Every tablet, every injection, every life-saving vial carries within it a story. A story of rigorous science, sleepless nights, countless trials, and a singular mission to transform raw molecules into medicines that heal. The pharmaceutical field is not simply about chemistry. It is a high-stakes pursuit where precision meets purpose, where one decision in a lab can ripple across continents and touch millions of lives.
Yet, behind these quiet revolutions are minds that do more than discover. They refine. They rethink. They reimagine what is possible. Among them stands a scientist whose career has been shaped not only by technical mastery but by a deep sense of responsibility toward making healthcare more accessible, sustainable, and intelligent. With each chapter of his journey, Dr. Madhuresh Kumar Sethi has helped shape the invisible scaffolding that holds modern pharmaceutical progress together.
Composition of Chemistry, Care, and Compliance
“Discovery consists of seeing what everybody has seen and thinking what nobody has thought.” This quote by Nobel Laureate Albert Szent-Györgyi captures the spirit of Dr. Madhuresh Kumar Sethi’s decades-long contribution to pharmaceutical research and development. With a career built on scientific precision, regulatory acumen, and a commitment to accessibility in healthcare, Dr. Sethi has been instrumental in transforming pharmaceutical R&D into a force for global health impact.
Dr. Sethi has dedicated his professional life to shaping the journey of pharmaceutical molecules from discovery to market. With expertise spanning synthetic chemistry, process development, regulatory affairs, intellectual property, nanomedicine, and green chemistry, he has helped pharmaceutical companies create and deliver affordable medicines that meet stringent global standards. His approach has consistently emphasized both scientific rigor and operational efficiency, ensuring that innovation is never divorced from implementation.
Roadmap to Eco-Friendly Synthesis
Dr. Sethi is a contributing author to the insightful chapter titled “Biocatalysis: A Greener Alternative in Synthetic Chemistry” (Chapter 2), published in the Catalysis Series volume Biocatalysis: An Industrial Perspective, edited by Gonzalo de Gonzalo and Pablo Domínguez de María. Co-authored with Purbita Chakraborty and Rohit Shukla, the chapter presents a comprehensive industrial perspective on biocatalysis, with particular emphasis on its application within the pharmaceutical sector.
Published by the Royal Society of Chemistry as part of their 2017 ebook collection, the chapter (DOI: https://doi.org/10.1039/9781782629993-00044) spans pages 44 to 76 and explores the potential of biocatalysis as a sustainable alternative to traditional synthetic methods. Dr. Sethi and his co-authors highlight the advantages and challenges of adopting biocatalytic pathways and stress the need to align existing chemical manufacturing processes with evolving bio-process strategies.
The chapter addresses key elements that constitute an efficient chemical production model and outlines how these can be transformed into more eco-friendly, biocatalytically driven frameworks. It also underscores the necessity of meticulous quality control for biocatalytic products to meet the stringent standards of global pharmaceutical regulatory bodies.
Dr. Sethi’s contribution to this authoritative work reflects his deep expertise in green chemistry and industrial biotechnology. His research supports the transition toward more sustainable practices in pharmaceutical manufacturing and reinforces his role as a thought leader in advancing environmentally responsible innovation within the chemical sciences.
The Road to Research Leadership
Dr. Sethi began his scientific journey in synthetic chemistry, focusing on the design and development of cost-efficient and patent-compliant processes for Active Pharmaceutical Ingredients (APIs). At the beginning of his career, he played a crucial role at JK Industries Ltd, where he specialized in cost-effective, plant-feasible API processes. His work included impurity profiling, technology transfer, and regulatory filing support. He applied early principles of green chemistry and explored polymorphism and nanoparticle formulation techniques, setting a strong foundation for a career that would increasingly blend science with business strategy.
Following this, his tenure at Wockhardt Limited saw him build and lead combinatorial and medicinal chemistry teams focused on drug discovery. He advanced research in Multiple Drug Resistance and led initiatives to develop and patent novel chemical formulations. This phase of his career further honed his skills in early-stage drug development and innovation.
Dr. Sethi’s subsequent experience at Zydus Cadila gave him exposure to biomarker research, IND filings, and pharmacologic testing. He led target validation and contributed to both biotherapeutics and small molecule development, while managing regulatory affairs, product formulation, and intellectual property. Each of these roles allowed him to develop a comprehensive understanding of pharmaceutical research, from ideation to clinical preparation.
