INTRODUCTION: DELVING INTO THE NEED FOR THE CLINICAL TRIALS AND THE

LEGISLATIONS CIRCUMVENTING IT IN THE ARENA OF LAW

India has drastically emerged as a favoured developing country for global clinical trials in the
status quo due to its ability to significantly lower trial costs, by as much as 60 percent, owing
to affordable labour, reduced infrastructure expenses, and easier availability of participants. 1
In the early 2000s, with growing policy backing from the Indian government, the global
pharmaceutical sector saw India as an attractive destination for conducting clinical research.

A report by the Dutch non-profit organization SOMO states that India has “the fastest
recruitment rates for clinical trials worldwide.”2

Speaking generally, clinical trials refer to the research studies conducted to evaluate the
safety, efficacy, and side effects of new drugs, medical treatments, and vaccines before they
are approved for public use. Any newly developed drug, medical device, or treatment
regimen must not only be effective in addressing a specific disease but also safe for human
use. The evaluation of both safety and efficacy is carried out through “clinical trials”. Clinical
trials are the bridging link between the pre-clinical drug discovery and its eventual usage in
the biomedical sphere.

Since these trials aim to answer unresolved questions about new treatments, they are
considered “research studies”. To ensure patient safety and generate reliable results, clinical
trials must adhere to strict scientific standards. Clinical trials are of cardinal importance in the
advancement of the biomedical research in the world as well as from the ethical optics. A
new drug for human use cannot be utilized until the clinical trial through various phases is
carried out effectively.

There are mainly four kinds of clinical trials. They are divided into four phases as mentioned
below:

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a) Phase 1 Trials- Clinical trials are first conducted on a small group of healthy volunteers
to determine a safe dosage, assess potential side effects, and study the drug's
pharmacokinetics, including its absorption, distribution, and elimination from the body.
b) Phase 2 Trials- These trials are conducted to evaluate a drug's effectiveness against a
specific disease, gather additional data on potential adverse effects, and determine the
optimal dosage for maximum efficacy.
c) Phase 3 Trials- These large-scale trials involve thousands of patients across multiple
treatment centres, such as hospitals and other clinical laboratories. They may assess an
alternative route of administration, a different dosage of an existing drug compared to the
standard regimen, or evaluate a new drug against the established treatment for a specific
condition. This phase is also the most expensive amongst all the phases.
d) Phase 4 Trials- These trials are conducted after a drug has been proven effective and
approved for only a specific clinical condition. Their primary objectives include
assessing long-term risks and benefits, identifying potential new medical uses for the
drug, and gathering further data on its side effects and safety.

“The clinical trials in India are governed by the following regulations:

1. Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945
2. New Drugs and Clinical Trials Rules, 2019
3. Indian Council of Medical Research (ICMR) Guidelines
4. Ethics Committees and Institutional Review Boards (IRBs)

The Drug Controller General of India (DCGI) is the apex body that oversees approvals,
while the Ethics Committees ensure that trials are conducted ethically and in compliance with
global standards and as per the best practices.”

A review of unethical clinical research in India reveals that before 2005, there were only a
few recorded cases of studies conducted without informed consent. However, after the rapid
expansion of the clinical research industry post-2005, concerns over regulatory issues in
India's clinical trial framework began to surface. Many commentators questioned the ethical
standards of certain trials. Between the years 2000 and 2010, both Indian and international
media reported several instances where participants were enrolled in trials without proper or
any consent.
Through this research paper, the researchers have attempted to dissect the aforementioned
case ruling that was rendered by the Supreme Court of India and shed light on the
jurisprudential development of the phenomenon of clinical trials from the concern of the
Indian perspective.
 BACKGROUND AND FACTS OF THE JUDGEMENT

BACKGROUND OF THE CASE:

The Swasthya Adhikar Manch v. Union of India has been a prominent case filed as public
interest litigation and it brought to light the serious problem of lack of strict regulation and
rules for governing clinical trials in the country. The case also exposed how the population of
the country which are economically disadvantaged have been used for the purpose of clinical
trial without giving proper information to them to make an informed decision. And hence the
consent was not informed consent subsequently leading to them facing severe effects
associated to health and even death of a lot of people. This case led to a lot of work by
government and subsequently there were regulatory gaps in the law which were tried to be
filled through rules governing clinical trial in the country.

