A Text Book of

PHARMACEUTICAL
JURISPRUDENCE
As Per PCI Regulations
THIRD YEAR B. PHARM.
SEMESTER V

Sandeep D.S. Dr. R. Narayana Charyulu

M. Pharm. M. Pharm., Ph.D.
Assistant Professor, Professor and Head,
Department of Pharmaceutics, Department of Pharmaceutics,
NGSM Institute of Pharmaceutical Sciences, NGSM Institute of Pharmaceutical Sciences,
Nitte (Deemed to be University), Nitte (Deemed to be University),
Mangalore. Mangalore.

Shabana S.
M. Pharm
Assistant Professor,
Department of Pharmacognosy,
East West College of Pharmacy,
Bengaluru 91.

N3999
Pharmaceutical Jurisprudence ISBN 978-81-942538-8-4
First Edition : August 2019
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Preface
Pharmaceutical Jurisprudence is the study of basic pharmaceutical laws and regulations.
It is the basic subject where pharmacy students should be informed about various acts and
legislative principles related to the profession of pharmacy in India and as well as the
pharmaceutical industry.
A Text Book of Pharmaceutical Jurisprudence is the outcome of numerous efforts of
authors to assimilate the voluminous knowledge of Jurisprudence. The present book has
compiled all the topics which were included in the new revised syllabus for Semester-V of
Third Year of the B. Pharm course implemented by Pharmacy Council of India regulations,
New Delhi.
The book is designed to have 05 units, divided into 13 parts with simple and lucid
language. The authors tried to include objectives of each topic explaining the study
outcomes once the students understand the topics. Apart from the basic topics, the two new
topics RTI Act and IPR concepts were also included with latest information and
implementations.
The authors are delighted since it is a first attempt to write this book and hope the
readers; teachers, students and the people working in pharmaceutical industries will be
benefitted and may get the required information from the sources of the text book.
The Authors convey the deep sense of gratitude to their family and fellow teacher
colleagues who always remained as a force behind writing this book.
The authors would like to thank the authorities of NGSM Institute of Pharmaceutical
Sciences, Nitte (Deemed to be University), Deralakatte, Mangalore and East West College of
Pharmacy, Bengaluru for positive and constant support.
The authors of NGSMIPS and EWCP would like to thank librarian Mr. Chandrasekhar
and Mr. Nagesh respectively who helped to utilize the library sources and digital library for
preparing and successful completion of this book.
The Authors would like to acknowledge their special thanks to publishers Shree Dinesh
Furia and Shree Jignesh Furia and staff of Nirali Prakashan specially Malik Shaikh,
Mrs. Manasi Pingle, Mrs. Roshan Khan, Mr. Ravindra Walodare Pune for bringing out nicely
printed book.
Any suggestions and comments for further improvements from students and teachers
are welcome and will be thankfully acknowledged.

Authors
Syllabus
UNIT - I 10 Hours
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 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.
UNIT - II 10 Hours
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 and Packing of Drugs - General Labeling Requirements and Specimen Labels for Drugs and
Cosmetics, List of Permitted Colours. Offences and 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
Inspectors.
UNIT - III 10 Hours
• 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 and Proprietary
Preparations. Offences and Penalties.
• Narcotic Drugs and Psychotropic Substances Act, 1985 and Rules: Objectives, Definitions, Authorities and
Officers, Constitution and Functions of Narcotic and Psychotropic Consultative Committee, National Fund for
Controlling the Drug Abuse, Prohibition, Control and Regulation, Opium Poppy Cultivation and Production of
Poppy Straw, Manufacture, Sale and Export of Opium, Offences and Penalties.
UNIT - IV 08 Hours
• 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, Records, Power to Suspend or Revoke Registration, 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 Essential Medicines (NLEM).
UNIT - V 07 Hours
• 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.
• Medical Termination of Pregnancy Act.
• Right to Information Act.
• Introduction to Intellectual Property Rights (IPR).
✱✱✱
Contents
Unit I

1. The Drugs and Cosmetics Act, 1940 and Its Rules, 1945 1.1 - 1.18
1.1 Introduction 1.1
1.2 Objectives 1.1
1.3 Definitions 1.2
1.4 Schedules to the Act and Rules 1.5
1.4.1 Schedules to the Act 1.5
1.4.2 Schedules to the Rules 1.5
1.5 Import of Drugs 1.7
1.6 Manufacture of Drugs 1.11
1.6.1 Prohibition of Manufacture and Sale of Certain Drugs 1.11
1.6.2 Conditions for Grant of License 1.12
1.6.3 Types of Licenses for Manufacture of Drugs 1.12
1.6.4 Conditions of License for Manufacture of Drugs 1.13
1.7 Loan License 1.16
1.8 Repacking License 1.17
• Exercise 1.17
• Bibliography 1.18
Unit II

2. Drugs and Cosmetics Act, 1940, and Its Rules 1945 2.1 - 2.30
2.1 Detailed Study of the Schedules 2.1
2.2 Sale of Drugs 2.17
2.2.1 Wholesale, Retail and Restricted Sale Licenses 2.17
2.2.2 Offences and Penalties 2.20
2.3 Labelling and Packing of Drugs and Cosmetics 2.20
2.3.1 General Labelling Requirements 2.20
2.3.2 Special Labelling Requirements 2.21
2.3.3 Specimen Labels 2.22
2.4 List of Permitted Colours 2.24
2.5 Offences and Penalties 2.24
2.6 Administration of the Act and Rules 2.24
2.6.1 The Drugs Technical Advisory Board (DTAB) 2.24
2.6.2 The Central Drugs Laboratory (CDL) 2.25
2.6.3 The Drugs Consultative Committee (DCC) 2.26
2.6.4 Government Drug Analysts 2.26
2.7 Licensing Authorities 2.27
2.8 Controlling Authorities 2.27
2.9 Drug Inspectors 2.28
• Exercise 2.29
• Bibliography 2.30
 Unit III
3. Pharmacy Act, 1948 3.1 - 3.10
3.1 Introduction 3.1
3.2 Objectives of the Act 3.1
3.3 Definitions 3.1
3.4 Constitution of Pharmacy Council of India 3.2
3.4.1 Functions of Pharmacy Council of India 3.3
3.4.2 Education Regulations for Pharmacy 3.3
3.5 State and Joint State Pharmacy Councils 3.5
3.5.1 Functions of State Pharmacy Councils and Joint State Pharmacy Councils 3.6
3.5.2 Offences and Penalties 3.9
• Exercise 3.10
• Bibliography 3.10

4. Medicinal and Toilet Preparations (Excise Duties) Act, 1955 4.1 - 4.12
4.1 Introduction 4.1
4.2 Objectives of the Act 4.1
4.3 Definitions 4.2
4.4 Licensing Procedure 4.3
4.5 Manufacture 4.4
4.5.1 Manufacture in Bond 4.4
4.5.2 Manufacture Outside Bond 4.7
4.6 Export of Alcoholic Preparations 4.8
4.7 Manufacture of Ayurvedic, Homeopathic and Patent and
Proprietary Preparations 4.10
4.7.1 Ayurvedic Preparations 4.10
4.7.2 Homeopathic Preparations 4.10
4.8 Offences and Penalties 4.11
• Exercise 4.12
• Bibliography 4.12

5. Narcotic Drugs and Psychotropic Substances Act, 1985 and Rules 5.1 - 5.10
5.1 Introduction 5.1
5.2 Objectives of the NDPS Act 5.2
5.3 Definitions of the Act 5.2
5.4 Authorities and Officers 5.4
5.5 Narcotic Drugs and Psychotropic Substances Consultative Committee 5.5
5.6 National Fund for Control of Drug Abuse 5.5
5.7 Prohibition, Control and Regulation 5.6
5.8 Cultivation of Opium Poppy and Production of Opium or Poppy Straw Cultivation5.7
5.9 Manufacture, Sale, and Export of Opium 5.8
5.9.1 Manufacture of Opium 5.8
5.9.2 Sale of Opium 5.8
5.9.3 Export of Opium 5.9
5.10 Offences and Penalties 5.9
• Exercise 5.10
• Bibliography 5.10
 UNIT IV
6. The Drugs and Magic Remedies (Objectionable Advertisements)
Act and its Rules 6.1 - 6.6
6.1 Introduction 6.1
6.2 Objectives 6.2
6.3 Definitions 6.2
6.4 Prohibited Advertisements 6.2
6.5 Exempted Advertisements 6.3
6.6 Offences and Penalties 6.4
• Exercise 6.5
• Bibliography 6.6

7. The Prevention of Cruelty to Animals Act, 1960 7.1 - 7.6

7.1 Introduction 7.1
7.2 Definitions 7.1
7.3 Institutional Animal Ethics Committee (IAEC) 7.2
7.4 Breeding and Stocking of Animals 7.3
7.5 Performance of Experiments 7.4
7.6 Transfer and Acquisition of Animals for Experiment 7.5
7.7 Records 7.5
7.8 Power to Suspend or Revoke the Registration 7.5
7.9 Offences and Penalties 7.5
• Exercise 7.6
• Bibliography 7.6

8. National Pharmaceutical Pricing Authority 8.1 - 8.12

8.1 Introduction 8.1
8.2 History of Price Control Policy 8.1
8.3 Objectives of the DPCO Act 8.2
8.4 Definitions 8.3
8.5 Sale Prices of Bulk Drugs 8.4
8.5.1 Calculation of Retail Price of Formulations 8.5
8.5.2 Pricing of the Scheduled Formulations Covered under Drugs
(Prices Control) Order, 1995 8.5
8.5.3 Ceiling Price or Retail Price of a Pack 8.6
8.6 Price of Formulations (Branded or Generic) Listed in the
NLEM Launched by a Manufacturer 8.6
8.7 National List of Essential Medicines, 2011 8.7
• Exercise 8.12
• Bibliography 8.12
UNIT V
9. Pharmaceutical Legislations in India 9.1 - 9.4
9.1 History of Pharmaceutical Legislation in India 9.1
9.2 Drugs Enquiry Committee 9.2
9.3 Health Survey and Development Committee 9.3
 9.4 Mudliar Committee 9.3
9.5 Hathi Committee 9.3
• Exercise 9.3
• Bibliography 9.4

10. Code of Pharmaceutical Ethics 10.1 - 10.6

10.1 Introduction 10.1
10.2 Pharmaceutical Code of Ethics 10.1
10.3 Pharmacist in Relation to his Trade 10.3
10.4 Pharmacist in Relation to Medical Profession 10.4
10.5 Pharmacist in Relation to his Profession 10.5
10.6 Pharmacist’s Oath 10.6
• Exercise 10.6
• Bibliography 10.6

11. Medical Termination of Pregnancy Act 11.1 - 11.4

11.1 Introduction 11.1
11.2 Definitions 11.1
11.3 Provisions of the Act 11.2
11.4 Requirement of Experience or Training for an RMP to Terminate Pregnancy 11.2
11.5 Maintenance of Records 11.3
11.6 Offences and Penalties 11.3
• Exercise 11.3
• Bibliography 11.4

12. Right to Information (RTI) Act 12.1 - 12.6

12.1 Introduction 12.1
12.2 Definitions 12.1
12.3 Right to Information and Obligations of Public Authorities 12.3
12.4 The Central Information Commission 12.4
12.5 The State Information Commission 12.4
12.6 Powers and Functions of the Information Commissions 12.5
• Exercise 12.6
• Bibliography 12.6

13. Intellectual Property Rights 13.1 - 13.8

13.1 Introduction 13.1
13.2 Patents and Patent Act 13.1
13.2.1 Indian Patent Act 13.1
13.2.2 Definitions of Indian Patent Act 13.2
13.2.3 Types of Patent 13.4
13.2.4 Procedure for Getting a Patent 13.4
13.3 Different IPR Approaches 13.5
13.4 Copyright 13.7
• Exercise 13.7
• Bibliography 13.8

✱✱✱
 UNIT I

Chapter ... 1
DRUGS AND COSMETICS ACT, 1940
AND ITS RULES 1945

♦ LEARNING OBJECTIVES ♦
After completing this chapter, the reader should be able to understand:
About the compilation of Drug and Cosmetic Acts 1940 and Rules 1945.
Regulation of import, manufacture, sale and distribution of drugs and cosmetics.
To avoid substandard drugs and to maintain high standards of drugs and cosmetics.

1.1 INTRODUCTION
The Central Legislative Assembly passed the Drugs and Cosmetics Act 1940 and rules
1945 with an objective to regulate the import, manufacture and distribution and sale of
drugs and cosmetics. It is applicable on Allopathic, Homeopathic, Unani and Siddha drugs as
well on contraceptives, mosquitoe repellents, creams, lotions, cosmetics and devices used for
internal and external use for diagnosis. Under this Act, the regulation of manufacture, sale
and distribution of Drugs is primarily the concern of the State authorities while the Central
authorities are responsible for approval of New Drugs, Clinical trials in the country, laying
down standards for Drugs, control over the quality of imported drugs, co-ordination of the
activities of Drug Control Organization and providing expert advice with a view of bringing
about uniformity in the enforcement of Drug and Cosmetic Act.
1.2 OBJECTIVES
1. The Drugs and Cosmetics Act 1940 provides the Central legislation, which regulates
import, manufacture, distribution and sale of drugs and cosmetics in the country.
2. The main objective of the Act is to ensure that the drugs available to the people are
safe and efficacious and the cosmetics marketed are safe for use.

(1.1)
Pharmaceutical Jurisprudence 1.2 Drugs and Cosmetics Act, 1940 …

3. The D and C Act regulates the manufacture and import of drugs into India so that no
substandard or spurious drugs get manufactured and imported in and into India
respectively.
4. This provides the regulation of sale and distribution of drugs and cosmetics whereby
only qualified and trained persons can undertake their handling, compounding and
distribution.
5. This Act also provides the constitution of two boards namely, the Drug Technical
Advisory Board (DTAB) and Ayurvedic and Unani Drugs Technical Advisory
Board to advise the Central and State governments on technical matters arising out
of the administration of this act.
6. It also provides the establishment of two Drugs Consultative Committees (DCC),
one for allopathic and the other for Ayurvedic, Siddha, Unani drugs to advise the
various Governments and Boards on matters tending to secure uniformity
throughout the country in the administration of the act.
1.3 DEFINITIONS
Drug:
(i) All medicines for internal or external use of human beings or animals and all
substances intended to be used for or in the 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) intend 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.
(iii) All substances intended for use as components of a drug including empty gelatin
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 animals.
Ayurvedic, Siddha or Unani Drug:
It includes all medicines intended for internal or external use of human beings or animals
for diagnosis, treatment, mitigation or prevention of disease or disorder in accordance with
the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb
system of medicine, specified in first schedule.
Misbranded Drugs:
A drug shall be deemed to be misbranded:
(i) If it is so colored, coated, powdered or polished that damage 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
Pharmaceutical Jurisprudence 1.3 Drugs and Cosmetics Act, 1940 …

(iii) If its label or container or anything accompanying the drug bears any statement,
design or device which makes any false claim for the drug or which is false or
misleading in any particular.
Adulterated Drugs:
A drug shall be 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 contaminated with filthy or 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 contains, for purposes of coloring 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.
Spurious Drugs:
A drug shall be deemed to be spurious:
(i) If it is manufactured 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 or conspicuously marked so as to reveal its true
character and its lack of identity with such other drug; or
(iii) If the label or container bears the name of an individual or company 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.
Drug Inspector:
A Drug Inspector appointed by the Central Government or a State Government who is
an expert and qualified to monitor the safety, utility, efficacy and quality of a drug from its
manufacturing till its sale at the retail shop.
Cosmetic:
Any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or
otherwise applied to, the human body or any part thereof for cleansing, beautifying,
promoting attractiveness, or altering the appearance, and includes any article intended for
use as a component of cosmetic.
Pharmaceutical Jurisprudence 1.4 Drugs and Cosmetics Act, 1940 …

Misbranded Cosmetics:
A cosmetic shall be 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.
Spurious Cosmetics:
A cosmetic shall be 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, another cosmetic or resembles another
cosmetic in a manner likely to deceive or bears upon it or upon its label 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 name 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 is an imitation of, or is a substitute for, another drug or re-not truly a product.
Drug Store:
Licensed premises for the sale of drugs, a retail store which do not require the services of
a qualified person and sells both prescription and non-prescription drugs.
Pharmacy:
Licensed premises for the sale of drugs, which require the services of a qualified person
but where the drugs are not compounded against prescriptions.
Qualified Person:
(i) He is a person holding diploma or degree in Pharmacy or Pharmaceutical Chemistry;
or
(ii) Is a registered pharmacist, (under Pharmacy Act, 1948); or
(iii) Has minimum 4 years experience of dispensing and has been approved by licensing
authority as a ‘Qualified Person’ on or before 31st Dec 1969.
Government Analyst:
A Government Analyst appointed by the Central Government or a State Government who
shall analyse or test or cause to be analysed or tested such samples of drugs as may be sent
to him by Inspectors or any other persons or authority authorised by the Central Government
or a State Government and shall furnish reports of the results of test or analysis in
accordance with these rules.
Further, shall from time to time forward to the Government reports giving the results of
analytical work and research with a view to their publication at the discretion of the
Government.
Pharmaceutical Jurisprudence 1.5 Drugs and Cosmetics Act, 1940 …

Manufacture:
In relation to any drug or cosmetic includes any process or part of a process for making,
altering, ornamenting, finishing, packing, labeling, breaking up or otherwise treating or
adopting any drug or cosmetic with a view to its sale or distribution but does not include the
compounding or dispensing of any drug, or the packing of any drug or cosmetic, in the
ordinary course of retail business.
Import:
Means to bring into India.
Patent or Proprietary Medicine:
In relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations
containing only such ingredients mentioned in the formulae described in the authoritative
books of Ayurveda, Siddha of Unani 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.
In relation to any other systems of medicine, a drug for internal or external administration
of human beings or animals and which is not included in the edition of the Indian
Pharmacopoeia or any other Pharmacopoeia or official books.
Homeopathic Medicines:
It includes any drug and whose therapeutic efficacy has been established through long
clinical experience as recorded in authoritative Homeopathic literature, prepared according
to the techniques of Homeopathic pharmacy. It does not include medicines, administered by
parenteral route.
1.4 SCHEDULES TO THE ACT AND RULES
1.4.1 Schedules to the Act
First Schedule: Names of books under Ayurvedic and Siddha systems.
Second Schedule: Standard to be compiled with by imported drugs and by drugs
manufactured for sale, stocked, or exhibited for sale or distributed.
1.4.2 Schedules to the Rules
Sr. Schedules Significance
No.
1. A Forms and formats of letters for applications of licensing etc.
2. B Fee structure for drug analysis by CDL (Central Drug Laboratory) or by
the Govt. Analyst.
3. C Biological and special products for parenteral administration.
Examples: Antibiotics, Vitamins, Bacteriophages, Surgical dressings and
Opthalmic preparations whose import, manufacture, sale and
distribution are governed by special provisions.
Pharmaceutical Jurisprudence 1.6 Drugs and Cosmetics Act, 1940 …

Sr. Schedules Significance

No.
4. C1 Other special products for non-parenteral administration. Examples:
Digitalis drugs, Ergot drugs, Adrenaline, Fish liver oil, Hormonal
preparations whose import, manufacture, sale and distribution are
governed by special provisions.
5. D Drugs exempted from the provision of import of drugs.
6. E1 Poisonous substances under Ayurvedic, Siddha and Unani system of
medicines.
7. F & F1 Special provisions applicable for the production, testing, storage,
packing and labelling of biological and other special products.
8. F2 Standards of surgical dressings.
9. F3 Standards of sterilized umbilical tapes.
10. FF Standards for ophthalmic preparations.
11. G Various drugs/ substances to be used under the medical supervision.
12. H Various drugs to be sold on the prescription of an RMP (Registered
Medical Practitioner).
13. J Various ailments (diseases) that cannot be treated by any drug
currently in market.
14. K Various substances and drugs exempted from provisions related to
manufacture of drugs.
15. M Regulations for manufacturing, premises, waste disposal, requirements
of plant and equipments (Good Manufacturing Practices).
16. M1 Requirements for factory premises, etc. for the manufacture of
Homeopathic drugs.
17. M2 Requirements for factory premises for the manufacture of cosmetics.
18. M3 Requirements for factory premises for the manufacture of medical
devices.
19. N Regulations and minimum requirements to run a pharmacy.
20. O Regulations and requirements for disinfectant fluids.
21. P Regulations regarding life period and storage of various drugs.
22. P1 Regulations regarding retail package size of various drugs.
23. Q List of permitted dyes and coal tar colours in cosmetics.
Pharmaceutical Jurisprudence 1.7 Drugs and Cosmetics Act, 1940 …

Sr. Schedules Significance

No.
24. R Standards for condoms and other mechanical contraceptives.
25. R1 Standards for medical devices.
25. S Various cosmetics and toiletries, and directs the manufacturers of
cosmetics to confirm to the latest BSI (Bureau of Indian
Standards) requirements.
26. T Regulations and requirements for factory premises and manufacture
of Ayurvedic, Siddha and Unani products.
27. U Maintenance of manufacturing and analytical records of drugs.
28. U1 Maintenance of manufacturing and analytical records of cosmetics.
29. V Standards for patent and proprietary medicines.
30. W List of drugs which can be marketed under generic names only.
31. X List of drugs which are habit forming, psychotropic and other drugs
likely to be misused for addictive purposes.
32. Y Requirement and guidelines for clinical trials.
1.5 IMPORT OF DRUGS
Prohibition of Import of Certain Drugs or Cosmetics:
Following Drugs and cosmetics cannot be imported:
1. Any drug or cosmetic which is not of standard quality;
2. Any misbranded or spurious or adulterated drug or cosmetics;
3. Any drug or cosmetic without import license, for the import, for which an import
license is prescribed.
4. Any patent or proprietary medicine, which has not displayed the true formula or list
of active ingredients with their quantities as per the label.
5. Any drug which claims to cure or prevent any disease or ailments specified in
Schedule J.
6. Any cosmetic or drug containing any ingredient, which is unsafe or harmful.
7. Any drug or cosmetic whose manufacture, sale, distribution and import of which is
prohibited by rule made under this act, except for the purpose of examination, test
or analysis.
8. Drugs not labelled in the prescribed manner.
9. Drugs after the expiry, and those which does not meet the standards, quality and
purity specified in the schedule-F.
Pharmaceutical Jurisprudence 1.8 Drugs and Cosmetics Act, 1940 …

Import of Drugs under License:

The following classes of drugs can be imported under the license or permit granted by
the licensing authority:
1. Drugs specified in schedule C and C1 excluding those specified in schedule X.
2. Drugs specified in schedule X.
3. Minor quantities of drugs imported for the examination, test or analysis.
4. Drugs for personal use covered by a prescription of RMP.
5. Any new drug.
6. An application for an import License shall be made to the licensing authority by the
manufacturer or by the manufacturer’s agent in India and shall be accompanied by a
License fee of ` 1,000 for a single drug and ` 1,000 for each additional drug, duly
signed by or on behalf of the manufacturer.
Sr. Type of Import License Form Number
No.
Application License
1. Drugs other than Schedule X 8 10
drugs
2. Schedule X drugs 8-A 10-A
7. Any application for import license in Form 8 or 8-A, shall be accompanied by a copy
of Registration Certificate issued in Form 41; in the case of emergencies, the issue of
Import License by the central government in Form 10 or 10-A without issuance of
Registration Certificate under Rule 27-A, for reasons to be recorded in writing.
8. The License remains valid upto 31st Dec of the year following the year in which its
granted unless cancelled or suspended earlier.
9. The importer should have proper storage facilities for preserving imported drugs and
properties.
10. A fee of ` 250 shall be paid for a duplicate copy of license, if the original is defaced,
damaged or lost.
Registration Certificate:
‘Registartion certificate’ means, certificate issued under Rule 27-A, by the licensing
authority in Form-41, for the registration of premises and drugs manufactured by the
manufacturer for import into and use in India.
1. A fee of ` 1,000 and US $ 500 dollars shall be paid through a Challan along with the
application in Form 40 as registration fee for his premises meant for manufacturing
of drugs intended for import and use in India.
2. A fee of US $ 300 dollars shall be paid for a duplicate copy of the Registration
Certificate, if the original is defaced, damaged.
Pharmaceutical Jurisprudence 1.9 Drugs and Cosmetics Act, 1940 …

Suspension and Cancellation:

Both the Import License and Registration Certificate will be suspended or cancelled, if the
manufacturer or licensee fails to comply with any of the conditions. The licensing authority
may after giving the manufacturer or licensee, an opportunity to show cause why such an
order should not be passed, by an order in writing the reasons and further take measures for
the same. The reasons for the cancellation may be:
1. The drugs in the schedule C and C1 are prohibited for import into the country after
the expiry of potency of the drug product.
2. If the drug is banned in the country of origin then it is prohibited from importing into
the country except for the purpose of examination, test or analysis.
Conditions of Import License:
An Import License is subject to the following conditions:
1. The licensee must observe at all the times the undertaking given by him or on his
behalf in Form 9:
2. The licensee must allow any authorized Inspector to:
(i) Enter the licensed premises where imported drugs are stored.
(ii) Inspect the substances employed for testing.
(iii) Take samples.
3. The licensee must furnish the adequate quantity of sample from the required batches
to the licensing authority for examination along with complete protocols of the test
applied.
4. If licensing authority so directs, until receipt of Certificate of Authorization, the
licensee must not sell any batch products to which samples are submitted to the
licensing authority.
5. The licensee must maintain the record of all sales of imported substances as
prescribed under the rules, and should furnish the same during the inspection.
6. The licensee must maintain separate records for the sale or distribution of Schedule-
X drugs.
7. Licensee must also comply with such further requirements, prescribed by the
authority and of which he has been given not less then four months of notice.
Import of New Drugs:
1. A written permission of the licensing authority is required for the import of new
drugs.
2. For obtaining permission, all documentary and other evidence related to the
standards of quality, purity and strength etc. should be supplied to the licensing
authority.
Pharmaceutical Jurisprudence 1.10 Drugs and Cosmetics Act, 1940 …

3. An application for an import License for small quantities of a new drug, as defined in
rule 122-E for the purpose of treatment of patient.
4. Every application in Form 12-AA shall be accompanied by a fee of one hundred
rupees for a single drug and an additional fee of fifty rupees for each additional drug.
5. The fees shall be paid through a challan in the Bank of Baroda.
6. A License for import of small quantities of a new drug, defined in rule 122-E, for the
purpose may be cancelled by the licensing authority for the conditions subject to
which the License was issued. If so, the licensee may appeal to the Central
Government within three months of the date of the order of cancellation.
Import of Drugs for Examination, Test or Analysis:
1. The drug is imported under a license in Form-11.
2. The drug must be exclusively examined in the place specified in the license by the
licensing authority.
3. An authorized inspector must be allowed to investigate the manner in which
imported substances are used; thereof allowed to take the samples.
4. The record of the imported substances along with their quantities, the date of
importation and the name of manufacturer should be maintained and reported to the
authority.
5. The licensee must comply with any further requirements as may be specified by the
authority, and of which the licensing authority has given, to him not less than notice
of a month.
6. In case if the license is cancelled, the licensee may appeal to the Central Government
within three months of the date of the order of cancellation.
Import of Drugs or Cosmetics for Personal use:
Import of drugs which are otherwise prohibited under section 10 of the act can be imported
on following conditions:
1. Drugs or cosmetics must be a part of a passenger’s bonafide baggage and must be
intended for the exclusive personal use of the passenger.
2. They must be declared to the custom collector, if so directed.
3. The quantity of any single drug so imported must not exceed hundred average
doses.
4. Any drug or cosmetic not forming the part of passenger’s baggage, may be allowed
to import to an application made to the licensing authority in form 12-A.
5. If the licensing authority is satisfied, a permit is granted in Form 12-B.
Pharmaceutical Jurisprudence 1.11 Drugs and Cosmetics Act, 1940 …

*Note: Places through which Drugs may be imported into India:

1. Ferozpur Cantonment and Amritsar Railway Stations: by rail (across the frontier with
Pakistan).
2. Ranaghat, Bangaon and Mohiassan Railway Stations: by rail (across the frontier with
Bangladesh).
3. Chennai, Calcutta, Mumbai and Cochin: by sea
4. Chennai, Calcutta, Mumbai, Delhi and Ahmedabad: by air
Offences and Penalties Relating to Import of Drugs:
Sr. Offence Penalties
No.
First conviction Subsequent
conviction
1. Import of adulterated or spurious Imprisonment upto 3 Imprisonment upto
drugs or cosmetics or any years and fine upto 5 years or fine upto
cosmetic containing any ` 5000. ` 10,000 or both.
ingredient which may render it
unsafe or harmful for the use
under directions recommended.
2. Import of drugs or cosmetics Imprisonment upto 06 Imprisonment upto
other than referred above the months or fine upto 1 year or fine upto
import of which is prohibited. ` 500 or both. ` 1000 or both.
3. Import of drugs or cosmetics in Imprisonment upto 3
contravention of any notification years or fine upto
issued under section 10-A. ` 5000 or both.
1.6 MANUFACTURE OF DRUGS
1.6.1 Prohibition of Manufacture and Sale of Certain Drugs
The following drugs are prohibited to manufacture for sale under section 18 of the act:
1. Any drug or cosmetic which is not of a standard quality or is misbranded, adulterated
or spurious;
2. Any patent or proprietary medicine, whose formula with the quantities, is not
disclosed on the lable or container;
3. Any drug which purports or claims to prevent, cure or mitigate any such disease
specified in schedule J;
4. Any cosmetic containing any ingredient which may render it unsafe or harmful for
use;
5. Any drug or cosmetic in contravention of this act or rules made thereunder;
Pharmaceutical Jurisprudence 1.12 Drugs and Cosmetics Act, 1940 …

1.6.2 Conditions for Grant of License

The license is granted, if applicant complies with the following conditions:
1. The manufacture must be conducted under active direction and personal supervision
of competent technical staff (approved manufacturing chemist), as per the rules.
2. The licensee and factory premises should comply with the conditions and
requirements prescribed under Schedule M respectively.
3. The applicant must provide for various operations, adequate space, plant and
equipment, as per Schedule M.
4. The applicant must provide separate testing unit or quality control section with an,
independent head, with adequate facilities, for the test and standardization of drugs
and raw materials.
5. The applicant should make adequate arrangements for the storage of drugs,
manufactured.
6. For patent and proprietary medicines, the applicant must furnish the documents and
data related to claims, safety, stability, therapeutic justifications etc., as per the rules.
After completion of inspection, Drug Inspector forwards detailed report and his
recommendations to the Central Licensing Authority.
1. On receipt of application in the prescribed form along with fees for grant or renewal
of license by the applicant, the authority verifies the statement, post performance of
the licensee and the above requirements. Thereafter, the Licensing authority on
necessary enquiries and satisfaction, grants the license to the applicant in the
prescribed form.
2. If Licensing authority is of the opinion that applicant is incapable to fulfill the
requirements, it may refuse to grant or renew the license.
1.6.3 Types of Licenses for Manufacture of Drugs
Sr. Classes of Drugs Form of Form of
No. Application License
1. Other than Schedule C, C1 and X 24 25
2. Schedule X 24-F 25-F
3. Schedule C and C1 27 28
4. Schedule C, C1 and X 27-B 28-B
5. Loan License (other than Schedule C, C1 and X) 24-A 25-A
6. Loan License (only Schedule C, C1) 27-A 28-A
7. Repacking License (other than Schedule C, C1 and X) 24-B 25-B
8. Large volume parenterals, sera and vaccines 27-D 28-D
Pharmaceutical Jurisprudence 1.13 Drugs and Cosmetics Act, 1940 …

1.6.4 Conditions of License for Manufacture of Drugs

Manufacture of Schedule C, C1 and X Drugs:
Following are the general conditions of license of schedule C, C1 and X drugs in
Form 28-B and 28-D; other than schedule C and C1 drugs in Form 25; Schedule X drugs-
Form 25-F.
Sr. Licensee must
No.
1. provide and maintain staff, premises and equipments (as per Schedule M and
Schedule M3 for medical devices).
2. test raw materials and final products of each batch either in the laboratory approved
by the licensing authority.
3. maintain records of manufacture and testing of each batch as per schedule U.
4. allow Drug Inspector to enter and inspect, premises, plant, process of manufacture,
means of standardization and tests.
5. allow Drug Inspector to inspect all the registers and records maintained under the
rules and to take samples of manufactured drugs.
6. provide the required information to Drug Inspector for ascertaining compliance for
provisions of Act and Rules.
7. time to time report to the licensing authority:
(i) Changes in expert staff responsible for manufacture or testing.
(ii) Material alterations in premises or plant.
(iii) samples of desired drugs and complete protocols of tests applied.
8. not sell any batch, sample of which is submitted to the licensing authority, until
receipt of Certificate of authorization is issued.
9. withdraw from sale remainder of any batch or recall drugs already issued, if licensing
authority directs to do so.
10. not sell any drug manufactured under the license unless due precautions, necessary
for preserving its properties, are taken throughout the period after manufacturing,
also must maintain such quantities of reference samples.
11. comply with the provisions of Drugs and Cosmetics Act, 1940, rules thereunder and
such further requirements time to time published in Official Gazette.
12. maintain an “Inspection Book” in Form 35, to record impressions and defects noticed
by Drug Inspectors.
13. comply with requirements of “Good Manufacturing Practices” as per schedule M.
Pharmaceutical Jurisprudence 1.14 Drugs and Cosmetics Act, 1940 …

14. The licensee having license to manufacture schedule C, C1 and X drugs in Form 28-B
must,
(i) forward to the licensing authority every 3 months, a statement of sale to the
manufacturers, wholesalers, retailers, hospitals, dispensaries, nursing homes, and
registered medical practitioners.
(ii) maintain as prescribed under rules, accounts of all transactions as regard to use,
stock, manufacture, storage and sale of schedule X drugs.
(iii) store always schedule X bulk drugs separately under custody of a responsible
person.
Manufacture of Drugs for Test, Examination and Analysis:
A license is required to manufacture any drug in small quantity for the purpose of
examination, test or analysis purpose.
1. If a person proposing to manufacture does not hold a license to manufacture drugs
specified in Schedule C and C1 or other than Schedule C, C1 and X, shall obtain a
license Form 29 before manufacturing such drugs.
2. The licensee shall carry the manufacture and examination of drugs at the place
specified in the license.
3. In case of drugs which are unsafe for use, a license in Form 29 can be granted only on
producing NOC (no objection certificate) from the licensing authority.
4. Application must be countersigned by the Head of the Institution, which proposes to
undertake the manufacture.
5. License remains valid for a period of 1 year, unless cancelled or suspended.
6. Any drug for the purpose of examination, shall be placed in the containers, labelled
for the purpose of manufacturing it, name and address of the manufacturer.
Thereafter supplied to the any other manufacturer, when necessary.
7. The licensee shall allow Inspector to inspect the premises and satisfy himself that only
examination is conducted.
8. The licensee shall keep a record the quantity of drugs supplied for analysis also
mainatain ‘Inspection Book’.
9. The licensee shall comply with such requirements specified and of which the
authority has given him not less than 1 month’s notice.
Manufacture of New Drugs:
As per the Rule 122 E of the Drug and Cosmetic Rules 1945, a New Drug can be:
1. A new substance of chemical, biological or biotechnological origin; in bulk or
prepared dosage form; used for prevention, diagnosis, or treatment of disease in
man or animal, which except during local clinical trials has not been used in the
Pharmaceutical Jurisprudence 1.15 Drugs and Cosmetics Act, 1940 …

country; and which, except during local clinical trials, has not been recognised in the
country as effective and safe.
2. A drug already approved by the licensing authority for the proposed claims, which is
now proposed to be marketed with modified or new claims; or
A fixed dose combination of two or more drugs, individually approved earlier for
certain claims, which are now proposed to be combined for the first time in a fixed
ratio; or
If the ratio of ingredients in an already marketed combination is proposed to be
changed, with certain claims, like:
(i) Indications.
(ii) Dosage form (including sustained release dosage form).
(iii) Route of Administration.
3. All vaccines shall be new drugs unless certified otherwise by the Licensing Authority.
4. A new drug shall continue to be considered as new drug for a period of four years
from the date of its first approval or its inclusion in the Indian Pharmacopoeia,
whichever is earlier.
Conditions of License:
1. No ‘new drug’ can be manufactured, prior to the approval from the licensing
authority.
2. The applicant, shall submit data as given in Appendix-1 to Schedule Y, including the
results of clinical trials as per the format of Appendix-2 to Schedule Y.
3. While applying for the license, applicant shall furnish the evidence certificate that the
drug has already been approved.
Note: What is a Subsequent New Drug Application?
A Subsequent New Drug application is an application for approval of an already
approved new drug by the Central Drugs Standard Control Organization (CDSCO). It can be
made for the following cases:
1. Bulk Drug already approved in the country (approved within 4 years).
2. New drug (Formulation) already approved in the country.
3. A drug already approved and proposed to be marketed with new indication.
4. A drug already approved and proposed to be marketed as a ‘New Dosage Form /
New Route of Administration’.
5. A drug already approved and proposed to be marketed as a ‘Modified release
dosage form’.
6. A drug already approved and proposed to be marketed with Additional Strength.
Pharmaceutical Jurisprudence 1.16 Drugs and Cosmetics Act, 1940 …

All the applications for approval of New Drug, Fixed Dose Combination and Subsequent
New Drug are made under Form 44 (Application for grant of permission to import or
manufacture a New Drug or to undertake clinical trial).
1.7 LOAN LICENSE
It is issued by the licensing authority, to a person who does not own, arrangements for
manufacture but intends to avail the manufacturing facilities owned by another licensee.
1. In the case of pharmacy business is operating its business in more than two states
then it is required to obtain a drug license in each state where the business is carried
on. A separate license shall be issued in case drugs are sold at more than one place.
2. After the license is granted to the business, the licensee must ensure that all the
conditions of the drug license must be complied with during business. In the case of
any changes or modification in business activity authority must be informed and all
the registers, records, and forms must be maintained in a specified manner.
Sr. Classes of Drugs Form of Form of
No. Application License
1. Loan License (other than Schedule C, C1 and X) 24-A 25-A
2. Loan License (only Schedule C, C1) 27-A 28-A
3. Repacking License (other than Schedule C, C1 and X) 24-B 25-B
3. The licensing authority shall, before the grant of a loan licence, satisfy himself that
the manufacturing unit has adequate equipment, staff, capacity for manufacture, and
facilities for testing, to undertake the manufacture on behalf of the applicant for a
loan licence.
4. Application for manufacture of more than ten items for each category of drug on a
loan licence shall be accompanied by an additional fee of rupees three hundred per
additional item specified in Schedule M and Schedule M3.
5. The licensee shall allow Inspector to inspect the premises and satisfy himself that only
examination is conducted.
6. The licensee shall mainatain ‘Inspection Book’ in Form 35.
7. The licensee shall comply with further requirements specified by the authority.
8. The licensee shall test each batch of raw materials used and each batch of the final
product and also maintain the records of manufacture and testing of each batch as
per schedule U.
9. Shall maintain the reference samples from each batch for the period of 3 years.
10. Report to the licensing authority, regarding the changes in expert staff or change in
the manufacture or testing units.
Pharmaceutical Jurisprudence 1.17 Drugs and Cosmetics Act, 1940 …

11. For Schedule C and C1 drugs, the licensee shall furnish the data of stability and date
of expiry to the licensing authority.
12. If the licensing authority is satisfied that a loan licence is defaced damaged or lost or
otherwise rendered useless, he may, on payment of a fee of rupees one thousand,
issue a duplicate licence.
1.8 REPACKING LICENSE
1. It is granted for the purpose of breaking up any drug than those specified in
Schedule C and C1.

