India's pharmaceutical industry has established a strong global presence, ranking third globally in pharmaceutical volume but 11th by value, according to a joint Grant Thornton Bharat-Ficci report. The country exported drugs worth ₹2,57,000 crore ($30.5 billion) to 191 countries in FY2024-25 and supplies approximately 20% of global generic medicines. However, the report indicates significant scope for moving into higher-value and complex manufacturing segments.
Data integrity has emerged as a major weakness, with data-integrity issues featured in roughly 60% of FDA warning letters involving Indian pharmaceutical sites in FY2025, compared with about 15% globally, as reported by the Grant Thornton Bharat-Ficci study. This disparity makes reliable and auditable data increasingly central to India's regulatory credibility and global competitiveness. The report emphasizes that global life sciences companies are now looking beyond capacity and cost to focus on innovation, supply resilience, regulatory confidence, and data integrity.
The pharmaceutical sector is experiencing growing demand for specialized products including biologics, biosimilars, sterile injectables, antibody-drug conjugates and gene therapies, which require more specialized infrastructure and stronger quality systems, according to the report. Supply-chain resilience remains a priority, particularly for APIs and key starting materials, with the report noting that while PLI schemes have expanded domestic capacity, dependence on concentrated external sources remains high in some categories.
The pharmaceutical PLI scheme has demonstrated significant success, attracting ₹4,15,774 crore ($45,774 crore) of investment against a ₹1,50,000 crore outlay, generating more than 1,13,000 jobs as of March 2026, as reported by the Grant Thornton Bharat-Ficci study. The report argues that future incentives should increasingly reward innovation, technology adoption, quality, resilience and sustainability, rather than production volumes alone. Digital manufacturing is emerging as a competitive edge, with automation, traceability, analytics, and digital quality systems increasingly linked to productivity and regulatory confidence.
The report identifies shortages in specialized skills including AI-driven drug discovery, regulatory sciences and computational biology, calling for stronger industry-academia links and better pathways to commercialise research. The central message emphasizes that India's next pharmaceutical advantage will not come simply from making more drugs, but from becoming a more trusted producer of complex, high-value medicines through enhanced quality systems, regulatory compliance, and technological capabilities.
