Post on 04-Jun-2018
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The Supreme Court of
India: Allow the Reviewand Approval Process for
Clinical Trial Applications
to Resume1.
1.
2. Petition by
People for the Advancement of Clinical
Research - India
The recent decisions made in the Democratic
Republic of India leadin! to the suspension
of the revie" and approval process for any
ne" domestic and !lobal clinical trial
applications is a catastrophic mista#e. The
decision directly and ne!atively impacts the
lives of millions of Indian$s across the
country under the false premise that the
actions ta#en "ill protect those individuals.
http://www.change.org/organizations/people_for_the_advancement_of_clinical_research_-_indiahttp://www.change.org/organizations/people_for_the_advancement_of_clinical_research_-_indiahttp://www.change.org/organizations/people_for_the_advancement_of_clinical_research_-_indiahttp://www.change.org/organizations/people_for_the_advancement_of_clinical_research_-_india8/13/2019 The Supreme Court of India for Clinical Trials
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%o!ical fact-based and statistically supported
thin#in! and decision ma#in! has been
sidelined in favor of embellishment made-for-media headlines sound bites and ra"
unchec#ed passion. &hen combined "ith
court decisions made durin! the past 1'
months the result has been a nearly t"o
year shut do"n of "hat "as one of the
fastest !ro"in! and most promisin!
enterprises India has seen since the da"n of
the ne" millennium. (urthermore data from
(rost and )ullivan *oston Consultin! +roup
Price &aterhouse Coopers ,rnst and oun!
and PRT forecasted that the future couldonly have been bri!hter. Most importantly,
the vital flow of innovative new and
potentially life improving treatments
has come to a complete stop.
Therefore the People for the Advancement of Clinical
Research / India 0PACRI has launched this petition tour!e the )upreme Court of India to allo" the relevant
!overnment bodies to a!ain be!in revie"in! and
approvin! clinical trials. Throu!h this petition "e "ould
also li#e to brin! to the front the facts concernin!
clinical research that are bein! smud!ed in this very
public media trial. &e reco!nie that the process is notperfect and that chan!es must be committed to
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measured and made in order to meet Court
e3pectations / but a complete stop is a shortsi!hted
and unacceptable solution. PACRI is comprised of
ordinary individuals from the follo"in! !roups4 ordinary
healthy citiens5 patients5 !overnment officials5 health
enterprise professionals5 educators5 patient advocacy
!roups and more.
*elo" is a list of relevant facts and findin!s re!ardin!
the importance of clinical research to the physical andeconomic health of the people of India. Readers of this
petition "ill find that many of these facts lay in star#
contrast to the often va!ue data points bein! put
for"ard by the small- yet-loud !roups "ho have stood
in the "ay of any pro!ress in an effort to create
pro!ress void of ris#. The !roups fail to reco!nie that
their often emotive and misinformed statements are
only turnin! out to be more detrimental to the cause
they espouse / protection of the research participant.
The very nature of clinical research and of any
innovative enterprise is that pro!ress is often frau!ht
"ith ris#. ore than la" it is the individuals "ho have
to ensure that the ris# is balanced "ith the benefit anyprocess "ill provide to people and society. If "e are
realistic "e must reco!nie that man#ind has never
advanced "ithout it.
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FACT:6e" treatments cannot be brou!ht to mar#et
and become available at your local pharmacy "ithout
first under!oin! a ri!orous testin! process in the lab in
animals and then in humans in the clinic #no"n as
Clinical Research or Clinical Trials
FACT:Clinical research "hen properly conducted has a
!reat potential to help us understand the prevalence of
various diseases and help us to more effectivelyprevent dia!nose treat and rehabilitate the affected
population
FACT:Clinical research has been occurrin! in India for
decades and the conduct of !lobal clinical trials has
been occurrin! since 2778
FACT:There is no such thin! as a clinical trial "ithout
ris# for the volunteers "ho participate. The very nature
of a clinical trial is that it is a test to determine "hether
an investi!ational product can be proven to be a safe
and effective treatment.
