Indian pharma sector's regulatory violation instances fell 11% in '24

From 23 per cent in 2014, the share of regulatory violation instances which entail Official Action Indicated (OAI) tag by the US’ drug regulator sharply dropped to 11 per cent in 2024, suggesting that Indian pharmaceutical industry has jacked up its compliance with the international standards in the face of more stringent norms.

 

The global average of 14 per cent is also much higher than the India’s 11 per cent even . The total number of USFDA inspections has declined globally, from around 1,849 annually in 2014 to approximately 940 in 2024, while India’s share has surged, the Indian Pharmaceutical Alliance (IPA) said.

 

In 2014, the share of OAI status globally stood at 6 per cent which has now more than doubled standing at 14 per cent.

 

In 2014, only 6 per cent of global inspections were conducted in India. This figure has now tripled to 18 per cent, highlighting the country’s growing role in the global pharmaceutical supply chain.

 

The USFDA classifies inspection outcomes into three categories: No Action Indicated (NAI), Voluntary Action Indicated (VAI), and Official Action Indicated (OAI).

 

NAI signifies that the facility complies with all regulations, with no significant deficiencies found. VAI indicates that some issues were identified, but they are not severe enough to warrant regulatory action. OAI, the most critical category, means that serious compliance issues were detected, potentially leading to regulatory enforcement such as warning letters, import alerts, or product recalls.

 

Despite the improvements, IPA emphasised that the journey toward quality excellence is ongoing. The nature of regulatory scrutiny has evolved, shifting focus from fundamental Good Manufacturing Practices (GMP) compliance to more nuanced areas such as contamination control, facility maintenance, and thorough root cause analysis of manufacturing discrepancies.

 

“In the last decade, India has significantly reduced the number of regulatory violations while increasing its share of global pharmaceutical inspections,” said Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance.

 

“However, the bar for quality excellence continues to rise, and companies must remain proactive in addressing emerging compliance challenges,” Jain said.

 

Key regulatory observations over the past decade show a decline in essential cGMP training and capabilities, lab controls and core manufacturing processes, and data reliability and integrity issues.

 

At the same time, inspections have identified increased concerns in deviation from written procedures and aseptic practices, facility maintenance and sanitary conditions, and failure to thoroughly investigate discrepancies.

 

The tightening of standards is also reflected in new guidelines, such as the Quality Management Maturity (QMM) program introduced in August 2023 and clarifications on 21 CFR regulations issued in January 2025.

 

These measures reinforce the importance of continuous improvement in manufacturing processes and regulatory compliance.

 

Industry leaders believe that while progress has been made, further efforts are needed to ensure long-term sustainability and leadership in the global pharmaceutical market. With India's pharmaceutical sector playing a crucial role in global healthcare, accounting for 60 per cent of supply for global vaccine demand, the focus remains on maintaining high-quality standards and fostering trust with international regulators.