TEAM # 09

3RD INTRA COLLEGE MOOT COURT COMPETITION

BEFORE

THE HONORABLE HIGH COURT OF STATE OF RARA

UNDER BHARTIYA NYAYA SANHITA, 2023

UNDER CONSUMER PROTECTION ACT, 2019
UNDER DRUGS AND COSMETICS ACT, 1940
UNDER DISASTER MANAGEMENT ACT, 2005

(ORIGINAL JURISDICTION)

BETWEEN

AAROGYA TIWARI -
PETITIONER -1
V.
PHARMAGENIX -
RESPONDENT 1
UNION OF RARA REP. BY ITS GEN. SECRETARY - RESPONDENT 2

WRITTEN SUBMISSIONS OF RESPONDENTS

 3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

TABLE OF CONTENTS

1. TABLE OF CONTENTS...................................................................................................ii

2. LIST OF ABBREVIATIONS..............................................................................................iii-iv

3. INDEX OF AUTHORITIES............................................................................................vi-viii

4. STATEMENT OF JURISDICTION.......................................................................................ix

5. STATEMENT OF FACTS..................................................................................................x-x

6. ISSUES RAISED.................................................................................................................xi

7. SUMMARY OF ARGUMENTS..........................................................................................xii

8. ARGUMENTS ADVANCED...........................................................................................13-21

1. THE WRIT PETITION BY THE PETITIONER BEFORE THE HC IS NOT

MAINTAINABLE…………………………………………………………………………....12

1.1.1. THE PETITIONER HAS ALTERNATIVE REMEDY AVAILABLE AGAINST DR. CHUCKLES
CLINIC FOR THEIR LOSS………………………...
………………………………………………….13

1.2. THE W.P. FILED AGAINST PUBLIC PART IS NOT MAINTAINABLE................................14

1.3. JUDICIARY MUST SUPPORT WITH THE EXECUTIVE’S POLICY MAKING DECISIONS…………...14

2. WHETHER PHARMAGENIX BREACHED ANY DUTY OF CARE OR NOT?......................................15

2.1. PHARMAGENIX HAS TAKEN DUE CARE IN DEVELOPING SAFE AND EFFECTIVE VACCINATION

………………………………………………………………………………………….15

2.2. PHARMAGENIX VACCINE MIGHT NOT BE THE ONLY CAUSE FOR THE DEATH OF THE PETITIONER

…………………………………………………………………………………………... 16
3. WHETHER VAXMAX WAS DEFECTIVELY DESIGNED OR MANUFACTURED ……...….
………..17
3.1. VAXMAX IS DESIGNED EFFECTIVELY MAKING IT REASONABLY SAFE ……………….……….18
4. WHETHER EUA ABSOLVES PHARMEGENIX
LIABILITY.............................................................19

4.1. EUA PROCESS IS SAFE AND ONTO THE MARK……...

………………………………………….20

ii
MEMORIAL ON BEHALF OF RESPONDENTS
 3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

4.2. GOVERNMENT DID NOT FASTRACK THE PROCESS……………………...

………………….......20

9. PRAYER……………………………………………………………………………………………………...21

iii
MEMORIAL ON BEHALF OF RESPONDENTS
 3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

LIST OF ABBREVIATIONS

S. ABBREVIATIONS FULL FORM

No
1. & and
2. § Section
3. ¶ Paragraph
4. ABDG All Bindia Distributors Guild
5. AEFIs Adverse Event Following Immunization
6. AIR All India Reporter
7. AIIMS All India Institute of Medical Sciences
8. Anr. Another
9. Art. Article
10. BNS Bhartiya Nyaya Sanhita, 2023
11. C. Govt. Central Government
12. CDC Centre for Disease control and prevention
13. CDSCO Central Drugs Standard Control
Organization
14. Cl. Clause
15. CONST Constitution of India para-Materia to Rara
16. Covid- 19 Corona Virus Disease of 2019
17. DM Act Disaster Management Act 2005
18. DCGI Drugs Controller General of India
19. E.g. Example

20. ed. Edition

21. Etc Et Cetera
22. FR Fundamental Right
23. GO Government Order
24. GCP Good Clinical Practices
25. Govt Government
26. HC High Court
27. Hon’ble Honorable
28. ICU Intensive Care Unit
29. ICMR Indian Council of Medical Research
30. i.e. That is

iv
MEMORIAL ON BEHALF OF RESPONDENTS
 3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

