Clinical Trials in India - Wikipedia

Clinical trials in
India
Clinical trials in India refers to clinical

research in India in which researchers test
drugs and other treatments on research
participants. NDCTR 2019 and section
3.7.1 to 3.7.3 of ICMR guidelines[1]
requires that all researchers conducting a
clinical trial must publicly document it in
the Clinical Trials Registry - India.[2]
Flowchart of Clinical Trials in India
Various government agencies and laws

regulate clinical trials. The Drugs
Controller General of India grants approval
for clinical trials and is the top level
authority which specifically oversees
clinical trials.[3] The Drugs Controller is a
part of the Central Drugs Standard Control
Organisation and answers to that
organization.[3] Both of those
organizations answer the Ministry of
Health and Family Welfare as the highest
level government agency overseeing
everything related to medicine and
health.[3] The Indian Council of Medical
Research governs the professional and
ethical behavior of the doctors and
scientists. The Pharmacovigilance
Program of India tracks reports of harm
from the use of drugs. Outside of the
central government, each state has its own
regional regulatory agencies with some
input into governing trials.
Since the early 2000s there have been

international discussions from science,
medicine, and business sectors which
observed that India is both an attractive
and challenging place to conduct medical
research.[4] Favorable characteristics of
India included that there are many trained
workers including health professionals,
there is a large and diverse population, and
that the cost of research is relatively low in
India in comparison to other countries
capable of doing research.[4] Challenging
characteristics include lack of research
capacity, evolving and uncertain
government regulatory infrastructure,
diversity of languages, and the need for a
culture of research participant
confidentiality.[4]
In the years around 2010 there were
various scandals in media and popular
discussion in which companies conducted
clinical trials in unethical ways. There were
many discussions raising many
complaints, including that researchers
were not getting informed consent from
research participants, and that the medical
research was dismissing high rates of
injury and death among research
participants. Following the 2013 case
Swasthya Adhikar Manch v. Union of India
in the Supreme Court of India, various
government agencies reformed their
regulations to make clinical trials more
ethical.[5] There have been many changes
with various responses. Among the
responses, some say that the clinical trials
are safer for participants, and others say
that the new rules favor large domestic
and international companies over other
stakeholders.
Government regulation
Since 2009 the Central Drugs Standard
Control Organization has mandated that
anyone conducting clinical research in
India must preregister in the Clinical Trials
Registry – India before enrolling any
research participants.[6]
Various government agencies and laws
regulate clinical trials. The Drugs
Controller General of India grants approval
for clinical trials and is the top level
authority which specifically oversees
clinical trials.[3] The Drugs Controller is a
part of the Central Drugs Standard Control
Organisation and answers to that
organization.[3] Both of those
organizations answer the Ministry of
Health and Family Welfare as the highest
level government agency overseeing
everything related to medicine and
health.[3] The Indian Council of Medical
Research governs the professional and
ethical behavior of the doctors and
scientists. The Pharmacovigilance
Program of India tracks reports of harm
from the use of drugs.[7]
Before 2005 India had a "phase lag" policy

for clinical trials from foreign countries.[8]
In this policy, all clinical research in India
had to begin at phase one.[8] A 2005
change to liberalize the policy begin
allowing companies to skip earlier phase
trials to start with more risky trials in India,
if there was prior research doing those
earlier trials in another country.[8]
Clinical trials have to be monitored by an

ethics committee which registers with the
government.[9] A study examining all
registered ethics committees in 2017
reported that few of them were in
academic medical institutions, which is the
global norm and desirable for such
organizations.[9]
Some legal commentators describe how

the Constitution of India provides
fundamental rights in India which apply to
participants in clinical trials.[10]
Overview of trials
Various reports have discussed the
number of clinical trials which the Indian
government has approved per year.[11] A
theme of these reports is that the number
of trials generally increases, and that
changes in the rates of the number of trials
approved corresponds with regulatory
changes.[11][12][13]
Count of clinical trial approvals [12]

