The importance of learning about medicines’ and vaccines’ efficacy or effectiveness trials is not only necessary to those who are developing, producing or marketing these pharmaceutical products but to the users also because: The Emergency approval of Covid-19 vaccines and many other medicines in last few years has created so much fuss to understand the reality. The lesson learnt from Covid-19 vaccine(s) by vaccine production, marketing, vaccination and finally the revenue earned by vaccine developers and producers, and political gain by politicians, is proving deleterious to the society as several vaccine(s), useless or scarcely proven safe and useful, are going to infest and some have already infested the market (the health industry). So reading this presentation may be useful to you so that you may question the authorities if any is engaged in bluffing you. The presentation talks briefly about Prevention trials, Screening trials, Treatment trials, Feasibility studies, Pilot studies, Phases in clinical trial, Multi-arm multi-stage (MAMS) trials, Global Clinical Trials, Vaccine efficacy, Vaccine safety, Emergency Use Authorization (EUA), Serious Adverse Events (SAE), SEA rules, The Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), The Advisory Committee on Immunization Practices (ACIP), Clinical Immunization Safety Assessment (CISA), CDSCO Rules Governing Clinical Trials, Schedule Y, The Ethics Committee, Empowered Committee on Animal Health, Tracking Vaccine Quality, Pre-clinical and Clinical data, Proof of Concept, Biological License Application (BLA) and Clinical hold.

1. Types of Medicine/
Vaccine Efficacy/ Effectiveness Trials
and Relevant Rules
DOI: 10.13140/RG.2.2.17419.26402
Available at
https://www.researchgate.net/publication/372966585_Types_of_Medicine_Vaccine_Efficacy_E
ffectiveness_Trials_and_Relevant_Rules
Bhoj R Singh
Division of Epidemiology, ICAR-IVRI,
Izatnagar-243122, India
brs1762@gmail.com
1

2. Introduction
The importance of learning about medicines’ and vaccines’ efficacy or
effectiveness trials is not only necessary to those who are developing,
producing or marketing these pharmaceutical products but to the users
also because: The Emergency approval of Covid-19 vaccines and many
other medicines in last few years has created so much fuss to understand
the reality. The lesson learnt from Covid-19 vaccine(s) by vaccine
production, marketing, vaccination and finally the revenue earned by
vaccine developers and producers, and political gain by politicians, is
proving deleterious to the society as several vaccine(s), useless or
scarcely proven safe and useful, are going to infest and some have
already infested the market (the health industry). So reading this
presentation may be useful to you so that you may question the
authorities if any is engaged in bluffing you. The presentation talks
briefly about Prevention trials, Screening trials, Treatment trials,
Feasibility studies, Pilot studies, Phases in clinical trial, Multi-arm multi-
stage (MAMS) trials, Global Clinical Trials, Vaccine efficacy, Vaccine
safety, Emergency Use Authorization (EUA), Serious Adverse Events
(SAE), SEA rules, The Vaccine Adverse Event Reporting System (VAERS),
Vaccine Safety Datalink (VSD), The Advisory Committee on Immunization
Practices (ACIP), Clinical Immunization Safety Assessment (CISA), CDSCO
Rules Governing Clinical Trials, Schedule Y, The Ethics Committee,
Empowered Committee on Animal Health, Tracking Vaccine Quality, Pre-
clinical and Clinical data, Proof of Concept, Biological License Application
(BLA) and Clinical hold. 2

3. Observational studies and Clinical Trials
A. Observational studies: Monitor a subset of the population in standard settings to
gather information and compare changes over the time, e.g., researchers may ask
or observe feeding schedules or milking schedules and milk production for a year
to learn how feeding and milking schedules are associated with milk production.
Observational studies do not test a medical intervention, such as a drug or device.
Still, they may help identify new treatments or prevention or production-increasing
strategies to be tested in clinical trials.
B. Interventional trials aim to discover more about a particular intervention, or
treatment. May be:
• Experimental studies: Usually done in experimental animals followed by target
animals to determine toxicity, safety, efficacy, and putative route of inoculation/
administration, doses of vaccine/ drug. Experimental stock is divided into a suitable
number of groups and the challenge is usually an integral part of the experiment
• Clinical trials: Conducted only after getting satisfactory or desirable results in
experimental studies. Studies to test a medical, surgical, behavioural or diagnostic
intervention in a population with the primary aim to determine either a new form of
treatment or prevention, such as a new drug, diet, or medical device (for example, a
pacemaker), is safe and effective or not. A clinical trial is designed to learn if a new
treatment is more effective or has less harmful side effects than existing treatments.
• Clinical Trial means a systematic study of any new drug(s) in trial population to
generate data for discovering and/or verifying the clinical, pharmacological
(including pharmacodynamics and pharmacokinetics), and/or adverse effects with
the objective of determining safety and/or efficacy of the new drug.
3

