ILBCO’s New Drugs and Clinical Trials Rules, 2019 (4th Edition, 2024) by Rajan Nijhawan

The 4th Edition (2024) of ILBCO’s New Drugs and Clinical Trials Rules, 2019 by Rajan Nijhawan provides a comprehensive and updated compilation of the New Drugs and Clinical Trials Rules, 2019, framed under the Drugs and Cosmetics Act, 1940.

This edition includes all latest amendments, notifications, and guidelines issued by the Ministry of Health & Family Welfare and Central Drugs Standard Control Organization (CDSCO) up to 2024.
It covers provisions related to new drug approval, clinical trials, ethics committees, bioavailability and bioequivalence studies, biomedical and phytopharmaceutical research, orphan drugs, and post-trial access.

A valuable reference for pharmaceutical professionals, researchers, regulatory consultants, CROs, ethics committees, legal experts, and students involved in drug development and regulatory affairs.