Traditional Medicine in Asia

Standardization, preclinical toxicology and clinical evaluation of medicinal plants, including ethical considerations
Inadequate standardization of medicinal
plants, unacceptable preclinical toxicology
studies and inappropriate uncontrolled
and badly designed clinical trials
form the triad of constraining factors which
have held back the use of medicinal plants
for health development and belied the
longstanding hopes that research on
medicinal plants would lead to a host of
new drugs.
Standardization
Standardization,
preclinical toxicology and
clinical evaluation of
medicinal plants, including
ethical considerations
When a medicine is administered to a
patient, the doctor who prescribes the
medicine needs to be certain that the
medicine contains the correct amount of
the right substance and does not contain
any impurities. Only then will the medicine
induce its therapeutic effect and not induce
any toxic effect due perhaps to contaminants.
This is only possible if the herbal
medicine has undergone a process known
as standardization. It is this lack of
standardization of herbal remedies which
acts as a constraint to the use of these
medicines in allopathic hospitals. It is also
one of the constraints preventing an
increase in the export of traditional
medicines from third world countries with
Ranjit Roy Chaudhury
Mandakini Roy Chaudhury
the unique heritage of abundant unlimited
biodiversity. Only if herbal medicines are
well standardized will countries purchase
such medicines. Only if the allopathic
doctors are convinced that every sample
of a herbal drug contains the same amount
of active constituents will they prescribe
such medicines.
The need for proper standardization
has also been recognized by practitioners
of the traditional systems of medicine. At
the 3rd International Congress of
Traditional Asian Medicine held at Mumbai
from 4–9 January, 1990, this point was
repeatedly highlighted by a large number
of participants who did not belong to the
allopathic system. 1 A group of Ayurvedic
research workers stressed the importance
of developing good methods for
standardizing crude extracts, decoctions
and compound formulations which consist
of different ingredients. It was clearly stated
that the technology available at that time,
10 years ago, was not able to develop
suitable quality control criteria for mixtures
and compound preparations.
There are several factors which have
acted as constraints in the development
of appropriate methods for standardizing
herbal medicines. Some of these have
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