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Indian Immunization Programme A Literature Review

Imprimis Research and Advocacy November 2012

The study breaks new ground in trying to identify a strategic action plan to increase immunization coverage. It is therefore important that Indian stakeholders and policy makers plan strategies to enhance the coverage of the National Immunization Programme. in no way be treated as the official views of Imprimis PR or its consultants. Aman Gupta Chief Executive Officer . The views expressed herein should. I hope practitioners in this field and Indian strategists find this study useful. But many areas in India still lack access to vaccines. however. Learning and the Way Forward” in this domain.Foreword Vaccines are a strong health tool and have been cost-effective and successful in saving children’s lives. Imprimis PR has launched a new Research and Advocacy wing and we aim to embark on research in the Indian Immunization Programme to present “Analysis.

4.2.3.) Introduction of new vaccine – Decision Making Process 2. Appendix 4: Summary of WHO position papers .2. Indian factsheet for 2010 3.1b. Conclusion 13 13 14 18 24 Section 3: Appendix and Reference (sources) 3. Immunization Policy – History behind the programme 1.1.4.1.) Vaccine market 2.3. Appendix 3: India reported immunization coverage 3.1a.3. Vaccine market and policy framework 2. Role of Centre and State Government in Healthcare Financing 1. Decisive Factors Affecting Immunization 1 3 7 9 Section 2: Vaccination Market and Strategic Approach for India 2. Appendix 2 : WHO and UNICEF present country-level data on immunization status.Index Section 1: Immunization Policy in India 1. Appendix 1: India’s progress on the MDGs for 2015 3.Recommendations for Routine Immunization (updated 31 May 2012) 27 27 29 30 Table and Figures Index Frequently Used Abbreviations References and Sources 31 31 32 . India Immunization Status 1.2 Challenges and Strategic Action Points to improve immunization coverage 2.1.

increasing productivity. framework and authorities at work are crucial pivots in Indian Immunization Programme. Section 1 helps in understanding the launch of the Immunization Programme in India. Through this section we have done the ground analysis and presented the core literature in a nutshell. We have done a review of existing studies to understand the determining factor affecting Immunization via use of regression model. Section 2 Vaccination policy. There are challenges and obstacles that need to be taken care of by the policy managers and makers. development span. . The study presented the conclusion and strategic action points to reach the desired goal of UIP in India. The study discusses the role of central and state governments in a successful campaign. Section 3 supports the data points and provides extra information related to the subject. thereby highlighting the growth trajectory and current coverage status of the immunization programme. and alleviating poverty. We have begun with the literature review to understand the scope. We have examined the history behind the programme. and role of the government and the current status for the success of the Indian Immunization Programme. It is in this context that Imprimis Research and Advocacy has undertaken this study. Sources are mentioned in the end for readers’ reference.Executive Summary Immunizing children against vaccine-preventable diseases is a crucial instrument in saving lives. We scrutinized decision making process necessary for introduction of a new vaccine in the immunization programme.

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of India (GoI). More than 90 million pregnant women and 83 million infants were to be immunized over a five-year period under the UIP (Sokhey 1988). diphtheria. • More than 100 million infants are immunized each year. UIP became a part of the Child Survival and Safe Motherhood (CSSM) Programme in 1992-93 (MoHFW 2002-03: 176). As part of the National Health Policy. Table 1: Quick Facts: Immunization: • Immunization has saved more than 20 million lives in the last two decades. The GoI constituted a National Technical Committee on Child Health on 11th June 2000 and launched immunization Strengthening Project on the recommendation of the Committee (MoHFW 2002-03: 173). • Immunization coverage against HepB and HiB has been increasing since 1990 – more than 160 countries now include HepB and HiB into infant immunization schedules Source: UNICEF/WHO. Immunization Policy: History behind the programme Immunization – Definition Immunization programme is one of the essential interventions for protection of children from life-threatening diseases that are preventable. the UIP is being implemented on priority basis. Sokhey 1985). November 2011 1 Section 1: Immunization Policy in India . a planned strategy launched in 1985-86. The programme was given the status of a National Technology Mission in 1986 (GoI 1988) to provide a sense of urgency and commitment to achieve the goals within the specified period.Indian Immunization Programme A Literature Review 1. to 164. saving 2-3 million lives annually.1. pertussis or whooping cough. Universal Immunization Programme (UIP) The Universal Immunization Programme (UIP). immunization activities have been an essential part of the National Reproductive and Child Health (RCH) Programme (MoHFW 2005-06: 54). MoHFW 1985. The Department of Family Welfare established a National Technical Advisory Group on Immunization on 28th August 2001 to assist the GoI in developing a nationwide policy framework for vaccines and immunization (MoHFW 2002-03: 174). and measles) are available free of cost for all. vaccines for six vaccine-preventable diseases (tuberculosis. Universal childhood immunization has been accepted by world public health leaders and stakeholders as both an affordable and cost effective strategy for promoting primary healthcare and for child survival. • Global mortality attributed to measles declined by 78 % from an estimated 733. aimed at systematic districtwise expansion to cover all the districts by 1989-90 (Govt. poliomyelitis. The immunization programme in India was flagged off in 1978 as Expanded Programme on Immunization (EPI).000 deaths in 2000.000 in 2008. The standard immunization schedule developed for the child immunization programme specifies the age at which each vaccine is to be administered and the number of doses to be given. In India. Since 1997. tetanus. under the Universal Immunization Programme. It gained impetus in 1985 as the Universal Immunization Programme (UIP) and was carried out in a phased manner to cover all districts in the country by 1989-90 (MoHFW 2006-07: 58).

Survey responses provide information on fertility. and important aspects of nutrition. UIP became operational in all districts in the country during 1989-90 UIP and ORT universalized in all districts. and nutrition services was integrated with family planning services. The objective to cover at least 85% of all infants against the six vaccine-preventable diseases by 1990 and to achieve self-sufficiency in vaccine production and the manufacture of cold-chain equipment The Acute Respiratory Infection (ARI) Control Programme was launched in India. 2 2 . 92. as well as 74. teams interviewed. UNFPA and European Commission etc. For NFHS-1. mortality. The RCH Programme is partly funded by World Bank. of India (GoI) strengthens steps for maternal and child health services. 124. UNICEF has been conducting a Coverage Evaluation Surveys (CES) every year since 1995 (except during 2002-04) to assess the key indicators related to the Universal Immunization Programme and maternal care services UIP became a part of the Reproductive and Child Health (RCH) Programme The District Level Household Survey (DLHS) was initiated in 1997 with a view to assess the utilization of services provided by government health care facilities and people’s perceptions about the quality of services GOI launched the Reproductive and Child Health (RCH) Programme2 for implementation during the 9th Plan period by integrating Child Survival and Safe Motherhood (CSSM) Programme with other RCH services NFHS 2 and DLHS 1 National Technical Committee on Child Health constituted by GOI and launched Immunization Strengthening Project The Department of Family Welfare established a National Technical Advisory Group on Immunization to assist GoI in developing a nationwide policy framework for vaccines and immunization 1983 1985 1985-86 1986 Section 1: Immunization Policy in India 1989-90 1990 1990 1992 1992-93 1995 1995 1997 1997 During 199798 1998-99 2000 2001 ___________________________________________________ 1 NFHS-I. health.369 men age 15-64. ARI Programme taken up as a pilot in 26 districts UIP became a part of the Child Survival and State Motherhood (CSSM) Programme India's first National Family Health Survey1 (NFHS-1) was conducted under the auspices of the Ministry of Health and Family Welfare Pulse Polio Immunization Programme began as part of a major national effort to eradicate polio At the request of the Government of India. For NFHS-2. and health care.385 married and unmarried women age 15-49 were interviewed. child health. and NFHS-3 are among the most complete surveys of their kind ever conducted in India. family planning. UNICEF. NFHS-2.300 ever-married women age 15-49. Years mentioned represent First and Second Five-Year Plans respectively Minimum Needs Programme with a focus on maternal health. 1974-78 represent Fifth Five-Year Plan Expanded Programme on Immunization initiated in India: objective to reduce morbidity.777 ever-married women between the ages of 13 and 49.Indian Immunization Programme A Literature Review Table 2: Child Health Programme in India: 1950-2012 Year 1951-56 and 1956-61 1974-78 1978 Immunization Programme Span and Focus Govt. For NFHS3. survey teams interviewed 89. mortality and disabilities by making free vaccination services easily available to all eligible children and pregnant women by 1990 Goal set in the National Health Policy (1983) to cover universal immunization against six vaccine preventable diseases (VPD) by 2000 Oral Rehydration Therapy (ORT) Programme for prevention of deaths due to diarrhea UIP was launched to extend immunization coverage among eligible children and to improve the quality of services Programme was given the status of a National Technology Mission Planned strategy for systematic district-wise expansion of the immunization programme to cover all the districts.

