Product Label Compliance Review for Drugs, Cosmetics and Medical Devices
A label that misses one prescribed detail can make a product “misbranded” under the Drugs and Cosmetics Act, 1940. We check your artwork line by line against the Drugs Rules, 1945, the Cosmetics Rules, 2020, the Medical Devices Rules, 2017 and the Legal Metrology packaging rules before it goes to print.
What it is
A label compliance review checks your carton, label and leaflet artwork against the rules on what must appear on the pack and what must not be claimed. The output is a marked-up artwork and a checklist of every required particular, with the rule it comes from.
Four sets of rules usually apply. Drugs follow Rules 96 and 97 of the Drugs Rules, 1945. Cosmetics follow Rule 34 of the Cosmetics Rules, 2020. Medical devices follow Rule 44 of the Medical Devices Rules, 2017. On top of these, retail packages must carry the declarations in Rule 6 of the Legal Metrology (Packaged Commodities) Rules, 2011. Section 17(b) of the Drugs and Cosmetics Act treats a drug “not labelled in the prescribed manner” as misbranded; Section 17C(b) does the same for cosmetics.
Who it applies to
You make or market drugs
Units holding a drug licence, loan licensees and brand owners. A Faridabad marketer launching its first Schedule H tablet through a loan licensee needs the right Rx warning, licence number and manufacturer details from day one.
You sell or import cosmetics
D2C brands, contract manufacturers and importers. Say a Delhi brand imports a serum from Korea: each unit pack needs the “RC” number and the importer’s name and address.
You make or import medical devices
Manufacturers and importers of devices and IVDs, including those holding medical device registration, that must show the licence number, batch, expiry or shelf life, sterility and single-use status.
Why it matters
Avoid scrapping a print run
A wrong licence number found after the print run means scrapping cartons or over-stickering stock. Checking the proof costs far less.
Stay clear of seizure and prosecution
Drug inspectors and Legal Metrology officers check labels when they sample products. A misbranded product can be seized.
Get through buyer and marketplace checks
Marketplaces, pharmacy chains and hospital buyers often check licence numbers and MRP first.
What each label must show
| Particular | Drugs (Rule 96) | Cosmetics (Rule 34) | Medical devices (Rule 44) |
|---|---|---|---|
| Product name | Proper name, more conspicuous than the trade name | Name of the cosmetic | Name of the device and details to identify it and its use |
| Batch | Preceded by “Batch No.” or “B. No.” | Preceded by “B” or “Batch No.” | Batch or lot number |
| Licence number | “Mfg. Lic. No.” or “M.L.”; import licence number for imports | “M” or “M. L. No”; “RC” number for imports | Manufacturing or import licence number |
| Dates | Date of manufacture and expiry, expiry not more than 60 months from manufacture | Use before or expiry date (month and year) | Month and year of manufacture and expiry, or shelf life |
| Other | Active ingredient content, net contents; Rx symbol and warning for Schedule H, H1 and X (Rule 97) | Ingredient list; false or misleading claims barred (Rule 36) | Storage conditions, warnings, sterile and single-use status |
Retail packages also need the Legal Metrology declarations: manufacturer or packer, net quantity, month and year of manufacture, MRP inclusive of all taxes, consumer care details and, for imports, country of origin.
Documents required
Artwork
- Artwork of every pack component: label, carton, leaflet
- Pack sizes and SKUs
- Any stickers used on imported stock
Licences and registrations
- Drug manufacturing or loan licence, or import licence
- Cosmetic manufacturing licence or import registration certificate
- Medical device manufacturing or import licence
- LMPC registration certificate, if you pack or import
Product details
- Composition or full ingredient list with percentages
- Schedule classification for drugs
- Device class and intended use
- Every claim you plan to print, with your supporting data
How it works
Confirm what the product legally is
We confirm which rules apply. Here is the catch: a skin cream with an antifungal ingredient may be a drug, not a cosmetic, and the whole label changes with it. Your regulatory team confirms the classification.
Build a rule-wise checklist
Our label compliance review lists every mandatory particular, including the Legal Metrology declarations and schedule-specific warnings.
Mark up every panel of the artwork
We return comments on each panel: what is missing, what is worded wrongly and which claims need support.
Re-check the final print proof
Your designer revises the artwork. In practice, errors creep in between drafts, so we check the final print proof once more.
Timelines
Clear the label before the first print run
Labels must comply before the product is sold. Do the label compliance review at artwork stage, not after printing.
