Science & Tech· Prelims · GS-III
Rewriting Life: Biotechnology and Genetic Engineering
From reading DNA to rewriting it: genome sequencing, the Genome India Project, CRISPR, gene therapy and India's indigenous CAR-T breakthrough, with the BioE3 policy framing the bioeconomy push.
Biotechnology is the use of living organisms, or the biological systems and processes derived from them, to make products and solve human problems in health, farming, industry and the environment. Few fields touch the UPSC syllabus at as many points: one chapter can throw up prelims facts on vaccines and gene editing, and mains questions on bioethics, food security and the bioeconomy, the part of national output generated from biological resources and processes.
The living toolkit: what biotechnology is
At its simplest, biotechnology means putting biology to work. When yeast ferments sugar into alcohol, that is traditional biotechnology. When scientists reprogram a bacterium to manufacture human insulin, that is modern biotechnology, built on understanding and manipulating DNA, the molecule that carries the instructions for building and running a living cell. The field is often colour-coded by application, a classification UPSC frequently tests.
- Red biotechnology covers medical and healthcare uses: drugs, vaccines, gene therapy and diagnostics.
- Green biotechnology covers agriculture: genetically modified crops, biofertilisers and pest-resistant varieties.
- White biotechnology covers industry: biofuels, bioplastics, enzymes and fermentation-based manufacturing.
- Grey biotechnology covers the environment: bioremediation, or cleaning pollution with microbes, and waste treatment.
- Blue biotechnology covers marine resources: aquaculture, marine drugs and algae-based products.
- Yellow biotechnology covers food and nutrition: fermentation, fortified foods and probiotics.
The standard international definition, and the one the UPSC drew on in its 2018 and 2019 papers, comes from the United Nations Convention on Biological Diversity (UNCBD): 'Biotechnology encompasses any technological application that utilizes biological systems, living organisms, or their derivatives to create or modify products and processes for specific purposes.' The operative phrase is 'for specific purposes': a technique counts as biotechnology only when biology is deliberately harnessed to make or modify something useful.
India's bioeconomy has grown from about $10 billion in 2014 to over $165 billion in 2024, according to the India BioEconomy Report released by the Department of Biotechnology (DBT), with a stated ambition of $300 billion by 2030 and $1 trillion by 2047. India ranks among the world's largest biotech economies, holds the second-highest number of USFDA-approved manufacturing plants outside the US, and saw its biotech company count rise from 5,365 in 2021 to 10,075 in 2024. Just five states, Maharashtra, Karnataka, Telangana, Gujarat and Andhra Pradesh, generate more than two-thirds of this value, a concentration the government wants future biotech clusters to correct.
The India BioEconomy Report, published by the DBT, divides this bioeconomy into five segments:
Segment | What it covers |
|---|---|
Bio-Pharma | Vaccines, biosimilars and biopharmaceuticals; India is the world's largest vaccine manufacturer |
Bio-Services | Contract research, clinical trials and data services |
Bio-Agriculture | Bt cotton, biopesticides, biofertilisers and biostimulants |
Bio-Industrial | Enzymes, biofuels and bio-based chemicals |
Bioinformatics | Genomic data analysis and computational biology |
Reading the code of life: genome sequencing
A genome is the complete set of genetic instructions of an organism, all its DNA, including every gene. A gene is the basic unit of heredity, a stretch of DNA that carries the code for a protein or a regulatory function. Genome sequencing is the process of determining the exact order of the four DNA bases, adenine (A), cytosine (C), guanine (G) and thymine (T), along a strand of DNA. Think of it as reading the full instruction manual of life, letter by letter.
Sequencing typically runs through four steps. First, DNA shearing cuts long DNA into small fragments. Second, DNA barcoding tags each fragment so its origin can be tracked. Third, the sequencer reads the bases on every fragment. Fourth, bioinformatics, the use of computation to analyse biological data, reassembles the fragments and compares sequences to spot variations linked to disease, ancestry or traits.
The applications explain why governments fund it. In medicine, sequencing powers prenatal screening, rare-disease diagnosis and cancer genomics. In pharmacogenomics, the study of how genes affect drug response, it predicts who will benefit from a drug and who may suffer side effects. During the COVID-19 pandemic, rapid sequencing of the viral genome let scientists design vaccines and track new variants. In agriculture it speeds up breeding for disease resistance, and in forensics it identifies individuals from minute biological traces. The limits matter too: sequencing generates enormous data that needs advanced computing, it can miss large structural changes in DNA, much of the variation it finds has no known medical meaning yet, and the intimate nature of genetic data raises hard questions about privacy, insurance discrimination and consent.
Mapping a billion people: the Genome India Project
The Genome India Project is a DBT-funded flagship programme, launched in January 2020, that set out to sequence the whole genomes of 10,000 Indians drawn from the country's diverse population groups. The logic is simple: global genetic databases are dominated by Western populations, so a drug dose, a disease-risk estimate or a diagnostic test calibrated abroad may simply not fit Indian bodies. India needed its own reference genome, a standard map of Indian genetic variation against which individual patients can be compared.
In February 2024 the Department of Biotechnology announced that whole genome sequencing of 10,074 individuals was complete. The data is archived at the Indian Biological Data Centre (IBDC) at Faridabad, India's first national life-science data repository, and a biobank of 20,000 blood samples has been established at the Centre for Brain Research at IISc Bengaluru for future research. Twenty institutions across the country, from IITs and AIIMS to CSIR laboratories, collaborated on the effort.
The first scientific harvest, published in Nature Genetics in April 2025, reported about 180 million genetic variants from 9,772 individuals, including roughly 44 million variants never seen in global databases. Early findings already matter for Indian medicine: the MYBPC3 mutation, a risk factor for cardiac conditions, was found in about 4 percent of Indians sampled, and population-specific patterns of anaesthesia response and cancer predisposition emerged from the data. A companion effort, IndiGen, undertaken by the Council of Scientific and Industrial Research (CSIR) from April 2019, sequences diverse ethnic groups to enable genetic epidemiology, the study of how genes shape disease patterns in populations.
Phase two of Genome India will compare the genomes of healthy people with those suffering from cancers, diabetes, neurological conditions and rare genetic diseases, hunting for the mutations that predispose Indians to illness. That comparison is the gateway to precision medicine, treatment tailored to a patient's genetic makeup rather than one-size-fits-all prescriptions, which is why the project is described as foundational infrastructure for Indian healthcare.
Rewriting the code: genetic engineering
Genetic engineering is the deliberate insertion, deletion or modification of genetic material in a cell to change an organism's characteristics. If sequencing is reading the manual of life, genetic engineering is editing it. Four toolkits dominate the field. Recombinant DNA technology moves a gene from one species into another, the classic example being bacteria engineered to produce human insulin. Gene editing tools such as CRISPR-Cas9, TALENs and ZFNs cut DNA at precise locations so faulty sequences can be repaired or removed. Gene silencing through RNA interference switches specific genes off without altering the DNA itself. And transgenesis creates organisms carrying foreign genes, such as pest-resistant crops.
CRISPR-Cas9 deserves its reputation as the defining tool of modern biology. Bacteria naturally use the CRISPR system as an immune memory: when a virus attacks, the bacterium stores a snippet of viral DNA and uses the Cas9 protein as molecular scissors to cut matching viral DNA on the next encounter. Scientists reprogrammed this defence into a programmable editor by attaching a guide RNA that leads Cas9 to any chosen DNA sequence. Because it is cheaper, faster and more precise than earlier methods, CRISPR is now in clinical trials for conditions like sickle cell anaemia, where a patient's own blood stem cells are edited to produce healthy haemoglobin.
Agriculture shows both the promise and the politics. Bt cotton, engineered with a bacterial gene that kills bollworm pests, covers the overwhelming majority of India's cotton area and is the country's most successful genetically modified crop. Golden Rice, fortified with beta-carotene that the body converts to vitamin A, targets hidden hunger. Indian researchers have developed Sahbhagi Dhan, a drought-tolerant rice variety, and ADVIKA, a drought-tolerant chickpea unveiled in late 2023. In medicine, engineered cells produce growth hormones and monoclonal antibodies, laboratory-made proteins that target specific disease molecules, while xenotransplantation research edits pig organs so they might one day be transplanted into humans.
Two frontiers beyond editing deserve their dictionary definitions. A gene drive is a genetic system engineered to spread a chosen set of genes rapidly through a wild population, biasing inheritance so that nearly all offspring carry the trait; researchers propose using it to suppress malaria-transmitting mosquitoes, which is also why ecologists fear an accidental release could be irreversible. Synthetic biology goes further: it redesigns existing biological organisms and even crafts entirely new forms of life, treating DNA as programmable code for manufacturing medicines, materials and fuels.
India is moving from CRISPR reader to CRISPR writer. At the National Agri-Food Biotechnology Institute (NABI) in Mohali, scientists used CRISPR-Cas9 to edit the banana genome, boosting beta-carotene up to sixfold for vitamin A enrichment, a first for a fruit crop in India. The Indian Agricultural Research Institute's Pusa Rice DST1 edits the DST gene for drought tolerance, with field tests underway. In medicine, the November 2025 unveiling of BIRSA-101 at CSIR-IGIB Delhi gave India its first indigenous CRISPR-based gene therapy for sickle cell disease, built on the home-grown enFnCas9 platform and licensed to the Serum Institute of India for affordable scale-up, in line with the national goal of a sickle-cell-free India by 2047.
India regulates this power through the Genetic Engineering Appraisal Committee (GEAC), the apex body under the Ministry of Environment, Forest and Climate Change that approves genetically modified organisms. The cautionary tale is Bt brinjal, placed under a moratorium in 2010 after public protests. Its counterpoint is Dhara Mustard Hybrid-11 (DMH-11), a GM mustard cleared by the GEAC in 2022 amid continuing legal scrutiny in the Supreme Court. In 2022 India also exempted SDN-1 and SDN-2 genome-edited plants, edits that introduce no foreign DNA, from the strictest biosafety regulations, signalling that regulation will distinguish between transgenic organisms and precise edits. The enduring concerns are gene flow to wild relatives, corporate control of seed markets, and whether long-term ecological effects are fully understood.
