The Government of India is facing sharp criticism from civil society and scientific groups following the release of two gene-edited rice varieties — Kamala (DRR Dhan 100) and Pusa DST Rice 1 — developed using CRISPR/Cas9-based SDN-1 genome editing. The Coalition for a GM-Free India has called the move "illegal, unscientific and irresponsible," and demanded the immediate withdrawal of the varieties, citing serious health, environmental, legal, and ethical concerns.
In a strongly worded press statement, the Coalition accused the Union Government of bypassing statutory biosafety regulations and acting under pressure from corporate biotech lobbies. It warned that the gene-edited rice varieties, released on May 4, 2025, could pose irreversible risks to consumer health and the environment, while undermining India’s seed sovereignty.
The controversy arises from a 2022 government notification that exempted SDN-1 and SDN-2 gene-editing techniques from the scope of existing GM regulatory oversight. The Coalition asserts that this deregulation directly violates the Environment Protection Act (EPA) of 1986 and its 1989 Rules. Citing Rule 3(iii) and 3(iv), the Coalition emphasized that gene editing — including deletions and insertions via genome editing tools — is clearly covered under the legal definition of genetic engineering and gene technology in India. “It is unlawful to release genetically engineered material without rigorous testing. Gene editing is genetic modification. The government’s 2022 exemptions are not only flawed in logic but illegal in spirit and letter of law,” the Coalition stated.
The group pointed to a growing body of international scientific research indicating that gene editing, including SDN-1 technologies, is imprecise and can result in unintended mutations. These unintended genetic alterations could lead to the development of novel proteins, possibly toxic or allergenic, with unpredictable consequences for human health and the environment. Studies such as those by Chu P. et al. (2022) and Sukumar Biswas et al. (2020) highlight the risks of large genetic rearrangements and the failure of conventional screening methods to detect such changes. These risks, the Coalition noted, are exacerbated by the lack of mandatory long-read sequencing or multi-generational analysis in India’s current regulatory framework.
In gene-edited rice using SDN-1 techniques, the potential for unintended integration of foreign DNA or vector fragments into the host genome remains high. According to the Coalition, this makes deregulated gene editing potentially as risky as transgenic GMOs. They also cited instances in genome-edited cattle, mice, and plants where foreign vector DNA, antibiotic resistance genes, and even animal DNA from culture media had inadvertently been inserted into the genome. This poses the risk of horizontal gene transfer and genetic contamination, which can compromise biosafety and biodiversity.
India, being a global Centre of Origin and Diversity for rice, has much to lose, the Coalition argued. It expressed concern that the introduction of genome-edited rice threatens the country's rich indigenous gene pool and could lead to irreversible genetic contamination of native varieties. Further, the release of these gene-edited crops could compromise farmers’ rights and seed sovereignty due to the intellectual property rights associated with the underlying technologies. According to the Coalition, these gene-editing tools are already under patent protection, which opens the door to corporate control over Indian agriculture. The claimed benefits of improved yield or drought tolerance are unproven and do not justify the introduction of risky, inadequately regulated technologies, especially in a country with surplus rice production.
The group further alleged that the release of gene-edited crops without rigorous biosafety testing and public consultation violates the July 2024 Supreme Court order mandating such procedures for all genetically engineered organisms. They called this act a potential contempt of court.
The Coalition demanded that the Government of India immediately withdraw Kamala and Pusa DST Rice 1 from public release, revoke the 2022 exemptions that deregulate SDN-1 and SDN-2 gene editing techniques, and publicly disclose the safety testing protocols, development history, and intellectual property details of these varieties. They emphasized the need for all genome-edited crops to be subjected to independent biosafety assessments, environmental risk evaluations, and widespread public consultation. The group also stressed the urgent need to protect native germplasm and uphold India’s food and seed sovereignty.
In conclusion, the Coalition stated that given the unpredictable nature of gene-editing outcomes and the absence of transparency, India must adopt the precautionary principle and subject gene editing to the same level of regulation and scrutiny as conventional GMOs.
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*Freelance writer
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