Last year, two generic drug manufacturers found manufacturing problems and fraud, and after a series of business suspension orders were issued, industry groups proceeded with voluntary inspections of the manufacturing conditions of each company. It was announced that 31 companies, which is 80%, found processes that differed from the procedures approved by the government.
Regarding generic drugs, due to manufacturing problems, "Kobayashi Kako" in Fukui Prefecture received an order to suspend operations in February last year, followed by a major "Nichi-Iko" in Toyama Prefecture in March.
In response to this, the industry group "Japan Generic Pharmaceutical Association" proceeded with a self-inspection of the manufacturing conditions of each company, and as a result, 31 of the 38 member companies accounted for more than 80% of the manufacturing, which is not stated in the national approval certificate. It means that the procedure etc. was found.
We found 1157 items, which is 15% of the total inspection target, and the group says that no new major problems such as efficacy and safety have been revealed.
In order to ensure that each company has a system that puts the highest priority on quality, the organization regularly conducts training to change the awareness of management, enhances the contact point for whistleblowing, and conducts external audits of major manufacturing plants every year. Our policy is to strengthen measures, such as once.
At a press conference held in Tokyo on the 24th, Mitsuo Sawai, chairman of the Japan Generic Pharmaceutical Association, said, "We apologize for the fact that the manufacturing problems of the two generic companies have caused a shortage of current drug supply. We will work on countermeasures with our unwavering determination to never cause manufacturing problems again. "
After the problems of the two manufacturers were discovered last year, the Ministry of Health, Labor and Welfare and prefectures strengthened inspections of the manufacturers, and manufacturers all over the country also discovered fraud and ordered to suspend operations one after another. The shortage of unprecedented supply of medicines at pharmacies and medical institutions has become an issue.