The US Consumer Product Safety Commission (US CPSC) has approached the US Department of Justice seeking action against Dr Reddy’s Laboratories in a 5-year old case involving packaging for five blister-packed prescription products.
The drugmaker had earlier said the company was under the scanner of the Department of Justice of USA for alleged violations of some provisions of the Consumer Product Safety Act.
In a filing with the US Securities and Exchange Commission, Dr Reddy’s had said the issue pertains to compliance with requirements of special packaging for child resistant blister packs for the products sold by the company in the United States during 2002 and 2011.
“Dr Reddy’s believes that it has complied with all applicable requirements of the Consumer Product Safety Act, including applicable packaging and reporting requirements,” the company said in a statement today.
“However, according to a recent letter from the US CPSC, the Commission has decided to refer the matter to the US Department of Justice, with the recommendation that the Department initiate action,” it said.
“In an investigation conducted by the Department of Justice and concluded in 2015, the Department declined to pursue related allegations made under the Federal False Claims Act. Since the case began in 2011, Dr Reddy’s has cooperated fully with the government and will continue to do so. These products have not been distributed in the packaging at issue since June 2012,” Dr Reddy’s said.
The company, DRL said, has taken this investigation seriously, cooperating with the (US) government over the last five years and will continue to do so.
It added that the safety of patients and consumers is of paramount importance to the company and firmly disagrees with the government’s allegations.
The drugmaker further claimed that it is 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.
The news pulled DRL down stock by 2.02 per cent to Rs 3,069.35 on BSE at 1505 hours.