CES NFHS 3 DLHS 3 CES 2009 was conducted between November 2009 and January 2010 covering all States and Union Territories. Since January 2012.000 500.109 18. India Immunization Status The Universal Immunization Programme in India is among the largest immunization programmes in the world. diphtheria. India has officially eradicated polio within its borders and is no longer considered a polio-endemic country. Meghalaya. Himachal Pradesh and Jammu & Kashmir.073 3.570 37.181 559 811 3.000 300. poliomyelitis. Under the UIP. Tripura.647 8. and measles. Jharkhand.2. 2005 2005-06 2007-08 2009 2012 Source: Compilation by Imprimis Research 1.125 38.231 114.081 48.685 161. Figure 1: Vaccine preventable diseases: India reported cases (Year wise) 600. tetanus.494 4. GoI. targeting 27 million infants and 30 million pregnant women as indicated by National Vaccine Policy 2011.714 Tetanus (Neonatal) Tetanus (Total) Source: WHO Vaccine-preventable Diseases: Monitoring System 2010 Global Summary ___________________________________________________ 3 The 18 high-focus States are Uttar Pradesh.181 44. Its special focus was on 18 States3 with weak public health indicators.000 100.783 - 5.216 184.036 320.543 6. vaccines are available free of cost for all for six vaccine-preventable diseases – tuberculosis.368 22. The programme is administered by the Immunization Division of the MoHFW.454 13. Orissa.000 0 Year Diphtheria Measles Pertussis Poilo 1980 1985 1990 1995 2000 2005 2008 39.000 400.287 8. Assam.835 31.408 9. Rajasthan. Mizoram. Bihar. Nagaland.Indian Immunization Programme A Literature Review Year 2002-04 2005 Immunization Programme Span and Focus DLHS 2 The National Rural Health Mission (NRHM) was launched by the Government of India with a vision to improve health care for the rural population throughout the country. 3 Section 1: Immunization Policy in India .123 37.431 265 3.231 52. Sikkim.268 1. Madhya Pradesh. Arunachal Pradesh. Manipur.997 10.000 200.425 89.948 15.975 45.612 112.416 10. Chhattisgarh.313 23. pertussis (whooping cough). Uttaranchal.356 2.955 66 891 3.

These goals are mentioned in the chart above. 1958-87. In September 2010.Indian Immunization Programme A Literature Review Table 3: WHO recommends National Immunization Schedule for India Vaccine Birth Primary vaccination BCG Oral polio DPT Hepatitis B* Measles Booster Doses DPT + Oral polio DT Tetanus toxoid (TT) Vitamin A Pregnant women Tetanus toxoid (PW): 1st dose 2nd dose Booster As early as possible during pregnancy (first contact) 1 month after 1st dose If previously vaccinated. the world recommitted itself to accelerate progress towards these goals. *WHO/WB estimates Source: WHO Estimates Reducing child mortality by two thirds between 1990 and 2015 is the fourth of eight Millennium Development Goals (MDGs)5 endorsed by world leaders in the Millennium Declaration in 2000.5 million deaths occur among children below five years of age.5 million deaths among children under 5 years were due to diseases that could have been prevented by routine vaccination. 18. within 3 years 16 to 24 months 5 years At 10 years and again at 16 years 9. Epub 2010 May 11. of which approximately 1.375. In 2008. In the year 2000. This represents 17% of global total mortality in children under 5 years of age. 2010 Jun 5. Lancet. assessment and monitoring: vaccine preventable diseases.9730).4 Figure 2: Global Total Mortality in Children under 5 years Measles 8% Perlussis 13% Tatanus 4% Pneumoccocal diseases* 32% Hib* 13% Rotavirus* 30% Source : Black RE et al. ___________________________________________________ 4 5 WHO Immunization surveillance. regional and national causes of child mortality in 2008: a systemic analysis. United Nations. the heads of 189 nations made a promise to free people from extreme poverty and multiple deprivations. WHO estimated that 1. 4 . vaccine preventable diseases (VPDs) cause an estimated 2 million deaths or more every year. This pledge became the eight Millennium Development Goals to be achieved by 2015. As per The Millennium Development Goals Report. 24. 2011. Global. 30 and 36 months X X ---------6 weeks ---X X X X X X X X X X ---------Age 10 weeks 14 weeks 9-12 months Section 1: Immunization Policy in India Source: India Development Gateway (InDG) – Child Immunization details (Note: Only in project areas) According to United Nations Children’s Fund (UNICEF) 2005.

and bottlenecks to improving coverage levels are available.” India is one of the signatories committed to achieve MDGs. The coverage of immunization was higher in urban areas (67. The contribution of immunization is especially critical to achieving the goal to reduce deaths among children under five years old (MDG 4). They are critical for reaching the MDGs worldwide. The realization of the MDGs goals in India is vital for attaining human development and economic growth within the country. given India’s enormous size.Millennium Development Goals For more details: Refer Appendix 1: India’s progress on the MDGs for 2015 (at the end). and saves millions of lives every year. 5 Section 1: Immunization Policy in India . UNICEF organized a coverage evaluation survey in 2009 (CES 2009) to assess the utilization of maternal. it is crucial that appropriate and accurate information about immunization coverage levels among all children and selected group. every fifth person in the world is an Indian. newborn and child health services including immunization. The report. At the all-India level.Indian Immunization Programme A Literature Review Figure 3: Millennium Development Goals – The Eight Goals for 2015 Eradicate Extreme Hunger and Poverty Improve Maternal Health Achieve Universal Primary Education Combat HIV/AIDS. ‘State of the World’s Vaccines and Immunizations’ by UNICEF states that. status and quality of immunization services.4%) compared to that in rural areas (58. To develop and implement effective strategies for improving immunization coverage. It is also key to achieving the MDGs – commitments made by world leaders in 2000 to reduce poverty and improve human development.a nationwide survey covering all the States and Union Territories of India and was conducted at the request of the Government of India. “Immunization is one of the most powerful and cost-effective of all health interventions. The Coverage Evaluation Survey 2009 -. 61 % of children aged 12-23 months received full immunization. It prevents debilitating illness and disability. As per MoHFW presentation mentioning an overview of Universal Immunization programme in June 2012. A region wise coverage is presented in the figure 4. To ensure data availability.5%). India has achieved 61% Full Immunization Coverage as evaluated in CES 2009. Malaria and other Diseases Promote Gender Equality and Empower Women Ensure Environmental Sustainability Reduce Child Mortality Develop a Global Partnership for Development Source: UNDP in India website page .

