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Chinese herbal medicine stages a comeback

In Taiwan, 15% of patients visit traditional Chinese medical clinics

Seminar on the package labels of Chinese Herbal Medicine. The DOH is promoting current Good Manufacturing system(cGMP).
Warehouse of the GMP-qualified Sheng Chang ( 勝昌)Pharmaceutical Company

Seminar on the package labels of Chinese Herbal Medicine. The DOH is promoting current Good Manufacturing system(cGMP).

Warehouse of the GMP-qualified Sheng Chang ( 勝昌)Pharmaceutical Company

In May, the Bureau of Food and Drug Analysis (BFDA) of the Department of Health announced that 34 illegal packages of herbal medicines shipped from China were tested as containing unsuitable ingredients of anti-impotence drugs, tranquilizers, and narcotics.
Those medicines had labels that said they were composed of Cordyceps (冬蟲夏草), Ginseng(人?), Cistanche(肉蓯蓉) and other healthy herbal medicines. They claimed as having been manufactured with modern biotechnology methods. The DOH said that if they took those drugs, those with hypertension or diabetes could worsen their conditions. Furthermore, their side effects could cause vital damage to society.
"We call on the public to be cautious when purchasing herbal medicines without certifications on their labels," said I-Hsin Lin, Chairperson of the Committee on Chinese Medicine and Pharmacy (CCMP).
In addition, the DOH commissioned the CCMP to set up a mechanism to monitor the source of herbal medicines and materials.
According to the CCMP, the concept of source control and administration has not been established. To build that concept, the government needs to wage a far-reaching information campaign.
Tracking the sources
Controlling imported herbal medicines is difficult. The DOH cannot do a comprehensive inspection at Customs because it is present government policy to facilitate customs inspections and a thorough inspection goes against that policy.
Therefore, the DOH commissioned the local bureaus to implement a comprehensive testing of herbal materials at herbalist clinics on an irregular basis, while the DOH inspects the GMP-qualified drug companies every 2 years. That testing has given rise to a thorough certification system that makes it easier for consumers to recognize high-quality herbal medicines.
Other official certifications, such as GMP, cGMP or GCP, identify the source and the batch numbers, helping trace the product origin, enabling the health authorities to take immediate measures once a package of herbal medicine is tested as harmful.
If one piece of Ginseng (人?) is found harmful, it would be enough to just track its batch number and retrieve the others of the same source. But people tend to reject all the Ginseng in the market.
Besides, the tendency of media to report herbal therapy mishaps in an exaggerated way has misled the public and long stigmatized traditional herbal medicines.
Promoting a certification system
In 1963, the U.S. set up the GMP system to require domestic drug companies to control the manufacturing process of their drugs. The GMP system established specific standards for manufacturing procedures, reducing the possibility of human error and preventing the drugs from being polluted. Those standards achieve a higher efficacy in controlling drug quality instead of simple post-manufacture tests.
GMP has now become a common certification standard for food and drugs. In 1982, the Taiwan government mandated herbal medicine companies to abide by GMP standards.
To continue promoting the GMP system for herbal medicines, the Department of Heath has established a GMP promotion group whose task is to assist herbal medicine companies become GMP-qualified manufacturers. They do this by fielding the experiences of GMP experts from industry and academia.
The supply of facilities and equipment is managed by the Industrial Development Bureau, Ministry of Economic Affairs while the Bureau of Food and Drug Analysis takes care of teaching testing techniques.
The DOH plans to do its work of promotion until a comprehensive GMP-qualified system has been fully established in the herbal medicine industry.
By 2006, 105 herbal medicine companies have acquired GMP certification in Taiwan, while 96 failed the examinations and their licenses were revoked by the health authorities.
Quality System Regulations
Q GMP- Good Manufacturing Practice
The GMP regulation is an international scientific quality standard for manufacture, labeling, installation, and servicing of pharmaceutical, medical devices, and food industries.
Q cGMP- Current Good Manufacturing Practice
An improvement of the GMP regulation, cGMP imposes a more strict standard on the manufactures to meet current situations and ensure the products meet a specific quality standard for manufacture, labeling, installation, and servicing.
Q GCP- Good Clinical Practice
The GCP regulation is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
Q ISO 9001:2000-
ISO 9001:2000 specifies requirements for a quality management system for any organization that needs to demonstrate its ability to consistently provide products to enhance customer satisfaction. The system is currently adopted by EU.
To ensure everyone's safety, the CCMP suggests:
1. Consult the certificated herbalist doctors to avoid receiving illegally-imported or uncertified medicines.
2. Do not buy the products advertised as being highly efficient.
3. Make sure your herbal medicines bear GMP certification on their packages.
4. If your herbal materials have no GMP certification, at least make sure they have expire dates, batch numbers and manufacturing sources.
One of the objectives of the DOH is that before the year of 2008, all Chinese herbal medicines should have complete labels.
A clear labeling system enables the consumers to identify the brands and helps us to inspect and track the sources of the herbal products.
Controlling harmful medicines
To promote the safety of citizens, the Department of Health, Taipei City Government last year started providing free testing service of herbal medicines. People are welcome to send their herbal medicines, from legal sources, night markets, quacks, or illegally imported from China, for inspection.
The DOH not only endorsed the Taipei City Government's policy, but also urged it to give harsh penalties on the illegal cases. Meanwhile, the DOH called on the public to report violations. For example, cinnabar(硃砂) is banned in both internal and external use. Consumers are encouraged to inform the local bureaus if they bought any herbal medicines containing cinnabar (or suspect they contain cinnabar).
Also the DOH has asked the local bureaus that when they publish news on the safety of herbal materials or medicines, their sources should be clearly stated to avoid public panic and cause losses for legal medicine companies.
The DOH attaches much importance to the quality of herbal materials. Loquat leaf, cinnamon, the stick and peel of cinnamon, bletilla striata (?及), and acanthopanax gracilistylus (五加皮) in 2004 was required to undergo heavy-metal testing before entering the market. In May of the same year, the DOH published "Pharmacopoeia of Chinese Medicine"(中華中藥典), which lists the specific prescriptions of the most common herbal medicines.
There is also a stringent requirement for finished herbal products to have the total amount of heavy metal lower than 100ppm.
Fifteen percent of patients visit traditional Chinese medical clinics, and the figure might even be higher. The DOH is urgently working to create a safe and sound environment of Chinese herbal medicine to guarantee national safety. Through a definite regulation and certification system, it is possible that traditional herbal medicine will follow the path of western medicine, and increase national welfare in a scientific way.