Issue 12 - amam-ayurveda.org

Nandita Vijay, Bengaluru, Friday, December 30, 2011, 08:00 Hrs [IST]
info Ayurveda, Volume 1, No.12, April-June’ 2012
European Pharmacopoeia commences
development of ‘Community Monographs’ for
European Pharmacopoeia and the European Medicine
Agency have commenced the preparation of
‘Community Monographs’ for herbal remedies. To begin
with, the monographs will be made applicable for single
herbs.
The decision to create monographs is driven by
the increasing shift in consumers opting for dietary
supplements and nutraceuticals developed from herbs.
The development of pharmacopoeia monographs would
provide the much-needed information, stated Dr D B
Anantha Narayana, leading scientist in herbal drugs and
plant medicine.
Even the government of India through the Indian
Pharmacopoeia or Ayurveda Pharmacopoeia needs to
take up this. It would be the best way to ensure India gets
its prominent position in the global herbal map. In an age
of growing consumption of herbal nutraceuticals, there
is need for authentic information on products, its usage,
quality, dosage forms and disease indications, he added.
Pharmacopoeia monographs would serve not just for
consumers but is important for physicians and pharmacists.
US Pharmacopoeia (USP) is now primarily a regulatory
quality specifications for all categories of drugs which
can be extended to cover the ‘Dietary Supplements’.
Although, mere presence of a herb in a Pharmacopoeia
does not mean it is approved as a drug, yet its importance
cannot be underestimated. Pharmacopoeia monographs
provide a reference globally for quality specifications
for the authentic identity, content, component quality. It
is an assurance that the product sans contaminants like
microbial, pesticides and heavy metals. The very mention
of a herb in the pharmacopoeia monograph allows easy
trade and reduces rejections in the global market. It is
herbal remedies
also an indication to ensure batch-to-batch consistency
for researchers. While the herb with a monograph can
promote future technology developments, it provides
regulators a confidence on the history of usage and safety
profiles in the large scale production of a product, said Dr
Narayana.
Globally, in the area of traditional knowledge based
treatments, over 90 per cent of the products are botanical
based. Despite the considerable discussions on need for
standardization for herbal products, there has been a rise
of use in herbal botanicals as supplements which do not
come under the category of drugs. But the Pharmacopoeia
experience coming handy has been largely to access the
specifications of the herbs.
Indian Pharmacopoeia 2010 [IP2010] has 89 monographs
for herbs, processed herbs, including for extracts/oils, and
herbal products. USP has over 180 monographs for herbs,
powdered herbs, processed herbs including extracts, oils,
and herbal products. British Pharmacopoeia (BP) has over
50 monographs for herbs, powdered herbs, processed
herbs including extracts, oils, and herbal products.
European Pharmacopoeia (EP) has over 60 monographs
for herbs, powdered herbs, processed herbs including
extracts, oils, and herbal products. Pharmacopoeia of
Republic of China [PRC] has over 180 monographs
for herbs, powdered herbs, processed herbs including
extracts, oils, and herbal products besides being the
one that has quality specifications for large number of
Traditional Chinese medicines (poly herbal).
With international regulators insisting now insisting on
authentic herbs with defined botanical identity India
will need to look at building a ‘Minimum Therapeutic
Guarantee’ basis and establish a natural window of few
compounds and test for the compliance to the window,
pointed out Dr Narayana.
Courtesy: PHARMABIZ.com
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