Easy to Learn

PHARMACEUTICAL
JURISPRUDENCE
For Competitive Examination

Theory & Practice Book

GPAT | NIPER | DRUG INSPECTOR | PHARMACIST

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Practice Book for Pharmaceutical Jurisprudence

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DISCUSSION
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 CONTENT
S.NO. PHARMACEUTICAL JURISPRUDANCE PAGE NO.
1. HISTORY OF DRUG LEGISLATION IN INDIA 1-2
2. PHARMACEUTICAL ETHICS 3-5
3. PHARMACY ACT 6-12
4. ALL INDIA COUNCIL FOR TECHNICAL EDUCATION 13-15
(AICTE) ACT
5. DRUG AND COSMETIC ACT AND RULE 16-32
6. THE NARCOTIC DRUG AND PSYCHOTROPIC SUBSTANCE 33-35
ACT
7. THE MEDICINAL AND TOILET PREPARATION ACT AND 36-42
RULE
8. DRUG AND MAGIC / REMEDIES ACT AND RULE 43-44
9. THE DRUG (PRICE CONTROL) ORDER 2013 45-48
10. INSECTICIDE ACT AND RULES 49-52
11. POISONS ACT 53-54
12. MEDICAL TERMINATION OF PREGNANCY ACT AND RULE 55-57
13. PATENT ACT 58-61
14. DESIGN ACT AND RULES 62-64
15. TRADE MARKS ACT 65-69
16. FACTORIES ACT 70-73
17. MINIMUM WAGES ACT 74-76
18. PREVENTION OF CRUELTY TO ANIMAL ACT 77-78
19. ICH GUIDELINES 79-83
20. WORLD HEALTH ORGANIZATION (WHO) 84-86
21. PHARMACOPOEIA (I.P, B.P., U.S.P) 87-91
22. CENTRAL DRUG STANDARD ORGANIZATION (CDSCO) 92-94
23. INVESTIGATIONAL NEW DRUG APPLICATION (INDA) 95-98
24. U.S. FOOD AND DRUG ADMINISTRATION (FDA) 99-103
25. ORGANIZATION FOR ECONOMIC CO-OPERATION AND 104-106
DEVELOPMENT (OECD)
26. PHARMACEUTICAL JURISPRUDENCE MCQ 107-148
 5 DRUGS AND COSMETICS
ACT AND RULES

INTRODUCTION
 Drugs and Cosmetics Act was passed on10th April 1940 & Rule in 1945 by the Indian Legislature.
 This Act was amended in1955 by the Indian Parliament and Subsequently amended in 1960,
1962, 1964, 1972, 1982, 1986, 1995, 2000, 2008, 2011 and 2018.

OBJECTIVE
 This is an act to regulate the import, manufacture, distribution and sales of drugs.
TheAct consists of five chapters:
 Chapter I- Introductory
 Chapter II - Administrative bodies
 Chapter III- Import of drugs and cosmetics
 Chapter IV- Manufacture, sale and distribution of drugs and cosmetics
 Chapter IV-A Provisions relating toAyurvedic, Siddha and Unani drugs
 ChapterV- Miscellaneous

CHAPTER I- INTRODUCTORY
 Drug and cosmetic rules have been divided into 18 parts, each dealing with particular subjects.
 There are 2 schedule to the act and 23 schedule to the rules,
SCHEDULE TO THE ACT

1. First Schedule: It prescribes the list of books specified in Ayurvedic, Siddha or Unani systems
of medicine.
2. Second Schedule: It prescribes the standards to be complied with by imported drugs and
by the drugsmanufactured for sale, sold stocked or exhibited for sale or distributed.
In addition, the following appendix are also prescribed:
Appendix:
I- Data required to be submitted with application for permission to market a new drugs.
II- Format for submission of clinical trial reports.
III- Animal toxicity requirement for clinical trial and marketing of a new drugs.
IV-Number of animals for long term toxicity studied.
V- Patient consent form for participation in a phase I clinical trials.
VI- Four groups of fixed dose combination and their data requirements.
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SCHEDULES TO THE RULES

