Small and mid-sized pharma firms rush to incorporate QR codes on drugs as government makes authentication mandatory

You can now check the QR code on your medicines to ensure their authenticity. As the central government introduces stricter regulations for drug authentication and transparency by imposing mandatory QR codes on drugs, effective from August 1, mid and small-sized pharmaceutical companies are rushing to incorporate the codes to ensure smooth sales.

Around 300 drugs, ranging from antipyretics like Dolo to antibiotics like Azithromycin, are now required to carry a barcode on their packaging labels, starting August 1. 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 specialised 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.

"The majority of big pharmaceutical companies have already implemented the codes, demonstrating their foresight about the rule's imminent effectiveness. While these regulations are now in force, smaller companies could potentially experience a decline in sales. It's anticipated that these companies might require around 30 to 60 days for the necessary processing to adhere to the new requirements," said Rajeev Singhal, Secretary, All India Organization of Chemists & Druggists (AIOCD). "Those who have not incorporated the QR code, we have requested them to do it as soon as possible, owing to sale issues through chemists," he said.

The aim is to provide a comprehensive tool for product authentication and to facilitate easy access to essential details for regulatory authorities, healthcare professionals, and consumers alike. The pharmaceutical industry believes that these amendments mark a significant stride towards ensuring drug quality and safety.

"We applaud the Government’s efforts to strengthen and safeguard the quality of medicines in the OTC sector through the introduction of QR codes, which confirm that products are genuine and can be fully trusted. This move is critical as it provides consumers with accurate information about the medicines purchased. It also helps to enhance consumer literacy and build consumer trust," said Sandeep Verma, Country Head, Bayer Consumer Health India. "The inclusion of QR codes can streamline the tracking and tracing of spurious drugs and protect customers from buying fake products. We look forward to working together with the government to ensure complete compliance with these new regulations and will actively help to create a safer marketplace for all parties," he said.