The US subsidiary of Indian drug major Dr Reddy’s laboratories has reached a settlement with the US Department of Justice (DOJ) in more than a six-year-old case, involving packaging for five blister-packed prescription products.
The firm has agreed to pay $5m to settle the matter although it says it firmly disagrees with the US government's allegations.
Dr. Reddy’s and the DOJ agreed to the settlement of the action without any adjudication of any issue of fact or law.
“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. However, in order to avoid any unnecessary costs and the distractions of prolonged litigation, the company h as chosen to settle the matter for $5m,” Dr Reddy’s said in a statement.
Furthermore, the drug company said that it was not aware of any reports that any child gained access to these products as a result of the packaging or that any of the products caused children harm as a result of the packaging.
However, these products have not been distributed in the packaging at issue since June 2012, the company said.
Hyderabad-based Dr. Reddy’s added that it is committed to complying with all applicable requirements of the Consumer Product Safety Act, including applicable packaging and reporting requirements.