Quality Standards of Indian Medicinal Plants (Set of 17 Volumes)

Book Specification

Book Description

Volume 1

Edition: 2003

Foreword

It is being globally recognized that medicinal plants play a significant role in providing health benefits to human beings. The increase in the demand for plant based medicines and their eventual commercialization has brought about a major shift in their status from providing strictly individually tailored hand picked plant products based health care to availability of over the counter health products. But global acceptance of Indian plant-based drugs is still low. Non-availability and/or inadequacy of quality standards is perhaps the single most important factor responsible for it. International agencies like World Health Organization (WHO), United Nations Industrial Development Organisation (UNIDO), International Centre for Science and High Technology (ICS) and Asia Pacific Centre for Transfer Technology (APCTT) have also emphasized on the need of ensuring quality control of medicinal plant drugs by applying suitable standards employing modern techniques. But this is unlikely to be achieved until the quality of the base material for formulating the herbal products is assured. The complex composition of medicinal plant drugs, has posed a major challenge for quality control.

Standardization of the presumed active constituents of the drug is perhaps not the best approach; as only in few cases does the drug-activity depend upon a single component. In fact, it is the outcome of synergistic effect of several active compounds and accompanying inert substances. It is thus, reasonable to use the naturally occurring wholesome medicinal plant material for standardization. A number of factors such as age and origin of the plant, time of its collection, method of drying, garbling, storage etc. influence the proportion of various components in the plant material. The analytical limits therefore, cannot be expected to be as precise as for the single pure synthetic drug.

Inspite of these and other inherent difficulties, quality standards for the medicinal plants used in India are necessary for the drugs and formulations produced from them to be of adequate quality, safety and efficacy for their wide acceptance.

In response to this need, the Indian Council of Medical Research has taken the initiative to lay down quality standards of important medicinal plants, as per WHO guidelines. Reputed institutes have been involved to evolve these standards. Vital has resulted in the production of this volume, which is first in the series and deals with 32 medicinal plants. I trust this volume will be of immense help to medicinal plant based data generated at these institutes and compilation of the requisite information from literature drug industry, drug analytical laboratories, drugs control authorities, academicians and researchers engaged in work on medicinal plant drugs.

I deeply appreciate the efforts of the Chairman and the members of the various Committees viz., Scientific Advisory Group, the Task Force, the Technical Review Committee. The work would not have been possible but for the important role played by the collaborative Institutions.

Despite certain limitations that these standards may have, it is a step towards improving the quality of finished product. Better quality would inevitably help in raising the acceptance of Indian plant based health products.

Preface

Interest in medicinal plants has been overwhelming in the recent times especially as an important source of medication/health care in Indian Systems of Medicine. Currently, the global market for medicinal plants has been estimated around US $62 billion and the demand is growing rapidly. While, the domestic trade in herbal drug preparations used in Indian Systems of Medicine is to the tune of Rs. 4200 crores per annum, the annual export from India to the tune of Rs. 400 crores only.

In our country nearly 7,500 plant species are being used in the formulation of medicinal plant-based health care products. The quality and the efficacy of these preparations depend largely on the quality of the raw material used. The increase in the reported incidence of toxicity, indiscriminate use and easy availability of herbal preparations and food supplements makes it imperative to lay down standards which could ensure their quality, safety and efficacy. Our plant based drug industry too needs quality parameters for medicinal plants for the production of quality ensured standardized herbal drugs.

Evolving methods of standardization and establishing quality control parameters for herbal drugs calls for a well planned approach for establishing standards and this can be achieved only through systematic evaluation of the plant material using modern analytical techniques including chromatographic ones.

With this background, the ICMR took an initiative for development of standards of selected medicinal plants commonly used in India for their therapeutic value. A Task Force was constituted, list of plants drawn and the work was carried out at four institutions viz., B.Y. Patel Pharmaceutical Education and Research Development Centre, Ahmedabad; National Botanical Research Institute, Lucknow; National Institute of Pharmaceutical Education and Research, S.A.S. Nagar (Mohali) and Tropical Botanic Garden and Research Institute, Thiruvanthapuram. The work done at these institutes has resulted in preparation of monographs on 32 plants encompassing detailed pharmacognostic and phytochemical studies coupled with other information based on literature review.

