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The Vaccine Policy in India: An Assessment

Vaccines: A vaccine is a biological preparation that improves immunity to a particular disease. It typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins. The agent stimulates the body's immune system to recognize the agent as foreign, destroy it, and "remember" it, so that the immune system can more easily recognize and destroy any of these microorganisms that it later encounters. Types: Killed Attenuated Toxoid Subunit Conjugate Experimental Valence

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Vaccines are vital preventive medicines for primary health care, and are a significant component of a nations health security. The success of immunization program in any country depends more upon local realities and national policies, than any outward assistance. Factors governing efficacy of a vaccine: The disease itself The strain of vaccine Whether one kept to the timetable for the vaccinations Some individuals are "non-responders" to certain vaccines, meaning that they do not generate antibodies even after being vaccinated correctly Other factors such as ethnicity, age, or genetic predisposition

Vaccine policy in India: Following are the key features of the vaccine policy in India: The current Indian market for vaccines is estimated to be about US $260 million. India is among the main buyers and manufacturers of vaccines, locally as well as globally, and has traditionally intended at self-reliance in vaccine technologies and production. The countrys vaccination modules go by innumerable names, as part of a global program to achieve 100% immunization for 22 diseases by 2015. Approximately 43% of global vaccine supply is provided by Indian manufacturers, primarily from the private sector. Vaccine related projects are currently being implemented in Indian Council of Medical Research (ICMR), Department of Science and Technology (DST), Council for Scientific and Industrial Research (CSIR), small and medium vaccine industries, medical and engineering schools, in addition to the Department of Biotechnology (DBT) supported autonomous institutions.

The guidelines on the policy, widely disseminated amongst policy makers and program managers will be utilized for the drafting of the strategies and operational plans. It is a key document which will be utilized for harmonizing other policy and planning document and has the following features:

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For each area, a number of monitoring indicators will be prepared and progress on this document will be monitored accordingly. This will include a summary of progress, identified areas where progress is lagging, and proposals on corrective actions, where needed.

There are multiple stakeholders, including national and state governments and development partners, in immunization program in India. The Union and state governments are involved in all aspects of program while the role of development partners are most often involved in providing technical assistance and support, rather than direct implementation.

While the policy implementation will be monitored on the regular basis, this policy will be reviewed after periodic intervals, allowing changes to be made, which respond to the reality of then health policy environment in the country.

Current Trends in vaccine development: Until recently, most vaccines were aimed at infants and children, but adolescents and adults are increasingly being targeted Combinations of vaccines are becoming more common New methods of administering vaccines are being developed, such as skin patches, aerosols via inhalation devices, and eating genetically engineered plants Vaccines are being designed to stimulate innate immune responses, as well as adaptive Attempts are being made to develop vaccines to help cure chronic infections, as opposed to preventing disease Vaccines are being developed to defend against bioterrorist attacks such as anthrax, plague, and smallpox Appreciation for sex and pregnancy differences in vaccine responses "might change the strategies used by public health officials" Polarised positions: The experts and the community, by their particular locations, differ on experience, perceptions, attitudes, and challenges. The absence, in the public domain, of information, evidence and policies, and the lack of transparency in decision making make it difficult for a rational and robust defense of either stand. Complex issues and challenges involved:

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Having compulsory vaccinations is connected with difficult policy issues where health authorities try to balance health of society and individual liberty. Such concerns arise because vaccines differ from other medical interventions, as it involves healthy individuals being immunised to achieve a protective public health benefit. The public, empowered by the internet and sophisticated social media, wants answers to their concerns. Their questions include safety, schedules, affordability, relevance, benefits, risks and funding. Several factors drive public anxiety: poor immunisation coverage of established inexpensive vaccines push for newer expensive products, perceptions about the vaccine industry conflicts of interest among decision makers perceived pressures on institutions responsible for public policy scepticism about scientific truths and perceived risks

