Traditional Chinese medicine injection with unknown safety will face "life and death"

[China Pharmaceutical network industry trends] recently, the state health insurance bureau released the work plan for the adjustment of the national medical insurance drug catalog in 2019 (Draft for comments) The adjustment of the drug catalog involves three aspects: Western medicine, Chinese patent medicine and Chinese herbal pieces, specifically including drug transfer in and drug transfer out According to the arrangement, the new version of the regular access medical insurance drug catalog will be published in June, and all catalog drug adjustments will be completed in September After the announcement of the plan, the uneasiness in the market of traditional Chinese medicine injections has become more and more widespread According to the industry, with the drug safety issues mentioned, under the tightening policy of traditional Chinese medicine injection industry, those traditional Chinese medicine injections with unclear safety and lack of effective support of clinical data will face "life and death" In the era of drug shortage, traditional Chinese medicine injection was born Among them, bupleurum injection has become the first industrial production of traditional Chinese medicine injection in China With the rapid development of traditional Chinese medicine injections, the types of traditional Chinese medicine injections are also increasing Data shows that up to the 1980s, there were about 1400 kinds of traditional Chinese medicine injections in China However, with the wide use of traditional Chinese medicine injection and the continuous expansion of its scale, its adverse reactions and drug safety problems are increasingly prominent With the variety of traditional Chinese medicine injection, the adverse reactions increased year by year In 2006, 7 injections such as Houttuynia cordata injection were "stopped" due to frequent adverse events, which made the safety of traditional Chinese medicine injections cause doubts from all walks of life, and also affected the clinical application of traditional Chinese medicine injections In this context, the regulatory policy of traditional Chinese medicine injection industry is also tightening In the catalogue of drugs for national basic medical insurance, work injury insurance and maternity insurance (2017 Edition), 39 traditional Chinese medicine injections have strict limits on the scope of reimbursement, of which 26 large varieties commonly used in clinical use are used by medical institutions above level II From the national level to the local implementation, the use of traditional Chinese medicine injection has more strict restrictions, resulting in the industry no longer maintaining a steady growth According to the data, in 2017, the market size of injections sold by public medical institutions in China was 102.15 billion yuan, down 2.52% year on year At present, with the promotion of the drug catalog adjustment in 2019, many industries are worried that some products will be transferred out after the adjustment, which will bring a heavy blow to the traditional Chinese medicine injection industry, especially those enterprises that are mainly engaged in traditional Chinese medicine injection It is undeniable that the basic research of safety and effectiveness of traditional Chinese medicine injection is weak, which leads to the serious shortage of clinical effectiveness data and safety data, and there are many problems "The adjustment of the medical insurance catalogue aims to highlight the clinical value of drugs, and drug manufacturers with good clinical effect are expected to benefit from it In the process of bird exchange, those auxiliary drugs with unclear clinical effect will face a crisis." Some insiders have judged that after the new adjustment of the medical insurance catalogue, some traditional Chinese medicine injections that lack clinical effective data and whose safety is unclear may be eliminated In this context, although the traditional Chinese medicine injection industry will not be killed by "one stick", but for enterprises, how to survive is a big problem Although there are industry recommendations, safety evaluation can be started However, restricted by the process, cost, standard and other problems, many traditional Chinese medicine injection enterprises have no way to start at all It is difficult to re evaluate the safety of traditional Chinese medicine injection, and even some enterprises have no progress at present In general, it is inevitable for the traditional Chinese medicine injection industry to shuffle in the future, and it will face the situation of survival of the fittest.