DIGITAL CONSENT AND AI-DRIVEN DRUG TRIALS: REVISITING PATIENT RIGHTS UNDER THE NDCT RULES 2019 IN THE AGE OF ARTIFICIAL INTELLIGENCE

Abstract

Pharmaceutical research in India is changing as a result of the incorporation of artificial intelligence into clinical trial procedures, such as patient recruiting, risk stratification, adverse-event monitoring, and remote or e-consent platforms. However, the regulatory framework controlling patient rights has not kept up. Through ethical committee registration and standardized consent procedures, the New Drugs and Clinical Trials (NDCT) Rules, 2019 improved participant safeguards. However, these measures were designed for human-mediated disclosure, not AI-mediated decision-making. Consent validity, data privacy, and accountability are three interconnected aspects of this regulatory gap that are examined in this paper's doctrinal, gap-analysis study. First, it argues that India's underdeveloped common-law doctrine of informed consent, compounded by the absence of AI-specific disclosure norms, leaves participants without meaningful notice of algorithmic involvement in their care. Second, it interrogates whether the Digital Personal Data Protection Act, 2023, read with the NDCT Rules, offers a proportionate legal basis for the large-scale linkage of health records, genetic data, and monitoring systems that AI driven trials require. Third, it examines the accountability vacuum created by opaque, “black-box” AI systems influencing eligibility and risk decisions, where liability among sponsors, investigators, and technology developers remains unassigned. Drawing comparative insight from the EU AI Act, the GDPR, and evolving United States FDA guidance, the paper proposes a reform framework to recalibrate India's consent, privacy, and liability standards for an AI-enabled clinical trial ecosystem, ensuring patient autonomy and protection keep pace with technological transformation in drug development.