Register for LMPC within 90 days
Anyone who pre-packs or imports commodities for sale must apply for LMPC registration under Rule 27 of the Packaged Commodities Rules within 90 days of starting, with a ₹500 fee.
Print QR codes on Schedule H2 brands
Since 1 August 2023, the 300 drug brands listed in Schedule H2 must carry a bar code or QR code with eight data points, including the unique product identification code, batch number and expiry date.
What happens if a label is wrong
Drugs: prosecution under Section 27(d)
Selling a misbranded drug can attract imprisonment of one to two years and a fine of at least ₹20,000 under Section 27(d) of the Drugs and Cosmetics Act, 1940.
Cosmetics: Section 27A
Selling a misbranded cosmetic can attract imprisonment of up to one year, a fine of up to ₹20,000, or both.
Legal Metrology penalties
Under Section 36(1) of the Legal Metrology Act, 2009, a package without the prescribed declarations attracts a fine of up to ₹25,000 for a first offence.
Frequently asked questions
Which rule governs drug labelling in India?
Rule 96 of the Drugs Rules, 1945 sets the core particulars for drug labels, and Rule 97 adds the Rx symbol and warnings for Schedule H, H1 and X drugs. Rule 96 covers the proper name, net contents, active ingredient content, manufacturer details, batch number, licence number and dates. Imported drugs also show the import licence number and the importer’s name and address. Follow both rules and the label is complete.
What must a cosmetic label show under the Cosmetics Rules, 2020?
Rule 34 requires the name of the cosmetic, the manufacturer’s name and address, the use-before or expiry date, a batch number preceded by “B” and the manufacturing licence number preceded by “M”. Imported cosmetics show the “RC” registration number and the importer’s name and address. Ingredients above 1% are listed in descending order. With these in place, the core of the label is covered.
Are small cosmetic packs exempt from some label details?
Yes, partly. For small packs, up to 60 ml for liquids or 30 g for solids, Rule 34 relaxes some details. The address can be shortened to the manufacturer’s name and principal place with pin code, and the ingredient list may be left off the pack. The batch number can be dropped only on packs of 10 g or 25 ml and below. The “RC” number on imported packs still applies. We confirm which relaxations fit your exact pack size before you finalise artwork.
What is the maximum shelf life I can print on a drug label?
Under Rule 96, the expiry date on a drug label cannot be more than 60 months from the date of manufacture. Both dates must appear, and the shelf life you claim must be backed by your stability data. Keep the printed expiry within 60 months and within that data, and the label is fine on this point.
Which drugs need a QR code on the label?
The 300 brands listed in Schedule H2 must carry a bar code or QR code since 1 August 2023. The code must hold eight details: unique product identification code, proper and generic name, brand name, manufacturer name and address, batch number, date of manufacture, date of expiry and manufacturing licence number. If your brand is not in Schedule H2, a QR code is optional, so check the current list before you decide.
Does a medical device label need the licence number?
Yes. Rule 44 of the Medical Devices Rules, 2017 requires the manufacturing licence number for domestic devices, and the import licence number with the importer’s name and address for imported ones. The label must also show batch or lot number, manufacture and expiry dates or shelf life, and any warnings. For very small devices, Rule 44 allows a shorter set of particulars, which we check for you.
Can I make claims like “dermatologically tested” on a cosmetic?
Only if the claim is true and you can support it. Rule 36 of the Cosmetics Rules, 2020 bars any claim that is false or misleading, and Section 17C treats a cosmetic with a misleading label statement as misbranded. Keep the test reports or study data behind each claim on file. We flag claims that look risky, and your regulatory or R&D team confirms the evidence.
Do Legal Metrology rules apply to medicines and cosmetics too?
Yes, for retail packages. Rule 6 of the Legal Metrology (Packaged Commodities) Rules, 2011 requires declarations such as net quantity, month and year of manufacture, MRP inclusive of all taxes and consumer care details. These sit alongside the drug, cosmetic or device rules, not in place of them. Our checklist covers both, so one review takes care of the whole pack.
What does Taxhint check, and what stays with my team?
We check the artwork against the labelling rules and return a marked-up proof with a rule-wise checklist. Product classification questions, stability data, test reports and claim evidence stay with your quality and regulatory team, and any testing is done by approved laboratories. Final approval of the artwork is yours. That way, every line on the pack has someone who checked it.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
A label compliance review carries no government fee. If you also need LMPC registration, the fee under Rule 27 is ₹500, and ₹100 for an alteration.
Ready to begin?
Send us the artwork and your licence copies, and we will return a marked-up proof with every gap listed against its rule.