India saw a prominent growth as being the favoured destination for a lot of companies and
contract research organisations for outsourcing or to do clinical trials. The reason of this was
that India has a large and a very diverse genetic pool with the increased population and also
the cost of such experimentation is lower and the regulatory mechanism is very weak or there
was no regulation statutorily as such. This led to wide spread exploitation of people specially
the poor and the illiterate population.

FACTS OF THE JUDGEMENT:

A number of clinical trials were conducted without proper informed consent being taken from
the people that participated. And in some instances the people were not even aware that they
were being part of a clinical trial. In some cases the people who were tested by the drug were
not even suffering from such a disease and in case of any injuries or even death due to the
trial there was inadequacy in compensation or it was totally absent.

Investigations by different civil society institutions and reports from the reporters revealed
these realities. The reports indicated direct connection between the death and injuries with the
drug clinical trial. A number of whistleblowers and activist started raising their voice against
these unethical clinical trials and propagating for a stringent and strong regulation to govern
them. Finally a NGO which was based in Indore called the Swasthya Adhikar Manch which
basically focused on the health rights filed the PIL in Supreme Court in 2012.

The petitioner(s) herein were Swasthya Adhikari Manch as well as other organisations and
the respondents were Union of India, The Drug Controller General of India and other
regulatory bodies. The main issue central to the case was unregulated clinical trials that took
place and affected the vulnerable population of the country violating the ethical guidelines
and legal provisions.

ISSUES PERTAINING THE CASE

The following issues were being considered by the court in the present case at disposal:

a) Whether clinical trials in India were conducted in a way that infringed upon individuals'
fundamental rights, particularly their Right to Life under Article 21 of the Constitution.
b) Whether regulatory bodies, such as the Drug Controller General of India (DCGI), failed
in their responsibility to enforce legal and ethical standards in clinical trials.
c) The adequacy of informed consent, transparency, and ethical supervision in trials
conducted by pharmaceutical companies.
d) The need for stricter regulations and enhanced monitoring mechanisms to safeguard
human rights in clinical research.

ARGUMENTS PRESENTED FROM THE PETITIONER’S SIDE

The petitioners presented various arguments highlighting in detail the important concerns to
be taken into consideration due to the lack of regulation of legal trials in India and their
conduct

They contended that the present framework of regulatory mechanism is insufficient and does
not effectively oversee clinical trials. This has led to lot of an unethical practices which have
compromised the safety of the participants leading to emergent need of stringent regulation
and effective enforcement for the ethical conduct of such clinical trials.
There is also no clarity regarding the accountability for approval and monitoring such trials
with transparency. It was also highlighted about the absence of crucial information by drug
companies regarding the clinical trials like of the protocols to be followed and the adverse
events that could take place and other information was prevented from public dissemination
and awareness and this allowed propagation of an unethical practices contrary to law.

There was also absence of proper guidelines and mechanism to provide compensation to
participants injured or suffering adverse effects which affected a lot of people and families
with no records available making there conditions more severe.

Petitioners also contended that the clinical trial did not followed the guidelines stated in
schedule Y of the Drugs and Cosmetics Act 1940, and this non-compliance has resulted in
severe consequences and undermining the position of clinical research in the country.

ARGUMENTS PRESENTED FROM THE RESPONDENT’S SIDE

The, respondents, that is, the Union of India maintained the government's stance on the
conduct of clinical trials in India on behalf of regulatory bodies such the Ministry of Health
and Family Welfare and the Drug Controller General of India (DCGI). One of the first
arguments made by the respondent was regarding the regulatory framework of carrying out of
the clinical trials in an ethical manner. The government argued that the Drugs and Cosmetics
Act of 1940, the Drugs and Cosmetics Rules of 1945, and the guidelines published by the
Indian Council of Medical Research (ICMR) governed clinical trials in India.

The respondents contended that there were adequate legislative safeguards in place to
guarantee the moral and secure conduct of clinical trials.