4. Observational Studies
Cohort studies: A cohort is a group of individuals having something in common (age,
sex, food habit, work, or exposure) that is followed over a period of time. A
research team may recruit participants who do not have the disease and collect
information about them for a number of years. The researchers see who in the
group develops the disease and who doesn’t. They then look to see whether those
who developed the disease had anything in common. Cohort studies are very
useful ways of finding out more about risk factors. But they are expensive and
time-consuming. They can be used when it wouldn’t be possible to test a theory
any other way.
Case-control studies: Case-control studies work the opposite way to cohort studies.
The research team have a disease (cases) in a group and another group that don't
have the disease (controls). They then look back to see how many individuals in
each group were exposed to a certain risk factor. To make the results as reliable as
possible each group have the same general factors such as age or gender except
the disease. Case-control studies are quicker and cheaper than cohort studies. But
the results may be less reliable. The research team often rely on the memory of
the people/ owner of livestock thinking back and remembering whether there was
an exposure to a certain risk factor or not. But people may not remember
accurately, and this can affect the results.
Cross-sectional studies: Cross-sectional studies are carried out at one point in time, or
over a short period of time. They find out who has been exposed to a risk factor
and who has developed the disease, and see if there is a link. Cross-sectional
studies are quicker and cheaper to do. But the results can be less useful.
Sometimes researchers do a cross-sectional study first to find a possible link. Then
they go on to do a case-control or cohort study to look at the issue in more detail.
4

5. Types of Trials
• Feasibility studies: To assess if it is possible to do the
main study. They aim to find out things such as
whether patients (animal owners and society) and
doctors are happy to take part, and how long it might
take to collect and analyse the information. They don’t
answer the main research question about how well a
treatment works.
• Pilot studies are small versions of the main study. Pilot
studies help to test that all the main parts of the study
work together. They may also help answer the research
question. Sometimes the research team include the
information collected during the pilot study in the
results of the main study.
5

6. • Prevention trials: They look at whether a particular treatment can
help prevent a disease, mainly for vaccines or for preventable
diseases. Only health subjects or livestock are included. These trials
can be for the general population or for a target population that has
a higher-than-normal risk of developing a certain disease.
• Screening trials: These trials are usually done for the new
diagnostic tests/ tools on a healthy population or target population
for the early signs of the diseases like cancer/ mastitis/ infertility
before they have any symptoms. As with prevention trials,
screening trials can be for the general population or a targeted
population that has a higher than-normal risk of developing the
targeted condition such as mastitis, milk fever etc. It is done to find
if new tests are reliable enough to detect particular types of
disease. Or they may try to find out if there is an overall benefit in
early diagnosis.
• Treatment trials/ clinical trials: Done in phases. The early phases
aim to find out more about the safety and side effects of a new
vaccine/ drug/ treatment. Later phases aim to see if a new vaccine/
drug/ treatment works better than the current treatment. Or if a
new treatment works better than a dummy drug (placebo).
6

7. • Multi-arm multi-stage (MAMS) trials: A multi-arm trial is a
trial that compares several interventions at a time and
has:
– several treatment groups as well as
– the standard treatment group (the control group )
– Multi-arm multi-stage (MAMS) trials have the same control
group all the way through. The other treatment groups can
change as the trial goes on. As these trials are more complex
there are a number of treatments/ vaccines.
– The research team may decide to stop recruiting individuals to a
particular group. This could be because they have enough
individuals to start looking at the results. Or because early
results show the treatment isn’t working as well as they’d
hoped.
– The researchers may add new treatment groups as new drugs
become available to look at. This means they don’t have to
design and launch a brand new trial each time they want to
research a new treatment. So it helps get results quicker.
7

