PG Students:- Dr. Amol Askar.PG Teachers:- Dr. R. Mankeshwar Dr. C. Rajguru Dr. R. Waghmare

Recent Updates & Critical Evaluation of NVBDCP

• Drug policy 2013

• Global strategic action plan 2016-30

• National framework for malaria elimination 2016-2013

• Malarial vaccine

• Newer dengue and kala azar vaccines

• Newer technology like GIS maping, remote sensing.

• Critical evaluation

Contents of presentation

• The National Drug Policy on Malaria was first formulated in 1982 and has subsequently been reviewed and revised periodically.

• The present National Drug Policy for Malaria (2013) has been drafted keeping in view the availability of more effective antimalarial drugs and drug resistance status in the country.

Drug Policy for Malaria 2013

Evolution of Drug policy

1st drug policy Risk areas

introduced

AS+SP

AL in North-East states

Universal ACT

• All fever cases should be suspected of malaria and investigated for confirmation of malaria by Microscopy or Rapid Diagnostic Kit (RDK)

• The private healthcare providers should also follow the common National Guidelines for treatment of malaria as per the Drug Policy 2013

• P. vivax cases should be treated with Chloroquine (3 days) and Primaquine (14 days).

• P. falciparum cases should be treated with ACT = Artesunate (3 days) + Sulphadoxine- Pyrimethamine (1 day) + primaquine single dose on day 2.

• Due to reports of resistance to drug SP In North Eastern States, TAC recommended to use the Coformulated tablet of ARTEMETHER( 20 mg) - LUMEFANTRINE (120 mg (ACT-AL)

• Production and sale of Artemisinin monotherapy has been banned in India.

• Pregnant women with uncomplicated P. falciparum should be treated as follows:– 1st Trimester: Quinine– 2nd & 3rd Trimester: ACT

• Where parasitological diagnosis is not possible, suspected malaria cases will be treated with full course of Chloroquine, till the results of microscopy are received.

• Presumptive treatment with Chloroquine is no more recommended

1. Chloroquine: 25 mg/kg body weight divided over three days 1. 10 mg/kg on day 1,2. 10 mg/kg on day 2 and3. 5 mg/kg on day 3.

2. Primaquine*: 0.25 mg/kg body weight daily for 14 days.Primaquine is contraindicated in infants, pregnant women and individuals with G6PD deficiency.

Treatment of Vivax Malaria

A. In Other States (other than North-Eastern States):

1. Artemisinin based Combination Therapy (ACT-SP)• Artesunate 4 mg/kg body weight daily for 3 days Plus• Sulfadoxine (25 mg/kg body weight) – Pyrimethamine (1.25 mg/kg

body weight) on first day.

2. Primaquine*: 0.75 mg/kg body weight on day 2.

Treatment of Falciparum Malaria

2. Primaquine*: 0.75 mg/kg body weight on day 2

B. In North-East states1. Co-formulated tablet of ARTEMETHER (20 mg) - LUMEFANTRINE (120 mg) (ACT-AL)

Chemoprophylaxis for longer stay (more than 6 weeks) • Mefloquine: • 250 mg weekly for adults and should be administered 2 weeks

before, during and 4 weeks after exposure. – Note: Mefloquine is contraindicated in individuals with history of

convulsions, neuropsychiatric problems and cardiac conditions.

ChemoprophylaxixShort term chemoprophylaxis (up to 6 weeks) Doxycycline: • 100 mg once daily for adults and 1.5 mg/kg once daily for

children .• started 2 days before travel and continued for 4 weeks after

leaving the malarious area. • Note: It is not recommended for pregnant women and children less than

8 years.

Global strategic action plan 2016-30

GOALS MILESTONES TARGET

2020 2025 2030

1) Reduce malaria mortality rates globally compared with 2015

At least 40%

At least 75% At least 90%

2) Reduce malaria case incidence globally compared with 2015

At least 40%

At least 75% At least 90%

3) Eliminate malaria from countries in which malaria was transmitted in 2015

At least10 countries

At least20 countries

At least35 countries

4) Prevent re-establishment of malaria in all countries that are malaria-free

Re-establishmentPrevented

Re-establishmentPrevented

Re-establishmentprevented

All countries can accelerate efforts towards elimination through combinations of interventions tailored to local contexts.

