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for designing and evaluating the study. as co-investigators/ collaborators/
members of the expert group is desirable for designing and evaluating the
study.

10.5.1 Special Concerns

The AU drugs include herbal and herbo-mineral formulations. The
herbal products can belong to one of the three categories:

1. From the ancient Ayurveda, Unani literature, lot of
information about the use of a plant or its extract, metals, minerals
and animal products have known or the plant may actually be
regularly used by physicians of the traditional systems of medicine
for a number of years and the substance is to be clinically evaluated
for same indication for which it is being used or as has been
described in the texts.

2. When the therapeutic effect not originally described in the
texts of traditional systems, in case of an extract of a plant or a
compound isolated from the plant and any compound formulation
having plants, metals, minerals and animal products as ingredients
has to be clinically evaluated or, the method of preparation is
different, or it was not originally used for a certain indication by
practitioners in that field, it has to be treated as a new substance or
new chemical entity (NCE) and the same type of acute, sub acute
and chronic toxicity data will have to be generated as required by
the regulatory authority for synthetic products before it is cleared
for clinical evaluation.

3. An extract or a compound isolated from a plant and any
compound formulation having plants, metals, minerals and animal
products as ingredients which has never been in use before and has
not ever been mentioned in ancient literature, should be treated as
a new drug, and therefore, should undergo all regulatory
requirements before being evaluated clinically.

During incorporation with GMP rules for standardization, it is
important that plants and AU remedies currently in use or
mentioned in literature of recognized Traditional System of
Medicine is prepared strictly in the same way as described in the
literature. .It is a challenging task for modern scientists and drug
controller to justify the beneficial effects of stored formulations, as
traditional remedies have short life, increasing their stability and
shelf life, and batch to batch variation.
It is important that plants and AU remedies currently in use or
mentioned in literature of recognized Traditional System of

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