Novartis, a giant of pharmaceutical companies located in Switzerland, has been ordered to suspend its operations in Japan, when it failed to provide the appropriate side-effects of the various kinds of drugs. According to the health Ministry of Japan, this is actually a grave injustice, and not at all in accordance to the food and drug authority of Japan. So, this is actually a first for any pharmaceutical company that has been operating in Japan. They have been ordered a 15 day suspension, and the company will not be able to sell most of its drugs in the Japanese territory. This suspension would start from 5 March, 2015.
According to the rules and regulations of Japan, the companies that are dealing with drugs, would have to maintain a very serious understanding about the side-effects that are to accompany any of the drugs that they are selling. It needs to be reported to the Ministry within 15 to 30 days of the product coming to the market. However, any sort of insolence in such regards will not be tolerated by the Japanese government. So, when Novartis, was handed an improvement order, there were unable to meet the standards of this particular regulation.
They have since then, failed in order to provide the appropriate amount of side-effects on the drugs that they are selling, and the Japanese government has been able to take the appropriate action. They are justified in their cause, and this is actually led to a lot of problems for the pharmaceutical giant. So, the main problem lies with reporting the side-effects of two drugs that can help cure leukaemia. The prosecutors have actually mentioned that a lot of falsified data was used in that particular medication to ensure that it could exaggerate all the benefits of the blood-pressure drug found within that particular unit. So, in order to test the claims, the Japanese government had asked for a notable list of side effects. However, the inability to do so has actually led to Novartis not being able to sell drugs in the coming fortnight.
The Japanese government has also indicted Nobuo Shirahashi, a former employee of the Novartis Company, within the Japanese unit. He has been accused of tampering and manipulating the data that is to be found in the clinical studies, when marketing the drug also known as Diovan/ Valsartan.
Novartis had admitted in the December 2014 that they had been guilty of not providing any sort of reports about 3000 cases of adverse effects that were to be found from about two dozen companies’ drugs. This was definitely a lapse in their judgement, and they did not understand the harsh reality that would be staring at them. Now, after the judgement has been passed, this is definitely something that would end up creating a dent in the different kinds of revenue streams that Novartis would have actually had from the people in Japan.
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