WHO comparative study of Ayurvedic

1. 1.6 Comparative Study of Ayurvedic
Pharmacopoeia of India and WHO guidelines for
herbal medicinal products

2. WHO guidelines for herbal medicinal products
The objectives of these guidelines are to provide:
• Guiding principles for assessing the quality in relation to the
safety of herbal medicines, with specific reference to
contaminants and residues.
• Model criteria for use in identifying possible contaminants
and residues.
• Examples of methods and techniques; and
• Examples of practical technical procedures for controlling
the quality of finished herbal products.

3. WHO guidelines to ensure the quality of herbal drugs
with modern techniques
Monograph guidelines
1. Monograph title
A) Botanical
a)Sensory evaluation
b) Foreign matter----(should free from it if possible)
c)Microscopy
B)Physio-chemical
a)TLC
b)Ash value----total, acid-insoluble, water-soluble
c)Extractive matter---in hot water, cold water, ethanol
d)Water content and volatile matter----LOD
e)Volatile oil---steam distillation

4. C) Pharmacological
a) Bitterness value---units equal to the bitterness of std.
solution of quinine hydrochloride
b)Hemolytic activity----on Ox blood by comparison with std.
reference saponin
c) Astringency---Fraction(tannin)that binds to std. hide
powder
d)Swelling index---in water
e) Foaming index---foam height produced by 1 gm material
under specified conditions.

5. D. Toxicological:
a) Pesticide residue---Chlorides, phosphorus estimation
b)Arsenic---Stain produced on HgBr2 paper in comparison to std. stain
c) Heavy metals---Mercury, Cadmium, lead
E. Microbial contamination:
a)Total viable aerobic count
Pathogen: E.coli, salmonella, P. aerogenosa, S.aures
Aflatoxins: By TLC , Aflatoxins (B1,B2, G1, G2) mixtures----totally free
F. Radioactive contamination:
As per recommendations of the International Atomic Energy Agency
(IAEA)

6. • For the purpose of quality control of herbal drugs, the World
Health Organization (WHO) has prepared the guidelines.
• The objective of the guidelines involves general test
methods and also the general limits for contaminants in
herbal drugs.
• A typical monograph for herbal drugs as per WHO
Guidelines is as follows:

7. Monograph for herbal drugs as per WHO guidelines
Monograph title Parameters Types
Sensory evaluation Visual/ Macroscopy/
Touch/ Taste/
Odour/Size/ Colour
Botanical Foreign matters Foreign plants,
animals, minerals (soil,
stones, sand and dust)
Microscopy Histological
observation, detection,
measurement of
specimens, etc

8. Monograph title Parameters Types
TLC Ascending technique,
horizontal technique,
etc.
Ash Total, acid insoluble,
water-soluble
Physiochemical Microscopy Histological
observation, detection,
measurement of
specimens, etc.
Extractable matter Hot water, cold water,
and ethanol
Water content and
volatile matter
LOD, Azeotropic

9. Monograph title Parameters Types
Bitterness value Units equal to the
bitterness of standard
solution of Quinine
hydrochloride
Hemolytic activity On Ox blood by
comparison with
standard saponin
Pharmacological Astringency Fraction (Tannins) that
binds to standard hide
powder
Swelling index In water
Foaming index Foam height produced

10. Monograph title Parameters Types
Pesticide residue Total organic chloride and
total organic Phosphorus
Toxicological Arsenic Stain produced on HgBr2
paper in comparison to
standard stain
Heavy metals Cadmium and Lead
Microbial contamination Aerobic count pathogen Enterobacteriaceae -
Escherichia coli,
Salmonella,
Staphylococcus,
Pseudomonas
Aflatoxins TLC using standard
Aflatoxins (B;, Bz, G;, G2)

11. Monograph title Parameters Types
Radioactive
contamination
Various radiation
sources
• Microbial growth in
herbals can be
avoided by
irradiation.
• Nature and the
intensity of
irradiation depend
on the source.
• The radioactivity of
the plant samples
should be checked
according to the

12. The Ayurvedic Pharmacopoeia of India (API)
• The Ayurvedic Pharmacopoeia of India (API) is a unique book of
standards describing the quality, purity, and strength of selected drugs
that are manufactured, distributed, and sold by licensed manufacturers
in pan India.
• It is developed in two parts; part one comprises monographs of
medicinal substances of natural origin.
• Part two includes selected compound formulations sourced from the
Schedule - I books under the Drugs and Cosmetics Act, of 1940
comprising popular Ayurvedic classics of different periods of time.
• The first part of the Ayurvedic Formulary of India was published in
1978 and thereafter, the Ayurvedic Pharmacopoeia of India (mono-
monograph) Part-I, Vol. I was published in the year 1989.
• Subsequently, the other volumes were published with their legalized
status under the Drugs and Cosmetics Act, of 1940.

