New Delhi: In a major step to tackle the growing menace of counterfeit and substandard medicines, the Central Government has announced a mandatory barcode and QR code-based track and trace system for several categories of critical medicines. The move aims to enable patients, pharmacists and healthcare providers to verify the authenticity of medicines within seconds using a mobile phone.
The Ministry of Health and Family Welfare has expanded the scope of Schedule H-2 by amending the Drugs Rules, 1945. Under the revised rules, all vaccines, antimicrobial drugs, anti-cancer medicines and drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, will be brought under the digital tracking system.
Once the QR code is scanned, users will be able to instantly access key details about the medicine, including its unique product identification code, generic and brand names, the name and address of the manufacturer, batch number, manufacturing and expiry dates, manufacturing licence number, and details of excipients wherever applicable.
According to the government, the initiative will strengthen transparency across the pharmaceutical supply chain—from manufacturing units to the patient—and significantly reduce the circulation of fake and poor-quality medicines in the market. The digital verification system is expected to improve traceability, making it easier for regulators to detect counterfeit products and remove them from circulation.
The Health Ministry has stipulated a phased implementation schedule to allow pharmaceutical companies sufficient time to comply with the new requirements. QR codes will become mandatory on all vaccines, anti-cancer medicines and drugs covered under the NDPS Act from July 1, 2027. The requirement will be extended to all antimicrobial medicines from July 1, 2028.
As per the notification, manufacturers will be required to print the barcode or QR code on the primary packaging of the medicine. In cases where the primary package does not have sufficient space, the code may be printed on the secondary packaging. The QR code will function not only as a product identifier but also as a gateway to comprehensive digital information about the medicine.
Officials said the track and trace mechanism under Schedule H-2 has been designed to ensure the identification, movement and authenticity of medicines throughout the supply chain. By enabling real-time verification of essential product information, the government expects to establish tighter control over the distribution of medicines and curb the sale of counterfeit and substandard drugs.
The Centre has provided a transition period for the pharmaceutical industry and other stakeholders to upgrade their packaging systems and adopt the required digital infrastructure before the new rules come into force. The initiative is expected to enhance patient safety, improve regulatory oversight and strengthen public confidence in the country’s pharmaceutical supply chain.
