PHARMACEUTICAL
JURISPRUDENCE
B.Pharm, Semester-V
According to the syllabus based on ‘Pharmacy Council of India’
Dr. Rajat Kumar Kar
M.Pharm, Ph.D
Principal,
Dadhichi College of Pharmacy, Cuttack, Odisha
Dr. T. Purushoth Prabhu
M.Pharm, Ph.D
Professor & Head, Department of Pharmacy,
C. L. Baid Metha College of Pharmacy, Chennai
Dr. Kunal N. Patel
M.Pharm, Ph.D
Associate Professor,
Shree Swaminarayan Sanskar Pharmacy College, Gandhinagar, Gujarat
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Pharmaceutical Jurisprudence
Edition 2019
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“I dedicate this book
to
my beloved father, Late Sri Durgaram Kar
&
my loving mother, Smt. Anita Kar”
-Dr. Rajat Kumar Kar
“Dedicated
to
Almighty God, my Parents
&
Family Member”
- Dr. T. Purushoth Prabhu
“Dedicated
to
God, Teachers
&
Family Members”
-Dr. Kunal N. Patel
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Preface
It is with great pleas ure that we introduce the book “ Pharmaceutical
Jurisprudence”. The book allows for the lucid understanding of different
fundamentals of physical chemistry . This book is a genuine effort to clarify the
basics of Pharmaceutical Jurisprudence in an effortless and interesting manner
and as per the syllabus prescribed for the B.Pharm Sem ester V students by
Pharmacy Council of India.
All efforts have been made to keep the text error -free and to present the subject
in a student friendly and easy to understand. However, any suggestions and
constructive comments would be highly appreciated and incorporat ed in the
future edition.
Learning Outcomes Related to Knowledge and Cognitive Skills:
At the end of the course student will be able to:
1) Understand various fundamentals of the Drugs and Cosmetics Act.
2) Know about the details of various Schedules under the Drugs and Cosmetics
Act.
3) Understand the fundamentals of the Pharmacy Act, Medicinal and Toilet
Preparations Act, Drugs and Magic Remedies Act, Prevention of Cruelty to
Animals Act, etc.
4) Know about the Pharmaceutical Legislations, Code of Pharmaceutical Ethics,
RTI Act, and IPR.
Please e-mail us at, [email protected]
Website, www.tppl.org.in
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Acknowledgement
First of all, I express my sincere gratitude to Almighty, for giving me enough
strength for accomplishment of the book.
I am gre atly indebted to Prof. P. Ellaiah , former Professor, Andhra University
for his constant encouragement for this kind of academic activity. I am too
delighted to express my gratitude to Prof. B. B. Barik , Principal, Bharat
Technology, Uluberia, Howrah, West Bengal, India, for his inspiration to that
venture.
I am thankful to Dr. S. K. Mohapatra, Dean Pharmacy, BPUT, Rourkela,
Odisha, Dr. S. Mohapatra Assistant Professor SPS, S’O’A Deemed to be
University, Mr. P. K. Biswal, Associate Professor , Dadhichi Coll ege of
Pharmacy, for their outstanding support for the successful completion of this
book.
My special thanks to Dr. Manoj Kumar Dash , Chairman, Dadhichi Group of
Institutions for his constant support and encouragement.
Finally, I would like to acknowledg e with gratitude to Dr. S. R. Mishra ,
Director, Jeypore College of Pharmacy, Dr. A. K. Mishra , Principal, College of
Pharmaceutical Science, Puri and my Family, Friends, Relatives, for their
support for this undertaking.
I also express my thanks to Thakur Publication Pvt. Ltd to bring this edition.
-Dr. Rajat Kumar Kar
I acknowledge my Professors, Teachers and Students, who helped me to
understand about pharmacy profession and subject in great depth.
I take th is opportunity to thank Thakur Publication Pvt. Ltd , especially
Ms. Tuhina Banerjee (Copy Editor) & Ms. Sana (Sr. Marketing Coordinator),
for considering me author of this book.
- Dr. T. Purushotha Prabhu
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Writing a book is harder than I thought and more rewarding than I could have
ever imagined. None of this would have been possible without the strength given
by God.
