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Dr. Madhuresh Kumar Sethi: Revolutionizing Pharmaceutical Access Through Science and Strategy

Dr. Madhuresh Kumar Sethi Pharmaceutical Access | Viatris | The Enterprise World

“Discovery is about seeing what everyone has seen and thinking what no one else has thought.” This philosophy defines the journey of Dr. Madhuresh Kumar Sethi, Head Chemical Research Division R & D Viatris (Mylan & Matrix Labs) a pharmaceutical leader who has spent his career turning scientific ideas into life-saving medicines. He began in synthetic chemistry, developing non-infringing, cost-effective routes for APIs, and went on to lead high-impact R&D teams that managed projects from the lab bench to commercial scale.

At Viatris (formerly Mylan & Matrix Labs), Dr. Madhuresh Kumar Sethi led Chemical Research & Scientific Affairs, driving API development, regulatory filings and intellectual property strategy. His work has contributed to the launch of generics like lansoprazole, sertraline and pitavastatin calcium, the A major regulatory milestone: Iron-complex nanoparticles for intravenous administration have secured approvals from both the EU (FCM, 2024) and the US FDA (Iron Sucrose, August 2025), marking a significant advancement in clinical iron therapy, and the U.S. FDA approval one of peptide out of long series; glucagon in 2024. He has also guided teams through challenging para-IV litigations, helping secure market exclusivity for critical drugs.

With over 100+ patents and research papers, ( contribution to The Royal Society of Chemistry’s Book Chapter 2, Biocatalysis – A Greener Alternative in Synthetic Chemistry (DOI: 10.1039/9781782629993-00044) Dr. Madhuresh Kumar Sethi combines scientific depth with business insight. He is passionate about sustainable pharmaceutical solutions, applying green chemistry, asymmetric synthesis and biocatalysis to make drug development more efficient and eco-friendly. Beyond R&D, he serves as an Independent Director (IICA), a BRSR & ESG expert, and an Indian Patent & Design Agent, helping companies align science, sustainability and strategy.

A Career Defined by Solving High-Stakes Challenges

Building on his academic foundation with a Master’s and PhD, Dr. Madhuresh Kumar Sethi embarked on an industrial career driven by a passion for solving the impossible. His early years at JK Drug & Pharmaceuticals honed his skills in scaling lab processes, a capability that became his hallmark. He then served as Team Leader at Aurobindo Pharma Ltd, further strengthening his leadership experience. However, it was at the entrepreneurial Metrix Pharmaceuticals where his leadership was truly forged in fire, guiding high-stakes projects and pioneering complex pharmaceutical solutions.

He excelled in high-pressure environments, guiding teams through high-stakes litigation and innovative scale-up projects for blockbuster drugs. Over time, his career expanded to include the launch of complex therapies, notably pioneering peptide-based treatments. Even after retirement, he remains active in patent law and AI, applying his extensive expertise to optimize next-generation medicines. 

The Foundations of a Scientific Mind

Dr. Madhuresh Kumar Sethi journey into science began with an unexpected obstacle that turned into a blessing. When domicile rules blocked his path to MBBS, he landed at Punjab University’s chemistry department almost by chance. What seemed like a compromise became the foundation of an exceptional career His B.Sc. (Honour School in Chemistry) program offered interdisciplinary studies across English, Physics, Mathematics, Geology, and Biochemistry etc 

Coupled with mixed-hostel living, it exposed him to diverse perspectives and future leaders Eminent personalities across India — including MPs, MLAs, ministers from the Centre, Punjab, Himachal Pradesh, Jammu & Kashmir, and Haryana, celebrated cricket and hockey players, renowned beauty pageant winners, acclaimed film stars, and esteemed judges of the High Courts and the Supreme Court — have been part of this journey., including Dr. Manmohan Singh . Two key lessons emerged: a professor’s guidance to “believe your observation” as the essence of science, and a nitric-acid accident that reinforced the absolute importance of laboratory safety.

