19/20 May 2021
As of 2 July 2013 each consignment of APIs to Europe must be accompanied by a written confirmation. This document shall prove the GMP compliance of the APIs delivered. Moreover, the exporting country has to control the API manufacturers concerned according to the EU GMP Standard (ICH Q7 or an equivalent standard). In many countries where APIs are manufactured, there are neither GMP requirements equivalent to those established in the EU nor systems suitable to the monitoring of API manufacturers. Today, the most significant manufacturing countries are India and China. Since the publication of the new requirements regarding the Written Confirmation on GMP Compliance concerns have been expressed that China and India won't be able to deliver all APIs to Europe. This would have a huge impact on the manufacture of medicinal products in Europe as many APIs aren't manufactured in Europe any longer.
The Indian website "Drug Regulations" reported on 14 January about the first concrete steps regarding Written Confirmations taken by India. The article quotes a statement made by the Pharmaceutical Export Promotion Council of India according to which the EU authorities have been informed by the Embassy of India about the designation of the Central Drug Standards Control Organization (CDSCO) as competent authority of India for the purpose of issuing the Written Confirmations. Reports were already published in September 2012 regarding this step. At that time, the Pharmaceuticals Export Promotion Council of India released an "Important Clarification" containing the announcement of this step which is now achieved.
Yet, the designation of a competent authority is only a small step. Indeed, India has to comply with a range of requirements to be able to issue Written Confirmations - among other things GMP requirements equivalent to those established in the EU and regular monitoring. In addition, the Indian authority have to inform immediately the respective EU authorities about major deviations observed during GMP inspections regarding GMP non-compliance. As the Indian GMP requirements are not equivalent to the European ones, it seems almost impossible to issue Written "GMP" Confirmations.