Year Trials
2008 65
2009 391
2010 500
2011 262
The government approval process for

clinical trials is sporadic. A 2013 report
commented that in one day, the Indian
government approved 50 trials after not
having approved any in the past six
months.[12] The same report noted that the
rate of government approval changes by
year.[12]
A single study examining a sample of

academic papers which reported the
results of dentistry-related clinical trials in
2011-12 found that the reporting was
poor.[14]
Ethics
Various commentators have noted that
there is a conflict between the opportunity
for business investors to conduct research
in India and the rights and safety of the
volunteer research participants who
participate in these clinical trials.[15]
Discussions of this issue often propose
some kind of balance where researchers
do trials, but not too many or too quickly,
and that the trials collectively support
ethical and safety practices which
community stakeholders, academic
researchers, doctors, and the government
all create together.[15]
Wealthy companies in countries with

strong economies routinely seek to
purchase clinical trial research in India as
they seek comparable results at lower
cost.[16] As the wealthy country has the
power of its money, and as typical
participants in clinical trials are volunteers
with no understanding of the money
involved or power dynamics, many ethical
issues arise.[16]
A 2018 study on informed consent found

that in a set of cancer-related trials, nearly
all research participants had serious
misconceptions about their research
participation.[17] A common misconception
was an expectation of improved health
care.[17] The study recommended
improved research participant education
as a way to make the management of
trials more ethical.[17]
Government talks of permitting human
challenge studies in India began in
2017.[18] The Translational Health Science
and Technology Institute expressed
support for allowing these trials at that
time.[18]
One 2015 audit of 5 years of trials at a

single site found that the expected
percentage of people invited to participate
declined to do so.[19] That study said that
this rate of refusal was an indication of an
appropriate level of persuasiveness in
study participant recruitment.[19]
An evaluation of about 50 clinical trials in
2007-08 found that the reported results
had higher than expected rates of false
positive errors due to the statistical
methods the researchers used.[20]
Comparison to other
countries
India's clinical research is a subject of
comparison with that of China,[16][4][21]
countries in Africa,[22][23] and countries
with similarly sized economies.[16] India is
both an attractive and challenging place
for both Indian and foreign clinical
research for various reasons.[4]
A common motivation for foreign
companies doing research in India is
relatively lower cost in as compared to
comparable research elsewhere.[4][24] India
was a single nation with a large, diverse
population.[24] Many potential research
participants in India had not previously had
medical treatment, and clinical trials get
better data from such people.[24] India also
has a well trained workforce and many
research sites which met international
good clinical practice standards.[24] India's
national health system provides a lot of
care in large urban hospitals.[4] This
centralization is also favorable to
conducting research.[4]
One challenge to doing research is a
shortage of research sites which could
conduct research and expand the sector.[4]
This shortage has various causes,
including lack of educational programmes
leading health professionals into research
as a career track, the lack of experienced
administrators who could expand study
capacity, and a national research
environment with either insufficient quality
control processes.[4]
When researchers conduct trials in

multiple countries collecting patient-
reported outcomes is useful.[25] However,
to make sense of any such reports from
India, then researchers have to adapt the
instructions for local Indian culture.[25]
A 2011 evaluation found that a sample of

clinical trials in India complied with the
Consolidated Standards of Reporting
Trials.[26]
To make India more compliant with

international standards the government
amended the Drugs and Cosmetics Rules,
1945 in 2005 and 2008.[26]
At the end of 2010 India was conducting

7% of phase III and 3% of phase II trials
globally.[26] In 2019 India was hosting
about 1% of the world's clinical trials.[27]
Social awareness
There was perception in the research

community that the media had usefully
brought public scrutiny of the ethics and
conduct of clinical trials.[24] While
researchers and investors wanted trials,
they also wanted a reliable research
environment which the public and media
could trust.[24] Various changes in
government regulation sought to make
trials safer for research participants and
investment in trials.[24] The response to
having changes in general was positive,
although there was intense debate from
stakeholders on the individual changes.[24]
The criticism tended to argue that the
changes were too strict.[24]
There was criticism that medical journals

