# JACOB PULIYEL v. UNION OF INDIA & ORS

- **Citation:** [2022] 3 S.C.R. 471
- **Court:** Supreme Court of India
- **Decided:** 2022-05-02
- **Bench:** L. Nageswara Rao, B. R. Gavai
- **Source:** https://unisonlegal.in/judgment/supreme-court-of-india/jacob-puliyel-v-union-of-india-ors-35945
- **Pages:** 77

## Headnote

Public health - COVID-19 pandemic - Vaccines and other
public health measures - Fundamental rights of individuals - Bodily
integrity and personal autonomy of an individual - Held: Bodily
integrity is protected under Art. 21 of the Constitution and no
individual can be forced to be vaccinated - Further, personal
autonomy of an individual, which is a recognised facet of the
protections guaranteed under Art. 21, encompasses the right to
refuse to undergo any medical treatment in the sphere of individual
health - However, in the interest of protection of communitarian
health, the Government is entitled to regulate issues of public health
concern by imposing certain limitations on individual rights, which
are open to scrutiny by constitutional courts to assess whether such
invasion into an individual's right to personal autonomy and right
to access means of livelihood meets the threefold requirement as
laid down in K.S. Puttaswamy case, i.e., (i) legality, which
presupposes the existence of law; (ii) need, defined in terms of a
legitimate State aim; and (iii) proportionality, which ensures a
rational nexus between the objects and the means adopted to achieve
them - Constitution of India, 1950 - Art. 21.
Public health - COVID-19 pandemic - Vaccines and other
public health measures - Vaccination policy - Restrictions on
unvaccinated individuals -Challenge to - Held: Substantial material
filed before the Court reflecting the near-unanimous views of experts
on benefits of vaccination in addressing severe disease from the
infection, reduction in oxygen requirement, hospital and ICU
admissions, mortality and stopping new variants from emerging -
Current vaccination policy of the Union of India is informed by
relevant considerations and cannot be said to be unreasonable or
manifestly arbitrary - However, no data placed by Union of India
or the States, controverting the material placed by the Petitioner in
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the form of emerging scientific opinion which appears to indicate
that the risk of transmission of the virus from unvaccinated
individuals is almost on par with that from vaccinated persons - In
light of this, restrictions on unvaccinated individuals imposed
through various vaccine mandates by State Governments / Union
Territories cannot be said to be proportionate - Till the infection
rate remains low and any new development or research finding
emerges which provides due justification to impose reasonable and
proportionate restrictions on the rights of unvaccinated individuals,
it is suggested that all authorities in this country, including private
organisations and educational institutions, review the relevant orders
and instructions imposing restrictions on unvaccinated individuals
in terms of access to public places, services and resources, if not
already recalled - It is however clarified that in the context of the
rapidly-evolving situation presented by the COVID-19 pandemic,
the suggestion to review the vaccine mandates imposed by States /
Union Territories, is limited to the present situation alone and is not
to be construed as interfering with the lawful exercise of power by
the executive to take suitable measures for prevention of infection
and transmission of the virus - The suggestion also does not extend
to any other directions requiring maintenance of COVID-appropriate
behaviour issued by the Union or the State Governments.
Public health - COVID-19 pandemic - Clinical trials of
vaccines - Non-disclosure of segregated clinical data - Held: The
results of Phase III clinical trials of the vaccines in question have
been published, in line with the requirement under the statutory
regime in place, Good Clinical Practices (GCP) guidelines and the
WHO Statement on Clinical Trials - Material provided by Union of
India, comprising of minutes of the meetings of the SEC, do not
warrant the conclusion that restricted emergency use approvals had
been granted to COVISHIELD and COV

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 [2022] 3 S.C.R. 471
471
JACOB PULIYEL
v.
UNION OF INDIA & ORS.
(Writ Petition (Civil) No. 607 of 2021)
MAY 02, 2022
[L. NAGESWARA RAO AND B. R. GAVAI, JJ.]
Public health - COVID-19 pandemic - Vaccines and other
public health measures - Fundamental rights of individuals - Bodily
integrity and personal autonomy of an individual - Held: Bodily
integrity is protected under Art. 21 of the Constitution and no
individual can be forced to be vaccinated - Further, personal
autonomy of an individual, which is a recognised facet of the
protections guaranteed under Art. 21, encompasses the right to
refuse to undergo any medical treatment in the sphere of individual
health - However, in the interest of protection of communitarian
health, the Government is entitled to regulate issues of public health
concern by imposing certain limitations on individual rights, which
are open to scrutiny by constitutional courts to assess whether such
invasion into an individual's right to personal autonomy and right
to access means of livelihood meets the threefold requirement as
laid down in K.S. Puttaswamy case, i.e., (i) legality, which
presupposes the existence of law; (ii) need, defined in terms of a
legitimate State aim; and (iii) proportionality, which ensures a
rational nexus between the objects and the means adopted to achieve
them - Constitution of India, 1950 - Art. 21.
