A batch of drugs did not meet the regulations and was fined 330,000 yuan!

Recently, the Anhui Provincial Food and Drug Administration released two pieces of information on administrative penalties for a Chinese herbal medicine company
.
The company's batch of drugs failed to meet the regulations after inspection, and a total of 330,000 yuan was fined
.
One of the penalty decisions showed that the company's honey coltsfoot [inspection] impurities did not meet the requirements (standard: should not exceed 3%, inspection result: 32%)
.
According to relevant laws and regulations, 11kg of unqualified honey sweet winter flowers were confiscated; 322.
00 yuan of illegal income was confiscated; 2.
A fine of 250,000 yuan, 2.
5 times the value of illegally produced and sold drugs, was imposed;
.
Another document shows that the above company's puffball inspection results: [inspection] total ash (standard: should not exceed 15.
0%, inspection result: 36.
5%), acid-insoluble ash (standard: should not exceed 10.
0%, inspection Results: 29.
6%) items did not meet the requirements
.
According to relevant laws and regulations, the company was confiscated 378.
00 yuan of illegal income; a fine of 1134.
00 yuan was imposed on three times the value of illegal production and sales of drugs; a fine of 80,000 yuan for lending the "Drug License"; a total of 81,100 yuan in fines and confiscated; confiscated Suspended sales of Chinese herbal decoction pieces Puffball 1kg
.
To sum up, the two products of the company were fined 330,000 yuan in total because they failed the inspection
.
For most enterprises, this fine is not a small amount.
It can be seen that the strict supervision of the industry and the severe punishment will bring deterrence to enterprises in the whole decoction piece industry
.
Not long ago, a batch of Chinese herbal decoction pieces in Jiangxi Province was detected to be non-compliant, involving many varieties of Chinese herbal medicines such as vinegar turtle, Acanthopanax senticosus, and vinegar Yanhusuo
.
From the perspective of unqualified items, the main ones are [drug scraps impurities], [content determination], [aflatoxin] and so on
.
The Provincial Food and Drug Administration has instructed relevant departments to take necessary control measures such as sealing up, detaining, suspending sales, and recalling drugs that do not meet the regulations, and investigate and punish the production enterprises and sampled units in accordance with relevant laws and regulations
.
In recent years, China's traditional Chinese medicine decoction pieces industry has developed very rapidly.
In order to ensure the quality of the decoction pieces, the supervision of the relevant departments has been continuously increased, which has led to the continuous improvement of the pass rate of the sampling inspection of Chinese medicine decoction pieces
.
However, due to the backward standards of some Chinese medicinal materials, unscientific cultivation of traditional Chinese medicine, many small workshops with low prices and low quality, and inaccurate supervision methods, there are still many problems in the market related to processing, counterfeiting, selling counterfeit, and irregular processing.
happen
.
To this end, new policies and new regulations for the decoction piece industry are also continuously being introduced.
For example, the new version of the Pharmacopoeia has put forward strict management requirements for the production of the Chinese medicine decoction piece industry
.
Among them, the new edition of Pharmacopoeia Part 4 0212 General Rules for the Verification of Medicinal Materials and Decoction Pieces stipulates: unless otherwise specified, the moisture content of decoction pieces should not exceed 13%; drug chips and impurities usually should not exceed 3%; the sulfur dioxide residues of medicinal materials and decoction pieces (except minerals) It should not exceed 150mg/kg; the banned pesticides (see the table below) for medicinal materials and decoction pieces (plants) should not be detected (the limit of quantification should not be exceeded)
.
This regulation also means that all plant-based Chinese medicinal materials and decoction pieces need to be tested for 33 pesticide residues
.
Pesticide residues will become a major difficulty for Chinese herbal medicine companies
.
In addition, the new version of the Pharmacopoeia has comprehensively formulated the limit standards for mycotoxins in Chinese herbal medicines and decoction pieces that are prone to mildew
.
The number of specific varieties has been increased to 24: Aflatoxins: (24) nine incense insects, soil soft-shelled turtles, jujubes, strychnids, leeches, earthworms, nutmeg, Corydalis, whole scorpions, cassia seeds, malt, polygala, tangerine peel, Make gentlemen, cypress kernels, fat sea, lotus seeds, peach kernels, centipedes, beehives, betel nut, sour jujube kernels, stiff silkworms, and coix seeds
.
Zearalenone: (1) Coix seed
.
In general, for decoction pieces enterprises, under the background of the implementation of the new version of the Drug Administration Law and the tightening of industry supervision, the production of substandard drugs will bear an incomparable price.
Management is already imminent
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.