2026 INSC 218 W.P.(C) No.1220/2021 with connected matters Page 1 of 30

REPORTABLE

IN THE SUPREME COURT OF INDIA

CIVIL ORIGINAL JURISDICTION

WRIT PETITION (CIVIL) NO.1220 OF 2021

RACHANA GANGU & ANR. …PETITIONER (S)

VERSUS

UNION OF INDIA & ORS. …RESPONDENT(S)

WITH

CIVIL APPEAL NO………………….. OF 202 6

(ARISING OUT OF SLP(C) No. 16452 OF 2023)

AND

T.P.(C) No. 1716 OF 2023

AND

T.P.(C) Nos. 2289-2294 OF 2024

J U D G M E N T

VIKRAM NATH, J.

1. Leave granted in SLP(C) No. 16452/2023.

2. The COVID-19 pandemic was an unprecedented period of

suffering and disruption, which brought grief and

hardship to countless families across the country. Many

lives were lost, and many households were left to bear

sorrow that cannot easily be expressed in words. The

W.P.(C) No.1220/2021 with connected matters Page 2 of 30

present proceedings arise in the aftermath of that difficult

time. The Court approaches the issues raised with a deep

sense of empathy for the human loss endured during the

pandemic, while remaining mindful that the questions

before it must be examined with care and within the

constitutional limits of judicial determination.

3. At the outset, it is relevant to note that a writ petition

under Article 32 of the Constitution, registered as W.P.(C)

No. 1220 of 2021 (Rachana Gangu & Anr. v. Union of India

& Ors.), was instituted before the Supreme Court by

parents of young individuals who had received COVID-19

vaccination and are stated to have died thereafter. The

petition sought, inter alia, the constitution of an

independent expert medical board to inquire into such

deaths, the formulation of protocols for early detection and

treatment of adverse events following immunization

(AEFI), and the grant of compensation.

4. Subsequent thereto, writ petitions raising similar

grievances came to be filed before the High Court of

Kerala. One such petition was Sayeeda K.A. v. Union of

India & Ors. (W.P.(C) No. 17628 of 2022, High Court of

Kerala), wherein the petitioner sought directions for

recognition of a death allegedly following COVID-19

vaccination as an AEFI case and for the grant of

compensation to the dependants of the deceased. By an

W.P.(C) No.1220/2021 with connected matters Page 3 of 30

interim order dated 01.09.2022, the Kerala High Court

directed the Ministry of Health and Family Welfare and the

National Disaster Management Authority to formulate,

within a stipulated period, a policy for identification of

AEFI cases and for compensating the families of such

deceased persons.

5. Aggrieved by the aforesaid interim directions, the

respondents approached this Court in SLP(C) No.

16452/2023 challenging the interim order passed by the

High Court in Sayeeda K.A. v. Union of India & Ors.. A

Transfer Petition TP(C) No.1716/2023 was also field

seeking transfer of proceedings from the High Court to this

Court as the same issue was pending adjudication.

6. With respect to W.P.(C) Nos. 13487/2022, 13573/2022,

11276/2022, 35180/2022, 37055/2022 and

38961/2022 pending before the Kerala High Court where

similar prayers of compensation were made by the

petitioners, the respondent Union of India filed T.P.(C)

Nos. 2289-2294/2024 seeking transfer of these

proceedings before this Court. Consequently, the Article

32 writ petition, the proceedings arising from the Kerala

High Court, and the connected matters were listed

together for consideration. For ease of convenience,

W.P.(C) No. 1220 of 2021 is taken as the lead case. The

W.P.(C) No.1220/2021 with connected matters Page 4 of 30

disposal of this writ petition shall govern the disposal of

all connected matters.