31. MoHFw Ministry of Health and Family Welfare

32. Ltd Limited
33. NSS National sample survey
34. No. Number
35. Ors. Others
36. PIL Public Interest Litigation
37. PTC Private Limited company
38. Pvt Private
39. PvPI Pharmacovigilance Programme of India
40. r/w Read with
41. S. Section
42. SARS-COV-2 Severe Acute Respiratory Syndrome
Coronavirus 2
43. SAGE Strategic Advisory Group of Experts on
Immunization
44. S/d Signature with Date
45. SC Supreme Court
46. SCC Supreme Court Cases
47. SCR Supreme Court Reporter
48. Sec. Section
49. TAG-VE Technical Advisory Group on Virus
Evaluation
50. u/A Under Article
51. UK-MHRA United Kingdom’s Medicines and
Healthcare Products
52. UNICEF United Nations Children’s Emergency
Fund
53. UOI Union of India
54. v. versus
55. VOC Variants of Concern
56. Vs. Versus
57. VAERS Vaccine Adverse Event Reporting System
58. WHO World Health Organization
59. WP Writ Petition
60. w.r.t. With respect to

v
MEMORIAL ON BEHALF OF RESPONDENTS
 3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

INDEX OF AUTHORITIES
S.No. CASES REFERRED PG.NO.
1. ASULAL LOYA VS. UNION OF INDIA, 2008 SCC ONLINE DEL 838 14

2. ACADEMY NUTRITION IMPROVEMENT VS. UNION OF INDIA 13

3. BOLAM V. FRIERN HOSPITAL MANAGEMENT COMMITTEE (1957) 1 WLR 582- 17

17

4. DDA VS JOINT ACTION COMMITTEE, (2008) 2 SCC 672. -15 15

5. ERBIS ENG’G CO. LTD. V. STATE OF WEST BENGAL, 2011 SCC 13

ONLINE CAL 835

6. JACOB PULIYEL V. UNION OF INDIA & ORS. LNIND 2022 SC 309 Comp. 4

7. JEAN GEORGE & ANR. V. SERUM INSTITUTE OF INDIA LTD. & ORS. Comp. 5

8. JACOBSON VS MASSACHUSETTS, 197 U.S. 11 (1905) 15

9. RADHA KRISHNA INDUSTRIES V. STATE OF HIMACHAL PRADESH AND ORS, Comp. 3

(2021) 6 SCC 771

10. SERUM INSTITUTE OF INDIA PVT. LTD. AND ORS. V. YOHAN TENGRA Comp. 5

& ORS. LNIND 2023 BOM 368

11. S S P GUPTA V. UNION OF INDIA, AIR 1982 SC 149.- 13 13

12. SUBHASH KUMAR V. STATE OF BIHAR, AIR 1991 SC 420 Comp. 8

vi
MEMORIAL ON BEHALF OF RESPONDENTS
 3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

S.No. CONSTITUTIONS
1. THE CONSTITUTION OF INDIA, 1950
2. THE CONSTITUTION OF RARA

S. NO. BOOKS REFERRED

1. A V DICEY, The Law of Constitution, (2nd ed., Palgrave Macmillan UK 1885)
2. D.D. BASU, Commentary on the Constitution of India, (35th ed., LexisNexis2017.)
3. H.M. SEERVAI, Constitutional Law of India, (4th ed., Lexis Nexis, 2015)
4. J.N. PANDEY, Indian Constitution, (12th ed., Central Law Agency,2013)
5. MODI: A TEXTBOOK OF MEDICAL JURISPRUDENCE AND TOXICOLOGY, (27th ed.,
Lexis Nexis, 2021)

S. NO. STATUTES AND CODES

1. THE BHARATIYA NYAYA SANHITA, 2023 NO. 45 OF 2023.
2. THE CONSUMER PROTECTION ACT, 2019 NO. 35 OF 2019.
3. THE DRUGS AND COSMETICS ACT, 1940 NO. 23 OF 1940.
4. THE DISASTER MANAGEMENT ACT, 2005 NO. 53 OF 2005.

S. NO GOVERNMENT DOCUMENTS FOR REFERENCE

1. APPROVED COVID-19 VACCINES AS ON 04-10-2022 BY MOFHW

2 FAQ’S ON COVID-19 VACCINE’S AND VACCINATION PROGRAM RELEASED BY

MOFHW AD OF 07 AUGUST 2021
3 EMERGENCY USE LISTING BY WHO AS OF 02 DECEMBER 2022

vii
MEMORIAL ON BEHALF OF RESPONDENTS
 3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

S.NO ONLINE RESOURCES

1. HeinOnline, https://home.heinonline.org/ (last accessed on June 28, 2024).
2. JSTOR. www.jstor.org (last accessed on June 28, 2024).
3. Lexis India, https://www.lexisnexis.com/in/legal/ (last accessed on June 28, 2024).
4. Manupatra, http://www.manupatrafast.com (last accessed on June 28, 2024).
5. SCC Online, http://www.scconline.com/(last accessed on June 28, 2024).
6. Westlaw India, http://www.westlawindia.com/(last accessed on June 28, 2024).

