USFDA approval to Indian companies for hypertension drug raises questions


Cadila Healthcare Ltd and Alkem Laboratories Ltd recently won approvals from the US Food and Drug Administration (FDA) to make generic versions of valsartan – a hypertension drug. Neither company made any of the recalled valsartan, but both were recently been cited by agency inspectors for quality-control failures that echo problems at other drug-makers.
According to reports, workers ignored testing data that showed product flaws, and destroyed records indicating that the drugs were failing key quality measures. The equipment were unclean as well, according to the FDA inspection report.
The workers, reportedly, deleted 2,000 files that appeared to include failing quality-test results. Inspectors also observed flying insects, including mosquitoes and gnats, that were too numerous to count. Despite the array of problems described in the inspection, Alkem’s plant received a clean bill of health.
Cadila received approval from the FDA to sell valsartan combined with another blood-pressure drug, hydrochlorothiazide. About a month later, FDA inspectors tallied a lengthy list of quality concerns at a plant in Ahmedabad that is making that drug combination. Inspectors found that equipment at Cadila’s facility wasn’t cleaned appropriately and that workers ignored signs of impurities, according to reports.