13. ➤ API is the book of standards for single drugs and their
formulations
➤ Published by the Ministry of Ayush.
➤ Description of every single drug or preparation included in
it is called a monograph.
➤ There are 645 monographs in part - 1 and 202
monographs in part - 2

14. A TYPICAL MONOGRAPH OF API
• TITLE
• NAME OF MONOGRAPΗ
• SYNONYMS
• DESCRIPTION (MACROSCOPIC & MICROSCOPIC)
• IDENTITY, PURITY AND STRENGTH
• FOREIGN MATTER
• TOTAL ASH
• ACID-INSOLUBLE ASH

15. Contd…
• ALCOHOL SOLUBLE EXTRACTIVE
• WATER SOLUBLE EXTRACTIVE
• ASSAYS AND TESTS
• CONSTITUENTS
• PROPERTIES AND ACTION
• IMPORTANT FORMULATIONS
• THERAPEUTIC USES
• DOSE

16. Parameters of quality
control and
standardization
1. Identity of the drug
2. Physical parameters
3. Chemical parameters
4. Pharmacological
parameters
5. Toxicity

17. 1. Identity of the
Drug
 Sensory Evaluation
 Botanical Evaluation
 Macroscopic &
Microscopic
evaluation
 Histological analysis
• Systematic Study of Crude
Drugs
• Microscopic methods of
examining crude Vegetable
drugs
• Types of Stomata
• Determination of Stomatal
Index
• Determination of Palisade
Ratio
• Determination of Vein -Islet
Number
• Determination of Stomatal
Number

18. 2. Physical parameters
• Determination of Foreign
matter
• Determination of Moisture
content
• Determination of Total ash
• Determination of Acid
Insoluble Ash
• Determination of Water
soluble Ash
• Determination of Alcohol
soluble extractive
• Determination of Water-
soluble extractive

19. 3. Chemical Parameters
-Quantitative
-Qualitative
-Chromatographic
Analyses
• Starch estimation
• Sugar estimation
• Determination of acidity
• Protein estimation
• Alkaloid estimation
• Determination of ester
• Fixed oil content
• Volatile oil
• Continuous extraction of
drugs

20. 4. Pharmacological
parameters
• Bitterness value
• Hemolytic value
• Astringency
• Swelling factor
• Foaming index

21. 5. Toxicity details
(limit tests)
• Limit Test for Arsenic
• Limit Test for Chlorides
• Limit Test for Heavy Metals
• Limit Test for Iron
• Limit Test for Lead
• Limit Test for Sulphates
• Heavy Metals by Atomic Absorption
Spectrophotometry
• Determination of Lead, Cadmium,
Arsenic, Mercury and Copper
• Determination of Calcium Oxide
• Microbial Limit Tests
Total Aerobic Microbial Count
Tests for Specified Micro-Organisms

22. Comparative Study(Ayurvedic Pharmacopoeia &WHO guidelines for herbal
products)
WHO guidelines Ayurvedic pharmacopoeia
Identity of the herbal drug Sensory evaluation (Visual,
macroscopy,
taste, odor, size, color)
Foreign matter, animals'
minerals
(soil, stones, sand dust) and
Histological observations.
Sensory evaluation, Botanical
evaluation, macroscopy,
microscopy, and histological
analysis.
Physiochemical parameters TLC, Ash value, Microscopy,
extractable matter, water
content and volatile matter,
volatile oil content
Ash value, extractive value,
moisture content, foreign
matter,
Alkaloid estimation, fixed oil
content, starch estimation,
volatile oil, continuous

23. Contd…
WHO guidelines Ayurvedic Pharmacopoeia
Pharmacological parameters Bitterness value, Hemolytic
activity, Astringency, Swelling
index, Foaming index
Bitterness value, Hemolytic
value, Astringency, Swelling
factor, Foaming index
Toxicological parameters Pesticide residue, Arsenic,
Heavy metals
Limit test for Arsenic,
chlorides, heavy metals, iron,
lead, sulfates, Determination
of lead, arsenic, mercury and
copper, determination of
calcium oxide

24. Contd…
WHO guidelines Ayurvedic pharmacopoeia
Microbial contamination Aerobic count pathogens
Enterobacteriaceae(E.Coli,
Salmonella, staphylococcus,
Pseudomonas)
Aflatoxins(TLC using standard
aflatoxins, B,Bz, G, G2)
Total aerobic microbial count
Tests for specified micro-
organisms
Radioactive contamination Microbial growth can be
avoided by irradiation.
International Atomic Energy
Agency(IAEA)guidelines check
for radioactivity in the plant
samples.
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25. Thank You!