S.NO MISCELLANEOUS

1. THE 3 RD
INTRA COLLEGE MOOT COURT COMPETITION, 2024, MOOT PROPOSITION

viii
MEMORIAL ON BEHALF OF RESPONDENTS
 3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

STATEMENT OF JURISDICTION

AAROGYA TIWARI V. PHRAMAGENIX & ORS

[W.P. NO: /2022]

The petitioner found it convenient to approach the High Court of Rara under
Art.226 of the Constitution of Rara in the form of Writ Petition. The respondents humbly
submit to the jurisdiction of the Hon’ble High Court which has been invoked by the
petitioners.

This memorandum sets forth the facts, laws, and the corresponding contentions or
the arguments on which the claims are based in the instant case.

ix
MEMORIAL ON BEHALF OF RESPONDENTS
 3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

STATEMENT OF FACTS

A. BACKGROUND OF THE PROBLEM

In response to the global COVID-19 pandemic, the pharmaceutical company Pharmagenix
developed and distributed a vaccine named VaxMax. The vaccine received Emergency Use
Authorization (from the health regulatory authorities of the Government of Rara) and was
rolled out in a large-scale vaccination campaign. After vaccination, several individuals who
received VaxMax experienced severe adverse effects, ranging from mild allergic reactions to
more severe health complications, including myocarditis, neurological disorders, and in rare
cases, death.

B. AAROGYA TIWARI’S MEDICAL CONDITION – POST VACCINATION

1. On April 10, 2022, Aarogya Tiwari, a 35-year-old woman from Metropolis city of the
State of Rara, eagerly lined up to receive the second dose of VaxMax as per the
mandatory guidelines issued by the State of Rara, hoping to protect herself from the
ravages of COVID-19 pandemic.
2. Soon after receiving the vaccine from the Public Health Clinic, she began experiencing
severe complications. Alarmed by her worsening condition, her family took her to Dr.
Chuckle’s clinic, a private practitioner of the Metropolis City.
3. Medical tests revealed that she suffered a rare adverse reaction of the VaxMax, causing
Thrombosis with Thrombocytopenia Syndrome (TTS).
4. Despite the efforts of medical team of Dr. Chuckle’s Clinic, Aarogya Tiwari succumbed
to her illness and died on April 20, 2022.

C. LAW SUIT FILED BY AAROGYA TIWARI’S FAMILY

5. Family of Aarogya Tiwari, filed a lawsuit against Pharmagenix, and the State of Rara,
claiming that the VaxMax vaccine caused Thrombocytopenia Syndrome in Aarogya
Tiwari, leading to partial paralysis and multiple organs failure, which resulted in her
death.
6. Aarogya Tiwari, received the VaxMax vaccine as per the mandate of the State of Rara, at
Public Health Clinic and experienced symptoms within days of the second dose.

x
MEMORIAL ON BEHALF OF RESPONDENTS
 3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

D. RESPONSE OF PHARMAGENIX IN LIEU TO AAROGYA TIWARI’S CLAIM

7. Pharmagenix, the pharmaceutical company that developed VaxMax, maintains that the
vaccine is safe and effective, citing clinical trials and post marketing surveillance data. It
distributed the vaccine after getting approval from the health authorities of the State of
Rara.
8. The company argues that the benefits of the vaccine in preventing COVID-19 far
outweigh the risks of adverse effects and that they had complied with all regulatory
requirements during the vaccine's development and distribution.

E. MAL PRACTICES AT DR. CHUCKLE’S CLINIC

9. Initial investigation revealed shocking facts about Dr. Chuckle’s Clinic that, it is engaged
in medical malpractices and mishandling some of the emergency cases for making
profits.
10. Many patients came forward to complain against malpractices happening in Dr.
Chuckle’s Clinic, which also raised doubt about treatment given to Aarogya Tiwari.

F. PETITION FILED BY THE PETITIONER AT HIGH COURT OF RARA

In lieu of the above facts, the petitioner has filed a writ petition with High Court of Rara on
Pharmagenix and State of Rara.

The High Court has posted these proceedings for a final hearing on the 28th day of June
2024.

xi
MEMORIAL ON BEHALF OF RESPONDENTS
 3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

STATEMENT OF ISSUES

Counsel on behalf of respondents submits the issues for consideration before the Hon’ble.
High Court of Rara

ISSUE - 1

WHETHER THE PETITIONS ARE MAINTAINABLE OR NOT?

ISSUE - 2

WHETHER PHARMAGENIX BREACHED ANY DUTY OF CARE OR NOT?

ISSUE - 3

WHETHER VAXMAX WAS DEFECTIVELY DESIGNED OR MANUFACTURED, MAKING IT

UNREASONABLY DANGEROUS FOR CONSUMERS OR NOT?

