Dr. Vijay Bagul: Senior General Manager at Medley Pharmaceuticals Limited, India
Title/Designation: Dr. Vijay Bagul
Current Role/Designation: Senior General Manager
Organization/Institution: Medley Pharmaceuticals Limited
Country: India
Subject Track: Chemistry
Key Areas of Expertise: Senior Professional in Analytical Research & Development (Formulation – Solid Dosage, Liquid, Ophthalmic & Suspension Forms)
Award Category: Best Researcher Award
Submitted: October 1, 2025
Mr. Vijay Arjun Bagul is a senior pharmaceutical industry professional with over 23 years of hands-on and strategic leadership experience in Analytical Research and Development (AR&D). He specializes in the development, validation, and regulatory compliance of analytical methods for a wide range of dosage forms including solid oral, liquid, ophthalmic, and suspension formulations. Currently serving as Senior General Manager and Head of ADL at Medley Pharmaceuticals Ltd., he leads cross-functional teams supporting US, UK, EU, Russia, and domestic regulatory markets. Known for his deep technical expertise, regulatory insight, and leadership capabilities, Mr. Bagul has played a critical role in numerous ANDA filings and successful inspections by agencies such as USFDA and WHO. He is also actively engaged in mentoring, scientific training, and operational excellence in a regulated R&D environment.
Online Profiles
Education
Mr. Bagul holds a Master of Science (M.Sc.) degree in Inorganic Chemistry from the University of Mumbai, which laid the foundation for his career in pharmaceutical analysis. Currently, he is pursuing his Ph.D. in Science at the Institute of Science, Dr. Homi Bhabha State University, Mumbai, with a research focus on stability-indicating methods and impurity profiling. His undergraduate studies in Chemistry were also completed at the University of Mumbai. He has a strong academic background with consistent focus on applied analytical chemistry and pharmaceutical sciences, which has greatly enriched his industry contributions and research publications.
Research Focus
His primary research areas include analytical method development and validation, stability testing, dissolution studies, degradation product profiling, and reverse engineering of reference listed drugs (RLDs). He is particularly focused on advanced chromatographic techniques like HPLC, GC, LC-MS/MS, and stability-indicating method development for complex formulations. In recent years, he has emphasized regulatory-oriented research in genotoxic impurities, nitrosamine detection, and green chemistry approaches. His work bridges academic rigor with practical pharmaceutical application, ensuring regulatory compliance while advancing scientific understanding.
Experience
Mr. Bagul’s career spans over two decades across leading pharmaceutical companies including Wockhardt Ltd., Torrent Pharmaceuticals, Alembic Pharmaceuticals, Ajanta Pharma, and currently, Medley Pharmaceuticals Ltd. Since 2018, he has been serving as the Head of Analytical Development Laboratory (ADL), overseeing a team of more than 150 scientists. He has successfully managed numerous regulatory submissions and technology transfer projects for US, UK, Europe, Russia, and ROW markets. His experience includes budgeting, CAPEX planning, vendor qualification, method troubleshooting, and regulatory inspections. His collaborative leadership style and scientific depth have positioned him as a key figure in India’s formulation AR&D landscape.
Research Timeline & Activities
Mr. Bagul’s research journey began in the early 2000s with his first publication in 2003. Over the past two decades, he has authored and co-authored multiple peer-reviewed articles, contributing to innovations in HPLC, UV spectroscopy, and impurity analysis. His research activities intensified from 2021 onwards with a surge in collaborative works on stability-indicating methods, simultaneous drug estimation, and LC-MS/MS methodologies. He actively engages in institutional partnerships, advisory roles, viva-voce examinations, and IQAC committees. His participation in academic-industry collaborations ensures that his research remains cutting-edge, relevant, and aligned with global regulatory expectations.
Awards & Honors
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Appointed as Member of Internal Quality Assurance Cell (IQAC) at Thakur College of Science and Commerce (Autonomous) from Academic Year 2022–2023 as a Nominee from Industry.
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Appointed as Research Advisory Board Member at H.K. College of Pharmacy, Mumbai (2018–2020).
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Invited as an External Expert for Viva-Voce and Interactive Guest Talks at leading pharmaceutical education institutes like NMIMS (Shirpur Campus), H.R. Patel Institute, and C.U. Shah College of Pharmacy, Mumbai.
These roles highlight his recognition as an industry-academic interface, valued for his deep expertise and ability to guide young researchers and students in formulation science and regulatory research.
Top Noted Publication
Among his many contributions to scientific literature, one of Mr. Bagul’s top-cited works is the LC-MS/MS Method for Identification & Quantification of Varenicline Nitroso Impurities using the QTRAP 4500 Mass Detector. This paper, published in the International Journal of Pharmaceutical Sciences and Nanotechnology (IJPSN) in 2025, addresses a critical regulatory concern related to nitrosamine impurities in pharmaceutical products. The work is a benchmark in applying high-end instrumentation for impurity profiling and serves as a valuable reference for regulatory submissions and analytical laboratories.
DOI: https://doi.org/10.37285/ijpsn.2025.18.2.7
One of Mr. Vijay A. Bagul’s most recent and noteworthy publications is titled “A Suitable Chromatographic Method for Simultaneous Estimation of Brimonidine and Brinzolamide in Glaucoma Treated Dosage Form: Influence of its Greenness with Use of Green Metric Tools,” published in the Oriental Journal of Chemistry on June 26, 2025. This study focuses on the development of an eco-friendly, robust RP-HPLC method for the simultaneous estimation of two ophthalmic drugs—Brimonidine and Brinzolamide. The novelty of the work lies in its integration of green analytical chemistry principles, evaluated using multiple green metric tools, ensuring sustainability without compromising method performance. This contribution reflects a growing commitment to environmentally conscious analytical practices.
DOI: 10.13005/ojc/410304
Contributors: Harmeet Kaur Kohli, Satish K. Ghumare, Deepa D. Parab, Vijay A. Bagul