CLINICAL TRIALS IN INDIA: ISSUES AND CHALLENGES

CHAPTER 1 : INTRODUCTION
Clinical trials are the set of practices and procedures performed on living organisms to
determine the safety and unfavourable effects of new drugs and treatment. This is one
of the important practices involved in evolving the medical research, as this is one of
the best ways to test the efficacy of a new medical drug. These trials are basically the
studies and research performed on humans as subject to evaluate the medical
performance of a drug or treatment. These trials are primary ways to find out the
performance of a new drug and new treatment. Due to the large number of diverse
participants available, efficient and talented scientists and low cost of trials, India is
one of the favorable destinations for the conduct of such trials. The need of clinical
trials can be enumerated as follows:
 To Determine The Efficacy And Safety Of A New Drug
This is the primary use clinical trial i.e. to check the safety and efficacy of new
drug and treatment.
 To Evaluate And Compare The Existing Treatments With The New One
Clinical trials are also one of the best ways to compare the existing treatments
with the newly developed ones.

 To study distinct methods of using the already Exiting treatments in order to make
them more effective, easier to use and to determine and decrease the side effects
of such treatment.
Clinical trials are important to look out the various possible and effective ways to
carry out an already existing drug or treatment.

 To Learn The Best Way To Use A Treatment In A Distinct Population Involving

Patients On Whom The Treatment Was Not Previously Tested.1

Clinical trials are often looked upon as the ways to check the outcome and
performance of a particular drug or treatment on various different set of

1
https://www.gktoday.in/topic/clinical-trials-in-india-key-issues/
 population.
Therefore clinical trials are important for the R&D in the medical practices yet it
require stringent regularization to prevent the abuse. The Drugs and Cosmetic Act,
1940 along with the allied acts and rules provide a legal framework to the clinical trials
in India and in this research an attempt will be made to understand this framework and
in evaluating the lacuna in them. This research will be directed in analyzing the legal
and ethical issued involved with such trials and the legislative approach to the subject,
primarily in India. An attempt will also be made to understand current legal
framework on the subject, the gap and the scope of improvement of current legislation
and the approach of judiciary on it.
MEANING OF CLINICAL TRIALS

Research study in human volunteers to address particular and specific health queries
to develop new drugs for a particular disease is Clinical trial. Clinical trials are one of

the most important mean towards the medicinal advancement. A clinical trial for a
particular drug takes nearly 9 to 10 years to reach the completion stage. 2 Clinical trials
are conducted in a stringent regulatory environment. Carefully conducted clinical
trials are the fastest and safest ways to find treatments that work in people and ways
to improve health.

The global clinical trials business is worth an estimated $50bn in 2008, with a growth
of rate of 10% as per Global Clinical Trial Business Report & Analysis 2008-2018. 3
The market will show considerable growth in the future. In recent years, the nature of
clinical trials has changed considerably. An increased emphasis has been placed on
cost- effectiveness of pharmaceutical Research & Development (R&D), as well as
increased productivity to maintain the high output of recent years. Consequently, the
pharmaceutical industry has witnessed rapid expansion of outsourced clinical services
in both the West and in developing nations, most notably India and China.
Importantly, pharmaceutical and biotechnological companies are increasingly
delegating the responsibility of clinical trials to Contract Research Organizations
(CROs).4

The World Health Organization (WHO) is a specialized agency of the United Nations
2
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4847363/
3
https://www.pharmiweb.com/article/global-clinical-trials-business-report-analysis-2008-2018
4
Supra Note 3.
 that is concerned with international public physical health. It defines clinical trial as-

“Clinical trials are a type of research that studies new tests and treatments and evaluates
their effects on human health outcomes. People volunteer to take part in clinical trials to test
medical interventions including drugs, cells and other biological products, surgical
procedures, radiological procedures, devices, behavioural treatments and preventive care.
Clinical trials are carefully designed, reviewed and completed, and need to be approved
before they can start. People of all ages can take part in clinical trials, including children.”5

Clinical trial interventions include but are not restricted to:

• Experimental medicines,
• Cells and other biological products,
• Surgical procedures and radiological procedures,
• Medical devices,
• Behavioural treatments,
• Process of care
• Preventive care
• Researchers may also conduct clinical trials to evaluate diagnostic or screening
tests and recent ways to detect and treat disease.

OBJECTIVE OF CONDUCTING CLINICAL TRIALS

clinical trials are designed to improve the medical knowledge related to the treatment,
diagnosis, and prevention of illness or health conditions. Some of common reasons for
conducting clinical trials are given below:

• To examine one or more interventions (for example, medicines, medical

devices, approaches to surgery or radiation therapy) in order to treat a disease,
syndrome, or condition
• Discovering different ways or finding alternatives to prevent the initial
development or recurrence of a disease or condition. These may include
medicines, vaccines, or lifestyle changes, among other approaches.

5
https://www.who.int/health-topics/clinical-trials#tab=tab_1
 • Assessing one or more interventions which are aimed at identifying or
diagnosing a particular specific disease or condition.
• Analysing new and improved methods for identifying a condition or the risk
factors for that condition .

• Scrutinising and measuring new methods to improve the quality of life and
comfort through supportive care for people with a chronic disease.

TYPES OF CLINICAL TRIALS

Clinical trials include a broad range of different types of experimentation. Trials are
often used to test recent medicines or vaccines but can also be used to look at recent
combinations of existing treatments or to test whether giving a particular treatment in
a different way will make it more effective or reduce any side effects. Clinical trials
can also be categorised according to their objectives. For example, they might be
prevention trials, treatment trials or diagnostic and screening trials. Below are
descriptions of some different kinds of clinical experimentation.6

TREATMENT TRIALS

Treatment trials (also called interventional trials) are clinical trials which aimed to test
treatments or combinations of treatments which have not yet been officially
approved. These types of trials determine the effectiveness of a potential therapy or a
treatment or method of using a standard therapy for a particular disease like for cancer
patients. These trials test investigational medicines, vaccines, combinations of various
therapies and experimental approaches to surgery and/or radiation treatment.

For example, if a pharma company developed a new medicine which it believes

would be effective in the treatment of Cancer. But in order to ensure the safety and
effectiveness, first it must test the same on human volunteers in accordance with strict
and rigorous instructions following the requisite guidelines. Some medicines might be
aimed at curing a particular condition, whereas others might be aimed at better
controlling symptoms of a particular condition.

PREVENTION TRIALS

6
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3272827/
Prevention trials involve tests which are directed to find different ways to prevent a
particular medical conditions or if people have them already, to prevent them from
reoccurring. The emphasis of these analysis might be on medicines, vitamins and
minerals or lifestyle changes which may be an aid to prevent a particular disease.

Prevention experimentation looks for better ways to prevent disorders from

developing or returning. This type of trial determines the recent approaches for
preventing or lowering the risk of developing a particular disease. These often involve
healthy people who have not had that particular disease, yet may have a higher risk of
developing that disease.

DIAGNOSTIC & SCREENING TRIALS

Diagnostic and screening trials are aimed at finding recent ways to detect and
diagnose medical conditions (e.g. a better test, a more effective procedure or a more
sophisticated tool). Diagnostic trial is a research tests or procedures that could be used
to identify a disease more accurately. Diagnostic trials usually include people who
have signs or symptoms of a disease.

The purpose of a diagnostic test is to establish the presence or absence of a disease as

a basis for treatment decisions in symptomatic or screen positive individuals The other
word for such trial are confirmatory trials.

The primary purpose of screening tests is to detect early disease or risk factors for
disease in large numbers of apparently healthy individuals. These trials are directed in
testing the best ways to try to find a disease at it's earliest stage, so that hopefully the
chances of cure are higher, and the amount of treatment needed will be less.

PROCEDURE OF CLINICAL TRIALS

Clinical trials, in their purest form, are designed to observe outcomes of human
subjects under experimental conditions controlled by the scientist. A clinical trial
requires a well-designed protocol that needs to be observed and followed,
collaboration among various medical professional and special institutes, and effective
reporting of the findings. It is carried out under the direction of the principle
investigator who is in the main charge of the trial. Clinical trials are carried out in
different settings like community hospitals, academic hospitals, specialty treatment
 centers. After a clinical trial is completed, researchers analyze and report their
findings to the concerned authority of the country, which is the governing nation of
such trials. A clinical trial is carried out in different stages, which shall be discussed
in detail in the following sections.7

CONFIDENTIALITY

Confidentiality is one of the moral as well as legal obligation upon the investigators
while conducting clinical trials anywhere in the world. In reporting the results of a
clinical trial, every effort is to be made to maintain the confidentiality of patients’
research records.8 Patients must be informed about the person who will be responsible
to inspect their medical and research records. Patients must not be referred by their
name and, unless required by law, patient identity is to be kept completely
confidential.

WHERE CLINICAL TRIAL ARE CARRIED OUT

Researchers conduct clinical trials at various places and settings. It can be done at
many locations such as hospitals, community clinics, doctors’ offices, and
universities. The selection of a place for conducting clinical trials highly depend upon
the nature of the trial and who is conducting a trial.