7. A brief summary of facts giving rise to each case is as

follows:

i. Rachna Gangu & Anr. v. Union of India & Ors., W.P.(C)

No. 1220 of 2021

Petitioner’s younger daughter, aged 18 years, received

the first dose on 29.05.2021. Her platelet count

dropped, she had severe headache, and had a tingly

and numb feeling in her fingertips. Her condition

worsened and the petitioner was informed that her

daughter had been diagnosed with CVST - Cerebral

Venous Sinus Thrombosis. She passed away on

19.06.2021

Petitioner’s elder daughter, aged 20 years, received the

first dose of vaccine on 08.06.2021. She had high fever,

arthralgia, headache and myalgia. In the following

days, she developed Multisytem Inflammatory

Syndrome (MIS- C/A) She lost her life on 10.07.2021.

ii. Sayeeda K.A. v. Union of India & Ors. in W.P.(C)

17628/2022 before Kerala High Court

Husband Abdul Nazeer M.H. who was otherwise in

good health received his first dose of vaccine on

08.06.2021. On the same day at 03.03 p.m., he was

W.P.(C) No.1220/2021 with connected matters Page 5 of 30

declared dead. The post-mortem report did not reveal a

definite reason as to the cause of death, however it was

noted that the possibility of death due to Heart

Pathology following COVID-19 cannot be ruled out.

iii. Renjith R v. Union of India & Ors. in W.P.(C) No.

13487/2022 before Kerala High Court

Petitioner’s wife Mahima aged 31 years, received the

vaccine on 06.08.2021 and passed away on

20.08.2021. She was pregnant with twins at that time.

She died of Thromobocytopenia. The cause of death as

classified by the respondent was AEFI.

iv. Jean George v. Serum Institute of India Limited & Ors.

in W.P. (C) No. 13573/2022 before Kerala High Court

Nova Sabu, aged 19 years, was the only daughter of the

petitioner. She took the vaccine on 28.07.2021. She

passed away on 12.08.2021. The cause of her death as

mentioned in the post-mortem report was ‘intra cranial

bleeding of brain’. She had no history of neurological

illness.

v. Rajagopalan K v. Union of India & Ors. in W.P. (C) No.

11276/2022 before Kerala High Court

Petitioner took the first dose of vaccine on 08.02.2021.

Following that, he developed fever and his situation

W.P.(C) No.1220/2021 with connected matters Page 6 of 30

worsened. He was ultimately diagnosed with limbic

encephalitis along with ‘systematic inflammatory state

in the form of deranged coagulation parameter. It was

diagnosed as a probable auto immune encephalitis

following post COVID-19 vaccination.

vi. Ginu G Kumar v. Serum Institute of India Ltd. & Ors. in

W.P.(C) No. 35180/2022 before Kerala High Court

Petitioner’s wife, aged 37 years, was vaccinated on

02.08.2021. She was declared dead on 23.08.2021 and

the cause of her death was ‘intra cerebral

haemorrhage’. The medical report revealed she had

thrombosis with thrombocytopenia syndrome, which is

a complication of Covishield vaccine, although rare.

vii. Ansaria AK v. Union of India & Ors. in W.P. (C) No.

37055/2022 before Kerala High Court

Petitioner’s husband took the vaccine on 13.03.2021.

He developed a high fever after that and the doctors

could not pinpoint the exact cause for the problem. He

eventually suffered from paralysis. Neurologist’s report

arrived at the conclusion that patient had been

paralyzed due to the administration of Covishield

vaccine.

W.P.(C) No.1220/2021 with connected matters Page 7 of 30

viii. Narayan`an MV & Anr. v. Serum Institute of India Ltd.

& Ors. in W.P. (C) No. 38691/2022 before Kerala High

Court

Petitioner’s elder daughter, aged 18 years, received the

vaccine on 26.10.2021. She developed a mild fever and

continuous headache following it. She was admitted to

the hospital. She ultimately passed away on

06.11.2021. Thrombotic Thrombocytopenia was

identified as the cause of her death.

8. It is in this factual and procedural backdrop that the

Court is called upon to examine the legality and propriety

of the interim directions issued by the Kerala High Court,

as well as the extent to which judicial intervention is

warranted in matters touching upon adverse events

following immunization, compensation, and public health

policy.

Submissions

9. The submissions advanced on behalf of the appellants are

summarised hereunder.

9.1 Learned counsel for the appellants have argued at

length highlighting the Union Government’s failure to

ensure transparency, informed consent and pos t-

vaccination surveillance, thereby constituting a

violation of Article 21 of the Constitution. They allege

that deaths caused after the administration of COVID-

W.P.(C) No.1220/2021 with connected matters Page 8 of 30

19 vaccines expose structural defects in India’s

vaccine governance regime.

