VACCINATION IN INDIA AND VACCINATION LAW

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ABSTRACT

The debate over whether vaccination should be made necessary by legislation is contentious, and it revolves around the certain rights of the community versus the rights of the individual, particularly their ability to make decisions in their best interests, introducing legislation to make vaccinations mandatory raises a slew of difficulties. Legal coercion may limit ability to choose what they believe is in their best interests. The question is whether obtaining herd immunity, and especially protecting individuals from deadly and preventable diseases, justifies compromising on their rights. The importance of legislation and case law in assessing whether it is in the best interests of an individual to be protected against vaccine-preventable diseases is examined in this overview.

INTRODUCTION

These difficult hard times will pass. This optimism is predicated in large part on the development and availability of an effective COVID-19 vaccine. India is poised to play a key role in the development of a vaccine and the recovery of the world’s corona victims. A vaccination programme covering a population of 1.3 billion people is likely to be a daunting endeavour, although India has successfully undertaken countrywide immunisation campaigns in the past. Soon after the possibility of COVID-19 spreading in India was apparent, the Indian government was observed to take some swift preventive actions, including an unprecedented nationwide lockdown.[1] In the meantime, it took a number of affirmative regulatory moves and initiatives to make the vaccine development process go more smoothly.

The second wave of the COVID-19 pandemic was a wrecking devastation in India, wreaking damage disproportionately on our poorer citizens.[2] The impoverished were left to fend for themselves as a result of the sporadic lockdowns and the resulting economic consequences. With the massive numbers we’re seen during the second wave, even having the financial means to pay for private treatment was becoming increasingly irrelevant. The pandemic’s rapidly escalating death toll crushed the entire system.[3] This devastating surge of illness and death may be averted if practically the whole adult population was vaccinated quickly and widely.

VACCINATION IN INDIA

In India, the world’s largest vaccination programme began, with free COVID vaccine being distributed across the country only to “prioritised beneficiaries,” which include three million healthcare and frontline workers.[4] The Press Information Bureau (PIB) released the specifics of India’s COVID-19 Vaccination Strategy [5]on April 19, 2021, with a focus on the scale and speed for the third phase. The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), chaired by Dr V K Paul, Member of the NITI Aayog, had played a vital role in creating the plan. On January 16, the first phase of India’s COVID-19 mass immunisation programme began, with an estimated 30 million healthcare and front-line workers being vaccinated. The country began the second phase on March 1st, with the goal of covering adults over 45 years with co-morbidities and those over 60 of age. This was expanded on 1 April to cover everyone above 45 years, bringing the total to over 300 million people. While this number constituted for only 22 percent of the population, they were also the high-risk and most vulnerable, accounting for 80 percent of recorded Covid death in the country.[6] The projected timescale for completing the immunisation programme was six months from the commencement.

As of April 18, 123.8 million doses had been provided out of a target of 600 million by the end of July.[7] However, it was also in April that the country was hit by a big second wave of refugees. India registered 96,000 new cases of infection each day at the peak of the first wave in mid-September 2020; by 18 April, the daily numbers had surpassed 275,000, hitting an all-time high of almost 400,000 cases in early May. Daily deaths also charted a strong slope, temporarily crossing 4,500, and have remained high ever since.

The rapid increase in cases and deaths prompted the Indian government to launch the third phase of its immunisation campaign in April, which would include individuals above the age of 18 beginning on May 1st, bringing the total number of persons vaccinated to 600 million. While vaccines for individuals over 45 will continue to be free, immunizations for people between the ages of 18 and 45 may be either free or expensive, depending on the state governments’ decisions. From 1 May, the two licensed vaccine producers—Serum Institute of India (SII), which produces Covishield, and Bharat Biotech (BB), which produces Covaxin—would furnish the central government with half of their monthly production.[8] The remaining funds will go to state governments and private hospitals. Both components of the decision—opening up to the 18-45 demographic, and dual pricing—were defended as promoting decentralisation and flexibility.

