Even as the European Union (EU) is all set to implement its 'Directive on Falsified Medicines' from July 2 this year, under which the APIs meant for medicinal products for human use would require written confirmation (WC) for each API unit by the enforcement authorities of the exporting countries, the drugs controller general of India (DCGI) has issued the revised draft guidelines for issue of WC certificate for export of active pharmaceutical ingredients (APIs) to EU.

The EU Directive is aimed at preventing falsified medicinal products from entering EU from other countries. As per the directive, the APIs meant for medicinal products for human use would require written confirmation for each API unit by the enforcement authorities of the exporting countries confirming complaints 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 the revised draft guidelines, the DCGI has listed the checklist for documents to be submitted for application of WC certificate for active substances exported to the EU for medicinal products for human use in accordance with Article 46(2)(b) of Directives No. 2001/83/EC.

The major documents mentioned in the checklist included the covering letter clearly specifying the intent of the application; an authorization letter in original issued by the Director/ Company Secretary/ Partner of the firm revealing the name and designation of the person authorized to sign; copy of GMP certificate issued as per WHO GMP, US FDA, EDQM, etc. if any; copy of Manufacturing License issued by SLA; list of all APIs approved by SLA; list of products applied for issue of WC; and list of SOPs and STPs.

The checklist also include master formula record and batch manufacturing record; summary of stability data (three batches) accelerated/ real time (as prescribed); list of equipment and instruments; list of technical staff, their qualification, experience and their approval by SLA; manufacturing layout plan as approved by SLA; validation master plan; summary of process validation data for three batches of each product; schematic diagram of water system specifying circulation loop and MOC; schematic diagram of HVAC system specifying terminal filter configuration; export data of last three years; good distribution practices followed by the firm; summary of annual product review; summary of market complaint review; summary data of impurity profiling; summary data of OVI; summary data of analytical method validation; schematic diagram of ETP; NSQ reports; legal undertaking stating that inspection/ investigation reports of any regulatory inspection by Indian regulatory authority including show cause notices/ suspensions/ cancellations if any shall be communicated to “competent authority” i.e. DCG(I), CDSCO within 15 working days; and site master file (as specified under WHO TRS 823).

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.