8. Clinical trial norms
• Research staff explain the trial or study in detail, answer your questions, and gather more
information about you and your livestock.
• Once you agree to participate, you sign an informed consent form indicating your understanding
of what to expect as a participant and the various outcomes that could occur.
• Your livestock are screened to make sure that your farm qualifies for the trial or study.
• If accepted into the trial, you schedule a first visit of the research team, which is called the
“baseline” visit. The researchers conduct required and/or physical tests during this visit.
• For some trials testing an intervention, your farm or animals on your farm are assigned by chance
(randomly) to a treatment group or a control group. The treatment group will get the intervention
tested, and the control group will not.
• You follow the trial procedures and report any issues or concerns to researchers immediately.
• Your farm may be visited by the researchers regularly at scheduled times for new symptoms/
signs, physical, or other evaluations and discussions with you. During these visits, the research
team collects data and monitors the safety and well-being and production parameters of your
livestock
• Your farms continue to have regular veterinary visits for usual health care throughout the study.
• Once a clinical trial or study ends, the researchers analyze the data to determine what the findings
mean and to plan the next steps. As a participant, you should be provided information before the
study starts about how long it will last, whether your animals will continue receiving the
treatment after the trial ends (if applicable), and how the results of the research will be shared. If
you have specific questions about what will happen when the trial or study ends, you may ask the
research coordinator or staff. 8

9. Different Phases of Clinical Trials
Clinical trials advance through different phases to test safety, determine effectiveness, and identify any side
effects. The CDSCO in India or the FDA typically requires Phase 1, 2, and 3 trials to be conducted to
determine if the vaccine, drug or device can be approved for further use. If researchers find the
intervention to be safe and effective after the first three phases, the approving body permits it for clinical
use and continues to monitor its effects.
Each phase has a different purpose:
• Phase 1 trial: Tests an experimental drug or device on a small group (around 20 to 80) to judge its safety,
and side effects, and to determine doses. A few months.
• Phase 2 trial: Conducted on larger groups, around 100 to 300 subjects to determine whether a vaccine/
drug is effective for the intended purpose. In this phase, efficacy is determined on different target groups
like milking/ non-milking, males/ females, young/ adults, suffering from target disease/ healthy to
examine the safety, including short-term side effects. Several months to two years.
• Phase 3 trial: Conducted on larger populations usually several hundred to a few thousand or more, and
in different regions and countries to gather additional information about safety and effectiveness,
studying different populations and different dosages, and comparing the intervention with other
vaccines/ drugs or treatment approaches. If the approving body agrees with the trial results useful for
the intended use, it will approve the experimental vaccine/ drug or device. About one to four years.
• Phase 4 trial: It takes place after approval of the vaccine/ drug or device. The treatment’s or vaccine’s
effectiveness and safety are monitored in large, diverse populations over a longer time. Sometimes, the
duration of immunity and the extent of immunity for a vaccine and side effects may not become clear
until the drug/ vaccine or device is used on more subjects over a longer period of time. Several years
maybe decades.
• After each trial ends, researchers must submit study reports. To avoid the clinical hold.
9

10. Clinical hold on trials
Clinical hold to delay or stop the investigation may be
placed by approving authorities like CDSCO/ FDA/
CPCSEA. Clinical holds are rare. Rather authority
provides comments intended to improve the quality of
a clinical trial.
Clinical hold can be put for specific reasons, including:
– Participants are exposed to unreasonable or significant
risk.
– Investigators are not qualified.
– Materials for the volunteer participants are misleading.
– The application does not include enough information
about the trial’s risks.
10

11. Vaccine development stages
Research and Discovery: In this early stage researchers explore their idea for
a potential vaccine. Vaccine development often takes 10-15 years of
laboratory research, and often involves collaboration with researchers at
different institutes/ departments.
Proof of Concept: Before a vaccine can be tested in the target population,
researchers have to prove its ability to induce an immune response in
small animals, like mice. At this stage, researchers may make adjustments
to the vaccine to make it more effective. Vaccine effectiveness is
important because it measures how well vaccination protects against
outcomes such as infection, symptomatic illness, hospitalization, and
death.
If the vaccine shows promising enough results, it moves forward to
clinical trials for testing in people.
Testing the Vaccine: Once the vaccine enters a clinical development stage, it
is called a clinical trial. To do this, researchers submit an Investigational
New Drug (IND) application to approving authorities like CDSCO/ FDA,
which includes data from animal studies, information on manufacturing
technology, and the quality of the vaccine. Vaccine quality is important
because it affects how well it will work to provide long- and short-term
protection against disease.
11