The publication is the first volume in the series on standards of medicinal plants and is expected to be useful for the herbal drug industry/pharmacies, practitioners of indigenous systems of medicine, academicians, researchers and health professionals. The regulatory authorities may also find it useful as a reference. Preparation of the second volume in the series is in progress.

Introduction

Plant based medicines have been used by mankind since time immemorial. According to the report of World Health Organization, over 80 per cent of the world population relies on the traditional systems of medicine, largely plant based, to meet their primary health care. The effectiveness of these systems, in turn, mainly depends upon the proper use and sustained availability of genuine raw material. Global resurgence of the interest in herbal drugs has led to the need of their mass production which perhaps was not even contemplated by the traditional medicine practitioners who prepared and dispensed the medicine on a personal and individual basis. Largescale production of medicinal plant products necessitated the availability of standards to ensure their quality, efficacy and safety.

Furthermore, limited availability of medicinal plants of consistent quality has been perhaps one of the toughest impediment for reliable biological, pharmacological, chemical and clinical evaluation besides their use in health care. Lack or inadequacy of quality standards has been a discouraging factor for many potential herbal drug manufacturers and also a handicap in regulating the herbal drug market.

Against this backdrop, the Indian Council of Medical Research initiated a programme for laying down quality standards of about 200 medicinal plants widely used in India. Special emphasis has been laid on various chromatographic techniques including thin layer chromatographic, fingerprinting, HPTLC, HPLC, and GLC wherever needed. The studies complemented by literature backup has resulted in the preparation of monographs on 32 individual medicinal plants which have been covered in the present first volume. The work on the remaining plants is in progress.

The contents of monograph on each plant have been systematically described as follows:

Botanical name with authority, synonym, part(s) used, geographical source.

Other names of the drug in different languages.

Part(s) of the plant used as drug.

Macroscopic and microscopic description of the drug with special emphasis on diagnostic characters of the part(s) used along with colour photographs of the plant, part(s) used and illustrated diagrams of histological features.

Chemical constituents, structure of important chemical constituents. Identity test based on different chemical groups and TLC / GLC fingerprint profiles along with marker compound(s).

Assay/analytical method (using HPLC, HPTLC, GLC etc.) for the analysis of marker compounds along with detailed procedure and chromatograms.

Other quantitative standards include foreign matter, total ash, acid-insoluble ash, ethanol-soluble extractive, water-soluble extractive and loss on drying.

Adulterants/substitutes if any, giving details of distinguishing features from the genuine drug.

Important pharmacological and clinical studies in brief, as reported in the literature.

Therapeutic category as mentioned in Ayurvedic texts or as evidenced by clinical trials and reported in literature.

Safety aspects as mentioned in Ayurvedic texts or as reported in publications on pharmacological/toxicological aspects.

Dosage as mentioned in Ayurvedic texts or as reported in other scientific publications.

Complete references of the work cited.

This is followed by relevant appendices giving methods for evaluation of crude drugs (appendix I), phytochemical evaluation of raw material (appendix II), methods for isolation of markers (appendix III), drying and storage of raw material (appendix IV), pesticides, residues and microbial contamination (appendix V) and plant allocated to various institutions (appendix VI). Indices on botanical names, chemical constituents and other names of plants have been given at the end.

Volume 2

Edition: 2005

Foreword

There has been global resurgence’ of interest in the area of medicinal plant health care products, as a result of which, a number of national and international organizations such as World Health Organization, European Scientific Cooperative, German Commission E, Japanese and Chinese organizations, have taken initiative to prepare and publish monographs on medicinal plants. All such monographs lay special emphasis on quality standards of the plant material. India is one of the twelve mega biodiversity centres rich in medicinal and aromatic plants occurring in diverse ecosystems. Out of the 45,000 known plant species nearly 1500 plant species are being used in the Indian System of Medicine. In the draft of the National policy on the Indian System of Medicine, priority is being given to research on standardization besides pharmacology, toxicology and clinical trials of herbal drugs.

The Indian Council of Medical Research took initiative to lay down quality standards of important medicinal plants involving reputed research institutes. The collection of monographs published in 2003 as “Quality Standards of Indian Medicinal Plants Vol. 1” was the outcome of these efforts. The current publication is the second volume of the above series. We are happy to note that the first volume was greatly appreciated and received well by all those involved in different activities related to herbal drugs in India and abroad. I hope that just like the first volume, the second volume will also be of great help to medicinal plant based drug industry, drug regulatory authorities, researchers and academicians involved in work on medicinal plants.

