US hikes drug application fees by 24%

MUMBAI: Fees paid by domestic generic companies in seeking drug and API (raw material) approvals for US — the largest and the most lucrative market — have increased , and in some cases even doubled. The newANDA (abbreviated new drug application) fees of nearly $64,000 per application will kick off from October this year, increasing companies' expenses substantially and making them cautious on such filings. Not only have the fees been hiked, but to make matters worse, the weak rupee since May this year would be a double whammy for the domestic industry . 


The US Food and Drug Authority (FDA) has increased ANDA fees by 24% to $63,860 per application filed by pharma companies while drug master filings (dossier for APIs) have been hiked by nearly 48% to $31,460 for each application (see chart). 

Last year, the US drug regulator made amendments to introduce a generic drug user fee, 'Generic Drugs User Fee Amendment (GDUFA) 2012'. All generic companies, including Ranbaxy Laboratories , Cipla, Dr Reddy's and Lupin, are required to pay a fee to the US drug regulator while seeking permission to launch their products in the world's largest drug market while they also pay for supplying active pharmaceutical ingredients (APIs) for manufacturing generic drugs in the US.