Dr. Neeraj Kumar | Good Society for Ethical Research
“If you consistently prioritize patient needs and focus on finding practical solutions, you’ll build a rewarding career and make a real difference in the quality of healthcare.”
Dr. Neeraj Kumar, who is a seasoned clinical research and regulatory affairs professional with over 15 years of experience in the clinical research, pharmaceutical and medical device industry and currently serving as the Member Secretary of the Good Society for Ethical Research (GSER) and is also associated with Datt Mediproducts Pvt. Ltd, Delhi (a Medical device company at Delhi) as Sr General Manager – Clinical Operations, The Indian Pharmaceutical Association—Delhi State Branch (IPA-DSB) as Vice President, Society for Research Welfare, Delhi (SRW) as Chairman; Delhi Pharmacy Trust (DPT) as Trustee and Human Ethics Committee Association (HECA) as Executive Committee Member and Association of Regulatory Affairs Professional (ARAP) as Governing Member, joined the team of Prime Insights Magazine for an interview. With over 15 years of experience in clinical research, regulatory affairs, and ethical compliance, his sheer focus has been on enhancing the quality and integrity of healthcare research in India.
He has previously associated with esteemed organizations such as INMAS-DRDO, Dr. Reddy’s Laboratories, Pharmazz India, Arbro Pharmaceuticals, Auriga Research, and Translumina Therapeutics. He is also active member of professional bodies like the Indian Pharmaceutical Association (IOPA), Association of Pharmaceutical Teachers of India. (APTI), Society of Nuclear Medicine India (SNMI) and Delhi Pharmacy Council (DPC). He is also a Certified GCP Professional (CDSA) and ISO 13485:2016 Lead Auditor, Dr. Neeraj holds five Indian patents and has authored numerous research papers in national and international journals.
Talking about his organization, GSER is an independent, nonprofit organization committed to upholding ethical standards in clinical and biomedical research. Accredited by the National Accreditation Board for Hospitals & Healthcare Providers (NABH) and registered with the Central Drugs Standard Control Organisation (CDSCO) as an independent ethics committee, GSER plays a vital role in safeguarding the rights, safety, and well-being of clinical research participants. It operates under the chairmanship of Dr. Roop Krishen Khar, Director at B.S. Anangpuria Educational Institutions, Faridabad, Haryana. A distinguished academician and former Dean of Jamia Hamdard, Dr. Khar has guided 86 Ph.D. scholars, published over 350 research papers, and holds 17 patents. With over five decades of excellence in pharmaceutical education and research, he is a visionary leader in the domain of ethical clinical research.
The organization’s mission is to improve ethical research practices by serving as a resource for ethics education, professionalism, and compassionate communication in clinical research. In the context of healthcare accreditation, GSER plays a crucial role by offering end-to-end consultancy for NABH accreditation, including training and implementation support. Their standardized, SOP-driven processes and commitment to continuous improvement make us a trusted partner for institutions aiming to uphold the highest standards of ethical research and patient care.
Well, that was just a brief introduction about the visionary and his brainchild in the limelight, and moving forward, we have crafted this editorial that will give our readers a detailed overview of the conversation we had with Dr. Neeraj Kumar.
We are glad to feature his story under the edition “The 10 Most Influential NABH Consultants Ensuring Healthcare Excellence in 2025”.
Prime Insights: We welcome you, sir. It’s a pleasure to have you joining us. To begin with, could you tell us what motivated you to specialize in NABH consulting and how your journey in this niche began?
My journey into NABH consulting was a natural evolution of my professional engagement in clinical research, regulatory strategy, and ethical oversight. Over the past 15+ years, I have worked extensively in areas (pharmaceutical companies/medical device industry and independent consultant for clinical research at various phases) that intersect with patient safety, ethical research conduct, and healthcare quality—each of which is integral to the NABH accreditation framework.
A pivotal moment in this journey was my involvement as an external expert during the drafting of The Medical Device Rules, 2017 and The New Drugs and Clinical Trial Rules, 2019, issued by the Central Drugs Standard Control Organization (CDSCO). I had the privilege of contributing to these landmark regulatory policies as a representative of the Indian Pharmaceutical Association This experience offered deep insights into the practical challenges faced by the clinical research industry and the need for systemic improvements aligned with accreditation standards.
In my role as Member Secretary of the NABH-accredited Good Society for Ethical Research (GSER), I have worked closely with clinical investigators, clinical research organizations, and healthcare organizations to review research protocols, ensure regulatory compliance, and develop SOPs aligned with Good Clinical Practice (GCP). These engagements exposed the critical role NABH accreditation plays in raising the bar for quality, safety, and accountability in healthcare and research environments.
