The Generic Drugs User Fee Act 2012 (GDUFA) enables United States Food and Drug Authority (USFDA) to charge a fee for registration of Generic Drugs. Any company interested in supplying drugs & pharmaceuticals to USA has to pay the prescribed fee to USFDA.

Financial impact on Indian generic drug exporters to USA is reported to be about Rs.30.00 lakhs for registration of each Abbreviated New Drug Application (ANDA) and about Rs.12.00 lakhs for filing of Drug Master File (DMF).

The Indian office of USFDA have clarified that this enactment has been done to streamline the application review and inspection process and to reduce the review time from an average 31 months to 10 months. This enactment is applicable to both national and international generic industry. No additional fee on Indian pharmaceutical industry is levied.

This information was given by the Minister of State for Commerce & Industry, Dr. D Purandeswari in a written reply in the Lok Sabha today.

DS/RK

(Release ID :93407)

Generic drug user fees now fund and accelerate application review and inspections, applying to domestic and international manufacturers. The Generic Drugs User Fee Act 2012 imposes prescribed user fees on registration submissions for generic pharmaceuticals to fund and expedite application review and inspections, applying to both domestic and international manufacturers and tying fees to specific filing categories such as abbreviated new drug applications and drug master files.