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India: Crops / Food

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Lightly Regulated

Gene-edited crops without ‘foreign genes’ are exempted from restrictive regulations in place for transgenic (GMO) crops, opening the door to field trials leading to commercial release

Although no gene-edited crops have yet been commercially released under newly-relaxed regulations, numerous crops are in development and could be approved for market in the years ahead. Indian public sector research laboratories are developing, among other crops, rice and maize that can tolerate drought stress; beta carotene-rich banana; high oleic and low linoleic acid ground nuts, blast-resistant rice; nitrogen and water-use efficient high-yield rice; anthracnose-resistant pepper; biotic stress-tolerant tomato; nutritionally-improved oil seeds; and disease-resistant, anole-quality, low-glucosinolate mustard lines.

Traditionally, all genetically modified crops in development in India have been regulated by the process by which the product was developed (as has been the case in the EU) rather than by the final product itself (as in the US, Canada, Brazil and numerous other countries). These so-called GMOs involved ‘transgenesis’ — the introduction of genes from other organisms to confer specific traits, such as resistance to pests, tolerance to herbicides, improved nutritional content, or longer shelf life. Known as “The Rules, 1989,” these regulations, enacted as a result of India considering GE crops as GMOs, were based on guidelines concerning contained research, biologics, and environmental and food system risks. Insect-resistant Bt cotton, approved for in 2002, is the only GMO crop currently allowed for cultivation 

In what the Indian government called a “landmark decision”, in March 2022, the Union Ministry of Environment and Forest revised those regulations, allowing field trials of crops developed “free of exogenous introduced DNA” (derived by processes known as SDN-1 and SDN-2) for open field trials leading to commercial release. Both techniques involve “knocking off” or “overexpressing” certain traits within a gene without introducing new genetic material. Products derived through SDN-3, which involves the introduction of foreign genes, are still considered as GMOs.

The Institutional Bio-Safety Committee (IBSC), comprising scientists from the institutions engaged in the GE crop development and from the Department of Biotechnology, still needs to certify that a gene-edited crop is devoid of any foreign DNA, presenting as yet unknown challenges for commercial release.

Products/Research

  • Pest and disease resistant mustard, 2023: Scientists at the Delhi University’s Centre for Genetic Manipulation of Crop Plants (CGMCP) and the Indian Council of Agricultural Research used CRISPR-Cas9 to develop a less pungent mustard with significantly higher glucosinolate. Field testing is set to begin in 2024.
  • Drought resistant rice, 2022: Expected to be commercially available by 2026, the gene-edited drought-resistant rice was developed at the Indian Agricultural Research Institute.
  • Salt-tolerant rice, 2019: National Institute for Plant Biotechnology researchers used CRISPR to develop rice able to withstand high concentrations of salt in soil.
  • Vitamin A-fortified banana, 2018: National Agri-Food Biotechnology Institute researchers used CRISPR to biofortify bananas to help address vitamin A deficiency in developing countries.

Regulatory Timeline

2022: Ministry of Environment, Forest and Climate Change announces the exemption of genome-edited plants without foreign genes from being regulated as transgenic products, paving the way for field trials and eventual commercialization of GE crops.

2020: Draft guidelines published by the Department of Biotechnology propose tiered regulations in which crops grown without ‘foreign genes’ do not require pre-approval for test trials.

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. 

Vandana Shiva, an India-born global anti-biotechnology activist, is the most aggressive critic of all forms of genetic engineering. She 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. 

Kavitha Kuruganti of the Alliance for Sustainable and Holistic Agriculture called the 2022 deregulation, “unscientific and risky. Genome editing as per Environmental Protection Act 1989 rules has to be regulated fully by GEAC and not selectively,”

Prof. Pushpa M. Bhargava, of the Indian Centre for Cellular and Molecular Biology and the National Knowledge Commission warned: “The ultimate goal of this attempt in India of which the leader is Monsanto is to obtain control over Indian agriculture and thus food production. With 60 percent of our population engaged in agriculture and living in villages, this would essentially mean not only control over our food security but also over our farmer security, agricultural security, and security of the rural sector.” 

Additional Resources

  • USDA Agricultural Biotechnology Annual, 2022: India

Updated: 09/03/2023 

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which agriculture products and processes are approved or in development and their regulatory status. The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs.

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Agriculture Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
Lightly Regulated: Some or all types of gene editing are regulated more strictly than conventional agriculture, but not as strictly as transgenic GMOs.
*Determined: No Unique Regulations: Gene-edited crops that do not incorporate DNA from another species are regulated as conventional plants with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene-edited crops that do not incorporate DNA from another species would no require unique regulations beyond current what is imposed on conventional breeding.

Crops/Food:
Gene editing of plants and food products. Research and development has mostly focused on disease resistance, drought resistance, and increasing yield, but more recent advances have produced low trans-fat oils and high-fiber grains.
Animals:
Gene editing of animals, not including animal research for human drugs and therapies. Fewer gene edited animals have been developed than gene edited crops, but scientists have developed hornless and heat-tolerant cattle and fast-growing tilapia may soon be the first gene edited animal to be consumed.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / RegionFood / CropsAnimalsAg Rating
Ecuador101010
Norway666
Africa555
Japan888
Brazil101010
Canada888
Russia555
Argentina101010
Israel1057.5
Australia888
Switzerland555
China555
US1047
Chile1015.5
New Zealand444
Ukraine111
Central America666
Paraguay101010
Uruguay666
India666
UK222
Mexico111
EU222
Colombia1015.5

Global gene editing regulatory landscape

The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs. Regulations across 34 countries where transgenic or gene edited crops and animals are commercially allowed (as of 12/19) are guided in part by two factors:
 
 
Whether the country has ratified the international agreement that took effect in 2003 that aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from biotechnology that may impact biological diversity, also taking into account potential risks to human health. It entered into force for those nations that signed it in 2003. It applies the ‘precautionary approach as contained in the Rio Declaration on Environment and Development. The US, Canada, Australia and Chile and the Russian Federation have not signed the treaty.
 
 
Whether regulations are based on the genetic process used to create the trait (conventional, mutagenesis, transgenesis, gene editing, etc.) or the final product.Transgenic crops and animals (aka GMOs) are product regulated in many countries including the US and Canada, while the EU, India, China and others regulate based on how the product is made. There is almost an equal number of countries with product- and process-based regulations. It’s not clear how much this distinction matters. It’s somewhat true that countries with product-based regulation have more crops approved and the approval process is more streamlined, but there are contradictions. For example, Brazil and Argentina have emerged as GMO super powers using different regulatory concepts, while there is no GMO commercial cultivation in Japan, North Korea, and the Russian Federation, which employ product-based regulations. How this will effect gene editing regulations is also unclear. For example, Japan, which has no commercialized GMOs, is emerging as a leader in the introduction of gene edited crops.
Agricultural Landscape
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Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.