The Union Budget 2026 has announced BioPharma SHAKTI, a new national programme with an outlay of ₹10,000 crore over five years to strengthen India’s biologics and biosimilars manufacturing ecosystem.
The programme focuses on expanding domestic capability beyond conventional small-molecule generic medicines and building capacity in complex biological drugs. As part of the initiative, three new campuses of the National Institute of Pharmaceutical Education and Research (NIPERs) will be established, while seven existing NIPERs will be upgraded with advanced infrastructure dedicated to biologics research and development.
The programme is structured around research capacity, clinical trial infrastructure and regulatory modernisation for biopharmaceutical products.
Expansion of Clinical Trial Infrastructure and Regulatory Upgrades
BioPharma SHAKTI provides for the creation of 1,000 accredited clinical trial sites across the country to support drug development and testing for complex biological products.
At present, India’s clinical trial infrastructure for advanced therapeutics remains concentrated in large metropolitan centres. The new network is intended to expand trial capacity beyond tier-I cities and enable faster patient recruitment for multicentre studies.
The programme also includes the modernisation of the Central Drugs Standard Control Organisation (CDSCO). The regulatory upgrade is aimed at aligning approval processes for biologics and biosimilars with internationally accepted regulatory standards.
Current approval timelines for complex biologics in India typically range between 12 and 18 months. The revised regulatory framework targets review timelines comparable with major international regulators, in the range of 6 to 12 months.
Focus on Non-Communicable Disease Therapies
The programme is aligned with the growing demand for biological therapies driven by India’s non-communicable disease burden.
India has more than 101 million adults living with diabetes, and reports around 1.4 million new cancer cases annually. Autoimmune disorders also account for a significant and growing patient population. Treatments for these conditions increasingly rely on biological medicines such as monoclonal antibodies, insulin analogues and gene-based therapies.
India currently imports more than 90 percent of its biologics requirements. BioPharma SHAKTI is intended to build domestic manufacturing capability for high-value biological products in order to reduce import dependence and improve local availability.
Positioning for the Global Biosimilars Market
The programme also seeks to support India’s participation in the global biosimilars market, which is projected to expand sharply by 2030. Indian pharmaceutical companies currently hold a strong share in global generic medicines but a relatively small presence in biologics and biosimilars manufacturing.
BioPharma SHAKTI is designed to create the research, clinical development and regulatory infrastructure required to support large-scale biologics production and global regulatory filings.
Implications for Clinical Research and Manufacturing Enterprises
The planned network of 1,000 clinical trial sites is expected to support contract research organisations and multinational clinical sponsors by expanding patient access and reducing site capacity constraints.
For manufacturing and development partners, the upgraded NIPER infrastructure is intended to provide local capabilities for biologics process development and analytical testing. The regulatory upgrades at CDSCO are aimed at improving predictability of approval timelines for biologics and biosimilars developed and manufactured in India.
BioPharma SHAKTI establishes a national framework for research capacity, clinical development and regulatory readiness for biologics manufacturing under Budget 2026.
