CLINICAL TRIALS IN INDIA

Prepared By
Sandeep Kumar Mohanty

2017

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Plot No. 188/ 191 Unit 9, Bayababa Matha Lane

 Table of Contents
Introduction ....................................................................................................................................3
Regulatory Agencies Of India .......................................................................................................3
Clinical Trial Practice In India.....................................................................................................6
Indian Acts/Orders related to Clinical Trials .............................................................................6
Why and How India Became a Favorable Destination for Clinical Trials? ............................7
Legal Issues in Clinical Trials .......................................................................................................8
Regulatory Framework ...............................................................................................................10
Roadmap for balance between need for strict regulatory regime and growth of clinical
trials in India ..........................................................................................................................…..11
Conclusion ....................................................................................................................................14

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 i. Introduction

Many global clinical trials organizations have relocated their clinical trial (herein after refer to as ‘CT’)
research units to India. The Indian CT industry has become one of the most cost‐efficient destinations
in the world. It is growing fast and has emerged as a popular destination for global clinical trials.
However, the process followed by the pharmaceutical companies for conducting CTs has raised
some critical issues. First of all, the Indian CT industry has not been able to ensure rapid
technological transformation and the building of capabilities required for development of new drugs
despite receiving help from the internationally acclaimed contract research organizations (herein after
refer to as ‘CROs’) in India. Although the CT industry has been able to take advantage of financial
gain from the global clinical trial activities conducted in India, capability‐building for development of
new drug is not occurring in a manner that can help the country tackle public health challenges.
Second, over the past few years, the CT industry has come to face regulatory challenges. It is
confronted with some serious ethical issues on account of its conduct with regard to containing
deaths. Between 2010 and 2012, around 2500 people died because of adverse effects of drugs under
trial. But, only a few participants received compensation in case of injury sustained or death. It is
argued vehemently that the Government of India needs to establish a policy framework for the Indian
CT industry to provide for easy access to affordable drugs developed through adaptive clinical trials
and create a regulatory environment capable of ensuring the conduct of clinical trials without violation
of humanitarian ethics and other social norms.

ii. Regulatory Agencies of India

There are four main regulatory agencies for clinical trials in India:

 Ministry of Health and Family Welfare

 Central Drug Standards Control Organization

 Indian Council of Medical Research

 Ministry of Chemicals and Fertilizers

A. Ministry of Health and Family Welfare:

This is the regulatory agency which is primarily dealing with healthcare. This government body
has several bodies under its administrative control. Some of them are:
 Medical Council of India

 Dental Council of India

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  Pharmacy Council of India

 Central Drug Standards Control Organization

 Hospital Services Consultancy Corporation Limited

This regulatory agency acts by prescribing the standards in order to ensure the safety, efficacy as
well as the quality of the products like Drugs, Cosmetics, Diagnostics and Devices. In addition,
this regulatory agency is also regulating the Market authorization of new drugs and clinical trials
standards. The role of Ministry of Health and Family Welfare in a clinical trial does not stop with
this alone. This body will also supervise the drug imports. Furthermore, it is this regulatory agency
which will approve the license to drug manufacture.

B. Central Drug Standards Control Organization:

It is the national regulatory authority that is being operated under the “Ministry of Health and
Family Welfare”. This is the primary regulatory authority for the pharmaceuticals as well as
medical devices in the nation. The Central Drug Standards Control Organization is serving the
parallel function to the U.S’s “FDA”, Japan's “PMDA” and European Union's “EMA”.

With this regulatory agency, it is the Drug Controller General of India who is regulating all the
pharmaceuticals and medical devices. As such, the DCGI is being advised by two other bodies
which are namely Drug Technical Advisory Board and Drug Consultative Committee. As such, the
whole regulatory agency has been divided into zonal offices to perform the following functions:

 Pre-licensing inspections

 Post-licensing inspections

 Post-market surveillance

 Recalls (if required)

The Central Drug Standards Control Organization is maintaining a good track record with 'World
Health Organization'. At present, this agency is planning open its international offices in China.

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 C. Indian Council of Medical Research:
This is one among the oldest research bodies of the country. This agency is being funded by the
Indian Government. The governing body of this organization is presided by the Union Health
Minister. And, this regulatory agency is being assisted by the scientific advisory board. Various
eminent experts in biomedical disciplines will assist ICMR in both scientific and technical matters.
This regulatory agency is acting to promote biomedical research in the country and is considered
as the apex body for the following activities:

 Formulation of biomedical research

 Coordination of biomedical research

 Promotion of biomedical research

ICMR is the regulatory body which has formulated guidelines for several aspects that are relating
to national health. Treatments for conditions like malaria, cancer, type 2 - diabetes and
retinoblastoma have been covered by various guidelines by Indian Council of Medical Research.

