Extract has become the weakness of traditional Chinese medicine industry

Chinese herbal extracts have become the "target" of regulatory authorities because they have seriously delayed the development of Chinese herbal medicine industry Yesterday, the State Food and Drug Administration issued a notice, requiring all relevant Chinese herbal extract production and use enterprises to carry out self inspection this month, and in September, the provincial food and Drug Administration stepped in to carry out special inspection, which means that the State Food and Drug Administration will fight hard to rectify the industry's "weakness" Extracts drag on the traditional Chinese medicine industry yesterday's announcement, the State Food and Drug Administration said that from the recent inspection situation, there are still some enterprises dare to commit crimes against the wind, in violation of the provisions of the production and purchase of traditional Chinese medicine extracts, bringing safety risks to the quality of Chinese patent medicine "In fact, traditional Chinese medicine extract is a commonplace topic, which is a major weakness of traditional Chinese medicine industry In addition to the previous wave of Ginkgo biloba extract, it is estimated that the special treatment will cover a wide range and last for a long time." An industry observer told reporters The relevant directors of the State Food and drug administration have previously publicly pointed out several crimes of Chinese herbal extracts dragging the "hind legs" of the Chinese herbal industry: some Chinese patent medicine enterprises do not have the ability to extract, and it is difficult to guarantee the quality of drugs produced by purchasing illegal extracts; the relevant management system is not perfect and there are many loopholes; the existing drug regulatory laws and regulations do not specify the regulatory attributes of Chinese herbal extracts, and the production of Chinese herbal extracts the use is not clear, and it is free from the drug quality supervision system Under such a strict "one size fits all" policy, a new wave of Ginkgo biloba extract has occurred In 2015, the State Food and Drug Administration issued the notice on illegal production and sale of Ginkgo biloba drugs by Guilin Xingda Pharmaceutical Co., Ltd and other enterprises It was found that 24 pharmaceutical enterprises had the problem of purchasing illegal Ginkgo biloba extract, and some enterprises had the behavior of changing process to illegally produce Ginkgo biloba extract Then the State Food and Drug Administration issued the investigation and handling results, which showed that 59 enterprises were punished according to law for producing fake drugs and substandard drugs, including 4 enterprises whose "drug production license" was revoked; 47 enterprises were fined and other administrative penalties, with a total amount of 103 million yuan of fines; 4 enterprises were shut down without drug production qualification However, there are still risks and violations Yesterday, the reporter combed out the four key inspection points of the latest notice of the State Food and Drug Administration: 1 Key inspection of Chinese herbal extract production enterprises: the record of extract production; Organize the production according to the GMP requirements; check whether there is the OEM production behavior of the purchased traditional Chinese medicine extracts; 2 Key inspection of the traditional Chinese medicine manufacturers: the use and filing of the extracts; the quality evaluation of the extracts and the audit of the suppliers; whether there is material balance in the production process; whether there is the use of illegal extracts; 3 Set up the extraction vehicles in common and in different places within the group The key inspection of pharmaceutical manufacturing enterprises among: the production and quality management of extracts; the adequacy of quality control measures in the storage, packaging, transportation and other aspects of extracts; 4 Whether the enterprises and varieties that have been put on record meet the requirements of this document, and whether the records that do not meet the requirements are handled.