Can traditional Chinese medicine injection be reborn?

< br / > < br / > a few days ago, a notice on submitting the data related to the purchase of drugs with concentrated volume at the provincial level in 2020 issued by Qinghai Medical Security Bureau (qhmb [2020] No67) was circulated in the industryAccording to the notice, Tanreqing, Xueshuantong, Xuesaitong, Xiyanping, Salvia miltiorrhiza polyphenolate and other traditional Chinese medicine injections will be included in Qinghai provincial volume procurementIn recent years, the clinical use of traditional Chinese medicine injections is controversial, with a high rate of adverse reactions, and some provinces have listed them in the key monitoring directory, and the industry also has a mixed phenomenonHowever, in the novel coronavirus pneumonia outbreak, Xi Yan Ping, Xuebijing and Tanreqing injection were included in the national treatment planAfter the "baptism" of the epidemic situation, can the traditional Chinese medicine injection be brought into the opportunity of volume purchase to realize "Nirvana rebirth"? < br / > reviewing the development of traditional Chinese medicine injection industry in the past 20 years, it can be said that it has gone through a road of "low opening and high walking, high disk falling"< br / > SHEN Yong, chairman of Beijing shengshikanglai traditional Chinese medicine marketing planning Co., Ltd., introduced that the development of traditional Chinese medicine injection reached its peak by 2015, and then disputes began to appear, such as side effects, abuse, medical insurance, etcAs a result, the regulatory authorities began to introduce policies to limit their clinical useFor example, in 2017, relevant departments issued policies such as "the use of traditional Chinese medicine injections is limited to hospitals above level 2" and "specific requirements for some injections with limited use of diseases", which led to the gradual contraction of traditional Chinese medicine injection Market< br / > in recent years, the development of traditional Chinese medicine injection industry has been greatly hindered by the influence of policies and its own problemsShen Yong said that 99% of traditional Chinese medicine injections can only be used in hospitals above the second level due to the limited dosage form, so the dependence on policies is particularly strongIn addition, traditional Chinese medicine injection can not achieve export trade, and can not achieve overseas sales of traditional Chinese medicine products such as Banlangen Granules, Sanhuang tablets, Ejiao, etcLi Changcheng, a senior figure in the pharmaceutical industry, also said that quality complaints, adverse reactions, improper use and so on have made the development of traditional Chinese medicine injections in recent years meet with difficulties< br / > however, this time Qinghai province brought Tanreqing, Xueshuantong, Xuesaitong, Xiyanping, Danshen polyphenolic acid salt and other injections into the volume procurement, which seemed to give the traditional Chinese medicine injection industry a new opportunityShen Yong said that this time, these products are included in the procurement with volume in Qinghai Province, which shows that these products have good clinical effect, also shows the recognition and support of the state for traditional Chinese medicine injection, in addition, it also shows that it has a certain strategic reserve significanceLi Changcheng and Shen Yong share the same view, stressing that it may also be full of the government's expectations for the development of traditional Chinese medicine< br / > for traditional Chinese medicine injection, it can obtain the guarantee of sales volume when it is included in the volume purchase, but at the same time, it is faced with substantial price reductionHow to treat "purchasing with quantity" dialectically? Both experts said that the advantages outweigh the disadvantages< br / > SHEN Yong said that there is still profit after the price reductionIt can quickly seize the leading position in the market, occupy the market with a multi product portfolio, and increase the recognition of doctors and patients for its curative effect, so as to seek long-term development in the futureLi also stressed that centralized mining and price reduction are inevitable trendsAt least, the volume procurement solves the market problems, and the government will also consider the production cost and quality problems of enterprises< br / > the two experts also made suggestions to the relevant enterprises, constantly improving the product quality, actively participating in the government level volume procurement, making every effort to enter more provinces volume procurement, once entering 10-15 provinces, it can achieve market accommodation, otherwise it will lose the marketVolume purchase should be regarded as the last life-saving straw for traditional Chinese medicine injections, because it is not like oral preparations that can be turned to OTC marketOnce the centralized market is lost, there is only one way to stop production< br / > as a unique dosage form in China, the safety of traditional Chinese medicine injection has been controversialAccording to the national ADR monitoring annual report (2019) issued by the national ADR testing center, in 2019, the ADR / event reports of traditional Chinese medicine were distributed according to the route of administration, with injection taking up 45.5%, and intravenous injection taking up 98.5% of the total< br / > for the safety risks brought by traditional Chinese medicine injection, Shen Yong thought that it should be treated rationally: "it is the third poison of medicine, and any medicine has risksNow, the clinical use of traditional Chinese medicine injection has been standardized through the national restrictions (use in hospitals above the second level)" Li Changcheng said that adverse reactions have always been a barrier that traditional Chinese medicine injections are difficult to crossThe reasons for this phenomenon are: Traditional Chinese medicine injection is refined and produced on the basis of traditional Chinese medicine, lack of scientific basis; the control of production process and equipment on product quality is inconsistent; the control of raw materials on later product production; the irregularity in the transportation and storage process; of course, the irregularity in the use process, etc< br / > how to reduce the incidence of adverse reactions of traditional Chinese medicine injection? Li Changcheng said, first of all, we should strictly control the raw materials; second, we should adopt advanced equipment, optimize production technology, strictly control production quality, reduce impurities in the finished products, and ensure their purity; of course, we should also pay attention to regulating the transportation process and storage requirements of drugs; at the same time, we should regulate the use methods of drug doctorsShenyong also added that enterprises should strengthen post market scientific research on products, constantly find potential problems of products (such as allergy, sensitization, adverse reaction rules), and formulate clinical response plans as early as possible < br / > in addition to adverse reactions, clinical abuse is also criticized For example, the dosage and method are not standardized, the dispensing is not scientific, and the use is beyond the scope This is also the cause of many clinical adverse reactions or medical accidents, causing unnecessary losses to people's lives and property, and increasing the payment burden of medical insurance fund and patients Therefore, after 2017, the state has implemented a "double restriction" policy on the use of traditional Chinese medicine injections (limited to hospitals above the second level and limited clinical use); many places have included traditional Chinese medicine injections in the key monitoring list < br / > for these measures of relevant government departments, Li Changcheng commented that this shows that the problems in the use of traditional Chinese medicine injections are not an example and have a greater impact The above-mentioned monitoring means are just the awe of the state to life, the life of the people is higher than everything; they are also the warning to the production enterprises and medical institutions Shenyong added that it also has a certain relationship with the large occupation of national medical insurance costs by traditional Chinese medicine injection < br / > in addition to the above problems, in recent years, some traditional Chinese medicine injection enterprises have high marketing costs and low R & D costs, which are also controversial places Some even think that traditional Chinese medicine injection enterprises have huge profits For such "different voices", Shen Yong said that the production process of traditional Chinese medicine injection is complex, the purity and accuracy of the product are higher than the requirements of oral capsules, granules, tablets, etc., resulting in high production costs, so I don't think there is a theory of huge profits In fact, the disaster area with huge profits in the medical field is the medical equipment (CT, MRI, biochemical instrument) with millions and tens of millions of yuan Li Changcheng said that there is no such thing as windfall, but it is worth pondering where windfall has gone In my opinion, more "marketing expenses" have been spent, so the phenomenon of "high marketing expenses and low R & D expenses" appears, which should be caused by the marketization of clinical drugs, or the purchase and use of clinical drugs have problems "I think that focusing on purchasing with volume can solve these problems and enable enterprises to focus more on scientific research and quality." Shen Yong also stressed that the phenomenon of "high sales cost and low R & D cost" has always existed, which is a problem for traditional Chinese medicine enterprises He hoped that the majority of enterprises could change this phenomenon as soon as possible, learn from enterprises such as Yiling pharmaceutical and HongRi pharmaceutical, increase