India has steadily strengthened its position in the global pharmaceutical landscape, with established capabilities across research, development and manufacturing. This progress has encouraged multinational companies to expand their R&D presence in the country, spanning clinical trials, product development and regulatory work.

Over the past decade, India has also seen growing momentum in biopharma innovation, driven by a new generation of agile biotech companies, stronger government support for deep-tech startups and the growth of contract research, development and manufacturing services. Together, these shifts are strengthening India’s position in innovation-led drug development.

A Shift in Clinical Trial Expectations

The need for consistency is becoming more urgent as clinical development evolves. Clinical trials today are more complex than before. Adaptive protocols, biomarker-driven studies and smaller, targeted patient cohorts are becoming more common, particularly in oncology and rare diseases.

India has seen consistent growth in clinical trial activity, with over 94,000 trials registered on the Clinical Trials Registry of India (CTRI) since 2007. But the next phase of growth will depend less on numbers and more on how well this complexity is managed.

Consistency across trial sites remains a key challenge. Differences in infrastructure, processes and training can affect both timelines and data quality. Addressing this will be essential as India takes on a larger role in global studies.

Preparing for Advanced Therapies

The shift toward advanced therapeutics further raises the bar. Cell and gene therapies, immunotherapies, and targeted biologics require a higher level of clinical readiness, including specialised storage and handling, closer patient monitoring, and strict adherence to highly specific protocols.

For India, this means strengthening site readiness and ensuring more standardised infrastructure. The ability to run complex trials reliably will increasingly define competitiveness.

Policy as a Catalyst

Recent policy signals point in the right direction. The Union Budget 2026, through initiatives such as BioPharma SHAKTI, aims to strengthen capabilities in biologics and emerging therapies while supporting the broader research ecosystem.

The plan to establish over 1,000 accredited clinical trial sites is a particularly important step. Beyond expanding capacity, it can help bring greater consistency, improve oversight and build confidence in trial outcomes. Expanding beyond major cities may also improve access and participation in clinical studies.

Building Trust in Global Research

As clinical programmes become more global, consistency across geographies is critical. India’s ability to integrate more deeply into global trial networks will depend on reducing variability and aligning with international expectations on quality and compliance.

Efforts to strengthen training and build clinical research capabilities are already underway, with greater emphasis on practical and site-based learning. At the same time, predictable regulatory processes will remain an important factor for global sponsors.

Global Capability Centers (GCCs) are also playing a supporting role by strengthening data management and operational coordination, helping India connect more effectively with global research programmes.

Also read: Moving from Hardware-Centric Systems to Software-as-a-Medical-Device (SaMD)

The Way Forward

India’s opportunity lies in being seen not just as a large clinical trial market, but as a dependable one. This will require continued focus on consistency, capability building and regulatory clarity.

If these elements come together, India can play a larger and more meaningful role in advancing clinical development and improving access to next-generation therapies.

Views expressed by: Dr. Priya Kapoor G. Hingorani, Managing Director, Miltenyi Biotec India and VP APAC 

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Disclaimer: The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or views of any organisation. The content is intended for informational and educational purposes only and should not be construed as medical advice.

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