The global biomanufacturing sector is at a turning point, where companies are looking for ecosystems that offer not only cost advantages but also regulatory clarity, skilled talent and scalable infrastructure. Success today depends on stable policies, globally consistent facilities and predictable intellectual property frameworks. India is well positioned with a strong scientific base, a vibrant startup community and national policies that prioritize biotechnology. There is now a need for a coordinated “soft landing” framework that will enable global companies to enter and grow in India with confidence.
India’s biotechnology landscape has expanded at an extraordinary pace, now home to over 10,000 startups spanning biopharmaceuticals, agri-biotech, industrial biotechnology, healthtech, medtech and bioenergy. This growth reflects both entrepreneurial energy and growing global confidence, evident in continued venture capital flows and increasing opportunities for integration with international supply chains through contract development and manufacturing organizations. The pandemic and changing geopolitics have highlighted the risks of concentrating biomanufacturing capacity in a few regions, giving India a narrow but decisive window to establish itself as a credible hub.
The Department of Biotechnology (DBT) under the Ministry of Science and Technology and its not-for-profit enterprise, Biotechnology Industry Research Assistance Council (BIRAC) have placed high-performance biomanufacturing at the center of national priorities through the BioE3 policy (Biotechnology for Environment, Economy and Employment) approved by the Union Cabinet in August 2024. The policy envisages creating biofoundries, bio-AI centers and thematic centres. bio-based chemicals, smart proteins, carbon capture, cell and gene therapy products, marine and space research, and climate-resilient agriculture, among others. Over the past decade, BIRAC has built one of the world’s most comprehensive ecosystems for biotechnology innovation, effectively linking policy priorities with the needs of industry and academia.
Initiatives such as the Biotechnology Ignition Grant (BIG), the Small Business Innovation Research Initiative (SBIRI), and the Biotechnology Industry Partnership Program (BIPP), as well as the National Biopharma Mission (NBM) supported by the World Bank and Grand Challenges India supported by the Gates Foundation, the India Coalition for Epidemic Preparedness Innovations (Ind-CEPI) working under the global CEPI alliance. Through mission programs such as this, BIRAC has helped ideas move beyond early-stage exploration. Late-stage development in areas such as vaccine development, pandemic preparedness, medical devices, biosimilars, etc. Equity-based mechanisms such as the Sustainable Entrepreneurship and Enterprise Development (SEED) Fund and the Launching Entrepreneurial Driven Affordable Products (LEAP) initiative provide additional capital support. BioNest incubation facilities, e-Youth Centers create an environment where entrepreneurs get access to the infrastructure, expertise and networks needed for growth. Recognizing the importance of regulatory clarity and intellectual property, BIRAC’s IP and Technology Management Cell ensures that innovators receive structured guidance on IP, technology transfer and commercialization. Social innovation programs for products such as the Social Innovation Platform: further expand the reach of biotechnology by supporting affordable and relevant (touch) solutions with direct social impact on social health.
Although these initiatives were not originally designed as formal “soft landing” frameworks, together they already reduce barriers to innovators and show that India is building an interconnected system, supported by BIRAC under DBT, that can be scaled to meet the expectations of global partners.
In the biomanufacturing sector, soft landing is not a shortcut or compromise on standards, but a coordinated ecosystem that reduces uncertainty, costs and risks for international companies setting up operations in India while ensuring alignment with national priorities and broader scientific and economic goals. It provides clarity and predictability from regulatory approval to market entry, allowing companies to focus on innovation and scaling. This framework combines streamlined regulatory pathways, financial incentives such as capital subsidies and R&D tax credits, ready-to-use features, and well-defined IP and licensing guidelines. What sets it apart is that startups, established companies and innovators from outside India can also benefit from government-backed initiatives, including incubation centres, advanced facilities, biofoundries and mentorship networks, to accelerate their market entry and growth. Equally important is support for talent mobility and seamless access to domestic and global markets, enabling confident growth.
India has built a strong and flexible foundation for biomanufacturing, supported by government policies, strategic initiatives and institutional framework, enabling innovators to move confidently from research to industrial scale. Organizations, agencies and mission programs like BIRAC, Research National Research Foundation (ANRF), Department of Science and Technology (DST), Department for Promotion of Industry and Internal Trade (DPIIT), Start-up India and DBT provide structured support through funding, incubation, mentorship and international collaboration, ensuring that scientific talent and entrepreneurial ambitions are supported by practical resources. Programs that nurture startups, strengthen the entrepreneurial pipeline, and facilitate technology transfer have created a strong ecosystem, while India’s demographic advantage provides a large pool of skilled professionals to sustain innovation and growth.
Global examples provide India with practical lessons on building a resilient biomanufacturing ecosystem. Singapore demonstrates how careful coordination, clear regulations, reliable infrastructure and targeted talent development can attract multinational pharmaceutical investment, such as Pfizer’s state-of-the-art Active Pharmaceutical Ingredient (API) facility at Tuas Biomedical Park. In July 2024, Pfizer expanded the facility with $743 million to produce small molecule APIs for oncology, pain management and antibiotics, creating a sustainable hub driven by strategy rather than incentives alone.
The US highlights the importance of long-term, sustained support. Following the 2022 Bioeconomy Executive Order, federal funding for research, development, and industrial scale increased from $2.7 billion to more than $3.5 billion, showing that continued investment is critical to building effective ecosystems on a global scale. The UK reflects the need to balance rapid innovation with rigorous security and governance. Its 2023 Biosafety Strategy, supported by a £1 billion National Biosafety Centre, ensures accelerated production without compromising standards, while maintaining public trust. Meanwhile, despite huge progress, China offers a cautious perspective: massive infrastructure and incentives have expanded capacity, but inconsistent intellectual property enforcement has at times limited global confidence, proving that scale alone does not guarantee sustainable leadership.
Also demonstrates the value of global collaboration networks. The Global Biofoundry Alliance, which launched in 2018 with 15 founding members, has now grown to 40 biofoundries worldwide. Building on this momentum, India has launched 21 advanced bio-manufacturing hubs under the BioE3 policy to grow its bio-economy and accelerate innovation across sectors. This initiative sets a benchmark for other countries and strengthens India’s unique, visionary position in the global biomanufacturing landscape.
As India’s biomanufacturing sector grows, trust is key to sustainable progress. Maintaining high standards of biosafety and biosecurity protects public health and reassures global partners. Strong and well-articulated regulatory guidelines, environmental rules, consistent intellectual property protection and reliable dispute resolution are equally important. Beyond compliance, the goal is to have a transparent and predictable system that provides accessible and affordable infrastructure, exclusive facilities and a supportive ecosystem, so startups, innovators and investors alike feel confident that India is a responsible and trustworthy destination for cutting-edge biomanufacturing.
India has all the ingredients to become a global leader in biomanufacturing. There is a need for a coordinated “soft landing” approach that provides clarity and confidence to startups and innovators. Aligning regulations, offering targeted incentives, providing access to world-class infrastructure and protecting intellectual property can attract investment, expand capacity, create quality jobs and strengthen global resilience. With timely, well-coordinated action, this potential can translate into a lasting impact on the world stage.
This article is written by Dr. Jitendra Kumar, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC).
