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Nearly a century ago, the Chinese medicine formula granules developed by the "reformers" in the Chinese medicine community were finally recognized as the result of the effort of "modernization of Chinese medicine.。Under the multiple background of "zero addition" and quantity procurement of hospital drugs, Chinese medicine formula particles will still enjoy the "dividend" of Chinese medicine decoction pieces.。
After 28 years of "pilot", Chinese Medicine formula particles finally "positive"。
On February 10, 2021, the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine, the National Health Commission and the State Medical Insurance Bureau jointly issued an announcement announcing that the pilot work of traditional Chinese medicine formula granules, which has continued since 1993, will be terminated on November 1 this year。In the future, all Chinese medicine enterprises can produce Chinese medicine formula particles, the implementation of the filing system, no longer need to apply for approval。
This means that nearly a century ago, the Chinese medicine formula particles developed by the "reformers" in the Chinese medicine group were finally affirmed as the result of the "modernization of Chinese medicine" after twists and turns。
The 28 years of the pilot, like a person from birth to the process of standing, has been repeatedly examined。Chinese medicine formula particles, like a "thinking, not following the rules" child in the traditional Chinese medicine family, are constantly struggling in a variety of states such as being affirmed, doubted, entered into another register, and recognized。
It belongs to traditional Chinese medicine decoction pieces and enjoys the same "privilege" of protecting traditional Chinese medicine as traditional Chinese medicine decoction pieces: In the drug reform, there is no zero difference (price can be increased, and the price increase rate is limited to 25% in 2016), it is not assessed by the proportion of drugs, and it is even possible to enter secondary and above hospitals without bidding。
Compared with other Chinese medicine decoction pieces brothers and sisters, it is a bit "unpopular"。To protect the traditional Chinese medicine slices，The 2001 policy stipulates that TCM formula particles can only be used clinically in provincial secondary or higher medical institutions，The vast majority of township health centers, village clinics, community health service stations, and individual clinics are not qualified to use Chinese medicine formula granules - under the restriction of use，The sales volume of Chinese herbal formula granules accounts for only 10% of the total Chinese herbal slices market。
In clinical use, it is more popular than traditional Chinese medicine decoction pieces: In the large hospitals above secondary level that can use Chinese medicine formula particles, clinicians and patients tend to prescribe Chinese medicine formula particles that do not need to be fried, have a high degree of standardization and are portable, and its dosage is far higher than that of traditional Chinese medicine decoction pieces。
It and traditional Chinese medicine injection and other auxiliary drugs, in the traditional medical institutions to maintain medicine chronic diseases, was once a high kickback of corruption areas。This round of drug reform has vigorously cracked down on drug rebates with all kinds of killer mace such as drug collection and restriction of auxiliary drugs。
Today, under the multiple background of "zero addition" and quantity procurement of hospital drugs, Chinese medicine formula particles will still enjoy the "dividend" of Chinese medicine decoction pieces.。After liberalizing its production qualification and setting standards, where will it go？
Dispute over routes
The modernization of traditional Chinese medicine has been a controversial route for many years。As one of the representative works of Chinese medicine modernization, "Chinese medicine formula granule" is the first to sink and float in the debate of "whether the scientific Chinese medicine is recognized"。
Supporters believe that the modernization and science of traditional Chinese medicine can deepen people's understanding of the properties and pharmacology of traditional Chinese medicine, so that traditional Chinese medicine loses its mysterious name, and traditional Chinese medicine can guide the overall progress of traditional Chinese medicine through modern scientific analysis。
Opponents see it as a loss of tradition and a worship of foreign things。
Qiu Chenbo, the earliest practitioner of TCM modernization, was convicted of "counterrevolutionary crimes" by the Guangzhou Intermediate Court for "undermining the Party's TCM policy" and sentenced to two years of detention in 1960。
In the 1950s, as the director of Guangzhou Xingqun Chinese Medicine Refinery, Qiu Chenbo led Xingqun to quickly launch more than 200 Chinese medicine refining products, which were not only popular in hospitals and clinics across the country, but also sold to Southeast Asia。
An article in Beijing Traditional Chinese Medicine analyzed that these new dosage forms were popular in hospitals and clinics because "workers and peasants had no time to spend on decocting medicine in order to increase production."。
