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Team Code: ---------

1ST MAHINDRA UNIVERSITY INTERNATIONAL MOOT COURT COMPETITION

Before
THE HON’BLE INTERNATIONAL COURT OF JUSTICE

FILED UNDER ARTICLE 226 OF THE CONSTITUTION OF SHALVAK

WRIT PETITION FILED U/A 226 IN THE HIGH COURT OF BHANU PRADESH
W.P. (CIVIL) NO. 22 OF 2022.

CENTRE FOR THERAPEUTIC LEGAL HEALING.......................................................................... PETITIONER

Vs.

STATE OF BHANU PRADESH & ORS......................................................................................... RESPONDENT

MEMORIAL for THE RESPONDENT


2023 NHRC- RGNUL HUMAN RIGHTS NATIONAL MOOT COURT COMPETITION R04

~ • TABLE OF CONTENTS • ~

1. INDEX OF AUTHORITIES............................................................................................III

2. LIST OF ABBREVIATIONS............................................................................................VI

3. STATEMENT OF JURISDICTION...............................................................................VII

4. STATEMENT OF FACTS............................................................................................VIII

5. ISSUES RAISED................................................................................................................X

6. SUMMARY OF ARGUMENTS.......................................................................................XI

7. ARGUMENTS ADVANCED..............................................................................................1

A. THE PRESENT CASE IS NOT MAINTAINABLE IN THE HIGH COURT OF


BHANU PRADESH.............................................................................................................1
A.1 PRINCIPLE OF ALTERNATE REMEDY................................................................1

B. THE HIGH COURT OF BHANU PRADESH CANNOT DIRECT FOR


FORMULATION OF MENTAL HEALTH REGULATION RELATED LAWS AND
POLICY GUIDELINES......................................................................................................4
B.1 DIRECTING ANY GOVERNMENT ORGAN TO FORMULATE LAWS IS
STRICTLY OUT OF THE PURVIEW OF THE HIGH COURT.....................................4
B.2 THE DIRECTIONS BY THE HIGH COURT FOR FORMULATING LAWS ARE
NOT CONSISTENT WITH THE CONSTITUTIONAL DUTIES ASSIGNED..............8
B.3 THERE IS A MISMATCH BETWEEN THE EXISTENCE OF LAWS AND
THEIR IMPLEMENTATION............................................................................................9

C. THE US-BASED E-COMMERCE PLATFORM ‘FLIPDEAL’ IS NOT LIABLE


FOR FACILITATING THE SALE OF UNPRESCRIBED MEDICINE.....................10
C.1 CALIOREGAMANTLE DOESN’T FALL UNDER RESTRICTED MEDICINES
AND IS AN OTC MEDICINE........................................................................................10
C.2 FLIPDEAL CANNOT BE HELD LIABLE FOR THE SELF-MEDICATION OF A
CUSTOMER....................................................................................................................11
C.3 THE CUSTOMERS WERE EXPECTED TO FOLLOW THE PRINCIPLE OF
CAVEAT EMPTOR.........................................................................................................12

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C.4 FLIPDEAL STRICTLY ADHERES TO THE LAWS AND REGULATIONS OF
THE REPUBLIC OF SHALVAK, INCLUDING THE INTERMEDIARY
GUIDELINES..................................................................................................................13

D. THE PHARMACEUTICAL COMPANY ‘MOON PHARMACEUTICAL PVT.


LTD.’ IS NOT LIABLE FOR MANUFACTURING THE DRUG WHICH IS
CONTENDED TO BE DANGEROUS FOR HEALTH.................................................15
D.1 THE COMPANY CONDUCTED ADEQUATE TESTS BEFORE BRINGING
CALIOREGAMANTLE INTO THE SHALVAKIAN MARKET..................................16
D.2 CALIOREGAMANTLE IS NOT A DANGEROUS DRUG....................................17
D.3 THE LISTING OF CALIOREGAMANTLE ON FLIPDEAL DID NOT
MISREPRESENT THE PROPERTIES OF THE MEDICINE.......................................18

8. PRAYER.........................................................................................................................XIII

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~ • INDEX OF AUTHORITIES • ~

CASES

1. Asif Hameed v. State of Jammu and Kashmir, AIR 1989 SC 1899....................................9


2. Ayaaubkhan Noorkhan Pathan v. State of Maharashtra and others, (2013) 4 SCC 465......3
3. Bhagwan Singh and Anr. V. Chief Settlement Commissioner, AIR 1968 P H 63..............2
4. Bharat Bribe Digumarti v. State, (2017) 2 SCC 18............................................................12
5. Binoy Viswam v. Union of India and Others, (2017) 7 SCC 59..........................................9
6. Buddhi Kota Subbarao (Dr.) v. K.Parasaran (1996) 7 JT 265.............................................3
7. Christian Louboutin Sas v. Nakul Bajaj, 2018 SCC OnLine Del 12215...........................15
8. Christian Louboutin Sas v. Nakul Bajaj, 2018 SCC OnLine Del 12215...........................14
9. Common Cause: A Registered Society v. Union of India (2017) 7 SCC 158.....................7
10. Commr. of Customs (Preventive) v. Aafloat Textiles (I) (P) Ltd., (2009) 11 SCC 18......13
11. Delhi Law Act v. Part C States (Laws) Act, 1951 AIR 332.................................................6
12. Dr Ashwini Kumar vs Union Of India Ministry Of Home, (2018) 17 SCC 476................6
13. Dr. S. K. Sinha v. Patna University and Ors, AIR 1965 Pat 253.........................................2
14. Fertilizer Corpn. Kamgar Union (Regd.) v. Union of India, 1981 (1) SCC 568.................3
15. Glaxosmithkline Consumer Healthcare Ltd. v. Heinz India, MIPR 2010 (3) 314.............20
16. Golak Nath v. State of Punjab, 1967 AIR 1643...................................................................9
17. Google France SARL v. Louis Vuitton Malletier SA, C-236/08.......................................14
18. Havells India Ltd. v. Amritanshu Khaitan, 2015 (62) PTC 64 (Del).................................20
19. I.R. Coelho (Dead) by LRs. v. State of Tamil Nadu, (1999) 7 SCC 580.............................7
20. Janata Dal v. H. S. Chowdhary and Ors, (1992) 4 SCC 305................................................1
21. Jayanti Lal Amrit Lal v. S.M. Ram, AIR 1964 SC 649.......................................................6
22. Kalpana Mehta and Others v. Union of India and Others (2017) 7 SCC 59........................8
23. Kazi Lhendup Dorji v. Central Bureau of Investigation, 1994 Supp (2) SCC 116..............3
24. Kesavananda Bharti v. State of Kerala, AIR 1973 SC 1461............................................6, 7
25. Kunal Bahl v. State of Karnataka, 2021 SCC OnLine Kar 15706.....................................12
26. Mallikarjuna Rao v. State of A.P., 1990 AIR 1251..............................................................6
27. Mc Donalds Hamburgers Ltd. v. Burgerking (UK) Ld., [1987] F.S.R. 112......................20
28. N.D. Jayal & Anr. v. Union of India & Ors. (2004) 9 SCC Para 20..................................17

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29. R & M.Trust v. Koramangala Residents Vigilance Group, 2005 (3) SCC 91.....................4
30. Raghid Ahamed v. Municipal Board Kairana, 1950 AIR 163.............................................2
31. Rai Sahib Ram Jawaya v. State of Punjab, AIR 1955 SC 549.............................................6
32. Ram Krishna Dalmia v. Justice Tendolkar, AIR 1958 SC 538............................................6
33. Reckitt & Colman of India Ltd. v. M.P. Ramachandran and Anr., 1999 PTC (19) 741....19
34. S.P.Gupta v. Union of India, 1981 Supp. SCC 87...............................................................3
35. Salubai Ramchandra vs Chandu Sadhu, (1965) 67 BOMLR 69..........................................9
36. Shri Deep Chand Bharti v. M/S Food Corporation of India, (2011) ILR 5 (DEL) 509.......2
37. Smt. Indira Nehru Gandhi v. Raj Narain, AIR 1975 SC 2299.............................................5
38. State of Himachal Pradesh and Others v. Satpal Saini, (2016) SCC OnLine HP 2161.......7
39. State of Rajasthan and Others v. Union of India and Others, 1977 AIR 1361....................7
40. Supreme Court Employees’ Welfare Association v. Union of India and Another, AIR
1990 SC 334.....................................................................................................................5, 7
41. Union of India (UOI) and Ors. vs. Pfizer Limited and Ors., MANU/SC/1611/2017.........19
42. Union of India v. Ilmo Devi, (2016) SCC OnLine SC 1933................................................5
43. UOI v. T.R.Verma, 1957 AIR 882.......................................................................................2
44. V.K. Naswa v. Home Secretary, Union of India and Others, (2012) 2 SCC 542................8
45. Whirlpool Corporation v. Registrar of Trade-marks, Mumbai & ors, (1998) 8 SCC 1.......2

