The Union Health Ministry has now inserted Schedule H2 to require barcodes on the top 300 drug brands’ medicines.
The addition of Schedule H2, following Schedule H1, aims to ensure authenticity and traceability throughout the manufacturing and supply chain, and will take effect on August 1, 2023.
Manufacturers of Schedule H2 drug formulation products must print or affix a Bar Code or a quick response code to their packaging.
The All India Organisation of Chemists and Druggists has made the decision to reduce the sale of counterfeit medicines. AIOCD General Secretary Rajiv Singhal said, “We welcome the government of India’s step; these QR codes in medicines will control medicine duplication”.
The notification issued by the Ministry of Health and Family Welfare reads, “The manufacturers of drug formulation products as specified in Schedule H2 shall print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with a software application to facilitate authentication”.
It said, “Once approved, the amendments to Drugs and Cosmetic Rules, 1945 will come into force from May next year”.
India Formulations, Glenmark Pharmaceuticals Ltd Executive Vice President and Business Head Alok Malik said, “We welcome the government’s move to introduce QR codes in medicine packaging as they can greatly help in controlling the counterfeiting of drugs by tracking their journey from factory to patient. Counterfeit drugs are a threat to patient safety and this initiative will be another important move towards assuring the authenticity and traceability of the drugs”.