2019年FDA警告信分析，美国、印度成最大输家

据统计，2019年FDA发出的警告信中，美国和印度占据了总数的第一和第二。美国占40%，而印度占34%。

公共健康活动家Dinesh S Thakur评论说，“这一切都归结于利润，和对削减开支的监督不力，以及对患者缺乏任何责任。”

美国议会委员会的报告中写道“困扰印度药品监管体系的大部分弊病主要是由于印度中央药品标准控制组织（CDSCO）扭曲的优先级和价值观”。“几十年来，他们一直以制药企业的扩展和便利为首要地位，不幸的是，最大的利益相关者，即消费者的利益从未得到保障。”

报道如下：


Areport has found that of the 38 warnings handedout to pharmaceutical companies by the US Food and Drug Administration (FDA)in 2019, 13 were to Indian companies and 15 were to American businesses. DownToEarth haveshown that warnings to US drug makers make up 40 percent of the total issuesfound by the regulatory body whereas the warnings to Indian companies stand at34 percent.
一份报告显示，在2019年FDA向制药公司发出的38项警告中，13个警告是发给印度公司的，15个是发给美国药厂的。DownToEarth显示，对美国制药商的警告信占FDA发现的总问题的40%，而对印度公司的警告信占34%。
 
Repeat offenders
重复违规

"It all boils down toprofits and the fact that there is inadequate oversight of cutting corners andlack of any accountability towards patients who consume these so-calledmedicines,” Thakur told DTE.
Thakur告诉DTE，"这一切都归结于利润，和对削减开支的监督不力，以及对患者缺乏任何责任。
 
“Most of the illsbesetting the system of drugs regulation in India are mainly due to the skewedpriorities and perceptions of Central Drugs Standard Control Organisation(CDSCO)," read the 59th Parliamentary Committee report.
美国议会委员会的报告中写道"困扰印度药品监管体系的大部分弊病主要是由于印度中央药品标准控制组织（CDSCO）扭曲的优先级和价值观"。
 
"For decades togetherit has been according primacy to the propagation and facilitation of thedrugs industry, due to which, unfortunately, the interest of the biggeststakeholder i.e. the consumer has never been ensured,” it added.
"几十年来，他们一直以制药企业的扩展和便利为首要地位，不幸的是，最大的利益相关者，即消费者的利益从未得到保障，"他补充道。
 
Moreover, the contents ofthe warning letters bring out certain patterns of violations indicatingindustry-wide problems.
此外，警告信的内容也包括一些违规形式，表明整个行业的问题。
 
Quality control
质量控制

Seven of the 13 companieswere pulled up for having inefficient quality control units. The warningletters stated that quality control units in B Jain Pharma, Strides Pharma andGlint Cosmetics either did not provide adequate oversight or lacked appropriatecontrol over quality testing of products.
13家公司中有7家因质量控制单位失效。警告信指出，B Jain制药、斯捷特制药和Glint化妆品的质量控制单位要么没有提供足够的监督，要么对产品质量测试缺乏适当的控制。

In the case of Stridespharma, the inspectors found evidence of uncontrolled shredding of documentsand discarded CGMP documents, some of which were just seven days old.
就Sthes的制药厂而言，检查人员发现了文件的粉碎不受控的证据和丢弃的CGMP文件，其中一些文件是检查前7天的。
 
The FDA inspectors alsofound that Rxhomeo had not tested incoming materials for quality and JubilantGenerics had not conformed to appropriate testing procedures in productionprocess. Indoco’s and Anicare Pharma’s quality control units were found to beinadequate too.
FDA检查人员还发现，Rxhomeo没有对进厂物料进行质量测试，而JubilantGenerics在生产过程中未遵循适当的测试程序。Indoco’s和Anicare Pharma的质量控制单位也存在不足。
 
API contamination
API污染
 
Maintenance oversight withrespect to active pharmaceutical ingredient (API) contamination was a recurringcharge against all three API manufacturers — Lantech Pharmaceuticals Ltd,Aurobindo Pharma and Vipor Chemicals Pvt Ltd.
对于兰泰克制药有限公司、奥罗宾多制药和Vipor 化学品有限公司，发现了活性药物成分（API）污染维护监督重复性缺陷。
 
The USFDA letter to Viporhighlighted its “failure in establishing and following adequate writtenprocedures for cleaning equipment and release for use in the manufacture ofAPI”.
FDA对Vipor的警告信中强调，他们"未能建立并遵循适当的书面程序，以清洁设备并放行以用于制造API"。
 
Lantech was also found tohave followed inadequate cleaning procedures. According to the warning letterto Aurobindo, it had “failed to ensure that equipment surfaces in contact withAPI do not alter the quality of the API beyond the official or otherestablished specifications”.
兰泰克也被发现遵循了不适当的清洁程序。根据Aurobindo的警告信，它"未能确保与API接触的设备表面不会使API的质量超出官方的或其他既定标准"。
 
Data integrity
数据完整性
 
The FDA found that HospiraHealthcare, Centurion Laboratories and Indoco Remedies didn’t maintainlaboratory records properly.
FDA发现，辉瑞Hospira、Centurion实验室和Indoco Remedies没有正确保存实验室记录。
 
It was also observed thatGlint Cosmetics and Rxhomeo didn’t have proper control to ensure that onlyauthorised personnel instituted changes in master production and controlrecords. Strides Pharmaceuticals was also asked to remedy their data managementtechniques for better compliance with FDA standards.
还观察到，Glint化妆品和 Rxhomeo 没有适当的控制以确保只有经授权的人员才可对主生产和控制记录进行更改。此外，为了更好地遵守FDA标准，Strides制药公司也被要求对其数据管理技术进行补救。
 
Cleanliness
清洁
 
FDA inspectors learnt thatCenturion and Anicare Pharma had failed to “follow written procedures forcleaning and maintenance of equipment”. B Jain Pharma had also failed to cleanand maintain appropriate sanitation and it didn’t sterilise equipment andutensils at appropriate intervals.
FDA检查员发现，Centurion和Anicare制药公司没有"遵循设备清洁和维护的书面程序"。B Jain Pharma 也未能清洁和维护适当的卫生设施，也没有在适当的时间间隔对设备和器具进行消毒。
 

Even though the share ofFDA warning letters to Indian BioPharma companies has shrunk, the industry hasa long way to go.
尽管FDA给印度生物制药公司的警告信所占的份额已经缩小，但该行业还有很长的路要走。

       文章来源： GMP办公室

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