EU is aiming at implementation of 'Directive on Falsified Medicines' to be effective from 2nd July this year with the objective of preventing falsified medicinal products from entering EU from other countries, The directives required all non-EU countries ,in order to export (Active pharmaceutical ingredients) APIs meant for medicinal products for human use in EU, to hold a “Written Confirmation” certificate for each such API unit to be issued by the enforcement authorities of that countries confirming compliance with GMP standards or rules 'equivalent to the rules applied in the EU', such as WHO GMP, 'International Conference for Harmonization' Q7 (ICH Q7), etc.

In this regards, Ministry of Health and Family Welfare, Government of India, have nominated “Central Drugs Standard Control Organisation (CDSCO) as the competent Authority for the purpose of issue of “WC” certification. CDSCO have already come up with the guidelines for issue of “Written confirmation” certificate duly approved by the Ministry of Health and Family Welfare and published it vide notification 7-5/2013/ DCGI/Misc(EU) dated 10th April 2013. The guidelines explicitly describes the preface, the purpose of the certification, documents required to be submitted for the application for the grant for the certificate, procedure of inspection by the.