Document of

The World Bank

FOR OFFICIAL USE ONLY

Report No: 43572-IN

PROJECT APPRAISAL DOCUMENT

ON

A PROPOSED CREDIT

IN THE AMOUNT OF SDR 319.9 MILLION (US$521 MILLION EQUIVALENT)

TO

THE REPUBLIC OF INDIA

FOR

NATIONAL VECTOR BORNE DISEASE CONTROL AND POLIO ERADICATION SUPPORT PROJECT

June 26, 2008

Human Development Sector Unit India Country Management Unit South Asia Region This document has a restricted distribution and may be used by recipients only in the performance of their official duties. Its contents may not otherwise be disclosed without IDA authorization.

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CURRENCY EQUIVALENTS

(Exchange Rate Effective June 12, 2008) Currency Unit = Rupee

Rupee 42.81 = US$1 SDR 1 = US$1.62895

FISCAL YEAR

April 1 - March 31

ABBREVIATIONS AND ACRONYMS

ABER ACD ACT AFP API ASHA AWW BCC BE BPL C&AG CAS CBOs CDC CIB COMBI CPAR CQ DALY DBS DC DDC DDT DEA DFID DIR DOTS DPs EAC EMP EPW F&C FTD GAAP GFATM GIS GOI ICB

Annual Blood Slide Examination Rate Active Case Detection Artemisinin-based Combination Therapy Acute Flacid Paralysis Annual Parasite Incidence Accredited Social Health Activist Anganwadi worker Behavior Change Communication Budget Estimates Below the Poverty Line Controller and Auditor General Country Strategy Community-based Organizations Center for Disease Control, Atlanta Central Insecticide Board Communications for Behavioral Impact Country Procurement Assessment Report Chloroquine Disability-Adjusted Life Year Domestic Budget Support Direct Contracting Drug Distribution Center Dichloro diphenyl trichloroethane Department of Economic Affairs, GOI UK Department for International Development Detailed Implementation Review Directly Observed TB Treatment, Short Course Development Partners Externally Assisted Component Environmental Management Plan Empowered Procurement Wing Fraud and Corruption Fever Treatment Depot Governance and Accountability Action Plan Global Fund to Fight AIDS, Tuberculosis and Malaria Geographic Information System Government of India International Competitive Bidding

FOR OFFICIAL USE ONLY

This document has a restricted distribution and may be used by recipients only in the performance of their official duties. Its contents may not be otherwise disclosed without World Bank authorization.

ICMR IDR IDSP IEAG IEC IDA IRS ITN IVM JE JMM KfW LF LLIN LQAS MDA MDGs M&E MIS MOHFW MOU MPHS MPHW MTR MTS NCB NGO NID NIMR NMCP NPSP NRHM NS NVBDCP OPV PBF PCD PDO Pf PHC PIP PPP PPI PRI Pv QER RCH RDK RDT RMRI SABA

Indian Council of Medical Research In-depth Review Integrated Disease Surveillance Project India Expert Advisory Group Information, Education and Communication International Development Association Indoor Residual Spraying Insecticide-treated Net Integrated Vector Management Japanese Encephalitis Joint Monitoring Mission Kreditanstalt fur Wiederaufbau, Germany Lymphatic Filariasis Long-lasting Insecticidal Net Lot Quality Assurance Sampling Mass Drug Administration Millennium Development Goals Monitoring and Evaluation Management Information System Ministry of Health and Family Welfare Memorandum of Understanding Multi-purpose Health Supervisor Multi-purpose Health Worker Mid-term Review Malaria Technical Supervisor National Competitive Bidding Non-Governmental Organization National Immunization Day National Institute of Malaria Research National Malaria Control Program National Polio Surveillance Project - India National Rural Health Mission National Shopping National Vector Borne Disease Control Program Oral Polio Vaccine Performance Based Financing Passive Case Detection Project Development Objectives Plasmodium falciparum Primary Health Center Project Implementation Plan Public Private Partnerships Pulise Polio Immunization Panchayat Raj Institutions Plasmodium vivax Quality Enhancement Review Reproductive and Child Health Rapid Diagnostic Kit Rapid Diagnostic Test Rajendra Memorial Research Institute Social and Beneficiary Assessment

iv

SC/ST SDR SIA SIM SIHS SMO SNID SOE SP SPAR SPIPs SFR SPR TOR TA UNICEF USAID UNOPS VBD VCP VVM WHO

Scheduled Caste/ Scheduled Tribe Special Drawing Rights Supplementary Immunization Activity Sector Investment and Maintenance Loan State Integrated Health Society Surveillance Medical Officer Sub-national Immunization Day Statement of Expenses Sulphadoxine-pyrimethamine State Procurement Assessment Report State Program Implementation Plans Slide falciparum rate Slide Positivity Rate Terms of Reference Technical Assistance United Nations Children Education Fund United States Agency for International Development United Nations Office for Project Services Vector-borne Disease Vulnerable Community Plan Vaccine Vial Monitors World Health Organization

Vice President Praful C. Patel Country Director Isabel M. Guerrero Senior Country Manager Fayez S. Omar Sector Director Michal Rutkowski Sector Manager Benjamin Loevinsohn (Acting) Task Team Leaders G N.V. Ramana, Peter Berman

The purpose of this Corrigendum is to introduce changes to PAD so the project is fully compliant with the sanctions reforms unanimously approved by the Executive Directors of the Bank in August 2006 including the Anti-Corruption provisions and General Conditions for IBRD Loans and IDA credits. The “Guidelines: Procurement under IBRD Loans and IDA Credits” dated May 2004, revised in October 2006; and “Guidelines: Selection and Employment of Consultants by World Bank Borrowers” dated May 2004, revised in October 2006 will apply. It also updates the planned dates of procurement. I. The following 9 changes have been inserted in different sections of the PAD to make the Project design compliant with the 2006 Guidelines:

No.

Before change

After change

1

Page 20 Procurement

A. The Vector Borne Control Component

Revised text: Procurement Procurement for the proposed project will be carried out in accordance with the World Bank’s “Guidelines: Procurement under IBRD Loans and IDA Credits” dated May 2004, revised in October 2006; and “Guidelines: Selection and Employment of Consultants by World Bank Borrowers” dated May 2004, revised in October 2006, and the provisions stipulated in the Legal Agreement.

A. The Vector Borne Control Component

2 Page 99 Annex 8: Procurement Arrangements

A. The Vector Borne Disease Component I. General

Revised text: Annex 8: Procurement Arrangements

Procurement for the proposed project will be carried out in accordance with the World Bank’s “Guidelines: Procurement under IBRD Loans and IDA Credits” dated May 2004, revised in October 2006; and “Guidelines: Selection and Employment of Consultants by World Bank Borrowers” dated May 2004, revised in October 2006, and the provisions stipulated in the Legal Agreement. A. The Vector Borne Disease Component I. General

Corrigendum

No.

Before change

After change

3

Page 107 Procurement Manual In case the procurement is to be decentralized to the state level in future based on the outcomes of ongoing capacity assessment of the state level agencies, MOHFW will prepare a procurement manual to guide the implementing agencies at all the levels in handling the procurement. This manual will be shared with IDA and finalized before delegating any procurement. All the contracts issued under the sub-project will follow the World Bank’s Guidelines: Procurement under IBRD Loans and IDA Credits” dated May 2004; and “Guidelines: Selection and Employment of Consultants by World Bank Borrowers” dated May 2004 respectively. In case of any inconsistency between the procurement manual and IDA Guidelines, the latter will prevail.

Revised text: Procurement Manual In case the procurement is to be decentralized to the state level in future based on the outcomes of ongoing capacity assessment of the state level agencies, MOHFW will prepare a procurement manual to guide the implementing agencies at all the levels in handling the procurement. This manual will be shared with IDA and finalized before delegating any procurement. In case of any inconsistency between the procurement manual and IDA Procurement/Consultant Guidelines dated May 2004, revised in October 2006, the latter will prevail.

4

Page 108 IDA’s SBD and Standard RFP, as agreed with IDA, will be used for all procurement of goods and consultancy under the sub-project. In addition to IDA’s Procurement and Consultants’ Guidelines and SBD/RFP Documents, Malaria Tool Kit published by IDA ……

Revised text: IDA’s SBD and Standard RFP, as agreed with IDA, will be used for all procurement of goods and consultancy under the sub-project. In addition to IDA’s Procurement and Consultants’ Guidelines dated May 2004, revised in October 2006 and SBD/RFP Documents, Malaria Tool Kit published by IDA ……

5

Page 109 Use of Procurement Agent …….. In this regard, the MOHFW has already selected UNOPS to act as procurement agent for central health sector projects including NVBDCP. The procurement agent (commercial or UN agency acting as procurement agent) will follow the IDA Guidelines dated May 2004 and other procurement arrangements agreed for the sub-project. ……..

Revised text: Use of Procurement Agent ……… In this regard, the MOHFW has already selected UNOPS to act as procurement agent for central health sector projects including NVBDCP. The procurement agent (commercial or UN agency acting as procurement agent) will follow the IDA Guidelines dated May 2004, revised in October 2006, and other procurement arrangements agreed for the sub-project. ……

No.

Before change

After change

6

Page 110 Disclosure Invitation for Bids (IFB) for goods and equipment for all ICB contracts and advertisement for calling of Letters of Expression of Interest (EOI) for short listing of consultants for services costing more than $250,000 equivalent will be published in UNDB and dgMarket as well as procurement agent’s website. …..

Revised text: Disclosure Invitation for Bids (IFB) for goods and equipment for all ICB contracts and advertisement for calling of Letters of Expression of Interest (EOI) for short listing of consultants for services costing more than $200,000 equivalent will be published in UNDB and dgMarket as well as procurement agent’s website. …..

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Page 111 Sanction/Debarment/Blacklisting In case of noticing any corrupt or fraudulent practice during the procurement process, the Government of India (or the state government once the decentralized procurement is permitted) will take action against the involved bidders/suppliers as per its administrative procedure. Such adverse action taken by the Government could be treated as evidence of poor performance of such bidders participating in the future bidding processes. In addition, IDA could also initiate appropriate action including sanction/debarment of involved parties as per the Procurement/Consultant Guidelines.

Revised text: Sanction/Debarment/Blacklisting In case of noticing any corrupt or fraudulent practice during the procurement process, the Government of India (or the state government once the decentralized procurement is permitted) will take action against the involved bidders/suppliers as per its administrative procedure. Such adverse action taken by the Government could be treated as evidence of poor performance of such bidders participating in the future bidding processes. In addition, IDA could also initiate appropriate action including sanction/debarment of involved parties as per the Procurement/Consultant Guidelines dated May 2004, revised in October 2006.

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Page 112 Post Award Review by IDA

All contracts below the prior review threshold procured will be subject to periodic post review (in accordance with Paragraph 5 of Appendix 1 to IDA’s Procurement Guidelines) on a sample basis. This also includes…

Revised text: Post Award Review by IDA

All contracts below the prior review threshold procured will be subject to periodic post review (in accordance with Paragraph 5 of Appendix 1 to IDA’s Procurement/Consultant Guidelines dated May 2004, revised in October 2006) on a sample basis. This also includes…

9 Page 116 Appendix 2 to Annex 8: Procurement disclosure Requirements as per IDA’s Guidelines

Revised text: Appendix 2 to Annex 8: Procurement disclosure Requirements as per IDA’s Guidelines dated May 2004, revised in October 2006

II. Page 114, Appendix 1 to Annexure 8: The below revised table replaces the one included in the PAD. The planned dates of procurement have been revised.

A) Goods, Commodities, Equipment and Non-Consultancy Services (ICB and DC)

Description Method of

Procurement

Category Estimated

Cost

(Million

US$)1

Submission

of Bid

Document to

the Bank

No Objection

of Bid

documents by

the World

Bank

Publication of

IFB in

Newspapers and

UNDB/

dgMarket and

beginning of sale

of bid document

Receipt and

Opening of

Bids

Submission of

BER to Bank

for No

Objection

Receipt of No

Objection of

Bank for BER

Signing of

the contract

Malaria Kits ICB Drugs/ Medical Supplies 2.658 15-Dec-08 30-Dec-08 05-Jan-09 20-Feb-09 15-Mar-09 25-Mar-09 05-Apr-09

Combi-Pack ICB Drugs/ Medical Supplies 2.713 15-Dec-08 30-Dec-08 05-Jan-09 20-Feb-09 15-Mar-09 25-Mar-09 05-Apr-09

Arteether Inj. ICB Drugs/ Medical Supplies 0.463 15-Dec-08 30-Dec-08 05-Jan-09 20-Feb-09 15-Mar-09 25-Mar-09 05-Apr-09

Synt. Pyre. Liq. ICB Insecticide 1.673 15-Dec-08 30-Dec-08 05-Jan-09 20-Feb-09 15-Mar-09 25-Mar-09 05-Apr-09

Synt. Pyre. Wdp. ICB Insecticide 3.000 10-Jun-08 14-Jun-08 15-Jun-08 29-July-08 15-Aug-08 25-Aug-08 05-Sep-08

RDK Kala Azar ICB/DC Drugs/ Medical Supplies 0.533 15-Aug-08 30-Aug-08 05-Sep-08 20-Oct-08 15-Nov-08 25-Nov-08 05-Dec-08

Capsule Miltefosine DC Drugs/ Medical Supplies 2.285 15-Feb-09 28-Feb-09 -- 20-Mar-09 30-Mar-09 10-Apr-09 20-Apr-09

LLINs ICB Bed Net 6.328 15-Feb-09 28-Feb-09 05-Mar-09 20-Apr-09 15-May-09 25-May-09 05-June-09

Artesunate Tab. ICB Drugs/ Medical Supplies 0.192 15-Aug-08 30-Aug-08 05-Sep-08 20-Oct-08 15-Nov-08 25-Nov-08 05-Dec-08

Tab. Sulpha-

pyremethamine

ICB Drugs/ Medical Supplies 0.238 15-Aug-08 30-Aug-08 05-Sep-08 20-Oct-08 15-Nov-08 25-Nov-08 05-Dec-08

1 Each of the procurement will have multiple lots/schedules and hence the size of the contract awarded may be lesser than the estimated costs indicated above

v

INDIA

NATIONAL VECTOR BORNE DISEASE CONTROL AND POLIO ERADICATION SUPPORT PROJECT

CONTENTS

Page

A. STRATEGIC CONTEXT AND RATIONALE ................................................................... 1

1. Country and sector issues................................................................................................................. 1

2. Rationale for Bank involvement ...................................................................................................... 4

3. Higher level objectives to which the project contributes ................................................................. 5

B. PROJECT DESCRIPTION................................................................................................... 5

1. Lending instrument .......................................................................................................................... 5

2. Project development objective and key indicators........................................................................... 5

3. Project Components and Sub-Components...................................................................................... 6

4. Lessons learned and reflected in the project design......................................................................... 9

5. Alternatives considered and reasons for rejection ........................................................................... 9

C. IMPLEMENTATION .......................................................................................................... 10

1. Partnership Arrangements.............................................................................................................. 10

2. Institutional and implementation arrangements............................................................................. 11

3. Monitoring and evaluation of outcomes/results............................................................................. 12

4. Sustainability ................................................................................................................................. 13

5. Critical risks and possible controversial aspects:........................................................................... 13

6. Loan/credit conditions and covenants:........................................................................................... 15

D. APPRAISAL SUMMARY ................................................................................................... 16

1. Economic and financial analyses ................................................................................................... 16

2. Technical........................................................................................................................................ 17

3. Fiduciary ........................................................................................................................................ 19

4. Social ............................................................................................................................................. 22

5. Environment................................................................................................................................... 22

6. Policy exceptions and readiness ....................................................................................................... 24

Annex 1A: Country and Sector or Program Background (VBD) .......................................... 25

Annex 1B: Country and Sector or Program Background (Polio) .......................................... 32

vi

Annex 2: Major Related Projects Financed by IDA/Bank ..................................................... 39

Annex 3A: Results Framework and Monitoring Matrix ....................................................... 41

Annex 3B: Impact Evaluation (VBD) ...................................................................................... 56

Annex 4: Detailed Project Description..................................................................................... 59

Annex 5: Project Costs .............................................................................................................. 76

Annex 6: Implementation Arrangements ................................................................................ 79

Annex 7: Financial Management Assessment .......................................................................... 89

Annex 8: Procurement Arrangements...................................................................................... 99

Annex 9: Governance and Accountability Action Plan (GAAP).......................................... 118

Annex 10: Economic and Financial Analysis ......................................................................... 125

Annex 11: Safeguard Policy Issues.......................................................................................... 132

Annex 12A: Project Preparation ............................................................................................ 152

Annex 12B: Enhanced Implementation Support.................................................................. 154

Annex 13: Documents in the Project File .............................................................................. 159

Annex 14: Statement of Loans and Credits............................................................................ 160

Annex 15: Country at a Glance ............................................................................................... 164

vii

INDIA

NATIONAL VECTOR BORNE DISEASE CONTROL AND POLIO ERADICATION

SUPPORT PROJECT

PROJECT APPRAISAL DOCUMENT

SOUTH ASIA

SASHD

Date: June 26, 2008 Team Leaders: Gandham N. V. Ramana, Peter Berman

Country Director: Isabel Guerrero Sector Director: Michal Rutkowski Sector Manager: Benjamin Loevinsohn (Acting)

Sector: Health (100%) Theme: Other Communicable Diseases (P)

Project ID: P094360 Environmental screening category: B Lending Instrument: Sector Investment Loan Safeguard screening category: Limited

impact (S2) Project Financing Data

[ ] Loan [X] Credit [ ] Grant [ ] Guarantee [ ] Other: For Loans/Credits/Others: Total Bank financing (Sum.): US$521million Proposed terms (IDA): Standard Credit with maturity of 35 years.

Financing Plan (US$m)-2007/08 to 2011/12 Source Local Foreign Total

BORROWER/RECIPIENT 0 INTERNATIONAL DEVELOPMENT ASSOCIATION

150 371 521

Total: 150 371 521 Borrower: Government of India India Responsible Agency: Mr. Naresh Dayal, Secretary to Government Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi, India 110 011 Tel: (91-11) 23061863

Estimated disbursements (Bank FY/US$m) FY 2009 2010 2011 2012 2013 Total Annual 42 138 155 90 96 521 Cumulative 42 180 335 425 521 521

viii

Project implementation period: Start August 1, 2008 End: June 30, 2013 Expected effectiveness date: August 1, 2008 Expected closing date: December 31, 2013 Does the project depart from the CAS in content or other significant respects? Ref. PAD A.3 [ ]Yes [X] No

Does the project require any exceptions from Bank policies? Ref. PAD D.6 Have these been approved by Bank management? Is approval for any policy exception sought from the Board?

[ ]Yes [X] No [ ]Yes [ ] No [ ]Yes [ ] No

Does the project include any critical risks rated “substantial” or “high”? Ref. PAD C.5

[X]Yes [ ] No

Does the project meet the Regional criteria for readiness for implementation? Ref. PAD D.7 [X]Yes [ ] No

Project development objective Ref. PAD B.2, Technical Annex 3 The Project Development Objective (PDO) is to enhance the effectiveness of government response to control malaria, eliminate kala azar and eradicate polio. This will be achieved by an increase in the number of people benefiting from effective prevention, diagnosis and treatment services for malaria and kala azar, and vaccination against polio. Project description Ref. PAD B.3, Technical Annex 1a, 1b, and 4 The project will have four components: Component 1: Improving Access to and Use of Services for Control of Malaria. This component will include the following sub-components: 1a: Improving Malaria Case Management; 1b: Strengthening Malaria Surveillance; and 1c: Effective Vector Control

Component 2: Improving Access to and Use of Services for Elimination of Kala Azar. This component will include the following subcomponents: 2a: Improving Kala Azar Case Management; 2b: Strengthening Kala Azar Surveillance; and 2c: Effective Vector Control;

Component 3: Policy and Strategy Development, Capacity Building and Monitoring and Evaluation. This component will include the following sub-components: 3a: Policy and Strategy Development; 3b: Program Management and Capacity Building; and 3c: Monitoring and Evaluation.

Component 4: Improving Polio vaccine availability: This component will support procurement of oral polio vaccines required for high coverage of eligible children under supplemental national and sub-national polio immunization rounds.

Which safeguard policies are triggered, if any? Ref. PAD D.6, Technical Annex 10 Environmental Assessment; Indigenous People; Pest Management Significant, non-standard conditions, if any, for: Board presentation: None. Loan/Credit effectiveness: None Covenants applicable to project implementation: Ref. PAD C.6

The Government of India (GOI) will:

(i) Provide an annual update on progress made in the implementation of evidence

ix

based policies (see Table 1) supported by the project by February 1, of each year

(ii) Ensure timely availability of project inputs to the project districts as per the agreed phasing plan;

(iii) Complete, not later than six months after project effectiveness, baseline surveys

measuring key project indicators using a methodology acceptable to the Association.

(iv) Finalize the design of evaluation studies (see Annex 4) within 6 months of project

effectiveness, start implementing the initial round of evaluation studies from August 1, 2009 and, based on the lessons learnt, finalize the design for scaling up improved practices based on evaluation studies by April 1, 2011 in consultation with the Association.

(v) Establish and retain a financial management cell in the National Vector Borne

Disease Control (NVBDC) Directorate with at least two financial consultants with qualifications acceptable to the Association through out the project implementation period.

(vi) Establish and retain a procurement cell in the NVBDC Directorate with at least two

procurement consultants with qualifications acceptable to the Association throughout the project implementation period.

(vii) Appoint a consultant as per terms of reference (TOR) acceptable to the Association

to carry out the review of program implementation and fiduciary aspects of selected decentralized activities in the project states and districts.

(viii) GOI will enter into an LOU with states participating in the project inter-alia to

comply with the recording, reporting and review requirements for decentralized activities acceptable to the Association.

(ix) GOI will enter into an Agreement with UNICEF, acceptable to the Association, for

provision of quality polio vaccine in a timely manner.

1

A. STRATEGIC CONTEXT AND RATIONALE 1. Country and sector issues This project introduces important new and more effective measures for the control and management of two serious vector-borne diseases in India: malaria and kala azar. It will assist the Government of India (GOI) to significantly improve key health outcomes for some of India’s poorest people. In doing so, it will incorporate recent agreements and new measures to improve program governance and accountability and implementation effectiveness. Vector-borne diseases (VBDs) are infectious diseases transmitted by mosquitoes and other vectors and are still a significant source of morbidity and mortality in India (see Annex 1a). Among this group of diseases, malaria and kala azar (scientific name visceral leishmaniasis) cause a disproportionately high burden in the tribal populations and the poor. The severe form of falciparum malaria is often fatal and is rapidly increasing in India. This reflects increasing resistance to chloroquine treatment, previously the primary drug. Kala azar, a parasitic infection transmitted by sandflies, occurs mainly among the poorest residing in unhygienic housing. It requires effective treatment and is often fatal if left untreated or if ineffectively treated. About 90% of the reported 2 million malaria cases in India are from 11 states while practically all 40,000 new kala azar cases reported every year are from the states of Bihar, Jharkhand and West Bengal. For both diseases, Indoor Residual Spray (IRS) continues to be the main prevention strategy for vector control. Studies show operational problems with IRS practices, leading to poor coverage and quality, and resulting in ineffective vector control as well as environmental concerns. India’s National Health Policy (2002) calls for reducing mortality from malaria by 50 percent and eliminating kala azar by 2010. GOI has formulated a significantly strengthened program to achieve these goals, which will be supported through this proposed project. The program addresses technical and implementation deficiencies and focuses attention on the endemic states and poor and tribal communities. Reforms include use of new treatment policies and technologies such as Artemisinin Combination Therapy (ACT) for malaria and oral Miltefosine for kala azar, rapid diagnostic tests (RDT) that can be used at village level and integrated vector management (IVM) along with Long Lasting Insecticidal Nets (LLINs). These strategies are congruent with the latest WHO global recommendations and offer the possibility of dramatically improved outcomes for the two diseases. Reforms are also in place or underway to address governance issues to strengthen accountability and outcomes. Table 1 contrasts past and future strategies addressed by these reforms. Table 1: Technical Innovations in VBD Program and Challenges

Intervention, Current Status Agreed Change in Policy/Program Comments/Challenges Malaria Case Management � Presumptive chloroquine treatment no longer effective for increasing falciparum malaria (Pf) prevalence

� Confirmed Pf cases to be treated with ACT, a new, highly effective drug regimen � Rapid diagnostic test kits to be

� ACT treatment requires new training and supervision � Higher commodity costs � Need to assure adequate supply and storage in remote areas

2

� Community-level diagnosis based on microscopy not available or delayed in rural and tribal areas

introduced at community level and used to confirm Pf within 24 hours of first contact.

� Need to assure quality of drugs and medical supplies in booming global market

Malaria Vector Control � Mosquito control traditionally with insecticide spraying in houses (IRS). Effectiveness has declined due to vector resistance

� Program will replace over time most IRS with use of long-lasting insecticidal mosquito bed nets (LLIN). Delivery free to villagers.

� LLINs not yet widely accepted by beneficiaries – need strong behavior change activities � LLIN production in India still limited. Need to develop market

Kala Azar Case Management � Rapidly increasing resistance to currently used injectable medicines for kala azar which also have significant side effects � Current tests to diagnose kala azar are not very specific

� New oral drug – Miltefosine – which is safer and more effective to be introduced in districts where there is high resistance to current drugs. � New Rapid Diagnostic Test (RDT) for kala azar test kits to be used to improve diagnosis � Successful strategies from the TB program to be used to increase patient compliance

� New strategies will require better implementation in some of India’s weakest districts � Miltefosine must be closely monitored as it is toxic to pregnant women and small children � Adequate supplies and logistics must be assured in difficult to reach areas � New technologies are higher cost and may result in low quality imitators which must be kept away from program.

Kala Azar Vector Control � Kala azar vector, the sandfly, now poorly controlled with DDT

� DDT application to be strengthened with new approaches for identifying high prevalence areas. � Training and supervision of control workers to be improved. � Collaboration with local housing and sanitation programs to be increased.

� New strategies require additional staff support and better monitoring and supervision in locations with limited capacity.

Overall Program Management � Current program implemented in many states � Widespread implementation with little attention to capacity or preparation � Weak monitoring � Slow introduction of expert advice

� Project will focus on states with more affected districts � Project will introduce district level readiness filters prior to implementation � Strengthened HMIS plus focused sample and survey reviews � Biannual technical reviews.

� New processes need to be scaled up. Project will expand in two phases with major progress review before two years. � Additional staff support needed for implementation. Project will finance local staff, mobility, and training which will eventually be adopted into the government system.

Previously, successful disease control programs in India such as those addressing tuberculosis and leprosy (both IDA supported), show that large scale results are possible. Reforms in VBD control are also being supported by health systems strengthening initiatives such as those under the National Rural Health Mission (NRHM)1. Moreover, GOI has made a public commitment to

1 The NRHM seeks to provide effective health care for rural population through strengthening public health systems, integrating ongoing vertical health programs and improving cross sectoral collaboration and community ownership.

3

increase government health expenditure from 1% of GDP to 2-3%. The last three annual budgets have seen large increases in central government health financing, including for VBD control (in real terms the total expenditure on VBD control increased by 170% between 1997/98 and 2007/08). Expenditures under the 11th Five-Year Plan are projected to continue this trend. National programs are increasingly making use of flexible funding, local planning, and community involvement to improve effectiveness. This project incorporates some of these approaches such as district level planning for VBD control. The recent India Detailed Implementation Review (DIR) by IDA’s Department of Institutional Integrity identified weaknesses in fiduciary arrangements of the earlier malaria control project supported by IDA. NRHM is strengthening fiduciary systems in centrally sponsored health projects at national, state and district levels. A comprehensive joint action plan has been agreed upon by GOI and IDA to improve fiduciary systems in the sector, and forms the basis for the project’s proposed procurement and financial management arrangements. The project will use these agreed safeguards on central-level expenditures (85% of the total project cost) and introduce new measures for fiduciary assurance for local contractual staff and operating costs (15% of the total) including integrated fiduciary and implementation reviews (see Annex 7). Many persons suffering from fever seek treatment in the private sector; in Orissa, for example, about 50 percent see a private provider. There is no regulation of malaria or kala azar diagnosis and treatment in the private sector and service quality is generally poor. Inappropriate private services increase disease and financial burden especially for the poor and may threaten the long term efficacy of new technologies. Staff shortages in VBD control programs are widespread including 50% for malaria control workers, and IRS staff is seasonal and their supervision weak. There is scope for improvement in management and standard protocols or checklists for supportive supervision at all levels. Operational guidelines, procedures, facilities and systems for safe distribution, storage and disposal of public health pesticides and insecticides need to be improved. Skills in medical entomology, pesticide management and application methods required for a multi-disease program can be further improved. Attention is needed to management of unhygienic and unsanitary land and water environment, and to changes in environmental eco-systems. Behavior Change Communication (BCC) requires greater emphasis, including clear objectives and evaluation of media and messages. Remote and backward areas need special attention. The defined international goals of Polio Eradication are: (i) no cases of clinical poliomyelitis associated with wild poliovirus; and (ii) no wild poliovirus found worldwide despite intensive efforts to do so. A country or region is certified as polio free when the Regional or Global Certification Committee of independent experts has certified that the country/region has had no case of polio from wild polio virus for three years and that good surveillance has been carried out. India joined the global polio eradication efforts in 1995 by starting the National Immunization Days (NIDs) and IDA has been supporting the polio eradication activities in India since 1999.

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India’s polio eradication effort progressed well until it suffered a set-back in 2002 with a major increase of polio cases in the state of Uttar Pradesh. This placed a substantial financial burden on the country due to steeply increased operational and vaccine costs. GOI has been providing significant domestic resources for the polio eradication efforts and IDA responded to this urgent need through re-allocation of credit proceeds (US$96 million) from five health projects as well as providing US$40 million through the second Reproductive and Child Health Project (RCH II). In spite of this, the May 2008 India Expert Advisory Group (IEAG) for polio still identified a substantial financing gap and expressed serious concerns about vaccine security. During National and Sub-National Immunization Days, which are the cornerstones of the eradication efforts, India reaches more than 170 million children. With limited world production of polio vaccine, the lack of multi-year secured financing makes it difficult for GOI to ensure adequate vaccine supplies. The IEAG noted this problem as an important risk to polio eradiation in India and the world and recommended that secure financing will allow multi-year polio vaccine procurement. As the polio epidemiology is rapidly evolving, and as the number of incident cases and consequent additional mop-up operations are unknown, the vaccine needs for the program are not fully predictable and will change over time. Therefore, the program now requires more flexibility in using different types of oral polio vaccines and the ability to purchase additional vaccine at short notice, depending on the local epidemiology and characteristics of the virus (see details in Annex 1B). 2. Rationale for Bank involvement GOI has developed new policies for VBD control incorporating the latest evidence based prevention, diagnosis and treatment approaches, introducing new malaria diagnosis and treatment strategies, new diagnostic technology and drugs to treat kala azar. In real terms the total expenditure on VBD control has increased by 170% since 1997/98 and 2007-08. IDA has been assisting GOI in developing effective infectious disease control programs for over a decade. A Malaria Control Project, partially funded by IDA, was implemented in selected districts from 1997 to 2005.2 The project’s Implementation Completion Report highlighted the need for major reform in technical content as well as implementation arrangements. The improved National Vector Borne Disease Control Program (NVBDCP) is expected to have a significant additional impact on these diseases. An IDA-assisted project, with clear performance indicators, coordinated partnerships, and strengthened monitoring and evaluation mechanisms, will provide strong support to help carry through these changes and complement government investments. IDA support may be particularly valuable in the “software” elements of the project – capacity building, policy development, management strengthening etc. rather than the more traditional roles of commodity supply although these will not comprise most of the actual expenditure proposed. IDA’s Country Strategy (CAS) for India 2005-08 identifies the control and, when feasible, the elimination of infectious diseases as a priority for IDA assistance, and notes its importance for the poor who are disproportionately affected by such diseases.3 The project is also aligned with the Bank-wide commitment to malaria control, as adopted in the Bank’s Global Strategy and Malaria Control Booster Program in 2005.

2 IDA Credit No. 29640, approved on June 12,1997 3 Country Strategy for India 2005-08, World Bank, September 2004, pages 40-41.

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Through provision of financial security for the multi-year purchase of polio vaccine, IDA will make a major contribution to the eradication of polio from India, and, with India being one of only four polio endemic countries left in the world4, thereby contributing to global polio eradication. This project is also the first centrally sponsored health operation following the DIR, and is in conformity with the actions agreed under the joint action plan between the Ministry of Health and Family Welfare (MOHFW) and IDA. 3. Higher level objectives to which the project contributes The proposed operation will help reduce morbidity and mortality from malaria and kala azar which account for a significant disease burden and economic loss in India, especially among the poor. The project is an investment in strengthening the health system. The reduced burden of malaria will contribute to the achievement of the millennium development goals (MDGs) by lowering malaria incidence and mortality and by contributing to lower child and maternal mortality and poverty reduction among remote, rural and tribal populations. The provision of secure and flexible financing for polio vaccines will contribute to the achievement of the global polio eradication goal. B. PROJECT DESCRIPTION 1. Lending instrument The lending instrument will be a Sector Investment Loan (SIL). Major policy reforms supported by the project include strengthened policies for malaria and kala azar diagnosis and treatment and introduction of LLINs. The SIL will also support front-line service delivery institutions over the project period. It will strengthen the borrower’s institutions and capacity in planning, implementing and monitoring of vector borne diseases control at all levels and enhance coordination among major donors and technical agencies. 2. Project development objective and key indicators The Project Development Objective (PDO) is to enhance the effectiveness of government response to control malaria, eliminate kala azar and eradicate polio. This will be achieved by an increase in the number of people benefiting from effective prevention, diagnosis and treatment services for malaria and kala azar, and vaccination against polio. Project success will be measured in the project districts through such indicators as percentage of (i) fever cases receiving a malaria test no later than the day after the first contact and, if Pf positive, treated with ACT; (ii) targeted individuals reporting that the LLINs were used the previous night; (iii) blocks achieving the elimination goal of less than one kala azar case per 10,000 persons; and (iv) eligible households reached with polio vaccine during national and sub

4 India, Pakistan, Afghanistan, Nigeria

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national immunization days. The PDO indicators, with their baseline values, targets, and measurement methodologies are detailed in Annex 3. 3. Project Components and Sub-Components The project will have four components: (1) Improving access to and use of malaria prevention and control services; (2) Improving access to and use of services for the elimination of kala azar; (3) Policy and strategy development, capacity building and monitoring and evaluation; and (4) Supply of polio vaccine. A detailed project description is provided in Annex 4 and a summary follows below. Components 1 and 2 mainly contain the material and commodity support for the project. Component 3 contains inputs to strengthen management support and Component 4, supply of polio vaccine. The project design incorporates the recommendations of the Quality Enhancement Review (QER) to focus on two priority diseases, and to implement scale-up phases with the Early Implementation Review. Project Component 1: Improving Access to and Use of Malaria Prevention and Control Services [US$119.5 million] This component will finance pharmaceuticals, diagnostic kits, laboratory consumables, insecticides, LLINs, laboratory equipment, computers and software, furniture, training and Information Education Communication (IEC)/BCC materials. Ninety three highly endemic districts will be targeted in eight states. There are three sub-components. Sub-Component 1a: Improving Malaria Case Management: During the first two years, the new malaria case management policy will be implemented in 50 prioritized high Pf burden districts in the states of Andhra Pradesh, Chhattisgarh, Jharkhand, Madhya Pradesh and Orissa, and an effective implementation model developed. Support for supervision and integrated vector control will be provided to the other 43 project districts as well. Readiness criteria (see Annex 6) will be used to assess the district preparedness to implement the new policy. Subject to a satisfactory implementation review 18 to 21 months into project implementation, the new model will be expanded to the remaining project districts. Sub-Component 1b: Strengthening Malaria Surveillance: The project will de-emphasize the collection of blood samples through outreach workers, i.e., Active Case Detection (ACD) as a mechanism for disease surveillance. Instead, surveillance will be primarily based on the examination of blood samples from suspected malaria cases, i.e., Passive Case Detection (PCD). The project will support the introduction of a sentinel surveillance system for PCD, for monitoring hospital admissions and deaths attributable to malaria at selected representative sites in the public and private sector. It will support periodic surveys of health facilities and households in endemic areas. It will also collaborate with the Integrated Disease Surveillance Project on fever surveillance. Sub-Component 1c: Effective Vector Control: Micro-stratification of project districts, based on epidemiological and ecological data, will be introduced, including delimiting areas and populations for selected interventions, i.e., IRS or ITNs. The use of IRS will be restricted to high risk areas where ITNs are unacceptable, or where other evidence exists for superior effectiveness of IRS. The

7

quality of IRS will be improved through better management of resources and capacity building of spray workers. Areas consistently reporting high Annual Parasite Incidence (API) in all age-groups will be given priority for LLINs with a target of 80% coverage. LLINs will be initially piloted in five states. Subject to statutory clearance, LLIN distribution may be expanded using public-private partnerships. Project Component 2: Improving Access to and Use of Services for Elimination of Kala Azar [US$41.9 million] This component will finance supply of RDI for kala azar dipsticks, pharmaceuticals, training, insecticides, BCC materials, equipment, furniture, transport and computers and software. Forty six of the most endemic districts in three states will be targeted. There are three sub-components. Sub-Component 2a: Improving Kala Azar Case Management: During the first year of project implementation, new approaches to case management will be implemented in 16 high-endemicity districts in Bihar, followed by an additional 16 districts in the second year in the states of Bihar, Jharkhand and West Bengal (total of 32). Subject to a satisfactory review, project activities will be scaled up to the remaining 14 districts during the last three years of the project (total of 46 districts). However, management strengthening and social mobilization inputs will be provided to all project districts from the beginning. Project activities will include free diagnosis and treatment by supplying rapid diagnostic kits (RDKs) for kala azar, oral Miltefosine and Paromomycin injections;5 enhanced treatment compliance through the use of treatment cards; training in case management for providers and supervisors; strengthening management at district level; 6 and providing additional supervisory staff at sub-district level. Subcomponent 2b: Strengthening Kala Azar Surveillance: Passive surveillance will be strengthened through capacity development and the use of simple reporting formats. Reporting from the private sector and NGOs will be included. Sentinel surveillance sites will be established to obtain accurate information on severe cases which are hospitalized and the case fatality rates will be calculated. The strategic thrust in active surveillance will be on case detection around the reported cases through active case search. Subcomponent 2c: Effective Vector Control: The IVM approach will be adopted to use the best options to reduce transmission risk and incorporate district based planning. Geographic Information System (GIS) and remote sensing will be introduced to determine IRS coverage. IRS, coupled with effective insecticide aiming for complete and uniform coverage, will be the main trust of IVM. BCC will be used to involve the community. Project Component 3: Policy and Strategy Development, Capacity Building and Monitoring and Evaluation [US$52.1 million] This component will finance equipment, furniture, transport, computers and software, training, supervision, additional contractual staff, operating costs including transport and consultants for both malaria control and kala azar elimination. There are three sub-components.

5. After obtaining the required approvals 6. WHO is providing management support at national and state levels

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Sub-Component 3a: Policy and Strategy Development: The project will complement the TA currently provided through the Global Fund for AIDS, TB and Malaria (GFATM) to the NVBDCP Directorate with consultants in procurement, financial management, M&E, social development and environmental safety. With the combined support, NVBDCP will: (i) update evidence-based policies for VBD control and translate these into operational guidelines and training materials; (ii) improve quality assurance; (iii) support operations research including technology assessment; (iv) undertake impact evaluation; (v) organize periodic external reviews; (vi) monitor drug resistance and insecticide effectiveness; (vii) assess drug quality; and (viii) promote Public Private Partnerships. Sub-Component 3b: Program Management and Capacity Building: This sub-component will include the following activities: (i) engaging additional staff for procurement, financial management, BCC and M&E at the state level; (ii) deploying VBD consultants at the district level and malaria/kala azar technical supervisors (MTS/KATS) at the sub district level; (iii) providing management training to state and district program teams; and (iv) providing supervisors with integrated training in vector management, occupational health and safety and environment management. Sub-Component 3c: Monitoring and Evaluation: This sub-component will support activities to rationalize and improve the computerized management information system (MIS) and make it functional, and M&E related surveys and studies. The existing GIS will be expanded as a tool for micro-stratification, planning, monitoring and advocacy. These activities, including development of an M&E framework and related capacity development, will be implemented by the NVBDCP Directorate. In addition to the project components, approximately US$36.5 million has been included in the project as unallocated funds. These resources will be available to support more rapid scale-up of project interventions such as LLINs, if deemed appropriate. It will also serve as a contingency fund in the event that proposed finances from GFATM are not available and there is an agreement on fiduciary arrangements acceptable to IDA for NGO contracting and PPPs. Project Component 4: Supply of polio vaccine [US$271 million] Polio eradication efforts in India are now at a stage where careful planning of vaccine supplies and effective surveillance with prompt laboratory confirmation of the type of virus causing every single case of polio is critical for better informed decisions on which type of vaccine to use in each national and sub-national round of vaccination. While the program has solid supervision, surveillance and laboratory support systems in place, adequate buffer stocks of vaccines are not available to allow for short term changes in vaccination approach responding to the type of polio virus found and for mop up interventions required following the identification of any new case. Through this financing security provided by IDA, GOI will be in a position to order enough stocks of different types of polio vaccine and undertake urgent additional purchases when required, thereby making appropriate decisions on the type of vaccine to use in each vaccination intervention (see details in Annex 1B and 4).

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4. Lessons learned and reflected in the project design Ownership by the states is essential for success: In the proposed project, the states will play a critical role in reviewing and approving the district plans prepared within the national policy framework of NVBDCP and provide oversight for their implementation under the NRHM. This ensures better ownership and active participation of the states in the project. Identifying and addressing procurement and supply chain problems up-front is critical: The United Nations Office for Project Services (UNOPS) has been contracted to procure pharmaceuticals and other goods under the project until the needed capacity is developed in MOHFW/states or another procurement agent is selected to replace UNOPS. Independent inspection agencies will monitor the quality and quantity of the procured goods. Consultant agencies will be hired to support states in managing supply chain logistics. Strengthening management at the state and district levels is essential for successful decentralization: Additional management support has been provided at district, state and national levels. Meeting the agreed readiness criteria will be mandatory before a district is included under the project. The project includes training and additional supportive supervision for implementing new policies. External reviews and data triangulation are necessary to maintain a program’s credibility: An external review led by WHO was held during project preparation. Two more external reviews are planned. A baseline household and facility survey has been conducted and two additional rounds are planned. Sentinel surveillance and impact evaluation studies are planned. Innovative approaches to prevention strategies are needed: For IRS, entomological surveillance will be strengthened. Spraying will be limited to populations most in need and supervision enhanced through the provision of trained supervisors at the sub-district level. Strategies to enhance community acceptance of LLINs will be tested in state level pilots as a part of the planned impact evaluation studies and successful models will be scaled up. Monitoring the therapeutic efficacy of anti-malaria medicines and insecticide resistance is essential: The project supports monitoring of therapeutic efficacy at 14 regional centers. The strengthened state entomology units will monitor insecticide resistance following WHO protocols. Both parasite and vector elimination is essential for kala azar elimination: The project includes treatment with new, effective drugs and vector control through coverage of targeted households with effective insecticides supported by IVM and BCC efforts. For polio eradication to succeed the timely availability of quality vaccines is essential. 5. Alternatives considered and reasons for rejection The main alternative considered was a sub-sector program covering all the major VBDs throughout India and the Project Concept Note included this wider scope. This was attractive

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given the economic importance of these diseases, overlapping strategies to address these, the emerging threats and the costly commodities. Malaria and kala azar are far more important than other VBDs as causes of rural poverty. In addition, addressing the two diseases throughout the country was rejected due to the need for phased learning and scale-up of new approaches and the potential for larger, more cost effective results through a more targeted approach. C. IMPLEMENTATION 1. Partnership Arrangements In addition to IDA, the NVBDCP receives direct external funding only from GFATM while WHO provides technical assistance which is partly financed by the GFATM grant. The current GFATM support for malaria, around US$15.0 million/year, has a geographic focus on high malaria burdened North Eastern States, West Bengal, Jharkhand and Orissa. While both IDA and GFATM will be supporting malaria control operations in Jharkhand and Orissa, district level planning will assure coordination and avoid duplication. GFATM and IDA will support malaria control through similar implementation arrangements and common procurement procedures, review mechanisms and M&E framework. Both projects will have a common procurement agent. The GFATM TA to the NVBDCP Directorate through WHO will be used for the entire program. To ensure effective coordination, joint implementation support missions will be undertaken with technical support from WHO. USAID and DFID have state level health systems strengthening projects in three malaria endemic states. DFID is supporting such programs in Madhya Pradesh and Orissa and USAID in Jharkhand. A state level coordination mechanism is proposed in these states to improve coordination between all external development partners working in these states. The importance of private sector services in treatment and control of malaria and kala azar was noted during project preparation and the QER. The government’s NVBDCP will include significant activities to engage NGOs and private providers in service delivery partnerships and efforts to improve private service delivery. IDA financing will support initiatives with the Indian Medical Association and NGOs at national and state level, while GFATM will support district-level NGO’s and community outreach. The project includes contingency financing for lower level innovations with the private sector and NGO partners in case GFATM financing is not approved. The Government will carry out a review of issues related to unregulated use of artemisinin in the private sector and develop plans to address this during the first 6 months of implementation. While the main financiers of the Polio Eradication Program are the central and state governments, substantial contributions have also been provided from a number of Development Partners. GOI and WHO have set up the India National Polio Surveillance Project (NPSP), which employs more than 300 surveillance officers around the country to undertake polio surveillance and also to support training and monitoring during supplemental immunization activities. UNICEF provides country wide support for social mobilization. Financing for both WHO and UNICEF as well as polio vaccine is provided by Kreditanstalt fur Wiederaufbau, Germany (KfW), Center for Disease Control, Atlanta (CDC), Government of Japan, USAID,

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Canadian International Development Assistance (CIDA), DFID, and Rotary International. Technical advice to the program is provided by the IEAG. 2. Institutional and implementation arrangements A. The Vector Borne Disease Component The proposed institutional arrangements are based on the implementation experience of the IDA-supported Malaria Control Project, institutional assessments undertaken by GOI and IDA, the GOI-Bank Joint Action Plan in response to the India DIR. Institutional strengthening is proposed at the central, state and district levels to address both operational and fiduciary concerns. The Governance and Accountability Action Plan (GAAP, see Annex 9) contains specific provisions to improve procurement at central level, financial management, and overall accountability. The project will be implemented within GOI’s NRHM framework which is providing complementary investments to improve general health services and administrative systems. Central Level: Overall project responsibility will rest with GOI through the NVBDCP Directorate of MOHFW. The Directorate’s existing structures will implement the project; additionally, the project will provide one to two consultants each in strategic planning, BCC, procurement, financial management, social development, environment management, entomology and M&E. The Directorate will hire these consultants to be in place by project effectiveness. Most of the project procurement will be handled by UNOPS which is currently contracted by MOHFW as a procurement agent, or by a future procurement agent selected through a competitive process. An advisory group chaired by the Indian Council of Medical Research (ICMR) will review the operational research and impact evaluation findings and recommend policy changes. The project will provide specific inputs to strengthen monitoring of therapeutic efficacy of anti-malaria/kala azar drugs, pharmaco-vigilance, vector resistance and quality of diagnosis and medicines.

