NATIONAL JAN. 09, 2016 – 02:51PM JST
Blood products and vaccine manufacturer Kaketsuken on Friday was ordered by the state to suspend business for 110 days, the longest penalty ever handed down under Japan’s pharmaceutical law, as the company was found to have been adding unauthorized ingredients to its products and falsifying records for four decades.
While Kaketsuken, formally known as the Chemo-Sero-Therapeutic Research Institute, will be forced to halt business from Jan 18 to May 6, the health ministry has decided that in order to avoid impacts on patients it will exclude from the order some blood products and vaccines that do not have substitutes.
In December, a third party investigation panel released a report concluding the Kumamoto-based institute began straying from authorized processes for producing its blood products from 1974, or possibly earlier, and started using additives that prevents blood from clotting. The panel also accused the institute of forging data to cover it up from at least 1995 onwards.
Founded in 1945, Kaketsuken holds roughly 30% of the domestic influenza vaccine market and also produces vaccines for hepatitis A and B and Japanese encephalitis among others.