2025-02-20

Q: What compliance measures should pharmaceutical companies adopt to meet WHO's guidelines on counterfeit drugs and how is ASPA helping in educating pharmaceutical companies on the latest authentication technologies?

The pharmaceutical industry is adopting multiple approaches to align with WHO guidelines in combating counterfeit drugs. A structured three-pronged strategy could be the way forward—prevention through strong quality management systems, detection using advanced authentication technologies, and rapid response protocols for handling incidents. Companies should focus on strengthening supply chain controls and integrating Physical, Digital and Phygital anti-counterfeiting technologies like holograms, tamper-evident labels, RFID tracking, and machine-readable covert markers, which provide multiple layers of security, blockchain-based track-and-trace systems, smartphone-based authentication using QR codes, and AI-powered verification tools for product verification. 

Industry association like ASPA play a key role in supporting this effort. They help companies understand and implement authentication solutions through seminars, webinars, and stakeholder discussions. Their public repository on counterfeit product raids provides useful insights into counterfeiting patterns and prevention strategies. The ASPA & CRISIL Report 2022 also highlights challenges in tier II/III cities and rural areas, offering data-driven guidance for companies to refine their authentication measures. 

Looking ahead, industry collaboration is critical. The 6th edition of Traceability & Authentication Forum 2025, happening on March 17–18 in New Delhi, will bring together policymakers, brands, and industry leaders to discuss advancements in traceability and authentication. This platform will help stakeholders navigate regulatory changes and strengthen supply chains against counterfeiting threats.

Q: Mention some of the key challenges that exist in implementing QR code-based authentication systems for pharmaceuticals?

Implementing QR code-based authentication in pharmaceuticals comes with several operational and security challenges. One major issue is ensuring consistent print quality across different packaging materials. If QR codes are not printed clearly, scanning failures can occur, disrupt authentication and potentially affecting patient safety. Given the high stakes in pharmaceuticals, reliable verification is critical. 

Another challenge is data management. Companies need to generate and store millions of unique QR codes securely while preventing duplication or corruption. Managing serialization data across a global supply chain adds complexity, requiring strong data infrastructure and cybersecurity measures. Additionally, integrating QR code systems with high-speed production lines is not straightforward. Printing must be precise, and the process must synchronize seamlessly with production without slowing down operations. 

Legacy manufacturing equipment can also be a limitation. Older systems may struggle with QR code printing, leading to smudging, misalignment, or scanning errors. Upgrading to advanced printing and verification technologies involves significant investment. Beyond printing, real-time scanning and verification across the supply chain remain a challenge, as consistent implementation at every stage requires coordination and robust systems. 

Addressing these issues demands investment in better printing technologies, stronger data management systems, and thorough staff training. These complexities highlight the need for industry-wide discussions on platforms like Traceability & Authentication Forum, that bring together stakeholders to share insights, explore solutions, and navigate evolving regulatory and technological landscapes.

Q: What is the role of third-party certification in pharmaceutical authentication technologies?

Third-party certification acts as a critical watchdog in the complex world of pharmaceutical authentication, where the stakes of ensuring genuine medications reach patients couldn't be higher. Interestingly, while consumer fears about counterfeit drugs run high at around 20% of the market, as per a consumer survey conducted across 12 key cities, mentioned further in the ASPA-CRISIL Report 2022, the actual reported cases by CDSCO are much lower at 0.046% - highlighting why independent verification is so important for both safety and public confidence.

Think about it this way: when pharmaceutical companies implement authentication technologies like QR codes, security labels, or tamper-evident packaging, someone needs to verify these systems work as intended. This is where third-party certifiers step in, providing an unbiased eye to validate everything from the basic functionality to compliance with complex regulations.

The role of these certifiers extends beyond just a one-time check. They conduct ongoing audits, testing, and monitoring to ensure authentication systems stay effective against ever-evolving counterfeiting threats. This is particularly crucial when you consider that a third of consumers who bought counterfeit drugs didn't even realize they were fake at the time of purchase.

What makes third-party certification especially valuable is its independence. When a certifier validates a company's authentication technology, it creates a circle of trust between manufacturers, regulators, and consumers. They're essentially saying, "We've checked this system thoroughly, and it meets all the necessary standards for keeping medications safe and traceable." This independent validation becomes a cornerstone of pharmaceutical security and public health protection.

Q: What are the security implications of implementing digital authentication tools in supply chains?

Implementing digital authentication tools in pharmaceutical supply chains introduces both security benefits and new vulnerabilities that need careful management. Technologies like QR codes, track-and-trace systems, RFID tags, and blockchain-based serialization help in combating counterfeiting, but they also create multiple digital touchpoints that cybercriminals can exploit. With Drugs (Amendment) Rules, 2022 mandating such systems, companies must ensure these authentication technologies do not become weak points in their supply chain.

The interconnected nature of modern supply chains means security cannot be limited to a single company—it must extend to third-party vendors and logistics providers. Cybercriminals often exploit the weakest link, which is why companies like Roche have adopted encryption software for consumer verification. This highlights the importance of building security into authentication systems from the start rather than as an afterthought.

To mitigate these risks, companies must adopt encrypted data transmission, multi-factor authentication, and regular security audits. Vetting technology providers and defining strict protocols for data sharing are also critical. Striking the right balance between security and usability is key, especially when 33% of consumers, as per the ASPA & CRISIL report of 2022, unknowingly purchase counterfeit pharmaceuticals. Industry platforms discussing authentication and cybersecurity help stakeholders navigate these challenges and develop more secure supply chains.

Q: What innovative authentication solutions is ASPA working on to combat fake medicines globally?

ASPA members are actively working on multi-layered authentication solutions to combat counterfeit medicines globally. Given the increasing sophistication of counterfeiters, ASPA’s member companies are developing integrated security technologies that combine overt, covert, forensic, and digital authentication methods to ensure product authenticity at every stage of the supply chain.

These solutions include secure holograms, tamper-evident labels, RFID tracking, and machine-readable covert markers, which provide multiple layers of security. Digital technologies such as blockchain-based track-and-trace systems, smartphone-based authentication using QR codes, and AI-powered verification tools are also being deployed. These not only help in real-time product verification but also allow authorities and consumers to track medicines from manufacturing to the point of sale.

ASPA promotes ISO 22383 authentication frameworks, ensuring companies adopt the best mix of technologies suited to their specific challenges. Additionally, ASPA facilitates collaboration between industry stakeholders, regulators, and technology providers through knowledge-sharing platforms like the 6th Traceability and Authentication Forum 2025. This event will focus on next-generation authentication solutions, further strengthening the fight against counterfeit pharmaceuticals globally. By continuously innovating and advocating for stronger authentication frameworks, ASPA is helping secure the pharmaceutical supply chain and protect consumer health.  ASPA Invites Industry stakeholders to add their valuable presence and be a part of this Insightful discussion.