Biotech & health

Biotechnology applies cellular, molecular, and genetic techniques—recombinant DNA, gene editing, monoclonal antibodies, and synthetic biology—to develop therapeutics, vaccines, diagnostics, and engineered crops. In India the sector is steered by the Department of Biotechnology (DBT), established in 1986 under the Ministry of Science and Technology, and its public-sector arm the Biotechnology Industry Research Assistance Council (BIRAC), set up in 2012 to support startups. The BioE3 Policy (Biotechnology for Economy, Environment and Employment), approved by the Union Cabinet in August 2024, anchors the current strategy, targeting high-performance biomanufacturing, biofoundries, and a projected USD 300 billion bioeconomy by 2030. Regulatory authority over genetically modified organisms rests with the Genetic Engineering Appraisal Committee (GEAC) under the Environment (Protection) Act, 1986 and the 1989 Rules, while drugs and vaccines fall under the Drugs and Cosmetics Act, 1940 administered by the Central Drugs Standard Control Organisation (CDSCO) and the Drugs Controller General of India (DCGI).

The architecture works through tiered approval and institutional support. Field trials of GM crops require GEAC clearance; the Recombinant DNA Advisory Committee (RDAC) and the Review Committee on Genetic Manipulation (RCGM) provide scientific vetting. Health-sector delivery operates through the Indian Council of Medical Research (ICMR) for clinical research ethics, the National Pharmaceutical Pricing Authority (NPPA) for drug price control under the Drugs Prices Control Order, and Ayushman Bharat–PM-JAY for insurance coverage. The Mission COVID Suraksha financed indigenous vaccines, and the National Biopharma Mission (Innovate in India), launched in 2017 with World Bank support, built end-to-end product development capacity. Gene-edited crops using SDN-1 and SDN-2 techniques were exempted from stringent GEAC review by a 2022 DBT notification, distinguishing them from transgenic GMOs.

Named milestones illustrate the field: Bt cotton, the only GM crop commercially cultivated in India, approved by GEAC in 2002; GM mustard (DMH-11), granted environmental release approval in October 2022 though litigated before the Supreme Court, which delivered a split verdict in July 2024 and referred the matter; Covaxin (BBV152), India's first indigenous COVID-19 vaccine developed by Bharat Biotech with ICMR–NIV; and the DNA vaccine ZyCoV-D by Zydus, the world's first approved plasmid DNA COVID vaccine (2021). India's gene therapy for cancer, NexCAR19 (CAR-T cell therapy), received CDSCO approval in 2023, the first such indigenous approval in a developing country. As of 2026 the Anti-Microbial Resistance action plan and the One Health framework integrating human, animal, and environmental health remain policy priorities.

For the exam, this topic recurs in the UPSC GS Paper III science-and-technology segment and in current-affairs sections of CSS, BCS, and FSOT. Prelims questions test factual recall—which body regulates GMOs (GEAC), which Act covers it, the year of Bt cotton approval, the BioE3 policy. Mains and interview questions probe the GM-crops debate (biosafety versus food security), ethics of gene editing and CRISPR, biopiracy under the Biological Diversity Act 2002, and India's vaccine diplomacy. Candidates should pair each technology with its specific regulator, statute, and dated instance.