Good Clinical Practices: An Indian Perspective

Abstract

Clinical research is a mechanism or a process that provides concrete evidence that new treatments or remedies
suggested are safe and effective. The ultimate aim of clinical research is the identification and discovery of
contemporary diagnostic methods as well as the establishment of advanced standards of therapy. Good clinical
practice (GCP) is an ethical and scientific quality standard for designing, conducting and recording trials that
involve the participation of human subjects. Acquiescence with the guideline gives a pledge to the public that the
morality, integrity and welfare of humans participating in the trials are protected. India offers distinctive
opportunities for performing clinical trials with large patient population, experienced and well-equipped
investigators and leading medical institutions with low patient trial cost when compared to the regulated nations.
However, to ensure a uniform standard of clinical research in the entire nation and to provide data for
registration for new drugs before use in human population in India, there was a need for our own Indian
Guidelines. GCP guidelines were developed by an accomplished committee set up by CDSCO along with the
clinical experts. This article elucidates the significance of Good Clinical Practice from an Indian Clinical
Research perspective, whilst defining and outlining the goals and objectives of GCP. It addresses the historical
events that led to the emergence of Good Clinical Practices and examines the current scenario with regards to the
application of GCP in Clinical trials in India. Finally, the article analyses the challenges faced with regards to
maintaining an evidential and competitive system and also suggest a way forward for further enhancing the
credibility and efficiency of Good Clinical Practice in Clinical Research.

Full text

Research J. Pharm. and Tech. 11(7): July 2018
3209
ISSN 0974-3618 (Print) www.rjptonline.org
0974-360X (Online)
REVIEW ARTICLE
Good Clinical Practices: An Indian Perspective
Lovely Joylen Castelino, Anoop Narayanan V*, Swapnil Dylan Fernandes, Pankaj Kumar,
Sandeep D S.
NGSM Institute of Pharmaceutical Sciences, NITTE Deemed to be University, Mangalore, Karnataka, INDIA,
575018
*Corresponding Author E-mail: anoopvn84@gmail.com
ABSTRACT:
Clinical research is a mechanism or a process that provides concrete evidence that new treatments or remedies
suggested are safe and effective. The ultimate aim of clinical research is the identification and discovery of
contemporary diagnostic methods as well as the establishment of advanced standards of therapy. Good clinical
practice (GCP) is an ethical and scientific quality standard for designing, conducting and recording trials that
involve the participation of human subjects. Acquiescence with the guideline gives a pledge to the public that the
morality, integrity and welfare of humans participating in the trials are protected. India offers distinctive
opportunities for performing clinical trials with large patient population, experienced and well-equipped
investigators and leading medical institutions with low patient trial cost when compared to the regulated nations.
However, to ensure a uniform standard of clinical research in the entire nation and to provide data for
registration for new drugs before use in human population in India, there was a need for our own Indian
Guidelines. GCP guidelines were developed by an accomplished committee set up by CDSCO along with the
clinical experts. This article elucidates the significance of Good Clinical Practice from an Indian Clinical
Research perspective, whilst defining and outlining the goals and objectives of GCP. It addresses the historical
events that led to the emergence of Good Clinical Practices and examines the current scenario with regards to the
application of GCP in Clinical trials in India. Finally, the article analyses the challenges faced with regards to
maintaining an evidential and competitive system and also suggest a way forward for further enhancing the
credibility and efficiency of Good Clinical Practice in Clinical Research.
KEYWORDS: Good Clinical Practices, CDSCO, Clinical Research, Human Experimentation, ICMR,
Guidelines, Clinical trial.
1. INTRODUCTION:
Good clinical practice (GCP) is an internationally
accepted ethical, scientific quality standard, used to
design, conduct, record and report clinical trials that
involve the participation of human subjects. It
encompasses all aspects and facets of clinical trials, i.e.
from the stage when the trials are initiated, right up to
the stage where the clinical trial results are reported.
Received on 07.02.2018 Modified on 26.03.2018
Accepted on 18.04.2018 © RJPT All right reserved
Research J. Pharm. and Tech 2018; 11(7): 3209-3215.
