India’s Schedule H2 QR code rule now covers four whole categories: all vaccines, anticancer drugs and NDPS drugs from 1 July 2027, and all antimicrobials from 1 July 2028.
It applies if you make finished formulations in one of these categories for sale in India, whether in your own plant or through a contract manufacturer.
Each code carries product and batch details and goes on the primary label, or on the outer pack if the label has no room.
Most of the work is getting batch data, artwork and QA sign-off in place, not the printing. Start with a list of your covered products and one pilot batch.
Say you make an antibiotic for the Indian market. From 1 July 2028, new batches will need a QR code on the label. That sounds a long way off until you count the steps in between: an artwork change, a printer check, batch data that has to reach the code, and QA sign-off on all of it.
Here is what changed. On 22 June 2026, India's health ministry notified G.S.R. 506(E), the Drugs (Seventh Amendment) Rules, 2026. It extends India's Schedule H2 QR code requirement from a list of 300 top-selling brands to four whole categories of medicines. The original 300-brand list stays as it is. For the legal background, read our full breakdown of the amendment. This guide answers three simpler questions: does it apply to you, why start now, and what to do first.
All narcotic drugs and psychotropic substances under the NDPS Act, 1985
Yes
1 July 2027
All antimicrobials
Yes
1 July 2028
A quick self-check. If you answer yes to all three, the rule applies to you:
Do you make finished formulations, in your own plant or through a contract manufacturer?
Are they sold in India?
Do they fall into one of the four categories above?
If a product is borderline, such as a combination product, flag it to your regulatory team now rather than in mid-2027.
Why July 2027 is closer than it looks
Most teams hear "QR code" and think of a printer. The printing is usually the easy part. The real work is getting the right data into the code for every batch, and that touches several teams at once:
Artwork. Every covered product needs a label revision with room for the code, and artwork changes go through their own approvals.
Batch data. Each code carries that batch's details, so batch number, manufacturing date and expiry date have to flow from your production records to the code without manual errors.
Printing. Your line printers need to print a scannable code alongside the batch details they already print. Some lines can do this today; some cannot.
Sign-off. QA needs a way to check codes before a batch is released, and a record that they did.
For a manufacturer with dozens of covered products across a few plants, that is months of coordinated work. Teams that start now can test on a handful of batches. Teams that start in mid-2027 end up testing on live stock.
The printing is the easy part. Each code depends on artwork, batch data and QA sign-off coming together.
Five steps to get ready
List your products. Mark each one by category and deadline: 2027 or 2028.
Pull your current labels. Check whether the primary label has room for a code, or whether the outer pack will carry it.
Map your batch data. Find where batch numbers, dates and licence details live today, and who owns them.
Check your printers. Confirm each line can print a scannable QR code at normal line speed.
Run a pilot. Code a few real batches early, scan them on ordinary phones, and fix what breaks.
Where Zelthy fits
Zelthy CodeSure is our QR code solution for India's Schedule H2. It creates a code for each batch, takes in batch data from your line printer or a simple upload, adds a QA approval step before a batch goes live, and gives you a branded verification page and scan reports. It works alongside your existing printing setup, supports compliance with Rule 96 of the Drugs Rules, 1945, and can be live in about seven days. It runs on the Zelthy platform, which pharma companies including MSD, Roche and AstraZeneca use for their operations.
Not sure where you stand? Send us one current label from a covered product. We'll tell you what would need to change, at no cost. Talk to us.
One scan shows the product and batch details behind the code.
Frequently asked questions
Is a QR code mandatory on all medicines in India?
No. It applies to the 300 brands already listed in India's Schedule H2 and, from 2027 and 2028, to all vaccines, anticancer drugs, NDPS drugs and antimicrobials. Other products can carry a code voluntarily, according to CDSCO.
What does the QR code carry, and where does it go?
Product and batch details such as a unique product identification code, generic and brand names, manufacturer name and address, batch number, manufacturing and expiry dates, and manufacturing licence number. It goes on the primary pack label, or on the secondary pack if the primary label has no room, as explained in CDSCO's FAQs on the QR code requirement.
Is my product an antimicrobial?
Antibiotics are the obvious case, but the notification covers "all antimicrobials", which is a wider group. Check borderline and combination products against the notification with your regulatory team.
We are a contract manufacturer. Does this affect us?
The code is printed on your line, so expect your brand-owner clients to ask whether you can handle it. Agree early with each client and your QA team who supplies the code data and who approves it.
Zelthy CodeSure is pharma's Schedule H2 QR code solution for India. It creates a code for every batch, takes in batch data from your line printer or a simple upload, and adds a QA approval step before a batch goes live. It supports Rule 96 compliance ahead of the 1 July 2027 and 2028 deadlines and can be live in about seven days, on the platform that MSD, Roche and AstraZeneca use.
