Regulatory Focus™ > News Articles > India Finalizes Guideline Meant to Bring Country into Compliance with New EU API Rules

India Finalizes Guideline Meant to Bring Country into Compliance with New EU API Rules

Posted 24 May 2013 | By

India has issued new guidelines meant to bring the country-and its significant generic pharmaceutical industry-into compliance with new EU rules requiring that active pharmaceutical ingredient exports to the region be accompanied with attestations that the products were manufactured to good manufacturing practice (GMP) standards, reports the India Times.

The EU's requirements are set to come into effect on 2 July 2013, and a number of countries, including China and Brazil, have been scrambling to make sure they are in compliance with those requirements, wary of their potential effects on their local pharmaceutical industries, all of which rely heavily on exports to the EU.

In March 2013, India's Central Drugs Standard Control Organization (CDSCO) issued a draft guideline regarding the "Written Confirmation" procedure that industrial exporters will be required to follow when exporting APIs. Both the EU and India recognize the CDSCO has the "Competent Authority" for the country, as it regulates pharmaceutical products and their components.

The Times reports that the guideline has now been finalized, bringing the country into compliance with EU standards mere weeks before APIs manufactured in the country would have been banned from the EU.

Read more at The Times' website here.


Tags: API, EU

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