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    Home > Active Ingredient News > Drugs Articles > Due to the monopoly of APIs, the production and supply of these drugs will be stopped in 2018

    Due to the monopoly of APIs, the production and supply of these drugs will be stopped in 2018

    • Last Update: 2019-01-08
    • Source: Internet
    • Author: User
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    In terms of 2018, there are countless cases of drug discontinuation due to the rising cost and shortage of APIs ▍ due to the monopoly of API, the price of chlorpheniramine has increased 50 times this year The media generally reported that the price of chlorpheniramine API has increased rapidly in a short period of time: it has increased from 260-280 yuan / kg at the end of last year to 15000 yuan / kg, which has increased 50 times The high price has led to the suspension of some drugs, which has aroused widespread concern of the society According to the investigation, one pharmaceutical enterprise in Hunan and one in Henan has a dominant position in the market of Chlorphenamine, which violates the relevant provisions of the anti monopoly law of the people's Republic of China In fact, such abuse of market dominance usually has serious consequences ▍ the involved pharmaceutical enterprises were fined ten million yuan by the State Administration of market supervision, which imposed administrative penalties on them according to law, and ordered two involved enterprises to stop their illegal acts; the illegal income of the Hunan Pharmaceutical Enterprises was confiscated 2.3947 million yuan, and the fine of 8% of the sales in the previous year was 8.4794 million yuan; the fine of 4% of the sales in the previous year was 1.5573 million yuan A total of 12.4314 million yuan was confiscated to the two enterprises involved in the case Taking chlorphenamine as an example, on the one hand, as a major chlorphenamine API supplier, once monopoly occurs, the supply of Chlorphenamine API will be tight and the price will rise; on the other hand, it is understood that chlorphenamine API is an important raw material for the production of more than 2000 commonly used drugs The behavior of the enterprises involved in the case leads to the shortage of supply of Chlorphenamine API, and the price will rise substantially Some downstream factories The availability of drugs has been greatly affected by the reduction of commercial production and the suspension of production Of course, it is not the first time for the state to rectify the shortage of APIs caused by monopoly On December 6, the State Administration of Market Supervision issued the news that "three manufacturers of glacial acetic acid API have been punished 12.83 million yuan for monopolistic behavior" After investigation, Chengdu Huayi pharmaceutical accessories manufacturing Co., Ltd., Sichuan Jinshan Pharmaceutical Co., Ltd and Guangdong Taishan Xinning Pharmaceutical Co., Ltd have reached a monopoly agreement since March 1, raising the sales price of glacial acetic acid API from 7-9 yuan / kg to 28-33 yuan / kg ▍ as we all know, the production and supply interruption of many drugs are well known The most direct impact of the monopoly of APIs lies in the price The sharp rise in the price leads to a shortage, which directly damages the interests of downstream operators, eliminates market competition, makes many drugs unable to supply, and finally stops production As for this year, there are countless cases of drug discontinuation due to the rising cost and shortage of APIs On December 12, Shanxi Pharmaceutical Machinery Co., Ltd issued the notice on publicizing the cancellation of the qualification of compound Amway capsule hanging on the net, which showed that due to the shortage of raw materials, the production of compound Amway capsule of Lepu pharmaceutical had stopped, so the enterprise applied for the cancellation of hanging on the net in Shanxi Province, and promised to cancel the hanging on the net and the supply nationwide On December 10, Ningxia Drug Purchase Center released relevant information, 47 drugs applied to cancel the qualification of Internet access in Ningxia, involving erdosten, Niuhuang Jiedu tablet, gastrodin and other varieties; two drugs, octreotide acetate injection and Zishenyutai pill, applied for rejection, one of the reasons is that the cost of raw materials is too high, and the price of drugs is low, resulting in losses On November 7, the office of Liaoning Provincial Leading Group for centralized procurement issued a notice on drugs in short supply Among them, 23 drug shortages were related to APIs: 15 drug enterprises were short of capacity due to raw materials, enterprise production line transformation and other reasons; 6 drugs were shut down because they could not purchase raw materials; 2 drugs could not be normally supplied due to the rising prices of APIs and low bid prices 。 The discontinued drugs include m-hydroxylamine heavy tartrate injection, lidocaine hydrochloride injection, aminocaproic acid injection, tropicamide eye drops, captopril tablets and isoniazid injection On September 17, Inner Mongolia Autonomous Region issued the notice on the announcement of Shanxi Yellow River traditional Chinese Medicine Co., Ltd and other enterprises applying for the disqualification of some drugs from the Internet 13 drugs from 5 pharmaceutical enterprises applied for the disqualification According to the notice, the reasons why 13 drugs are no longer available are the rise of API price, the transformation of production line, environmental pollution and other reasons, resulting in the suspension of drugs It is understood that 13 drugs, including Norfloxacin Capsules, Ibuprofen Tablets, Maxing Cough tablets and other regular drugs In September, a commercial company issued a notice that lidocaine hydrochloride capsules could not be supplied because the APIs could not be purchased Previously, it has been disclosed that the price of lidocaine hydrochloride injection, one of the indispensable important excipients, has soared more than 90 times In July, Liaoning Province announced that 42 drugs were cut off due to problems related to APIs 12 drugs have insufficient production capacity due to raw materials and other reasons; 13 drugs cannot purchase raw materials; 17 drugs cannot be supplied normally because the price of raw materials rises and the bid winning price is too low In May, Inner Mongolia issued a notice that due to the rise of raw materials and other reasons, 27 drugs from China and the United States, such as Squibb, Shiyao, Baiyunshan and other well-known pharmaceutical enterprises applied for the disqualification of Internet access, involving varieties such as pentoxifylline sustained-release tablets, captopril tablets, simvastatin tablets, etc Indeed, some experts in the industry once told the Economic Daily that the finished drugs corresponding to the APIs with high price rise are common anti allergy and anti cold drugs If these APIs continue to be "general distribution" and some enterprises are allowed to jointly monopolize them, the most direct result is the price rise of relevant drugs Under the background of the rising of APIs, many drugs are not willing to lose money due to the low bid price, which leads to the shortage of related drugs, drug companies default and other phenomena After the breach of contract, the bid will be abandoned, the qualification for winning the bid will be cancelled, and the performance bond will be deducted; the key will be included in the bad record, and the qualification for winning the bid of all products of the enterprise in the whole province will be cancelled, even kicked out of the provincial market for two years For pharmaceutical enterprises, they have to stop production and be punished by relevant departments; for the public, when the supply of commonly used drugs is cut off, people can only accept the unbearable pain of shortage In order to further standardize the API market environment and establish a fair competitive API purchase and marketing market environment, in November last year, the national development and Reform Commission issued China's first "guide to price behavior of drug shortage and API operators" to rectify the API monopoly But obviously, this is not enough We need more powerful laws and regulations.
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