The ICMR guidelines that are pertaining to the clinical trial research in the country are:

a) Guidelines for biomedical research:

 General research principles for the research works that involve human subjects.

 Specific research principles for the research works that involve human subjects in
specific areas.
b) Guidelines for Good Clinical Laboratory Practices:

These guidelines are aiming to elucidate the step-wise procedures that are to be followed by
the laboratories for the purpose of strengthening the quality of all the test results. In India,
these guidelines must be taken up by all the ICMR labs which are engaging in clinical trial
research. A checklist will be prepared in order to monitor all these ICMR laboratories for
compliance with ICMR guidelines.

D. Ministry of Chemicals and Fertilizers:

This ministry in India is the primary administrative unit of the following departments:

 Department of Chemical and Petrochemicals

 Department of Fertilizers

 Department of Pharmaceuticals

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 The Department of Chemicals and Petrochemicals is involved in the following activities:

 Setting and revising the drug prices.

 Maintaining the data on production/export/import.

 Enforcing and monitoring the availability of medicines.

 Giving options to the parliament.

 Regulating the industrial policy on drugs in the country.

iii. Clinical Trials Practice in India

Global clinical research is exploring India. Yet, it is certainly not the West that is introducing
clinical research to India. Two ancient scripts, Charaka Samhita (a textbook of medicine) and
Sushruta Samhita (a textbook of surgery), compiled as early as 200 B.C. and 200 A. D.
respectively, show India’s age-old proficiency in medical research. However, a lot has changed in
the clinical research scenario since then. Today, clinical trials are conducted through a regulated
approach following certain guidelines laid down by the International Conference on
Harmonization (herein after refer to as ‘ICH’), which is spearheaded by U.S.A., Europe and
Japan. There are number of laws governing clinical research in India.

iv. Indian Acts/Orders related to Clinical Trials :

 Drugs and Cosmetics Act, 1940

 Medical Council of India Act, 1956 (amended in the year 2002)
 Central Council for Indian Medicine Act, 1970
 Guidelines for Exchange of Biological Material (MOH order, 1997)
 Right to Information Act, 2005.
 The Biomedical Research on Human Subjects (regulation, control and safeguards) Bill, 2005

Even though we have number of legislations the important one for clinical trials is The Indian Council
of Medical Research (hereinafter refer to as ‘ICMR’), 1947 (amended in the year 2002) , which was
set up in order to foster a research culture in India, improve and develop infrastructure and foster
community support. The Drugs and Cosmetics Act, The Medical Council of India (hereinafter refer to
as ‘MCI’) Act states that all clinical trials in India should follow the ICMR guidelines of 2000. The
ICMR has a mechanism of review for its own institutions, and so do other government agencies.
Every doctor is governed by the MCI Act. Any doctor doing violating the norms in a trial or in practice
can be prosecuted and the hospital can be closed. The MCI Act is very strong; the MCI has the power
to take punitive measures. The Drugs Controller General of India (hereinafter refer to as ‘DCGI’) is

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 responsible for regulatory approvals of clinical trials in India. The DCGI’s office depends on external
experts and other government agencies for advice. Additional permissions are required for the export
of blood samples to foreign central laboratories. The ICMR has a Central Ethics Committee on
Human Research (CECHR). This committee audits the functioning of this Institutional Ethics
Committee (IEC). The DCGI’s office in collaboration with WHO ICMR and many committed research
professionals, has been conducting training programs for members of the Ethics Committees across
the country.

v. Why and How India Became a Favorable Destination for Clinical Trials?

Global share of clinical trial (hereinafter refer to as ‘CTs)’ in India grew from 0.9 per cent in 2008 to 5
per cent in 2013. Like India, China also experienced the same growth path. On the other side, the
share of CT activities in the United States and other developed countries is declining. Global
pharmaceutical companies are relocating their clinical research operations to India and other
developing countries because of the various advantages offered by them (developing countries):
large patient pool, low cost of doing business, availability of expert researchers, and, huge
market opportunities. The pharmaceutical companies can access approximately three billion
potential new clinical trial volunteers in this location (BRIC CT Report, 2011). Analysis of the empirical
observations shows that various factors are taken into account prior to the beginning of any clinical
trial, for example, the location of institutional partner, infrastructure, internal facilities and prospect of
future product launches. Cost saving (35 to 60 per cent) and emerging market are also important
factors for conducting clinical trials. Revenue implications are equally attractive. Timeline including
recruitment process, timely completion of trials that translates into faster drug launch, a faster return
on investment, a potential edge over the competitor and large patient pools are also very encouraging
factors for conducting clinical trials in India.