9.2 It is submitted that the respondents’ contention that

vaccination was entirely voluntary is incorrect.

According to them, public communication and

administrative measures created an atmosphere of

effective compulsion. It is urged that restrictions were

imposed upon unvaccinated individuals, including

limitations on travel and access to certain public

spaces and services, thereby pressuring citizens to

undergo vaccination irrespective of their autonomy or

informed consent.

9.3 Appellants contend that a significant body of scientific

evidence had emerged linking AstraZeneca vaccine, of

which Covishield is a version, to fatal blood clotting

disorders (VITT/TTS). By March-April 2021, around

18 European countries had suspended or restricted

its administration, limiting its use to older age groups

due to multiple vaccine-induced deaths. It is alleged

that the Government, despite having exclusive

possession of facts essential for decision making, did

not either publish causality assessments or maintain

a publicly accessible portal, which is in clear violation

of the expectation recorded by this Court in Jacob

Puliyel v. Union of India. This control by the

W.P.(C) No.1220/2021 with connected matters Page 9 of 30

Government over AEFI data, combined with non -

disclosure of serious adverse events, deprived citizens

of information crucial to make an informed decision.

9.4 The appellants further allege that, despite possessing

relevant information regarding potential adverse

effects, the respondents failed in their duty to

adequately warn users, caregivers, and the medical

community about known serious side effects. It is

specifically contended that the Drug Controller

General of India publicly stated on 04.01.2021 that

the vaccines were “110% safe,” which, according to

the appellants, contributed to a false sense of absolute

safety and undermined informed consent.

9.5 They ultimately highlight that the non-disclosure of

voluntariness, lack of truthful risk communication,

investigative lapses in monitoring AEFI, denial of

access to medical records, absence of diagnostic

protocols and non -publication of causality

assessments has led to the violation of Articles 14,

19(1)(a) and 21 of the Constitution. It was argued that

many individuals had lost their lives, and many

families their sole breadwinners. For the large number

of similarly placed vaccine-injured citizens, it was

submitted, formation of a policy which ensures grant

W.P.(C) No.1220/2021 with connected matters Page 10 of 30

of fair and timely compensation would secure a life of

dignity.

10. Per contra, leaned counsel for the respondent s have

strongly opposed the submissions made on behalf of the

appellants and made the following submissions:

10.1 That the safety of COVID-19 vaccines and their

regulatory approval was in accordance with the

statutory procedure prescribed under the law and the

same was examined in detail by this Court in Jacob

Puliyel. The vaccine was given marketing approval by

the CDSCO (Central Drugs Standard Control

Organisation). Following that, NTAGI (National

Technical Advisory Group of Immunization), which is

the apex advisory body on immunization, compiled

the scientific evidence on the vaccine, and the same

was sent to the COVID-19 Working Group. In order to

oversee all aspects of vaccine administration, the

Government constituted the National Expert Group

on Vaccine Administration for COVID-19 (NEGVAC),

which provided the final layer of expert review for

recommendations related to the vaccine. This is a

testament to the fact that the vaccines have gone

through a rigorous regulatory approval process with

multifarious approval processes including reviews by

independent experts. They also averred that this

W.P.(C) No.1220/2021 with connected matters Page 11 of 30

Court has found the approval of COVID-19 vaccines

to be in accordance with law.

10.2 That the system of AEFI surveillance, monitoring and

investigation is administered by leading scientific and

medical experts. The AEFI Committees are created at

the State and Central level to provide guidance to the

program and carry out documentation, investigation

and causality assessment. An AEFI can be reported

by any person, on the CoWIN portal or otherwise to

the District Immunization Officer (DIO). For all severe

and serious AEFI cases, causality assessment is

conducted by trained medical experts of the State or

National AEFI Committee. It was also submitted that

considering the novel nature of the virus, the

Committee was expanded to include cardiologists,

neurologists, respiratory medicine specialists and

other medical specialists. With respect to the causality

assessment, it was submitted that result of the same

was made public and was available on the website of

Ministry of Health and Family Welfare (MoHFW). The

Operational Guidelines shared with the States and the

Union Territories clearly recommended that the

vaccine beneficiaries should be informed about the

benefits and side-effects alike. Posters with

information on the risks involved were also prepared

W.P.(C) No.1220/2021 with connected matters Page 12 of 30

in English and Hindi, which were to be displayed in

all vaccination centres across the country.

