Pharmaceutical sector: Packaging requirement in serialization

Naveen Sharma *

Noida, New Delhi, India.
 
Review
International Journal of Science and Research Archive, 2024, 11(02), 1719–1725.
Article DOI: 10.30574/ijsra.2024.11.2.0632
 
Publication history: 
Received on 29 February 2024; revised on 17 April 2024; accepted on 20 April 2024
 
Abstract: 
Access to healthcare is a fundamental right for every individual, and it is the responsibility of governments to ensure the provision of quality healthcare services and infrastructure to their citizens. Over the past few decades, both governments and the healthcare industry have been grappling with the challenge of minimizing the adverse effects on public health caused by counterfeit medicines. According to the World Health Organization, approximately four out of ten medicines in developing and impoverished countries are either fake or potentially adulterated, leading to significant economic losses and reducing funds allocated for research and development (R&D) by organizations. Preventing counterfeit medicines from entering the supply chain poses a significant challenge for governments and regulatory authorities. Consequently, there is a concerted effort to establish stringent guidelines aimed at thwarting criminals and counterfeiters from infiltrating markets with fake medications. The healthcare industry recognizes the necessity for strict regulations and secure technologies to ensure the provision of safe and authentic drugs to patients.  In the United States, the FDA has outlined a ten-year roadmap to implement drug traceability measures. Additionally, the Healthcare Distribution Alliance (HDA) has mandated the inclusion of multiple barcodes and human-readable data in product packaging hierarchy. Furthermore, the FDA is actively engaged in a pilot project with leading pharmaceutical manufacturers and wholesalers to explore the utilization of blockchain technology within an interoperable digital network for securing the transfer of digital traceability data among authorized trading partners.
 
Keywords: 
Drug Traceability; Pharmaceutical Serialization; Track and Trace System; Healthcare supply chain; GS1 Barcode.
 
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