The Chinese medicine formula granules developed by the "reformers" in the TCM group nearly a century ago have finally been affirmed as the results of the efforts of "TCM modernization". Under the multiple backgrounds of "zero addition" and quantity procurement of hospital drugs, Chinese medicine formula granules will still enjoy the "dividends" of Chinese medicine tablets.
On February 10, 2021, the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine, the National Health Commission and the National Medical Insurance Bureau jointly issued an announcement announcing that the pilot work of Chinese medicine formula granules, which has been continued since 1993, will be terminated on November 1 this year. In the future, all Chinese medicine enterprises can produce Chinese medicine formula granules, implement the filing system, and no longer need to apply for approval.
This means that the Chinese medicine formula granules developed by the "reformers" in the TCM group nearly a century ago have finally been affirmed as the results of the "modernization of TCM" after experiencing twists and turns.
The 28 years of the pilot, like a person from birth to standing, has been repeatedly examined. Chinese medicine formula granules, like a child in the traditional Chinese medicine family who "has ideas and does not follow the rules", constantly struggles in a variety of states such as affirmation, doubt, entry into another book, and recognition.
It belongs to the Chinese medicine tablets, and enjoys the same "privileges" of protecting traditional Chinese medicine as the Chinese medicine tablets: in the drug reform, there is no zero price difference (the 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 can even enter the second-level hospital without bidding.
Compared with other Chinese medicine tablets siblings, it is a bit "unpopular". In order to protect the traditional Chinese medicine tablets, the 2001 policy stipulates that the chinese medicine formula granules can only be used clinically in provincial second-level or above (including secondary) medical institutions, and the vast majority of township health centers, village clinics, community health service stations, and individual clinics are not eligible to use Traditional Chinese medicine formula granules - under the restriction of use, the sales of Traditional Chinese medicine formula granules only account for 10% of the entire Chinese medicine tablet market.
In clinical use, it is more popular than traditional Chinese medicine tablets: in large hospitals that can use Chinese medicine formula granules above the second level, clinicians and patients tend to open Chinese medicine formula granules that do not need to be decocted, and the degree of standardization and portability of Chinese medicine formula granules is much higher than that of traditional Chinese medicine tablets.
△ Hospital pharmacist dispensing Chinese medicine granules (image from Visual China)
Together with auxiliary drugs such as traditional Chinese medicine injections, it was once a corruption disaster area with high kickbacks in the traditional medical institutions that used medicine to support doctors. This round of drug reform has vigorously cracked down on drug rebates with various killer tools such as drug collection and restriction of auxiliary drugs.
Nowadays, under the multiple backgrounds of "zero addition" of hospital drugs and procurement of quantities, Chinese medicine formula granules will still enjoy the "dividends" of Chinese medicine tablets. After liberalizing its production qualifications and setting standards, where will it go?
<h1 style="text-align: left;" > line dispute</h1>
The modernization of Chinese medicine has been a controversial route for many years. As one of the representative works of the modernization of Chinese medicine, the "Chinese medicine formula granules" are the first to sink into the debate of "whether the scientificization of Chinese medicine is recognized".
Proponents believe that the modernization and scientificization of Chinese medicine can make people deepen their in-depth understanding of the medicinal properties and pharmacology of Chinese medicine, so that Chinese medicine can lose its mysterious name, and Chinese medicine after modern scientific analysis can guide the overall progress of Chinese medicine.
Opponents see this as a loss of tradition and sublime.
Qiu Chenbo, the earliest practitioner of the modernization of Chinese medicine, was once sentenced by the Guangzhou Intermediate Court to "counter-revolutionary crimes" for "undermining the party's policy on traditional Chinese medicine" and sentenced to two years of control, that is, in 1960.
In the 1950s, as the director of the Guangzhou Xingqun Chinese Medicine Refinery, Qiu Chenbo led the Xingqunchang 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 the Beijing Journal of Traditional Chinese Medicine analyzed that these new dosage forms were welcomed by hospitals and clinics because "workers and peasants did not spend time decocting medicine in order to increase production."
At the 1958 National Pharmaceutical Industry Conference, the discussion on Chinese medicine extractants was very enthusiastic, "but the mainstream view is that it is not appropriate to carry out reform at present, on the grounds that the party's Chinese medicine policy is 'inherited' and 'carried forward'." The focus should now be on 'inheritance' rather than 'carrying forward'".
