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"Xinfu" drugs have been revoked.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.
