Abstract

COMPARATIVE STUDY OF CLINICAL TRIAL APPROVAL TIMELINE IN INDIA AND USA

*Prasad Khandre, Shilpa Gawande, Anil Chandewar

Abstract

Bringing a new medicine from laboratory discovery to patient access is a complex, expensive, and highly regulated journey lasting twelve to fifteen years. This review provides a detailed comparative analysis of clinical trial approval frameworks in India and the United States, examining regulatory authorities, legal provisions, approval timelines, ethical oversight, documentation requirements, and special mechanisms such as accelerated approval and orphan drug incentives. India’s system, governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act and the New Drugs and Clinical Trials Rules 2019, emphasizes participant protection through mandatory compensation, expedited safety reporting, and post-trial access. The United States, regulated by the Food and Drug Administration under the Federal Food, Drug and Cosmetic Act and 21 CFR, offers a more centralized and faster approval pathway with a 30-day Investigational New Drug review and no application fees. Key differences also exist in compensation policies, safety reporting timelines, ethics committee registration, and regulatory fees. Recent Indian reforms, including the SUGAM portal and the 2024 amendment regulating clinical research organisations, signal a move toward greater efficiency and transparency. The findings suggest that while the US provides a speedier environment for clinical development, India demonstrates stronger ethical safeguards. Harmonisation efforts could benefit both systems and accelerate global access to safe and effective therapies.

Keywords: Clinical trial approval, CDSCO, FDA, India, NDCTR 2019, Regulatory framework, United States.