Traditional Medicine in Asia

Traditional Medicine in Asia
evaluating the safety and efficacy of herbal
medicines.
Terminology and scope of
regulatory control
Some national drug laws refer specifically
to medicinal plants and/or herbal
remedies, but there is no consistency in the
terminology employed to identify or
describe them for regulatory purposes. In
the international sphere, only the Single
Convention on Narcotic Drugs, 1961, as
amended by the Protocol of 1972, which
is concerned only with a limited number of
plant substances, and particularly those with
some therapeutic value and a high potential
for abuse offers precise definitions.
In a more general context, the 1965
EEC Directive on Medicinal Productsd lends
precision to general definitions. The word
“substance” is defined as applying to any
matter “irrespective of origin”. “Vegetable
substance” is established as a general
definition that comprises “plants” and
“parts of plants”.
Some national laws subsume medicinal
plants into the definition of “substance” (e.g.,
the Netherlands); “medicament” (e.g.,
China); “traditional drug” (e.g., Indonesia),
“herb” (e.g., Rep. of Korea), “herbal remedy”
(e.g., United Kingdom); “traditional medicine
(e.g., Singapore); or “herbal substance”
(e.g., Australia).
In some countries, medicinal plants are
embraced within national drug legislation
by virtue of being listed in a pharmacopoeia
(e.g., France) or in a national formulary
(e.g., the Philippines).
The term “herbal remedy” is similarly
subjected to a variety of legal definitions.
In the Medicines Act, 1968, of the United
Kingdom, “herbal remedy” has been
defined as
d Council Directive 65/65/EEC of 26th January 1965, as subsequently amended.
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“a medicinal product consisting of a
substance produced by subjecting a plant
or plants of drying, crushing or any other
process or of a mixture whose sole
ingredients are two or more substances
so produced, or of a mixture whose sole
ingredients are one or more substances
so produced with water or some other
inert substance”.
The Australian Therapeutic Goods
Regulations, 1990, has a broader
definition of herbal substance:
“all or part of a plant or substance
(other than a pure chemical or a
substances of bacterial origin): (a) that is
obtained only by drying, crushing, distilling,
extracting, expressing, comminuting,
mixing with an inert diluent substance or
another herbal substance or mixing with
water, ethanol, glycerol or aqueous ethanol;
and (b) that is not subjected to any other
treatment or process other than a treatment
or process that is necessary for its
presentation in a pharmaceutical form”.
The WHO guidelines for the assessment
of herbal medicines propose a
definition which is subsidiary to the term
“plant preparation”:
“Finished, labelled medicinal products
that contain as active ingredients aerial
or underground parts of plants, or other
plant material or combination thereof,
whether in the crude state or as plant
preparations. Plant material includes
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 active
substances, including chemically defined,
isolated constituents of plants, are not
considered to be herbal medicines.”