Sangita Mishra

@jssuni.edu.in

Rearcher, Department of Pharmaceutics
JSS College of Pharmacy, Mysuru

Sangita Mishra


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https://researchid.co/smishra1990
I have completed my PhD research from JSS College of Pharmacy, Mysuru, India, specializing in Health Policy and Regulatory Sciences. I hold a Masters in Microbiology from Calcutta University. My research focuses on the clinical and regulatory aspects of orphan drugs, with a particular emphasis on global clinical trials, policies, regulations, and therapeutic management.

My research has resulted in two international publications as the first author in the Orphanet Journal of Rare Diseases, exploring orphan drug trials in the EU and rare disease management in India. Additionally, I have co-authored several other publications on orphan drug pricing in the USA, pharmacoepidemiology, and regulatory aspects of therapeutics in various geographies.

My ongoing studies include assessment of cell and gene therapy products usage and effectiveness for rare disease treatment in India and review of ongoing pharmacoepidemiological studies in India to inform health policy planning. I am keen in conti

EDUCATION

MSc, PhD

RESEARCH, TEACHING, or OTHER INTERESTS

Multidisciplinary, Health (social science), Public Health, Environmental and Occupational Health, Pharmaceutical Science
7

Scopus Publications

53

Scholar Citations

3

Scholar h-index

1

Scholar i10-index

Scopus Publications

  • Regulatory Pathway for Genotoxic Impurities in Europe, US, Canada, India, Australia and UK
    Kavyashree Kadehalli Ramegowda, Sangita Mishra, Venkatesh Madhugiri Prakash
    Indian Journal of Pharmaceutical Education and Research, 2026
  • Regulatory Prospects for Stem Cell in Clinical Trials: UAE, US, and India
    Smruti P Reddy, Sangita Mishra, Venkatesh MP
    Current Stem Cell Research and Therapy, 2025
    Introduction: Stem cell therapies are advancing rapidly, requiring robust regulations to ensure safety and ethics. The UAE, with authorities like MOHAP, DOH, DHA, and DHCR, is actively involved in clinical research but faces regulatory inconsistencies across emirates. In contrast, the U.S. (FDA, NIH) and India (CDSCO, ICMR) have unified national frameworks with specific stem cell guidelines. This study compares the UAE's system with those of the U.S. and India to identify strengths and gaps. Methods: A comparative literature review was conducted using regulatory documents, clinical trial registries, peer-reviewed studies, and interviews. The focus was on analyzing the regulatory frameworks in the UAE, the U.S., and India, especially regarding stem cell clinical research. Results: The UAE has established ethical review boards and oversight mechanisms but lacks unified national guidelines and consistent application across emirates. In comparison, the U.S. and India have more cohesive, transparent, and accessible regulatory systems for stem cell research. Discussion: The UAE's efforts in promoting stem cell research are notable, but fragmentation among regulatory authorities hampers coordination. Adopting centralized policies, like in the U.S. and India, could improve efficiency, transparency, and compliance. A national registry and stem cell-specific guidelines are also needed. Conclusion: The UAE has made commendable progress in regulating stem cell clinical research. However, the absence of unified national guidelines and inter-emirate coordination remains a challenge. Learning from the centralized frameworks of the U.S. and India can help bridge these gaps. Strengthening oversight will enhance patient safety, ethical compliance, and global collaboration.
  • Rare disease clinical trials in the European Union: navigating regulatory and clinical challenges
    Sangita Mishra, MP Venkatesh
    Orphanet Journal of Rare Diseases, 2024
    Background Clinical development for orphan drugs presents significant difficulties and challenges. There is no unique or standard design, conduct, and outcome assessment methodology and it is sometimes impractical to fit design models of rare disease trials in any practiced and well-known framework. In the European Union (EU) these challenges encompass a broad array of subjects, including trial design, study outcomes, patient recruitment, trial conduct ethics, trial cost, and chances of success. This literature-based review study aims to provide a thorough overview of the critical aspects of rare disease trials in the EU by analyzing the current landscape of rare disease trials, highlighting key challenges, delving into regulatory and research initiatives and innovation in trial designs, and proposing multi-faceted solutions to implement effective rare disease clinical trials in the region. Discussion Traditional clinical trial designs, validation, and evaluation methodologies used for nonorphan drugs often prove unsuitable for orphan drugs, given the small patient populations, sometimes fewer than 1000 cases. There is an increasing need for accessible therapies and both regulators as well as industry are trying to develop affordable and effective drugs to address this need. Despite several steps that have been taken, the timely development of drugs remains a challenge. One of the reasons behind the long development timeline is the recruitment, retention, and conduct of rare disease trials. To optimize the development timelines of orphan drugs in the EU, it is important to ensure that the safety and efficacy of the product is not compromised. Industry and regulatory agencies must implement innovative trial designs, devise flexible policies, and incorporate real-world data for assessing clinical outcomes. Conclusion Collaboration among academic institutions, pharmaceutical companies (both small and major), patient groups, and health authorities is crucial in overcoming obstacles related to clinical trials and providing assistance and creative ideas. The ultimate objective of granting rare disease patients timely and affordable access to medications with a positive balance between benefits and risks is to be met.