ISSUE - 4

WHETHER THE EMERGENCY USE AUTHORIZATION PROCESS ABSOLVES PHARMAGENIX

LIABILITY

AND SHIFT THE LIABILITY ON THE GOVERNMENT OF RARA FOR FAST-TRACKING VACCINE

APPROVALS OR NOT?

xii
MEMORIAL ON BEHALF OF RESPONDENTS
 3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

SUMMARY OF ARGUMENTS

A. WHETHER THE PETITIONS IS MAINTAINABLE OR NOT?

It is submitted by the counsel appearing on behalf of the respondents that the petition is not
maintainable. This is put forward that this petition should not be entertained as there is
already a serious threat posed by the unprecedented pandemic which had devastating effects
on the entire world called for emergency measures for larger public importance and then
further it is contended that no fundamental rights of the petitioner are violated. Therefore, it is
submitted as the petition is not maintainable
B. WHETHER PHARMAGENIX BREACHED ANY DUTY OF CARE OR NOT?

This was submitted by the counsels appearing on behalf of respondents that Pharmagenix has
not breached any duty of care. Pharmagenix had adequately tested the vaccine for potential
adverse effects undergoing all the phases of clinical trials. Further it is submitted that the
vaccine is distributed after getting approval from health authorities of the state of Rara.
Further, it is submitted that the Fundamental Rights of petitioner is not violated in the present
case.

C. WHETHER VAXMAX WAS DEFECTIVELY DESIGNED OR MANUFACTURED, MAKING IT

UNREASONABLY DANGEROUS FOR CONSUMERS OR NOT?

The counsels appearing on behalf of the respondents submit that Vaxmax was not defectively
designed or manufactured. Secondly, it is submitted that VaxMax is reasonably safe for the
consumers as the benefits of the vaccine in preventing covid-19 far outweigh the risks and
adverse effects. Thirdly, it is contended that VaxMax had complied with all regulatory
requirements during the vaccine’s development and distribution. Therefore, VaxMax is
reasonably safe for the consumers.

D. WHETHER THE EMERGENCY USE AUTHORIZATION PROCESS ABSOLVES PHARMAGENIX

LIABILITY AND SHIFT THE LIABILITY ON THE GOVERNMENT OF RARA FOR FAST-

TRACKING VACCINE APPROVALS OR NOT?

It is submitted that the EUA process doesn’t absolve the Pharmagenix Liability since the
vaccines in use under vaccination program is manufactured by third parties. However, it is
also submitted that the government only encourages all the eligible citizens to consume the
vaccine but doesn’t mandate any one for the vaccination drive. Hence, the Government of

xiii
MEMORIAL ON BEHALF OF RESPONDENTS
 3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

Rara cannot be held liable for issuing EUA to Pharmagenix.

xiv
MEMORIAL ON BEHALF OF RESPONDENTS
 3rd INTRA COLLEGE MOOT COURTCOMPETITION, 2024

ARGUMENTS ADVANCED

I. WHETHER THE PETITIONS ARE MAINTAINABLE OR NOT

¶1. It is humbly submitted before the Hon’ble High court of State of Rara that the current
matter for consideration does not fall under the ambit of the Hon’ble Court since there is no
violation of fundamental right of the petitioner.
¶2. In casu, the Hon’ble Court would not have jurisdiction under Art.226 1 as, the petition is
not maintainable [1.1.] secondly, writ petition should be maintained against a private body
[1.2.]. Finally, Judicial review over decisions of the executive’s public policy [1.3.].
1.1. THE WRIT PETITION BY THE PETITIONER BEFORE THE HC IS NOT MAINTAINABLE
¶3. A writ is essentially an extraordinary jurisdiction of the High Court and must be exercised
only in rare cases to serve the interests of justice 2. This sacrosanct jurisdiction should be
invoked very sparingly. The serious threat posed by the unprecedented pandemic which had
devastating effects on the entire world called for emergency measures for larger public
interest.
¶4. The present writ petition filed by the petitioner is not maintainable because the opinion of
domain experts3 should be taken before the court proceeds further with its judicial review
over the matters of public policy.4

THE PETITIONER HAS ALTERNATIVE REMEDY AVAILABLE AGAINST DR. CHUCKLES

CLINIC FOR THEIR LOSS

¶5. The general rule under Art.32 and 226 is that the person whose right has been infringed has the
right to move to the Courts, as the rights and remedies are correlative to each other. 5 Article 226 also
states that the High court may dismiss the writ petition in case of availability of other alternative
remedy.6 Accordingly in the present case 7 the petitioner may file a medical negligence under torts in
the civil courts for the mal practices of Dr. Chuckle’s Clinic for their loss. But surprisingly in the
present case, the petitioners are requesting this court to issue a writ against the Respondent 1 & 2 and
any kind of such interference with the steps taken by the Union on the basis of the advice given by the
NTAGI8 and other expert bodies would provide impetus to the already prevailing vaccine hesitancy in
certain sections of the society.

