BEIJING -- China's national drug watchdog on Tuesday cited substandard
disinfection as a major factor leading to the lethality of a suspect antibiotic
injection, which has allegedly killed six people.
The "Xinfu" drug manufactured in June and July by Anhui Huayuan Worldbest
Biology Pharmacy Co. wasn't sterilized properly, with both the sterilization
temperature and time below the state-required safety level, said China's State
Food and Drug Administration (SFDA).
"As required, the drug should go through a 30-minute disinfection process at
105 degrees Celsius. But the company lowered the temperature to 100 to 104
degrees Celsius and shortened the time to only one to four minutes," said Wang
Zhexiong, an official with the safety supervision department of the SFDA.
Disinfection cabinets were also overloaded with the injection, and thus could
not effectively wipe out bacteria,Wang said.
The administration promised to punish the company for its production faults
and held related producers and managers accountable, but gave no details.
The administration has sent out an investigation team to inspect the
pharmaceutical company in East China's Anhui Province. Test on the injection
sample conducted by the team has detected excessive bacteria.
Wang said further analysis is needed to find out what kinds of bacteria the
sample contains.
Earlier investigation results showed the company had produced 3.7 million
bottles of clindamycin phosphate glucose injection since June, with more than
3.18 million bottles sold in 26 provinces across China.
So far, more than 1.2 million bottles of the drug had been recalled, 173,007
were en route back to the factory, and more than 403,170 bottles had been
located and sealed up in other areas, said Zhang Jixiang, the administration's
spokesman.
He could not account for the whereabouts of the remainder of the drug.
Since the first report of the problematic injection on July 27, the drug is
blamed for killing six and causing illness to at least 80 people in 10 provinces
including Zhejiang, Heilongjiang, Hunan and Shandong.
Severe adverse reactions were reported among patients after taking the drug,
such as chest, kidney or stomach pains, vomiting and anaphylactic shock.
The Ministry of Health has demanded all provincial health departments report
cases of adverse reactions to the problematic drug by 4 p.m. each day.
Shao Mingli, director of the SFDA, said on Tuesday at a national work
conference that the antibiotic incident exposed a chaotic drug market and
loopholes in drug supervision work of the country.
