India Unlimited 3.0: Experts say India has the Talent, Tech, and Trust to lead the future of biopharma

New Delhi: The industry leaders and policymakers came together to discuss how India is strengthening its global footprint in biologics at the third edition of ‘India Unlimited 3.0’ event organized by the International Contract Pharma Association (ICPA) in Boston on June 15, 2025. The event was held on the sidelines of BIO International Convention 2025 and was the 3^rd in the series that began in 2022 in San Diego.

Dr. Anil Ram Chauhan, Founder Director, ICPA appreciated all sponsors, supporters, attendees and welcomed them to deliberate on India’s growing role in global Biopharma.

The experts discussed everything from cell and gene therapies to biosimilars and next-gen manufacturing platforms. Their consensus: India’s biologics engine is ready for the world stage—and the momentum is only growing.

The first session, ‘India’s growing global footprint and prowess in Biologics’ was moderated by Pushpa Vijayaraghavan, Director – Healthcare & Lifesciences advisory, Sathguru Consultants who highlighted India’s growing momentum in biologics, driven by long-standing investments in biosimilars and an expanding opportunity in CDMO and CRO services. “As the global demand for affordable biologics rises, India is well-positioned to serve both discovery and manufacturing needs,” she noted.

Pushpa emphasized the government’s strong policy push, particularly the Bio-E3 initiative under the bioeconomy vision of achieving $300 billion by 2030. “There’s a clear focus on biomanufacturing—from green chemistry to therapeutics and applications across agriculture, food, and industrial biotech.” She also stressed the need for regulatory reforms: “India’s biosimilar guidelines, though progressive in their time, need alignment with global norms that reduce in vivo testing and prioritize analytical similarity. The draft regulatory updates now under review promise greater capital efficiency and could accelerate investment.”

She concluded by noting the dual momentum—established players expanding global capacity, and startups innovating in areas like RNA, cell and gene therapy, and advanced biologics manufacturing.

Dr. Jitendra Kumar, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC), emphasized India’s strategic commitment to nurturing biotech innovation through the Department of Biotechnology and its dedicated arm, BIRAC. “Unique among government bodies, BIRAC directly funds startups, from ideation to commercialization through programs like the Biotechnology Ignition Grant (BIG) and supports them via a robust network of over 100 BIONEST incubation centers across the country. BIRAC’s comprehensive support ecosystem: early-stage funding, lab access, scaling support, venture capital facilitation, and regulatory guidance, especially in emerging areas like biosimilars, medical devices, and biomanufacturing.”

However, Dr Kumar flagged two key challenges: the lack of pilot-scale GMP facilities for scale-up and limited early-stage venture capital within India, leading to startups seeking funding overseas. Highlighting India’s Bio-E3 policy, Dr. Kumar stressed the critical role of bio-manufacturing in driving future growth across sectors such as therapeutics, agriculture, carbon capture, and industrial biotech. BIRAC is now funding biofoundries and biomanufacturing hubs with grants of up to Rs 70 crore to spur innovation and scale.

He called for stronger global collaboration and more MNCs to manufacture in India, referencing BIRAC’s recent LOI with Germany’s Miltenyi Biotec as a key milestone. “To succeed globally, India must not only build capacity but also attract global players with world-class infrastructure, talent, and policy support,” he concluded.

John Glavas, AVP External Manufacturing – Large Molecule Global Partnerships, Merck shared that the pandemic exposed the fragility of global supply chains, prompting a shift toward securing critical manufacturing, particularly for complex biologics.

“If we look back five to six years during the COVID crisis, the urgent need for local vaccine production highlighted the fragility of global supply chains. It triggered a global rethink on how to secure critical manufacturing capabilities—vaccines being a key focus at the time. At Merck, like many others, we began evaluating our supply chains to identify improvement opportunities. Fast forward to 2025, with a new ‘U.S.-for-U.S.’ manufacturing approach gaining traction, Merck is continuing to invest in US manufacturing that can produce and distribute products close to patients right here in the US.   This doesn’t mean ending overseas production but rather incorporating a stronger domestic manufacturing component.   Glavas noted that with supply chain constraints expanding across the globe accompanied by growing demand, India has positioned itself well with its skilled labor and scalable manufacturing.  The country offers an additional choice for companies that are looking to expand their networks and securing those critical manufacturing capabilities.”

Russ Miller, VP, Sales and Marketing, Enzene Biosciences provided a detailed overview on the initiatives being undertaken by his company.

