The government is set to invest ₹10,000 crore to strengthen the country’s biopharmaceutical ecosystem and accelerate the transition from a global generic medicines hub to a leading innovator in biologics and biosimilars. The proposed Biopharma SHAKTI scheme aims to build domestic capabilities for discovering, testing and scaling advanced biological medicines. According to Manoj Joshi, Secretary, Department of Pharmaceuticals, the scheme’s operational guidelines are in the final stages and will be released after receiving the necessary approvals, including clearance from the Union Cabinet. Subsequently, the government will invite proposals from pharmaceutical companies as well as industry-academia collaborations.
Bridging India’s Biologics Capability Gap
While India has established itself as one of the world’s largest producers of generic medicines, it still lacks adequate infrastructure and expertise to develop complex biological drugs from discovery to commercial production. The Biopharma SHAKTI scheme seeks to bridge this gap by creating an integrated ecosystem that supports the complete biologics development pipeline. As healthcare demands shift towards advanced therapies for chronic and life-threatening diseases, the initiative aims to position India as a significant player in the global biologics market.
Supporting Next-Generation Therapies
Proposed in the Union Budget 2026-27, the ₹10,000 crore programme will be implemented over five years and will support the development of innovative biologics along with the infrastructure required for research, clinical validation and commercialisation. The scheme will focus on novel biologics, biosimilars, monoclonal antibodies, CAR-T cell therapies and advanced cellular therapies. Additionally, the government plans to expand India’s clinical trial network and promote the adoption of electronic health records to strengthen medical research and patient data management.
Targeting a Larger Share of the Global Biopharma Market
Biologics are sophisticated medicines produced using living organisms, while biosimilars are highly similar versions of already approved biologic drugs. These therapies are increasingly being used to treat cancer, autoimmune disorders, metabolic diseases and other chronic illnesses. With the new initiative, the government aims to secure a 5% share of the global biopharmaceutical market, capitalising on the growing international demand for high-value biological therapies. According to the India Brand Equity Foundation (IBEF), India’s biopharma market is currently valued at approximately $64.5 billion, highlighting significant growth opportunities.
Strengthening CRDMOs and Domestic Research Infrastructure
A key pillar of the Biopharma SHAKTI scheme is the development of India’s Contract Research, Development and Manufacturing Organisations (CRDMOs). These specialised organisations play a critical role in biological molecule synthesis, structural characterisation, preclinical testing, clinical development, process optimisation and commercial-scale manufacturing. Currently, India depends heavily on overseas facilities for advanced synthetic biology capabilities and clinical research. Therefore, the scheme aims to reduce this dependence by supporting domestic CRDMOs through research grants, shared state-of-the-art facilities and partnerships with state governments to reduce infrastructure, power and utility costs.
Industry-Academia Collaboration to Drive Innovation
The Department of Pharmaceuticals has conducted extensive consultations with stakeholders across the pharmaceutical and biotechnology ecosystem while designing the scheme. These consultations included Indian Council of Medical Research (ICMR), Department of Biotechnology (DBT), Biotechnology Industry Research Assistance Council (BIRAC), National Institute of Pharmaceutical Education and Research (NIPER), government research laboratories, pharmaceutical companies and academic institutions. According to Manoj Joshi, the scheme incorporates industry requirements and market needs to ensure that India develops globally competitive biologics research capabilities.
Focus Beyond Manufacturing
Unlike earlier initiatives that primarily encouraged pharmaceutical manufacturing, Biopharma SHAKTI places greater emphasis on the entire drug development lifecycle. Developing biologics involves significantly more complex processes than manufacturing conventional chemical-based medicines. Researchers must identify promising biological molecules, validate their effectiveness, manufacture laboratory batches, conduct animal safety studies and complete multiple phases of human clinical trials before commercial production. The government intends to strengthen every stage of this value chain, enabling Indian companies to move from manufacturing generic medicines to developing innovative biological therapies.
AI to Complement, Not Replace, Drug Development
The government also expects Artificial Intelligence (AI) to accelerate biologics discovery by helping researchers identify promising drug candidates more efficiently. However, officials emphasise that AI alone cannot replace specialised research infrastructure. Advanced CRDMOs will remain essential for producing experimental molecules, conducting preclinical studies, validating safety and efficacy, and scaling biological products for clinical trials and commercial manufacturing.
Positioning India as a Global Biologics Hub
Through the Biopharma SHAKTI initiative, India aims to build a robust innovation ecosystem that supports research, clinical development and commercial manufacturing of advanced biological medicines. As reported by livemint.com, by strengthening domestic capabilities and reducing reliance on overseas facilities, the government seeks to transform India into a global hub for biologics, biosimilars and next-generation biopharmaceutical innovation.
