NMC-235

AALC National level moot court competition 2017

BEFORE THE HON’BLE SUPREME COURT OF INDIANA

A Writ Petition Filed Before the Hon’ble Supreme Court of Indiana under Article 32 Of
Constitution of Indiana

W.P.No:____/2017
BETWEEN:
MR.AHMED ...PETITIONER 1
V

BPK HOSPITAL ...RESPONDENT 1

CASPER PHARMACEUTICAL PVT LTD CO ...RESPONDENT 2
UNION OF INDIANA (THROUGH SECRETARY, MINISTRY Of Health) ...RESPONDENT 3
DRUGS CONTROLLER GENERAL OF INDIANA ...RESPONDENT 4

W.P.No:____ /2017
WITH
MS. ANJALI …PETITIONER 2
V

BPK HOSPITAL ...RESPONDENT 1

CASPER PHARMACEUTICAL PVT LTD CO ...RESPONDENT 2
UNION OF INDIANA (THROUGH SECRETARY, MINISTRY Of Health) ...RESPONDENT 3
DRUGS CONTROLLER GENERAL OF INDIANA ...RESPONDENT 4

__________________________________
MEMORANDUM FOR PETITIONER
__________________________________
PLACE: INDIANA
COUNSEL FOR PETITIONER

DATE: 19th March, 2017

NATIONAL LEVEL MOOTCOURT COMPETITION 2017 TABLE OF CONTENTS

TABLE OF CONTENTS

LIST OF ABBREVIATIONS .....................................................................................................................3

INDEX OF AUTHORITIES .......................................................................................................................4

STATUTES: .............................................................................................................................................4
CASES REREFFED: ............................................................................................................................... 4
BOOKS REFERRED: .............................................................................................................................4
DICTIONARY REFERRED: .................................................................................................................5
ELECTRONICS SOURCES: .................................................................................................................5

STATEMENT OF JURISDICTION ..........................................................................................................6

STATEMENT OF FACTS ..........................................................................................................................7

ISSUES RAISED..........................................................................................................................................9
Issue1. Whether A Writ Petition Can Be Filed Under Article 32 Of The Constitution
Of India Against A Private Company? .......................................................................................9
Issue2. Whether There Is Any Breach Of Privacy Policy (Confidentiality Pertaining
To The Personal Medical Information) By The Hospital Under The
Information Technology Act, 2000? ...........................................................................................9
Issue3. Whether The Doctors Employed At The Hospital Influenced The Decisions
Of The Patients By Down-Playing The Side Effects Of The Drug Belcomet? ..........................9
Issue4. Whether Due Process Has Been Followed In Compliance With Law While
Granting The Drug License By The DCGI? ...............................................................................9

SUMMARY OF ARGUMENTS ...............................................................................................................10

ARGUMENTS ADVANCED ....................................................................................................................11

PRAYER .....................................................................................................................................................22

MEMORANDUM FOR PETITIONER 2

NATIONAL LEVEL MOOTCOURT COMPETITION 2017 LIST OF ABBREVIATIONS

LIST OF ABBREVIATIONS

SL NO. ABBREVIATION FULL FORM

1. & And
2. AIR All India Reports
3. Art Article
4. BCI Bar Council Of India
5. Anr. Another
6. Ltd. Limited
7. DCGI Drugs Controller General of
Indiana
8. Etc. Etcetera
9. HC High Court
10. Hon’ble Honorable
11. http:// Hyper Text Transfer Protocol
12. LJ Law Journal
13. No. Number
14. p. Page
15. ¶ Paragraph
16. Ors Others
17. §/sec. Section
18. SC Supreme Court
19. SCC Supreme Court Cases
20. u/a Under Article
21. v. Verses
22. W.P. Writ Petition
23. www World Wide Web
24. UOI Union of India

MEMORANDUM FOR PETITIONER 3

NATIONAL LEVEL MOOTCOURT COMPETITION 2017 INDEX OF AUTHORITIES

INDEX OF AUTHORITIES

STATUTES:

1. Constitution of India
2. Drugs and cosmetics Act 1940
3. Drugs and cosmetics rules 1945
4. Indian medical council Act 1956
5. Indian medical council regulations 2002
6. Indian penal code
7. Information Technology Act 2000 and 2008(Amended).
8. Information Technology Regulation 2011
9. The Narcotic Drugs And Psychotropic Substances Act, 1985

FOREIGN STATUTES:

1. Data Protection Act, 1998.

CASES REREFFED:

1. Prabhakar Ramkrishna Jodh v. A. L. Pande

2. Vidya Ram v. S.J.N. College
3. Madhavan Pillai v. Balan
4. Binny Ltd. v. Sadasivan
5. R. Rajagopal v. State of Tamil Nadu
6. CBSE v. Aditya Bandopadhyay

BOOKS REFERRED:

1. P.M. Bakshi, The Constitution of India, Universal Law Publishing Co. Pvt. Ltd, 11th Ed.
2. M P Jain, The Indian Constitutional Law, 7th Ed.
MEMORANDUM FOR PETITIONER 4
NATIONAL LEVEL MOOTCOURT COMPETITION 2017 INDEX OF AUTHORITIES

3. Durga Das Basu, Commentaries on Constitution of India, 8th Ed.

4. H.K Saharey, Constitution of India-Analytical Approach,4th Ed., 2012.
5. Apar Gupta, Commentary on Information Technology Act, 2nd Ed.,2011.
6. Bhansali S.R, Commentaries on The Information Technology Act, 2015.

DICTIONARY REFERRED:

1. Naveen Chand Jain, Dictionary Of Law, 2nd Edition

2. Sally Wehneier, Oxford Advanced Learner’s Dictionary ,6th Edition
3. Black’s Law Dictionary,2nd E.d.

ELECTRONICS SOURCES:

1. http://lawkhoj.com/
2. https://indiankanoon.org/
3. http://www.supremecourtcases.com/
4. http://www.scconline.com/.
5. http://www.legalserviceindia.com/.
6. http://www.livemint.com/.
7. http://www.manupatrafast.com/.
8. http://www.vakilno1.com/.
9. http://www.cdsco.nic.in/
10. http://www.rfhha.org/
11. https://am.asco.org/
12. http://www.medindia.net/
13. http://www.rfhha.org/

MEMORANDUM FOR PETITIONER 5

NATIONAL LEVEL MOOTCOURT COMPETITION 2017 STATEMENT OF JURISDICTION

STATEMENT OF JURISDICTION

The Petitioner submits that this honorable Court has Jurisdiction to entertain this Petition

Case No: W.P No._______/2017

The Honorable Supreme Court of Indiana has the jurisdiction in this matter under

Article 32 and 139 A of the Constitution of Gondor which reads as follows:

“32. Remedies for enforcement of rights conferred by this Part

(1) The right to move the Supreme Court by appropriate proceedings for the enforcement of the
rights conferred by this Part is guaranteed

(2) The Supreme Court shall have power to issue directions or orders or writs, including writs in
the nature of habeas corpus, mandamus, prohibition, quo warranto and certiorari, whichever may
be appropriate, for the enforcement of any of the rights conferred by this Part”

&

“139A. Transfer of certain cases

(1) Where cases involving the same or substantially the same questions of law are pending before
the Supreme Court and one or more High Courts or before two or more High Courts and the
Supreme Court is satisfied on its own motion or an application made by the Attorney General of
India or by a party to any such case that such questions are substantial questions of general
importance, the Supreme Court may withdraw the case or cases pending before the High Court or
the High Courts and dispose of all the cases itself: Provided that the Supreme Court may after
determining the said questions of law return any case so withdrawn together with a copy of its
judgment on such questions to the High Court from which the case has been withdrawn, and the
High Court shall on receipt thereof, proceed to dispose of the case in conformity with such
judgment”

MEMORANDUM FOR PETITIONER 6

NATIONAL LEVEL MOOTCOURT COMPETITION 2017 STATEMENT OF FACTS

STATEMENT OF FACTS

1. Nagaria is a state in the Union of Indiana. The state has a very high literacy level and people are very
cognizant of their rights and duties.

2. Lakhpat is ghetto in the heart of the city with a population of around 4400 people living in it. Water is
the biggest issue these slum-dwellers encounter because water is scares and contaminated and the people
started suffering from bouts of diarrhoea, abdominal cramping, nausea and vomiting.

3. The people of Lakhpat area started suffering from bouts BSK Hospital (here in after to be referred as
“The Hospital”), provided full range of health facilities to the needs of the people. The Hospital as a part
of the social responsibility adopted the Lakhpat ghetto. Later as part of the initiative the Hospital
collected all medical information relating to the health and the same was stored in Cloud Storage using
the Standard Secure Sockets Layer Technology to allow the encryption of personal information. A
clause in their privacy policy also indicated the fact that the information would not be sold, trader or
even traded to a third party.

