India is on the path to becoming a global powerhouse in clinical research, driven by transformative advancements across the healthcare landscape. With a richly diverse population, a highly skilled workforce and a strong regulatory framework, the country is steadily positioning itself as a preferred destination for advanced clinical trials.
Some of the key drivers of India’s growth journey are innovation and digital transformation, unwavering commitment to quality and ethics and how a progressive yet meticulous regulatory environment is accelerating trial timelines and enhancing operational efficiency.
Breaking new ground in clinical trials
The Indian clinical research industry is experiencing unprecedented growth. The high burden of both infectious and non-communicable diseases highlights the need for pioneering clinical studies in the country. With access to one of the world’s largest patient populations, India presents a unique blend of challenges and opportunities for healthcare innovation.
For long, India was known for late-phase trials, but it is slowly being recognised for its phase-1 and early-phase clinical trials. The Indian Council of Medical Research has grown to a threshold of facilitating partnerships for new and innovative therapies like CAR-T cell treatment, vaccines and gene & cell therapies.
Not only does this move India up the ladder in its research capabilities, but it also makes it stand amongst the world’s leading medical innovators. Recent advancements in mRNA-based treatments and the worldwide priority, i.e., antimicrobial resistance (AMR), further underline this progress.
Relentless pursuit of ethics and quality
India’s regulatory frameworks ensure strict adherence to international safety standards like Good Clinical Practice (GCP) and keep a close check on oversight of the trial conduct through Institutional Ethics Committees (IECs), sponsors and digital oversight. In the same vein, safeguards like an audio-visual informed consent for vulnerable participants for NCE (New Chemical Entity) / NME (New Molecular Entity) trials, compensation and medical management guidelines ensure participants' protection.
Similarly, reforms like the 2019 Clinical Trial Rules and a strict licensing process regulated by the Central Drugs Standard Control Organization ensure transparency with a streamlining of the process.
Furthermore, with the help of a robust network of universities and healthcare aligned with specialised research facilities, India has improved the clinical research trial sites both in terms of capacity and steady improvement in quality. There has been a significant rise in drug discovery, startups, and the rise of Global Capability Centres (GCCs), which are now able to support functions in critical areas like clinical data management, clinical development oversight, and biostatistics, to name a few.
Digital transformation in action
India is at the tipping point of digital transformation, with artificial intelligence and machine learning used to improve the patient recruitment process. A better analysis of electronic health records (EHRs) reduces the recruitment time by almost half, and using AI in data collection, protocol optimisation, and result predictions improves scientific rigour, trial efficiency, and data quality.
To add to this, increased adoption of decentralised clinical trials (DCTs) widens the scope of patient access beyond the metro cities and also allows the pharmaceutical companies to reach the rural areas with access to the elderly facing mobility challenges, children, and sometimes even pregnant women. With the emergence of digital tools like e-consent, telehealth services, and wearable health technology, real-time monitoring and data transmission have enhanced patient care, creating vast databases for researchers.
Academic and career development
With the sector reflecting recognition as a frontier of healthcare innovation, clinical research is now considered a viable and impactful career option, leading to an increase in interest in academia, too. To empower and educate the next generation of clinical researchers with the skillset applicable to global clinical research, academic institutions across the country are growing their specialised programs in regulatory sciences, clinical research, and related subjects.
A more integrated academic ecosystem, along with hands-on research training, is building new partnerships between academia, the biopharmaceutical industry, and global corporate players.
Strengthening the clinical research ecosystem
The clinical research ecosystem is steadily strengthening with its fair share of hurdles. Trial sites are expanding, ethics committees are being trained, and treatment protocols, particularly in oncology, are increasingly aligned with global standards ensuring quality, safety, trust, and transparency.
Importantly, collaborations with ICMR, academic institutions and growing student interest are opening new career pathways for young scientists, building a talent pool that will carry Indian research forward with global relevance.
India’s moment
India’s road to becoming a global clinical research hub is not about numbers alone; it is about creating a socio-health system that blends science with scale, ethics with efficiency, and technology with trust.
With a plethora of stakeholders working closely and continued momentum, India would soon lead the development of medicines for a better tomorrow. The question is no longer whether India can do it. The real question is whether we can seize this moment and make clinical research one of the pillars of India’s global identity.
(Dr Seema Pai is the President at the Indian Society of Clinical Research.)
Edited by Jyoti Narayan
(Disclaimer: The views and opinions expressed in this article are those of the author and do not necessarily reflect the views of YourStory.)