State Level: The state NVBDCP officer will be responsible for the project and will report to the Director, State Health Services. Project funds will flow through integrated state health societies. A support unit, with a consultant in each of the areas of M&E, social development, environment management, financial management and procurement in endemic states, will assist the state NVBDCP officer. The respective state departments of health will hire these consultants to be in place by project effectiveness. WHO is supporting a dedicated program manager for each kala azar endemic state. District and Block Level: The project will provide to the VBD endemic districts an additional program manager and up to six MTS/KATS to improve on-the-ground quality and effectiveness. The project will also support sentinel surveillance for monitoring incidence and occurrence of severe cases and deaths due to VBDs. For improved oversight, the project will support additional mobility for program managers and supervisors. Village Level: Under NRHM, India has introduced a new village worker, the Accredited Social Health Activist (ASHA), and aims to strengthen village level health action through the provision of untied grants and development of local committees. A key innovation in the project will be to

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bring VBD rapid diagnosis and treatment to the community level building on these initiatives through increased training, supervision and supplies. B. The Polio Component Overall responsibility for project implementation will rest with GOI through MOHFW. The existing structures will implement the project. Support and technical assistance for monitoring, surveillance, training and the laboratory network will be provided by WHO through the NPSP while social mobilization will be supported by UNICEF. Vaccine will be purchased by MOHFW through UNICEF. An advisory group, the IEAG, regularly provides advice on programmatic issues based on the epidemiology of the disease and the latest laboratory findings of the typology of the polio virus from active cases.

3. Monitoring and evaluation of outcomes/results A. The Vector Borne Disease Component The NVBDCP Directorate will be responsible for monitoring and evaluation. The project will support NVBDCP’s increasing results orientation and systems to measure outcomes. This involves triangulating data from different sources, verification by periodic household surveys (baseline, mid-line and end-line) by ICMR’s respective institutions, and program impact evaluation. The project’s results framework (Annex 3) details the key targets and indicators. Monthly, quarterly and six-monthly reviews will be held at the district, state and national levels, respectively. These will be supplemented by systematic visits by NVBDCP officers and regional directors; mid and end line reviews by independent experts; and mid and end line household and health facility surveys. A household and facility survey was conducted during preparation and its report is available. Additional baseline data on key indicators will be collected during the first six months of implementation to meet the IDA requirement. An impact evaluation is planned to assess the cost-effectiveness of different service delivery options such as intensified case management and alternative LLIN distribution mechanisms. The pilot interventions will be implemented in two districts purposively sampled from the 50 Pf endemic districts. Details are in Annex 4. The above efforts will contribute to timely changes in policies and to solving operational problems. For implementing M&E, the project will provide human resources and training to build district level M&E capacity. The tools, including standardized forms and records to track stocks, storage, distribution and use of commodities are being developed and field-tested by NVBDCP together with the States. B. The Polio Component The India polio eradication program has put in a very effective system of monitoring and surveillance over the past decade. During every national and sub-national immunization round, teams of external monitors and NPSP staff closely monitor the vaccine coverage of eligible children covering around 1% of households. The polio surveillance system in India uses global

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standard indicators for incidence of acute flaccid paralysis cases among children aged below 15 years and for timely collection of stool samples (see details in Annexes 1b and 3). 4. Sustainability The NVBDCP is a part of the NRHM, and it appears as such in the budget of the MOHFW. The NRHM is a high-priority GOI program. The 11th Five Year Plan (2007-08 to 2011-12) ceiling for the NVBDCP has been fixed at Rs. 31903 million. This amount is significantly higher than what was allocated in the 10th Five Year Plan (Rs. 14,700 million). A substantial part of the 11th Plan allocation to the NVBDCP (71.7%) will be financed by GOI and the external aid will account for only 28.3%. IDA and GFATM are the only two external donor agencies financing this program. Of the total external aid, IDA will contribute a major part (77.8% or Rs. 7,040 million) over the next 4 years. The key constraint for the NVBDCP during the 11th Plan may not be the availability of funding, but the lack of qualified human resources at all levels with the ability to implement and monitor the program. Recognizing this, GOI has approved funding of Rs. 2,450 million (or US$61.25 million) for additional human resources for the next 4 years. Sustaining the cost of additional human resources and other capacity building initiatives (captured in the project Component 3) beyond the project life should not pose a significant problem, given the dominant share of GOI funding to the program and the fact that GOI is committed to doubling or even trebling public health expenditure by the end of the 11th plan period. 5. Critical risks and possible controversial aspects:

Risks Risk Mitigation Measures Ratings after

Mitigation To project development objectives New malaria case management policy does not have well-established implementation models. Continuation of old treatment policies in non project areas poses a reputational risk to the Bank.

The project includes a phased implementation approach with expansion subject to early implementation review. Covenants will assure compliance to policy changes committed by GOI.

S

Procurement weaknesses including delayed decision making, quality concerns and lack of competition and possibility of collusion, may undermine procurement and implementation at central level.

The GAAP will help mitigate the identified risks. UNOPS or a qualified procurement agency will initially handle all significant procurement relating to the project. Additional capacity at central and state levels will ensure effective procurement management and supply chain logistics.

S

Hiring management staff for strengthening different levels may be delayed due to

Hiring contractual staff and support from WHO will be financed under GFATM. Additional staff positions created under the

S

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procedural difficulties. NRHM will ensure sustainability. District and sub district contracted staff are approved and will be in position for Year 1 districts for eligibility for program implementation.

To component results States’ commitment to control VBDs may remain weak and field staff vacancies may impede implementation.

States and districts will prepare their own evidence-based plans to address their specific needs. Support under the NRHM is also available for critical staff positions. Districts must meet readiness criteria to be eligible for project inputs.

S

The budget provision for NVBDCP may not match the project requirements and fund releases to states and districts may be delayed.

The GOI has publically committed to raise the allocations to the health sector during the 11th Plan period. Strengthened financial management under NRHM will facilitate timely release of funds.

M

The states and districts may fail to plan to meet the special needs of the poor and tribal populations, or may fail to implement interventions needed to address them.

A participatory Vulnerable Communities Plan has been prepared to guide states to plan and implement interventions. Technical support will be provided for development of locally specific action plans and their implementation in a phased manner.

M

The program may fail to adequately implement safeguard measures with regard to insecticide management and use, which could have adverse impacts on environment and public health

An Environmental Management Plan (EMP) has been developed for capacity building, implementation of guidelines of good practices for insecticide use and management and integrated vector management. Its monitoring will be built in supervision process. Additional consultant support proposed to help implementation of the EMP.

M

New monitoring arrangements for decentralized contractual staff and operating costs may not assure adequate control over risks.

Performance will be reviewed based on the results of the integrated implementation and fiduciary review and using both program and independently collected data. The arrangements will be redesigned, if necessary, during the early implementation review.

M

Civil unrest in some project areas may adversely affect implementation due to staff shortages and supply problems. Supervision may be periodically difficult.

Ongoing programs are being implemented even in difficult areas. Governments should be required to maintain program data. Supervision will be done when possible.

S

Use of substandard vaccine or stock outs of vaccine will substantially reduce the effectiveness of the Polio

With long term financial security for vaccine purchase and procurement through UNICEF, vaccine will be provided in a timely manner and only from WHO pre-qualified/approved

L

15

Eradication efforts at national and global level

producers

Overall risk rating: S H= High S = Substantial M = Moderate L = Low 6. Loan/credit conditions and covenants: Covenants applicable to project implementation:

The GOI will:

(i) Provide an annual update on progress made in the implementation of evidence based policies (see Table 1) supported by the project by February 1 of each year;

(ii) Ensure timely availability of project inputs to the project districts as per the

agreed phasing plan;

(iii) Complete, not later than six months after project effectiveness, baseline surveys measuring key project indicators using a methodology acceptable to the Association.

(iv) Finalize the design of evaluation studies (see Annex 4) within 6 months of project

effectiveness, start implementing the initial round of evaluation studies from August 1, 2009 and, based on the lessons learnt, finalize the design for scaling up improved practices based on evaluation studies by April 1, 2011 in consultation with the Association.

(v) Establish and retain a financial management cell in the NVBDC Directorate with

at least two financial consultants with qualifications acceptable to the Association through out the project implementation period.

(vi) Establish and retain a procurement cell in the NVBDCP Directorate with at least

two procurement consultants with qualifications acceptable to the Association through out the project implementation period.

(vii) Appoint a consultant as per TOR acceptable to the Association to carry out the

review of program implementation and fiduciary aspects of selected decentralized activities in the project states and districts.

(viii) GOI will enter into an LOU with states participating in the project inter-alia to

comply with the recording, reporting and review requirements for decentralized activities acceptable to the Association.

(ix) GOI will enter into an Agreement with UNICEF, acceptable to the Association,

for the provision of quality polio vaccines in a timely manner.

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D. APPRAISAL SUMMARY 1. Economic and financial analyses A. The Vector Borne Disease Component Available evidence suggests that malaria interventions supported by the project are highly cost-effective using a cutoff of US$150 per Disability Adjusted Life Year (DALY) averted.7 There are two broad types of interventions in malaria control: prevention and case management. On the prevention side a review of worldwide trials of insecticide-treated nets (ITNs) and IRS reports that ITNs and Indoor Residual Spray (IRS) have equival effectiveness.8 On case management, the project supports a shift from the current presumptive treatment with chloroquine to treating all confirmed P. falciparum malaria cases with Artemisinen-derivative Combination Therapy (ACT). A review of international evidence suggests that a switch from chloroquine to ACT is highly cost-effective at all initial levels of chloroquine resistance above 37 percent. However, this analysis does not take into account non-health benefits or the costs of health systems strengthening required to make effective use of ACT. Inclusion of non-health benefits alone such as the significant economic cost to families of malaria increases the attractiveness of switching to ACT. The health systems strengthening costs are largely coming from the NRHM; additional system strengthening costs should be relatively low. An assessment of cost-effectiveness of introducing ACT in India suggests that the unit cost of diagnosis and treatment under the new policy will be over ten-fold higher than that of the current policy (Rs. 7.5 vs Rs. 77.8). However, additional benefits accrue in reduced disease transmission and mortality. Steeply reduced hospitalizations, mortality and transmission (as seen elsewhere in the world) will more than compensate for the initial steep increase in costs. The new policy will only be 52% more expensive than the current policy (Rs. 1073 million vs. Rs. 1633 million in100 districts), but will avert an estimated 66,000 hospitalizations and 13,200 deaths (Annex 10) suggesting the project is economically justified. Kala azar is one of the most neglected diseases in the world, affecting the poorest segments of rural populations in southern Asia, eastern Africa, and Brazil (Yamey and Torreele 2002).9 In India, kala azar is confined mainly to 52 districts across 4 states of India. In 2006, around 39,000 kala azar cases were reported in the country. This is believed to be substantial under-reporting of the actual incidence. With effective case management it is possible to eliminate kala azar, and case management is more cost-effective than vector control. Recent studies10 show kala azar treatment to be extremely cost-effective as it costs US$315 per death averted and US$9 per DALY gained.11

7 Breman, J.G. et al, Conquering malaria, Chapter 21 in Disease Control Priorities in Developing Countries 2006, pages 413-432. 8 For more empirical evidence on the cost-effectiveness of malaria interventions see Annex 10. 9 Yamey G, Torreele E., (2002). The world’s most neglected diseases. BMJ 325: 176-177. 10 For example, Laxminarayan, R., et al, Intervention Cost-effectiveness: Overview of Main Messages, Chapter 2 in Disease Control Priorities in Developing Countries 2006, pages 35-86. 11 One DALY (Disability-Adjusted Life Year) represents a lost year of healthy life due to poor health or disability and potential years of life lost due to premature death.

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B. The Polio Component Using standard public finance criteria, public financing of polio eradication efforts is well justified. Control of an infectious disease is an example of a public good for health with high externalities. As eradication of polio is a global public good there are strong arguments for international financing. SIAs will end with polio eradication and there will be no need to sustain these. Polio eradication benefits are infinite because the disease will be extinct, unless a man-made mistake or disaster makes it reappear. If eradication is delayed and additional financing is required, it is most likely to be supported by the development partners and technical agencies who are fully committed to eradicate the disease in India and globally. Financial Analysis For the Vector Borne Disease Component the proposed IDA support will provide around Rs. 8,000 million over a 5-year period (about Rs. 1,600 million each year) to GOI. This is around 25% of the overall NVBDCP budget allocations. During the last 11 years (1997-98 to 2007-08), the annual expenditure incurred by the NVBDCP has gone up by 170%. Being an integral part of the NRHM, the VBDCP is expected to benefit from the substantial increases in NRHM budget allocations as a part of overall commitment made by GOI to raise public expenditure on health from 1% of GDP to 2-3% (See Annex 10). With increasing financial commitment of GOI to the health sector, no central program is expected to be deprived of funds necessary for improving program performance. Phased introduction of new, expensive technology, management strengthening at central, state, district and sub-district levels, and procurement through UNOPS or another qualified procurement agent will help achieve effective use of funds. For the Polio Component the proposed IDA credit will provide financing for polio vaccine for the years 2008 – 2011; for year 2008 part of the vaccine costs will be met by KfW. This is around 40% of total program cost. 2. Technical The proposed interventions for malaria and kala azar case management and vector control are technically sound and are recommended by WHO based on global evidence. Participation by national and international experts and senior WHO staff in project preparation has confirmed this technical soundness. The project design emphasizes increased community level access to improved diagnosis, treatment and prevention using village-based health workers and institutions. However, implementation of these interventions is based on two important assumptions. First, the general health services and large cadre of village based volunteer providers will develop adequate competencies and will be adequately motivated and supported to effectively deliver these services. Second, there will be a consistent supply of quality assured

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pharmaceuticals, test kits and LLINs. While improved diagnosis and effective treatment are expected to enhance use of the public sector, the private health providers, both formal and informal, will continue to play an important role in the treatment of malaria and kala azar. The project will support measures to address the private sector role and include measures supported by others. The project is focused on a manageable number of areas with high disease burden. Three initial year 1 districts are ready for implementation. The remaining year 1 districts for malaria and kala azar are completing recruitment, training and supplies and are expected to be ready by effectiveness. Scale-up is phased appropriately. The program review in the first two years offers sufficient opportunity to correct deficiencies before further scale-up. The proposed new cadre of dedicated supervisors at sub-district level should enhance supportive supervision and sustain the motivation of the general health staff. Strategic review and response will be assured through adequate technical oversight by the Directorate of NVBDCP using innovative data collection and rapid assessments together with bi-annual comprehensive technical reviews by WHO. In light of the importance of private providers in VBD control and prevention, the IDA project will consider financing PPPs based on lessons learnt from GFATM-financed pilots. Malaria: To monitor potential resistance to the partner-drug (sulfadoxine-pyrimethamine) in the ACT currently approved in India, a nation-wide sub-project for monitoring resistance is included in the project. The data will be reviewed annually by the Ministry of Health Technical Advisory Committee and WHO experts to ensure prompt policy response. Quality assurance for RDK is also important, as these require proper storage and precise logistics. In view of several serious weaknesses of IRS, the promotion of LLINs has been identified as the main method of vector control. This requires locally adapted BCC programs and stringent logistics, accounting and monitoring of adequate use. Insecticide resistance monitoring is also essential and included in the project. Only one LLIN product is registered in India, but the availability of LLINs is likely to improve in the near future. Kala azar: Timely and effective implementation of technical interventions proposed under the project is necessary for India to achieve its kala azar elimination goal. The program follows WHO recommendations of using the simple ‘Rapid Diagnostic Test for Kala azar’ test for diagnosis, Miltefosine - an effective, relatively safe oral drug - as first-line drug and Amphotericin B or Liposomal Amphotercin as the rescue drug. New drugs may need to be introduced over time, such as Paromomycin. The efficacy of currently used drugs will be sustained through monitoring of drug resistance and quality assurance. Milteofsine should not be used in pregnant women and by women in reproductive age not on contraceptives. All service providers should be thoroughly informed about this risk. As all these drugs require 3-4 weeks of treatment, the kala azar elimination program is building on successful lessons from the TB Directly Observed TB Treatment, Short Term (DOTS) program like directly observed treatment and use of treatment cards to ensure completion of treatment. Polio: Timely supply of quality polio vaccine is essential to achieve polio eradication. It is expected that the last case of type 1 polio may occur this year; this presents a possibility to fully

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concentrate on type 3 polio which could then be eliminated by the end of 2009. This will however require timely availability of quality vaccines for SIAs and high coverage of eligible children through well organized campaigns. 3. Fiduciary Financial Management 3A. TheVector Borne Disease Component This is a follow-on project to the Malaria Control Project (Cr. 2964-IN) closed in December 2005. The lessons from the earlier project and other IDA-supported centrally sponsored health programs suggest the need to strengthen the financial management arrangements at the State and district levels, especially internal controls. With the launch of NRHM, MOHFW is working on integration of operational and financial management arrangements including funds flow for all disease control programs at the state and district level. As part of this process MOHFW has facilitated the recruitment of finance staff at state, district and block levels, developing an integrated financial management manual and is strengthening the audit assurance process for the decentralized units. The Directorate, NVBDCP will be the implementing agency for the malaria and kala azar component of the project. Under this component of the project, 85% of the expenditures will be incurred at the central level, of which a significant part will be carried out by an independent procurement agent. The expenditure at the decentralized level to be financed under the project will be limited to contractual staff, mobility cost of various staff and training, which is estimated at US$37 million at an average of US$85,000 per district per year. While the audit assurance for the expenditures at the central level will be obtained by annual audit reports by the Comptroller and Auditor General, the assurance for decentralized expenditures will be obtained by an integrated implementation and fiduciary review of a sample of districts. This will be carried out by an independent consultant to be appointed by MOHFW as per TOR acceptable to the association. The disbursement will be on an annual basis by way of interim financial reports: (a) for Central Level: the actual expenditures incurred and reported, including those incurred by the procurement agent and (b) for Decentralized Expenditures: the transfer to the states on the basis of cost determined by applying the standard costs for the activities to be financed by IDA. On the basis of the findings of the implementation and fiduciary review of selected activities and a comparison of the actual cost with standard cost, the need for redesigning the arrangements as well as revising the standard costs, if any, will be assessed at the time of the early implementation review i.e. after 18 months of project effectiveness. Retroactive Financing: The project has initiated agreed preparatory activities at the central level and procurement of drugs and insecticides through UNOPS. Therefore retroactive financing of central level expenditures on procurement will be provided subject to a limit of US$10 million. These will be claimed by the project as part of the financial report for the year 2008-09.

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3B. The Polio Component The earlier Immunization Strengthening Project (Cr. 3340-IN) funded by IDA closed in December 2005. A main factor in this project that ensured availability of polio vaccine was that it was procured and supplied by UNICEF. A significant part of the funds utilized (over 75%) were advanced to UNICEF for procurement of vaccination and quarterly financial reports on funds utilization were received on a regular and timely basis. The project however faced delays in submission of audit reports from the states for the operational expenses on a regular basis leading to suspension of disbursement in one instance. Because multiple donors were financing the same set of activities, the program had the flexibility to charge expenses to various donors (based on annual grant availability) and ensure a continuous flow of funds to the states. The polio component of this Credit, which will be implemented by MOHFW, will support a single activity, i.e. purchase of polio vaccines. The requirement of polio vaccines for SIAs will be procured by MOHFW from UNICEF acting as the supplier. Upon recommendation from MOHFW, IDA will make direct payments to UNICEF with information to MOHFW. UNICEF will open a separate sub-ledger account for this purpose in its books of account. MOHFW will maintain inventory records in respect of vaccines ordered and delivered. MOHFW will obtain from UNICEF and provide to IDA a quarterly report. UNICEF will also provide to IDA and copy to MOHFW a statement of funds received from IDA and payments made from IDA sources on a quarterly basis in the agreed formats. The project will rely on UNICEF’s internal controls on use of funds, procurement of vaccines and utilization thereof and an exemption to receive audit report for this component of the project has been received from IDA’s Financial Management and Operations Review Committee. For details of financial management arrangements refer to Annex 7. Procurement A. The Vector Borne Disease Component This is a procurement-intensive component with about 80% of the expenditure to be incurred on procurement. All ICB and NCB procurement above US$100,000 will initially be handled at the national level only through the procurement agent UNOPS, which is currently working as the procurement agent for the sub-project, (or its successor to be selected internationally through a competitive process). The procurement of services (both consultancy and non-consultancy) will also be supported by an appropriate agency acceptable to IDA until the implementing agencies fully develop their in-house capacity. The role of such agency will be limited up to finalizing the contract award recommendations, while MOHFW will provide technical inputs for selection and will be signing and managing service contracts. The NRHM of GOI envisions the decentralization of the health sector procurement to the states. This is important from the sustainability perspective and use of the procurement agent, as described above, is envisaged as a temporary measure. IDA is currently working with MOHFW

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and DfID to assess the procurement capacities of selected state level procurement agencies based on accepted standards for health sector procurement including having adequate systems and procedures, internal controls etc. Based on this assessment, a plan will be developed for strengthening the capacity in identified areas of weakness, which is likely to be financed by DfID through technical assistance. Following this process, these state level agencies could be entrusted with the responsibility to handle procurement under the sub-project at the decentralized level. IDA along with DFID is working on capacity building of the Empowered Procurement Wing (EPW) of the MOHFW, which has been set up to professionalize the procurement of health sector goods and services under centrally sponsored health programs. With most of the procurement to be initially handled by the procurement agent, the role of the NVBDCP Directorate will be to directly handle low value procurement (below US$100,000), coordinate with the procurement agent, monitor the stock position and quality of supplies; develop specifications, supply chain management, quality management, procurement planning, implementation of risk mitigation plan and service procurement (as and when capacity is built up for this), monitor the decentralized procurement (as and when allowed) etc. For playing these roles effectively, the NVBDCP Directorate has recruited two consultants (one under GFATM funding and another under the sub-project), while one more consultant is likely to be in place within three months of effectiveness of the credit. To mitigate the procurement related risks noticed in the DIR, GOI and IDA have prepared a joint action plan. This plus additional governance measures based on previous reviews are captured in the GAAP. The overall procurement related risk for the sub-project is determined to be “Substantial” because of the risk of fraud and corruption in procurement transactions (low probability but high impact) and other risk factors mentioned in Annex 8. Some advance contracting under the sub-project has already taken place. MOHFW has prepared the procurement plan for ICB/NCB procurement and major consultancies to be taken up during the first 18 months of the sub-project, which will be updated on an annual basis. The prior review thresholds will also be reviewed on an annual basis and will be adjusted based on risk assessment of the implementing agencies. The contracts which are not subject to prior reviewed will be covered under IDA ex-post reviews. The procurement audits to be conducted by the Borrower will supplement IDA’s reviews. B. The Polio Component This component of the project is estimated to cost about US$270million, which will be financed 100% by IDA. Under this component, the Credit will only support the purchase of polio vaccines from UNICEF (acting as supplier) to cover the requirements for 2008-09 (July onwards), 2009-10 and 2010-11. Based on the annual vaccine requirements, annual agreements between MOHFW and UNICEF will be prepared and the terms and conditions of contract shall be subject to approval by the Operations Procurement Review Committee. Additional purchases during the year, based on the number of mop-up operations required, may be necessary and also for these IDA will carry out prior reviews as appropriate. For several years UNICEF has been a reliable provider of polio vaccine to the polio endemic countries of the world, including India, and hence the procurement risk for this component is considered to be low.

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4. Social Tribal people and other vulnerable communities in India bear a disproportionate burden of vector-borne diseases and yet have low access to health care. Although they constitute only about 8% of the population, tribal people account for about 30% of all cases of malaria, more than 60% of Pf cases and 50% of malaria deaths. The third National Family Heath Survey (2005-2006) indicates that health outcomes among Scheduled Tribes (STs) are poor compared to those of the general population, and even compared to Scheduled Castes (SCs). Higher percentages of ST women are under-nourished or anemic. A major reason for the ill-health of tribal people is their poor access to health services. Underlying their excess disease burden and poor access to services are broader social and economic disadvantages: poverty, low levels of education, social exclusion, isolation from the mainstream economy, and location in areas where infrastructure and services are underdeveloped. For example, kala azar is largely a disease of the poorest people who live in mud walled houses and extremely unsanitary conditions. Tribal communities have distinct cultural behaviors and their knowledge of disease prevention and effective treatment is limited. The project contains specific measures to expand access to the diagnostic, treatment, preventive and communication activities to reduce malaria and eliminate kala azar for tribal people and other vulnerable communities. During project preparation a Social and Beneficiary Assessment (SABA) was undertaken with people living in predominantly tribal areas of four states. Tribal groups were consulted primarily through focus group discussions in sample villages and consultations were also held with local health functionaries, NGOs and community-based organizations working actively on public health-related programs. A SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis was also conducted of the on-going VBDCP in tribal areas. The SABA initiated the ‘free, prior and informed participation’ of tribal people in project design that will be carried on during project implementation. Summaries of the SABA findings and consultations are presented in Annex 11. A draft ‘Vulnerable Communities’ Plan for the Project was discussed at a consultative workshop attended by NGOs working with poor communities, including tribal people, on health and other development issues, and government health officers and staff from five key states (AP, Chhattisgarh, Jharkand, MP and Orissa). It was finalized and subsequently adopted by the Project, and is provided in Annex 11. 5. Environment This project is categorized as Category B, as it involves the use, storage, transportation, and disposal of insecticides in various applications. These insecticides require stringent and systematic management, without which there could be negative environmental and public health implications. The findings of field visits and assessments revealed that actual practices are inadequate and attention to worker safety is currently weak.

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The NVBDCP Directorate, with technical support from IDA, prepared an EMP, which prescribes critical steps needed to be put in place for strengthening insecticide management and waste management for sharps and diagnostic kits. Actions related to Pest Management have been subsumed within the EMP. The EMP is a framework, with guidelines and standardized formats for incorporation and adaptation at the state level. It recommends actions for enhancing training and supervision of workers and provision of protective equipment and their maintenance. States need to draw up training and supervision plans and inventories for storage and equipment. The Directorate will be discussing with manufacturers of insecticides issues such as supply chain management, packaging, disposal of empty containers, provision of protective gear, etc. The EMP includes a plan for augmenting institutions at state and central levels for monitoring and evaluation. It recommends strengthening of guidelines and communication materials which are target specific and pictorial. There is no construction waste envisaged, as there are no major civil works. The EMP includes a plan of action including (a) review of legal and regulatory framework for its compliance with minimum essential international standards (see Annex 11); (b) capacity building and development of guidelines; (c) discussions with manufacturers and stakeholders on best practices; (d) enhancing environmentally-sound vector management practices; (e) survey of insecticide stockpiles and storage facilities; and (f) stringent decentralized monitoring and reporting of occupational health and safety issues and EMP implementation. The reporting and monitoring systems highlighted in the EMP will be subsumed within overall program reporting. In addition, the review report of the pilot program will be submitted after the 18th month of project implementation. The EMP will be implemented in different phases. The first pilot phase is for 18 months focusing on three districts (both malaria and kala azar). The lessons learnt will be reviewed after 18 months and then replicated in the remaining project sites. It has been agreed that an environment consultant at the national level, one entomologist at the state level and malaria technical supervisors at the sub-district level will be recruited to strengthen capacity. The NVBDCP will also hire an OEHS expert to review the occupational health and safety measure being implemented under the project. India is a signatory to the Stockholm Convention which encourages the use of safe and affordable insecticides where feasible and applicable. The Government of India has constituted a Mandate committee which determines the quantity of DDT to be used and safeguards in line with the Stockholm Convention for public health use. The relevant policy documents and recommendations of this committee will be made publicly available on the website of the Ministry of Health and Family Welfare. Environmental Category: B; Safeguard Classification: S2

Safeguard Policies Triggered by the Project Yes No Environmental Assessment (OP/BP/GP 4.01) [X] [ ] Natural Habitats (OP/BP 4.04) [ ] [X ] Pest Management (OP 4.09) [ X] [ ] Cultural Property (OPN 11.03, being revised as OP 4.11) [ ] [X ] Involuntary Resettlement (OP/BP 4.12) [ ] [X]

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Indigenous Peoples (OD 4.20, being revised as OP 4.10) [X] [ ] Forests (OP/BP 4.36) [ ] [X] Safety of Dams (OP/BP 4.37) [ ] [X] Projects in Disputed Areas (OP/BP/GP 7.60) [ ] [X ] Projects on International Waterways (OP/BP/GP 7.50) [ ] [X]

OP 4.01: Environmental Assessment. The draft EMP was disclosed on the website of the NVBDCP on March 6, 2007 for a month and then re-disclosed on July 23, 2007. Stakeholder consultations were undertaken in November 2007 which included participation from relevant state authorities, manufacturers of ITN, insecticides and DDT and NGOs. The importance of implementing sound environmental and safety practices was recognized and there was general consensus on the recommendations and Action Plan provided in the EMP. O.P. 4.10 Indigenous Peoples. See Section D4 above. The draft Indigenous Peoples’ Development Plan based on field consultations was disclosed on the website of the NVBDCP on March 6, 2007. It has been replaced by the updated Vulnerable Communities’ Plan (Annex 11). O.P. 4.12 Involuntary Resettlement. This policy is not triggered as there will be no civil works or other land use in the project, and no land acquisition or use of eminent domain will be required. The polio component of this project will specifically and only finance the purchase of polio vaccine for SIAs over the first three years of the project. A similar component was prepared and appraised in July 2006, and is being financed under the India: Reproductive and Child Health Project II (RCH II) (Credit 4227IN). The Department of Family Welfare of the MOHFW is the implementing department for RCH II, and it will also implement this component, which is however implemented as a separate project with already established monitoring and supervision arrangements and substantial support from WHO and UNICEF. Social and environment safeguard actions, agreed for RCH II will apply to this component of this credit (see Annex 1B). 6. Policy exceptions and readiness No policy exceptions are implied by the project.

Safeguard clearances have been obtained. The project is ready for implementation as indicated by the following: (a) the VBDCP Project Implementation Plan has been prepared and found to be of reasonable quality; (b) the detailed procurement plan for the first 18 months has been prepared, shared with IDA and reviewed; (c) EMP and Vulnerable Communities Plan have been finalized, and disclosed to the public by the Borrower; (d) adequate allocations for the project have been included in GOI’s budget for FY2008/09; and (e) indicators for results monitoring have been agreed and will be collected routinely.

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Annex 1A: Country and Sector or Program Background (VBD)

Country and Sector Background This is a moment of significant opportunity for accelerating health gains in India. There is high level political commitment to increasing government health spending and strengthening access to services and quality in service delivery. The 11th Five-Year Plan envisages significantly increased budgets for many public health programs towards the goal of doubling government health spending as a percentage of GDP. In 2005, GOI launched the NRHM, a flagship national program to improve rural health outcomes. NRHM is an umbrella program that links together disease control and other public health programs, including NVBDCP. NRHM incorporates a number of innovative approaches in the sector, including a new national community health worker program, use of untied block grants, district-level planning, and new initiatives aimed at community mobilization and accountability. This project will benefit from but also help strengthen some of these initiatives as regards VBD control. For example, the community health worker being trained under NRHM, the ASHA will play an important role in community-level service provision for VBD in endemic areas. District planning for VBD control will be an important component of the project. Funds will be provided to strengthen the district and lower level management of VBD control interventions. GOI has also been strengthening some of the cross-cutting support systems in the sector including those related to procurement, financial management, information systems, and monitoring and evaluation. Some specific steps have been agreed as part of the joint action plan with IDA that followed a review of IDA’s DIR. These and other actions have been agreed in the project’s GAAP. A. The Vector Borne Disease Component Burden and distribution of vector-borne diseases in India Vector-borne diseases are a cluster of diseases transmitted by mosquitoes and other vectors. They include malaria, kala azar, lymphatic filariasis, Japanese encephalitis, and dengue. These diseases are still a significant source of morbidity and mortality in India. The following matrix summarizes the transmission mechanisms of each disease, its health effects in terms of morbidity and mortality, and geographical dispersion.

Type of Vector Borne

Disease

Description of the Vector and

Causative Agent

Description of the Infection and health impact

Geographical dispersion

Malaria Vector: Anopheles mosquitoes, which breed in clean water

One to two weeks or more after a person becomes infected, first symptoms appear. Typically, malaria

Of all reported malaria cases in India during 2005,

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and feed during the night Causative Agent: Plasmodium parasites. Among different species of the parasite, falciparum causes most severe form of malaria with higher mortality risk. The other commonly reported species in India is vivax.

produces fever, headache, vomiting and other flu-like symptoms. The parasite infects and destroys red blood cells resulting in anemia. Infections with falciparum may cause cerebral malaria with fits/convulsions and loss of consciousness, and often death. Malaria in pregnancy poses a substantial risk to the mother, the fetus and the newborn infant.

about 90% were in 11 States: Orissa, 22%; Jharkhand, 11%; Chhattisgarh, 10%; West Bengal, 10%; Gujarat, 10%; Madhya Pradesh, 6%; Uttar Pradesh, 6%; Karnataka, 5%; Assam, 4%; Rajasthan, 3% and Maharashtra, 3%.

Kala azar/ Visceral Leishmaniasis

Vector: Female phlebotomine (sandfly). The sandflies breed in the presence of organic debris, making homes with mud walls plastered with cow dung ideal for breeding. These sandflies feed on blood (usually in the evening and at night) and can travel about a radius of a few hundred meters around its habitat. Causative Agent: Leishmania donovani, a parasite mainly residing in bone marrow, spleen and liver. No intermediate host is known in India (i.e. humans are the only hosts). P. argentipes is the only vector responsible for kala azar in India

Kala azar is a slow progressing disease and often recognized late. Kala azar infection is manifested in two forms. Initial infection leads to acute disease, i.e. Kala azar. Later on, skin manifestations of kala azar infection, known as Post Kala- azar Dermal Leishmaniasis (PKDL), may appear after variable periods ranging up to a few years. Kala azar is characterized by irregular bouts of fever, darkening of the skin substantial weight loss, swelling of the spleen and liver, and anemia. If left untreated, the case fatality rate can be as high as 100% within two years. Patients with PKDL are not in danger of dying from the disease, but are contagious.

Practically all cases of Kala azar reported in 2005 are from three States: Bihar, 70%; Jharkhand, 21%; and West Bengal, 9%.

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The National Vector Borne Disease Control Program (NVBDCP) The NVBDCP is an umbrella program for the prevention and control of vector borne diseases in India, jointly implemented by the central government and the States. The Directorate of NVBDCP, under the Directorate General of Health Services, MOHFW, Government of India, is the national level government unit dedicated to the program. As such, it is responsible for formulating policies and guidelines, monitoring, and carrying out evaluations from time to time. The Directorate of NVBDCP is also responsible for administering GOI’s financial assistance to the States in the context of the program. The program is funded in equal shares by GOI and the states. The MOHFW’s 17 Regional Offices for Health and Family Welfare, located in 17 States, also play a role in the NVBDCP. They conduct entomological studies in collaboration with the States, drug resistance studies, cross-checking of blood slides for quality control, capacity building at the state level, and monitoring and supervision. The states are responsible for implementing the program’s preventive and curative services, and monitoring in accordance with central guidelines. Every state has a Vector Borne Disease Control Unit under its Department of Health and Family Welfare. The state unit is headed by the State Program Officer, who is responsible for day-to-day management as well as technical aspects of the program. The states have established State Vector Borne Disease Control Societies, which are now merged with similar entities established for other centrally sponsored schemes into a single state-level Health and Family Welfare Society. The main role of the Societies is to channel funds from GOI to the states (and onwards to districts) for the financing of the programs (VBDCP and other centrally sponsored schemes). They also play a role in district planning and in monitoring of program activities within districts. At the district level, district malaria offices have been established in most places headed by the District Malaria Program Officer. This is the key unit for the planning and monitoring of the program. In many districts, District Vector Borne Disease Control Societies have been established to assist with the management of funds and with planning and monitoring of program activities. Actual program services are carried out by staff in the states’ Departments of Health and Family Welfare facilities, and in some cases by outreach workers, such as the active surveillance carried out by peripheral health workers and community volunteers.

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Main Program Issues12 A. The need to update the Policy for Malaria Diagnosis and Treatment The current policy for malaria diagnosis and treatment in the public sector varies according to whether a given area is classified as a low malaria risk area or a high-risk area, and within high-risk areas depending on whether a high level of chloroquine resistance in P. falciparum cases has been ascertained or not. Specifically, catchment areas of primary health centers are classified as high malaria risk areas if any of the following applies (otherwise they are classified as low risk areas): � Deaths due to malaria have been reported (on clinical diagnosis or microscopic

confirmation). � The Slide Positivity Rate (SPR) has doubled during the last three years, provided the SPR in

the second or third year reaches 4% or higher; or the average SPR of the last three years is 5% or higher.

� P. falciparum proportion is 30% or higher of all reported malaria cases, provided the SPR is 3% or higher during any of the last three years.

� Any area having a focus of Chloroquine-resistant P. falciparum. � Agglomeration of migrant labor in endemic/receptive and vulnerable areas. High-risk areas are further divided, for the purposes of malaria diagnosis and treatment, between those areas where a high (greater than 10%) level of resistance to chloroquine in P. falciparum cases has been ascertained and those areas where such high level of resistance has not been ascertained. There are currently different guidelines for malaria treatment in the public sector for: (a) low-risk areas; (b) high-risk areas where chloroquine resistance levels greater than 10% have been ascertained; and (c) high-risk areas where levels of chloroquine resistance greater than 10% have not been ascertained. There are several important problems with the current policies for the diagnosis and treatment of malaria cases. These problems were highlighted in the report of the recent joint monitoring mission (JMM), an external review of the program conducted with technical assistance from WHO, which also provides clear recommendations on how these problems should be addressed. As indicated in the JMM report, the challenge will be to the confirmation of malaria diagnosis. The economic analysis suggests that the proposed case management policies will be efficacious. However, they will be expensive to start with, but the costs will rapidly come down making this approach cost effective13.

12 This section is based on the report of the February 2007 Joint Monitoring Mission organized by WHO: National Vector-Borne Disease Control Program: Joint Monitoring Mission Preliminary Report, February 2007. 13 A.Schapira (2007) At what level of risk of P.falciparum are rapid diagnostic tests no longer a cost-effective option (unpublished)

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The treatment guidelines to be implemented in the present project will be based on the following principles:

(a) The ACT will be used as the first line treatment for all confirmed Pf malaria cases except for pregnant women for whom the program will have specific treatment guidelines. This policy will be introduced in a phased manner to cover nation-wide according to a prioritized plan including diagnostics, training, quality assurance, supply chain management and information to the public;

(b) (b) The surveillance of malaria will have more emphasis on passive case detection

(PCD). The target will be blood slide or RDK for all suspected malaria cases, not a fixed 10% annual blood examination rate. Active case detection (ACD) will be restricted to pockets of problem areas particularly areas with poor access to PCD;

(c) All suspected malaria cases will be tested 14 before treatment; and

(d) As per the current policy, presumptive treatment for malaria will be discontinued in all

settings, where a confirmatory diagnosis with microscopy or RDK is available within 24 hours.

The main challenge in terms of training, logistics and funding for implementing the new treatment policy is confirming malaria diagnosis by blood slide or RDK. In most cases, this will have to be done by an HRP2-based RDK. Use of RDKs should be prioritized in health facilities where blood slide results cannot be obtained within 24 hours. Based on experiences in the north-east, the national program must now estimate the commodities, training, supervision and quality assurance needs for each state for introducing ACT. Once rough state-wise needs estimation has been done by a desk study, states and in some cases, districts should be prioritized, with the Pf incidence as the main criterion and the level of resistance as a supplementary criterion. The prioritized states should receive full national level support to roll-out the new treatment regimen in the government facilities within one year and in the private sector within two years. An implementation plan including clear objectives, targets, timelines, and appropriate process and output indicators for monitoring should be developed for rolling out the new treatment policy nation-wide. Funding should be mobilized (as part of the overall program funding) to complete the roll-out of the new case management strategy nationwide through public and private sectors within 4 years. A general algorithm for application of the new policy can be summarized in the following flow-charts, which are based on the above principles. These guidelines are, of course, subject to revision on the basis of new evidence from India and/or WHO.

14 Precise guidelines on criteria for suspicion of malaria should be prepared by NVBDCP at central level according to the following principles: Malaria should be suspected in patients who present with fever or anemia living in a malaria- risk areas (e.g. PHC) or having visited an endemic area within the last month. A malaria-endemic area could for example be defined as having had an SPR above 1% at some period during the latest 3 years. In non-endemic areas, tests for malaria should also be carried out on members of the family of a confirmed malaria case, if they have fever or anemia and on patients belonging to any unusual cluster of fever cases.

30

ACT= artemisinin-based combination therapy; CQ= chloroquine; PQ=primaquine *Patient at high risk of PF (when living in area, where last year’s SFR<2%). Criteria need to be worked out. They could be for example: visited PF endemic area within last 6 months, or belongs to aggregated labor force or household with recent PF case. ** Pregnant Women: Quinine per os for 7 days. The possible addition of clindamycin for higher effectiveness needs to be considered (viz. WHO treatment guidelines)

Where microscopy result is available within 24 hours

Fever patient in malarious area or having visited malaria risk area within last 6 months

Take slide

If negative: No antimalarial treatment

If PF: ACT (3 d)** If PV: CQ 25 mg/kg over 3d + PQ 0.25 mg/kg/day over 14 d

Where microscopy result is not available within 24 hours

Fever patient in malarious area or having visited malarious area within last 6 months

Take RDK for PF and slide

If slide shows PF: ACT**

PHC block, where last year’s SFR>=2%, or if patient at high risk of PF*

If RDK pos.: ACT**

If RDK neg.: CQ 25 mg/kg over 3d

If slide shows PV: PQ 0.25 mg/kg/day over 14 d

PHC block, where last year’s SFR<2%, if patient not at high risk of PF*

Take slide and give CQ 25 mg/kg over 3d

31

Comments:

(a) These flowcharts limit the use of RDKs to the settings, where they are most needed. The treatment providers may not comply with such guidelines, as RDKs tend to become very popular and there is a risk that in areas with low risk of PF, they could be used indiscriminately. This remains to be seen, but the risks will probably be limited by the fact that it is not very interesting to observe negative test results continuously.

(b) It is somewhat unsatisfactory that the numbers of slides to be taken in PCD and the

quantities of chloroquine dispensed will not be much reduced. This is justified by the need for having continuity in surveillance, and because PV is still common in many areas of low PF risk. When more experience has been gained, and when RDKs for PV have been validated, this may change.

32

Annex 1B: Country and Sector or Program Background (Polio)

Background Through the Polio Component the project will support the World Health Organization (WHO)-launched Global Polio Eradication Initiative which is the largest public health initiative ever and which has successfully eliminated polio from all but four countries15. The defined international goals of polio eradication are: (a) no cases of clinical poliomyelitis associated with wild poliovirus; and (b) no wild poliovirus found worldwide despite intensive efforts to do so. A country or region is certified as polio free when the Regional or Global Certification Committee of independent experts has certified that the country/region has had no case of polio from wild polio virus for three years and that good surveillance has been carried out. Polio virus transmission in endemic countries remains the last hurdle for a polio free world as a single infected child can put the entire world’s children at risk. India joined the global polio eradication efforts in 1995 by starting the National Immunization Days (NIDs). Polio eradication efforts progressed well until they suffered a set-back in 2002 with a major increase of polio cases in the state of Uttar Pradesh. This placed a substantial operational challenge as well as financial burden on the country due to steeply enhanced operational and vaccine costs. While the major burden has been shouldered by the GOI and the state governments, IDA, along with other development partners responded to this urgent need for additional financing through re-allocation of credit proceeds (US$96 million) from five health projects as well as providing US$40 million through the second Reproductive and Child Health Project (RCH II). India’s Polio Eradication Strategy India’s polio eradication strategy focuses on: (a) Reaching and maintaining the highest possible routine immunization coverage with at least three doses of OPV; (b) Supplementary Immunization Activities (NIDs and SNIDs) to deliver supplemental doses to all children under-five; (c) Mop-up and outbreak response activities around any new case; (d) an acute flaccid paralysis (AFP) surveillance system to detect and investigate every case in children under 15 years of age and all suspected cases of polio regardless of age; and (e) Community mobilization and awareness campaigns. Reaching High Immunization Coverage through Routine Immunization: With the introduction of the National Rural Health Mission in 2005 the GOI placed clear emphasis on improving the delivery of basic services – including immunization services – to all its people especially those who are generally under served and vulnerable. Training and capacity building of staff, the introduction of a Routine Immunization Monitoring System, increasing the honorarium for vaccinators and supervisors engaged in pulse polio as well as the recent re-engineering of immunization initiative are likely to substantially improve overall immunization coverage including coverage with polio vaccine. 15 India, Pakistan, Afghanistan and Nigeria

33

NIDs and SNIDs: Operationalizing SIAs is a challenging task with immunization of more than 170 million children in each round of NIDs and between 70-80 million children in SNIDs. SIAs are being effectively implemented with on average more than 90% of the target group immunized during the 2007 and 2008 rounds. A fully functional AFP surveillance system provides regular quality data to help identify districts with virus circulation and is used as a guide to modify program strategies as needed. Information from the AFP system has identified two states (UP and Bihar) as high risk due to wild polio virus transmission in 2007 and 2008. Technical advice on SIAs is provided by IEAG, consisting of international and national experts. The IEAG concurred with the GOI and technical partners during its May 2008 meeting that there is a good chance of having the last Type 1 case this year and a possibility of seeing the last case of Type 3 polio in 2009. Mop-up and Outbreak Response: While the key strategy remains as NIDs supplemented with SNIDs in Uttar Pradesh and Bihar the main strategy to wipe out Type 1 virus in all states and to control Type 3 virus in all other states is to respond rapidly with aggressive, large scale mop-ups to interrupt any remaining chains of wild polio virus transmission. For each case diagnosed, decisions for ‘mop up’ immunization activities and use of specific monovalent polio vaccine are immediately undertaken by the Operation Group on Polio (OPS16) following which all possible human resources are mobilized in a meticulously planned and executed outbreak response. The need for an immediate response to each case and a case by case decision on mop-up response require some flexibility in financing for polio vaccine since the requirements cannot be fully predicted ahead of time. Therefore a major reason for GOI to seek IDA financing is the provision of the necessary financial security. AFP Surveillance System: The AFP surveillance is linked to a highly reliable and efficient network of laboratories that provides real time information on poliovirus. Each laboratory uses standardized methodologies and reagents and annually undergoes proficiency testing and a rigorous process of WHO accreditation. The laboratories are monitored for timeliness of result reporting. These laboratories perform virus isolation, sero typing, intra-type differentiation (Sabin vs wild poliovirus) and genetic sequencing of poliovirus isolates. As members of the network, a variety of government and academic research laboratories are functioning in a new paradigm of national public health laboratories. Every case of AFP in children under 15 years of age and all suspected cases of polio regardless of age is currently investigated for polio virus. 18,500 informers comprised of medical practitioners, traditional healers and priests in temples/shrines report AFP cases with more than 41,518 AFP cases having been reported and investigated in 2007. Stool specimens collected from AFP cases are tested in one of the 8 WHO-accredited poliovirus laboratories in the network. While response time earlier was 57 days it has now been reduced to 25 days – which is as good as any laboratory in the world. In 2007, 80,648 specimens were collected, shipped and processed by the laboratory network. Community Awareness Campaigns: While the Government mobilizes all possible human resources for NIDs and SNIDs, UNICEF adds an extensive network of 3,300 Community Mobilizing Coordinators, whose sole role it is to get the word out among communities that the

16 includes Rotary International, Indian Council of Medical Research, Public Health Foundation of India besides MOHFW, WHO-NPSP and UNICEF.

