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    Home > Active Ingredient News > Drugs Articles > The monitoring of traditional Chinese medicine injection is tightening or hundreds of manufacturers are facing bankruptcy

    The monitoring of traditional Chinese medicine injection is tightening or hundreds of manufacturers are facing bankruptcy

    • Last Update: 2013-10-10
    • Source: Internet
    • Author: User
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    Source: time weekly for several months from October to October 2013, the event of "banning traditional Chinese medicine injection" in Beijing Chaoyang Hospital finally settled, but the debate about traditional Chinese medicine injection still hasn't been settled In fact, as a symbol of modernization of traditional Chinese medicine, the safety of traditional Chinese medicine injection has been questioned According to the public data, adverse reactions of traditional Chinese medicine injections were reported 103000 times in 2012 In contrast, the market scale of traditional Chinese medicine injection is expanding rapidly What is the safety of traditional Chinese medicine injection? What are the reasons behind its rapid expansion? The reporter tries to reduce the existing situation of traditional Chinese medicine injection by combing the development of traditional Chinese medicine injection The market scale of 30 billion yuan of traditional Chinese medicine injection has become the largest market share in the field of traditional Chinese medicine In the market share of cardio cerebrovascular and anti-tumor Chinese patent medicine, the top 10 products account for 7 seats in total There are more than 50 kinds of commonly used traditional Chinese medicine injections, with an overall market scale of 25-30 billion yuan In recent five years, the compound growth rate is about 21%, which is significantly higher than the income growth rate of 15.78% of proprietary Chinese medicine and 18.23% of the whole drug market According to the data of the State Food and drug administration, at present, the number of drugs produced by domestic pharmaceutical enterprises is up to more than 160000, while the number of traditional Chinese medicine is close to 60000, while the number of traditional Chinese medicine injections is no more than 140, only about 150 pharmaceutical enterprises are engaged in the production of traditional Chinese medicine injections Various listed pharmaceutical companies also rely on the traditional Chinese medicine injection business to varying degrees According to the situation of Chinese medicine injection production enterprises that have published the mid-2013 report, Shanghai Kaibao Chinese medicine injection revenue accounts for 99% of the total revenue, which is the most concentrated enterprise in its industry; the proportion of Xueshuantong of Zhongheng group also reaches a high of 88%; the proportion of HongRi pharmaceutical and Kangyuan pharmaceutical in 2013 accounts for 64% and 55% In fact, among the 55 listed companies of traditional Chinese medicine, only the time-honored enterprises such as pianzehuang and Yunnan Baiyao, which have the exclusive heavy-duty varieties, and the enterprises mainly engaged in traditional Chinese medicine injection, can maintain an annual growth rate of more than 30% Under the guidance of traditional Chinese medicine theory and modern science and technology, the "danger zone" with frequent adverse reactions is called traditional Chinese medicine injection It was once regarded as the symbol of modernization of traditional Chinese medicine, but it has always been a contradictory complex It is understood that there are not a small number of voices advocating the total prohibition of traditional Chinese medicine injection In the past few years, there have been more and more accidents in traditional Chinese medicine injection In the event of Houttuynia cordata in 2006, several patients died directly after using the related injection; in 2008, three patients died of Ciwujia injection, and four newborns suffered from adverse reactions caused by Yinzhihuang injection, one of them died According to the 2012 annual ADR monitoring report issued by the State Food and drug administration, in 2012, the ADR monitoring network of China received 103 thousand ADR reports of 14 categories of traditional Chinese medicine injections, including more than 5500 serious reports, accounting for 5.3% Compared with 2011, the number of adverse reactions reported by traditional Chinese medicine injection increased by 58.2% year on year According to the reporter, the difference between traditional Chinese medicine injection and Western medicine lies in that traditional Chinese medicine is a multi-component formulation, which can exert its efficacy through multiple targets In the process of disease prevention and treatment, it can not only alleviate symptoms, but also enhance the resistance of the body, so that patients can get better recovery However, it is because of its numerous components that it is difficult to determine that it leads to frequent clinical adverse reactions A pharmaceutical expert told reporters that the composition of traditional Chinese medicine injections is complex and there may be various antigens that cause allergic reactions In addition, various additives, solubilizers, stabilizers and some impurities in their preparation are also easy to induce allergic reactions "It's all in the blood vessels The allergens should be consistent." The allergen of traditional Chinese medicine injection should be studied clearly, but not treated differently by non chemical drugs The embarrassing situation was criticized because of frequent adverse reactions At present, many hospitals hold a boycott attitude towards it Doctors of Guangzhou first and third class hospital admitted to reporters that the hospital has not used traditional Chinese medicine injection On the other hand, high profits drive the major pharmaceutical enterprises to increase investment in traditional Chinese medicine injection A person in a deep-rooted industry told reporters that compared with western medicine, the investment cost of traditional Chinese medicine and injection R & D companies is relatively low, so there is a large profit margin However, due to the uniqueness of traditional Chinese medicine injection, domestic enterprises have greater pricing power without facing the competition of foreign pharmaceutical enterprises In fact, the situation may not be as optimistic as it appears Zhou Fucheng, Deputy Secretary General of the national pharmacopoeia committee, said at the Chinese Pharmaceutical Conference that he would further strengthen the safety control of high-risk traditional Chinese medicine injections, and study and establish a new method for the examination of related substances such as abnormal toxicity, allergic reaction, polymer, protein and resin of traditional Chinese medicine injections The 2015 edition of Chinese Pharmacopoeia has been revised, because of safety issues, the regulatory control of traditional Chinese medicine injections is also tightening step by step For enterprises, it will be impacted After the Houttuynia event, the State Food and Drug Administration suspended the sale and use of seven kinds of related drugs After the suspension, many enterprises directly fell into the dilemma of return and production suspension due to their excessive dependence on traditional Chinese medicine injection business In the event of Houttuynia cordata, nearly 100 enterprises' production lines were in the state of shutdown and half production, more than 10 enterprises were directly on the verge of bankruptcy, with a loss of about 2 billion yuan Although traditional Chinese medicine injection has been in an awkward position, it plays an irreplaceable role in the field of cardiovascular and cerebrovascular diseases and tumor diseases Cardiovascular and cerebrovascular diseases also accounted for 58.1% of the total market value of traditional Chinese medicine injection When it comes to the issue of retention and waste of traditional Chinese medicine injections, the aforementioned pharmaceutical experts think that the market should be more rational.
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