DOI: 10.5958/0974-360X.2018.00590.5
Compliance with these principles provides assurance
that the rights, safety and well-being of subjects
participating in clinical trials are protected, and the data
generated from the clinical trials are credible.1 GCP
statute dates to one of the oldest traditions in medicine,
The Hippocratic Oath, which is primarily known for its
principle to cause no harm to the subject. However,
modern medical research requires a more efficient set of
guidelines to facilitate a healthcare professionals ethical
as well as scientific responsibilities while involved in
drug development and research.2 Hence, GCP is a key
requirement for personnel involved in the conduct of
clinical studies and can be termed as a standard to which
all research is conducted. The most fundamental
ideology of GCP is that in research on human beings,
the interest of science and the society as a collective

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should never take priority over the well-being of the
subject involved in the study. Hence, it is considered
necessary to conduct clinical trials per international
council for harmonization, ICH/WHO clinical practice
standards.3,4
The two most prime tenets set down by the GCP
guidelines are;5
• Protection of Human Subjects
• Authenticity and Reliability of the biomedical data
produced.
These guidelines are purposed and aimed at ensuring
that the clinical studies are ethically and scientifically
secure and sound and that the properties of the drug or
pharmaceutical substance under exploration are properly
documented.
While GCP was only a recommendation in commercial
studies at the time it was introduced, over the years, the
importance of GCP has risen significantly and on1stMay
2004, an EU Directive became applicable in Danish
Law, which stated that GCP was no longer a mere
recommendation but a legitimate requirement when
carrying out clinical trials on new drugs and medical
products.6 Clinical trials for medical devices, after this
directive, were required to follow the ISO Standard:
DS/EN 14 155 which is found to be equivalent to GCP
for medical devices.
1.1. Advantages of GCP:
GCP has ensured that clinical studies conducted in
different regions of the world are identical, by
prescribing uniform standards for planning, conducting
and reporting the studies. It has secured the privacy of
subjects and has also protected the confidentiality of the
biomedical data generated. The guidelines assure the
public that the trials subjects are being treated with
dignity and respect and that the wellbeing of the subjects
outweighs the interests of the study itself. This has
further helped motivate and encourage people to take
part in clinical studies, without which the clinical studies
could not have been initiated.
The GCP guidelines guarantee that the quality standards,
followed at various trial conducting centers, are the
same and that the results generated can extend an
application to patients, irrespective of their gender, race
etc.The establishment and acceptance of GCP guidelines
have sent out a strong message to sponsors and
investigators initiating new clinical trials to refrain from
malpractices and misconduct, as such instances are
likely to be detected rather quickly.7
From the view point of the drug development process,
the enactment of GCP has resulted in reduced costs for
pharmaceutical companies during drug development,
which in turn has resulted in reduced costs for the
healthcare fraternity.
2. HISTORY OF GCP:
It may be essential to comprehend the background of the
development of the ICH-GCP principles. The present
form of GCP has evolved through various revisions and
amendments happened over a century, as discussed
below.
2.1. The Federal Food and Drugs Act, 1906:
The motive of this act was preventing the manufacture,
sale or distribution of adulterated or misbranded food or
drugs. Although, the act was deemed as inoperative
because of a fallacious declaration which was made
regarding the drug by the manufacturer were held not to
be mislabelled by the court, the act was not expanded to
cosmetics and it was not given the authority to prohibit
the use of hazardous drugs.8
2.2. Sulphanilamide Tragedy, 1937:
Sulphanilamide, it was a drug which was used to treat
streptococcal infections, was seen to have a therapeutic
effect and was safely used for a short period in the form
of tablet or powder. Various scientific investigations
proved that sulphanilamide would dissolve in diethylene
glycol. It was found acceptable after the company
control lab carried out trials on the mixture for flavour,
appearance and fragrance and later the product was
marketed as “Elixir of Sulphanilamide”. Instantly, the
company formulated large quantities of elixir and sent
shipments to all over the nations. The elixir which was
newly compounded had not been tested for its integrated
toxicity. No studies were conducted on the
pharmacological activity of the new elixir preparation
and hence because of this negligence, there was a failure
in identifying the specific feature of the solution.