Today, I continue to support healthcare and research institutions on their path to NABH accreditation, driven by a passion for strengthening India’s healthcare infrastructure through ethical, regulatory, and quality excellence.
Prime Insights: In what ways has your consulting practice elevated healthcare quality standards in India? Could you share a notable success story?
As a regulatory affairs and clinical research professional with over 15 years of experience, my consulting efforts have been directed toward strengthening institutional systems and aligning healthcare and research practices with national and international quality standards. This includes supporting NABH accreditation, ethical research governance, GCP compliance, and regulatory capacity building.
One of the most impactful initiatives I have led is through my role as Member Secretary of the NABH-accredited Good Society for Ethical Research (GSER). Under my leadership, GSER implemented a structured, SOP-driven ethics review system that promotes compliance, transparency, and participant protection in clinical research. A key innovation has been the introduction of half-yearly self-assessments and organizational workflow evaluations by team members, which help identify practical gaps and drive continuous quality improvement. These internal reviews have been instrumental in refining our operational processes and have become a benchmark for other ethics committees.
A particularly notable success was our support to several Institutional Ethics Committees (IECs) across India in meeting NABH standards and strengthening ethical governance. Through GSER, we conducted comprehensive gap assessments, developed customized SOPs, and organized capacity-building training programs for IEC members and administrators. Notable institutions that benefited from these initiatives include the Institutional Ethics Committee of Jamia Hamdard, the Institute of Nuclear Medicine and Allied Sciences (INMAS), the Defence Institute of Physiology & Allied Sciences (DIPAS), and Dr. Harisingh Gour Vishwavidyalaya (Sagar University).
Following our interventions, these committees demonstrated measurable improvements in ethical review quality, documentation practices, and compliance with regulatory and NABH guidelines. Their progress now serves as a model for other ethics committees aspiring for accreditation and excellence in research oversight.
Prime Insights: How do you differentiate your services from other NABH consultants in terms of value, results, or methodology?
My approach is a deep-rooted integration of regulatory expertise, ethical governance, and hands-on institutional development. Rather than offering one-size-fits-all solutions, I focus on customizing strategies that align with the unique structure, challenges, and goals of each organization—whether it’s an ethics committee or a research institute, etc.
My services go beyond documentation and compliance checklists. I prioritize capacity building through structured training, stakeholder engagement, and ongoing mentoring. For example, I emphasize internal self-assessment mechanisms and team-based evaluations, which not only support NABH requirements but also cultivate a culture of continuous quality improvement. This results in sustainable change, not just short-term accreditation.
Additionally, my background as a contributor to national regulatory frameworks—such as the Medical Device Rules, 2017 and NDCTR 2019—enables me to provide insights that are aligned with both policy and practice. This dual lens allows me to bridge compliance with practical implementation effectively, a distinction that clients repeatedly find valuable.
Ultimately, my goal is to empower institutions to internalize quality systems so that NABH accreditation becomes a natural outcome of operational excellence, not just a milestone to check off.
Prime Insights: What strategies do you use to build trust and long-term relationships with your healthcare clients?
In a regulatory environment as dynamic as healthcare accreditation, I adopt a proactive and integrative strategy to stay aligned with NABH’s evolving standards—particularly those affecting Ethics Committees, as detailed in the latest NABH “Assessment Criteria for Ethics Committee” document.
Rather than simply reacting to updates, I engage with NABH’s ecosystem by following circulars, participating in stakeholder consultations, and reviewing policy papers and assessment protocols as soon as they are released. My role as a domain expert and my association with Good Society for Ethical Research (GSER) also place me at the intersection of academic, ethical, and regulatory perspectives—helping me anticipate shifts in standards before they are fully implemented.
This foresight is translated into actionable guidance for clients. For example, I help ethics committees and research institutions not only comply with current NABH expectations but also prepare for upcoming audit trends. I focus on strategic preparedness—guiding clients to embed quality systems that are scalable, audit-resilient, and aligned with both Indian regulations and international best practices.
Prime Insights: How do you ensure that hospitals and clinics not only achieve NABH certification but also sustain compliance and quality culture over time?
NABH accreditation is a milestone, not the finish line—sustaining it demands embedding quality into an organization’s culture. My approach focuses on fostering system ownership, team accountability, and robust, long-term processes rather than mere checklist adherence.
I start by training multidisciplinary hospital or clinic teams to internalize NABH standards, making quality and patient safety integral to daily operations. I implement internal audit systems, encourage biannual departmental self-assessments, and guide leadership in leveraging quality indicators and audit outcomes for ongoing improvement.
We also support the establishment or enhancement of Quality & Safety Committees, promote a strong documentation culture, and advocate for data-driven decision-making. By integrating patient and staff feedback loops through surveys, I enable continuous learning and adaptive improvements.
