The owners of the firm that produced the ciwujia herbal injections that caused the deaths of three people in Yunnan province last month could face criminal charges, the spokeswoman for the State Food and Drug Administration (SFDA) said on Thursday.
Speaking at a press conference in Beijing, Yan Jiangying said the factory operated by Wandashan Pharmaceutical Co in Heilongjiang had been shut down pending the results of an investigation by the provincial drugs agency.
Yan Jiangying, the spokeswoman for the State Food and Drug Administration (SFDA), was spepaking at a press conference. [China.org.cn]
The firm has already been stripped of its GMP (good manufacturing practices) certificate, she said.
Three people died and three others suffered adverse reactions after being injected with a herbal remedy manufactured by Wandashan. The product contained ciwujia (also known as Siberian ginseng), which is used to treat thrombosis and heart disease.
No new cases have been reported since last month, Yan said.
Following an investigation, the SFDA found that the harmful injections were part of a batch that had been contaminated when the company's warehouse in Kunming, capital of Yunnan, was flooded in July, she said.
But instead of disposing of the damaged goods, salespeople with the firm simply replaced the labels and put them on the market, she said.
"This shows the Wandashan company has serious loopholes in its monitoring system," Yan said.
"The firm was negligent in its monitoring of drug quality, and broke the law on quality supervision."
Following the fatal injections, on Oct 11, the SFDA confiscated 4,547 bottles of the drug, the Xinhua News Agency reported on Thursday.
The medicine had been sold to 53 drug stores and 92 hospitals across the country, and more than 43,000 ciwujia injections had been given, the report said.
The owners of the company have been banned from engaging in the production or sale of drugs for the next 10 years, Yan said.
They could yet face further, criminal charges, she said.
One of the company's sales staff, a man surnamed Zhang, who sold bottles of the contaminated drug has been detained by police, Yan said.
He and other members of the firm's sales team might also face criminal charges, she said.
The SFDA is currently looking at ways to improve the supervision of drugs in a bid to avoid similar cases happening in the future, Yan said.
However, she denied reports that a contaminated pneumonia and meningitis vaccine made by a firm from Yunnan had caused the death of a 4-month-old infant in Shandong last month.
The head of the hospital in which the baby died was sacked for misconduct, local media reported earlier.
Meanwhile, the SFDA Thursday issued tighter controls on the manufacture and sale of ephedrine, a common flu remedy that can be used to make the methamphetamine "ice".
The rules limit the number of packets of ephedrine domestic firms can sell, and prohibit them from making the drug for foreign clients, the agency said.
(China Daily November 7, 2008)