For example, many cancer clinical trials are done at cancer centers because the
facilities available are usually the most advanced and so is the case of other specialized
research. In the past, almost all clinical trials were done at cancer centers. Today,
community hospitals and doctors’ offices also can be part of a clinical trial. This
provides more options to people who decide to participate in a trial. Instead of
travelling to a distant cancer center and getting treatment from a doctor they don't
know, people in clinical trials may be able to stay local and see their own doctor (as
long as he or she is involved in the trial). The experimentation team that conducts a
clinical trial can include experimentation scientists, doctors, nurses, social workers,
dieticians, and other healthcare professionals.

DURATION OF STUDY

All medicines and treatments that are to be subjected to humans must have to be
7
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3272827/
8
Supra note 7
 thoroughly tested before they are licensed and available for patients. It takes time for
a recent medicine to go through the various stages of testing called phases of trial.
There is no typical length of time this takes, it varies from trial to trial. It might take
10 to 15 years or more to complete all the phases of clinical trials before the licensing
stage.9 For example, the BIG 1-98 trial, which compared Femara and tamoxifen after
surgery to treat early- stage breast cancer, was started in 1998. The women took the
medicines for 5 years and then were followed for several years after treatment, so the
first results were available in 2005, 7 years after the trial began. 10 In most cases,
researchers like to have 5 to 10 years (or more) of follow-up data so they can be sure
that any long-term side effects are discovered. But this time span varies a lot and
depends on many factors, such as type of disease, type of treatment, the length of
treatment, follow up period, any problem with recent medicine, number of patients
enrolled etc.

CHAPTER 2 : CLINICAL TRIALS IN INDIA

In India the clinical trial which we see today are a result of various changes in the past
in this aspect. In recent years, India has proven itself as a solid-performing region for
conducting clinical trials. As it has evolved and emerged, it has caught the attention of
global pharmaceutical and biotech companies.11

There are various factors adding to the growth of India in such sector such as India,
with a population of over 1.15 billion people, has one of the largest patient
populations in the world. In addition to its large patient population, India has nearly
700,000 specialty hospital beds, 290-plus medical colleges, and skilled English-
speaking medical professionals which make a great combination for a suitable clinical
trial site in India.

The country's evolution in clinical experimentation field has a long history. India has
a rich heritage of traditional medicine which is Ayurveda. Ayurveda is now worldly

9
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4847363
10
https://pubmed.ncbi.nlm.nih.gov/19692688/
11
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149409/
 accepted as a very effective field of medicine and people all over the world are trying
to incorporate its essential within their system.12

The classic Ayurvedic texts contain detailed observations on diseases and in-depth
guidance on remedies. It is likely that these descriptions are based on direct
observations made by the ancient Ayurveda experts. However, there is no recorded
documentation in the ancient texts of any clinical experiments. Hence, one has to fall
back on current history of medical experimentation in India.13

EARLY HISTORY OF CLINICAL TRIAL IN INDIA

There is a huge volume of literature available in the country that has written and
thrown light upon the phenomenal growth of the clinical trials industry. There are two
sets of available literature, these sets can be categorized in two different heads on the
basis of their approach to the subject of clinical trials. One is those writings that have
given greater play to societal concerns over the growth of clinical trials industry and
the malpractices that it has engendered in the name of clinical experimentation and in
the second group are the writings that have argued in favor of the growth of clinical
trials industry as an economic opportunity as being crucial to the development of
clinical experimentation in the country and as such have deliberated on the ways and
means to take best advantage of the opportunity.14

The growth and development of medical trials in the India over the last nine decades
have been reflected by the corresponding evolution of Indian Council of Medical
Research’. Indian Council of medical research is the renamed name Indian Research
Fund Association (IRFA)15 Sir Harcourt Butler headed the first meeting of the
Governing Body of the Indian Research Fund Association (IRFA) which was held on
November 15, 1911 at the Plague Laboratory, Bombay. In its 2 nd meeting in 1912, a
historic decision to start a journal for Indian Medical experimentation was taken by
governing body.

12
Supra Note 9
13
Ibid
14
Vikas Bajpai, Rise of Clinical Trials Industry in India: An Analysis, ISRN Public Health, Volume 2013 (2013),
Article ID 167059
15
https://ijme.in/articles/indian-council-of-medical-research-then-and-now/?galley=html
 Between 1918-1920, many projects on malaria, kala azar and other indigenous
medicines were initiated.16 In the year 1945, a Clinical Research Unit was established
at the Indian Cancer Research Centre, Bombay which was the first experimentation
unit of IRFA attached to a medical institution.” In 1949, IRFA was re-named as the
Indian Council of Medical Research.17

In past 60 years, ICMR has established many national experimentation centers in

various fields including nutrition, tuberculosis, leprosy, viral disease, cholera, enteric
disease, reproductive disorders, toxicology, cancer, traditional medicine, gas disaster,
genetics, AIDS etc.18

ICMR constituted the Central Ethical Committee on Human Research. Committee held
its first meeting on September 10, 1996. Many subordinate committees were also
formulated to consider ethical issues in specific areas e.g., Epidemiological Research;
Clinical Evaluation of Products to be used on Humans; Organ Transplantation;
Human genetics etc.19 “In the year 2000, the central Ethics Committee released
Ethical Guidelines for Biomedical Research on Human Participants which were
subsequently revised in 2006. In the year 1988 Schedule Y of the Drugs and
Cosmetics Act came into force and established the regulating instructions for clinical
trial (CT) permission. This was the major piece of legislation in regulating clinical
trials in India.This schedule forced the clinical industries to conduct Phase III clinical
trials for registration of a new medicine and supported growth of a predominantly
generic Indian pharmaceutical industry. However, the unlamented schedule Y only
allowed clinical trials at a stage below than its global status. This stage lag blocked
integration of India in international clinical development and India stayed lag behind
the International Standards and the need to revise this schedule was felt.20

The revision of the Schedule Y in Jan 2005 has been the next major step. Schedule Y
of 1988 had narrow and restrictive definitions of clinical trial phases while the
amended Schedule Y of 2005 provided pragmatic definitions for Phase I to IV. The
instructions and definitions for clinical trial phases are wide and rational. The earlier

16
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5464238/
17
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149409/
18
Supra note 15
19
Ibid
20
Ibid
 restrictions on number patients and centers in early phases stipulated in Schedule Y
1988 were also removed allowing the sponsor company freedom to decide these in
relation to protocol requirements.” The stage lag requirements gave way to
acceptance of concurrent Phase II-III as part of global clinical trials.

CONTRACT RESEARCH ORGANIZATIONS (CROs)

A CRO (Clinical/Contract Research Organization) is an organization contracted by
another company to manage and lead the company's trials, duties, and functions.
Organizations and businesses that contract with CROs do so to acquire specific
expertise without hiring permanent staff. CRO are considered as a way to reduce the
time it takes to conduct a trial that occur while doing the trial in-house by firms or
public entities who want a clinical trial to be conducted, and that translates to
significant cost savings. A contract with an outside company means that the hiring
organization does not need the infrastructure, office space or manpower to run these
trials themselves. Contract research organizations (CROs) provide clinical trial and
other research support services for the pharmaceutical, biotechnology, medical device
industries and also serve government institutions, foundations, and universities. In the
changing economy, pharmaceutical companies are increasingly looking to outsource
critical functions, including manufacturing and research. More and more of the
major corporations are using CROs to lead clinical trials and develop new
medications.21

POST WTO

India became a member of the World Trade Organization (WTO) in 1995 and agreed
to adhere to the product patent regime by 2005. As a result, the global pharmaceutical
industry has the rights to patent products as well as processes throughout the world,
including India. This encouraged great medical advancement and gave impetus to the
medical researchers in the field. This has led to a significant growth of the
pharmaceutical industry, both domestically in India and globally, including increased
stakes of multinational companies in Indian operations.
The harmonization of patent laws in the post-WTO scenario has seen a steady shift of
clinical trials to many developing countries, India being one of their chief recipients.
21
https://www.thebalancesmb.com/contract-research-organizations-cro-2663066
 There has been a resultant growth of CROs in the country and pretty much the same
practices that constitute the pantheon of business practices of CROs in the West are
being adopted in India as well. The only difference is that the patients here could be far
less empowered to ensure that their interests are well taken care of; they invariably are
far poorer than trial subjects in the West which renders them much too vulnerable.

REASONS FOR INDIA BEING ONE OF THE FAVOURABLE DESTINATION

FOR CLINICAL TRIALS

The major factors among others responsible for considering India as a favorable
destination for clinical trials are

 Infrastructure for the trials,

 Trained manpower,
 Speed and quality of trials,
 Reduced cost of conducting trials.