“At Enzene, we initially entered the biosimilars space but quickly realized that competing with established players like Samsung wouldn’t drive meaningful differentiation. Instead, we focused on innovation and developed a fully connected continuous manufacturing platform, Enzene X, which enables small bioreactors to outperform traditional large-scale fed-batch systems. For example, a 500L bioreactor using our technology can match or exceed the output of a 3x2KL fed-batch setup, and our next-gen 1,000L system rivals a 20KL batch plant.”

Miller added further, “India is still early in establishing itself as a biologics hub, and there’s significant room for both traditional and innovative approaches to scale up. We also invest in workforce development through our in-house training academy, and we see it as a win for the industry when our trainees contribute across the ecosystem. “At Enzene, we have our own training academy where we bring folks in out of college, and we train them. And at the end of the day, if those folks go through our training and go to another company, awesome. That is absolutely awesome, because it enhances the overall ecosystem of talent.”

Dr Prabuddha Kundu, Co-Founder and MD, Premas Biotech explained the latest developments at his company. “At Premas, we took a reductionist, efficiency-first approach to biologics by applying lean manufacturing principles—initially bringing in a steel industry veteran to identify inefficiencies in R&D. Despite early resistance from scientists, this approach helped us streamline CMC processes, significantly cutting timelines—from 24 months to just 8–9 months in some cases. One major success was with Oramed, where we used our model to scale protein production from 50g to 105kg/week—eventually enabling tech transfer to a manufacturing facility in China. 

Dr Kundu added further: “During COVID, we further innovated by engineering yeast to produce circular RNA inside cells, effectively combining RNA and LNP processes within one organism. This resulted in dramatically lower costs—down to just two meals per dose for a rotavirus vaccine. Our focus has always been on rethinking processes to drive scale, speed, and affordability—not cost arbitrage, but practical innovation.”

Dr Kundu also highlighted the importance of TRD, Trust, Regulatory compliance and Data integrity, that all companies want to ensure while outsourcing their projects.

Biologics Beyond Borders: India Builds a Global Bio-Pharma Reputation

The second session of the event titled, ‘Servicing global research, discovery, development, and manufacturing requirements’ was moderated by Dinesh Jain, Founder CEO, AAGAMI INC. who shared his insights on the company’s experience. 

“At Aagami Inc., we’ve supported numerous global CRO and CDMO projects, strategic partnerships, and cross-border collaborations—especially between India, Japan, and the U.S. Drawing on deep regional expertise, we help bridge cultural and regulatory gaps in global life sciences. Our in-house research shows India is already the second-largest destination for contract research and manufacturing, driven by FDA-compliant facilities, cost advantages, and a growing biologics capacity. With a 14.7% CAGR in India’s CDMO market—far outpacing the U.S. and China—the country offers both scale and innovation. We’ve mapped over 100 CRO/CDMO companies across major hubs like Hyderabad, Mumbai-Pune, Bangalore, and NCR, reflecting a balanced and mature ecosystem. India’s growing strategic importance is also reflected in the rise of global capability centers and partnerships—like Celltrion, Zydus, Aragen, and Enzene—building facilities and entering JVs across the country. With strong government support and investor interest, India is fast emerging as a global life sciences powerhouse.”

Dhananjay Kumar Tiwary, Advisor, Department of Biotechnology, Government of India Senior Fellow, School of Public Health, Brown University stated: “India’s bioeconomy has grown 16-fold over the past decade , from $10 billion in 2014 to $165 billion in 2024, with a target of $300 billion in 2030. This progress reflects a convergence of supportive policies, schemes, and a thriving innovation ecosystem. With over 10,000 biotech startups and 100 incubators across the country, India has rapidly evolved from generics to next-gen biologics—developing homegrown CAR-T cell therapies, DNA vaccines, and gene-editing solutions.”

Tiwary added further: “Building on this momentum, the BioE3 policy (Economy, Environment, Employment) is expanding India’s capabilities through bio-manufacturing hubs and upcoming Bio-AI hubs. These initiatives aim to integrate AI in biology, develop large language models for life sciences, and offer open access to computational tools. Strategic manufacturing of critical reagents near bio hubs will ensure supply chain resilience and cost efficiency. India is also investing in talent, producing millions of STEM graduates and thousands of bioscience PhDs. Projects like the Indian Genome Initiative (10,000 human genomes sequenced) promise to transform healthcare and personalized medicine. India invites global players to co-create, partner, and scale in this vibrant biotech landscape.”

