As set forth in the 2019-CTRules and the Hdbk-ClinTrial, the Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for clinical trial oversight, …

Sep 3, 2025 · These rules were introduced to streamline the regulatory process, enhance participant protection, and align India's clinical research regulations with international standards.

The New Drugs and Clinical Trials Rules, 2019, further consolidated and modernized the regulatory framework, incorporating international best practices while addressing India-specific …

Sep 21, 2025 · This article provides an in-depth exploration of clinical trials in India, focusing on their legal structure, ethical dilemmas, international comparison, judicial interventions, and …

Learn how the regulatory framework in India shapes clinical trials. Key laws, CDSCO, ethics, and compliance explained for pharma & biotech.

Aug 27, 2025 · India clinical trials are regulated by the Central Drugs Standard Control Organization (CDSCO) under the New Drugs and Clinical Trials Rules (NDCTR) 2019. India’s …

May 2, 2025 · With the introduction of the New Drugs and Clinical Trials Rules, 2019 (NDCTR), India has streamlined its clinical trial approval processes, aiming to align more closely with …

Dec 30, 2024 · proval mechanisms. India's recent regulations align with international standards and aim to improve efficiency and patient safety in clinical trials. The comparison …

The Clinical Trials Registry- India (CTRI) has been set up by the ICMR's National Institute of Medical Statistics (NIMS) and is funded by the Department of Science and Technology (DST) …

Nov 25, 2024 · At the heart of these reforms is the need to improve clinical trial operations, encourage investment in research, and meet international standards for the development of …