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Guru Jambheshwar Universitu PHARMACEUTICAL :
Telegram - Study
of SciencePharmacy
& Technology
JURISPRUDENCE
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[Fourth Revised Edition]

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LIBRARY
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Hisar (Haryana)
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Accession No. E492
N. K. JAIN
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M.Pharm., Ph.D., LL.M., F.I.C.
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Director, I.S.F. Coege of Pharmacy,

Moga (Punjab)
formerly, Professor, Head & Dean
Dept. of Pharmaceutical Science
Dr H .S. Gour University
SAGAR (M.P.)
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ary,
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SE24723
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ASAR
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Delhi
VALLABH PRAKASHAN

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Contents

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Preface to the Fourth Edition

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Preface to the First Edition
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1. Pharmaceutical Legislation in India

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Origin and 'nature of pharmaceutical legislation in India, its
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scope and objectives. Evolution of the concept of pharmacy
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as an integral part of the Health Care System.

2. Code of Pharmaceutical Ethics

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Principles and significance of professional ethics. Critical
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study of the Code of Pharmaceutical Ethics drafted by Phar-
macy Council of India.

. 3. Pharmacy Act, 1948

The general study of the Pharmacy Act with special reference
to Education Regulations, working of Central and State Coun-
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. cils, constitution of these Councils and functions. Registration

procedures under the Act.
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Drugs and Cosmetics Act, 1940 28
General study of the Drugs and Cosmetics Act and the Rules
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thereunder. Definitions and salient features related to retail
and wholesale distribution of drugs. The powers of Inspec-
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tors, the sampling procedures and the procedure and formalities
in obtaining licences under the rule. Facilities to be provided
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for running a pharmacy effectively. General study of the
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Schedules with special reference to Schedules C, C, F, 6, H,
J, P and X and. salient features of labelling and storage
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conditions of drugs.
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5. Drugs and Magic Remedies (0bjectionable Advertisements)
Act, 1954 87
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General study of the Act, objectives, special reference to be

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laid on advertisements. Magic remedies and objectionable
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and permitted advertisements - diseases which cannot be

claimed to be çured.

(vii)
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Narcotic Drugs Psychotropic Substances Act, 1985
brief study of the
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with special reference to its objec-
Act
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tives, offences and penalties.

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7. Drugs.(Prices Control) Order, 2013 107
Introduction, Definitions, Sale prices of bulk drugs, Retail
price of formulations, Power of entry, search and seizure, Pharmaceutical Legislation in India

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Penalties, List of bulk drugs (first schedule).

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8. Poisons Act, 1919 123
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Introduction, Import of poisons, Possession and sale of Introduction to jurisprudence The study of fundamental legal princi-

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poisons. Penalties. ples is called jurisprudence. In- general sense, jurisprudence includes
knowledge of the law while in technical sense it is the science of the first
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9. Medicinal and Toilet Preparations (Excise Duties) principles of civil law. Jurisprudence and ethics are related to each other.
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Act, 19555 125 Ethics is the science of human conduct. With reference to the human
Introduction, Definitions, Licensing, Manufacture in Bond, conduct there is the ideal moral code and the positive moral code. The
ideal moral code deals with the natural laws. The positive moral code deals
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Manufacture outside bond, Inter-State Transport of alcoholic
goods, Offences and Penalties with the positive or actual conduct. Jurisprudence is related to positive
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morality. Ethics lays down rules for ideal human conduct and laws are
10. Medical Termination of Pregnancy Act, 1971 132 meant for regulating human conduct. Jurisprudence serves to train the
Introduction, Definitions, Termination of pregnancies, Experi- mind into legal ways of thought and affords a key to the solution of many
ence/Training of RMP, Approval of place, Admission register, provisions of civil law.
Custody of forms A pharmacist has to be knowledgeable in his profession including the
137 legislation governing his profession. He should be familiar .with the laws
11. Consumer Protection Act governing drugs and cosmetics and other topics included in this book. In
Object, Definitions, District forum, State commission, National
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addition, the Consumer Protection Act, 1986 is also important to pharma-
consumer disputes redressal commission cists because according to the Supreme Court, medical services are covered
under the definition of service' that includes rendering of consultation,
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12. Right To Information Act 140
Introduction, Definitions, Right to information and obliga- diagnosis and treatment, both medical and surgical. Most recent legislation
that governs practicing pharmacists is the Right To Information Act.
tions of public authorities, Information that may be refused,
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The Central Information Commission, The State Information Function of law is to achieve justice, stability and peaceful changes in a
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Commission, Intelligence and security organisation estab- society.
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lished by the Central Government Pharmaceutical jurisprudence is concerned with the application of
pharmaceutical knowledge to legal problems. It is also concerned with the
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APPENDIX : List of Essential Medicines 147 laws related to drugs, medicines, cosmetics, pharmacists and pharmaceuti
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cal profession.
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REVISION QUESTIONS 151
Pharmacy and Health Care
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From the dawn of civilization, pharmacý evolved as an integral part of

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INDEX 158
the health care system. In the beginning man developed an extensive
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folklore of remedies, which were based on experience and superstition. In

(vii)
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2 PHARMACEUTICAL JURISPRUDENCE
Ch-1 PHARMACEUTICAL LEGISLATION IN INDIA
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every community certain members became specialists in the identification
and use of crude drugs from vegetable and animal sources. Earlier because health is influenced by a number of factors such as adequate food,
housing, basic sanitation, healthy lifestyles, protection

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physicians themselves used to diagnose the. diseases and treat them. against environ-
Medicine arose as an. adjunct to magic. There were no separate professions mental hazards and communicable diseases. Thus health care implies more
than medical care. It embraces. a. multitude of "services provided

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of medicine and pharnmacy as they exist today. Although pharmacy didn't individuals or communities by agents of the health services or to
exist as a separate discipline yet some physicians delegated the responsibil- professions,
ity of preparing medicines to their assistants, the apothecaries. Indian for the purpose of promoting, maintaining, or restoring
health". Health

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physicians, the priests, however, kept everything secret. In any case, care is a public right and it is the responsibility of
the Government to
medical treatment all over the world has always been associated with provide this care to all people in equal manner. Health

