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, leading to the suspension of
the review and approval process for any new
domestic and global clinical trial applications
is a catastrophic mistake. The decision
directly and negatively impacts the lives of
millions of Indians across the country, under
the false premise that the actions taken will

protect those individuals. Logical, fact-based

and statistically supported thinking and
decision making has been sidelined in favor
of embellishment, made-for-media headlines,
sound bites and raw unchecked passion.
When combined with court decisions made
during the past 18 months, the result has
been a nearly two year shut down of what
was one of the fastest growing and most
promising enterprises India has seen since
the
dawn
of
the
new
millennium.
Furthermore, data from Frost and Sullivan,
Boston Consulting Group, Price Waterhouse
Coopers, Ernst and Young and PRTM
forecasted that the future could only have
been brighter. 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 (PACRI) has launched this petition to
urge the Supreme Court of India to allow the relevant
government bodies to again begin reviewing and
approving clinical trials. Through this petition we would
also like to bring to the front the facts concerning
clinical research that are being smudged in this very

public media trial. We recognize that the process is not

perfect and that changes must be committed to,
measured and made in order to meet Court
expectations but a complete stop is a shortsighted
and unacceptable solution. PACRI is comprised of
ordinary individuals from the following groups: ordinary
healthy citizens; patients; government officials; health
enterprise professionals; educators; patient advocacy
groups and more.
Below is a list of relevant facts and findings regarding
the importance of clinical research to the physical and
economic health of the people of India. Readers of this
petition will find that many of these facts lay in stark
contrast to the often vague data points being put
forward by the small- yet-loud groups, who have stood
in the way of any progress in an effort to create
progress void of risk. The groups fail to recognize that
their often emotive and misinformed statements are
only turning 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 progress is often fraught
with risk. More than law, it is the individuals who have
to ensure that the risk is balanced with the benefit any
process will provide to people and society. If we are
realistic, we must recognize that mankind has never
advanced without it.

FACT: New treatments cannot be brought to market

and become available at your local pharmacy without
first undergoing a rigorous testing process in the lab, in
animals and then in humans in the clinic, known as
Clinical Research or Clinical Trials

FACT: Clinical research when properly conducted has a

great potential to help us understand the prevalence of
various diseases and help us to more effectively
prevent, diagnose, treat and rehabilitate the affected
population

FACT: Clinical research has been occurring in India for

decades and the conduct of global clinical trials has
been occurring since 2005

FACT: There is no such thing as a clinical trial without

risk for the volunteers who participate. The very nature
of a clinical trial is that it is a test to determine whether
an investigational product can be proven to be a safe
and effective treatment.

FACT: The very individuals who want an excessive

amount of safe guards imposed, have very much
benefitted from the clinical research process and the
efforts of volunteers anytime they take a medicine or
receive treatment from their physician.

FACT: There is no statistical evidence to support that

Indian citizens are being used as the worlds guinea
pigs, as is often proposed by the press and uninformed
advocacy organizations. In fact, Indias stake in the
conduct of global clinical trials is still very small: The
number of clinical trials DCGI approved in India from
2010-2012 is 1,065, while globally, during the same
period 43,325 trials were registered officially in the US;
about 2.5% of all registered studies. The opposite case
is more likely, given that most of the marketed
medicines available in India were innovated and tested
elsewhere.

FACT: A statistic widely reported in the press, often not

explained fully, has led to a massive wave of
condemnation and public discourse. Specifically, the
data that 2,868 people died during clinical trials of 475
new drugs between 2005 and 2012 is very misleading
and purposely so it sells newspaper and attracts
website visitors. The fact is, out of the estimated
451,000 people who participated in clinical trials
between 2005 and 2012, 89 died of trial related causes.
All other cases of death reported, represent individuals
who died of something else while participating in the
trial. If those people were injured or became ill during
the trial for example, a person in a cancer trial falls in
an accident at home and dies they are recorded as a

Serious Adverse Event (SAE) and officially tracked and

reported as part of the data package associated with a
new drug application. Therefore, 2,868 of the people
reported in the news to have died during a clinical trial
died from something that was determined NOT to be
caused by the study drug or trial related procedures.
India has 1.2B people, more than 15% of the worlds
population, while burdened with >22% of cases of
disease. So, statistics prove that during a 7 year span,
89 people out of 1.2B died from their participation in
research - research meant to advance treatments
designed to improve or save lives. While ANY loss of life
is regrettable and steps should be taken to prevent
such loss, there is by no means a greater risk of safety
issues occurring in India, than there is any other part of
world where the human race is working to advance
science and save lives. The deaths in clinical trials are
not unique to India. The trials in which India
participated had SAEs and deaths reported from other
parts of the world.