Diethylene glycol, a chemical which is normally used as
an antifreeze, deemed to be lethal, killing more than
100 people around 15 states after using a drug that was
clearly unsafe.
This incident led to the enactment of food, Drugs and
Cosmetic Act1938 , which increased the authority to
regulate drugs.8
2.3. The Nuremberg Code, 1947:
It was designed because of the unethical and dreadful
experiments which were performed on living person
during the World War II at the Nazi war camps by the
German scientist. Nuremberg code established the need
for informed consent and clearly designed scientific
experiments for the benefit of human participants
allowing them to withdraw from the experiment at any
time.9

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2.4. Thalidomide Disaster of 1962:
Thalidomide was first marketed in 1957, in West
Germany under the trade name Contergan. In 1962, a
sleeping pill was manufactured and broadly used in
many countries, was being investigated for use in the
United States. Australian obstetrician Dr. William
McBride found that the drug could be used for treating
morning sickness in pregnant women. He started
prescribing the drug to his pregnant patients and set up a
trend. There were severe birth defects in the babies he
delivered which was probably due to the intake of the
so-called harmless compound. He later discovered that
the drug caused serious injury to the foetus when it is
taken by a pregnant woman during the first trimester of
pregnancy. Children were born without a limb or any
severe deformities.8
2.5. Declaration of Helsinki:
The world medical association, evolved declaration of
Helsinki in 1964. It formed the basic structure of the
ethical principles that fundament the ICH-GCP
guidelines which we have been practicing today. The
purpose behind the declaration of Helsinki is to provide
advice to the physicians who are engaged in clinical trial
and its focus was the responsibilities of an investigator
for the protection of rights of a human volunteer
participating in the clinical trial.10 The register is
considered as a humanitarian approach even though the
declaration of Helsinki is the responsibility of world
medical association.
3. INTERNATIONAL VIEW ON GCP:
GCP is considered as an international standard since
enormous experiments are conducted not only in several
centers but also in multiple nations, examiners
attentiveness in abiding GCP can mean the distinction
between a safe and effective trial and inappropriately-
developed, a failed trial which may take time and
materials but produce unacceptable data.
Using a specified and defined protocol the investigators
from various countries may register participants in a
trial. The results obtained from the clinical trials can be
merged into a single study only if all the investigators in
each country follow the same guidelines. If a researcher
likes to work on large experiments he should comply
with the GCP before he is being invited to participate.
GCP principles are revealed, explained and categorized
in various places and this lead to the interpretation of the
guidelines. Compliance with GCP means developing,
adopting SOPs into every aspect of research. As per the
US, Investigational New Drug Application (IND) each
examiner who is involved in conducting the clinical
research is required to sign Food and Drug
Administration (FDA) form 1572 quoting that the
individual will comply with GCP. It is necessary that the
form should be signed only after understanding the
responsibilities of the principal investigator. The
responsibilities include the regional conduct of trial and
reporting requirements as stated by FDA and the
sponsor involved in the clinical trial. The principal
investigators work as a team for conducting clinical
research. The team members are given the permission to
conduct a specific task by the principal investigator in
the form of a written procedure.11
The FDA monitors the systematic studies which are
developed to provide evidence and to support the
productiveness, potency and safety profile of
experimental drugs, biologicals and medical devices.
The studies must be conducted by a qualified scientist or
expert and should comply with the rules and regulations.
The sincerity of data obtained in a clinical trial on
product approvals is ensured by these laws and rules.