Another pivotal argument made from the side of Union of India was that, according to the
government, an Ethics Committee, which was in charge of protecting the rights and welfare
of trial participants, had to approve each clinical experiment. It was noted that the Central
Drugs Standard Control Organization (CDSCO) is responsible for making sure that trials are
properly supervised and tracked.

Additionally, it was maintained by the defendant’s side that clinical studies conducted in
India complied with international ethical standards, which include getting subjects' informed
consent prior to enrolment. Any departures from these procedures, according to the
administration, were one-off occurrences and did not represent structural flaws.

Although there had been accusations of misconduct on the part of the governmental bodies,
the respondents contended that there was insufficient proof to establish a pervasive violation
of fundamental rights guaranteed by Article 21 of the Constitution. 3 They insisted that
oversight was being improved and ethical issues were being actively addressed by regulatory
agencies.

The administration also claimed to have already implemented changes to improve the clinical
trial regulations in response to the concerns raised about unethical behaviour. It referred to
changes and new regulations, including as more stringent approval procedures, improved
oversight, and procedures for compensating trial participants who suffered injuries.

Lastly, the defendants also put forth the argument before the court that in order to improve
public health by providing patients with novel and efficient therapies, the respondents
underlined the significance of clinical trials.

They also emphasized how India's participation in clinical trials aided in the development of
science and the expansion of the pharmaceutical industry's economy.

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 JUDGEMENT RENDERED BY THE COURT

In response of these concerns that were put forward in front of the court the court issued
several directives for the purpose of three forming the framework of clinical trials in the
country. To court directed to strengthen the regulatory framework of the clinical trials in the
country. Just made the government to appoint an expert committee on urgent basis which
would be recommending improvements in the regulatory rules.

Also subsequently to this decision of the court the drugs and cosmetics amendment Bill 2013
was passed which made changes in the legislation in terms with the recommendations of the
expert committee. This included the changes in terms of stricture penalties for non-
compliance and strict guidelines to be followed.

Persuant to this case the court also directed establishment of a committee at Apex (central)
level and also a technical committee which will help in supervising the conduct of clinical
trials and ensuring the safety of the participants with ethical standards being maintained.

Proper guidelines given clarity about the compensation to be paid to the participants in the
clinical trial in case of any injuries or any death. These should also ensure timely and
reasonable time for redressal of complaints regarding such issues. To maintain transparency
and accountability the code also asked all the contract research organisation to be registered
with the government one urgent basis.

The code also Abhay the importance of obtaining proper and clear in formed consent from all
the participants in the clinical trial after they have all the required information. And made
other guidelines and additional measures for the safety of more valuable population.

This also led to the enactment of new rules in 2019, called the Drugs and Clinical Trials
Rules, 2019.
 OUTPUT AND IMPACT OF THE JUDGEMENT

In response to the court’s ruling in the present case, the Government of India reinforced
clinical trial regulations to enhance transparency, accountability, and ethical standards in
medical research. Key changes included:

1. Stricter Clinical Trial Regulations

 The New Drugs and Clinical Trials Rules, 2019, which implemented stricter guidelines for
the approval process, trial monitoring, and participant compensation.
 Expanded responsibilities of Ethics Committees, ensuring stricter oversight of trials,
protection of patient rights, and proper informed consent procedures.
 Enhanced monitoring systems to track adverse drug reactions and identify regulatory
violations more effectively.

2. Enhanced Oversight and Accountability

 The Drug Controller General of India (DCGI) was instructed to strengthen the
enforcement of clinical trial regulations.
 Ethics Committees and Institutional Review Boards (IRBs) were given a more active role
in safeguarding participants' rights.
 Multinational pharmaceutical companies conducting trials in India were subjected to
increased scrutiny.

3. Greater Transparency in Clinical Trials

 The informed consent process was reinforced, ensuring participants were fully aware of
potential risks before joining a trial.
 Clinical trials were required to adhere to international ethical standards, preventing the
exploitation of vulnerable individuals.
 Mandatory registration of clinical trials in public databases was introduced to improve
transparency.