The controversies and adversities related to vaccine development in India can be attributed to following reasons: Adverse effects: Vaccines programs despite being very safe and having adverse effects in only rare situations are not able to be defended robustly by the government due to unavailability of systematic data collection. Deaths: The denial of problems and post-hoc compensation for such tragedies put the whole programme at risk resulting into far-reaching changes in policy and practice. Irregular Vaccine supply: The sudden forced stoppage of essential vaccine production by government manufacturing facilities driven by squabbling among politicians, civil servants and experts results in massive disruption to immunisation schedules and programmes and results in public distrust in the concerned Authorities. Role of private players: Public views with scepticism the role of private players in the vaccine industry especially in wake of expensive vaccines offered with limited protection (e.g. pneumococcal vaccine) for uncommon disorders. International involvement: Many international financial institutions are more than willing to fund vaccine programmes. However, their focus tends to be on the newer and more expensive vaccines and

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for pre-production and monopolistic pricing arrangements. The high prices, often out of reach of poorer nations, make such ventures suspect. Failed pandemic: The failure of several diseases to materialize like the swine flu pandemic, after the initial hype and scare, played into the hands of the vaccine and pharmaceutical industry, which bagged massive contracts. Unethical trials: Issues related to conflicts of interests and unethical nature of informed consent and recruitment procedures highlight a callous approach of industry, non-governmental organisations and health authorities. International disagreements: International disagreements time and again add to public concerns.

Considerations in the effectiveness of a vaccination program: Careful modelling to anticipate the impact that an immunization campaign will have on the epidemiology of the disease in the medium to long term Effective surveillance for the relevant disease following introduction of a new vaccine and Maintaining high immunization rates, even when a disease has become rare.

Barriers to strengthen Immunization Programme in India: Following are the well recognized challenges in the implementation of immunization program in the country: A number of vaccines used in National Immunization Programs (NIPs) in many developing and developed countries are not included in our vaccination programme due to factors like Delayed decisions to introduce them; Limited production capacity; Sometimes vaccines are not indigenously produced or not available in sufficient quantity. The diseases which are prevalent in India are often different than the ones in developed countries. However, till last decade majority of the vaccine research was being done in developed countries and the focus was on the vaccines against diseases, which are prevalent in developed country setting. Weak VPD surveillance system. Lack of data on disease burden in India and resulting perception that the disease is not important public health problem.

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Lack of diagnostic tools for certain vaccine preventable diseases that could be used without sophisticated instruments or specialized training.

Lack of baseline surveillance data also is a bottleneck in monitoring the impact of vaccination. Limited economic evaluations to show cost effectiveness of vaccines over other interventions to support decision-making.

Lack of a financial sustainability plan for the introduction of new vaccines in the UIP also affects decision making in this area.

Shortage of trained manpower to manage the UIP at the Center as well as State levels, for innovations in vaccines, for disease surveillance and for procurement and effective vaccine management.

Moving forward Traditional hierarchies, accepted for centuries, are being challenged in this new context and age. Increased cynicism and suspicion of authority is here to stay. Consequently, health establishments cannot dictate; they need to negotiate with communities and convince them of the need, rationale, efficacy and cost benefit of newer vaccine policies. Following suggestions can be made in this regard: There is an urgent need to establish sentinel centres in order to determine the prevalence of the diseases and conduct large-scale trials to assess impact. A detailed cost-benefit analysis from a public health perspective is mandatory for policy-making. The restoration of public trust, is essential for sustained vaccine coverage. Engagement with stakeholders and local politics, transparency in decision making, discussing uncertainties about risks and enhancing local ownership are crucial. There is a need for rigorous research to establish need, effectiveness and cost-benefit and for greater efforts at understanding factors that determine public trust. National policies need to be relevant, valid, accountable and participatory. The authorities should use innovative financing, funding and assured supply mechanisms. There is need for investing more on the research for the vaccines for the priority diseases in the country. Such

