A Chinese drug safety watchdog has halted all production at the Wandashan Pharmaceutical Company in northeast China's Heilongjiang Province after it sold contaminated drugs.
At a press conference on Thursday, the State Food and Drug Administration (SFDA) said Wandashan was the manufacturer of an herbal injection suspected of causing three deaths last month.
"This is a serious incident caused by drug contamination," said Yan Jiangying, SFDA spokeswoman.
The herbal injection product, known as ciwujia, was soaked by rain while in storage and thus contaminated by bacteria. It happened in Kunming, capital of southwest China's Yunnan Province, during a storm on July 1 of this year, Yan said.
The Wandashan Pharmaceutical Company's salesperson in Yunnan, surnamed Zhang, sold the contaminated products after changing packaging with new labels forwarded by the company.
"The company's action seriously violated the drug management law and it should be punished for producing the drug," Yan added.
She went on to say, the incident reflected the serious deficiency in the company's management of packages and labels and its managerial staff's low awareness of quality control.
The SFDA took away the company's certificate of Good Manufacturing Practice (GMP). It might also revoke its drug production license which would mean it could not re-open.
The SFDA also has prohibited those responsible from being engaged in drug production and distribution activities for ten years. It did not, however, identify those people.
Police in Yunan have detained several Wandashan employees including the salesperson, surnamed Zhang, according to Yan.
Six patients in southwest China’s Yunnan Province experienced adverse reactions after receiving a ciwujia injection. Their symptoms included vomiting and becoming comatose. Three patients died, according to a report released on October 6. The SFDA said no one has gotten sick since then.
The medicine is extracted from ciwujia, a type of Siberian ginseng. Injections are often used to treat thrombosis caused by a weak liver and kidneys. It is also believed to be helpful in treating coronary heart disease, nervous exhaustion and menopausal problems.
Ciwujia was a major ingredient used in Wandashan drugs. It made ten different kinds of products with it.
With fixed assets of 360 million yuan (about US$52.77 million), Wandashan Pharmaceutical's total sales value reached nearly 100 million yuan in 2007.
The company has more than 570 staff and has manufactured ciwujia for more than 30 years.
The SFDA has ordered nationwide recalls or confiscations of the drug.
October 11, 4,547 bottles of the herbal injection had been seized, SFDA figures showed. No updated numbers have been released since then, although Xinhua has asked for them.
The contaminated medicine was sold to 53 drug stores and 92 hospitals in 16 provinces, autonomous regions and municipalities, according to the SFDA.
In total, 43,383 ciwujia injections had been used.
(Xinhua News Agency November 7, 2008)