Pharmaceutical enterprises call for the implementation of the filing system for API to reduce costs
Release Time: 2018-12-15 10:00:24 Visited: 17148 times
The production of drugs is based on the API. Whether the API is in short supply or in high price, it has a direct impact on the pharmaceutical enterprises and drug prices.
"Now the price of raw materials has been increased by 20 times, 30 times or even 100 times, making it impossible for us to produce them ourselves." Hu Jiqiang, deputy to the National People's Congress and chairman of Zhejiang conbe group, said at the "voice · responsibility" forum recently.
API refers to the raw materials used in the production of various preparations. It is the active ingredients in preparations, such as medicinal powder, crystal, extract, etc., which are prepared by chemical synthesis, plant extraction or biotechnology, but cannot be taken directly by patients. At present, there are two sets of requirements for the production of drugs (including preparations and APIs) in China. One is the approval number, the other is GMP certification.
However, due to the reduction of API approval documents, it is very difficult to approve, which leads to the scarcity of API.
On February 14, 2017, Meng Yingjun, 25, published a rescue message on her micro blog. Because she suffered from a rare disease of hepatolenticular degeneration, she needed to take a drug called "penicillamine tablets" for a long time. And the production enterprises responded like this: because of the GMP upgrade problem, the raw material suppliers could not supply raw materials, so they would stop production.
"The monopoly of API is becoming more and more intense in the industry, forcing some commonly used low-cost drugs to stop production or prices skyrocketing. Although the state has taken corresponding measures to crack down on monopoly, it has little effect. For example, the price of vitamin B6 has increased from 150 yuan / kg to 980 yuan / kg, and the price of glucuronide has increased from 210 yuan / kg to 8000 yuan / kg. " Xiong Weizheng, deputy to the National People's Congress and chairman of Henan Lingrui group, said in an interview.
The reason for the high price of API lies in the fact that the supply of API is less than the demand. Since the API manufacturers must be approved by the relevant national departments before they can produce, and the number of approved manufacturers is small, once the manufacturers secretly form an alliance or dealers form an alliance to control the supply of API in the market, the price of API will be artificially raised.
On the one hand, the price of API increases in groups; on the other hand, the collective price reduction of national drug bidding makes the pharmaceutical enterprises in the middle in a dilemma. As soon as the price of drug bidding decreases, the drugs disappear, and the lack of cheap drugs has become an indisputable fact.
"Now the irrational price rise of API has become very ridiculous. According to our investigation, many problems are caused by the approval system adopted by the regulatory authorities for the review of API. Only after the review and approval can the API be produced, and those without approval cannot be produced. Dealers are driving up prices, some ordinary raw materials are going up, and many enterprises are unable to produce them. This is a serious situation. I hope the relevant departments will pay attention to it. " Xiong Weizheng appealed.
Geng Funeng, deputy to the National People's Congress and chairman of Sichuan Haoyi Pharmaceutical Group Co., Ltd., found that since the state liberalized drug prices, the prices of some drugs have risen, and the increase in drug prices caused by the monopoly of API is one of the main factors. Among them, there are two cases: one is the API with few number; the other is the wrong number of some Chinese herbal extracts, Chinese herbal pieces and pharmaceutical accessories.