further clarified that “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 system will come into effect from June 1, 2026.
