Edition: 2003
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.
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.
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.
Edition: 2005
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.
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.
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.
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.
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.
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.
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.
Adulterants/Substitutes: Information is provided where ever available and distinguishing features are cited with appropriate references.
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.
Edition:2006
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 considering the interest and faith that people have on herbal products, the need for their standardization cannot be over emphasized. The safety and efficacy of herbal preparations depend largely on the quality of the raw material used.
In this backdrop, ICMR took initiative in evolving quality standards for plants most widely used as raw material in Indian systems of medicine, especially those of Ayurveda. Several reputed institutions are involved in this endeavour. The efforts have so far resulted in bringing out three volumes of Quality Standards of Indian Medicinal Plants carrying monographs on 104 plants. The current publication with Monographs on 32 plants is fourth in the series. I do hope the present volume shall also be received well with all those concerned with medicinal plants. The commendable efforts and co-operation of the Chairman and the members of Scientific Advisory Group, the Task Force, the Technical Review Committee as also the investigators and the research institutions in bringing out this publication are appreciable.
Medicinal plants constitute one of the richest bioresource for herbal drugs, food supplements, natural cosmetics, complimentary alternate medicines, phytoconstituents of industrial significance and lead molecules for the development of Allopathic drugs. A number of countries including Germany, France, Canada, USA, China, etc. are registering standardized medicinal plant extracts of proven clinical efficacy and safety as herbal drug preparations or food supplements. Inspite of the fact that India has a vast resource of medicinal plants, we are unable to exploit the growing world market to the required extent because we do not have a very satisfactory system of their quality control and registration. Therefore, it becomes absolutely essential to have quality standards of the raw material.
In this direction, in the year 2000 the ICMR initiated work on quality standards of Indian medicinal plants, involving laboratories of reputed institutes of the country. Three volumes of "Quality Standards of Indian Medicinal Plants" covering standards of 104 medicinal plants have already been published. We expect that this fourth volume like the earlier three volumes will also be of interest to the herbal drug industry, practitioners of the Indigenous Systems of Medicine, academicians, researchers, health professionals and regulatory authorities.
In the National Policy on the Indian Systems of Medicine (ISM) by the Department of A YUSH, priority is being given to research on standardization, pharmacology, toxicology and clinical trails of ISM drugs. In all these studies one important common factor, which can be called the lifeline, is the quality, especially of the raw material, and the crux is the inavailability of methods for the quality assessment.
Currently, the herbal drug preparation itself is regarded as the active substance. Hence the reproducibility of the total configuration of herbal drug constituents is important, and the TLC/GLC/ HPLC fingerprint profiles will serve as guiding line to the phytochemical profile of the drug in ensuring the quality, while quantification of the marker compound/s would serve as an additional parameter in assessing the quality of the sample.
As a part of its ongoing programs, Medicinal Plants Unit of the Indian Council of Medical Research has been bringing out a series of publications on the quality standards of important medicinal plants used in the traditional medicine. This is the fourth volume in the series, "Quality Standards of Indian Medicinal Plants" containing 32 monographs. Several national institutions have been participating in this national endeavour and just as in the first three volumes, the following guidelines have been adopted in evolving the standards for the plants included in this volume.
The raw material of the plants is procured from the field, from at least three different geographical locations and authenticated. The samples are worked out for their pharmacognostic and phytochemical features through experiments while the information on the distribution of the plants, vernacular names, chemical constituents, pharmacological activity, safety aspects, clinical studies if any, therapeutic claims and any other details are derived from the published literature and compiled in the form of a monograph, along with complete references of the work cited. The results of experiments conducted and the compiled data are subjected to careful scrutiny by the experts of the Technical Review Committee.
The monographs are compiled and presented in a uniform format as described below:
The monograph starts with the part used, botanical name with authority, synonyms, habit and distribution of the plant.
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. As far as possible the chemical constituents are grouped together on the basis of clan of compounds. 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.
Assay/Analytical Methods: Detailed description for the analysis of marker compound is given. In certain cases, chemical groups are estimated. In all the cases, sample preparation is optimized to enable complete extraction of compounds of interest.
Adulterants/Substitutes: Information is provided wherever 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 research articles published in journals of repute. Clinical trials, wherever conducted have been mentioned.
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 fingerprint details and chromatograms, supported with complete references of the work cited.
In the initial pages of the book abbreviations used are listed, and the plants included in the first three volumes are also listed for ready reference. Towards the end of the volume, relevant appendices are included, carrying details of the methods for pharmacognostic evaluation of the raw material which includes macroscopic, microscopic studies and the quantitative standards (Appendix T), phytochemical evaluation (Appendix II), methods for the isolation of markers (Appendix Ill), methods of drying and storage of raw material (Appendix IV), limits of pesticide residues and microbial contamination (Appendix V) and plants allocated to various institutes for preparing the monographs (Appendix VI). The appendices section is followed by indices on the botanical names, chemical constituents and names of plants in other languages.
Edition:2008
Resurgence of interest in the medicinal plants and their products all over the globe is evident from the rising figures of trade and marketing as well as extensive and intensive scientific publications in the national and international journals. In such a rising global market trend and scientific awareness of medicinal plant products, there exist many fold opportunities in various segments such as traditional medicines, home remedies, nutraceuticals, phytopharmaceuticals, natural drug molecules, gums, mucilages, natural dyes, insect repellants, insecticides, pesticides etc. There are a number of challenges in sustainable industrial exploitation of medicinal plants bioresource for all the segments mentioned. One of the major challenges is inadequacy of quality standards available for producing and maintaining quality and consistency of medicinal plant products. The Indian Council of Medical Research initiated the programme of developing quality standards of Indian medicinal plants in the year 2002. This endeavour yielded very fruit results evidenced by the publication of four volumes of Quality Standards of 136 medicinal plant. Under this continuing programme, this fifth volume comprising quality standards of another 34 Indian medicinal plants is being published. It's a commendable national effort at the appropriate time in the right direction. These quality standards will be of great help to all those engaged in developing various quality products from Indian medicinal plants.
