Biopharma SHAKTI Scheme: India’s Push to Become Global Biopharma Hub

In the Union Budget 2026, the Union Minister for Finance announced the Biopharma SHAKTI scheme to position India as a global manufacturing hub for biopharmaceuticals.

About Biopharma SHAKTI

• Full Form: Biopharma SHAKTI stands for Strategy for Healthcare Advancement through Knowledge, Technology and Innovation.
• Financial Outlay: The scheme has an outlay of ₹10,000 crore over five years.
• Core Objective: The scheme aims to build a comprehensive ecosystem for domestic production of advanced biopharmaceutical products, enhancing healthcare security and industrial competitiveness.
• Nodal Ministry: Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers
• Disease Focus: The programme prioritises non-communicable diseases (NCDs) such as cancer, diabetes, and autoimmune disorders by encouraging domestic production of biologics and biosimilars.
• Medicines Covered:
  • Biologics: The scheme focuses on domestic manufacturing of biological medicines, which are complex drugs derived from living organisms or their components such as proteins and genes.
  • Biosimilars: The scheme also aims to scale up the production of biosimilars, which are highly similar versions of approved biological medicines and offer cost-effective treatment options
• Manufacturing Complexity: These medicines involve sophisticated processes related to purification, processing, and quality control, making them strategically significant.

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Infrastructure and Institutional Support

• Pharmaceutical Education and Research: The scheme proposes the establishment of three new National Institutes of Pharmaceutical Education and Research (NIPERs).
• Upgradation of Existing Institutions: Seven existing NIPERs will be upgraded as part of a biopharma-focused institutional network.
• Clinical Ecosystem: A national network of over 1,000 accredited clinical trial sites will be developed to support research, testing and regulatory approvals.
• Regulatory Strengthening: The Central Drugs Standard Control Organisation (CDSCO) will be strengthened through the creation of a dedicated scientific review cadre and specialist workforce to meet global regulatory standards and approval timelines.

Rationale Behind the Scheme

• Epidemiological Transition: India’s disease burden is increasingly dominated by non-communicable diseases such as diabetes, cancer, cardiovascular diseases and autoimmune disorders.
• Mortality Profile: Non-communicable diseases account for 63% of total deaths in India, with cardiovascular diseases being the leading cause.
• Global Trade Uncertainty: The scheme gains significance in light of proposed high tariffs on branded pharmaceutical imports by the United States, creating vulnerabilities for export-oriented pharma markets.
• Strategic Diversification: Moving into biologics and biosimilars reduces reliance on generics alone and protects India from drug-specific trade barriers.

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Strategic Significance of Biopharma SHAKTI

• Healthcare Security: The scheme strengthens India’s capacity to produce advanced medicines for chronic and life-threatening diseases.
• Industrial Upgradation: It facilitates India’s transition from a generic drug supplier to a producer of complex, high-value biopharmaceuticals.
• Export Resilience: Diversification into biologics and biosimilars helps cushion India’s pharma sector against evolving global trade restrictions.
• Innovation Ecosystem: Investment in research, clinical trials and regulatory capacity enhances long-term pharmaceutical innovation.
• Affordable Healthcare: Domestic biosimilar production improves access to high-cost therapies at affordable prices.

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