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Quality Control and Standardization of Ayurvedic Medicines (A Book for BAMS, B.Pharma (Ay.) & MD (Ay.) Students)

Quality Control and Standardization of Ayurvedic Medicines (A Book for BAMS, B.Pharma (Ay.) & MD (Ay.) Students)
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About the Book   The old syllabus which our graduates were going through had many loopholes. The graduates of ayurveda undoubtedly get the ancient knowledge of medicines and knowledge of herbal drugs and their preparation, but they do not get the proper knowledge about the recent advancements in ayurvedic sciences. Theoretical knowledge is one thing but utilization of that in practice is different. But the recent syllabus of ayurveda, particularly of Dra...

About the Book

 

The old syllabus which our graduates were going through had many loopholes. The graduates of ayurveda undoubtedly get the ancient knowledge of medicines and knowledge of herbal drugs and their preparation, but they do not get the proper knowledge about the recent advancements in ayurvedic sciences. Theoretical knowledge is one thing but utilization of that in practice is different. But the recent syllabus of ayurveda, particularly of Dravya Guna and Rasa Shastra & Bhaisajya Kalpana deals with proper identification of plants as per modern techniques and also use of them in preparation of medicines in a proper manner so that quality of it is maintained and the patient gets a standard medicine with proper potency.

 

The book, Quality control & standardization of ayurvedic medicines deals with all these points as per new syllabus and is going to be very useful to all ayurvedic graduates and post graduates particularly of Dravya Guna and Rasa Shastra & Bhaisajya Kalpana. This book will open new dimensions for the students who have view for further development of ayurveda.

 

About the Author

 

The authors of this book are postgraduates in the subject of Rasa Shastra & Bhaishajya Kalpana and are currently working in the beautiful valley of Dehradun in Himalayiya ayurvedic college. Dr. Devendra joshi had completed his M.D. from Rishikul ayurvedic college Haridwar. He has also worked in swami ramdeva’s Divya yoga pharmacy as production incharge. He worked in Uttaranchal Ayurvedic college as lecturer and is presently designated as ‘Reader’ in Himalayiya ayurvedic college. Dr. Geeta Joshi has done her M.D. from Rishikul ayurvedic college, Haridwar and is presently working as lecturer in Himalayiya ayurvedic college.

 

Foreword

 

Ayurved, the Science of life, is an Eternal Science and is claimed in the samhitas as Anaadi and Saashwat. It pioneered the whole medical systems at one time when the physicians used to treat their patients by preparing and dispensing the medicines. But change is everywhere and with the increased demand due to explosion of population the manufacturing trend also switched over to machines from the hands of physicians. Because of this and also due to the supremacy of the western medicine the importance of this system has little bit tarnished.

 

But in the recent past, it is amazing to note that on one hand we can see innovations in the field of science and technology and on the other hand we observe a return to the ancient tradition. Public at global level are waking up and looking towards the importance of the herbal medicines Now It is getting popularized in developing and developed countries owing to its natural origin and lesser side effects.

 

In this changed scenario herbal medicines are being manufactured on a large scale in mechanical units, where manufacturers as well as patients come across many problems such as availability of good quality raw material, authentication of raw material, availability of standards, proper standardization methodology of single drugs and formulations, quality control parameters, etc.

 

Hence various organizations like WHO etc have evolved certain guidelines for cultivation, harvest, storage, manufacture and quality control in the form of rules and laws. But these works are scattered and available at different web addresses and it is difficult for the students and others associated with the system, to surf and gather.

 

The author of this book has made an effort to collect and compile all such relevant information starting from Good Ag. Practices, Good manufacturing Practices, Good pharmacovigilance Practices etc at one place which I feel highly beneficial for students in particular and Ayurvedic fraternity in general.

 

I wish the author all the best for this endeavor.

 

Preface

 

Herbal medicine, Botanical medicine or Herbology, is the use of plants, in a wide variety of forms, for their therapeutic value. Herbal plants contain a variety of chemical compounds that act upon the body and are used to prevent or treat disease or promote health and well-being. Herbal drugs have increasingly been used worldwide during the last few decades as evidenced by rapidly growing global and national markets of herbal drugs. According to WHO estimates, the present demand for medicinal plants is about US $14 billion a year and by the year 2050 it would be about US $ 5 trillion.

