Indian pharma companies may have to shell out more to sell drugs in the US. According to the Generic Drugs User Fee Act (GDUFA) passed in July last year, plants that manufacture generic drugs that are either pending approval or approved are required to pay facility fees annually.
The US FDA recently notified the actual annual fee to be paid by formulation and active pharma ingredient (API) facilities for the period October-September 2013.
While a US-based finished dosage facility will need to pay $1,75,389 ( Rs 0.9 crore) for year ended September 2013, the fee is higher at $1,90,389 (Rs 1 crore) for facilities located outside the US. For instance, Cipla may have to pay Rs 1 crore by March 2013 to file products from its Indore SEZ plant.
API facilities
Similarly, API facilities located outside the US will have to pay more than the ones located in the US. While the fee for US-based API facilities has been fixed at $26,458 for this year, facilities located outside the US are required to pay $41,458.
However, the fee difference between US and non-US facilities cannot exceed $15,000 for the current period.
For the current year, companies have been allowed to make the payment before March 3.
However, for the subsequent periods, the payment needs to be made on October 1 or the first business day thereafter.
Earlier in October last year, FDA notified the fee for generic ANDA and DMF (Drug Master File) filings. Accordingly, companies have to pay a filing fee of $51,520 (Rs 0.28 crore) for a generic filing for finished dosage formulation (Abbreviated new drug application) and $25,760 (Rs 0.1 crore) for an API (DMF) filing.
This has led to rationalisation of generic filings by pharma companies.
For instance, the cumulative drugs pending approval for Dr Reddys Labs declined from 80 in the June quarter to 63 by September quarter.
This was largely due to withdrawal of filings for select products.