4. Despite the repeated treatment administered by the medical staff there were no improvements in the
health condition of the people which ultimately resulted in dehydration causing the death of 30 people in
Lakhpat which cause mass panic among the localities the doctors failed to find source of such disease
prevailing in the ghetto.

5. Caseper Pharmaceutical Pvt. Ltd. Co (hereinafter to be known as “Pharma Company”) is a company

registered in the year 2010. It uses technology and innovations to meet every day needs of all the
patients. The company in rder to promote its products gives free samples to the physician through
medical representatives.

6. Mr.Felix, who is a medical representative who visits the Hospital regularly finds this as an opportunity
for his company gain the goodwill in the Pharmaceutical Industry if they can come up with the cure for
the unknown disease. The Pharma Company approached the Hospital, offering them a profitable deal on
creating a cure for this unknown disease which not only give them fame but also monetary gain for both
the parties. To speed up their research, The Pharma Company requested the Hospital to give information
of the affected people of Lakhpat in order to find the root cause of the disease. The Hospital accepts the
same and provides the information. Through joint efforts of Pharma Company and the Hospital they

MEMORANDUM FOR PETITIONER 7

NATIONAL LEVEL MOOTCOURT COMPETITION 2017 STATEMENT OF FACTS

develop a drug called Belcomet. The application was with Drugs Controller General of Indiana (herein
after referred to as DCGI) for approval on 02/10/2016 and the same was approved on 20/11/2016.

7. The medication was administered twice a day for three days in a medical aid camp conducted by the
Hospital in association with the Pharma Company. The symptoms of the unknown disease reduced but
this came at the cost of people developing certain side effects due to excess active ingredients such as
urinary tract infection, insomnia, myalgia, nausea, and muscle spasm.

8. Mr.Ahmed, a resident of Lakhpat was affected with due to the side effects of the drugs and approached
the doctors pertaining to the same and doctor’s behaviour seemed suspicious and hence, decided to go to
the root of the problem through which he learnt the Hospital had breached privacy policy and filed a writ
petition seeking relief for violation of his fundamental rights and breach of privacy.

9. Ms.Anjali, who is a renowned violinist, was infected by the disease approached the hospital to cure her
of the unknown disease. The drug was administered into her arm. The active ingredients from the drug
lead to the side effects such as mayalgia and muscle spasm which resulted in gangrene in her arm which
led to the amputation of her arms.

10. She filed a writ petition before the Hon’ble Supreme Court of Indiana against the Hospital and the
Pharma Company for violating her fundamental rights by manufacturing sub-standard which led to such
situations and against Ministry of Health Affairs and DCGI for approving such a drug out into the
market.

11. The Pharma Company filed a Special Leave Petition to the Hon’ble Supreme Court of Indiana seeking
to combine both the pending cases before the High Court of Nagaria and Supreme Court of Indiana. The
Supreme Court of Indiana, granted the Special Leave Petition and combined both the cases for disposal
on 19/03/2017.

MEMORANDUM FOR PETITIONER 8

NATIONAL LEVEL MOOTCOURT COMPETITION 2017 ISSUES RAISED

ISSUES RAISED

Issue1. Whether A Writ Petition Can Be Filed Under Article 32 Of The Constitution Of India Against A
Private Company?

Issue2. Whether There Is Any Breach Of Privacy Policy (Confidentiality Pertaining To The Personal Medical
Information) By The Hospital Under The Information Technology Act, 2000?

Issue3. Whether The Doctors Employed At The Hospital Influenced The Decisions Of The Patients By Down-
Playing The Side Effects Of The Drug Belcomet?

Issue4. Whether Due Process Has Been Followed In Compliance With Law While Granting The Drug License
By The DCGI?

MEMORANDUM FOR PETITIONER 9

NATIONAL LEVEL MOOTCOURT COMPETITION 2017 SUMMARY OF ARGUMENTS

SUMMARY OF ARGUMENTS

1. Whether A Writ Petition Can Be Filed Under Article 32 Of The Constitution Of India Against A Private
Company?
It is most humbly submitted before this Hon’ble court that a writ petition can be filed against a private
company.

2. Whether There Is Any Breach Of Privacy Policy (Confidentiality Pertaining To The Personal Medical
Information) By The Hospital Under The Information Technology Act, 2000?
It is submitted That there has been a violation of privacy policy from the side of the Respondent. For
nondisclosure of information and for no guaranty for further protection.