Costs of conducting clinical trials in the developed countries have increased over the
years, and therefore research-based multinationals are outsourcing stages of clinical
trials to the developing countries such as India and China. More than the present ratio of
clinical trials will be outsourced to developing countries in the near future. The
government is also making guidelines in furtherance of increasing the role of India
and its position in the global market. India will play an increasingly important role in
this segment, due to the genetically-diverse population, abundant technical talent, low
costs and sound infrastructure, among other reasons.22

ISSUES AND CHALLENGES IN CONDUCTIN CLINICAL TRIALS IN INDIA

The major issues and challenges in conducting clinical trials in India are :-
 Finding the volunteers for the trials.
 Quality of the data which is to maintained.
 Protection of research participant.
 Ethical problems and issues in adhering to local and international guidelines
for clinical trials.
22
https://www.quanticate.com/blog/outsourcing-to-a-clinical-research-organization
In clinical trials drug under development for a particular disease must undergo extensive
research in animals and humans to establish and understand its safety and efficacy at a
particular dose, prior to being marketed. Pharmaceutical companies, allot a certain
percentage of their revenue to be re-invested in drug development, to complete the circle of
R&D.23

Clinical trials represent a bridge from early stage drug development to commercialization, a
bridge which cannot be bypassed and is very long and expensive to cross. It takes
approximately 800-1,000 million US$, which vary from trial to trial to bring a drug from
the lab to the market. This usually occurs over a widely varying time-span, 9 years on an
average. Most companies would be happy to be able to reduce this to around 6 to 7 years, to
maximize the commercial benefits out of it which are main inducement if such trials.24

A large portion of drug development costs arise from clinical research, especially from
large scale multi-centric programs undertaken for such research. Understandably, the most
expensive failures are the ones which occur in later or end stage of development. Hence
pharmaceutical companies endeavor to determine the risk of failure associated with a
particular drug as early in development as possible.

Only the most potential "acceptable risk" compounds are progressed into clinical
development. Approximately 1 of every 10,000 compounds will complete its eventful
journey from the lab to the pharmacy shelf and therefore the risk involved is way to high
then the probable result.

In this process of drug development, the conduct of clinical trials in a developing country
like India, will help the researcher to maximize their benefits from such research. Before a
pharmaceutical company can initiate testing in humans, it must conduct extensive
preclinical or laboratory research. This research typically involves years of experiments in
animal and human cells. The compounds are also extensively tested in animals. If this stage
of testing is successful, a pharmaceutical company provides this data to the concerned
authority for the country requesting approval to begin testing the drug in humans. This is
called Investigational New Drug application (IND).
CHAPTER 3: LEGAL ISSUES AND CHALLENGES WHILE CONDUCTING

23
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4847363
24
https://www.ncbi.nlm.nih.gov/books/NBK56179
 CLINICAL TRIALS

The two prominent governing piece of legislation in respect of clinical trials in India
are Cosmetics Act of 1940 (Act) and the Drugs and Cosmetics Rule of 1945 (Rule).
All clinical trials in India are carried out under Schedule Y of the Drugs and
Cosmetics Act of 1940 (Act) and the Drugs and Cosmetics Rule of 1945 (Rule). Both
pieces of legislation have been amended several times over the years. A clinical trial
cannot be initiated unless the permissions as per the regulatory requirements are put in
place by the sponsor. However these process brings with them certain legal and
ethical issues which are pertinent to be mentioned before dealing with the other
chapters of the research. In this chapter such regulatory legal issued which come up
while conducting clinical trials will be discussed.
The increase in the research practices of the country leading to advancement in
research activities in the country has raised many legal issues in this respect. Various
guidelines have been formulated by organisations and authorities, which serve as a
guide to promote integrity, compliance and ethical and legal standards in the conduct
of research. Fraud in research undermines the quality of establishing evidence-based
medicine, and interventions should be put in place to prevent such practices. A
general overview such legal principles will enable research to be conducted in
accordance with the best practice.

The approval process is one of the major issue of concern in this regard. During the
discussions with Experts, regulatory bottlenecks with the time in obtaining permission
for conduct of clinical trials were identified as one of the key challenges. These
approval process takes a minimum of three to six months, much longer than the time
required for similar FDA and EMEA reviews. Compared to regulatory authorities in
Canada and UK where approval time is generally 30 days, India may be slow,
although the regulatory environment has matured and the process is now streamlined
and somewhat predictable. Though with the new 2019 notification this has been
addressed but its impact and effectiveness can be witnessed only in future.

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.
The constant zeal of the authorities and their efforts in this subject seems to be
questionable. 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 multiple guidelines create a situation of confusion for the sponcers. The sponsors
should be aware of differences in the Indian GCP version of International Conference
on Harmonisation-GCP, including the Indian 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.

India's clinical research regulatory processes are well-defined, requirements for

conducting trials are clearly laid down in Schedule Y. This law governs the conduct
of clinical trials in India. Since the release of amendment to Schedule Y in 2005, there
has been a tremendous increase in the number of clinical trial applications to the
Indian regulators. To harmonize the Indian review process with that of FDA, the DCGI
released a new policy on clinical trial approval in November 2006. Under this policy,
all clinical trials are divided into two broad categories: A and B based upon
information provided by the sponsor at the time filing for permission.

 Category A : Includes those clinical trials whose protocols are approved by

government agencies of USA, UK, Switzerland, Australia, Canada, Germany,
South Africa, Japan or the EMEA. The time frame for such clearances is on
fast track; approvals are granted within 4 to 8 weeks.
 Category B: All the other applications which are not covered under Category
A fall under Category B. The approximate time for this is approximately 14
weeks.

However, once approvals are granted, there is little oversight by the regulators. This
may be because of inadequate resources and requisite training of regulatory
personnel. There may be poor clarity and understanding in review of data, e.g. if the
 product under investigation is a genetically recombinant vaccine. It is suggested that
this impediment be further researched.

Regulatory processes are not clearly defined with respect to biotechnology/herbal

products and medical devices since these categories of products need separate
framework and cannot be clubbed in the same bracket as classical small molecule
drugs.

DCGI's office have now started conducting regulatory inspections at investigator

sites. Attempts are made to bring the guidelines and regulatory framework in the line
of foreing affairs. The harmonization process or regulatory mechanisms is currently
underway as members of the regulatory office are interacting with international
regulatory agencies for exposure to global norms. Officials from World Health
Organization (WHO), US Food and Drug Administration (FDA) and Health Canada
conducted 'train the trainer" workshops for zonal drug inspectors, who will in turn,
train their staff at the state level. These measures have helped train the regulators in the
area of review and approval of clinical trials.25

LEGAL ISSUES AND CHALLENGES

The various legal issues faced by the researcher which acts as an impediment in the
research advancement of the country are enumerated as follows :-

1. Approval process :-

The approval process in India by concerned authorities may take 4 – 5 months,

unlike in the US, where a sponsor can proceed with a clinical trial 30 days after
submission of an application. The shortage of adequate number of skill staff lead
to delays in getting approval for trials.

2. Export of Biological samples :-

This is one area that is currently a difficult proposition for sponsors. There
is no single window approach for clearance of application for export of
biological samples. The application is made to the Department of Foreign Trade
in New Delhi, which takes a long time to clear.

3. Intellectual Property Protection:-

Authors and researchers have an ethical obligation to ensure the accuracy,

25
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3043366/
 publication and dissemination of the result of research,26 as well as disclosing to
publishers relevant corrections, retractions and errata, to protect scientific
integrity of published evidence. Every research study involving human subjects
must be registered in a publicly accessible database and the results made publicly
available.27 Sponsors of clinical trials must allow all study investigators and
manuscript authors access to the full study data set and the right to use all study
data for publication.28 Source documents (containing trial data) and clinical
study report (results and interpretation of trial) form part of the essential
documentation that must be retained for a length of time prescribed by the
applicable local legislation.29

4. Informed Category:-

The criteria and requirement of informed consent is very important and non
observance of the same can be futile to the whole trial however in India, getting
fully informed written consent from patients may not be easy; given the large
numbers of languages and dialects spoken, migration of people from one state to
another and different levels of literacy.

5. Coordination Between the Authorities

A single window co-ordination between different regulatory agencies with expedited

approval timeframes will help in shortening the study start-up timelines drastically.
There should be no requirement for the sponsor to obtain an Export License from
another Ministry. Regulatory approval for a study should suffice, both to import study
drugs and clinical supplies as well as export biological samples. Clinical trials must be
prioritized. Various regulatory bodies have been constituted to uphold the safety of
subjects involved in research. It is imperative to obtain approval from the appropriate
regulatory authorities before proceeding to any research. These approvals often take

26
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-
involving-human-subjects/
27
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-
involving-human-subjects/
28
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
29
https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
a lot of time to come into place leading to the loss of time of researcher. An approval
of a clinical trial should be on the basis of the following:-

(a) the potential benefit of the candidate drug and its relevance to a large fraction of
the Indian population;

(b) drugs which are of relevance to Indian population but are not of high interest in
the West, e.g. leishmaniasis which is common in parts of Bihar and Uttar Pradesh.

6. Disparity in the nature of the trials are not considered while drafting the
regulations
Lucid guidelines must be defined with respect to biotechnology/herbal products
and medical devices. Medical devices may fall under a separate regulatory
category. There should be a thorough review of the site's ability to safely
conduct the trial in line with India GCP and Schedule Y requirements.
Currently, sponsors only notify the regulatory authorities if any additional
investigator sites are included in the study.