And they are intended to protect the rights, safety
andwell-being of human subjects participating in the
clinical trial.12
3.1. Difference between ICH-GCP and WHO-GCP
guidelines:
The ICH-GCP guidelines were framed by the same
experts in same parallel manner and hence they are
basically similar. The ICH -GCP was designed to
promote harmonization in the three prominent ICH
regions namely the US, Japan and EU to meet the
technical requirements for the registration of
pharmaceuticals for human use. The WHO-GCP was
developed as an instructional tool for less accomplished
pharmaceutical agencies in nations where there was no
existence of any other guideline. The main difference in
ICH-GCP and WHO-GCP is that the ICH-GCP is
comprised of 13 principles and the WHO-GCP is
comprised of 14 principles. Principles 5 and 6 in WHO-
GCP are combined in ICH-GCP. Apart from that, there
is a slight change in the order of principles. GCP is GCP
no matter whether it originates from International
Council on Harmonisation (ICH) or World Health
Organisation (WHO).13
4. PRINCIPLES GOVERNING GCP:
The creation of GCP guidelines not only intended to
protect the rights and safety of the study subjects but
was also intended to serve the interests of all parties
involved in the clinical research. The basic principles
governing the concept of GCP are as follows:9
 To assist and stimulate the attainment of a unified
standard, at a global level, for the conduct of
clinical research studies on human beings.
 To act as an educational tool for personnel
interested in clinical research or for clinicians
already engaged in research, by furnishing the
requisite information with respect to the

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requirements of GCP and its efficient
implementation.
 Assist clinical research editors to assess the
acceptability of the research submitted for
publication, and to enable regulatory personnel to
evaluate studies that may affect the use and
registration of certain medicinal products.
 To provide a general summary and any other
necessary advice on how to apply and how to
implement globally accepted GCP principles for
clinical research in human beings.
While the basic principles of GCP mentioned above,
give a brief sense of the essence of GCP, a highly
specific set of core principles established by the WHO in
1995 give an extensive idea of the intent and purposes of
GCP. These core principles are as stated below:14
1) The ethical principles established by the Declaration
of Helsinki should be strictly adhered to when
carrying out research in human subjects. The three
ethical principles namely justice, respect of public
and beneficiary, shall be considered above all other
GCP principles.
2) All research involving human subjects should have
scientific reasoning and should be reported in a
detailed, extensive protocol.
3) Any foreseeable risks and potential side effects
along with the potential benefits should be
intimated to the trials subjects.
4) Clinical studies involving human participation shall
be carried out only if the benefits that are
anticipated from the studies far outweigh the
potential risks.
5) The intended research can be carried out only after
obtaining the go-ahead from the institutional review
board or the independent ethics committee.
6) The protocol shall be approved prior to initiating the
clinical trials.
7) Voluntary informed consent shall be obtained from
the trial participants as per national requirements.
Incase of pediatric or geriatric patients or when the
trial subject is not capable of giving the consent by
himself, the consent form can be received from a
legally authorized representative.
8) Research studies inculcating human beings, as trial
subjects, should be allowed to carry on as long as
the risk-benefit analysis remains appropriate and
conducive.
9) The medical care of research subjects shall be the
responsibility of qualified medical personnel
(physician, dentist etc.)
10) Individuals who work on clinical trials as well as
other personnel involved in conducting trials shall
have requisite qualifications and shall also be
adequately experienced in the same.
11) All research data gathered and generated should be
recorded and stored in order to ensure accurate
reporting, verification and analysis.
12) The privacy of trial subjects shall not be disclosed
and shall be closely guarded by maintaining the
confidentiality of the reports generated.
13) Good Manufacturing Practices shall be strictly
implemented in case of investigational product
manufacture, handling and storage.
14) Strategies shall be put in place in order to execute
processes that ensure the caliber of every facet of
the clinical trial.
5. GOOD CLINICAL PRACTICES IN INDIA:
5.1. GCP and Human Experimentation:
In any field affecting human beings, thorough studies
are considered essential to provide data that can help
improve the adverse conditions for human beings. This,
in turn, demands motivation and encouragement at
multiple levels of engagement. The healthcare sector in
India has seen ‘research’ add problems and complexities
to an already convoluted system, by calling for
experimentation on human beings that may expose the
subjects to adverse reactions and risks. However, the
necessity of these experiments is realised by the society,
and hence these researchers are considered acceptable as
long as the subjects taking part are safeguarded from the
adverse effects. In a nation like India, instead of building
a sense of altruism and trust in them, industrial entities
are busy cutting corners and providing false data in
order to reduce costs and generate higher revenue.15
Hence, ethical issues are of utmost importance when it
comes down to conducting research on human beings.
