December 20, 2024 Source: drugdu 42
Recently, after the announcement of the proposed winning results of the 10th national centralized drug procurement, the centralized procurement price of 3 cents a piece of aspirin attracted national attention as a "low price". The public's concern is largely due to the concern about whether the clinical efficacy of the drug can be guaranteed at a low price. So, can 3 cents produce a piece of qualified aspirin?
▍3 cents can produce
The answer is yes. "This price can be achieved through large-scale production. Since the raw materials of aspirin itself are relatively cheap and the excipients are not particularly expensive, if the equipment conditions are good and the output is large, its cost will also be reduced. It does not mean that when the price drops to a certain level, the product quality will be low and the company will cheat. This is a commercial behavior. The company takes the initiative to quote a low price for its own commercial purpose, either to occupy the market or for working capital. But no matter which company quotes, it should be carefully calculated." said an expert in the pharmaceutical field. Since 2018, the National Medical Insurance Administration has organized 10 batches of national drug procurement in conjunction with relevant departments, and has successfully purchased 435 drugs in total. Although ultra-low prices have appeared many times before, for example, in the third national procurement, the lowest winning bids for hypoglycemic drugs such as metformin and vildagliptin were 0.01 yuan and 0.38 yuan respectively. However, the low prices in the tenth procurement, which involved the largest number of varieties, exceeded the industry's expectations. It can be seen from the published catalog that the prices of enteric-coated aspirin tablets included in the procurement have all fallen. The cheapest price is 60 tablets of 100mg enteric-coated aspirin tablets, which only cost 2.06 yuan, that is, the price of each tablet has dropped to 3.4 cents. What is even more surprising is that the quotations for many injections are also less than 1 yuan, and even the price of a single injection is less than 2 cents. For example, the potassium chloride injection of Chenxin Pharmaceutical Co., Ltd., 10ml:1.5g specification is quoted at 0.16 yuan. Although generic drugs are known for their low prices around the world, such low prices will inevitably have a certain impact in the short term in my country, where the current production capacity is not concentrated enough and large-scale production has not been formed. "In fact, if companies voluntarily quote such low prices, this extremely low profit or even no profit will not last long, and it is also not good for the entire industry." said a person in charge of a pharmaceutical company. At the 2024 China Pharmaceutical Industry Development Conference, the number of pharmaceutical industrial enterprises above designated size in my country reached 13,000, while this number was only 8,337 at the end of 2021. In the United States, its generic drugs are highly concentrated. According to data, the three pharmaceutical companies in the United States produce 71% of injectable anti-tumor generic drugs; the three largest companies produce more than 91% of injectable parenteral nutrition solutions. "Enterprises with a full industrial chain will significantly reduce the price of the drugs they produce. Chinese pharmaceutical companies have always been in a state of large number and small scale, so future integration is imperative. And volume-based procurement has the possibility of triggering industry mergers and reorganizations. Only in this way can the price of Chinese generic drugs really come down." said the person in charge of the above-mentioned pharmaceutical company. At the same time, he believes that the concentration trend in the pharmaceutical field is already unfolding, and this low-price procurement model will further promote the survival of the fittest in the industry.
▍Can quality and efficacy be guaranteed?
3 cents of aspirin, "Can such a low-priced drug be effective?" undoubtedly touches the nerves of the public. So, is the aspirin produced at 3 cents effective? "For chemical drugs, as long as the structure of the raw materials is stable, the efficacy of most drugs has little to do with the preparations. Only a small number of chemical drugs have special properties and need special treatment. If the process is not in place, it may affect the efficacy. Most chemical drugs are the raw materials themselves that play the greatest role. Specifically, aspirin is an enteric-coated tablet. Its efficacy is greatly affected by gastric emptying and human physiological factors. The preparation itself has little effect on the efficacy." An expert involved in the consistency evaluation of generic drugs said. In fact, chemical tablets are one of the most common oral solid preparations, and their production process is relatively mature and standardized. It is also a dosage form with less difficulty among generic drugs. "If companies can supply large quantities at such a low price, and the quality of the test is qualified, I think there is no problem with its efficacy. This is the strength of China's manufacturing industry. In fact, more than 80% of generic drugs have fixed chemical compositions. As long as the chemical composition is qualified, the preparation process also follows the conventional process standards, and the test is completely qualified, it will not affect the efficacy. However, there is indeed a certain proportion of drugs that will be affected by some details such as the preparation process and excipients, which will cause problems with the efficacy." Wang Lifeng of Beijing Huiyao Consulting said. Wang Lifeng emphasized that although the level of China's pharmaceutical industry and pharmaceutical industry has greatly improved compared with 20 years ago, and the entire industry has implemented GMP, the national government departments still need to strengthen supervision on drug quality issues. At the "Promoting High-quality Development" series of thematic press conferences held by the State Council Information Office on September 13, Li Li, director of the State Drug Administration, announced a set of latest data: from January to August this year, a total of 20,969 batches of national drug sampling were carried out, with a qualified rate of 99.43%. "We will fully serve the overall situation of the national centralized procurement of drugs and medical devices, and implement 100% full coverage of the inspection of production enterprises and the sampling inspection of selected drugs and medical devices to ensure that the selected products will be "reduced in price but not in quality." Li Li said at the press conference.
▍Does low price affect innovation?
Low prices undoubtedly bring low profits for enterprises. According to conventional thinking, low profits will inevitably affect the innovation ability of Chinese pharmaceutical companies. After all, it is difficult to promote innovation without money. But is money an important factor affecting China's pharmaceutical innovation? "Money is not the only factor to measure the innovation ability of a pharmaceutical company. What is important is whether the pharmaceutical company has an innovative gene. In the past era of high drug prices, when pharmaceutical companies made extremely high profits, there was still little innovation in China, and even the work of consistency evaluation of generic drugs was carried out only after the country promoted it. Now, many companies with innovative genes are also doing innovation without money, and the benefits brought to them by innovative drugs encourage them to continue to innovate. Therefore, whether pharmaceutical companies innovate or not, don't use money as an excuse." A researcher in the field of medicine said. He also said that the current country needs to support innovative drugs more in terms of policies and optimize the innovation environment.
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