But the situation suddenly changed, at the National pharmaceutical industry conference in 1958, the discussion of traditional Chinese medicine refining agents was very warm, but the mainstream view is that the current reform is not appropriate, the reason is: the Party's traditional Chinese medicine policy is "inherit" and "carry forward".。The focus should now be on 'inheritance' rather than 'development'."。
This means that the direction of TCM modernization has been denied。
Until 30 years later, Japan, Taiwan have a large number of Chinese medicine particles listed, called "Han Fang particles", "scientific Chinese medicine", the process has been quite mature, in Japan, has formed a mature market with an output value of 40 billion。
中国业界发现，在中国大陆，“许多中药剂型改进药品的生产工艺设计及操作方法，基本上还停留在五十年代初期的水平”。
And China can only serve as a supplier of traditional Chinese medicine, located in the downstream of the industry。
The Chinese medicine community is once again aware of the need to improve dosage forms。Under the guidance of the policy, a new generation of TCM practitioners began to develop new TCM dosage forms again。
This time, traditional Chinese medicine granules took center stage。
After some sporadic exploration, in 1987, the Ministry of Health and the State Administration of Traditional Chinese Medicine issued Opinions on Strengthening the Development of Traditional Chinese Medicine Dosage Forms.。
"Opinions" pointed out that "we should actively use modern science and technology and means to strengthen the development of new dosage forms," such as making commonly used traditional Chinese medicine pieces into powder, granular。
Since then, the development of Chinese medicine formula particles has been mentioned in a very important position: the State Administration of Traditional Chinese Medicine will be a major scientific research project, but also included in the "spark plan" to further promote。
In November 2001, a national "Ninth Five-Year Plan" research project was completed, which for the first time put forward the national strategy of promoting the modernization of TCM industry in China。
The project is called "Strategic Research on the Promotion of Modern Chinese Medicine Industry".。The research team is highly qualified: the leading group consists of Li Zhenji, deputy director of the National Administration of Traditional Chinese Medicine; Li Boxi, Director and researcher of the Development Research Center of The State Council; Liu Yanhua, director of the Department of Rural and Social Development of the Ministry of Science and Technology; and Li Boxi is the project leader。
The research results point out that the development direction of TCM industry is "industrialization, scientific, modernization and internationalization".。Among them, the Chinese medicine dosage form with good effect, portable, convenient storage and casual clothes is considered to be "a strong guarantee to enhance market competitiveness and promote the modernization of Chinese medicine".。The study also pointed out that modern dosage forms can be developed to compare with botanicals and open up international markets。
Yifang Pharmaceutical and Tianjiang Pharmaceutical were identified as dosage form reform pilot units, supported by the Administration of Traditional Chinese Medicine and various ministries。The two companies cooperate with scientific research institutes and universities to carry out a variety of studies such as process improvement and clinical comparison of efficacy。
The development of Chinese medicine formula granules has since entered the fast lane。
Tangled pilot
In 2001, when the former State Food and Drug Administration designated six enterprises to pilot, the reason was that "due to many problems such as efficacy and measurement, there is no unified standard".。
At that time, one of the pharmaceutical and Tianjiang Pharmaceutical and other pilot units would not think that behind the development of traditional Chinese medicine formula particles seems to be greatly promoted, there is still a brand of traditional Chinese medicine and modern route game, this pilot is 28 years。
From 2002 to 2004, six pilot manufacturers of traditional Chinese medicine formula granules, such as Tianjiang Pharmaceutical, Yifang Pharmaceutical (later acquired by Tianjiang Pharmaceutical), Kangrentang, Sanjiu Pharmaceutical, Green Pharmaceutical, and Bili Pharmaceutical, obtained pilot qualifications, and no new pilot enterprises were approved at the national level。
14 years later, in 2016, provinces have the right to approval, and more than a dozen provinces have successively introduced their own pilot policies for TCM formula particles。However, pharmaceutical companies that have obtained qualifications from provincial government departments can only sell and use their products within the province。The industry is still not fully liberalized。By 2020, the six pilot enterprises will still occupy more than 80% of the market share。
In the long process of Chinese medicine formula granule pilot, the quality standards of the dispute, protracted。
Each factory has its own production standards, the quality is uneven, and the efficacy of many products cannot be guaranteed...As early as the 1950s, this was a widespread problem in Chinese medicine refiners such as extractum。