7. Unprecedented growth of CROs

A proper check on CROs is not maintained. Criteria for refusing permission for
a study in India needs to be spelt out. There has been an unprecedented
growth of CROs in India and almost all Indian and Multinational Companies
have set-up local operations either directly or through joint ventures. There
should be a regulatory system in place to register, certify and approve CROs
based on their capabilities to carry out clinical research and it should be applied
as well.

8. Unclear guidelines on study related injury

National Guidelines should be amended to provide greater clarity on issues

such as compensation for study-related injury, risk-benefit analysis while
reviewing research protocols, role of EC in serious adverse events review
process and role of the Data Safety Monitoring Board (DSMB). An appropriate
formula for and a revised formula taking into consideration all aspects must be
made.
 9. Access to drugs

The regulation process in obtaining the desired drugs act as hurdels in such
trials.Another issue that arises is the liability of the sponsor to provide access
to drugs and treatment post termination of the trial. Depending upon the study
protocol, availability of the drug and stage of the trial, this issue needs to be
addressed. The patent and other regulation pose problems in the easy access of
the drugs.

10. Clinical Trial liabilities

The sensitivity of the clinical trial in view of the involvement of human subject
can be well understood and appreciated. The human subject can either be
healthy volunteers or patients suffering from disease for which the drug is
being tested. All the stakeholders involved in conducting the trial have
significant exposure to liability. Generally, the targets for litigation are the
investigators and the institution involved. The company that sponsors the trial
is also exposed to the risk of liability on account of improper disclosure,
conflict of interest, violation of good clinical practices, injuries occurring due
to the test drug. Not many cases have reached courts in India, however, the
awareness amongst patients is certainly increasing. Further, there are certain
NGOs that take up the cause of study subjects.

CHAPTER 4: ETHICAL ISSUES AND CHALLENGES WHILE

CONDUCTING CLINICAL TRIALS

Ethics are the proper code of conduct which must be observed in all spheres of life
and complete disregard of the same in any sector would be futile for any activity and
the same is for clinical research. Ethics is rooted in the ancient Greek philosophical
inquiry of moral life. It refers to a system of principles which can critically change
previous considerations about choices and actions.30 It is said that ethics is the branch
of philosophy which deals with the dynamics of decision making concerning what is
30
Johnstone M., Bioethics : A Nursing Perspective, 5th edition, 2009
 right and wrong. It provides with the picture of wrong and right. Scientific research
work, as all human activities, is governed by individual, community and social values.
Research ethics involve requirements on daily work, the protection of dignity of
subjects and the publication of the information in the research.

Human experimentation has been conducted even before 18th century. However, the
ethical attitudes of researchers drawn the interest of society only after 1940's because
of human exploitation in several cases. Professional codes and laws were introduced
since then in order to prevent scientific abuses of human lives.31 The Nazi experiments
led to the Nuremberg Code (1947) which was the leading code for all subsequent
codes made to protect human rights in research. Nuremberg code is one of the vital
pieces of document emphasizing on human rights. This code focuses on voluntary
informed consent, liberty of withdrawal from research, protection from physical and
mental harm, or suffering and death. It also emphasises the risk- benefit balance.32 The
only weak point of this code was the self regulation of researchers which can be
abused in some research studies.33 All declarations followed, forbade nontherapeutic
research. It was only in 1964 with the declaration of Helsinki that the need for non
therapeutic research was initiated.34 The declaration emphasized the protection of
subjects in this kind of research and strongly proclaimed that the well being of subject
is more important than scientific and social interests.35

As enumerated in the previous sections there have been multiple reasons for India to
be a favorable destination of clinical trials in the country for International
pharmaceuticals companies. India's potential for fast recruitment of patients and
reduction of clinical trial cost made the country one of the most attractive strategic
imperatives for global clinical trials. However, globally, there has been a concern
about ethical implications of globalization of clinical trials to developing countries.

31
Oddi L.F., Cassidy, V.R, Nursing Research in the U.S.: the protection of human subjects., 1990;pp: 21-34.
32
Burns N., Grove, S.K, The practice of nursing research: Conduct, critique, and utilization 5th ed. St. Louis,
MO: Elsevier/Saunders, 2005.
33
Supra note 32
34
Watson A.B., Informed Consent of special subjects: Nursing Research,1982;: pp- 43- 47.
35
Oddi L.F., Cassidy, V.R. Nursing Research in the U.S.: the protection of human subjects. International
Journal of Nursing Studies, 1990; pp- 21-34.
These concerns have also been reflected in Indian literature and media stories, which
have highlighted issues of vulnerability, consent deviations, compensation for
patients, Ethics Committee (EC) training and functioning etc. These individual
opinions could have an impact in shaping the perceptions of clinical research
professionals. Therefore in this section major ethical issues surrounding the clinical
trials will be discussed.

As enumerated in the previous sections there have been multiple reasons for India to
be a favorable destination of clinical trials in the country for International
pharmaceuticals companies. India's potential for fast recruitment of patients and
reduction of clinical trial cost made the country one of the most attractive strategic
imperatives for global clinical trials. However, globally, there has been a concern
about ethical implications of globalization of clinical trials to developing countries.
These concerns have also been reflected in Indian literature and media stories, which
have highlighted issues of vulnerability, consent deviations, compensation for
patients, Ethics Committee (EC) training and functioning etc. These individual
opinions could have an impact in shaping the perceptions of clinical research
professionals. Therefore in this section major ethical issues surrounding the clinical
trials will be discussed.

ETHICAL ISSUES AND CHALLENGES

Major ethical issues highlighted with regards to the clinical trials, those need to be
addressed and taken care of while conducting clinical trials are as follows:-

1. Informed Consent: Informed consent seeks to incorporate the rights of

autonomous individuals through self- determination. It seeks to prevent
assaults on the integrity of the patient and protect personal liberty and
veracity. A proper information about all aspects of research must be made to
subjects so that they can take an informed decision which is generally not
followed. In addition the subjects need to know any expected benefits either
to the subject or to science by gaining new knowledge. The researcher must
inform the subjects about the methods which will be used to protect
anonymity and confidentiality and indicate a person with whom they can
discuss the study.

2. Involvement of large stakes and powerful people prevent the:

 information to be explicitly available in the public domain:
Clinical trials often involve large stakes and influential people and
therefore data collection of such trials become a difficult task, and because
of this breaches in the trial are not highlighted which increase the ethical
concerns due to non disclosure.

3. Problem with the Ethics Committee:

The requirement of formation of ethical committee is mostly not followed

and even when it is followed, it lacks the requisite training and qualification
required to fulfill the requirement and objective of formation. When the
governing body will not be fullh equipped with the requisite knowledge
then how the problem can be solved.

4. Principles of Beneficence – Do not harm:

The ethical principle of beneficence refers to the Hippocratic "be of benefit,

do not harm". If the research findings prove that it was not beneficial as it is
expected, this can raise immense ethical considerations.36 Beneficence
relates to the benefits of the research, while non-malificence relates to the
potential risks of participation".37The principle of beneficence includes the
professional mandate to do effective and significant research so as to better
serve and promote the welfare of our constituents".38Beneficence is
sometimes difficult to predict when creating a hypothesis especially in
qualitative research.

5. Respect for Anonymity and confidentiality:

The issue of confidentiality and anonymity is closely connected with the rights of
beneficence, respect for the dignity and fidelity. Subjects must not be made the point
of highlight they wish to avoid. Anonymity is protected when the subject's identity can

36
Carr L. The strengths & weaknesses of quantitative and qualitative research. What method for
Nursing? Journal of Advanced Nursing, 1994;pp- 716-721.
37
Ford L., Reutter L. Ethical dilemmas associated with small samples. Journal of Advanced Nursing,
1990;15, 187-191.
38
Beauchamp T. L. & Childres, J. F Principles of Biomedical ethics, 5th ed, Oxford University Press,
Oxford, 2001.
 not be linked with personal responses. The researcher is responsible to "maintain
confidentiality that goes beyond ordinary loyalty".

6. Respect for privacy:

Privacy is the vital part of a person’s esistence so much so that that in India recently a
long and much talked about decision have been given by Supreme court of India, In
K.S. Puttaswamy case recognizing Privacy as a fundamental right in India under
Article 21 of the constitution of India.39Privacy is the freedom an individual has to
determine the time, extent, and general circumstances under which private
information will be shared with or withheld from others ". 40 This may even apply to
report of age, income, marital status, and other details that the subject may regard
intimate. They also imply that privacy can be invaded when researchers study certain
groups without their knowledge and without identifying themselves.

7. Protecting interest of vulnerable groups of people:

In India the rights of the vulnerable group of people are highly at risk. Nowadays,
there is an increased concern about vulnerable groups and whether it is ethical or not
for them to be used as research subjects." Vulnerability is one characteristic of people
unable to protect their own rights and welfare".41 So, vulnerable groups include captive
populations (prisoners, institutionalised, students etc), mentally ill persons, aged
people, children, critically ill or dying, poor, with learning disabilities, sedated or
unconscious. However, the potential improvement of their nursing care raises the issue
of careful consideration before rejecting or accepting this kind of research.

