<h1>USFDA Fees Impact Indian Generic Drug Exporters: Rs.30 Lakhs for Applications, Rs.12 Lakhs for Drug Master Files.</h1> The Generic Drugs User Fee Act 2012 allows the USFDA to impose fees on companies registering generic drugs for sale in the USA. Indian exporters face costs of approximately Rs.30 lakhs for each Abbreviated New Drug Application and Rs.12 lakhs for a Drug Master File. The aim is to streamline the review process, reducing the time from 31 months to 10 months. The fees apply to both domestic and international generic drug industries, with no extra charges specifically for Indian companies. This was confirmed by the Minister of State for Commerce Industry in a written statement to the Lok Sabha.