India is home to more than 17 per cent of world population and around one‐ fifth
of the global burden of disease. The country also has the greatest burden of maternal, newborn and
child deaths in the world (WHO, 2013). India is facing dual burden of communicable and
non‐ communicable diseases (Government of India, 2005). According to 2012 WHO report, non
communicable diseases (NCD) are responsible for two‐ thirds of the total morbidity burden and about
53 per cent of total deaths in India. Also, due to financial constraints, the sick and the suffering poor
cannot undergo medical treatment. As a result, India offers these native patients for CTs. McKinsey
estimated that India accounted for one of the highest scores in terms of offering patients for clinical
trials compared to the other favorable nations. According to their estimates, India stood second (after
China) in terms of patient pool for CTs.

Another important factor that makes India an attractive destination is lower unit cost for
conducting trials. India ranks fourth after Russia, Argentina and China respectively in terms of clinical

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 cost‐minimization. Cost for clinical labour (clinical professionals, nurses, etc.) is reasonably low
compared to the other destinations. The relevant expertise for conducting CTs depends on certain
other factors like: presence of top 12 contract research organization (hereinafter refer to as ‘CROs’) in
the country, the availability of local supply market, and, the number of CTs conducted in the country
which indicates the level of experience. Another important indicator of expertise is the availability of
relevant skilled professionals, which includes the availability (number) of physicians, nurses or clinical
research assistants, number of clinical practitioners holding first rank in mathematics or computer
science or engineering disciplines, and availability of a diverse talent pool. The availability of
physicians can be measured through suitable proxies to doctors/physicians for CTs. Similarly, first
rank holders in mathematics or computer science or engineering disciplines were measured through
proxies to statisticians in the country. Further, it is seen that India, too, can offer a large number of
skilled professionals for CTs. India also ranks fourth in position after the US, China and Russia in
providing physicians and nurses as well as in terms of the presence of CROs in the country. India
only lags behind in providing statisticians for the study of clinical trials.

vi. Legal Issues in Clinical Trials

It is true that India can provide a huge patient pool for CTs. However, the process of recruiting
patients for CTs is questionable. Many a time, drug manufacturing companies prefer to recruit
patients through local recruiters/agencies. Most of the patients are very poor and their earning per
day is 50 cent only. Also, due to their economically poor background and lack of education, the
patients are not aware of their involvement and the possible risk of injuries. Many a time they ignore
the side effects like feeling weak or having body ache only because they are “monetarily
compensated” for it. The payment works as an inducement. In fact, the patient can earn up to $400
depending on the length of study and this payment outstrips their general income. The unethical
practice of financial inducement though seemingly an incentive leads to enrolment of volunteers in
more than one study at a time. This not only puts their lives in danger, but can also skew the
accuracy of test results that pharmaceutical companies and regulators rely on to judge a drug’s
safety. Until now, many people have fallen sick and several deaths have occurred. The Indian
government reports that across the country more than 2500 people have died in clinical trials since
2005, many participating in studies for Western pharmaceutical companies. But it is unclear that how
many people died or were injured due to their involvement in clinical trials because in many cases
there are no proper systems of documentation of death registration. According to an affidavit filed by
the Health Ministry in the Supreme Court in response to a petition by healthcare NGOs, there were 80
deaths due to clinical trials between January 2005 and June 2012. Further, between July 2012 and
August 2013, nine more such deaths were reported. However, compensation was paid only in 82
cases. The Ministry of Health and Family Welfare also acknowledged that 2,644 people died during
clinical trials of 475 new drugs between 2005 and 2012; and 11,972 due to serious adverse events

