Even as the D-date for implementation of European Union (EU)'s 'Directive on Falsified Medicines' is approaching fast, the drugs controller general of India (DCGI) has decided to issue first written confirmation (WC) certificates to the API exporters to EU based on accreditations held by the companies and also decided to waive requirements for submission of some documents, it is learnt.

As per the EU Directive, aimed at preventing falsified medicinal products from entering EU from other countries, the APIs meant for medicinal products for human use would require WC certificate for each API unit by the enforcement authorities of the exporting 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. The EU Directive will come into effect from July 2 this year.

According to sources, the DCGI has finalised the guidelines for issue of Written Confirmation for API exports to EU as required under Article 46 II(b) of Directive No. 2001/83/EC of EU and has also agreed to issue first WC certificates based on accreditations held by the companies. The first written confirmation will be granted based on valid Certificate of Pharmaceutical Product (CoPP) issued as per WHO guidelines or US FDA or EDQM/ TGA certificates (not more than 24 months old). If the company does not have any of these, then inspection will be conducted.

Likewise, the DCGI has also waived requirements for submission of some documents. The omissions that have been made from the 'Document Checklist' include master formula record and batch manufacturing record; schematic diagram of water system specifying circulation loop and MOC;  schematic diagram of HVAC system specifying terminal filter configuration; summary data of OVI; and schematic diagram of ETP.

Earlier in November last year, the union health ministry had made the CDSCO (DCGI office) as the competent authority for issuing WC certificate for each of its consignments ensuring compliance of the product with the good manufacturing practices (GMP) requirements of EU.