34

polio immunization activities are being conducted and reminding parents on the importance to have their children immunized. The engagement of local influencers and religious leaders helps reduce any potential resistance to the polio vaccine among communities. 'Special teams' of local influencers or local community or religious leaders including Rotary International volunteers visit homes of parents who may have concerns about the safety of the polio vaccine. Vaccinators carry written statements to re-assure parents that polio vaccination is the right thing to do for their children. Implementation Arrangements The MOHFW has the overall responsibility for program implementation at the national level. At the State level, the Secretary/Principle Secretary of Health heads the program while program implementation is managed under the guidance of the Director General Health Services. At the District levels, the District Magistrate/Collector monitors the program on a regular basis while implementation is the responsibility of the Chief Medical Officer of the district. The District team undertakes detailed micro-planning for each round of NIDs or SNIDs ensuring all systems are functional. In addition, the district team calculates and verifies the target population, number and location of NID posts and cold chain needs. The mass media, religious and community leaders play a key role in raising awareness and mobilizing the public. School teachers, community members and Anganwadi Workers are all involved in administering the oral vaccine. The recent introduction of the Health Volunteer or ASHA under the National Rural Health Mission has provided an excellent additional resource at the village level. While the existing government structures uses all possible avenues and human resources available to implement the program; support for technical assistance and management support for monitoring, surveillance, training and the laboratory network is provided by WHO through the NPSP and support for social mobilization provided by UNICEF. Vaccine will be purchased through UNICEF with substantial additional support from Rotary India’s local club members. The IEAG, regularly provides advice on programmatic issues based on the epidemiology of the disease and the latest laboratory findings of polio virus from active cases. Monitoring Polio Eradication Efforts in India The following arrangements are in place to constantly monitor the states of polio eradication:

• An independent monitoring system is in place to identify the gaps in preparedness and implementation of the SIAs

• Independent monitors include the following o Consultants from WHO and CDC o NPSP surveillance medical officers (SMOs) and technical staff from NPSP Delhi o Field volunteers and other monitors hired locally by SMOs

• The total number of monitors deployed during each NID is nearly 3500. Of these, 35% are deployed in UP and 22% in Bihar. The monitors are deployed for the entire duration

35

of the campaign i.e. 6 to 7 days in UP and Bihar and 3 days in rest of India. In UP and Bihar nearly 420,000 houses and 11,000 vaccination teams are monitored during each round by these monitors

Monitoring during the Preparatory Phase: During the preparatory phase, monitors assess the quality of micro plans, training and involvement of the district and sub-district government officials in the program. If any serious problems are noted by the monitors, prompt feedback is provided to senior officers at the state levels to address them. At the district level, the monitoring information is shared during the district task force meetings chaired by the district magistrate and attended by the Chief Medical officer of the district. Feedback from monitoring is also provided to the divisional commissioners and to the state secretaries. In addition, a Polio Operations Group monitors the vaccine supply and logistics regularly while the Social Mobilization Group provides oversight for BCC activities.

Monitoring during the campaigns includes the following:

• The monitoring gives more emphasis to the areas where coverage levels are generally poor and which therefore are at a higher risk of polio transmission

• Monitors assess the operational processes that influence the quality of the immunization activity such as composition, work load and training status of vaccination teams, quality of vaccine being used, involvement of local influencers and leaders in the campaign, vaccination at transit sites and other high risk and hard to reach areas like brick kilns, construction sites, riverine areas.

• Special emphasis is given to monitoring the vaccination and tracking of new born children

• Areas with under served population are intensively monitored to asses whether services are reaching these highest risk population groups

• Monitors randomly visit houses to validate the coverage reports provided by the vaccination teams to look for any unimmunized children are left in houses reported to have been fully covered.

• Monitors also visit houses where the vaccination teams have not been able to immunize all children for various reasons such as sickness of child, refusal by parents, child away from home or house locked.

• Monitors make an overall assessment of the houses with potentially missed children in each area

• An important activity performed by monitors during the campaign is to assist the collation, analysis and review of administrative data on each day of the activity. This analyzed information on children immunized, houses visited during the day along with the monitoring feedback drive the discussions every evening when the district magistrates, chief medical officers and other staff review the program

Feedback from monitors includes: • Immediate feedback on the vaccination teams and supervisors who are found to be

performing poorly in the field

36

• Feedback provided to the district and sub-district health and administrative staff either each evening during the NID or SND days or at the end of each round for corrections during the subsequent days of the current round and during future rounds

Impact of monitoring is categorized into two broad groups: • Improved coverage during SNIDS/NIDS measured by a reduction in the number of

houses missed over rounds. Example: The percentage of houses with potentially missed children in Moradabad district of Western UP (the epicenter of the 2006 outbreak) reduced from 14% in late 2005 to 7% during 2007.

• Concurrent monitoring has helped the program implementers to make tactical changes in the strategy to reach the children at highest risk. Newer initiatives such as new born tracking, covering migratory populations, ensuring revisit of vaccination teams to houses where children have been missed are a result of the monitoring findings.

Vaccine Quality. While the systems for vaccine delivery, storage and distribution are already in place, the regular replacement of cold-chain infrastructure is provided for under the RCH II project. Vaccine purchased through UNICEF is WHO pre-qualified/ WHO approved the each batch is also tested by the National Laboratory Kasauli. In addition Vaccine Vial Monitors (VVMs) on separate vials alerts the end user to any problems in the cold chain thereby assuring vaccine efficacy. Present status of Polio Eradication Most parts of India are today polio free. Of the 35 states and Union Territories, indigenous polio transmission has been stopped in 33 States / UTs. Only UP and Bihar remain endemic because of uniquely challenging conditions. The two states together comprise 25% of India’s population and 35- 40% of India’s poor households. In addition, the two states face challenging conditions such as poor environmental sanitation, high population density, high illiteracy, low coverage of routine immunization and high birth rate which makes it challenging to eradicate polio. Recognizing the persistence of Type 1 polio virus in both states the IEAG in 2005 recommended that the program should focus on the use of monovalent type 1 vaccine during SIAs in these two states. Since then most vaccination campaigns in UP and Bihar have used monovalent Type 1 vaccine. The impact has been s sharp reduction in type 1 polio cases with only five cases this year till June 2008 as compared to 83 cases in 2007. This strategy has however led to a resurgence of type 3 polio cases in both states with 270 registered cases for the year till June 2008, compared to 793 in 2007).

37

Polio Cases in India 1998-2008

Red/Dark: Type 1 cases Blue/Light: Type 3 cases

The May 2008 meeting of the IEAG reaffirmed that the activities in the second half of 2008 should focus on the final interruption of type 1 wild polio virus transmission, while maintaining good control of polio virus type 3. Following the interruption of polio virus type 1 transmission, focus should be shifted to interrupting polio virus type 3 transmission. While appreciating the enormous efforts made by the GOI and the recent achievements in substantially reducing the number of cases, the May 2008 IEAG meeting further identified the need for multi-year secured vaccine financing. During NIDs India reaches more than 170 million children and during SNIDs the target group for UP is 37 million children and for Bihar it is 20 million. With the needs for polio vaccine in the world rapidly reducing, the number of suppliers is decreasing, making it difficult for GOI to ensure adequate vaccine supplies. The IEAG noted this problem as an important risk to polio eradiation in India and the world and recommended that secure financing will allow multi-year polio vaccine tendering, thereby securing timely supplies. As the polio epidemiology is rapidly changing, the vaccine needs for the program will also change. Therefore, the program now requires more flexibility in using different types of oral polio vaccines (monovalent type 1 and 3 or tri valent) depending on the local epidemiology.

0

250

500

750

1000

1250

1500

1750

2000

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008*

38

Cost of Polio Eradication in India Estimated Resource Requirements for Polio Eradication 2008-2011 (in US$ million): Budget line 2008 2009 201017 2011 Total Vaccine 138 117 58 60 373 Operations (GOI) 160 125 65 65 415 Operations (WHO) 7 6 6 6 25 Social Mobilization (UNICEF)

13 7 5 5 30

Surveillance Network including laboratories (WHO)

21 22 23 23 89

Total 339 277 157 159 932 While there may also be additional financing available from other external sources, the financing gap is currently expected to be to the order of US$230 – 270 million. However, as explained earlier in Annex 1B, the total vaccine requirements cannot be precisely predicted, due to the nature of the epidemiology of the virus.

17 This is based on the ‘best case scenario’ that the last case of type 1 polio occurs in 2008 and the last case of type 3 polio occurs in 2009

39

Annex 2: Major Related Projects Financed by IDA/Bank

Sector: Health,

Nutrition and

Population

Project Cr. No. ISR/PSR –IEG/OED Ratings As of May 1, 2008

Development Objective

Implementation Progress (IP)

OED Rating

IDA-financed Ongoing

Uttar Pradesh/Uttarakhand Health Systems

3338

S S

Food and Drugs Capacity Building

3777 U

HU

Rajasthan Health Systems

3867 MS MS

Integrated Disease Surveillance

3952 MS MS

Tamil Nadu Health 4018 S S Reproductive and

Child Health Project II

4227 MS MS

Second National Tuberculosis Control

4228 S S

Karnataka Health System Development and Reform

4229 MS MU

Third National HIV/AIDS Control Project

4299 S HS

IDA-financed Closed

Immunization Strengthening

3340 MS MS MS

Second National Leprosy Elimination

3482 S S S

2nd HIV/AIDS 3242 S S MS Maharashtra Health

Systems 3149 MS MS MS

Orissa Health Systems

N017 MS MS MS

Tuberculosis Control

2396 S S S

Malaria Control 2964 S S MS

40

Woman and Child Development

N042 MS MS S

State Health Systems II

2833 S S S

Population VIII 2394 HS S S Population IX 2630 S S MS National AIDS

Control 2350 S HS S

AP First Referral 2663 HS S HS Cataract Blindness 2611 S S HS ICDS II 2470 S S U Reproductive and

Child Health I N0181 S S U

APERP (Andhra Pradesh Economic Restructuring Program)

3103 S S S

41

Annex 3A: Results Framework and Monitoring Matrix

PDO Outcome Indicators Use of Outcome

Information (a) To enhance the effectiveness of government response to control malaria and eliminate kala azar and eradicate polio. This will be achieved by increase in the number of people benefiting from effective prevention, diagnosis and treatment services for malaria control and kala azar and vaccination for polio.

� For malaria: (i) Percentage of fever cases in project districts receiving a malaria test result no later than the day after the first contact.18 (ii) Percentage of individuals in project areas belonging to eligible LLIN target population who slept under an LLIN during the previous night. � For kala azar: (iii) At least 50% of sampled blocks which at baseline have not achieved the elimination goal of less than one kala azar case per 10,000 persons, will achieve the elimination goal by endline.19 � For polio: (iv) At least 80% of the households with eligible children covered during national and sub- national immunization days in high risk districts20.

• Review current strategies

and make tactical changes to the program plan to improve effectiveness

• Develop clear lessons

about effective strategies that can be brought to scale and support the design of the next phase of the program

18 Indicator a.i is likely to be highly correlated with PDO (a), because in rural areas with a limited range of service providers, individuals who have access to an RDT should also have access to ACT. Population survey data will also indicate where care was sought. The ideal indicator to assess ACT use will be the % of Pf positive cases in the population who were given ACT no later than the day after the fever started. But it is not possible to measure directly because: (a) not all fever cases will seek and receive a test result from designated providers, and (b) not all fever cases who receive a test result will be Pf positive as most do not have malaria or have only Pv. The ACT treatment indicator for Pf+ cases can be estimated indirectly, from health service data. The PAD is not proposing this as a PDO indicator as it cannot be estimated from surveys with adequate precision. It will however be estimated routinely from service data, on the proportion of fever cases, which received a test result/were treated with ACT if Pf confirmed, no later than the day following the first contact. 19 The protocol of the evaluation sample survey will be agreed between RMRI, NVBDCP, the States and the Bank in consultation with the WHO by August 2008. 20 High risk districts (currently only in UP and Bihar) are those where wild polio cases are still endemic i.e. where there is indigenous polio transmission.

42

Intermediate Results Results Indicators for Each

Component Use of Result Monitoring

Component One: Improving Access to and Use of Malaria Prevention and Control Services 1.a. Control of Malaria

a. i. Percentage of population in high-risk project areas protected by LLINs or IRS. a. ii. Percentage of RDT positive cases in project districts receiving ACT no later than the day after the first contact21.

a. iii Percentage of designated providers of malaria diagnosis and treatment22 who have not had an ACT or RDT stock out during the last 3 months a. iv Percentage of villages with a trained designated provider of malaria diagnosis and treatment services.

District-level: to make tactical changes to the program plan to improve effectiveness and correct problems.

State and central level: to adjust training and supervision activities; to identify problems requiring comprehensive change to the program plan. Establish results based management system to guide financial investments.

Component Two: Improving Access to and Use of Services for Elimination of Kala azar 2a. Elimination of kala azar

a.i. Percentage of diagnosed kala azar cases completing the standard treatment as per the national guidelines. a.ii. Percentage of houses in targeted kala azar endemic areas covered with effective insecticide spray.

a.iii Percentage of Block PHCs that do not have a ‘Rapid Diagnostic Test for Kala azar’ or, first line medicines stockout during the last 3 months.

District-level: to make tactical changes to the program plan to improve effectiveness and correct problems. State and central level: to adjust training and supervision activities; to identify problems requiring comprehensive change to the program plan.

Establish results based management system to guide financial investments.

21 “Adults” here would mean individuals 15 years or older. Cases in this age group having a positive test for Pf will be expected to receive an ACT blister pack, which will be easy to measure in surveys. Younger age-groups are expected to receive loose artesunate and sulfadoxine-pyrimethamine tablets, which will be difficult to identify in surveys. Current blood examination rates suggest that a majority of blood tests are currently conducted in the 15+ years age group. Also see footnote #1. 22 These individuals are ASHAs and other providers and Multi-Purpose Health Workers.

43

Component Three: Policy and Strategy Development, Capacity Building and Monitoring and Evaluation 3.a. Policy and strategy development

3.b. Capacity building and program management 3.c. Monitoring and evaluation

a. i. Monitoring system established in 5+ sites to monitor the quality of RDTs, drugs and insecticides delivered by the procurement system a.ii Monitoring of therapeutic efficacy of ACTs with at least 15 studies per year and pharmaco-vigilance system including at least 3 sites monitoring the first line medicines introduced under the kala azar elimination program established . b. i. Percentage of planned additional staff who are in position at central, state and district levels and received induction training. b.ii Proportion of districts meeting the readiness criteria (Annex 6) for each period of implementation.

c.i. Percentage of endemic districts with quality controlled incidence data of vector-borne diseases stratified by age and gender

Ensure drugs and insecticides used in the project conform to national policy and are of the highest quality. Monitor implementation of the management strengthening plan.

Establish priorities for program planning

Component Four: Polio Eradication 4. Polio Eradication

No stock outs of OPV for SIAs

This framework will include assessment of equity as determined by the access of scheduled tribes and scheduled castes (SC/ST) to the quality services, which will be established. Thus, most of the indicators described above, and derived either from HMIS or from large surveys, will be disaggregated by general population/SC/ST as described in the Vulnerable Communities’ Plan (Annex 11).

44

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stab

lish

the

base

line.

45

Inte

rmed

iate

Res

ult:

Com

pone

nt O

ne:

Im

prov

ing

Acc

ess

to a

nd U

se o

f M

alar

ia P

reve

ntio

n an

d co

ntro

l Ser

vice

s E

25

%

40%

60

%

80%

>8

0%

1. a

. i. P

erce

ntag

e of

pop

ulat

ion

in

high

-ris

k pr

ojec

t are

as p

rote

cted

by

ITN

s or

IR

S

L

No

Rel

iabl

e D

ata

NA

N

A

25%

40

%

70%

A

nnua

l

HM

IS a

nd

LQ

AS/

Popu

la-

tion

surv

eys

E

50%

60

%

70%

80

%

>80%

1.

a. i

i Per

cent

age

of R

DT

pos

itive

ca

ses

amon

g ad

ults

rec

eivi

ng A

CT

no

late

r th

an th

e da

y af

ter

the

feve

r st

arte

d L

NA

(N

ew

Prog

ram

)26

NA

N

A

50%

60

%

70%

Ann

ual

H

MIS

E

80%

80

%

90%

90

%

90%

1.

a. i

ii Pe

rcen

t of

desi

gnat

ed

prov

ider

s of

mal

aria

dia

gnos

is a

nd

trea

tmen

t who

hav

e no

t had

an

AC

T o

r R

DT

sto

ck o

ut d

urin

g th

e la

st 3

m

onth

s L

NA

(n

ew

prog

ram

) N

A

NA

80

%

90%

90

%

Ann

ual

H

ealth

fac

ility

su

rvey

-LQ

AS

E

60%

70

%

80%

>8

0%

>80%

1.

a. i

v Pe

rcen

tage

of

villa

ges

with

a

trai

ned

desi

gnat

ed p

rovi

der

of m

alar

ia

diag

nose

s an

d tr

eatm

ent s

ervi

ces.

L

20

%

NA

N

A

20%

30

%

70%

A

nnua

l

LQ

AS

M

TS

(LQ

AS)

/ N

atio

nal I

nstit

ute

of M

alar

ia

Res

earc

h (l

arge

-sc

ale

surv

eys)

Com

pone

nt T

wo:

Im

prov

ing

Acc

ess

to a

nd U

se o

f Se

rvic

es f

or E

limin

atio

n of

Kal

a az

ar

2. a

.i. P

erce

ntag

e of

dia

gnos

ed k

ala

azar

cas

es c

ompl

etin

g th

e st

anda

rd

trea

tmen

t.

TB

D

60

%

80

%

>80%

Bi-

annu

al

Popu

latio

n-ba

sed

Stud

y

K

TS

/ Nat

iona

l In

stitu

te o

f M

alar

ia R

esea

rch

2. a

.ii. P

erce

ntag

e of

hou

ses

in

iden

tifie

d in

kal

a az

ar e

ndem

ic a

reas

co

vere

d w

ith e

ffec

tive

inse

ctic

ide

spra

y.

TB

D

60

%

80

%

>80%

Bi-

annu

al

Popu

latio

n-ba

sed

Stud

y

K

TS

/ Nat

iona

l In

stitu

te o

f M

alar

ia R

esea

rch

2 a.

iii P

erce

ntag

e of

fac

ilitie

s re

port

ing

no s

tock

-out

s of

‘R

apid

Dia

gnos

tic

Tes

t for

Kal

a az

ar’

and

firs

t lin

e m

edic

ines

.

NA

50

%

80%

90

%

90%

90

%

Ann

ual

Hea

lth f

acili

ty

surv

ey-L

QA

S

26

See

foo

tnot

e 14

und

er p

revi

ous

tabl

e.

46

Com

pone

nt T

hree

: P

olic

y an

d St

rate

gy D

evel

opm

ent,

Cap

acity

Bui

ldin

g an

d M

onito

ring

and

Eva

luat

ion

3. a

. i. M

onito

ring

sys

tem

es

tabl

ishe

d in

5+

site

s to

mon

itor

the

qual

ity o

f R

DT

s, d

rugs

and

in

sect

icid

es d

eliv

ered

by

the

proc

urem

ent s

yste

m

0 (n

ew

prog

ram

) 2

4 5

5 5

Ann

ual

HM

IS

Nat

iona

l Ins

titut

e of

Mal

aria

R

esea

rch

3. a

.ii P

harm

aco-

vigi

lanc

e sy

stem

est

ablis

hed

in a

t lea

st 3

si

tes

to m

onito

r th

e fi

rst l

ine

med

icin

es f

or k

ala

azar

el

imin

atio

n

0 2

3 3

3 3

Ann

ual

HM

IS

RM

RI

3. b

.i Pe

rcen

tage

of

plan

ned

addi

tiona

l sta

ff w

ho a

re in

po

sitio

n at

cen

tral

, sta

te a

nd

dist

rict

leve

ls a

nd r

ecei

ved

indu

ctio

n tr

aini

ng.

0%

(new

pr

ogra

m)

50%

10

0%

100%

10

0%

100%

A

nnua

l H

MIS

N

atio

nal I

nstit

ute

of M

alar

ia

Res

earc

h

3. b

.ii P

ropo

rtio

n of

elig

ible

di

stri

cts

mee

ting

the

read

ines

s cr

iteri

a (A

nnex

6)

for

each

per

iod

of im

plem

enta

tion.

0 10

0%

100%

10

0%

100%

10

0%

Ann

ual

Rea

dine

ss f

ilter

s D

irec

tora

te

NV

BD

CP

3. c

.i. P

erce

ntag

e of

end

emic

di

stri

cts

with

qua

lity

cont

rolle

d in

cide

nce

data

of

vect

or-b

orne

di

seas

es s

trat

ifie

d by

age

and

ge

nder

0%

(new

pr

ogra

m)

20%

30

%

40%

50

%

60%

A

nnua

l H

MIS

N

atio

nal I

nstit

ute

of M

alar

ia

Res

earc

h

Com

pone

nt F

our:

Pol

io E

radi

catio

n

4. N

o st

ock

out o

f or

al p

olio

va

ccin

es f

or S

IAs

N

o st

ock

out

No

stoc

k ou

t

No

stoc

k ou

t

No

stoc

k ou

t

Qua

rter

ly

Prog

ram

Rep

orts

M

OH

FW

47

MONITORING AND EVALUATION ACTIVITIES

A. The Vector Borne Disease Component A robust project management and monitoring system will be implemented to monitor progress towards targets and objectives and provide continuous feedback to strengthen and improve delivery mechanisms at the district level. To achieve this, the project’s M&E activities include:

For malaria control

(a) Strengthening of HMIS for tracking malaria incidence and operational indicators; (b) Sentinel surveillance to collect data on severe malaria, hospitalized malaria and

malaria deaths from selected hospitals in each district; (c) Decentralized measurement of outcomes at district and PHC levels through Lot

Quality Assurance Sampling (LQAS) and cross-sectional surveys (latter every second year) to support local decision-making and provide objective monitoring to the central level;

(d) Logistic Management Information System for supply chain management; (e) System to monitor the quality of rapid diagnostic tests and medicines to ensure their

quality upon delivery and at point of use. For kala azar elimination

(a) Strengthening of HMIS for tracking the progress of kala azar elimination and key operational indicators;

(b) Case detection and line listing of patients (c) Decentralized assessment to validate the outcomes at district, CHC and PHC levels

through LQAS and surveys (2010 and 2013) (d) Logistic management information system for supply chain management (e) System to monitor the quality of ‘Rapid Diagnostic Test for Kala azar’, and first line

medicines Additional activities closely related to M&E, though not strictly part of the M&E system are:

• Monitoring of parasite resistance to antimalarial medicines, in particular the first-line ACT (artesunate plus sulfadoxine-pyrimethamine), anti kala azar medicines (especially new medicines), and vector resistance to insecticides;

• Pharmaco-vigilance focusing on the first-line ACT and first line medicines for treatment of kala azar ;

• Operational research and impact evaluation; • Periodic Technical Program Reviews for malaria control and kala azar elimination led

by WHO. In the above list, activities (a)-(c) will be the main responsibility of malaria technical supervisors (MTS) and kala azar technical supervisors (KTS), who will be science graduates recruited and trained for this work and employed on a contractual basis. Depending on the population size, there will be 4-6 MTS/KTS per district. These supervisors will also be trained to support activities (d) and (e). The additional activities in the above list will be done with the help of

48

institutions under the Department of Health Research, especially the National Institute for Malaria Research (NIMR) for malaria and the Rajendra Memorial Research Institute (RMRI) for kala azar. As most of the malaria high-burden districts in India are supported financially by either GFATM or IDA, it has been agreed between NVBDCP, GFATM and IDA that the development of new M&E systems and mechanisms will be fully harmonized over the districts concerned and will gradually, based on lessons learnt, and with due consideration of different needs in districts with lower endemicity, be adopted nationwide in malaria control. Thus, for example, MTSs will have the same training and responsibilities across GF and IDA supported districts. The kala azar elimination initiatives however will be limited to GOI and IDA support in the endemic districts for kala azar. The above activities are elaborated in the following.

(a) Strengthening of HMIS Malaria surveillance is one of the strongest parts of the national malaria control program. Based on the examination of about 100 million blood slides per year, covering all endemic districts, it provides information on trends in malaria incidence and the geographic distribution of the disease in the country, but not absolute size of the burden. Strengthening of the disease surveillance and operational data management will take place as follows:

• The introduction of RDTs and ACTs will by itself improve data quality by attracting more patients to public services (and temporarily increasing the recorded annual case-load). A protocol has been devised to dove-tail the RDT data with microscopy at all levels. In the case of kala azar similar results are likely to accrue following the introduction of ‘Rapid Diagnostic Test for Kala azar’ for diagnosis and new first line drugs that are very effective and safe.

• New streamlined formats, including computerized data management from the block level and upwards have been prepared for piloting in three districts from June to September 2008. These formats allow, for example, monitoring of proportion of villages with a provider of RDTs and ACTs and the comparison of operational data on coverage in populations at risk with data obtained through surveys and LQAS. Similar activities will be undertaken by the kala azar technical supervisors in the project areas to monitor the coverage and quality of case management services.

• A protocol under preparation will be used by MTS to check data completeness of both surveillance and operational data on a sample basis at all levels in the district. During supportive supervision, a kala azar treatment supervisor will validate the data of the general health workers.

• Revision of the web-based management information system, NAMIS, which was introduced a few years ago, but has poor functionality due to poor connectivity in districts and lack of follow up.

GIS is already being used in malaria control and kala azar elimination programs on a limited scale and this will be further strengthened and will be used for more effective planning of the

49

spraying activities in the district. GIS will be utilized to track the progress of elimination of kala azar.

(b) Sentinel surveillance

One of the main weaknesses of the existing malaria surveillance is the lack of articulation with hospitals, which means that severe malaria cases are not reported separately (if at all) and that only a small fraction of malaria deaths are recorded.27 Therefore, sentinel surveillance will be established, by selecting, in each district, 2-3 health facilities with high malaria case-loads (these can be private or mission hospitals) for recording of all in-patients with malaria and malaria-related deaths introducing classification according to rigorous criteria. For kala azar in each district 3 hospitals/health centers will be selected for undertaking sentinel surveillance where detailed information will be collected. Besides detailed information on patients who are treated at home the sentinel surveillance will also provide information on patients of kala azar who are hospitalized and include case fatality rates.

(c) A rapid population-based survey system including the LQAS method This will be established in each participating district to track coverage and use of LLINs, RDTs and ACTs at the PHC level on an annual basis. Similar tracking in kala azar will be done for ‘Rapid Diagnostic Test for Kala azar’, first line medicines and treatment completion. It will also be used to assess IRS coverage. LQAS is a rapid survey used by district managers to determine whether Primary Health Centres (PHC) are reaching pre-established targets for key project indicators. The same data can be used to calculate point estimates for outcome indicators for district and project levels. The project will explore the possibility of using hand held computers or tablets for rapid data entry and to avoid information bottlenecks. Data for a decision-making component will be established to determine underlying program problems identified with LQAS. All data will be used during annual work planning sessions to restructure and improve the project, as well as to set targets for the subsequent year. To ensure the accuracy of the information collected a small sample of questionnaires will be sampled and the corresponding interviewee, interviewed again. By counting the concordant pairs, the reliability of the data can be established. The data collection and preliminary analysis will be carried out by MTS. The LQAS is being used because it requires the least amount of information to judge whether outcomes are on track at the PHC level. This is due to its small sample size requirements. The following describes the process in more detail. Each District (N=1.2 to 1.5 million population) will have approximately 6 MTSs or 6 KATS whose primary job is program monitoring and supervision. As per NRHM norms each District consists of approximately 45 sectors (PHC areas, “new PHC” areas) with a population of 20-30,000, so there are about 15 sectors per MTS. Each PHC area is comprised of approximately 30 villages (N=1000 each). All LQAS analyses will be at the PHC level and measure key project indicators using focused mini-questionnaires. Three mini-questionnaires are currently

27 Kumar A, et al. Burden of malaria in India: retrospective and prospective view. Am J Trop Med Hyg. 2007 Dec;77(6 Suppl):69-78

50

envisioned: (a) an ITN/LLIN coverage and use module, (b) a fever management and treatment seeking behavior module, and (c) an ASHA questionnaire. The fever management module may take place in the household where the previous mini-questionnaire is used or in subsequent households. It applies only to people who have had a fever in the last 2-weeks. The third mini-questionnaire requires the MTS to contact the frontline service provider to inspect the condition of ACTs and RDTs, whether stock-outs have occurred in the last 3-months, and whether this provider can use RDTs and treat malaria correctly. Modules for use by KATS for LQAS are being developed to include client interviews, provider interviews and observation of the facilities. In order to minimize data collection the project will apply a new approach to LQAS analysis called Large Country LQAS (LC-LQAS).28 Using this approach a statistically determined sample of sectors will be made at a point in time (e.g., 15 sectors or 5 sectors per MTS). This approach will permit assessment of the 15 sectors after 5 weeks and also calculate a point estimate for the district. LC-LQAS permits the program to carry out an innovative approach to program monitoring for it can carry out 3 waves of data collection at key times of the year (e.g., at the beginning of the high transmission season, at the end of the high transmission season, and at the low transmission season. The resulting data will permit program managers to determine the stability of net use and case management throughout the year, and therefore inform program managers about priority support that is needed in PHCs. Most key program outcome indicators will be measured using the LC-LQAS data. In addition, two cross-sectional household surveys to collect the same data plus selected other variables, especially malaria prevalence, will be carried out in 2010 and 2013 across the high-burden districts (and possibly, according to NVBDCP/MOH decision) across other malaria-endemic districts. Cross sectional household and health facility surveys have been carried out for kala azar in 2006 and the findings were used in the JMM. These surveys were very useful in planning the kala azar program. Similar surveys are proposed in 2010 and 2013 to make sure that kala azar cases are not being missed out.

(d) A Logistic Management Information System (LMIS) This will be created to track LLINs, insecticides, RDTs and ACTs from their purchase or point of entry into India and the project districts through to the decentralized distribution points in the PHC areas. For kala azar it is proposed to include ‘Rapid Diagnostic Test for Kala Azar’, and first line medicines. The LMIS will use a standardized form that records the quantity of LLINs, RDTs (or ‘Rapid Diagnostic Test for Kala Azar’) and ACTs (or first line medicines for the treatment of kala azar) at each point where an organization takes delivery or delivers these commodities. The LMIS tracks the distribution of the products down to the lower sub-district

28 Bethany Hedt, Casey Olives, Marcello Pagano, Joseph J. Valadez, “Large Country-Lot Quality Assurance Sampling: A New Method for Rapid Monitoring and Evaluation of Health, Nutrition and Population Programs at Sub-National Levels.” The World Bank. (In Review 2008). LC-LQAS has already been used in Eritrea, Kenya, Nigeria and Uzbekistan.

51

level service delivery points. Each district will be responsible for tracking its own allotments but will be required to use one reporting system and forward this information centrally to the NVBDCP. The LMIS will show the spatial distribution of LLINs, RDTs, ‘Rapid Diagnostic Test for Kala Azar’ ACTs and first line medicines for kala azar in the project area, and provide the project management with information to determine whether any area is deprived of needed commodities. The MTS/KATS or a different person (e.g., a designee or agent of the DMO) will annually sample the LMIS data and verify the chain of transactions from the time of delivery in the district down to service delivery points in PHCs to authenticate the information. This same agent will assess the quality of ACT/RDT, ‘Rapid Diagnostic Test for Kala Azar’ or first line medicines for kala azar and vector control supplies storage facilities. The LMIS will not track the distribution of LLINs and ACTs to patients as that is the role of the HMIS. MOHFW is in the process of establishing a comprehensive LMIS for the health sector with support from DFID in three states. Two of these states where such piloting is taking place are also malaria endemic states proposed to be included under the project (Orissa and Madhya Pradesh) and efforts will be made to ensure integration of the project LMIS with this initiative.

(e) System to monitor the quality of rapid diagnostic tests and medicines to ensure their quality upon delivery and at point of use

NVBDCP has prepared a protocol for monitoring the quality RDTs in accordance with WHO recommendations and technical documents. This will now be translated to an action plan, which includes the training of a limited number of laboratory technicians in each state, who will sample and control RDTs. Similarly, a protocol will be established for quality assurance of antimalarial medicines (especially ACTs), which will be sampled according to established and approved protocols in the context of the work described under (d). Quality assurance of ‘Rapid Diagnostic Test for Kala Azar’ and first line drugs used in the treatment of kala azar will be undertaken with the help of the RMRI Patna. Help will be taken from the Regional Directors for implementation.

(f) Monitoring of parasite resistance to antimalarial medicines, in particular the first-line ACT (artesunate plus sulfadoxine-pyrimethamine), Miltefosine and of vector resistance to insecticides

With the adoption of an ACT including the long-acting sulfadoxine-pyrimethamine (SP) as a component, close resistance monitoring including molecular markers becomes essential. This work will be led by the National Institute for Malaria Research (NIMR), which has established a protocol in collaboration with NVBDCP. ACT therapeutic efficacy and molecular markers for SP resistance will be collected from 30 sites, where patients will be sampled and examined every second year in each site. In addition, susceptibility of P.vivax to chloroquine will be monitored in 3-4 of these sites. Monitoring of resistance to Miltefosine will be undertaken in 3 sites by rotation and RMRI will be involved in oversight of this activity. Monitoring of insecticide resistance across the country has been extremely weak for many years despite the availability of trained entomologists in research centres. A protocol has been established by NIMR in collaboration with NVBDCP to assess over a 5 year period, the susceptibility of anopheline vectors to the main insecticides in use in 120 sites, which will be selected to be representative of the malaria-ecological patterns in the country. DDT continues to

52

be used for kala azar elimination. To date, widespread resistance has not been reported but continued vigilance to determine development of resistance is necessary. Protocols will be developed by RMRI and in collaboration with the Regional Directors. Insecticide resistance studies will be undertaken in at least 3 sites every year and these sites will be selected in consultation with the affected states.

(g) Pharmaco-vigilance focusing on the first-line ACT and Miltefosine As ACT and Miltefosine are newly adopted in India on a large scale, it is important to monitor safety in the program conditions. In due course, new partner drugs may be considered for ACT and Paromomycin may be added in the list of first line drugs for kala azar treatment. The routine pharmaco-vigilance system is not able to effectively monitor the safety of these new medicines in endemic areas, where a small minority of patients see a medical practitioner. A protocol for prospective monitoring, coordinated with drug susceptibility testing, in 5 sites has therefore been established by NIMR and similarly pharmaco vigilance will be undertaken in 3 districts included under the kala azar elimination program.

(h) Operational research and impact evaluation A list of priorities for operational research under this project has been established. The research projects will be carried out by research institutes based in India, where appropriate, in collaboration with overseas partners. The list includes:

• Use of different equipment (especially compression sprayers instead of the obsolete stirrup pump) for IRS for vector control in malaria and kala azar programs.

• Assessing the reliability of RDTs for vivax malaria. • Validation of new diagnostic kits for kala azar in field conditions. • Assessment of the efficacy and safety of newer ACTs, which may be considered as

replacement for artesunate + SP. • Evaluation of different delivery models in PPP, including private providers of curative

services in malaria control and kala azar elimination. • Assessment of different strategies for communication to promote the use of insecticide-

treated nets, especially LLINs in tribal populations including assessment of the influence of housing types and mobility.

• Study effectiveness of different options for active case detection of kala azar. • Finding best practices for ensuring complete treatment of kala azar.

In addition, protocols for two important randomized controlled studies have been developed for impact evaluation:

• Assessment of the effect of delivering one net per household as a start and one net a year later, compared to delivering two nets from the outset. The hypothesis is that staggered delivery might be associated with higher usage rate and lower risk of being sold.

• Assessment of the effect of strengthening supervision of ASHAs and other village volunteers providing curative services by increasing the number of supervisors to the point, where each volunteer is supervised monthly.

53

(i) Joint Technical Program Reviews led by WHO The Indian malaria program has a long tradition of inviting external partners led by WHO to join in thorough evaluation exercises. These have been of great utility in some instances. The latest, which took place in late 2006/early 2007 was of crucial importance for introducing the new policies, which will be piloted and taken to scale through this project. NVBDCP now plans to undertake such exercises again in 2009, 2011 and 2013 and will request WHO to set up a team to provide the external expertise. The emphasis in 2009 is expected to be effectiveness, efficiency and quality of implementation rather than policy issues. B. The Polio Component Scope of SIAs in India. During each NID, about 172 million children are immunized. Nearly 2.3 million vaccinators under the supervision of 155,000 supervisors visit 209 million houses. For SNIDs the number of children depends on the state covered but in UP and Bihar 37 and 30 million children are immunized in each SNID. Monitoring System in India: An independent monitoring system is in place to identify the gaps in preparedness and implementation of the SIAs. Independent monitors include the following: Consultants from WHO and CDC; NPSP surveillance medical officers (SMOs) and technical staff from NPSP Delhi; Field volunteers and other monitors hired locally by SMOs. The total number of monitors deployed during each NID is nearly 3500. Of these, 35% are deployed in UP and 22% in Bihar. The monitors are deployed for the entire duration of the campaign i.e. 6 to 7 days in UP and Bihar and 3 days in rest of India. In UP and Bihar nearly 420,000 houses (1% of the total) and 11,000 vaccination teams (8% of the total) are monitored during each round by these monitors Monitoring during the Preparatory Phase: During the preparatory phase, monitors assess the quality of micro plans, training and involvement of the district and sub-district government officials in the program. If any serious problems are noted by the monitors, prompt feedback is provided to senior officers at the state levels to address them. At the district level, the monitoring information is shared during the district task force meetings chaired by the district magistrate and attended by the Chief Medical officer of the district. Feedback from monitoring is also provided to the divisional commissioners and to the state secretaries. In addition, a Polio Operations Group monitors the vaccine supply and logistics regularly while the Social Mobilization Group provides oversight for BCC activities.

Monitoring during the Campaigns: During campaigns monitoring gives more emphasis to the areas where coverage levels are generally poor and which therefore are at a higher risk of polio transmission. Monitors assess the operational processes that influence the quality of the immunization activity such as composition, work load and training status of vaccination teams, quality of vaccine being used, involvement of local influencers and leaders in the campaign, vaccination at transit sites and other high risk and hard to reach areas like brick kilns, construction sites, riverine areas. Special emphasis is given to monitoring the vaccination and tracking of new born children. Areas with under served population are intensively monitored to asses whether services are reaching these highest risk population groups. Monitors randomly

54

visit houses to validate the coverage reports provided by the vaccination teams to look for any unimmunized children are left in houses reported to have been fully covered. Monitors also visit houses where the vaccination teams have not been able to immunize all children for various reasons such as sickness of child, refusal by parents, child away from home or house locked. Monitors make an overall assessment of the houses with potentially missed children in each area. An important activity performed by monitors during the campaign is to assist the collation, analysis and review of administrative data on each day of the activity. This analyzed information on children immunized, houses visited during the day along with the monitoring feedback drive the discussions every evening when the district magistrates, chief medical officers and other staff review the program Feedback from Monitors: Monitors provide immediate feedback on the vaccination teams and supervisors who are found to be performing poorly in the field. Generally such feedback is provided to the district and sub-district health and administrative staff either each evening during the NID or SND days or at the end of each round for corrections during the subsequent days of the current round and during future rounds. Impact of Monitoring. The impact of monitoring can be categorized into two broad groups: (i) Improved coverage during SNIDS/NIDS measured by a reduction in the number of children missed over rounds. Example: The percentage of houses with potentially missed children in Moradabad district of Western UP (the epicenter of the 2006 outbreak) reduced from 14% in late 2005 to 7% during 2007; and (ii) Concurrent monitoring to help program implementers to make tactical changes in the strategy to reach the children at highest risk. Newer initiatives such as new born tracking, covering migratory populations, ensuring revisit of vaccination teams to houses where children have been missed are a result of the monitoring findings. Examples of data being collected and used for action.

Percent houses with potentially missed children – Moradabad district (West UP)

Percent teams tracking and immunizing newborns by district – UP, November 2007

55

Monitoring of Vaccine Quality. While vaccine purchased through UNICEF is from WHO pre-qualified manufacturers, each batch is also tested by the National Laboratory in Kasauli. In addition Vaccine Vial Monitors (VVMs) on separate vials alert the end user to any problems in the cold chain thereby assuring vaccine efficacy.

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Annex 3B: Impact Evaluation (VBD)29

Executive Summary The impact evaluation studies conducted under the NVBDCP will generate valuable evidence to assist in the realization of two important goals in disease control efforts: (a) to increase the number of people benefiting from effective prevention, including the promotion of LLINs, and (b) to provide timely diagnosis and treatment services for malaria control, most notably through the introduction of ACT in endemic areas. Impact evaluation will be used to investigate the effectiveness and cost-effectiveness of alternative strategies in disease control efforts to be evaluated against expected NVBDCP activities and will be conducted in the first two years of the project to inform policy going forward. Described below is the summary of the interventions, one concerning case management and one involving the distribution of LLINs. Case Management Under the new program, the NVBDCP will introduce the revised policy for malaria diagnosis and treatment in a phased manner, prioritizing states and districts with high PF burden. With the help of the existing structures of the NRHM, ASHA or other Voluntary Health workers already available at the village level will serve as the local frontline representative for fever/malaria control and will dispense ACT to PF confirmed fever cases. To assist the ASHA in her efforts, the NVBDCP will create the position of the Malaria Technical Supervisor (MTS), who will be fully devoted to the control of malaria in high-burden areas. Per program design, the NVPDCP will hire 6 MTS at the district level who in turn will support roughly 1000 ASHA workers. ASHA responsibilities are numerous, including family planning, nutrition, and vaccination. These multiple burdens raise the distinct possibility of under-performance with regards to malaria treatment and control. The case management component of the impact evaluation will evaluate the effectiveness and cost-effectiveness of enhanced saturation of MTS to supervise the ASHA worker on a more regular basis in order to explore whether and to what extent ASHA performance will benefit from more intensive training and supervision. Under this design two MTS will be posted at the block level and each individually will be responsible for 75 ASHA workers. This ratio of MTS to ASHA workers ensures that the travel burden of each MTS will be greatly reduced and that each ASHA worker will be directly supervised at least once monthly. Supervision will also include BCC for villagers in her catchment area, and a strengthened supply chain of key malaria control commodities such as RDTs and ACTs with the aim of minimizing stock outages and commodity leakages from health center stores. Distribution of LLINs National policy for the use of LLINs is currently crystallizing on a position to scale up as rapidly as possible for universal coverage of LLIN target populations. Presently, the target population is

29 This activity is being financed as a separate non-lending task and is not part of the financing provided through NVBDCP although its planning and implementation are coordinated with the project.

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a village or sub-center area with intense transmission (indicated by API above 5/1000), and poor accessibility for IRS operations (for example, roads inaccessible during the rainy season). The early years of the project provide the opportunity to evaluate alternative models of distribution and social mobilization activities. In this group of evaluations, the control will be constituted by the expected NVBDCP policy of public sector distribution of two LLINs to each household at no cost. Against this control activity, two potential modes of distribution aimed at increasing the total coverage and proper usage of LLINs will be compared. These two activities are:

(a) Priming households with the free distribution of one LLIN to households the first year, followed up by another LLIN distributed in the following year (i.e., a 1+1 vs 2 approach).

(b) Free LLINs distributed to all households through cooperation with local community based organizations, notably self-help-groups (SHGs).

The first treatment intervention will test the effect that experience of one net by the household has on their take up of the second net in the following year. Given that LLINs are scarce in comparison with the size of the eligible population, effective coverage may possibly be higher if only one net per household were distributed initially since twice as many households will be covered. Furthermore, if a “priming” effect on net adoption, through direct experience, is important then higher usage rate may be achieved if nets are delivered in an incremental scheme rather than all at once. This approach will also have the additional benefit of reducing the household incentive to sell freely provided valuable goods to local markets. In the second intervention, local SHGs will work with the government distribution mechanisms and take responsibility for social mobilization efforts as well as the monitoring of LLIN distribution and initial use. SHGs have traditionally been a small group of persons (primarily women) who come together with the intention of accessing micro-credit programs. SHGs may afford easy and credible access to the community, and thus have the potential of playing a significant role in strengthening prevention activities at the village level. Size of Study Power analysis indicates that a sample of 4,350 households will be sufficient to detect moderate improvements in net usage and fever treatment at standard levels of statistical significance. 1,050 of these study households (in 35 villages) will be located in blocks that receive the case management treatment of additional MTS and 1,050 will be in comparable and randomly selected control blocks. Villages in additional blocks will be randomly assigned to one of two prevention treatment arms or the prevention control. Each arm of the prevention treatment will involve a sample of 750 households distributed across 30 villages. Data Collection and Analysis The survey data will be collected in two phases. Baseline data collection will occur during September – November 2008, the peak transmission season following the rainy period.

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Intervention activities will then commence in the January – March period of 2009. Follow-up surveys with the same households will be fielded exactly 12 months after the baseline in September – November 2009, and then again in 2010. The follow-up survey will be partly based on the baseline survey instrument but will also record detailed information on the household responses to the experimental intervention in terms of adoption and behavior change. The data will be collected using a professional survey team and will be entered in India with sufficient safeguards being taken to ensure accuracy and respondent privacy. Supplementary information will be provided by the HMIS. As soon as preliminary results are validated they will be shared with the NVBDCP directorate.

