FDA Walks the Walk On Ranbaxy Quality Issues

The Ranbaxy soap opera continues. Last month, we profiled the generics maker's recent triumphs and travails. Now, under mounting concerns over the quality of Ranbaxy HIV and other medications, FDA has halted imports of more than 30 drugs originating in two of the company's Indian facilities, one in Dewas and one in Paonta Sahib.

The affected drugs include generic forms of several industry blockbusters: simvastatin (Zocor), pravastatin (Pravachol), ciprofloxican (Cipro), gabapentin (Neurontin), and loratadine (Claritin). FDA pledges that the action should not create any shortages of these drugs in the U.S. market.

The Agency has said the move is "proactive," and that it has no evidence the company has shipped defective products. "We are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality," says CDER director Janet Woodcock. Some see the move as a reaction to Congressional pressure for FDA to get tougher with Ranbaxy. The Indian company is also under investigation by the Justice Department over whether or not it produced substandard HIV medications for the African market. 

FDA's letter to CEO Malvinder Singh regarding the Dewas facility includes a laundry list of varied quality control concerns:

• QC personnel move about freely between manufacturing areas for different products, and between warehouses and other parts of the campus
• Batch records were moved freely between manufacturing areas and adminstrative buildings
• Personnel moved about with API powder on their gowns and interacted freely with bulk bags and transport equipment
• Contamination control and monitoring programs and records are inadequate
• The site failed to properly investigate sterility failures and other issues

The Agency's letter regarding Paonta Sahib focused primarily on recordkeeping inadequacies.

Stay tuned . . . 

--PWT