FACT: In all of 2013, 9 global clinical trials were

approved for conduct in India. Essentially, there has
been no advancement of treatments toward approval in
India for nearly a year due to widespread overreaction
and fear. Have people been saved or are we actually
losing thousands of lives as a result of this stoppage?

FACT: Indias Good Clinical Practice standards which

outline the processes for the conduct of clinical trials
are more stringent than those followed by the
international community, including leading clinical
research countries in the North America, Western
Europe, Japan, Australia and elsewhere titled called
the International Counsel on Harmonization Good
Clinical Practice or ICH-GCP.

FACT: Recent legislation requires compensation paid to

clinical trial volunteers who do not receive the intended
therapeutic effect of the investigational drug, or who
receive a placebo (sugar pill) instead of the
investigational drug. These two requirements are
exotic, cannot be found in any other part of the world
where clinical research exists, and strike right at the
heart of the very point of conducting clinical trials. First,
clinical trials are tests of investigational medicines so
the very point of the trial is to see if the treatment has
the intended effect. Second, to determine whether the
treatment is actually working or if its 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 group results. Volunteers
are explained these things as part of the informed
consent process before they even agree to participate
in the study.

FACT: The Supreme Court is mandating the use of

audio and visual recordings of the consent process that
each clinical trial volunteer must go through when
deciding to participate in the trial. This is another
unprecedented step not found in normal Good Clinical
Practice anywhere in the world, whether established or
emerging market. The time, costs and logistics of
implementing such a measure will further slow the
clinical research process and create unnecessary delays
in the advancement of potential new treatments to the
patient population of India. The recommended process
also does not take into account the two major ground
realities of medical care in India.

FACT: The patient-doctor relationship in India is very

strongly based on faith. This A-V process will
introduce an element of distrust and discomfort in that
relationship. Instead of encouraging real discussion on
health and treatment between the doctor and the
patient, it will only disengage the two parties.

FACT: A major proportion of the Indian population

culturally still protects the female gender in a purdah
system. How will we deal with this cultural issue in the
light of the ease of electronic transmission of data in
this technological age. Who will protect their privacy?

FACT: The review process that new clinical trial

applications go through in India is as rigorous, if not
more rigorous than, most other countries across the
world, even those that have been conducting trials for
many decades. The past 5 years have seen the
implementation of a number of new regulations and
strict requirements aimed at tightening the review
process after some earlier incidents. The resulting two
step process which has been in place for nearly two
years now, ensures that all new trial applications not
only undergo the scrutiny of the office of the Drugs
Controller General India - but due to legislative changes
in 2010 - also now undergo an in-depth evaluation by a
panel of 10 objective physicians, who have extensive
expertise in the therapeutic area/disease being
targeted by the clinical trial. Only after passing
successfully through these two layers and then being
approved by independent ethics committees located at
each research center, can the trial actually proceed.
Other Truths about Clinical Research
- Clinical trials in India are regulated by a set of rules
that are in conformity with and in some cases surpass
- global standards
- The implementation of present set of rules must be
closely monitored before moving the goal post
- Clinical research when properly conducted has a great
potential to help us understand the prevalence of
various diseases and help us to more effectively

prevent, diagnose, treat and rehabilitate the affected

population
- Clinical research has provided medical access to
thousands of patients since the policy change in 2005
- Since 2005, clinical research has generated
employment to thousands of professionals and has the
capacity to generate employment to a few hundred
thousands of such professionals
- Clinical research has contributed significantly to the
growth of laboratories, imaging, logistical support and
other services

Supporters
Reasons for signing

Most Popular

Latest

Mahesh Dega

INDIA

about 23 hours ago

Liked 13

It is really the sluggishness that NGO and Supreme

Court are only focusing on problem." Banning Clinical
Trials in India " is not a solution. SC, NGO and Media
dont have knowledge about clinical trials. On the other
hand, the deaths due to tobacco products is still the
major cause in India has not been banned, but clinical
trials which causes known deaths, is targeted to be
banned. 50% of global clinical trials are conducting in
USA and it doesnt mean that USA government using
their citizens as guinea pigs.

