GE experiments can approach regulator with IBSC nod: DBT

THE biopharmaceutical manufacturers of products such as vaccines, recombinant DNA, and others, can approach the central drug regulator with the approval of Institutional Biosafety Committee (IBSC) for manufacturing of test items for examination, test and analysis if the test item is generated using lower risk genetic engineering (GE) experiments, rather than taking one more approval from the Review Committee on Genetic Manipulation (RCGM).

- Gireesh Babu, New Delhi

The Central Drugs Standard Control Organisation (CDSCO) has shared the clarification from the Department of Biotechnology (DBT) with the biopharmaceutical manufacturers in a circular.

The DBT has recently requested the Drug Controller General of India (DCGI) to accept IBSC approval from biopharma industries for submission of form CT 10 in cases where the test item is generated using Category I and Category II GE Experiments as defined in the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017.