Sr. Classes of Drugs Form of Form of

No. Application License

1. Repacking License (other than Schedule C, C1 and X) 24-B 25-B

1. Repacking of drugs should be conducted under hygienic conditions under personal

supervision of competent person, approved by the licensing authority.
2. The licensee must provide and maintain adequate arrangements for carrying out tests
of drugs repacked, in the specified place by the authority.
3. The licensee shall allow Inspector to inspect the premises and to take samples of
repacked drugs.
4. The licensee shall test each batch of raw materials used and each batch of the final
product and also maintain the records of manufacture and testing of each batch as
per schedule U. Records must be retained for 5 years from the date of repacking.
5. Licensee must allow the Inspector to inspect all the registers and records maintained.
6. The licensee shall mainatain ‘Inspection Book’ in Form 35.
7. Shall maintain the reference samples from each batch of repacked drugs, for the
specified period.
8. Licences remain valid for a period of 5 years from the date its granted or renewed,
unless suspended or cancelled.

EXERCISE
1. Define the terms ‘Misbranded’, Ádulterated’ and ‘Spurious drugs’ according to the
Drugs and Cosmetics act.
2. Write a note on Loan license and Repacking license.
Pharmaceutical Jurisprudence 1.18 Drugs and Cosmetics Act, 1940 …

BIBLIOGRAPHY
1. Shyam Chandak, Pharmaceutical Jurisprudence, 2017, 12.1.
2. Hollister LE and Csernansky JG: Clinical Pharmacology of Psychotherapeutic Drugs.
Churchill Livingstone, New York, Third Edition 1990.
3. Dr. S.P. Agarwal and Dr. Rajesh Khanna, Pharmaceutical Jurisprudence and Ethics,
2017, 37.
4. B.S Kuchekar, Pharmaceutical Jurisprudence, 2016, 5.1.
5. Binay Kumar Jha, Pharmaceutical Jurisprudence, 2014, 34.
6. Drugs and Cosmetic Act (2012) Import of
Newdrughttp://www.cdsco.nic.in/forms/ShowSearchResult.aspx?Search=clinical%20tr
ials
7. K. Dubey, Rajesh Kumar and Pramila Tripathi, Global promotion of herbal medicine:
India’s opportunity - Current Science, 2004, 86(1)
8. N.K. Jain, A Textbook of Forensic Pharmacy, 2014, 49.
✱✱✱
 UNIT II

Chapter ... 2
DRUGS AND COSMETICS ACT, 1940
AND ITS RULES 1945
♦ LEARNING OBJECTIVES ♦
After completing this chapter, the reader should be able to understand:
About the compilation of Drug and Cosmetic Acts 1940 and Rules 1945.
Regulation of import, manufacture, sale and distribution of drugs and cosmetics.
To avoid substandard drugs and to maintain high standards of drugs and cosmetics.
Administration of the D and C Act and Rules.

2.1 DETAILED STUDY OF THE SCHEDULES

Schedule G:
Most of these drugs are hormonal preparations. The drug label must display the text.
"Caution: It is dangerous to take this preparation except under medical supervision"
prominently. Examples: Testolactone, Hydroxyurea, Carbutamide, Primidone, Mercaptopurine,
Methsuximide, Thiotepa etc.
Schedule H:
The drug label must display the texts "Rx" on the left top corner of the label
and "Schedule H drug. Warning : To be sold by retail on the prescription of a Registered
Medical practitioner only" prominently. It can only be supplied to licensed parties. It cannot
be sold without a prescription and only the amount specified in the prescription should be
sold. The time and date of prescription must be noted. Examples: Androgenic, anabolic,
oestrogenic and progestational substances; Alprazolam, Hepatitis B vaccine,
Adrenocorticotrophic hormone, Ibuprofen, Vasopressin etc.
If a Schedule H drug also comes under the purview of Narcotic Drugs and Psychotropic
Substances Act, 1985, it must carry the texts "NRx" in red on the left top corner of the lable
and "Schedule H drug. Warning: To be sold by retail on the prescription of a Registered Medical
Practitioner only." on the label prominently.

(2.1)
Pharmaceutical Jurisprudence 2.2 Drugs and Cosmetics Act, 1940 …

Schedule M (GMP-GOOD MANUFACTURING PRACTICES):

It is defined as “the part of quality assurance which is aimed to ensure that the product
are consistently manufactured to the quality appropriate to their intended use”. It prescribes
the requirements of premises, plant and equipment needed for setting up manufacturing
unit. Also documents every stage of manufacture, packing, storage, transportation checking
and testing of medicinal product, maintenance or keeping records.
Part-1: Requirements for Premises and Materials
1. Locations and Surroundings: The factory building shall be situated and constructed
to avoid contamination from open sewerage, drain, disagreeable or obnoxious odour, dust
and smoke etc.
2. Buildings and Premises: A building for manufacturing unit shall permit work under
hygienic conditions. It should be free from any insects/rodents. Light and ventilation facility
should be adequate. Walls and floor should be free from cracks and damp. Premises should
also be confirmed with provisions of factory act. It shall be located so as to be:
(i) Building should be compatible of other manufacturing operations carried out in same
premises.
(ii) Space should be adequate for placement of equipment and materials to avoid mix-
up/contamination risk of different drugs and components.
(iii) Designed, constructed and maintained to prevent entry of insects and rodents.
Interior surface (walls, floors and ceilings) shall be smooth and free from cracks and
permit easy cleaning and disinfection. The walls of the room in which the
manufacturing operations are carried out shall be impervious to and be capable of
being kept clean.
(iv) The flooring shall be smooth and even and shall be such as not to permit retention or
accumulation of dust or waste products.
(v) Building should have a proper drainage system. Sanitary fitting and electric fixtures
shall be proper and safe.
(vi) Proper fire safety measures and proper exists should be there.
(vii) Drying space for raw material, in process medicines should be separate and measures
should be done to prevent it from flies/insects/dust etc.
3. Water Supply: Water supply should be pure and of potable quality. Adequate
provision of water for wasting the premises shall be made.
4. Disposable of Waste:
(i) Disposal of sewage and effluents from the factory should be as per “Environment
Pollution Control Board’’.
(ii) All bio-medical wastes should be destroyed as per “Biomedical Waste management
rules-1996”.
(iii) Hazardous, toxic and inflammable substances should be stored in suitably designed
and segregated in enclosed areas, as prescribed by Central and State legislations.
Pharmaceutical Jurisprudence 2.3 Drugs and Cosmetics Act, 1940 …

5. Stores: Store should have adequate space for independently and separately store
raw material, packaging material and finished products.
6. Working Space: Manufacturing area should be adequate for orderly placement of
equipment, machinery and material used during manufacturing operations and quality
control to facilitate easy and safe working and to minimize or eliminate any risk of mix-up
between different drugs, raw materials and to prevent the cross contamination during
manufacturing, storage and handling operations.
7. Sterile Products: For the manufacture of sterile products separate enclosed areas
shall be provided with the air lock system for the entry and shall be essentially dust free and
ventilated with an air supply for all areas where aseptic manufacturing has to be carried out.
Air supply shall be filtered through bacteria proof filter (HEPA filter) and shall be at a pressure
higher than in the adjacent area. The filter shall be checked for performance an installation
and periodically there after, and records there of shall be maintained.
The entire surface in the manufacturing area shall be designed to facilitate cleaning and
dis-infections. Routine microbial counts to facilitate cleaning and dis-infections. Routine
microbial counts of all sterile area shall be carried out during manufacturing operation.
The resultant of each shall be checked against established house standards and record
maintained. Access to manufacturing area shall be restricted to minimum number of
authorized personal. Special procedure to be followed for entering and leaving the
manufacturing area shall be written down and displayed.
8. Container’s Cleaning: Washing, cleaning and drying section of containers such as
bottles, vials and jars should have adequate arrangement and should be separated from
manufacturing operations.
9. Machinery: To carry out manufacturing process, adequate machinery and equipment
require. These machinery could be manually operated or semi-automatic or fully automatic
based upon your need and investment.
10. Raw-Materials: The licensee shall keep on inventory of all raw material to be used at
any stage of manufacture of drugs and maintain the record as per schedule U. All such raw
material be:
(a) Identified and their container examined for damage and assigned control number.
(b) Stored at optimum temperature and relative humidity.
(c) Conspicuously labelled indicating the number of materials, control numbers, name of
manufacture and be labelled 'under test' or 'approved' or 'rejected'.
(d) Systematically sampled by quality control personnel.
(e) Tested for compliance with required standard of quality.
(f) Released from quarantine by quality control personal through written instruction.
(g) The stock rotation is so organized that, it is on the basis of first come first out.
(h) The all rejected material are conspicuously identified and are destroyed or returned
to the supplier as soon as possible and record maintained there of.
Pharmaceutical Jurisprudence 2.4 Drugs and Cosmetics Act, 1940 …

11. Equipment: Equipment used for the manufacturing of drugs shall be constructed
designed, installed and maintained to
(i) Achieve operational efficiency to attain desired quality.
(ii) Prevent physical, chemical and physico-chemical change through surface
contact.
(iii) Prevent contact of any substance required for operation of the equipment like
lubricant etc.
(iv) Facilitate through cleaning wherever necessary.
(v) Minimize any contamination of drug and their container during manufacture.
(vi) Equipment used for critical steps in progress shall be maintained by device
capable of recording the parameter or with drawn systems to indicate
malfunction. These devices shall be calibrated and tested and recorded there of
shall be maintained.
12. Batch Manufacturing Record: Each batch record should be maintained irrespective
of product manufactured (classical preparations or patent or proprietary medicines).
(i) Manufacturing records are required to provide an account of the list of raw materials
and their quantities obtained from the store, tests conducted during the various
stages of manufacture like taste, colour, physical characteristics and chemical tests as
may be necessary or indicated in the Drugs and Cosmetics Act.
(ii) These tests may include any in-house or pharmacopoeial test adopted by the
manufacturer in the raw material or in the process material and in the finished
product.
(iii) Manufacturing Batch record should be signed by production chemist and analytical
chemist. Stock should be transferred to finished goods store along with record of
testing with date and quantity of drug.
(iv) Only after the manufactured drugs have been verified and accepted quality shall be
allowed to be cleared for sale.
(v) It should be essential to maintain the record of date, manpower, machine and
equipments used.
Master Formula Records:
The licensee shall maintain MFR relating to all manufacturing procedure for each product
which will be prepared and endorsed by the competent technical staff that is head of
production and quality control. The master formula record should have:
(a) The patent or propriatory name of the product along with generic name, if any,
strength and the dosage form.
(b) A description of identification of the final container packing material label and closer
to be used.
Pharmaceutical Jurisprudence 2.5 Drugs and Cosmetics Act, 1940 …

(c) The identity and quality of the raw material to be used irrespective of whether or not
it appear in the finished product, the permissible averages that may be included in
formulation batch, should be indicated.
(d) Description of all vessel and equipment and the size used in the progresses.
(e) Manufacturing and control instruction along with parameter for critical steps such as
mixing, drying, blending, sieving and sterilizing the product etc.
(f) The theoretical yield to be expected from the formulation at different stage of
manufacture and permissible yield limit.
(g) Detail instruction on precaution to be taken in manufacture and storage of drug and
of semi-finished product.
The requirement of in processes quality control test and analysis to be carried out during
each step of manufacture including designation of person or department responsible for
execution of such test and analysis.
13. Health Clothing, Sanitation and Hygiene of Workers:
(i) All workers should be healthy and should be free from any contagious diseases.
(ii) Proper uniform should be provided to workers according to nature of work and the
climates.
(iii) A uniform may include cloth or synthetic covering for hands, feet and head wherever
required.
(iv) Adequate facilities for personnel use should be provided like clean towel, soap etc.
Lavatories for men and women should be separate and should be away from
processing and manufacturing area.
(v) Changing room facility should also be provided for changing their clothes and to
keep their personal belongings.
14. Medical Services: Adequate facility for first aids should be provided by
manufacturer. Medical examination of workers at the time of employment and periodical
check-up should be conducted at least once in a year and proper record should be
maintained.
15. Distribution Record: Distribution record (Dispatch register) should be maintained to
facilitate process of prompt and complete recall of the batch. Distribution record should be
maintained till expiry of batch.
16. Record of Market Complaints: A complain register should maintain to record all
reports of market complaints received regarding the products sold in the market. The
manufacturer shall enter all data received on such market complaints, investigations carried
out by the manufacturers regarding the complaint as well as any corrective action initiated to
prevent recurrence of such market complaints shall also be recorded. Once in a period of six
months the manufacturer shall submit the record of such complaints to the licensing
Pharmaceutical Jurisprudence 2.6 Drugs and Cosmetics Act, 1940 …

authority. The Register shall also be available for inspection during any inspection of the
premises.
Reports of any adverse reaction resulting from the use of drugs shall also be maintained
in a separate register by each manufacturer. The manufacturer shall investigate any of the
adverse reaction to find if the same is due to any defect in the product, and whether such
reactions are already reported in the literature or it is a new observation.
17. Quality Control: A manufacturer can set-up own quality control section or testing
could be done through government approved testing laboratory.
Part-2: Requirements for Plant and Equipments
1. Area:
(i) Basic installation - Requires minimum of 30 sq. mt. (for tablets manufacturing,
upto 60 sq. mt.)
(ii) Ancillary area: 10 sq. mt. (for tablets manufacturing, upto 20 sq. mt.)
2. Equipment: Colloidal mill, mixing and storage tanks, stainless steel containers,
Planetary mixer, Triple roller, tube filling equipments, filter proof cap sealing machine,
water distillation unit, clarity testing inspection unit, disintegrator and sifter,
granulator, tray or fluidized bed driers, weighing machine, tablet compression
machine (single-multi-rotary punch), tablet inspection unit, dissolution test
apparatus, hardness tester, friability tester, disintegration test apparatus, air
conditioners, polishing pan, jacketed kettle, leakage test apparatus, capsule filling
unit, hot air ovens, Laminar air flow unit, bottle washing machines, autoclave, transfer
pumps, trimming machine, cutting machine etc.
Parts of Schedule M
Part 1: Describes Good Manufacturing Practices For Premises and Material.
Part 1A: Describes the specific requirement for manufacture of sterile products.
Parenteral preparations (Small Volume Injections and Large Volume Parentrals) and Sterile
Ophthalmic Preparations.
Part 1B: Describes the specific requirements for manufacture of oral solid forms (Capsule
and Tablets)
Part 1C: Describes the specific requirements for manufacture of oral liquids (syrups,
elixirs, emulsions and suspensions).
Part 1D: Describes the specific requirements for manufacture of topical products
i.e. External Preparations (Cream, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting
Powders and Identical Products)
Part 1E: Describes the specific requirements for manufacture of Metered Dose Inhalers
(MDI).
The other associated codes such as those of Good laboratory practice (GLP) and Good
clinical practice (GCP).
Pharmaceutical Jurisprudence 2.7 Drugs and Cosmetics Act, 1940 …

Schedule N:
Describes the facilities and equipments for efficient running of a Pharmacy.
1. Entrance: Front of a pharmacy shall bear an inscription “Pharmacy” in front.
2. Premises:
(i) Separated from rooms, well built, dry, well lit and ventilated with sufficient
dimensions for stock of medicaments.
(ii) Poisons to be kept in a clearly visible and appropriate manner.
(iii) Dispensing department shall be not less than 6 sq. m. for one pharmacist
working therein with additional 2 sq. m. for each additional pharmacist.
(iv) Height of the premises shall be at least 2.5 metres.
(v) Floor of the pharmacy shall be smooth and washable.
(vi) Walls shall be plastered or tiled or oil painted so as to maintain smooth, durable
and washable surface devoid of holes, cracks and crevices.
(vii) A pharmacy shall be provided with ample supply of good quality water.
(viii) The dispensing department shall be separated by a barrier to prevent the
admission of the public.
3. Furniture and Apparatus:
(i) A pharmacy shall contain furniture and apparatus, drawers, containers, glasses of
suitable sizes and designed to prevent dust entry.
(ii) Every container shall bear a labels, easily readable with names of medicaments as
given in the Pharmacopoeias.
(iii) Shall be provided with a dispensing bench, washable top etc.
(iv) Separate cupboards with lock and key for Poisons, and shall be marked in red
letters as ‘’POISON’’ on a white background.
(v) All concentrated solutions shall be labelled as ‘’To be diluted’’.
(vi) Pharmacy shall bear all the prescribed apparatus and books for official
preparations and prescriptions.
(a) Balance
(b) Beakers, bottles, funnels
(c) Filter and litmus papers
(d) Mortar and pestle, other glasswares
(e) Spatula, scissors, stands
(f) Spirit lamp, thermometer
(g) Water bath, distillation apparatus
(h) Watch glasses, pill machines, suppository mould etc.
Pharmaceutical Jurisprudence 2.8 Drugs and Cosmetics Act, 1940 …

(i) Books: The Pharmacopoeia (current edition), National Formulary of India,

The Drugs and Cosmetic Act 1940 and rules 1945, The Pharmacy Act,
Narcotic and Psychotropic substances Act, 1985 etc.
4. General provisions: Pharamcist shall always wear a clean white overalls, records and
registers shall be maintained as per the law, medicaments must bear labels when supplied as
per the law.
Schedule P:
Schedule P describes the life period of drugs in months (unless otherwise specified)
between date of manufacture and date of expiry which the labelled potency period of the
drug shall not exceed under the conditions of storage specified.
Sr. Drug Life period in Storage conditions
No. months
1. Ampicillin 36 Cool place
2. Bacitracin 18 Cool place
3. Carbanicillin sodium injection 24 At temp. not exceeding 5°C.
4. Colistin sulphate 60 Protected from light
5. Erythromycin stearate 36 Cool place
Note: Cool place means, a temperature of 10-25°c
Schedule P1:
Pack sizes of drugs
Sr. Drug Dosage form Pack size
No.
1. Albendazole Suspension 10 ml
2. Atenolol Tablets 14
3. Piperazine Granules 5 gm
Schedule T:
Contains various regulations and requirements for manufacture of Ayurvedic, Siddha and
Unani products.
Part 1: Describes the Good Manufacturing Practice of Ayurvedic, Sidha and Unani
Medicines.
A Manufacturing Premises should have adequate space for all daily activity like:
1. Receiving and Storage of Herbs, Packaging material and other raw material.
2. Production and Manufacturing Activity Area.
3. Quality Control Section.
4. Finished Goods Store.
5. Office and Administration.
Pharmaceutical Jurisprudence 2.9 Drugs and Cosmetics Act, 1940 …

6. Rejected Products/Drugs Store.

7. Minimum area required for setting up Ayurveda, Sidha and Unani Medicine
manufacturing unit is 1200 sq. ft. covered with separate cabins and partitions for
each activity. If unani medicines/ayurvedic medicines are manufactured along with
ayurvedic medicines/unani medicines additional 400 sq. ft. area is required.
General Requirements:
1. Location and Surroundings: The factory building shall be situated and constructed
to avoid contamination from open sewerage, drain, disagreeable or obnoxious odour, dust
and smoke etc.
2. Buildings: A building for manufacturing unit shall permit work under hygienic
conditions. It should be free from any insects/rodents. Light and ventilation facility should be
adequate. Walls and floor should be free from cracks and damp. Premises should also be
conformed with provisions of factory act. It shall be located so as to be:
(i) Building should be compatible of other manufacturing operations carried out in
same premises.
(ii) Space should be adequate for placement of equipment and materials to avoid
mix-up/contamination risk of different drugs and components.
(iii) Designed, constructed and maintained to prevent entry of insects and rodents.
Interior surface (walls, floors and ceilings) shall be smooth and free from cracks
and permit easy cleaning and disinfection. The walls of the room in which the
manufacturing operations are carried out shall be impervious to and be capable
of being kept clean.
(iv) The flooring shall be smooth and even and shall be such as not to permit
retention or accumulation of dust or waste products.
(v) Building should have a proper drainage system. Sanitary fitting and electric
fixtures shall be proper and safe.
(vi) Burner/Bhatti section could be covered with tin roof and proper ventilation, but
care should be done to prevent flies and dust.
(vii) Proper fire safety measures and proper exists should be there.
(viii) Drying space for raw material, in process medicines should be separate and
measures should be done to prevent it from flies/insects/dust etc.
3. Water Supply: Water supply should be pure and of potable quality. Adequate
provision of water for wasting the premises shall be made.
4. Disposable of Waste: Proper waste management care should be done.
5. Container’s Cleaning: Washing, cleaning and drying section of containers such as
bottles, vials and jars should have adequate arrangement and should be separated from
manufacturing operations.
Pharmaceutical Jurisprudence 2.10 Drugs and Cosmetics Act, 1940 …

6. Stores: Store should have adequate space for independently and separately store
raw material, packaging material and finished products.
7. Working Space: Manufacturing area should be adequate for orderly placement of
equipment, machinery and material used during manufacturing operations and quality
control to facilitate easy and safe working and to minimize or eliminate any risk of mix-up
between different drugs, raw materials and to prevent the cross-contamination during
manufacturing, storage and handling operations.
8. Health Clothing, Sanitation and Hygiene of Workers:
(i) All workers should be healthy and should be free from any contagious diseases.
(ii) Proper uniform should be provided to workers according to nature of work and the
climates.
(iii) A uniform may include cloth or synthetic covering for hands, feet and head wherever
required.
(iv) Adequate facilities for personnel use should be provided like clean towel, soap etc.
Lavatories for men and women should be separate and should be away from
processing and manufacturing area.
(v) Changing room facility should also be provided for changing their clothes and to
keep their personal belongings.
9. Medical Services: Adequate facility for first aids should be provided by
manufacturer. Medical examination of workers at the time of employment and periodical
check-up should be conducted at least once in a year and proper record should be
maintained.
10. Machinery and Equipment: To carry out manufacturing process, adequate
machinery and equipment require. These machinery could be manually operated or semi-
automatic or fully automatic based upon your need and investment.
11. Batch Manufacturing Record: Each batch record should be maintained irrespective
of product manufactured (classical preparations or patent or proprietary medicines).
(i) Manufacturing records are required to provide an account of the list of raw materials
and their quantities obtained from the store, tests conducted during the various
stages of manufacture like taste, colour, physical characteristics and chemical tests as
may be necessary or indicated in the approved books of Ayurveda, Siddha and Unani
mentioned in the First Schedule of the Drugs and Cosmetics Act.
(ii) These tests may include any in-house or pharmacopoeial test adopted by the
manufacturer in the raw material or in the process material and in the finished
product.
(iii) Manufacturing batch record should be signed by production chemist and analytical
chemist. Stock should be transferred to finished goods stored along with record of
testing with date and quantity of drug.
Pharmaceutical Jurisprudence 2.11 Drugs and Cosmetics Act, 1940 …

(iv) Only after the manufactured drugs have been verified and accepted, quality shall be
allowed to be cleared for sale.
(v) It should be essential to maintain the record of date, manpower, machine and
equipments used and to keep in process record of various shodhana, bhavana,
burning and fire and specific grindings in terms of internal use.
12. Distribution Record: Distribution record (Dispatch register) should be maintained to
facilitate process of prompt and complete recall of the batch. Distribution record should be
maintained till expiry of batch. For drugs who do not have expiry date like Bhasma, Rasa,
Asava-arishtha etc. record should be maintained upto five years of the exhausting of stock.
13. Record of Market Complaints: A complaint register should be maintained to record
all reports of market complaints received regarding the products sold in the market. The
manufacturer shall enter all data received on such market complaints, investigations carried
out by the manufacturers regarding the complaint as well as any corrective action initiated to
prevent recurrence of such market complaints shall also be recorded. Once in a period of six
months the manufacturer shall submit the record of such complaints to the licensing
authority. The Register shall also be available for inspection during any inspection of the
premises.
Reports of any adverse reaction resulting from the use of Ayurvedic, Siddha and Unani
drugs shall also be maintained in a separate register by each manufacturer. The manufacturer
shall investigate any of the adverse reaction to find if the same is due to any defect in the
product, and whether such reactions are already reported in the literature or it is a new
observation.
14. Quality Control: A manufacturer can set-up own quality control section or testing
could be done through government approved testing laboratory read in detail
about Ayurvedic, Sidha and Unani manufacturing unit quality control section.
Part 2: Describes list of recommended machinery, equipment and manufacturing
premises required for the manufacture of various categories of Ayurvedic, Siddha system of
medicines.
Anjana/Pisti: End runner/Ball-Mill, Sieves/Shifter.
Churna/Nasya/Manjan/Lepa: Grinder/disintegrator, Pulveriser, Powder mixer, Sieves/
shifter.
Pills/Vati/Gutika Matirai and Tablets: Ball Mill, Mass mixer/powder mixer, Granulator,
Drier, Tablet compressing machine, Pill/vati cutting machine, trays/container for storage and
sugar coating, Polishing pan in case of sugar-coated tablets, Mechanised chattoo (for mixing
guggulu).
Kupi pakava/Ksara/Parpati/Lavana/Bhasma/Satva/Sindura Karpu/Uppu/Param:
Bhatti, Karahi/Vessels/Patila Flask, Multani Matti/Plaster of Paris.
Pharmaceutical Jurisprudence 2.12 Drugs and Cosmetics Act, 1940 …

Copper rod, Earthen container, Gaj Put Bhatti, Muffle furnace (Electrically operated),
End/Edge runner, Exhaust fan, Wooden/Steel spatula.
Kajal: Filling/ packing and manufacturing room should be provided with exhaust fan and
ultra violet lamps, Earthern lamps for collection of Kajal, Triple roller mill, End runner, Sieves.
Capsules: Air conditioner, De-humidifier, Hygrometer, Thermometer, Capsule filling
machine and chemical balance.
Ointment/Marham Pasai: Tube filling machine, Crimping Machine/Ointment Mixer, End
Runner/ Mill, Storage Container.
Pak/Avaleh/Khand/Modak/Lakayam: Bhatti section fitted with exhaust fan and should
be fly proof, Iron Kadahi, Storage container.
Panak, Syrup/Pravahi Kwath Manapaku: Tincture press, Exhaust fan fitted and fly
proof, Bhatti section, Bottle washing machine, Filter press / Gravity filter, Liquid filling
machine, Capping machine.
Asava-Aristha: Fermentation tanks, Containers and distillation plant where necessary,
Filter press.
Sura: Distillation plant, Transfer pump.
Ark Tinir: Maceration tank, Distillation plant, Liquid filling tank with tap, Gravity
filter/Filter press, Visual inspection box.
Tail/Ghrit Ney: Bhatti, Kadahi/Patila, Storage containers, Filtration equipment, Filling
tank with tap, Liquid filling machine.
Aschyotan/Netra Malham Panir/Karn Bindu/Nasa-bindu: Hot air oven electrically
heated with thermostatic control, Kettle gas or electrically heated with suitable mixing
arrangements, Collation mill or ointment mill, Tube filling equipment, Mixing and storage
tanks of stainless steel or of other suitable material sintered glass funnel, Seitz filter or filter
candle, Liquid filling equipment, Autoclave.
Each manufacturing unit will have a separate area for Bhatti, furnace boilers, puta etc. This
will have proper ventilation, removal of smoke, prevention of flies, insets, dust etc. The
furnace section could have tin roof.
Schedule U:
Schedule U describes the particulars to be shown in manufacturing record, records of raw
materials and analytical drugs.
Following details are included in Schedule U:
1. Manufacturing Records:
(i) Substances other than Parenteral Preparation: Serial number, Product name,
Reference of Master formula records, Batch size and number, Date-time-duration
conditions of the process for manufacture, Name of all the ingredients,
Specifications, Quantity required, References to analytical report number,
Pharmaceutical Jurisprudence 2.13 Drugs and Cosmetics Act, 1940 …

theoretical yield and actual production yield of finished product, specimen of

label, date of release of finishes packagings etc.
(ii) Parenteral Preparations: All the above including, Sterility tests such as Leakage,
Pyrogen, Clarity and Toxicity tests; records of sterilization etc.
2. Records of Raw Materials: Date of receipt, Invoice number, Name and address of the
manufacturer/supplier, Batch number, Quantities received, Pack size, Dates of manufacture
and expiry, Date of analysis and release/rejection by quality control, Analytical report number
with special remarks, quantity and date of issue etc.
3. Particulars to be recorded in the Analytical Records.
(i) Tablet, Capsules and for other drugs: Analytical report number, Sample name,
Date of receipt, Batch number, Protocols of test applied, Signature of analyst etc.
(ii) Parenteral Preparations: All the above including, sterility tests.
(iii) Raw Materials: Serial number, Number of materials, Name of manufacturer/
supplier, Quantity received, Challan/invoice number and date, Protocols for test
applied.
(iv) Container and Packing Material: All the above including, Results of tests,
Remarks, Signature of examiner etc.
Schedule UI:
Schedule UI describes the particulars to be shown in the manufacturing record for
cosmetics:
1. Manufacturing Records: Serial number, Product name, Reference of Master formula
records, Batch size and number, Date-time-duration conditions of the process for
manufacture, Name of all the ingredients, specifications, quantity required, references
to analytical report number, theoretical yield and actual production yield of finished
product, specimen of label, date of release of finishes packagings, etc,.
2. Records of Raw Materials: Date of receipt, invoice number, name and address of the
manufacturer/supplier, batch number, quantities received, pack size, dates of
manufacture and expiry, date of analysis and release/rejection by quality control,
analytical report number with special remarks, quantity and date of issue etc.
Schedule V:
Schedule V describes the standards for patent or proprietary medicines.
Patent or Proprietary medicines containing vitamins for prophylactic, therapeutic or
paediatric use shall contain the vitamins in quantities not less than and not more than those
specified in single or in two divided daily doses.
Pharmaceutical Jurisprudence 2.14 Drugs and Cosmetics Act, 1940 …

Sr. Drug Unit Adult (daily dose)

No.
1. Vitamin A I.U. NLT 5,000 and NMT 10,000
2. Vitamin D I.U. NLT 400 and NMT 1,000
3. Vitamin B1 Mg NLT 4.5 and NMT 10
4. Vitamin B6 Mg NLT 1.5 and NMT 3
NLT - Not less than; NMT - Not more than; I.U. - International units
Schedule X:
Drugs which are habit forming, psychotropic and other drugs likely to be misused for
addictive purposes. Hence import, manufacture, sale and distribution of these are regulated
under special provisions.
All the regulations of Schedule H apply. The retailer must keep a copy of the prescription
for two years. The drugs must be kept under lock and key. Examples: Amphetamine,
Secobarbital, Glutethimide, Cyclobarbital, Phencyclidine, Phenobarbital etc.
Schedule Y:
Describes requirements and guidelines on Clinical trials for import and manufacture of
new drugs.
1. Clinical Trials
(i) Permission of trials: One must apply for Form 12 for test license (TL). The application
shall comprise-data for various phases, protocol for proposed trials, case report
forms to be used, names of Investigators and Institutions.
(ii) Responsibility of Sponsor/ Investigator: Sponsors must submit the annual status
report of each clinical trial, to the licensing authority. Any termination, unusual,
unexpected or serious adverse drug reactions (ADR) detected during trial must be
communicated to the authority.
(iii) In all trials, informal, written, voluntary consent must be obtained from each
volunteer in the prescribed forms.
2. Data required to be submitted with the application for permission to market
New Drug
(i) Clinical and Pharmaceutical Informations.
(ii) Animal toxicology: Acute, chronic, reproduction status (fertility, teratogenic and
prenatal studies, local toxicology, mutagenicity, carcinogenicity).
(iii) Animal pharmacology.
(iv) Phase - 1,2,3 trials.
(v) Special studies (bioavailability and dissolution studies).
Pharmaceutical Jurisprudence 2.15 Drugs and Cosmetics Act, 1940 …

Phase 1 trials (Human/Clinical Pharmacology): Determines the maximum tolerated

dose in humans; pharmacodynamics effects, adverse effects etc.
Phase 2 trials (Exploratory Trials): Determines the therapeutic doses, effective dose
range, safety and pharmacokinetics.
Phase 3 trials (Confirmatory Trials): To obtain sufficient evidences about the efficacy
and safety of the drugs.
The reports of the complete trials shall be submitted by the applicant duly signed by the
investigator within a specified period of time. It should include description, actions,
indications, dosage precautions, drug interactions, warning and adverse reactions.
Schedule F:
This contains regulations and standards for running a blood bank.
Schedule FI:
This contains regulations and standards for bacterial vaccines, viral vaccines, antisera and
diagnostic agents.
Schedule F2:
This contains regulations and standards for surgical dressing.
Schedule F3:
This contains regulations and standards for umbilical tapes (polyester and cotton tapes).
Schedule FF:
This contains regulations and standards for ophthalmic preparations (solutions,
suspensions and ointments). The label must bear:
(i) The statement “use the solution within one month after opening the container”.
(ii) Name and concentration of the preservative used.
(iii) ‘’Not for Injection’’.
(iv) Storage instructions.
(v) Warning
(a) If irritation persists or increases, discontinue the use and consult physician.
(b) Do not touch the dropper tip or the other dispensing tip to any surface since this
may contaminate the solution.
Part XII-B:
Requirements for the premises, personnel, equipments and organizations and operation
of a Blood Bank and/or for preparation of Blood components. It’s a part under Schedule F.
I. Blood Banks/Blood Components:
(i) General
(ii) Accommodation for a Blood Bank
(iii) Personnel
(iv) Maintenance
(v) Equipments and instruments
(a) BP apparatus
(b) Stethoscope
Pharmaceutical Jurisprudence 2.16 Drugs and Cosmetics Act, 1940 …

(c) Blood bags (single, double, triple, quadrapole)

(d) Donor questionnaire
(e) Weighing device for donors
(f) Weighing device for blood bags
(g) Artery forceps, scissors
(h) Stripper for blood tubing
(i) Bed sheets, blankets/mattress
(j) Lancets, swab stick/tooth picks
(k) Glass slides
(l) Portable Hb meter/copper sulphate 337
(m) Test tube (big) and 12 × 100 mm (small)
(n) Test tube stand
(o) Anti-A, Anti-B and Anti-AB, Antisera and Anti-D
(p) Medicated adhesive tape
(q) Plastic waste basket
(r) Donor cards and refreshment for donors
(s) Emergency medical kit
(t) Insulated blood bag containers with provisions for storing between 2°C to
10°C.
(u) Dielectric sealer or portable tube sealer
(v) Needle destroyer (wherever necessary)
(vi) Supplies and Reagents
(vii) Good Manufacturing Practices (GMPs)/ Standard Operating Procedures (SOPs)
(viii) Criteria For Blood Donation
(ix) Special Reagents
(x) Testing of whole blood
(xi) Records
(xii) Labels
II. Blood Donation Camps:
(i) Premises, personnel etc.
(ii) Personnel for Out-door Blood Donation Camp.
(a) One Medical Officer and two nurses or phlebotomists for managing 6-8 donor
tables.
(b) Two medico social workers.
(c) Three blood bank technicians.
Pharmaceutical Jurisprudence 2.17 Drugs and Cosmetics Act, 1940 …

(d) Two attendants.

