IN THE SUPREME COURT OF INDIA

CIVIL ORIGINAL JURISDICTION

WRIT PETITION (CIVIL) NO. OF 2020

[ PUBLIC INTEREST LITIGATION ]

Extremely Urgent for COVID-19 Pandemic

IN THE MATTER OF

People for Better Treatment (PBT)

through its President, Dr. Kunal Saha … Petitioner

Versus

Secretary, Ministry of Health &

Family Welfare & Anr. ….Respondents

PAPER BOOK

(FOR INDEX KINDLY SEE INSIDE)

Petitioner-in-person
 INDEX

Sl. No. Particulars Page Nos.

1. Synopsis/List of Dates p. 5 - 23

2. Writ Petition with Affidavit p. 24 – 67

a) Facts: p. 32-50; b) Law questions: p. 50-53;
c) Grounds: p. 53-59; Prayers: p. 61-64

3. ANNEXURE A-1 (18 pages)

A copy of latest directions issued and

uploaded on the website by Respondent no. 1

for management and treatment of COVID-19

patients dated 31st March, 2020 as

“Revised Guidelines on Clinical

Management of COVID-19”.

4. ANNEXURE A-2 (1 page)

A copy of Article titled “Caution recommended

on COVID-19 treatment with hydroxychloroquine

2
 and azithromycin for patients with cardiovascular

disease published on April 08, 2020 by

American Heart Association (AHA) and

available at https://newsroom.heart.org/news

5. ANNEXURE A-3 (4 pages)

A copy of Article titled “Safety

considerations with chloroquine,

hydroxychloroquine and azithromycin in

the management of SARS-CoV-2

infection” by David N. Juurlink MD PhD

[Cite as: CMAJ 2020. doi: 10.1503/cmaj.200528;

early-released April 8, 2020]

6. ANNEXURE A-4 (1 page)

A copy of Article titled “Safety of

hydroxychloroquine, alone and in

combination with azithromycin, in light of

rapid wide-spread use for COVID-19:

3
 a multinational, network cohort and

self-controlled case series study” posted on

April 10, 2020 by Jennifer C.E Lane et al

available at

https://doi.org/10.1101/2020.04.08.2005455

7. ANNEXURE A-5 (2 pages)

A copy of Written representation dated

08.4.2020 submitted by the Petitioner NGO

to the Respondent No.1.

8. Affidavit of undertaking p. 68-71 (4 pages)

9. Application to Argue “In-person” p. 72-75 (4 pages)

10. Application for Urgency p. 76-78 (3 pages)

11. Memo of Appearance p. 79 (1 page)

** In parenthesis (-), are uploaded separately

4
 SYNOPSIS AND LIST OF DATES

The unprecedented COVID-19 (coronavirus disease, 2019)

pandemic, caused by a novel SARS-CoV-2 virus, was first identified

in December, 2019 in Wuhan, China. Over the past 3-4 months,

COVID-19 pandemic has already ravaged India and across the

globe. Like most other countries, regular life in India has virtually

come to an abrupt and indefinite halt with the rapid spread of fear

for COVID-19. Indian government has taken many difficult but

necessary steps to curb the menace of COVID-19, e.g. social

distancing, lockdown and quarantine measures. Despite these

preventive measures by government, large number of people across

India have already contracted the disease and died due to COVID-

19 as the deadly coronaviruses have still continued to spread.

Naturally, the Ministry of Health (Respondent no. 1) has

assumed the most critical role to combat the ongoing COVID-19

pandemic. Isolation wards in hospitals and health centers across

India have been revamped to tackle the highly contagious SARS-

5
CoV-2 viruses and curb the spread of COVID-19 with strict

guidelines issued by Respondent no. 1. Most importantly, specific

guidelines for clinical management of COVID-19 are published and

updated by Respondent no. 1 for all Indian doctors and healthcare

workers to follow for treatment of COVID-19 patients. The latest

directions issued by Respondent no. 1 for management and treatment

of COVID-19 patients was issued dated 31st March, 2020 and

uploaded on the website of Respondent no. 1 as “Revised Guidelines

on Clinical Management of COVID-19”, which is annexed herewith

and marked as Annexure- A1.

It is no surprise that most of the drugs presently being used to

treat COVID-19 patients are based primarily on anecdotal evidence

and not on direct scientific data because very little actual research

has been published on this new strain of coronaviruses which was

isolated for the first time only a few months ago. COVID-19

patients receive primarily symptomatic therapy because no specific

drug against the new SARS-CoV-2 viruses has been invented till

now. In fact, in the “Revised Guidelines on Clinical Management

6
of COVID-19”, Respondent no. 1 has candidly and rightly admitted

that no specific antiviral therapy against COVID-19 exists “as per

currently available data” (Annexure- A1, p. 18). Needless to say

that when treating the vulnerable patients with a new and unproven

drug for its “off-label” use, doctors should be extra vigilant about its

potential harmful adverse effects on COVID-19 patients.

The present treatment guidelines by Respondent no. 1 have

recommended to use an old anti-malarial drug, Hydroxychloroquine

(hereinafter referred as “HCQ”) and a well-known broad-spectrum

antibiotic, Azithromycin (hereinafter referred as “AZM”) in the most

critically ill COVID-19 patients who are in ICU (Annexure- A1, p.

18, Section 10 “Specific Therapy”). The off-label use of HCQ and

AZM in COVID-19 patients has already created a great deal of

controversy among healthcare professionals because of their

previously known potentially life-threatening side effects,

particularly on the cardiovascular system.

7
 In fact, the American Heart Association (AHA), American

College of Cardiology (ACC) and Heart Rhythm Society (HRS) in

USA issued an extraordinary joint bulletin on 8th April, 2020 with

stark warnings for doctors before and during the use of HCQ and

AZM in COVID-19, especially for patients with existing cardiac

conditions since these drugs have potential to trigger arrythmia

(abnormal heartbeat), heart failure and even death (Annexure- A2).

