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FDA Issued Warning Letter to Cadila Healthcare

Company becomes latest Indian firm to fail to comply with U.S. standards

by Jean-François Tremblay
January 7, 2016 | A version of this story appeared in Volume 94, Issue 2

Credit: FDA
Recent recipients of FDA warning letters in India include prominent local and foreign firms. NOTE: List is not comprehensive. SOURCE: FDA
A table of Indian drug companies that received FDA warning letters in 2015
Credit: FDA
Recent recipients of FDA warning letters in India include prominent local and foreign firms. NOTE: List is not comprehensive. SOURCE: FDA

Cadila Healthcare, a major Indian generic drug company, has become the latest pharmaceutical manufacturer with a plant in India to be issued a U.S. FDA warning letter for failing to meet the regulatory standards of the U.S.

Warning letters are issued to firms that, during an inspection by FDA officials, are found to breach pharmaceutical manufacturing regulations. Recipients of the letters are often, but not always, banned in the U.S. from selling finished drugs and active ingredients made at their noncompliant facilities.

In a statement to the Bombay Stock Exchange, Cadila acknowledged receiving a warning letter covering two plants, one making active pharmaceutical ingredients and the other formulations. The firm did not say what violations were alleged, and FDA hasn’t released the letter.

Other prominent Indian drug firms have received warning letters in the past year. The list includes Sun Pharmaceutical Industries, which is India’s largest drug manufacturer, and Dr. Reddy’s Laboratories. FDA also issued warning letters last year detailing flaws at Indian plants owned by U.S.-based Mylan and the Swiss generic drug producer Sandoz.

The FDA letters cite a range of shortcomings at Indian plants. In many cases, such as the most recent letter issued to Sun, companies are accused of failing to maintain proper records, a deficiency that impedes inspectors’ efforts to determine if required manufacturing procedures are followed. At other companies, such as Pan Drugs, inspectors saw facilities so poorly maintained that pigeons roamed inside.

Top managers at some Indian drug firms pursue profitability as their main objective even if it comes at the expense of quality, claims Helena Champion, principal consultant at Drug Quality Assurance, a Boston-based drug manufacturing quality and regulatory compliance firm. The managers flout the rules because “poor- or unsafe-quality product is not likely to be discovered and attributed to their company.” Rather, she says, many reckon that the U.S. buyers and distributors of their products will be blamed for any quality problems.


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