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services should be
religious service and ceremony. reasonably inexpensive and have the basíc essentials required
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by rural
people. Pharmacy occupies an important role in health
per records the earliest work in Hindu medicîne was the Atharvaveda care system and
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pharmacists are úniquely qualified because:
followed by Ayurveda and Rigveda. Dhanvantari, Charaka, Sushruta and
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Atrey are the great names in Hindu medicine. Charaka Samhita, a 1. they understand the principles of quality assurance as
applied to
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compendium of encyclopedia of medicine was composed by Charaka. It is medicine;
stillused in India. In the middle ages, Vagbhata (625 AD) prepareda 2. they appreciate the intricacies of the distribution chain
and the
medical compendium prose and verse and Bhava Misra (1550 AD) wrote a principles of efficient stock-keeping and stock turnover;
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book on:anatomy, physiology and medicine in which he mentioned the 3. they are familiar with the pricing structures applied to medicinal
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circulation of blood, a hundred years before Harvey. He also prescribed products that obtain within the markets in which they operate;
mercury for syphilís.
4. they are the custodians of much technical information on the
A young Scotch named Mr. Bathgate who came to India with East India products available on their domestic market;
Company opened the first Chemist shop in India in 1811 at Calcuta. This 5. they are able to provide informed advice to patients with
m atook up manufacture of minor
tinctures and spirits in. 1910. The firm of illnesses and often to those with more chronic conditions who are
Spith Stanistrèet & Co. was started in 1821 as a small apothecary shop and on established maintenance therapy; and last but not the least,
commenced its manufacturing business in 1918. They were the pioneers in
6. they provide an interface between the duties of prescribing and
the manufacture of pure alkaloids like strychnine and brucine. In the
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beginning of this century drug industry did not practically exist in India selling medicines and, in so doing, they dispose of any perceived
or potential conflict of interest between these twc functions.
and almost all the requirements of pharmaceuticals were imported mainly
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from U.K, France and Germany. The manufacture of modern drugs started This spectrum of activities identifies the dispensing of medicines
as the
by the end of 19th century Bengal Chemical and Pharmaceutical Works pivotal responsibility of the pharmaceutical services. In addition,
was established in Calcutta in 1901, and Prof T K Gaijar started a small the
distinctive expertise of the pharmacist provides members of the profession
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factory at Parel, Mumbai in 1903 and Alembic Chemical Works was started with a suitable background to assume diverse responsibilities in both public
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at Baroda in 1907. The import and export of drugs in 1908-9 amounted to administration and drug manufacture and supply. The competence of the
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Rs 73 lacs and Rs 15.5 lacs, respectively. Drugs were mostly exported in pharmacist is already proven and evident:
crude form and imported in finished form. The situation however changed
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1. in the direction and administration of pharmaceutical services:
due to the World War I. The spirit of Swadeshi gained ground and the
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2. in drug regulation and control;

markets were flooded with indigenous and imported inferior, adulterated,
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misbranded and substandard drugs. The Drugs Enquiry Committee was 3. in the formulation and quaity control of pharmaceutical products:
appointed by the Government of India and ultimately the Drugs and 4. in the inspection and assessment of drug manufacturing facilities;
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Cosmetics Act was passed in 1940 and the Pharmacy Act in 1948. Both 5. in the assurance of product quälity. throughout the distribution
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these Acts have played significant role in the evolution of pharmacy as an chain;
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integral part of the Health Care System. 6. in drug procurement agencies; and
The frontiers of health extend beyond the narrow limits of medical care 7. in national and institutional formulary committees.
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Ch-1 PHARMACEUTICAL LEGISLATLON IN INDIA
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these activities the pharmacist serves as
(health care team).
a member of a multidisciplinary
3. Appointment of an Advisory Board to advise the Government in
making rules to carry out the objects of the Act.

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The contribution of pharmacists to health care is based upon a body of 4. Setting up of courses for training in pharmacy and prescribing
knowledge and expertise acquired from his education followed by a formal minimum qualifications for registration as a pharmacist.

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period of pre-regístration practical experience. From this basic education
and pre-registration training, students acquire a broad understanding of 5. Registration of every patent and proprietary medicine of undis-
the scientific principles and techniques of the pharmaceutical sciences and closed formula manufactured in India or imported from outside the

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country.
the ability to keep pace throughout their careers with developments in

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medicine and pharmacy. Their knowledge and expertise extend to all 6. The crude single drugs as well as the compounded medicines used
aspects of the preparation, distribution, action. and use of drugs and
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inthe indigenous systems of medicine, should be brought under

medicines. control

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Community pharmacists are the health professionals most accessible to 7. The drugs industry in India should be developed.
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the public. They supply medicines in accordance with a prescription or, 8. The manufacturing in Medical Stores Depots should be gradually
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when legally permitted, sell them without a prescription. In addition to reduced.
ensuring an accurate supply of appropriate: products, their professional 9. Steps should be taken to compile an Indian Pharmacopoeia.
activities also cover counseling of patients at the time of dispensing of
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prescription and non-prescription drugs, drug information to health profes- 10. The Cinchona Department should cultivate cinchona.
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sionals, patients and the general public, and participation in health- Health Survey and Development Committee (Bhore Committee) was
promotion programmes. They maintain links with other health profession- appointed in 1943 to make a survey of the existing position in respect of
als in primary health care. health organization in the then British India and to make recommendations
for further developments. Some of the recommendations of this Committee
Drug Legislation in India ii were as follows:
Before independence there was practically no legislative control on 1. The establishment of. an All India Pharmaceutical Council and
drugs as well as on profession of pharmacy. Although Opium Act 1878, Provincial Pharmaceutical Councils representing the pharmaceutical
Poisons Act 1919 and Dangerous Drugs Act 1930, were in operation yet
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trade, éducation and other pharmaceutical interests.
they were inadequate and hence there. existed chaotic and deplorable
conditions in drugs trade and industry. Virtualy anything under the name 2. Enactment of legislation designed to protect the public from
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of drug could be made, sold or imported even though it contained no incompetence, to safeguard the interests of quálified pharmacists
therapeutic activity. In 1928 the Government of india appointed the Drugs and to raise the professional standing of pharmacists engaged in
Enquiry Committee (Chopra Committee) to examine the whole issue of the handling of drugs.
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drugs trade in India. The report of the Committee was published in 1931 3. Measures for registration of pharmacists.
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and the recommendations formed the basis for the enactment of Drugs Act 4, Measures for maintaining disciplinary control over the practice and
1940 and the Pharmacy Act, 1948. Important recommendations of the
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profession of pharmacy
Committee were as follows: 5. Revised courses of study for (i) Licentiate Pharmacists; (ii) Gradu-
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1. Central egislation to control drugs and pharmacy. The legislation ate Pharmacists; and (ii) Pharmaceutical Technologists.
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may consist of either a combined Drugs and Pharmacy Act or

6. Setting up of Central Drugs Laboratory.
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separae Drugs Act and separate Pharmacy Act.
7. The Drugs Act 1940 should. be. brought into operation throughout
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2. Setting up of test laboratories in all states to control the quality of

the country and rigidly enforced. *
production of drugs and pharmaceuticals and a control laboratory
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8. The question of requirements of the country in drugs and of the
to control the quality of imported drugs and also to act as expert
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referee in case of disputed samples sent by local Government. medical requisites should be examined by a small committee.
Pharmacy Bill was introduced by the Government of India in 1945 to
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regulate the profession of pharmacy and ultimately passed as Pharmacy Act
Ch-1 PHARMACEUTICAL LEGISLATION IN INDIA

Chopra in 1944 was significant. This Committee

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1948.Following are the salient features of the Act:- was set up with the object
to prepare the material for list of drugs in use in India. The
Indian
1The constitution of the Central and State Pharmacy Councils. Pharmacopaæial List was published in 1946.

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A full-fledged Indian
2. The prescribing of the minimum standard of education required for Pharmacopoeial Committee was appõinted in 1948 and
the first edition of
qualifying as a pharmacist. Indian Pharmacopceia was brought out in 1955 followed by second
in 1966, third edition in 1985, fourth edition in 1996,
edition

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3. The registration of the pharmacists by the State Pharmacy Councils. fifth edition in
2007, Sixth edition in 2010 and the seventh.edition is
4.Maintenance of disciplinany control over the profession of pharmacy 2014.

