Biotechnology, Health Technology and Bioethics

What biotechnology is

Biotechnology uses living organisms, cells or their components to make products or solve problems.

Traditional biotech: fermentation (curd, bread, alcohol) and selective breeding.

Modern biotech: recombinant DNA technology (1970s), which cuts and joins DNA from different organisms using restriction enzymes and ligases, then inserts it into a host through vectors such as plasmids.

Colours of biotech:

• red: medical;
• green: agricultural;
• white: industrial;
• blue: marine;
• grey: environmental.

Key technologies

Genetic engineering and GM organisms: genes are transferred across species. Examples:

• Bt cotton: carries a gene from the soil bacterium *Bacillus thuringiensis* that produces an insecticidal protein against bollworms;
• insulin made by GM bacteria.

Genome editing (CRISPR-Cas9): precise cutting and editing of DNA, discovered by Jennifer Doudna and Emmanuelle Charpentier (Nobel Prize in Chemistry, 2020). It is used in:

• crops (India's genome-edited rice, 2025);
• gene therapy: the world's first approved CRISPR therapy, Casgevy, for sickle cell disease (2023 approvals).
• Indian institutes are developing low-cost CRISPR-based treatments for sickle cell disease.

India's sickle cell mission: the National Sickle Cell Anaemia Elimination Mission (2023) aims to eliminate the disease as a public health problem by 2047. It screens 7 crore people in tribal areas.

Stem cells: cells that can self-renew and differentiate.

• Embryonic stem cells are pluripotent.
• Adult stem cells are multipotent.
• Induced pluripotent stem cells (iPSCs) are reprogrammed adult cells (Yamanaka, Nobel 2012).

They are used in regenerative medicine. Stem cell therapies need ICMR guidelines, which ban unproven commercial therapies except approved ones such as bone marrow transplants.

Gene therapy: India's first indigenous CAR-T cell therapy, NexCAR19 (IIT Bombay and Immunoact), was approved in 2023 for blood cancers, at a fraction of the global cost. A gene therapy trial for haemophilia at CMC Vellore was reported in 2024–25.

Genomics:

• the Genome India Project, which sequenced about 10,000 genomes from 99 communities, with the data released in January 2025;
• the Human Genome Project (2003) and the complete telomere-to-telomere human genome (2022).

Uses: personalised medicine, disease prediction, and pharmacogenomics (how genes affect drug response).

Synthetic biology, mRNA and others:

• mRNA vaccines (Pfizer and Moderna for COVID; the Nobel in Medicine 2023 went to Karikó and Weissman). India developed Gemcovac, an mRNA COVID vaccine (Gennova, 2022).
• DNA vaccines: ZyCoV-D (2021) was the world's first DNA vaccine for humans.
• Monoclonal antibodies, biosimilars and 3D bioprinting.

India's biotech and health technology sector

Size: India's bioeconomy was valued at about $165 billion in 2024 (BIRAC report). The target is $300 billion by 2030.

Vaccines: India is a vaccine superpower, supplying about 60% of the world's vaccines by volume. The Serum Institute of India is the largest vaccine maker by doses.

COVID-19:

• Covaxin (Bharat Biotech with ICMR) was an inactivated vaccine;
• Covishield (Oxford–AstraZeneca, made by Serum);
• over 220 crore doses were administered through CoWIN;
• Vaccine Maitri sent doses to other countries.

Other vaccines:

• Rotavac (rotavirus, 2015);
• Cervavac, India's first indigenous HPV vaccine for cervical cancer (Serum, 2022).

Pharmaceuticals: India is the "pharmacy of the world". It is the largest supplier of generic drugs by volume (about 20% of global generic exports), supplying about 40% of US generic demand.

Weakness: dependence on China for active pharmaceutical ingredients (APIs), about 70%. PLI for bulk drugs (2020) and bulk drug parks respond to this.

Quality concerns: contaminated cough syrups linked to child deaths in The Gambia and Uzbekistan (2022) and in Madhya Pradesh (2025) led to tighter rules, such as the revised Schedule M (Good Manufacturing Practices).

