Improving the quality standards for ethnic medicines is underway.

　　“This year, Premier Li Keqiang’s government work report emphasized the vigorous development of traditional Chinese medicine and ethnic medicine. From last year’s ‘supportive development’ and ‘active development’ to this year’s ‘vigorously developed,’ we, as enterprises specializing in ethnic medicines, have keenly felt the call of the times,” said Lei Jufang, a member of the National Committee of the Chinese People's Political Consultative Conference with many years of experience in the field of ethnic medicine and Chairwoman of Tibet Qizheng Tibetan Medicine Co., Ltd., recently. At this year’s Two Sessions, Lei Jufang solemnly submitted a proposal titled ‘Improving Quality Standards for Ethnic Medicine Production’ to the National Committee of the CPPCC, along with another heartfelt appeal for the further development of ethnic medicine.

　　In 2012, the Ethnic Medicine Division of the China National Institute for Food and Drug Control was quietly established. The very first task after its establishment was to conduct a survey on the current status of quality standards for ethnic medicines across nine provinces and regions nationwide. In 2015, the division released a comprehensive report titled “Survey and Analysis of the Current Status of National Ethnic Medicine Quality Standards.” “This is the first comprehensive assessment of the use of ethnic medicine quality standards in China in nearly two decades,” said Ma Shuangcheng, Director of the Chinese Medicine and Ethnic Medicine Testing Division at the China National Institute for Food and Drug Control. “Through this survey, we’ve identified the key bottlenecks hindering the development of ethnic medicines, and a medium- to long-term development plan for ethnic medicines has now been put on the agenda.”

　　Bo: A Treasure Trove of Resources

　　The population of ethnic minorities in China accounts for 6% of the total population, yet their concentrated settlements occupy 60% of China’s total land area. China boasts more than 8,000 species of ethnic medicinal materials, accounting for over 70% of the country’s total medicinal resource inventory. There are over 600 types of standardized ethnic medicines, belonging to the cultural systems of more than 40 different ethnic groups. This reflects an extraordinarily rich diversity—both biological and cultural. According to available data, there are currently over 120 ethnic medicine manufacturing enterprises in China, among which the Tibetan, Mongolian, Uyghur, and Miao medicine industries have already achieved a certain scale.

　　This survey covers nine provinces and autonomous regions across the country, including the Tibet Autonomous Region, Qinghai Province, Gansu Province, Sichuan Province, and others—areas where China’s ethnic minority groups are predominantly concentrated. The survey encompasses seven types of traditional medicines, including Tibetan medicine, Mongolian medicine, and Uyghur medicine, involving a total of 1,125 varieties of ethnic medicines, 137 ethnic hospitals, and 7,102 hospital-prepared formulations. Overall, the survey provides a comprehensive overview of the current state of ethnic medicines.

　　It is understood that since the founding of New China, our country has introduced a series of policies on ethnic medicine, greatly promoting the development of the ethnic pharmaceutical industry. In particular, since 2010, research on ethnic medicine has received unprecedented attention. The State Ethnic Affairs Commission, the Ministry of Science and Technology, the former Ministry of Health, and other relevant authorities have successively established major research programs aimed at systematically studying aspects such as cultural heritage, specialized research, resource surveys, and the treatment of major diseases, thereby elevating the quality development of ethnic medicines to a level “on par with traditional Chinese medicine.”

　　Ma Shuangcheng introduced that in December 2012, the National Institute for Drug Control specially established a Traditional Ethnic Medicine Laboratory within the Institute of Chinese Medicine and Ethnic Drugs. This laboratory conducts quality testing and research on ethnic medicines at the national level, explores new models suited to the development of ethnic medicine quality control, and enhances the conceptual framework for ethnic medicine quality inspection. In June 2013, the Institute of Chinese Medicine of the National Institute for Drug Control hosted a symposium on ethnic medicine testing and standardization research in Urumqi, Xinjiang. The symposium aimed to discuss the establishment of an ethnic medicine quality assurance system, strengthen the development of reference materials for ethnic medicines, and advance research into new technologies and methods for ethnic medicine quality control. This conference came to be known as the “Xinjiang Conference.”

