Health authorities in south China's Guangdong Province have called on drugstores
and hospitals to withdraw potentially unsafe human-blood products
made by a local pharmaceutical company.
The call came after a notice jointly issued by the Ministry of
Health and the State Food and Drug Administration (SFDA) early on
Sunday indicated that Guangdong Bioyee Pharmaceutical Co Ltd had
"seriously" violated drug manufacturing rules in producing an
intravenously injected blood drug called "human-blood gamma
globulin."
"We'll be keeping a close watch on the sale and use of these
blood products in drugstores and hospitals following the release of
the notice," Yu Dewen, a spokesman for the Guangdong Provincial
Health Department, said in an interview with China Daily
yesterday.
Prior to the release of the SFDA's notice the Beijing health
bureau had asked hospitals and drugstores in the city to stop
selling and administering the drug after patients who'd been
treated with it reportedly suffered from "negative effects".
The SFDA's notice didn't say how the Guangdong-based company had
violated drug rules or what the "negative effects" resulting from
the drug's use were.
Huang Sui, an official with the Guangzhou Health Bureau, said
all hospitals in Guangdong's capital city had withdrawn the drug.
"We're also asking hospitals to keep records of patients who've
been treated with the drug," Huang said.
Meanwhile, health authorities in Shanghai collected 4,832
bottles of the drug, reported the Shanghai-based News
Evening yesterday.
The Guangdong Bioyee company is based in Guangdong's northern
city of Shaoguan. The SFDA granted the company a certificate for
good manufacturing products (GMP) for pharmaceutical items on
November 24 last year, the company's official website said.
However, the SFDA canceled the company's GMP certificate on
January 16 for serious violations of drug-manufacturing
regulations. The company also appeared on a blacklist in August
last year for illegally collecting human blood.
The company's website said they'd developed a large sales
network stretching across the country.
"So we're working with health authorities in other regions to
deal with the suspension of the company's drugs," Yu said.
Officials from the company refused to be interviewed
yesterday.
(China Daily January 24, 2007)