蒲公英 - 制药技术的传播者 GMP理论的实践者

搜索
查看: 805|回复: 0
收起左侧

[行业动态] 印度针对于缬沙坦进行调查,但暂未实施召回行动

[复制链接]
药士
发表于 2018-7-20 21:13:50 | 显示全部楼层 |阅读模式

欢迎您注册蒲公英

您需要 登录 才可以下载或查看,没有帐号?立即注册

x
本帖最后由 beiwei5du 于 2018-7-20 21:16 编辑

India launches probe as Chinese company recalls BP drug
Updated: Jul 20, 2018, 04.52 PM IST


India’s drug controller has initiated an investigation on Thursday against all companies importing key raw material valsartan for commonly used hypertension drugs from Chinese manufacturer
Zhejiang Huahai Pharmaceuticals.

This comes in the wake of recall of medicines containing valsartan in several developed countries recently, including the US, Germany and Italy after reports that an ingredient used in valsartin’s manufacturing by this particular company carries “potential cancer risk”.

Both the importer and the Chinese manufacturer, Zhejiang Huahai Pharmaceuticals, will be issued a show-cause notice soon.

Valsartan medicines are used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke.

Regulatory agencies, including US Food and Drug Administration and European Medicines Agency, started a review of medicines containing the active substance valsartan.

However, even as the review is underway, national authorities across the EU are recalling medicines containing valsartan supplied by Zhejiang Huahai.

Certain companies in the US are also voluntarily pulling out the drug from the market. Hypertension is one of the most common lifestyle diseases in India, with one in three adults with high blood pressure.

“All port offices are being issued orders to check each consignment being imported into the country, and send each batch for testing the key input in our labs”, DGCI S Eswara Reddy told TOI, ruling out a recall as yet.

There would be a recall only if evidence is established; we do not want to create panic (among patients), he said.

The Central Drugs Standard Control Organisation swung into action on Thursday after it found that Zhejiang Huahai was registered with it.

Typically, the import is carried out by an importer who may also appoint agents for importing the product. The probe will cover all agents who hold the licence for the API, and all quantities imported into the country, the official said.


(This article was originally published in The Times of India)
回复

使用道具 举报

您需要登录后才可以回帖 登录 | 立即注册

本版积分规则

×发帖声明
1、本站为技术交流论坛,发帖的内容具有互动属性。您在本站发布的内容:
①在无人回复的情况下,可以通过自助删帖功能随时删除(自助删帖功能关闭期间,可以联系管理员微信:8542508 处理。)
②在有人回复和讨论的情况下,主题帖和回复内容已构成一个不可分割的整体,您将不能直接删除该帖。
2、禁止发布任何涉政、涉黄赌毒及其他违反国家相关法律、法规、及本站版规的内容,详情请参阅《蒲公英论坛总版规》。
3、您在本站发表、转载的任何作品仅代表您个人观点,不代表本站观点。不要盗用有版权要求的作品,转贴请注明来源,否则文责自负。
4、请认真阅读上述条款,您发帖即代表接受上述条款。

QQ|手机版|蒲公英|ouryao|蒲公英 ( (京)-非经营性-2014-0058 京ICP证150354号 京ICP备14042168号-1 )

GMT+8, 2024-3-29 23:27

Powered by Discuz! X3.4运维单位:苏州豚鼠科技有限公司

Copyright © 2001-2020, Tencent Cloud.

声明:蒲公英网站所涉及的原创文章、文字内容、视频图片及首发资料,版权归作者及蒲公英网站所有,转载要在显著位置标明来源“蒲公英”;禁止任何形式的商业用途。违反上述声明的,本站及作者将追究法律责任。
快速回复 返回顶部 返回列表