Food and Drug Administration documents obtained through a Freedom of Information Act (FOIA) request indicate that in 2011 a quality-control employee Sun Pharmaceutical Industries Ltd., an Indian generic drug manufacturer, deleted results of failed purity tests on drugs intended for shipment to the US.
A batch of a drug that fails a purity test is supposed to be discarded but in this case, the failed tests were deleted from the records and the next day workers entered passing results from another sample, Bloomberg News reports. The information was contained in a November 2013 FDA document obtained through a Freedom of Information Act (FOIA) request. The name of the drug was redacted. Records indicate that FDA computer forensics experts eventually uncovered 5,301 additional deleted results from tests at the Sun facility. In a May warning letter to Sun Pharma, FDA officials told the company the incident “raises concerns about the integrity of all data generated by your firm.”The data-integrity problem extends beyond Sun Pharma. FDA inspection documents and warning letters reveal that at least 12 Indian drug companies are accused of failing to report data from safety and efficacy tests. The FDA has banned some companies exporting their drugs to the US. India is the second-largest drug exporter to the US. Indian companies supply many generic drugs and the active ingredients for medicines manufactured in the US, The Mint reports (livemint.com). Manufacturers are responsible for conducting the necessary quality tests; the FDA conducts such tests only when it receives complaints about a drug, Livemint reports.
In response to growing concerns about the quality and safety of Indian drugs, FDA Commissioner Margaret Hamburg visited India in February. She vowed to help companies improve compliance. She also pledged to increase FDA personnel in India to 19, though staffing remained at 12 as of the end of October, according to Livemint.