Overview of Central and State Drug Regulatory Bodies in India
Central
and
State
Drug
Regulatory
Bodies
Drug
Regulatory
Authority
•
The drug
regulatory
authority
(DRA)
is the agency that
develops
and
implements
most
of
the
legislation
and
regulations on
pharmaceuticals.
•
Its main
task
is
to ensure
the
quality,
safety
and
efficacy
of
drugs, and
the
accuracy of
product
information.
•
This is done
by
making
certain rules that
the
manufacture,
procurement,
import,
export,
distribution,
supply
and
sale of drugs,
product promotion
and
advertising, and
clinical
trials
are
carried out
according
to
specified
standards.
Functions of
regulatory
authority:
Product
registration
(drug
evaluation
and
authorization,
and
monitoring
of
drug
efficacy
and
safety);
R
egul
a
tion
o
f
dru
g
m
anu
f
a
ctu
r
i
n
g
,
importation,
and
distribution;
Regulation
&
Control
of
drug
promotion
and
information.
Adverse
drug reaction
(ADR)
monitoring.
Licensing of premises,
persons
and
practices.
Main
goal of drug
regulation
is
to guarantee
the
safety,
efficacy and
quality of
drugs
available
to
public.
It
is
governed
by both
Centre
and
State
Governments
under the
Drugs
&
Cosmetics
Act,
1940
.
MAIN
BODIES:
Ministry
Of Health &
Family
Welfare
(MHFW)
Control
Ce
n
t
r
al
Dr
u
g
S
t
anda
r
d
Organization(CDSCO)
Indian
Pharmacopoeia Commission
(IPC)
N
a
tional
Pharma
c
eut
i
c
al
P
r
icing
Au
t
hori
t
y
(NPPA)
•
Th
e
Mini
s
t
ry
(
M
HFW)
of
Hea
l
th
is
a
n
d
F
ami
l
y
W
e
l
f
a
r
e
an
I
ndi
a
n
government
ministry
charged
with
health
policy
in
India. It
is
also
responsible
for
all
government
programs
relating
to
family
planning
in
India.
•
The
ministry
is
composed
of
four
departments:
Health
&
Family
Welfare;
Health
Research;
AIDS
Control;
and
Ayurveda,
Yoga
and
Naturopathy,
Unani,
Siddha
and
Homoeopathy
(AYUSH).
•
Current
cabinet minister is
Shri.
Jagat Prakash
Nadda.
CDSCO
(Central
Drug
Standard Control
Organization)
•
National
regulatory
body
for
Indian
Pharmaceuticals and
medical
devices.
•
Within
CDSCO,
DCGI
(Drug
Controller General
of
India)
regulates
pharmaceutical and
medical
devices
under
gamut
of Ministry of Health
and
Family
Welfare
(
MHFW).
Locations(CDSCO)
:
CDSCO
(Vision)
To
protect
and
promote
public health
CDSCO
(Mission)
•
To
safeguard
and enhance the public health
by
assuring
the
safety,
efficacy
&
quality of
the
drugs, cosmetics, medical
devices.
FUNCTIONS
:
Regulatory
control
over
import,
manufacturing,
sale
&
distribution of
drugs.
Approval
of certain drugs
&
clinical
trials
Meetings
of DCC,
DTAB
A
p
p
r
o
v
al
f
o
r
lice
ns
es
a
s
C
e
n
t
r
al
Li
c
e
ns
e
Approving
Authority
Co-ordination
of
activities
of
State
Drug
Control
Organization
Central
Drug
Laboratory,
Kolkata
(CDL)
•
Statutory
Lab. Of
Gov.
Of India
over
control
of
Drug
&
cosmetics
act,
1940
•
Oldest
QC lab.
Statutory
Functions:
•
analytical QC of majority of imported
drugs
available
in
Indian
market.
•
QC
of
dr
u
gs
&
c
o
s
m
e
tics
m
an
u
f
a
c
tu
r
ed
in
India.
•
Acting
as
appe
l
l
at
e
autho
r
ity
i
n
m
a
t
t
e
r
s
relating to
quality
of
drugs.
Other
functions:
•
Collection,
storage,
distribution of International
Standards,
Int.
reference
preparation
of drugs
and
p’ceutical
substances.
•
Training
to
drug
analyst.
•
Training
to
WHO
fellows
from abroad
on modern
methods of drug
analysis.
