Introduction

Overview

Drugs Control Administration (DCA), Gujarat came into existence on 1st May 1960 after separation of Gujarat State from Greater Bombay State and Mr. B.V. Patel became the first director of DCA, Gujarat.

DCA, Gujarat was entrusted implementation of Drugs & Cosmetics Act 1940 & Rules 1945 and Drugs Magic Remedies (Objectionable Advertisement) Act 1954. Mr. B.V. Patel played a vital role in establishing well defined administrative structure, policies and procedures of DCA, Gujarat. He seeded the present culture of this department industry friendly, prompt & strict action against law breakers. He also took initiative to establish state of art Drug Laboratory equipped with latest equipments at Vadodara.

In the fond memory of legendary person Mr. B.V. Patel, prestigious education & research centre was named & inaugurated – "B.V. Patel Pharmaceutical Education & Research Centre” at Ahmedabad in October 1990. He is the only Government Officer whose name has been associated with such institute.

SHRI S. C. Shah, SHRI M. R. Sharshtri, SHRI B. M. Patel and Dr. M. A. Patel followed Mr. B. V. Patel as Director of DCA, Gujarat.

During the tenure of Dr. M.A. Patel, Director of DCA, Gujarat, considering the performance of DCA, Gujarat, Government of Gujarat entrusted one more responsibility of implementation of "Prevention of Food Adulteration Act,2006”(FSSA) and the department was renamed as "Food & Drugs Control Administration” (FDCA) w.e.f. 5th December, 1979 & Dr. M.A. Patel became the first Director of FDCA, Gujarat. A separate wing of Food Inspectors & Senior Food Inspectors was formed at all Circle Offices and head office for the implementation of FSSA.

FDCA Implementing Various Act

http://cdsco.nic.in/forms/contentpage1.aspx?lid=1888

At present FDCA, Gujarat is implementing following act and rules in Gujarat through two wings–food cadre & drug cadre officers.
  • 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 essential commodities act, 1955 to fix & regulate ceiling prices of certain API & formulations DPCO WEB UPDATE SCHEDULE DRUGS FOR WHICH PRICE FIXED BY NPPA
  • 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
  • Food safety and standards act, 2006 and food safety and standard rules, 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 there to.
  • 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.

    Testing Laboratories

    Food & Drug Laboratory (FDL), Vadodara is the first NABL accredited Government laboratory in the country. In addition to FDL, Vadoadara, FDCA has two other Regional Food Laboratories for testing of food samples, one at Rajkot and one at Bhuj. FDCA is also setting up one more state of art Food & Drug Laboratory at Dethali, Dist. Patan, North Gujarat. This new FDL lab is designed as per latest GLP norms, with latest equipments & instrument

    Constant up gradation of facilities & equipment in laboratories have always been on priority of FDCA, Gujarat

    Training

    Training of FDCA officers of both cadres, Drug & Food, has been a regular practice. it includes induction training of newly appointed officers and in service training as well. the objective of training is to sharpen their knowledge not only to maintain performance of FDCA but also to achieve newer landmarks

    Organization Structure

    FDCA Gujarat Team

    Class I II III IV Total
    Number of Post 91 216 777 239 1323

    Decentralization of Powers

    • Commissioner, FDCA is the Licensing Authority & Controlling Authority under Drugs & Cosmetic Act - 1940
    • Commissioner, FDCA has delegated powers of Licensing Authority for Cosmetics & Homeopathy manufacturing to Joint Commissioner (Drug)
    • Joint Commissioner (Ayurved) has been notified as Licensing Authority for Ayurvedic Drug Manufacturing
    • Commissioner, FDCA has delegated powers of Licensing Authority for drug sales licenses to all Assistant Commissioners for the districts allocated to them

    Thus, for smooth and efficient working, decentralization of powers has been worked out. However, Commissioner, FDCA monitors the entire activities as Controlling Authority

    FDCA Circle Offices

    At present 25 Circle offices in various districts and they ensure implementation of above acts in the districts allocated to them.Drugs Inspectors of circle offices have been assigned duties to inspect pharma dealers & they submit their reports to concerned Assistant Commissioner of the circle.

    Drugs Inspectors & Senior Drugs Inspectors of circle offices regularly draw samples of allopathic drugs, ayurvedic drugs, homeopathic drugs, cosmetics and raw materials used to manufacture them from dealers, manufacturing units, doctors, hospitals, CHC, PHC etc. and send them to Food & Drug Laboratory, Vadodara for testing & analysis of the samples. If the sample is declared of "Not of Standard Quality”,they initiate actions as per the policy of the department &as per the provisions of Drugs & Cosmetics Act – 1940 & rules the runder and report to head office.

    Circle Offices constantly keep vigilant watch to prevent & curb menace of habit forming drugs and carry out raids to take strict actions against law defaulter.Assistant Commissioners & Senior Drugs Inspectors inspect pharmaceutical & cosmetics manufacturing units and submit their reports to Commissioner, FDCA. Assistant Commissioners & Senior Drugs Inspectors also jointly inspects following categories of units with officers of CDSCO under CLAA scheme/WHO GMP.

