Under Biosafety Research programme main emphasis is given to facilitate the implementation of biosafety procedures, rules and guidelines under Environment (Protection) Act 1986 and Rules 1989 to ensure safety from the use of Genetically Modified Organisms (GMOs) and products thereof in research and application to the users as well as to the environment. A three tier mechanism comprising Institutional Biosafety Committees (IBSC) at the Institute/ company; the Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology; and the Genetic Engineering Approval Committee (GEAC) in the Ministry of Environment & Forests (MoE&F)for granting approval for research and development activities on recombinant DNA products, environmental release of genetically engineered (GE)crops and monitoring and evaluation of research activities involving recombinant DNA technology has been established.Applications in pharma/ agriculture sectors for import/ export/ transfer / exchange of GE materials including GE seeds, conduct of pre-clinical toxicity studies, evaluation of pre-clinical study reports and recommendations to DCGI for appropriate phase of clinical trials of new drug(s) or similar biologics, confined field trials on GE crops etc., were examined by the RCGM and appropriate decisions were taken. RCGM has taken several policy decisions on biosafety research on agricultural/ bio-pharmaceuticals / industrial products.
For further information click on Indian GMO Research Information SystemBiosafety data Links:
- Schedule of RCGM Meeting
- Application Formats
- Checklist for information requirements in Form C3 and C5 to RCGM- PCT application and PCT Report on Similar Biologics
- Minutes of the RCGM Meetings
- DBT invites comments/ suggestions on draft documents titled ‘‘Environmental release of GEM: Regulatory requirements for risk assessment and approval in India, 2018” and “Guidelines and Protocols for analysis of effects of GE plants on soil microorganisms, 2018