  • Navigating health policies and programs in India: exploring opportunities to improve rare disease management and orphan drug research
    Sangita Mishra, Deepa Bhat, M. P. Venkatesh
    Orphanet Journal of Rare Diseases, 2024
    Background Rare disease (RD) management and orphan drug development in India face various hurdles regarding the implementation and adoption of comprehensive policies, lack of dedicated regulatory frameworks, and absence of epidemiological data. Current rare disease policy focuses more on strengthening the diagnostics and lacks a proper comprehensive treatment framework to ensure favorable clinical outcomes. Indian patients are largely excluded from global orphan drug clinical trials. This further alienates patients from access to rare disease treatment and available treatments come at high cost. This review-based study assesses the landscape of health policies and programs in India through a review of literature and guidelines, to identify strategic opportunities and recommendations for enhancing the overall care and support for the Rare Disease (RD) patient population and improving the orphan drug research ecosystem in India. Discussion The absence of specific regulations, shortage of healthcare resources, budget constraints, competing health priorities, lack of patient data, and insufficient research incentives discourage orphan drug development and global clinical trial inclusion, resulting in treatment inaccessibility and high costs. The Indian Government introduced the National Policy for Treatment of Rare Diseases (NPRD) to address these challenges. Several initiatives have been introduced to attract stakeholders with government-funded research, grants, incentives, and accelerated regulatory approvals of novel therapies that can ensure timely prevention and treatment of rare diseases. The National RD Registry by the Indian Council of Medical Research (ICMR) aims to provide prevalence data. Innovative approaches are required to improve rare disease management and promote orphan drug research. This will ensure the accessibility and affordability of life-saving therapeutics for India’s rare disease patients. Conclusion An integrated RD management and orphan drug research framework focusing on robust data management, patient-oriented policies to improve the treatment landscape, flexible regulations, strengthening rare disease registry with clinical and diagnostic data, and a favorable research ecosystem to promote indigenous research catering to the Indian population, will improve the treatment landscape and orphan drug research and development in India. This will ensure timely availability of therapeutics at affordable prices.
  • Navigating the mammography quality standard act in USA: Role of US FDA and future scopes of regulation
    N.M. Bhumika, Sangita Mishra, M. Arjun, M.P. Venkatesh
    Journal of Medical Imaging and Radiation Sciences, 2024
  • Emerging paradigms in prebiotics research: implications for human health and nutrition
    N Saji, M Arjun, S Mishra, MP Venkatesh
    SA Pharmaceutical Journal, 2024
  • Orphan Drug Pricing and Cost Trends in USA: An Analysis of Impact of Orphan Drug ACT
    Sangita Mishra, Venkatesh Madhugiri Prakash
    Indian Journal of Pharmaceutical Education and Research, 2023
    Abstract: Objectives: The study analyses the impact of incentives in Orphan Drug Act on Orphan Drug revenue strategies of pharmaceutical and biotechnology companies in USA and proposes policies and steps to address the same. Results: There are 389 orphan drugs in circulation as of 2019 with average price of $32,000; prices ranging between $6,000 till more than $500,000. 39% of the marketed drugs costing more than $100,000 treats 23% of patient population. Out of 1.8 million treated patients in 2019, only 0.1% of patients received treatment with drugs having cost greater than $500,000. Orphan drug research and development spending by pharmaceutical and biotechnology companies was 11% of total expenditure of the companies in 2019. The high cost of orphan drugs remains an issue as overall 10% of impacted patient population receiving treatment. Conclusion: The Orphan Drug Act of 1983 has introduced various incentives for pharmaceutical companies to invest more in orphan drug research. It has been observed that there is increase in investment as well as orphan drug approvals because of the incentives and grants. Orphan Drug development is not aligning with the provided incentives and overall cost overall remains high, and availability of treatment is not as expected due to the high costs. Incentives to manufacturers needs to be balanced with treatment availability based on affordable pricing to ensure increased research and higher therapeutic coverage. Keywords: Orphan Drug Act, Orphan drug, Rare Disease, Volume Based Contract, Outcome Based Contract, Value Based Pricing.

