What are your thoughts about the current trends and challenges facing the Indian clinical trials market? Where does India stand when we look at the global market?
India’s clinical trials ecosystem is at a defining stage. Over the last few years, we have seen a clear transition from being perceived primarily as a cost-efficient execution market to becoming a more capable, quality-driven, and innovation-oriented research environment. Regulatory predictability has improved post New Drugs and Clinical Trial Rules (NDCT), 2019 and more digital tools are being integrated into trial design, and India is increasingly participating in complex and India relevant studies, including biologics and advanced therapies. Globally, India has strong advantages in patient diversity, disease burden relevance, and operational scale. However, to fully establish itself as a leading research hub, we must ensure consistent quality across sites, faster ethics harmonisation, and deeper capabilities in advanced analytics and integrated evidence generation. The opportunity is clear, but disciplined execution will determine how far we progress.
How is ISCR strengthening the clinical trials and research sector in India? What are the major plans in store this year under your leadership?
ISCR continues to serve as a bridge between regulators, industry, academia, and site professionals. Our role is to facilitate dialogue, build capability, and promote global best practices in quality and ethics. We believe that sustainable growth in clinical research requires collaboration across stakeholders. This year, our focus is on strengthening structured training programmes, especially in clinical data management, clinical coordinator certification, etc. We are also deepening engagement with academic institutions to help build a future-ready workforce and supporting implementation of recent regulatory reforms at the ground level. Ensuring that policy intent translates into operational clarity remains a key priority.
What were the key objectives and takeaways of 19th ISCR Annual Conference 2026?
The 19th ISCR Annual Conference 2026 was organised around the theme of accelerating clinical research through digital innovation, global collaboration, and regulatory excellence. The objective was to align stakeholders on how India can move from volume-driven growth to value-driven research. Key discussions focused on bridging clinical and commercial development, decentralised trials, tracks focusing on medical writing, data management, early phase development, pharmacovigilance and, topics pertaining to strengthening accredited site networks, harmonising regulatory processes, and embedding patient-centric practices into everyday trial conduct. A major takeaway was that India now has strong policy momentum and infrastructure expansion; the next step is to deepen capabilities and ensure consistent execution across the ecosystem.
Union Budget 2026-27 has proposed creation of a network of over 1000 recognised Indian clinical trial sites. How does ISCR plan to leverage this new development?
The proposal to create a nationwide network of over 1000 recognised clinical trial sites is potentially transformative. It can reduce geographic concentration in metro cities, accelerate patient recruitment, and standardise quality benchmarks across regions. ISCR sees this as an opportunity to strengthen training frameworks, promote peer learning, and develop common quality standards across the network. If implemented effectively, this initiative can significantly enhance India’s attractiveness for multi-centric global trials and support participation in more complex and innovation-driven studies. The strengthening of regulatory reviews with scientific capability building is a fantastic welcome move where we will partner with all government and private stakeholders. The centricity around India specific diseases also helps in prioritisation and building capacities and capabilities in the right direction.
What are your expectations from the government to strengthen the clinical trials and research sector in India?
Continued regulatory predictability and alignment with global standards remain critical. We would like to see sustained efforts toward harmonised ethics review processes, support for investigator-initiated studies, and consistent implementation of digital health infrastructure. Equally important is policy stability and structured stakeholder consultation. Reforms are most effective when they are practical and implementation-friendly. Ongoing dialogue between regulators and industry will ensure that India remains competitive while maintaining strong ethical oversight.
How do you perceive the current career opportunities and workforce skill development gaps in clinical research?
Career opportunities in clinical research are expanding beyond traditional monitoring roles. There is growing demand in areas such as digital trial strategy, clinical data science, regulatory intelligence, pharmacovigilance, and real-world evidence generation. However, as trials become more data-intensive and innovation-driven, we need deeper expertise in advanced biostatistics, AI-enabled analytics, genomics-linked research, and integrated evidence strategy. Structured industry-aligned training, experiential learning at accredited sites, and stronger academia-industry collaboration will be essential to bridge these gaps and prepare the next generation of professionals.
How do we ensure that India emerges as a global hub for clinical trials and research in the coming years?
India’s emergence as a global hub will depend on three pillars: quality, speed, and trust. Quality must be consistent and supported by strong data governance. Speed must be predictable and aligned with global timelines. Trust must be built through ethical practices, patient protection, and transparent oversight. If we align regulatory reform, infrastructure expansion, digital integration, and talent development, India can firmly position itself as a science-driven and innovation-led clinical research leader by the end of this decade. The foundation is being laid; sustained collaboration and disciplined execution will determine how far we go.
Dr Manbeena Chawla