10.3 That the occurrences of Thromboemolic events (TTS),

which were identified as an AEFI, were very miniscule.

It was submitted that in India, as compared to other

European countries, occurrence of TTS was a rare

event since different populations react differently to

different vaccines due to genetic variations. In India,

the reporting rate of TTS was 0.001 per one lakh

doses, making it an extremely rare occurrence. It was

further submitted that the existing mechanism for

monitoring, investigation and analysis of AEFIs is

adequate, effective and transparent. It was strongly

urged that if an independent review of AEFI is allowed,

then that would plant a seed of doubt in the existing

regulatory system and harm public interest.

10.4 That a claim for compensation for an AEFI related

death does not lie under writ jurisdiction. It was

contended that a claim can be made at two stages-

first, during the clinical trial stage, where the vaccine

manufacturer is under a legal obligation to provide

treatment to the trial participant in case of an injury

or death; second, at the vaccine administration stage,

in case of an untoward incident, appropriate remedies

are available in law to the vaccine beneficiary or their

W.P.(C) No.1220/2021 with connected matters Page 13 of 30

family. This includes approaching consumer courts

seeking damages for negligence, malfeasance or

misfeasance, which is determined on a day -to-day

basis. It was brought to our attention that unlike

other countries where vaccine manufacturers have

legal immunity from such claims, the manufacturers

here do not have any legal immunity whatsoever.

Therefore, all those aggrieved can approach the

consumer courts and pursue their claims.

Issues

11. Having heard the learned counsel for the parties at length

and examined the submissions placed on record, the

broad issues that have arisen for our determination are as

follows:

i. Whether the absence of a uniform policy governing

compensation in cases of death or injury following

administration of COVID-19 vaccination results in

violation of Right to Life protected under the

Constitution?

ii. If yes, can this Court direct the respondents to frame

a policy in that regard?

Analysis

12. At the outset, we would like to reiterate that the petitions

before us raise serious questions of violation of

W.P.(C) No.1220/2021 with connected matters Page 14 of 30

fundamental rights, more particularly that of right to life.

The respondent Union of India has urged that the

questions raised by the appellants traverse into a realm of

scientific inquiry, and that the individuals aggrieved by

the adverse outcomes have the door of private remedies

open for them. The Court is conscious that questions of

public health, governance, vaccine approval and element

of causality involve complex technical considerations, and

that the constitutional courts must exercise appropriate

restraint in domains entrusted exclusively for

determination by the executive branch.

13. At the same time, a closer look at the petitions reveals that

the question is not just confined to the adjudication of

individual cases. The grievance here is much deeper,

namely, that families alleging grave harm during the

course of State-led vaccination program are left without

any uniform remedy to seek redressal.

Extension of the Right to Health

14. It is well settled that Article 21 is not limited to protection

against unlawful deprivation; of life, but also includes

within its ambit a wide range of other rights that facilitate

the smooth operation of right to life. Right to health and

bodily integrity, is one such right. This Court has not

shied away from upholding this constitutional idea and

recognizing that the State bears a positive obligation to

W.P.(C) No.1220/2021 with connected matters Page 15 of 30

safeguard health of its people and ensure conditions

necessary for meaningful enjoyment of life.

15. In the aftermath of the unfortunate Bhopal Gas Tragedy,

this Court had expressed its anguish at the plight of the

affected persons and noted the absence of a coordinated

and effective effort to provide timely care and redress to

them. It was noted:

“9. It is indeed a matter for national

introspection that public response to this

great tragedy which affected a large

number of poor and helpless persons

limited itself to the expression of

understandable anger against the

industrial enterprise but did not channel

itself in any effort to put together a public

supported relief fund so that the victims

were not left in distress, till the final

decision in the litigation.”

