Govt of India’s release of Gene-Edited GM rice varieties illegal –
Govt knows that lack of safety will reveal itself if the GEd rice varieties are put through regulatory testing and therefore de-regulated SDN-1 and SDN-2 gene editing techniques in India
Coalition for a GM-Free India demands that Govt of India immediately withdraw the two released and untested gene edited rice varieties (Kamala and Pusa DST Rice 1) and bring gene editing under the purview of rigorous regulation
The two genome-edited rice varieties have the potential to harm humans and cause irreversible damage to the environment, in addition to threatening our seed sovereignty
Precautionary Approach need of the hour
New Delhi, May 5th 2025: The Coalition for a GM-Free India accused the Government of India of being devious, unscientific and irresponsible in releasing two genome-edited rice varieties on Sunday, May 4th 2025. “It is shocking that the Government of India is doing unlawful things under pressure from corporate lobbies. There is an enormous body of scientific literature that is pointing to the lack of safety of gene editing techniques. Gene Editing is also genetic modification as is apparent from the statutory definition in India of Genetic Engineering. However, Government of India de-regulated two kinds of SDN-1 and SDN-2 giving specious unscientific rationale, and under a smokescreen of higher yield/drought resistance etc., has now released two gene edited rice varieties without any safety testing at all. We object to it and warn the government that strong resistance will be put up against this development. Public spirited scientists and concerned citizens will join hands like in the past to expose the irresponsible and unscientific approach of the government”, stated the Coalition in a press statement.
“Given the lack of public acceptance of transgenic r-DNA technology which is 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 de-regulation of two kinds of gene editing is outright illegal. Environment Protection Act 1986’s relevant statutory Rules (1989 Rules which have been created with a view to protect environment, nature and health in connection with the application of gene technology) clearly define Gene Technology as “the application of the gene technique called genetic engineering, including self-cloning and deletion as well as cell hybridisation” (Rule 3(iii)) while Genetic Engineering is defined as “the technique by which heritable material, which does not usually occur or will not occur naturally in the organism or cell concerned, generated outside the organism or the cell is inserted into said cell or organism. It shall also mean the formation of new combinations of genetic material by incorporation of a cell into a host cell, where they occur naturally (self cloning) as well as modification of an organism or in a cell by deletion and removal of parts of the heritable material” (Rule 3(iv)). Gene Editing of ALL kinds is clearly covered in these definitions and the very act of de-regulating as done through Union Government’s 2022 exemptions is outright illegal”, pointed out the Coalition.
Moreover, gene editing tools are proprietary technologies under IPR ownership and have a direct bearing on seed sovereignty of India’s farming community, in addition to being a wastage of public resources. “The Government of India has to reveal the situation with regard to IPRs on the released varieties transparently, immediately. The Government of India is compromising on farmers’ seed sovereignty and our food sovereignty by bringing in technologies entangled in IPR issues. Promising some unverified yield increases on cereal crops like rice on which India already has a surplus production, the monoculture of which is causing severe environmental problems, cannot be the rationale for introducing a risky crop in India’s food systems”, said the Coalition.
There is enough scientific evidence (details in links given below) to suggest that gene editing technology is not precise and causes unpredictable genetic errors both at the targeted site and off-site. Although, the agricultural biotech industry and its allies claim that gene-editing tools such as CRISPR/Cas bring changes in the genome in a precise and controlled way, leading to specific intended changes and nothing else, there is a large and ever-growing number of scientific evidence showing that gene editing is not precise but gives rise to numerous genetic changes, also known as unintended mutations. These unintended mutations in SDN-1 technology, used in the two gene edited rice varieties that were released in May 2025, can lead to the creation of new gene sequences producing new mutant proteins, with unknown consequences to the health of consumers, and to the environment. These alterations can lead to compositional changes, which, scientists warn, could prove to be toxic and/or allergenic to human or animal consumers.
It is also important to note that de-regulated techniques of SDN-1 and SDN-2 gene editing also involve foreign genetic material being used and unintentionally implanted in the host organism (reference in below links). Since SDN-1 and SDN-2 gene editing has been de-regulated, there is no biosafety testing mandated at the moment in India to even check for the inclusion of such foreign genetic material.
Evidence points to the fact that gene editing causes genetic changes that are different from those that happen in nature and their consequences are poorly understood. Chu P et al., in their 2022 paper show that identifying certain larger DNA damages could only be possible using long-read sequencing, which is generally not performed. For this and other reasons mentioned in the paper, Chu P et al. point out that the occurrence of unintended DNA damages is underestimated in the literature.
Sukumar Biswas et al. in their paper published in May 2020 conclude that SDN-1 technology, using CRISPR/Cas9 system is imprecise in rice, and that early and accurate molecular characterization and screening must be carried out for many generations before transitioning of the CRISPR/Cas9 system from laboratory to field. In many cases they found large insertions, deletions, and rearrangements of DNA, raising the possibility that the function of genes other than the one targeted could have been altered.
