International Standard of Isatis Indigotica Root

In last year, International Standardization Organization (ISO) released Traditional Chinese Medicine - Isatis Indigotica Root, an international standard about isatis indigotica root which is a traditional Chinese medicine and called Banlangen in Chinese.

In experts’ view, this standard will play a critical role in promoting international standardization of isatis indigotica root, improving its international influence and even pushing forward its international trade.

Isatis indigotica root is a kind of traditional Chinese medicine, functioning to clear away heat and toxic material.

Indications of isatis indigotica root are: plague, fever, soar throat, mumps, scarlet fever and erysipelas... It has become a common medicine in medical markets. And isatis indigotica root is a raw material for many products.

Early to 2014, the proposal of Traditional Chinese Medicine - Isatis Indigotica Root was submitted to ISO/TC249 in order to further regulate market and standard of isatis indigotica root, promote quick development of its production chain and improve international influence and competitiveness of isatis indigotica root.

May of 2016 saw the approval and project of this proposal after voting. It is learned that the final standard was developed by experts and project teams from six countries including China, Germany, Canada, Australia, Korea and Thailand for 34 months.

The team drafted this standard on the basis of isatis indigotica root standard in Chinese Pharmacopoeia and international standard preparation rules. Besides, they prepared this standard from aspects of origin, range, definition, technical requirements and detecting rules... The standard also defines some control indicators of pesticide and heavy metals according to international requirements.

However, the standard publishing doesn’t symbolize the appearance of definite scientific basis and international standard for clinical efficacy and safety of isatis indigotica root preparations.

In fact, even in Germany and Japan where Traditional Chinese medicines are widely produced and used, preparations related to isatis indigotica root are still not auxiliary medical products, health-care product or food, instead of the mainstream medicine in clinical treatment.

As experts say, it’s far away from isatis indigotica root preparations’ being accepted by professional clinical staff, even though the medicine has obtained ISO international standard. There should be further scientific studies on their clinical efficacy and safety.

It is certain that Chinese medicine international standardization is a necessary means to promote globalization of Chinese medicine. Till now, many national standards have been published. They are all about traditional Chinese medicine, such as panax notoginseng, artemisia argyi, ganoderma, isatis indigotica root, dendrobium officinale...

Besides, other international standards are all in preparation, including standards about gastrodia elata, golden-and-silver honeysuckle, female ginseng, lycium chinense, milkvetch and platycodon grandiflorus. According to statistics, ISO/TC249 has released 35 international standards about traditional Chinese medicines and are preparing other 41 standards.

To sum up, the international standard about isatis indigotica root cannot only promote scientific development of isatis indigotica root industry, but also provide power for the future traditional Chinese medicine technical standard and regulation, traditional Chinese medicine’s influence and internationalization. In addition, China can also pay attention to culture of international and standardized talent on traditional Chinese medicine. Only by these ways, can China have the ability to lead international standard drafting.