BANGALORE: The U.S. Food and Drug Administration declared that Indian generic drug maker Dr. Reddy’s Lab is voluntarily recalling a batch of heartburn drug lansoprazole due to microbial contamination.
The FDA website reports Dr. Reddy’s Lab started recalling about 58,656 bottles of lansoprazole since 3rd January 2014. The recall is classified as ‘Class-II’ recall-a tag reserved for flawed manufacturing practices that could lead to adverse consequences and in extreme cases, death.
According to a recent report, the U.S. FDA has imposed an import ban on drugs manufactured at the Karkhadi plant of generic drug maker Sun Pharmaceuticals.
Few years back, Ranbaxy had pleaded guilty to charges of drug adulteration. The list of Indian pharmaceutical companies, facing the heat of the U.S.FDA now includes- Sun Pharmaceuticals, RPG Life Sciences, Agila Specialities, Ranbaxy, Wockhardt and Dr. Reddy’s Lab.
India is the second largest exporter of drugs to the U.S. market after Canada and the U.S. provides the largest market for Indian drug manufacturers. India supplies 40 percent of drugs consumed by the U.S. market.
There’s a perception in India that the U.S. FDA is unfairly acting tough on Indian pharmaceuticals and this point was raised with the US FDA Commissioner Margaret Hamburg when she visited India in February.
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