The Central Drugs Standard Control Organisation (CDSCO) has issued AQS on Implementation of the the Drugs (Eighth Amendment) Rules, 2022. The FAQs particularly deal with the bar code or QR code on the notified 300 brands. These FAQs were published on 25th July, 2023.
It may be recalled that by virtue of the the Drugs (Eighth Amendment) Rules, 2022, manufacturers of drug formulation products as specified in Schedule H2 are required to 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 referred above shall include the following particulars:
- unique product identification code;
- proper and generic name of the drug
- brand name
- name and address of the manufacturer;
- batch number;
- date of manufacturing;
- date of expiry; and
- manufacturing licence number.
The CDSCO has now issued 8 FAQs on the aspects covering this amendment. The requirement of complying with the amendment is effective from 1st August, 2023.