in India were publishing the results of trials
without requiring that the articles describe
compliance with regulatory standards
including Consolidated Standards of
Reporting Trials.[26][28]
Injury
In 2013 the Supreme Court of India

ordered the Ministry of Health and Family
Welfare to police and prevent multinational
companies from conducting illegal clinical
trials in India.[29][5]
There is public information reporting how

many people die during clinical trials.[30] It
is also known that when people die during
trials in India, the trial organization rarely
pays compensation to the family of the
deceased.[30]
The research industry has formulas for

calculating how much money to pay when
someone dies in a clinical trial.[31]
Foreign influence
A 2011 paper noted that low operational

costs, improved government regulation,
and existing business infrastructure have
made India increasingly attractive as a
place for foreign companies to conduct
clinical trials.[7]
Some clinical trials based in the United

States also do research in India. A 2019
examination of 10 years of United States
children's health research found that of
about 9000 trials registered about 120 of
them also included clinical trials in
India.[32] This study found that these trials
were for health issues which actually
affect children in India, and that
consequently, the research was
appropriate for India.[32]
Some researchers study global practices

for managing clinical trials and apply
lessons learned to multiple countries at
once, with India being among them.[33][34]
When foreign companies conduct only

phase III trials in India, the researchers
conducting those trials tend to not publish
as many scientific insights as researchers
typically do in other circumstances.[35]
There is a foreign expectation that perhaps
because India has relatively less regulation
than foreign countries which export clinical
research, then perhaps the researchers in
India would have more insights.[35] The
reasons for this are not clear, but one
reason may be that researchers who
oversee the trial for longer periods and not
just the last phase tend to care more
about publishing research results.[35]
When financial investment is the priority

then foreign sponsored research tends to
focus on the health concerns of the host
country rather than the health needs of
India.[36] A characteristic of a healthy
clinical trials sector in a country is
prioritizing the most urgent health
concerns of the population.[36] Some
researchers advocate for reflection on
India's research priorities.[36]
A review of clinical trials from 2006 to

2013 foundation that when India hosted
clinical research for either the United
States or European Union, and when
research in India led to the availability of a
new drug in those places, then in 40% of
cases India did not also get domestic
approval to use that drug.[22] This low rate
of domestic drug approval demonstrates
that the research is not actually a medical
benefit to the local population in India.[22]
More frequent drug approvals for drugs
tested in India and approved elsewhere
would be a public benefit.[22]
Business
Various reports describe the global

industry of outsourcing clinical research
from one country to another, and present
India as one of the lower cost countries for
conducting trials.[37]
A 2007 paper reported that in the past few

years the annual revenue of the clinical
trials industry had grown 25% annually.[38]
Companies conducting clinical trials in
India often do so through a contract
research organization.[39] Since the 2000s
there has been recognition that India is an
attractive place to grow an industry of
drug research.[39]
A 2008 report described the entry of

multinational companies into India for
clinical trials research as a frenzy.[40] At
the time there was a perception that the
industry was going to grow fast for the
foreseeable future in a way that favored
the research investor.[40] Most investors
wished into enter India through contract
research organizations.[40]
Foreign investment in India has resulted in
a concentration of international research
centers in India.[41] Larger research
companies are growing faster than small
ones, and larger ones are capturing the
influence to propose government
regulations more quickly than other
stakeholder groups.[41] The investment
from foreign companies has resulted in
more education, professional training, and
jobs in the clinical research sector.[41]
However, there has been an obvious
sudden increase of influence by both
foreign and domestic large companies as
this research field has developed.[41]
The establishment of the
Pharmacovigilance Program made India a
more attractive international destination
for foreign companies to bring clinical
trials research.[7]
History
Until 1995 the United States, Europe, and
Japan conducted most clinical trials.[42]
The first evaluation of good clinical
practices for research in India was done in
1995.[43] A 2004 paper advised that India
lacked the research environment which
most clinical researchers require.[44]
Because of the risks, that paper advised
that foreign countries would not gain
benefit from outsourcing clinical trials to
India.[44]
2005 to 2013
India agreed to comply with the TRIPS

