The special rectification of Chinese medicine decoction pieces has come and enterprises are facing higher challenges

Medical Network March 16 hearing
Pieces quality should be improved
March 15, drug intellectual network released the "2020 Drug substandard quality data in the report" substandard quality of drugs in 2020 to collate data analysis
.
The report shows that Chinese herbal medicines are still the most in the data of drug unqualified in 2020
.
Among the 1481 batches of unqualified drugs, 1074 batches of Chinese medicinal materials were unqualified, accounting for 72.
52%
.
In addition, judging from the list of companies with unqualified drug quality in the past two years, the top companies have always been Chinese herbal medicine-related companies
.
(Image source: Yaozhi.
com) From the perspective of drug quality testing items, among the Top 10 unqualified items, the problem of unqualified character and content determination is the most prominent, and the number of characters that do not meet the requirements is 567 batches (accounting for 37%), ranking first ; The number of assays that did not meet the requirements reached 331 batches (accounting for 21%), ranking second
.
From the perspective of the types of medicines, in 2020, the quality of unqualified medicines is mostly Chinese medicinal materials.
The top 10 Chinese medicinal materials are 8 kinds.
"Qianhu" takes the top spot with 36 batches.
"Yam", "Wujiapi" and "Baixian" Pi" and "Epimedium" are ranked 2 to 5 respectively
.
(Image source: Yaozhi.
com) There are many reasons for this phenomenon
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The first is that the quality of Chinese medicinal materials used as the raw material of Chinese herbal medicines has caused quality problems
.
This is mainly due to the fact that in the process of traditional Chinese medicinal materials from wild varieties, the properties and internal chemical components of the medicinal materials are quite different from those of wild products due to various improper operations.
For example, there is no fibrous leaf sheath at the root and stem of the cultivated Peucedanum.
Residues, but membranous leaf sheath residues, the content of index components is difficult to pass
.
At the same time, the processing process of related enterprises is not standardized, and even illegal dyeing and excessive sulfur fumigation will affect the quality of traditional Chinese medicine decoction pieces
.
Excessive sulfur fumigation such as Angelica dahurica, chrysanthemum, lotus seeds, polygonatum, etc.

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It is understood that the phenomenon of moisturizing and soaking medicinal materials with sodium metabisulfite solution has appeared in the market to achieve the purposes of bleaching and mothproofing; in addition, some "desulfurization" technologies adopted to evade supervision have also appeared
.
Not only that, the Chinese medicine market is also flooded with a large number of counterfeit products, disrupting the market order
.
Among them, the phenomenon of adulteration is mainly concentrated in the varieties with few genuine sources and scarce resources, most of them are similar species or varieties with similar names and traits, such as the mixed use of ginseng and yam, or the use of inorganic salts, silt and other substances to increase traditional Chinese medicine The illegal behavior of the weight of raw materials and decoction pieces, such as white fresh peel
.

　　Chinese Herbal Medicine conducted more special rectification
In fact, the presence of Chinese Herbal Medicine for national market issue has been very seriously, in June 2020, the State Pharmaceutical Administration forwarded Heilongjiang provincial government issued "on the promotion of the implementation of inheritance and innovation development of Chinese medicine Opinions, to accelerate the promotion of the inheritance and innovation and development of traditional Chinese medicine, which emphasizes the relevant requirements for improving the quality of traditional Chinese medicine and promoting the development of the industry
.
Recently, with the implementation of the 2020 edition of the Pharmacopoeia, various localities have begun special rectification of Chinese herbal medicine
.
A few days ago, the Yanbian Prefecture Market Supervision Administration issued an announcement to carry out special random inspections on units using Chinese herbal medicines within its jurisdiction, further strengthen the supervision and management of Chinese herbal medicines, standardize the business order of Chinese herbal medicines, and crack down on illegal acts of using fake and inferior Chinese herbal medicines
.
On the same day, the Guiyang City Market Supervision Administration issued an announcement on the Kaiyang County Market Supervision Bureau to launch a special rectification action for Chinese herbal medicine
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Coincidentally, the Baoding Municipal Market Supervision Bureau recently used the "four enhancements" to further strengthen the investigation of hidden dangers of Chinese herbal decoction pieces production enterprises
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In addition, Tianshui City Market Supervision and Administration Bureau recently issued an announcement on solidly advancing the special rectification of decoction pieces of Chinese medicine.

