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Abstract
Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines represent a global standard for Good Manufacturing Practices (GMP), aimed at harmonizing inspection procedures and ensuring the quality, safety, and efficacy of pharmaceutical products. For Indian pharmaceutical companies, which play a pivotal role in the global supply chain, aligning with PIC/S regulations is critical yet fraught with multiple challenges. This article examines the multifaceted obstacles faced by Indian pharma firms in achieving PIC/S compliance, such as infrastructural gaps, regulatory misalignment, workforce skill deficits, and financial constraints. The paper also explores policy-level interventions and strategic solutions to bridge these gaps and enhance India's position in the global pharmaceutical regulatory landscape.