Only Licensed Importers Can Overprint Labels Under Rule 104A, Clarifies CDSCO
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has clarified that overprinting or stickering of drug products under the Drugs Rules, 1945, is strictly permitted only for imported drugs. This labeling activity must be carried out exclusively by the importer holding a valid manufacturing license in their name.
On May 26, 2025, the apex drug regulatory body issued a new Office Memorandum clarifying the regulatory conditions for overprinting, stickering, and labeling of imported drug products under Rule 104A of the Drugs and Cosmetics Rules, 1945.
Rule 104A of the Drugs and Cosmetics Rules, 1945 prohibits any person from altering, defacing, or removing inscriptions or marks made by the manufacturer on a drug’s container, label, or wrapper. However, the rule allows exceptions where such alterations are made with the prior approval or direction of the Licensing Authority.
Previously, importers were required to submit separate applications for each drug to obtain permission for such label modifications—whether for overprinting, stickering, or adding supply-specific details.
The recent directive follows an earlier memorandum issued on 29 January 2020, and is aimed at streamlining implementation across license holders and importers.
In its Office Memorandum dated January 29, 2020, the CDSCO had announced a procedural simplification allowing importers to obtain a single, comprehensive permission for overprinting, stickering, or stamping of all imported drug products, rather than applying individually for each item. This permission, however, applies only to drugs not intended for sale, such as those used in hospitals or institutions, government supply, physician’s samples, managed access programs, clinical trials, or post-trial access. Labeling must be done at a licensed manufacturing site, without obscuring the original label, and subject to SLA approval.
As per the recent clarification, the activity of labeling, overprinting, or stickering under Rule 104A is strictly permitted only for imported drugs. Such activities:
1. Must be carried out by the importer under a valid manufacturing license in their name.
2. Require the licensee to have adequate facilities for storage, labeling, and ancillary operations.
3. Must include at least one manufacturing and one QA personnel, as approved by the State Licensing Authority (SLA).
4. Do not require a dedicated Quality Control (QC) laboratory or personnel for such labeling purposes.
The memorandum also emphasizes that label modifications must:
“Comply with the current provisions of the Drugs and Cosmetics Rules” and “must not conceal the original label.”
It adds that, “The license number and the activity carried out for this purpose should also be mentioned beside alterations made as per Rule 104A.”
To illustrate proper labeling practice, the CDSCO gives an example, say, if the drug is for Central Government Health Scheme (CGHS) supply and that is to be written on the label, then the additional information to be added on the label as "CGHS Supply" "Overprinting done under Lic. No. MH/....A".
The clarification is addressed to all stakeholders and posted on the CDSCO website for immediate compliance.
Also Read: CDSCO Panel Approves Fabrazyme Label Update, Asks Sanofi to Submit EMA Nod
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