US-dependant Indian pharma firms must pay 12-15% more in FDA fees

Indian pharmaceutical companies, which are the biggest source of medicines exported to the US, will soon have to pay 12-15 per cent more in annual facility fees as the US Food and Drug Administration (FDA) has announced new rates.

US laws authorise the drug and health watchdog to assess and collect user fees for certain applications and supplements for human generic drug products.

The new rates, applicable on companies from all nations, are effective from 1 October and will remain in force through September 30, 2015, as per a communication from the FDA.

The foreign FDF (finished dosage form) facility will pay $262,717 (Rs1.6 crore) now as compared to $235,152 a year ago - an increase of 12 per cent.

India is home to over 150 FDA-approved plants, including facilities run by global drug-makers.

Of the total facilities identified as FDF, there were 271 domestic facilities and 410 foreign facilities, including those in India.

Similarly, a foreign API (active pharmaceutical ingredient) facility would attract $56,926 (about Rs. 34.7 lakh) as fees -- 15 per cent higher than the current rate.

Of the total facilities identified as API facilities, there were 103 domestic facilities and 692 foreign facilities.

Facility fees are required to be paid by those owning a facility, which is identified or intended to be identified in at least one generic drug submission that is pending or approved to produce one or more generic drug FDFs and/or APIs.

If a facility manufactures both generic FDFs and APIs, it incurs both annual FDF and annual API facility fees.

Foreign generic drug facility fees are about $15,000 higher than domestic plants as FDA reasons the differential reflects the additional costs of inspections funded.

For the US facilities, the FDF facility fee this year is $247,717 and the API facility fee is $41,926.

Interestingly, the total FDF and API fees collected from domestic as well as foreign facilities account for 70 per cent of the $312 million target fee revenue amount for FY 2015.

This is why, industry players say, the cut in filing fees this year provides little relief.

The new fee for drug master files (DMFs) is $26,720 (approximately Rs. 16.3 lakh), down 15 per cent year-on-year.

The rates for abbreviated new drug applications (ANDAs) have also been lowered about 8 per cent to $58,730. The same for PAS (prior approval supplement), which is equal to half the ANDA fee, will be about 7 per cent less at $29,730.