    • Blood Banks & Blood Components
    • Large Volume Parenterals Manufacturing Units
    • Sera & Vaccines Manufacturing Units
    • DNA / Biotech products Manufacturing Units
    • New Medical Devices Manufacturing Units
    • Inspection for grant of WHO GMP Certificates

    FDCA Head Office

    With the help of senior level officers, Head Office constantly monitors working of circle offices.Process applications for grant of manufacturing Licenses, product licenses, approvals of technical persons, grant of various certificates like WHO GMP, Sate GMP, COPP, FSC, Non conviction certificates etc., take actions for NSQ test reports and inspection reports of manufacturing unit.

    Intelligence Branch (IB) headed by Deputy Commissioner (IB), keeps vigilant watch and in co-ordination with circle offices, takes prompt actions on any information related manufacturing / selling of spurious, misbranded or drug/cosmetics manufactured without licenses.

    • FDCA, Gujarat has a complaint module on its web site to enable citizens to send online complaint regarding drug and food
    • FDCA, Gujarat also has 24X7 toll free services for citizens to register the complaint telephonically

    Statistical Information

    Food & Drug Establishments in Gujarat

    The Details of Manufacturing Units in Gujarat as on 5th July 2014
    Allopathic Ayurvedic Cosmetics Homeopathic Total
    2249 627 369 08 3253
    The Details of Sales Units in Gujarat as on 9th October 2013
    Retail Wholesale Retail/Wholesale Total
    14468 12627 3043 30338

    Drug Samples

    2010-2011 2011-2012 2012-2013 2013-2014
    Total NSQ %NSQ Total NSQ %NSQ Total NSQ %NSQ Total NSQ %NSQ
    4465 317 6.29% 5333 463 7.99% 6832 381 5.58% 9713 567 5.84%

    E-Governance

    FDCA, Gujarat makes optimum use of information technology for achieving excellence in performance.FDCA, Gujarat is the first State to initiate online software for sales & manufacturing licenses. After successful implementation of Sales Licensing Software since 1st January 2007 and with proven sustainability of the software,Drugs Controller General India(DCGI),Government of India praised and recommended this software to all State Drugs Controllers at several occasions.In turn,Drugs Controllers of other states requested Government of Gujarat to provide Gujarat Model of the software. Till date four stated namely,Maharashtra,Karnataka,Kerala & Andhra Pradesh have started implementation recently and other six states namely Madhya Pradesh, Goa, Himachal Pradesh, Chennai, West Bengal & Chattisgadh are in the process of implementations.

    Web Portal Links
    FDCA’s Web site https://gujhealth.gujarat.gov.in/food_drugExternal website that opens in a new window
    Sales License Software http://xlnindia.gov.in/External website that opens in a new window
    Manufacturing License Software–For Manufacture http://idmla.guj.nic.inExternal website that opens in a new window
    Manufacturing License Software–For FDCA Officers http://dmla.guj.nic.inExternal website that opens in a new window
    Online Complaint Modul https://gujhealth.gujarat.gov.in/complaintExternal website that opens in a new window

    Awareness Programs

    • Commissioner FDCA and other senior level officers periodically give informative programs, interviews / demonstration of testing kits on Doordarshan, other television channels and All India Radio.
    • An informative & educative presentation–"Drug–‘Dev’ or Devil,depends on how you consume”–has been prepared by head office and has been sent to all circle offices for periodically arranging awareness programs at various schools and colleges to educate and sensitize youngsters regarding hazards of misuse of drugs.
    • At each and every district of the State, periodically workshops have been arranged by senior officers of head office,Assistant Commissioners and officers of Food cadre to educate & sensitize food business operators(FBO) regarding hygiene practices and provisions of FSSA.
    • A special Food Testing Kit has been devised by FDCA, Gujarat to verify whether certain food items are adulterated or not. Such kits have been made available at all 25 circle offices and have also been distributed to NGOs.
    • Two Exhibition Vans and one Sample Testing Van equipped with necessary equipments, testing kits, exhibition materials, audio-visual displays etc.
    • The details of sample declared as "Not of Standard Quality” (NSQ) is sent through SMS to all retailers, wholesalers, District Health Officers (DHO),PHC / CHC, CMSO and State Drugs Controllers of India.This SMS is done at a click of a mouse by the Asst Commissioner (I.B.)from head office.

    Example of NSQ Alert Message

    FDCA-GJ Alert:"XYZ” TABLETS Batch:AB-03 Mfg:04-2011, Exp:03-2014 Mfg by:ABCDEF LABORATORIES declared SUBSTANDARD,STOP USE/SALE/DISTRIBUTION,RECALL URGENTLY...

    This is the first ever initiative taken by any Drugs Controller to ensure effective recall of NSQ medicines.

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