Any manufacturer exporting active pharmaceutical ingredients (APIs) to the European Union will now have to get a written confirmation from the Central Drugs Standard Control Organization (CDSCO) before exporting the consignment.
According to a notification issued by the commerce ministry on Thursday,exporters will have to get a written confirmation saying that the API has been manufactured in accordance with Good Manufacturing Practice (GMP) standards of the EU and that the API manufacturing facility is subject to control and enforcement of GMP standards,equivalent to those in the EU countries.
The change in regulations follows a 2011 directive of the EU,taking effect from July 2,which is aimed at preventing inferior APIs from entering the EU.
According to the EU,all such shipments are required to carry a guarantee that the API manufacturer has been inspected by its home country and that its products meet the EU GMP standards.
The directive lays down a system of control over the entire supply chain for pharmaceuticals encompassing manufacture and import to marketing,wholesale and retail distribution.
Currently,exporters of APIs to the EU countries should have a certificate of suitability issued by EU authority of a Drug Master File,filed with regulatory authorities of the member state. India and China are the largest producers of APIs in the world.
This is a welcome move. The CDSCO can now monitor exports and address quality issues promptly. The checks on the APIs will implement the standards more effectively, Ajay Sahai,director-general,Fieo,said.