India’s pact with Europe may choke its generic drug exports
International aid agencies have urged the Indian government to reject a free trade agreement it is negotiating with the European Union. The agreement may undermine India’s ability to produce cheap generic drugs. The concern stems from leaked sections of the text showing that the EU wants India to accept a data exclusivity provision which would force India’s generic manufacturers to submit their own data on safety and effectiveness to register the generic products. It will force generic manufacturers to repeat clinical trials already done by industry to get their drugs approved.BMJ 2011, 342, 1480