Dr Reddy's Labs fined by FTC for non-compliance

The US Department of Justice announced on Friday that a federal court in New Jersey has imposed a $5 million civil penalty and entered a consent decree of permanent injunction against the US subsidiary of India’s Dr Reddy’s Laboratories (BSE: 500124).

The case involves allegations that Dr Reddy’s failed to comply with the Poison Prevention Packaging Act (PPPA) and the Consumer Product Safety Act (CPSA). Under the terms of the consent decree, Dr Reddy’s will implement a compliance program designed to ensure compliance with the PPPA and the CPSA.

The Department filed a complaint in the District of New Jersey on December 18, 2017 on behalf of the Consumer Product Safety Commission (CPSC). As alleged in the complaint, Dr Reddy’s knowingly violated 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, despite being previously warned by its own employees that the blister packs had not been tested for PPPA compliance and that certain blister packs were expected to fail the PPPA’s child test protocol.