Indian pharma improves compliance with USFDA; fewer OAI cases in 2024

Recent USFDA data reveals a decline in the number of adverse classification outcomes of inspections

Indian pharmaceutical companies have made major strides in adhering to stringent US Food and Drug Administration (USFDA) norms in 2024, with data suggesting a decline in the number of adverse classification outcomes of inspections across biologics, drugs, and devices.

 

In 2023, the USFDA conducted 225 inspections, which led to 18 cases of Official Action Indicated (OAI) and 117 cases of Voluntary Action Indicated (VAI). By 2024, despite a tightening of regulatory standards, the number of inspections dropped to 206, while OAI cases fell to 14 and VAI cases reduced to 115. This highlights that the sector is increasingly aligning with global benchmarks to ensure high-quality manufacturing practices.

 

 

Looking back at the pre-pandemic years, there was a 100 per cent increase in OAI status from 2018 to 2019. However, the onset of the pandemic in 2020 led to a 75 per cent drop, and the status fell 50 per cent in 2021.

 

When the FDA inspects a facility, it classifies the results based on the findings of the inspection. In case of any deficiency, the facility receives a VAI classification, which signifies that objectionable conditions or practices were observed, but the facility is given the opportunity to correct them voluntarily without immediate regulatory action from the FDA. The FDA may facilitate this process through a regulatory meeting.

 

On the other hand, an OAI classification indicates serious regulatory violations that significantly impact safety, welfare, or data reliability. In such cases, the FDA recommends administrative or regulatory actions, which may include warning letters, untitled letters, or even legal actions like import alerts or injunctions. If no violations are found during an inspection, it is classified as No Action Indicated (NAI). The FDA typically communicates the final inspection classification to the firm within 45 to 90 days after the inspection is completed. 

 

The Indian Pharmaceutical Alliance (IPA) attributed this improvement to a multi-faceted approach emphasising quality culture, operational enhancements, and proactive compliance measures.

 

IPA Secretary General Sudarshan Jain highlighted the industry’s efforts in creating a robust quality framework. “Indian pharma companies have undertaken substantial work in fostering a culture that prioritises quality. The senior leadership teams are committed to continually improving standards, supported by automation, robust Standard Operating Procedures (SOPs), and ongoing employee training,” Jain said.

 

According to Jain, the senior leadership has prioritised embedding a quality-first mindset across organisations, building a culture focused on excellence. Advanced automation technologies have been implemented in manufacturing plants to enhance precision and efficiency.

 

Comprehensive SOPs have been established and rigorously followed to ensure consistency in operations. Employee training programmes have been accelerated to build capabilities and align with global standards, complemented by capability-building programs that emphasise skill enhancement and process standardisation. Also, there is a commitment to process improvements aimed at achieving operational excellence.

 

The IPA said it remains committed to further upgrading quality standards. “This progress underscores our commitment to taking quality standards in India forward. We view this as part of a continuous effort to strengthen the quality culture and align with global benchmarks,” Jain said.