India is the pharmacy of the world. But we are losing the drug development race

In India, it can take as much as two years just to get approval to start a clinical trial. By the time a firm starts a Phase I trial in India, the Chinese counterpart working on the same target would already have Phase II clinical data and have licensed their drug to Novartis for a billion dollars — a blistering pace that has made China the global leader in early-stage drug development.

This is a huge problem in our fast-moving era, with Generative AI revolutionising the design of medicines, cutting development timelines from years to months, and opening a path to preventing and curing diseases that kill millions of people each year but have resisted conventional approaches. AI also makes possible the democratisation of truly personalised medicines against terminal cancer, lifelong autoimmune conditions, and genetic diseases.

India, replete with both computer science talent and biologics expertise, is perfectly positioned to benefit from the convergence of AI and medicine — our biotech companies can leapfrog legacy pharmaceutical giants with a remarkably rapid and efficient AI-first approach to drug design and development.

While the potential exists, unfortunately, India is losing the drug development race. Despite being the pharmacy of the world — the largest manufacturer of generic medicines, which save millions of lives across the world each year — Indian firms don’t develop novel medicines. The big money in pharma is in new medicines, not old ones, which explains the sobering statistic that the entire Indian pharmaceutical industry’s yearly revenue is approximately $50 billion, while Merck, a single US pharma company, makes approximately $64 billion.

The biggest impediment to the development of new medicines in India is the clinical-trial regulatory framework. There are fewer than 40 first-in-human Phase I clinical trials of novel pharmaceuticals each year in India, in comparison with 800-plus in the US, and 1,000-plus in China. Our Central Drugs Standard Control Organisation (CDSCO) refers clinical trial applications to subject expert committees (SECs) for advice on approval. There is only one SEC for each area of medicine — they typically take at least six months, and sometimes years, to approve clinical trial applications, instead of the few weeks it takes in the US and China.

The government is aware that things need to change. In his Independence Day speech last year, the Prime Minister challenged the nation to research and develop the “most effective medicines for the welfare of mankind.” In this year’s budget speech, the Finance Minister announced the innovation-focused Biopharma SHAKTI initiative, which includes strengthening CDSCO to meet global approval timeframes.

Unfortunately, as new AI-powered startups develop ever more novel medicines at an accelerating pace, even the increased reviewer capacity she has promised will likely not be enough to process these trial applications fast enough.

There is a proven approach that can eliminate this bottleneck. For Phase I & II clinical trials, we propose that any hospital, medical college, or university, as well as research institutes such as those under ICMR, CSIR, and DBT, should be empowered to set up their own subject-expert committee for clinical trials. These SECs would need to be registered with CDSCO and have a specific minimum composition, including a medical doctor, a biomedical researcher, a pharmaceutical manufacturing expert, and a biostatistician. Biotech and pharmaceutical companies developing new medicines would be able to choose any registered SEC to apply to, and any such SEC would be able to give permission to start an early-phase clinical trial. CDSCO would be notified, but would not participate in the decision-making.

CDSCO already goes through a similar process for registering ethics committees, and could create such a process for SECs via updated rules without the need for new legislation.

This is the same approach that Australia has used for 30 years, without any worse safety outcomes than the US. Australian clinical trial data is considered gold-standard across the world, and many countries are moving towards that approach to clinical trial regulation, including the US, where this is part of the Senate health committee’s current package of proposed reforms.

This body of evidence and global acceptance demonstrates that the proposed approach of distributing the scrutiny of clinical trials across multiple qualified bodies has the potential to massively accelerate the pace of pharmaceutical innovation in India without at all compromising patient safety; indeed, patients may well be better protected by decentralised expert committees acting in parallel, each with the time to deeply and thoroughly review the few applications in front of them, rather than a single committee overburdened with every file at once.

If we don’t adopt an approach of this kind to accelerate clinical trial approvals, India runs the risk of falling forever behind in the field of medicine. Western pharmaceutical companies aren’t interested in developing a vaccine against adult TB, a cure for oral cancer, or treatments for other life-threatening diseases that are highly concentrated in India, so crores of Indians will continue to die from these diseases each decade. India’s health will be controlled by the West and China, with access to new medicines gated behind unaffordable prices and rising geopolitical barriers, and we may be left defenceless in the face of rising biosecurity threats enabled by the same AI that is now accelerating drug development.

If we adopt this approach and eliminate the main bottleneck to conducting clinical trials in India, India can and will lead the world in developing novel medicines.

Sankaran is founder, PopVax, an Indian full-stack biotech developing novel vaccines and immunotherapies using generative AI. Manur is professor of Economics, Takshashila Institution