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In exercise of the powers under the Essential Commodities Act,
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5. Dispensing of prescriptions of registered medical practitioners only 1955

by registered pharmacists.
the Central Government pased the Drugs irices (Display
and Control)

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Order, 1966. Similarly the Drugs (Prices Coitrol) Order, 1970 was
Pharmacy. Enquiry Committee was appointed in 1953 to make a passed
which was later repealed by the Drugs (Prices Control) Order, 1979,
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comprehensive enquiry into the working of the pharmaceutical industry and 1987
and subsequently in 1994. The latest version is the Drugs (Prices
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to recommend the steps to be taken by the government to establish it on Control)
Order, 2013; in accordance with the National Pharmaceuticals
Pricing
sound ine in the interest of country's health and economy. Policy- 2012.
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Although the Drugs Act and the Rules did exist in the country yet there The National Pharmaceutical Princing Policy, 2012 provides
was no control on advertisements and therefore any false, misleading, the meas-
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ures for rationalisation, quality control and growth of drugs
obscene, fraudulent or exaggerated advertisements could be published and
. pharmaceutical industry in India.
freely.. This posed a real danger to the public health in the country. To The Narcotics Drugs and Psychotropic Substances Act
curb. this unheatthy practice in advertisements relating to drugs and 1985 was long
awaited which has repealed the outdatd legislation like
medicines, the Drugs and Magic Remedies (0bjectionable Advertisements) the Opium Act,
1857, the Opium Act 1978, and the Dangerous Drugs Act 1930.
Act was' passed in 1954. The statement of objects and reasons of the
Drugs and Magic Remedies Bill are reproduced below: The Right to Information Act as well as Consumer Protection Act are the
newer legislation affecting the pharmaceutical profession.
"In. recent years there has been a great increase in the number of
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objectionable advertisements published in newspapers or magazines or Scope and Objectives of pharmaceutical legislation
otherwise relating to alleged cures for venereal diseases, sexual stimulants As evident from the objects of various Acts
etc. main objectives of
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and alleged cures for diseases and conditions peculiar to women. These pharmaceutical legislation in India are:
advertisements tend to cause the ignorant and unwary to resort to self-
1. To promote .health care by regulating the manufacture, supply
medication with harmful drugs and appliances, or to resort to quacks who and
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indulge in such advertisements for treatments which cause great harm. It distribution of quality drugs;
2. To make these drugs available to the public at reasonable prices
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isi necessary. in the public interest to put a stop to such undesirable
advertisements. The Bill is intended for this purpose." and through qualified persons;
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Medicinal and Toilet Preparatlons (Excise Duties) Act was introduced 3. To safeguard the public from misleading advertisements etc.
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about
in: 1955 mainly to regulate the use of alcohol in medicinal and toilet drugs and remedies
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preparations. 4. To regulate the profession of pharmacy:

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In June 1959 the Government of India appointed the Health Survey and 5. To promote the indigenous research, technology and know-how in
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Planning Committee (Mudaliar Committee). Besides other recommenda- the manufacture of drugs..
tignstheCommittee recommended that it was necessary to bring drugs,
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The main thrust of pharmaceutical legistation in
India has been on
Pepared-according to indigenous system of medicine also within the
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regulating the manufacture, distribution, sale, import and export off drugs,
purview of the Drugs Act. .edicines and cosmetics; and the profession of pharmacy.
:Appointment of Chopra Committee under.the Chairmanship of Col. R N

Saa****
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of the growing complexities of life and specializations, a-set of gerera
ethics, for every walk of life, is hardly enough and there is need for

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formulating ethical codes for every sphere of activity and profession.

2 The code of ethics, formulated by the Pharmacy Council of India for

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the guidance of Indian pharmacists is reproduced below, in essential
details. It is meant to guide the pharmacist as to how he should conduct

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Code of Pharmaceutical Ethics himself in relation to himself, his patrons and the general public, co
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professionals, and members of the medical and other health professions.

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The code does not claim to contain all matters, which should be subjects
of standards of professional conduct, but deals with those upon which
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Ethics lays down rules for ideal human conduct and laws are meant for guidance is necessary.
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regulating human conduct in the present and for subordinating the
individual's requirement of society at large. Code of pharmaceutical ethics Code of Pharmaceutical Ethics
serves as moral guidance to the pharmacists in the conduct of their The profession of pharmacy is noble in its ideal and pious in its
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professional practice. character. Apart from being a career for earning livelihood, it has inherent
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This chapter is important to all pharmacists working in any discipline of in it, the attitude of service and sacrifice in the interests of suffering
humanity. In handling, selling, distributing, compounding and dispensing
the profession of pharmacy.
medical substances, including poisons and patent drugs, a pharmacist in
Introduction Ethics may be defined as 'the code of moral principles' collaboration with medical men and others, is charged with the onerous
or as 'the science of morals'. Therefore, in order to understand 'ethics one responsibility of safeguarding the health of people. As such he has to
must understand the meaning of the term 'morals. The conduct of
uphold, above all things, the interests of his patrons. The lofty ideals set
individuals in any society is govemed by the governmental controls on the up by Charaka, the ancient Indian philosopher, physician and pharmacist in
one hand and the social customs and duties on the other. The former has his enunciation: "Even if your own life be in danger you should not betray
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the sanction of the law and the latter is left to the individual and the or neglect the interests of your patients" should be fondly cherished by al
society. For this purpose, societies lay down a code of conduct to help the pharmacists.
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individuals to decide what is right and what is wrong. Such a code, when
practised by any society for a long time, results in the culture of a Government restricts the practice of pharmacy to those, wh0 qualify
conscience in the individuals, which gives them a faculty to decipher for under regulatory requirements and grants them privileges necessarily denied
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themselves, the right way of conducting their daily life, conducive to the to others. In return, the government expects the pharmacists to recognize
well being of the society. This way of conducting life is said to be the their responsibilities and to fulfil their professional obligations honourably
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ethical way and the culture of such conscience may well be termed as and with due regard for the well being of the society.
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morality. While the law of a place may prevent one from causing injury to Standards of the professional conduct for pharmacy are necessary in the
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another, it cannot force him to help his neighbour in hours of need. The public interest to ensure an efficient pharmaceutical service. Every
latter part of the job is a function of the conscience and morality.In
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pharmacist should not only be willing to play his part in giving such a
particular reference to Pharmaceutical Jurisprudence, the Drugs and Cos service but should also avoid any act or omission which would prejudice
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metics Act and Rules can prevent a pharmacist from selling drugs at higher the giving of the services or impair confidence in any respect for pharma-
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prices than those fixed under Drugs (Prices Control) Order but cannot cists as a body.
prevent him from seling his commodities at a cheaper rate than that of his
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The ture of pharmaceutical practice is such that its demands may be
fellow pharmacists in his area, or from indulging in a cut throat competi-
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beyond the capacíty of te in; ividual to cary out or to carry out as quickly
tion, which practice is as undesirable as that of selling substandard drugs. or as efficiently as the needs of the public require. There should,
Such unhealthy tendencies, which do not fall within the shadow of the law, therefore. at all times, be a readiness to assist colleagues with, information
can be guarded against only by the terms of an ethical code arrived at by or advice.
mutual consent, with a social or a moral sanction behind it. In these days
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10 PHARMACEUTICAL JURISPRUDENCE Ch-2 CODE OF PHARMACEUTICAL ETHICS 11

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of pharmacy. It should be clear to the pubiic that the practice of
pharmacist must, above all, be a good citizen and must uphold and
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pharmacy is carried out in the establishment. Signs, notices, descriptions,
wordings on business, stationery and related indications, should be re

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defend the laws of the State and the nation.
Pharmacist in Relation to His Prôfession strained in size, design and terms. Descriptions, which denote or imply
pharmaceutical qualifications should be limited to those, of which, the use