Three gene-editing tools work on the same cut-and-repair principle but differ in precision and cost:
Tool | How it works | Why it matters |
|---|---|---|
CRISPR-Cas9 | A guide RNA steers the Cas9 enzyme to a matching DNA sequence, where it cuts both strands: the famous "genetic scissors" | Modelled on the bacterial immune system; cheapest, fastest and most precise |
Zinc finger nucleases (ZFNs) | Engineered proteins that grip specific DNA triplets, fused to a DNA-cutting enzyme | Precise but costly and hard to design |
TALENs | Engineered proteins that read DNA one base at a time, fused to a cutting enzyme | More flexible than ZFNs, but bulkier to build |
Healing at the root: gene therapy
Gene therapy is a medical technique that treats or prevents disease by modifying a patient's genes: introducing a working copy of a faulty gene, silencing a harmful one, or repairing a mutation at its source. Unlike drugs that manage symptoms, gene therapy aims at the root cause, which makes it most powerful against monogenic disorders, diseases caused by a defect in a single gene.
India entered this frontier with its first-in-human gene therapy trial for haemophilia A, a bleeding disorder caused by missing or defective Factor VIII, a blood-clotting protein. Scientists at the Christian Medical College (CMC) Vellore, supported by the DBT and the Centre for Stem Cell Research (a unit of inStem Bengaluru), used a lentiviral vector, a modified virus, to insert a working Factor VIII gene into the patients' own blood-forming stem cells. The single-centre study enrolled five participants aged 22 to 41 and reported zero annualised bleeding rates with sustained Factor VIII production, results published online in the New England Journal of Medicine in December 2024. The stakes are large: India carries the world's second-largest haemophilia burden, an estimated 1.36 lakh people with haemophilia A, of whom only about 21,000 are registered, and lifelong clotting-factor infusions are expensive and burdensome.
A living drug: CAR-T cell therapy
CAR-T cell therapy, short for Chimeric Antigen Receptor T-cell therapy, is an advanced form of gene therapy that turns a patient's own immune cells into a cancer treatment, earning it the nickname of a living drug. T-cells are white blood cells that patrol the body for abnormal cells, but cancers often evade them. In CAR-T therapy, T-cells are extracted from the patient's blood through leukapheresis, genetically modified in a laboratory using a viral vector to carry a synthetic receptor (the CAR) that recognises a specific protein on cancer cells, multiplied into the billions, and infused back. The reprogrammed cells hunt down the cancer and keep multiplying inside the body, giving a long-lasting, self-sustaining attack.
Manufacturing a CAR-T dose takes three steps. First, T cells are collected from the patient's blood in a process called leukapheresis. Second, the cells are engineered in a laboratory: a gene for a chimeric antigen receptor, a synthetic protein that recognises a cancer marker such as CD19, is inserted using a viral vector. Third, the engineered cells are infused back into the patient's bloodstream, where they multiply and hunt cancer cells through the body. Because they are living cells that persist and divide inside the patient, CAR-T products are called 'living drugs', a phrase that also captures their risk: once infused, they cannot be switched off easily.
India's breakthrough is NexCAR19, the country's first indigenously developed CAR-T therapy, created by ImmunoACT, a company incubated at IIT Bombay, in collaboration with the Tata Memorial Hospital. In October 2023 the Central Drugs Standard Control Organisation (CDSCO) granted it market authorisation for relapsed or refractory B-cell lymphoma and B-cell acute lymphoblastic leukaemia in patients aged 15 and above, based on trials in 60 patients showing about a 70 percent overall response rate. The therapy targets the CD19 protein found on cancerous B-cells. President Droupadi Murmu formally launched it at IIT Bombay in April 2024, and its price of roughly Rs 30 to 40 lakh, about one-tenth of the Rs 3 to 4 crore charged abroad, makes it a landmark in affordable innovation. A second indigenous therapy, Qartemi from Immuneel Therapeutics, won CDSCO approval in January 2025.
The therapy is not without risks. Cytokine release syndrome (CRS), a violent immune overreaction causing fever, low blood pressure and breathing difficulty, can be life-threatening, and neurological toxicity can cause delirium or seizures. Because CD19 also sits on healthy B-cells, treatment wipes those out too, an on-target, off-tumor effect. Cancers can also relapse by shedding the target protein, a trick called antigen escape, and the therapy works far better in blood cancers than in solid tumours. Manufacturing is personalised and logistically demanding, which is why researchers are racing toward allogeneic CAR-T cells, off-the-shelf treatments made from donor cells, combination therapies, and next-generation designs.
3D bioprinting
If genetic engineering rewrites the code of life, 3D bioprinting tries to print the tissue that code builds. It is an additive manufacturing technique that constructs three-dimensional biological structures layer by layer, depositing bio-inks, printable mixtures of living cells suspended in supportive biomaterials such as hydrogels, water-swollen polymer networks that mimic the soft, wet environment cells inhabit inside the body, through a computer-controlled nozzle. The printer follows a digital blueprint, often derived from a patient's own medical scans, placing cell-laden droplets or filaments with micrometre precision so the construct echoes the architecture of real tissue.
Three families of printers dominate. Extrusion bioprinting, the workhorse, pushes bio-ink through a nozzle like toothpaste and handles the densest cell loads. Inkjet bioprinting fires tiny droplets, faster and gentler but limited to runnier inks. Laser-assisted bioprinting uses a laser pulse to transfer cells from a donor slide, achieving the finest resolution at the highest cost. In every case the printed construct must mature in a bioreactor, a vessel that supplies nutrients, oxygen and mechanical cues while cells multiply, fuse and begin behaving like tissue. The hardest engineering problem is vascularisation, growing the tiny blood vessels without which any tissue thicker than a few millimetres starves at its core.
The honest state of the art is scaffolds, models and patches, not transplantable organs. Printed skin and cartilage constructs are in advanced research and early clinical testing for wound healing and joint repair. Pharmaceutical companies use bioprinted liver and heart-tissue models for drug testing, because a speck of human-like tissue predicts toxicity far better than animal models or flat cell cultures, cutting both animal testing and late-stage drug failures. Research groups have printed simplified kidneys, hearts and ears, but these are anatomical models or immature tissues, not functional organs ready for transplant; vascularisation and the immune complexity of a whole organ remain unsolved.
Globally the field is led by university laboratories and startups in the United States and Europe, with growing research output from China; in India, institutes including IITs and AIIMS are reported to be working on bioprinted skin, cartilage and bone scaffolds, though the work remains largely at the research stage. The regulatory questions are live everywhere: is a printed tissue a medical device, a biologic drug, or something new, and which regulator approves it? Using a patient's own cells, autologous sourcing, sidesteps immune rejection and much of the stem-cell ethics debate, but donor-cell and embryonic stem-cell lines raise consent and sourcing questions. Add biosecurity, engineered tissues could in principle be misused, and the garage-biology concerns of the previous section apply here too. For the exam, bioprinting sits at the intersection of biotechnology, materials science and medical ethics, which is exactly why it keeps appearing in questions.
India's biotech engine: policy and institutions
The institutional backbone is the Department of Biotechnology (DBT), which funds research and policy, and the Biotechnology Industry Research Assistance Council (BIRAC), which backs startups and industry partnerships. The National Biopharma Mission, launched in 2017 with World Bank co-funding of $250 million, supports affordable biopharmaceutical development, while the National Biotechnology Development Strategy (2021-25) set the recent policy direction. Flagship research homes include the National Institute of Immunology, the Centre for Cellular and Molecular Biology (CCMB), the National Centre for Biological Sciences (NCBS) and the IITs, and 94 incubators across 25 states now shepherd biotech startups.
The big policy bet is the BioE3 Policy, short for Biotechnology for Economy, Environment and Employment, approved by the Union Cabinet in August 2024. It aims to make India a global hub for high-performance biomanufacturing, producing medicines, materials and chemicals through biological rather than chemical processes, across the policy's six thematic sectors, backed by the Bio-RIDE scheme, with an outlay of Rs 9,197 crore, and by Bio-AI hubs that fuse artificial intelligence with biology. The vision is explicit: biotechnology as a growth pillar alongside information technology and energy, powering the road to a developed India by 2047.
Thematic sector | What it covers |
|---|---|
High-value bio-based chemicals, biopolymers and enzymes | Bio-based chemicals, biodegradable plastics and specialty enzymes that replace petrochemical routes |
Smart proteins and functional foods | Alternative proteins and nutrition products for health and food security |
Precision biotherapeutics | Gene and cell therapies, targeted biologics and personalised treatments |
Climate-resilient agriculture | Drought and heat tolerant crops and soil microbiome innovations |
Carbon capture and its utilisation | Algae and microbial systems that convert captured CO2 into fuels and materials |
Marine and space research | Biomanufacturing for food, health and materials in extreme environments |
Tool | What it does | Example in use |
|---|---|---|
Recombinant DNA technology | Moves a gene from one species into another | Human insulin produced in engineered bacteria |
CRISPR-Cas9 gene editing | Cuts DNA at a precise spot for repair or removal | Clinical trials correcting sickle cell anaemia |
RNA interference | Silences specific genes without changing DNA | Pest-resistant crops |
Transgenesis | Inserts foreign genes to create new traits | Bt cotton resisting bollworm |
Biosecurity in the garage age: DIY biology and its risks
A biohacker is a hobbyist or independent researcher who practises biology outside traditional laboratories, ordering DNA kits and gene-editing tools online the way an electronics hobbyist orders circuit boards. CRISPR-based kits that can cut and edit DNA are now sold commercially, and the convergence of AI models that can design genomic sequences with synthetic biology has pushed the entry barrier for pathogen engineering to a worrying low.
Biosecurity is the set of policies, practices and technologies that prevent biological research and materials from being misused. The concrete worry is engineered pathogens escaping a lab or being deliberately built, now that AI-designed sequences can be ordered as synthetic DNA. One proposed safeguard is digital watermarking of engineered organisms: inserting traceable DNA signatures into synthetic genomes so that any engineered microbe found in the wild can be traced back to its maker.
The same toolkit also serves forensics and cleanup. Lab-in-a-van DNA systems can identify disaster victims from samples within about ninety minutes; wildlife forensics uses DNA barcoding to trace ivory and pangolin scales back to poaching hotspots, curbing illegal trade; and engineered microbes are being put to work on pollution, from PETase enzymes that digest plastic to oil-zapper bacteria that clean spills and microbes designed to break down PFAS chemicals.
- Screen DNA synthesis orders for dangerous sequences before they are shipped, the way banks screen for fraud.
- Run the riskiest work in BSL-3 and BSL-4 containment labs, linked to One Health surveillance that watches for zoonotic spillovers from animals to humans.
- Stress-test biosecurity systems deliberately in controlled settings, so that blind spots are found by defenders before they are found by misuse.
- Extend international norms and export controls to cover AI-designed biological sequences, not just physical pathogens.
