UPSC Prelims Practice Questions — Biopharma SHAKTI Scheme

Q1. The ₹10,000 crore outlay announced for the Biopharma SHAKTI scheme in the Union Budget 2026-27 is spread over how many years?

• A. Three years
• B. Four years
• C. Five years
• D. Seven years

Q2. Biopharma SHAKTI — Strategy for Healthcare Advancement through Knowledge, Technology and Innovation — was proposed in which of the following Union Budgets?

• A. Union Budget 2023-24
• B. Union Budget 2024-25
• C. Union Budget 2025-26
• D. Union Budget 2026-27

Q3. With reference to the institutional lineage that Biopharma SHAKTI builds upon, consider the following pairings of scheme/policy with its administering body: 1. National Biopharma Mission — Biotechnology Industry Research Assistance Council (BIRAC) 2. PLI Scheme for Pharmaceuticals — Department of Pharmaceuticals 3. BioE3 Policy — Department of Biotechnology 4. Bio-RIDE Scheme — Department of Pharmaceuticals Which of the above are correctly identified?

1. National Biopharma Mission — Biotechnology Industry Research Assistance Council (BIRAC)
2. PLI Scheme for Pharmaceuticals — Department of Pharmaceuticals
3. BioE3 Policy — Department of Biotechnology
4. Bio-RIDE Scheme — Department of Pharmaceuticals

• A. 1, 2 and 3
• B. 1 and 4
• C. 2, 3 and 4
• D. 1, 2, 3 and 4

Q4. The National Biopharma Mission (2017), a precursor to today's biopharma push, was 50% co-funded by which of the following institutions?

• A. World Bank
• B. Asian Development Bank
• C. International Monetary Fund
• D. Asian Infrastructure Investment Bank

Q5. The BioE3 Policy, with which Biopharma SHAKTI is aligned, sets as its headline target the building of an Indian bioeconomy of what size by 2030?

• A. US$150 billion
• B. US$300 billion
• C. US$500 billion
• D. US$1 trillion

Q6. The BioE3 (Biotechnology for Economy, Environment and Employment) Policy was approved by the Union Cabinet in which year?

• A. 2022
• B. 2023
• C. 2024
• D. 2025

Q7. With reference to the distinction between biologics, biosimilars and conventional generics relevant to the scope of Biopharma SHAKTI, consider the following statements: 1. A biosimilar is a biological product that is highly similar to an already-licensed reference biologic. 2. Unlike conventional chemically-synthesised generics, biologics are produced using living systems such as engineered cells. 3. A biosimilar must be an exact, identical copy of its reference biologic with no permissible differences whatsoever. Which of the statements given above is/are correct?

1. A biosimilar is a biological product that is highly similar to an already-licensed reference biologic.
2. Unlike conventional chemically-synthesised generics, biologics are produced using living systems such as engineered cells.
3. A biosimilar must be an exact, identical copy of its reference biologic with no permissible differences whatsoever.

• A. 1 only
• B. 1 and 2 only
• C. 2 and 3 only
• D. 1, 2 and 3

Q8. At the global level, the framework guidelines for evaluating the quality, safety and efficacy of biosimilars (similar biotherapeutic products) are provided by which of the following organisations?

• A. World Trade Organization
• B. World Health Organization
• C. World Intellectual Property Organization
• D. Food and Agriculture Organization

Q9. With reference to the administrative jurisdiction of Biopharma SHAKTI, consider the following statements: 1. The scheme is administered by the Department of Pharmaceuticals. 2. The Department of Pharmaceuticals functions under the Ministry of Chemicals and Fertilizers. 3. The BioE3 Policy is administered by the same department that administers Biopharma SHAKTI. 4. The body to be strengthened with a dedicated Scientific Review Cadre under the scheme is the CDSCO. Which of the statements given above are correct?

1. The scheme is administered by the Department of Pharmaceuticals.
2. The Department of Pharmaceuticals functions under the Ministry of Chemicals and Fertilizers.
3. The BioE3 Policy is administered by the same department that administers Biopharma SHAKTI.
4. The body to be strengthened with a dedicated Scientific Review Cadre under the scheme is the CDSCO.

• A. 1 and 3
• B. 1, 2 and 4
• C. 2 and 4
• D. 1, 2, 3 and 4

Q10. Biopharma SHAKTI, announced as part of the manufacturing push across seven strategic and frontier sectors in the Union Budget 2026-27, is to be operationalised by which of the following?

• A. Department of Biotechnology
• B. Department of Pharmaceuticals
• C. Indian Council of Medical Research
• D. Ministry of Health and Family Welfare

Q11. Under Biopharma SHAKTI, which is the lead regulatory body to be strengthened with a dedicated Scientific Review Cadre, including specialists for fields such as gene therapy?

• A. Central Drugs Standard Control Organisation (CDSCO)
• B. National Pharmaceutical Pricing Authority (NPPA)
• C. Indian Council of Medical Research (ICMR)
• D. Central Drugs Laboratory (CDL)

Q12. The Production Linked Incentive (PLI) Scheme for Pharmaceuticals (2021), a predecessor to Biopharma SHAKTI, provides incentives for identified products grouped under how many product categories?

• A. Two
• B. Three
• C. Four
• D. Five