This article is about MDR India for a notice published in the Indian Gazette on June 14, 2022, by the Indian Government’s Ministry of Health and Family Welfare. The CDSCO is requesting feedback and suggestions from individuals who are likely to be impacted before a 30-day window after the date of publication expires.
- These rules may be called the Drugs Rules, 2022 in the Eighth Amendment.
- These will become effective on August 1st, 2023.
In rule 96, after sub-rule (5) and before the explanation, the following sub-rules will be inserted –
- (6)The manufacturers of drug formulation products as specified in Schedule H2 (The link is found below) need to print or affix Barcode 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.
- (7) The stored data or information referred to in sub-rule (6) need to include the following particulars, namely:—
- The Unique product identification code
- A Proper and generic name of the drug
- Brand name
- Name and address of the manufacturer
- Batch number
- Date of manufacturing
- Date of expiry
- Manufacturing license number
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Source – Central Drugs Standard Control Organization, India
