The New Drugs and Clinical Trials Rules, 2019

Commercial’s The New Drugs and Clinical Trials Rules, 2019 (2027 Edition) is a comprehensive legal reference presenting the statutory provisions governing new drugs, clinical trials, and related regulatory requirements in India. Published by Commercial Law Publishers (India) Pvt. Ltd., this edition reproduces the New Drugs and Clinical Trials Rules, 2019, notified vide G.S.R. 227(E), dated 19 March 2019, with Chapter IV effective from 15 September 2019, as specified on the book cover. It incorporates the amendment vide G.S.R. 50(E), dated 21 January 2026, effective from 21 April 2026, and includes the Medical Devices Rules, 2017, and the Drugs and Cosmetics Act, 1940, with the amendments and notifications identified on the cover.

The book provides a consolidated statutory reference for understanding the legal framework governing drug development, clinical research, regulatory approvals, medical devices, and pharmaceutical compliance. With the bare acts and rules accompanied by short comments, it helps readers navigate the relevant provisions and understand the regulatory obligations applicable to pharmaceutical companies, clinical research organisations, medical device manufacturers, healthcare professionals, and other stakeholders in the healthcare sector.

The content includes the following key legislations and regulatory materials:

• The New Drugs and Clinical Trials Rules, 2019, including the amendments specified on the cover

• Provisions governing the approval and regulation of new drugs

• Regulatory requirements relating to clinical trials and clinical investigations

• Requirements concerning ethics committees and the protection of clinical trial participants

• Rules relating to informed consent, safety monitoring, and reporting of adverse events

• Regulatory procedures for clinical trial permissions and related applications

• The Medical Devices Rules, 2017, as amended vide GSR 744(E), dated 14 August 2026, effective from 19 September 2026

• The Drugs and Cosmetics Act, 1940, incorporating the Jan Vishwas (Amendment of Provisions) Act, 2026, and the notifications specified on the cover

• Supplementary statutory provisions relating to the regulation, manufacture, import, distribution, and sale of drugs and medical devices

• Relevant regulatory requirements for pharmaceutical research, product approvals, and healthcare compliance

This edition is particularly suitable for:

• Law students and academicians studying pharmaceutical law, healthcare regulation, and medical jurisprudence

• Advocates and legal practitioners handling pharmaceutical regulatory matters and clinical trial disputes

• Pharmaceutical companies and regulatory affairs professionals responsible for drug approvals and compliance

• Clinical research organisations and investigators involved in clinical trials

• Medical device manufacturers and importers seeking to understand applicable regulatory requirements

• Healthcare professionals, researchers, and ethics committee members involved in clinical research

• Regulatory consultants and compliance officers working in the pharmaceutical and medical device industries

Whether used for academic study, regulatory compliance, legal research, or professional practice, the 2027 edition of Commercial’s The New Drugs and Clinical Trials Rules, 2019 offers a consolidated reference to important drug and clinical research regulations, the Medical Devices Rules, 2017, and the Drugs and Cosmetics Act, 1940, with short comments and the amendments identified on the book cover.