The Supreme Court of India for Clinical Trials

8/13/2019 The Supreme Court of India for Clinical Trials

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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.
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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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13/22

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 %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 %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



17/22

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


20/22

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 %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

%i#ed 1As it is unnecessarily affectin! scientific advancement

and the pro!ress of the country.

ruhi rupam I6DIA


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 %i#ed 1

(or !ro"th of Clinical Trail Industry in India
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Chandana Pal D,RA*AD I6DIA


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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Documents

The Supreme Court of India for Clinical Trials