‘It feels incredibly rewarding, and I am genuinely proud of this achievement’

Harsh Sah has completed his post-graduation from the School of Biosciences (SBS) at Apeejay Stya University (ASU), Gurugram, earning his M.Tech in Biotechnology with distinction. He recently came up with a research publication in the journal of applied laboratory medicine by the Oxford University Press, which is one of the most renowned and reputed scientific journals. In this interview, he shares about his focus for the research paper and more. Read edited excerpts:   

Please tell us about your recent research
My recent research work, entitled “Regulatory Framework for In Vitro Diagnostic Devices in India: Current Landscape, Challenges, and Future Perspectives”, is a review article published in The Journal of Applied Laboratory Medicine by The Oxford University Press. It examines India’s IVD regulatory landscape with a detailed focus on device classification, approval pathways, quality management requirements, and post-market mechanisms. The study also highlights major challenges, including enforcement gaps, inconsistent compliance among small and medium-sized enterprises, limited adoption of harmonized standards, weak post-market surveillance, and the lack of transparent public databases. A comparative analysis also reveals areas where India falls short compared to European and US frameworks, especially regarding mandatory clinical evidence, structured post-market surveillance, and stakeholder engagement.

What was the focus?
Our primary focus was to create meaningful value for regulators, policymakers, manufacturers, and clinicians in India’s diagnostic sector. By examining enforcement gaps, a weak post-market surveillance system, and the limited adoption of international standards, the review provides clarity on how these issues directly impact diagnostic reliability, patient safety, and the overall credibility of the regulatory system.

How do you feel about publishing this?
It feels incredibly rewarding, and I am genuinely proud of this achievement. I am deeply thankful to my co-authors from SCTIMST, whose guidance, support, and shared dedication made this publication possible. This work reflects months of hard work, countless discussions, and a commitment to contribute meaningfully to India’s diagnostic ecosystem. Seeing it published in such a reputable journal is both humbling and motivating, and it inspires me to continue pursuing impactful research in this field.

How many research works have you published so far?
I have published four research articles so far, all in internationally renowned journals. Publications in the field of medical device regulatory affairs are quite rare, and even rarer when focused specifically on India. This gives me a unique edge, as two of my publications are on highly reputed platforms like IEEE and Oxford University Press. I also have several more manuscripts in the pipeline, particularly focused on MedTech and regulatory frameworks at both international and national levels.

Why did you choose this topic?
That is a truly heartfelt question. I am well aware of the number of papers or articles published every day, but what truly makes this work so special is that it delves into an area that has been rarely explored, the intersection of IVD, Regulation, and the Indian landscape. The availability of credible and comprehensive resources in this niche was so limited that what started as a challenge soon became a dare. But ultimately, it was a team effort of passionate regulatory professionals who accepted it and turned that dare into a milestone. This publication holds immense significance for the emerging IVD market in India and for those who wish to understand, explore, and contribute to the regulatory framework shaping the future of diagnostics in our country.

If anyone wishes to access or cite this article, please follow the citation given below. The article is also easily traceable via PubMed, Google Scholar, and the official journal library.
Ramesh, M., and Sah, H. Regulatory Framework for In Vitro Diagnostic Devices in India: Current Landscape, Challenges, and Future Perspectives. The Journal of Applied Laboratory Medicine. https://doi.org/10.1093/jalm/jfaf164