Court fines Dr Reddy’s for improperly packaging products

pharmafile | January 22, 2018 | News story | Sales and Marketing Dr Reddy's, biotech, drugs, pharma, pharmaceutical 

On 18 December 2017, the District of New Jersey filed a complaint against Dr. Reddy’s Laboratories for failing to comply with the Poison Prevention Packaging Act (PPPA) and the Consumer Product Safety Act (CPSA).

Just over a month later, the district court handed down a $5 million penalty and entered a permanent injunction to prevent Dr. Reddy’s from distributing prescription drugs not in child-resistant packaging.

In order to comply with the PPPA and the CPSA, Dr Reddy’s will have to implement a compliance program to make sure it adheres to the stipulations of the two acts.

The case relates to five products that Dr. Reddy’s manufactures and imported into the US (ciprofloxacin, fluoxetine, ondansetron, risperidone, and sumatriptan). The drugs came in individual blister packs and were found to contravene the two acts, in regards to child-resistant packaging standards.

The case alleges that Dr. Reddy’s had conducted tests of the packaging for safety and a risk analysis report produced internally recommended that the packaging be changed as it would fail the child test protocol.

It was noted in the case that the company began developing replacement packaging for the products but did not stop distribution of the product in the uncompliant packaging until 2012, despite the risk analysis report being produced in 2011. It also failed to notify the Consumer Product Safety Commission of its findings.

“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.”

Dr. Reddy’s agreed to settle the case without admitting that it had violated the law.

Ben Hargreaves

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