After cancer drug counterfeiting scandal, India imposes new tracing requirements

India has introduced new tracing requirements for cancer drugs following a widespread counterfeiting scandal that exposed vulnerabilities in its pharmaceutical supply chain. Starting in July, manufacturers of all cancer drugs sold in the country will be required to add a QR code or barcode to their packaging. These codes will show the medicine’s journey from factory to patient, enhancing transparency and helping authorities combat the illegal trade of counterfeit medications. The move comes after investigative reports revealed how criminal networks exploited the high cost of life-saving treatments like Keytruda, a brand-name immunotherapy used for various cancers. According to findings from The Indian Express and the International Consortium of Investigative Journalists, counterfeiters in India stole empty vials of Keytruda from hospitals and pharmacies, refilled them with cheaper antifungal drugs, and sold the altered products at a fraction of the real price. A 100-mg vial of Keytruda costs over 150,000 rupees, more than $1,500, which makes it unaffordable for many Indian families. The illicit activity extended beyond India's borders, with at least one Nepalese woman purchasing the fake medication from one of the accused individuals. In response to these incidents, India’s national drug advisory board convened an emergency meeting in August 2024. Meeting minutes disclosed that officials had learned of criminal activities involving hospital pharmacies in New Delhi, where unscrupulous actors colluded to refill empty vials of expensive anti-cancer drugs with counterfeit alternatives. As a result, the board recommended that all cancer drugs be added to a list of 300 medicines already subject to mandatory QR coding. This measure aims to create a robust track-and-trace mechanism for every vial and strip of medication available in the Indian market. Beyond cancer drugs, the requirement extends to other critical categories, including vaccines, antimicrobials, and narcotics. Each QR code must contain nine specific data points, such as the unique identification number of each unit, the manufacturing and expiration dates, and the name and address of the manufacturer. This level of detail is intended to make it harder for counterfeiters to replicate the authentication process successfully. Despite these measures, experts caution that the system is not entirely infallible. An unnamed industry analyst told The Indian Express that while the QR codes could deter some counterfeiters, they might still find ways to bypass the technology. For instance, using identical packaging could allow criminals to mimic legitimate products. However, the system could still serve as a deterrent if the fake product is logged into the tracking database before the genuine version reaches the market. Authorities are also working to strengthen enforcement mechanisms. Police in New Delhi recently arrested 12 men suspected of participating in the counterfeit Keytruda scheme. The suspects were reportedly involved in stealing empty vials from medical facilities and selling the altered drugs to unsuspecting patients. The arrests underscore the growing efforts by law enforcement to dismantle organized crime rings operating within the healthcare sector. Looking ahead, the government plans to expand the QR code initiative further, potentially incorporating digital verification systems that can be accessed through mobile applications. This would enable patients and healthcare providers to quickly verify the authenticity of a drug before administration. Such steps are expected to reduce the risk of counterfeit drugs entering the supply chain and protect vulnerable populations who rely on expensive treatments.