HerbalEGram: Volume 10, Issue 7, July 2013

For the first time, a Tibetan herbal medicine product has received Traditional Herbal Registration (THR) from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).¹ The registration was issued under the European Union’s Traditional Herbal Medicinal Products Directive (THMPD).² Adopted in 2004 and fully implemented in May 2011, the THMPD lays out a process for obtaining THR, which enables the herbal product to feature limited health claims based on safety assessments and documented traditional use (Herbal supplements without a THR cannot make health claims). While the Directive has EU-wide reach, each member state is charged with enforcing its own registration program.

In late February 2013, MHRA announced its granting of THR to Padma Europe GmbH (Vienna, Austria) for its traditional Tibetan Circosan^® capsules, which contain almost two dozen different herbs.³ The MHRA’s website states that the Circosan capsules are “a traditional herbal medicinal product used to relieve the symptoms of Raynaud’s syndrome and for the relief of symptoms associated with minor venous circulatory disturbances such as tired heavy legs, pain, swelling, and for calf cramps, based on traditional use only.” Raynaud’s syndrome, also known as Raynaud’s phenomenon or Raynaud’s disease, is characterized by numbness and coolness of bodily extremities (toes, fingers, tip of nose, etc.) when exposed to cold temperatures or when the affected person is under considerable stress.¹ It is often symptomatic of inadequate circulation.

A Padma press release on the THR explains that Circosan is a “complex blend of 20 herbal ingredients including the myrobalan fruit [Terminalia chebula], one of the highly esteemed medicinal herbs of [Traditional Tibetan Medicine]. According to the tradition of Tibetan medicine, Padma Circosan^® is used for its stimulating effects on the circulatory system. Given the special challenges this unique formulation presented, the registration of this product is a great success for Padma Europe Ltd.”¹

Tibetan herbal medicine is an ancient and distinct blend of the pre-existing and largely spiritual Tibetan medicine system with Traditional Chinese Medicine, Ayurveda, and Middle Eastern traditional medicine. While there are over 300 herbal products with THR status in the United Kingdom, and hundreds more in other EU countries, this marks the first traditional Tibetan product to be registered (Padma Circosan also has a THR in Austria).¹ The THMPD’s purpose is to provide a simplified marketing process for herbal products that are not able to meet stringent efficacy proof that is required of products approved as medicines but have therapeutic relevance based solely on a history of their traditional use.²

“Registrations of products from outside the Western phyto-medicinal paradigm are significant because they illustrate that the Directive actually works and/or provides an advantage in situation where clinical evidence of efficacy is not available,” said Thomas Brendler, a natural products industry consultant and founder and CEO of PlantaPhile (email, June 11, 2013).

Still, some groups have criticized the Directive’s requirement for evidence of at least 15 years usage of the preparation within the European Union, in addition to the 30 years of traditional use in the product’s country of origin.² This is a particularly difficult condition to meet for non-European products, such as those from the traditional Chinese and Ayurvedic systems of medicine, and, indeed, few herbal medicines from non-European traditions have obtained THR (Brendler estimates no more than a handful, but with many more in the pipeline).

While the UK’s THR for the traditional Tibetan Circosan product is undoubtedly significant, because the company has long-established Swiss roots, it thus had somewhat different prospects than companies outside of Europe. According the company press release, Padma’s Circosan was able to meet the 15 years stipulation because “the traditional formula reached Europe in the late 19^th century, with use by doctors of both Western and Tibetan medicine ever since. In Switzerland, the corresponding product has been used for more than 40 years.”³

Adding to the significance of Padma’s recent THR, the Circosan tablets contain 20 herbal ingredients. Brendler noted that obtaining a THR for a combination herbal product is more challenging.

“In the quality documentation, markers for each individual ingredient need to be described, as well as test methods and their verification,” he said. “The more ingredients, the more complex the documentation becomes. The same goes for stability: you have to be able to show that each individual ingredient is stable on its own as well as in the finished product.”

—Lindsay Stafford Mader


References

1. The first Traditional Herbal medicine Registration (THR) for a product based on Traditional Tibetan Medicine has been granted in the UK [press release]. Vienna, Austria: Padma Europe GmbH; April 2013. 

2. Stafford L. THMPD effects on Ayurveda and Traditional Chinese Medicine. HerbalGram. 94;24-26. Available here. Accessed June 18, 2013.

3. List of products granted a Traditional Herbal Registration (THR). Medicines and Healthcare Products Regulatory Agency website. Available here. Accessed June 10, 2013.