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Mylan Says Indian Drug Industry Needs More Transparency From FDA

  • Indian drug industry working with regulator to improve process
  • Mylan has ‘moved on’ from Perrigo bid, President Malik says

Mylan NV President Rajiv Malik said the Indian drug industry is starting to get frustrated with U.S. regulators over a lack of transparency in the process for resolving sanctions after a wave of actions last year halted new product approvals at many plants.

Canonsburg, Pennsylvania-based Mylan in 2013 purchased Bangalore-based Agila Specialties Pvt., and three of its facilities were among Indian drug plants to last year receive Food and Drug Administration warning letters over deficient manufacturing practices. Heavyweights Sun Pharmaceutical Industries Ltd., Dr. Reddy’s Laboratories Ltd. and a string of other domestic companies also received warning letters from the U.S. last year. Factories that get such warnings can face restrictions on producing new drugs for U.S. consumption.

"There’s a general sense of frustration that maybe there can be a much better defined process with some visibility, because businesses need to make calls about how long they are under water, when they can hope to come out of it," Mylan’s Malik said in a telephone interview. "The problem is there’s a process, but there’s no transparency about the process. There’s a timeline but there’s no transparency about the timeline."

The Indian pharmaceutical industry is working with the FDA to make the resolution of the regulatory issues more transparent, Malik said. Dilip Shanghvi, Sun’s managing director and largest shareholder, said last month Sun was on track to request re-inspection of its affected facility by the end of June though the timing of FDA action after that was unclear, while Dr. Reddy’s said in May it was done with 50 percent of its compliance issues.

The U.S. FDA couldn’t be reached for comment outside of regular business hours.

Though Mylan’s Indian business has achieved its revenue targets, the company has replaced its workforce there and is training new employees from scratch to ensure the faulty practices which caused the trouble did not continue, Malik said. Given the troubled Indian plants came through an acquisition, the experience will make Mylan more cautious on what it buys in the country going forward, he said.

"We’ll be more vigilant," Malik said. "Our own diligence process has gone to a whole other level because we have learnt what we would have done differently, better."

Malik has about 30 years of experience in the global generic pharmaceutical industry. Among other positions, he was head of Global Development and Regulatory at Sandoz. He began his R&D career at India’s Ranbaxy Laboratories Ltd., where he was head of generics R&D.

Whether in India or elsewhere, Mylan is not looking for large acquisitions after agreeing to purchase Swedish drugmaker Meda AB in a $7.2 billion deal in February, Malik said. The Meda deal came after Mylan failed in its attempt to acquire Dublin-based Perrigo Co. Joseph Papa, the Perrigo chief executive who fended off Mylan’s $26 billion takeover bid last year, has since left to take the helm at Valeant Pharmaceuticals International Inc.

"We have moved on," Malik said. "I don’t think we need to do anything more at this time and look into Perrigo."

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