Critical pathway for new tb diagnostics
Asia: Enablers
and Barriers
India
Enablers
Standardised protocols for independent evaluation
Easy online access to ICMR portal
Multiple innovation hubs and technology incubators
Transparency of validation results
Regular ICMR-CDSCO workshops.
Various governmental initiatives for new manufacturers
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Barriers
Infrequent NTEG meeting
Availability and Clarity of CDSCO protocol
No assessment standards for AI-based tools
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Bangladesh
Enablers
Recommendations from WHO, FDA, CE
ISO certifications
Supporting data from other high-burden countries
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Barriers
Dependent on donor support
Substantially long duration to incorporate into the National TB Program
Limited role of private sectors in TB diagnosis
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Pakistan
Enablers
GF-WHO partnership and recommendation
Political patronage
Use DNO to locate sites for new platforms not covered by Xpert
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Barriers
Manufacturers’ reluctance to invest in certifications
Political instability is affecting CMU/ NTP leadership and retention
Limited program capacity for DNO/ change/ expansions
The DRAP application is not entirely online
Indonesia
Enablers
Revision of the standard protocol for independent evaluation
GF-WHO partnership and recommendation
MoH Policy/Program of the Indonesian government
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Barriers
Guideline on clinical validation and HTA sandbox under development
Pre-market validation may be delayed by limited standardized labs
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Africa: Enablers and Barriers
Ethiopia
Enablers​
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EFDA participation in WHO CRP enables accelerated IVD registration
Regulatory reliance on regional and SRA approvals speeds review
Local evidence and pilot data facilitate rapid policy inclusion
Training, advocacy, and PPPs drive demand for new TB diagnostics
Digital connectivity and NEDL guide optimized diagnostic placement
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Barriers
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Limited local capacity and overlapping regulatory initiatives cause delays in product registration
TB diagnostics are not yet covered under AMA/AMRH or Africa CDC joint review mechanisms
Funding shortages, capacity gaps, and outdated regulatory frameworks slow approvals and validation
Low awareness, TB stigma, and private sector exclusion from CBHI hinder demand and financing
Systemic constraints, including supply chain issues, staff shortages, and infrastructure gaps limit scale-up of new TB diagnostics
South Africa
Enablers​
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SAHPRA’s reliance review and WHO PQ/GTB guidance
Regional collaboration (Zazibona, AMA/AMRH, Africa CDC) supports harmonized market entry
Local evidence generation by NHLS, academia, and WHO PQ labs
Active civil society and funder support
Transparent and pooled pricing mechanisms
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Barriers
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Overlapping regulatory initiatives and limited local capacity cause delays in approvals and harmonization
AMA/AMRH scope gaps and pending AMA ratification limit continental alignment for TB diagnostics
SAHPRA and HTA misalignment, unclear processes, and resource constraints slow policy inclusion and evidence review
Low awareness, limited training, and weak community engagement hinder uptake and guideline adherence.
Funding shortages, high operational costs, and reduced donor support restrict rollout and sustainability of new TB diagnostics.
Gabon
Coming soon!
Kenya
Enablers​​
WHO PQ not required but enables expedited review
Complete PRIMS submissions speed processing
Clear post-approval pathways for policy inclusion
NTP considering POC tests at primary care
External funder commitment supports adoption
Relatively quick procurement processes
Collaboration with manufacturers for sustainable connectivity
Country conducts DNOs/DNAs every two years
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Barriers​
Resource-intensive post-market surveillance is required
PPB needs more IVD capacity/skills
WHO PQ needed for national policy adoption
Operational buy-in for lay testers
Procurement length depends on resources, contract complexity, and coordination
Funding constraints from geopolitics and reduced external funding.
DNOs and connectivity introduced via USAID, leading to future financing uncertainty
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