A missed opportunity for GS1 to explain why India’s barcoding programme is not a danger to society

A recent essay in Express Pharma by Mr. S. Swaminathan, CEO of GS1 India, extolled the benefits of the QR barcoding programme and its importance for protecting Indian citizens against the terrible menace of counterfeit medicines [1]. Launched by India’s Ministry of Health and Family Welfare in 2023, the QR programme soon began to suffer failures that have now been well documented [2]. It turns out that criminal cartels can easily hijack the programme, place fake QR codes on fake medicines and then, in a paradoxically cruel twist, lead consumers to believe those fake drugs are actually genuine [3].

India’s failed experiment on use of QR codes as an anti-counterfeiting tool, which had been widely criticized by global security experts, can be attributed to two causes — a poorly designed solution that adopted the well-known vulnerability of QR codes [4,5] combined with a regulatory mandate filled with serious loopholes. The resulting lack of clarity allowed many Indian drug makers to cut corners and roll out a programme that further exposed their products and bring serious harm to their patients. 

And now in a truly stunning development the very programme that earlier failed on both structural and operational grounds is being expanded to cover life-saving medicines that include antibiotics, vaccines and cancer drugs. The looming harm to India will be incalculable, a prediction that is not mere hyperbole but based on the very failures to which the same programme had earlier succumbed.

Those who proclaim India’s QR programme to be beneficial have not explained why a solution that aleady experienced serious failures should now be expanded to life-saving medicines that protect among the most vulnerable people in our society. And that is why the essay from GS1 was so disappointing because it was a missed opportunity to address the earlier fiasco head on. Instead, GS1 offered a pablum of false and dangerous claims that deserve a forceful response.

Here, I take up two of those claims and conclude by reexamining the principal motive for why GS1 continues to deceive the global public and India’s pharmaceutical industry in particular.

India does not have a drug traceability programme … and never will

The central argument offered by GS1 in support of expanding India’s QR coding directive is that it will allow drug packages to be tracked from plant to pharmacy. This claim is both false and dangerous. 

The Indian barcoding mandate, both in its original articulation [6] and recent expansion [7], contains no mention that medicine packages must be endowed with a unique serial number. Consequently, only about one-half of the drug companies that fell under the original mandate chose to print serial numbers, and the majority of them did not even do so on the primary package sold to consumers [8].

It is simply not possible to have a traceability (Track & Trace) programme without the foundational requirement for every drug package to have its own digital identity, a fact that GS1 knows very well. And in the absence of that mandatory requirement from the Health Ministry, India will simply be unable to implement a traceability programme. GS1’s claim that the government’s barcode mandate will usher in a new era of drug traceability is therefore demonstrably false.

It may be the case that GS1 has come to recognize the serious flaws in India’s mandate and therefore has used the theoretical possibility of future drug traceability as a means of rescue. This would be in keeping with its core mission to advance the standards it has developed in support of traceability across healthcare supply chains. However, any effort to persuade India into making yet another attempt at implementing drug traceability is not only disingenuous, because of the absence of mandatory serialization, it is actually dangerous.

India has seen the drug traceability movie before. Starting around 2011, the Ministry of Commerce collaborated with GS1 to issue a compulsory requirement for all drug exporters to install a Track and Trace system. That effort suffered one setback after another. The Indian government quietly pulled the program last year after more than a decade of effort [9]. The factors that led to this collapse were known (or should have been known) to GS1 at the very outset, given its leadership in the field of drug traceability.

GS1 now continues to promote the same dishonest claim, as it did back in 2011, that a drug traceability programme can be implemented in India and other emerging markets. I have recently offered evidence-based arguments that a traceability programme will in fact never work in the Indian domestic context due to the size, complexity and operational facets of its drug supply chain [10]. There has been no effort by GS1 or its enablement partners to rebut those arguments and explain why such a renewed effort, now at much larger scale across the entirety of India’s drug manufacturing landscape, would overcome the inherent structural and operational challenges of its supply chain.

GS1’s inability to explain exactly how an Indian traceability programme can succeed, rather than just offering superficial sermons on its benefits, actually creates substantial peril for India, as I explain next. 

India’s expanded QR programme will bring immense harm to its people and the drug industry

GS1 is a prominent organization that enjoys access to and influence on policy makers. Consequently, its claim that QR coding will lead to drug traceability becoming an imminent reality carries considerable adoption resonance across both government and industry. The certainty of great harm to India in that event will come in two forms.

