From Gene Modification to Genome Editing – India’s Journey

UPSC Syllabus Topic: GS Paper 3 -science and technology.

Introduction

India’s biotechnology journey has moved from first-generation gene modification (GM) towards more precise genome editing using tools like CRISPR. While GM crops largely stalled after Bt cotton, genome-edited (GE) crops and therapies now enjoy stronger policy support, indigenous R&D and growing applications in both agriculture and health.

Gene Modification (GM) vs Genome Editing (GE)

Technique

Gene modification creates genetically modified (GM) crops by inserting one or more genes from another organism, often an unrelated species. A key Indian example is Bt cotton, where a gene from the soil bacterium Bacillus thuringiensis was inserted into cotton to give insect resistance.

Genome editing creates genome-edited (GE) crops by using tools such as CRISPR-associated proteins (like Cas9 or Cas12a) to cut and modify genes that are already present in the plant. The edit is guided by a short RNA sequence, so a specific native gene is altered rather than a foreign gene being added.

Regulation in India

1. GM crops that contain foreign DNA have to follow the full biosafety pathway under the Environment (Protection) Act Rules, 1989, and need clearance from the Genetic Engineering Appraisal Committee (GEAC) for environmental release, including field trials.
2. In March 2022, the Environment Ministry issued an Office Memorandum stating that certain genome-edited plants which are free from exogenous (introduced) DNA—specifically SDN-1 and SDN-2 categories—are exempted from the more stringent provisions of these Rules.
3. For such SDN-1 and SDN-2 genome-edited plants, the biosafety review under the 1989 Rules ends at the Institutional Biosafety Committee (IBSC), once it confirms that the final plant is free from foreign DNA.

Phase I – Introduction of Gene Modification (GM) in India

1. India’s modern biotechnology journey began with gene modification, where foreign genes were inserted into crops to provide specific traits.
   2. The most important milestone was the introduction of Bt cotton, which carries a gene from the bacterium Bacillus thuringiensis to resist bollworms.
   3. This marked India’s entry into the era of genetically modified (GM) crops and showed that biotechnology could directly improve farm-level productivity and pest resistance.

Phase II – Stagnation and Controversies Around GM Crops

1. After the initial success of Bt cotton, India’s GM story entered a phase of stagnation. No new GM crop technology was approved for commercial cultivation for many years.
   2. Attempts to introduce GM food crops such as Bt brinjal and GM mustard faced strong opposition from civil society groups, farmers’ organisations and some state governments.
   3. Concerns were raised over biosafety, long-term health effects, environmental risks and corporate control over seeds.
   4. Court cases and regulatory caution further slowed the process. As a result, India remained effectively limited to Bt cotton, and the country was seen as having underused the full potential of GM technology.

Phase III – Policy and Regulatory Shift Towards Genome Editing

1. A clear shift began when India moved from classical GM to genome editing.
2. Building on the 2022 decision that exempted SDN-1 and SDN-2 genome-edited plants without foreign DNA from the stringent 1989 Rules, many genome-edited crops would no longer require clearance from the Genetic Engineering Appraisal Committee (GEAC) for environmental release.
3. The Department of Biotechnology then released detailed guidelines and SOPs for safety assessment of genome-edited plants.
   4. The Union Budget 2023–24 earmarked a dedicated allocation of ₹500 crore for genome editing, with ₹310 crore for field crops, ₹120 crore for horticulture and the rest for animal science, fisheries and microorganisms.
4. ICAR has identified 178 genes in 24 field crops and 43 genes in 16 horticultural crops for editing.
   
5. Together, these steps signalled a policy decision to actively promote genome editing as a preferred route for crop improvement.

Phase IV – Field Applications of Genome Editing in Crops

Genome-edited rice and mustard

1. In 2025, two GE rice lines derived from Samba Mahsuri and MTU-1010 completed multi-location trials (2023 and 2024 kharif). They show around 19% higher yield and better tolerance to saline and alkaline soils.
   2. Parallel reporting notes India’s first genome-edited rice varieties – DRR Dhan 100 (Kamala) and Pusa DST Rice 1 – designed to use less water while maintaining or increasing yields, signalling a potential water-saving “game changer”.
   3. A GE mustard line with low pungency and resistance to major fungal pathogens and pests is under second-year trials and may be ready for release around 2026.

Building Indigenous Tools and Capacity

How CRISPR is used

• India’s GE crops use CRISPR-Cas9 and Cas12a to “edit” native genes controlling traits like drought and salt tolerance (in MTU-1010) and yield-linked genes like Gn1a in Samba Mahsuri.
• The Cas proteins appear only in the first generation; later selected plants are transgene-free, differentiating them from GM crops that permanently carry foreign genes.

Indigenous tools and capacity building

• ICAR and IARI have sent Indian scientists for advanced genome-editing training to the US, Europe, Australia and CIMMYT.
• Experts from Jennifer Doudna’s Innovative Genomics Institute trained faculty at IARI in 2025 and shared next-generation tools like GeoCas9 and CasLambda.
• A team led by Kutubuddin Ali Molla has patented an indigenous “miniature” genome-editing tool based on TnpB proteins, claimed to be cheaper and potentially more efficient than Cas9 and Cas12a because of smaller protein size and local IP control.

Beyond Crops: Gene and Cell Therapies in Health

Parallel to developments in agriculture, India’s genome-editing journey now extends into human health.

1. NexCAR19, an indigenous CAR-T cell therapy for blood cancers, received CDSCO approval in 2023 and is being deployed at a fraction of typical global CAR-T costs, positioning India on the global map of cell and gene therapy.
2. India is pursuing gene-editing solutions for sickle cell disease under a mission to eradicate the disease by 2047, with CRISPR therapies highlighted as potential one-time cures.
3. In November 2025, the government launched BIRSA-101, India’s first indigenous CRISPR-based gene therapy for sickle cell disease, specifically targeting tribal populations.
4. These examples show that India’s shift to genome editing is not just about crops but part of a broader bio-innovation ecosystem.

Way forward

1. Strengthen biosafety and transparency: Keep lighter rules for SDN-1 and SDN-2, but ensure robust risk assessment, labelling norms where needed, and transparent public communication to avoid a repeat of GM-era mistrust.
2. Focus on climate resilience and nutrition: Prioritise edits that improve drought, flood and salinity tolerance, disease resistance, micronutrient content and reduce input use, aligning with food and nutritional security goals.
3. Democratise access to gene and cell therapies: Extend public funding, innovative pricing and manufacturing models so treatments like NexCAR19 and BIRSA-101 are not confined to a few elite hospitals.
4. Invest in indigenous platforms and skills: Support Indian toolkits (like TnpB-based editors), shared biomanufacturing facilities and training programs so researchers across states can use advanced genome-editing without prohibitive IP or equipment costs.
5. Build ethical and legal frameworks: Update bioethics guidelines, consent frameworks and data-sharing rules to keep pace with human gene editing and ensure equity, safety and respect for rights.

Conclusion

India’s journey from gene modification to genome editing reflects a shift from controversial, slow-moving GM crops to policy-backed, largely indigenous genome-editing programmes in agriculture and health. GM cotton remains the lone commercial success, but genome-edited rice, mustard and other crops, along with CAR-T and CRISPR-based therapies, show that India is now shaping, not just importing, frontier biotechnologies. If regulatory vigilance, public trust and equitable access are sustained, genome editing can become a powerful, home-grown tool for India’s food security and public health in the coming decades.

Question for practice:

Discuss how India’s regulatory and technological shift from gene modification to genome editing is shaping its agricultural and healthcare innovation landscape.

Source: Indian Express