As India moves to expand to 1,000 accredited clinical trial sites across the country, it signals a clear ambition to position itself as a global hub for drug development. Yet, as breakthroughs in biologics, biosimilars, CAR-T therapies, vaccines and precision medicine reshape the global landscape, the challenge is not just about scale, it’s also about building a clinical trial ecosystem that is credible, reliable and future-ready.
Globally, drug development is becoming more complex, targeted and data-driven. Advanced therapies such as immunotherapies and cell and gene therapies require highly specialised trial designs, sophisticated infrastructure and deeply trained investigators. At the same time, even small molecule innovations continue to demand rigorous, multi-centric clinical trials to ensure safety, efficacy and regulatory compliance.
The opportunity: India’s progress in global clinical research
India’s large and diverse patient pool, cost advantages and growing scientific capabilities position it uniquely in the evolving global clinical trials landscape. With over 800 medical colleges and an expanding network of corporate hospitals, the country has a strong foundation to significantly scale and decentralise clinical trials beyond metropolitan centres. Recent policy pushes to expand accredited trial sites, faster regulatory approvals, and increased participation from private healthcare providers are further accelerating this shift.
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Additionally, increasing regulatory alignment, expanding diagnostic infrastructure, and rising industry-academia collaboration are strengthening India’s credibility as a preferred destination for global trials.
India's increasing leadership in global studies, better digital adoption for trial management, and greater emphasis on patient-focused trial designs are all driving this progress forward. As drug development becomes more complex and data-driven, India can not only support global innovation but also emerge as a leader in delivering high-quality, efficient and cost-effective clinical research.
Bridging systemic gaps: Talent, infrastructure and governance
Despite immense potential, clinical trials in India are concentrated in a few metropolitan centres such as Delhi, Mumbai, Kolkata, Hyderabad and Pune. This concentration limits both patient access and the scalability of trials. With over 800 medical colleges and a vast network of corporate hospitals, India has an untapped opportunity to decentralise and expand its clinical trial footprint.
One of the most pressing gaps is the shortage of competent and well-trained clinical investigators. Conducting clinical trials requires deep familiarity with regulatory frameworks, including Indian Good Clinical Practice (GCP) guidelines as well as global standards. Investigators must be equipped to handle complex protocols, ensure patient safety, maintain data integrity and meet stringent ethical requirements.
Infrastructure is another critical challenge. While India has made progress, there remains a shortage of sites equipped to conduct early-phase trials, particularly Phase I studies, as well as trials in specialised areas like oncology and biologics. High-quality clinical trial sites must be supported by reliable diagnostic and laboratory infrastructure, including NABL-accredited facilities, to ensure that data generated in India is globally acceptable.
Regulatory awareness and adaptability are also gaining importance. With a dynamic regulatory landscape, ongoing efforts toward continuous engagement, training and knowledge sharing are helping institutions stay aligned with evolving global expectations.
The way forward: From capacity building to global credibility
Ethics governance must remain at the core of India’s clinical trial expansion. As the ecosystem scales, the development of well-trained, independent and competent ethics committees becomes critical. These bodies are central to safeguarding patient rights, ensuring informed consent and upholding ethical standards. Scaling their capacity through structured training, standardisation, and accreditation will be essential to sustaining trust in the system.
At the same time, India must strengthen its focus on data integrity and global acceptability. Building awareness around patient privacy, confidentiality and robust documentation practices is no longer optional.
Adherence to globally aligned GxP frameworks, including Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP), will be key to ensuring that data generated in India is credible, reproducible and accepted across regulatory jurisdictions.
Addressing these challenges requires a coordinated, multi-stakeholder approach. Capacity building must move beyond intent to execution through structured training programmes, hands-on workshops and continuous regulatory education. Collaboration between government regulators, academic institutions and the pharmaceutical industry will be critical in creating a sustainable talent and infrastructure pipeline.
India has all the foundational strengths to emerge as a global clinical trial hub. With strategic intent, policy support and sustained investment, the nation can accelerate drug development while positioning itself as a trusted and indispensable partner in the global healthcare innovation ecosystem. It can move from being a cost-efficient destination to a capability-driven global leader in clinical research.
Dr Yogendra Kumar Gupta is the president of AIIMS, Jammu.
The opinions expressed in this article are those of the author and do not purport to reflect the opinions or views of THE WEEK.
