Transcript Food & Drug Control Administration

Welcomes
FDCA Presentation
D. R. Chauhan
Deputy Commissioner
Food & Drugs Control Admn.
Gandhinagar , Gujarat State
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Overview of FDCA, Gujarat
2
Vision
MISSION
Values
“To safe guard public health”
To boost consumer satisfaction by continuous improvement
of our professional knowledge skill & competence to
explore our potential for discriminating information for public
awareness with Good Governance in all functional area of
Food, Drug & Cosmetics
We work as a team and build partnerships with our
stakeholders by initiative, proactive, and visionary
leadership to having a meaningful and positive impact on
public health with humanity.
We continuously improve upon both what we do and how
we do it.
Incumbency Chart
DIRECTORS, D.C.A.
S. NO.
1
2
3
4
5
NAME
SHRI B. V. PATEL
SHRI S. C. SHAH
SHRI M. R. SHASTRI
SHRI B. M. PATEL
DR. M. A. PATEL
FROM
01-05-60
02-08-72
01-02-75
01-09-78
01-05-79
TO
01-08-72
31-01-75
31-08-78
30-04-79
04-12-79
DIRECTORS, F.D.C.A.
S. NO.
1
NAME
DR. M. A. PATEL
FROM
05-12-79
TO
19-12-85
COMMISSIONERS, F.D.C.A.
S. NO.
1
2
3
4
5
6
7
8
NAME
DR. M. A. PATEL
SHRI A. G. SHAH
SHRI G. R. BHAGAT I/c
SHRI G. R. BHAGAT
SHRI S. P. ADESHARA
MONA KHANDHAR, ( I.A.S. )
DR. S. MURLIKRISHNA, ( I.A.S. )
Dr. H. G. KOSHIA
FROM
20-12-85
01-02-91
01-04-97
19-04-97
01-08-97
07-01-08
28-04-08
22-01-09
TO
31-01-91
31-03-97
18-04-97
31-07-97
05-01-08
27-04-08
22-01-09
Strengths
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The FDCA Gujarat is well managed administration in the country .
It plays pivotal role in modification and amendment of laws and rules.
Department is well-known, for stringent implementation.
Providing prompt and speedy services.
Most deterrent and speediest actions against the wrong doers that is why
state of Gujarat is never a favoured destination for such people.
Most of the officers and ministerial staff are computer friendly.
The department is fully equipped with LAN system and all the district
offices and laboratories are also interconnected by Gujarat state (GSWAN)
system.
For the first time in the country the software for issuing Manufacturing
License through IT application is developed
Online issuing of API & Single Ingredient product licence is already started
and remaining part will be started in short time through IT application.
http://fdca.guj.nic.in/idmla
For the first time in the country we are issuing Sales Licenses through IT
Application. http://xlnfda.guj.nic.in/login.aspx.
FDCA Gujarat Committed to Public health
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Science based regulation of Food & Drugs.
Ensure quality & safety of Food & Drugs.
Positive & pragmatic approach.
Facilitation to manufacturers, traders & citizen by
optimum usage of information technology.
• Constant upgradation of Food & Drug Laboratory – NABL
Accreditation - first Government Laboratory in the country
to get NABL accreditation.
• Training of all officers to achieve the excellence in
execution of their duties.
Good quality of drugs and food made available to the general public is the Goal
of Food & Drugs Control Administration.
The FDCA Gujarat is well managed administration in the country .
It plays pivotal role in modification and amendment of laws and rules.
The Gujarat State FDCA having a 25 District offices , 3 State Laboratories and 3
Corporation Laboratories.
Department is well-known, for stringent implementation.
Providing prompt and speedy services.
Most deterrent and speediest actions against the wrong doers that is why state of
Gujarat is never a favored destination for such people.
Most of the officers and ministerial staff are computer friendly.
The department is fully equipped with LAN system and all the district offices and
laboratories are also interconnected by Gujarat state (GSWAN) system.
