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.

- ANJALI SINGH

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 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).