By NK Ganguly, Former Director General, Indian Council of Medical Research    

When HIV/AIDS threatened to become a generational catastrophe across the developing world in the early 2000s, it was India that broke the economic barrier producing antiretrovirals at a fraction of the prevailing cost and putting life-saving treatment within reach of millions. That moment captured something essential: India’s ability to harness scientific capability and manufacturing scale in service of a larger human purpose. Supplying over 20% of global generic medicines by volume today, India’s pharmaceutical industry is one of the most consequential of our era and that foundation is the launchpad for an even more ambitious chapter now beginning to take shape.

The economic logic is compelling. A patented first-in-class medicine commands significantly higher margins and longer market exclusivity than a generic equivalent. India’s pharma exports are close to $30 billion, a remarkable feat; yet its share of global new molecular entity approvals remains below 2%. The gap between contribution and credit is wide and closing it represents both a strategic imperative and a substantial economic opportunity.

Nations that invested deliberately in their biopharma ecosystems, building clinical trial-friendly environments, robust IP frameworks, and targeted innovation incentives have demonstrated what focused ambition can achieve. India’s structural advantages—a vast and diverse patient population, world-class scientific talent, and significant cost efficiencies—represent a far stronger foundation to build upon.

India accounts for only 1-2% of global clinical trials, a figure that understates both its capacity and its potential. Recognising this, the 2026 Budget made a decisive intervention: the Biopharma SHAKTI scheme proposes a nationwide network of 1,000 accredited clinical trial sites, alongside strengthened regulatory capacity and expanded pharmaceutical education infrastructure. These are meaningful commitments, and whilst the full benefits will take time to materialise, the policy direction is clear and the foundations are being laid.

India’s innovation ecosystem is more developed than it is often given credit for. Biotech clusters in Hyderabad, Pune, and Bengaluru have evolved into credible research hubs, and global capability centres conducting genuine drug discovery and data science work are a powerful testament to the global confidence being placed in India’s scientific workforce.

Importantly, India’s participation in advanced drug development is not nascent. Through open licensing frameworks, India has manufactured complex medicines including Hepatitis C antivirals and Covid-19 vaccine, making them accessible at scale. Indian industry has also demonstrated growing capability in biologics, producing biosimilar versions of blockbuster therapies such as trastuzumab, rituximab, nivolumab, and, more recently, semaglutide as well as critical medicines like tenecteplase, a clot-busting drug used in cardiac care. These are not peripheral achievements; they signal a sector already operating at the frontier of pharmaceutical complexity, and ready to take the next step towards origination. The Promotion of Research and Innovation in Pharma MedTech Sector scheme’s Rs 5,000-crore commitment to pharma and medtech R&D, combined with the Ayushman Bharat Digital Mission’s health data infrastructure, further positions India as one of the most promising AI-enabled drug discovery environments.

Sustaining this momentum requires focused attention in a few areas. Translational research, the bridge between lab discovery and clinical development, warrants deeper investment with stronger technology transfer capacity in academic institutions to ensure India’s basic science converts more consistently into globally competitive drug candidates. Risk capital for late-stage innovation remains limited domestically; building a more mature biotech investment ecosystem with longer-horizon institutional funding is essential to retain the value of Indian innovation within. And while industry-academia collaboration is growing, it has room to deepen further; sustained co-development partnerships and shared IP frameworks would amplify what already exists.

India’s path forward is about building systematically on foundations that exist. Regulatory evolution and streamlined pathways for innovative molecules aligned with international standards will strengthen confidence among domestic and global innovators alike. AI and real-world evidence, underpinned by sound data governance, could position India as the world’s most cost-effective drug discovery environment. And focusing innovation on therapeutic areas where India holds a genuine structural advantage (infectious disease, metabolic disorders, oncology) will create a more durable global leadership than attempting to compete across all of pharma R&D simultaneously.

India’s pharmaceutical journey has been defined by purpose, scale, and the ability to deliver what the world needs. The scientific talent is world-class, the ecosystem is maturing, and policy intent is translating into meaningful investment. The transition from pharmacy to pioneer is well underway and with sustained commitment from industry, academia, investors, and government, India has every reason to lead the next era of global pharma innovation.

Disclaimer: The views expressed are the author’s own and do not reflect the official policy or position of Financial Express.