Drug Regulation Agencies and Functions in India
Meaning
Introduction
Key
function
Agencies
in
INDIA
Agencies
in
US
Agencies
in
JAPAN
Agencies
in
EU
ICH
References
D
r
u
g
“
All
medicines
for
internal
or
external
use
of
human
beings
or
animals
and
all
substances
intended
to
be
used
for
diagnosis,
treatment,
mitigation
or
prevention
of
any
disease
or
disorder
in
human
beings
or
animals
.”
R
e
g
u
l
a
t
i
o
n
“To
regulate
means
to
control
something
so
that
it
functions
properly
”.
Drugs
play
important
role
in
the
health
and
economy
of
a
country.
Pharmaceutical
drugs
are
available
from
number
of
source.
To
ensure
that that
they
meet
prescribed
standards
.
To
ensure
the
safety,
efficacy
and
quality
of
drugs
as
well
as
accuracy
and
appropriateness
of
the
drug
information
available
to
the
public
.
Product
registration.
Regulation
of
drug
manufacturing,
importation
,
and
distribution.
Adverse
drug
reaction
monitoring.
Licensing
of
premises
&
persons
&
practices.
Main
goal
of the
agency
is
to
guarantee
the
safety
,
efficacy,
and
quality
of
the
available drug product
.
DRUG
RE
G
UL
A
TION
QUALITY
CO
N
TROL
D
R
UGS
LAWS
.
DRUG
RE
G
UL
A
T
O
R
Y
BOARDS
DRUG
REGUL
A
T
O
R
Y
AGENCY
DRUG
I
N
F
O
RM
A
TION
CENTER
Central
Drug
Standard
Control
Organization
(CDSCO)
Ministry
Of
Health
&
Family
Welfare
(MHFW)
Indian
Council
Of
Medical
Research
(ICMR)
Indian Pharmaceutical
Association
(IPA)
Drug
Technical
Advisory
Board
(DTAB)
Central
Drug
Testing
Laboratory
(CDTL)
Indian
Pharmacopoeia
Commission
(IPC)
National
Pharmaceutical
Pricing
Authority
(NPPA)
To
approve
license to
the
various
manufacturing
of
certain
categories
of
drug
as
central
licensing
approving
authorities
i.e.
For Blood
Banks,
Large
Volume
Parental
And
Vaccines
And
Sera.
To
regulate the
standards
of
the
imported
drug
products.
Work
Relati
n
g
To
The
Drug
Tec
h
n
ical
A
d
visory Board
(DTAB)
And
Drugs
Consultative
Committee.
Testing
Of
Drugs
By
Central Drugs
Lab.
Publication
Of
The
Indian
Pharmacopeia.
MAIN
BODIES
The
Food
And
Drug
Administration
(FDA).
National
Institute
Of
Health
(NIH).
Centers
For
Disease
Control
And
Prevention
.
Department
Of
Health
And
Human
Service
(DHHS).
Fed
World
Us
Information
.
National
Center
For
Complementary
And
Alternative
Medicine
(NCCAM).
The Food and Drug Modernization Act
states
that the FDA
has
4
roles:
To
promote
health
by
reviewing
research
and
approving
new
products.
To
ensure
foods
and
drugs
are
safe
and
properly
labeled.
To
work
with
other
nations
to
“reduce
the
burden
of
regulation”.
To
cooperate
with
scientific
experts
and
consumers
to
effectively
carry
out
these
obligations.
FDA
The
Office
of
the
Co
mm
issioner
(OC)
The Center for
Drug
Evaluation
and
Research
(CDER)
The Center for
Biologics
Evaluation
and
Research
(CBER)
The Center for
Food Safety
and
Applied
Nutrition
(CFSAN)
The
Center
for
Devices and
Radiological
Health
(CDRH)
The
Center
for
Veterinary
Medicine
(CVM)
The National
Center for
Toxological
Research
(NCTR)
The
Office
of
Regulatory
Affairs
(ORA)
Center
for
tobacco
product
Protecting
the
public
health
by
Assuring
that
the
food
products
are
safe.
Assuring
human
and
veterinary
drugs,
and
vaccines
and
other
biological
products
and
medical
devices
intended
for
human
use
are
safe
and
effective.
Protecting
the
public from
electronic
product
radiation.
Assuring
cosmetics
and
dietary
supplements
are
safe
and
properly
labeled.
Advancing
the
public
health
by
helping
to speed
product
innovations.
Helping
the
public
get
the
accurate
science-based
information
they
need
to
use
medicines,
devices,
and
foods
to
improve
their
health.
MAIN
BODIES:
Ministry
of
Health
and
Welfare
National
Institute
of
Infectious
Diseases
National
Institute
of
Health
Sciences
In
January
1938,
the
Ministry
of
Health
and
Welfare
was
established
by
integrating
the
administrations
of
the
Sanitary
Bureau
and
the
Social
Affairs
Bureau
in
the
Ministry
of
Home
Affairs.