FACT:The very individuals "ho "ant an e3cessive
amount of safe !uards imposed have very much
benefitted from the clinical research process and the
efforts of volunteers anytime they ta#e a medicine or
receive treatment from their physician.
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FACT:There is no statistical evidence to support that
Indian citiens are bein! used as the "orld$s !uineapi!s as is often proposed by the press and uninformed
advocacy or!aniations. In fact India$s sta#e in the
conduct of !lobal clinical trials is still very small4 The
number of clinical trials DC+I approved in India from
2717-2712 is 1798 "hile !lobally durin! the same
period :;;28 trials "ere re!istered officially in the 8
ne" dru!s bet"een 2778 and 2712 is very misleadin! /
and purposely so / it sells ne"spaper and attracts
"ebsite visitors. The fact is out of the estimated
:81777 people "ho participated in clinical trials
bet"een 2778 and 2712 '? died of trial related causes.
All other cases of death reported represent individuals
"ho died of somethin! else "hile participatin! in the
trial. If those people "ere in@ured or became ill durin!
the trial / for e3ample a person in a cancer trial falls in
an accident at home and dies / they are recorded as a
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)erious Adverse ,vent 0)A, / and officially trac#ed and
reported as part of the data pac#a!e associated "ith a
ne" dru! application. Therefore 2'9' of the people
reported in the ne"s to have died durin! a clinical trial
/ died from somethin! that "as determined 6T to be
caused by the study dru! or trial related procedures.
India has 1.2* people more than 18= of the "orld$s
population "hile burdened "ith B22= of cases of
disease. )o statistics prove that durin! a > year span
'? people out of 1.2* died from their participation inresearch - research meant to advance treatments
desi!ned to improve or save lives. &hile A6 loss of life
is re!rettable and steps should be ta#en to prevent
such loss there is by no means a !reater ris# of safety
issues occurrin! in India than there is any other part of
"orld "here the human race is "or#in! to advancescience and save lives. The deaths in clinical trials are
not uniue to India. The trials in "hich India
participated had )A,$s and deaths reported from other
parts of the "orld.
FACT:In all of 271; ? !lobal clinical trials "ereapproved for conduct in India. ,ssentially there has
been no advancement of treatments to"ard approval in
India for nearly a year due to "idespread overreaction
and fear. ave people been saved or are "e actually
losin! thousands of lives as a result of this stoppa!eE
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FACT:India$s +ood Clinical Practice standards / "hich
outline the processes for the conduct of clinical trials
are more strin!ent than those follo"ed by the
international community includin! leadin! clinical
research countries in the 6orth America &estern
,urope Fapan Australia and else"here titled / called
the International Counsel on armoniation / +ood
Clinical Practice or IC-+CP.
FACT:Recent le!islation reuires compensation paid to
clinical trial volunteers "ho do not receive the intended
therapeutic effect of the investi!ational dru! or "ho
receive a placebo 0su!ar pill instead of the
investi!ational dru!. These t"o reuirements are
e3otic cannot be found in any other part of the "orld
"here clinical research e3ists and stri#e ri!ht at the
heart of the very point of conductin! clinical trials. (irst
clinical trials are tests of investi!ational medicines so
the very point of the trial is to see if the treatment has
the intended effect. )econd to determine "hether the
treatment is actually "or#in! or if it$s simple the
perception of the patient a placebo is often used. Theuse of a placebo is a proven mechanism to help ensure
the validity of the treatment !roup results. Golunteers
are e3plained these thin!s as part of the informed
consent process before they even a!ree to participate
in the study.
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FACT:The )upreme Court is mandatin! the use of
audio and visual recordin!s of the consent process that
each clinical trial volunteer must !o throu!h "hen
decidin! to participate in the trial. This is another
unprecedented step not found in normal +ood Clinical
Practice any"here in the "orld "hether established or
emer!in! mar#et. The time costs and lo!istics of
implementin! such a measure "ill further slo" the
clinical research process and create unnecessary
delays in the advancement of potential ne" treatmentsto the patient population of India. The recommended
process also does not ta#e into account the t"o ma@or
!round realities of medical care in India.
