BackMylan warned by FDA over drug quality in three Indian plants
The violations include failure to establish and follow written procedures to prevent microbiological contamination and use of torn gloves
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Washington: Mylan NV, one of the generic drug industry’s biggest critics of poor quality at Indian drugmakers, had “significant violations" of manufacturing-quality rules at three plants in India, US regulators said in a warning letter.
The violations include failure to establish and follow written procedures to prevent microbiological contamination, use of torn gloves, poor monitoring to ensure a contamination-free environment and a failure to investigate product complaints, according to the warning letter from the Food and Drug Administration dated 6 August.
Mylan is in the middle of trying to close its biggest-ever deal, a $33 billion acquisition of Perrigo Co. The company, whose executives are based in Canonsburg, Pennsylvania, has operations around the world and has pushed for tougher US inspections in India and other foreign countries. Mylan chief executive officer Heather Bresch has called stricter enforcement abroad imperative to ensure access to quality drugs in the US.
A Mylan spokeswoman didn’t immediately comment on the warning letter. Mylan shares rose less than 1% to $55.86 at 10:28am in New York.
Two of the plants cited by the FDA were acquired in Mylan’s 2013 acquisition of Agila Specialties, a unit of Indian drugmaker Strides Arcolab Ltd. Bresch said last year Mylan was working to bring the Agila plants up to code after quality problems were found.
India inspections
The inspections at the Mylan plants were conducted in August and September of 2014 and February of this year. The FDA said in the letter Mylan has 15 working days to respond and take corrective action or the FDA can withhold approval of new drug applications and refuse admission of products into the US.
In an with Bloomberg this month, Bresch said that “as the FDA steps up their efforts in countries like India and China, we’ve continued to say that will continue to allow us to distinguish ourselves."
Mylan had 21 plants in India at the end of 2013. Last year, Bresch said Mylan’s drugs shouldn’t be lumped in with those made by India-based companies. Mylan has a “one-quality" standard, meaning that it holds its factories in India to the same standard as its US facilities, she said in a February 2014 interview.
At the time, she also predicted trouble ahead for India- based firms.
“It’ll get worse before it gets better," Bresch said. As regulators boost inspections there, consumers will see “more market disruption, more companies being shut down, more bans on facilities," she said. “I’d be shocked if there’s not."
The FDA has banned drugs from more than 30 plants in India since 2013, after the agency boosted inspections using fees it charges drugmakers to review their products.
Mylan investors are set to vote on the Perrigo deal 28 August. Perrigo has said that Mylan’s offer undervalues the company, and urged shareholders to reject it. Bloomberg
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