The Universal Immunisation Programme in India

The initiative

In 1978, the GoI launched the Expanded Programme for Immunisation (EPI) in an attempt to cover recommended vaccines for all Indian children. The initiative was renamed as the Universal Immunisation programme (UIP) in 1985, at which time it extended six basic vaccines to all infants and the tetanus vaccine to pregnant women, and the immunisation schedule was changed to include measles and to drop the typhoid vaccine that had previously been covered.

In 2006, hepatitis B and Japanese encephalitis vaccines were also introduced in some parts of the country. Overall, the following vaccines were provided under UIP:

• BCG (for TB)
• DPT (Diphtheria, Pertussis and Tetanus Toxoid)
• OPV (Oral Polio Vaccine)
• Measles
• Hepatitis B
• TT (Tetanus Toxoid)
• JE vaccination (in selected high disease burden districts)
• Hib, containing Pentavalent vaccine (DPT+HepB+Hib) in selected states.[4]

The evolution of the UIP and related initiatives included the following major events:

• “1978: Expanded Programme of Immunisation (EPI)
• “1985: Universal Immunisation Programme (UIP)

  • For reduction of mortality and morbidity due to 6 VPD's
  • Indigenous vaccine production capacity enhanced
  • Cold chain established
  • Phased implementation - all districts [to be] covered by 1989-90
  • Monitoring and evaluation system implemented

• “1986: Technology Mission on Immunisation
• “1992: Child Survival and Safe Motherhood (CSSM)
• “1997: Reproductive Child Health (RCH 1)
• “2005: National Rural Health Mission (NRHM).”[5]

The challenge

At the time of India's independence in 1947, the country was reporting the largest number of smallpox cases in the world. Tuberculosis (TB) was also perceived as a major cause of morbidity and mortality. In May 1948, the Government of India (GoI) issued a press note stating that TB was reaching "epidemic proportions" and decided to introduce BCG (Bacillus Calmette Guerin) vaccination on a limited scale and strict supervision to control the disease. Although the efficacy of the vaccine in preventing pulmonary TB was in question, it was the only protective measure available at the time.[1]

Despite becoming a leading producer and exporter of vaccines, India was home to one-third of the world's unimmunised children, and before the 1990s fewer than half of the children in the country were vaccinated. There were several causes of this vaccine deficit:

• Insufficient government investment;
• A focus on polio eradication at the expense of other immunisations;
• Low demand caused by poor education of the population on the topic;
• The presence of anti-vaccine advocates.[2]

The lack of a quality supply chain and efficient logistics system also led to the waste of vaccines. Over 25% of the vaccines went to waste before reaching doctors and their patients, while others lost their efficacy by the time they were administered, according to reports. This posed a major challenge for the government and public health agencies that were working to expand the immunisation coverage, especially in remote areas of the country where supply chain logistics and infrastructure were in poor shape.[3]

The public impact

The UIP and other immunisation initiatives in India have achieved some positive impact over the last 40-plus years. However, results have been somewhat limited and spread unevenly across the country:

• In 2011, the UIP was targeting 27 million infants and pregnant women every year. However, immunisation rates through the national programme were uneven across the 28 (now 29) Indian states. The proportion of under-fives who were vaccinated exceeded 70% in only 11 states, and dropped below 53% in the 8 most populous states.[6]
• The National Family Health Survey (NFHS) III, which was conducted in 2005-2006, showed that between 1998-99 and 2005-06 there was only a marginal improvement at the national level of fully immunised children - from 42% to 44%. In addition to this relative stagnation at the national level, in some of the best performing states the coverage of fully immunised children actually went down. Since the launch of RCH II/NRHM in 2005, the reported rate of fully immunised children increased from 43% in 2002-2004 to 54% in 2007-2008.[7]
• Similarly, UNICEF's 2009-10 Coverage Evaluation Survey found that childhood vaccination coverage in India had improved little during the two decades from 1990 to 2010.[8]  The survey reported that “16 of 29 states had complete vaccination rates higher than the national average of 61.0%; the Union Territories combined together had 71.3% complete vaccination. Four states had greater than 80% complete vaccination.”[9]

Stakeholder engagement

Political commitment

India had been struggling with high infant mortality for years, so the GoI had strong incentives to support health initiatives in the country. It was the first country to join the WHO's EPI, and facilitated the evolution of the UIP over several years, adding new features and vaccines to the programme.