To write a book of this magnitude, it needs lot of patience, skill and expertise
over the subject, which I have gained because of the opportunity given to me by
Dr. M. M. Pat el, Director, Shree Swaminarayan Sanskar Pharmacy College,
Zundal, Gandhinagar, Gujarat and Ex Vice -Chancellor, HNGU, Patan, Gujarat.
I am heartily thankful for his valuable comments, suggestions and meticulous
attention in bringing out this book.
I would like to express my deep sense and profound gratitude to Param Pujya
Shastri Swami Shri Purushottam Charandasji , Managing Trustee, Shree
Swaminarayan Sanskar Deep Trust, Zundal for providing me constant
encouragement during completion of this book.
I would like to express gratitude towards Dr. B. N. Suhagia Sir , Dean, Faculty
of Pharmacy, Dharamsinh Desai University, Nadiad , for his valuable guidance
and direction which helped me all the while during writing this book.
I gratefully acknowledge my Staff Co lleagues, Friends and Students, who
provided excellent and selfless support to complete this work successfully.
I would like to thank my Parents, Wife and Daughters, who supported me in
spite of all the time which took me away from them. It was a long and difficult
journey for them.
Last but not the least, I would like to thank Thakur Publication Pvt. Ltd. , for
giving me this opportunity to publish this book.
-Dr. Kunal N. Patel
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-7-
Syllabus
BP405TT: PHARMACEUTICAL JURISPRUDENCE
Sr. Topics %
No. Weightage
1. Drugs and Cosmetics Act, 1940 and its rules 1945:
Objectives, Definitions, Legal Definitions of Schedules to the Act and Rules
Import of Drugs: Classes of Drugs and Cosmetics Prohibited from Import, Import
under License or Permit. Offences and Penalties. Manufacture of Drugs:
Prohibition of Manufacture and sale of Certain Drugs , Conditions for grant of 10
License and Conditions of License for Manufacture of Drugs, MANUFACTURE
of Drugs for Test, Examination and Analysis, Manufacture of new Drug, Loan
License and Repacking License.
2. Drugs and Cosmetics Act, 1940 and its rules 1945.
Detailed study of Schedule G,H,M,N,P,T,U,V,X,Y,Part XII B, Sch F & DMR
(OA). Sale of Drugs – Wholesale, Retail sale and Restricted License. Offences and
Penalties. Labeling & Packing of Drugs – General Labeling Requirements and
Specimen Labels for Drugs and Cosmetics, List of Permitted Colors. Offences and 10
Penalties. Administration of the Act and Rules – Drugs Technical Advisory Board,
Central drugs . Laboratory, Drugs Consultative Committee, Government drug
analysts, Licensing Authorities, Controlling Authorities, Drugs Inspector.
3. Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its
constitution and functions, Education Regulations, State and Joint state
pharmacy councils; constitution and functions, Registration of Pharmacists,
Offences and Penalties.
Medicinal and Toilet Preparation Act –1955: Objectives, Definitions,
Licensing, Manufacture In bond and Outside bond, Export of alcoholic
preparations, Manufacture of Ayurvedic, Homeopathic, Patent & Proprietary
Preparations. Offences and Penalties. 10
Narcotic Drugs and Psychotropic Substances Act-1985 and Rules:
Objectives, Definitions, Authorities and Officers, Constitution and Functions of
narcotic & Psychotropic Consultative Committee, National Fund for
Controlling the Drug Abuse, Prohibition, Control and Regulation, opium poppy
cultivation and production of poppy straw, m anufacture, sale and export of
opium, Offences and Penalties.
