Agri revolution or regulatory blind spot? Genome-edited rice crops stir debate

Time of India

09-05-2025

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According to ICAR, genome editing technology (CRISPR-Cas), serves as a precision mutagenesis tool designed to create novel and desirable variants of a native gene(s) found in a living organism.
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Without regulations, consumers can't easily distinguish between gene-edited crops and non-edited ones, say experts.
In 2018, ICAR launched a genome editing research project in rice under the National Agricultural Science Fund.
On May 4, 2025, India made history. The country introduced the first genome-edited rice to the world. At a grand event in the national capital, Union Agriculture Minister Shivraj Singh Chouhan unveiled two new genome-edited rice varieties—DRR Dhan 100 and Pusa DST Rice 1 The Indian Council of Agricultural Research ( ICAR ), the government's apex agriculture research organisation, has developed these innovative varieties; these crops could boost rice yields by up to 30% while also improving drought tolerance and decreasing water use.This is 'a historic milestone' in the field of scientific research. 'These new varieties will play a leading role in heralding the second Green Revolution,' says Chouhan, noting that these new crops will not only enhance production but will also produce beneficial outcomes for the environment by saving water and reducing greenhouse gas emissions.India is the second-largest producer and consumer of rice in the world, behind only China, accounting for nearly 27% of the global production. The country uses nearly 40% of its total arable land for rice cultivation. Thanks to the advanced technologies and farming practices, the country's rice output has grown substantially over the years. In 2023-24, India produced 137 million tonnes of rice, while the projection for 2024-25 suggests a total production of 147 million tonnes.The country's rice output could even swell further in the coming years with the introduction of these new rice varieties. Some experts, however, criticised the development, raising concerns about safety testing. They insist that gene editing should undergo rigorous regulations, even as ICAR asserts that the existing regulations are adequate. There is no need for 'a separate framework for genome-edited crops,' it says.Agriculture Ministry officials indicate that these varieties are expected to take at least four to five years to reach farmers, following completion of the seed development cycle, which includes breeder, foundation, and certified seeds.Given the controversy surrounding genome-edited rice varieties, let's understand the regulatory framework in this regard.According to ICAR, genome editing technology (CRISPR-Cas), serves as a precision mutagenesis tool designed to create novel and desirable variants of a native gene(s) found in a living organism. However, the products made using certain genome editing techniques, such as Site-Directed Nuclease 1 ( SDN-1 ) and Site-Directed Nuclease 2 ( SDN-2 ), are exempt from regulations because of their resemblance to naturally occurring mutations.'In SDN-1 and SDN-2 types of genome editing, a native gene is mutated in its native location to create an alternative form known as an allele, which exhibits a desirable altered expression and function. The mutants created by the SDN-1 and SDN-2 approaches are free of exogenously introduced DNA. These mutants are alike and indistinguishable from spontaneous or induced mutants. Hence, exempted from biosafety regulation of Rules 7-11 of Rules 1989 under Environment (Protection) Act 1986,' ICAR clarifies in a statement.It is important to note that under this regulatory framework for SDN-1 and SDN-2 genome edits, DRR Dhan 100 and Pusa DST Rice 1 received clearance on May 31, 2023, for classification.According to Devinder Sharma, a Mohali-based agriculture expert, corporate influence led to regulatory exemptions for these two varieties. He says, 'The GM industry is promoting genome-edited crops to stay afloat, as they have faced criticism for lacking tangible outputs and are under pressure.'In India, GM crops are subject to regulation; however, there is currently no comprehensive regulatory framework for genome-edited crops, Sharma points out. 'Why can't India have regulation for gene-edited crops, just like the EU?' Sharma enquired.Notably, regulations for genome-edited crops vary across the globe. The EU regulates genetically modified organisms (GMOs), including gene-edited crops, under a stringent framework that mandates rigorous testing, approval, and labelling, while the US and Japan offer some exemptions. Devendra Kumar Yadava , Deputy Director General (Crop Science), ICAR, countered the criticism, asserting that the existing regulatory framework is sufficient and that a separate regulation is not required.'In India, all activities related to genetically engineered organisms (GE organisms) or cells and hazardous microorganisms and products are regulated as per the 'Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells, Rules, 1989' (Rules, 1989) notified by the Government of India under the Environment (Protection) Act, 1986 (EPA 1986). A draft guideline for genome-edited organisms was published by the Department of Biotechnology, Government of India, in 2020 for public consultation. Based on the consultation, scientific results, and inputs from the National Science Academies, the Ministry of Environment, Forest, and Climate Change brought an office memorandum,' says Yadava.'All provisions under Rules, 1989, shall be applicable on genome-edited plants except the rules 7 -11 (both inclusive) on which exemption from regulation has been granted under Rule 20 by the Ministry of Environment, Forests and Climate Change vide Office Memorandum F. No. C -12013/3/2020-CS-III dated 30.03.2022. The GMO regulation rules are applicable to the initial stages of genome editing of plants. The genome-edited plants in later generations are exempted from Rules 7-11 of Rules 1989 once it is proved that the mutant is developed by the SDN-1/SDN-2 approach and it is proved that the mutant does not contain exogenously introduced DNA. As per the 'Standard Operating Procedures (SOPs) for regulatory review of genome-edited plants under SDN-1 and SDN-2 categories, 2022', notified by RCGM, DBT, Govt of India, on October 4, 2022,' explains Yadava.Deepak Pareek, an agriculture economist and convener of the Global Grains and Pulses Council, commended India's genome-edited rice varieties; however,he noted that the widespread adoption of these varieties faced significant challenges. 