Indian Government moves closer to complying with EU API rules

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

Indian Government moves closer to complying with EU API rules

Home/Policies & Legislation | Posted 14/06/2013 0 Post your comment

On 23 May 2013, the Indian Government announced that it had issued finalized guidelines for drugmakers to comply with a European Union (EU) directive on standards for import of active pharmaceutical ingredients (APIs) into the EU that takes effect on 2 July 2013.

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.

Related articles

China and India still to comply with new EU API rules

EU API law causing concern among API producers

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: The Economic Times India, Indian Business Standard