At present, the cause of traditional Chinese medicine is showing a good development trend
.
According to the statistics of the national pharmaceutical industry, the main income of the Traditional Chinese medicine industry in 2021 has approached 700 billion yuan
.
In addition, with the implementation of a series of documents such as the "National Authentic Medicinal Materials Production Base Construction Plan" and the "Good Management Practice for the Production of Chinese Medicinal Materials", as well as strict supervision and special rectification, the production quality of Chinese herbal medicines has been continuously improved
.
According to the 2021 national drug sampling annual report of the State Food and Drug Administration, the total pass rate of chinese medicine tablet sampling has reached 98%.
Chinese medicine tablets for China's traditional Chinese medicine industry one of the three pillars, with the aging of the population and, driven by favorable policies, the industry development speed is fast, the market size is large, but due to the backward standards of some medicinal materials, unscientific cultivation of traditional Chinese medicine, low-cost and low-quality small workshops and regulatory means are not accurate enough, in the past, there have been long-term production and sale of counterfeit and illegal processing of traditional Chinese medicine tablets in the market, disrupting the order of Chinese herbal medicine business, which is not conducive to the long-term healthy development
of the industry.
In order to purify the Chinese herbal medicine market, in February 2020, the State Food and Drug Administration issued the "Special Rectification Work Plan for Chinese Medicine Tablets", which put forward the overall objectives and work points for the special rectification of Chinese medicine tablets nationwide, and then successively introduced local special rectification work plans for Chinese medicine tablets, strengthened the frequency of sampling inspections, named and exposed unqualified pharmaceutical enterprises, and further standardized the development of
the industry.
For example, on August 17, the Anhui Provincial Food and Drug Administration issued an announcement that 7 enterprises with traditional Chinese medicine tablets (including formula granules) had project defects, of which 5 enterprises had a deadline for rectification, and 2 enterprises suspended production, warnings and interviews
.
On August 11, the Sichuan Food and Drug Administration issued a notice on the non-compliance of 6 batches of drugs, and the 6 pharmaceutical companies that were "named" were all enterprises that produced Chinese medicine tablets
.
In July, the State Food and Drug Administration issued a notice on a drug that did not meet the regulations, and 19 batches of drugs produced by 16 enterprises did not meet the regulations, many of which were named for traditional Chinese medicine tablets, such as chrysanthemums, Sichuan beef knees, mugwort leaves, etc.
, which did not meet the characteristics, microscopic identification, leachings, and prohibited pesticide residues
.
In April, the Fujian Provincial Food and Drug Administration issued a notice that after supervising and sampling the quality of drugs used by some drug manufacturers and trading enterprises in the province, it was found that 4 batches of drugs did not meet the regulations, of which a drug from a Chinese medicine tablet company entered the "black list"
.
In addition to special rectification, the industry pointed out that the implementation of the Drug Administration Law and the new version of the Pharmacopoeia has put forward higher requirements for the tablet industry, and has increased the cost of violating the law for counterfeit drugs and inferior drugs, bringing huge deterrents to the industry
.
The new edition of the Pharmacopoeia Part IV 0212 General Rules for the Verification of Medicinal Materials and Drinking Tablets stipulates: Unless otherwise specified, the moisture of drinking tablets shall not exceed 13%; The chips and impurities shall not exceed 3%; The residual amount of sulfur dioxide in medicinal materials and tablets (except minerals) shall not exceed 150mg/kg; Banned pesticides (see the table below) of medicinal herbs and tablets (see the table below) shall not be detected (shall not exceed the quantitative limit).
Under the implementation of the new pharmacopoeia, the tablet industry needs to strengthen the testing of 33 kinds of pesticide residues to ensure that the product standards meet the regulations
.
According to the new version of the Drug Administration Law, those who produce or sell inferior drugs shall confiscate the drugs and illegal gains illegally produced or sold, and impose a fine of between 10 times and 20 times the value of the drugs illegally produced or sold; Where the value of drugs illegally produced or wholesaled is less than 100,000 yuan, it shall be calculated as 100,000 yuan, and where the value of drugs illegally retailed is less than 10,000 yuan, it shall be calculated as 10,000 yuan; Where the circumstances are serious, order the suspension of production and business for rectification until the drug approval documents, drug production licenses, drug business licenses, or medical institution preparation licenses are revoked
.
The industry believes that the Traditional Chinese medicine tablets industry is also supported by many favorable policies while facing strict supervision, and it is an "immunization" track for medical insurance, and the market size is huge
.
According to the "2020 China Pharmaceutical Industry Economic Operation Report", the market size of traditional Chinese medicine tablet processing in 2020 has reached 178.
2 billion yuan
.
With the continuous improvement of the pass rate of sampling inspection, it is expected that the entire market will also develop in the direction of
high quality and standardization.
