Levying of Additional Fee on Sale of Generic Drugs.

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....evying of Additional Fee on Sale of Generic Drugs. <br>News and Press Release<br>Dated:- 13-8-2012<br><BR>Press Information Bureau Government of India Ministry of Commerce & Industry 13-August-2012....

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.... 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 o....

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....f 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 i....

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....ntended 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 ....

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....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 S....

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....tate for Commerce & Industry Shri Jyotiraditya M. Scindia in written reply to a question in Lok Sabha today. DS/GK<BR> News - Press release - PIB....