Other
laboratories:
•
CDTL,
Mumbai
•
CDTL,
Tamil
nadu
•
CDTL,
Hydrabad
•
RDTL,
Guhawati
•
RDTL,
Chandigarh
•
CDL,
Kasauli
Indian
Pharmacopoeial
Commission(IPC)
•
Autonomous
institute under
MHFW,
Gov.
of
India
•
Dedicated
to
settings of
std.
of drugs,
p’ceuticals
and
healthcare devices
besides
providing
Ref.
Standards
and
Training.
•
To
develop
comprehensive
monographs
for
drugs
included
in IP including
API,
Excipients
and
dosage
forms.
•
To
accord
priority
to
monographs of drugs
in the
National
Essential
Drug
List
& their
dosage
forms.
•
To
accelerate process
of
preparation,
certification, distribution of
IP
reference
sub.
DCGI
(Drug
Controller General
of
India)
•
Drug
Controller General
of
India under
the
gamut
of
Central
Drugs
Standard
Control
Organization
is
responsible
for
approval
of
licenses of
specified
categories
of
drugs such
as
blood
and
blood
products,
IV
fluids,
vaccines
and
sera
in
India.
•
Present DCGI
is
Dr.
G. N.
Singh
Responsibilities
of
DCGI:
•
DCGI
lay
down
the
standard
and
quality
of
manufacturing, selling,
import and
distribution
of
drugs
in
India.
•
Acting
as
appellate
authority in
case of
any
dispute
regarding
the
quality of
drugs.
•
Preparation
and
maintenance of national
reference
standard.
•
To
bring about
the
uniformity
in the
enforcement
of
the Drugs and
Cosmetics
Act.
•
Training
of
Drug
Analysts deputed
by
State
Drug
Control Laboratories
and
other
Institutions.
•
Analysis of Cosmetics
received
as
survey
samples
from
CDSCO
(central
drug
standard control
organization).
DCGI
is advised
by:
Advisory
Board)
S
t
a
t
e
&
G
o
v
.
on
•
T
o
adv
i
ce
Central
technical
arising
m
a
tt
e
r
s
ou
t
of
administration
of
act.
p
r
o
v
i
s
i
o
n
of
•
Under
Se
c
.(
5
)
D
T
AB
(Dru
g
T
echni
c
al
•
DCC(Drug
Consul
t
a
ti
v
e
Committee)
•
Advisory
committee
b
y
Ce
n
t
r
al
G
o
v
.
to
adv
i
ce
S
t
a
t
e
G
o
v
.
&
DTAB
•
U
n
de
r
p
r
o
v
i
s
i
o
n
of
Sec.(3)
Food
&
Drug
Administration
(FDA)
i
n
s
tr
u
me
n
t
of
•
Maha
r
a
s
h
t
r
a
’
s
pr
ima
r
y
consumer.
•
An
law
enforcement
agency.
•
R
esp
o
ns
i
bil
i
ty
of
e
n
f
o
r
cem
e
n
t
of
t
he
prevention
of
Food Adulteration
Act,
1954
•
Th
e
r
e
g
u
l
a
tions
a
r
e
i
m
pleme
n
t
ed
by
following independent
sections:
Drug
section
Food
section
Food
&
drug
control
laboratories
Food
&
Drug
Administration
(FDA)
•
Drugs
are used
to
elevate
health of
people
&
responsibility
for
implementation
of various
rules
&
regulation
for
getting
safer
drugs
&
cosmetics
with
good
quality
&
purity
to
people of
the
state,
is assigned
to
FDA.
•
For
the
drug section,
following
acts
are
implemented by administration
;
Drugs
&
Cosmetics
Act 1940 & rules
there of
1945
D
r
u
g
&
Magic
R
em
e
die
s
(obj
e
ctionable
advertisements)
Act
1954
Drug
Price
(Control)
Order,
1995
Narcotic
drugs
&
Psychotropic
Substance
Act,1985
Poison
Act
1919
Object
:
•
To
ensure
safety,
purity,
quality
of
drugs.
•
To
prevent
consumers
from
self-medication.
•
To
ensure
availability
of
drugs
at
authorized
prices.
•
To
create
awareness
about
importance of
proper
storage
of
drugs.
•
To
eliminate
irrational
combinations.
•
To
prevent
misuse
of
narcotic
drugs.
•
To
prepare
policy
regarding
drug
matter.
Regulate
:
•
To
grant
and
renew
licenses
for
the
following
Categories
of
Drug
Manufacturing
Units
.
