Biopharma SHAKTI: Building India as a Global Biopharmaceutical Manufacturing Hub

Why in News ?

In the Union Budget 2026–27, the Union Minister for Finance announced the launch of the Biopharma SHAKTI initiative to strengthen India’s position in the global biopharmaceutical value chain and expand domestic capabilities in advanced therapies.

What is Biopharma SHAKTI ?

Biopharma SHAKTI stands for Strategy for Healthcare Advancement through Knowledge, Technology & Innovation.
It is a national initiative aimed at transforming India into a global hub for biopharmaceutical manufacturing, research, and innovation.

The programme focuses on building a robust ecosystem for the domestic production of biologics and biosimilars, reducing dependence on imports, and enhancing access to advanced therapies.

Key Components of the Initiative

1. Expansion of NIPER Network
   • Establishment of 3 new National Institutes of Pharmaceutical Education and Research (NIPERs).
   • Upgradation of 7 existing NIPERs with a biopharma focus.
   • These institutions will serve as centres of excellence for education, research, and skill development.
2. National Clinical Trials Network
   • Creation of a pan-India network of clinical trial sites.
   • Will strengthen India’s clinical research capacity and improve access to innovative therapies.
3. Advanced Biomanufacturing Infrastructure
   • Investment in state-of-the-art biomanufacturing facilities.
   • Support for scale-up, quality assurance, and regulatory compliance.
4. Innovation and Industry Linkages
   • Promotion of industry–academia collaboration.
   • Support for startups, technology transfer, and indigenous innovation.

Strategic Significance

Biopharma SHAKTI is designed to:

• Position India as a global manufacturing hub for biologics and biosimilars.
• Reduce import dependence and enhance pharmaceutical self-reliance.
• Support the treatment of non-communicable diseases (NCDs) such as cancer, diabetes, and autoimmune disorders.
• Catalyse investments in high-value, next-generation therapies, including monoclonal antibodies, vaccines, and gene-based treatments.
• Strengthen India’s role in global healthcare supply chains, particularly for affordable medicines.

Why Focus on Biologics and Biosimilars ?

Biologics

• These are complex medicines derived from living organisms.
• Used in treating chronic and life-threatening diseases such as cancer, autoimmune disorders, and rare diseases.
• Their complex manufacturing processes have traditionally limited access, especially in low- and middle-income countries.

Biosimilars

• These are highly similar versions of biologic medicines.
• Developed through rigorous analytical, preclinical, and clinical testing to ensure therapeutic equivalence.
• Offer safe and effective alternatives at lower costs, increasing competition and expanding patient access.

Way Forward

To ensure the success of Biopharma SHAKTI, India must:

• Ensure regulatory harmonisation with global standards.
• Strengthen intellectual property frameworks to encourage innovation.
• Build a skilled workforce through specialised training programmes.
• Promote public–private partnerships in R&D and manufacturing.
• Integrate the initiative with national health programmes to ensure affordable access to advanced therapies.