China Drug Bureau to Standardize Traditional Medicine Names
The names of traditional medicines should be straightforward, honest, and inspired by China’s rich cultural heritage, the country’s drug regulator announced Tuesday.
Weighing in on the nomenclature of traditional Chinese medicine (TCM) products for the first time, the China Food and Drug Administration (CFDA) issued a guideline stating that the name of a medical product cannot embellish or exaggerate its effectiveness, and should reflect the “cultural essence” that was such a defining characteristic of prescriptions in ancient times.
The guideline gives the example of yuehua wan, or the “moonlight pill,” often used to treat lung disease. According to TCM theory, the lungs are commonly associated with yin — part of a Taoist philosophical concept that splits the world into opposing but complimentary forces, such as sun and moon — because they sit high in the chest, like a celestial body in the sky.
“While the names of new products are regulated, they lack the traditional characteristics of TCM’s rich history,” the CFDA said in the guideline. Only 3.2 percent of products registered since 2007 have names referencing cultural heritage, it added; as such, manufacturers should make a greater effort to use rhetorical devices like metaphors and puns to add a little cultural flair to their products.
A previous guideline of approved drug names was issued in 2006 by the Chinese Pharmacopoeia Commission, the body responsible for compiling and updating the country’s official compendium of Chinese and Western medicine, but its provisions for TCM product names were not particularly strict. By contrast, the World Health Organization mandates that the names of registered Western medicines not make any reference to their efficacy — a requirement that has never been imposed on Chinese treatments.
But in its recently issued guideline, the CFDA explicitly states that TCM must adhere to this standard. Ling, which means “effective” in Chinese and is frequently found on product labels, is now banned — as are names of people and places, except in cases where the products have become “classic prescriptions” under such a name over a long period of time.
“The name of a medicine, too, should be subject to standards,” Bi Jingquan, the head of the CFDA, said in an interview with state media in February, when the administration made a draft version of the guideline available to the public. Bi explained that under the current situation, customers find some product names to be misleading.
In a notice posted after the guideline’s release, the CFDA said that a committee of experts from the Chinese Pharmacopeia Commission would conduct a thorough review of all TCM products on the market, order any disingenuous products to change their names, and give manufacturers two months to propose alternative names.
No products would be recalled, the CFDA clarified: The same products with new names would be phased in gradually over a two-year transition period, first with labels bearing both the old and new names, and eventually with just the new name, so as not to confuse customers.
With TCM gradually coming back into fashion thanks to a cultural shift toward “natural” consumption, the government is pushing for more development and regulation of this prized cultural heritage. In June, the CFDA shut down 81 TCM companies for violating manufacturing and quality control standards. Later the same month, a self-professed health guru was found to be peddling medicines on TV under nine assumed identities, including those of actual TCM experts.
Editor: David Paulk.
(Header image: A worker handles drug capsules at a pharmaceutical factory in Bozhou, Anhui province, April 8, 2013. Zhang Yanlin/IC)