China's drug administration has revoked the production license of the Shanghai Hualian Pharmaceutical Co. after it produced contaminated leukemia drugs, the spokeswoman of the State Food and Drug Administration (SFDA) said here Wednesday.
Yan Jiangying said at a press conference that the SFDA's Shanghai branch has revoked the company's production license and confiscated the money made from the problem drugs.
The producer will also be fined to the highest amount allowed by the drug law, he said. No specific figure was given.
According to Yan, the SFDA and the Ministry of Health (MOH) jointly set up an investigation group after the case was revealed.
"However, leaders of the Shanghai Hualian Pharmaceutical Company intentionally held back the facts of production violations during the investigation," Yan said.
"Relevant responsible people of the company have been detained by police," Yan said.
The SFDA and the Ministry of Health (MOH) suspended production, sale and usage of methotrexate and cytarabin hydrochloride, two drugs made by the company, on Sept. 5.
It made the decision after the National Center for Adverse Drug Reaction Monitoring reported that the drugs had caused adverse reactions, including difficulty in walking and urine retention, in some leukaemia patients in Shanghai, Guangxi, Beijing, Anhui, Hebei, Henan and other regions.
The case came into spotlight as early as July this year as several child leukaemia victims in three hospitals in Guangxi Zhuang Autonomous Region and Shanghai developed pain in their legs and some had difficulty walking after being injected with the methotrexate drug.
On Sept. 14, the MOH and the SFDA said in a joint notice that investigations revealed that the incidents happened because several batches of the two drugs had been contaminated by vincristine sulphate, an anti-cancer medicine, during production.
The Shanghai municipal government said on Sept. 15 that "most" of the suspect drugs had been recalled and the relevant agencies had traced the whereabouts of the rest.
Yan, the spokeswoman, failed to reveal how many people were affected by the contaminated drugs. But some media report has put the number of victims at "several hundreds."
The Shanghai-based company was planning compensation to victims of its contaminated leukaemia drugs, and the relevant work was underway, according to Yan.
(Xinhua News Agency December 13, 2007)
