The Economic Times reports that lobbying efforts are intensifying from India with respect to a new amendment to EU's legislation for "falsified medicines".
India's pharma industry is upset with the legislation which calls for the EU to carry out pre-market inspections of manufacturing facilities. India sees this as a further attempt to block imports to the EU. This is particularly true as the EU does not have enough resources to perform all the pre-market inspections necessary and effectively would eliminate many Indian companies' ability to export to EU. India also does not have the resources to perform the inspections by proxy were the EU to agree to that as an alternative.
This would seem to cut out a cheap source of drugs to the EU. Indian companies currently export about 25% of their output to the EU. The Indian Pharmaceutical Alliance (IPA) says this is another transparent attempt by the West to render India uncompetitive.
India already has 119 US FDA inspected plants, the highest number outside of the US. India says that it has been selling to the EU for years and that should continue while these issues are resolved.
If that weren't cheery enough, Kaiser Daily Global Health looks at EU-India free trade (FTA) negotiations. Fears are arising that the trade deal is taking a shape that will hinder India's historic position as generic leader in the world (20% of world volume) and in particular as supplier to developing Nations. India has been the most important supplier of drugs to treat AIDS, tuberculosis, and malaria - with low costs generics.
The fear is that the trade agreement will reduce the poor's access to drugs. Purportedly the FTA contains provisions to extend data exclusivity, patent term extensions, and enforcement of IP rights that will reverse advances that have been made on access to medicines. Patient Advocacy groups are calling for greater transparency to the negotiations and draft agreement.
Posted by Bruce Lehr May 2nd 2010.