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 percent 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. These fees are effective October 1, 2015, and will remain in effect through September 30, 2016," the notification said.

A senior official of a pharma company told reporters 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 stated 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.

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