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Regulatory aspects associated to genome editing in India

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This presentation highlights the existing Biosafety regulatory framework, the status of GM crops and the regulation of new gene technologies in India.

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Regulatory aspects associated to genome editing in India

  1. 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. 2. Overview of the Presentation  Existing Biosafety Regulatory Framework  Status of GM Crops in India  Regulation of New Gene Technologies
  3. 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. 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. 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. 6. Implementing Agencies ♦ Ministry of Environment, Forest and Climate Change ♦ Department of Biotechnology, Ministry of Science and Technology ♦ State Governments
  7. 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. 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. 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. 10. Procedure for Approval of GE Crops
  11. 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. 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. 13. Cotton Brinjal (Egg Plant) Mustard GM Crops Commercialized / Awaiting Approval
  14. 14. Public Awareness Initiatives Hindi Telugu Tamil Kannada Marathi Punjabi Gujarati Bangla
  15. 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. 16. More Information www.
  17. 17. Thank You !