At the Helm of a Scientific Evolution
In 2003, Dr. Sethi joined Matrix Laboratories at a time when the Hyderabad-based company was establishing its identity as a global API manufacturer. He became an integral figure in the organization’s transformation into a pharmaceutical leader; honored with the Matrix Achievement Award for successfully defending complex patent litigation, which resulted in significant monetary benefit for the company. Over the next two decades, he contributed to the growth of Matrix and its evolution through acquisitions and restructuring into Mylan Laboratories and later Viatris.
As Head of Chemical Research and Scientific Affairs, Dr. Sethi played a crucial role in guiding the company’s API development, regulatory approvals, and intellectual property strategy. He successfully led numerous programs that resulted in regulatory approvals from the United States Food and Drug Administration and the European Medicines Agency. Under his leadership, Mylan/Viatris and its successors secured first-to-market positions for key generics, including Lansoprazole, Sertraline, Pitavastatin Calcium, and Iron Sucrose, etc. These achievements contributed significantly to the company’s global market expansion.
Dr. Sethi also led the development of iron carbohydrate complexes for intravenous use, which were later approved in the European Union. This work helped bring safer and more effective iron supplementation options to patients, particularly those suffering from chronic illnesses. His contributions extended to injectable drugs and impurity profiling, culminating in regulatory success for products like Glucagon, which received FDA approval in December 2024; Iron Sucrose Injection, USP, an intravenous iron replacement product used to treat iron deficiency anemia (IDA) in Aug 2025.
His work defending Para IV patent litigations also stands out. Through careful strategy and scientific expertise, he helped secure market exclusivity for multiple products, ensuring that intellectual property challenges did not obstruct product launches or patient access.
Engineering Quality That Endures
Dr. Sethi led the development of all products through a comprehensive literature review, structured experimental design, and rigorous analysis, maintained meticulous daily supervision and accurate documentation of all observations in full compliance with legal and data integrity standards. This disciplined approach enabled successful scale-up, sustained commercial manufacturing, and adherence to regulatory standards of the US, EU, Japan, Australia, and other major markets, ensuring consistent quality and successful defense in all litigation matters.
A Track Record of Innovation and Impact
Dr. Sethi has authored and co-authored more than 100+ patents, patent applications, a chapter in a book, and research papers across various domains of pharmaceutical science. His work reflects a deep understanding of both discovery science and its commercial applications. His contributions have enhanced the quality and affordability of pharmaceuticals across multiple therapeutic areas.
Dr. Madhuresh Sethi is a globally recognized pharmaceutical scientist and innovator with a proven record of taking high-value therapeutics, including anti-cancer agents, anti-infectives, GLP-1 receptor agonists for diabetes and weight-loss management, and iron replacement products for iron deficiency anemia (IDA), from discovery to commercial success. His publications and patents reflect the breadth, depth, and real-world impact of his work across multiple therapeutic domains. He combines deep expertise in scalable, sustainable API manufacturing with industry-leading capabilities in Design of Experiments (DoE), flow chemistry, Process Mass Intensity (PMI) optimization, and time cycle improvement to deliver cost-efficient, environmentally responsible, and accelerated product development. Renowned for his leadership in impurity control, genotoxic nitrosamine mitigation, and regulatory compliance, Dr. Sethi has consistently aligned R&D excellence with IP strategy, ESG priorities, and market growth objectives, bringing scientific rigor, governance acumen, and strategic vision to boardrooms, driving health innovation and shareholder value.
Throughout his career, Dr. Sethi has continuously sought new methods to improve the drug development process. He is a strong proponent of integrating green chemistry and biocatalysis into API development to reduce environmental impact and manufacturing costs. He has also contributed to the advancement of asymmetric synthesis and nanomedicine, broadening the technological capabilities of the organizations he has worked with.
At Aurobindo Pharma Ltd, before joining Matrix, Dr. Sethi led teams focused on non-infringing process development for regulated markets. His work included developing synthetic pathways, conducting impurity profiling, and preparing Drug Master Files for submission to global regulatory authorities. He also contributed to shaping the company’s regulatory and patent strategy, which laid the groundwork for its growth in global markets.