The first is economic harm, which will be manifested through the substantial capital investments and ongoing costs that will be necessary on the part of Indian drug makers [11]. GS1 makes the case that many plants have already invested in machinery to print and scan barcodes on drug packages, which is the necessary first step in a traceability regime. That is certainly true. However, what is not mentioned is that India’s barcoding expansion will now affect nearly every single drug manufacturer, including the many hundreds (possibly thousands) involved only in domestic sales and which had no prior requirement to make any investments in online barcode printing and vision inspection equipment.

Those companies will now have to install print-and-inspect machinery that can easily exceed twenty thousand dollars per line along with significant operating costs to maintain an IT programme that must also include perpetual payments to GS1 for use of its proprietary coding formats. GS1’s continuing campaign for India to yet again embark on a massive effort to resurrect its traceability dream will come at steep cost to the industry. And as before, it will be the pharmaceutical industry, including now the legions of SMEs that are the backbone of India’s drug supply, who will be coerced into making those massive investments toward a failed cause.

The economic harm from the programme will however be overshadowed by the personal harm to consumers who will continue to suffer under ineffective protection from those very barcodes. To make matters worse, it has now been established that consumers can be misled into believing a fake drug is actually genuine due to the cunning way that counterfeiters have been able to hijack Indian’s current system [12]. That false reassurance to patients is really the worst outcome in this scenario because it will lead to a maddening aftermath where ensuing medical failure from a fake drug is what will cause it to be detected rather than the government-mandated QR code.

Consider for a moment the impact of that outcome. The current QR coding programme was launched to protect the top 300 selling medicines as a way to test the system. Fake QR codes then quickly appeared on fake medicines for treatment of high blood pressure [13], diabetes [14], blood clotting [15], vertigo [16] and epilepsy [17]. Four of these products belonged to drug makers that opted to follow a QR coding format designed by GS1, whose lobbying efforts now argue for the same programme to encompass highly sensitive life-saving medicines. These medicines — antibiotics, cancer drugs and vaccines — are among the most counterfeited because they are specifically so lucrative to the criminals [18-20]. And yet, all formulations that fall under those very broad categories, all of them, will soon become even more vulnerable due to the same weakness that plagued earlier barcoded products.

And that is why expanding India’s barcoding programme is such a danger to public safety.

A betrayal of trust

We are thus left with two troubling facts — QR coding is unarguably a dangerous anti-counterfeiting solution and that any claim for its use in drug traceability is highly specious because such a programme can never be successfully implemented in India. As it turns out, the major beneficiary in both arms of that equation is GS1 itself. How? 

The answer comes from the business side of traceability. GS1 doesn’t just publish a set of standards and leave it at that but additionally has created a business structure that requires companies to pay into it to use their protocols, starting with an initial requirement to enroll into its ecosystem followed by perpetual subscription and other fees [21,22]. GS1’s business operations even extend to the very way that QR code content is structured. A new web-based protocol has been defined by GS1, known as Digital Link, in which product information can be retrieved by way of a QR code that is structured around its proprietary syntax [23]. In fact, the Indian affiliate of GS1 claims that it is the only authorized source for barcodes in the country [24].

So, the revenue to GS1 is accrued first by way of its proprietary QR coding structure, which it argues would then set the stage for a nationwide traceability programme. Both the problematic nature of QR codes and the unfeasibility of drug traceability in India make this a nakedly deceptive proposition, and one that is made worse by a troubling conflict of interest. An organization cannot simultaneously be responsible for issuing traceability standards or creating QR code designs whose adoption is then assured through its relationship with policy makers to in turn earn it vast sums of money. That is unarguably the very definition of conflict of interest because the financial benefit that GS1 accrues is a direct outcome of its government access [25].

GS1’s business agenda can therefore be in stark contradiction to a nation’s goal to protect its citizens, as evidenced by a dreadful outcome that can be directly attributed to its earlier actions. GS1’s advocacy that a drug traceability programme would solve the counterfeiting problem in Africa led the Indian government to adopt that approach and abandon more effective solutions that were readily available back in 2011. As a result, African nations continued to suffer from the epidemic of counterfeit drugs, which only continued to grow over the past decade to become a public health crisis that according to the United Nations now kills more than half a million people annually [26-28].

During that period, Africa remained helpless in the face of continued penetration of fake drugs. And given its role as the largest supplier of medicines to sub-Saharan Africa [29], India was uniquely positioned to greatly reduce suffering and save lives there over the past decade. And that is the tragedy of it all — the devastating consequence on African humanity from India’s decision to adopt GS1’s arguments and roll out a drug traceability programme that never had any chance of success.