The AHA/ACC/HRS joint bulletin has further advised to follow

specific therapeutic measures for preventing fatal outcome in

COVID-patients treated with HCQ and AZM. These precautionary

guidelines issued by AHA/ACC/HRS are obviously aimed toward

reducing the serious and potentially lethal risks involved with the

“off-label” use of HCQ and AZM (Annexure- A2). The

AHA/ACC/HRS joint bulletin has issued strong warnings for

doctors who plan to treat COVID-19 patients with combination of

HCQ and AZM in view of these drugs’ known side effects on the

cardiovascular system. The cautionary guidelines by

AHA/ACC/HRS also recommended following six specific

therapeutic measures that doctors should adopt to prevent

8
catastrophic medical outcome when treating acutely ill COVID-19

patients with HCQ and AZM:

i) Electrocardiographic (ECG) QT monitoring.

ii) Withhold HCQ and AZM in patients with baseline QT (e.g. >

500 msec) or with known congenital long QT syndrome.

iii) Monitor QT rhythm and QT interval; withdrawal of HCQ and

AZM if QTc exceeds a present threshold of 500 msec.

iv) In patients critically ill with COVID-19 infection, frequent

caregiver contact may need to be minimized, so optimal

electrocardiographic interval and rhythm monitoring may not

be possible.

v) Correction of hypokalemia >4mEq/L and hypomagnesemia

>2 mg/dL.

vi) Avoid other QTc prolonging agents whenever feasible.

In the updated treatment guidelines issued on 31st March,

2020 for doctors and hospitals across India, Respondent no. 1 has

made categorical recommendation to use HCQ and AZM

combination drug therapy for the critically ill ICU patients afflicted

9
with COVID-19 without any direct scientific evidence (Annexure-

A1). It is truly alarming that while Respondent no. 1 has advised

“off-label” treatment with HCQ and AZM mostly on anecdotal

evidence for serious COVID-19 patients, they have failed to provide

the important and specific precautionary measures that doctors

should take before and during the use of these drugs apart from

vaguely stating that “these drugs should be administered under close

medical supervision with monitoring of side effects including QTc

intervals” (Annexure- A1, p. 18). Most of the six specific

preventive and/or corrective precautionary measures as advised by

AHA/ACC/HRS to prevent potentially lethal consequences as a

result of HCQ and AZM treatment cannot be found in the treatment

guidelines recommended by Respondent no. 1 in Annexure- A1.

A second study issued almost identical warnings as provided

by the AHA/ACC/HRS, was recently published in the Canadian

Medical Association Journal (CMAJ) for using HCQ and AZM in

COVID-19 patients. This review article also recommended that

extreme precaution should be taken by doctors before using HCQ

10
and AZM in COVID-19 patients because of the serious side effects

of these two drugs. The study summarizes the salient points in the

“Conclusion” which is reproduced hereinbelow (Annexure- A3):

“The use of either chloroquine or hydroxychloroquine

and azithromycin for treatment or prevention of SARS-

CoV-2 infection is currently supported primarily by in

vitro data and weak studies involving humans.

Physicians and patients should be aware of several

uncommon but potentially life-threatening adverse

effects should these drugs be used before better-

designed studies determine their benefit, if any, in

treating or preventing COVID-19. Harms of treatment

can be mitigated by careful patient selection and

monitoring.” (emphasis added)

Another massive multi-national (USA, UK, Germany, Spain,

Japan, Netherlands) study entitled “Safety of hydroxychloroquine,

alone and in combination with azithromycin, in light of rapid wide-

spread use for COVID-19: a multinational, network cohort and self-

11
controlled case series study” with direct analysis of more than

300,000 patients’ data just published online underscoring the

potential but serious dangers and urgent need to take precautionary

measures for any “off-label” use of HCQ and AZM in COVID-19

patients. This major international study found that although no

excessive risk for severe adverse events (SAE) was associated with

short-term use of Hydroxychloroquine (HCQ) alone, but increased

risks of 30-day cardiovascular mortality, chest pain/angina and heart

failure were observed when both HCQ and AZM were used together

(Annexure- A4).

The real and potentially life-threatening risks, as observed by

leading medical groups/experts around the globe (Annexures-

A2/3/4) for anecdotal and unproven treatment of serious COVID-19

patients with “off-label” use of a combination of HCQ and AZM,

demands that Respondent no. 1 must immediately take steps to bring

necessary precautionary measures in the treatment guidelines

described in Annexure- A1 to save lives of the ICU COVID-19

patients. Even if Indian medical authority decides to continue with

12
the “off-label” use of HCQ/AZM on critically ill COVID-19 patients

despite the serious warnings issued by the international medical

community (Annexures- A2/3/4), in the minimum, Respondent no.

1 must inform all healthcare workers involved with COVID-19

patients to adopt immediately the 6 specific preventive and

precautionary therapeutic measures as advised by AHA/ACC/HRS

to mitigate the adverse effects and possible death of the COVID-19

patients receiving HCQ and AZM therapy.

That the Petitioner-organization submitted an urgent written

representation to Respondent no. 1 soon after the joint bulletin was

released by the AHA/ACC/HRS on 8th April, 2020 intimating the

Health Ministry about the serious and potentially life-threatening

dangers for using HCQ and AZM in COVID-19 patients and urging

Respondent no. 1 to immediately adopt the precautionary measures

as advised by AHA/ACC/HRS and other international medical

organizations (Annexure- A5). Unfortunately, even after several

reminders by your Petitioner via telephone/email considering the

extremely urgent situation, Respondent no. 1 has remained

13
absolutely silent and did not respond or shown any interest to adopt

any precautionary measures to mitigate the obvious risks including

heart failure and death involved with the acutely sick ICU patients

with COVID-19 receiving treatment with HCQ and AZM as advised

in Annexure- A1 by the Ministry of Health for doctors and

healthcare workers across India.

Hence, is the instant PIL.

LIST OF DATES

Jan. 30, 2020: First COVID-19 case reported in India. A

national pandemic of COVID-19 has still continued to

ravage the entire country with thousands of patients

already infected with the coronaviruses (SARS-CoV-2)

and hospitals across India are filling with numerous

critically ill COVID-19 patients who may require

treatment in ICU.

14
March 31, 2020: Ministry of Health & Family Welfare

(Respondent no. 1), in consultation with Indian Council

of Medical Research (ICMR), published a “Revised

Guidelines on Clinical Management of COVID-19” on

their website with detail protocols for treatment of

COVID-19 patients at various stages of the disease

(Annexure- A1). The treatment guidelines by

Respondent no. 1 specifically recommends that

although no specific antiviral drugs are available

against COVID-19, patients afflicted with

coronaviruses who have developed “severe disease and

requiring ICU management” may be treated with

HCQ and AZM. It may be pertinent to mention that the

Ministry of Health has printed “in patients with severe

disease and requiring ICU management” portion of the

guidelines in bold letters underscoring that it may be

important for ICU patients with COVID-19 to receive

“off-label” treatment with HCQ and AZM. In regard to

any warnings or precautions for the well-known

15
adverse effects of these drugs, the treatment guidelines

recommended by Respondent no. 1 have merely stated

that it should be done “under close medical supervision

with monitoring for side effects including QTc

intervals” and that this dual-drug treatment is not

recommended for “children less than 12 years,

pregnant and lactating women”.

