The Central Drugs Standard Control Organisation (CDSCO) has issued the Guidance document for the issue of Written Confirmation (WC) certificate for active substances exported to the European Union (EU) for medicinal products for human use, in accordance with Article 46(2)(b) of EU Directives No. 2001/83/EC.

These guidelines are intended for the guidance of departmental offices and manufacturing firms. It sets out the procedure to be followed and documents required for the application for the issue of WC certificate. It also sets out procedures and nature of work that the headquarters, zonal, sub-zonal and port offices of the CDSCO will carry out and the guidelines about the policy that should be followed in disposing of the work and duties.

However, the procedure set out therein cannot also be quoted as legal authority. This guidance documents might be amended from time to time as per requirements after obtaining necessary approval from the competent authority.

After the Drugs Controller General of India (DCGI) was empowered in November last year by the union health ministry to issue the WC certificates to the API exporters of EU, DCGI Dr GN Singh has been pulling up all steps to ensure that the issuance of WC certificate is uniform and all the activities require to be implemented in rational way so that the whole system functions transparently in the country. This guidance document is seen as part of his effort to streamline this process and implementation of the new system by the applicants and all offices of CDSCO.

The EU has laid down the guidelines for Good Manufacturing Practices (GMP) for various drugs formulations vide its Directive No. 2001/83/EC dated November 6, 2001. These Directives have been amended seven times by Directive No. 2002/98/EC dated 08/02/2003, Directive No. 2003/63/EC dated 25/06/2003, Directive No. 2004/24/EC dated 30/04/2004, Directive No. 2004/27/EC dated 30/04/2004, Regulation No. 1901/2006 dated 27/12/2006, Regulation No. 1394/2007 dated 10/12/2007, Directive No. 2008/29/EC dated 20/03/2008 and the eight amendment shall be effective from July 2, 2013.

This eighth amendment termed as Directive No. 2011/62/EU dated June 8, 2011 lays down the guidelines to be undertaken for following of GMP for APIs, sale of drugs through internet, addition of terminologies as falsified medicine, brokering of medicinal products, etc. Among the salient features of the Directives is the issue of “Written Confirmation” for active substances exported to EU for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC, a certificate to be issued by the “Competent Authority” for the country and the same shall be notified to the EU for their reference.

The EU shall allow only those manufacturers to import the APIs to Europe those who are having the “Written Confirmation” issued by the “Competent Authority” for the country. The “Competent Authority” shall be responsible for forwarding any Non Compliance reported to EU immediately for necessary action by EU.