On December 14th, policy analyst Ishikawa Kazuo appeared on the Nippon Broadcasting System podcast program he hosts, “Ishikawa Kazuo’s Policy Literacy.” On November 21st, he discussed with experts the findings of an industry group survey that revealed that approximately 40% of generic drugs were manufactured in a manner that differed from the manufacturing and sales approval documents. By November 21, the Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ) had published the results of voluntary inspections of manufacturing practices conducted by all 172 companies dealing in generic drugs. It was found that of the 8,734 items, 3,796 items (more than 40%) were manufactured in a manner that differed from the manufacturing and sales approval. The Japan Pharmaceutical Manufacturers Association reported these figures as preliminary figures at a meeting of the Ministry of Health, Labor and Welfare, stating that “there is no impact on quality or safety,” but some meeting members called the figures “shocking” and strongly urged the prevention of recurrence. A series of quality irregularities have been uncovered in generic drugs, which account for approximately 80% of all prescription drugs (by value), and since 2021, 21 companies, including Kobayashi Pharmaceutical (Fukui Prefecture) and Nichi-Iko Pharmaceutical (Toyama Prefecture), have received administrative sanctions such as business suspension, which is also a contributing factor to the pharmaceutical supply shortage. Hiroyuki Sakamaki, a senior follower at Kanagawa Prefectural University of Health and Welfare and representative director of the general incorporated association p-cubed, who appeared as a guest on the program, explained the background to these developments, saying, “There are various reasons, but one example is the background to the government’s appeal to promote the use of generic drugs. “Some companies that had previously produced 100,000 tablets (of generic drugs) per year changed the way they produced them (in accordance with the manufacturing and sales approval) when they had to scale up to produce 10 million tablets,” he pointed out. On the other hand, he said, “Japan’s standards are too strict in some areas,” and added, “For example, when putting raw materials into a tank to manufacture a drug, the manufacturing and sales approval specifies whether they should be put in all at once or in small amounts. The results of this investigation did reveal some cases where there were errors in this area, but from the perspective of pharmaceutical experts, they do not seem to affect the effectiveness of the drug.” He revealed that Japan’s pharmaceutical standards are too strict, saying, “In the United States and Europe, things like how much (ingredients) should be included in the standards are not included.” He also said, “Japan’s regulations are so strict that a number of foreign companies are essentially withdrawing from Japan.” On top of that, as a solution to the problem of around 20% of the medicines needed by medical facilities not being supplied even now, he said, “Various factors are involved, but for example, when we look at the situation overseas, we can see how much of an impact it has on the human body. Even if the product is actually made using a process that differs from that originally submitted (manufacturing and sales approval), the decision could be made to prioritize a stable supply after evaluating the effects on the human body.” “Many of the drugs that are actually experiencing supply shortages are low-priced. “The government should take a good look at the data and implement pricing policies that make cheap products profitable or provide an incentive to increase production,” he said. “I want the government to implement policies that balance both prices and supply stability,” Ishikawa said. I would like to see the rationalization of regulations and a review of the rules,” he said. [Nippon Broadcasting System] 2024/12/14 (Sat) 9:00.
>>1 What? There have been cases of people dying from fraudulent generic drugs How can the standards be too strict (seriously) Are you stupid? Are you a Minoru Card user?
There are some generic drugs that are in the red the more they are made
Raw material and labor costs are rising, but drug prices are falling You might be told to just stop making them, but there are people who need the drug, so they can’t stop If multiple companies are making a drug and they’re the last one left, they can’t stop, so even if they’re in the black now, they look ahead and stop production early if they think they’re going to be in the red And then the overall supply of drugs decreases, and they get criticized They’re pretty stuck.
If you choose the original drug when there is a generic version available, it’s fine if it’s not covered by insurance. We need to somehow reduce the burden on the national treasury for medical expenses.
After taking a generic version of Xyzal I got a headache and palpitations, so I went to the pharmacy, but they told me they hadn’t reported any such incidents. It’s because there are pharmacies that ignore the facts that this practice is allowed to run wild.
>It doesn’t affect the effectiveness of the medicine. If that’s really the case, they should just get the approval again with the “put them all together” procedure. Don’t blame the system for laziness or the result of cutting corners. That’s probably why they mixed sleeping pills into the athlete’s foot medicine.
This drug is too strict. If you want to be lenient, stop using generics, remove it from the medical drug list, and don’t make it covered by insurance. Are you trying to kill me?
Regardless of the amount of effective drug, if the balance of excipients such as starch for molding is wrong, it’s a manufacturing defect. Anything can be called a manufacturing defect, but it doesn’t cause any harm to health.
Comments