India should establish an independent biosafety institute to assess merits of farm products developed through modern biotechnology

Widespread enthusiasm has been witnessed in the media over the unveiling of India’s first gene-edited rice varieties — DRR Dhan 100 (Kamala) and Pusa Rice DST1.

These varieties, developed by two laboratories of the Indian Council of Agricultural Research (ICAR), are claimed to be high-yielding, drought- and salinity-tolerant, and to require low doses of fertilisers and water. Additionally, they emit less methane compared to other cultivated rice varieties. It is further claimed that these varieties are non-transgenic, as no foreign DNA was introduced in the application of the CRISPR-Cas genome-editing technique.

However, the Environmental Ministry’s exclusion of gene-edited crops from various regulatory checks, which apply to GM crops under the Department of Biotechnology (DBT) and other Union Environment agencies (as of April 2022), raises several questions.

The CRISPR-Cas technology, the core of gene editing, is patented and monopolised by American and other multinational firms. This raises serious concerns about potential monopolies over gene-edited rice seeds, their cost, and access for small farmers in India.

Satendra Kumar Mangrauthia, the head of the team that developed DRR Dhan 100, attributed the higher yields to the editing of a novel allele of a cytokinin oxidase/dehydrogenase gene using the gene-editing technique. The metabolic change has led to significantly higher grain numbers per panicle, resulting in greater overall yields.

Furthermore, field trials conducted across multiple agro-ecological zones, he claims, showed a 19 per cent yield increase over the popular variety, Samba Mahsuri, alongside earlier maturity.

However, the developers have not disclosed specific technical details about the genes altered, the procedures followed, or the data from field trials (e.g., volumes of irrigation water, nitrogen/phosphorus doses, pest and disease scores). Also not revealed are the environmental and biosafety standards adhered to during the development of the new rice varieties.

The big picture

The Site-Directed Nucleases (SDN1 and SDN2) employed in CRISPR technology to insert or knock out (delete) specific genes are mutagenic in nature.

The dosages of the CRISPR-Cas9 enzyme, along with unintended effects from residual enzyme left in the plant genome, are yet to be fully understood. Both ICAR laboratories, IIRR in Hyderabad and IARI in Delhi, have not shared their technical data publicly nor published it in peer-reviewed journals.

Plant biotechnology goes beyond GM or gene editing and encompasses many other beneficial core technologies, such as tissue culture, genome sequencing, gene mapping, and molecular biomarkers for trait identification.

For example, the recent pairing of genome sequencing and mapping with conventional plant breeding by ICAR has led to the development of high-yielding, disease- and pest-resistant crop varieties. These modern varieties have significantly contributed to increased food production and the nation's food self-sufficiency. In the crop year 2024-25, India produced 14.9 million tonnes of rice, overtaking China (14.4 million tonnes) as the world’s top rice producer.

Without modern science and biotechnology, particularly in agriculture, this success would not have been possible. The application of modern technology in agriculture is vital, but it should remain accessible to small farmers, safe for the environment and human health, and, above all, it should raise the incomes and livelihoods of the millions of small farmers and the rural poor.

A key question that many in the public are asking is: who will benefit when a particular technology is applied? The core technology of gene editing, CRISPR-Cas, is patented and monopolised by CRISPR Therapeutics, Editas Medicine, the Broad Institute (USA), and other Western multinational companies. ICAR acquired the academic licence for this patented technology from the Broad Institute in 2016 (Patent no. 420873, dated 8.3.2023).

Rumours suggest that ICAR intends to partner with private seed companies to mass-produce the seeds of these two rice varieties, making them widely available on the market. This raises important questions about the commercial use of an academic licence, the cost of the seeds, and other related issues. Will farmers once again face high seed prices, as was the case with Bt cotton, developed by Mahyco in collaboration with Monsanto?

SDN1 and SDN2 are mutagenic tools used for either swapping or knocking out specific genes to enhance the expression of particular traits. Traits such as high yield, drought tolerance, or salinity resistance are not regulated by a single gene but are instead the result of the combined action of several genes, often located on different chromosomes across the plant genome.

Nitty gritties

Manipulating a single gene or knocking out a specific allele (of inhibitory action) may not provide long-term durability. This was observed with Bt cotton, introduced in 2002, where resistance to the bollworm became ineffective over time, and the crop became susceptible to the pink bollworm and other pests.

Any technology aimed at improving polygenic traits like high yield or salinity tolerance must account for the combined actions of genes that control factors such as root characteristics, mineral absorption, photosynthesis, leaf osmosis and tiller numbers.

Emerging multiplex genome-editing techniques, such as improved CRISPR-Cas9, allow for the simultaneous modification of multiple DNA loci in the genome. This approach enables the precise modification of multiple genes, improving traits like yield, pest resistance and nutritional quality.

To achieve long-lasting results, genetic research must be complemented with a local ecological approach. A holistic research method ensures that local ecosystems (including plant-soil-insect-microbe-environment interactions) are preserved while also safeguarding biodiversity and human health.

A robust regulatory framework is essential to confirm the safety, efficacy, and ethical use of gene-edited crops, while fostering an environment that encourages scientific discovery and technological progress. At least four gene-edited crops — non-browning bananas, less pungent crops, and those with lower levels of glufosinate — have emerged.

In March 2022, the Ministry of Environment exempted certain types of genome-edited crops from the stringent biosafety regulations that apply to GM crops.

The ministry exempted site-directed nucleases (SDN1 and SDN2) from specific rules under the Environment Protection Act, thereby allowing both public and private research laboratories to bypass the long approval process via the Genetic Engineering Appraisal Committee (GEAC). Currently, the regulation of biosafety and environmental checks is limited to the developer laboratory’s In-house Biosafety Committee (ISBC), with recommendations examined by GEAC.

Public sector research laboratories, like ICAR and state agricultural universities, have different mandates than profit-seeking private seed companies. The public sector focuses on developing technologies that align with local ecosystems, aiming to boost food production and improve the incomes and livelihoods of small farmers and the rural poor, without compromising health, biosafety and environmental concerns.

India should establish an independent biosafety institute to assess the merits of farm products developed through modern biotechnology. The nation’s regulatory authority must critically examine each case before approving new technologies, ensuring that biosafety, local ecology, and farmers' livelihoods are not compromised.

The application of modern biotechnology, including gene-edited crop development, is essential, but it must align with local agro-ecosystems to be truly effective.

Soma Marla is a retired Principal Scientist, Crop Genomics, ICAR NBPGR, New Delhi

Views expressed are author's own and don't necessarily reflect those of Down To Earth