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Greg Webb
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India-based Co. Recalls Generic Lipitor Over a Dosage Mix-up.

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Generic drugs account for roughly 80% of the all the prescription drugs sold in the U.S.   They are reported to have saved Americans close to $200 billion in 2011. We do not typically have a choice, as many health care plans require generic drugs as a cost-saving measure.

Yet, as we are seeing this week, many of these generic drugs, particularly those produced in India, are made in unsanitary and poorly regulated conditions and present risks to those using them. Recently, the Indian company Ranbaxy recalled their generic version of Pfizer’s Lipitor (atorvastatin calcium), a cholesterol medication, after a pharmacist found a 20 milligram tablet in a sealed bottle labeled as containing 10 milligram tablets.

I recently wrote about the growing safety concerns over conditions in India’s pharmaceutical companies, specifically Ranbaxy. Last year the US Department of Justice achieved it’s largest drug settlement to date against Ranbaxy.

Last month, the FDA prohibited Ranbaxy from shipping to the United States any pharmaceutical ingredient made at its Toansa plant in northern India following an inspection that found poor manufacturing practices.
The ban, which followed similar actions at two plants in 2008 and another in September 2013, has triggered scrutiny by FDA counterparts in other countries, including India.

There is significant evidence to question Ranbaxy’s capacity to reliably produce safe medications. And yet, it continues to proliferate the U.S. market with its products. According to CNBC, the company generated 36% of its sales in the U.S. for the quarter ending in December.  “Indian generic drugmakers such as Ranbaxy, Wockhardt and Dr. Reddy’s Laboratories produce nearly 40 percent of generic drugs and over-the-counter products and 10 percent of finished dosages used in the United States.”  The FDA is classifying the recall of generic Lipitor as a Class II recall. That label signifies “a remote chance of severe adverse consequences or death due to the product flaw”. Remote in this case, but Ranbaxy’s last recall, November 2012, involved the same cholesterol-lowering medication, when particles of glass were found in the product.  It ‘fixed’ the problem and has been given the go-ahead to sell its drug in the U.S. again.

We keep hearing that FDA officials plan to tighten the regulations on the generic drug industry. And, in fact, they have shut plants in India, in other countries, and here in the US. But shoddy manufacturing practices and lack of quality controls found in drug manufacturing plants clearly show that the value of profit margins exceeds the desire to produce safe products.  It is an age-old problem, and one that can be corrected by tighter controls and market forces (no one buying poorly made products) .  Hopefully, stricter scrutiny by the FDA will help, at least that is what it hopes will give Americans more confidence in generic drug makers’ products.  So do we.