11 Provincial Drug Administration issued documents to strictly inspect the management of Chinese Herbal Pieces

In the second half of May, a large number of pharmacies had problems in the quality of Chinese herbal pieces and purchase channels The drug administration of 11 provinces issued a document to strictly check the adulterated and illegal purchase channels If problems were found, they should be traced back to the source and checked to the end Recently, Jiangxi Provincial Food and Drug Administration issued the plan of action for the special treatment of Chinese herbal medicine in the circulation field of Jiangxi Province, which decided to carry out the special treatment of Chinese herbal medicine in the circulation field from May 20 to October 20, and to focus on the inspection of wholesale and retail enterprises of Chinese herbal medicine In addition to Jiangxi, Hebei, Shandong, Jilin, Anhui, Hubei, Sichuan, Zhejiang, Gansu, Hainan, Shaanxi and other 10 provinces have all expressed their opinions one after another, and strictly inspect and punish the illegal business of decoction pieces On May 10, according to the information from the former State Food and drug administration, the drug administrations of Hebei and Shandong Province made a statement to strictly inspect the channels of drug purchase and illegal business of decoction pieces Hebei Provincial Food and Drug Administration issued the notice on centralized rectification of illegal business activities in the field of drug circulation, and decided to continue to carry out special rectification actions for illegal business activities in the field of drug circulation throughout the province from May 2 to the end of September, and severely crack down on illegal business activities in the process of drug wholesale and retail, mainly focusing on drug wholesale, urban-rural joint Department and drugstores in rural areas Three kinds of enterprises, such as the management of Chinese herbal pieces, carry out strict inspection Once any illegal act is found, it will be severely punished, and it will not be tolerated Shandong food and Drug Administration stated that it is necessary to carry out a special inspection campaign to severely crack down on the purchase of drugs from illegal channels in the field of drug circulation in the whole province, focusing on drug retail chain stores, single drugstores and clinics, especially those in the urban-rural fringe, rural and remote areas If it is found that drugs are purchased from illegal channels, the source shall be thoroughly investigated, the drugs involved in the case shall be recovered, the responsibility shall be severely investigated, and the punishment shall be severe and severe according to law, even the drug trading license shall be revoked On the same day, Changchun food and Drug Administration of Jilin City deployed the drug sampling work in 2018, mainly focusing on the drugs with poor stability and easy adulteration, covering three categories of antibiotics, chemicals and proprietary Chinese medicines On May 4, Anhui Provincial Food and Drug Administration said that it would strengthen the market supervision of Bozhou's traditional Chinese medicine, always maintain the high-pressure situation of cracking down on illegal behaviors such as making and selling fake, adulterating, weight-added dyeing, and filling up with inferior ones, resolutely investigate and deal with the behaviors of making and selling fake and inferior traditional Chinese medicine, find out the problems, trace the source, check to the end, and never tolerate At the beginning of May, the Information Office of Hubei provincial government held a press conference on drug supervision The provincial drug administration said that it planned to carry out the next special inspection on the circulation of Chinese herbal pieces, vaccines and category II psychotropic drugs, focusing on the special renovation of "small pharmacies and clinics" and the follow-up inspection of drug retail enterprises In addition to the requirements of the above provinces for strict inspection of Chinese herbal medicines and their pieces, Sichuan, Zhejiang, Gansu, Hainan, Shaanxi and other provinces have entered the remediation period as early as early as April On May 10, a large number of enterprises purchased pieces of Chinese herbal medicines through illegal channels The State Food and drug administration, Chongqing food and Drug Administration and Xinjiang Uygur Autonomous Region issued an announcement A large number of substandard Chinese herbal medicines and pieces of Chinese herbal medicines were exposed The State Food and Drug Administration issued a notice of substandard drugs Seven batches of drugs produced by six enterprises did not meet the requirements, including five batches of Chinese herbal pieces, including peppermint, ginseng and notopterygium root Chongqing food and Drug Administration issued the second drug quality announcement in 2018 Seven batches of drugs have problems, one batch of pieces is suspected of being purchased by the user through illegal channels, and one batch of pieces is improperly preserved in the circulation process, resulting in insect column Xinjiang Uygur Autonomous Region issued the quality announcement of traditional Chinese medicine pieces, 66 batches of traditional Chinese medicine pieces were unqualified, 34 