Regulatory Roadmap for Herbal Medicines

About Book

ISBN 8190078895
Presentation Hardbound, 199 Pages
Edition 1st Edition 2007
Weight 0.55 Kg
Author Dr G. Sudesh Kumar
Price USD 50
Availability In Stock

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.

Author

G. Sudesh Kumar, Ph. D is Business Manager, SGS India Pvt. Ltd, Gurgaon dealing in testing, certification and inspection and has over 25 years experience to his credit.

CONTENTS

Preface

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

 

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

 

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

 

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

 

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

 

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


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