The Most Enduring Academic Lessons

Dr. Madhuresh Kumar Sethi Pharmaceutical Access | Viatris | The Enterprise World

When reflecting his university experience, Dr. Madhuresh Kumar Sethi describes it as far more than a chemistry degree; it was a formative lesson in connectivity. While his degree was in Chemistry, his education was profoundly interdisciplinary. He attended classes across the entire sciences spectrum which cultivated a unique, holistic mindset. This broad exposure taught him that complex problems are rarely solved within the silo of a single discipline.

The most enduring academic lessons, however, were those learned through experience. A senior professor instilled in him a fundamental principle he carries to this day: “Trust your observation observation is the key in science.” This respect for empirical data was cemented by a harrowing personal experience when a nitric-acid accident in an early practical session sent him to the hospital. It was a stark reminder that safety is the foundation of all scientific work, a principle that has guided his leadership in maintaining rigorous, secure laboratory environments.

Turning Academic Insights into Industrial Impact

Dr. Madhuresh Kumar Sethi’s academic journey laid a strong foundation for his industrial career, with each phase building on the last. His chemistry studies, enriched by interdisciplinary exposure from geology to biochemistry, developed his ability to connect diverse fields. Two formative experiences shaped him: a professor’s advice to “Trust your observation” and a nitric-acid accident that highlighted the critical importance of safety.

These academic lessons proved invaluable when he transitioned to industry, where he faced the critical challenge of scaling laboratory processes to commercial production. He quickly learned that the theoretical principles from university had to be tempered with practical wisdom. The most important industrial lesson was that “a seemingly trivial failed experiment in the lab can become a major issue at scale.” This insight reshaped his approach, focusing on meticulous data recording, anticipating scale-up challenges, and designing safe, reproducible processes that apply academic lessons to real-world manufacturing.

A Story of Scientific Audacity

Dr. Madhuresh Kumar Sethi work at Matrix wasn’t confined to the lab; it played out in courtrooms, where scientific innovation became a powerful legal weapon. The strategy was audacious: instead of circumventing patents, his team invented entirely new, non-infringing manufacturing processes to challenge blockbuster drugs directly.

The defining moment came with Perindopril Erbumine which faced “impossible” challenges using a globally unprecedented reagent and creating a chiral ester without standard methods Dr. Madhuresh Kumar Sethi team engineered a brilliant workaround. Initially met with disbelief in court, the process proved scalable, leading the opposition to settle. This landmark victory secured ~$100M for Matrix and enabled the launch of its formulations division.

Dr. Madhuresh Kumar Sethi subsequently led first-to-file cases for major drugs like Lansoprazole and Sertraline, successfully defending them against industry titans like Pfizer and Teva. His role expanded after Mylan’s acquisition of Matrix, centering on a rigorous pipeline of developing non-infringing processes, advanced impurity profiling, and deep, cross-functional collaboration with formulation teams to ensure robust and successful product launches on the global stage.

A U.S. & UAE Tour of Pharmaceutical Innovation

Following his superannuation, Dr. Madhuresh Kumar Sethi embarked on a strategic U.S. tour to engage with global pharmaceutical innovation, where key industry events revealed exciting frontiers beyond traditional generics.

  • CPHI Philadelphia: Gained a comprehensive, high-level view of the global supply chain, partnership opportunities, and emerging market dynamics.
  • American Peptide Society (San Diego) & Boulder Peptide Symposium: Immersed himself in the growing peptide therapeutics field, engaging top producers and pinpointing a key challenge the urgent need to optimize inefficient, high-waste synthesis methods.
  • Lipid Nanoparticle Sessions (Boston): Explored advanced delivery systems, recognizing their vital role in making complex drugs, like peptides, more bioavailable and effective in the human body.
  • CMO/CRO Outsourcing Event (New Jersey): Analyzed the evolving partnership models and outsourcing trends that are shaping how modern pharmaceutical companies operate and scale.
  • INTA International Trademark Association Dubai Workshop: Integrating Intellectual Property, Finance, and Valuation & opening of INTA’s regional office in Dubai marks a pivotal milestone in the association’s global strategy to expand its regional presence and strengthen intellectual property (IP) protection in emerging markets

This journey crystallized his current mission: to drive innovation in peptide process optimization, making next-generation medicines more sustainable and accessible.