Pramesh Shanmugham

1 day ago

Liked 6

INDIA

As a cancer surgeron and clinical researcher, I feel that

the process of scientific progress and biomedical
research is critical to improve the health of our
population. All of us who practice medicine know that it
is an inexact science with a large number of
unanswered questions and unknown facts. Clinical and
translational research are vital for these gaps in
knowledge to be filled. The fact that we live longer
today than we did as recently as 20 years back is
primarily because of the progress made in clinical
research - both by industry and academic researchers.
As it is, India has lagged grossly behind developed
countries in biomedical research; at a time when Indian
researchers are getting their act together and
proposing high quality research embedded strongly
with the principles of bioethics, it seems cruel to put
unfair obstacles in their path. While regulation is
important and welcome, they also need to be rational
and logical. What is needed now is effective
implementation of existing rules and not knee-jerk
reactions and the introduction of new, restrictive and
unethical laws. There is an urgent need to establish a
fair regulatory environment which facilitates and
promotes the conduct of high quality biomedical
research in the country.

PRITAM HAZRA
1 day ago

INDIA

Liked 4

Clinical Trial is the only way to bring novel molecules or

alternate treatment options in our healthcare system.
Nobody can't deny it's important. We are lagging
behind dude to the present regulatory environment in
the country. Every coin has two side. We can't ignore
the importance just for few separate incidence.
Changes are always welcome since clinical trial is
directly related to our health but it is not the proper
way our judiciary system is making the changes. We
have already wasted approximately 2 years now it is
the time to materialized everything at earliest.

Tapankumar Shah

SINGAPORE, SINGAPORE

about 21 hours ago

Liked 3

Who are guinea pigs? The ones who take drugs that
have never been tested in India before OR those who
participate in clinical trials and are treated with respect,
and extremely well taken care of? The patients who
participate in clinical trials are NOT treated like guinea
pigs. They are treated as great human beings who
support advancement of medical science for the
greater good of the society, for the good of millions of
patients who suffer from the diseases that they do.

Clinical trials are not an income for the pharmaceutical

industry. They are rather an expenditure and a heavy
one. They spend crores of rupees to ensure that the
trials are conducted ethically, and overseen by well
qualified monitors who personally go to the trial sites
and verify data to confirm that the rights, safety, and
well being of patients are maintained, and that the data
generated are cridible for extrapolation to the larger
population of the country, and the world. Clinical trials
are not optional; in fact, there is no other option. For
the pharmaceutical industry, doing clinical trials is the
only way to prove that the drugs are safe and effective
and only on the basis of clinical trials are the drugs
approved in each country by the health authorities after
thorough evaluation.
Please do not let anyone misguide you. Read,
understand, consult experts and then take your
decision. Do not keep quiet because you may suffer
from a disease for which you don't have a treatment in
India only because clinical trials on that drug were not
performed in India. It is truly a question of your life.

Rameshwar Gaur

INDIA

about 24 hours ago

Liked 3

Because I used this type for my treatment

Because I used this type for my treatment

POOJA RASTOGI

INDIA

about 15 hours ago

Liked 2

Research is an important aspect of further development

and progress in every arena of life. We cannot halt
research because of few people who are not well
informed or wrongly informed. Indian research caters to
a huge population with different ethnicity. Not doing
clinical research in India is like jeopardizing the future
generations to health/drug hazards which some people
are not even able to anticipate. So I feel clinical
research must get a GO ON! Also my eight year old son
feels that clinical research is very important because he
does not want to see sick people in his country. Wake
up people!

Alex Peter

GANDHINAGAR, INDIA

about 16 hours ago

Liked 2

Clinical Research has a great social purpose- to find

more effective medicine and treatment procedure for
mankind . No short cut to avoid the clinical research .No
clinical research means new medicine. That is against

the right to life of the patient. When standard of care

fails , the patients who have life threatening diseases,
desperately searching for the research medicine as a
last resort. In several times. it does miracles.
Clinical research comes first. Clinical practice comes
second. Without clinical research, Clinical practice will
be stagnated soon.
Clinical research and practice should go hand in hand.
Clinical Research regulation and monitoring should be a
continuous process for a conductive environment .
Anybody can imagine to stop the clinical practice to
avoid the clinical injuries?
Every effective medicine and treatment save the life of
the millions .
In India, thousands of patients life expectancy and
quality of life improved to a great extent because of the
clinical research .
we are expecting a more balanced and industry
informed order from supreme court soon.

Virender Sangwan

HYDERABAD, INDIA

about 16 hours ago

Liked 2

I have active clinical trial research doctor and

practioner. Not doing trials is great disadvantage to us
and to our patients and society at large.