Institutions and policies:

• the Department of Biotechnology (DBT, 1986);
• BIRAC (2012), which funds startups;
• the BioE3 Policy (Biotechnology for Economy, Environment and Employment, August 2024), which promotes bio-manufacturing hubs, bio-foundries and biotech for climate goals;
• Mission COVID Suraksha;
• the National Biopharma Mission (with the World Bank).

Digital health:

• the Ayushman Bharat Digital Mission (ABDM, 2021), with ABHA health IDs (over 70 crore created);
• eSanjeevani telemedicine;
• U-WIN for immunisation records;
• AI-based diagnostics, such as TB screening by chest X-ray.

Regulation of biotech

GM crops:

• the Genetic Engineering Appraisal Committee (GEAC) under the Environment Ministry approves the environmental release of GMOs, under the Environment (Protection) Act 1986, Rules 1989;
• GM food safety is FSSAI's remit.

Biological diversity: the Biological Diversity Act 2002 (amended in 2023) covers access and benefit sharing, through the National Biodiversity Authority in Chennai.

Drugs and clinical trials:

• the CDSCO (headed by the DCGI);
• the New Drugs and Clinical Trials Rules 2019;
• the Drugs and Cosmetics Act 1940, with a new Drugs, Medical Devices and Cosmetics Bill pending.

Assisted reproduction and surrogacy:

• the ART (Regulation) Act 2021;
• the Surrogacy (Regulation) Act 2021, which allows only altruistic surrogacy; an amendment in 2024 allowed donor gametes.

DNA profiling: the DNA Technology (Use and Application) Regulation Bill was withdrawn in 2023 over privacy concerns.

Bioethics

Issues:

• germline editing: the He Jiankui case (China, 2018) used CRISPR on embryos to create "designer babies", and was condemned worldwide;
• informed consent in trials;
• biopiracy: the turmeric and neem patents, which India successfully challenged, and basmati;
• genetic privacy and discrimination;
• equitable access to costly therapies;
• dual use (bioweapons): the Biological Weapons Convention (1972), to which India is a party.

Responses:

• the Traditional Knowledge Digital Library (TKDL, 2001), which prevents patents on traditional knowledge by giving patent offices access to prior art;
• ICMR's National Ethical Guidelines (2017).

Analysis

India's strengths are scale manufacturing, affordable innovation (CAR-T, vaccines) and a large genetic diversity for research.

Gaps:

• low R&D spending: India's gross expenditure on R&D is about 0.65% of GDP;
• regulatory delays;
• API dependence;
• quality lapses.

The goal: move from "pharmacy of the world" to "innovator of the world", with the Anusandhan National Research Foundation (ANRF Act 2023) and the ₹1 lakh crore RDI scheme (2025) funding private research.

Common prelims traps

• GEAC is under the Environment Ministry, not Agriculture or Health.
• ZyCoV-D was the first DNA vaccine; Gemcovac was India's mRNA vaccine.
• iPSCs are reprogrammed adult cells.
• CRISPR won the Chemistry Nobel; mRNA won the Medicine Nobel.

Practice: Mains question

*"Genome editing offers great promise but raises serious ethical questions." Discuss with reference to agriculture and human health in India. (250 words)*

Key terms

• Biosimilar: a biological drug highly similar to an approved original biological medicine.
• Monoclonal antibody: a laboratory-made antibody that targets a specific antigen.
• Biopiracy: commercial use of biological resources or traditional knowledge without permission or benefit sharing.
• Access and benefit sharing: a Nagoya Protocol principle that users of genetic resources share benefits with the communities that conserved them.
• Antimicrobial resistance: micro-organisms becoming resistant to drugs. India's Red Line campaign discourages antibiotics without prescription.

Quick self-test

1. *Why is germline editing more controversial than somatic gene therapy?* Changes to embryos or reproductive cells pass to future generations.
2. *Who approves clinical trials in India?* CDSCO, headed by the DCGI.
3. *What is the API problem?* Most raw ingredients for Indian generic drugs come from China.