Pharmaceutical companies have to contend with challenges stemming from supply chain security lapses (testing in theft, diversion and product recalls), counterfeiting and stringent regulations. In addition to alarming safety concerns, these challenges also impair the health of the industry by adversely impacting profits, brand credibility and research initiatives.
With both industry and governments around the world realising the significance of implementing product serialization, it becomes mandatory for all entities within the supply chain to comply with federal and/or state regulations pertaining to the locations in which they operate.
Typically, drug distribution systems consist of entities such as manufacturers, wholesale distributors and pharmacies before products reach the end consumer. Ensuring secure product trace and trace capabilities across various touch points throughout the supply chain—through product sterilization implementation—is crucial to address the challenges faced by the industry. Apart from providing visibility and full traceability within the supply chain, successful serialization programs will prove to be a key differentiator and a clear competitive advantage for pharmaceutical companies.
This guide, compiled by the Legal and Research team at the Infosys Life Sciences Centre of Excellence provides a summary of the legal and regulatory framework proposed by countries including Argentina, Brazil, China, EU, France, India, South Korea, Turkey and USA (Federal and California) to maintain supply chain integrity and ensure patient safety. This guide also provides information on mandates to be adhered to by various stakeholders, to ensure regulatory compliance.