10. This Court, considered it a compelling

duty, both judicial and humane, to secure

immediate relief to the victims. In doing

so, the court did not enter upon any

forbidden ground. Indeed, efforts had

earlier been made in this direction by

Judge Keenan in the United States and

by the learned District Judge at Bhopal.

What this court did was in continuation of

what had already been initiated.”

1

16. The jurisprudence of this Court has progressively evolved

from recognising the right to health as a facet of the right

1

Union Carbide Corpn. v. Union of India, (1989) 3 SCC 38.

W.P.(C) No.1220/2021 with connected matters Page 16 of 30

to life under Article 21 in Parmanand Katara v. Union

of India

2 to emphasising the positive duty of the State to

act as provider, facilitator, and regulator in all aspects of

healthcare. In State of Punjab v. Mohinder Singh

Chawla,

3 this Court had reiterated that “it is now settled

law that right to health is integral to the right to life.

Government has a constitutional obligation to provide

health facilities.” Again, in State of Punjab v. Ram

Lubhaya Bagga,

4 this Court observed that “the State can

neither urge nor say that it has no obligation to provide

medical facility. If that were so, it would be ex facie violative

of Article 21”.

17. The Court therefore approaches the present proceedings

with the limited objective of examining, whether in the

exceptional context of a pandemic response, the absence

of any structured framework to address serious adverse

events raise constitutional concerns warranting an

institutional response. In doing so, we reiterate that we

are neither adjudicating upon the vaccine efficacy nor

sitting in scientific review over the regulatory approval

process. The question is confined to whether the State’s

welfare obligations require the exploration of an equitable

2

(1995) 3 SCC 248.

3

(1997) 2 SCC 83.

4

(1998) 4 SCC 117.

W.P.(C) No.1220/2021 with connected matters Page 17 of 30

mechanism of redressal for harm arisen in the course of a

national public health intervention.

18. This Court in Distribution of Essential Supplies and

Services During Pandemic, In re

5 specifically talked

about special duty cast on the executive in times of

emergency such as this and the subsequent duty of the

Court in ensuring that the executive acts within the

constitutional boundaries. The relevant portion is

extracted below:

“16. Similarly, courts across the globe

have responded to constitutional

challenges to executive policies that have

directly or indirectly violated rights and

liberties of citizens. Courts have often

reiterated the expertise of the executive in

managing a public health crisis, but have

also warned against arbitrary and

irrational policies being excused in the

garb of the “wide latitude” to the

executive that is necessitated to battle a

pandemic. This Court in Gujarat Mazdoor

Sabha vs State of Gujarat,

6 albeit while

speaking in the context of labour rights,

had noted that policies to counteract a

pandemic must continue to be evaluated

from a threshold of proportionality to

determine if they, inter alia, have a

rational connection with the object that is

sought to be achieved and are necessary

to achieve them.”

5

2021 SCC OnLine SC 372.

6

AIR 2020 SC 4601, para 9.

W.P.(C) No.1220/2021 with connected matters Page 18 of 30

19. This Court does not proceed on the premise that the

regulatory approval process or the vaccination programme

was unlawful or deficient. The measures were undertaken

in extraordinary circumstances with the objective of

protecting public health. As submitted by the

respondents, this has already been dealt with by the Court

in Jacob Puliyel v. Union of India.

7 The relevant portion

is extracted below:

“117. An analysis of the submissions

made by the learned counsel appearing

for the parties and a close scrutiny of the

material placed on record would show

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

7

2022 SCC OnLine SC 533.

W.P.(C) No.1220/2021 with connected matters Page 19 of 30

minutes of the meetings of the SEC,

available on the website of the MoHFW.

118. We do not agree with the

submission on behalf of the petitioner

that emergency approvals to the

vaccines were given in haste, without

properly reviewing the data from clinical

trials.”

20. However, the Constitution does not view the right to life

solely through the lens of fault. Article 21 also embodies a

positive obligation of the State to ensure that where grave

harm is alleged to have occurred in the course of a State-

led public health intervention, affected families are not left

without any accessible mechanism of redress. The

absence of such an institutional framework raises

constitutional concerns which warrant a calibrated

response.

