In 2018, 49 drugs were modified in the instruction manual, 23 injections were eye-catching, and a large number of children were forbidden to use drugs

The basic function of drug instructions is to guide the safe and rational use of drugs In recent years, in order to strengthen drug supervision, further protect the public drug safety and standardize the use of drugs, one by one drug instructions have been revised In terms of the varieties of the instructions modified in 2018, the injection products are more involved, and almost all of them are best-selling varieties and star drugs; in terms of the specific content of the modification, the keywords prohibited and carefully used by children are more frequent 49 product specifications were modified, and 23 were injection varieties According to the statistics of the small edition, up to now, the State Drug Administration has proposed to modify 27 document numbers of the instruction manual Except for the recently modified drugs including codeine and cold drugs, the remaining document numbers of the instruction manual involve 49 drug types, including 14 traditional Chinese medicine, 12 chemical drugs and 1 biological drug, which are recombinant human interleukin-11 injections See the following table for details: (Note: according to the announcement of the State Drug Administration, 23 of the 49 drugs modified the instructions are injection varieties, accounting for nearly half of the total modified instructions, including 13 traditional Chinese medicine injections, 9 chemical injections and 1 biological product 13 Chinese medicine injection instructions have been revised, and 10 billion market turbulence 13 Chinese medicine injection instructions have been revised, including Chaihu Injection, Shuanghuanglian injection, Qingkailing injection, Xuesaitong injection and a series of large varieties of Chinese medicine injection See the table below for details: Among them, it is worth mentioning that Xuesaitong injection and Xueshuantong injection with an annual sales volume of more than 10 billion include four varieties, namely Xueshuantong injection, Xueshuantong for injection (freeze-dried), Xuesaitong injection and Xuesaitong for injection (freeze-dried) According to the data released on the Internet, Xueshuantong (freeze dried) for injection ranked first among the top three best-selling brand drugs in 2016, with a sales volume of 8 billion yuan According to the pharmaceutical intelligence data, at present, there is only one domestic approval document for Xueshuantong (freeze-drying) for injection, and only Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd is the manufacturer The modification of this specification will inevitably affect the cost of the enterprise and reduce its sales In terms of the whole market of traditional Chinese medicine injection, due to the frequent occurrence of problematic varieties, the state's supervision of traditional Chinese medicine injection is increasingly strict, and a large number of large varieties are affected by the revision of the instructions, which is even worse According to this year's mid annual report, the performance of several traditional Chinese medicine injection enterprises has declined significantly: for example, Zhongheng group, a representative group, achieved a net profit of 271 million yuan from January to June 2018, nearly 40% lower than the net profit of 37200 yuan in the same period last year; mainly relying on the business income brought by traditional Chinese medicine injection Xingnaojing injection and Shenmai injection In the first half of 2018, the net profit of Dali pharmaceutical fell by 97.16%; moreover, this year, the instructions of Xueshuantong injection and Shenmai injection were revised, the scope of prohibition was further expanded, and the market sales would face more serious shrinkage The modification of nine chemical injection instructions has affected nine chemical injection instructions of more than 100 pharmaceutical companies, including lysine for injection, amiodarone for injection, glutathione injection, etc the details are as follows: according to the estimation of insiders, the overall market of glutathione in China is about 5 billion yuan According to the data of HDM system, the amount of glutathione used in public hospitals in 16 key cities in China reached 530 million yuan in 2015 According to pharmaceutical intelligence data, there are 30 approvals for glutathione injection Market in China, including Chongqing Yaoyou pharmaceutical, Shanghai Fudan Fuhua pharmaceutical, Shandong LVYE pharmaceutical, Fu'an Pharmaceutical Group, Hubei people's pharmaceutical and Guangzhou Baiyunshan Mingxing pharmaceutical In addition to such a large variety of glutathione injection, there are also a number of varieties with good sales volume and many manufacturers involved For example, there are 54 market approvals for gastrodin injection, involving 37 manufacturers; 3 domestic approvals for amiodarone hydrochloride injection, involving 3 manufacturers; 62 calcium gluconate injection, involving 52 manufacturers; 58 market approvals for lysine for injection, involving 24 manufacturers Drugs commonly used by children are prohibited According to the specific modification contents of 23 modified instructions for traditional Chinese medicine preparation, 10 of them are related to children's prohibition and careful use of relevant contents, and there are many recommended medicines for children's cold and fever relief - Chaihu Injection, which have been used for 70 years It is necessary to note that the prohibition of children aged 4 and below will inevitably affect their market sales It is reported that Bupleurum injection is the world's first liquid injection of traditional Chinese medicine Previously, it has been widely used as a "antipyretic needle" for children's fever treatment In 2016, the sales volume of Bupleurum injection in public medical institutions in China was 38.91 million yuan According to the pharmaceutical intelligence data, there are 78 market approvals for Chaihu Injection in China, involving 75 manufacturers, including Yunnan Baiyao, Taiji group, State Pharmaceutical Group Yibin pharmaceutical and other major enterprises In addition to Bupleurum injection, Shuanghuanglian injection, Danshen injection and other commonly used injections for children are also restricted There are a large number of other commonly used drugs for children According to statistics, from 2018 to now, nearly 20 of the varieties that modify the instruction manual involve the modification of children's medication items (it needs to be noted here that the cold medicine containing codeine is a large variety here According to the intelligence data of medicine, there are currently 28 market approvals for codeine drugs, 13 products are involved except for the raw materials, which are compound codeine phosphate solution and compound codeine phosphate solution Oral solution, codeine phosphate tablets, aspirin codeine tablets, paracetamol dihydrocodeine tablets, dihydrocodeine tartrate tablets, dihydrocodeine tartrate tablets, codeine phosphate syrup, codeine phosphate injection, codeine Platycodon grandiflorum tablets, compound codeine phosphate tablets, compound codeine phosphate oral solution, compound codeine phosphate syrup, codeine phosphate sustained-release tablets), the following table is small The revised form of children's prohibition and careful use of drugs compiled in 2018, let's take a look