Drug Imports from India Blocked by FDA

September 2008

The Food and Drug Administration (FDA) has issued an "important alert" to stop about 30 generic drugs manufactured in India from being imported into the United States. The FDA says that the drugs, which include the generic versions of the antibiotic Cipro and the cholesterol medication Zocor, were made in subpar manufacturing conditions.

The potentially dangerous medications were produced at two plants, Dwas and Paonta Sahib, which are owned by India’s largest pharmaceutical company, Ranbaxy. The FDA learned about possible problems at the plants in August 2005 and inspected them earlier this year. According to the agency, their inspection found "extensive deviations" from good manufacturing practice requirements, including inaccurate records of the cleaning and operation of equipment. These violations could lead to drug contamination, allergic reactions, and other negative side effects.

The FDA said it would not approve any new products for sale by Ranbaxy until the manufacturing violations are fixed. Ranbaxy has plants in 11 countries, including three in the United States. Ranbaxy’s facilities in New Jersey and New York make 59 drugs, including Simvastatin, Acyclovir, Minocycline, Clindamycin, Lorazepam, Loratadine-D, Cetirizine, Acetaminophen Extended release tablets, Lisinopril and Zolpidem.