WHO Guidelines for Herbal Drug

Standardization

G.Sunny Grace
100809885017
M.Pharm 1/1
CONTENTS
 Introduction
 Standardization of
herbal drugs/products
 Evaluation of herbal
drugs/products
 WHO guidelines
 Conclusion
 References
INTRODUCTION
 In recent years , there has
been great demand for
plant derived products in
developed countries.
 Standardisation is used
to describe all measures,
which are taken during the
manufacturing process and
quality control leading to a
reproducible quality.
 Evaluation of drug means
confirmation of its identity
and determination of its
quality and purity and
detection of its
adulteration.
Standardization of HerBAL DRUGS/PRODUCTS
 Authentication
 Foreign matter
 Organoleptic evaluation
 Tissues of diagnostic importance
present in the drug powder
 Ash values and extractive values
 Volatile matter
 Moisture content determination
 Chromatogaphic and
spectroscopic evaluation
 Determination of heavy metals
 Pesticide residue
 Microbial contamination
 Radioactive contamination
EVALUATION OF HERBAL
DRUGS/PRODUCTS
 Biological parameter
1. Evaluation of adaptogenic activity profile of
herbal preparation.
2. Evaluation of antioxidant activity of herbal
products
3. Evaluation of microbial contamination reduction
on plants through technological process of
decoction and spray dry
4. Evaluation of nitric oxide scavenging activity of
selected medicinal plants used in inflammatory
diseases
5. The lipid peroxidation inhibitory activity
Contd…
 Evaluation of marketed polyherbal antidiabetic
formulations using biomarker charantin
 In vitro and In vivo evaluation of hair growth
potential of shoe flower
 Clinical evaluation to assess the safety and
efficacy of coded herbal “Dysmo-off” Vs allopathic
medicine for treatment of primary dysmenorrhea
 Thermographic Evaluation
 Biochemical Evaluation
 Evaluation of Kutaj-Ghanavati for alkaloidal
principles
 Organoleptic evaluation
Classical evaluation
The quality of raw materials can be tested
according to following format:
 Name of the drug
 Part of the plant used
 Area of collection
 Distribution details
 Season of Crop
 Time and year of collection
 Pesticide and insecticides
 Condition of the drug
 Form of the drug
Who gUidelines
 Quality control of crude drugs material, plant preparations
and finished products: Botanical evaluation- sensory
characters, foreign organic matter, microscopical,
histological etc.
 Stability assessment and shelf-life: Physicochemical
character of drug- Physical and chemical identity,
chromatographic fingerprints, ash values, extractive values,
moisture content, volatile oil and alkaloidal assays etc.
 Safety assessment: Toxicity details- pesticide residues,
heavy metals, microbial contamination pathogens like
E.coli, Salmonella, P.aeroginosa, S.aureus, etc.
 Assessment of efficacy by ethnomedical informations,
pharmacological parameters, biological activity profiles etc.
WHO GUIDELINES FOR GENERAL LIMITS
 Harmful organic matter : Totally free from it
 Innocuous foreign matter : Free from it
 Pesticidal residues, arsenic and heavy metals :
Max residue limits = BW*ADI*Extn factor
Safety factor*100*MDI
Where ADI= Avg daily intake
BW = Body weight
MDI= Mean daily intake of drug

 Afflattoxins: Totally free from it

 Radioactive Contaminants: As per recommendations of
IAEA
•Microbial contamination
CONCLUSION
 The subject of herbal drug standardization is massively wide and
deep. There is so much to know and so much seemingly
contradictory theories on the subject of herbal medicines and its
relationship with human physiology and mental function.

 For the purpose of research work on standardization of herbal

formulations and neutraceuticals a profound knowledge of the
important herbs found in India and widely used in Ayurvedic
formulation is of utmost importance.

 India can emerge as the major country and play the lead role in
production of standardized, therapeutically effective ayurvedic
formulation. India needs to explore the medicinally important
plants. This can be achieved only if the herbal products are
evaluated and analyzed using sophisticated modern techniques of
standardization such as UV-visible, TLC, HPLC, HPTLC, GC-MS,
spectrofluorimetric and other methods.
References
 1.Sagar Bhanu P.S., Zafar R., Panwar R., “Herbal drug standardization”, The Indian Pharmacist, vol.
4(35), May 2005, 2005, pp.19-22.
 2.Patel P.M., Patel N.M., Goyal R.K., “Evaluation of marketed polyherbal antidiabetic formulations
uses biomarker charantin”, The Pharma Review, vol.4 (22), June 2006, pp.113.
 3.Patel P.M., Patel N.M., Goyal R.K., “Quality control of herbal products”, The Indian Pharmacist,
vol.5(45), March 2006, pp.26-30.
 4.Bhutani K.K., “Herbal medicines an enigma and challenge to science and directions for new
initiatives”, Indian Journal of Natural Products, vol.19 (1), March 2003, pp.3-8.
 5.Kokate C.K., Purohit A.P., Gokhale S.B., “Analytical pharmacognosy”, Pharmacognosy, 30th
edition, Feb. 2005, pp.1,99.
 6.Shrikumar S., Maheshwari U., Sughanti A., Ravi T.K., “WHO guidelines for herbal drug
standardization”, 2006.
 7.Ansari S.H., “Standardization of crude drugs”, Essentials of Pharmacognosy, Ist edition, 2005-06,
pp.14, 581.
 8.Gokhale S.B., Surana S.J., “Fluorescence quenching as a tool for identification and quality control
of crude drugs”, Planta indica, vol 2 (3), July 2006, pp.47.
 9.Shaw P.C., Pui-Hat Butt P., “Authentication of Panax species and their adulterants by random
primed polymerase chain reaction”, Planta Medica, vol. 61, 1995, pp.466-469.
 10.Lazarowych N.J., Pekos P., “Use of fingerprinting and marker compounds for identification and
standardization of botanical drugs: Strategies for applying pharmaceutical HPLC analysis to herbal
products”, Drug Information Journal, Vol.32, 1998, pp.497-512.
QUERIES
questions
THANK YOU