4. Study of Salient Features of Drugs and Magic Remedies Act and its Rules:
Objectives, Definitions, Prohibition of certain advertisements, Classes of
Exempted advertisements, Offences and Penalties
Prevention of Cruelty to Animals Act-1960: Objectives, Definitions,
Institutional Animal Ethics Committee, CPCSEA guidelines for Breeding and
Stocking of Animals, Performance of Experiments, Transfer and acquisition of
animals for experiment, R ecords, Power to suspend or revoke registration, 8
Offences and Penalties
National Pharmaceutical Pricing Authority: Drugs Price Control Order
(DPCO) – 2013. Objectives, Definitions, Sale prices of bulk drugs, Retail price
of formulations, Retail price and ceiling price of scheduled formulations,
National List of EssentialMedicines (NLEM
5. Pharmaceutical Legislations : A brief review, Introduction, Study of drugs
enquiry committee, Health survey and development committee, Hathi
committee and Mudaliar committee.
Code of Pharmaceutical Ethics Definition, Pharmacist in relation to his job,
trade, medical profession and his profession, Pharmacist’s oath. 7
Medical Termination of Pregnancy Act.
Right to Information Act.
Introduction to Intellectual Property Rights (IPR).
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Contents
Chapter-1: Drugs and Cosmetics Act -I
1.1. Drugs And Cosmetics Act, 1940 And Its Rules 13
1.1.1. Introduction 13
1.1.2. Definitions 14
1.1.3. Objectives 16
1.1.4. Legal Definitions of Schedules To The Act 16
1.1.5. Legal Definitions of Schedules To Rules 16
1.1.6. Import of Drugs 18
1.1.6.1. Classes of Drugs and Cosmetics Prohibited from Import 18
1.1.6.2. Import under License or Permit 19
1.1.6.3. Conditions of Import License 20
1.1.6.4. Import of Drugs for Examination, Test, or Analysis 20
1.1.6.5. Import of Drugs for Personal Use 21
1.1.6.6. Import of New Drugs 21
1.1.6.7. Procedure for Import of Drugs 21
1.1.6.8. Exempted Drugs 22
1.1.6.9. Offences and Penalties 23
1.1.7. Manufacture of Drugs 24
1.1.7.1. Prohibition of Manufacture and Sale of Certain Drugs 24
1.1.7.2. Kinds of License and Conditions for Grant of License 25
1.1.7.3. Loan License 26
1.1.7.4. Repacking License 26
1.1.7.5. Licence to Manufacture of Biological and other Special Products Specified in 27
Schedules C and C1
1.1.7.6. Licence to Manufacture of Drugs Specified in Schedule X 30
1.1.7.7. Licence to Manufacture of Drugs other than those Specified in Schedules C and 31
C1 and Schedule X
1.1.7.8. Manufacture of Drugs for Test, Examination, and Analysis 32
1.1.7.9. Manufacture of New Drugs 33
1.1.7.10. Offences and Penalties 33
1.2. Summary 34
1.3. Exercise 35
Chapter-2: Drugs and Cosmetics Act and Rules-II
2.1. Detailed Study of Schedules 36
2.1.1. Introduction 36
2.1.2. Schedule G 36
2.1.3. Schedule H 36
2.1.4. Schedule M 37
2.1.5. Schedule N 41
2.1.6. Schedule P 42
2.1.7. Schedule T 43
2.1.8. Schedule U 45
2.1.9. Schedule V 48
2.1.10. Schedule X 49
2.1.11. Schedule Y 49
2.1.12. Schedule F - Part XII B 51
2.1.13. DMR (OA) 57
2.1.14. Sale of Drugs 58
2.1.14.1. Wholesale of Drugs 58
2.1.14.2. Retail Sale of Drugs 60
2.1.14.3. Restricted Licences 61
2.1.14.4. Procedure for the Sale, Purchase, and Storage of Drugs 62
2.1.14.5. Classes of Drugs whose Sale is Prohibited 64
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2.1.14.6. Offences and Penalties 65
2.1.15. Labelling and Packing of Drugs 66
2.1.15.1. General Labelling Requirements 66
2.1.15.2. Specimen Labels for Drugs And Cosmetics 68
2.1.15.3. List of Permitted Colours 70
2.1.15.4. Offences And Penalties 71
2.1.16. Administration of the Act and Rules 71
2.1.16.1. Drugs Technical Advisory Board (DTAB) 72
