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    Chapter 8 Part 2 D and C Act Continued..

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    Aminul Islam
    The document discusses various administrative bodies constituted under the Drugs and Cosmetics Act of 1940 in India. It outlines three types of bodies: 1) Advisory bodies like the Drugs Technical Advisory Board and Drugs Consultative Committee, 2) Analytical bodies like the Central Drugs Laboratory and State Drugs Testing Laboratories, and 3) Executive bodies like the Central Drugs Control Department and State Drugs Control Department. It provides details on the composition, functions, and role of these different bodies in implementing and enforcing the Drugs and Cosmetics Act.

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    Chapter 8 Part 2 D and C Act Continued..

    Uploaded by

    Aminul Islam
    52 views8 pages
    The document discusses various administrative bodies constituted under the Drugs and Cosmetics Act of 1940 in India. It outlines three types of bodies: 1) Advisory bodies like the Drugs Technical Advisory Board and Drugs Consultative Committee, 2) Analytical bodies like the Central Drugs Laboratory and State Drugs Testing Laboratories, and 3) Executive bodies like the Central Drugs Control Department and State Drugs Control Department. It provides details on the composition, functions, and role of these different bodies in implementing and enforcing the Drugs and Cosmetics Act.

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    Chapter 8 Part 2 d and c Act Continued..

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    The document discusses various administrative bodies constituted under the Drugs and Cosmetics Act of 1940 in India. It outlines three types of bodies: 1) Advisory bodies like the Drugs Technical Advisory Board and Drugs Consultative Committee, 2) Analytical bodies like the Central Drugs Laboratory and State Drugs Testing Laboratories, and 3) Executive bodies like the Central Drugs Control Department and State Drugs Control Department. It provides details on the composition, functions, and role of these different bodies in implementing and enforcing the Drugs and Cosmetics Act.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    52 views8 pages

    Chapter 8 Part 2 D and C Act Continued..

    Uploaded by

    Aminul Islam
    The document discusses various administrative bodies constituted under the Drugs and Cosmetics Act of 1940 in India. It outlines three types of bodies: 1) Advisory bodies like the Drugs Technical Advisory Board and Drugs Consultative Committee, 2) Analytical bodies like the Central Drugs Laboratory and State Drugs Testing Laboratories, and 3) Executive bodies like the Central Drugs Control Department and State Drugs Control Department. It provides details on the composition, functions, and role of these different bodies in implementing and enforcing the Drugs and Cosmetics Act.

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    of 8

    CHAPTER - 8 PART 2

    D and C Act 1940


    Various administrative bodies constituted / appointed
    under the Act:
    For the purpose of efficient implementation and administration of the D
    and C Act, the following agencies have to be constituted by the Central
    Government / State Governments.

    I. Advisory Bodies:
    1. Drugs technical advisory board (DTAB)
    2. Drugs consultative committee(DCC)

    II. Analytical Bodies:


    3. Central Drugs laboratory (CDL)
    4. State Drugs testing laboratories
    5. Government analyst

    III. Executive Bodies:


    6. Central Drugs control Department Licensing Authorities
    7. State Drugs control Department
    8. Drugs Inspector

    I. ADVISORY BODIES:
    Drugs Technical Advisory Board
    Constitution and Functions of Drugs Technical Advisory Board
    (DTAB)

    Constitution: it is constituted by the Central Government under section 5

    SE & OE YRS Page 1


    of D and C act 1940 for a term of 3 years each time; It is constituted with
    the following elected, Nominated and Ex- officio members.

