China’s SFDA Cancels Drug Maker’s License Following Investigation Of Tainted Products
SHANGHAI – China’s State FDA withdrew Shanghai Hualian Pharmaceutical's drug production license because the company’s two leukemia drugs were found to be contaminated and caused considerable damage to patients, the drug safety watchdog announced at a Dec. 12 press conference in Beijing.
“Shanghai FDA has revoked the company’s production license and confiscated the money made from the problem drugs according to the order from SFDA,” Du Bing, Shanghai FDA spokesman told PharmAsia News.
Shanghai Hualian Pharmaceutical is a subsidiary of the Shanghai Pharmaceutical Group, the largest pharmaceutical group enterprise in China.
The sales and distribution of the two injection drugs, Methotrexate and Cytarabin Hydrochloride were halted after they were reported to cause leg pain and difficulty in walking in patients in Shanghai, Beijing, Guangxi province, Anhui province and other provinces by the National Center for Adverse Drug Reactions in July (PharmAsia News, July 17, 2007).
On Sept. 5, SFDA and the Ministry of Health ordered the company to stop producing and selling the two drugs and recalled them from the market.
Further investigation led by SFDA and the Ministry of Health revealed that the drugs were contaminated by Vincristine Sulfate, an anti-cancer chemical.
“The leaders of the Shanghai Hualian Pharmaceutical Company intentionally held back the facts of production violations during the investigation,” SFDA Spokeswoman Yan Jiangying said at the press conference.
“Relevant responsible people of the company have been detained by police,” added Yan.
Illegal earnings from the contaminated drugs will be seized, and the company will be fined up to 30,000 yuan ($4,065), according to the drug management regulation.
“The compensation work is already underway and we will compensate the patients according to the law,” an officer in the compensation work group of SPGC told PharmAsia News.
However, she declined to give the number of victims.
“The accident will have a big impact on SPGC as Hualian is an important part of it,” Wang Youhong, an analyst in Shanghai-based Haitong Securities Company, told PharmAsia News. “Getting to keep the drug certifications will be the best result for SPGC.”
– Dai Jialing (pharmasia@elsevier.com)
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