Country-Specific Critical Path | TB Diagnostics Critical Pathway Analysis

Country-Specific Critical Path Analysis

We mapped the critical pathways that new tuberculosis diagnostics follow in nine countries, from regulatory approval through integration into national TB programs. This work provides a detailed pathway for introducing new TB diagnostic tests in these 9 countries, identifying key gaps, enablers, barriers, and recommendations for a faster and streamlined path to introducing new TB tests

India

New diagnostics in India must receive CDSCO approval, followed by ICMR validation. Results are published and reviewed by the Central TB Division (CTD), which conducts further assessments on cost-effectiveness and feasibility before recommending national roll-out. While local manufacturers are prioritised, imported technologies can also follow this pathway. Learn more here:

Bangladesh

New TB diagnostics in Bangladesh are adopted primarily through the public sector, with NTP approval taking 3–6 years via a multi-step process involving the National TB Technical Committee. DGDA oversees import approvals, relying on WHO prequalification, FDA/ISO certification, and use in other high-burden countries. Learn more here:

Bangladesh Specific Critical Path
Full country report
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Pakistan

In Pakistan, public sector TB diagnostics rely heavily on GFATM funding and donations. Key steps include GFATM funding approval, GDF product availability, and NTP willingness to adopt. Fast-track adoption is enabled by WHO/GFATM support, parallel pilots, and demand creation. Learn more here:

Indonesia

Since January 2025, Indonesia has focused on two key processes: pre-market clinical validation and HTA review. While HTA emphasises treatment and digital tools, lab-based validation is now required for distribution permits, ensuring only rigorously vetted products reach NTP consideration. Learn more here:

Ethiopia

The CPA for Ethiopia outlines the regulatory, policy, implementation, and market-entry steps to accelerate adoption of next-generation TB diagnostics. Key enablers include regulatory initiatives, local validation capacity, advocacy platforms, and procurement systems. Strengthening EFDA, streamlining policy processes, engaging manufacturers, and ensuring sustainable funding are essential to scaling up diagnostics at the primary care level, with an estimated annual need of 4.38 million tests. Learn more here:

Kenya

In Kenya, new TB diagnostics require PPB approval, with WHO endorsement easing the process, while NTLD-P leads policy adoption. Near POC tools and mobile units are prioritized for active case finding and training. Key challenges include complex regulation, donor dependence, and limited private sector capacity. Pricing must fit NTLD-P budgets, with partial coverage under national insurance. Procurement relies mainly on Global Fund, USAID, and GDF, with integration efforts underway but sustainability uncertain. Learn more here:

South Africa

In South Africa, new TB diagnostics are approved through SAHPRA, with WHO prequalification and ZAZIBONA easing registration, while NTLP and NDoH guide policy adoption. Near POC molecular and LAM tests are prioritized for primary care and community use. Procurement and pricing are managed through NHLS and NHI, with partial donor support from USAID and the Global Fund. Digital systems and strong research institutions support integration. Learn more here:

Gabon

New TB diagnostics in Gabon require WHO endorsement or ANMAPS approval within the CEMAC regional framework, with policy adoption led by PNLT and WHO taking 6 months to 2 years. Priority tools include near POC molecular and next-generation LAM tests to replace microscopy and expand access at primary care. Integration efforts such as geo-mapping and iqLIS deployment are underway, but sustainability remains a concern in Gabon’s small market. Learn more here:

Gabon Specific Critical Path
Full country report

Nigeria

Update coming soon!