ILBCO�s New Drugs and Clinical Trials Rules, 2019 � 5th Edition, 2026 by Rajan Nijhawan is a practical reference book covering the regulatory framework governing new drugs and clinical trials in India. The 2026 edition includes updated reference material and useful regulatory information for students, pharmaceutical professionals, researchers, legal practitioners, regulatory professionals and others working with drug and clinical-trial regulations.
The book brings together important information relating to approved new drugs, clinical trials, CDSCO, Central Drug Testing Laboratories, drug controllers and regulatory authorities, along with frequently asked questions and useful procedural information.
New Drugs and Clinical Trials Rules, 2019 � 5th Edition, 2026, revised and published by Rajan Nijhawan, is a comprehensive reference on India's regulatory framework for new drugs and clinical trials. It covers approved new drugs, clinical trials, CDSCO, Central Drug Testing Laboratories, FAQs, regulatory offices, RTI procedures and drug controllers, making it a useful reference for pharmacy, pharmaceutical, clinical research and regulatory affairs professionals.

Core Subjects / Topics

� New Drugs and Clinical Trials Rules, 2019
� New Drug Approvals
� List of Approved New Drugs � 1961 to 2025
� Clinical Trials
� CDSCO � Central Drugs Standard Control Organization
� Central Drug Testing Laboratories
� Frequently Asked Questions (FAQs) on New Drugs & Clinical Trials
� CDSCO Officials / Who�s Who
� Central & Zonal Drug Regulatory Offices
� CPIA at CDSCO
� HQ & RDTL
� RTI Application Form
� Drug Controllers
� Regulatory and Approval Procedures
� Drug Control Administration

Key Features

� 5th Edition, 2026
� Revised and published by Rajan Nijhawan
� Covers the New Drugs and Clinical Trials Rules, 2019
� Includes approved new-drug information up to 2025
� Useful FAQs for quick reference
� Contains information concerning CDSCO and drug-testing laboratories
� Includes regulatory-office and drug-controller information
� Useful reference for pharmaceutical, clinical research and regulatory affairs professionals

This Book is Ideal For

� Pharmacy Students
� Pharmaceutical Professionals
� Clinical Researchers
� Clinical Trial Professionals
� Regulatory Affairs Professionals
� Drug Regulatory Authorities
� Legal Professionals
� Healthcare Professionals
� Pharmaceutical Companies
� Researchers
� Academicians
� Advocates