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Regulatory catalogue · RI-IN-003 · India

Schedule H2: QR / barcode on top 300 brands

G.S.R. 823(E): Drugs Rules amendment inserting Schedule H2 (barcode or QR code on the top 300 drug formulation brands)

L2Implementing legislationIn forceArtwork impact: high

Summary

Manufacturers of the listed brands print or affix a barcode or QR code on the primary package label (or the secondary package where space is inadequate) with product identification, name, brand, manufacturer, batch, dates and licence number.

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Relevance by packaging component

ComponentRelevanceWhat it concerns
CartonOuter packaging / folding carton D Direct
LabelImmediate container label (bottle, tube, large vial, bag) D Direct
Blister / foilBlisters, strips, sachets, lidding foil D Direct
Small unitSmall immediate packaging: ampoule, small vial, cartridge, pen –
LeafletPackage leaflet / PIL, package insert, prescribing information, Medication Guide –
DeviceIntegral or co-packaged device and its instructions for use –
Shipper / caseTertiary packaging: shipping case, homogeneous case, pallet –
e-LabellingElectronic product information, QR / 2D-code linked content –

packart.dev summary, not a quotation of the source. Confirm requirements in the official text before regulatory use.