Full text loading...
-
Steering through Regulatory Currents: The Journey of India’s Pharma Industry with the USFDA
- Source: Applied Drug Research, Clinical Trials and Regulatory Affairs, Volume 10, Issue 1, Jan 2024, E26673371310378
-
- 13 Mar 2024
- 05 Jul 2024
- 19 Sep 2024
Abstract
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.
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.
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.
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.