While some Western countries have not warmly welcomed some products labeled as traditional Chinese medicine, in part some of the products contain large amounts of heavy metals, the Shanghai Food and Drug Administration announced yesterday it will update its regulations on TCM processing in October to address the problem.
By June next year, the city will issue processing guidelines on 700 to 800 common TCM materials to ensure production will meet international standards on toxic chemicals.
"We are aware that some TCMs have certain side effects and have issued new rules to control heavy metal and pesticide residues. A new guidance on such issues has been published last year, after considering international practice and our own situation," said Ji Shen, director of TCM department of Shanghai Drug Inspection Agency. "But it is a gradual process. We should control potential harm while inheriting advantages of TCM and ensuring treating effects.'
TCM has long been controversial in Western countries and the recent clampdown by the UK's regulatory efforts have symbolized an East-West clash over TCM, as well as a quality control issue that China is increasingly responding to.
One issue underlying the controversy is the form of mercury that is contained in common TCM preparations.
The UK newspaper, the Independent, last week outlined an ongoing clampdown of unlicensed TCM products. One of the examples listed in the article was the subject of a UK nationwide alert issued by the Medicines and Healthcare Products Regulatory Agency in May on illegal sale and supply of Fufang Luhui Jiaonang.
The product contains aloe and cinnabar, a mercury compound. It's used for treating constipation. The UK agency fined two businesses for selling the preparation, saying they contained substantially more mercury than was acceptable for human consumption by UK standards.
In China, some common TCM products do include mercury, but it's in a compound form, and TCM proponents believe that form of mercury is relatively safe when used as directed by doctors. They complain that Western authorities are applying their standards for mercury based on the presence of free mercury, which is not in a compound form.
"The UK authorities test this medicine under a standard to regulate healthcare food and attribute all mercury in the medicine as free element," said Ji of the Shanghai Drug Inspection Agency.
"It is inappropriate. In China, it is also banned to put cinnabar in healthcare food. Moreover, our experts have started involving more efforts to study cinnabar as medicine."
Du Wenmin, vice director of Shanghai Adverse Drug Reaction Monitoring Center, said cinnabar is a popular ingredient in TCM and the center hasn't received reports on serious side effects after taking such medicine.
(Shanghai Daily August 22, 2006)
