New Drugs and Clinical Trials Rules, 2019 | With Allied Laws

New Drugs and Clinical Trials Rules, 2019 | With Allied Laws revised and published by Rajan Nijhawan is a comprehensive legal and regulatory reference covering India’s framework governing new drugs, clinical trials, pharmaceutical approvals, and medical research compliance. Published by ILBCO India, this 5th Edition 2026 incorporates updated legal provisions, approved new drugs data, regulatory notifications, FAQs, and practical compliance information relevant to the pharmaceutical and healthcare industries.

The book contains detailed coverage of the New Drugs and Clinical Trials Rules, 2019 along with allied laws, procedural guidelines, and important regulatory references associated with CDSCO and drug control administration in India. It includes lists of approved new drugs from 1961 to 2025, frequently asked questions on clinical trials and drug approvals, RTI application formats, lists of drug controllers, central drug testing laboratories, and institutional regulatory references.

Designed for pharmaceutical companies, clinical research organizations, regulatory affairs professionals, healthcare lawyers, compliance officers, medical researchers, academicians, and law students, this publication serves as an important practical handbook for understanding India’s drug approval and clinical trial ecosystem.

The book is particularly useful for professionals dealing with pharmaceutical regulation, ethics compliance, medical testing approvals, drug licensing, healthcare governance, and regulatory documentation in India’s rapidly evolving healthcare sector.