RIGHT TO FREE VACCINE

In this regard, there is growing controversy about whether the right to such life-saving immunizations should be included in basic human rights. When we consider the matter from a political standpoint, it is clear that a modern Welfare State must assure the protection of fundamental human rights. It should offer social services to its residents, especially public health services. These services must be available to all citizens, regardless of their financial situation. As a result, the government’s political efforts should include, among other things, promoting social programmes for disease prevention and cure.

International jurisprudence also appears to favour a human rights-based approach. Every person has the right to a level of living that is necessary for their health and well-being, according to the Universal Declaration of Human Rights (1948), Art. 25.[9] This encompasses a slew of rights, including access to medical treatment and financial stability in the event of unemployment, disease, or other loss of income due to events beyond one’s control. Similarly, Article 12 of the International Covenant of Economic, Social, and Cultural Rights (1966)[10] establishes a right to health and requires member governments to take measures to prevent, control, and treat epidemic diseases.

Although the right to health is not specifically recognised as a basic right in India’s Constitution, the country’s highest court has often emphasised its importance. In instances like Bandhua Mukti Morcha v Union of India & Ors,[11] Consumer Education and Research Centre v. Union of India,[12] and Paschim Banga Khet Mazdoor Samity & Ors. V. State of West Bengal[13], the Supreme Court has set precedent. Article 21 of the Constitution was construed by the Supreme Court to include a right to health. There is a case can be made for offering free vaccines even from an economic one. A healthy population is necessary for a healthy economy to thrive. Perhaps this is why even countries that support free market economy, such as Switzerland, provide free COVID-19 vaccines to its citizens.

The counterargument is that India lacks the financial and economic resources to carry out such a large-scale welfare programme. This argument lacks validity, given that we as a nation have squandered significant sums on a number of vanity projects in the recent past. The terrible track record of India’s healthcare spending is well known. Our country’s public health spending has been stable at little over 1% of GDP for the past decade, making it one of the lowest in the world.[14] According to the National Health Policy of 2015, healthcare costs put more than 63 million people in poverty each year.[15] Free vaccines for all residents would, without a doubt, be a bare minimum that the government should provide to make apologies for past failures.

In addition to the illnesses that many have suffered, the economic slowdown in India as a result of the pandemic has left thousands of individuals without a source of income. If the government wants to rehabilitate the general public and assist them in getting back on their feet, the first step would be to ensure that all residents receive free vaccination.

WHAT MAY BE THE FUTURE COURSE OF ACTION BY THE GOVERNMENT?

In the face of a vaccine deficit in the country, NEGVAC declared that between August and December 2021, it expects to produce around 2.16 billion COVID-19 vaccine doses[16], all from domestic production, plus Sputnik production and additional vaccines in development. It’s a lofty ambition, and NEGVAC’s track record suggests it has a proclivity for exaggerating capabilities. It’s feasible that the anticipated import of 250 million Sputnik V dosages may offset any overestimation to some extent.[17] It’s also worth noting that publicly available production numbers can be deceiving because data for vaccines still in development (about 710 million doses) have been included. Despite the fact that several of these vaccinations are in Phase III studies, many have only recently begun Phase I and Phase II testing. Phase III trials are underway for the Biological E and Zydus Cadilla vaccines, while Phase I-II trials are underway for BB’s nasal vaccine and Gennova’s mRNA-based vaccination. SII is now producing Covovax, the Indian form of the Novavax vaccine, at its own risk until approvals are obtained, and studies are proceeding in India. SII and BB have monthly production rates of 150 million and 110 million, respectively, which differ from what the firms have declared to the government. This isn’t to say that SII and BB can’t increase productivity; it just means that good planning and resource allocation are required. After three months, the expansion approved in April will come to fruition, along with a working production line.