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Professional vigilance It is not sufficient for a pharmacist to be law is restricted by law and should not draw invidious distinction between
abiding and to deter from doing things derogatory to the society and his

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pharmacists. A notice, stating that dispensing under (Employees State
profession, but it should be his bounden duty to make others also fulfill
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Insurance Scheme) E.S.I.S. or any such other scheme sponsored by the

the provisions of the pharmaceutical and other laws and regulations. he Government is carried out, may be exhibited at the premises. In every

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should not be afraid of bringing or causing a miscreant to be brought to pharmacy there should be a pharmacist, in personal control of the phar-
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book, may be he is a member of his own profession. Whereas it is

macy, who will be regarded as primarily responsible for the observance of
obligatory for a pharmacist to extend help and cooperation to a fellow
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proper standards of conduct in connection with it. Any obstruction of the
member in his legitimate needs, scientific, technical or otherwise, he is to pharmacist in the execution of his duty by the owner will be regarded as
be at the same time, vigilant to weed the undesirable out of the profession failure on the part of the owner to observe the standards in question.
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and thus help to maintain its fair name and traditions.
Handling of prescriptions When a prescription is presented for dis-
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Law-abiding citizen A pharmacist, engaged in profession, has to be
in an enlightened citizen endowed with a fair knowledge of the laws of the pensing, it should be received by a pharmacist without any discussion or
comment over it, regarding the merits and demerits of its therapeutic
land and he should be partícularty conversant with the enactments pertain-
efficiency. The pharmacist should not even show any physiognomic
ing 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 expression of alarm or astonishment upon the receipt of a prescription; as
and his life cannot be divided into compartments. such things may cause anxiety in patients or their agents and may even
shake their faith in their physician. Any question on a prescription should
Relationship with professional organisations In order to inculcate a be answered with every caution and care; it should neither offend a patron
corporate life in his own professional colleagues, a pharmacist should joîn nor should it disclose any information which might have been intentionally
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and advance the cause of all such organisations, the aims and ects of
withheld from him.
which are conducive to scientific, moral and cultural well-being of pharma-
It is not within the privilege of a pharmacist to add, omit, or substitute
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cists and at the same time are in no way contrary to the code of
any ingredient or alter the composition of a prescription, without the
pharmaceutical ethics.
consent of the prescriber, unless the change is emergent or is demanded
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Decorum and propriety A pharmacist should always refrain from purely by the technique of the pharmaceutical art and does not cause
any
doing all such acts and deeds which are not in consonance with the the therapeutic action of the recipe. In case of any obvious
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alteration in
decorum and propriety of pharmaceutical profession and are likely to bring error in it, due to any omission, incompatibility or overdosage, the
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discredit or upbraid to the profession or to himself. prescription should be referred back to the prescriber for correction or
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in the
in Relation to His Job approval of the ch.ange suggested. While such an act is imperative
Pharmacist best interest of the patient, in no' case should it be done in
a manner
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Scope of pharmaceutical servicès when premises are registered under which may jeopardize the reputation of the prescriber concerned.
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statutory requirements and opened as a pharmacy, reasonably comprehen-
sive pharmaceutical services should be provided. This involves the supply In matter of refilling prescriptions, a pharmacist should solely be
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of commonly required medicines without undue delay. It also involves guided by the instructions of the prescriber and he should advise patient
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willingness to furnish emergency supplies at all times. to use medicines or remedies, strictly in accordance with the intention of
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the physician, as noted on the prescription.

Conduct of sth pharmacy The conditions in a pharmacy should be
Handling of drugs All possible care should be taken to dispense
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such as to preclude avoidable risk or error of accidental contamination in
the preparation, dispensing and supply of medicines. prescription correctly, by weighing and measuring all ingredients, in correct
The appearance of the premises should reflect the professional character
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12 PHARMACEUTICAL JURISPRUDENCE
Ch-2 CODE OF PHARMACEUTICAL ETHICS 13

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Hawking of drugs Hawking of drugs and medicinals should not be
proportions, by the help of scales and measures; visual estimations must be encouraged nor should any attempt be. made to solicit orders for such
avoided. Further, a pharmacist should always use drugs and medicinal

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substances from door to door. "Self-service' method of operating pharma-
preparations of standard quality. He should never fill his prescription with cies and drugstores should not be used, as this practice may lead to the
spurious, substandard and unethical preparations. distribution of therapeutic substances without an expert supervision and

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A pharmacist should be very judicious in dealing with drugs and would thus encourage self-medication, which is highly undesirable.
to be poisonous or to be used for addiction

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medicinal preparations known Advertising and displays No display material, either on the premises,
or another abusive purpose. Such drugs and preparations should not be
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in the press or elsewhere should be used by a pharmacist in connection

supplied to any one, if there is reason to suppose that it is required for with the sale to the public of medicines or medical appliances, which is

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such purpose. undignified in style or which contains:
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hospital pharmacy, where apprentice pharmacists are admitted for practical pharmacists collectively, or upon any group or individual
training, a pharmacist should see that the trainees are given full facilities (6) A disparaging reference, direct or by implication to other suppliers,
for their work, so that on the completion of their training they have
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products, remedies, or treatments.
acquired sufficient technique and skill to make themselves dependable
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pharmacists. No certificate or credentials should be granted, unless the (c) Misleading or exaggerated statements or claims.
above criterion is attained and the recipient has proved himself worthy of (d)The word "cure" in reference to an ailment or symptoms of ill-
same. health.
in Relation to His Trade (e) A guarantee of therapeutic efficacy.
Pharmacist i
Price structure Prices charged from customers, should be fair and in An appeal to fear.
keeping with the quality and quantity of commodity supplied, and the (g) An offer to refund money paid.
labour and skil required in making it ready for use, so as to ensure an (h) A prize, competition or similar scheme.
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adequate remuneration to the pharmacist, taking into consideration his
knowledge, skill, the time consumed and the great responsibility involved, (Any reference to medical practitioner or a hospital or the use of
the terms "Doctor" or "Dr." or "Nurse", in connection with the
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but at the same time without unduly taxing the purchaser.
name of a preparation, not already established.
Fair trade practice No attempt should be made to capture the ) A reference to sexual weakness, premature ageing or loss of virility.
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business of a contemporary by cut throat competitions, that is, by offering9 (K) A reference to complaints of sexual nature in terms, which lack the
any sort of prizes or gifts or any kind of allurement to patronizers or by
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knowingly charging lower prices for medical commodities than those reticence proper to the subject.
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charged by a fellow pharmacist, if they be reasonable. In case, any order No article or preparation, advertised to the pubtic by means of display
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or prescription, genuinely intended to be served by some dispensary, is material of a kind mentioned above, should be exhibited in a pharmacy, if
brought by mistake to another, the latter should refuse to accept it and
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it is known or could reasonably be known that the article or preparation is

should direct the customer to the right place. abels, trade marks and so advertised.
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other signs and symbols of contemporaris should not be imitated or
Contraceptive preparations and appliances or their illustrations except a
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copied.
notice approved by regulations or bearing the words "Family Planning
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Purchase of drugs Drugs should always be purchased from genuin Requisites" should not be exhibited. Under no circum ances should
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and reputable sources and a pharmacist should always be on his guard not lustful, obscene and indecent publications of any kind or description be
to aid or abet, directly or indirectly, the manufacture, possession, distribu- sold or distributed as this practice is highly detrimental to the moral
tion and sale of spurious or substandard drugs. welfare of, the nation.
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14
PHARMACEUTICAL JURISPRUDENCE
Ch-2 CODE OF PHARMACEUTICAL ETHICS 15

