Dr. Reddy’s, the Indian generic manufacturer, has been in a world of trouble with FDA and other regulators over improper manufacturing practices, recalls, filing false quality reports and other alleged violations, so it’s probable that the $5-million settlement is relatively low on management’s to-do list. But the resolution highlights a seldom-noticed aspect of pharmaceutical unit-dose packaging: the need to create packages that are both “child proof” and “senior friendly” under guidelines issued by the Consumer Products Safety Commission (CPSC).
In a Dec. 19 announcement, Dr. Reddy’s confirmed a settlement “without any adjudication of any issue of fact or law” and paid a $5-million penalty. The case traces back to 2012, when the CPSC filed a violation of the Poison Prevention Packaging Act for blister-packaged pharmaceuticals that Dr. Reddy’s had been distributing since 2008. In 2016, CPSC referred the case over to the Dept. of Justice. Dr Reddy’s notes that the products involved have not been distributed since 2012, and that there is no record of a child having been harmed by the packaging design. A Web search did not turn up the names of the products originally in question.
Unit-dose (“compliance”) packaging usually involves blister cards within a carton, as well as certain containers or pouches for liquids or powders. Contract packagers (many of whom are members of the Healthcare Compliance Packaging Council, a trade association for whom CPSC compliance is a central issue) have designed innovative combinations of cartons and tabs or latches that make the package difficult to open; at the same time, the packaging needs to be “senior friendly” in that it can be opened when the appropriate technique to do so is understood. Unit-dose packaging is popular for the physician’s samples distributed when many new products are launched, as well as products (such as birth-control pills) whose use involves a weekly or monthly regimen.