As discussed above, HCQ and AZM are known

to have a wide range of side effects including serious

and potentially lethal cardiac complications. Although

the treatment guidelines with HCQ and AZM by

Respondent no. 1 have specifically excluded children

and pregnant or lactating women, there is no warning

to exclude other group of patients with known cardiac

ailments, e.g. “congenital long QT syndrome”. There

is also no precaution recommended to monitor

development of hypokalemia (low serum potassium) or

hypomagnesemia (low serum magnesium) in patients

receiving HCQ and AZM that may be life-threatening

16
 as specifically suggested by AHA/ACC/HRS

(Annexure- A2).

April 8, 2020: An urgent news bulletin was published jointly by

AHA/ACC/HRS with serious cautionary notes and

guidance for treatment of COVID-19 patients with

HCQ and AZM (Annexure- A2). Under the present

unprecedented situation and expanding global COVID-

19 pandemic, the leading cardiac experts in

AHA/ACC/HRS felt it necessary to issue an

extraordinary joint bulletin to warn the healthcare

professionals about the potential but serious dangers for

using the combination drug therapy with HCQ and

AZM in COVID-19 patients. The joint report by

AHA/ACC/HRS which was also published in three

leading international cardiac journals, Journal of

American College of Cardiology, Circulation and

Heart Rhythm Journal, also provided specific

therapeutic guidance for doctors to follow if they

17
decide to use the combination therapy with HCQ and

AZM in COVID-19 patients. These life-saving

therapeutic precautions include close heart and

electrolytes monitoring and immediate withdrawal of

these drugs with development of specific ECG and

electrolytes changes in order to avoid the dangerous

and potentially lethal cardiac catastrophes leading to

heart failure and possible death of patients (Annexure-

A2).

The Canadian Medical Association Journal

(CMAJ) also published a review article around the

same time that echoed similar warnings issued by

AHA/ACC/HRS, in which the serious concerns for

treating COVID-19 patients with HCQ and AZM were

raised with specific advise that doctors using these

drugs in COVID-19 patients must be extremely

cautious about the potential dangers and that they must

be very careful in selecting COVID-19 patients for such

18
 therapy for potential of developing cardiac

complications and death (Annexure- A3).

April 8, 2020: The Petitioner-organization (PBT), a registered

NGO dedicated for promotion of a better healthcare

delivery system in India for the past more than two

decades, was alarmed with the increasing menace of the

COVID-19 epidemic and treatment in India. Dr. Kunal

Saha, originally a physician from India and founding-

president of PBT, who is also a well-known virologist

involved with the study of HIV/AIDS for the past more

than 25 years in USA, was deeply concerned with the

widespread use of HCQ and AZM in India on seriously

ill ICU patients with COVID-19 following the

treatment guidelines issued by Respondent no. 1

(Annexure- A1). The combination HCQ and AZM

therapy for COVID-19 patients is likely to pose the

most serious threat for patients with pre-existing heart

conditions as clearly stated by the American

19
(Annexure- A2) as well as the Canadian (Annexure-

A3) studies. It is also becoming increasingly clear that

the elderly patients with COVID-19 are more prone to

develop serious diseases and likely to be treated in ICU

with HCQ and AZM as advised by Respondent no. 1.

It is also a common knowledge today that elderly

citizens are also more likely to have cardiac conditions

e.g. abnormal heartbeat (arrythmia), ischemia,

atherosclerosis (blocked blood vessels) or high blood

pressure etc. Thus, it is of great concern that more

COVID-19 patients treated in ICU are likely to develop

serious adverse effects as a result of treatment with

HCQ and AZM as unequivocally recommended by the

Indian Health Ministry in Annexure- A1. In order to

avoid such needless medical calamities, Petitioner

submitted an urgent representation with Respondent

no. 1 requesting them to consider the important and

specific recent studies and recommendations made by

AHA/ACC/HRS (Annexure- A2) and Canadian

20
 medical association (Annexure- A3) and to implement

these important precautionary therapeutic measures in

the treatment guidelines for COVID-19 patients.

Moreover, in view of the massive multi-nation

international study with more than 300,000 patients’

data showing the increased risk for mortality and heart

failure in COVID-19 patients treated with HCQ and

AZM (Annexure- A4), it was also imperative for

Respondent no. 1 to make doctors and other healthcare

workers in India aware about the potential dangers of

these drugs and to obtain valid “informed consent” as

per law from the COVID-19 patients and their families

before putting them to the unproven treatment with

HCQ and AZM.

April 8-10, 2020: Petitioner submitted a formal

representation with Respondent no. 1 with an urgent

appeal to take appropriate preventive measures to save

the lives of COVID-19 patients in ICU who were being

21
 treated with HCQ and AZM as recommended in the

joint public bulletin from AHA/ACC/HRS in USA as

well as CMAJ (Annexure- A5). As Respondent no. 1

remained silent and considering the extremely urgent

nature of the present situation, Dr. Saha, president of

Petitioner-organization, also made a direct telephone

call and talked with the office of Respondent no. 1

expressing serious concerns and wanted to know what

action, if any, was taken by Respondent no. 1 in view

of their formal representation vide his letter April 8,

2020 (Annexure- A5). Although Dr. Saha was told

over phone that his request would be looked into

shortly but no response, written or telephonic, was

received and no precautionary action was taken till now

by Respondent no. 1.

April 13, 2020: Hence this urgent public interest litigation (PIL)

seeking urgent directions to Respondent no. 1 to make

immediate changes in the published guidelines for

22
treatment of ICU-bound COVID-19 patients who were

receiving HCQ and AZM and also to obtain appropriate

“informed consent” from the COVID-19 patients

and/or their families who are chosen to be treated with

HCQ and AZM in view of potential serious adverse

effects and increased risk of heart failure and death

from these two medicines used “off-label” as

specifically warned by international medical

organizations (Annexure- P-2 / 3 / 4 /6).

