Article 6

Modernization of Chinese Herbal Medicine Moves Ahead

By Kevin A. Miles

from the California Journal of Oriental Medicine

As traditional Chinese medicine becomes more popular and mainstream in the U.S., there is ironically also a growing perception that Chinese herbs are unclean and unsafe. In order to abate the concerns of consumer and regulatory agencies, the Chinese herb industry is responding with a comprehensive project of modernizing the production, cultivation and manufacture of herbs used in traditional Chinese medicine.

But what does that mean, exactly?

Michael McGuffin, President of the American Herbal Products Association, emphasizes that modernization does not mean pharmaceuticalization. "Modernization is not about figuring out what the active ingredient in yin qiao is, and then extracting that compound and dropping the other 17 herbal components out of the equation," McGuffin said. "Modernization concerns itself with ensuring the herbs are clean, unadulterated and properly identified. "McGuffin cites knowing what the, heavy metal load is as an example.

To most, modernization means beginning with adopting Good Manufacturing Practices (GMPs). According to Roy Upton, President of American Herbal Pharmacopeia, CMP involves establishing the identity of herbs, guaranteeing a level of freedom from harmful microorganisms, and controlling heavy metal contaminants, through clear guidelines of manufacturing. "GMPs are absolutely necessary to attain a level of quality," Upton said. "They're modern methods of identification to prevent adulteration." Once GMPs are widely established in China, consumers and regulators would have little cause to express doubt about the quality of the herbal products used in Chinese medicine.

Upton says that China is now taking positive steps toward adopting better manufacturing practices. "They're even beginning the process of bringing people trained in Good Agricultural Practices (GAPS) to the growing areas." GAPS focus on the cultivation, where GMP focuses on production of finished products. GAPS include ensuring that clean and widely accepted farming and harvesting methods are used to meet quality and safety standards.

According to Upton, adoption of GAPS is causing some displacement of Chinese farmers, as some land is being deemed unfarmable due to environmental degradation Yet instead of sounding the familiar battle cry of imperialism and intervention in domestic affairs, Beijing is taking great strides to respond pro-actively to Western concerns about the safety and quality of herb products produced in China. The party line, as expressed through the Hong Kong Secretary of Commerce and Industry Chau Tak Hay, stresses that "the success of Chinese medicine as a source of alternative and complementary medicine in the international market will depend on our ability to understand market information, meeting regulatory requirements, scientific development, quality assurance, and product standardization." This is interesting because the stated goal of the government is not to obtain a Chinese objective or goal, but rather to satisfy Western regulators and consumers.

Problems with Chinese herbs, however, are not always due to a lack of regulation or control in China. Herbs have been regulated in China for several hundred years. Much of the problem is a lack of understanding of China's system of regulation, and differences in the Chinese way of doing things and standard international practices. Chinese herb regulation is often poorly understood in this country. It seems that government regulators erroneously assume the industry is as new and uncontrolled as it is in this country, but even worse because it's happening in a developing country. As a result, many consumers in the US are not willing to put their faith in Chinese herbal medicine.

Indeed, China has thoroughly regulated herbs used in Chinese medicine. There's a tremendous wealth of herb knowledge and regulation in China, but because of the language barrier, the US Food and Drug Administration (FDA) often acts as if herbs are a complete unknown. There's a very precise understanding of how different herbs interact with each other, and how and when they should be used, but much of that data is still unavailable in English or inadmissible to the FDA. Herbs have to start from square-one, and so there's an illusion of uncertainty - and that does not help with the public's perception of herbs.

Nevertheless, in China today, there is a rush (a ten-year plan started in 1999 to be exact) to modernize TCM regulations to meet the concerns of Western consumers and regulators. Funding in excess of $100 million dollars has been poured into educational and research institutions, as well as regulatory bodies. For example, the PRC Ministry of Science and Technology recently announced plans to set up a Reference Standard Center for Chinese medicine. This project, based out of Hong Kong, will bring a new level of standardization for TCM herbs by establishing an authoritative and meticulous classification of each and every herb.

According to Albert Wong, president of the Hong Kong based Modernize Chinese Medicine International Association (MCMIA), China is keen on meeting Western standards. "In China, modernization of Chinese medicine is now a national policy priority and the acronyms such as GMP, GCP, GLP and even GAP are not just foreign letters but actual practices to be implemented soon," Wong said.

McGuffin believes that the PRC government is committed to the modernization effort. "They understand they have a treasure in their medicine and that the world is willing to purchase that treasure," McGuffin said. "They're very receptive to understanding what sort of rules need to be adopted to pursue trade to with the US and Europe."

So now comes the hard part.

Indeed, there is a concerted effort on the part of the PRC and Hong Kong governments to make Hong Kong a centralized hub of TCM education, quality control and production. "Hong Kong has a Western industrial and educational infrastructure which does not exist in the mainland," Upton said. "If all of the herbs funnel through one place, it would stream-line the quality assurance and shipping procedures."

To facilitate the creation of this hub, the HKSAR Government has also set up an Institute of Chinese Medicine to strengthen the scientific and technological base of TCM. In 1999, the Hong Kong Jockey Club earmarked $64 million US to support the institute's research programs and activities.

Perception also plays a role. Hong Kong clearly has a better image in the West than the mainland. As Hong Kong ascends as the hub of TCM, there will certainly be a de-mystification of herbal medicine.

In the Spring of 2002. Hong Kong hosted the first-ever international conference on the modernization of Chinese medicine. A four-day trade show with about 600 industry attendees, the conference focused on addressing concerns about the modernization of Chinese medicine with regard to the cultivation of herbs and clinical research. It was organized by the Hong Kong Jockey Club Institute of Chinese Medicine (HKJ-CICM) and the MCMIA. McGuffin presented at the conference. "There was a good mix of Mainland, Hong Kong and North American presenters," McGuffin said. "It showed things are clearly moving in the right direction."

ABOUT THE AUTHOR:

Kevin Miles has a degree in Chinese from the University of California, Santa Cruz. He has lived and studied in Taiwan, and plans to return to China to continue his study of Chinese language and culture. He lives in Oakland, California.