China's SFDA revokes 15 GMP certificates

China's State Food and Drug Administration has revoked Good Manufacturing Practice certificates from 15 drugmakers, ordering a further 13 to rectify production defects, following the unannounced inspection of 35 facilities in September, according to the state-owned Xinhua news agency. Seven other drug firms have had their applications for GMP status put on hold, pending further investigation.

Zhang Jixiang, a spokesman for the SFDA, told reporters that problems with the Xinfu antibiotic injection (clindamycin phosphate glucose), made by Anhui Huayuan Worldbest Biology Pharmacy Co, led to seven recorded deaths across China in July (Marketletter August 14).

Mr Zhang said: "companies should think very seriously about this catastrophe, run their businesses honestly and stick to the law." The SFDA has revoked Anhui's manufacturing license and dismissed the firm's senior management. The local provincial Food and Drug Bureau will destroy all recalled drugs, seize illegal company funds and impose a fine, in accordance with China's Drug Management Law, Mr Zhang added.