–
Allopathic
Drugs
–
Ayurvedic
Drugs
–
Homeopathic
Drugs
–
Unani ,Siddha
Medicines
–
Blood
,Blood
Products
–
Medical
Devices
•
To
approve
Plan
of manufacturing premises
for
Drugs.
•
To
Grant
Licenses
for
Repacking
of
Drugs
•
To
Grant
and
Renew
Licenses
for
Drug Selling
Units.
•
To
Grant
Licenses
for
Public
Testing
Laboratory.
•
To
issue
various Certificates
for
Tenders,
Exports as
listed
below:
–
WHO
GMP
certificate
–
No Conviction certificate
–
Performance
Certificate
–
Free
Sale
Certificate
–
Schedule M GMP
Certificate
•
T
o
i
s
s
u
e
Quo
t
a
o
f
Na
r
c
otic
s
D
r
u
g
s
u
n
d
er
the
Narcotics
Drugs and
Psychotropic
Substances
Act.
•
To
issue
Transport
Permits
under
NDPS
Act.
•
To
investigate
complaints received
regarding
drugs
•
T
o
c
ar
r
y
ou
t
in
s
p
e
c
tions
o
f
manu
f
a
cturing
and
selling
Units
•
To
draw
samples of
Drugs
•
To
conduct raids
for
those
manufacturing
spurious
drugs
/substandard
drugs
•
Headquarter
at
Mumbai
•
Headquarter
is
at
Mumbai,
and
offices
are
at
division
&
district
place.
•
Commissioner
is
Head of
Administration.
The
present
commissioner
is
Dr.
Harshadeep
Kamble.
•
Divisional
offices
are
headed
by
Joint
commissioner.
•
District
level offices
are
by
Assistant
commissioner.
Drug
control
laboratory
•
Under Section
20 &
33F of
D
& C rule,
1940
•
DCL
is
at
Mumbai
and
Aurangabad.
Drug Inspector(section
21):
•
The
central
Gov.
&
State
Gov.
by
notification
in
official
gazette
appoints
inspector
prescribed
in under section
21 of
act.
Powers
of
Drug
Inspection
(Sec.22)
•
INSPECT
•
P
r
emise
s
;
bein
g
man
u
f
actu
r
ed;
in
s
pe
c
t
(employees testing
drugs)
•
Any
premises wherein
any
drug
or cosmetic
is
being sold/
stocked/
exhibited/
distributed.
•
Take
samples
of
any
drug/
cosmetic.
•
E
nt
er
&
s
ea
r
ch
a
t
all
r
easonable
ti
m
es,
a
n
y
place,
any
premises.
•
Search
any
person
in connection
with
offence.
•
Examine
any record,
register,
document
or
any
other material
object
found
while
exercising
above
powers.
Duties
of
Drug
Inspector:
•
To
inspect
at least
once
in
year
all
establishments
licensed
for
sale of
drugs
in
area
assigned
to
him.
•
To
investigate
any
complaint
made
to
him.
•
T
o
in
s
titu
t
e
p
r
o
sec
u
tion
i
n
c
ase
of
b
r
ea
c
h
of
acts
&
rules.
•
To
maintain
records related
to
all inspections &
actions
taken
by
him.
•
To
make
inquires
&
inspections.
National
Pharmaceutical
Pricing
Authority
•
NPPA
is an
organization
of
the
Government
of
India
which
was
established,
inter
alia,
to
fix/
revise
the
prices of
controlled
bulk drugs
and
formulations
and
to
enforce
prices
and
availability
of the
medicines in the
country,
under the Drugs
(Prices
Control)
Order,
1995.
Responsibilities:
•
To
implement
and
enforce
the
provisions
of
the
Drugs
(Prices
Control)
Order
in accordance
with the
powers
delegated to
it.
•
to
monitor
the availability
of drugs, identify
shortages,
if
any,
and
to
take
remedial
steps.
•
to
collect/ maintain
data
on
production, exports
and
imports,
market
share
of
individual
companies,
profitability
of
companies
etc,
for
bulk
drugs
and
formulations.
•
to
undertake
and/
or
sponsor
relevant
studies
in
respect
of pricing of drugs/
pharmaceuticals.