ARTICLES AND BLOGS

1. Aileen Kavanagh, Judicial Restraint in the Pursuit of Justice, U.O.L.R.P.S. 1, (2009). 5


2. Anirudh, Can the Supreme Court ask the Government to Frame a Law, PRS Legislative
Research (February, 14, 2023, 1:08 PM), https://prsindia.org/theprsblog/can-the-
supreme-
court-ask-the-government-to-frame-a-law............................................................................5
3. Kamat, S.K. et al. (2020) “Over-the-counter medicines: Global Perspective and Indian
scenario,” Journal of Postgraduate Medicine, 66(1), p. 28. Available at:
https://doi.org/10.4103/jpgm.jpgm_381_19........................................................................19
4. SK Kamat et al., Over-the-counter medicines: Global Perspective and Indian scenario, 66
J Postgrad Med 28 (2020) https://pubmed.ncbi.nlm.nih.gov/31898596/............................10
5. Tej Bahadur Singh, Principle of Separation of Powers and Concentration of Authority, 4
& 5 J.T.R.I 1, 1-4, 1996.......................................................................................................5
6. Vasundhara Sirnate, Good Laws, Bad Implementation, The Hindu ( February 14, 2023,
2:01 PM), https://www.thehindu.com/opinion/lead/good-laws-bad-
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implementation/article5639799.ece......................................................................................9

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STATUTES, RULES & CONSTITUTIONAL PROVISIONS

1. Guidelines on Approval of Clinical Trial and New Drugs Point 8.2, Acts of Parliament,...
1949....................................................................................................................................17
2. Guidelines on Prevention of Misleading Advertisements and Endorsements for
Misleading.................................................. Advertisements, 202, Acts of Parliament, 1949
............................................................................................................................................19
3. INDIA CONST. art. 40, cl. A..............................................................................................4
4. New Drugs and Clinical Trials Rules, 2019, Acts of Parliament, 1949.............................16
5. The Information Technology (Intermediary Guidelines and Digital Media Ethics Code)
Rules, §3, 2021(India)........................................................................................................14
6. The Information Technology Act, 2000, §79, No. 21, Acts of Parliament, 2000 (India). 11

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2023 NHRC- RGNUL HUMAN RIGHTS NATIONAL MOOT COURT COMPETITION R04

~ • LIST OF ABBREVIATIONS • ~

ABBREVIATIONS EXPANSIONS

¶ Paragraph

SC Supreme Court

HC High Court

Hon’ble Honourable

Art. Article

AIR All India Reporter

SCC Supreme Court Cases

Ltd. Limited

v./ vs versus

Ors Others

Const. Constitution
sch Schedule

S Section

IT Information Technology
ILR Indian Law Review

PIL Public Interest Litigation

Moon Pharma. Moon Pharmaceuticals Pvt. Ltd

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2023 NHRC- RGNUL HUMAN RIGHTS NATIONAL MOOT COURT COMPETITION R04

~ • STATEMENT OF JURISDICTION • ~

The State of Bhanu Pradesh, the Respondent in the Writ Petition filed under U/A 226 of
The Constitution Of Shalvak in The High Court Of Bhanu Pradesh concerning the matter of
Centre for Therapeutic Legal Healing v State Of Bhanu Pradesh & Ors (W.P.(Civil) No.
22 of 2022) humbly submits to the jurisdiction of this Hon’ble Court.

Flipdeal and Moon Pharmaceutical Pvt. Ltd, the Respondents in the Writ Petition filed
under U/A 226 of The Constitution Of Shalvak in the High Court Of Bhanu Pradesh
concerning the matter of Centre for Therapeutic Legal Healing v State Of Bhanu
Pradesh & Ors (W.P.(Civil) No. 22 of 2022) humbly submits to the jurisdiction of this
Hon’ble Court.

The present memorandum sets forth the facts, contentions, and arguments in the present
case.

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~ • STATEMENT OF FACTS • ~

About The Nation:


The Republic of Shalvak is the third largest democratic country in the world, with 27
Provinces and 3 Centrally Administered Units. The Constitution of the Republic of Shalvak
provides six Fundamental Rights, including the Right to Life under Article 21 of the
Constitution and several other Human Rights and Statutory Rights, which are at par with the
International Documents, including the Universal Declaration of Human Rights etc.
Nandvan’s Case In Chandrikapur:
On 6th December 2022, the police in Chandrikapur district of Bhanu Pradesh, a province of
the Republic of Shalvak, received a complaint of the unnatural death of 6 members of a
family. The investigation results suggested that the head of the family, Mr Nandvan, was
suffering from heavy depression due to continuous harassment and pressure at the workplace.
There were no policies in the workplace regarding organisational behaviour-related training,
and no counsellor was available to assess the psychological status of the employees. He used
to take the ‘Calioregamantle’ tablet as an anti-depressant, which was not a prescribed
medicine. Nandvan searched on the internet about the best anti-depressant medicines
available in the market without a prescription and purchased the same online. He was always
afraid that if he lost his job due to office politics, his two minor children, his wife, and his
aged parents would have to undergo tremendous hardship as he would be the sole earner of
his family. On 4th December 2022, he had some altercations with his supervisor at the office.
He started shouting at the supervisor and threw his bag at him. The supervisor informed him
that disciplinary action would be taken against him. Nandvan came back and had dinner with
his family, and within 2 hours, all the family members died due to a heavy dose of
Calioregamantle medicine.
A suicide note was recovered from the body of Nandvan, where he stated that he was taking
this step due to extreme pressure and no one was responsible for his death. As there were no
suicide notes found from other family members, police assumed that Nandvan had secretly
mixed the Calioregamantle medicine in the dinner food the rest of the family members
consumed. Police registered the case of unnatural death. But the chargesheet included the
names of the supervisor and some colleagues with whom the altercation happened and who
came to stop Nandvan from physically assaulting the supervisor.

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The Medicine:
Calioregamantle medicine is restricted in other jurisdictions, as unprescribed doses could
cause a heart attack. ‘Moon Pharmaceutical Pvt. Ltd.’ which was manufacturing this
medicine in the Republic of Shalvak. The e-commerce platform ‘Flipdeal’, which facilitated
the sale of medicine, is hosted in the United States of America. The platform can be accessed
from the Republic of Shalvak. The drug was listed as ‘available’ when the investigation was
done. The information about the medicine on the web portal stated that this is the best
antidepressant medicine. It will not have many side effects except that it may cause slight
giddiness. It will not have a heavy effect on nerves. It also mentioned that the medicine can
be taken after food twice a day and will cause a calming and relaxing effect on the body.
Presently, ‘Flipdeal’ does not have any nodal officer or grievance redressal officer/office
situated in the said country. The availability of the medicine on the platform and the review
of the drug on the open platform may encourage people to buy it in large quantities without
knowing about any side effects. The case attracted the attention of an NGO named ‘Centre
for Therapeutic Legal Healing’, which filed a writ application in the High Court of Bhanu
Pradesh.

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~ • ISSUES RAISED • ~

The following issues have been placed before the Hon’ble High Court of Bhanu Pradesh to
adjudicate upon:

~ • ISSUE 1 • ~
Whether the present case is maintainable in the High Court of Bhanu Pradesh or not?

~ • ISSUE 2 • ~
Whether the High Court of Bhanu Pradesh can direct for formulation of Mental Health
Regulation related laws and policy guidelines?

~ • ISSUE 3 • ~
Whether the US based E-commerce platform ‘Flipdeal’ is liable for facilitating the sale of
unprescribed medicine?

~ • ISSUE 4 • ~
Whether the pharmaceutical company ‘Moon Pharmaceutical Pvt. Ltd.’ is liable for
manufacturing the drug which is contended to be dangerous for health?

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2023 NHRC- RGNUL HUMAN RIGHTS NATIONAL MOOT COURT COMPETITION R04

~ • SUMMARY OF ARGUMENTS • ~

A. THE PRESENT CASE IS NOT MAINTAINABLE IN THE HIGH COURT OF


BHANU PRADESH.