In 1988, a few years after UIP was launched, the GoI committed the nation to the target of global polio eradication, along with all 192 member nations of the WHO.[11] Similarly, the prime minister of India at the time, Rajiv Gandhi, established the goal of universal immunisation by 1990 as a "living memorial" to his mother, the late Indira Gandhi.[12]

There were also comprehensive efforts in place to improve the health infrastructure in the country, which were key to optimising the implementation of UIP. The NRHM was launched in 2005 to revitalise primary healthcare systems for the benefit of the people living in rural areas, particularly in difficult, inaccessible and remote parts of the country. More than USD15 billion have been allocated to states since the launch of that programme for strengthening health systems and infrastructure, with a key focus on reproductive and child health, including immunisation.[13]

Public confidence

One of the general challenges of the programme has been the availability of good information. The public has never been made fully aware of vaccine's availability and effectiveness nor of the immunisation schedule in their community, nor sometimes even of the immunisation sites in their own villages. The public has also feared the adverse impact of the vaccines on children, due to scepticism about the GOI's real intentions for the programme.

Some of the challenges of the UPI cited at the community level have included:

• Poor community participation
• Parents' lack of awareness of the immunisation benefits, schedules and locations
• Inconvenient timings of vaccination for many people (during working hours)
• The perception that the programme was independent of other healthcare initiatives.[14]

In addition, India has faced widespread distrust over the government's objectives relating to vaccination. It was believed by many, for example, that the polio drops for children led to their sterilisation. “Many Indians have feared forced sterilisation, since it was carried out during the authoritarian period of the late Prime Minister Indira Gandhi's state of emergency in 1975. Since then, government health initiatives have often been viewed warily… the impression from the illiterate and semiliterate is that anything from the present government would be to their detriment.''[15]

Clarity of objectives

The UIP had clearly stated objectives, which have been reviewed over time to address changes in circumstance. The features of the programme have also evolved to include more vaccines and services, in response to the rising needs of the initiative. The originally stated objectives of UIP were to:

• “Rapidly increase immunisation coverage
• “Improve the quality of services
• “Establish a reliable cold chain system to the health facility level
• “Introduce a district-wise [sic] system for monitoring of performance
• “Achieve self-sufficiency in vaccine production.”[16]

Strength of evidence

There is limited information available on the data supporting the rollout of the initiative at its inception. However, the UIP was rolled out as an expansion of the previously operating EPI, and several other immunisation initiatives had been previously rolled out in other countries with relative success.[17]

In addition, the UIP is connected to ITSU, a unit which operates as a link for translating scientific evidence into immunisation policy. This unit collates and synthesises evidence to inform the introduction of new vaccines and changes to the UIP. “The unit supports evidence generation on epidemiology of Vaccine Preventable Diseases and programmatic aspects of UIP such as programme performance and impact evaluation. In its capacity as the secretariat to the National Technical Advisory Group on Immunisation (NTAGI), the unit has worked to strengthen the immunisation policy formulation process at the NTAGI and its Standing Technical Sub-Committee. Recommendations from the NTAGI help inform decision-making for immunisation policy within the UIP. An active and functional secretariat has provided a vital boost to immunisation policymaking and accelerated several immunisation programme decisions such as the nationwide rollout of the Pentavalent vaccine and the introduction of vaccines against Rotavirus, IPV and Rubella in the UIP.”[18]

Feasibility

There were significant resource challenges reported around the programme, which limited its capability to operate effectively across the country.

There are several accounts of insufficient funding available from the GoI to support the sector appropriately, from both the distribution and manufacturing perspectives. “[The] immunisation programme needs better support and funding for conducting operational research to address programmatic issues and to improve coverage with all antigens in the UIP of India… The immunisation programme in India is a centrally funded programme. A good proportion of children are vaccinated with available and licensed non-UIP antigens. An increasing proportion of immunisation is being provided by the private sector and the proportion is likely to increase over the coming years”.[19]

This lack of funding also affects research into new vaccines. “A major challenge in vaccine production in India is the suboptimal investment by the public sector for vaccine research. The vaccine manufacturing units set in India are still producing some of the traditional vaccines and there appears to be a need for more funding and research on newer antigens. Indian manufacturers are participating in the development and clinical trials of a number of other candidate vaccines which would ensure that these vaccines are accessible to Indian population, as and when these become available.”[20]

Similarly, there are several areas that have been identified for improvement during reviews of the initiative.  Some of the major issues reported include:

• “Human resource gap
• “Lack of adequate health infrastructure
• “Poor microplanning, and immunisation sessions not being held regularly, in the community...
• “Low capacity to supervise, monitor, and implement micro-plan and feedback at district and health facility level...
• “Lack of proper supervision and monitoring, and delay in taking corrective measures in areas of concern at the government level
• “Failure to assess the programme in terms of outcome, i.e., incidence/prevalence of the disease (the GoI monitors programme success by the number of vaccine vials consumed)
• “Tendency to work independent of private/other agencies resulting in either duplication of effort or absence of services in some areas
• “Records not maintained properly and reporting are other major areas and the reported coverage is always much higher than the evaluated one
• “Low managerial and support capacity
• “[Limited] community participation.”[21]

