FDA Bans Importation of 28 Drugs from Indian Drugmaker

By Jenny Huntington
19:42, September 30th 2008
38 votes
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FDA Bans Importation of 28 Drugs from Indian Drugmaker

The Food and Drug Administration has banned the importation of 28 drugs made by giant Indian drugmaker Ranbaxy Laboratories, due to shortcomings in the manufacturing process at two of the producer’s plants.

Nevertheless, since there was no proof that those drugs might be harmful to people taking them, the FDA stated that they had only made the decision in order to prevent any undesired effects on patients from occurring.

Federal health officials have sent two letters to Ranbaxy so far, warning the company that they had some manufacturing issues including sub-par sterile processing operations.

Moreover, they informed that at the two plants, the records were poorly kept and also that various areas were contamined with allergy-causing compounds.

The 28-drugs list features medications for high cholesterol, high blood pressure, acne, seasonal allergies, diabetes, along with many antibiotics and antivirals. Of the latter, the most commonly known is AZT, an antiretroviral drug that can reduce the risk of an HIV infection, also being used to prevent mother-to-child transmission of the aforementioned virus.

The FDA informed people taking the drugs manufactured by the Indian company that there was no need to cease the treatment.

Ranbaxy Laboratories, India’s largest pharmaceutical company, ranks among the top ten drug manufacturers worldwide, with their products being exported to approxomately 125 countries.

The company entered the United States in 1998 and in 2005, the U.S. market was reported to have accounted for 28% of the drugmaker’s sales.



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