Biosafety Regulatory Framework in India

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INVC,,

New Delhi,,

The Ministry of Environment and Forests (MoEF) has notified the Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989 (known as ‘Rules, 1989’) under the Environment (Protection) Act, 1986. These rules and regulations cover the areas of research as well as large scale applications of Genetically Modified Organism (GMOs) and products made there from throughout India. The rules also cover the application of hazardous microorganisms which may not be genetically modified. Hazardous microorganisms include those which are pathogenic to animals as well as plants.

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).

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