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<p>Microphysiological systems (MPS) have enabled a paradigm shift from reliance on animals to human-relevant tools for drug development. Following progressive regulations by USA, Europe, Canada, and other nations, India authorized the use of MPS in its New Drugs and Clinical Trials Rules (Amendment) 2023. However, while the use of these models by the pharmaceutical industry has been documented globally, this information is sorely lacking among developing nations such as India. We uncovered that embracing MPS in the Indian community is challenged by multiple factors. To actively participate in the global shift toward human-centric biomedical research, India must enhance its MPS awareness, skill development, regulatory guidelines, local resource availability, and return on investments. We found that there is a significant diversity in the costs of different MPS in India and provide recommendations to manage their expenses in the context of low-income nations. In conclusion, our findings will hasten MPS adoption, limit archaic animal use, help in formulation of institute policies, and shape the country’s investment in contemporary science.</p>

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Pharmaceutical adoption of microphysiological systems in India is contingent on their economics among other aspects

  • 期刊论文

  • 发表日期：

    2025年5月15日

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  • Kasturi Mahadik,
  • Surat Parvatam,
  • Nalam Madhusudhana Rao

摘要

Microphysiological systems (MPS) have enabled a paradigm shift from reliance on animals to human-relevant tools for drug development. Following progressive regulations by USA, Europe, Canada, and other nations, India authorized the use of MPS in its New Drugs and Clinical Trials Rules (Amendment) 2023. However, while the use of these models by the pharmaceutical industry has been documented globally, this information is sorely lacking among developing nations such as India. We uncovered that embracing MPS in the Indian community is challenged by multiple factors. To actively participate in the global shift toward human-centric biomedical research, India must enhance its MPS awareness, skill development, regulatory guidelines, local resource availability, and return on investments. We found that there is a significant diversity in the costs of different MPS in India and provide recommendations to manage their expenses in the context of low-income nations. In conclusion, our findings will hasten MPS adoption, limit archaic animal use, help in formulation of institute policies, and shape the country’s investment in contemporary science.