Page 43 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

Medicine is prepared strictly in the same way as described in the
literature while incorporating GMP norms for standardization.
Since traditional remedies have short life, increasing their stability
and shelf life, and controlling their batch to batch variation could be
challenging tasks for modern scientists and drug controllers to
justify the beneficial effects of stored formulations.

10.5.2 Classification of herbal medicines (WHO 2003):

Category 1: Indigenous herbal medicines:
This category of herbal medicines is historically used in a local
community or region and is very well known through long usage by
the local population in terms of its composition, treatment and
dosage. Detailed information on this category of Traditional
Medicine (TM), which also includes folk medicines, may or may not
be available. It can be used freely by the local community or in the
local region.

However, if the medicines in this category enter the market or go
beyond the local community or region in the country, they have to
meet the requirements of safety and efficacy laid down in the
national regulations for herbal medicines.

Category 2: Herbal medicines in systems:
Medicines in this category have been used for a long time and are
documented with their special theories and concepts, and accepted
by the countries. For example, Ayurveda and Unani would fall into
this category of TM.

Category 3: Modified herbal medicines:
These are herbal medicines as described above in categories 1 and
2, except that they have been modified in some way–either shape,
or form including dose, dosage form, mode of administration, herbal
medicinal ingredients, methods of preparation and medical
indications. They have to meet the national regulatory
requirements of safety and efficacy of herbal medicines.

Category 4: Imported products with a herbal medicine base:
This category covers all imported herbal medicines including raw
materials and products. Imported herbal medicines must be
registered and marketed in the countries of origin. The safety and
efficacy data have to be submitted to the national authority of the
importing country and need to meet the requirements of safety and
efficacy of regulation of herbal medicines in the recipient country.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 39