In 2020, the Department of Biotechnology published draft guidelines for gene editing regulation that require additional safety and efficacy testing for gene-edited crops. The guidelines continue to be extensively discussed and debated. The guidelines regulate the process used to create gene-edited plants rather than focusing on the characteristics of the final products, as is typically the case in the US and many other countries. A tiered regulatory approval process is proposed, with each tier requiring testing and oversight.
Group I includes plants edited “with one or a few base pair edits or deletions” (sometimes called SDN-1 techniques) and requires confirmation that the gene editing was successful, though the data requirements for confirmation are extensive. Oversight would be done by the research institution’s internal bio-safety committee. Group II includes plants “whose cells harbour a few or several base pair edits” (sometimes called SDN-2 techniques) and require more intensive field trials and data to ensure the edits were successful. It is unclear exactly how distinctions between Group I and Group II plants would be determined or who would make that decision. Group III are plants with large DNA changes, including insertion of foreign DNA (sometimes called SDN-3 techniques) and require the same extensive testing as GMOs, including field trials to test safety to human health, animals, and the environment, with approvals to be obtained from the Institutional Biosafety Committee (IBSC), the Review Committee on Genetic Manipulation (RCGM), and the Genetic Engineering Appraisal Committee (GEAC).
The Genetic Engineering Appraisal Committee (GEAC) is responsible for the approval of genetically engineered crops and products for research, development and cultivation and for processed non-food products. There are currently no defined timelines for regulatory approval of gene-edited products. Prior to commercial approval or importation, current Indian regulations do stipulate that the GEAC must conduct an appraisal of all biotech food and agricultural products, and of products derived from biotech plants and animals.
Food Safety and Standard Authority of India (FSSAI) is responsible for regulating food, but there is an absence of regulations and operational infrastructure for biotechnology products.
Products/Research
- Salt-tolerant rice: National Institute for Plant Biotechnology researchers in New Delhi used CRISPR in 2019 to develop rice able to withstand high concentrations of salt in soil, which reduces rice growth.
- Vitamin A-fortified banana: National Agri-Food Biotechnology Institute researchers used CRISPR in 2018 to biofortify bananas to help address vitamin A deficiency in developing countries.
Regulatory Timeline
2020: Draft guidelines published by the Department of Biotechnology propose tiered regulation where two types of gene editing are highly regulated.
2017: Supreme Court of India issues directives to the Food Safety and Standard Authority of India (FSSAI) to frame regulations that would enable approval of genetically engineered food products.
2016: Genetic Engineering Appraisal Committee (GEAC) accepts new guidelines on environmental risk assessment of genetically engineered plants, which provide a more systematic and structured process, including public consultation for the first time in the approval process.
2013: Department of Consumer Affairs (DCA) stipulates all genetically modified food shall be labeled “GM,” but there has been no enforcement of the labeling requirement.
2008: GEAC adopts Guidelines and Standard Operating Procedures for the Conduct of Confined Field Trials and Guidelines for Safety Assessment of Foods derived from Genetically Engineered Plants.
2006: Food Safety and Standards Act of 2006 enacted, which regulates genetically engineered food products and processed foods.
2003: Cartagena Protocol (an international agreement) ratified, which protects the transport and use of organisms modified by biotechnology.
1990: Recombinant DNA Guidelines developed.
1989: Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells, 1989, known as the Rules, 1989, finalized, which regulate research, development, large-scale use and import of genetically engineered organisms and products.
NGO Reaction
Environmental and consumer groups, often supported by Greenpeace, campaign against genetically engineered organisms and products, and have been influential in blocking the introduction of biotechnology, arguing that “GE crops harm the environment” and pose risks to human health. The most aggressive critic is Vandana Shiva, an India-born global anti-biotechnology activist, who maintains that the Green Revolution caused more problems than it solved and that biotechnology is a form of corporate colonialism. She opposes even the testing of biotechnology crops and actively promotes direct action campaigns, including eco-terrorism to destroy field trials and research. Seed and agricultural technology companies formed an association in 2018, Alliance for Agri-Innovation (AAI), to promote agricultural biotechnologies and other plant breeding innovations.
Additional Resources
- Genes and Science’s FAQ on gene editing
- USDA Agricultural Biotechnology Annual: India