GM crops: India's contested harvest
A genetically modified (GM) crop is a plant whose genome has been altered by inserting one or more genes, usually with Agrobacterium or a gene gun, to give it a trait such as pest resistance. India has supplied some of prelims' most repeated questions from this theme, because the same few crops keep returning to the regulatory table.
How a transgenic plant is built
Three techniques insert foreign genes into plants. Recombinant DNA technology is the cut-and-paste core: restriction enzymes cut DNA at specific sites and a gene of interest, such as a bacterial insecticide gene, is pasted into a carrier molecule. A gene gun fires microscopic heavy-metal particles coated with the gene into plant cells with mechanical force, where the DNA integrates into the genome. Agrobacterium-mediated transformation exploits the soil bacterium Agrobacterium tumefaciens, which naturally transfers part of its own DNA into plant cells, to smuggle the gene of interest into the plant genome at essentially random positions.
The first commercial product of this toolkit was the Flavr Savr tomato, licensed for human consumption in the United States in 1994: an antisense gene suppressed the polygalacturonase enzyme that softens fruit, extending shelf life. Today GM soybean, maize and cotton dominate global biotech acreage, and people worldwide have consumed biotech crop products for over two decades.
Bollgard I cotton carries the cry1Ac gene from the soil bacterium Bacillus thuringiensis (Bt). Inside the plant the gene makes a protein toxin that kills bollworm larvae feeding on the crop, cutting pesticide use. It was the first Bt cotton cleared for India.
Bollgard II cotton carries two Bt genes, cry1Ac and cry2Ab, instead of one. The second toxin widens protection to more bollworm species and, crucially, slows the evolution of pest resistance, because an insect resistant to one toxin is still killed by the other. Prelims loves this pair: Bollgard I is cry1Ac alone, Bollgard II is cry1Ac plus cry2Ab.
DMH-11 is a genetically modified mustard developed at the University of Delhi using the barnase-barstar system. The barnase gene makes the plant male-sterile and the barstar gene restores fertility, a pairing that enables commercial hybrid seed production in a crop where hybridisation is otherwise difficult. Its clearance by the Genetic Engineering Appraisal Committee (GEAC) has been contested in courts and public debate.
Bt brinjal carries the cry1Ac gene for resistance to the fruit and shoot borer, and would have been India's first GM food crop. In 2010 the environment minister imposed a moratorium on its commercial release after public consultations across the country. Critics cited biosafety gaps, risks to brinjal's rich Indian biodiversity, and farmer dependence on seed companies; the moratorium still stands.
MON 863 is a Monsanto maize variety engineered for corn rootworm resistance. It became controversial when independent reanalysis of rat-feeding study data suggested possible liver and kidney effects, fuelling the allergenicity and toxicity debate around GM foods. Critics argued that regulatory safety assessments were too narrow; supporters pointed to approvals by multiple regulators. Prelims asks it as a name-recognition fact: MON 863 is a GM maize at the centre of a biosafety controversy.
Golden rice is rice engineered to produce beta-carotene, the orange pigment the body converts to vitamin A, in the grain endosperm. It was designed to fight vitamin A deficiency, a major cause of childhood blindness. Critics question how much vitamin A it can realistically deliver and argue for supplementation and dietary diversity instead. It remains the textbook example of a nutritionally enhanced GM crop.
Crop | Gene(s) | Status in India |
|---|---|---|
Bt cotton (Bollgard I) | cry1Ac | Approved; the only GM crop grown commercially in India |
Bt cotton (Bollgard II) | cry1Ac + cry2Ab | Approved; wider bollworm protection, slower resistance build-up |
Bt brinjal | cry1Ac | Moratorium on commercial release since 2010 |
DMH-11 mustard | barnase-barstar | GEAC clearance contested in courts and public debate |
Golden rice | beta-carotene pathway | Not in India; the classic nutrition biofortification example |
The regulatory ladder runs from laboratory to field. The Review Committee on Genetic Manipulation (RCGM), functioning under the Department of Biotechnology, monitors research and development work involving GMOs. The Genetic Engineering Appraisal Committee (GEAC), a statutory body under the Ministry of Environment, Forest and Climate Change, approves environmental release under the 1989 Rules framed under the Environment (Protection) Act, 1986. State Biotechnology Coordination Committees (SBCCs) review safety practices at the state level, and District Level Committees (DLCs) oversee field-level compliance. On the food side, the Food Safety and Standards Act, 2006 bars the import, manufacture or sale of GM food without FSSAI approval. Bt cotton remains the only GM crop approved for commercial cultivation in India, and its herbicide-tolerant variant HTBt cotton, resistant to the herbicide glyphosate, has not received regulatory approval.
Cloning: copying life
Cloning is the scientific process of creating genetically identical copies of a living organism or cell. The landmark is Dolly the sheep, born in 1996 as the first mammal cloned from an adult cell, which proved that a specialised cell's nucleus still carries the full genetic programme needed to build a whole animal.
The workhorse method is somatic cell nuclear transfer (SCNT): the nucleus of a somatic, or body, cell is transferred into an egg cell whose own nucleus has been removed, the egg is stimulated to divide, and the resulting embryo is implanted into a surrogate mother. Gene cloning, a narrower technique, copies individual genes to produce proteins or modify existing ones.
The method keeps making headlines. In 2022 the Beijing-based company Sinogene Biotechnology announced Maya, the world's first cloned wild Arctic wolf, born to a beagle surrogate after 85 embryos were transferred into seven surrogates. In April 2025 the US company Colossal Biosciences announced three pups, Romulus, Remus and Khaleesi, marketed as revived dire wolves extinct for 10,000 years; independent experts and the IUCN Species Survival Commission's Canid Specialist Group noted that the animals are genetically engineered grey wolves carrying about 20 edited genes, not members of the extinct species, a controversy that shows how marketing can outrun taxonomy.
The ethical objections are familiar: clones could be exploited for commercial or military purposes; genetic defects in the donor repeat in the clone; and human reproductive cloning, widely condemned, raises questions of identity, consent and the commodification of life.
Better breeds: biotechnology for livestock
Genetic improvement of livestock means selecting and multiplying animals with superior traits using assisted reproduction. Artificial insemination (AI) places selected semen directly into the female reproductive tract; in-vitro fertilisation (IVF) fertilises eggs outside the body; and embryo transfer technology (ETT) implants the resulting embryos into surrogate mothers. Together they raise milk and meat yields, conserve indigenous breeds and build disease-free, climate-resilient herds without depending on exotic breeds.
The policy architecture is in place. The Rashtriya Gokul Mission, launched in 2014, conserves and upgrades indigenous cattle through AI programmes, IVF, MAITRI doorstep services and progeny-tested bull production. In August 2021 the National Institute of Animal Biotechnology (NIAB), Hyderabad released IndiGau, India's first cattle genomic chip: with 11,496 single-nucleotide-polymorphism markers, the world's largest cattle chip at launch, it identifies pure indigenous breeds such as Gir, Sahiwal, Kankrej and Ongole. The National Livestock Mission supports breed development, the e-Pashuhaat portal connects farmers with breeders for bovine germplasm, and the NDDB's INAPH system tracks breeding, nutrition and health data in real time.
Biotechnology for energy independence by 2047
The UPSC 2025 mains paper asked how biotechnology can help India achieve energy independence by 2047, and the answer runs through biomass. Biotechnology converts farm residue into second-generation ethanol, cutting stubble burning while feeding the E20 ethanol-blending programme. Microbial processes turn organic waste into biogas and compressed bio-CNG under the GOBARdhan scheme and the SATAT initiative, which promotes bio-CNG as a transport fuel. Algae-based systems and engineered microbes capture carbon dioxide and convert it into fuels and materials, making biotechnology a bridge between the bioeconomy and a self-reliant, green energy system.
Frequently asked questions
What is the difference between gene therapy and gene editing?
Gene editing is a tool, it changes DNA sequences, as CRISPR-Cas9 does. Gene therapy is a treatment strategy that may use gene editing, or gene addition via vectors, to cure disease. All therapeutic gene editing is gene therapy, but not all gene therapy involves editing: the haemophilia A trial added a working gene without editing the faulty one.
Why does India need its own genome database?
Because genetic variation differs across populations, and global databases are dominated by European ancestry. Without an Indian reference, disease-risk estimates, drug doses and diagnostic tests calibrated abroad can mislead Indian doctors. Genome India fills that gap with 10,000 sequenced Indian genomes.
What is the BioE3 Policy?
BioE3 stands for Biotechnology for Economy, Environment and Employment. Approved in August 2024, it aims to make India a global hub for high-performance biomanufacturing across the policy's six thematic sectors: high-value bio-based chemicals, biopolymers and enzymes; smart proteins and functional foods; precision biotherapeutics; climate-resilient agriculture; carbon capture and its utilisation; and marine and space research.
Is CAR-T therapy a cure for cancer?
Not yet. It produces durable remissions in many blood-cancer patients who had exhausted other options, with about a 70 percent response rate in NexCAR19 trials, but relapses occur through antigen escape, it works poorly in solid tumours so far, and side effects like cytokine release syndrome need expert management. It is best seen as a transformative platform, not a universal cure.
Key Terms
- biotechnology: Biotechnology is the use of living organisms, cells or biological processes to develop products and technologies for medicine, agriculture, industry and the environment. It ranges from traditional fermentation to modern genetic engineering, gene editing and biopharmaceutical production. Example: Bt cotton, a genetically engineered insect-resistant variety widely grown in India, is a leading agricultural product of biotechnology.
- bioeconomy: The bioeconomy is the part of the economy based on biological resources and processes: agriculture, forestry, fisheries, food, biofuels, bioplastics, biotechnology products and bio-based services. It offers a pathway to decouple growth from fossil resources by valorising renewable biomass and waste streams into fuels, materials and medicines. India has set a target of a 300 billion dollar bioeconomy by 2030, backed by the BioE3 policy promoting high-performance biomanufacturing. Example: Ethanol blending in petrol and enzyme-based bioplastics are everyday outputs of the bioeconomy.
- DNA: DNA (deoxyribonucleic acid) is the hereditary molecule present in the nucleus of almost every cell, carrying the instructions for building and running an organism. It is a double helix of two sugar-phosphate strands linked by four nitrogenous bases (adenine, thymine, guanine and cytosine), whose sequence encodes genes. The order of these bases determines traits, and small variations in it explain differences between individuals and susceptibility to some diseases. Example: DNA profiling is used in forensics to match suspects to crime-scene samples or to identify disaster victims.
- Red biotechnology: Red biotechnology is the branch of biotechnology applied to medicine and healthcare. It covers the development of drugs, vaccines, diagnostics and therapies using living systems or their products. It is distinguished from green biotechnology (agriculture), white biotechnology (industrial processes) and blue biotechnology (marine resources). Example: Monoclonal antibodies used in cancer treatment and recombinant vaccines are products of red biotechnology.
