Trends of Malaria Cases and Deaths

Therapeutic Efficacy Studies (TES) serve as methodical clinical evaluations that track antimalarial treatment success rates in everyday medical environments. The World Health Organization (WHO) supports these studies as essential instruments to identify initial signs of drug resistance while maintaining treatment effectiveness against infections from Plasmodium falciparum and P. vivax. Through Therapeutic Efficacy Studies countries receive evidence-based guidance for updating malaria treatment policies and gain the ability to rapidly respond to changing patterns of parasite resistance. TES functions as an essential surveillance system that allows first- and second-line antimalarial therapies to maintain high success rates in curing patients and blocking transmission.

 

Why TES is Important?

TES helps: Track how first-line and second-line antimalarial drugs function in treatment. Identify initial indicators of drug resistance in Plasmodium falciparum and P. vivax. Ensure evidence-based updates to national drug policy. The program advances India's wider objective to eradicate malaria by the year 2030.

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Key Component 

Design: Prospective, 28-/42-day follow-up, min 50–75 patients per site

PCR correction: Distinguishes reinfection from recrudescence

Outcomes: ETF, LCF, LPF, ACPR as per WHO definitions

Quality control: Site visit checklists at key milestones

Data management: Standardized templates + global database integration

Policy impact: Informs national guidelines; WHO synthesizes via global reports and maps

*ETF, Early Treatment Failure. LCF,  Late Clinical Failure. LPF, Late Parsitemia failure. ACPR, adequate clinical and parasitological response.

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Indian National Guidelines for Malaria TES

Therapeutic Efficacy Studies (TES) form the essential foundation of India's approach to controlling and eradicating malaria. The studies evaluate how well antimalarial drugs work by examining their clinical and parasitological effects to keep treatment protocols effective and adaptable to drug resistance developments. The National Vector Borne Disease Control Programme (NVBDCP) manages TES which research institutes including the National Institute of Malaria Research (NIMR) implement to shape national malaria treatment policies.

1. Official Protocols

• The “Guidelines for Diagnosis & Treatment of Malaria in India” (1st ed. 2009; 2nd ed. 2011/2013), co-developed by NVBDCP and NIMR, outline national strategy for in vivo therapeutic efficacy monitoring. Key TES directives include:

  • Use of directly observed therapy.

  • Sample size of 50–75 patients per site.

  • Follow-up over 28 days for ACTs, incorporating clinical and parasitological evaluations ncvbdc.mohfw.gov.in+15nvbdcp.gov.in+15ncvbdc.mohfw.gov.in+15journals.lww.com+2pubmed.ncbi.nlm.nih.gov+2malariajournal.biomedcentral.com+2.

2. Malaria Elimination Operational Manual (2016)

• Specifies TES frequency: every two years at sentinel sites in elimination-phase areas to timely detect emerging resistance .

3. Molecular Monitoring & Therapeutic Efficacy Studies

• NVBDCP–NIMR network conducts both in vivo TES and molecular analysis of resistance markers (pfmdr1, pfdhfr, pfdhps, pfk13).

• Recent studies in North-Eastern India on artemether-lumefantrine adherence to WHO protocols with high cure rates (~98–99%), but observed mutations highlight ongoing molecular surveillance needs ncvbdc.mohfw.gov.in+15pubmed.ncbi.nlm.nih.gov+15malariajournal.biomedcentral.com+15.

4. National Drug Policy Integration

• The 2013 National Drug Policy for Malaria mandates:

  • Regular TES to trigger policy updates.

  • Fixed-dose ACTs (e.g., AS+SP, AL) replacing monotherapy.

  • Chloroquine retained for P. vivax with 100% therapeutic success in TES nvbdcp.gov.in+15journals.lww.com+15icmr.gov.in+15.

5. Quality Assurance and Diagnostics

• Inclusion of QA protocols for microscopy and RDTs under NVBDCP ensures standardized laboratory practices in TES sites

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Key Component 

Site Selection: Sentinel sites in high-risk and elimination-phase areas

Sample Size: Minimum 50–75 patients per site

Follow-up Duration: 28 days (ACTs), longer if needed

Drug Efficacy: AS+SP, AL for P. falciparum; Chloroquine for P. vivax

Molecular Genotyping: PCR monitoring (pfmdr1, pfdhfr, pfdhps, pfk13)

Quality Control: NVBDCP SOPs for microscopy/RDTs 

Frequency: Biennial TES per Operational Manual

Policy Triggers: Efficacy <90% initiates treatment policy review.

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References:

• World Health Organization (2009). Methods for surveillance of antimalarial drug efficacy. https://www.who.int/publications/i/item/9789241597531 Foundational manual outlining protocols for TES, including follow-up schedules, patient criteria, and outcome classification.

• World Health Organization (2022).

• WHO Malaria Toolkit: Therapeutic Efficacy Studies protocols and templates. https://www.who.int/teams/global-malaria-programme/therapeutic-efficacy-surveillance  Includes protocol templates, data entry forms, PCR-correction tools, and monitoring checklists.

• World Health Organization (2023). Consolidated guidelines for malaria.https://www.who.int/publications/i/item/9789240064898  Integrates TES within broader malaria treatment and surveillance strategies.

• World Health Organization (2020). Global report on antimalarial drug efficacy and drug resistance: 2000–2019. https://www.who.int/publications/i/item/9789240012813 Summary of TES data globally, including resistance trends and programmatic responses.

• NVBDCP/NIMR Guidelines for Diagnosis & Treatment of Malaria in India (2009/2013) malariajournal.biomedcentral.com+4malariajournal.biomedcentral.com+4pubmed.ncbi.nlm.nih.gov+4malariajournal.biomedcentral.com+6cdn.who.int+6icmr.gov.in+6pubmed.ncbi.nlm.nih.gov+1malariajournal.biomedcentral.com+1nvbdcp.gov.in+8nvbdcp.gov.in+8icmr.gov.in+8

• NVBDCP Operational Manual for Malaria Elimination in India (2016) nvbdcp.gov.in

• NVBDCP SOPs for Microscopy & RDT Quality Assurance nvbdcp.gov.in

• Indian Therapeutic Efficacy Studies (e.g., AL in NE India) confirming TES methodology and molecular surveillance. nvbdcp.gov.in+11pubmed.ncbi.nlm.nih.gov+11malariajournal.biomedcentral.com+11​​