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Annex 4: Detailed Project Description

The project will support GOI to implement evidence based interventions for the control of malaria and elimination of kala azar covering districts with the highest burden of these diseases in a phased manner. Support for strategic planning and institutional development will also be provided to endemic districts and states in evolving programs relevant to their needs and implementing them effectively. There will be special emphasis on strengthening monitoring and evaluation systems to assess the impact of innovations to improve service delivery. The project will be implemented over a five-year period, from 2008/09 to 2012/13, a large portion of which coincides with the 11th Plan period (2007/08 to 2011/12). The broad outlines of the project were drawn in a document produced by the Directorate of VBDCP, the “Draft Concept Note for the Proposed Enhanced Vector-Borne Disease Control Program, 2005-2010”, which evolved through a consultative process led by the Directorate and with active participation from the States, non-governmental organizations (NGOs), civil society, WHO, GFATM, and other Development Partners currently supporting the control of vector-borne diseases in the country. The main program characteristics envisaged by the NVBDCP are:

• The program will use evidence-based national policies and strategies for prevention and control of vector borne diseases. 30

• The states and districts will be given adequate flexibility to plan and implement the national policies and strategies as per their specific needs, environmental and social conditions and capacities.

• Central budget allocations will be based on state plans (which in turn are based on district plans) and not just population-based norms.

• There will be a stronger focus on program performance. Every state plan will be driven by a clear log frame that links outcomes and outputs to program inputs and processes. States will ensure similar emphasis in their district plans.

• State plans will prioritize high-burden areas while maintaining vigil in low and non-endemic areas, and will ensure better harmonization of surveillance and service delivery with other initiatives supported under NRHM such as the Integrated Disease Surveillance Program (IDSP).

• High priority will be given to strengthening program management at state and district levels and supportive supervision at sub-district level.

• The state Departments of Health and Family Welfare, in addition to implementing national policies and strategies for prevention and control of vector-borne disease, will partner with other departments or NGOs/private sector to improve access and quality of care.

• The NVBDCP, especially at the state level, will play a greater stewardship role and assume the responsibility of oversight to seek uniformity in the application of best practices by NGOs and other private health care providers.

30 An article in the international journal The Lancet was critical of the India Malaria Control Program and Bank support of it for not being more proactive in introducing new technologies to address India’s changing malaria situation. GOI’s current malaria strategy addresses many of the issues raised in that article and the Bank supports these policies through this project. See The Lancet April 25, 2006, on line DOI:10:1016/S0140-6736(06)68545-0.

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The following table summarizes the key innovations being put in place by the project and some remaining concerns and issues:

Table 1: Technical Innovations in VBD Program and Challenges Intervention and Current Status Agreed Change in Policy/Program Comments/Challenges Malaria Case Management � Presumptive chloroquine treatment no longer effective for increasing falciparum malaria (Pf) prevalence � Community-level diagnosis based on microscopy not available or delayed in rural and tribal areas

� Confirmed Pf cases to be treated with ACT, a new, highly effective drug regimen � Rapid diagnostic test kits to be introduced at community level and used to confirm Pf within 24 hours of fever onset

� ACT treatment requires new training and supervision � Higher commodity costs � Need to assure adequate supply and storage in remote areas � Need to assure quality of drugs and medical supplies in booming global market

Malaria Vector Control � Mosquito control traditionally with insecticide spraying in houses (IRS). Effectiveness has declined due to vector resistance

� Program will replace over time most IRS with use of long-lasting insecticidal mosquito bed nets (LLIN). Delivery free to villagers.

� LLINs not yet widely accepted by beneficiaries – need strong behavior change activities � LLIN production in India still limited. Need to develop market

Kala Azar Case Management � Rapidly increasing resistance to currently used inject able medicines for Kala Azar which also have significant side effects � Current tests to diagnose Kala Azar are not very specific

� New oral drug – miltefosine – which is safer and more effective to be introduced in districts where there is high resistance to current drugs. � New A Rapid Diagnostic Test for Kala azar test kits to be used to improve diagnosis � Successful strategies from TB program to be used to increase patient compliance

� New strategies will require better implementation in some of India’s weakest districts � Miltefosine must be closely monitored as it is toxic to pregnant women and small children � Adequate supplies and logistics must be assured in difficult areas � New technologies are higher cost and may result in low quality imitators which must be kept away from program

Kala Azar Vector Control � Kala Azar vector, the sandfly, now poorly controlled with DDT

� DDT application to be strengthened with new approaches to identifying high prevalence areas � Training and supervision of control workers to be improved � Collaboration with local housing and sanitation programs to be increased.

� New strategies require additional staff support and better monitoring and supervision in weaker locations

Overall Program Management � Current program implemented in many states � Widespread implementation with little attention to capacity or preparation � Weak monitoring � Slow introduction of expert advice

� Project will focus on states with more affected districts � Project will introduce district level readiness filters prior to implementation � Strengthened HMIS plus focused sample and survey reviews � Biannual technical reviews with WHO leadership

� New processes need to be scaled up. Project will expand in two phases with major progress review before two years � Additional staff support needed for implementation. Project will finance local staff, mobility, and training which will eventually be adopted into government system

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The discussion below summarizes the main objectives, activities and reforms planned by the NVBDCP for malaria control and kala azar elimination supported by the project. Malaria Control

1. Phased Implementation Focusing on High Burden Districts: The NVBDCP will introduce the new policy for malaria diagnosis and treatment recommended by the 2007 Joint Monitoring Mission (JMM) in a phased manner, prioritizing States and districts with high Pf burden. Apart from 94 districts in North-eastern States, which are already covered by GFATM support for malaria, 93 districts in the country with high Pf malaria incidence have been selected for the proposed project.

2. Improved Access to Malaria Case Management: All project districts will first be

stratified according to the risk of Pf malaria in each PHC block. In PHC blocks with Slide Falciparum Rate (SFR) >= 2%, all fever patients will have an RDK for Pf, except if a microscopy result can be available within 24 hours. In other PHC blocks, an RDK will only be used for patients at high risk. This selective use of RDKs will make diagnosis of Pf malaria more cost-effective. The proposed changes will have important implications for the commodities to be procured by the program, especially RDKs, and ACTs, and in terms of training, M&E, and quality assurance.

3. Supporting Innovations in Malaria Surveillance: In surveillance, the project will support

efforts to de-emphasize the collection of blood samples through outreach workers –i.e., Active Case Detection (ACD). Such collection will be restricted to high-risk areas with weak curative services, and when there is suspicion of an outbreak. In project districts, surveillance will be primarily based on the examination of blood samples from suspected malaria cases i.e., Passive Case Detection (PCD). In the initial phase, States will set tentative annual targets for the number of patients to be tested in PCD (e.g.. at least 10% in highly endemic areas); when more experience has been gained NVBDCP will prepare norms adapted to different epidemiological situations. In the initial phase, blood slides will be collected from all patients suspected of malaria, whether or not an RDK test is also given. This will ensure continuity in surveillance and support quality control of the two methods of confirmatory diagnosis. After two years, the need for taking blood-slides will be reviewed. By then it is likely that RDKs sensitive to Pf as well as PV will be available. In addition, the project will support the introduction of a sentinel surveillance system in the NVBDCP to monitor hospital admissions and deaths attributable to malaria at selected representative sites including those from government and in the private sector, and periodic surveys of health facilities and households in endemic areas.

4. Monitoring of Anti-malarial Drugs and Insecticides Efficacy: The project will support

nation-wide actions to update and strengthen monitoring of therapeutic efficacy of anti-malarial medicines, insecticide resistance and quality of medicines to contain the problems of drug and insecticide resistance and ensure their efficacy. Monitoring of therapeutic efficacy of SP and ACTs will be undertaken so that effective drugs are used in the treatment of malaria. To maintain the use of effective drugs and get the desired impact, at least five units will monitor the quality of medicines and insecticides at different sites in the country. One

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unit in each state will be responsible for quality assurance of diagnosis. In addition, there will be an independent inspection agency monitoring the quality of pharmaceuticals by testing random samples.

5. Enhancing Effectiveness of Existing Vector Control: The project will also support

improvements in the effectiveness of its vector control operations in high Pf high burden districts by introducing micro-stratification of districts according to revised national guidelines based on epidemiological and ecological data, to delimit areas and populations which will be targeted for selected interventions, i.e., IRS or LLINs. Furthermore, the program will systematize insecticide rotation for IRS to lessen the risk of insecticide resistance and ensure the implementation of good pesticide management practices. The use of IRS will be restricted to those high risk areas where LLINs are unacceptable for the population or there is other evidence for superior effectiveness of IRS and for the control of epidemics with a focus on quality and completeness of IRS coverage.

6. Introduction of Long Lasting Insecticidal Nets (LLINs): Another important thrust of the

program in the 2008/09-2012/13 period will be promoting the use of LLINs. Areas consistently reporting high Annual Parasite Incidence (API) in all age-groups (indicating intra-domiciliary transmission) will be given priority in this regard, with a target of achieving 80 percentage coverage. The success of this thrust will require effective BCC strategies for proper use and demand generation. Current BCC activities lack focus in objectives, media, messages and target audiences; there is a lack of clear articulation of the behaviors to be changed and most BCC activities are input based with limited attention to desired outcomes. A BCC Strategy and Action Plan will be prepared before the Board approval. LLINs will, in the first years, normally be distributed by the public sector free of charge (possibly through performance contracts with NGOs), but it is expected that a progressively larger share of nets will be distributed through public-private initiatives (social marketing), with the government providing a partial subsidy, depending on household economy in a given area.

Eliminating Kala Azar

1. Improving Access to Quality Kala Azar Diagnosis and Treatment Services in Endemic Districts: The project will support efforts of NVBDCP to achieve the goal of eliminating kala azar by 2010 focusing on 46 districts the three States that account for practically all kala azar cases in India (Bihar, Jharkhand, and West Bengal). Specifically, the project will provide inputs to improve access to better-quality and more specific diagnosis and treatment of kala azar patients, mainly by introducing Rapid Diagnostic Test for kala azar dipsticks in the government health services (for appropriate diagnosis of the disease), and the use of effective new first-line drugs such as miltefosine and paromomycin (after its approval). These measures will be accompanied by the required staff training and intensive monitoring of each case.

2. Improving Quality of Kala Azar Case Management in Private Sector: In addition to

improving services in the government sector, the program will seek to establish public-private partnerships with private health care providers whenever feasible.

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3. Supporting Supply-side Interventions for Kala Azar: The project will support piloting of supply side interventions, backed by expanded BCC efforts to educate the public in endemic areas and to motivate infected persons to seek treatment from qualified providers at an early stage of the disease. Because many kala azar patients are very poor, the project will support innovations such as cash subsidies to patients to compensate for the loss of income during kala azar inpatient treatment.

Behavior Change Communication A three pronged BCC strategy is proposed for the NVBDC program: This includes: (a) a decentralized BCC activities financed by GOI; (b) central BCC activities implemented by a professional media agency to be financed by the project; and (c) social mobilization activities with specific focus on promoting LLINs to be implemented by NGOs or social marketing agencies with a strong field presence also financed by the project. The decentralized locale-specific BCC activities are detailed in the operational guide for anti-malaria month campaign. This document provides a clear roadmap for initiating and implementing structural and institutional framework for implementation as well as institutional arrangements and monitoring and evaluation processes along with a budget template. However, random state visits undertaken during the project preparation suggest that implementation capacities across the states vary widely. While this activity is primarily financed by GOI, the project will provide consultant support at state and national levels and the primary focus will be on interpersonal communication and group discussions to inform community based institutions like Panchayat Raj and self help groups, and vulnerable populations about new diagnostic and treatment services made available at the village level. A professional media agency will be selected following the QCBS process at the national level to undertake formative research, develop and pre-test multi-media campaign and undertake media buying for a nation-wide campaign with strong focus on endemic states. The project also provides for hiring services of NGOs and social marketing agencies which, having a strong field presence, will be used to undertake social mobilization of beneficiaries in villages selected for LLIN intervention. Training The focus will be on competency based and inclusive training (see Table 1 in this Annex ). The program has well defined operational guidelines for each cadre of staff and a well defined training plan supported by clear operational guidelines. Under the project, additional consultant support for training has been provided at national and state levels to ensure effective planning and oversight for decentralized training activities. National trainers for malaria and kala azar have been trained by a team of experienced national and international experts, and this opportunity has been used to update the training modules. The national trainers, in addition to training the core vertical contractual staff proposed under the project (such as malaria and kala azar technical supervisors and the district VBD officer and consultant), will also monitor the quality of training. One dedicated NVBDCP focal point has been identified for each project state who will regularly visit the state to provide technical oversight for decentralized activities and for trouble shooting. Further, an independent agency will monitor the physical progress of decentralized training including compliance with the program guidelines. The proposed early implementation review will also assess the competencies of the staff at different levels.

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Project Components and Sub-Components The project will have four components: (a) Improving Access and Use of Malaria Prevention and Control Services; (b) Supporting Elimination of Kala Azar; (c) Policy and Strategy Development, Capacity Building and Monitoring and Evaluation; and (d) Polio Vaccine Supply. The first two components will include activities implemented by the Directorate of the NVBDCP, as well as activities implemented by the states (on the basis of approved annual state action plans), but financed by the central government, either in the form of in-kind transfers or cash transfers through state health societies.31 In addition to the project components, approximately US$36.5 million has been included in the project as unallocated funds. This will be available to support a more rapid scale-up of project interventions, such as LLINs if possible, as well as a contingency fund in the event that proposed finances from GFATM are not available and there is agreement on fiduciary arrangements acceptable to IDA for NGO contracting and public-private partnerships. Project Component 1: Improving Access and Use of Malaria Prevention and Control Services [US$119.5 million] This component includes activities to be implemented by the NVBDCP Directorate and by the states and will finance the supply of pharmaceuticals, diagnostic kits, lab consumables, insecticides, long lasting insecticide treated nets (LLINs), medical equipment, computer hard and software, furniture, training, IEC/BCC materials including operating costs and consultant support. It comprises four sub-components:

• Sub-Component 1a: Improving Malaria Case Management • Sub-Component 1b: Strengthening Malaria Surveillance • Sub-Component 1c: Effective Vector Control

Sub-Component 1a: Improving Malaria Case Management The NVBDCP will introduce the new policy for malaria diagnosis and treatment, in a phased manner, prioritizing states and districts with high Pf burden. Apart from 94 districts in north-eastern States covered by GFATM support for malaria, 93 districts in the country with high malaria burden have been selected for implementation of the new policy and related reforms. Access to early diagnosis of Pf based on RDKs will be implemented in 50 districts during the first two years to develop and refine implementation models while only minimal inputs will be provided to the remaining 43 districts. Within these districts the new treatment policy will first be implemented at sub-centre and primary health centre levels and expanded to the village level after a year as the competencies of ASHAs and other community-based workers are adequately developed. After the early implementation review, the new model will be implemented in the remaining 43 districts from the third year to cover the 93 districts. The scaling-up, however, will be subject to satisfactory implementation. This sub-component will also include training and improved supervision with special focus on new tools for effective diagnosis and the treatment of 31 The State Governments, through their Departments of Health and Family Welfare, will continue to provide staff and operational support for the program, but these expenditures are not included in the project.

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malaria; behavior change communication to promote appropriate treatment-seeking and adherence; promotion of appropriate case management in the private sector and innovations such as social marketing/franchising for private sector involvement. The household surveys planned under the project will provide data on access. Sub-Component 1b: Innovations in Malaria Surveillance The project will support efforts to reduce emphasis on the Active Case Detection (ACD) and surveillance in the project districts will primarily be based on Passive Case Detection (PCD) which involves examination of blood samples from suspected malaria cases reporting to a provider or a facility. The ACD will be restricted to high-risk areas with weak curative services and suspected outbreaks. To assess the operational feasibility of this approach, tentative annual targets for the number of patients to be tested in PCD (e.g., at least 10% in highly endemic areas) will be set by the project districts initially and after gaining some experience, the NVBDCP will prepare norms for PCD in different epidemiological situations. To understand the malaria trends, the project will support a sentinel surveillance system to monitor hospital admissions and deaths attributable to malaria at selected representative sites covering both public and private sectors, and periodic morbidity surveys in endemic areas. Sub-Component 1c: Effective Vector Control The project will support micro-stratification of districts based on epidemiological and ecological data for more effective targeting of IRS or ITN operations. In the project districts the national policy of insecticide rotation for IRS will be introduced to lessen the risk of insecticide resistance and good pesticide management practices will be supported. The use of IRS will be restricted to high risk areas where ITNs are unacceptable to the population, or if there is other evidence for superior effectiveness of IRS. It will also be used for the control of epidemics with a focus on quality and completeness of IRS coverage. Another project thrust will be the promotion of the use of Long Lasting Insecticidal Nets (LLINs). Areas consistently reporting high API in all age-groups - indicating intra-domiciliary transmission - will be given priority for this, with a target of achieving 80 percentage coverage. The success of this thrust will require effective BCC strategies for demand generation and proper use. The LLINs, expected to be available from the second year of the project, will be distributed by the public sector free of charge, possibly through performance contracts with NGOs. However, the project will support efforts to enhance net distribution through public-private initiatives such as social marketing, with the government providing a partial subsidy, depending on household economy in a given area. Project Component 2: Supporting Elimination of Kala azar [US$41.9 million] This component will support GOI’s efforts to eliminate kala azar by financing the supply of RDT for kala azar dipsticks, pharmaceuticals, training, insecticides, IEC/BCC materials, equipment, furniture, transport, computer hard and software, incremental staff, honorarium for community mobilizers, and operating costs and consultants in 46 kala azar endemic districts. It comprises three sub-components:

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• Sub-Component 2a: Improving Kala azar Case Management • Sub-Component 2b: Strengthening Kala azar Surveillance • Sub-Component 2c: Effective Vector Control

Sub-Component 2a: Improving Kala Azar Case Management: Activities supported by the project will include: (a) effective and free diagnosis and treatment by supplying RDT kala azar dip-sticks, oral Miltifosine and Paromomycin injections32, providing treatment completion cards and training of health care providers and their supervisors; (b) behavior change communication at the local and national levels; and (c) strengthening of management at state and district levels, and provision of additional staff at sub-district level to enhance supportive supervision and monitor treatment outcomes. The project will support these intensive efforts to eliminate kala azar in 16 districts during the first year. Based on implementation experiences, the number of districts supported by the project will be increased to 32 in the second year and 46 in the third year. All these 46 districts will be covered in the last three years of the project. Subcomponent 2b: Innovations in Kala Azar Surveillance: Passive surveillance is proposed to be strengthened at each level of health care in the districts through capacity development and use of simple formats for reporting. The scope of reporting will be enlarged by including reporting from the private sector and the NGOs. This will be supported by establishment of sentinel surveillance sites for getting accurate information on severe cases who are hospitalized and the case fatality rates will be calculated. A system of line listing will be used by sentinel surveillance sites. The strategic thrust in active surveillance will be on case detection around the reported cases through active case search. Other suitable options will be explored including the use of kala-azar fortnights if they are found to be cost effective. To validate the information provided and to facilitate planning, it is proposed to support household and health facility surveys Subcomponent 2c: Effective Vector Control: It is proposed to use the Integrated Vector Management (IVM) approach which will use the best available options for reduction of transmission risk and incorporate district based planning. Mapping of areas will be used with the introduction of GIS and remote sensing for determining coverage with IRS. While IRS with effective insecticide aiming for complete and uniform coverage will be the main thrust of IVM, it is proposed to enlist intersectoral collaboration for the application of the strategy of environmental manipulation and environmental management. The success of this strategy will depend on the involvement of the communities through behaviour change communication. Project Component 3: Policy and Strategy Development, Capacity Building and Monitoring and Evaluation [US$52.1 million] Component 3 will be covering both malaria control and kala azar elimination and will include three sub-components:

32 After obtaining the required approvals.

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• Sub-Component 3a: Policy and Strategy Development • Sub-Component 3b: Capacity Building and Program Management • Sub-Component 3c: Monitoring and Evaluation

These components will provide support to contractual staff and operating costs for strengthening state, districts and block level management for scaled up services. IDA financing will provide initial support for additional contractual staff until they can be funded from the increased central and state financing for NVBDCP. Sub-Component 3a: Policy and Strategy Development The Directorate of the NVBDCP is primarily responsible for policy development and strategic planning. To facilitate these tasks, the project will complement the ongoing technical assistance from GFATM with appropriate consultant support in the areas of procurement, financial management, M&E, information technology and environmental safety. Activities organized by the unit will include the updating of evidence-based policies for prevention, diagnosis and treatment of vector-borne diseases and the translation of these policies to operational guidelines, training materials and courses; quality assurance (e.g., of RDKs and of microscopy); operations research including technology assessment (e.g., different pumps for IRS, RDKs for vivax malaria, evaluation of different delivery models in the private and public sectors); impact evaluation for malaria control (Annex 4b); periodic external reviews of the program; monitoring of drug resistance and insecticide effectiveness; assessment of quality of medicines and the promotion and establishment of public-private partnerships for the distribution of long-lasting insecticidal nets. The NVBDC Directorate will update and strengthen monitoring of the therapeutic efficacy of antimalarial medicines, insecticide resistance and quality of medicines to contain the problems of drug and insecticide resistance and ensure their efficacy. It will undertake the monitoring of therapeutic efficacy of SP and ACTs so that effective drugs are used in the treatment of malaria. For this purpose, at least five units will monitor the quality of medicines and insecticides at different sites in the country. One unit in each state will be responsible for quality assurance of diagnosis. In addition, there will be an independent inspection agency monitoring the quality of pharmaceuticals by testing random samples. This sub-component will also include strengthening of laboratory work through quality assurance for RDKs and microscopy and implementation of good pesticide management practices at all levels. Sub-Component 3b: Program Management and Capacity Building This sub-component will include activities for capacity building and management strengthening in relation to those program functions that are common to all vector borne diseases, at both the Directorate and state/district levels. At the state/district level, specific activities will include: provision of additional staff, e.g., for procurement, financial management, BCC, M&E; deployment of additional entomologists at state level; management training for state and district program teams; and integrated vector management training for inspectors and state entomologists. It will also include training, including study tours and exchange programs for

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national and state program managers. Training in insecticide management, usage and disposal will be provided to malaria officers, inspectors and spray workers respectively. Sub-Component 3c: Monitoring and Evaluation This sub-component will include activities for making computerized management information system (MIS) functional and for monitoring and evaluation-related surveys and studies. A Geographic Information System (GIS) will be introduced systematically as a tool for micro-stratification, planning, monitoring and advocacy. Activities in the sub-component will mainly be the responsibility of the Directorate, working in close cooperation with the state-level program managers. Development of a monitoring and evaluation framework and capacity development will be undertaken by NVBDCP. The key malaria control and kala azar elimination interventions under the project will be implemented in the following states and districts, with a few capacity building inputs (malaria technical supervisors and integrated vector control) being supported in all endemic districts): Malaria States Phase I-II Districts

(FY2008/09 to 2010/11) Phase – III Districts (FY2010/11 to 2013/14)

Andhra Pradesh Srikakulam, Vizianagaram, Visakhapatnam, East Godavari and Khammam (5 districts).

Chhattisgarh Korba, Ambikapur (Surguja), Koriya, Raigarh, Jashpur, Raipur, Dhamtari, Bastar, Dantewara, Kanker and Bilaspur (11 districts)

Janjgir (Champa), Mahasamund, Durg, Rajnandgaon, and Kawardha (5 districts)

Jharkhand Ranchi, Gumla, Simdega, East Singhbhum, West Singhbhum, Saraikela Kharsawan, Sahebganj, Godda, Dumka, Latehar, Pakur, and Lohardaga (12 districts).

Jamtara, Garhwa and Dhanbad (3 districts).

Madhya Pradesh Sidhi, Shahdol, Dindori, Chhindwara, Mandla, Betul, Jhabua, Balaghat and Guna (9 districts).

Dhar, Ratlam, Rajgarh, Shivpuri, Sheopur, Satna, Sagar, Panna, Jabalpur and Seoni (10 districts).

Orissa Gajapati, Jharsuguda, Kalahandi, Phulbani (Kandhamal), Keonjhar, Koraput, Malkangiri, Mayurbhanj, Nabarangapur,

Puri (1 district)

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Nuapada, Rayagada, Sambalpur and Sundargarh (13 districts).

Gujarat Nadiad, Anand, Surendranagar, Patan, Vadodara, Godhra, Dahod, Surat, Rajkot, Kachchh (Bhuj), Junagarh and Ahmedabad Corn (12 districts).

Karnataka Kolar, Tumkur, Chitradurga, Belgaum, Raichur, Koppal, and Dakshina Kannada (7 districts).

Maharashtra Raigad, Greater Mumbai, Chandrapur, Gadchiroli and Thane (5 districts).

Kala azar States Phase I and II Districts

(FY2008/09 to 2010/11) Districts to be added in second phase (FY2010/11 to 2013/14)

Bihar Patna, Nalanda, Jehanabad, Bhojpur, Saran, Siwan, Gopalganj, E. Champaran, W. Champaran, Sitamarhi, Vaishali, Darbhanga, Madhubani, Samastipur, Muzaffarpur, Bhagalpur, Munger, Khagaria, Begusarai, Purnea, Katihar, Saharsa, Madhepura, Supaul, Kishanganj, Araria, Buxar, Sheohar, Shiekhpura, Lakhisarai, and Arwal (31 districts).

Jharkhand Sahebganj, Dumka, Pakur and Godda (4 districts).

West Bengal Malda Darjeeling, 24-Parganas (N), Nadia, Hooghly, Bardhaman, Dinajpur (N), Dinajpur (S), Birbhum, 24-Parganas (South), and Murshidabad (10 districts).

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District level implementation of malaria control and kala azar elimination activities under the NVBCP In consonance with the National Rural Health Mission strategy, the NVBDCP supports a decentralized district-centered program which is responsive to local needs operating within the national policy framework. IDA will be supporting this approach with a special focus on malaria prevention and control, and kala azar elimination. Experiences of the earlier malaria project and other disease control programs, especially the Revised National Tuberculosis Control Program, will guide the implementation strategy. Typically there will be four stages in district oriented program evolution:

1. Preparatory Stage 2. Appraisal and Approval Stage 3. Initial Implementation 4. Streamlined Implementation

Preparatory Stage: This begins with a detailed review of available epidemiological data which helps in identifying and prioritizing the high burden districts. MOHFW has already completed this exercise and identified 93 districts for malaria control and 46 districts for kala azar elimination for intensive inputs under the IDA-supported project. A sensitization workshop for the district and state program managers and policy makers from 51 malaria high-burden districts and respective states was held in June 2007 to share the new national policies and strategies, and specific actions to be completed by these districts for effective implementation of the new district focused paradigm. Similar consultations involving a wider range of stakeholders including the non-government sector are planned at state and district levels. Human resource development is the third activity during this stage. The project will be providing additional human resources such as a malaria technical supervisor and a VBD consultant respectively at sub-district and district levels to enhance program implementation. This will be followed by local recruitment of these consultants, and management of training of district VBD and assistant VBD officers. Consultants will enhance capacity to prepare district VBD action plans which will include: (a) a resource mapping exercise (both government and non-government sector providers); (b) micro-stratification clearly identifying focus areas for RDK use and microscopy, and intensive IRS and INT operations as well as special strategies for reaching VBD services to vulnerable populations; and (c) phasing of project inputs relevant to district needs and capacities. For improving malaria and kala azar case management in the private sector, each project district will undertake a mapping of private providers who are popular among the communities and are known to influence overall prescription behaviors of other providers, especially the informal sector. The district VBD officer will be supported by a consultant (provided under the project) who will organize a sensitization workshop to these providers about the new policies and processes. They will subsequently visit the identified providers to assess their ability (infrastructure, staff etc.) and interest to function as accredited facilities providing quality

71

malaria and kala azar case management services. A simple check list for undertaking accreditation and a contract form will be included in the operations manual for the district program managers. The project will provide hands-on training to all accredited providers and lab technicians working with them in malaria and kala azar case management. Wide local publicity will be given on availability of quality services at these locations. The project will ensure free supply of registers, lab reagents, diagnostic kits and medicines as per the drug policy. Each accredited facility will have at least one designated staff to maintain the records like any other public facility (stock register, lab register and treatment card/register). The designated staff will provide a monthly update on the private sector to the District VBD officer after validation by the MTS. The District VBD consultant will visit each accredited provider at least once every month to assess compliance and quality of services as per the contract. This opportunity will be particularly used to reinforce good treatment practices (detailing). Part of the payment to the VBD consultant (about 25%) will be linked to the performance of the private sector both in terms of coverage and quality. For each documented cure for kala azar given by an accredited provider, the project will pay a reward (amount to be determined) to cover their operational costs and sustain their interest. The project MIS will include the accredited private facilities and data on cases treated will be disclosed at the district health office. Appraisal and Approval Stage: The NVBDCP will constitute expert teams to review the district VBD action plans using the agreed readiness filters. Additional TA support will be provided to support the districts that fail to pass the readiness filters. During the first year, focus will be given to ensure that at least 50 districts will pass readiness filters for malaria control and 16 districts for kala azar elimination. See Annex 6 for more detail on District Readiness Filters. Initial Implementation: This will be undertaken during the first 24 months in the high burden districts selected for the first phase of the project. The new MIS will be used to evolve a district score card for a comprehensive assessment and ranking of district performance. The quality assurance systems for case management (diagnosis and treatment) as well as vector control will also be piloted during this phase. A JMM consisting of external and national reviewers is planned during the first 18 to 21 months of implementation. Findings of this review will help in identifying the deficiencies in program design and suggest appropriate changes required for an effective decentralized district based VBD control program. Streamlined Implementation: Once there is a shared understanding of the appropriate design and inputs required among all key stakeholders, the NVBDCP will pass on the responsibility of appraisal and approval of district plans to the states. This process is expected from the third year of the project. With shifting of the responsibilities, the Directorate of NVBDCP will play a facilitator role. In addition to annual program reviews, there will be quarterly monitoring visits to randomly selected districts by joint teams consisting of NVBD officers and staff of NIMR with independent experts.

72

Project Component 4: Improving Vaccine Availability This component of the Credit provides adequate quality and timely supply of polio vaccine in support of the SIAs of the Polio Eradication component under the RCH II Project. The supply of vaccine of good quality and in a timely manner is the cornerstone of the supplementary immunization activities of polio eradication. The vaccine will be purchased by MOHFW from UNICEF. The details of the program are described in Annex 1B and the monitoring arrangements are outlined in Annex 3. Financial management and procurement arrangements are detailed in Annex 7 and 8.

73

Tab

le 1

: Pro

pose

d T

rain

ing

Pla

ns

A

ctiv

ity

Lev

el

Uni

t cos

t N

o of

Uni

ts

Cos

t (IN

R M

illio

n)

IN

R

Yr

I Y

r II

Y

r II

I Y

r IV

Y

r V

Yr

I Y

r II

Y

r II

I Y

r IV

Y

r V

T

otal

1

Inte

rnat

iona

l fel

low

ship

s an

d st

udy

tour

s fo

r na

tiona

l and

sta

te o

ffic

ers

Cen

tre

150,

000

5

3

2

0.7

5

0

.45

0.30

-

-

1.

50

2 N

atio

nal s

tudy

tour

s fo

r st

ate

offi

cers

C

entr

e

35

,000

1

1

11

1

1

11

0

.39

0.3

9

0.

39

0.39

-

1.54

3

Spec

ialis

ed tr

aini

ng f

or N

VB

DC

P st

aff

Cen

tre

50,0

00

5

5

5

5

-

0.2

5

0

.25

0.25

0.

25

-

1.

00

4 Sp

ecia

lised

trai

ning

for

sta

te s

taff

C

entr

e

25

,000

5

0

100

10

0

1

.25

2.5

0

2.

50

-

-

6.25

5

Prog

ram

Man

agem

ent T

rain

ing

for

Stat

e V

BD

team

s co

veri

ng d

istr

ict p

lans

, soc

ial

mob

iliza

tion,

PPP

, Sen

tinel

Sur

veill

ance

an

d Q

A

Cen

tre

100,

000

1

2

1

0

1

.20

-

1.

00

-

-

2.20

6

Indu

ctio

n T

rain

ing

of D

istr

ict V

BD

off

icer

s (f

or 3

mon

ths)

C

entr

e

20

0,00

0

82

57

1

6.40

1

1.40

-

-

-

27.

80

7 R

eori

enta

tion

trai

ning

for

Dis

tric

t VB

D

offi

cers

(O

nce

in tw

o ye

ars)

C

entr

e

35

,000

8

2

57

-

-

2.

87

2.00

-

4.87

8

Indu

ctio

n tr

aini

ng to

Sta

te E

ntom

olog

ists

in

mon

itori

ng v

ecto

r bi

onom

ics

and

IVM

C

entr

e

50

,000

1

1

0

.55

-

-

-

-

0.55

9

Reo

rien

tatio

n tr

aini

ng f

or S

tate

E

ntom

olog

ists

(O

nce

in tw

o ye

ars)

C

entr

e

25

,000

1

1

-

-

0.

28

-

-

0.28

10

T

rain

ers

trai

ning

in M

alar

ia a

nd K

A c

ase

man

agem

ent t

o IM

A tr

aine

rs (

2 pe

r st

ate

+ 4

from

cen

tre)

C

entr

e

25

,000

2

6

2

6

0

.65

-

0.

65

-

-

1.30

11

T

rain

ers

trai

ning

for

MT

S (4

per

sta

te)

Cen

tre

25,0

00

20

12

0.5

0

0

.30

-

-

-

0.

80

12

Tra

iner

s tr

aini

ng f

or K

TS

(4 p

er s

tate

) C

entr

e

25

,000

1

2

0

.30

-

-

-

-

0.30

13

T

rain

ers

trai

ning

in S

ever

e M

alar

ia C

ase

Man

agem

ent (

2 pe

r st

ate)

C

entr

e

25

,000

1

6

0

.40

-

-

-

-

0.40

14

T

rain

ing

for

MT

S (f

or 1

0 da

ys)

Cen

tre

10,0

00

300

258

3.0

0

-

2.58

-

-

5.

58

15

Tra

inin

g fo

r K

TS

(for

10

days

) C

entr

e

10

,000

9

6

96

8

4

0

.96

0.9

6

0.

84

-

-

2.76

16

T

rain

ing

for

Lab

Tec

hnic

ians

in M

alar

ia

Mic

rosc

opy

(2-w

eek

trai

ning

) C

entr

e

5,00

0

150

129

20

0.7

5

-

0.65

0.

10

-

1.

50

Su

b-to

tal

2

7.35

1

6.25

1

2.30

2.

73

-

58.

62

17

Stat

e le

vel t

rain

ers

trai

ning

in M

alar

ia

Con

trol

(O

riss

a 8

per

stat

e re

st 4

per

sta

te)

Stat

e

10

,000

2

4

2

4

0

.24

-

0.

24

-

-

0.48

74

18

Stat

e le

vel t

rain

ers

trai

ning

in K

A

elim

inat

ion

(Bih

ar 8

and

rem

aini

ng 2

sta

tes

4)

Stat

e

10

,000

1

6

1

6

0

.16

-

0.

16

-

-

0.32

Sub-

tota

l

0

.40

-

0.

40

-

-

0.80

20

T

rain

ing

in S

ever

e ca

se M

anag

emen

t and

Se

ntin

el s

urve

illan

ce f

or s

elec

ted

hosp

ital

staf

f D

istr

ict

10,0

00

66

16

60

0.6

6

0

.16

0.60

-

-

1.

42

21

Dec

entr

aliz

ed tr

aini

ng in

Mal

aria

cas

e m

anag

emen

t and

soc

ial m

obili

zatio

n fo

r PH

C M

O (

2 ba

tche

s pe

r di

stri

ct)

Dis

tric

t

50

,000

7

5

25

8

6

0

.75

0.2

5

0.

86

-

-

1.86

22

T

rain

ing

for

Lab

Tec

hnic

ians

in u

se o

f K

A

rapi

d di

agno

stic

kits

D

istr

ict

2,

000

9

6

96

8

4

15

0

.19

0.1

9

0.

17

0.03

-

0.58

23

O

rien

tatio

n tr

aini

ng in

Mal

aria

and

KA

ca

se m

anag

emen

t to

priv

ate

sect

or th

roug

h IM

A (

2 se

ssio

ns p

er p

roje

ct d

istr

ict)

per

se

ssio

n D

istr

ict

50,0

00

82

82

57

57

4.1

0

4

.10

2.85

2.

85

-

13.

90

24

Dec

entr

aliz

ed tr

aini

ng in

Mal

aria

cas

e m

anag

emen

t and

soc

ial m

obili

zatio

n fo

r M

PHW

(15

bat

ches

per

dis

tric

t)

Dis

tric

t

20

,000

50

0

250

64

5

25.

00

12.

50

32.

25

-

-

6

9.75

25

D

ecen

tral

ized

trai

ning

in M

alar

ia c

ase

man

agem

ent a

nd s

ocia

l mob

iliza

tion

for

villa

ge b

ased

vol

unte

ers

(ASH

A, A

WW

et

c) (

50 b

atch

es p

er d

istr

ict)

D

istr

ict

15,0

00

1,

500

1,

000

2,15

0

75.

00

50.

00

1

07.5

0

-

-

232

.50

26

D

ecen

tral

ized

trai

ning

in K

A c

ase

man

agem

ent a

nd s

ocia

l mob

iliza

tion

for

PHC

MO

(2

batc

hes

per

dist

rict

) D

istr

ict

50,0

00

32

32

28

1.6

0

1

.60

1.40

-

-

4.

60

27

Dec

entr

aliz

ed tr

aini

ng in

KA

cas

e de

tect

ion

and

soci

al m

obili

zatio

n fo

r M

PHW

(15

ba

tche

s pe

r di

stri

ct)

Dis

tric

t

20

,000

24

0

240

21

0

12.

00

12.

00

10.

50

-

-

3

4.50

28

D

ecen

tral

ized

trai

ning

in K

A c

ase

dete

ctio

n an

d so

cial

mob

iliza

tion

for

villa

ge b

ased

vo

lunt

eers

(A

SHA

, AW

W e

tc)

(50

batc

hes

per

dist

rict

) D

istr

ict

15,0

00

800

80

0

700

4

0.00

4

0.00

3

5.00

-

-

1

15.0

0

29

Sens

itiza

tion

trai

ning

for

Vill

age

Hea

lth

and

Sani

tatio

n C

omm

ittee

s/vi

llage

pa

ncha

yats

/sel

f he

lp g

roup

s co

veri

ng n

ew

serv

ices

pro

vide

d un

der

the

proj

ect a

nd

com

mun

ity o

vers

ight

(ar

ound

600

vill

ages

pe

r di

stri

ct)

Dis

tric

t

1,00

0

24,

600

24

,600

1

7,10

0

16,8

00

2

4.60

2

4.60

1

7.10

16.8

0

-

83.

10

Su

b-to

tal

18

3.90

14

5.40

208

.23

19.6

8

-

5

57.2

1

T

otal

in I

NR

Mill

ion

2

11.6

1

61.6

2

20.9

22

.4

-

616

.6

T

otal

in U

S$ M

illio

n

5

.29

4.0

4

5.

52

0.56

-

1

5.42

T

otal

in U

S$ M

illio

n

75

icro-credit programs. SHGs may afford easy and credible access to the community, and thus have the potential of playing a significant role in strengthening prevention activities at the village level. Size of Study Power analysis indicates that a sample of 4,350 households will be sufficient to detect moderate improvements in net usage and fever treatment at standard levels of statistical significance. 1,050 of these study households (in 35 villages) will be located in blocks that receive the case management treatment of additional MTS and 1,050 will be in comparable and randomly selected control blocks. Villages in additional blocks will be randomly assigned to one of two prevention treatment arms or the prevention control. Each arm of the prevention treatment will involve a sample of 750 households distributed across 30 villages. Data Collection and Analysis The survey data will be collected in two phases. Baseline data collection will occur during September – November 2008, the peak transmission season following the rainy period. Intervention activities will then commence in the January – March period of 2009. Follow-up surveys with the same households will be fielded exactly 12 months after the baseline in September – November 2009, and then again in 2010. The follow-up survey will be partly based on the baseline survey instrument but will also record detailed information on the household responses to the experimental intervention in terms of adoption and behavior change. The data will be collected using a professional survey team and will be entered in India with sufficient safeguards being taken to ensure accuracy and respondent privacy. Supplementary information will be provided by the HMIS. As soon as preliminary results are validated they will be shared with the NVBDCP directorate.

76

Annex 5: Project Costs Project costs are presented in two tables. The first shows the total project costs including the three components and their subcomponents, as well as an unallocated amount. Because of joint costs across project subcomponents, it is not always possible to break down costs across different subcomponents within a component. This is why some subcomponents have small values. The unallocated amount has been retained in the project costs as a contingency to allow more rapid scale up of the distribution of commodities for malaria control and kala azar elimination, such as LLINs. It is also a contingency to allow the project to support costs of NGO partnerships and efforts to improve private practice, in case the proposed GFATM funding is not available and fiduciary arrangements acceptable to the Association can be agreed for such expenditures. Components/Sub-Components

Costs

(US$ Million) Component 1: Improving Access to and Use of Services for Control of Malaria

119.5

Sub-Component 1.a.: Improving Malaria Case Management 45.0

Sub-Component 1.b.: Strengthening Malaria Surveillance 5.9

Sub-Component 1.c.: Effective Vector Control 68.6

Component 2: Improving Access to and Use of Services for Kala Azar Elimination

41.9

Sub-Component 2.a.: Improving Kala Azar Case Management 40.0 Sub-Component 2.b.: Strengthening Kala Azar Surveillance 1.5

Sub-Component 2.c.: Effective Vector Control 0.4

Component 3: Policy and Strategy Development, Capacity Building and Monitoring and Evaluation

52.1

Sub-Component 3.a.: Policy and Strategy Development 23.1

Sub-Component 3.b.: Capacity Building and Program Management 24.2

Sub-Component 3.c.: Monitoring and Evaluation 4.8

Component 4: Improving Polio Vaccine Availability 271

Total Baseline Project Cost 484.5

Unallocated Amount 33 36.5

Total Project Cost 521.0

33 The refund of the Project Preparation Facility Advance of US$ 1 million will be financed from this unallocated amount

77

The second table (below) presents the agreed cost estimates for standardized costs of contractual staff, mobility, and training at state and district level. These costs will be reviewed jointly at the time of project effectiveness and may be revised if needed. They will be revisited again at the time of the early implementation review after 18 months of project implementation.

A. Standard Cost for a Project District Unit

Cost/INR No. of Units

Total Cost INR Total Cost US$

Contractual Staff* 123000 12 1476000 36900 Mobility 15000 12 180000 4500 Training (Per annum) 1,785,000 44625 Total 3441000 86025

B. Standard Cost for a Project State Unit

Cost/INR No. of Units

Total Cost INR Total Cost US$

Contractual Staff* 212500 12 2550000 63750 Mobility 50000 12 600000 15000 Training (Per annum) 60000 1500 Total 3210000 80250 *As approved by EFC

Estimated Resource Requirements for Polio Eradication 2008-2011 (in US$ million): Budget line 2008 2009 201034 2011 Total Vaccine 138 117 58 60 373Operations (GOI) 160 100 65 65 390Operations (WHO) 7 6 6 6 25Social Mobilization (UNICEF)

13 7 5 5 30

Surveillance Network including laboratories (WHO)

21 22 23 23 89

Total 339 252 157 159 907

34 This is based on the ‘best case scenario’ i.e. that the last case of type 1 polio occurs in 2008 and the last case of type 3 polio occurs in 2009.

78

While there may also be additional financing available from other external sources, the financing gap is currently expected to be to the order of US$230 – 270 million. However, as explained earlier in Annex 1B, the total vaccine requirements cannot be precisely predicted, due to the nature of the epidemiology of the virus.