References:
•
FDA
Maharashtra(
https://fda.maharashtra.gov.in
/Aboutus.aspx
)
•
CDSCO
(
http://www.cdsco.nic.in/forms/Default.asp
x
)
•
https://en.wikipedia.org/wiki/Drug_Controll
er_General_of_India
•
NPPA
(
http://www.nppaindia.nic.in/
)
Thank
you
Drug Regulatory Authority plays a crucial role in ensuring the quality, safety, and efficacy of pharmaceutical products in India. Governed by both Central and State Governments, key bodies such as CDSCO and DCGI regulate the importation, distribution, and promotion of drugs. Ministry of Health & Family Welfare oversees health policies and family planning programs, while the main goal of drug regulation is to safeguard public health by maintaining standards in drug manufacturing and distribution.
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Presentation Transcript
Drug Regulatory Authority The drug regulatory authority (DRA) is the agency that develops and implements most of the legislation and regulations on pharmaceuticals. Its main task is to ensure the quality, safety and efficacy of drugs, and the accuracy of productinformation. This is done by making certain rules that the manufacture, procurement, import, export, distribution, supply and sale of drugs, product promotion and advertising, and clinical trials are carried out according to specifiedstandards.
Functions of regulatory authority: Product authorization, and monitoring of drug efficacy and safety); Regulation of importation, and distribution; Regulation & Control of drug promotion and information. Adverse drug reaction (ADR)monitoring. Licensing of premises, persons andpractices. Main goal of drug regulation is to guarantee the safety, efficacy and quality of drugs available to public. registration (drug evaluation and drug manufacturing,
It is governed by both Centre and State Governments under the Drugs & Cosmetics Act, 1940. MAIN BODIES: Ministry Of Health & Family Welfare (MHFW) Central Organization(CDSCO) Indian Pharmacopoeia Commission (IPC) Drug Standard Control National Pharmaceutical Pricing (NPPA) Authority
The Ministry (MHFW) government ministry charged with health policy in India. It is also responsible for all government programs relating to family planning in India. The ministry is composed of four departments: Health & Family Welfare; Health Research; AIDS Control; and Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH). Current cabinet minister is Shri. Jagat Prakash Nadda. of Health is and Family Welfare an Indian
CDSCO (Central Drug Standard Control Organization) National Pharmaceuticals and medical devices. Within CDSCO, DCGI (Drug Controller General of India) regulates pharmaceutical and medical devices under gamut of Ministry of Health and Family Welfare ( MHFW). regulatory body for Indian
CDSCO (Vision) To protect and promote public health CDSCO (Mission) To safeguard and enhance the public health by assuring the safety, efficacy & quality of the drugs, cosmetics, medicaldevices. FUNCTIONS: Regulatory control over import, manufacturing, sale & distribution of drugs. Approval of certain drugs & clinicaltrials Meetings of DCC,DTAB Approval for licenses ApprovingAuthority Co-ordination of activities of State Drug Control Organization as Central License
Central Drug Laboratory, Kolkata (CDL) Statutory Lab. Of Gov. Of India over control of Drug & cosmetics act, 1940 Oldest QC lab. Statutory Functions: analytical QC of majority of imported drugs available in Indian market. QC of drugs & cosmetics manufactured in India. Acting as appellate authority in matters relating to quality of drugs.
Other functions: Collection, storage, distribution of International Standards, Int. reference preparation of drugs and p ceutical substances. Training to drug analyst. Training to WHO fellows from abroad on modern methods of druganalysis. Other laboratories: CDTL,Mumbai CDTL, Tamilnadu CDTL,Hydrabad RDTL,Guhawati RDTL,Chandigarh CDL, Kasauli
Indian Pharmacopoeial Commission(IPC) Autonomous institute under MHFW, Gov. of India Dedicated to settings of std. of drugs, p ceuticals and healthcare devices besides providing Ref. Standards and Training. To develop comprehensive monographs for drugs included in IP including API, Excipients and dosage forms. To accord priority to monographs of drugs in the National Essential Drug List & their dosage forms. To accelerate process certification, distribution of IP referencesub. of preparation,
DCGI (Drug Controller General of India) Drug Controller General of India under the gamut of Central Drugs Standard Control Organization is responsible for approval of licenses of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India. Present DCGI is Dr. G. N. Singh
