The regulation is heating up, and the "debt" of the whole industry chain of extract has expired

[zhongyaopu] as the State Food and Drug Administration continuously issued a circular to disclose the investigation process of illegal Ginkgo biloba extract, the Pandora box about the risk of extract also opened The self inspection results of 90 pharmaceutical companies on ginkgo leaf products released by the State Food and Drug Administration's website are amazing The results showed that among 90 Ginkgo biloba leaf extract, Ginkgo biloba leaf (including dispersible tablets) and Ginkgo biloba leaf capsule manufacturing enterprises, 55 enterprises were found to be involved in unqualified Ginkgo biloba leaf products, among which 30 enterprises were found to be unqualified in all batches through self inspection, and the total batch of unqualified products was 2335, accounting for 45% of all self inspection batches Then the list of 21 enterprises involved in illegal Ginkgo biloba extract health products was exposed, which showed the potential of the spread of Ginkgo biloba extract in the pharmaceutical and health industry chain It is clear that the seriousness of the problem has exceeded the expectations of all parties in society The author believes that the "debt" of the whole industrial chain of the extract initiated by and exposed by the problem of Ginkgo biloba extract has expired No matter other extract enterprises or downstream medical and health care enterprises, if they still think that the place where the "fire" can burn is a small piece of Ginkgo biloba extract, they also think that even if the "fire" is burned, it can "spring wind blows again and again" in a short time, That's a big miscalculation of the situation First of all, the emergence of the problem extract is actually an economic account, while the economic account based on the interests of consumers is unsustainable For example, the cost of hydrochloric acid is much cheaper than that of dilute ethanol, and the price is about one sixth of that of dilute ethanol According to some experts, the price of gingko leaves produced by legal extract is 1.7 yuan per tablet, but the price of finished products produced by illegal gingko leaves extract is only 1.1 yuan per tablet The huge profits can be imagined Enterprises in the industry chain of Ginkgo biloba leaves have forgotten the minimum commitment to consumers' medication and health care, that is, the safety of products Changing the extraction process of Ginkgo biloba leaves from ethanol extraction to 3% hydrochloric acid extraction has a clear impact on safety: on the one hand, illegal Ginkgo biloba leaves extract can decompose the effective ingredients of drugs and affect the efficacy of drugs; on the other hand, in the view of some experts, the chemical ingredients of Ginkgo biloba leaves extract contain the harmful ingredient of ginkgo acid, which can cause serious allergic reactions; on the other hand, it can cause serious allergic reactions May cause gene mutation, nerve damage, etc In view of this, both the Pharmacopoeia of China and the United States have requirements for the content of ginkgolic acid According to the current Pharmacopoeia of 2010, the content of ginkgolic acid in Ginkgo biloba preparation should be less than 10 UG / g If hydrochloric acid extraction method is used, the content of ginkgolic acid may exceed the standard Secondly, it should be noted that the food and drug administration has expanded its field of vision to investigate and deal with problematic extracts in the field of animal extracts after discovering the disorder of Ginkgo biloba extract According to the notice disclosed by the State Food and drug administration, after discovering that Wuhan Hualong biopharmaceutical Co., Ltd illegally produces calf blood deproteinized extract injection, the administration has required the food and Drug Administration of each province (District, city) to organize forces to carry out a comprehensive inspection on the biochemical drug production enterprises in its administrative region, and the inspection situation needs to be reported before June 30 From this point of view, the regulatory side has realized where the previous regulatory loopholes are, and is making every effort to "fill in the loopholes" In this case, the author believes that in the past, only pay attention to whether the effective ingredients of drugs are up to the standard, and ignore the harmful ingredients, or the regulatory means that do not require mandatory testing should be actively eliminated Finally, the Pharmacopoeia closely related to the extract is about to be upgraded On June 5, the State Food and Drug Administration officially promulgated the Pharmacopoeia of the people's Republic of China 2015 edition, which will be officially implemented from December 1 A great progress of the new edition of pharmacopoeia is to further expand the application of advanced and mature detection technology, and focus on strengthening the control requirements for the safety and effectiveness of drugs The author believes that every enterprise in the extractive industry chain should make good use of the expectation of the State Food and Drug Administration on the new edition of the Pharmacopoeia, that is, the new edition of the State Pharmacopoeia will play a role of "protective wall" to ensure the safety and effectiveness of drug use, play a role of "Navigator" to lead the adjustment of industrial structure and the upgrading of product quality, play a role of "booster" to enhance the competitiveness of enterprises, and It plays the role of "Rainbow Bridge" for Chinese pharmaceutical to realize the hard commitment of quality and lead to the road of internationalization.