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Certificate and its production license for the drug had been
revoked.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)