Biopharma SHAKTI: India's plan for biologics and clinical trial sites
Why in news: On 14 October 2026, NIPER Raebareli and AstraZeneca India signed an MoU to build trained staff and inspection-ready clinical trial sites in 25 locations.
Biopharma SHAKTI is a ₹10,000-crore, five-year strategy announced in the Union Budget 2026-27 to make India a manufacturing hub for biologics and biosimilars. The Department of Pharmaceuticals is its nodal department, and it plans over 1,000 accredited clinical trial sites. On 14 October 2026, NIPER Raebareli signed an MoU to ready 25 such sites.
Syllabus: GS3 · Liberalisation & Industry; GS2 · Government Policies; GS2 · Health, Education & Human Resources
Why this matters for UPSC
GS III, industrial policy and biotechnology, and GS II, health: Prelims can ask Biopharma SHAKTI's ministry, outlay and components, NIPERs and CDSCO; Mains, whether India can move from generics to biologics.
In short
Biopharma SHAKTI is a ₹10,000-crore, five-year strategy proposed in the Union Budget 2026-27 to build domestic production of biologics and biosimilars, with the Department of Pharmaceuticals as nodal department.
Biopharma SHAKTI will be judged by a notified design, accredited trial sites and faster CDSCO reviews that keep safety intact, not by its outlay alone.
Why it matters
A patient with cancer, diabetes or an autoimmune disease often needs a biologic medicine, and many such medicines are expensive and still imported. If Indian firms can make biosimilars at home and test them in Indian hospitals, the same treatment can become cheaper and easier to find. Trial sites in smaller cities also bring new therapies closer to patients there and create work for trained nurses, pharmacists and study coordinators. The larger question is whether a drug industry built on low-cost generics can climb to complex, high-value medicines while its regulator stays strict enough to keep every trial safe and ethical.
Prelims pointers
- NIPER Act, 1998: gave statutory recognition to the first NIPER, at Mohali (Punjab), set up earlier as a society under the Societies Registration Act, 1860.
- After the 2007 amendment, NIPERs came up at Ahmedabad, Guwahati, Hajipur, Hyderabad, Kolkata and Raebareli; all seven are Institutions of National Importance.
- CDSCO: part of the Directorate General of Health Services, Ministry of Health and Family Welfare; it acts for the Centre under the Drugs and Cosmetics Act, 1940.
- New Drugs and Clinical Trials Rules, 2019: ethics committees overseeing trials must be registered with the Central Licensing Authority.
- PLI Scheme for Pharmaceuticals: Cabinet approval in February 2021, FY2020-21 to 2028-29, incentives of about ₹15,000 crore.
- PRIP scheme: ₹5,000 crore, notified on 17 August 2023 by the Department of Pharmaceuticals; Component A funds centres of excellence at NIPERs.
Practise a UPSC-style question
With reference to Biopharma SHAKTI, consider the following statements:
1. It was announced in the Union Budget 2026-27 with an outlay of ₹10,000 crore over five years.
2. Its nodal department is the Department of Biotechnology under the Ministry of Science and Technology.
3. It envisages a nationally accredited network of 1,000 clinical trial sites under the Indian Council of Medical Research.
Which of the statements given above is/are correct?
- (a) 1 and 2 only
- (b) 2 and 3 only
- (c) 1 and 3 only
- (d) 1, 2 and 3
Show the answer
Answer: (c) 1 and 3 only
Answer: (c) 1 and 3 only. The scheme sits with the Department of Pharmaceuticals, not the Department of Biotechnology.
Statement 1: correct. The Budget Speech of 1 February 2026 proposed Biopharma SHAKTI with ₹10,000 crore over the next five years.
Statement 2: incorrect. The Department of Pharmaceuticals, in the Ministry of Chemicals and Fertilizers, is the nodal department for the scheme.
Statement 3: correct. The government's March 2026 reply lists a nationally accredited network of 1,000 clinical trial sites under ICMR.
Eliminate: Statement 2 is wrong because the Department of Pharmaceuticals is the nodal department. Out: (a), (b), (d).
Trap: Swapped attribution. A biotech-sounding scheme is pinned on the Department of Biotechnology instead of the Department of Pharmaceuticals.
Remember: Biopharma SHAKTI = Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers; ₹10,000 crore, five years.
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