Pharmaceutical Export Promotion Council of India (Pharmexcil) is planning to organize interactive session with officials of European Commission in Hyderabad to dispel apprehensions and doubts among the Indian exporters regarding the recent European Union (EU) directive of new importing regulations for APIs into EU. The meeting is scheduled to be held on September 13.

Recently, the European Union has modified its rules for importing active substances for medicinal products for human use (Active Pharmaceutical Ingredients) into EU and had issued new guidelines. In its directive the EU had stated that all imported active substances should be manufactured in compliance with standard of good manufacturing practices (GMP) at least equivalent to the GMP of EU. The new directive will come into effect from 2nd July 2013.

The manufacturing standards in the EU for active substances are those of the 'International Conference for Harmonization' - ICH Q7. In view this, there have been lot of apprehensions and doubts among the Indian pharma exporters.

As part of this, Stefan Fuehring, Policy Officer, looking after quality, safety and efficacy of medicinal products in the Directorate General of Health and Consumers, European Commission is visiting Hyderabad. He is expected to give presentations on ‘Quality of Medicines and Technology Solutions on Falsified Medicines’ and ‘New rules on importing APIs into the European Union’.

Industry analysts also feel that EU has come out with these regulations due to pressure from its own industry to contain API exporters from India and China in to EU. In view of this, India and China had even come on one platform to protest against EUs regulations.

In this context, the council feels that by organizing an interactive meeting with the European Commissions, the members will get an insight into the new regulations and thereby it will help the Indian exporters get their doubts cleared.

“As members are apprehensive about the new EU regulations, this interactive meeting is a very good opportunity. They can have a one to one chat with Stefan Fuehring and can get their doubts clarified,” said Dr P V Appaji, DG, Pharmexcil.