Welcomes FDCA Presentation D. R. Chauhan Deputy Commissioner Food & Drugs Control Admn. Gandhinagar , Gujarat State 1 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 • • • • • • • • • • 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 • • • • 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: • • • • • 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 15 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 22 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 24 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 34 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 . 43