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<p>Although India ranks among the largest producers and exporters of human vaccines, the delay in launch of newer therapeutics is larger than the average in G20 nations. This study aims to assess the stakeholders’ perspective on the coherence, clarity, and operational impact of the New Drugs and Clinical Trial (NDCT) Rules 2019. The analysis revealed a nuanced appraisal of the NDCT Rules wherein three major clusters of challenges faced by pharmaceutical companies are regulatory, operational, and systemic. The regulatory barriers encompass prolonged approval timelines, ambiguous legal mechanisms, fragmented oversight across agencies. Operational factors include uneven distribution of trial sites, inadequate site capacity, ethics committee delays. Systemic challenges centred on non-uniform trial protocols, inconsistent documentation practices and absence of harmonized operational guidelines.</p>

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From Clinical Trials to Commercialization: Perspectives in Human Vaccine

  • 期刊论文

  • 发表日期：

    2025年12月10日

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  • Nidhi Mehrotra,
  • Padmavati Manchikanti

摘要

Although India ranks among the largest producers and exporters of human vaccines, the delay in launch of newer therapeutics is larger than the average in G20 nations. This study aims to assess the stakeholders’ perspective on the coherence, clarity, and operational impact of the New Drugs and Clinical Trial (NDCT) Rules 2019. The analysis revealed a nuanced appraisal of the NDCT Rules wherein three major clusters of challenges faced by pharmaceutical companies are regulatory, operational, and systemic. The regulatory barriers encompass prolonged approval timelines, ambiguous legal mechanisms, fragmented oversight across agencies. Operational factors include uneven distribution of trial sites, inadequate site capacity, ethics committee delays. Systemic challenges centred on non-uniform trial protocols, inconsistent documentation practices and absence of harmonized operational guidelines.