Codes on API packs have been required since January 2023, and on the listed Schedule H2 brands since August 2023. Vaccines, narcotics, anti-cancer products and antimicrobials follow. We are the manufacturer's side of that project — we scope what is covered, write the specification you put to vendors, and qualify what gets installed.
We do not sell printers or software, and we hold no vendor agreements. That is the point of asking us.
Four separate obligations, created by three instruments, on four different dates. They are not one deadline and they do not all reach the same products.
A machine-readable code at every packaging level of every API manufactured in or imported into India, carrying the product identification code, API and brand name, manufacturer, batch number and size, manufacturing and expiry or retest date, the shipping container code and the licence number.
A bar code or QR code on the primary label — or the secondary label where there is not enough space — storing the product identification code, generic and brand names, manufacturer name and address, batch number, manufacturing and expiry dates and the manufacturing licence number.
Schedule H2 extended from a named-brand list to whole therapeutic categories, so coverage no longer depends on whether a specific brand was scheduled.
The same category-wide extension, on a later date — the single largest tranche by SKU count for most general-range manufacturers.
Dates for the category extension are taken from published reporting of the June 2026 amendment. We check them against the Gazette as part of a scope assessment rather than asking you to act on a secondary source — and we will tell you if what we find differs from this page.
Each of these turns up in vendor material. Each is wrong in a way that costs money or credibility.
“India has a serialization and track-and-trace mandate.”
For the domestic market it does not. Rule 96 is a labelling and authentication requirement — a code on a pack that resolves to product data. There is no national movement-reporting hub for domestic supply, no Indian equivalent of EU FMD, US DSCSA or UAE Tatmeen. Exports are a separate regime with their own track-and-trace requirements.
“The deadline is 2027, so there is time.”
Two obligations are already in force. APIs have required a code at every packaging level since January 2023, and the listed Schedule H2 brands since August 2023. If either applies to you and the code is not on the pack, the exposure is present-tense, not a planning item.
“GS1 Sunrise 2027 is a regulatory deadline.”
It is a GS1 industry readiness target for retail point-of-sale systems to read 2D codes, enforced by retailers through supplier agreements rather than by any regulator. It matters commercially, and it is not CDSCO. Treating the two as one timeline is the fastest way to lose a regulator's confidence.
“The vendor's system will make us compliant.”
Compliance attaches to the holder of the manufacturing licence, not to the supplier of the equipment. A printer that marks the right data on the wrong pack level, or a code that is not reproducibly readable at end of line, is the licensee's finding to close at inspection.
Most sites start with the first and stop to think. Each is scoped and priced on its own.
Which of your SKUs are caught, by which obligation, and on what date — resolved product by product rather than category by category.
Practice area: Regulatory Compliance
What this covers
Deciding what the code must carry, where it goes, and getting the artwork through change control without breaking the rest of the label.
Practice area: Regulatory Compliance
What this covers
A written user requirement specification you can put to vendors — so quotes come back comparable, and so what arrives is what you asked for.
Practice area: Business Strategy
What this covers
Qualifying the supplier and the installed system the way an inspector will expect to see it qualified.
Practice area: Quality Assurance
What this covers
The SOPs, records and training that turn a working machine into a defensible compliance position.
Practice area: Quality Assurance
What this covers
What we do not do. We do not supply, install or commission printers, vision systems or serialization software, and we do not resell anyone's platform. We write what you need, help you judge what you are being offered, and qualify what you install. The equipment contract is between you and your vendor.
Savison Life holds no vendor agreements and takes no commission on hardware or software. The specification you get is written for your line, not for a product someone needs to move. When we say a quote is over-specified, there is nothing in it for us.
Responsibility for what is on the pack sits with the holder of the manufacturing licence. Writing the requirement yourself — rather than accepting a vendor's standard scope — is what makes that responsibility defensible at inspection.
A scope assessment is a different size of job from a full qualification programme. Engagements are scoped and priced per problem; there is no retainer to buy into before anyone looks at your situation.
Most line disruption traces back to a requirement nobody wrote down — a substrate the printer cannot hold a code on, or a reject path that was never designed. The cheapest place to find that is on paper, before purchase.
Tell us what you make and how many lines are involved. We will come back with which obligations reach your products, on what dates, and what a first piece of work would look like.
If this is not something we can help with, we will say so rather than take a meeting.
Prefer to describe it in your own words? Use the general contact form.
Instruments referenced on this page
The regulator is the Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India, under the Drugs and Cosmetics Act 1940. This page is general information about published requirements and is not regulatory or legal advice. Verify every instrument against the Gazette of India before acting on it.
