The Central Drugs Standard Control Organisation (CDSCO) has announced a procedural change that simplifies the requirement for biopharmaceutical manufacturers seeking permission to produce test items for examination, test, and analysis.
Effective immediately, biopharma manufacturers will be able to use the approval from their Institutional Biosafety Committee (IBSC) when submitting Form CT 10 for manufacturing permission, provided the process falls under specific experimental categories. This decision follows a recommendation made during the 314th meeting of the Review Committee on Genetic Manipulation (RCGM) on July 9, 2025.
Background and Regulatory Change
The change addresses a redundancy in the previous approval process. According to the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017:
- Category I experiments can begin after informing the IBSC.
- Category II experiments require IBSC approval and an intimation to the RCGM.
- Category III and higher experiments require prior authorization from IBSC and subsequent approval from the RCGM.
Despite these guidelines, biopharma industries were often submitting Form CT 1 for RCGM consideration for Category I and II R&D experiments and then submitting the RCGM approval letter to the CDSCO as part of their Form CT 10 application for manufacturing test items.
New Procedure
To eliminate this unnecessary step, the Department of Biotechnology (DBT) requested the Drug Controller General of India (DCGI) to accept IBSC approval directly for applications submitted through Form CT 10.
As a result, the CDSCO has now directed that for test items generated using Category I and Category II Genetic Engineering (GE) experiments, as defined in the 2017 regulations, manufacturers can now submit their IBSC approval in lieu of RCGM approval when seeking permission to manufacture test items for examination, test, and analysis.
This measure is expected to speed up the process for research and development activities involving lower-risk genetic engineering experiments in the biopharmaceutical sector. The circular has been disseminated to all biopharmaceutical manufacturers, including those producing vaccines, r-DNA products, and others.