A federal court in the US today imposed a USD 5 million civil penalty on the North America subsidiary of India’s Dr Reddy Laboratories for distributing prescription drugs in blister packs that were not child resistant, the Department of Justice said.
“Dr Reddy’s failed to ensure that children were protected from potentially harmful prescription drugs,” said Acting Assistant Attorney General Chad A Readler of the Justice Department’s Civil Division.
The court in New Jersey imposed the fine after a complaint that Dr Reddy Laboratories (DRL) failed to comply with the Poison Prevention Packaging Act (PPPA) and the Consumer Product Safety Act (CPSA).
“Child-resistant packaging is a critical safety measure put in place to protect our country’s children,” said CPSC Acting Chairman Ann Marie Buerkle.
In addition to the USD 5 million civil penalty, the consent decree generally enjoins DRL from distributing household oral prescription drugs in violation of the PPPA and CPSA.
The injunction further requires DRL to maintain internal controls and procedures designed to ensure timely, truthful, complete and accurate reporting to the Consumer Product Safety Commission (CPSC) as required by law.
Under the terms of the consent decree, DRL will implement a compliance programme designed to ensure compliance with the PPPA and the CPSA.
The Department of Justice filed a complaint in the District of New Jersey on December 18, 2017 on behalf of the Consumer Product Safety Commission.
It was alleged that DRL knowingly violated the CPSA with respect to household oral prescription drugs in blister packs that were not child resistant as required by the PPPA.
According to the complaint, DRL distributed such prescription drugs until 2012, despite being previously warned by its employees that the blister packs had not been tested for PPPA compliance and that certain blister packs were expected to fail the child test protocol.
In addition, the complaint alleged that DRL failed to notify the CPSC “immediately”, as required by law, that its products were not compliant with the PPPA, that the products contained a defect presenting a substantial product hazard, and that the products created an unreasonable risk of serious injury or death.
It alleged that DRL failed to certify that its products were in conformance with the PPPA.
In agreeing to settle this matter, DRL has not admitted that it violated the law.