For a long time, in addition to the inconsistent production standards, there has been a controversy in the Chinese medicine industry around formula particles: whether there is a difference in efficacy between extracting various drugs to make traditional Chinese medicine formula particles, brewing them according to prescription when used, and extracting them to make compound granules after suffering together according to prescription？Compared with the effect of traditional Chinese medicine slices after suffering？
Many practitioners of Chinese medicine believe that the interaction of different components in the process of decocting medicinal materials is an important prerequisite for the effectiveness of Chinese medicine, and therefore question the efficacy of Chinese medicine formula particles。
From the "lung detoxification soup" frequently mentioned in this year, we can glimpse a corner of these disputes。
In January 2021, the State Administration of Traditional Chinese Medicine issued a special note, emphasizing that "' lung detoxification soup 'should be prepared with traditional Chinese medicine slices and decocted in water", and should not be prepared with single-flavor Chinese medicine formula particles, "so as not to reduce the efficacy and delay the treatment".。Some Chinese medicine enterprises use single Chinese medicine formula granules to prepare lung detoxification soup, which has been banned for many times。
In clinical use, Chinese medicine formula granules are also quite limited。Many provinces even clearly pointed out that Chinese medicine formula particles can only be used in provincial secondary or above (including secondary) medical institutions for clinical use, and the vast majority of township health centers, village clinics, community health service stations, and individual clinics are not qualified to use Chinese medicine formula particles。Traditional Chinese medicine, on the other hand, can be used in all medical institutions。
Gradually gaining the upper hand of Chinese herbal formula granules
In his nearly 30 years of medical career, a senior TCM doctor in Beijing's Top Three Hospital gradually found that in recent years, the proportion of TCM formula particles prescribed by his hospital has far exceeded the proportion of TCM slices that patients need to go home to cook。
He believes that the need to send patients home to complete the final process of drug processing, it is difficult to guarantee the effectiveness of the treatment。In the doctor's prescription, the dosage of traditional Chinese medicine slices is difficult to adjust because there is no unified standard。In addition to the quality of medicinal materials, the origin is not the same, sometimes the same recipe, for the same condition, some patients are effective, and some are ineffective。Too many chance factors give him a headache。
He gradually discovered that the Chinese medicine formula granules were very convenient when adjusting the dosage。"To what extent does the efficacy of patients need to be increased, through the adjustment of Chinese medicine formula particles, it is better to operate than to adjust traditional Chinese medicine pieces, because the dosage of formula particles is a standard?。And large manufacturers, the Chinese medicinal materials used for processing can be traced to the source, and the quality is guaranteed。
Compared with traditional Chinese medicine pieces that need to be time-consuming and laborious to cook at home, Chinese medicine formula particles are also more popular with patients。
Therefore, in the past 20 years, the growth rate and profits of Chinese medicine formula granules related enterprises are crazy。
For example, the net profit of Tianjiang Pharmaceutical, mentioned earlier, was 6.45 million yuan at the end of 2001, and soared to 5 million yuan in 2013.46亿元。In 2015, the listed company "China Traditional Medicine" spent 8.4 billion yuan to acquire Tianjiang Pharmaceutical。The announcement of "China Traditional Chinese Medicine" shows that in the first half of 2020, the sales volume of traditional Chinese medicine formula particles reached 45 percent.700 million yuan, gross margin of 68.7%。
Kangrentang, a pharmaceutical company that specializes in TCM formula pellets, was acquired by Hongri Pharmaceutical in 2010。In the following four years, the market value of Hongri Pharmaceutical increased from 5 billion yuan to 15 billion yuan。According to the announcement of Hongri Pharmaceutical, its gross profit margin of traditional Chinese medicine formula granules reached 76 in the first half of 2020.6%。
Health care corruption areas
The rapid expansion of the Chinese medicine formula granule market has also created a major disaster area for medical corruption:
A number of Chinese hospital directors across the country have been jailed for accepting bribes from sales of Chinese medicine formula granules。A large number of such cases can be found on the website of China Judgment Documents。
From 2007 to 2014, Li Junmin, president of Xiangcheng Hospital of Traditional Chinese Medicine, took advantage of his position to provide convenience in sales and payment of goods for Guangdong pharmaceuticals, and successively received a total of 189 kickbacks.2万元。In the end, Li Junmin was sentenced to 11 years in prison and fined 800,000 yuan。
