NEW DELHI -- U.S. regulators slapped an import ban on some products of top Indian drugmaker Sun Pharma, sending the firm's shares tumbling Thursday and dealing a fresh blow to the nation's beleaguered generics industry.
The U.S. Food and Drug Administration announced an "import alert" late Wednesday on drugs made by Sun at one of its plants in western India over failure to meet "good manufacturing practices."
The FDA action against India's largest drugmaker by market capitalization comes as U.S. regulators scale up scrutiny of India's $14-billion-a-year pharmaceutical sector to eliminate quality lapses and worries about safety.
Sun's shares fell as much as 6.4% before recovering slightly to close down 3.3% at 551.70 rupees.
The Sun plant in Karkhadi, Gujarat state, is one of around 10 owned by the company in India and produces ingredients for medicines as well as drugs themselves.
The import ban will remain in place until the FDA is satisfied "the appearance of a violation (of good manufacturing practices) has been removed" either through re-inspection or documentation, the regulator said.
The action against Sun is the latest in a string of FDA moves against Indian generic drug manufacturers.
A Sun spokeswoman said the import alert was issued by the FDA as a follow-up to a plant inspection in which "some noncompliance of current good manufacturing practice regulations were identified."
"The company remains fully committed to compliance and has already initiated several corrective steps," the spokeswoman said in a statement, adding the FDA move would not affect Sun's revenues.
A Second Setback
But in another blow to India's generics sector, the FDA said on its website that another leading Indian drugmaker, Dr Reddy's Laboratories, was voluntarily recalling 58,656 bottles of heartburn drug lansoprazole in the United States due to contamination.
India, known as "pharmacy to the world" with its vast generics market, supplies medicines to more than 200 countries -- many in the emerging world -- and is the second largest supplier of drugs to the United States after Canada.
But U.S. medical professionals have increasingly been voicing worries about the quality of copycat medicines, with generic drugs accounting for nearly four-fifths of prescriptions written out in the United States.
Over the past few years, the FDA has banned imports from the India-based factories of Ranbaxy Laboratories, the nation's largest pharmaceutical company by sales, citing rampant manufacturing quality problems.
The FDA has also targeted major drugmaker Wockhardt, blocking it from producing drugs for the U.S. markets from some of its plants over quality issues.
Earlier this week, the FDA said Sun voluntarily recalled 2,528 bottles of a generic diabetes drug from the U.S. market after a customer complained one bottle contained an epilepsy medicine.
Last weekend, Ranbaxy announced it was withdrawing two batches of Atorvastatin calcium tablets, a generic version of Pfizer's (IW 500/22) cholesterol-busting drug Lipitor, after a complaint about wrong dosage.
Copyright Agence France-Presse, 2014