China will strengthen inspection over drug companies covered by
the certification system called Good Manufacturing Practice (GMP),
which was brought into disrepute by a series of health scares and
corruption scandals, said a senior drug watchdog official on
Tuesday.
Wu Zhen, deputy director of the State Food and Drug
Administration (SFDA), said the administration carried out numerous
unannounced inspections of drug manufacturers last year and
stripped 86 companies their GMP certificates.
"We will tighten the regular examinations of drug producers this
year," Wu said.
"GMP is a good system and problems were caused by the companies'
violations and a lack of supervision from the administration," Wu
said.
The GMP system was promoted by Zheng Xiaoyu, former director of
the SFDA, who is being investigated for abusing his position to
take bribes in exchange for ignoring drug approval regulation.
Under the system, companies must possess a GMP certificate
before they can register new medicines.
The most notorious case that hurt the credibility of GMP came to
light last July when "Xinfu" antibiotic injections, manufactured by
Anhui Huayuan Worldbest Biology Pharmacy Company, caused the deaths
of at least six patients and severe reactions in more than 80
others.
Last November one of Zheng Xiaoyu's directors at the SFDA, Hao
Heping, was sentenced to 15 years in prison for taking bribes.
Cao Wenzhuang, former director of the drug registration
department of the SFDA, was detained in Jan. 2006 on suspicion of
bribery.
(Xinhua News Agency February 28, 2007)