FACT:The patient-doctor relationship in India is very
stron!ly based on Hfaith. This A-G process "ill
introduce an element of distrust and discomfort in that
relationship. Instead of encoura!in! real discussion on
health and treatment bet"een the doctor and the
patient it "ill only disen!a!e the t"o parties.
FACT:A ma@or proportion of the Indian population
culturally still protects the female !ender in a Jpurdah$
system. o" "ill "e deal "ith this cultural issue in the
li!ht of the ease of electronic transmission of data in
this technolo!ical a!e. &ho "ill protect their privacyE
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FACT:The revie" process that ne" clinical trial
applications !o throu!h in India is as ri!orous if not
more ri!orous than most other countries across the
"orld even those that have been conductin! trials for
many decades. The past 8 years have seen the
implementation of a number of ne" re!ulations and
strict reuirements aimed at ti!htenin! the revie"
process after some earlier incidents. The resultin! t"o
step process "hich has been in place for nearly t"o
years no" ensures that all ne" trial applications notonly under!o the scrutiny of the office of the Dru!s
Controller +eneral India - but due to le!islative chan!es
in 2717 - also no" under!o an in-depth evaluation by a
panel of 17 ob@ective physicians "ho have e3tensive
e3pertise in the therapeutic areaKdisease bein!
tar!eted by the clinical trial. nly after passin!successfully throu!h these t"o layers and then bein!
approved by independent ethics committees located at
each research center can the trial actually proceed.
Other Truths about Clinical esearch
- Clinical trials in India are re!ulated by a set of rules
that are in conformity "ith / and in some cases surpass
- !lobal standards
- The implementation of present set of rules must be
closely monitored before movin! the !oal post
- Clinical research "hen properly conducted has a !reat
potential to help us understand the prevalence of
various diseases and help us to more effectively
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prevent dia!nose treat and rehabilitate the affected
population
- Clinical research has provided medical access tothousands of patients since the policy chan!e in 2778
- )ince 2778 clinical research has !enerated
employment to thousands of professionals and has the
capacity to !enerate employment to a fe" hundred
thousands of such professionals
- Clinical research has contributed si!nificantly to the
!ro"th of laboratories ima!in! lo!istical support and
other services
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Supporters
Reasonsfor signing ost Popular
%atest
ahesh De!a I6DIA
o about 2; hours a!o
o %i#ed 1;
It is really the slu!!ishness that 6+ and )upreme
Court are only focusin! on problem.L *annin! Clinical
Trials in India L is not a solution. )C 6+ and edia
don$t have #no"led!e about clinical trials. n the other
hand the deaths due to tobacco products is still the
ma@or cause in India has not been banned but clinical
trials "hich causes #no"n deaths is tar!eted to be
banned. 87= of !lobal clinical trials are conductin! in
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As a cancer sur!eron and clinical researcher I feel that
the process of scientific pro!ress and biomedical
research is critical to improve the health of our
population. All of us "ho practice medicine #no" that it
is an ine3act science "ith a lar!e number of
unans"ered uestions and un#no"n facts. Clinical and
translational research are vital for these !aps in
#no"led!e to be filled. The fact that "e live lon!er
today than "e did as recently as 27 years bac# is
primarily because of the pro!ress made in clinicalresearch - both by industry and academic researchers.
As it is India has la!!ed !rossly behind developed
countries in biomedical research5 at a time "hen Indian
researchers are !ettin! their act to!ether and
proposin! hi!h uality research embedded stron!ly
"ith the principles of bioethics it seems cruel to putunfair obstacles in their path. &hile re!ulation is
important and "elcome they also need to be rational
and lo!ical. &hat is needed no" is effective
implementation of e3istin! rules and not #nee-@er#
reactions and the introduction of ne" restrictive and
unethical la"s. There is an ur!ent need to establish a
fair re!ulatory environment "hich facilitates and
promotes the conduct of hi!h uality biomedical
research in the country.
