New Drugs and Clinical Trials Rules, 2019

New Drugs and Clinical Trials Rules, 2019

Rs. 476.00 Rs. 595.00
Author : Commercial Law Publishers
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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

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Shipping
Orders are shipped within 3–5 working days (exceptions may occur). Deliveries within Delhi usually take 3–5 working days post-shipment, while deliveries outside Delhi may take 4–5 working days. International shipping is not available at present. Once your package has been dispatched, you will receive a confirmation email with a tracking number to monitor your order.

Returns
We do not accept returns or exchanges for books once sold. A return or replacement is only possible if the book delivered is damaged or if the wrong book has been sent. In such cases, customers are requested to contact us within 7 days of delivery with order details and proof (such as a photo of the book). Refunds will be processed once the returned books are received and inspected, and the amount will be credited in the original form of payment within 7 working days. Shipping charges will not be refunded unless the return is due to our error.

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About the author

Commercial Law Publishers

Commercial Law Publishers

Commercial has been bold enough to bring out Books, Commentaries and Referencers on hitherto untouched subjects like Legal Metrology. It has a record number of publications on excise and customs; several titles on direct taxes as well as Sales Tax.

Commercial, in a way has brought about a reform in legal publishing by bringing out high quality publications at affordable prices and is an highly ethical business enterprise. Commercial has withstood the market competition successfully over the years including competition from Foreign publishers and strives its best to serve the legal and corporate professionals better and better every day with its novel ideas and business strategy. Commercial is backed by a team of highly competent in-house professional experts supplemented by high profile authors who have stood by it for decades.

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