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CDSCO clarifies provision for over-printing or stickering will be allowed only for imported drugs
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Gireesh Babu, New Delhi
May 29 , 2025
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The central drug regulator has clarified that the overprinting or stickering of products under the provisions of Drugs Rules, 1945, will be strictly allowed for import of drugs and to be carried out by the importer under a valid manufacturing license in their name.
The clarification is in continuation to the regulator's office memorandum in the year 2020, allowing importers to seek comprehensive permission for several products instead of seeking permission each time, for specific purposes.
The Central Drugs Standard Control Organisation (CDSCO), in a latest office memorandum, clarified that the activity of labelling or over printing or stickering etc., on the label of the drug, under Rule 104A of the Drugs Rules, 1945, "is to allow strictly only for import of drugs."
All such activities to be carried out by the importer under a valid manufacturing license in their name.
"The Licensee shall have adequate facility or storage, ancillary areas, labelling facility etc. and will appoint at least one manufacturing and QA personnel to the satisfaction of the SLA. The QC Laboratory and personnel may not be required for such labelling activities," added Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India).
The labelling shall comply with the current provisions of Drugs and Cosmetic Rules. This activity will not conceal the original label. The license number and the activity carried out for this purpose should also be mentioned beside alterations made as per Rules 104A, added the regulator.
For example, 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", said the DCGI.
The Rule 104A of the Drugs Rules details about the prohibition against altering inscriptions on containers, labels or wrappers of drug. It elaborates that no person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any drug.
However, there is a provision that nothing in this rule shall apply to any alteration, any inscription or mark made on the container, label or wrapper of any drug at the instance or direction or with the permission of the Licensing Authority.
The importer had to make applications separately for each drug for the grant of permission under this provision for making alterations for various purposes.
In an OM on January 29, 2020, the CDSCO said that in order to simplify the procedure and to reduce the transaction time, it has decided without prejudice to legal provisions that for drugs imported into the country, the importer can seek a comprehensive permission for all such products imported by the importer for overprinting or stickering or stamping, instead of seeking permission each time.
However, this is applicable to only those drugs imported for the purpose of hospital or institution or government supply, for physician's sample, and for manage access programme or clinical trial use or for post trial access, all of them "Not to be Sold".
It also said that this comprehensive permission should be for labelling activity carried out at the licensed manufacturing premises without concealing the original label, subject to satisfaction of concerned State Licensing Authority (SLA).
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