China's top drug watchdog has revoked the license of a Shanghai drug producer after its leukemia drugs were proven contaminated and caused serious adverse reactions in some patients.
The production license of the Shanghai Hualian Pharmaceutical Company has been annulled and police have already detained those responsible, Yan Jiangying, spokeswoman of the State Food and Drug Administration, told a news conference in Beijing yesterday.
Those responsible for the company had "systematically organized" a cover up for their mistakes during an investigation by the administration and the Ministry of Health, Yan said.
In July this year, several children in three hospitals in Shanghai and Guangxi Zhuang Autonomous Region developed pain in their legs and some had difficulty walking after being injected with methotrexate made by Hualian.
The administration and the health ministry suspended the production, sale and use of methotrexate and cytarabin hydrochloride, two drugs made by Hualian, on September 5 after the National Center for Adverse Drug Reaction Monitoring reported that the drugs had caused adverse reactions in leukemia patients in Shanghai, Guangxi, Beijing, Anhui, Hebei, Henan and other regions.
The ministry and the administration said the drugs were contaminated by vincristine sulfate, an anti-cancer medicine, during production.
Yan did not say how many were affected by the contaminated drugs but some media reports have put the number of victims at "several hundred."
All the earnings from the contaminated drugs will be seized while the company will suffer the harshest punishment available under the country's Drug Management Regulation, Yan said.
The regulation says that drug producers can be fined up to 30,000 yuan (US$4,065) if they breach the rules.
The Shanghai government said on September 15 that most of the suspect drugs had been recalled and the relevant agencies had located the remainder.
The city government has asked the Shanghai Pharmaceutical (Group), the parent of Hualian, to set up a fund to compensate victims of its contaminated leukemia drugs, Yan said.
She declined to reveal how much each victim could receive.
(Shanghai Daily December 13, 2007)