- Green biotechnology: Green biotechnology is the colour-coded branch of biotechnology applied to agriculture and food production (green denotes agriculture in this scheme). It covers genetically modified and improved crop varieties, disease and pest-resistant plants, biofertilizers and biopesticides. Its promise is higher yields with lower chemical inputs, while its debates centre on biosafety, seed sovereignty and ecological effects of transgenic crops. Example: Bt cotton, engineered to resist bollworm pests, is the most widely adopted genetically modified crop in India.
- White biotechnology: White biotechnology, also called industrial biotechnology, is the use of living cells, enzymes and microorganisms in industrial processes to make products such as biofuels, bioplastics, enzymes and biochemicals. It offers a greener alternative to conventional chemical manufacturing by using renewable feedstocks, operating at lower temperatures and generating less toxic waste. It is central to the bioeconomy, circular economy and India's BioE3 policy for biomanufacturing. Example: Producing bioethanol from sugarcane molasses or agricultural residue through microbial fermentation is a classic white biotechnology process supporting India's ethanol blending programme.
- Grey biotechnology: Grey biotechnology is the colour-coded branch of biotechnology devoted to environmental protection and remediation (grey denotes the environment). It uses microbes, enzymes and plants to clean up polluted soil and water (bioremediation), treat industrial effluents and convert waste into useful products. It is central to low-cost, nature-based solutions for industrial pollution. Example: Oil-degrading bacteria are used to bioremediate sites contaminated by crude-oil spills.
- Blue biotechnology: The branch of biotechnology that uses marine and aquatic organisms, from algae and sponges to deep-sea microbes, as sources of new products and processes. It covers marine-derived drugs, enzymes, biomaterials, cosmetics and biofuels, and is prized because the oceans hold vast unexplored genetic diversity. It is distinct from red (medical), white (industrial), green (agricultural) and grey (environmental) biotechnology. Example: The painkiller ziconotide was developed from the venom of a marine cone snail, a classic blue-biotechnology product.
- Yellow biotechnology: Yellow biotechnology is the branch of biotechnology devoted to food production and nutrition, alongside red (medical), green (agricultural), white (industrial) and blue (marine) biotechnology in the colour classification. It covers fermentation technology, food processing, fortified foods, probiotics and food safety, applying biology to improve the quality, quantity and nutritional value of food. (In some alternative schemes the label is also applied to insect biotechnology, the use of insect-derived molecules and cells.) Example: Probiotic curd cultures and vitamin-fortified staple foods are products of yellow biotechnology.
- genome: The genome is the complete set of genetic instructions carried by an organism, consisting of all its DNA (in humans, about 3 billion base pairs organised into 23 pairs of chromosomes). It includes both the protein-coding genes and the regulatory regions that control how those genes are switched on and off. Reading genomes helps scientists trace evolution, diagnose inherited diseases, and guide breeding or medical therapy. Example: The Human Genome Project, completed in 2003, produced the first full reference sequence of the human genome.
- gene: A segment of DNA that carries the instructions for making a functional product, usually a protein and sometimes a functional RNA molecule. Genes are the basic units of heredity, passed from parents to offspring, and their variants (alleles) account for inherited differences between individuals. Gene expression, which genes are switched on or off in each cell, is what makes a root cell different from a leaf cell despite identical DNA. Example: The cry genes from the bacterium Bacillus thuringiensis, inserted into Bt cotton, produce a protein toxic to bollworm pests and sharply reduced pesticide use in India.
- Genome sequencing: Genome sequencing is the process of determining the complete DNA sequence of an organism's genome, including the order of its billions of nucleotide bases. It underpins precision medicine, disease surveillance and biodiversity research, and its cost has fallen dramatically since the Human Genome Project. Example: India's INSACOG network used genome sequencing to track SARS-CoV-2 variants such as Omicron during the pandemic.
- DNA shearing: DNA shearing is the deliberate fragmentation of long DNA molecules into shorter pieces before sequencing or analysis. It is done mechanically, by forcing DNA through narrow openings (nebulisation) or by ultrasound (sonication), or enzymatically with restriction enzymes, producing fragments of a controlled size range. Modern next-generation sequencing workflows need DNA in short, uniform fragments of a few hundred base pairs, so shearing is a standard first step in library preparation. Example: Sonication shears genomic DNA into 300 to 500 base-pair fragments before an Illumina sequencing run.
- DNA barcoding: DNA barcoding is a technique for identifying species using a short, standardised segment of DNA rather than whole genomes or physical appearance. An agreed-upon gene region, such as the COI gene in animals or rbcL and matK in plants, acts like a product barcode: its sequence is compared against a reference library to name the species. It is especially useful for identifying cryptic, juvenile or processed specimens that cannot be recognised by morphology. Example: Wildlife enforcement agencies use DNA barcoding to identify endangered species in seized shipments of animal parts or timber.
- sequencer: A sequencer is an instrument that determines the exact order of nucleotides (A, T, G, C) in a DNA or RNA strand, a process called sequencing. Modern high-throughput or next-generation sequencers can read billions of bases in a single run, making large-scale genome analysis routine and cheap. Sequencing is now fundamental to medicine, agriculture and biodiversity research. Example: Sequencers were used to track SARS-CoV-2 variants by reading viral genomes from patient samples.
- bioinformatics: Bioinformatics is the interdisciplinary field that applies computer science, statistics and mathematics to store, analyse and interpret biological data, especially DNA, RNA and protein sequences. It makes modern genomics possible by assembling raw sequencing reads into genomes, predicting gene function, modelling protein structures and comparing evolutionary relationships across species. It is indispensable in drug discovery, precision medicine, crop improvement and pandemic surveillance. Example: Tracking SARS-CoV-2 variants during the pandemic relied on bioinformatics pipelines that assembled and compared thousands of viral genomes.
- pharmacogenomics: Pharmacogenomics is the study of how a person's genetic makeup affects their response to drugs, used to predict both efficacy and adverse reactions. It enables personalised medicine, in which drug choices and doses are tailored to a patient's genes rather than given one-size-fits-all. Regulatory agencies increasingly include pharmacogenomic information on drug labels. Example: Testing for the HLA-B*1502 gene variant, common in Asian populations, before prescribing carbamazepine, since carriers face a high risk of severe skin reactions.
- Genome India Project: The Genome India Project is a Department of Biotechnology initiative launched in 2020 to sequence 10,000 genomes representing India's diverse populations. It aims to build a reference database of Indian genetic variation to support precision medicine, disease prediction and targeted drug development. Example: The project sequences 10,000 genomes from diverse Indian populations to map genetic variants linked to diseases common in India.
- reference genome: A reference genome is a complete, high-quality DNA sequence assembled to serve as the standard map against which individual genomes are compared. Researchers align a person's sequenced DNA to the reference to spot variations linked to disease or traits. The first human reference genome was completed by the Human Genome Project in 2003, and population-specific references improve accuracy for underrepresented groups. Example: India's GenomeIndia project, which is sequencing 10,000 genomes to build a reference capturing the country's genetic diversity.
- Nature Genetics: A leading monthly peer-reviewed scientific journal, published by the Nature Portfolio, devoted to research in genetics and genomics. It publishes high-impact studies on gene function, genetic variation, genome sequencing and the genetic basis of disease, and is widely cited in biomedical research. Example: Genome-wide association studies identifying genetic variants linked to diseases such as diabetes are routinely published in this journal.
- MYBPC3: A gene that codes for myosin-binding protein C, a structural protein of the heart muscle, whose mutations raise the risk of hypertrophic cardiomyopathy (abnormal thickening of the heart). Population studies in India found a variant of this gene to be common in about 4 per cent of Indians, underlining why precision medicine needs population-specific genetic catalogues rather than Western reference databases. Example: The MYBPC3 variant common in South Asian populations is used in Indian genetics teaching as a case for building an India-specific human genome reference.
- IndiGen: IndiGen is a CSIR programme launched in April 2019 to sequence the genomes of diverse Indian ethnic groups for genetic epidemiology, the study of how genes shape disease patterns in populations. It complements the Genome India Project, which catalogued millions of variants and found, for instance, the MYBPC3 cardiac-risk mutation in about 4.5 per cent of Indians sampled. Example: IndiGen's population-specific data helps explain Indian patterns of anaesthesia response and cancer predisposition.
- precision medicine: Precision medicine is an approach to treatment that tailors prevention, diagnosis and therapy to an individual patient's genes, environment and lifestyle rather than using one-size-fits-all protocols. It relies on genomic sequencing, biomarkers and data analytics to predict which drug or dose will work for a specific patient. Its best-known applications are in oncology, where tumour profiling guides targeted therapy. Example: Testing breast-cancer patients for HER2 gene overexpression to decide whether the targeted drug trastuzumab is likely to help them.
- Genetic engineering: Genetic engineering is the direct manipulation of an organism's genes using recombinant DNA technology, most often by inserting a foreign gene to create a transgenic organism with a desired trait. It differs from conventional breeding by crossing species barriers in a single step rather than over many generations of selection. Example: Bt cotton, engineered with genes from the bacterium Bacillus thuringiensis, produces its own insecticidal protein against bollworms and is India's only commercially approved GM crop.
- Recombinant DNA technology: Recombinant DNA technology is the technique of cutting DNA from different sources and joining the fragments to create new genetic combinations. It is the foundation of genetic engineering, allowing genes to be moved between organisms or modified for desired traits. The essential tools are restriction enzymes that cut DNA at specific sites and ligases that join the fragments. Example: Human insulin for diabetes treatment is produced by inserting the human insulin gene into E. coli bacteria, which then manufacture the hormone in fermenters.
- Gene editing: Gene editing is the precise modification of an organism's DNA at targeted locations using molecular tools such as CRISPR-Cas9, TALENs and zinc-finger nucleases. Unlike older genetic engineering, which inserts foreign DNA more randomly, gene editing can add, remove or replace specific DNA sequences with high precision, and it is used in medicine, crop improvement and research. Example: Casgevy, the first CRISPR-based therapy approved in 2023, treats sickle cell disease and transfusion-dependent beta thalassaemia by editing the patient's own blood stem cells.
