1Department of Pharma Regulatory Affairs, K.B. Institute of Pharmaceutical Education and Research (KBIPER), a constituent college of Kadi Sarva Vishwavidyalaya (KSV), Sector-23, Gandhinagar-382024, Gujarat, India.
2Makcur Laboratories pvt. ltd, Near Sola Bridge, SG Highway, Thaltej, Ahmedabad - 380054. Gujarat. India.
*Corresponding author. E-mail address: niranjan.kanaki@kbiper.ac.in (N Kanaki)
False and counterfeit drugs are a significant worldwide medical danger especially in low and middle incomes where up to 1 out of 10 Medicines can be of inferior quality. Drug safety is also becoming hard to ensure through increased globalization and complexity of supply chains. Laws such as EU-FMD or US-DSCSA help to solve such problems by implementing the system of serialization, verifying, and tracing. At the same time, the centralized verification clarifies the concept of FMD, whereas DSCSA dwells upon end-to-end track-and-trace mechanisms. All these structures contribute to transparency and allow avoiding false medicines penetrating into the supply chain.
EU-FMD and US-DSCSA offer huge improvements in the supply chain security of the pharmaceutical; this is achieved by serialization, traceability, and verification systems. Even though their methods are not the same, both frameworks are successful in ensuring a decrease in the chances of falsified medicines. Ongoing technology innovation and harmonization of regulations across the globe are indispensable towards improvement in the future.
Pharmaceutical supply chain, Falsified medicines, Drug Supply Chain Security Act, Falsified Medicines Directive, Track and trace, Serialization, Regulatory compliance
