The global clinical trials market is witnessing rapid growth, driven by increasing R&D investments, biologics, and precision medicine, with the Asia-Pacific region emerging as the fastest-growing destination. India is strengthening its position as a preferred clinical research hub, backed by a large and diverse patient pool, cost advantages, regulatory reforms, and government initiatives.

Against this backdrop, industry experts came together to discuss India's potential to become a global clinical trials hub organized by Indian Pharma Post on June 19, 2026 

At the E-Conference titled, ‘The Future of Clinical Research in India: Can India Become a Global Trial Hub?’, the leading experts examined current market dynamics, benchmarking against global trends, and identifying actionable strategies to enhance competitiveness and accelerate growth. 

Welcoming the panelists and delegates, Pravin Prashant, Executive Editor, Indian Pharma Post provided a peek into the market scenario.

“Despite the potential it holds, the CRO industry in India is merely an estimated $1.4 billion industry as compared to the biotechnology and pharmaceutical sectors that are separately aiming to reach $300 billion target by 2030. It is surprising to see that despite a huge population, we hold merely 2-3 percent of global share,” said Prashant. 

The session was moderated by Rahul Koul, Editor, Indian Pharma Post who set the tone of the discussion.

”India stands at a pivotal moment in its clinical research journey. While regulatory reforms have created a strong foundation, becoming a global clinical trials hub will require equal focus on infrastructure, digital innovation, skilled talent, and public trust. This discussion aims to identify the practical steps needed to unlock India's full potential in global clinical research, outlined Koul.

Expressing optimism about the Government of India's initiative to establish 1,000 accredited clinical trial sites, Prof. Y. K. Gupta, President, AIIMS, Kalyani called it one of the most significant steps towards strengthening clinical trial capacity in the country. 

Prof Gupta opined: “One of the biggest advantages of this initiative is that it will improve the diversity of clinical trial participation. Today, nearly 80% of clinical trial sites are concentrated in just 2–3 metropolitan cities. By expanding accredited sites across the country, we can improve patient diversity, enhance the global visibility of India's clinical research capabilities, and potentially increase India's share of global clinical trials from the current 2% to 5–10% over the next four years. This will also accelerate new drug development as India aims to build a strong pipeline of biologics.”

“The challenge, however, lies in execution. Developing 1,000 clinical trial sites requires adequately trained investigators, robust data management systems, skilled biostatisticians, data analysis centres, and proper archival infrastructure. Rather than expecting every site to conduct all types of studies, we should categorize them based on their capabilities—advanced centres for complex trials such as biologics, oncology and cardiology, dedicated sites for Phase III and IV studies, and a broader network for Phase IV and academic research,”  added Prof. Gupta.

On the question of India’s far lesser contribution to global clinical trials, Dr. Mrinal Kammili, Head of Translational and Clinical Research, Syngene International listed several long-standing barriers that have limited the growth. 

Dr Kamini elaborated: “One of the biggest challenges has been the lack of adequate clinical trial infrastructure, particularly sites capable of conducting global early-phase and Phase I studies. Global sponsors typically seek end-to-end development capabilities, and this has historically been a gap. Another important factor has been concerns around the quality and perception of data generated in India, along with intellectual property protection, which made many global companies cautious about bringing first-in-class or early-stage assets into the country. Patient awareness has also remained limited. Despite our vast patient population, we have not had enough patient advocacy and community outreach programmes to improve participation in clinical research.”

"However, I believe the situation is changing rapidly. The implementation of the Digital Personal Data Protection (DPDP) framework has also helped address concerns around data security and intellectual property, We are also witnessing greater adoption of AI-enabled technologies, electronic data capture platforms, and digital systems that improve data integrity and operational efficiency. At the regulatory level, recent amendments to the New Drugs and Clinical Trials (NDCT) Rules have introduced more flexible approval pathways for certain global studies, making India a more attractive destination for international sponsors.While there is still work to be done, the momentum is clearly positiv,” eadded Dr. Kammili. 

