Comparison of EU GMP and Indian GMP Requirements for APIs

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

Because of the new requirements for importing APIs from non-EU countries, the question of similarities and differences in GMP guidelines of the different countries is being widely discussed.

In cases where GMP Guidelines in non-EU countries are found to be comparable to those in the EU, and if inspection is regularly carried out by a competent authority, the non-EU countries in question have the possibility to submit an application for the so-called list of 3rd countries. Those 3rd countries won't have to issue a Written Confirmation and will be able to export APIs into the EU after the 2nd of July 2013 without any further documentation. This explains the interest of so many countries to be included in the list. So far, Switzerland is the only country on the list of 3rd countries but it is expected that the USA should join it before the 2nd of July 2013.

What about countries like India? How different are the Indian regulations from EU's GMP Part 2 /ICH Q7? The website "Drug Regulations" has made a very extensive comparison of the respective GMP regulations. This comparison clearly shows that the European guidelines are much more comprehensive and detailed in many areas than the Indian GMP regulations.

Source: Internet service Drug Regulations.org