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
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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.

  • Drug Regulatory Authority
  • CDSCO
  • DCGI
  • Ministry of Health
  • Family Welfare

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  1. Central and State Drug Regulatory Bodies

  2. 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.

  3. 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,

  4. 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

  5. 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

  6. 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

  7. Locations(CDSCO) :

  8. 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

  9. 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.

  10. 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

  11. 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,

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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.

  18. 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.

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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,

  24. 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/)

  25. Thank you

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