RECENT SCHOLAR PUBLICATIONS

  • Exploring Challenges and Opportunities for Improving Phase 2 and Phase 3 Clinical Trials: A Review.
    BAV Sai, S Mishra, MP Venkatesh
    Reviews on Recent Clinical Trials , 2026
    2026
  • Regulatory Pathway for Genotoxic Impurities in Europe, US, Canada, India, Australia and UK.
    KK Ramegowda, S Mishra, VM Prakash
    Indian Journal of Pharmaceutical Education & Research 60 , 2026
    2026
  • Regulatory Prospects for Stem Cell in Clinical Trials: UAE, US, and India
    SP Reddy, S Mishra, V Mp
    Current Stem Cell Research & Therapy , 2025
    2025
  • Brain-computer Interface on Medical Devices: A Promising Technology with Limitless Possibilities
    JS Varughese, M Arjun, S Mishra, MP Venkatesh
    Applied Drug Research, Clinical Trials and Regulatory Affairs 11 (1 … , 2025
    2025
    Citations: 1
  • Navigating the mammography quality standard act in USA: Role of US FDA and future scopes of regulation-A narrative review
    NM Bhumika, S Mishra, M Arjun, MP Venkatesh
    Journal of medical imaging and radiation sciences 55 (4), 101420 , 2024
    2024
    Citations: 4
  • Navigating health policies and programs in India: exploring opportunities to improve rare disease management and orphan drug research
    S Mishra, D Bhat, MP Venkatesh
    Orphanet Journal of Rare Diseases 19 (1), 446 , 2024
    2024
    Citations: 5
  • Rare disease clinical trials in the European Union: navigating regulatory and clinical challenges
    S Mishra, MP Venkatesh
    Orphanet journal of rare diseases 19 (1), 285 , 2024
    2024
    Citations: 35
  • Emerging paradigms in prebiotics research: implications for human health and nutrition
    N Saji, M Arjun, S Mishra, MP Venkatesh
    SA Pharmaceutical Journal 91 (3), 26-37 , 2024
    2024
    Citations: 3
  • REGULATORY PERSPECTIVE FOR GENE THERAPY PRODUCTS IN THE USA, EU AND JAPAN AND FUTURE ASPECTS
    S MISHRA, MP VENKATESH
    Int J Pharm Pharm Sci , 2024
    2024
    Citations: 1
  • Regulatory Challenges and Landscapes of Monoclonal Antibody Registration: Global Outlook
    S MOTILAL, S MISHRA, M Arjun, MP Venkatesh
    Int J Pharm Pharm Sci , 2024
    2024
    Citations: 1
  • Enhancing OTC monograph drug regulation through user fee program.
    C AN, S MISHRA, MP Venkatesh
    Int J Pharm Pharm Sci. 16 (5), 1-6 , 2024
    2024
    Citations: 1
  • Orphan Drug Pricing and Cost Trends in USA: An Analysis of Impact of Orphan Drug ACT
    S Mishra, VM Prakash
    Ind. J. Pharm. Edu. Res 57 (1s), s1-s6 , 2023
    2023
    Citations: 2