79

Annex 6: Implementation Arrangements

Health sector projects in India have often suffered from weak implementation. Delays in creating staff positions and making appointments, in procuring goods and services and in releasing funds remain persistent. Procurement of services is especially weak and results in most surveys and studies getting delayed to a point that their results have often limited value for the project under implementation. And the regularly planned reviews do not take place. At the state level, often funds allotted to address specific issues such as mobility for the supervisors, do not get reflected in the state budget and used. These and related issues often result in unsatisfactory implementation and eventually to project development objectives being not or only partially met. A. The Vector Borne Disease Component

Implementation arrangements for the NVBDCP have been designed taking into account the above systemic weaknesses and findings of the institutional assessment carried out by IDA during the project preparation. The project will adopt learning by doing approach by providing inputs to a limited number of high malaria and kala azar burden districts during the first two years. A comprehensive review will be undertaken before further scale-up. Minimal inputs will be provided to other high endemic districts to sustain the current level of services. The project will require implementation actions at the central, state, district and sub-district levels. Existing institutional arrangements at all these levels, with appropriate strengthening as required, will be used. The proposed implementation arrangements are briefly described below: Central-level: The overall implementation responsibility of the project will rest with the Ministry of Health and Family Welfare (MOHFW), Government of India (GOI) under the framework of the National Rural Health Mission (NRHM). The Directorate of National Vector Borne Disease Control Program (NVBDCP), under the Directorate General of Health Services, MOHFW, GOI, is the national level government unit dedicated to the program. NVBDCP consists of seven program divisions each addressing control of a disease, six of these headed by a Joint Director each and the seventh by a Deputy Director, in charge of kala azar elimination. There are similarly four support service divisions, i.e., IEC/BCC, procurement, training and administration. Joint Director Malaria, heading the Malaria Division has two Deputy Directors, an Assistant Director, a Senior Research Officer and several office staff supporting her/him. The NVBDC Director, a Deputy Director-General level officer, will coordinate and supervise the implementation in the NVBDCP. NVBDCP is responsible for formulating policies and guidelines, monitoring, and carrying out evaluations from time to time. NVBDCP will provide the technical leadership and support for day to day operational decisions for the project. It will constitute a “Project Management Group” responsible for the project and headed by the Director. The Project Management Group will have a focal point for each of the high burden states who will undertake state visits at least once every quarter and share their observations in the

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quarterly project review meetings. The project will provide consultant support to the management group. The National Institute of Malaria Research (NIMR) is an institution under the Indian Council of Medical Research (ICMR), part of the Department of Health Research in the Ministry of Health and Family Welfare. NIMR will be responsible for operational research and will also support project initiatives to improve therapeutic efficacy monitoring, promote quality assurance and improve monitoring of service delivery through periodic household surveys. NIMR has a number of field stations located in different parts of India. Project Steering Committee: A steering committee is being proposed to ensure that there is regular review, discussion and action on project implementation involving both the central and the state levels. In several projects, often actions required at the central level get delayed, e.g., important procurement, and the states watch helplessly while implementation suffers. Similarly often the states do not have clarity on some project activities and neglect their implementation. The Project Steering Committee will be chaired by the Joint Secretary, MOHFW, and have the following members: Director; Joint Director, malaria and Deputy Director, kala azar from the NVBDCP; Representative of Mission Director, NRHM, Regional Directors for the concerned states; and Joint Directors, NVBDCP from the five states of Andhra Pradesh, Chhattisgarh, Jharkhand, Madhya Pradesh and Orissa. WHO, GFATM and IDA will participate in the meetings as observers. The Steering Committee will meet quarterly to discuss specific agenda to be circulated two weeks in advance; similarly minutes of the meetings will be prepared and circulated within two weeks after the meeting. The Steering Committee will help keeping project implementation on track by reviewing and ensuring that all key actions, at central and state levels, get taken and any constraints that impede progress are addressed. It will also provide policy support and administrative approvals for state plans and for key program decisions. The Joint Secretary will have overall coordination responsibility in the MOHFW assisted by a Director level officer and the Joint Director, NVBDCP responsible for the project will be the member Secretary of the Project Steering Committee. NVBDCP is being strengthened for implementation of this project by (i) GFTAM providing eight senior consultants and support staff for malaria control; WHO providing six consultants to address kala azar; and the project itself supporting ten consultants at the central level and over 100 staff/consultants in procurement, financial management, environment, training, supervision, etc. at the state, district and sub-district levels. These consultants will be in position in time for startup in the initial project districts and for other districts at the time of review of the districts readiness criteria. NVBDCP will also contract with national NGOs and other technical agencies to strengthen capacities for supporting decentralized programming, community monitoring, and other implementation needs. Regional-level: The MOHFW’s 17 Regional Offices for Health and Family Welfare, located in 17 States, will also play a role in project implementation. These regional offices support the NVBDCP. They conduct entomological studies in collaboration with the States, drug resistance studies, cross-checking of blood slides for quality control, capacity building at the state level, monitoring and supervision. The National Institute for Malaria

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Research under the Indian Council for Medical Research has field stations in 9 States and supports the malaria control program through operational and applied field studies. State-level: The States are responsible for implementing the program’s preventive and curative services, and monitoring in accordance with central guidelines. Every State has a Vector Borne Disease Control Unit under its Department of Health and Family Welfare. The state unit is headed by the State Program Officer, mostly a Joint Director, who is responsible for day-to-day management as well as technical aspects of the program. She/he will be accountable for the preparation and implementation of state project implementation plan. The state PIP will be based on district implementation plans developed following the guidelines provided by the NVBDCP. The focus will be on improving outcomes in high burden districts for malaria and kala azar ensuring effective coordination with the NRHM. The States have established State Vector Borne Disease Control Societies, which are now in the process of being integrated with similar entities established for other Centrally Sponsored Schemes into a single state-level Health and Family Welfare Society under the NRHM. The State Integrated Health Society will have the overall coordination responsibility for the implementation of the project plans approved by the central Project Steering Committee. Its main role will remain to channel funds from the GOI to the States (and onwards to districts) for the financing of the programs (VBDCP and other CSSs). These societies will also play a role in district planning and monitoring of program activities within districts. State Project Coordination Committee: To ensure effective project coordination and review, a State Project Coordination Committee for the five high disease burden states of Bihar, Chhattisgarh, Jharkhand, Orissa, and Madhya Pradesh is proposed to meet once a quarter. This committee will be chaired by the Chief Secretary or a senior officer designated by him and will have the following membership: Health Secretary; Finance Secretary; Director of Health Services; State Mission Director, NRHM; and Regional Director with the State Joint Director/State Program Officer acting as the Member Secretary. This high-level Committee will review implementation progress and address constraints through summary orders. Agenda will be circulated two weeks in advance and minutes of the meeting within two weeks after the meeting. District and Block Level: At the district level, the District Integrated Health and Family Welfare Society chaired by the District Collector will be responsible for the overall coordination. It will approve and monitor the implementation of the district action plans prepared by District Vector Borne Disease (VBD) Officer. At the district level, District Malaria Offices have been established in most places headed by the District Malaria Officer who will be designated as nodal officer for vector borne disease control. This is the key unit for the planning and monitoring of the program. For high malaria and kala azar burden districts, the project will provide additional consultant support to the district VBD Officer. Both of them will be provided management training covering the core program principles, resource mapping, implementation arrangements for improved service delivery in public and private sectors, quality assurance, supply chain

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management, monitoring and evaluation, contracting non-government sector for project activities, social mobilization, financial reporting and procurement. Actual service delivery and passive and active case detection will be carried out by staff at the district hospitals, block and sector Primary Health Centers (PHC) and sub centers of the States’ Health and Family Welfare Department. Village-level: Services will be provided at the village/community level by “ASHA” (Accredited Social Health Activist – a village health worker) and other community level volunteers according to local conditions. A key strategy of the project is to increase access to new diagnostic, treatment and control technologies at the community level. These will be supported by training, increased supervision, behavior change activities and involvement of village health committees. District Readiness for Implementation A standard protocol for processes and certification to assure district level readiness for project implementation has been agreed with NVBDCP. This protocol will be applied in all the Phase 1 districts and will be reviewed at the time of the early implementation review for possible revision. Information will be available from project supervision activities including the regular HMIS, IDA’s supervision missions, and the sample district reviews to provide regular feedback on district activities. In each project district, the following will be put in place to assure readiness for implementation:

(a) A full-time VBD officer or consultant posted by the state and actions to recruit contractual staff at district level and below following project norms initiated.

(b) The district VBD officer/consultant received orientation training in district planning for VBD control.

(c) A draft District Implementation Plan prepared including the following:

(i) Case management: identification of villages for providing case management (RDTs, ACT) by ASHA.

(ii) Integrated vector management: listing of villages for vector control activities (IRS or LLIN).

(iii) Logistics: storage and distribution arrangements for medicines, RDKs, insecticides, and LLINs detailed.

(iv) Training: prepare plan for training in case management and social mobilization to health staff and community volunteers, and sensitization of Cobs.

Once districts have completed these steps, each district will be visited by a review team including NVBDCP staff or consultants and state level staff or consultants to review the draft plan and readiness with the VBD project team and the District Medical Officer. The

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plan will also be presented to the District Magistrate. Upon satisfactory completion of the readiness processes, the review team can certify the district ready for implementation. At the time of the early implementation review, approximately 18 months after effectiveness, Phase 1 districts will be reviewed for implementation status. A scorecard will be used for this purpose. Attachment 1 shows a draft scorecard being developed by NVBDCP for this purpose. This will be revised and agreed with IDA before the early implementation review. Procurement: The detailed procurement arrangements are described in Annexure 8. Institutional Set-up for Quality Assurance In India, Drugs and Cosmetics Act, 1940 regulates the drugs and pharmaceuticals. Central Drugs Standard Control Organization (CDSCO) is responsible for imports and approval/ban of drugs apart from acting as Central License Approving Authority (CLAA). Many of the Indian states have very weak Drug Regulatory Authorities (Drays) and there is hardly any control over the movement of drugs from places with weak controls to other places except random checking by drawing samples available in the market. In most of the states, DRA are understaffed and no established systems are present. Drug Controller of a state is responsible for ensuring quality of drugs manufactured or sold in the state, whether in the government sector or private sector. She/he is authorized to grant licenses for manufacture, storage by medical stores including government stores, and for sale of drugs. She/he also issues GMP certificate following the procedures laid out in the Revised Schedule M of Drugs and Cosmetics Act. However, the WHO GMP certificate is issued only after undertaking a joint inspection with the representative of the Drug Controller General of India. The DRA in most states is generally small and inadequately staffed, the exceptions being Maharashtra and MP which have comparatively larger organizations. The drug inspectors are field officers of the Drug Controller’s organization and generally one or more are posted in a district, depending on the workload. The lack of capacity of DRA is a major concern particularly with GOI making of GMP certification using revised Schedule M mandatory since July 2006. In some states, powers of the Drug Controller have been delegated to district authorities. For example, in some states, the Drug Inspectors report to the district authorities and work under their control and the power of granting drug license has been delegated to the districts and usually the Chief Medical Officer of Health exercises the powers. There are testing labs under the Drug Controller’s Organization but they do not have adequate capacity. Efforts are being made to strengthen capacities of the drugs testing laboratories under the IDA supported Food and Drugs Capacity Building Project (Credit No. 37770-IN). The quality of Diagnostic Kits on the other hand is governed by ISO standards (which is a process standard for the manufacturing facilities) and quality assurance test results

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concerning quantitative assay, chemical analysis, sterility, progeny content uniformity, microbial limit etc. These are decided on case to case basis. The Central Insecticide Board (CIB) under the Ministry of Agriculture is responsible for ensuring the safety of various insecticides and allied products such as LLIN. CIB also issues license for use of such products, which are imported in the country. In context of quality, there are two major challenges. Firstly, the difference between the regulatory standards between those set out by the Government of India and international best practices like WHO GMP. Secondly, there is a scope for improving capacity for monitoring the compliance of the quality standards. An IDA commissioned study compared the WHO GMP with that of Indian GMP standards under the revised schedule M and listed the key differences. The MOHFW has prepared a technical note to guide the drug inspectors in addressing these deficiencies during the implementation of revised Schedule M. MOHFW is organizing series of workshops to familiarize the drug inspectors identified by states in the use of these additional technical notes. For the supplies from other countries with weaker regulatory regimes, the quality of products also poses considerable risk. MOHFW is working on strengthening the revised Schedule M through introduction of technical notes and training of drug inspectors. Until such time this process is completed to the satisfaction of IDA, WHO GMP shall only be used for all procurement of pharmaceuticals and medical supplies. Pre-dispatch and post-dispatch inspections shall be conducted to ensure the adherence to agreed specifications and quality standards. An independent inspection agency (selected by MOHFW or by procurement agent through competitive selection procedure) shall monitor the quality of pharmaceuticals by picking up random samples during the project period and getting these tested at accredited labs. In addition, five government-owned units (such as ICMR) will also monitor the quality of drugs and insecticides procured under the project. IDA has also hired an expert on pharmaceutical quality to deal with quality related issues. Quality assurance of RDTs is of critical importance. NVBDCP has prepared draft guidelines based on WHO recommendations. These will now be reviewed by a WHO consultant, who will also work with NVBDCP and NIMR to set up a plan for implementation including standard operating procedures for collection of samples from stores and end-users, and laboratory evaluation at Norm’s facilities. Supply Management and Logistics Pre-dispatch inspection of goods will be carried out by the procurement agent. The MOHFW will develop a system for post dispatch inspection using accredited laboratories for sample testing. When issuing supplies, it will be made sure that batch samples are kept at the warehouse until expiry for control purposes. A professional agency will develop and implement an inventory management system including development of a system for random and periodic stock checks.

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The implementing agencies will ensure that physical inventory check of all products is carried out at least semi-annually and will make sure that, as a minimum, the following information is kept in the stock records: product name, beginning stock balance, receipts, issues, losses and adjustments, ending stock balance, and transaction reference. It will also be ensured that adequate and appropriate storage capacity with adequate storage equipment (e.g., pallet racks, trolleys, forklifts) is available for the commodities and a warehouse operations manual adequately describing procedures and responsibilities at the warehouse exists, and that the manual is being followed. Sufficient and adequately trained staff will be made available to operate the warehouse and adequate security measures will be put in place to prevent theft. It will be ensured that storage conditions (e.g., temperature, humidity, cleanliness) are appropriate for the commodities and the systems to deal with expired products are in place. Proper transportation arrangements will be made for distribution of the commodities to facility level. At facility level, it will be ensured that stock and distribution registers are maintained and proper storage is available. Inputs from Non-IDA Sources To achieve project development objectives, MOHFW will ensure the quality, quantity and timeliness in supply of the goods/services financed from non-IDA sources. Financial Management: In the Vector Borne Disease Component (US$250million) about 85% is expected to be incurred at the Central level by the Directorate primarily on procurement of drugs, long lasting bed nets and M&E. The NVBDCP will be responsible for administering GOI’s financial assistance to the states for this project. Based on the joint action plan following the DIR, the decentralized expenditures to be financed under the project are limited to contractual staff salaries and mobility cost of various staff and training cost. The financial management arrangements under the previous project were found to be weak in certain states and district. Issues primarily related to lack of timely financial reporting, inadequate internal control, delays in submission of audit reports and inadequate monitoring by the GOI. To address these issues, MOHFW is integrating all disease control programs under NRHM into one entity at the state and district levels. The detailed financial management arrangements are described in Annex 7. Monitoring and Evaluation: The NVBDCP Directorate will have the overall responsibility for monitoring and evaluation. The following indicators will be used to measure the project success:

• Percentage of fever cases in project districts receiving a malaria test result no later

than the day after the first contact.

• Percentage of individuals in project areas belonging to eligible LLIN target population who slept under an LLIN during the previous night.

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� At least 50% of sampled blocks which at baseline have not achieved the elimination goal of less than one kala azar case per 10,000 persons, will achieve the elimination goal by endline Percentage of kala azar endemic districts that achieve the elimination goal of less than one kala azar case per 10, 000 persons at sub-district level.

For effective implementation of the M&E framework, specific inputs - human resources and training - will be provided to build capabilities in the districts to undertake M&E in accordance with the framework. The M&E tools, including a set of standardized forms and records to track the stocks, storage, distribution, and use of commodities, will be developed by NVBDCP in partnership with the states, and field-tested, and standardized with consultant support. There will be monthly reviews at districts, quarterly reviews at state, and semi-annual reviews at national level; these reviews will be more frequent during the first year, say, monthly at the state and quarterly at the national level. These reviews will be supplemented by systematic visits undertaken by NVBDCP and Regional Directors of Health Services to the states and districts; a mid-term and an end-line expert review; and two household and health facility surveys, one at mid-point and the other at project end. Monitoring by the community will be an important activity which is consistent with the objectives of NRHM and more realistic to provide for than in the past due to the availability of new technologies such as rapid diagnostic kits and GIS.

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Attachment - I

Draft District Implementation Scorecard Input Status Yes: 1 No:0

District VBD officer 1 1 Regular Program Staff in position All identified microscopy centers have lab technicians 1 District VBD consultant 1 2 Additional Staff in position Malaria Technical Supervisor 1

3 Supplies No stockout of ACT at identified facilities 1 4 Surveillance Sentinel sites identified 1

Program managers 1 5

Training in Program management provided Malaria Technical Supervisor 1

6 Training in management of Severe Malaria completed

District and Sub District Hospital staff 1

General Duty Medical officers 1 Lab Technicians 1 Supervisors 1 Multipurpose workers 1

7

Cascade training in malaria Case Management, passive surveillance, vector control and social mobilization completed

ASHAs 1 Maximum Score 14

Output Status Yes: 2/3 No:0 Lists phasing of case management services 2 Stratifies areas for IRS/ITN 2 Maps Vulnerable communities 2 Indicates specific actions to improve services for VC 2

1

District Plans prepared

Lists popular private providers for accreditation 2 Identified public faculties providing 24 hrs. services as per protocol 2

2

Case Management

At least 50% of identified popular providers accredited 3 Sentinel Site Type I functional 2 3

Surveillance

Sentinel Site Type II functional 3 Maximum Score 20

Impact Status Yes:4 No:0 1 Surveillance At least one suspected outbreak is investigated 4

At least 50% of fever cases reporting at identified public/accredited private facilities are tested for malaria within 24 hours 4

2

Case Management

At least 75% of persons found positive for Pf (except pregnant women in their first trimester) by identified facilities receive adequate treatment 4

3 Vector Control At least 25% of households targeted for IRS are completely sprayed in each planned spray round 4

Maximum Score 16 TOTAL SCORE 50

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B. The Polio Component The proposed activities will be implemented by the existing public health structures in the states of India. The Ministry of Health and Family Welfare (MOHFW) along with the state governments and their directorates of health have the overall responsibility for ensuring that polio eradication activities are well executed. NPSP has the responsibility for technical and management support, monitoring, training of field staff, external verification of vaccination coverage, as well as the overall quality of the laboratory network. UNICEF has the responsibility for vaccine procurement, supply and quality assurance as well as the social mobilization activities for NIDs and SNIDs. The IEAG, a group of national and international stakeholders from the government, the private sector, academic institutions and international organizations including WHO, meets regularly to assess the situation and provide technical direction for the project. Program details are in annex 1b.

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Annex 7: Financial Management Assessment

The project consisting of Vector Borne Disease Control and Polio Vaccine components has adequate financial management arrangements to account for and report on project expenditures. A. Vector Borne Disease Control Component (about US$250 M) Background The Malaria and Kala Azar component of the project is a follow on to the Enhanced Malaria Control Project closed in December 2005. NVBDCP will focus on malaria control activities in 93 Districts from 8 States and on kala azar elimination in 46 districts in 3 States. In phase I, 50 districts from 5 States (Orissa, Chhattisgarh, Jharkhand, Madhya Pradesh and Andhra Pradesh) under Malaria and 16 Districts under Kala azar in the state of Bihar will be covered. The component will be extended to Phase II after a period of 18 months based on early implementation progress review by IDA. This component of the project (which is a subset of the larger NVBDC program of GOI) is estimated to cost around US$250 million, which will be financed 100% by IDA, with GOI financing other activities under the program. About 85% of the project cost will be incurred at the Central level by the NVBDCP Directorate primarily on procurement of drugs, long lasting bed nets, central level training, BCC, M&E, contractual staff and operating costs activities. The expenditure to be financed under the project at the decentralized level i.e. states and districts will be limited to contractual staff, mobility cost of various staff and training cost which is estimated to be about US$37 million. Expenditures on other activities at the state/district level such as micro slides and reagents, IEC, spray wages and office costs are included under the NVBDC program and will be financed by GOI. Implementing Entities The Malaria and Kala Azar component of the project will be implemented by the Directorate, NVBDCP at the centre, by the State and District Health societies at the states and districts respectively. In addition limited activities relation of surveillance, studies and training will be executed by research institutions within the MOHFW. While the Directorate, NVBDCP is responsible for overall management of the project and will have a financial management cell at the centre to monitor the financial management, the finance staff of National Rural Health Mission (NRHM) supplemented with project specific finance staff at the states and districts will be responsible for the financial management of NVBDCP at their respective levels. Financial Management at the Central level Budgets and Funds Flows: At GOI level, the project’s funding requirements are provided within the budget of the MOHFW. NVBDCP has a separate budget head (minor head).

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At the national level, the budget is operated by the Directorate, NVBDCP and adequate provision has been made in the budget for the year 2008-09. Funds for procurement by the procurement agent will be made available by the Directorate by drawing on the non-plan budget and based on actual utilization/submission of settlement documents, the expenditure is charged to the plan budget. Need based funds will be advanced to the research institutions for specific activities for which settlement reports will be submitted to the Directorate. Accounting, Internal control and Financial Reporting: The accounting for expenditures at the central level is done by the Pay and Accounts Office (PAO) headed by the Chief Controller of Accounts within the MOHFW. The NVBDC Directorate maintain cash book and other subsidiary records (including advances to and settlements by the procurement agent etc), the balances in which are periodically reconciled with the PAO. Grants provided to States against approved actions plans are recorded as expenditure in the books of account of MOHFW. All sanctions for expenditures/ release of funds are required to be approved35 by the Financial Advisor in MOHFW. These financial records will form the basis of preparation of the Interim and Annual Financial reports for submission to IDA, the formats of which have been agreed to. Until such time as the procurement and supply management capacities of the implementing agencies are developed to the satisfaction of IDA, all ICB/LIB and NCB procurement above US$ 100,000 will be carried out by a qualified procurement agent or through a UN agency hired to do so on turn-key basis (viz. from receipt of the indent till the delivery of the goods to consignees). The procurement of services at the central level will also be handled by the procurement agent till the implementing agencies develop their in-house capacity. However in procurement of services, the role of the procurement agent will be limited up to the contract award recommendation stage, while the contract shall be signed and managed by MOHFW. Finance Staffing. The existing accounts wing in the directorate which is headed by a senior accounts officer will be strengthened by contracting of two finance consultants, of which one is already in position and the second will be contracted within three months of effectiveness. The finance consultants will have responsibility for liaison with the procurement agent (fund transfer, collection of expenditure reports and settlement of advances etc) and oversight on the financial management arrangements at the state and districts together with the financial management group established under National Rural Health Mission (NRHM). Audit Arrangements: The annual audited project financial statements for this component of the project will include (a) the actual expenditure at the Central level; and (b) the transfers to states for decentralized activities. The audit will be conducted by the Comptroller and Auditor General of India (Bandag) who is constitutionally independent. IDA and the Ministry of Finance are in discussion with the Bandag to agree on a Standard Terms of Reference which will provide a framework for audit of all IDA financed projects. A project specific TOR will be agreed with the Bandag within this

35 A project specific delegation of powers has been proposed by the Directorate up to Rs 50 lacs, which may be approved after project effectiveness.

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overall framework after the negotiations, as the Bandag requires the finalized legal documents to provide its concurrence. (Project Specific TOR to be consented to by Bandag).

Implementing Agency Audit Auditors Timeline The Directorate, NVBDCP ‘Project Financial

Statements’ for the Malaria and Kala Azar component of the project including the actual expenditure at the central level and transfers to states

Comptroller and Auditor General of India

30 September

Financial Management Arrangements at the State/ District level: The key lessons that emerged from the earlier project are: the financial management arrangements in some states and districts were not adequate, with the weaknesses mainly being (a) lack of familiarity with double entry accounting and maintenance of ledgers by Government staff resulting in delays in SOE and preparation of financial statements; (b) inadequate internal and operational controls; and (c) consequent delays in submission of audit reports. The strengthened audit arrangements36 in the last two years of the project (2004-05 and 2005-06) also resulted in identification of internal control weaknesses at state and district levels in the states of Orissa and Chhattisgarh. The Detailed Implementation Review (DIR) carried out by IDA has also identified systemic weaknesses in decentralized procurement, based on which the Joint Action Plan agreed with GOI limits financing of expenditures at the decentralized level to contractual staff costs and operating expenditures. Accordingly the activities, at the decentralized level, to be financed under the project are limited to contractual staff, mobility costs of various staff and training cost. These are a subset of a larger number of activities and expenditures to be incurred at the states/ districts under the program. Integration of financial management arrangements under National Rural Health Mission: A detailed financial management assessment carried out covering a sample of five states in January 2007 suggested several measures for improving financial management in the NVBDCP. Subsequently in August 2007, the MOHFW has decided ‘in principle’ to integrate various disease control programs including the financial management arrangements with the NRHM. Thus, the financial management capacity of NRHM will have a major bearing on the successful implementation of financial procedures for NVBDCP. While there will be a separate financial management cell in the NVBDCP Directorate at the centre, the financial management arrangements for NVBDCP at the state, districts and sub district levels are proposed to be integrated with NRHM. This will include funds flow, administrative and financial delegations/ rules, accounting and internal control, finance staffing, financial reporting and audit assurance mechanisms. The MOHFW has constituted a committee under the Chief Controller of

36 Degree of independence in appointment of auditors with GOI sending a short list obtained from CandAG, appointment of one firm for audit of State and District Societies and agreeing on TOR for audit.

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Accounts (CCA) of MOHFW to guide the development of a common financial management manual by Financial Management Group (FMG) applicable for all programs funded by MOHFW, while retaining the needs, especially financial reporting requirements, of individual programs. As a first step, the MOHFW has already issued (a) Guidelines on budgets, annual plans funds flow, and banking arrangements; and (b) Financial guidelines and framework for delegation of administrative and financial powers. From the NVBDCP perspective, this will essentially mean incorporating the budget formats, chart of accounts and financial reporting formats of NVBDCP in the NRHM finance manual. In addition the FMG is developing procedures to enhance the audit assurance by strengthening the process of selection of auditors. These are expected to be completed by September 30, 2008. As a part of the integration of the disease control program with NRHM, project finance staff, operating under the overall umbrella of NRHM at the state as well as district levels will be responsible for funds flow, accounting and reporting the expenditure for all disease control programs including NVBDCP. The Books of Accounts at the states and districts will be maintained as per the NRHM financial guidelines. Standard Books of Accounts will be maintained on a double entry basis in the state and district societies which will include cash and bank book, journal, fixed assets register and advances ledger. Expenses will be recorded on a cash basis and will follow, broadly, the project activities. Internal Procedures applicable to the decentralized activities (about 10% of the project cost) to be followed by NVBDC Directorate and arrangement between MOHFW and the States/ Districts: The Directorate will follow the normal process of releasing funds as cash grants to states against approved Annual Action Plans (Asps). The AAP for each state is approved based on the actual pace of implementation and incorporates the district plans. The States in turn will transfer funds to districts for implementation of project specific activities. The annual budget allocated to each state is released in two installments during the first and third quarters of each fiscal year through the electronic transfer of funds. The state unit will transfer funds for activities to be implemented by the districts. The funds will be transferred to the designated bank account in the state as well as districts, which will be maintained as a sub account for NRHM bank account, as per the NRHM guidelines. The districts and states will maintain program specific books of account including activity wise ledger accounts as specified in the NRHM financial management manual and submit quarterly financial reports to the FMG in MOHFW and the Directorate. The annual audit report of all programs under NRHM (consolidated for the State and Districts) will be carried out as per the TOR specified in NRHM manual/ guidelines and will be submitted to MOHFW within 6 months of the close of the financial year. Financing of Selected Decentralized Activities and Fiduciary Assurance for IDA for Related Expenditures: IDA will finance the selected decentralized activities for states and districts (contractual staff, mobility costs of various staff and training cost) based on standard costs for such activities agreed between MOHFW and IDA. The standard costs will be derived from a detailed list of the planned expenditures by district and state, which will be reviewed by IDA for reasonableness. Considering that the activities proposed to be financed by IDA under the project are (a) a small subset of relatively

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simple and non technical activities to be carried out at the State and District level which are covered by MOU between the central and state governments; (b) associated with fewer financial transactions and can easily be coasted with reasonable assurance; (c) carry inherently lower risk activities and transactions; (d) limited to selected states/ districts within the larger program of MOHFW; and (e) necessary for effective implementation of overall district program activities (i.e., there is a low risk that the financed activities will not take place and the expenditures is not incurred); the following approach of integrated implementation and fiduciary review of such activities including focusing on intermediate outputs will be used to obtain necessary fiduciary assurance that the funds are used for intended purposes.

(a) MOHFW being responsible for oversight of the project, will provide IDA with quarterly performance reports for project activities in the states and districts as per agreed timeframe.

(b) The Directorate, within 120 days of the end of the year will provide IDA with annual state and district-wise physical and financial reports which will enable comparison of the transfers (from the national government to the states and districts) with the actual expenditures reported by the districts.

(c) An independent monitoring consultant will be appointed by MOHFW to conduct implementation and fiduciary review of the selected activities in a sample of states/ districts providing feedback on whether planned staff were appointed through the appropriate process, are in position, have requisite contracts, are paid regularly in accordance with the contracts, and whether they are effectively performing their duties, and whether the training activities were being implemented as per program norms. The TOR for such integrated review will be agreed with MOHFW during negotiations.

(d) IDA will supplement this by supervision including review of the annual audited project financial statements (which will include the funds transferred by MOHFW to the States, along with other central level project expenditures), field visits and desk reviews of MIS information on staffing and training, review of standard costs and units as well as training programs; and a review of the sample of audit reports which will be received by the Directorate.

(e) Financial management capacity building activities and enhancements for the GOI program.

(f) Annual Lot Quality Assurance37 Sample Surveys confirming the availability of trained village level providers and thereby confirming that the training took place and is benefiting the implementation of the program). These surveys will include the same sample districts as being reviewed by the above-noted independent consultants.

(g) Bi-annual Technical Program reviews to the satisfaction of the Association. During early implementation review, based on the results of the integrated implementation and fiduciary review and a comparison of the actual costs with the

37 Lot quality assurance is a well known methodology for sampling activities to obtain a reliable and valid estimate for larger areas.

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standard cost, this method of financing, the standards costs and assurance mechanism will be assessed and redesigned, if necessary. This approach is considered more appropriate as it integrates implementation and fiduciary review and given the relatively lower risk associated with the activities to be financed at the decentralized level and limited financial exposure per district. In addition the financial exposure on decentralized expenditure in Phase I of the project is only estimated to be US$12 million. There will, however, be a residual risk given (a) the decentralized nature of operations; (b) delayed implementation in certain districts leading to standard costs being higher than actual expenditure; and (c) internal control weakness in some of the districts. The sample of coverage in the integrated review will be reviewed based on the findings of the review in the first one year. The details of standard costs- units, unit cost and basis of determination are given in Annex V- (Project Cost) of the PAD. These will be reviewed at project effectiveness for this component and may be revised for phase I, if considered necessary. Financial Reporting and Disbursement Arrangements: The project will submit quarterly interim unaudited financial reports (IUFR) in the agreed formats which will reflect the central level expenditures (including those incurred by the procurement agent and research institutions); the grants transferred to states for decentralized project activities and the standard cost of the selected decentralized activities to be financed by IDA38. The IUFR will be submitted within 45 days of the end of each quarter. Reimbursement by IDA will be made annually using report-based disbursement, as for the project as a whole. The IUFR at the end of the financial year will be the basis for reimbursing MOHFW; reimbursement will be limited to the central level expenditure and the agreed standard costs for decentralized activities at the state and district levels to be financed by IDA. A district will be eligible for reimbursement of such standard costs in 3 months39 after being certified as ready (by the Directorate) for implementation of the selected activities financed by IDA. The central level expenditures and transfers to states reported in the Infers at the end of the financial year will be validated by annual audited financial statements to be received within 6 months of the closure of the financial year. Any variance between the amount reported in the IUFR (central level) and the audited expenditure (central level) will be adjusted (recovered or reimbursed) from the next disbursement to the GOI. The chart below illustrates the disbursement and reporting arrangement between IDA and GOI/ MOHFW (part A) and reporting arrangement between MOHFW and States/ Districts and normal funds flow (part B) and the arrangements within MOHFW (Part C for central expenditures).

38 The standard cost of the selected decentralized activities to be financed by the Bank will be calculated on annual basis and presented in the agreed format of IUFR for the last quarter of the financial year. 39 It is estimated that it takes about 3 months to recruit staff and initiate necessary project related activities.

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BANK

MOHFW

Annual Disbursement based on IUFR covering Central Expenditure and Transfers to States

for decentralized expenditures on the basis of Standard Costs

Procurement Agency

GOI entities NIMR, RMRI and other Institutions

About 85% of Project cost

ReleasesBy

MOHFW

Periodicfinancial reports

ReleasesBy

MOHFW

About 15% of Project cost

Integrated State Health SocietyNRHM Finance

consultant

Integrated District Health SocietyNRHM Finance

consultant

Integ

rated Im

plem

entatio

n an

d

Fid

uciary review

of sam

ple d

istricts

MOHFW release for approved state plans

Periodic financial Reports

Release for approved

District plans

Periodic financial Reports

India – VBDCP - Funds flow and Reporting

PART A

Part B: Arrangement between MOHFW and States/Districts

Part C: Arrangementswithin MOHFW

Periodicfinancial reports

IUFR and Annual Audits Reports

FM Capacity Building and Support: In parallel and in support of enhancing the overall program control environment, IDA is working with the MOHFW to further build capacity of the states/ districts to improve financial management. These activities include developing an integrated financial management manual under the National Rural Health Mission (NRHM) (which includes the NVBDCP activities), training and capacity building and enhanced audit assurance mechanism. The enhanced audit assurance includes agreeing on specific selection criteria and the contracting process for auditors of the state and district program implementing entities. All of these activities are directed at improving the country systems used by MOHFW for receiving assurance over the use of its own funds. These, and other, actions by the government to promote and receive enhanced assurance are additional mitigating actions that support IDA’s integrated and holistic approach to receiving assurance over the limited decentralized project expenditures. Oversight by MOHFW: MOHFW will provide an oversight to the project and will also appoint independent consultants, based on TOR approved by IDA to carry out review of the selected decentralized activities covering a sample of districts. MOHFW will obtain the actual expenditure reports and audit reports from the state (which will include reports from the districts) as per their internal requirements; these will cover the totality of program activities, not just the project financed activities. IDA Supervision: IDA supervision will include a desk reviews of the results of the oversight arrangements by MOHFW, annual audited project financial statements (which will include the funds transferred by MOHFW to the States, along with other central level project expenditures) and MIS information on staffing and training, review of standard

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costs and units as well as training programs; and a review of the sample of state audit reports which will be received by the Directorate. In addition, IDA supervision will cover: (a) field visits to four states and four districts on annual basis including site visits to review a sample of inputs; (b) activities; (c) outputs; (d) program audited financial statements for that location; and (e) overall project operations. IDA will also track the financial management capacity building and enhancement activities by working in close coordination with the financial management group in MOHFW to assess progress on effective integration of all disease control programs within NRHM. Based on the results of the integrated implementation and fiduciary review and a comparison of the actual costs on the basis of the information collected with the standard cost, this method of financing, the standards costs and assurance mechanism will be assessed and redesigned, if necessary. Based on the above arrangements the risk for malaria and kala azar component of the project is assessed as substantial; break up of which is as under: Risk Residual

Risk Rating Risk Mitigation Measures Condition of

Negotiations, Board or Effectiveness (Y/N)

Inherent Risk • Country Level Modest N • Entity Level

(MOHFW) Substantial The MOHFW has limited control over the States.

It is however moving in a positive direction by bringing in financial management of all disease control programs under the supervision of NRHM at central, state and district levels.

N

• Project Level Modest About 85% of the project expenditure will be at the central level (as the procurement is centralized and to be carried out by procurement agent; and expenditure at State level will mainly relate to contractual staff and training.

N

Control Risk • Budgeting Low N • Accounting Moderate An integrated FM manual under NRHM is being

developed to guide the state and district societies N

• Internal Control Substantial The integrated society at the state and district level and strengthened audit assurance mechanisms will help improve the control framework

N

• Funds Flow Low N • Financial

Reporting Substantial

Reporting formats are being standardized under NRHM. Finance staff have been recruited under NRHM who will also be responsible for NVBDCP at the district level. MOHFW is also taking stock of the vacancies in states/ district as a result of attrition based on which another round of recruitment will be planned.

N

• Auditing Moderate N Overall Risk Substantial

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Project Covenants Apart from the covenants regarding audit and submission of Firs, the following covenants are included in the financing agreement: • NVBDCP will establish and retain during project implementation a financial

management cell at the central level with two finance professionals with qualifications acceptable to the Association.

• Appoint a consultant agency as per TOR acceptable to the Association to carry out periodic implementation and fiduciary reviews of decentralized activities financed by IDA in the project states and districts.

Advance: As the disbursement from IDA will be on an annual basis, an advance of US$ 20 million will be provided to GOI to finance the activities of this component in the interim period. This will be adjusted in the last six months of the project. PPF: A PPF for the project was established for US$1 million (reference: IDA-Q5040-IN) for the project. The refinancing date for the PPF has been extended until June 30, 2008. NVBDCP Directorate does not envisage requesting for further extension. Retroactive Financing: The project has initiated agreed preparatory activities at the central level and procurement of drugs and insecticides through UNOPS. Therefore retroactive financing of central level expenditures on procurement will be provided subject to a limit of US$10 million. These will be claimed by the project as part of the financial report for the year 2008-09. B. The Polio Component (about US$270 M) Background and Implementing Entities This component four of the project is estimated to cost about US$270 million to be used for vaccine procurement, which will be financed 100% by IDA, with GOI financing other activities under the program. MOHFW will be the implementing entity. The requirement of polio vaccines for SIAs will be procured by MOHFW from UNICEF acting as supplier. The draft annual agreements between MOHFW and UNICEF will be subject to IDA’s prior review and no objection in a manner that ensures vaccine security. Financial Reporting and Disbursement Arrangements Upon recommendation from the MOHFW, IDA will make direct payments to UNICEF. UNICEF will open a separate sub ledger account for this purpose in its books of account. MOHFW will maintain inventory records in respect of vaccine received and distributed to the consignees. MOHFW will provide to IDA a quarterly report. The report will be based on the reports received from UNICEF. UNICEF will also provide to IDA a statement of funds received from IDA and payments there from on a quarterly basis, in the agreed formats.

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Financial Management Arrangements The proposed component of the project does not require direct involvement of the Borrower in the accounting of funds, which will be the responsibility of UNICEF. The credit proceeds will be disbursed directly by IDA to UNICEF upon the recommendation of MOHFW as stipulated in the procurement agreement to be signed between MOHFW and UNICEF. The expected requirements for vaccines will be agreed upon in advance. Assurance that IDA’s fiduciary requirements are met and the funds are used for the purpose intended with due regard to economy and efficiency will be achieved through the following measures: • Procurement of polio vaccine, estimated at a cumulative value of US$271 million,

will be procured through direct contracting from UNICEF and its terms and conditions of contract shall be subject to approval by the Operations Procurement Review Committee.

• The quarterly reports from UNICEF to IDA and MOHFW will allow close monitoring of the outstanding balance. These reports will include: (a) Balance at the beginning and end of the reporting period; (b) purchase orders placed by UNICEF during the period; (c) expenditures from the related procurement account during the period; and (d) actual quantities of polio vaccines delivered during the quarter. From these reports, IDA will be in a position to verify expenditure before any subsequent disbursements; and

• Quarterly reports from MOHFW to IDA will include polio vaccine received and delivered.

Audit: The Project will rely on UNICEF’s internal controls on use of funds, procurement of vaccine and utilization thereof and the exemption to receive audit report for this component of the project has been received from IDA’s Financial Management and Operations Review Committee. However IDA will retain the option to request for an audit. Based on the above arrangements, the risk for the Polio Component of the project is assessed as low. Retroactive Financing: No retroactive financing under this component of the project is allowed.

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Annex 8: Procurement Arrangements

A. The Vector Borne Disease Component General This component envisages large scale procurement of pharmaceuticals, insecticides, long lasting insecticide treated nets, diagnostic kits, vehicles and services etc. while no civil works are planned under the project. About 80% of total project cost is estimated to be incurred on procurement of goods and services. In the light of findings of the Detailed Implementation Review (DIR) of the previous IDA funded malaria control project (MCP), it is critical to ensure more efficient and transparent procurement arrangements for the success of this sub-project. Implementing Agencies handling procurement The sub-project will cover selected high burden districts among the diseases prone states. Initially the procurement under the sub-project will only be handled at National level40. The proposed assessment of the procurement capacities of the states (which MOHFW is currently taking up in association with IDA and DFID) will determine the decision on decentralizing procurement to states or state agencies found to have satisfactory capacity. The details of items to be procured at GOI level are indicated in the Table 8.1.

Table 8.1: Items to be procured at Central Level

Pharmaceuticals and Medical

Supplies

Other Goods Consultancy Services Non-Consultancy

Services Procurement of RDK, ACT, Drugs for severe Malaria, Rapid diagnostic kits, Miltefosine or other second line drugs etc.

Procurement of LLIN, Insecticides for IRS and treatment of bed nets, Vehicles, Furniture, Computer hardware and software, laboratory

Hiring consultant agencies for: Service delivery, Procurement, BCC, development and translation of training manuals/modules, operational research, impact evaluation, Quality Assurance and improvement, Monitoring and Evaluation, MIS software updating and maintenance, Development and implementation of Geographic Information System, EMP

Printing and publication of modules, etc.

40 The recruitment of contractual staff at regional, state and district levels will be as per the procedure described in Annexure 6. Apart from expenditure on contractual staff, there will be some expenditure on training and mobility of staff at decentralized levels, which may involve a few very low value purchases of routine items. These expenditures (totaling to US$37 Million) will be monitored as per the procedure described in Annexure 6 and no procurement post review will be conducted for these transactions. These transactions will not be governed by the procurement arrangement described in this Annexure.

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Pharmaceuticals and Medical

Supplies

Other Goods Consultancy Services Non-Consultancy

Services equipment etc. implementation, supply chain

management etc. Total (US$58 M) Total (US$76 M) Total (US$36 M) Total (US$1M)

Assessment of the Procurement Capacity of the Implementing Agencies Broader procurement related policies The Constitution of India (Seventh Schedule) lists specific subjects in which the Union Government or the State Government alone can make laws and concurrent subjects in which both the Union and State governments can make laws. Procurement falls in the concurrent list. Procurement of goods/works and services by MOHFW and the State Governments (except for Tamil Nadu and Karnataka, who have passed their own procurement legislations) is regulated mainly by the General Financial Rules (GFR), 2005; State Finance Rules, Indian Contract Act 1872 as amended to date and the Sales of Goods Act. Other policy interventions of Central Vigilance Commission and the Right to Information Act also potentially impact government procurement systems. Policies related to Health Sector Procurement Since procurement of drugs is a specialized subject, further guidelines have been issued by MOHFW to regulate drug procurement. Salient feature of the guidelines issued by MOHFW are:

• The bidder should be in possession of drug license for manufacturing and sale of the drug on the date of tender opening.

• The bidder should be in possession of Good Manufacturing Practice (GMP) certificate for at least two years, which should be valid on the date of tender opening.

• The bidder should not have been convicted. A certificate from the State Drug authority should support this.

• The bidder should have proper arrangements for maintaining cold chain during storage/transit, whenever needed.

• Apart from the sample to be tested by the inspectors, supplier should also test the drugs and produce test results to the inspector at the time of inspection.

• At the time of offering for inspection the drugs should not have crossed 1/6th of the life, and should have a shelf life of not less than that specified in the tender from the date of manufacture.

Each State Government has also issued further instructions which are applicable for health sector procurement in the state. These are mainly based on policy of MOHFW. For example Maharashtra has recently introduced the health sector procurement policy.

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Country/State Procurement Assessments A Country Procurement Assessment Report (CPAR) was prepared in 2001, which provides an understanding/overview of GOI’s National Procurement System. State Procurement Assessment Reports (SPAR) were also prepared for the States of Karnataka, Tamil Nadu, Maharashtra and Uttar Pradesh in 2002 and 2003. Based on these assessments, the existing basic framework of public procurement rules and procedures in India requires open tenders to all qualified firms without discrimination, use of non-discriminatory tender documents, public bid opening, and selection of the most advantageous contractor/supplier. However, the various assessments (CPAR/SPAR) revealed significant weaknesses and lack of compliance with the basic framework of rules and procedures. These included the absence of: a dedicated policy making department, a legal framework, credible complaint/ challenge/ grievance procedures, and the standard bidding documents. The assessments also highlighted cases of preferential treatment in procurement, delays in tender processing and award decisions, use of two envelope system and incidents of inappropriate negotiations. Procurement Capacity Assessment for the Sub-project Procurement capacity assessment studies conducted by IDA for some health sector projects in India have pointed out issues such as weak procurement organization, problems due to use of PSAs, delays in finalization of annual procurement plans and poor quality of procurement plans, ambiguous and incomplete specifications for equipment and drugs, delays in procurement decisions including delay in technical evaluation, piece-meal procurement by implementing entities, non availability of appropriate Standard Bidding Document (SBD) for carrying out procurement on rate contract basis, absence of procurement manual, quality assurance and inspection of goods, weak supply chain management, poor logistics and storage facilities, low capacity of procurement personnel, absence of post-award reviews, and weak complaint handling mechanisms etc. IDA conducted a SOE review for the state of Chhattisgarh during 2007. Among other irregularities, the review reported many cases of splitting of contracts to avoid prior review and poor procurement documentation. These findings are equally applicable for the current sub-project as the implementing agencies are the same. To understand the perspective of the private sector, MOHFW conducted a market survey of manufacturers of health sector products in 2006 under funding from DFID and technical guidance of IDA. The views of the manufacturers as found by this market survey are:

• Clarifications sought are not responded on time. • Delay in refund of bid security as well as payments due resulting in huge money

blockage. • Reasons for rejections are generally not communicated. • Lack of adequate publicity. • Bid Security too high.

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• Tender process too lengthy and documents complicated. • Delay in award of tenders. • Qualifying criteria too stringent. • Non availability of entire product range (own manufacturing). • Separate packaging criteria for government tender (unlike regular pack sold in

retail). • Required resources for bidding and follow ups not cost effective. • Distribution cost - in many instances the receiving party is unaware of the

delivery. • Delay in quality checks of the delivered goods.

The procurement capacity assessment of the implementing agencies for the current sub-project was carried out by IDA which pointed out to specific weaknesses such as lack of trained procurement staff, intentional splitting of Contracts (in the previous project) to avoid use of more competitive procurement procedures, delays in contract awards due to time taken in evaluation/getting IFD clearance, etc. and the stocks/drugs are allocated based on the past use rather than the forecasted disease burden. The Detailed Implementation Review (DIR) of five health sector projects including the Malaria Control Project (MCP), which was conducted during 2006-07, came out with following major procurement related findings:

• Conflict of interest due to one entity being made responsible for implementation, procurement and supervision.

• Poorly developed technical specifications. • Unrealistic estimation of unit rates and rejection of bids due to large price

variation. • Low response to bids due to cartel formation and inappropriate lot sizes. • Failure to identify indicators of FandC such as collusion, price fixation, not

awarding contract to lowest evaluated bidder, fraudulent certificates of performance, quality and completion of contract.

• Interference with PSA decision making process and overall poor functioning and suspected FandC in the procurement handled by PSA.

• Poor record keeping and insufficient documentation. • Inadequate follow-up on findings from audit reports. • Poor complaint handling; Lack of effective dispute resolution and/or sanctions. • Weaknesses in Selection of Consultants, NGOs and other Service Providers. • Wide spread problems including indicators of fraud and corruption in

decentralized procurement. • The DIR also identified weaknesses on the part of IDA such as Reviews not

designed to identify indicators of FandC, inadequate assessment of Borrower’s capacity for handling complex procurement and lack of follow-up on the findings of post review.

