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is this why fda delays are getting longer?, page-18

  1. 328 Posts.
    From The Economist, 5 April 2011:

    http://viewswire.eiu.com/index.asp?layout=ib3PrintArticle&article_id=1447933129&printer=printer

    "In many ways these are good times for Dr Reddy's, India's second largest drug concern. In 2009, the company slipped into a loss, thanks to write-downs relating to its 2006 acquisition of German drug-maker betapharm. Now it is back in profit. But the good news has been tarnished by health and safety problems at its plants, which are damaging the company's reputation.

    In late March 2011, Dr Reddy's was charged by the Director of Factories for Andhra Pradesh with responsibility for the deaths of two workers at a manufacturing unit at Bollaram, a suburb of Hyderabad, the city where the company is based. The two died in December 2010 from a possible leak of poisonous gas. Investigations are underway by the same Andhra Pradesh authorities into another accident at a company facility in mid-March 2011, in which two workers burned to death in a lift. Further charges could therefore follow within 90 days of this second tragedy.

    It also remains to be seen how the US Food and Drug Administration, which has approved the facilities at which both the accidents occurred, will respond when it next conducts audits. The repercussions from the incidents could therefore be wide-ranging, though for the time being it is probably the impact on the company's good name that it is most damaging."

 
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