2.1.16.2. Central Drugs Laboratory 73
2.1.16.3. Drugs Consultative Committee 73
2.1.16.4. Government Drug Analysts 73
2.1.16.5. Licensing Authorities 75
2.1.16.6. Controlling Authorities 75
2.1.16.7. Drug Inspectors 75
2.2. Summary 78
2.3. Exercise 79
Chapter-3: Pharmacy Act, 1948
3.1. Pharmacy Act - 1948 81
3.1.1. Introduction 81
3.1.2. Definitions 81
3.1.3. Objectives 82
3.1.4. Pharmacy Council of India 82
3.1.4.1. Constitution 83
3.1.4.2. Functions 84
3.1.5. Education Regulations 86
3.1.5.1. Applications of Education Regulations to States 87
3.1.5.2. Approval of Study Courses and Examinations 87
3.1.5.3. Withdrawal of Approval 88
3.1.5.4. Approval of Other Qualifications 89
3.1.5.5. The Central Register of Pharmacists 89
3.1.6. State and Joint State Pharmacy Council 90
3.1.6.1. Constitution 90
3.1.6.2. Functions 92
3.1.7. Registration of Pharmacists 94
3.1.8. Offences and Penalties 96
3.2. Summary 97
3.3. Exercise 98
Chapter-4: Medicinal and Toilet Preparations Act,
1955
4.1. Medicinal And Toilet Preparation Act-1955 99
4.1.1. Introduction 99
4.1.2. Definitions 99
4.1.3. Objectives 100
4.1.4. Licensing 100
4.1.5. Manufacture In Bond and Outside Bond 101
4.1.5.1. Manufacture In Bond (Bonded Laboratory) 101
4.1.5.2. Manufacture Outside Bond (Non-Bonded Laboratory) 105
4.1.6. Export of Alcoholic Preparations 107
4.1.7. Procedures 109
4.1.8. Manufacture of Ayurvedic, Homeopathic, Patent and Proprietary Preparations. 111
4.1.9. Offences and Penalties 112
4.2. Summary 113
4.3. Exercise 114
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Chapter-5: Narcotic Drugs and Psychotropic
Substances Act and Rules
5.1. Narcotic Drugs And Psychotropic Substances Act-1985 And Rules 115
5.1.1. Introduction 115
5.1.2. Objectives 115
5.1.3. Definitions 116
5.1.4. Authorities and Officers 119
5.1.4.1. Measures by Central Government for Preventing Abuse of and Illicit Traffic in 119
Narcotic Drugs, etc.
5.1.4.2. Officers of Central Government 119
5.1.4.3. Constitution and Functions of Narcotic and Psychotropic Consultative 120
Committee
5.1.4.4. National Fund for Controlling the Drug Abuse 120
5.1.5. Prohibition, Control and Regulation 121
5.1.6. Opium Poppy Cultivation and Production of Poppy Straw 123
5.1.7. Manufacture of Opium 125
5.1.8. Sale and Export of Opium 128
5.1.9. Offences and Penalties 129
5.2. Summary 130
5.3. Exercise 131
Chapter-6: Drugs and Magic Remedies Act and
Rules
6.1. Sailent Features of Drugs and Magic Remedies Act and Its Rules 132
6.1.1. Introduction 132
6.1.2. Objectives 132
6.1.3. Definitions 132
6.1.4. Prohibition of Certain Advertisements 133
6.1.5. Classes of Exempted Advertisements 133
6.1.6. Powers of Entry, Search, and Seizure 134
6.1.7. Exemptions 134
6.1.8. Offences and Penalties 135
6.2. Summary 135
6.3. Exercise 136
Chapter-7: Prevention of Cruelty to Animals Act
7.1. Prevention of Cruelty to Animals Act-1960 137
7.1.1. Introduction 137
7.1.2. Objectives 137
7.1.3. Definitions 137
7.1.4. Institutional Animal Ethics Committee (IAEC) 138
7.1.5. CPCSEA Guidelines for Breeding and Stocking of Animals 138
7.1.6. Performance of Experiments 139
7.1.6.1. Committee for Control and Supervision of Experiments on Animals 139
7.1.6.2. Sub-Committee 139
7.1.6.3. Staff of the Committee 139
7.1.6.4. Duties of the Committee and Power of the Committee to Make Rules Relating 139
to Experiments on Animals
7.1.6.5. Power of Entry and Inspection 140
7.1.6.6. Power to Prohibit Experiments on Animals 141
7.1.7. Transfer and Acquisition of Animals for Experiment 141
7.1.8. Records 141
7.1.9. Power to Suspend or Revoke Registration 141
7.1.10. Offences and Penalties 142
7.2. Summary 142
7.3.
