Beyond Compliance: Rethinking Drug Safety and Traceability in 2026
Compliance has long been treated as the destination. In 2026, the industry is beginning to understand it is only the starting line.
Our co-founder Abiram Vijayakumar, and Dr. Avi Chaudhuri, Former Chief Scientist at Systech and Founder of The Kulinda Consortium, sat down to explore what it truly means to build drug traceability systems that protect patients and brands, not just satisfy auditors.
The result is an industry opinion paper that asks the questions most Pharma Supply Chain, IT and Packaging leaders avoid.
a. The QR Code Paradox
India’s QR coding mandate was designed to protect consumers. In practice, it created what Dr. Chaudhuri calls an “anatomy of a debacle.”
The mandate had two critical loopholes — a space loophole that allowed QR codes to be placed on secondary packaging never seen by consumers, and the absence of unit-level serial numbers that made effective authentication impossible. The outcome? Counterfeit medicines now falsely reassure consumers that they are genuine.
This is what happens when compliance becomes the finish line.
b. Authentication vs. Traceability
One of the sharpest distinctions in the paper is the difference between track and trace and drug authentication. These are not the same thing, and they cannot be solved by the same approach.
Track and trace tells you where a product has been. Authentication tells you whether the product in a consumer’s hand is genuine. Both matter. Neither is sufficient alone.
c. Consumer as the Final Line of Defense
Even the most technically sound authentication program will fail without consumer adoption. Dr. Chaudhuri’s perspective is clear: technology cannot convince a consumer to use it. That requires public awareness, simplicity, and trust earned through consistency.
d. Data Ownership, Vendor Lock-In, and Technology Choices
The paper also tackles a harder conversation: what separates technology investments in pharma that hold up over time from those that become liabilities?
The answer isn’t the feature set at the point of purchase. It’s whether the company retains control of its data and its choices. Systems built on proprietary formats, or designed to make data difficult to access, create a dependency that compounds over time. Switching becomes a business risk in itself, which is exactly how some vendors want it.
At AltiusHub, our position is straightforward. Your data belongs to you. The system should make that easy to exercise, not harder.
e. What Meaningful Progress Looks Like
Five to seven years from now, meaningful progress in drug traceability won’t be defined by new mandates or more complex programs. It will be defined by how much harder it becomes for counterfeits to enter the supply chain.
Read the Full Paper
This blog captures only a portion of the conversation. The full opinion paper goes deeper into regulatory frameworks, the role of AI, the Indian pharma landscape and what a genuinely future-ready traceability ecosystem looks like.
.webp)
Frequently asked questions
Traceability tracks a product’s movement across the supply chain, while authentication verifies whether the product itself is genuine. A system can track perfectly and still fail to confirm authenticity, leaving gaps for counterfeit medicines to enter the supply chain unnoticed.
Compliance defines minimum standards, not real-world protection. Many traceability systems meet regulatory requirements but fail to address evolving counterfeit risks. This creates a false sense of security without ensuring actual patient safety or long-term brand protection.
Serialization enables tracking but does not prevent duplication or misuse of unique identifiers. Counterfeiters exploit gaps in verification, data silos, and system interoperability, allowing fake products to enter supply chains even when traceability systems are in place.
Major gaps include overreliance on compliance-led systems, lack of unit-level authentication, fragmented data across partners, and limited interoperability. Many systems are built for audit readiness, not for detecting or preventing real-world counterfeit risks.
As systems mature, the focus is shifting from implementation to outcomes. Pharma leaders are questioning whether existing traceability infrastructure truly protects patients and brands, especially as supply chains grow complex and counterfeit methods become more sophisticated.
Meanwhile, read our top resources
