Biopharma SHAKTI Scheme: Strengthening India’s Biologics and Biosimilars Ecosystem

To bolster India’s domestic biopharmaceutical sector and elevate its global competitiveness in biologics and biosimilars, the Government has launched the Biopharma SHAKTI scheme, with an allocation of ₹10,000 crore over five years. The scheme’s overarching goal is to establish a world-class domestic ecosystem for biologics and biosimilars, promoting affordable healthcare for all and positioning India as a global hub for biopharmaceutical manufacturing and innovation.

Addressing India’s Shifting Disease Burden

India is witnessing a rising burden of non-communicable diseases such as diabetes, cancer, and autoimmune disorders. Biologic medicines play a pivotal role in improving longevity and quality of life at accessible costs. Recognising this, the Biopharma SHAKTI initiative is designed to propel India’s biopharmaceutical sector forward by supporting domestic innovation, manufacturing, and global competitiveness. 

Objectives of Biopharma SHAKTI

Key objectives and measures under the scheme include:

1. Strengthening Domestic Production: Encouraging the development and manufacture of high-value biopharmaceuticals within India, reducing reliance on imports, and enhancing India’s position in the global biologics supply chain.
2. Expanding Specialised Human Resources: Establishing three new National Institutes of Pharmaceutical Education & Research (NIPERs) and upgrading seven existing NIPERs to meet the growing demand for skilled professionals in biopharma research, development, manufacturing, and regulation.
3. Building a Robust Clinical Research Ecosystem: Enhancing India’s capabilities to conduct advanced clinical trials by creating a large-scale clinical research infrastructure.
4. Strengthening Regulatory Oversight: Reinforcing the Central Drugs Standard Control Organisation (CDSCO) with a dedicated Scientific Review Cadre to accelerate approvals and ensure globally credible, timely regulatory processes.
5. Fostering Innovation and Startups: Providing early-stage funding and structured equity support to help startups and industry partners advance promising biopharmaceutical candidates from concept through key development milestones.

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Conclusion

Through these measures, Biopharma SHAKTI aims not only to strengthen India’s domestic biopharmaceutical ecosystem but also to make the country a globally recognised leader in biologics and biosimilars, ensuring affordable, high-quality healthcare for its population.

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