Singh - Regulatory and Pharmacological Basis of Ayurvedic Formulations

Regulatory and Pharmacological Basis of Ayurvedic Formulations

Amritpal Singh Saroya

Herbal Consultant Punjab India

CRC Press

Taylor & Francis Group

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2016 by Taylor & Francis Group, LLC

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Printed on acid-free paper Version Date: 20160401

International Standard Book Number-13: 978-1-4987-5094-3 (Hardback)

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Library of Congress Cataloging-in-Publication Data

Names: Amritpal Singh, 1971- , author.

Title: Regulatory and pharmacological basis of ayurvedic formulations / Amritpal Singh Saroya.

Description: Boca Raton : Taylor & Francis, 2017. | Includes bibliographical references and index.

Identifiers: LCCN 2016010614 | ISBN 9781315351339 (hardcover : alk. paper) Subjects: | MESH: Medicine, Ayurvedic | Materia Medica--pharmacology | Drug and Narcotic Control | Drug Compounding | Chemistry, Pharmaceutical Classification: LCC R733 | NLM WB 55.A9 | DDC 615.5/38--dc23 LC record available at http://lccn.loc.gov/2016010614

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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 fulfil 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)

Regulatory affairs (RA) is also known as government affairs. A regulatory affair is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, banking, telecom, etc. Regulatory affairs have a very specific meaning within the healthcare industries including pharmaceuticals, medical devices, biologic and functional foods.

Regulatory affairs are a crucial function in the pharmaceutical industry. Industries like pharmaceuticals, biologics, food and medical equipment can be uncertain if the new products and methods are not tested and checked for functionality with great vigilance before being publicised.

The first and foremost factor for the pharmaceutical sector has been always in the efficacy and cost-effectiveness of the drug contributing to the success in the market. Therefore, effective administration and superintendence of regulatory affairs actions plays a crucial role in the economy of the corporation.

The regulatory affairs professional is the only person who is completely responsible for such activities developing distinct rejoinders to regulatory authorities who want an organization to hold products in compliance and retain satisfactory data in support of applications that have been made for the registration of the products.

Herbal medicines which have formed the basis of health care throughout the world since the earliest days of mankind are still widely used, and have considerable importance in international trade. Recognition of their clinical, pharmaceutical and economic value is still growing, although this varies widely between countries.

Medicinal plants are important for pharmacological research and drug development, not only when plant constituents are used directly as therapeutic agents, but also as starting materials for the synthesis of drugs or as models of pharmacologically active compounds. Regulation of exploitation and exportation is therefore essential, together with international cooperation and coordination for the conservation of these plants so as to ensure their availability in the future.