In accordance with the provisions of the 2019-CTRules, the Drugs Controller General of India (DCGI) heads CDSCO, and is responsible for granting permission for clinical trials to be conducted and for …

he Central Drugs Standard Control Organisation (CDSCO)under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory …

The mission of the Clinical Trials Registry-India (CTRI) is to ensure that all clinical trials conducted in India are prospectively registered, i.e. before the enrolment of the first participant.

May 2, 2025 · Explore CDSCO guidelines for clinical trials and drug approvals in India, covering regulatory processes, compliance requirements, and post-approval obligations.

Aug 8, 2024 · Thus, the clinical trials have to be regulated to protect the Indian clinical trial market. Indian clinical trial regulations are in place to safeguard trial participants and to improve the quality of …

Jan 13, 2025 · Explore the evolving regulatory framework of clinical trials in India, focusing on CDSCO's role and subject protection.

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 evolving …

In India, obtaining an import license for clinical trial drugs under Form CT-16 is essential for ensuring compliance with local regulations. This article serves as a comprehensive step-by-step guide aimed …

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

Sep 3, 2025 · This regulation mandates registration with the Clinical Trial Registry of India prior to conducting any clinical research for biomedical and health research, obtaining informed consent from …