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I shall uphold the laws and standards governing my prófession.
Pharmacist in Relation to Medical Profession *I shall strive to perfect and enlarg my knowledge to contribute to

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Limitation of professional activity Whereas it is expected that medi- the advancement of pharmacy and public health.
cal practitioners in general would not take to practice of pharmacy
by
I shall follow the system, which I consider best for pharmaceutical
owing drugstores, as this ultimàtely leads to coded prescriptions and

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care and counseling of patient.
monopolistic practices, detrimental to the pharmaceutical profession, and
I shall endeavour to discover and manufacture drugs of quality to
also to the interest of patients; it should be made a general rule that

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alleviate sufferings of humanity.
pharmacists, under no circumstances, take to medical practice, that is to
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diagnosing diseases and prescribing remedies therefor, even if requested by I shall hold in confidence the knowledge gained about the patients

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patrons to do so. In cases of accidents and emergencies a pharmacist may, in connection with my professional practice and never divulge
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however, render first aid to the victim. unless compelled to do so by the law.
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No phamacist should recommend particular medical practitioner, unless I shall associate with organizations having their objectives for
specifically asked to do so. betterment of Profession of Pharmacy and make contribution to
cary out the work of these organizations.
Clandestine arrangements No pharmacist should enter into any secret
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While I continue to keep this oath inviolate, may it be granted to me
arrangements or contract with a physician, to offer him any commission or
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to enjoy life and practice of pharmacy respected by all, at all times!
any advantage by recommending his dispensary or drug store. Should I trespass and violate the oath, may the reverse be my lot!
Liaison with public Being a liaison between medical profession and Several other countries have also formulated their respective "Code of
people, a pharmacist should always keep himself abreast with the modern Ethics" but all of them are essentially same, emphasizing ethical pharma-
developments in pharmacy and other allied sciences by regularly reading ceutical practices.
books, journals, magaziies and other periodicals, so that on the one hand
he may be in a position to advise the physicians on pharmaceutical matters
like those of colours, flavours, vehicles and newer forms of administration
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of medicines, and on the other, he may be able to educate the people for
maintaining healthy and sanitary conditions of living.
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Thus a pharmacist can contribute his share in the nation building
activities of the country. A pharmacist should, at all times, endeavour to
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promote knowledge and contribute his quota in the advancement of
learning.
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A pharmacist should never disclose any information, which he has
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acquired during his professional activities to any third party or person,

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unless required to do so by law. He should never betray the confidence
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his
which his patrons repose in him or which he has won by virtue of
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eminent character and conduct.
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PHARMACISTS' OATH
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A young prospective pharmacist should feel no hesitation in assuming
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the following Pharmacists' Oath:

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*I swear by the Code of Ethics of Pharmacy Council of India
relation to the community and shall act as an integral part of
health care team.
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Insta - Study_Pharmacy_29
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Registered pharmacist means a person whose name is for the time being
entered in the register of the State in which he is for the time being

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residing or carrying on his profession or business of pharmacy.
State Council means a State Council of Pharmacy constituted under Section
19 and includes a Joint State Council of Pharmacy in accordance with

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an agreement under section 20 of the Act.

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Pharmacy Act
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PHARMACY COUNCIL OF INDIA

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It is constituted by the Central Government every five years. The first
Central Council (Pharmacy Council of India or PCI) was constituted in 1949.
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of phar-
Introduction In India, Pharmacy Act governs the practice It consists of the following members:
as a member of
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macy. In modern perspective, a pharmacist is regarded
system. The primary
health care team or an essential component of health A. Elected members:
by making
obligation of pharmacy is to safeguard the public health 1. Six members including at least one teacher each in pharmaceutical
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medicaments.. Medicines are of vital importance and
available the right chemistry, pharmacy, pharmacology'. and pharmacognosy on the
storage etc. need a
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hence their handling, compounding, dispensing and teaching staff of an Indian university or an affiliated college
specialized knowledge, skill and training of the personnel
thorough and provided granting a degree or diploma in pharmacy. These members are
called pharmacists. The desired knowledge, skill and training are elected by the University Grants Commission (UGC). New Delhi.
through the pharmacy courses. 2. One member elected by the Medical Council of India from amongst
broad objective of.
The Pharmacy Act 1948 was passed with the its members.
course
regulating the practice of pharmacy in India. It provides for the 3. One member who shall be a registered pharmacist, to represent
pharmacists should go through, the nature and period
which the would-be each State elected by State Council from amongst its members.
examinations which they
of training which they should undergo, and the
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as pharmacists.
must pass in order to become eligible for registration
B. Nominated members:
State Pharmacy Councils and th Pharmacy Council of India (Central 1. Six members including at least four persons possessing degree or
Council) are responsible for the registration of pharmacists.
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diploma in pharmacy and engaged in the practice of pharmacy or
Jammu and
The Act extends to the whole:of India except the State of pharmaceutical chemistry, nominated by the Central Government.
Kashmir. 2. One representative each of University Grants Commission and All
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India Council for Technical Education (AICTE).
Definitions
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3. One registered pharmacist to represent each State nominated by
agreement means an agieement entered into under section 20 (inter-State
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the State Government/Unicn Teritory Administration.

agreement regarding constitution of State Councils).
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(courses of C. Ex-officio members:
approval means approval by the State Council under section 12
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pharmacy) or section 14 (foreign qualifica- 1. The Director General of Health Services

study and examinations in
Act.
tion) for the purpose of qualifying for registration under the
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2. The Director of Central Drugs laboratory
under
Central Council means the Pharmacy Council of India constituted 3. The Drugs Controller General of India.
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Section 3. The president and the vice-president of PCI are elected by the members
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Central Register means the register of pharmacists
maintained by the
of the Council from amongst themselves. They hold office for a maximum
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Central Council under Section 15-A. I

p.riod of five years but they are eligible for re-election.

maintained under
register means a register of pharmacists prepared and Elections are to be conducted in the prescribed manner and in case of
the Act. any dispute"the matter is referred to the Central Government.
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Insta - Study_Pharmacy_29
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18
PHARMACEUTICAL JURISPRUDENCE
Ch 3 PHARMACY ACT 19

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for a term of five Practical training shall be of not less than 500 hours spread over a
Any nominated or elected member shall hold office
his nomination or election or until his successor has period of not less than three months. Out of this 500 hours period not less
years from the date of

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is earlier. A nominated or than 250 hours must be devoted to actual dispensing of prescriptions. In
been duly nominated or elected, whichever
member can resign his»membership by writing under his hand to the course of practical training the trainee shall have exposure to:
elected:
deemed to have

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the President. A nominated or elected member shall be from () working knowledge of records required by various Acts covering the
vacated his seat if he is absent, without sufficient reason, the three profession of pharmacy, and

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PCI. If an ex-officio member is unable to
consecutive meetings of the (i) practical experience in:
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to attend the
attend any meeting he can authorize a person in writing be filled by fresh (a) principle and working of pharmaceutical apparatus in common
the PCI shall