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research can be promoted only when there is conducive environment, funding and subsequent chances of vaccine being introduced in the National program. India should be able to ensure quality, safety, and efficacy of all vaccines that are either indigenously produced or imported for the use in the country. There should be a robust regulatory mechanism in place. Furthermore, the implementation of immunization program should be put in the perspective of broader goals of National Health Policy. There are a number of diseases, for which vaccines exists for long (Typhoid, Rubella), which may further be considered for the introduction in NIP in India. The country need to build upon the available investigator initiated research, modelling data, and systematic reviews to assess the disease burden. The institutional capacity building should be done for conducting demonstration projects and impact studies in the country. Most of the EPI vaccines procured for use in India comes from manufacturers that are not WHO prequalified and have different risk taking ability. Adhering to the WHO-UNICEF prequalification standards will enable more domestic manufacturers to cater to international markets. There is a need to set up systems for fast-track clearance of vaccines needed for emergencies. Clinical trials should be planned and executed according to the Good Clinical Practices (GCP) guidelines and maintain highest standards possible. GCP training courses should be mandatory for all PIs leading clinical trials. Strengthening Indian patent office, reducing the time to examine and grant a patent, and creation of more comprehensive IP databases in India. Reducing the lead-time to obtain regulatory clearances during vaccine development. In case of requirement of a new vaccine, the mechanisms like SBIRI and NMITLI should provide part support as loan on soft interest rate and part as grant just as was done in case of development of H1N1 vaccines. Local manufacturers must be encouraged to comply with WHO GMP standards. They may be assured with accurate demand estimates, followed by purchases of all ordered vaccines.

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The public sector units should be lead by a person with strong scientific background and should have a forward-looking corporate like governing system.

The pricing policy on vaccines should be based on a realistic assessment to retain the interest of the vaccine industry in research on the new vaccines. The Public sector industry should be revived to provide vaccines that have very low profit margins and to make these units competitive, they should be able to hire global consultants through appropriate mechanisms and be allowed to hire key personnel through market competitive rates.

A financial sustainability plan (FSP) for immunization should be created. The FSP should include the breakdown of vaccine and non-vaccine expenditures (system costs) and plan for scale up in the coming years. It should also factor in the changes to be brought about by the introduction of new vaccines, expansion in cold chain capacities and management.

The non-vaccine expenditure should also include expansion and sustenance of trained human resource.

Public health benefits of vaccines in the mass immunization programs should always outweigh the adverse effects. The economic burden and inconvenience to the parents/family should always be factored in when planning.

Studies that compare the burden to benefits ratio of vaccination to other options available for prevention should be encouraged.

There are several models for financing of vaccination for the impoverished other than government funds e.g. Typhoid vaccines in Pakistan, where the rich kids pay a price for the vaccine that allows it to be subsidized to the poor kids. In Bangladesh, the fishery industry finances the cholera vaccine for the poor. Such models need to be studied and similar ones to be developed for India at least for some vaccines such as pneumococcal conjugate vaccine, rotavirus vaccine and HPV vaccine.

The current regulatory guidelines followed by the NRA for vaccines are dated and essentially designed for the drugs. There is an urgent need to develop vaccine specific guidelines.

The continuous inputs needed to and from the repositories, largely set up in public sector institutes and platforms available with Indian Institutes of Technology (IITs), research institutes and universities, is largely missing. There should be robust mechanisms in place to integrate these partnerships in PPPmode.

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The bio-repositories need to be equipped with fingerprinting, sequencing for analysis of the genetic makeup of the organism, and freeze-drying facility for long-term storage.

Conclusion Indias strong and growing vaccine manufacturing sector and a rapidly rising global demand in vaccine R&D is also a tremendous economic opportunity. A number of linkages need to be explored between academia, industry and international institutions such as NIH/NIAID, Gates Foundation, GAVI Alliance, PATH, WHO and the International Centre for Genetic Engineering and Biotechnology (ICGEB). The Indian government should vigorously encourage independent policy research, cost-benefit studies, and wider national consultations on various phases of vaccination and public health so that it can take more informed choices on such matters. A proper strategy involving contributions from both public and private sector need to be formulated and implemented on a case-by-case basis to make safe and effective vaccines available at affordable prices. India can no longer ignore the lapses in this crucial aspect of national health, the limited data and the poor systems of information gathering, which do not allow for monitoring, generating evidence and rational policies. It is hence required to make sure that there occurs a regular communication, dialogue and engagement with all stakeholders which are crucial to building public trust, mandatory for successful vaccine programmes, and call for a revolution in policy-making.

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