Price is coming! 41 varieties are forced to reduce price due to lack of conformity evaluation

Suspension of purchase, forced price reduction, cancellation of approval It is obvious that the generic drug market which has not passed the consistency evaluation has entered the white hot stage A number of varieties which have not passed the evaluation will face the market rout or even be out in the near future 41 varieties and hundreds of product specifications, including 141 Chinese and foreign pharmaceutical enterprises such as Harbin Pharmaceutical Co., Ltd., Baiyunshan Pharmaceutical Co., Ltd., Zhongmei Shike Pharmaceutical Co., Ltd and Shandeshi Pharmaceutical Co., Ltd., will face a big price dive because they fail to pass the consistency evaluation! On July 12, 2019, Jiangxi Medical Procurement Service Center issued a notice on publicizing and adjusting the purchase price of drugs that failed to pass the conformity evaluation of quality and efficacy of generic drugs, which made the trend clear According to the notice, with the consent of Jiangxi Medical Security Bureau, it is planned to adjust the purchase price of a batch of drugs that fail to pass the quality and efficacy consistency evaluation of generic drugs to the lowest price of the approved varieties It is worth noting that the notice issued in Jiangxi involves a large number of enterprises and a wide range of product specifications, which rarely appears in a long period of time since the progress of the conformity evaluation of quality and efficacy of generic drugs What's more, this notice has made clear the specific range of price reduction and "ceiling" price of non evaluated varieties, which is enough for the industry to have a fairly intuitive understanding of the previous market status of these varieties According to the annex, more than 100 varieties of 41 generic names are listed in the price reduction list, with a maximum drop of 87% In terms of the specific absolute value of price reduction, the most price reduction is the tegio capsule of Shandong new era Pharmaceutical Co., Ltd., whose main competitors Qilu Pharmaceutical Co., Ltd and Hengrui Pharmaceutical Co., Ltd successively passed the consistency evaluation in March 2019 At this time, Shandong new era can only choose the passive price: the original purchase price is 1543.97 yuan, which Jiangxi requires to be reduced to 568.7 yuan, with a price reduction rate of 63% On the whole, 141 manufacturers are involved in the price reduction, including Yangzi River, Sino US Tianjin Shike, Shiyao group, Huabei pharmaceutical, Guangyao Baiyunshan, Sanders, Lizhu, Kelun, Kangmei, Lepu, xinlitai, etc 01 limit upgrade, price is up! In fact, this is not the first time for Jiangxi Province to "start" against varieties that fail to pass the consistency evaluation of quality and efficacy of generic drugs According to industry media reports, as early as August 2018, Jiangxi pharmaceutical purchasing service platform issued two notices successively Since there are three enterprises that have passed the consistency evaluation, it made a decision to "suspend online shopping and not allow online shopping" for six products of six enterprises On November 5, 2018, Jiangxi issued a notice again, which was also due to the suspension of procurement for three product specifications of two pharmaceutical companies through the conformity evaluation of three varieties Jiangxi is not the only province to adopt policies on generic drugs that have not been evaluated According to incomplete statistics of e-drug managers, up to now, Zhejiang, Hunan, Guangxi, Fujian, Tianjin, Hebei, Jilin, Liaoning, Shaanxi, Gansu and other provinces have successively issued documents, which have clear provisions on the tentative procurement of varieties that fail to pass the consistency evaluation of quality and efficacy of generic drugs 4 + 7 pilot areas, such as Shanghai and Beijing, have also made it clear that the purchase price of non evaluated varieties must be lower than the centralized purchase price According to the documents circulated in the second round of 4 + 7 symposiums, in the future, three generic drugs that have passed the consistency evaluation will not be allowed to purchase the drugs that have not been evaluated, not only will they not be purchased, but also will not be reimbursed It can be said that the life and death time of generic drugs has really come It is worth noting that if the previous "no trading" is aimed at the three varieties that have been evaluated, then Jiangxi is aiming at a wider range of products: that is, as long as the variety has been evaluated by the manufacturer, other enterprises must take it as the ceiling price, and those higher than this price will be asked to reduce their prices Take ambroxol hydrochloride tablets as an example This is an "old medicine" originally developed by bringer Ingelheim and approved to be listed in Germany as early as 1979 According to the data, from 2013 to 2017, the terminal sales of this product in China's public medical institutions reached up to 260 million yuan, of which the original manufacturer accounted for nearly half of the market share The remaining varieties are divided by 8 local enterprises including Hengrui Up to now, only Hengrui and Luoxin have passed the consistency evaluation Under the requirements of this notice from Jiangxi Province, six enterprises, including Shanghai Hengshan Pharmaceutical Co., Ltd., Tianjin Huairen Pharmaceutical Co., Ltd., sanders (China), Heilongjiang ollidanide Pharmaceutical Co., Ltd., Beijing Pacific Pharmaceutical Co., Ltd and Shantou Jinshi Pharmaceutical Co., Ltd of Sinopharm group, which have not been evaluated, need to be adjusted to a unified price Take the 30mg * 20 tablets with the largest quantity as an example, the unified unit price stipulated by Jiangxi is 1.983 yuan, while the current price of several imitations varies from 4 yuan to 14.8 yuan According to this situation, the highest price reduction will be the 30mg * 20 tablet standard of Shanghai Hengshan pharmaceutical, with a price reduction of 87% Another example is tegio capsule, which has attracted much attention for some time Tegio capsule is an anti-tumor drug originally developed by Dapeng Pharmaceutical Co., Ltd of Japan It was first listed in Japan in 1999 and imported into China in 2009 At present, it has only three domestic listed companies, namely Qilu pharmaceutical, Hengrui pharmaceutical and one of the subsidiaries of Lunan pharmaceutical, Shandong new era According to the public data, the domestic sales of this variety in 2017 was 2.8 billion yuan But in March 2019, the tegio capsules of Qilu pharmaceutical and Hengrui pharmaceutical passed the consistency evaluation one after another almost at the same time, so that the