What Is Wrong with APIs from China and India?

API manufacturers from India and China have more and more explaining to do. How is it possible that almost all of the CEPs withdrawn by the EDQM due to GMP inspections come from Asia, especially from India and China ?A CEP itself is no guarantee that an API is manufactured according to the GMP rules. Yet, this is a common misunderstanding. The API manufacturers only declare in their CEP dossier that they comply with the GMP rules. Until an inspection is conducted, no-one knows if this declaration reflects the truth and the manufacturing is in compliance with the GMP rules.Currently more inspections are performed in India and China, however, only 17% of all CEP holders have been inspected so far. What is more, such an inspection does not release the medicinal product manufacturer of his duty to regularly audit the API manufacturer himself. Yet, at the moment this does not seem to be done to the full extent either - there is no other way of explaining the recent CEP suspensions due to GMP deficiencies. Against this backdrop it seems nearly inconceivable when - as mentioned below - two Chinese API manufacturers refuse to have their sites inspected. It is not sure to what extent these manufacturers have worked in compliance with the GMP requirements. One of the certificates was issued in 2007 and the other one, in 2010. Manufacturers who used products from these suppliers have to evaluate if there are measures on the final product needed. We expect that the competent authorities in Europe will evaluate if actions are necessary. Just recently EMA requested a pharmacy level recall due to GMP deficiencies at an API production site in India.The EDQM announces the suspension of the following CEPs as a result of an inspection of the manufacturing sites:

Date Substance Name CEP Number
08/07/10 Flunarizine Dihydrochloride Fleming Laboratories Ltd IN 500 009 Secunderabad CEP 2004-142 Rev 00 Issued 03/10/2005
Loperamide Hydrochloride Fleming Laboratories Limited IN 500 016 Hyderabad CEP 2005-247 Rev 01 Issued 10/03/2010
08/07/10 Cinnarizine Fleming Laboratories Limited IN 500 016 Hyderabad CEP 2007-257 Rev  00 Issued 01/04/2009

As a failure to commitments of willingness to be inspected (refusal of inspection, reconstruction/restoration of sites to achieve GMP level, temporary closure of a site...) and/or to operate according to EU GMP:

Date Substance Name CEP Number
09/07/10 Oxytetracycline Dihydrate, Shandong Jinyang Pharmaceutical Co., Ltd. CN 255100 Zibo City CEP 2004-177 Rev 00 Issued  15/11/2007
09/07/10 Oxytetracycline Hydrochloride SHANDONG JINYANG PHARMACEUTICAL CO., LTD. CN 255000 Zibo City CEP 2008-165 Rev 00 Issued 12/05/2010

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