    A. Elected Members:
    1) One person to be elected by P.C.I from amongst the teachers in
    pharmacy or pharmaceutical chemistry or pharmacognosy of an
    recognized pharmacy college or university
    2) One person to be elected by M.C.I from amongst the teachers in
    medicine of a recognized medical college or university.
    3) One pharmalogist to be elected by the governing body of Indian
    council of Medical Research (ICMR).
    4) One person to be elected by Indian Pharmaceutical Association
    (IPA).
    5) One person to be elected by Indian medical association from
    amongst its members (IMA).
    B. Nominated Members: (by Central Government)
    6) Two persons to be nominated from amongst the Drugs controllers of all
    the States.
    7) One person to be nominated from the pharmaceutical industry.
    8) Two Government analysts to be nominated from amongst Government
    analysts of Central Drugs laboratory and State Drugs testing laboratories.
    Ex- Officio Members:
    9) The director general of the health services (Central health Department)
    who shall be the chairman of the board.
    10) The Drugs controller general of India of Central Drugs control
    Department
    11) Director of the Central Drugs Laboratory (CDL) Kolkata
    12) Director of the Central Research institute, Kasouli
    13) Director of the Central Drugs Research Institute, Lucknow

    SE & OE YRS Page 2


    14) Director of the Indian veterinary Research Institute, Izatnagar
    15) President of the pharmacy council of India (PCI)
    16) President of the Medical council of India (MCI)

    Members hold the office for a period of 3 years, they are eligible for re-
    nomination and reelection, any member can resign during the term from
    his membership. Any vacancies of members created due to resignation or
    death can be filled up only for the remaining period. the members can
    constitute an executive committee and subcommittees for varies
    purposes. The Board can appoint a registrar or secretary and sufficient no
    of officials for day to day functioning of the Board and fix their salaries.

    Functions:
    1) To advise Central/ State Governments on various technical matters
    arising out the administration of D and C act:
    2) To advise / suggest about any amendments to Drugs and
    Cosmetics.
    3) To carry out any other functions entrusted to it by the Central
    Government related to D and C act.

    Drugs Consultative committee: (D.C.C)


    The Drugs consultative committee is constituted by the Central
    Government under section 7 of the D and C act . it is constituted with the
    following members :
    1) Two representatives of the Central Government to be nominated by
    the Central Government.
    2) One representative of the State Government to be nominated by the
    concerned State Governments

    SE & OE YRS Page 3


    Functions of the Drugs Consultative Committee:-
    1) To advise /suggest the Central Government and the State
    Governments and also D.T.A.B, about ensuring uniformity in enforcement
    of the Drugs and Cosmetics act entrusted and its rules.
    2) To carry out any other functions entrusted to the act by the Central
    Government which are related the Drugs and Cosmetics.

    II. ANALYTICAL BODIES:


    1) Central Drugs laboratory (C.D.L): it is established by the Central
    Government under section 7 of D and C act 1940. It is established in
    Kolkata and consists of a Director and sufficient no of officers for the
    laboratory.

    Functions of the CDL:-


    a) To carry out analysis of samples of Drugs and Cosmetics sent to it
    by the customs officers.
    b) To carry out analysis and assay of samples of Drugs sent to it by
    the courts.
    c) To carry out any other functions entrusted to it by the Central
    Government.
    The samples of vaccines sera and others biological prepns are analyzed
    at Central research institute, Kasauli on behalf of C.D.L
    The samples of polio vaccines are analyzed at polio vaccine testing
    laboratory of Central research institute on behalf of C.D.L
    The samples of Veterinary Drugs are analyzed at Indian Veterinary
    research Institute, Izatnagar on behalf of C.D.L.
    The samples of mechanical contraceptives are analyzed at the Central

    SE & OE YRS Page 4


    Indian pharmacopeia laboratory, Ghaziabad on behalf of C.D.L
    The samples for Human Blood and plasma etc. are analyzed at the
    National Institute of Virology – Pune
    The samples for analysis should be sent in sealed packing by Registered
    post to the concerned Directors of the laboratories. officers in charge of
    the lab shall receive the samples, check for the sealed packings and carry
    out the analysis and assay of the samples as per the protocol, and submit
    the report to the director, who after checking the report, puts his signature
    alsoand send the report confidentially by Registered Post to the person
    who has sent the sample for analysis. Such a report is considered as
    official and authentic by the court of law as per the act.