The medicinal plants have not only been known to be the backbone of all systems of medicine but have been finding extensive place in household remedies, nutraceuticals and cosmetics. In view of the wider acceptance of medicinal plant based products and fast expanding market globally, the quality of the raw material used particularly in the herbal drugs assume special significance in context of experimental studies, clinical trials and therapeutics. Further, the TLC/GLCIHPLC fingerprint profile, as also quantification of the marker compound serve as guiding line to the phytochemical profile of the drug in ensuring the quality.
Medicinal Plants Unit of the Indian Council of Medical Research has been instrumental in developing quality standards of medicinal plants through participation of various reputed institutions, and bringing out a series of publication entitled "Quality Standards of Indian Medicinal Plants". The present volume is 5th in this series and contain monographs on 34 plants.
The following major guidelines have been adopted in evolving the standards and preparation of the monographs.
The raw material of the plants is procured from the field, from at least three geographical locations and authenticated. The samples are worked out for their pharmacognostic and phytochemical features through experiments while the information on the distribution of the plants, vernacular names, chemical constituents, pharmacological activity, safety aspects, clinical studies if any, therapeutic claims and any other details are derived from the published literature and compiled in the form of a monograph, along with complete references of the work cited. The experiments conducted and the compiled data is subjected to careful scrutiny by the experts of the scientific committee. The information incorporated in the monographs is further supported by the photographs of the plant, the part/s of the plant used, microscopic details, the TLC details, chromatograms, etc.
Each monograph starts with the part(s) used, botanical name with authority, synonyms, habit and distribution of the plant.
Chemical Constituents: Are given with the structures of important compounds and active principles (if known). 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. Under the second category of other chemical constituents which are in small amount or their contribution towards the activity of the drug is not known, are listed.
Identity Tests: Chromatographic fingerprint profiles which have been generated using thin layer chromatography, high performance liquid chromatography or gas liquid chromatography, as per the suitability. TLC is found to be more practically 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: Are described in detail for the analysis of marker compound. In certain cases, chemical groups are estimated. In all the cases, sample preparation is optimized to enable complete extraction of compounds of interest.
Quantitative Standards: With respect to 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: Are given wherever information is available and distinguishing features are cited with appropriate references.
Major Therapeutic Claims: 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 is 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.
In the initial pages of the book abbreviations used are listed, and the plants included in the first four volumes are also listed for ready reference. Towards the end of the volume, relevant appendices are included, carrying details of the methods for pharmacognostic evaluation of the raw material which includes macroscopic, microscopic studies and the quantitative standards (Appendix I), phytochemical evaluation (Appendix II), methods for the isolation of markers (Appendix III), methods of drying and storage of raw material (Appendix IV), limits of pesticide residues and microbial contamination (Appendix V) and plants allocated to various institutes for preparing the monographs (Appendix VI). The appendices section is followed by indices on the botanical names, chemical constituents and names of plants in other languages.
Edition: 2008
There has been global emphasis on the importance of standardization of herbal drugs particularly for delivering improved health care. The need for standardization has been recognized time and again world over at different global forums by various national and international agencies including WHO. Inadequacy or lack of standardization of raw material has been one of the most constraining factors in our ability to exploit the fast growing world market of herbal drugs to the required extent, despite India being credited with unique heritage of abundant biodiversity. These plant based drugs would be much more widely used nationally and internationally, with wider acceptance, for enhanced health care if the standardization provides creditability to the quality of the medicine used, In the time to come, only those countries with well established standards of herbal drugs can hope to exploit the worldwide growth in the use of herbal products.
It becomes imperative, therefore to have quality standards of the raw material used in various plant based products.
The Council's initiative to develop Quality Standards of Indian medicinal plants with major focus on diagnostic features, chromatographic profile, markers and overview of multidisciplinary information/data, shall be of importance and relevance for the herbal drug industry, researchers, health professionals, regulatory authorities, policy makers and others interested in the area of medicinal plants, The initiative may eventually help in development of quality assured safe herbal drugs for health care.
The medicinal plants have not only been known to be the backbone of all systems of medicine but have been finding extensive place in household remedies, nutraceuticals and cosmetics. In view of the wider acceptance of medicinal plant based products and fast expanding market globally, the quality of the raw materials used in the herbal drugs assumes special significance particularly in context of conducting experimental studies, clinical trials and their therapeutic value.
In this backdrop, the Medicinal Plants Unit of ICMR took initiatives in the year 2000 for developing Quality Standards of medicinal plants for more widely used raw materials. Several reputed institutions were involved.
The monographs are on the pattern of WHO guidelines and incorporate the diagnostic features, phytochemical studies including marker compound, information on pharmacological, clinical, toxicological aspects, dosage, adulterants/substitutes etc. The fingerprint profile (TLC/GLCIHPLC), as also quantification of the marker compound may serve as guiding line to the phytochemical profile of the drug in ensuring the quality.
As part of this initiative, 5 volumes incorporating Quality Standards of 170 medicinal plants have been published. The present volume is 6th in this series and contains quality standards of another 35 plants. These monographs are outcome of the ICMR programme carried out at Agharkar Research Institute, Pune; BV Patel Pharmaceutical Education and Research Development Centre, Ahmedabad; Captain Srini vasa Murti Drug Research Institute for Ayurveda, Chennai; Centre for Medicinal Plants Research, Arya Vaidya Sala, Kottakkal and National Botanical Research Institute, Lucknow.
