- Why in news
- A PIB Budget 2026-27 explainer on 2 February 2026 outlined Biopharma SHAKTI, a Rs 10,000 crore, five-year push for biologics and biosimilars, and the schemes around it.
- What it is
- Biopharma SHAKTI stands for Strategy For Healthcare Advancement Through Knowledge, Technology And Innovation. It aims to build an ecosystem for making biologics and biosimilars in India. Biologics are medicines made from living cells, and biosimilars are near-copies of approved biologics.
- Outlay and period
- Biopharma SHAKTI has an outlay of Rs 10,000 crore over five years, announced in Union Budget 2026-27.
- NIPERs
- Three new NIPERs are to be set up and seven existing NIPERs upgraded to supply specialised biopharma manpower.
- Clinical trial sites
- The plan is to develop over 1,000 accredited clinical trial sites across the country.
- Regulator capacity
- CDSCO is to be strengthened by inducting specialised scientific and technical staff, for faster approvals of complex products.
- PRIP
- PRIP was launched in 2023 by the Department of Pharmaceuticals with Rs 5,000 crore outlay.
- Aim
- It builds the ecosystem for domestic production of biologics and biosimilars.
- Regional Medical Hubs
- A scheme will support States in setting up five Regional Medical Hubs with the private sector, to promote medical tourism.
- Allied health professionals
- Existing AHP institutions will be upgraded and 100,000 AHPs added over 5 years, covering 10 disciplines.
- Caregivers
- NSQF-aligned programmes will train multi-skilled caregivers; 1.5 lakh are to be trained in the coming year.
- Mental health
- A NIMHANS-2 will be set up and the National Mental Health Institutes in Ranchi and Tezpur upgraded as Regional Apex Institutions.
Don’t confuse with Biologics vs biosimilars: Biologics are medicines made from living cells; biosimilars are near-copies of an already approved biologic.
Don’t confuse with NBM vs BioE3 vs Bio-RIDE: NBM (2017) funds biopharma product development via BIRAC; BioE3 is a 2024 policy for biomanufacturing; Bio-RIDE is a 2024 DBT umbrella scheme.
Schemes: 52 Prelims questions since 2013, 10 in Prelims 2026 alone. They test features, the period and who funds it. In Mains, 33 news-triggered questions, mostly GS3.
Why it matters
- Moves India from low-cost generics to high-value biologics, reducing import dependence.
- Meets rising demand for biologic therapies as non-communicable diseases grow.
- Domestic biologics capacity can cut import dependence and lower the cost of costly medicines.
- Skilled health workers and medical hubs can create jobs and boost medical value tourism.
Problems
- Biologics are complex and costly to make, needing skilled staff and strict quality control.
- Slow approvals and thin clinical trial capacity can delay products.
- Biologics need high capital, advanced R&D and strict regulatory approval, and India has gaps in all three.
Way forward
- Build trained manpower and regulatory capacity together with manufacturing.
- Align approval timelines with global standards and expand accredited trial sites.
- Pair the outlay with a clear regulatory pathway for biosimilars and with industry-academia research links.
Put in your answer
PRIP scheme: Rs 5,000 crore scheme (2023) supporting R&D in new drugs, biosimilars and medical devices.
India's pharma ranking: India ranks 3rd in pharmaceutical production by volume and 11th by value.
Biopharma SHAKTI outlay: ₹10,000 crore over 5 years to build domestic biologics and biosimilars capacity.
Skilling target: 100,000 new allied health professionals over 5 years across 10 disciplines.
- 2018Mains GS3 · Q15Why is biotechnology activity high in India, and how has it benefited biopharma?
- 2022Mains GS3 · Q16Basic vaccine development principle, how vaccines work, and Indian COVID-19 vaccine approaches.
- 2021Mains GS3 · Q15Applied biotechnology achievements and how they uplift poorer sections of society.
- 2017Mains GS3 · Q6Describe stem cell therapy and its advantages over other treatments.
UPSC’s own questions that come close to this issue, from our Prelims and Mains banks.
Prelims practice · Statements
Ours, not from a UPSC paper
Consider the following statements:
- 1.Biopharma SHAKTI, announced in Union Budget 2026-27, has an outlay of Rs 10,000 crore over five years.
- 2.Under Biopharma SHAKTI, three new NIPERs are to be set up and seven existing NIPERs are to be upgraded.
- 3.The National Biopharma Mission is implemented by the Indian Council of Medical Research.
Which of the statements given above is/are correct?
True or false?
1 of 13
Statements the way Prelims prints them. Say first, then see the fact.
1.Biopharma SHAKTI has an outlay of Rs 10,000 crore over five years.
True. Rs 10,000 crore over five years.
2.Under the initiative, three new NIPERs are to be established and seven existing ones upgraded.
True. Three new NIPERs and upgrade of seven.
3.It includes strengthening CDSCO, the drug regulator, by inducting specialised scientific and technical personnel.
True. CDSCO capacity is to be enhanced.
4.The National Biopharma Mission is implemented by the Indian Council of Medical Research.
False. It is implemented by BIRAC under the Department of Biotechnology.
5.The National Biopharma Mission is co-funded by the World Bank.
True. NBM is co-funded by the World Bank.
6.The PRIP scheme is run by the Department of Biotechnology.
False. PRIP was launched by the Department of Pharmaceuticals.
7.Biopharma SHAKTI has an outlay of ₹10,000 crore over the next 5 years.
True. The outlay is ₹10,000 crore over 5 years.
8.Biopharma SHAKTI is meant to build an ecosystem for domestic production of biologics and biosimilars.
True. Its focus is domestic production of biologics and biosimilars.
9.The Budget proposes a scheme to support States in setting up ten Regional Medical Hubs in partnership with the private sector.
False. The number of Regional Medical Hubs is five.
10.The proposed Regional Medical Hubs are to include AYUSH Centres and Medical Value Tourism Facilitation Centres.
True. The hubs will have AYUSH Centres and Medical Value Tourism Facilitation Centres.
11.The Budget proposes to add 1,00,000 allied health professionals over the next 10 years.
False. The addition is over the next 5 years.
12.The WHO Global Traditional Medicine Centre to be upgraded under the Budget proposals is located at Jamnagar.
True. The centre is at Jamnagar, Gujarat.
13.The Budget proposes to upgrade the National Mental Health Institutes at Ranchi and Tezpur as Regional Apex Institutions.
True. Ranchi and Tezpur institutes become Regional Apex Institutions.
Written by us from the release, not by UPSC; checked by a second model.
Worth revising until Prelims 2027: most news questions come within two years of the event.