Public health - COVID-19 pandemic - Vaccines and other
public health measures - Vaccination policy - Restrictions on
unvaccinated individuals -Challenge to - Held: Substantial material
filed before the Court reflecting the near-unanimous views of experts
on benefits of vaccination in addressing severe disease from the
infection, reduction in oxygen requirement, hospital and ICU
admissions, mortality and stopping new variants from emerging -
Current vaccination policy of the Union of India is informed by
relevant considerations and cannot be said to be unreasonable or
manifestly arbitrary - However, no data placed by Union of India
or the States, controverting the material placed by the Petitioner in
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the form of emerging scientific opinion which appears to indicate
that the risk of transmission of the virus from unvaccinated
individuals is almost on par with that from vaccinated persons - In
light of this, restrictions on unvaccinated individuals imposed
through various vaccine mandates by State Governments / Union
Territories cannot be said to be proportionate - Till the infection
rate remains low and any new development or research finding
emerges which provides due justification to impose reasonable and
proportionate restrictions on the rights of unvaccinated individuals,
it is suggested that all authorities in this country, including private
organisations and educational institutions, review the relevant orders
and instructions imposing restrictions on unvaccinated individuals
in terms of access to public places, services and resources, if not
already recalled - It is however clarified that in the context of the
rapidly-evolving situation presented by the COVID-19 pandemic,
the suggestion to review the vaccine mandates imposed by States /
Union Territories, is limited to the present situation alone and is not
to be construed as interfering with the lawful exercise of power by
the executive to take suitable measures for prevention of infection
and transmission of the virus - The suggestion also does not extend
to any other directions requiring maintenance of COVID-appropriate
behaviour issued by the Union or the State Governments.
Public health - COVID-19 pandemic - Clinical trials of
vaccines - Non-disclosure of segregated clinical data - Held: The
results of Phase III clinical trials of the vaccines in question have
been published, in line with the requirement under the statutory
regime in place, Good Clinical Practices (GCP) guidelines and the
WHO Statement on Clinical Trials - Material provided by Union of
India, comprising of minutes of the meetings of the SEC, do not
warrant the conclusion that restricted emergency use approvals had
been granted to COVISHIELD and COVAXIN in haste, without
thorough review of the relevant data - Relevant information relating
to meetings of Subject Expert Committee (SEC) [the body which
sends recommendations to the Central Drugs Standard Control
Organisation] and National Technical Advisory Group on
Immunization (NTAGI) are available in public domain and therefore,
challenge to the procedures adopted by the expert bodies while
granting regulatory approval to the vaccines on the ground of lack
of transparency cannot be entertained - However, subject to the
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protection of privacy of individual subjects, with respect to ongoing
clinical trials and trials that may be conducted subsequently for
COVID-19 vaccines, all relevant data required to be published under
the extant statutory regime must be made available to the public
without undue delay.
Public health - Immunisation - Adverse Events Following
Immunisation (AEFI) - Central Drugs Standard Control
Organisation (CDSCO) - Sweeping challenge to the monitoring
system of AEFIs being faulty and not reflecting accurate figures of
those with severe reactions or deaths from vaccines, not acceptable
- Role of the Pharmacovigilance Programme of India - CDSCO, as
elaborated upon by Union of India, collates and studies previously
unknown reactions seen during monitoring of AEFIs at the time of
vaccine administration - Union of India to ensure that this leg of
the AEFI surveillance system is not compromised with, while meeting
the requirements of the rapid review and assessment system followed
at the national level for AEFIs.
Public health - Immunisation - Adverse effects following
immunisation - Information relating to - Held: Such information is
crucial for creating awareness around vaccines and their efficacy,
apart from being instrumental in further scientific studies around
the pandemic - Imperative need for collection of requisite data of
adverse events and wider participation in terms of reporting - Union
of India directed to facilitate reporting of suspected adverse events
by individuals and private doctors on an accessible virtual platform
- These reports shall be made publicly accessible, without
compromising on protecting the confidentiality of the persons
reporting, with all necessary steps to create awareness of the
existence of such a platform and of the information required to
navigate the platform to be undertaken by the Union of India at the
earliest.
Public health - Vaccination - Paediatric vaccination - Policy
decision - Scope of review - Held: Decision taken by Union of
India to vaccinate children in the country is in tune with global
scientific consensus and expert bodies like the WHO, the UNICEF
and the CDC - It is beyond the scope of review for the Court to
second-guess expert opinion, on the basis of which the Government
has drawn up its policy - Keeping in line with the WHO Statement
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on Clinical Trials and the extant statutory regime, Union of India
directed to ensure that key findings and results of the relevant phases
of clinical trials of vaccines already approved by the regulatory
authorities for administration to children, be made public at the
earliest, if not already done.
