Under the new rules, which are part of the EU’s Falsified Medicines Directive, India must certify that bulk drugs, or active pharmaceutical ingredients (APIs), meet European good manufacturing practices (GMP) standards. The current regulation requires that the certification be done by the country to which the APIs are being exported.

Although concern has been expressed that some countries may not be able to put the necessary systems in place by July 2013 to be able to issue written confirmation of GMP compliance, India has alleviated these concerns. In fact, the Indian Government has stated that it ‘is optimistic that its pharma industry would be able to meet regulatory requirements within the given time frame’.

The government is also planning to initiate an online application filing and tracking system to speed up the process and bring increased transparency to the system.

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