news:China May Blacklist Unsavory Capsule Makers

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            China May Blacklist Unsavory Capsule Makers         Make a comment               

By Ed Silverman // June 1st, 2012 // 8:25 am

        In the wake of a controversy over unsafe capsules in China, the State Food and Drug Administration may blacklist some pharmaceutical manufacturers. The move is seen as an effort to restore a degree of public confidence after the SFDA conducted a month-long probe and found that 254 pharmaceutical companies, or 12.7 percent of all capsule makers, turned out capsules containing unsafe levels of chromium (back story).
The investigation, however, was begun only after local media uncovered the problem. And so the SFDA is floating the blacklist proposal and soliciting public comments until next Wednesday, according to China Daily. The blacklist will contain companies and people that “severely” violate safety rules in manufacturing and selling medicine and medical equipment  (here is the SFDA statement).
Those who make or sell fake or substandard medicine, forge materials to apply for licenses, and produce medical equipment without credentials may be put on the list, according to the proposal. The blacklist will be made available through government websites and media releases. The SFDA will be in charge of monitoring behavior as supervisors will be tasked with inspecting companies on the list more often and demanding periodic quality management reports.
The idea is to ensure drug safety, deter violations and build a system to track drugmakers, the China Daily writes. One expert believes this may work. “If blacklisted, a company will lose its reputation and that will deal a heavy blow to sales. The cost of violating the rules will increase significantly,” Sun Zhongshi of the National Rational Drug Use Monitoring System, which operates under the Ministry of Health, tells the paper. “It’s important to determine a period of validity for the blacklist. Those who continue with their bad practices should be expelled from the trade forever.”
So far, Chinese authorities have investigated 236 capsule makers and ordered 42 to halt production, closed down 84 production lines, revoked production licenses of seven companies and referred 13 to the police. Of the 11,561 batches of drugs tested, 5.8 percent were found to contain excessive levels of chromium, according to the SFDA (here is SFDA statement on its investigation).
Meanwhile, one manufacturer confessed to distributing capsules with high levels of chromium, but maintains steps are being taken to avoid a repeat. Biostar Pharmaceuticals acknowledged that the SFDA found excessive chromium levels in samples of 1.2 million capsules its Xin Aoxing Oleanolic Acid Capsule, an over-the-counter treatment for hepatitis B. Its own examination then found the same thing in samples from another batch containing 2.7 million capsules.
How did this happen? Biostar blamed the initial problem on a former employee who last year bought 4 million capsules from an unapproved supplier. The former manager was fired last August, although Biostar acknowledged that tests were not conducted, the drugmaker maintains testing was not required at the time. The drugmaker is now testing all capsules purchased since last June and has additional testing equipment and quality-control procedures in place. Biostar adds its capsules now come from food-grade gel.
“We intend to announce the results of this self-administered inspection in middle of June, when Xianyang SFDA, in turn, reviews and approves the conclusions of our inspection,” Biostar ceo Ronghua Wang says in a statement. “…While we believe that our quality control and purchasing practices are adequately suited to address our needs, we have been and remain fully committed to complying with all applicable SFDA directives as well as bolstering our internal quality assurance measures. We have invested in additional testing equipment, and increased the frequency and depth of our self-administered inspections of our inventory and supplies.”

   

StephenW

中国可能黑名单令人讨厌的胶囊庄家
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埃德西尔弗曼/ / 6月1日，2012 / / 8:25上午

在一个对不安全胶囊在中国的争论之后，国家食品药品监督管理局可能列入黑名单，一些药品生产企业。此举被看作是为了恢复市民的信心度后，国家食品药品监督管理局进行了长达一个月的调查，发现254个制药公司，或12.7％，所有胶囊制造商横空出世胶囊含铬的不安全水平（后面的故事） 。

的调查，然而，当地媒体开始后，才发现了问题。等国家药监局漂浮黑名单的建议，并征求公众意见，直到下周三，据“中国日报”。黑名单将包含公司和人民的“严重”违反安全规则，在生产和销售药品和医疗器械（在这里是国家药监局的声明）。

或出售伪劣药品，伪造材料申请牌照，并产生医疗设备，没有凭据可放在名单上，根据这项建议。黑名单将可通过政府网站和媒体发布。国家食品药品监督管理局将负责监测行为，作为主管将负责检查名单上的公司更经常地，并要求定期质量管理报告。

我们的想法是，以确保药物的安全性，阻止侵犯人权的行为，并建立一个系统来跟踪制药公司，“中国日报”写道。一位专家认为，这可能会工作。 “如果被列入黑名单，该公司将失去其声誉和销售，这将造成沉重的打击。违反规则的成本将显着增加，“太阳的全国合理用药监测系统，根据卫生部运行，陈忠实告诉纸张。 “这是非常重要的决定的有效期为黑名单。那些继续用自己的陋习，应该从贸易永远被驱逐。“

到目前为止，中国当局已调查236胶囊制造商，并下令42停止生产，关闭84条生产线，7家公司被撤销生产许可证，并提及13日向警方。 5.8％的测试药物的11561批次，被发现含有过量的铬，根据国家食品药品监督管理局（这里是国家食品药品监督管理局在其调查的声明）。

与此同时，一个制造商承认分发胶囊铬高层次，但保持正采取步骤，以避免重复。映泰制药承认，国家食品药品监督管理局发现1.2亿粒胶囊的新奥星齐墩果酸胶囊，治疗B型肝炎它自己检查过的柜台样品中的铬含量超标，那么从另一个含有270万批次的样品中发现了同样的事情胶囊。

这是怎么回事？映泰最初的问题归咎于前任雇员，去年买了4亿粒胶囊，从未经批准的供应商。前任经理被解雇去年八月，虽然映泰承认，没有进行测试，的制药维护测试所需的时间。的制药公司正在测试自去年6月以来购买的所有胶囊，并有额外的测试设备和质量控制程序到位。映泰增加了它的胶囊，现在从食品级的凝胶。