.
In addition, on March 9th, the Bozhou Chinese Medicinal Materials Market also issued the "Notice on the 3.
15 Special Remediation of the Bozhou Chinese Medicinal Materials Specialized Market".
In order to standardize the market operation order and promote the prosperity and stability of the market, from March 5, 2021 to 2021 On April 5, Kangmei (Bozhou) Huatuo International Chinese Medicine City launched a special rectification action for the comprehensive management of the 3.
15 Chinese herbal medicine professional market for a period of one month
.
In accordance with the requirements of the "Ten Prohibitions" and "Ten Uniformities" in the professional market of Chinese herbal medicines, severely crack down on illegal processing, counterfeiting, and sales of counterfeit products
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At present, due to policy support and the impact of the epidemic, traditional Chinese medicine has ushered in a historic development opportunity
.
Regulatory departments continue to promote the rectification of the decoction pieces industry, and the traditional Chinese medicine industry is ushering in a round of major changes
.
In medicine is the material basis of the pharmaceutical industry, to strengthen quality control of traditional Chinese medicine, it is the inevitable road of development of Chinese medicine
.
Decoction pieces of Chinese medicine are one of the three pillars of China's traditional Chinese medicine industry, and the market development space is broad
.
In the context of increasing population aging and driven by policies supporting the development of Chinese medicine, it is estimated that the industry market size will exceed 500 billion yuan in 2023
.
In this context, the standardization, centralization, and healthy development of the industry is very important
.

　　Enterprises are facing higher challenges.

Generally speaking, with the strengthening of quality supervision of Chinese herbal medicines and decoction pieces, the overall quality of TCM decoction pieces has been significantly improved
.
Judging from the comparison of national market quality sampling data from 2013 to 2019, the overall qualification rates of Chinese herbal medicines and decoction pieces are 64%, 68%, 75%, 77%, 84%, 88%, and 91%, showing an increase year by year.
Steady and positive development trend
.
(Image source: Yaozhi.
com) With the promulgation of the new version of the "Drug Administration Law", the state has imposed unprecedented penalties on companies for cases of counterfeit and inferior products.
Increased intensity
.
Previously, due to the widespread distribution of Chinese medicinal materials and the current circulation status, managers were in the light, and the managed persons were in the dark and scattered in all corners and links.
The Chinese medicinal materials circulation industry lacked intensive, systematic and brand concepts.
, Resulting in the industry’s difficulty in unified management and standardization of circulation, thereby giving criminals a chance to take advantage of it
.
This chaotic situation will cause bad coins to drive out good coins
.
Because planting green medicinal materials, authentic medicinal materials and establishing a brand will inevitably increase costs or even reduce output.
For example, the output of green Codonopsis must not exceed the "Strong Root Spirit" Codonopsis pilosula, resulting in the failure of green organic medicinal materials to enter the market.
The use of informal means to vicious competition will inevitably make the price of medicinal materials unable to truly reflect their value
.
The new edition of the Pharmacopoeia puts forward strict management requirements for Chinese herbal medicine growers, Chinese herbal medicine raw material collection companies, and Chinese herbal medicine processing and distribution companies in the Chinese herbal medicine decoction pieces industry.
Under this background, Chinese herbal medicine decoction pieces enterprises are under obvious pressure and need to start from planting, processing, and All links are strictly controlled to ensure the quality and safety of traditional Chinese medicine
.
The industry predicts that the high-quality development of traditional Chinese medicine decoction pieces has become a trend, and the rectification of the traditional Chinese medicine decoction pieces industry will continue to increase in the future
.
However, I believe that the dilemma of Chinese medicinal materials and Chinese medicinal pieces is temporary.
With the steady advancement of a series of national policies such as pollution-free planting and the establishment of a traceability system, the quality of Chinese medicinal materials will be more comprehensively controlled
.
Under this circumstance, some unqualified decoction pieces enterprises, especially those that cannot adjust production and operation strategies and improve product quality in a timely manner, will be eliminated at an accelerated pace, and powerful enterprises will have a broader space for development.
The overall quality of the decoction pieces industry will be substantially improved
.