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 (excluding death) and out of which, 506 were said to have been caused by clinical trials. There are
several controversies regarding the number of deaths and injuries in CTs because different sources
reported different numbers. According to the DCGI, there were 2,031 deaths during clinical trials
between 2008 and 2011. Out of these, 668 had taken place in 2010, of which 22 were directly related
to clinical trials. In these cases, the companies conducting the trials had paid varying compensations,
but the DCGI was not aware of the amounts. Since 2005, more than 2,800 patients have died during
CTs and out of these, only 89 or about 3 per cent of the deaths occurred mainly due to the effects of
the drugs under trial. Of these, 70 victims received compensation ranging from ₹1,80,000 to
₹4,20,000. A study also reported that 666 deaths occurred alone in 2010; of these, 22 cases were
attributed to deaths on account of clinical trials and the rest were attributed to past medical history of
the trial participants. In 2011, this number reduced to 438, of which only 22 victims were paid
compensation on account of clinical trials. In 2012, 436 deaths were recorded during clinical trials but
compensation is yet to be paid with the government still ascertaining the number of deaths that have
occurred due to trials.

During clinical trial, a patient can die because of several reasons: life
threatening diseases like cancer, cardio vascular diseases like heart failure/stroke and other serious
diseases that the participant may have be suffering from in the past. Death can also occur due to
adverse effects of the trials. However, there is no standard protocol for post mortem mechanism to
investigate it. The pharmaceutical companies conduct investigations only to ascertain the cause of
death: whether it was the result of a clinical trial or simply because of a pre existing disease.
Compensation is to be given only if a death is said to have been caused due to clinical trial. Also, the
amount of compensation varies across different companies. But now, the government is in the
process of fixing a minimum compensation amount in case of death or injuries sustained during the
course of the trials. The Ministry of Health and Family Welfare has authorised DGCI to determine the
amount of compensation to be given in case of death or injuries sustained during trials.

Another unethical practice is the simultaneous conduct of Phase II and Phase

III trials by CROs. Clinical trial laws were amended in 2005 to help familiarize India with ICR activities
as well as allow for Phase II and Phase III trials to be conducted concurrently. Before 2005, Phase II
and Phase III trials were allowed with a phase lag that is, after their gross safety aspects were
somewhat known abroad. These concurrent clinical trials may have a serious adverse effect on the
trial participants, for instance, causing disability or permanent damage or death.

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vii. Regulatory Framework

Clinical trials, in addition to national laws, are governed by well established guidelines and directives
at international level like EU regulations and directives, ICH- Good Clinical Practices (GCP)
guidelines, recommendations of World Medical Association Declaration of Helsinki, Guidelines for
Good Pharmacoepidemiology Practices and ICMR guidelines. These guidelines, recommendations
and opinions are considered as "soft law" and are not legally binding but play an important role in
regulating these clinical trials. Most of the multi-national corporations carrying out clinical trials
worldwide voluntarily and as a good practice follow these guidelines and recommendations. These
guidelines and directives primarily aim at protecting the subject from taking undue risk in participating
in a clinical trial; enforce both voluntary consent to research and the continual assessment of risk and
benefit. In India, Central Drugs Standard Control Organization (herein after refer to as ‘CDSCO’) is
the primary authority and Drugs and Cosmetics Act, 1940 along with the rules framed there under is
the principal legislation for the regulation of clinical trials. Schedule Y of the Drugs and Cosmetics
Rules, 1945 provides for the detailed conditions, and compliances relating to clinical trials in India.
Recently on 30th January 2013, Government of India came out with certain amendments to Schedule
Y of the Rules with a view to tighten the norms relating to the conduct of clinical trials especially in
terms of taking informed consents from the trial subjects and providing them or their legal
representatives compensation in case of any trial related injury or death. The amendment has
imposed complete and ultimate liability on the sponsor of the clinical trial to reimburse any cost
incurred by the trial subjects for the medical treatment of "any injury" suffered by the trial subjects as
well as financial compensation for such injury or death. Further in case the sponsor fails to provide
the proper medical treatment and/ or the financial compensation as per the orders of the licensing
authority to the trial subjects or their representatives, then the authority may cancel or suspend the
license of the sponsor to carry out the clinical trials and may even debar it from carrying any clinical
trial in future in India. The amendment also mandates GCP compliance and adverse event reporting.
The amendment has certainly acted as a deterrent on the multi-national corporations and is a
negative catalytic agent to the prospects of clinical trials in India.
Although regulations relating to clinical trials have evolved considerably to match global standards,
many issues still remain. There are several grey areas in the regulations that need to be clarified.
Hence, often for several issues, authorities need to be consulted or the industry practices need to be
ascertained.
A major concern a foreign sponsor faces in India is the extreme shortage of regulatory
experts. Unlike FDA and EMEA, DCGI does not release guidance documents providing the current
interpretation of the regulations. Since the regulations described are meant to be general, their
interpretation is highly subjective and based upon the experience of the regulatory consultants. It is
not uncommon to have several experts come to different conclusions about the same regulation. The
sponsors should be aware of differences in the Indian GCP version of ICH-GCP, including the Indian