5 61.9 53. 50-70% in 13 states and below 50% in the rest of the 8 states.2 54.5 Persentage 60 40 20 0 BCG OPV3 DTP3 Measles HEP-B3@ Fully Immunized @ 3 doses of Hepatitis B vaccine coverage among 12-23 months old children in 16 States/UTs where it is part of UIP Source: India’s Universal Immunization Programme Presentation by Anuradha Gupta at GAVI Alliance Board Meeting 13 June 2012.9 43. Washington DC The coverage of UIP vaccines in this country is >70% only in 11 states.1 58.Anuradha Gupta at GAVI Alliance Board Meeting 13 June 2012.5 42.604) 74. Washington DC. which brings down the national average below 50%.0 45.CES 2009 INDIA-Full Immunization Coverage by various Survey 700 600 500 400 300 200 100 35.4 71. Figure 5: Immunization among children (%) of 12-23 months shown below: 100 86.9 (n=22. The last group also happens to include the most populous states.0 54.5 Fully Immunized children (12-23 months) 61% Full Immunization Coverage (evaluated 2009) Section 1: Immunization Policy in India 00 NFHS1 NFHS2 DLHS1 DLHS2 CES NFHS3 DLHS3 (1992-93) (1998-99) (1998-99) (2002-04) (2005) (2005-06) (2007-08) CES (2009) Source: India’s Universal Immunization Programme Presentation.9 61 80 70. This is an area of concern and issues need to be addressed to improve UIP programme performance. CES 2009 6 .Indian Immunization Programme A Literature Review Figure 4: Immunization Coverage.

where states with the poorest health indicators get a larger share of the allocations. Indian facts for 2010 and WHO fact sheet) 1.29 in 2005–06 to 0. July 2004 working paper “Analysis of public expenditure on health using State level data” explained Centre and state roles in public healthcare expenditures. The central sponsored programmes have been one key policy initiative of the Government of India to support the health sector programmes directly.Undertaken for the MacArthur Foundation. This pattern also holds good for health-related expenditure. New Delhi. This is much faster than the states. procurement. now adopted by Government of India. however. as well as some joint spending6. As per the 11th Five Year Plan (2007-12). 85% of the funds come from the Centre and the rest from the states. “Analysis of Public Expenditure on Health Using State Level Data. States. The Centre provides direct and partial (matching grant) support to the states in meeting both recurring and non-recurring expenditure of programmes under this policy initiative8 .” The policy also touches the aspects related to vaccine security in the country and vaccination programmes in broader framework of National Health Policy of India.39 in 2009–10. To strengthen the vaccine outreach in India. This is also a reflection of the fact that state governments are going through serious fiscal problems. The policy. The role of central support in state budgetary allocations is increasing. therefore.” IIMA Working Papers WP2004-06-08 6 7 Section 1: Immunization Policy in India . . where the increase was from 0. but state governments are predominantly responsible for most health provisions. the Ministry of Health and Family Welfare released a draft National Vaccine Policy in April 2011.August 2006 7 Bhat. linking geographical Information System with UIP network to track delivery of vaccines and encouraging PPPs through flexible governing and grants. GOI allocations for individual states are based on a weightage system. Ahmedabad. “Looking at the contributions of the Centre and the states (Figure 6). Indian Institute of Management. Role of Centre and State Governments in Healthcare Financing Health is a concurrent subject under the Indian constitution. the policy document is a crucial reference guide for the adoption of new vaccines and formulating vaccine strategies in India. Now almost one and half years later. Generally. and quality assessment of vaccines for UIP in India. production. In addition to direct central government spending on specific budget items. Policy further underlines the significance of active Public Sector Units (PSUs). Political and leadership factors also play roles in the success of vaccination programmes. the Centre’s health expenditure as percentage of GDP increased from 0. Refer: Appedix ( WHO and UNICEF presents the country level data on immunization status.67 to 0. R. the private expenditure on healthcare is increasing.” Working Paper No.3. ___________________________________________________ Government Health Expenditure in India: A Benchmark Study..70 over the same period. there is a range of centrally mandated expenditures that are also effectively spent by state governments. India. WP 2004-06-08.Indian Immunization Programme A Literature Review Mass immunization for protection from infectious diseases is one of the greatest achievements of modern medicine and its benefits have been eloquently set out. “Analysis of Public Expenditure on Health Using State Level Data. seeks “to develop a long-term plan to strengthen the whole vaccine programme and intends to provide broader policy guidelines and framework to guide the creation of evidence base to justify the need for R&D. The states’ share in the total revenue expenditure has been declining. The paper7 highlights “the total public healthcare expenditure is composed of state level allocations and allocations from central government”. Economic Research Foundation. both curative and public health aspects. have to substantially increase their health budgets”. 8 Bhat Ramesh & Jain Nishant. Still in comparison to public expenditure.

and mainly in the Twelfth Plan (2012-17) to achieve this goal. realizing true potential” is projecting positive outlook and state that the current growth trajectory (in graph below) will take the government’s healthcare spending up to 1. and the public expenditure elasticity with respect to GDP was at 0.16) for the same period (Tandon and Cashin. the expenditure increased only marginally to 1. 2012). Despite efforts to increase public spending after 2005-06 including the adoption of National Rural Health Mission (NRHM). 8 . and nutrition. total government spending on health was stagnant at about 1 % of GDP.Indian Immunization Programme A Literature Review Figure 6: Public Expenditure allocation – Centre and State Section 1: Immunization Policy in India Note: *Provisional **Besides expenditure by health and family welfare departments. McKinsey report “India Pharma 2020: Propelling access and acceptance.94. A very strong effort will be needed in the last year of the Eleventh Plan (2007-12 i.2 % of GDP in 2009-2010. sanitation. lower than the average for low-income countries (1.6% of GDP by 2020. this includes estimated expenditure on RSBY. Between 1996-97 and 2005-06. water supply.e. 2010). Source: Eleventh Five Year Plan (2007-2012) The total allocation of plan and non-plan resources for health for the Centre and the states combined remains low compared to the target of taking it to 2–3 per cent of GDP.

” 1. Gender bias is an important obstacle against improving immunization coverage. It also affects mortality and fertility inversely.4. “Government spending on healthcare in India should be raised to at least 4% of the nation’s gross domestic product (GDP) from the current 1% to meet basic healthcare requirements under proposed Universal Health Coverage (UHC) programme. Majority of first-order births occur to younger women who are more likely than older women to utilize maternal and child healthcare services. Decisive Factors Affecting Immunization Nilanjan Patra in his study paper “Universal Immunization Programme in India: The determinants of childhood immunization” analyses the effects of some select demographic and socioeconomic predictor variables on likelihood of immunization of a child for six vaccine-preventable diseases covered under UIP. realizing true potential“ As per a study done by Ernst and Young in September 2012.Indian Immunization Programme A Literature Review Figure 7: Healthcare spending by Government in India Source: McKinsey report “India Pharma 2020: Propelling access and acceptance. His immunization coverage model is used in this study to describe the effects of the select background variables on immunization coverage. Table 4: Regression model analysis stating factors and their relationship with Immunization Factor Education Sex of child Birth order Relation with Immunization + + + Description Education is an important determinant of immunization coverage. 9 Section 1: Immunization Policy in India . There is a consistently inverse relationship between immunization coverage and birth order of a child.

The chance of immunization also seems to vary with religion. (b) in rural and urban areas in India. namely. The likelihood of being fully immunized is higher for children from Christian and other minority communities and lower for children from the Muslim community compared to their counterparts from Hindu households. It focuses on immunization coverage for children (a) across entire India. was also considered to examine its effect on the likelihood of vaccination as around half of Indian mothers are illiterate. There is strong effect of zone of states on immunization. Tamilnadu (two extremes in immunization coverage performance) and West Bengal (national average). Antenatal care during pregnancy is positively associated with childhood immunization. The wealth index also has a significantly strong positive effect on immunization. Caste/ tribe also affect immunization coverage.Indian Immunization Programme A Literature Review Residence Mother’s education Father’s education + + + Urban children are much more likely to be fully vaccinated than rural ones. Bihar. Mother’s age Antenatal care Religion + + +/- Section 1: Immunization Policy in India Caste/tribe +/- Standard of living (SLI) Wealth Index Media Exposure Mother’s Awareness Sex of Household Head Mother Empowerment Index (MEI) Zone + + + + + +/- Electricity + Source: Compilation by Imprimis Research. Sex of household headship affects immunization mainly through other predictor variables correlated with sex of household headship. Review of Nilanjan Patra study The study analyses the effects of some select demographic and socioeconomic predictor variables on the chance of immunization of a child. Electricity also has significant effect on full immunization in India. Chance of immunization of children increases with their mother’s age only up to the age group of 25-29 and then decreases. There is a strong positive relationship between mother’s education and children’s immunization coverage. (d) for groups of states. (c) for DPT. Polio and partial immunization for all India. father’s education. Another variable. The chance of immunization increases with the standard of living index of the child’s household. 10 . Media exposure has a significantly positive effect on immunization. Mother’s empowerment indexes are almost positively related to immunization coverage. Mother’s awareness about immunization also has significantly strong positive effect on vaccination. The chance of being fully vaccinated is consistent with the relative traditional social hierarchy of castes/ tribes. The immunization rate varies widely across different zones as well as within the same zone. Northeastern and other states. and (e) for three states namely.