21. The Union of India has submitted that question of

causality between the vaccination and the resultant

deaths involve scientific assessment. They also admit that

such an assessment has been conducted by them and no

relation has been found between the two. This Court in

Jacob Puliyel did a detailed examination of the AEFI

surveillance system in India and recorded the following:

“132. From the material placed before us,

we note that the National AEFI

Surveillance Secretariat has been

W.P.(C) No.1220/2021 with connected matters Page 20 of 30

functioning for 10 years and as has been

pointed out, there is a well-established

protocol in place for identification and

monitoring of AEFIs. The website of the

MoHFW carries the results of causality

assessment of AEFI cases, from which the

public can obtain relevant information

pertaining to AEFIs. We have been

informed that a thorough causality

assessment analysis of AEFIs is carried

out by experts and not every severe

disease and death can be attributed to

vaccination. Reactions are examined by

experts specifically trained to undertake

causality analysis before notifying such

reactions as adverse events arising from

vaccination. There is a well -defined

mechanism for collection of data relating to

adverse events that occur due to COVID-19

vaccines and the Government of India has

taken steps to direct all medical

professionals concerned at the ground

level to report adverse events. Even

medical practitioners at private hospitals

are associated with reporting of adverse

events. Therefore, we are not inclined to

accept the broad strokes challenge

mounted by the petitioner that the

surveillance system of AEFIs in this

country is faulty and the correct figures of

those who have suffered any side effects,

severe reactions or deaths post inoculation

have not been disclosed.”

22. It has come to our notice that extensive studies conducted

by Indian Council of Medical Research (ICMR) and

W.P.(C) No.1220/2021 with connected matters Page 21 of 30

National Centre for Disease Control (NCDC) have affirmed

that there is no direct link between the vaccines and

sudden deaths caused thereafter. They have concluded

that the vaccines are safe with extremely rare instances of

side effects.

8 This court accords due weight to such

scientific findings. At the same time, the expression

‘Adverse Event Following Immunization’ (AEFI), as

recognized by the World Health Organization (WHO)

denotes any untoward medical occurrence after

vaccination which does not necessarily have a causal

relationship with the vaccine itself.

9

23. This Court does not consider it e ither feasible or

appropriate, in a writ jurisdiction, to embark upon a

scientific determination of causality in individual cases.

Such questions are better left to be answered by domain

experts. Nevertheless, the Court’s inability to undertake

scientific inquiry does not exhaust its constitutional

enquiry.

8

Extensive studies by ICMR and AIIMS on sudden deaths among

adults post COVID have conclusively established no linkage between

COVID-19 vaccines and sudden deaths, PRESS INFORMATION BUREAU,

<https://www.mohfw.gov.in/?q=en/pressrelease/extensive-

studies-icmr-and-aiims-sudden-deaths-among-adults-post-covid-

have>.

9

WORLD HEALTH ORGANIZATION, Causality Assessment of An Adverse

Event Following Immunization,

<https://iris.who.int/server/api/core/bitstreams/88d3e61d-

63e5-458c-8880-893f713226d1/content.>.

W.P.(C) No.1220/2021 with connected matters Page 22 of 30

24. The Constitution does not conceive of the State as a

distant spectator to human suffering, but as an active

guardian of welfare and dignity. The Directive Principles of

State Policy illuminate this vision with clarity. Article 41

speaks of public assistance in cases of sickness and

disablement, within the limits of State’s capacity. Article

47 declares the improvement of public health to be among

the State’s primary duties.

25. The vaccination program undertaken during the

pandemic was itself an expression of these constitutional

commitments. The State went above and beyond in order

to create a vaccination scheme and the same undoubtedly

helped save many lives. But at the same time, as the

government data itself suggests, it cannot be brushed

aside that the same vaccines also led to loss of life. In such

a situation, it is not appropriate that the State shrugs its

responsibility in coming to aid to those affected families

who have lost their near and dear ones.

26. The Union has urged that individuals aggrieved by adverse

outcomes may seek remedies before civil courts or

consumer fora on the grounds of negligence -based

principles. While such remedies do exist, the Court is of

the view that they are ill-suited as the only pathway of

redress in the context of a mass immunization program.

