Genetic Engineering, GM Crops, Gene Editing and Vaccines

Prerequisites: Biotechnology and Health — overview · Agriculture and Food Security

The Hook: A Mustard Seed Splits the Supreme Court

The Core Concept

Biotechnology is the use of living organisms, cells or their parts to make products or solve problems. Brewing and curd-making are old biotechnology; modern biotechnology begins with the ability to cut, copy and move genes.

How recombinant DNA technology works (in one paragraph)

Restriction enzymes act as “molecular scissors” that cut DNA at specific sequences. The gene of interest is cut out of the donor organism and pasted into a carrier, or vector — usually a bacterial plasmid — using the enzyme DNA ligase (“molecular glue”). The recombinant plasmid is introduced into a host (often the bacterium E. coli, or a plant cell via Agrobacterium), which copies the gene and makes its protein. Cells that took up the gene are picked out with selectable markers. Human insulin made this way became the first recombinant DNA drug, approved in 1982.

graph LR
    A[Isolate DNA from donor] --> B[Cut gene with restriction enzyme]
    B --> C[Insert into plasmid vector with ligase]
    C --> D[Introduce into host cell]
    D --> E[Select transformed cells]
    E --> F[Host expresses the new protein or trait]

Applications at a glance

GM crops in India

How Bt works: the bacterium makes the Cry protein as an inactive protoxin. In the alkaline gut of a caterpillar it becomes active, binds to the gut lining and punches pores in it, killing the larva. Mammalian guts are acidic and lack the receptors, which is why the toxin is considered safe for humans.

Who regulates GM organisms

India regulates GM organisms under the Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms, Genetically Engineered Organisms or Cells, 1989, framed under the Environment (Protection) Act, 1986.

Internationally, India is a party to the Cartagena Protocol on Biosafety (adopted 2000, in force 2003) under the Convention on Biological Diversity, which governs the safe transboundary movement of living modified organisms.

Gene editing — the next step

CRISPR-Cas9 is a gene-editing tool adapted from a bacterial immune system. A short guide RNA leads the Cas9 enzyme to a matching DNA sequence, where it makes a cut; the cell’s own repair process then disables, corrects or replaces the gene. Emmanuelle Charpentier and Jennifer Doudna received the 2020 Nobel Prize in Chemistry for it.

The logic of the 2022 exemption: SDN-1 and SDN-2 changes are similar to those produced by conventional breeding or natural mutation. In May 2025, ICAR released two genome-edited rice varieties — DRR Dhan 100 (Kamala) and Pusa DST Rice 1 — developed with this approach.

In medicine, the first approved CRISPR therapy, Casgevy, was cleared in the UK (November 2023) and the USA (December 2023) for sickle cell disease and beta-thalassaemia. India launched the National Sickle Cell Anaemia Elimination Mission in July 2023, with the goal of eliminating the disease as a public health problem by 2047.

Vaccines — platforms you must know

A vaccine shows the immune system a harmless version or part of a pathogen so that it remembers it.

Katalin Karikó and Drew Weissman received the 2023 Nobel Prize in Physiology or Medicine for nucleoside base modifications that made mRNA vaccines practical.

Other health biotechnology

• Stem cells — undifferentiated cells that can renew themselves and become specialised cells. Embryonic stem cells are pluripotent; induced pluripotent stem cells (iPSCs) are made by reprogramming adult cells (Shinya Yamanaka, Nobel Prize 2012).
• Gene therapy — correcting a defective gene inside a patient’s cells, either outside the body (ex vivo) or inside it (in vivo).
• CAR-T cell therapy — a patient’s T-cells are engineered to recognise and kill cancer cells. NexCAR19, developed by ImmunoACT with IIT Bombay, was approved by India’s drug regulator in 2023 as the first indigenous CAR-T therapy.

India’s status

• Department of Biotechnology (1986) under the Ministry of Science and Technology; BIRAC supports biotech start-ups.
• The BioE3 Policy (Biotechnology for Economy, Environment and Employment), approved in August 2024, promotes biomanufacturing in areas such as bio-based chemicals, smart proteins, precision biotherapeutics and climate-resilient agriculture.
• The Genome India Project (DBT) set out to sequence 10,000 genomes from across India’s population groups.
• India is a major vaccine manufacturer; during COVID-19 it ran the CoWIN-based vaccination drive and supplied vaccines abroad under Vaccine Maitri.

Issues

• Biosafety: gene flow to wild relatives, effects on pollinators and soil organisms, resistance in pests (pink bollworm has developed resistance to Bt cotton).
• Herbicide-tolerant crops: concern about weedicide overuse and loss of farm labour; illegal HTBt cotton has been reported.
• Seed sovereignty and cost: dependence on proprietary seed and trait fees; farmers’ rights under the PPV&FR Act, 2001.
• Regulatory trust: the GEAC’s independence, transparency of biosafety data, and the role of States (agriculture is a State subject).
• Ethics: human germline editing, consent, genetic privacy and equitable access to costly gene therapies.

Memory Anchors

rDNA toolkit: “Scissors, Glue, Vehicle, Home” → restriction enzyme, ligase, vector, host.

GM crop timeline: “02 – 10 – 22” → Bt cotton approved (2002), Bt brinjal moratorium (2010), GM mustard release (2022).

SDN ladder: 1 = cut, 2 = correct, 3 = carry in a new gene. Only the third carries foreign DNA, so only the third is treated as GM.

For Prelims

For Mains

• Dimensions: food and nutrition security; farm incomes and input costs; biosafety and the precautionary principle; federalism (States’ role in agriculture); trade (GM-free export markets); ethics of human gene editing; affordability of new therapies.
• Keywords: precautionary principle, biosafety dossier, gene flow, refugia, trait value, seed sovereignty, product-based vs process-based regulation, biomanufacturing.
• Value-addition: Supreme Court split verdict on GM mustard (July 2024) and its direction for a national GM policy; MoEFCC exemption for SDN-1/SDN-2 (2022); genome-edited rice (2025); BioE3 Policy (2024); Cartagena Protocol.

Common Traps

In the News

• July 2024 — Supreme Court split verdict on GM mustard; both judges direct the Centre to frame a national GM crop policy.
• August 2024 — Union Cabinet approves the BioE3 Policy.
• May 2025 — ICAR releases two genome-edited rice varieties. Track follow-ups on the current affairs page.

Practice

Prelims

Mains

Quick Revision

Key Takeaways

Related Topics

• Biotechnology and Health — quick revision
• Biotechnology and Health — practice questions
• Intellectual Property Rights — patents on seeds and medicines
• Agriculture and Food Security
• Biodiversity and Conservation
• Nanotechnology and New Materials — lipid nanoparticles in mRNA vaccines