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Exercise *
143
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Chapter-8: National Pharmaceutical Pricing
Authority
8.1. National Pharmaceutical Pricing Authority 144
8.1.1. Introduction 144
8.1.2. Drug Price Control Order (DPCO)-2013 144
8.1.3. Objectives 144
8.1.4. Definitions 145
8.1.5. Sale Prices of Bulk Drugs 147
8.1.6. Price of Formulations 148
8.1.6.1. Retail Price of Scheduled Formulations 148
8.1.6.2. Ceiling Price of Scheduled Formulations 149
8.1.7. National List of Essential Medicines (NLEM) 149
8.2. Summary 150
8.3. Exercise 151
Chapter-9: Pharmaceutical Legislations
9.1. Pharmaceutical Legislations 152
9.1.1. Introduction 152
9.1.2. Origin 152
9.1.3. Scope and Objectives 153
9.1.4. Study of Drugs Enquiry Committee 155
9.1.5. Health Survey and Development Committee 156
9.1.6. Hathi Committee 157
9.1.7. Mudaliar Committee 158
9.2. Summary 159
9.3. Exercise 160
Chapter-10: Code of Pharmaceutical Ethics
10.1. Code of Pharmaceutical Ethics 161
10.1.1. Introduction and Definition 161
10.1.2. Principles 161
10.1.3. Pharmacist in Relation to His Job 162
10.1.4. Pharmacist in Relation to His Trade 164
10.1.5. Pharmacist in Relation to His Medical Profession 165
10.1.6. Pharmacist in Relation to His Profession 165
10.1.7. Pharmacist’s Oath 166
10.2. Summary 166
10.3. Exercise 167
Chapter-11: Medical Termination of Pregnancy Act
11.1. Medical Termination of Pregnancy Act 168
11.1.1. Introduction 168
11.1.2. Definitions 168
11.1.3. Termination of Pregnancies 168
11.1.4. Experience or Training 170
11.1.5. Approval of a Place 170
11.1.6. Admission Register 171
11.1.7. Custody of Forms 171
11.1.8. Power to Make Rules 172
11.1.9. Power to Make Regulations 172
11.1.10. Offences and Penalties 172
11.2. Summary 173
11.3. Exercise 173
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- 12 -
Chapter-12: Right to Information Act
12.1. Right To Information (RTI) Act 175
12.1.1. Introduction 175
12.1.2. Salient Features 175
12.1.3. Objective 176
12.1.4. Definitions 176
12.1.5. Right to Information 177
12.1.6. Obligation of Public Authorities 177
12.1.7. Suo Motu Disclosure 178
12.1.8. Exemption from Disclosure of Information 179
12.1.9. Central and State Information Commission 179
12.1.9.1. Constitution of the Central and State Information Commission 180
12.1.9.2. Powers and Functions of Information Commission 180
12.1.10. Jurisdiction of Courts 181
12.2. Summary 181
12.3. Exercise 181
Chapter-13: Intellectual Property Rights
13.1. Intellectual Property Rights (IPRs) 183
13.1.1. Introduction 183
13.1.2. Legislations Regulating Intellectual Property in India 183
13.1.3. Forms of IPRs 184
13.1.4. Patents 184
13.1.4.1. Conditions of Patentability 184
13.1.4.2. Applying for Patent Right 185
13.1.4.3. Rights of a Patentee 185
13.1.4.4. Importance of Patents 186
13.1.5. Trademarks 187
13.1.5.1. Features of Trademarks 187
13.1.5.2. Types of Trademarks 188
13.1.5.3. Procedure for Registration of Trademark 189
13.1.5.4. Importance of Trademarks 190
13.1.6. Copyrights 191
13.1.6.1. Types of Work Covered under Copyright 191
13.1.6.2. Rights Conferred by Copyright 192
13.1.6.3. Registration of Copyright 193
13.1.6.4. Importance of Copyright 193
13.1.7. Trade Secrets 194
13.1.7.1. Features of Trade Secrets 194
13.1.7.2. Tools to Protect Trade Secrets 195
13.1.7.3. Importance of Trade Secrets 195
13.1.8. Licensing 196
13.1.8.1. Types of Licensing 196
