Behind the "Ginkgo Leaf Incident": The plant extract market encounters growing troubles

Since May this year, the "ginkgo leaf event" continued to ferment due to the unauthorized change of the production process of ginkgo leaf extract On June 22, the State Food and Drug Administration issued a circular on the self inspection of 90 Ginkgo biloba extract and Ginkgo biloba drug manufacturers, saying that after self inspection, the batch number of unqualified products was 2335, accounting for 45% of the total batch number In other words, nearly half of the products are not up to standard Behind the disqualification of a large number of Ginkgo biloba extract products, is the rapid expansion of China's plant extract market scale Statistics from China Medical Insurance chamber of Commerce show that in 2014, China's export of plant extracts reached 1.778 billion US dollars, accounting for 49.48% of China's export of traditional Chinese medicine products "Behind the Ginkgo biloba incident is the barbaric growth of the extract market," Shi lichen, head of medical consulting at Dingchen, Beijing, told China Economic Net This market needs to be regulated and renovated by the regulators I believe that the industry will gradually go on the right track in the future " "Ginkgo leaf incident" continued to ferment ginkgo leaf raw materials because of a flight inspection by the regulatory authorities In May this year, the State Food and Drug Administration announced that during the flight inspection of enterprises selling Ginkgo biloba drugs at low prices, it was found that some ginkgo biloba drug manufacturers such as Guilin Xingda Pharmaceutical Co., Ltd had serious violations such as using fake and inferior raw materials to produce drugs In order to reduce the production cost and seek illegal benefits, these enterprises change the production process of Ginkgo biloba extract without authorization and reduce the drug efficacy Since then, the special treatment of Ginkgo biloba drugs has begun On May 20, the State Food and Drug Administration issued the notice on illegal production and sale of Ginkgo biloba drugs by Guilin Xingda Pharmaceutical Co., Ltd and the notice on special treatment of Ginkgo biloba drugs, and began to track down the Ginkgo biloba drug industry for several times and launched a clean-up war On May 21, the State Food and Drug Administration held a teleconference on the special treatment of Ginkgo biloba drugs, stressing that the existing case clues should be checked to the end, and the 24 drug manufacturers who purchased illegal Ginkgo biloba extract from Guilin Xingda Pharmaceutical Co., Ltd should be checked one by one Once problems are found, they should stop selling, stop using, check the flow direction, recall products, suspend production and other measures should be taken immediately To impose and severely punish the illegal acts of enterprises in accordance with the law At the same time, the meeting also made it clear that the Ginkgo biloba drug market should be comprehensively cleaned up, and regulatory authorities at all levels should organize a comprehensive inspection of all Ginkgo biloba extract and Ginkgo biloba preparation manufacturers in their respective jurisdictions Any problems found must be severely punished We should strengthen the crackdown on illegal extracts, strive for the support of the public security organs, and resolutely investigate and crack down on illegal extract production enterprises On June 8, the State Food and drug administration again issued a circular and a supplementary inspection method for Ginkgo biloba drugs, requiring each Ginkgo biloba extract manufacturer and Ginkgo biloba drug preparation manufacturer to conduct batch by batch inspection on all Ginkgo biloba extract, Ginkgo biloba leaves and Yinxingye capsules produced by the enterprise since January 1, 2014 Up to now, the inspection of Ginkgo biloba extract has been carried out in many parts of the country On May 25, after the centralized training of Shaanxi food and drug administration, 40 drug safety inspectors from the whole province were divided into 20 law enforcement groups and sent to drug production and trading enterprises throughout the province to carry out large-scale screening From June 17 to 19, Suqian food and Drug Administration completed the tasks of sampling, basic information input, sample delivery and so on in the spot of special supervision and sampling of Ginkgo biloba drugs issued by the provincial administration in a three-day period 10 varieties of Ginkgo biloba drugs were verified one by one at the sampling site, and 23 drug-related units in the city were successively supervised, inspected and verified for sampling Up to now, 9 batches of samples have been taken in the city At the same time, on-site inspection has been carried out and on-site sampling has been carefully recorded On June 23, according to Xinhuanet, Fujian food and drug administration has issued a notice to conduct law enforcement inspection on the enterprises that use Ginkgo biloba extract to produce health food It is worth noting that many listed companies are involved in this ginkgo leaf incident According to the State Food and drug administration, illegal ginkgo leaf extraction and logistics have entered Yunnan Baiyao, Kangenbei, Qianyuan pharmaceutical, Fangsheng pharmaceutical and other listed companies Ningbo Lihua Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Longsheng Pharmaceutical Co., Ltd., a Hong Kong listed company, also has the same situation Relevant notices, including the raw material medicine Ginkgo biloba extract of Rongchang pharmaceutical, Hansen pharmaceutical, Shijiazhuang Huaxin pharmaceutical and Beijing Sihuan pharmaceutical, are provided by Kangenbei The four pharmaceutical companies purchased 3.6 tons of Ginkgo biloba extract from Kangenbei Mr Yang Junde, Secretary of the board of directors of Kangenbei, said that in addition to the 3.6 tons sold, the remaining 3.3 tons of extract had been sealed in the company's warehouse The 6.9 tons of Ginkgo biloba extract are all supplied by Yunnan Baiyao subsidiary traditional Chinese medicine resources company In his letter to customers, Kangenbei acknowledged that the trust of the raw material problem factor company in Yunnan Baiyao brand and its quality management was caused by failing to perform the