No government money were supplied to SII and BB for vaccine research, according to the Centre’s affidavit to the Supreme Court[18]; rather, the Indian Council of Medical Research (ICMR) provided INR 350 million to BB for Phase III studies and INR 110 million to SII for bridging trials.[19] Pfizer, while being the first vaccine company to submit for clearance in India, ultimately withdrew its application due to procedural issues; at the same time, the Sputnik V approval application was delayed for weeks before being fast-tracked during the second wave’s initial onslaught. Despite the fact that the approval process was not as quick as it should have been in an emergency, it is unclear whether approving vaccines manufactured by Pfizer or Moderna would have changed the reality in India, given global shortages that have even the wealthiest countries in line despite their purchasing power.

According to a recent review of company filings by the top four global vaccine producers, 90 percent of all vaccines produced in the United States (US) and Europe in the first quarter of 2021 were administered to populations in North America and Europe. The scenario will remain unchanged in the second quarter. This highlights the necessity of developing and growing vaccine production capacity in the developing countries, and may explain why India chose to focus on leveraging its own manufacturing capacity rather than risking too much money on a market with too few doses.[20] Unfortunately, India failed to prioritise local vaccine development and production in a timely manner, and the goal of 2.16 billion doses between August and December now appears to be far-fetched.

There are currently no advanced procurement negotiations scheduled beyond July. The European Commission’s vaccine deployment strategy [21]is based on two key pillars: ensuring sufficient vaccine production for all EU member states through advance purchase agreements, and adapting the regulatory framework for vaccine development and availability to meet the urgent requirements of the pandemic. The European Union (EU) had obtained more than 2.3 billion vaccine doses by January 2021,[22] enough to cover the whole population of the region. It demonstrated the advantages of signing long-term advance procurement contracts before the vaccinations were officially approved. Although India briefly held the record for administering four million vaccines in a single day- in the first week of April, before China quickly overtook it – this will be of little benefit if it fails to solve the issue.

To be honest, given India’s population, vaccine demand is neither surprising nor surprising. Even the initial distribution plan set a goal of 600 million doses to 300 million persons over 45 years old in six months. However, the central government’s current purchase budget is barely $356 million. While it is projected that the states and private institutions will have access to up to 120-160 million doses based on production levels, a major portion of this will be used for the 18-45 age range.

Because of the magnitude of the second wave that hit India, the country’s lack of planning became a topic of global debate. Although the first hints of this wave appeared in early March, the country was unprepared at the time since it could not forecast how quickly it would spread. The mere chance of a second wave was not taken seriously enough, and all areas of the pandemic response, including vaccination, suffered as a result. Only an early lockdown may have helped India lessen the lethal impact of the second wave—a solution that India couldn’t afford at the time, despite the fact that most states quickly went into lockdown after the infection spread widely. In retrospect, the policy focus moved from saving lives in the immediate term to controlling infection and disease in the medium term by opting for a moderate rollout to a larger population rather than fast vaccination of specific groups. Delaying vaccination for everyone in the 18-44 age group and instead prioritising high-risk groups within the group when sufficient doses could not be obtained may have saved many lives in the current wave, at least in the second half.

VACCINE HESITANCY

The major immunisation campaign against COVID-19 began in India. As a result of the various concerns and fears surrounding the vaccine, many people are delaying vaccination, the entire vaccination process, as well as dispelling unfounded rumours and anxieties.

In the last month, India has seen a record number of COVID-19 infections, with over 26 million infections and 291,873 deaths. While many people believe that India’s deaths are undercounted, the number of diseases and deaths continues to climb. After wreaking havoc on India’s metropolis, COVID-19 is now sweeping the country’s rural, which have far less developed health facilities than their urban counterparts. Rural India is home to 895 million people, or 66 percent of the country’s population. Urban areas, on the other hand, are home to roughly 60% of hospitals, 80% of doctors, and 75% of medical facilities.

