The Pharmaceutical Journal
Vol 268 No 7198 p673-678
18 May 2002

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Medicines Control Agency (www.mca.gov.uk)

MCA challenges interest groups that oppose herbal regulation

Groups that oppose the introduction of quality standards for herbal medicines have been challenged by the Medicines Control Agency to say exactly which standards they oppose and why.

Minimum quality and manufacturing standards have been proposed in a draft European Union directive on traditional herbal medicinal products (PJ, 6 April, p454) and reputable manufacturers have also been pressing for the introduction of standards.

The standards that are being proposed cover proper identification of herbal ingredients, ingredient quality, contaminant levels, and proper manufacturing standards and record keeping.

They are opposed by some interest groups which say that such regulation is inappropriate or inapplicable to herbal medicines.

Taking the view that herbal medicines are genuine medicines that affect the body, the MCA said on 8 May: "[We] would find it most helpful if any interest groups which oppose the introduction of the proposed standards could identify as soon as possible which of the specific quality and manufacturing standards as currently applied to licensed herbal remedies they believe to be unnecessary or inapplicable to traditional herbal remedies — and why" (PDF* 35K).

The Government believes that standards are needed to remove perverse incentives which currently favour companies that do not want to operate to high standards and that this has led to the availability of low grade and dangerous products. The fact that some small and medium sized businesses already meet the proposed standards has not been addressed by those who say that the standards are unrealistic, it says.