The Government of India has launched the Biopharma SHAKTI scheme with a financial outlay of ₹10,000 crore over five years, aimed at strengthening the country’s capabilities in biologics and biosimilars. The initiative seeks to enhance domestic manufacturing, foster innovation, and position India as a competitive global player in the biopharmaceutical sector.
Addressing the Rising Disease Burden
India is experiencing a growing prevalence of non-communicable diseases such as diabetes, cancer, and autoimmune disorders. Biologic therapies are increasingly critical in managing these conditions, offering improved treatment outcomes and quality of life. The scheme is designed to ensure wider access to such advanced therapies while reducing dependence on imports.
Key Objectives of the Scheme
- Boosting Domestic Manufacturing
The initiative focuses on promoting local production of high-value biopharmaceutical products, strengthening India’s role in the global supply chain and enhancing self-reliance.
- Expanding Skilled Workforce
The government plans to establish three new National Institutes of Pharmaceutical Education & Research (NIPERs) and upgrade seven existing institutes. This will help address the growing demand for skilled talent across research, manufacturing, and regulatory functions.
- Strengthening Clinical Research Infrastructure
The scheme aims to build a robust clinical research ecosystem, enabling large-scale and advanced clinical trials within the country.
- Enhancing Regulatory Capabilities
Regulatory oversight will be reinforced through capacity building at the Central Drugs Standard Control Organisation (CDSCO), including the creation of a specialised scientific review framework to accelerate approvals and ensure global compliance standards.
- Promoting Innovation and Startups
The scheme includes provisions for early-stage funding and structured equity support to encourage startups and industry participants to develop and scale biopharmaceutical innovations.
Strategic Impact
By integrating manufacturing, talent development, research infrastructure, and regulatory efficiency, the Biopharma SHAKTI scheme aims to create a comprehensive ecosystem. This is expected to improve affordability and accessibility of advanced therapies while strengthening India’s position in the global biopharma landscape.
Summary
The Biopharma SHAKTI scheme, backed by a ₹10,000 crore allocation, is a strategic initiative to boost India’s biologics and biosimilars ecosystem. It focuses on domestic manufacturing, skill development, clinical research, regulatory strengthening, and innovation support, with the broader goal of enhancing healthcare access and establishing India as a global biopharmaceutical hub.
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