The New Drugs and Clinical Trials Rules, 2019

The New Drugs and Clinical Trials Rules, 2019 serves as a comprehensive resource for understanding India’s updated regulatory framework for drug approvals and clinical trials. The book offers detailed explanations of key provisions, including requirements for conducting clinical trials, regulatory approvals for new drugs, ethical considerations, and patient safety safeguards.

With an emphasis on practical applicability, the text guides readers through procedural mandates, CDSCO approvals, documentation standards, and compliance measures. Case examples, real-world applications, and statutory references provide clarity on complex regulatory provisions. This edition is invaluable for legal professionals, pharmaceutical companies, clinical researchers, and students seeking a thorough understanding of the legal and regulatory landscape of drug development in India.

Structured for ease of reference, the book combines statutory commentary with analytical insights, ensuring readers can quickly navigate and interpret the rules relevant to clinical trials and new drug approvals. It addresses both administrative and corporate compliance aspects, making it essential for practitioners in the pharmaceutical and healthcare sectors.