On 17-11-2022, the Ministry of Health and Family Welfare has published the Drugs (Eighth Amendment) Rules, 2022 to further amend the Drugs Rules, 1945.
The amendment inserts a clause in Rule 96 providing the manufacturers of drug formulation products must 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, namely:—
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unique product identification code;
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proper and generic name of the drug
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brand name
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name and address of the manufacturer;
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batch number;
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date of manufacturing;
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date of expiry; and
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manufacturing licence number.