The respondents most humbly contend that the present petition has been brought before The
Hon’ble SC under Article 226 of the Constitution of Shalvak as a PIL is not maintainable.
Issues III and IV of the present petition are concerning the liability of Moon Pharma. and
Flipdeal due to their alleged deficiency in service. It must be noted that the State Consumer
Redressal Forum under the Consumer Protection Act, 1986 is the first forum that should have
been availed in this regard. The writ courts in the absence of exceptional circumstances can
refuse to entertain writ petitions and proceed with judicial review where the invoker has
failed to exhaust or take recourse to alternative remedies. The liability of Moon
Pharmaceuticals Pvt. Ltd. and Flipdeal with respect to the death of Mr. Nandvan and his
family are listed in the Sessions Court; additionally, the given Civil Writ Petition filed in the
Hon’ble High Court would be equally efficacious if filed in the State Consumer Dispute
Resolution Forum. Thus, it is evident that the present petition has not been filed for genuine
public interest but with the aim to increase the popularity of Centre for Therapeutic Legal
Healing.

B. THE HIGH COURT OF BHANU PRADESH CANNOT DIRECT FOR


FORMULATION OF MENTAL HEALTH REGULATION RELATED LAWS
AND POLICY GUIDELINES.

It is humbly submitted before the Hon’ble court that the High Court of Bhanu Pradesh cannot
direct for the formulation of Mental Health related laws and policy guidelines. It is to note
that directing any government organ to formulate laws is strictly out of the purview of the
High Court as has been established by various landmark precedents over time. Secondly, the
directions by the High Court for formulating laws are not consistent with the Constitutional
duties assigned as the duties of each government have been sufficiently delineated and the
Judiciary has the role to keep a check on the Executive’s actions and not intervening in the
matters of law-making. Lastly, there is a mismatch between the existence of laws and their

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implementation. The HC does not need to direct the State to formulate laws as there are

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sufficient laws and policies in place, but their execution is lacking which resulted in the
circumstances borne by Nandvan.

C. THE US BASED E-COMMERCE PLATFORM ‘FLIPDEAL’ IS NOT LIABLE


FOR FACILITATING THE SALE OF UNPRESCRIBED MEDICINE

It is humbly submitted to the Hon’ble High Court of Bhanu Pradesh that the US-based e-
commerce platform “Flipdeal” is not liable for facilitating the sale of unprescribed medicines.
The medicine Calioregamantle is not a restricted medicine in the Republic of Shalvak. It can
be regarded as an OTC and doesn’t require any prescription. Moreover, Flipdeal is only an
intermediary and has safe-harbour protection under Section 79 of the Information Technology
Act. Further, the platform cannot be held liable for those acts of the customers for which they
need to be aware themselves. Lastly, Flipdeal adheres to all the rules, regulations and laws of
the Republic of Shalvak, including the Information Technology (Intermediary Guidelines and
Digital Media Ethics Code) Rules, 2021. The platform acts merely as a third-party host, as a
platform between sellers and prospective buyers.

D. THE PHARMACEUTICAL COMPANY ‘MOON PHARMACEUTICAL PVT.


LTD.’ IS NOT LIABLE FOR MANUFACTURING THE DRUG WHICH IS
CONTENDED TO BE DANGEROUS FOR HEALTH

It is humbly submitted before the hon’ble court that Moon Pharma is not liable for
manufacturing the drug which is contended to be dangerous for health, the reasons for which
include, the company conducting adequate tests before bringing Calioregamantle into the
Shalvakian market, Calioregamantle is not a dangerous drug and its listing on Flipdeal did
not misrepresent the properties of the medicine. Firstly, there is ample evidence that Phase I
and II trials were conducted. As for the omission of Phase III trials, it was justified by virtue
of being done under New Drugs and Clinical Trials Rules, 2019. Secondly, the concerned
drug has been tested in various other jurisdictions along with Shalvak and does not fall under
Schedule H, H1 or X, because of which it can be safely concluded that it is safe. Lastly, by
virtue of Flipdeal being an intermediary and not a promoter, the details it contains cannot be
considered as an advertisement.

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~ • ARGUMENTS ADVANCED • ~

A. THE PRESENT CASE IS NOT MAINTAINABLE IN THE HIGH COURT OF


BHANU PRADESH.

¶1. The respondents most humbly contend that the present petition has been brought before
The Hon’ble SC under Article 226 of the Constitution of Shalvak as a Public Interest
Litigation (hereinafter, ‘PIL’).
¶2. PIL has been defined as ‘a legal action initiated in a court of law for the enforcement of
public interest or general interest of a specific community in which the public or the class of
the community have pecuniary or some interest by which their fundamental or legal rights
and liabilities are affected’1. As a result, 'appropriate legal action,' 'common good,' and
'infringement of a right' are all required for a PIL. Hence, it is respectfully contended that the
current petition is maintainable since the petitioner did not avail the alternate remedies
available to them.

A.1 PRINCIPLE OF ALTERNATE REMEDY

¶3. It is humbly submitted that the writ courts in the absence of exceptional circumstances
can refuse to entertain writ petitions and proceed with judicial review where the invoker has
failed to exhaust or take recourse to alternative remedies. Requirements to exhaust the
alternative remedies is considered to be fair and just as legislation has created an avenue for
redress. It is submitted that issues III and IV of the present petition are with regard to the
liability of Moon Pharmaceuticals Pvt. Ltd. and Flipdeal due to their alleged deficiency in
service. It must be noted that the State Consumer Redressal Forum under the Consumer
Protection Act, 1986 was the appropriate forum for the redressal of grievances in the present
case.

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1
Janata Dal v. H. S. Chowdhary and Ors, (1992) 4 SCC 305.

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¶4. In UOI v. T.R.Verma2, the SC has observed that “where an alternative or an


equally efficacious remedy is open to a litigant, the litigant should be required to pursue
that remedy and not invoke the jurisdiction to issue a prerogative writ.”
In the instant case, the petitioner ‘Centre for Therapeutic Legal Healing’ cannot approach the
Hon’ble High Court since he has not exhausted the efficacious alternative remedy that was
available to them. As observed by the court in Raghid Ahamed v. Municipal Board
Kairana3, “the existence of an adequate legal remedy is a thing to be taken into
consideration in the matter of granting writs”.
¶5. In Dr. S. K. Sinha v. Patna University and Ors4, the Patna HC stated that “when there is
an alternative remedy, which without being unduly onerous, provides an equally efficacious
remedy, relief to the petitioner must be denied by the court.”. In Bhagwan Singh and Anr.
V. Chief Settlement Commissioner5, the court contended “all orders passed by the HC
dismissing the writ petition can be rejected on the ground that an Alternative Remedy was
available to the petitioner which he should have availed before coming to this court.”
¶6. In Shri Deep Chand Bharti v. M/S Food Corporation of India6, the court held that
“the present suit is not maintainable as the plaintiff has not exhausted all other Alternative
Remedies”. Hence, the PIL filed by Centre for Therapeutic Legal Healing in the present
petition can be dismissed on the ground that an Alternative Remedy was available to the
petitioner which he failed to avail before coming to the court. Four exceptions of the
principle of Alternative Remedy were carved out by the SC in Whirlpool Corporation v.
Registrar of Trade-marks, Mumbai & Ors.7, namely,
a) Enforcement of fundamental rights;
b) Violation of principle of natural justice;
c) Hearings or proceedings being wholly without jurisdiction; and,
d) When vires of the enactment is challenged.
¶7. It is submitted that no Fundamental Rights have been infringed in the present case; the
government has time and again made Statutes and Regulations for the increase in
accessibility of Mental Healthcare. The Mental Health Act of 2017 aims to provide mental
healthcare and services for persons with mental illness and to protect, promote and fulfil
the rights of such

2
UOI v. T.R.Verma, 1957 AIR 882.
3
Raghid Ahamed v. Municipal Board Kairana, 1950 AIR 163.
4
Dr. S. K. Sinha v. Patna University and Ors, AIR 1965 Pat 253.
5
Bhagwan Singh and Anr. V. Chief Settlement Commissioner, AIR 1968 P H 63.

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6
Shri Deep Chand Bharti v. M/S Food Corporation of India, (2011) ILR 5 (DEL) 509.
7
Whirlpool Corporation v. Registrar of Trade-marks, Mumbai & ors, (1998) 8 SCC 1.