Public Health - Policy decisions based on expert opinion -
Judicial review - Scope - Held: Court would be slow in interfering
with matters of policy, especially those connected to public health -
Wide latitude is provided to the executive in matters involving policy
decisions based on expert opinion - Court does not have the
expertise to appreciate and decide on merits of scientific issues on
the basis of divergent medical opinion - However, this does not bar
the Court from scrutinising whether the policy in question can be
held to be beyond the pale of unreasonableness and manifest
arbitrariness and to be in furtherance of the right to life of all
persons, bearing in mind the material on record - Constitution of
India, 1950 - Art. 14.
Evidence - News item published in newspaper - Admissibility
- Held: The courts cannot take judicial notice of facts stated in a
news item published in a newspaper - A statement of fact contained
in a newspaper is merely hearsay and therefore, inadmissible in
evidence, unless proved by the maker of the statement appearing in
court and deposing to have perceived the fact reported - Judicial
Notice.
Public interest litigation - Public interest litigation moved by
a person having knowledge in the subject-matter of the lis and,
thus, having an interest therein, as contradistinguished from a
busybody, in the welfare of people - Maintainability of.
Disposing the writ petition, the Court
HELD: Judicial review of public policies relating to health
- Ambit of
1.1. The Courts, in exercise of their power of judicial review,
do not ordinarily interfere with the policy decisions of the
executive unless the policy can be faulted on grounds of mala
fide, unreasonableness, arbitrariness or unfairness etc. Indeed,
arbitrariness, irrationality, perversity and mala fide will render
the policy unconstitutional. It is neither within the domain of the
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courts nor the scope of judicial review to embark upon an enquiry
as to whether a particular public policy is wise or whether better
public policy can be evolved. Nor are the courts inclined to strike
down a policy at the behest of a petitioner merely because it has
been urged that a different policy would have been fairer or wiser
or more scientific or more logical. Courts do not and cannot act
as appellate authorities examining the correctness, suitability and
appropriateness of a policy, nor are courts advisors to the
executive on matters of policy which the executive is entitled to
formulate. The scope of judicial review when examining a policy
of the Government is to check whether it violates the fundamental
rights of the citizens or is opposed to the provisions of the
Constitution, or opposed to any statutory provision or manifestly
arbitrary. [Para 21][497-B-E]
1.2. The courts should not rush in where even scientists
and medical experts are careful to tread. The rule of prudence is
that courts will be reluctant to interfere with policy decisions
taken by the Government, in matters of public health, after
collecting and analysing inputs from surveys and research. Nor
will courts attempt to substitute their own views as to what is
wise, safe, prudent or proper, in relation to technical issues
relating to public health in preference to those formulated by
persons said to possess technical expertise and rich experience.
Where expertise of a complex nature is expected of the State in
framing rules, the exercise of that power not demonstrated as
arbitrary must be presumed to be valid as a reasonable restriction
on the fundamental right of the citizen and judicial review must
halt at the frontiers. The Court cannot re-weigh and substitute
its notion of expedient solution. Within the wide judge-proof areas
of policy and judgment open to the government, if they make
mistakes, correction is not in court but elsewhere. That is the
comity of constitutional jurisdictions in our jurisprudence. One
cannot evolve a judicial policy on medical issues. All judicial
thought, Indian and Anglo-American, on the judicial review power
where rules under challenge relate to a specialised field and
involve sensitive facets of public welfare, has warned courts of
easy assumption of unreasonableness of subordinate legislation
on the strength of half- baked studies of judicial generalists aided
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by the ad-hoc learning of counsel. However, the Court certainly
is the constitutional invigilator and must act to defend the citizen
in the assertion of his fundamental rights against executive
tyranny draped in disciplinary power. [Para 22][497-E-G;
498-A-D]
1.3. The Court would be slow in interfering with matters of
policy, especially those connected to public health. There is also
no doubt that wide latitude is given to executive opinion which is
based on expert advice. However, it does not mean that this Court
will not look into cases where violation of fundamental rights is
involved and the decision of the executive is manifestly arbitrary
or unreasonable. It is true that this Court lacks the expertise to
arrive at conclusions from divergent opinions of scientific issues
but that does not prevent this Court from examining the issues
raised in this Writ Petition, especially those that concern violation
of Article 21 of the Constitution of India. [Para 25][499-E-F]
Vaccine mandates - If violative of Art.21 of the Constitution
2.1. Bodily integrity is protected under Article 21 of the
Constitution of India and no individual can be forced to be
vaccinated. Personal autonomy of an individual involves the right
of an individual to determine how they should live their own life,
which consequently encompasses the right to refuse to undergo
any medical treatment in the sphere of individual health. Persons
who are keen to not be vaccinated on account of personal beliefs
or preferences, can avoid vaccination, without anyone physically