In
September
1947
The
Ministry
of
Labour
was
established
by
integrating
labour
administrations
that
had
previously
been
conducted
by
the
Ministry
of
Health
and
Welfare.
17
M
H
LW
Minister’s
secretariat
Heath
policy
bureau
Heath
service
bureau
Social insurance
a
a
g
ge
en
n
c
c
y
y
Ministry
proper
PFSB
Social
welfare &
war
victim’s
relief
bureau
H
H
e
e
a
a
l
l
t
th
h
a
a
n
nd
d
w
w
e
e
l
l
f
f
a
a
r
r
e
e
b
b
u
ur
re
e
a
a
u
u
f
f
o
o
r
r
e
el
l
d
de
e
r
r
l
l
y
y
Equal
employment
children
&
family
bureau
Insurance
bureau
Pension
bureau
Director
general
for policy
planning
Social
Welfare
:
Services
for
elderly
people
Services
for persons
with
disabilities
Social Security
:
Pension
systems
that
will
ensure
income
in
elderly
age
Long
term insurance
to
provide
nursing
care
services
Public
assistance
systems
that guarantee
minimum
standards.
Public
Hygiene
:
Appropriate
medical
services
for
diseases
&
injuries
Ensuring
the
safety
of
food,
Water
and
medical
supplies
Research
into
health
science
in
order
to
make
technological
advances
Maternal
and
child
health
Job Security
:
Promotion
of
employment
Employment
of
elderly
people
Employment
of
persons
with
disabilities
Management
of
the
employment
insurance
system
MAIN
BODIES:
EU
Legislation
-
Eudralex
European
Directorate for
the
Quality
of
Medicines
and
Healthcare
(EDQM)
European
Medicines
Agency
(EMEA)
Heads
of
Medicines
Agencies
(HMA)
The
EDQM
(Council
of
Europe)
is
a
key
European
Organisation
involved
in
Harmonisation
&
Co-ordination
of
Standardisation,
Regulation
&
Quality
Control
of
Medicines,
Blood
Transfusion,
Organ
Transplantation,
Pharmaceuticals
and
Pharmaceutical
Care.
In
1996
The
European
Directorate
for
the
Quality
of
Medicines
(EDQM)
is
created.
To
contribute
to
the
basic
human
right
of
access
to
good
quality
medicines
and
healthcare
and
to
promote
and
protect
human
and
animal health
by:
Establishing
and
providing
official
standards
which
apply
to
the
manufacture
and
quality
control
of
medicines
in
all
signatory
States of
the
"Convention
on
the
Elaboration
of
a
European
Pharmacopoeia"
and
beyond;
Ensuring
the
application
of
these
official
standards
to
substances used
in
the production
of
medicines.
EMA
is
a
European
agency
for
the
evaluation
of
medicinal
pr
o
d
u
ct.
EMA
was
set
up
in
1995.
From
1995
to
2004,
EMA
was
known
as
European
agency
for
the
evaluation
of
medicinal
product.
The
European
Medicines
Agency
(EMA)
is
a
decentralized
body
of
the
European
Union,
located
in
London
Mission
:
to
foster
scientific
excellence
in
evaluation
and
supervision
of
medicines
Provides
independent,
science-based
recommendations
on
the
quality,
safety
and
efficacy
of
medicines.
Applies
efficient
and
transparent
evaluation
procedures
to
help
bring new
medicines
to
the
market.
Implements
measures
for continuously supervising
the
quality,
safety
and
efficacy
of
authorised
medicines.
Provides
scientific
advice
to
stimulate
the
development
and
improve
the
availability
of
innovative
new
medicines
Drug regulation in India involves various agencies like CDSCO, ICMR, and NPPA to ensure the safety, efficacy, and quality of pharmaceutical drugs. Activities include product registration, quality control, and monitoring adverse drug reactions to protect public health.
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Presentation Transcript
Meaning Introduction Keyfunction Agencies in INDIA Agencies in US Agencies in JAPAN Agencies in EU ICH References
Drug All medicines for internal or external use of human beings or animals and all substances intended to be used for diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals. Regulation To regulate means to control something so that it functions properly .
Drugs play important role in the health and economy ofa country. Pharmaceutical drugs are available from number of source. To ensure that that they meet prescribed standards. To ensure the safety, efficacy and quality of drugs as well as accuracy and appropriateness of the drug information available to the public.
Product registration. Regulation of drug manufacturing, importation , and distribution. Adverse drug reaction monitoring. Licensing of premises & persons &practices. Main goal of the agency is to guarantee the safety , efficacy, and quality of the available drug product .
