WHO Guidelines for Quality control(Standardization) of Herbal preparations 2011

Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that
herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of
them are very toxic. However, the adverse effects of phytotherapeutic agents are less frequent compared with
synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several
regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter
substances, traditional medicines and dietary supplements.

25% of prescribed medicine contain ingredients from medicinal plants.80% of world populations still relies on
herbal medicines and the demand is at increased rate.Herbal medicine will only benefit the health of human
beings when they are used appropriately, thus good quality control and standardization of herbal medicines is
essential. Medicinal plants have been used since ancient times for the treatment of human ailments. Interest
in medicinal plants has been shown throughout the world because of the safe and effective constituents
of plant products. The increasing demand for herbal medicines, both in the developing and developed countries,
has provided the stimulus for the workers in this field to maintain the quality and purity of their herbal raw
materials and finished products. The standardization problem relating to herbal drugs arises from the complex
composition of drugs that are used in the form of whole plants, plant parts or extracts obtained there from. To
ensure reproducible quality of any herbal remedy, proper control of starting material is utmost
essential.Furthermore with the increased use of both herbal medicines & modern western pharmaceutical drugs,
there is a need to monitor interactions. Standardization of drug means confirmation of its identity and
determination of its quality and purity. The authenticity of a crude drug is established by comparison of the
standards given in the pharmacopoeia or other official publication of the country concerned. Biochemical &
geographical variation, deterioration and adulteration need herbal drug standardization.

Generally four principles are considered during standardization procedurea.Quality control of crude drugs
material, plant preparations and finished products.
b.Stability assessment and shelf life.
c.Safety assessment; documentation of safety based on experience or toxicological studies.
d. Assessment of efficacy by ethnomedical informations and biological activity evaluations.

The standardization of crude drug materials include the following steps:

a.Reference to the identity of the drug.

 Botanical evaluation – Stage of collection, parts of the plant collected, regional status
 Botanical identity like phytomorphology, microscopical and histological analysis

 leaf constants(Stomata number,stomatal index,veini-slet number,veinlet termination number)

 taxonomical identity

 Sensory characters(taste, appearance, odor, feel)

 foreign organic matter

 quantitative measurements

b.Reference to the physiochemical character of the drug. Chromatographic profiles, ash values, extractive
values, refractive index, polarimetric readings, moisture content, volatile oil content, total secondary metabolite
content(alkaloid,tannins,flavonoids), viscosity, pH, disintegration time, friability, hardness, flowability,
flocculation, sedimentation, settling rate ,bulk density,carr index,hausners ratio etc.
WHO Guidelines for Quality control(Standardization) of Herbal preparations 2011
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.

In case of fixed oils certain parameters are studied:Saponification value,Iodine value,Ester value and Acid value

c.Reference to the pharmacological parameters. Biological activity profiles, bitterness values, haemolytic
index, astringency, swelling factor, foaming index, etc.

d.Toxicity details – heavy metals like cadmium, lead, arsenic, mercury, etc.

e.Microbial contamination – Usually medicinal plants containing bacteria and molds are coming from soil and
atmosphere. The substance known as afflatoxins will produce serious side-effects if consumed along with the
crude drugs.The presence of aflatoxins can be determined by chromatographic methods using standard
aflatoxins B1, B2, G1, G2 mixtures. Aflatoxin is a product of the microbial strain Aspergillus flavus.Afflatoxins
should be completely removed or should not be present.

Limits for Microbial Contamination(per gm)

Microorganism Finished product Raw materials

E. coli 101 104

Salmonella - -

Total aerobic bacteria 105 -

Enterobacteria 103 -

f) 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.

g) 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.