I greatly appreciate the efforts of the Chairman and the members of the Scientific Advisory Group, Task Force and the Technical Review Committees and the contributions made by the participating institutions.

Preface

Worldwide interest in multifaceted potential of plants has resulted into gradual transition of the traditional medicine from being a personalized one to the present state where the plant based drugs are commercially produced in large scale and sold as OTC drugs or as prescription medicines. Furthermore in India where almost 90 percent of the raw material for herbal medicinal products is procured by the industry from wild sources, there is every possibility of vast variation of chemical constituents in the material collected from different geographical sources. In addition there is a possibility of deliberate adulteration or substitution in the genuine raw material. In such a scenario proper quality control of the herbal raw material as well as finished products becomes essential. Thus, the need for development of quality standards and preparation of monographs there on, cannot be over emphasized.

In an effort to address this problem, the Indian Council of Medical Research initiated a programme on evolving standards for the medicinal plants involving reputed research institutes in the country. Under this programme the first volume of “Quality Standards of Indian Medicinal Plants” covering 32 plants was published in 2003. This is the second volume in the series and contains quality standards of another set of 32 medicinal plants. As with the first volume, the second volume in the series is also expected to be well received and useful to the herbal drug industry, practitioners of Indigenous System of Medicine, academicians, researchers and health professionals including regulatory authorities.

Preparation of the third volume in the series is in progress.

Introduction

World Health Organization promotes and encourages the use of herbal medicinal products in the national health care programmes of various countries as 3/4th of the world population relies on traditional systems of medicine, largely medicinal plant based, to meet their primary health care needs. Lack of or inadequacy of quality standards of the herbal material has been an impediment in the wider acceptance of the herbal medicinal products as well as a discouraging factor for many reputed herbal drug manufacturers and also a handicap in regulating herbal drug market. In an effort to address this problem, the Indian Council of Medical Research initiated work on the preparation of standards for herbal raw material involving several reputed research institutes in the country. This endeavour resulted in publication of the first volume on “Quality Standards of Indian Medicinal Plants” in 2003. In continuing efforts in this direction, this is the second volume in the series containing monographs on the raw material from 32 medicinal plants. The approach being followed for executing this work is as follows:

Authentic plant material is procured from three geographical locations. Details of pharmacognostic features, quantitative standards and phytochemical profiles are generated by the participating institutions. Information on the distribution of the plants, vernacular names, chemical constituents, pharmacological activity, adulterants/substitutes, therapeutic claims, safety aspects and dosage is derived from the published literature and classical books. Literature search for each plant is made, reviewed and only the relevant information is incorporated from original articles.

From the information so generated, each monograph is compiled, and presented in a uniform format, under the following heads:

The monograph starts with the part used, botanical name with authority, synonyms and distribution of the plant.

Other Names: Include vernacular names of the drug (part of the plant that is being used) in different regions of the country.

Description: Contains macroscopy and microscopy of the drug with special emphasis on diagnostic characteristics, organoleptic examination of the raw material as well as its powder and illustrated figures and photographs are also given.

Chemical Constituents: The structures of important compounds and active principles (if known) are given. While making the structures of the chemical constituents, stereochemistry is also taken into consideration wherever information on stereochemistry of specific compounds is available. The chemical constituents are listed under two sub heads, viz., major and others. Under the former category, the chemical constituents which are either present in significant amount in the drug or are important from the activity point of view (active principle of the drug), even if present in relatively small amounts are given. Under the second category of chemical constituents which are present in small amount or their contribution towards the activity of the drug is not known, are listed.

Identity Tests: Chromatographic fingerprint profiles have been generated using thin layer chromatography, high performance liquid chromatography or gas liquid chromatography, as per the suitability. As far as possible, fingerprint profiles are given along with a marker compound.

Assay/Analytical Methods: Detailed description for the analysis of marker compound is given. In certain cases, chemical groups are estimated, e.g., total alkaloids, total hydroxyanthracene derivatives, etc. In all the cases, sample preparation is optimized to enable complete extraction of compounds of interest.

Quantitative Standards: Extractive values and ash values are derived by employing standard methodology and techniques as given in the Indian Pharmacopoeia or Ayurvedic Pharmacopoeia of India or WHO guidelines for Quality Standards of Medicinal Plants.

