Draft rule: 24-hour recalls for harmful drugs
21 September 2007
A draft regulation by the State Food and Drug Administration (SFDA) will require drug makers to recover dangerous or deadly medication from consumers within 24 hours of a recall, state media reported. The 24-hour rule will take effect under a three-tier recall system based on international practices indicating the level of health concern of the drug recalled. The draft regulation stipulates SFDA will hold drug makers accountable for health scares triggered by problematic drugs, and drug makers will face fines of up to three times the value of the drugs involved with a possible revocation of their licenses, in addition to bearing the costs of the recalls. Hospitals and retailers of problematic drugs will also be fined US$132 to US$62,393, or have their licenses revoked in serious cases if the drugs continue to be sold after the recall. The final version of the draft regulation will be implemented October 8, after feedback from stakeholders and drug companies, a spokesperson for SFDA said.
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