Risk Analysis Framework, 2016

The Government of India has recognised the potential for modern biotechnology to contribute to society and has acknowledged the concerns of stakeholders over development and deployment of this technology. In India, the manufacture, import, research and release of genetically modified organisms (GMOs), as well as products made by the use of such organisms are governed by rules notified by the Ministry of Environment, Forest and Climate Change (MoEF&CC), on December 5, 1989, under the Environment (Protection) Act 19861 . The Rules for Manufacture, Use, Import, Export and Storage of Hazardous Micro-Organisms, Genetically Engineered Organisms or Cells, commonly referred to as “Rules 1989,”2 cover the areas of research, including confined field trials (CFTs) as well as large-scale applications of genetically engineered organisms (GEOs) and products made from GEOs, throughout India. The regulatory agencies responsible for implementation of the Rules 1989 are MoEF&CC, the Department of Biotechnology (DBT) and State Governments, through six competent authorities:

  • Recombinant DNA Advisory Committee (RDAC)
  • Institutional Biosafety Committees (IBSC)
  • Review Committee on Genetic Manipulation (RCGM)
  • Genetic Engineering Approval Committee (GEAC)
  • State Biotechnology Coordination Committees (SBCCs)
  • District Level Committees (DLCs)

This Risk Analysis Framework provides guidance about the approach used by these Regulatory Agencies in applying risk analysis. It is the primary risk analysis reference for regulatory staff and may also be useful to a range of stakeholders including:

  • developers of genetically engineered GE plants
  • government agencies involved in regulating GE plants
  • experts who provide advice to the Regulatory Agencies regarding GE plants
  • regulators of GE plants from other international jurisdictions
  • individuals and groups interested in the regulation of GE plants in India