Mr. Binoy Gardi, Managing Director and Group CEO, Veeda Lifesciences feels that India has come a long way in terms of clinical trial regulations.  “I have had the opportunity to witness the evolution of India's clinical trial regulatory ecosystem—from the optimism of the early 2000s, through the challenges of 2012–13, to the much stronger framework we have today. While perceptions from that difficult period still linger in some quarters, I believe India's regulatory environment has become far more robust.”

“The introduction of the New Drugs and Clinical Trials (NDCT) Rules, 2019, has been a landmark reform that has brought India much closer to global regulatory standards. Although our approval timelines are still longer than those in the US, where reviews are completed in around 30 days, or Europe, where they typically take about 60 days, we have made significant progress compared to where we were a decade ago. The government deserves recognition for these reforms, which have created a much stronger foundation for clinical research,” said Mr. Gardi.

"That said, regulation alone cannot make India a global clinical trial hub. Several other factors contribute to competitiveness, and one area that still requires attention is the consistency and predictability of regulatory timelines. While the framework exists, sponsors continue to seek greater confidence that timelines will be adhered to consistently. This is one of the most common questions we receive from global pharmaceutical companies evaluating India as a clinical research destination. With continued improvements in regulatory consistency and greater emphasis on early-phase clinical research, I believe the country is well positioned to emerge as a preferred global destination for clinical trials,” he added.

On the question of learnings from countries such as Australia, South Korea, Singapore, and China, Dr. Sanish Davis, Exec. Committee Member, Indian Society for Clinical Research (ISCR) outlined a few important lessons. “One common factor across these countries is their strong focus on early clinical development. Australia, for example, combines attractive financial incentives for clinical research with highly predictable regulatory timelines and world-class institutions that global sponsors trust. Similarly, South Korea has built an integrated ecosystem through strong government support, coordinated infrastructure, and leading medical centres that consistently participate in global studies.”

“The key lesson for India is that regulatory reforms alone are not enough. While predictable approval timelines are important, they represent only one part of the overall clinical research ecosystem. We also need institutions that can execute global clinical trials with the same level of commitment and competitiveness as their own academic research. Building centres of excellence with experienced investigators, robust infrastructure, and international-quality execution is equally critical. India is certainly moving in the right direction, but incremental progress will not be enough. We need to accelerate investments in infrastructure, investigator training, institutional capabilities, and ecosystem development. With a coordinated and faster approach, I believe India has the potential to significantly increase its share of global clinical trials and emerge as a leading destination for clinical research,” added Dr. Davis. 

Sharing his perspective on collaborative R&D, Dr. Sanjay Sarin, Continental Lead Asia and South Asia Director, Drugs for Neglected Diseases initiative (DNDi) mentioned that while the phrase "bench to bedside" sounds straightforward, the journey from scientific discovery to patient care is rarely linear and almost never succeeds in isolation. 

“This is especially true in neglected diseases, where traditional pharmaceutical R&D models driven by commercial returns have often failed to translate promising discoveries into treatments for underserved populations. The scientific knowledge exists, the disease burden is well understood, but the gap between discovery and patient access remains significant. At DNDi, we have tried to bridge this gap through an alternative R&D model that prioritizes patient needs over commercial returns. We bring together academia, public research institutions, industry, regulators, clinicians, and, importantly, patients into a coordinated collaborative framework. This approach has enabled us to advance treatments that might otherwise have remained inaccessible," said Dr Sarin.

“In the Indian context, this collaborative model is particularly relevant. India has world-class research institutions, a vibrant pharmaceutical industry, and strong clinical capabilities. However, collaboration among these stakeholders is often fragmented and limited to individual projects. What India needs is a more structured institutional framework that promotes long-term public-private partnerships, shared biobanks, open-access data platforms, and joint investigator training programmes. The government's efforts to expand clinical trial capacity are a welcome step in this direction. As translational research gains greater scientific, regulatory, and reputational importance, India has a significant opportunity to build the collaborative infrastructure needed to accelerate innovation and ensure that research outcomes translate into accessible healthcare solutions rather than remaining confined to laboratories,” Dr Sarin added further.

Dr. Renu Razdan, Senior Vice President, JSS Medical Research India believes public trust and ethical conduct are inseparable when it comes to the success of clinical research. 

