India's generics industry is a major supplier of lifesaving drugs, including antiretrovirals for HIV, to the United States and over 200 other nations.
Many lower-income countries rely on the generics produced by Indian plants as a key source for affordable medicine.
But Ranbaxy, one of India's biggest drugmakers, has been hit repeatedly with FDA import suspensions, most recently in January, when a fourth manufacturing plant was cited for violations from expected "good manufacturing practice."
Roger Bate, an expert at the American Enterprise Institute, said the problem lies with India's national regulatory body for pharmaceuticals, the Central Drugs Standard Control Organization.
"I believe the Indian generics companies can make the products well, but it is the lack of oversight," Bate told AFP, describing CDSCO as "corrupt.
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"India does not take drug regulatory matters seriously."
The FDA issued earlier its first-ever ban on tobacco products on four varieties of hand-rolled