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Indian Drugmakers Suffer US Regulatory Pain

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Indian drugmakers expect a slowdown in new generic drug approvals by the U.S. 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.
 
A rise in the number of filings for new generic drugs from India and elsewhere, and the need to step up inspections of production facilities before giving final approval, is putting pressure on FDA resources, adding to the backlog, analysts said.
 
While the FDA is hiring more staff and looking to speed up the process, Indian pharmaceutical industry executives say the pace of approvals is unlikely to pick up until 2016.
 
Leading Indian generic drugmakers Dr Reddy's Laboratories Ltd and Glenmark Pharmaceuticals Ltd this month posted a drop in their second-quarter U.S. sales, blaming the slowdown in the approval process.
 
"The U.S. has been challenging in this year because of the significant slowdown in product approvals. The remaining half of this financial year will remain challenging for the industry," Glenmark Managing Director Glenn Saldanha told Reuters.
 
Approval Lag Takes Toll
Sun Pharmaceutical Industries Ltd, India's largest drugmaker by revenue, and Cipla Ltd, both due to report their quarterly results on Thursday, are also expected to be affected by the slowing approvals, analysts said.
 
While Sun Pharma is expected to report a 17 percent rise in net profit for the second quarter, helped by a pick-up in sales in its home market, Cipla is expected to report a 7 percent drop in the net profit.
 
"The (FDA approval) process will be streamlined with a lag, and that lag is still taking a toll on most companies," said Siddhant Khandekar, vice-president of research at brokerage ICICI Securities. "The implementation has already started, but we will probably see normalisation only by 2016."
 
FDA spokeswoman Sandy Walsh said the agency was on track with the implementation of the GDUFA and was "maintaining pace with historical performance". The FDA approved 45 new drug applications in August and September 2014 each, which was more than the monthly average for 2012 and 2013, she said.
 
"We remain committed to utilizing all available resources to ensure expeditious and complete (new application) reviews."
 
By 2017, the FDA aims to bring down the review time to 10 months from about 30 months now. For applications submitted in the year starting October 2014, the FDA has set a target to complete review of 60 percent within 15 months.
 
Some Indian generic drugmakers are, however, uncertain about the pace of approvals in the near future.
 
"Our inventory is lined up in the United States in anticipation of approvals, and we expect them to come in by January, if not December. But it is not in our control," Dr Reddy's finance chief Saumen Chakraborty said.
 
(Reuters)


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