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 specifications for the composition of the Ethics Committee, informed consent procedures,
compensation for participation, as well as the roles and responsibilities of foreign sponsors
conducting clinical trials in India. At present the regulations do not permit first-in-man studies (Phase
I) for drugs discovered outside of India. More recently, there have been some discussions by the
Indian government to consider removing this constraint and update schedule Y to be more consistent
with US and ICH guidelines.

The Deficiencies in the functioning of the ethics committees and CROs:-

There are several CROs that carry out trials on behalf of the sponsors. However, it has been noticed
that some of the CROs lack adequate infrastructure and knowledge. Hence, it is advisable to carry
out appropriate due diligence of CRO before appointment. It has been observed that many clinical
research institutions in India have an inadequate representation of the non-technical personnel in
Institutional Ethics Committee (IEC). Without adequate representation of persons from a non-
functional background, the opinion of the IEC is likely to be unfair and biased in favor of the clinical
study. The clinical research guidelines clearly specify the need for such personnel in the IEC. Some
institutes have IEC but do not have a regular schedule of committee meetings, lack Standard
Operating Procedures (SOPs) or do not have a proper member representation according to the ICMR
guidelines.
However, things are changing fast for the better. New Schedule Y1 is
proposed which has mandated registration of CROs with the authorities and only these registered
CROs will be allowed to manage clinical trials. The Central Ethics Committee on Human Research
(CECHR) by ICMR audits the functioning of these IECs composed as per the ICMR guidelines. The
DCGI’s office has been conducting training programs for members of the ethics committees across
the country to improve the functioning of IEC, in collaboration with WHO, ICMR and many committed
research professionals.

viii. Roadmap for balance between need for strict regulatory regime and growth
of clinical trials in India

Following are some of the changes suggested in the existing law, which can go a long way to strike a
balance between the interest of the subjects and the growth of clinical trials in India:

Informed consent: Improvement in the system of obtaining informed consent from the subjects.
Audio/ visual techniques of recording should be used while explaining the subjects about the process,
the likely side effects and taking their consent. Further, subjects should be clearly informed about the
past records of such clinical trials and number of adverse effects/deaths reported due to such clinical

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 trials. Merely poverty and free treatment should not be the basis of engaging subjects in the clinical
trials. Investigators and sponsor should be morally responsible in this regard.

Restricting the liability of sponsors: Restricting the liability of the sponsors to the injury or death of
the subject which are resulting directly or sufficiently attributable to the participation of the subjects in
the clinical trials. With as many as 2,868 deaths during clinical trials from 2005 to 2012, only 89 have
been attributed directly to such trials. The timelines for payment of compensation should be
liberalized depending upon the case to case basis. A fixed timeline in all type of adverse events and
claims may not serve the purpose. Further the amount of financial compensation over and above the
cost of medical treatment should be quantified or objective criteria to determine the same should be
ascertained. For example, a terminally ill patient who chooses to be the subject of a clinical trial need
not be given the same compensation as a healthy individual who has opted to become the subject for
clinical trial. It should not be left at the sole discretion of the licensing authority or ethics committee.

Institutionalization and registrations: Independent research and trials should be restricted and only
institutionalized clinical trials to be carried out. It is commonly seen that investigators and doctors at
individual level carry out unregulated clinical research in private clinics and hospitals. This is required
to be checked by the authorities. Registration of clinical trials with Clinical Trials Registry India and
registration of clinical research organizations should be mandatory. This is already in place, however
the effective implementation of the same should be ensured.

Approval mechanism: Fast and time efficient approval mechanism is required. Objective criteria for
accepting or rejecting the applications, transparency in the entire process and the decisions for
rejection or pending applications should be supported with the appropriate reasons. It is to be noted
that the approval time for initiating drug trials in India typically runs from six to eight months,
compared to 28 days in Europe and Canada.

Transparency: Transparency from the side of investigators and institutions is also very important. It
is one of the core guiding principles in the ICMR Ethics Guidelines. Institutions and investigators
should be open to public about regarding kind of investigation, standard of care taken, subjects
involved, etc.