Wei Guangping, president of Wenshan Hospital of Traditional Chinese Medicine in Yunnan Province, took advantage of her position as president from 2008 to 2018 to seek benefits for others in the process of drug and medical equipment procurement and fund allocation, and repeatedly accepted cash from relevant personnel of enterprises totaling 166 yuan.5万元。Among them, the salesman of Tianjiang Pharmaceutical traditional Chinese medicine formula granules bribed the hospital to make the products enter the hospital and sell more, and timely disburse the drug payment。
On June 16, 2015, Baise Hospital of Traditional Chinese Medicine in Guangxi Province and Yifang Company (pseudonym, note of judgment) signed the "Sales Contract of Traditional Chinese Medicine Formula Granules".。From 2015 to 2019, in order to thank Wang Guozhen for giving priority to the payment of goods, the business manager of one company, Liang Mou, sent cash to President Wang Guozhen ten times, totaling 300,000 yuan。
In 2015 and 2016, a number of heads or doctors of traditional Chinese medicine hospitals in Heilongjiang province were taken away for investigation by anti-graft authorities, including more than 20 hospital directors。At that time, there were media reports that they were involved in the problem of rebates for Chinese medicine formula granules。At the same time, the head of traditional Chinese medicine in Heilongjiang province resigned, complaining of illness。
The surge in manufacturers' performance and the spate of corruption cases come against the backdrop of the special status enjoyed by Chinese herbal formula granules。
No need for zero price difference, regardless of the proportion of medicine, the special status of Chinese medicine formula particles。
In 2001, TCM formula granules were officially positioned as "TCM decoction pieces".。That is to say, unlike proprietary Chinese medicines, TCM formula granules, which have been modernized and easy to use, enjoy the same treatment as traditional Chinese medicines that require long decoctions and complex use。
This includes:
Before a new Chinese medicine formula granule is marketed, it does not need to go through clinical trials and approval.。As long as the relevant medicinal materials are made into particles and the dosage form is changed, it can be counted as a new drug。Because the "new drug" enjoys a patent, pharmaceutical companies can set their own prices, so the price of formula particles is generally more than 40% higher than that of similar decoction pieces;
It also does not have to comply with the zero-price policy for drugs;
At the same time, it is not included in the proportion of drugs, and does not need to go through bidding and procurement to enter the hospital。
This has created a huge space for rent-seeking, and chaos is frequent。By 2016, the State Administration of Traditional Chinese Medicine had to issue a request: strictly implement the price increase rate of traditional Chinese medicine pieces controlled within 25%。
After the trial
As mentioned earlier, the relevant pharmaceutical factories have high profits for a long time, and there is another important reason: traditional Chinese medicine formula particles have been in the "pilot production" stage for a long time。From 2002 to 2004, six pilot manufacturers of traditional Chinese medicine formula granules, such as Tianjiang Pharmaceutical, Yifang Pharmaceutical (later acquired by Tianjiang Pharmaceutical), Kangrentang, Sanjiu Pharmaceutical, Green Pharmaceutical, and Bili Pharmaceutical, obtained pilot qualifications, and no new pilot enterprises were approved at the national level。
In 2016, because The State Council included Chinese medicine formula granules in the "Chinese Medicine Development Strategic Planning Outline 2016-2030", provinces have the right to approval, more than a dozen provinces have introduced their own pilot policies for Chinese medicine formula granules, and industry competition has increased。However, pharmaceutical companies that have obtained qualifications from provincial government departments can only sell and use their products within the province。The industry is still not fully liberalized。By 2020, the six pilot enterprises will still occupy more than 80% of the market share。
On February 10, 2021, a paper "Announcement on the end of the pilot work of Traditional Chinese Medicine formula particles" explained that the reason for the end of the pilot is: the industry has a certain market size, to standardize production and guide the healthy development of the industry。
However, the announcement mentioned that the relevant quality supervision is still included in the management of traditional Chinese medicine pieces。This means that the special treatment of Chinese medicine formula particles will still be retained。
This also means that under the background of "zero addition" and quantity procurement of hospital drugs, Chinese medicine formula particles will become one of the most advantageous varieties of all drugs - chemical drugs have the straitline of collection, the supervision level of proprietary Chinese medicine and chemical medicine is similar, and Chinese medicine decoction pieces are lagging behind The Times。
Many pharmaceutical representatives, because of the pressure brought by collection, have begun to turn to traditional Chinese medicine formulations that have left room for rent-seeking after most other drugs have no room for rent-seeking。
In the future, the Chinese medicine formula granule market will usher in an era of rapid growth, or fall into the quagmire of medical corruption, or a combination of both？
来源:@Eight o 'clock news Author: @Fang Shuchen | 
