WHO Considers Unit-Level Serial Numbers for Drug Tracking

The World Health Organization (WHO) is seeking comments on a draft policy on tracking and tracing drugs through the supply chain that would push globally for unit-level serial numbers.

The draft policy acknowledges that requiring unique serial numbers on every drug product sold would involve significantly higher manufacturing costs for drugmakers, as well as slower line speeds and more product rejections.

In addition, verification alone will have less value “if it is not paired with a tamper proof seal ensuring that the verification of the identifier on the pack refers to the content of the pack,” WHO said.

Batch-level identification will work for product recalls and pharmacovigilance systems, but unit-level serialization “is likely more fit” for investigations of substandard and illicit drug products, cargo theft and diversion, the WHO said.