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meeting on his behalf. A casual vacancy in
use;
nomination or election and the person so nominated or elected shall hold
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(b) reading, translation and copying of prescriptións including

the office for the residual term only.
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checking of doses;
as its Secretary
The Council shall appoint (i) a Registrar who shall act () dispensing of prescriptions illustrating the general methods of
as well; and (i) other officers and servants administering medicaments; and
and, if necessary, its Treasure
The Executive Committee of the
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for carrying out its statutory functions. (d) storage of drugs and medical preparations.
Committee), the Vice-
PCI consists of the President (Chairman of the
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by the Central Council from Pharmacy Council of India is also required to make available copies of
President and five othef members elected its minutes and that of the Executive Committee and an annual report of
amongst its members. its activities to the Central Government. It shall also maintain its accounts
and other records in the prescribed manner. It is also required to maintain
EDUCATON REGULATIONS (ER) # a register of pharmacists known as Central Register. This register contains
with the ap-
Education Regulations are made by the Central Council names of all persons for the time being entered in the registers of different
ER prescribe the minimum qualification States. Thus the Central Register is a compilation of all State Registers and
proval of the Central Government.
for registration as a pharmacist. will have information about all registered pharmacists in the whole country.
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The ER may prescribe: Approved courses of study and examinations Approval of PCI is es-
1. The nature and period of. (a) study, and (b)
practical training. sential not only for a course or an examination but also for starting any
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for students undertak- course in pharmacy. Any authority or institution in India condurtinga
2. The equipment and facilities to be provided
courses of study. course of study for pharmacists must apply to PCI for approval of the
ing approved
course and examination. The Council then deputes its ins pectors to visit
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standards to de attained.
3. The subjects of èxamination and the the institution and ascertain whether the institution has the minimum
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4. Any other condition of admission to examination. facilities for running such a course or holding examinations as per the ER.
considera The inspectors may also be required to attend any examination without
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Education Regulations can be amended only after taking into

Education Regulations interfering in its conduct, to judge its standard. The inspectors submit
tion the comments of State Governments.
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by the State
take effect in a State from the date notified their report and recommendations to the PCI and accordingly any course or
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Government. examination is approved or rejected.. Unless a person passes out from a

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undergo practical PCI approved institution and completes the prescribed practical training, he
According to ER-91, a candidate shall be eligible to
cannot be registered as a pharmacist and hence cannot practice the profes
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having appeared in Diploma- in Pharmacy Part II Examination

training after sion of pharmacy.
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in one or more of the following institutions.
Pharmacy education in India has dual control, PCI as well as AICTE and
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(1) Government hospitals/dispensaries. falls under technicat siluca.ion as per the All India Council for Technical
by the PCI.
(2) Other hospitals/dispensaries recognized Education Act. Therefore the AICTE also assesses and evaluates through its
(3) Licensed pharmacy, chemists and druggists shops. expert committees the facilities for starting a new course in pharmacy,
(4) Licensed drug manufacturing units. continuance of the existing courses, and increase in intake.
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Insta - Study_Pharmacy_29
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20 PHARMACEUTICAL JURISPRUDENCE
Ch-3 PHARMACY ACT
21

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Withdrawal of approval If an approved course of study or an ap-
proved examination no longer continues to be in conformity with the State Council Joint State Council

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Education Regulations, PCI gives notice to the concerned authority of its Elected Members:
intention to consider the withdrawal of approval. The said authority () Six registered pharmacists elected 3-5 registered pharmacists of each of the
should, within three months from the receipt of such notice, forward to

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from amongst. themselves. participating State elected from amongst
PCI. through the State Government, its representation, if any. After
themselves. However if agreed, the

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considering such representation along with the observations of the State number of members elected by each of
Government, PCI may declare that the course of study or the examination
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the participating State may not be equal

shall be deemed to be approved only when completed or passed before a but shall be from 3-5 only.

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particular date. (i One member electod from amongst One member elected by the Medical Coun-
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themselves by the members of cil of each State from amongst its

Approval of other qualifications PCI may approve any foreign quali the Medical Council of the State.
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fication for the purpose of registration as pharmacist in India. Such members.
approval is given on reciprocal basis. It means that the registration Nominated Members:
authority of the other country should also recognize the PCI approved ) Five members of whom at least 2-4 members nominated by each partici-
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Diploma or Degree of any institution in India. three shall be possessing a de- pating State of whom more than half shal
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gree or diploma in pharmacy or be possessing a degree or diploma in
Central Register of Pharmacists ii pharmaceutical chemistry or be pharmacy or pharmaceutical chemistry or
The Central Council is required to maintain a register of pharmacists
registered pharmacists, nominated be registered pharmacists. However, if
by the State Government. agreed, the number of members nominated
known as the Central Register. This register contains the names of all by each of the participating State may not
persons' for the time being entered in the registers of different States. be equal but shall be from 2-4 only.
Each State Council is required to supply five copies of its register to the Ex-officio Members:
Central Council as soon as after the 1st April every year. All additions or
amendments in the State register are to be informed by the Registrars of () Chief administrative Medical of Chief administrative Medical officer of
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each State Council to the Central Council from time to time. Thus Central ficer of the State. each of the participating States.
Register is a compilation of al, State registers. (i) Officer-in-charge of Drugs and Officer-in-charge of the Drugs Control Or-
Cosmetics Act, 1940.
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ganisation of each participating State.
Registrar of the Central Council is duty bound to keep the Central
(ii) Government Analyst under the Government Analyst of each participating
Register in the manner prescribed by the Council. He is also required to Drugs& Cosmetics Act or where State under the Drugs & Cosmetics Act or
revise the Central Register from time to time and publish the same in the
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there is more than one, such as where there is more than one in each
Gazette of India. The Central Register is deemed to be a public document the State Government may ap- State, such one as the State Government
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within the meaning of the Indian Evidence Act, 1872. point in this behalf. may appoint in this behalf.
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STATE PHARMACY CoUNCILS Inter-State agreements are agreements for the constitution of a
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Joint State Council for all the participating States or that the State Council
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State Pharmacy Councils and Joint State Pharmacy Councils are also of one State shall serve the needs of the other participating States.
constituted by the State Governments. Two or more States may also agree
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Each State Council shall have a President and a Vice-President elected
that the State Council of one State shall serve the needs of the other by the members from amongst themselves. It may also appoint a
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participating States. Two or mote States may also enter into an agreement Registrar
who may act as its Secretary and also as Treasurer. It may also appoint
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(inter-State agreement) for definite and specified periods to form Joint necessary officers and servants to carry out its functions under the
State Cpycils Any pharmacist willing to practice in a State has to get
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Pharmacy Act. The State Council is also required to constitute an Executive

himself registered in that State through the State Pharmacy Council. The Committee similar to that of the Central Council It should also submit
constitution of State Councils and Joint State Pharmacy Councils is as the necessary information and annual report to the State Government.
follows:-
an exofficio member of an organisation is only a member because of his/her
position or rank
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Insta - Study_Pharmacy_29
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22

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person whose name is entered in the register. Upon constitution of the
Inspection AState Council may appoint inspectors having prescribed
inspect any premises where drugs are compounded or State Council, the register is handed over into its custody..

