Sunday, January 11, 2015

Govt wants its officials present during FDA inspections at pharma units

Hyderabad: Perturbed by Indian drug-makers frequently running into overseas regulatory problems, the government has requested the US health watchdog FDA to allow its officials during inspections of domestic pharma units.  While Indian pharma exports continue to grow and may touch $16.5 billion this year, many Indian pharmaceutical companies have faced regulatory action by the US Food and Drug Administration (FDA) in the recent past for alleged violation of 'good manufacturing practices' and other irregularities at the drug facilities in different parts of the country.  more

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