It's been concluded by investigators that the deaths blamed on the use of an antibiotic were caused by "substandard disinfection" during the manufacturing process, the State Food and Drug Administration (SFDA) said yesterday.
SFDA has punished those responsible for the mistakes, Xinhua News Agency said, without identifying them or saying what penalties were handed out.
According to the results of the investigation the drug wasn't sterilized properly with both the sterilization temperature and duration below the state standard, said SFDA.
"The drug should go through a 30-minute disinfection process at 105°C but the company lowered the temperature to 100-104°C and shortened the time to only one to four minutes," said Wang Zhexiong, an official with SFDA's safety supervision department.
Disinfection cabinets were also overloaded and thus could not effectively destroy any bacteria, Wang added.
Last month the government ordered a recall of batches of the drug made by Huayuan Worldbest Biology Pharmacy Co Ltd in east China's Anhui Province after a six-year-old girl died. SFDA later blamed the drug, clindamycin phosphate glucose, for at least five other deaths.
Media reports said at least 10 people died after receiving the drug, which is used to treat bacterial infections.
Approximately 80 patients in 10 provinces including Zhejiang, Heilongjiang, Hunan and Shandong who received the drug suffered symptoms ranging from diarrhea and nausea to kidney pains and shock, according to reports.
Investigators earlier said they were looking into possible bacterial contamination of the drug, ruling out other factors. Tests done by the SFDA team at the company detected excessive bacteria. Wang said further analysis was needed to discover what types of bacteria the sample contained.
The company produced 3.7 million bottles of the drug since June with more than 3.18 million having been sold in 26 provinces. So far more than 1.2 million bottles have been recalled, 173,000 are on their way back to the factory and more than 403,000 located and sealed, said Zhang Jixiang, SFDA's spokesman.
Sun Lei, an official in charge of market supervision with SFDA, said the remaining bottles might have been used or scattered in hospitals, clinics and drugstores in small cities and remote rural areas, making them difficult to retrieve. SFDA will continue to "comb every corner" and "trace every single bottle," he said.
Shao Mingli, SFDA's director, said yesterday that the incident exposed a lack of proper controls in the drug market and loopholes in supervision. SFDA, along with other departments, will soon launch a one-year national campaign to regulate the drug market.
(China Daily August 16, 2006)