Management

A programme like the UIP should be considered not only as a medical intervention but also as a programme requiring effective management. The managerial, administrative and governance-related aspects are critical to its success. "Structured work allocation and accountability needs to be set and monitored: from health worker level to the highest level. For example, a health worker should be allocated 100-150 babies and he/she should be responsible for immunisation (maybe along with delivery of other health services) of those children.”[22]

Insufficient management capacity is identified by many reviews as one of the programme's main weaknesses, including:

• “Inadequate delivery of health services (supply shortages, vacant staff positions, lack of training);
• "Lack of accountability, inadequate supervision and monitoring;
• "Lack of micro-planning at district level;
• "General lack of inter-sectoral coordination and lack of coordination between state and central governments, resulting in missed opportunities to improve immunisation coverage and quality.”[23]

The MoHFW is the agency responsible for the implementation of the programme across the country, but the management and monitoring was not very exhaustive at the initial stages of the programme, and there is limited information on how it is structured.

In 2001, the GoI established the NTAGI, which consists of experts from federal and state government, academic institutions, development partners, and professional organisations. To evaluate immunisation coverage, there are periodical population-based surveys. Any major immunisation decision is first discussed by the NTAGI and the recommendations it gives are then operationalised by the Programme Division within the MoHFW.[24]

Measurement

Although the UIP defined a set of indicators to monitor its progress, most reviews point out that the implementation of such controls has been poor, with several issues preventing a reliable measurement of progress. Lack of accountability amdinadequate supervision and monitoring are some of the reasons cited for missed opportunities to improve immunisation coverage and quality in the initial phase of the programme.

The UIP performs monitoring and evaluation at three levels:

• A regular reporting system from the health sub-centre to primary health centre, district, state and national level. “This reporting has been computerised in the country as a part of the Health Management Information System, and the data is available from health facility level and above every month.”[25]
• To evaluate immunisation coverage, the country conducts periodic population-based surveys. These include the NFHS, the District Level Health Survey, the Annual Health Survey and UNICEF's Coverage Evaluation Survey.
• In between periodic surveys and administrative reporting, there are also planned targeted studies and surveys to evaluate the performance of various components under UIP. [26]

There are also reviews carried out by independent bodies: “The UIP was independently reviewed, at least twice till 2000, first in 1989 and then in 1998, but no systematic effort was made during this period besides scattered activities and projects like the Immunisation Strengthening Project, the Border District Cluster Strategy, etc.”[27]

Alignment

There is a good framework within the country's health system to align stakeholders with immunisation goals - with some implementation weakness that have been previously discussed. The international community has also provided essential support for the initiative, while the country's private sector has been less committed.

The NRHM is one of the most significant healthcare programmes carried out in India, and has constituted a core support to the objectives of the immunisation initiative. There is an immunisation division as part of the RCH programme under the NRHM, which is itself located within the MoHFW. “This division provides all the technical assistance required to undertake the activities under the UIP. The division reviews the state programme implementation plans and facilitates in its approval process as per norms and guidelines. It facilitates the NTAGI to review and recommend its views on various technical and programmatic issues related to immunisation such as new vaccine introduction, etc."[28]

The UIP has also benefited greatly from international collaboration, with partners such as the WHO, UNICEF, and the Global Alliance for Vaccine and Immunisation (GAVI). For example, UNICEF has worked closely with the GoI on the UIP, focusing on fine-grained planning, cold chain logistics and advocacy and communication. It works with programme partners to build capacity, monitor, and evaluate programmes through the national office in New Delhi and its 15 field offices. UNICEF also helps coordinate various India-based partners and leading meetings between the MoHFW and partners like the WHO, the Bill and Melinda Gates Foundation, the Indian not-for-profit PATH, the Maternal and Child Health Programme (MCHIP), and the United Nations Office for Project Services (UNOPS). As an alliance partner, UNICEF supports GAVI through proposal development, the Annual Progress Report, and implementation. UNICEF is an active member of the NTAGI, the Immunisation Action Group, and the Polio Expert Advisory Group to support policy development.”[29]

Alignment with the private sector has been less strong, however, and its contribution has been widely criticised. According to some media outlets, private sector organisations have significant responsibility for the programme's failures, in that "the UIP has failed to meet its target, as efforts from the private sector in the initiative are meagre".[30] Representatives from the Department of Global Health, Boston University School of Public Health, the Indian Institute of Public Health, and the Public Health Foundation of India have strongly criticised the lack of private support saying: “The Indian government has urged an expanded role for the private sector to help achieve universal immunisation coverage”.[31] However, private contribution is limited, even though it has the potential to improve overall coverage significantly.

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