Testing, conducted at institutions such as the Indian Pharmacopoeia Commission and other central laboratories, remains a mandatory step before final approval.
In an official circular, the apex drug regulatory body, 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) will be issued immediately on receipt of applications in the concerned division.” Previously, the regulator examined detailed specifications submitted by applicants before granting permission for testing.
These include “Type of formulation, dosage form, critical quality characteristics (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 pharmacopoeia monographs and provisions of the Drugs and Cosmetics Act, 1940.
Testing is a mandatory pre-approval requirement and is conducted at government laboratories including Indian Pharmacopoeia Commission (IPC), Central Drugs Testing Laboratory, Mumbai, Central Drugs Laboratory at CRI Kasauli and National Institute of Biologicals, Noida. These laboratories perform testing according to submitted specifications and submit reports to CDSCO for consideration.
The circular further stated that this move would shift the focus to faster file movement while maintaining technical control for later phases.
However, applicants will now have to submit final regulatory specifications in advance. As part of the submission document, they must base the specifications on the ‘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 following review or comments by CDSCO, a new NOC for testing will be issued for retesting at the designated laboratory as per the revised specifications.” The new system will come into effect from June 1, 2026.
Published on February 26, 2026
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