QR Code Mandate for High-Risk Drugs
India has made QR codes mandatory on vaccines, anti-microbials, and cancer drugs from February 1, 2025. The order, issued by the Drugs Controller General of India (DCGI), aims to curb the sale of counterfeit medicines and improve supply chain transparency. The new rule applies to all manufacturers and importers of these categories, requiring them to affix QR codes on primary and secondary packaging.
Implementation Details
The QR code must contain a unique product identifier, batch number, manufacturing date, expiry date, and a unique serial number. The DCGI has directed all state drug controllers to enforce compliance. Companies have been given a transition period until February 1, 2025, to comply. The move is expected to help patients and healthcare providers verify the authenticity of medicines by scanning the code with a smartphone.
Impact on Counterfeit Drugs
According to the World Health Organization, counterfeit drugs account for up to 10% of medicines in low- and middle-income countries. The DCGI noted that the mandate would help track and trace drugs from manufacturer to patient, reducing the risk of fake products entering the supply chain. The measure is part of the government's larger push to digitize healthcare under the Ayushman Bharat Digital Mission.
Industry Response
Pharmaceutical industry bodies have welcomed the move but raised concerns about implementation costs and technical challenges. "While the intent is commendable, small manufacturers may face difficulties in setting up the necessary infrastructure," said a spokesperson for the Indian Pharmaceutical Alliance. The DCGI has assured that it will provide guidance and support to ensure a smooth transition.
