ISLAMABAD – Pakistani authorities have taken a major step toward tightening control over the country’s pharmaceutical market, with Drug Regulatory Authority of Pakistan (DRAP) making unique 2D Data Matrix barcodes and serial numbers mandatory for registered medicines manufactured locally or imported from October 9, 2026.
The move marks first phase of the country’s Pharmaceutical Track and Trace System, a regulatory initiative aimed at curbing counterfeit, falsified, spurious and unregistered medicines while strengthening oversight of the supply chain.
Under new requirements, pharmaceutical products falling within the scope of the regulations must carry unique identification codes containing key information about the product, its batch, expiry date and individual serial number. The system is expected to make medicines easier to trace and help authorities respond more effectively when safety concerns or suspected counterfeiting emerge.
The requirement applies to local manufacturers, multinational pharmaceutical companies and importers, covering registered medicines for human and veterinary use, including products intended for poultry.
The implementation came under review at a meeting chaired by Federal Health Minister Syed Mustafa Kamal on or around October 15, 2026, attended by the chief executives of DRAP and the National Information Technology Board (NITB). During the meeting, the DRAP chief briefed participants on the barcode and serialization arrangements. Kamal said the Ministry of Health had been working on the initiative for approximately 18 months, reaffirming the government’s commitment to eliminating counterfeit medicines from the market.
The minister also underscored the requirements for local and multinational manufacturers and highlighted restrictions on the sale of imported medicines that do not carry the prescribed codes. He further confirmed that the system extends beyond human medicines to veterinary and poultry products.
The expanded scope reflects the authorities’ approach to pharmaceutical safety as an issue that reaches beyond conventional healthcare, given the potential public-health implications of medicines used in animals.
By linking these details to individual packs, the system is intended to improve the traceability of medicines as they move through the pharmaceutical supply chain.
The information could assist regulators in investigating suspicious products, locating affected batches and coordinating recalls when medicines are found to be defective or unsafe. Companies that fail to comply with the applicable requirements may face legal action. However, serialization is not an absolute guarantee of authenticity. Counterfeiters could potentially copy legitimate codes, making effective verification, regulatory inspections and enforcement essential to the system’s success.
Despite the new mandate, consumers and retailers should not assume that every medicine without a 2D barcode is counterfeit. Products manufactured or imported before October 9, 2026, are exempt from the new coding requirement and may continue to be distributed and sold legally, subject to other applicable regulations.
This means pharmacies and medical stores may continue to stock older packaging while newly coded products gradually enter the market. The transition is expected to take place as existing inventories are sold and replaced. For consumers, the date of manufacture or import and the regulatory status of the product are therefore important considerations when assessing packaging that lacks the new identification code.
The initiative is also expected to introduce a digital verification facility through which consumers, pharmacists and medical store operators can check medicine details using a mobile application. According to ministerial statements and media reports, the proposed service is intended to help users verify product authenticity and access information such as price and expiry date.
However, details of the public-facing application have appeared more prominently in ministerial announcements and secondary reporting than in DRAP’s formal circulars, which primarily focus on manufacturers’ and importers’ obligations. The availability, precise functions and operating arrangements of the consumer application should therefore be confirmed through official announcements.