- CRISPR-Cas9: CRISPR-Cas9 is a gene-editing tool adapted from a natural defence system that bacteria use against viruses. A guide RNA directs the Cas9 enzyme to a precise location in DNA, where the enzyme cuts the strand, allowing scientists to delete, repair or insert genes with high accuracy. It is far cheaper, faster and more precise than earlier editing methods, which is why it won the 2020 Nobel Prize in Chemistry for Jennifer Doudna and Emmanuelle Charpentier. Example: Indian scientists are using CRISPR to develop pest-resistant and biofortified crops, and CRISPR-based therapies for sickle cell disease have entered clinical use globally.
- Gene silencing: Gene silencing is a technique that switches off or reduces the expression of a specific gene without changing the DNA sequence, most commonly through RNA interference (RNAi). It is a standard research tool for studying gene function and is also used in crop improvement to suppress genes linked to pests, diseases or undesirable traits. Example: RNA interference-based gene silencing is used in some crop varieties to suppress specific pest genes, reducing damage without chemical pesticides.
- RNA interference: RNA interference (RNAi) is a natural gene-silencing process in which small double-stranded RNA molecules, such as siRNA and miRNA, block a specific gene from producing its protein. Cells use it to defend against viruses and to regulate their own genes. The discovery of the mechanism by Andrew Fire and Craig Mello won the 2006 Nobel Prize in Physiology or Medicine. Example: Patisiran, approved in 2018, was the first RNAi-based drug, treating a rare nerve-damaging disease by silencing a faulty gene.
- transgenesis: Transgenesis is the process of introducing a gene from one organism (the transgene) into the genome of another, producing a transgenic organism that carries and expresses the foreign gene. It is the core technique of genetic engineering, used to create insect-resistant Bt cotton, vitamin-A-enriched golden rice, and therapeutic proteins in animals. Transgenic organisms are regulated in India by the Genetic Engineering Appraisal Committee (GEAC). Example: Bt cotton, which carries a gene from the bacterium Bacillus thuringiensis that makes the plant resistant to bollworm pests, is India's most widely grown transgenic crop.
- guide RNA: Guide RNA is a short synthetic RNA molecule used in CRISPR-Cas9 gene editing to steer the Cas9 enzyme to an exact location in DNA. It carries a sequence that matches the target gene, so Cas9 binds only at that spot and cuts the DNA strand there. Scientists then use the cell's repair process to disable, correct, or replace the gene. Example: Guide RNAs are designed to target the faulty beta-globin gene in CRISPR-based therapies being developed for sickle cell disease.
- Bt cotton: Cotton genetically engineered with genes from the soil bacterium Bacillus thuringiensis (Bt), producing proteins toxic to bollworm pests. Approved for commercial cultivation in India in March 2002, it now covers the overwhelming majority of India's cotton area and sharply cut bollworm pesticide use in its early years. Its later vulnerability to pink bollworm is a standard case study on pest resistance to a single toxin. Example: Bt cotton's cry proteins kill American bollworm larvae, which reduced insecticide sprays when it was first adopted.
- Golden Rice: Golden Rice is a genetically engineered variety of rice enriched with beta-carotene, a precursor of vitamin A, giving the grains their characteristic golden colour. Developed as a humanitarian project by scientists Ingo Potrykus and Peter Beyer to combat vitamin A deficiency, which causes blindness and mortality among children in developing countries, it remains one of the most debated GM crops. Example: The Philippines approved Golden Rice for commercial cultivation in 2021, becoming the first country to do so.
- Sahbhagi Dhan: Sahbhagi Dhan (breeding line IR74371-70-1-1) is a conventionally bred, drought-tolerant rice variety released in India in 2010, developed through a collaboration between the International Rice Research Institute (IRRI) and Indian institutions. It is a short-duration variety, maturing in about 105 days, that gives a yield advantage of 0.8 to 1.6 tonnes per hectare over traditional varieties in drought years, with no yield penalty under normal conditions. The same cultivar has been released in Nepal as Sukha Dhan 3 and in Bangladesh as BRRI Dhan 56. Example: During the 2012 drought, Sahbhagi Dhan yielded over a tonne per hectare more than comparable varieties in rainfed eastern India.
- monoclonal antibodies: Monoclonal antibodies are laboratory-made antibodies engineered to bind to one specific target, or epitope, on a pathogen or diseased cell. Because they are identical copies from a single cell line, they act with precision, flagging cancer cells for destruction, neutralising viruses or blocking inflammatory signals. They are among the most valuable modern biotech drugs, though their high cost limits access. Example: Trastuzumab, a monoclonal antibody targeting the HER2 protein, transformed the treatment of HER2-positive breast cancer, and antibody cocktails were used against COVID-19 before vaccines became widespread.
- xenotransplantation: Xenotransplantation is the transplantation of organs, tissues, or cells from one species to another, and is actively researched as a way to address the severe shortage of human donor organs for patients with organ failure. Pigs are the preferred source because their organs are similar in size to humans' and they can be genetically modified to reduce immune rejection, which is the main barrier to success. It remains experimental and raises ethical and biosafety questions about cross-species disease transmission. Example: In January 2022, surgeons in the United States transplanted a genetically modified pig heart into a human patient, marking a landmark first in xenotransplantation.
- Bt brinjal: A genetically modified brinjal (eggplant) developed with a Bt gene to resist the fruit-and-shoot borer pest. India's Genetic Engineering Appraisal Committee recommended it for commercial release in October 2009, but Environment Minister Jairam Ramesh imposed an indefinite moratorium in February 2010 after public consultations and protests. It remains India's cautionary precedent on GM food crops, while Bangladesh commercialised Bt brinjal in 2013. Example: The 2010 moratorium on Bt brinjal is the standard UPSC example of the precautionary principle in GM regulation.
- SDN-1 and SDN-2: SDN-1 and SDN-2 are the first two categories of site-directed nuclease (SDN) genome-editing outcomes in plants. In SDN-1, a targeted nuclease such as CRISPR-Cas9 creates a DNA break that the cell repairs on its own, producing small insertions or deletions; in SDN-2, a short repair template guides the cell to make precise small changes. Neither introduces foreign DNA, so the edited plants are treated differently from transgenic GMOs. In 2022 India exempted SDN-1 and SDN-2 genome-edited plants from the strictest biosafety regulations that apply to GM crops. Example: The 2022 exemption of SDN-1 and SDN-2 edits from full GM-crop regulation in India.
- Gene therapy: Gene therapy is a medical treatment that introduces, replaces or repairs genes in a patient's cells to treat or prevent disease, typically using a modified virus as a delivery vector. It is used mainly for inherited genetic disorders where a faulty gene can be corrected or compensated with a working copy. Example: Luxturna, a gene therapy for an inherited retinal disorder, delivers a working copy of the RPE65 gene to restore vision.
- monogenic disorders: Monogenic disorders are diseases caused by a mutation in a single gene, following predictable inheritance patterns. Because only one faulty gene is involved, they are the most tractable targets for gene therapy: correcting or replacing that one gene can potentially cure the disease. Classic examples include sickle cell anaemia, beta-thalassemia, cystic fibrosis and haemophilia. Example: Sickle cell anaemia, common among tribal populations in central India, is a monogenic disorder caused by a single mutation in the haemoglobin gene, and India's National Sickle Cell Anaemia Elimination Mission aims to eliminate it by 2047.
- haemophilia A: Haemophilia A is an inherited bleeding disorder in which the blood cannot clot properly because of a shortage of clotting factor VIII. It is caused by a mutation in the F8 gene on the X chromosome, so it mainly affects males while females are usually carriers. People with the condition bleed for longer after injuries and can suffer spontaneous internal bleeding into joints and muscles. Example: Patients are treated with infusions of clotting factor VIII to prevent or stop bleeding episodes.
- Factor VIII: Factor VIII is a blood clotting protein whose deficiency causes haemophilia A, a bleeding disorder in which blood does not clot normally. Patients receive replacement therapy with Factor VIII concentrates, which are now produced through genetic engineering by expressing the human gene in cultured cells. Recombinant Factor VIII is a classic example of a therapeutic protein made possible by biotechnology. Example: Haemophilia A patients receive recombinant Factor VIII infusions to restore normal blood clotting.
- Christian Medical College (CMC) Vellore: Christian Medical College Vellore is a private, nonprofit, Christian minority-run medical college and hospital in Vellore, Tamil Nadu. Founded in 1900 by the American missionary Dr Ida S. Scudder, it grew from a one-bed clinic into one of India's leading teaching hospitals and research institutions. It is known for a series of Indian medical firsts, including the country's first College of Nursing (1946), first successful open-heart surgery (1961), first kidney transplant (1971) and first bone marrow transplant (1986). Example: CMC Vellore performed India's first successful open-heart surgery in 1961, setting the benchmark for cardiac care in the country.
- lentiviral vector: A lentiviral vector is a delivery vehicle made from a modified lentivirus (a family of viruses that includes HIV) whose disease-causing genes have been removed, used to carry new genetic material into a patient's cells. Because it can insert its cargo into the genome of both dividing and non-dividing cells and keep it expressed long-term, it is the workhorse of ex vivo gene therapies. Safety-engineered versions that cannot replicate are now standard in clinical gene therapy. Example: In CAR-T cell therapy, a lentiviral vector is used in the laboratory to insert the chimeric antigen receptor gene into a patient's own T-cells, reprogramming them to hunt cancer cells.
- CAR-T cell therapy: A cancer immunotherapy in which a patient's own T-cells are collected, genetically engineered in the laboratory to carry chimeric antigen receptors that recognise cancer cells, and infused back into the patient. It has produced striking remissions in blood cancers such as B-cell leukaemia and lymphoma that resist chemotherapy. India's first indigenous CAR-T therapy, NexCAR19, was launched in 2024 at a fraction of imported treatment costs. Example: NexCAR19, developed by ImmunoACT with IIT Bombay and Tata Memorial Centre, targets the CD19 protein on cancerous B-cells.
- Chimeric Antigen Receptor T-cell therapy: Chimeric Antigen Receptor (CAR) T-cell therapy is a form of cancer immunotherapy in which a patient's own T-cells are collected, genetically engineered in a laboratory to carry receptors that recognise cancer cells, and infused back into the patient. These supercharged T-cells hunt down and destroy the targeted cancer. It has shown remarkable results in blood cancers like acute lymphoblastic leukaemia and certain lymphomas, though it is very expensive and can cause severe side effects such as cytokine release syndrome. Example: India's first indigenous CAR T-cell therapy, NexCAR19 (developed by IIT Bombay, Tata Memorial Centre and ImmunoACT), was approved in 2023 and costs a fraction of imported therapies.
