India's Clinical Trials: From emerging player to global leader in drug development

A number of factors coalesced to bring India to this critical juncture. Foremost, a pivotal turning point came in 2019 with the introduction of the New Drugs and Clinical Trials Rules, a sweeping regulatory overhaul that cut approval timelines by up to 40%. Ethics and regulatory clearance now takes as little as 30 to 60 days, a far cry from the drawn-out processes of the past. Within just 18 months of its implementation, more than 90 global trial applications had been filed, highlighting the industry’s rapid response.

Moreover, compliance with the ICH-GCP framework has ensured that Indian clinical data is accepted by leading agencies, including the US FDA, UK MHRA, and EMA. As a result, international confidence in India’s regulatory landscape has grown.

Secondly, India’s affordability makes it an undeniably persuasive place for conducting trials. Trials in India can offer up to 60% cost savings compared to North America and Europe. While a US-based trial might cost up to $225 million, similar studies in India often run at a fraction of that, freeing up capital for biotech firms to reinvest in broader R&D initiatives. This becomes especially relevant when the global pharmaceutical industry is facing tight R&D budgets, rising operational costs, and geopolitical instability. For instance, a significant portion of Phase III clinical trials in the US and Europe are abandoned due to funding shortfalls. In this landscape, India offers a compelling alternative that’s stable and cost-effective.

Thirdly, India's vast population of over 1.4 billion people represents one of the largest untapped patient pools globally, with a high disease burden across both non-communicable and infectious diseases. Indian sites consistently outperform global peers in recruitment timelines. In one multi-country diabetes study, an impressive 85% of Indian sites met or exceeded enrollment targets, compared to just 65% globally.

We have also made significant contributions to trial diversity, particularly in oncology. The inclusion of Indian patients introduces valuable genetic and environmental variation, making trial data more representative. This is a growing priority for regulators like the FDA, who increasingly emphasize ethnic and demographic inclusivity in pivotal trials.

Lastly, geopolitical uncertainties in regions like Eastern Europe have only accelerated India’s ascent. Global sponsors now look to India not just as a contingency plan but as a core component of their R&D strategy. Our digital infrastructure, skilled investigators, and globally networked hospitals now rival any in the West.

Leveraging the Momentum

As a result of our growing leadership in the clinical trials space, 71,000 trials are now registered within India. Pharma powerhouses like Novartis and Pfizer are doubling down, expanding their clinical operations in our country as a response to this meteoric rise. Yet as we ride this wave, there are several steps India must take to ensure this growth becomes a cornerstone of national strategy and not just a passing high tide.

First, India should incentivize local biotechs to lead trials, not just host them. Owning trials can be a transformative feat, as India looks to expand its global healthcare leadership.

Secondly, as more trials come to India, regulatory bodies must scale up capacity to maintain oversight. As they say, “Trust, once broken, is hard to rebuild.” Speed should never come at the cost of scientific rigor.

Finally, India should consider establishing regional hubs of excellence. These can be clusters that bring together CROs, hospitals, tech firms, and academic centers to create ecosystems of innovation.

India’s clinical trial revolution is a healthcare movement, a global service, and a national opportunity rolled into one. If we play our cards right, India could become the engine room of global drug development, cutting down the time and cost it takes to get life-saving therapies to patients around the world.

As Winston Churchill once said, “To each, there comes in their lifetime a moment when they are figuratively tapped on the shoulder and offered the chance to do something unique to them. What a shame if that moment finds them unprepared.”

India has been tapped on the shoulder. The world is watching. Now is the time to lead.

(Sabine Kapasi, MD & CEO, ENIRA Consulting and Nipun Vaid Mehta, Consultant Enira Consulting.)

Views are personal, and do not represent the stand of this publication.