Regulatory and Pharmacological Bases of Ayurvedic Formulations PDF
Preview Regulatory and Pharmacological Bases of Ayurvedic Formulations
Regulatory and Pharmacological Basis of Ayurvedic Formulations TThhiiss ppaaggee iinntteennttiioonnaallllyy lleefftt bbllaannkk Regulatory and Pharmacological Basis of Ayurvedic Formulations Amritpal Singh Saroya Herbal Consultant Punjab India p, A SCIENCE PUBLISHERS BOOK GL--Prelims with new title page.indd ii 4/25/2012 9:52:40 AM GL--Prelims with new title page.indd ii 4/25/2012 9:52:40 AM CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2016 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Version Date: 20160525 International Standard Book Number-13: 978-1-4987-5096-7 (eBook - PDF) This book contains information obtained from authentic and highly regarded sources. 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For permission to photocopy or use material electronically from this work, please access www.copyright. com (http://www.copyright.com/) or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. CCC is a not-for-profit organization that provides licenses and registration for a variety of users. For organizations that have been granted a photocopy license by the CCC, a separate system of payment has been arranged. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com PREFACE We feel happy and satisfied in presenting this book titled Regulatory and Pharmacological Issues of Ayurvedic Formulations before the pharmacy fraternity. Research in Ayurvedic medicine is a buzzword and several national and international companies of repute are investing funds for novel and cost-effective drug-discovery from natural sources. Ayurvedic Pharmaceutical Sciences is an upcoming discipline and is expected to play a pivotal role in future healthcare industry. The idea of writing a book on such a vast topic was an on-going and vigorous effort. Standard and practical books on the pharmaceutical value of Ayurvedic Medicine have been lacking. Standard books incorporating information on standardisation, pre-clinical (animal) and clinical studies and toxicity data of widely used Ayurvedic formulations have been a missing link. The book has two distinct sections (evident from the title) Regulatory: This section deals with regulatory affairs related to Ayurvedic formulations. The introductory chapter throws light on regulatory affairs. Succeeding chapters are correlated to Ayurvedic pharmacopoeia, Drug and Cosmetic Act, Licensing and GMP issues related to the Ayurvedic drug industry, pharmacovigilance, genotoxic potential of Ayurvedic formulations and so on. This section shall serve as benchmark for the Ayurvedic drug industry. Pharmacological: Section B is dedicated to pharmacological investigations done on selected Ayurvedic formulations. This section highlights pharmaceuticals and standardisation issues of Ayurvedic formulations. Animal, toxicological and clinical studies have been arranged under one roof thereby making the section multi-dimensional. This section shall fulfi l requirement of students, researchers and academicians. I sincerely hope that this book will be accepted by the Ayurvedic and pharmacy fraternity. Dr. Amritpal Singh Saroya MD (Ayurveda); MSc (Medicinal Plants) TThhiiss ppaaggee iinntteennttiioonnaallllyy lleefftt bbllaannkk CONTENTS Preface v PART A: AYURVEDA AND REGULATORY AFFAIRS 1. Introduction to Regulatory Affairs 3 2. Introduction to Ayurvedic Pharmacopoeia of India 8 3. Drugs and Cosmetic Act and Ayurvedic Drugs 14 4. Ayurvedic Drug Manufacturing License 22 5. Good Manufacturing Practices for ASU Medicines (Schedule-T) 26 6. Ayurvedic Drug Industry 37 7. Pharmacovigilance of Ayurvedic Drugs 41 8. Heavy Metal Content of Ayurvedic Formulations 46 9. Genotoxic Potential of Ayurvedic Formulations 54 10. Aristolochic Acid Distribution in Ayurvedic Formulations 55 11. Clinical Trials in Ayurveda 58 12. National Ayush Mission 64 13. Ayurvedic Pharmacy Education 67 14. Patent and IPR Issues of Ayurvedic Formulations 70 15. Ayurvedic Pharmacoepidemiology 75 16. Voluntary Certifi cation Scheme for Ayush Products 77 17. Ayurvedic Databases 88 18. Medicinal Plants Division of Indian Council for Medical Research 90 Bibliography (Part A) 93 viii Regulatory and Pharmacological Basis of Ayurvedic Formulations PART B: PHARMACOLOGICAL INVESTIGATIONS ON AYURVEDIC FORMULATIONS A-Z of Standardisation, Pre-Clinical, Clinical and Toxicological Data 99 Bibliography (Part B) 192 Notifi cations 213 Forms 224 Tables 227 Lists 240 Annexures 251 Index 257 PART A AYURVEDA AND REGULATORY AFFAIRS
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