For coordinating issues arising out of the issuance 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, the department of pharmaceuticals (DoP) has constituted a three-member committee under the chairmanship of joint secretary, department of commerce.

Deputy Drugs Controller General of India (Dy DCGI) and Director General, Pharmexcil are the other two members of the committee.

According to sources, the DoP has formed this committee to resolve and for coordinating issues arising out of the issuance of WC certificate which is a new procedure in the country that has been necessitated by the EU Directive No. 2011/62/EU which will come into force from July 2, 2013.

As per this EU Directive, which is aimed to prevent falsified medicinal products from entering EU from other countries, the active pharma ingredients (APIs) meant for medicinal products for human use require WC certificate for each API unit by the enforcement authorities of the exporting countries confirming compliance with GMP standards/rules 'equivalent to the rules applied in the EU', such as WHO GMP, 'International Conference for Harmonization' Q7 (ICH Q7), etc. effective from July 2, 2013.

But the exporters view this as a cumbersome exercise and had earlier asked the authorities to takes up the issue with EU for accepting Indian GMP as equivalent to that of EU CGMP to make export of APIs to Europe hassle-free. They argued that inspections and other regulatory obligations being followed or enforced for Indian GMP for APls under the provisions of Schedule M of Drugs & Cosmetics (D&C) Act are also equivalent to that of EU CGMP. They further pleaded that the hassles of issuing WC certificates to each company exporting the APls to EU can be avoided if the DCGI takes up the issue with EU for accepting Indian GMP as equivalent to EU CGMP.

But, the Indian authoritative so far did not succeed in this, forcing the exporters to apply for the cumbersome WC certificate from the DCGI who has been earlier empowered by the union health ministry to issue this certificate.