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In India companies such as Serum Institute. provide vision.7 billion by 2017 with a CAGR of 11. CDSCO CLAA 13 Section 2: Vaccination Market and Strategic Approach for India . and Non-governmental organizations provide important knowledge and credibility in addition to crucial financial support. essential preventive medicines for primary “healthcare” and critical component of a nation’s health security. The important international players in the vaccines market are GlaxoSmithKline.1. The political will and governmental support for improving public health must be in place to make vaccination work. from infants to seniors. Global Immunization GIVS is the first ever ten-year (2006-2015) framework aimed at controlling morbidity Vision and Strategy (GIVS) and mortality from vaccine-preventable diseases and helping countries to immunize more people. Vaccine Market and Policy Framework 2.1A) Vaccine Market – India and Global Vaccines are a crucial discovery of the times.Indian Immunization Programme A Literature Review 2. delivery. the National Regulatory Authority (NRA). World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF) Gates Foundation Rotary International Purpose These international bodies focus broadly on vaccine procurement. the participation of international bodies. the overall global vaccines market was valued at US$ 28 billion in 2010 and is expected to reach US$ 56. and monitoring.e. with a greater range of vaccines. representing around 88% of the total vaccine segment globally. The mission of the WHO Initiative for Vaccine Research (IVR) is to guide. Pfizer. Asian Vaccination Initiative The Asian Vaccination Initiative (AVI) of the Asian Development Bank (ADB) can offer loans for immunization programmes to countries in the region. Shantha Biotechnics. i. Sanofi. Table 6: Authorities at work on Vaccination and Immunization in India Organization DCGI Purpose The vaccines licensing authority in India. Bharat Biotech and Panacea Biotech are poised to take greater strides in this direction. The infrastructure to support disease surveillance and vaccine delivery is essential. and then those Alliance (launched in 2000) countries are prepared and equipped to deliver them. Novartis AG. The Central Drugs and Standards Control Organization (CDSCO) is the National Regulatory Authority (NRA) in India. Oftentimes.5%. effective and affordable vaccines against infectious diseases of public health importance. and facilitate the development. (launched in 2006) Source: Compilation by Imprimis Research According to GBI Research Report. enable. CDSCO is headed by the Drugs Controller General (India) [DCG(I)] Licensing of products in India is by the Central Licensing Approval Authority (CLAA). Table 5: Global and International Organizations Organization World Bank. support. non-governmental organizations and other country specific agencies are critical to success. Global Alliance for Vaccines Role is to ensure that new and underused vaccines are available to low-income and Immunization (GAVI) countries at an affordable price and within a shorter time period. especially in developing countries. clinical evaluation and world-wide access to safe. which is approved by World Health Organization (WHO). GAVI Partners The GAVI partners have created the Global Fund for Children’s Vaccines (GFCV) to fund poorer countries (annual per capita income less than US$1000) for new vaccines and infrastructure development. Merck and SP-MSD. is the Drugs Controller General of India (DCGI).

1B) Introduction of New Vaccine – Decision-making process The decision to add a new vaccine is complex. realizing true potential” stated that at 2% penetration. As per National Vaccine Policy 2011. vaccine cost. Is the disease a public health problem? 2. There are both central and state licensing authorities. the vaccines market of India is significantly under-penetrated with an estimated turnover of around US$ 250 million. Good Clinical Practice (GCP) and ethical guidelines by Indian Council of Medical Research (ICMR) for approval exist.Indian Immunization Programme A Literature Review Organization NTAGI DATB ICMR Purpose NTAGI advises the national government regarding the technical issues related to vaccination and immunization. The Indian domestic market for UIP alone is 100 million doses. and net impact (on immunization programme as well as health sector). WHO 2005 14 . Is the immunization programme working well enough to add a vaccine? 4. Is the vaccine a good investment? 6. Source: Compilation by Imprimis Research Section 2: Vaccination Market and Strategic Approach for India McKinsey report titled. How will the vaccine be funded? 7. and political concerns and is not just a technical one.7 billion by 2020. II. “India Pharma 2020: Propelling access and acceptance. primarily from the private sector. and therefore has considerable bearing on global vaccine pricing. Is immunization the best control strategy for this disease? 3. and III trials and must submit their results to NRA for its approval. The Drug Technology Advisory Board (DATB) approves introduction of vaccines into the immunization services. perceptions.” As rightly stated in the WHO report on Vaccine Introduction Guidelines. The state licensing authority inspects and grants licensing for retail. What will be the net impact of the vaccine? 5. Table 7: A framework for decision-making on new vaccines: set of questions 1. It is the responsibility of the National Regulatory Authority (NRA) to ensure that only safe products are licensed. How will the addition of the new vaccine be implemented? Source: Assessing new vaccines for national immunization programmes. the decision to add a new vaccine to an immunization programme is often influenced by social values. while all vaccine approvals and clinical trials are by the CLAA. A rational decision on a vaccine requires information on: disease burden. where the private segment accounts for two-thirds of the total. McKinsey expects the market to grow to US$ 1. the vaccine manufacturer should conduct the phase I. vaccine safety and effectiveness. Till recently. both public and private sector vaccine producers were supplying vaccines to UIP. 2. For licensing of a new vaccine. “India is a major producer and exporter of vaccines: approximately 43% of global vaccine supply is provided by Indian manufacturers.

5 Pentavac . The decision to include a new vaccine in national schedule is not straight-forward as there are numerous issues in prioritizing investments of an immunization programme. Value(Rs. Although inclusion of a new vaccine in national schedule adds the cost of vaccine and logistics to the health budget of a country. improvements to existing vaccines. WHO 2005 The decision to include a new vaccine should be guided by the disease burden in the country. it also results in savings by reduction of the disease burden. 15 Section 2: Vaccination Market and Strategic Approach for India 6 . Table 9: Vaccine development and status Currently Available Vaccine Japanese encephalitis Hepatitis A Hepatitis B Hib Cholera Typhoid Varicella Mumps Rubella Influenza Combination Vaccine (Available) DTP-HepB DTP-Hib DTP-HepB-Hib Hib-HepB Measles-mumps-rubella Measles-rubella Under Development (New Vaccine) Pneumococcus (conjugate) – available in the US Meningococcus (conjugate) – available in the UK Respiratory Syncytial Virus Shigella HIV/AIDS Malaria Dengue Rotavirus Influenza (live.000) for new vaccines and infrastructure development.DPT MSD GSK Serum Institute GSK Panacea Biotech Ranbaxy Serum Institute Bharat Biotech Serum Institute Shantha Biotech 10/2008 07/2008 10/2008 02/2009 07/2008 10/2009 11/2008 02/2009 11/2009 09/2008 Company Launch Date Value(Rs. Table 8: Indian Vaccine Market: Top 10 New Introductions NIs Vaccine Market Gardasil Rotarix Pentavac Cervarix Polprotec Xprab Quadrovax Comvac. The GAVI partners have created the Global Fund for Children’s Vaccines to fund poorer countries (annual per capita income less than US$1. the Global Alliance for Vaccines and Immunization was formed in 1999 to accelerate new vaccine introduction.SD Shan HIB.Indian Immunization Programme A Literature Review In this direction. and combination vaccines. Cr) 79 16 11 12 10 7 3 3 2 1 Source: IMS-Health – June 2010 MAT Immunization Focus World Health Organization Regional Office report said that many new vaccines are available now and even more will be over the next decade. intranasal) Source: Assessing new vaccines for national immunization programmes. They include vaccines for diseases not previously immunized against. These issues need to be tackled systematically. Cr) 104 22 21 16 11 9 7 4 3 2 2 Incr. providing best possible immunization schedule as per the needs and resources of the country.

