Ayurvedic medicines face EU ban from May 1

Users and promoters of such medicines have called the EU directive called The Traditional Herbal Medicinal Products Directive, 2004/24/EC, "discriminatory and disproportionate".
Ayurvedic and traditional herbal medicines will need to licensed to comply with the EU directive passed in 2004, which takes effect from May 1.

Official sources said those ayurvedic products marketed before the legislation came into force in 2004 can continue to market their product until April 30, 2011, under the transitional measures.

Once this time limit has expired, all herbal medicinal products must have prior authorisation before they can be marketed in the EU. Ayurvedic medicines such as "ashwagandha" will not be available for sale across Europe from May 1.The directive aims to protect users from any damaging side-effects that can arise from taking unsuitable medicines.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued more than a dozen safety alerts in the past two years, including one over aristolochia, a banned toxic plant derivative, which reportedly caused kidney failure in two women.
After the ban comes into effect, only high quality, long-established and scientifically safe herbal medicines will be sold over the counter, official sources here said.

Herbal practitioners say it is impossible for most herbal medicines to meet the licensing requirements for safety and quality, which are intended to be similar to those for pharmaceutical drugs, because of the cost of testing.

According to the Alliance for Natural Health (ANH), which represents herbal practitioners, not a single product used in traditional Chinese medicine or ayurvedic medicine has been licensed.

Producers and independent health store owners allege that the directive draconian and favours large European manufacturers, but smaller firms will be in danger of being squeezed out of the market.

Under EU law, statutorily regulated herbal practitioners will be permitted to continue prescribing unlicensed products, but the government in Britain has delayed plans to introduce a statutory herbal practitioner register

A spokesman for the Department of Health said no decision had been made on a statutory register of herbal practitioners.

"The Government is aware of the strength of feeling on this issue and is actively exploring options."

Dr Rob Verkerk, of the ANH, told The Independent: "Thousands of people across Europe rely on herbal medicines to improve their quality of life. They don't take them because they are sick – they take them to keep healthy.

If these medicines are taken off the market, people will try and find them elsewhere, such as from the internet, where there is a genuine risk they will get low quality products, that either don't work or are adulterated."

However, Richard Woodfield, of the Medicines and Healthcare Products Regulatory Agency, said: "What regulation does is to ensure products meet assured standards. Although the standards are challenging, they are achievable and manageable".