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Not moving on yet! Seems like there is now concern in India at...

  1. 328 Posts.
    Not moving on yet! Seems like there is now concern in India at the impact of 4 fatalities in two accidents,3 months apart,might have on what the FDA thinks about Dr eddy's

    Part of a report in the The Hindu Business Online last Saturday

    http://www.thehindubusinessline.com/companies/article1574017.ece?homepage=true

    "DENT ON IMAGE

    The Hyderabad-based company (Dr Reddy's) is likely to face some adverse impact from the USFDA side as two accidents, in a span of about three months, had claimed four lives given the recent tough stand on regulatory aspects by the agency, said industry sources.

    ?These type of accidents are generally noted by the USFDA to be specifically looked into during subsequent audits for facility approval" aid a Mumbai-based consultant for regulatory issues abroad.

    When contacted Dr Reddy's spokesperson said: ?The USFDA comes into picture on matters concerning Good Manufacturing Practises (GMP) issues. However, we will bring to their notice safety related incidents in the following audit, whenever it takes place."
 
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