Stop the extraction of traditional Chinese medicine and entrust the processing industry with limited influence

Source: pharmaceutical economic daily, January 7, 2016, CFDA issued the announcement on the implementation of relevant provisions on the supervision and administration of extraction and extraction of traditional Chinese medicine, which is required to start from January 1 this year From now on, any Chinese patent medicine manufacturing enterprise that does not have the ability of pre-treatment and extraction of traditional Chinese medicine will stop the production of corresponding varieties of traditional Chinese medicine If it does not stop production within the time limit, it will be seriously investigated and punished in accordance with the drug administration law; meanwhile, the production and use of traditional Chinese medicine extracts must be put on record "The entrusted processing of traditional Chinese medicine extraction has been stopped in the industry for a long time, which is also in line with expectations, and has gone through a transitional period The implementation is natural and will not cause a" big shock " Some industry people said in an interview with our reporter It is reported that in view of the outstanding problems in the extraction process of traditional Chinese medicine, the competent department issued the notice on strengthening the supervision and management of extraction and extraction in the production of traditional Chinese medicine (sfjyhj [2014] No 135, hereinafter referred to as No 135) as early as July 2014, which clarified the management requirements for extraction and extraction of traditional Chinese medicine and stipulated the transitional period; may 2015 In January 2016, the relevant notice on the special treatment of Ginkgo biloba drugs was issued, and the relevant person in charge also stressed at the relevant meeting that since January 1, 2016, the production of traditional Chinese medicine can no longer be entrusted for extraction, and the purchased extracts must be in accordance with the laws and regulations "The prohibition of the entrusted processing of Chinese herbal extracts involves Chinese patent medicine enterprises in China As the current domestic plant extract enterprises are mainly export-oriented, the impact of the suspension of the entrusted processing of Chinese herbal extracts on the plant extraction industry is not expected to be significant." Yu Zhibin, deputy director of the traditional Chinese Medicine Department of China Chamber of Commerce for the import and export of medical and health care products, analyzed that the country started from the safety of the traditional Chinese medicine industry, because there were potential risks in the previous entrusted processing, the restrictive measures were to improve the quality and control the risks Production and use of traditional Chinese medicine extract shall be recorded Before that, the relevant responsible person of the competent department pointed out in public that there are some outstanding problems in the supervision of traditional Chinese medicine extraction and traditional Chinese medicine extraction, which are mainly manifested as follows: first, some Chinese patent medicine enterprises do not have the extraction ability, and it is difficult to guarantee the quality of drugs produced by purchasing illegal extracts; second, the relevant management system is not perfect, and there are still some problems in enterprise responsibility, supervision responsibility and qualitative punishment Loopholes; third, the existing drug regulatory laws and regulations do not clearly define the regulatory attributes of traditional Chinese medicine extracts, the production and use of traditional Chinese medicine extracts are not clear, and they are isolated from the whole process of drug quality regulatory system From the perspective of the industry, on the one hand, due to the limitations of extraction equipment and technology, or limited production capacity, the extraction of traditional Chinese medicine by some proprietary Chinese medicine manufacturers depends on entrusted processing; on the other hand, some professional traditional Chinese medicine extraction manufacturers do not have varieties of proprietary Chinese Medicine, so they specialize in extraction In the industry, the phenomenon of self built workshop extracting and purchasing extract feeding coexists, and a few enterprises neglect the quality responsibility requirements such as quality standards, quality monitoring, technical guidance, etc in the entrusted processing This announcement made it clear that since January 1, 2016, the Chinese patent medicine national drug standard prescription items will be downloaded, and the Chinese herbal extracts with separate national drug standards will be put on record In this regard, experts introduced that 47 varieties including clove basil oil, star anise oil, total ginsenoside of ginseng stem and leaf and the standards of Chinese herbal extracts approved by the competent authorities under the catalogue of plant oils and extracts in the first volume of 2015 edition of Chinese Pharmacopoeia belong to the category of Chinese herbal extracts, according to the detailed rules for the record management and implementation of Chinese herbal extracts (see 135 No document attachment) provides for the filing management The reporter noted that No 135 document proposed that "the extract of traditional Chinese medicine will no longer be managed according to the approval document number, except for the effective ingredients and effective parts of traditional Chinese medicine approved according to new drugs After the expiration of the validity period of the original approval number, the food and Drug Administration of each province (district or city) will not accept the re registration application for the Chinese herbal extracts which have obtained the approval number and should be included in the record management according to the provisions of this circular " The above experts said that the original approval number management of Chinese herbal extracts on the market has certain defects "For example, most of the enterprises involved in Ginkgo biloba have approval numbers, but there are problems such as approval documents of sales numbers and confusion of sources, so the approval numbers may be cancelled in the future." In the interview, some experts pointed out that after the entrusted processing was stopped, if the Chinese patent medicine enterprises want to continue production, they must either build their own workshops, or stop production, or put on record After filing, pharmaceutical manufacturers and users are bound together and cannot be replaced casually In case of quality problems, the source of responsibility can be determined soon Encourage pharmaceutical enterprises to build their own extraction workshops Although some kinds of traditional Chinese medicine extracts can be purchased, considering that the current plant extraction industry is still far behind the national requirements, some industry experts suggest that the best way is to build their own extraction workshops That is to say, according to the production needs of the enterprise, standardize the extraction process of traditional Chinese medicine, pay attention to the control of the production process of traditional Chinese medicine, establish strict quality control standards, and promote the standardization of products In this way, it can not only ensure the quality uniformity between batches, but also help to improve product quality and avoid quality risks It is reported that before and after the transition period, due to the rigid regulations of "stop the production of corresponding traditional Chinese medicine varieties for those traditional Chinese medicine manufacturers that do not have the ability of pre-treatment and extraction of traditional Chinese medicine", many traditional Chinese medicine extraction manufacturers and users actively follow up and invest more in their own traditional Chinese medicine extraction ability For example, Heilongjiang Zhonggui Pharmaceutical Co., Ltd has a total investment of 160 million yuan, mainly building new plants and production lines such as traditional Chinese medicine extraction workshop After being put into production, the annual extractable traditional Chinese medicine includes 1500 tons of pre-treatment of traditional Chinese medicine Kangyuan Pharmaceutical Co., Ltd has invested 4.8% with Zhejiang University and other universities Billion yuan design and build a new generation of Chinese medicine injection extraction and refining digital chemical plant; Guangdong Nanguo pharmaceutical also issued a notice on equipment procurement of Chinese medicine extraction workshop.