India is preparing to spend ₹10,000 crore to build a capability its pharmaceutical industry still lacks: discovering, testing and scaling complex biological medicines. According to reports from Mint, the government will shortly sanction the Biopharma SHAKTI scheme, retaining India's strength in generic drugs while pushing the industry towards innovation-led biologics. The scheme's operational guidelines are in the final stages and will be released by the Department of Pharmaceuticals after necessary approvals, including from the Union cabinet. As per a senior official familiar with the matter, the scheme will then invite proposals from industry and industry-academia collaborations to build the research, clinical-trial and manufacturing ecosystem needed to move from low-cost generic copies to high-value biological medicines.
The initiative will focus on biologics and biosimilars, including monoclonal antibodies and advanced cellular therapies such as CAR-T. As reported by Mint, the government is targeting a 5% share of the global biopharmaceutical market. India's biopharma market is valued at approximately ₹64.5 billion, according to the India Brand Equity Foundation. The scheme will support a pipeline of novel biologics and the infrastructure needed to test them, with the government proposing it in the Union Budget 2026–27 with an outlay of ₹10,000 crore over five years. The shift reflects a gap in India's pharmaceutical ambitions, with traditional chemical synthesis remaining important but the rising burden of non-communicable diseases increasing demand for high-value therapies in immunotherapy, advanced cancer care and weight loss.
A key intervention will be in Contract Research, Development, and Manufacturing Organizations (CRDMOs), which handle biological synthesis, characterization, testing, de-risking and scale-up through pre-clinical and clinical research. According to Mint, India currently relies largely on expensive external sources for deep synthetic and structural biology capabilities and, often, clinical trials. Biopharma SHAKTI will seek to reduce that dependence through research grants, shared state-of-the-art facilities and partnerships with state governments to lower input, power and utility costs. As Manoj Joshi, secretary of the Department of Pharmaceutical, told Mint, extensive consultations were held with industry, academia, government labs, ICMR, DBT, BIRAC, NIPER to assess market needs and incorporate them accordingly in scheme guidelines.
The government also plans to streamline medical regulations around core safety concerns, with the aim of helping domestic innovators move molecules into clinical development more efficiently. Under this scheme, a network of 1,000 clinical trial centres across India will be built to make clinical research facility adequately available within the country. The government is also supporting faster drug discovery with adoption of AI and faster clinical trials, with the aim of matching the global standard of 2-3 years for pre-clinical trials. As Joshi explained to Mint, when it comes to manufacturing, it doesn't matter whether you are manufacturing a biosimilar or an innovative product - the manufacturing plant remains the same. The distinction is central to the government's strategy: India needs to build discovery and development capabilities, while its existing manufacturing base can support both biosimilars and innovative products.
Welcoming the initiative, Shreehas Tambe, chief executive and managing director of Biocon Ltd, said the scheme addresses key gaps across India's biologics and biosimilars value chain—from expanding the development pipeline and clinical-trial infrastructure to improving regulation and workforce skills. According to Mint, Biocon's investments in R&D, talent and integrated biomanufacturing platforms aligned with the government's priorities, and the company was committed to helping build a globally competitive, innovation-led biopharma sector. Tambe emphasized that while AI may help identify promising candidates, specialized CRDMOs are still needed to produce test batches, conduct animal safety studies and scale molecules for human trials. The commercial opportunity spans global ambitions and domestic demand, with global innovators seeing India as a potential market for high-cost therapies as purchasing power rises, while demand at home remains strong for affordable, off-patent cancer medicines and insulin.