Prem Pais

BANGALORE, INDIA

about 17 hours ago

Liked 2

Clinical trials are essential for discovery of new

treatments for the Indian people

Bhavani Veeravalli

INDIA

about 18 hours ago

Liked 2

My mother suffers from Parkinson's Disease to which

cure can be found only if clinical trials are conducted
non stop. Govt should not stop clinical trials as this
could mean loss of lives due to lack of life saving drugs
coming into the country!

could mean loss of lives due to lack of life saving

drugs coming into the country!
Tapankumar Shah

SINGAPORE, SINGAPORE

about 23 hours ago

Liked 2

Who are we punishing by stopping clinical trials in

India? The microscopic minority of people who may not
have done clinical trials well or the people of India who
need newer treatment options?

neha chandan

MUMBAI, UNITED STATES

about 24 hours ago

Liked 2

As of now this is the finacial loss for the country and

clinical research professionals, but gradually we will see
that this will be the human loss since there will be no
new medicine available. Human loss will become more
impacting than financial loss. Let us see the long term
perspective & avoid human losses/deaths due to this.

Viraj Suvarna

1 day ago

Liked 2

INDIA

Patients are safer within the controlled, highly regulated

environment of good quality, ethical, and compliant
clinical research practice. Only if the benefit to risk ratio
is positive would a person be asked by his doctor if he
wishes to be a part of a clinical trial. It is only after he is
informed and has fully understood would he consent of

his own free will to participate. He can withdraw

consent at any time without suffering any adverse
consequence or having to give any reason. He will be
treated free of cost for any adverse event that may
happen during and due to the clinical trial. When
indicated compensation will also be done. Careful
selection of the right investigator, rigorous training, and
close monitoring, audits, and inspections are done.
Only if regulatory and ethics committee approval
happens, can a trial begin. Over the years, patients
have been made safe for CR. It's time to now save CR,
for patients.

Mohit Mehrotra

LISLE, IL

about 14 hours ago

Liked 1

It is critical for advancement of new treatments for

patients in India which has about 15% of the worlds
population and over 20% of the disease burden. For
India to grow in importance, it must be place where
science and research is encouraged and flourishes like
the US and other modern progressive countries.
Without good research patients in India will suffer in the
long term.

Dr. Jayendra Duorah

INDIA

about 19 hours ago

Liked 1

In the long run we will suffer since companies would

refuse to launch new products in India. We are
behaving as we the only super power in world. we need
to retrospect and think what we have contribute till
date to the world except the size of the pupulation

Ravitej R

INDIA

about 19 hours ago

Liked 1

Because I oppose this misconception of "Using our

fellow Indians as Guinea pigs". Somewhere I heard that
in India Clinical Research Industry is the highly
regulated industry after Airlines Industry. That itself
says about it. As mentioned in this petition many a
times our regulations surpasses international standards
and in each every step of the research we have to
undergo rigorous quality checks and everything needs
to be documented within stringent timelines. Every
step of the conduct is followed as per standard
procedures, policies, protocol which have sound
scientific back ground etc etc..in order make sure the
regulatory compliance. And in turn main objectives of
regulations are safety and well being of subjects.
Moreover because of this stagnancy there are
implications we are noticing in terms of business and

employment in this sector. The need of an hour is

effective implementations and regular checks rather
halting the entire process.

Dr. Prafulla Patil

INDIA

about 19 hours ago

Liked 1

As it is unnecessarily affecting scientific advancement

and the progress of the country.

ruhi rupam

INDIA

about 20 hours ago

Liked 1

New treatment are not available in market without the

first undergoing a lab, a preclinical trial and clinical trial
so clinical research and clinical trial is most important .

Mustafa Pardiwala

INDIA

about 20 hours ago

Liked 1

For growth of Clinical Trail Industry in India

Chandana Pal

HYDERABAD, INDIA

about 21 hours ago

Liked 1

India with its huge population and vast pool of

diseased, needs an ever emerging range of drugs and
therapies. This could be possible only when the clinical
research industry works in tandem with the societal
need. We had started with a great promise but
somehow lost the momentum mid way through as this
industry was singularly taken for media inspection and
sympathy garnering. The highs attained were
beautifully blinded by the lows depicted by the media.
The industry came to a grinding halt almost 3 years
back and today, a country which was showing a great
promise in an upcoming industry is trying to find a
footing again. For the benefit of the society at large and
the industry which caters to health and well being, it is
high time we start the process of getting and doing
research trials again . The changes in the policies and
the administration can go on hand in hand while the
clinical trial processes resume.