Last Updated on January 13, 2024 by The Health Master
Bar code or QR code for 300 brands
Download Notification No. GSR 823(E) dt 17-11-2022, the link is given below: The Ministry of Health and Family Welfare (Department of Health and Family Welfare, New Delhi) has notified 300 Brand names of drug formulations in the Drugs Rules, 1945, vide notification No. GSR 823(E) dt 17-11-2022.
These rules may be called the Drugs (Eighth Amendment) Rules, 2022.
Schedule H2 introduced
The government has now inserted Schedule H2, a new schedule, after Schedule H1, which contains 300 brands of formulations.
Manufacturers of these brands shall have to print QR Codes / Bar Codes on the primary packaging of the formulation, with effect from August 1, 2023.
The manufacturers of drug formulation products as specified in Schedule H2 shall print or affix a Bar Code or Quick Response Code on their primary packaging label or, in case of inadequate space in the primary package label, on the secondary package label that stores data or information legible with a software application to facilitate authentication.
The stored data or information referred to in sub-rule (6) shall include the following particulars,
namely:
- (i) unique product identification code;
- (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 license number.”.
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