Commercial The New Drugs and Clinical Trials Rules, 2019 Bare Act by Commercial’s Editorial Board Latest Edition

This edition of The New Drugs and Clinical Trials Rules, 2019—as amended up to GSR 175(E), dated 9-3-2023, w.e.f. 13-3-2023—provides the complete regulatory framework governing the approval, conduct, and oversight of clinical trials and biomedical research in India.

Inside this comprehensive ₹595 volume

• Complete text of the New Drugs and Clinical Trials Rules, 2019 with all latest amendments incorporated

• Includes allied legislation:

– The Medical Devices Rules, 2017 (as amended vide GSR 409(E), dated 2-6-2023, w.e.f. 2-6-2023)

– The Drugs and Cosmetics Act, 1940 (as amended by The Jan Vishwas (Amendment of Provisions) Act, 2023 (18 of 2023), dated 11-8-2023, w.e.f. 31-12-2024 vide SO 1577(E), dated 28-3-2024)

• Covers:

– Requirements and procedures for grant of permission to conduct clinical trials

– Provisions for ethics committees, compensation, and post-trial access

– Regulation of new drugs, investigational new drugs, and bioavailability/bioequivalence studies

– Import, manufacture, and sale of new drugs for clinical use

– Regulatory standards for medical devices and related clinical investigations

• Section-wise and chapter-wise arrangement for quick reference

An essential resource for:

– Pharmaceutical companies, CROs (Contract Research Organisations), and biotech firms

– Medical researchers and clinical trial investigators

– Regulatory consultants and legal practitioners in drug and health law

– Academic institutions engaged in biomedical research