"Ginkgo biloba event" severely damaged extract Market and involved in health care products enterprises

Since May this year, the "ginkgo leaf incident" caused by the unauthorized change of the production process of Ginkgo biloba extract by the enterprise has caused a great stir in the industry Moreover, new downstream pharmaceutical and health product enterprises are constantly involved, and the whole plant extraction market is facing a storm of industry consolidation 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 A person in the plant extraction property who did not want to be named told China Business Daily that the industry standard has been in a vacuum state for a long time, and the national pharmacopoeia ginkgo leaf extraction standard process has not been implemented by the production enterprises for a long time, resulting in the whole industry in a long-term chaotic state However, as a rigid demand product, the world's major economies need it Demand is very strong, leading to the growing market size to cover up the negative impact of the lack of standards on the industry According to statistics of China Medical Insurance chamber of Commerce, in terms of export, China's export of plant extracts reached US $1.778 billion in 2014, and US $1.41 billion in 2013, up 26.1% year on year Behind the rapid growth of plant extraction market, the disordered competition in the industry under the lack of standards is expanding rapidly The Ginkgo biloba extract of "zhonggun" is unqualified, and the most direct one is the downstream pharmaceutical enterprises and health products enterprises 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 Yang Junde, Secretary of the board of directors of Kangenbei, said publicly 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 Yunnan Baiyao group said that its subsidiary Chinese medicine resources had purchased 5 batches of 6.9 tons of Ginkgo biloba extract from Guilin Xingda, all of which were sold to Anning Branch of Yunnan Xitao green Pharmaceutical Co., Ltd Yunnan Xitao has one of the largest extraction production bases in Yunnan Province, with an annual processing capacity of 6000 tons of Chinese medicine and a production capacity of over 100 tons of Ginkgo biloba extract However, the above inspection did not end 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 extract, Ginkgo biloba leaves (including dispersing tablets) and Ginkgo biloba leaves capsule products, and 2335 batches of unqualified products 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, and 14 batches of ginkgo leaf dispersive tablets produced by Beijing Sihuan Pharmaceutical Co., Ltd failed, with a failure rate of 13.7% In the list of 21 health food enterprises purchasing unqualified Ginkgo biloba extract exposed at the same time by the State Food and drug administration, 10 enterprises, including Watson Bijian, limitless and Nu Skin, were listed, and were required to "complete the recall before June 25." Among them, the unlimited purchase volume is 2373.49kg, only 924.64kg is sealed, and other raw materials have been made into unlimited Yirui capsule; for example, the new purchase volume is 2050kg, only 101.68kg is sealed, and other raw materials are made into Spirulina capsule of Xinhua Mao brand The product control measures show that the production and sales are stopped However, a person who once worked in the direct selling industry told reporters that due to the large number of direct sellers, it is not easy to completely eliminate the sales of products Niu Zhengqian, vice president of China Pharmaceutical Enterprise Management Association, told reporters that the ginkgo leaf incident did a lot of harm to traditional Chinese medicine enterprises If the source enterprises are not severely punished, traditional Chinese medicine enterprises will suffer from it The impact of this incident on traditional Chinese medicine enterprises is no less than that of poison capsule incident A senior person from the China Health Care Association, who did not want to be named, said that ginkgo leaf producers were not in accordance with laws and standards, which was the main culprit of the incident, and the local drug administration was most responsible for the incident "How many people are there in all? The local drug supervision department of the involved enterprises should be responsible for the ginkgo leaf incident The health care product enterprises have always followed the pharmaceutical enterprises to purchase, and the pharmaceutical enterprises have not found any problems, and the health care product enterprises naturally can not find the problem of raw materials Therefore, this incident should be severely punished for the source enterprises " The senior said In the face of the negative effects from the upstream, the downstream enterprises have begun to claim for compensation Haiwang Bio said that it can be confirmed from the notice of the State Food and Drug Administration on illegal sales of Ginkgo biloba drugs by Ningbo Lihua Pharmaceutical Co., Ltd and the notice on further special treatment of Ginkgo biloba drugs issued by the State Food and Drug Administration (2015) and the notice on further special treatment of Ginkgo biloba drugs issued by Ningbo Lihua Pharmaceutical Co., Ltd Unqualified enterprises purchase Ginkgo biloba extract and sell it to Haiwang pharmaceutical in the name of the enterprise Haiwang pharmaceutical filed a lawsuit, saying that Lihua pharmaceutical's action resulted in that the company's stock of Ginkgo biloba extract, the production intermediate of Ginkgo biloba drugs and the finished Ginkgo biloba drugs could not continue to be produced and sold; while for the previously sold Ginkgo biloba drugs, the company was obliged to recall all of them, and the company would inevitably bear all the costs and losses of the recalled drugs Therefore, Lihua pharmaceutical shall be fully liable for the above inventory loss and recall loss Haiwang pharmaceutical requested Ningbo Lihua to compensate a total of 70.0376 million yuan