Drugs manufactured at the Indian plant of Canadian generics giant Apotex came under fire from regulatory experts this week after health concerns were sparked by the revelation that the company sold prescription drugs that it knew were defective.
Records published by the U.S. Food and Drug Administration (FDA) regulator show that in June this year Apotex employees at a facility in Bangalore that makes drugs exported to North America “did not report undesirable test results and doctored bacterial growth test records.”
Despite the FDA sending warning letters to Jeremy Desai, the President and Chief Operating Officer of Apotex, “drugs and drug ingredients banned from the U.S. market have been allowed by [the Canadian regulator] Health Canada into Canadian pharmacies,” reported The Star newspaper.
The furore over sub-standard drugs making their way into the Canadian market comes in the wake of multiple import bans issued by the FDA against Indian generics firms, the most notable example being Ranbaxy.
In May 2013, eight years after whistleblower and former Ranbaxy Director Dinesh Thakur brought what appeared to be widespread falsification of drug testing data to the notice of the FDA, Ranbaxy pleaded guilty to seven criminal charges linked to manufacturing fraud and coughed up $500 million in fines.Problematic approval
This week’s concerns surrounding Apotex appeared to cast doubts upon the quality control processes of other regulators too, and the newspaper noted, “During one of those rare visits outside the country, Health Canada inspectors went in February to an Apotex facility in Bangalore that produces finished drug products.”
However while Health Canada gave a “thumbs up” for Apotex’s three factories in Bangalore, all producing drug ingredients and finished drugs in the same industrial park, FDA inspections at the same sites seven months before the Canadian one and again four months after it, uncovered “blatant and repeat problems at the plant.”
Among the violations of current Good Manufacturing Practices, or cGMP, discovered were instances of an Apotex quality control microbiologist overwriting documents on bacterial contamination tests “using a black marker in order to make it appear that the growth promotion testing had been performed” on an earlier date; 500 power outages noted during the span of one year, which could have affected quality tests of drugs; and numerous cases of Apotex employees retesting drug products when the first test yielded “unknown impurities” and then not reporting the undesirable results.