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persons during the delivery of mental healthcare and services although the Act may be
improved, the present scenario does not infringe the Fundamental Rights of citizens. None of
the above said exceptions of the principle of Alternative Remedy can be applied in the
present issue and the respondents contend that there is no infringement of Fundamental
Rights.
¶8. It must be noted that the liability of Moon Pharmaceuticals Pvt. Ltd. and Flipdeal with
respect to the death of Mr. Nandvan and his family are listed in the Sessions Court;
additionally, the given Civil Writ Petition filed in the Hon’ble High Court would be equally
efficacious if filed in the State Consumer Dispute Resolution Forum. Thus, it is evident that
the present petition has not been filed for genuine public interest but with the aim to increase
the popularity of Centre for Therapeutic Legal Healing.
¶9. The Hon’ble SC has previously held that whenever any public interest is invoked, the
Court must examine the case to ensure that there is in fact, genuine public interest involved. 8
‘A person acting bona fide and having sufficient interest in the proceeding of public interest
litigation will alone have a locus standi and can approach the Court to wipe out violation of
fundamental rights and genuine infraction of statutory provisions, but not for personal gain or
private profit or political motive or any oblique consideration.’9
¶10. Public Interest Litigation which is an important field in the administration of law should
not be “publicity interest litigation” or “private interest litigation” or “politics interest
litigation” or “paise income litigation”. There must be real and genuine public interest
involved in the litigation and not merely an adventure of knight errant or poke ones into for a
probe. “No litigant has a right to unlimited drought on the Court time and public money in
order to get his affairs settled in the manner as he wishes. Easy access to justice should not be
misused as a licence to file misconceived and frivolous petitions”, was observed in Buddhi
Kota Subbarao (Dr.) v. K. Parasaran.10
¶11. In S.P. Gupta v. Union of India11, it was emphatically pointed out that the relaxation of
the rule of locus standi in the field of PIL does not give any right to a busybody or
meddlesome interloper to approach the Court under the guise of a public interest litigant.
Krishna Iyer, J. in Fertilizer Corpn. Kamgar Union (Regd.) v. Union of India12 in
stronger terms stated “If a citizen is no more than a wayfarer or officious intervener
without any interest or concern

8
Ayaaubkhan Noorkhan Pathan v. State of Maharashtra and others, (2013) 4 SCC 465.
9
Kazi Lhendup Dorji v. Central Bureau of Investigation, 1994 Supp (2) SCC 116.
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10
Buddhi Kota Subbarao (Dr.) v. K.Parasaran (1996) 7 JT 265.
11
S.P.Gupta v. Union of India, 1981 Supp. SCC 87.
12
Fertilizer Corpn. Kamgar Union (Regd.) v. Union of India, 1981 (1) SCC 568.

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beyond what belongs to any one of the 660 million people of this country, the door of the
court will not be ajar for him.”
¶12. In R & M. Trust v. Koramangala Residents Vigilance Group 13 , it was observed that
‘the sacrosanct jurisdiction of Public Interest Litigation should be invoked very sparingly and
in favour of vigilant litigant and not for the persons who invoke this jurisdiction for the sake
of publicity or for the purpose of serving their private ends.’. Due to the aforementioned
reasons, the respondent submits that the present case is non-maintainable and should be
dismissed.

B. THE HIGH COURT OF BHANU PRADESH CANNOT DIRECT FOR


FORMULATION OF MENTAL HEALTH REGULATION RELATED LAWS
AND POLICY GUIDELINES

¶13. It is humbly submitted that the High Court of Bhanu Pradesh cannot direct for
formulation of Mental Health Regulation related laws and policy guidelines. The
aforementioned step by the High Court does not have sufficient constitutional standing and
precedential value, which furthers the violation of the provisions of law. The lack of authority
of the High Court to give such directions will be proved through three sub-issues: [B.1]
Directing any government organ to formulate laws is strictly out of the purview of the Court;
[B.2] High Court is subjected to the boundaries defined by the Constitution; [B.3] There is a
mismatch between the existence of laws and their implementation.

B.1 DIRECTING ANY GOVERNMENT ORGAN TO FORMULATE LAWS IS


STRICTLY OUT OF THE PURVIEW OF THE HIGH COURT

¶14. The functions of different organs of the Government have been sufficiently
differentiated so that one organ of the Government could not usurp the function of another. In
Constituent Assembly Debates, Prof. K.T. Shah, a member of the Constituent Assembly laid
emphasis to insert by amendment a new Article 40-A14 concerned with the doctrine of
separation of powers.

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13
R & M.Trust v. Koramangala Residents Vigilance Group, 2005 (3) SCC 91.
14
INDIA CONST. art. 40, cl. A.

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¶15. Article 40A reads: “There shall be complete separation of powers as between the
principal organs of the State, viz; the legislative, the executive, and the judicial.” 15 This is to
note that the government is not the law-making body in India. Enacting a law is the function
of Parliament and state legislatures. Additionally, even if the Court were to address the
correct authority, Courts in India have no authority to direct the legislature to frame a law.16
This may be said to violate the basic principle of “separation of powers” which states that the
executive, legislature, and judiciary should function independently of each other. Under the
Shalvak Constitution, the Supreme Court and the High Courts have the power to interpret
law. The Constitution does not give power to Courts to direct the framing of a law. The
aforementioned assertions have sufficient precedential value, out of which, a couple of
precedents have been mentioned below.
¶16. The Court in Supreme Court Employees’ Welfare Association v. Union of India and
Another17, had directed that no court can direct the legislature to enact a particular law.
Similarly, when an executive authority exercises the legislative power by way of subordinate
legislation pursuant to delegatory authority of the legislature, such executive authority cannot
be asked to enact a law which it has been empowered to do under delegated authority. 18 In
Union of India v. Ilmo Devi19, the High Court, in the exercise of the powers under Article
226 of the Constitution, also cannot direct the Government and/or the Department to
formulate a particular regularization policy. Framing of any scheme is no function of the
Court and is the sole prerogative of the Government.
¶17. In Smt. Indira Nehru Gandhi v. Raj Narain20, Hon’ble Justice Chandrachud observed:
“The American Constitution provides for a rigid separation of governmental powers into
three basic divisions the executive, legislative and judicial. It is an essential principle of the
Constitution that powers entrusted to one department should not be exercised by any other
department. The Australian Constitution follows the same pattern of distribution of powers.
Unlike these Constitutions, the Indian Constitution does not expressly vest the three kinds of
power in three different organs of the State. But the principle of separation of powers is not a

15
Tej Bahadur Singh, Principle of Separation of Powers and Concentration of Authority, 4 & 5 J.T.R.I 1, 1-4,
1996.
16
Anirudh, Can the Supreme Court ask the Government to Frame a Law, PRS Legislative Research (February,
14, 2023, 1:08 PM), https://prsindia.org/theprsblog/can-the-supreme-court-ask-the-government-to-frame-a-law.
17
Supreme Court Employees’ Welfare Association v. Union of India and Another, AIR 1990 SC 334.
18
Aileen Kavanagh, Judicial Restraint in the Pursuit of Justice, U.O.L.R.P.S. 1, (2009).
19
Union of India v. Ilmo Devi, (2016) SCC OnLine SC 1933.
20
Smt. Indira Nehru Gandhi v. Raj Narain, AIR 1975 SC 2299.
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magic formula for keeping the three organs of the State within the strict confines of their
functions, as the functions of each organ have been sufficiently delineated.”
¶18. In Kesavananda Bharti v. State of Kerala21, Hon’ble Chief Justice Sikri observed:
“Separation of powers between the legislature, the executive and the judiciary is a part of the
basic structure of the Constitution; this structure cannot be destroyed by any form of an
amendment.”
¶19. In Ram Krishna Dalmia v. Justice Tendolkar22 reported in, Hon’ble Chief Justice S.R.
Das opined that in the absence of specific provision for separation of powers in our
Constitution, such as there is under the American Constitution, some such division of powers
legislative, executive and judicial- is nevertheless implicit in our Constitution. The same view
was expressed in Jayanti Lal Amrit Lal v. S.M. Ram23.
¶20. In Dr Ashwini Kumar vs Union Of India Ministry Of Home 24, the court’s attention
was drawn to the report of Asian Centre for Human Rights which was based, inter alia, on the
information and data furnished by the Government of India in Parliament, acknowledging
1674 custodial deaths. India has consistently and unequivocally condemned and deprecated
custodial torture at international forums and has signed the UN Convention but the
Government’s reluctance to ratify the UN Convention, which envisages a comprehensive and
standalone legislation. Indian statutory law at present is not in harmony and Articles 51(c)
and 253 of the Constitution underscore the ‘constitutional imperative’ of aligning domestic
laws with international law and obligations. The court denied the prayer of the Court to direct
the executive or the parliament to formulate laws or make amendments to them.
¶21. In Rai Sahib Ram Jawaya v. State of Punjab25 reported in in which Hon’ble Chief
Justice B.K. Mukherjea observed: “The Indian Constitution has not indeed recognized the
doctrine of separation of powers in the absolute rigidity but the functions of the different
parts or branches of the Government have been sufficiently differentiated.”
¶22. In Mallikarjuna Rao v. State of A.P.26 this Court held that the court under Article 226
has no power to direct the executive to exercise its law-making power. In re Delhi Law Act
case27 Hon’ble Chief Justice Kania observed: “Although in the Constitution of India, there is
no express separation of powers, it is clear that a legislature is created by the Constitution and

