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Biopharma Shakti & regulatory agility can power India’s rise as a global innovation hub: Suneela Thatte

Nandita Vijayasimha, BengaluruTuesday, March 10, 2026, 08:00 Hrs  [IST]

Union government’s Biopharma Shakti initiative, combined with faster and more adaptive regulatory processes, has the potential to transform India into a global hub for biotechnology and pharmaceutical innovation.

Suneela Thatte, VP & head of healthcare R&D India, Merck KGaA, said India is no longer just the world’s pharmacy, it is steadily becoming a global hub for pharmaceutical innovation. With a talent base, maturing research capabilities, and robust infrastructure, India is ready to deliver high-value, end-to-end R&D across the drug development lifecycle.

From biologics and biosimilars to advanced drug delivery systems and novel therapies, India is contributing to differentiated science. Global Capability Centres are evolving into integrated R&D hubs, driving discovery, clinical development, regulatory strategy, data analytics, and portfolio management in close partnership with global teams, she added.

Initiatives like Biopharma Shakti, a Rs. 10,000 crore mission announced in the Union Budget 2026–27, aim to close these gaps by strengthening biologics, biosimilars, and biomanufacturing. If paired with regulatory agility, public–private collaboration, and sustained R&D investment, India can shift from being the world’s cost-effective medicine supplier to a genuine global innovation hub, she said.

The rapid adoption of AI, machine learning, and advanced analytics is accelerating timelines and strengthening decision-making. Backed by supportive government initiatives, stronger IP frameworks, and sustained investment in talent, India has emerged as a vital strategic partner delivering not just efficiency and scale, but innovation, quality, and long-term value, Thatte said.

Our country has made strong strides in building scientific talent and expanding its role within global R&D networks. Yet, structural gaps continue to hold back its evolution into a true innovation-led hub. The challenge is not talent, but investment with R&D spend at just 0.64% of GDP, India remains constrained in generating original science, scaling breakthrough technologies, and competing in high-value domains. This funding shortfall weakens infrastructure, limits access to advanced equipment, and fuels brain drain, leaving innovation incremental rather than transformative, Thatte told Pharmabiz.

Drug development today is more data-driven and multidisciplinary than ever, so R&D models must evolve to keep pace. Rigid structures are giving way to empowered asset teams that move fast, make decisions closer to the science, and invest boldly where the potential is greatest. Dynamic resource deployment and digital integration are the norm, scaling high-potential assets quickly, while AI, advanced analytics, and real-world data drive smarter discovery, clinical development, and portfolio optimization.

At Merck, we’re embracing this shift through cross-functional collaboration and predictive analytics, building resilient, data-driven models that deliver transformative therapies with speed and precision, she said.

Merck Healthcare R&D India plays a vital role as a global delivery centre within our worldwide R&D network. What began as an excellence centre with regulatory affairs, pharmacovigilance & patient safety, and clinical operations has expanded to multiple functions and strengthened by Centres of Excellence in Scientific Communications, Medical Writing, Biostatistics, and Project Management. Today, the India hub plays a critical role in advancing global programmes, supporting multiple stages of the drug development lifecycle, and enabling innovation. With investment in talent and infrastructure, India has become a vital partner in Merck’s worldwide R&D journey.

The new Merck Healthcare R&D facility in Brookfield, Bengaluru is a scalable, globally aligned, and future-ready R&D hub. Situated in a premium tech park, it elevates employee experience and strengthens talent attraction, a critical differentiator as India matures into a strategic capability hub. With enterprise-grade infrastructure, advanced IT backbone, and modern collaboration spaces, the facility enables expanded scope, agile teamwork, and complex healthcare innovation, said Thatte.

 
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