8. Skills of the researchers:

Careful choice of method for data collection, to ensure validity and
reliability, are two main requirements that must be met in all kinds of
research. The choice depends on the object of the study. When human
beings are involved, all the ethical issues, discussed above, must be taken
into account. Amateur researchers should work under qualified supervision
39
(2017) 10 SCC 1
40
Levine. Preliminary Papers prepared for the commission, The Belmond Report, DHEW Publication,
Washington DC, 1976.
41
Fisher C.B. Integrating science and ethics in research with high risk children and youth. Social Policy
Report, 1993; Vol. VII.
 which has to be reviewed by an ethics committee.

9. Violation of Human Rights:

There are a lot of aspects of human rights which are at risk of being
violating in such trials and therefore all the issues mentioned above
manifest into culminating into major issue of Human Rights which are in
most of the trials violated and therefore steps must be taken in order to
sustain and maintain them intact.
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN
SUBJECTS

To address all the issues as mentioned above the, The Indian Council of Medical
Research has laid down the ‘Ethical Guidelines for Biomedical Research on Human
Subjects’ in the year 2000 which were revised in 2006. It gives twelve general
principles to be followed by all biomedical researchers working in the country. The
Ethics Committee stands as the bridge between the researcher and the ethical
guidelines of the country. The basic responsibility of the Ethics Committee is to
ensure an independent, competent and timely review of all ethical aspects of the
project proposals received in order to safeguard the dignity, rights, safety and well-
being of all actual or potential research participants. These are a set of guidelines
which every researcher in India should follow while conducting research on human
subjects. These guidelines have elaborated the three basic ethical principles: respect
for person, beneficence and justice by inducting twelve general principles as follows:

1. Principle of Essentiality:

Without an objective research is useless. The research being carried out should be
essential for the advancement of knowledge that benefits patients, doctors and all
others in aspects of health care and also for the environment and ecology well
being of the planet.

2. Principle of Voluntariness, Informed Consent and Community Agreement:

The research participant should be aware of the nature of research and the probable
consequences of the experiments and then should make a independent choice
without the influence of the treating doctor, whether to take part in the research or
not.
3. Principle of Non- Exploitation: Research participants should be remunerated for
their involvement in the research or experiment. The participants should be made
aware of all the risks involved irrespective of their social and economic condition
or educational levels attained.

4. Principle of Privacy and Confidentiality:

All the data acquired for research purpose should be kept confidential to prevent
disclosure of identity of the involved participant and should not be disclosed
without scientific reasons and/or valid legal.

5. Principle of Precaution and Risk Management:

Due caution and care should be taken at all stages of the research and experiment
(from its beginning as a research idea, formulation of research design/ protocol,
conduct of the research or experiment and its subsequent applicative use) to
prevent research participant from any harm and adverse events. EC has to play an
active role in risk minimization.

6. Principle of Professional Competence:

The researchers must be well equipped with the required expertise for the research.
Clinical research should be carried out only by competent and qualified persons in
their respective fields.

7. Principle of Accountability and Transparency: The researcher should conduct

experiments in fair, honest, impartial and transparent manner after full disclosure
of his/her interests in research.

8. Principle of Maximisation of Public Interest and of Distributives Justice:

The objective of research must be maximization of public interest, which should

benefit all humans especially the research participants.

9. Principle of Institution Arrangement

10. Principle of Public Domain:

Even before publication, the detailed information of clinical trials should be made
public before start of recruitment via clinical trial registry systems that allow free
online access like: www.ctri.in/; www.actr.au/; www.clinicaltrial.gov/or
www.isrctn.org/.
11. Principle of Totality of Responsibility:

Liability upon the people in charge of trials are important to ensure proper
functioning of the trials.

12. Principle of Compliance:

For research to be conducted ethically , these twelve general principles laid down
by the ICMR must be followed to avoid any ethical issue mentioned in the starting
of the chapter .

CHAPTER 5 : JUDICIAL OUTLOOK OF CLINICAL TRIALS

Clinical research has become globalized. As discussed in the preceding chapters that
because of the higher cost, the strict regulations, extensive safety and compensation
requirements, and a small population of developed countries, many trials are now
taking place in developing countries such as India, China, etc. India has been
recognized as one of the most promising hubs for clinical trials due to the high
availability of treatment- naive patients, lower cost, and large numbers of qualified
professionals.
In 2005, India amended its patent law in compliance with WTO and since then, in
order to promote clinical trials, the government has been trying to make changes in
the regulatory framework. However, many multinational companies took advantage
of India's favorable regulatory systems by enrolling a large number of illiterate and
poor subjects without obtaining adequate informed consent and hence, many unethical
trials took place. Many issues were raised by media and health activists and therefore,
the Supreme Court halted the approval of clinical trials until the regulatory framework
was updated. In this chapter various such controversial trials and the courts outlook
on such trials along with the changes in such trials will be discussed.
The issue of unethical trials and non compliance of the regulatory requirement have
been raised several times in the country. As a result of these unethical clinical trials,
nongovernmental organizations (NGOs), and media activists in the country have
raised many issues over the years. Most of the cases have not reached the courts due
to the involvent of influential people in such trials and non awareness amongst people
of their rights. Meanwhile, in 2013, the Supreme Court in India expressed serious
 concerns over clinical trials by acknowledging the gaps in the existing regulatory
framework by halting the approval of new trials until the laws and regulations were
updated.42 This prompted the CDSCO, the regulatory agency of India, to fix the
loopholes relating to execution and approval of clinical trials to protect the rights and
welfare of Indian citizens and to keep a check on such trials.

The clinical trial business in India responded to this pressure by scaling down
operations.43 Companies also moved some of their business to other Asian countries,
while there were many uncertainties regarding regulations, and while clinical trial
approvals were halted in India.

CONTROVERSIES WITH THE CERVICAL CANCER SCREEENING

CLINICAL TRIALS44
HPV vaccine is one of the most talked about controversies in the literature of clinical
trials. HPV vaccine research project was launched in Andhra Pradesh and Gujarat in
2009 The project wanted to calculate the cost and feasibility of including HPV
vaccines to the country’s vaccine program. The project was conducted by Path and
was funded by the Bill and Melinda Gates Foundation. 24,000 adolescent girls
between 10 and 14 years old were given the vaccine Most of the girls who
participated were tribal. Human rights organizations reported unethical conduct
during the project. Informed consent was not obtained from the parents of the girls.
Girls thought it was compulsory to participate in the trials. Girls suffered from
adverse effects e.g. dizziness, fatigue, weight loss, menstrual problems; Adverse
effects were not reported and 7 girls died. The HPV vaccine trial brought major
changes in India. After the death of seven girls, health activists and media
representatives asked the ICMR to respond to all the unethical trials conducted in the
country.

42
Bagcchi, S. (2013). Indian Supreme Court halts approval of new clinical trials until regulatory framework is
set up. British Medical Journal News, 347(f5996).
43
Kondal, A., Krishna, G.V.M., & Bansal, D. (2016). Clinical trial regulations in India: progress and challenges
arising from recent amendments to Schedule Y of the Drugs and Cosmetic (D&C) Act 1940 (D&C Rules 1945),
30, pp.1-13.

44
http://ijme.in/articles/concerns-around-the-human-papilloma-virus-hpv-vaccine/?galley=html
LANDMARK JUDICIAL DECISIONS MAKING THE BASE FOR THE
PRESENT LEGISLATIONS AND ENUMERATING GUIDELINES FOR THE
SYSTEMATIC CONDUCT OF CLINICAL TRIALS

The below are the landmark decision in the sector of clinical trials shaping the present
legislation on the subject.
SWASTHYA ADHIKAR MANCH AND ORS. v. UNION OF INDIA (UOI) AND
ORS.45

This case is one of the important case which changed the process of conducting
clinical trial in India and had a great impact on the conduct if clinical trials in the
country. The petition was filed by the non-governmental organisation Swasthya
Adhikar Manch (Health Right Forum), which advocates issues related to health rights
in India, seeking directions for the regulation of clinical trials involving new drugs
and chemical entities.
CONTENTIONS

The petitioner contended that 3458 deaths and 14!320 serious adverse events
occurred from January 2005 to December 2013. Many of those affected were still
awaiting compensation. The expert committee appointed by the government to
examine adverse events and deaths during clinical trials used a compensation formula
that assigned participants a risk factor rating on a scale of 0.5 to 4.0. This rating
showed the seriousness and severity of the disease being investigated, how long the
participant had had the disease, and the presence of any comorbidities. For
participants whose expected mortality (within 30 days) was 90% or more, the
committee recommended a fixed amount of Rs2 lakh [200#000 rupees] for a clinical
trial related death.

How compensation was calculated also needed to be reviewed, adding that the
formula should take account of income and dependents and should be part of the
information provided during the consent procedure of a trial. The amount of
compensation paid should also be the same wherever in the world participants lived.

