Regulatory Roadmap for Herbal Medicine

AUTHOR: G. Sudesh Kumar, Ph.D.
PUBLISHER: Business Horizons
ISBN: 9788190078894
YEAR: 2007 – First Edition
PAGES: 187
SIZE: 18.5 X 24.5 X 1.5 cm.
BINDING: Hard
LANGUAGE: English

ABOUT THE BOOK: The book is a roadmap for plant-derived medicine to move through regulatory, quality and intellectual property-related aspects either as a drug or a dietary supplement in global market place. It provides strategies to navigate through the available regulatory and market landscape, through innovation and standardization. A brief review of trends in patents based on herbal products and the legal hurdles faced in the protection of traditional medicines and marketing of these products in international markets is also covered.

ABOUT THE AUTHOR: G. Sudesh Kumar is currently Vice President (Analytical Division) at Vimta Labs Ltd, Hyderabad. Dr. Kumar led several research and technology teams at ICI Corporate Research Center, Thane, ICI Paints, Hyderabad, GE India Technology Center and GE Silicones India (Bangalore), GE Plastics, Netherlands in various leadership positions. He also has senior management experience at leading contract research and testing organizations and laboratory service providers like Shriram Institute for Industrial Research, Bangalore and Shiva Analytical (India) Pvt. Ltd, Bangalore. During the last decade, he established several state-of-the-art laboratory testing facilities, implemented ISO 9001/ IS017025 quality systems and helped migrate critical components of research and testing processes to Indian laboratories. Dr. Kumar is Six Sigma Black belt-trained and his current responsibilities include leading a multi-disciplinary contract research laboratories at Life Sciences Facility, Genome Valley, Hyderabad and implementation of Good Laboratory Practices.
Dr. Kumar received his Ph.D degree (1982) from Indian Institute of Science, Bangalore and did his post-doctoral work at University of Florida, Gainsville, Florida, USA and Bowling Green State University, Bowling Green, Ohio, USA. Dr. Kumar has 40 research publications, 5 patents and published three books; Biodegradable Polymers: Prospects and Progress (1987), Azo Functional Polymers (1993) and Outsourcing Laboratory-based Services: Inventing New Future for R&D and Testing" (2004)

CONTENTS:
Preface

CHAPTER – 1: CARING FOR HEALTH, NATURALLY!
Introduction
The New Ancient Thinking in Medicine
The Rise of Asia: Continental Drift
PharmAsia: Generic Solutions
Herbal Medicine: Aging Roots and Sprouting Branches
China: The Power of Chi
Ayurveda: Healing Trinity
Europe: Doctrine of Signatures
Modern Medicine: Designs from Nature
Better Pill to Swallow: Synthetic Drugs or Herbal?
Food versus Drug Administration of Herbs
Middle Path: Regulating Standards
Blossoming Beyond Borders

CHAPTER – 2: NATURE'S PHARMACY
Introduction
Ginseng: Root of Immortality Gingko: Total Recall?
Snakeroot Plant: The Original Tranquilizer
Bacopa: Memory Plus
Garlic: The Detoxifier
Aswagandha: Root of Rejuvenation
St. John's Wort: Prozac of plants Echinacea
Neem: Plant of the 21st century
Shakespearean Herbs: Food Act
Turmeric: Cure with Curry
Ephedra: Mormon Tea
Chocolate: Divine Treat
Beauty Care: Getting Physical
The Blenders Choice
Herbs are Bioreactors
Herbs in Soup: Stirred but not Shaken

CHAPTER – 3: QUALITY - TAKING ACTIVE MEASURES
Standardization: Phases Herbs have to grow Through
Good Agricultural Practices: GAP to Bridge
Identification and Selection: Born Identity
Codex: Phytosanitary Agreement
Good Manufacturing Practices
Good Laboratory Practices
Marking up Herbal Image?
USP Verified
Preclinical Testing
Clinical Trials
Industry Money Skews Drug Overviews?
Pharmacology: Active Site Model
Antioxidants: Radical Thinking
Alkaloid for Lowering Cholesterol
A New Leaf

CHAPTER – 4: FREE TRADE: TEST LOCALLY AND TRADE GLOBALLY
Introduction
ISO and GXP: Global Standard Practices
Documentation: Living History
Traceability
Calibration
Certified Reference Materials Validations
Method Selection and Validation
Measurement Uncertainty
Proficiency Testing
Clinical Trials
Double-Blind Studies
The Placebo Effect
Statistical Illusions
Meta-analysis
Mutual Recognition Agreement

CHAPTER – 5: FREE TREE AND INTELLECTUAL PROPERTY
Intellectual Property Rights and Wrongs?
Patents: Art of the Possible
Turmeric: Healing Wounds
Neem Campaign
Inca: Jungle Treasures
Aroma of Basmati Patent
Digital Defence: Past Forward
Sharing the Wealth
...and Saving Health

CHAPTER – 6: PHARMERS AND FARMACEUTICALS
Drug Discovery Process: New Paradigm
China: Exporting Success
Farming out to CROs
Biodiversity: Clear and Present Danger
Designs on Nature: farmaceuticals
Herbal Medicines on Tap?
Pharmers: Better the Devil you Grow?
Viva La Vida: Long Live Life
Further Reading

Index