Commissioner
25 District Offices
headed by Asst. Commissioner
( DO, SDI, DI, SFSO, FSO )
Head Office
Technical
Administration
Jt. Comm. – 4
Dy. Comm. – 6
Asst. Comm. – 1
Tech. Off. (Ayu) – 2
Designated. Officer. - 1
P.R.O.1
ADMO – 1
L.A. – 1
Assistant Commissioner
DO
Designated Officer
LA
Legal Advisor
FDL
Food & Drug Laboratory
SSA
Senior Scientific Assistant
AC(CS)-1
S.P.O./R.O.2
S.S.O. – 6
J.S.O. – 9
S.S.A. – 27
J.S.A. - 134
E.O. -2
P.A. – 1
A.O. – 1
L.O. – 1
S.D.I. – 8
D.I. – 8
SFSO. – 1
FSO - 7
AC
FDL Vadodara
Food & Drug
Samples Testing
Laboratory
Joint Commissioner
(Testing)
R.F.L.Bhuj
(Food
Samples
Testing)
R.F.L.
Rajkot
(Food
Sample
Testing)
S.S.O. – 1
J.S.O. – 1
S.S.A. – 2
J.S.A. - 7
J.S.O. - 1
S.S.A. – 1
J.S.A. - 8
SDI
Senior Drugs Inspector
DI
Drugs Inspector
T.O. (Ayu)
Technical Officer (Ayurvedic)
SFSO
Senior Food Safety Officer
FSO
Food Safety Officer
AO
Account Officer
LO
Legal Officer
SPO
Statistics & Planning Officer
RO
Research Officer
RFL
Regional Food Laboratory
SSO
Senior Scientific Officer
JSO
Junior Scientific Officer
JSA
Junior Scientific Assistant
PRO
Public Relation Officer
ADMO
Administrative Officer
FDCA Team
Class IV
239
18%
Class I
91
Class II
7%
216
16%
Class I
Class II
Class III
Class III
777
59%
Class IV
Total 1323
7 New Circle Offices Commenced in 2010-2012
FDCA Circle Offices : 18 + 7= 25
FDCA, Gujarat
Committed to Public Health
Positive & pragmatic approach.
Facilitation to manufacturers, traders & citizen by optimum usage of information
technology.
Constant up gradation of Food & Drug Laboratory – NABL Accreditation-first
Government Laboratory in the country to get NABL accreditation.
Training of all officers to achieve the excellence in execution of their duties.
Science based regulation of Food & Drugs.
Ensure quality & safety of Food & Drugs.
FDCA - Main functions
To regulate the manufacture,
distribution and sale of Food , Drugs
(Allopathic, Ayurvedic, Homeopathic),
& Cosmetics.
To investigate the
To grant and renew Licenses of
complaints received
Food & Drugs Establishments,
from public for
including additional product
Food and Drugs
license.
articles.
To analyze the
samples of Food
and Drugs articles.
To draw Samples of
Food and Drugs
articles.
To issue various
certificates like
WHO-GMP,
GMP,FSC, NCC,
COPP… etc.
Inspections of
Manufacturing and
Sales Units of Food &
Drugs.
FDCA – Laboratory capabilities
Food and Drug Laboratory (FDL) –
Vadodara, Regional Food
Laboratory - Rajkot, Bhuj are well
equipped to carry out testing of:
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Allopathic drugs
Ayurvedic drugs
Homeopathic drugs
Cosmetics
Food articles
These laboratories are equipped
with state of the art testing
facilities having key sophisticated
instruments including:
• AAS
• Spark emission
spectrophotometers
• HPLC with Auto Sampler
• Gas/Liquid chromatography
• Spectrophotometers
• FTIR
Acts implemented by FDCA, Gujarat
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FOOD & DRUGS CONTROL ADMINISTRATION
IMPLEMENTS FOLLOWING ACTS & RULES
Central Acts.
 Drugs & cosmetics Act 1940
 Drugs & Cosmetics rules 1945.
 Food Safety and Standarad Act, 2006
 Food Safety and Standard Rules, 2011
 Drugs ( Price Control ) Order 1995.
 Drugs & Magic Remedies ( objectionable advertisement ) Act 1954.
 Drugs & Magic Remedies (objectionable advertisement) rules 1955.
 Cigarettes & other tobacco products ( prohibition of advertisement
and regulation and trade and commerce production, supply and
distribution ) Act 2003
Drugs & cosmetics Act 1940 and Drugs &
Cosmetics rules 1945.
An Act to regulate the import, manufacture,
distribution and sale of drugs and cosmetics.
Drugs ( Price Control ) Order 2013
Order under section 3 of Essentail Commodities
Act, 1955 to fix & regulate ceiling prices of
certain API & formulations
Drugs & Magic Remedies ( objectionable
advertisement ) Act 1954 &
Drugs & Magic Remedies (objectionable
advertisement) rules 1955.