Despite official figures on harms caused by clinical trials, the government affidavit in
the court reported that around 11#972 serious adverse events (excluding deaths) were

45
MANU/SC/1156/2013
recorded from 2005 to 2012, of which 506 related to clinical trials.
Based on the deliberations, the Secretary, Ministry of Health and Family Welfare
summed up and made the following observations:
“A). Even though the concerns have been raised about the conduct of clinical trials in
the country, clinical trials are necessary or the development of new drugs in the
country. India has the capacity and knowhow for drug discovery research. However,
there should be a robust system for conducting clinical trials in the country to ensure
that trials are conducted in a scientific and ethical manner and in compliance to the
regulatory provisions.

B). Restricting clinical trials to Government Hospitals alone would not provide a
solution. What is required is a robust system for regulating the conduct of clinical
trials in the country.
C). The amount of money paid by the sponsor/companies to the investigator for
conduct of clinical trial may act as an inducement to the investigator for conducting
clinical trials. Sometimes such inducement may lead to bias in enrollment of subjects
in the trials.
D). Regulatory provisions may be made so that information relating to the amount of
money paid by the companies to investigators for conduct of clinical trials is in the
knowledge of the regulatory authorities.
E). There are some concerns on certain clauses of the amendment of Drugs &
Cosmetics Rules regarding compensation in clinical trials. Some amendments in these
clauses may be required.
F). A Committee constituted under the chairmanship of Dr. Ranjit Roy Chaudhury for
formulating guidelines on clinical trials and new drugs has submitted its report. The
report will be helpful in further strengthening of the Regulation of clinical trials in the
country.

G). States' suggestions and views would be considered for further strengthening of the
Regulation of clinical trial”.46
It was further stated in the additional affidavit of the governement that 577 clinical
trial sites have been inspected and notices have been issued to the
investigators/sponsors/ethics committees seeking clarifications in 235 cases.
46
MANU/SC/1156/2013
 DECISION

The Supreme Court of India told the government that applicants seeking approval to
conduct clinical trials must be asked to provide a risk-benefit assessment of the drug
being investigated, its potential benefit to patients, and the advantages it offers over
existing treatments.
The court restrained the Central government from giving permission for clinical trials
of new drugs without putting in place a proper mechanism to regulate such trials in
the country. The court banned clinical trials for new chemical entities unless they
were personally vetted and cleared by the health secretary. The court stressed on the
setting up of a proper mechanism for monitoring clinical trials in the country and also
asked the government not to allow trials for untested medicines.

IMPACT OF ORDER

After the order , in two months, the ministry approved 157 trials, prompting the court to
ask it on for the basis for doing so. The Supreme Court of India directed the health
ministry to review the approvals granted to 157 clinical trials cleared by the country’s
drug regulator in less than two months, increasing the uncertainty faced by a $500
million industry.47 The health ministry now has to re-evaluate these trials, “particularly
in terms of assessment of risk and benefits for patients, innovations to existing
therapeutic options and benefits to medical needs of the country. For six months after
the order, the health ministry didn’t approve any trials. Agencies such as the US
National Institutes of Health cancelled nearly 40 clinical trials in India because of the
uncertain regulatory environment. Several drug makers moved their trials to other
locations.

COURTS ON INFORMED CONSENT

In V.P. Shantha case,48 the Supreme Court had an occasion to remark whether the
doctrine of informed assent could be applied in India at all and the Court said 49 “In
India, majority of citizens requiring medical care and treatment fall below the poverty
line. Most of them are illiterate or semi-literate. They cannot comprehend medical

47
https://www.livemint.com/Industry/XQvYs3BcDWU3nZ95ZEaeaL/SC-directs-health-ministry-to- reexamine-
157-clinical-trials.html
48
AIR 1996 SC 550
49
Supra Note 48
 terms, concepts, and treatment procedures. They cannot understand the functions of
various organs or the effect of removal of such organs. They do not have access to
effective but costly diagnostic procedures. Poor patients lying in the corridors of
hospitals after admission for want of beds or patients waiting for days on the roadside
for an admission or a mere examination, is a common sight. For them, any treatment
with reference to rough and ready diagnosis based on their outward symptoms and
doctor's experience or intuition is acceptable and welcome so long as it is free or
cheap; and whatever the doctor decides as being in their interest, is usually
unquestioningly accepted. They are a passive, ignorant and uninvolved in treatment
procedures.”

The court further stated that , “The poor and needy face a hostile medical environment
inadequacy in the number of hospitals and beds, non- availability of adequate
treatment facilities, utter lack of qualitative treatment, corruption, callousness and
apathy. Many poor patients with serious ailments (e.g. heart patients and cancer
patients) have to wait for months for their turn even for diagnosis, and due to limited
treatment facilities, many die even before their turn comes for treatment. What choice
do these poor patients have? Any treatment of whatever degree, is a boon or a favour,
for them. The stark reality is that for a vast majority in the country, the concepts of
informed assent or any form of assent, and choice in treatment, have no meaning or
relevance. The position of doctors in government and charitable hospitals, who treat
them, is also unenviable. They are overworked, understaffed, with little or no
diagnostic or surgical facilities and limited choice of medicines and treatment
procedures. They have to improvise with virtual non-existent facilities and limited
dubious medicines. They are required to be committed, service oriented and non-
commercial in outlook. What choice of treatment can these doctors give to the poor
patients? What informed assent can they take from them?”50 It is clear that “due to the
constant reliance on the Bolam principle (Bolam v Friern Hospital Management
Committee, 1957).51 This case declined any request of the informed assent doctrine
in the UK and instead reaffirmed the paternalistic attitude that courts had towards the
medical profession. The primary reason for the Supreme Court’s paternalistic and
protective attitude towards doctors and the medical profession seems to be due to the
50
AIR 1996 SC 550
51
1957 1 WLR 582
 nature of polity and society in India. India has a large patient pool and most of them
are poor and illiterate.

Hence it would be a duty of law to put an obligation on the doctors to follow the
doctrine of informed consent. Even if doctors were made obligatory to follow the
informed consent, such obligation would be meaningless because the patients would
not be able to understand the risk associated with a particular clinical procedure

In Kalpana Mehta and Ors. vs. Union of India (uoi) and Ors52 the Petitioners allege
that the process of licensing vaccines to prevent cervical cancer was not preceded by
adequate clinical trials to ensure the safety and efficacy of the vaccines. Nearly
twenty four thousand adolescent girls are alleged to have been vaccinated in Gujarat
and before its bifurcation, in Andhra Pradesh without following safeguards. The
petition calls into question the role of the Drugs Controller General of India and the
Indian Council of Medical Research. The administration of the vaccine is alleged to
have resulted in serious health disorders. Deaths were reported. The Supreme Court
ordered the Centre to formulate with rules to regulate clinical drug trials on humans
by pharmaceutical firms. The court added unregulated clinical trials have a “serious
impact” on people’s health.

In Systopic Laboratories (Pvt.) Ltd v. Dr Prem Gupta 53 Issues was regarding validity
of notice issued by Government of India after containing that long term use of
steroids in fixed dose for treatment of asthma involves risk to human beings so it is
necessary to prohibit manufacturing and sale of said drugs , the respondent contended
that the expert committee did not direct the clinical trials so the ban cannot be
justified to which the court held that

DECISION

52
MANU/SC/0519/2018
53
AIR1994SC205
 The court stated that , “As to whether clinical trials should have been conducted or
not was primarily for the experts to decide and if the experts felt that in respect of the
drugs in question such clinical trials were not necessary, it is not possible to hold that
there has been no proper evaluation of the material that was submitted by the
manufacturers before the Experts Committee."54 hence notice was validly issued in
respect of public interest and it was held held, validity of notice cannot be questioned.

In Bayer Corporation & Anr vs Union Of India & Ors,55 the court stated that in the
event that the drug in question has already been approved by the competent authority
of a foreign jurisdiction, the published toxicity report and clinical trial data (Phase I
and Phase II) as submitted in the said foreign country can be annexed with the
application and a waiver can be sought by the applicant from actually conducting the
same Phase I and Phase II trials/studies in the country. However, except when it
comes to drugs for life threatening diseases like cancer/HIV, Phase III clinical trials
are required to be conducted in India. When the drug for which approval is being
sought is not approved in any other foreign country then the applicant has to
necessarily perform and provide toxicity data and Phase I, Phase II, Phase II clinical
trial data to the DCGI.

In Jacob Puliyel vs. Union of India and Ors.,56 the court stated that public disclosure of
the data before the phase IV of trials in not mandatory.

In Unichem Laboratories Ltd., Bombay & another Vs. Union of India,57 in Roussel
Pharmaceuticals (India) Ltd. Vs. Union of India,58 and in Lundbeck India Private
Limited vs Union Of India59 the courts discussed the rules and guidelines enumerated
in schedule Y and stated that they are to be complied with but when they were
challenged they did not put compete embargo on the sale of such drugs and they were
permitted subject to restrictions.

54
AIR1994SC205
55
MANU/DE/1756/2010
56
MANU/DE/3058/2015
57
AIR 1988 Bombay 134
58
1989 (42) ELT 374 (Bom)
59
MANU / KA / 1498 / 2013
 In Warner Hindustan Ltd. vs. Collector of Central Excise, Hyderabad, 60 court held that
“for any formulation to be considered as Ayurvedic medicine, the same should be
either recognised so in a standard Ayurvedic work or should be so prove`d
by clinical trials or should be recognised so by an authority like DGHS, thereby this
proves the acknowledgment and importance of clinical trials”.