- living drug: A living drug is a therapy made of living cells that have been taken from the patient, genetically modified in a laboratory and infused back to fight disease. Unlike chemical drugs that are manufactured and metabolised, living drugs persist in the body, multiply and adapt, acting as an intelligent, self-replicating medicine. CAR-T cell therapy for blood cancers is the flagship example, though such personalised cell therapies remain extremely expensive. Example: In CAR-T therapy, a patient's own T-cells are reprogrammed with a cancer-hunting receptor and infused back, where they expand inside the body and attack leukaemia or lymphoma cells for months or years.
- T-cells: T-cells are a type of white blood cell, or lymphocyte, that are central to the adaptive immune response. They mature in the thymus and include helper T-cells that coordinate immunity and cytotoxic T-cells that kill infected or cancerous cells. Engineered T-cells are the basis of modern immunotherapies such as CAR-T cell therapy for blood cancers. Example: CAR-T therapy engineers a patient's own T-cells to recognise and destroy cancer cells.
- leukapheresis: Leukapheresis is a medical procedure in which blood is drawn from a patient, passed through a machine that separates out white blood cells (leukocytes), and the remaining blood is returned to the body. It is the essential first step of CAR-T cell therapy, where the collected T-cells are sent to a laboratory for genetic modification and multiplication before being infused back. The procedure is similar to blood donation and is also used to treat conditions with dangerously high white cell counts. Example: A cancer patient undergoing CAR-T therapy first sits through a few hours of leukapheresis to harvest the T-cells that will later be genetically reprogrammed and returned as a living drug.
- NexCAR19: India's first indigenously developed CAR-T cell therapy, a personalised cancer treatment in which a patient's own T cells are genetically engineered to express a chimeric antigen receptor targeting the CD19 protein on cancerous B cells. Developed by ImmunoACT, an IIT Bombay-incubated company, with Tata Memorial Centre, it received CDSCO market authorisation in October 2023 for relapsed or refractory B-cell lymphomas and leukaemia, at roughly one-tenth the cost of imported CAR-T therapies. Example: Priced at about Rs 30 lakh to Rs 40 lakh per patient against Rs 3 crore to Rs 4 crore abroad, it showed a 70 per cent overall response rate in its 60-patient pivotal trial.
- ImmunoACT: ImmunoACT is an Indian biotechnology company incubated at IIT Bombay that developed NexCAR19, India's first indigenously developed CAR-T cell therapy for blood cancers. In October 2023 the CDSCO granted it market authorisation for relapsed or refractory B-cell lymphoma and B-cell acute lymphoblastic leukaemia in patients aged 15 and above, after trials in 60 patients showed about a 70 per cent overall response rate. Example: NexCAR19, developed by ImmunoACT in collaboration with Tata Memorial Hospital, is India's first home-grown CAR-T therapy.
- Tata Memorial Hospital: Tata Memorial Hospital in Mumbai, founded in 1941 and now under the Department of Atomic Energy, is India's premier cancer treatment and research centre. It provides affordable cancer care to lakhs of patients, runs the Advanced Centre for Treatment, Research and Education in Cancer, and maintains one of the country's most important cancer registries. Example: Its hospital-based cancer registry is a key source of data on cancer trends in India.
- CD19: A protein found on the surface of B-cells, the immune cells that turn cancerous in B-cell leukaemias and lymphomas. Because it is present on both healthy and malignant B-cells, it is the standard target for CAR-T cell therapies: engineered T-cells lock onto CD19 and destroy the cells carrying it. The on-target destruction of healthy B-cells is a known side effect of the treatment. Example: India's NexCAR19 therapy works by directing engineered T-cells against the CD19 marker on cancerous B-cells.
- Qartemi: Qartemi is the brand name of varnimcabtagene autoleucel (IMN-003A), a CAR T-cell therapy developed by the Bengaluru-based Immuneel Therapeutics. Approved by the Central Drugs Standard Control Organisation in January 2025, it is India's second approved CAR T-cell therapy after NexCAR19, indicated for adult patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma. It is a personalized living drug made by genetically engineering the patient's own T cells to attack cancer cells, and is priced at roughly one-tenth of comparable products in the United States. Example: Its launch in January 2025 as a treatment option for Indian adults with relapsed B-cell Non-Hodgkin Lymphoma
- neurological toxicity: Neurological toxicity, or neurotoxicity, is damage to the brain, spinal cord, or peripheral nerves caused by exposure to a chemical, drug, or biological agent. In biosafety regulation, new genetically modified crops and biotechnology products are screened for neurotoxic effects as part of their toxicity assessment before approval. Symptoms in humans can range from headaches and tremors to cognitive impairment, depending on dose and duration. Example: Chronic lead exposure in children, which impairs brain development and lowers cognitive ability.
- on-target, off-tumor effect: In targeted cancer therapies such as CAR-T cell therapy, the on-target, off-tumor effect occurs when the treatment correctly binds its intended molecular target, but that target is also present on healthy cells, so healthy tissue is destroyed as well. It is a key toxicity challenge, distinct from off-target effects where the drug binds the wrong molecule entirely. Managing it requires choosing antigens that are as tumour-specific as possible. Example: CAR-T cells aimed at the CD19 protein on leukaemia cells also wipe out healthy CD19-bearing B-cells, causing prolonged B-cell loss in patients.
- antigen escape: Antigen escape is the mechanism by which cancer cells or pathogens evade an immune attack by reducing or losing the surface antigen that the immune system or a therapy is targeting. It is a major reason targeted immunotherapies fail: under selective pressure, tumour subclones that shed the target protein survive and cause relapse. The concept also applies to microbes that mutate their surface proteins to escape vaccines or antibodies. Example: Some leukaemia patients relapse after CAR-T therapy because their cancer cells stop expressing the CD19 protein the CAR-T cells were engineered to attack.
- allogeneic: Allogeneic describes biological material, such as stem cells, tissues or transplanted organs, taken from a genetically different donor of the same species. It is the opposite of autologous, where the material comes from the patient's own body. Allogeneic therapies offer off-the-shelf availability but carry risks of immune rejection and graft-versus-host disease, so donor-recipient matching and immunosuppression matter. Example: An allogeneic bone marrow transplant from a matched sibling donor is a standard cure for several blood cancers and thalassemia.
- National Biopharma Mission: The National Biopharma Mission is an industry-academia mission of the Department of Biotechnology, launched in 2017 with World Bank assistance and branded as Innovate in India (i3). It aims to make India a hub for affordable biopharmaceuticals and medical devices by strengthening clinical trial capacity, product development and shared research infrastructure. It addresses the gap between academic research and commercial products in vaccines, biologics and medical devices. Example: The mission built shared clinical-trial infrastructure that indigenous vaccine developers can use for trials.
- BioE3 Policy: The BioE3 Policy, short for Biotechnology for Economy, Environment and Employment, was approved by the Union Cabinet in August 2024 to foster high-performance biomanufacturing in India. It provides innovation-driven support for research, development and entrepreneurship across six thematic areas, including bio-based chemicals, precision biotherapeutics, climate-resilient agriculture and carbon capture. The policy aims to grow India's bioeconomy from over 130 billion US dollars in 2024 toward 300 billion dollars by 2030, supporting net-zero and green growth goals. Example: Under BioE3, the government is establishing biomanufacturing facilities, bio-AI hubs and biofoundries to take biotech innovations from lab to market.
- Biotechnology for Economy, Environment and Employment: Approved by the Union Cabinet on 24 August 2024 and formulated by the Department of Biotechnology, BioE3 is India's policy for fostering high-performance biomanufacturing. It converges biotechnology with engineering and digital tools across five priority domains: carbon capture and utilisation, precision biotherapeutics, smart proteins, enzymes and climate-resilient agriculture. A MoolankurBioEnabler Network of Bio-AI hubs, biofoundries and biomanufacturing centres supports the mission of green growth, employment generation and bioeconomic expansion. Example: The first DBT-BIRAC joint call under BioE3 drew over 2,000 proposals, with about 40 percent led by startups and industry.
- high-performance biomanufacturing: High-performance biomanufacturing is the large-scale production of goods using biological systems, such as engineered microbes, enzymes, and cell cultures, with advanced precision and efficiency. It covers bio-based chemicals, enzymes, bioplastics, biofuels, and biopharmaceuticals, replacing polluting chemical processes with cleaner biological ones. India has made it a national priority as a route to becoming a global biomanufacturing hub. Example: The BioE3 (Biotechnology for Economy, Environment and Employment) Policy, approved by the Union Cabinet in August 2024, is built around fostering high-performance biomanufacturing.
- Bio-RIDE: Bio-RIDE (Biotechnology Research Innovation and Entrepreneurship Development) is the consolidated umbrella scheme of the Department of Biotechnology, formed by merging two earlier DBT schemes and adding a new component on biomanufacturing and biofoundry. Approved by the Union Cabinet in 2025, it funds research, innovation and entrepreneurship across biotechnology while specifically supporting the high-performance biomanufacturing goals of the BioE3 policy. It represents the main implementation vehicle for translating biotech research into industrial products. Example: The Department of Biotechnology and BIRAC issued a joint call for proposals to establish Bio-AI 'moolankur' hubs under Bio-RIDE and the BioE3 policy.
- Bio-AI hubs: Bio-AI hubs are research centres established under India's BioE3 policy and its Bio-RIDE scheme to combine artificial intelligence with biology for solving complex biological challenges. They bring together multidisciplinary teams from academia and industry to work on data-driven research in areas such as biomolecular design, sustainable agriculture, synthetic biology, Ayurveda and genome diagnostics. The hubs are meant to bridge the gap between laboratory research and market-ready biomanufacturing. Example: Under the BioE3 policy, Bio-AI 'moolankur' hubs were announced to apply AI to challenges in health, agriculture and environment.
- Key takeaways: Key takeaways is a quick-revision summary box placed at the end of each article, listing the most exam-relevant points in a short numbered list. It distils definitions, dates, figures, provisions and examples into a form suited for last-minute revision before Prelims and Mains. Together with the article's practice questions, it turns every topic into a self-contained study unit.
- Way forward: In UPSC mains answers, essays and policy discussions, the way forward is the concluding section that moves from analysis to concrete, actionable recommendations for solving the problem discussed. A strong way forward is specific and implementable, naming institutions, reforms, technologies or timelines, rather than repeating generic calls for awareness. Examiners reward answers that end with a realistic, multi stakeholder roadmap instead of stopping at criticism. Example: A way forward on urban flooding could propose sponge city designs, strict protection of wetlands as natural sponges, and real time flood warning systems run by municipal corporations.
