Notification/Circular No.: File No.:VAC-11011(11)/10/2025-eoffice dated September 03, 2025
Applicable Act/Rule: Drugs and Cosmetics Act, 1940 and Rules thereunder
The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, has issued a circular accepting Institutional Biosafety Committee (IBSC) approval for manufacturing test items for examination, testing, and analysis using Form CT-10. This decision follows the recommendation of the 314th Review Committee on Genetic Manipulation (RCGM) meeting held on July 9, 2025. The circular references earlier communications from the Department of Biotechnology and is intended for the information and necessary action of stakeholders involved in research and testing activities. The acceptance of IBSC approval is expected to streamline the process for entities seeking permission to manufacture test items, ensuring alignment with biosafety protocols and regulatory requirements.
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