Regulatory Violations in India’s Pharma Sector Decreased by 11% in 2024
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Synopsis
The pharmaceutical industry in India has seen a notable 11% decrease in regulatory violations in 2024, reflecting improved compliance. Exports are projected to reach $65 billion by 2030, and the sector could grow to $350 billion by 2047, emphasizing India's role as a leading generic drug supplier.
Key Takeaways
- 11% decline in regulatory violations in 2024
- Pharmaceutical exports expected to reach $65 billion by 2030
- India aims to grow to $350 billion by 2047
- Largest supplier of generic drugs globally
- Biosimilar exports projected to rise fivefold
New Delhi, Feb 27 (NationPress) The pharmaceutical sector in India has experienced a significant reduction of 11% in instances of regulatory violations during 2024, as per a recent report.
The instances of regulatory violations, which are marked by the Official Action Indicated (OAI) label from the US drug authority, were at 23% in 2014. This decline indicates that the nation’s pharmaceutical industry has enhanced its compliance to meet international standards.
On a global scale, the proportion of OAI status in 2014 was 6% and has now more than doubled to reach 14%.
Overall, the number of inspections conducted by the US Food and Drug Administration (FDA) has decreased worldwide, from around 1,849 annually in 2014 to approximately 940 in 2024, whereas India's share has noticeably increased, as indicated in the Indian Pharmaceutical report.
Additionally, another recent study has indicated that India's pharmaceutical exports are expected to increase from around $27 billion in 2023 to an impressive $65 billion by 2030. This suggests that the pharmaceutical sector could expand to an estimated $350 billion by 2047.
As the largest supplier of generic medications globally, providing one in five generic drugs sold worldwide, India currently holds the 11th position in export value.
By innovating and expanding its export portfolio to include specialty generics, biosimilars, and cutting-edge products, the report highlights how India could potentially ascend to one of the top five nations in export value by 2047, according to Bain & Company's analysis.
The value of Indian biosimilar exports, currently at $0.8 billion, is predicted to grow fivefold to $4.2 billion by 2030, capturing 4% of the global market, and could reach $30-35 billion by 2047, as noted in the report. India's pharmaceutical exports, currently valued at $19 billion and comprising 70% of the total, are projected to rise to between $180-190 billion by 2047.