'A four-to-five-year timeline for commercial rollout underscores the urgency for streamlined regulatory and seed distribution frameworks.''Long-term ecological impacts, particularly on soil and biodiversity across five million hectares, demand rigorous scrutiny, as do intellectual property complexities surrounding CRISPR tools. While water savings and early maturity are compelling, extensive field trials across diverse agroclimatic zones are critical to validate performance,' says Pareek.According to Pareek, the success of these genome-edited rice varieties depends on strategic implementation, farmer-centric education, and ongoing scientific oversight to achieve sustainable outcomes. India is currently implementing gene editing techniques on 24 food crops and 15 horticulture crops, according to government officials. As several new genome-edited varieties are expected to be released in the coming days, experts are urging for a comprehensive guideline specifically for these crops to tackle concerns.Without regulations, consumers can't easily distinguish between gene-edited crops and non-edited ones. This necessitates 'the need for labelling and stricter oversight' for these crops, says Sharma.In a similar vein, The Coalition for a GM-Free India, an advocate for a GM-free world, highlights safety concerns surrounding gene-editing techniques, raising doubts about their safety. 'Gene editing is also genetic modification, as is apparent from the statutory definition in India of genetic engineering. However, the Government of India has deregulated two kinds of SDN-1 and SDN-2, giving specious unscientific rationale. Under a smokescreen of higher yield/drought resistance, etc., it has now released two gene-edited rice varieties without safety testing,' states The Coalition for a GM-Free India in a release, a day after the launch of these crops.'Given the lack of public acceptance of transgenic r-DNA technology—one kind of modern biotechnology—the biotech industry and lobbies have resorted to falsely portraying gene editing as a precise and safe technology, whereas published scientific papers show that this is untrue. India's deregulation of two kinds of gene editing (SDN-1 and SDN-2) is outright illegal,' the Coalition adds.Even Ashok Kumar, Director of Farm Prosperity at Transform Rural India (TRI), hailed the innovation while emphasising the need to conduct thorough biosafety testing of gene-edited and transgenic crops prior to their release for consumption.The 2022 document titled 'The Regulatory Authority for Gene-edited Organisms' issued by the Department of Biotechnology (DBT) states that SDN-1 and SDN-2 are not classified as GMOs. 'But since this is the first time the genome of rice is edited using CRISPR technology, and the product is a staple food, its biosafety for human and animal health must be thoroughly tested and assured before releasing for consumption,' Kumar says.Regarding labelling, Yadava says, 'Genome editing is a precision mutagenesis tool. Mutations are created in the native genes, similar to the conventional mutagenesis approach, and since no foreign gene is presented in the gene-edited crop, labelling is not necessary.'In 2018, ICAR launched a genome editing research project in rice under the National Agricultural Science Fund. The project focused on two popular rice varieties: Samba Mahsuri (BPT5204) and MTU1010 (Cottondora Sannalu), which are cultivated across nine million hectares in the country. The genome-edited rice line, officially designated IET 32072, underwent multi-location field trials in 2023 and 2024 under the All India Coordinated Research Project on Rice (AICRPR) to assess its performance.These varieties promise to increase rice yields by 20-30%. According to ICAR, cultivating these rice varieties on nearly 5 million hectares can yield an additional 4.5 million tonnes of paddy while reducing greenhouse gas emissions by 20% (32,000 tonnes). The shorter duration (reduction by 20 days) of these varieties can also save around 7,500 million cubic metres of irrigation water by reducing three irrigations.However, experts find it confusing to promise unverified yield increases for crops such as rice, considering India's current surplus production. There are also concerns that introducing gene-edited rice varieties could threaten India's rich rice genetic diversity, jeopardise its native rice heritage, and impact trade opportunities for non-GM varieties.While there are concerns, some experts also view this development as a notable step forward, potentially paving the way for further advancements in this field. Ajay Kakra, Leader-Food and Agriculture, GIDAS, Forvis Mazars, India—a global consultancy—states that pioneering genome-edited rice without foreign DNA insertion has the potential to position India as a biotechnology leader. 'However, their long-term credibility hinges on transparent and timely progression through field validation and regulatory processes, he says, noting that the early announcements can increase awareness among stakeholders, enabling them to prepare for adoption.Corteva Agriscience, a global agriculture and seed company, too, welcomed the development but declined to comment on regulatory aspects. 'Gene editing offers a way to grow more food on less land while strengthening crops against pests and climate stressors. Its widespread adoption could redefine how we farm and, more importantly, offer a powerful tool in the global effort to ensure food security,' says the spokesperson of Corteva.Despite the ongoing debate regarding the regulation of genome-edited crops, agri experts like Pareek and Kakra assert that the announcement isn't premature, given its scientific significance and global implications. They suggest ICAR should emphasise the timeline of 4-5 years for seed development and execute rigorous testing and transparency to manage expectations. If concerns are addressed before their commercial launch, these crops hold the potential to redefine farming in the coming days.