　　It is reported that China’s ethnic medicines primarily adhere to three categories of production quality standards: the Chinese Pharmacopoeia, ministerially issued standards, and local standards. The concept of “ethnic medicines” first appeared in the 1997 edition of the Chinese Pharmacopoeia, which began including medicinal materials from ethnic minority groups under the category of “traditional Chinese medicinal materials,” and also included proprietary formulations made from these materials. The 2010 edition of the Chinese Pharmacopoeia lists a total of 14 ethnic medicinal materials and 26 ethnic proprietary formulations. In December 2002, the former State Drug Administration, following expert review, converted 435 local standards for ethnic medicines into national standards. To date, there are a total of 1,209 national standards for ethnic medicines, including more than 300 medicinal materials and nearly 900 proprietary formulations.

　　The survey shows that China has 1,126 types of ethnic medicines governed by local standards. Provinces (autonomous regions and municipalities) including Yunnan, Sichuan, Guangxi, Tibet, Qinghai, Xinjiang, and Guizhou have successively published a series of local standards for ethnic medicines. These standards have made significant contributions to ensuring the safety and efficacy of ethnic medicines during specific historical periods. (See Figure 1)

　　Worry: Conflicting standards

　　“The chaotic quality standards for the production of ethnic medicinal materials and finished medicines are the main bottleneck hindering the development of ethnic medicine,” said Lei Jufang.

　　The survey shows that the current problems with ethnic medicine standards mainly fall into the following areas:

　　First, there is confusion regarding the botanical origins of ethnic medicines and a lack of uniform standards. Ethnic medicines are often traditional Chinese herbs or folk remedies and powders passed down through generations in local communities. Because of their unique therapeutic effects, low costs, and easy availability, they have long been trusted and widely used by ethnic minority groups. However, for a long time, due to differing medicinal practices among various ethnic groups, standard regulations for the same medicinal materials have varied significantly across different regions inhabited by ethnic minorities, leading to considerable confusion about the botanical origins of these medicines and a serious issue of “same name, different substances.” Take Tibetan Berberis bark as an example: In the 1979 edition of the “Tibetan Medicine Standards,” it was defined as the inner bark of stems or roots of species such as Berberis stricta and Berberis spp.; yet in the 1992 edition of the “Qinghai Tibetan Medicine Standards,” it was instead specified as the dried bark of Berberis gansuensis, a species belonging to the Berberidaceae family...

　　Second, among the varieties of proprietary Chinese medicines and hospital preparations, some medicinal materials lack established standards, leading to a reverse situation. This is particularly true for multi-source and poorly defined medicinal materials—standards fail to specify the botanical origins of these materials, thereby posing potential risks to the efficacy and safety of finished products. For example, Baxia’ga is a commonly used medicinal material in Tibetan medicine. The 2010 edition of the Chinese Pharmacopoeia includes a formulation called “Shisanwei Bangga San,” which is a time-tested Tibetan prescription containing Baxia’ga as one of its ingredients. In the first volume of the former Ministry of Health’s Standards for Tibetan Medicines, dozens of proprietary formulations—including “Ershiwuwei Datang Wan” and “Ershiwuwei Guijiu Wan”—also contain this medicinal material. However, due to the historical challenges of transportation and inheritance factors, the botanical origins of Baxia’ga used in different regions of Tibet have long been highly inconsistent and thoroughly confused.

　　Third, there’s the issue of translation. Some medicinal materials, when translated into Chinese, end up having the same names as traditional Chinese medicine ingredients, yet they actually originate from different plant species. This situation is particularly prone to misuse. For example, in Uyghur medicine formulations, the ingredient referred to in Chinese as “Xixin” is, in fact, prepared using the Uyghur term “Asarong” (transliterated). Currently, there is no established standard for this ingredient, and further identification of its botanical source is needed. However, the ingredient’s name should be changed to “Asarong,” rather than the Chinese medicine term “Xixin.” Another example is agarwood in Tibetan medicine, which is used in many proprietary formulations, such as the Eight-Flavor Agarwood Pill listed in the Ministry’s standards. The agarwood specified in these prescriptions does not refer to the agarwood sourced from Aquilaria malaccensis found in traditional Chinese medicine; instead, it refers to what is known as “Tibetan agarwood.” In Tibetan medicinal materials, “Tibetan agarwood” also originates from a variety of plant species, leading to considerable confusion regarding its botanical identity. Yet, due to translation issues between Tibetan and Chinese, referring to it simply as “agarwood” is clearly inappropriate.

　　Fourth, the processing of ethnic medicinal materials possesses distinctive characteristics; therefore, research on standardized processing methods for medicinal materials from various ethnic groups should be conducted. For example, mineral-based medicinal materials hold an important position in Tibetan medicine, yet their botanical origins and processing methods vary considerably, and there is a lack of uniform testing standards. Consequently, research on standardized processing procedures for Tibetan mineral medicinal materials should be undertaken.

