US FDA hikes fee for generic drug approvals

United state Food and Drugs Administration (USFDA) has hiked its fees by 30 percent for new generic drug applications.
Earlier the fee for Abbreviated New Drug Applications (ANDAs) was 58,730 dollars and now has risen by 30 per cent to 76,030 US dollars.
This fee is applicable from 1 October 2015. This move will hit Indian drugmakers as the generic medicines are sold on large scale in Indian market.
Meanwhile USFDA as reduced the fees for facility inspection of foreign companies, this will promote more firms to opt for audit of their facilities by the regulator US FDA.
Further the regulator has also increased the rates of Drug Master File (DMF) by twenty per cent making it 42,170 dollars. All above changed fees is valid till 30 September 2016.

  • 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.
  • Fees reduction in facility inspection will encourage Drug Company to opt for auditing from regulator.



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