After the ginkgo leaf incident, it's the turn for Compound Danshen tablet to play?

Source: since the late May of dandelion 2015-6-9, CFDA has made great momentum and achieved some achievements in the special treatment actions of Ginkgo biloba extract and its preparations In this rectification action, some deliberately made and sold fake goods, and some were implicated in the case of ignorance In a word, the special action has a great impact on the whole field of traditional Chinese medicine production! The author believes that, as a drug regulatory department, we should draw lessons from the ginkgo leaf incident, draw inferences from one case and make a thorough governance of the traditional Chinese medicine preparation industry For example, "Compound Danshen Tablet" is a variety that needs to take decisive measures For a period of time, "Compound Danshen Tablet" has exposed many problems, but the attack is obviously not enough Some counterfeiters and sellers seem to be fighting with open fire As long as our regulatory department has a strong hand, it will get something For many years, the false cases of Compound Danshen Tablet adulteration disclosed by the media and professional journals are not uncommon On March 31 of this year, Guangdong food and Drug Administration released the results of drug quality spot check in the fourth quarter of 2014 Among the 13 batches of fake drugs confirmed, 6 batches were "Compound Danshen Tablet", which were all unqualified in the spot check of "Notoginsenoside" On June 1, Jiangsu food and Drug Administration released the "2014 4th pharmaceutical quality announcement" through its official website There are 46 batches of chemical drugs, biochemical drugs and Chinese patent medicine preparations that do not meet the requirements, including 7 batches of Compound Danshen tablets Batches, including Jilin Jianjin Pharmaceutical Co., Ltd., Inner Mongolia Renze Pharmaceutical Co., Ltd and Tonghua Changcheng Pharmaceutical Co., Ltd Among the 7 batches of Compound Danshen Tablets reported in Jiangsu Province, 5 of the unqualified items involved in the inspection of saponins from stem and leaf of Panax notoginseng, 1 batch was unqualified in the determination of tanshinone Ⅱ A and salvianolic acid B, and one batch was unqualified in the inspection of heterogenous organic substances In addition, two batches of heterogenous organic matter and Notoginsenoside were unqualified The inspection basis for Compound Danshen tablets is the first part of Chinese Pharmacopoeia 2010 edition and the supplementary inspection methods and approval documents for inspection items of the State Food and drug administration The determination method of tanshinone Ⅱ A and salvianolic acid B is stipulated in Chinese Pharmacopoeia It is no doubt that the quality of the unqualified batch is inferior The inspection items of heteroorganics and Notoginsenoside were carried out according to the supplementary inspection documents How to determine the quality of Compound Danshen Tablets and the unqualified batches of Compound Danshen tablets? According to the supplementary examination and approval document issued by the State Administration, under the microscope of 100 times, except for the plant tissues of the original Sanqi herbs, the other plant tissues in the prescription of Compound Danshen tablets are all heterosexual organics In the chromatography of compound salvia miltiorrhiza tablets, there should be no spots that are completely consistent with those of Notoginsenoside on crops, otherwise, it is judged as unqualified The "Drug Administration Law" clearly stipulates that a drug containing ingredients that do not conform to the ingredients specified in the national drug standards is a fake drug If the test items of Compound Danshen tablet are not qualified, it indicates that there are differences between its components and the national drug standard, so it should be judged as a fake drug according to law According to the provisions of the "Drug Administration Law", the drug approval certificate (drug approval document) of any fake drug shall be revoked according to law, i.e the drug approval number If the circumstances are serious, the drug production license shall be revoked according to law However, the enterprises suspected of producing fake Compound Danshen tablets have been exposed repeatedly, but they have never seen the information of the cancelled number Who should decide the administrative penalty of revoking the document number? This is a problem, in fact, it is not a problem!