UK to raise quality of herbals

Related tags Herbal medicinal products European union

The UK's medicines watchdog has outlined options for increased
regulation of unlicensed herbal medicines in a new consultation

The proposals could change the structure of ingredients supply to herbal practitioners, raising the quality of available products and even impacting encouraging a greater number of consumers to look to a qualified herbalist rather than buying products off the shelf.

The UK has for many years exempted herbal medicines from a marketing authorisation if they are not produced industrially but made up following a one-to-one consultation by a herbalist. The majority of herbals currently available on the market are in fact unlicensed.

But safety risks to the public from this category of products is likely to grow with increasing use of herbal and alternative medicine.

The Medicines and Healthcare products Regulatory Agency (MHRA) also predicts that the introduction of the proposed EU Directive on Traditional Herbal Medicinal Products, expected to be published in the European Union's Official Journal this month, and other comparable measures in countries such as Canada and Australia, could see those wishing to get rid of low grade unregulated products and ingredients targeting areas of ineffective regulation to off-load their stocks.

Further, the depletion of some species of medicinal plants owing to the worldwide popularity of herbal medicines is likely to increase the incentive for some less scrupulous suppliers to substitute scarce and expensive ingredients with alternatives of lower quality.

The MHRA​ has proposed creating a statutory register of herbalists and tightening up the regulation of the products they use. Proposals could see manufacturers who supply remedies for use by practitioners required to hold a special licence, guaranteeing the control of premises, equipment and processes. This would present a significant impact on any businesses operating to low standards.

The new proposals would also impact manufacturers who have been manufacturing remedies on a large scale for use in practitioner consultations. They would need to substantially reappraise their product strategy, either registering their products with the MHRA or under the new herbals directive.

However the changes also need to be seen in the light of the new Traditional Herbal Medicinal Products directive, expected to be in force in 2005. This European regulation of herbals could mean the public see less need to consult an expert herbalist; on the other hand the higher standing of the UK's herbalist profession and more effective regulation of the products they use may draw some people away from using OTC herbals in favour of consulting expert herbalists for a more customised service, suggests the MHRA.

Either way, it seems unlikely that the government will opt for no action at all. It seems that quality standards will play an increasing role in market share for all ingredient suppliers.

Further information on the proposal is available from the MHRA website. Comments must be received by 7 June.

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