IAM DR AJITH KUMAR HERE TO SHARE MY VIEWS ON AFI AND API.

1. AN OVERVIEW OFAPI, AFI, AND
OTHER INTERNATIONAL
PHARMACOPOEIAS
By – Dr Ajith kumar
Final Year P.G Scholar
Dept. of Rasashastra and Bhaishajya kalpana
Under the guidance of : Dr P.G Jadar M.D Ayu PhD
Professor and Dean
Dept of PG Studies in Rasashastra and bhaishajya kalpana

2. Topics covered
Introduction
Need for pharmacopoeia in Ayurveda
The APC
General introduction to pharmacopoeia
A brief overview of API
Formulary and AFI
Other International pharmacopoeias
Summary
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3. Introduction
Drug and Cosmetic Act 1940 – regulation of import, manufacture,
and distribution of drugs in India
Primary objective of the act – ensure safety, efficacy, and quality
standards of drugs and cosmetics sold in India.
Amended in 1964 to include Ayurvedic and Unani drugs
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4. Need for a pharmacopoeia in Ayurveda?
Controversy and confusion in identification of drugs.
Widespread geography of the country – multiple botanical sources of a drug.
Commercial substitution.
Foreign invasions, discouragement and negative attitude towards the system – Ayurvedic drugs
were wrongly published as crude, poisonous, and potentially dangerous.
Government had no control over manufacturing and marketing. Hence no control over quality
of these products.
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5. The Ayurvedic Pharmacopoeia Committee (APC)
Constituted by Govt of India on 20th September 1962
First functional unit of ministry of AYUSH
Purpose – to establish safety and toxicity profiles and standardize drugs and
formulations mentioned in our classics.
From 2006 it’s under CCRAS
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6. As a result…
Unavailable laboratory data to feed monographs – PLIM ( Pharmacopoeia Laboratory of Indian
Medicine) was established in 1970 in Ghaziabad.
3 publications : AFI, API, and Atlas of Ayurvedic Pharmacopoeia drugs
AFI was published first in 1978, under Col. R N Chopra Committee which would provide
sufficient basis to enforce Drug and Cosmetic Act and also would be precursor to publish API
API was then published in 1986
ATLAS – 2009 (TLC) and 2011 (microscopy and macroscopy)
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7. Pharmacopoeia
Derived from Greek, the word meaning is “drug-making”
What? – A legally binding collection for medicines used in a region
Who? – Prepared by national or regional authority
Why? – To state standards and quality specifications for medicines
Hence it can be defined as “It is a legally binding collection, prepared by a
national or regional authority of standards and quality specifications for
medicines used in that country or region.”
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8. Role of pharmacopoeia
The role of a pharmacopoeia is to furnish quality specifications for active
pharmaceutical ingredients (APIs), finished pharmaceutical products (FPPs), and
general requirements, e.g. for dosage forms.
Quality specification :
It includes a set of tests that will help determine :
1. Quality and purity of a product
2. Ascertain the strength and amount of active ingredients in a product
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9. API – THE AYURVEDIC PHARMACOPOEIA OF INDIA
- The API is a legal document of standards for the quality of
ayurvedic drugs
- It provides us some uniformity in the ayurvedic medicines
marketed, so far as their identity, purity and strength are
concerned.
- It is the book of reference for implementation of the drugs
and cosmetics act (1940).
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10. Division of content
• API – PART 1
• Total 9 volumes
• 645 monographs on single drugs
• Vol.7 deals with metal and mineral origin
drugs
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volume Year of publication No of monographs
I 1990 80
II 1999 78
III 2001 100
IV 2004 68
V 2006 92
VI 2008 101
VII 2008 21(metals and
minerals)
VIII 2011 60 (aqueous and
hydroalcoholic
extracts)
IX 2016 45

11. •API part II
•3 volumes have been published
101 monographs.
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volume Year of publication No of monographs
I 2007 50 (formulations)
II 2008 51
III 2010 51

