INDICES> Registration of herbal drugs

[netcp <netcp@isb.apollo.net.pk>]

INDICES> Registration of herbal drugs
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[please note the same topic is also discussed in E-drug; WB]

Several herbal products are available in the market in Pakistan. Since
there is no herbal drug law in the country these drugs are freely
marketed and aggressively advertised with little appreciation of the
fact that these can be harmful. This lack of knowledge and apathy exists
at all levels.

But there is another trend here. Manufacturers and importers of herbal
medicines and other medicines of unproven efficacy and safety try their
level best to get their products registered under the Drugs Act, 1976
(the law is only for Allopathic medicines). One may ask that why they
are interested to get their products under regulation! The answer is
that they want the stamp of approval from Drug Registration Board which
(in theory) would mean that DRB has assessed the efficacy, safety and
quality of these preparations and has found them of acceptable. Then
they sell this "acceptability" to the medical profession and to the
consumers. Medical doctors feel less hesitant to prescribe the
registered products than unregistered ones and companies can always find
"specialists" who can sell their patronage for these products. A number
of such products have been registered in Pakistan. Just to give two
examples: Ginseng under various names and combinations has been
registered and Solcoseryl (extract of calf blood) preparations have
approval of DRB under various forms. Both of these are expensive
preparations and are liberally prescribed by the doctors.

We want to prepare a report on these kinds of questionable registrations
and submit to the government for action. But before that we want to know
the practice in other countries and how the issue has been addressed
elsewhere and with what kind of results.

Any information about the registration status of the above mentioned
drugs in other countries would also be appreciated.


Dr Zafar Mirza
Pakistan
Email: netcp@isb.apollo.net.pk

[moderator's comment: WHO/EDM in Geneva has a Traditional Medicine unit that has published
several publications on the assessment of efficacy, safety, control and registration
of herbal medicines.

WHO/EDM/TRM/98.1 publication "The Regulatory situation of herbal medicines" is
downloadable on the WHO/EDM website at:
http://www.who.int/medicines/docs/Pagespublications/Traditionalpub.htm

More publications of WHO/EDM are becoming online available: go to the general website
http://www.who.int/medicines
and follow links to Information, then publications, then EDM library

Wilbert Bannenberg, INDICES moderator (also WHO/EDM staffer)]
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