 

Out of 47,000 species of plants reported to occur within India, 15000 are known to have medicinal uses, this proportion of medicinal plants is the highest known in any other country against the existing flora of that country.7000 Medicinal Plants sps. are described in Ay, followed by the Sand U medical systems.

 

Plants are a major source of natural products. Since ancient time, people have been searching for medicinal plants to treat various diseases .Apart from India and China, where traditional system of medicine has been used from a long time, western countries are also showing a great interest in herbal medicine. This global interest in herbal medicine system is mainly due to very low side effects as opposed to an exhausted immune system due to extended use of allopathic medicine.

 

Currently, approximately 25% of drugs are derived from plants, and many others are synthetic analogues built on prototype compounds isolated from plant species in modern pharmacopoeia Globally, there has been an unparalleled growth in the plant-derived medicinally useful formulations, drugs and health-care products, its market covering more than 60% products derived from plant origin. India exhibits remarkable outlook in modern medicines that are based on natural products besides traditional system of Indian medicines. Almost, 70% modern medicines in India are derived from natural products. Medicinal plants play a central role not only as traditional medicines but also as trade commodities, meeting the demand of distant markets. Ironically, India has a very small share (1.6%) of this ever-growing global market. To compete with the growing market, there is urgency to expeditiously utilize and scientifically validate more medicinally useful plants while conserving these species, which seems a difficult task ahead. In order to withstand competition in the global market, it is necessary to create a brand image, especially in cosmeceuticals and natural products. Herbal medicines are in great demand and are used by approximately 80% of the world’s population. Their popularity is due largely to their presumed safety, efficacy, cultural acceptability, and lesser side effects compared with prescription medications; perhaps most important, they are viewed as cost effective and accessible.

 

About 1200 licensed small manufactures in India are on record. The demand for herbal medicines is increasing and it is estimated that the production of herbal drug may be around Rs.4000 crores in the year 2010 AD. There are 1650 herbal formulation in Indian market and number of major plants involved in their formulation is 540. Medicinal plants have been a major source of cure of human diseases since time immemorial.

 

Regarding all the above facts it is very important to maintain the quality of Indian system of medicines so as to achieve attention of global market and to provide better health to human beings.

 

There was a need of such a book which can give a Ayurvedic graduate knowledge of whats going on in India and the world towards quality control of herbal medicine and apart from ancient techniques what are the other ways to develop and maintain the quality of medicine. This book is a compilation of the modern techniques and the latest systems followed in India as well as the whole World to apply quality control on the herbal medicines. The methods that are suggested by WHO and the national boards are discussed in detail in the book. This book is going to be very useful to all those ISM graduates and post graduates who want to have a broad and relevant knowledge of ayurveda and other Indian pathies. I hope that students interested in research will gain a lot from this book. This book is mainly written by keeping in mind the interests of M.D students.

 

Introduction

 

Quality of a product is a very hot topic nowadays, and especially in the pharmaceutical industry. The segment of herbal medicinal products is no exception. Indeed, the regulatory authorities have paid special attention to quality in this particular industry, due to the high risk of damage to life and health of patients possible, and developed many guidelines to insure a sufficient level of quality. Quality is not any more considered achieveable by strict adherence to, and verification of, specifications of measurable parameters but has to be generated by a systematically planned and guided process. Quality is not any more the sole responsibility of a central quality control department but requires the engaged participation of the entire work force. The prerequisite is, therefore, high competency and motivation of everybody involved, regularly enforced by continuing education, qualification through in house schooling etc.

 

A study done by Robert B. Saper, MD, MPH and others was published in JAMA,(the journal of the american medical assosiation) which was to determine the prevalence and concentration of heavy metals in Ayurvedic HMPs manufactured in South Asia and sold in Boston-area stores and to compare estimated daily metal ingestion with regulatory standards.The conclusion of that study was that One of 5 Ayurvedic HMPs produced in South Asia and available in Boston South Asian grocery stores contains potentially harmful levels of lead, mercury, and/or arsenic. Users of Ayurvedic medicine may be at risk for heavy metal toxicity, and testing of Ayurvedic HMPs for toxic heavy metals should be mandatory.

