New Delhi, Feb 2 (.) The union Budget 2026–27 has signalled a decisive policy shift by placing biopharmaceuticals at the core of India’s healthcare and manufacturing strategy.
With the announcement of the Biopharma SHAKTI initiative, backed by an outlay of Rs 10,000 crore over five years, the government aims to transform India into a leading global hub for biologics and biosimilars and secure 5 per cent of the global biopharmaceutical market.
The Budget acknowledges the growing burden of non-communicable diseases such as cancer, diabetes, and autoimmune disorders, alongside the increasing global reliance on biologic medicines.
By prioritising biopharma, the government is seeking to move India up the pharmaceutical value chain from being primarily a cost-efficient producer of generic drugs to a centre for innovation-driven, high-value therapies.
Under the Biopharma SHAKTI initiative, the government plans to strengthen the entire ecosystem for biologics and biosimilars. This includes support for domestic research, development, and manufacturing of complex products such as vaccines, therapeutic proteins, gene therapies, and biosimilars, while reducing dependence on imports and enhancing India’s competitiveness in global supply chains.
A key focus area is human resource development. The Budget proposes the establishment of three new National Institutes of Pharmaceutical Education and Research (NIPERs) and the upgradation of seven existing NIPERs to address the rising demand for highly specialised skills in biopharma research, manufacturing, regulation, and quality control.
To accelerate innovation and clinical validation, the government has also proposed creating a large-scale clinical research ecosystem, including the development of over 1,000 accredited clinical trial sites across the country.
This move is expected to significantly enhance India’s capacity to conduct advanced clinical trials for biologics and biosimilars and position the country as a preferred global destination for ethical, high-quality, and cost-effective clinical research.
Regulatory reforms form another pillar of the Budget’s biopharma strategy. The Central Drugs Standard Control Organisation (CDSCO) will be strengthened through the induction of specialised scientific and technical personnel, with the aim of improving regulatory efficiency, aligning approval timelines with global standards, and enabling faster evaluation of complex biopharmaceutical products.
The latest measures build on existing government initiatives such as the National Biopharma Mission (Innovate in India – i3), launched in 2017, which has supported over 100 projects involving more than 150 organisations and multiple MSMEs.
The mission has played a catalytic role in nurturing biotech startups, supporting indigenous development of vaccines, biosimilars, diagnostics, and medical devices, and creating jobs and clinical research infrastructure across the country.
The convergence of investments in manufacturing, skilled manpower, clinical research capacity, and regulatory credibility reflects a coordinated long-term vision.
As global demand for biologics continues to rise, the Biopharma SHAKTI initiative is expected to improve domestic access to advanced and affordable therapies while reinforcing India’s ambition to emerge as a globally competitive biopharma manufacturing and innovation hub.
. VK VAN .