Herbal medicines
Directive is impossible in practice
From Dr R. J. Woodward, MRPharmS
It is nonsense for the Medicines Control Agency to claim that the effect
on industry of the proposed herbal directive will be minimal (PJ, 19 October,
p560).
The excellent reports of the International Pharmaceutical Federation meetings
on 4 September (PJ, 21 September, p403) put the herbal medicines problems
and difficulties into practical perspective. Linda Anderson’s reference
to harmonisation of requirements for safety, quality and efficacy resulting
from adoption of the directive is something of a pipe dream when we learn
of the complexity of herbal ingredients and products. Dr Lang (p405) tells
us that of the six best documented products one is kava. Then there are
the 2,000 component herbal product mixtures. The substantial differences
in release patterns of ingredients from hard and soft gelatin capsules
are unbelievable. Few comprehensive monographs and consistent specifications
are available.
Surely this is enough for the regulators to realise that although a directive
may be desirable to satisfy their yearn for control, what is currently
on offer is impossible in practice. The industry does not have either
the financial resources or skills to meet the technical demands envisaged
in the directive. Indeed, many would argue that the inherent variability
of herbs make such demands unachievable. Equally, regulatory resources,
even if the manpower and skills were available, to police such a directive
properly would be vast and poor value for the consumer.
In the present state of knowledge, the only practical way forward is
to introduce a registration system including a negative list, good manufacturing
practice and realistic purity standards to detect adulteration and known
trace toxic contaminants. Claims should be based on traditional use backed
with labelling and promotional caveats.
Such a system would establish a level playing field for
marketers and manufacturers whereas what is currently proposed is potentially
a charter for the less scrupulous elements on both sides.
Robert Woodward
Liss, Hampshire
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