Adulterants/Substitutes: Information is provided whereever available and distinguishing features are cited with appropriate references.

Pharmacology: Includes important pharmacological activities of the part of the plant described as drug. The information is derived in majority of the cases from the original published articles in journals of repute. Clinical trials, wherever conducted have been mentioned.

Major Therapeutic Claims: These are derived from classical texts of Ayurveda with appropriate references and also other standard publications or evidenced by clinical trials reported in the literature.

Safety Aspects: Incorporates data available on the drug mentioned with appropriate references. If no specific toxicity is reported, it is considered to be safe in the dose traditionally used.

Dosage: Is taken from the standard Ayurvedic texts or from literature, if published.

The monograph is supported by colour photographs of the plant, the part of the plant used as drug, photomicrographs and/or camera lucida diagrams of the histology of the drug, and TLC finger print details and chromatograms, supported with complete references of the work cited.

Relevant appendices are added at the end of the volume, giving methods for the evaluation of the crude drugs (Appendix I), phytochemical evaluation of raw material (Appendix II), methods for isolation of markers (Appendix III), drying and storage of raw material (Appendix IV), pesticide residues and microbial contamination (Appendix V) and plants allocated to various institutes for development of quality standards (Appendix VI). Indices on botanical names, chemical constituents and names of plants in other languages have been given at the end.

Volume 3

Edition: 2005

Foreword

Man’s dependence on plants for health care is as old as the existence of the mankind on this planet. Since the advent of modern medicine, plants have also become a source of important phytopharmaceuticals and lead molecules with unique chemical structures and mechanism of action. Over the last few decades alternative medicine, which is essentially plant based, has experienced a remarkable and steady increase all over the world. This has generated a multifaceted interest in the medicinal plants, which includes the sourcing of the raw material (through cultivation or from wild populations), preparation of formulations, multimarker based phytochemical evaluation for standardization, pharmacological, toxicological and clinical evaluation to establish efficacy and safety, of single drugs as well as polyherbal formulations and their large scale manufacture and marketing. This activity has necessitated the requirement of good quality of raw material. Consequently it became important to establish quality parameters for the herbal raw material. In the recent years many national and international bodies have been preparing and publishing monographs on medicinal plants defining quality parameters necessary to maintain quality.

In India, with its age old traditional systems of medicine and rich treasure of medicinal plants, about 1500 plant species are being used in the Indian System of Medicine, and many more plants in the folk and tribal medicine. The Indian Council of Medical Research took initiative to lay down standards for herbal raw material from important medicinal plants, involving reputed research institutes of India. An outcome of these efforts has been the publication of two volumes of monographs on the “Quality Standards of Indian Medicinal Plants”. The current publication is the third volume of this series. The first two volumes received the appreciation of all those involved in different activities related to medicinal plants, We hope that the third volume also will be received well and be of help to herbal drug industry, drug regulatory authorities, researchers and academicians. I greatly appreciate the efforts of the Chairman and members of the Scientific Advisory Group, the Task Force, the Technical Review Committee, investigators and the research institutions which contributed to the significant task of developing quality standards.

Preface

The interest in and the demand for the plant based drugs increased in the last few decades, and this led to large scale commercial production of both classical and proprietary herbal formulations in the country. As a result, the demand for herbal raw material also increased. The raw material is being procured from wild as well as cultivated sources. Several factors are known to influence the quality of the herbal raw material. Hence, to maintain quality and to ensure efficacy, quality parameters are to be defined.

Sensing this need, the Indian Council of Medical Research initiated a programme to develop monographs on important Indian medicinal plants involving several research institutes and laboratories of the country. The monographs so evolved are being published under a series. So far two volumes of “Quality Standards of Indian Medicinal Plants” have been published which contain monographs on 32 medicinal plants each. This is the third volume in the series with monographs on 40 medicinal plants. We expect these monographs to be of use to the herbal drugs manufacturers, regulatory authorities, academicians, researchers and those interested in medicinal plants.

Work on preparing monographs on raw materials from many more medicinal plants is in progress.