QUALITY CONTROL DRUG DRUGS LAWS . INFORMATION CENTER DRUG REGULATION DRUG DRUG REGULATORY BOARDS REGULATORY AGENCY
Central Drug Standard Control Organization (CDSCO) Ministry Of Health & Family Welfare (MHFW) Indian Council Of Medical Research(ICMR) Indian Pharmaceutical Association(IPA) Drug Technical Advisory Board(DTAB) Central Drug Testing Laboratory(CDTL) Indian Pharmacopoeia Commission(IPC) National Pharmaceutical Pricing Authority(NPPA)
To approve license to the various manufacturing of certain categories of drug as central licensing approving authorities i.e. For Blood Banks, Large Volume Parental And Vaccines And Sera. To regulate the standards of the imported drug products. Work Relating ToThe Drug TechnicalAdvisory Board (DTAB) And Drugs Consultative Committee. Testing Of Drugs By Central DrugsLab. Publication Of The Indian Pharmacopeia.
MAIN BODIES The Food And Drug Administration (FDA). National Institute Of Health (NIH). Centers For Disease Control And Prevention . Department Of Health And Human Service(DHHS). FedWorld Us Information . National Center For Complementary And Alternative Medicine (NCCAM).
The Food and Drug Modernization Actstates that the FDA has 4roles: To promote health by reviewing research and approving new products. To ensure foods and drugs are safe and properlylabeled. To work with other nations to reduce the burdenof regulation . To cooperate with scientific experts and consumers to effectively carry out theseobligations.
The Office of the Commissioner (OC) The Center for Drug Evaluation and Research (CDER) Centerfor tobacco product The Center for Biologics Evaluationand Research (CBER) The Office of Regulatory Affairs (ORA) FDA The Center for Food Safety and Applied Nutrition (CFSAN) The National Center for Toxological Research(NCTR) The Center for Veterinary Medicine (CVM) The Centerfor Devices and Radiological Health (CDRH)
Protecting the public health by Assuring that thefood products are safe. Assuring human and veterinary drugs, andvaccines and other biological products and medical devices intendedfor human use are safe andeffective. Protecting the public from electronic productradiation. Assuring cosmetics and dietary supplements are safeand properly labeled. Advancing the public health by helping to speedproduct innovations. Helping the public get the accurate science-based information they need to use medicines, devices, andfoods to improve their health.
MAIN BODIES: Ministry of Health and Welfare National Institute of Infectious Diseases National Institute of Health Sciences
In January 1938, the Ministry of Health and Welfare was established by integrating the administrations of the Sanitary Bureau and the Social Affairs Bureau in the Ministry of Home Affairs. In September 1947 The Ministry of Labour was established by integrating labour administrations that had previously been conducted by the Ministry of Health and Welfare.
Social insurance aagg ee nnccyy MHLW Ministry proper HHeeaalltt hh aann dd wweellffaarree bbuu rr eeaauu ffoorreellddeerrllyy Minister s secretariat Equal employment children & family bureau Heath policy bureau Heath service bureau Insurance bureau PFSB Pension bureau Social welfare & war victim s relief bureau Director general for policy planning 17
Social Welfare : Services for elderly people Services for persons with disabilities Social Security : Pension systems that will ensure income in elderlyage Long term insurance to provide nursing careservices Public assistance systems that guarantee minimum standards.
Job Security : Public Hygiene : Appropriate medical services for diseases &injuries Ensuring the safety of food, Water and medicalsupplies Research into health science in order to make technological advances Maternal and child health Promotion of employment Employment ofelderly people Employment ofpersons with disabilities Management of the employment insurance system
MAIN BODIES: EU Legislation - Eudralex European Directorate for the Quality of Medicines and Healthcare (EDQM) European Medicines Agency (EMEA) Heads of Medicines Agencies (HMA)
The EDQM (Council of Europe) is a key European Organisation involved in Harmonisation & Co-ordination of Standardisation, Regulation & Quality Control of Medicines, Blood Transfusion, Organ Transplantation, Pharmaceuticals and Pharmaceutical Care. In 1996 The European Directorate for the Qualityof Medicines (EDQM) is created.
To contribute to the basic human right of access to good quality medicines and healthcare and topromote and protect human and animal healthby: Establishing and providing official standards which apply to the manufacture and quality control of medicines in all signatory States of the "Convention on the Elaboration of a European Pharmacopoeia" and beyond; Ensuring the application of these official standards to substances used in the production ofmedicines.
EMA is a European agency for the evaluation ofmedicinal product. EMA was set up in1995. From 1995 to 2004, EMA wasknown as European agency for the evaluation of medicinal product. The European Medicines Agency (EMA) is a decentralized body of the European Union, located in London Mission: to foster scientific excellence in evaluation and supervision of medicines
Provides independent, science-based recommendations on the quality, safety and efficacy ofmedicines. Applies efficient and transparent evaluationprocedures to help bring new medicines to themarket. Implements measures for continuously supervisingthe quality, safety and efficacy of authorisedmedicines. Provides scientific advice to stimulate the development and improve the availability of innovative newmedicines
