India's pharmaceutical industry has built a strong global position on scale and cost competitiveness, but its next growth phase will depend on quality, regulatory trust, supply-chain resilience, digital capability and innovation, according to a joint Grant Thornton Bharat-Ficci report.

India ranks third globally in pharmaceutical volume but 11th by value, highlighting the scope to move into higher-value and complex manufacturing. The country exported drugs worth $30.5 billion to 191 countries in FY2024-25 and supplies about 20 per cent of global generic medicines.

The report identifies data integrity as a major weakness. Data-integrity issues featured in roughly 60 per cent of FDA warning letters involving Indian pharmaceutical sites in FY2025, compared with about 15 per cent globally, making reliable and auditable data increasingly central to India's regulatory credibility.

“Global life sciences companies are looking beyond capacity and cost,” said Bhanu Prakash Kalmath S J, partner and healthcare industry leader at Grant Thornton Bharat. Innovation, supply resilience, regulatory confidence, data integrity, AI and the ability to manufacture complex biopharma products are becoming key considerations, he said. 

What’s driving the shift?

The shift, according to the report, is also being driven by growing demand for biologics, biosimilars, sterile injectables, antibody-drug conjugates and gene therapies, which require more specialised infrastructure and stronger quality systems.

Supply-chain resilience is another priority, particularly for APIs and key starting materials. While PLI schemes have expanded domestic capacity, the report says dependence on concentrated external sources remains high in some categories.

Digital manufacturing is emerging as a further competitive edge, with automation, traceability, analytics, digital quality systems and supply-chain visibility increasingly linked to productivity and regulatory confidence. The report cautions that technology will deliver value only when backed by strong operational discipline and reliable data.

Policy support has already boosted capacity. The pharmaceutical PLI scheme has attracted ₹45,774 crore of investment against a ₹15,000 crore outlay, generating more than 113,000 jobs as of March 2026. The report argues that future incentives should increasingly reward innovation, technology adoption, quality, resilience and sustainability, rather than production volumes alone.

The report also flags shortages in specialised skills such as AI-driven drug discovery, regulatory sciences and computational biology, calling for stronger industry-academia links and better pathways to commercialise research.    

Its central message is clear: 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.