As U.S. regulators push hundreds of new generic drugs to market in an effort to drive down prices, the industry is facing a continuing problem in India, where many copycat medicines are manufactured.
The Food and Drug Administration approved a record 763 generic drugs in the year ending in September 2017. It expects to sign off on even more rivals for branded drugs in 2018. FDA Commissioner Scott Gottlieb has vowed to tackle a lack of competition he has said is “a root cause of high drug prices.”
But getting more low-cost medicines to pharmacy shelves could strain a global supply chain already confronting questions bout quality and safety -- especially in India, where about 40 percent of generic drugs taken by Americans are made.
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