UPSC Prelims Practice Questions — Transforming India into a Global Biopharma Hub
Q1. Biopharma SHAKTI, announced in the Union Budget 2026-27, is to be operationalised primarily under which one of the following?
- A. Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers
- B. Department of Biotechnology, Ministry of Science and Technology
- C. Central Drugs Standard Control Organisation, Ministry of Health and Family Welfare
- D. Indian Council of Medical Research, Ministry of Health and Family Welfare
Q2. Biopharma SHAKTI carries the largest single indicative outlay yet earmarked for India's biologics and biosimilars ecosystem in a Union Budget. This outlay is:
- A. ₹1,500 crore over five years
- B. ₹5,366 crore over five years
- C. ₹10,000 crore over five years
- D. ₹15,000 crore over five years
Q3. In the context of the National Biopharma Mission (2017), the programme 'Innovate in India (i3)' is best described as:
- A. An industry-academia collaborative programme to accelerate discovery research and early development of biopharmaceuticals
- B. A government scheme to procure and stockpile imported biologics for public hospitals
- C. A registry maintained by the ICMR for monitoring ongoing clinical trials in India
- D. A price-control mechanism for essential biosimilar medicines
Q4. With reference to the National Biopharma Mission – Innovate in India (i3), consider the following statements:
1. It was launched in 2017.
2. It is implemented by BIRAC under the Department of Biotechnology.
3. It is funded entirely through a World Bank loan.
4. It set the goal of building India into a USD 100 billion biotech industry by 2025.
Which of the statements given above are correctly identified?
- It was launched in 2017.
- It is implemented by BIRAC under the Department of Biotechnology.
- It is funded entirely through a World Bank loan.
- It set the goal of building India into a USD 100 billion biotech industry by 2025.
- A. 1, 2 and 3
- B. 1, 2 and 4
- C. 2, 3 and 4
- D. 1 and 4 only
Q5. With reference to the Biotechnology Industry Research Assistance Council (BIRAC), consider the following statements:
1. It provides access to risk capital through targeted funding to biotech enterprises.
2. It supports technology transfer and intellectual property management for biotech firms.
3. It is the implementing agency of the National Biopharma Mission.
4. It is the statutory authority that grants marketing approval for new drugs in India.
Which of the statements given above is/are NOT correct?
- It provides access to risk capital through targeted funding to biotech enterprises.
- It supports technology transfer and intellectual property management for biotech firms.
- It is the implementing agency of the National Biopharma Mission.
- It is the statutory authority that grants marketing approval for new drugs in India.
- A. 1 only
- B. 3 only
- C. 4 only
- D. 2 and 3
Q6. Which one of the following statements about the constitution of BIRAC is correct?
- A. It was set up in 2012 by the Department of Biotechnology as a Section 8 not-for-profit public sector enterprise.
- B. It was set up in 2007 by the Indian Council of Medical Research as a statutory body.
- C. It was set up in 2012 by the Department of Pharmaceuticals as a fully commercial public sector undertaking.
- D. It was set up in 2017 by the Department of Scientific and Industrial Research as a registered society.
Q7. With reference to the outcomes of the National Biopharma Mission, consider the following statements:
1. It supports 101 projects.
2. It has established 21 shared infrastructure facilities for research services and biomanufacturing.
3. It has supported the setting up of 16 clinical trial networks.
4. It has benefited more than 1,000 MSMEs.
Which of the statements given above are correctly identified?
- It supports 101 projects.
- It has established 21 shared infrastructure facilities for research services and biomanufacturing.
- It has supported the setting up of 16 clinical trial networks.
- It has benefited more than 1,000 MSMEs.
- A. 1 and 2 only
- B. 1, 2 and 3
- C. 2, 3 and 4
- D. 1, 3 and 4
Q8. With reference to the National Biopharma Mission, consider the following statements:
1. It supported ZyCoV-D, described as the world's first DNA-based COVID-19 vaccine.
2. It has introduced over 18 products to the market, including vaccines, biotherapeutics, devices and diagnostics.
3. It has generated over 1,000 jobs.
4. It was launched with a total outlay of ₹10,000 crore.
Which of the statements given above is/are NOT correct?
- It supported ZyCoV-D, described as the world's first DNA-based COVID-19 vaccine.
- It has introduced over 18 products to the market, including vaccines, biotherapeutics, devices and diagnostics.
- It has generated over 1,000 jobs.
- It was launched with a total outlay of ₹10,000 crore.
- A. 4 only
- B. 1 only
- C. 3 and 4
- D. 2 only
Q9. The Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical Key Starting Materials, Drug Intermediates and Active Pharmaceutical Ingredients is implemented by which one of the following?
- A. Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers
- B. Department for Promotion of Industry and Internal Trade, Ministry of Commerce and Industry
- C. Department of Biotechnology, Ministry of Science and Technology
- D. Central Drugs Standard Control Organisation, Ministry of Health and Family Welfare
Q10. Consider the following statements distinguishing categories of medicines:
1. A biosimilar is a biological product similar in quality, safety and efficacy to an already approved reference biologic.
2. Biologics are generally large, complex molecules derived from living organisms.
3. Small-molecule drugs are usually chemically synthesised and have relatively simple, well-defined structures.
4. In India, a biosimilar is approved through the same abbreviated route as a small-molecule generic, without any comparability exercise.
Which of the statements given above are correctly identified?
- A biosimilar is a biological product similar in quality, safety and efficacy to an already approved reference biologic.
- Biologics are generally large, complex molecules derived from living organisms.
- Small-molecule drugs are usually chemically synthesised and have relatively simple, well-defined structures.
- In India, a biosimilar is approved through the same abbreviated route as a small-molecule generic, without any comparability exercise.
- A. 1 and 2 only
- B. 2, 3 and 4
- C. 1, 2 and 3
- D. 1, 3 and 4
Q11. The Government of India's authorised agency for the promotion of pharmaceutical exports (Pharmexcil) functions under which one of the following?
- A. Ministry of Commerce and Industry
- B. Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers
- C. Ministry of Health and Family Welfare
- D. Department of Biotechnology, Ministry of Science and Technology
Q12. Which one of the following correctly describes the BioE3 Policy relevant to India's biomanufacturing push?
- A. The 'Biotechnology for Economy, Environment and Employment' Policy, approved by the Union Cabinet in 2024
- B. The 'Biotechnology for Economy, Environment and Employment' Policy, approved by the Union Cabinet in 2020
- C. The 'Bio-Energy and Environment Enhancement' Policy, approved by the Union Cabinet in 2024
- D. The 'Biotechnology for Exports and Employment' Policy, approved by the Union Cabinet in 2017