Volume 167, 5 June 2015, Pages 108–114
Potent Substances: On the Boundaries of Food and Medicine
- Padma AG, Unterfeldstrasse 1, 8340 Hinwil, Switzerland
- Received 14 April 2014, Revised 23 September 2014, Accepted 19 October 2014, Available online 29 October 2014
Abstract
Ethnopharmacological relevance
The
increasing prevalence of complex multi-factorial chronic diseases and
multimorbidity reveals the need for an enlargement of the therapeutic
options. Potent multicompound herbal formulations from traditional
medicine systems such as Tibetan Medicine might meet the requirements.
With its practice over the centuries Tibetan Medicine is one of the
important medical heritages of the world. In the 20th century Tibetan
formulas came to Switzerland, where the formula Gabur-25 was then
registered as medicine in 1977 (Padma 28, Swissmedic No 35872). The new
European directive 2004/24/EC opened the avenue for traditional herbal
medicinal products and registrations followed in Austria (HERB-00037)
and the UK (39568/0001). The aim of this review was to analyse not only
the critical points and hazards but also chances that occur in the
endeavour of bringing a ethnopharmacological based preparation to the
market within a modern Western medical and regulatory framework and to
discuss the necessary transformation steps from a traditional herbal
formula towards a modern pharmaceutical product with the example of the
Tibetan formula Gabur-25.
Methods
The
historic transformation process from the 19th to the 21st century is
analysed, using the registration documents and other material from the
library of Padma AG, Hinwil, Switzerland.
Results
The
transformation of a traditional formula into a modern traditional
herbal medicinal product according to the present EU regulations is a
multi faceted process. The modern indication represents only a small
part of the possible traditional indications. Quality and product
labelling has to be adopted to modern standards. The formula, once
registered, is a fixed combination of herbal and mineral ingredients.
Contrary to this the concept of Asian medical tradition allows a certain
flexibility in the composition of an herbal formula. The ingredients
are constantly adapted to local conditions, availability of raw material
and therapeutic situation.
Conclusions
The
example shows that in principle complex herbal formulas from Asian
medicine can meet the requirements of the European regime of traditional
herbal medicinal products. A structured process of transformation from a
traditional herbal formula to a modern medicinal product has to include
selection of a suitable formula, development of an analytic concept and
selection of a suitable indication with regard to the empirical set of
possible indications. To extend the range of high quality medicinal
products from other medical traditions within the European context the
European legislators have to re-evaluate the imposed restrictions given
in directive 2004/24/EC. Without amendment of the prerequisite of 15
years documented use in the EU and the limitation of indications for
traditional herbal medicinal products, European citizens will be
excluded from access to high quality medical traditions with their
accumulated empirical knowledge.
Graphical abstract
Keywords
- Traditional Herbal Registration (THR);
- Traditional herbal medicinal product (THMP);
- Tibetan Medicine;
- Complementary and Alternative Medicine (CAM);
- Padma Circosan;
- Regulatory affairs
Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