• Affordability and financial sustainability of the vaccination program. Advocacy and communication efforts are as important for community acceptance of the new vaccine as also for maintaining their confidence in the existing vaccines. - Although it is recommended that each issue is addressed in a fully informed decision-making process. The Flowchart outlines the key issues to be considered before deciding to introduce a vaccine. even if the initial introduction is supported by the external funding agency.Indian Immunization Programme A Literature Review Table 10: Criterion for selection while introducing a new vaccine in UIP The below given criteria considered for an informed decision making about the introduction of new vaccine in UIP: • Disease burden (incidence/prevalence. • The cost effectiveness of the vaccination programme and also of the alternatives other than vaccination. Source: National Vaccine Policy April 2011 by Ministry of Health & Family Welfare Section 2: Vaccination Market and Strategic Approach for India The potential inclusion of any new vaccine in UIP should initially be discussed by NTAGI. • Safety and efficacy of the vaccine under consideration. outlines the key issues to be considered before deciding to introduce a vaccine. some aspects of the flowchart may outweigh the other considerations. including cold chain capacity. According to WHO report on “Vaccine Introduction Guidelines – Adding a vaccine to a national immunization programme: decision and implementation” 2005 paper. epidemic/pandemic potential). The NTAGI may consider various factors before giving technical recommendation for introducing any new vaccine in the programme. This report aims to help country-level decision-makers decide whether to add a new vaccine to the national immunization programme and national immunization programme managers to implement the operational steps to add the vaccine. The technical decision of NTAGI should be considered by immunization division for implementation. 16 . examination of the key elements for programmatic planning and for monitoring the impact of the additional vaccine is required. • Availability of a domestic or external vaccine production capacity. depending on the specific circumstances. absolute number of morbidity/mortality. While deciding to introduce a vaccine. The emphasis is on two parametric issues: - Policy issues as first (where high level decision-makers to agree on whether the introduction of a particular vaccine is acceptable from an immunization policy perspective by doing assessment of public health priority and candidate vaccine) Second as Programmatic Issues (addressing the feasibility of the vaccine introduction from a technical perspective). • Programme capacity to introduce a new antigen.

advocacy and awareness programmes (IEC activities) is essential before finalizing introduction of the new vaccine. quality and safety Other inventions (including When deciding about the priority of a particular vaccine. Supply availability Programmatic strength Introduce the vaccine Wait for production Source: WHO 2005 Vaccine Introduction Guidelines Paper and Compilation by Imprimis Research The ‘Child Mortality Estimates Report 2012’ released by UNICEF in New York on September 2012 says almost 19. Economic and financial issues Cost analysis of new vaccine: The total cost (vaccine and logistics cost) is compared to the potential savings as a result of reduced treatment of the disease.Indian Immunization Programme A Literature Review Figure 8: Flowchart: Key Issues: Introduction of new vaccine Introduction of Vaccine X POLICY ISSUE – Assessment of public health priority and candidate vaccine ‘X’ Public health priority Disease burden The perception of the public/medical community about the vaccine and the disease is a significant factor to identify its introduction as a priority. PROGRAMMATIC ISSUES Vaccine presentation The proposed vaccine may be available as monovalent/combination. safe injection supplies and disposal. with the highest number of such deaths at 1. disability rate and mortality rate of the disease in question. single dose/multi dose and liquid/lyophilized while considering presentation/ formulation. Careful assessment of financial sustainability (over medium to long term) of the immunization programme after introduction of the new vaccine. The vaccine needs to be efficacious in preventing the disease in immunized individuals. but also in terms of annual hospitalizations. India tops the list of countries for 2011. The newer vaccines are often manufactured by a limited number of manufacturers and it takes some time to augment production following introduction of vaccine in national immunization programme. The disease burden is assessed not only in terms of incidence and prevalence.65 million. In developing countries especially. the future trend. Immunization is the most 17 Section 2: Vaccination Market and Strategic Approach for India . Introduced vaccine should meet international standards of quality and safety. staff training and supervision.000 children less than five years of age die every day across the world. which will result in steep decline in the child mortality rate. it is also important to other vaccines) consider other vaccines that are likely to be available in the near future. Efficacy. adequate staff. Careful assessment of requirement of additional cold chain capacity. required dose and post-marketing surveillance need to assessed before decision making. The Indian government – at the Centre and the states – need to put a lot of focus on improving health and nutritional among children. Here data on causative organism rather than clinical syndrome is needed.

funding. - There are considerable inequities in childhood vaccination by various individual (gender. We have seen two main coverage issues vis-à-vis the Indian Immunization Programme : - There is a high level of disparity in vaccination coverage in different states. One of the obvious reasons for this could be that the level of coverage with individual vaccines does not meet the target of sustained high coverage required to control/eradicate the disease. wealth.Indian Immunization Programme A Literature Review cost-effective public health intervention in India. World Health Statistics 2011 18 . however. The effective immunization coverage largely depends on political will. and societal (access to healthcare. parental education). The traditionally poor preforming states have greater inequities. family (area of residence. strategic initiative and execution of the planned policies. the burden of vaccine-preventable diseases remains unacceptably high. there is significant inequity even among better performing states. in comparison to developed nations and also many developing countries9 . Section 2: Vaccination Market and Strategic Approach for India Coverage of immunization is affected by demand and supply side factors highlighted well in CES 2009 report: Figure below Figure 9 Reasons for partial or no Immunization (multiple responses) Did not feel need Demand Side Issues Not knowing about vaccines Not knowing where to go for immunization Time not convenint Fear of side effects Do not have time Wrong advice by someone Cannot afford the cost Supply side Issues Vaccine not available Place not convenient ANM absent Long waiting time Place too far Service not available Others (n=9. Despite these achievements and tremendous advances in economic and technological spheres in recent years. Challenge and Strategic Action Points to Improve Immunization Coverage India was one of the first countries to adopt the World Health Organization’s Expanded Programme of Immunization (EPI). community literacy level) characteristics.2. social (religion. The programme began globally in 1974 and was initiated in India in 1978. considerable progress has been made in terms of reduction in disease burden. Since its inception. 2. .375) 05 Source: CES 2009 ___________________________________________________ 9 10 15 Percentage 20 25 30 World Health Organization. birth order). caste).

