A federal court in New Jersey on Friday slapped a penalty of $5 million on Dr. Reddy’s Laboratories Inc. and forced the pharmaceutical company to enter consent decree of permanent injunction after it allegedly distributed prescription drugs in packages that are not child-resistant.
The judgment came after Dr. Reddy’s Laboratories Inc., the American subsidiary of Indian multinational pharmaceutical company based in Hyderabad, was found violating the US Poison Prevention Packaging Act (PPPA) and the Consumer Product Safety Act (CPSA).
Dr. Reddy’s, by entering the consent decree will now have to implement a compliance program designed to ensure compliance with the PPPA and the CPSA.
According to the prosecution, packs of Dr. Reddy’s oral drugs were found to be not child-resistant as required by the PPPA.
It alleged that the company had been distributing such prescription drugs till 2012, despite previous warnings explaining the consequences of the malpractices that were expected to fail the PPPA’s child test protocol.
The complaint said that the firm, despite knowing that they have fielded medicines that are not compliant with PPPA, failed to inform CPSC “immediately” as they are likely to cause risk of serious injury or death. The complaint said Dr. Reddy’s also failed to certify that its products were in conformance with the PPPA.
“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 government will continue to take seriously alleged violations of laws meant to protect consumer safety.”
“Child-resistant packaging is a critical safety measure put in place to protect our country’s children,” said CPSC Acting Chairman Ann Marie Buerkle. “I appreciate and value the support from and collaboration with the Department of Justice.”
The consent decree has asked Dr. Reddy’s to mandatorily implement a compliance program and call back all medicines that failed the compliance program.
The injunction further requires Dr. Reddy’s to maintain internal controls and procedures designed to ensure timely, truthful, complete, and accurate reporting to the CPSC as required by law.
Even though Dr. Reddy’s has agreed to settle the case, it has not admitted to doing any violations.