23
 IN THE SUPREME COURT OF INDIA

CIVIL ORIGINAL JURISDICTION

WRIT PETITION (CIVIL) NO. OF 2020

[ PUBLIC INTEREST LITIGATION ]

Extremely Urgent for COVID-19 Pandemic

IN THE MATTER OF:

People for Better Treatment (PBT)

through its President Dr. Kunal Saha,
having its head office at:
Commercial Point (Ground Floor)
79 Lenin Sarani, Kolkata – 700013
Also at
6725 Longshore Street, Suite 507
Dublin, Ohio 43017, USA
Telephone : 001-614-893-6772/9831983670
Email: ANKU@AOL.COM … Petitioner

Versus

1. Union of India
through its Secretary,
Ministry of Health & Family Welfare
Nirman Bhawan, New Delhi 110011 …. Respondent No. 1

24
2. Indian Council of Medical Research (ICMR)
through its Direct General
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar,
New Delhi – 110029 …Respondent No. 2

WRIT PETITION IN PUBLIC INTEREST UNDER

ARTICLE 32 OF THE CONSTITUTION OF INDIA

SEEKING URGENT DIRECTION TO RESPONDENT NO.

1 FOR MAKING IMMEDIATE CHANGES IN THE

TREATMENT GUIDELINES FOR SERIOUSLY ILL

COVID-19 PATIENTS IN ICU AND FOR OBTAINING

“INFORMED CONSENT” FROM PATIENTS WHO ARE

BEING TREATED WITH AN ANECDOTAL AND

UNPROVEN COMBINATION OF ANTI-MALARIAL

“HYDROXYCHLOROQUINE” (HCQ) AND BROAD-

SPECTRUM ANTIBIOTIC “AZITHROMYCIN” (AZM)

BY TAKING PRECAUTIONARY THERAPEUTIC

MEASURES AS RECOMMENDED ON 8TH APRIL, 2020

BY AMERICAN HEART ASSOCIATION (AHA),

25
 AMERICAN COLLEGE OF CARDIOLOGY (ACC) AND

HEART RHYTHM SOCIETY (HRS) (ANNEXURE- A2)

AS WELL AS BY CANADIAN MEDICAL ASSOCIATION

(ANNEXURE- A3) AND BY A MULTI-NATIONAL

STUDY WITH MORE THAN 300,000 PATIENTS

(ANNEXURE- A4) FOR PREVENTING POTENTIALLY

DEADLY SIDE EFFECTS OF THESE MEDICINES IN

ACCORDANCE TO THE “URGENT

REPRESENTATION” DATED 8TH APRIL, 2020 SENT BY

THE PETITIONER (ANNEXURE- A5) TO PREVENT

LOSS OF LIVES OF COVID-19 PATIENTS AND ALSO

FOR ISSUANCE OF WRIT, ORDER, DIRECTION OR

ANY OTHER APPROPRIATE DIRECTIONS.

To,

The Hon’ble Chief Justice of India and

His Companion Judges of the

Hon’ble Supreme Court of India.

26
The humble Writ Petition (PIL)

of the Petitioner above-named.

27
Most Respectfully Showeth:

1. The present petition under Article 32 of the

Constitution of India is being filed by way of public

interest litigation (PIL) and the Petitioner has no

personal interest except for protecting lives of

innocent patients in ICU afflicted with the COVID-

19 and who are being treated with an unproven

and “off-label” use of anti-malarial drug, HCQ and

broad-spectrum antibiotic, AZM combination that

has shown serious and potentially lethal side

effects as recently reported in several scientific

studies by the leading international medical

groups (Annexures- A2/3/4). The Petitioner-

organization is a registered (Registration no.

S/IL/6017 under West Bengal Registration of

Societies Act, 1961) humanitarian society with its

head office in Kolkata that has been working

relentlessly for promotion of better healthcare and

28
helping ordinary patients and victims of medical

negligence in India since its inception in 2000-

2001. Over the past two decades, the Petitioner

has fought many major public interest litigations

(PILs) before this Hon’ble Court and various High

Courts against the flaws in the medical education

and healthcare delivery system with an aim to

elevate the standard of healthcare and to prevent

“medical negligence” in India. The legal battles by

your Petitioner include a historic PIL (SC W.P. Civil

No. 317/2000) that led to the shocking discovery

in 2002 that many States and Union Territories in

India had absolutely no functioning “medical

council” for regulation of practice of medicine more

than 50 years after the independence. The said

PIL eventually paved the way not only for

establishment of “medical council” in every State

and Union Territory across India, it also helped to

correct several inherent flaws in the medical

29
regulatory system at MCI including introduction of

the Sections 8.7 and 8.8 in the MCI “Code of Ethics

and Regulations” for proper and timely disposal of

complaints against the delinquent physicians

(2003 SCC 8, 490). In another more recent PIL

filed by your Petitioner (W.P. Civil No. 253/2012;

People for Better Treatment vs. Indian Medical

Association & Ors.), this Hon’ble Court has taken

a commendable step to prevent “doctors’ strike”

that has brought endless pain, suffering and death

of the innocent patients.

1A. That the Petitioner NGO (PBT) is represented through

its founding President Dr. Kunal Saha who is a medical doctor

himself, once an Indian Citizen, now permanently settled in

USA (OCI Card Holder No. A 130853). That said Dr. Kunal

Saha is duly authorized by PBT to file, argue and take

necessary actions in the instant PIL. Dr. Saha has the

following contact details: Email: anku@aol.com;

30
Telephone/WhatsApp contact: 001-614-893-6772 (USA);

9831983670 (India). Annual income of Petitioner-

organization from all sources is about Rs. …………..../- only,

and PAN card no. is AABTP9280G. The Petitioner has

immense interests in social development and being a social

activist for the past more than two decades to bring positive

changes in the Indian healthcare and medical education

systems. The Petitioner has absolutely no personal interests,

whatsoever, in the present matter and is not involved in any

civil, criminal and/or revenue litigation which has or could

have a legal nexus with the issues involved in the instant PIL.

That issues involved in the present writ petition is of

extremely urgent in nature because it has a direct nexus with

the treatment of the innocent COVID-19 patients in India that

may be posing potential dangers to them and seeking to

implement appropriate precautionary therapeutic measures to

protect the lives of these patients. Hence, the prayers have

thus been sought by the Petitioner in the present petition. The

Petitioner already approached the concerned government

31
 authority by way of submitting Written Representation

(Annexure P-5) as regards the issues herein. That no

reply/response to that effect has been received so far. The

Petitioner categorically states that there is no personal gain,

private motive or any oblique reason in filing the present

Public Interest Litigation. The Petitioner through its President

has locus standi to seek the reliefs sought for in the instant

Writ Petition.

