The producers of fake and shoddy Ginkgo biloba extract are suffering an unprecedented severe blow.
2015110.5, official website. The US Food and Drug Administration posted a punishment opinion, and classified Ginkgo biloba extract that was not produced according to the relevant technology as counterfeit or inferior medicine, and punished it according to the relevant provisions of the Drug Administration Law on the production and sale of counterfeit and inferior medicines.
Ginkgo biloba leaves, as a common raw material of health care products, have therapeutic and preventive effects on cardiovascular and cerebrovascular diseases and can be used as medicine to make health care products. According to statistics, the total sales of various ginkgo preparations, various ginkgo health foods and cosmetics containing ginkgo extract in the world market have exceeded 5 billion US dollars.
However, according to the announcement of the US Food and Drug Administration, the unqualified rate of 90 kinds of Ginkgo biloba extracts, Ginkgo biloba leaves (including dispersible tablets) and Ginkgo biloba capsules in China reached 45 {BF}-that is to say, nearly half of the Ginkgo biloba products you put into your mouth may involve illegal extraction.
This is a war that has dragged on for half a year. From 2065438+May 2005, the State Food and Drug Administration of the United States held continuous telephone conferences, and jointly with local regulatory authorities, launched a nationwide special campaign to crack down on inferior Ginkgo biloba extract. The investigation information of Shandong, Fujian, Sichuan, Hunan, Guangxi and other provinces has been published on the official website of the Food and Drug Administration.
Behind the tiny Ginkgo biloba leaves, the chaotic situation of plant extract industry in China and even the world is gradually being uncovered.
The General Administration "uncovered the lid".
Wang Tiehan, spokesman of the US Food and Drug Administration, told Southern Weekend that the source of the "Ginkgo biloba incident" was only "a normalization work".
2065438+At the beginning of May, 2005, the State Food and Drug Administration of the United States found that the price of ginkgo products was obviously lower than the cost in the provincial bidding procurement in Hunan and Guangxi provinces. "You said 180 yuan, you bought it with 80 yuan, and the price was malicious against market principles. There must be a problem. " Wang Tiehan said.
The first one was found to be Guilin Daxing Pharmaceutical Co., Ltd. The key to the "cheapness" of its products was to use 3{bf} hydrochloric acid instead of dilute ethanol in the process of extracting Ginkgo biloba leaves. The latest edition of China Pharmacopoeia also stipulates the use of dilute ethanol. According to the Drug Administration Law, Guilin Daxing's behavior violated the stipulation that "Chinese herbal pieces must be processed according to national drug standards".
"This is something we will never advocate." Wang Fei, a professor at Nanjing Forestry University, told Southern Weekend that replacing dilute ethanol with 3{bf} hydrochloric acid can speed up the extraction, but at the same time, the effective components in Ginkgo biloba leaves are also decreasing.
More importantly, Guilin Daxing Pharmaceutical Co., Ltd. not only produces unqualified Ginkgo biloba extract by itself, but also buys Ginkgo biloba extract produced by hydrochloric acid method from unqualified enterprises for producing Ginkgo biloba leaves. In addition, they also forged raw material purchase ledgers and production inspection records, and resold non-compliant extracts to other pharmaceutical manufacturers.
According to public information, * * * 24 pharmaceutical manufacturers bought illegal Ginkgo biloba extract from Guilin Daxing Pharmaceutical Co., Ltd., and they went to Heilongjiang in the north and Guangdong in the south, including many well-known brands such as Hengwei Pharmaceutical and Qili Pharmaceutical.
According to the survey, there are many reasons for enterprises to buy Ginkgo biloba extract. "Many enterprises buy tons of extract, and the least enterprises only buy one kilogram." Some enterprises are directly used in the production of drugs or health care products, some enterprises are used in scientific research, and some enterprises-this enterprise only bought one kilogram of extract-are only purchased and maintained by the boss himself, but they are also notified by name on the website of the Food and Drug Administration.
The investigation of Ginkgo biloba leaves is like a fast-paced tap dance, and the baton is always held by the State Food and Drug Administration.
Since the beginning of May, inspectors from the Drug Supervision Bureau of the Food and Drug Administration have rarely appeared in the office. On May 20th, one day after the notice was issued, the food and drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government received the annex of the notice issued by the State Food and Drug Administration of the United States, together with a notice:
All localities immediately organized all enterprises producing Ginkgo biloba extract and Ginkgo biloba preparation within their respective administrative areas to conduct a comprehensive inspection, and the inspection results of all enterprises were reported to the General Administration before May 30, 20 15.