This means that the direction of modernization of Chinese medicine has been denied.
Until 30 years later, Japan and Taiwan have a large number of Chinese medicine granules on the market, named "Kampo granules", "scientific Chinese medicine", the process has been quite mature, in Japan, has formed a mature market with an output value of 40 billion.
The Chinese industry found that in the Chinese mainland, "many Chinese medicinal forms improved the production process design and operation methods of drugs, basically still at the level of the early 1950s."
China, on the other hand, can only serve as a provider of Chinese herbal medicines, located downstream in the industry.
The Chinese medicine community is once again aware of the need for dosage form improvement. Under the guidance of the policy, a new generation of Chinese medicine practitioners have once again begun to develop new Chinese medicine dosage forms.
This time, 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 the Opinions on Strengthening the Development of Chinese Medicinal Dosage Forms.
The "Opinions" pointed out that "it is necessary to actively use modern science and technology and means to strengthen the development of new dosage forms", such as making commonly used Chinese medicine tablets into powders and granules.
Since then, the development of Chinese medicine formula granules has been mentioned in a very important position: the State Administration of Traditional Chinese Medicine has set it up as a major scientific research project, and it has also been included in the "Spark Plan" to further promote it.
In November 2001, a national "Ninth Five-Year Plan" research project was completed, which for the first time proposed a national strategy for promoting the modernization of traditional Chinese medicine industry in China.
The project is called "Research on the Promotion Strategy of the Modernization Industry of Traditional Chinese Medicine". The research team is of high specifications: the leading group is composed of Li Zhenji, deputy director of the State Administration of Traditional Chinese Medicine, Li Boxi, director and researcher of the Development Research Center of the State Council, and Liu Yanhua, director of the Department of Rural and Social Development of the Ministry of Science and Technology, with Li Boxi as the project leader.
The research results point out that the development direction of the Chinese medicine industry is "industrialization, scientific, modernization and internationalization". Among them, the effective, portable, portable, convenient and convenient Chinese medicinal dosage forms are considered to be "a strong guarantee for enhancing market competitiveness and promoting the modernization of traditional Chinese medicine". The study also pointed out that modern dosage forms could be developed to open up international markets, compared with botanical medicines.
Fangfang Pharmaceutical and Tianjiang Pharmaceutical were identified as pilot units for dosage form reform, with the support of the Administration of Traditional Chinese Medicine and various ministries and commissions. The two enterprises cooperate with scientific research institutes and universities to carry out various research such as process improvement and clinical comparison of drug efficacy.
The development of chinese medicine formula granules has since entered the fast lane.
<h1 style="text-align: left;" > tangled "pilot."</h1>
In 2001, when the former State Food and Drug Administration designated six enterprises to carry out the pilot, the reason was that "there is no unified standard due to many problems such as efficacy and measurement".
At that time, how could the pilot units such as Fangfang Pharmaceutical and Tianjiang Pharmaceutical think that behind the seemingly vigorous promotion of the development of Traditional Chinese Medicine Formula Granules, there is still a brand of traditional Chinese medicine route and modern route game, and this pilot is 28 years.
From 2002 to 2004, 6 pilot manufacturers of Traditional Chinese medicine formula granules, including Tianjiang Pharmaceutical, Yifang Pharmaceutical (later acquired by Tianjiang Pharmaceutical), Kang Rentang, Sanjiu Pharmaceutical, Green Pharmaceutical, and Beli Pharmaceutical, obtained pilot qualifications, and since then, no new pilot enterprises have been approved at the national level.
14 years later, in 2016, the provinces had the right to approve, and more than a dozen provinces successively introduced the pilot policy of traditional Chinese medicine formula granules in their provinces. However, pharmaceutical companies that have obtained qualifications from provincial government departments can only sell and use their products within the scope of the province. The industry is still not completely liberalized. By 2020, the six pilot companies will still occupy more than 80% of the market share.
△ The picture is from People's Vision
In the long process of piloting Chinese medicine formula granules, the dispute over quality standards has been 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 with traditional Chinese medicine refining agents such as extracts.
For a long time, in addition to the inconsistency of production standards, there has been a controversy within the Chinese medicine community around the formula granules: is there a difference in the efficacy of extracting various drugs separately to make Chinese medicine formula granules, brewing according to the prescription when used, and extracting them after suffering together with the prescription to make compound granules? Compared with the effect of traditional Chinese medicine tablets after boiling?
