China in latest drug safety offensive

By Emilie Reymond

- Last updated on GMT

Related tags: Pharmacology, China

Chinese drug manufacturers could be given a 24-hour deadline by
regulators to pull unsafe pharmaceuticals off the market or face a
fine, a Chinese newspaper reported.

According to an article in the China Daily, the country's State Food and Drug Administration (SFDA) has realised a draft plan on drug recalls and is seeking public feedback. The agency divided drugs that must be recalled into three categories, with the first being potentially fatal and harmful drugs, which must be withdrawn within 24 hours, the report said. The second category concerns drugs that may cause temporary health problems and pharmaceutical firms would have three days to recall these. Finally, the third category includes drugs that must be recalled within seven days for other less severe effects such as inappropriate packaging, according to the China Daily article. If a potential safety issue is established, the draft proposal requires the drug company to recall the product, and inform distributors, users and the public of the possible side effects. On the flip side, retailers and hospitals who find a potentially dangerous drug must immediately stop selling and using it, inform the manufacturers, and submit a report to the authorities. Failure to do so can lead to fines ranging from 1,000 to 50,000 Yuan (€95 to €4,770), and in some serious cases revocation of licenses. This is a latest of a series of actions the country has taken of late in a bid to tackle its international reputation as a producer of unsafe drugs. Most recently, China announced an initial $1.7bn investment to bolster its currently questionable ability to effectively monitor the quality of the food and drugs manufactured within its borders. And in June, China's top administrative body, the State Council, announced a series of regulatory reforms, vowing to place new controls on drug (and food) imports and exports by 2010 and to increase the proportion of such products that are subject to random inspections to 80 per cent - currently the figure is only 30 per cent. China has suffered from a dubious reputation in the pharmaceutical industry for several years. In one high profile case in May 2006, nine people died in the country after being injected with a concoction of Armillarisni A that contained a fake and toxic ingredient. In Panama last year, more than 40 people died after taking cough syrup, antihistamine tablets, and calamine lotion which contained glycerine that was contaminated with diethylene glycol (DEG), a poison used in antifreeze and as a solvent. The glycerin was originally sourced from China.

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