21
Kesavananda Bharti v. State of Kerala, AIR 1973 SC 1461.
22
Ram Krishna Dalmia v. Justice Tendolkar, AIR 1958 SC 538.
23
Jayanti Lal Amrit Lal v. S.M. Ram, AIR 1964 SC 649.
24
Dr Ashwini Kumar vs Union Of India Ministry Of Home, (2018) 17 SCC 476.
25
Rai Sahib Ram Jawaya v. State of Punjab, AIR 1955 SC 549.
26
Mallikarjuna Rao v. State of A.P., 1990 AIR 1251.
27
Delhi Law Act v. Part C States (Laws) Act, 1951 AIR 332.
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detailed provisions are made for making that legislature pass laws. It is then too much to say
that under the Constitution the duty to make laws, the duty to exercise its own wisdom,
judgement, and patriotism in making law is primarily cast on the legislature. The Court
further implied that unless it can be gathered from other provisions of the Constitution, other
bodies executive or judicial are not intended to discharge legislative functions.
¶23. Constitutional Bench judgments in His Holiness Kesavananda Bharati Sripadagalvaru
v. State of Kerala and Anr.28 , State of Rajasthan and Others v. Union of India and
Others29 and I.R. Coelho (Dead) by LRs. v. State of Tamil Nadu30 have uniformly ruled
that the doctrine of separation of powers, though not specifically engrafted, is constitutionally
entrenched and forms part of the basic structure as its sweep, operation and visibility are
apparent. Constitution has made demarcation, without drawing formal lines, amongst the
three organs with the duty of the judiciary to scrutinise the limits and whether or not the
limits have been transgressed.
¶24. In the case of Common Cause: A Registered Society v. Union of India 31, there can be
no manner of doubt that the parliamentary wisdom of seeking changes in existing law by
means of an amendment lies within the exclusive domain of the legislature and it is not the
province of the Court to express any opinion on the exercise of the legislative prerogative in
this regard. In State of Himachal Pradesh and Others v. Satpal Saini 32, the Supreme Court
had overturned the directions given by the High Court to amend provisions of the state
enactment after what was described as the plight of large population of non-agriculturist
Himachalis. Reference was made to Supreme Court Employees’ Welfare Association33
(supra) that no writ of mandamus can be issued to the legislature to enact a particular
legislation nor can such direction be issued to the executive which exercises the powers to
make rules in the nature of subordinate legislation.
¶25. In Census Commr. v. R. Krishnamurthy34, the Court stated, “it is clear as noonday
that it is not within the domain of the courts to embark upon an enquiry as to whether a
particular public policy is wise and acceptable or whether a better policy could be evolved.
The court can only interfere if the policy framed is absolutely capricious or not informed by
reasons or totally

28
Kesavananda Bharti v. State of Kerala, AIR 1973 SC 1461.
29
State of Rajasthan and Others v. Union of India and Others, 1977 AIR 1361.
30
I.R. Coelho (Dead) by LRs. v. State of Tamil Nadu, (1999) 7 SCC 580.
31
Common Cause: A Registered Society v. Union of India (2017) 7 SCC 158.
32
State of Himachal Pradesh and Others v. Satpal Saini, (2016) SCC OnLine HP 2161.

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33
Supreme Court Employees’ Welfare Association v. Union of India and Another, AIR 1990 SC 334.
34
Census Commr. v. R. Krishnamurthy, (2015) 2 SCC 796.

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arbitrary and founded ipse dixit offending the basic requirement of Article 14 of the
Constitution”.

B.2 THE DIRECTIONS BY THE HIGH COURT FOR FORMULATING LAWS ARE
NOT CONSISTENT WITH THE CONSTITUTIONAL DUTIES ASSIGNED

¶26. The Judiciary is the guardian of Constitutional values and has its responsibilities laid
down very clearly in the Constitution. The act of directing the Executive to formulate laws
will qualify as judicial overreach, which is not permissible by the Law of the Land. The
function that the concerned High Court shall be expected to serve is to keep a check on the
violation of enforceable legal provisions by the state, and not to encroach upon the function of
the Executive or Legislature.
¶27. In Suresh Seth v. Indore Municipal Corpn.35, a prayer was made before the Court to
issue directions for appropriate amendment in the M.P. Municipal Corporation Act, 1956.
Repelling the submission, the Court held that it is purely a matter of policy which is for the
elected representatives of the people to decide and no directions can be issued by the Court in
this regard. The Court further observed that this Court cannot issue directions to the
legislature to make any particular kind of enactment. In this context, the Court held that under
our constitutional scheme, Parliament and Legislative Assemblies exercise sovereign power
to enact law and no outside power or authority can issue a direction to enact a particular kind
of legislation.
¶28. In Kalpana Mehta and Others v. Union of India and Others36, Mr. Justice Dipak
Misra, the then Chief Justice of India, under the headings ‘Supremacy of the Constitution’,
‘Power of judicial review’ and ‘Doctrine of separation of powers’, has held that the
Constitution is a supreme fundamental law which requires that all laws, actions and decisions
of the three organs should be in consonance and in accord with the constitutional limits, for
the legislature, the executive and the judiciary derive their authority and jurisdiction from the
Constitution.
¶29. In V.K. Naswa v. Home Secretary, Union of India and Others37, the Court in clear
and categoric terms had observed that we do not issue directions to the legislature directly or
indirectly and any such directions if issued would be improper. It is outside the power of
judicial review to issue directions to the legislature to enact a law in a particular manner, for

35
Suresh Seth v. Indore Municipal Corpn., (2005) 13 SCC 287.
36
Kalpana Mehta and Others v. Union of India and Others (2017) 7 SCC 59.
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V.K. Naswa v. Home Secretary, Union of India and Others, (2012) 2 SCC 542.

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the Constitution does not permit the courts to direct and advice the executive in matters of
policy.
¶30. In Salubai Ramchandra vs Chandu Sadhu38, the power of the High Court to make
rules is subject to the provisions of the Constitution. The High Court, therefore, cannot make
any rule which is inconsistent with any of the provisions of the Constitution. In Binoy
Viswam v. Union of India and Others39, this Court referring to the Constitution had
observed that the powers to be exercised by the three wings of the State have an avowed
purpose and each branch is constitutionally mandated to act within its sphere and to have
mutual institutional respect to realise the constitutional goal and to ensure that there is no
constitutional transgression. It is the Constitution which has created the three wings of the
State and, thus, each branch must oblige the other by not stepping beyond its territory.
¶31. In Golak Nath v. State of Punjab 40, it was observed that the three organs of the
government are expected to exercise their functions within their limits and keeping in mind
certain encroachments assigned by the constitution.
¶32. In Asif Hameed v. State of Jammu and Kashmir 41 reported in the Supreme Court
observed: “Although the doctrine of separation of powers has not been recognised under the
Constitution in its absolute rigidity but the Constitution makers have meticulously defined the
functions of various organs of the State. Legislature, executive and judiciary have to function
within their own spheres demarcated under the Constitution. No organ can usurp the
functions assigned to another. The Constitution trusts to the judgment of these organs to
function and exercise their discretion by strictly following the procedure prescribed therein.
The functioning of democracy depends upon the strength and independence of each of its
organs.”

B.3 THERE IS A MISMATCH BETWEEN THE EXISTENCE OF LAWS AND


THEIR IMPLEMENTATION

¶33. The existence of laws but lack of execution is not a novelty in various states. For a law
to be effective and for the people to reap the benefits of such laws and policies, it is essential
to ensure that laws are impactful for the people.42 It is to be noted that the Republic of
Shalvak currently has the Mental Healthcare Act 2017, which takes into consideration
concerns

38
Salubai Ramchandra vs Chandu Sadhu, (1965) 67 BOMLR 69.
39
Binoy Viswam v. Union of India and Others, (2017) 7 SCC 59.
40
Golak Nath v. State of Punjab, 1967 AIR 1643.
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41
Asif Hameed v. State of Jammu and Kashmir, AIR 1989 SC 1899.
42
Vasundhara Sirnate, Good Laws, Bad Implementation, The Hindu ( February 14, 2023, 2:01 PM),
https://www.thehindu.com/opinion/lead/good-laws-bad-implementation/article5639799.ece.

