2. INTRODUCTION
Pharmacopoeia is an official code containing a
list of established drugs and medicinal
preparations.
Pharmacopoeia literally means “DRUG MAKING”
Derived from Greek word- PHARMAKOPOIIA
PHARMAKON- Drug
THE VERB POIIA- Making
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3. AYURVEDIC PHARMACOPOEIA OF INDIA
API is the book of standards for single drug and
it’s formulations
Published by ministry of ayush
Description of each single drug or preparation
included in it are called monographs
There are 645 monographs in part – 1 and 202
monographs in part - 2
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4. AYURVEDIC PHARMACOPOEIA COMMITTEE
APC was first functional unit in the department of
ayush.
Constitution of APC established on 20th sept 1962 by
government of india.
In April 2006, it was shifted under central council for
research in Ayurveda and siddha (CCRAS)
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5. OFFICIAL AND ESSENTIAL PUBLICATIONS OF
APC
AYURVEDIC PHARMACOPOEIA OF INDIA
AYURVEDIC FORMULARY OF INDIA
ATLAS OF AYURVEDIC PHARMACOPOEIA
OF INDIA
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6. OTHER OFFICIAL MONOGRAPHS
GERMAN COMMISSION E MONOGRAPHS
EUROPEAN SCIENTIFIC COOPERATIVE FOR
PHYTOTHERAPY (ESCOP)
THE AMERICAN HERBAL PHARMACOPOEIA
WHO MONOGRAPHS
USP MONOGRAPHS
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8. APC - FUNCTIONS
To prepare Ayurvedic Pharmacopoeia of single and compound
drugs
To prescribe the working standards for compound ayurvedic
formulations including tests for identity, purity, strength and
quality so as to ensure uniformity of finished formulations.
To prepare remaining parts of official formulary of compound
preparations from the classical texts including standardized
composition of reputed institution.
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9. APC - FUNCTIONS
To develop and standardize methods of preparation, dosage form,
toxicity profile etc.
To develop quality standards, safety, efficacy profile of
intermediates like extracts of ayurvedic raw drugs.
To develop quality standards, safety, efficacy profile of different
parts of plants, as well as to include new plants as ayurvedic
drugs.
Any other matter relating to the quality standards, shelf life,
identification, new formulations.
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10. PROJECTS UNDER APC
Development of pharmacopoeial standards for single
drug and it’s formulations.
Isolation of marker compounds of medicinal plants.
Comparative phyto-chemical screening of roots and
barks vs aerial parts.
Preparation of hindi version of API.
Biological activity studies of plant extract.
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11. PROJECTS UNDER APC
To identify methods and procedures for publication of standards of all
commonly used formulations of AFI.
Information on ayurvedic formulation regarding
- Distinguishing characters
- Method of preparation and dosage
- Method of administration with anupana
- Toxicity
To develop quality standards, shelf life, identification, new formulations
including safety, efficacy of intermediate plant extracts.
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12. APC & PLIM
In 2010 – pharmacopoeia Laboratory for Indigenous Medicines
(PLIM)
Autonomous body for Indian medicine (Ayurveda, sidda, unani) to
evolve the standards under the guidance of APC
To analyse the product samples picked up by the drug inspectors
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13. PLIM - OBJECTIVES
To set and validate standards of drugs
To provide reference standards
To impart training to drug inspectors and
analysts
To provide support to APC
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14. API – PART 1
VOLUME YEAR OF PUBLISHING NUMBER OF MONOGRAPHS
I 1990 80 (raw drugs)
II 1999 78
III 2001 100
IV 2004 68
V 2006 92
VI 2008 101
VII 2008 21(minerals)
VIII 2011 60(on 15 plants)
IX 2016 45 ( dry drugs)
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15. API – PART 2
VOLUME YEAR OF PUBLISHING NUMBER OF MONOGRAPHS
I 2007 50
II 2008 51
III 2010 51
IV 2017 50
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17. API – SUPPORTING PHARMACOPOEIAL
PUBLICATIONS
TLC ATLAS OF API PART 1
VOL - 1 – 2009 – 80 MONOGRAPHS
VOL – 3 – 2016 – 99 MONOGRAPHS
MICROSCOPY AND MACROSCOPY ATLAS OF API –
PART 1
VOL I – 2011 – 80 MONOGRAPHS
VOL V – 2009 – 92 MONOGRAPHS
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18. A TYPICAL MONOGRAPH OF API
TITLE
NAME OF MONOGRAPH
SYNONYMS
DESCRIPTION (MACROSCOPIC & MICROSCOPIC)
IDENTITY, PURITY AND STRENGTH
FOREIGN MATTER
TOTAL ASH
ACID-INSOLUBLE ASH
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19. A TYPICAL MONOGRAPH OF API
ALCOHOL - SOLUBLE EXTRACTIVE
WATER – SOLUBLE EXTRACTIVE
ASSAYS AND TESTS
CONSTITUENTS
PROPERTIES AND ACTION
IMPORTANT FORMULATIONS
THERAPEUTIC USES
DOSE
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21. AFI (FORMULATIONS)
FORMULATION IS DEFINED AS USE OF MORE THAN ONE DRUG IN
MEDICINAL PREPARATION.
The 1st part of ayurvedic formularly in English was published in
1978
This was the 1st attempt of APC to compile the information
scattered about ayurvedic compound formulations in such a way
to make it suitable to develop pharmacopoeial standard and to
meet the requirements of drug and cosmetic act
List of single drugs of animal, mineral and plant origin has been
prepared on the basis of names appeared in the formulations.
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22. AFI ( FORMULATIONS)
Compound formulations are divided into two groups
1. kasthaushadhi (predominantly plant drugs)
2. Rasaushadi ( metals and minerals)
Kasthaushadhi – asava, arista, avaleha, ghrita, churna, taila
Rasaushadhi – bhasma, pisti, lauha, mandura, kupipakva rasayana
Both 1st and 2nd part contain majority of formulations
manufactured as per classics
3rd Part has formulations that has been used by hospital
pharmacies for over 50 years
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23. GENERAL STRUCTURE OF AFI (FORMULATIONS)
TITLE
METHOD OF PREPARATION
DOSE
ANUPANA
THEURAPEUTIC USES
STORAGE
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24. AFI - PUBLICATIONS
PART YEAR OF PUBLISHING NUMBER OF MONOGRAPHS
I 1976 444
II 2000 192
III 2011 350
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27. CONCLUSION
API IS A BOOK OF AYURVEDIC MONOGRAPHS WHICH GIVES
PHYSICAL PROPERTIES, MICROSCOPIC & MACROSCOPIC
CHARACTERS, IDENTITY TESTS, CONSTITUENTS, APPROVED
THERAPEUTIC USES, MINIMUM AND MAXIMUM DOSES, COLOUR
PHOTOGRAPHS, CHEMICAL FORMULATIONS AND STANDARDS OF
QUALITY OF CRUDE DRUGS INCLUDING ITS FORMULATIONS.
THE AIM HAS BEEN SET STANDARDS FOR QUALITY, EFFICACY AND
SAFETY IN ORDER THAT MANY TRADITIONAL HERBS AND
FORMULATIONS MEET LEGAL REQUIREMENT.
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