Three enterprises were fined tens of millions of yuan for cracking down on the monopoly of APIs by the state

[China Pharmaceutical network industry trends] in the face of the "high fever does not go back" of the rising prices of APIs, the country finally stepped up It is understood that the website of the State Administration of market supervision and Administration recently announced that it has issued tens of millions of Yuan fines to three manufacturers of glacial acetic acid API According to the news, Chengdu Huayi pharmaceutical accessories manufacturing Co., Ltd., Sichuan Jinshan Pharmaceutical Co., Ltd and Guangdong Taishan Xinning Pharmaceutical Co., Ltd were punished by 12.8338 million yuan according to law for monopolizing According to the State Administration of market supervision, the three companies have seriously disrupted the order of market competition, increased the burden on downstream pharmaceutical enterprises and harmed the normal treatment of dialysis patients However, the above-mentioned monopoly of glacial acetic acid APIs is only a microcosm of the current monopoly of APIs Therefore, it is urgent to strengthen the regulation of monopoly of APIs According to the industry, API is the area where monopoly cases are more concentrated in recent years "The market value of some kinds of APIs is not large, and the annual output value is not much, but the corresponding output value of downstream drugs can reach 100 billion yuan The control of API is a "bottleneck" for drug production The monopoly behavior in API field damages the legitimate rights and interests of patients and pharmaceutical manufacturers, and destroys the market order of fair competition In recent years, the prices of some kinds of APIs have been rising tens or even hundreds of times, which makes the pharmaceutical enterprises complain incessantly and even affects the patients' medication "Downstream pharmaceutical enterprises directly feel the pressure of API monopoly, their normal production behavior is affected, and they are forced to reduce production or even stop production, and their product sales in domestic and foreign markets are also affected At the same time, the development of API industry itself is also affected by monopoly " Some industry people said that in recent years, in the relevant reports, the words "facing the difficulties of production suspension" and "forced production suspension and conversion" appeared repeatedly The monopoly of APIs is stronger than that of tigers The purpose of curbing monopoly is to standardize the market order, promote the orderly development of the industry, stabilize the drug price and pay attention to the people's livelihood, so as not to let the rise in the price of APIs drag the people's drug use Recently, the State Administration of market supervision imposed a legal penalty of 12.83 million yuan on three manufacturers of glacial acetic acid APIs This is also a large penalty for anti monopoly cases in the field of APIs since the implementation of the anti monopoly law of China In recent years, China attaches great importance to solve the problem of monopoly of APIs Now in September, the opinions on improving the national essential drug system put forward that anti-monopoly investigation should be carried out and punishment should be strengthened for the suspected monopoly behaviors Many places have also introduced relevant measures to ensure the supply of APIs The rise in the price of API monopoly will lead to the rise in the price of relevant commonly used drugs Some industry insiders say that it will be a long-term trend for regulators to crack down on monopoly In view of the current situation of monopoly cases in the field of APIs, it is undoubtedly necessary to maintain the normal market order Other experts pointed out that in addition to cracking down on monopoly, the reform of the examination and approval system is also expected From the published cases of API monopoly in recent years, most of the approved manufacturers of the monopolized API are single digits, and only two or three are actually put into production Such a highly centralized API market structure not only increases the risk of supply interruption, but also facilitates the price monopoly of API manufacturers and their associated distributors It is understood that with the promotion of the reform of the approval system, API will no longer be issued with an approval number alone in the future As long as the quality meets the standards, pharmaceutical enterprises can apply for related approval, so the monopoly situation of API may be improved For example, the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical medical devices issued in October 2017 clearly put forward that the approval of drugs, pharmaceutical raw and auxiliary materials and packaging materials will be carried out "To curb monopoly, it is necessary to crack down on monopoly behavior and increase market supply." Some experts said At present, the health China strategy is advancing, and our country is deeply concerned about the problem of mass drug use China expects that the price mechanism of API will be more reasonable and the monopoly of API market will be further solved.