Responsibilities of DCGI: DCGI lay down the standard and quality of manufacturing, selling, import and distribution of drugs in India. Acting as appellate authority in case of any dispute regarding the quality of drugs. Preparation and maintenance referencestandard. To bring about the uniformity in the enforcement of the Drugs and CosmeticsAct. Training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions. Analysis of Cosmetics received as survey samples from CDSCO (central organization). of national drug standard control
DCGI is advised by: DCC(Drug Consultative Committee) Advisory by Central Gov. to advice State Gov. & DTAB Under provision Sec.(3) DTAB (Drug Technical Advisory Board) To advice Central technical arising administration of act. provision Under Sec.(5) State & Gov. matters out on committee of of of
Food & Drug Administration (FDA) Maharashtra s primary consumer. An law enforcement agency. Responsibility of prevention of Food Adulteration Act, 1954 The regulations following independent sections: Drug section Foodsection Food & drug control laboratories instrument of enforcement of the are implemented by
Food & Drug Administration (FDA) Drugs are used to elevate health of people & responsibility for implementation of various rules & regulation for getting safer drugs & cosmetics with good quality & purity to people of the state, is assigned to FDA. For the drug section, implemented by administration; Drugs & Cosmetics Act 1940 & rules there of1945 Drug & Magic Remedies advertisements) Act 1954 Drug Price (Control) Order,1995 Narcotic drugs & Psychotropic SubstanceAct,1985 Poison Act 1919 following acts are (objectionable
Object: To ensure safety, purity, quality of drugs. To prevent consumers from self-medication. To ensure availability of drugs at authorized prices. To create awareness about importance of proper storage of drugs. To eliminate irrational combinations. To prevent misuse of narcotic drugs. To prepare policy regarding drug matter.
Regulate : To grant and renew licenses for the following Categories of Drug Manufacturing Units . AllopathicDrugs AyurvedicDrugs Homeopathic Drugs Unani ,Siddha Medicines Blood ,Blood Products Medical Devices Toapprove Plan of manufacturing premisesfor Drugs. To Grant Licenses for Repacking of Drugs To Grant and Renew Licenses for Drug Selling Units. To Grant Licenses for Public Testing Laboratory.
To issue various Certificates for Tenders, Exports as listedbelow: WHO GMP certificate No Conviction certificate PerformanceCertificate Free Sale Certificate Schedule M GMP Certificate To issue Quota of Narcotics Drugs under the Narcotics Drugs and Psychotropic SubstancesAct. To issue Transport Permits under NDPS Act. To investigate complaints received regarding drugs To carry out inspections of manufacturing and selling Units To draw samples of Drugs To conduct raids for those manufacturing spurious drugs /substandarddrugs
Headquarter is at Mumbai, and offices are at division & districtplace. Commissioner is Head of Administration. Thepresent commissioner is Dr. Harshadeep Kamble. Divisional offices are headed by Joint commissioner. District level offices are by Assistantcommissioner. Drug controllaboratory Under Section 20 & 33F ofD & C rule, 1940 DCL is at Mumbaiand Aurangabad. Headquarter atMumbai
Drug Inspector(section21): The central Gov. & State Gov. by notification in official gazette appoints inspector prescribed in under section 21 of act. Powers of Drug Inspection (Sec.22) INSPECT Premises; being manufactured; (employees testing drugs) Any premises wherein any drug or cosmetic is being sold/ stocked/ exhibited/ distributed. Take samples of any drug/ cosmetic. Enter & search at all reasonable times, any place, any premises. inspect
Search any person in connection with offence. Examine any record, register, document or any other material object found while exercising above powers. Duties of Drug Inspector: To inspect at least establishments licensed for sale of drugs in area assigned to him. Toinvestigate any complaint made to him. To institute prosecution in case of breach of acts & rules. To maintain records related to all inspections & actions taken by him. To make inquires & inspections. once in year all
National Pharmaceutical Pricing Authority NPPA is an organization of the Government of India which was established, inter alia, to fix/ revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country, under the Drugs (Prices Control)Order, 1995. Responsibilities: To implement and enforce the provisions of the Drugs (Prices Control) Order in accordance with the powers delegatedto it. to monitor the availability of drugs, identify shortages, if any,and to takeremedial steps. to collect/ maintain data on production, exports and imports, market share profitability of companies etc, for bulk drugs and formulations. to undertake and/ or sponsor relevant studies in respect of pricing of drugs/ pharmaceuticals. of individual companies,
References: FDA Maharashtra(https://fda.maharashtra.gov.in /Aboutus.aspx) CDSCO (http://www.cdsco.nic.in/forms/Default.asp x) https://en.wikipedia.org/wiki/Drug_Controll er_General_of_India NPPA (http://www.nppaindia.nic.in/)