(e) Vehicle having a capacity to seat 8-10 persons, with provision for carriage of
donation goods including facilities to conduct a blood donation camp.
(iii) Equipments.
III. Processing of Blood Components from Whole Blood by a Blood Bank:
(i) Accommodation
(ii) Equipment
(iii) Personnel
(iv) Testing Facilities
(v) Categories of Blood Components
(a) Concentrated Human Red Blood Corpuscles
(b) Platelets Concentration
(c) Granulocyte Concentration
(d) Fresh Frozen Plasma
(e) Cryoprecipitate
Drug and Magic Remedies (Objectionable Advertisements):
The act defines "magic remedy" as any talisman, mantra, kavachas or any other object
which is claimed to have miraculous powers to cure, diagnose, prevent or mitigate a disease
in humans or animal. It also includes such devices that are claimed to have power to
influence structure or function of an organ in humans or animals.
The law prohibits advertising of drugs and remedies for −
(i) Inducing miscarriage or preventing conception in women.
(ii) Improving or maintaining the capacity for sexual pleasure.
(iii) Correction of menstrual disorders.
(iv) Curing, diagnosing or preventing any disease or condition mentioned in an included
schedule.
2.2 SALE OF DRUGS
2.2.1 Wholesale, Retail and Restricted Sale Licenses
1. Wholesale: From stockists to shopkeepers.
2. Retail sale: From shopkeepers (drug store, chemists and druggists, pharmacy or
dispensing chemist) to patients.
Drug control organization issues two type of license, out of which one is Retail Drug
License (RDL) to run a chemist shop, and it is issued to only those persons who possess
degree or diploma in pharmacy from a recognized university on the payment of the requisite
fees and other is Wholesale Drug License (WDL) which is issued to a person who is engaged
in the business of wholesale of drugs and medicines.
Pharmaceutical Jurisprudence 2.18 Drugs and Cosmetics Act, 1940 …

Sr. Type of License Forms

No.
Other than Schedule-C and Schedule-X
Schedule-C, C1 Drugs drugs
C1 and X
drugs
1. Retail 20 21 20-F
2. Restricted 20-A 21-A --
3. Wholesale 20-B 21-B 20-G
4. Wholesale or distribution 20-BB 21-BB --
from motor vehicle
Conditions of Whole Sale License:
1. Area: Shall not be less than 10 sq. m.
2. Storage: It is necessary to have a refrigerator and air conditioner on the premises
because certain drugs such as vaccines, insulin injections etc. are needed to be stored
in the fridge.
3. Competent Staff: The sale can be made either by a registered pharmacist or
another competent person who must be a graduate with one year experience in
drugs or in the presence of any one who has passed S.S.L.C having experience of four
years in drugs, specially approved by drug control department.
4. License shall be displayed in a prominent place.
5. The drugs shall be purchased from a duly licensed dealer or a manufacturer.
6. Supply of drugs shall be made against a cash memo. Carbon copies of the same shall
be preserved for 3 years from the date of last entry.
7. Shall maintain the records of purchase, and produce all the registers and records
during inspection. Records must be preserved for 2 years from the last entry.
8. An Inspection book shall be maintained in Form 35.
9. The drugs after expiry, Physician’s sample and the drugs meant for Government
supply, shall not be stocked or sold.
10. A separate record shall be maintained for the supply of Schedule X drugs, the copies
of invoices of sale of such drugs to the retailer, shall be forwarded to the Licensing
authority.
11. No sale of any drug should be made for the purpose of resale to a person not
holding the license to sell or distribute the drugs.
Pharmaceutical Jurisprudence 2.19 Drugs and Cosmetics Act, 1940 …

Conditions of Restricted License:

These are issued for the retail sale of the drugs.
Restricted licences in Forms 20A and 21A.
(a) Dealers or persons in respect of drugs whose sale does not require the supervision
of a qualified person.
(b) Licenses to itinerant vendors shall be issued only in exceptional cases for bonafide
travelling agents of firms dealing in drugs.
(c) The licensing authority may issue a license in Form 21A to a travelling agent of a firm
but to no other class of itinerant vendors for the specific purpose of distribution to
medical practitioners or dealers samples of biological and other special products
specified in Schedule C.
(d) The licensee must have adequate premises equipped with facilities for the proper
storage of which the license applies, provided that, this condition does not apply to
the vendors.
(e) License should be displayed in a prominent place in a part of the premises open to
the public or must be kept on the person of vendor who shall produce the same on
demand by authorized government officers.
(f) Licensee must comply with the provisions of D and C act.
(g) Drugs should be purchased only from a duly licensed dealer or manufacturer.
(h) The licensee can deal only with such drugs, which can be sold without the supervision
of a qualified person.
(i) Drugs must be sold in their original container.
Required Documents for Obtaining Drug License:
1. Application Form.
2. Cover letter with the name and designation of the applicant.
3. Copy of challan achieved by depositing fees for obtaining drug license.
4. Declaration in a prescribed manner.
5. Kite plan and site plan for the premises.
6. The basis of possession of premises.
7. In the case of rented property, ownership proof.
8. Document related to the constitution of business such as Incorporation certificate/
MOA (Memorandum of association)/AOA (Articles of association)/Partnership Deed.
9. Affidavit related to non-conviction of director/partner/proprietor.
10. Testimony of registered pharmacist or competent person and their appointment
letter in case of an employed person.
Pharmaceutical Jurisprudence 2.20 Drugs and Cosmetics Act, 1940 …

2.2.2 Offences and Penalties

Offences and penalties relating to the Sale of drugs:
Sr. Offence Penalties
No.
First conviction Subsequent
conviction
1. Sale or distribution of:
(i) Any adulterated or Imprisonment upto 5 years Imprisonment upto
spurious drugs or drug and extending upto lifetime 10 years or fine upto
not of standard quality and fine of not less than ` 20,000 or both.
` 10,000.
(ii) Any adulterated but not Imprisonment from 1-3 and Imprisonment for 2-4
containing toxic or fine of not less than ` 5,000 years or fine upto
harmful substances ` 10,000.
injurious to health
(iii) Without a license Imprisonment of less than a Imprisonment for not
year and a lesser fine. less than 2 years or
fine upto ` 10,000.
(iv) Spurious drugs but not Imprisonment for 3-5 years Imprisonment for not
manufactured under the and fine of not less than less than 6-10 years
name of any other drug ` 5,000. or fine upto ` 10,000.
(v) Any other Imprisonment for 1 year.
(vi) Contravention of this act Imprisonment from 1-2 Imprisonment for 2-4
years and fine. years or fine upto
` 5,000 or both.
2. Not keeping records of sale in Imprisonment upto 3 years Same as first
the specified manner. or fine upto ` 1000 or both. conviction
3. Using the report of Fine upto ` 500 Imprisonment upto
Government analyst for 10 years or with fine
advertising any drug. or both.
2.3 LABELLING AND PACKING OF DRUGS AND COSMETICS
2.3.1 General Labelling Requirements
The following particulars shall be either printed or written in indelible ink and shall
appear in a conspicuous manner on the label of the innermost container of any drug and on
every other covering in which the container is packed:
Pharmaceutical Jurisprudence 2.21 Drugs and Cosmetics Act, 1940 …

1. Drug name: the proper name of the drug shall be printed or written in a more
conspicuous manner than the trade name, if any.
2. Net content: weight, volume, in metric system or units.
3. Content of Active ingredients:
(i) Oral liquids: Contents per single dose, i.e. 5 ml or multiple thereof. If dose is
below 5 ml, then per ml.
(ii) Liquid parenterals: Contents per ml or in percentage or per dose.
(iii) Solid parenterals: Contents per mg or per gm or in terms of units.
(iv) Tablets, capsules and pills: Contents per tablet, capsule, pill.
(v) For other preparations: Contents in terms of percentage by w/w or w/v or units
per gm or ml.
4. Name and address of manufacturer.
5. Manufacturing license number: Mfg. Lic. No. or ML No.
6. Batch number: Batch No. or Lot No.
7. Date of manufacturing: Mfg. Date.
8. Date of expiry: Exp. Date
9. Free samples to medical profession: "Physician’s Sample - Not To Be Sold".
10. Alcoholic preparations: If alcoholic content exceeds 3% by volume, percentage of
alcohol must be mentioned on the lable.
11. Information of handling, use, distribution, storage etc.
12. Maximum Retail Price: M.R.P.
13. Hair dyes containing coal tar colours: on inner and outer label both, in English and
local languages: “Caution: The product contains ingredients which may cause skin
irritation in certain cases and so preliminary test according to the accompanying
directions shall first be made. This product shall not be used for dyeing the eyelashes
or eyebrows as such if used, may cause blindness’’.
14. Toothpaste containing Fluoride: Fluoride content in ppm (NMT 1000 ppm); Date of
expiry.
2.3.2 Special Labelling Requirements
1. Schedule C1 : Date of manufacture and expiry, Import license number.
2. Schedule G : ”It is dangerous to take this preparation except under medical
supervision’’.
3. Schedule H: Symbol RX conspicuously on the left top corner of the label; ‘’To be sold
by retail on the prescription of a registered medical practitioner only’’; For Narcotic
and Psychotropic drugs, symbol NRX conspicuously on the left top corner of the label
Pharmaceutical Jurisprudence 2.22 Drugs and Cosmetics Act, 1940 …

in red ink and ‘’To be sold by retail on the prescription of a registered medical
practitioner only’’.
4. Schedule X: Symbol XRX in red ink, conspicuously on the left top corner of the label;
‘’To be sold by retail on the prescription of a registered medical practitioner only’’.
5. Preparations for External use: FOR EXTERNAL USE ONLY; eg: lotion, liniment,
ointment, liquid antiseptics.
6. Pharmacopoeial preparations: ‘I.P.’, ‘B.P.’, ‘B.P.C’, ‘U.S.P’, ‘N.F.’ etc.
7. Patents and Proprietary medicines: Quantities of active ingredients.
8. Ophthalmic preparations (solutions, suspensions and ointments): Schedule FF
(i) The statement “use the solution within one month after opening the container”.
(ii) Name and concentration of the preservative used.
(iii) ‘’Not for Injection’’.
(iv) Storage instructions.
(v) Warning:
(a) If irritation persists or increases, discontinue the use and consult physician.
(b) Do not touch the dropper tip or the other dispensing tip to any surface since
this may contaminate the solution.
9. Medicines for Animals: ‘’NOT FOR HUMAN USE, FOR ANIMAL TREATMENT ONLY”;
Symbol depicting the head of a domestic animals.
2.3.3 Specimen Labels
Schedule H drug
Rx ERYTHROMYCIN ESTOLATE TABLETS IP 500 MG

Each uncoated tablet contains:

Erythromycin Estolate IP
equivalent to Erythromycin…….500 mg
Dosage: As directed by the Physician
Store in a cool, dark and dry place

Schedule H Drug
Warning: To be sold by retail on the prescription of a Registered
Medical Practitioner only.

Mfg Lic. No. 2/20 M.R.P not to exceed `……….

Batch No. 2019 inclusive of all taxes
Mfg. Date
Exp. Date

Manufactured by: XYZ Pharmaceuticals, India.

Pharmaceutical Jurisprudence 2.23 Drugs and Cosmetics Act, 1940 …

External use
15 gm

POVIDONE IODINE OINTMENT USP

Composition:
Povidone-Iodine USP……..5% w/w
(0.5% w/w available Iodine)
Water-soluble ointment base q.s.
Store in a cool place

FOR EXTERNAL USE ONLY

Mfg Lic. No. 2/20 M.R.P not to exceed `……….

Batch No. 2019 inclusive of all taxes
Mfg. Date
Exp. Date

Manufactured by: XYZ Pharmaceuticals, India.

Schedule X Drug

XRx PENTOBARBITONE SODIUM INJECTION USP

Each ml contains:
Pentobarbitone Sodium USP ………………50 mg

For Intramuscular Injection only

Dosage: As directed by the Physician

Schedule X Drug
Warning: To be sold by retail on the prescription of a Registered
Medical Practitioner only.

The Injection must be discarded if any precipitate is observed

Mfg Lic. No. 2/20 M.R.P not to exceed `……….

Batch No. 2019 inclusive of all taxes
Mfg. Date
Exp. Date

Manufactured by: XYZ Pharmaceuticals, India.

Pharmaceutical Jurisprudence 2.24 Drugs and Cosmetics Act, 1940 …

Schedule G drug

PHENIRAMINE TABLETS IP

Each uncoated tablet contains:

Pheniramine maleate IP…………………..25 mg
Dosage: 1 tablet 2-3 times daily or as directed by the Physician.
Store protected from light

Caution: It is dangerous to take this preparation except under

medical supervision.

Mfg Lic. No. 2/20 M.R.P not to exceed `……….

Batch No. 2019 inclusive of all taxes
Mfg. Date
Exp. Date

Manufactured by: XYZ Pharmaceuticals, India.

2.4 LIST OF PERMITTED COLOURS

No drug shall contain a colour other than that specified below:
(1) Natural Colours: Annatto, Carotene, Chlorophyll, Cochineal, Curcumin, Red oxide of
iron, Yellow oxide of iron, Titanium dioxide, Black oxide of iron.
(2) Artificial Colours: Caramel, Riboflavin.
(3) Coal Tar Colours: Quinazarine Green SS, Alizarin Cyanine Green F, Fast Green FCF,
Tartrazine, RED (Erythrosine), Eosin YS or Eosine G, Toney Red or Sudan III, Indigo
Carmine, Brilliant Blue FCF, Orange G, Resorcin Brown, Naphthol Blue-Black.
(4) Lakes the aluminium or calcium salts (lakes) of any of the water-soluble colours listed
above.
(5) The label on the container of a drug containing a permitted colour shall indicate the
common name of the colour.
2.5 OFFENCES AND PENALTIES
Same as offences and penalties under sale of drugs.
2.6 ADMINISTRATION OF THE ACT AND RULES
2.6.1 The Drugs Technical Advisory Board (DTAB)
The Central Government constituted this Board, so as to advise the Central Government
and the State Governments on technical matters arising out the administration of this Act
and to carry out the other functions assigned to it by this Act.
The Board shall consist of the following members, namely:
1. Ex-Officio memebers:
(i) The Director General of Health Services, who shall be Chairman.
(ii) The Drugs Controller, India.
Pharmaceutical Jurisprudence 2.25 Drugs and Cosmetics Act, 1940 …

(iii) The Director of the Central Drugs Laboratory, Calcutta.

(iv) The Director of the Central Research Institute, Kasauli.
(v) The Director of the Indian Veterinary Research Institute, Izatnagar.
(vi) The President of the Medical Council of India.
(vii) The President of the Pharmacy Council of India.
(viii) The Director of the Central Drug Research Institute, Lucknow.
2. Nominated members:
(i) Two persons to be nominated by the Central Government from among persons
who are in charge of drugs control in the States.
(ii) One person nominated by the Central Government from the Pharmaceutical
Industry.
(iii) Two persons holding the appointment of Government analyst, nominated by the
Central Government.
3. Elected members:
(i) One person, to be elected by the Executive Committee of the Pharmacy Council
of India, from among teachers in pharmacy or pharmaceutical chemistry or
pharmacognosy on the staff of an Indian university or a college affiliated thereto.
(ii) One person, to be elected by the Executive Committee of the Medical Council of
India, from among teachers in medicine or therapeutics on the staff of an Indian
university or a college affiliated thereto.
(iii) One pharmacologist to be elected by the Governing Body of the Indian Council of
Medical Research.
(iv) One person to be elected by the Central Council of the Indian Medical
Association.
(v) One person to be elected by the Council of the Indian Pharmaceutical
Association.
The nominated and elected members of the Board shall hold office for three years, but
shall be eligible for re-nomination and re-election.
The Central government shall appoint persons to be secretary of the board and other
staffs, if necessary.
Provided that, the person nominated or elected, shall hold office for so long as he holds
the appointment of the office by virtue of which he was nominated or elected to the Board.
The Board may constitute sub-committees and may appoint to such sub-committees for
such periods, not exceeding three years. As it may decide, or temporarily for the
consideration of particular matters, persons who are not members of the Board.
2.6.2 The Central Drugs Laboratory (CDL)
The Central Government established a Central Drugs Laboratory under the control of a
Director to be appointed by the Central Government, to carry out the functions entrusted to
it by this Act or any rules. This was established in Calcutta to carry out the following
functions:
1. To analyse or test, samples of drugs as may be sent to it by the Custom Collectors or
Courts.
Pharmaceutical Jurisprudence 2.26 Drugs and Cosmetics Act, 1940 …

2. Since, CDL is not equipped for testing of all types of products, some other
Government labs and Institutes shall also perform the functions of CDL :
(i) Central Research Institute, Kasauli; carries out the assigned functions in respect
of: Sera, vaccines, toxins, antigens, sterilized surgical sutures and ligatures,
Bacteriophage.
(ii) Pasteur Institute of India, Conoor and Enterovirus Research Centre, Mumbai in
respect of Polio vaccine.
(iii) Indian Veterinary Research Institute, Izatnagar or Mukteshwar in respect of:
antisera, toxoids, vaccines, diagnostic agents for veterinary use.
(iv) Central Indian Pharmacopoeia Laboratory, Ghaziabad in respect of Condoms.
(v) Laboratory of the Serologist and Chemist examiner to the Government of India,
Calcutta in respect of VDRL antigen.
(vi) Department of Biomedical engineering of the Indian Institute of Technology,
New Delhi in respect of Intra Uterine Devices.
(vii) Homeopathic Pharmacopoeia Laboratory, Ghaziabad in respect of Homeopathic
medicines.
3. All samples sent to the laboratories are required to be sent by registered post in a
sealed packet enclosed together with a memorandum in the prescribed form,
addressed to the Director.
4. On receipt of the packet, it must be opened by an authorized officer, in this behalf by
the Director.
5. After test, the results with complete protocols of the tests applied, should be sent to
the sender.
6. Certificates issued by the Laboratory under the rules should be signed by the Director
or any other Central Government authorized officer.
2.6.3 The Drugs Consultative Committee (DCC)
This is also an advisory body constituted by the Central government for the purpose
of advising the Central government the State government and the DTAB, on any matter
tending to secure uniformity throughout India in the administration of this Act.
1. The Drugs Consultative Committee shall consist of two representatives nominated by
the Central Government and one representative nominated by each State
Government.
2. The Drugs Consultative Committee shall meet when required to do so by the Central
Government and shall have power to regulate its own procedure.
2.6.4 Government Drug Analysts
1. The Central and State Government both, by notification in the Official Gazette,
appoint such persons, having the prescribed qualifications, to be Government
Analysts for such areas in the State and in respect of such drugs or classes of drugs
or such cosmetics or classes of cosmetics as may be specified in the notification.
2. A person to be appointed as Government analyst should not have any financial
interest in the import, manufacture or sale of drugs or cosmetics.
Pharmaceutical Jurisprudence 2.27 Drugs and Cosmetics Act, 1940 …

Qualifications of Government Analyst

1. A graduate in medicine or science or pharmacy or pharmaceutical chemistry of a
recognized university, with not less than 5 years post graduate experience in the
testing of drugs; or
2. A post graduate degree in medicine or science or pharmacy or pharmaceutical
chemistry of a recognized university, with not less than 3 years experience; or
3. Associateship Diploma of the institution of chemists with ‘Analysis of Drugs and
Pharmaceuticals’ as one of the subjects with not less than 3 years experience in the
testing of drugs in the laboratory under the control of: A government analyst; or
Head of the institution or testing laboratories approved by the government
authorities.
Duties of Government Analysts:
1. On receipt of a package of a sample from Drug Inspector, the analyst compares the
seals on packages with the specimen impression of the seal received separately and
notes the condition of seals.
2. Thereafter, analyse or test the samples of drugs and cosmetics sent to him by Drug
Inspectors or other persons and to furnish the reports.
3. On completion of analysis, he furnishes the reports of analytical and research work to
the Inspector in Form 13, along with test protocols applied.
Note: If purchaser want to analyse the drug or cosmetic, he has to make an application
for analysis in Form 14-A, with a prescribed fee. The reports of such drugs will be furnished in
Form 14-B, by Government analyst.
2.7 LICENSING AUTHORITIES
1. These are appointed by the Central and State governments for the grant and the
renewal of a licence for the import, manufacture, sale, distribution etc. of any drug or
cosmetic.
2. The licenses once issued, shall remain valid forever, unless suspended or cancelled by
the licensing authority.
3. The licensing authorities are mostly designated as Drug Controller.
4. The Drug Controller, India has recently been notified as the Central License
Approving Authority.
Qualification of a Licensing Authority:
1. He must be a graduate in Pharmacy or Pharmaceutical chemistry or medicine with
specialization in Clinical Pharmacology or Microbiology, from a recognized university.
2. He must be experienced in manufacture or testing of drugs for a minimum period of
5 years.
2.8 CONTROLLING AUTHORITIES
All Drug Inspectors appointed by the Central Government or the State Government act
are under the control of an officer appointed by respective governments referred to as
Controlling authority.
Qualification of a Controlling Authority:
1. He must be a graduate in Pharmacy or Pharmaceutical chemistry or medicine with
specialization in Clinical Pharmacology or Microbiology, from a recognized university.
Pharmaceutical Jurisprudence 2.28 Drugs and Cosmetics Act, 1940 …

2. He must be experienced in manufacture or testing of drugs for a minimum period of

5 years.
The Drug Control Department (DCD): The department is vested with the licenseing of
manufacturing and sales premises of drugs and cosmetics in the state. It primarily strives to
ensure the supply of quality drugs. It comprises 3 wings: Enforcement wing, Educational wing
and Drugs Testing Laboratory (DTL).
The Central Drugs Standard Control Organisation (CDSCO) under Directorate General
of Health Services, Ministry of Health and Family Welfare, Government of India is the
National Regulatory Authority (NRA) of India. Its headquarter is located at FDA Bhawan, Kotla
Road, New Delhi and also has six zonal offices, four sub zonal offices, thirteen Port offices
and seven laboratories spread across the country.
The Drugs and Cosmetics Act, 1940 and rules 1945 have entrusted various responsibilities
to central and state regulators for regulation of drugs and cosmetics.
1. It envisages uniform implementation of the provisions of the Act and Rules made
there under for ensuring the safety, rights and wellbeing of the patients by regulating
the drugs and cosmetics.
2. CDSCO is constantly thriving upon to bring out transparency, accountability and
uniformity in its services in order to ensure safety, efficacy and quality of the medical
product manufactured, imported and distributed in the country.
3. Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs,
Conduct of Clinical Trials, laying down the standards for Drugs, control over the
quality of imported Drugs in the country and co-ordination of the activities of State
Drug Control Organizations by providing expert advice with a view of bring about the
uniformity in the enforcement of the Drugs and Cosmetics Act.
4. Further CDSCO along with state regulators, is jointly responsible for grant of licenses
of certain specialized categories of critical Drugs such as blood and blood products,
I. V. Fluids, Vaccine and Sera.
2.9 DRUG INSPECTORS
The Central Government or a State Government appoints such persons, having the
prescribed qualifications, to be Inspectors.
1. Who have not less than 18 months experience in the manufacture of atleast one of
the substances specified in Schedule C; or
2. Who have not less than 18 months experience in testing of atleast one of the
substances specified in Schedule C in a laboratory approved for this purpose by the
licensing authority; or
3. Who have gained experience of not less than 3 years in the inspection of firms
manufacturing any of the substances specified in Schedule C during the tenure of
their services as Drug Inspectors.
Duties of Drug Inspector:
1. To inspect:
(i) Any premises wherein any drug or cosmetic is being manufactured and the means
employed for standardizing and testing the drug or cosmetic;
(ii) Any premises wherein any drug or cosmetic is being sold, or stocked or exhibited or
offered for sale or distributed;
Pharmaceutical Jurisprudence 2.29 Drugs and Cosmetics Act, 1940 …

2. Take samples of any drug or cosmetic:

(i) Which is being manufactured or being sold or is stocked or exhibited or offered for
sale, or is being distributed;
(ii) From any person who is in the course of conveying, delivering or preparing to deliver
such drug or cosmetic to a purchaser or a consignee;
3. For entering and searching any place, person or vehicle etc. in which he has reason to
believe that an offence has been, or is being, committed; or Stop and search any vehicle,
vessel or other conveyance which, he has reason to believe, is being used for carrying any
drug or cosmetic in respect of an offence been or being committed;
4. For seizure of stocks:
(i) Not to dispose off any stock of such drug or cosmetic for a specified period not
exceeding twenty days, or, unless the alleged offence is such that the defect may be
removed by the possessor of the drug or cosmetic, seize the stock of such drug or
cosmetic and any substance or article by means of which the offence has been or
being committed.
(ii) Examine any record, register, document or any other material object found with any
person, or in any place, vehicle, vessel or other conveyance, and seize the same if he
has reason to believe that it may furnish evidence of the commission of an offence
punishable under this Act or the rules made thereunder;
(iii) Require any person to produce any record, register, or other document relating to the
manufacture for sale or for distribution, stocking, exhibition for sale, offer for sale or
distribution of any drug or cosmetic in respect of which he has reason to believe that
an offence under this Chapter has been, or is being, committed;
The provisions of the Code of Criminal Procedure, 1973, shall, so far may be, apply to any
search or seizure under this Chapter as they apply to any search or seizure made under the
authority of a warrant issued under section 94 of the said Code.
If any person willfully obstructs an Inspector in the exercise of the powers conferred upon
him by or under this Chapter or refuses to produce any record, register or other document
when so required, shall be punishable with imprisonment which may extend to three years,
or with fine, or with both.

EXERCISE
1. Give qualifications, duties and functions of Drug Inspectors.
2. Discuss the general requirements of GMP as per schedule M of the Drugs and
Cosmetics Rules, 1945.
3. Write the qualifications and functions of Government Analyst.
4. Explain in detail, classes of drugs prohibited and permitted to be imported under
license or permission under D and C act.
5. Describe the constitution and functions of DTAB and DCC.
6. Explain in detail about Schedule N.
Pharmaceutical Jurisprudence 2.30 Drugs and Cosmetics Act, 1940 …

BIBLIOGRAPHY
1. K. Dubey, Rajesh Kumar and Pramila Tripathi, Global promotion of herbal medicine:
India’s opportunity - Current Science, 2004, 86(1)
2. N.K. Jain, A Textbook of Forensic Pharmacy, 2014, 49.
3. World Health Organization (2012) Depression.
http://www.who.int/mental_health/management/depression/en/
4. Economic Times (2014) Documentation. http://articles.
economictimes.indiatimes.com/2014-05-06/news/49661672_1_toansa-usfda-indian-
drug-makers
5. Hollister LE and Csernansky JG: Clinical Pharmacology of Psychotherapeutic Drugs.
Churchill Livingstone, New York, Third Edition 1990.
6. Dr. S.P. Agarwal and Dr. Rajesh Khanna, Pharmaceutical Jurisprudence and Ethics,
2017, 37.
7. Vijay Malik, Law Relating Drugs and Cosmetics Act 1940 and Rules 1945, 24th Edition,
2014.
8. Central Drugs Standard Control Organization (2014) Import and Registration
Division, http: //www.cdsco.nic.in/ forms/Show Search Result. aspx? Search=import
9. Drugs and Cosmetic Act (2012) Import of New drug,
http://www.cdsco.nic.in/forms/ShowSearchResult.aspx?Search=clinical%20trials
10. Sumit Kumar, Rishabh Panwar and Upendra Singh, Regulatory Affairs in the Pharmacy
Curriculum, International Journal of Research and Development in Pharmacy and Life
Sciences, 2013, 2(6): 690-698
✱✱✱
 UNIT III

Chapter ... 3
PHARMACY ACT, 1948

♦ LEARNING OBJECTIVES ♦
After completing this chapter, the reader should be able to understand:
The objectives of the Act.
The constitution and functions of Pharmacy council of India.
The constitution and functions of State and Joint state pharmacy councils.
The qualifications for Pharmacist required for first and subsequent registers.
The offences and penalties of the Act.

