Indian drug makers to pay higher facility fees to USFDA
The US drug monitor announced new rates for annual facility fees, with rates for foreign facilities up by 12-15%
Washington: Drug makers from India, the biggest source of medicines to the US, may soon have to cough up 12-15% more in annual facility fees as the Food and Drug Administration (FDA) has announced new rates.
US laws authorize 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 2014 and will remain in force through 30 September 2015, as per a communication from the FDA.
A foreign FDF (Finished Dosage Form) facility will pay $262,717 (around ₹ 1.6 crore) now, compared to $235,152 a year ago—an increase of 12%.
India is home to over 150 FDA-approved plants, including facilities run by multinational companies. 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 as fees—15% 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 is 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 the FDA reasons that 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% of the $312 million target fee revenue amount for the fiscal year 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, down 15% year-on-year. The rates for abbreviated new drug applications (ANDAs) has also been lowered about 8% to $58,730. The same for PAS (prior approval supplement), which is equal to half the ANDA fee, will be about 7% less at $29,730.
The FDA estimates there will be 1,065 ANDAs and 449 PASs.
In case fees are not paid, no new generic drug submission referencing the facility will be received until fees are paid. Further, all FDFs or APIs manufactured in the non-paying facility and all FDFs containing APIs manufactured in such a facility are deemed mis-branded.
Indian companies usually supply about 20-25% of the medicines used in the US. America accounts for about 25% of India’s about $15 billion pharmaceuticals exports.
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First Published:3 Aug 2014, 03:59 PM IST
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