2. Facts of the case

i. It is most respectfully submitted that it would be no

exaggeration to say that India and rest of the world have been

under seize for the past 3-4 months from an unprecedented

attack by a novel coronavirus (SARS-CoV-2), the causative

agent for the present pandemic of COVID-19. In order to

combat this extraordinary situation, Indian government has

already adopted important social and official changes

including long-standing “lockdown” of the entire nation.

32
Needless to say that the Health Ministry (Respondent no. 1)

perhaps bears the highest responsibility in this battle against

the ongoing COVID-19 pandemic. In order to control the

spread of COVID-19 and to provide protocols for proper and

uniform treatment against this novel coronavirus pandemic,

Respondent no. 1, with aid from other agencies like ICMR,

has been playing the key role through guidance and regular

scientific notifications on their website and through the media

at large. Needless to say that doctors in hospitals and clinics

across India are largely dependent on the notifications and

scientific guidelines provided by Respondent no. 1 for

diagnosis and clinical management of COVID-19 patients.

ii. That perhaps the most vital document in this regard

produced by Respondent no. 1 for Indian doctors and

hospitals during this unprecedented medical crisis is the

recommendations and guidelines as how to diagnose, control

and treat COVID-19 patients. This is particularly important

33
because of the undeniable fact that there is very little medical

research done on COVID-19 till now because it is a novel

virus first isolated in China only 4-5 months ago. There is

also no specific anti-viral drugs available against COVID-19.

So, doctors and healthcare workers across India always look

toward the central health ministry for proper guidance and

management of COVID-19 patients. The Ministry of Health

& Family Welfare, (Respondent no. 1) published a

comprehensive “Revised Guidelines on Clinical Management

of COVID-19” on their website on 31st March, 2020 that

included detail description of how to test, diagnose and most

importantly, treat COVID-19 patients (Annexure- P-1).

iii. That in this formal directives for proper clinical

management and treatment of COVID-19 patients,

Respondent no. 1 has specifically advised (under section 10

“Specific Therapy”) that although no specific anti-viral

medicines are available against COVID-19, a combination of

HCQ (anti-malarial drug) and AZM (antibiotic) may be

34
administered as an “off-label” use to the most seriously ill

COVID-19 patients who are in ICU (Annexure- A1, p. 18).

Needless to say that many doctors have started using HCQ

and AZM to treat their most critically ill COVID-19 ICU

patients in hospitals across India following the published

treatment guidelines put forward by Respondent no. 1. As

discussed earlier, the “off-label” use of an anti-malarial

(HCQ) and broad-spectrum antibiotic (AZM) were

recommended for the most serious COVID-19 patients by

Respondent no. 1 based primarily on anecdotal evidence and

not as a specific therapy against COVID-19 as candidly

admitted under the same guidelines (Annexure P-1, p. 18).

iv. The Petitioner most humbly submits that from the

ancient days of Hippocratic Oath to the day of modern

medicine now, it is well accepted that members of the noble

profession of medicine can only try to cure and save a patient

when he can but a doctor should always remember that above

all, he must do no harm to the patient. Unfortunately, almost

35
all allopathic drugs are chemical in nature that frequently

exhibit adverse or harmful side effects. A doctor must be

aware about the unwanted side effects of every medicine he

plans to use on his patient and he must be prepared to take

appropriate remedial measures if any harmful or adverse

effects develop in a patient. The avoidable injury or death of

a patient as a result of adverse effects by reckless use of a drug

without anticipating or taking any precautionary measure is

the worst form of medical negligence, as held many times by

this Hon’ble Court. Although it may sometime be necessary

for a doctor to use a drug “off-label” (use of a drug for which

it has not been originally approved) under a dire situation in

order to save the life of a patient, doctors must always be extra

vigilant for any untoward or side effects for “off-label” drug

use on patients.

v. That “off-label” use of HCQ and AZM in acutely ill

COVID-19 patients, as recommended by Respondent no. 1,

has been highly controversial from the very beginning for

36
obvious reasons. However, both HCQ (anti-malarial) and

AZM (antibiotic) were studied extensively prior to FDA

approval for their use in indicated medical conditions and both

drugs are known for occasional and serious adverse reactions,

particularly on the cardiovascular system in humans. These

points have been discussed extensively in the international

articles published recently recommending that extraordinary

precautionary measures must be taken before opting to use

MCQ and AZM in COVID-19 patients (Annexure- A2/3).

vi. It is pertinent to mention that one may argue that

recommendation for “off-label” use of HCQ and AZM in ICU

patients with COVID-19 was justified because of the serious

situation and absence of any specific treatment against

COVID-19 (Annexure- A1). But even if this unproven and

“off-label” use of HCQ and AZM is used on COVID-19

patients, it would be even more important for taking all

necessary precautions to tackle the adverse reactions of these

drugs by close monitoring and timely intervention of the

37
patients as categorically recommended by the American

(Annexure- A2) and Canadian (Annexure- A3) studies to

save the life of the COVID-19 patients. Unfortunately, the

cryptic precautionary notes mentioned by Respondent no. 1

before using HCQ and AZM in Annexure- A1 falls far short

of the specific and comprehensive safeguards that must be

instituted for all COVID-19 patients treated with HCQ and

AZM, as highlighted under Annexure- A2/3, to prevent the

needless loss of life due to the unforeseen adverse reactions to

these drugs.

vii. That an extraordinary joint bulletin issued on 8th April,

2020 by the leading American cardiology societies

(AHA/ACC/HRS) has cautioned that use of HCQ and AZM

in COVID-19 patients can pose serious dangers due to its

inherent adverse effects (Annexure- A2). In order to protect

patients, the AHA/ACC/HRS bulletin has recommended the

following six specific precautionary therapeutic measures that

38
doctors must take before and during use of any HCQ and

AZM in COVID-19 patients:

a) ECG/QT interval monitoring.

b) Withhold Hydroxychloroquine and Azithromycin

in patients with baseline QT prolongation (e.g. > 500

msec) or with known congenital long QT syndrome.

c) Monitor QT rhythm and QT interval; withdrawal of

Hydroxychloroquine and Azithromycin if QTc

exceeds a present threshold of 500 msec.

d) In patients critically ill with COVID-19 infection,

frequent caregiver contact may need to be minimized,

so optimal electrocardiographic interval and rhythm

monitoring may not be possible.

e) Correction of hypokalemia >4mEq/L and

hypomagnesemia >2 mg/dL.

f) Avoid other QTc prolonging agents whenever feasible.