Karnataka. These are well presented in CES 2009 report (refer to the figure below) Figure 10: Full Immunization (%) – State-wise Achievement 87.78 .0 20.7 Himachal Pradesh Jammu & Kashmir Madhya Pradesh Mizoram Haryana Tripura West Bengal Maharashtra Karnataka Tamil Nadu Meghalaya Jharkhand Andhra Pradesh Chhattisgarh Rajasthan Figure 11: Immunization status among children of 12-23 months by states 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Jammu & Kashmir Delhi Uttarakhand UTs combined West Bengal Jharkhand Maharashtra Karnataka Tamil Nadu Himachal Pradesh Andhra Pradesh Meghalaya Chhattisgarh Rajasthan Madhya Pradesh Uttar Pradesh Nagaland Haryana Tripura Punjab Kerala INDIA Assam Arunachal Pradesh Goa Sikkim Mizoram Gujarat Manipur Orissa Bihar Full Immunization Partial Immunization No Immunization Source: CES 2009 Uttar Pradesh Uttarakhand Nagaland Kerala Assam Gujarat Goa Sikkim Punjab Delhi INDIA Manipur Orissa Bihar 0.0 66.9 100.0 10.6 78. Manipur.5 71. trend highlights that States like Goa.6 81. Himachal Pradesh. Rajasthan (15. Uttar Pradesh (17.0 42.0 90.6 66. High percentage of children left out from the vaccination programme (those children who received no immunization) was observed in Nagaland (31.8 73.5 59.8 51.0 40.0 60.6 %).9 2.Indian Immunization Programme A Literature Review Analyzing and studying the data given in CES 2009 mapped the state level immunization coverage.0 19 Section 2: Vaccination Market and Strategic Approach for India 71.3 75.0 70.1 57.0 30.7 59.7 71.0 50. Punjab.9 %).0 60.9 40.0 85.2 %) and Manipur (11. Tamil Nadu and Sikkim had more than 75 % full immunization coverage.3 83.8 %).9 49.6 %).8 59.5 68.0 80. Kerala.6 53.0 66. Arunachal Pradesh (25.7 %).5 78.9 61.3 56.0 70. Bihar (15.

NE States Bihar Establishing support groups Maharashtra Section 2: Vaccination Market and Strategic Approach for India Quality Assurance Network for training of health workers Outsourcing immunizations to NGOs in underserved areas Incentives to health worker/ families Rajasthan Engagement with PRI to mobilize beneficiaries and incentives for health workers Kerala. Bihar. Delhi Strengthening vaccine. Karnataka Punjab Kerala. Bihar. PPP with medical college and Chhattisgarh. Orissa Jharkhand. youth organizations Jharkhand. cold chain and logistics management Mobile Cold-Chain Workshop in Rajasthan Annual Maintenance Contract for cold chain Vaccine and logistics management assessment District level CES Partner supported monitoring Supportive supervision Rajasthan Tamil Nadu.) External quality assurance mechanism for health workers’ training Strategies to increase immunization in High Performing States Karnataka. MP State task force/operational core group for monitoring District level supervision Close monitoring. vaccine stock management systems Maharashtra.Indian Immunization Programme A Literature Review Table 11: Strategy pointer for High and Low Performing States Strategies to increase immunization in Low Performing States Catch up Campaigns – Immunization + other interventions (Vit A. cluster and internal evaluation. Karnataka Arunachal Pradesh Jharkhand. Delhi static and mobile clinics Private medical practitioners involvements. Maharashtra Bihar Orissa Strengthening programme monitoring and supervision Bihar. Karnataka. Jharkhand. outsourcing immunization to NGOs in underserved areas Emergency vaccine procurement fund. Goa. Deputy Commissioner (ID & Imm) Ministry of Health & Family Welfare. Maharashtra Divisional level reviews UP Source: Routine Immunization Presentation by Dr SD Khaparde. Gujarat UP. Deworming etc. Rajasthan. Tamil Nadu. Mizoram Strengthening service delivery UP. Orissa Operationalization of additional Mizoram. GOI 20 . AP (with Medical Colleges). and supportive supervision of low performing areas Kerala. Kerala.

ASHA Need for research policy planning unit Variable AVD mechanism Hard to reach area/migrant population High load of training Cold Chain Space Source: India’s Universal Immunization Programme Presentation by Anuradha Gupta at GAVI Alliance Board Meeting 13 June 2012. Indian Immunization Programme A Literature Review 21 Section 2: Vaccination Market and Strategic Approach for India .Table 12: National Immunization Programme – Issues and Challenges spectrum in India Human Resource Programme Monitoring Policy Issues VPD Surveillance Vaccine Safety Weak tracking mechanism Limited evidence for introduction of new vaccine Limited outcome monitoring Weak Laboratory Surveillance Patchy VPD surveillance data AEFI Apprehension in Community Logistics Limited capacity of PSUs Inadequate Programme Management structure at National. thereby increasing access to immunization. ANM. managerial capacity. Washington DC Considering India immunization programme is facing the above challenges at various levels. an optimal immunization policy would need to bring efficiencies in service delivery. State and District level Limited demand generation Few vaccine manufacturers Top down vaccine supply Vacant post of Medical officers. resource availability and maintenance.

000 ASHA workers in position for social mobilization National Vaccine Policy developed Action 4: Social Mobilization Efforts Action 5: Improving Public Confidence Action 6: Improving Logistics and Supply Chain Action 7: Evidence Generation Action 8: Policy Strengthening Vaccine Policy Unit being constituted for evidence collection and compilation for under-utilized and newer vaccine Revised Multi-year Plan (MYP) for UIP in India (2010-17) prepared Sentinel Hospital based Bacterial meningitis surveillance initiated with ICMR in 11 states Table 13: A year of Intensification of Routine immunization – 2012 – Strategic Approach To Improve Immunization Coverage Action 1: Health System Improvement Action2: Identifying the Unreached and conducting Immunization Week Decentralized planning and need based funding Exclusive immunization strategy for Migratory Population and Urban slums based on Polio Micro-plans Indian Immunization Programme A Literature Review Improving service delivery through: 2nd ANMs.Section 2: Vaccination Market and Strategic Approach for India 22 Action 3: Tracking Every Mother and Every Child Web-based Mother and Child Tracking System (MCTS) as one of the key strategies to prevent left out and drop outs AEFI operational guidelines revised Alternate Vaccine Delivery (AVD) forms the lifeline of the National Immunization Programme for vaccine delivery from the last cold chain storage point to session site Proposal to initiate Teeka Express Strengthening of National Integrated Disease Surveillance Programme for Vaccine Preventable Disease Scale-up of laboratory enhanced measles outbreak surveillance Polio Surveillance Network now being extended for surveillance of other Vaccine Preventable Diseases Name-based tracking of all pregnant mothers with contact details. including mobile number SMS alerts in local language regarding due date of vaccination for the child Advance preparation of village-wise due list for the scheduled immunization session using tracking bags Media sensitization and involvement in AEFI Improved reporting of serious AEFIs Also provides branding to the Immunization Programme Proposal to brand Routine Immunization Programme Capacity building of health care providers in causality assessment Specially designed vehicle to deliver vaccine at session site in hard-toreach areas ASHA incentive linked with mobilization and performance National and district AEFI committees constituted More than 860. mobile medical units Convergence of Polio and RI micro plan Immunization Technical support Unit (ITSU) to strengthen UIP Source: India’s Universal Immunization Programme Presentation by Anuradha Gupta at GAVI Alliance Board Meeting 13 June 2012. Washington DC . alternate vaccinators Special drive in the form of ‘Immunization Week’ developed for poor performing areas/ blocks to improve immunization coverage Cold Chain System strengthening Strengthening intersectoral co-ordination Intensified Session Monitoring Reaching the unreached – Teeka Express.

