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.
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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.

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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.

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

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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.

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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.

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 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