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    CH 1 - Class 1 Pharmacutical Jurisprudence

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    wolverine12309
    The document provides an introduction to pharmaceutical jurisprudence and forensic pharmacy. It discusses the definitions and origins of forensic pharmacy and jurisprudence. It also outlines some key functions of drug legislation and regulation including licensing, inspections, and monitoring of drug promotion. Drug laws and regulatory tools are discussed as the foundation for medicine regulation.

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    CH 1 - Class 1 Pharmacutical Jurisprudence

    Uploaded by

    wolverine12309
    7 views13 pages
    The document provides an introduction to pharmaceutical jurisprudence and forensic pharmacy. It discusses the definitions and origins of forensic pharmacy and jurisprudence. It also outlines some key functions of drug legislation and regulation including licensing, inspections, and monitoring of drug promotion. Drug laws and regulatory tools are discussed as the foundation for medicine regulation.

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    Ch 1 - Class 1 Pharmacutical Jurisprudence

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    The document provides an introduction to pharmaceutical jurisprudence and forensic pharmacy. It discusses the definitions and origins of forensic pharmacy and jurisprudence. It also outlines some key functions of drug legislation and regulation including licensing, inspections, and monitoring of drug promotion. Drug laws and regulatory tools are discussed as the foundation for medicine regulation.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    7 views13 pages

    CH 1 - Class 1 Pharmacutical Jurisprudence

    Uploaded by

    wolverine12309
    The document provides an introduction to pharmaceutical jurisprudence and forensic pharmacy. It discusses the definitions and origins of forensic pharmacy and jurisprudence. It also outlines some key functions of drug legislation and regulation including licensing, inspections, and monitoring of drug promotion. Drug laws and regulatory tools are discussed as the foundation for medicine regulation.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 13

    INTRODUCTION TO

    PHARMACEUTICAL
    JURISPUDENCE
    Forensic Pharmacy
    1. The word ‘forensic’ is derived from the Latin term ‘forencis’
    which means “forum”; signifies a public place, market place or
    place of assembly for judicial or other matters

    2. The origin of the term forensic signifies something decided at a


    forum or by the public

    3. Forensic Pharmacy may accordingly be construed as the


    application of pharmaceutical knowledge to legal problems

    4. The approach of student studying forensic pharmacy is different


    from that of a student studying law
    Jurisprudence…
    1. Jurisprudence is study of fundamental legal principles

    2. Jurisprudence includes the knowledge of law

    3. Ethics is the science of human conduct; ideal moral


    code and positive moral code

    4. Jurisprudence serves to train the mind into legal ways


    of thought
    Functions and Purposes of Law

    1. Law is an instrument of society to establish justice

    2. Function and purpose of law is justice, stability and


    peaceful change

    3. Certain degree of flexibility in law is necessary as no


    rule can be made foreseeing all possible cases
    Drug Regulation
    • Legal Structures form the foundation of drug/medicine regulation.

    • Drug laws provide the basis for drug regulation.

    • Regulatory tools such as standards and guidelines equip drug


    regulatory authorities with the practical means of implementing those
    laws.

    • Standards and guidelines should be established in a written form for


    all drug regulatory functions.
    5
    Drug Regulation
    • Regulation of drugs encompasses a variety of functions.

    • Key functions include licensing, inspection of manufacturing facilities


    and distribution channels, product assessment and registration, adverse
    drug reaction (ADR) monitoring, QC, control of drug promotion and
    advertising, and control of clinical drug trials.

    6
    Legislation and Regulation
    • Legislation and Regulation are not the same thing.

    • Legislation refers specifically to creation of new laws.

    • The new laws may be passed by appropriate process at any level of


    government – Central, state or local.

    7
    Legislation and Regulation
    • Laws are written in fairly general terms to meet present and possibly
    future needs.

    8
    Legislation and Regulation
    • Regulations, on the other hand, are rules established
    by an agency that interprets laws.

    • In case of regulations, the responsible agency can


    modify, delete and expand rules within specific
    processes.

    • Regulations can be passed more rapidly and simply


    than laws.

    9
    Guidelines
    • Guidelines do not carry force of law.

    • Can be more easily modified and updated and offer informal


    information as to what government thinks regarding best way of
    implementing the law.

    10
    Drugs & Food Related
    1. The Drugs and Cosmetics Act, 1940.

    2. The Pharmacy Act, 1948 (1959,’76 &’84).

    3. Prevention of food adulteration Act, 1954.

    4. Drugs & Magic Remedies Act 1954.

    5. Narcotics & Psychotropic substances Act 1985

    6. The Drugs (Prices Control) Order 1995.


    Modern Medicine Regulation

    • Started after breakthrough progress in 19th Century lifesciences

    • Unfortunate events led to development of medicine regulations

    • Sulfanilimide Elixir (Diethylene glycol) – 100 people died in the uS

    • Thalidomide disaster
    Why drug regulations?

    • Drugs are not ordinary consumer products

    • Consumers (Patients) not in a position to make a decision

    • Ineffective, harmful, poorly controlled medicine can lead to


    therapeutic failure

    • Medicine regulation – medical, scientific and technical knowledge

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