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prevalent with respect to mental health at workplaces and in general. There have been several
amendments to the National Health Policy, over the years. Furthermore, the government in
their budgetary promises launched a “National Tele-Mental Health Programme”. A toll-free
helpline number has been set up to provide quick and easy access to mental health-related
assistance. Till date, 35 Tele MANAS Cells in 23 States/UTs have been operationalised.
¶34. As can be inferred from the above-mentioned information, the High Court of Bhanu
Pradesh does not need to direct the formulation of laws and policies as there are ample of
them, in existence. The judiciary, instead, can issue a direction to strongly execute the same.

C. THE US-BASED E-COMMERCE PLATFORM ‘FLIPDEAL’ IS NOT LIABLE


FOR FACILITATING THE SALE OF UNPRESCRIBED MEDICINE

¶35. It is humbly submitted to the Hon’ble High Court of Bhanu Pradesh that the US-based e-
commerce platform “Flipdeal” is not liable for facilitating the sale of unprescribed medicine.
[C.1] Calioregamantle doesn’t fall under restricted drugs and is an OTC medicine. [C.2]
Flipdeal cannot be held liable for the self-medication of a customer, being merely a platform
for shopping. [C.3] Furthermore, the customers were supposed to follow the principle of
caveat emptor. [C.4] Lastly, Flipdeal strictly adheres to the laws and regulations of the
Republic of Shalvak, including the intermediary guidelines.

C.1 CALIOREGAMANTLE DOESN’T FALL UNDER RESTRICTED MEDICINES


AND IS AN OTC MEDICINE.

¶36. Over-the-Counter (OTC) Medicines are legally allowed to be sold by pharmacists


without needing a prescription. Technically, drugs are OTC unless they are stated explicitly
as prescription-only drugs43. In Shalvak, medicines are listed under different schedules in the
Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945. It must be
highlighted that in India, the phrase “OTC” has no legal definition. Thus, until explicitly
mentioned by the government, the medicine in question, Calioregamantle, can be regarded as
an OTC and doesn’t require any prescription by the customers. It must be noted that Flipdeal

43
SK Kamat et al., Over-the-counter medicines: Global Perspective and Indian scenario, 66 J Postgrad Med 28
(2020) https://pubmed.ncbi.nlm.nih.gov/31898596/.

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clearly mentioned all the information about the drug on its website, including dosage, side
effects and precautions44. Additionally, the medicine in question is also not a restricted
medicine in the Republic of Shalvak. Therefore, Flipdeal cannot be held liable for selling
restricted medicine on its platform.

C.2 FLIPDEAL CANNOT BE HELD LIABLE FOR THE SELF-MEDICATION OF A


CUSTOMER

¶37. Flipdeal is an evolving e-commerce platform, devoted to the satisfaction of its


customers. It has thousands of sellers and buyers, who transact on its platform. It does not
manufacture, procure, produce, list, advertise, sell or price any of the products made available
on its platform, including Plaintiffs' products. The same are listed by third-party sellers. The
information relating to the products, including those pertaining to guarantees, warranties,
returns, refund policies etc. are uploaded by third-party sellers and not provided by Flipdeal.
Flipdeal follows a definite procedure to register and verify the sellers, to ensure adequate
accountability and service for its customers. Being a “seller-friendly” platform, Flipdeal
allows the sellers to determine the prices and discounts for each of the products including the
title, description and images etc. Sellers are given the autonomy to manage their accounts.
Flipdeal also ensures that its customers get full information about the product they are buying
and about its seller.
¶38. It is humbly submitted by the respondent Flipdeal, that all the services provided by it are
that of a mere ‘Facilitator’ and Flipdeal is not an active participant and that the providing of
facilitation services does not take away its intermediary status. Flipdeal only provides a
marketplace for the integration of the sellers' goods, and it does not consummate the sale
between the seller and purchaser. It is further clarified that Flipdeal has no role in the
sourcing of the products i.e. what is to be sold and how it is to be sold. The seller retains the
title to the products. Thus, Flipdeal is merely an intermediary under Section 79 of the
Information Technology Act45. Section 79 of the IT Act absolves intermediaries from liability
in case of them being a mere platform. It reads as under:
¶ 39. “INTERMEDIARIES NOT TO BE LIABLE IN CERTAIN CASES
79. Exemption from liability of intermediary in certain cases.-

44
Para 9(c) of Moot proposition.
45
The Information Technology Act, 2000, §79, No. 21, Acts of Parliament, 2000 (India).

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(1) Notwithstanding anything contained in any law for the time being in force but subject to
the provisions of sub-sections (2) and (3), an intermediary shall not be liable for any third
party information, data, or communication link made available or hasted by him.
(2) The provisions of sub-section (1) shall apply if—
(a) the function of the intermediary is limited to providing access to a communication
system over which information made available by third parties is transmitted or
temporarily stored or hasted; or
(b) the intermediary does not—
(i) initiate the transmission,
(ii) select the receiver of the transmission, and
(iii) select or modify the information contained in the transmission; (c) the
intermediary observes due diligence while discharging his duties under this
Act and also observes such other guidelines as the Central Government may
prescribe in this behalf.”
¶40. In Kunal Bahl v. State of Karnataka46, the Hon’ble HC noted that an intermediary
cannot be responsible for the listing and sale of allegedly products by independent third-party
sellers on its marketplace by relying on the decision of the Apex Court in Bharat Bribe
Digumarti v. State47. The court further elaborated that “market place model of e-commerce”
is recognised in Indian law and policy by referring to Press Note 3 of 2016 issued by the
Department of Industrial Policy and Promotion, Ministry of Commerce and Industry,
Government of India recognises whereunder the e-commerce entity only plays the role of a
facilitator between the buyer and seller, and does not have ownership over the goods sold.
The court held that, “An intermediary would not be responsible and/or liable for sale of any
item not complying with the requirements under the Drugs and Cosmetics Act, 1949 on its
platform since the essential ingredients of Section 18 (1)(c) of the Act not having been
fulfilled. Neither Snapdeal nor its Directors can be prosecuted for the offence under Section
27(b)(ii) of the Act.”

C.3 THE CUSTOMERS WERE EXPECTED TO FOLLOW THE PRINCIPLE OF


CAVEAT EMPTOR.

46
Kunal Bahl v. State of Karnataka, 2021 SCC OnLine Kar 15706.
47
Bharat Bribe Digumarti v. State, (2017) 2 SCC 18.

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¶41. As an e-commerce platform, Flipdeal ensures adequate services and products for its
customers. However, the platform cannot be held liable for those acts of the customers for
which they need to be aware themselves.
¶42. The doctrine of Caveat Emptor was explained by the Hon’ble SC in the case of Commr.
of Customs (Preventive) v. Aafloat Textiles (I) (P) Ltd. 48, “As per Advanced Law Lexicon
by P. Ramanatha Aiyar, 3rd Edn., 2005 at p. 721 : Caveat emptor means “let the purchaser
beware”. It is one of the settled maxims, applying to a purchaser who is bound by actual as
well as constructive knowledge of any defect in the thing purchased, which is obvious, or
which might have been known by proper diligence. “Caveat emptor does not mean either in
law or in Latin that the buyer must take chances. It means that the buyer must take care.” (See
Wallis v. Russell [(1902) 2 IR 585 (CA)] , IR p. 615.).” The court further explained, “Caveat
emptor is the ordinary rule in contract. A vendor is under no duty to communicate the
existence even of latent defects in his wares unless by act or implication he represents such
defects not to exist.” (See William R. Anson, Principles of the Law of Contract 245, Arthur
L. Corbin, ed., 3d Am. Edn. 1919.) Applying the maxim, it was held that it is the bounden
duty of the purchaser to make all such necessary enquiries and to ascertain all the facts
relating to the property to be purchased prior to committing in any manner.”
¶43. In the current case, Flipdeal posted all the necessary information about Calioregamantle
medicine on the portal. The information about the medicine on the web portal stated that the
medicine will not have many side effects except that it may cause slight giddiness. It will not
cause a heavy effect on nerves. It also mentioned that the medicine can be taken after food
twice a day and will cause a calming and relaxing effect on the body. However, despite all the
information, it was upto the customers to remain cautious as to the dangers of ‘self-
medication’ and any side effects of Calioregamantle.

