By Zeba Siddiqui
MUMBAI (Reuters) - Drugmaker Wockhardt's steps to have the United States 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 U.S. Food and Drug Administration (FDA) over quality control lapses halted exports to the United States and were largely responsible for net profit in the three months to Sept. 31 tumbling 97 percent year on year to 36.3 million rupees ($591,446).
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 drugmaker'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 U.S. 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 and Wockhardt were banned from exporting to the United States, damaging India's reputation as a supplier of safe, affordable drugs.
Indian drug exports grew by only 2.6 percent in the 2013/14 financial year to March 31. Two years ago the growth rate was 23 percent.
In May Wockhardt said the 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 United States.
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 that 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 percent so far this year, mainly because of market rumours that the company could sell out to a foreign or domestic drugmaker.
"We have no intention to do a sale and we will not do it in the future," Khorakiwala said on Monday.
($1 = 61.3750 rupee)
(Editing by Sumeet Chatterjee and David Goodman)
