The United States Consumer Product Safety Commission (US CPSC), a federal regulatory body in the US has charged Dr. Reddy’s labs, a drug-maker based in Hyderabad of violating provisions related to child resistant drug-packaging and has on Wednesday approached the US Department of Justice to impose a civil penalty against the drug manufacturer citing the violation of norms.
The US CPSC is a federal agency, whose duty is to protect children and family from risks of injuries or death associated with consumer products. According to its norms, a product (drug) considered to be poisonous or harmful in nature and being sold in the US market must be packed as per the guidelines laid down by the commission. The charges against Dr Reddy’s comes after the CPSC’s investigations into several drugs, not following the packaging norms.
The review of the federal agency on Dr Reddy’s said that the Hyderabad based manufacturer has failed to comply with its guidelines on five prescriptions drugs. The guidelines requires the manufacturer to state the risks of using a product and also to highlight “POISON” on the package, if the substance being sold is poisonous.
Of the global sales of $2.33 billion for 2016 financial year, Dr. Reddy’s drew $1.16 billion from its North American operations, of which the US accounted for the lion’s share, as per the Economic Times.
In response to the US CPSC’s move, s spokesperson from Dr Reddy’s said “We strongly disagree with the US government’s allegations. We always followed the local norms in every country. However, we will continue to offer our support to the US government in all its investigations”.
“I would also like to add that the we have not received any input or reports from the US government stating that a child or any other citizen has been affected or gained access to our products as a result of packaging error. Dr Reddy’s always make sure that it follows international standards while preparing and packaging its products and will continue do so in the future as the safety of patients and consumers is of paramount importance to us”, he added.