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Institutional Set-up for Procurement for NVBDCP MOHFW has established an Empowered Procurement Wing (EPW) to professionalize the procurement of health sector goods and services under centrally sponsored health programs. Prior to formation of EPW, MOHFW did not have a Central Procurement Unit and both health and family welfare departments had separate purchase committees. Director (Procurement) under DGHS and Director (SSM) and Director (UIP) under the supply division handled procurement related activities in the Ministry. In addition, program divisions procured their respective requirements either directly or through Procurement Support Agencies (PSAs) which were not handling the procurement on a turn key basis. As per its mandate, EPW is responsible for handling the strategic procurement (such as vaccines) and providing oversight for the procurement handled under different centrally sponsored health schemes. However, in practice EPW plays relatively limited role in supervising the procurement in MOHFW – with the Joint Secretary in charge of EPW acting as a permanent member in the Integrated Purchase Committee (IPC) and the procurement files are routed through EPW on a case by case basis. The services of PSA are being used for handling most of the procurement funded by the domestic budget and the program divisions are interacting directly with PSAs. IDA along with DFID is working closely with EPW in developing it’s capacity; however frequent transfer of senior staff in EPW has hampered this process. Under DFID funding, an internationally selected consultancy firm (Crown Agents) with appropriate technical expertise in pharmaceuticals, biomedical engineering, quality assurance, IT and supply logistics, is helping EPW on day to day basis. DFID is also providing funding for developing a procurement MIS which will cover MOHFW as well as three states (Maharashtra, Madhya Pradesh and Orissa) initially and will form the foundation for moving towards e-Procurement in medium term. As agreed in the DIR action plan, EPW is proposed to be further strengthened so that it could play its designated role effectively. Under the current procurement arrangement for the sub-project, where most of the procurement is to be handled by the procurement agent and NVBDCP is to interact directly with the Procurement Agent, the role of EPW is not significant, and its current lack of capacity will not adversely affect the sub-project implementation. During appraisal the MoHFW confirmed its commitment to maintaining in place a procurement agent acceptable to the Association until local capacity is strengthened. This was restated during negotiations. MOHFW has hired the services of the United Nations Office for Project Services (UNOPS) on May 30, 2007 to act as procurement agent for handling the procurement of health sector goods under donor funded projects. This was following an agreement between IDA and GOI as per which there was the option of either selecting a procurement agent through international competition or select a UN Agency through negotiations to act as procurement agent. The MOHFW opted for the latter option and selected UNOPS as procurement agent after screening some other UN agencies. As per the agreed matrix of responsibilities, UNOPS is handling the procurement on turnkey

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basis and seeking only the financial concurrence of MOHFW before entering into the contract with suppliers. MOHFW is responsible for providing technical specifications, quantity to be procured, delivery schedule and the list of consignees to UNOPS. This arrangement is presently valid up to September 2008 but likely to be extended up to March 200941. MOHFW is initiating action to select another procurement agent to cover post-UNOPS period. UNOPS is not responsible for capacity building/skill transfer to MOHFW, though the officials of MOHFW are free to attend the meetings during the bidding process as observers. UNOPS is following IDA procurement guidelines for all the procurement where it is acting as procurement agent. UNOPS is having a well laid down internal control system in place, which involves review of all the contracts exceeding US$100,000 in value by a committee based in HQ Copenhagen. There is separation of functions viz. the procurement work is done in New Delhi, but is checked and supervised by the Portfolio Manager in Bangkok. UNOPS is also audited by its internal and external auditors. UNOPS has contracted independent agencies for taking up inspections and has been involving independent experts in bid evaluation process. Though there are no explicit performance benchmarks defined in their contract, UNOPS has been able to cut down the time involved in completing the bidding process considerably in comparison to erstwhile Procurement Support Agencies and also able to obtain reasonable price in most of the cases. UNOPS is also acting as supplier in some of the emergency purchases, where it is following its own procurement procedures. UNOPS has set up an office in New Delhi for carrying out procurement for MOHFW. As UNOPS recruited most of staff from the local market with very limited experience in IDA procurement, considerable handholding was required from IDA during the initial six months. However, after this initial period (which has now elapsed), the involvement and handholding from IDA has reduced considerably. Currently Delhi office of UNOPS has three international staff, while remaining 18 employees are locally recruited. UNOPS has engaged three reputed agencies for carrying out inspection of consignments. UNOPS will require training in detecting the indicators of fraud and corruption to mitigate these risks as highlighted by the recently concluded DIR and IDA will arrange for this at the earliest possible. The Directorate of NVBDCP, under the Directorate General of Health Services of MOHFW, is the nodal organization to decide policies, develop evidence based intervention strategies with the support of the research and development organizations, prepare operational tools and guidelines, as well as provide technical guidance and resource support to States which are responsible for the implementation of the program. The Directorate is also responsible for budgeting of centrally financed component and monitoring the program implementation. For effective coordination with the states, the Directorate has twelve divisions, one of them is the procurement division consists of two Joint Directors; one for procurement under domestic budget support (DBS) while another Joint Director is responsible for procurement of insecticides, drugs and equipment under the externally assisted component (EAC). Even if most of the procurement at central 41 Extension of the contract of UNOPS till March 2009 has been agreed by MOHFW in DIR Action Plan

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level shall be handled by UNOPS/Procurement Agent, the Directorate will still be responsible for drafting the technical specifications, demand forecasting and procurement planning, coordination with UNOPS/Procurement Agent, monitoring the state/district level procurement (initially under DBS), inventory management, capacity building of the states, collecting the data regarding the contracts issued under the sub-project and monitoring the end use of supplies made etc. Under NVBDCP, the Regional Directorates for health and family welfare, located at various state capitals, are responsible for coordination and supervision of all activities at the state and below level. They are also responsible for monitoring the therapeutic efficacy of anti malaria drugs, insecticide resistance to vectors as well as internal quality assurance of microscopy including training of laboratory technicians. As there is no procurement to be handled at decentralized level initially, the role of the Regional Directorates, state integrated NRHM health societies and District health societies will be only limited to implementation of the sub-project. National Institute for Malaria Research (NIMR) and Rajendra Memorial Research Institute (RMRI) under the Department of Medical Research of MOHFW will also be acting as implementing agency for carrying out some technical studies through its field offices and may handle some very low value procurement mainly consumables. IV. Major Risks related to procurement and Mitigation Plan The following table lists major procurement related risks and the mitigation plan. The risk ratings have been decided based on both the probability of occurrence of various risk factors as well as their likely impact. Though the probability of the incidences of fraud and corruption in the procurement process for the sub-project is considered to be low, its impact especially on the sub-project development objective and on the reputation of Government and IDA is considered to be very adverse and hence FandC risk rating is determined to be Substantial. Based on this and other risk factors, the overall residual procurement risk rating for the sub-project is proposed as “Substantial”. Some of the broader risks and mitigation measures are also covered in the Joint Action Plan prepared in response to health sector DIR, and are captured in Governance and Accountability Action Plan (GAAP) available at Annexure 9. It may be noted that many of the risk mitigation measures will be implemented by UNOPS/Procurement Agent on behalf of MOHFW.

Table 8.2: Procurement Risk and Mitigation Plan

Risk Factor Initial Risk Mitigation Measure Completion Date Residual RiskFandC risk (including collusion and outside interference) in contracting process

High • Use of a procurement agent • Introduction of software for detection

of FandC indicators • Measures to improve competition such

as broad technical specifications, realistic post qualification criteria, correct lot sizes etc.

• Better disclosure, complaint handling, MIS, documentation, etc.

• Training in detecting FandC indicators

Ongoing December 2008 Ongoing Ongoing December 2008

Substantial

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Risk Factor Initial Risk Mitigation Measure Completion Date Residual RiskInefficiencies and delays in procurement process

High • Use of a procurement agent • GPN issued in UNDB and dg market

to inform GOI’s intent to introduce LLINs in the national program.

• Moving to E-Procurement • Recruitment of procurement staff at

Directorate

Ongoing Completed December 2009 December 2008

Substantial

Insufficient competition in procurement

High • Take measures to improve the competition

• Build-up the cost database • Pre-dispatch and post dispatch

inspections

Ongoing December 2008 Ongoing

Substantial

Inadequate understanding of procuring services

Substantial • Use of an appropriate agency to support service contracting

Beginning with the first contract

Medium

Overall Risk High Substantial Agreed Procurement Arrangements Procurement Plan For each major contract to be financed by IDA, the different procurement methods or consultant selection methods, the need for prequalification, estimated costs, prior review requirements, and time frame are agreed between the Borrower and IDA project team in the Procurement Plan. The Procurement Plan will be updated at least annually or as required to reflect the actual project implementation needs and improvements in institutional capacity. It will also be available in the Project’s database and in IDA’s external website. MOHFW has prepared the procurement plan for ICB/NCB procurement and major consultancies to be taken up during the first 18 months of the sub-project, which is attached at Appendix 1. This plan will be published also on MOHFW website. It may be noted that Rapid Diagnostic Kits for Kala Azar and MILTEFOSINE Capsules (50mg and 10mg) are proprietary items and will be procured on Direct Contracting basis. Procurement of IEC services from Prasar Bharti (for Doordarshan, the state television channel and the All India Radio, the state radio channel), which is a Government owned agency and release in private print and electronic media through DAVP (a Government Department acting as implementing agency) may be considered on single source basis (with prior review of IDA) as per the details provided in Procurement Plan, provided these agencies agree to use the contract format acceptable to IDA. At state level also, state information department (similar to DAVP at central level) may be assigned the responsibility to implement IEC campaigns (once the state level procurement is agreed). Some NGOs may also be contracted for delivery of services, monitoring etc. on single source basis due to their unique qualifications/ experience and presence in sub-project states.

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Advance Contracting MOHFW has initiated the procurement process for Synthetic Pyrethroids (WDP), Synthetic Pyrethroids (Liquid), Rapid Diagnostic Test Kits for Malaria, Rapid Diagnostic Test Kits for Kala Azar, Capsule MILTEFOSINE (50mg) and Capsule MILTEFOSINE (10 mg), Combi Blister Packs (Artesunate + Sulphadoxine Pyrmethamine Tablets) for adults, Tablet Artesunate (50mg) and Tablet Sulphadoxine Pyrmethamine (500 mg) for children; and Arteether Injections. GFATM procurement is also being conducted along with IDA funded procurement under the same bid documents (however IDA is not taking any fiduciary responsibility for the GFATM funded procurement). In the procurement process conducted so far, some indicators of potential collusion among bidders have been observed, which have been addressed appropriately. Procurement Manual In case the procurement is to be decentralized to the state level in future based on the outcomes of ongoing capacity assessment of the state level agencies, MOHFW will prepare a procurement manual to guide the implementing agencies at all the levels in handling the procurement. This manual will be shared with IDA and finalized before delegating any procurement. All the contracts issued under the sub-project will follow the World Bank’s Guidelines: Procurement under IBRD Loans and IDA Credits” dated May 2004; and “Guidelines: Selection and Employment of Consultants by World Bank Borrowers” dated May 2004 respectively. In case of any inconsistency between the procurement manual and IDA Guidelines, the latter will prevail. Procurement Methods Table 8.3 given below gives highlight of the various procurement procedures42 to be used for NVBDCP. These along with agreed thresholds will be reproduced in the procurement plan. The thresholds indicated in the following table is for the current implementing agencies and in case the decentralized procurement is used in the future, the thresholds may be revised for the state level procurement agencies.

Table 8.3: Procurement Methods to be used for NVBDCP

Category Method of Procurement Threshold (US$ Equivalent) ICB >1,000,000 LIB wherever agreed by IDA NCB Up to 1,000,000 Shopping Up to 50,000 DC As per para 3.6 of Guidelines

Goods and Non-consultant services

Procurement from UN Agencies

As per para 3.9 of Guidelines

42 If bids are called concurrently for several lots/ schedules in a package and cross discounts are invited, the aggregate value of the total package will form the basis to determine the procurement method as well as the review requirements

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Category Method of Procurement Threshold (US$ Equivalent) CQS/LCS Up to 100,000 SSS Up to 50,000 Service Delivery contractor procedure

As per para 3.21 of Guidelines (selection procedure to be agreed)

Individuals Up to 50,000 (as per para 5.2 to 5.4 of Guidelines)

Use of UN Agencies As per para 3.15 of Guidelines Use of NGO As per para 3.16 of Guidelines

Consultants’ Services

QCBS (i) International shortlist (ii) Shortlist may comprise national consultants only

QCBS (or QBS/FBS if agreed with IDA) for all other cases >500,000 Up to 500,000

IDA’s SBD and Standard RFP, as agreed with IDA, will be used for all procurement of goods and consultancy under the sub-project. In addition to IDA’s Procurement and Consultants’ Guidelines and SBD/RFP Documents, Malaria Tool Kit published by IDA may also be referred for procurement and supply management. The use of WHO pre-qualified suppliers or suppliers recommended by WHOPES for use or application in public health (as described in the Tool Kit) may also be considered provided it does not adversely affect the competition and is cost effective.

National Competitive Bidding (NCB) will be conducted in accordance with paragraph 3.3 and 3.4 of the Guidelines and the following provisions:

• Only the model bidding documents for NCB agreed with the GOI Task Force (and as amended for time to time), shall be used for bidding.

• Invitations to bid shall be advertised in at least one widely circulated national daily newspaper, at least 30 days prior to the deadline for the submission of bids.

• No special preference will be accorded to any bidder either for price or for other terms and conditions when competing with foreign bidders, state-owned enterprises, small-scale enterprises or enterprises from any given State.

• Except with the prior concurrence of IDA, there shall be no negotiation of price with the bidders, even with the lowest evaluated bidder.

• Extension of bid validity shall not be allowed without the prior concurrence of IDA (a) for the first request for extension if it is longer than four weeks; and (b) for all subsequent requests for extension irrespective of the period (such concurrence will be considered by IDA only in cases of Force Majeure and circumstances beyond the control of the Purchaser/Employer).

• Re-bidding shall not be carried out without the prior concurrence of IDA. The system of rejecting bids outside a pre-determined margin or "bracket" of prices shall not be used in the sub-project.

• Rate contracts entered into by Directorate General of Supplies and Disposals will not be acceptable as a substitute for NCB procedures. Such contracts will be acceptable however for any procurement under the Shopping procedures.

109

• Two or three envelope system will not be used. Use of Procurement Agent Until such time the procurement and supply management capacities of the implementing agencies are developed to the satisfaction of IDA, all ICB/LIB and NCB procurement above US$100,000 43 will be carried out by a qualified procurement agent or through a UN agency hired to do so on turn-key basis (viz. from receipt of the indent till the delivery of the goods to consignees). In this regard, the MOHFW has already selected UNOPS to act as procurement agent for central health sector projects including NVBDCP. The procurement agent (commercial or UN agency acting as procurement agent) will follow the IDA Guidelines dated May 2004 and other procurement arrangements agreed for the sub-project. The Procurement Support Agencies (PSA) are not to be used at any level until otherwise agreed by IDA. The procurement of services (both consultancy and non-consultancy) will also be supported by an appropriate agency (acceptable to IDA) till the implementing agencies develop their in-house capacity. The role of this agency will be for handling the selection process up to finalizing the contract award recommendations. MOHFW will provide technical inputs (like drafting the Terms of References and providing inputs for technical evaluation) and the contract shall be signed and managed by MOHFW. NVBDCP Directorate of MOHFW could directly handle the low value procurement below US$100,000. NIMR and RMRI may also handle some very low value procurement on its own following the agreed procurement arrangements. Roadmap for Decentralization of Procurement The National Rural Health Mission (NRHM) of the Government of India envisions the decentralization of the health sector procurement to the states. This is important from the sustainability perspective and use of the procurement agent, as described above, is suggested only till such decentralization. IDA is currently working with MOHFW and DFID to assess the procurement capacities of selected state level procurement agencies based on accepted standards for health sector procurement including having adequate systems and procedures, internal controls, etc. Based on this assessment, a plan shall be developed for strengthening the capacity in identified areas of weakness, which is likely to be financed by DFID through a Technical Assistance. Following this process, these state level agencies could be entrusted with responsibility to handle the procurement under the sub-project at decentralized level and the central level procurement will be progressively decentralized. Procurement MIS A management information system (MIS) was developed under the previous project, which requires certain updating. Until such time the computerized MIS system (in which contract database will be a module) becomes operational, the manual system of collecting 43 Procurement of pharmaceuticals and medical supplies shall be taken up only through ICB/LIB until the concerns regarding revised Schedule M have been addressed in a way that is satisfactory to the Bank

110

contract data will be put in place. This is not a major issue as there is no decentralized procurement initially. The format and frequency for collecting the contract data will be agreed with IDA based on the post review plans. Borrower’s Procurement Audit Following procurement audit will be conducted by the MOHFW for the sub-project:

• Procurement Audit by GOI: MOHFW will also hire an independent agency for undertaking yearly post review of the contracts awarded by the program implementing agencies at all levels after the decentralized procurement is agreed. The TOR for this agency shall be shared with IDA for no objection. The report submitted by the consultant will be part of the consolidated audit reports to be submitted to IDA.

• CAG Audit: The Comptroller and Auditor General (CAG) of India also conducts

the procurement audit (as part of the financial audit) of MOHFW. In case there is any procurement related observation made by CAG in its audit report, the same shall be shared with IDA along with the comments of MOHFW.

These audits are only to provide additional comfort on fiduciary compliance and IDA will be conducting its own prior and post reviews as per Guidelines. Procurement Staff With most of the procurement to be handled by the procurement agent, the role of NVBDCP Directorate will be to directly handle low value procurement (below US$ 100,000), coordinate with the procurement agent, monitoring the stock position and quality of supplies; development of specifications, supply chain management, quality management, procurement planning, implementation of risk mitigation plan and service procurement (as and when capacity is built up for this), monitoring the decentralized procurement (as and when allowed), etc. For playing this role effectively the NVBDCP has recruited one procurement consultant (a retired officer) last year under the sub-project and another procurement consultant (financed by GFATM) recently who will work for both IDA and GFATM funded projects. Another procurement consultant is likely to join NVBDCP Directorate within 3 months of the effectiveness of Credit. These consultants will also be required to be deputed to appropriate training program. Disclosure Invitation for Bids (IFB) for goods and equipment for all ICB contracts and advertisement for calling of Letters of Expression of Interest (EOI) for short listing of consultants for services costing more than US$250,000 equivalent will be published in UNDB and dgMarket as well as procurement agent’s website. Apart from this IDA’s disclosure requirement as listed in Appendix 2, will be applicable for the sub-project. MOHFW will also disclose the contract opportunities, bid documents and contract award

111

information on their website (which is also in line with the CVC directives) and may also put the information required under suo moto disclosure under RTI Act on their website. Complaint Handling Mechanism In order to deal with the complaints received from contractor/suppliers effectively, a complaint handling mechanism will be developed at all the levels. On receipt of complaints, immediate action will be initiated to redress grievances. All complaints will be dealt with at levels higher than that of the level at which the procurement process was undertaken. If the complaint is received prior to award of the contract, the complaint shall be taken into account while considering the award of the contract. If, after contract award, a protest or complaint is received from bidders, it will be examined and if necessary, the contract award will be reconsidered. The procurement agent will deal with the complaints pertaining to the procurement handled by it. Sanction/Debarment/Blacklisting In case of noticing any corrupt or fraudulent practice during the procurement process, the Government of India (or the state government once the decentralized procurement is permitted) will take action against the involved bidders/suppliers as per its administrative procedure. Such adverse action taken by the Government could be treated as evidence of poor performance of such bidders participating in the future bidding processes. In addition, IDA could also initiate appropriate action including sanction/debarment of involved parties as per the Procurement/Consultant Guidelines. Mis-procurement The goods and services that have not been procured in accordance with agreed procurement procedure, as the case may be, shall be treated as mis-procurement. IDA will cancel that portion of the credit allocated to the goods and services that have been mis-procured. Procurement Supervision The frequency of supervision missions will be as per the existing guidelines and the Designated Procurement Specialist (DPS) will be part of the implementation supervision missions. It is estimated that the contracts worth approximately US$140 Million will be subject to prior review by IDA while the remaining (with cumulative value of US$34 Million) will be post reviewed. The prior review and post review arrangements are described in the following paragraphs.

112

Prior Review

Thresholds for prior review by IDA are:

Goods: All contracts more than US$1.0 million equivalent Services: All contracts more than US$1.0 million equivalent (other than consultancy) Consultancy Services: > US$200,000 equivalent for firms; and > US$50,000 equivalent for individuals

In addition, all consultancy contracts to be issued on single-source basis exceeding US$ 50,000 in value to consultancy firms shall be subject to prior review. In case of single source contract to individuals, the qualifications, experience, terms of reference and terms of employment shall be subject to prior review. These thresholds are based on the assessed risk rating of the current procurement agent (UNOPS) for all ICB/LIB and NCB contracts above US$100,000 and for MOHFW for low value contracts below US$100,000, which is considered to be “Medium”. In case, other procurement agencies/implementing agencies also handle the procurement in future, the prior review thresholds shall be adjusted based on the risk ratings assessed for such agencies. The prior review thresholds shall also be indicated in the procurement plan. The procurement plan will be updated annually and will reflect the change in prior review thresholds, if any. Post Award Review by IDA

All contracts below the prior review threshold procured will be subject to periodic post review (in accordance with Paragraph 5 of Appendix 1 to IDA’s Procurement Guidelines) on a sample basis. This also includes those contracts handled by the procurement agent (or the UN agency acting as procurement agent) which are not prior reviewed by IDA. These reviews are meant to ensure that the agreed procurement procedures are being followed. The percentage of the contracts to be reviewed shall be based on the risk rating (15% based on the current “Substantial” risk rating of the sub-project but may change in future if risk rating is revised) and the sample shall be representative viz. various procurement methods and sizes of the contracts shall be proportionally included in the sample to the extent possible. The sample size may be increased or decreased based on the findings of the post reviews. The ex-post review by IDA will be conducted either by IDA staff or by consultant hired by IDA. MOHFW will implement a document management and record-keeping system to ensure that the data and documentation pertaining to all the contracts are kept systematically by the implementing agencies and are provided to IDA in a timely manner.

113

B. The Polio Component General This component of the project is estimated to cost about US$270 million, which will be financed 100% by IDA. Under this component, the project will support only purchase of polio vaccines from UNICEF (acting as a supplier) to cover the requirements for 2008-09 (July onwards), 2009-10 and 2010-11. Terms and conditions of contract shall be subject to approval by the Operations Procurement Review Committee. Implementing Agencies handling procurement All the procurement of vaccine will be handled directly by MOHFW without involving a procurement agent or procurement support agencies. MOHFW has already been handling the procurement of vaccine including polio vaccines from UNICEF and hence have the necessary capacity and experience to continue the same under IDA funding. Major Risks related to procurement and Mitigation Plan The requirement of polio vaccines for SIAs will be procured by MOHFW from UNICEF acting as a supplier. The procurement risk for this component is considered to be low. No specific risk mitigation measures are being proposed for this component. Agreed Procurement Arrangements MOHFW will use the mutually agreed upon Agreement format for the purchase of polio vaccines from UNICEF; each such Agreement will be subject to prior review by IDA.

11

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3

Appendix 2 to Annex 8: Procurement disclosure Requirements as per IDA’s Guidelines 1. Contract Awards for ICB and LIB: Within two weeks of receiving IDA’s No Objection to the recommendation of contract award, the Borrower shall publish in UNDB on-line and in dgMarket the results identifying the bid and lot numbers and the following information:

(a) name of each bidder who submitted a bid; (b) bid prices as read out at bid opening; (c) name and evaluated prices of each bid that was evaluated; (d) name of bidders whose bids were rejected and the reasons for their rejection; and (e) name of the winning bidder, and the price it offered, as well as the duration and

summary scope of the contract awarded. In the publication of Contract Award referred above, the Borrower shall specify that any bidder who wishes to ascertain the ground on which its bid was not selected, should request an explanation from the Borrower. The Borrower shall promptly provide an explanation of why such bid was not selected, either in writing and / or in a debriefing meeting, at the option of the Borrower. The requesting bidder shall bear all the costs of attending such a debriefing. If after publication of the results of evaluation, the Borrower receives protest or complaints from bidders, a copy of the complaint and a copy of the Borrower's response shall be sent to IDA for information. If as result of analysis of a protest the borrower changes its contract award recommendation, the reasons for such decision and a revised evaluation report shall be submitted to IDA for no objection. The Borrower shall provide a republication of the contract award. 2. Contract awards for National Competitive Bidding: Publication of results of evaluation and of the award of contract consisting of the same information as mentioned above for ICB and LIB. 3. Contract Awards for Direct Contracting: After the contract signature, the Borrower shall publish in UNDB on-line and in dgMarket the:

(a) name of the contractor; (b) price; (c) duration; and (d) summary scope of the contract.

This publication may be done quarterly and in the format of a summarized table covering the previous period. 4. Contract Awards for Consultancies: After the award of contract, the borrower shall publish in UNDB on-line and in dgMarket the following information:

(a) the names of all consultants who submitted proposals; (b) the technical points assigned to each consultant; (c) the evaluated prices of each consultant;

117

(d) the final point ranking of the consultants; (e) the name of the winning consultant and the price, duration, and summary scope of

the contract. The same information shall be sent to all consultants who have submitted proposals. 5. Contract Awards for Selection Based on the Consultants’ Qualifications (CQS) and Single Source Selection (SSS): The Borrower shall publish in UNDB on-line and in dgMarket the

(a) name of the consultant to which the contract was awarded, (b) the price (c) duration, and (d) scope of the contract.

This publication may be done quarterly and in the format of a summarized table covering the previous period.

118

Annex 9: Governance and Accountability Action Plan (GAAP)

Introduction The Ministry of Health and Family Welfare (MOHFW) is fully committed to improve the governance and accountability in all centrally sponsored programs including the NVBDCP by ensuring efficient program design and management, sound financial management and better competition and transparency in procurement and supply of health sector goods and services required to deliver high quality services. Scope and Purpose MOHFW has developed this Governance and Accountability Action Plan (GAAP), in consultation with IDA to address critical operational concerns related to program management, financial management and procurement in NVBDCP. The key issues and actions to address these concerns are included in the matrix below. The GAAP applies to NVBDCP supported by IDA articulating the specific roles and responsibilities of different stakeholders (public, private and civil society institutions). The GAAP will be a dynamic document and will be strengthened, as necessary, based on lessons learned during the implementation of NVBDCP and other health sector projects. While MOHFW will have the overall responsibility for this GAAP, the Directorate of the NVBDCP will be responsible for implementing program specific actions listed in the attached Matrix and will also act as a nodal point to co-ordinate with the states and other agencies for effective implementation of the GAAP. Project States will be responsible for implementing the relevant actions by district and sub-district level implementing entities. As the procurement above the agreed threshold will be handled by the Procurement Agent, some of the agreed actions may be completed by the Procurement Agent. However, NVBDCP will still have overall responsibility for these actions. GAAP in the Context of Prior Agreements and Actions with GOI This GAAP for NVBDCP incorporates a number of agreements previously reached with the GOI as part of the Joint Action Plans of March 2008 developed in response to the Detailed Implementation Review (DIR) of health sector projects in India. Various institutional mechanisms - such as NVBDCP technical teams with state focal points (for technical guidance, program management and implementation oversight), Financial Management Group (for financial management), NVBDCP Procurement Unit (for procurement of services, monitoring of procurement undertaken by procurement agent and supply chain management) and the Empowered Procurement Wing (for establishment and updating of broader procurement policies and standards for the sector including procurement capacity building of states) - have been established for this purpose.

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Approximately 85% of the value of the NVBDCP will be reimbursements for central government expenditures, most of which are for procurement which will be carried out based on agreements in the Joint Action Plans to address risks of fraud and corruption and poor quality in pharmaceuticals, medical supplies, and other health sector goods and services. Many of these agreements are already implemented. The MOHFW is carrying out all ICB through an internationally qualified procurement agent and has put in place a number of quality assurance and disclosure mechanisms as detailed below. IDA, the GOI, and other development partners are already advanced in the process of learning how to work with these processes as well as efforts to improve country systems. Table 1 summarizes GAAP provisions for NVBDCP which reflect agreements already reached, being implemented, or planned for implementation. Almost all expenditures planned under components 1 and 2 will be covered by these arrangements. Monitoring of GAAP GAAP will be monitored as part of the implementation Support Missions in addition to the day to day monitoring through meetings etc. with the implementing agencies. MOHFW will be required to submit 6 monthly updates on GAAP. Table 1: GOVERNANCE AND ACCOUNTABILITY ACTION PLAN (GAAP) MATRIX Topic Type of risk Mitigating Action Agency Timeline

Finalizing future lot size, estimated prices and qualification criteria for procurement of commodities, pharmaceuticals and medical supplies based on market surveys (either through collection of primary or secondary data) about availability of products, prices and production capacities of manufactures.

MOHFW

Continuous

Ensuring no splitting of the requirement into smaller packages to avoid prior review or use of more competitive procurement procedures.

MOHFW

Continuous

Procurement Poor market response, procurement delays and higher costs.

Use generic and broad technical specifications, build a database of technical specifications, and use clear and concise bid evaluation criteria.

MOHFW

Continuous

Submission of forged documents to win contracts

Seeking “list of references” in the form of an affidavit in case of supplies made to public sector in past contracts. In the case of supplies made to the private sector in the past, affidavit as well as supporting evidence will be sought.

MOHFW

Continuous

Collusion among bidders and between bidders and purchasers

Including a qualification requirement of a minimum share of at least 20% revenue to be derived from non-Bank financed contracts in bid documents.

MOHFW Continuous

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Topic Type of risk Mitigating Action Agency Timeline Including “independent experts” in the bid evaluation process (also applicable for procurement not handled by procurement agent).

MOHFW Continuous

Establishing a procurement monitoring database/MIS to monitor the procurement. This database could be online with restricted access.

MOHFW By October 1, 2008

Sharing record of public opening of bids for all contracts with the Bank within two working days.

MOHFW

Continuous

Develop and deploy software for early identification of indicators of fraudulent and corrupt practices.

MOHFW By October 1, 2008

Moving to e-procurement. MOHFW By December 2009

Delay in bid evaluation, Inadequate/improper bid evaluation

Use of procurement agent for handling ICB and NCB contracts above US$100,000.

MOHFW

Continuous

Include technical experts in the bid evaluation process

MOHFW Continuous

Include listing and discussion of all complaints received and actions taken in the bid evaluation report.

MOHFW Continuous

Project Execution and Contract Management

Poor quality of commodities

Make WHO GMP (TRS 863) certification mandatory for ICB

MOHFW

Continuous

Ensure 100% validation of existing WHO GMP certificates of all successful bidders recommended for award of the contract.

MOHFW Continuous

Agree on specific actions for GMP certification and implementation arrangements satisfactory for the Association for non-ICB procurement of pharmaceuticals and medical supplies under the project.

MOHFW Before non-ICB procurement is agreed

Ensure Pre-dispatch, post-dispatch and field level inspection for the commodities procured under the project.

MOHFW Continuous

Disclose available information on deregistered pharmaceutical companies on MOHFW website and initiating a process for systematically collecting the data on deregistration from other agencies for future updates.

MOHFW

By October 1, 2008

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Topic Type of risk Mitigating Action Agency Timeline Delays in release of

payment Ensuring payment within 30 working days of receiving the bill with supporting documents from the suppliers or communicating deficiency in the bill within 15 working days.

MOHFW Continuous

Improving the procurement documentation including recording of receipt and distribution of goods.

MOHFW Continuous Sub-optimal use of commodities provided under the project Conducting periodic quality and

quantity review for drugs, pharmaceuticals and medical supplies.

MOHFW

First survey by October 1, 2008

Transparency and disclosure in procurement and program implementation

Inadequate disclosure of project information and citizen oversight

Making publicly available all annual procurement schedules for ICB and NCB promptly after finalization on the NVBDCP website.

MOHFW Continuous

Posting all bidding documents and Notice for inviting Expressions of Interest for all procurements above US$100,000 on the NVBDCP website.

MOHFW Continuous

Making available to any member of the public promptly upon request all shortlist of consultants and in case of pre-qualification, list of pre-qualified contractors and suppliers.

MOHFW

Continuous

Disclosing information on prequalification, all bids received reasons for rejections, and award of contracts on the NVBDCP website.

MOHFW Continuous

Posting annual progress (program and financial information), audit reports and Mid Term Review reports of the program on the NVBDCP website.

MOHFW Continuous

Weak mechanisms for client feedback and program accountability especially for tribal and vulnerable groups.

Contracting at national level with NGO’s to develop appropriate methods and processes for clients feedback and accountability community, block and district level with pilots and scale-up plan before early review.

MOHFW Contract in place by December 1, 2008 for 18 months.

Monitoring and Evaluation

Weak Complaints handling mechanism

With support from technical assistance agencies as needed, develop and announce on project website which has robust and transparent procedures receiving any complaint/feedback availability and quality of essential supplies under the project from village level functionaries and end beneficiaries.

MOHFW By October 2008

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Topic Type of risk Mitigating Action Agency Timeline Reviewing the current protocols for

complaints handling and record keeping in MOHFW and finalize action plan for further improvement, if needed.

MOHFW

By December 2008

Updating the complaint database on a monthly basis.

MOHFW Continuous

Reporting the status of investigation of complaints and measures taken in quarterly progress reports to the Secretary (Health and Family Welfare).

MOHFW Continuous

New Areas Specific to NVBDCP GAAP In addition to risk previously identified and being addressed as part of the IDA-GOI Joint Action Plans, there are several new areas specific to NVBDCP where agreements have been reached to strengthen governance and accountability. These are: decentralized project inputs to be financed by IDA, some additional issues related to procurement and quality of goods and supplies, and strengthened monitoring and evaluation processes. Regarding decentralized expenditures, as part of NVBDCP IDA has agreed to finance state level and below state level contractual staff, their mobility, and training costs. As detailed in Annex 7, these will be financed based on normative unit costs for these inputs at state and district level. IDA disbursements will not be based on detailed audited accounts from sub-national units, as it has been found that it is not feasible to maintain separate records for IDA funding and get them audited. For these expenditures, some risk of improper use, fraud, corruption may still remain. To mitigate this risk, IDA and GOI have agreed on an intensified effort of field level input and output monitoring for a sample of project districts on a semi-annual basis, coupled with a review of project implementation after 18-21 months and possible redesign of the local activities. These arrangements apply largely to component 3 of the project where such expenditures account for a little more than 50% of the proposed project costs. States will sign MOU’s with the national governments to receive project support. These indicate that states accept the project terms and conditions including those of this GAAP. NVBDCP poses some additional specific risks in relation to procurement of pharmaceuticals and goods, such as insecticides and LLINs. Additional measures in the context of the agreed Joint Action Plans will be put in place to address these specific risks.

Some additional mitigation measures are also agreed in relation to strengthening M&E (see Annex 3). These activities are also in component 3, and along with central government contracts for capacity building, account for much of the remaining costs.

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Table 2 places these new actions in GAAP format. Table 2: GOVERNANCE AND ACCOUNTABILITY ACTION PLAN (GAAP) MATRIX Topic Type of risk Mitigating Action Agency Timeline

Late and incomplete financial reports Inadequate financial management which cannot be used to monitor implementation progress. Lack of compliance with established financial and internal controls leading to risks of misappropriation of funds.

Financial management processes for national programs are weak. Financial Management System and internal controls inadequate to mitigate fiduciary risks of decentralized expenditures

Varied quality of audit reports received from external auditors.

New Financial Management unit created under NRHM. New Financial management manual being completed and rolled out. Bank will only reimburse contractual staff, mobility, and training costs at state and district level. Reimbursement will be based on normative cost estimates for state and districts as units of implementation. Additional dedicated review of availability of these inputs and project outputs at state level and significant sample of project districts using multiple measures, including HMIS data, external review organization, survey data using Lot Quality Assurance Sampling. If, based on these reviews and project’s early review at 18-21 months, results are not satisfactory, redesign of local component to satisfaction of the Bank is necessary or state and district cost disbursements can be terminated.

MOHFW MOHFW for HMIS and contracting with external review agency and survey agencies.

New manual ready by Oct. 1, 2008. Additional reviews will be done covering a) 6 of the first

18 districts (year 1)

b) 16 of the 80 districts in phase 2 (year 2)

Bank/GOI will consider possible redesign based on performance after year 2 c) 16 of 139

districts in phase 3 (years3-5)

Establishing an effective coordination mechanism with the Central Insecticides Board to accelerate registration process for insecticides and LLINs in India approved by WHOPES.

MOHFW

By January 1, 2009

Procurement Time taking registration process for insecticides

Issue advance General Procurement Notice asking prospective bidders to get their products registered in India

MOHFW

Completed

Bidders trying to win contracts by submitting forged documents

Seek investigation and prosecution for bidders submitting forged documents and/or for any other legal offence.

MOHFW Continuous

Delay in bid evaluation, Inadequate/ improper bid evaluation

Complete the bid evaluation strictly within the initial validity of bids

MOHFW Continuous

Reduce time and steps required for internal procurement and financial clearance mechanism in MOHFW

MOHFW By October 1, 2008

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Topic Type of risk Mitigating Action Agency Timeline Weak service

procurement processes due to inadequate capacity

Use of an appropriate agency (acceptable to IDA) for supporting the procurement of services

MOHFW Continuous

Project Execution and Contract Management

Poor quality of commodities.

Prepare a protocol for ensuring the quality of medical kits and consumables, which are not governed by WHO GMP

MOHFW By October 1, 2008

Strengthen the capacity at NVBDCP directorate and states for monitoring the procurement agent, inventory and supply management

MOHFW

By December 1, 2008

Inadequate supply chain and storage arrangements.

Assess the adequacy of storage/warehouses and initiate actions to strengthen them under the National Rural Health Mission (NRHM).

MOHFW Assessment by March 31, 2009, strengthening based on assessment needs.

Weak Complaints handling mechanism.

Notifying one senior official at district, state and NVBDCP/MOHFW levels for receiving any complaint/feedback availability and quality of essential supplies under the project from village level functionaries and end beneficiaries.

MOHFW By October 2008

Designating state focal points for all project states from NVBDCP officers with clear terms of reference to provide technical support and implementation oversight.

MOHFW Continuous

Monitoring and Evaluation

Loss of opportunity to apply mid course correction /efficiency gains.

Ensuring bi-annual program reviews satisfactory to the association.

MOHFW Continuous

Reliance on routine projects monitoring data

Use of more data sources such as regular HH surveys and LQAS.

MOHFW Continuous (baseline survey to be completed within six months of effectiveness).

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Annex 10: Economic and Financial Analysis

Economic Analysis The project seeks to reduce malaria burden in selected, highly endemic areas as well as eliminate kala azar. This project supports certain very important interventions such as the introduction of a new diagnosis and treatment protocol, strengthening service delivery mechanisms which are necessary for the effective implementation of the new protocol, a different strategy for effective surveillance, strong emphasis on the availability and use of long lasting insecticidal nets for vector control and so forth. The known interventions in both these diseases are highly cost-effective. Available evidence suggests that all malaria interventions are highly attractive (cost-effective) using a cutoff of US$150 per DALY averted.44 There are two broad types of interventions in Malaria control: case management and prevention. On the prevention side, the review of worldwide trials of ITNs and IRS by Curtis and Mnzava’s suggests that ITNs and IRS have equivalent effectiveness. Similar conclusion is reached also by Lengeler and Sharp (2003) who notes that choosing between IRS and ITNs is “largely a matter of operational feasibility and availability of local resources than one of malaria epidemiology or cost-effectiveness.” Given cost-effectiveness of both the strategies, choice between ITNs and IRS then essentially reduces to operational and logistical challenges in a given context. A number of studies from Sub-Sahara Africa, particularly, in the Gambia, Ghana, and Kenya have shown the provision and insecticide treatment of bed nets to be highly cost-effective under varying conditions.45 A study by Goodman et al. (2001) compared the cost and cost-effectiveness of insecticide-treated bed nets and IRS KwaZulu-Natal in South Africa. The study concludes, “In view of the greater effectiveness of ITBN, policy makers may view ITBN as a cost-effective use of resources, even if the economic costs are higher.”46 Similar conclusions are reached by a recent publication47 in which the authors study five insecticide-treated net programs (Eritrea, Malawi, Tanzania, Togo, Senegal) and two indoor residual spraying programs (Kwa-Zulu-Natal, Mozambique). The study concludes, “In any case, all these vector control programs are excellent public health investments and more such investments should be made as soon as possible. This is a time of unprecedented opportunities for malaria control, with expanding global interest and resources, and also increased commitment

44 Breman, J.G. et al, Conquering malaria, Chapter 21 in Disease Control Priorities in Developing Countries 2006, pages 413-432. 45 Goodman CA., and Mills AJ, (1999), The evidence base on the cost-effectiveness of malaria control measures in Africa, Health Policy and Planning, Review Article, 14(4): 301–312. 46 Goodman CA., et al. (2001), Comparison of the cost and cost-effectiveness of insecticide-treated bednets and residual house-spraying in KwaZulu-Natal, South Africa Tropical Medicine and International Health, Volume 6, No. 4, pp 280-295 April 2001. 47 Yukich, J. et al. (2007), “Operations, costs and cost-effectiveness of five insecticide-treated net programs (Eritrea, Malawi, Tanzania, Togo, Senegal) and two indoor residual spraying programs (Kwa-Zulu-Natal, Mozambique),” Swiss Tropical Institute, Basel, Switzerland.

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by endemic country governments. It is time to substantially bring down the unacceptable burden of disease due to malaria.” On the case management side, the project supports a shift from the current presumptive treatment with chloroquine to treating all confirmed P falciparum malaria cases with ACT. A review of international evidence suggests that a switch from chloroquine to ACT is highly cost-effective at all initial levels of chloroquine resistance above 37%. However, this analysis does not take into account non-health related benefits, especially evidence of income gains or prevention of income losses. Nor does it takes into account the costs of health systems strengthening required to make effective use of ACT. Inclusion of non-health related benefits only increase the attractiveness of switching to ACT. The health systems strengthening costs, on the other hand, may be significant but given the current Indian context in which public health services are being strengthened under NRHM, the system strengthening costs should be relatively low. On the second disease covered in the project, kala azar is one of the most neglected diseases in the world, affecting the poorest segments of rural populations in southern Asia, eastern Africa, and Brazil (Yamey and Torreele 2002).48 In India, kala azar is confined mainly to 52 districts across 4 states of India. In 2006, around 39,000 kala azar cases were reported in the country. However, the joint monitoring mission, carried out by several national and international agencies in two of the nine most endemic districts in 2007, found about 10 fold underreporting of kala azar! About 60-70% of kala azar cases access private sector for the diagnosis and treatment. In addition to wage loss for a significant period, the high cost of diagnosis and treatment tend to impoverish families. JMM team reported that a household spends anywhere between INR 7000 and 10,000 for the diagnosis and treatment of kala azar. Similar findings have been reported in other studies as well. For example, a study examining the epidemiologic, social, and economic impact of KA in a village in Bangladesh found the high cost of diagnosis and treatment, causing substantial emotional and economic hardship for affected families (Ahluwalia et al 2003).49 With effective case management it is possible to eliminate kala azar, and case management is more cost-effective than vector control. Recent studies50 show kala azar treatment to be extremely cost-effective as it costs US$315 per death averted and US$9 per DALY gained.51 To gain a perspective on cost-effectiveness of malaria and kala azar interventions we present cost-effectiveness of a few comparators. Improved case management and immunization (currently undergoing clinical trials) for dengue costs US$587 to US$1440 per DALY averted. Similarly, among interventions against diarrheal disease during the first year of life, oral dehydration therapy costs US$132 to US$2570 per DALY averted and cholera immunizations

48 Yamey G, Torreele E., (2002). The world’s most neglected diseases. BMJ 325: 176-177. 49 Ahluwalia I B et al. (2003). Visceral leishmaniasis: consequences of a neglected disease in a Bangladeshi community. Am. J. Trop. Med. Hyg., 69(6), pp. 624-628. 50 For example, Laxminarayan, R., et al, Intervention Cost-effectiveness: Overview of Main Messages, Chapter 2 in Disease Control Priorities in Developing Countries 2006, pages 35-86. 51 One DALY (Disability-Adjusted Life Year) represents a lost year of healthy life due to poor health or disability and potential years of life lost due to premature death.

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costs US$1658 to US$8274 per DALY averted. Malaria and kala azar interventions, in comparison, are highly cost effective. A small exercise on cost-effectiveness of introducing ACT using Indian data suggests that under the proposed policy, the unit cost of both diagnosis and treatment will be over ten-fold higher than that of current policy (Rs. 7.5 vs. Rs. 77.8).52 Even though the new protocol may appear to be expensive, the real benefits accrue in terms of reduced transmission and reduced mortality. The steep reduction in hospitalizations and mortality as well as the reduction in transmission (as seen in other parts of the world) will more than compensate for the initial increase in costs. With the estimated reduction in transmission, after five years of implementation, the cost of the new policy will only be around 68% more than the current policy (Rs. 1073 million vs. Rs. 1633 million in the 100 districts), but will avert around 66,000 estimated hospitalizations and about 13,200 deaths (see the analysis below). Cost benefit analysis of switching from the current to the new protocol for the diagnosis and treatment of malaria Like many other countries, India is currently considering implementing Artemisinin derivative Combination Therapy (ACT), in at least high endemic districts. ACTs have high efficacy but are also much more expensive - up to 10-20 fold.53 Still, the cost of adopting ACT needs to be assessed and compared with the cost of current protocol being followed in India. Studies have linked the cost of switching from Chloroquine (CQ) to ACT with the level of drug resistance reached. For example, it has been estimated that switching from chloroquine to ACT becomes cost-effective as Chloroquine (CQ) resistance reaches around 37%. Similarly, switching from Sulfadoxine Pyrimethamine (SP) to ACT becomes cost-effective as SP resistance reaches 12%. This low threshold for SP is due to the high growth rate of resistance to SP when it is used as a first line therapy.54 In this note we estimate and compare cost of current protocol with the new protocol involving Rapid Diagnostic Kits (RDKs) and ATCs. The current diagnostic and treatment protocol involves (a) active surveillance with collection of blood smears for all cases with history of fever (both current and those in the past 15 days); (b) presumptive treatment for all cases with history of fever (c) microscopy of all blood smears collected, and (d) use of CQ and PQ/ ACT for confirmed Pf cases. In Table 1, 2 and 3 below, we estimate the cost of current protocol, the cost of new protocol, and incremental costs and benefits of phased transition to new protocol in 100 districts from 2008 to 2012 respectively.

52 Rs. 77.8 = Rs. 65 X (0.4 X Rs. 5+ 0.6 X Rs. 18). 53 Mulligan, J. et al. “The costs of implementing a change in Drug Policy: The case of combination Therapy for Malaria”, London School of Hygiene and Tropical Medicine and Malaria Consortium. 54 Disease control priorities in Developing Countries, 2nd edition, edited by Dean T. Jamison et al., Disease control priorities project (2006), Conquering Malaria, Chapter 21, pp 413-431.

