For some, steep hike by almost 50%.
By Deepak Chitnis
WASHINGTON, DC: The US Food and Drug Administration (FDA) is increasing its fees for manufacturers of generic over-the-counter drugs, many of which are companies based in India.
The fees are being increased by up to 48% in some cases, which is significant for Indian companies, as they constitute roughly 10% of the generic drug market in the US, an industry worth about $30 billion annually. The fee increase will go into effect on Oct. 1st of this year.
Despite the steep hike, the FDA maintains that it has done all it can to keep the rise as low as possible. Nevertheless, it expects companies to make the necessary adjustments in order to meet the increase. All this comes as part of the Abbreviated New Drug Application (ANDA), which includes a fee with it. That fee was originally just $51,520; now it has increased to nearly $64,000, a hike of roughly 24%.
The ANDA is a critical and mandatory step for drug approval, since it requires information on facilities of manufacture, process of manufacturing, and other such information.
In addition, the Prior Approval Supplement (PAS) fees have been increased by 24%, and will now cost nearly $32,000. This price hike will also go into effect at the beginning of October this year.
The steepest increase – 48% – belongs to the Drug Master File fees, which are now just $31,460. The Finished Dosage Forms (FDF) will increase to $220,152 and $235,152 for domestic and foreign facilities, respectively.
To contact the author, email to deepakchitnis@americanbazaaronline.com