Many practitioners of traditional Chinese medicine believe that the interaction of different components in the process of co-decoction of medicinal materials is an important prerequisite for the realization of the efficacy of traditional Chinese medicine, and therefore question the efficacy of chinese medicine formula granules.
From the "lung cleansing and detoxification soup" that has been frequently mentioned for more than a year, we can glimpse the corner of these controversies.
In January 2021, the State Administration of Traditional Chinese Medicine issued a special note emphasizing that "'lung clearing and detoxification soup' should be mixed with traditional Chinese medicine tablets and decoction", and single-flavor Chinese medicine formula granules should not be used to mix, "so as not to reduce the efficacy and delay treatment". Some Chinese medicine enterprises use single-flavor Chinese medicine formula granules to prepare lung detoxification soup, which has been banned many times.
In clinical use, Chinese medicine formula granules are also quite limited. Many provinces even clearly pointed out that Chinese medicine formula granules can only be used clinically in provincial second-level or above (including second-level) medical institutions, and the vast majority of township health centers, village clinics, community health service stations, and individual clinics are not eligible to use Traditional Chinese medicine formula granules. Traditional Chinese medicine tablets, on the other hand, can be used in all medical institutions.
<h1 style="text-align: left;"> chinese medicine formula granules that gradually gained the upper hand</h1>
A senior TCM doctor in Beijing's top three hospitals, in his nearly 30 years of medical career, gradually found that in recent years, the proportion of Chinese medicine formula granules issued by his hospital has far exceeded the need for patients to go home and cook Chinese medicine tablets.
He believes that it is difficult to ensure the efficacy of patients who need to go home to complete the last process of drug processing. In the doctor's prescription, the traditional dose of Chinese medicine tablets is difficult to adjust because there is no unified standard. In addition, the quality and origin of medicinal materials are not the same, and sometimes the same formula is effective for the same disease, and some patients are ineffective. Too many accidental factors give him a headache.
He gradually discovered that chinese medicine formula granules are very convenient when adjusting the dosage. "To what extent the patient's efficacy needs to be increased, it is better to adjust the chinese medicine formula granules than to adjust the traditional Chinese medicine tablets, because the dosage of the formula granules has a standard." Moreover, large manufacturers, the Chinese herbal medicines used for processing can be traced back, and the quality is guaranteed.
Compared with the traditional Chinese medicine tablets that need to go home and take time and effort to boil, Chinese medicine formula granules are also more popular with patients.
Therefore, in the past 20 years, the growth rate and profits of enterprises related to Traditional Chinese medicine formula granules have been crazy.
For example, the aforementioned Tianjiang Pharmaceutical, the net profit at the end of 2001 was 6.45 million yuan, and in 2013 it soared to 546 million yuan. In 2015, China Traditional Chinese Medicine, a listed company, acquired Tianjiang Pharmaceutical for 8.4 billion yuan. According to the announcement of "China Traditional Chinese Medicine", in the first half of 2020, the sales of Chinese medicine formula granules reached 4.57 billion yuan, with a gross profit margin of 68.7%.
Kang Rentang, a pharmaceutical company specializing in traditional Chinese medicine formula granules, 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 76.6% in the first half of 2020.
<h1 style="text-align: left;" > the hardest hit area of medical corruption</h1>
At the time of the rapid expansion of the Market for Traditional Chinese Medicine Formula Granules, a hard-hit area of medical corruption has also been bred:
The president of a number of traditional Chinese medicine hospitals across the country has been imprisoned for accepting bribes from chinese medicine formula granule salesmen. On the Chinese judgment documents network, a large number of such cases can be searched.
From 2007 to 2014, Li Junmin, president of Xiangcheng City Hospital of Traditional Chinese Medicine, took advantage of his position to provide convenience for Guangdong Yifang Pharmaceutical in terms of sales and payment for goods, and received a total of 1.892 million yuan in kickbacks. In the end, Li Junmin was sentenced to 11 years in prison and fined 800,000 yuan.
Wei Guangping, president of WenshanZhou Traditional Chinese Medicine Hospital in Yunnan Province, took advantage of her position as president to seek benefits for others in the process of drug and medical device procurement and fund allocation, and repeatedly accepted cash from relevant personnel of the enterprise totaling 1.665 million yuan. Among them, the Chinese medicine formula granule salesman of Tianjiang Pharmaceutical paid bribes to make the products enter the hospital and sell more, and to allocate the drug money in a timely manner.
