New Delhi: In a move aimed at speeding up approvals for new drugs, the government has changed the way testing permissions are granted, allowing companies to start laboratory tests immediately after submitting applications instead of waiting for detailed scrutiny.
In an official circular, the country’s top drug regulatory body, the Central Pharmaceutical Standards Control Authority, said it had decided to “issue a no-objection certificate for testing drug samples in designated laboratories immediately upon receipt of applications in the relevant department.”
Earlier, the regulatory body examined the detailed specifications submitted by applicants before issuing permission for the test.
These included “type of formulation, dosage form, critical quality attributes, and general product characteristics,” along with “product development reports, forced dissolution studies, and other relevant data, in accordance with applicable guidelines,” compliance with pharmacopoeial monographs, and provisions of the Drugs and Cosmetics Act of 1940.
Testing is a mandatory requirement before approval and is conducted at government laboratories, including the Indian Pharmacopoeia Commission, Central Drug Testing Laboratory, Mumbai, Central Drugs Laboratory at CRI Kasauli, and National Institute of Biologicals, Noida. These laboratories perform tests according to the specifications provided and submit reports to CDSCO for consideration.
The circular also stated that this step would shift the focus to faster movement of files while reserving technical scrutiny for later stages.
However, applicants will now be required to submit final regulatory specifications in advance. As part of the submission document, the specification must be based on “the prevailing pharmacopoeia standards and the relevant general chapters of the pharmacopoeia, as defined in the Second Schedule to the Drugs and Cosmetics Act 1940 and the rules made thereunder” and the “quality management system for the product”.
The circular further clarified that “in cases where the specifications are revised or updated after review or feedback by CDSCO, a new NOC for testing shall be issued for re-testing in the designated laboratory as per the revised specifications.”
The new system will come into effect from June 1, 2026.
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