"Comprehensive inspection, collective recall. But in fact the recall is not so easy. " Miao Baoying, deputy director of Nantong Food and Drug Administration, Jiangsu Province, said that most drug traceability systems did not trace back to the production stage of raw materials. Ginkgo biloba leaves, as raw materials of medicines, health products and foods, are extremely difficult to trace back.
Since it is difficult to trace back, the regulatory authorities have found another way. On June 8, the State Food and Drug Administration of the United States announced the laboratory methods for detecting fake and shoddy ginkgo products. The published inspection method can help enterprises to monitor the legality of Ginkgo biloba raw materials from the final products on the market.
"In my opinion, this method is more powerful than administrative pressure." Wang Tiehan said that this is tantamount to the General Administration "uncovering the lid" and giving local codes of conduct-otherwise, local governments and enterprises sometimes don't know, and sometimes they don't want to do it when they know.
According to the statistics of Southern Weekend reporters, since May this year, the Food and Drug Administration has released 47 pieces of public information about the Ginkgo incident.
"People are afraid of the unknown. Making the unknown public will naturally get better results. " Associate professor of National School of Administration is nonsense.
Plant extract industry scuffle
"There are many small and medium-sized enterprises in the plant extract industry, and the illegal cost is very low. This is the root cause of chaos, poor industry and illegal addition tendency." Yu Zhibin, Secretary-General of Plant Extract Branch of China Chamber of Commerce for Medicine Import and Export Health Products, said.
Due to the lack of standards and norms, some people in the plant extract industry even call this industry an "evil market".
In the investigation document of Ginkgo biloba incident published by the Food and Drug Administration, we can see such an industrial chain: Ningbo Lihua Pharmaceutical Co., Ltd., which was publicly named by the Food and Drug Administration, purchased Ginkgo biloba extract from a company without pharmaceutical production qualification, put it in storage under the label of the company, and sold it to Shenzhen Wanghai Pharmaceutical and Yang Zijiang Pharmaceutical in the name of the company.
Guilin Daxing Pharmaceutical Co., Ltd. sold its own products and products purchased from other places to Anning Branch of Yunnan Tao Xi Green Pharmaceutical Co., Ltd., a subsidiary of Kangenbei Pharmaceutical Co., Ltd., and Tao Xi sold the above Ginkgo biloba extract to Beijing Sihuan Pharmaceutical Co., Ltd. and Hunan Hansen Pharmaceutical Co., Ltd. through Kangenbei's international business department for drug production.
Kang Company revealed in the announcement that the Ginkgo biloba extract purchased by Yunnan Anning Branch came from Yunnan Baiyao Group Chinese Medicine Resources Co., Ltd. and was purchased by Yunnan Baiyao from Guilin.
It's no secret-from small companies to medium-sized companies to large enterprises, the fake and shoddy Ginkgo biloba extract produced by these small and medium-sized enterprises will eventually become the raw materials of large enterprises, become daily medicines, health care products and food consumption, and enter the mouth of consumers.
What pushes the industrial chain forward is the huge dividend brought by fraud.
Lv Zhengguang, the founder of "Planting Space" and the general manager of Guilin Pulander Biotechnology Company, has been engaged in the plant extract industry for more than ten years. He experienced the "evil" profiteering era of plant extracts in the mid-Kloc-0/1990s, when plant extracts were still a new industry, and the market price of raw materials of Ginkgo biloba extract was as high as $375/kg. However, with the increase of manufacturers around the world, this price has fallen to the bottom of 35 dollars/kg, which is less than the original price110.
The sudden shortage of resources forced the industry to enter the "Warring States Period" and enterprises "killed each other". "The industry threshold is low and the competition is fierce, which makes many companies feel that they are not making money and start to lower prices." Tu Pengfei, a professor at Peking University College of Pharmacy, said.
A manager of the purchasing department of Tianjin Jianfeng Natural Products Research and Development Co., Ltd. told Southern Weekend reporter that many plant extract manufacturers did not set up quality control departments within the company in order to save costs.
For people in the industry, the identification method of Ginkgo biloba leaves issued by the US Food and Drug Administration has long been an open secret in the industry-the identification of Ginkgo biloba leaves extract is actually very easy, and the key is that "some people need fakes" in the market now.
Southern Weekend reporter learned that the price of Ginkgo biloba extract now varies from 250,000 yuan per kilogram 140 yuan according to the degree of purification and product type, with uneven quality and different means of counterfeiting. The plant extract industry is also known as "a strange industry whose price is difficult to estimate".
Wang Lin (pseudonym) is a senior user of the "Planting Space" forum. He said that cheating in the plant extract industry "is like three meals a day, but you can't get rid of your troubles at all."