- Department of Biotechnology (DBT): The Department of Biotechnology (DBT) is the department under India's Ministry of Science and Technology responsible for promoting biotechnology research, industry and translation. It funds research institutions, biotech parks and startups, and runs missions on biopharma, biofuels and genomics, while biosafety approvals for genetically modified organisms go through the Genetic Engineering Appraisal Committee (GEAC) under the Environment Ministry. DBT is the government's main vehicle for turning India's life-sciences research into industrial and public-health outcomes. Example: DBT anchored the National Biopharma Mission, which backed indigenous vaccine and biotherapeutic development.
- Indian Biological Data Centre (IBDC): India's first national repository for life science data, dedicated to the nation on 10 November 2022 and housed at the Regional Centre of Biotechnology (RCB), Faridabad, with support from the Department of Biotechnology and a disaster recovery site at the National Informatics Centre, Bhubaneswar. Under the Biotech-PRIDE guidelines it archives life science data generated from publicly funded research in India, with about 4 petabytes of storage and the Brahm high-performance computing facility. Example: IBDC hosts the Indian Nucleotide Data Archive (INDA) and an online dashboard for genomic surveillance data generated by the INSACOG laboratories.
- Genetic Engineering Appraisal Committee (GEAC): The Genetic Engineering Appraisal Committee (GEAC) is the apex statutory body under the Environment (Protection) Act, 1986, functioning under the Ministry of Environment, Forest and Climate Change. It appraises and approves activities involving genetically modified organisms, including field trials, environmental release and import or export of GM material. It was earlier called the Genetic Engineering Approval Committee and was renamed in 2010. Example: GEAC cleared Bt brinjal for environmental release in 2009, after which the government placed it under a moratorium in 2010.
- Dhara Mustard Hybrid-11 (DMH-11): Dhara Mustard Hybrid-11 (DMH-11) is India's first transgenic mustard hybrid, developed at the Centre for Genetic Manipulation of Crop Plants (CGMCP), University of Delhi, by the team of Deepak Pental. It is a cross between the Indian variety Varuna and the East European Early Heera-2, using the barnase-barstar gene system (genes from the soil bacterium Bacillus amyloliquefaciens) to create male sterility in one parent and restore fertility in the hybrid. In October 2022 the Genetic Engineering Appraisal Committee (GEAC) approved its environmental release, making it the first genetically modified food crop cleared in India (Bt cotton, the only earlier clearance, is a non-food crop). Example: ICAR-supervised field trials reported DMH-11 yielding about 28 percent more than its parent variety Varuna.
- Central Drugs Standard Control Organisation (CDSCO): The Central Drugs Standard Control Organisation (CDSCO) is India's national drug regulator, functioning under the Directorate General of Health Services in the Ministry of Health and Family Welfare. Headed by the Drugs Controller General of India (DCGI), it approves new drugs and clinical trials, regulates drug imports, and lays down standards for drugs, cosmetics and medical devices under the Drugs and Cosmetics Act, 1940. State drug controllers handle manufacturing licences while CDSCO handles central approvals. Example: CDSCO granted emergency use authorisation to COVAXIN and Covishield during the COVID-19 pandemic in January 2021.
- Cytokine release syndrome (CRS): Cytokine release syndrome (CRS) is a systemic inflammatory response caused by the rapid release of large quantities of cytokines, the signalling proteins of the immune system. It is most famously a side effect of immunotherapies such as CAR-T cell therapy and certain monoclonal antibodies, where activated immune cells flood the body with cytokines. Symptoms range from high fever and fatigue to dangerously low blood pressure and organ failure, and severe cases are managed with the anti-IL-6 drug tocilizumab and corticosteroids. Example: CRS is the best-known serious side effect of CAR-T cell therapies for blood cancers, including India's indigenously developed NexCAR19 therapy launched in 2023.
- Biotechnology Industry Research Assistance Council (BIRAC): The Biotechnology Industry Research Assistance Council (BIRAC) is a public sector company under the Department of Biotechnology, established in 2012 to support biotechnology innovation and entrepreneurship in India. It funds startups, small companies and academic researchers through grants, incubation support and equity-free schemes, bridging the gap between research and commercialisation. It plays a central role in implementing programmes under the BioE3 policy and the Bio-RIDE scheme. Example: BIRAC's Biotechnology Ignition Grant (BIG) scheme provides early-stage funding to biotech startups developing new products.
- National Biotechnology Development Strategy (2020-25): The National Biotechnology Development Strategy 2020-2025 is the Department of Biotechnology's roadmap for growing India's bioeconomy through research, innovation and skilled manpower. It targets areas such as affordable healthcare, agriculture, food security and environmental biotechnology, alongside infrastructure like biotech parks and clusters. The strategy set the goal of positioning India among the world's leading biotechnology ecosystems by the end of its term. Example: Biotech clusters such as the Bengaluru Helix Biotech Park grew under its umbrella.
- 3D bioprinting: 3D bioprinting is an additive manufacturing technique that builds three-dimensional biological structures layer by layer, depositing bio-inks, printable mixtures of living cells in supportive biomaterials, through a computer-controlled nozzle following a digital blueprint. Its current applications are tissue scaffolds, drug-testing models and research into organ printing; fully transplantable printed organs do not yet exist, mainly because of the unsolved problem of vascularisation.
- bio-ink: A bio-ink is the printable material used in 3D bioprinting: living cells suspended in a supportive biomaterial, usually a hydrogel, formulated to flow through a printer nozzle and then hold its shape. A good bio-ink must be printable, biocompatible, and able to keep cells alive and functioning after printing.
- hydrogel: A hydrogel is a water-swollen network of polymer chains that mimics the soft, wet environment cells inhabit inside the body. In 3D bioprinting, hydrogels are the standard carrier material in bio-inks, giving printed constructs their structure while letting nutrients diffuse to the embedded cells.
- extrusion bioprinting: Extrusion bioprinting is the most common 3D bioprinting method, in which bio-ink is pushed continuously through a nozzle, like toothpaste from a tube, to lay down filaments layer by layer. It handles the densest cell loads and the widest range of viscous bio-inks, at the cost of lower resolution than inkjet or laser-assisted methods.
- bioreactor: A bioreactor is a vessel that provides the controlled environment cells need to grow outside the body: nutrients, oxygen, temperature, and sometimes mechanical cues like stretching or fluid flow. In 3D bioprinting, the printed construct matures in a bioreactor while its cells multiply, fuse and begin behaving like real tissue.
- vascularisation: Vascularisation is the formation of blood vessels within a tissue. It is the central unsolved problem of 3D bioprinting: without a vessel network, any printed tissue thicker than a few millimetres starves at its core because nutrients cannot diffuse that far, which is why full printed organs for transplant remain out of reach.
- autologous sourcing: Autologous sourcing means obtaining cells from the patient's own body for a medical procedure. In 3D bioprinting it is the ethically cleanest cell source, since tissue printed from a patient's own cells sidesteps immune rejection and avoids the consent controversies around donor or embryonic stem-cell lines.
- Bollgard I: Bt cotton carrying the cry1Ac gene alone; India's first approved Bt cotton.
- Bollgard II: Bt cotton carrying cry1Ac plus cry2Ab; broader bollworm protection and slower pest-resistance build-up.
- cry1Ac: Bt gene whose protein toxin kills bollworm and shoot-borer larvae; present in Bollgard I cotton and Bt brinjal.
- cry2Ab: second Bt gene added in Bollgard II cotton alongside cry1Ac to widen protection and delay resistance.
- DMH-11: genetically modified mustard using the barnase-barstar system for hybrid seed production; regulatory clearance contested.
- Bt brinjal: cry1Ac brinjal resistant to the fruit and shoot borer; commercial release under moratorium since 2010.
- MON 863: a Monsanto GM maize variety at the centre of an allergenicity and toxicity controversy over rat-feeding studies.
- Golden rice: rice engineered to make beta-carotene (provitamin A) in the endosperm to combat vitamin A deficiency.
- uncbd: The United Nations Convention on Biological Diversity (UNCBD) defines biotechnology as 'any technological application that utilizes biological systems, living organisms, or their derivatives to create or modify products and processes for specific purposes.'
- gene drive: A gene drive is a genetic system engineered to spread a chosen set of genes rapidly through a wild population by biasing inheritance so that nearly all offspring carry the trait. Researchers propose gene drives to suppress malaria-transmitting mosquitoes; ecologists warn that an accidental release could be irreversible.
- synthetic biology: Synthetic biology is the redesign of existing biological organisms and the construction of entirely new forms of life, applying engineering principles to DNA to manufacture medicines, materials and fuels.
- somatic cell nuclear transfer (scnt): Somatic cell nuclear transfer (SCNT) is a cloning technique in which the nucleus of a somatic (body) cell is transferred into an egg cell whose own nucleus has been removed. The egg is then stimulated to divide into an embryo genetically identical to the nucleus donor.
- gene gun: A gene gun is a device used in plant genetic engineering that fires microscopic heavy-metal particles coated with a gene of interest into plant cells with mechanical force, where the gene integrates into the genome.
- agrobacterium-mediated transformation: Agrobacterium-mediated transformation is a method of creating transgenic plants that uses the soil bacterium Agrobacterium tumefaciens, which naturally transfers part of its own DNA into plant cells, to carry a gene of interest into the plant genome.
- flavr savr: The Flavr Savr tomato was the first commercially grown genetically engineered food, licensed for human consumption in the United States in 1994. It carried an antisense gene that slowed softening by suppressing the polygalacturonase enzyme, extending shelf life.
- review committee on genetic manipulation (rcgm): The Review Committee on Genetic Manipulation (RCGM), functioning under the Department of Biotechnology, monitors research and development activities involving genetically modified organisms in India.
- birsa-101: BIRSA-101 is India's first indigenous CRISPR-based gene therapy for sickle cell disease, unveiled in November 2025 at CSIR-IGIB Delhi on the home-grown enFnCas9 platform, with technology transferred to the Serum Institute of India for affordable scale-up.
- indigau: IndiGau is India's first cattle genomic chip, a single-nucleotide-polymorphism (SNP) chip carrying 11,496 markers, developed by the National Institute of Animal Biotechnology (NIAB), Hyderabad and released in August 2021 to conserve indigenous cattle breeds such as Gir, Sahiwal, Kankrej and Ongole.
- rashtriya gokul mission: The Rashtriya Gokul Mission, launched in 2014, works on the conservation and genetic upgradation of indigenous cattle breeds through artificial insemination, IVF, progeny testing and bull production.
- satat: SATAT (Sustainable Alternative Towards Affordable Transportation) is a Government of India initiative that promotes compressed bio-CNG produced from agricultural residue, cattle dung and municipal solid waste as an automotive and industrial fuel.
