ISLAMABAD: Pharmaceutical companies that fail to provide the required product information for Pakistan’s new medicine-tracking system could face legal action, including the sealing of manufacturing facilities, Federal Minister for National Health Services, Regulations and Coordination Syed Mustafa Kamal has warned.
The warning came during a review meeting in Islamabad on the implementation of two-dimensional (2D) barcodes and serialisation on medicine packaging. Officials told the meeting that around 80 per cent of pharmaceutical companies had initiated the implementation process, while formal notices would be issued to those that had not submitted the required product data.
Kamal said the government would not compromise on enforcing the system, which is intended to improve the traceability of medicines and help prevent counterfeit and falsified products from entering the legitimate supply chain. Companies that fail to meet the prescribed requirements within the stipulated period would face legal action, he said, warning that their production facilities could also be sealed.
The latest warning marks a shift towards enforcement following the introduction of a nationwide Pharmaceutical Track and Trace System by the Drug Regulatory Authority of Pakistan (DRAP). The system is designed to create a digital record of medicines as they move through the pharmaceutical supply chain, giving regulators stronger tools to monitor products and helping consumers verify the medicines they purchase.
October 9 marks start of mandatory compliance
Under DRAP’s notification, compliance with 2D barcoding and serialisation became mandatory from October 9, 2026, for registered pharmaceutical products manufactured locally or imported into Pakistan on or after that date.
The requirement forms the first phase of the national track-and-trace initiative and applies to both domestic manufacturers and importers. DRAP has clarified that medicine batches manufactured locally or imported before October 9 are exempt from the new requirement and may continue to be imported, distributed and sold.
The regulatory framework requires a GS1 DataMatrix 2D barcode carrying product identification and batch-level information, alongside a unique serial number. This allows individual saleable packs to be distinguished and traced rather than relying only on information identifying a product or batch.
DRAP has also issued technical guidelines on GS1 DataMatrix barcoding and serialisation to help companies meet the requirements. The authority has said the system is being rolled out in phases and is intended to strengthen supply-chain transparency, support product recalls and help identify spurious, falsified, counterfeit and unregistered medicines.
What the barcode system means for patients
The system is intended to make medicine verification more accessible to consumers, not just regulatory authorities. Under the government's announced plan, a mobile application will allow people to scan a medicine's barcode and check key information, including its authenticity, manufacturer, batch number, expiry date and official price.
This could help patients and pharmacists identify products that do not match the information held in the regulatory system, including potentially counterfeit or expired medicines. It is also expected to improve the ability of regulators and companies to trace products through the supply chain and respond more efficiently when a quality or safety concern requires a recall.
The system is particularly relevant to efforts to distinguish genuine medicines from falsified products that may enter distribution channels. However, a barcode is a verification and traceability measure; it does not replace the need for quality testing, manufacturing oversight, inspections and effective action against illegal supply.
A regulatory initiative years in the making
Pakistan's move towards medicine barcoding is not new. The proposal dates back several years, with earlier regulatory efforts aimed at introducing 2D codes on pharmaceutical packaging. Dawn reported in July 2026 that the initial proposal had been floated in 2015 and approved by the federal cabinet in 2017, but implementation had been delayed by bureaucratic hurdles.
The federal cabinet approved the nationwide Track and Trace System in June 2026, alongside amendments to the Drugs (Labelling and Packing) Rules, 1986. The approval provided the regulatory basis for requiring pharmaceutical manufacturers and importers to use standardised 2D barcodes and serialisation data on medicine packaging.
The Drug Regulatory Authority of Pakistan is responsible for overseeing the rollout. In October, DRAP reiterated that the requirement would apply to registered medicines manufactured locally or imported from October 9, while exempting earlier batches from the new compliance condition.
The system is part of a broader effort to modernise pharmaceutical regulation and improve the monitoring of medicines from production to distribution. Its effectiveness will depend not only on the introduction of codes but also on the accuracy of product data, the reliability of the digital infrastructure and the ability of regulators to act on discrepancies.
Industry readiness and implementation challenges
The pace of compliance has been a concern for the pharmaceutical industry since the initiative was first discussed. Last month, the Pakistan Pharmaceutical Manufacturers Association (North) Chairman Usman Shaukat had supported the barcode system in principle but called for a realistic implementation timeline.
Shaukat said the entire industry was not equipped with the printing technology required to place 2D barcodes on all products and argued that the deadline should be determined in consultation with manufacturers. He also cautioned that genuine medicines could disappear from the market if companies were unable to obtain the necessary equipment in time.
DRAP has since said it has engaged industry bodies, including the Pakistan Pharmaceutical Manufacturers Association and Pharma Bureau, through policy discussions. The authority has also conducted technical sessions, workshops and training roadshows to guide manufacturers and importers on barcode standards, serial-number generation, vendor readiness and integration with its e-Services portal.
The latest estimate that around 80 per cent of companies have started implementation suggests progress, but it does not establish that the same proportion has completed compliance or that all their products have been successfully registered in the system. The minister's warning signals that the government intends to pursue companies that have not submitted the required information.
Regulatory enforcement and the road ahead
The latest meeting was attended by the Chief Executive Officer of the Drug Regulatory Authority of Pakistan, representatives of relevant institutions and stakeholders from the pharmaceutical industry.
The government is expected to issue formal notices to companies that have not submitted their product information, with non-compliant firms facing legal proceedings if they fail to meet the prescribed requirements. The possibility of sealing manufacturing facilities raises the stakes for companies that have yet to complete the required data submission and implementation process.
For patients, the value of the initiative will ultimately be measured by whether it makes medicines easier to authenticate, strengthens action against falsified products and improves confidence in the pharmaceutical supply chain. For manufacturers and importers, the immediate challenge is to ensure that product information, packaging systems and serialisation processes meet DRAP's requirements.
The nationwide rollout therefore represents more than a packaging change. It is a regulatory shift towards digitally traceable medicines, with its success dependent on consistent implementation, industry readiness and effective oversight.
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