compelling them to be vaccinated. However, if there is a likelihood
of such individuals spreading the infection to other people or
contributing to mutation of the virus or burdening of the public
health infrastructure, thereby affecting communitarian health at
large, protection of which is undoubtedly a legitimate State aim
of paramount significance in this collective battle against the
pandemic, the Government can regulate such public health
concerns by imposing certain limitations on individual rights that
are reasonable and proportionate to the object sought to be
fulfilled. [Para 49][516-B-F]
2.2. The Union of India is justified in centering its
vaccination policy around the health of the population at large,
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with emphasis on insulating the weaker and more vulnerable
sections from the risk of severe infection and its consequences,
as opposed to basing its decision keeping in mind the interests
of a healthy few. Given the considerable material filed before this
Court reflecting the near-unanimous views of experts on the
benefits of vaccination in dealing with severe disease, reduction
in oxygen requirement, hospital and ICU admissions and mortality
and stopping new variants from emerging, this Court is satisfied
that the current vaccination policy of the Union of India, formulated
in the interest of public health, is informed by relevant
considerations and cannot be said to be unreasonable. [Para 56]
[520-D-F]
2.3. While there is abundant data to show that getting
vaccinated continues to be the dominant expert advice even in
the face of new variants, no submission nor any data has been put
forth to justify restrictions only on unvaccinated individuals when
emerging scientific evidence appears to indicate that the risk of
transmission of the virus from unvaccinated individuals is almost
on par with that from vaccinated persons. To put it differently,
neither the Union of India nor the State Governments have
produced any material before this Court to justify the
discriminatory treatment of unvaccinated individuals in public
places by imposition of vaccine mandates. No doubt that when
COVID-19 vaccines came into the picture, they were expected
to address, and were indeed found to be successful in dealing
with, the risk of infection from the variants in circulation at the
time. However, with the virus mutating, one has seen more potent
variants surface which have broken through the vaccination
barrier to some extent. While vaccination mandates in the era of
prevalence of the variants prior to the Delta variant may have
withstood constitutional scrutiny, in light of the data presented
by the Petitioner, which has not been controverted by the Union
of India as well as the State Governments, the restrictions on
unvaccinated individuals imposed through vaccine mandates
cannot be considered to be proportionate, especially since both
vaccinated and unvaccinated individuals presently appear to be
susceptible to transmission of the virus at similar levels.
[Para 58][522-D-G; 523-A-B]
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2.4. Till the infection rate and spread remains low, as it is
currently, and any new development or research finding comes
to light which provides the Government due justification to impose
reasonable and proportionate restrictions on the rights of
unvaccinated individuals in furtherance of the continuing efforts
to combat this pandemic, it is suggested that all authorities in
this country, including private organisations and educational
institutions, review the relevant orders and instructions imposing
restrictions on unvaccinated individuals in terms of access to
public places, services and resources. [Para 59][523-D-F]
2.5. However, given the rapidly-changing nature of the virus
and the clear purpose served by the approved vaccines in terms
of restoration and protection of public health, the suggestions
with respect to review of vaccine mandates are limited to the
present situation alone. This judgment is not to be construed as
impeding, in any manner, the lawful exercise of power by the
executive to take suitable measures for prevention of infection
and transmission of the virus in public interest, which may also
take the form of restrictions on unvaccinated people in the future,
if the situation so warrants. Such restrictions will be subject to
constitutional scrutiny to examine if they meet the threefold
requirement for intrusion into rights of individuals. [Para 61]
[524-C-E]
Judicial notice of news item published in a newspaper
3. The courts cannot take judicial notice of facts stated in a
news item published in a newspaper. A statement of fact contained
in a newspaper is merely hearsay and therefore, inadmissible in
evidence, unless proved by the maker of the statement appearing
in court and deposing to have perceived the fact reported. In the
absence of anything on record in the present case to substantiate
the statement made by a member of the NTAGI, this Court is not
inclined to take judicial notice of the news article reported in
The Wire, even more so in light of the affidavit filed on behalf of
the Union of India stating that the relevant data was examined by
the expert bodies at all stages before granting emergency use
approval to the vaccines. Also, the evidence relating to the
approval process of the Rotavac vaccine has no relevance to the
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dispute in this case. On the basis of the said two incidents, it
cannot be concluded that the emergency use approval to
COVISHIELD and COVAXIN recommended by the SEC are not
in accordance with the statutory regime. [Para 70][530-G-H;
531-A-B]
Non-disclosure of segregated clinical trial data in public
domain
4. It is seen that there is a strict statutory regime in force
for grant of approvals to vaccines. Specialist bodies established
under the provisions of the Drugs and Cosmetics Act, 1940 and
the rules framed thereunder comprise of domain experts in the