 

This study is sufficient enough to show that how much quality control is essential in ISM system so as to become competent in health services.

 

Plant materials are used throughout in developed and developing countries as home remedies, over-the-counter drug products and raw materials for the pharmaceutical industry, and represent a substantial proportion of the global drug market. It is therefore essential to establish internationally recognized guidelines for assessing their quality.

 

The World Health Assembly - in resolutions WHA31.33 (1978), WHA40.33 (1987) and WHA42.43 (1989) - has emphasized the need to ensure the quality of medicinal plant products by using modern control techniques and applying suitable standards.

 

Now people rely more on herbal drugs because of high prices and harmful side effects of synthetic drugs, and this trend is growing, not only in developing countries but in developed countries too. Unfortunately, the number of reports of people experiencing negative effects, caused by the use of herbal drugs, has also been increasing. There may be various reasons for such problems, like one of the major causes of adverse effects is directly linked to the poor quality of herbal medicines. In addition, thousands of vaidyas have their own miniature manufacturing facilities. Natural products have been used as source of drugs for centuries in many parts of the world. Screening of natural products is a very effective strategy for finding new chemical compounds, which may have medicinal use. The Department of Indian System of Medicine and Homeopathy has been specially dealing with the rules and regulations for the herbals along with the Drugs and Cosmetic Act and has come up with the rules for the implementation of good manufacturing practices in herbals, which will not only help to make quality herbal products but also safeguard the adverse effects of the herbals. With all these, India has to take up the challenge of leading the drug and herbal market while conserving its rich heritage through proper planning and implementation of policies. The past few years in particular have seen a major increase in the use of herbal products. Herbal medicinal products may have therapeutically beneficial effects, but a number of them cause adverse effects and drug interactions similar to conventional agents. The interaction potential of herbs with conventional drugs is an especially critical concern for drugs with narrow therapeutic indexes. Therefore, knowing the efficacy and safety of herbal drugs is crucial. In fact, one of the most serious hazards associated with herbal medicines is that many patients are under the illusion that because herbs are obtained from nature, they are completely safe and have no side effects. Thus, it is important that they be instructed to take proper precautions while using herbal medicines.

 

The decision to introduce Good manufacturing Practice (GMP) in the preparation of Ayurvedic medicines is to ensure the above quality of these formulations. If the industry follows GMP and ensure data based efficacy of their products, they will be widely accepted. World health organization (WHO) has also issued guidelines for issuing GMP certificate for the manufacturing of herbal medicinal products. Many countries require GMP certification, as per WHO parameters, before they buy any herb or herbal product.

 

In recent years, there has been great demand for plant derived products in developed countries. These products are increasingly being sought out as medicinal products, nutraceuticals and cosmetics. There are around 6000 herbal manufacturers in India. More than 4000 units are producing Ayurveda medicines. Due to lack of infrastructures, skilled manpower reliable methods and stringent regulatory laws most of these manufacturers produce their product on very tentative basis. In order to have a good coordination between the quality of raw materials, in process materials and the final products, it has become essential to develop reliable, specific and sensitive quality control methods using a combination of classical and modern instrumental method of analysis.

 

Safety Concerns - Adverse Reactions and Drug Interactions-Herbal medicines are generally considered comparably safer than synthetic drugs. While this may be probably correct, case reports show that severe side effects and relevant interactions with other drugs can occur. Lack of regulatory standards regarding the efficacy and safety of herbal products did not arouse much concern in the past, as these products were often perceived as so safe that even if they were ineffective, little harm resulted. However, the situation is changing now and there is an increasing body of literature on the side effects and interactions of herbal medicines. Besides the direct risks of adverse effects and drug interactions there is an indirect risk that an herbal remedy without demonstrated efficacy may compromise, delay, or replace an effective form of conventional treatment.

 

Current Status of Medicinal Plants

Total recorded plant species in world 2, 50,000

Plants used as MP in world 35,000

Total number of plants in India 47,000

Flowering plants in India 19,000

Plants used as MP in India 6,000

Plants Used in ISM 24,00

 

The ISM formulations need to be standardized and improved to satisfy the expectations of the modem day science.

