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    Home > Active Ingredient News > Drugs Articles > The API has been recalled worldwide for the 2018 knockout phase-out of Generics in China

    The API has been recalled worldwide for the 2018 knockout phase-out of Generics in China

    • Last Update: 2021-02-09
    • Source: Internet
    • Author: User
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    Changchun Changsheng biological "problem vaccine" incident touched the sensitive nerves of the general public, a wave after wave, Huahai Pharmaceuticals to China's pharmaceutical credibility brought a heavy blow.
    recently, 22 countries and territories recalled a variety of commonly used drugs to control high blood pressure and prevent heart failure. The recall issued by the European Union directly points out that the source of the problem is Valsartan, a raw material produced in Huahai, Zhejiang Province.
    is this API "wanted" by the world overnight? What harm does this drug do?Wanted" raw material drug
    China's Zhejiang Huahai Pharmaceutical Factory made of salatin antihypertensive drugs should have brought hope to patients with high blood pressure, did not expect to be infected with N-nitrodiamine (NDMA) and the world wanted.
    , invented by Novarma Pharmaceuticals, is primarily used to treat high blood pressure, reduce the incidence of heart disease and stroke, and can be used to treat recent heart attacks and heart failure. In 2012, with the expiration of the patent, countries ushered in a wave of imitation, China's salatan imitation is also feng shui. To date, 11 companies approved by the CFDA, including Zhejiang Huahai Pharmaceutical Co., Ltd., have been able to produce raw materials for pyridostam.
    , however, during a recent routine monitoring exercise, the European Medicines Agency found that a generic nirtan from Huahai Pharmaceuticals in Zhejiang province contained A deadly carcinogen, N-nitrodylamide NDMA.
    NDMA, which was detected in the raw material for psalma, proved to be a possible carcinogen from animal studies and was classified as a Class 2A carcinogen by the World Health Organization's International Agency for Research on Cancer.
    the European Medicines Agency's EMA bulletin states that the NDMA should not have occurred in the Pysaltam, which may have been caused by changes in the manufacturing process, and that process changes after 2012 are likely to have been caused by the by-product NDMA.standard of consistent evaluation
    in theory, whether it is a generic drug of raw materials or a generic drug taken directly by a patient, the ability of the drug should be completely consistent with the original drug. But in practice, because the production process of the original drug is confidential, generic drugs want to "copy operation" is not so easy.
    , different chemical reactions can get the same results, the original drug went one, the generic drug went the other. Coupled with the differences in accessories, resulting in the purity of generic drugs, impurities, and even the effectiveness of drugs, there is a gap with the original drug.
    , how can the quality of generic drugs be monitored? Who controls the errity of generic drugs? This has to refer to China's drug evaluation standards.
    past, the lack of medical treatment in China, in line with the principle of allowing people to have medicines to eat, drug review standards set very low, the quality of generic drugs on the market is uneven. Sun Xinsheng, vice president of the China Pharmaceutical Quality Management Association, has said that each imitation brings about a 20% accumulation of errors, and eventually the lower the imitation, the farther away from the original drug effect.
    this time, the state proposed to carry out the evaluation of the consistency of generic drugs. That is, for generic drugs that have been approved for market, according to the principle of consistency with the quality and efficacy of the original drug, the quality consistency evaluation should be carried out in phases, and the generic drug should reach the level consistent with the original drug in terms of quality and efficacy.Consistency evaluation process
    it is not easy to produce the same high-tech content and high-quality drugs through consistent evaluation, which puts forward higher requirements for the technical capabilities and financial strength of enterprises, only the leading enterprises in the industry can meet the above conditions at the same time. Even generics from some well-known pharmaceutical companies have failed to pass China's consistent evaluation.
    2018
    with the development of consistent evaluation, the pattern of China's generic drug industry will also be significantly changed.
    2016, the General Office of the State Council issued the Opinions on the Conduct of Consistent Evaluation of the Quality and Efficacy of Generic Drugs (hereinafter referred to as Opinions), which set a time limit for the completion of conformity evaluation of domestic generic drugs. According to the requirements, the oral solid preparation varieties of generic chemicals approved for sale in the National Essential Medicines Directory (2012 edition) by October 2007 must complete a consistent evaluation by the end of 2018 and, if not passed, directly cancel the drug approval number.
    according to the latest information released by the approval center of the Drug Administration, there are currently four batches of 41 product regulations through generic drug consistency evaluation. However, only 11 of the 289 base drug catalogues. With the 2018 season set to come, it also means that tens of thousands of approvals could be at risk of being phased out by the end of the year.
    in addition to the pressure to be eliminated, even if the drug has been evaluated consistently, in clinical use, the decision is still in the clinician. In clinical applications, some doctors have expressed direct distrust of the efficacy of generic drugs. Up to the hospital level, after the abolition of drug addition, there is no profit difference between the original research drug and generic drugs, hospitals naturally tend to choose more assured drugs. the alternative to generic drugs
    Although generics do not have a good path to replace the original drug, it is clear that the end of the generic drug will achieve a large-scale replacement of the original drug.
    In order to stimulate the consistent evaluation of generic drugs, the Opinion mentions that generic drugs evaluated by consistency will receive preferential treatment and support in the areas of tender procurement, drug pricing, medical insurance payments and industrial funds, and medical institutions should give priority to procurement and clinical selection. It can be said that the national level has given a large framework.
    although the health insurance payment policy is still in the pipeline, but in the provinces that do not have a new round of provincial centralized tender procurement plan, has been introduced the provincial recruitment and access support policy.
    Lai Shiqing, Inspector of the Institutional Reform Department of the National Health and Health Commission, also pointed out, "We want to put forward clearly that the purpose of imitation is to replace." Generic drug substitution is both an international rule and practice and a requirement of Article 20 of the Office of the State (2018) (Opinion on Reforming and Improving the Policy for the Supply and Use of Generic Drugs).
    but the premise of all this is that generic drug companies do solid products, so that products in the safety, effectiveness, cost-effective and other indicators, no less than the original pharmaceutical enterprises. (Health)
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