Table Of ContentRegulatory 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
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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
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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
