Union Budget 2026: Biopharma SHAKTI Scheme Targets Global Biopharma Leadership Amid US Tariff Pressures
Contents4
Indian Express - Explained · 15 Feb 2026 · 2 min read
Prelims · Government schemes Mains · GS3 Economy High relevance
The Union Budget 2026 introduced the Biopharma SHAKTI scheme with ₹10,000 crore allocation to position India as a global biopharma hub, strategically responding to shifting disease burdens and US tariff threats on pharmaceutical imports.
Key points
Biopharma SHAKTI is a ₹10,000 crore scheme over 5 years to develop India's biopharmaceutical ecosystem, focusing on biologics and biosimilars production to address non-communicable diseases (NCDs) like cancer and diabetes.
Biological medicines derived from living organisms will receive priority, given their complexity and India's current import dependence, despite being crucial for treating NCDs causing 63% of deaths nationally.
[GS3-Economy] The scheme responds to US tariff threats (up to 250% on patented drugs) by diversifying exports beyond generics, leveraging India's existing position as supplier of 20% global generic demand.
Infrastructure push includes 3 new NIPERs, 7 upgraded institutes, and 1,000 clinical trial sites to strengthen domestic R&D capacity in biopharmaceuticals.
CDSCO reforms will enhance regulatory standards through specialized scientific review cadres, aligning with global approval timelines for biologics.
[GS2-Governance] The scheme integrates with National Skills Qualification Framework to train 1.5 lakh geriatric caregivers, addressing healthcare workforce gaps for aging populations.
Medical tourism hubs will combine AYUSH and modern medicine facilities, targeting integrated healthcare complexes to boost health sector employment.
Way Forward: India should establish a Biopharma Mission under DBT to coordinate public-private R&D, create patent pools for biosimilars, and negotiate mutual recognition agreements for drug approvals with key markets like EU and Japan.
Key terms
- Biologics
- Complex medicines derived from living organisms (proteins, genes) used to treat cancers, autoimmune diseases. Unlike chemical drugs, they require advanced manufacturing infrastructure. UPSC relevance: Critical for India's pharmaceutical sector upgrade under Make in India 2.0 and healthcare self-reliance.
- Biosimilars
- Highly similar but not identical versions of original biologic drugs, offering cost-effective alternatives. UPSC relevance: Key to affordable healthcare under Ayushman Bharat and India's potential $100 billion bioeconomy target by 2030.
- CDSCO
- Central Drugs Standard Control Organization, India's national regulatory body for pharmaceuticals. UPSC relevance: Its strengthening under Biopharma SHAKTI aligns with WHO's Global Benchmarking Tool standards for vaccine and drug regulation.
- NIPER
- National Institutes of Pharmaceutical Education and Research, autonomous institutes under DPIIT focusing on pharma education and research. UPSC relevance: Expansion under this scheme addresses skill gaps in specialized drug manufacturing sectors.
Practice question
Discuss the strategic objectives and potential challenges of the Biopharma SHAKTI scheme in positioning India as a global biopharmaceutical hub. (250 words, 15 marks)
GS3 15 marks 250 words Mains
Key terms to include: Biologics Biosimilars CDSCO NIPERs NSQF Make in India 2.0 Ayushman Bharat Bioeconomy
Answer framework
Introduction
Briefly introduce the Biopharma SHAKTI scheme, its allocation, and its aim to make India a global biopharmaceutical leader.
Strategic Objectives
Diversify pharmaceutical exports beyond generics to biologics and biosimilars to counter US tariff threats.
Address the growing burden of non-communicable diseases (NCDs) like cancer and diabetes through domestic production of biologics.
Strengthen R&D infrastructure with new NIPERs, upgraded institutes, and clinical trial sites.
Enhance regulatory standards via CDSCO reforms to align with global approval timelines.
Potential Challenges
High complexity and cost of biologics production compared to traditional generics.
Dependence on imports for biologics despite domestic production push.
Need for skilled workforce in biopharmaceuticals, addressed through NSQF integration.
Regulatory hurdles in achieving global recognition for biosimilars.
Economic and Healthcare Impact
Boost to Make in India 2.0 and healthcare self-reliance.
Potential to tap into the $100 billion bioeconomy target by 2030.
Affordable healthcare through biosimilars under Ayushman Bharat.
Conclusion
Suggest a way forward, such as establishing a Biopharma Mission under DBT, creating patent pools, and negotiating mutual recognition agreements with key markets.
Fact check
All facts verified