It is hoped that the current volume like the previous volumes shall be useful to all those concerned with medicinal plants and their products.
Lack of quality standards of the raw material has been one of the major lacuna in the wider acceptance of plant based drugs. Medicinal Plants Unit of the Indian Council of Medical Research has initiated a programme for the preparation of quality standards for herbal raw materials involving several research institutes of Country to address this problem. This programme has resulted in publication of five volumes on "Quality Standards of Indian Medicinal Plants" covering 170 plants. The present volume is 6th in this series and contains monographs on 35 plants.
Each monograph starts with the part/s used, botanical name with authority, synonyms, habit and distribution of the plant.
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.
Identity Tests: Chromatographic fingerprint profiles which have been generated using thin layer chromatography, high performance liquid chromatography or gas liquid chromatography, as per the suitability are given. TLC is found to be more practically 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.
Dose: 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.
In the initial pages of the book abbreviations used are listed, and the plants included in the first five volumes are also listed for ready reference. Towards the end of the volume, relevant appendices are included, carrying details of the methods for pharmacognostic evaluation of the raw material which includes macroscopic, microscopic studies and the quantitative standards (Appendix I), phytochemical evaluation (Appendix II), methods for the isolation of markers (Appendix ill), methods of drying and storage of raw material (Appendix IV), limits of pesticide residues and microbial contamination (Appendix V) and plants allocated to various institutes for preparing the monographs (Appendix VI). The appendices section is followed by indices on the botanical names, chemical constituents and names of plants in other languages.
In recent years, the worldwide interest in herbal products has grown significantly particularly for delivering improved health care. With an increasing global demand for herbal medicines, it is necessary that the quality and the consistency of these drugs is maintained for their maximal efficacy. Inadequacy or lack of standardization of raw materials has been one of the most constraining factors in our ability to exploit the fast growing world market of herbal drugs to the required extent, despite India being credited with unique heritage of abundant biodiversity. These plant based drugs would be much more widely used both nationally and internationally, with wider acceptance, for enhanced health care if the standardization provides creditability to the quality of the medicine used.
The council's initiative to develop Quality Standards of Indian Medicinal Plants with major focus on diagnostic features, chromatographic profiles, markers and overview of multidisciplinary information/data, shall be of importance and relevance for the herbal drug industry, researchers, health professionals, regulatory authorities, policy makers and others interested in the area of medicinal plants. The initiative may eventually help in development of quality assured safe herbal drugs for health care.
I deeply appreciate the efforts of the Chairman, the members of the Scientific Advisory Group, the Task Force, the Technical Review Committee, investigators and the research institutes who have contributed to the significant task of developing quality standards.
The medicinal plants have not only been known to be the backbone of all systems of medicine but have been finding extensive place in household remedies, nutraceuticals, phytochemicals, natural drug molecules, gums, mucilages, natural dyes, insecticides, pescticides and cosmetics. In view of the wider acceptance of medicinal plant based products and fast expanding market globally, the quality of the raw materials used in the herbal drugs assumes special significance particularly in context of conducting experimental studies, clinical trials and their respective therapeutic value.
In this backdrop, the Medicinal Plants Unit of ICMR took initiatives for developing Quality Standards of Medicinal Plants for more widely used raw materials. Several reputed institutions were involved.
The monographs are on the pattern of WHO guidelines and incorporate the diagnostic features, phytochemical studies including marker compound, information on pharmacological, clinical, toxicological aspects, dosage, adulterants/substitutes etc. The fingerprint profile (TLC/GLC/HPLC), as also quantification of the marker compound may serve as guiding line to the phytochemical profile of the ensuring the quality.
As part of this initiative, 6 volumes incorporating Quality Standards of 205 medicinal plant have been published. The present volume is T" in this series and contains quality standards of another 34 plant . These monographs are outcome of the ICMR programme carried out at Agharkar Research Institute, Pune; BV Patel Pharmaceutical Education and Research Development Centre, Ahemdabad; Captain Srinivas Murti Drug Research Institute for Ayurveda, Chennai; Centre for Medicinal Plants Research, Arya Vaidya Sala, Kottakkal and National Botanical Research Institute, Lucknow.
We hope that the current volume like the earlier six volumes shall be useful to all those concerned with medicinal plants and their products.
Lack of quality standards of the raw material has been one of the major lacuna in the wider acceptance of plant based drugs. Medicinal Plants Unit of the Indian Council of Medical Research has initiated a programme for the preparation of quality standards for herbal raw' materials involving several research institutes of the country to address this problem. This programme has resulted in publication of six volumes on "Quality Standards of Indian Medicinal Plants" covering 205 plants. The present volume is T" in this series and contains monographs on 34 plants.
Chemical Constituents: Are given with the structures of important compounds and active principles (if known). 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, the chemical constituents which are either present in small amount or their contribution towards the activity of the drug is not known, are listed.
Identity Tests: Chromatographic fingerprint profile which have been generated using thin layer chromatography, high performance liquid chromatography or gas liquid chromatography, as per the suitability are given. TLC i found to be more practically feasible and suitable to resolve mo t of the components of the extract under study. A far as possible, fingerprint profiles are given along with a marker compound.
Adulterants/Substitutes: Are given wherever information is available and distinguishing feature is cited with appropriate references.
Safety Aspects: Incorporates data available on the drug along with appropriate references. If no specific toxicity is reported, it is considered to be safe in the dose traditionally used.
Dose: Is taken from the classical 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 fingerprint details and chromatograms, supported with complete references of the work cited.
