Drug Controller General of India hosts quality workshop with FDA

The Drug Controller General of India has taken FDA Commissioner Margaret Hamburg up on her offer of closer cooperation, holding the first of a series of workshops for Indian drugmakers to help them deal with quality expectations from the U.S. regulator. Leslie Ball, FDA deputy director for the office of international programs, pointed out that there had been spike in violations by Indian companies and they quality needs to be their top concern, The Economic Times reports. Hamburg visited India earlier this year meeting with government and industry leaders and stressing quality. The agency has in the last year, issued import alerts banning products from two plants operated by Ranbaxy Laboratories and two by Wockhardt, as well as sent warning letters to other Indian facilities. The bans have taken a toll on India's drug exports. Story | More