 

The Need of the Hour

Evaluation policy on herbal formulations

Scientific documentation of efficacy and safety of drugs

Standardization of ISM formulations

Quality of herbal medicine

Proper Storage conditions

Minimizing batch to batch variation

Elimination of Adulteration& Substitution

 

The Need for Quality Evaluation on Herbal Drugs

Oral Knowledge - eroded / distorted because of - Persistent invasion - Cultural adaptation.

Lack of systematic documentation of standard procedure for maintaining the in- ventory of the knowledge of the medicinal plants

 

Following good evaluation practice in herbal medicine is an effective strateg

 

in achieving health for all. Good evaluation practice is the right evaluation at the right time, with the right investigators conducted with the highest ethical standards.

 

A strong commitment is required from the research community to follow good evaluation practice and to provide quality information about herbal medicine to the public and health professionals. Rigorous quality research is needed to support the claims of herbal medicine for the benefit of man kind. Today, this evaluation process is contributed from the collective technical expertise in several diverse areas, including ethnobotany and ethnopharmacology, classical botanical pharmacognosy, natural products chemistry, phytochemistry, analytical pharmacognosy, phytotherapy and clinical pharmacy.

 

Achieving complete and wholesome standardization of evaluation of herbal formulations is the need of the hour and its implementation will be a historic leap towards India’s health security.

 

Contents

 

Ch. 1

Introduction

1

Ch. 2

Definitions

5

Ch. 3

Quality control

11

 

Quality Control Measures

16

 

Quality Assurance

17

 

WHO Guidelines On GACP For Medicinal Plants (Good Agricultural and Collection Practices)

22

 

Good Agricultural Practices for Medicinal Plants (Prepared By- National Medicinal Plant Board, Dept. of AYUSH)

23

 

Guidelines On Good Field Collection Practices For Indian Medicinal Plants (Prepared By- National Medicinal Plant Board, Dept. Of AYUSH)

30

 

Pharmacovigilance of Herbal Medicinal Products

42

 

WHO guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems

42

 

National Pharmacovigilance Protocol For ASU Drugs

46

 

Govt. Steps for Quality Control on Ayurvedic Medicines

52

 

The Drugs and Cosmetics Act And Rules (Govt. Of India)

55

 

GMP for Ayurvedic, Siddha and Unani Medicines

71

 

Current Good Laboratory Practices (Guidelines For ISM & Homoeopathic Drug Testing Laboratories)

82

 

Good Storage Practices for Pharmaceuticals

92

 

Good Distribution Practices (GDP) for Pharmaceutical Products

98

Ch. 4

Standardization Of Herbal Medicine

110

 

Introduction

110

 

Protocols for Standardization of Herbal Drugs

113

 

WHO Guidelines for Herbal Drug Standardization

115

 

Who Guidelines for Monographs on Medicinal Plants

116

 

Quality Control Methods For Medicinal Plant Materials (As per WHO,Geneva)

119

 

Standards For Medicinal Plant Materials (As Per Ayurvedic Pharmacopoeia Of India)

121

 

(a) Identification of Crude Drugs

121

 

(b) Quantitative Determination of Crude Drugs

130

 

(c) Physical Tests and Determinations

166

 

(d) Chemical Tests and Assays

181

 

ASU Drug Development, Standardization & Quality Parameters

188

 

In - Process Standardization

197

 

Final Product Standardization

203

 

Evaluation of Safety And Efficacy of Herbal Medicines

231

 

Stability And Shelf Life of The Fimshed Product

235

 

Pharmacological Standardization

238

 

Guidelines for Toxicity / Safety Profile Evaluation of ASU Drugs

239

 

Guidelines for Toxicity Evaluation of Bhasma/Rasakalpas

249

 

Clinical Standardization

254

 

Good Clinical Practice Guidelines

254

 

Appendix-I

272

 

Appendix-If

277

 

References

282

 

Sample Pages


Item Code: NAI325 Author: Dr. Devendra Joshi and Dr. Geeta Joshi Cover: Hardcover Edition: 2011 Publisher: Chaukhambha Orientalia ISBN: 9788176372374 Language: English Size: 10 inch X 7 inch Pages: 296 Other Details: Weight of the Book: 680 gms
Price: $30.00
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