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China Firm Embroiled in Ketamine Scandal
World Pharmaceutical News No. 2986
Sep 10 2004 ©PJB Publications Ltd 2004
More than nine million vials of injectable ketamine have disappeared from China's pharmaceutical distribution network. The rapid-acting anaesthetic can be easily converted form liquid to powder form and sold on the black market, as a potent narcotic.

Following an audit in June, the food and drug bureau in China's central Hunan province discovered that 3,092 cases (9.3 million vials) of the product had vanished from the official paper trail over the preceding year. According to a report in Beijing's China Youth Daily, which exposed the affair, this amount could be converted to 900 kg of powder worth about Yuan 100 million (US$12 million) on China's illegal drug market. Reports say the missing ketamine had been supplied to 13 specially licensed distribution firms in the province by Fangming Pharmaceutical in Shandong province.

In September 2003, the Chinese State FDA named 16 domestic manufacturers, including Fangming, as exclusive authorsed producers of ketamine in China. It reclassified the product as a class II psychiatric drug at the time, limiting trade to licensed wholesalers and prohibiting sale in retail pharmacies. More than half of the missing ketamine was sold after the re-classification (ketamine was further recategorised as a class I psychiatric drug this July).

The 13 accused drug wholesalers in Hunan claim to have been duped by unknown buyers who used fake pharmaceutical trade licenses and identification to procure the injectables. Buyers posed as representatives of hospitals and of non-existent drug trading firms, said the China Youth Daily, noting that sellers did no confirm the validity of the buyers' documentation. The newspaper also points out that the missing amount far exceeds Hunan's medical demand for ketamine, which amounts to just over 100 cases a year.

...criminal code changes?
Authorities have revoked the class II pharmaceutical trading licenses of nine of the 13 accused firms in Hunan and fined them Yuan 30,000 each. They are likely to avoid criminal prosecution, however, as China's criminal code has no provisiobns for illegal sale of ketamine. That could change after a July 2004 ruling in Sichuan that placed ketamine in the category of "other narcotics", making unauthorised trade a criminal offence in that province. Other provinces are expected to follow suit soon.

The recent recategorisation of ketamine into class I should serve to restrict distribution, while China's latest nationwide crackdown on illegal drug use is also targeting ketamine as an emerging threat, reports the China Daily.