13.1.8.2. Advantages of Licensing 197
13.1.8.3. Disadvantages of Licensing 198
13.1.9. Franchising 199
13.1.9.1. Features of Franchising 199
13.1.9.1. Types of Franchising 200
13.1.9.2. Advantages of Franchising 200
13.1.9.3. Disadvantages of Franchising 202
13.2. Summary 203
13.3. Exercise 204
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Drugs and Cosmetics Act -I (Chapter 1) 13
CHAPTER Drugs and Cosmetics
1 Act -I
1.1. DRUGS AND COSMETICS ACT,
1940 AND ITS RULES
1.1.1. Introduction
The main aim of The Drugs and Cosmetics Act, 1940 and Rules 1945 is to
maintain the import, manu facture, distribution, and sale of drug s and
cosmetics. Continuous use of cosmetics in luxury items prove to be harmful
as they may contain harmful ingredients. Therefore, there is a need to control
the cosmetics.
This Act verifies that the drugs and cosmetics should be manufactured,
distributed, and sold only by qualified persons having a license for this purpose.
The Central and State Drugs Control authorities are also recognised to control
these actions.
To this Act and Rules, timely amendments are made. The major amendment was
made in 1982, in which Schedules E, I, and L were eliminated, Schedules G and
H were revised and expanded, and Schedule X was added.
Previously there were Schedule C and C 1 drugs, and drugs other than those
specified in these schedules. At the present time, there are:
1) Drugs not specified in Schedule C, C1, and X,
2) Schedule C and C1 drugs, excluding Schedule X drugs, and
3) Schedule X drugs.
Schedules M and Y were established in 1988. In relation to Jammu and Kashmir,
the chapter related to import of drugs and cosmeti cs should take effect from the
date after the commencement of the Drugs and Cosmetics (Amendment) Act,
1972, the Central Government may appoint in this behalf by notifying the
Official Gazette.
The main concern of this Act is to verify the standards and q uality of drugs
manufactured in India and to regulate their manufacture, sale, and distri bution.
Excise duties and imposition of narcotic drugs are not the part of this Act.
This Act aims to maintain high standards of medical treatment by avoiding sub -
standard in drugs when the required concomitant of medical or surgical treatment
is allowed to be diluted.
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14 Pharmaceutical Jurisprudence
1.1.2. Definitions
1) Drug includes:
i) All medicines for internal or external use of human beings or animals
and all substances intended to be used for or in t he diagnosis, treatment,
mitigation or prevention of any disease or disorder in human beings or
animals, including preparations applied on human body for the purpose
of repelling insects like mosquitoes;
ii) Such substances (other than food) intended to affect the structure or any
function of the human body or intended to be used for the destruction of
vermin or insects which cause disease in human beings or animals, as
may be specified from time to time by the Central Government by
notification in the Official Gazette;
iii) All substances intended for use as components of a drug including empty
gelatine capsules; and
iv) Such devices intended for internal or external use in the diagnosis,
treatment, mitigation or prevention of disease or disorder in human
beings or ani mals, as may be specified from time to time by the Central
Government by notification in the Official Gazette, after consultation
with the Drugs Technical Advisory Board (DTAB).
