The New Drugs and Clinical Trials Rules, 2019

This 2024 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