WHO guidelines provide criteria for assessing quality, safety, and efficacy of herbal medicines. Key steps include authentication of plant materials, testing for contaminants like heavy metals and microbes, and ensuring consistency of finished products through identification of active constituents. Quality is evaluated through parameters like microbial limits, extractive values, and chromatography. Safety assessment considers traditional use and toxicology studies. Efficacy depends on intended use and documentation of traditional experience or medical history. Proper identification, manufacturing, and stability testing help ensure herbal medicines meet quality standards.

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WHO GUIDELINES IN QUALITY
ASSESSMENT OF HERBAL DRUGS
Dr Prasanth B
HOD , Pharmacognosy
St James’ College of Pharmaceutical Sciences, Chalakudy

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Contents:
 Introduction
 Objective
 Assessment of
Quality
Safety
Efficacy
Intended use
 Product information for the consumer
 Utilization of guidelines
 Conclusion

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Introduction:
For the purpose of these guidelines “Herbal medicine” should be regarded as :
 Finished,labelled medicinal products that ,contain as
active ingredient aerial or underground parts of plants,
or other plant material or combinations there of, whether
in the crude state or as plant preparations
 Plant material include juices, gums, fatty oils, essential
oils and any other substances of this nature.Herbal
medicines may contain excipients in addition to the
active ingredients.
 Medicines containing plant material combined with
chemically defined,isolated constituents of plants, are
not considered to be herbal medicine.

4.  Exceptionally, in some countries herbal medicines may also
contain, by tradition, natural organic or inorganic active
ingredients which are not of plant origin.
 The past decade has seen a significant increase in the use of
herbal medicines. As a result of WHO’s promotion of traditional
medicines , countries have been seeking the assistance of WHO
in identifying safe and effective herbal medicines for use in
national health care system.
 In both developed and developing countries, consumers and
health care providers need to be supplied with up-to-date and
authoritative information on the beneficial properties and
possible harm full effects ,of all herbal medicines.

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Objective:
 To define basic criteria for the evaluation of quality,safety and efficacy of
herbal medicines and there by to assist national regulatory
authorities,scientific organisations and manufacturers to under take an
assessment of the documentation or submission in respect of such products.
 As a general rule in this assessment, traditional experience means long term
use as well as the medical, historical and ethonological background of those
products shall be taken.

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Assessment of Quality,Safety and Efficacy and Intended use:
Pharmaceutical assessment:
 This part should cover all important aspects of the quality assessment of herbal
medicines.However,if a pharmacopoeia monograph exists it should be sufficient
to make reference to this monograph. If no such monograph is avaliable, a
monograph must be supplied and should be set out in the same way as in an
official pharmacopoeia.
 All procedures should be in accordance with Good Manufacturing Practices
[GMP].
Crude plant material:
 The botanical definition,including genus,species and authority should be given
to ensure correct identification of a plant.A definition and description of the
part of the plant from which the medicine is made(eg;leaf,flower,root) has to
be provided as well as an indication as to whether fresh, dried or traditionally
processed material is used.

7. The active and characteristics constituents should be specified
and if,possible, content limits should be defined.
Foriegn matter,impurities and microbial content should be
defined or limited.
Voucher specimen,representing each lot of plant material
processed,should be authenticated by a qualified botanist and
should be store for at least a ten year period.
A lot number should be assigned and this should appear on the
product label.

8. WHO documents and publications relating to the quality assurance of
herbal medicines with regard to safety should include the following steps:
1. Authentication (Stage of collection, parts of the plant collected, regional
status, botanical identity like phytomorphology, microscopical and
histological analysis, taxonomical identity, etc.)
2. Foreign matter (herbs collected should be free from soil, insect parts or
animal excreta, etc.)
3. Organoleptic evaluation (sensory characters – taste, appearance, odor,
feel of the drug, etc.)
4. Tissues of diagnostic importance present in the drug powder.
5. Ash values and extractive values.
6. Volatile matter
7. Moisture content determination

9. 8. Chromatographic and spectroscopic evaluation. TLC, HPTLC,
HPLC methods will provide qualitative and semi quantitative
information about the main active constituents present in the crude
drug as chemical markers in the TLC fingerprint evaluation of herbals
(FEH). The quality of the drug can also be assessed on the basis of the
chromatographic fingerprint.
9. Determination of heavy metals – e.g. cadmium, lead, arsenic, etc.
10. Pesticide residue – WHO and FAO (Food and Agricultural
Organization) set limits of pesticides, which are usually present in the
herbs. These pesticides are mixed with the herbs during the time of
cultivation. Mainly pesticides like DDT, BHC, toxaphene, aldrin
cause serious side-effects in human beings if the crude drugs are
mixed with these agents.

10. 11. Microbial contamination – usually medicinal plants containing
bacteria and molds are coming from soil and atmosphere. Analysis of
the limits of E. coli and molds clearly throws light towards the
harvesting and production practices. The substance known as
afflatoxins will produce serious side-effects if consumed along with the
crude drugs. Afflatoxins should be completely removed or should not
be present.

11. Microbial tests should be applied to starting plant materials,
intermediate and fi nished products where necessary.
Enterobacteria and certain other Gram-negative bacteria
Escherichia coli, Salmonella and Staphylococcus aureus are
included as target strains of the test. The conditions of the tests for
microbial contamination are designed to minimize accidental
contamination of the materials being examined and the precautions
taken must not adversely affect any microorganisms that could be
revealed.

