19 batches of drugs were unqualified, and Chinese medicine pieces were "named" again!

On November 15, the State Food and Drug Administration issued a notice on 19 batches of drugs that did not meet the regulations, and after inspection, 19 batches of drugs such as elderberry pills produced by 12 enterprises did not meet the regulations
.
Judging from the list of 19 batches of non-compliant drugs in the annex, the varieties that do not meet the regulations include vitamin U belladonna aluminum capsule II.
, elderberry pills, honeysuckle, peach kernels, etc.
, and the non-compliant items involve [content determination], [inspection] (heavy metals and harmful elements, moisture), [traits], carbonyl values, etc
.
For the above-mentioned non-compliant drugs, the drug regulatory authorities have required relevant enterprises to take risk control measures such as suspension of sales and use, recall, etc.
, to investigate the reasons for non-compliance and effectively carry out rectification
.
Chinese medicine pieces are a pillar industry in China's traditional Chinese medicine industry, and the market scale is huge
.
According to the data of the "2020 China Pharmaceutical Industry Economic Operation Report", the processing market size of traditional Chinese medicine pieces has reached 178.
2 billion yuan in 2020.

In the past, due to the backward standards of some medicinal materials, unscientific cultivation of traditional Chinese medicines, many small workshops with low prices and low quality, and inaccurate regulatory means, chaos in the traditional Chinese medicine tablet industry was frequent, and it was urgent to accelerate the standardization and centralized development
.
In recent years, many departments in China have jointly issued documents such as "National Construction Plan for Local Medicinal Materials Production Base" and "Quality Management Standards for the Production of Chinese Medicinal Materials" to jointly strengthen source management
.
And successively introduced a series of policies, rectified the chaos in the drinking pieces industry, and increased the punishment and cost
of illegal production enterprises.
The new version of the Drug Administration Law stipulates that those who produce or sell inferior drugs shall confiscate the drugs illegally produced and sold and the illegal gains, and impose a fine of not less than 10 times but not more than 20 times the value of the drugs illegally produced and sold; Where the value of illegally produced or wholesale drugs is less than 100,000 yuan, it shall be calculated as 100,000 yuan, and if the value of illegally retailed drugs is less than 10,000 yuan, it shall be calculated as 10,000 yuan; where the circumstances are serious, it shall be ordered to suspend production and business for rectification until the drug approval certificate, drug production license, drug trading license or preparation license
of medical institutions are revoked.
The new edition of the pharmacopoeia Part IV 0212 stipulates that unless otherwise specified, the moisture of drinking tablets shall not exceed 13%; Powder chips and impurities should usually not exceed 3%; The residual amount of sulfur dioxide in medicinal materials and pieces (except minerals) shall not exceed 150mg/kg; Pesticides prohibited in medicinal materials and pieces (plants) (see the table below for details) shall not be detected (shall not exceed the quantitative limit).

Under the implementation of the new pharmacopoeia, the Chinese medicine tablet industry needs to cope with the challenge
of pesticide residue detection.
With the implementation of the new regulations of the New Deal, the quality of Chinese medicine pieces has been significantly improved
.
According to the "2021 National Blue Book of Traditional Chinese Medicine Supervision", in recent years, the control of raw materials, the production process and the quality of quality of Chinese herbal pieces have been greatly improved and improved, and from 2016 to 2021, the overall qualification rate of Chinese medicine pieces has increased from 77.
7% to 98.
4%.

For the reasons for the current unqualified pieces of products, the industry believes that it may be related
to factors such as the small scale of the pieces and weak comprehensive competitiveness, the fact that some pieces companies do not have the testing conditions, and the testing links may be reduced in order to reduce costs, or the planting of Chinese medicinal materials is not scientific, resulting in pesticide residues and heavy metals exceeding the standard, and it is difficult to meet the pharmacopoeia standards.
Drugs are special commodities, for pharmaceutical companies, safety should be the bottom line, quality as the red line, the production of conscientious medicine, reassuring medicine, do not be limited to short-term interests for a while, because the small loses the big
.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.