Pakistan approves nationwide drug track-and-trace system to combat counterfeit medicines

ISLAMABAD: In a landmark move aimed at strengthening medicine safety and eliminating counterfeit drugs from the market, the federal cabinet has approved the nationwide implementation of a Track and Trace System for pharmaceutical products across Pakistan.

The decision, announced by Federal Minister for Health Mustafa Kamal, is being described as one of the most significant regulatory reforms in Pakistan's pharmaceutical sector in recent years. Alongside the approval of the digital tracking framework, the cabinet has also cleared amendments to the Drug Labeling and Packing Rules, 1978, creating the legal foundation required for nationwide implementation.

Health officials say the initiative will introduce a modern digital mechanism capable of tracking and verifying medicines throughout the pharmaceutical supply chain, from manufacturing facilities to pharmacies and ultimately to consumers.

Every medicine to become digitally traceable

According to the Ministry of National Health Services, the new system will, for the first time, make every medicine sold in Pakistan digitally traceable and verifiable.

Under the revised regulatory framework, all pharmaceutical manufacturers and importers will be required to place standardized two-dimensional (2D) barcodes and serialization data on medicine packaging. These digital identifiers will enable regulators to monitor pharmaceutical products at every stage of distribution, helping identify counterfeit, fake, substandard, diverted, or illegally distributed medicines.

Health Minister Mustafa Kamal termed the cabinet's decision a "historic step" toward protecting public health and restoring confidence in the country's medicine supply chain.

"This decision marks a major and historic step towards eliminating counterfeit, fake and substandard medicines from Pakistan," he said.

Consumers to verify medicines digitally

A key feature of the system is its direct benefit to patients and consumers.

Once fully implemented, members of the public will be able to access authentic information about medicines, including expiry dates, pricing details, and verification status through digital verification mechanisms.

Officials say this added transparency will help consumers make informed healthcare decisions while reducing the risk of purchasing counterfeit or unsafe medicines.

Public health experts have long warned that counterfeit and substandard medicines pose a serious threat to patient safety, treatment outcomes, and healthcare systems, particularly in low- and middle-income countries where medicine supply chains can be vulnerable to illegal distribution networks.

DRAP to oversee nationwide rollout

The Drug Regulatory Authority of Pakistan (DRAP) has been tasked with overseeing the nationwide implementation of the Track and Trace System.

According to the ministry, DRAP will issue detailed technical guidelines for pharmaceutical manufacturers, importers, distributors, and other stakeholders to facilitate compliance with the new requirements.

Officials stated that consultative meetings with industry representatives and relevant stakeholders have already been conducted to ensure a smooth transition and practical implementation of the system across the pharmaceutical sector.

Strengthening pharmaceutical regulation and oversight

The government believes the adoption of advanced digital technologies will significantly strengthen the security, quality, and transparency of Pakistan's pharmaceutical supply chain.

The Track and Trace System is expected to replace traditional monitoring methods with a modern regulatory framework that allows real-time product authentication and enhanced oversight of medicine movement throughout the country.

Mustafa Kamal said the initiative would not only improve public health protection but also position Pakistan among the leading countries in the region in pharmaceutical regulation, drug monitoring, and supply chain oversight.

Healthcare experts note that medicine serialization and digital traceability systems have become increasingly important worldwide as governments seek to curb counterfeit medicines, improve patient safety, and strengthen regulatory enforcement.

With the federal cabinet's approval now secured, the focus will shift toward implementation timelines, industry compliance, and the operational rollout of one of Pakistan's most ambitious pharmaceutical regulatory reforms.

"The Track and Trace System will establish a strong and effective barrier against counterfeit medicines and ensure the protection of public health, lives and trust," the health minister said.

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