Clinical Research

The New Drugs and Clinical Trials Rules, 2019 (NDCTR) marked a major shift in India’s regulatory framework for approving new drugs, conducting clinical trials, and monitoring drug safety. Before NDCTR, the country’s system — primarily governed by Schedule Y of the Drugs and Cosmetics Rules — faced criticism for its lack of clear timelines, insufficient guidance on advanced therapies, and weak oversight of ethics committees. NDCTR introduced structured approval timelines, expanded definitions to cover biologics, cell and gene therapies, enhanced participant safeguards, and established mandatory ethics committee registration. The adoption of the Central Drugs Standard Control Organization’s (CDSCO) SUGAM portal further streamlined submissions, tracking, and communications, significantly reducing administrative delays. This review discusses NDCTR’s historical background, key features, and its effects on clinical trials and pharmaceutical R&D, with real-world examples including the accelerated approval of Itolizumab during COVID-19, the indigenous DNA vaccine ZyCoV-D, and India’s first CAR-T therapy NexCAR19. Ethical and regulatory implications are analysed alongside criticisms — such as over-reliance on foreign data and variability in ethics committee capacity. Finally, the paper explores opportunities to strengthen India’s position as a global hub for cost-effective, high-quality clinical research.