1
RARA CONSTI art. 226.
2
(2021) 6 SCC 77.
3
29th Dec 2020, Covid-19 Vaccine (NTAGI), https://www.mohfw.gov.in/ (last Accessed on 28-06-2024).
4
Academy Nutrition Improvement Vs. Union of India, 2 (2011) 8 SCC 274.
5
S P Gupta v. Union of India, AIR 1982 SC 149.
6
Radha Krishna Industries v. State of Himachal Pradesh, 2021 SCC OnLine SC 334.
7
Moot Proposition, ¶9 & 10.
8
29th Dec 2020, Covid-19 Vaccine (NTAGI), https://www.mohfw.gov.in/ (last Accessed on 28-06-2024).
xv
 3rd INTRA COLLEGE MOOT COURTCOMPETITION, 2024

1.2. THE WRIT PETITION AGAINST PUBLIC PARTY IS NOT MAINTAINABLE

¶6. The HC is vested with the power to enforce FRs.9 Dr. Ambedkar described Art.226 as the
very soul of the Constitution.10 It is the duty and privilege of the Courts to uphold the FRs.
But the Writ petition filed by the petitioner is not maintainable; as the petitioners filed it
against the private body for its private actions.

¶7. The maintainability of the petition was questioned given that the respondent 2 is an entity
concerned to be “Private body” and doesn’t fall under the ambit of Article 12. 11 The
Petitioner claims that the petition is maintainable because of the public functions of the
Respondent 2, which is not the case as state only encourages all the eligible citizens to take
vaccination but does not mandate the same. 12 The counsel makes a preliminary objection
regarding the maintainability since the duties and actions of the respondent 2 did not relate to
public functions.

¶8. It’s a well settled principle that writ petition is not maintainable against private limited
company or public limited company in which the State does not have any control unless the
question raised relates to a public function being discharged by such company. 13 In the
present case writ petition is not maintainable since as on the date of filing, Pharamegenix
(India) Limited which is a private entity making vaccination as per the regulatory mandates.
State’s permitting its vaccination doesn’t make a private company perform a public duty.

1.3. JUDICIARY MUST SUPPORT WITH THE EXECUTIVE’S POLICY MAKING DECISIONS

DURING EMERGENCY SITUATIONS

¶10. The state has only issued mandatory guidelines for the vaccination policy 14 but however
as per the operational guidelines issued by the GOI 15 and disseminated to all States/ UTs the
COVID-19 vaccination is totally voluntary; however, all individuals are encouraged to take
vaccination for protecting themselves and their families from serious Covid-19 infection.

¶11. Speaking of those operational guidelines also, the counsel contends that with the current
vaccination policy conforms to all the requirements of Articles 14 and 21 of the

9
M P JAIN, INDIAN CONSTITUTIONAL LAW 1408 (Jasti Chelameswar & Dama Seshadri Naidu ed., LexisNexis, 8 th ed.,
2018).
10
H.M. SEERVAI, CONSTITUTIONAL LAW OF INDIA 1451 (4th ed., Universal Law Publishing Co. Pvt. Ltd., 2005).
11
RARA CONSTI art.12.
12 th
7 August 2021, FAQs on COVID-19 Vaccines and Vaccination Program, MoFHw, https://www.mohfw.gov.in/ (Last
Accessed on 28 June 2024).
13
Asulal Loya vs. Union of India, 2008 SCC OnLine Del 838.
14
Moot Proposition, ¶1.
15
Supra, Note 15.
xvi
 3rd INTRA COLLEGE MOOT COURTCOMPETITION, 2024

Constitution,16 and requires no interference from the courts as the executive should have some
“room for free play in the joints” while dealing with a pandemic of this magnitude.17

¶12. The council also contends that in context of the public health emergency with which the
country has grappled, this Court should appreciate the dynamic nature of the measures that
had been taken by the state. Across the globe, the executive has been given a wider margin in
enacting measures which ordinarily may have violated the liberty of individuals, but now
these measures are need of the hour to curb the pandemic. The council humbly requests the
Hon’ble court to consider the position adopted by the United States Judiciary towards
compulsory vaccination law for battling public health emergencies. 18 Similarly, the State of
Rara has also implemented such policy which only encourages but does not mandate its
citizens.

¶13. It is humbly submitted that separation of powers is a part of the basic structure of the
Constitution. Policy-making continues to be in the sole domain of the executive. The
judiciary is humbly requested to support the executive for its actions as it has access to the
resources which are instrumental to policy formulation during the emergency situations that
the pandemic has posed. Further, it is brought to the notice of this honorable High Court that
the Supreme Court of India had agreed to the vaccination policy of May 31, 2021 through its
judgement19 and under such circumstances the present petition doesn’t hold any merits to
stand.