3.1 INTRODUCTION
Pharmacy Act regulates the profession of pharmacy in India. Since there was no
legislative law and stringent regulations to control the profession of pharmacy in India before
the pre-independence, which was mishandled by persons with no pharmacy knowledge to
compound and prescribe the medicines which were leading to cause great harm to public
health, pharmacy act was framed in the year 1948 to resolve all these issues.
This act also provides regulations for the good conduct of pharmaceutical education,
revising the curriculum to gain academic and practical training for the pharmacists by
framing standard guidelines. This act extends to the whole part of India except Jammu and
Kashmir.
3.2 OBJECTIVES OF THE ACT
The main of objectives of Pharmacy Act, 1948 are:
I. To provide uniform education and training to those persons willing to enter the
pharmacy profession.
II. To maintain control over the persons of the pharmacy profession by registering
them as registered pharmacists in every state and union territories.
3.3 DEFINITIONS
Central Council means the Pharmacy Council of India.
State Council means the State Council of Pharmacy constituted under the Act and
includes the joint state pharmacy councils.
Central Register means the register of Pharmacists maintained by the Central Council
(Pharmacy council of India).
(3.1)
Pharmaceutical Jurisprudence 3.2 Pharmacy Act, 1948

Medical Practitioner means a person holding-medical qualification as provided in the

Indian Medical Degree’s Act or Indian Medical Council Act or a person registered or eligible
for registration in the medical Register of the State or a Dentist or a Veterinarian.
Registered Pharmacist means a person whose name, for the time being, is entered in
the Register of Pharmacists of the state in which he is for time being residing or carrying on
his profession or business of Pharmacy.
3.4 CONSTITUTION OF PHARMACY COUNCIL OF INDIA
The Pharmacy Council of India (PCI) is constituted by the Central Government every five
years.
The first Pharmacy Council of India was constituted in the year, 1949.
The PCI is composed of the following members:
A. Elected members:
(i) Six members, at least one teacher each of Pharmacy, Pharmaceutical Chemistry and
Pharmacognosy elected by UGC from the teaching staff of an Indian University or an
affiliated college granting a degree or diploma in Pharmacy.
(ii) One member, elected by the Medical Council of India from amongst its members.
(iii) One member elected by each State Pharmacy Council who shall be a Registered
Pharmacist.
B. Nominated members:
(i) Six members, nominated by the Central Government, including at least four persons
possessing degree or diploma in Pharmacy and engaged in the practice of Pharmacy
or Pharmaceutical Chemistry.
(ii) One representative each of University Grants Commission and the All India Council
for Technical Education.
(iii) One Registered Pharmacist to represent each State nominated by the State
Government/Union Territory Administration.
C. Ex-officio Members:
(i) The Director General of Health Services.
(ii) The Director of Central Drugs Laboratory.
(iii) The Drugs Controller of India.
The President and Vice-President of the Pharmacy Council are elected by its members
from amongst themselves. They have a term of office of five years. Any member absenting
without sufficient excuse is deemed to have vacated his seat from the Council. A casual
vacancy in the PCI is filled by fresh nomination or election and the person so nominated or
elected holds the office only for the remaining term.
All members of the Council are eligible for re-election or re-nomination. The Council also
appoints:
(i) A Registrar who acts as its Secretary and, if necessary, its treasurer as well,
(ii) Other officers and servants for carrying out its statutory functions.
(iii) The Executive Committee of the PCI consisting of the President (Chairman of the
Committee) and the Vice-President and five other members elected by the Central
Council from amongst its members.
Pharmaceutical Jurisprudence 3.3 Pharmacy Act, 1948

3.4.1 Functions of Pharmacy Council of India

1. To prescribe the minimum standards of education required for qualification as a
Registered Pharmacist.
2. To regulate the minimum educational standards by inspecting the institutions.
3. To recognise the qualification granted outside the territory to which the Pharmacy
Act, 1948 extends, for the purpose of qualifying for registration.
4. To compile and maintain a Central Register for Pharmacist, containing names of all
Registered persons.
5. Any other function required for the furtherance of objectives of the Pharmacy Act,
1948.
3.4.2 Education Regulations for Pharmacy
The Pharmacy Council of India has laid down certain minimum standards of education
required as Pharmacist. These standards are known as Education Regulations and prescribe:
(i) Minimum educational qualification required for admission to the course of
Pharmacy.
(ii) Duration of course of study and training.
(iii) Nature and period of practical training to be undertaken after the completion of
regular course.
(iv) Subjects of examination and the standards to be attained therein for qualification.
(v) Minimum facilities required to be provided by an institution for the conduct of
course of examination and practical training.
(vi) Conditions to be fulfilled by the authorities holding approved examinations.
Main Features of Education Regulations – 91:
According to ER-91, a candidate has to undergo practical training after having appeared
in Diploma in Pharmacy Part II examination in one or more of the following institutions:
(i) Government hospitals/dispensaries.
(ii) Other hospitals dispensaries recognised by the PCI.
(iii) Licensed pharmacy, chemists and druggists shops.
(iv) Licensed drug manufacturing units.
Practical training should be for a minimum of 500 hours spread over a period of not less
than three months out of which not less than 250 hours must be devoted to actual
dispensing of preparations. In the course of practical training, the trainee should have
exposure to:
(i) Working knowledge of records required by various acts covering the profession of
Pharmacy.
(ii) Practical experience in:
(a) The manipulation of pharmaceutical apparatus in common use.
(b) The reading, translation, and copying of prescriptions including checking of
dose.
(c) The dispensing of prescriptions illustrating the commoner methods of
administering medications.
(d) The storage of drugs and medical preparations.
Pharmaceutical Jurisprudence 3.4 Pharmacy Act, 1948

These Education Regulations are approved by the central government. However, before
submitting ER or any amendment to the central government for approval, the Pharmacy
Council of India sends copies to all State Governments and takes into consideration the
comments of any state government received within 3 months from the date of furnishing
draft ER. The ER is notified in the official gazette by the central government.
Approval of Institution Providing a Course of Study and Examination for the Pharmacy
Profession:
Any institute or organization providing a course of study and examination in Pharmacy
has to follow the below procedure for the PCI approval.
1. Application by the institute: The institute proposing to conduct the pharmacy
course has to apply to the PCI.
2. Inspection: After receiving the application, PCI deputes its inspectors to visit the
institution and inspect weather the institution has the prescribed facilities for
imparting training or holding examinations in accordance with the ER or not. The
inspectors may also attend an examination without interfering their conduct to
inspect the standards. After the inspection, inspectors report to the PCI about the
facilities available in the institute for the course of study and examination.
3. Approval: If the PCI is satisfied with the report of inspectors, it may accord approval
and the said course or examination will be claimed to be approved for qualifying
registration as Pharmacist.
4. Declaration: Once the institute has been approved by PCI, such approval will be
published in Gazette.
Withdrawal of Approval:
If the executive committee reports to the PCI that an approved course of study or an
approved examination does not continue to be in conformity with the Education Regulations,
the PCI gives notice of its intention to withdraw its approval. The said institution should make
a representation within the 3 months to PCI through state government and PCI then decides
to either to continue the approval or to withdraw.
Approval of Qualification Granted Outside India:
The PCI may approve any qualification in Pharmacy granted by an authority outside India,
to be approved qualification for the purpose of qualifying for registration as a pharmacist
under this act, if a sufficient guarantee of the requisite skill and knowledge affords. This is
applicable to Indian citizens.
Other countries' citizens holding qualification granted there, shall be eligible for
registration in this country when an Indian national holding the same qualification by law
allowed to enter and practice the profession of pharmacy in this country.
Registration of Pharmacists:
The PCI is required to maintain a Central Register of pharmacists which contains the
names of all persons for time being entered in the registers of different State councils of
India. Each state pharmacy council has to supply five copies of its register to the PCI as soon
as after 1st April every year. After receiving the registration details of the person in the
register for a State, Registrar of PCI enters the name of such persons in the central register.
The central register is published in Gazette from time to time.
Pharmaceutical Jurisprudence 3.5 Pharmacy Act, 1948

3.5 STATE AND JOINT STATE PHARMACY COUNCILS

Each state of India can constitute state pharmacy council under the provision of
Pharmacy Act by their respective State Governments. Joint state pharmacy councils can also
be constituted where two or more states agree to serve the needs of the other participating
states.
The composition of State and Joint State Pharmacy Councils is as follows:
State Pharmacy Council Joint State Pharmacy Council
Elected Members: Elected Members:
1. Six members elected amongst 1. Six members elected amongst
themselves by Registered Pharmacists of themselves by Registered Pharmacists
the State. of each participating State.
2. One member elected by the Medical 2. One member elected by the Medical
Council of the State from amongst its Council of the State from amongst its
members. members.
Nominated Members: Nominated Members:
1. Five members nominated by the State 1. Two to four members nominated by
Government, of whom, at least three each participating State Government,
should possess a degree or diploma in of whom, more than half should
pharmacy or half should possess a possess a degree or diploma in
degree or diploma in pharmacy, pharmacy, pharmaceutical chemistry or
pharmaceutical chemistry or be be Registered pharmacists.
Registered pharmacists.
Ex-officio Members: Ex-officio Members:
1. Chief administrative medical officer of the 1. Chief administrative medical officer of
state. each of the participating State.
2. Officer-in-charge of Drugs Control 2. Officer-in-charge of Drugs Control
Administration of the State. Administration of each participating
3. Government Analyst of the State or State.
where there is more than one Analyst, 3. Government Analyst of each
such one may be appointed by the State participating State.
Government.
The President and Vice-President of the State Councils are elected by the members from
amongst themselves. Both the nominated and elected members of the Council can hold
office for a term of five years. Any member absenting without sufficient excuse is deemed to
have vacated his seat from the council. A casual vacancy in the Council is usually filled by
fresh nomination or election. All members of the Council are eligible for re-election or re-
nomination. Like the PCI, State and Joint State Pharmacy Councils also usually appoint a
Registrar (who may also act as its Secretary and Treasurer) and other necessary officers and
staff as may be required to carry out its functions under the Pharmacy Act. An Executive
Committee is also constituted in similar way to that of PCI and its function is to furnish
necessary information and annual report to the PCI.
Pharmaceutical Jurisprudence 3.6 Pharmacy Act, 1948

3.5.1 Functions of State Pharmacy Councils and Joint State Pharmacy

Councils
I. Inspection by State Councils:
The State and Joint State Pharmacy Councils with permission from the respective State
Governments may appoint a sufficient number of Inspectors having prescribed qualification:
(i) To inspect any premises where drugs are compounded or dispensed.
(ii) To enquire whether the dispensing or compounding of drugs is done by registered
pharmacists or not.
(iii) To investigate any complaint made in writing regarding contravention of the Act.
(iv) To institute prosecution under the direction of the Executive Committee of the State.
(v) To exercise such other powers as may be necessary for certain provisions of the Act.
II. Registration of Pharmacists in the First and Subsequent Registers:
The Pharmacy Act, 1948 provides for the registration of Pharmacists in all the states of
India.
The first Register of Pharmacists in a State is required to be prepared by the State
government. State Pharmacy Councils are responsible for the maintenance of the first and
subsequent Registers where pharmacists’ names are to be entered. Every year, before the
end of June, State councils are required to pay Central council, a sum equivalent to one
fourth of fees prescribed by the PCI during the period of 12 months before the end of 31st
March. The Register of Pharmacists includes the following particulars:
(i) Full name and residential address of the registered person.
(ii) The Date of his first entry in the Register.
(ii) Qualification of the person required for registration.
(iv) Professional address of the person and in the case of employed persons, the details
of the employer.
(v) Such other particulars as may be prescribed.
First Register:
For preparing the first Register, the State Government constitutes a Registration
Tribunal comprising of three persons and a Registrar who also acts as its secretary. The State
Government then appoints a date before which all applications for registration, accompanied
by the prescribed fee should reach the Registration Tribunal. On receipt of the applications,
the tribunal then examines all the applications upto the appointed date and when satisfied
that an applicant is duly qualified, directs his or her name to be entered into the Register.
The first Register is published by the State Government. Any person who is dissatisfied
with the decision of the Tribunal can appeal to the authority appointed by the Government
within 60 days of such publication in this behalf. The decision of the State Government is
considered to be final and the Tribunal has to amend the Register in accordance with the
directions of the Government. Upon the constitution of the State Council, the Register is
handed over into its custody.
Qualifications for Entry of a Person into the First Register:
A person whose name has to be entered into the First Register should have the following
qualifications:
Pharmaceutical Jurisprudence 3.7 Pharmacy Act, 1948

(i) Should have attained the age of 18 years.

(ii) Should pay the prescribed fee to the state council.
(iii) Should be a resident of the State or should carry out his business or profession of
pharmacy in the State.
(iv) Should have the following qualifications.
(a) A degree or diploma in Pharmacy or Pharmaceutical Chemistry or a Chemist and
Druggist Diploma of an Indian University or a State Government or possess any
other qualification granted outside the India which is recognised as adequate
for registration, or
(b) A degree of an Indian university other than a degree or diploma in Pharmacy or
Pharmaceutical chemistry and engaged in dispensing and compounding of
drugs in a hospital or dispensary or any other place where drugs are regularly
dispensed on the prescription of a Registered Medical Practitioner for a time
period of not less than 3 years, or
(c) Have passed an examination recognized as adequate by the State Government
for compounders and dispensers, or
(d) Have an experience of not less than five years in dispensing and compounding
of drugs in a hospital or dispensary or any other place where drugs are
regularly dispensed on the prescription of a Registered Medical Practitioner,
prior to the date notified by the State Government for receipt of applications for
entry of names on the first Register.
Subsequent Registers:
After the preparation of the first Register and before the Education Regulations have
taken effect in a state, a person desirous of having his name registered in the Subsequent
Register has to qualify for the following particulars:
(i) Should be at least 18 years of age.
(ii) Should have paid the prescribed fee.
(ii) Should be a resident of the State or should carry out his business or profession of
pharmacy in the State.
(iv) Should fulfill the following requirements:
(a) Requirements as prescribed for registration and where no such requirements
have been prescribed, possess the qualifications which would have entitled him
to have his name registered on the first Register and is at least matriculate, or
(b) Is a Registered Pharmacist in another State, or
(c) Possess a qualification granted outside India which is recognized as adequate
for registration and is at least matriculate qualification required after Education
Regulations have taken effect.
Special Provisions for Registration of Certain Persons:
The Pharmacy (Amendment) Act of 1959 made some special provisions for certain classes
of persons affected by the partition of the country in 1947. These provisons are applicable to
those who migrated to India or resisted in a place which became Indian territory. These
provisons became effective after years of commencement of Pharmacy (Amendement) Act,
1959 which made special provisons for the following persons:
Pharmaceutical Jurisprudence 3.8 Pharmacy Act, 1948

1. Persons holding a degree or diploma in pharmacy, pharmaceutical chemistry or a

chemist and druggist diploma of an Indian University or a State government or have
passed an examination recognised by the state government as adequate for
componders and dispensers and who were eligible for registration between closing
of the First Register and the date when Education Regulation came into effect.
2. Persons approved as Qualified Persons before 31st December 1969 for
compounding and dispensing of medicines under the Drugs and Cosmetics Act,
1940 and Rules.
3. Displaced persons from Bangladesh who left Bangladesh after 14th April, 1957 but
before 25th March, 1971 and Repatriates from Burma, Srilanka, Uganda or any other
country who left or were displaced from such country between 14th April, 1957 and
25th March, 1971 and were carrying out the business or profession of pharmacy as
the principle means of their livelihood for a total period of five years prior to the
date of application.
4. Citizens of India who had been engaged in the business or profession of pharmacy
abroad and satisfied the conditions for registration in the first register of the
respective Indian State Councils.
5. Persons who have been engaged in the dispensing of drugs in a hospital or
dispensary or another place where the drugs are dispensed regularly on
prescriptions of Registered Medical Practioners for a period of five years prior to the
date appointed.
Removal of Names from the Register:
The names of the registered persons may be removed from the register on the following
reasons:
1. If his name has been entered into the Register by error, misrepresentation or
suppression of facts.
2. If he has been convicted of an offence in any professional respect which in the
opinion of Executive Committee renders him unfit to be on the Register of
Pharmacists.
3. If a person employed under him in connection with any business of pharmacy has
been convicted of any offence or has been found guilty of any infamous conduct,
such that if he himself was a Registered Pharmacist, his name would have been
removed from the Register.
However, under this section, action against the Pharmacist can only be taken if it is
proved that:
(a) The offence or infamous conduct was instigated or connived at by the Registered
Pharmacist, or
(b) The Registered Pharmacist himself has been guilty of such an offence during the
period of 12 months preceding the offence.
(c) Any person employed by the Pharmacist for purpose of the business of pharmacy
has been guilty of similar offence during the preceding 12 months and the
Pharmaceutical Jurisprudence 3.9 Pharmacy Act, 1948

Registered Pharmacist had, or reasonably ought to have had, knowledge of such

previous offence.
(d) The offence or infamous conduct continued over a period, the registered pharmacist
had or reasonably ought to have, knowledge of continuing the offence or infamous
conduct.
(e) The act is an offence under the Drugs and Cosmetics Act, 1940 and the Pharmacist
had not used his intelligence to ensure that the provisions of the Act were being
complied at his place of business and by persons employed by him or by persons
under his control.
An order of removal of names of persons from the register may direct that the person
whose name is removed shall not be eligible for registration either permanently or for time
being under this act. The order of Executive Committee is subject to confirmation by the
State Pharmacy Council and does not take effect until after three months from the date of
such confirmation.
Any person aggrieved by the order for removal of his name from the register may appeal
within 30 days from the communication to him of confirmation of the order by the State
Council and the State Government decision is final. A person whose name has been removed
from the register has to surrender his registration certificate to State Pharmacy Council
Registrar and the name so removed is published in the Gazette.
Printing of Registers:
Subsequent to the commencement of the Pharmacy (Amendment) Act, 1959, as soon as
may be after the 1st April, every year, the registrars of the State Council were required to print
the registers as they stood on that date. They are also required to print as soon as may after
the 1st April in each year, copies of the annual supplement to register, showing all additions
to, and other amendments, in the said register. The registrar should bring up-to-date the
respective registers, three months before ordinary elections of the State Council are held and
print copies of the register. Such copies should be made available to persons applying for the
same, on payment of the prescribed charge. Such copies are the evidence that on the date
referred to in the register of annual supplement, the persons, whose names are entered
therein, were registered pharmacists.
3.5.2 Offences and Penalties
The offences and penalties of the Pharmacy Act are as follows;
Falsely claiming to be registered pharmacist: Any person who falsely claims to be a
registered pharmacists and/or uses in connection with his name or title any words or letters
to show that his name has been entered in the register of Pharmacist, such person is
punishable on first conviction with a fine extending up to ` 500 and a fine up to ` 1000 and
imprisonment for up to 6 months on second or subsequent conviction. The use of words,
Pharmacist, Chemist, Druggist, Pharmacist, Dispenser, Dispensing Chemist or any
combination of such words shall be deemed to suggest that a person is a Registered Person.
If a person is a Registered Pharmacist in another state and at the time of making such
acclaim, has filed an application for registration in the state, he shall not be deemed to be
guilty of the offence.
Pharmaceutical Jurisprudence 3.10 Pharmacy Act, 1948

Dispensing by Unregistered Persons:

After the date notified in this behalf, by the State Government, no person other than a
Registered Pharmacist can dispense, mix or compound drugs on the prescription of a
medical practitioner. This, however, does not apply to dispense of medicines by a Medical
Practitioner to his own patients, or with the permission of the State Government to the
patients of other medical practitioner.
Dispensing by unregistered persons is punishable with imprisonment of upto six months
or a fine of up to ` 1000 or both. Cognizance of this offence can be taken only on the
complaints by the state government or by an officer authorized in this behalf or by the order
of the Executive Committee of the State Pharmacy Council.
Failing to Surrender Certificate of Registration:
If any person, whose name has been removed for the time being from the Regtister, fails
to surrender his certificate of registration without sufficient reason is punishable with a fine
up to ` 50. Cognizance of this offence shall not be taken except by an order of the Executive
Committee of the State Pharmacy Council.
Penalty for Obstructing Inspectors:
Any person willfully obstructing Inspector of State Pharmacy Council shall be liable to
imprisonment of up to 6 months or a fine of up to ` 1000 or both.

EXERCISE
1. Discuss the constitution and functions of pharmacy council of India. Add a note on
educational regulations.
2. Write the objectives of the Pharmacy Act.
3. Explain the constitution and functions of state and joint state pharmacy councils.
4. What is first register? Give the qualifications required for the entry in to the first
register.
5. Enlist the qualifications required for the entry of persons in subsequent register.
6. Describe the procedure notified in the Pharmacy Act, 1948 for the removal of names
from the register of pharmacists.
7. What are the special provisions applicable to the certain persons as per the
Pharmacy Act, 1948.
8. Discuss the offences and penalties of the Pharmacy Act, 1948.

BIBLIOGRAPHY
1. Agarwal SP and Khanna R., Pharmaceutical Jurisprudence and Ethics, 5th ed, reprint.
New Delhi: Birla Publications Pvt. Ltd; 2005.
2. Jain NK, A text book of Forensic Pharmacy, 8th ed, reprint. Delhi: Vallabh Prakashan;
2014.
3. Mithal BM, A Text Book of Forensic Pharmacy, 10th ed, reprint. Delhi: Vallabh
Prakashan; 1998.
✱✱✱
Chapter ... 4
MEDICINAL AND TOILET
PREPARATIONS (EXCISE DUTIES) ACT,
1955

♦ LEARNING OBJECTIVES ♦
After completing this chapter, the reader should be able to understand:
The objectives of the Act.
The procedure of getting license for manufacturing medicinal and toilet preparations.
The bonded and non-bonded manufacturing process of alcoholic preparations.
The export process of alcoholic preparations.
The offences and penalties of the Act.

4.1 INTRODUCTION
Alcohol has excellent solvent properties apart from its preservative mechanism and hence
it has found a very important role in the manufacturing of drugs and medicines. Drinking
alcohol is an abuse whereas its usage in toilet preparations may be considered as a luxury.
For this reason, alcohol, which is used either for drinking or for the manufacture of toilet
preparations such as perfumes, is subject to a much higher rate of excise duty than that used
for the manufacture of medicinal preparations which cannot be used as ordinary alcoholic
beverages. Prior to the enactment of this act, each state in India had an Excise manual and a
set of rules of its own. Thus, differences existed in the rates of excise duty for the same item
in different states, leading to large scale inter-state smuggling of such preparations. The Act
was passed mainly to curb this evil and repealed the laws in force in any state prior to the
commencement of this Act. However, any state rules not inconsistent with this Act are still
valid and have the same force as if they have been made by an authority in this behalf under
this Act.
The Medicinal and Toilet preparations Act was passed in the year 1955 and the Rules
were passed in 1956. The Act extends to the whole of India and came into force on 1st April
1957.
4.2 OBJECTIVES OF THE ACT
This Act was passed with the following objectives:
(i) To provide the collection of levy and duties of excise on medicinal and toilet
preparations containing alcohol, narcotic drugs or narcotics.

(4.1)
Pharmaceutical Jurisprudence 4.2 Medicinal and Toilet Preparations …

(ii) To provide for uniformity in the rules and rates of Excise duties leviable on such
preparations throughout the country.
4.3 DEFINITIONS
Alcohol means ethyl alcohol of any strength and purity having the chemical composition
C2H5OH.
Absolute alcohol means alcohol conforming to the British Pharmacopoeial specifications
for dehydrated alcohol.
Dutiable goods means the medicinal and toilet preparations specified in the Schedule as
being subject to the duties of excise levied under the Act.
Medicinal preparation includes all drugs which are a remedy or prescription prepared
for internal or external use of human being or animals and all substances intended to be
used for or in the treatment, mitigation or prevention of disease in human beings or animals.
Toilet preparation means any preparation which is intended for use in the toilet of the
human or in perfuming apparel of any description, or any substance intended to cleanse,
improve or alter complexion, hair, skin or teeth, and includes deodorants and perfumes.
Bonded manufactory means the premises approved and licensed for the manufacture
and storage of medicinal and toilet preparations containing alcohol, opium, Indian hemp or
any other narcotic drug or narcotics on which duty has not been paid.
Non-bonded manufactory means the premises approved and licensed for the
manufacture and storage of medicinal and toilet preparations containing alcohol, opium,
Indian hemp or any other narcotic drug or narcotics on which duty has been paid.
Patent or Proprietary medicines means any medicinal preparation which bears either
on itself or on its container or both, a name which is not specified in a monograph in a
Pharmacopoeia, formulary or other publications notified in this behalf by the Central
Government in the Official Gazette, or which is a brand name or any other mark such as a
symbol, monogram, label, signature or invented words or any writing which is used in
relation to that medicinal preparation for the purpose of indicating or so as to indicate a
connection in the course of trade between the preparation and some person having the right
either as proprietor or otherwise to use the name or mark with or without any indication of
the identity of that person.
Denatured alcohol or Denatured spirit means alcohol of any strength which has been
made unfit for human consumption by the addition of substances approved by the Central
Government or by the State Government with approval of the Central Government.
Rectified spirit means plain denatured alcohol of strength not less than 50.0° over proof
and includes absolute alcohol.
London proof spirit means that mixture of ethyl alcohol and distilled water which at the
temperature of 51°F weighs exactly 12/13th parts of an equal measure of distilled water at the
same temperature.
Restricted preparation means every medicinal and toilet preparation specified in the
Schedules and includes every preparation declared by the Central Government as restricted
preparation.
Unrestricted preparation means any medicinal or toilet preparation containing alcohol
but other than restricted preparation or a spurious preparation.
Pharmaceutical Jurisprudence 4.3 Medicinal and Toilet Preparations …

4.4 LICENSING PROCEDURE

Manufacturing of alcoholic and narcotic preparations can only be undertaken under the
authority of a license granted for the purpose and such a license is issued only if the requisite
license for manufacture of drugs under the Drugs and Cosmetics Act and Rules has been first
obtained. Application for the license or for its renewal is to be made to Licensing authority
who is the excise in the case of a bonded manufactory or ware house and in other cases,
such officer as the State government may authorize in this behalf. A separate application is to
be made if more than one kind of license is desired. Where the applicant has more than one
place of business, he should obtain a separate license in respect of each such place of
business. The application for the license should be submitted in the prescribed form
accompanied by the prescribed fee, at least two months before the proposed date of
commencement of the manufacture.
The following particulars are required to be submitted in the application for obtaining a
license to manufacture dutiable goods in or outside bond:
1. Name and address of the applicant and place and site on which the manufactory is
situated or to be constructed. If the applicant is a firm, the name, and address of
every partner of the firm, and if it is a company, its registered name, and address,
and the names and addresses of its directors, managers, and managing agents.
2. The amount of capital proposed to be invested in the venture.
3. Approximate date from which the applicant desires to commence the manufactory
and the statement whether the bonded laboratory will require the services of a
whole-time or part time excise officer and whether quarters for the excise staff will
be provided within the manufactory.
4. The number and full description of vatts, still and other permanent apparatus and
the machinery which the applicant wishes to get up together with the maximum
quantity of alcohol and alcohol content in the finished preparations and the
maximum quantities by weight of opium, Indian hemp or other narcotic drugs or
narcotic and their contents in finished and unfinished preparations.
5. The site and elevation plans of the manufactory/building and also similar plans for
the quarter of the Excise Officer together with relevant records.
6. The amount in cash or Government Promissory Notes which the applicant is
prepared to furnish for the due performance of the conditions on which the license
may be granted.
7. The kind and number of each license under the Drugs and Cosmetics Act held by
applicant.
8. A list of all preparations which the applicant proposes to manufacture and/or those
manufactured during the preceding year showing the percentage or proportion of
alcohol in alcoholic preparations or opium, Indian hemp or another narcotic drug in
terms of weight in proportion containing those substances, quoting the
pharmacopoeia under which such preparations were proposed to be manufactured.
Pharmaceutical Jurisprudence 4.4 Medicinal and Toilet Preparations …

On receipt of the application, the Licensing Authority may enquire into the following:
(i) The qualifications and previous experience of technical personnel engaged in the
manufacturing operations.
(ii) The equipment of the bonded and non-bonded laboratory.
(iii) The soundness of the applicant's financial position.
(iv) Suitability of the proposed building for the establishment of the manufacturing unit.
The license cannot be sold or transferred. It should be exhibited in a conspicuous part of
the licensed premises. Where a licensee sells or transfers his business to another person, the
purchaser or the transferee has to obtain a fresh license but for the residue of the period
covered by the license, it is issued free of cost. A licensee can enter into partnership after
obtaining the prior sanction of the licensing authority and his license is then suitably
amended. If a partnership is dissolved, every partner is required to send a report of
dissolution to the licensing authority within ten days. If a licensee desires to transfer his
business to new premises he can do so by informing the licensing authority at least fifteen
days in advance, specifying the address of the premises, and getting his license suitably
amended.
A license can be revoked, or suspended by the licensing authority if the licensee or any
other in his employment is found to have committed a breach of the prescribed conditions
or any of provisions of the act or rules, or has been convicted of an offence; after giving him
a reasonable opportunity of showing cause against the action proposed to be taken. The
license remains valid for a period of one year and should be renewed thereafter. The
application for renewal should be submitted at least one month before the commencement
of the year to which it relates. The licensee also provides a Visit Book paged and stamped by
any officer empowered by the Excise commissioner in this behalf, in which the visiting
officers may record any remarks when inspecting the licensed premises. On termination of
the period of the license, the licensee has to deliver the Visit Book, the account and the
license to such officer as directed by the licensing authority. All invoices, cash memoranda,
permits and other documents relating to the consignments received and dealt with licensee
are to be preserved for a year after the year to which they relate.
4.5 MANUFACTURE
Manufacture of alcoholic and other narcotic drugs can be undertaken only under the
authority a license granted for the purpose. Such license is issued only when the requisite
license for the manufacture of drugs under the Drugs and Cosmetics Act has been first
obtained. The license cannot be transferred or sold and has to be exhibited in a conspicuous
part of the licensed premises. Manufacture of medicinal and toilet preparations containing
alcohol is permitted both 'in bond' as well as 'outside bond.
4.5.1 Manufacture in Bond
Preparations are deemed to be manufactured in the bond when they are manufactured in
the premises, that are licensed or approved for this purpose and on which excise duty is not
paid until the finished products are removed from the licensed premises. Rectified spirit is
issued for the purpose only if manufacturer enters into a bond with sufficient security
towards due payment of the duty.
Pharmaceutical Jurisprudence 4.5 Medicinal and Toilet Preparations …

Bonded Laboratory:
A bonded laboratory should have the following provisions:
1. A spirit store unless the laboratory is attached to a distillery or a spirit warehouse.
2. A large room for the manufacture of medicinal preparations and separate
arrangement for the manufacture of toilet preparations.
3. There should be one or more separate rooms for the storage of finished medicinal or
toilet preparations.
4. Accommodation with necessary furniture for the officer-in-charge of the bonded
laboratory near its entrance.
5. Malleable iron rods not less than 1.9 cm in thickness, set not more than 10 cm apart,
embodied in brick work to a depth of at least 5 cm and covered on the inside with
strong wire netting or expanded metal of a mesh not more than 2.5 cm in diameter
or length, in every window of the bonded laboratory.
6. A board outside every room bearing the name and a serial number of the room.
7. All pipes from sinks inside the laboratory, connected with the general drainage
system of the premises.
8. Provisions for cutting off the gas and electric supply to the laboratory at the end of
the day's work.
There should be only one entrance to the laboratory and only one door for each of its
compartments. The laboratory can be opened only in the presence of the Excise officer-in-
charge and during his absence, all the doors should be secured with excise ticket locks.
Addition or alteration to the permanent fixture in the premises can be made only with the
previous permission of the Excise Commissioner. The permanent vessels for the storage of
alcohol, narcotic drugs and narcotics received under bond and all the finished products on
which duty has not been paid should be secured with excise ticket locks. All vessels intended
to hold alcohol and liquid preparations should bear a distinctive serial number and their full
capacity distinctly and indelibly marked on them.
Manufacture of Alcoholic Preparations in Bond:
1. Procurement of Spirit from a Distillery or Spirit Warehouse:
Rectified spirit required for the manufacture of medicinal and toilet preparations can be
obtained on an indent counter signed by the officer-in-charge of the laboratory, from any
approved distillery or spirit warehouse either situated in the same State or in another Stare.
The officer of the distillery warehouse, on receipt of the duplicate copy of the indent, shall
issue the spirit in duly sealed containers and send advice of the consignment to the Excise
officer-in-charge of the bonded laboratory.
2. Verification and Storage of Spirit Received:
Consignments of spirit received at the laboratory have to be verified in volume and
strength by the Excise officer and then stored in the Spirit Store from where it can be issued
from time to time to the manufacturer, according to his requisition.
3. Issue of Spirit from the Spirit Store for Manufacture:
Calculated quantities of spirit can be obtained by the manufacturer on a requisition to
the officer in-charge who shall then issue the same from the Spirit Store. The spirit so issued
Pharmaceutical Jurisprudence 4.6 Medicinal and Toilet Preparations …

has to be immediately mixed with other ingredients of the preparation in the presence of the
officer-in-charge. The percolators or other vessels charged with the spirit should be labeled
with the following particulars:
(a) Name and Batch number of preparation.
(b) Description and quantity of alcohol put in it.
(c) Date of removal of preparation and the quantity of such preparation removed.
As soon as the manufacture of preparation has been completed, it should be removed to
the finished goods store, measured and stored in the vessels provided for the purpose.
Details of the preparation should also be entered in a register and it should be given a Batch
number. The Excise officer-in-charge may permit the manufacturer to take a sample of not
more than 250 ml for analysis purpose, free of duty. A separate account must be maintained
by the manufacturer regarding the number of samples used by him for analysis and any
amount left over after analysis should be mixed with the main bulk of the batch.
4. Storage of Finished Product:
All finished preparations should be stored in bulk in jars or bottles, each containing not
less than 2.25 litres of the preparation. Every container should be labeled with the name of
the preparation of its batch number, strength, date of storage and the actual content in bulk
litres. The containers should be so arranged in suitable racks so as to allow ready
identification of each batch. A record of all deficiencies in bulk content of finished
preparations should be kept by the officer-in-charge and Excise Commissioner quarterly. If
the Excise Commissioner is satisfied that the deficiency reported was due to some
unavoidable reasons, he may remit the duty payable. Otherwise, such loss is subject to levy of
duty at a penal rate which shall not be more than double the prescribed rates.
5. Issue of Alcoholic Preparations from Bonded Laboratories:
Alcoholic preparations from a bonded laboratory can be taken out by the manufacturer
by making an application to the officer-in-charge and after payment of the excise duty. Duty
is payable even on Physician's free samples. However, preparations issued to a bonded
warehouse or for export to a place outside India or to institutions authorized to receive duty
free preparations may be issued without the payment of duty.
Disposal of Substandard Preparations:
A finished medicinal or toilet preparation if suspected to have deteriorated in quality may
be destroyed by the manufacturer with the permission of the Excise Commissioner. The
Excise Commissioner may also allow the manufacturer to reprocess a sub-standard
preparation. The Excise Commissioner shall waive the duty on the alcoholic content of the
preparation so destroyed, if he is satisfied that the deterioration of the preparation or its
improper manufacture was due to reasons beyond the control of the manufacturer.
Disposal of Recovered Alcohol:
Alcohol recovered in the course of production of a medicinal or toilet preparation may be
for subsequent production of the same preparation, provided, such alcohol is collected and
accounted separately. Where the alcohol recovered from a preparation liable to duty at the
lower rate is sought to be used in the manufacture of a preparation subject to a higher rate
of duty, the duty on the preparation so manufactured shall be collected after determining the
Pharmaceutical Jurisprudence 4.7 Medicinal and Toilet Preparations …

spirit strength of the preparation. An account of recovered alcohol shall be maintained by the
officer-in-charge in the prescribed form. Recovered alcohol unfit for the consumption shall
be destroyed by the manufacturer in the presence of officer-in-charge. No rebate of duty
shall however, be allowed on recovered alcohol so destroyed.
Wastage of Spirit during Manufacture:
The permissible percentage of wastage of alcohol during the manufacture of a particular
medicinal or toilet preparation is fixed by the State Government from time to time. Any
wastage exceeding the permissible limit and not properly accounted for shall be charged
with the duty together with such penalty not exceeding the duty leviable thereon as the
Excise Commissioner may deem fit.
Remission of Duty In Case of Loss Due to Accident:
In case of any accidental loss of alcohol in bonded manufactory (except on account of
theft), the Excise commissioner may remit the duty on the alcohol so lost, if he is advised by
the Excise Officer in-charge of the laboratory that the loss was beyond the control of the
manufacturer.
4.5.2 Manufacture Outside Bond
Preparations are deemed to be manufactured outside bond when they are manufactured
in a premise, licensed or approved for this purpose and where duty paid spirit is used for the
preparation. The manufacture and sale in a non-bonded laboratory have to be conducted
between sunrise and sunset on days and hours fixed for this purpose by the Excise
Commissioner.
1. Receiving Duty Paid Spirit:
Rectified spirit can be obtained from any distillery or spirit warehouse on an indent
prepared in triplicate. The original copy is sent to the distiller or spirit warehouse keeper, the
duplicate is sent to the officer in-charge of the distillery or spirit warehouse and triplicate is
retained by the licensee. The duty should be paid to the Government Treasury and a challan
in token of such payment should be enclosed along with the duplicate copy of the indent
being sent to the officer-in charge of the distillery or spirit warehouse. The treasury officer
sends advice to the officer-in-charge of the distillery or the spirit warehouse who shall issue
the spirit together with a permit covering the issue. The spirit so brought into the non-
bonded manufactory has to be immediately transferred to the spirit store and the necessary
accounts written up in the prescribed register. The manufacturer cannot sell or transfer the
rectified spirit obtained by him. In any case, the quantity of rectified spirit in the possession
of the manufacturer should not exceed the limit fixed by the licensing authority.
2. Manufacture, Storage, and Sale:
The manufacture, storage, and sale should be carried out in the licensed premises only.
Each preparation should be registered and bear a distinctive batch number. All finished
preparations should be transferred from the laboratory to the 'finished store' and be so
arranged that the checking of stock of every batch of preparation from the register is
facilitated. Preparations stored in bulk should be measured into the storage vessel to the
nearest fluid ounce and sealed. The quantities taken out from time to time should be entered
in the stock card maintained for the purpose.
Pharmaceutical Jurisprudence 4.8 Medicinal and Toilet Preparations …

