India based generic pharmaceuticals producer Ranbaxy is once again under U.S. Federal Drug Administration (FDA) scrutiny after a visit inspection of a northwestern India production facility. The FDA banned from the U.S. market the use of drug ingredients originating from Ranbaxy’s Toansa India facility.
Readers residing in pharmaceutical supply chains are probably quite familiar with Ranbaxy and its ongoing challenges in insuring adherence to good manufacturing practices. As far back as 2008 the FDA of more than 30 generic type drugs manufactured by the India based drug maker, one of the world’s significant producers of generics. In 2012, the FDA initiated increased regulatory powers forcing Ranbaxy to halt production of the generic of the highly prescribed cholesterol drug Lipitor while it investigated tiny glass particles found in production batches and other discrepancies. That resulted in a consent decree involving the U.S. Justice Department requiring the company to take steps to insure the integrity of production at three production plants within India.
Now there are reports that on a recent FDA inspection visit, Ranbaxy workers at the Toansa India facility were discovered to be repeatedly altering test results to make it appear that active pharmaceutical ingredients (API) met required standards when they didn’t. According to a Wall Street Journal report, FDA inspectors discovered workers retesting “until acceptable results are obtained” and “deleting evidence of failed tests.” Inspectors were also reported as finding significant disrepair at the plant’s analytical and microbiology laboratories with windows that could not close and a sample preparation room laden with flies. Inspectors also reported to have found evidence of backdating lab results.
The WSJ also characterized this latest action as a serious blow since the Toansa facility supplies many critical ingredients used in Ranbaxy’s generic drug manufacturing including fenofibrate, a drug used to reduce fatty acids in blood to boost good cholesterol as well as valacyclovir which is used to treat shingles and genital herpes. Japanese drug maker Daiichi Sankyo, which now owns upwards of 60 percent of Ranbaxy has dispatched experts to India to help in determining a solution to the ongoing situation.
While these latest actions add more challenges for Ranbaxy and its new owner Daiichi Sankyo, it could add further impacts to already stressed generic drug supply chains. Increased health insurance scrutiny and subsequent regulations on the part of multiple governments has added increased pressures on the industry and generic drug manufacturers, under constant pressure for reduced pricing and more supply.