at a price they can afford. malaria and tuberculosis. train staff and build manufacturing facilities. • Prioritization of areas with exclusive strategy for 200 poor performing districts. The strategies that are being deployed under this include: • Updating of micro plans to cover all villages and hamlets in the country. Table 14: Advance Market Commitments – The new trend in Vaccination Industry A new approach to public health funding. The key objective of this campaign is to improve full immunization coverage and reach all children. WHO and UNICEF. participating companies also make binding commitments to supply the vaccines at lower and sustainable prices after the donor funds made available for the initial fixed price are used up. Pneumococcal disease takes the lives of 1. designed to accelerate access to vaccines against pneumococcal disease. particularly in remote. Advance Market Commitments (AMCs) are designed to stimulate the development and manufacture of vaccines specifically for developing countries. knowing that vaccines will be available in sufficient quantity. after two years of preparatory work.Indian Immunization Programme A Literature Review India has declared 2012 as the year of intensification of routine immunization. inaccessible and backward areas as well as in urban slums. • Deployment of adequate number of health workers. GAVI. today HIV/AIDS. It is estimated that this pilot project could prevent more than seven million childhood deaths by 2030. tuberculosis (TB). GlaxoSmithKline (GSK) and Pfizer Inc. New vaccines present numerous issues in prioritizing investments of a national immunization programme. As per WHO “Assessing new vaccines for national immunization programmes a framework to assist decision makers – 2005”. • Special immunization drives in pockets of low immunization coverage. The two participating firms committed to supply 30 million doses each year for a 10-year period. developing country governments are able to budget and plan for immunization programmes. The donor commitments provide vaccine makers with the incentive they need to invest the considerable sums required to conduct research.6 million people each year – including up to one million children before their fifth birthday. In June 2009. malaria. As part of the AMC. The present full immunization coverage of children is 61%. Ultimately. • IEC related activities for demand generation towards immunization. GAVI hopes to assist up to 60 of the world’s poorest countries to introduce these vaccines by 2015. respiratory and gastrointestinal infections form the bulk of infectious disease burden in developing countries. five national governments and the Bill & Melinda Gates Foundation signed legal documents to formally kick-off the first-ever AMC. Many of these infections are potentially vaccine-preventable and vaccine development studies are accelerating. The revolutionary new way of developing a vaccine is through Advance Market Commitment (AMC) (explained below). Lessons learnt from this first AMC will help in the planning of other AMCs to tackle diseases such as HIV/AIDS. for the long term. the World Bank. More than 90 % of these deaths occur in developing countries. . The pilot AMC is for a new vaccine to target pneumococcal disease. • Intensification of immunization activity by observing immunization weeks in low performing states. In March 2010. became the first two companies to make long-term commitments to supply new vaccines for the Pneumo AMC. Source: GAVI Alliance: Advance Market Commitment 23 Section 2: Vaccination Market and Strategic Approach for India • Special focus on migrant and mobile populations.

Section 2: Vaccination Market and Strategic Approach for India 2. Conclusion Understanding the literature and studying policies made by decision makers and stakeholders. In some cases no vaccine exists. we would like to highlight in a nutshell strategizes to increase immunization coverage. or enhancing distribution to the target population.3. New or improved vaccines for the following agents are currently under development. lowering costs. for which we need to: 24 . but in other cases vaccine development is directed towards improving efficacy.Indian Immunization Programme A Literature Review The development of vaccines ranks among the greatest achievements in medical history.

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2. the proportion of people without sustainable access to safe drinking water and basic sanitation By 2020. preferably by 2005.000 live births) Gross national income per capita (PPP. 6. proportion of population below national poverty line Halve. 2.804.000 25. 3. boys and girls alike. Appendix 2: WHO and UNICEF presents the country level data on immunization status.224. between 1990 and 2015. 9.org/content/india/en/home/mdgoverview/ 27 Section 3: Appendix and Reference ΔΔ . 8. Appendix 1: India’s progress on the MDGs for 2015 Target No. Indian factsheet for 2010 INDIA 2010 Birth Surviving infants Total population Infant mortality rate (per 1. USS) Percentage of routine EPI vaccines financed by government 27. 1. and in all levels of education no later than 2015 Reduce by two-thirds. 5.000 live births) Under-five mortality rate (per 1.Indian Immunization Programme A Literature Review 3. will be able to complete a full course of primary education Eliminate gender disparity in primary and secondary education. 4.614.undp. especially information and communication Progress Signs Δ Θ ΔΔ Δ ΘΔ ΘΔ Δ ΘΔ ΔΘ φ ΔΔ Source: UNDP in India website page – Millennium Development Goals10 Δ: Moderately/almost nearly on track considering all indicators Θ: Slow/almost off-track considering all indicators Δ Δ: On-track or fast considering all indicators 3. between 1990 and 2015. by 2015.000 1. 10. 7. the under-five mortality rate Reduce by three quarters.560 100 ___________________________________________________ 10 http://www. Target Description Halve. proportion of people who suffer from hunger Ensure that by 2015 children everywhere. to have achieved a significant improvement in the lives of at least 100 million slum dwellers In cooperation with the private sector. 12.000 48 63 3. make available the benefits of new technologies. 11. between 1990 and 2015.165.1. between 1990 and 2015. the maternal mortality ratio Have halted by 2015 and begun to reverse the spread of HIV/AIDS Have halted by 2015 and begun to reverse the incidence of malaria and other major diseases Integrate the principles of sustainable development into country policies and programmes and reverse the loss of environmental resources Halve.in.

Indian Immunization Programme A Literature Review National Coverage rates (%) (WHO/UNICEF estimates.10. 28 . 16-24 months. 16-24 months OPV TT birth. 6. pregnency target age group at 80% or above --------- Vitamin 9.16 years.14 weeks. 16-24 months 10. 5 years birth.36 months A Source: Immunization Summary compiled by UNICEF and WHO 2010 – A statistical reference data.30.24.14 weeks (subnational) 16-24 months (subnational) Messles 9-12.14 weeks.10. 6.18. 2010) 2010 BCG DTP1 DTP3 HepB3 Hib3 MCV Pol3 PAB 87 83 72 37 --74 70 87 2009 87 83 72 29 --74 70 86 2008 87 83 72 21 --74 70 86 2007 87 87 70 6 --74 69 86 2006 87 83 66 6 --70 67 88 2005 81 78 67 6 --64 55 86 2000 74 72 62 ----55 64 85 1995 81 88 71 ----72 71 83 1990 66 88 70 ----56 66 81 1985 8 41 18 ----1 14 49 2010 Number of districts in country Percentage of districts reporting below 50% 644 0 --------between 50-60% at 80% or above MCV: proportion ofdistricts with coverage at 90% or above (%) 1980 --25 6 ------2 20 2009 --------------- Measles control activities (as reported) Section 3: Appendix and Reference DTP3: proportion of districts with coverage (%) DTP1-DTP3 drop-out rate: proportion of districts that have achieved a rate of less that 10% --(%) Measles control activities (as reported) MCV2 routine coverage in 2010 (%) year Most recent national measles campaign Immunization schedule DCG DTwP HopB JG birth 6.10.

96 99* 99* 99* 95 88 84 3 50 69 72 68 78 98 94 90 87 82 70 64 94 93 90 93 92 91 95 93 90 90 99* 99* 93 97 85 99* 87 78 97 77 71 74 58 53 90 81 73 99* 99 91 99* 98 97 99* 97 96 93 99* 99* 97 95 77 47 37 30 28 12 8 Vaccines 2010 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1993 1992 1991 1990 1989 1988 1987 1986 1985 1984 1983 1982 1981 1980 BCG(Bacille Calmette Guérin vaccine) 96 97 DTP1 (First dose of diphtheria toxoid. tetanus toxoid and pertussis vaccine) 94 96 DTP3 7 (Third dose of diphtheria toxoid.3. Appendix 3: India reported immunization coverage: Last update: 14-Jul-2012.3.5% YFV (Yellow fever vaccine) Source: WHO Vaccine-preventable Diseases: Monitoring System 2012 Global Summary Indian Immunization Programme A Literature Review 29 Section 3: Appendix and Reference . tetanus toxoid and pertussis vaccine) 90 97 HepB_BD (HepB birth dose) HepB3 (Third dose of hepatitis B vaccine) 91 34 Hib3 9 90 89 86 75 67 56 89 87 66 81 83 83 87 89 86 85 91 83 79 (Third dose of Haemophilus influenza type B vaccine) 90 68 1 JapEnc (Japanese Encephalitis) 37 MCV (Measles-containing vaccine) 87 94 99* 94 MCV2 (Measles-containing dose) vaccine 2nd PCV1 90 88 82 70 70 95 93 90 94 93 92 95 94 91 (Pneumococcal Conjugate 1st dose) 91 99* 99* 88 83 73 94 82 99* 87 99* 42 PCV3 (Pneumococcal Conjugate 3rd dose) Pol3 (Third dose of polio vaccine) 90 99* 88 99* 94 Rota1 (Rotavirus 1st dose) Rota_last (Rotavirus last dose) 99 56 85 84 79 56 47 43 83 78 78 73 69 86 76 80 80 80 75 77 81 82 79 78 78 59 65 57 45 40 35 31 30 24 22 Rubella1 (First dose of Rubella vaccine) TT2+ (Second and subsequent doses of tetanus toxoid) 79 80 VAD1 (Vitamin A doses (VAD1) by 12 months) 88 84 * indicates coverage was reported over 99.