Vaccine injury claims raise questions where scientific

W.P.(C) No.1220/2021 with connected matters Page 23 of 30

attribution is often complex. To insist upon proof of

negligence and fault in each case would impose an

onerous burden upon affected families and would not be

the best solution to those left affected. Further, a

multiplicity of individual proceedings risks inconsistent

outcomes and unequal access to relief, thereby

undermining the guarantee of equality under Article 14.

27. In such a setting, the relationship between the individual

and the State cannot be viewed through the prism of fault-

based liability. Where the State undertakes an

intervention of this scale in discharging of its duty to

protect public health, the right to health under Article 21

would automatically extend to a corresponding obligation

of institutional support in cases of grave outcomes, no

matter how rare they are.

No-Fault Compensation

28. The principle of no-fault liability is not alien to Indian law.

Section 164 of Motor Vehicles Act, 1988 stipulates a fixed

liability of the owner even though the accident was caused

without any fault of her own, subject to certain conditions.

The rationale behind it is simple- certain categories of

harm require swift relief without prolonged inquiry into

fault.

29. Even across the world in many jurisdictions, no-fault

vaccine injury compensation scheme is a recognized

W.P.(C) No.1220/2021 with connected matters Page 24 of 30

feature of a welfare-state response. Some policies are

listed below:

i. Australia, which did not have a no-fault vaccine injury

compensation program already in place, introduced a

comprehensive policy on COVID-19 vaccination

compensation called the ‘COVID-19 Vaccine Claims

Scheme Policy 2021’. It lays out the basis on which

the government may make a grant of financial

assistance to a person who submits a claim for

compensation. It covers losses or expenses arising

from administration of a COVID-19 vaccine or an

adverse effect which is recognized as vaccine-related.

The scheme recognises graded categories of injury,

including death, and provides structured

compensation covering medical expenses, loss of

earnings, dependency benefits, and funeral costs.

ii. Similarly, the United Kingdom, which already had a

no-fault compensation scheme for vaccines,

incorporated COVID-19 vaccines into the scheme

from 31 December 2020. The scheme is administered

by the NHS Business Services Authority and funded

by the government. It covers vaccine recipients, their

representatives, or estates at no cost to file claims.

iii. The World Health Organization’s COVID-19 Vaccines

Global Access (COVAX) initiative which covered low

W.P.(C) No.1220/2021 with connected matters Page 25 of 30

and middle-income countries also had a No-Fault

Compensation Program which provided a lump sum

compensation to eligible individuals who suffered

from adverse events after receiving the vaccine

distributed through the COVAX Facility till 30 June

2022.

iv. Japan had a no -fault compensation scheme for

vaccine related injuries since 1976, and it added

COVID-19 vaccines as ‘temporary vaccinations’ after

a 2020 amendment. It covers a wide range of adverse

reactions related to COVID-19 vaccines.

30. It is evident from the policies adopted internationally that

Governments have acknowledged the need to address

vaccine-related injuries through dedicated compensation

mechanisms. Such programmes provide an expeditious

and fair avenue of relief, obviating the necessity for

affected persons to be relegated to the labyrinthine

processes in order to secure enforcement of their claims.

31. In contrast, as matters stand today, India does not appear

to have in place any uniform or structured policy

mechanism to provide redress to individuals who suffer

adverse effects following vaccination. This gap cannot be

lightly overlooked, particularly w hen vaccination

programmes are undertaken as public health measures

under the aegis and authority of the State itself. The

W.P.(C) No.1220/2021 with connected matters Page 26 of 30

concern becomes all the more pressing in the context of

the COVID-19 pandemic, where immunisation was carried

out on an unprecedented scale as a collective societal

necessity. In such a situation, the State cannot be heard

to say that those who experience serious adverse

consequences must fend for themselves, without any clear

or accessible avenue of relief. The absence of a coherent

framework, therefore, calls for timely intervention, lest the

rights of such persons remain only theoretical and without

meaningful enforcement.