3. Whether The Doctors Employed At The Hospital Influenced The Decisions Of The Patients By Down-
Playing The Side Effects Of The Drug Belcomet?
It is humbly stated that the decision of the people was duly influenced by the doctors by way of active
conciliation of information which is of essential importance. And could have influenced the decision
making ability of the people.

4. Whether Due Process Has Been Followed In Compliance With Law While Granting The Drug License
By The DCGI?
It is humbly submitted that the DCGI and The Ministry Of health has not performed its duty in accordance
with and thus has violated many laws, rules and regulation laid down by law. And finally we can state
that the licensing of the drug was not done on a legal basis.

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NATIONAL LEVEL MOOTCOURT COMPETITION 2017 ARGUMENTS ADVANCED

ARGUMENTS ADVANCED

Issue1: Whether A Writ Petition Can Be Filed Under Article 32 Of The Constitution Of India Against A
Private Company?

1.1 It is most humbly submitted before this Hon’ble Court that a writ petition can be filed under Article 32 of
The Indian Constitution.

1.2 A Kerala High Court Bench comprising of Ag. Chief Justice Mr. Ashok Bhushan, Justice A.M. Shaffique
and Justice A.K. Jayasankaran Nambiar, in an order delivered on 18th December, 2014, has held that a
Writ Petition is maintainable even against a private party.

1.3 Court observed, “In view of the above, it is clear that the ratio of four Judge judgment in Prabhakar
Ramkrishna Jodh v. A. L. Pande that a Writ Petition can be entertained at the instance of a teacher of a
private College affiliated to the College, whose service conditions are governed by a statutory provision
still holds good and no tinkering of the said ratio can be read in Vidya Ram v. S.J.N. College. The Full
Bench of this Court in Madhavan Pillai v. Balan and others followed the judgment in Vidya Ram’s
case without referring to the ratio of Prabhakar Ramkrishna Jodh’s case, which was a four Judge Bench
judgment and was binding.”

1.4 The Court hence held it maintainable stating that, “The fourth respondent College is undoubtedly a private
body, but it is obliged to carry on its function as per the statutory obligations imposed by the Act, 1985
and the Statutes framed thereunder.

1.5 The court reiterated its stance as was in the case of Binny Ltd. v. Sadasivan where the Supreme Court
observed discharged a public duty. This public function or duty was explained by the court in the S.D
Siddiqui case, “A private body or a person may be amenable to writ jurisdiction only where it may become
necessary to compel such body or association to enforce any statutory obligations or such obligations of

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NATIONAL LEVEL MOOTCOURT COMPETITION 2017 ARGUMENTS ADVANCED

public nature casting positive obligation upon it” that a writ will lie against a private body only when it
performed a public function or public duty.

1.6 It is pertinent to note that, Hospitals must comply with several rules and regulations for their functioning.
The Clinical Establishment (Registration and Regulation) Bill 2007 has to be complied for setting up
of the hospital and there are several legislations1 governing qualification, practise and conduct of the
professionals.

1.7 It is cardinal to note from the facts of the case that providing health facilities to the public is in nature of
obligation of public nature. The hospital has adopted the ghetto and has taken initiatives to provide free
health care to the population of Lakhpat Ghetto.

1.8 Despite the Hon’ble Court not having had the opportunity to consider the matter as it was left to the bastion
of the High Courts , the Supreme Court must take cognizance of the instant writ and law down a ratio that
will serve good cause for the generations to come and furtherance of the Right to Health , a fundamental
envisioned under Article 21 of the Indian Constitution.

1
1. Indian Medical Council Act, 1956
2.Indian Medical Council (Professional Conduct, Etiquettes, and Ethics Regulations 2002).
MEMORANDUM FOR PETITIONER 12
NATIONAL LEVEL MOOTCOURT COMPETITION 2017 ARGUMENTS ADVANCED

Issue2. Whether There Is Any Breach Of Privacy Policy (Confidentiality Pertaining To The Personal Medical
Information) By The Hospital Under The Information Technology Act, 2000?

2.1 It is most humbly submitted before this Hon’ble Court that there is intelligible breach of privacy policy
(Confidentiality of Personal Medical Information) by the Hospital under the Information Technology Act,
2000.