investment in scientific research, and make products fly more stably and in a long term with the wings of scientific research < br / > during this year's national "two sessions", Zhao Chao, President of step pharmaceutical, pointed out that the lack of corresponding standards and procedures for traditional Chinese medicine injections has resulted in the phenomenon of uneven quality and mixed interests So, how to standardize the development of traditional Chinese medicine injection industry? < br / > SHEN Yong put forward four personal suggestions: 1 Strictly control the import, the state should strictly approve the batch number of traditional Chinese medicine injection products, increase the review of each clinical research link, and increase the punishment, for example, once there is data fraud, no new drug approval can be applied for three years; 2 Strictly control the production, regular flight inspection, irregular spot check; 3 Strictly control the use, increase the monitoring of adverse reactions; 4 Give rewards, For example, let the products of law-abiding and well behaved enterprises enter the medical insurance, basic medicine, changeable dosage forms, etc., and finally realize the elimination of bad money by good money < br / > Li Changcheng believes that the first thing to do is to start from the source Qualified raw materials, strict production technology, advanced equipment, and the same standard of testing are the basic elements to promote the healthy development of traditional Chinese medicine injection industry novel coronavirus pneumonia industry has begun to embark on the road of standardized development in recent years, and played a very important role in the fight against the new crown pneumonia It can be seen that in addition to the controversy, the clinical value of traditional Chinese medicine injection is still worthy of affirmation and further development Li Changcheng said that traditional Chinese medicine can be passed on for thousands of years, and its clinical value is undoubted, especially in chronic diseases or some sudden public health events Shen Yong also said that from the practice of nearly 20 years, traditional Chinese medicine injection can indeed play a significant role in anti-inflammatory, heart strengthening, brain rejuvenation, first aid and other aspects In some areas, it can even be described as "coming back from the dead and having an immediate effect" The next step is how to carry forward these clinical values Shen Yong believes that it is necessary to achieve government recognition, policy support, implementation and publicity Li Changcheng also suggested that we must do a good job in scientific analysis and clarify the scientific basis; promote and popularize the culture of traditional Chinese medicine so that more people can understand and understand the culture of traditional Chinese medicine; strengthen clinical research and discuss clinical manifestations; formulate production and use standards to standardize production and use behavior < br / > in order to further develop the clinical value of traditional Chinese medicine injections, in recent years, many insiders are calling for "implementing and promoting the reevaluation of traditional Chinese medicine injections as soon as possible" During the national "two sessions" this year, there are representatives of the pharmaceutical industry who strongly appeal The author combed and found that the "re evaluation of traditional Chinese medicine injection" work can be seen in the notice on re evaluation of safety of traditional Chinese medicine injection (gsyjb [2009] No 28) issued by the former State Food and Drug Administration in 2009, but it has been difficult to implement for so many years In response, Shen Yong said that the root cause is still the problem of "who will pay for the reassessment" It's a little difficult for enterprises to pay for their own money Li Changcheng thinks it is also related to quality standard, production process, test standard, clinical performance, adverse reactions and other factors if we want to push ahead with these tasks as soon as possible, Shen Yong thinks that we need to solve the following problems urgently: 1., who will be out of the cost; 2., the question of the evaluation standard (many Chinese medicine injections are original research varieties, no reference materials); 3., the fairness of the evaluation (experts has the final say?) Chinese medicine experts has the final say? Western medicine experts has the final say? Patient has the final say? What has the final say? CDR has the final say..... ; 4 Reward and punishment In addition, it's better to issue a "draft for comments" to listen to everyone's opinions and try to reach a basic consensus before proceeding < br / > under the influence of policies such as volume purchase and re evaluation, and the positive influence of "effective anti epidemic", where will the next step of traditional Chinese medicine injection go? Can Nirvana be realized? Shen Yong said that the whole traditional Chinese medicine injection industry