C.4 FLIPDEAL STRICTLY ADHERES TO THE LAWS AND REGULATIONS OF


THE REPUBLIC OF SHALVAK, INCLUDING THE INTERMEDIARY
GUIDELINES.

¶44. Flipdeal is a United States of America-based e-commerce platform. Nevertheless, it


strictly adheres to all the laws and regulations of the Republic of Shalvak. The platform, as an
e-commerce entity, is covered under the Information Technology (Intermediary Guidelines
and

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48
Commr. of Customs (Preventive) v. Aafloat Textiles (I) (P) Ltd., (2009) 11 SCC 18.

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Digital Media Ethics Code) Rules, 202149. The platform acts mere as a third-party host, as a
platform between sellers and prospective buyers.
¶45. In Christian Louboutin Sas v. Nakul Bajaj50, the Hon’ble Delhi HC observed “An
analysis of the said Section shows that an intermediary is not liable for third party
information, data, links hosted on the platforms. However, Section 79(2) and 79(3), qualify
the manner in which the said protection is granted to intermediary. The protection is not
absolute. Under Section 79(2)(b) the intermediary should not:
• initiate the transmission,
• select the receiver of the transmission and
• select or modify the information contained in the transmission.”
Flipdeal, as an e-commerce entity falls under the said definition of intermediary, and hence is
entitled to safe harbour defence.
¶46. In Google France SARL, Google Inc. v. Louis Vuitton Malletier SA 51 (hereinafter,
‘Google France’), the European Court, after reviewing the provisions of the EC Directive
89/104, Directive 2000/31 and Regulation 40/94 which stipulates the rights conferred by a
trademark, considered the position of intermediaries. The following principles can be culled
out from the said decision:
a. Exemptions from liability of intermediaries are limited to the technical process of
operating and giving access to a communication network. Such an exemption is needed for
the purposes of making the transmission more efficient.
b. The activity of the intermediary is merely technical, automatic and passive - meaning
thereby that the intermediary does not have any knowledge or control over the information
which is transmitted or stored.
c. The intermediary gets the benefit of the exemption for being a “mere conduit” and for
“caching”, when it is not involved in the information which is transmitted/translated.
d. If any service provider deliberately collaborates with the recipient of a service, the
exemption no longer applies.
e. In order for the service provider to continue to enjoy the exemption, upon obtaining
knowledge of any illegal activity, the service provider has to remove or disable access to the
information.

49
The Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, §3,
2021(India).
50
Christian Louboutin Sas v. Nakul Bajaj, 2018 SCC OnLine Del 12215.
51
Google France SARL v. Louis Vuitton Malletier SA, C-236/08.

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f. In order to constitute a mere conduit, the service provider should not initiate the
transmission, select the receiver of the transmission, or select or modify the information
contained in the transmission.
g. The storage of the information has to be automatic, intermediate and transient.
h. The provider should not obtain any data based on the use of the information.
The above judgement was referred by the court in Christian Louboutin Sas v. Nakul
Bajaj52, as it observed that, “Thus, in the EU, the national courts have to determine whether
the service provider has played an active role or not, and whether it has knowledge or control
all over the data which is stored by it.”
¶47. In Flipdeal’s case, the platform acts as a neutral e-commerce entity and doesn’t promote
any specific manufacturer or product. The platform also has a grievance redressal
mechanism, whereby our executives can be contacted by customers via calls or messaging
through chatbots. The entity also possesses a US-based Grievance Officer, as required by
Section 3(2) of the Information Technology (Intermediary Guidelines and Digital Media
Ethics Code) Rules, 2021. It must be highlighted that the entity falls under the category of
social media intermediary. As defined by Information Technology (Intermediary Guidelines
and Digital Media Ethics Code) Rules, 2021, “social media intermediary‘ means an
intermediary which primarily or solely enables online interaction between two or more users
and allows them to create, upload, share, disseminate, modify or access information using its
services;” As per Section 4 of the act, only the significant social media intermediaries or
SSMIs are required to appoint resident based Chief Compliance Officers and nodal officers.
Therefore, Flipdeal is under no obligation to appoint any resident-based officers in Shalvak,
being a mere social media intermediary.

D. THE PHARMACEUTICAL COMPANY ‘MOON PHARMACEUTICAL PVT.


LTD.’ IS NOT LIABLE FOR MANUFACTURING THE DRUG WHICH IS
CONTENDED TO BE DANGEROUS FOR HEALTH.

¶48. It is humbly submitted that ‘Moon Pharma.’ (‘the company’ hereinafter) has complied
with all the rules and regulations required to manufacture drugs in the Republic of Shalvak.
The same will be extensively discussed in the following sub-issues; [D.1] The company

52
Christian Louboutin Sas v. Nakul Bajaj, 2018 SCC OnLine Del 12215.
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conducted adequate tests before bringing Calioregamantle into the Shalvakian market, [D.2]
Calioregamantle is not a dangerous drug, [D.3] The listing of Calioregamantle on Flipdeal did
not misrepresent the properties of the medicine.

D.1 THE COMPANY CONDUCTED ADEQUATE TESTS BEFORE BRINGING


CALIOREGAMANTLE INTO THE SHALVAKIAN MARKET

¶49. Calioregamantle is an Over-The-Counter anti-depressant that has been extensively


researched and tested in other countries before it was brought into the territory of Shalvak.
The company has engaged experts in the field of mental health to create a medicine that is not
only effective but can also be taken daily, within the prescribed doses, without any adverse
effects. The medicine has been made using non-addictive ingredients, allowing Moon Pharma
to make it available to its customers through e-commerce websites like Flipdeal. It is humbly
submitted that the tests omitted from the trials of Calioregamantle were done in accordance
with the New Drugs and Clinical Trials Rules, 201953, which describes the procedure to
conduct clinical trials for new medicines and the Guidelines on Approval of Clinical Trial
and New Drugs that lays down further guidelines on the same. New Drugs and Clinical Trials
Rules, 2019 gives out the primary objective of conducting the various phases of trial.
¶50. Clinical drug development generally consists of four phases (Phase I-IV).
(a) Phase I: The objective of studies in this phase is the estimation of safety and tolerability
with the initial administration of an investigational new drug into humans.
(b) Phase II: (i) The primary objective of Phase II trials is to evaluate the effectiveness of a
drug for a particular indication or indications in patients with the condition under study and to
determine the common short-term side-effects and risks associated with the drug.
(c) Phase III: (i) Phase III studies have the objective of demonstration or confirmation of
therapeutic benefits.
(iii) For new drugs approved outside Shalvak, Phase III studies may need to be carried out if
scientifically and ethically justified, primarily to generate evidence of efficacy and safety of
the drug in Shalvakian patients when used as recommended in the prescribing information.
In case of an application of a new drug already approved and marketed in other countries,
where local clinical trial in Shalvak is waived off or not found scientifically justified for its
approval for manufacturing first time in the country, the bioequivalence studies of such drug,

53
New Drugs and Clinical Trials Rules, 2019, Acts of Parliament, 1949.

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as appropriate, is required to be carried out and the test batches manufactured for the purpose
shall be inspected before its approval”
¶51. The website lists that the ideal dosage of Calioregamantle is after food twice a day to
achieve a calming effect. The same has been confirmed through Phase I of the Clinical Trial,
which shows us that Phase I of the trial had been conducted. The website additionally lists
that the medicine would not have any major side effects except giddiness and would not
cause a serious effect on the nerves, which allows us to confirm that Phase II of the trials had
also been conducted. The clinical trial that had been omitted was Phase III since the medicine
was available for sale in other jurisdictions. This complied with the Guidelines on Approval
of Clinical Trial and New Drugs Point 8.2.54
¶52. Generally, the new drugs which are approved in one or more will be considered for
approval of manufacture/import & marketing of the drug in the country barring certain
exceptions that Calioregamantle does not meet.

D.2 CALIOREGAMANTLE IS NOT A DANGEROUS DRUG

¶53. Calioregamantle has not only been adequately tested in the Republic of Shalvak but is
also available in other jurisdictions as a restricted medicine. The medicine was not classified
under Schedule H, H1 or X which meant that it was safe enough to be consumed without
medical supervision. The contention that it is dangerous based on the fact that it may cause
heart attacks in unprescribed doses falls short for two reasons:
a. Demographic differences: While a medicine may be dangerous to individuals living in
other countries due to the variation in the standard of living, geographical conditions,
food intake and other differences, the same medicine can be safe for individuals living in
Shalvak. Making a decision on the safety of any drug must be left to the experts in the
field and not the court. The same was emphasised in N.D. Jayal & Anr. v. Union of
India & Ors.55 “This Court cannot sit in judgment over the cutting edge of scientific
analysis relating to the safety of any project. Experts in science may themselves differ in
their opinions while taking decisions on matters related to safety and allied aspects. The
opposing viewpoints of the experts will also have to be given due consideration after full
application of mind. When the Government or the authorities concerned after due

54
Guidelines on Approval of Clinical Trial and New Drugs Point 8.2, Acts of Parliament, 1949.
55
N.D. Jayal & Anr. v. Union of India & Ors. (2004) 9 SCC Para 20.

