Daijiworld Media Network- New Delhi
New Delhi, Feb 27: India’s pharmaceutical sector has reported an 11 per cent decline in regulatory violations in 2024, marking a significant improvement in compliance with global standards, according to a recent industry report.
The number of regulatory violations flagged under the Official Action Indicated (OAI) status by the US Food and Drug Administration (FDA) stood at 23 per cent in 2014. The latest decline underscores the industry’s efforts to enhance quality control and meet international regulatory expectations.
While India’s regulatory non-compliance rate has decreased, the global share of OAI status has surged, more than doubling from 6 per cent in 2014 to 14 per cent in 2024. Despite a reduction in total FDA inspections worldwide—from approximately 1,849 annually in 2014 to around 940 in 2024—India’s share of these inspections has increased, indicating its growing role in the global pharmaceutical landscape.
Meanwhile, a separate report projects that India’s pharmaceutical exports are set to witness exponential growth, rising from approximately $27 billion in 2023 to $65 billion by 2030. The industry is expected to expand further, reaching an estimated valuation of $350 billion by 2047.
As the world's largest supplier of generic drugs—contributing one in five generic medicines sold globally—India currently ranks 11th in terms of export value. However, by diversifying its portfolio to include specialty generics, biosimilars, and innovative pharmaceutical products, the country is poised to break into the top five exporting nations by 2047, according to a report by Bain & Company.
Indian biosimilar exports, currently valued at $0.8 billion, are projected to grow fivefold to $4.2 billion by 2030, capturing 4 per cent of the global biosimilars market. By 2047, this segment is expected to soar to an estimated $30-35 billion.
Additionally, India’s pharma exports, which currently stand at 70 per cent of total production and are valued at $19 billion, are forecasted to witness a tenfold increase, reaching $180-190 billion by 2047.
With increasing compliance, regulatory improvements, and a strategic focus on innovation, India’s pharmaceutical industry is well-positioned to strengthen its global footprint in the coming decades.