New FDA Warning Letters Show India’s Drugmakers Still in Trouble
The latest regulatory crackdown shows U.S. regulator’s stance is hardening toward lapses in quality control.
(Bloomberg) -- Three major Indian drugmakers received warning letters from the U.S. health care watchdog in the last two months, highlighting that the country’s copycat drug sector is still plagued by quality issues amid rising global concern over tainted drug supplies.
Cadila Healthcare Ltd., Glenmark Pharmaceuticals Ltd. and Lupin Ltd. are the latest local medicine makers to be reprimanded by the U.S. Food and Drug Administration, exchange filings show. A plant with a warning letter is barred from introducing new products in the U.S., stymieing the company’s ability to grow revenue in the world’s top pharmaceutical market.
The latest regulatory crackdown shows U.S. regulator’s stance is hardening toward lapses in quality control even as it seeks cheaper drugs to contain health care costs. Indian pharmaceutical factories collectively produce about 40% of the American generic drug supply and have been faulted in the past by the FDA for everything from lax documentation to open toilet drains and malfunctioning equipment.
The FDA is struggling to contain the damage after carcinogenic chemicals were discovered in generic drugs to control blood pressure and stomach acid, prompting drug makers in India and elsewhere to recall the medicines.
Cadila Healthcare received a warning letter against its Moraiya facility in the western state of Gujarat, it said in a Nov. 4 filing, about three years after a previous warning letter against this plant was lifted.
Glenmark told exchanges in October that its manufacturing site in Baddi in Himachal Pradesh has got a similar letter, without elaborating on the reasons for this regulatory action. Lupin informed investors Sept. 19 that its Mandideep plant had also got a warning letter. The US FDA said it had found similar quality control lapses at Lupin’s two other sites too.
To contact the reporter on this story: Ari Altstedter in Mumbai at aaltstedter@bloomberg.net
To contact the editors responsible for this story: Rachel Chang at wchang98@bloomberg.net, Bhuma Shrivastava, Anto Antony
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