Medicines board wants strict checks on all herbal remedies

New regulations governing the sale of herbal medicines have been proposed by the Irish Medicines Board. Under the regulations, manufacturers and wholesalers will have to prove their herbal medicines are quality products, safe for use and appropriate for the medical benefit claimed.

They will also have to show that their product has been used for at least 30 years.

The popularity of traditional remedies based on ancient Chinese, Indian and Tibetan medicine has been growing rapidly in recent years. Globally, the market in herbal medicines is now worth an estimated £5 billion a year.

However, controversy has arisen over the efficacy and side-effects of some products. In 1999, the Department of Health - acting on a recommendation of the IMB - ruled that St John's Wort should be available only on prescription.

Dr Des Corrigan, director of TCD's school of pharmacy and chairman of the IMB's scientific committee on herbal medicine, said that a lot of the "disasters" could have been avoided if proper quality assurance procedures had been put in place.

He said the proposed procedures aimed to ensure that herbal medicine producers would not face the burden of expensive clinical trials for new products. "We're not asking people to do expensive clinical trials. They can rely on published scientific literature, on information that's already in the public domain."

It was now up to the Department to decide whether to introduce the regulations, he said. This would probably take place next year.

Customers would benefit through the introduction of more detailed labelling on medicines and a mechanism for reporting suspected side-effects.

The EU is currently preparing a directive on traditional herbal medicines, which will ultimately come into Irish law. However, this is unlikely to take place for some years. It is expected the Irish regulations will be introduced in the interim. However, all products will be allowed to remain on the market during the initial assessment period.

The Irish Association of Medical Herbalists welcomed the consultation involved in the drawing up of the regulations but expressed a number of concerns.

Its secretary, Ms Anna Maria Keaveney, said the 30-year rule was unclear and "potentially restrictive". Herbal practitioners should be exempted from any requirement for a licence to formulate remedies for their patients, she added.