The Indian Council of Agricultural Research’s launch of two climate-resilient, gene-edited rice varieties marks a scientific breakthrough for sustainable agriculture, but it also reignites debates over biosafety, ethics, regulation, and farmer access.
In a notable milestone for India’s agri-biotechnology sector, the Indian Council of Agricultural Research (ICAR) announced the development of two gene-edited rice varieties that display climate resilience and enhanced productivity, achieved without any introduction of foreign DNA. Despite marking a tremendous step towards sustainable agriculture and food security, the release sparked public debate over biosafety, ethics, and consumer acceptance, necessitating a nuanced assessment of gene-edited food crops in the Indian context.
India is the largest producer of rice globally and relies on rice for its food and nutritional security. Rice cultivation, however, is hampered by low yield, drought, and soil salinity, which are ubiquitous in Indian farming regions, but exacerbated by climate change. States in the Indo-Gangetic Plains, which contribute to over 50 percent of India’s agricultural production, face unpredictable rainfall patterns and drought conditions, damaging agricultural output. Reduced rice production led India to curb its rice exports in 2022 and 2023 and renewed calls to develop resilient varieties of rice, wheat, and millets for long-term sustainability.
Japan’s Sanatech Seed’s GABA-enriched tomato (GABA or γ-aminobutyric acid is a neurotransmitter that has health-promoting effects), which lowers blood pressure, was the first CRISPR-edited foodstuff to enter the market.
Conventional breeding is time-consuming, while genetically modified (GM) techniques are subject to intense regulatory and safety scrutiny. In contrast, gene-editing (GE) technologies enable an accelerated, precise, and affordable method for plant breeders. Several GE crops are in laboratory studies, field trials, or are approved for commercial cultivation globally. Japan’s Sanatech Seed’s GABA-enriched tomato (GABA or γ-aminobutyric acid is a neurotransmitter that has health-promoting effects), which lowers blood pressure, was the first CRISPR-edited foodstuff to enter the market. Bayer, along with South Korean biotech company G+FLAS, is working on producing Vitamin D3-fortified tomatoes to address Vitamin D deficiency, while Corteva is developing waxy corn for the food manufacturing industry.
The development of two GE rice varieties - RR Rice 100 (Kamala) and Pusa DST Rice 1 – was announced by ICAR in May 2025. Using a CRISPR/Cas9 gene-editing platform, scientists carried out precise gene edits through Site-Directed Nuclease-1 (SDN-1), enhancing yield and improving adaptation to salt, drought, and climate stressors. In contrast to GM crops, gene editing does not involve the introduction of foreign DNA but instead targets small changes in an organism’s own DNA.
The DRR Rice 100 (Kamala) variety, developed by ICAR-IIRR, is based on the popular Samba Mahsuri (BPT 5204). Gene-editing of cytokinin oxidase (OsCKX2), an enzyme that regulates plant growth, resulted in a variety that displays greater yield, early maturity, and reduced reliance on fertilisers. The Pusa DST Rice 1 variety, developed by ICAR-IARI, is based on MTU1010 and was engineered by knocking out the gene (DST) responsible for suppressing stress resistance. The edited crop displays salt and drought tolerance, with yield potentially increasing up to 20 percent. Researchers are already investigating the application of gene-editing technologies in other crops, including wheat, pulses, oilseeds, cotton, tobacco, tomato, banana, and tea.
In contrast to GM crops, gene editing does not involve the introduction of foreign DNA but instead targets small changes in an organism’s own DNA.
The development of GE rice varieties in India is a significant stride in closing the gap between innovation and policy. However, the announcement sparked public debate and protest with concerns over biosafety, ethics, farmer access, and intellectual property rights (IPR). For these crops to be adopted and accepted by consumers, policies must address the issues that have complicated India’s experience with GMOs to garner public trust.
Much of the scepticism stems from India’s experience with GM crops. Since the release of Bt cotton in 2002, India’s agri-biotechnology sector has been marred by controversy and policy uncertainty. Despite the widespread cultivation of Bt cotton, the moratorium on Bt brinjal in 2010, delays in the commercial cultivation of GM mustard, and the absence of a comprehensive national GM crop policy have created public mistrust. Dwindling private sector investment, reduced public sector momentum, and farmers - especially smallholders - being left to face climate and pest infestation volatilities without access to the latest technologies have further deepened this mistrust.
Globally, the regulatory landscape of gene-editing technologies in agriculture is highly fragmented. Countries such as the United States (US), Canada, Japan, Australia, Chile, Brazil, Kenya, and Ecuador place crops modified through SDN-1 and SDN-2 outside the ambit of stringent GM regulations. This is because, molecularly, the gene edits that occur by SDN-1 and SDN-2 are indistinguishable from changes that would occur naturally or through conventional mutagenesis. Japan, a pioneer of GE food products, follows a similar framework but allows GE foods to be sold to consumers without any safety or environmental testing.
Countries such as the United States (US), Canada, Japan, Australia, Chile, Brazil, Kenya, and Ecuador place crops modified through SDN-1 and SDN-2 outside the ambit of stringent GM regulations.
