Innovating in India: Biotech sector must lose its handcuffs in AI age
From regulatory reforms to rewarding research and discoveries instead of patients treated, the existing ecosystem needs many changes to be future-ready
Every headline about Donald Trump’s tariffs sounds like another disaster for India. Yet this time, the blow landed softer than feared. His 100% duties fall on branded drugs, sparing India’s generic exports — the foundation of its pharmaceutical trade. That is the silver lining. The darker truth is that India was even holding its breath. An industry that should be shaping the future was instead bracing for Washington’s next move. That is the real vulnerability.
Trump’s action shows how fragile India’s position is when it leans too heavily on the past — on its role as the world’s low-cost pharmacy. The future of medicine is being written in biotechnology and Artificial Intelligence (AI), and those who master it will define global health care. India has the talent, the patients, and the history to lead. What it lacks is the urgency to break free from the bureaucracy and inertia that keep it chained.
China understood this long ago. It has built entire biotech cities like Wuxi, where molecules move from discovery to trials to production in months. Clinical trials that take years in the West are approved there in weeks. Behind it all is a national priority backed by billions in State funding, fast-track regulation, and a vast patient base. Confronting that juggernaut would be risky, so Trump avoids it. Instead, he turns his fire to India, where it is politically safer.
That contrast should sting. While China sprints forward, India remains stuck in the past. Regulations designed for generics slow breakthrough therapies to a crawl. Hospitals measure success by patient volume rather than discovery. A medical culture that once prided itself on frugal innovation now risks being trapped by it — delivering affordability without originality. Unless these handcuffs are broken, the biotech revolution will happen elsewhere.
AI is already transforming drug discovery. It is designing molecules, predicting protein interactions, and generating therapies at speeds that were once unimaginable. What took a decade, can now be done in months. But then comes the bottleneck: Clinical trials. It is like landing in a jet after flying at supersonic speed — only to continue the journey on a bullock cart. That is the reality of India’s regulatory system. AI is opening the skies of possibility, yet discovery collides with the crawl of outdated approvals and trial processes. This is the first handcuff — regulation built for monitoring generics, not enabling frontier science.
The second handcuff is culture. Indian health care rewards throughput — how many patients are treated — not the discoveries advanced. Too many clinicians serve as clerks in multinational trials rather than leaders of their own. Research is seen as a distraction from patient care rather than its highest form.
The third handcuff is credibility. A handful of unethical contract research firms and failed government studies tarnished India’s reputation. In biotech, credibility is currency. Without it, data is discounted and partnerships fade.
The fourth handcuff is mindset. India’s genius for frugal innovation has saved millions of lives, but making others’ discoveries cheaper is not the same as leading. Without original intellectual property, India risks being sidelined while others set the pace.
Kiran Mazumdar-Shaw has been sounding this alarm for years. Biocon, the company she built, proved that advanced biologics and biosimilars could be developed in Bengaluru in keeping with world standards, making insulin and cancer therapies affordable worldwide. Yet even she has struggled against the same barriers: Hospitals focused on numbers over research, regulators clinging to outdated frameworks. Her message is clear — India can’t depend on one Biocon. It needs a hundred, each creating original science and global-class IP.
Her prescription is sweeping regulatory reform: AI-enabled reviews, adaptive trial designs, and fast-track approvals for precision medicine and rare diseases. Without this, India will fall further behind in a field where speed defines leadership.
Dr Moni Kuriakose of Karkinos Healthcare is equally blunt. He argues that India’s credibility can only be rebuilt through independent networks linking hospitals, with early-phase centres embedded in cancer institutes, supported by preclinical labs and partnerships with global leaders. That is how Indian data will once again command respect.
To seize this AI-driven opportunity, India must first reform regulation: Approvals must be faster, adaptive designs routine, AI-driven reviews standard, and harmonisation with global agencies the norm.
It must build credibility through networks. Independent hospital consortiums can restore trust and scale.
There is also a need to create early-phase hubs. Every major cancer hospital should host trial units linked to labs and global partners.
The country must do all it can to unleash entrepreneurship. With AI embedded across discovery and diagnostics, Indian innovators can mine anonymised datasets for insights that no one else is seeing.
Along with all this, it must ensure it rewards research, not just volume. Hospitals and clinicians should be recognised for discoveries advanced, not only patients treated.
Mazumdar-Shaw believes India could build a $300 billion pharma–biopharma sector by 2030 and a $1 trillion bio-economy by 2047. But without regulatory reform and a culture shift, these numbers will remain fantasy.
Trump’s tariffs may not cut deep today, but they should jolt India into action. The country still has a rare chance to leapfrog into biotech leadership — combining affordability with originality, scale with credibility. But the window is closing fast. If India hesitates, China will lock in its lead, and India will be left clinging to an old playbook in a world already moving on.
Vivek Wadhwa is CEO, Vionix Biosciences. The views expressed are personal
