Divisions

Division

Genetic Engineering Approval Committee (GEAC)

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Updated On: 01-06-2016

Genetic Engineering Approval Committee (GEAC)

Reconstitution of the Genetic Engineering Appraisal Committee[PDF](149.64 KB)

 

Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro Organisms/ Genetically Engineered Organisms or Cells

Biosafety concerns have led to the development of regulatory regimes in various countries for research, testing, safe use and handling of GMOs and products thereof. India is one of the earliest countries to establish a biosafety system for regulation of GMOs. The Ministry of Environment, Forest & Climate Change  (MoEFCC) has notified the Rules for Manufacture, Use/Import/ Export & Storage Of Hazardous Micro Organisms/ Genetically Engineered Organisms or Cells, 1989 through Notification No. 621 in Official Gazette of Govt. of India with a view to protecting environment, nature and health in connection with application of gene technology and micro-organisms.

These rules commonly referred as ‘Rules 1989’ cover areas of research as well as large scale applications of GMOs and their products including experimental field trials and seed production.

Rules 1989 are supported by the following bio-safety guidelines which have been developed 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) etc.

  • Recombinant DNA Safety Guidelines, 1990 & 1994
  • Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation, 1998
  • Guidelines for Generating Preclinical and Clinical Data for rDNA Vaccines, Diagnostics and other Biologicals, 1989
  • Guidelines and Safe Operating Practices (SOPs) for Confined Field Trials of Regulated Genetically Engineered Plants (GE)
  • Guidelines for the Safety Assessment of Foods derive from Genetically Engineered Plants, 2008 (Updated 2012)             
  • Protocols for Food and Feed Safety Assessment of GE crops, 2008.
  • Guidelines and Handbooks for Institutional Biosafety Committee 20011.
  • Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2012

The Rules 1989 also define the competent authorities and composition of such authorities for handling of various aspects of the Rules.  Presently there are six committees.  The mandate of the six Committees notified under Rules 1989 is as follows:

  • Recombinant DNA Advisory Committee (RDAC): The functions are of an advisory nature and involve review of developments in biotechnology at national and international levels and recommend suitable and appropriate safety regulations for India in recombinant research, use and applications from time to time.
  • Review Committee on Genetic Manipulation (RCGM) established under the Department of Biotechnology, ministry of Science and technology  is to monitor the safety related aspects in respect of on-going research projects and activities (including small scale field trials) and bring out manuals and guidelines specifying procedure for regulatory process with respect to activities involving geneti­cally engineered organisms in research, use and applications including industry with a view to ensure environmental safety.
  • Genetic Engineering Appraisal Committee (GEAC) established under MoEFCC is the apex body to accord notified under Rules 1989. For approval of activities involving large scale use of hazardous microorganisms and recom­binants in research and industrial production from the environ­mental angle. The GEAC is also responsible for ap­proval of proposals relating to release of genetically engineered organisms and products into the environment including experimen­tal field trials (Biosafety Research Level trial-I and II known as BRL-I and BRL-II).
  • State Biotechnology Coordination Committee (SBCC’s) have a major role in monitoring. It also has powers to inspect, investigate and take punitive action in case or violations of statutory provisions.
  • District Level Committees (DLCs) have a major role in monitoring the safety regulations in installations engaged in the use of genetically modified organisms/hazardous microorganisms and its applications in the environment.
  • Institutional Biosafety Committee (IBSC) is established under the institution engaged in GMO research to oversee such research and to interface with the RCGM in regulating it.

         Details of the biosafety regulation through Rules 1989 may be viewed at: http://envfor.nic.in/major-initiatives/geac-clearances