According to a study published on May 7, nearly half of India’s illnesses (48.5%) are now being reported from the country’s rural areas. The paper stressed the importance of vaccination as a primary method for reducing infection severity. “We must vaccinate our people on a mission mode, even if it means temporarily pausing economic activity once the second wave subsides,” the report stated, highlighting the country’s sluggish rate of immunisation.

Vaccines save millions of lives each year, according to the World Health Organization, and inoculation against COVID-19 will put an end to the pandemic. However, vaccination penetration in rural India is limited by a number of issues, one of which is vaccine apprehension, which has been fuelled by rumours that vaccines include pig flesh, cow blood, and can cause infertility or even death.

PUBLIC OPINION IN INDIA ABOUT THE COVID-19 VACCINE- CHANGE OVER DRURING THE COVID-19 CRISIS

Although the majority of people’s attitudes on social media about vaccines and their effects are neutral, just 35% are positive, which should be a source of concern for the government and policymakers. Vaccination will not be successful unless and until the government can persuade the majority of the populace that the vaccine’s results and effects will be favourable. With just over 35% of people positive about vaccines, the Indian government should concentrate on eliminating vaccine phobia before conducting mass immunisation.

MAJOR CONCERN OF INDIAN CITIZENS TOWARDS COVID-19 VACCINE

Despite the fact that COVID-19 has infected approximately 11 million people in India, many Indian citizens believe the pandemic is overblown. Citizens will reject the vaccine as a result of this mindset. Apart from that, scepticism about the vaccine’s nationality, scepticism about vaccine trials, scepticism about health after taking the vaccine, fear of death from the vaccine,[23] allergic reactions to the vaccine, distrust of pharmaceutical companies, doubts about data provided by vaccine companies, the prevalence of numerous vaccines and concerns about choosing the safest, and scepticism about the vaccine’s nationality.

While the Indian public has legitimate worries about the COVID-19 vaccine, several superstitious unfounded conspiracy theories, such as COVID-19 being overstated and a disdain or disbelieve for specific vaccines based on nationality, have also been expressed when addressing the COVID-19 vaccine. According to our research, a sizable portion of the Indian people on social media does not trust the government or pharmaceutical corporations.[24]

With new research indicating that even COVID-19 survivors’ immunity is only likely to last for eight months[25], politicians and the government must spend in educating the general population about the benefits of vaccination and the importance of returning to normal life. Governments, pharmaceutical corporations, and non-governmental organisations should make significant efforts to educate the general population about the immunisation programme and the importance of implementing it in order to return to normal life. Special attention should be paid to addressing all of the public’s fears and misconceptions about the COVID-19 vaccines, in order to motivate and bring enthusiasm in them.

COMPULSORY VACCINATION

A recent refusal by a well known tennis player Novak Djokovic’s to undergo mandatory Covid-19 vaccine[26] before playing tennis or travelling has boosted global anti-vaxxer movements[27]. So a question arises that although such organisations do not exist in India, does the legal structure allow the government to compel forced/mandatory vaccination?

RANGE OF OPTIONS BY THE GOVERNMENT

Any move toward mandatory vaccination must be based on broader public interest. While a person may assume she is immune to the disease and so does not require vaccination, this does not prevent her from infecting others who are in the high-risk category. As a result, vaccination against infectious illnesses is more than just a personal choice; it can also be viewed as a requirement for the sake of public health. Parliament and state legislatures can always establish a particular law containing such an obligation as a legislative measure. The Compulsory Vaccination Act of 1892[28], enacted by the British government in response to the smallpox pandemic, did something similar.

If governments desire to take executive action, there are a number of laws in place that allow them to do so. The Epidemic Diseases Act of 1897[29] gives state governments the authority to take whatever steps are required to prevent an epidemic disease from erupting or spreading. While the state government must be satisfied that existing laws are insufficient to cope with the epidemic before exercising this power, it would not be excessive for them to take such a step to deal with the century’s largest health disaster.