Inspection and auditing: Officials of the CDSCO or licensing authority carrying out the inspection of
the site should be of the same field with adequate knowledge and expertise on the subject. Also the
use of CCTV camera at the trial site to administer the whole procedure of trial should be
implemented. Further, involvement of the experts from the industry and legal field in the ethics
committee and more emphasis on institutionalization of the ethics committee is also necessary.
These would help the ethics committee and regulatory authority to investigate the matter more
efficiently.

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 Applicability of stringent laws: Multi-national corporations which are voluntarily following the
internationally recognized guidelines and directives or are governed by laws of other home countries
which are materially equivalent strict in terms of following the good clinical standards and protecting
the interest of the subjects, should not be made to comply with more procedural compliances and
practices and should be provided a conducive regulatory atmosphere for coming to India and carrying
out clinical trials.

Drugs with serious side effects: It is seen that most of the deaths occurred in the past few years is
due to some specific drugs which were time and again put to investigation and every time resulted in
the severe adverse effects. Special care should be taken in approving the clinical trials of such drugs
and only in exceptional cases and depending upon the utility of such drug the permission should be
given.

Role of media: Negative publicity of clinical trials and multi- national corporations involved in such
trials should be avoided and discouraged. Media should be responsible in spreading any critical
report relating to the clinical trials and same should be approved by the licensing authority in
advance. In past it is seen that out of the 2,868 deaths reported only 89 of them were taken place due
to clinical trials. Rest were either remotely related to the trial or were in regular course due to the
disease of the subjects. Such negative publicity discourages the sponsor and creates uncertainties in
the mind of the subjects. Rather media should emphasize on spreading awareness about such
clinical trials targeting the vulnerable sections who mostly get involved in trials as subjects.

Pending actions from the side of Government: The proposal of Ministry of Health and Family
Welfare with respect to forming a committee comprising of science and regulatory experts that would
formulate policy on drug approvals, clinical trials and drug bans should be implemented promptly.
Also the draft bill on Biomedical Research on Human Participants (Promotion and Regulation)
prepared by the Indian Council of Medical Research should be tabled in the parliament on priority
basis. It would be beneficial if the comments and suggestions of the experts from the industry are
taken.

Clarification: Removing the loopholes in the language of the amended schedule Y (for instance as
mentioned above the time period with respect to the reporting of serious adverse events) and bringing
clarity to the same.

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 ix. Conclusion

As the medical research world becomes increasing globalized, there is a need to make research both
methodologically and culturally valid. Conducting research on human subjects stretches the current
norms of medical ethics as well as stretching the current capabilities of international law. To rely
simply upon minimum standards of non-binding and vague medical ethics instruments for conducting
research on humans is both naive and culturally insensitive. Human lives are inherently complex and
no single ethical framework, including ours can claim to capture the complexity of research and
understand the ethical dilemmas that arise in these diverse settings. In accordance with universal
principals of justice, the "effective " participation of oppressed populations in decision-making will be
an instrumental step in combating the social, economic and political forces of globalization that
constrain human capabilities. A law will not guarantee anything look at how the laws on transplants,
on sex selection, are broken.
But having a law will help for those who are afraid of scrutiny, which are
conscientious. The group misusing the law will do so anyway. But with a law you can ask questions,
conduct an inquiry, and take action. To ensure that India becomes a leading nation in Good Clinical
Research, greater attention must be paid to promoting clinical research. The gap between the
developed and developing worlds needs to be narrowed in order to ensure global justice, particularly
with respect to the widespread availability of proven interventions in developing countries. The
emphasis is to ensure that Research ethics should be made an integral part of all biomedical
research. As such every stakeholder should consider research participants as central players, who
should be protected from any harm for which an appropriate legislation should be in place to ensure
the above.
It is concluded that the clinical trial industry in India has great potential to become
the most favorable destination in the world because of low cost of doing business, the availability of
skilled professionals, and, the availability of a large and diverse patient pool. Many global CROs
relocate their research units to India for drug development activities. Though the CT industry has
been taking advantage of the huge financial gains, technological transformation for development of
NCE is not happening. Also, the Indian public health industry only partially benefits from CTs. The
Government of India needs to establish a policy framework for the Indian CT industry to provide for
easy access to affordable drugs developed through adaptive clinical trials in India. There is also a
need to create a regulatory environment capable of ensuring the conduct of clinical trials without
violation of humanitarian ethics and other social norms.

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