Pharma Exporters To US Under Pressure

Recent USFDA hike of fee for processing ANDA will certainly going to put immense pressure on the Indian pharma industry, resulting eviction of many small players from this pharma export business.

- Nitin Konde

United States’ Food and Drug Administration (USFDA), recently has increased the fee for processing Abbreviated New Drug Application (ANDA) by over $ 1 lakh to $ 1.71 lakh for the fiscal year 2018. This move is considered as a major setback for the Indian drug makers which accounts for major chunk generic medicines sold in that country. The hike was made under Generic Drug User Fee Amendments of 2017 (GDUFA II). The fee in FY17 was $ 70,480.

According to a notification on USFDA's website, fee for Drug Master File was reduced to $ 47,829 for 2017-18 from $ 51,140 in the last fiscal. These fees are effective on October 1, 2017, and will remain in effect through September 30, 2018.

The move will hurt the Indian pharma industry which is heavily dependent on the US market for exports, said a top official of Pharmaceuticals Export Promotion Council of India (Pharmexcil), a body under the Ministry of Commerce and Industry.

According to the Pharmexcil, this step will certainly going to put immense pressure on the Indian pharma industry and hence, resulting eviction of many small players from this pharma export business. However, the FDA has reduced the inspection fee for overseas Finished Dosage Firms to $ 2,26,087 from previous $2,72,646. Similarly, the inspection fee for overseas API (Active Pharma Ingredient) plant was fixed at $ 60,367 from previous $ 59,234.