Through ongoing mentorship, post-certification support, and alignment with NABH and CDSCO ethical and regulatory standards, I empower organizations to transition from compliance-focused to quality-centric operations.
Prime Insights: What is your vision for the future of healthcare accreditation in India, and how do you see your role shaping that vision?
In my view, the future of healthcare accreditation in India is headed toward a transformative shift. It’s no longer just about ticking boxes or meeting regulatory requirements; it’s about creating a healthcare ecosystem that truly prioritizes patient-centric care and measurable quality outcomes. As we move forward, I see technology playing a central role in this transformation.
Technology integration will be key. I envision accreditation processes becoming more seamless and efficient, powered by digital tools and data analytics, routinely monitoring real-time compliance, streamlining audits, and bringing about greater transparency in healthcare operations. With these advancements, accreditation will evolve from a periodic check into an ongoing process of quality assurance.
At the same time, patient-centric care will take the spotlight. Accreditation will be a reflection of how well healthcare providers improve patient safety, satisfaction, and overall health outcomes. It will become a true indicator of excellence rather than just a regulatory checklist. I believe this shift will redefine healthcare quality standards, making them more relevant and impactful.
Sustainability and ethical care delivery will also become significant pillars. The healthcare landscape will increasingly align with broader societal goals, encouraging practices that are not only sustainable but also ethical, ensuring the well-being of both patients and the environment.
In terms of my role as an NABH consultant, I see myself as an active driver of these changes. I aim to help healthcare providers adopt innovative digital frameworks that ensure continuous quality monitoring and streamline the accreditation process. By fostering a culture of excellence, I encourage facilities to aim beyond just meeting NABH standards and focus on outcome-driven care that enhances patient experiences.
In addition, I want to be an advocate for evolving accreditation standards. By working with hospitals and healthcare providers, I push for criteria that are patient-centric, ethically grounded, and focused on long-term quality improvements. It’s about shaping a future where healthcare accreditation reflects not just compliance, but a genuine commitment to delivering exceptional, sustainable, and patient-first healthcare.
In short, I see my role as bridging the gap between today’s healthcare systems and the future we are striving for—one where accreditation is a mark of true excellence in care.
Prime Insights: Looking ahead, what are your key goals or initiatives for 2025 and beyond in your mission to promote healthcare excellence?
Looking ahead to 2025 and beyond, my mission to promote healthcare excellence is guided by a deep commitment to equity, innovation, and patient-centered care. I believe quality should be accessible, measurable, and meaningful—not just a checklist, but a lived experience for every patient and provider.
Expanding Digital Transformation: I’m focused on scaling smart compliance tools—like real-time dashboards, automated internal audits, and digital feedback systems—that allow hospitals to stay continuously audit-ready. These tools don’t just improve efficiency; they foster a culture where data drives decisions and quality becomes second nature.
Capacity Building and Workforce Training: Empowering people is at the heart of sustainable quality. I plan to roll out structured training programs—blending in-person workshops and e-learning—tailored to different roles in healthcare settings. From quality champions to frontline staff, everyone should feel confident and capable in delivering safe, effective care.
Reaching Underserved Regions: A key priority is extending NABH consultancy and quality improvement support to smaller private hospitals’ ethics committees or ethics committees of government hospitals in Tier 2 and Tier 3 cities. Many of these facilities are eager to improve but lack access to resources. My aim is to bridge that gap and ensure no region is left behind in the journey toward excellence.
Strengthening Ethics and Regulatory Alignment: With evolving frameworks like DHR’s and CDSCO Ethics Committee registration, I continue to help institutions stay compliant, transparent, and ethically sound. This reinforces public trust and safeguards patient rights—a non-negotiable aspect of quality care.
Developing Targeted Quality Improvement Collaboratives: We’ll be launching collaborative tasks on awareness in high-impact areas like reducing hospital-acquired infections or improving stroke pathways. By working together, hospitals can rapidly test, refine, and scale solutions in real time.
Integrating Sustainability into Quality Frameworks: Healthcare excellence must include environmental responsibility. That’s why we’re integrating sustainability metrics—such as waste reduction and energy efficiency—into our assessment of quality, which has a main focus on the use of solar energy and green workflow. After all, protecting human health means protecting the planet too.
Plotting Next-Generation Audit Methodologies: We’re exploring smarter audit models—risk-based, tech-enabled, and hybrid approaches—that reduce administrative burden while maintaining rigor.
Enhancing Public Awareness and Patient Engagement: I believe that informed patients are essential partners in quality care. We plan to launch awareness initiatives to help people understand what accreditation means and how they can advocate for safer, better care. Quality isn’t just about systems—it’s about people.
