REGULATORY REQUIREMENTS FOR BLOCKCHAIN TECHNOLOGY FOR ENSURING DRUG TRACEABILITY AND COMPLIANCE IN THE INDIAN PHARMACEUTICAL SUPPLY CHAIN IN COMPARISON WITH USA

Dr. Ashok Kumar P., Harshitha Y. G., Godavari C. S., Bhavana, Ankita Malatesh Madivalar, Aishwarya

ABSTRACT

The pharmaceutical industry faces unprecedented challenges in ensuring drug authenticity, maintaining supply chain integrity, and achieving regulatory compliance across global markets. This research examines the transformative potential of blockchain technology in addressing these critical issues within the Indian and USA pharmaceutical supply chains. Through a comprehensive analysis of current implementations, regulatory frameworks, and case studies, this study demonstrates how blockchain's core principles of immutability, transparency, and decentralization create an unbreakable chain of trust throughout pharmaceutical distribution networks. The research reveals that counterfeit drugs represent a $4.4 billion global market[1], with approximately 10.5% of drugs in low- and middle-income countries being fake or substandard2. In response, both India and the USA have implemented significant regulatory amendments and blockchain pilot programs. The study analyses major initiatives including MediLedger, BRUINchain, and India's Drug Authentication and Verification Application (DAVA), demonstrating how blockchain technology can achieve up to 99.9% recall efficiency and generate substantial economic benefits including $1 billion in increased revenue through improved patient outcomes.[3] The findings indicate that blockchain implementation can reduce counterfeit drug incidents by up to 30%[4], streamline regulatory compliance, and enhance stakeholder collaboration. This research provides critical insights for policymakers, pharmaceutical companies, and technology developers seeking to implement blockchain solutions for drug traceability and compliance in complex global supply chains.

Keywords: Blockchain, Mediledger, DAVA, BRUNchain, India.