Recently, the price of API has begun to rise greatly. Data show that roxithromycin has risen faster since the second quarter of this year, from 590 yuan / kg in May to 735 yuan / kg in October.

Since the state strictly controls the environmental protection, not only a large number of raw material pharmaceutical enterprises which are not qualified for environmental protection have been shut down, but also a large number of small pharmaceutical enterprises unable to bear the environmental protection costs have also started to stop production or shut down. For example, as a national high-tech enterprise, Teri pharmaceutical, named by environmental protection supervision team twice, has the production capacity of tylosin and tmexin as the first in the world. During the period of this year's central environmental protection supervision group stationed in Ningxia to "look back", a company of Teri pharmaceutical was named "suspected of surface rectification". From July 17 to 20, Teri pharmaceutical once issued three consecutive articles saying that some colleagues falsely reported, falsely spread the company's "secret production, stealing odor" and other remarks, and used the name of environmental protection to fight competitors. On August 16, the inspection team of Ningxia Hui Autonomous Region found that Teri pharmaceutical did not stop production and rectification, but produced the same. 7 fermenters that Teri pharmaceutical has been restored to production illegally without authorization are emptied and sealed overnight.

The rise in the price of APIs now seems to be a common and natural thing“ The pressure of environmental protection is great and the "increase of large amount of expenditure due to improving environmental protection technology" has become the reason for many enterprises to rise their prices. The "pot" of rising price is regarded as being carried by environmental protection. But is it really because of the environmental protection?

1. why "monopoly" is falling

The price of the "rocket speed" rising API may be "human disaster" in addition to "natural disaster".

Some people familiar with the matter said that at present, some of the monopoly of APIs, many of them are controlled by people. One mode is to indirectly control several natural persons to purchase approval documents, and divide the market of the API into their own "circle", and only one of them will be allowed to produce, and the rest of the approval documents will be idle, resulting in monopoly market and then price increase. Another mode is to sign the "national general underwriting agreement" between the third-party commercial company and API enterprises, and to gather all the raw materials together. If we want to buy API, we can only buy through the channels provided by the company, while API enterprises cannot participate in pricing, thus creating monopoly.

Perhaps some people wonder, this has caused monopoly phenomenon, why the national regulatory authorities do not go to governance?

Some regulatory authorities have noticed that an enterprise has monopoly suspicion on a API, but after a layer of inspection, it is found that the production approval of the API has been purchased by dozens of people who seem to have no connection with the enterprise. Such a situation can not lead to monopoly judgment, so it can not be. Some of the APIs sold through third-party commercial companies can only find the third party with little correlation. But this mode has a long history. It is not uncommon in China. The price difference and huge profits brought by monopoly make some companies take risks.

According to the price supervision and inspection of the national development and Reform Commission and the information previously released by the Anti-monopoly Bureau, there are about 1500 kinds of API in China, but the production of which is in the hands of a few production enterprises, of which only one enterprise can produce 50 APIs, 44 APIs can be produced by only two enterprises, and only 3 enterprises can produce 40 APIs.

Insight database shows that the price of many first-aid drugs was relatively stable before 2013, and only slightly increased after 2013. But in 2018, some drugs rose more than 10 times. At the same time, there is a shortage of commonly used drugs in some places. On October 25, Heilongjiang health and Planning Commission issued a notice of Heilongjiang Province on launching the third batch of shortage and other online drug transactions in 2018, with 200 drugs in urgent need.

On October 31, Shanghai Sunshine pharmaceutical purchasing network issued the notice on online procurement of clinical short-term drugs such as nitroglycerin injection. 24 drugs were in clinical shortage, and will be purchased online. Previously, the website released "the second batch of commonly used low-cost drugs online procurement of Shanghai in 2018 without releasing the drug description", and more than 30 common drugs were considered to have increased too much, including chlorophenamine maleate tablets, Niuhuang Jiedu Tablets, Banlangen Granules, Baohe pills, Jianpi pills, vissin B6, metformin hydrochloride tablets, etc.

Take the paracetamine, a common cold medicine, as an example, in the first half of this year, once in a short month, the price rose from 400 yuan / kg to 23300 yuan / kg, up 58 times. But there are only 7 enterprises with production approval in poulmin, but only two production enterprises, and the rest of the approvals are idle. In December, Shenyang was reported to produce chlorophenamine maleate illegally, and was verified by the former State Food and Drug Administration and was withdrawn GMP (product production quality management standard) certificate. Since then, the price of paracetamine APIs began to rise gradually.

It is not difficult to find that even if there is environmental pressure, the monopoly is the reason for the current surge of API. Last year, the national development and Reform Commission also issued the guide for the price behavior of drug shortage and API operators to further regulate the market price behavior of the shortage drugs and APIs and maintain the market price order. On July 31st, 2017, the official website of the national development and Reform Commission issued a news that it fined two pharmaceutical enterprises with isoniazid drug price monopoly, totaling 443900 yuan. However, it is very limited to punish monopoly pharmaceutical enterprises or issue documents. For example, the two monopoly pharmaceutical companies will only be fined 443900 yuan. These fines may not touch the pain of the enterprises for the benefits that monopoly can bring. And there are policies and countermeasures. Maybe, we should think about the governance of monopoly, law and regulation.

2. the related review is still on the way

Some experts have suggested that, in addition to strictly monitoring monopoly through information technology, it is more important to create a better system environment for API approval, further learn from the practice suitable for the national conditions in the DMF of the United States, and better make the approval and production of APIs related to the finished drugs.

What is the relevance review?

In short, if the API of an enterprise is approved by the association with a preparation enterprise, other pharmaceutical companies often recognize the quality of their APIs. And this is conducive to the strength of the raw material enterprises to grow stronger, eliminate small and scattered API enterprises.

On October 8th, 2017, the general office of the Central Committee of the CPC and the general office of the State Council issued the opinions on deepening the reform of the review and approval system to encourage innovation of medical devices for drugs, which clearly proposed that the approval of drug and raw and auxiliary materials and packaging materials should be carried out, and the approval standard number of API will not be issued, and the holders of drug listing license shall not issue the API used for the production of preparations Be responsible for the quality of medical auxiliary materials and packaging materials.

In November 30, 2017, the announcement on adjusting the review and approval of API, medical auxiliary materials and drug packaging materials issued by CFDA (No. 146, 2017) made preliminary details on the requirements of "implementing the related review of raw and auxiliary materials" in the two documents. The "publicity platform for registration information of APIs, auxiliary materials and drug packaging materials" on CDE website was also opened, It means that the era of registration of Chinese api and DMF filing officially comes.

This is a process of opportunity and challenge for API enterprises, and good money expel inferior currency. Firstly, the threshold of original review and approval was raised. After the related review and approval, the API was approved together when the preparation was approved. For the API industry which is already in the wind and rain, concentration will be improved, small enterprises will be eliminated, and those enterprises with technical and financial forces will be developed rapidly. This industry, perhaps ushers in a shuffle.

However, because "API, medical auxiliary materials and packaging materials are reviewed and approved together when approving drug registration application, and no longer issue approval number of API", will there be "No. 1 difficult to ask" for the approval document for the current approval document of API or only a few API varieties with approval documents, and the situation of hoarding is strange? Whether the market will be monopolized and then the price will rise again.

The relevance review is a general principle in the world. The pace of China's international integration is just beginning, and the problems facing it need to be solved. It is still a long way to go to realize the original intention of standardizing the market.