Viewpoint: The emerging barcode initiative for medicines in India - part 1

Part 1: How changes to the draft guidelines can set the foundation for a successful anti-counterfeiting programme

India is again on the cusp of introducing a new drug anti-counterfeiting programme, this time for domestic medicines. The current proposal comes a decade after the introduction of a similar programme that was mandated in 2011 for export drugs. The new initiative from India’s Ministry of Health and Family Welfare (MoHFW) sets out to amend the Drugs Rules (1945) by specifying a new set of requirements to be implemented by drug manufacturers and importers.

In this first of a three-part series, I describe the current draft regulation [1] and then offer thoughts on how it should be revised to ensure that an effective and enduring programme is ultimately created. The discussion will be centred on foundational principles, guided by what is actually printed or applied on the drug package, what data fields should be included, and how a small but important loophole in the current guideline can render the entire programme to be ineffective.

Programme scope

It is clear that the Indian government will take a gradual approach to product coverage, starting initially with an identified list of the top 300 drugs and then expand the range. It must be stated at outset that the Indian government is to be commended for developing a bold new initiative to protect the nation’s citizens against the peril of counterfeiting, diversion, and unauthorized sales. This new programme will become one of the largest regulatory mandates anywhere, eventually affecting hundreds of manufacturers and thousands of drugs, in a country soon to have the world’s largest population.

Although efforts to protect the domestic market have been in the makings since rollout of the export programme, the announcement in June this year has created sudden apprehension in different quarters, notably among drug manufacturers who are trying to understand the precise compliance requirements. The creation of any massive new programme must necessarily be an iterative process, and the Indian government has wisely issued a set of draft guidelines for now, with the expectation that thoughtful feedback from industry and specialists will help to refine the final regulations.

Data inclusion requirements in the draft proposal will be difficult to implement in current form

The MoHFW draft guidelines specify that eight different data fields be incorporated into a barcode to appear on medicine packages. These include:

• Unique product identification code                
• Proper and generic drug name
• Brand name                                                         
• Batch number
• Expire date                                                                          
• Manufacturer name and address
• Manufacture date
• Manufacturing license number

This breadth of data inclusion has created significant concern in terms of implementation. While some fields such as batch number would have a modest string length, the collective incorporation of all eight fields would require a barcode so large for readability that it would exceed available space on most packages. If the barcode were collapsed for space fitting, then the resulting pixel density would likely be so great as to make readability difficult in many cases.

Most solution specialists would recommend elimination of several of the proposed data fields, which in any case do not offer protective functionality against counterfeiting, and to instead incorporate only the key parameters that bring value in terms of a future authentication or traceability use case. It is now widely accepted that the following four data fields are crucial, and therefore have been used in other successful programmes:

• Product code (GTIN)                                          
• Batch number
• Expiry date                                                           
• Unique serial number

The question then arises as to how these different data fields should be embedded into a barcode, and what are the means by which software systems can delineate the information content. It would be impossible to make sense of the digital content without ability to parse the different fields. That issue is taken up in the next two sections.

Data formatting guidelines are absent in the draft proposal

The MoHFW draft guidelines simply stipulate that the eight defined data fields must be incorporated into a “Bar Code or Quick Response Code”. The latter, commonly abbreviated as QR code, is normally not used on pharmaceutical products but instead often found on consumer packages as a way to direct buyers to the brand or product website. QR codes became especially popular during the pandemic for allowing customers digital access to printed materials such as restaurant menus.

The standard data carrier for pharmaceutical products is the DataMatrix barcode — a two-dimensional code that allows high data density and therefore provides an ideal solution for marking individual products with variable information. It is not clear if the MoHFW guidelines stipulating use of a generic “Bar Code” is meant to also include DataMatrix codes. It is recommended that future revisions of the draft remove any mention of QR codes, and instead specifically identify DataMatrix as the data carrier of choice. This amendment would remove any ambiguity and allow harmonization with international standards.

The bigger problem is that the MoHFW draft does not provide guidance on exactly how the different data fields are to be embedded in the barcode, and by what rules. Imagine that all fields are integrated into a continuous string. But then, how will any future reader, human or machine, make any sense of that concatenated string? How will the boundaries between the different data strings be delineated to make sense of what information belongs to what field, such as batch number, expiry date, etc.? Simply put, the lack of a parsing format will produce utter chaos.

The Indian barcoding mandate must be aligned with global standards

Many international programmes have solved the data-parsing problem by adopting rules developed by GS1, an international organization that issues standards for product identification and barcode data content [2]. Each data field in the GS1 schema is preceded by a so-called application identifier (AI) that defines the nature of the ensuing content. Machine reading then allows the different fields in the barcode to be parsed and presented in the context of their original meaning as defined by the AIs.

The published MoHFW draft contains neither mention of a data parsing methodology nor reliance on global standards developed by GS1. It is now imperative for the Indian programme to draw upon and incorporate standardized protocols that have been successfully implemented elsewhere and shown to be effective. GS1 has also developed an efficient format for product identification via the so-called Global Trade Item Number (GTIN), which neatly merges country, company, and SKU identities into a 14-digit numeric string that can be publicly accessed through searchable databases.  

It is recommended that future amendments to the Indian guidelines incorporate use of GS1 standards for barcoding (DataMatrix), product identity (GTIN), and formatting rules for embedded data fields (AIs).  