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qualifications to (i)
or
dispensed; (1i) enquire whether a person who is engaged in compounding Qualifications for entry on first register A person who has attained
disperising of drugs is a registerd pharmacist; (ii) investigate any complaint the age of 18 yeárs shall, on payment of the prescribed fee, be entitled to

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regarding contravention of the Act; (iv) institute prosecution under the order have his name entered in the first register if he resides or carries on the
of the Executive Committee of the State Council; and (v) exercise such other

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business or profession of pharmacy in the State, and if he:
powers as are necessary for certain purposes of this Act.
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(a) holds a degree or diploma in pharmacy or pharmaceutical chemistry

Every inspector is deemed to be a public servant as defined under or a chemist and druggist diploma of an Indian university or a

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in the
India enal ( de. Any person willfully obstructing an inspector State Government ora prescribed qualification granted by an
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powers is punishable with imprisonment upto 6 months or

exercise of his authority outside India; or
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with fine up to 7 1000 or with both. (6) holds a degree of an Indian university other than a degree or
diploma in pharmacy or pharmaceutical chemistry, and has been
REGISTRATION OF PHARMACISTS engaged in the compounding of drugs in a hospital or dispensary
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Pharmacy Act provides for the registration of pharmacists to regulate or other place in which drugs are regularly dispensed on prescrip-
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the entry of persons in this profession. It ensures that
only those persons tions of medical practitioners, for a total period of not less than 3
having requisite qualifications, training, and experience relating to the years; or
compounding, dispensing, handling, storage etc. of the drugs are allowed ()has passed an examination recognized as adequate by the State
to enter the practice of pharmacy. Government, for compounders or dispensers; or
Names of the registered pharmacists are entered in the registers (c) has been engaged in the compounding of drugs in a hospital or
maintained by the State Councils and the Central Council. The State dispensary or other place in which drugs are regularly dispensed on
Governments are rèsponsible for the preparation of the first registers
in prescriptions of medical practitioners, for not less than 5 years
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State as soon as after the chapter relating to registration of prior to the date notified by the State Government for receipt of
each
pharmacists has taken effect in any State. Thereafter, as soon as the State applications for entry of names on the first register to the
of these
Councils are constituted, they are responsible for the maintenance
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Registration Tribunal.
registers. The register includes the following particulars: Subsequent Register After the date appointed by the State Govern-
pharmacists
1. full name and residential address of the registered ment for receiving the applications for registration by the Registration
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2. date of his first admission to the register Tribunal and, before the Education Regulations have taken.effect in the
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State, person who has attained the age of 18 years and residing or
3. nis qualifications for registration;
carrying on the business or profession of pharmacy in the State. is entitled
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4. his professional address, and in case of

employed persons, the
to have his name entered in the register on payment of the prescribed fees
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name of the employer; and
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5. such other particulars as may be prescribed. (a) satisfies the conditions prescribed and approved by the Central
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First Register For the preparation of the first register, the State Council, or where no qualification has been prescribed, the condi-
in the tions entitling a person to have his name entered on the first
Government constitutes a Registration Iribunal by notification
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Official Gazette. The Tribunal consists of three persons and a registrar- register and has passed a matriculation or an equivalent examina-
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a date
cum-secretary is also appointed. The State Government appoints tion; or
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registration, accompanied by.the prescribed

before which applications for (b) is a registere. pha macist in another State; or
Applications
fee, should be submitted. to the Registration Tribunal. (c) possesses a qualification granted by an authority outside India,
received upto the appointed date are examined by the Tribunal and if the
and' approved by the Central Council and has passed a matriculation
applicant is found to be qualified for registration, his name is entered on or equivalent examination.
to every
the register. The Registrar issues a certificate of registration
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24
Pharmacy PHARMACEUTICAL JURISPRUOENCE Ch-3 PHARMACY ACT
25

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After the Education Regulations have become effective in the State, a 1959, and who satisfy the conditions for registration in the first
person shall be entitled for registration if he has (a) attained the age of 18 register.

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years; (6) resides or carries on the business or profession of pharmacy in
Registration under these provisions tould' be obtained by making an
the State; and () passed an approved examination or holds a qualification
application accompanied by prescribed fee to the State Council These

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granted by an authority outside India and approved by the Central Council;
provisions were to remain in operation for a period of 2 years from the
or (d) is a registered pharmacist in another State.

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commencement of the Pharmacy (Amendment) Act, 1959. The State
Special provisions or registration of certain persons Pharmacy
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Governments were, however, empowered to extend the period of operation

(Amendment) Act of 1959 made special provisions for registration of the of items (a), (6) and (c) further upto maximum period of 2 years.

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following persons:
Registration of displaced persons, repatriates and other
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(a) displaced persons who had been engaged in the business or persons Pharmacy (Amendment) Act, 1976 provided. for registration of
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profession of pharmacy as their principal means of livelihood following categories of persons for a period of 2 years from the commence-
before the 4th March 1948 and who satisfied the conditions for ment of this Amendment Act:
registration in the first register of the States;
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(a) persons who possess degree or diptoma in pharmacy or pharmaceu-
(b) citizens of India who had been engaged in the business. or tical chemistry or chemists and druggists' diploma or have passed
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profession of pharmacy abroad and satisfied the conditions for an examination recognized adequate for compounders and dispens-
registration in the first registers of the States; ers by the State Governments and who were eligible for registration
(c) who resided in an area which subsequently became a temitory of between the closing of the first register and the date when the
India and who satisfied the conditions for registration in the first Education Regulations came into effect;
register of the States; (6) persons approved as qualified persons beforé the 31st December,
(c) who carry on the business or profession of pharmacy in' a State and 1969 for compounding and dispensing of medicines under the
who were qualified for registration in the first register had they Drugs and Cosmetics Act, 1940 and the Rules;
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applied for registration before the appointed date but did not do (c) displaced persons from Bangladesh who left that country after 14th
so for some or the other reason; or April, 1957 but before 25th March 1971 and "repatriates" from
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(e) have been engaged in the compounding of drugs in a hospital or Burma, Sri Lanka, Uganda or any other country who left or were
dispensary or other place in which drugs are regularly dispensed on displaced from such country between 14th April 1957 and 25th
prescriptions of medical practitioners for a total period of not less March 1971 and were carrying business or profession of pharmacy
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than 5 years prior to the date appointed; as the. principal means of their livelihood for a total period of 5
years prior to the date of application.
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who were qualified to be registered in a State as it existed
immediately before: 1st November 1956, but, who due to the
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Registration after formation of the state pharmacy councils After

transfer of area in which they resided or carried on their business the appointed date, applications for registration should be addressed to
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or profession of pharmacy subsequently to another State, are not the registrar of the State Council and accompanied by the prescribed fee.
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qualified for registration in the latter only because they have not If upon such application the registrar is of the opinion that the applicant
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passed matriculation or equivalent examination or do not possess is qualified for registration under the Act, he shall enter the name of the
qualification obtained from outside India and recognized by the applicant in the register. Upon entry of a name in the register, the
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Central Council; registrar shall issue a certificate of registration in the prescribed form. No
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(g) who were registered pharmacist in a State as it existed immediately person whose name has been removed from the register of any State shall
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before 1sti t ven.ber, 1956; and later on became residents of be entitled to have his name entered in the register except with the
another State which has already closed its first registe; approval of the State Council. Any person whose application for registra-
(h) who reside or carrý on their business or profession of pharmacy in tion has been rejected by the registrar, may within 90 days from the date
an area in which the chapter relating to the registration, takes of such rejection, appeal to the State Council whose decision shall be final.
effect after the commencement of the Pharmacy (Amendment) Act,
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26
is that he is a registered pharmacist shall be punished on first conviction with
Registration isvalid upto 31st December of the year of registration. It fine extending upto 500 and on any subsequent conviction with imprison

