Indian drugmakers see US sales hit by delay in new approvals


Indian drugmakers expect a slowdown in new generic drug approvals by the US Food and Drug Administration (FDA) to weigh on sales in their largest market for at least two more quarters, due to an ongoing overhaul of the review process. India’s $15 billion pharmaceutical industry, which has been hit by a spate of regulatory sanctions in the past year due to concerns about production processes, supplies about 40 percent of generic and over-the-counter drugs to the United States. The FDA implemented the Generic Drug User Fee Act (GDUFA) programme in October 2012, giving the agency the right to collect fees from manufacturers to expedite the approval for sale of generic drugs. But the agency has not made as much progress with clearing the existing backlog of applications for cheap copycat drugs as some Indian manufacturers had hoped, company executives said, which is now beginning to drag on sales in the United States.

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