In the initial pages of the book abbreviations used are listed, and the plants included in the first ix volumes are also listed for ready reference. Towards the end of the volume, relevant appendices are included, carrying details of the methods for pharmacognostic evaluation of the raw material which includes macroscopic, microscopic studies and the quantitative standards (Appendix I), phytochemical evaluation (Appendix 11), methods for the isolation of markers (Appendix 11I), methods of drying and storage of raw material (Appendix IV), limits of pesticide residues and microbial contamination (Appendix V) and plants allocated to various institutes for preparing the monographs (Appendix VI). The appendices section is followed by indices on the botanical names, chemical constituents and names of plants in other languages.
Edition: 2010
Medicinal plants play a significant role both in the developed and developing countries in providing health benefits to human beings. 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 raw material (through cultivation or from wild populations), preparation of formulations, multi marker based phytochemical evaluation for standardization, molecular target/cell/enzyme based assays, 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. In such a scenario proper quality control of the herbal raw as well as the finished products becomes essential. 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.
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 data generated at these institutes and compilation of the requisite information from literature has resulted in the production of this volume, which is the eighth in the series and deals with 35 medicinal plants.
I deeply appreciate the efforts of the Chairman and the members of the various committees viz., Scientific Advisory Group, the Task Force and 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 products. Better quality would inevitably help in raising the acceptance of Indian plant based health care products. These quality standards will be of great help to all those engaged in developing various quality products from Indian medicinal plants.
In India almost 90 per cent 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.
In an effort to address this problem, the ICMR initiated work on Quality Standards of Indian Medicinal Plants, involving laboratories of reputed institutes of the country to generate requisite data as per prescribed format for preparing monographs.
Each monograph is titled with botanical nomenclature and incorporates diagnostic macro and microscopic features, phytochemical constituents, identification by chromatographic fingerprints (TLC/GLC/HPLC), quantitative determination of the phytochemical marker using marker compound, information on pharmacological, clinical, toxicological aspects, dose, adulterants/substitutes etc.
The present 8th volume in the series of already published 7 volumes contains quality standards of 35 plants. The present Monographs are outcome of the ICMR programme carried out at Agharkar Research Institute, Pune; B. V. Patel Pharmaceutical Education & Research Development Centre, Ahmedabad; Captain Srinivasa Murti Drug Research Institute for Ayurveda, Chennai; Centre for Medicinal Plants Research, Arya Vaidya Sala, Kottakkal; National Botanical Research Institute, Lucknow; School of Natural Product Studies, Jadavpur University, Kolkata; University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh.
It is hoped that the current volume like the previous volumes will also be of interest to the herbal drug industry, practitioners of the Indigenous Systems of Medicine, academicians, researchers, health professionals and regulatory authorities.
Lack of quality standards of the raw material has been one of the major lacuna in the wider acceptance of plant based drugs. Medicinal Plants Unit of the Indian Council of Medical Research has initiated a programme for the preparation of quality standards for herbal raw materials involving several research institutes of country to address this problem. This programme has resulted in publication of seven volumes on "Quality Standards of Indian Medicinal Plants" covering 239 plants. The present volume is 8th in this series and contains monographs on 35 plants.
Each monograph starts with the parte(s) used, botanical name with authority, synonyms, habit 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.
Chemical Constituents: Are given with the structures of important compounds and active principles (if known). 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. 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.
Pharmacology: Includes important pharmacological, clinical and other biological 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.
Dose: Is taken from the Classical Ayurvedic texts or from literature, if published.
In the initial pages of the book abbreviations used are listed, and the plants included in the first seven volumes are also listed for ready reference. Towards the end of the volume, relevant appendices are included, carrying details of the methods for pharmacognostic evaluation of the raw material which includes macroscopic, microscopic studies and the quantitative standards (Appendix I), phytochemical evaluation (Appendix II), methods for the isolation of markers (Appendix III), methods of drying and storage of raw material (Appendix IV), limits of pesticide residues and microbial contamination (Appendix V) and plants allocated to various institutes for preparing the monographs (Appendix VI). The appendices section is followed by indices on the botanical names, chemical constituents and names of plants in other languages.
Edition: 2011
One of the stumbling blocks in the popularity and wider acceptance of herbal drugs is the inadequacy or lack of standards. This is primarily attributed to the raw material which is not of desired quality, as required for reliable biological, pharmacological and clinical evaluation besides their use in health. Therefore, it is imperative to ensure proper safety and adequate standards along with accurate information available to those who wish to conduct research and commercialize the product outcome in this area of life science.
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 data generated at these institutes and compilation of the requisite information from literature has resulted in the production of this volume, which is ninth in the series and deals with 35 medicinal plants.
I deeply appreciate the efforts of the chairman and the members of the various committees viz., Scientific Advisory Group, the Task Force and the Technical Review Committee as also the important role played by the investigators and the collaborative Research Institutions in bringing out this publication.
The plant based drug industry, drug testing laboratories, academicians, researchers, health professionals and regulatory authorities will find this book useful. Despite certain limitations, that these standards may have, it is a step towards improving the quality of finished products.
In India where 90 per cent 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 of the genuine raw material. In such a scenario proper quality control of the herbal raw material and finished products become essential. Thus, the need for development of quality standards and preparation of monographs thereof cannot be over emphasized.
In an effort to address this problem, ICMR initiated work on Quality Standards of Indian Medicinal plant, involving laboratories of reputed institutes of the country to generate requisite data as per prescribed format for preparing monographs.
Each monograph is titled with botanical nomenclature and incorporates diagnostic macro and microscopic features, phytochemical constituents, identification by chromatographic fingerprints (TLC/GLCIHPLC), quantitative determination of the phytochemical marker using marker compound and information on pharmacological, clinical, toxicological as well as parts used, dose, adulterants/ substitutes etc.
