FDA News

FDA Bans 28 Drugs Made By Indian Drug Manufacturer

-InjuryBoard.com

09/30/2008- The Food and Drug Administration (FDA) is halting the importation of twenty-eight drugs made by Ranbaxy Laboratories, a giant Indian generic drugmaker, due to deficiencies in manufacturing at two of the company’s plants. A physician with the FDA, however, said there was no evidence that drugs coming from the plants in question could harm consumers; the ban was more of a preventive action. FDA officials have even insisted that patients continue taking medications because none have been found to be contaminated or unsafe.

The FDA sent two warning letters, the first being in 2006, warning Ranbaxy that there were problems with the manufacturing process. For example, the drug manufacturer had "inadequate sterile processing operations", failed to keep particular areas from being contaminated with compounds that can cause allergic reactions in some people and kept inadequate records. Because the plants are on foreign soil, however, the FDA has no direct regulatory control over them so their only leverage is to ban imports.

Some of the drugs on the list include numerous antibiotics and antivirals, along with medications for high cholesterol, high blood pressure, acne, seasonal allergies and diabetes. One of the most recognizable drugs included is the antitretroviral AZT. Since all of the drugs, except for the antiviral drug ganciclovir, are made by other companies, a shortage to U.S. consumers is not expected.