12. Approval of the Vaccine
The Vaccine Manufacturing Process: During Phase 3 clinical trials, the
approving authority looks at the company’s proposed manufacturing
process for the vaccine. It will also inspect the manufacturing facility where
the vaccine will be made to ensure the facility has everything necessary for
reliable and consistent large-scale manufacturing.
• The manufacturer makes batches of the vaccine called “lots”. These lots
undergo a series of tests to ensure the vaccine is consistent from lot to lot.
The authority requires manufacturers to submit data from these tests to
support a successful manufacturing process, even after approval.
• Approving the Vaccine: Before a vaccine can be approved for use, a
company submits a Biological License Application (BLA) to the authority.
The BLA includes:
– pre-clinical and clinical data
– details about the manufacturing process
– information about the manufacturing facility
• While reviewing the BLA, the authority looks at the clinical trial data (1st
to 3rd Phase trial) to see if the results show the vaccine is safe and effective.
The BLA also contains prescribing information, which is information on
vaccine usage, dosage, and administration–all based on scientific data. If
needed, the prescribing information can be updated to be reviewed by the
approving authority. Then approving authority decides whether to approve
the vaccine for use.
12

13. • VIRBPAC: In some cases approving authority provides input on scientific data to
look at the safety, effectiveness, and use of the vaccine. In the case of the FDA, this
feedback is based on recommendations of the Vaccine and Related Biological
Products Advisory Committee (VRBPAC), it is made up of independent scientific
and public health experts who discuss the proposed vaccine in a public forum. In
India, Empowered Committee on Animal Health constituted by CDSCO examines
the data of vaccine trials and then suggests either for approval or improvement of
Veterinary Biological products.
• Large-Scale Manufacturing: After approval of the new vaccine, the company can
make larger batches of vaccine to distribute to the public. FDA will continue to
monitor vaccine production activities, which includes regular inspections of the
manufacturing facility to make sure that regulations are being followed. This
continues as long as the manufacturer holds a license for the vaccine product.
• Tracking Vaccine Quality: The authority monitors a vaccine product’s quality in real
time by requiring manufacturers to submit samples of each vaccine lot for testing.
These tests usually report:
– safety
– purity (it only contains the necessary ingredients)
– potency (the vaccine produces the desired immune response)
– CDSCO regularly update about vaccines of Not of Standard Quality (NSQ) at its website:
https://cdsco.gov.in/opencms/opencms/en/biologicals/Vaccines/
• When vaccines are consistent across lots, the authority can confirm the product
remains reliable and safe for use in public.
13

14. Central Drugs Standard Control
Organization
(CDSCO)
Source: https://cdsco.gov.in/opencms/export/system/modules/CDSCO.WEB/resources/pdf/function_new.pdf 14

15. Institutional Ethics Committees
Empowered for approval of clinical trials and experimental studies at the
Institution level. All ethics committees are to be registered with CDSCO. It
is comprised of medical/veterinary, scientific, non-medical/ non-veterinary
and non-scientific members, whose responsibility is to ensure the
protection of the rights, safety and well-being of subjects involved in
clinical trials and it shall be responsible for reviewing and approving the
protocol, the suitability of the investigators, facilities, methods and
adequacy of information to be used for obtaining and documenting
informed consent of the study subjects and adequacy of confidentiality
safeguards. In the case of any serious adverse event occurring to the
clinical trial subjects during the clinical trial, the Ethics Committee shall
analyze and forward its opinion as per the procedure specified under
APPENDIX XII of Schedule Y.
• The Ethics Committee shall allow inspectors or officials authorized by the
Central Drugs Standard Control Organization to enter its premises to
inspect any record, data or any document related to clinical trials and
provide adequate replies to any query raised by such inspectors or
officials, as the case may be in relation to the conduct of clinical trial.
• If the Ethics Committee fails to comply with any of the conditions of
registration, the Licensing Authority may, after giving an opportunity to
show cause why such an order should not be passed, by an order in
writing stating the reasons therefore, suspend or cancel the registration of
the Ethics Committee for such period as considered necessary. 15

