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


 

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  • <p class="MsoNormal"> I am sure the deficiencies of the Ranbaxy plants will be remedied. </p> <p class="MsoNormal"> However, the US FDA citations should be considered a positive wake up call and an opportunity for Ranbaxy and rest of the Indian pharmaceutical companies. Only way they should rest easy is exceed any and every global standard. They have to take that extra step, walk the extra mile to establish and exceed the toughest standards. In fact, they could use the opportunity to establish a higher standard that could become a showpiece of the industry. </p> <p class="MsoNormal"> It is not going to be costly and/or a monumental effort to get to a higher plateau. It just takes resolve to get there. Economically it isnot expensive and the return on investment will be significantly better at the higher standard. Customer will be pleased when their quality demand isexceeded. They will always come back even at a higher price. </p> <p class="MsoNormal"> While Ranbaxy is setting up to meet and/or exceed FDA standards, they and the other Indian pharmaceutical companies should consider producing single specification active pharmaceutical ingredient (API) and formulated product for every market rather than multiple specification API and products for different markets. It will simplify their manufacturing, reduce costs and would take away every bit of laxity, as they will have only one standard tofollow.  </p> <p class="MsoNormal"> Ranbaxy and other Indian pharmaceutical companies have to keep in mind that since 2005 they are catering to a much larger customer base. Their job would be simplified and will be cost effective if they catered every market with one formulated product rather than multiple formulated products using multiple specifications API.  </p> <p class="MsoNormal"> If the formulation processes were converted from a batch process to a continuous process, which would be definitely feasible when using single spec API and excipients, many of the problems could be self corrected, as product uniformity would be there. Costs would be lower than a corresponding batch process.  </p> <p class="MsoNormal"> These steps will simplify their total business process, inventory management, manufacturing methods and processes giving them higher profitability. Savings due to these steps would give the Indian companies an unprecedented competitive advantage.  </p> <p class="MsoNormal"> Girish Malhotra </p>

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