relevant field, who conduct a thorough scrutiny of the material
produced by the manufacturers before granting approval. The
information provided on behalf of the Union of India substantiates
that the data provided by the vaccine manufacturers was
considered by the SEC over a period of time and several
conditions were imposed at the time of recommending approvals,
which have been modified or lifted subsequently on availability
of further data arising from the clinical trials before the SEC, as
can be seen from the minutes of the meetings of the SEC, available
on the website of the MoHFW. It cannot be said that emergency
approvals to the vaccines were given in haste, without properly
reviewing the data from clinical trials. Also, the Parliamentary
Standing Committee report relied upon by the Petitioner is not
relevant and the lapses pointed out therein pertain to the year
2011, which have no obvious connection to the grant of approval
to Respondent Nos. 4 and 5 for the restricted emergency use of
their respective vaccines. As long as the relevant information
relating to the minutes of the meetings of the regulatory bodies
and the key outcomes and findings of the trials are available in
public domain, the Petitioner cannot contend that every minute
detail relating to clinical trials be placed in public domain to enable
an individual to take an informed, conscious decision to be
vaccinated or not. Given the widespread affliction caused by the
virus, there was an imminent need of manufacturing vaccines
which would keep the infection at bay. Both the vaccines have
been approved by the WHO as well. A perusal of the material
placed on record would show that there is material compliance
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with the procedure prescribed under the Drugs and Cosmetics
Act, 1940 and the New Drugs and Clinical Trials Rules, 2019
framed under the said Act, before grant of approval for the
emergency use of the two vaccines. However, it is made clear
that subject to the protection of privacy of individual subjects
and to the extent permissible by the 2019 Rules, the relevant
data which is required to be published under the statutory regime
and the WHO Statement on Clinical Trials shall be made available
to the public without undue delay, with respect to the ongoing
post-marketing trials of COVAXIN and COVISHIELD as well as
ongoing clinical trials or trials that may be conducted subsequently
for approval of other COVID-19 vaccines / vaccine candidates.
[Para 76][535-E-H; 536-A-D]
Improper collection and reporting of Adverse Events
Following Immunisations (AEFIs).
5. There should be a mechanism by which individuals and
private doctors should be permitted to report suspected adverse
events. Information relating to adverse effects following
immunisation is crucial for the purpose of understanding the
safety of the vaccines that are being administered, apart from
being instrumental in further scientific studies around the
pandemic. There is an imminent need for collection of requisite
data of adverse events and wider participation of people in
reporting the adverse events is necessary for the purpose of
gathering correct information. Thus, the Union of India is directed
to facilitate the reporting of suspected adverse events by
individuals and private doctors on a virtual platform and the
reports so made shall be publicly accessible after being given
unique identification numbers, without listing any personal or
confidential data of the persons reporting. All necessary steps to
create awareness of, and to navigate, this platform for selfreporting shall be effectuated by the Government, roping in and
training relevant participants right from the ground level of
vaccine administration. [Para 84][541-F-H; 542-A]
Vaccination of children
6.1. This Court cannot sit in judgment of leading scientific
analysis relating to the safety of paediatric vaccination. Experts
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in science may themselves differ in their opinions while taking
decisions on matters related to safety and allied aspects, but that
does not entitle the Court to second-guess expert opinion, on
the basis of which the Government has drawn up its policies. The
decision taken by the Union of India to vaccinate paediatric
population in this country is in tune with global scientific
consensus and expert bodies like the WHO, the UNICEF and
the CDC have also advised paediatric vaccination. It would not
only be beyond jurisdiction of this Court but also hazardous if
this Court were to examine the accuracy of such expert opinion,
based on competing medical opinions. The scope of judicial review
does not entail the Court embarking upon such misadventures.
Therefore, the contention of the Petitioner, that this Court has
to intervene in paediatric vaccination on the ground that it is
unscientific, is rejected. [Para 87][543-C-F]
6.2. With respect to results of clinical trials, it is noted that
the Union of India has stated that the results of clinical trials of
COVAXIN for paediatric population have already been published.
It is further noted that for the age group of 12 to 14 years,
Biological E's Corbevax is being administered. Keeping in line
with the WHO Statement on Clinical Trials, the Declaration of
Helsinki and the GCP guidelines, the Union of India is directed
to ensure that key findings and results of the clinical trials of
Corbevax be published at the earliest, if not already done. Neither
vaccine is an mRNA vaccine and to this extent, the apprehensions
of the Petitioner with respect to the associated risks of mRNA
vaccines are unfounded in the present situation. [Para 88]
[543-F-H]
7. Conclusion
(i) Given the issues urged by the Petitioner have a bearing
on public health and concern the fundamental rights of individuals
in this country, this Court is not inclined to entertain any challenge
to the maintainability of the Writ Petition.
