FDA castigates India's Emcure for routinely faking data

The other shoe has dropped for an Emcure Pharmaceuticals plant in India. After banning most of the sterile products coming out of the plant last year, the FDA has now issued a warning letter that says the company routinely used "fraudulent" test data to move drugs through the manufacturing process.

The letter, issued March 3 but posted Tuesday by the FDA, gave Emcure some credit for bringing in consultants, changing some procedures and retraining employees. The agency pointed out, however, that it has been warned before about some of the issues that put into question the sterility of its injected drugs.

A two-year review of records at the plant in Hinjawadi found big problems in environmental monitoring. It says Emcure itself acknowledged "there have been serious gaps in the management, oversight and execution of the environmental monitoring program, especially with respect to the suspected data integrity and falsification of data concerns."

In one example, an Emcure microbiologist told investigators that because of "work pressure" they often labeled media plates and put them into incubation even though they had never actually been exposed to the environment. During its inspection, FDA reviewers found three dozen media plates that were suspect.

In the aseptic filling area, investigators noted practices that put the drugs in danger of contamination. One operator retrieved a lid dropped on the floor and put it back into a vial. Some didn't wear protective gloves while working around sterile drugs. One piece of machinery required operators to crawl under the filling line on their hands and knees to perform a function. That left the FDA to surmise that the facility design is a problem.

The first indication of problems at the Emcure plant arose last year when Teva Pharmaceutical ($TEVA) had to recall nearly 40,000 drugs manufactured for it by Emcure at the plant in Hinjawadi. The products were recalled for "deviations in lab testing." A couple of months later, the FDA put the facility on its import alert list, banning all but 9 of its products. Those excluded included cidofovir, a generic of Gilead Sciences' ($GILD) Vistide, which is used to treat eye infections in people with AIDS, as well as the antipsychotic haloperidol and cancer drug carmustine.

The kinds of data deviations at the plant, in which companies manipulate drug testing analysis to get the results needed to approve batches, has led the agency to ban a long list of manufacturing facilities in India.

In January, it was reported that Emcure had acquired Canada-based International Pharmaceutical Generics and its marketing operation Marcan Pharmaceuticals. Analysts and experts have noted that a number of Indian companies have been buying manufacturing assets in North America, which they believe will be more likely to have and maintain FDA GMP standards and allow them to make more complex drugs.

- read the warning letter

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