Global Engagements in Science, AI & Governance
In 2025, Dr. Sethi demonstrated a strong commitment to staying at the forefront of scientific advancement, regulatory discourse, and industry innovation by actively participating in several high-impact conferences and expert forums across the globe.
He began the year with a notable presence at the Corporate Governance Excellence Summit & Awards 2025, held on January 18. The summit brought together distinguished leaders from government, industry, and international diplomacy. Esteemed dignitaries such as Mr. Suresh Prabhu (former Union Minister, Government of India), Mr. M. Damodaran (former Chairman of SEBI), and a host of ambassadors including H.E. Ms. Jacqueline Mukangira (Rwanda), H.E. Ms. Capaya Rodriguez Gonzalez (Venezuela), H.E. Mr. Fernando Bucheli (Ecuador), and H.E. Mr. Evagoras Vryonides (Cyprus) enriched the event with their global perspectives. The summit was marked by powerful discussions on corporate governance and the celebration of visionary leadership across sectors.
Continuing his engagement with the latest in technology and pharma, Dr. Sethi attended PwC’s Agentic AI Powered Automation session on April 8, followed by the Biomolecule Workshop hosted by ETPharma on April 23, which focused on the future of generic APIs.
In May, he was part of CPHI Americas 2025, the premier pharmaceutical networking event held in Philadelphia from May 21–23, connecting global pharma leaders across the supply chain. The momentum continued in June with the 29th American Peptide Symposium in San Diego, a globally recognized platform showcasing excellence in peptide science, breakthrough research, and international collaboration.
On July 9, Dr. Sethi contributed to critical dialogues on the future of artificial intelligence and shared services at the AI-Driven Transformation Beyond the GCC Roundtable, engaging with peers on the evolving role of AI in reshaping global capability centers.
Looking ahead, Dr. Sethi is scheduled to participate in several strategic events in the latter half of the year. These include ChemOutsourcing 2025 (September 2–5, NJ, USA), a gateway to global pharma connections across the supply chain; the CordenPharma LNP Summit 2025 on September 9 at Boston USA, which focuses on lipid nanoparticles for gene therapy and xRNA development; and the Boulder Peptide Symposium 2025, to be held from September 15–18 in Boulder, Colorado, renowned for its focus on emerging developments in peptide therapeutics.
Through his active involvement in these industry-leading platforms, Dr. Sethi continues to contribute to thought leadership, cross-border collaboration, and innovation in the pharmaceutical and biotech ecosystem.
A Global Voice in Pharma, Policy, and Patent Protection
In addition to his scientific and industrial contributions, Dr. Sethi holds several distinguished roles and affiliations that underscore his global engagement, scholarly expertise, and legal acumen in the pharmaceutical sector:
- APO Expert (Asian Productivity Organization, Japan):
Selected as an international expert for the development of the Active Pharmaceutical Ingredient (API) industry in Bangladesh. This initiative was executed in collaboration with the Bangladesh Productivity Organization and the Bangladesh Society for Pharmaceutical Professionals, aimed at enhancing productivity and innovation in the national pharma sector. - Editorial Responsibilities:
- Editorial Board Member, Der Pharma Chemica
- Editorial Council Member, Archives of Organic and Inorganic Chemical Sciences(Lupine Publishers, USA)
- Professional Memberships in Leading Scientific Societies:
- AmericanChemical Society (ACS)
- ACSDivision of Carbohydrate Chemistry & Chemical Glycobiology ; was.Member, ACS CARB Membership Committee
- ACSChemistry & Law Division
- IndianCouncil of Chemists
- ChemicalResearch Society of India
- IndianPeptide Society
- AmericanPeptide Society
- EuropeanPeptide Society
- ACS ProfessionalRelations Division
- ACS Scholarly Communication Member
- American Association for the Advancement of Science
- AsianPatent Attorneys Association (APAA)
- Board Stewardship
- Expertise in Intellectual Property Rights (IPR):
Sethi has played a pivotal role in numerous high-stakes IPR cases across major global pharmaceutical companies. He has been instrumental in the successful defense of multiple Para IV litigations, pre- and post-grant patent oppositions, and IP strategies for organizations such as Matrix, Mylan, and Viatris. His deep understanding of patent law and regulatory frameworks has made him a key figure in the intersection of pharmaceutical innovation and legal protection.
