Herbal Pharmacopoeia is a reference book for the preparation of quality medicines published by the authority of a Government and represents qualitative and therapeutic monographs on botanicals
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Comparison of various herbal pharmacopoeias.pptx
1. Quality Control & Standardization Of Herbals
Comparison of Various Herbal Pharmacopoeias
By
Kaushal Kumar
2. TABLE OF CONTENTS
01 02 03 04
Introduction Herbal
Pharmacopeia
Pharmacopoeia Indian
Pharmacopoeia
3. Introduction
Herbal Pharmacopoeia is a reference book for the preparation
of quality medicines published by the authority of a
Government and represents qualitative and therapeutic
monographs on botanicals.
► Herbal Pharmacopoeia is a compiled document which:
» Define a botanical drug
» Provides information for its proper identification
» Contains the basic description including:
→ Nomenclature → Plant part used
→ Active constituents → Range of application
→ Contraindication → Incompatibility
→ Uses & action
4. American Herbal Pharmacopoeia (AHP)
African Herbal Pharmacopoeia (AfrHP)
British Herbal Pharmacopoeia (BHP)
Korean Herbal Pharmacopoeia (KHP)
Pharmacopoeia of the People’s Republic of China (ChP)
The Turkish Pharmacopoeia (TP)
Pharmacopoeia Argentina
Brazilian Pharmacopoeia
Indian Herbal Pharmacopeia
Herbal Pharmacopoeia
5. The AHP develops qualitative and therapeutic monographs on botanicals
including,
many of the Ayurvedic, Chinese and Western herbs most frequently used in the
United States.
These monographs represent the most comprehensive and critically reviewed
body of information on herbal medicines in the English language and serve as a
primary reference for academicians, health care providers, manufacturers and
regulators.
American Herbal Pharmacopoeia (AHP)
6. The AfrHP provides comprehensive, up to date botanical, commercial and phytochemical
information on over 50 of the most important African medicinal plants.
The technical data were made on plant samples sourced from across the continent. These
monographs were prepared by leading African scientists and have been reviewed by
international experts.
Additional data includes, micro-morphology of the plant material, distribution maps and TLC
chromatograms.
These data are crucial for producers, collectors and traders in medicinal plants and extracts
as well as researchers, manufacturers and practitioners.
The scope, quality and standard of these herbal monographs are comparable to those
prepared in Europe, North America and Asia.
African Herbal Pharmacopoeia (AfrHP)
7. The BHP provides quality standards for 169 herbal raw materials.
European Pharmacopoeia Commission (Council of Europe) has led to the introduction of
many more herbal monographs in the European Pharmacopoeia.
The BHP monograph includes a brief description of the form of the material, its main
geographical sources, macroscopical and microscopical descriptions of the herbal material,
prepared by eminent pharmacognosists, together with odour and taste descriptions.
It also includes, comparative identification and qualitative phytochemical analysis.
However, the BHP remains a very useful aid to quality assurance, particularly for herbs not
featured in official pharmacopoeias.
British Herbal Pharmacopoeia (BHP)
8. The recent KHP contains a total of 2,462 official monographs (Part I and Part II).
Part I includes frequently used drugs and their primary preparations and
Part II includes crude drugs, biological drugs, radioactive drugs, combined
preparations, additives for preparations and quasi-drugs.
The Pharmacopoeia comprises the following items, in order, general notices,
general requirements for preparations, monographs, general tests, processes &
apparatus and general information followed by the index.
Korean Herbal Pharmacopoeia (KHP)
9. The Ministry of Health published the Republic of China’s first pharmacopoeia as Chinese
Pharmacopoeia in 1953.
Under the umbrella of the China Food and Drug Administration (CFDA), the Chinese
Pharmacopoeia Commission (ChPC) and its stakeholders (drug control institutions, research
institutions, universities and drug manufacturers) prepared the Chinese Pharmacopoeia in
line with the basic principles, goals and requirements of the era.
The Chinese Pharmacopoeia includes, monographs of vegetables, oil, fats and extracts,
medicinal materials and the prepared slices of Chinese crude drugs, single item
preparations, chemical drugs, antibiotics, biochemical and radioactive drugs, pharmaceutical
excipients and biologicals.
General chapters include, general requirements of preparations, testing methods, standard
substances, reagents and the guidelines.
Pharmacopoeia of the People’s Republic of China (ChP)
10. Turkish Pharmacopoeia includes European Pharmacopoeia monographs as well
as national monographs.
It has a section containing herbal, biological or biotechnological products and
finished products.
They are first published in the Turkish Pharmacopoeia Journal and then in the
Turkish Pharmacopoeia and become official.
In the latest version, the number of national monographs has reached 32 and
most of them are monographs of medicinal and aromatic herbal ingredients.
The Turkish Pharmacopoeia (TP)
11. Pharmacopoeia Argentina is published by The National Administration of
Medicines Food and Medical Technology and it is in the Spanish language.
Pharmacopoeia Argentina provides a specification for biological, herbal products,
medical products, blood products, radiopharmaceutical products, for vaccines and
includes general monographs and supplementary texts.
Pharmacopoeia Argentina
12. Brazilian Pharmacopoeia is published by Pharmacopoeia Coordination Brazilian
Health Surveillance Agency in three different languages, Portuguese, English and
Spanish.
Apart from Brazilian Pharmacopoeia, Herbal Medicines National Formulary
(Portuguese/ Spanish) and Herbal Medicines Memento (Portuguese) are also
used in Brazil.
