The Supreme Court of India: Allow the Review and Approval Process for Clinical Trial Applications to Resume

1. 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.

%o!ical fact-based and statistically supported thin#in! and decision ma#in! has been sidelined in favor of embellishment madefor-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 could only 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 0PACRI1 has launched this petition to ur!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!ni2e that the process is not perfect and that chan!es must be committed to

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 citi2ens5 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 and economic 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!ni2e 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 any process "ill provide to people and society. If "e are realistic "e must reco!ni2e that man#ind has never advanced "ithout it.

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 effectively prevent 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.

FACT: There is no statistical evidence to support that Indian citi2ens are bein! used as the "orld$s !uinea pi!s as is often proposed by the press and uninformed advocacy or!ani2ations. In fact India$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 1 798 "hile !lobally durin! the same period :; ;28 trials "ere re!istered officially in the <)5 about 2.8= of all re!istered studies. The opposite case is more li#ely !iven that most of the mar#eted medicines available in India "ere innovated and tested else"here.

FACT: A statistic "idely reported in the press often not e3plained fully has led to a massive "ave of condemnation and public discourse. )pecifically the data that 2 '9' people died durin! clinical trials of :>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 :81 777 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

)erious Adverse ,vent 0)A,1 / 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 6AT to be caused by the study dru! or trial related procedures. India has 1.2* people more than 18= of the "orld$s population "hile burdened "ith B22= of cases of disease. )o statistics prove that durin! a > year span '? people out of 1.2* died from their participation in research - research meant to advance treatments desi!ned to improve or save lives. &hile A6- loss of life is re!rettable and steps should be ta#en to prevent such loss there is by no means a !reater ris# of safety issues occurrin! in India than there is any other part of "orld "here the human race is "or#in! to advance science and save lives. The deaths in clinical trials are not uniCue to India. The trials in "hich India participated had )A,$s and deaths reported from other parts of the "orld.

FACT: In all of 271; ? !lobal clinical trials "ere approved 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. Dave people been saved or are "e actually losin! thousands of lives as a result of this stoppa!eE

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 Darmoni2ation / +ood Clinical Practice or ICD-+CP.

FACT: Recent le!islation reCuires 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 pill1 instead of the investi!ational dru!. These t"o reCuirements 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. The use 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.

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" treatments to 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 HfaithI. 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. Do" "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

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 reCuirements 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 not only 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. Anly 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

prevent dia!nose treat and rehabilitate the affected population - Clinical research has provided medical access to thousands 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

Supporters
Reasonsfor signing

.ost Popular %atest

.ahesh De!a

I6DIA

about 2; hours a!o

%i#ed 1;

It is really the slu!!ishness that 6+A and )upreme Court are only focusin! on problem.L *annin! Clinical Trials in India L is not a solution. )C 6+A and .edia don$t have #no"led!e about clinical trials. An the other hand the deaths due to tobacco products is still the ma@or cause in India has not been banned but clinical trials "hich causes #no"n deaths is tar!eted to be banned. 87= of !lobal clinical trials are conductin! in <)A and it doesn$t mean that <)A !overnment usin! their citi2ens as !uinea pi!s.
o

Pramesh )hanmu!ham
1 day a!o

I6DIA

%i#ed 9

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 Cuestions 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 clinical research - 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 Cuality research embedded stron!ly "ith the principles of bioethics it seems cruel to put unfair 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 Cuality biomedical research in the country.
o

PRITA. DAMRA
1 day a!o

I6DIA

%i#ed :

Clinical Trial is the only "ay to brin! novel molecules or alternate 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 materiali2ed everythin! at earliest.
o

Tapan#umar )hah

)I6+APAR, )I6+APAR,

about 21 hours a!o

%i#ed ;

&ho are !uinea pi!sE The ones "ho ta#e dru!s that have never been tested in India before AR 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 6AT 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.

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 Cualified 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. (or the 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 Cuiet 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 Cuestion of your life.
o

Ramesh"ar +aur

I6DIA

about 2: hours a!o

%i#ed ;

*ecause I used this type for my treatment

*ecause I used this type for my treatment PAAFA RA)TA+I

I6DIA

about 18 hours a!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 "ell informed or "ron!ly informed. Indian research caters to a hu!e population "ith different ethnicity. 6ot doin! clinical research in India is li#e @eopardi2in! the future !enerations to healthKdru! ha2ards "hich some people are not even able to anticipate. )o I feel clinical research must !et a +A A6O Also my ei!ht year old son feels that clinical research is very important because he does not "ant to see sic# people in his country. &a#e up peopleO
o

Ale3 Peter

+A6DDI6A+AR I6DIA

about 19 hours a!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

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 Cuality 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.
o

Girender )an!"an

D-D,RA*AD I6DIA

about 19 hours a!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.
o

Prem Pais

*A6+A%AR, I6DIA

about 1> hours a!o %i#ed 2

Clinical trials are essential for discovery of ne" treatments for the Indian people
o

*havani Geeravalli

I6DIA

about 1' hours a!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+APAR, )I6+APAR,

about 2; hours a!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
o

neha chandan

.<.*AI <6IT,D )TAT,)

about 2: hours a!o %i#ed 2

As of no" this is the finacial loss for the country and clinical research professionals but !radually "e "ill see that this "ill be the human loss since there "ill be no ne" medicine available. Duman loss "ill become more impactin! than financial loss. %et us see the lon! term perspective P avoid human lossesKdeaths due to this.
o

Gira@ )uvarna
1 day a!o %i#ed 2

I6DIA

Patients are safer "ithin the controlled hi!hly re!ulated environment of !ood Cuality ethical and compliant clinical research practice. Anly if the benefit to ris# ratio is positive "ould a person be as#ed by his doctor if he "ishes to be a part of a clinical trial. It is

only after he is informed and has fully understood "ould he consent of his o"n free "ill to participate. De can "ithdra" consent at any time "ithout sufferin! any adverse conseCuence or havin! to !ive any reason. De "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. Anly if re!ulatory and ethics committee approval happens can a trial be!in. Aver the years patients have been made safe for CR. ItNs time to no" save CR for patients.
o

.ohit .ehrotra

%I)%, I%

about 1: hours a!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 <) and other modern pro!ressive countries. &ithout !ood research patients in India "ill suffer in the lon! term.

Dr. Fayendra Duorah

I6DIA

about 1? hours a!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 si2e of the pupulation
o

Ravite@ R

I6DIA

about 1? hours a!o %i#ed 1

*ecause I oppose this misconception of L<sin! our fello" Indians as +uinea pi!sL. )ome"here I heard that in India Clinical Research Industry is the hi!hly re!ulated industry after Airlines Industry. That itself says about it. As mentioned in this petition many a times our re!ulations surpasses international standards and in each every step of the research "e have to under!o ri!orous Cuality chec#s and everythin! needs to be documented "ithin strin!ent timelines. ,very step of the conduct is follo"ed as per standard procedures policies protocol "hich have sound scientific bac# !round etc etc..in order ma#e sure the re!ulatory compliance. And in turn main ob@ectives of re!ulations are safety and "ell bein! of sub@ects. .oreover because of this sta!nancy there are

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.
o

Dr. Prafulla Patil

I6DIA

about 1? hours a!o %i#ed 1

As it is unnecessarily affectin! scientific advancement and the pro!ress of the country.

o

ruhi rupam

I6DIA

about 27 hours a!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 .
o

.ustafa Pardi"ala

I6DIA

about 27 hours a!o %i#ed 1

(or !ro"th of Clinical Trail Industry in India

Chandana Pal

D-D,RA*AD I6DIA

about 21 hours a!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 but someho" 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.