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consideration of all viewpoints and full application of mind took a decision, then it is not
appropriate for the court to interfere. Such matters must be left to the mature wisdom of
the Government or the implementing agency.”
b. Variation in Clinical Trial Process: We must note that some countries may have a more
strict approval process for their countries; it must be noted that this in itself is not a reason
why they must be considered superior to the process conducted in Shalvak as the
resources in these countries and its population might be starkly different from Shalvak. It
would also be important to refresh our memory and realise that these strict regulations
were also a reason why many medicines couldn’t make it to most countries in the
European Union during the Pandemic, causing a major health crisis.
¶54. It must be noted that there was no directness between the heart-attack that could have
happened as a consequence of consuming excessive amounts of Calioregamantle and the
current context where the medicines were knowingly overdosed to end the life of the
individual and their family. It is essential to bear in mind that the toxicity of any substance
becomes much higher in circumstances where they are over-consumed.

D.3 THE LISTING OF CALIOREGAMANTLE ON FLIPDEAL DID NOT


MISREPRESENT THE PROPERTIES OF THE MEDICINE.

¶55. It must be noted that the platform Flipdeal is a mere intermediary and not a promoter and
hence, the details within it should not be considered as an advertisement. In Shalvak, the
classification of a medicine as an antidepressant is determined by the Central Drugs Standard
Control Organization (CDSCO), which is the regulatory body established under the Drugs
and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. The CDSCO determines
the classification of a drug based on its intended use and therapeutic properties. According to
Merriam-Webster’s Medical Dictionary56 medicine is generally classified as an antidepressant
if it is used or tending to relieve or prevent depression. Antidepressants work by affecting the
balance of certain hormones that are involved in regulating mood.
¶56. It is important to note that the classification of a drug as an antidepressant is not a
guarantee of its safety or efficacy. Additionally, not all medications used to treat depression
are called antidepressants. Some may be labelled as “mood stabilizers” or “anxiolytics”
instead, depending on the specific indication they are approved for by the CDSCO. Although
most anti-

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56
Merriam-webster, https://www.merriam-webster.com/dictionary/antidepressant, last visited Feb 3,2023.

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depressants come under Schedule H1, H or X, a medicine does not come under the
classification of Schedule H, H1, or X by virtue of being called an anti-depressant.
¶57. The Schedule is determined by the CDSCO and the same must not be contested by
courts as mentioned in previously and reaffirmed in Union of India (UOI) and Ors. vs.
Pfizer Limited and Ors.57 “The Central Government under Section 26A does not refer
to and, therefore, mandate any previous consultation with the DTAB. On the contrary, the
Central Government may be "satisfied" on any relevant material that a drug is likely to
involve any risk to human beings etc. as a result of which it is necessary in public interest to
regulate, restrict or prohibit manufacture, sale or distribution thereof. So long as the
Central Government's satisfaction can be said to be based on relevant material, it is not
possible to say that not having consulted the DTAB, the power exercised under the said
Section would be non-established”. There is no separate category allotted for OTC medicines
in Shalvak and the drugs which do not come under the prescription medicines schedule are
generally sold as over-the-counter medicines.58
¶58. Guidelines on Prevention of Misleading Advertisements and Endorsements for
Misleading Advertisements, 202259 provide clarity on what would classify as a non-
misleading advertisements. It must be noted that the company’s claim that Calioregamantle is
“the best antidepressant medicine” was based on the fact that most medicines on the market
are addictive and have serious adverse effects and in comparison to those, the medicine is
safer and hence better. Additionally, listing did not comment on the efficacy of the medicine.
¶59. Merely making a tall, harmless claim, does not amount to misrepresentation, the same
can be interpreted when viewed from the lens of Reckitt & Colman of India Ltd. v. M.P.
Ramachandran and Anr.60 where the Calcutta High Court ruled that a seller may declare
that his goods are the best or better than his competitor’s, even if the declaration is false.
While making such a declaration, he may compare the benefits and drawbacks of his products
and those of his competitors; however, the seller is not permitted to defame the goods of his
competitors, and if there is no defamation, the competitor will have no cause of action to file
a case of misleading advertisement and disparagement.

57
Union of India (UOI) and Ors. vs. Pfizer Limited and Ors., MANU/SC/1611/2017.
58
Kamat, S.K. et al. (2020) “Over-the-counter medicines: Global Perspective and Indian scenario,” Journal of
Postgraduate Medicine, 66(1), p. 28. Available at: https://doi.org/10.4103/jpgm.jpgm_381_19.
59
Guidelines on Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements,
202, Acts of Parliament, 1949.
60
Reckitt & Colman of India Ltd. v. M.P. Ramachandran and Anr., 1999 PTC (19) 741.
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¶60. The differences between comparative advertising and disparaging (hence misleading)
advertisement were discussed in Havells India Ltd. v. Amritanshu Khaitan61: “In Mc
Donalds Hamburgers Ltd. v. Burgerking (UK) Ld. 62 followed in Glaxosmithkline
Consumer Healthcare Ltd. v. Heinz India63, it has been held that advertisements are not to
be read as if they are some testamentary provision in a Will or a clause in some agreement
with every word being carefully considered and the words as a whole being compared. In
Marico Ltd. vs. Adani Wilmar Ltd. 64 it has been held that in determining the meaning of an
advertisement, the Court has to take into account the fact that public expects a certain amount
of hyperbole in advertising and the test to be applied is whether a reasonable man would take
the claim being made as one made seriously.

DEFINITION OF COMPARATIVE ADVERTISING


¶61. Though comparative advertising has not been defined in the ASCI Code, yet Article
2(2a) of the Advertising Directive of EEC defines comparative advertising as "any
advertising which explicitly or by implication identifies a competitor or goods or services
offered by a competitor.”65 Bombay Chemicals Pvt. Ltd. v. Union of India66, where a
company that sells insecticides and pesticides was sued for misrepresentation based on the
claim that they used pyrethrum flowers grown in India to make their fertilisers, the quantity
required to make such pesticides was regarded as “too large” to be met by the cultivation in
India by the petitioners. The court held that although the defendants appeared to have
overstated their claim, this in itself would not amount to misrepresentation as the company
had a certificate to state that they had been using Indian pyrethrum flowers. In a similar
fashion, since the sale of Calioregamantle was approved by CDSCO, even if the adverse
effects appear to be overstated, the same cannot be contented to be a reason for
misrepresentation.

61
Havells India Ltd. v. Amritanshu Khaitan, 2015 (62) PTC 64 (Del).
62
Mc Donalds Hamburgers Ltd. v. Burgerking (UK) Ld., [1987] F.S.R. 112.
63
Glaxosmithkline Consumer Healthcare Ltd. v. Heinz India, MIPR 2010 (3) 314.
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64
Marico Ltd. vs. Adani Wilmar Ltd., CS(OS) No.246/2013.
65
Havells India Ltd. v. Amritanshu Khaitan, 2015 (62) PTC 64 (Del).
66
Bombay Chemicals Pvt. Ltd. v. Union of India, 1981 SCC OnLine Bom 467 (Para 18).

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~ • PRAYER • ~

Wherefore in the light of the facts of the case, issues raised, arguments advanced, and
authorities cited, may this Hon’ble Court be pleased to adjudge and declare that:

A. The present case i.e. W.P.(Civil) No. 22 of 2022. is not maintainable in the High Court of
Bhanu Pradesh.
B. The High Court of Bhanu Pradesh cannot direct for the formulation of Mental Health
Regulation-related laws and policy guidelines.
C. US-based E-commerce platform ‘Flipdeal’ is not liable for facilitating the sale of an
unprescribed medicine.
D. The pharmaceutical company ‘Moon Pharmaceutical Pvt. Ltd.’ is not liable for
manufacturing the drug which is contended to be dangerous to health.

And /Or,
Pass any other order that it may deem fit in the interest of justice, equity, and good
conscience.

s/d
On Behalf of Respondent

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