UPSC Prelims Practice Questions — Implementation of Biopharma SHAKTI

Q1. With reference to the Biopharma SHAKTI scheme, consider the following statements: Which of the statements given above is/are correct?

1. It is a Central Sector Scheme implemented by the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers.
2. Unlike the National Biopharma Mission, which is anchored in the Department of Biotechnology, Biopharma SHAKTI is anchored in the Department of Pharmaceuticals.
3. In its name, 'SHAKTI' expands to 'Scheme for Health, Affordable Knowledge, Technology and Innovation'.

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

Q2. In 'Biopharma SHAKTI', the acronym SHAKTI stands for which one of the following?

• A. Strategy for Healthcare Advancement through Knowledge, Technology and Innovation
• B. Scheme for Holistic Advancement of Knowledge in Therapeutics and Immunology
• C. Strategic Healthcare Action for Knowledge Transfer and Industrialisation
• D. System for Health Access, Knowledge, Technology and Innovation

Q3. With reference to the objectives and design of Biopharma SHAKTI, consider the following statements: Which of the statements given above is/are correct?

1. It seeks to move India from a generics-dominated industry towards a hub for high-value biologics and biosimilars.
2. It targets capturing about 5% of the global biopharmaceutical market.
3. Its proposed network of 1,000 accredited clinical trial sites is to be created under the Department of Biotechnology.

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

Q4. In the context of Biopharma SHAKTI, the term 'Non-Animal Methodologies (NAMs)' refers to which one of the following?

• A. Advanced techniques such as organoids and organ-on-a-chip used to assess drug safety and efficacy without relying on animal testing
• B. Manufacturing processes that exclude animal-derived raw materials in vaccine production
• C. Fermentation-based methods that substitute microbial cultures for animal-sourced APIs
• D. Standardised veterinary drug-testing protocols mandated before human biologics trials

Q5. Biopharma SHAKTI was announced as a new initiative in which one of the following?

• A. Union Budget 2026-27
• B. Union Budget 2025-26
• C. Interim Union Budget 2024-25
• D. Economic Survey 2025-26

Q6. Of the combined Rs 13,000 crore provision announced for Biopharma SHAKTI together with dedicated chemical parks, the Biopharma SHAKTI scheme alone accounts for how much?

• A. Rs 10,000 crore
• B. Rs 3,300 crore
• C. Rs 13,000 crore
• D. Rs 6,500 crore

Q7. Among the following pharmaceutical and biotechnology schemes of the Government of India, which one has the largest financial outlay?

• A. Production Linked Incentive (PLI) Scheme for Pharmaceuticals — Rs 15,000 crore
• B. Biopharma SHAKTI — Rs 10,000 crore
• C. Bulk Drug Parks Scheme — Rs 3,000 crore
• D. National Biopharma Mission (Innovate in India)

Q8. Consider the following statements comparing Biopharma SHAKTI with earlier pharmaceutical and biotech initiatives: Which of the statements given above is/are correct?

1. The Production Linked Incentive (PLI) Scheme for Pharmaceuticals was launched in 2020, before Biopharma SHAKTI.
2. The National Biopharma Mission is implemented by BIRAC under the Department of Biotechnology, whereas Biopharma SHAKTI is implemented by the Department of Pharmaceuticals.
3. Biopharma SHAKTI is the only Government scheme that supports bulk drug/API manufacturing in India.

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

Q9. Which one of the following best describes a 'biosimilar'?

• A. A biological product highly similar to an already approved reference biologic, with no clinically meaningful differences in safety, purity and potency
• B. An exact, chemically identical replica of a small-molecule generic drug
• C. A wholly novel biologic carrying an entirely new mechanism of action
• D. A medicine produced solely through chemical synthesis rather than living cells

Q10. To help India meet global approval timelines for biologics, Biopharma SHAKTI proposes to create a dedicated 'Scientific Review Cadre' within which one of the following regulatory bodies?

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

Q11. Under Biopharma SHAKTI, specialised biopharma human resources are to be expanded by establishing three new institutes and upgrading seven existing ones — these institutes are of which type?

• A. National Institutes of Pharmaceutical Education and Research (NIPERs)
• B. All India Institutes of Medical Sciences (AIIMS)
• C. Indian Institutes of Science Education and Research (IISERs)
• D. National Institutes of Biologicals (NIBs)

Q12. Consider the following statements about how Biopharma SHAKTI maps across policy dimensions: Which of the statements given above is/are correct?

1. Its push for domestic biologics and biosimilars manufacturing relates to the science & technology and economic dimensions.
2. Its focus on affordable treatment of non-communicable diseases such as cancer and diabetes relates to the health-policy dimension.
3. It is a Centrally Sponsored Scheme funded on a 60:40 Centre-State sharing basis.

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