Novartis not sweating generics turmoil

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India's generic drug quality control issues do not have Novartis on edge. CEO Joe Jimenez told Reuters that the spate of bans and site closures will hit small generics players hardest, while bigger drugmakers will be able to invest in quality control that will keep generic drugs flowing into US markets.

“They are going to have to invest disproportionately in quality assurance assets that significantly change their cost structure and they may not become competitive on price,” he told Reuters. The CEO said that the generic Sandoz unit is critical to Novartis in part because “it allows me to sit down with health ministers and talk about how Novartis can help lower healthcare costs.”

The US has been navigating an ongoing series of quality issues, and has said it is working with India's regulator to keep manufacturing in synch with US standards.

Recent problems have included Sun Pharmaceutical's recalling of 2,528 bottles of the diabetes medication metformin hydrochloride because an anti-seizure medication was mixed in with the blood-sugar controlling medication, and a Ranbaxy generic Lipitor recall because 20mg doses were mixed in with 10mg ones.

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