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On October 29, the Yunnan Provincial Food and Drug Administration issued the 2021 Phase 3 Drug Quality Announcement
.
According to the announcement, in order to strengthen drug quality supervision and ensure the safety of drug use by the public, in accordance with the Yunnan Provincial Drug Supervision and Sampling Inspection Plan in 2021, the drug supervision and administration departments at all levels in the province have carried out random inspections on the drug quality of the drug production and operation enterprises and users in the province.
, Now the situation of drug sampling inspection is announced
.
According to statistics, 21 batches of medicines from 13 drug manufacturers were found to be unqualified this time, involving 3 unqualified Chinese patent medicines, namely Dragon Blood Capsules, Banlangen Granules, and Ganoderma Tonic Pills.
The other 18 batches were all Chinese medicines.
Decoction pieces, including atractylodes, acanthopanax, Baiji, Poria cocos, Epimedium, vinegar tortoise shell, dandelion, licorice (licorice slices), earthworm, vinegar and myrrh, hawthorn powder, black snake, curculio, and Amomum villosum
.
From the point of view of unqualified items, the main ones are [Properties], [Inspection], [Assay] and so on
.
Judging from the inspection results, decoction pieces of traditional Chinese medicine accounted for the majority of substandard drugs
.
In recent years, the traditional Chinese medicine decoction piece industry has developed rapidly, but the problems related to processing, counterfeiting, sales of counterfeit products, and irregular processing are quite serious in the market, and its quality and safety have always been highly valued by the drug regulatory authorities
.
It is understood that in February 2020, the State Food and Drug Administration issued the "Work Plan for Special Remediation of Chinese Herbal Medicine Pieces", which puts forward the overall goals and main work points for the national special rectification of Chinese medicine pieces
.
Subsequently, in May of the same year, the State Food and Drug Administration held a video and telephone conference, requesting drug regulatory authorities at all levels to implement territorial regulatory responsibilities in accordance with the "four strictest" requirements, carefully inspect the production and operation units of traditional Chinese medicine decoction pieces and preparations, and resolutely investigate and punish violations of the law.
Violation of regulations; all units producing and operating Chinese herbal medicines and preparations, as well as the Chinese herbal medicine market, must implement their main responsibilities, and conduct comprehensive self-examination and rectification in accordance with the newly revised "Drug Administration Law", drug production quality management practices, and drug business quality management practices, and clear the source Guyou, and continuously improve the quality of Chinese herbal medicine
.
The implementation of the new version of the Pharmacopoeia on December 30, 2020 puts forward strict management requirements for the production and other aspects of the traditional Chinese medicine decoction industry..
For example, the new edition of Pharmacopoeia Part IV 0212 General Rules for the Verification of Medicinal Materials and Decoction Pieces stipulates: Unless otherwise specified, the moisture content of decoction pieces shall usually not exceed 13%; medicinal scraps and impurities shall usually not exceed 3%; the residual sulfur dioxide of medicinal materials and decoction pieces (except minerals) No more than 150mg/kg; forbidden pesticides for medicinal materials and decoction pieces (plants) (see the table below for details) shall not be detected (not exceed the limit of quantification)
.
The regulations also mean 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 enterprises
.
In addition, the new edition of the Pharmacopoeia has comprehensively formulated the limit standards for mycotoxins that are prone to moldy Chinese medicinal materials and decoction pieces
.
The specific varieties increased to 24: Aflatoxins: (24) Nine-sweet insect, soil beetle, jujube, horse money, leech, earth dragon, nutmeg, corydalis, whole scorpion, cassia, malt, polygala, dried tangerine peel, Make gentleman, cypress seed, fat sea, lotus seed, peach kernel, centipede, hive, betel nut, wild jujube kernel, silkworm, coix seed
.
Zearalenone: (1) Coix seed
.
In general, the life of the decoction piece industry will become more and more challenging
.
In this context, Chinese medicine decoction pieces enterprises need to strictly control all aspects, improve the quality of Chinese medicine, and regulate their operations, otherwise they will face high illegal costs and even be eliminated
.