Ideally, clinical trials should be conducted by making
the society a true stakeholder in the research process and
by winning the trust of the society as a collective, which
will encourage further public participation in such
research studies or trials. The society must become
familiar with the clinical study concept, which can only
be achieved if the entire process of conducting the study
is crystal clear and transparent.Though the Indian
clinical trial scenario is termed as one of the best in the
world as of now, it is not as uniform across a defined
standard as one would desire. Therefore, it was realised
that global trust as well as the trust of the local society,
in the Indian clinical scenario, will only be possible
when stringent GCP rules are brought into effect.
5.2. The Guidelines:
CDSCO Guidelines:
India has been globally recognised as a nation that offers
unique and distinct opportunities for carrying out
clinical trials due to the existence of a large patient
population, well experienced investigators and leading
medical institutions along with the added benefit of low
costs per patient used, in contrast with the developed

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3213
countries. Nonetheless, changing times necessitated the
establishment of our own Indian guidelines for GCP in
order to provide a steady quality to clinical research
studies initiated all over the country. Working towards
this goal, an expert committee was set up by the
CDSCO, which was provided able support by clinical
experts from different parts of the country, to formulate
the first recognised document for GCP in India in 2001,
which was tailored to Indian requirements. The DTAB,
the highest technical body as per the Drugs and
Cosmetics Act, strongly endorsed the adoption of these
GCP guidelines by the pharmaceutical industry, to help
carry out well organised clinical studies in India. These
guidelines were constituted keeping in mind already
well established and document GCP guidelines like the
WHO, USFDA, ICH-GCP and the EU GCP guidelines.
Apart from these, inspiration was also drawn from the
ICMR Guidelines for Biomedical Research on Human
beings.16
These guidelines have specified ten ethical principles,
all of which are in strict accordance with the most
current revision of the Declaration of Helsinki. The ten
core principles of the Indian GCP document have been
established more or less along the same lines as the GCP
guidelines of developed nations and encompass various
facets such as informed consent, community agreement,
non-exploitation of subjects, subject privacy and
confidentiality, risk minimisation, accountability and
transparency of investigators and sponsors, and above
all, the principle of essentiality, which states that
research trials should make use of human subjects only
when it is absolutely essential and when any other
alternative is unavailable.16 These guidelines necessitate
the formation of an Independent Ethics Committee,
which will be responsible for checking the suitability of
the Protocol, Reviewing the methods and documents
submitted by the sponsors with regards to subject
recruitment and also check the authenticity of the
Informed Consent forms signed by the trial subjects
prior to participating in the trial. The Ethics Committee
will initiate an ongoing review and will continuously
monitor the clinical trial studies, to ensure compliance of
Ethics. The Indian GCP guidelines specify the
composition of an Ethics Committee and also mention
that any institution can include its members, members
from outside institutions or communities if required,
when setting up the Ethics Committee.
