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    Home > Active Ingredient News > Drugs Articles > It's banned by a large number of drugstores. It's too difficult to make Chinese herbal pieces

    It's banned by a large number of drugstores. It's too difficult to make Chinese herbal pieces

    • Last Update: 2019-12-03
    • Source: Internet
    • Author: User
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    [industry trends of pharmaceutical network] recently, Shandong Provincial Drug Administration issued the measures for the classified management of drug retail enterprises in Shandong Province (hereinafter referred to as the measures), which was implemented in the whole province as of December 1 It is worth noting that, according to the requirements, the first type of stores shall prohibit the sale of prescription drugs, biological products, Chinese herbal pieces, second type of psychotropic drugs, compound oral solutions containing narcotic drugs, etc.; the second type of stores shall prohibit the sale of biological products, Chinese herbal pieces, etc It can be seen from this that the state is very strict in the supervision of Chinese herbal pieces In fact, since the Ministry of Commerce issued the notice on public consultation on the guidance for classified and classified management of national retail pharmacies (Draft for comments) on September 17, it pointed out that by 2020, the classified and classified management system of retail pharmacies in most provinces and cities across the country will be basically established, and by 2025, the unified regulatory and policy system for classified and classified management of retail pharmacies nationwide will be basically established The implementation of classified management in national drug retail enterprises has officially opened the curtain With the promotion and implementation of this policy in a wide range, the restriction and influence on the enterprises of Chinese herbal pieces are also expanding day by day In fact, in recent years, with the improvement of Pharmacopoeia standards and the increasing strength of inspection by regulatory authorities, the life of Chinese Herbal Pieces enterprises has been difficult Especially since this year, it can be found that the new drug quality announcements issued by many local drug administrations are more or less related to Chinese herbal pieces For example, on November 22, 2019, Heilongjiang Drug Administration issued a notice saying that 11 batches of Chinese herbal pieces were unqualified after inspection From the list of 11 batches of unqualified Chinese herbal pieces, 11 batches of drugs from 10 manufacturers are involved The unqualified items in this sampling inspection include: properties, impurities, total ash, etc On November 28, Shandong Provincial Food and Drug Administration issued a notice on sampling inspection of drug quality (issue 6, 2019) According to the notice, after verification and confirmation, 40 varieties and 98 batches of drugs from 62 production enterprises (preparation units) did not meet the standard requirements after sampling inspection In the list of unqualified drugs, almost all are Chinese herbal pieces Subsequently, Fujian Province and Sichuan Province Drug Administration issued a list of drugs that did not meet the requirements of the standards, most of which were also pieces of traditional Chinese medicine With the formal implementation of the new "Drug Administration Law" on December 1, industry insiders said that the days of Chinese herbal medicine enterprises may be more difficult Because Chapter 11 and Article 117 of the new drug administration law clearly stipulate that, in addition to confiscating the illegally produced and sold drugs and illegal income, those who produce and sell substandard drugs will also be fined not less than 10 times but not more than 20 times the value of the goods In addition, if the Chinese herbal pieces produced and sold do not meet the drug standards, even if the products do not affect their safety and effectiveness, they will still be fined between 100000 yuan and 500000 yuan Due to the different producing area, growing environment, altitude, harvesting time, weather, natural disasters, harvest year and other factors, there are often "uneven and unstable" phenomena in the specification, internal and external quality of Chinese herbal medicine and Chinese herbal pieces As a result, even if the production enterprises pass the sampling inspection, it is very easy to "capsize" due to the content, ash, agricultural residues, heavy metals or excessive water content in the inspection of the regulatory authorities This may be the reason why at present, although the regulatory authorities are doing their best in the industry inspection, and the enterprises are also doing their best in production, but there are still many production units of Chinese herbal pieces, and a batch of products are exposed repeatedly because of their unqualified quality On the whole, in the face of the current reform of the pharmaceutical industry in full swing, from the current implementation of the new drug management law, and the future regulatory level will continue to pursue the high-pressure situation of regulatory measures, if the relevant enterprises still cling to the old way of "muddling along", it is no longer feasible With the development of science and technology, the types of Chinese herbal pieces should be diversified, including increasing the research and development of granular pieces, compressing pieces, small package pieces, ultra micro pieces (broken wall pieces), directly taking pieces (beating powder), micro pieces, mobile pieces, etc It is possible to achieve automatic dispensing and improve the decocting rate based on the product innovation of micro pieces, so as to break the restrictions and expand the application of pieces In addition, Chinese herbal medicine enterprises can also try "one-stop" production, that is, from the cultivation of medicinal materials to the processing of producing areas to the preparation of extracts, or the preparation of proprietary drugs, to the processing, to the dispensing, to the application of formula, etc., to form a virtuous circular industrial chain, reduce production costs and improve production efficiency At the same time, we should better form the standard, make the quality stable and controllable, and improve the core competitiveness of Chinese herbal pieces.
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