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Table 1: Estimated Costs of Current Protocol in 100 Endemic Districts, 2008 to 2012

Units 2008 2009 2010 2011 2012 Total 2008to 2012

(i) Number of new fever cases in 100 districts Mil. cases 26.60 26.42 28.45 29.24 30.20 140.92[is the same as no. of blood slides collected (BSC); this data pertains to actual BSC from 2001 to 2005]

(ii) Number of new fever cases residing in areas where reported chloroquine resistance is above 25% Mil. cases 0.05 0.05 0.05 0.05 0.05 0.25[assumed to be 50,000 cases in the 100 districts]

(iii) Number of new fever cases residing in areas where reported chloroquine resistance is below 25% Mil. cases 26.55 26.37 28.40 29.19 30.15 140.67

(iv) Cost of treatment for cases in (ii) Mil. Rs. 3.2 3.2 3.2 3.2 3.2 16.22(suspected Pf malaria cases; treated with ACT asfirst-line treatment; cost is Rs. 64.86 per case treated)

(v) Cost of treatment for cases in (iii) Mil. Rs. 66.4 65.9 71.0 73.0 75.4 351.67(these cases are given presumptive treatment formalaria, at Rs. 2.5 per case)

(vi) Total treatment cost Mil. Rs. 69.6 69.2 74.2 76.2 78.6 367.88[= (iv) + (v) ]

(vii) Number of slides taken and tested by microscopy(10% of all fever cases; for surveillance purposes) Mil. slides 26.60 2.64 2.85 2.92 3.02 38.04

(viii) Cost of taking and testing slides Mil. Rs. 133.02 132.12 142.26 146.19 150.99 704.59(Rupees 5 per slide)

(ix) Total cost of treatment and testing Mil. Rs. 202.7 201.3 216.5 222.4 229.6 1072.47[= (vi) + (viii) ]

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Table 2: Estimated Costs of New Protocol in 100 Endemic Districts, 2008 to 2012

(i) Number of new fever cases in 100 districts Mil. cases 13.30 13.21 14.23 14.62 15.10 70.46[50% of BSC]

(ii) Phased area coverage of new protocol % of area 0.5 0.5 1.0 1.0 1.0(50% in the first 2 years and full 100%in 3rd, 4th & 5th year)

(iii) Total cost of treatment and testing in areas not yet under new protocol Mil. Rs. 101.3 100.6 0.0 0.0 0.0 202.0

(iv) Number of new fever cases in areas under new protocol Mil. cases 6.65 6.61 14.23 10.23 7.55 45.3[the number of new fever cases declines by 30% and50% (over the level of the third year) in the fourthand fifth year respectively]

(v) Total cost of testing in areas under new protocol Mil. Rs. 85.1 84.6 182.1 131.0 96.6 579.4[Assumptions: (a) all new fever cases are tested byeither laboratory or via RDKs; (b) 40% are tested through laboratory and 60% through RDKs; [c] costsper case are Rs. 5 and Rs. 18 respectively]

(vi) Number of confirmed Pf cases in areas under new protocol Mil. cases 2.2 2.2 4.7 3.4 2.5 15.1[Assumed to be one-third of all new fever cases inthese areas]

(vii) Cost of treating all confirmed Pf cases with ACT Mil. Rs. 143.8 142.8 307.6 221.3 163.2 978.7(at Rs. 64.86 per case)

(viii) Number of confirmed P Vivax cases in areas under new protocol 4.4 4.4 9.5 6.8 5.0 30.1[Assumed to be two-thirds of all new fever casesin these areas]

(ix) Cost of treating all confirmed P Vivax cases Mil. Rs. 11.1 11.0 23.7 17.0 12.6 75.4(with chloroquine, at Rs. 2.5 per case)

(x) Total cost of treatment and testing in areas under new protocol Mil. Rs. 240.0 238.4 513.3 369.3 272.4 1633.4[= (v) + (vii) + (ix) ]

Table 3: Estimated Incremental Costs and Benefits of Phased Transition to New Protocol, 2008 to 2012

(i) Estimated incremental costs of phased transition Mil. Rs. 37.4 37.1 296.8 146.9 42.8 561.0

(ii) Number of severe cases averted Cases 5,500 11000 16500 19250 13750 66,000

(iii) Number of deaths averted Deaths 1100 2200 3300 3850 2750 13,200

(iv) Economic benefits from averted severe cases Mil. Rs. 16.5 33.0 49.5 57.8 41.3 198.0 (Assuming that about Rs. 3,000 is spent ontreating a severe case of malaria)

(v) Economic benefits from averted deaths Mil. Rs. 396.0 792.0 1188.0 1386.0 990.0 4,752.0 (Assuming each averted death results in 15 yearsof additional life, valued at Rs. 24,000 per year)

(vi) Total incremental economic benefits Mil. Rs. 412.5 825.0 1237.5 1443.8 1031.3 4,950.0 [ = (iv) + (v) ]

(vii) Net Incremental Economic Benefits Mil. Rs. 375.1 787.9 940.7 1296.9 988.4 4,389.0 [ = (vi) - (i) ]

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Financial Analysis Expenditure on VBDCP has increased at the rate of 51% over 8-year (period 1997-98 to 2004-05), but in the last three years alone (2005-08) the expenditure has gone up by 77%. Looking at the past years data on budget allocations and utilization it is clear that both Domestic Budgetary Support (DBS) and Externally Aided Component (EAC) are important funding sources for the program.55 Cumulatively 51% of total budget allocations came from DBS whereas EAC contributed 49% between 1997-98 and 2007-08. On the utilization side, 61% of expenditure was done under DBS and only 39% was under EAC. Looking at the gap between total budget allocations and actual utilization of funds, it turns out that allocations have been higher than the actual expenditure for all the years (refer the table below). The cumulative shortfall in utilization has been around 20%. This shortfall is only 3.3% in case of Domestic Budgetary Support (DBS) while as high as 36.8% for the Externally Aided Component (EAC). The reason for such high shortfall in utilization of EAC allocations has been due to the inability to complete the planned procurement of commodities on account of certain procurement-related issues. As for DBS, in certain years, the expenditure has in fact been higher than the allocations (refer the table below), implying that GOI can enhance resources on its own account even beyond the budgeted amounts if the program so demands.

Table: 3 Budget Allocations to and Actual Expenditure under NVBDCP (INR in million)

Budget Allocations Actual Expenditure Years DBS EAC Total DBS EAC Total

Diff. between Allocation and Expenditures

97-98 1500 500 2000 1380 40 1430 570 98-99 1470 1500 2970 1290 350 1640 1330 99-00 1300 1200 2500 1160 610 1770 730 00-01 1550 1000 2550 1110 790 1900 650 01-02 1250 1000 2250 1380 810 2190 60 02-03 1090 1260 2350 1080 980 2070 280 03-04 1350 1100 2450 1430 580 2010 440 04-05 1460 1230 2690 1500 670 2170 520 05-06 1940 1540 3490 1550 1060 2610 880 06-07* 1380 2340 3720 1670 1520 3190 530 07-08* 1420 2570 3990 1644 2209 3854 136 Total 15710 15240 30960 15194 9619 24834 6126 08-09 3219 1504 4723 N/A N/A N/A N/A Source: Budgets of Directorate of Vector Borne Disease Control Program. DBS = Domestic Budget Support, EAC = for Externally Aided Component. * Expenditure figures are provisional. VBDCP is a part of national disease control program which in turn is a part of National Rural Health Mission (NRHM) – a national flagship program of GOI. There has been a substantial

55 The Bank support has been the most important support under Externally Aided Component. In the last 2-3 years, GFATM has also been funding on control of malaria in India.

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increase in budget allocations under NRHM from Rs. 90360 million in 2006-07 to Rs. 119760 million in 2008-09, about 33% increase.56 Budget allocation to National Disease Control Program itself increased from Rs. 7560 million in 06-07 to Rs. 10720 million in 08-09, or about 42%. GOI is planning to increase budget allocation under NRHM by 40% each year beginning 2008-09 to 2011-2012, the last year of the mission. This substantial increase in central funding combined with the mandated increase in states’ spending is essential for raising total public health spending from the current level of 1% of GDP to 2% of GDP which is the stated objective of the present UPA government.

56 Besides NRHM, which accounts for over 60% of central health spending, other areas where central health spending takes place are administration, public hospitals, medical education and training, and public health.

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Annex 11: Safeguard Policy Issues

VULNERABLE COMMUNITIES’ PLAN A. Legal and Institutional Framework The term ‘vulnerable community’ describes groups with social, cultural, economic and/or political traditions and institutions distinct from the mainstream or dominant society that disadvantage them in the development process. ‘Indigenous people’ (known as ‘Scheduled Tribes’ (ST) or ‘tribal groups’ in India are recognized as vulnerable communities, and so too are the ‘Scheduled Castes’ (SCs) and economically poor (‘Below Poverty Line’ or BPL), including those among minority religions. 'Scheduled Castes ' are those who remain outside the four Hindu castes, and include some professing Buddhism or Sikhism who continue to be socio-economically deprived. Around 8% of India’s total population is ST and 17% is SC; about 27% of the total population is BPL. The Indian Constitution (Article 342) recognizes several communities as STs and SCs and confers a special status on them to make up for their disadvantages. A number of provisions in the Constitution aim to abolish all forms of discrimination against them, and many public programs target SC/STs and/or BPL people. The majority of STs and SCs continue to be vulnerable as reflected by their socio-economic characteristics, (e.g., low literacy, prevalence of poverty - 46% of rural STs are BPL and 35% of urban STs). The Indian Government designates areas where more than 50% of the population is tribal as ‘Scheduled Areas’ or ‘Tribal Sub-Plan’ (TSP) areas. In these areas, the interests of STs are especially protected and various tribal development programs targeted to them. Many districts or parts of districts in the states in this Project, notably Andhra Pradesh (A.P.), Chhattisgarh, Gujarat, Jharkhand, Madhya Pradesh (M.P.), Maharashtra and Orissa, are Scheduled Areas (Table 1) and others are TSP areas. There are no specific laws mandating provision of health care to STs and SCs. However, they are a key focus of the National Health Policy as it is recognized that improving their health is critical to achieving national health goals. As tribal habitations are concentrated in remote, forest or hilly areas the Government has enhanced the facility: population norms for health care infrastructure: one health Sub-centre staffed by an Auxiliary Nurse Midwife (ANM) is to be provided for every 3,000 people in tribal areas (instead of 5,000 people), a Primary Health Center (PHC) with two doctors for 20,000 (instead of 30,000) and a Community Health Center (CHC) with four medical specialists for 80,000 (instead of 100,000). The National Rural Health Mission (NRHM) launched in 2005 seeks to improve access to health care by strengthening the public health system notably with a village-based worker known as the ASHA, greater engagement of the private sector, and increased and flexible finances. It also seeks to enhance community demand for and ownership of services, and coordinated planning and implementation across related sectors such as Women and Child Development and Tribal Affairs. Currently all sectors are mandated to allocate and spend ‘population percentage proportionate’ funds on ST and SC programs.

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B. Baseline Information Information on the major tribes inhabiting the project states and salient demographic and developmental indicator levels are presented in Table 1. There is great diversity in their ethnic and cultural identities, and the environmental and geographical conditions in which they live. Their unique myth and belief systems, family and kinship structures, food and dress habits, housing conditions, political organization and economic pursuits and status influence their concepts of health and sickness, health-seeking behavior, and the pace and magnitude of their acceptance of ‘outside’ interventions. In many tribal areas, traditional panchayats and Tribal Councils deal effectively with tribal issues. In addition to these traditional leadership systems, special legislation, the Panchayat Extension to Scheduled Areas Act, has introduced the ‘modern’ system of panchayats to scheduled areas. The NRHM has enhanced the ability of local panchayats to address local needs and priorities to improve health by providing untied funds to Village Health and Sanitation Committees (VHSCs). Additional funds are provided to the ANM and local panchayats have been mandated to ensure optimal resource utilization.

Table 1. Number of Project Districts, Scheduled areas within Project, Important Tribes, ST Population and Development Indicators *

Development Indicators State/Union

Territory Number of

Project Districts (a)

Number of Scheduled Areas (b)

Number of Important Tribes in

Project Districts

ST Percent of Total Pop.

Sex Ratio

IMR Literacy Rate

Andhra Pradesh

M: 5 M: 4 10 60.0 972 104 37.0

Chhattisgarh M: 16 M: 10 15 31.8 1013 52.1

Gujarat M: 12 M: 7 12 14.8 974 60 47.7

Jharkhand M: 10, KA: 6, M + KA: 5

M: 7, KA: 1, M + KA: 5

10 26.3 987 27.5

Karnataka M: 7 None 12 85

Madhya Pradesh

M: 19 M: 11 17 20.3 975 101 41.2

Maharashtra M: 5 M: 2 16 8.9 973 74 55.2

Orissa M: 13 M: 11 17 22.1 1003 99 22.3

West Bengal KA: 11, M + KA: 1

None 15 5.5 982 85 43.4

Notes: (a) M: number of districts for malaria control; KA: number of districts for kala azar elimination. (b) Scheduled areas are districts or parts of districts with more than 50% ST population. * Number and specific location of districts may still be revised C. Summary of Social Assessment

A Social and Beneficiary Assessment (SABA) was carried out by an independent agency during project preparation to enable tribal communities to participate in preparation of the VBDCP and ensure that the Project is designed and implemented in accordance with their health and socio-cultural needs. It also aimed to achieve a clearer understanding of tribal communities to

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facilitate their informed participation, assess whether the Project will have any adverse impacts on them, and help with the preparation of an indigenous peoples’ plan. The SABA was undertaken in four project states: A.P., Chhattisgarh, M.P. and Orissa. It included a synthesis of available information, interviews with relevant workers and officials, and a household survey using a mix of open- and close-ended questions. In addition tribal groups were consulted through focus group discussions. The key findings and recommendations of the SABA are summarized below, and additional inputs from the consultations are provided in the next section. Surveillance, Case Diagnosis and Management • Personnel at health Sub-centers, village volunteers, functioning laboratories at PHCs/CHCs,

and mobile vans are contributing to improvements in health services and disease surveillance. Rapid Diagnostic Kits (RDKs) and anti-malarial blister packs have also contributed to quick diagnosis and treatment compliance. However, in difficult locations there are deficiencies in supplies, personnel and monitoring which steer the care-seeker to traditional healers or the unorganized private sector. These often dispense non-standardized diagnosis and treatment and may entail greater expenditure. Filling up critical vacancies at peripheral health centers (qualified practitioners, lab technicians, health workers), ensuring that drugs are not stocked out, and frequent monitoring and evaluation are needed to ensure timely diagnosis and effective treatment.

• Public-private partnerships (PPP) have been initiated in many areas. Private nursing homes and clinics report malaria cases to the District Program Officer on a monthly basis and in the event of increases remedial measures are taken by the public health system. This system requires scaling up.

• The risk of VBDs varies seasonally. A Seasonality-based Action Plan was recommended at district level to ensure adequate coverage with drugs/ITNs and reduce the risk of epidemics. Intensified surveillance and information to the public (about what is being done and what it needs to do) using various communication channels were recommended.

• SWOT analysis. The role of health workers/volunteers in implementing programs with a focus on women and children was seen as major strength. It was suggested that they be better skilled and equipped and provided performance-based incentives to enhance effectiveness. Active involvement of panchayats was also seen as strength. Weaknesses to be addressed included: inadequacies in health care system, inter-sectoral coordination, monitoring, and stakeholder involvement in planning, implementation and monitoring. The NRHM was viewed as an opportunity to improve health infrastructure, stakeholder participation, community empowerment, capacity of health/non-health sector staff to address local needs and priorities, use of resources, and M&E. Potential threats were: inappropriate treatment by unqualified service providers, inadequate community mobilization and capacity-building, sub-optimal use or misuse of available resources and staff, and adverse impacts of unplanned development projects.

• Capacity building. Training and regular reorientation were emphasized as ways to remove some of the deficiencies noted in service delivery especially in tribal areas. This will also prevent indiscriminate use of drugs, incomplete treatment and drug resistance. Health worker training to support the efforts of doctors in developing local strategies and planning was also mentioned.

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Integrated Vector Management • Insecticide-Treated Bed-Nets (ITNs) have been distributed free of cost to the very poor by

the Government. The BPL and APL (Above Poverty Line) populations were charged highly-subsidized costs of US$0.25 and US$0.50 respectively. Along with health workers and volunteers, panchayats were involved in ITN distribution and in educating communities about the use of nets, precautions and re-treatment of nets. However, bed-net use ranged from about one-third to two-thirds of those who received them. In tribal communities, the use was particularly low on account of the habit of sleeping in the open, and the traditional belief that forbids sleeping under a ‘foreign’ object such as a roof or net. Because of crowded housing conditions (families have an average of five members), sleeping under one bed net was infeasible. There was also a lack of perceived benefits. Nevertheless, during a malaria epidemic in some villages, children were encouraged to sleep under bed nets. Although bed-nets were reportedly purchased from the market as well, there was very little information on community-owned bed-nets. About one-half of community members expressed their willingness to pay for ITNs supplied by the government. It was recommended that areas be prioritized for bed-net distribution on the basis of risk, a high proportion of Pf cases, and inaccessibility for indoor residual spraying.

• Social marketing was recommended to increase access to ITNs and other health products and services.

• Some positive traditional practices were mentioned such as driving away mosquitoes by burning neem leaves, other forest herbs, cow dung or paddy stubble. Some tribes use repellant body oils.

• Although it was widely known that mosquitoes cause malaria, there was little knowledge of mosquito breeding habits. Only in one study area were people aware of the need to cover stored water, spray kerosene oil over stagnant water, etc. Given open drainage systems, garbage disposal and ‘toilets’, the need to address environmental sanitation and personal hygiene to reduce vector-borne diseases was discussed.

• Some villages had not been sprayed for a year or so. Lack of advance information for IRS reduced its coverage. However, tribal people were also reluctant to allow their homes to be sprayed as tradition holds that family deities and ancestors’ souls live inside and protect surviving children. The entry of strangers is considered polluting. The involvement of PRIs, however, has led to improved acceptance. In addition to IRS, some villages (especially in Chhattisgarh) are using biological control measures (e.g., larvivorous fish).

Community Awareness, Attitudes, Beliefs, Practices. • In inaccessible villages with deficient services, the dependence of tribal people (particularly

‘primitive’ tribes) on tribal medicine men is absolute. However, traditional knowledge about herbs, plants, etc. is eroding with time. About half of the tribal people interviewed/consulted voiced a dependence on traditional beliefs, customs and practices, including tribal priests and medicine men. They mentioned consulting public health staff or local doctors only when they were not able to get any relief. However, this is changing gradually in villages that are close to PHCs or have qualified health workers/doctors.

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• Awareness generation campaigns by the government in the past few years did not reach about half of the sample villages. Not unexpectedly, therefore, about half of all respondents continue to have traditional beliefs about the cause of malaria [e.g., the ‘wrath of God’ (20%), witchcraft (15%), strolling in the forest (4%), eating stale food (2%), drinking bad water (1%), etc.]. Although a majority of respondents recognized fever as a symptom of malaria, around one-sixth did not. Similarly, vector breeding sites, prevention and treatment measures, etc. were not widely known. The most common route of information was counselling (inter-personal communication) by health workers or doctors. Tribal people had limited access to radio/TV and posters/newspapers also had minimal reach. Intensified campaigns and improved access to facilities were recommended.

D. Summary of the Consultations with Affected Indigenous Peoples Free, prior and informed consultations were held with tribal communities in the proposed project areas during project preparation. The project background, objectives and purpose of the discussions were explained to the target groups to set the context for consultation. Focus group discussions and individual interviews were conducted. Interactions were also held with non-governmental organizations (NGOs) and community-based organizations (CBOs) such as Self Help Groups or women’s groups (Mahila Mandals), Panchayati Raj Institutions (PRIs), Tribal Councils, etc. that represented tribal groups and were working on public health related programs or issues. Their main points and recommendations are given below. The suggestions made at the consultative workshop held to review the draft VCP and finalize it have also been included. Surveillance, Case Diagnosis and Management • Service delivery related to VBDs is inadequate in many tribal areas. During the monsoon

many PHCs are unable to handle the patient load and replenish stocks. Examination of blood smears for malaria and treatment are often delayed (for three days or more), and hence there is always a risk of the disease spreading. In some PHCs delays occur on account of the lack of a laboratory technician. Multi-purpose Health Workers collect blood smears and provide treatment, but their domiciliary visits are somewhat irregular, owing to the need to cover a large dispersed population. Their capacities and efforts to sensitize and mobilize communities are often limited. The effectiveness of Fever Treatment Depots (FTDs) is also inadequate. Radical treatment is started as soon as fever cases are confirmed positive for malaria, but only at PHCs. Treatment compliance is frequently a challenge as tribal communities tend to take low dosages and resort to local herbal medicines. The Anganwadi Workers (AWWs) under the Integrated Child Development Services Scheme give VBD activities lower priority as they are heavily engaged in maternal and child care.

• Faster and better quality services should be ensured, partly by filling up staff vacancies. The focus of PHCs, Health Workers (HWs) and Volunteers on VBDs needs to be reinforced from time to time through reviews. Information campaigns could help to build people’s trust in HWs and FTDs and should be intensified along with the workers’ capacity building. Stock outs of drugs should not be allowed. Laboratory technicians should be posted full-time in tribal PHCs. Fever detection camps and clinics should be conducted regularly during monsoon months. The roles and responsibilities of AWWs need to be review and prioritized, especially in view of the engagement of ASHAs under NRHM.

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• NGOs could be involved in the program, especially to improve access to tribal populations. Their workers will need training and equipment (e.g., with RDKs).

Integrated Vector Management • Preventive measures such as insecticide spraying are delayed even when a malaria positive

case is diagnosed due to inadequacies in resources, storage space, spraying equipment, etc. Spraying should be timely as well as focal. Spraying activities are undertaken with DDT, malathion or synthetic pyrethroids (in keeping with insecticide policy) but synthetic pyrethroids are preferable because of their quick knockdown effect against vectors. Malathion leaves stains on walls and furniture and is not favored. Micro-planning should be done to ensure timely resource mobilization, adequate infrastructure and equipment, optimal coverage and quality of IRS. The insecticide policy should be reviewed in view of community resistance/acceptance of different types.

• The supply of free or subsidized ITNs to BPL households in highly endemic areas is inadequate. Bed-nets are used only by those who realize their benefits and can afford to buy them. Tribal people, especially the poor, are yet to understand the benefits of bed-nets in the absence of a sustained information campaign. Health care personnel are uncertain that even free bed-nets will be used. The demand for free or subsidized ITNs to BPL households in highly endemic areas should be met and coupled with promotional activities involving PRIs, Tribal Councils, NGOs, CBOs and/or volunteers in communicating the benefits. APL families should also be encouraged to use nets.

• The importance of biological control using larvivorous fish is being understood increasingly. However, tribal communities expect the initiative to be program-driven with support from the Fisheries Department. PHCs should map water sources and implement biological control measures, possibly as a planned seasonal activity.

• Verification of IRS and of the distribution of ITNs/LLINs could be undertaken fortnightly by Village Health and Sanitation Committees.

Community Mobilization • Behavior Change Communication (BCC) or even Information, Education and

Communication (IEC) activities are yet to be optimally implemented. BCC/IEC strategies and activities should take into account the social and cultural background of tribal communities to ensure effectiveness. NGOs could be involved in collecting local information, providing BCC (in local languages, using folk media, etc.), and mobilizing communities and community leaders, school teachers and volunteers should be involved in BCC activities.

• Community participation in the program is weak. The constitution of VHSCs and

engagement of women from the villages as ASHAs are positive steps in involving communities. They will be trusted while mobilizing their people and supporting village health planning and action. However, the burden of work on ASHAs needs to be reviewed and rationalized from time to time for effective implementation. The necessary tasks could be redistributed among health workers and others at the village level. ANMs and other departments’ village workers (e.g., AWWs) should support ASHAs, and ANMs should be

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involved in village planning to enhance community participation. These and other grassroots workers need to be trained in community interaction, and local NGOs or CBOs should also be involved in community mobilization. Inclusion of community-based groups, community leaders and NGOs in consultations will help improve participation in the program.

E. Framework for Consultations with Vulnerable Communities during Project

Implementation The framework for consultations with tribal people and other vulnerable communities in the project areas during project implementation is presented in Table 2. It indicates the, the possible facilitators at different levels, methods they could use and frequency of consultation. These consultations are expected to give ‘real time’, experience-based feedback from clients, local leaders, staff and NGOs on how the project is functioning in tribal areas and/or for vulnerable communities, including suggestions for improvement of any aspect of the program. They will also contribute to the design and implementation of BCC efforts, operational pilots, and NGO involvement, to help ensure need- and demand-based, culturally-acceptable approaches, plans and service delivery.

Table 2. Framework for Consultations with Vulnerable Communities during Project

Implementation.

Consultation Facilitator Methods Frequency Village level VHSC/ASHA/FTD with NGO Community meeting and

key client visits Once in six months

Sub-Centre and APHC

MTS/MO-PHC with NGO Staff meeting, community meeting, and key client visits

Once in six months

BPHC and CHC

District VBD Officer/Consultant/Social Development Professional

Meeting with staff, Panchayats, key client visits

Once in six months

District District VBD Officer/Consultant/Social Development Professional and BCC Consultants

Workshop with key stake- holders (incl. tribal reps, staff, clients, NGOs, PRIs)

Annually

State State Program Officer, State Social Development and BCC Consultants

Workshop with key stakeholders (as above)

Annually

National National Program Officer National Social Devpt. and BCC Consultants

Workshop with key stakeholders (as above)

Annually

F. Action Plan As most of the project areas (“high prevalence areas”) are tribal or backward, and many of its intended beneficiaries are tribal or other vulnerable people, its intervention strategies are designed to address the constraints faced in these areas and by these people in prevention, diagnosis and treatment of malaria and/or kala-azar. The strategies include supply-side improvements; increasing access according to need; communication for demand-generation, informed decision-making and improved practices; socio-culturally appropriate and gender-sensitive planning and implementation; and monitoring by dedicated VBD experts and Social

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Development specialists.57 Table 3 shows those activities in the project that will ensure that vulnerable communities receive maximum benefits and that VBDs are reduced among them in the form of a ‘step-by-step’ Action Plan. As a guide to implementation, it shows the action, where it will primarily take place, the persons who will be chiefly responsible for its implementation, and a likely timing or frequency of action. Thus, the ‘Vulnerable Communities’ Plan’ (VCP) is integral to the Project’s overall implementation, and is part of the GOI’s Project Implementation Plan (PIP) and forthcoming Operational Manual. It will be implemented in all project districts in keeping with the Project’s planned phasing, as needed and feasible. The VCP will also guide IDA project supervision, and includes the indicators that will be used when feasible to assess implementation effectiveness for vulnerable communities. Data providing information on project outputs and outcomes for tribal and other vulnerable groups (including women and children) will be generated initially from routine program monitoring, project reports and surveys. Over time better data are expected to become available from a strengthened Health Management Information System (HMIS). When disaggregated by age, sex, SC/ST/General population, and Tribal/Non-tribal areas they will provide information on the equity being achieved by the Project, and facilitate remedial responses where necessary. G. Institutional Arrangements and Capacity Building for Implementation of the Action

Plan The institutional arrangements for implementation of the Vulnerable Communities’ Plan are given below.

Table 3. Actions for Vulnerable Communities that are Integral to Project

Action to be Taken (is also Process Indicator)

At what Level

By Whom (Implementer)

Time point/ Frequency

Output/Outcome Indicator

Component 1: Improving Access and Use of Malaria Prevention and Control Services

Sub-component 1A: Improving Malaria Case Management

1. Case detection and treatment

Mapping high risk tribal/non-tribal areas

with/without providers of RDT diagnosis

and treatment services

District DVBDO Annually

Calculating need for RDT, ACT and no

stock out/expiry for high-risk tribal areas

District w

CHC/PHC

DVBDO, DMO,

MOs

Quarterly

Mobilizing village health workers and

MPWs for case detection with RDT

Village, SC DVBDO, MTS Annually

Case detection with RDT Village MPW, MTS Continuous

Case treatment with ACT Village and

health facilities

VHW, MPW,

MO(a)

Continuous

Percent of Pf+ cases

treated with ACT

in 24 hrs (excl. first

trimester pregnant

women) (disag. by

M/F, age, SC/ST/

Genl and Tribal/

Non-tribal areas).

Initially from

surveys, then MIS

57. The consultations at the client and sub-district levels of the health system will focus on whether the program is reaching vulnerable groups, and cover all aspects of service delivery related to this project, including the cultural acceptability of interventions, BCC activities and grievance redressal mechanisms. In kala-azar areas they will also include discussions of the village environment, hygiene in homes, cattle-sheds, etc. At district level and above, the consultations will focus on whether tribal people and the most backward areas are receiving due attention in all aspects of program planning, management and implementation, including capacity-building and monitoring of private providers; and monitoring by Panchayats. Any issues arising will be investigated and addressed, and ‘Action Taken Reports’ presented at the next consulta

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2. Arranging referral to avert deaths

Identifying/mapping referral centers (RC)

in tribal and other backward areas

District DVBDO, DMO Annually

Equipping RCs with necessary anti-

malarials, supportive drugs, supplies

District DVBDO, DMO,

MO

Twice

annually

Mobilizing VHWs, MPWs, MOs for

identification of severe cases

District, Block DVBDO, MO,

MTS

Annually

Arranging referral of severe cases to RCs

in tribal areas

Village, SC,

PHC

VHW, MPW,

MTS

Continuous

Orienting RC staff to manage severe cases Block, District DMO, MO Annually

Trained staff managing severe malaria RC DMO, MO Continuous

Number of cases

and deaths

(disaggregated by

M/F, age, SC/ST/

General and

Tribal/Non-tribal

areas) when

available from

sentinel surveil-

lance data

Sub-component 1B: Strengthening malaria surveillance

1. Active case detection (ACD)

Ensuring staff in position at health

facilities in tribal areas

State, District SPO, DVBDO,

DMO

At start and

continuous

ACD of Pf+ cases in tribal areas with RDTs SC, Village MPW, VHW Continuous

Compiling and transmitting reports upto

district for analysis and feedback

SC, PHC,

CHC, DH

SC, PHC, CHC,

DHS, DVBDO

Monthly

Number of cases

detected by ACD

(disaggregated as

above). From

surveys and HMIS

2. Passive case detection (PCD) and Sentinel surveillance

Identifying and equipping Sentinel Sites

(SS) in tribal areas

State, District SPO, DVBDO Year 1, 3, 5

Ensuring staff at SS in tribal areas State, District,

SS

SPO, DVBDO,

DMO, SS-in chge

At start and

continuous

Passive case detection Hlth facilities MPW, MO Continuous

Compiling and transmitting reports up to

District for analysis and feedback

Hlth facils., SS

and District

MTS, MO, SS-in-

charge, DVBDO

Monthly

Number of cases

detected by PCD

(disaggregated as

above). From

sentinel surveil-

lance data.

3. Rapid response

Setting up response teams in tribal areas State, District SPO, DVBDO At start

Identifying outbreaks in tribal areas,

reporting, working with IDSP

Hlth facility,

SS and District

MTS, MO,

DVBDO

Continuous

Investigating outbreak; following up Village, Block DVBDO, SS,MTS Continuous

Percent of Tribal/

Non-tribal districts

with active

response teams

Sub-component 1C: Effective vector control

1. Indoor Residual Spraying

Identifying high risk tribal areas District SPO, DVBDO Annually

Supplying insecticide and equipment PHC SPO, DVBDO Annually

Storing insecticides safely PHC MO, MTS Annually

Orienting spray teams to safety, quality PHC DVBDO Prior to IRS

Organizing BCC and involving

community

Village MTS, BCC cons. Prior to IRS

Conducting spraying with concurrent and

post quality assessments

Village Teams, MTS,

DVBDO

Per schedule

Percent of houses

targeted for IRS

that received full,

quality spraying in

each round (disag.

by Tribal/Non-T

areas); from

program reports,

then MIS

2. Use of Long Lasting Insecticide Treated Bed Nets (LLINs)

Identifying tribal villages for full coverage Village DVBDO, MTS Annually

Inviting CBOs/PRIs/Tribal Councils, etc. to

participate in storage and distribution

Village MTS, MPW, MO Annually

Supplying LLINs and storing safely prior

to distribution

District,Village NPO,SPO,DVBD,

MTS, local group

Annually

Percent of LLINs

delivered to people

of those planned

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Distributing LLINs and monitoring

proper use

Village MTS, MPW, local

group

Annually by the district

(disag. by Tribal/

Non-T areas); from

reports, then MIS

Component 2: Supporting Elimination of Kala-azar

Sub-component 2A: Improving KA Case Management

Mapping high risk areas District, Block SPO, DVBDO Annually

Calculating need for RDT (Rapid Diagnostic Test for Kala azar), and ensure no stock out/expiry

District, Block NPO, SPO, DVBDO, MO

Quarterly

Mobilizing MPWs for case detection Village, SC KTS, MO Annually

Case detection with RDT Village, SC MPWs Continuous

Completing treatment (new/standard), treatment cards, provision of food support for patient/attendant

PHC, SC MO, KTS, MPW Continuous

Percent diagnosed Kala-azar patients completing new/ standard treatment (disag. by M/F, age, SC/ST/ Genl, and Tribal/Non-T areas); reports, and gradually HMIS

Sub-component 2B: Strengthening Kala-azar surveillance

1. Active Case Detection

Identifying areas for active case search District, Block SPO, DVBDO, MO and others

Twice a year

Mobilizing and orienting health teams Block, Village KTS, MPW Twice a year Maintaining case register; compiling reports and transmitting up to District for analysis and feedback

Village, Health facilities

Health teams, KTS, MO

Monthly

Number of cases detected through ACD (disag. by M/F, age,SC/ST/G, T/NonT areas); surveillance data

2. Passive case detection (PCD) and Sentinel surveillance

Identifying, staffing and equipping Sentinel sites

District SPO, DVBDO Years 1, 3, 5

PCD (standard method) and case treatment

Sentinel sites SS in charge As needed

Compiling reports and transmitting up to District for analysis and feedback.

Sentinel sites, District

SS in charge, DVBDO

Monthly

Number of cases detected by PCD (disag. by M/F, age, SC/ST/Genl and Tribal/Non-T areas); reports, then surveillance data

Sub-component 2C: Effective vector control (Indoor Residual Spraying)

Identifying high risk areas District, Block SPO, DVBDO Annually

Supplying and storing DDT, equipment Block NPO, SPO, DVBDO, KTS

Annually

Orienting teams in safe, quality spraying Block DVBDO, KTS Prior to IRS Organizing BCC and involving community

Village BCCCons, KTS Prior to IRS

Conducting spraying with concurrent and post quality assessments

Village Teams, KTS, DVBDO

Per schedule

Percent of houses targeted for IRS received complete quality spray in each planned round (disag. by T/Non-T areas); reports

Component 3: Policy and Strategy Development, Capacity Building and Monitoring and Evaluation Sub-component 3A: Policy and strategy development

Conduct workshops to identify pilots to assess operational feasibility and impact of approaches to improve services for vulnerable groups (at least 2 each for Malaria, KA) and prepare TORs

National N SD Prof. with NIMR, other research institutes, medical colleges, NGOs, etc.

Years 1, 3

Contract pilots (with TORs) National N SD Profsnl. Years 1, 3

Conduct pilots; provide reports Per TORs Consultants Per schedule Take follow-up action as recommended Per Recoms. NPO, SPO Year 3 on

Number of studies identified, designed and conducted for Malaria, Kala-azar; from project reports

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Sub-component 3B: Program management and capacity building

1. Program management: Position

national and state Social Development

Professionals; form and orient multidisci-

plinary team (anthropology, communica-

tions, public health) at national level

National, State NPO and SPOs At start of project and sustained throughout

Staff in position

2. Engage NGOs for Service Delivery and Social Mobilization

Developing appropriate TORs and engage NGOs to work in states

National NPO and SD Prof. with states

Year 1 and as needed

Develop plans and implement activities Villages NGOs Per Plans

Obtain lower level feedback, review and revise plans, and plan expansion

National, State N+S SD Profs, NGOs

Year 2 onwards

Number of villages covered by NGO activities (disag. by T/NonT areas); project reports

3. BCC for Malaria control and KA elimination

Developing TORs and engage BCC

Consultant agencies for project: 1 per state

National NPO, BCC and

SD Specialists

At start of

project

Doing assessments, develop strategy and

plans for BCC activities per TORs

All levels BCC Agency and

others as needed

Per TORs

Implementing activities according to plans

All levels BCC Agency + others per plans

Per Plans

Obtaining lower level feedback, reviewing, revising, planning expansion

National, State N+S BCC + SD Profs, Agency

Year 2 onwards

Percent of indivi-

duals/HH who

- slept under ITNs,

- allowed full IRS

- sought DandT in

24 hrs of fever

(disag for Tribal/

Non-T areas);

survey data

4. Training in VCP and Sensitization Engaging Training consultant agency/ies National NPO and SD

Prof. with states Year 1 and as needed

Assessing special training needs to ensure culturally appropriate efforts for tribal people and women, developing and carrying out training

As needed Training agencies

Per schedule (prior to transmission season)

Evaluating training (incl. quality, using suitable indicators); following up

As needed NPO, SPO, SD Profs, DVBDO

Annually

Percent of staff trained at each level of those estimated to require specific training (disag. by T/Non-T areas); project reports

Sub-component 3C: Monitoring and Evaluation Examining Routine Program Monitoring reports from Tribal/Non-tribal areas

District and above

M&E Officers, SPO, NPO

From start Analysis differen- tiating these areas

Using GIS to map high-risk areas, health facilities, and other issues in tribal areas

District, State NPO,SPO, M&E Officers, Conslts

Per agreed schedule

Availability of relevant maps

Developing HMIS to generate data disag. by M/F, SC/ST/G, and T/NonT areas

All levels NPO,SPO, M&E Officers, Conslts

Per agreed schedule

Availability of disaggregated data

Population-based LQAS survey PHC NPO,SPO, M&E Officers, Conslts

Annual Availability of disaggregated data

Cross-sectional household surveys (mid-term and endline)

Village NPO, M&E Officer, Conslts.

Year 2, 5 (2010, 2013)

Availability of disaggregated data

Note: (a) “MO” includes CHC MOs, BPHC MOs, PHC MOs and APHC MOs as relevant. National Level: As the Borrower is the GOI, responsibility for overseeing implementation of the Action Plan will lie with the national Directorate of NVBDCP in the MOHFW. The Directorate will engage a full-time Social Development (SD) professional with a social science background to provide technical assistance and monitor the VCP. S/he will coordinate with State Program Officers, state-level SD professionals, and partner organizations. For efficient and effective implementation of the activities in the Plan, other program officers and professionals responsible for BCC, Training, M&E, etc. will also be consulted as needed.

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State Level: The state NVBDCP Manager will be primarily responsible for the program and the VCP which is an integral part of it. A full-time Social Development professional will provide technical assistance and monitor the VCP. S/he will coordinate with the national level and provide support to the District VBD Officers and consultants. As above, program officers and consultants responsible for BCC, Training, M&E, etc. will be consulted as needed. District Level: In all VBD endemic districts, the Project will primarily be the responsibility of the District VBD Officer. An additional program manager will be appointed at district level to increase managerial effectiveness, and three Integrated Vector Management Supervisors to improve quality and effectiveness of vector control operations. The VCP will be implemented by the District VBD Officer with the support of the District VBD Consultant. This team will coordinate with the sub-district levels, and report on progress, constraints and resource requirements to the state team. Capacity Enhancement. The NVBDCP has an on-going training program to enhance the capacities of health workers and technical personnel at all levels. To build the knowledge and skills to implement and manage the VCP, the curriculum and modules will be expanded to include topics such as: socio-cultural (including gender) issues; the political and self-governance structures of vulnerable communities, their rights and policies; methods to assess and address their needs and priorities; approaches to achieve and sustain vulnerable communities’ access to VBD control services and products; and so on. Social mobilization, counseling and motivation skills will be stressed. Training on the VCP will be integrated into the overall NVBDCP training. Reorientation will be carried out after assessment of capacities during project reviews. A database of experts with social science backgrounds and knowledge of tribal people and other vulnerable communities will be developed to ensure the availability of appropriate trainers and technical resources. H. Measures to Address Potential Adverse Effects The Vulnerable Communities’ Plan will address any unintended or unforeseen effects of the Project that may increase peoples’ vulnerability to VBDs or its control operations. The potential adverse impacts could be related to vector management or case management and include insecticide resistance, drug resistance, poor health and environmental contamination caused by improper use, handling, storage, etc. of treatment agents. The program includes several activities to reduce these risks such as integrated vector management and case management, which are described in Annex 4: Detailed Project Description and in the Environment Management Plan below. In addition, micro-planning of all interventions will be undertaken at the district level to ensure that local needs are addressed appropriately. Health volunteers, PRIs, Tribal Councils and other CBOs will be sensitized, participate in planning and implementation, and take responsibility for monitoring vector control, treatment interventions and effects. BCC activities will be targeted to make the affected and surrounding communities aware of the causes and methods of VBD prevention, diagnosis and treatment options, and to stimulate appropriate behavioural responses. The BCC will also build in information on the potential adverse consequences of use, non-use and improper use of drugs and insecticides. Capacity building, supervision and monitoring

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activities planned under Project will also help to avoid, minimize, mitigate or compensate for adverse effects. A situation analysis of kala azar will be carried out at the commencement of the project to identify additional interventions that could be undertaken in the project or in other government programs to address the disease and its underlying causes. Similarly, studies to assess operational needs to address the disease burden of tribal and other vulnerable populations will be conducted during the project to strengthen program strategies. I. Activities, responsibilities, timeframe and costs for Vulnerable Communities’ Plan (VCP)

A focus on vulnerable communities is an integral part of the Project and its key activities were indicated in the Action Plan above. As such, the costs of most activities for vulnerable groups are included in the costs for the population at large. However, to ensure the effective provision of services to vulnerable groups some special efforts will be made to focus the attention of program managers; support action by the health system; facilitate community consultations, action, and oversight; and pilot innovative approaches to vulnerable groups. Table 4 summarizes these provisions, including cost estimates. Table 4. Special Activities for Vulnerable Communities, Responsibility, Time-frame and Estimated

Costs Action Responsibility By When Cost (INR)

Salaries for staff dedicated to supporting preparation and implementation of VCP (National and State SD Professionals)

NVBDCP and State Directorates

From start of project and sustained throughout

20,000,000

Development of training modules for preparation and management of VCP, and of booklets to sensitize existing community institutions (e.g., VHSCs)

NVBDCP with consultant agency

Within three months of project start

2,000,000

Sensitization workshops for VHSCs, PRIs, RKSs and State and District Health Societies

District VBD Officers and SPOs

Once every two years (Year 1, 3, 5)

40,000,000 (a)

Conducting/facilitating and preparing summaries of periodic consultations, including annual district, state and national summaries

NVBDCP and consultant agency/ies

As shown in Table 2

5,500,000

Engaging NGOs in tribal and other difficult areas for social mobilization and special activities focused on vulnerable communities

National with State According to need

Upto 70,000,000

Workshops and consultations to design pilots to assess operational feasibility and impacts of innovative approaches to improve services for vulnerable people

NVBDCP working with NIMR and IDA

Early in Years 1and 3

Implementation of pilots and assessing their impacts (at least 2 each for Malaria and Kala-azar)

NVBDCP and consultant agency/ies

Years 1 to 4

Up to 50,000,000

Note: (a) Estimated on the basis of Rs. 10,000 per Block plus Rs. 25,000 per District

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J. Grievance Redressal Procedures In India, poor rural and tribal areas are disadvantaged in terms of access to quality health care on account of their remoteness, difficult terrain, weak infrastructure including health facilities, inadequate service providers, and so on. Furthermore, the social, cultural and economic characteristics of tribal and other vulnerable communities, coupled with social exclusion even of their leaders, and deficient health promotion and outreach activities, contribute to gross under-utilization even of available services. In view of the specific needs of such areas, the Project will establish systems to bring out and redress grievances related to the lack of access to or availability of curative and preventive VBD services and information. Within the health system, cases and outbreaks, stock-outs of drugs, backlogs of unexamined blood slides, unavailability of bed-nets, poor coverage and quality of insecticide spraying, inadequate biological control, inadequate/ineffective BCC/IEC activities, and so on, will be reported upward from village to sub-district, district, state and national levels. In addition to this internal monitoring and reporting, individuals, community volunteers (such as ASHAs, FTDs, AWWs), local self-government (VHSCs/PRIs/Tribal Councils), NGOs/CBOs, the autonomous societies managing health facilities (Rogi Kalyan Samitis, RKS), and District and State Societies will be able to express their grievances through a variety of means. Tribal and other vulnerable community representatives will be included in stakeholder committees to recognize and address issues. Contact information for core program/project staff (such as telephone/mobile phone numbers and addresses for postcards/written communication) will be provided at the community level. No less than annual review meetings will be held with stakeholders at community, block and district levels. The Project will give wide publicity to inform vulnerable communities and others about all grievance redressal procedures. K. Mechanisms and Benchmarks for M&E and Reporting Specific performance indicators to monitor the Vulnerable Communities’ Plan were given above. The mechanisms available to monitor the Plan are described below. � At the start, mid-term and end of the project, cross-sectional household surveys will provide

information on individuals disaggregated by age, sex, and SC/ST/General categories and at the household and community levels. The baseline survey has been completed, and mid-term and end-line surveys will be carried out in 2010 and 2013 (Years 2 and 5), respectively, by an independent agency. The surveys will include participatory methods and approaches to provide a comprehensive picture of service delivery to, acceptance of interventions by, and accrual of project benefits to the vulnerable communities.

� Rapid Population-based Surveys using the ‘lot quality assurance sampling’ method (LQAS) will be undertaken annually in each project district to track coverage and use of RDTs, ACT, LLINs (for malaria), Rapid Diagnostic Test for Kala azar, medicines and treatment completion (for KA), and IRS (for both diseases). Information will be available at the PHC level, and will be fine-tuned over time, to provide estimates for outcome indicators at the district and overall project levels. It is expected that these data will be examined by area and possibly by community or household characteristics.

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� Routine Program Monitoring. At the state and district levels, service-related data collected regularly provide information about program inputs (e.g., staff, supplies and financial resources), processes (e.g., training, communications) and outputs (services delivered). Over time this routine information provides a picture of increases or decreases, improvements or gaps, achievement of stability, and so on. Data for tribal districts/areas will be examined separately.

� Geographic Information System (GIS). The Project will facilitate GOI’s efforts to introduce GIS to map high-risk areas and health facilities, monitor the distribution of VBDs in tribal areas, analyze time trends, ensure available health resources, and forecast epidemics. GIS data (in the form of maps) will also help to plan appropriate actions at the local level, for example, to identify high-risk areas for IRS. The availability and use of ‘tribal maps’ will be examined during IDA reviews.

• Health Management Information System (HMIS). The Project will support revamping of the VBD MIS, and enable monitoring of the use of services by vulnerable groups and women, and timely and appropriate responses by the health system. Data is expected to be disaggregated by M/F, age, SC/ST/General, and Tribal/Non-tribal area by the early implementation review.