In the face of such strong evidence, it is premature to release the two gene edited varieties of rice Kamala (DRR Dhan 100), developed by the Indian Institute of Rice Research (ICAR-IIRR), Hyderabad, and Pusa DST Rice 1, developed by the Indian Agricultural Research Institute (IARI), Delhi. They have been developed using SDN-1 technology, using CRISPR/Cas9 system, the exact same technology that Sukumar et al., show is imprecise for rice.
In the past, the Coalition had already written (here and here) to various Government authorities and departments pointing out the dangers of de-regulating gene-editing technologies, pointing out the irreversible risks associated with it. The Coalition had also given detailed feedback on strengthening the regulation for gene-edited crops in India.
Moreover, these two gene-edited rice varieties put India at risk of losing its diverse gene pool with respect to rice. India is a Centre of Origin and Diversity for rice, and it becomes imperative that India protects our rice diversity. Maintaining a diverse gene pool becomes even more important with the rapid changes in climate.
“Release of these varieties not only jeopardises our native diversity of rice varieties, but also threatens our trade possibilities in non-GM varieties”, said the Coalition.
“We demand that the Government of India should immediately share details of the safety testing done on these varieties of gene-edited crops, and show/ prove that public interest and native germplasm did not get irresponsibly, irretrievably compromised. There is a lack of public information on the exact process undertaken to develop these two varieties of gene-edited rice. These crops should not be released without sufficient independent testing and must be subject to public scrutiny. It is clear that what has been done here is violative of the Supreme Court’s orders of July 2024 and tantamount to contempt of court. Government should stop any such release and stop compromising on farmer livelihoods, consumer health, and environmental sustainability”, the Coalition demanded.
Additional Notes and materials:
1. SDN1 is supposed to involve gene deletion or disruption, while SDN2 is supposed to involve gene alteration using a DNA repair template. The riskiness in these techniques is not just about the introduction of foreign genes or not. It is about small intended changes using gene editing techniques resulting in large and unintended consequences that can include toxicity or allergenicity of gene-edited plants. Complex unpredictable changes can result even from SDN1 and SDN2. In 2022, exemptions for regulation of SDN-1 and SDN-2 from GM regulations (which means de-regulation of SDN-1 and SDN-2) were announced by the Government of India. It is therefore not just about the risk of the end product, but the risks of the applied gene technological procedures that result in intended and unintended changes. SDN1 can end up accidentally introducing whole foreign plasmids or fragments thereof, if the gene editing tool is introduced as plasmids. SDN1, therefore, can potentially be an unplanned or unexpected transgenic GMO. In SDN2 too, there is a high probability of the repair template DNA getting incorporated into the host genome. This would mean that in addition to the intended repair, the repair template DNA can get integrated at the edit site or off-target location. Therefore, accidental process-induced introduction of superfluous and/or foreign DNA is found both in GE organisms as well as in GEd organisms. This can be detected only when tested. Such testing does not happen with de-regulation!
For example: Genome edited cattle – modified to have no horns – were found to have about 4000 kbp of superfluous DNA present originating from the bacterial plasmid vector, including two antibiotic resistance genes. This was not established by the producer of the cattle, but by researchers in the regulatory agency FDA. Norris et al. 2020, Nature Biotechnology 38, pages 163–164(2020), doi: 10.1038/s41587-019-0394-6
Other cases of unintended integration of non-host DNA include: mice (e.g. Ono et al., 2015 and Ono et al. 2019); Plants (e.g. Jacobs et al., 2015, Li et al., 2015); fish (Gutierrez-Triana et al., 2018); fruitflies (Drosophila melanogaster), nematodes (C. elegans), yeast and other fungi (eg Aspergillus); and planktonic crustaceans (Daphnia magna).
Whilst the insertion of vector DNA into DNA double-strand breaks is in itself a matter of concern, it is of perhaps even greater concern, that any other trace DNA present in the culture medium may be inserted into the host DNA. Ono et al., 2019, for example, identified the presence of goat DNA and bovine DNA in the genome of the genome-edited mice. This depended on whether goat or foetal calf serum had been used as a culture medium in the experiments. In fact, even retrotransposons had been transferred. In this context it becomes obvious that genome editing may unintentionally become a mechanism for horizontal gene transfer of not only foreign DNA but pathogens alike.
In a recent paper on CRISPR-cas9-mediated HDR (Skryabin et al. 2020; Science Advances doi: 10.1126/sciadv.aax2941) authors reported not just about the unintended insertion phenomena (both for NHEJ & HDR) but also the difficulty of detecting these. The authors state in their abstract: “Nevertheless, the rapidly evolving technique still contains pitfalls. During the generation of six different conditional knockout mouse models, we discovered that frequently (sometimes solely) homology-directed repair and/or non-homologous end joining mechanisms caused multiple unwanted head-to-tail insertions of donor DNA templates. Disturbingly, conventionally applied PCR analysis, in most cases, failed to identify these multiple integration events, which led to a high rate of falsely claimed precisely edited alleles. We caution that comprehensive analysis of modified alleles is essential and offer practical solutions to correctly identify precisely edited chromosomes.”