(ii) As far as judicial review of policy decisions based on
expert opinion is concerned, there is no doubt that wide latitude
is provided to the executive in such matters and the Court does
not have the expertise to appreciate and decide on merits of
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scientific issues on the basis of divergent medical opinion.
However, this does not bar the Court from scrutinising whether
the policy in question can be held to be beyond the pale of
unreasonableness and manifest arbitrariness and to be in
furtherance of the right to life of all persons, bearing in mind the
material on record.
(iii) With respect to the infringement of bodily integrity and
personal autonomy of an individual considered in the light of
vaccines and other public health measures introduced to deal
with the COVID-19 pandemic, this Court is of the opinion that
bodily integrity is protected under Article 21 of the Constitution
and no individual can be forced to be vaccinated. Further, personal
autonomy of an individual, which is a recognised facet of the
protections guaranteed under Article 21, encompasses the right
to refuse to undergo any medical treatment in the sphere of
individual health. However, in the interest of protection of
communitarian health, the Government is entitled to regulate
issues of public health concern by imposing certain limitations
on individual rights, which are open to scrutiny by constitutional
courts to assess whether such invasion into an individual's right
to personal autonomy and right to access means of livelihood
meets the threefold requirement as laid down in K.S. Puttaswamy
case, i.e., (i) legality, which presupposes the existence of law; (ii)
need, defined in terms of a legitimate State aim; and (iii)
proportionality, which ensures a rational nexus between the
objects and the means adopted to achieve them.
(iv) On the basis of substantial material filed before this
Court reflecting the near-unanimous views of experts on the
benefits of vaccination in addressing severe disease from the
infection, reduction in oxygen requirement, hospital and ICU
admissions, mortality and stopping new variants from emerging,
this Court is satisfied that the current vaccination policy of the
Union of India is informed by relevant considerations and cannot
be said to be unreasonable or manifestly arbitrary.
(v) However, no data has been placed by the Union of India
or the States, controverting the material placed by the Petitioner
in the form of emerging scientific opinion which appears to indicate
that the risk of transmission of the virus from unvaccinated
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individuals is almost on par with that from vaccinated persons. In
light of this, restrictions on unvaccinated individuals imposed
through various vaccine mandates by State Governments / Union
Territories cannot be said to be proportionate. Till the infection
rate remains low and any new development or research finding
emerges which provides due justification to impose reasonable
and proportionate restrictions on the rights of unvaccinated
individuals, it is suggested that all authorities in this country,
including private organisations and educational institutions,
review the relevant orders and instructions imposing restrictions
on unvaccinated individuals in terms of access to public places,
services and resources, if not already recalled. It is clarified that
in the context of the rapidly-evolving situation presented by the
COVID-19 pandemic, the suggestion to review the vaccine
mandates imposed by States / Union Territories, is limited to the
present situation alone and is not to be construed as interfering
with the lawful exercise of power by the executive to take suitable
measures for prevention of infection and transmission of the virus.
The suggestion also does not extend to any other directions
requiring maintenance of COVID-appropriate behaviour issued
by the Union or the State Governments.
(vi) As regards non-disclosure of segregated clinical data,
it is found that the results of Phase III clinical trials of the vaccines
in question have been published, in line with the requirement
under the statutory regime in place, the GCP guidelines and the
WHO Statement on Clinical Trials. The material provided by the
Union of India, comprising of minutes of the meetings of the SEC,
do not warrant the conclusion that restricted emergency use
approvals had been granted to COVISHIELD and COVAXIN in
haste, without thorough review of the relevant data. Relevant
information relating to the meetings of the SEC and the NTAGI
are available in public domain and therefore, challenge to the
procedures adopted by the expert bodies while granting
regulatory approval to the vaccines on the ground of lack of
transparency cannot be entertained. However, subject to the
protection of privacy of individual subjects, with respect to ongoing
clinical trials and trials that may be conducted subsequently for
COVID-19 vaccines, all relevant data required to be published
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under the extant statutory regime must be made available to the
public without undue delay.
(vii) One cannot accept the sweeping challenge to the
monitoring system of AEFIs being faulty and not reflecting
accurate figures of those with severe reactions or deaths from
vaccines. The role of the Pharmacovigilance Programme of India
and the CDSCO, as elaborated upon by the Union of India, collates
and studies previously unknown reactions seen during monitoring
of AEFIs at the time of vaccine administration and one trusts the
Union of India to ensure that this leg of the AEFI surveillance
system is not compromised with, while meeting the requirements
of the rapid review and assessment system followed at the national
level for AEFIs.
