BEIJING, Dec. 12 (Xinhua) -- 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 has 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, however, 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.