packagingBy Lalit K JhaWashington, Jan 19 (PTI) A federal court in the US todayimposed a USD 5 million civil penalty on the North Americasubsidiary of India's Dr Reddy Laboratories for distributingprescription drugs in blister packs that were not childresistant, the Department of Justice said.
"Dr ReddyÂ’s failed to ensure that children were protectedfrom potentially harmful prescription drugs," said ActingAssistant Attorney General Chad A Readler of the JusticeDepartment's Civil Division.
The court in New Jersey imposed the fine after acomplaint that Dr Reddy Laboratories (DRL) failed to complywith the Poison Prevention Packaging Act (PPPA) and theConsumer Product Safety Act (CPSA).
"Child-resistant packaging is a critical safety measureput in place to protect our country's children,” said CPSCActing Chairman Ann Marie Buerkle.
In addition to the USD 5 million civil penalty, theconsent decree generally enjoins DRL from distributinghousehold oral prescription drugs in violation of the PPPA andCPSA.
The injunction further requires DRL to maintain internalcontrols and procedures designed to ensure timely, truthful,complete and accurate reporting to the Consumer Product SafetyCommission (CPSC) as required by law.
Under the terms of the consent decree, DRL will implementa compliance programme designed to ensure compliance with thePPPA and the CPSA.
The Department of Justice filed a complaint in theDistrict of New Jersey on December 18, 2017 on behalf of theConsumer Product Safety Commission.
It was alleged that DRL knowingly violated the CPSA withrespect to household oral prescription drugs in blister packsthat were not child resistant as required by the PPPA.
According to the complaint, DRL distributed suchprescription drugs until 2012, despite being previously warnedby its employees that the blister packs had not been testedfor PPPA compliance and that certain blister packs wereexpected to fail the child test protocol.
In addition, the complaint alleged that DRL failed tonotify the CPSC "immediately", as required by law, that itsproducts were not compliant with the PPPA, that the productscontained a defect presenting a substantial product hazard,and that the products created an unreasonable risk of seriousinjury or death.
It alleged that DRL failed to certify that its productswere in conformance with the PPPA.
In agreeing to settle this matter, DRL has not admittedthat it violated the law. PTI LKJPMS.
This is unedited, unformatted feed from the Press Trust of India wire.