A- Performa for application for the licenses, issues and renewal of licenses, for sending
memoranda under the Act.
B -Rates of fee for test or analysisby the Central Drugs Laboratory or the state drug laboratories
B1- Fee for the test or analysis by the pharmacopeia laboratory for Indian medicine or the
govt. analyst.
C - List of biological and other special products whose import, sale, distribution and
manufacture are governed by special provision.
C1- List of other special products whose import, sale, distribution and mfg are governed by
special provision.
D- List of drugs exempted from the provisions to import of drugs.
E1- List of poisonous substances under the Ayurvedic (including Sidha) and Unani systems
of medicine.
F – Requirement for the functioning and operation of the blood bank and/or for prepration
of blood components.
F1-
Part I - Provisions applicable to the production of all bacterial and viral vaccine.
Part II - Provisions applicable to the production of all sera from living animal.
Part III - Provisions applicable to the manufacture and standardization of diagnostic
agent (Bacterial origin)
F2- Standards for surgical dressings.
F3- Standards for sterilized umbilical tapes.
FF- Standards of ophthalmic preparations.
G- List of substances that are required to be used only under medical supervisionand which
are to be labeled accordingly.
H- List of prescription drugs.
J- Disease or ailmentswhich a drug may not purport to prevent or cure.
K- Drugs exemptedfrom certain provision relating to manufacture of drugs.
L-Good laboratory practice (GLP)and requirement of premises and equipment.
M - Good manufacturing practice (GMP) requirement of factory premises, plants and
equipment.
M1- Requirement of factory premises etc. for manufacture of homoeopathic preparation.
M2- Requirement of factory premises etc. for manufacture of cosmetics.
M3 - Requirements of factory premises for the manufacture of medical devices.
N - List of minimum equipment for efficient running of a pharmacy.
O - Standard for disinfectant fluid.
P- Life period of drug.
P1 - Pack sizes of drugs.
Q - List of coals tar colors permitted to be used in cosmetics.
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 GPAT DISCUSSION CENTER
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R - Standard for condoms made of rubber latex and other mechanical contraceptives.
R1- Standard for mechanical contraceptive.
S - Standard for cosmetics.
T - Good manufacturing practice for Ayurvedic Siddha, Unani medicines.
U - Particulars to be shown in manufacturing records.
U1 - Particulars to be shown in manufacturing, raw material and analytical records of
cosmetic
V - Standard for patent or proprietary medicines.
W - List of drug which is to be marketed under generic names only.
X - List of drugs whose import, manufacture and sale, labeling and packaging are governed by
special provision.
Y - Requirement and guideline for permission to import and manufacture of new drugs for sale
or to undertake clinical trial.
IMPORTANT AMENDMENTS

1982 : Schedules E, I and L were dropped, Schedules G and H were revised and Schedules X was
introduced.
1988 : Schedule M incorporating GMP (Good Manufacturing Practices) was amended and Schedule
Y Pertaining to clinical trials of newer drug formulations was incorporated.
2000 : Schedules T of Ayurvedic Siddha and Unani medicines was introduced in 2000.
2011 : Schedule H, for curbing the misuse of antibiotics and other drugs.

DEFINITION OF IMPORTANT TERMS

DRUG: [SECTION 3 (B)]

 All medicine for internal or external use of human beings or animals and all substance intended
to be used for diagnosis, treatment, mitigation, or prevention of any disease or disorder in
human being or animal including preparation applied on human body for the purpose of
repelling insect like Mosquito.
Example:
Water for injection
Empty Gelatin Capsule I.V. Solution
Mosquito repellent
Sanitary pad
EXAMPLE
Blood- when used for Boroline
treatment of disease
Absorbent cotton wool
Gudakhu Distilled water Bandages

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 GPAT DISCUSSION CENTER
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COSMETIC: [SECTION 3 (A)]

It means any article intended to be rubbed, sprayed, poured, sprinkled on or introduced into or
otherwise applied to the human body thereof, for cleansing, beautifying or promoting the
attractiveness or altering the appearance and also includes any article intended to be used as a
component of cosmetic but does not include soap.
Cream

Powder EXAMPLE Nail polish

Tooth paste

OVER-THE-COUNTER (OTC)

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a prescription
from a healthcare professional, as opposed to prescription drugs, which may be sold only to
consumers possessing a valid prescription.
Acetaminophen (Tylenol)

Dextromethorphan Ibuprofen
(Robitussin) EXAMPLE (Advil, Motrin)

loratadine (Claritin 24H) Vicks

MISBRANDED DRUGS ADULTERATED DRUGS SPURIOUS DRUGS

 If it is not labeled in the  If it is consist in whole or in  If it is imported (manufactured
prescribed manner part, of any filthy, putrid, of in relation to manufacture, sale
 If it is so coloured, coated, decomposed substance and distribution of drugs)
powdered or polished that  If it has been prepared under a name which belong to
damage is concealed or if packed or stored under another drugs
it is made appear of better insanitary conditions  If it has been substituted
or greater therapeutic whereby have been render wholly or in part by another
value than it's really. injurious to health. drugs or substance
 If it is label or container  If its container is composed,  If it purports to be the product
or anything accompanying in whole or in part of any of a manufacture of whom it is
the drug bears any poisonous substance to not truly a product.
statement, design or device health.
which make any false claim  If it contain harmful or
for the drug or which is toxic substance injurious
false or misleading in any to health.
particular.  Any substance mixed which
reduce the quality.

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