On June 16, 2015, The Traditional Chinese Medicine Hospital of Baise City, Guangxi Province, and a company (pseudonym, note in the judgment) signed the "Sales Contract for Chinese Medicine Formula Granules". From 2015 to 2019, in order to thank Wang Guozhen for giving priority to the settlement of payments, Liang Mou, the business manager of one company, 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 by the anti-corruption department for investigation, including more than 20 presidents of traditional Chinese medicine hospitals. At that time, there were media reports that they were all involved in the issue of drug rebates for Chinese medicine formula granules. At the same time, there was also a president of traditional Chinese medicine in Heilongjiang Province who said that he resigned from illness.
The rapid growth of manufacturers' performance and the emergence of corruption cases are set against the backdrop of the special status enjoyed by Chinese medicine formula granules.
There is no need for zero price difference, not included in the proportion of drugs, and the special status of Chinese medicine formula granules.
In 2001, the Chinese medicine formula granules were officially positioned as "Chinese medicine tablets". That is to say, unlike proprietary Chinese medicine, modernized and easy-to-use drugs such as Chinese medicine formula granules enjoy the same treatment as traditional Chinese medicines that require long-term decoction and use of complex traditional Chinese medicines.
This treatment includes:
Before a new Chinese medicine formula granule is launched, it does not need to go through clinical trials and approvals [confirmation]. As long as the relevant medicinal materials are made into granules and the dosage form is changed, it can be counted as a new drug. Since the "new drug" enjoys patents, pharmaceutical companies can set their own prices, so the price of formula granules is generally higher than that of similar drinking tablets by more than 40%;
Zero price difference policy for drugs, which it also does not need to comply with;
At the same time, it is not counted in the proportion of drugs, and it can enter the hospital without bidding for procurement.
This has created a huge rent-seeking space, and there is frequent chaos for a while. By 2016, the State Administration of Traditional Chinese Medicine had to issue a document requiring that the price increase rate of Chinese medicine tablets be strictly controlled within 25%.
<h1 style="text-align: left;" > after the pilot ends</h1>
As mentioned earlier, the relevant pharmaceutical factories have long-term high profits, and there is another important reason: chinese medicine formula granules have been in the "pilot production" stage for a long time. From 2002 to 2004, 6 pilot manufacturers of Traditional Chinese medicine formula granules, including Tianjiang Pharmaceutical, Yifang Pharmaceutical (later acquired by Tianjiang Pharmaceutical), Kang Rentang, Sanjiu Pharmaceutical, Green Pharmaceutical, and Beli Pharmaceutical, obtained pilot qualifications, and since then, no new pilot enterprises have been approved at the national level.
In 2016, due to the State Council's inclusion of Chinese medicine formula granules in the "Outline of the Strategic Planning for traditional Chinese Medicine 2016-2030", the provinces had the right to approve, and more than a dozen provinces successively introduced the pilot policies of traditional Chinese medicine formula granules in their provinces, and the competition in the industry increased. However, pharmaceutical companies that have obtained qualifications from provincial government departments can only sell and use their products within the scope of the province. The industry is still not completely liberalized. By 2020, the six pilot companies will still occupy more than 80% of the market share.
On February 10, 2021, a paper "Announcement on Ending the Pilot Work of Traditional Chinese Medicine Formula Granules" explained that the reason for ending the pilot was that the industry had a certain market size, and it was necessary 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 Chinese medicine tablets. This means that the special treatment of Chinese medicine formula granules will still be retained.
This also means that in the context of "zero addition" of hospital drugs and procurement, Chinese medicine formula granules will become one of the most advantageous varieties of all drugs - chemical drugs have the tight curse of collection, the regulatory level of proprietary Chinese medicines and chemical drugs is comparable, and Chinese medicine tablets lag behind the times.
Many medical representatives, because of the pressure brought about by the collection, have begun to turn to the Chinese medicine formula that has left the rent-seeking space that is still retained after most other drugs have no rent-seeking space.
In the future, will the Chinese medicine formula granule market usher in an era of rapid growth, or will it fall into the quagmire of medical corruption, or both?
Fang Shuchen
Wang Chen and Xu Zhuojun | responsible editors
This article was first published on the WeChat public account "Eight Points Health" (ID: HealthInsight)
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