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Commercial's The New Drugs and Clinical Trials Rules, 2019 — Bare Act with short comments, published by Commercial Law Publishers (India) Pvt. Ltd. 2027 Edition.

This volume puts the three instruments that govern pharmaceutical regulation in India between one set of covers: the New Drugs and Clinical Trials Rules, 2019, the Medical Devices Rules, 2017 and the parent Drugs and Cosmetics Act, 1940. In practice they are never applied separately. A clinical trial application engages the 2019 Rules and the Act; a device approval engages the 2017 Rules and the Act; and the offence and penalty provisions for all of it sit in the Act.

The 2027 edition is current to a cluster of amendments that landed close together:

• The New Drugs and Clinical Trials Rules, 2019 as amended vide GSR 50(E) dated 21-1-2026, with effect from 21-4-2026.
• The Medical Devices Rules, 2017 as amended vide GSR 744(E) dated 14-8-2026, with effect from 19-8-2026.
• The Drugs and Cosmetics Act, 1940 as amended by the Jan Vishwas (Amendment of Provisions) Act, 2026 (8 of 2026) dated 7-4-2026 — with the remaining provisions in force from 1-7-2026 vide SO 3362(E) dated 23-6-2026, and certain provisions coming into force from 30-6-2027 vide SO 3286(E) dated 22-6-2026.

That last point deserves emphasis. The Jan Vishwas Act decriminalises and recasts a range of penalty provisions, and it commences in stages — part of it already in force and part of it not until 30 June 2027. Anyone advising on liability under the Drugs and Cosmetics Act has to know which provision is in force on the date in question, and a text that does not set out the commencement notifications cannot answer that.

Key Features

• The New Drugs and Clinical Trials Rules, 2019 in full, as amended to GSR 50(E) w.e.f. 21-4-2026.
• The Medical Devices Rules, 2017, as amended to GSR 744(E) w.e.f. 19-8-2026.
• The Drugs and Cosmetics Act, 1940, as amended by the Jan Vishwas (Amendment of Provisions) Act, 2026.
• The staged commencement of the Jan Vishwas amendments set out with the notifications — SO 3362(E) for the provisions in force from 1-7-2026 and SO 3286(E) for those from 30-6-2027.
• Short comments alongside the bare text, in the Commercial's bare act format.
• 2027 Edition, from Commercial Law Publishers (India) Pvt. Ltd., with Lexlegis.ai as knowledge partner.
• Three instruments in one volume, at bare-act price rather than commentary price.

Coverage

The New Drugs and Clinical Trials Rules, 2019

• Definitions and scope — new drug, investigational new drug, bioavailability and bioequivalence study, and the categories of clinical trial.
• Ethics Committees — registration, composition, functions and the review of trials and biomedical research.
• Clinical trial approval — the application, the Central Licensing Authority, timelines and deemed approval, and the conditions attached.
• Conduct of a clinical trial — informed consent, the audio-visual recording requirement, protocol and amendments, and the responsibilities of the sponsor and investigator.
• Compensation for injury or death in a clinical trial, and the procedure for determining it.
• Serious adverse events — reporting obligations and timelines.
• Bioavailability and bioequivalence studies, and the approval of centres.
• Import and manufacture of new drugs and investigational new drugs for trial, examination, test and analysis.
• Post-trial access, inspection, suspension and cancellation of permission, and appeals.
• The Schedules, including the forms and fee schedules.

The Medical Devices Rules, 2017

• Classification of medical devices by risk, and notified devices.
• Licensing of manufacture, import, sale and distribution.
• Quality management system, labelling and the Essential Principles.
• Clinical investigation of investigational medical devices and clinical performance evaluation of in vitro diagnostics.
• Registration of notified bodies, audit and inspection.

The Drugs and Cosmetics Act, 1940

• The regulatory authorities — the Drugs Technical Advisory Board, the Central Drugs Laboratory and the Drugs Consultative Committee.
• Import of drugs and cosmetics, and the prohibitions.
• Manufacture, sale and distribution — licensing, Government Analysts and Inspectors, and their powers.
• Misbranded, adulterated and spurious drugs and spurious cosmetics.
• Offences and penalties as recast by the Jan Vishwas (Amendment of Provisions) Act, 2026, with compounding and adjudication.
• Ayurvedic, Siddha and Unani drugs under the Act.

Who Should Buy This Book?

• Regulatory affairs professionals in pharmaceutical and medical device companies.
• Clinical Research Organisations, sponsors and principal investigators, and clinical trial sites.
• Ethics Committee members and secretariats.
• Drug Inspectors, Government Analysts and State and Central Drugs Control officials.
• Advocates in drug regulatory, product liability and prosecution matters under the Drugs and Cosmetics Act.
• Medical device manufacturers and importers, and their compliance teams.
• Hospital administrators and quality teams hosting trials.
• Pharmacy, pharmacology and clinical research students and institutions.
• Company secretaries and compliance officers in the life sciences sector.

Why Choose This Book?

The practical case for this volume is consolidation plus currency. The 2019 Rules, the 2017 Device Rules and the 1940 Act are published separately by the Government and amended separately by notification, and keeping three sets of amendments current from the Gazette is a job in itself. A bare act that does the consolidation for you, at ₹695 rather than commentary prices, pays for itself the first time it saves an hour.

The particular reason for this edition is the Jan Vishwas (Amendment of Provisions) Act, 2026. It changes the penalty regime under the Drugs and Cosmetics Act, and it does so in stages, with one tranche in force from 1 July 2026 and another not until 30 June 2027. Advising on exposure under the Act now requires knowing which provision applies on which date — and this edition prints the commencement notifications, which is exactly the information an older text cannot give you.