Pharmaceutical medicine traceability: An overview of global compliance
Serialization consultant, HCL Tech, Hyderabad, India.
Review
World Journal of Biology Pharmacy and Health Sciences, 2023, 15(02), 245–252.
Article DOI: 10.30574/wjbphs.2023.15.2.0358
Publication history:
Received on 03 July 2023; revised on 20 August 2023; accepted on 23 August 2023
Abstract:
Every human being has a fundamental right to access to healthcare. It is the duty of the government to provide its citizens with high-quality infrastructure and healthcare services. Government agencies and the healthcare sector have been working to reduce the negative effects that bogus drugs have on people's health for the past few decades. According to the World Health Organization, 4 out of 10 medicines in emerging and underdeveloped nations are either fraudulent or may be contaminated. The international economy suffers from counterfeit drug costs in the billions of dollars, and organizations are forced to spend less on research and development (R&D). The biggest difficulty facing the government and regulatory agencies is preventing the entry of fake medications into the supply chain. The government and regulatory bodies are currently creating strict regulations to forbid criminals and medicine counterfeiters from selling phony drugs in markets. To offer patients with safe and effective medications, the healthcare business needs strict laws and secure systems. The FDA has released a 10-year implementation roadmap for drug traceability in the US. The Healthcare Distribution Alliance (HDA) has additionally specified that the product packaging hierarchy print multiple barcodes and human readable data. The FDA is taking part in a pilot initiative with major prescription medicine producers and wholesalers to deploy blockchain technology in an open-source, interoperable digital network for ensuring the transfer of digital traceability data between licensed business partners.
Keywords:
Drug Traceability; Drug Counterfeit; Pharmaceutical Serialization; Regulatory Compliance; Supply chain; Blockchain; Developing Countries
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Copyright © 2023 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0