Introduction

Multifaceted potential of medicinal plants, as also the fact that about three fourth of the world population relies on traditional systems of medicine to meet their primary health care needs, has generated a global interest in the area of medicinal plants. Various international agencies like World Health Organization have been emphasizing on the importance and need of standardization of herbal raw material. Lack of or an inadequate quality standard of raw material has been one of the major impediments in wider acceptance of herbal drugs. It has also been a discouraging factor for many herbal drug manufacturers besides being a handicap in regulating herbal drug market. In an effort to address this problem, the Indian Council of Medical Research initiated work on the preparation of standards for herbal raw material involving several reputed research institutes in the country. This endeavour resulted in publication of the two volumes on “Quality Standards of Medicinal Plants”. In continuing efforts in this direction, this is the third volume in the series containing monographs on the raw material from 40 medicinal plants. The approach being followed for executing this work is as follows:

Authentic plant material is procured from three geographical locations. Details of pharmacognostic features, quantitative standards and phytochemical profiles are generated by the participating institutions. Information on the distribution of the plants, vernacular names, chemical constituents, pharmacological activity adulterants/substitutes, therapeutic claims, safety aspects and dosage is derived from the published literature and classical books. Literature search for each plant is made, reviewed and only the relevant information is incorporated from original articles.

From the information so generated, each monograph is compiled, and presented in a uniform format, under the following heads:

The monograph starts with the part used, botanical name with authority, synonyms, geographical source and distribution of the plant.

Other Names: Include vernacular names of the drug in different regions of the country.

Description: Contains macroscopy and microscopy of the drug with special emphasis on diagnostic characteristics, organoleptic examination of the raw material as well as its powder. Illustrated figures and photographs are also given.

Chemical Constituents: The chemical constituents are listed under two sub heads, viz.; major and others. Under the former category, the chemical constituents which are either present in significant amount in the drug or are important from the activity point of view (active principle of the drug), even if present in relatively small amounts are given. Under the second category, the chemical constituents which are either present in small amount or their contribution towards the activity of the drug is not known, are listed. The structures of important compounds and active principles (if known) are given. While making the structures of the chemical constituents, stereochemistry is also taken into consideration wherever information 0 specific compounds is available.

Identity Tests: Chromatographic fingerprint profiles have been generated using thin layer chromatography, high performance liquid chromatography or gas liquid chromatography, as per the suitability. TLC is found to be practically more feasible and suitable to resolve most of the components of the extract under study. As far as possible, fingerprint profiles are given along with a marker compound.

Assay/Analytical Methods: Detailed description for the analysis of marker compound is given. In certain cases, chemical groups are estimated, e.g., total alkaloids, etc. In all the cases, sample preparation is optimized to enable complete extraction of compounds of interest.

Quantitative Standards: Extractive values and ash values are derived by employing standard methodology and techniques as given in the Indian Pharmacopoeia or Ayurvedic Pharmacopoeia of India or WHO guidelines for Quality Standards of Medicinal Plants.

Adulterants/Substitutes: Information is provided where ever available and distinguishing features are cited with appropriate references.

Pharmacology: Includes important pharmacological activities of the part of the plant described as drug. The information is derived in majority of the cases from the original published articles in journals of repute. Clinical trials, wherever conducted have been mentioned.

Major Therapeutic Claims: These are derived from classical texts of Ayurveda with appropriate references and also other standard publications or evidenced by clinical trials reported in the literature.

Safety Aspects: Incorporates data available on the drug mentioned with appropriate references. If no specific toxicity is reported, it is considered to be safe in the dose traditionally used.

Dosage: Is taken from the standard Ayurvedic texts or from literature, if published.

The monograph is supported by colour photographs of the plant, the part of the plant used as drug, photomicrographs and/or camera lucida diagrams of the sections of the drug, and TLC finger print details and chromatograms, supported with complete references of the work cited.

Relevant appendices are added at the end of the volume, giving methods for the evaluation of the crude drugs (Appendix I), phytochemical evaluation of raw material (Appendix II), methods for the isolation of markers (Appendix III), drying and storage of raw material (Appendix IV), pesticide residues and microbial contamination (Appendix V) and plants allocated to various institutes for development of quality standards (Appendix VI). Indices on botanical names, chemical constituents and other names of the plants have been given at the end.

Volume 4

Edition:2006

Foreword

The growing worldwide interest in medicinal plants and fast expanding global market in the last two decades, has necessitated for quality ensured herbal drugs. Further, the increase in the incidence of toxicity reported due to the indiscriminate use of herbal preparations available over the counter and as food supplements make it important to ensure their safety and efficacy. Therefore, in the present business and industrial scenario, and con