Japan drugmaker hit with longest-ever suspension over violations
Publish- February 09, 2021, 11:18 PM
Kyodo/UNB - Kyodo/UNB
Hiroyuki Kobayashi, president of drugmaker Kobayashi Kako Co., apologizes after receiving business suspension order for legal violations at a press conference in Awara, Fukui Prefecture, on Feb. 9, 2021. (Kyodo)
A Japanese drugmaker was ordered Tuesday to suspend its business for 116 days, the longest such order ever imposed on a pharmaceutical company in the country, after systematically making up fictitious production records on nearly 80 percent of its 500 products.
The order for Kobayashi Kako Co. will be effective from Wednesday through June 5, said the Fukui prefectural government, which authorizes the generic drug maker in Awara to produce and sell medicines. The company was also found to have skipped preshipment quality tests for some products since the late 1970s and forged results, among other legal violations.
Kobayashi Kako came under scrutiny late last year after announcing it would recall antifungal medicine tainted with a sleep-inducing component, with adverse health effects reported in a dozen cases. The health ministry later conducted an on-site investigation of the company based in the central Japan prefecture.
Authorities now believe the drug maker's sloppy manufacturing controls resulted in the component being mixed into the oral antifungal medicine in June.
The number of consumers affected by the incident later increased. A total of 239 people, about 70 percent of those who took the drug, had adverse health effects, including impaired consciousness, while two people, in their 70s and 80s, died, according to the company.