Improvement in Indian Drug Manufacturing Facilities' USFDA Inspections Signals Strong Compliance Gro

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Improvement in Indian Drug Manufacturing Facilities' USFDA Inspections Signals Strong Compliance Gro

Team Finance Saathi

28/Jun/2024

Key Points:

Indian drug manufacturing facilities improved USFDA inspection outcomes in 2023, with only 13% classified as Official Action Indications (OAIs), below the global average of 15%.
This marks a significant decline from 26% OAIs observed in 2014, showcasing enhanced adherence to CGMP and regulatory standards.
McKinsey & Company highlights ongoing industry efforts and areas for improvement, emphasizing infrastructure enhancements and quality management practices.

In 2023, Indian drug manufacturing facilities exporting to the United States showcased remarkable progress in regulatory compliance, according to reports from the Indian Pharmaceutical Alliance and McKinsey & Company. The United States Food and Drug Administration (USFDA) conducted 145 inspections, classifying only 13% of these facilities as Official Action Indications (OAIs). This figure is notably lower than the global average of 15% OAIs, indicating significant strides in adhering to current good manufacturing practices (CGMP) and regulatory standards.

The decline in OAIs from 26% observed in 2014 underscores the industry's commitment to enhancing operational excellence and quality control measures. An OAI classification from the USFDA signifies areas of non-compliance that, if unresolved, could lead to regulatory actions such as warning letters or import bans. While OAIs typically do not halt ongoing operations directly, they can impede new product approvals and necessitate increased investment in remediation efforts.

The inspections also shed light on areas for improvement within the Indian pharmaceutical sector, including the need for enhanced CGMP training, strengthened laboratory controls, and refinements in core manufacturing processes. McKinsey & Company's senior partner, Mr. Sathya Prathipati, highlighted ongoing efforts within the industry to meet evolving regulatory expectations. He noted significant improvements in facility infrastructure and the implementation of robust root cause analysis frameworks, crucial for sustaining compliance and operational efficiency.

Overall, the findings illustrate a positive trend towards improved regulatory compliance and operational standards among Indian drug manufacturers exporting to the US market. This progress not only bolsters the reputation of Indian pharmaceutical products globally but also reinforces the industry's commitment to delivering high-quality, compliant medications that meet stringent international standards.

Also Read : RBI's 29th Financial Stability Report Reveals Strong Performance and Resilience of Indian Banks

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Improvement in Indian Drug Manufacturing Facilities' USFDA Inspections Signals Strong Compliance Gro

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