United state Food and Drugs Administration (USFDA) has hiked its fees by 30% for new generic drug applications. The fee for Abbreviated New Drug Applications was 58,730 dollars and now has risen by 30 % to 76,030 US dollars. This fee is applicable from 1st October 2015. This move will hit Indian drug makers as the generic medicines are sold on high scale in the Indian market. Mean while USFDA as reduced fees for facility inspection of foreign companies, this will promote the more firms to opt for audit of their facilities by the regulator USFDA. Ahead the regulator has also increased the rates of Drug Master File by 20% making it 42,170 dollars. All above changed fees is valid till 30th September 2016.
Implications:
The hike in fees for new generic drug will put extra burden on small generic drug-makers as its costing will increase and eventually will affect the customers in India who primly opt for generics due to its less pricing.
USFDA hikes fee for generic drug
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