Press Information Bureau

Government of India

Ministry of Commerce & Industry

13-August-2012 16:34 IST

Levying of Additional Fee on Sale of Generic Drugs

As per the information available in the website of United States Food and Drug Authority (USFDA), Generic Drug User Fee Amendments act of 2012 came into effect on 9.7.2012 enabling USFDA to charge a fee for registration of Generic Drugs.

A clarification was sought from the Indian office of USFDA, who clarified that the Enactment is intended to streamline the application review and inspection process and to reduce the review time from an average 31 months to 10 months in the next 5 years. It was also clarified that this enactment is applicable to both national and international generic industry. Thus no additional fee from Indian pharmaceutical industry is proposed to be levied.

This information was given by the Minister of State for Commerce & Industry Shri Jyotiraditya M. Scindia in written reply to a question in Lok Sabha today.

DS/GK

Generic drug user fees after US enactment may be applied, but no additional levy is proposed on Indian manufacturers. The Generic Drug User Fee Amendments Act of 2012 authorises the USFDA to charge a registration fee for generic drugs to streamline application review and inspections and reduce review time; the USFDA's Indian office clarified the measure applies to national and international manufacturers but stated no additional fee specifically targeting the Indian pharmaceutical industry is proposed.