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[Pharmaceutical Network Industry News] Chinese herbal decoction pieces are one of the three pillars of China's traditional Chinese medicine industry.
Driven by an aging population and favorable policies, Chinese herbal decoction pieces have broad market prospects in the future
.
However, for a long time, illegal processing, counterfeiting, selling of counterfeit and other illegal activities have been common in the Chinese herbal medicine industry, which has seriously hindered the pace of high-quality development of the industry
.
In recent years, with the implementation of the new version of the Pharmacopoeia, the new version of the Drug Administration Law, and the intensification of sampling inspections by relevant departments, the market for Chinese herbal medicines has been reshuffled at an accelerated pace, and companies have paid more and more attention to compliance operations
.
Recently, the China National Institute for Food and Drug Control released the National Drug Sampling Annual Report (2021).
The sampling results show that the current drug safety situation in China is generally stable and controllable, and drug quality continues to maintain a high level
.
Among them, TCM decoction pieces are also the object of sampling inspection by the hospital.
In 2021, a total of 1957 batches of special sampling inspection tasks for 9 TCM decoction pieces will be completed, mainly focusing on the safety aspects of TCM decoction pieces (such as adulteration, illegal dyeing), and quality control.
(such as production standardization, specificity, sulfur dioxide, heavy metals and pesticide residues) and other aspects to carry out inspection and exploratory research
.
Judging from the sampling results, the overall compliance rate of TCM decoction pieces in 2021 is high, with 1,925 batches that meet the regulations, and only 32 batches that do not meet the regulations
.
Judging from these 32 batches of non-compliant items, they mainly involve total ash content, characters, impurities, identification and content determination
.
Among them, the non-compliant items of traits and impurities accounted for a high proportion, accounting for 51.
4% and 31.
4% of all non-compliant items respectively
.
In addition, the main problems found in the special sampling inspection of Chinese herbal medicines include: the substitution and doping of counterfeit products; the problem of excessive residues of exogenous harmful substances; the problem of irregular harvesting and processing
.
Medicines are special commodities, and the quality and safety issues should not be underestimated, especially for counterfeit and inferior medicines, and our country's laws are even more tolerant
.
According to the new version of the "Drug Administration Law", the scope of counterfeit drugs includes: the ingredients contained in the drugs do not conform to the ingredients specified in the national drug standards; non-drugs pass off as drugs or other drugs pass off as such drugs; spoiled drugs; Indications or functional indications are beyond the specified range
.
The scope of inferior drugs includes: the content of drug ingredients does not meet the national drug standards; contaminated drugs; drugs that do not indicate or change the expiry date; drugs that do not indicate or change the product batch number; drugs that exceed the expiry date; drugs; other drugs that do not meet the drug standards
.
At present, there have been a large number of cases in which pharmaceutical companies have been fined huge sums of money for producing and selling counterfeit and inferior medicines.
Among them, there are many Chinese medicine decoction pieces companies.
The items that do not meet the regulations and the problems found during the random inspection in 2021 will be heard again.
A wake-up call for the industry
.
According to the industry, the high-quality development of Chinese herbal decoction pieces has become the general trend
.
Under the background of increasingly strict industry supervision and ever-increasing violations, TCM decoction pieces enterprises can no longer treat with luck, they should strictly adhere to product quality and safety, and attach great importance to the control of quality and safety at the source of TCM planting.
, Scientific management, processing and storage, while strengthening the traceability of medicinal materials, continuously improving the quality management awareness of traditional Chinese medicine enterprises, and ensuring the quality and safety of medicinal materials
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
Driven by an aging population and favorable policies, Chinese herbal decoction pieces have broad market prospects in the future
.
However, for a long time, illegal processing, counterfeiting, selling of counterfeit and other illegal activities have been common in the Chinese herbal medicine industry, which has seriously hindered the pace of high-quality development of the industry
.
In recent years, with the implementation of the new version of the Pharmacopoeia, the new version of the Drug Administration Law, and the intensification of sampling inspections by relevant departments, the market for Chinese herbal medicines has been reshuffled at an accelerated pace, and companies have paid more and more attention to compliance operations
.
Recently, the China National Institute for Food and Drug Control released the National Drug Sampling Annual Report (2021).
The sampling results show that the current drug safety situation in China is generally stable and controllable, and drug quality continues to maintain a high level
.
Among them, TCM decoction pieces are also the object of sampling inspection by the hospital.
In 2021, a total of 1957 batches of special sampling inspection tasks for 9 TCM decoction pieces will be completed, mainly focusing on the safety aspects of TCM decoction pieces (such as adulteration, illegal dyeing), and quality control.
(such as production standardization, specificity, sulfur dioxide, heavy metals and pesticide residues) and other aspects to carry out inspection and exploratory research
.
Judging from the sampling results, the overall compliance rate of TCM decoction pieces in 2021 is high, with 1,925 batches that meet the regulations, and only 32 batches that do not meet the regulations
.
Judging from these 32 batches of non-compliant items, they mainly involve total ash content, characters, impurities, identification and content determination
.
Among them, the non-compliant items of traits and impurities accounted for a high proportion, accounting for 51.
4% and 31.
4% of all non-compliant items respectively
.
In addition, the main problems found in the special sampling inspection of Chinese herbal medicines include: the substitution and doping of counterfeit products; the problem of excessive residues of exogenous harmful substances; the problem of irregular harvesting and processing
.
Medicines are special commodities, and the quality and safety issues should not be underestimated, especially for counterfeit and inferior medicines, and our country's laws are even more tolerant
.
According to the new version of the "Drug Administration Law", the scope of counterfeit drugs includes: the ingredients contained in the drugs do not conform to the ingredients specified in the national drug standards; non-drugs pass off as drugs or other drugs pass off as such drugs; spoiled drugs; Indications or functional indications are beyond the specified range
.
The scope of inferior drugs includes: the content of drug ingredients does not meet the national drug standards; contaminated drugs; drugs that do not indicate or change the expiry date; drugs that do not indicate or change the product batch number; drugs that exceed the expiry date; drugs; other drugs that do not meet the drug standards
.
At present, there have been a large number of cases in which pharmaceutical companies have been fined huge sums of money for producing and selling counterfeit and inferior medicines.
Among them, there are many Chinese medicine decoction pieces companies.
The items that do not meet the regulations and the problems found during the random inspection in 2021 will be heard again.
A wake-up call for the industry
.
According to the industry, the high-quality development of Chinese herbal decoction pieces has become the general trend
.
Under the background of increasingly strict industry supervision and ever-increasing violations, TCM decoction pieces enterprises can no longer treat with luck, they should strictly adhere to product quality and safety, and attach great importance to the control of quality and safety at the source of TCM planting.
, Scientific management, processing and storage, while strengthening the traceability of medicinal materials, continuously improving the quality management awareness of traditional Chinese medicine enterprises, and ensuring the quality and safety of medicinal materials
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