16
RARA CONSTI art. 12 & 14.
17
DDA vs Joint Action Committee, (2008) 2 SCC 672.
18
Jacobson vs Massachusetts, 197 U.S. 11 (1905).
19
In Re: Distribution of essential supplies and services during pandemic
xvii
 3rd INTRA COLLEGE MOOT COURTCOMPETITION, 2024

ii. WHETHER PHARMAGENIX BREACHED ANY DUTY OF CARE OR NOT?

¶14. It is humbly submitted before the Hon’ble High court of State of Rara that Pharmagenix
has not breached any duty of care. The Pharmagenix had adequately tested the vaccine for
potential adverse effects. Hence, there is no such mandate posed to give any sufficient
warnings about the risks which resulted in death of the petitioner.
¶15. In casu, the Hon’ble Court is requested to consider the following that, Pharmagenix has
taken due care in developing safe and effective vaccination [2.1.]. Further, pharmagenix’s
vaccine might not be the only cause for the death of the petitioner [2.2.].
2.1. PHARMAGENIX HAS TAKEN DUE CARE IN DEVELOPING SAFE AND EFFECTIVE

VACCINATION

¶16. The counsel for the respondent contends that the vaccination for COVID-19 is necessary
to avoid infection.20 The state of Rara was one of the few countries in the world which
succeeded in manufacturing vaccines for protection from COVID-19, one of which was
COVAXIN, Rara’s indigenous vaccine and the other being COVISHIELD, which was
manufactured by Serum Institute of India with technology transfer from AstraZeneca /
Oxford University and the other was Vaxmax which is manufactured by Pharmagenix . The
country started one of the largest inoculation programs in the world in larger public interest.
All the above-mentioned vaccines have received Emergency Use Authorization by WHO 21
and also NTGAI.22
¶17. EUA will be issued only after the particular vaccine has undergone sufficient tests and
parameters laid by the state. In the present situation Pharmagenix, i.e., respondent 2 has
received the EUA approval and necessary clinical trials and all the information is made
available for the public at large through public domains.
¶18. Speaking of the mandates for the EUA issuance, following are the necessary
requirements, the disease for which the product is intended is serious or immediately life
threatening, has the potential of causing an outbreak, epidemic or pandemic and it is
reasonable to consider the product for an EUL assessment, 23 the current Covid-19 Pandemic
is a life threating situation which has already resulted in death of 70,000 plus citizens and
require severe measures24 to curb such a pandemic
20
12 Vaccines Granted Emergency Use Listing (EUL) by WHO, https://covid19.trackvaccines.org/(Last Accessed on 28
June 2024).
21
Id., 24.
22
Supra, Note 8.
23
Emergency Use Listing Procedure, World Health Organisation, https://extranet.who.int/ (Last Accessed on 28th June 2024).
24
October 2, 2021, Merck says it has the first antiviral pill found to Be effective against Covid19, New York Times.
xviii
 3rd INTRA COLLEGE MOOT COURTCOMPETITION, 2024

¶19. The second important mandate for the issuance of EUA is the existing products have not
been successful in eradicating the disease or preventing outbreaks (in the case of vaccines and
medicines);25 in the current situation there are no existing vaccines for the outbreak of the
pandemic.
¶20. The third mandate as per WHO is that the product is manufactured in compliance with
current Good Manufacturing Practices (GMP) in the case of medicines and vaccines and
under a functional Quality Management System (QMS) in the case of IVDs; and in the
present case the respondent undertook the complete the development of the product
(validation and verification of the product in the case of IVDs and applied for WHO
prequalification once the product is licensed it was made fit for the distribution. 26 Hence, the
petitioner claim that the respondent 2 has failed adequately in testing the vaccine doesn’t hold
any merits and clearly such approvals of EUA cannot be issued if there is any kind of
negligence and duty of care.
2.2. PHARMAGENIX’S VACCINE MIGHT NOT BE THE ONLY CAUSE FOR THE DEATH OF THE

PETITIONER

¶21. It is humbly submitted to the Hon’ble High court that consumption of Vax Max might not
be the only cause the petitioner’s death. As the facts 27 suggests that in the initial investigation Dr.
Chuckle’s clinic had engaged in mal practices and mishandling some of the emergency cases for
making profits. Hence, it is contended that the respondent 1 cannot be made liable for the actions
of Dr. Chuckle’s Clinic.
¶22. It is well settled principle that in order to claim medical negligence, the petitioner must
satisfy three conditions as laid down in the Bolam test 28 in order to claim medical negligence.
Firstly, the defendant should owe a duty of care to the plaintiff. In the current situation it is
purely a voluntary act taken by the petitioner to consume VaxMax, the concept of informed
consent or duty of care is not applicable in the current situation as it only voluntary decision of a
drug such as vaccine.
¶23. It is further submitted that the according to Bolam Test the defendant must have breached
this duty of care, but as stated above 29 Respondent 1 vaccine has undergone all the clinical tests
and trials before obtaining EUA.
¶24. Further the plaintiff has suffered an injury due to this breach to claim medical negligence.
Present is the case where there is no breach of duty of care itself. Hence, the three conditions are
25
Supra, Note 27.
26
Moot Proposition ¶Background of the facts.
27
Moot Proposition ¶9 & 10.
28
Bolam v. Friern Hospital Management Committee (1957) 1 WLR 582.
29
Supra to ¶16 & 17
xix
 3rd INTRA COLLEGE MOOT COURTCOMPETITION, 2024

not satisfied to make the respondent 1 liable and accordingly the petition does not hold any
merits.

