This document summarizes India's existing biosafety regulatory framework for genetically modified organisms (GMOs) and gene technologies. It provides an overview of the key agencies and committees that regulate GMOs in India according to the Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/GMOs. It also outlines the process for approving GM crops in India and notes that new gene technologies will be regulated under the existing framework while appropriate guidelines are developed. Currently, GM cotton, brinjal, and mustard have been commercialized or are awaiting approval in India.

1. OECD CONFERNCE ON GENOME EDITING
Applications in Agriculture
Implications for Health, Environment and Regulation
Dr. Murali Krishna Chimata
Scientist-D/ Joint Director
Ministry of Environment, Forest and Climate Change,
Government of India

2. Overview of the Presentation
 Existing Biosafety Regulatory Framework
 Status of GM Crops in India
 Regulation of New Gene Technologies

3. Biosafety Regulations in India
In India all Genetically Modified Organisms (GMOs) including Genetically Engineered
(GE) plants are regulated as per:
“The Rules for the Manufacture, Use, Import, Export and Storage of Hazardous
microorganisms / Genetically engineered organisms or cells (Rules 1989)“ notified under the
Environment (Protection) Act,1986
India is a Party to International Conventions/ Protocols like
 Convention on Biological Diversity
 Cartagena Protocol on Biosafety
 Nagoya Kuala Lumpur Supplementary Protocol on Access and Benefit Sharing and
Liability and Redress

4. Coverage of Rules 1989
The 1989 Rules cover the entire spectrum of activities relating to research, development
and use of Genetically Modified Organisms and their products.
 Manufacture, import and storage of microorganisms and gene technological products
 Genetically engineered organisms/microorganisms and cells and correspondingly to any
substance and products and food stuffs, etc., of which such cells, organisms or tissues
form part
 New gene technologies in addition to cell hybridization and genetic engineering

5. Definitions
As per Rules 1989,
“Gene Technology” means the application of the gene technique called genetic engineering,
include self cloning and deletion as well as cell hybridization;
“Genetic Engineering” means the technique by which heritable material, which does not
usually occur or will not occur naturally in the organism or cell concerned, generated outside
the organism or the cell is inserted into said cell or organism. It shall also mean the formation of
new combinations of genetic material by incorporation of a cell into a host cell, where they
occur naturally (self cloning) as well as modification of an organism or in a cell by deletion and
removal of parts of the heritable material;

6. Implementing Agencies
♦ Ministry of Environment, Forest and Climate Change
♦ Department of Biotechnology, Ministry of Science and Technology
♦ State Governments

7. Statutory Committees
Statutory Committee Function Administrating Agency
Recombinant DNA Advisory Committee
(RDAC)
Advisory Department of Biotechnology
Institutional Biosafety Committee (IBSC) Approval Concerned Institution
Review Committee on Genetic
Manipulation (RCGM)
Approval Department of Biotechnology
Genetic Engineering Appraisal Committee
(GEAC)
Approval Ministry of Environment,
Forest and Climate Change
State Biotechnology Coordination
Committee (SBCC)
Monitoring State Governments
District Level Commitee (DLC) Monitoring State Governments

8. Guidelines and Manuals
Contained Use (DBT)
 Recombinant DNA Safety Guidelines, 1990
 Recombinant DNA Safety Guidelines and Regulations, 1994
 Revised Guidelines for Research in Transgenic Plants, 1998
 Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017
Confined Field Trials (MoEF&CC and DBT)
 Guidelines for Conduct of Confined Field Trials of Regulated GE Plants, 1998
 Standard Operating Procedures (SOPs) for CFTs of Regulated, GE Plants, 2008
 Guidelines for Monitoring of Confined Field Trials of Regulated GE Plants, 2008
Food Safety Assessment (DBT and ICMR)
 Guidelines for the Safety Assessment of Foods Derived from GE Plants, 2008 (updated in 2012)
 Protocols for Food and Feed Safety Assessment of GE Crops, 2008
 Guidelines for Biosimilars, 2012 (updated in 2016)
Environmental Safety Assessment (MoEF&CC and DBT)
 Guidelines for Environmental Risk Assessment (ERA) of GE Plants, 2016
 Risk Analysis Framework, 2016
 ERA of GE Plants: A Guide for Stakeholders, 2016

9.  Drugs and Cosmetic Act,1940
 Seed Act, 1966
 Environmental (Protection) Act, 1986
 Protection of Plant Varieties and Farmers Rights Act, 2001
 The Biological Diversity Act, 2002
 Plant Quarantine Order 2003
 Food Safety and Standards Act, 2006
 Several Other Rules and Sectoral Policies are also applicable for GMOs
Other Relevant Acts

10. Procedure for Approval of GE Crops

11. Definition of GM Food
Food Safety and Standards Act, 2006 provides the Food Safety and Standards Authority of
India to regulate GM foods through the inclusion of “genetically modified or engineered
food or food containing such ingredients” within the definition of food
"genetically engineered or modified food" means food and food ingredients composed of or
containing genetically modified or engineered organisms obtained through modern
biotechnology, or food and food ingredients produced from but not containing genetically
modified or engineered organisms obtained through modern biotechnology;

12.  More than 85 crop species are under various stages of R&D in India
 Rice
 Cotton
 Brinjal
 Chickpea
 Banana
 Ground nut
 Sugarcane
 Crop traits widely under investigation
 Insect resistance
 Drought resistance
 Fungal resistance
Crops and Traits under R&D Pipeline

13. Cotton
Brinjal (Egg Plant)
Mustard
GM Crops Commercialized / Awaiting Approval

14. Public Awareness Initiatives
Hindi Telugu Tamil Kannada
Marathi Punjabi Gujarati Bangla

15. As per the applicable definition of “Gene Technology” and “Genetic Engineering” in
Rules 1989, all new technologies to be regulated as per existing Regulatory
Framework.
However, the subject is still under examination of regulatory agencies and
appropriate Guidelines and SOPs to be drafted.
Regulation of New Gene Technologies

16. More Information
www. geacindia.gov.in

17. Thank You !