BEFORE THE HONBLE SUPREME COURT OF INDIA

Wrtit Petition filed under Article 32 of

WRIT PETITION NO. ____ OF 2012

(Vortex 2017 Moot Court Competition)

Swasthya Adhikar Manch . Petitioners

Versus

The Union of India . Respondent

Abstract Filed On Behalf Of The Respondents

Most Respectfully Submitted To The

COUNSEL APPEARING ON BEHALF OF THE PETITIONERS

A
Abstract on behalf of the Respondents
 TABLE OF CONTENTS:-

Sr. No. Particulars Page No.

1 Title Page A

2 Table of Contents B

3 Statement of Jurisdiction and Issues 1

4 Index of Authorities 2

5 Written Submissions 3-

6 Summary of Pleadings

7 Prayers

B
Abstract on behalf of the Respondents
 STATEMENT OF JURISDICTION :-

The Petitioners have approached the Honble Supreme Court of Indiana under Article 32 of
the Constitution of Indiana which reads as under:-

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

(3) Without prejudice to the powers conferred on the Supreme Court by clause ( 1 ) and ( 2 ),
Parliament may by law empower any other court to exercise within the local limits of its
jurisdiction all or any of the powers exercisable by the Supreme Court under clause ( 2 )

(4) The right guaranteed by this article shall not be suspended except as otherwise provided
for by this Constitution

STATEMENT OF ISSUES :-

1. Whether there is any immediate need to bring amendments to the law that will put in
place a stringent regulatory mechanism for conducting Clinical Trials in India?
2. Whether there should be any provision of punishment for those found violating the
norms laid down by the law relating to the Clinical Trials?
3. Whether there is any need for appointment of a committee to oversee the clinical
trials?
4. Whether there should be some provision for health insurance to the volunteers
participating in clinical trials and
5. Whether any provision is required for compensation for any permanent disability or
death of such volunteers?

C
Abstract on behalf of the Respondents
 INDEX OF AUTHORITIES :-

D
Abstract on behalf of the Respondents
 WRITTEN SUBMISSIONS :-

The Respondents herein most respectfully state and submit as under.

1. What Is A Clinical Trial :--

1.1 Clinical trials are research investigations in which people volunteer to test new
treatments, interventions or tests as a means to prevent, detect, treat or manage various
diseases or medical conditions. Some investigations look at how people respond to a new
intervention and what side effects might occur. This helps to determine if a new intervention
works, if it is safe, and if it is better than the interventions that are already available.

1.2 Clinical trials might also compare existing interventions, test new ways to use or
combine existing interventions or observe how people respond to other factors that might
affect their health (such as dietary changes).

1.3 The World Health Organization (WHO) definition for a clinical trial is

any research study that prospectively assigns human participants or groups of humans to
one or more health-related interventions to evaluate the effects on health outcomes.

Clinical trial interventions include but are not restricted to:

experimental drugs

cells and other biological products

vaccines

medical devices

surgical and other medical treatments and procedures

psychotherapeutic and behavioural therapies

health service changes

preventive care strategies and

educational interventions.

E
Abstract on behalf of the Respondents
Researchers may also conduct clinical trials to evaluate diagnostic or screening tests and new
ways to detect and treat disease.

2. Why Do We Need Clinical Trials :-

2.1 Clinical trials are essential to the development of new interventions. For example,
without clinical trials, we cannot properly determine whether new medicines developed in the
laboratory or by using animal models are effective or safe, or whether a diagnostic test works
properly in a clinical setting. This is because computer simulation and animal testing can only
tell us so much about how a new treatment might work and are no substitute for testing in a
living human body.

2.2 Clinical trials also permit testing and monitoring of the effect of an intervention on a
large number of people to ensure that any improvement as a result of the intervention occurs
for many people and is not just a random effect for a one person.

2.3 Most modern medical interventions are a direct result of clinical research. New
interventions for most diseases and conditions including cancer, heart disease, high blood
pressure and asthma have been developed through clinical research. Clinical trials often
lead to new interventions becoming available that help people to live longer and to have less
pain or disability.

2.4 Clinical trials can also help to improve health care services by raising standards of
treatment. Doctors and hospital staff involved in clinical trials are continually trained to
provide best practice patient care. Australian clinical trials are recognised internationally for
including very high quality patient care.

3. Role Of Cro In Clinical Trials:-

3.1 A Contract Research Organisation, also called Clinical Research Organization (CRO)
is a service organization that provides support to the pharmaceutical and biotechnology
industries in the form of outsourced pharmaceutical research services (for both drugs and
medical devices). CROs range from large, international full service organizations to small,
niche specialty groups and can offer their clients the experience of moving a new drug or
device from its conception to FDA marketing approval without the drug sponsor having to
maintain a staff for these services.

F
Abstract on behalf of the Respondents
3.2 There are over 1,100 CROs in the world, despite continued trends toward
consolidation (many CROs are being acquired in recent times or others go out of business)1
It is a very fragmented industry with the top 10 controlling 56.1% of the market in 20082 and
down to 55% in 2009.3 One estimate had the size of the market set to reach $24 billion in
20104 and set to grow at a rate of 8.5% through 2015.5

4. Arguments Advanced :-

4.1

5.

http://cdsco.nic.in/writereaddata/SC%20Order%2030th%20Sept%202013.pdf

http://pib.nic.in/newsite/PrintRelease.aspx?relid=146413

http://www.indiamedicaltimes.com/wp-content/uploads/2013/10/No-Clinical-trial-on-Global-
clinical-trials-including-New-Chemical-Entities-without-proper-mechanism-Supreme-
Court.pdf

1 "CRO Industry Could See More Consolidation, Experts Say" outsourcing-pharma.com 2013-06-20 Retrieved 2013-09-24
2https://web.archive.org/web/20100205075135/http://www.bioportfolio.com/cgi-bin/acatalog/The-Top-10-Contract-
Research-Organizations-Positioning_-performance-and-SWOT-analyses.html
3
Quintiles in $3bn investment deal". Outsourcing-pharma.com. 2008-01-02. Retrieved 2010-08-03.
4
Outsourcing-pharma.com. 2007-07-30. Retrieved 2010-08-03.
5
"Reportlinker Adds The CRO Market Outlook: Emerging Markets, Leading Players and Future Trends. | Trends
& Events > Trends from". AllBusiness.com. 2009-09-21. Archived from the original on August 31, 2010.
Retrieved 2010-08-03.

G
Abstract on behalf of the Respondents