China punishes manufactuer of suspect killer antibiotic

(Xinhua)
Updated: 2006-10-16 14:31

BEIJING -- China's national drug watchdog has revoked Anhui Huayuan Worldbest Biology Pharmacy Co.'s production license for injections and dismissed the company's top management.

The manufacture of "Xinfu" drugs, which allegedly caused six deaths in the country in July, is banned, spokesman Zhang Jixiang with the State Food and Drug Administration said here on Monday.

He said that the "Xinfu" antibiotic injection was of inferior quality. The company's Good Manufacturing Practice Certificate and its production license for "Xinfu" drugs have been revoked.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 China's Drug Management Law, Zhang said.

Five management staff including general manager Qiu Zuyi, executive deputy general manager Zhou Cang, deputy general manager Pan Wei, Plant II director Yuan Haiyuan and quality supervisor Cui Tongxin were dismissed for their responsibility in respect to the suspect killer antibiotic.

Another five people including legal representative Sun Ying, production director Liu Jiansong, Plant II vice directors Jia Yibo and Wang Dianlin and technician Chen Ping each were given a "serious demerit", Zhang said.

Director Zhang Guodong and vice director Shang Wenxue of the Food and Drug Bureau of Fuyang City received administrative sanctions.

Zhang said that the "Xinfu" incident had unveiled "glaring problems" among China's drug manufacturers and "deficient supervision" by drug authorities.

"Companies should think very seriously about this catastrophe, run their business honestly and stick to the law," Zhang said.

He urged local drug watchdogs to ferret out supervision loopholes and make a list of companies that require special surveillance.

The national drug watchdog strongly recommended that local authorities adopt the practice of making sudden unannounced inspections, intended to catch problematic companies red-handed.

At the end of September, the administration had carried out 35 unannounced inspections of drug manufacturers. As a result, fifteen companies have had their Good Manufacturing Practice (GMP) Certificates revoked and another 13 were ordered to rectify production defects.

The issuance of GMP certificates to seven other drug producers was postponed, Zhang said.

He said 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.

The administration also tightened up technology criteria concerning the production of risky medicines, particularly injections, to better defend the lives and interests of patients, he said.