[exclusive] number of unqualified Chinese herbal medicines in 2018

On August 31, the State Food and Drug Administration issued the work plan for the centralized treatment of the quality of Chinese herbal pieces, and decided to carry out a one-year nationwide centralized treatment of the quality of Chinese herbal pieces The treatment action of Chinese herbal pieces, which has only heard thunder but no rain, finally kicked off Chinese herbal pieces are an important part of traditional Chinese medicine Next, we will analyze the unqualified Chinese herbal medicines in 2018 to explore which varieties, enterprises and regions will be the focus of this nationwide remediation activity? 1 According to the statistics of six types of substandard drugs, since 2018 (as of September 6), there have been 2349 batches of substandard drugs, excluding 423 batches of counterfeit drugs, involving six types of traditional Chinese medicine, proprietary Chinese medicine, chemical drugs, drug packaging materials, auxiliary materials and others Unqualified drugs are mainly concentrated in traditional Chinese medicine, Chinese patent medicine and chemical medicine Among them, 1714 batches were unqualified, accounting for 73%; 455 batches were unqualified, accounting for 19%; 167 batches were unqualified, accounting for 7% The proportion of Chinese herbal medicines is the highest among the types of unqualified drugs, and the proportion is on the rise compared with 64% in 2017 (Note: other items in the figure include 9 drug packaging materials, 1 auxiliary material and 3 other categories) 2 Top 10 of the unqualified traditional Chinese medicine varieties shows that top 3 of the unqualified drugs in 2017 are also traditional Chinese medicine, including safflower, alum and earthworm, according to the analysis report on the unqualified data of 2017 released by www.yaozhi.com at the beginning of the year And this time, earthworm was also on the list, and ranked first Among the 1714 batches of substandard Chinese herbal medicines, the top 10 medicines are Atractylodes, earthworm, liquorice, myrrh, fresh white skin, Peucedanum, cortex rehmanniae, Typhae, Pueraria, chrysanthemum indicum and yam Among them, Atractylodes macrocephala has the most, 98 (calculated by unqualified batches, the same below); earthworm ranks second, 65; liquorice and myrrh have 56 respectively, tied for the third (see Figure 1 for details: unqualified Chinese herbal medicine TOP10) Figure 1 3 top 10 enterprises with unqualified quality of traditional Chinese Medicine Based on the statistics of batches and quantities of substandard Chinese herbal medicines, it is found that there are eight top 10 enterprises of substandard Chinese herbal medicines, among which Jiangxi Zhaosheng, Jiangxi kangqingtang and Bozhou Yonggang are the top three (see Figure 2 for details: Top 10 enterprises of substandard Chinese herbal medicines) Among them, Bozhou Yonggang Yinpian Factory Co., Ltd also appeared in the top 20 drug quality unqualified enterprises counted in the 2017 drug quality unqualified data analysis report In addition, Zhangshu Qingren Herbal Pieces Co., Ltd and Bozhou Haomen Herbal Pieces Co., Ltd in top 10 ranked second and third respectively in top 20 in 2017 Figure 24 top 10 unqualified Chinese herbal medicines in the provinces with unqualified quality are almost all over the country, among which Gansu, Jiangxi, Shandong, Hubei and Shanghai have detected a large number of unqualified Chinese herbal medicines, and the number of unqualified Chinese herbal medicines is more than 100 batches (see Figure 3 for details: Top 10 of the provinces with unqualified Chinese herbal medicines) In addition, 58 batches of Chinese herbal medicines were found unqualified by the general administration It is worth mentioning that more than 200 batches of substandard drugs were detected in Guangdong, Inner Mongolia, Fujian and Jiangsu provinces last year In addition, Inner Mongolia, Fujian and Jiangsu mainly focus on traditional Chinese medicine However, no substandard batches were found in Inner Mongolia this time, and the latter two provinces also significantly reduced, which is a good phenomenon Figure 3 5 Analysis of counterfeit drugs in 423 batches of counterfeit drugs, excluding 5 batches of Chinese patent drugs and 6 batches of chemical drugs, the remaining 412 batches are all Chinese medicinal materials Among them, Anhui Mengshi Herbal Pieces Co., Ltd., Anhui yaozhiyuan Herbal Pieces Co., Ltd., Bozhou Herbal Pieces Factory, Bozhou Haomen Herbal Pieces Co., Ltd., Anhui Youxin Pharmaceutical Co., Ltd and other enterprises have been counterfeited by illegal elements, which is more prominent (see Figure 4 for details: quantity of counterfeited Chinese herbal medicines) Figure 4 summarizes the statistical data and finds that the quality problems of traditional Chinese medicine are still very prominent The number of unqualified drugs accounts for 73% of the total number of unqualified drugs, with an upward trend compared with the proportion in 2017 And in the unqualified enterprises, Chinese herbal medicine enterprises still occupy the majority, some of which are listed repeatedly This also shows that the state should strengthen the supervision of the quality of medicinal materials, at the same time, it should also establish the inspection of key enterprises However, with the strengthening of drug supervision in various provinces, we have seen some results For example, Inner Mongolia, Fujian and Jiangsu, which were more listed as unqualified batches of traditional Chinese medicine by random inspection last year, have been improved Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; 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