(emphasis added)

39
viii. That the Canadian Medical Association Journal

(CMAJ) published a very similar warning for using HCQ and

AZM to patients with COVID-19 vide an article published on

8th April, 2020 in CMAJ (Annexure- A3). The CMAJ article

also issued an almost identical cautionary note before using

HCQ and AZM to COVID-19 patients. In conclusion, the

CMAJ report also advised that doctors can mitigate the

uncommon but serious harms to COVID-19 patients for using

HCQ and AZM by careful patient selection and monitoring

(Annexure- A3).

ix. It is noteworthy that most of the cautionary measures

recommended in the AHA/ACC/HRS and CMAJ reports to

mitigate serious harms to the COVID-19 patients as a result

of treatment with HCQ and AZM were conspicuously absent

in the “Revised Guidelines on Clinical Management of

COVID-19” published on Health Ministry website on 31st

March, 2020 and widely circulated for doctors and healthcare

workers in India (Annexure- A1). For example,

40
AHA/ACC/HRS study has specifically cautioned that any

plan to use HCQ and AZM on COVID-19 patients should

exclude patients with known “congenital long QT syndrome”

because of their increased chance for developing serious

cardiac complications which is a known side effect of these

drugs. The recommendation by Respondent no. 1 to give

HCQ and AZM to COVID-19 patients with serious illness in

ICU does not give any warning that patients with known

“congenital long QT syndrome” should never be given this

combination drug therapy even though specific warning was

issued by Respondent no. 1 to other selected group of patients,

e.g. children and pregnant or lactating women were

specifically excluded from ever to be treated with HCQ and

AZM (Annexure- A1, p. 18). Other critical cautionary and

perhaps life-saving measures before using HCQ and AZM in

COVID-19 patients, e.g. close monitoring for hypokalemia

(low serum potassium) and hypomagnesemia (low serum

magnesium), as advised by AHA/ACC/HRS, were also

41
conspicuously absent in the treatment guidelines from

Respondent no. 1.

x. That apart from potential risks involved with the use of

HCQ and AZM as reported in studies from USA (Annexure-

A2) and Canada (Annexure- A3), a direct multi-national

study using large number of patients’ data, it was found that

combination of HCQ and AZM significantly increased the

risks of heart failure and cardiac mortality (Annexure- A4).

In order to inform the imminent and potentially life-threating

risks involved with use of HCQ and AZM for COVID-19

patients, especially patients with existing cardiac conditions

as reported in major international studies (Annexures-

A2/3/4), Petitioner submitted an urgent representation with

Respondent no. 1 urging them to take preventive and

precautionary measures in the treatment guidelines by

immediate implementation of the six specific therapeutic

steps as advised by the AHA/ACC/HRS to protect the lives of

the most seriously ill COVID-19 patients who are in ICU

42
(Annexure- A5). Unfortunately, Respondent no. 1 remained

absolutely silent and did not respond to Petitioner’s urgent

representation despite repeated follow-up requests.

xi. It is also pertinent to mention that it has become clear

that the unproven and anecdotal use of HCQ and AZM on

severely ill COVID-19 patients in ICU, as recommended in

the published treatment guidelines by Respondent no. 1

(Annexure- A1, p. 18), has well known and serious side

effects, particularly on the cardiovascular system, e.g.

irregular heartbeats, prolonged Q-T segment and heart failure

(Annexure- A2/3). The latest multi-national study with more

than 300,000 patients has also demonstrated that patients

treated with short-term combination of HCQ and AZM have

a significant increased risk of 30-day cardiovascular mortality

(Annexure- A4). Taken together, recent studies published in

top international medical journals suggest that at best, “off-

label” use of HCQ and AZM in COVID-19 patients while has

no specific anti-viral activities, even short-term use of these

43
two drugs together may cause serious adverse effects on

COVID-19 patients including abnormal heartbeat, heart

failure and increased cardiovascular mortality.

xii. It is most respectfully submitted that patients have

fundamental rights to know all pros and cons about his own

treatment, especially if this treatment is using “off-label”

drugs and primarily based on anecdotal evidence. The

concept of “informed consent” is well established in the

medical and legal parlance for a very long period. The

landmark judgment by a 3-judge bench of this Hon’ble Court

in Samira Kholi vs. Dr. Prabha Manchanda & Anr. (2008

SCC 2, 1) has defined “informed consent” quoting from

Taber’s Cyclopedic Medical Dictionary as (para. 14):

“Consent that is given by a person after receipt

of the following information: the nature and

purpose of the proposed procedure or treatment;

the expected outcome and the likelihood of

success; the risks; the alternatives to the

44
 procedure and supporting information

regarding those alternatives; and the effect of no

treatment or procedure, including the effect on

the prognosis and the material risks associated

with no treatment. Also included are instructions

concerning what should be done if the procedure

turns out to be harmful or unsuccessful."

(emphasis added)

The concept of “informed consent” was further

elaborated in the said judgment by quoting from guidelines to

doctors by the General Medical Council (GMC) in UK (para

18):

"Patients have a right to information

about their condition and the treatment

options available to them. The amount of

information you give each patient will vary,

according to factors such as the nature of the

45
 condition, the complexity of the treatment, the

risks associated with the treatment or

procedure, and the patient's own wishes.

(emphasis added)

And in regard to possible risks involved and informed

consent, the said judgment by this Hon’ble Court has further

held (para 21):

“Just as plainly, due care normally

demands that the physician warn the patient of

any risks to his well-being which contemplated

therapy may involve. The context in which the

duty of risk-disclosure arises is invariably the

occasion for decision as to whether a particular

treatment procedure is to be undertaken. To the

physician, whose training enables a self-

satisfying evaluation, the answer may seem clear,

but it is the prerogative of the patient, not the

physician, to determine for himself the direction

in which his interests seem to lie. To enable the

46
 patient to chart his course understandably, some

familiarity with the therapeutic alternatives and

their hazards becomes essential….(emphasis

added)

The concept of “informed consent” has undergone a

major shift in favor of the patients’ right following a recent

historic judgment by a 7-judge bench in the Supreme Court in

UK in Montgomery v. Lanarkshire Health Board (2015

UKSC 11). Relevant portions from this landmark judgment

is reproduced hereinbelow for ready reference:

82. “In the law of negligence, this approach

entails a duty on the part of doctors to take

reasonable care to ensure that a patient is aware

of material risks of injury that are inherent in

treatment. This can be understood, within the

traditional framework of negligence, as a duty of

care to avoid exposing a person to a risk of injury

which she would otherwise have avoided, but it is

also the counterpart of the patient’s entitlement

47
to decide whether or not to incur that risk. The

existence of that entitlement, and the fact that its

exercise does not depend exclusively on medical

considerations, are important. They point to a

fundamental distinction between, on the one

hand, the doctor’s role when considering possible

investigatory or treatment options and, on the

other, her role in discussing with the patient any

recommended treatment and possible

alternatives, and the risks of injury which may be

involved.