competition pattern between them is clear at a glance In the case that price reduction is needed to deal with bidding procurement in various regions, Qilu pharmaceutical and Hengrui pharmaceutical still have "increased holding" of evaluated varieties with consistent evaluation, and they can enjoy some products with policies to be determined, while products without evaluation seem to have only one way to go Not long ago, Shandong new era tegio capsule was just suspended from online trading in Zhejiang due to "not agreeing to reduce the price" Now Jiangxi demands 63% of its price reduction, which is obviously not good news for Shandong new era 02 enterprise: go all out to catch the first generic drugs that have not been evaluated In fact, Jiangxi Province has already released top-level documents In November 2018, the people's Government of Jiangxi Province issued the implementation opinions on the reform and improvement of the supply guarantee and use policy of generic drugs, which stipulates that the purchase price of non evaluated drugs shall not be higher than the purchase price of the approved drugs; if there are three enterprises with the same type of non evaluated drugs, they will no longer purchase the non evaluated drugs, and they have been online purchased on the provincial pharmaceutical purchase service platform, they shall temporarily Stop online purchasing qualification This is basically consistent with the national requirements for the conformity evaluation of generic drugs However, from the content of the document released this time, it is the first time that Jiangxi explicitly requires 41 generic varieties of 141 manufacturers to reduce their prices and stipulate the price reduction range According to e drug manager's query of the public information, this may also be the first requirement for the price adjustment of non evaluated products with reference to the price of evaluated products (the scope of statistics is limited, welcome to clap bricks ~) in addition, according to such regulations, the first price that passes the consistency evaluation will become the price ceiling of products that have not been evaluated This also means that enterprises should try their best to seize the "first imitation" of consistency evaluation varieties from the previous "top three", because only when they get the "first imitation" can they have price autonomy A broader "price killing" of generic drugs in China has come According to the price reduction catalogue issued by Jiangxi Province, there are only one or two enterprises that have been evaluated for many products, while for the rest products that have not been evaluated, on the one hand, there is no support of "consistency evaluation" On the other hand, the current restricted purchase price is a direct loss of profits for the enterprise On the other hand, even if there is such fierce competition for generic drugs, there is still 87% room for price reduction like Shanghai Hengshan pharmaceutical, which shows that generic drugs are generally criticized as "high price" in a wide range In the tide of national "drug price reduction", how many generic drugs survive by high price strategy and marketing means, once the price is limited, the road behind them will be everywhere constrained, and the only thing in front of them is the fate of being shuffled When the general office of the State Council issued the opinions on the evaluation of quality and efficacy consistency of generic drugs, it was clearly emphasized that if more than three manufacturers of the same kind of drugs have passed the consistency evaluation, the generic drugs that have failed the consistency evaluation will not be used But in fact, the progress of conformity assessment is hardly optimistic According to official data of the State Drug Administration, as of the end of November 2018, 112 varieties have been evaluated, 90 of which belong to "289 varieties", only about 31% of which have been completed According to the statistics of pharmaceutical cloud studio, up to now, 309 product specifications have passed the consistency evaluation, including 24 varieties with more than three reviews It is worth noting that with the implementation of the consistency evaluation work, various regions have implemented it in succession, and large varieties have been suspended from the Internet or trading qualification On October 18, 2018, Heilongjiang released the first batch of varieties whose online trading qualification was suspended due to failure of conformity evaluation, involving 23 enterprises On November 22, 2018, Jiangsu Province issued a notice to suspend the purchase of 9 drugs that failed the conformity assessment, involving 9 enterprises Including amlodipine besylate tablets in Baiyunshan, Guangzhou, and rosuvastatin calcium tablets in lunanbete On May 9, 2019, the second batch of list was released, including amoxicillin capsule, rosuvastatin calcium and other varieties, involving 122 enterprises On May 9, 2019, eight varieties of 94 pharmaceutical companies including Hengrui were suspended from online trading in Guangxi, including large varieties such as atorvastatin calcium and cefuroxime ester tablets This is the third batch of lists released by Guangxi that have been disqualified for online transactions due to failing to pass the consistency evaluation On July 15, 2019, Jiangsu Province issued the notice on suspending the purchase of drugs that failed to pass the quality and efficacy consistency evaluation of generic drugs 133 drugs that failed to pass the evaluation were suspended, involving 123 pharmaceutical companies In fact, the current situation is very clear No matter from the treatment plan of non evaluated varieties or the trend of centralized procurement revealed in the second round of 4 + 7, the consistency evaluation of quality and efficacy of generic drugs is a must Today's situation is even no longer the state that "no consistency evaluation is waiting for death, and consistency evaluation is looking for death" circulated in the industry before To a large extent, for the vast majority of imitated varieties, passing the consistency evaluation will be the legal basis for all subsequent market behaviors, such as suspension of procurement, forced price reduction, cancellation of approvals The market cleaning of generic drugs that fail to pass the consistency evaluation has obviously entered the white hot stage A batch of varieties that fail to pass the evaluation will face the market rout or even exit in the near future, so the enterprise must take precautions Original title: 41 varieties were forced to reduce price because of no conformity evaluation! Involving 141 pharmaceutical companies such as Harbin Pharmaceutical and Baiyunshan Pharmaceutical, the price is coming!