3. Sampling:
Without previous notice to the manufacturer, the excise Sam officer shall take samples of
not less than 10% and not more than 15% of the total number of preparations from the
finished stocks at least once every month. These samples are forwarded to the chemical
examiner for the verification of alcohol contents thereof. If the report of the chemic examiner
differs by more than 3° proof strength as declared by the manufacturer, the manufacturer is
liable to a penalty at the rate of 10 times the difference in duty on the quantity so
manufactured but not exceeding ` 2000. The frequent occurrence of such offence shall be
ground for the cancelation of the license held by the manufacturer. All samples are to be
taken by the excise officer personally and in the presence of the manufacturer or his
authorized agent. Every sample (8 fluid ounces or as fixed by the Excise Commissioner)
should be taken in duplicate and the cork of each bottle should be fixed with an officer's
personal seal. The label of the bottle should be signed by the officer taking the sample.
The manufacturer can also affix his seal and sign the labels. Duplicate samples are to be
preserved carefully under lock and key and returned promptly to the manufacturer when
needed no more. The manufacturer is not entitled to any compensation for the samples
taken for analysis.
4. Returns:
The manufacturer should maintain up-to-date and proper accounts of the transactions of
a business in his manufactory and deliver them to the proper officer by the 5th of each
month. The manufacturer is also required to furnish a list of all his employees who are
required to enter non-bonded manufactory, to the Excise Commissioner and only such
persons should be allowed to enter the laboratory.
5. Inspection:
The non-bonded laboratory can be inspected by the Excise Commissioner and other
having jurisdiction over the area in which the manufactory is situated. It shall be inspected at
once every month by the proper Excise officer. The State Government may authorize
inspection of the non-bonded establishment by any officer of Prohibition, Land Revenue or
Medical and Public Health Departments.
4.6 EXPORT OF ALCOHOLIC PREPARATIONS
No duty is required to be paid on alcoholic preparations which are exported from India.
Such preparations can be exported in either of the following two ways:
(i) Under bond (directly from a bonded laboratory without payment of duty), or
(ii) Under claim for rebate of duty.
Export under Bond:
Only those persons who have a bonded laboratory or a bonded warehouse can export
alcoholic preparations under bond. The exporter should present an application in triplicate to
the officer-in-charge of the laboratory or warehouse, stating whether the goods are to be
exported by land, sea, air or by post parcel. A separate application is required in respect of
each consignment. The officer-in-charge sends the original copy of the application to the
customs officer or the border examiner or the post master, as the case may be, at the place
Pharmaceutical Jurisprudence 4.9 Medicinal and Toilet Preparations …

of export. The duplicate is delivered to the consigner and the triplicate is retained as the
office copy. Goods for export should be packed in cases or packages and should be legibly
marked in ink or oil color with the following particulars:
1. Serial number commencing with 1 for each year.
2. Owner's name and special mark, if any.
3. The total quantity of dutiable goods with their alcohol content in L.P. litres.
After verifying the particulars entered in the application, the officer note particulars on
the body of each package:
(i) Name and address of the consignee.
(ii) Description of the goods.
(iii) The total quantity of goods packed.
(iv) The gross weight of the package.
The said officer shall then seal each package with his official seal in such a manner that
the package cannot be tempered with, without breaking the seal. The officer shall also
endorse all the copies of the application and specify the period within which the goods
should be actually exported and return the duplicate copy to the consigner. After dispatching
the goods, the consigner should enter the number and date of Railway Receipt or bill of
lading on the duplicate copy and communicate these particulars to the proper officer for
entry in the other copies.
If the goods are being sent by post, the exporter should present the duplicate copy of his
application, duly endorsed by the Excise officer, to the Post master at the office of booking
together with relevant packets or packages. Post master of the destination Post office should
certify on the duplicate application that the goods have been duly exported out of India and
return the same through the Post master at the Post office of booking, to the exporter who
shall present it to the officer-in-charge of his laboratory or warehouse.
Export of Duty Paid Goods:
Goods on which duty has already been paid can be exported under claim for rebate of
duty. The owner of a non-bonded manufactory or a warehouse dealer, who wants to export
duty paid goods should give at least 48 hours notice to the proper Excise officer for
supervising the packing of goods to be exported. The consigner should present the entire
consignment before the proper officer who shall take samples of the goods and send to the
Chemical examiner for analysis. On receipt of a report from the Chemical Examiner, he shall
enter the alcoholic content of the goods, in the duplicate copy of the application. This copy
of the application should be presented by the exporter to the Excise Commissioner for
claiming a rebate of excise duty.
After verifying the particulars entered in the application, the officer-in-charge may get
the following particulars entered on the body of each package:
(i) Name and address of the consignee.
(ii) Description of the goods.
(iii) The total quantity of goods packed and their alcoholic content in L.P. litres.
(iv) The gross weight of the package.
Pharmaceutical Jurisprudence 4.10 Medicinal and Toilet Preparations …

The officer-in-charge should then seal each package with his official seal so as to make
them temper proof. The packages can then be exported in the same manner as in the case of
the bonded goods. Claim for a rebate of duty has to be made within one month of the issue
of export certificate presenting the duplicate certified application to the Excise
Commissioner. The rebate is sanctioned by the Excise Commissioner if he is satisfied that the
claim is in order. The Excise Commissioner may extend the period within which such claim for
rebate shall be made.
4.7 MANUFACTURE OF AYURVEDIC, HOMEOPATHIC AND PATENT AND
PROPRIETARY PREPARATIONS
4.7.1 Ayurvedic Preparations
‘Asavas' and ‘Aristas' are the principal types of Ayurvedic preparations which contain self-
generated alcohol. The pharmacopoeias that are used in various States are presently
recognised as Ayurvedic pharmacopeias. Ayurvedic preparations containing self-generated
alcohol in which the alcohol content does not exceed 2% proof spirit are deemed to be
non-alcoholic and hence are exempted from the payment of the excise duty.
Preparations containing more than 2% alcohol but not capable of consumption as an
ordinary alcoholic beverage are also exempted from excise duty. The preparations which can
be consumed as alcoholic beverages are liable to a duty of ` 1 per L.P. litre. Registered
Ayurvedic Practitioners of good standing may be allowed to manufacture and dispense such
preparations free of duty, provided, they take license and use preparations only for their
patients. The practitioner should allow excise officer to take samples to ensure that the
preparations contain only self-generated alcohol and also maintain a daily account of all the
preparations manufactured and dispensed giving particulars of names and addresses of the
patients. Ayurvedic preparations made by distillation or to which alcohol is added at any
stage of manufacture are treated as preparations capable of being used as ordinary alcoholic
beverages and hence are liable to a duty of ` 30 per L.P. litre.
4.7.2 Homeopathic Preparations
All homoeopathic preparations containing alcohol are classified as being consumed as
ordinary alcoholic beverages and attract duties prescribed for such class of preparations
falling under the category of restricted preparations.
Patent and Proprietary Preparations:
All Allopathic preparations containing alcohol can be categorized into the following two
types:
1. Official preparations made strictly according to the formulae given in the current
editions of B.Р., В.Р.С., I.P., U.S.Р., N.F.(U.S.), any other pharmacopoeia recognised under the
Drugs and Cosmetics Act, 1940 by the Government of India, and Veterinary Codex
recognised by the Government of India.
2. Non-official allopathic preparations referred to as proprietary preparations which are
prepared according to the allopathic system of medicine and conform strictly to the formula
displayed on the label.
Medicinal and toilet preparations capable of being consumed as ordinary alcoholic
beverages are referred to as 'restricted preparations' and are enlisted in the Schedule.
Pharmaceutical Jurisprudence 4.11 Medicinal and Toilet Preparations …

All other standard preparations and proprietary preparations not being capable of being
consumed as alcoholic beverages are referred to as 'unrestricted preparations.
Any of the unrestricted preparations, if misused widely, may be declared to be restricted
preparations by the Central Government either on the request of the State Government or on
its own; and on the advice of the Standing Committee. Any new proprietary preparation is
presumed to be a restricted preparation unless declared to the contrary by the Central
Government on the advice of the Standing Committee. Any manufacturer wanting to
manufacture a proprietary preparation should submit two samples of the preparation
together with its formula to the State Government. The State Government shall then forward
the samples to the Central Government which seeking the advice of the Standing Committee,
will declare whether the sample is to be categorized as a restricted or an unrestricted
preparation.
The Standing Committee consists of the following members;
1. Drugs Controller of India.
2. Chief Chemist, Central Revenues Laboratory.
3. One pharmacologist nominated by the Central Government.
4. The adviser on Indigenous System of Medicine, Ministry of Heath, Family Planning
and Urban Development.
The Committee advises the Central Government on all matters connected with the
technical aspects of administration of the Act and the Rules and particularly whether (i) a
particular preparation is to be treated as a genuine medicinal or toilet preparation for the
purposes of the Act; and if so (ii) whether it should be treated or continue to be treated as a
restricted or unrestricted preparation.
4.8 OFFENCES AND PENALTIES
Sr. Offences Penalties
No.
1. Non-compliance with conditions of the Imprisonment up to 6 months or fine
license and failure to pay duty; or upto ` 200 or both.
2. Failure to supply information asked or Imprisonment up to 6 months or fine
giving false information; or upto ` 200 or both.
3. Attempting or committing or abetting Imprisonment up to 6 months or fine
commission of any offence. upto ` 200 or both.
4. The connivance of offences by owners or Imprisonment up to 6 months or fine
occupiers of land. up to ` 500 or both.
5. Vexatious search, seizure etc. by Excise Fine upto ` 2000 for every offence.
Officer.
6. Failure of Excise Officer on duty. Imprisonment up to 3 months or fine
up to 3 months pay or both.
7. Improper maintenance of stocks or Fine upto ` 100.
accounts.
8. Making false entries or tearing pages from Fine upto ` 2000 and goods liable to
stock book. confiscation.
9. Sale of dutiable goods otherwise than in Fine upto ` 1000 and goods liable to
prescribed containers bearing the labels. confiscation.
10. Failure to furnish proof of export within Fine upto ` 2000.
specified period.
Pharmaceutical Jurisprudence 4.12 Medicinal and Toilet Preparations …

Sr. Offences Penalties

No.
Offences with respect to Warehousing:
1. Opening any locks or door of the Fine upto ` 2000 and goods liable to
warehouse without prior consent; or confiscation.
2. Making any alteration in the warehouse Fine upto ` 2000 and goods liable to
without prior consent; or confiscation.
3. Warehousing or removing goods in Fine upto ` 2000 and goods liable to
contravention of the rules; or confiscation.
4. Privately removing or concealing any goods Fine upto ` 2000 and goods liable to
either before or after being warehoused; confiscation.
5. Obstructing officers and giving false Fine upto ` 500.
information.
6. Willfully and maliciously giving information. Imprisonment up to 2 years or fine up
to ` 2000 or both.

EXERCISE
1. Define the following terms in relation to Medicinal and Toilet preparations Act
(a) Absolute alcohol
(b) Denatured alcohol
(c) Rectified spirit
(d) Restricted preparation
2. Define Bonded laboratory. Enlist the requirements of a bonded laboratory.
3. Describe the manufacturing process of alcoholic preparations in Bonded laboratory.
4. Define non-bonded laboratory. Explain the steps involved in the manufacturing of
alcoholic preparations in Non-bonded laboratory.
5. Discuss the rules and provisions for getting license for manufacture of alcoholic
preparations as per MTP Act.
6. Describe the manufacturing of ayurvedic, homoeopathic, patent and proprietary
preparations containing alcohol as per MTP Act.
7. Discuss briefly the export of alcoholic preparations under medicinal and toilet
preparations Act.
8. Discuss the offences and penalties of Medicinal and Toilet preparations Act.

BIBLIOGRAPHY
1. Agarwal SP and Khanna R., Pharmaceutical Jurisprudence and Ethics, 5th ed, reprint.
New Delhi: Birla Publications Pvt. Ltd; 2005.
2. Jain NK, A text book of Forensic Pharmacy, 8th ed, reprint. Delhi: Vallabh Prakashan;
2014.
3. Mithal BM. A Text Book of Forensic Pharmacy, 10th ed, reprint. Delhi: Vallabh
Prakashan; 1998.
✱✱✱
Chapter ... 5
NARCOTIC DRUGS AND
PSYCHOTROPIC SUBSTANCES
ACT, 1985 AND RULES

♦ LEARNING OBJECTIVES ♦
After completing this chapter, the reader should be able to understand:
The objectives of NDPS Act.
The composition and roles of Narcotic drugs and Psychotropic sbstances consultative
cmmittee.
The prohibition, control and regulations by central and state governments.
The rules for the cultivation, production, manufacture, sale and export of opium as
per NDPS Act.
The purpose and function of National fund for drug abuse.
Offences and penalties of the Act.

5.1 INTRODUCTION
Coca, hemp, and opium are considered to be medicinal drugs but because of their habit
forming and degenerating effect, their use has been restricted from the social point of view.
Opium was brought under legislative control in 1857 after framing Opium Act with the main
objective to protect public welfare by preserving the health and eliminating undesirable
social and moral effects commonly associated with indiscriminate use of the drugs.
In the present day, drugs like heroin, brown sugar, charas and many more have been
added to the list of habit forming drugs. The unfortunate fact was that, these narcotic drugs
and psychotropic substances are creating an increasing number of addicts in all the corners
of the world. Smuggling and sale of narcotic drugs and psychotropic substances is still a
lucrative business amongst anti-social elements.
With the passage of time and the developments in the field of illicit drug traffic and drug
abuse at the national and international level, the statutory control [particularly the Opium
Act, 1857, the Opium Act, 1858 and the dangerous Drugs Act, 1930] was found to be
inadequate and required fresh legislation. This resulted in the enactment of the Narcotic
Drugs and Psychotropic Substances Act and Rules, 1985.

(5.1)
Pharmaceutical Jurisprudence 5.2 Narcotic Drugs and Psychotropic …

The Act came in force on 14 November 1985 and extends to the whole of India and it
also applies (a) to all citizens of India outside India; (b) to all persons on ships and aircrafts
registered in India, wherever they may be.
5.2 OBJECTIVES OF THE NDPS ACT
1. To consolidate and amend the existing laws relating to Narcotic Drug.
2. To make stringent provisions for the control and regulation of operations relating to
Narcotic Drugs and Psychotropic Substances.
3. To considerably enhance the penalties particularly for trafficking offences.
4. To make provisions for the implementations of International Conventions relating to
Drugs and Psychotropic Substances to which India is a party.
5.3 DEFINITIONS OF THE ACT
Cannabis (hemp) means
(i) Charas, i.e., the separated resin, in whatever form, whether crude or purified,
obtained from the cannabis plant and also includes concentrated preparation and
resin known as hashish oil or liquid hashish.
(ii) Ganja, i.e, the flowering or fruiting tops of the cannabis plant (excluding the seeds
and leaves when not accompanied by the tops), by whatever name they may be
known as designated.
(iii) Any mixture, with or without any neutral material, or any of the above forms or
cannabis or any drink prepared there from.
Cannabis Plant means any plant of the genus cannabis.
Coca Derivative means
(i) Crude cocaine, i.e., any extract of coca leaf which can be used, directly or indirectly,
for the manufacture of cocaine.
(ii) Ecgonine and all the derivatives of ecgonine from which it can be recovered.
(iii) Cocaine, i.e., methyl ester of benzoyl-ecgonine and its salts.
(iv) All preparations containing more than 0.1% of cocaine.
Coca Leaf means
(i) The leaf of the coca plant except a leaf from which all ecgonine and any other
ecgonine alkaloids have been removed.
(ii) Any mixture thereof with or without any neutral material.
(iii) But does not include any preparation containing not more than 0.1 percent of
cocaine.
Coca Plant means the plant of any species of the genus Erythroxylon.
Controlled substance means any substance which the Central Government may, having
regard to the available information as to its possible use in the production or manufacture of
narcotic drugs or Psychotropic substances or to the provisions of any International
Convention, by notification in the official gazette, declare to be a controlled substance.
Illicit traffic in relation to Narcotic Drugs and Psychotropic Substances means
(i) Cultivating any coca plant or gathering any portion of coca plant.
(ii) Cultivating the opium poppy of any cannabis plant.
Pharmaceutical Jurisprudence 5.3 Narcotic Drugs and Psychotropic …

(iii) Engaging in the production, manufacture, possession, sale, purchase, transportation

warehousing, concealment, use or consumption, import inter-state, export inter-
State, import into India, export from India or transhipment of narcotic drugs or
Psychotropic substances.
(iv) Dealing in any activities in narcotic drugs or Psychotropic substances other than
those referred to above.
(v) Handling or letting out any premises for carrying on of any of the activities referred
to above.
Manufacture in relation to narcotic or psychotropic substances includes
(i) All processes other than production by which such drugs or substances may be
obtained.
(ii) Refining of such drugs or substances.
(iii) Making of preparation (otherwise than in a pharmacy on prescription) with or
without containing drugs or substances.
Manufactured Drug means
(i) All coca derivatives, medicinal cannabis, opium derivatives and poppy straw
concentrate.
(ii) Any other substance or preparation which the Central Government may, by
notification in the official Gazette, declare to be a manufactured drug.
Medicinal Cannabis or Medicinal Hemp means any extract or tincture of cannabis
(hemp).
Narcotic Drug means coca leaf, cannabis (hemp), opium straw and includes all
manufactured goods.
Opium means:
(i) The coagulated juice of the opium poppy.
(ii) Any mixture, with or without any neutral material, of the coagulated juice of the
opium poppy, but does not include any preparation containing not more than
0.2 per cent of morphine.
Opium Derivative means
(i) Medicinal opium, i.e., opium which has undergone the processes necessary to adopt
it for medicinal use in accordance with the requirements of the Indian
Pharmacopoeia or any other pharmacopoeia notified in this behalf by the Central
Government, whether in powder form or granulated or otherwise or mixed with
neutral materials.
(ii) Prepared opium, that is any product of opium by any series of operations designed
to transform opium into an extract suitable for smoking and the dross or other
residue remaining after opium is smoked
(iii) Phenanthrene alkaloids, namely morphine, codeine, thebaine and their salts.
(iv) Diacetylmorphine, that is, the alkaloid also known as dia-morphine or heroine and its
salts.
(v) All preparations containing more than 0.2 per cent of morphine or containing any
diacetyl morphine.
Pharmaceutical Jurisprudence 5.4 Narcotic Drugs and Psychotropic …

Opium Poppy means

(i) The plant of the species Papaver somniferum L.
(ii) The plant of any other species of Papaver from which opium or any phenanthrene
alkaloid be extracted and which the Central Government may, by notification in the
official Gazette declare, to be opium poppy for the purposes of this act.
Poppy Straw means all parts (except the seeds) of the opium poppy after harvesting
whether in their original or cut, crushed or powdered and whether or not juice has been
extracted there from.
Poppy Straw Concentrate means the material arising when poppy straw has entered
into a process for the concentration of its alkaloids.
Psychotropic Substance means any substance, natural or synthetic, or any natural
material or any salt or preparation of such substance or material included in the list of
Psychotropic substances specified in the Schedule.
5.4 AUTHORITIES AND OFFICERS
1. Measures by Central Government:
To prevent and combat abuse of narcotic and psychotropic substances and the illicit
traffic therein, the Central Government may take measure with respect to the following
matters;
(a) Co-ordination of actions by various officers, State Government, and other authorities
under this Act or under any other law for the time being in force in connection with
the enforcement of the provisions of this Act;
(b) Obligations under the International Conventions;
(c) Assistance to the concerned authorities in foreign countries and international
organizations to facilitate co-ordination and universal action for prevention and
suppression of illicit traffic in narcotic drugs and psychotropic substances.
(d) Identification, treatment, education, after care, rehabilitation and social re-
integration of addicts; and
(e) Such other matters as the Central Government deems necessary expedient for the
purpose of this Act and preventing and combating the abuse of narcotic drugs and
psychotropic substances and illicit traffic therein.
The Central Government is also empowered to constitute an authority for the purpose of
exercising such powers and for taking measures with respect to the matters mentioned
above or specified in an order.
Such authority or authorities may exercise the powers and functions and take measures,
subject to the supervision and control of the Central Government and the provisions of such
order as if empowered by this Act to exercise those powers and take such measures.
2. Officers of Government:
In addition to the above authorities, the Central Government shall appoint a Narcotics
Commissioner and such other officers as it thinks fit for the purpose of this Act. The Narcotics
Commissioner shall exercise all powers and perform all functions relating to the
superintendence of the cultivation of the opium poppy and production of opium and shall
Pharmaceutical Jurisprudence 5.5 Narcotic Drugs and Psychotropic …

exercise and perform such other powers and functions as may be entrusted to him by the
Central Government. The officers shall be subject to the general control and direction of the
Central Government, or if so directed by the Government, also of the Board or any other
authority or officer. The Narcotics Commissioner may authorise any officer subordinate to
him, to exercise all or any of his powers under the Rules. The Narcotics Commissioners and
such other officers as may be appointed by the Central Government, may perform all or any
of the functions, or exercise any of the powers assigned under the rules to the officers
subordinate to them.
3. Officers of State Government:
The State Government may appoint officers with such designations as it thinks fit for the
purpose of this Act. These officers shall be subjected to general control and direction of the
State Government, or if so directed by that Government, also of any other authority or
officer.
5.5 NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES
CONSULTATIVE COMMITTEE
The Central Government may constitute an advisory committee to be called The Narcotic
Drugs and Psychotropic Substances Consultative Committee in order to advise it on such
matters relating to the administration of this Act as may be referred to it by that Government
from time to time.
The Committee shall consist of a Chairman and such other members, not exceeding
twenty, as may be appointed by the Central Government. It shall meet when required to do
so by the Central Government and shall have the power to regulate its own procedure.
The Committee may, for the efficient discharge of its functions, constitute one or more
sub-committees and may appoint to such sub-committee any person who is a not member
of the Committee. The term of office, the manner of filling casual vacancies in the offices, the
allowances payable to the Chairman and other members of the Committee and other
procedures shall be such as may be prescribed by rules made by the Central Government.
5.6 NATIONAL FUND FOR CONTROL OF DRUG ABUSE
The Central Government may, by notification in the Official Gazette, constitute a Fund to
be called the National Fund for Control of Drug Abuse (hereafter in this Chapter referred to
as the Fund) and there shall be credited thereto—
(a) An amount which the Central Government may, after due appropriation made by
Parliament by law in this behalf, provide;
(b) The sale proceeds of any property forfeited under Chapter VA;
(c) Any grants that may be made by any person or institution;
(d) Any income from investment of the amounts credited to the Fund under the
aforesaid provisions.
The Fund shall be applied by the Central Government to meet the expenditure incurred in
connection with the measures taken for—
(a) Combating illicit traffic in narcotic drugs, psychotropic substances or controlled
substances;
Pharmaceutical Jurisprudence 5.6 Narcotic Drugs and Psychotropic …

(b) Controlling the abuse of narcotic drugs and psychotropic substances;

(c) Identifying, treating, rehabilitating addicts;
(d) Preventing drug abuse;
(e) Educating the public against drug abuse;
(f) Supplying drugs to addicts where such supply is a medical necessity.
The Central Government may constitute a Governing Body as it thinks fit to advise that
Government and to sanction money out of the said Fund subject to the limit notified by the
Central Government in the Official Gazette.
The Governing Body shall consist of a Chairman (not below the rank of an Additional
Secretary to the Central Government) and such other members not exceeding six as the
Central Government may appoint. The Governing Body shall have the power to regulate its
own procedure. The Central Government shall, as soon as may be, after the end of each
financial year, cause to be published in the Official Gazette, a report giving an account of the
activities financed under section 7A during the financial year, together with a statement of
accounts.
5.7 PROHIBITION, CONTROL AND REGULATION
The following operations are totally prohibited under the Narcotic Drugs and
Psychotropic Substances Act:
(i) Cultivation of any coca plant or gathering of any portion of the coca plant.
(ii) Cultivation of opium poppy or any cannabis plant.
(iii) Production, manufacture, possession, sale, purchase, transportation, warehousing
consumption, import, export etc. of any Narcotic drug or Psychotropic substance,
except for medical or scientific purposes and in the manner and to the extent
provided or in accordance with the terms and conditions of a license, permit or
authorization, if provided.
The prohibition shall take effect only from the date which the Central Government, may,
by notification in the Official Gazette specify in this behalf.
Power of Central Government to Permit, Control and Regulate:
The Central Government may, by rules:
1. Permit and regulate:
(a) The cultivation, or gathering of any portion (only on account of the Central
Government) of coca plant, or the production, possession, sale, purchase, transport,
import inter-state, export inter-state, use or consumption of coca leaves.
(b) The cultivation (only on account of the Central Government) of the opium poppy.
(c) The production and manufacture of the opium and production of poppy straw.
(d) The sale of opium and opium derivatives from the Central Government factories for
the export from India or sale to State Government or to the manufacturing chemists.
(e) The manufacture of manufactured drugs (other than prepared opium) but not
including manufacture of medicinal opium or any preparation containing any
manufactured drug from materials which the maker is lawfully entitled to possess.
(f) The manufacture, possession, transport, import inter-state, export inter-state, sale,
purchase, consumption or use of Psychotropic substances.
Pharmaceutical Jurisprudence 5.7 Narcotic Drugs and Psychotropic …

(g) The import into India and export from India and transhipment of Narcotic drugs and
Psychotropic substances.
2. Prescribe any other matter required to render effective the control of the Central
Government over any of the matters specified above.
The Central Government may permit, with or without conditions, and on its behalf, the
cultivation of any coca plant or gathering of any portion thereof or the production,
possession, sale, purchase import inter-State, export inter-state, or import into India of coca
leaves for use in preparation of any flavouring agent which shall not contain any alkaloid for
such use. The Central Government may also allow cultivation of any cannabis plant for
industrial purposes only or obtaining fibre or seed or for horticultural purposes.
The Central Government may also, if it deems necessary, provide for the regulation of the
production, manufacture, possession, transport, import inter-state, export inter-state, sale,
purchase, consumption, use, storage, distribution, disposal or acquisition of any controlled
substance.
Power of State Government to Permit, Control and Regulate:
The State Government may, by rules
1. Permit or regulate:
(i) The possession, transport, import inter-state, export inter-state, warehousing, sale,
purchase, consumption, and use of a poppy straw.
(ii) The possession, transport, import inter-state, export inter-state, sale, purchase,
consumption and use of opium.
(iii) The cultivation of any cannabis plant, production, manufacture, possession,
transport, import inter-state, export inter-state, sale, purchase, consumption or use
of cannabis (excluding charas).
(iv) The manufacture of medicinal opium or any preparation containing drug from
materials which the maker is lawfully entitled to possess.
(v) The possession, transport, purchase, sale, import inter-state, export inter-state, use.
Consumption of manufactured drugs other than prepared opium and of coca leaf,
any preparations containing any manufactured drug.
(vi) The manufacture and possession of prepared opium from opium lawfully possessed
by an addict registered with the State Government on medical advice for his
personal consumption.
2. Prescribe any other matter requisite to render effective the control of the State
Government over any of the matters specified above.
5.8 CULTIVATION OF OPIUM POPPY AND PRODUCTION OF OPIUM OR
POPPY STRAW CULTIVATION
According to NDPS Act, no person can cultivate or engage production of opium or poppy
straw except on behalf of the Central Government and under a license granted for the
purpose in such parts of the country as may be specified. For the cultivation of opium in
specified area and plots licenses are issued by the District Opium Officers.
Pharmaceutical Jurisprudence 5.8 Narcotic Drugs and Psychotropic …

The District Opium Officer may also designate one of the licensed cultivators as
Lambardar in each village who shall perform such functions and on such terms as may be
specified by the Narcotic Commissioner. The licenses granted by District Opium Officers may
be withheld or cancelled by higher officers after giving a chance to the cultivator for being
heard. If any opium is cultivated under a license which is subsequently cancelled, the
standing crop may be destroyed under the supervision of an authorised officer in such
manner as may be specified by the Narcotic Commissioner.
Production of Opium:
During harvesting, cultivators shall daily take their day's collection of Opium to
Lambardar for weighment of quantity produced on the day and entry in records which
should be jointly attested, every day by the Lambardar and the cultivator. These records shall
be checked by authorised officers. In case of any discrepancies between quantity produced
and quantity entered in the records, an enquiry shall be made by an authorised officer to
determine the liability of the cultivator for punishment.
All opium produced has to be delivered to District Opium Officers who shall weigh,
examine and classify the same according to its quality and consistence and forward it to the
Government Opium Factory in such manner as may be specified by the Narcotic
Commissioner. A cultivator who is dissatisfied with the classification done by the officer may
have the opium forwarded to Government Opium Factory. All opium forwarded to
Government factory has to be classified under the supervision of the General Manager in
such manner as may be specified by the Narcotic Commissioner. If the District Opium Officer
suspects any opium delivered to him to be adulterated, he may send it separately to
Government Opium Factory after sealing in the presence of the lambardar and cultivator.
Adulterated opium is liable to confiscation after giving a hearing to the cultivator.
Fixation of Price of Opium:
The Central Government shall, from time to time, fix the price of opium, to be paid to the
cultivators. Such price shall be fixed per kilogram of the opium of a standard consistence.
5.9 MANUFACTURE, SALE, AND EXPORT OF OPIUM
5.9.1 Manufacture of Opium
Manufacture of Opium can be made only by the Central Government at its two factories
situated at Ghazipur and Neemuch. However, opium mixtures may be manufactured from
lawfully possessed opium by a person authorised under the rules made by the State
Government for the said purpose.
5.9.2 Sale of Opium
Sale of opium to State Governments or manufacturing chemists can be made only from
the Government Opium Factory, Ghazipur. The sale to manufacturing chemists is possible
only under permit it from the concerned State Government within whose jurisdiction; the
chemist resides or has his place of business. The permit by the State Government shall be
issued in quadruplicate. One copy shall be retained by the issuing authority and the
remaining copies forwarded to the Government Opium Factory, Ghazipur. The factory shall
retain the duplicate copy for the record, send the original copy with the consignment of
Pharmaceutical Jurisprudence 5.9 Narcotic Drugs and Psychotropic …

opium and return the triplicate copy to the issuing authority after endorsing thereon the
quantity actually supplied and the date of dispatch.
The price to be charged for opium sold by the Government Factory shall be fixed, from time
to time by the Central Government.
5.9.3 Export of Opium
The export of opium is prohibited except when it is on the behalf of the Central
Government.
5.10 OFFENCES AND PENALTIES
Sr. Offence Penalty
No.
1. Contraventions of provisons in the Act or Rigorous imprisonment upto 10 to 20
Rules in relation to poppy straw, opium years and fine of not less than ` 1 lakh
poppy, coca leaves, prepared opium, on first conviction and with Rigorous
manufactured drugs and psychotropic imprisonment upto 15 to 30 years and
substances. a fine of ` 2 lakh on second and
subsequent conviction.
2. Illegal import or export or external dealings Rigorous imprisonment upto 10 to 20
in narcotic drugs or psychotropic years and fine of not less than ` 1 lakh
substances. rupees on first conviction and with
Rigorous imprisonment upto 15 to 30
years and a fine of ` 2 lakh on second
and subsequent conviction.
3. Embezzlement of opium by the cultivator. Rigorous imprisonment upto 10 to 20
years and fine of not less than ` 1 lakh
rupees on first conviction and with
Rigorous imprisonment upto 15 to 30
years and a fine of ` 2 lakh on second
and subsequent conviction.
4. Allowing use of premises, conveyance, for Rigorous imprisonment upto 10 to 20
commison of an offence under the Act. years and fine of not less than ` 1 lakh
rupees on first conviction and with
Rigorous imprisonment upto 15 to 30
years and a fine of ` 2 lakh on second
and subsequent conviction.
5. Contravention in relation to the cannabis Rigorous imprisonment upto 10 to 20
plant and cannabis other than ganja. years and fine of not less than ` 1 lakh
rupees on first conviction and with
Rigorous imprisonment upto 15 to 30
years and a fine of ` 2 lakh on second
and subsequent conviction.
6. Contravention of the provisions in the Act Rigorous imprisonment for 5 years
or Rules in respect of cannabis plant and and fine upto ` 50,000 on first
Pharmaceutical Jurisprudence 5.10 Narcotic Drugs and Psychotropic …

Sr. Offence Penalty

No.
cannabis related to ganja. conviction and rigorous imprisonment
for 10 years and fine upto ` 1 lakh on
second and subsquent conviction.
7. Illegal possession in small quantities for Imprisonment upto 1 year or fine or
personal consumption or consumption of both.
cocaine, morphine, diacetylmorphine or
any other narcotic drug or psychotropic
substances specified in this behalf.
8. Keeping false accounts or making false Imprisonment upto 5 years or fine or
statements. both.
9. Failure to produce a license, permit or Imprisonment upto 5 years or fine or
authorization on demand by an authorized both.
person.
10. Failure to maintain accounts or submit any Imprisonment upto 5 years or fine or
return without any reasonable cause in both.
accordance with the provisions of this Act.

EXERCISE
1. Enlist the objectives of NDPS Act.
2. Define the following terms in relation to NDPS Act.
(i) Cannabis
(ii) Coca derivative
(iii) Illicit traffic
(iv) Opium derivative
(v) Opium poppy
3. Discuss the role of Narcotic Drugs and Psychotropic Substances Consultative
Committee.
4. Explain the prohibition, control and regulation for opium by central and state
government of India under NDPS Act.
5. Describe the rules for the cultivation, production, manufacture, sale and export of
opium as per NDPS Act.
6. Discuss about the National Fund for controlling the Drug Abuse under NDPS Act.
7. Discuss the offences and penalties of Narcotic Drugs and Psychotropic Substances
Act (NDPS).
BIBLIOGRAPHY
1. Agarwal SP and Khanna R., Pharmaceutical Jurisprudence and Ethics, 5th ed, reprint.
New Delhi: Birla Publications Pvt. Ltd., 2005.
2. Jain NK, A text book of Forensic Pharmacy, 8th ed, reprint. Delhi: Vallabh Prakashan;
2014.
3. Mithal BM, A text book of Forensic Pharmacy, 10th ed, reprint. Delhi: Vallabh
Prakashan; 1998.
✱✱✱
 UNIT IV

Chapter ... 6
THE DRUGS AND MAGIC REMEDIES
(OBJECTIONABLE ADVERTISEMENTS)
ACT AND ITS RULES

♦ LEARNING OBJECTIVES ♦
After completing this chapter, the reader should be able to understand:
The objectives of Drugs and Magic remedies Act.
The types of Prohibited and Exempted advertisements.
The offences and penalties of the Act.

6.1 INTRODUCTION
In today’s modern life, advertisements have significant role to provide information
regarding the usage of products like cosmetics, electronic gadgets and many more. Modern
methods of advertising like TV, internet, cell phones etc. have proved to be very effective.
Advertising drugs including medicinal products to the normal people may lead to self
medication which may be resulted in serious complications. To overcome such demerits an
implementation was made that drugs should be advertised only to qualified persons like
doctors, nurses, pharmacists and other health professionals.
One of the commonly faced problems in India is advertisement of magic remedies like
kavachas, mantras, talismans which are believed to be curative remedies for diseases for
which no cure or treatment is available. Because of this, innocent persons fall in the trap of
such unsocial elements and waste their money and time. To control and inhibit all these
issues, the Drugs and Magic Remedies Act was passed in the year 1954 with a view to control
and prohibit certain advertisements of drugs and magic remedies which were likely to
mislead the general public.