12. 12. Radioactive contamination – Microbial growth in herbals are
usually avoided by irradiation. This process may sterilize the plant
material but the radioactivity hazard should be taken into account. The
radioactivity of the plant samples should be checked accordingly to
the guidelines of International Atomic Energy (IAE) in Vienna and
that of WHO

13. The quality of the raw materials can be tested according to the following
format:
• Name of the drug (English, Regional names, Exact botanical
nomenclature)
• 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 (fresh or dry)
• Form of the drug (powdered or intact or cuttings like etc.

14. In order to obtain quality oriented herbal products care should be taken
right from the proper identification of plants; season and area of
collection, extraction, isolation and verification process.
Chemical and instrumental analyses are routinely used for analyzing
synthetic drugs to confirm its authenticity

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Plant Preparations:
Plant preparation should include powdered plant materials, extracts,tintures,fatty
or essential oils,expressed juices and preparations whose production involves a
fractionation, purification or concentration process.The manufacturing process
should be described in detail.If any other substance is added during the
manufacture,to adjust the plant preparation to a certain level of active or
characteristic constituents or for any other purpose,the added substsnce should be
mentioned in the procedure description.
A method for identification, and where possible assay of plant preparation
should be added.If the identification of an active principle is not possible,it
should be sufficient to identify a characteristic substance or mixture of
substances (eg;chromatographic fingerprint) to ensure consistent quality of
preparation

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Finished products:
 However the scene is different especially for polyherbal formulation, as
there is no chemical or analytical methods available.
 The herbal formulations in general can be standardized schematically as
to formulate the medicament using raw materials collected from
different localities and a comparative chemical efficacy of different
batches of formulation are to be observed.
 The preparation with better clinical efficacy are to be selected. After all
the routine physical, chemical and pharmacological parameters are to
be checked for all the batches to select the final finished product and to
validate the whole manufacturing process.
 The manufacturing procedure and formula including the amount of
excipients should be described in detail.

17.  A method of identification,and where possible quantification,of
the plant material in the finished product should be defined.
 If the identification of an active principle is not possible,it
should be sufficient to identify a characteristic substsance or
mixture of substance (eg,chromatographic fingerprinting) to
ensure consistent quality of the product.
 For important finished produts,confirmation of regulatory
status in the country of the origin should be required;the WHO
certification scheme on the quality of the pharmaceutical
products moving in International Commerce should be
applied.

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Stability:
 The physicsal and chemical stability of the product in the final marketing
container should be tested under defined storage conditions and the
shelf-life should be established.
Safety assessment:
 This part should cover all the relavent aspects of the safety assessment of
a medicinal product has been traditionally used with out demonstrated
harm and no specific restrictive regulatory action should be undertaken
unless new evidence demands a revised risk-benefit assessment.
Toxicological studies:
 If any toxicological studies are available, they should be part of the
assessment.If a toxicological risk is known, toxicity data have to be
submited.Risk assessment, whether it is independent of dose (eg,special
danger allergies) ,or whether it is a function of dose should be
documented.

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Assessment of Efficacy and Intended use:
 This part should cover all the important aspects of efficacy assessment. A
review of the relavent literature should be carried out and copies provided of
the original articles or proper references to them.
Activity:
 The pharmocological and clinical effects of the active ingredients and,if
known,their constituents with therapeutic activity shoud be specified or
described.
Evidence required to support indications:
 The indications for the use of medicine should be specified.In the case of
traditional medicines,the requrements for proof of efficacy shall depend
on the kind of indication.

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Combination products:
 As many herbal remedies consist of a combination of several active
ingredients, and as experience on the use of traditional remedies is often
based on he combination of products. In assessment there should be
differentiation between old and new combinations products. Identical
requrements for the assessment of old and new combinations would result in
an appropriate assessment of certain traditional medicines.
 In the case of traditionally used combination products,the documentation of
traditional use and experience may serve for documentation of efficacy.
 In ordeer to justify the efficacy of a new ingredient and its positive effect on
the total combination,clinical studies may be reqired.

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Product Information for the Consumer:
 The labelling of the products and the package insert should be understandable
to the consumer/patient. The package informstion should cover all necessary
information on the proper use of product. The following elements of
information usually suffice:
 Name of the product
 Quantitave list of active ingredient
 Dosage form
 Indications
- Dosage (if appropriate,specified for children and the elderly)
- Mode of administration
- Duration of use
- Major adverse effects,if any
- Over dosage information
- Contraindication,warnings,precautions and major drug indications
- Use during pregnancy and lactation
- Expiry date
- Lot number
- Holder of the marketing authorisation

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 Identification of the active ingredient by the latin botanical name,in addition
to the common name in the language of preference of national regulatory
authority is recommended.
Promotion:
 Advertisements and other promotional activities to health personnel and
the lay public should be fully consistent with the approved package
information.
Utilization of guidelines:
 WHO guidelines for the assessment of herbal medicines are intended to
facilitate the work to a carried out by regulatory authority, scientific bodies
and industry in the development , and assessment and registration of such
products.
 The effective regulation and control of herbal medicines moving in
international commerce also require close liaison with appropriate national
institutions that are able to keep under regular review all aspects of their
production and use , as well as to conduct or sponser evaluative studies of
their efficacy,toxicity,safety,acceptability, cost and relative value compared
with other drugs used in modern medicine.

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Conclusion:
All the Herbal based industries should meet specification and
requirements of herbal drugs and formulations as per the WHO guidelines to
attain the quality,safety and efficacy.

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References:
GUIDELINES FOR THE ASSESSMENT OF HERBALMEDICINES
[Programme on traditional medicines WHO Geneva,1991]

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