FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA, 3RD FLOOR, FDA BHAWAN, KOTLA ROAD.
A. Biosafety Regulations in India
1. All genetically modified organism and products thereof are regulated in India. The Ministry of Environment & Forests has notified the “Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro Organisms/ Genetically Engineered Organisms or Cells through Notification No. 621 in Official Gazette of Govt. of India on December 5, 1989 under the provisions of the EPA with a view to ensure sound application of biotechnology making it possible to accrue benefits arising from modern biotechnology while minimizing the risks to environment and human health.
2. These rules and regulations 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.
3. Rules 1989 is 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).
- 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.
- Guidelines on Similar Biologics: Regulatory Requirement for Market Authorization
- Guidelines and Handbook for Institutional Biosafety Committees
4. Rules 1989 is implemented by MoEF, Department of Biotechnology (DBT), Ministry of Science and Technology. MoEF is primarily responsible for conservation and protection of environment, ensuring environmental and human health safety before release of genetically modified organisms (GMOs) and products thereof. 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 competent authorities. 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 DBT 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 MoEF 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 is established under the institution engaged in GMO research to oversee such research and to interface with the RCGM in regulating it.
5. The GEAC is following a policy of case by case event based approval in case of Genetically Modified (GM) foods or food crops. In view of the various concerns, introduction of any new GM food /food crop is preceded by a careful analysis of risks and evaluation of long term benefits for which extensive rules and guidelines have been framed by the GEAC/RCGM for evaluating environmental and health safety impacts of genetically modified organisms.
Structure for GM food safety assessment:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Ministry of Environment & Forests, Indira Paryavaran Bhawan, Jor Bagh, New Delhi -110 003.
GM food safety assessment guidelines:
Conduct of GM food safety assessment:
Supplemental information on the implementation:
Regulation of stacked events:
Supplemental information on the stacked events:
Production and trade
GM food/feed production:
GM food/feed imports:
Supplemental information on the production and trade:
Supplemental information on the LLP/AP incidents:
Supplemental information on the Labelling requirement:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment