To curb the menace of spurious medicines, the government is finalizing the process of mandating that pharmaceutical companies print barcodes on the packages of 300 drug formulations so that information such as a manufacturing license and batch number can be accessed upon scanning.
The amendments to the Drugs and Cosmetic Rules, 1945, which, once approved, will come into force from May next year.
“A sizable number of the drugs mentioned in the list are mostly bought over the counter, exposing people to the possibility of consuming counterfeit medicines.” “This amendment aims to prevent the supply of fake medicines and ensure improvement in public healthcare,” an official source told PTI.
“A barcode or QR code will authenticate whether a particular drug is original or not,” the official added.
In June, the Union Health Ministry issued a draft gazette notification on the subject, seeking public comments and feedback.
The ministry is in the process of finalizing it based on the comments and further deliberations.
Manufacturers of 300 drug formulation products listed in Schedule H2 of Rule 96 of the Drugs and Cosmetics Act will be required to print or affix a barcode or quick response code to their primary or secondary packaging label that stores data or information legible with a software application to facilitate authentication.
An identification code, the proper and generic name of the drug, the brand name, the name and address of the manufacturer, the batch number, the date of manufacture and expiration, and the manufacturing license number shall be stored as data or text information.
In the first phase, 300 drugs from top pharma brands with approximately 35% of the total market share will be brought under this ambit, and all drugs may be covered by December of next year.
The Drugs Technical Advisory Board (DTAB) met in November 2021 and recommended that the top 300 drug formulation brands include a barcode or QR code.