ICMR Guidelines:
In biomedical research, constituting a standard set of
quality guidelines provides credibility to the results
generated and also provides the opportunity to
accommodate comparisons between clinical studies
carried out in different institutions, both locally and
globally. This saves a tremendous amount of time,
resources, money and at the same time prevents
plagiarism or replication of research work carried out
elsewhere. Registering the incredible pace and the
monumental potential for clinical research in India, the
ICMR introduced the Ethical Guidelines for Biomedical
Research on Human Subjects in the year 2000 to provide
guidance to researchers carrying out biomedical research
in India with regards to Ethical practices. At the time of
establishing the guidelines, it was decided to conduct a
periodic revision of the guidelines. Subsequently, these
guidelines were subjected to revision in 2006 to keep
abreast with current trends and developments. Certain
points in the international guidelines provided for
biomedical research, that are relevant to research
institutes of international collaboration, have been
inculcated in this version. The intent behind periodic
revisions is to update the scientific community at large
about most recent concepts of bioethics. The exercise of
periodic revision is one that is seen in most of the
developed countries and is also being undertaken by the
emerging developing countries.17
5.3. CHALLENGES FACED BY GCP IN INDIA:
Just as is seen in the case of most systems operated on a
large scale, the GCP system in India too has come across
a multitude of problems with respect to the conduct of
clinical trials. One of the most common problems
encountered is the lack of commitment of clinicians
towards conducting proper clinical studies. Certain
clinicians, due to their busy schedules, find it difficult to
accommodate time for conducting thorough clinical
research. In some cases, clinicians cannot even commit
to monitoring visits. In such cases, they assign their
duties to their colleagues who might be misinformed or
may have incomplete knowledge with regards to the
trial. A co-ordination breakdown between the
investigators and their respective assistants or other
personnel can result in the improper conduct of tests.18
Nonetheless, such difficulties can be overcome provided
that the clinicians responsible are willing to put more
effort and dedicate more time to the research studies.
Also, if India as a nation, is to remain competitive in the
modern-day scenario with respect to clinical research
conduct, then we must work towards achieving
international standards and attaining international
recognition for the successful implementation of a
dynamic GCP system.
Another glaring issue that requires immediate
addressing is the issue of quality and documentation.19
Many FDA inspections in recent times have unearthed
the fact that several sites in India for conducting clinical
trials can improve their quality if they choose to pay
closer attention to particular areas. Protocol non-
compliance, inaccurate records, informed consent
problems, adverse event reports see the highest number

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of quality lapses. In terms of documentation in general,
Indian pharmaceutical industry players need to
appreciate the value and practice of a meticulous and
detailed process.20 Because documentation represents a
written record for GCP concurrence. Based on the
maintenance of requisite documentation, an institute or
an organisation can be deemed to be compliant with the
norms stated by GCP guidelines.
Impact of the media and negative reports by the
professional press may diminish the trust, support of the
public and hamper their participation in clinical trials.
To state an example, a popular medical information
website once quoted in an article, “Human beings have
become a source of experimental animals in India and
are being exploited irrationally. Due to rigorous and
exhaustive Animal guidelines, the use of animals in
India has become a major problem and hence,
pharmaceutical companies have shifted their attention to
human beings as a replacement for animals, to conduct
their studies on.”21 In most cases, reports tend to lay an
emphasis on only the negative aspects of the data. The
Indian people have personal interests on the line with
respect to the implementation of a successful and
indigenous clinical study environment as such a
progressive study environment will bring treatments into
the market that will be conducive to their respective
needs, and will also support an efficient health care
system for the nation which will in turn spur the nation’s
economic growth. Hence, media houses engaging in
negative press reporting with respect to the clinical
study rules and regulations and the GCP guidelines will
seriously hamper the development of new drugs which
will have a direct effect on public health. In addition to
this, rising number of instances of unethical practices in
clinical research, which are further sensationalized by
the media, has led to sponsors looking at other countries
as options for conducting clinical research. International,
as well as Indian pharmaceutical companies, are shying
away from India and developing new pharmaceuticals in
other countries.
In a period of 5 years, from 2008-2013, reportedly, India
witnessed the death of as many as 2,262 patients
registered for clinical trials. This led to a massive public
uproar and also raised questions as to how such clinical
trial related deaths were occurring, in-spite of having
stringent Ethics and GCP guidelines in place. In the end,
the Supreme Court intervened, stating that
“Uncontrolled clinical trials are causing havoc to human
life” and stressing the need to put in place even stricter
regulations and norms for conducting clinical trials and
to keep a check on the investigators and sponsors
conducting clinical trials. The court also questioned the
Health Ministry for its inability to stop the use of public
as “Guinea Pigs”in the carrying out of clinical trials.22
Additionally, the court also mandated the
pharmaceutical industry to provide adequate
compensation to the patients participating in clinical
trials, as it was observed that, in India, the companies at
times, failed to disburse compensation to the patient for
putting himself/herself through the risks involved in the
experimental procedures.