The National Disaster Management Act of 2005[30] gives the national authority and the national executive committee established by the Act extensive powers. The range of powers (sections 6 and 10) allows these authorities to compel mandatory vaccination through relevant state and federal government ministries. Section 62 of the Act also allows the central government to enact such a measure.[31]

Another option for governments to enforce mandatory vaccination is to put substantial expenses on those who refuse to get vaccinated without making it criminal. For example, under the Passport Act of 1967[32], the government can refuse to grant a passport to anyone who refuses to get vaccinated or withdraw a passport that has already been issued. In the case of Covid-19 vaccination, the government can justify its decision by citing the need to maintain friendly relations with neighbouring countries or the broader public’s benefit. In the absence of immunisation, the government can impose restrictions on public work or create disqualifications for receiving welfare benefits.

Anyone intending to enter India may be required to be vaccinated by the central government. Residents of polio-infected countries such as Pakistan, Afghanistan, Nigeria, and others, for example, are not permitted to enter India unless they have been vaccinated. Such criteria are also in place in the United States in regard to a variety of ailments. Nothing, then, can prevent the government from requiring Covid-19 vaccination for everyone intending to enter India.

EQUAL ACCESS TO VACCINE

While there have been no organised anti-vaxxer groups in India in the recent decade, there have been worries about vaccination hesitancy, which has resulted in the re-emergence of previously eradicated illnesses such as diphtheria.[33] In other places of India, polio vaccination was also met with significant resistance. In India, much of the public’s apprehension about vaccines appears to stem from mistrust of public health organisations and a lack of understanding of vaccination research.

If the government makes the Covid 19 vaccine mandatory in India, two legal grounds can be invoked: the right to privacy and the right to religious freedom.[34] It is important to remember that the freedom to profess religion is subject to any restrictions imposed on the basis of public order, morality, or health. In the case of K.S Puttaswamy v Union of India,[35] the Supreme Court made it plain that the right to privacy is not an absolute right that can be reduced if the method is fair, just, and reasonable, and the proportional limits serve a valid governmental goal.

However, for such a measure to be constitutional, the state would need to make free and accessible immunisation available to the marginalised people. Equal access to vaccination is vital, and any mechanism put in place should not be hampered by economic disparities or social marginalisation.

CONCLUSION

The COVID-19 pandemic has wreaked havoc on people’s lives and livelihoods all over the world. Vaccine development provides a ray of hope for a resolution to this dilemma. Vaccine apprehension poses a severe threat to global health because additional time allows the virus to evolve. It’s possible that the vaccines won’t be effective against all virus alterations in the future. As a result, it becomes vital to break through the barrier of vaccine apprehension. Vaccine acceptance rates vary by country and are influenced by socio-demographic, community, and psychological variables. The main issues that hinder people from taking vaccine are related to short- or long-term side effects, vaccine safety, and vaccine necessity. Vaccination is not essential for specific age groups, for example, is a harmful belief. If more rigorous studies confirm that vaccines are safe and effective, higher acceptance rates can be reached. Additionally, targeted public awareness campaigns can aid in the resolution of vaccine-related concerns. The sooner the world accepts the COVID-19 vaccination, sooner things will get better.


[1] Editorial, “P M Modi announces 21-day lockdown as COVID- 19 toll touches 12”, The Hindu”, March 25, 2020.

[2] Sujita Kumar Kar, Ramadas Ransing, S.M. Yasir Arafat, Vikas Menon, “Second wave of COVID- 19 pandemic in India: Barriers to effective governmental response” , E Clinical Medicine- THE LANCET, May 29, 2021.

[3]Soutik Biswas, “Covid 19: Has India’s deadly second wave peaked?” , BBC News, 26th May 2021 

[4] Editor, “ India’s Covid vaccination drive: Over 1.9 lakh frontline workers get first jabs on day 1”, The Indian Express, Jan 16, 2021

[5] Press Information Bureau, “Government of India announces a liberalised and accelerated Phase 8 strategy of Covid- 19 vaccination from 1st May”, 19 April 2021 

[6] Press Information Bureau, “Press briefing on the action taken, preparedness and updates on COVID- 19”, 13 May 2021.