Agreement in 2005.[45] The agreement
changed the way India recognizes
intellectual property and changed the
research environment in way that enabled
foreign companies to conduct clinical
trials in India.[45][46] Foreign contract
research organizations were able to
conduct clinical trials in India from this
point.[41]
An estimate in 2007 predicted that India
would be conducting about 20% of the
world's clinical trials by 2010.[42] Further
speculation of the time was that India
would be the preferred global destination
for many sorts of clinical trials.[47] Among
all that growth, a major concern was
establishing regulation to improve the
ethics and integrity of clinical research in
India.[42] The Indian Council of Medical
Research established the Clinical Trials
Registry - India in July 2007 with the intent
to improve India's clinical trials research
environment.[6]
In 2008 a representative for the Indian
Council of Medical Research remarked
that increased government regulation
would be necessary to ensure research
integrity and public safety in clinical
trials.[48] In 2008 a group of Indian medical
journals made a pledge that from 2010
onward, they would only publish research
on clinical trials if that trial was
appropriately registered.[49][48] Prior to this,
there were essays considering whether the
time was right to do this.[50]
In 2009 there was a significant expansion

in clinical trials done in India.[13] Beginning
in 2013 there were many regulatory
changes which had the effect of reducing
the number of clinical trials while also
drawing attention to ethical challenges of
clinical research in India.[13]
In May 2012 the 59th report of the Indian

Parliamentary Standing Committee on
Health and Family Welfare issued a report
criticized the Central Drugs Standard
Control Organization. The report
complained that the organization was
underfunded and understaffed.[51]
Because of lack of staff, the organization
would never be able to perform its
duties.[51] The staff who were there were
working under a misguided mandate to
"meet the aspirations … demands and
requirements of the pharmaceutical
industry", which was an error and a conflict
of interest against protecting the health of
the public.[51] Another problem that the
report identified was that although India
requires drug companies to conduct at
least phase III trials in India if other
countries have already approved the drug,
for some undocumented reason, the Drugs
Controller was granting approvals without
this research.[51] Also, in 3 cases, drugs
which neither had approval in other
countries nor trials in India got approval
for undocumented reasons.[51]
2013 to 2019
By 2013 the problems with clinical trials

had become troublesome to the point of
media and public attention.[52] When the
media criticized trials, those reports
tended to say that the researchers were
exploiting the research participants by
treating them as experimental guinea
pigs.[24] The media attention and public
discussion resulted in researchers
conducting fewer trails.[24] The number of
trials went from 529 in 2010, to about 250
in 2012, to about 100 in 2013.[24]
The response to this was that various
government agencies organized regulatory
changes to resolve many problems at
once.[52][53] Researchers reflected on the
causes of the problems, and the necessary
changes to prevent future problems, and
the regulatory reform which would support
the changes in science and industry.[52][53]
One change was that the government

named a list of responsibilities and divided
among the ethics committee, the
investigator, and the sponsor.[53] This way,
each of those agents in a clinical trial take
responsibility for their parts.[53] From this
point the researchers must register all
clinical trials into the Clinical Trials
Registry - India.[24] Another change was
that ethics committees associated with
clinical trials had to themselves register
with the Drugs Controller General of
India.[24] The informed consent process
had to include all information both in the
text document and a verbal
description.[24][53] No principal investigator
can oversee more than three trials at
once.[24] Anyone funding a principal
investigator has to disclose to the
government how much they are paying.[24]
The government regulator set up audit
process for ethics committees.[24] The
researchers must report serious adverse
events quickly to the study sponsor, the
ethics committee, and the government
regulator.[24][53] All trials will comply with
publicly available payment formulas for
calculating how much money to give in
case of someone dying or experiencing
any other serious adverse effect.[24][53]
In the informed consent process there

