Transforming the “Pharmacy of the World” into a high-value biological powerhouse.
The global pharmaceutical landscape is shifting towards biopharmaceuticals. India has launched “Biopharma SHAKTI” (Strategy for Healthcare Advancement through Knowledge, Technology and Innovation), a national initiative to transform its role in the global bioeconomy.
Announced in the Union Budget 2026 with a ₹10,000 crore outlay over five years, it aims to elevate India from a generic drug manufacturing leader to a Biopharma manufacturing hub for high-value biologics and biosimilars. India, known as the “pharmacy of the world” for generics, faces the challenge and opportunity presented by complex biological drugs crucial for treating non-communicable diseases (NCDs).
“Biopharma SHAKTI seeks to build an end-to-end ecosystem for domestic production, enhancing healthcare accessibility, reducing import reliance, and establishing India as a self-reliant and innovative player.”
Strategic Imperative Behind Biopharma SHAKTI
The initiative is driven by several critical factors that define India’s future healthcare trajectory:
- Shifting Disease Burden: Increasing prevalence of NCDs requires affordable biologic medicines produced domestically.
- Reducing Import Dependence: Cultivating indigenous manufacturing to reduce supply chain vulnerabilities and costs.
- Global Bioeconomy Position: Moving beyond generics to innovate in the high-end biological sector.
Pillars of Progress
I. Nurturing Innovation: Expanding the NIPER Network
Investment in human capital is at the heart of SHAKTI. The government is establishing three new National Institutes of Pharmaceutical Education and Research (NIPERs) and upgrading seven existing ones. These institutions serve as hubs for innovation, cutting-edge research, and specialized talent pools.
Specializations range from medical device manufacturing and bulk drug R&D to phytopharmaceuticals and biological therapeutics. NIPER Ahmedabad and Guwahati are already leading in biotechnology and medicinal chemistry, fostering collaborations between industry and startups.
II. Global-Standard Clinical Trials
With a network of over 1,000 accredited clinical trial sites, India is accelerating drug development while ensuring strict regulatory compliance. This network facilitates everything from early-phase to large-scale pivotal trials.
Key Regulatory Compliance:
- CDSCO & DCGI Approval
- Institutional Ethics Committee
- CTRI Registration
- NDCTR 2019 Adherence
III. Agile Regulation
Strengthening the CDSCO has been a priority, with the establishment of a dedicated scientific review cadre. Recent reforms have slashed approval times for certain categories from 90 to 45 days through the Early Notice System.
IV. Developing Human Capital
Ensuring a skilled workforce is vital. Organizations like the Life Sciences Sector Skill Development Council (LSSSDC) and the National Biopharma Mission (NBM) are bridging the gap between academia and industry requirements through specialized training and grant funding.
Beyond Borders: Global Impact
Economic Benefits
Significant foreign exchange savings and numerous job opportunities across the value chain, stimulating growth in related industries and contributing to India’s GDP.
Global Positioning
Establishment as a supplier of affordable biosimilars to the world, particularly addressing the demand in developing countries with cost-effective solutions.
Conclusion
The “Biopharma SHAKTI” initiative is a significant step for India towards global leadership in biopharmaceutical manufacturing. With substantial financial commitment and infrastructure growth, India is poised for transformation. This strategic shift will enhance national health security, make advanced medicines more affordable, and solidify India’s role as a key player in global healthcare.
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