Biopharma SHAKTI

Why in News?
Union Budget 2026–27 announced Biopharma SHAKTI, a ₹10,000 crore mission over five years to develop India as a global biopharma manufacturing hub, with focus on biologics and biosimilars.
Objective : To build a complete domestic ecosystem for development, manufacturing, clinical testing and regulation of biologics and biosimilars, and to position India as a global biopharma manufacturing hub with a target of capturing 5% of the global market.
Components of the Initiative :
Human Resource Development
•    Establishment of three new NIPERs and upgradation of seven existing NIPERs.
•    Aims to build highly skilled manpower in biopharma research, manufacturing and regulation.
Clinical Research Ecosystem
•    Development of over 1,000 accredited clinical trial sites across the country.
•    Enhance India’s capacity for advanced clinical trials in biologics and biosimilars.
•    Position India as a global hub for ethical and high-quality clinical research.
Regulatory Strengthening
•    Strengthening of CDSCO through induction of specialised scientific and technical personnel.
•    Improve regulatory efficiency and aligns approval timelines with global standards.
•    Enable faster evaluation of complex biopharmaceutical products.
Expected Outcomes of Biopharma SHAKTI
•    The initiative will strengthen domestic development and manufacturing of high-value biopharmaceutical products.
•    It will reduce India’s import dependence on advanced biologics and biosimilars.
•    The scheme will enhance India’s competitiveness in global biologics supply chains.
•    It is expected to boost exports of high-value biopharma products.
•    The initiative will support long-term public health needs while contributing to economic growth.