Important : Union Health Ministry mandates QR codes on 300 life-saving medicines
By: Pune Pulse
August 8, 2023
Pune: To combat the issue of counterfeit drugs and ensure the authenticity of medicines, the Union Health Ministry has given strict orders to make it mandatory for having QR codes or barcodes on the packaging of 300 medicines coming under Schedule H.
Speaking to Pune Pulse, Shyam Pratapvar, Assistant Commissioner, Food & Drug Administration, Pune said, “The central ministry has extended the deadline of QR codes/barcodes on medicine packaging to the year 2024. The batch of the medicines packaged & sold to retailers by manufacturers on & after the deadline in 2024 must have QR codes/barcodes on the packaging. If QR codes/barcodes aren’t found on the packaging of the batch of medicines sold on & after the date of implementation of this rule in 2024, strict action will be taken against the manufacturer. The nature of the action will depend on how many times this has happened from the manufacturer. If this happens only one or 2 times from the medicine manufacturer, he/she would be let off with a warning to not repeat this. If this happens frequently from the manufacturer, his/her license could be suspended as well.”
Earlier, the deadline for the same was August 1, 2023.
As per information, the union health ministry has mandated compulsory quick response (QR) codes or barcodes on the packaging of 300 lifesaving drugs that fall under Schedule H, which means they require a prescription. Some of the commonly used ones are Allegra, Augmentin, Shelcal, Azythral, Calpol, Dolo, Fabiflu, Meftal Spas, Montair and Pan D.
Stricter rules will mandate QR codes on drug packaging, ensuring authenticity and transparency. The Ministry updated the Drugs Rules of 1945 to enforce accurate labelling and authentication, promoting accountability. Manufacturers must include QR codes on labels for specified drugs, deterring counterfeits and enhancing transparency. Major companies embrace QR codes; smaller firms may need 30-60 days for compliance. Experts hail the move for better drug quality, safety, and consumer trust.
Around 300 drugs, ranging from antipyretics like Dolo to antibiotics like Azithromycin, will be required to carry a barcode on their packaging labels from 2024. In a move aimed at bolstering accountability and transparency within the pharmaceutical sector, the Ministry of Health and Family Welfare announced significant amendments to the existing Drugs Rules of 1945 on November 17, 2022. These amendments, published under the title ‘Drugs (Eighth Amendment) Rules, 2022,’ entail a series of measures to ensure the authentication and accurate labelling of drug formulation products.
Key among the amendments is the requirement for manufacturers of drug formulation products, as specified in Schedule H2, to incorporate a Barcode or Quick Response Code onto their packaging labels. This code will store critical data and information that can be verified using specialized software. The stored data within the code includes vital details such as the product’s unique identification code, proper and generic name, brand name, manufacturer’s name and address, batch number, date of manufacturing, date of expiry, and manufacturing license number. This move not only enhances transparency in the pharmaceutical supply chain but also serves as a deterrent against counterfeit or substandard drugs entering the market.