2.2 It is pertinent to note that Rule 2(i) of the Information Technology (Reasonable Security Practices and
Procedures and Sensitive Personal Data or Information) Rules, 2011, hereinafter referred to as the Data
Protection Rules clearly defines personal information as “any information that relates to a natural person,
which, either directly, or indirectly, in combination with other information available or likely to be
available with a body corporate, is capable of identifying such person”.

2.3 It is also relevant to note from the facts2 of the case that The BPK Hospital, hereinafter referred to as “The
Hospital”, collected all personal medical information relating to the people of Lakhpat and stored it in the
main cloud storage. A clause in their privacy policy was quite explicit in indicating the fact that they
would collect personal medical information and family background relevant to health from the patients
and further added that they would not sell trade or rent users information to others.

2.4 Rule 3 sub-clause (iii)3 and (v)4 of Data Protection Act5 defines the scope of Sensitive Personal Data or
Information exclusively speak about data pertaining to the health conditions and record of the parties.

2
Facts of the case.
3
(iii)physical, physiological and mental condition;
4
(v)medical records and history.
5
Rule 3 :Sensitive Personal Data or Information-Sensitive Personal Data or Information of a person means personal information which
consists of information relating to ;-

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NATIONAL LEVEL MOOTCOURT COMPETITION 2017 ARGUMENTS ADVANCED

2.5 It is quite evident that information collected by the Hospital falls under the ambit of either sub-clause (iii)
or (v) since the facts of the case are silent regarding the nature of medical information collected from the
patients.

2.6 Rule 6 of the Data Protection Act6 speaks Disclosure of Information. According to the aforesaid Rule
clearly states disclosure of sensitive personal data or information by body corporate to a third part shall
require prior permission from the providers of such information, who has provided such information under
lawful contract.

2.7 It is quite clearly mentioned in the private policy of the Hospital that they would not sell, trade or rent
users’ personal information to third parties. Per contra to what was earlier stated, the Hospital disclosed
the personal medical information which had collected to Casper Pharmaceutical Pvt.Ltd.Co hereinafter
referred to as the Pharma Company without giving intimation to the people who have furnished
information pertaining to their health as per the procedure prescribed under Rule 5 of Data Protection
Act7.

6
6.Disclosure of information.— (1) Disclosure of sensitive personal data or information
by body corporate to any third party shall require prior permission from the provider of
such information, who has provided such information under lawful contract or otherwise,
unless such disclosure has been agreed to in the contract between the body corporate
and provider of information, or where the disclosure is necessary for compliance of a
legal obligation:
Provided that the information shall be shared, without obtaining prior
consent from provider of information, with Government agencies mandated under the
law to obtain information including sensitive personal data or information for the
purpose of verification of identity, or for prevention, detection, investigation including
cyber incidents, prosecution, and punishment.
7
(3) While collecting information directly from the person concerned, the body
corporate or any person on its behalf snail take such steps as are, in the
circumstances, reasonable to ensure that the person concerned is having the
knowledge of —
(a) the fact that the information is being collected;
(b) the purpose for which the information is being collected;
(c) the intended recipients of the information; and
(d) the name and address of —
(i) the agency that is collecting the information; and
(ii) the agency that will retain the information.
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NATIONAL LEVEL MOOTCOURT COMPETITION 2017 ARGUMENTS ADVANCED

2.8 It is cardinal to note that S.66 of the Information Technology Act, 2000 deals with various computer
related offenses. It is evident from the facts of the case that there has been a clear breach of privacy on
part of the Hospital.

2.9 It is also pertinent to note that Indiana does not have any specific laws related to protection of Medical
Data. It is constructive to look at the Data Protection Act, 1998 8 in the United Kingdom. The Data
Protection (Subject Access Modification) (Health) Order 2000 provides that information need not be
disclosed if it would be likely to cause serious harm to the physical or mental health of the Data Subject
or any other person and describes the mechanisms for ensuring that decisions as to whether to disclose or
withhold information are taken by the appropriate health professional.

2.10 It was held in MphasiS BPO Fraud case in the year 2005 that, S.43 (A) was applicable due to the
unauthorized access involved to commit transactions.

2.11 Section 79 of IT Regulations talks about transfer of information and this section states that if personal
information or data is transferred to a third party say that same level of data protection to be ensured. But
such assumption cannot be made in this case as the third party (Pharma Company) has not agreed upon
any such provisions. We can ultimately make the hospital liable for not being able to protect the personal
information or data of the people.

