India is well on its path to strongly push back the perception battle of quality
As we mark International Clinical Trial Day today, Dr Seema Pai, President, ISCR explains to Viveka Roychowdhury why it is important to not just scale the clinical research ecosystem, but to ensure it is built on a strong foundation of trust, quality, and patient-centricity. The good news is that with the apex regulatory body and ICMR supporting innovation and use of technology, India is well on its path to strongly push back the perception battle of quality
Regulators like the US FDA have flagged concerns around data integrity, data falsification, inadequate documentation, etc., with some CROs in India, which resulted in sponsors having to repeat studies. What can be done to re-emphasise the role of ethics, patient safety, and transparency in rebuilding global confidence in India’s clinical research ecosystem?
The US FDA has not flagged any concerns in global clinical trials from India and no sponsor has had to repeat studies due to Indian data. The concerns about data integrity and documentation are for some rare instances of BA/BE studies and must be addressed through robust systems, greater transparency that do not tarnish the whole clinical research fraternity and clearly calls out these organisations.
Most CROs and pharma companies operating out of India have strong robust quality integrated practices and follow global norms with data accepted by all global regulatory agencies especially post the strengthening of the regulatory framework in India in 2019. The government and regulator have been working closely with the industry, academia, patient safety groups and have been very instrumental in strengthening the scientific integrity of the work done in India and building global confidence.
ISCR remains committed to collaborating with industry stakeholders to cultivate an ethical, patient-centered and globally competitive clinical research environment in India by training, advocating, and enhancing capabilities. The training and quality council within ISCR along with the collaboration with several agencies and institutions have continually contributed to enhancing the quality of trials done in India.
What are the key gaps that still need to be addressed in terms of infrastructure, speed, regulatory clarity, and trust-building, without which India cannot become a preferred global destination for clinical trials and drug development?
India possesses several foundational strengths for a thriving biopharma sector, including a diverse patient pool, a strong scientific talent base, and a rapid increase in research capabilities. However, to become a preferred global destination, key gaps across infrastructure, speed, regulatory clarity and trust must be addressed.
From an infrastructure standpoint, initiatives such as the Biopharma SHAKTI programme to establish 1,000+ clinical trial sites are important first steps. However, sustained investment in trained clinical research professionals, digital infrastructure and site-level governance is essential to ensure consistent quality across locations.
On speed and regulatory clarity, while the NDCT Rules of 2019 have significantly improved approval timelines and access to research in India, greater consistency, predictability and standardisation across trial sites and Ethics Committees remain critical. Ease of early phase approvals and regulatory pathways to support early clinical development and manufacturing will further build confidence.
Finally, trust-building will depend on India’s ability to demonstrate consistently performing in terms of the standardised start up timelines, continue to have minimal to no quality issues in trials conducted and continue to improve the access to patients with data quality and completeness.
Addressing these holistically will be key to positioning India as a credible, competitive and preferred hub for global clinical research and drug development.
How can digital innovation and technology help reduce human error/deliberate falsification to improve trial efficiency, monitoring, and data quality?
Digital Innovation and Technology is not a substitute for ethics and moral conduct of clinical trials, but it can significantly reduce opportunities for error and deliberate falsification by improving transparency and traceability across the clinical research process.
Electronic Data Capture (EDC) systems with validated audit trails help ensure data integrity by creating tamper-evident records. Digital health platforms also support decentralised clinical trials, enhancing operational efficiency while expanding patient access and participation across geographies. Oversight by Ethics Committees at a hospital level and the regulatory agency at a central level with efficient monitoring from the sponsor help in building an overall quality management system for a study.
In-built robust data management systems are already being run out of India for most pharma companies for the entire globe out of the GCC hubs which helps India to effectively prove that we can integrate operations and technology to ensure quality.
With the apex regulatory body and ICMR supporting innovation and use of technology India is well on its path to strongly push back the perception battle of quality.
What is the roadmap to build inspection-ready excellence at the site level and enhance India’s competitiveness globally?
Being inspection-ready is not a periodic activity, but a continuous state embedded in the day-to-day functioning of every high-quality clinical trial site. A strong roadmap begins with an honest evaluation against global standards such as ICH-GCP E6(R3), followed by the implementation of standardised processes, robust documentation practices and site-level SOPs to ensure consistency and compliance.
Building capability is equally critical. This includes ongoing training for site staff, regular internal audits and mock inspections and the adoption of structured site accreditation frameworks to institutionalise quality. Initiatives such as the ICMR’s INTENT network, which is strengthening capabilities across select sites. The building of the CTN network by BIRAC and the accreditation of ethics committees and cross
Pollination of knowledge across different bodies provides a strong foundation for scaling high-quality, regulatory compliant Phase II and Phase III trials, offering a solid base for further development. India would soon also start to focus on the mentoring of its Principal Investigators which is already an imperative for ISCR via its Academic consortium where over 50+ institutions are working hand in hand with ISCR. Advocacy and awareness offering career pathways and jobs in clinical research to support a sustainable professional career, particularly in academic and public health institutions is also part of ISCR initiatives.
India’s clinical trial ecosystem includes industry, regulators, hospitals, and policymakers. How can these different stakeholders collaborate to scale the ecosystem, and what is ISCR’s role in this process?
Progress cannot be driven by any one stakeholder alone. The industry cannot leverage India’s research infrastructure without also contributing to its development and long-term sustainability. At the same time, regulators play a critical role in providing clear, consistent, and globally aligned frameworks that enable efficiency while ensuring patient safety and data integrity.
A consistent and globally aligned clinical research framework can only emerge through sustained collaboration. Hospital administrators play a critical role in this ecosystem by allocating dedicated research funding and providing protected time for investigators and site staff. At the same time, government-led initiatives such as the Biopharma SHAKTI program, which has committed INR 10,000 crore to strengthen institutions like CDSCO, NIPER, and the accreditation of over 1,000 clinical trial sites—mark a significant shift in enabling infrastructure and capacity. Such policy support must be effectively implemented and sustained to drive meaningful impact.
ISCR aims to serve as a knowledge partner and provide thought leadership as the unifying platform that brings all stakeholders in clinical research together, builds trust across the ecosystem, and encourages participation in research-driven initiatives. Through advocacy, capability building, and collaboration, ISCR seeks to strengthen India’s clinical research landscape and position it as a globally credible and competitive destination.
As we mark International Clinical Trial Day, this collective commitment becomes even more important not just to scale the ecosystem, but to ensure it is built on a strong foundation of trust, quality, and patient-centricity.