Document issued by the drug administration: strictly inspect the traditional Chinese medicine and its pieces

4106 batches of drugs were seized, most of which were Chinese medicinal materials and their pieces Traditional Chinese medicine, its pieces and proprietary Chinese medicine have become the focus of remediation in 2018 The proportion of substandard traditional Chinese medicine and proprietary Chinese medicine is 86% Recently, yaozhi.com released the "2017 annual analysis report on unqualified drug quality data" According to the data, 4106 batches of substandard drugs and 654 batches of counterfeit products were seized in 2017 It is understood that the unqualified drugs involved in this analysis report are divided into seven types: Chinese herbal medicine (medicinal materials and their pieces), Chinese patent medicine, chemical medicine, biological medicine, drug packaging materials, auxiliary materials and other seven types Among them, there are 2618 batches of unqualified Chinese herbal medicines, accounting for 64%; 917 batches of unqualified Chinese patent medicines, accounting for 22%; the total proportion of Chinese herbal medicines and Chinese patent medicines reaches 86% Among the unqualified varieties of traditional Chinese medicine, safflower has the largest number, 113 (calculated by unqualified batches, the same below); alum ranks second, 86; earthworm 85, ranks third In addition, 2017 new herbal medicines include alum, woodlouse worms, Amomum villosum, ginseng, Pueraria lobata, cereal extract, dangshen, borneol, Rhizoma Bletillae, chrysanthemum, Ge Gen, cortex Morgan, vinegar, myrrh, etc As for the causes of nonconformity, including the differences in properties, content determination, ash content, identification, related substances, water content, sulfur dioxide residue, loading difference, heavy metals, leachables, etc In addition, the most prominent problem was character examination, accounting for 35% The General Administration of food and medicine and the administration of traditional Chinese medicine have said frankly that they need to rectify It is understood that Chinese herbal medicine and its pieces have developed rapidly in the past two years under the encouragement of policies, but they have also laid a curse and the quality problems have been increasing year by year In response to this outstanding problem, the directors of the General Administration of food and medicine and the administration of traditional Chinese medicine all admitted that efforts should be intensified in 2018 At the end of January 2018, Bi Jingquan, director of CFDA, put forward at the national food and Drug Administration and the party's work conference on building a clean and honest government that the special remediation of the pharmaceutical industry will become one of the priorities of CFDA in 2018, and the six categories of Chinese herbal pieces, injections, multi-component biochemical preparations, Chinese herbal extracts, clinical data verification, cosmetics, etc will be the focus of inspection In addition, it is suggested that the quality of Chinese herbal pieces should be traced back to the source All pieces that fail to pass the inspection must be traced back to the end until the source of production At the same time, Wang Guoqiang, director of the State Administration of traditional Chinese medicine, once said frankly, "some people say that traditional Chinese medicine may be destroyed in traditional Chinese medicine, which is not alarmist What I am worried about is that the best doctor, even the master of Chinese medicine, can't grasp the medicine you prescribe If the people eat it and have no effect, it will destroy the traditional Chinese medicine " Before this year's two sessions, Wang Guoqiang responded that in order to provide better services in traditional Chinese medicine, we should first solve the existing problems and then solve the problems So it seems that in 2018, the regulatory focus is on traditional Chinese medicine and herbal pieces It has been until yesterday that the crisis was rectified Article 7 of "key points of drug and cosmetics supervision in 2018" issued by Hubei Provincial Food and drug administration points out that "special inspection on outstanding problems" should be carried out, focusing on cracking down on illegal behaviors of "potential rules" such as dyeing and weight gain, adulteration and counterfeiting, and OEM and sales of purchased beverage pieces Special inspection shall be carried out for injection, focusing on the source of raw materials or medicinal materials, process stability, control of key links, sterility guarantee level, and differences between batches Consolidate the existing achievements, and continue to grasp the key issues such as multi-component biochemical drugs and the legal sources of Chinese herbal extracts It can be seen that the treatment of traditional Chinese medicine and its pieces is on the way Secondly, traditional Chinese medicine and its pieces will also be the key to the illegal operation of pharmacies At the end of June 2017, the General Administration of food and drug listed "the sale of Chinese herbal medicines and primary processed products as Chinese herbal pieces, and the illegal processing of Chinese Herbal Pieces" as the top ten priorities Only by strengthening the quality can there be a future The industry insiders say that more and more quality exposure shows that the country pays more and more attention to traditional Chinese medicine, so that traditional Chinese medicine will not be destroyed by traditional Chinese medicine The healthy development of Chinese herbal pieces can not rely on increasing supervision and punishment, but on the recognition and self-discipline of enterprises on quality The enterprise that pursues quality must be the "leftover" who can stand the gallop test! Therefore, only by strengthening the management, construction and management of the quality of traditional Chinese medicine and its pieces can enterprises have a future.