Sidharrth Shankar
JSA Advocates & Solicitors, Gurugram
sidharrth@jsalaw.com

Eshika Phadke
JSA Advocates & Solicitors, Mumbai
eshika.phadke@jsalaw.com

Indian clinical trials ecosystem

India has long been seen as an attractive destination for clinical trials owing to its diverse patient pool, high burden of both communicable and non-communicable diseases, availability of skilled healthcare professionals who can serve as investigators, strong clinical infrastructure, and the comparatively low costs associated with running a clinical trial in India.

However, following a few high-profile incidents which sparked public outcry over multinational-sponsored trials, foreign sponsors began to perceive the Indian ecosystem as being laden with uncertainty and operational complexity. This, in turn, led to a temporary decline in the number of trials being conducted in India. Consequently, several life-saving drugs became available in India only several years after they were launched in other countries.

In response, the Indian government has introduced a slew of reforms aimed not only at improving the ease of conducting clinical trials but also aligning India’s ecosystem and framework with global best practices.

Key regulatory reforms

New Drugs and Clinical Trials Rules 2019

The most pivotal development has been the overhaul of the regulatory regime for clinical trials in India. The Ministry of Health and Family Welfare notified the New Drugs and Clinical Trials Rules 2019 (the ‘NDCT Rules’), replacing the relatively rudimentary regime for conducting clinical trials in human beings under the Drugs Rules 1945. The NDCT Rules introduced much-needed operational certainty by clearly setting out procedures for obtaining approvals, defining timelines, and allocating stakeholder responsibilities. The NDCT Rules also codified the sponsor’s obligations to provide post-trial access to subjects, extend medical management and pay compensation for trial-related injuries. In addition, the introduction of a formula for determining compensation due to a subject enabled sponsors to estimate the potential costs associated with a clinical trial upfront.

CRO registration and accountability

While the NDCT Rules brought about a degree of certainty, a key concern that remained unaddressed for foreign sponsors was the pivotal role of clinical research organisations (CROs). Because a foreign entity cannot directly hold permissions under the NDCT Rules, sponsors commonly engage an Indian CRO to act as the local sponsor. Despite their prominence in the clinical trials ecosystem however, CROs were not expressly recognised under the NDCT Rules when they were enacted. This created two practical challenges: first, foreign sponsors did not have unfettered control over the regulatory approvals held locally and were essentially tied to the CRO; and second, the CRO’s responsibilities were largely governed by private contracts rather than under the regulatory framework. To address this, the NDCT Rules were amended (effective April 2025) to distinguish CRO obligations from sponsor obligations, introduce a registration requirement for CROs, and make CROs directly accountable under the NDCT Rules.

Integration with global clinical trials

The NDCT Rules have laid down the groundwork for greater integration of the Indian arm into a larger global clinical trial. This is because a more stringent and globally harmonised framework boosts the integrity of the data generated in India, thereby increasing its acceptability among foreign regulators. India is also in the process of harmonising its Good Clinical Practice Guidelines (GCP) with ICH-GCP, which is expected to further enhance the global acceptability of Indian clinical trial data.

In line with these harmonisation efforts, the Indian regulator has been granted a discretionary power to waive local clinical trial requirements for certain drugs that have been approved in the United States, United Kingdom, European Union, Japan, Australia, and Canada, subject to specified conditions. Where available, these waivers can substantially reduce the burden of bringing such drugs to the Indian market.

Emerging trends shaping clinical trials in India

Adoption of artificial intelligence

Globally, artificial intelligence (AI) is influencing every stage of the clinical trial lifecycle. AI-enabled tools are increasingly being deployed for protocol design, preparation of regulatory documentation, patient recruitment, and data analysis, with the potential to reduce timelines and improve trial efficiency.

Taking cognisance of its rampant adoption in India as well, in 2023, the Indian Council of Medical Research issued the Ethical Guidelines for Application of Artificial Intelligence in Biomedical Research and Healthcare (the ‘ICMR AI Guidelines’), which emphasises principles such as safety and risk minimisation, transparency, accountability and liability, data privacy, and the need for human oversight. More recently, in February 2026, the government launched the Strategy for Artificial Intelligence in Healthcare for India (SAHI), which recognises the role of AI in clinical trials and recommends that trial designs and post-deployment learning mechanisms reflect the adaptive characteristics of AI.

Decentralised and hybrid clinical trials

One of the most apparent post-pandemic shifts has been the accelerated adoption of technology in the clinical trial lifecycle. Globally, decentralised and hybrid clinical trials – enabled by remote monitoring and digital tools – are becoming increasingly prevalent. These models can improve patient participation, expand access for patients in underserved areas, reduce logistical burdens and costs, and enhance overall efficiency of the clinical trial.

Embracing this trend, the revised GCP Guidelines released by the regulator in 2024 for public consultation expressly acknowledge the use of innovative digital health technologies such as wearables and sensors as data acquisition tools, and recommends their integration into existing healthcare infrastructure. While the revised GCP Guidelines are still in the process of being finalised, there has been a marked uptick in the use of such data acquisition tools to not only reduce the location-dependency of trials, but also to maximise the data points that the sponsor can rely on.

Real-world evidence and pharmacovigilance

The growing reliance on real-world evidence (RWE) by regulators and sponsors across jurisdictions is also gaining momentum in India. Although the Indian regulator has not issued any formal guidance on RWE, it is increasingly accepting data derived from non-trial settings for regulatory decision-making and for monitoring the post-marketing safety of drugs. In recent years sponsors have been permitted – in several reported instances – to undertake active post-marketing surveillance studies in lieu of Phase IV clinical trials, signalling increasing acceptance of RWE.

In parallel, the regulator has sought to strengthen the Pharmacovigilance Programme of India (PvPI). Currently, a marketing authorisation holder’s reporting obligations typically ease once the periodic safety update reporting requirements that form part of Phase IV activity conclude. Initiatives such as QR-code-based self-reporting mechanisms for patients, coupled with obligations on pharmaceutical companies to implement robust pharmacovigilance systems, reflect a shift towards a more proactive, RWE-driven safety monitoring framework.

Conclusion

The Indian clinical trial ecosystem has undergone significant transformation in recent years, driven by regulatory reforms, closer alignment with global standards, and the adoption of emerging technologies. These reforms are already yielding results: reportedly, between 2019 and 2024, the Indian clinical trial industry grew at a compound annual growth rate of 80 per cent, positioning India as the third-largest destination for clinical trials globally. Going forward, further harmonisation, strengthened oversight and continued agility vis-à-vis global trends will determine how effectively India sustains this momentum. Pertinently, despite the government’s laser-sharp focus on making India an attractive destination for foreign sponsors, it has not wavered in its commitment to upholding the rights and welfare of Indian subjects.