Tuesday, July 31, 2012

Eu's Newly-Changed Rules On Cgmp Certificate For Bulk Drug Exports

Date :31-Jul-2012
Subject :EU's newly-changed rules on cGMP certificate for bulk drug exports
With the European Union (EU) changing the rules for importing active substances into EU for medicinal products for human use, India may convey the apprehensions of the Indian active pharmaceutical ingredients (API) exporters about the rising cost of transaction costs and seek exemption.

The Commerce Ministry is learnt to have taken note of the changed rules by the EU to be made effective from January 2013 on making mandatory the current good manufacturing practices (cGMP) certificate from the local regulatory authority for all bulk drug exports.

The industry had also apprised the Drug Controller General of India (DCGI) about the hardships including the increase in transaction costs due to the amended laws. Industry leaders, terming the new laws as another non-tariff trade barrier, had urged the Commerce Ministry and the DCGI to take up the matter with the European Union.

Sources said India may convey these apprehensions to the EU in a formal way and seek exemption as sought by some countries like Israel and Switzerland. “The matter is under consideration of the authorities,”a senior official from the Commerce Department said.

To read the remainder of the article click here.

No comments: