India is preparing to spend ₹10,000 crore to build a capability its pharmaceutical industry still lacks: discovering, testing and scaling complex biological medicines.
The government will shortly sanction the Biopharma SHAKTI scheme, retaining India's strength in generic drugs while pushing the industry towards innovation-led biologics, according to a senior official familiar with the matter.
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. It will then invite proposals from industry and industry-academia collaborations, the official said.
The shift reflects a gap in India's pharmaceutical ambitions. Traditional chemical synthesis will remain important, but the rising burden of non-communicable diseases is increasing demand for high-value therapies in immunotherapy, advanced cancer care and weight loss.
India lacks sufficient domestic capacity to take biological drug candidates from discovery through testing and scale-up. Biopharma SHAKTI aims to close that gap and move the country from generic-drug powerhouse towards a larger role in global biologics.
Proposed in the Union Budget 2026–27 with an outlay of ₹10,000 crore over five years, the scheme will support a pipeline of novel biologics and the infrastructure needed to test them.
Biologics are complex medicines made from living organisms; biosimilars are highly similar versions of approved biologic drugs. The government is targeting a 5% share of the global biopharmaceutical market.
The initiative will focus on biologics and biosimilars, including monoclonal antibodies and advanced cellular therapies such as CAR-T. It will also expand India's clinical-trial network and promote electronic health records.
India's biopharma market is valued at approximately $64.5 billion, according to the India Brand Equity Foundation.
Building the pipeline
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, the official said.
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.
“We have held extensive consultations with the industry, academia, government labs, ICMR (Indian Council of Medical Research), DBT (Department of Biotechnology), BIRAC (Biotechnology Industry Research Assistance Council), NIPER (National Institute of Pharmaceutical Education and Research), to assess market needs and incorporated it accordingly in scheme guidelines,” Manoj Joshi, secretary, Department of Pharmaceutical told Mint in an interview.
The government's focus is on the development pipeline, not just manufacturing. Moving a biological drug candidate from discovery to a physical molecule and then through clinical development is far more complex than developing traditional chemical drugs, Joshi said.
Artificial intelligence (AI) may help identify promising candidates, but specialized CRDMOs are still needed to produce test batches, conduct animal safety studies and scale molecules for human trials, he said.
Dr. SK Poddar, consultant surgeon, Pacific OneHealth and president-elect, Delhi Medical Association said, “Biologics are essential for treating serious diseases like cancer, but imported versions are so expensive that most Indian patients simply cannot afford them. When Indian companies make them locally, prices drop sharply and medicines finally reach small towns and villages. This scheme is welcome because instead of depending on one or two foreign firms, 10-20 domestic pharma companies can enter the market. This will bring down treatment costs for patients and give our pharma sector the boost it needed.”
Speed up discovery
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 also be built to make clinical research facility adequately available within the country. We will also support faster drug discovery with adoption of AI and faster clinical trials. Globally it takes 2-3 years for pre-clinical trials to complete. We need to match that,” Joshi said.
The government is also trying to build a broader ecosystem around drug discovery, bringing large pharmaceutical companies, startups, CRDMOs and AI companies into the effort.
“When it comes to manufacturing, it doesn't really matter whether you are manufacturing a biosimilar or an innovative product; the manufacturing plant remains the same,” Joshi said.
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.
The commercial opportunity spans global ambitions and domestic demand. Global innovators see 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.
The government's bet is that targeted funding can close the infrastructure gap and move India beyond low-cost generic copies towards high-value, innovation-driven biological medicines.
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. He said Biocon's investments in R&D, talent and integrated biomanufacturing platforms aligned with the government's priorities and that the company was committed to helping build a globally competitive, innovation-led biopharma sector.