DRAP mandates barcodes, serial numbers on medicine packaging

PAKISTAN – The Drug Regulatory Authority of Pakistan has made barcode printing and unique serial numbers mandatory for pharmaceutical products, requiring compliance on all medicines manufactured from October 19, 2026.

Under the new system, unique serial numbers will be required on all pharmaceutical and biological medicines manufactured from the specified date, according to the notification.

Barcodes and serial numbers must be printed on medicine packaging, and products without barcodes will not be permitted for sale in the market after the deadline. 

The framework applies to allopathic medicines, including biological products for human and veterinary use, and does not cover categories such as alternative medicines, nutraceuticals, medical devices, medical gases and radiopharmaceuticals.

Digital Platform to Track Medicines from Manufacturing to Patient

The new system will allow authorities to monitor medicines through a digital platform and maintain a record from manufacturing through to patient use. 

This end-to-end traceability addresses persistent challenges in pharmaceutical supply chains, where counterfeit and substandard products can enter distribution networks undetected. 

Unit-level serialisation makes duplication considerably harder than batch-level coding, since each pack carries a distinct identifier that can be verified at multiple points along the supply chain.

Training Workshops Scheduled Across Three Regions

DRAP has directed the pharmaceutical industry to complete preparations for implementation of the new system. 

Training workshops will be held for pharmaceutical manufacturers in Islamabad, Rawalpindi and Azad Jammu and Kashmir, conducted on the directions of the DRAP chairman. 

These sessions are intended to prepare packaging and production teams for the operational changes required, including variable data printing, inline verification and integration with regulatory reporting systems.

Packaging Lines Face Compliance and Investment Requirements

For pharmaceutical packaging operations, the mandate introduces new demands around serialisation-ready printing, vision inspection and data management. 

Manufacturers must ensure that barcode and serial number application maintains readability through distribution, storage and dispensing, since damaged or obscured codes undermine traceability. 

The requirement also affects label and carton suppliers, who must deliver substrates compatible with variable data printing at production speeds. 

Pakistan’s pharmaceutical sector exports to multiple international markets, and domestic serialisation capability may support compliance with similar requirements in destination countries. 

Products lacking compliant packaging cannot be sold after the deadline, making implementation timelines commercially significant for manufacturers across the country.

Subscribe to our email newsletters that provide busy executives like you with the latest news insights and trends from Africa and the World. SUBSCRIBE HERE