(viii) Information relating to adverse effects following
immunisation is crucial for creating awareness around vaccines
and their efficacy, apart from being instrumental in further
scientific studies around the pandemic. Recognising the
imperative need for collection of requisite data of adverse events
and wider participation in terms of reporting, the Union of India
is directed to facilitate reporting of suspected adverse events by
individuals and private doctors on an accessible virtual platform.
These reports shall be made publicly accessible, without
compromising on protecting the confidentiality of the persons
reporting, with all necessary steps to create awareness of the
existence of such a platform and of the information required to
navigate the platform to be undertaken by the Union of India at
the earliest.
(ix) On paediatric vaccination, this Court recognises that
the decision taken by the Union of India to vaccinate children in
this country is in tune with global scientific consensus and expert
bodies like the WHO, the UNICEF and the CDC and it is beyond
the scope of review for this Court to second-guess expert opinion,
on the basis of which the Government has drawn up its policy.
Keeping in line with the WHO Statement on Clinical Trials and
the extant statutory regime, the Union of India is directed to
ensure that key findings and results of the relevant phases of
clinical trials of vaccines already approved by the regulatory
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authorities for administration to children, be made public at the
earliest, if not already done. [Para 89 (ii) to (ix)][544-A-H; 545A-H; 546-A-H; 574-A-E]
Delhi Development Authority v. Joint Action Committee,
Allottee of SFS Flats (2008) 2 SCC 672 : [2007]
13 SCR 811; In re: Distribution of Essential Supplies
and Services During Pandemic, (2021) 7 SCC 772;
Ugar Sugar Works Ltd. v. Delhi Administration (2001)
3 SCC 635; Villianur Iyarkkai Padukappu Maiyam v.
Union of India (2009) 7SCC 561; Directorate of Film
Festivals v. Gaurav Ashwin Jain (2007) 4 SCC 737:
[2007] 5 SCR 7; Pyarali K.Tejani v. Mahadeo
Ramchandra Dange (1974) 1 SCC 167 : [1974]
2 SCR 154; Union of India v. Dinesh Engineering
Corporation (2001) 8 SCC 491; Common Cause (A
Registered Society) v. Union of India (2018) 5 SCC 1 :
[2018] 6 SCR 1; K. S. Puttaswamy v. Union of India
(2017) 10 SCC 1 : [2017] 10 SCR 569 and Ashwani
Kumar v. Union of India (2019) 2 SCC 636 : [2018]
13 SCR 1286 - relied on
Indian Banks' Association, Bombay v. Devkala
Consultancy Service (2004) 11 SCC 1 : [2004] 1 Suppl.
SCR 225; Academy of NutritionImprovement v. Union
of India, (2011) 8 SCC 274: [ 2011] 8 SCR 680; G.
Sundarrajan v. Union of India (2013) 6 SCC 620 :
[2013] 8 SCR 631; Shri Sitaram Sugar Company Ltd.
v. Union of India (1990) 3 SCC 223 : [1990] 1 SCR
909; Aruna Ramachandra Shanbaug v. Union of India
(2011) 4 SCC 454 : [2011] 4 SCR 1057; National
Legal Services Authority v. Union of India (2014) 5 SCC
438 : [2014] 5 SCR 119; X v. Hospital 'Z' (1998) 8
SCC 296 : [1998] 1 Suppl. SCR 723; Kharak Singh v
State of U.P., [1964] 1 SCR 332; Gobind v. State of
M.P. (1975) 2 SCC 148 : [1975] 3 SCR 946;
Association of Medical Super Speciality Aspirants and
Residents v. Union of India (2019) 8 SCC 607 : [2019]
12 SCR 1011; Vincent Panikurlangara v. Union of
India (1987) 2 SCC 165; ArunaRodrigues (4) v. Union
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of India (2011) 12 SCC 481; and Laxmi Raj Shetty v.
State of Tamil Nadu (1988) 3 SCC 319 : [1988] 3 SCR
706 - referred to.
Henning Jacobson v. Commonwealth of Massachusetts
197 US 11 (1905); Zucht v. King, 260 US 174 (1922);
Henry v. Hazzard [2021] NSWSC 1320; Ryan Yardley
v. Minister for Workplace Relations and Safety [2022]
NZHC 291; Roman Catholic Diocese v. Cuomo 141 S.
Ct. 63 (2020); South Bay United Pentecostal Church v.
Newsom 140 S. Ct. 1613 (2020); Kassam v. Hazzard;
Henry v. Hazzard [2021] NSWCA 299; Ministry of
Health v. Atkinson [2012] NZCA 184; Jane Roe v.
Henry Wade 410 US 113 (1973); Four Aviation Security
Service Employees v. Minister of COVID-19 Response
[2021] NZHC 3012 and Spencer v. Attorney General
of Canada [2021] FC 361 - referred to.