32. It must also be acknowledged that, from the onset of the

pandemic, efforts were undertaken at every level of

governance to mitigate the impact of the pandemic. This

Court, at the beginning took suo moto cognizance of the

situation in Distribution of Essential Supplies and

Services During Pandemic, In re

10 which led to the

development of a national policy, the issues of oxygen

supply, drugs, administration and pricing of vaccines were

also adjudicated upon. Similarly in Gaurav Kumar

Bansal v. Union of India in W.P.(C) No. 539/2021, this

Court had directed the National Disaster Management

Authority to frame appropriate guidelines for ex-gratia

assistance to families of persons who died due to COVID-

19. The Court recognized that while the design of the

10

Supra note 5.

W.P.(C) No.1220/2021 with connected matters Page 27 of 30

policy lies within the executive domain, the absence of any

structured framework of relie f in exceptional

circumstances affecting life and dignity may warrant a

limited institutional response.

33. That said, this Court has time and again also reiterated

that the executive, which has been democratically elected

by the people of the country and is accountable for its

actions to them, is vested with the competence and

authority to draft policies. But at the same time, this

constitutionally protected separation of powers cannot in

any scenario come in the way of Judiciary when the

fundamental rights of its citizens are violated due to

executive policies, or by lack of them, as in this case. In

such circumstances, the constitutional duty of this Court

to safeguard the rights of citizens cannot be eclipsed.

34. This Court, in Jacob Puliyel, underscored the

responsibility of the State in monitoring adverse events

following immunisation. In our considered view, that

responsibility cannot end at surveillance alone, but must

extend to providing fair compensation to those who

suffered vaccine-related injury, in light of the discussion

above.

35. In addition to this, to allay the concerns of the appellants

regarding the inefficiency in monitoring AEFIs, w e

reiterate that the Union of India shall continue to ensure

W.P.(C) No.1220/2021 with connected matters Page 28 of 30

that surveillance of adverse events following immunisation

(AEFI) is carried out through efficient monitoring

mechanisms, and that relevant data is placed in the public

domain in a transparent and timely manner. This is

consistent with the observation of this Court in Jacob

Puliyel which is produced hereinbelow:

“144.8. We are also of the opinion that

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.”

36. With respect to the issue regarding forming an

independent expert board to look into the deaths caused,

we are satisfied with the submissions made by the

W.P.(C) No.1220/2021 with connected matters Page 29 of 30

respondent that a framework already exists consisting of

National and State AEFI Committees which investigate

into the deaths and injuries caused after the

administration of vaccines. As discussed before, this court

is not sitting in a scientific inquiry into the question of

causation. In our opinion, this mechanism is adequate

and there is no need to conduct any independent inquiry

into the individual cases of deaths. In the absence of any

material indicating that such mechanisms are non -

functional or incapable of performing their role, it would

not be appropriate for this Court, in exercise of its writ

jurisdiction, to constitute a parallel body to undertake

individual medical determinations.

37. In view of the foregoing discussion, and having regard to

the limited constitutional concerns which arose for

consideration, the Union of India, through the Ministry of

Health and Family Welfare is hereby directed to

expeditiously formulate and place in the public domain an

appropriate no-fault compensation framework to address

serious adverse events following immunisation) arising in

the context of COVID-19 vaccination.

Conclusion

38. In the end, the following directions are issued:

i. The Union of India shall, through the Ministry of

Health and Family Welfare, frame a no -fault

W.P.(C) No.1220/2021 with connected matters Page 30 of 30

compensation policy for serious adverse events

following COVID-19 vaccination.

ii. The existing mechanisms for monitoring adverse

events following immunisation shall continue, and

relevant data shall be periodically placed in the public

domain in accordance with the observations in Jacob

Puliyel.

iii. No separate court -appointed expert body is

considered necessary in view of the existing

mechanisms for scientific assessment of adverse

events following immunisation.

iv. It is clarified that this judgment shall not preclude any

person from pursuing such other remedies as may be

available in law. Equally, the formulation of the no-

fault framework shall not be construed as an

admission of liability or fault on the part of the Union

of India or any authority.

39. Accordingly, the writ petition and other connected matters

are disposed of.

………………………………..J.

[VIKRAM NATH]

………………………………..J.

[SANDEEP MEHTA]

NEW DELHI;

MARCH 10, 2026