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FDA Documents Show Indian Lab Deleted Test Results for Drugs Intended for US

Dec 8, 2014

Food and Drug Administration documents show that in 2011 a quality-control employee of Sun Pharmaceutical Industries Ltd., an Indian drug manufacturer, deleted results of failed purity tests on drugs intended for shipment to the US.

When chemical analyses show a certain level of impurities, the whole batch of the drug is supposed to be discarded. But instead, according to Bloomberg News, the results of the failed tests were deleted, and the next day workers entered results from a sample that passed the test, according to a November 2013 FDA document obtained by Bloomberg News. Eventually, FDA computer forensics experts found 5,301 additional deleted results from tests at the Sun facility. “Our review found that analysts regularly delete undesirable chromatographic results, and products are retested without initiating an investigation as required,” inspectors wrote. The incident “raises concerns about the integrity of all data generated by your firm,” the FDA wrote in a warning letter to Sun Pharma in May. Bloomberg obtained the documents through a Freedom of Information Act (FOIA) request, though the name of the drug was redacted.

Similar issues with quality tests have occurred at plants across India and these data integrity breaches worry doctors in the US. They fear that the Indian-manufactured generic drugs may not work as intended, according to “If they make multiple batches, does it come out the same, with the same amount of drug in it? And when you give it to a patient, can you assume it will work consistently?” asked Harry Lever, a cardiologist at the Cleveland Clinic.

A review of FDA inspection documents and warning letters shows that at least 12 drug companies with Indian facilities are accused of failing to properly report data from tests to confirm their drugs safety and efficacy. India is the second-largest drug exporter to the US, mainly producing generic drugs and active ingredients for medicines, Livemint reports. Manufacturers themselves conduct quality tests, with the FDA conducting its own analyses only when it receives complaints about a drug. An FDA spokesperson said the agency has about a dozen staff members in India to monitor nearly 600 facilities registered with US regulators, according to Livemint.

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