India Must Transform Biotech Sector to Harness AI Revolution

India’s biotechnology sector faces critical challenges as it attempts to adapt to the rapidly evolving landscape shaped by Artificial Intelligence (AI). Recent developments, particularly in international trade, highlight the need for significant regulatory reforms and a cultural shift in the industry. With opportunities in AI and biotech rising globally, India must act swiftly to position itself as a leader rather than a follower.

The recent announcement of 100% tariffs on branded drugs by former U.S. President Donald Trump initially raised concerns for India’s pharmaceutical exports. However, the tariffs spare India’s generic drug exports, which are integral to its pharmaceutical trade. This outcome, while somewhat reassuring, underscores a larger issue: India’s reliance on its established role as the world’s low-cost pharmacy may hinder its capacity to innovate and lead in biotechnology.

China has made remarkable strides in biotech, establishing cities like Wuxi, where drug development occurs at an unprecedented pace. Clinical trials, which take years in many Western nations, can be approved in just weeks there, thanks to substantial government investment and streamlined regulatory processes. In contrast, India appears sluggish, held back by outdated regulations that prioritize volume over innovation.

Regulatory frameworks in India predominantly cater to generic drugs, creating a bottleneck for groundbreaking therapies. The process of obtaining clinical trial approvals is cumbersome and slow, stifling the potential for rapid advancement in drug discovery. While AI is revolutionizing the way researchers design molecules and predict protein interactions, the regulatory system remains a significant barrier, hindering the transition from discovery to clinical application.

Cultural attitudes within the Indian healthcare system further complicate matters. Success is often measured by patient throughput rather than scientific discovery, which can deter clinicians from pursuing innovative research. As Kiran Mazumdar-Shaw, founder of Biocon, points out, the focus on treating patients can overshadow the need for original scientific contributions. She emphasizes that India needs not just one successful biotech company but many, each capable of producing globally competitive intellectual property.

The integrity of India’s biotech sector is also under scrutiny. Instances of unethical practices among contract research organizations have damaged the country’s reputation, making it challenging to attract partnerships and investment. Rebuilding this credibility requires establishing robust networks that link hospitals with research centers, promoting transparency and collaboration.

Dr. Moni Kuriakose of Karkinos Healthcare advocates for a shift towards independent networks in the healthcare system. He believes that integrating early-phase clinical centers within cancer institutes and fostering partnerships with global leaders is essential for revitalizing India’s standing in biotech research.

To capitalize on the potential of AI within biotechnology, India must initiate sweeping regulatory reforms. This includes expediting approval processes, adopting adaptive trial designs, and establishing AI-driven review systems. Harmonizing these regulations with global standards will also be crucial for maintaining competitiveness.

There is an urgent need to foster a culture that rewards innovation. Hospitals and healthcare providers should be recognized not only for the quantity of patients treated but also for the advancements they contribute to medical science. With an estimated potential to build a $300 billion pharmaceutical and biopharmaceutical sector by 2030 and a projected $1 trillion bio-economy by 2047, the stakes are high.

While the recent tariffs may not have immediate severe repercussions for India, they serve as a wake-up call. The country possesses a unique opportunity to leapfrog into a leadership role in biotechnology, combining affordability with innovation. However, the window for action is narrowing. If India does not act decisively now, it risks falling further behind as other nations, particularly China, accelerate their advancements in the field.