Brazilian Pharmacopoeia provides specifications via monographs for APIs and
excipients, for dosage forms, for biological, for herbal products and includes
monographs for medical devices.
Brazilian Pharmacopoeia
13. The Indian Herbal Pharmacopoeia has 40 monographs published by the Indian Drugs
Manufacturers Association (IDMA) in collaboration with Regional Research Laboratory
(RRL), Jammu. Index of pharmacopoeias published by the World Health Association,
Geneva has a comprehensive list of pharmacopoeias of different countries.
Ayurvedic Pharmacopoeia of India (API) has monographs of 600 plants/animals/minerals
and derived drugs (Part 1. Volume 1 to 8).
Monographs of 152 compound Ayurvedic formulations are published in Ayurvedic
Pharmacopoeia of India (Part II, Volume 1 to 3).
Siddha Pharmacopoeia of India (Volume 1 and 2),
Homeopathic Pharmacopoeia of India (Volume 1 to 6) and
Unani Pharmacopoeia of India (Volume 1 to 6) are the standard books available for
Indian herbs.
Indian Herbal Pharmacopoeia
14. Quality standards of Indian Medicinal Plants by the Indian Council of Medical Research
(ICMR) are a non-pharmacopoeial masterpiece for reference on standards of Indian herbs.
Monographs on 449 plants (Volume 1 to 13) included in the book would help in improving
monographs in API and other Pharmacopoeias of Indian origin.
The Pharmacopoeia Commission for Indian Medicine (PCIM) under the Ministry of AYUSH is
fully functional to improve the Pharmacopoeias for Indian Herbs.
The first official Pharmacopoeia of India was published in 1868. The committee under the
chairmanship of Sir R. N. Chopra along with the other nine members prepared The Indian
Pharmacopoeial list.
It was prepared by the Department of Health, Govt of India, Delhi in 1946.
Indian Pharmacopoeia committee under the chairmanship of Dr B. N. Ghosh published the
first edition of IP in 1955. Supplement to this edition was published in 1960.
Indian Herbal Pharmacopoeia
15. Second edition of IP was published in 1966 under the chairmanship of Dr B. Mukherjee.
Official titles of monographs were given in English.
274 monographs from IP 1955 and their supplements were deleted.
Supplement to this edition was published in 1975. In this, 126 new monographs were included
and 250 monographs were amended.
Third edition of IP was published in 1985 with two volumes and nine appendices, 261 new
monographs were added.
Addendum I to IP was published in 1989 where 46 new monographs were added and 126
amended.
Addendum II was published in 1991 where 62 new monographs were added and 110 amended.
Fourth edition of IP was published in 1996 under the chairmanship of Dr Nityanand. It
covered 1149 monographs and 123 appendices. It included 294 new monographs and 110
monographs were deleted.
Indian Herbal Pharmacopoeia
16. Fifth edition of IP was published in 2007 and an addendum to this edition was published in
2008. IP 2007 was presented in three Volumes.
Volume 1 contains general notices and general chapters.
Volume II & III contain general monographs on drug substances, dosage forms and pharmaceutical aids.
Sixth edition of IP was published in 2010 by the Indian Pharmacopoeia Commission (IPC).
The Indian Pharmacopoeia 2010 was presented in three volumes.
Volume I contains the notices, preface, the structure of the IPC, acknowledgements,
introduction and the general chapters.
Volume II contains the general notice, general monographs on dosage forms and monographs
on drug substances and pharmaceutical aids (A to M).
Volume III contains monographs on drug substances, dosage forms and pharmaceutical aids (N to
Z). It also includes monographs on vaccines and immunosera for human use. Herbs and herbal
products, blood and blood-related products, biotechnology products and veterinary products.
Indian Herbal Pharmacopoeia
17. Seventh Edition of the Indian Pharmacopoeia (IP 2014) was published by the Indian
Pharmacopoeia Commission (IPC) on behalf of the Government of India, Ministry of Health and
Family Welfare.
The Indian Pharmacopoeia 2014 was presented in four volumes.
The IP 2014 included 2550 monographs of drugs out of which 577 are new monographs consisting of APIs,
excipients, dosage forms and herbal products, etc.
Eighth Edition of the Indian Pharmacopoeia (IP 2018) was published by the Indian Pharmacopoeia
Commission (IPC) on behalf of the Ministry of Health and Family Welfare, Government of India.
IP 2018 was brought out in four volumes incorporating 220 new monographs including –
170 New chemical monographs 15 Herbal monographs
10 Blood & blood-related products 02 vaccines and immunosera for human use
03 Radiopharmaceutical monographs 06 Biotechnology-derived therapeutic products
14 veterinary monographs 366 Revised monographs
7 Monographs have been deleted 49 API,
64 Formulation 02 Excipients 02 Antibiotics
Indian Herbal Pharmacopoeia
18. Indian Pharmacopoeia
Edition Year Addendum Chairmanship Volume
1st 1955 1960 Dr B. N. Ghosh One
2nd 1966 1975 Dr B. Mukherjee One
3rd 1985 1989/1991 Dr Nityanand Two
4th 1996 2000/02/05 Dr Nityanand Two (Blue)
5th 2007 2008 Dr Nityanand Three (Blue)
6th 2010 2012 Shri
K.Chandramouli
Three (Blue)
7th 2014 2015/2016 Nabi Azad Four (Red)
8th 2018 2019/2021 Dr C.K Mishra Four (Orange)
19. THANKS!
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