Picture this: A cancer patient in a district hospital, once sent abroad for care, now begins treatment with cell therapy—developed and produced just a few hours away, in a domestic biomanufacturing facility. No loud declarations, no sweeping claims–just the quiet signal of a new capability taking root, as India steadily builds a biomanufacturing future from the ground up.
India’s strength in pharmaceuticals is well known–but what’s unfolding now goes beyond low-cost generics and vaccines. With promising advances like the recent approval of India’s first indigenous CAR-T cell therapy and successful early-stage gene therapy trials for haemophilia, India is carving out a leadership role on the global stage of biologics.
But seizing this opportunity is not guaranteed. It depends on how we build the path ahead. India has the ingredients—future-ready talent base, manufacturing infrastructure, and supportive government initiatives like the Production Linked Incentives and the BioE3 policy. These have laid the foundation, but rising as a leader will demand more: coordination, bold investment, and a focus on capabilities that secure long-term advantage.
What could make the difference?
First, shaping leadership on two interconnected fronts will be essential: building capacity for next-generation biologic modalities and securing access to the inputs that power them. These biologics–such as cell and gene therapies, monoclonal antibodies, antibody-drug conjugates, and nucleic acid-based treatments–depend on a precise, fast-evolving suite of components. These include everything from expression vectors and viral plasmids to single-use bioprocess components, engineered cell lines, chemical delivery systems, chromatography resins, cytokines, custom enzymes, and purification reagents. A missing reagent or delayed shipment doesn’t just slow down a process; it can ground an entire production line. Building production capacity of these inputs—especially near biomanufacturing hubs–will be key to ensuring supply security, operational resilience, lower costs, and faster development timelines. It also advances national self-reliance and positions India as a promising friend-shoring destination for global partners away from high-risk geographies.
Second, every stride in biomanufacturing hinges on infrastructure built to enable it. Modular, purpose-built GMP facilities form the backbone of biologics and reagent production. When infrastructure opens its doors, ideas move faster, risks shrink, and the entire biomanufacturing ecosystem grows stronger.
Third, new era of biomanufacturing is taking shape—driven by Artificial Intelligence (AI), Machine Learning (ML), robotics, and automation. At its core are large biological language models (LBLMs) reshaping how we engineer biology. Trained on vast biological and process-specific datasets, these AI models and tools are accelerating discovery and transforming bioprocessing—from identifying drug targets and designing novel proteins to optimising leads and streamlining workflows for more scalable, reliable, and error-free production.
Fourth, talent will be the X-factor—biomanufacturing’s future turns on a specialised workforce trained at the intersection of engineering biology, synthetic biology, bioprocessing, and AI, ML and LBLM.
Finally, as advances in engineering biology, synthetic biology, and AI redefine how biologics are discovered, developed, and produced, regulatory systems must evolve too. An agile framework that keeps pace with scientific progress–while aligning with global standards for safety, quality and reliability–can accelerate innovation cycles, increase trust in products, and strengthen the global competitiveness of the biomanufacturing ecosystem.
How do we take the lead?
Advance and expand future-ready biomanufacturing platforms by supporting both the development of new purpose-built modular facilities and the repurposing of existing biopharma infrastructure through phased adaptation of suitable components. These facilities should function as shared public-private platforms—ensuring sustainability and broad access for start-ups, Contract Development and Manufacturing Organisations (CDMOs), transitioning biomanufacturers, and entrepreneurs relocating operations.
Localise supply chains by establishing domestic production capacity for critical reagents and materials within priority manufacturing zones, while incentivising biopharma companies and start-ups to enter this space through targeted support schemes and investment-friendly policies.
Establish centralised bio-AI infrastructure through institutionally anchored platforms that give developers access to high-performance computing, well-curated biological datasets, and secure cloud environments. These platforms should serve as national enablers—coordinating with start-ups, pharma companies, CDMOs, and academic partners to collaboratively develop AI models and tools suited to biomanufacturing needs —ranging from models for protein design to simulation tools for optimising cell culture, purification, and quality control.
Once in place, this same digital backbone can also support building and deploying AI agents to augment human operation across the biomanufacturing pipeline —from fine-tuning bioprocess conditions and flagging inconsistencies to automating regulatory documentation and forecasting supply needs, these intelligent systems can enhance speed, quality, and consistency throughout production and compliance workflows.
Cultivate a robust and future-ready talent pipeline through interdisciplinary training, upskilling programmes, curriculum reforms—supported by strong academia-industry collaboration—at the interface of advanced biomanufacturing disciplines and AI-integrated platforms. Prioritise initiatives for targeted hiring—including efforts to attract Indian postdoctoral researchers and professionals abroad who are seeking meaningful opportunities to return.
Invest in scaling domestic capabilities through targeted government instruments such as viability gap funding, low-interest loans, and innovation-linked incentives that reduce early-stage risk. Identify and support entities with the capacity and potential to deliver high-impact products at scale.
Modernise regulatory systems to enable risk-proportionate approval pathways, ensure globally benchmarked product quality, enhance biosafety and biosecurity protocols, and achieve world-class compliance to build international product credibility and drive market leadership.
With key initiatives already in motion under BIoE3 policy spearheaded by the Department of Biotechnology, pharma companies, CDMOs, and innovators must now build on this momentum—moving beyond legacy products to invest in high-value areas like advanced biologics and critical reagent production. The opportunity is here; the sector is ready. It’s time to lead.
This article is authored by Dhananjay Kumar Tiwary, Senior Fellow, Brown University, US, and on leave from his position as adviser to the Department of Biotechnology, Government of India.