(6.1)
Pharmaceutical Jurisprudence 6.2 The Drugs and Magic Remedies

The Act came into effect from April 1st 1955 and was implemented in 1963. The Act
extends to whole of India except the state of Jammu and Kashmir. The Act was also referred
as Objectionable Advertisements Act.
6.2 OBJECTIVES
1. To control some of the drug related advertisements which can mislead the public.
2. To prohibit certain kind of advertisements related to magic remedies which make
false claims and are likely to mislead the public.
6.3 DEFINITIONS
Advertisement: It includes all the notices, labels, circulars, wrappers or other documents
and all the announcements made orally or by means of producing or transmitting light,
sound or smoke.
Drug: It includes the following definitions:
(i) A medicine for the internal or external use of human beings or animals.
(ii) Any substance intended to be used for or in the diagnosis, cure, mitigation,
treatment or prevention of diseases in human beings or animals.
(iii) Any article, other than food, intended to affect the body of human beings.
(iv) Any article intended for use as a component of any medicine, substance or article
referred to above.
Magic Remedy: It includes talismans, mantras, kavachas and any other charm of any
kind which is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation,
treatment or prevention of any diseases in human beings or animals or for affecting in any
way the structure or any organic function of the body of human beings or animals.
6.4 PROHIBITED ADVERTISEMENTS
The following are the classes of advertisements that are prohibited under the Act:
1. Advertisements, relating to drugs, which are likely to lead to their use in the following
ailments or conditions:
(a) For the procurement of miscarriage or prevention of conception in women.
(b) For the correction of menstrual disorders in women.
(c) For the maintenance or improvement of the capacity of human beings for sexual
pleasure.
(d) The diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or
condition specified in Schedule J of the Drugs and Cosmetics Rules, 1945.
2. Advertisements which:
(a) Directly or indirectly gives a false impression regarding the true character of the drug.
(b) Make a false claim for the drug.
(c) Are otherwise false or misleading in any material particular.
3. Advertisements relating to magic remedies claiming their efficacy for any of the
conditions outlined in (1) by persons, who purport to carry on the profession of
administering magic remedies.
Pharmaceutical Jurisprudence 6.3 The Drugs and Magic Remedies

Advertisements Whose Import and Export are Prohibited:

Import and export of all documents containing an advertisement of nature referred to
above is prohibited. Any documents containing any such advertisements are deemed to be
goods of which import or export has been prohibited under the Sea Customs Act, 1878.
6.5 EXEMPTED ADVERTISEMENTS
The following classes of advertisements and displays are exempted from the purview of
the Act and hence can be made without any prohibition:
1. Any sign boards or notices displayed by Registered Medical Practitioner (RMP)
indicating that treatment is undertaken for the disease or disorder, advertisements
relating to which are otherwise prohibited.
2. Any books or treaties relating to the diseases or ailments which are otherwise
advertised, provided published from bonafide scientific or social standing.
3. Any drug related advertisements sent confidentially, in the prescribed manner, to
RMP's. However, such advertisements should bear the following words on top, in a
conspicuous manner: For the use only of RMP or a Hospital or a Laboratory.
4. Any advertisement relating to a drug printed or published by the Government or by
any person with the prior permission of the Government.
5. Advertisements, labels or set of instructions which are permitted under the Drugs and
Cosmetics Act or Rules made there under.
The Central Government may also permit the advertisement of any drug which it feels
shall be in the interest of the public.
Advertisements Exempted Conditionally:
The following classes of advertisements have been exempted conditionally:
Class of Advertisement:
1. Leaflets or literature accompanying packing of drugs.
2. Advertisements of drugs in medical, pharmaceutical, scientific and technical journals.
Conditions:
(i) The advertisement contains only such information as it is required for the guidance of a
registered medical practitioner in respect of matters relating to:
(a) Therapeutic indications of the drug.
(b) Administration and dosage of the drug.
(c) Side effects of the drug.
(d) The precautions to be observed in the treatment with the drug.
(ii) The responsibility to prove that any claim made in the advertisement is not false,
exaggerated or misleading shall lie on the advertiser.
Pharmaceutical Jurisprudence 6.4 The Drugs and Magic Remedies

Class of Advertisement:
1. Price lists or therapeutic indexes published by manufacturers, importers or
distributors of drugs duly licensed under the Drugs and Cosmetics Act 1940 and the
Rules there under.
2. Medical literature distributed by medical or distributors of drugs, duly licensed under
the Drugs and Cosmetics Act, 1940 and the Rules there under.
Conditions:
(i) Conditions (i) and (ii) above.
(ii) The distribution of such literature is confined only to the registered medical
practitioners, hospitals, dispensaries, medical and research institutions, chemists and
druggists or pharmacies duly licensed under the provisions of the Drugs and
Cosmetic Rules.
Procedure for Sending Advertisements Confidentially:
All the documents containing advertisements relating to drugs to be sent confidentially
shall be sent by post to an RMP by name, or to a wholesaler or retail chemist, the address of
such RMP or wholesaler or retail chemist at the given address. Such documents shall bear at
the top, printed in indelible ink in a conspicuous manner, the words "For the use of
registered medical practitioner or a hospital or a laboratory".
Scrutiny of Misleading Advertisements Relating to Drugs:
Any person authorised by the State Government in this behalf, if satisfied that, a
particular advertisement has been made in contravention of the provisions of the Act, may
require the manufacturer, packer, distributor or seller in question to furnish, within the
specified time, information regarding the composition of the drug or its ingredients or any
other information he deems necessary for scrutinizing the advertisement. Such a
manufacturer, packer, distributor or seller shall be duty bound to comply with this order.
Provided that no publisher or advertising agency taking part in the publication of a
prohibited advertisement shall be deemed guilty, unless he has failed to comply with any
direction made by the authorised person in this behalf calling upon him to furnish the name
and address of the manufacturer, packer, distributor or seller of advertising agency,
who/which caused the publication of such advertisement.
6.6 OFFENCES AND PENALTIES
Whoever contravenes any of the provision of this Act or Rules made there under shall be
punishable with imprisonment upto six months or with fine or both on a first conviction, and
imprisonment upto one year or fine or both on any subsequent conviction.
If the person contravening any of the provisions of this Act is a company, every person
who, at the time the offence was committed, was in charge of, and was responsible for the
conduct of its business, as well as the company, shall be deemed to be guilty and punished
Pharmaceutical Jurisprudence 6.5 The Drugs and Magic Remedies

accordingly, unless it is proved that the offence was committed without his knowledge or
that he had exercised due diligence to prevent the commission of that offence. If it is proved
that, the offence by a company was committed with the consent or connivance of, or is
attributable to any neglect on the part of, any director, manager, secretary etc. of the
company, such person shall also be deemed to be guilty of that offence and shall be
punished accordingly.
Where a person has been convicted under this Act, the court may direct the forfeiture of
any document, article or thing, in respect of which the contravention is made including the
contents thereof.
An offence punishable under this Act shall be cognizable and cannot be tried by any
court inferior to that of a presidency magistrate or a magistrate of the first class.
No suit, prosecution or another legal proceeding shall lie against any person for anything
done in good faith or intended to be done under this Act.
Schedule J: Diseases which cannot be claimed to be cured (Drugs and Cosmetics Rules,
1945).
Prohibition of advertisement of certain drugs for treatment of certain diseases and disorders
like AIDS, Appendicitis, Arteriosclerosis, Asthma, Blindness, Blood poisoning, Bright's disease,
Cancer, Cataract, Deafness, Diabetes, Diseases and disorders of brain, optical system and
uterus; Disorders of menstrual flow, nervous system and prostatic gland; Dropsy, Epilepsy,
Female diseases (in general), Fits, Form and structure of female bust; Gall stones, kidney
stones and bladder stones; Gangrene, Glaucoma, Goitre Heart diseases, High or low blood
pressure, Hydrocele, Hysteria, Infantil paralysis, Insanity, Leprosy, Leucoderma, Lockjaw,
Locomotor ataxia, Lupus, Nervous debility, Obesity, Paralysis, Plague, Pleurisy, Pneumonia,
Rheumatism, Ruptures, Sexual impotence, Smallpox, Stature of persons, Sterility in women,
Trachoma, Tuberculosis, Typhoid fever, Ulcers of gastrointestinal tract, Venereal diseases
including syphilis, gonorrhea, soft chancre, venereal granuloma and lympho granuloma.

EXERCISE
1. Discuss about the provisions under which the Drugs and Magic Remedies Act.
2. Define the following terms in relation to Drugs and Magic Remedies Act:
(a) Advertisement
(b) Drug
(c) Magic remedy
3. Discuss the advertisements which are prohibited under Objectionable Advertisements
Act.
4. Enlist the classes of advertisements that are exempted conditionally under the Drugs
and Magic Remedies Act.
5. Discuss the offences and penalties of the Drugs and Magic Remedies Act.
Pharmaceutical Jurisprudence 6.6 The Drugs and Magic Remedies

BIBLIOGRAPHY
1. Agarwal SP and Khanna R., Pharmaceutical Jurisprudence and Ethics, 5th ed, reprint.
New Delhi: Birla Publications Pvt. Ltd; 2005.
2. Jain NK, A text book of Forensic Pharmacy, 8th ed, reprint. Delhi: Vallabh Prakashan;
2014.
3. Mithal BM, A text book of Forensic Pharmacy, 10th ed, reprint. Delhi: Vallabh
Prakashan; 1998.
✱✱✱
Chapter ... 7
THE PREVENTION OF CRUELTY TO
ANIMALS ACT, 1960
♦ LEARNING OBJECTIVES ♦
After completing this chapter, the reader should be able to understand:
The composition and functions of Institutional animal ethics committee.
The CPSCEA guidelines for animal handling and experimentation.
The conditions to suspend or revoke the CPSCEA registration for the approved animal
house.
The offences and penalties of the Act.

7.1 INTRODUCTION
For the scientific drug research studies, animals have been used as experimental subjects
because of their physiological similarity to human beings. In order to establish the
therapeutic efficiency and the safety of drugs, usage of laboratory animals for
experimentation is unavoidable. During the pre-clinical study, animals may be subjected to
injury, pain and even they may die. But causing unnecessary pain is considered to cruelty and
unethical. The Prevention of cruelty to animals Act was enacted with the main objective to
prevent the infliction of unnecessary pain or suffering on animals. This act provides
information on the provisions of pharmaceutical interest which are related to Animal
Experimentations.
This Act extends to the whole of India except the state of Jammu and Kashmir.
7.2 DEFINITIONS
"Animal" is defined as any living creature other than a human being.
"Board" means the Animal Welfare Board established under section 4 of the Act.
"Breeder" means a person including an institution, which breeds animals for the purpose
of transfer to the authorised institution for performing experiments.
"Committee" means the committee constituted under section 15 of the Act for control
and supervision on animals.
Establishment means any individual, company, firm, corporation other than schools up
to higher secondary level, which performs experiments on animals.

(7.1)
Pharmaceutical Jurisprudence 7.2 The Prevention of Cruelty to Animals Act, 1960

Experiment means any programme or project involving use of animal for the acquisition
of knowledge of a biological, psychological, ethological, physical or chemical nature; and
includes the use of animal(s) in the production of reagents and products such as antigens
and antibodies, diagnostics, testing activity and establishment of transgenic stocks for the
purpose of saving or prolonging life or alleviating suffering or significant gains in well being
for people of the country or for combating any disease whether on human beings or animals.
Institutional Animals Ethics Committee means a body comprising of a group of
persons recognised and registered by the Committee for the purpose of control and
supervision on animals performed in an establishment which is constituted and operated in
accordance with procedures specified for the purpose by the Committee.
Contract research means any research undertaken by an individual, company, firm,
corporation or institution on behalf of a foreign individual, company, corporation or
institution for any consideration.
Cruelty to Animals Under the Act, "treating animals cruelly" means-
(a) Subjecting any animal to unnecessary pain or suffering or treatment, or
(b) Usage of any unfit animal for work or labour, or
(c) Willfully and unreasonably administering any injurious drug or substance to any
domestic or captive animal, or
(d) Keeping or confining any animal in any cage of insufficient size not permitting it
reasonable movement, or
(e) Failure to provide any animal with sufficient food, drink or shelter by its owner, or
(f) Unnecessarily torturing any animal or killing any animal in a cruel manner etc.
7.3 INSTITUTIONAL ANIMAL ETHICS COMMITTEE (IAEC)
The primary duty of IAEC is to work for the achievement of the objectives as mentioned
below.
(a) Experiments shall be performed under the supervision of a person duly qualified in
that behalf, that is, Degree or Diploma holders in Veterinary Science or Medicine or
Laboratory Animal Science of a University or an Institution recognised by the
Government for the purpose and under the responsibility of the person performing
the experiment;
(b) Experiments are performed with care and humanity and that as far as possible
experiments involving operations are performed under the influence of some
anesthetic of sufficient power to prevent the animals feeling pain;
(c) Animals which, in the course of experiments under the influence of anesthetics, are so
injured that their recovery would involve serious suffering, are ordinarily destroyed
while still insensible;
(d) Experiments on animals are avoided wherever it is possible to do so; as for example;
in medical schools, hospitals, colleges and the like, if other teaching devices such as
books, models, films and the like, may equally suffice;
(e) Experiments on larger animals are avoided when it is possible to achieve the same
results by experiments upon small laboratory animals like guinea-pigs, rabbits, mice,
rats, etc;
Pharmaceutical Jurisprudence 7.3 The Prevention of Cruelty to Animals Act, 1960

(f) As far as possible, experiments are not performed merely for the purpose of
acquiring manual skill;
(g) Animals intended for the performance of experiments are properly looked after both
before and after experiments;
(h) suitable records are maintained with respect to experiments performed on
animals.
IAEC will review and approve all types of research proposals involving small animal
experimentation before the start of the study. For experimentation on large animals, the case
is required to be forwarded to CPCSEA in prescribed manner with the recommendation of
IAEC.
IAEC is required to monitor the research throughout the study and after completion of
study through periodic reports and visit to animal house and laboratory where the
experiments are conducted. The committee has to ensure compliance with all regulatory
requirements, applicable rules, guidelines and laws.
Composition of IAEC:
Institutional Animals Ethics Committee shall include eight members as follows.
1. A biological scientist,
2. Two scientists from different biological disciplines,
3. A veterinarian involved in the care of the animal,
4. Scientist in-charge of animals facility of the establishment concerned,
5. A scientist from, outside the institute,
6. A non-scientific socially aware member and
7. A nominee of CPCSEA.
The specialist may be co-opted while reviewing the special project using hazardous
agents such as radio-active substance and deadly micro-organisms.
The Chairperson of the Committee and Member Secretary would be nominated by the
Institution from amongst the eight members. Members against Serial number 5,6 and 7 will
be nominated by CPCSEA, with a provision of a Link nominee for CPCSEA nominee.
7.4 BREEDING AND STOCKING OF ANIMALS
Only registered establishments can carry on the business of breeding of animals or trade
of animals for the purpose of experiments. Every breeder carrying on the business of
breeding animals or trade animals for the purpose of experiments shall apply for registration
within sixty days from the date of commencement of the Breeding of and Experiments on
Animals (Control and Supervision) Rules, 1998 and stop the breeding of animals if the
Committee subsequently refuses registration. The application for registration by a breeder
shall be made in the specified format to the Member-Secretary or any other person
authorised by Committee in this regard.
For registration of breeders (including universities and colleges), the Government of India
has set up the "Committee for the Purpose of Control and Supervision of Experiments on
Animals" (CPCSEA) under the Ministry of Social Justice and Empowerment, Shastri Bhavan,
New Delhi.
Pharmaceutical Jurisprudence 7.4 The Prevention of Cruelty to Animals Act, 1960

The Secretary or the authorised officer of the Committee may ask for information relating
to premises where the experiments are to be conducted, animal housing facilities, details of
breeding of animals and its trade, infrastructure including availability of manpower trained in
handling animals and for verification of facts mentioned in the application for registration;
and if satisfied, shall register such breeder. Every registered breeder shall maintain a day-to-
day register of particulars about the animals used for conducting experiments, with the
number of animals, the species, the age, gender, and other particulars. The Committee or any
other authorized officer may examine the register so maintained and if the Committee is not
satisfied even after opportunities given for improvement, it may take appropriate action.
The animals shall be stocked by the breeder and the establishment in a prescribed
manner. Animal houses shall be located in a quiet atmosphere undisturbed by traffic, and the
premises kept tidy, hygienic and the animals protected from drought and extremes of
weather. Animal cages and stables for large animals shall be such that animals can live in
comfort and overcrowding is avoided. There shall be satisfactory arrangements for looking
after the animals during off-hours and on holidays. The registered breeder shall adhere to
the detailed specifications notified by the Committee for housing, feeding, and maintenance
of various species to be used in animal experimentation. Where standards have been laid
down by the Indian Standards Institution (ISI), the cages or the stable shall conform to those
standards. Animal’s attendants must be suitably trained and experienced in the duties
allotted to them.
7.5 PERFORMANCE OF EXPERIMENTS
Performing experiments on animals for the purpose of advancement by the new
discovery of knowledge, which will be useful for saving or prolonging life, or alleviating
suffering, or for combating any disease in human beings animals or plants; is lawful. The
experiment shall neither be performed for the purpose of attaining or retaining manual skill
except in schools, colleges and recognized training institutions; nor by way of an illustration
or as a public demonstration. Where experiments are performed in any institution, the
responsibility is placed on the head of the institution and in cases where experiments are
performed outside the institution by an individual qualified in that behalf; the experiments
are performed on his responsibility. All experiments shall be performed by or under the
supervision of a duly qualified person from a an institution recognized under the Rules.
Experiments shall be performed with due care and humanity. For any experimental
procedure, the experiment should be designed using a minimum number of animals to give
statistically valid results at a 95% degree of confidence and animals which may give
scientifically valid results should be first preferred.
It must be ensured that, animals are not subjected to unnecessary suffering before,
during or after the performance of experiments on them. Experimental animals should be
properly looked both before and after experiments. Experiments involving severe operative
procedure shall be performed under the influence of anaesthetic administered by a trained
person to make animals free of pain throughout the experiment. In the course of
experiments under the influence of the anaesthetic, if animals are injured that recovery would
involve pain or suffering, they shall be destroyed humanely while still under the influence of
Pharmaceutical Jurisprudence 7.5 The Prevention of Cruelty to Animals Act, 1960

anaesthesia. If there is a reason to believe that an animal is suffering abnormal or severe pain
at any stage of a continuing experiment, it shall be painlessly destroyed at that stage
discontinuing the experiment.
7.6 TRANSFER AND ACQUISITION OF ANIMALS FOR EXPERIMENT
Transfer of any animal by way of sale or otherwise by a breeder to an unregistered
establishment is not permitted. An establishment shall acquire animals for experiments from
registered breeders only and shall maintain a record in this regard and shall produce the
same before the Committee, whenever required. However, In case of non-availability of the
animal from registered breeders, the animal may be procured from alternate legal sources
with prior written permission from the competent authority.
A breeder/establishment shall not acquire any animal by sale or otherwise except from a
registered breeder/establishment. Similarly, every establishment after the acquisition of
animal/animals shall not transfer such animal/animals by sale or otherwise to any other
person or establishment except to a registered breeder/establishment. However, the animals
used for experimentation in a production/breed improvement programme may be given out
by the breeder institution for domestic use. For the acquisition of laboratory bred
experimental rats and mice species of genetically defined strains not available in India, the
registered breeder/establishments shall take the permission of the Institutional Animal Ethics
Committee. A breeder or an establishment shall comply with the directions given by the
Committee for the Purpose of Controlling and Supervising Experiments on Animals (CPCSEA).
7.7 RECORDS
Every establishment/Institutional Animals Ethics Committee maintain a record of the
animals under its control and custody and furnish such information, as the Committee may,
from time to time require in the specified format. All laboratories shall inform the exact
number/species of animals to the Secretary or any other officer authorised in this regard by
the Committee as per the specified format.
7.8 POWER TO SUSPEND OR REVOKE THE REGISTRATION
If the Committee is satisfied that the rules made by it are not being complied with by any
establishment/breeder/Institutional Animals Ethics Committee or its directions are being
violated the Committee may, after giving a reasonable opportunity of being heard in the
matter, suspend or revoke the registration either for a specified period or indefinitely, or may
allow the establishment/breeder/Institutional Animals Ethics Committee to carry on subject
to such special conditions as the Committee may impose.
7.9 OFFENCES AND PENALTIES
Offence Penalty
1. Treating animals cruelly. 1. Fine up to ` 50 in the first instance. In
case of repeat offence within three
years, fine may extend to ` 100 or with
imprisonment up to three months or
both.
Pharmaceutical Jurisprudence 7.6 The Prevention of Cruelty to Animals Act, 1960

Offence Penalty
2. Contravention of any order made by or 2. Fine extending to ` 200.
committing a breach of any condition
imposed by the Committee.
3. Contravention or breach of condition in 3. The person in charge of the institution
any institution. shall be guilty of the offence and shall
be punishable accordingly.

EXERCISE
1. Discuss about the Prevention of Cruelty to Animals Act, 1960.
2. Write the constitution of IAEC.
3. Describe the CPSCEA guidelines as per the Prevention of Cruelty to Animals Act,
1960.
4. Define the following terms under the Prevention of Cruelty to Animals Act, 1960.
(a) Experiment
(b) Institutional Animal Ethics Committee (IAEC)
(c) Cruelty
5. Write the offences and penalties of the Prevention of Cruelty to Animals Act, 1960.

BIBLIOGRAPHY
1. Agarwal SP and Khanna R, Pharmaceutical Jurisprudence and Ethics, 5th ed, reprint.
New Delhi: Birla Publications Pvt. Ltd; 2005.
2. Jain NK, A text book of Forensic Pharmacy, 8th ed, reprint. Delhi: Vallabh Prakashan;
2014.
3. Mithal BM. A text book of Forensic Pharmacy, 10th ed, reprint. Delhi: Vallabh
Prakashan; 1998.
4. CPCSEA Guidelines - AAALAC International Available from:
https://www.aaalac.org/resources/SOP_CPCSEA.pdf
5. CPCSEA Guidelines Available from:
http://cpcsea.nic.in/Content/55_1_GUIDELINES.aspx
✱✱✱
Chapter ... 8
NATIONAL PHARMACEUTICAL
PRICING AUTHORITY
♦ LEARNING OBJECTIVES ♦
After completing this chapter, the reader should be able to understand:
The objectives and definitions of DPCO Act.
The calculation of retail price of drug formulations of the Act.
Fixation of ceiling and retail prices for Scheduled and Non-scheduled drug
formulations.
The National List of Essential Medicines with examples.

8.1 INTRODUCTION
Drugs are considered as essential commodities and they should be made available always
at a reasonable cost of price. Drug Price Control Orders (DPCO) are issued by the
Government, in exercise of the powers conferred under Section 3 of the Essential
Commodities Act, 1955, for enabling the Government to declare a ceiling price for essential
and life saving medicines (as per a prescribed formula) so as to ensure that these medicines
are available at a reasonable price to the general public. The latest Drug Price Control Order
(DPCO-2013) was issued on 15th May 2013.
8.2 HISTORY OF PRICE CONTROL POLICY
The Drug Policy of 1994, as implemented through the Drugs Prices (Control) Order, 1995,
was introduced in the context of the liberalization of the economy and the abolishment of
industrial licensing, as well as allowing of foreign investment in the country, including in the
drug industry. The principle for price control broadly adopted in this policy represented a
radical departure from the earlier policies. This envisaged control over prices on the basis of
drugs on the basis of economic criteria as represented in the market share of different
companies in the context of total market sales turnover of various drugs. Thus, those drugs
were brought under the ambit of price control, where the company turnover was of a
particular level and where the market share of leading producers was beyond a particular
level. The control over prices was to be on the basis of the cost of production with allowance
being given for post production expenses. As per the criteria of 1994 Policy, a list of 74 bulk
drugs was identified and these drugs, as well as the formulations based on these drugs
(around 1577 in number), were brought under the price control regime. Certain exceptions
(8.1)
Pharmaceutical Jurisprudence 8.2 National Pharmaceutical Pricing Authority

such as for small scale units, drugs produced through indigenous research and development,
etc. were envisaged for exemption under the Policy.
In the year 2000, further liberalization in the economy was effected, in light of which,
Foreign Direct Investment (FDI) in the pharmaceutical sector was brought in the automatic
route and the limit raised upto 100%. Following this, a new pharmaceutical pricing policy was
introduced in the year 2002 which further liberalized the span of control over pricing. The
turnover limit for purposes of price control was raised from ` 4 crores to ` 25 crores and the
parameters of market share were also relaxed further. All drugs where unit price did not
exceed ` 2.00 were also excluded from the ambit of price control. There were also
exemptions given for drugs developed through indigenous R&D, New Delivery Systems etc.
The 2002 Drug Policy was, however, challenged in the Karnataka High Court, which by
order dated 12.11.2002 issued stay on the implementation of this Policy. This order was
challenged by the Government in the Supreme Court which vacated the stay vide its order
dated 10.03.2002 but observed that Government shall consider and formulate appropriate
criteria for ensuring essential and life saving drugs not to fall out of the price control and
further directed to review drugs, which are essential and life saving in nature till
2nd May 2003”.
In the light of the order of the Supreme Court, it was decided that a fresh Pharmaceutical
Pricing Policy be formulated and accordingly, the 2002 Drug Policy was never implemented
and the 1994 Drug Policy continued to be applicable.
Meanwhile, in accordance with the guidelines of the Supreme Court, the Ministry of
Health revised the List of medicines in the National List of Essential Medicines (NLEM) earlier
notified in 1996. The revised list was notified as NLEM, 2003. In November 2004, the
Government also set up a Task Force under the Chairmanship of Principal Advisor, Planning
Commission, Dr. Pronab Sen to look into the issue of price control, options other than price
control, and other issues and to make recommendations for making available life saving
drugs at reasonable prices. The basis of drugs to be considered was the NLEM, 2003, which is
the latest list at that time. The Pronab Sen Committee submitted its recommendations in
September, 2005. In 2011, the Ministry of Health revised the NLEM and notified the new
NLEM, 2011.
A need was felt to revise the Drug Policy, 1994 to meet the challenges brought about by
the competitive international pharmaceutical industry in a globalised economic environment,
as much as meeting the country’s requirements for safe and quality medicines at reasonable
prices. Therefore, the Government enunciated the National Pharmaceuticals Pricing Policy,
2012 (NPPP-2012) which replaced the Drug Policy enunciated in September 1994.
8.3 OBJECTIVES OF THE DPCO ACT
1. To regulate the equitable distribution of essential bulk drugs.
2. To fix the maximum retail prices of essential bulk drugs and drug formulations.
The DPCO has the following classes of schedules of drugs:
Schedule I: It contains the list of essential bulk drugs that are included in 27 different
sections of National list of Essential Medicines (NLEM), 2011 rule.
Pharmaceutical Jurisprudence 8.3 National Pharmaceutical Pricing Authority

Schedule II: It contains various forms for the approval, fixation or revision of prices of
Scheduled formulations.
Schedule III: It specifies the maximum pre-tax return on the sales turnover of
manufacturers or importers of formulations.
8.4 DEFINITIONS
Bulk Drug means any pharmaceutical, chemical, biological or plant product including its
salts, esters, stereo-isomers and derivatives, conforming to pharmacopoeial or other
standards specified in the Second Schedule to the Drugs and Cosmetics Act, 1940, and which
is used as such or as an ingredient in any formulation.
Ceiling Price means a price fixed by the Government for Scheduled formulations.
Dealer means a person carrying on the business of purchase or sale of drugs, whether as
a wholesaler or retailer and whether or not in conjuction with any other business, and
includes his agent.
Distributor means a distributor or his agent or a stockist appointed by a manufacturer or
an importer for stocking his drugs for sale to a dealer.
Free Reserve means a reserve created by appropriation of profits, but does not include
reserves provided for contingent liability, disputed claims, goodwill, regulation and other
similar reserves.
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 the 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, 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 Government
by notification in the Official Gazette.
(iii) Bulk drugs and formulations.
Formulation means a medicine processed out of, or containing one or more bulk drug
or drugs with or without the use of any pharmaceutical aids, for internal or external use for or
in the diagnosis treatment, mitigation and prevention of disease in human beings or animals,
but shall not include:
(i) Any medicine included in any bonafide Ayurvedic (including Siddha) or Unani (Tibb)
system of medicines.
(ii) Any medicine included in the Homoeopathic system of medicine; and
(iii) Any substance to which the provisions of the Drugs and Cosmetics Act, 1940 does
not apply.
Import means bringing into India from a place outside India, and importer in relation to
any goods at any time between their importation and consumption, includes any owner or
any person holding himself out to be the importer.
Pharmaceutical Jurisprudence 8.4 National Pharmaceutical Pricing Authority

Manufacture includes any process or part of a process for making altering, finishing,
packing, labeling, breaking or otherwise treating or adapting any drug with a view to its sale
and distribution, but does not include the compounding or dispensing of any drug or the
packing of any drug in the ordinary course of retail business.
Manufacturer means any person who manufactures a drug.
Net-worth means the paid-up share capital of a company plus free reserve, if any, and
surpluses excluding outside investments which are not readily available for operational
activity.
Non-scheduled Bulk Drug means a bulk drug not specified in the First Schedule.
Non-Scheduled Formulation means a formulation not containing any bulk drug
specified in the First Schedule.
Pre-tax Return means profit before payment of income tax and surtax includes such
other expenses as do not form of the cost of formulation.
Retail Price means the retail price of a drug arrived at or fixed in accordance with the
provisions of this order and includes a ceiling price.
Retailer means a dealer carrying on the retail business of sale of drugs to customers.
Sale Turn-over means the product or units of formulations sold by a manufacturer or an
importer, as the case may be, in an accounting year multiplied by retail price inclusive of
sales tax, if any, paid on direct sales by the manufacturer or importer, but does not include
excise duty and local taxes, if any.
Scheduled Bulk Drug means a bulk drug specified in the First Schedule.
Scheduled Formulation means a formulation containing any bulk drug specified in the
First Schedule either individually or in combination with other drugs, including one or more
than one drug or drugs not specified in the First Schedule except single ingredient
formulation based on bulk drugs specified in the First schedule and sold under the generic
name.
Wholesaler means a dealer or his agent or a stockiest appointed by a manufacturer or
an importer for the sale of his drugs to a retailer, hospital, dispensary, medical, educational or
research institution purchasing bulk quantities of drugs.
8.5 SALE PRICES OF BULK DRUGS
The Government may fix from time to time, by notification in the Official Gazette, the
maximum sale price at which any bulk drug specified in the First Schedule can be sold. No
person can sell a bulk drug at a price exceeding the fixed price plus local taxes if any.
Any manufacturer who commences the production of any bulk drug specified in the First
Schedule, after the commencement of this order, is required to furnish the necessary details
in Form I within fifteen days of the commencement of the production of such bulk drug to
the Government. The Government may then, after making the necessary inquiries, fix the
maximum sale price of the bulk drug by notification in the Official Gazette.
Any manufacturer, who desires revision of the maximum sale price of a bulk drug, should
make application to the Government in Form I. The Government shall then, within four
months from date of receipt of the complete information, fix a revised price for such bulk
drug or reject application for reasons to be recorded in writing.
Pharmaceutical Jurisprudence 8.5 National Pharmaceutical Pricing Authority

Every manufacturer of a Scheduled bulk drug or a non-Scheduled bulk drug has to

submit to the Government a list of all bulk drugs produced by him indicating the details of
the cost of each bulk drug within thirty days of the commencement of this Order and by
30th September thereafter every year.
The government may, in public interest, fix or revise the price of any non-Scheduled bulk
drug and the manufacturer or importer of such bulk drug shall not sell the same at a price
exceeding the price so fixed or revised, within fifteen days of receipt of the order.
8.5.1 Calculation of Retail Price of Formulations
The retail price of a formulation can be calculated in accordance with the following
formula,
R.P. = (M.C. + C.C. + P.M. + P.C.) × (1 + MAPE/100) + E.D.
where R.P. means retail price;
M.C. means material cost and includes the cost of drugs and other pharmaceutical
aids used including overages, if any, plus process loss thereon specified as a norm
from time to time by notification in the Official Gazette in this behalf;
C.C. means conversion cost worked out in accordance with established procedures
of costing and shall be fixed as a norm every year by notification in the Official
Gazette in this behalf;
P.M. means the cost of the packing material used in the packing of concerned
formulation, including process loss, and shall be fixed as a norm every year by
notification in the Official Gazette in this behalf;
P.C. means packing charges worked out in accordance with the established
procedures of costing and shall be fixed as a norm every year by notification in the
Official Gazette in this behalf;
MAPE (Maximum Allowable Post-manufacturing Expenses) means all costs
incurred by the manufacturer from the stage of ex-factory cost to retailing and
includes trade margin for the manufacturer and it shall not exceed 100 per cent
for indigenously manufactured Scheduled formulations;
E.D. means Excise duty.
Provided that in the case of an imported formulation, the landed cost shall form the basis
for fixing its price along with such margin to cover selling and distribution expenses including
interest and importer's profit which shall not exceed 50 per cent of the landed cost. For the
purpose of this provision, Landed Cost means the cost of import of formulation inclusive of
customs duty and clearing charges.
8.5.2 Pricing of the Scheduled Formulations Covered under Drugs (Prices
Control) Order, 1995
The prices of scheduled formulations, which are also specified in the First Schedule to the
Drugs (Prices Control) Order, 1995, fixed and notified under the provisions of the said order,
up to 31st May 2012, shall remain effective up to 30th May, 2013 and the manufacturers may
revise the prices of such scheduled formulations as per the annual wholesale price index for
the previous calendar year announced by Department of Industrial Promotion and Policy.
Pharmaceutical Jurisprudence 8.6 National Pharmaceutical Pricing Authority

The prices of scheduled formulations, which are specified in the Drugs (Prices Control)
Order, 1995 but not specified in the First Schedule of this Order, fixed and notified under the
provisions of the said order, up to 31st May 2012, shall remain effective for further one year
i.e. 30th May, 2013 and thereafter prices of such formulations shall be regulated as in case of
other non-scheduled formulations as stated in paragraph 20 of this Order.
8.5.3 Ceiling Price or Retail Price of a Pack
The average price to retailer shall be calculated on the dosage basis, (per tablet, per
capsule or injection in volume as listed in First Schedule) and the ceiling price or retail price
of a pack shall be reached by multiplying the same with the number or quantity in the pack,
as the case may be.
In the event of the unit of the dosage for a scheduled formulation not available in the
First Schedule, the lowest pack size for that category of medicine, as specified in the Drugs
and Cosmetics Act, 1940 and the rules there under, shall be taken as unit dosage for
calculating the ceiling price or retail price as the case may be, for that scheduled formulation
and this shall be applicable while calculating the per unit price of even non-scheduled
medicines for arriving at the retail price.
8.6 PRICE OF FORMULATIONS (BRANDED OR GENERIC) LISTED IN THE
NLEM LAUNCHED BY A MANUFACTURER
A manufacturer, launching a scheduled formulation, shall be free to fix the price of the
scheduled formulation equal to or below the ceiling price fixed for that scheduled
formulation by the Government. Where an existing brand is re-launched by another
manufacturer, the provisions of paragraph 13 shall be applicable.
Price of Scheduled Formulations for the Existing Manufactures:
All the existing manufactures of scheduled formulations, selling the branded or generic
or both the versions of scheduled formulations at a price higher than the ceiling price (plus
local taxes as applicable) so fixed and notified by the Government, shall revise the prices of
all such formulations downward not exceeding the ceiling price (plus local taxes as
applicable).
Provided that, in case of scheduled formulations produced or available in the market
before the date of notification of ceiling price, the manufacturers shall ensure within a period
of 45 days of the date of such notification that the MRP of such scheduled formulation does
not exceed the ceiling price (plus local taxes as applicable).
All the existing manufactures of scheduled formulations, selling the branded or generic
or both the versions of scheduled formulations at a price lower than the ceiling price (plus
local taxes as applicable) so fixed and notified by the Government shall maintain their
existing MRP.
Fixation of Ceiling Price of Scheduled Formulations:
The Government shall fix and notify the ceiling prices of the scheduled formulations in
accordance with the provisions of paragraphs 4 and 6, and no manufacturer shall sell the
scheduled formulations at a price higher than the ceiling price (plus local taxes as applicable)
so fixed and notified by the Government.
Pharmaceutical Jurisprudence 8.7 National Pharmaceutical Pricing Authority