Country ownership and leadership, with involvement and participation of communities, are essential to accelerating progress through a multisectoral approach.

Improved surveillance, monitoring and evaluation, as well as stratification by malaria disease burden, are required to optimize the implementation of malaria interventions.

Equity in access to health services especially for the most vulnerable and hard-to-reach populations is essential

Innovation in tools and implementation approaches will enable countries to minimize their progression along the path to elimination.

PRINCIPLES

• Consists of 3 major pillars + 2 supporting elements

• Maximize impact of today’s life-saving tools Pillar 1. Ensure universal access to malaria prevention, diagnosis

and treatment

Pillar 2. Accelerate efforts towards elimination and attainment of malaria-free status

Pillar 3. Transform malaria surveillance into a core intervention

• Supporting elements:1) Innovation and research2) Strong enabling environment

STRATEGIC FRAMEWORK

o Basic research to foster innovation and the development of new and improved tools

o Implementation research to optimize impact and cost−effectiveness of existing tools and strategies

o Action to facilitate rapid uptake of new tools, interventions and strategies

1. Harnessing innovation and expanding research

o Strong political and financial commitments

o Multisectoral approaches, and cross-border and regional collaborations

o Increase domestic and international financing.

o Strengthen health workforce and malaria expert base.

o Encourage pvt. Sector cooperation.

2. Strengthening the enabling environment

• Proportion of population at risk who slept under ITN previous night

• Proportion of population at risk protected by IRS within the past 12 months

• Proportion of pregnant women who received at least 3 or more doses of intermittent preventive treatment of malaria while attending antenatal care during their previous pregnancy (sub-Saharan Africa only)

• Proportion of patients with suspected malaria who receive a parasitological test

• Proportion of patients with confirmed malaria who receive first-line antimalarial treatment according to national policy

• Proportion of expected health facility reports received at national level

• Proportion of malaria cases detected by surveillance systems

• Proportion of cases investigated (programmes engaged in elimination)

• Proportion of foci investigated (programmes engaged in elimination)

Outcome

Parasite prevalence: proportion of the population with evidence of infection with malaria parasites

Malaria case incidence: number of confirmed malaria cases per 1000 persons per year

Malaria mortality rate: number of malaria deaths per 100 000 persons per year

Number of countries that have newly eliminated malaria since 2015

Number of countries that were malaria-free in 2015 in which malaria was re-established

Impact

National Framework for malaria elimination in India 2016-2030

GOALS

Eliminate malaria (zero indigenous cases) throughout the entire country by 2030

Maintain malaria–free status in areas where malaria transmission has been interrupted and prevent re-introduction of malaria.

VISION• Eliminate malaria nationally and contribute to improved health,

quality of life and alleviation of poverty.

o Eliminate malaria from all 26 low (Category 1) and moderate (Category 2) transmission states/union territories (UTs) by 2022;

o Reduce the incidence of malaria to less than 1 case per 1000 population per year in all states and UTs and their districts by 2024;

o Interrupt indigenous transmission of malaria throughout the entire country, including all high transmission states and union territories (UTs) (Category 3) by 2027; and

o Prevent the re-establishment of local transmission of malaria in areas where it has been eliminated and maintain national malaria-free status by 2030 and beyond

OBJECTIVES

Sr. no.

Category of states / UTs Definition

1 Category 0: Prevention ofre-establishment phase

States/UTs with zero indigenous cases of malaria.

2 Category 1: Elimination phase States/UTs (15) including their districts reporting an API of less than 1 case per 1000 population at risk.

3 Category 2: Pre-elimination phase

States/UTs (11) with an API of less than 1 case per 1000 population at risk,

but some of their districts are reporting an API of 1/1000 or above.

4 Category 3: Intensified controlphase

States/UTs (10) with an API of 1 case per 1000 population at risk or above.