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L. Environment Management The Environmental Management Plan (EMP), prepared by the Directorate, consists of a set of mitigation, monitoring, capacity development and institutional measures to be taken during implementation and operation of the project, to address the adverse environmental and social impacts, offset them, or reduce them to acceptable levels. The EMP also includes an implementation schedule and the capital and recurrent cost estimates for its implementation. This budget estimated for the EMP will be integrated into the total project cost. This Annex summarizes the Action Plan and Recommended activities which are detailed in the EMP. Legal Framework: NVBDCP, through this project needs to recommend and support the GOI in updating the various regulations related to its activities. The key activities include review of compliance of Insecticides Act to meet minimum essential international standards. Also the EMP recommends revision of the national guidelines (based on FAO’s Pesticides Guidelines on Storage, Labeling, and Disposal), to include monitoring, efficacy evaluation for the registration of plant protection products; and compliance and enforcement of a pesticide regulatory program. Procurement: Pesticide procurement is highly specialized and complex due to time-lag of delivery between production and usage. While the NVDCP will utilize the services of UNOPS as a procurement agent, the real challenge still remains in effective implementation of the program on the ground ensuring that quality services reach the most needy populations in time and appropriate pesticide management practices are followed. The EMP recommends a number of activities such as modification of specifications/contracts with insecticide producers to include guidelines for pesticide application and disposal of used bags/containers, measures for quality control and adequate labeling of products, including translation in local language of destination. The manufacturers should include instruction leaflets in local languages before dispatching the goods to destination. This will be one of the pre conditions in bidding document. Pre and post dispatch certification is necessary for all insecticide based products. Materials and quality of packaging by insecticide manufacturers shall be reviewed periodically by NVBDCP to ensure efficacy, shelf-life, human and environmental safety and manufacturers should provide independent certification of chemical and physical analysis, product and formulation acceptability to NVBDCP. The NVBDCP has instructed all insecticide producers to provide protective gear along with their products Storage and Transport: Due to poor storage and conditions currently existing in the states, the EMP recommends that funds be allocated from the program for construction and/or up-gradation of appropriate storage areas for district HQ and PHC facilities. Training needs to be provided in proper stacking and utilization is essential for minimizing damages, leakages and accumulation of stocks. Safe transportation of insecticides requires trained drivers, well-labeled vehicles, checking of quality of packaging and pesticide load during transit and at point of delivery. The NVBDCP has requested HIL to changeover DDT packaging from gunny bags to fibre-board drums to reduce ruptures, spills and also loss of efficacy during storage. Licensing of insecticide manufacturers, distributors, retailers, and pest control operators is an important aspect of

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pesticide management. Annual procurement and distribution cycles between states and the Directorate need to be synchronized to allow timely delivery and usage prevent stockpiling. States should also provide information on amount of stockpiled insecticides in larger storage areas particularly at district and PHC levels. A systematic tracking system of volumes of insecticide from factory to point of delivery needs to be established by the manufacturers, along with a system for reporting spills and leakages during transit. NVBDCP should include this requirement in their contracts to be monitored by the consignee state governments. Application Activities: Safe and environmentally sound application of insecticides (space spraying and IRS, impregnation of bed-nets, larviciding, etc.) can be achieved by intensive training of all the spray workers and handlers and by timely availability of protective gear. Equipment management is important and states have to review all spray equipment and protective gear before start of each spraying season and keep appropriate records. Close supervision of application activities is essential and district and PHC level officials should be provided adequate funds and training to ensure good practices are being followed. Manufacturers are stipulated to provide instructions for disposal of pesticide containers including plastic wrappings and one way of reducing wastage is by provision of appropriately sized packages for spraying and impregnation activities. Funds should be allocated to develop clear pictorial instructions to health and spray workers on use, applications, preparation of suspension and disposal of insecticides, insecticide treated materials, insecticide containers etc. Integrated Vector Management: The EMP Action Plan recommends that IVM activities will be piloted in three districts (malaria and Kala azar) during first year of the project. The NVBDCP will develop a phase-down plan for gradual decrease in DDT use and promotion of ITMN, biolarvicides and IGR compounds. This plan will be shared with IDA. Other activities include mapping of insecticide resistance status of malaria vectors and training staff in effective IVM procedures. Waste Management: Since the Ministry of Health and Environment, through its various programs, has developed a number of detailed guidelines for implementation of sound infection control and waste management practices, which the VBDCP can utilize effectively. NVBDCP shall replicate standard protocols for waste management during the first year of the project. This will be developed by the Consultant (Environment). NVBDCP will ensure that these protocols are disseminated to the states and training is provided to its field staff. Occupational Health and Safety: The EMP proposes that a National Surveillance Committee be constituted to review health and environmental impacts of vector control activities, which can review issues related to worker health and safety and recommend solutions which are applicable and feasible in Indian conditions. Such committees at national, state and district level will conduct periodic review on occupational health safety measures every year during malaria and other VBD transmission season. State and district has one such Task Force committee chaired by Secretary (health) at state level and District Collector at district level for observance of anti malaria month. The same members will monitor the safety measures at state and district level.

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State and district shall ensure that the recommendation of committee is followed at all level of the program implementation. The NVBDCP will strengthen liaison with the Ministry of Agriculture for quality control and stocks management of pesticides. The EMP also recommends that the NVBDCP commission an independent audit for impact of vector control activities after 2 years of project implementation. Capacity Building: Capacity building for good worker practices is an integral and essential part of integrated vector management. This activity will include provision of rigorous and regular training for different levels and types of workers and certification of staff and operators in the following activities: stock management; good storage practices; proper handling of pesticides during transport and disposal; application of insecticides; surveillance methods; signs and symptoms of poisoning, emergency measures; PPE usage; accident reporting, data management and monitoring and reporting. Such capacity building should target those involved in the production, distribution, use and application of insecticides, householders and health personnel. The VBDCP will hire an OEHS expert for development of different guidelines on environmental safeguard policies and waste management. BCC /IEC: Long-term health education and communication approaches are required to educate the community, create general awareness and provide accurate information to elicit support for sound and effective use of insecticides. Such approaches are absolutely vital for field level activities such as spraying and bed-net impregnation. A village level committee comprising of the village chief, Anganwadi worker/ANM, junior health worker and village teacher could be constituted to supervise the proper storage, spraying, environment management including disposal of used containers etc at sub centre/village. Community should also be educated to understand the importance of IRS and to take necessary steps to ensure maximum efficacy of spraying. Domestic and peri-domestic sanitation may be an important component where individual and community cooperation is essential. The NVBDCP develop new guidelines on sound environmental and OHS issues will be developed and disseminated actively across all states. An Action plan will be developed before commencement of new project by the OEHS expert. Additionally NVBDCP shall utilize GOI’s guidelines on Intersectoral collaboration and modify them in the context of this program, to ensure IVM activities are successfully implemented. Institutional Framework: For effective implementation of the EMP, the GOI and NVBDCP have decided to strengthen the institutional framework at national and state levels. An Environment Consultant at the national level, one entomologist at district levels and Malaria Technical Supervisors at block level are to be newly recruited. The Accredited Social Health Activist (ASHA) under NRHM at village level is also being envisaged for supporting the implementation of the EMP. To monitor the surveillance outbreak and support the EMP activities, one multi purpose health worker per 5000 population will be assigned at sub center levels. The Consultant (Environment) will not only provide technical guidance, supervision but also monitor the state level activities with regard to the EMP.

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All agreed actions defined will be appropriately reflected in the VBDCP PIP, project budget, legal agreements and contractual documents. The NVBDCP will also hire an OEHS expert to review the occupational health and safety measure being implemented under the project. Reporting and Monitoring: While it is recognized that data and information collection in such a decentralized program is quite difficult, but without effective monitoring of the insecticide chain and environmental and health issues, such a program can not be successfully implemented. The EMP recommends that the existing data management system be strengthened considerably and include all levels of the insecticide chain – manufacturer, distributor village, primary, district, and state offices. The reporting system will include the following: tracking of insecticide movement from production to disposal, records of insecticides utilized in various applications (IRS, spraying and larviciding), records of ITN procured, distributed and impregnated, amounts of insecticides used for impregnation monitoring of spray workers, records of spray equipment, PPE and other tools related to insecticide use, conditions of storage and transportation, records of accidental poisoning etc. The state level surveillance committee should review the above records on an annual basis and recommend corrective measures where necessary. The National Committee should review the findings and recommendations of the state level committees Implementation: Given the scope of the program and the complexity of the environmental and health issues related to insecticide use and IVM practices, it has been agreed between the GOI, NVBDCP and IDA that the EMP will be implemented in different phases. The first phase will be a pilot phase for about 18 months and will focus on three districts (both malaria and KA). The lessons learnt from this “pilot” phase will be reviewed after 18 months and then replicated in the remaining project sites, as appropriate. The timing, frequency and duration of mitigation measures and monitoring for the first 18 months are given in Table 7. The table also includes cost estimates for both the initial investment and recurring expenses for implementing all measures defined in the EMP, integrated into the total project costs and factored into loan negotiations.

Table 7. Action plan for EMP Implementation

Action Responsibility By When Cost (Rs) Contracting of consultant agency for supporting the NVBCP in development and implementation of EMP

NVBDCP April 2009 3,000,000

Review the existing legal framework including municipal bye-laws and international guidelines

NVBDCP (through consultant agency)

April 2009 2,000,000

Provision of PPE and pictorial instruction leaflets in local language in individual insecticide packages procured under the project

NVBDCP and Procurement Agent

Initiate in Sept 2008 and continue to end of project

Survey of current storage and disposal NVBDCP through April 2009 1,500,000

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practices of insecticides in year I states and preparation of action plan to improve storage and disposal practices

NIMR

Survey of stockpiled insecticides in larger storage areas and development of plan of action for disposal of these stockpiles, in consultation with IDA

NVBDCP through NIMR (survey) and States (Action Plans)

December 2009

Piloting of EMP activities in 3 districts covered in first year of the project

NVBDCP through NIMR

Sept 2008 – Aug 2009

2,500,000

Organizing workshops and meeting to update the national guidelines for all aspects of insecticide management (procurement, storage, use, disposal, OHS, monitoring, quality assurance and inter-sectoral coordination)

NVBDCP though the Consultant Agency

October 2008 1,500,000

Workshop for training of Trainers in the application of new national guidelines

NVBDCP November 2008 500,000

Preparation of training Plan, Training modules and facilitator guidelines

NVBDCP through engaging a consultant

Nov-December 2008

500,000

Implementation of decentralized training activities at state and district levels (with completion before spraying season)

State and district Vector Borne Diseases Control Officers

Jan-Feb 2009 and subsequent years

25,000 per district

Development of TOR and establishment of National Surveillance Committee

NVBDCP June 2008- Nov 2008

Independent audit of impact of EMP NVBDCP EIR Plan for DDT usage NVBDCP Annual Replication and dissemination of Waste Management protocols

NVBDCP October 2008

Development of monitoring framework and monitoring the implementation of EMP

NIMR October 2008 (framework) and subsequent monitoring acc. to plan

2,000,000

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Annex 12A: Project Preparation

Planned Actual Project Concept Note review 07/08/2005 07/07/2005 Updated PID to Infoshop 03/10/2006 10/24/2007 Initial ISDS to PIC 03/10/2006 10/24/2007 Appraisal 03/20/2006 06/02/2008 Negotiations 06/20/2006 06/09/2008 Board/RVP approval 07/31/2008 Planned date of effectiveness 08/15/2008 Planned date of mid-term review 02/01/2011 Planned closing date 12/31/2013 Project preparation has been done by IDA with the support of WHO. IDA staff and consultants who worked on the project include: Name Title Unit Peter Berman Lead Economist/Task Team Leader SASHD G.N.V. Ramana Lead Public Health Specialist/Task Team Leader SASHD J.S. Kang Senior Public Health Specialist/Task Team Leader SASHD Rajeev Ahuja Health Economist SASHD Jed Friedman Economist DECRG Philip Beauregard Senior Counsel LEGMS Meera Chatterjee Senior Social Development Specialist SASES Ruma Tavorath Environment Specialist SASES Shanker Lal Procurement Specialist SARPS Mohan Gopalakrishnan Senior Financial Management Specialist SARFM Arun Manuja Financial Management Specialist SARFM Neera Bhatia Team Assistant SASHD Joseph J. Valadez Senior Monitoring and Evaluation Specialist AFTHD Allan Schapiro Consultant SASHD Vijay Kumar Consultant SASHD Sridhar Srikantiah Consultant SASHD R. Balasubramaniam Consultant SASHD Hema Vishwanathan Consultant SASHD Basav Raj Consultant SASHD Sumeet Bhatti Consultant SASHD Birte Holm Sorensen Consultant SASHD

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Staff from WHO who worked on the project included: Name Title Unit Sergio Spinaci Associate Director, Global Malaria Programme WHO/Geneva Prasittisuk Chusak Coordinator, Communicable Diseases Control WHO/SEAROT. Krongthong Regional Advisor, Malaria WHO/SEAROKamini Mendis Senior Advisor, Malaria WHO/Geneva Richard Cibulski S. Monitoring and Evaluation Specialist WHO/Geneva A. Gunashekhar National Professional Officer WHO/India

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Annex 12B: Enhanced Implementation Support

A. Background The Project will enhance Government of India’s efforts to control malaria in high burden districts from eight states and eliminate kala-azar from highly endemic districts in three states. The project is expected to contribute to poverty reduction and to achieving the Millennium Development Goals (MDGs). IDA has supported an earlier operation for control of malaria which closed in December 2005. This closed project is one of the 5 included under the Detailed Implementation Review (DIR) undertaken by IDA. The supervision strategy is based on the lessons from the previous operation, DIR findings and comprehensive technical assessment undertaken during the project preparation in collaboration with the WHO. Based on the feedback from the Quality Enhancement Review, the project design has been significantly changed. From the original concept of supporting a nation-wide program covering all vector borne diseases, the project has now been limited to two diseases causing highest burden among the poorest covering the most endemic districts in 11 states. While this will help to improve the oversight, the project will still remain a high-risk operation. The DIR has identified several weaknesses in decentralized procurement and indicators of collusion and weak contract management in central procurement under the earlier project. Some of the states having highest burden of malaria and kala-azar, especially the states of Chattisgarh, Jharkhand, Orissa and Bihar, have weak implementation capacities and fiduciary oversight. This poses a major challenge for the implementation of new diagnosis and treatment policy for malaria control and elimination of kala-azar. Given the weak implementation environment and experience to-date with externally assisted projects in India, close and intensive implementation support will be critical for achieving the development objectives. B. Strategy for the enhanced Implementation Support The strategy involves a combination of continues oversight and periodic more intensive implementation support and will have specific focus on three broad areas: (a) Progress in Implementation of agreed technical reforms: The scope of these reviews will include new drug policy, introduction of RDKs and LLINs. This will be done through: (i) improvements in project MIS supported by GIS mapping; (ii)validation of MIS through Lot Quality Assurance Surveys (LQAS); (iii) two rounds of household surveys out which first will be during the early implementation review; (iv) systematic monitoring of therapeutic efficacy of anti-malarial drugs and vector resistance for insecticides being used in the program; (v) monitoring the quality of pharmaceuticals and commodities procured under the project; (vi) bi-annual program technical reviews led by WHO; and (vii) impact evaluation studies. (b) Oversight for decentralized activities: This oversight covers recruitment, availability and functioning of contractual staff supported by the project and implementation of training activities as per the agreed guidelines. This will be done through: (i) semi-annual third party reviews covering 25% of districts included in the first 18 months and at least 15% of the districts during the later three years; (ii) Early implementation review of the project after 18-24 months of

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effectiveness; and (iii) Enhanced field visits during implementation support mission as well as undertaking thematic mini missions and regional reviews. (c) Implementation reviews of GAAP and Joint DIR action plan: This includes review of the progress in project specific GAAP and DIR joint action plan common for all IDA operations in India. The activities will include: (i) A six monthly update on the project specific GAAP will be prepared by the MOFHW; (ii) Quarterly reports on implementation progress of the DIR joint action plan to IDA management; and (iii) Post review of all procurements undertaken centrally which are not covered in prior review. Stakeholder and partner participation in project implementation oversight A key issue in centrally sponsored projects is the lack of ownership by the states and weak implementation at that level. While the severity of malaria and kala-azar in the selected states generates concern among the state governments, continued engagement and dialogue with states will be necessary and this will be ensured throughout the project period. In addition to the capacity building measures included in the project, the task team will regularly visit the key states and participate in state level implementation reviews. In addition to the national project launch workshop, state and district launches to create awareness among the concerned officers to ensure better understanding of the project for effective implementation, are planned as part of the supervision strategy. As was done during the project preparation, the supervision will involve active participation of key technical partner WHO as well as GFATM which is also supporting the VBD program. There will be active engagement of states and other partner agencies working in the area of VBD especially NGOs and social marketing agencies. The MOHFW has already identified some large NGOs that have strong field presence in the project states and capability to undertake stakeholder consultations as well as help the districts to prepare the decentralized plans targeting on vulnerable populations. A final decision of single sourcing such NGOs will be taken during the appraisal. The MOHFW is keen to involve the medical colleges and schools of public health in LQAS and the implementation arrangements for such involvement will also be finalized during the appraisal. The project scope includes sensitization meetings for Panchayat Raj Institutions, especially for the villages selected for LLINs to improve household behaviors. Finally, the project is a part of the NRHM and the district VBD plan will be a part of the integrated NRHM district health plan and reporting systems will be gradually integrated with that of the NRHM. Implementation Plan To ensure continuous technical support, the Task Team Leader will be based IDA’s Delhi Office supported by three short term technical experts - one international consultant for malaria (60 days) per year) and two national consultants for malaria and kala azar (60 days each per year). In addition to constant technical guidance, these experts will be supporting the task team in reviewing the technical specifications of commodities procured under the project and providing technical comments on procurement complaints. Implementation readiness criteria for project

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districts (Annex - 6) have been discussed in detail during the pre-appraisal. While the post reviews will be covering 100% of the central contracts, the decentralized activities (limited to contractual staff, training and mobility see annexes 7 and 9) will have at least semi-annual reviews carried out by external agencies hired by the GOI during the first two years. These reviews will cover a sample of the project districts to monitor the availability of staff, their performance and stock situation of crucial supplies (diagnostic kits, ACT and miltefosine) made under the project. This sample will include more than 25% of districts in the first 18 months and at least 15 % in year three to five assuming that performance is satisfactory. The sampling can be revised in case of poor performance. The report of the reviews will form the basis for district and state visits by the NVBDCP state coordinators and IDA supervision teams for enhanced implementation support during the next quarter. The MOHFW will share the guidelines for selection of contractual staff and the names of the selected candidates will be disclosed at the web site of the district health mission. Where possible, the senior staff from MOHFW and NVBDCP will also be participating in the selection of the contractual staff in states. Implementation Support during the First Year of the Project: The focus of implementation support in the first year will be on working closely with the MOHFW and project states to put in place implementation arrangements and institutions for the activities agreed under the GAAP for the VBD project. The ongoing monitoring of the joint action plan by the sector to address deficiencies identified by the DIR will also help the VBD project. The agreed district readiness criteria will be applied and the number of districts included under the project during the first year will be determined on the ability of each identified district to successfully fulfill these criteria. In addition to the national launch workshop, state-specific launch workshops and district level sensitization meetings will be undertaken to make the staff familiar with the agreed fiduciary arrangements and reporting requirements. One specific area of focus in the year 1 will be following-up on actions being undertaken by MOHFW to register more LLIN manufacturers in India and improving the supply chain logistics through hiring state level agencies. The protocols for LQAS will also be finalized and piloted during the first year. During the first year, the task team will have monthly meetings with the NVBDCP Directorate and the MOHFW focusing on these issues with a view to addressing these before they arise or become acute. Annual plans: Two full-team joint implementation support missions are proposed every year in which WHO and GFATM will be invited to participate. The missions in addition to technical specialists and an M&E expert will include the procurement, financial management, social development and environment specialists. As has been the practice in the SA region, each of these missions will have clear Terms of Reference and mission outputs such as aide-memoirs and back to office reports laying down issues, recommendations and understandings approved by the sector management followed by well-prepared Implementation Status Reports cleared by sector manager and country management team. In addition three joint external reviews led by WHO are proposed and NVBDCP will be seeking to seek WHO’s support for this. The project will support annual LQAS to validate the program reports on performance. The protocol for such surveys is described in the M&E section and LQAS will form the basis for

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annual joint project appraisal. Active engagement and participation of other development partners especially DFID and USAID currently supporting health systems strengthening initiatives in some of the malaria/kala-azar endemic project states such as Orissa, Jharkhand and Madhya Pradesh will be ensured to provide additional technical support and implementation oversight. An early implementation review will be carried out after 18 months of implementation, i.e., early 2010 with technical support from WHO to assess the project implementation in phase I districts. Project scale-up to the remaining districts will be subject to satisfactory implementation. Planned supervision activities, schedules and expected outputs are in the table below. The task team has worked in close collaboration with WHO and GFATM during the preparation and this partnership will continue during the implementation. They will provide the much needed additional technical assistance to the project. There will be additional project reviews during the regular IDA reviews with the Department of Economic Affairs. Again, based on the implementation status, the task team will request management to participate in selected missions. The table below assumes that project will become effective by August 2008 and implementation will begin from September 1, 2008. It provides an overview of supervision activities, schedules and outputs: Activity 2008/09 * 2009/10 2010/11 2011/12 2012/13 Outputs

Launch Workshop

September 2008

Workshop Report

Five State Launch Workshops

October 2008

Three Workshop Reports

Supervision Missions (2/year)

February 2009

August 2009 Feb. 2010

August 2010February 2011

August 20110February 2012

August 2012 Feb. 2013

Nine Aides-MemoireAnd 10 ISRs

Early Implementation Review

Feb. 2010 Aide-Memoire

ICR Mission

July 2013 Aide-Memoire

Surveys Baseline before Feb. 2009

First repeat survey before Feb. 2010

Second repeat survey before Feb. 2013

State/District Visits (no. of visits)

3 3 4 4 4 18 Field Visit Reports

* GOI Fiscal Year Apri1-March 31 Budget: A detailed costing of proposed implementation support activities indicates higher than standard supervision costs will be involved for this project. The project will implement new diagnosis and treatment policies and technologies these two diseases, and will require additional technical support. This together with the need to focus on states, regional launch workshops,

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participation in the state-level reviews, etc. a supervision budget of US$750,000 (variable cost) is proposed with US$150,000 a year. This takes into account the support likely to be available from the partners. The unit will explore the potential for engaging an external agency or consultant to seek to raise additional funds for timely technical support from external sources such as trust funds.

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Annex 13: Documents in the Project File

1. Environmental Assessment 2. Environment Management Plan 3. Social and Beneficiary Assessment 4. Vulnerable Communities Plan 5. Financial Management Assessment 6. Procurement Assessment 7. Joint Monitoring Mission Report 8. Manual on quality assurance of laboratory diagnosis of malaria 9. Baseline survey reports for malaria and kala azar 10. Draft Operational Manual

160

Annex 14: Statement of Loans and Credits

INDIA: Vector Borne Disease Control Project

Original Amount in US$ Millions

Difference between expected and actual

disbursements

Project ID FY Purpose IBRD IDA SF GEF Cancel. Undisb. Orig. Frm. Rev’d

P105124 2008 HP DPL I 135.00 65.00 0.00 0.00 0.00 100.90 -101.62 0.00

P102737 2008 Bihar DPL 150.00 75.00 0.00 0.00 0.00 114.28 -113.90 0.00

P101653 2008 Power System Development Project IV 600.00 0.00 0.00 0.00 0.00 600.00 0.00 0.00

P095114 2008 Rampur Hydropower Project 400.00 0.00 0.00 0.00 0.00 400.00 5.33 0.00

P090768 2007 TN IAM WARM 335.00 150.00 0.00 0.00 0.00 469.33 36.05 0.00

P090764 2007 Bihar Rural Livelihoods Project 0.00 63.00 0.00 0.00 0.00 64.43 -0.51 0.00

P090592 2007 Punjab Rural Water Supply and Sanitation

0.00 154.00 0.00 0.00 0.00 165.18 53.05 0.00

P090585 2007 Punjab State Roads Project 250.00 0.00 0.00 0.00 0.00 161.71 -50.24 0.00

P075060 2007 RCH II 0.00 360.00 0.00 0.00 0.00 340.30 57.59 0.00

P075174 2007 AP DPL III 150.00 75.00 0.00 0.00 0.00 75.70 -77.33 0.00

P078538 2007 Third National HIV/AIDS Control Project

0.00 250.00 0.00 0.00 0.00 224.89 25.00 0.00

P078539 2007 TB II 0.00 170.00 0.00 0.00 0.00 141.33 -18.18 0.00

P083187 2007 Uttaranchal RWSS 0.00 120.00 0.00 0.00 0.00 121.01 11.62 0.00

P102768 2007 Stren India's Rural Credit Coops 300.00 300.00 0.00 0.00 0.00 549.18 -75.00 0.00

P100789 2007 AP Community Tank Management Project

94.50 94.50 0.00 0.00 0.00 188.60 -3.33 0.00

P099047 2007 Vocational Training India 0.00 280.00 0.00 0.00 0.00 252.63 -27.35 0.00

P097036 2007 Orissa Socio-Econ Dev Loan II 150.00 75.00 0.00 0.00 0.00 75.54 -150.65 0.00

P096019 2007 HP State Roads Project 220.00 0.00 0.00 0.00 0.00 213.94 15.68 0.00

P071160 2007 Karnataka Health Systems 0.00 141.83 0.00 0.00 0.00 130.05 -7.84 0.00

P092735 2006 NAIP 0.00 200.00 0.00 0.00 0.00 194.75 17.56 0.00

P078832 2006 Karnataka Panchayats Strengthening Proj 0.00 120.00 0.00 0.00 0.00 97.56 -32.44 0.00

P086414 2006 Power System Development Project III 400.00 0.00 0.00 0.00 0.00 77.20 -212.80 0.00

P079675 2006 Karn Municipal Reform 216.00 0.00 0.00 0.00 0.00 187.05 22.72 0.00

P079708 2006 TN Empwr and Pov Reduction 0.00 120.00 0.00 0.00 0.00 111.51 8.99 0.00

P083780 2006 TN Urban III 300.00 0.00 0.00 0.00 0.00 226.17 61.92 0.00

P093720 2006 Mid-Himalayan (HP) Watersheds 0.00 60.00 0.00 0.00 0.00 48.97 1.61 0.00

P084632 2005 Hydrology II 104.98 0.00 0.00 0.00 0.00 91.19 60.05 17.19

P084790 2005 MAHAR WSIP 325.00 0.00 0.00 0.00 0.00 281.56 81.23 0.00

P084792 2005 Assam Agric Competitiveness 0.00 154.00 0.00 0.00 0.00 137.66 68.06 0.00

P077977 2005 Rural Roads Project 99.50 300.00 0.00 0.00 0.00 178.59 41.95 0.00

P077856 2005 Lucknow-Muzaffarpur National Highway 620.00 0.00 0.00 0.00 0.00 343.93 -12.73 0.00

P094513 2005 India Tsunami ERC 0.00 465.00 0.00 0.00 0.00 424.61 372.07 0.00

P075058 2005 TN HEALTH SYSTEMS 0.00 110.83 0.00 0.00 21.26 73.40 47.89 40.52

P086518 2005 SME Financing and Development 120.00 0.00 0.00 0.00 0.00 5.00 5.00 0.00

P073651 2005 DISEASE SURVEILLANCE 0.00 68.00 0.00 0.00 0.00 59.92 38.31 0.00

P073370 2005 Madhya Pradesh Water Sector Restructurin

394.02 0.00 0.00 0.00 0.00 344.76 144.71 0.00

P050655 2004 RAJASTHAN HEALTH SYSTEMS DEVELOPMENT

0.00 89.00 0.00 0.00 0.00 56.02 39.73 0.00

P073369 2004 MAHAR RWSS 0.00 181.00 0.00 0.00 0.00 22.17 -8.04 0.00

161

P073776 2004 ALLAHABAD BYPASS 240.00 0.00 0.00 0.00 0.00 63.96 48.76 0.00

P078550 2004 Uttar Wtrshed 0.00 69.62 0.00 0.00 0.00 54.01 0.85 0.00

P082510 2004 Karnataka UWS Improvement Project 39.50 0.00 0.00 0.00 0.00 9.36 8.69 0.00

P075056 2003 Food and Drugs Capacity Building Project

0.00 54.03 0.00 0.00 0.00 35.85 27.70 0.00

P073094 2003 AP Comm Forest Mgmt 0.00 108.00 0.00 0.00 0.00 33.16 7.37 0.00

P076467 2003 Chatt DRPP 0.00 112.56 0.00 0.00 21.36 70.08 64.85 0.00

P072123 2003 Tech/Engg Quality Improvement Project 0.00 250.00 0.00 0.00 40.11 15.80 1.66 -56.51

P071272 2003 AP RURAL POV REDUCTION 0.00 150.03 0.00 0.00 0.00 71.91 -17.99 0.00

P050649 2003 TN ROADS 348.00 0.00 0.00 0.00 0.00 159.52 105.32 0.00

P067606 2003 UP ROADS 488.00 0.00 0.00 0.00 0.00 180.86 169.65 0.00

P050668 2002 MUMBAI URBAN TRANSPORT PROJECT

463.00 79.00 0.00 0.00 0.00 332.70 304.79 0.00

P050653 2002 KARNATAKA RWSS II 0.00 151.60 0.00 0.00 15.04 36.50 22.43 0.00

P040610 2002 RAJ WSRP 0.00 140.00 0.00 0.00 25.84 57.25 40.76 0.00

P069889 2002 MIZORAM ROADS 0.00 60.00 0.00 0.00 0.00 33.90 3.54 0.00

P071033 2002 KARN Tank Mgmt 0.00 98.90 0.00 0.00 25.07 121.39 54.85 16.50

P050647 2002 UP WSRP 0.00 149.20 0.00 0.00 42.73 96.21 104.27 0.00

P072539 2002 KERALA STATE TRANSPORT 255.00 0.00 0.00 0.00 0.00 104.63 97.96 0.00

P074018 2002 Gujarat Emergency Earthquake Reconstruct

0.00 442.80 0.00 0.00 115.24 90.81 122.60 2.70

P055454 2001 KERALA RWSS 0.00 65.50 0.00 0.00 12.27 5.52 8.44 -4.64

P059242 2001 MP DPIP 0.00 110.10 0.00 0.00 20.06 0.28 6.77 -10.58

P067216 2001 KAR WSHD DEVELOPMENT 0.00 100.40 0.00 0.00 20.06 29.98 30.20 23.67

P071244 2001 Grand Trunk Road Improvement Project 589.00 0.00 0.00 0.00 12.53 100.70 113.23 0.00

P050657 2000 UP Health Systems Development Project 0.00 110.00 0.00 0.00 30.09 24.07 40.94 14.28

Total: 7,786.50 6,492.90 0.00 0.00 401.66 9,079.47 1,691.80 43.13

INDIA STATEMENT OF IFC’s

Held and Disbursed Portfolio In Millions of US Dollars

Committed Disbursed

IFC IFC

FY Approval Company Loan Equity Quasi Partic. Loan Equity Quasi Partic.

2005 ADPCL 39.50 7.00 0.00 0.00 0.00 0.00 0.00 0.00

2006 AHEL 0.00 5.08 0.00 0.00 0.00 5.08 0.00 0.00

2005 AP Paper Mills 35.00 5.00 0.00 0.00 25.00 5.00 0.00 0.00

2005 APIDC Biotech 0.00 4.00 0.00 0.00 0.00 2.01 0.00 0.00

2002 ATL 13.81 0.00 0.00 9.36 13.81 0.00 0.00 9.36

2003 ATL 1.00 0.00 0.00 0.00 0.68 0.00 0.00 0.00

2005 ATL 9.39 0.00 0.00 0.00 0.00 0.00 0.00 0.00

2006 Atul Ltd 16.77 0.00 0.00 0.00 0.00 0.00 0.00 0.00

2003 BHF 10.30 0.00 10.30 0.00 10.30 0.00 10.30 0.00

2004 BILT 0.00 0.00 15.00 0.00 0.00 0.00 15.00 0.00

2001 BTVL 0.43 3.98 0.00 0.00 0.43 3.98 0.00 0.00

162

2003 Balrampur 10.52 0.00 0.00 0.00 10.52 0.00 0.00 0.00

2001 Basix Ltd. 0.00 0.98 0.00 0.00 0.00 0.98 0.00 0.00

2005 Bharat Biotech 0.00 0.00 4.50 0.00 0.00 0.00 3.30 0.00

1984 Bihar Sponge 5.70 0.00 0.00 0.00 5.70 0.00 0.00 0.00

2003 CCIL 1.50 0.00 0.00 0.00 0.59 0.00 0.00 0.00

2006 CCIL 7.00 2.00 0.00 12.40 7.00 2.00 0.00 12.40

1990 CESC 4.61 0.00 0.00 0.00 4.61 0.00 0.00 0.00

1992 CESC 6.55 0.00 0.00 14.59 6.55 0.00 0.00 14.59

2004 CGL 14.38 0.00 0.00 0.00 7.38 0.00 0.00 0.00

2004 CMScomputers 0.00 10.00 2.50 0.00 0.00 0.00 0.00 0.00

2002 COSMO 2.50 0.00 0.00 0.00 2.50 0.00 0.00 0.00

2005 COSMO 0.00 3.73 0.00 0.00 0.00 3.73 0.00 0.00

2006 Chennai Water 24.78 0.00 0.00 0.00 0.00 0.00 0.00 0.00

2003 DQEL 0.00 1.50 1.50 0.00 0.00 1.50 1.50 0.00

2005 DSCL 30.00 0.00 0.00 0.00 30.00 0.00 0.00 0.00

2006 DSCL 15.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

2005 Dabur 0.00 14.09 0.00 0.00 0.00 14.09 0.00 0.00

2003 Dewan 8.68 0.00 0.00 0.00 8.68 0.00 0.00 0.00

2006 Federal Bank 0.00 28.06 0.00 0.00 0.00 23.99 0.00 0.00

2001 GTF Fact 0.00 1.20 0.00 0.00 0.00 1.20 0.00 0.00

2006 GTF Fact 0.00 0.00 0.99 0.00 0.00 0.00 0.99 0.00

1994 GVK 0.00 4.83 0.00 0.00 0.00 4.83 0.00 0.00

2003 HDFC 100.00 0.00 0.00 100.00 100.00 0.00 0.00 100.00

1998 IAAF 0.00 0.47 0.00 0.00 0.00 0.30 0.00 0.00

2006 IAL 0.00 9.79 0.00 0.00 0.00 7.70 0.00 0.00

1998 IDFC 0.00 10.82 0.00 0.00 0.00 10.82 0.00 0.00

2005 IDFC 50.00 0.00 0.00 100.00 50.00 0.00 0.00 100.00

IHDC 6.94 0.00 0.00 0.00 0.00 0.00 0.00 0.00

2006 IHDC 7.90 0.00 0.00 0.00 0.00 0.00 0.00 0.00

2006 Indecomm 0.00 2.57 0.00 0.00 0.00 2.57 0.00 0.00

1996 India Direct Fnd 0.00 1.10 0.00 0.00 0.00 0.66 0.00 0.00

2001 Indian Seamless 6.00 0.00 0.00 0.00 6.00 0.00 0.00 0.00

2006 JK Paper 15.00 7.62 0.00 0.00 0.00 7.38 0.00 0.00

2005 K Mahindra INDIA 22.00 0.00 0.00 0.00 22.00 0.00 0.00 0.00

2005 KPIT 11.00 2.50 0.00 0.00 8.00 2.50 0.00 0.00

2003 L&T 50.00 0.00 0.00 0.00 50.00 0.00 0.00 0.00

2006 LGB 14.21 4.82 0.00 0.00 0.00 4.82 0.00 0.00

2006 Lok Fund 0.00 2.00 0.00 0.00 0.00 0.00 0.00 0.00

2002 MMFSL 7.89 0.00 7.51 0.00 7.89 0.00 7.51 0.00

2003 MSSL 0.00 2.29 0.00 0.00 0.00 2.20 0.00 0.00

2001 MahInfra 0.00 10.00 0.00 0.00 0.00 0.79 0.00 0.00

Montalvo 0.00 3.00 0.00 0.00 0.00 1.08 0.00 0.00

1996 Moser Baer 0.00 0.82 0.00 0.00 0.00 0.82 0.00 0.00

1999 Moser Baer 0.00 8.74 0.00 0.00 0.00 8.74 0.00 0.00

2000 Moser Baer 12.75 10.54 0.00 0.00 12.75 10.54 0.00 0.00

Nevis 0.00 4.00 0.00 0.00 0.00 4.00 0.00 0.00

2003 NewPath 0.00 9.31 0.00 0.00 0.00 8.31 0.00 0.00

2004 NewPath 0.00 2.79 0.00 0.00 0.00 2.49 0.00 0.00

2003 Niko Resources 24.44 0.00 0.00 0.00 24.44 0.00 0.00 0.00

163

2001 Orchid 0.00 0.73 0.00 0.00 0.00 0.73 0.00 0.00

1997 Owens Corning 5.92 0.00 0.00 0.00 5.92 0.00 0.00 0.00

2006 PSL Limited 15.00 4.74 0.00 0.00 0.00 4.54 0.00 0.00

2004 Powerlinks 72.98 0.00 0.00 0.00 64.16 0.00 0.00 0.00

2004 RAK India 20.00 0.00 0.00 0.00 20.00 0.00 0.00 0.00

1995 Rain Calcining 0.00 2.29 0.00 0.00 0.00 2.29 0.00 0.00

2004 Rain Calcining 10.00 0.00 0.00 0.00 10.00 0.00 0.00 0.00

2005 Ramky 3.74 10.28 0.00 0.00 0.00 0.00 0.00 0.00

2005 Ruchi Soya 0.00 9.27 0.00 0.00 0.00 6.77 0.00 0.00

2001 SBI 50.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

1997 SREI 3.21 0.00 0.00 0.00 3.21 0.00 0.00 0.00

2000 SREI 6.50 0.00 0.00 0.00 6.50 0.00 0.00 0.00

1995 Sara Fund 0.00 3.43 0.00 0.00 0.00 3.43 0.00 0.00

2004 SeaLion 4.40 0.00 0.00 0.00 4.40 0.00 0.00 0.00

2001 Spryance 0.00 1.86 0.00 0.00 0.00 1.86 0.00 0.00

2003 Spryance 0.00 0.93 0.00 0.00 0.00 0.93 0.00 0.00

2004 Sundaram Finance 42.93 0.00 0.00 0.00 42.93 0.00 0.00 0.00

2000 Sundaram Home 0.00 2.18 0.00 0.00 0.00 2.18 0.00 0.00

2002 Sundaram Home 6.71 0.00 0.00 0.00 6.71 0.00 0.00 0.00

1998 TCW/ICICI 0.00 0.80 0.00 0.00 0.00 0.80 0.00 0.00

2005 TISCO 100.00 0.00 0.00 300.00 0.00 0.00 0.00 0.00

2004 UPL 15.45 0.00 0.00 0.00 15.45 0.00 0.00 0.00

1996 United Riceland 5.63 0.00 0.00 0.00 5.63 0.00 0.00 0.00

2005 United Riceland 8.50 0.00 0.00 0.00 5.00 0.00 0.00 0.00

2002 Usha Martin 0.00 0.72 0.00 0.00 0.00 0.72 0.00 0.00

2001 Vysya Bank 0.00 3.66 0.00 0.00 0.00 3.66 0.00 0.00

2005 Vysya Bank 0.00 3.51 0.00 0.00 0.00 3.51 0.00 0.00

1997 WIV 0.00 0.37 0.00 0.00 0.00 0.37 0.00 0.00

1997 Walden-Mgt India 0.00 0.01 0.00 0.00 0.00 0.01 0.00 0.00

2006 iLabs Fund II 0.00 20.00 0.00 0.00 0.00 0.00 0.00 0.00

Total portfolio: 956.52 249.41 42.30 536.35 604.74 175.91 38.60 236.35

Approvals Pending Commitment

FY Approval Company Loan Equity Quasi Partic.

2004 CGL 0.01 0.00 0.00 0.00

2000 APCL 0.01 0.00 0.00 0.00

2006 Atul Ltd 0.00 0.01 0.00 0.00

2001 Vysya Bank 0.00 0.00 0.00 0.00

2006 Federal Bank 0.01 0.00 0.00 0.00

2001 GI Wind Farms 0.01 0.00 0.00 0.00

2004 Ocean Sparkle 0.00 0.00 0.00 0.00

2005 Allain Duhangan 0.00 0.00 0.00 0.00

Total pending commitment: 0.04 0.01 0.00 0.00

164

Annex 15: Country at a Glance

INDIA: Vector Borne Disease Control Project

P OVER T Y and SOC IA L So uth Lo w-

India A sia inco me2006Population, mid-year (millions) 1,109.8 1,493 2,403GNI per capita (Atlas method, US$) 820 766 650GNI (Atlas method, US$ billions) 910.0 1,143 1,562

A verage annual gro wth, 2000-06

Population (%) 1.5 1.7 1.9Labor force (%) 1.9 2.1 2.3

M o st recent est imate ( latest year available, 2000-06)

Poverty (% of population below national poverty line) 29 .. ..Urban population (% of to tal population) 29 29 30Life expectancy at birth (years) 64 64 59Infant mortality (per 1,000 live births) 56 62 75Child malnutrition (% of children under 5) .. .. ..Access to an improved water source (% of population) 86 84 75Literacy (% of population age 15+) 61 58 61Gross primary enro llment (% of school-age population) 119 110 102 M ale 123 115 108 Female 116 105 96

KEY EC ON OM IC R A T IOS and LON G-T ER M T R EN D S

1986 1996 2005 2006

GDP (US$ billions) 246.4 388.3 805.7 911.8

Gross capital formation/GDP 23.0 22.1 33.4 33.9Exports o f goods and services/GDP 5.3 10.5 20.3 23.0Gross domestic savings/GDP 21.2 20.9 30.4 31.1Gross national savings/GDP 21.6 23.2 32.7 33.5

Current account balance/GDP -2.0 -1.3 -1.2 -1.1Interest payments/GDP 0.7 1.0 0.8 ..Total debt/GDP 19.5 24.1 15.3 ..Total debt service/exports 32.5 22.2 12.5 ..Present value of debt/GDP .. .. 13.7 ..Present value of debt/exports .. .. 56.9 ..

1986-96 1996-06 2005 2006 2006-10(average annual growth)GDP 5.5 6.4 9.2 9.2 ..GDP per capita 3.5 4.7 7.7 7.7 ..Exports o f goods and services 11.8 13.4 5.9 8.6 ..

ST R UC T UR E o f the EC ON OM Y

India Low-income group

D evelo pment diamo nd*

Life expectancy

Access to improved water source

GNIpercapita

Grossprimary

enro llment

India Low-income group

Eco no mic rat io s*

Trade

Indebtedness

Domesticsavings

Capital formation

165

1986 1996 2005 2006(% of GDP)Agriculture 30.0 27.4 18.3 17.5Industry 26.3 27.0 27.6 27.9 M anufacturing 16.4 17.5 16.0 16.3Services 43.7 45.6 54.1 54.6

Household final consumption expenditure 66.9 68.4 58.3 57.6General gov't final consumption expenditure 11.9 10.7 11.3 11.3Imports o f goods and services 7.1 11.7 23.3 25.8

1986-96 1996-06 2005 2006(average annual growth)Agriculture 3.7 2.3 6.0 2.7Industry 6.2 6.4 9.6 10.6 M anufacturing 6.5 5.9 9.1 12.3Services 6.6 8.2 9.8 11.2

Household final consumption expenditure 5.2 4.7 6.1 7.5General gov't final consumption expenditure 4.0 5.3 9.8 9.0Gross capital formation 7.0 9.1 18.8 14.2Imports o f goods and services 10.8 9.9 10.3 11.4

Note: 2006 data are preliminary estimates.This table was produced from the Development Economics LDB database.

* The diamonds show four key indicators in the country (in bo ld) compared with its income-group average. If data are missing, the diamond will be incomplete.

-10

0

10

20

30

01 02 03 04 05 06

GCF GDP

Gro wth o f capital and GD P (%)

0

10

20

30

01 02 03 04 05 06

Exports Imports

Gro wth o f expo rts and impo rts (%)

India

P R IC ES and GOVER N M EN T F IN A N C E1986 1996 2005 2006

D o mestic prices(% change)Consumer prices 8.7 9.0 4.2 5.8Implicit GDP deflator 6.8 7.5 4.4 5.9

Go vernment f inance(% of GDP, includes current grants)Current revenue 19.6 17.5 19.7 21.6Current budget balance -2.3 -3.5 -3.1 -1.9Overall surplus/deficit -9.9 -6.4 -6.8 -6.5

T R A D E1986 1996 2005 2006

(US$ millions)Total exports (fob) 10,413 34,133 105,152 127,090 M arine products 414 1,129 1,589 1,744 Ores and minerals 476 1,172 6,164 7,033 M anufactures 6,564 24,613 72,563 82,818Total imports (cif) 17,729 48,948 156,993 191,995 Food 1,028 1,214 2,767 3,291 Fuel and energy 2,371 10,036 43,963 57,074 Capital goods 4,914 9,922 37,666 52,944

Export price index (2000=100) 101 104 .. ..Import price index (2000=100) 119 115 .. ..Terms of trade (2000=100) 85 90 .. ..

0

50,000

100,000

150,000

200,000

250,000

00 01 02 03 04 05 06

Exports Imports

Expo rt and impo rt levels (US$ mill.)

0

2

4

6

8

01 02 03 04 05 06

GDP def lator CPI

Inf lat io n (%)

166

B A LA N C E o f P A YM EN T S1986 1996 2005 2006

(US$ millions)Exports o f goods and services 13,630 41,607 166,556 208,420Imports o f goods and services 19,951 55,696 194,516 240,598Resource balance -6,321 -14,089 -27,960 -32,178

Net income -977 -3,307 -5,510 -4,846Net current transfers 2,327 12,367 24,102 27,195

Current account balance -4,971 -5,029 -9,368 -9,829

Financing items (net) 4,397 10,847 23,582 45,164Changes in net reserves 574 -5,818 -14,214 -35,335

M emo :Reserves including gold (US$ millions) 6,574 26,423 150,866 198,710Conversion rate (DEC, local/US$) 12.8 35.5 44.3 45.2

EXT ER N A L D EB T and R ESOUR C E F LOWS1986 1996 2005 2006

(US$ millions)Total debt outstanding and disbursed 48,124 93,466 123,123 .. IBRD 3,475 8,768 5,557 6,177 IDA 10,529 17,616 23,363 24,068

Total debt service 5,273 11,981 24,335 .. IBRD 469 1,514 417 597 IDA 152 364 809 841

Composition o f net resource flows Official grants 595 589 1,060 .. Official creditors 1,404 184 1,421 .. Private creditors 2,793 -146 379 .. Foreign direct investment (net inflows) 118 2,426 6,598 .. Portfo lio equity (net inflows) 0 3,958 12,152 ..

World Bank program Commitments 1,790 1,725 1,592 208 Disbursements 1,297 1,592 2,130 1,787 Principal repayments 235 1,074 843 942 Net flows 1,062 518 1,288 845 Interest payments 386 804 384 496 Net transfers 676 -287 904 349

Note: This table was produced from the Development Economics LDB database. 9/28/07

-2

-1

0

1

2

3

00 01 02 03 04 05 06

C urrent acco unt balance to GD P (%)

G: 8,788A: 5,557

D: 3,476

B: 23,363

F: 63,356 E: 18,583

A - IBRDB - IDA C - IM F

D - Other mult ilateralE - BilateralF - PrivateG - Short-term

C o mpo sit io n o f 2005 debt (US$ mill.)