4. Stronger Deterrence Against Unethical Practices

 The judgment served as a significant deterrent against unethical and unlawful clinical
trials in India.
 Stricter penalties for non-compliance were introduced to discourage regulatory violations.
 Pharmaceutical companies adopted a more cautious approach to conducting trials to
mitigate legal and reputational risks.
 ANALYSIS OF THE REGULATORY FRAMEWORK PERTAINING CLINICAL TRIALS IN
INDIA

The interim orders of the Supreme Court in the case of Swasthya Adhikar Manch led to the
Central Drugs Standard Control Organization (CDSCO), the national regulatory body for
pharmaceuticals and medical devices in India, issuing a directive mandating audio-video
recording (AVR) of the informed consent process in all clinical trials. Up to 2020, no
rigorous penalties have been issued for non-adherence to ethical guidelines in research, such
as non-compliance with the legally required informed consent procedures.

The regulation of clinical trials is examined within the broader scope of pharmacovigilance.
Since India's clinical research industry is still developing, the pharmacovigilance mechanisms
are also in their early stages. At this stage, it is essential to understand the regulatory
framework before delving further.

The Drug Controller General of India (DCGI) serves as the licensing and monitoring
authority for clinical trials. Once DCGI approval is obtained, the trial sponsor must submit
the necessary trial-related information. The approval process follows a two-tiered structure,
in addition to obtaining clearance at the central level, the sponsor must also seek approval
from the local ethics committee at the trial site. Only after these approvals are granted can the
clinical trial begin.

The foundation of India's clinical trial regulatory framework is laid out in Schedule Y of the
Drugs and Cosmetics Rules, 1945, which was amended in 2005. This framework is further
supplemented by the Ethical Guidelines for Biomedical Research, issued by the Indian
Council of Medical Research (ICMR), and the Good Clinical Practice (GCP) guidelines,
established by the Central Drugs Standard Control Organization (CDSCO).

The Good Clinical Practice (GCP) guidelines were introduced by the Central Drugs Standard
Control Organization (CDSCO) in 2001. Following an amendment to Schedule Y in January
2005, the GCP guidelines gained legal status.
The core principle of GCP is that the sanctity of human life must never be compromised,
even in the name of scientific and societal advancement. The guidelines emphasize two key
principles: safeguarding the rights of human participants and ensuring the integrity of
biomedical data. Overall, the GCP guidelines largely reaffirm the ICMR guidelines and
acknowledge international ethical frameworks like the Declaration of Helsinki, which served
as their foundational reference.

The Ethical Guidelines for Biomedical Research on Human Participants (referred to as

the Guidelines) were issued by the Indian Council of Medical Research (ICMR) with a
purpose similar to the CIOMS guidelines. ICMR aimed to adapt universal ethical principles
to better suit the Indian context. The Guidelines, first introduced in 2006, outline ethical
standards for biomedical research involving human participants.

The introductory chapter details twelve fundamental principles of biomedical ethics, with the
principle of essentiality at its core. This principle states that human participants should only
be involved in research if all other possible alternatives have been thoroughly explored,
existing research has been carefully reviewed, and it is determined that human involvement is
absolutely necessary for the study.

While the Ethical Guidelines align closely with the CIOMS Guidelines regarding research on
vulnerable groups, they include an additional significant provision. The Guidelines recognize
individuals with reduced autonomy, such as those whose freedom is legally restricted (e.g.,
prisoners) or informally limited by relationships like employer-employee dynamics.

The Guidelines also state that adequate justification must be provided when recruiting such
individuals to counter any assumption of undue influence or coercion. Additionally,
compensation provisions apply not only for participation in research but also in cases of
accidental injury during the study.

Previously, clinical trials were conducted following the guidelines outlined in Schedule Y of
the Drugs and Cosmetics Rules, 1945 (D&C Rules). However, concerns arose regarding
patient safety and the adequacy of compensation for participants who experienced adverse
effects as a result of their involvement in clinical trials.
Regulatory shortcomings in clinical trials were highlighted in the 59th Report of the
Parliamentary Standing Committee on Health and Family Welfare regarding the functioning
of the Central Drugs Standard Control Organisation (CDSCO), as well as in a report by an
expert committee led by Prof. Ranjit Roy Chaudhury, established by the Ministry of Health
and Family Welfare (MoHFW).