with measles First vaccine use: 2 dose Revaccinate annualy: 1 dose only (see footnote) Source: WHO recommendations for routine immunization – summary tables 30 . 2 Minimum age doses adult/children > 6yrs.Indian Immunization Programme A Literature Review 3. with measles 13 Adolescents Adults Considerations (see footnotes for details) Vaccine options Recommendations for certain regions Japanese Encephalitis11 Mouse brainderived vaccine: booster every 3 years up to 10-15 years of age Yellow fever12 Tick-Borne Encephalitis Co-administration Section 3: Appendix and Reference 3 doses (> 1 yr FSME-Immun and Encepur. booster every 2nd year.4. booster every 6 months. booster dose after 2 yrs MenA conjugate 1 dose (1-29 years) 2 dose (2-11 months) with booster 1 year after 1 dose (≥ 12 months) 2 dose (9-23 months) 1 dose (≥ 2 years) 2 doses 3 doses Definition of high-risk Definition of high-risk. Ty21a live oral vaccine: 3-4 doses. Booster dose 3-7 years after primary series Definition of high-risk Vaccine option Recommendations for some high-risk populations Typhoid14 Cholera15 Dukoral (WC-rBs): 3 doses ≥ 2-5 yrs. Revaccinate annualty (see footnote) Priority targets Definition of highrisk Lower dosage for children Definition of high-risk. Booster Coverage criteria>80% Combination vaccine 1 dose from 9 yrs of age. Vaccine option Meningococcal16 MenC conjugate Quardrivelent conjugate Hepatitis A17 Rabies 18 Recommendations for immunization programmes with certain characteristics Mumps19 Influenza (inactivated)20 2 doses. Timing of booster Vi polysaccharide vaccine: 1 dose. Booster Definition of high-risk dose 3-7 years after primary series Vaccine option.> 3-4 doses. Appendix 4: Summary of WHO position papers – Recommendations for Routine Immunization (updated 31 May 2012) Antigen Children (see table 2 for details) Live attenuated vaccine: 1 dose booster after 1 year Mouse brain-derived vaccine: 2 doses booster after 1 year then every 3 years 1 dose. Shanchol Definition of high-risk & mORCVAX: 2 doses ≥ 1 yrs.

Figure 2: Global Total Mortality in Children under 5 years Figure 3: Millennium Development Goals – The Eight Goals for 2015 Figure 4: Immunization coverage – CES 2009 Figure 5: Immunization among children % of 12-23 months Figure 6: Public Expenditure allocation – Centre and State Figure 7: Healthcare spending by Government in India Figure 8: Flowchart: Key Issues: Introduction of new vaccine Figure 9: Reasons for partial or no Immunization Figure 10: Full Immunization (%) – State-wise Achievement Figure 11: Immunization status among children of 12-23 months by states Frequently Used Abbreviations GoI UNICEF UNDP UNFPA WHO NRA MoHFW NRHM MDG GAVI GIVS GFCV AVI ADB EPI UPI FYP MYP CSSM RCH NFHS DLHS CES Government of India United Nations Children’s Fund United Nations Development Programme United Nations Population Fund World Health Organization National Regulatory Authority Ministry of Health & Family Welfare National Rural Health Mission Millennium Development Goals Global Alliance for Vaccines and Immunization Alliance Global Immunization Vision and Strategy Global Fund for Children’s Vaccines Asian Vaccination Initiative Asian Development Bank Expanded Programme on Immunization Universal Immunization Programme Five Year Plan Multi Year Plan Child Survival and State Motherhood Reproductive and Child Health National Family Health Survey District Level Household Survey Coverage Evaluation Survey UHC GDP ORT DCGI CDSCO CLAA NTAGI DATB GCP ICMR VPD AVD BCG DTP PSUs ASHAs AEFI ITSU MCTS AMC IEC Universal Health Coverage Gross Domestic Product Oral Rehydration Therapy Drugs Controller General of India Central Drugs and Standards Control Organization Central Licensing Approval Authority National Technical Advisory Group on Immunization Drug Technology Advisory Board Good Clinical Practice Indian Council of Medical Research Vaccine Preventable Diseases Alternate Vaccine Delivery Bacille Calmette Guérin Vaccine Diphtheria Toxoid.Indian Immunization Programme A Literature Review Tables and Figures Index Tables Table 1: Quick Facts: Immunization Table 2: Child Health Programme in India: 1950-2012 Table 3 : WHO recommends National Immunization Schedule for India Table 4: Regression model analysis stating factors and their relationship with Immunization Table 5: Global and International Organizations Table 6: Authorities at work on Vaccination and Immunization in India Table 7: A framework for decision-making on new vaccines: set of questions Table 8: Indian Vaccine Market: Top 10 New Introductions Table 9: Vaccine development and status Table 10: Criterion for selection while introducing a new vaccine in UIP Table 11: Strategy pointer for High and Low Performing States Table 12: National Immunization Programme – Issues and Challenges Spectrum in India Table 13: A year of Intensification of Routine Immunization : 2012 – Strategic Approach To Improve Immunization Coverage Table 14: Advance Market Commitments – The new trend in Vaccination Industry Figures Figure 1: Vaccine preventable diseases: India reported cases (Year wise). Education and Communication 31 Section 3: Appendix and Reference . Tetanus Toxoid and Pertussis Vaccine Public Sector Units Accredited Social Health Activists Adverse Events Following Immunization Immunization Technical Support Unit Mother and Child Tracking System Advance Market Commitments Information.

WHO (December 2000) Assessing New Vaccines for National Immunization Programmes.who. 2012: Year of Intensification of Routine Immunization in the South-East Asia Region: Framework for increasing and sustaining coverage. Working Paper No: 2012-100. State of the world’s vaccines and immunization. 2011 15. regional.asp Section 3: Appendix and Reference 32 . New Delhi – August 2006 28. IIMA Working Papers WP200406-08 12.unicef. http://kotharionindia. WHO vaccine-preventable diseases: monitoring system 2012 global summary 36. Anuradha Gupta. (http://www.2007-08. (The International Bank for Reconstruction and Development / The World Bank) 6. Regional Committee document. UNICEF: Coverage Evaluation Survey Report 2009 (CES-2009): All India Report 20.who. 18. Deputy Commissioner & Pubic Health Expert Child Health & Immunization Ministry of Health & Family Welfare. Global. Govinda Rao and Mita Choudhury. Ministry of Health & Family Welfare. 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Dr SD Khaparde Deputy Commissioner (ID & Imm) Ministry of Health & Family Welfare. http://www. Health Care Financing Reforms in India.org/immunization/files/SOWVI_full_report_ english_LR1. Igor Rudan. Colin Mathers. Robert E Black.int/entity/gho/publications/world_health_ statistics/EN_WHS2011_Full. Economic Research Foundation.pdf 52.unicef. 29. Immunisation (2005).in.undp.18. Ajay Tandon and Cheryl Cashin (2010). Government of India. WHO (2005) – Vaccine Introduction Guidelines – Adding a vaccine to a national immunization programme: decision and implementation 27. India. Analysis of Public Expenditure on Health Using State Level Data. India Pharma 2020: Propelling access and acceptance. http://www. and national causes of child mortality in. WHO (http://www.org/vision/in_financing/amcs/index. Dept. WHO. 40. 24. UNICF/WHO. Harry Campbell. Government of India 7.. 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