echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > 57 batches of drugs are found to be unqualified! 40 enterprises involved

    57 batches of drugs are found to be unqualified! 40 enterprises involved

    • Last Update: 2019-11-27
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    [industry trends of pharmaceutical network] recently, the State Food and Drug Administration issued a circular on 57 batches of drugs that did not meet the requirements According to the notice, 57 batches of drugs produced by 40 enterprises failed to meet the requirements after inspection by 11 drug inspection institutions such as Suzhou drug inspection and Research Center, among which at least 10 were Chinese Herbal Pieces enterprises At present, the pharmaceutical supervision and administration department has required relevant enterprises and units to take risk control measures such as suspension of sales and use, recall, etc., to investigate the causes of non-compliance and carry out effective rectification According to the list of 57 batches of non-conforming drugs, including piperazine ferulate tablets (50mg), calcium gluconate oral solution (10%), acetylcysteine solution for inhalation (3ml: 0.3g), eperisone hydrochloride tablets (50mg), etc The non-conforming items include properties, related substances, content determination, water content, extract, etc For non-conforming projects, the circular also popularized small knowledge For example, appearance, odor, taste, solubility and physical constants are generally recorded under the property item, which reflect the quality characteristics of drugs to a certain extent It is possible that the characters of Chinese herbal pieces do not meet the requirements due to the deviation of species, the defect of processing technology and improper storage Related substances refer to the organic impurities in drugs, which reflect the purity of drugs The main sources are impurities brought in during the preparation process and impurities produced by degradation of drugs in storage or transportation Content determination refers to the determination of the content of the effective ingredients in raw materials and preparations by the specified test method, which can generally be determined by chemical, instrumental or biological methods The assay was related to the efficacy of the drug Water content refers to the water content of drugs If the moisture content in traditional Chinese medicine is too high, it is usually related to factors such as technology, improper packaging and storage and transportation environment The extractive items in the standards of traditional Chinese medicine and decoction pieces can reflect the content of the internal components of traditional Chinese medicine and decoction pieces Nonstandard production place, growth period, harvest season, processing method, processing technology and other links of Chinese herbal medicine and decoction pieces may lead to the content of the extract not meeting the requirements The market prospect of Chinese herbal pieces is considerable, but its quality has been concerned by the industry From the knowledge listed above, it can be seen that the quality control of Chinese herbal pieces is not easy From the source and growth of decoction pieces to the collection, processing, processing, packaging, transportation, storage environment, any link is not standardized or improper, it is easy to cause problems in products Under the background of more and more strict supervision of the beverage industry, the beverage enterprises are also facing greater pressure In recent years, there has been a lot of news about the disqualified pieces being stopped and recalled For example, a total of 38 batches of drugs were found to be unqualified in Hubei Province, including 32 batches of Chinese herbal pieces; 269 batches of drugs were found to be unqualified in Jiangxi Province, including 167 batches of Chinese herbal pieces; Chongqing and Heilongjiang drug regulatory bureaus issued drug quality announcements, and Chongqing investigated 45 batches of unqualified drugs, all of which were Chinese herbal medicines and their pieces, and 11 batches of drugs in Heilongjiang Province were also qualified Chinese herbal medicine and its pieces In addition, Fujian, Jiangxi, Shandong, Hunan, Shanxi and other provinces and cities have also issued drug quality announcements, which also involves a large number of substandard Chinese herbal medicines and their pieces It can be seen that the quality problems of traditional Chinese medicine and its pieces are still the hard injury of industrial development As the basis of ensuring the healthy development of traditional Chinese medicine clinical medicine and traditional Chinese medicine industry, traditional Chinese medicine enterprises must standardize production and strengthen quality management In terms of policy, the Pharmacopoeia of 2020 edition has new regulations on Chinese herbal pieces Among them, emphasis should be placed on "improving and standardizing the processing methods of Chinese Herbal Pieces" The industry believes that this measure is conducive to further curbing the disorder of Chinese herbal pieces, and Chinese Herbal Pieces enterprises are more confident to face the future market.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.