Abstract
This short critique aims to share the evolving regulatory environment and compliance challenges that innovators, nanotechnologists, and public health enthusiasts in India ought to keep in mind before hopping on the bandwagon of innovative point-of-care diagnostic devices in the primary healthcare space. More significantly, the priority-setting approach suggested by the authors needs to be adapted through iterative practice and refinement in order to identify innovative point-of-care diagnostic devices that can eventually raise the quality and cost-effectiveness of healthcare provisions at the last-mile.
Highlights
In October 2018, 197 countries around the world ratified the Declaration of Astana
sustainable development goals (SDG) 3 calls for health and well-being across all age groups by addressing priority areas such as maternal and child mortality, communicable diseases, non-communicable diseases and mental health, and healthcare workforce
The unclear regulatory environment with numerous grey areas concerning introduction and commercialization of new innovative point-of-care diagnostic medical devices confounds the situation. This short critique aims to share the evolving regulatory environment and compliance challenges that innovator, nanotechnologists, and public health enthusiasts in India ought to keep in mind before hopping on the bandwagon of innovative point-of-care diagnostic devices in the primary healthcare space
Summary
Getting on the Bandwagon of Innovative Point-of-Care Diagnostic Devices to Boost Primary Healthcare in India: A Short Critique and Way Forward. Arvind Vashishta Rinkoo*, Anand Kumar Panjiyar, Arnika Sharma, Dinesh Songara, Rajesh Ranjan Singh, Dipanjan Sujit Roy, Rakesh Kumar Srivastava
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