.
According to the announcement, in order to strengthen drug quality supervision and ensure the safety of drug use by the public, in accordance with the Yunnan Provincial Drug Supervision and Sampling Inspection Plan in 2021, the drug supervision and administration departments at all levels in the province have carried out random inspections on the drug quality of the drug production and operation enterprises and users in the province.
, Now the situation of drug sampling inspection is announced
.
According to statistics, 21 batches of medicines from 13 drug manufacturers were found to be unqualified this time, involving 3 unqualified Chinese patent medicines, namely Dragon Blood Capsules, Banlangen Granules, and Ganoderma Tonic Pills.
The other 18 batches were all Chinese medicines.
Decoction pieces, including atractylodes, acanthopanax, Baiji, Poria cocos, Epimedium, vinegar tortoise shell, dandelion, licorice (licorice slices), earthworm, vinegar and myrrh, hawthorn powder, black snake, curculio, and Amomum villosum
.
From the point of view of unqualified items, the main ones are [Properties], [Inspection], [Assay] and so on
.
Judging from the inspection results, decoction pieces of traditional Chinese medicine accounted for the majority of substandard drugs
.
In recent years, the traditional Chinese medicine decoction piece industry has developed rapidly, but the problems related to processing, counterfeiting, sales of counterfeit products, and irregular processing are quite serious in the market, and its quality and safety have always been highly valued by the drug regulatory authorities
.
It is understood that in February 2020, the State Food and Drug Administration issued the "Work Plan for Special Remediation of Chinese Herbal Medicine Pieces", which puts forward the overall goals and main work points for the national special rectification of Chinese medicine pieces
.
Subsequently, in May of the same year, the State Food and Drug Administration held a video and telephone conference, requesting drug regulatory authorities at all levels to implement territorial regulatory responsibilities in accordance with the "four strictest" requirements, carefully inspect the production and operation units of traditional Chinese medicine decoction pieces and preparations, and resolutely investigate and punish violations of the law.
Violation of regulations; all units producing and operating Chinese herbal medicines and preparations, as well as the Chinese herbal medicine market, must implement their main responsibilities, and conduct comprehensive self-examination and rectification in accordance with the newly revised "Drug Administration Law", drug production quality management practices, and drug business quality management practices, and clear the source Guyou, and continuously improve the quality of Chinese herbal medicine
.
The implementation of the new version of the Pharmacopoeia on December 30, 2020 puts forward strict management requirements for the production and other aspects of the traditional Chinese medicine decoction industry..
For example, the new edition of Pharmacopoeia Part IV 0212 General Rules for the Verification of Medicinal Materials and Decoction Pieces stipulates: Unless otherwise specified, the moisture content of decoction pieces shall usually not exceed 13%; medicinal scraps and impurities shall usually not exceed 3%; the residual sulfur dioxide of medicinal materials and decoction pieces (except minerals) No more than 150mg/kg; forbidden pesticides for medicinal materials and decoction pieces (plants) (see the table below for details) shall not be detected (not exceed the limit of quantification)
.
The regulations also mean 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 enterprises
.
In addition, the new edition of the Pharmacopoeia has comprehensively formulated the limit standards for mycotoxins that are prone to moldy Chinese medicinal materials and decoction pieces
.
The specific varieties increased to 24: Aflatoxins: (24) Nine-sweet insect, soil beetle, jujube, horse money, leech, earth dragon, nutmeg, corydalis, whole scorpion, cassia, malt, polygala, dried tangerine peel, Make gentleman, cypress seed, fat sea, lotus seed, peach kernel, centipede, hive, betel nut, wild jujube kernel, silkworm, coix seed
.
Zearalenone: (1) Coix seed
.
In general, the life of the decoction piece industry will become more and more challenging
.
In this context, Chinese medicine decoction pieces enterprises need to strictly control all aspects, improve the quality of Chinese medicine, and regulate their operations, otherwise they will face high illegal costs and even be eliminated
.