16. Approval for marketing &
Emergency Use Authorization
• Before filing a marketing application, a developer must have
adequate data from two large, controlled randomized clinical trials
conducted systematically in the target population/ region.
• Emergency Use Authorization (EUA): Under section 564 of the
Federal Food, Drug, and Cosmetic Act for Emergency Use
Authorization (EUA) of an investigational vaccine the Secretary of
Health and Human Services must make a declaration of emergency
or threat justifying authorisation of emergency use before the FDA
can issue a EUA for any specific product. FDA may authorize
unapproved medical products or unapproved uses of approved
medical products to be used in an emergency to diagnose, treat, or
prevent serious or life-threatening diseases or conditions caused by
chemical, biological, radiological, and nuclear (CBRN) threat agents
when certain criteria are met, including there are no adequate,
approved, and available alternatives.
16

17. Global Clinical Trial in India
& Clinical Trial Rules
• Any clinical trial which is conducted as part of multi-national clinical development
of a drug is named as Global Clinical Trial.
• No clinical trial for a new drug, whether for clinical investigation or any clinical
experiment by any institution, shall be conducted except under, and in accordance
with, the permission, in writing, of the Licensing Authority defined in clause (b) of
Rule 21.
• RULES GOVERNING CLINICAL TRIALS
• The specific Rules are-
• Rule 122 DA – Mandatory requirement of permission from DCG (I) for conduct of
clinical trial of a new drug;
• Rule 122 DAB – Provision for examination of serious adverse event (SAE) of injury
and death and payment of compensation in clinical trial related cases. Provision
for debarment of the applicant in case of failure to pay compensation;
• Rule 122DAC - Conditions of permission for conducting a clinical trial which
includes mandatory requirements to follow Good Clinical Practice (GCP)
guidelines, guidelines and requirements specified in Schedule Y of Drugs and
Cosmetics Rules and other applicable regulations. Provision for debarment of
applicant and investigator in case of non- compliance.
• Rule122 DD – Requirements and guidelines for registration of Ethics Committee;
• Rule122 E – Definition of a new drug;
• Schedule Y - Detailed guidelines and requirements for conduct of clinical trial and
approval of a new drug
17

18. Functionalities of Global Clinical Trials
Division of CDSCO, India
• Processing of applications received for the conduct of Global Clinical Trials (i.e. Form 44),
review, approval and follow-up until the end of the study as per Schedule Y, Rule 122 DA, 122
DAB, 122 DAC and 122 E under Drugs & Cosmetics Rules 1945)
• Review and approval of Test License applications (Form 12) to import Investigational Medicinal
Products (IMP) for Global Clinical Trials.
• Review of notification for Non-interventional/Observational/Academic/Investigator Initiated
Trials.
• Review and approval of post-approval changes in applications like Major protocol amendments
& changes in sponsors/ applicants etc.
• Review of notifications like Minor protocol amendments, Investigator’s Brochure (IB), Informed
Consent Form (ICD), Investigational Medicinal Product Dossier (IMPD), Development Safety
Update Reports (DSUR), site additions/deletions, Changes in Principal investigators/Co-
investigators, Clinical Trial Agreements, Ethics committee approval of PI sites, Annual Status
Reports, End of clinical trial notifications& Clinical Study Reports (CSR) etc.
• Handling complaints, parliament questions and RTI queries related to Global clinical trials.
• Handling/Monitoring of GCP Inspections based on the trial monitoring documents like PSURs,
ASRs, complaints received etc.
• Review & action taken with respect to GCP inspection reports received from Inspection Team/
Zonal Offices (Show-cause notice, response of show-cause notice, warning, debarment,
suspension etc.)
• Database management (receipts/files/other misc. data including permissions generated,
maintenance of guard files of query/approvals, parliament questions answered, CSR etc.)
18

19. Recommending the Vaccine for Use
Recommending the Vaccine for Use: The Advisory Committee on
Immunization Practices (ACIP) is a group of medical and public health
experts who develop recommendations for the use of a vaccine in the
United States.
ACIP only makes recommendations for vaccines that are approved by FDA.
Before recommending any vaccine, ACIP also considers:
– How safe and effective the vaccine is when given at specific ages? A person’s
immune response can vary depending on their age when they receive the
vaccine. Vaccine manufacturers must conduct rigorous studies to show that a
vaccine is safe and effective at specific ages.
– How serious the vaccine-preventable disease is? Without a vaccine, the
disease can be serious enough to potentially cause long-term health problems
or death in children and adults.
– How many would get the disease if there was no vaccine? One of ACIP’s tasks
is to determine if a vaccine has a public health benefits. If a vaccine does not
provide benefit to many people, they may not recommend it for everyone.
• After ACIP recommends a vaccine, the CDC Director will decide whether
to approve the recommendation. Once the CDC Director approves the
recommendation, it becomes the official CDC public health guidance for
the safe use of the vaccine in the United States. The approved
recommendation can also lead to a vaccine becoming a part of the official
U.S. adult and childhood immunization schedules.
19