Variable barcode printing on most primary packages will create a dilemma for manufacturers

Once the barcoding content and parsing protocol have been clearly defined, it will then be necessary to print or affix the barcode onto drug packages. The MoHFW draft states that the barcode will be placed on “primary packaging label, or, in case of inadequate space in primary package label, on the secondary package label …”. This declaration is vague and opens up a host of future problems.

A primary drug package in India is one that comes into contact with the medicine, and which may not necessarily be the saleable pack. This distinction is important. Some blister packs are sold directly as such and others are placed inside a monocarton, which by definition is the secondary pack. In both scenarios, the blister is the primary even when the saleable is a monocarton. The same consideration applies to bottles and vials. Although in most international programmes the saleable pack is the starting point for barcoding, the same will not hold true in India. And this fact has some important consequences.

It is well known that printing of barcodes directly on blister foil at the packaging line is extremely difficult. Although batch number and expiry date can be placed with dot-matrix printers that use solvent inks, any effort to print a DataMatrix barcode will render it unreadable due to poor resolution. Water-based inks that are used for printing high-resolution barcodes on porous surfaces, such as cartons, cannot be used on aluminium foil due to ink adherence problems. Consequently, there are few options for placing variable barcodes directly on blister foil, except by affixing a printed label.

A label print-and-apply approach on blisters would however represent a costly solution and likely not be affordable to many manufacturers, especially as the programme grows to encompass lower-cost medicines. The MoHFW draft however provides an interesting loophole to manufacturers as a way out of this dilemma — that in the event there is little space on the primary package, the barcode can be applied on the secondary. And that in turn leads to an entirely different problem.

A small loophole in the draft guidelines will render the programme (largely) ineffective

The workaround described above for barcoding the secondary pack would be effective in the case of monocartons containing a single blister, bottle, or vial. After all, this would be no different than the practice in most other countries. The problem that arises with this solution in India is that the secondary package for the vast majority of blister-packed medicines is actually a polycarton — a package that contains several blisters and which really serves as a means for product delivery to retailers instead of sale to a customer.

After delivery, retailers discard the polycartons and sell the encased blisters individually. Barcoding a polycarton, by definition also a secondary pack, through use of the loophole will not serve the core objective of protecting consumers against counterfeiting because of the multiple ways a blister can make its way to the retail point. And since barcoding of blisters can be bypassed in this programme through the loophole, counterfeiters would have an open path to their trade without the hindrance of replicating any required authentication features placed on original products.

The key takeaway from the above analysis is that an effective anti-counterfeiting programme must encompass all saleable medicine packages, irrespective of how they are defined, including blister and alu-strip packages. The MoHFW draft fails to clearly state that requirement and therefore the counterfeit trade on blisters can be expected to continue and even flourish if enacted.

There is a solution to this dilemma, however, that includes deploying a serialization regime as part of an integrated and robust consumer protection programme. But therein lies another complication, as taken up next.

There is no requirement for serialization in the draft guidelines

The MoHFW draft guidelines do not contain a requirement for serialization — i.e., unique identification at the individual package level. The closest requirement is for a “unique product identification code”, which is a brand- or SKU-level identifier such as GTIN or another digital descriptor. Serialization, on the other hand, requires that each medicine package across the board, even from the same SKU, be bestowed with its own unique digital identity. And that unique identifier must be incorporated into the barcode and also printed in human-readable form.

It is not clear if the absence of a serialization requirement was an oversight in the MoHFW draft. That is likely the case because one of the identified objectives of the programme is to use barcode data with a software application to “facilitate authentication”, and perhaps even supply chain traceability down the road. Those objectives cannot be met in the current draft framework because package-level identity is missing. There is no point in incorporating product-level data into a barcode without the additional ability to identify and authenticate the actual drug package itself. Even amateur counterfeiters could place a parallel non-serialized barcode on their packages and continue their trade with impunity.

We now know enough about developing effective anti-counterfeiting programmes and implementing best practices for market surveillance. That is a large topic and therefore deserves its own dedicated treatment in the next report.

Summary

The foregoing sections of this article covered data content and effective protocols for barcode integration using global standards. The printing of barcodes on medicine packages and the dilemma this can present to manufacturers was also explored. We have therefore discussed what data should be in the barcode, how it should be encoded, and where the barcode should be placed? And finally, there was discussion of a loophole in the draft guidelines that can present substantial jeopardy and render the programme ineffective for most blister packages, where counterfeiting is especially rampant.

Although the technical issues taken up here are largely in the domain of solution specialists, it is undeniable that inadequate attention to such key details by regulators at the outset can later derail an otherwise visionary programme. These foundational issues are actually critical to programme success because they represent the doorway to all future authentication activities — by manufacturers, supply chain participants, regulators, and even marketplace stakeholders such as consumers.

The next report in this three-part series will discuss how a sound and economical programme design specific to the Indian context can create truly effective anti-counterfeiting outcomes and forge an enduring legacy in protecting Indian consumers.

References

[1]    https://medicaldialogues.in/pdf_upload/qr-code-178763.pdf

[2]    https://www.gs1india.org

Dr Avi Chaudhuri is founder of The Kulinda Consortium, a global alliance of solution providers that focuses on emerging nations to protect their citizens from counterfeiting, illicit trade, and revenue loss. His work in this field began when he became the victim of a counterfeit drug while traveling in India nearly two decades ago.

Dr Chaudhuri introduced the very concept of serialization to the Indian pharmaceutical industry in 2007, which later set in motion India’s drug export serialization programme. He is an acclaimed expert in the field of anti-counterfeiting, working with both governments and the private sector.