Wockhardt says US export ban unlikely to be lifted until next year
Remedial action has been taken, said chairman Habil Khorakiwala, but he holds little hope of a swift restoration of exports to US
Mumbai: Drug maker Wockhardt Ltd’s steps to have the US lift bans on products from two of its plants are unlikely to approved until next year, its chairman said on Monday after the company posted a heavy fall in quarterly profit.
Last year’s bans by the US Food and Drug Administration (FDA) over quality control lapses halted exports to the US and were largely responsible for net profit in the three months to 31 September tumbling 97% year on year to ₹ 3.63 crore.
Remedial action has been taken, chairman Habil Khorakiwala said, but he holds out little hope of a swift restoration of exports to a market that previously accounted for half the generic drug maker’s global sales.
“We informed the FDA a few days ago that we are ready for an inspection any time," Khorakiwala told Reuters at the company’s Mumbai headquarters, adding that Wockhardt will not be able to hurry the US regulator.
“We don’t think this will happen in one quarter or so. It takes longer," he said.
Concerns over quality control in India’s export-driven drug industry surfaced over the past year after plants run by both Ranbaxy Laboratories Ltd and Wockhardt were banned from exporting to the US, damaging India’s reputation as a supplier of safe, affordable drugs.
Indian drug exports grew by only 2.6% in the fiscal year 2013-14 to 31 March. Two years ago, the growth rate was 23%.
In May, Wockhardt said FDA had also expressed concern over production processes at its Chicago-based Morton Grove Pharmaceuticals operation, which accounts for more than half of Wockhardt’s sales in the US.
Khorakiwala said Wockhardt has also taken steps to address the FDA’s concerns about Morton Grove and is awaiting a response from the regulator.
Despite the regulatory action, Khorakiwala said Wockhardt has been filing applications with the FDA for new generic drugs but approvals have been held up pending FDA clearance for its factories.
Wockhardt’s shares are up about 70% so far this year, mainly because of market rumours that the company could sell out to a foreign or domestic drug maker.
“We have no intention to do a sale and we will not do it in the future," Khorakiwala said on Monday. Reuters
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