"Financial impact on Indian generic drug exporters to USA is reported to be about Rs 30 lakhs for registration of each Abbreviated New Drug Application and about Rs 12 lakhs for filing of Drug Master File," Minister of State for Commerce and Industry D Purandeswari said in a written reply to the Lok Sabha.
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The Generic Drugs User Fee Act 2012 enables US Food and Drug Authority (USFDA) to charge a fee for registration of generic drugs. Any company interested in supplying drugs and pharmaceuticals to USA has to pay the prescribed fee to USFDA, she said.
She said the Indian office of USFDA has 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," she added.
In a separate reply, she said that out of nine spices parks, two - in Andhra Pradesh and Tamil Nadu - are nearing completion. While work is in progress for Rajasthan's coriander and cumin park, the project report is under preparation for the proposed parks in Uttrakhand and Arunanchal Pradesh, she added.
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