Dr Razdan opined: “India’s clinical research sector has experienced difficult phases in the past because concerns raised by the public, whether fully justified or not, were not addressed effectively. If we want to build a globally competitive clinical research ecosystem, we must proactively strengthen both public awareness and transparency. The first priority should be educating people about what clinical trials are and why they are essential for developing innovative medicines as well as generic therapies. Even among educated individuals, there is considerable confusion about whether participation in a clinical trial is entirely voluntary and what rights participants have. This highlights the urgent need for coordinated awareness campaigns led by both the government and industry.”

“Transparency is equally important. We already have the Clinical Trials Registry–India (CTRI), which is a strong platform. Going forward, I believe regulatory approvals should be seamlessly linked to the registry so that the public can easily verify approved studies. Clinical trial results should also be published within defined timelines, regardless of whether the outcomes are positive or negative. Such measures will significantly improve public confidence in the clinical research process. Another critical area is informed consent. While the regulatory framework is robust, the consent process must be presented in simple, easily understandable language. Finally, all stakeholders—including regulators, hospitals, investigators, and industry—must treat adverse events and serious adverse events with the highest level of seriousness. A transparent, ethical, and patient-centric approach will be fundamental to rebuilding public confidence and encouraging greater participation in clinical research across India,” added Dr Razdan.

Dr. Kavita Kachroo, Chief Operating Officer, Kalam Institute of Health Technology  shared her perspective on what differentiates KIHT from other CROs conducting clinical trials is that it is an evidence generation and health innovation institution embedded within one of the world's largest medical device ecosystems. 

“From ideation to commercialization, we provide an end-to-end ecosystem that includes incubators, testing facilities, regulatory support, large-animal preclinical testing, clinical validation, and now an approved clinical trial unit. This enables us to bridge the gap between industry and academia while accelerating innovation translation. As a technology policy institute, KIHT goes beyond conducting trials. As a DHR Resource Hub for Health Technology Assessment and a WHO Collaborating Centre for Health Innovation, we support innovators through evidence generation, prototype development, preclinical studies, regulatory pathways, clinical validation, commercialization, mass manufacturing, and ultimately health system adoption,” said Dr Kachroo.

"Our strength lies in bringing together every component of the innovation continuum under one roof. We combine clinical research, health technology assessment, policy translation, innovation support, and capacity building to generate scientifically rigorous and clinically meaningful evidence that supports healthcare decision-making and faster adoption of innovations.” As a WHO Collaborating Centre, we also help Indian innovations scale globally by connecting them with international healthcare ecosystems and global supply chains,” added Dr. Kachroo.

Dr. Pranjal P. Bordoloi, Senior Vice President - Late Phase Operations, Lambda Therapeutic Research Limited is super confident about India emerging as a global clinical trial hub.

Dr Bordoloi elaborated: “This is not just a hopeful statement but we have already proven our capabilities through healthy volunteer bioavailability and bioequivalence (BA/BE) studies. Over the past three decades, India has built world-class expertise in this segment and today contributes an estimated 20–30% of global healthy volunteer studies.  The challenge now is to translate this proven success into late-phase global clinical trials. The first priority is regulatory alignment. Approvals must be time-bound, consistent and harmonized with global standards. Equally important is building trial-ready infrastructure, not just increasing the number of clinical trial sites, but ensuring they can recruit predictably, deliver high-quality data and successfully meet global audits and inspections. Research must become a dedicated function within hospitals rather than an additional responsibility."

"Digitalization is where India has the opportunity to leapfrog globally. Just as India emerged as a global IT leader and built world-class digital public infrastructure, we can apply the same strengths in clinical research. Integrating hospital systems, clinical trial platforms and regulatory systems will enable real-time data, faster decision-making, better analytics and more patient-centric decentralized trials, while maintaining strong data privacy and security.” If we can standardize infrastructure, strengthen talent and fully leverage digitalization, India can deliver global-quality clinical trials with unmatched speed, quality and trust. We transformed the world through IT services; our next opportunity is to generate evidence for the world through clinical research,” added Dr. Bordoloi. 

Emphasizing the need to strengthen research, infrastructure and digital interface, Dr. Avi Kulkarni, CEO & Head of CRO, InoRx Limited (part of SRM Group) calls for private financing to boost the industry’s chances to emerge as a global hub. 