Case Law Reference
[2004] 1 Suppl. SCR 225
referred to
Para 11
[2011] 8 SCR 680
referred to
Para 13
[2013] 8 SCR 631
referred to
Para 13
[1990] 1 SCR 909
referred to
Para 13
[2007] 5 SCR 7
relied on
Para 14
[2007] 13 SCR 811
relied on
Para 15
(2021) 7 SCC 772
relied on
Para 15
(2001) 3 SCC 635
relied on
Para 21
(2009) 7 SCC 561
relied on
Para 21
[1974] 2 SCR 154
relied on
Para 22
(2001) 8 SCC 491
relied on
Para 23
[2018] 6 SCR 1
referred to
Para 28
[2011] 4 SCR 1057
referred to
Para 28
[2017] 10 SCR 569
referred to
Para 28
[2014] 5 SCR 119
referred to
Para 41
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[1998] 1 Suppl. SCR 723
referred to
Para 41
[1964] 1 SCR 332
referred to
Para 41
[1975] 3 SCR 946
referred to
Para 41
[2019] 12 SCR 1011
referred to
Para 43
(1987) 2 SCC 165
referred to
Para 55
[2018] 13 SCR 1286
referred to
Para 55
(2011) 12 SCC 481
referred to
Para 62
[1988] 3 SCR 706
referred to
Para 70
CIVIL ORIGINAL JURISDICTION : Writ Petition (Civil) No.607
of 2021.
(Under Article 32 of The Constitution of India)
Prashant Bhushan, Ms. Cheryl Dsouza, Advs. for the Petitioner.
Tushar Mehta, SG, K. M. Nataraj, Ms. Aishwarya Bhati, ASGs,
Amit Anand Tiwari, AAG, S. Guru Krishnakumar, Sr. Adv., Rajat Nair,
Kanu Agrawal, Ketan Paul, Mayank Pandey, Gurmeet Singh Makker,
Vipin Nair, P. B. Suresh, Sughosh Subramanyam, Arindam Ghosh, Agnish
Aditya, Shyel Trehan, Ms. Malvika Kapila, Ms. Bhagya Yadav, Ms.
Tanwangi Shukla, Shailesh Madiyal, Ms. Mrinal Gopal Elker, Kameshwar
Nath Mishra, Ms. Pratibha Yadav, Rahul Chitnis, Sachin Patil, Aaditya
A. Pande, Geo Joseph, Ms. Shwetal Shepal, Ms. Jyoti Mendiratta, Dr.
Joseph Aristotle S., Ms. Mary Mitzy, Ms. Devyani Gupta, Advs. for the
Respondents.
Ms. Meenakshi S. Kamble, Hitesh Kumar Sharma, Akhileshwar
Jha, Ms. Kavita S. More, Advs. for the Intervenors.
The Judgment of the Court was delivered by
L. NAGESWARA RAO, J.
1. The Petitioner was a member of the National Technical Advisory
Group on Immunization (NTAGI) and was advising the Government of
India on vaccines. He has filed this Writ Petition in public interest seeking
the following reliefs:
"(a) Direct the respondents to release the entire segregated
trial data for each of the phases of trials that have been
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undertaken with respect to the vaccines being administered
in India; and
(b) Direct the respondent No 2 to disclose the detailed minutes
of the meetings of the Subject Expert Committee and the
NTGAI with regard to the vaccines as directed by the
59thParliamentary Standing Committee Report and the
members who constituted the committee for the purpose of
each approval meeting; and
(c) Direct the respondent No.2 to disclose the reasoned
decision of the DCGI granting approval or rejecting an
application for emergency use authorization of vaccines and
the documents and reports submitted to the DCGI in support
of such application; and
(d) Direct the respondents to disclose the post vaccination
data regarding adverse events, vaccinees who got infected
with Covid, those who needed hospitalization and those who
died after such infection post vaccination and direct the
respondents to widely publicize the data collection of such
adverse event through the advertisement of toll free telephone
numbers where such complaints can be registered; and
(e) Declare that vaccine mandates, in any manner whatsoever,
even by way of making it a precondition for accessing any
benefits or services, is a violation of rights of citizens and
unconstitutional; and
(f) Pass any other orders as this Hon'ble Court deems fit."
2. In the Writ Petition, the Petitioner highlighted the adverse
consequences of emergency approval of vaccines in India, the need for
transparency in publishing segregated clinical trial data of vaccines, the
need for disclosure of clinical data, lack of transparency in regulatory
approvals, minutes and constitution of the expert bodies, imperfect
evaluation of Adverse Events Following Immunisation (AEFIs) and
vaccine mandates in the absence of informed consent being
unconstitutional. The Petitioner further stated in the Writ Petition that
coercive vaccination would result in interfering with the principle of
informed self-determination of individuals, protected by Article 21 of the
Constitution of India.
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3.