Steering through Regulatory Currents: The Journey of India’s Pharma Industry with the USFDA

Raj      Kamal; Diksha; Priyanka      Paul; Ankit      Awasthi

doi:10.2174/0126673371310378240808054710

Abstract

Introduction and Objective: India's pharmaceutical industry faces challenges in meeting USFDA quality standards, impacting exports and reputation. This review examines the causes of non-compliance and proposes strategies to enhance compliance, predicting future trends.

Methods: This study conducts an analysis of USFDA warning letters to Indian manufacturers, an assessment of non-compliance issues, and an exploration of technological advancements in compliance, such as automation and AI.

Results: The study reveals a rise in non-compliance incidents, emphasizing the need for a robust quality culture, updated regulatory knowledge, and implementation of advanced technologies to improve compliance.

Conclusion: To maintain global competitiveness, India's pharma industry must adopt comprehensive strategies, leverage technology, and prepare proactively for regulatory changes. Future compliance will rely on remote auditing and real-time monitoring.

Keywords: USFDA, non-compliance, warning letters, cGMP, automation, AI.

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DOI https://dx.doi.org/10.2174/0126673371310378240808054710	Print ISSN 2667-3371
Publisher Name Bentham Science Publisher	Online ISSN 2667-338X

Applied Drug Research, Clinical Trials and Regulatory Affairs

Steering through Regulatory Currents: The Journey of India’s Pharma Industry with the USFDA

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