Priya Kapoor G. Hingorani, MD, Miltenyi Biotec India, and VP Southeast Asia Clinical Business said, “Miltenyi Biotec, founded in 1989 in Germany, is built on a culture of innovation, starting with the world’s first cell separation technology. Now present in over 70 countries with more than 20,000 products, the company leads in cell and gene therapy, including CAR-T, graft engineering, and autoimmune disorder treatments. Our Clinimax Prodigy system offers a closed, end-to-end solution for manufacturing cell therapies, ensuring trust, quality, and innovation. We operate two arms: Biotech (machines and reagents) and Biomedicine (cell and gene therapy products). Our impact spans liquid and solid tumors, neurological and rare diseases.”

“A key reason for our presence in India is its potential in biotech innovation and manufacturing. Since launching in 2024, we’ve achieved milestones like an LOI with THSTI and the Miltenyi Innovation and Training Center in Hyderabad to upskill talent. We’re also working on Phase 2 trials for liquid tumors, with aspirations to make India a hub for cutting-edge therapies. Miltenyi is committed to building local capacity, enabling access, and transforming patient lives—just as we’ve already seen globally.”

Rahul Singhvi, CoFounder, RESILIENCE shared insights from his journey—from IIT Kanpur to building major biotech ventures in the U.S., including Novavax and Resilience. “I was born and raised in India and educated in India, so very fortunate to have gotten to one of the best institutions in India, and IIT Kanpur. I moved to the U.S. in 1987, and I got a Ph.D. from MIT. And during one of my journeys, I was the CEO of Novavax, a company that you’ve probably heard of. It’s a company that played a role in the COVID pandemic. And most recently, I’m building a new CDMO.”

He highlighted India’s untapped potential in biotech, especially in light of shifting geopolitical dynamics and reduced Western reliance on China. “My first impactful experience with India came in 2008 when Cadila Pharmaceuticals invested $11M in Novavax during a financial crisis, helping save the company. This sparked his belief in India’s capabilities and resilience.”

Singhvi emphasized India’s strengths: world-class talent, cost-effective manufacturing, and national policy support. To become a global leader, as previously suggested by Dr Prabuddha Kundu in the first session, India must focus on TRD – Trust, Regulatory compliance, and Data integrity—and set global standards.

Finally, he called for India to leverage AI to leapfrog traditional players like Wuxi, using a model akin to Airbnb—optimizing underutilized infrastructure with top talent and digital tools.

Dr Mahesh Bhalgat, Group CEO & MD, Veeda Lifesciences , shared his journey from working in the U.S. on early antibody-drug conjugates over 30 years ago and returning to India 15 years ago, affirming India’s rising role in global life sciences. He emphasized India’s readiness to meet global pharma demands end-to-end, provided there’s continued adoption of tech, regulatory strengthening, and public-private ecosystem growth.

“Today, we have a very large CRO-CDMO sector. The advantage of this sector being part of the Indian ecosystem is that these companies work in the space of new discovery and development. As compared to the generic companies of India these CRDMOs provide complementarity of skills, which if you’re not harvesting, then we are actually doing ourselves a disservice. India has been making waves in digital technology, infrastructure, generics volume, but one place that we don’t see India at the top is pharma innovation. As compared to nations that lead in innovation, India stands out differently because we expect at a lot more government support, and in reality, the Indian private sector should also spend more for discovery research.”

Dr Bhalgat highlighted India’s strong CRO-CDMO sector, vast talent pool, and improving infrastructure, noting a shift from volume to value driven by innovation. CROs and CDMOs are now actively working on ADCs, mRNA, and CAR-Ts, and can shorten time to market, helping de-risk global portfolios. “Veeda itself has transitioned from a generic-focused CRO to a global, innovation-led organization—acquiring a European company, expanding into large molecules, and running clinical trials in 26 countries, including a major 1,500-patient multiple myeloma trial.

The India Unlimited 3.0 that was sponsored by BIRAC, Enzene Biosciences, Merck Limited and Premas Biotech received an overwhelming response from the stakeholders. 

The event was supported by Miltenyi Biotec, Aagami, Veeda Lifesciences, and Sathguru Consultants.

The next edition, India Unlimited 4.0 is planned for June 21, 2026 in San Diego as an affiliate event of BIO 2026.

BioVoice News was the official media partner of the event.