The Central Drugs Standard Control Organization (CDSCO) has issued a clarification regarding Rule 104A of the Drugs and Cosmetics Rules, 1945. It outlines that labeling, overprinting, or stickering of imported drugs is permitted only under a valid manufacturing license. The activity must not obscure original labels and must comply with regulatory standards, including proper mention of license numbers and labeling details.
The CDSCO, under the Directorate General of Health Services, has clarified the scope of Rule 104A of the Drugs and Cosmetics Rules, 1945. This rule permits labeling, overprinting, or stickering of imported drugs strictly under a valid manufacturing license held by the importer. The licensee must maintain adequate facilities and appoint qualified manufacturing and QA personnel. While QC labs are not mandatory, labeling must adhere to existing regulations and must not obscure the original product label. Any modifications must clearly mention the license number and the nature of the activity. For instance, if a drug is intended for CGHS supply, the label should state “CGHS Supply” and include the license reference for overprinting.