2) Patent or proprietary medicine refers to a remedy whose formula is owned
exclusively by the manufacturer and which is marketed usually under a name
registered as a trademark:
i) In relation to Ayurvedic, Siddha, Unani, or Tibb systems of medicine all
formulations containing only such ingredients mentioned in the formulae
described in the authoritative books of Ayurvedic, Sidha, Unani or Tibb
systems of medicine specified in the First Schedule, but does not include
a medicine which is administered by parenteral route and also a
formulation included in the authoritative books as specifi ed in the First
Schedule;
ii) In relation to any other systems of medicine, a drug which is a remedy or
prescription presented in a form ready for internal or external
administration of human beings or animals and which is not included in
the edition of the In dian Pharmacopoeia for the time being or any other
Pharmacopoeia authorized in this behalf by the Central Government after
consultation with the DTAB.
3) Misbranded drug is deemed to be misbranded:
i) If it is so coloured, coated, powdered or polished that damag e is
concealed or if it is made to appear of better or greater therapeutic value
than it really is; or
ii) If it is not labelled in the prescribed manner; or
iii) If its label or container or anything accompanying the drugs bears any
statement, design or device whi ch makes any false claim for the drug or
*
which is false or misleading in any particular. *
Drugs and Cosmetics Act -I (Chapter 1) 15
Misbranding should, as well, be such as cannot be detected by a lay
purchaser with the ordinary diligence. A phonetic similarity in two
trademarks like ‘Cocogem’ and ‘Kotogem’ is not sufficient. There should be
reasonable probability of deception.
4) Adulterated drug is deemed to be adulterated:
i) If it consists, in whole or in part, of any filthy, putrid or decomposed
substance; or
ii) If it has been prepared, packed or stored under insanitary conditions
whereby it may have been rendered injurious to health; or
iii) If its container is composed, in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to health; or
iv) If it bears or contain s for purposes of colouring only, a colour other than
one which is prescribed; or
v) If it contains any harmful or toxic substance which may render it
injurious to health; or
vi) If any substance has been mixed therewith so as to reduce its quality or
strength.
5) Spurious drug is deemed to be spurious:
i) If it is imported (manufactured in relation to manufacture, sale and
distribution of drugs) under a name which belongs to another drug; or
ii) If it is an imitation of or is a substitute for, another drug or resembles
another drug in a manner likely to deceive or bears upon it or upon its
label or container the name of another drug unless it is plainly and
conspicuously marked so as to reveal its true charac ter and its lack of
identity with such other drugs; or
iii) If the lab el or container bears the name of an individual or com pany
purporting to be the manufacturer of the drug, which individual or
company is fictitious or does not exist; or
iv) If it has been substituted wholly or in part by another drug or
substance; or
v) If it purports to be the product of a manufacturer of whom it is not truly a
product.
Where cartons containing drugs were sold as received from company and the
accused was ignorant about the spurious contents, he is fully protected by
clause (3) of Section 19 of the Act.
6) Misbranded cosmetics is deemed to be misbranded:
i) If it contains a colour which is not prescribed; or
ii) If it is not labelled in the prescribed manner; or
iii) If the label or container or anything accompanying the cosmetic bears
any statement which is false or misleading in any particular.
7) Spurious cosmetic is deemed to be spurious:
i) If it is imported under a name which belongs to another cosmetic; or
ii) If it is an imitation of, or is a substitute for, or resembles another
*
cosmetic in a manner likely to dec eive or bears upon it or upon its label *
16 Pharmaceutical Jurisprudence
or container the name of another cosmetic, unless it is plainly and
conspicuously marked so as to reveal its true character and its lack of
identity with such other cosmetic; or
iii) If the label or container bears the na me of an individual or a company
purporting to be the manufacturer of the cosmetic, which individual or
company is fictitious or does not exist; or
iv) If it purports to be the product of a manufacturer of whom it is not truly a
product.
1.1.3. Objectives
Following are the objectives of this Act:
1) For preventing substandard i n drugs, probably for treatment and preserving
high medical standards.
2) For controlling the import, manufacture, distribution , and sale of drugs and
cosmetics by licensing.
3) For ensuring that m anufacture, distribution, and sale of drugs and cosmetics
is done by qualified persons only.
4) For controlling the manufacture and sale of Pharmaceutical jurisprudence Thakur Prakashan Book
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