No extraction capacity of traditional Chinese Medicine

The rectification of traditional Chinese medicine will be carried out again Chinese patent medicine enterprises without the ability of extracting traditional Chinese medicine will stop production from this year! Recently, the official website of the State Food and Drug Administration issued the announcement on the implementation of the relevant provisions on the supervision and administration of the extraction and extraction of traditional Chinese medicine, which clearly pointed out that since 2016, any Chinese patent medicine production enterprise that does not have the corresponding extraction capacity must stop production With the rapid expansion of the market of Chinese herbal extracts to the scale of 30040 billion yuan, there are many problems in the extraction process The new policy aims to ensure the quality and safety of Chinese patent medicine and encourage enterprises to build their own production lines It also means that the industry reshuffle will eliminate some small and medium-sized enterprises that are "cash in the bag", while the listed companies are more likely to benefit It is reported that the production and use of traditional Chinese medicine extracts must be recorded The State Food and Drug Administration previously issued the notice on strengthening the supervision and management of extraction and extract in the production of traditional Chinese medicine in July 2014, which clarified the management requirements of extraction and extract of traditional Chinese medicine and stipulated the transition period According to the announcement, any Chinese patent medicine manufacturer that does not have the corresponding extraction capacity must stop production from 2016 Local food and drug administration shall stop approving the entrusted processing of extraction of traditional Chinese medicine; for the approved entrusted processing of extraction of traditional Chinese medicine, drug manufacturers shall stop the entrusted extraction from January 1, 2016; for the production enterprises of traditional Chinese medicine that do not have the ability of pretreatment and extraction of traditional Chinese medicine, the production of corresponding varieties of traditional Chinese medicine shall be stopped from 2016 The latest announcement pointed out that since January 1, 2016, the production and use of Chinese herbal extracts must be recorded In the future, local regulatory authorities will strictly review the scope of Chinese herbal extracts for filing, and will not file those that do not belong to the scope of filing; those that have been filed must be cancelled Any Chinese patent medicine manufacturing enterprise that does not have the ability to extract traditional Chinese medicine shall not renew the drug production license; for the enterprise that produces the extract of traditional Chinese medicine alone, the drug production license shall not be issued Many impurities in the extract are easy to cause adverse reactions The reporter interviewed the insiders and learned that the phenomenon of entrusted processing of traditional Chinese medicine extraction was very common before, and there were many problems exposed "The extraction of traditional Chinese medicine, especially the extraction of compound prescription, is a complex process, and the level of extraction process is still a weak point for many Chinese patent medicine enterprises Many of the adverse reactions of clinical traditional Chinese medicine injection frequently exposed by the General Administration of food and drug administration were caused by unclean impurities and allergy of human body to drugs " An insider told reporters Just last year, after the recall of "Shuxuening" injection, the core product of China Resources Sanjiu (22.54, 0.45, 2.04%), the "Shengmai Injection" produced by Jiangsu Suzhong Pharmaceutical Co., Ltd was also exposed with adverse reactions The State Food and Drug Administration issued a notice requiring the recall of more than 30000 "Shengmai Injection" However, the Ginkgo biloba extract scandal has caused many listed pharmaceutical companies to "win the bidding" As a result of outsourcing Ginkgo biloba extract to replace their own extraction, the source quality control is seriously absent In response, Zhang Bin, an analyst in the traditional Chinese medicine industry, said that at present, only the main substances are detected for the extracts of traditional Chinese medicine injections, while the detection standard for the accessories is temporarily insufficient However, it is difficult to fully confirm the safety of many kinds of Chinese herbal medicines or some rare herbal medicines because they contain many unknown substances.