- gobar-dhan: GOBARdhan (Galvanizing Organic Bio-Agro Resources Dhan) is a Government of India scheme that converts cattle dung and farm waste into biogas, compressed biogas and bio-fertilisers, supporting rural energy security.
- dolly the sheep: Dolly the sheep, born in 1996, was the first mammal cloned from an adult somatic cell using somatic cell nuclear transfer, proving that a specialised cell's nucleus retains the full genetic programme to build a whole animal.
- zinc finger nucleases (zfns): Zinc finger nucleases (ZFNs) are gene-editing tools made of engineered proteins that bind specific DNA triplets, fused to a DNA-cutting enzyme that cuts the genome at the bound site. They preceded CRISPR but are costlier and harder to design.
- talens: TALENs (transcription activator-like effector nucleases) are gene-editing tools built from engineered proteins that read DNA one base at a time, fused to a cutting enzyme. They are more flexible than ZFNs but bulkier to construct.
- e20: E20 denotes petrol blended with 20 percent ethanol, a biofuel target India advanced to 2025 under its ethanol blending programme, with second-generation ethanol made from agricultural residue such as paddy straw.
Prelims practice
With reference to the Genome India Project, consider the following statements:
1. It is funded and coordinated by the Department of Biotechnology.
2. It aims to sequence the whole genomes of 10,000 individuals representing India's diverse population.
3. The sequenced data is archived at the Indian Biological Data Centre, Faridabad.
Show answer
Answer: (D) All three statements are correct: DBT funds and coordinates the project, the target is 10,000 genomes, and IBDC Faridabad archives the data.
The CRISPR-Cas9 system used in gene editing is derived from:
Show answer
Answer: (B) CRISPR-Cas9 repurposes the bacterial immune system, in which Cas9 cuts viral DNA guided by stored RNA snippets.
With reference to NexCAR19, consider the following statements:
1. It is India's first indigenously developed CAR-T cell therapy.
2. It targets the CD19 protein on cancerous B-cells.
3. It is primarily used for treating solid tumours.
Show answer
Answer: (A) Statements 1 and 2 are correct; NexCAR19 targets blood cancers (B-cell lymphoma and leukaemia), not solid tumours.
The BioE3 Policy, approved in 2024, stands for:
Show answer
Answer: (A) BioE3 stands for Biotechnology for Economy, Environment and Employment, focused on high-performance biomanufacturing.
With reference to India's first human gene therapy trial for haemophilia A, consider the following statements:
1. It was conducted at the Christian Medical College, Vellore.
2. It used a lentiviral vector to insert a working Factor VIII gene into patients' own blood-forming stem cells.
3. All five enrolled participants reported zero annualised bleeding rates.
Show answer
Answer: (D) All three statements are correct: the CMC Vellore trial used a lentiviral vector for Factor VIII delivery in five participants with zero bleeding episodes.
Answer key
- (d): All three statements are correct: DBT funds and coordinates the project, the target is 10,000 genomes, and IBDC Faridabad archives the data.
- (b): CRISPR-Cas9 repurposes the bacterial immune system, in which Cas9 cuts viral DNA guided by stored RNA snippets.
- (a): Statements 1 and 2 are correct; NexCAR19 targets blood cancers (B-cell lymphoma and leukaemia), not solid tumours.
- (a): BioE3 stands for Biotechnology for Economy, Environment and Employment, focused on high-performance biomanufacturing.
- (d): All three statements are correct: the CMC Vellore trial used a lentiviral vector for Factor VIII delivery in five participants with zero bleeding episodes.
Mains Practice question
150 words: The Genome India Project is a prerequisite for precision medicine in India. Discuss.
- Define and locate: DBT-funded project (January 2020), 10,000 Indian whole genomes sequenced by 2024, data at IBDC Faridabad, findings in Nature Genetics (April 2025).
- Why prerequisite: Western reference databases under-represent Indian diversity; precision medicine needs population-specific variant catalogues (example: MYBPC3 in 4 percent of Indians).
- Applications: pharmacogenomics, disease-risk prediction, affordable genome-wide arrays for diagnostics, Phase II disease comparisons.
- Caveats: data privacy and consent, equitable access to precision therapies, need for clinician and counsellor capacity.
250 words: Gene editing technologies such as CRISPR-Cas9 raise profound ethical and regulatory questions. Examine with reference to India's framework.
- The technology: programmable editing via guide RNA and Cas9; somatic vs germline edits; therapeutic vs enhancement uses.
- Ethical concerns: heritable changes, designer babies, equity of access, ecological release of edited organisms, consent.
- India's framework: GEAC as apex regulator; Bt brinjal moratorium (2010) as cautionary precedent; DMH-11 clearance (2022) with judicial scrutiny; 2022 exemption for SDN-1/SDN-2 edits without foreign DNA.
- Way forward: risk-proportionate regulation, transparent public consultation, ethics review for clinical applications, global harmonisation.
150 words: Discuss the significance of the indigenous CAR-T therapy NexCAR19 for cancer care in India.
- The milestone: first indigenous CAR-T, CDSCO approval October 2023, IIT Bombay plus Tata Memorial plus ImmunoACT, launched April 2024.
- Significance: cost of Rs 30-40 lakh vs Rs 3-4 crore abroad (frugal innovation), Atmanirbhar Bharat in advanced therapy, living-drug platform for future cell therapies.
- Limits: blood cancers only so far, CRS and neurotoxicity risks, antigen escape, personalised manufacturing bottlenecks; Qartemi (2025) shows ecosystem deepening.
Asked in the mains
Previous-year questions from this topic
How UPSC has actually asked this topic — with the year and marks for each question.
- 201815 marks
Why is there so much activity in the field of biotechnology in our country? How has this activity benefitted the field of biopharma?
- 201915 marks
How can biotechnology improve the living standards of farmers?
- 202115 marks
What are the research and developmental achievements in applied biotechnology? How will these achievements help to uplift the poor sections of the society?
- 202210 marks
Each year a large amount of plant material, cellulose, is deposited on the surface of Planet Earth. What are the natural processes this cellulose undergoes before yielding carbon dioxide, water and other end products?
Asked in the prelims
Previous-year MCQs from this topic
How UPSC has tested this topic in the prelims — pick an option to test yourself.
- 2026Prelims
1.Which of the following statements with regard to genetic medicine is/are correct? 1. Genetic medicines correct/compensate for the faulty genes responsible for disease. 2. Engineered viruses and lipid nanoparticles are used as carriers of the genetic medicine. 3. Genetic medicines alter the entire DNA sequence.
- 2026Prelims
2.Which of the following statements with regard to Genome India Project is/are correct? 1. It is a part of the Human Genome Project. 2. The project is funded by the Department of Biotechnology (DBT), Government of India. 3. Its primary aim is to build a catalogue of genetic diversity of the Indian population.
- 2020Prelims
3.Consider the following statements: (1) Genetic changes can be introduced in the cells that produce eggs or sperms of a prospective parent. (2) A person’s genome can be edited before birth at the early embryonic stage. (3) Human induced pluripotent stem cells can be injected into the embryo of a pig. Which of the statements given above is/ are correct?
- 2019Prelims
4.What is Cas9 protein that is often mentioned in news?
- 2019Prelims
5.With reference to the recent developments in science, which one of the following statements is not correct?
- 2019Prelims
6.RNA interference (RNAi)’ technology has gained popularity in the last few years. Why? 1. It is used in developing gene silencing therapies. 2. It can be used in developing therapies for-the treatment of cancer. 3. It can be used to develop hormone replacement therapies. 4. It can be used to produce crop plants that are resistant to viral pathogens. Select the correct answer using the code given below.
- 2017Prelims
7.With reference to agriculture in India, how can the technique of `genome sequencing’, often seen in the news, be used in the immediate future? 1. Genome sequencing can be used to identify genetic markers far disease resistance and drought tolerance in various crop plants. 2. This technique helps in reducing the time required to develop new varieties of crop plants. 3. It can be used to decipher the host-pathogen relationships in crops. Select the correct- answer using the code given below:
- 2013Prelims
8.Recombinant DNA technology (Genetic Engineering) allows genes to be transferred (1). across different species of plants (2). from animals to plants (3). from microorganisms to higher organisms Select the correct answer using the codes given below.
- 2011Prelims
9.At present, scientists can determine the arrangement or relative positions of genes or DNA sequences on a chromosome. How does this knowledge benefit us? 1. It is possible to know the pedigree of livestock. 2. It is possible to understand the causes of all human diseases. 3. It is possible to develop disease-resistant animal breeds.
- 2014Prelims
10.Consider the following techniques/ phenomena: 1. Budding and grafting in fruit plants 2. Cytoplasmic male sterility 3. Gene silencing Which of the above is/are used to create transgenic crops?
- 2018Prelims
11.Consider the following pairs : Terms sometimes seen in news Context /Topic Belle II experiment Artificial Intelligence Blockchain technology Digital/ Cryptocurrency CRISPR — Cas9 Particle Physics Which of the pairs given above is/are correctly matched?
- 2021Prelims
12.“Bollgard I and Bollgard II technologies are mentioned in the context of:
- 2018Prelims
13.With reference to the Genetically Modified mustard (GM mustard) developed in India, consider the following statements : 1.GM mustard has the genes of a soil bacterium that give the plant the property of pest-resistance to a wide variety of pests. 2.GM mustard has the genes that allow the plant cross-pollination and hybridization. 3.GM mustard has been developed jointly by the IARI and Punjab Agricultural University. Which of the statements given above is/are correct ?
- 2012Prelims
14.Other than resistance to pests, what are the prospects for which genetically engineered plants have been created? 1. To enable them to withstand drought 2. To increase the nutritive value of the produce 3. To enable them to grow and do photosynthesis in spaceships and space stations 4. To increase their shelf life.
- 2012Prelims
15.What are the reasons for the people’s resistance to the introduction of BT brinjal in India? 1. Bt brinjal has been created by inserting a gene from a soil fungus into its genome. 2. The seeds of Bt brinjal are terminator seeds and therefore, the farmers have to buy the seeds before every season from the seed companies. 3. There is an apprehension that the consumption of Bt brinjal may have adverse impact on health. 4. There is some concern that the introduction of BT brinjal may have adverse effect on the biodiversity. Select the correct answer using the code given below:
- 2011Prelims
16.A genetically engineered form of brinjal, known as the Bt-Brinjal, has been developed. The objective of this is
- 2010Prelims
17.Mon 863 is a variety of maize. It was in the news for the following reason
- 2010Prelims
18.Genetically modified “golden rice” has been engineered to meet human nutritional requirements. Which one of the following statements best qualifies golden rice?