Subsequently, on February 1st, 2018, the MoHFW released a draft of the New Drugs and
Clinical Trials (NDCT) Rules for public feedback, allowing stakeholders to submit their
comments. However, the finalization process took longer than expected. The Supreme Court,
noting the delay, addressed the issue in an order dated December 4, 2018. The Government
assured the Court that the rules would be finalized within two months, with the possibility of
an earlier completion if feasible. Ultimately, the NDCT Rules were officially notified on
March 19, 2019.

The New Drugs and Clinical Trials (NDCT) Rules have replaced Part XA and Schedule Y of
the Drugs and Cosmetics Rules (D&C Rules). The previous regulatory framework consisted
of various temporary measures, leading to inconsistencies. The introduction of a dedicated
and comprehensive set of rules for regulating new drugs and clinical trials is expected to
bring greater clarity and coherence towards fostering India's clinical trial regulations.
 OTHER JUDICIAL PRONOUNCEMENTS OPINED OVER THE YEARS

Some other recent cases related to clinical trials are can be observed as follows:

1) Jacob Puliyel vs. Union of India (2022)

This case the petition was a pediatrician and also was a member of national technical
advisory group immunization. In this case he expressed concerns regarding the approval of
the vaccines of COVID 19 contending lapses in approval. He asked for the publication of
segregated clinical trial data for these vaccines and also questioned the non-disclosure of the
trial outcomes. The supreme court accepted and acknowledged all these concerned and asked
for maintaining transparency in the process of approval of clinical trials for the purpose of
holding public trust in the vaccination process.

2) Sanjeev Kumar v. Union of India & Ors (2021)

This was a PIL in which petitioner called Sanjeev Kumar had challenged the process of
approval that was granted by drugs controller general of India for the phase 2 and 3 of the
Covaxine clinical trial on the children aged from 2 to 18 years. In this petition concerns were
raised about ethical consequences and also the risk associated with the conduct of the clinical
trial on the minors. This led the Delhi High court to issue notices to the Government of India
and also to Bharat biotech but the court rejected the suggestion of imposing any interim stay
on the clinical trials.

3) PIL against Patanjali Ayurved's "coronil" (2020)

In the year 2020 Patanjali Ayurved which is a prominent company in India, specialising in
various ayurvedic products announced launch of its Covid vaccine, "coronil". This led to
several backlash and questions regarding the scientific process or evidence followed if there
is any, supporting the efficacy of this vaccine and other safety concerns were raised. Many
PILs were file which alleged that the company screens where unverified and misleading and
there was no process of clinical trial that took place. The ministry of Ayush asked the
company not to advertise the product and sell it as a cure of Covid till the time it does not
substantiate its claims. The Madras High court also imposed a stringent fine on the company
for making such unsubstantiated claims without having proper scientific evidence and
process being followed.
 CONCLUSION AND THE WAY FORWARD

Globalization has greatly influenced science and technology, even the science of clinical
trials. The latter are not confined to borders anymore and are now being outsourced to other
nations. With such transnational extension, new worldwide players have appeared, especially
multinational drug companies, who are responsible for both outsourcing and running clinical
trials across the globe. The purpose of globalization in the clinical trial market is motivated
by the utilitarian principle of enhancing the global healthcare systems across the globe. The
persons who are regulating these trials tend to adopt a well-known but argumentative
argument, and that is that the death of some is desirable for the majority of human beings.
They also highlight forced participation under the banner of beneficence, presenting it as a
requirement for the improvement of medical advancement.

The case was instrumental in transforming India's clinical trial regulations to better protect
human rights and hold drug companies accountable. Clinical trials are not performed for the
purpose of "entertainment," yet the main contention of this paper is that the root defect of the
present approach is that it uses people as disposables—either for pleasure or the greater good.
The new legislation should tackle this by placing emphasis on the safeguarding of
participants from systemic human rights violations. It should take a framework that respects
participants' rights, not as collateral casualties in the quest for medical progress, but as human
beings worthy of dignity.