India's Central Drugs Standard Control Organisation (CDSCO) has implemented barcode requirements for pharmaceutical products under Schedule H and H1 of the Drugs and Cosmetics Act. The system requires 2D barcodes on primary and secondary packaging for drugs exported from India and for certain domestic drugs.
Barcode Requirements
Schedule H and H1 drugs manufactured for export must carry a 2D barcode (DataMatrix) on the primary and secondary packaging containing: a unique product identifier; batch/lot number; manufacturing date; expiry date; and manufacturer details. The barcode must comply with GS1 standards.
Export Requirements
Indian pharmaceutical exporters must comply with the track-and-trace requirements of the destination country (DSCSA for US, FMD for EU, NMPA system for China) in addition to Indian domestic requirements. India is a major global pharmaceutical manufacturer and exporter, making multi-country compliance a significant operational challenge.
Domestic Requirements
For domestic distribution, Schedule H1 drugs (including certain antibiotics and psychotropic substances) must be dispensed only against a valid prescription and must carry barcodes enabling traceability. The CDSCO is progressively expanding barcode requirements to additional drug categories.