Regulatory violations in India’s pharma sector fell 11pc in 2024

The regulatory violation instances which entail Official Action Indicated (OAI) tag by the US drug regulator, stood at 23 per cent in 2014. The drop suggests that the country’s pharma industry has improved compliance to be at par with international standards.

Globally, the share of OAI status in 2014 stood at 6 per cent and has now more than doubled standing at 14 per cent.

The total number of US Food and Drug Administration (FDA) 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 report said.

Meanwhile, another recent report showed that the country’s pharmaceutical exports are projected to double from approximately $27 billion in 2023 to reach $65 billion by 2030. It showed that the pharma industry can further grow to an estimated $350 billion by 2047.

While India is the largest supplier of generic drugs globally, accounting for one in five generic drugs sold worldwide, the nation currently ranks 11th in terms of export value.

By innovating and diversifying its export basket to include specialty generics, biosimilars, and innovative products, the report emphasizes how India can potentially secure a position among the top five nations in export value by 2047, according to the report by Bain & Company.

Indian biosimilar exports, currently valued at $0.8 billion, are also projected to grow 5 times to $4.2 billion by 2030, capturing 4 per cent of the global market, and reach $30-35 billion by 2047, the report said. India’s pharma exports at 70 per cent and valued at $19 billion, are projected to grow to $180-190 billion by 2047. (IANS)

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