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

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.

Cite this article as:

Kamal Raj, Diksha , Paul Priyanka and Awasthi Ankit*, Steering through Regulatory Currents: The Journey of India’s Pharma Industry with the USFDA, Applied Drug Research, Clinical Trials and Regulatory Affairs 2024; 10 : e26673371310378 . https://dx.doi.org/10.2174/0126673371310378240808054710