[7] Ministry of Health and Family Welfare, Government of India, Covid 19 vaccine operational guidelines, 28 Dec 2020.

[8] Payal Banerjee, “Central government asks serum, Bharat Biotech to cut vaccine prices” The Indian Express, 27 April 2021. 

[9] United Nations, Universal Declaration of Human Rights

[10] United nations Human Rights, International Covenant on Economics, Social and Cultural Rights

[11] Bandhua Mukti Morcha V. Union Of India & Ors. (1997) 10 SCC 549

[12] Consumer Education and Research Centre, V. Union of India, 1995 SCC (3) (India) 

[13] Paschim Banga Khet Mazdoor Samity V. State of West Bengal, 1996 SCC (4) 37, JT 1996 (6) 43

[14] Sadhika Tiwari, “India Spent 1% of GDP on Public Health for 15 years, result is vulnerability to crisis.” , India Spend, Jun 26, 2020

[15] Editor, “ 63 million people faced with poverty due to healthcare expenditure”, The Times Of India, 4th Jan, 2015

[16] Editor, “India readies state-run firms to manufacture Covaxin”, Live Mint, May 16, 2021

[17] Oommen C Kurian, “Next three months of the world’s largest vaccination drive: Managing expectations”, Observer Research Foundation, 4th May 2021.   

[18] Editor, “No financial aid given to SII & Bharat Biotech: Govt in SC”, The Times of India, May 11, 2021

[19] “AFFIDAVIT DATED 09:05:2021, ON BEHALF OF THE UNION OF INDIA”, Live Law

[20] Sridharan, Anand, “Makers Keepers: What can we learn from listed vaccine makers”, 9th May 2021

[21] European Commission, Corona virus: Commission unveils EU vaccines strategy, 17th June 2020

[22] European Commission, Questions and Answers on vaccine negotiations, Jan 8th 2021

[23] Ritu Sharma, “In this village, residents fear ‘death on vaccination’”, The Indian Express, June 22, 2021

[24] Editor, “Misinformation and fear about COVID vaccine”, The New Indian Express , 20th Jan 2021

[25] Editor, “Recovered COVID – 19 patients immunity for 8 months, raise hope for vaccine”, India Today, 2020

[26] Unnati Sharma, “Novak Djokovic’s says he doesn’t want to be ‘forced’ by someone to take COVID-19 vaccine”, The Print, 21st April 2020

[27] Liz Szabo, “The anti- vaccine and anti- lockdown movements are converging, refusing to be ‘enslaved’”, Los Angeles Times, April 24, 2020

[28] Chandrakant Lahariya, “A brief history of vaccines and vaccination in India”, Indian Journal of Medical Research(IJMR), April 2014.

[29] The Epidemic Diseases Act, 1897, https://www.indiacode.nic.in/bitstream/123456789/15942/1/epidemic_diseases_act%2C1897.pdf

[30] National Disaster Management Act, 2005, https://cdn.s3waas.gov.in/s365658fde58ab3c2b6e5132a39fae7cb9/uploads/2018/04/2018041720.pdf

[31] National Disaster Management Act, 2005, Sec. 62

[32] Passport Act, 1967, https://portal1.passportindia.gov.in/AppOnlineProject/pdf/passports_act.pdf

[33] Madhurima Shukla, “Growing fear about vaccination(including India) is bringing back eradicated diseases”, Scroll, Mar 30, 2019

[34] Julia Belluz, “Religion and vaccine refusal are linked. We have to talk about it”, Vox, June 19, 2019 

[35] K.S. Puttaswamy v. Union of India, (2017) 10 SCC 1

Author: Ashwarya Sharma, Narsee Monjee Institute of Management and Studies (School Of Law), Indore

Editor: Kanishka VaishSenior Editor, LexLife India.

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