12. TLC Atlas of Ayurvedic Pharmacopoeial Drugs – Part 1, Vol. 1 – 2009 – 80
monographs
Microscopy and Macroscopy Atlas of API Drugs – Part 1, Vol. 1 – 2011 – 80
monographs
Microscopy and Macroscopy Atlas of API Drugs – Part 1, Vol. 5 – 2009 – 92
monographs
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13. Contents of API
Preface
Introduction
Legal notices
General notices - for guidance of the analysts, the pharmaceutical suppliers, manufacturers
and the research workers engaged in this field.
Monographs
Appendices- details about the apparatus, reagents and solutions, tests, methods of preparations
of specimen for microscopic examinations have been given.
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14. MONOGRAPHS
• Title
• Definition - giving its identification in scientific nomenclature and very brief information
about its source, occurrence, distribution and precautions in collection if any etc, are mentioned
• Synonyms- in Sanskrit and also other Indian regional languages
• Description : Macroscopic – morphological characteristics and
Microscopic- its microscopic structure, the individual elements,
deposition of crystals etc. each having a pharmacognostic value in
identification.
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15. • Identity, purity and strength – gives norms and limits like tolerance of
foreign matter alcohol soluble extract
total ash water soluble extract
acid insoluble ash moisture content
• Constituents
• Properties and action- rasa panchakas
• Important formulations
• Therapeutic uses
• Dose
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16. Formulary
It is a list of prescription drugs/medicines.
Contains collection of formulas for the compounding and testing of
medication.
Depending on individual formularies, some may also contain additional
clinical information such as side effects, contraindications, and doses.
156 countries – national or provincial essential medicine lists
135 countries – national treatment guidelines/formulary manuals
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17. AFI – THE AYURVEDIC FORMULARY OF INDIA
Huge number of formulations scattered all over was
compiled.
List of single drugs of animal, mineral, and plant origin was
prepared on basis of names appearing in formulations, along
with official names and English equivalents.
Plant origin drugs have been edited according to botanical
names of plants appearing in formulations for convenience of
users.
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18. Other features
Ayurvedic terms of therapeutic indications and their appropriate English
equivalent has been mentioned.
The original shloka of reference from where the shloka has been derived has also
been included
Keeping in mind the non-availability of roots and barks and regulating laws of
the country, alternative parts of the plants have been indicated for the
formulations
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19. Division of content
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22. Contents of AFI
Foreword
- Legal notice
- General notices
- Transliteration symbols
- Abbreviations for parts of plants
- Preface
- Introduction
- Formulary—compound formulations:
- Formulary—single drugs:
1. List of single drugs of animal origin.
2. List of single drugs of mineral origin.
3. List of single drugs of plant origin:
- Appendices:
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23. Formulary – compound formulations
Name of formulation in samskrit
Reference
Shloka
Name of drugs mentioned in shloka along with their : basonym (if synonym is given in shloka),
part used, quantity
Dose
Important therapeutic uses
Special method of preparation is mentioned only for some formulations
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27. Formulary – single drugs of animal origin - 114
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28. Formulary – single drugs of mineral origin - 179
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29. Formulary – single drugs of plant origin - 1048
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30. Appendicies
Appendices:
1. Paribhasa (Glossary of technical terms).
2. Sodhana (Process of detoxication).
3. Therapeutic indices:
(a). Formula wise.
(b). Disease wise.
4. List of diseases/technical terms and their approximate English
equivalents.
5. Metric equivalents of classical weights and measures.
6. Bibliography.
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31. Paribhasha
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32. Shodhana
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33. Therapeutic indices
(formula wise)
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34. Therapeutic indices
(disease wise)
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35. Dosage forms and doses mentioned in AFI
Sl. No Dosage form General dose
1 Asava and Arista 12 to 24 ml
2 Arka 12 to 24 ml
3 Avaleha and Paka 6 to 12 gm
4 Kwatha churna 48 gm
5 Guggulu 3 gm
6 Ghrita 12 gm
7 Churna 1 to 6 gm
8 Taila 6 to 12 gm
for internal use
9 Dravaka 5 drops
10 Lavana kshara 1 to 2 gm
125 – 250 mg
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Sl.
No
Dosage form General dose
11 Lepa --
12 Vati and gutika 125 mg to 2 gm
13 Varti, Netrbindu, Anjana --
14 Sattva 1 gm
15 Kupipakva rasayana 62.5 to 125 mg
16 Parpati 125 to 250 mg
17 Pishti 62 to 125 mg (few
upto 500mg)
18 Bhasma upto 250 mg
19 Mandura 1 gm
20 Rasa yoga 125- 250 mg
21 Lauha 250 mg to 2 gm

36. Dose- general guidelines
Doses : Doses mentioned in the Formulary are intended merely for general
guidance
Represent, unless otherwise stated, the average range of quantities per dose which
are generally regarded as suitable for adults when administered orally.
It is not to be regarded as binding upon the prescribers.
It is to be noted that the relation between the doses in metric and Ayurvedic
Systems set forth in the text is of only approximate equivalence, and are for the
convenience of the prescriber and are sufficiently accurate for pharmaceutical or
other purposes.
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37. Different parts of plants to be used mentioned in API - 66
37

38. 38

39. 39

40. Other International Pharmacopoeias
WHO lists 30+ pharmacopoeias from 149 independent countries

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Topics

44. To summarize…
Pharmacopoeias and formularies - Guidelines for approved
pharmaceutical standards – necessary for manufacture and
prescription of these formulations
Ensure quality control methods
An important component of the drug safety system
An instrument for patient and consumer protection
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