20. After recommendation of Use of Vaccine
• Even after vaccines are approved and recommended for public use,
CDC and FDA use different independent and interdependent
systems to monitor their Safety, which helps ensure a vaccine’s
continued success.
• The Vaccine Adverse Event Reporting System (VAERS): It is an early
warning system that helps CDC and FDA monitor problems
following vaccination. Anyone can report suspected vaccine
reactions and issues to VAERS.
• Vaccine Safety Datalink (VSD): It is a collaboration between CDC
and several health organizations that allows ongoing monitoring
and proactive searches of vaccine-related data.
• When The Advisory Committee on Immunization Practices (ACIP)
recommends new vaccines for use in the United States or makes
changes to a vaccine’s recommendation, VSD will monitor the
safety of these vaccines.
• CDC’s Clinical Immunization Safety Assessment (CISA) Project: It is
a partnership between CDC and several medical centers that
conduct clinical research on vaccine-related health risks in certain
groups of people.
20

21. Serious Adverse Events after
vaccine/ drug trials in India
Serious Adverse Event (SAE): SAE is an Adverse Event or Adverse Drug Reaction that is associated with
death, in-patient, hospitalisation (in case the study was being conducted on out-patients),
prolongation of hospitalisation (in case the study was being conducted on in-patients), persistent or
significant disability or incapacity, a congenital anomaly or birth defect, or is otherwise life-
threatening.
• Procedures for analysis of SAEs including death occurring during clinical trial to arrive at the cause of
death/ injury to the subject, as the case may be, and to determine the quantum of compensation, if
any as per Rule 122DAB(7), the Sponsor or his representative, whosoever had obtained permission
from the CDSCO for the clinical trial, shall provide financial compensation, if the injury or death has
occurred because of any of the following reasons, namely-
• Violation of the approved protocol, scientific misconduct or negligence by the Sponsor or his
representative or the investigator;
• Failure of investigational product to provide intended therapeutic effect (where, the standard care,
though available, was not provided to the subject as per the clinical trial protocol),
• Use of placebo in a placebo-controlled trial(where, the standard care, though available, was not
provided to the subject as per the clinical trial protocol),
• Adverse effects due to concomitant medication excluding standard care, necessitated as part of the
approved protocol.
• For injury to a child in–utero because of the participation of parents in the clinical trial.
• As per Schedule Y to Drugs & Cosmetics Rules, the Investigator, Sponsor and the Ethics Committee are
required to report all serious adverse events of deaths as well as injury to the Licensing Authority in
time bound manner.
RULES GOVERNING SAEs:
• The Drugs & Cosmetics Rules have been amended vide GSR no 53 (E) dated 30-01-2013 inserting a
Rule 122DAB, and a new Appendix-XII in Schedule-Y along with other amendments. Provision for
debarment of the applicant in case of failure to pay compensation.
Source: https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/SAE/
21

22. • Haste leads to Waste, either it is approval or
development of any medicine or vaccine or anything
else, it is always and repeatedly proven a true rule.
• Covid-19 Vaccine Emergency Use Authorization (EUA)
has paved the way to haste in vaccine development,
approval and vaccination and leading to waste of
human-lives.
• The lesson learnt from Covid-19 vaccine(s) by vaccine
production, marketing, vaccination and finally the
revenue earned by vaccine developers and producers,
and political gain by politicians, is proving deleterious
to the society as several vaccine(s), useless or scarcely
proven safe and useful, are going to infest and some
have already infested the market (the health
industry).
22

23. Quiz
1. Name a few vaccines in Indian market which have not
gone through proper testing (clinical trails) and
approval step before reaching the market.
2. Name a few cases in India when compensation has
been made to participants of clinical trials.
3. Name any three veterinary vaccines in India released
after CDSCO approval in the last 10 years where phase
1-3 trials were conducted systematically.
4. Write a paragraph, “Why the Indian pharmaceutical
market is infested with fake or NSQ medicines,
vaccines, and medical accessories.
5. Name vaccine and medicines notified NSQ by CDSCO,
India.
23