Some "life-saving drugs" are in urgent need, which forces the transformation and upgrading of API industry

[market analysis of chinapharma.com] it is reported that in recent years, in many hospitals in Zhejiang, Shanghai, Liaoning and other places, there has been a shortage or unstable supply of life-saving drugs, and the price has increased accordingly For example, in a hospital in Liaoning, the cost of fluorouracil for injection for breast cancer treatment has increased from a few cents to tens of dollars Behind the shortage of "life-saving drugs" and the rising price is the shortage of APIs, which also affects the clinical medical quality, life safety and drug burden of patients In fact, not only in the near future, the soaring price of APIs in 2018 has been very serious In 2018, the market price of chlorpheniramine increased 58 times in one month, from 400 yuan / kg to 23300 yuan / kg; phenol, an important raw material of aspirin and other drugs, increased 100 times from 230 yuan / kg to 23000 yuan / kg The analysis of the causes of drug shortage is mainly affected by the following aspects First, there are few manufacturers of API It is revealed that there are about 1500 kinds of APIs in China, of which only one enterprise has obtained the approval qualification to produce 50 kinds of APIs, only two enterprises can produce 44 kinds of APIs, and only three enterprises can produce 40 kinds of APIs In addition, 10% of APIs can only be produced by single digit manufacturers, and the production of APIs is controlled by a few manufacturers It can be seen that when a API enterprise stops production, the corresponding drugs are prone to shortage Second, environmental protection pressure continues As the domestic environmental protection policy becomes stricter, many small and medium-sized API enterprises stop production or close down due to unqualified environmental protection indicators According to the data, by the end of November 2015, there were 5065 API and preparation manufacturing enterprises in China; by 2017, the number of enterprises had dropped to 4376, and it has been declining in the past two years Some analysts believe that "there are only two or three API manufacturers left, and it is easy to cause the shortage of API once encountering factors such as production line transformation and cost rise." Third, the middlemen monopolize maliciously In addition to the objective factors such as environmental protection and the small number of enterprises obtaining approval, middlemen exploit the market vacancy and abuse the market monopoly position, which is also very easy to lead to the shortage of APIs and thus increase the price In order to fight against the monopoly of APIs, the General Administration of market supervision strengthened its supervision For example, the two major drug monopoly cases of glacial acetic acid and chlorpheniramine, which once caused a sensation in the industry, both fined more than 10 million yuan, alerted the drug monopoly enterprises, which was conducive to maintaining fair competition in the drug market and creating a more stable development situation in the industry However, some people in the industry have suggested that in the future, the law should be revised to investigate the criminal responsibility of relevant responsible persons "At present, the anti-monopoly law only punishes enterprises as legal persons, but does not punish their relevant responsible persons, which does not play a deterrent role." In addition, to fundamentally solve the problem of API monopoly, we need to change the API audit system "We will promote the reform of the approval system for APIs as soon as possible If large pharmaceutical enterprises can produce APIs themselves, and the number of API enterprises becomes larger, there will be no monopoly." With the opening of the new year, the development of API industry has attracted more attention The author believes that environmental protection affects the sustainable development of enterprises China should continue to strengthen environmental protection and safety supervision, force the transformation and upgrading of API industry, improve the intensive production level of API, and promote enterprises to take the road of "near zero emission" and green production in the process of adjusting product structure, improving production process and technology.