PRITA AMRA I6DIA
o 1 day a!o
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o %i#ed :
Clinical Trial is the only "ay to brin! novel molecules oralternate treatment options in our healthcare system.
6obody canNt deny itNs important. &e are la!!in!
behind dude to the present re!ulatory environment in
the country. ,very coin has t"o side. &e canNt i!nore
the importance @ust for fe" separate incidence.
Chan!es are al"ays "elcome since clinical trial is
directly related to our health but it is not the proper
"ay our @udiciary system is ma#in! the chan!es. &e
have already "asted appro3imately 2 years no" it is
the time to materialied everythin! at earliest.
Tapan#umar )hah )I6+APR, )I6+APR,
o about 21 hours a!o
o %i#ed ;
&ho are !uinea pi!sE The ones "ho ta#e dru!s that
have never been tested in India before R those "ho
participate in clinical trials and are treated "ith respect
and e3tremely "ell ta#en care ofE The patients "ho
participate in clinical trials are 6T treated li#e !uinea
pi!s. They are treated as !reat human bein!s "ho
support advancement of medical science for the
!reater !ood of the society for the !ood of millions of
patients "ho suffer from the diseases that they do.
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Clinical trials are not an income for the pharmaceutical
industry. They are rather an e3penditure and a heavy
one. They spend crores of rupees to ensure that the
trials are conducted ethically and overseen by "ell
ualified monitors "ho personally !o to the trial sites
and verify data to confirm that the ri!hts safety and
"ell bein! of patients are maintained and that the data
!enerated are cridible for e3trapolation to the lar!er
population of the country and the "orld. Clinical trials
are not optional5 in fact there is no other option. (orthe pharmaceutical industry doin! clinical trials is the
only "ay to prove that the dru!s are safe and effective
and only on the basis of clinical trials are the dru!s
approved in each country by the health authorities
after thorou!h evaluation.
Please do not let anyone mis!uide you. Read
understand consult e3perts and then ta#e your
decision. Do not #eep uiet because you may suffer
from a disease for "hich you donNt have a treatment in
India only because clinical trials on that dru! "ere not
performed in India. It is truly a uestion of your life.
Ramesh"ar +aur I6DIA
o about 2: hours a!o
o %i#ed ;
*ecause I used this type for my treatment
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*ecause I used this type for my treatment
PFA RA)T+I I6DIA
o about 18 hours a!o
o %i#ed 2
Research is an important aspect of further development
and pro!ress in every arena of life. &e cannot halt
research because of fe" people "ho are not "ellinformed or "ron!ly informed. Indian research caters to
a hu!e population "ith different ethnicity. 6ot doin!
clinical research in India is li#e @eopardiin! the future
!enerations to healthKdru! haards "hich some people
are not even able to anticipate. )o I feel clinical
research must !et a + 6O Also my ei!ht year old sonfeels that clinical research is very important because he
does not "ant to see sic# people in his country. &a#e
up peopleO
Ale3 Peter +A6DI6A+AR I6DIA
o about 19 hours a!o
o %i#ed 2
Clinical Research has a !reat social purpose- to find
more effective medicine and treatment procedure for
man#ind . 6o short cut to avoid the clinical research
.6o clinical research means ne" medicine. That is
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a!ainst the ri!ht to life of the patient. &hen standard of
care fails the patients "ho have life threatenin!
diseases desperately searchin! for the research
medicine as a last resort. In several times. it does
miracles.
Clinical research comes first. Clinical practice comes
second. &ithout clinical research Clinical practice "ill
be sta!nated soon.
Clinical research and practice should !o hand in hand.
Clinical Research re!ulation and monitorin! should be a
continuous process for a conductive environment .
Anybody can ima!ine to stop the clinical practice to
avoid the clinical in@uriesE
,very effective medicine and treatment save the life of
the millions .
In India thousands of patients life e3pectancy and
uality of life improved to a !reat e3tent because of the
clinical research .
"e are e3pectin! a more balanced and industry
informed order from supreme court soon.
Girender )an!"an D,RA*AD I6DIA
o about 19 hours a!o
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o %i#ed 2
I have active clinical trial research doctor and
practioner. 6ot doin! trials is !reat disadvanta!e to us
and to our patients and society at lar!e.