Summary

India is dealing with a serious and growing drug counterfeiting problem that deserves thoughtful analysis and discourse. However, neither GS1 nor its business enablement partners have yet provided an intellectually rigorous argument for why India’s expanded barcode programme will now suddenly be immune to its past problems.

To the contrary, there is now considerable evidence of the economic harm to Indian industry and personal harm to its citizens. In fact, each and every stakeholder across the full pharmaceutical ecosystem — drug makers (both small and large), wholesalers, pharmacists, clinics, healthcare personnel and most notably patients — will face undeniable harm at some point from the effects of expanding the barcoding mandate.

GS1 can, and should, play a role in this debate and yet has curiously avoided answering some key questions previously directed at it [30], as follows:

How does GS1 justify use of a system that can be so easily compromised such that fake QR codes on fake medicines have become widespread and actually provide false reassurance to patients?

Why does GS1 continue to promote traceability (Track & Trace) to combat drug counterfeiting in light of the past failure in India and the severe operational constraints in that market?

How does GS1 reconcile the conflict of interest between developing traceability standards and then pursuing government advocacy for its adoption in light of the business benefits it can later derive?

A broad-based evidence-driven public discussion is now necessary to do what is right by India and bring forth an enduring era of patient safety — something that will not be met through the absence of honest leadership from organizations such as GS1.

References

[1]https://www.expresspharma.in/traceability-pays-back-in-many-ways/

[2]https://www.expresspharma.in/a-troubling-new-development-in-indias-qr-code-saga/

[3]https://app.box.com/s/4njfkz8ued1u7wcokv5z9ge1xq4ltw6x

[4]https://threatpost.com/fbi-malicious-qr-codes/177902/

[5]https://consumer.ftc.gov/consumer-alerts/2023/12/scammers-hide-harmful-links-qr-codes-steal-your-information

[6]https://app.box.com/s/zwzp60rat9p9rdrl5duof8v28lzkgi0j

[7]https://app.box.com/s/q4yiceku0z0b7t2axhzsobdaq096jnr5

[8]https://app.box.com/s/tgy8xc223rxtxzfminufo2pr31q8f522

[9]https://pib.gov.in/PressReleseDetailm.aspx?PRID=2098042®=3&lang=1

[10]https://www.expresspharma.in/the-myth-of-drug-traceability-in-india/

[11]https://medwinpublishers.com/OAJPR/current-status-and-challenges-of-serialization-in-pharma-industry.pdf

[12]https://www.expresspharma.in/sun-pharma-must-immediately-declare-a-voluntary-recall-of-levipil-500/

[13]https://indianexpress.com/article/cities/ahmedabad/fake-nicardia-retard-10-racket-gujarat-police-10852207/

[14]https://www.medindia.net/news/bitter-pill-who-warns-of-fake-diabetes-drugs-216140-1.htm

[15]https://indianexpress.com/article/cities/delhi/counterfeit-medicines-worth-over-rs-2-5-lakh-seized-from-delhi-wholesaler-9944475/

[16]https://drugscontrol.org/news-detail.php?newsid=42246

[17]https://medicaldialogues.in/news/industry/pharma/fake-levipil-500-tablets-posing-as-sun-pharma-product-seized-in-telangana-162709

[18]https://www.cdc.gov.au/newsroom/news-and-articles/fake-rabies-vaccines-india

[19]https://www.independent.co.uk/asia/india/fake-drugs-racket-delhi-johnson-johnson-gsk-b2803425.html

[20]https://gh.bmj.com/content/10/6/e017078

[21]https://www.gs1india.org/wp-content/uploads/2022/07/GST-Certificate-37.pdf

[22]https://www.gs1india.org/content/register-for-barcodes/

[23]https://ref.gs1.org/docs/2023/QR-Code_powered-by-GS1-best-practices

[24]https://www.gs1india.org/blog/know-all-about-barcode-authentication/

[25]https://app.box.com/s/kj916h3mmr3n1vxgr5y0vl26bpko97ze

[26]https://news.un.org/en/story/2023/02/1133062

[27]https://www.bbc.com/news/world-africa-53387216

[28]https://www.theguardian.com/world/article/2024/aug/04/fifth-of-medicines-africa-substandard-fake-research

29]https://www.thebureauinvestigates.com/stories/2025-04-16/indias-drugs-industry-global-medicine-market

[30]https://www.expresspharma.in/a-defining-opportunity-for-clarity-from-gs1/

The post A missed opportunity for GS1 to explain why India’s barcoding programme is not a danger to society appeared first on Express Pharma.