Where is the loophole? Vaccine of rabies of Dalian makes the frame-up to track that investigates

Where is the loophole? Vaccine of rabies of Dalian makes the frame-up to track that investigates
Where is the loophole? Vaccine of rabies of Dalian makes the frame-up to track that investigates
Vaccine of rabies of Dalian makes the frame-up there is a new development recently: 3 persons directly responsible of products Co., Ltd. of Anderson's thing of gold harbour of Dalian adding the sour material of cores illegally are detained for criminal act by the public security organ, this illegal activities of enterprises are characterized as on purpose and make the fake by the food medicines supervision department too. When the numerous victims who has already injected vaccine of question pay close attention to the progress of details of the case, people can't help asking: What is the nuclear acid material that enterprises add on earth? To under the supervision of vaccine special medicines in the country, why make a desperate move in illegal enterprises? After enterprises close down, suspend operations, who is come to responsible for several tens of thousands of vaccine injectors' health and safety? Take these questions, " Xinhua's view point " Reporter build frame-up, go on investigation of tracking to the intersection of Dalian and the intersection of rabies and vaccine a few days ago. " mysterious " Will it be February 6 2009 such as material, national Bureau of Drugs Supervision release one Section fewer than 250 notification of word at official site their, claim Nat'l Pharmaceutical Biological Products Control Inst finds in supervising and examining to vaccine of rabies, some people of production in 2008 of products Co., Ltd. of Anderson's thing of gold harbour in Dalian of Liaoning are with the impractical material of core added illegally in detection in vaccine of rabies, the food medicines supervision department has placed on file to investigate, vaccine of question has already been controlled and recalled. At dusk on February 6, a brief circular is hung on the official site out too in Bureau of Drugs Supervision of Liaoning Province, claim " the intersection of Dalian and gold the intersection of thing and the intersection of products and Co., Ltd., Anderson of harbour, some people of production use the intersection of rabies and the intersection of core and sour material outside the the intersection of detection and composition under vaccine 2008 " . " add illegally " With " composition outside " ,No prohibition people wonder that different words: What is the sour material of these kind of core on earth? Are the behaviors of enterprises suspected of being involved in breaking the law? Reporter knows in the investigation, the sour material of these kind of core which enterprises add, in fact in order to gather afterbirth parenteral solution of skin, made up by nucleotide of many molecules. This is a listing medicines approved by national Bureau of Drugs Supervision, used mainly in the aid treatment of viral keratitis, simple bleb, chronic virus hepatitis. Dong GuanMu, researcher of Nat'l Pharmaceutical Biological Products Control Inst, introduces, as a kind of antiviral medicines, this kind of medicine began application in the seventies and eighties of last century, could be adding him to vaccine as adjuvant to use research if there are experts at presenting, animal's test proves that adds it after vaccine as adjuvant, there is a result of very good improvement vaccine, what a question it is but the effective, security to the human body, also remain to assess and appraise in the research in the future. "To enterprise, so long as has not produced according to the production technology for producing official written reply and approval, it is a kind of illegal activities to add the sour material of cores without authorization, we will deal with enterprises strictly. " The attitude when being interviewed by reporter of Yan JiangYing, press spokesman of national Bureau of Drugs Supervision is clear. According to the present investigation, gold harbour Anderson thing products Co., Ltd. of Dalian will produce 97 groups of people and use vaccine of rabies in 2008, amount to the shares of 3,389,000 people, through criticizing issuing and permitting selling 83 batches, amount to the shares of 2,953,200 people. In 83 batches appearing in sale, 11 batches freeze and be people and use vaccine of rabies, are added the material illegally by detection, it is the shares of 360,200 people altogether. The reporter knows from the police in Dalian, what enterprises add illegally gathers the skin afterbirth the legal representative of this enterprise of parenteral solution department, general manager Wang QuanFeng instigate the purchasing agent to manage enterprises to buy from of medicines of Shenyang, it is No. 1600 Branch altogether, each 2, its refered to add reason of medicine this, to " add, gather the intersection of skin and the intersection of afterbirth and parenteral solution, can make user produce antibody early " . But the insider points out, enterprises add the illegal material and is actually driven by the interests. Register the biologicals Yin HongZhang, division chief of introduction of the department according to medicines of national Bureau of Drugs Supervision, can strengthen the human response to antigen while adding into vaccine and gathering afterbirth parenteral solution of skin, can make enterprises save the antigen while producing in vaccine, it is enterprises that reduce the production cost of 1/3 even over half. "That is to say that can only produce the antigen of a piece of vaccine originallied, now can be used for producing two. " Where is loophole according to the stipulations of country, vaccine products must belong to through national mandatory examination, examine and approve for merchandizing criticize and issuing the products, but the delivery inspection index of the check organization hits and excludes the sour composition of cores, after national Bureau of Drugs Supervision receives reporting of the offence to know enterprises add the illegal material in vaccine, while making the sour composition supplementary inspection of cores to product, have just found this question, does this series of course prove the medicines supervision department exist and slip? The persons in charge of related departments of national Bureau of Drugs Supervision explain, according to relevant regulations, enterprises must use the material sanctioned being can be used, and produce according to the craft sanctioned, and nuclear all kinds of acid and material use without approval, is not listed in the delivery inspection index of the check organization. The reporter knows in the interview, because it is relevant to receive and report, between November and the beginning of 2008, national Bureau of Drugs Supervision has launched the vaccine special renovation action of of rabies in the whole country, find event definitely by division, have increased the sour material of cores to measure to all vaccine manufacturing enterprises in the whole country, but not found the impractical material of cores when inspected to the products of Anderson thing products Co., Ltd. of gold harbour of Dalian by random samples at that time. "Once the game which enterprises and the supervision department played, it is really very difficult for the supervision department to reply. " Our country has manufacturing enterprises of 34 of vaccine, 13 vaccine manufacturing enterprises of rabies among them at present, the total amount for producing enterprise of vaccine of our country is nearly equivalent to the total that vaccine produces number of the enterprise besides China of the whole world. The fierce market competition impels some enterprises not to hesitate to make a desperate move in order to chase profits, thus has supervised and proposed more severe challenge to the government. But the reporter notices in the interview, when a lot of people are mentioning vaccine of rabies of Dalian make the frame-up, think the medicines supervision department discovers the problems and relatively lags behind. Medicines supervision departments at all levels, should review and improve existing system defect and system loophole. The relevant behavioral punishment efforts to fake production of medicine of laws and regulations in our country is relatively light at present, also encouraged the ideas of leaving things to chance of illegal enterprises objectively. According to the current law of medicine management in our country, Bureau of Drugs Supervision of Dalian punished the illegal activities of gold harbour Anderson thing products Co., Ltd. of Dalian a few days ago: Confiscate medicines and unlawful gains produced, sold illegally, and fine 3 times of the goods value amount of money involved in the case; The person directly responsible of place can't be engaged in the medicines production and operating activities in 10 years; Submit to " medicines production licence " which revokes this company The insider points out, according to international practice, engaged in producing, selling the enterprises or direct persons in charge of false medicine of a serious nature and can't be engaged in medicines production all the lifing, business activities, the intersection of penalty and even amount of money It is much higher than our country. Our current punishment to medicines enterprise's illegal activities of laws and regulations, it is not enough to let counterfeiters draw the lesson. Reviewing the vaccine incident of making the fake, the insider points out, our country is while further strengthening supervision of medicines, also should revise the relevant laws and regulations as soon as possible, raise the illegal cost of enterprises by a wide margin, use " high-handed policy " Guarantee enterprises are more normal in production, ensure the life and health of common people and use medicine safely conscientiously. Meet an urgent need, respond to the intersection of Dalian and the intersection of rabies and vaccine build frame-up, reveal, national Bureau of Drugs Supervision and Liaoning Province, Dalian municipal government and medicine supervise the department make, meet an urgent need, respond to, including launching illegal vaccine investigation and control, monitoring and arresting suspects, treatment enterprise to stop the postpartum, assets and worker are found a room for immediatelying etc., and recall question medicines. Help and fit director Li Ning to point out in Beijing, the dosage needing suring that vaccine of rabies contributes, add the material and certainly will exert an influence on the immune result of vaccine illegally. We can say, it is possible to have illness coming on for all patients who has injected vaccine of this question, have illness coming on and position that patient is bite blood circulation abundant biting intensity and wound deal with situation, health of patient,etc. have relation. The reporter learns in the interview, Ministry of Public Health had already given notice to all parts a few days ago, require vaccine to not recalling yet, once find that there are patients who has already used and not produced the consequence, reseed the rabies vaccine that other companies produced in time, find the side effect should be dealt with in time, all expenses are listed and prop up by the state finance. (XinHua daily dispatch reporter Cui support the army by XingYu, Cai by Jing, Fu)


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