Government sets guidelines to meet EU drug import rules

 

The government said on Thursday it had set guidelines for pharmaceutical makers to comply with a European Union directive on standards for import of bulk drugs into the EU that takes effect on July 2.

 

Under the new rules, India must certify that bulk drugs, or active pharmaceutical ingredients (APIs), meet European quality standards. The current regulation requires that the certification be done by the country to which the APIs are being exported.

 

"Various EU industry members have been expressing their concern about the ability of India to comply with the new procedure by the deadline of 2nd July 2013. However, government of India is optimistic that its pharma industry would be able to meet regulatory requirements within the given time frame," the government said in a statement.