The Drug Regulatory Authority of Pakistan has announced October 9 as the final deadline for implementing a mandatory 2D barcode and serialization system on all medicine packaging across Pakistan.
The move is part of a nationwide effort to strengthen drug safety, improve transparency in the pharmaceutical supply chain, and curb the circulation of counterfeit and substandard medicines.
Barcode and serialization required on all medicines
Under the new regulations, all pharmaceutical manufacturers and importers will be required to print a unique 2D barcode along with serialization data on every pack of human and veterinary medicines sold in Pakistan.
The barcode will serve as a digital identity for each medicine pack, allowing it to be tracked from production or import through distribution and retail sale.
DRAP will oversee the rollout of the Pharma Track and Trace System, which is designed to provide real-time visibility across the pharmaceutical supply chain.
Federal cabinet approval already secured
The initiative has already received approval from the federal cabinet through amendments to the Drugs Labelling and Packing Rules, 1978.
Following cabinet approval, DRAP issued formal implementation directives to pharmaceutical companies and informed key industry stakeholders, including the Pakistan Pharmaceutical Manufacturers Association, Pakistan Veterinary Pharmaceutical Association, Pharma Bureau, drug inspectors, and provincial drug control authorities.
Officials said companies have been given sufficient time to upgrade their systems and must ensure full compliance before the October 9 deadline.
Consumers to verify medicines using smartphones
Once the system becomes operational, consumers will be able to verify the authenticity of medicines by scanning the 2D barcode using a smartphone.
The scan will provide essential product details, including the medicine’s expiry date, usage instructions, batch number, and official retail price.
Regulators believe this feature will empower consumers to identify genuine products and reduce the risk of unknowingly purchasing counterfeit or expired medicines.
Strengthening oversight and accountability
According to DRAP officials, the track and trace system will also significantly improve regulatory oversight.
By enabling real-time tracking, authorities will be better equipped to identify supply chain irregularities, investigate complaints, and recall defective or unsafe products more efficiently.
The system is expected to improve coordination between federal and provincial drug control authorities and enhance enforcement against illegal manufacturers and distributors.
Industry compliance under scrutiny
Pharmaceutical companies have been instructed to complete all technical, printing, and data integration requirements before the deadline.
DRAP has warned that failure to comply with the new labelling and serialization rules after October 9 could lead to regulatory action, including penalties, suspension of licenses, or removal of non-compliant products from the market.
Officials said inspections and audits will be carried out to ensure enforcement once the deadline passes.
Part of broader healthcare reform
The introduction of mandatory serialization is seen as a major step toward modernizing Pakistan’s pharmaceutical regulatory framework.
Health experts say the initiative aligns Pakistan with international best practices and could help restore public confidence in medicine safety, particularly in a market that has long struggled with counterfeit drugs.
DRAP officials emphasized that the success of the system will depend on strict enforcement, industry cooperation, and public awareness.
Focus on patient safety
Authorities stressed that the primary goal of the policy is patient protection.
By making every medicine traceable and verifiable, the government aims to reduce health risks, improve treatment outcomes, and ensure that patients receive safe and effective medicines.
As the October 9 deadline approaches, regulators are urging pharmaceutical companies to complete preparations and consumers to familiarize themselves with the new verification system.
