Biosafety Regulatory Framework in India
These rules also define the competent authorities and composition of such authorities for handling of various aspects of the rules. Presently there are five competent authorities that is , Institutional Biosafety Committees (IBSC), Review Committee of Genetic Manipulation (RCGM), Genetic Engineering Approval Committee (GEAC), State Biotechnology Coordination Committee (SBCC) and the District Level Committee (DLC). The RCGM established under the Department of Biotechnology (DBT) supervises research activities including small scale field trials, whereas approvals for large scale releases and commercialization of GMOs are given by the GEAC, established under the MoEF. The SBCCs and DLCs have a major role in monitoring. The Rules also mandate that every institution engaged in GMO research establish an IBSC to oversee such research and to interface with the RCGM in regulating it. The IBSC has a nominee of DBT on its Committee.
The Rules, 1989 are supported by the following bio-safety guidelines:
- Recombinant DNA Safety Guidelines, 1990 & 1994
- Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation, 1998
- Guidelines and SOPs for the conduct of Confined Field Trials of Transgenic Plant, 2008
- Guidelines for the Safety Assessment of GM Foods, 2008
- Protocol for Safety Assessment of Genetically Engineered Plants / crops, 2008.
These guidelines and protocols are being regularly updated through a consultative approach and following the international norms prescribed by the Organization for Economic Co-operation and Development (OECD), CODEX Alimentarius Commission and International Plant Protection Convention (IPPC).