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    Home > Medical News > Latest Medical News > Local rules for the management of traditional Chinese medicine formula granules are implemented!

    Local rules for the management of traditional Chinese medicine formula granules are implemented!

    • Last Update: 2021-07-30
    • Source: Internet
    • Author: User
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    On July 27, the Hainan Provincial Food and Drug Administration and other four departments jointly posted the "Implementation Rules for the Management of Hainan Traditional Chinese Medicine Formula Granules (Trial)" (hereinafter referred to as the "Implementation Rules"), which will be implemented on November 1, 2021


    Establish the only procurement channel


    What attracts people’s attention is that Hainan’s practice is to set up a traditional Chinese medicine formula granule section on the provincial drug procurement platform, formulate and publish the corresponding tender rules


    On this designated procurement platform, medical institutions should sign quality assurance agreements with manufacturers of traditional Chinese medicine formula granules


    According to requirements, starting from November, Chinese medicine formula granules shall not be sold outside medical institutions


    That is to say, the hospital channel will be the only use channel of Chinese medicine formula particles


    New round of beach game

    The strong one is always strong


    Taking Hongri Pharmaceutical as an example, Shandong Shanghe's intelligent manufacturing base for traditional Chinese medicine formula granules with an annual output of 3,000 tons started construction in June, making it one of the most concerned beachheads during the New Deal window period


    According to the 2020 financial report of Hongri Pharmaceutical, there are more than 600 kinds of Kangrentang traditional Chinese medicine formula granule products


      For Chinese medicine formula granule companies, there are also opportunities and challenges: on the one hand, the New Deal clarifies that Chinese medicine formula granules can be used in all medical institutions, which is optimistically beneficial to the entire industry; on the other hand, as the industry is officially opened, more manufacturers enter While the industry continues to grow at a high speed, competition will become more intense, which will test the company's supply chain capabilities


      In the face of this systemic competitive landscape, even China Traditional Chinese Medicine and China Resources Sanjiu, the leading companies in traditional Chinese medicine formula granules, dare not slacken in the slightest


      The focus is on integration


      China Resources Sanjiu also produces more than 600 varieties of single-flavor formula granules, but one of its very important "hands" is to vigorously provide high-quality Chinese medicine formula granules and decoction pieces to enhance the competitiveness of the industry chain


      In contrast, Peili Holdings, which focuses on the market of concentrated Chinese medicine formula particles, is taking another path: In terms of the production of concentrated Chinese medicine formula particles, Peili Holdings also has 600 kinds of single formula particles and more than 130 kinds of classic compound formula particles.


      From the perspective of competition, six well-known companies, including China Resources Sanjiu, Jiangyin Tianjiang Pharmaceutical, Hongri Pharmaceutical Kangrentang, Peili Pharmaceutical, and Sichuan New Green Pharmaceutical, are in the market for food-sharing traditional Chinese medicine formula granules


    Strengthen basic research

    Control the raw materials and improve the quality standards

      


      In traditional Chinese medicine formula granules, stable production of different batches of the same product has always been the focus of attention
    .
    Some experts have said bluntly a few days ago, "Encourage the liberalization of the quality standards of formula particles, and emphasize the quality view with enterprises as the main body
    .
    For example, enterprises can make preparations for modern quality control such as infrared fingerprint spectroscopy in advance
    .
    In view of this, pharmaceutical companies should strengthen research and formulate The key to standards is to strengthen basic research, optimize processes, and maximize the advantages of formula particles
    .
    "  

      In fact, the key to traditional Chinese medicine formula granules is to control the raw material.
    The problems of authenticity, artificial cultivation and wildness are also crucial
    .
    Ensuring the quality and quality of traditional Chinese medicine formula granules requires quality control throughout the entire process, and it is not a single indicator that can be controlled
    .
    Experts say that the core issue of formula granules is standard and quality problems, and standard decoction is a standard reference for measuring the clinical efficacy of formula granules
    .
      

      Difficulties such as the problems of multi-base raw medicinal materials, the inconsistency of processing technology, the problem of single co-decoction, and the incomplete quality standards of traditional Chinese medicine formula granules need to be solved urgently
    .
    Establish a quality standard system with standard decoctions as the core, and compare traditional Chinese medicine formula granules with standard decoctions to ensure the consistency of the quality of the two
    .
    The quality control index of formula granules is not equal to the quality control index of the national standard for medicinal materials or decoction pieces, and the same standard decoction should be used as the standard
    .
    At present, formula granules are facing the status quo of uneven quality.
    When making evaluation standards, we must face up to the differences in quality.
    Products of the same company and the same brand must pursue uniformity and stability.
    It is the formula granules to achieve high quality and good price through brand building.
    Way out
    .

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