Pharmaceutical jurisprudence Thakur Prakashan Book

Pharmaceutical jurisprudence Thakur Prakashan Book

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Pharmaceutical jurisprudence Thakur Prakashan Book
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




           Books are Available for Online Purchase at: tppl.org.in




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Pharmaceutical Jurisprudence
Edition 2019

Copyright © All Rights Reserved
This book is sole subject to the condition that it shall not, by way of trade or otherwise, be lent, resold,
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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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                                              -8-


                                      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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                                              -9-

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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                                            - 10 -

         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.
*
           Exercise                                                                  *
                                                                                           143
                                              - 11 -

           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




*                                                                          *
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.
*                                                                                     *
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 
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