5.4. SCOPE OF IMPROVEMENT:
The significance of clinical trials in contributing to
health services cannot be overemphasized. The lifespan
and wellbeing of humans can be improved by the
development of new medicament and treatment. With
increasing authority, there is a growing requirement for
better operation of the system so that research subjects
are protected and ethical clinical research, which is the
need of the hour in our country, is promoted.
Postgraduate teaching institutions must be encouraged to
conduct clinical research that is at par with international
standards in terms of quality.23
Responsibilities of ethics committee:
Standard operating procedures (SOP) and a body of
fundamental principles should be formulated by the
institutional ethics committee. This should include
representatives, terms and conditions of nomination, the
workplace and quorum requirements. The official
procedure, informed consent forms, case record forms,
inclusion/exclusion criteria and other source documents
regarding the trials are reviewed by the ethics
committee. The standard operating procedures must be
checked and reviewed regularly. The reviews done by
the ethical committee should be free from bias and any
sort of influence. The committee should mainly focus on
safeguarding the rights, dignity, safety and well-being of
the research subject participating in the proposed clinical
trials. The committee should ensure that the oversight
mechanism is in place (site visit, internal audit,
examining the ongoing trials). All the source documents
related to the proposed trial must be retained for a
minimum of 5 years after the trial is being completed.
Responsibilities of sponsor:
A person or organization which takes responsibility for
the initiation, management or financing of a clinical trial
is known as a sponsor. When a sponsor transfers clinical
trial data to a scientific body or a contract research
organization (CRO), stringent measures shall be in place
to ensure that any such transfer of data is well recorded
and documented. It is the responsibility of the sponsor to
ensure that the investigator who is conducting
experiments on human subjects is qualified, trained,
experienced to conduct the trial. Approval to conduct the
clinical trial should be obtained from the Drug controller
general of India (DCGI) and institutional ethical
committee. Their active participation is necessary for

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3215
monitoring the data, regulatory reporting and financing.
Responsibilities of investigator:
A clinical investigator involved in a trial is responsible
for ensuring that an investigation is conducted per the
signed investigator statement, investigational plan and
applicable regulations, for protecting the safety, dignity
and well-being of potential research participants. The
sponsor and the investigator should establish an
agreement on protocol, SOP, monitoring the safety,
audit procedure, and allot the trial related
responsibilities prior to initiation of the trial. An
informed consent from each research `participant is a
compulsory requirement for a clinical trial. The
investigator is expected to report any serious adverse
events which take place during the trial within a fixed
timeline. The protocol must be followed diligently by
the investigator, ensuring that all the individuals
promoting the study are aware of obligations and are
trained. The investigator is not allowed to perform more
than three trials at a time.24
6. CONCLUSION:
Good Clinical Practices in India have come a long way,
from being mere ideological concepts to being a set of
well-organized and methodical guidelines. They have
helped establish and maintain the highest standards with
regards to the planning and conduct of clinical trials.The
Indian GCP guidelines, governing clinical trials are now
at par with internationally followed GCP guidelines.
However, taking into consideration the vastness of the
country and the enormous population size, the necessity
for impartial supervision by efficient and regulated
bodies is paramount. It should also be noted that a
transparent monitoring system shall be in place, which
can be assured by bringing clinical trials results under
the domain of the RTI i.e. the Right to Information
Act.By emphasizing on the upgradation of already
existing infrastructure and control measures in place
through an extensive and coordinated programme of
clinical research education, a clinical trial environment
of zero-tolerance to non-compliance with GCP
guidelines can be created.
7. REFERENCES:
1. Guideline for Good Clinical Practice E6(R1). International
conference on harmonisation of technical requirments for
registration of pharmaceuticals for human use. 1996:1-53.
doi:10.1056/NEJMp1012246
2. Ministry Of Health and Family Welfare Government of India.
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