INTRODUCTION
Medicinal plants are in use for the purpose of treatment of different ailments since centuries. There has been an immense increase in sales of herbal OTC (Over the counter drugs. This is growing to a billion dollar industry. The need for safety and efficacy has also escalated since th...
ABSTRACT
Herbal drugs are being used as medicines from ancient period. The increased use of herb-
al drugs, and concerns over their safety and efficacy have certainly augmented the need of stand-
ardization of these herbal drugs. WHO has set up guidelines for standardization of these drugs,
which are used as a standard by the majority of countries. The standardization includes the exter-
nal (macroscopy/microscopy) as well as internal examination/ash values, extractive values and
many other parameters to identify, authentify and study its chemical composition. Standardiza-
tion of the medicinal plants will ensure indirectly that the plants are conserved for their medici-
nal and nutritive value. Standardization confirms the safety of the medicinal plant but efficacy
has to be judged clinically or in the laboratory. There is a thin line between efficacy and the
presence of chemical compounds in the drug. The major hurdle in standardization of the batch to
batch variation in the plant compounds. Addition of finer analytical methods of the chemical
compounds may help to minimize the variation and give a better resolution of the plant drug.
Importance of toxicological examination has increased manifolds as contamination can occurs at
various stages, from collection, storage, analysis or processing to extraction of active principles.
, Nilakshi Pradhan et al: Who (World Health Organization) Guidelines For Standardization Of Herbal Drugs
These parameters should be recorded for years together; their database should be generated, rec-
orded and analyzed statistically to see the difference in quality and quantity of the chemical
compounds.
Keywords: Standardization, herbal drug, botanical, pharmacological, toxicological, parameters
INTRODUCTION future trends of the methods used for
Medicinal plants are in use for the analysis of the herbal drug.
purpose of treatment of different ailments Thus to overcome these obstacles
since centuries. There has been an immense there are many standards and parameters set
increase in sales of herbal OTC (Over the by different pharmacopeias, but guidelines
counter drugs. This is growing to a billion set by the WHO remain most significant.
dollar industry. The need for safety and Materials and Methods
efficacy has also escalated since the western
BOTANICAL PARAMATERS4-
interest has grown. Thus the need for
standardization has come into view. The Sensory evaluation-Visual macroscopy,
process of evaluation of the quality and purity Colour, Odour, Taste, Fracture are the
of crude drugs by means of various common tests conducted for identification of
parameters like morphological, the crude drug.
microscopical, physical, chemical and Foreign matter-It has to be determined if the
biological observations is called foreign matter is organic (Moulds, Insects,
1
standardization. Standardisation of the herbal Animal excreta etc.) or Inorganic (Stone, soil
drug begins from the collection of the herbal etc).Foreign matter is considered as-
drug to its packaging/use as medicine. The • material not collected from the original
impediments in standardization of herbal plant source (insects, moulds, or other
drugs- animal contamination)
•
Variability in the chemical composition • Parts of the organ, or organs from which
of the soil and changes in the climate in- the drug is derived other than the parts
fluence the range of phyto constituents named in the definition and description.
present in the herbal drugs.2 Methods to determine the foreign organic
• Growing deforestation is leading to matter-
increase in the number of endangered • Manual method
species of medicinal plants. This leads to • Lycopodium spore method
addition of adulterants or substitutes to the
Microscopy-Identification of histological
herbal drug. Addition of adulterants and
characters(under low and high power).Study
substitutes can change the safety and
individual characteristics in all respects
efficacy of the drug. Objectives: The
(Qualitative and Quantitative
present article will review the WHO
measurements).Observe identifying
guidelines for standardization of Herbal
characteristics in few more slides to confirm
Drugs as well as focus on the current and
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