The present 9th volume in the series of already published 8 volumes contains quality standards of 35 plants. The monographs are outcome of the ICMR programme carried out at B.V. Patel Pharmaceutical Education and Research Development Centre, Ahmedabad, Gujarat; Captain Sriniva a Murti Drug Research Institute for Ayurveda, Chennai, Tamil Nadu; Centre for Medicinal Plants Research, Arya Vaidya Sala, Kottakkal, Kerala and L. M. College of Pharmacy, Ahmedabad, Gujarat.
Better quality would inevitably help in raising the acceptance of Indian plant based health care products. It is hoped that the current volume like the previous volumes will be of interest to those engaged in developing various quality products from Indian Medicinal Plants.
Preparation of the tenth volume in the series is in progress.
Lack of quality standards of the raw material has been one of the major lacuna in the wider acceptance of plant based drugs. Medicinal Plants Unit of the Indian Council of Medical Research has initiated a programme for the preparation of quality standards for herbal raw materials involving several research institutes of country to address this problem. This programme has resulted in publication of eight volumes on "Quality Standards of Indian Medicinal Plants" covering 274 plants. The present volume is 9th in this series and contains monographs on 35 plants.
The raw material of the plants is procured from the field, from at least three geographical locations and authenticated. The samples are worked out for their pharmacognostic and phytochemical features through experiments while the information on the distribution ofthe plants, vernacular names, chemical constituents, pharmacological activity, safety aspects, clinical studies if any, therapeutic claims and any other details are derived from the published literature and compiled in the form of a monograph, along with complete references of the work cited. The experiments conducted and the compiled data is subjected to careful scrutiny by the experts of the scientific committee. The information incorporated in the monographs is further supported by the photographs of the plant, the part/s of the plant used, microscopic details, the TLC details, chromatograms, etc.
In the initial pages of the book abbreviations used are listed, and the plants included in the first eight volumes are also listed for ready reference. Towards the end of the volume, relevant appendices are included, carrying details of the methods for pharmacognostic evaluation of the raw material which includes macroscopic, microscopic studies and the quantitative standards (Appendix I), phytochemical evaluation (Appendix II), methods for the isolation of markers (Appendix III), methods of drying and storage of raw material (Appendix IV), limits of pesticide residues and microbial contamination (Appendix V) and plants allocated to various institutes for preparing the monographs (Appendix VI). The appendices section is followed by indices on the botanical names, chemical constituents and names of plants in other languages.
Edition: 2012
The global interest in Medicinal Plants and the fast expanding world market during the last two decades have necessitated quality ensured herbal drugs. An increase in the incidence of toxicity reported due to indiscriminate use, deliberate or undeliberate adulteration/substitution and presence of contaminants in herbal preparations available over the counter and as food supplements make it important to ensure their quality, safety and efficacy. Quality standards of the Indian Medicinal Plants are necessary for the drugs and formulations produced from them to be of adequate quality, safety and efficacy for their wider acceptance and patients interest.
In response to this need, the Indian Council of Medical Research took initiative in the year 2001 to lay down quality standards of important Medicinal Plants as per WHO guidelines. The endeavour yielded very fruitful results evidenced by the publication of 9 volumes of Quality Standards of Indian Medicinal Plants containing 309 monographs. Under this continuing programme, this tenth volume on Quality Standards of another 35 Indian Medicinal Plants is being published.
Despite certain limitations that these standards may have, it is a step towards improving the quality of finished products. Better quality would inevitably help in raising the acceptance of Indian plant based health care products. These quality standards will be of great help to all those engaged in developing various quality products from Indian Medicinal Plants.
I deeply appreciate the efforts of the chairman and the members of the various committees, viz., Scientific Advisory Group, the Task Force and the Technical Review Committee as also the important role played by the investigators and the collaborative Research Institutions who have contributed to the significant task of developing quality standards.
Medicinal plants remain the main source of medicines for a large proportion of global population particularly in the developing world. In India the raw material for herbal medicinal products is mostly procured from wild sources, there is every possibility of vast variation of chemical constituents in the material collected from different geographical sources. There is also a possibility of deliberate adulteration and substitution in the genuine raw material. In such a scenario the proper quality control of the herbal raw material as well as the finished products become essential. Moreover, the quality of raw materials used in the herbal drugs assumes special significance particularly in context of conducting experimental studies, clinical trials and their therapeutic value.
The Medicinal Plants Unit of the Indian Council of Medical Research took initiatives for developing Quality Standards of Medicinal Plants for more widely used raw materials involving laboratories of reputed institutes in the country to generate requisite data as per prescribed format for preparing monographs. Each monograph is titled with botanical nomenclature and incorporates diagnostic macro- and microscopic features, phytochemical constitutents, identification by chromatographic fingerprints (TLCIGLCIHPLC), quantitative determination of the phytochemical marker using reference marker compound, information on pharmacological, clinical, toxicological aspects, dose, adulterants / substitutes etc.
The present 10th volume in the series contains quality standards of 35 medicinal plants. The monographs are outcome of the ICMR programme carried out at Agharkar Research Institute, Pune, Maharashtra; Captain Srinivasa Murti Drug Research Institute for Ayurveda, Chennai, Tamil Nadu; Centre for Medicinal Plants Research, Arya Vaidya Sala, Kottakkal, Kerala and L. M. College of Pharmacy, Ahmedabad, Gujarat.
As with the earlier nine volumes published, the tenth 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 Eleventh volume in the series is in progress.
Lack of quality standards of the raw material has been one of the major lacuna in the wider acceptance of plant based drugs. Medicinal Plants U nit of the Indian Council of Medical Research has initiated a programme for the preparation of quality standards for herbal raw materials involving several research institutes of country to address this problem. This programme has resulted in publication of nine volumes on "Quality Standards of Indian Medicinal Plants" covering 309 plants. The present volume is l O" in this series and contain monographs on 35 plants.