Dr Kulkarni explains his point: “The investments cannot come from government alone. While policy support is essential, private industry must play an equally significant role in developing research infrastructure, technology platforms, and clinical trial capabilities. If India can combine regulatory progress with sustained investments in infrastructure, digitalization, talent, and public-private partnerships, it has every opportunity to emerge as one of the world's leading destinations for global clinical research. Patient recruitment remains one of India's greatest strengths because of our large and diverse population, but challenges such as delayed site activation, regulatory bottlenecks, patient retention, and fragmented medical records must be addressed.  Equally important is investigator training.”

 ”Research infrastructure, patient recruitment, and investigator training are not just important but the three defining pillars that will determine whether India's current clinical research momentum becomes permanent. We need world-class, digitally enabled hospitals and research centres capable of consistently generating data that meets global regulatory expectations. Investments must focus on electronic health records, globally accredited laboratories, advanced imaging facilities, integrated clinical trial platforms, AI-enabled technologies, robust cybersecurity, and data privacy compliance. India has the talent and technology ecosystem to build globally competitive digital infrastructure for clinical research,” added Dr. Kulkarni.

On the question of whether India is prepared for conducting trials for next generation therapies, Dr. Somesh Bolegave, Head - Biometrics, Regulatory and Medical Services, SIRO Clintech while expressing his confidence stated, “India’s clinical research ecosystem is increasingly prepared to support next-generation therapies such as cell and gene therapies, mRNA-based medicines, precision medicine, and digital therapeutics. From an infrastructure perspective, we are largely at par with global standards. We have the necessary site infrastructure, transportation networks, storage facilities, digital capabilities, and regulatory mechanisms to execute these complex clinical trials. In fact, several gene therapy, stem cell therapy, and personalized medicine trials are already underway in India.”

“The real challenge today is not infrastructure but perception. While global sponsors recognize India's strengths in areas such as data management, biostatistics, and backend clinical research operations, they continue to question whether our operational execution and standards of care consistently match global expectations. The encouraging part is that India possesses a significant technology advantage. With strong digital infrastructure, widespread connectivity, AI capabilities, and an expanding health-tech startup ecosystem, we have all the ingredients needed to support advanced clinical research,” added Dr. Bolegave. 

“India has tremendous potential to emerge as a global leader in clinical research, but the foundation of that ambition must be trust,” stated Dr. Partha Mitra, Medical Research Scientist, Flinders Cancer Innovation Centre, Govt. Of South Australia

“One of the biggest lessons India can learn from Australia is the importance of building a dedicated clinical trial governance framework. Clinical research should not be treated as an extension of broader drug regulation or scientific research. It requires a specialized regulatory system with clearly defined rules, operational standards, and accountability mechanisms that are followed uniformly across every trial site. Australia has built this through the Therapeutic Goods Administration (TGA), which provides comprehensive guidance for conducting clinical trials. Every sponsor, investigator, and institution is expected to comply with these standards without compromise. India does not need to replicate the Australian model, but it can certainly adapt international best practices—including European frameworks—to suit Indian demographics, healthcare systems, and cultural realities,” said Dr. Mitra.

“Patient education is another area where India can draw valuable lessons. In Australia, patients are educated about the purpose, benefits, risks, and rights associated with clinical trials before they decide to participate. Many patients are unaware that clinical trials can provide access to cutting-edge therapies when standard treatments are no longer effective. Building structured patient awareness and education into the clinical research ecosystem will improve recruitment while strengthening public confidence in research,” added Dr. Mitra.

“Ultimately, India's success as a global clinical trial destination will depend on creating a trusted ecosystem built on strong governance, standardized regulations, continuous quality monitoring, world-class hospital infrastructure, and informed patient participation. These are the pillars that will inspire confidence among global sponsors and position India as a preferred destination for multinational clinical research,” Dr Mitra concluded.

As a part of its industry connect programme, the Indian Pharma Post has launched a series of E-Conferences on various important topics focused on pharma, biopharma and healthcare. Stay tuned for our upcoming E-Conefrence.