The Central Drugs Standard Control Organisation (CDSCO) will soon start issuing the mandatory Written Confirmation (WC) certificate to the Indian API exporters to European Union (EU) on providing the 6 months long term stability data against the earlier one-year period.

According to sources, the CDSCO has been getting recommendations from its zonal offices for grant of WC certificate wherein long term stability data and accelerated stability data submitted by the companies are lesser than the period of 12 months and six months respectively.

“The matter has been examined in detail. While renewing our commitment to the spirit of the GMP and also keeping in regard the international practices, it has been decided that applications containing 6 months accelerated and 6 months long term stability data on 3 batches and if no major changes from the specifications have been observed, issue of Written Confirmation certificate to such APIs would be considered”, Drugs Controller General of India (DCGI) Dr GN Singh said.

For this, the DCGI has put forward two conditions. One, the firm should submit the stability protocol among with the undertaking or a stability commitment that an ongoing stability programme is in place and they shall submit the data covering the retest periods/shelf life of the API within 30 days on completion of the studies to the concerned CDSCO zonal office.

Second, the firm should assign retest/expiry date of the API based on available stability data as per the procedure laid down in the ICH Guidelines. The firm should provide a commitment regarding the retest period/shelf life of the API.  

The EU had mandated through its Directive No 2001/83/EC dated 8th June, 2011 that every consignment of API from non-EU/non-listed countries must be supported by a Written Confirmation (WC) certificate issued by the competent authority of that country, stating that the consignment conforms to the standards of GMP as laid down in the EU guidelines or equivalent thereof. This became effective from July 2, 2013.
 
The EU Directive is aimed at preventing falsified medicinal products from entering EU from other countries.