Categorisation of states

By 2020

• Transmission of malaria interrupted and zero indigenous cases and deaths due to malaria attained in all 15 states/UTs under Category 1 (elimination phase) in 2014 (base year).

• All 11 states/UTs under Category 2 (pre-elimination phase) in 2014 enter into Category 1 (elimination phase).

• 5 states/UTs under Category 3 (intensified control phase) in 2014 enter into Category 2 (pre-elimination phase).

• 5 states/UTs under Category 3 (intensified control phase) in 2014 reduce malaria transmission but continue to remain in Category 3.

By end of 2016

• All states/UTs have included malaria elimination in their broader health policies and planning frameworks.

By 2022

• Transmission of malaria interrupted and zero indigenous cases and deaths due to malaria attained in all 26 states/UTs that were under Categories 1 and 2 in 2014

• 5 states/UTs which were under Category 3 (intensified control phase) in 2014 enter into elimination phase.

• 5 states/UTs which were under Category 3 (intensified control phase) in 2014 enter into pre-elimination phase.

• An estimated reduction in malaria of 30–35% at the national level compared with 2014.3

By 2024

• All states/UTs and their respective districts reduce API of less than 1 case per 1000 population at risk and sustain zero deaths due to malaria while maintaining fully functional malaria surveillance to track, investigate and respond to each case throughout the country.

• Transmission of malaria interrupted and zero indigenous cases and deaths due to malaria attained in all 31 states/UTs.

• Five states/UTs which were under Category 3 (intensified control phase) in 2014 enter into elimination phase.

By 2030

• The re-establishment of local transmission prevented in areas where malaria has been eliminated.

• The malaria-free status maintained throughout the nation.

• India initiates the process of WHO certification of malaria elimination.

By 2027• The indigenous transmission of malaria in India interrupted.

• Massive scaling up of existing disease management and preventive approaches and tools

• One-stop centres or mobile clinics on fixed days in tribal or conflict affected areas to provide malaria diagnosis and treatment

• increasing community awareness with the involvement of other agencies and service providers as required.

• Strengthening all district and sub-district hospitals

• Establishment of a robust supply chain management system.

• Maintenance of an optimum level of surveillance using appropriate diagnostic measures

• Equipping all health institutions, especially in high-risk areas, with microscopy facilities and RDTs

Key interventions Intensified control phase

• Mandatory notification of each case of malaria from the private sector, other organized government sectors or any other health facility.

• A strict total coverage of all active foci by effective vector control measures.

• State and national level malaria elimination database established and operational.

• Surveillance of special groups, migrant populations or populations residing in the vicinity of industrial areas

• Establishment of an effective epidemic forecasting and response system.

• Setting up of national level lab which will have 2 functions– Training of master trainers and accreditation/certification of Microscopists– All positive and a fixed percentage of negative slides will be referred to this

laboratory for confirmation of diagnosis and cross-checking.

Key interventions in elimination phase

1) No. & incidence rate of confirmed malaria cases classified according to sex, age, parasite species & other parameters.

2) No.& incidence of severe malaria cases as well as case fatality rate.

3) Number of malaria cases in pregnancy.

4) Number and type of malaria foci (in areas eligible for elimination)

5) Number of confirmed deaths due to malaria.

6) No. of states/UTs which have eliminated malaria & are currently in the phase of prevention of re-establishment of local transmission.

7) Number of states/UTs which are in elimination phase.

8) Number of states/UTs which are in pre-elimination phase.

9) Number of states/UTs which are in intensified control phase.

Impact

1) Proportion of population at risk who slept under an insecticide-treated net/LLIN the previous night.

2) Proportion of population at risk protected by indoor residual spraying within the past 12 months.

3) Proportion of patients with confirmed malaria who received anti-malarial treatment as per national policy.

4) Proportion of cases investigated and classified (in areas eligible for elimination).

5) Proportion of foci investigated and classified (in areas eligible for elimination).

6) Proportion of expected monthly reports received from health facilities at the national and subnational level.

Outcome

Newer Vaccines

• R & D in this field has been an area of intense effort by many groups over the last few decades. Despite this, there is currently no licensed malaria vaccine.

