CDSCO's New Labelling Rules.

Schedule H2 serialization got pharma packaging teams used to one big compliance wave. A second one is already drafted.

Schedule H2 serialization got pharma packaging teams used to one big compliance wave. A second one is already drafted, and it's aimed squarely at what's printed on the box itself — not just the QR code inside it.

The draft: Notification F.1-54/2024-DA

In March 2025, CDSCO issued draft guidelines under Notification No. F.1-54/2024-DA, proposing an overhaul of India's pharmaceutical labelling standards. The public consultation period closed in June 2025. As of now, final enforcement timelines haven't been published as a Gazette Notification — but implementation is expected with a transition phase extending into 2026, and the Drugs Consultative Committee has already formed an expert subcommittee, including packaging specialists, to finalize the standards.

The subcommittee's stated remit is specific: fix unreadable expiry dates, oversized font problems, and reflective blister foils that compromise patient safety. This isn't abstract regulatory language — it's targeting exact, named packaging failures that pharmacists and patients have been reporting for years.

What the draft covers

• Braille inscriptions — required on mono-cartons, showing product name and strength. Beyond accessibility, Braille embossing is a natural anti-counterfeit layer since it's harder to replicate cheaply than flat print
• Voice-assisted QR codes — delivering audible dosage and usage information, going beyond Schedule H2's existing product-identification QR requirement
• High-contrast printing — mandatory for expiry dates, batch numbers, and MRP, directly targeting the reflective-foil readability problem the subcommittee flagged
• Minimum font size standards — a baseline size requirement across all packaging, closing the loophole where technically-legible-but-tiny text passed compliance checks

How this compares to Schedule H2

Schedule H2 already requires QR codes on India's top 300 selling drug brands, encoding serial number and key product details. Manufacturers spent the last few years retrofitting printers, integrating vision systems, and validating ERP-to-packaging-line data flows to hit that mandate.

This new draft builds on top of that infrastructure rather than replacing it — voice-assisted QR codes are an enhancement to the existing QR requirement, not a separate system. If your Schedule H2 implementation is solid, you're extending it, not starting over. If it's fragile, this is a second, harder deadline landing on the same weak foundation, and the gaps that were tolerable under Schedule H2's simpler requirements will become much less tolerable once voice-data accuracy is a patient-facing feature.

Where India sits versus EU and US standards

India's requirements are converging with EU expectations on readability and serialization, while still trailing US DSCSA on supply chain aggregation depth. EU rules separately mandate tamper-evident features and Braille in destination-market languages; FDA rules under 21 CFR 201 focus primarily on label clarity, with serialization and tamper-evidence often adopted voluntarily by exporters aligning to global expectations.

What triggers revalidation

That means the Braille, voice-QR, and high-contrast changes aren't a single artwork update — they're a full packaging-line revalidation event once finalized. Early engagement with a packaging expert to review artwork revisions and tooling validation is worth the lead time, given the DCC subcommittee's active involvement suggests this will not stay a draft indefinitely. Packaging line downtime for revalidation is expensive; scheduling it proactively around your own production calendar beats reacting to a compliance deadline announced with a short runway.

The authentication angle

Voice-assisted QR codes and enhanced serialization both depend on one thing: a data layer that's actually reliable at the unit level. A QR code that plays the wrong dosage audio because of a data-sync error is worse than no voice feature at all — it's a patient safety incident waiting to happen.

Ratifye's cryptographic authentication layer sits on top of your existing GS1 barcode infrastructure, giving you a verified, tamper-evident data record per unit that any downstream feature — voice QR, Braille verification, high-contrast validation — can build on with confidence in the underlying data.