In Roche Products (India) Pvt. Ltd. Vs. Drugs Controller General Of India 61 It was
stated that , “pursuant to the notification No.F.No.12-01/09-DC-(Pt-32) issued by
DCGI which was effective from June 15, 2009, registration of all phases of a clinical
trial with the Clinical Trials Registry-India (CTRI) is mandatory prior to the initiation
of any such clinical trial.”

Therefore the above mentioned cases are example that the courts have acknowledged
the schedule Y of the Drugs and Cosmetic Rules, 1945 as an important piece of
legislation regulating clinical trials and in have also tried to evolve and regulate these
trials through its decisions.

REGULATORY CHANGES

The Supreme Court decision in Swasthya Adhikar Manch and Ors. Vs. Union of
India and Ors.62 prompted the CDSCO and Ministry of Health and Family Welfare to
tighten the mechanism of clinical trials by enacting strict laws and regulations.
Therefore, three new Rules were introduced in Schedule Y, namely Rule 122DAB,
Rule 122DAC, and Rule 122DD63 dicussed in the previous chapter, in 2013.

Based on recommendations given by Prof. Ranjit Roy Chaudhury Expert Committee,

the CDSCO signed several other rules on July 3, 2014 to further strengthen the
regulatory framework, (CDCSO, 2013). There have been three amendments in
Schedule Y of the Drugs and Cosmetics Act. The first being the insertion of Rule 122
DAB which specifies procedures to analyze the reports of SAEs occurring during
60
MANU/SC/1016/1999
61
MANU/DE/2300/2015
62
MANU/SC/1156/2013
63
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4290669/
 clinical trials and payment of compensation in case of trial related injury or death as
per defined timelines. The detailed process is described by addition of Appendix XII in
Schedule Y. The second with insertion of Rule 122 DAC which specifies conditions
under which application for conduct of clinical trials shall be approved by licensing
authority, which includes a very important point that the sponsors, their subsidiaries,
agents, sub-contractors, and clinical trial sites shall allow inspectors authorized by
CDSCO to inspect their premises. The third amendment is related to mandatory
registration of the Ethics Committees (EC) in the Drug and Cosmetic act, 1940 with
addition of Rule 122 DD.

IMPACT OF THE DECISIONS AND CONSEQUENT AMENDMENTS

The decisions of the court and amendment had an impact on the trials in Indian
because of the latest regulatory changes, the rate of clinical trials approval has been
affected. The increased numbers of regulatory submission, such as the sponsor's
affidavit to give medical management and remittance in the event of trial-related
injury, to market medicine in India after trial completion, annual reporting of the
study, and SAE reporting mechanisms—have resulted in prolonged approval
timelines.

In early 2013- 2014, after the establishment of three new rules, there was an
enormous decline in the number of clinical trial approvals. The decline was also
observed in the number of registered trials in India on ClinicalTrials.gov. 64Because of
these amendments, only six clinical trials were approved between January and March
2013 These data show that either the government is taking too long to review the
applications or industry is hesitant to conduct trials in India.

Clinical researchers required time to adapt to the new rules and regulations. From July
2013 to June 2014, the numbers of clinical trial approvals slowly increased. Because of
such uncertainty, several multinational companies have considered shifting their
business from India to other countries, such as China, Thailand, and Malaysia This
decline was continued in 2016 and also in 2017.65 The reason for this was the frequent

64
Kondal, A., Krishna, G.V.M., & Bansal, D. (2016). Clinical trial regulations in India: progress and
challenges arising from recent amendments to Schedule Y of the Drugs and Cosmetic (D&C) Act 1940
(D&C Rules 1945), 30, pp.1-13.

65
https://www.thehindu.com/news/national/after-a-lull-of-five-years-clinical-trials-on-the-rise-in-
india/article24069487.ece
 amendments in regulations, most troubling is a requirement for sponsors to
compensate trial participants in the case of adverse events or death, regardless of
whether the event was caused by the study drug or preexisting disease. These frequent
changes in regulations led to the increased confusion among clinical research
stakeholders.

DRUGS AND CLINICAL TRIALS RULES, 2019

The Union Ministry for Health and Family Welfare has notified the Drugs and
Clinical Trials Rules, 2019 with an aim to promote clinical research in the country.
The latest set of clinical trial rules, will have following impact:-66

 It will fast-track proposal clearances for Indian companies rather than their
multinational counterparts. The turnaround time for clearing clinical trial
proposals was not defined earlier, it is going to change once new rules take
effect.
 Proposals to be deemed approved if status is not intimated within 30 days.
 Indian companies will be provided incentive to start clinical trials and their
proposals will be deemed approved in case they do not hear from the Drug
Controller General of India (DCGI) on the status of their application within 30
days. DCGI has taken a leaf out of United States Food and Drug
Administration’s (US-FDA) workings while tweaking this rule.

While domestic approvals will be fast-tracked, for multinational pharma

companies, the waiting period will be defined mostly at six months in the
notified rules, which were framed in the hope that indigenous pharmaceutical
companies will boost drug research efforts. Earlier, pharmaceutical
companies, be it domestic or MNCs, had no clue as to when their paperwork
would be accepted by the DCGI. The new rules would boost indigenous
pharma research in India and help bring more global trials both from domestic
and MNCs
 A clause for pre-submission and post-submission meetings with pharma
companies. It will bring in more transparency, processes will be well-defined
and consultation will be allowed in a defined time frame. In the new rules,
66
https://www.gktoday.in/current-affairs/drugs-clinical-trials-rules-2019/
 DCGI has decided to change the compensation clause in case of death or
disability presumably caused by clinical trials. Earlier, the draft rules had said
60 per cent of the amount would be non-refundable, even if an expert
committee at a later stage found the death or disability was not related to the
clinical trial. Now the non-refundability clause has been done away with.
 The current rules , provide compensation to those enrolled in clinical trials
according to a set formula, when participants are reimbursed anywhere
from ₹4 lakh75 lakh, and that clause will be continued in the new rules as
well. Since 2015, close to ₹ 5 crore has been paid in compensation to those
enrolled in clinical trials, the Ministry of Health informed Parliament
recently.

Supreme Court decision to put a halt on clinical trials in 2013 was a turning point in
operation and conduct of clinical trials in the countryThis was the turning point in
India in terms of changes in the regulatory environment. After 2013, many laws and
regulations were changed in India, which leads to the reduced numbers of clinical
trials in the country. However this is also not goof for the country both in terms of
economic advantage as well as the medical advancement of the country and the
position of the country globally in this regard.

Therefore the government is trying to further make the present system of regulation in
terms of the global standard. The notification of 2019 was one of the step in
furtherance of the same where while respecting and safeguarding the interest of the
subjects the medical advancement of the country and advantages of clinical trials are
also considered in mind.

Current changes are good in terms of public safety, but still there are many loopholes
that need to be fixed. India has a potential to become a favorable destination in the
world for pharmaceutical companies because of its large patient population, low cost,
and skilled professionals. But at the same time, India still needs to do a lot to match the
international standards.
 CHAPTER 6 : SUGGESTIONS AND CONCLUSIONS

In the present research the researcher tried to study all the aspects of the clinical trial to
get the complete knowledge in regard to the research Hypothesis. The research
included the study of the concept of cinical trial, the legal and ethical issues involved
and attached to it, the present legislation on the subject and the advancement in the
same along with some controversial trials and judicial interpretation. It has come out
by this resarch that India is an emerging market of clinical trials and an attempt to
safeguard the interest of the human volunteers have been made time and again but
they have not been completely followed and applied which resulted in some adverse
consequences yet the country is trying to further amend and make the present
legislation in terms of the global standard but have not been completely successful in
this regard.We all understand that clinical trials are indeed essential for the progress
of medical science, but we can never justify the unethical and dishonest clinical trials
that take place in India. Without actually intending to do so, policy makers in India
have allowed participation in clinical trial to become something very close to job
which they are trying to rectify.

Payments made to subjects are often referred as compensation, to suggest they are
merely reimbursing the patients for their expense and inconvenience. In many cases,
subjects are not paid even for their expenses and inconvenience. Many interviews
show that these participants use the money from the trial to makes the ends meet and
it is their means of livelihood . Drug companies refer the paid subjects as volunteers,
implying that the participants are free to decide whether or not to take part in the trial
itself. This is a complete misconception because have validly stated that they have
taken up clinical trials only for sake of money. Regulators allow sponsors to use
money to attract subjects but these subjects do not get whatever they want. Money is
paid to the people, not to do something but just to endure the pain, and often they are
not reimbursed properly even for the pains that they have taken.

Chapter 2 of this thesis introduce the concept of clinical trial, its evolution in India
and discuss why India is emerging as an attractive destination for clinical trial.

According to this chapter global pharmaceutical companies based in developed

countries are increasingly turning to developing countries and emerging economics
around the world for conducting clinical trials. The main reasons for clinical
experimentation outsourcing are the reduced costs combined with easy availability of
patients with varied diseases. The chapter further illustrates the concept and clinical
trial process.

