Pharmaceutical Serialization in India — Label and Ribbon Requirements

Since 1 August 2023, India's GSR 823(E) has required a bar code or QR code on the 300 brands listed in Schedule H2, carrying product, batch, date and licence details. The ribbon must keep small codes scannable. Codewell suggests testing CW-28 or CW-33 on polyester, CW-28 on polypropylene, and CW-22 on coated-paper cartons.

India's Central Drugs Standard Control Organisation (CDSCO) explains the rule in its FAQs on GSR 823(E), dated 17 November 2022, an amendment to the Drugs Rules, 1945. Manufacturers of the drug formulations specified in Schedule H2, 300 brands in all, must print or affix a bar code or QR code. The code must include a unique product identification code, the proper and generic name and the brand name, the manufacturer's name and address, the batch number, the dates of manufacture and expiry, and the manufacturing licence number.

The rule came into force on 1 August 2023 and applies to any batch made on or after that date. If the primary package label has too little space, the code may go on the secondary package label. CDSCO leaves the unique product identification code to the manufacturer's own procedure and does not name a ribbon. Exports are covered by separate DGFT rules, so check the current notice.

For label printers, this means printing a code that stays scannable from the factory to the pharmacy.

2D codes such as QR and DataMatrix carry more data in a smaller space than a 1D barcode, so every cell has to print cleanly. For the code to scan reliably, the cells need sharp edges and consistent ink density.

A mismatched ribbon and label can produce codes with: - Soft edges (cells blend together, creating read errors) - Inconsistent density (some cells lighter than others, confusing scanners) - Ink spread (cells larger than specified, reducing quiet zone)

Any of these defects can cause scan failures, and a code that does not scan defeats the purpose of the rule. Zebra lists an incorrect combination of media and ribbon, and an incorrect darkness level, among the causes of poor or unscannable print.

For small codes on bottle and vial labels: on polyester (PET), test CW-28 or CW-33; on polypropylene (PP), test CW-28. Resin is the grade Zebra points at synthetic labels in harsh conditions. Print the code on your own label, rub it, wipe it with the cleaner it will meet, and scan it with the scanner your supply chain uses.

For secondary packaging (carton labels, shipper labels) where codes are larger: CW-22 wax-resin on coated paper is a usual starting point.

For cold chain pharma (vaccines, biologics): CW-30 on PET, which works from −40°C to +80°C; for any other grade, ask us. Test the full cycle on your own labels: print, apply, chill or freeze, thaw and scan.

Pharma makers usually check the printing system, including the ribbon and label pair, before production use, to show it consistently produces legible, scannable codes. Records typically include the ribbon grade, batch number, print darkness and speed settings, and scan results. Ask your quality team which records they need.

Codewell Image provides its DPCC approval documentation and MSDS sheets on request, and a free sample roll to test. Contact us at +91-9818254785.

The code rule is from CDSCO; the ribbon-type descriptions follow printer-maker pages. The CW grade to label pairings are Codewell's own.

1. CDSCO, FAQs on implementation of GSR 823(E) dated 17 November 2022: Schedule H2 brands, bar code or QR code contents, 1 August 2023, secondary package label
2. Zebra, What Are Thermal Transfer Ribbons?: resin for synthetic labels in harsh conditions; ribbons must be compatible with specific printers and materials
3. Zebra ZT231 user guide: Printing or Print Quality Issues: barcodes that do not scan, darkness level, incorrect media and ribbon combination