India issues Guidelines for Certification of API Exports to EU

GmpForEver

India issues Guidelines for Certification of API Exports to EU - can the EU accept this Certification? After the announcement from India that the Central Drugs Standards Control Organization (CDSCO) would be the competent authority to issue written confirmations as required by the Falsified Medicines Directive for importing APIs into the European Union, all eyes were on the Indian Regulator to announce the procedure for issuance of such certification. The Indian regulator has now published documents on its website. These documents give administrative procedure to be followed by manufacturers and the CDSCO. However it is surprising that both the Indian "Drugs and Cosmetics Act" and the Indian "Drugs and Cosmetics Rules" do not have any provision for issuance of a guidance document. But these documents have been published as guidelines and SOPs. So some questions might be asked: how do these documents become a statute or a regulation or a standard? And are they an enforcement tool or do they have any legislative sanction and legal status? The standard for GMPs has remained unchanged and this standard is not equivalent to ICH Q7 or Part 2 of the EU-GMP Guide. India has a federal structure with each state having its own local Food and Drugs administration who issue the manufacturing license for the manufacture of an API. The inspectors of these local offices have the legal authority to inspect the manufacturing premises and not the CDSCO, which is a Central Authority. So now there is a somehow paradox situation where the standards for GMP are national Indian Standards enforced by the state/provincial Indian FDA and there is a Written Confirmation issued by CDSCO as a central agency with no enforcement authority and no oversight of GMP implementation. Uday Shetty points out that India first needs to have a Regulatory Standard in place which is equivalent to the EU standard and than have an effective enforcement practice in place. Once this is realised, a Written Confirmation can be issued. He thinks that Written Confirmations can not be given until GMP standards and enforcement are really equivalent to those in the EU. For this India needs to change its statutes, modify the GMP regulations in the Indian Drugs and Cosmetics Act and rules to incorporate the GMP requirements of ICH Q7 and introduce regulatory and/or legislative measures for effective  enforcement of GMPs before a legally valid certification required by EU Directive can be issued.

雪锋

印度问题的API出口欧盟认证指南可以欧盟接受此证书吗？

雪锋

印度宣布，中央药品标准控制组织（卫生部下设）将发出书面确认所伪造的药品进口原料药的指令为欧盟主管机关，所有的眼睛都在印度监管机构宣布发行等认证程序。印度监管机构已在其网站上公布的文件。这些文件给行政程序应遵循的制造商和卫生部下设。然而令人惊讶的是，印度药品和化妆品法案》和印度药品和化妆品的规则”，没有一个指导性文件发行的任何规定。但这些文件已公布的指导方针和标准操作规程。因此有些问题可能会问：如何将这些文件成为一个法律或法规或标准？和他们的执法工具或他们有法律制裁和法律地位？对于GMP标准保持不变，这个标准是不等价的EU-GMP引导部分ICH Q7或2。印度有一个联邦结构的每个国家有它自己的本地食品和药物管理局颁发的API生产制造许可证。这些当地办事处的人员有权检查制造场所及不卫生部下设的，这是一个中央的权威。所以现在有一种莫名其妙的悖论在GMP标准是国家印度标准/省印度FDA并有书面确认的卫生部下设作为一个没有执法机构和无监督实施GMP的中央机构执行的状态。乌代Shetty指出印度首先需要有一个监管标准到位，这相当于欧盟的标准，比有一个有效的执法实践。这是一次意识到，可发出书面确认。他认为书面确认不能考虑到GMP标准和执行是相当于欧盟。为此印度需要改变它的法规，修改在印度药品和化妆品法案和规则的GMP法规将ICH Q7 GMP要求，并介绍GMP的有效实施监管和/或立法措施在合法有效的认证由欧盟指令要求可以发出。

雪锋

俺英语不好，用百度翻译的。要不容易当成广告处理的。

雪锋

这个也没怎么关注过。

love_fo

我反复看了多遍，好帖，得支持












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小草

这是什么东西

强叶炜

回帖是必须的，这个可以有！