The Government of India on February 02, 2026, proposed the Biopharma SHAKTI in the Budget 2026-27 Series.
The Union Budget 2026–27 marks a decisive shift in India’s approach to pharmaceuticals by placing biopharma and biologic medicines at the centre of its healthcare and manufacturing strategy. This aligns with the Government of India’s vision of transforming India into a leading global biopharma industry and capturing 5% of the global biopharmaceutical market share.
Biopharma involves production, manufacturing, or extraction of therapies through biological organisms, such as human cells, fungi, or microbes. Some examples of biopharmaceuticals include vaccines, antibody treatments, gene therapies, cell implants, modern insulin, and recombinant protein drugs.
The Key Budget Announcements for Biopharma:
• Launch of Biopharma SHAKTI, a dedicated national initiative with an outlay of Rs. 10,000 crores over five years, aimed at strengthening India’s end-to-end ecosystem for biologics and biosimilars. The initiative is designed to support domestic development and manufacturing of high-value biopharmaceutical products and medicines, reduce import dependence, and enhance India’s competitiveness in global biologics supply chains.
• Expansion and strengthening of the Biopharma-focused network through the establishment of three new National Institutes of Pharmaceutical Education and Research (NIPERs) and the upgradation of seven existing NIPERs. This measure seeks to address the growing requirement for highly specialised human resources in biopharma research, development, manufacturing and regulation.
• Creation of a large-scale clinical research ecosystem, with a proposal to develop over 1,000 accredited clinical trial sites across the country. This is expected to significantly improve India’s capacity to conduct advanced clinical trials for biologics and biosimilars, accelerating innovation, and positioning the country as a preferred global destination for ethical, high-quality, and efficient clinical trials.
• Strengthening of the regulatory framework for biologics, including enhancing the capacity of the Central Drugs Standard Control Organisation (CDSCO) through the induction of specialised scientific and technical personnel. The focus is on improving regulatory efficiency, aligning approval timeframes with global standards, and enabling faster evaluation of complex biopharmaceutical products.
[Release ID: 2222079]
