The Pharmaceutical Journal
Vol 268 No 7199 p717-719
25 May 2002

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  Dispensing
  Checking technicians
  Childhood vaccination
  NHS Direct
  Concordance
  Herbal remedies
  Disease mongering
  Honorary auditors
  Modernisation
  The Society

Letters to the Editor

Herbal remedies

MCA has thrown down gauntlet to herbal people

From Dr R. J. Woodward, MRPharmS

So, the Medicines Control Agency has thrown down the gauntlet to the herbal people at last (PJ, 18 May, p674). The questions it asks are plausible, too. No reasonable person could possibly take exception to them could they? The problem is that the MCA is being disingenuous. There are indeed a few small manufacturers meeting its demands but I doubt they are many or their ranges great.

MCA rules decimated the medicinal herbal product list of thousands throughout the 1970s, '80s and '90s. Efficacy may have been seen as the main reason for this, but it was not. The real problem was with the chemical and pharmaceutical aspects that are at the forefront of the present impasse. I was then working in industry and we lost hundreds of products because consistently meeting tight specifications of the type demanded by the inspectors and regulators at the MCA was impossible in the real world for most herbal ingredients. We had to set such standards but it was often impossible to meet them batch to batch. We were constantly out of stock of ingredients and with herbal combinations, which most products were, just one ingredient not up to specification could wipe out several items.

When we asked the MCA for a variation it would demand full validation of the ingredient and all combination products involved. Increasing the content to adjust for the shortfall was not permitted. If the currently available ingredient was below strength on the markers then, perhaps rightly but totally without appreciation of the practical situation, the MCA wanted to know what constituents had increased in strength and an assessment of the consequent dangers. Unsurprisingly we had other things to do to keep our staff and business going. In addition, our qualified persons were all castigated for daring to exercise their professional discretion when dealing with herbal products.

The oxymoron of wide and flexible specifications is a non-starter for the MCA and yet what else can a natural product have when climate and soil are major determinants of pharmaceutical and chemical quality?

I wish the interest groups luck in their negotiations to prevent the next decimation but reassuring words from the bureaucrats should be totally discounted. I believe the German herbal manufacturers have managed to maintain their ranges despite their regulators — perhaps our groups should find out how they did it and what they think about the proposed directive.

Robert Woodward
Liss, Hampshire

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