Chemical Constituents: Are given with the structures of important compound and active principles (if known). 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, vir., 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. 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.
Assay/Analytical Methods: Are described in detail for the analysis of marker compound. In certain cases, chemical groups are estimated. In all the case, sample preparation is optimized to enable complete extraction of compounds of interest.
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 detail and chromatograms, supported with complete references of the work cited.
In the initial pages of the book abbreviations used are listed, and the plants included in the first nine volumes are also listed for ready reference. Towards the end of the volume, relevant appendices are included, carrying details of the methods for pharmacognostic evaluation of the raw material which includes macroscopic, microscopic studies and the quantitative standards (Appendix I), phytochemical evaluation (Appendix II), methods for the isolation of markers (Appendix ill), methods of drying and storage of raw material (Appendix IV), limits of pesticide residues and microbial contamination (Appendix V) and plants allocated to various institutes for preparing the monographs (Appendix VI). The appendices section is followed by indices on the botanical names, chemical constituents and names of plants in other languages.
Edition: 2013
Medicinal plants play a significant role both in developed and developing countries in providing health benefits to human beings. Over the last few decades use of complimentary alternative medicines which are essentially plant based, have experienced a remarkable and steady increase in the world. This has generated a multifaceted interest in the medicinal plants including the sourcing of raw material, preparation of formulations, multimarker based phytochemical evaluation for standardization, molecular target based assays, pharmacological, toxicological and clinical evaluation to establish safety and efficacy of single plant drugs as well as polyherbal formulations and their large scale manufacture and marketing. In such a scenario proper quality controls of the herbal raw material as well as the finished products become essential. This activity has necessitated the requirement of good quality of raw material, consequently it became important to establish quality parameters of the raw material.
In response to this need, the Indian Council of Medical Research took initiative in the year 2001 to lay down quality standards of important Medicinal plants as per WHO guidelines. The endeavour yielded very fruitful results evidenced by the publication of 10 volumes of Quality Standards of Indian Medicinal Plants containing 344 monographs. Under this continuing programme, this eleventh volume of Quality Standards of another 35 Indian Medicinal Plants is being published. This endevour may help in improving quality of plant based drugs in our country.
I deeply appreciate the efforts of the chairman and the members of the various committees, viz., Scientific Advisory Group, the Task Force and the Technical Review Committee as also the important role played by the investigators and the Collaborative Research Institutions who have contributed to the significant task of developing quality standard monographs.
In India about 90 percent of 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 becomes essential.
In an effort to address this problem, the ICMR initiated work an Quality Standards of Indian Medicinal Plants, involving laboratories of reputed institutes of the country to generate requisite data as per prescribed format for preparing monographs.
Each monograph is titled with botanical nomenclature and incorporates diagnostic macro- and microscopic features, phytochemical constituents, identification by chromatographic fingerprints (TLC/GLCIHPLCIHPTLC), quantitative determination of the phytochemical marker using reference phytochemical standards, information on pharmacological, clinical, toxicological aspects, dose, adulterants/substitutes etc.
The present 11th volume in the series of the already published 10 volumes contains quality standards of35 medicinal plants. The present publication is an outcome of the ICMR programme under which work was carried out at Agharkar Research Institute, Pune, Maharashtra; Captain Srinivasa Murti Drug Research Institute for Ayurveda and Siddha, Chennai, Tamil Nadu; Centre for Medicinal Plants Research, Arya Vaidya Sala, Kottakkal, Kerala; Institute of Chemical Technology, Mumbai, Maharashtra; Jamia Hamdard, New Delhi and L. M. College of Pharmacy, Ahmedabad, Gujarat.
It is hoped that the current volume like the previous ones will also be of interest to the herbal drug industry, pharmaceutical and Ayurvedic academic/research institutes, practitioners of the Indigenous Systems of medicine and health professionals including regulatory authorities.
Preparation of the twelfth volume in the series is in progress.
Lack of quality standards of the raw material has been one of the major lacuna in the wider acceptance of plant based drugs. Medicinal Plants Unit of the Indian Council of Medical Research has initiated a programme for the preparation of quality standards for herbal raw materials involving several research institutes of the country to address this problem. This programme has resulted in publication often volumes on "Quality Standards of Indian Medicinal Plants" covering 344 plants. The present volume is 11th in this series and contains monographs on 35 plants.
In the initial pages of the book abbreviations used are listed, and the plants included in the first ten volumes are also listed for ready reference. Towards the end of the volume, relevant appendices are included, carrying details of the methods for pharmacognostic evaluation of the raw material which includes macroscopic, microscopic studies and the quantitative standards (Appendix I), phytochemical evaluation (Appendix II), methods for the isolation of markers (Appendix III), methods of drying and storage of raw material (Appendix IV), limits of pesticide residues and microbial contamination (Appendix V) and plants allocated to various institutes for preparing the monographs (Appendix VI). The appendices section is followed by indices on the botanical names, chemical constituents and names of plants in other languages.
Edition: 2014
Medicinal plants play a significant role both in developed and developing countries in providing health benefits to human beings. Over the last few decades plant based medicines have been steadily gaining importance in the world. This has generated a multifaceted interest in the medicinal plants, including sourcing of raw material, preparation of formulations, multimarker based phytochemical evaluation for standardization, molecular target based assays, pharmacological, toxicological and clinical evaluation to establish safety and efficacy of single drugs as well as polyherbal formulations and their large scale manufacture and marketing. In such a scenario proper quality control of the herbal raw as well as the finished products becomes essential. This activity has necessitated the requirement of good quality of raw material, consequently it became important to establish quality parameters of the raw materials.
