Manish Garg of Hikma Pharmaceuticals

The United States pharmaceutical supply chain is increasingly reliant on complex global networks of suppliers and providers for API, semi-finished and finished drugs, and Medical Devices and Equipment, exposing it to significant vulnerabilities such as counterfeit drugs, tampering, and logistical inefficiencies, which leads to Risk to Patient trust, safety, and drug delivery delays. The Drug Supply Chain Security Act (DSCSA, enacted in 2013), which mandates an interoperable, electronic track-and-trace system, necessitates advanced technological solutions to ensure end-to-end traceability and bolster public health security. This abstract outlines how emerging technologies, including advanced manufacturing, RFID/ NFC/electronic labels, blockchain, and Artificial Intelligence (AI), can be integrated to secure pharmaceutical production and establish a transparent, resilient supply chain that ensures robust DSCSA compliance and benefits Americans.

Biography:

Manish Garg is a Senior IT Leader at Hikma Pharmaceuticals, where he leads Serialization, Track and Trace initiatives globally, which interface with Manufacturing and Supply chain of pharmaceutical drugs. With over 20 years of experience spanning IT innovations and digital transformation in high-tech manufacturing companies, HP and Apple to global Biotech and pharmaceutical companies. At Hikma, Manish leads critical projects to ensure compliance with regulations such as the U.S. Drug Supply Chain Security Act (DSCSA), EU FMD, and Saudi Arabia, UAE, Bahrain in the Middle East. His expertise also significantly contributes to new markets, new product launches, Technology Transfer, and external supply chain integration. Manish is an active contributor to industry groups like IEEE, GS1, PDG, the FDA, and SAP Co-Innovation engagements.