batches of unqualified products were not produced by the marked enterprises, and the main sources of the products were pharmacies and hospitals On May 8, according to the news from the former State Food and drug administration, Shandong food and Drug Administration issued the notice of unqualified drug quality sampling in the fifth period of 2018 72 batches of drugs produced by 49 enterprises were unqualified, and 70 batches of Chinese herbal pieces were unqualified Among them, 37 batches of substandard pieces have been denied production, 4 batches have been stopped production, and 2 batches cannot be found On May 4, Gansu Provincial Food and Drug Administration issued a drug quality announcement, 29 batches of Chinese herbal pieces were unqualified, 3 batches of unqualified pieces were marked as production enterprises denied production by the enterprise, 2 batches of unqualified pieces had been cancelled, and 1 batch of unqualified pieces had objections At the end of April, Hebei food and Drug Administration issued a notice on drug quality, saying that two batches of Chinese herbal pieces were unqualified, and one batch of unqualified pieces indicated that the enterprise denied production The above enterprises deny that many of the drugs that cannot be found are from drugstores, which also means that the drugstore purchases drugs from illegal channels In addition, since May, a large number of Chinese herbal pieces still fail to pass the examination: Sichuan and Shanghai have exposed 26 and 28 batches of unqualified drugs, all of which are pieces; Heilongjiang has exposed 18 batches of unqualified drugs, 13 batches of which are pieces; Henan has exposed 4 batches of unqualified drugs, and 3 batches of which are pieces Five illegal operations of pieces of Chinese herbal medicine in all provinces shall be strictly checked and sorted out, and the following five illegal activities shall be strictly checked, and the drugstores that operate pieces of Chinese herbal medicine in violation of regulations shall also be reminded to close down as soon as possible 1 Purchase and sell Chinese herbal pieces from illegal channels; 2 Purchase and sell fake Chinese herbal pieces; 3 Illegally repackage Chinese herbal pieces; 4 Purchase and sell Chinese herbal pieces without asking for or issuing invoices (including taxable labor list) and accompanying bills, or although there are invoices and other bills, relevant information (unit, product name, specification, batch number, amount, payment direction, etc.) is inconsistent with the actual situation; 5 Failed to store and maintain Chinese herbal pieces as required Attachment: special rectification action plan for Chinese herbal medicine and Chinese Herbal Pieces in circulation field of Jiangxi Province I work objectives Through the rectification action, we will urge the operation and use units of traditional Chinese medicine and Chinese herbal pieces to implement the main responsibility, continuously strengthen the responsibility consciousness, quality consciousness and law-abiding consciousness, and carry out business activities in accordance with the law, norms and self-discipline; increase the supervision and sampling of the market of traditional Chinese medicine and Chinese herbal pieces, strengthen the investigation and punishment of illegal cases, investigate and handle a number of typical cases of making and selling fake products, and severely punish those involved The unit and person in charge of the case shall safeguard the market order of traditional Chinese medicine and Chinese herbal pieces, prevent the occurrence of regional and systematic drug safety risks, and protect the public interest and health rights and interests 2、 Key points for improvement (I) Chinese herbal medicine market of camphor tree and urban and rural market , the supervision of urban and rural markets, cracking down on the production and sale of fake and inferior Chinese herbal medicines such as dyeing and weight gain, adulteration, substandard and fake; investigating and punishing the illegal sale of Chinese herbal pieces, Chinese patent medicines or chemical raw materials and preparations, illegal sale of 28 toxic and 42 endangered Chinese herbal medicines stipulated by the state; investigating and punishing the sale of non self planted and self collected Chinese herbal medicines by Chinese herbal traders in urban and rural markets The real estate of traditional Chinese medicine （2） The wholesale and retail enterprises of Chinese herbal pieces shall strengthen the supervision over the enterprises of Chinese herbal pieces, investigate and deal with the sales of Chinese herbal medicine, Chinese herbal pieces and toxic Chinese herbal medicine beyond the scope according to law, and take measures from the market of Chinese herbal medicine Or the unqualified unit purchases Chinese herbal pieces, fails to operate and store Chinese herbal medicine and Chinese Herbal Pieces in accordance with the requirements of the "quality management specification for drug operation", the drug traceability record is not sound, the illegal affiliation and ticket operation, the illegal sub packaging and label change of Chinese herbal pieces, and the purchase of Chinese herbal pieces with incomplete package label information （3） Medical institutions focus on clinics and private medical institutions in urban