In addition, Ningbo Lihua should bear the litigation cost of the case Absence In the face of the continuous claims from downstream enterprises, an insider of Ningbo Lihua Pharmaceutical Co., Ltd told reporters that Haiwang biological's claim measures should be regarded as the statement of the board of directors of the company to the shareholders in response to the negative event In fact, Lihua pharmaceutical continues to supply the ginkgo leaf raw materials of Haiwang biological, and the company will be responsible for this part of its mistakes The insider also told reporters that at present, other enterprises are communicating with the company to solve the problem, and the company will try to deal with the problem of compensation for losses with downstream customers However, for the case of Ningbo Lihua being investigated, there are other extraction enterprises in the industry to express sympathy A person in charge of Biotechnology Co., Ltd involved in Ginkgo leaf extraction business in Xi'an told reporters that the plant extract industry itself is not sound, and the process flow and content determination standards of ginkgo leaf extraction in Chinese Pharmacopoeia are difficult to match the actual situation of the industry "Maybe the person who formulated the pharmacopoeia is engaged in academic research and does not know the actual situation of the production enterprise The enterprise does it completely according to the process specified in the Pharmacopoeia The extraction cost is too high According to the current domestic price of Ginkgo biloba extract, no enterprise can make profits In addition, Ningbo Lihua is one of the leading enterprises in the industry If the Ginkgo biloba extract produced by the enterprise does not meet the national standards, more than 90% of the enterprises in the whole industry will not be qualified " The person in charge said In fact, Ningbo Lihua's real mistake this time is to sell the purchased Ginkgo biloba extract to Shenzhen Haiwang Pharmaceutical Co., Ltd and Yangzijiang Pharmaceutical Group Co., Ltd for Ginkgo biloba drug production, and to Wuxi jiante Pharmaceutical Co., Ltd for health food production A person in charge of an extract enterprise in Wuhan told reporters that Ningbo Lihua purchased unqualified Ginkgo biloba leaves to sell to downstream enterprises Although this approach is not right, it also reflects the current situation of the industry to some extent that bad currency is driving away good currency "At present, gingko leaf extraction market is a kind of goods and a kind of price, with the price per kilogram ranging from 100 yuan to 400 yuan For a long time, the drug regulatory department lacks effective supervision on this industry, and downstream enterprises also choose suppliers according to the actual price of raw materials Ningbo Lihua may have made a wrong response in the face of the continuous decrease of suppliers." The person in charge added The person in charge's statement is prevalent in the industry Recently, Yangzijiang Pharmaceutical Co., Ltd has publicly stated that its Ginkgo biloba extract and Ginkgo biloba leaves have passed the EU GMP certification and obtained the EU GMP certification, becoming the first Ginkgo biloba extract and Ginkgo biloba leaf manufacturer in China to obtain the EU GMP certification However, Yangzijiang pharmaceutical, which has excellent ginkgo leaf extraction capacity, found that the products were unqualified in the process of self inspection of all batches of Ginkgo leaves produced since January 1, 2014 According to the company's official website on June 15, the self inspection results of nine batches of Ginkgo leaves were all unqualified, and the corresponding ginkgo leaf extract supplier was Ningbo Lihua pharmaceutical However, the company did not explain the source of raw materials for the other 252 unqualified batches In fact, China's extract industry has a long history of lack of standards Why did Ginkgo biloba extract break out this year? According to industry insiders, China's extract industry has always been highly dependent on the international market, with 80% of its products exported to foreign countries; while Europe and North America, as the world's largest consumer regions of plant supplements and herbal medicines, 70% of its plant-based raw materials come from China Although China's plant extract industry has a certain level of scientific and technological research and development, and occupies an absolute supplier position in the market, the lack of standards in this industry is an indisputable fact The confusion of product quality standards in plant extract industry has brought obstacles to production and operation to some extent For example, as the main export market of plant extracts in China, the United States and Europe account for more than half of the total export of plant extracts in China Due to the strict quality standards of plant extracts implemented by developed countries such as Europe, America and Japan, domestic enterprises are under great pressure This situation has been intensified in 2015, and this year is a key year for the development of Ginkgo biloba extract industry In terms of the external macro environment, due to the weakening of the export of traditional Chinese patent medicines, the international market will increase the demand for plant extracts; with the revision and continuous improvement of the quality standards of EGb (Ginkgo biloba extract) in the United States Pharmacopoeia and the European Pharmacopoeia, foreign enterprises have gradually developed and expanded their ginkgo planting bases and industrial bases in China, which has a significant impact on the EGb industry in China; In addition, strict energy conservation and emission reduction and rising labor cost have a profound impact on the development of Ginkgo biloba extract industry "At present, there is no specific standard for the extract industry Although the standard of Ginkgo biloba extract proposed by our chamber of commerce is proposed by the association