A note from 2026: I first wrote this in early 2024. Since then, the M72 tuberculosis vaccine has moved deeper into late-stage trials and India’s role in global clinical research has only grown more consequential. I’m republishing it here largely as written, because the underlying argument — that India’s demographics make it uniquely positioned to lead clinical trials for the Global South, if it can rebuild trust in its institutions — has, if anything, become more urgent.

Getting clinical — the challenges of getting new drugs from the lab to the clinic

Each year, over 1.5 million people¹ die from tuberculosis. Nearly 30% of these deaths², many of them preventable, take place in India. A new vaccine, called M72, can help by fighting the latent TB infections responsible for a number of these deaths. So why is it not already in clinics?

A key challenge to commercializing this potentially life-saving vaccine has been running large clinical trials. Trials are essential to making such drugs available: they confirm safety, ascertain efficacy, and establish recommended dosage. But executing them is hard, because finding enough eligible patients to enroll is difficult. Trials also require monitoring and supporting patients through the process, which demands skilled administrators and caregivers — making trials even more expensive to run at scale.

Opportunity in diversity — what India can offer

Making trials easier, starting with enrolling enough patients, can stem the tide of disease. Here, India — with its population of 1.4 billion, which today accounts for just 4% of all clinical trials³ — must rise to the occasion. Running more trials in India could deliver adequate patient enrollment, staffing with enough administrators and nurses, and the ability to do all of this affordably.

It is not just numbers; density plays a role too. Demographic trends such as urbanization, which concentrates over 500 million Indians into urban areas, mean India can rely on existing medical infrastructure to enroll the right patients. Cities also concentrate the English speakers and skilled professionals needed to conduct trials successfully. Administering these trials creates a potential employment pathway for India’s growing youth workforce — English-speaking and well-trained in science.

When it comes to clinical trials, India offers more than numbers, and benefits from more than employment and economics. Historically, drugs have been developed based on studies in largely Caucasian populations. This lack of diversity has real-world consequences: drugs that patients of color rely on may not work as well for them. Recent findings⁴ from Queen Mary University of London showed that clopidogrel, a drug designed to reduce the risk of recurrent heart attacks, was twice as likely to be ineffective for those of South Asian descent, owing to a subtle genetic difference. India’s ethnic diversity presents an opportunity to study drug behavior in heterogeneous, non-white populations — making not just the science, but the life-saving drugs themselves, more inclusive.

Trial and error — the controversy around trials

Pharma companies have been vilified for their drug pricing and development decisions, and research shows that some⁵⁶ of this criticism is earned. But the challenges of drug development are compounded by the fact that most clinical trials, already expensive, fail to yield promising new drugs⁷. To stay commercially viable, pharma firms — forced by the market — choose which diseases to pursue very carefully. In practice, this means firms can shy away from drugs for diseases that take a heavy humanitarian toll but lack an adequate market. A number of pharma initiatives over the last decade⁸ have sprung up to address this, but given market forces, it remains a challenge. Ultimately, private profits are essential for innovation, and disease keeps people poor. This is a vicious cycle that impairs global health for much of the Global South.

By stepping up, India stands to benefit domestically and to help peers across the Global South. Fundamentally, India’s democratic setup should make it easier to interrogate — and eventually build trust in — the underlying data, which is crucial to global acceptance of drugs studied through trials there. Instead, clinical trials have been controversial in India. The most prominent public debates erupted in 2012, after patients in clinical trials died, prompting public uproar⁹. A parliamentary committee later found major shortcomings at India’s drug regulator, the Central Drugs Standard Control Organization (CDSCO)¹⁰, including collusion among drug companies and doctors. This is not only morally unacceptable; it is a surefire way to produce poor-quality drugs that help no one.

A booster shot — why India must try again

But this is not the India of 2012. There is room for greater transparency through the digitization of records, and significantly less tolerance for corruption. India’s aspirations, too, are now different. If we want to Make in India, we must make every effort to move up the value chain — not just manufacturing generics, as we already do for the world, but also building first-class institutions and practices to show those drugs are safe and effective: clinical trials infrastructure. Accelerating trial adoption could be a stepping stone that helps local pharma firms move from manufacturing generics to original R&D that creates novel drugs.

Moreover, India’s economic growth, combined with policy interventions like Ayushman Bharat — which aims to become the world’s largest health insurance scheme, covering 500 million people, more than the combined populations of the US and UK — can address the market-size challenge of drug development. By concentrating the bargaining power of these beneficiaries into a single insurer, the government can also help ensure resulting drugs are priced fairly.

A bitter pill — the discrepancy between clinical research and disease burden

While it is vital to call out deaths from malpractice, it is also immoral to let patients die while drugs that could cure them wait to reach the market. This is a bitter pill to swallow. Over the last decade, India contributed just 4% of all clinical trial participants, compared with 30% in the US¹¹. India accounts for 20% of the global burden of respiratory infectious diseases and 15% of cardiovascular diseases, but for only 3% and 4% of the related clinical trials, respectively¹².

It must all start with more effective clinical governance, greater transparency, and further public and private education. The answer to historic malpractice cannot be to stifle progress; it must be to strengthen our resolve — and our medical and governing institutions. An investment in clinical trials infrastructure can yield cheaper new drugs that improve health outcomes at home and across the Global South, while creating avenues for employment, economic growth, and scientific capacity. This is a wonder drug of a proposition, and India would do well to take it. After all, the world is watching, and patients are waiting.