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    Home > Active Ingredient News > Drugs Articles > An inventory of major events in China's API industry in 2017

    An inventory of major events in China's API industry in 2017

    • Last Update: 2018-01-04
    • Source: Internet
    • Author: User
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    Stop production! Cut production! Antitrust! Relocation tide! In 2017, the API industry, which used to be the pride of China's pharmaceutical industry, seems to have become a street mouse After the cold winter, can the API usher in the spring? Starting from the main contradiction between environmental protection and price, the author reviews the major events in China's API industry in 2017, and discusses with you where the API industry will go in the future behind the next major event Winter is coming! The globally familiar line in the game of thrones, which is used to describe China's API industry today, may not be more appropriate As the world's largest exporter of APIs and the second largest producer of APIs, the API industry used to be the pride of China's pharmaceutical industry, but now it seems to have become a rat in the street Stop production! Cut production! Antitrust! Relocation tide! These hot words frequently appeared in 2017 undoubtedly indicate that the API industry is in a cold winter's dilemma The author thinks that the main contradiction in API industry lies in the contradiction between environmental protection and price, and whether the DMF system just released at the end of the year can completely solve this contradiction is not known Here, the author starts from the main contradiction between environmental protection and price to review the major events in China's API industry in 2017, and discuss with you where the API industry will go in the future behind the next major event Environmental protection vs price the contradiction between environmental protection and price has always been the main contradiction of API industry For a long time, it seems to be a problem of fish and paw If we want to protect the environment, there is no doubt that the production reduction and shutdown of API manufacturers will cause the increase of API price; if we want to increase the price, then the start-up of a large number of API manufacturers will undoubtedly cause environmental pollution Environmental protection - in January in history, Zhejiang Province issued and implemented the emission standard of air pollutants for chemical synthetic drugs, which is the local standard for air pollutants emission set for chemical synthetic drugs in China   In March, the Ministry of environmental protection, the national development and Reform Commission, the Ministry of finance, the State Energy Administration and the people's governments of Beijing, Tianjin, Hebei, Shanxi, Shandong and Henan issued the work plan for air pollution prevention and control in Beijing, Tianjin, Hebei and surrounding areas in 2017, which requires that all pharmaceutical and pesticide enterprises in '2 + 26' cities stop production in winter heating season, and the implementation scope includes Tianjin and Beibei Beijing, Shijiazhuang, Jinan, Zhengzhou, Taiyuan and other cities In November, the Ministry of industry and information technology, the Ministry of environmental protection and other departments jointly issued a notice that in the heating season (November 15, 2017 to March 15, 2018), 28 urban raw material pharmaceutical enterprises alternately stopped production, involving all the VOCs emission processes At the same time, the health and family planning departments at all levels are required to comprehensively consider the monitoring results of the shortage of drugs, the varieties of national essential drugs, emergency (rescue) drugs, and other clinically necessary and easily short drugs, and propose suggestions on the supply and guarantee of the bulk drug varieties that should be staggered production in principle according to the provisions In December, Huabei Pharmaceutical Co., Ltd., a pharmaceutical enterprise, was listed as a penalty for violating the law on the prevention and control of air pollution In December, 10 ministries and commissions including the Ministry of environmental protection and the national development and Reform Commission, together with 6 provincial (municipal) governments including Beijing and Hebei, issued the action plan for comprehensive treatment of air pollution in autumn and winter 2017-2018 in Beijing, Tianjin, Hebei and surrounding areas, which emphasized that pharmaceutical enterprises involved in API production will be shut down in principle if they violate the anti emission process In December, the State Council issued the notice on the issue of the attribution of income from environmental protection tax, making it clear that the environmental protection tax law will be officially implemented from January 1, 2018 Industry insiders said that domestic pharmaceutical enterprises with a certain scale at present, if calculated according to the environmental protection tax law, only the cost of sewage treatment will be more than 100 million yuan, and does not include waste gas, solid waste, etc This year can be said to be a year of strict environmental protection supervision in API industry Part of the raw material pharmaceutical enterprises have reduced production by 80%, dozens of pharmaceutical enterprises are facing shutdown, 100 pharmaceutical enterprises need to be relocated, and more seriously, the cost of pollution control will increase by an order of magnitude Some insiders pointed out that with the implementation of the environmental protection tax law, domestic pharmaceutical enterprises with a certain scale at present, if calculated according to the environmental protection tax law, only the cost of sewage treatment will be more than 100 million yuan, and does not include waste gas, solid waste, etc Price - antitrust in November, the national development and Reform Commission officially released the guide to price behavior of short drugs and API operators, facing several problems in the production and circulation of short drugs and API There are 13 articles in the guide, articles and 2 clarify the relevant concepts in the field of drugs in short supply and APIs, and list the relevant market definition and consideration factors of market dominance Articles 3 to 12 specify the forms of manifestation, illegality identification and exemption conditions of price monopoly agreements of various kinds of price monopoly behaviors in the field of short drugs and APIs Article 13 remind the relevant business operators not to fabricate and spread the price increase information, collude with and manipulate the market price and other acts in violation of the price law on drugs in short supply and APIs The national development and Reform Commission also said it will continue to investigate and assess the overall competition in the drug shortage and API market, strengthen law enforcement, respond to social concerns, and update and supplement the guide in accordance with law enforcement practices Different from the opinion draft issued in August, the official draft specifies the behaviors of the operators of short drugs and APIs in violation of the anti monopoly law, as well as the behaviors in violation of the price law Due to the upgrading of environmental protection supervision, many API companies were limited or stopped production because they failed to meet the standards As the upstream industry of pharmaceutical industry, API prices rose and API supply was cut off For example, in November, the relevant person in charge of the national health and Family Planning Commission explained the reasons for the "shortage of cheap domestic drugs for children with leukemia", such as the small clinical dosage, the rising price of APIs, the rising cost, the difficulty in purchasing, the reduction in the number of manufacturers and other reasons However, the author believes that the implementation of the guide can only temporarily curb the rise of API prices, and can not fundamentally solve the problem Is the DMF system the fundamental solution? In November, CFDA issued the announcement on adjusting the review and approval items of APIs, pharmaceutical excipients and drug packaging materials, canceling the approval of packaging materials and containers of pharmaceutical excipients and drugs in direct contact APIs, pharmaceutical excipients and drug packaging materials shall be reviewed and approved at the time of approval of drug preparation registration application The era of API approval number officially ended, and the DMF filing system really came To implement DMF system and relax the entry threshold of API manufacturers can solve the problem of API price monopoly to a large extent, but it is unrealistic to rely on a DMF system to drag API industry out of the mire The API industry needs the joint efforts of regulators and API companies For the regulators, the author believes that environmental protection is important, but it should be done step by step The "great leap forward" type of one size fits all is not desirable, and the regulators should give raw material pharmaceutical enterprises a buffer time for transition For raw material pharmaceutical enterprises, instead of taking passive measures such as relocation and production reduction to avoid short-term pressure, it is not as good as the European and American pharmaceutical companies to continuously improve production The active action of process technology is to reduce emissions and improve the gold content of products Although winter is coming, will spring be far behind when winter comes? The author believes that the API industry will have a new luster when the history is over Original title: 2017 China API industry event Author: Vegetable
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