More than a year of “ginkgo leaf storm” has finally come to an end. Published by the state food and drug supervision and administration bureau of illegal production and sales of ginkgo biloba extract and preparation of the processing results of the enterprise, plant extract 65 involved drug firms are respectively given to revoke the pharmaceutical production license, cancel the drug approval documents, fine warning, submit to the local government to shut down, such as punishment, fines total one hundred million yuan
Since may of last year, the state drug administration in the nationwide ginkgo biloba extract and preparation of special management action, 90 use of ginkgo biloba extract as raw materials for the pharmaceutical drug manufacturing enterprise was ordered to self-check. After investigation, for producing fake medicines and medicines of inferior quality of enterprise 59 were punished in accordance with the law. Among them,plant extract the pharmaceutical production license have been revoked four; Quasi revoked drug approval documents four; Fines and other administrative penalties 47, FaMeiKuan total amount is 103 million yuan; Without drug manufacturing certificate were submitted to the local government to shut down four enterprises. The enterprise, the alleged crime was transferred to public security organs eight; Was sentenced to ten plant extract years shall not be engaged in drug production and business activities with qualifications punishment responsibility seven; Be free from 6 or no administrative punishment.
Involved in the pharmaceutical production enterprise in our province, a total of four, respectively is: pharmaceutical co., LTD. Shandong plant extract double China outsourcing enterprise production of ginkgo biloba extract, without qualification to stick a card after foreign sales, the formulation of downstream enterprise production caused by medicines was identified as fake medicines and medicines of inferior quality, illegal if the circumstances are serious, the drug production licenses have been revoked concurrently impose a fine. Yantai rongchang pharmaceutical co., LTD., southern shandong plant extract pharmaceutical co., LTD., shandong grass bouquet thick tome pharmaceutical co., LTD., illegal production JiaLie ginkgo biloba preparations,plant extract by local food and drug regulatory authorities to impose a products and illegal income, confiscate the illegal fines and other administrative penalties.
Replace plant extract dilute ethylene with dilute hydrochloric acid extract ginkgo biloba is one of the major problems found in the national examination. “Dilute hydrochloric acid preparation of ginkgo biloba extract can reduce costs 3000 yuan, 3000 yuan per ton, and yield rate will be increased significantly.” A drug companies in our province, said an official with the production department in order to reduce costs, improve efficiency, this kind of “process” became the “hidden rules” of ginkgo biloba extract industry. And by the dilute hydrochloric acid extract of ginkgo biloba extract effective components is reduced,plant extract the harmful material such as ginkgo acid content increased, greatly influenced the effect and safety of the product.
Ginkgo biloba extract mess behind is the lack of industry standards. plant extract Zhuo and information industry analyst zhang bin said that Chinese traditional medicine is different from traditional Chinese medicine raw materials, slices of industry standards and industry standards, plant extracts is no clear industry standard, the ginkgo biloba extract, pharmacopoeia referred to in the production specification, test standards require only a guiding outline, plant extract to guide and standardize the restriction to the enterprise production. “Due to lack of industry standards, enterprise production level is uneven, circulation order, restrict the development of the industry.”
It is understood that at present, including ginkgo biloba extract, plant extract industry industry standard is worked out, this or become a “ginkgo leaf storm” to industry.