In response to this growing need, Indian Council of Medical Research took initiative in the year 200 1 to lay down quality standards of important Medicinal plants as per WHO guidelines. The endeavour yielded very fruitful results evidenced by the publication of 11 volumes of Quality Standards of Indian Medicinal Plants containing 379 monographs. Under this continuing programme, this twelfth volume of Quality Standards of another 35 Indian Medicinal Plants is being published.
Despite certain limitations that these standards may have, it is a step towards improving the quality of finished products.
I deeply appreciate the efforts of the chairman and the members of the various committees, viz., Scientific Advisory Group, the Task Force and the Technical Review Committee as well as investigators and the various Research Institutions who have contributed to the significant task of developing quality standard monographs.
In India about 90 per cent of 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.
In an effort to address this problem, ICMR initiated work on Quality Standards of Indian Medicinal Plants, involving laboratories of reputed institutes of the country to generate requisite data as per prescribed format for preparing monographs.
Each monograph is titled with botanical nomenclature and incorporates diagnostic macro and microscopic features, phytochemical constituents, identification by chromatographic fingerprints (TLCIGLC/HPLC/HPTLC), quantitative determination of the phytochemical marker using marker compound, information on pharmacological, clinical, toxicological aspects, dose, adulterants/ substitutes etc.
The present 12th volume in the series of the already published 11 volumes contains quality standards of 35 plants. The present publication is an outcome of the ICMR programme under which work was carried out at Agharkar Research Institute, Pune, Maharashtra; Centre for Medicinal Plants Research, Arya Vaidya Sala, Kottakkal, Kerala; Institute of Chemical Technology, Mumbai, Maharashtra and Jamia Hamdard, New Delhi.
It is hoped that the current volume like the previous volumes will also be of interest to the herbal drug industry, pharmaceutical and Ayurvedic academic/research institutes, practitioners of the Indigenous systems of medicine and health professionals including regulatory authorities.
Preparation of the thirteenth volume in the series is in progress.
Lack of quality standards of the raw material has been one of the major lacuna in the wider acceptance of plant based drugs. Medicinal Plants Unit of the Indian Council of Medical Research has initiated a programme for the preparation of quality standards for herbal raw materials involving several research institutes of the country to address this problem. This programme has resulted in publication of eleven volumes on "Quality Standards of Indian Medicinal Plants" covering 379 plants. The present volume is 12th in this series and contains monographs on 35 plants.
Quantitative Standards: With respect to extractive values and ash values, these 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.
In the initial pages of the book abbreviations used are listed, and the plants included in the first eleven volumes are also listed for ready reference. Towards the end of the volume, relevant appendices are included, carrying details of the methods for pharmacognostic evaluation of the raw material which includes macroscopic, microscopic studies and the quantitative standards (Appendix I), phytochemical evaluation (Appendix II), methods for the isolation of markers (Appendix III), methods of drying and storage of raw material (Appendix IV), limits of pesticide residues and microbial contamination (Appendix V) and plants allocated to various institutes for preparing the monographs (Appendix VI). The appendices section is followed by indices on the botanical names, chemical constituents, names of plants in other languages and a list of monographs published in the earlier volumes (Vols 1-11).
In India about 90 percent of 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.
In an effort to address this problem, ICMR initiated work a Quality Standards of Indian Medicinal Plants, involving laboratories of reputed institutes of the country to generate requisite data as per prescribed format for preparing monographs.
Each monograph is titled with botanical nomenclature and incorporates diagnostic macro- and microscopic features, phytochemical constituents, identification by chromatographic fingerprints, (TLC/GLC/HPL/HPTLC), quantitative determination of the phytochemical marker using marker compound, information on pharmacological, clinical, toxicological aspects, dose, adulterants/ substitutes etc.
The present 13th volume in the series of already published 12 volumes contains quality standards of 35 plants. The present publication is an outcome of the ICMR programme under which work was carried out at Agharkar Research Institute, Pune, Maharashtra; Captain Srinivasa Murti Drug Research Institute for Ayurveda, Chennai, Tamil Nadu; Centre for Medicinal Plants Research, Arya Vaidya Sala, Kottakkal, Kerala; Institute of Chemical Technology, Mumbai, Maharashtra and Jamia Hamdard, New Delhi.
It is hoped that the current volume like the previous volumes will also be of interest to the herbal drug industry, pharmaceutical and Ayurvedic academic/research institutes, practitioners of the Indigenous systems of medicine and health professional including regulatory authorities.
Preparation of the fourteenth volume in the series is in progress.
Lack of quality standards of the raw material has been one of the major lacuna in the wider acceptance of plant based drugs. Medicinal Plants Division of the Indian Council of Medical Research has initiated a programme for the preparation of quality standards for herbal raw materials involving several research institutes of country to address this problem. This programme has resulted in publication of twelve volumes on "Quality Standards of Indian Medicinal Plants" covering 414 plants. The present volume is 13th in this series and contains monographs on 35 plants.
The raw material of the plants is procured from the field, from at least three geographical locations and authenticated. The samples are worked out for their pharmacognostic and phytochemical features through experiments while the information on the distribution of the plants, vernacular names, chemical constituents, pharmacological activity, safety aspects, clinical studies if any, therapeutic claims and any other details are derived from the published literature and compiled in the form of a monograph, along with complete references of the work cited. The experiments conducted and the compiled data is subjected to careful scrutiny by the exerts of the scientific committee. The information incorporated in the monographs is further supported by the photographs of the plant, the parts of the plant used, microscopic details, the TLC details, chromatograms, etc.
Chemical Constituents: Are given with the structures of important compounds and active principles (if known). While making the structures of the chemical constituents, stereochemistry is also taken into consideration wherever information on stereochemistry of specific compounds is available.