Where any manufacturer sells a scheduled formulation at a price higher than the ceiling
price (plus local taxes as applicable) fixed and notified by the Government, such
manufacturers shall be liable to deposit the overcharged amount along with interest thereon
from the date of such overcharging.
Fixation of the Retail Price of a New Drug for Existing Manufacturers of Scheduled
Formulations:
The Government shall form a Committee of Experts to recommend the retail prices of
new drugs on the principles of "Pharmacoeconomics".
Where an existing manufacturer of a drug with dosages and strengths as specified in
NLEM launches a new drug, such existing manufacturers shall apply for prior price approval
of such new drug from the Government in Form-I under Schedule-II of this Order.
On receipt of application, in the event of the new drug not available in domestic market,
the Government shall fix the retail price of the new drug in accordance while in the event of
new drug not available in domestic market, the Government shall forward the same to the
Standing Committee of Experts who shall examine the application on the principles of
"Pharmacoeconomics" and make recommendations of retail price of the new drug to the
Government within 30 days of the receipt of application.
The Government shall, on receipt of the recommendation of the Standing Committee of
Experts fix the retail price of such new drug and such price shall be applicable to such
applicant of such new drug.
Where existing manufacturer of scheduled formulation fails to apply for prior approval of
the price of the new drug in Form-I, such manufacturer shall be liable to deposit the
overcharged amount over and above such price fixed and notified by the Government, if any,
along with interest thereon from the date of launch of the new drug, in addition to the
penalty.
8.7 NATIONAL LIST OF ESSENTIAL MEDICINES, 2011
Section 1: Anesthesia.
1.1 General Anesthetics and Oxygen - Ether, Halothane with vaporizer, Isoflurane,
Ketamine Hydrochloride, Nitrous Oxide, Oxygen, Thiopentone Sodium, Sevoflurane,
Propofol
1.2 Local Anesthetics - Bupivacaine Hydrochloride, Lignocaine Hydrochloride, Lignocaine
Hydrochloride + Adrenaline, EMLA cream
1.3 Preoperative Medication and Sedation for Short Term Procedures- Atropine Sulphate,
Diazepam, Midazolam, Morphine Sulphate, Promethazine
Section 2: Analgesics, Antipyretics, Non-steroidal Anti-inflammatory Medicines, Medicines
used to treat Gout and Disease Modifying Agents used in Rheumatoid Disorders.
2.1 Non-Opioid Analgesics, Antipyretics and Non-steroidal Anti-inflammatory Medicines-
Acetyl Salicylic Acid, Diclofenac, Ibuprofen, Paracetamol
2.2 Opioid Analgesics - Morphine Sulphate, Tramadol, Fentanyl
2.3 Medicines used to treat Gout - Allopurinol, Colchicine
2.4 Disease modifying agents used in Rhcumatoid disorders - Azathioprine,
Methotrexate, Sulfasalazine, Hydroxychloroquine phosphate, Leflunomide
Pharmaceutical Jurisprudence 8.8 National Pharmaceutical Pricing Authority

Section 3: Antiallergics and Medicines used in Anaphylaxis - Adrenaline Bitartrate,

Chlorpheniramine Maleate, Dexchlorpheniramine Maleate, Dexamethasone, Hydrocortisone
Sodium Succinate, Pheniramine Maleate, Prednisolone, Promethazine, Cetrizine
Section 4: Antidotes and Other Substances used in Poisoning
4.1 Non-specific - Activated Charcoal
4.2 Specific - Atropine Sulphate, Specific Antisnake venom, Calcium gluconate,
Desferrioxamine mesylate, Methylthioninium chloride (Methylene blue),
Penicillamine, Dimercaprol, Flumazenil, Sodium Nitrite, Sodium Thiosulphate,
Naloxone, Pralidoxime Chloride (2-PAM), N acetylcysteine
Section 5: Anticonvulsants/Antiepileptics
Carbamazepine, Diazepam, Magnesium sulphate, Phenobarbitone, Phenytoin Sodium,
Sodium Valproate, Lorazepam
Section 6: Anti-infective Medicines
6.1 Anthelminthics
6.1.1 Intestinal Anthelminthics - Albendazole, Piperazine
6.1.2 Antifilarials - Iethylcarbamazine citrate
6.1.3 Antischistosomals and Antitrematode Medicines - Praziquantel
6.2 Antibacterials
6.2.1 β lactam medicines - Amoxicillin, Ampicillin, Bezathine, Benzylpenicillin,
Cefotaxime, Cefriaxone, Cephalexin, Cloxacillin, Amoxicillin + Clavulinic acid
6.2.2 Other antibacterials - Amikacin, Azitromycin, Ciprofloxacin chloride,
Co-Trimoxazole, (Doxycycline, Eryihromycin Estolate, Gentamicin,
Metronidazole, Nitrofurantoin, Sulphadiazine, Vancomycin Hydochloride
6.2.3 Antileprosy medicines - Clofazimine, Dapsone, Rifampicin
6.2.4 Antitubercular medicines - Ethambutol, Isoniazid, Ofloxacin, Pyrazinamide,
Rifampicin, Streptomycin Sulphate
6.3 Antifungal medicines - Griseofulvin, Nystatin, Amphotericin B, Clotrimaxole,
Fluconazole
6.4 Antiviral medicines
6.4.1 Antiherpes medicines - Acyclovir
6.4.2 Antiretroviral medicince -
6.4.2.1 Nucleoside reverse transcriptase inhibitors - Didanosine, Lamivudine,
Lamivudine + Nevirapine + Stavudine Lamivudine + Zidovudine,
Stavudine, Zidovudine, Stavudine + Lamivudine, Zidovudine +
Lamivudine + Nevirapine
6.4.2.2 Non-nucleoside reverse transcriptase inhibitors - Efavirenz,
Nevirapine
6.4.2.3 Protease inhibitors - Indinavir, Nelfinavir, Ritonavir, Saquinavir
6.5 Antiprotozoal Medicines
6.5.1 Antiamoebic and Antigiardiasis medicines - Diloxanide Furoate,
Metronidazole
Pharmaceutical Jurisprudence 8.9 National Pharmaceutical Pricing Authority

6.5.2 Antileishmaniasis medicines - Amphotericin B, Pentamidine Isothionate,

Sodium Stibogluconate
6.5.3 Antimalarial Medicines
6.5.3.1 For curative treatment - Artesunate (To be used only in combination
with Sulfadoxine + Pyrimethamine), Chloroquine phosphate,
Primaquine, Pyrimethamine, Quinine sulphate, Clindamycin
6.5.3.2 For prophylaxis - Mefloquine
6.5.4 Anti Pneumo Cystosis and Anti Toxoplasmosis medicines - Co-Trimoxazole
(Trimethoprim + Sulphamethoxazole), Pentamidine Isothionate
Section 7: Anti migraine medicines
7.1 For treatment of acute attack - Paracetamol, Acetyl Salicylic Acid, Dihydroergotamine,
7.2 For Prophylaxis - Propranolol hydrochloride
Section 8: Antineoplastic, immunosuppressives and medicines used in palliative cure
8.1 Immunosuppressive medicines - Azathioprine, Cyclosporine
8.2 Cytotoxic medicines - Actinomycin D, Alpha Interferon, Bleomycin, Busulphan,
Cisplatin, Cyclophosphamide, Cytosine arabinoside, Danazol, Doxorubicin, Etoposide,
Flutamide, 5-Fluorouracil, Folinic Acid, Gemcitabine hydrochloride, L-Asparaginase,
Melphalan, Mercaptopurine, Methotrexate, Mitomycin-C
8.3 Hormones and antihormones - Prednisolone, Raloxifene, Tamoxifen Citrate
8.4 Medicines used in palliative care - Morphine Sulphate, Ondansetron, Filgrastim,
Allopurinol
Section 9: Antiparkinsonism medicines
Bromocriptine, Mesylate, Levodopa + Carbidopa, Trihexyphenidyl Hydrochloride
Section 10: Medicines affecting the blood
10.1 Antianaemia medicines - Cyanocobalamin, Ferrous Sulphate/Fumrate, Folic Acid,
Iron Dextran, Pyridoxine
10.2 Medicines affecting coagulation - Heparin Sodium, Protamine sulphate,
Phytomenadione, Warfarin sodium, Enoxaparin
Section 11: Blood products and Plasma substitutes
11.1 Plasma Substitutes - Dextran-40, Dextran-70, Fresh frozen plasma, Hydroxyethyl
Starch (Hetastarch), Polygeline
11.2 Plasma fractions for specific use - Albumin, Cryoprecipitate, Factor VIII,
Concentrate Factor IX Complex (Coagulation Factors II, VII, IX, X), Platelet Rich
Plasma
Section 12: Cardiovascular medicines
12.1 Antianginal medicines - Acetyl salicylic acid, Diltiazem, Glyceryl Trinitrate,
Isosorbide 5 Mononitrate/Dinitrate, Metoprolol, Clopidogrel
12.2 Antiarrhythmic medicines - Adenosine, Amiodarone, Diltiazem, Esmolol,
Lignocaine Hydrochloride, Procainamide Hydrochloride, Verapamil
12.3 Antihypertensive medicines - Losartan Potassium, Methyldopa, Nifedipine,
Sodium Nitroprusside, Hydrochlorthiazide Amlodipine, Atenolol, Enalapril
Maleate
Pharmaceutical Jurisprudence 8.10 National Pharmaceutical Pricing Authority

12.4 Medicines used in heart failure - Digoxin, Dobutamine, Dopamine Hydrochloride

12.5 Antithrombotic medicines - Acetyl Salicylic Acid, Heparin Sodium, Streptokinase,
Urokinase
12.6 Hypolipidemic Medicines - Atorvastatin
Section 13: Dermatological medicines (Topical)
13.1 Antifungal medicines - Miconazole
13.2 Antiinfective medicines - Framycetin Sulphate, Methylrosanilinium Chloride
(Gentian Violet), Neomycin + Bacitracin, Povidone Iodine, Silver Sulphadiazine,
Acyclovir
13.3 Antiinflammatory and antipruritic medicines - β-methasone, Dipropionate,
Calamine
13.4 Astringent Medicines - Zinc Oxide
13.5 Medicines affecting skin differentiation and proliferation - Dithranol, Glycerin,
Salicylic Acid, Coal Tar
13.6 Scabicides and Pediculicides - Benzyl Benzoate, Permethrin
Section 14: Diagnostic agents
14.1 Ophthalmic medicines - Fluorescein, Lignocaine, Tropicamide
14.2 Radiocontrast media - Barium Sulphate, Iopanoic Acid, Meglumine Iothalamate,
Meglumine Iotroxate, Propyliodone, Sodium Iothalamate, Sodium Meglumine,
Diatrizoate
Section 15: Disinfectants and antiseptics
15.1 Antiseptics - Acriflavin + Glycerin, Benzoin Compound, Cetrimide, Chlorhexidine,
Ethyl Alcohol 70%
15.2 Disinfectants - Bleaching Powder, Formaldehyde Solution, Glutaraldehyde,
Potassium Permanganate
Section 16: Diuretics - Furosemide, Hydrochlorothiazide, Mannitol, Spironolactone
Section 17: Gastrointestinal medicines
17.1 Antacids and other Antiulcer medicines- Aluminium Hydroxide + Magnesium
Hydroxide, Omeprazole, Ranitidine, Pantoprazole, Famotidine
17.2 Antiemetics - Omperidone, Metoclopramide, Promethazine, Ondansetron
17.3 Antiinflammatory medicines - 5-Amino Salicylic Acid (5-ASA)
17.4 Antispasmodic medicines - Dicyclomine Hydrochloride, Hyoscine Butyl Bromide
17.5 Laxatives - Bisacodyl, Ispaghula
17.6 Medicines used in Diarrhorea
17.6.1 Oral dehydration salts - Oral Rehydration Salts
17.6.2 Antidiarrhoeal medicines - Zinc Sulfate
Section 18: Hormones, other endocrine medicines and contraceptives
18.1 Adrenal hormones and synthetic substitutes - Dexamethasone, Hydro-
cortisone, Sodium Succinate, Methyl Prednisolone, Prednisolone
18.2 Androgens - Testosterone
18.3 Contraceptives
Pharmaceutical Jurisprudence 8.11 National Pharmaceutical Pricing Authority

18.3.1 Hormonal Contraceptives - Ethinyl Estradiol + Levonorgesterol,

Ethinylestradiol + Norethisterone, Hormone Releasing IUD
18.3.2 Intrauterine devices - IUD containing Copper
18.3.3 Barrier methods - Condoms
18.4 Estrogens Ethinylestradiol
18.5 Medicines used in diabetes mellitus
18.5.1 Insulins and other Antidiabetic agents - Glibenclamide, Insulin Injection
(Soluble), Intermediate Acting (Lente/NPH Insulin), Metformin, Premix
Insulin 30:70 Injection
18.5.2 Medicines used to treat hypoglycemia - glucagon, 25% Dextrose
18.6 Ovulation Inducers - Clomiphene Citrate
18.7 Progestogens - Medroxy Progesterone Acetate, Norethisterone
18.8 Thyroid and antithyroid medicines - Carbimazole, Levothyroxine, Iodine
Section 19: Immunologicals
19.1 Diagnostic agents - Tuberculin, Purified Protein derivative
19.2 Sera and immunoglobins - Anti-D immunoglobin (human), Polyvalent Antisnake
Venom, Antitetanus Human immunoglobin, Diphtheria Antitoxin, Rabies
immunoglobin
19.3 Vaccines
19.3.1 For Universal Immunization - C.G. Vaccine, D.P.T. Vaccine, Hepatitis B
Vaccine, Measles Vaccine, Oral Poliomyelitis vaccine (LA)
19.3.2 For Specific Group of Individuals - Rabies Vaccine, Tetanus Toxoid
Section 20: Muscle Relaxants (Peripherally acting) and Cholinesterase Inhibitors Atracurium
besylate, Neostigmine, Pyridostigmine, Succinyl Choline Chloride, Vecuronium
Section 21: Ophthalmological Preparations
21.1 Anti-infective agents - Chloramphenicol, Ciprofloxacin Hydrochloride,
Gentamicin, Miconazole, Povidone Iodine, Sulphacetamide Sodium
21.2 Antiinflammaory agents - Prednisolone Acetate, Prednisolone Sodium Phosphate
21.3 Local Anaesthetics - Tetracaine Hydrochloride
21.4 Miotics and Antiglucoma medicines- Acetazolamide, β-xolol Hydrochloride,
Pilocarpine, Timolol Maleate
21.5 Mydriatics - Atropine Sulphate, Homatropine, Phenylephrine
21.6 Ophthalmic Surgical Aids - Methyl Cellulose
Section 22: Oxytocics and Antioxytocics
22.1 Oxytocics - Methyl Ergometrine, Mifepristone, Oxytocin, Misoprosd
22.2 Antioxytocics - Terbutaline Sulphate, Nifedipine, β-methasone
Section 23: Peritoneal Dialysis Solution - Intraperitoneal Dialysis Solution
Section 24: Psychotherapeutic Medicines
24.1 Medicines used in Psychotic Disorders - Chlorpromazine hydrochloride,
Haloperidol, Olanzapinenn
24.2 Medicines used in mood disorders
Pharmaceutical Jurisprudence 8.12 National Pharmaceutical Pricing Authority

24.2.1 Medicines used in Depressive disorders - Amitriptyline, Fluozetine

hydrochloride, Imipramine
24.2.2 Medicines used in Bipolar disorders - Lithium Carbonate, Sodium
Valproate
24.3 Medicines used for Generalized Anxiety and Sleep Disorders - Alprazolam,
Diazepam
24.4 Medicines used for obsessive compulsive disorders and panic attacks - Fluoxetine
hydrochloride
Section 25: Medicines acting on the respiratory tract
25.1 Antiasthmatic medicines - Beclomethasone Dipropionate, Hydrocortisone sodium
succinate, Salbutamol sulphate, Ipratropium bromide
25.2 Antitussives - Codeine phosphate, Dextromethorphan
Section 26: Solutions correcting water, electrolyte and acid-base disturbances
26.1 Oral - Oral Rehydration Salts
26.2 Parenteral - Glucose, Glucose with sodium chloride, Normal Saline, N/2 Saline,
N/5 Saline, Potassium Chloride, Ringer Lactate, Sodium Bicarbonate
26.3 Miscellaneous - Water for Injection
Section 27: Vitamins and Minerals
Ascorbic Acid, Calcium Carbonate, Multivitamins (As per Schedule V of Drugs and
Cosmetics Rules), Nicotinamide, Pyridoxine, Riboflavin, Thiamine, Vitamin A, Vitamin D
(Ergocalciferol), Calcium gluconate.

EXERCISE
1. Discuss about the regulations of Drug Price Control Order (DPCO) Act.
2. Explain how the sale prices of bulk drugs can be fixed under DPCO Act.
3. Explain how the retail price of formulation can be fixed and calculated as per DPCO
Act.
4. Write about the fixation of ceiling and retail prices of Scheduled formulations under
DPCO Act.
5. Write the National List of Essential Medicines under DPCO Act.

BIBLIOGRAPHY
1. Agarwal SP and Khanna R, Pharmaceutical Jurisprudence and Ethics, 5th ed, reprint.
New Delhi: Birla Publications Pvt. Ltd; 2005.
2. Jain NK, A text book of Forensic Pharmacy, 8th ed, reprint. Delhi: Vallabh Prakashan;
2014.
3. Mithal BM. A Text Book of Forensic Pharmacy, 10th ed, reprint. Delhi: Vallabh
Prakashan; 1998.
✱✱✱
 UNIT V

Chapter ... 9
PHARMACEUTICAL LEGISLATIONS IN
INDIA
♦ LEARNING OBJECTIVES ♦
After completing this chapter, the reader should be able to understand:
The history of pharmaceutical legislation in India.
The recommendations of chopra committee and action taken by the government on
the recommendations.
Evolution of Bhore, Mudaliar and Hathi committees and their recommendations.

9.1 HISTORY OF PHARMACEUTICAL LEGISLATION IN INDIA

The Genesis of Modern Medicine and Pharmacy:
In ancient years, Ayurveda system of medicines was popular in India. Indians were
depending on the indigenous source of medicines. Allopathic system of medicine was
introduced to India due to the invasion of the British.
In Calcutta, the first chemist shop was introduced by Mr. Bathgate in the year 1811. It
took about 100 years to this firm to develop the first tinctures and spirits. In the year 1821,
Smith Stanistreet and Co. started a new shop and in the year 1918, the manufacturing
process was adopted by this firm. Acharya Prafulla Chandra Roy started a new company
called Bengal Chemical and Pharmaceutical works, in Calcutta in the year 1901. In 1903, the
initiative was taken by Prof. T. K. Gajjar, who established the Alembic Chemical Works Ltd. at
Baroda. All the above establishments could not satisfy the need of the population and hence
many medicines were imported to India.
After the First World War, there was a drastic change in the import of medicines. Many
cheap drugs were imported to India. The competition developed between the foreign
company drugs and indigenous drugs, as a result, many filthy practices came into picture
which resulted in the development of inferior misbranded and spurious drugs. This led to a
harmful impact on the public.
Due to the ill effects of the drug, the government of India was bound to implement
legislation pertaining to import, export, manufacture, distribution and sale of the drug. As a
result, acts like Opium Act 1878, Poison Act 1919 and Dangerous Drugs Act 1930 came into
force. These acts were insufficient for the safety of the rampant growing population and the
flourishing pharma industries. Therefore, Drug Enquiry Committee was established.

(9.1)
Pharmaceutical Jurisprudence 9.2 Pharmaceutical Legislations in India

9.2 DRUGS ENQUIRY COMMITTEE

On 11th August 1930, the Government of India, appointed The Drug Enquiry Committee
under the chairmanship of Late Col. R. N. Chopra also known as Chopra Committee to
explore the scope of the problem and to make recommendations regarding the measures.
Some of the recommendations of the Chopra committee are as follows:
• This committee developed Central and State Pharmacy council whose function was to
look after the training and education of pharmacy professionals and also maintain the
register containing the name and the address of the registered pharmacist.
• The drug control machinery departments were established at the centre in all states due
to the recommendation of this committee.
• The committee also proposed the need of well-equipped Central Drug laboratory (CDL)
with well-qualified staff and experts.
• The committee suggested appointing an advisory board to advise the government in
making rules to carry out the objectives of the Act.
• Framing the academic curculium for educating pharmacy students and also providing
training for them to become registered pharmacists.
• The committee provided a basis for registration of patent and proprietary medicines
manufactured in India or imported from outside the country.
• Inclusion of drug products used in indigenous systems and crude drugs of plant and
animal origin.
• Pharmaceutical industry development plans in India.
• The committee also suggested compiling Indian Pharmacopoeia.
Actions are taken by Government on the Chopra Committee Recommendations:
The following pharmaceutical legislation and actions of the central government can be
traced to the above said recommendations:
1. Passing Drugs Act in 1940 for regulating the import, manufacture, distribution, and
sale of drugs. The Drugs Rules were framed in 1945 to give effect to the provisons of
the Act.
2. In 1948, Pharmacy Act framed regulations for prescribing minimum educational
qualifications for the profession and practice of pharmacy.
3. Government drug testing laboratories were setup both in State and Central level.
4. Establishment of Government advisory boards such as the Drugs Technical Advisory
Board (DTAB) and Drugs Consultative Committee (DCC).
5. Drugs and Medicines of Indigenous system of medicines have been brought under
the control of Drugs and Cosmetics Act, 1940.
6. Registration of all the drugs and formulations that are sold in India.
7. Official Indian Pharmacopoeia was developed.
8. The Drugs and Magic remedies Act in 1954, Medicinal and Toilet preparations Act in
1955 and Narcotic Drugs and Psychotropic Substances (NDPS) Act in the year 1985
were implemented.
Pharmaceutical Jurisprudence 9.3 Pharmaceutical Legislations in India

9.3 HEALTH SURVEY AND DEVELOPMENT COMMITTEE

This committee was set up by Indian Government on October 1943, under the
chairmanship of Sir Joseph Bhore to make a survey of the existing position in respect of
health care delivery organization in India and to make recommendations for future
developments.
The following recommendations were made:
1. An All India Pharmaceutical Council and Provisonal Pharmaceutical Council was
established in order to represent the pharmaceutical trade, education, and other
paharmaceutical interests.
2. Enactment of legislation designed to protect the public from incompetence, to
safeguard the interests of qualified pharmacists and to raise the professional
standard of pharmacists engaged in the handling of drugs.
3. Stringnent rules were framed to control the profession and practice of pharmacy.
4. Starting of revised courses of study for:
(a) Licentiate Pharmacists,
(b) Graduate Pharmacists,
(c) Pharmaceutical Technologists,
5. Setting up of Central Drugs Laboratory.
6. Rigid enforcement of the Drugs and Cosmetics Act, 1940 thoughout the country.
9.4 MUDLIAR COMMITTEE
This committee was appointed in June 1959 under the chairmanship of
Dr. A. Lakshmanswamy Mudliar and this committee was also known as Health Survey and
Planning Committee which recommended the inclusion of indigenous systems of medicine
under the supervision of the Drugs Act. Based on its recommendations, drugs prepared
according to indigenous systems of medicine were brought within the purview of Drugs and
Cosmetics Act, 1940. The committee submitted its report of recommendations in 1961.
9.5 HATHI COMMITTEE
This committee was set up under the Chairmanship of Jaisukh Lal Hathi to implement
special provisons for the development of pharmaceutical industry in India. The report of this
committee covered all aspects ranging from licensing, price control, imports, the role of the
foreign sector, quality control etc.

EXERCISE
1. Write about the History of Pharmaceutical Legislation in India.
2. Discuss the recommendations and actions taken by Drugs enquiry committee.
3. Write about the Mudliar and Hathi Committee.
Pharmaceutical Jurisprudence 9.4 Pharmaceutical Legislations in India

BIBLIOGRAPHY
1. Agarwal SP and Khanna R, Pharmaceutical Jurisprudence and Ethics, 5th ed, reprint.
New Delhi: Birla Publications Pvt. Ltd; 2005.
2. Mithal BM, A Text Book of Forensic Pharmacy, 10th ed, reprint. Delhi: Vallabh
Prakashan; 1998.
✱✱✱
Chapter ... 10
CODE OF PHARMACEUTICAL ETHICS
♦ LEARNING OBJECTIVES ♦
After completing this chapter, the reader should be able to understand:
The meaning of Professional and Pharmaceutical Ethics.
The code of ethics of Pharmacist in relation to his job and trade,
The code of ethics of Pharmacist in relation to his and medical profession,
The Pharmacist’s Oath.

10.1 INTRODUCTION
The meaning of ethics is moral principles. It is also a science of moral duty. The code of
ethics is a carefully formulated system of principles or rules of practice for the guidance of a
particular group of individuals like the members of a profession. The development of this
code of ethics is the indication of the evolution and the growth of moral consciousness.
Ethics are different from laws. Law is defined as ‘Rules of human conduct binding on all
persons in a state or nation’. Ethics is defined as ‘Rules by which a profession regulates
actions and sets standards for all its members’. The major difference involving both of it is in
the method of enforcing compliance with the rules. When a law is broken, the violator may
be subjected to punishment, a fine or imprisonment or both or the violator may be subjected
to considerable monetary penalties in civic action. But when rules are broken, the
professional body may subject the violator to loss of professional privileges. Law may prevent
one from causing injury to another, but it cannot force him to help his neighbour in the
hours of need. Helping the neighbour is the function of ethics.
10.2 PHARMACEUTICAL CODE OF ETHICS
The profession of pharmacy is noble in its ideals and pious in its character. In handling,
selling, distribution, compounding and dispensing medical substances, including poisons and
potent drug, a pharmacist, in collaboration with medical men and others, is charged with the
onerous responsibility of safeguarding the health of people. It is the duty of all those
involved in the pharmacy field to be sure that the pharmacist in training knows the standards
of professional conduct and understands that, deviation from those standards cannot
maintain the status of the pharmacy profession.
The Government restricts the practice of pharmacy to those, who qualify under regulatory
requirements and grants them privileges necessarily denied to others. In return, the
Government expects the pharmacists to recognize their responsibilities and fulfil their
professional obligations honourably and with due regards for the well-being of the society.
Every pharmacist should, not only be willing to play his part in giving service but should also
(10.1)
Pharmaceutical Jurisprudence 10.2 Code of Pharmaceutical Ethics

avoid any act or omission which would prejudice the giving of the services or impart
confidence for the pharmacist as a body. A pharmacist must, above all, be a good citizen and
must uphold and defend the laws of the state and the nation.
Ethics of Pharmacist in Relation to his Job:
A. Scope of Pharmaceutical Services:
• When the premises are registered under statutory requirements and opened as a
pharmacy, reasonably comprehensive pharmaceutical services should be provided.
• This involves a willingness to furnish emergency supplies at all times.
B. Conduct of the Pharmacy:
• The conditions in a pharmacy should be such that it should preclude avoidable risk
or error of accidental contamination in the preparation, dispensing and supply of
medicines.
• The appearance of the pharmacy should reflect the professional character of the
pharmacy.
• It should clear to the public that, the practice of pharmacy is being carried out in the
establishment.
• Signs, notices, description, wordings on business, stationary and related indications,
should be restrained in size, design and terms.
• A notice, stating that dispensing under E.S.I.S (Employees State Insurance Scheme) or
any such other scheme sponsored by the government is carried out, may be
exhibited at the premises.
• In every pharmacy, there should be a pharmacist, in personal control of the
pharmacy who will be regarded as primarily responsible for the observance of
proper standards of conduct in connection to it.
• Any obstruction of the pharmacist in the execution of his duty by the owner will be
regarded as a failure on the part of the owner to observe the standards in question.
C. Handling of Prescriptions:
• When a prescription is presented for dispensing, it should be received by a
pharmacist without any discussion or comment over it, regarding the merits and
demerits of its therapeutic efficacy.
• The pharmacist should not even show any physiognomic expression of alarm or
astonishment upon the receipt of a prescription; as such things may cause anxiety in
patients or their agents and may even shake faith in their physician.
• Any questions that are raised related to the prescription should be answered with
every caution and care, it should neither offend a patron nor should it disclose any
information which might have been intentionally withheld from him.
• A pharmacist is not given the privilege to add, omit or substitute any ingredient or
alter the composition of a prescription, without the consent of the prescriber, unless
the change is emergent or is demanded purely by the technique of the
pharmaceutical art and does not cause any alteration in the therapeutic action of the
recipe.
Pharmaceutical Jurisprudence 10.3 Code of Pharmaceutical Ethics

• In case of any obvious error in it, due to any omission, incompatibility or over
dosage, the prescription should be referred back to the prescriber for correction or
approval of the change suggested.
• In matters related to the refilling of prescription, a pharmacist should solely be
guided by the instructions of the prescriber and he should advise patients to use
medicines or remedies, strictly in accordance with the intention of the physician, as
noted on the prescription.
D. Handling of Drugs:
• All possible care should be taken to dispense a prescription correctly, by weighing and
measuring all ingredients, in correct proportions, by the help of scales and measures;
visual estimations must be avoided.
• A pharmacist should always use drugs and medicinal preparations of standard quality.
He should never fill his prescription with spurious, substandard and unethical
preparations.
• A pharmacist should be judicious in dealing with drugs and medicinal preparations
known to be poisonous or to be used for addiction or another abusive purpose.
• Such drugs and preparations should not be supplied to any one, if there is a reason to
suppose that, it is required for such purpose.
E. Apprentice Pharmacist:
• While in charge of a dispensary, drug store or hospital pharmacy, where apprentice
pharmacists are admitted for practical training, a pharmacist should see that the
trainees are given full facilities for their work so that on the completion of their
training they acquired sufficient technique and skill to make themselves dependable
pharmacists.
• No certificate or credentials should be granted unless the above criterion is attained
and the recipient has proved himself worthy of the same.
10.3 PHARMACIST IN RELATION TO HIS TRADE
A. Price Structure:
• Price charged from the customers, should be fair and in keeping with the quality and
quantity of commodity supplied, and the labour and the skill that is required in
making it ready for use, so as to ensure an adequate remuneration to the
pharmacist, taking into consideration his knowledge, skill, time consumed and the
great responsibility involved, but at the same time without unduly taxing the
purchaser.
B. Fair Trade Practice:
• No attempts should be made to capture the business of a contemporary by cut-
throat competitions, i.e., by offering any sort of prizes or gifts or any kind of
allurement to patronisers or by knowingly charging lower prices for medical
commodities than those charged by a fellow pharmacist, if they are reasonable.
• In case, if any order or prescription, genuinely intended to be served by some
dispensary, is brought by mistake to another, then the latter must refuse to accept it
and must direct the customer to the right place.
• Labels, trademarks and other signs and symbols of the contemporary should not be
imitated or copied.
Pharmaceutical Jurisprudence 10.4 Code of Pharmaceutical Ethics

C. Purchase of Drugs:
• Drugs should always be purchased from genuine and reputable sources and a
pharmacist should always be on his guard not to aid or abet, directly or indirectly,
the manufacture, possession, distribution, and sale of spurious or substituted drugs.
D. Hawking of Drugs:
• Hawking of drugs and medicinals should not be encouraged nor should any attempt
be made to solicit orders for such substances from door to door.
• ‘Self-service’ method of operating pharmacies and drug-stores should not be used
as this practice may lead to the distribution of therapeutic substances without expert
supervision and thus would encourage self-medication, which is highly undesirable.
E. Advertising and Displays:
No display material either on the premises, in the press or elsewhere should be used by a
pharmacist in connection with the sale to the public of medicines or medical appliances
which is undignified in style or which contains: –
(a) Any wording design or illustration reflecting unfavourably on pharmacist collectively
or upon any group or individual.
(b) A disparaging reference, direct of by implication to other suppliers, products,
remedies or treatments.
(c) Misleading, or exaggerated statements or claims.
(d) The word “Cure” in reference to an ailment or symptoms of ill-health.
(e) A guarantee of therapeutic efficacy.
(f) An appeal to fear,
(g) An offer to refund the money paid.
(h) A prize, competition or similar scheme.
(i) Any reference to a medical practitioner or a hospital or the use of the terms “Doctor”
or “Dr.” or “Nurse” in connection with the name of preparation not already
established.
(j) A reference to sexual weakness, premature ageing or loss of virility.
(k) A reference to complaints of sexual nature in terms which lack the reticence proper
to the subject.
No article or preparation, advertised to the public by means of display material of a kind
mentioned above should be exhibited in a pharmacy if it is known or could reasonably be
known that the article or preparation is so advertised.
10.4 PHARMACIST IN RELATION TO MEDICAL PROFESSION
A. Limitation of Professional Activity:
• Whereas it is expected that medical practitioners, in general, would not take to the
practice of pharmacy by owning drug stores, as this ultimately leads to coded
prescriptions and monopolistic practices detrimental to the pharmaceutical
profession and also to the interest of patients.
• It should be made a general rule that pharmacists under no circumstances take to
medical practice that is to diagnosing diseases and prescribing remedies therefore
even if requested by patrons to do so.
• In cases of accidents and emergencies, a pharmacist may, however, render First Aid
to the victim.
• No pharmacist should recommend particular medical practitioner unless specifically
asked to do so.
Pharmaceutical Jurisprudence 10.5 Code of Pharmaceutical Ethics

B. Clandestine Arrangements:
• No pharmacist should enter into any secret arrangements or contract with a
physician to offer him any commission or any advantage of any description in return
for his favour of patronage by recommending his dispensary or drug store or even
his self to patients.
C. Liaison with the Public:
• Being a liaison between medical profession and people, a pharmacist should always
keep himself abreast with the modern developments in pharmacy and other allied
sciences by regularly reading books, journals, magazines and other periodicals, so
that on the one hand he may be in a position to advise the physician on
pharmaceutical matters like those of colours, flavours, vehicles and newer forms of
administration of medicines, on the other hand he may be able to educate the
people for maintaining healthy and sanitary conditions of living.
• Thus, a pharmacist can contribute his share in the nation-building activities of the
country.
• A pharmacist should at all times endeavour to promote knowledge and contribute
his quota in the advancement of learning. A pharmacist should never disclose any
information which he has acquired during his professional activities to any third
party or person unless required by law to do so.
• He should never betray the confidence which his patrons repose in him or which he
has won by virtue of his eminent character and conduct.
10.5 PHARMACIST IN RELATION TO HIS PROFESSION
A. Professional Vigilance:
• It is not only sufficient for a pharmacist to be law-abiding and to deter from doing
things derogatory to Society and his profession, but it should be his bounden duty
to make others also fulfil the provisions of the pharmaceutical and other laws and
regulations.
• He should not be afraid of bringing or causing a miscreant to be brought to book,
may be a member of his own profession.
• Whereas it is obligatory for a pharmacist to extend help and co-operation to a fellow
member in his legitimate needs, scientific, technical or otherwise, he is to be, at the
same time, vigilant to weed the undesirable out of the profession and thus help to
maintain its fair name and traditions.
B. Law-abiding Citizens:
• A pharmacist engaged in the profession has to be an enlightened citizen endowed
with a fair knowledge of the land and he should strive to countenance and defend
them. He should be particularly conversant with the enactments pertaining to food,
drug, pharmacy, health, sanitation and the like and endeavour to abide by them in
every phase of his life.
• A pharmacist is a unit whole and his life cannot be divided into compartments.
C. Relationship with Professional Organisations:
• In order to inculcate a corporate life in his own professional colleagues, a pharmacist
should join and advance the cause of all such organisations, the aims and objects of
which are conducive to the scientific moral and cultural well-being of pharmacists
and at the same time are in no way contrary to the code of pharmaceutical ethics.
Pharmaceutical Jurisprudence 10.6 Code of Pharmaceutical Ethics

D. Decorum and Propriety:

• A pharmacist should always refrain from doing all such acts and deeds which are not
in consonance with the decorum and propriety of pharmaceutical profession or
which are likely to bring discredit or upgrade to the profession or to himself.
10.6 PHARMACIST’S OATH
A young prospective pharmacist should feel no hesitation in assuming the following
Pharmacist’s Oath:
“I swear by the Code of Ethics of Pharmacy Council of India in relation to the community
and shall act as an integral part of the health care team. I shall uphold the laws and standards
governing my profession. I shall strive to perfect and enlarge my knowledge to contribute to
the advancement of pharmacy and public health.
I shall follow the system, which I consider best for pharmaceutical care and counselling of
the patient. I shall endeavor to discover and manufacture drugs if quality to alleviate the
sufferings of humanity. I shall hold in confidence, the knowledge gained about the patients in
connection with my professional practice and never divulge unless compelled to do so by the
law.
I shall associate with organizations having their objectives for the betterment of the
profession of Pharmacy and make a contribution to carry out the work of these
organizations.
While I continue to keep this oath inviolate, may it be granted to me to enjoy life and
practice of pharmacy respected by all, at all times. Should I trespass and violate the oath, the
reverse be my lot.”