Recognising the potential of gene-editing, India’s Department of Biotechnology (DBT) issued guidelines in 2022 that distinguish SDN-1 and SDN-2 edits from GMOs, placing them on an accelerated regulatory pathway. Further, GE-crops developed using SDN-1 and SDN-2 are exempted from the stringent GM approval process put in place by the Food Safety and Standards Authority of India (FSSAI). Thus, India’s GE rice varieties will now undergo extensive trials for multiple seasons across the country and will eventually be commercialised. In contrast, the European Union (EU), South Africa, and New Zealand continue to place GM and GE crops under strict GMO rules. However, this stance may change, with intense momentum in Europe and in New Zealand to reduce the regulatory oversight over GE crops, potentially enabling fast-tracked cultivation.
Fragmented global regulatory guidelines on GE crops impede global trade, innovation, and competitiveness. While India permits only the cultivation of Bt-cotton and strict regulations do not permit the import of GMOs, the imports of GM soyabean and maize were central to India’s ongoing trade spat with the US. This illustrates how agri-biotechnology regulations shape global trade, signalling that GE crops may soon be part of trade negotiations. Beyond India, China is heavily invested in adopting GE tools for food security and recently adopted new regulatory guidelines for GE crops, while the UK, in June 2025, introduced legislation permitting the release and marketing of GE crops.
There exists an urgent need for a comprehensive and transparent regulatory policy on GE crops in India. Political polarisation and weak science communication fuel public mistrust, often framing agri-biotechnology as a threat rather than an opportunity. For GE crops to achieve their full potential, stakeholders, including scientists, government regulators, farmers, civil society, intellectual property rights (IPR) experts, and academia, must responsibly communicate the science and regulatory aspects of GE crops. Transparency in risk assessment data, field trial results, and biosafety considerations must be ensured to minimise the scope for misinformation. Public trust in biotechnology governance must simultaneously be fostered, and consumer awareness must be raised.
Farmer unions and civil society organisations have voiced concerns that GE crops may out-compete native species, reduce biodiversity, or cause other ecological damage. Risk assessment measures would need to consider reproductive capacity, spread, and impact on native species and insects. Post-market environmental monitoring will also need to be conducted to assess long-term impacts.
Computational tools that minimise the likelihood of off-targets are increasingly being developed, while established breeding and selection practices ensure off-target plants are eliminated.
With regard to food safety, gene-edited crops are considered to pose fewer safety risks compared to GMOs. However, off-targets or unintended edits made on a genome remain a challenge and necessitate detailed molecular characterisation and screening over multiple generations before commercial release. Computational tools that minimise the likelihood of off-targets are increasingly being developed, while established breeding and selection practices ensure off-target plants are eliminated. Further, analyses should also incorporate the post-harvest phase, as food processing, such as high-temperature cooking, could have unintended effects.
Intellectual Property Rights (IPR) will be another decisive factor in shaping the accessibility of GE food crops. Globally, the approach to patents varies. The US and Japan have broad patent protections, while the EU is considering banning patents for GE crops as a means to ensure seed sovereignty or the collective right of farming communities to control their seeds.
Further, the original innovators of CRISPR are embroiled in a patent dispute, and this has kept licensing costly and fragmented. In India, the Patent Office granted rights to ERS Genomics in 2022 for research-use only. Commercial deployment will require separate and expensive permissions, making the translation of GE crops into farm-ready crops uncertain. The challenge for India will be to balance a patent-centric approach that could attract research and development (R&D) with one that supports its Protection of Plant Varieties and Farmers’ Rights framework (PPVFR), which gives primacy to accessibility. For Indian smallholder farmers, if high licensing costs are passed down the seed value chain, then farmers may be excluded, and a scenario where farmers bear the costs of the new technologies but do not reap the benefits may arise. Equitable benefits can be ensured through mechanisms such as pooled licensing, compulsory licensing, or investments in developing indigenous CRISPR platforms.
Rapid advances in GE technologies offer tremendous scope to address the unabating need for resilient food crops to adapt to changing climate realities. The recently adopted framework, issued by DBT in 2022, distinguishing SDN-1 and SND-2 edits from GMOs, enables a faster approval route for GE food crops. Thus, India’s gene-edited rice varieties signify the convergence of scientific innovation with policy. Establishing concrete guidelines for GE crops that incorporate advanced computational techniques to address safety risks and post-harvest analyses aligns with global advances in IPR. This can also ensure that responsible science communication will foster an environment where scientific advances, ecological stewardship, and food security coexist.
Lakshmy Ramakrishnan is an Associate Fellow with the Health Initiative at the Observer Research Foundation.
The views expressed above belong to the author(s). ORF research and analyses now available on Telegram! Click here to access our curated content — blogs, longforms and interviews.
Lakshmy is an Associate Fellow with ORF’s Centre for New Economic Diplomacy. Her work focuses on the intersection of biotechnology, health, and international relations, with a ...
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