    2) State Drugs Testing Laboratories:

    Each and every State Government shall establish the State Drugs testing
    laboratories or Government Drugs testing laboratories with a Director or a
    superintendent and sufficient no of Government analysts to the laboratory.
    Private Drugs testing laboratories are also permitted to be established
    under the act. The main function of the State Drugs testing laboratory is
    to carry out the analysis and assay of samples of Drugs and Cosmetics
    sentto it by the Drugs Inspectors and submit its report to the Inspectors. It
    can also carry out the analysis of Drugs sent to it by any individuals or
    manufacturing units on payment of the prescribed fee and submit its report
    to the concerned persons. such analysis and assay of the samples of
    Drugs and Cosmetics received by the laboratory is carried out by the
    Government Analysts of the laboratory.

    3) Government Analysts:

    SE & OE YRS Page 5


    A Government analyst is appointed by the Central Government or State
    Government under section 20 of the D and C act, for the purpose of
    analyzing the samples of Allopathic Drugs and cosmists and under section
    33-F for analyzing and testing the samples of Ayurvedic, Unani and siddha
    system of medicines. A Government analyst appointed should not have
    any financial interest or business of his own in Import, manufacturing and
    sale of Drugs and Cosmetics or other types of private business. A
    Government Analyst is a ‘Public Servant’ Under Section 21 of the Indian
    Penal Code (IPC) and all terms and conditions prescribed for a ‘Public
    Servant’ shall also apply to Government Analyst.

    I. Qualifications prescribed for the appointment of a


    Government analyst:
    Following are the Qualifications prescribed for the Appointment as
    Government Analyst:-

    1) A Graduate / Degree in pharmacy or Medicine or Science of a


    recognized college / University with at least 5 years of post graduate
    experience in analyzing and testing the samples of Drugs and Cosmetics
    under a Government analyst or under the Head of in approved Drugs
    testing laboratory.
    OR

    2) A Post Graduate Degree in Pharmacy or Medicine or Science of a


    recogsnised college / University with at least 3 years of post graduate
    experience in analysing and testing the samples of Drugs and Cosmetics
    under a Government analyst or under the head of an approved Drugs
    testing laboratory
    OR

    SE & OE YRS Page 6


    3) An associate ship Diploma of the Institution of chemists (India) with
    “Analysis of Drugs and Pharmaceuticals” as one of the subjects studied
    with not less than 3 years of experience in the analysis and assay of Drugs
    and Cosmetics under a Government analyst or under the Head of an
    approved Drugs testing lab.

    OR
    4) For the purpose of analyzing and testing the samples of veterinary
    Drugs, a person should have any one of the above mentioned Educational
    Qualifications with not less than 3 years to5 years of experience
    respectively in analysing and testing the samples of veterinary Drugs.
    OR
    5) For the purpose of analyzing and testing the samples of biological
    and special prepns like vaccines, sera etc. mentioned under schedule C
    and C1, of D and C Act, a Person with any one of the above Educational
    Qualifications with not less than 3 Yrs to 5 yrs respectively of experience
    in testing and analyzing such samples under a Government analyst or
    under the head of an approved Drugs testing laboratory.

    II. Duties of a Government analyst:


    Following are the duties of a Government Analyst
    1) To analyze and test the samples of Drugs and Cosmetics received
    by him form Drugs Inspector or other persons and forward the report to
    the concerned persons who have sent the samples to him.
    2) To carry out any Research work and publish the articles of Research
    after obtaining permission from the Director or the Head of the Drugs
    testing laboratory.
    3) To carry out any other duties entrusted to him by his superior officers
    related to testing and analyzing, different types of Drugs and Cosmetics.

    SE & OE YRS Page 7


    SE & OE YRS Page 8

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