The legal issues surrounding the clinical trials is provided in chapter 3, where it is
discussed how certain regulatory framework, approval process liabilities have been
proved to be impediment in clinical trials and how they though are indispensible must
be revised in certain area.The main sources of statistics are used: current literature,
controlling and guidance documents, and reports by various organizations and
authorised websites of clinical trials”. It also enlightens about the ethics in clinical
trials and then discuss the ethical issues in conducting clinical trials. The chapter
throws light on the requirements of the ethical standards to be observed in such trials.

Chapter 5 discuss the judicial outlook of the clinical trials in the country and the way
the judiciary has looked upon the clinical trials in the country and its response to the
same. Unfortunately, there have been some isolated incidents of alleged unethically
and unregulated carried out trials and therefore the chapter deals with the recent
judicial trends in clinical trial litigations and also presents some case analysis where
unregulated clinical trial were reported.

Chapter 6 is the concluding chapter providing with the suggestions that can be used to
evaluate and enhance the governance of clinical trials at national level.

Clinical trial are very significant in the medical advancement of the country.
Innovation in medicine development is one of the most important components of
public physical health improvement. Clinical trials are the experimentation analysis
that explore whether a medical device, treatment or strategy is safe and effective for
humans or not. It is very complex endeavour which involves hundreds of steps that
must be taken, numerous decision points, and multi-layered and iterative review
processes because multiple supervisory bodies with different objectives and
responsibilities have jurisdiction over clinical trials.
Clinical trials in human is always preceded by an extensive trial in human cells or
animals and human are not first recipents of it. Clinical trials are not mainly intended
 for the direct benefit of the experimentation subjects. Researchers first test the safety
and secondly factors like proper dosage and side effects. In clinical trials, not all
experimentation subjects receive the test treatment; some receive an existing
treatment or a placebo, in order to make a comparison”. Drug and device testing start
with extensive laboratory experimentation which may involve years of experiments in
animals and human cells. If the initial laboratory experimentation is successful,
researches send the data to the authority which oversight the clinical trial for
acquiescence to continue experimentation and testing in humans.

The clinical trials are important to understand the efficacy of drugs and the result of
clinical trials has major impact on the medicine manufacturer’s interests and efforts
and also on prognosis of disease. Thus clinical trials are not only important to a
medicine company and patients but also to government, regulators, media, different
advocacy groups, ethical police, media, and the general public.

Various intermediaries who play important role in the conduct if clinical trial are
discussed in the research like investigators, sponcers, CROs. There are various actors
who play an important role in medicine and device discovery and clinical trials.
Physician investigator is one of such actors in the clinical trial process. Physician’s
role can be seen in both; success and failure of the clinical trial. Their primary
obligation is the care of their human experimentation subject. Various research
reports reviled that physicians look upon these clinical trials primarily as a lucrative
business venture.

Contract Research Organizations (CRO) is another group of actors who provide

clinical trial and other experimentation support services for the pharmaceutical,
biotechnology, medical device industries and also serve government institutions,
foundations and universities who are engaged in conduct of clinical trial. Pharma
companies are increasingly looking outsource critical functions, including
manufacturing and experimentation. They are using CROs to lead clinical trials and
develop recent medicines and devices.67

The government is responsible for controlling oversight of clinical trials. It not only
ensures that the medicines brought to market are safe and effective, but also that the
clinical trials are carried out in a manner that protects the rights and welfare of
67
https://www.thebalancesmb.com/contract-research-organizations-cro-2663066
experimentation subjects. Laws and rules governing clinical trials differ from nation
to nation, but standard clinical trials share important criteria such as respect for
subjects, strong scientific evidence, supervision by independent committees and
compliance with appropriate laws and rules concerning experimentation on human
subjects etc.
This thesis contributes to literature by providing balance between subject welfare and
innovation, rather than to focus separately on the protection of subjects and the need
to promote innovation in medicine development. “Broadly, this thesis contributes in
following ways:
• It provides literature history of the medicine development and ethical and legal
issues in conducting clinical trials;
• It provides a framework for evaluating policies and procedures for ethical conduct
of clinical trials in terms of their ability to reduce uncertainties;
• It details the relationship structure for interdependent decision making amongst the
various players involved in the clinical trials process; and
• It legal framework regulating such trials;
• It provides recent judicial trends in clinical trial litigations.

In order to understand why risk involvement is still a challenge in clinical trials, one
must first understand the complexities involved in the conduct of clinical trials and in
the protection of experimentation subjects. Therefore the thesis provide for the detailed
method of the clinical trials the legal and ethical issues invoved, the current judicial
trend and concludes with proving the suggestions to overe come those issues and
maintaining balance between the interest of the subjects and the medical advancement
in the country.
SUGGESTIONS

Following are some other changes recommended in the existing law, which be an aid
for the future in striking and maintaining balance between the interest of the subjects
and the growth of clinical trials in India:
• MAKING THE PRINCIPLE OF INFORMED ASSENT MORE STRICT
AND ITS COMPLIANCE MUST BE STRICLY OBSERVED

The area of the greatest concern relating to unethical practice is the informed assent
taking process and its documentation. This has led to strict rules being put forth to curb
such unethical practice. However, considering the diverse educational and social status
of our population, few trial subjects have the motivation or interest to go through the
statistics given in the patient statistics sheet of the informed assent documents despite
detailed discussion with them. It has been witnessed non observance of this principle
in many trials. It is also difficult for a trial subject to enlist the name of the
nominee(s) in the informed assent form. This will overtly or covertly lead to
investigators giving a preference for including a literate research population, which
goes against the principle of natural justice. 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 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.

population, which goes against the principle of natural justice. 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 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:

If the people having control and charge of the clinical trial are made liable for every
fault in the trial without considering the circumstances involved it will become
difficult to take the clinicl trial in hands. Restricting the liability of the sponsors to the
injury or death of the subject which are resulting directly, indirectly or sufficiently
attributable to the participation of the subjects in the clinical trials can be a way to
increase the number of trials in India. The timelines for payment of compensation
should be liberalized depending upon the case to case basis and the factual difference
must be given importance to. 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

There are certain trials which are not bring into the notice of the public. Independent
experimentation 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 experimentation 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 experimentation organizations must
be under the constant watch of the concerned authoriries and implementation of the
same should be ensured.

• APPROVAL MECHANISM

The approval process require certain changes. Fast and time efficient acquiescence
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 acquiescence time for initiating medicine trials in India typically runs from six to
eight months, compared to 30 days in Europe and Canada. This has been though
addressed by new rules of 2019, but how much they will be effective and applied will
depend on the functioning of the authorities.
• TRANSPARENCY:

Public disclosure at regular intervals must be made mandatory. 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 the kind of investigation, standard of care taken,
subjects involved, etc.

• CHANGES IN THE INSPECTING OF THE TRIALS

The trial sites must be officially and regularly inspected. Officials of the 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 controlling authority to investigate the
matter more efficiently.

• RELAXATION IN CERTAIN LAWS:

Respect must be given to the laws of other countries as well. Multi-national

corporations which are voluntarily following the internationally recognized
instructions 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 controlling
atmosphere for coming to India and carrying out clinical trials for advancement of the
clinical trial industry in the country.

• DRUGS WITH SERIOUS SIDE EFFECTS

All trials must not to weighed as similar and disparity in these trials must be
acknowledged. It is seen that most of the deaths occurred in the past few years is due
to some specific medicines 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 medicines and only in exceptional cases and depending upon
the utility of such medicine the permission should be given.

• ROLE OF MEDIA

Media plays very important role in all the aspects of the society. 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. Negative publicity discourages the sponsor and creates uncertainties in the
mind of the subjects. Regular checks of media broadcast must be done. Rather media
should emphasize on spreading awareness about such clinical trials targeting the
vulnerable sections who mostly get involved in trials as subjects. A separate authority
with suitable powers, to keep surveillance of the same must be out in picture.
Trained staff with maximum awareness in the field. , Maximum help from the
government. ,Encouragement of local pharmaceutical companies., Encouraging well-
equipped clinical trial centers, Bringing the legal standards close to the International
level, Following the bioethics strictly can be some of the steps to create a balance in
the trials and interest of society. Thus there is still a long way to go in resolving all
the issues and at no stage the last and final word can be said.

Therefore though India has regulatory guidelines and legislation yet the trials studied
and discussed in this dissertation directed towards the non compliance of such
regulations and therefore the need to rectify the loopholes in such regulation and
constant check on their implementation are important. There is a need to put the
legislation in India at the same level as that of developed nations.

The above mentioned suggestions are to respect both the importance of clinical trial in
the country as well as the interest of society and volunteers involved. The ethical
concerns of the clinical trials cannot be removed completely. But the above
suggestions, if implemented, can certainly give bright prospect to the growth of
clinical trials and experimentation in the physical health care sector in India and
would help in regaining the lost confidence of the multi-national corporations
interested in carrying out clinical trials in India.” Law should be for the regulation of
the clinical trials and not for restricting the clinical trials!