83. The former role is an exercise of

professional skill and judgment: what risks of

injury are involved in an operation, for example,

is a matter falling within the expertise of members

of the medical profession. But it is a non sequitur

to conclude that the question whether a risk of

injury, or the availability of an alternative form of

treatment, ought to be discussed with the patient

48
 is also a matter of purely professional judgment.

The doctor’s advisory role cannot be regarded as

solely an exercise of medical skill without leaving

out of account the patient’s entitlement to decide

on the risks to her health which she is willing to

run (a decision which may be influenced by non-

medical considerations). Responsibility for

determining the nature and extent of a person’s

rights rests with the courts, not with the medical

professions.” (emphasis added)

The guidelines framed by Respondent no. 1 for treatment of

seriously ill COVID-19 patients in ICU with an unproven and

non-specific combination therapy with HCQ and AXM based

on anecdotal evidence that also carry risks of potentially life-

threatening cardiovascular complications due to the inherent

side effects of the drugs, must be disclosed to the patients

and/or their families and proper “informed consent” must be

obtained before going into the venture of using these

experimental drugs to the patients. Adequate warnings about

49
 the adverse effects of this therapy should be included and

adequate precautionary measures must be added in the

treatment guidelines published by Respondent no. 1

(Annexure- A1).

3. Question of Laws:

a. Whether Respondent no. 1 can recommend unproven

anti-malarial (HCQ) and antibiotic (AZM) medicines

primarily based on anecdotal evidence that are known

to have potential life-threatening side-effects, for

treatment of acutely ill COVID-19 patients in ICU

without necessary warnings and precautions

(Annexure- A1)?

b. Whether “informed consent” must be obtained from

COVID-19 patients before starting an “off-label” use of

unproven and non-specific treatment with HCQ and

AZM by full disclosure of the potential and serious

risks of heart failure and death?

50
c. Whether treatment of ICU patients with COVID-19 in

hospitals across India with an experimental and

unproven combination of drugs, HCQ and AZM, with

known and potentially lethal side effects, as advised by

Respondent no. 1 (Annexure- A1, p. 18) violated the

fundamental right to life as enshrined under Article 21

of Indian Constitution?

d. Whether Respondent no. 1 can overlook the findings by

multi-national medical groups that treatment with HCQ

and AZM can significantly increase 30-day

cardiovascular mortality rate (Annexure- A4) and

takes no precautionary steps to change their guidelines

for treatment of COVID-19 patients with a combination

of HCQ and AZM?

e. Whether Respondent no. 1 can remain silent and takes

no action to the 6 specific preventive and precautionary

51
 therapeutic measures advised by recent American

(Annexure- A2) and Canadian (Annexure- A3)

studies?

f. Whether Respondent no. 1 is justified to completely

ignore the urgent appeal/representation made by the

Petitioner requesting them to take necessary and

immediate preventive and precautionary measures to

mitigate the serious risks involved with the “off-label”

use of HCQ and AZM in the management of COVID-

19 patients as advised by the American (Annexure-

A2) and Canadian (Annexure- A3) cardiac medical

experts?

g. Whether the Respondents have not been wrong in

deciding and dealing with such pandemic medical

issues so light-heartedly by adopting ad-hoc measures

to treat COVID-19 patients in ICU with an unproven

drug combination of HCQ and AZM without adequate

52
 preventive measures against serious and potentially

lethal adverse effects of these drugs?

4. GROUNDS:

i. BECAUSE seriously ill COVID-19 patients in ICU in

hospitals across India are subjected to a controversial,

unproven, non-specific and potentially toxic “off-label”

use of drugs, HCQ and AZM, as advised by

Respondent no. 1 in published treatment guidelines

(Annexure- A1, p. 18) but without the necessary

warnings or precautionary measures to prevent cardiac

complications and possible death, as found by recent

international medical publications (Annexures-

A2/3/4).

ii. BECAUSE the treatment guidelines put forward by

Respondent no. 1 recommended treatment of seriously

ill COVID-19 patients with “off-label” use of MCQ and

53
 AZM without any valid “informed consent” which is

mandatory as held by this Hon’ble Court in Samira

Kholi (Supra.) especially in view of the well-known

and potentially serious risks of side effects of these

medicines for causing heart failure or death as reported

by many international studies (Annexure- A2/3/4).

iii. BECAUSE the Respondent no. 1 has put forward

guidelines for treatment of critically ill COVID-19

patients in ICU with HCQ and AZM based primarily

on anecdotal evidence and refused to consider to make

necessary changes even after your Petitioner brought

attention to subsequent findings and warnings issued by

major internal medical studies about potential serious

cardiovascular risks that may precipitate as an adverse

effect of this combination drug therapy (Annexure-

A5).

54
iv. BECAUSE Respondent no. 1 has failed to take any

preventive or specific mitigating therapeutic steps to

minimize the risks of known side effects for the “off-

label” drug treatment of serious COVID-19 patients

with HCQ and AZM including serious cardiovascular

complications and heart failure as emphatically

recommended by leading international cardiac experts

(Annexures- A2/3). For example, the extraordinary

bulletin jointly published on 8th April, 2020 by major

American cardiac societies (AHA/ACC/HRS)

cautioned about the possible cardiac risks that may be

associated with COVID-19 patients treated with MCQ

and AZM. The AHA/ACC/HRS also recommended 6

specific precautionary therapeutic measures for doctors

who plan to use MCQ and AZM on COVID-19

patients. These necessary life-saving medical measures

include prompt withdrawal of MCQ and AZM if QT

segment (in ECG) is prolonged to 500 msec. or more

and immediate correction of hypokalemia (low serum

55
potassium) and hypomagnesemia (low serum

magnesium) as a result of adverse effects of these two

medicines (Annexure- A2). It is noteworthy that

recommendation for using MCQ and AZM on COVID-

19 patients in ICU was made by Respondent no. 1 on

31st March, 2020 (Annexure- A1) while the warnings

issued about potential dangers for using these drugs and

6-point recommendation for necessary preventive

measures to combat potential adverse outcome was

declared online by AHA/ACC/HRS on April 8, 2020

(Annexure- A2). Petitioner also wrote to Respondent

no. 1 informing them about the serious dangers

associated with MCQ and AZM treatment and

requesting them for making necessary changes to

implement the 6-point precautionary and preventive

measures, as recommended by AHA/ACC/HRS, to

protect the lives of seriously ill COVID-19 patients

through an urgent representation on April 9, 2020

(Annexure- A5) followed by repeated appeals via

56
 telephone and email to take necessary steps to prevent

any damage to the hapless patients. Unfortunately,

Respondent no. 1 did not respond to the repeated pleas

by Petitioner or took any step to comply with the 6-

point preventive recommendations by

AHA/ACC/HRS.