An Act to control the advertisement of drugs in
certain cases, to prohibit the advertisement for
certain purposes of remedies alleged to possess
magic qualities and to provide for matters
connected therewith.
FDCA IMPLEMENTS FOLLOWING ACTS & RULES
Central Acts.
 Food Safety & Standards Act, 2006
 Food Safety & Standards Rules , 2011
 Food Safety & Standards Regulations, 2011
An Act to consolidate the laws relating to food and to establish the Food
Safety and Standards Authority of India for laying down science based
standards for articles of food and to regulate their manufacture, storage,
distribution, sale and import, to ensure availability of safe and wholesome
food for human consumption and for matters connected therewith or
incidental thereto.
Food Safety and Standarad Act, 2006
Food Safety and Standard Rules, 2011
Food Safety & Standards Regulations, 2011
An Act consolidate the laws relating to Food and
to establish the Food Safety and Standards
Authority of India for laying down science based
standards for articles of Food and to regulate
their manufacture, storage, distribution, sale and
import, to ensure availability of safe and
wholesome food for human consumption and for
matters connected therewith or incidental
therto.
Cigarettes & other tobacco products ( prohibition
of advertisement and regulation and trade and
commerce production, supply and distribution )
Act 2003
An Act to prohibit the advertisement of, and to
provide for the regulation of trade and
commerce in, and production, supply and
distribution of,cigarettes and other tobacco
products and for matters connected therewith or
incidental thereto
Statistical Information
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Drug establishments in Gujarat State
The details of manufacturing units in the Gujarat State as on 4TH September 2013.
Allopathic
Ayurvedic
Cosmetics
Homeopathic
Total
2313
625
394
8
3339
The details of Sales units in the Gujarat State as on 4TH September 2013.
Retail
Wholesale
Retail / Wholesale
Total firms
13689
12094
3132
28915
Drug Samples
2009 – 2010
2010 – 2011
Total
Sample
NSQ % NSQ
Total
Sample
NSQ
% NSQ
2567
325 12.66 %
5037
317
6.29 %
2011 – 2012
2012-13
Total
Total
NSQ % NSQ
Sample
Sample
5796
463
7.99 %
6838
NSQ
% NSQ
381
5.57%
e- Governance & proactive services
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Web Portal
Link
FDCA’s Web site
http://gujhealth.gov.in/food_drug
Sales License Software
http://xlnfda.guj.nic.in
Manufacturing License Software –
For Manufacturer
http://idmla.guj.nic.in
Manufacturing License Software –
For FDCA Officers
http://dmla.guj.nic.in
Online Complaint Module
http://gujhealth.gov.in/complaint
Toll free Number
1800 233 5500
Other States intergration
Online Complaint
Preliminary Testing Kit : The kit has 21 items for testing of food articles like synthetic
milk, oil, tea, milk, sweet, ghee.
Mobile Exhibition & Testing Vans
Awards & Accreditations
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Government of Gujarat "To make public Services efficient and corruption free" rewards its
various departments for their exemplary initiatives. During March 2012, Dr. H. G. Koshia
Commissioner, FDCA, Gujarat was awarded the first award under above category for the FDCA,
Gujarat's initiative of XLN - Xtended Licensing & Laboratory Node, and its impacts.
National e-Governance Gold Award in Year 2013 at Jaipur.
CSI IT-Excellence Award for the Health Sector at Kolkatta.
XLN identified amongst the 2 Projects for the National level Rapid Roll-Out
Project by the Ministry of IT & Communications, New Delhi.
Government Initiative Health Care Sector eINDIA – 2013 Award at Hyderabad
Awards received by Govt. of Gujarat for NABL
Gold Awards received by Govt. of Gujarat for e-Governance
CSI Awards received by Govt. of Gujarat for e – Governance
e-India Awards for e – Governance (XLN module)
ખોરાક અને ઔષધ પ્રયોગશાળા, વડોદરાએ “ નેશનલ એક્રેડીટેશન બોડડ ફોર ટે સ્ટીગ એન્ડ કેલીબ્રેશન લેબોરે ટરી, નવી દદલ્હી ” દ્વારા “
બાયોલોજીકલ અને કેમીકલ ટે સ્ટીગ વિભાગ ” માટે ઉપર મુજબના એન.એ.બી.એલ. સટીફીકેટ ( અંગ્રેજી ) મેળવેલ છે . આ પ્રમાણપત્ર
મેળવનાર સમગ્ર દે શમાની પ્રથમ સરકારી પ્રયોગશાળા છે .
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