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2000
Volume 10, Issue 1
  • ISSN: 2667-3371
  • E-ISSN: 2667-338X

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.

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/content/journals/adctra/10.2174/0126673371310378240808054710
2024-09-19
2025-01-19
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  • Article Type:
    Review Article
Keyword(s): AI; automation; cGMP; non-compliance; USFDA; warning letters
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