v. BECAUSE the present crisis with COVID-19

pandemic is likely to continue or even further aggravate

in the coming weeks and months and it is expected that

more and more seriously ill COVID-19 patients would

be treated with MCQ and AZM following the treatment

guidelines put forward by the Respondent no. 1

(Annexure- A1). Unless the immediate preventive

measures, as advised by the American (Annexure- A2)

and Canadian (Annexure- A3) medical experts, are

added to the existing treatment guidelines in India,

many COVID-19 patients may suffer or die due to the

known adverse effects of MCQ and AZM.

57
vi. BECAUSE large multi-national controlled study has

recently demonstrated that a combination of MCQ and

AZM used in COVID-19 patients significantly

increased 30-day chest pain/angina, heart failure and

cardiovascular mortality (Annexure- A4). Taken

together with the stark warnings about serious and

potentially life-threatening adverse effects of MCQ and

AZM issued by other major international medical

groups (Annexures- A2/3), there is no argument that at

this stage, it is a bounden responsibility for Respondent

no. 1 to look carefully into all recent scientific

evidences in regard to the pros and cons to rethink their

recommendation for using MCQ and AZM in COVID-

19 patients and in the minimum, to immediately

implement the 6 specific preventive and precautionary

therapeutic measures, as recommended by

AHA/ACC/HRS (Annexure- A2), in order to mitigate

the chance of any serious cardiac complications or

58
 death of patients due to the potential adverse effects of

these two medicines.

vii. BECAUSE the Respondents are wrong to

recommend “off-label” use of MCQ and AZM

in ICU patients with COVID-19 primarily

based on anecdotal evidence and without

adequate consideration to serious risks that

may be associated with this unproven

therapy as warned by several recent

international studies (Annexures- A2/3/4).

5. That it is submitted most respectfully that Petitioner-

organization gratefully acknowledges that the Respondents

may have done an admirable job in many ways to combat the

ongoing coronavirus pandemic through prompt sequestration

of patients suspected and/or infected with COVID-19 in a vast

country like India, but unfortunately, in regard to treatment of

59
 the most seriously ill COVID-19 patients, many of whom are

elderly individuals with pre-existing cardiovascular

conditions like ischemia, atherosclerosis and high blood

pressure, Respondent no. 1 has made a serious mistake by

ingoing warnings from the international medical community

and recommending an unproven, anecdotal, non-specific,

“off-label” use of MCQ and AZM to treat COVID-19 patients

without adequate preventive and precautionary therapeutic

measures in place. It is now imperative upon Respondent no.

1 to take all the precautionary specific medical steps, as

advised by AHA/ACC/HRS in Annexure- A2, without any

delay to minimize the chance of inflicting serious injuries or

death of COVID-19 patients due to wrong selection of

patients or harmful side effects of these drugs.

6. That as a benevolent society involved in protecting the

interests of the defenseless patients of India, the Petitioner has

no other relief or remedy available to itself except for the kind

and urgent intervention of this Hon’ble Court to direct the

60
 Respondent no. 1 for reconsideration of any use of MCQ and

AZM in COVID-19 patients and in the minimum, to

immediately implement the 6-point specific

recommendations made jointly by the American Heart

Association (AHA), American College of Cardiology (ACC)

and Heart Rhythm Society (HRS) in USA in order to save

potential loss of innocent patients due to cardiac

complications and heart failure (Annexure- A2).

7. That the petitioner has not filed any similar writ petition in

this Hon’ble Court or any other High Court in India.

8. That this Writ Petition being PIL in nature is being filed bona

fide and in the interest of justice.

9. MAIN PRAYERS

In the facts and circumstances narrated above, the Petitioner

humbly prays that this Hon’ble Court may graciously be pleased to:

61
a) Issue a writ of mandamus or any other appropriate writ,

order, or direction to Respondent no. 1 directing them to

immediately make necessary changes in the treatment

guidelines for seriously ill COVID-19 patients in ICU who

are receiving combination of MCQ and AZM as per the

recommendations made by the American (Annexure- A2)

and Canadian (Annexure- A3) reports.

b) Issue a writ of mandamus or any other appropriate writ,

order, or direction to Respondent no. 1 directing them to

take necessary steps for immediate implementation of all

the 6 specific preventive measures recommended in

Annexure- A2 in hospitals across India to protect the lives

of COVID-19 patients who are being treated with HCQ

and AZM.

c) Issue a writ of mandamus or any other appropriate writ,

order, or direction to Respondent no. 1 to obtain “informed

consent” from all COVID-19 patients for treatment with

HCQ and AZM by bringing necessary changes the

62
 treatment guidelines published on March 31, 2020

(Annexure- A1).

d) Any further or other order or orders be made and/or

direction or directions be given as to this Hon’ble Court

may deem fit and proper.

10. INTERIM PRAYERS

In the facts and circumstances narrated above, the this

Hon’ble Court may graciously be pleased to:

a) Direct Respondent no. 1 to take necessary steps for

immediate implementation of the 6 specific pre-cautionary

medical interventions in terms of prayer “b” above for

prevention of potential loss of life of COVID-19 patients

receiving HCQ and AZM as cautioned in Annexure P-2.

63
 b) Any further or other order or orders be made and/or

direction or directions be given as to this Hon’ble Court may

deem fit and proper.

AND FOR WHICH ACT OF KINDNESS, THE

PETITIONER SHALL AS DUTY BOUND, AS IN DUTY BOUND

SHALL EVER PRAY

Drawn by: Filed by:

Rabin Majumder (Dr. Kunal Saha)

AOR (1825) President,
People for Better Treatment (PBT)
Petitioner-in-person

Place: Ohio, USA

Drawn on: 13.04.2020
FILED ON: 14.04.2020

64