AYURVEDIC
PHARMACOPEIA OF
INDIA (API)
API
INTRODUCTION
• The word pharmacopeia is composed of two Greek words; pharmakon,meaning medicine or
charm and poiein,meaning to make.
• It is an official code containing a list of established drugs and medicinal preparations.
• Ayurvedic Pharmacopeia of India is a legalized document of the Government of India which
describes the quality, purity and strength of selected drugs that are manufactured, distributed,
and sold by the licensed manufacturers across India.
• Once approved by [The Ayurvedic Pharmacopeia Committee (APC)], compliance with the quality
prescribed in API becomes mandatory under the Drugs and Cosmetics Act 1940.
• This pharmacopeia has established standards to evaluate identity, quality and purity of herbs
and formulations.
•
AYURVEDIC PHARMACOPOEIA COMMITTEE
• APC was first function 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
Ayurvedic and siddha (CCRAS).
OFFICIAL AND ESSENTIAL PUBLICATIONS OF
APC
• Ayurvedic pharmacopoeia of India.
• Ayurvedic formulary of India.
• Atlas of Ayurvedic pharmacopoeia of India.
OTHER OFFICIAL MONOGRAPHS
• German commission e monographs.
• European scientific cooperative for phytotherapy (ESCOP).
• The American herbal pharmacopoeia.
• WHO monographs.
• USP monographs.
NEED FOR ESTABLISHING PHARMACOPEIA
FOR AYURVEDA DRUGS
• The raw herb market has challenges of adulterations, substitution of
medicinal plants and with increased demand for raw herbs; there is a
dire need of standards for identity, quality and purity.
• With the sole objective to establish these standards for herbal raw
material and formulations, API has been published.
APC - FUNCTION
• 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.
• 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.
THE PRIMARY OBJECTIVE OF THE AYURVEDIC
PHARMACOPOIA OF INDIA (API)
• To establish and maintain quality standards for ayurvedic medicines by
defining detailed specifications for the identity, purity and strength of
both single herbal drugs and compound formulations, ensuring safety
and efficacy of ayurvedic medications manufactured and sold in India,
all based on traditional ayurvedic texts and scientific validation;
essentially acting as a reference point for quality control of ayurvedic
drugs.
KEY POINTS ABOUT THE API’S OBJECTIVES
STANDARDIZATION:
To set clear standards for Ayurvedic drugs, including raw materials and finished formulations, through detailed monographs
outlining identification tests, constituents, and physicochemical parameters.
QUALITY ASSURANCE:
To promote the production of safe and effective ayurvedic medicines by establishing quality control measures for manufacturers to
adhere to.
SCIENTIFIC VALIDATION:
To incorporate scientific research and analysis methods to validate the efficacy and safety of ayurvedic drugs while staying true to
traditional ayurvedic principles.
REGULATION COMPLIANCE:
To enable regulatory bodies to effectively monitor and enforce quality standards for ayurvedic drugs under the drugs and
cosmetics act.
PUBLIC HEALTH PROTECTION:
To safeguard public health by ensuring the quality and consistency of ayurvedic medicines available in the market.
WHAT THE API CONTAINS
MONO-MONOGRAPHS:
Descriptions of individual drugs of natural origin, including their macroscopic characteristics.
COMPOUND FORMULATIONS:
Standards for selected compound formulations from ayurvedic classics.
CHEMICAL STANDARDS:
Standards for the identity, purity, and strength of drugs.
PERMISSIBLE LIMITS:
Limits for foreign matter, total ash, acid insoluble ash, alcohol soluble extractive, and water soluble extractive.
WEIGHTS AND MEASURES:
Information about weights and measures used in ayurveda.
APPROXIMATE EQUIVALENTS:
Equivalents of doses in the Indian system and the metric system.
API PUBLICATIONS AND VOLUMES
• Ayurvedic pharmacopeia of India- part 1: Monographs on single drugs have been
published which includes herbs; minerals and extracts. The following table enlists
the volume, its year of publication with the total number monographs described in
each.
• Ayurvedic pharmacopeia of India- part 1: As a supporting material for API-part 1, an
atlas on Thin Layer Chromatography (TLC) and Macroscopy and Microscopy are
under publication. The presently available volumes are presented in the table.
• Ayurvedic pharmacopeia f India- part 2: Monographs on formulations have been
published.
VOLUME & YEAR MONOGRAPHS
• Vol. 1, 1986 80
78
• Vol. 2, 1999
100
• Vol. 3, 2001
68
• Vol. 4, 2004 92
• Vol. 5, 2006 101
• Vol. 6, 2008 21
60
• Vol. 7, 2008 (Minerals & Metals)
45
• Vol. 8, 2011 (Hydro-alcoholic & Water extracts)
20
• Vol. 9, 2016 (Hydro-alcoholic &Water extract)
• Vol. 10, 2022 (Minerals & Metals)
• Vol. 1, 2007 • 50
• Vol. 2, 2008 • 51
• Vol. 3, 2010 • 51
• Vol. 4, 2017 • 50
SUPPORTING PHARMACOPEIAL PUBLICATION
VOLUME MONOGRAPHS
Thin Layer API Drugs Pt. 1, Vol. 1, 80
Chromatography (TLC) 2009 99
Atlas API Drugs Pt. 1, Vol. 3,
2016
Macroscopy and API Drugs Pt.-1, Vol. 5, 92
Microscopy Atlas 2009 80
API Drugs Pt.-1, Vol. 1,
2011
CONCLUSION
• In India, the development of the Indian pharmacopoeia started in 20th
Century on the recommendation of the Col. R.N. Chopra committee and
in 1978 the first part of the Ayurvedic formulary of India was published.
Subsequently, the amendment in the drugs and cosmetics act 1940
was brought in 1964 for regulation of the drugs in Indian Systems of
Medicine (Ayurveda, Unani and Siddha). Later on the Ayurvedic
Pharmacopoeia of India (Mono-Monographs) Part-1,Volume-1,was
published in the year 1989 and the other volumes were published
subsequently in different year.