FDA Documents Show India Labs Omitted Results of Drug Purity Test

A November 2013 Food and Drug Administration (FDA) document obtained by Bloomberg News shows that in 2011, a quality-control employee of Sun Pharmaceutical Industries Ltd. deleted the results of a failed drug purity test. When a drug is shown to contain a certain level of impurity, the entire batch is supposed to be thrown out.

The document showed that instead, the failed results were deleted. Workers tested a different sample from the same batch the next day and passed the batch. As a result, that batch was determined to be clean and was prepared to ship overseas to the US. An additional 5,301 chromatography test results were deleted at the facility, the FDA’s computer forensics experts found.

“Our review found that analysts regularly delete undesirable chromatographic results, and products are retested without initiating an investigation as required,” agency inspectors stated in the document. The incident “raises concerns about the integrity of all data generated by your firm,”

Sun Pharmaceutical isn’t the only manufacturer that has been deleting test results, Bloomberg reports. FDA documents indicate that dozens of other plants in India have taken similar actions on quality tests, according to Live Mint. Cleveland Clinic cardiologist Harry lever said “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?”

Additionally, it appears that some companies have failed to report issues altogether. At least a dozen companies are accused of failing to report data from safety and efficacy tests. These companies all have facilities in India that were banned from exporting drugs to the US last year.

India mainly manufactures generic medications, and is the second largest drug exporter to the United States. Pharmaceuticals that are imported are not required to be tested. The facilities themselves are relied upon to perform quality tests and report accurate results. The agency only does its own testing when there are a significant number of complaints about a product.

FDA spokeswoman Tara Goodin said “The agency has about a dozen staff members in India to police about 600 factories registered there with the US This year, the FDA had conducted 97 inspections of drug manufacturers as of the end of October,” Live Mint reports.

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