Trusted Resource for Clinical Trials, Protocols & Progress
India’s clinical trial approvals are governed by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. NDCTR 2019 replaces earlier provisions under Schedule Y, codifying responsibilities and timelines for trial initiation, ethics committee review, sponsor obligations, and safety reporting.
Click to read the full article.
The regulatory approval and conduct of Phase 1 trials in India are governed by the Central Drugs Standard Control Organization (CDSCO) and outlined in the NDCTR 2019. Historically, India restricted Phase 1 trials of foreign molecules due to safety and ethical concerns. However, these limitations have been relaxed in recent years, particularly for drugs intended for life-threatening or rare diseases.
Click to read the full article.
The regulatory framework for generic drug development in India is primarily governed by the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules (NDCTR), 2019. For the clinical component, BA/BE studies are reviewed and approved by CDSCO, and conducted in accordance with Schedule Y and ICH E6 (GCP) principles.
Click to read the full article.
India lacks a specific “Orphan Drug Act” akin to the U.S. FDA or EU regulations, but steps have been taken through general frameworks such as the New Drugs and Clinical Trials Rules (NDCTR), 2019 and the National Policy for Rare Diseases (2021). Together, these provide a skeleton regulatory structure for rare disease research and drug development.
Click to read the full article.
The New Drugs and Clinical Trials Rules (NDCTR), 2019 form the backbone of clinical trial regulation in India, including the provisions related to investigational product management. While there is no standalone “Clinical Trial Supply Chain” regulation, several clauses under NDCTR, GSR 227(E), and CDSCO’s guidance documents cover key areas of handling, storage, transportation, and accountability of IMPs.
Click to read the full article.
India’s clinical trial regulations have progressively strengthened ethical protections for participants, especially in underserved populations. The New Drugs and Clinical Trials Rules (NDCTR), 2019 mandate stringent requirements for the informed consent process and documentation. Additionally, Rule 25 of the NDCTR outlines responsibilities for investigators and ethics committees in obtaining consent.
Click to read the full article.
The growth of CROs in India is governed by a mix of domestic legislation, international guidance, and evolving best practices. Regulatory oversight is provided primarily by the Central Drugs Standard Control Organization (CDSCO), under the New Drugs and Clinical Trials Rules, 2019 (NDCTR). These rules govern the operations of CROs involved in clinical trials, BA/BE studies, and data management.
Click to read the full article.
India’s regulatory framework for clinical trials, governed by the New Drugs and Clinical Trials Rules, 2019 (NDCTR), recognizes the importance of institutional sites like AIIMS and apex government hospitals. These institutions are often pre-qualified by the Central Drugs Standard Control Organization (CDSCO) for their infrastructure, GCP compliance, and track record.
Click to read the full article.
Clinical trial outsourcing in India is regulated under the New Drugs and Clinical Trials Rules (NDCTR), 2019, administered by the Central Drugs Standard Control Organization (CDSCO). These rules have streamlined trial approvals, mandated ethics committee registrations, and introduced timelines for applications submitted by foreign and Indian sponsors.
Click to read the full article.
India’s PMS system is grounded in the Drugs and Cosmetics Act, 1940 and Rules, 1945, supported by Schedule Y and further reinforced by the New Drugs and Clinical Trials Rules (NDCTR), 2019. Together, these regulations define the scope, responsibilities, and procedures for PMS in the Indian context.
Click to read the full article.