As early as the beginning of his career, Wang Lin felt the "Warring States" in the plant extract industry-he bought a kilogram of Ginkgo biloba extract with the test report of the manufacturer of Ginkgo biloba extract, and after returning to the laboratory for testing, he found that the product itself was three times different from the report.
The standard of management vacancy
The crackdown has begun. From June 5438+065438+1October 5, the State Food and Drug Administration of the United States classified Ginkgo biloba extract that was not produced according to the relevant technology as counterfeit or inferior medicine, and punished it according to the relevant provisions of the Drug Administration Law on the production and sale of counterfeit and inferior medicines.
However, in the view of some officials, many enterprises in the industrial chain of Ginkgo biloba extract have no pharmaceutical production qualification at all and have no intention of producing pharmaceutical raw materials. It is also helpless for the administrative department to punish them with the big hat of fake and inferior drugs.
Yu Zhibin, secretary-general of the Plant Extract Branch of China Chamber of Commerce for Import and Export of Medicines and Health Products, believes that it may not be the turn of the Food and Drug Administration to export Ginkgo biloba leaves: "It cannot be said that the Food and Drug Administration has hit the wrong board. If it is in China, the Food and Drug Administration has the responsibility to correct it. However, if it is exported, enterprises do not necessarily need to follow the standards of China Pharmacopoeia. "
The US Food and Drug Administration seems to be "a little too far". Yu explained that the plant extract industry rose in the 1980s and was called dietary supplement in western countries. Foreign demand gave birth to the development of plant extract industry in China. At present, in the field of plant extracts, the ratio of export to domestic sales is six to four, and most enterprises still focus on export.
In fact, in the field of plant extracts, China has always lacked a clear competent department. In the production stage, it should be supervised by the Ministry of Agriculture, but since the crops planted are obviously used as dietary supplements and medicines, it seems more reasonable to be supervised by the food and drug supervision system; In the production stage, because the raw materials produced are used in different fields, enterprises are required to obtain different qualifications in food and medicine; The US Food and Drug Administration is responsible for selling downstream plant extracts to China, and the AQSIQ is responsible for supervising the export.
Because the application field of plant extracts is too wide, food, medicine, cosmetics and so on are all involved, the direct consequence of "anyone can manage" is "no one can manage"
To make matters worse, due to the lack of clear authorities, most products in the plant extract industry have no unified production standards.
"There are four or five hundred kinds of traditional Chinese medicine extracts, plus plant extracts, I am afraid there are more than 1000 kinds, while the standard of traditional Chinese medicine extracts in China Pharmacopoeia is only 47 kinds." Yu Zhibin said that there is no standard for a large number of plant extracts.
Therefore, the plant extract industry in China has become an industry with uncertain product quality. Enterprises either borrow GMP or cGMP certification, or flaunt their uniqueness through Jewish certification and halal certification, but more small enterprises don't even set up quality management departments.
The lack of national standards forces China enterprises to use the standards of overseas customers in import and export trade, which is hindered in international trade negotiations.
This is also related to the "status" of "Made in China" plant extracts in the international market.
Tu Pengfei admits that various "hidden rules" in the domestic plant extract industry have made it lose its due reputation: "Except for a few high-end enterprises, illegal production and low-price competition have made the international reputation of the plant extract industry very poor."
"Although there are technologies and resources in China, the plant extract industry is in the upper reaches of the world industrial chain, and there are not many domestic terminal enterprises, which is the main reason for being subject to the international market." Lu said that the leading companies in setting standards are large foreign companies.
Even so, the plant extract industry is still a "sunrise industry" in China. According to the data provided by the China Chamber of Commerce for Import and Export of Medicines and Health Products, from 20 15 to September, it was 1.449 billion US dollars, with a year-on-year increase of1.48 {BF}.
The health food filing system adopted in the new Food Safety Law is also considered as one of the symbols of the excellent development of the industry. Under the policy, Zhejiang Kangenbei took the lead in increasing investment of 654.38+0.5 billion yuan to plant Ginkgo biloba for the production of Ginkgo biloba extract.
At the beginning of 20 15, Rheinland Bio announced that it would raise 500 million yuan to invest in plant extracts, and another listed company, Chen Guang Bio, invested 200 million yuan.
Industry giants are optimistic about the future market dividend of the extract industry, but more industry practitioners are still worried about market opening.
"What more people see is that the renminbi falls from the sky like ginkgo leaves." Wang Lin described the plant extract industry in his eyes like this: "There is no queue, no order. Everyone is desperately crowded under the tree, picking early, picking leaves on the tree at night, and even digging out the roots. " (Source: Southern Weekend)