QR Code-Based Track-and-Trace Mechanism For Medicines

Syllabus: GS2/ Health/ Governance

Context

• The Ministry of Health and Family Welfare has notified amendments to the Drugs Rules, 1945 to expand the ambit of Schedule H2 and bring additional categories of drugs under the QR Code-based track and trace framework.

About

• Under the amended provisions, all vaccines, antimicrobials, narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, and all anti-cancer drugs have been included under Schedule H2 of the Drugs Rules, 1945.
  • The requirement for QR Code-based identification was earlier applicable to the top 300 pharmaceutical brands in the country. 
• Schedule H2 provides for the affixation of a Bar Code or Quick Response (QR) Code on the packaging of specified drug products to facilitate their authentication and traceability across the supply chain.
• Manufacturers of these drug formulations will be required to print or affix a Bar Code or Quick Response (QR) Code on the primary packaging label of the product or, where there is inadequate space, on the secondary packaging label. 

Information in the QR Code

• The QR Code shall store information that can be accessed through software applications to facilitate authentication and verification of the product throughout the supply chain.
• The QR Code shall carry nine key data elements for each drug product, namely;
  • The unique product identification code, proper and generic name of the drug, Brand name, name and address of the manufacturer, batch number, date of manufacture, date of expiry, manufacturing licence number, and details of excipients. 

Need for the QR Code System

• Combat Counterfeit Medicines: Counterfeit medicines containing incorrect, diluted or no active pharmaceutical ingredients pose serious public health risks.
  • In  2025, a massive health crisis erupted in Madhya Pradesh’s Chhindwara district, resulting in the deaths of more than 20 children under the age of five.
• To Prevent Tampering and Diversion: The system helps detect medicines that have been tampered with, diverted into illegal supply chains or repackaged using genuine containers.
• Improve Drug Recall Mechanisms: Digital traceability enables regulators and manufacturers to quickly identify the location of affected batches and carry out targeted recalls.

Significance of the Mechanism

• The traceability mechanism will facilitate authentication of medicines at various stages of the supply chain and enable improved tracking and verification of drug products. 
• It will also contribute to the national fight against Anti-Microbial Resistance (AMR) by enabling better identification and monitoring of counterfeit and substandard antimicrobial products.
• The system will strengthen India’s drug regulatory framework and support progress towards the World Health Organization Global Benchmarking Tool (GBT) Maturity Level 4, the highest level of regulatory maturity.

Challenges in Implementation

• Increased cost: Implementing the system would require the companies to put in place mechanisms for generating these unique codes for every packet and a tracking platform allowing these to be logged at every stage.
• Possibility of Incorrect Registration: If there is a delay in logging the genuine product and the counterfeit gets logged into the system, then the genuine drug might come across as counterfeit.
• Digital Infrastructure: The system requires seamless digital integration and real-time data sharing among manufacturers, distributors, wholesalers, retailers, and regulators to ensure effective traceability.

Concluding remarks

• The QR code-based system is a major reform that will strengthen pharmaceutical supply-chain integrity, and improve patient safety through end-to-end digital traceability.
• In the long run, the initiative will reinforce India’s position as a trusted global supplier of quality medicines while advancing the objectives of Digital Health and Good Governance.

Source: PIB, IE