necessary audit procedures, "but this trust has greatly harmed our company and relevant downstream enterprises." Yang Junde said that due to the company's improper management, which caused irreparable losses to customers, the company is still in further consultation with customers on the compensation issue, and the company will bear the resulting losses The reporter of China Economic Net noted that the products of Tianbaoning brand ginkgo leaf and ginkgo leaf capsule under Kangenbei were listed as the key products of the company According to the previous 2014 annual report released by Kangenbei, the company's Ginkgo biloba extract products are in short supply, but limited by production capacity, the revenue increased by 22% to 61 million yuan In 2013, the sales revenue of Tianbaoning brand has exceeded 200 million yuan At the same time, the subsidiary Yunnan Xitao has "one of the largest extraction production bases in Yunnan Province, with an annual processing capacity of 6000 tons of Chinese herbal medicines and a production capacity of over 100 tons of Ginkgo biloba extract." On June 22, the website of the State Food and Drug Administration issued a notice again, announcing the self inspection results of 90 ginkgo leaf drug manufacturers Since January 1, 2014, 90 enterprises have produced 5161 batches of Ginkgo biloba leaf extract, Ginkgo biloba leaf (including dispersing tablets) and Ginkgo biloba leaf capsule products, and 2335 batches of unqualified products, accounting for 45% of all batches According to the circular, there are 55 enterprises that have detected unqualified products through self inspection report Among them, there are 30 enterprises that all batches of products are unqualified, including Tianjin Yabao Pharmaceutical Technology Co., Ltd., Harbin Pharmaceutical Group Shiyitang pharmaceutical factory, Jiangsu Runbang Pharmaceutical Co., Ltd., etc 25 enterprises failed in some batches of products, 14 batches of ginkgo leaf dispersible tablets produced by Beijing Sihuan Pharmaceutical Co., Ltd failed, with a failure rate of 13.7%; 20 batches of ginkgo leaf capsules produced by Shandong Baicao Pharmaceutical Co., Ltd failed, with a failure rate of 71.4% There are 35 qualified enterprises The market of plant extracts needs to be standardized Ginkgo biloba extract is widely used in medicine, health products, food additives, functional drinks and cosmetics The problem found by the regulatory authorities in the flight inspection was that some enterprises changed the extraction process without authorization, using 3% hydrochloric acid instead of dilute ethanol to prepare Ginkgo biloba extract, while according to the national production standards, dilute ethanol should be used for extraction According to the State Food and drug administration, there is a risk of "decomposing the effective ingredients of drugs and affecting the efficacy of drugs" by changing the extraction process without authorization According to the introduction, 3% hydrochloric acid extraction can not only reduce the cost, but also improve the yield and shorten the basic process time According to Yu Zhibin, the Ministry of traditional Chinese medicine of China Chamber of Commerce for the import and export of medical and health products, the cost per ton can be saved by 3% hydrochloric acid extraction "Ginkgo biloba extract has systematic risks in the market Once there are problems, the disadvantages of the whole industry have been exposed." Industry insiders said the incident reflected the risks of outsourcing raw materials and the lack of regulatory standards for plant extract industry Behind this systematic risk, the rapid development of plant extract Market in recent years is also the consensus of the industry "At present, the total market volume of domestic plant extracts in the pharmaceutical industry is about 20 billion in 2014, and about 10 billion in the health care industry Moreover, this data has been showing explosive growth for five consecutive years, which shows that the market demand of plant extracts is increasing." According to statistics of China Medical Insurance chamber of Commerce, in 2014, China's export of plant extracts reached 1.778 billion US dollars, accounting for 49.48% of China's export of traditional Chinese medicine products Relevant data also revealed that in 2014, China exported plant extract products to 133 countries and regions, among which Asia, Europe, North America and other traditional markets ranked the top, accounting for 92% of the total export volume Among the three continents, ASEAN's performance is particularly eye-catching, with the annual export volume reaching 323 million US dollars, an increase of 74.81 percentage points on a year-on-year basis, which has also become the main driving force for Asia to achieve 38.59% growth on a year-on-year basis; the EU and North America also performed well, with the export volume reaching 344 million US dollars and 356 million US dollars, respectively, an increase of more than 10 percentage points on a year-on-year basis; although Africa and Latin America have a small share, they have a year-on-year growth rate It also reached 53.65% and 29.36% Some insiders pointed out that at present, the plant lifting industry is developing rapidly and the market scale is expanding rapidly, but the relevant industry standards are still very scarce, which needs to be established and improved Although in recent years, China's export of plant extract products has been on the rise, but the share in the international market is still small, and there is a huge gap with Japan and South Korea's plant extract industry development The international status of China's plant extract products does not match the status of the traditional big country of plant medicine seriously It is imperative to improve the industry access threshold, formulate the standards of plant extract products, and realize the sustainable development of the industry Eyebrows However, in his view, the domestic extract market is not a problem without industry standards, but the lack of enterprise implementation "From the current point of view, the punishment measures are mainly the recall of drugs involved, and the deterrent force to enterprises is not strong The low cost of violations has led many companies to disregard industry standards, "Mr schlichen said.