　　Fifth, regarding the quality and safety of Tibetan medicine, current efforts are limited to detection methods—for example, the testing for certain heavy metals and toxic or harmful elements—but it remains challenging to establish standardized criteria.

　　Sixth, the origins of imported medicinal materials are unclear, and there is considerable confusion in their use by markets and hospitals. This necessitates a significant amount of time spent tracing and clarifying their true origins. Of the more than 300 varieties of Tibetan medicinal herbs, 20 to 30 percent are imported. For example, Eurasian Polypodium, Dragon's Blood, and European Gentian are all imported medicinal materials. Currently, the variety available in hospitals and markets is highly confused, with many being counterfeit products. Imported medicinal materials are unstable and their origins remain unclear.

　　“The work of translating and compiling ancient Tibetan medical prescriptions is extremely important. However, there’s currently a severe shortage of personnel who are both proficient in Tibetan medicine and fluent in Chinese. As a result, many Tibetan medicines with proven efficacy and remarkable therapeutic effects remain unutilized simply because they lack the necessary documentation and approval procedures—and some are even gradually being lost to history. Many veteran Tibetan physicians are now elderly, making it imperative that we urgently undertake efforts to rescue and document their knowledge,” said Sangde Caiyang, inheritor of intangible cultural heritage in Tibetan medicine and deputy director of the Tibetan Hospital in Golog Prefecture, Qinghai Province. “Many of our hospital’s formulations originate from ‘Kangcang Zhujia Medical Case Collection,’ a book that gathers treatment methods for over 40 infectious diseases. It’s an incredibly valuable resource—but unfortunately, it’s currently written entirely in Tibetan. Moreover, many of the medicinal herbs it describes remain largely untapped and unexplored.”

　　In addition, Wang Ren, a pharmaceutical expert from the Kazakh Hospital in the Altay Region, introduced that the Altay Region is home to many species unique to the area, such as Altay Daphne. The Kazakh people often use it to treat colds, and it can be cultivated; however, it has not yet been standardized. There are numerous similar examples in ethnic minority regions across the country.

　　Joy: The plan is on track.

　　In fact, another factor influencing the promotion of ethnic medicines is the already-implemented standards for finished ethnic medicine products. Director Ulan of the Inner Mongolia International Mongolian Medicine Hospital explained: “Because of their distinct ethnic characteristics, finished ethnic medicines differ from traditional Chinese medicines, leading to numerous application challenges. In Mongolian medicine, we don’t use the traditional Chinese medicine decoction pieces; instead, we grind them into powders and then prepare the prescriptions accordingly. Nowadays, once a Chinese medicine product is ground into powder, it can only be referred to as a dosage form—not as a decoction piece anymore. This limitation restricts Mongolian medicine’s ability to tailor prescriptions to individual patients.”

　　“The dosage standards for ethnic medicines need further standardization. As long as the dosage is properly calibrated, the safety of ethnic medicines can be effectively ensured,” said Zhao Qizhong from the Drug Inspection Institute in Pu'er City, Yunnan Province. He cited as an example the Fumeidengmu tablets—a traditional medicinal herb used by the Dai ethnic group, which was developed in the 1970s. During the acute toxicity testing conducted as part of the registration process, some rats died. However, this herb has been used for over 500 years, demonstrating that as long as the dosage range is carefully controlled, there’s no problem with its safe use.

　　Notably, the “National Pharmaceutical Inspection System Development Plan for Ethnic Medicines (2014-2020)” has been completed following a comprehensive survey. Ma Shuangcheng introduced that the plan’s specific objectives for the 13th Five-Year Period include developing and distributing 200 reference substances for ethnic medicines—covering reference medicinal materials, reference standards, and reference extracts—as well as establishing a technical platform for the inspection of ethnic medicines to significantly enhance inspection capabilities. Additionally, the plan aims to complete the standardization of 50 key ethnic medicinal materials, elevate both national and local standards, and solidify and improve the foundational work related to ethnic medicines. Furthermore, it seeks to accelerate the development of a qualified workforce for ethnic medicine inspection by increasing the number of specialized technical personnel. Led by the national government, with 10 to 20 years of concerted effort, the plan envisions substantial progress in quality control for ethnic medicines, bringing their standards up to or near the level achieved by traditional Chinese medicines and ensuring an adequate supply of reference substances for ethnic medicines.

　　Reporting media: China Pharmaceutical News

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