III. WHETHER VAXMAX WAS DEFECTIVELY DESIGNED OR MANUFACTURED, MAKING IT

UNREASONABLY DANGEROUS FOR CONSUMERS OR NOT

¶25. It is humbly submitted before the Hon’ble High court of State of Rara that Vaxmax was
not defectively designed to make it unreasonably dangerous for the consumers. VaxMax had
adequately been tested through all regulatory practices and clinical tests. 30 Hence, Respondent
1 the developer of VaxMax does not hold any product liability for the loss of the petitioner.
¶26. In casu, the Hon’ble Court is requested to consider the following that, VaxMax is
designed effectively making it reasonable safe for the consumers [3.1.].
3.1. VAXMAX IS DESIGNED EFFECTIVELY MAKING IT REASONABLE SAFE FOR THE

CONSUMERS

¶27. The council for the respondents contended that more than 180 crore doses had been
administered, resulting in a substantial number of individuals in the country being
vaccinated.31 It is humbly submitted that that the vaccines have proved to be effective and
safe and any indulgence by this Court would result in vaccine hesitancy. 32 It is always a
categorical assertion that protection of human life is paramount and its obligatory on behalf
of the states to protect the same.33 Accordingly, the Government had taken extra care to
appoint various committees to examine the efficacy, safety, immunogenicity,
pharmacodynamics of the vaccines before granting approvals.
¶28. The council submits Some of the materials to bolster the Union of India’s submissions
that the has undergone all clinical trials. In Phase III, trials revealed a 77.8% efficacy against
symptomatic COVID-19 disease. The findings of the clinical trials have been published in
reputed peer-reviewed journals and are readily available on the website of MoFHw.34
¶29. It was further contended that Respondent No.1 is in compliance with the WHO
Statement on Clinical Trials as the key outcomes and results of the Phase III clinical trial
have been published in the Lancet. 35 On behalf of Respondent No. 1, it was submitted that the
clinical data generated during the trials had been submitted to the regulatory authorities for
obtaining permissions / licenses etc. Further, the peer-reviewed study of the partial clinical
30
Moot Proposition ¶7 & 8.
31
Cowin portal on Vaccination Drive, https://www.mohfw.gov.in/ (Last Accessed on 28 June 2024).
32
Supra Note, ¶13.
33
Common cause (A Regd. Society) V. Union of India, 22 (2018) 5 scc1.
34
Covid-19 Vaccine Trails, https://cdsco.gov.in/ (Last Accessed on 28 June 2024).
35
Clinical Trails, The lancet Publication, https://www.thelancet.com/ (Last Accessed on 28 th June 2024).
xx
 3rd INTRA COLLEGE MOOT COURTCOMPETITION, 2024

data of Phase II / III trials had already been published in reputed scientific journals, which
included all the information necessary for safeguarding the public as well as informing them
of the credibility and efficacy of the vaccine.
¶31. As per the consumer Protection Law, in order to file a case for product liability the
following conditions must be satisfied. Firstly, the products supplied must be defective; in the
current situation there are enough medical data which proves that 77.8% success rate is
acquired by the vaccine, which itself means that there is no kind of defectiveness in the
product
¶32. It is further contended that under CPL the consumer should be charged excessively for
the product in order claim product liability, in the current situation the State of Rara had
provided free medical vaccination drive which states that there is no excess rate charged by the
respondent
¶33. Further it is contended that in order to claim product liability there should products which
are hazardous to life and safety are being offered by a trader who is aware of the unsafe nature
of the products and offers products in contravention of prescribed standards; and in the current
scenario the trader is providing safe and successful vaccines as per who and NTGAI
mandatory guidelines making the vaccine safe and sound for its consumers.
¶34. Further there should be some unfair or restrictive trade practices are adopted by the
trader, which in the current case is never done, since the state of Rara always made the
vaccination and its related data available to public at any point of time through COWIN
portals. Hence, the VaxMax does not absolve any product liability.

IV. WHETHER THE EMERGENCY USE AUTHORIZATION PROCESS ABSOLVES PHARMAGENIX

LIABILITY AND SHIFT THE LIABILITY ON THE GOVERNMENT OF RARA FOR FAST-TRACKING

VACCINE APPROVALS OR NOT?