Prem Pais *A6+A%R, I6DIA
o about 1> hours a!o
o
%i#ed 2Clinical trials are essential for discovery of ne"
treatments for the Indian people
*havani Geeravalli I6DIA
o about 1' hours a!o
o %i#ed 2
y mother suffers from Par#insonNs Disease to "hich
cure can be found only if clinical trials are conducted
non stop. +ovt should not stop clinical trials as this
could mean loss of lives due to lac# of life savin! dru!s
comin! into the countryO
could mean loss of lives due to lac# of life savin!
dru!s comin! into the countryO
Tapan#umar )hah )I6+APR, )I6+APR,
o
about 2; hours a!o
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o %i#ed 2
&ho are "e punishin! by stoppin! clinical trials in
IndiaE The microscopic minority of people "ho may not
have done clinical trials "ell or the people of India "ho
need ne"er treatment optionsE
neha chandan
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only after he is informed and has fully understood
"ould he consent of his o"n free "ill to participate. e
can "ithdra" consent at any time "ithout sufferin! any
adverse conseuence or havin! to !ive any reason. e
"ill be treated free of cost for any adverse event that
may happen durin! and due to the clinical trial. &hen
indicated compensation "ill also be done. Careful
selection of the ri!ht investi!ator ri!orous trainin! and
close monitorin! audits and inspections are done.
nly if re!ulatory and ethics committee approvalhappens can a trial be!in. ver the years patients
have been made safe for CR. ItNs time to no" save CR
for patients.
ohit ehrotra %I)%, I%
o about 1: hours a!o
o %i#ed 1
It is critical for advancement of ne" treatments for
patients in India "hich has about 18= of the "orlds
population and over 27= of the disease burden. (or
India to !ro" in importance it must be place "here
science and research is encoura!ed and flourishes li#e
the
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o about 1? hours a!o
o %i#ed 1
In the lon! run "e "ill suffer since companies "ould
refuse to launch ne" products in India. &e are
behavin! as "e the only super po"er in "orld. "e need
to retrospect and thin# "hat "e have contribute till
date to the "orld e3cept the sie of the pupulation
Ravite@ R I6DIA
o about 1? hours a!o
o %i#ed 1
*ecause I oppose this misconception of L
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implications "e are noticin! in terms of business and
employment in this sector. The need of an hour is
effective implementations and re!ular chec#s rather
haltin! the entire process.
Dr. Prafulla Patil I6DIA
o about 1? hours a!o
o
%i#ed 1As it is unnecessarily affectin! scientific advancement
and the pro!ress of the country.
ruhi rupam I6DIA
o about 27 hours a!o
o %i#ed 1
6e" treatment are not available in mar#et "ithout the
first under!oin! a lab a preclinical trial and clinical trial
so clinical research and clinical trial is most important .
ustafa Pardi"ala I6DIA
o about 27 hours a!o
o %i#ed 1
(or !ro"th of Clinical Trail Industry in India
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Chandana Pal D,RA*AD I6DIA
o about 21 hours a!o
o %i#ed 1
India "ith its hu!e population and vast pool of
diseased needs an ever emer!in! ran!e of dru!s and
therapies. This could be possible only "hen the clinical
research industry "or#s in tandem "ith the societal
need. &e had started "ith a !reat promise butsomeho" lost the momentum mid "ay throu!h as this
industry "as sin!ularly ta#en for media inspection and
sympathy !arnerin!. The hi!hs attained "ere
beautifully blinded by the lo"s depicted by the media.
The industry came to a !rindin! halt almost ; years
bac# and today a country "hich "as sho"in! a !reat
promise in an upcomin! industry is tryin! to find a
footin! a!ain. (or the benefit of the society at lar!e and
the industry "hich caters to health and "ell bein! it is
hi!h time "e start the process of !ettin! and doin!
research trials a!ain . The chan!es in the policies and
the administration can !o on hand in hand "hile the
clinical trial processes resume.
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