In the initial pages of the book abbreviations used are listed, and the plants included in the first twelve volumes are also listed for ready reference. Towards the end of the volume, relevant appendices are included, carrying details of the methods for pharmacognostic evaluation of the raw material which includes macroscopic, microscopic studies and the quantitative standards (Appendix I), phytochemical evaluation (Appendix II), methods for the isolation of markers (Appendix III), methods of drying and storage of raw material (Appendix IV), limits of pesticide residues and microbial contamination (Appendix V) and plants allocated to various institutes for preparing the monographs (Appendix VI). The appendices section is followed by indices on the botanical names, chemical constituents, names of plants in other languages and a list of monographs published in the earlier volumes (Vols 1-12).
Medicinal Plants play a significant role both in developed and developing countries in providing health benefits to human beings. Over the last few decades plant based medicines have been steadily gaining importance in the world. This has generated a multifaceted interest in the Medicinal Plants, including sourcing of raw material, preparation of formulations, multimarker based phytochemical evaluation for standardization, molecular target based assays, pharmacological, toxicological and clinical evaluation to establish safety and efficacy of single drugs as well as polyherbal formulations and their large scale manufacture and marketing. In such a scenario proper quality control of the herbal raw as well as the finished products becomes essential. This activity has necessitated the requirement of good quality of raw material, consequently it became important to establish quality parameters of the raw materials.
In response to this growing need, Indian Council of Medical Research took initiative in the year 2001 to lay down quality standards of important Medicinal Plants as per WHO guidelines. The endeavour yielded very fruitful results evidenced by the publication of 12 volumes of Quality Standards of Indian Medicinal Plants containing 414 monographs. Under this continuing programme, this thirteenth volume of Quality Standards of another 35 Indian Medicinal Plants is being published.
The global interest in Medicinal Plants and the fast expanding world market during the last two decades have necessitated quality ensured herbal drugs. An increase in the incidence of toxicity reported due to indiscriminate use, deliberate or undeliberate adulteration/substitution and presence of contaminants in herbal preparations available over the counter and as food supplements make it important to ensure their quality. Quality Standards of the Indian Medicinal Plants are necessary for the drugs and formulations produced from them to be of adequate quality, safety and efficacy for their wider acceptance and patients interest.
In response to this growing need, Indian Council of Medical Research took initiative in the year 2001 to lay down quality standards of important Medicinal Plants as per WHO guidelines. The endeavour yielded very fruitful results evidenced by the publication of 13 volumes of Quality Standards of Indian Medicinal Plants containing 449 monographs. Under this continuing programme, this fourteenth volume of Quality Standards of another 35 Indian Medicinal Plants is being published.
Medicinal plants remain the main source of medicines for a large proportion of global population particularly in the developing world. In India the raw material for herbal medicinal products is mostly procured from wild sources, there is every possibility of vast variation of chemical constituents in the material collected from different geographical sources. There is also a possibility of deliberate adulteration and substitution in the genuine raw material. In such a scenario the proper quality control of the herbal raw materials as well as the finished products become essential. Moreover, the quality of raw materials used in the herbal drugs assumes special significance particularly in context of conducting experimental studies, clinical trials and their therapeutic value.
The Medicinal Plants Division of the Indian Council of Medical Research took initiatives for developing Quality Standards of Medicinal Plants for more widely used raw materials involving laboratories of reputed institutes in the country to generate requisite data as per prescribed format for preparing monographs. Each monograph is titled with botanical nomenclature and incorporats diagnostic macro- and microscopic features, phytochemical constitutents, identification by chromatographic fingerprints (TLC/GLC/HPLCIHPTLC), quantitative determination of the phytochemical marker using reference marker compound, information of pharmacological, clinical, toxicological aspects, dose, adulterants / substitutes etc.
The present 14th volume in the series of already published l3 volumes contains quality standards of 35 plants. The present publication is an outcome of the ICMR programme under which work was carried out at Captain Srinivasa Murti Drug Research Institute for Ayurveda, Chennai, Tamil Nadu; Centre for Medicinal Plants Research, Arya Vaidya Sala, Kottakkal, Kerala and Institute of Chemical Technology, Mumbai, Maharashtra.
Preparation of the fifteenth volume in the series is in progress.
Lack of quality standards of the raw material has been one of the major lacuna in the wider acceptance of plant based drugs. Medicinal Plants Division of the Indian Council of Medical Research has initiated a programme for the preparation of quality standards for herbal raw materials involving several research institutes of country to address this problem. This programme has resulted in publication of thirteen volumes on "Quality Standards of Indian Medicinal Plants" covering 449 plants. The present volume is 14th in this series and contains monographs on 35 plants.
Each monograph starts with the parte s) used, botanical name with authority, synonyms, habit and distribution of the plant.
Identity Tests: Chromatographic fingerprint profiles which have been generated using thin layer chromatography, high performance liquid chromatography or gas liquid chromatography, as per the suitability are given. TLC is found to be more practically 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.
. Pharmacology: Includes important pharmacological, clinical and other biological activities of the part or the plant described as drug. The information is derived in majority of the cases from the original published articles in journals of repute.
In the initial pages of the book abbreviations used are listed, and the plants included in the first thirteen volumes are also listed for ready reference. Towards the end of the volume, relevant appendices are included, carrying details of the methods for pharmacognostic evaluation of the raw material which includes macroscopic, microscopic studies and the quantitative standards (Appendix I), phytochemical evaluation (Appendix 11), methods for the isolation of markers (Appendix Ill), methods of drying and storage of raw material (Appendix IV), limits of pesticide residues and microbial contamination (Appendix V) and plants allocated to various institutes for preparing the monographs (Appendix VI). The appendices section is followed by indices on the botanical names, chemical constituents, names of plants in other languages and a list of monographs published in the earlier volumes (Vols 1-13).
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