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U.S. Court Imposes Fine on Dr. Reddy’s Labs For Flouting Safety Protocols

The American branch of the Indian pharmaceutical company Dr. Reddy’s Labs was fined $5 million by a federal court in New Jersey.

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A federal court in New Jersey, United States, has fined the American branch of Indian company Dr. Reddy’s Laboratories Inc. for $5 million in a civil penalty case. The court told the company to not repeat its violation in packaging, the U.S. Department of Justice said. Dr. Reddy’s has not admitted that it violated the law.

The Indian-origin company failed to comply with the Poison Prevention Packaging Act (PPPA) and the Consumer Product Safety Act (CPSA), the Justice Department said in a statement on Jan. 19. Under the terms of the consent decree, Dr. Reddy’s will implement a compliance program designed to ensure compliance with the two acts.

“Dr. Reddy’s failed to ensure that children were protected from potentially harmful prescription drugs,” Chad A. Readler, the Acting Assistant Attorney General of the Justice Department’s Civil Division, said. “The government will continue to take seriously alleged violations of laws meant to protect consumer safety.”

Dr. Reddy’s was said to knowingly violate the CPSA with respect to household oral prescription drugs in blister packs that were not child resistant as required by the PPPA. As set forth in the complaint, Dr. Reddy’s distributed such prescription drugs until 2012, even though it was warned by its own employees that the packs were not tested for PPPA compliance and that certain blister packs were expected to fail the PPPA’s child test protocol.

In the complaint, it was also alleged that Dr. Reddy failed to notify the Consumer Product Safety Commission (CPSC) “immediately,” as required by law. Ideally, the firm should have informed 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. They reportedly also failed to certify that the products conformed to the norms of the PPPA.

“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.”

According to the consent decree, Dr. Reddy’s has to maintain internal controls and procedures designed to ensure timely, truthful, complete, and accurate reporting to the CPSC as required by law.

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