The national drug watchdog in China has revoked Anhui Huayuan Worldbest Biology Pharmacy Co's production license for injections it produces and sacked the company's top management.
The manufacture of the "Xinfu" drug, which allegedly caused six deaths in China in July, had been banned, spokesman Zhang Jixiang of the State Food and Drug Administration said yesterday in Beijing.
He explained that the "Xinfu" antibiotic injection was of inferior quality. The company's Good Manufacturing Practice (GMP) Certificate and its production license for the drug had been revoked.
The Anhui provincial food and drug bureau will supervise the destruction of all the recalled drugs. The bureau will seize illegal company funds and impose a fine in line with the Drug Administration Law, Zhang said.
Five of the management team including the general manager and quality supervisor were dismissed for their roles. Another five were given a "serious demerit," Zhang said. The director and vice director of the food and drug bureau of Fuyang received administrative penalties.
Zhang said the "Xinfu" incident had revealed "glaring problems" among China's drug manufacturers and "deficient supervision" by the authorities. "Companies should think very seriously about this catastrophe, run their businesses honestly and stick to the law," he added.
He urged local drug watchdogs to remove supervision loopholes and draw up a list of companies requiring special surveillance.
The national drug watchdog strongly recommended that local authorities adopt the practice of making unannounced inspections on manufacturers designed to catch potentially problematic companies red-handed.
At the end of September the administration carried out 35 unannounced inspections of drug manufacturers. As a result 15 companies had their GMP revoked and another 13 were ordered to rectify production defects. The issue of GMP certificates to seven other drug producers was postponed, Zhang said.
He added that all new drugs must receive on-the-spot inspection before being marketed. "Investigators will go to plants to see laboratory tests at first hand, inspect clinical records, sample products and make sure they are consistent with the materials that figure in the application," Zhang said. "Falsification will be severely punished in line with the law," he warned.
(China Daily October 17, 2006)