EXERCISE
1. What do you mean by professional ethics? Give its significance.
2. Describe the ethics that a pharmacist should have in relation to his job.
3. Explain the code of ethics of pharmacist in relation to his and the medical
profession.
4. Write the code of ethics of pharmacist in relation to his trade.
5. Describe the Pharmacist’s Oath.

BIBLIOGRAPHY
1. Agarwal SP and Khanna R, Pharmaceutical Jurisprudence and Ethics, 5th ed, reprint.
New Delhi: Birla Publications Pvt. Ltd., 2005.
2. Jain NK, A text book of Forensic Pharmacy, 8th ed, reprint. Delhi: Vallabh Prakashan;
2014.
3. Mithal BM, A text book of Forensic Pharmacy, 10th ed, reprint. Delhi: Vallabh
Prakashan; 1998.
✱✱✱
Chapter ... 11
MEDICAL TERMINATION OF
PREGNANCY ACT
♦ LEARNING OBJECTIVES ♦
After completing this chapter, the reader should be able to understand:
The purpose and objectives of the Act.
The procedure of pregnancy termination by Medical Practitioner.
The offences and penalties of the Act.

11.1 INTRODUCTION
The Medical Termination of Pregnancy Act was passed by the parliament in 1971 with a
view to provide for termination of pregnancy by Registered Medical Practitioners for
bonafide medical reasons.
The Act extends to the whole of India except the state of Jammu and Kashmir.
The Act was framed mainly due to the following reasons:
1. Legal abortions were difficult at that time and many were being carried out illegally
under unhygienic or unsafe conditions resulting in harm to health or life of women.
2. As a population control measure since it provided for termination of unwanted
pregnancy resulting from a failure of any device or method used by the married
woman or her husband for limiting the number of children.
11.2 DEFINITIONS
(a) Guardian means a person having the care of the person of a minor or a lunatic.
(b) Lunatic has the meaning assigned to it in Section 3 of the Indian Lunacy Act, 1912.
(c) Minor means a person who, under the provisions of the Indian Majority Act, 1875 (9
of 1875), is to be deemed not to have attained his majority.
(d) Registered medical practitioner means a person who possesses any recognised
medical qualification as defined under the Indian Medical Council Act whose name

(11.1)
Pharmaceutical Jurisprudence 11.2 Medical Termination of Pregnancy Act

has been entered in a state Medical Register and who has such experience or
training in gynecology and obstetrics as may be prescribed by rules made under this
Act.
11.3 PROVISIONS OF THE ACT
The Medical Termination of Pregnancy Act provides that, pregnancies of women may be
terminated by Registered Medical Practitioners under the following circumstances:
1. Pregnancies of women, 18 years of age or more, with their consent or in case of
women who are less than 18 years of age or are lunatics, with the written consent of
their guardian.
2. A pregnancy which is not more than 12 weeks old and the medical practitioner is of
the opinion (formed in good faith) that its continuance is a grave danger to the life of
the woman or to her physical and mental health or the child to be born would be
seriously handicapped due to physical or mental abnormalities.
3. A pregnancy which is more than 12 weeks but not more than 20 weeks old, provided
that not less than two registered medical practitioners are of such an opinion.
4. A pregnancy of any duration provided that the medical practitioner is of the opinion
that such termination is immediately necessary to save the life of the pregnant
woman.
5. A pregnancy which is alleged to have been caused due to rape or due to failure of a
contraceptive device used by a woman or her husband for family planning purposes.
11.4 REQUIREMENT OF EXPERIENCE OR TRAINING FOR AN RMP TO
TERMINATE PREGNANCY
Any RMP having the following experience/training in the practice of gynecology and
obstetrics can terminate a pregnancy under the Act −
(i) If the RMP was registered in a State Medical Register before the commencement of
this Act:
(a) Experience in the practice of gynecology and obstetrics for not less than three
years.
(ii) If the RMP was registered on or after the commencement of this Act:
(a) Six months of house surgery in gynecology and obstetrics.
(b) In case, he has not done any such house surgery, experience gynecology, and
obstetrics in any hospital for not less than one year.
(c) An experience by way of assistance given by the person to an RMP in the
performance of twenty five cases of medical termination of pregnancy in a
hospital established or maintained, or a training institute approved for this
purpose, by the Government.
Pharmaceutical Jurisprudence 11.3 Medical Termination of Pregnancy Act

11.5 MAINTENANCE OF RECORDS

Records pertaining to the admissions of women for termination of pregnancy shall be
maintained by the head of the hospital or the owner of the approved place, in special
registers kept for the purpose. The entries in the register shall be made serially yearwise. The
admission register shall be a secret document and the information contained therein shall
not be disclosed to any person except as provided under the Act.
However, in case of an employed woman whose pregnancy has been terminated, the
RMP shall grant a certificate on demand in order to enable her to obtain leave from her
employer. The employer shall however not disclose this information to any other person.
No entry regarding the name or identity of the woman shall be made in any case sheet,
operation theatre register, follow-up card or any other document or register (except the
admission register). Any reference to the pregnant woman shall be made on the basis of the
serial number assigned to the woman in the admission register.
Every admission register shall be destroyed on the lapse of five years from the date of last
entry in the register. Other papers shall be destroyed on the lapse of three years from the
date of termination of the pregnancy concerned unless otherwise directed. The consent
given by the pregnant women regarding the termination of her pregnancy together with the
certified opinion of the RMP shall be sealed in an envelope by the RMP. The envelope shall
bear the serial number assigned to the pregnant woman, the name of the RMP by whom the
pregnancy was terminated and shall be marked SECRET. The envelope shall be kept in safe
custody by the head of the hospital or the owner of the approved place.
11.6 OFFENCES AND PENALTIES
The termination of a pregnancy by a person who is not a Registered Medical Practitioner
is a punishable offence under the Indian Penal Code. Any one who fails to comply with rules
made under the Act or contravenes them may be fined upto ` 1,000.

EXERCISE
1. Discuss the provisions of the Medical Termination of Pregnancy for the termination
of pregnancy.
2. Write in brief about the Medical Termination of Pregnancy Act.
3. Discuss the requirement of experience for pregnancy termination and procedure for
maintenance of records related to pregnancy termination of a woman.
4. Enlist the objectives of Medical Termination of Pregnancy Act.
Pharmaceutical Jurisprudence 11.4 Medical Termination of Pregnancy Act

BIBLIOGRAPHY
1. Agarwal SP and Khanna R, Pharmaceutical Jurisprudence and Ethics, 5th ed, reprint.
New Delhi: Birla Publications Pvt. Ltd.; 2005.
2. Jain NK, A Text Book of Forensic Pharmacy, 8th ed, reprint. Delhi: Vallabh Prakashan;
2014.
3. Mithal BM, A Text Book of Forensic Pharmacy, 10th ed, reprint. Delhi: Vallabh
Prakashan; 1998.
✱✱✱
Chapter ... 12
RIGHT TO INFORMATION (RTI) ACT
♦ LEARNING OBJECTIVES ♦
After completing this chapter, the reader should be able to understand:
The objective of RTI Act.
The composition of State and Central information commission.
The powers and functions of the State and Central information commission.

12.1 INTRODUCTION
In a democratic Republic, it is expedient to provide for furnishing certain information to
citizens who desire to have it. Democracy requires an informed citizenry and transparency of
information which are vital to its functioning and also to contain corruption and to hold
Governments and their instrumentalities. The revelation of information in actual practice is
likely to conflict with other public interests including efficient operations of the Governments,
optimum use of limited fiscal resources and the preservation of confidentiality of sensitive
information. It is necessary to harmonize these conflicting interests while preserving the
paramountey of the democratic ideal.
Right to information is guaranteed to every citizen of India under section 3 of the Right
To Information Act, 2005.
The main objective of this act is to provide for setting out the practical regime of right to
information for citizens to secure access to information under the control of public
authorities, in order to promote transparency and accountability in the working of every
public authority, the constitution of a Central Information Commission and State Information
Commissions and for matters connected therewith or incidental thereto.
12.2 DEFINITIONS
(a) "Appropriate Government" means in relation to a public authority which is
established, constituted, owned, controlled or substantially financed by funds
provided directly or indirectly (i) by the Central Government or the Union territory
administration, (ii) by the State Government;
(b) "Central Information Commission" means the Central Information Commission
constituted under sub-section (1) of Section 12;
(c) "Central Public Information Officer" means the Central Public Information Officer
designated under sub-section (1) and includes a Central Assistant Public Information
Officer designated as such under sub-section (2) of Section 5;
(d) "Chief Information Commissioner" and "Information Commissioner" means the Chief
Information Commissioner and Information Commissioner appointed under
sub-section (3) of Section 12;
(12.1)
Pharmaceutical Jurisprudence 12.2 Right to Information (RTI) Act

(e) "Competent Authority" means: (i) the Speaker in the case of the House of the People
or the Legislative Assembly of a State or a Union territory having such Assembly and
the Chairman in the case of the Council of States or Legislative Council of a State;
(ii) the Chief Justice of India in the case of the Supreme Court; (iii) the Chief Justice of
the High Court in the case of a High Court; (iv) the President or the Governor, as the
case may be, in the case of other authorities established or constituted by or under
the Constitution; (v) the administrator appointed under article 239 of the
Constitution;
(f) "Information" means any material in any form, including records, documents,
memos, e-mails, opinions, advices, press releases, circulars, orders, logbooks,
contracts, reports, papers, samples, models, data material held in any electronic form
and information relating to any private body which can be accessed by a public
authority under any other law for the time being in force;
(g) "Prescribed" means prescribed by rules made under this Act by the appropriate
Government or the competent authority, as the case may be;
(h) "Public authority" means any authority or body or institution of self government
established or constituted— (a) by or under the Constitution; (b) by any other law
made by Parliament; (c) by any other law made by State Legislature; (d) by
notification issued or order made by the appropriate Government, and includes any
(i) body owned, controlled or substantially financed; (ii) non-Government
organization substantially financed, directly or indirectly by funds provided by the
appropriate Government;
(i) "Record" includes: (a) any document, manuscript, and file; (b) any microfilm,
microfiche and facsimile copy of a document; (c) any reproduction of image or
images embodied in such microfilm (whether enlarged or not); and (d) any other
material produced by a computer or any other device;
(j) "Right to information" means the right to information accessible under this Act
which is held by or under the control of any public authority and includes the right
to: (i) inspection of work, documents, records; (ii) taking notes, extracts or certified
copies of documents or records; (iii) taking certified samples of material;
(iv) obtaining information in the form of diskettes, floppies, tapes, video cassettes or
in any other electronic mode or through printouts where such information is stored
in a computer or in any other device;
(k) "State Information Commission" means the State Information Commission
constituted under sub-section (1) of Section 15;
(l) "State Chief Information Commissioner" and "State Information Commissioner"
means the State Chief Information Commissioner and the State Information
Commissioner appointed under sub-section (3) of Section 15;
(m) "State Public Information Officer" means the State Public Information Officer
designated under sub-section (1) and includes a State Assistant Public Information
Officer designated as such under sub-section (2) of section 5;
(n) "Third party" means a person other than the citizen making a request for
information and includes a public authority.
Pharmaceutical Jurisprudence 12.3 Right to Information (RTI) Act

12.3 RIGHT TO INFORMATION AND OBLIGATIONS OF PUBLIC

AUTHORITIES
Every public authority shall maintain all its records duly catalogued and indexed in a
manner and the form which facilitates the right to information under this Act and ensure that
all records that are computerized are, within a reasonable time and subject to availability of
resources, computerized and connected through a network all over the country on different
systems so that access to such records is facilitated.
Every public authority shall, within one hundred days of the enactment of this Act,
designate as many officers as the Central Public Information Officers or State Public
Information Officers, as the case may be, in all administrative units or offices under it as may
be necessary to provide information to persons requesting for the information under this Act.
In sub-section 3 of section 8, a duty is cast on the public authority to provide information
regarding any occurrence, event or matter that has happened 20 years before the date of the
request for supply of information. This implies that, authorities are under obligation to
maintain the information or records of last and for the next 20 years in such a manner so as
to facilitate the enforcement of the RTI Act.
A person, who desires to obtain any information under this Act, shall make a request in
writing or through electronic means in English or Hindi or in the official language of the area
in which the application is being made, accompanying such fee as may be prescribed, to
(a) the Central Public Information Officer or State Public Information Officer, as the case may
be, of the concerned public authority; (b) the Central Assistant Public Information Officer or
State Assistant Public Information Officer, as the case may be; specifying the particulars of
the information sought by him or her.
An applicant making request for information shall not be required to give any reason for
requesting the information or any other personal details except those that may be necessary
for contacting him. Information shall ordinarily be provided in the form in which it is sought
unless it would disproportionately divert the resources of the public authority or would be
detrimental to the safety or preservation of the record in question.
Information that may be Refused:
There shall be no obligation to give any citizen,
(a) Information, disclosure of which would prejudicially affect the sovereignty and
integrity of India, the security, strategic, scientific or economic interests of the State,
relation with foreign State or lead to incitement of an offence;
(b) The information which has been expressly forbidden to be published by any court of
law constitute contempt of court; or tribunal or the disclosure of which may
constitute contempt of court;
(c) Information, the disclosure of which would cause a breach of privilege of Parliament
or the State Legislature;
(d) Information including commercial confidence, trade secrets or intellectual property,
the disclosure of which would harm the competitive position of a third party, unless
the competent authority is satisfied that larger public interest warrants the
disclosure of such information;
Pharmaceutical Jurisprudence 12.4 Right to Information (RTI) Act

(e) The information available to a person in his fiduciary relationship, unless the
competent authority is satisfied that the larger public interest warrants the
disclosure of such information;
(f) Information received in confidence from foreign Government;
(g) Information, the disclosure of which would endanger the life or physical safety of
any person or identify the source of information or assistance given in confidence
for law enforcement or security purposes;
(h) The information which would impede the process of investigation or apprehension
prosecution of offenders;
(i) Cabinet papers including records of deliberations of the Council of Ministers,
Secretaries and other officers;
(j) Information which relates to personal information, the disclosure of which has no
relationship to any public activity or interest, or which would cause unwarranted
invasion of the privacy of the individual unless the Central Public Information Officer
or the State Public Information Officer or the appellate authority, as the case may be,
is satisfied that the larger public interest justifies the disclosure of such information.
12.4 THE CENTRAL INFORMATION COMMISSION
The Central Government shall, by notification in the Official Gazette, constitute a body to
be known as the Central Information Commission to exercise the powers conferred on, and
to perform the functions assigned to, it under this Act.
The Central Information Commission shall consist of:
(a) The Chief Information Commissioner; and
(b) Such number of Central Information Commissioners, not exceeding ten, as may be
deemed necessary.
The Chief Information Commissioner and Information Commissioners shall be appointed
by the President on the recommendation of a committee consisting of:
(i) The Prime Minister, who shall be the Chairperson of the committee;
(ii) The Leader of Opposition in the Lok Sabha; and
(iii) A Union Cabinet Minister to be nominated by the Prime Minister.
The general superintendence, direction and management of the affairs of the Central
Information Commission shall vest in the Chief Information Commissioner who shall be
assisted by the Information Commissioners and may exercise all such powers and do all such
acts and things which may be exercised or done by the Central Information Commission
autonomously without being subjected to directions by any other authority under this Act.
The Chief Information Commissioner shall hold office for a term of five years from the date
on which he enters upon his office and shall not be eligible for reappointment:
Provided that, no Chief Information Commissioner shall hold office as such after he has
attained the age of sixty-five years.
12.5 THE STATE INFORMATION COMMISSION
Every State Government shall, by notification in the Official Gazette, constitute a body to
be known as the (name of the State) Information Commission to exercise the powers
conferred on, and to perform the functions assigned to, it under this Act.
The State Information Commission shall consist of:
(a) the State Chief Information Commissioner, and
Pharmaceutical Jurisprudence 12.5 Right to Information (RTI) Act

(b) such number of State Information Commissioners, not exceeding ten, as may be
deemed necessary.
The State Chief Information Commissioner and the State Information Commissioners shall
be appointed by the Governor on the recommendation of a committee consisting of:
(i) the Chief Minister, who shall be the Chairperson of the committee;
(ii) the Leader of Opposition in the Legislative Assembly; and
(iii) a Cabinet Minister to be nominated by the Chief Minister
The general superintendence, direction and management of the affairs of the State
Information Commission shall vest in the State Chief Information Commissioner who shall be
assisted by the State Information Commissioners and may exercise all such powers and do all
such acts and things which may be exercised or done by the State Information Commission
autonomously without being subjected to directions by any other authority under this Act.
The State Chief Information Commissioner and the State Information Commissioners shall
be persons of eminence in public life with wide knowledge and experience in law, science,
and technology, social service, management, journalism, mass media or administration and
governance. The State Chief Information Commissioner or a State Information Commissioner
shall not be a Member of Parliament or Member of the Legislature of any State or Union
territory, as the case may be, or hold any other office of profit or connected with any political
party or carrying on any business or pursuing any profession.
The headquarters of the State Information Commission shall be at such place in the State
as the State Government may, by notification in the Official Gazette, specify and the State
Information Commission may, with the previous approval of the State Government, establish
offices at other places in the State.
The State Chief Information Commissioner shall hold office for a term of five years from
the date on which he enters upon his office and shall not be eligible for reappointment:
Provided that, no State Chief Information Commissioner shall hold office as such after he has
attained the age of sixty-five years.
12.6 POWERS AND FUNCTIONS OF THE INFORMATION COMMISSIONS
Subject to the provisions of this Act, it shall be the duty of the Central Information
Commission or State Information Commission, as the case may be, to receive and inquire
into a complaint from any person;
(a) Who has been unable to submit a request to a Central Public Information Officer or
State Public Information Officer, as the case may be, either by reason that no such
officer has been appointed under this Act, or because the Central Assistant Public
Information Officer or State Assistant Public Information Officer, as the case may be,
has refused to accept his or her application for information or appeal under this Act
for forwarding the same to the Central Public Information Officer or State Public
Information Officer or Senior Officer specified in subsection (1) of section 19 or the
Central Information Commission or the State Information Commission, as the case
may be;
(b) Who has been refused access to any information requested under this Act;
Pharmaceutical Jurisprudence 12.6 Right to Information (RTI) Act

(c) Who has not been given a response to a request for information or access to the
information within the time limit specified under this Act;
(d) Who has been required to pay an amount of fee which he or she considers
unreasonable;
(e) Who believes that he or she has been given incomplete, misleading or false
information under this Act; and
(f) In respect of any other matter relating to requesting or obtaining access to records
under this Act. (2) Where the Central Information Commission or State Information
Commission, as the case may be, is satisfied that there are reasonable grounds to
inquire into the matter, it may initiate an inquiry in respect thereof.
The Central Information Commission or State Information Commission, as the 5 of 1908
case may be, shall, while inquiring into any matter under this section, have the same powers
as are vested in a civil court while trying a suit under the Code of Civil Procedure, 1908, in
respect of the following matters, namely:
(a) Summoning and enforcing the attendance of persons and compel them to give oral
or written evidence on oath and to produce the documents or things;
(b) Requiring the discovery and inspection of documents;
(c) Receiving evidence on affidavit;
(d) Requisitioning any public record or copies thereof from any court or office;
(e) Issuing a summons for examination of withesses or documents; and
(f) Any other matter which may be prescribed.

EXERCISE
1. Discuss the RTI Act, 2005.
2. Write about the Right to information and obligations of public authorities under the
RTI Act.
3. Discuss the constitution and functions of The Central Information Commission
enacted under the RTI Act.
4. Enlist the Powers and functions of the Information Commissions as per the RTI Act.

BIBLIOGRAPHY
1. Jain NK, A Text Book of Forensic Pharmacy, 8th ed, reprint. Delhi: Vallabh Prakashan;
2014.
2. The Right to Information Act, 2005 No. 22 of 2005.
3. https://rti.gov.in/rti-act.pdf
✱✱✱
Chapter ... 13
INTELLECTUAL PROPERTY RIGHTS
♦ LEARNING OBJECTIVES ♦
After completing this chapter, the reader should be able to understand:
The importance of Patent and Patent Act.
The procedure of getting Patent.
The concept of Intellectual Property Rights.
The importance of Trademarks, Copyright and Designs.

13.1 INTRODUCTION
Intellectual property refers to creations of the mind: inventions; literary and artistic works;
and symbols, names, and images used in commerce. Intellectual property has increasingly
assumed a vital role with the rapid pace of technological, scientific and medical innovation
that we are witnessing today. Moreover, changes in the global economic environment have
influenced the development of business models where intellectual property is a central
element establishing value and potential growth. In India, several new legislations for the
protection of intellectual property rights (IPRs) have been passed to meet the international
obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS).
13.2 PATENTS AND PATENT ACT
A patent in relation to inventions is an exclusive right granted by the Government to the
patentee, in exchange of full disclosure of his invention, for excluding others from making,
using, selling, importing the patented product or process producing that product for those
purposes.
13.2.1 Indian Patent Act
The Patent Act in India was implemented in 1970 which came into force on 20th April
1972 and extended to the whole of India. This Act was amended in March 1999 and June
2002 to meet India’s obligations under the Agreement on Trade Related Aspects of
Intellectual Property Rights (TRIPS), which forms part of the agreement establishing the
World Trade Organization (WTO).

(13.1)
Pharmaceutical Jurisprudence 13.2 Intellectual Property Rights

13.2.2 Definitions of Indian Patent Act

According to the Patents Act,
Assignee includes the legal representative of a deceased assignee, and references to the
assignee of any person include references to the assignee of the legal representative or
assignee of that person.
Controller means the Controller General of Patents, Designs and Trademarks.
Exclusive license means a license from a patentee which confers on the licensee, or on
the licensee and the persons authorised by him, to the exclusion of other persons (including
the patentee), any right in respect of the patented invention, and "exclusive license" shall be
constructed accordingly.
Food means any article of nourishment and includes any substance intended for the use
of babies, invalids or convalescents as an article of food or drink.
Invention means any new and useful:
(i) Art, process, method or manner of manufacture.
(ii) Machine, apparatus or another article.
(iii) A substance produced by the manufacturer and includes any new and useful
improvement of any of them and an alleged invention.
Medicine or Drug includes
(i) All medicines for internal or external use of human beings or animals.
(ii) All substances intended to be used for or in the diagnosis, treatment, mitigation or
prevention of diseases in human beings or animals.
(iii) All substances intended to be used for or in the maintenance of public health, or the
prevention or control of any epidemic disease among human beings or animals.
(iv) Insecticides, germicides, fungicides, weedicides and all other substances intended to
be used for the protection or preservation of plants.
(v) All chemical substances which are ordinarily used as intermediates in the
preparation or manufacture of any of the medicines or substances above referred to.
Patent means a patent granted under this Act.
Patent agent means a person for the time being registered under this Act as a patent
agent.
Patented article and Patented process means respectively an article or process in
respect of which patent is in force.
Patentee means the person for the time being entered on the register as the grantee or
the proprietor of the patent.
Inventions which are Patentable: An invention to be patentable should be technical in
nature and should meet the following criteria:
(a) Novelty: The matter disclosed in the specification is not published in India or
elsewhere before the date of filing of the patent application in India.
Pharmaceutical Jurisprudence 13.3 Intellectual Property Rights

(b) Inventive step: The invention is not obvious to a person skilled in the light of the
prior publication/knowledge/document.
(c) Industrially applicable: Invention should possess utility so that it can be made or
used in the industry.
Inventions not patentable: The following are not inventions within the meaning of this
Act and hence are not patentable.
(a) An invention which is frivolous or which claims anything obviously contrary to well
established natural laws;
(b) An invention, the primary or intended use or commercial exploitation of which
would be contrary to which causes serious prejudice to human, animal or plant life
or health or to the environment;
(c) The mere discovery of a scientific principle or formulation of or discovery of any
living thing or non-living substance occurring in nature;
(d) The mere discovery of a new form of a known substance which does not result in the
enhancement of any known efficacy of that substance or the mere discovery of any
new property or new use for a known substance or of the mere use of a known
process, machine or apparatus unless such known process results in a new product
or employs at least one new reactant;
(e) A substance obtained by a mere admixture resulting only in the aggregation of the
properties of the components thereof or a process for producing such substance;
(f) The mere arrangement, rearrangement or duplication of known devices each
functioning independently of one another in a known way;
(g) A method of agriculture or horticulture;
(h) Any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic
or other treatment of human beings or any process for a similar treatment of
animals to render them free of disease or increase their production or propagation
of plants and animals;
(i) Plants or animals in whole or any part thereof other than microorganisms but
including seeds, varieties, and species and essentially biological processes for
production or propagation of plants and animals;
(j) A mathematical or business method or a computer programme;
(k) A literary, dramatic, musical or artistic work or any other aesthetic creation
whatsoever including cinematographic works and television productions;
(l) A mere scheme or rule or method of performing mental act or method of playing
the game;
(m) A presentation of information;
(n) The topography of integrated circuits;
(o) An invention which, in effect, is traditional knowledge or which is an aggregation or
duplication of known properties of a traditionally known component or components.
Pharmaceutical Jurisprudence 13.4 Intellectual Property Rights

13.2.3 Types of Patent

Following types of patents are granted under the Act:
(i) An ordinary patent.
(ii) A patent of addition for improvement in or modification of an invention for which a
patent has already been applied for or granted.
(iii) A patent granted in respect of a convention application filled under section 135 of
the Act.
(iv) A product patent for a medicine or drug as provided by the Patents (Amendment)
Act, 1999.
13.2.4 Procedure for Getting a Patent
An application for an ordinary patent including that for a product patent may be made by
the person claiming to be the first or true inventor, his legal representative, or his assignee,
either alone or jointly with any other person. An application for a patent of addition may be
made only by the applicant for original patent to which it is an addition if the application for
the original patent is pending or by the registered proprietor of such original patent if the
patent has already been granted. A convention application may be made by any person who
has made the application for patent in respect of that invention in a convention country, or
by this assignee or his legal representative.
Every application for a patent should be for one invention only and should be made in
the prescribed form and filed in the Patent Office (Head Office at Calcutta and Branch Offices
at Chennai, Mumbai, and Delhi). If the application is made by virtue of an assignment, then
the proof of the right to make an application should be furnished. It must be stated in the
application that, the applicant is in possession of the invention and the name of the owner
claiming to be the true and first inventor must also be stated.
Every application must be accompanied by a provisional or a complete specification. A
provisional specification is a document in a prescribed form containing a description of the
essential features of the invention. A complete specification is a document drawn in a
prescribed form and contains the following:
(i) A full description of the invention and its operation or use and the method of
performance.
(ii) Disclosure of the best method of performing the invention known to the applicant
and for which he is entitled to claim protection.
(iii) A statement of claim or claims defining the scope of the invention for which
protection is sought.
Every specification, whether provisional or complete shall describe the invention and
begin with a title sufficiently indicating the subject-matter to which the invention relates.
Where an application is accompanied by a provisional specification, a complete specification
must be filed within 12 months from the date of filing of the application.
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On receiving the application for a patent along with complete specification, the Controller
shall refer it to an examiner for making a report to him in respect of:
(i) Whether the application and specification are in accordance with the requirements
of this Act and of any rules made there under.
(ii) Whether there is any lawful ground of objection to the grant of a patent under the
Act in pursuance of the application.
(iii) The result of the investigation made by him regarding anticipation of the invention
by virtue of a previous publication or prior claim.
(iv) Any other matter which may be prescribed.
The examiner to whom the application and specification relating thereto have been
referred to should ordinarily make the report to the Controller within a period of 18 months
from the date of such reference. If the report is adverse to the applicant or requires any
amendment of application, the Controller shall communicate the gist of the objections to the
applicant and give him an opportunity of being heard. The Controller is also empowered to
refuse to proceed with the application or require the application, specification or drawings to
be amended to his satisfaction.
On the acceptance of the complete specification, the Controller shall notify the applicant
and advertise in the Official Gazette the fact that the specification has been accepted and
thereupon the application and specification with the drawings if any shall be open to public
inspection.
On and from the date of advertisement of the acceptance of a complete specification till
the date of sealing of a patent, the applicant shall have the like privileges and rights as if the
patent for the invention had been sealed on the date of advertisement of acceptance of the
complete specification. However, the applicant shall not be entitled to institute any
proceedings for infringement until the patent has been sealed.
13.3 DIFFERENT IPR APPROACHES
Trade Mark:
Trade Marks Act, 1940 was the first statute law on trade marks in India, which was
replaced by the Trade and Merchandise Marks Act, 1958. Certain minor amendments were
carried out by the repealing and amending Act, 1960 and the Patents Act, 1970. The current
law of trademarks contained in the Trade Marks Act, 1999 is in harmony with two major
international treaties on the subject, namely
1. Paris Convention for protection of Industrial Property and
2. TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement.
A Trade mark is a mark capable of being represented graphically and which is capable of
distinguishing the goods and services of one person from those of others goods and services
Pharmaceutical Jurisprudence 13.6 Intellectual Property Rights

of one person from those of others as defined by the TMA 1999. It includes shapes of goods,
their packaging, and combination of colours. “Marks” means any device, brand, heading,
label, ticket, name, signature, words, letter, numerals, the shape of goods, their packaging or
any combination thereof.
Functions of Trade Marks:
• It distinguishes the product from similar ones in the market place. If a mark cannot
be relied upon to differentiate, it cannot fulfill any other role.
• Eliminates confusion and reduces product searching costs.
• It identifies the product. Products are recognized on the basis of TMs.
• It indicates the source and origin of the producer-primary function and establishes a
connection between goods and people.
• It advertises the product – investment function not merely the symbol of goodwill
but often the most effective agent for the creation of goodwill. Mark actually sells
goods.
• It guarantees and assures of a certain quality. TM is standard of quality-customer
expects that goods bearing the same mark will be of the same quality.
Different Types of Trademarks:
1. A name (including personal or surname of the applicant or predecessor in business
or the signature of the person).
2. Alphanumeric or Letters or numerals or any combination thereof.
3. Image, symbol, monograms, letters etc.
4. Sound marks in audio format.
Designs and Designs Act of 2000:
Considerable progress has been made in the field of science and technology after the
enactment of Designs Act, 1919 by the British Government in India. The Designs Act, 2000 is
meant to consolidate and amend the law related to the protection of designs and resemble
the Designs Act 1911. This act was in force since 11th may 2001 and extends to the whole of
India.
“Design” means only the features of shape, configuration, pattern, ornament or
composition of lines or colours applied to any article whether in two dimensional or three
dimensional or in both forms, by any industrial process or means, whether manual,
mechanical or chemical, separate or combined, which in the finished article appeal to and are
judged solely by the eye; but does not include any mode or principle of construction or
anything which is in substance a mere mechanical device, and does not include any trade
mark as defined in clause (v) of sub-section (1) of section 2 of the Trade and Merchandise
Marks Act, 1958 or property mark as defined in section 479 of the Indian Penal Code or any
artistic work as defined in clause (c) of section 2 of the Copyright Act, 1957.
Pharmaceutical Jurisprudence 13.7 Intellectual Property Rights

An industrial design refers to the ornamental or aesthetic aspects of an article. A design

may consist of three dimensional features, such as the shape or surface of an article, two
dimensional features such as patterns, lines or colors.
Industrial designs are applied to a wide variety of industrial products and handicrafts;
from technical and medical instruments to watches, jewelry and other luxury items; from
house wares and electrical appliances to vehicles and architectural structures from textile
design to leisure goods.
13.4 COPYRIGHT
Copyright is a legal concept, enacted by most governments. A copyright is a law that
gives the owner of a written document, musical composition, book, picture, or other creative
work, the right to decide what other people can do with it. Copyright laws make it easier for
authors to make money by selling their works. Because of copyright, a work can only be
copied if the owner of the copyright gives permission.
According to Harrods Librarians Glossary, copyright is, "A procedure whereby the
originator of a piece of intellectual Property (book, article, piece of music etc.) acquires a
series of rights over the work created, including copying, publishing, performing,
broadcasting and adaptation. According to Eric Miller, “Copyright refers to laws that regulate
the use of the work of a creator, such as an artist or author. This includes copying,
distributing, altering and displaying creative, literary and other types of work. Unless
otherwise stated in a contract, the author or creator of a work retains the copyright.”
Indian Copyright Act:
Indian government passed the copyright Act in the year 1957. Subsquently this act was
amended many times due to the influence of many international treaties for which India was
a signatory.
Copyright has its origin in the 20th century. It is a form of Intellectual property, which
deals with protecting the rights of a copyright holder.
Objectives:
1. To stop the copyright misuse.
2. To help in protecting the rights of a person who holds the copyright.
3. To encourage the authors, music composers, singers to create their original piece of
works by granting them exclusive rights.

EXERCISE
1. Define the following terms under Patents Act:
(a) Patent
(b) Invention
(c) Exclusive license
Pharmaceutical Jurisprudence 13.8 Intellectual Property Rights

2. Enlist the types of inventions which are not patentable as per Patents Act.
3. Describe the procedure for getting a patent.
4. Write about the purpose of Intellectual Property Rights.
5. Discuss the Trademarks and Designs.
6. Write a short note on Copyright and its benefits.

BIBLIOGRAPHY
1. Agarwal SP and Khanna R., Pharmaceutical Jurisprudence and Ethics, 5th ed, reprint.
New Delhi: Birla Publications Pvt. Ltd; 2005.
2. Jain NK, A Text Book of Forensic Pharmacy, 8th ed, reprint. Delhi: Vallabh Prakashan;
2014.
3. Mithal BM, A Text Book of Forensic Pharmacy, 10th ed, reprint. Delhi: Vallabh
Prakashan; 1998.
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