The US Consumer Product Safety Commission late last month voted to ask the US Department of Justice to seek civil penalties against Dr. Reddy’s Laboratories, one of India’s largest drug makers, for failing to report problems with packaging for several medicines.
In a 4-1 vote that was held two weeks ago, the safety agency determined that the company knowingly violated federal law because issues with child-resistant blister packs for five prescription drugs were not reported within the mandated 24 hours, according to a CPSC spokesman. The violations allegedly occurred between 2002 and 2011, according to a regulatory filing by the drug maker. Dr. Reddy’s disclosed the CPSC vote this week.
Although there a few recalls each year involving packaging violations, the CPSC spokesman noted that this case is different because it been referred to the Justice Department. The allegations, though, have been dogging Dr. Reddy’s, a big supplier of generic drugs around the globe, for several years. Both the CPSC and the Justice Department began probes in 2012, following claims made in a whistleblower lawsuit filed by two former marketing directors.
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