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The Union health ministry's proposal to expand India's mandatory QR barcoding program to include critical drug categories, such as vaccines, anti-infectives, and anti-cancer medicines, has been met with a scathing critique.
The feedback, submitted in response to Notification 757 (E) by retired Canadian scientist and Overseas Citizen of India, Dr. Avijit Chaudhuri, asserts that the current system is fundamentally flawed and that its expansion would be far worse for public safety. Dr Chaudhuri, who helped introduce serialization to Indian pharma in 2007, argues that the current programme is not an effective product security tool but rather a vehicle to empower counterfeiters.
A central point of the opposition is the government's choice of an open QR code format, which allows an inserted link to act as the gateway for verification. Dr Chaudhuri emphasizes that open QRs are typically only used for marketing purposes and are extremely vulnerable to multiple attack vectors. Citing warnings from major US federal agencies like the FBI and FTC, the critique notes that ‘there are no product security programmes anywhere, much less one to stop counterfeit drugs, that are based on open QR codes. In contrast, closed formats that require a dedicated reader or mobile application, such as UNICEF's TRVST system, are considered more secure.
The security concerns are not merely theoretical, the document details several instances where the current programme has already been compromised in just a matter of months. Fake QR codes have been discovered on counterfeit drugs across India, including those for treating high blood pressure, diabetes, blood clotting, vertigo, and epilepsy. The most notorious case involves Sun Pharma's epilepsy drug, Levipil, where a sophisticated cybercrime operation successfully procured and used large numbers of genuine serial numbers on fake versions of the drug. Dr Chaudhuri notes that drug companies have provided no guidance on what actions to take when their QR programme has been compromised.
Perhaps the most alarming flaw is the illusion of false reassurance created for patients. Despite the Levipil counterfeiting being known for months, scanning the QR code on a fake package still returns the declarative statement, ‘This is a Genuine Pack’, and displays all the key product details, just like the genuine drug. The author calls this a stunning level of incompetence (or indifference) on the part of the drug maker. Dr Chaudhuri warns that this failure provides the strong impression that the fake product is authentic and would be far more devastating if applied to life-saving medicines.
The current regulation suffers from additional serious flaws, notably failing to mandate a unique serial number, which has led more than one-third of drug makers to opt for less secure batch number coding instead. This scheme makes detecting fake products negligible because thousands of packs share the same code. Furthermore, for many drugs like the highest-selling Augmentin Duo, the QR code is missing from the consumer-facing product (blister strip) and only appears on the secondary polycarton. This exemption creates an ideal scenario for counterfeiters to distribute fake blister strips with full knowledge that even genuine blisters lack any means for consumer verification.
The expansion, if implemented with the current platform, is predicted to harm virtually every stakeholder in the ecosystem. Small and Medium Enterprises (SMEs) would face unsustainable, disproportionate, and discriminatory costs for compliance, potentially forcing them to cut corners on Good Manufacturing Practices (GMP). Pharmacists and Wholesalers would bear the brunt of customer outrage for selling fake, QR-laden medicines. Doctors and Nurses would also face substantial personal and professional harm if they administer a fake vaccine, authenticated by a fake QR code, that leads to an adverse outcome or death.
Dr Chaudhuri concludes by urging the government to recognize that a platform co-opted by criminals has abdicated the right to claim success of its regulated solution. He insists that the programme must be revised or replaced with an effective, enduring and economical solution that also eliminates the economic discrimination against SMEs. He has published a framework for such a plan to serve as a starting point for discussion and debate. The paper’s firm stance is summarized with the final warning, the current failure "must not stand."
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