were was consensus for addressing some
communication issues.[24] One was
explaining that the control group in a
placebo-controlled study will get no
treatment.[24] Another was explaining that
the drug candidate is experimental, and
not necessarily an effective therapy.[24]
There was also recognition that many
administrative, procedural, and reporting
functions needed national
standardization.[24]
In 2018 the government established a

process for approving drugs in India,
without clinical trials, in exceptional
circumstances such as an epidemic.[54]
2019—present
In 2019 the government enacted the New

drugs and clinical trials rules 2019.[55]
These rules provided more guidance for
how the ethics committee of a clinical trial
should oversee it.[55] Critics of the rules
said that the government compromised
public safety in favor of industry and
financial interests.[56]
Special populations
When Indian people consider volunteering
for clinical trials they frequently have the
same reasons for either joining or
declining.[57] Motivations for joining include
intent to gain health benefit, altruism, in
respect of the request of their physician, to
get money for participating, and to get an
opportunity to learn more about health and
research.[57] Reasons for not wanting to
participate in a trial include mistrust of the
organizations managing the research, fear
of trial risks, stress, the obligation of
participating, fear that the trial will not
respect their personal information,
creating a burden on their friends and
families to support them in the trial, and
the lack of available information about the
research in their own local language.[57]
People with schizophrenia require specific

cultural support to participate in clinical
trials.[58]
A 2009 report described how innovation in

phase 1 cancer research trials could have
a big impact on Indian health.[59]
Various studies in the United Kingdom
have described how British researchers
can make trial participation easier for
South Asian people living in the UK.[60][61]
A 2011 report encouraged teaching clinical

research in the curriculum of medical
students to prepare them to conduct
trials.[62]
A 2019 survey found that respondents in

India were cautious in saying that they
would approve of clinical trials related to
the sexual health of adolescent girls.[23]
See also
Clinical trials on Ayurveda
Healthcare in India
Health in India
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Further consideration
Indian Council of Medical Research
(2017). "National Ethical Guidelines for
Biomedical and Health Research
involving Human Participants" (https://m
ain.icmr.nic.in/sites/default/files/guideli
nes/ICMR_Ethical_Guidelines_2017.pd
f) (PDF). Indian Council of Medical
Research.
"Extraordinary" (https://cdsco.gov.in/ope
ncms/export/sites/CDSCO_WEB/Pdf-do
cuments/NewDrugs_CTRules_2019.pd
f) (PDF), The Gazette of India (in Hindi
and English), New Delhi: Ministry of
Housing and Urban Affairs, 19 March
2019
External links
Clinical Trials Registry - India (http://ctri.
nic.in/Clinicaltrials/login.php)
Retrieved from
"https://en.wikipedia.org/w/index.php?
title=Clinical_trials_in_India&oldid=1170913883"
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Clinical trials in

Clinical trials in India refers to clinical

Various government agencies and laws

Since the early 2000s there have been

Before 2005 India had a "phase lag" policy

Clinical trials have to be monitored by an

Some legal commentators describe how

Count of clinical trial approvals [12]

The government approval process for

A single study examining a sample of

Wealthy companies in countries with

A 2018 study on informed consent found

One 2015 audit of 5 years of trials at a

When researchers conduct trials in

A 2011 evaluation found that a sample of

To make India more compliant with

At the end of 2010 India was conducting

There was perception in the research

There was criticism that medical journals

In 2013 the Supreme Court of India

There is public information reporting how

The research industry has formulas for

A 2011 paper noted that low operational

Some clinical trials based in the United

Some researchers study global practices

When foreign companies conduct only

When financial investment is the priority

A review of clinical trials from 2006 to

Various reports describe the global

A 2007 paper reported that in the past few

A 2008 report described the entry of

India agreed to comply with the TRIPS

In 2009 there was a significant expansion

In May 2012 the 59th report of the Indian

By 2013 the problems with clinical trials

One change was that the government

In the informed consent process there

In 2018 the government established a

In 2019 the government enacted the New

People with schizophrenia require specific

A 2009 report described how innovation in

A 2011 report encouraged teaching clinical

A 2019 survey found that respondents in

This page was last edited on 17 August 2023, at

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