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Japan pharma firm inspected over illegal drug production after deaths, injuries of users

Officials of the Ministry of Health, Labor and Welfare enter the offices of Kobayashi Kako Co. for an inspection, in Awara, Fukui Prefecture, on Dec. 21, 2020. (Mainichi/Sho Ohara)

FUKUI -- The Ministry of Health, Labor and Welfare and other authorities on Dec. 21 conducted an on-site inspection at Kobayashi Kako Co. in central Japan after it emerged that the drug maker adopted illegal manufacturing procedures for several drugs besides a skin medication laced with sleep-inducing substances given to two people who later died and others who suffered injuries.

    The health ministry, along with the Fukui Prefectural Government and other bodies, inspected the firm based in the city of Awara, Fukui Prefecture, on suspicion of violating the pharmaceuticals and medical devices act, and is investigating the case with an eye on issuing a business suspension order to the company.

    Kobayashi Kako has been voluntarily recalling a medication for skin conditions such as athletes' foot since Dec. 4. In addition to the drug, it turned out that the company produced several other drugs under procedures unauthorized by the health ministry. "It is a grave issue and we'll take strict measures," said the head of the health ministry's section in charge of the case.

    There have been numerous reports of health damage to people who took the oral antifungal agent "Itraconazole tablet 50 'MEEK,'" including the death of a woman in her 70s after taking the medication. It has been revealed that substances for the sleep-inducing drug Rilmazafone were mistakenly added to make up for shortages during the production process for the tablets. The health ministry does not authorize the addition of drug substances since such a procedure could result in uneven concentrations of substances in tablets.

    It later emerged that "Itraconazole tablet 100 'MEEK'" and "Itraconazole tablet 200 'MEEK'" -- the same drug but with a different content as the main component -- had also been produced in violation of state-authorized procedures. Although no substances for sleep-inducing drugs were detected in those two types of agents, the pharmaceutical maker also began to voluntarily recall the drugs on Dec. 7 due to the questionable production process.

    According to the health ministry, a subsequent investigation by the prefectural government uncovered that the company had produced several other drugs apart from the three types of Itraconazole tablets under procedures unauthorized by the ministry. Under the Act on Security Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, drug makers are required to create their own production protocols, keep records of those procedures and then inspect product quality based on those records before shipping them out, and such procedures must be approved by the health ministry.

    The latest on-site investigation is scheduled to span several days, with inspectors checking work records from the production process and questioning employees in order to reveal the cause of the blunder. The authorities will also investigate whether there was any issue with the safety management of all products manufactured at the same factory, including drugs that were newly found to have been produced under illegal procedures.

    Toru Tanaka, head of the health ministry's Compliance and Narcotics Division, who inspected the company's offices, said, "It is extremely serious as the issue concerns the pharmaceutical industry as a whole. It has been revealed that the company adopted unauthorized procedures for drugs other than Itraconazole. It is inevitable for the firm to be slapped with a business suspension order."

    Even though "Itraconazole tablet 50 'MEEK'" was the only drug found to be laced with substances for a sleep-inducing drug, it has turned out that the company had repeatedly violated laws and internal regulations during their production processes. Those contraventions include the failure to abide by an in-house rule for pairs to retrieve drug substances from storage spaces while pointing fingers to confirm procedures. The firm also failed to notice data suggesting contamination of foreign matter during a sample survey of the drugs in question before shipment.

    "Itraconazole tablet 50 'MEEK'" was prescribed to 364 people in Tokyo, Hokkaido and 29 other prefectures in Japan. Of them, 155 people have been confirmed to have suffered health issues, with 34 of them rushed to or admitted to hospitals. There were a total of 21 traffic accidents linked to the medication, including disturbance of consciousness apparently caused by ingestion of the drug.

    (Japanese original by Sho Ohara and Chika Yokomi, Fukui Bureau)

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