The New Drugs and Clinical Trials Rules, 2019 is a book on Conferenza, priced at ₹476 (20% off MRP ₹595). Published by Commercial Law Publishers. Order online with fast delivery across India.
- Price
- ₹476 · 20% off
- Edition
- 2024
The New Drugs and Clinical Trials Rules, 2019
Commercial Law Publishers
Book Specifications
- Edition
- 2024
- Amendments up to
- GSR 175(E), dated 9-3-2023, w.e.f. 13-3-2023
- Format
- Printed book
About this book
Complete regulatory framework for clinical trials and biomedical research in India. Covers the New Drugs and Clinical Trials Rules 2019 with latest amendments, plus allied legislation on medical devices and drugs. For pharmaceutical companies, researchers, regulators, and legal practitioners.
At a glance
| Edition | 2024 |
| Amendments up to | GSR 175(E), dated 9-3-2023, w.e.f. 13-3-2023 |
| Format | Printed book |
What's inside
- Complete text of the New Drugs and Clinical Trials Rules, 2019 with all amendments
- The Medical Devices Rules, 2017 (amended up to 2-6-2023)
- The Drugs and Cosmetics Act, 1940 (amended up to 31-12-2024)
- Requirements and procedures for clinical trial permissions
- Ethics committees, compensation, and post-trial access provisions
- Section-wise and chapter-wise arrangement for quick reference
Who should buy this
- Pharmaceutical companies and contract research organisations
- Clinical trial investigators and medical researchers
- Regulatory consultants and legal practitioners in drug law
- Academic institutions conducting biomedical research
Publisher's description
This 2024 edition of The New Drugs and Clinical Trials Rules, 2019—as amended up to GSR 175(E), dated 9-3-2023, w.e.f. 13-3-2023—provides the complete regulatory framework governing the approval, conduct, and oversight of clinical trials and biomedical research in India.
Inside this comprehensive ₹595 volume
• Complete text of the New Drugs and Clinical Trials Rules, 2019 with all latest amendments incorporated
• Includes allied legislation:
– The Medical Devices Rules, 2017 (as amended vide GSR 409(E), dated 2-6-2023, w.e.f. 2-6-2023)
– The Drugs and Cosmetics Act, 1940 (as amended by The Jan Vishwas (Amendment of Provisions) Act, 2023 (18 of 2023), dated 11-8-2023, w.e.f. 31-12-2024 vide SO 1577(E), dated 28-3-2024)
• Covers:
– Requirements and procedures for grant of permission to conduct clinical trials
– Provisions for ethics committees, compensation, and post-trial access
– Regulation of new drugs, investigational new drugs, and bioavailability/bioequivalence studies
– Import, manufacture, and sale of new drugs for clinical use
– Regulatory standards for medical devices and related clinical investigations
• Section-wise and chapter-wise arrangement for quick reference
An essential resource for:
– Pharmaceutical companies, CROs (Contract Research Organisations), and biotech firms
– Medical researchers and clinical trial investigators
– Regulatory consultants and legal practitioners in drug and health law
– Academic institutions engaged in biomedical research
Frequently asked questions
What is The New Drugs and Clinical Trials Rules, 2019?+
Complete regulatory framework for clinical trials and biomedical research in India. Covers the New Drugs and Clinical Trials Rules 2019 with latest amendments, plus allied legislation on medical devices and drugs. For pharmaceutical companies, researchers, regulators, and legal p
How much does The New Drugs and Clinical Trials Rules, 2019 cost?+
The New Drugs and Clinical Trials Rules, 2019 is available for ₹476 (MRP ₹595) on Conferenza, with fast delivery.
Which edition of The New Drugs and Clinical Trials Rules, 2019 is this, and is it the latest?+
This listing is the 2024. Editions are revised for the latest syllabus and amendments — the current edition and its full details are shown on this page.
Is The New Drugs and Clinical Trials Rules, 2019 good for self-study?+
The New Drugs and Clinical Trials Rules, 2019 is a book, suitable for self-study and revision. Pair it with practice and past papers for complete exam preparation.
Is The New Drugs and Clinical Trials Rules, 2019 available as a free PDF download?+
The New Drugs and Clinical Trials Rules, 2019 is a paid book on Conferenza, delivered fast across India. For free PDFs — study material, RTPs, MTPs and suggested answers — visit https://conferenza.in/downloads.