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Indian drug major’s Laboratories Limited has reached a settlement with the US government agencies for $5 million in a six-year-old case regarding complaints of potential harm from the package of blister-packed prescription products to children. In June last year, US Consumer Product Safety Commission(CPSC) has requested the US Department of Justice to impose civil penalty on Dr Reddy’s for alleged violations of provisions related to child-resistant packaging in at least five prescription drugs. While disagreeing with these allegations, the company on Tuesday said it had chosen to settle the matter in order to avoid any unnecessary costs and the distractions of prolonged litigation. In a joint filing by the parties, Dr Reddy’s and the US Department of Justice agreed to the settlement of the action without any adjudication of any issue of fact or law. In an investigation conducted between 2008 and 2012, the US CPSC held that the company sold prescription drugs having unit dose packaging that failed to comply with its special child resistant packaging regulations and failed to issue general certificates of conformance. Subsequently in June 2016, the commission voted 4-1 against Dr Reddy’s for not reporting the risks under the provisions of Consumer Product Safety act and Poison Prevention Packaging Act. “Dr Reddy’s has taken this investigation seriously, cooperating with the government over the past six years.
The safety of patients and consumers is of paramount importance to Dr Reddy’s and the company firmly disagrees with the government’s allegations,” the company said.