The Central Government vide notification dated 14th June, 2022 has issued the draft Drugs (Amendment) Rules, 2022
Objections and suggestions, if any, may be emailed at drugsdiv-mohfw@gov.in. within 30 days of publication of this notification. The rules shall come into force on the First day of May, 2023.
The amendment has listed a set of drugs in Schedule H2 and manufacturers of drug formulation products as specified in the Schedule H2 of the said rule, 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 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 Manufacturing license number.
