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Ministry of Health, Labor and Welfare on-site inspection, unusual scale
December 22, 2020 7:20 am
Toru Tanaka, Manager of the Drug Monitoring and Orientation and Countermeasures Division of the Ministry of Health, Labor and Welfare (right) = 10:05 am on December 21, Yachi, Awara City, Fukui Prefecture, answering questions from the press
Kobayashi Kako (Headquarters: Awara City, Fukui Prefecture) The problem was that a component of a sleep-inducing agent was mixed into a therapeutic drug such as the nailworms made by Kobayashi Kako. “It is impossible to mix sleeping pills. We take it as a problem for the generic (generic) drug industry and the pharmaceutical industry as a whole,” he said, and said that he takes seriously the situation of damage to health.
⇒[Serie D]Follow the process of mixing sleeping pills
The number of people who entered the Kobayashi Kako headquarters while it was snowing was 13 from the Fukui Prefectural Ministry of Health, Labor and Welfare and the Pharmaceutical and Medical Device Organization (PMDA), which is said to be a exceptional scale. Surrounded by a large number of journalists, Mr. Tanaka said: “There is a lot of damage to health. I have told you to collect every last tablet.”
The prefecture visited the factory on the 9th to investigate the contamination. From the report, it is said that there were cases where even items other than the three types of itraconazole “MEEK” tablets, which were deemed to be unapproved processes and were collected voluntarily, violated the Pharmaceutical and Medical Devices Act. He also pointed out that “Itraconazole Tablets 100 and 200 had a process that was not approved, which was different from the addition of raw materials,” and he showed an attitude to proceed with the detailed investigation.
As for a woman in her 70s who died while being admitted to a metropolitan area hospital after taking the tablet in question, “I have not heard of a causal relationship at this time (the company may have a causal relationship with taking it . Unknown, including the second case. We are investigating. “
The results of the survey are said to be finalized at the beginning of the year. “The details of the arrangement, such as the suspension of the business and how many days it will take, are yet to come.” The inquiries were made by the Institute of Chemistry and (and) the Serum Therapy Research Institute (Chemical Research Institute, Kumamoto City), which was ordered to suspend operations for 110 days in 2016 for the manufacture of preparations blood by a method other than national approval. It is an example of. “I don’t know if it’s the same or better, but it’s a pretty harsh punishment,” he said.
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