The Unseen Hand Steering Sustainable Power
In addition to his scientific and regulatory achievements, Dr. Sethi has built a strong reputation as a corporate leader and governance expert. He is a certified Independent Director under the Indian Institute of Corporate Affairs and serves as an advisor on environmental, social, and governance (ESG) practices. His perspective on ESG is informed by years of leading product development with a focus on sustainability, ethical manufacturing, and public health.
Dr. Sethi is also a registered Indian Patent and Design Agent and an active member of the Asian Patent Attorneys Association. He advises pharmaceutical firms on aligning intellectual property protection with research strategy and global business objectives. His work ensures that companies can both innovate responsibly and protect their competitive edge.
Credentials that Bridge the Future
In addition to his academic and professional achievements, he has pursued an extensive range of certifications and specialized training programs across law, technology, leadership, and sustainability. These qualifications reflect his multidisciplinary expertise and commitment to continuous learning:
- Registered Indian Patent and Design Agent
- Postgraduate Diploma in Patent Lawfrom NALSAR University of Law
- Certified Independent Director, recognized by the Indian Institute of Corporate Affairs (IICA)
- Digital Director Certification
- International Corporate Director Certification
- Certified BRSR (Business Responsibility and Sustainability Reporting) Expert
- Certified ESG (Environmental, Social, and Governance) Expert
- Climate Change: The Science and Global Impact– SDGAcademyX
- AI for Beginners– HP
- Gateway to Quantum Computing– Alison
- Technology Entrepreneurship– HarvardX
- Applied Business Analytics– Indian School of Business (ISB) & Emeritus
- Certificate Course on Trademark Law
- Practical Guide on How to File Trademark
- Certificate Course on Geographical Indications
- Certificate Course on Patent Search
- Certificates in Clinical Trials
- Industrial Diploma in Drug Design & Patenting
- Postgraduate Diploma in Business & Corporate Law
- Certificate Program in Cyber Law
- Professional Paralegal Certification
- ISB Certificate Programme in Leadership with AI
- AI for Startups Webinar- Turnip
- How to draft Infringement Notices
- Certificate Course on Electronic Evidences and Cyber Laws
- Crash course on Various Legal Registration
- Turnip’s Independence Day Webinar 2025
This diverse portfolio of certifications underscores his comprehensive understanding of the intersections between science, law, emerging technologies, and responsible corporate leadership.
Blueprints for Ethical Innovation
One of Dr. Sethi’s defining traits is his belief in the role of science as a tool for the public good. His approach to R&D leadership emphasizes knowledge-sharing, regulatory transparency, and the responsible use of intellectual property to support broader access to medication. He maintains a strong belief in mentorship and has guided many young scientists through the nuances of pharmaceutical research, regulatory documentation, and patent law.
A practitioner of methodical thinking and disciplined execution, Dr. Sethi does not view R&D as isolated lab work but as an integrated function that supports patient outcomes, operational success, and market leadership. His ability to communicate across teams, from chemistry labs to boardrooms, has made him a respected leader who can both shape technical strategy and influence corporate direction.
He places a strong emphasis on long-term thinking, consistently advocating for innovations that are scalable, sustainable, and in compliance with both current and anticipated regulatory expectations. His alignment of business objectives with scientific integrity has allowed him to guide pharmaceutical companies through regulatory transitions, patent litigations, and market shifts with clarity and success.
Enduring Legacy in Pharma Leadership
Today, Dr. Sethi continues to contribute to the pharmaceutical industry as an independent advisor, thought leader, and strategic consultant. His work spans both scientific and corporate domains, helping companies bridge gaps between R&D, compliance, and competitive growth.
His focus remains on creating pharmaceutical systems that are efficient, transparent, and geared toward public health impact. He collaborates with regulatory bodies, industry associations, and corporate boards to improve industry standards and ensure that scientific innovation is matched by accessibility and affordability.
With a career that reflects a deep commitment to research excellence, ethical leadership, and business responsibility, Dr. Sethi stands as a key figure in India’s pharmaceutical ecosystem. His legacy is built not only on patents and approvals but also on his consistent drive to use pharmaceutical science for meaningful and measurable human impact.