• More than 20 other vaccine constructs are currently being evaluated in clinical trials or are in advanced preclinical development.

Malarial vaccines

Types of malaria vaccines• Vaccine developers are trying to develop three types of

vaccines: 1] Pre-erythrocytic vaccine candidates 2] Blood-stage vaccine candidates 3] Transmission-blocking vaccine candidates

The role of WHO:

• WHO- Initiative for Vaccine Research (IVR) with collaboration with PATH- Malaria Vaccine Initiative (MVI )to accelerate the availability of a safe, effective and affordable Malaria vaccine

RTS,S/AS01 • Developed through a partnership between GlaxoSmithKline

Biologicals (GSK) and the PATH Malaria Vaccine Initiative (MVI),

• Support from the Bill & Melinda Gates Foundation and from a network of African research centres that performed the studies.

• 1st malarial vaccine which completed Phase 3 testing and obtained a positive scientific opinion by a stringent medicines regulatory authority.

• May 2009 :- Phase 3 trial of RTS,S/AS01 began

• 2011 :- completed enrolment with 15 460 children in seven countries in sub-Saharan Africa

• April 2015 :- Final results were published

• July 2015 :- The European Medicines Agency issued a positive scientific opinion on the vaccine’s risk-benefit balance

• October 2015 :- 2 independent WHO advisory groups recommended the pilot implementation of RTS,S/ASO1 in parts of 3-5 sub-Saharan African countries

• WHO has adopted these recommendations and is strongly supportive of the need to proceed with the pilots

• In October 2015, WHO jointly convened the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) to review all evidence regarding RTS,S relevant for global policy.

• SAGE/MPAC have recommended large-scale implementation pilots, to evaluate the extent to which the protection demonstrated in children aged 5–17 months in the Phase 3 trial can be replicated in the context of the routine health system, particularly in view of the need for a 4-dose schedule that requires new immunization contacts

• RTS,S is a vaccine against Plasmodium falciparum,

• It offers no protection against P. vivax malaria,

• The vaccine is being considered as a complementary malaria control tool in Africa that could potentially be added to – and not replace – the core package of proven malaria preventive, diagnostic and treatment interventions.

• The first clinical trial of a new vaccine for visceral leishmaniasis (VL) has been launched by the Infectious Disease Research Institute (IDRI)

• The IDRI vaccine, k/a LEISH–F3 + GLA-SE, is a highly purified, recombinant vaccine.

• It incorporates two fused Leishmania parasite proteins and a powerful adjuvant to stimulate an immune response against the parasite.

• The Phase 1 trial is taking place in Washington State, with a companion Phase 1 trial planned in India, an epicenter of the disease.

Kala Azar vaccine

• Phase 1 clinical trial enroll 36 adult volunteers in Washington State. They will be randomly assigned to receive one of three versions of the vaccine, which differ in the amount of adjuvant included. The trial will evaluate the safety and immunogenicity of each version

• A second Phase 1 trial will take place in India, where IDRI is transferring its vaccine technology to the Gennova Biopharmaceuticals, Pune.

• Beginning later in 2012, the Indian bio therapeutics and vaccine manufacturer produced the LEISH-F3 + GLA-SE vaccine. It was tested in healthy Indian adults, in collaboration with the Banaras Hindu University in Varanasi, India.

Clinical trials :• Three tetravalent live-attenuated vaccines are under

development in phase II and phase III clinical trials, and 3 other vaccine candidates (based on subunit, DNA and purified inactivated virus platforms) are at earlier stages of clinical development.

• A live-attenuated tetravalent vaccine based on chimeric yellow fever-dengue virus (CYD-TDV), has progressed to phase III efficacy studies.

• Vaccine could be available from 2016 .

The role of WHO:• The Initiative for Vaccine Research (IVR) as a part of Dengue

Vaccine Initiative (DVI )to accelerate the availability of a safe, effective and affordable Dengue vaccine

Dengue vaccine

Image courtesy from Dengue vaccine initiative : downloaded from http://www.denguevaccines.org/

• First dengue vaccine, Dengvaxia (CYD-TDV) by Sanofi Pasteur, was first registered in Mexico in December, 2015.

