The UK medicines regulator has granted its first licence to a homeopathic remedy under controversial new rules allowing complementary therapies to make medicinal claims.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted an arnica homeopathic product a licence for the relief of sprains or bruising.

Experts say that it contains zero active ingredients and condemned the decision as a “cynical mockery of evidence-based medicine”.

Nelsons Arnicare Arnica 30c pillules are the first product to be given a therapeutic indication via the Homeopathic National Rules Scheme, introduced in September 2006.

As opposed to conventional or herbal medicine, homeopathy is based on the principle that a substance that can make people ill can be diluted thousands of times to treat the symptoms it would otherwise create.

Manufacturers of homeopathic remedies were previously banned from listing the clinical conditions or “indications” that products might be used to treat, due to a lack of evidence that they work.

But under the new license granted by the MHRA, the label on a £5.30 packet of 84 pillules will now read: “A homeopathic medicinal product used within the homeopathic tradition for symptomatic relief of sprains, muscular aches and bruising or swelling after contusions.”

The homeopathic pillules are designed to be sucked or chewed and to be taken between meals.

Robert Wilson, chairman of Nelsons, said that the fact that therapeutic indications could be included on the packaging “not only opens the practice of homeopathy up to new users but also gives it added credibility as a safe and natural complement to conventional medicine”.

But Edzard Ernst, professor of complementary medicine at the Peninsula Medical School in Exeter, said there is no evidence that the product has any benefit over a placebo treatment.

“This is a huge rip-off and the label now makes false and misleading claims,” he said. “There is no biological plausibility for this to work — it makes a cynical mockery of evidence-based medicine.”

Nelsons, the largest manufacturer of natural healthcare products in Britain, also produces herbal tinctures for the Prince of Wales’s Duchy Originals brand, which Professor Ernst has also criticised as “outright quackery”.

Last week, the Advertising Standards Authority reprimanded the Duchy brand over its promotional materials, ruling that claims made about the effectiveness of the tinctures were misleading.

Professor Ernst said that arnica-based homeopathic remedies were the most studied of all homeopathic products, but added: “Arnica is actually poisonous if you swallow it, so these pills contain essentially zero active ingredient.”

A randomised trial published by Professor Ernst and colleagues in 2003 showed no benefit from arnica in prevention of pain and bruising after surgery for carpal tunnel syndrome, with more adverse events in the arnica group than with placebo.

He added that systematic reviews of all studies, including those from advocates of homeopathy, came to the same conclusion.

Bruises and sprains would heal in time, so people would not be doing themselves harm if they took the pills, he said, “but you might as well be swallowing water”.

The MHRA said that the National Rules scheme was introduced to resolve an inconsistency in European legislation that meant that homeopathic products introduced before 1992 could state indications for their use, whereas remedies approved after that date could not make such claims.

A spokeswoman for the Agency said that the National Rules Scheme “involves the assessment of quality, safety and consumer information”.

“This means that if an applicant can demonstrate that their product has been used in the UK homeopathic tradition for the relief or treatment of specific minor conditions or symptoms then the applicant may be granted a homeopathic marketing authorisation.”

But, she added: “Indications are limited to the relief or treatment of minor symptoms or minor conditions, ie, symptoms or conditions which can ordinarily and with reasonable safety be relieved or treated without the supervision or intervention of a doctor.

“Indications for serious conditions are prohibited.”

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