Recognition and Thought Leadership

Dr. Madhuresh Kumar Sethi Pharmaceutical Access | Viatris | The Enterprise World

Throughout his distinguished career, Dr. Madhuresh Kumar Sethi contributions have been recognized by his peers and the industry, reflecting a commitment to both scientific excellence and knowledge sharing.

Here are the recognitions and leadership titles:

  • Prestigious Industry Award: Honored with the Metrix Achievement Award for his pivotal role in a landmark litigation case, a victory that delivered immense value and helped shape the company’s future.
  • Prolific Research Contributor: Author and co-author of over 100 research publications, establishing a substantial body of work that advances pharmaceutical science.
  • Engaged Industry Voice: Actively shares his insights and experience on platforms like LinkedIn, CXO Lanes fostering dialogue on the future of pharma.
  • Featured Expert: His expertise has been showcased in leading publications, including features in STALWARTZ, Forbes India, ACCSO magazine: Business India & forthcoming Most Empowering Business Leaders to Watch in Healthcare 2025 in Business world 

A Focus on Optimization and Intelligence

Dr. Madhuresh Kumar Sethi Pharmaceutical Access | Viatris | The Enterprise World

Even after a distinguished corporate career, Dr. Madhuresh Kumar Sethi remains passionately engaged in shaping the future of pharmaceuticals, focusing on solving next-generation complex challenges through a powerful trio of interests.

Here the interests mentioned:

  • Strategic Upskilling: He proactively qualified as a Patent Agent, cleared the Directorship exam, and earned AI certifications from ISB to explore its applications in leadership and pharma R&D.
  • Continued IP Leadership: He remains actively involved in the core areas of patent filing, litigation support, and trademark work, leveraging his deep expertise to protect innovation.
  • Defining Mission: Peptide Optimization: His primary focus is tackling a major industry bottleneck: inefficient peptide synthesis, where current methods use nearly 15,000 liters of solvent & other reagents to produce a single unit of peptide.
  • Ultimate Goal: To develop optimized processes that cut waste, reduce costs, and scale production, making next-generation medicines more sustainable, efficient, and accessible to meet growing global demand.

Professional Affiliations (Partial List)

  • American Chemical Society            
  • American Association for the Advancement of Science
  • Indian Council of Chemists
  • Chemical Research Society of India
  • Indian peptide society
  • American peptide society
  • European Peptide Society
  • ACSChemistry & Law.
  • ACS Carbohydrate Chemistry & Chemical Glycobiology Division
  • PART OF ACS CARB MEMEMBERSHIP COMMITTEE
  • ACS Professional Relations Division
  • ACS Scholarly Communication Member
  • American Association for the Advancement of Science 
  • The Asian Patent Attorneys Association
  • Elite member of Board Stewardship

An Open Letter to the Next Generation of Healthcare Leaders

Dr. Madhuresh Kumar Sethi Pharmaceutical Access | Viatris | The Enterprise World

To the future pioneers of our industry,

In a field driven by data and deadlines, it’s easy to overlook the principles that drive meaningful progress. 

Dr. Madhuresh Kumar Sethi urges emerging professionals to uphold one core value: be unwaveringly honest. Integrity binds all else. He emphasizes that there is no failed experiment, only data and learning opportunities treat every result with curiosity, especially the unexpected. 

Finally, he champions optimization: improving yields, reducing waste; presently waste is as high as above 15000 time solvents & reagent for 1 unit of peptide, and modernizing processes is crucial, particularly in peptide therapeutics & Responsible use of AI in R & D

Doing more with less ensures the next generation of life-saving medicines is scalable, sustainable, and accessible to all.

The next breakthrough depends not just on what you discover, but on how you choose to build.

With hope for the future,

Dr. Madhuresh Kumar Sethi

 Head,  Matrix Mylan Viatris

Key Takeaways:

  1. Champion Interdisciplinary Thinking to Drive Innovation
  2. Trust Empirical Observation Over Conventional Assumptions
  3. Build Safety and Integrity into Every Process
  4. Turn Legal Challenges into Scientific Opportunities
  5. Master Both Discovery and Commercialization
  6. Leverage IP Strategy as a Competitive Business Advantage
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