Manufacturer | Source: CDSCO
Published On: 03-09-2025
Enforcement Date: 03 September, 2025
Acceptance of the IBSC approval for seeking permission to manufacture test items for examination, test and analysis through form CT-10 as per the recommendation of the 314th RCGM meeting, dated 09.07.2025
Central Drugs Standard Control Organization (CDSCO) issued a circular dated 3rd September 2025, referencing the 314th RCGM meeting. It announces that Institutional Biosafety Committee (IBSC) approvals will be accepted for submitting Form CT-10 to seek permission for manufacturing test items for examination, test, and analysis specifically for Category I and II genetically engineered experiments. This streamlines regulatory procedures for biopharmaceutical manufacturers conducting R&D under the 2017 Recombinant DNA Guidelines.
The RCGM Circular dated 3rd September 2025 introduces a regulatory simplification for manufacturers conducting genetically engineered research under Category I and II experiments. It allows Institutional Biosafety Committee (IBSC) approvals to suffice for submitting Form CT-10 to the Central Licensing Authority, eliminating the need for prior RCGM clearance. This change significantly accelerates the process of obtaining permission to manufacture test items for examination, testing, and analysis. By aligning with the Recombinant DNA Guidelines, 2017, the circular promotes faster innovation while maintaining biosafety oversight. Manufacturers—especially those in early-stage R&D or academic-industry collaborations—benefit from reduced administrative delays and improved operational agility. The update reflects India’s commitment to fostering responsible biotechnology development and harmonizing with global regulatory practices. Companies engaged in biopharmaceuticals, gene therapy, and recombinant product development should update their internal protocols to leverage this streamlined pathway. It also underscores the importance of maintaining robust IBSC governance and documentation to ensure compliance and traceability.
Applicable For: Manufacturer
Reference Number: File No.:VAC-11011(11)/10/2025-eoffice [E CompoNo.:27052]
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