US regulator FDA has hiked its fees for new generic drug applications by up to 30 per cent, a move that may hit hard Indian drugmakers, which account for a major chunk of generic medicines sold in that country.
However, the fees for facility inspection of foreign companies have been reduced, which may encourage more firms to opt for audit of their facilities by the regulator.
The US Food and Drug Administration (USFDA) has increased the fee for Abbreviated New Drug Applications (ANDAs) to USD 76,030 from October 1, from USD 58,730 currently.
According to a notification issued by the drug regulator, fee for Drug Master File (DMF) will also be costlier by over 20 per cent at USD 42,170 while fees for inspecting domestic and foreign API and FDF facilities will be slightly reduced.
“For 2015-16, the generic drug fee rates are: ANDA USD 76,030, PAS USD 38,020, DMF USD 42,170, domestic API (active pharmaceutical ingredient) facility USD 40,867, foreign API facility USD 55,867, domestic FDF finished dosage form facility USD 243,905, and foreign FDF facility USD 258,905,” the notification said.
“These fees are effective October 1, 2015, and will remain in effect through September 30, 2016.”
A senior official of a pharma company told PTI that FDA has raised the user fee despite several requests from the Indian pharma industry, which plays a vital role in the generic drug market there.
“They must have reduced the fee for facility inspection to encourage more companies to go for audit,” the official added.
The official said Indian pharma feels that the user fee being charged by FDA is very high and the further hike will become a burden for small players.
“Fees for ANDA, PAS and DMF will increase in FY16 over the corresponding fees in FY15 due to a drop in the number of submissions in each of those three categories over the course of 2014—15. The fees for all types of facilities will decrease in FY16 over the corresponding fees in FY15 due to an increase in the number of facilities that self—identified for FY16,” FDA further said.
The individual fee will be recalculated each fiscal year and that of 2016—17 will be adjusted for inflation and other factors, including the projected number of ANDAs and PAS based on experience.
When an ANDA or PAS is refused in certain circumstances, a partial refund may be possible. If the reason for refusal is not related to failure to pay fees, then 75 per cent of the fee paid will be refunded to the applicant, the regulator said.