8
S.55(5)- A person who offers to sell personal data is guilty of an offence if—
(a)he has obtained the data in contravention of subsection (1), or
(b)he subsequently obtains the data in contravention of that subsection.
S.55(1)- A person must not knowingly or recklessly, without the consent of the data controller—
(a)obtain or disclose personal data or the information contained in personal data, or
(b)procure the disclosure to another person of the information contained in personal data.
9
“7. Transfer of information.-A body corporate or any person on its behalf may transfer sensitive personal data or information including
any information, to any other body corporate or a person in India, or located in any other country, that ensures the same level of data
protection that is adhered to by the body corporate as provided for under these Rules. The transfer may be allowed only if it is necessary
for the performance of the lawful contract between the body corporate or any person on its behalf and provider of information or where
such person has consented to data transfer.”

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NATIONAL LEVEL MOOTCOURT COMPETITION 2017 ARGUMENTS ADVANCED

a. In R. Rajagopal v. State of Tamil Nadu10, the Supreme Court held that the petitioners have a right
to publish what they allege to be the life story/autobiography of Auto Shankar insofar as it appears
from the public records, even without his consent or authorisation. But if they go beyond that and
publish his life story, they may be invading his right to privacy.

b. The data protection, especially in India, cannot be over emphasised. The need is imperative from
two perspectives, first, as a mechanism to regulate privacy invading technology, and second, as a
prerequisite to outsourcing the business in international trade. The Indian Constitution contains no
explicit grant of privacy. However, this lacuna has not prevented the courts from carving out a
constitutional, “right to privacy”11, by a interpretation of the, “right to life”. The, “right to privacy”,
exists as a limited statutory right to data privacy under S. 43(b). The aforesaid Section provides
for a penalty in case of unauthorised extraction, downloading, copying any data from a computer,
computer system or computer network including the information or data held or stored in any
removable storage medium.

It is therefore submitted before this Hon’ble Court that the Hospital has clearly breached S.43A the Information
Technology Act, 200012. It is further submitted that the aggrieved party needs to be compensated adequately for
failure on the side of the Hospital to protect his data.

10
1995 AIR 264, 1994 SCC (6) 632
11
People’s Union for Civil Liberties v. Union of India, (1997) 1 SCC 301
12
S.43A- Where a body corporate, possessing, dealing or handling any sensitive personal data or information in a computer resource
which it owns, controls or operates, is negligent in implementing and maintaining reasonable security practices and procedures and
thereby causes wrongful loss or wrongful gain to any person, such body corporate shall be liable to pay damages by way of
compensation, not exceeding five crore rupees, to the person so affected. (Change vide ITAA 2008)
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NATIONAL LEVEL MOOTCOURT COMPETITION 2017 ARGUMENTS ADVANCED

Issue3. Whether The Doctors Employed At The Hospital Influenced The Decisions Of The Patients By Down-
Playing The Side Effects Of The Drug Belcomet?

3.1 It is most humbly submitted before this Hon’ble Supreme Court that the doctors employed at the hospital
influenced the decisions of the decisions of the patients by down-playing the side effects of the drug
BELCOMET.

3.2 If the decision or consent of the parties has been obtained by undue influence then the contract is voidable
at the option of the party whose consent has so been obtained and also provision to that effect is also
contained in the S.30 of The Specific Relief Act, 1963.

3.3 Sometimes, one of the parties to the contract may be in such a dominant position in relation to the other
that he has peculiar opportunity of exercising that position to the prejudice of the other party. If the
dominant party takes an undue advantage of his position, it will evidently result in Undue Influence. In
the following cases, a person is deemed to be in a position to dominate the will of another –
c. Where he holds a real or apparent authority over the other, or ,
d. Where he stands in a fiduciary relation to the other, or,
e. Where he makes a contract with a person whose mental capacity is temporarily or permanently
affected by reason of age, illness, or mental or bodily distress.

3.4 The fiduciary relationship is not exhausted by the few well-known relationships. Any relationship in which
one party enjoys the “active confidence” of another party who is to lean on him and is inclined to repose
implicit confidence in him is enough to approximate to the kind of relationship.

3.5 It is quite evident from the facts of the case that there was a fiduciary relationship between the diseased
who approached the Hospital and the doctors.

