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Having implemented several key regulatory measures to combat counterfeit pharmaceuticals in the last few years, the government should now look at additional regulatory and policy developments including potential expansion of mandatory serialisation and strengthening of enforcement mechanisms to fight the menace of counterfeiting, says an expert in the field.
The Government of India has in January, 2022, mandated inclusion of quick response (QR) codes on the labels of all active pharmaceutical ingredients (APIs) for end-to-end tracking and tracing, and amended the Drugs Rules effective from August 1, 2023, stipulating that 300 drug formulations under Schedule H2 to incorporate a barcode or QR code on the primary packaging, and in some cases, the secondary packaging.
Taking these steps into consideration, Manoj Kochar, president of Authentication Solution Providers' Association (ASPA) said, "Looking ahead, ASPA anticipates additional regulatory and policy developments, including the potential expansion of mandatory serialization across all pharmaceutical categories, increased adoption of blockchain technology for transparent data sharing, and the strengthening of enforcement mechanisms."
"Ongoing collaboration among industry associations, regulators, and technology providers will be critical to advancing these initiatives. ASPA remains committed to supporting these efforts by offering technical expertise and facilitating multi-stakeholder engagement," he added in an email interaction with Pharmabiz.
The Association envisions a future where anti-counterfeiting measures are not only implemented but deeply embedded throughout India’s pharmaceutical supply chain, he averred.
This future will be characterized by greater scale, intelligence, and regulatory coordination. While secure QR codes, blockchain, RFID/NFC tags, and holograms are already in use, the next phase will focus on mass adoption, system-wide integration, and interoperability among stakeholders.
"We anticipate a shift from fragmented solutions to a unified, nationwide traceability framework that allows real-time product authentication from manufacturer to consumer," said Kochar.
Innovations in data analytics and AI will further enable predictive risk monitoring and rapid identification of counterfeit hotspots. Serialization and tamper-evident packaging will evolve from mere compliance requirements to active enablers of patient safety.
The Association will be driving this transformation by fostering collaboration among the government, pharmaceutical companies, and technology providers. Through continuous innovation, standardization, and public engagement, ASPA aims to build a pharmaceutical ecosystem where counterfeit medicines are not just detected but actively deterred and prevented, he said.
From ASPA’s perspective, the sector presents opportunities such as expanding adoption of QR code-based authentication, serialization, and traceability tools, which can substantially improve supply chain transparency.
However, there are challenges such as achieving consistent print quality across diverse packaging materials, integrating new systems with legacy manufacturing infrastructure, and securely managing large volumes of serialization data.
Moreover, aligning all stakeholders in the supply chain and enabling real-time product verification continues to be difficult. The Association is addressing these challenges by promoting dialogue, sharing best practices, and accelerating the implementation of anti-counterfeiting technologies through platforms such as the Traceability & Authentication Forum.
The Forum met this year, bringing together industry leaders, government officials, and technology providers to discuss emerging threats, policy developments, and technology-driven responses.
ASPA also runs consumer awareness campaigns that promote product verification and informed purchasing decisions. Through its public repository of counterfeit product seizures and the ASPA–CRISIL Anti-Counterfeiting Report, ASPA provides actionable intelligence and trend analysis, said Kochar.
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