MOST CITED SCHOLAR PUBLICATIONS

  • Rare disease clinical trials in the European Union: navigating regulatory and clinical challenges
    S Mishra, MP Venkatesh
    Orphanet journal of rare diseases 19 (1), 285 , 2024
    2024
    Citations: 35
  • Navigating health policies and programs in India: exploring opportunities to improve rare disease management and orphan drug research
    S Mishra, D Bhat, MP Venkatesh
    Orphanet Journal of Rare Diseases 19 (1), 446 , 2024
    2024
    Citations: 5
  • Navigating the mammography quality standard act in USA: Role of US FDA and future scopes of regulation-A narrative review
    NM Bhumika, S Mishra, M Arjun, MP Venkatesh
    Journal of medical imaging and radiation sciences 55 (4), 101420 , 2024
    2024
    Citations: 4
  • Emerging paradigms in prebiotics research: implications for human health and nutrition
    N Saji, M Arjun, S Mishra, MP Venkatesh
    SA Pharmaceutical Journal 91 (3), 26-37 , 2024
    2024
    Citations: 3
  • Orphan Drug Pricing and Cost Trends in USA: An Analysis of Impact of Orphan Drug ACT
    S Mishra, VM Prakash
    Ind. J. Pharm. Edu. Res 57 (1s), s1-s6 , 2023
    2023
    Citations: 2
  • Brain-computer Interface on Medical Devices: A Promising Technology with Limitless Possibilities
    JS Varughese, M Arjun, S Mishra, MP Venkatesh
    Applied Drug Research, Clinical Trials and Regulatory Affairs 11 (1 … , 2025
    2025
    Citations: 1
  • REGULATORY PERSPECTIVE FOR GENE THERAPY PRODUCTS IN THE USA, EU AND JAPAN AND FUTURE ASPECTS
    S MISHRA, MP VENKATESH
    Int J Pharm Pharm Sci , 2024
    2024
    Citations: 1
  • Regulatory Challenges and Landscapes of Monoclonal Antibody Registration: Global Outlook
    S MOTILAL, S MISHRA, M Arjun, MP Venkatesh
    Int J Pharm Pharm Sci , 2024
    2024
    Citations: 1
  • Enhancing OTC monograph drug regulation through user fee program.
    C AN, S MISHRA, MP Venkatesh
    Int J Pharm Pharm Sci. 16 (5), 1-6 , 2024
    2024
    Citations: 1
  • Exploring Challenges and Opportunities for Improving Phase 2 and Phase 3 Clinical Trials: A Review.
    BAV Sai, S Mishra, MP Venkatesh
    Reviews on Recent Clinical Trials , 2026
    2026
  • Regulatory Pathway for Genotoxic Impurities in Europe, US, Canada, India, Australia and UK.
    KK Ramegowda, S Mishra, VM Prakash
    Indian Journal of Pharmaceutical Education & Research 60 , 2026
    2026
  • Regulatory Prospects for Stem Cell in Clinical Trials: UAE, US, and India
    SP Reddy, S Mishra, V Mp
    Current Stem Cell Research & Therapy , 2025
    2025