QR codes/barcodes to be on primary packaging label or, in case of inadequate space, on the secondary package label that stores data or information legible with software application to facilitate authentication
Finalising the draft notification issued earlier in June 2022, the Department of Health and Family Welfare has mandated that from August 1,2023, the top 300 brands will need to have QR codes/ barcodes.
The notification dated November 17 specifies that manufacturers of drug formulation products as specified in Schedule H2, under the new Drugs Rules or the Drugs (Eighth Amendment) Rules, 2022, 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 software application to facilitate authentication.
The stored data or information will have to include eight data points namely:
(i) unique product identification code;
(ii) proper and generic name of the drug;
(ii) proper and generic name of the drug;
(iii) brand name;
(iv) name and address of the manufacturer;
(v) batch number;
(vi) date of manufacturing;
(vii) date of expiry; and
(viii) manufacturing licence number
(iv) name and address of the manufacturer;
(v) batch number;
(vi) date of manufacturing;
(vii) date of expiry; and
(viii) manufacturing licence number
The list of 300 top drugs includes Becosules, Calpol, Allegra, Dolo, Augmentin, Saridon, and Thyronorm among others.