India’s role in the global biotech ecosystem is changing. For years, the India-US relationship was often viewed through the lens of cost efficiency and execution. But as biotech programmes demand faster development, deeper scientific capabilities and greater flexibility, that equation is becoming more nuanced.
The opportunity is no longer simply about moving development or manufacturing activities to a lower-cost geography. It is about connecting India’s scientific, development and pharmaceutical manufacturing capabilities with the US innovation ecosystem much earlier in the development cycle.
To explore how this operating model is evolving, we spoke with Mr. Venkat Nelabhotla, Co Founder, President & CEO, Vyome Holdings Inc. In this conversation, he discusses what a more integrated India-US model could mean for biotech development, from discovery support, formulation and analytical development to CMC, clinical development and manufacturing. He also looks beyond cost as a measure of value, examining technology transfer, modular infrastructure, quality and data integrity, capital efficiency, and the organisational conditions that distinguish a strategic partnership from a transactional one.
1. US biotech programmes increasingly need speed, technical depth and flexibility alongside cost efficiency. Where do you see the strongest opportunities for India to add value across the biotech development and manufacturing lifecycle?
I think we need to move away from looking at India primarily as a cost arbitrage destination.
Cost is certainly an advantage, but it is no longer the most interesting part of the story. India today has significant scientific talent, strong chemistry and formulation capabilities, clinical development experience and one of the deepest pharmaceutical manufacturing ecosystems in the world. The opportunity is to bring these capabilities into the innovation cycle much earlier. Discovery support, formulation development, analytical development, CMC, clinical development and manufacturing can increasingly be integrated across India and the US.
The US brings a very strong innovation ecosystem, access to capital, global clinical development experience and sophisticated regulatory pathways. India brings scientific depth, execution capability and the ability to do high quality development with significantly greater capital efficiency. When these strengths are integrated properly, the result is not simply lower cost. It can mean faster development, more experiments for the same capital and ultimately a higher probability of bringing innovation to patients.
That is what I mean when I talk about the US India Innovation Corridor.
2. Technology transfer between countries is often treated as a technical handover, but the success of a programme depends on much more than documentation. In your experience, what needs to be in place for process knowledge and technical understanding to transfer effectively between teams?
Technology transfer cannot simply be a transfer of documents. You can transfer a protocol or a manufacturing process on paper, but you cannot transfer scientific judgement that way.
The teams on both sides need to understand why a process was developed in a particular manner, what the critical parameters are, where the risks are and what has already failed. That requires direct interaction between scientists, not just project managers exchanging documents.
There also has to be common ownership. If one team thinks it is the innovator and the other thinks it is merely the execution arm, the model will always remain transactional. The best technology transfers happen when both teams feel responsible for the same product and the same patient outcome.
3. Biotech programmes can evolve rapidly as scientific and clinical data emerge. How should development and manufacturing infrastructure be designed to accommodate this uncertainty while maintaining operational and financial discipline?
Biotech development is inherently uncertain. A programme can change substantially after a regulatory interaction, a clinical readout or even a new scientific observation. Building infrastructure around fixed assumptions too early can therefore become very expensive.
I prefer a modular approach. Keep the core scientific and programme leadership internally, but build access to specialised capabilities through a combination of internal teams and external partners. Manufacturing capacity, analytical capabilities and clinical infrastructure should be scalable as the programme matures.
Capital discipline is particularly important in biotech because every dollar spent on unnecessary infrastructure is a dollar that cannot be spent on generating the next piece of clinical evidence. The objective should therefore be to build enough capability to control quality and science, without building capacity well ahead of the evidence.
4. As development and manufacturing activities become more geographically distributed, maintaining consistent quality becomes more complex. What should organisations focus on to ensure GMP, data integrity and validation remain robust across US and India operations?
Quality cannot be different depending on geography. There should not be an Indian quality standard and an American quality standard. There should be one global standard.
That starts with common systems, clear accountability and strong documentation. But equally important is culture. People need to understand that quality is not something inspected at the end of a process. It has to be built into development from the beginning.
For a distributed organisation, senior technical and quality leadership also needs visibility across locations. Data integrity, validation, change control and deviation management should follow the same principles irrespective of where the work is being performed.
Geography can change. The standard cannot.
5. Cost is only one part of the equation when evaluating a cross border operating model. Which operational and technical measures give a more meaningful picture of the value being created?
The most useful measure is not simply how much cheaper an activity is in India. The better question is what scientific and development output you are generating for every dollar of capital.
I would look at development timelines, quality of data, regulatory acceptability, number of meaningful experiments completed, speed of problem solving and ultimately how quickly a programme moves from an idea towards clinical proof of concept.
For an innovation company, capital efficiency should mean more science and better decisions per dollar, not simply lower salaries or lower manufacturing costs. That distinction is very important.
6. India brings considerable experience in pharmaceutical manufacturing, while US biotech companies often operate with a different pace of innovation and decision making. What needs to happen at the interface between the two for these strengths to work together effectively?
Both sides have something to learn from each other.
The US biotech ecosystem is very good at moving quickly around an emerging scientific hypothesis. Decisions can be made with incomplete information because waiting for perfect information can itself destroy value. India, on the other hand, has enormous experience in process development, manufacturing, scale and disciplined execution.
The opportunity is to combine the speed and risk taking of biotech with the execution depth of Indian pharma. For that to happen, decision making cannot become trapped in layers of hierarchy. Scientists and programme leaders across both countries need direct access to each other, clear authority and a common understanding of priorities.
If we can achieve that, India does not remain at the downstream end of innovation. It becomes part of the innovation process itself.
7. For organisations evaluating an India-US operating relationship, what practical signals should they look for in the early stages to determine whether the relationship is developing into a deeper strategic model rather than remaining transactional?
The simplest test is to see where the difficult questions are being discussed.
If the India team is only receiving specifications and executing tasks, it is still a transactional relationship. When scientists in India are participating in programme strategy, challenging assumptions, solving development problems and contributing to decisions, the relationship has become much more strategic.
Another important signal is whether information moves freely in both directions. Strong partnerships do not hide failures. They discuss them early because a failed experiment can be as valuable as a successful one if it leads to the right decision.
Over time, I believe the most successful model will be one where it becomes increasingly difficult to describe which part of the innovation happened in India and which part happened in the US. It will simply be one integrated global development organisation.
That, to me, is the real promise of the US India Innovation Corridor.
About the Guest | Venkat Nelabhotla
Venkat Nelabhotla is Co-Founder, President & CEO of Vyome Holdings, Inc., a Nasdaq-listed company with over 30 years of experience across the pharmaceutical, biotech, and consumer products industries. His expertise spans growth strategy, operations, drug development, scaling, fundraising, M&A, and international expansion across the USA, India, and global markets.
As Co-Founder & CEO of Vyome Holdings, he has been involved in developing novel drugs for immuno-inflammatory indications, while driving growth through pipeline development and fundraising.
His experience across the US and India gives him a practical perspective on how scientific
capabilities, development expertise, and execution can be integrated across the two
ecosystems.
Disclaimer
The views and opinions expressed in this editorial are those of the interviewee and are based on his professional perspective and experience. They do not necessarily reflect the official views, policies or positions of Hello Pharma, its management or its affiliates.
Hello Pharma does not endorse or take responsibility for any specific technical, commercial, scientific or regulatory interpretations presented in this article. Readers are encouraged to independently evaluate the information shared and rely on their own experience, expertise and professional judgement before making decisions related to biotech development, manufacturing, technology transfer, operating models or regulatory strategy.