• CYD-TDV is a live recombinant tetravalent dengue vaccine

• 3-dose series on a 0/6/12 month schedule in Phase III clinical studies

• It registered for use in 9-45 years of age living in endemic areas.

• The WHO SAGE on Immunization reviewed CYD-TDV in April 2016 and recommended countries consider introduction of the vaccine only in geographic settings (national or subnational) with high endemicity.

• A WHO vaccine position paper will be published outlining WHO recommendations in July 2016

Dengvaxia (CYD-TDV)

• Remote Sensing is the science and art of acquiring information about material objects, area, or phenomenon, without coming into physical contact with the objects, or area, or phenomenon under investigation.

• 2 Types Passive : Makes use of sensors that detect the reflected or

emitted electro-magnetic radiation from natural sources.

Active : Makes use of sensors that detect reflected responses from objects that are irradiated from artificially-generated energy sources (RADAR, LIDAR, SONAR, Infra-red).

Remote Sensing

• A Geographical Information System (GIS) is a computer system for processing, storing, checking, integrating, manipulating, analysing and displaying data related to positions on the surface of the earth

• Allows visual display of tabular information, providing an interface between the data and map.

• Makes it easy to present information to key decision-makers quickly, efficiently and effectively.

Geographical Information System

USE OF GIS & REMOTE SENSING IN HEALTH

1. Surveillance of Vector borne diseases: Malaria, Filaria, JE etc.

2. Emergency Medical Services Delivery, 108, 911

3. Monitoring contamination of ground water

4. Air pollution and its impact on human health

Recent uses:

• Early warning system for the outbreak of JE in Dibrugarh, Assam

• Study on Cholera in Bangladesh in collaboration with CDC

• In Patna: to assist immunization activities in interior areas using

GPS in collaboration with CDC

• Evaluation of Immunization coverage using GIS in Gujarat

DISEASES CURRENTLY UNDER SURVEILLANCE USING REMOTE SENSING AND GIS IN INDIA

• JAPANESE ENCEPHALITIS

• MALARIA

• DENGUE

• FILARIA

Early warning systems for JE in Assam

A Project was done on “Development of an early warning system for the outbreak of JE with the help of Remote Sensing and GIS in conjunction with the epidemiological studies in Assam”

by RMRC, Dibrugarh and NESAC, Umiam from 2002-2006

Source: RMRC, Dibrugarh

1) Lifelens Project for Malaria Remote Testing with Mobile Phones:• Region: Graduate Students from multiple US cities• Country: USA• Grant: Microsoft Imagine Cup 2011 of $75,000 as finalist (2nd place)• Status: Won the Grant but status of Project unknown

2) SMS to Monitor Malaria Monitoring with Mobile Phones:• Region: Africa & Middle East• Country: Uganda• Partners: Uganda Ministry of Health;• Foundation for Innovative New Diagnostics (FIND); Earth Institute at Columbia

University; WHO;• Status: RapidSMS reporting system implemented in 140 clinics

3) Dengue and Malaria Monitoring with Mobile Phones:• Region: Latin America & Carribean

Country: MexicoStatus: Software to be developed and tested in field

4) WHO and MMV launch new Malaria Mapping tool – Global Malaria Mapper• Region: Worldwide• Country: Worldwide• Partners: WHO Malaria Programme• Medicines for Malaria Venture (MMV) • Status: Launched on World Malaria Day 2013 (April 24, 2013)

5) CDC's Mobile game app - Solve The Outbreak • Region: Any • Country: Any• Developers: CDC• Status: Solve the Outbreak app on iOS available free of cost

6) Integrated Mobile based Disease Surveillance Project• Region: Punjab State• Country: India• Developers: Punjab Infotech Ltd. Integrated Disease Surveillance Project (IDSP)• Status: Android Mobile App, free

Critical review

• Tribal & Ignorant population

• Environmental sanitation

• Political will

• Community participation

• Comprehensiveness of programme

• Surveillance

• Trained manpower

• Diagnosis

• Treatment

• Bednet programme

• Health delivery system

•THANK YOU