Systematic, company-wide improper manufacturing procedures and falsification of quality test results have been tolerated for many years at a pharmaceutical company, acts of outrageous betrayal for a firm that should be protecting people's lives.
Regarding the case in which antifungal medication to treat the nail fungal disease onychomycosis and other dermatological diseases was found to be tainted with a sleep-inducing component, the Fukui prefectural government has ordered the prefecture-based maker Kobayashi Kako Co. to suspend operations for 116 days. This is the longest business suspension order ever imposed on a pharmaceutical company in Japan under the Pharmaceuticals and Medical Devices Law.
More than 200 people, exceeding 70% of those who used the medicine in question, have complained of loss of consciousness and other health problems, and two have died. Considering the seriousness of the consequences, the punishment seem much too light.
As to how antifungal medication was tainted with a sleep-inducing component, it was revealed that employees at the drug manufacturer had violated the procedures approved by the Health, Labor and Welfare Ministry, leading to the mixing of ingredients. A survey conducted later by the prefectural government newly confirmed many other violations, including those related to other drugs, which have been acknowledged by the company's senior executives.
Within the company, there existed an unauthorized "backstage manual" describing the manufacturing process. In some cases, the results of quality tests conducted before shipment were falsified. They are all irregularities relating to the safety of drugs, so one cannot help but be outraged.
Kobayashi Kako has made up fictitious production records for more than 70% of its products. It seems the cover-up hoped to prevent irregularities from coming to light in an administrative investigation.
It has been reported that such misconduct began around 2005, while the falsification of test results has been ongoing since the 1970s. Hiroyuki Kobayashi, president of the company, said at a press conference, "Our company prioritized work efficiency over rules." It is an outrageous and despicable act to make light of safety.
The president said that he knew the actual situation surrounding the misconduct from more than 10 years ago. Not only a third-party investigating committee but also the investigative authorities need to take a closer look at the cause of these actions, such as whether senior executives directed employees to commit the misconduct.
Kobayashi Kako has improved its business performance with inexpensive generic drugs. The company has increased the number of employees in line with its rapid growth, but its responsibility not to provide employees with sufficient guidance regarding knowledge and skills is grave.
The use of generic drugs is increasing as the government promotes their spread on the grounds of reducing medical costs. The misconduct this time could shake from the very roots the trust the government and private sector have accumulated. Kobayashi Kako cannot escape harsh criticism.
There are also points on the administrative side that need to be reviewed. The prefectural government has conducted on-site inspections several times a year, but failed to detect any wrongdoing. The prefectural government should have responded strictly to Kobayashi Kako because the company has so far repeatedly recalled its products on a voluntary basis.
It is urgent to restore confidence in the industry. It is necessary for each company to reexamine their drug manufacturing processes and other management practices, and for administrators to strengthen their capabilities for oversight through such measures as conducting unannounced inspections.
-- The original Japanese article appeared in The Yomiuri Shimbun on Feb. 11, 2021.
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