印度多家药厂GMP符合性无法保障

India under Pressure: GMP Conformity Not Guaranteed in many APIs Facilities

印度法规压力：很多药厂GMP符合性无法保障

The pressure on India is getting bigger because of GMP deficiencies found during inspections. A wide range of FDA Warning Letters and FDA Import Alerts are given special attention. The GMP deviations observed are extreme and partly alarming with regard to the potential risks for the patients. Even elementary GMP requirements have been neglected. Production areas were often found in an uncontrolled status (risk of cross contamination) that medicinal products had to be recalled. The Warning Letter for Wockhardt is one of the most prominent examples. According to an article published in RAPS Online, FDA inspectors wrote in this letter about the location: "a wide range of disturbing allegations, including bathrooms that allowed for the collection of standing urine on floors, products contaminated with glass and unknown "black particles," staff that repeatedly lied to FDA on multiple occasions, and manufacturing lines that were kept hidden from investigators."

印度的制药行业在GMP检查中，发现多次GMP缺陷，显示其法规压力越来越大，特别引人注意的是FDA向印度制药企业发出大面积警告信并实施进口禁令。在检查中所发现的缺陷警示着可能对患者产生的潜在风险，有些企业甚至无视基本的GMP要求。经常发现生产区域处于不受控的状态（交叉污染风险），不得不将药品进行召回。WOCKHARDT的警告信即是最有代表性的例子。根据RAPS ONLINE上发表的文章，FDA检查员在其关于该被检查场所的警告信中写道：“许多令人不安的指控，包括淋浴室地板上的小便，药品被玻璃污染，并发现未知“黑色颗粒”，员工在多个场合一直对FDA检查官撒谎，将生产线隐匿不让检查官发现”。

At the same time, this shows that effective and extensive GMP monitoring in India is inexistent. An article of the news agency Reuters summarised impressive information on the topic. According to it, 1,500 inspectors are responsible for 10,000 factories. In one out of every 22 samples, lack of quality has been observed. These data come from a study already performed two years ago.

同时，许多情况表明在印度并没有实施广泛有效的GMP监控。一篇路透社新闻关于此话题的综述资料令人印象深刻。根据该新闻，来自2年前的一份研究数据表明，1500名检查官负责监控10000家工厂，发现每22个样品中就有1个不符合质量要求。

Reuters refers to industry analysts who say that companies which cannot deliver into the USA because of an Import Alert might continue their production and sell their products to other countries which are not aware of those GMP deficiencies. This is a terrifying scenario which is - according to experts' statements - current practice in India. Such serious problems can only be explained because of totally insufficient monitoring of medicinal products in India. A GMP inspector in India told Reuters: "I took salaries for 30 years without doing anything. I visited some of the plants ... not with the intention of taking any action, but just out of curiosity." Reuters quotes an employee of India's health ministry who says that only the US FDA complains about Indian factories. "(...) other countries have no problems with our drugs. They have never raised any objections or have found fault," This statement can be easily refuted. The EudraGMDP database currently lists 38 facilities in India which have been classified as "GMP non-compliant" because of negative GMP inspections.

路透社引用企业分析人员的话说，公司由于进口禁令无法向美国发货，他们可能会继续生产，将产品销售至其它不知道这些GMP缺陷的国家。根据专家的说法，这种恐怖的做法目前是印度通行的做法。这样严重的问题有一个原因：印度的药品完全脱离了监管。一个印度的检查官告诉路透社：“我拿了30年工资，其实什么都没做。我去一些工厂……并没有准备采取任何措施，只是出于好奇。”路透社引用一位印度卫生部的雇员的话说，只有美国FDA不满意印度的工厂，“……其它国家对我们药都没有提出问题。他们从来没有拒绝过我们的产品，也没有发现缺陷”。这种说法完全站不住脚。在欧盟GMDP数据库中，目前有38家印度工厂因为GMP检查结果不好，被列为“GMP不符合”。

The lack of adequate GMP supervision (GMP Inspections) by Indian Authorities also raises questions on the EU procedure to require Written (GMP) Confirmations from agencies around the world. In order to import an API from a manufacturer located outside the EU the legal provisions require that a Written Confirmation has to be issued by the exporting countries (only some countries like e.g. Switzerland, USA have been found to have equivalent GMP Inspection systems and do not need to issue Written Confirmations). India has published many Written Confirmations for API manufacturers in India. However, some of the companies who own a Written Confirmation received FDA Warning Letters or EU GMP non-compliance statements only some months after the Written Confirmations were issued. This questions the value of the Written Confirmations also for all other facilities in India not inspected recently by EU or FDA inspectors. The information published by Reuters, RAPS Online and other well recognized media sources may require to initiate additional actions by industry and regulators in the EU in order to safeguard APIs imported from India.

由于印度药监当局对GMP监管不足，还引发了EU要求世界各国药监当局出具书面证明程序上的问题。要将原料药从非欧盟产品出口至欧盟，根据法规条款，生产国药监当局需要签发一份书面证明（只有一些国家，如瑞士、美国由于其GMP检查体系与欧盟相当而不需要签发书面证明），印度为其国家的原料药生产商签发了许多书面证明。但是，很多持有书面证明的公司却在书面证明签发后仅几个月即收到了FDA的警告信，或EU GMP不符合申明。这使得其它在近期未被欧盟或FDA检查的印度工厂所持有的书面证明的价值受到了质疑。根据路透社信息，RAPS ONLINE和其它影响力较大的媒体可能会要求欧盟制药行业和法规当局采取另外的措施，来保障从印度出口至欧盟的原料药质量。

好资料，感谢楼主分享

印度完全无视法规，犯罪什么的更不在话下