¶35. It is humbly submitted before the Hon’ble High court of State of Rara, that the EUA process
absolves the Pharmagenix Liability and the liability does not shift to the Government of Rara for its
fast-tracking of vaccine approvals as such immediate responses are need of the hour
¶36. In casu, the Hon’ble Court is requested to consider the following that, EUA Process is safe
and up to the mark [4.1.] and also, Government of Rara is not liable for its fast-tracking of
vaccine approvals as such immediate responses are need of the hour [4.2].
4.1. EUA PROCESS IS SAFE AND UP TO THE MARK
¶37. Clinical trials are evaluating investigational COVID-19 vaccines in tens of thousands of
study participants to generate the scientific data and other information needed by FDA to
xxi
 3rd INTRA COLLEGE MOOT COURTCOMPETITION, 2024

determine safety and effectiveness. These clinical trials are being conducted according to the
rigorous standards set forth by the NTGAI.

¶38. It is humbly submitted that EUA is a regulatory mechanism to allow the use of vaccines
and medicines to prevent and/or reduce the impact of life-threatening diseases or conditions
as caused by COVID-19. However, before grant of the EUA, there are rigorous assessments
of laboratory and clinical trial data, including data on quality, safety, production of protective
antibodies and efficacy. Safety is particularly critical aspect of this scrutiny and a risk-versus-
benefit evaluation is done in the context of a public health emergency. Full licensure is
obtained when the manufacturer submits the complete data. EUA by Indian regulators is
aligned with global guidelines. 36
¶38. It is further contended that the CONCEPT of EUA always existed to save the lives of
people all over the world with vaccine and medicines for life threatening diseases while
companies continue to obtain additional safety and effectiveness information to enable full
licensure. Previously, EUAs have been granted to vaccines for outbreaks due to Anthrax,
Ebola, Enterovirus, H7N9 influenza, and Middle East Respiratory Syndrome. In the present
situation also, such procedure is adopted by the state as per the WHO mandates. 37 Hence, the
respondent contends that the EUA procedure which is accepted world wide for ages is
efficient enough to understand the drawbacks before approving the vaccines.
¶39. Further, the state of Rara within the competence of the State in exercise of its powers
under DM Act38 and the Public Health Act, 1939. Section 76(2)(b) which empowers the State
Government to make vaccinations compulsory.

4.2. GOVERNMENT OF RARA NOT LIABLE FOR ITS FAST-TRACKING OF VACCINE

APPROVALS AS SUCH IMMEDIATE RESPONSES ARE NEED OF THE HOUR

¶40. Under DM Act, the state has the responsibility to safeguard its citizens during
emergency situations and in the current case, the state had not even fast-tracked any vaccine
approvals without clinical trials. All vaccines have conducted their phase I, II & III clinical
trials before EUA and only after these clinical trials, they have been granted EUA by

36
Supra, Note12.
37
Supra, Note 23.
38
The Disaster Management Act, 2005
xxii
 3rd INTRA COLLEGE MOOT COURTCOMPETITION, 2024

CDSCO39 All the vaccinations approved by the state had been undergone all the necessary
measures and clinical trials. Hence, it is contended that fast-track approval has not even even
been given to make the state liable as per the MofwH40

39
Supra, Note 12.
40
Supra, Note 12.
xxiii
 3rd INTRA COLLEGE MOOT COURTCOMPETITION, 2024

PRAYER

Wherefore, in the lights of facts stated, issues raised, authorities cited & written
pleadings, it is most humbly prayed & implored before the Hon’ble High Court, that it
may be graciously pleased to -

1. Dismiss the writ petitions filed by the petitioners.

2. Not to direct the Respondent 1 liable for negligence or defective manufacturing under any
section of law as they have followed all the guidelines issued by NTGAI & WHO. Any
such kind of unreasonable restrictions and will lead to destruction of the Policy
measures taken by the Respondent 2 for larger Public Interest in wake of the
pandemic.
3. In the alternative declare -
a) That the respondents have not violated any of the Fundamental Rights granted
to the petitioners by the Constitution of Rara.
b) That the Respondent 1 & 2 are not liable for the petitioner cause of death.

AND/OR

Pass any other Order, Direction, or Relief that may deem fit in the Best Interests of
Justice, Fairness, Equity, and Good Conscience which this Hon’ble Supreme Court
may feel proper in the circumstances of the case.

And for this act of kindness, the respondent’s duty bound shall forever pray.

All of which are most humbly prayed.

S/d-

Counsel for the Respondents

Team #09

24
3rd INTRA COLLEGE MOOT COURTCOMPETITION, 2024

25
3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

MEMORIAL ON BEHALF OF RESPONDENTS

3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

MEMORIAL ON BEHALF OF RESPONDENTS

3rd INTRA COLLEGE MOOT COURT COMPETITION, 2024

MEMORIAL ON BEHALF OF RESPONDENTS