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NATIONAL LEVEL MOOTCOURT COMPETITION 2017 ARGUMENTS ADVANCED

3.6 The Supreme Court of Indiana in the case CBSE v. Aditya Bandopadhyay defined fiduciary relationship.
The term was defined “fiduciary” referred to a person having a duty to act for the benefit of another,
showing good faith and where such other person reposes trust and special confidence in the person owing
or discharging the duty. The fiduciary is expected to act in confidence and for the benefit and advantage
of the beneficiary, and use good faith and fairness in dealing with the beneficiary or the things belonging
to the beneficiary. If the beneficiary has entrusted anything to the fiduciary, to hold the thing in trust or to
execute certain acts in regard to or with reference to the entrusted thing, the fiduciary has to act in
confidence and expected not to disclose the thing or information to any third party

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Issue4. Whether Due Process Has Been Followed In Compliance With Law While Granting The Drug License
By The DCGI?

4.1 It is most humbly submitted before this Hon’ble Supreme Court that the due process has not been followed
in compliance with law while granting the license by the Drug Controller General of Indiana.

4.2 It is pertinent to note that there has been lapse of procedure at every stage of licensing of a new drug. It
is to be noted that application13 for a new drug is to be applied for clinical trial14 prior to the licensing of
the drug. It is crucial part of licensing of the drug.

4.3 In Indiana, clinical trials are governed by three phases15 before the licensing authorities grant permission
to the drug manufactures to manufacture the same. It’s a cardinal point to note that duration of time lapsing
between two trials in the same volunteer should be a minimum of 3 months. The volunteers should
preferably be covered under some insurance scheme. From the facts of the case we can drive home the
fact that drug was granted license in a month of application for license for a new drug.

4.4 Section 4 and 5 of D&C rules talks about the dispatch of samples for test and analysis and Record of
conditions of seal respectively read with Section 25 of D&C Act, which states as

“4. Dispatch of samples for test or analysis. __ (1) Samples for test or analysis under sub-section (4) of
section 25 of the Act shall be sent by registered post in a sealed packet, enclosed, together with a
memorandum in Form 1, in an outer cover addressed to the Director.”

13
S.122DA of Drugs and Cosmetics Regulations, 1945.
14
S.122DAA- Definition of Clinical trial: For the purpose of this Part, “Clinical trial” means a systematic study of new drug(s) in
human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamics and
pharmacokinetic) and /or adverse effects with the objective of determining safety and / or efficacy of the new drug.]
15
Human clinical trials (Phase-I), Exploratory clinical trials (Phase-II), Confirmatory clinical trials (Phase-III)

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4.5 As we can see the sample were delivered to the hospital by the pharma company by a representative Mr.
Felix which goes against those rules and Act.

4.6 S.26A of the Drugs and Cosmetic Act, 194016 gives confers power to the Central Government to prohibit
the manufacture, etc., of drug and cosmetic in public interest.

4.7 Since the excess ingredients in the drug has led to amputation of arm of Ms.Anjali which highlights the
fact that the drug is of a sub-standard nature and manufacturing of this drug can be attributed to lapse of
procedure in granting the license.

4.8 Facts of the case highlight the fact that DCGI took personal interest while granting the license to the drug.
The personal interest could have been due to pecuniary benefits the person in charge would receive from
the private players if the license was granted to the drug.

In light of the above arguments made it is humbly submitted before this Hon’ble Supreme Court that license
granted to the drug BELCOMET has to be reconsidered on the above contentions.

16
S.26A- Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any
drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value
claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification
and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official
Gazette, prohibit the manufacture, sale or distribution of such drug or cosmetic.]
MEMORANDUM FOR PETITIONER 21
NATIONAL LEVEL MOOTCOURT COMPETITION 2017 PRAYER

PRAYER

In the light of the facts and circumstances, the cases cited, issues raised, arguments advanced and
authorities cited, the petitioner humbly prays that this Hon’ble Court may be pleased to kindly:

1. Grant appropriate compensation to the respective Petitioners for the breach of IT ACT.

2. Grant for the prohibition of the manufacture of the Sub Standard Drug (BECLOMET) by
the power of writ of Mandamus vested with this honorable court.

3. Compensation for the violation of Fundamental rights by the Respondents to the

Petitioners respectively.

4. Direct the Ministry of Health to be made liable for not adhering to the procedure
mentioned in Law.

5. Direct the DCGI to reconsider the License granted to the drug Beclomet.

PLACE: INDIANA
COUNSEL FOR PETITIONER
DATE: 19th MARCH 2017

MEMORANDUM FOR PETITIONER 22