Last Updated on June 16, 2025 by The Health Master
CDSCO
Download the notification: Recently, Central Drugs Standard Control Organisation (CDSCO) notified certain clarifications regarding the labeling and overprinting of drugs imported into the country, which should clear up any confusion for those in the industry and help facilitate the needs of essential drugs to be more easily sought after in import.
This clarification of comprehensive permission for products imported for overprinting, stickering, or stamping as per Rule 104 was issued on 26-05-2025.
What is the clarification?
Through an office memorandum issued September 20, 2023, CDSCO states that overprinting, stickering, or labeling shall be “strictly allowed only for import of drugs” if these drugs are imported under the Drugs Rules, 1945.
Important to clarify is that for this activity to occur, it must be done by the importer for him/herself, AND it requires a valid manufacturing license in the name of the importer.
What are the requirements?
To justify the trust in Indian drug operations activity by giving a legitimate requirement, Drugs Controller General (India) Dr. Rajeev Singh Raghuvanshi stated the following must occur:
- Facility/Storage: importer must have a facility with adequate storage/completion of required activities.
- Ancillary area: compliance supporting areas.
- Labeling Facility: in-house facility for overprinting, stickering, etc.
- QA Person: At least one (1) Manufacturing and QA personnel will be assigned under the task. This must be approved by SLA.
- QC laboratory: Not required are Quality Control (QC) Laboratory and QC Laboratory personnel for this labeling activity—suggesting it’s a very narrow requirement for which this is allowed.
What should be on the Label ?
Additionally, the license number with which the activity occurs must also be represented on the label per Rule 104A. For example, if a drug is under CGHS supply, the label will read “CGHS Supply” and “Overprinting done under Lic. No. MH/….A”.
What is Rule 104A?
Rule 104A of the Drugs Rules, 1945, states that no person shall alter, obliterate, or deface any inscription or mark made upon any drug containers, labels, or wrappers by the manufacturer/body corporate unless permitted by the Licensing Authority.
Q: What’s the point of such clarification by CDSCO regarding drug labeling?
A: To clarify that overprinting and stickering are allowed for the purpose of importing drugs if it is done by the licensed manufacturer but with limitations and guidelines.
Q: What information needs to be mentioned on the altered label?
A: The license number under which the activity is carried out as per Rule 104A and it should be mentioned beside the alterations. e.g., “Overprinting done under Lic. No. MH/….A.”
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Delhi High Court: Cough Syrup Warning Labels Now Required
CDSCO Guidelines: Safe Disposal of Expired and Unused Drugs
India to Ban 34 Antimicrobials for animal use
USFDA approval granted for Amlodipine & Atorvastatin Tablets USP
USFDA issues warning on Allergy medicines
FSSAI: Food Labelling and Display – Chapter-18
42 Companies banned over supply of NSQ drugs: Rajasthan
83,090 Tablets of Alprazolam and Zolpidem Seized, 1 Arrested
High Salicylic Acid: India Halts Cosmetic Imports
