India’s ₹10,000 Crore Biopharma SHAKTI Initiative Unveiled
In a significant move to bolster India’s biopharmaceutical sector, Finance Minister Nirmala Sitharaman announced the launch of the Biopharma SHAKTI initiative during the Union Budget 2026. The ₹10,000 crore program, spread over five years, aims to transform India into a global hub for biologics and biosimilars manufacturing.
Strategic Goals and Institutional Expansion
The Biopharma SHAKTI initiative, which stands for Strategy for Healthcare Advancement through Knowledge, Technology, and Innovation, seeks to establish a comprehensive ecosystem for biopharmaceutical manufacturing. A major component of this strategy is the establishment of three new National Institutes of Pharmaceutical Education and Research (NIPERs) and the upgrading of seven existing ones. These institutions will play a crucial role in fostering research, developing talent, and facilitating industry collaboration.
Enhancing Clinical Trials and Regulatory Framework
To support research and innovation in complex therapies, the initiative will establish a nationwide network of over 1,000 accredited clinical trial sites. This infrastructure is expected to streamline the development of new therapies and bring them to market more efficiently.
Additionally, the Central Drugs Standard Control Organisation (CDSCO) will be strengthened with a dedicated scientific review cadre and expert panels. These enhancements aim to ensure faster and globally aligned drug approvals, thereby reducing the time to market for new biopharmaceutical products.
Industry and Expert Reactions
Industry leaders have welcomed the initiative, seeing it as a major boost to India’s ambitions in biosimilars. Shreehas Tambe of Biocon Biologics remarked that the initiative would enhance domestic manufacturing and innovation capabilities. The focus on innovation and infrastructure creation has been praised by various stakeholders in the pharmaceutical sector.
Dr. Mayuri Yeole, a clinical geneticist, highlighted the shift towards genomic self-reliance, noting the initiative’s potential to transform India’s pharmaceutical landscape. However, she cautioned that long-term access to therapies, especially for rare diseases, remains a concern.
Market Implications and Future Outlook
India’s pharmaceutical exports reached US$30.47 billion in 2024-25, reflecting a growth of 9.4% over the previous year. This growth underscores the sector’s global outreach and establishes a strong foundation for the Biopharma SHAKTI initiative. The domestic market, currently valued at around US$60 billion, is projected to double to US$130 billion by 2030, highlighting the long-term potential of targeted investments like Biopharma SHAKTI.
While the industry is optimistic, some analysts, including those from the Financial Times, have described the budget as lacking transformational depth despite its sectoral highlights. The real impact of the initiative will depend on effective execution, particularly in areas such as affordability and access to treatments.
Conclusion
The Biopharma SHAKTI initiative represents a strategic shift for India, positioning it as a global leader in biopharmaceutical manufacturing and innovation. By focusing on education, research, regulatory frameworks, and export scaling, the initiative aims to create a holistic ecosystem for the sector. As the program unfolds, its success will hinge on addressing execution challenges and ensuring broad access to its benefits.
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