Title:Steering through Regulatory Currents: The Journey of India’s Pharma Industry with the USFDA
Volume: 10
Author(s): Raj Kamal, Diksha, Priyanka Paul and Ankit Awasthi*
Affiliation:
- Department of Pharmaceutics, ISF College of Pharmacy,
Moga, 142001, Punjab, India
Keywords:
USFDA, non-compliance, warning letters, cGMP, automation, AI.
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.