and rural areas or remote villages and towns, and severely crack down on the market of traditional Chinese Medicine Or units and individuals without production and operation qualification purchase Chinese herbal pieces, purchase and sell Chinese herbal pieces with incomplete packaging label information, fail to establish and strictly implement the purchase acceptance system of Chinese herbal pieces, and fail to file with the drug supervision and administration department the variety, quantity, processing reason and particularity of the special specifications of Chinese Herbal Pieces for processing as required 3、 In order to strengthen the leadership of this special rectification action, the Provincial Bureau set up the centralized rectification action office of Chinese herbal medicine and Chinese herbal pieces (hereinafter referred to as the "rectification office"), led by the pharmaceutical circulation Supervision Office of the Provincial Bureau, and composed of Zhangshu drug administration, the provincial food and Drug Inspection Bureau, and the complaint and reporting center of the Provincial Bureau The main responsibilities are as follows: first, to be responsible for the command, coordination and scheduling of remediation actions, and to convene meetings And the operation of documents, the collection of working data, the summary of working conditions, the supervision and inspection of all units in all regions, the guidance of all regions to strengthen the supervision of local business enterprises, and effectively regulate the purchase, sale, storage and bill management of Chinese herbal medicine and Chinese Herbal Pieces in the business process Second, coordinate with Zhangshu municipal government, relevant functional departments and industry associations to carry out market regulation of Zhangshu traditional Chinese medicine Establish a cooperation mechanism, form a working force, strengthen the supervision and standardized guidance of Zhangshu market of traditional Chinese medicine and the production, operation and use units of traditional Chinese medicine pieces, timely discover and investigate violations of laws and regulations, and effectively promote the healthy development of Zhangshu market of traditional Chinese medicine (specific responsibility of Zhangshu Drug Administration) third, collect complaints and case clues, investigate and handle cases of transferring illegal Chinese Herbal Pieces in time, supervise the listing of key cases, catch to the end, and severely punish illegal enterprises and counterfeiters (in the charge of the provincial food and Drug Inspection Bureau, with the cooperation of the complaint and report center of the provincial food and Drug Inspection Bureau) IV the implementation steps and work arrangements for the special rectification action will last for 5 months, starting from May 20, 2018 and ending on October 20, 2018 The implementation is divided into three stages: the first stage - mobilization and deployment stage (May 20 to the end of June), each region forms a special rectification work leading organization, develops the rectification work plan, establishes the working mechanism, comprehensively mobilizes and deploys the rectification action and carries out the enterprise self-examination in combination with the characteristics of the local industry In the second stage - organization and implementation stage (July September), according to the work plan and the division of responsibilities, all localities should concentrate their efforts and act quickly, carefully check outstanding problems and weak links, and seriously investigate and punish illegal behaviors The higher departments shall strengthen the inspection guidance and supervision of the lower departments, and the Provincial Bureau shall timely organize the supervision of the work of all regions Since July, the municipal bureaus divided into districts, the pilot county bureaus directly under the provincial government, and the Zhangshu drug administration have reported the work progress (including work progress, existing problems, case investigation and handling) and work data to the Provincial Bureau's rectification action office until the completion of the rectification action The third stage - summarize the rectification stage (October), analyze and summarize the work situation and data, summarize the work results and suggestions, urge the relevant drug distributors and users to rectify in place, and report the work summary to the rectification action office of the Provincial Bureau before October 20 (contact person: Wu fan, pharmaceutical circulation supervision office, Provincial Bureau, Tel: 0791-88178551, email: wstfjc@163.com) v work requirements 1 Strengthen leadership and implement responsibilities The quality and safety of Chinese herbal medicine and Chinese herbal pieces are closely related to people's health and are concerned by all sectors of society All localities should conscientiously perform their responsibilities of territorial supervision, improve their ideological positions, strengthen organizational leadership, clarify the division of responsibilities, refine the rectification measures, quantify the work objectives, and steadily promote the implementation At the first level, we should pay attention to the implementation level by level, and implement the work level by level