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renewed on payment of annual fees to the State Council. ment upto 6 months or with fine not exceeding 1000 or with both.
Renewal fees become due to be paid before the first day of April the
by However it shall be a defence to show that the name of the accused is
fee is not paid the due

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year to which it relates. Where the renewal
entered in the register of another State and that at the time of the alleged
date, the registrar shall remove the name of the defaulter from the register, offence an application for registration had been made in the State in

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on
provided that a name thus removed may be restored to the register question.
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futfilling prescribed conditions. On payment of the renewal fee, the

of The use of the description "Pharmacist", "Chemist", "Druggist", "Phar-
registrar shall issue a receipt therefor, which shall be proof of renewal

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pharmacist is entitled to have any further maceutist", "Dispenser, "Dispensing chemist", or any combination of such
registration. A registered
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words or of any such word with any other words shall be deemed to
professional qualification (obtained after his first registration) entered
in
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on payment of the prescribed fee. suggest that the person using such description is a registered pharmacist.
the register It is immaterial whether or not any person is deceived by such pretence or
Removal of names from register The Executive Committee of a State use as aforesaid. The onus (burden) of proving that the name of a person
be
Council may order that the name of a registered pharmacist shall
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is for the time being entered in the register of a State lies on such person
where is satisfied, after giving him a
register it
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removed from the only. Cognizance of such an offence shall be taken only upon complaint
and after necessary inquiry; on the
reasonable opportunity of being heard made by the order of the State Government or any officer authorised in
following grounds: this behalf by the State Government or by the order of the Executive
or on account Committee of the State Council
() If his name has been entered in the register by error
of misrepresentation or suppression of a material fact; or
Dispensing by unregistered persons On or after the date notified by
convicted of any offence or has been found guilty the State Government in this behalf, no person other than a registered
(i) If he has been which in the
of any infamous conduct in any professional respect pharmacist can compound, prepare, mix, or dispense any medicine on the
opinion of the Executive Committee, renders him unfit to be kept prescription of a medical practitioner. This however does not apply to
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in the register; or dispensing medicines by a medical practitioner to his patients, or with
(ii) If a person in his employment in connection with any business of the sanction of the State Government, for the patients of another medical
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pharmacy has been convicted of any such offence or has been practitioner.
found guilty of any such infamous conduct as would, if such Dispensing by unregistered persons is punishable with imprisonment
his
person were a registered pharmacist, render him liable to have 1,000 or with both. Cognizance of
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upto 6 months, or with fine upto
name removed from the register. such an offence shall not be taken except upon complaint made by order of
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A person whose name has been removed from the register shal the State Government or by any officer appointed in this behalf by the
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removed shall be
surrender his certificate to the registrar and the name so State Government, or by order of the Executive Committee of the State
Council. When no such date is appointed by the Government of a State,
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published in the Official Gazette.
these provisions take effect in that State on the expiry of 8 years from the
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Restoration to register Name of a person removed from the register commencement of the Pharmacy (Amendment) Act, 1976 i.e. 1st Septem-
prescribed fee.
can be restored by the State Council on payment of
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ber, 1984.
A duplicate certificate can be issued by the Registrar
on payment of
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or Failing to surrender certificate of registration If any person whose

prescribed fee if he is satisfied that an original certificate has been lost
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name has been removed from the register fails without sufficient cause to
damaged.
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surrender his certificate of registration, he shall be punishable with fine

MISCELLANECUS extending to 50. Cognizance of this offence shall not be taken except
person upon complaint made by an order of the Executive Committee of the State
Penalty for falsely claiming to be registered pharmacist Any Council
who falsely claims to be a registered pharmacist and uses in connection
with his name or title any words or letters reasonably calculated to
suggest ww.
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29

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beings or animals, as may be specified from time to time by the Central
Government by notification in the Official Gazette; () all substances

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intended for use as components of a drug including empty gelatin

4 capsules; and (d) such devices intended for internal or external use in
the diagnosis, treatment, mitigation or prevention of disease or disor

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der in human beings or animals as specified by the Central Government.

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Ayurvedic, Siddha or Unani drug includes all medicines intended for
Drugs and Cosmetics Act and Rules
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internal or external use for or in the diagnosis treatment, mitigation or

prevention of disease or disorder in human beings or animals and

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manufactured exclusively in accordance with the formulae described in
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Drugs are vital to the health of an individual but cosmetics do not play the authoritative books of Ayurvedic, Siddha and Unani tibb systems of
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any role in our health. Drugs have been classified as essential commodity medicine specified in the First Schedule to the Act.
under Essential Commodities Act. The Drugs and Cosmetics Act, 1940 and Central licence approving authroity means the Drugs Controller, India
Rules, 1945 have been passed with the objective of regulating the import, appointed by the Central Government.
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manufacture, distribution and sale of drugs and cosmetics. Act regulates
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Cosmetic means any article intended to be rubbed, poured sprinkled or
the manufacture and sale of drugs and cosmetics through licensing so that sprayed on, or introduced. into, or otherwise applied to the human body
these are manufactured, distributed and sold only by qualified persons or any part thereof for cleansing, beautifying, promoting attractiveness,
Act covers the drugs under allopathic, ayurvedic, homoeopathic and Unani or altering the appearance, and includes any article intended for use as
Tibb systems as well as drugs for veterinary use. The main object of the a component of cosmetic.
Act is to prevent substandards in drugs. It is a life saving statute and
extends to whole of India. Patent or proprietary medicine means-
The Drugs and Cosmetics (Amendment) Act, 2008 was brought into
(a) In relation to Ayurvedic, Sidha or Unani Tibb systems of medicine
all formulations containing only such ingredients mentioned in the formu-
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force with effect from 10 August, 2009. Main features of the Amendment
lae described in the authoritative books of Ayurvedic, Sidha, Unani or Tibb
Act include (i) insertion of new Section 17-E i.e. adulterated cosmetics,
systems of medicine specified in the First Schedule, but does not include a
(i) insertion of Sections 36-AB (Special courts for tria of offences relating
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medicine which is administered by parenteral route and also a formulation
to adulterated drugs or spurious drugs, and (ii) insertion of Section 36-AC
included in the authoritative books as specified in the First Schedule;
(offences relating to adulterated drugs or spurious drugs to be cognizable
(b) In relation to any other systems of medicine, a drug which is a
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and non-bailable in certain cases.
remedy or prescription presented in a form ready for internal or external
Drugs and Cosmetics (Third Amendment) Rules, 2008 came into force
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administration of human beings or animals and which is not included in
with effect from 1 November, 2010 and introduced the requirements of
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the edition of the Indian Pharmacopeia for the time being or any other
"Good Laboratory Practices" as laid down in Schedule L-I. Pharmacopaeia authorised in this behalf by the Central Government after
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Definitionsi consultation with the DTAB.
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Drugs includes (o) all medicines for internal or external use of human Misbranded drugs A drug is deemed to be misbranded:
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beings or animals and all substances intended to be used for or in the 1. if it is so coloured, coated, powdered or polished that damage is
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diagnosis, treatment, mitigation or prevention of any disease or disor- concealed or if it is made to appear of better or greater therapeutic
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der in human beings or animals, including preparations applied on value than it really is; or
human body for the pyrrse repelling insects like mosquitoes;
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(6) such substances (other than iood) intended to affect the structure
2. if it is not labelled in the prescribed manner; or
3. if its label or container or anything accompanying the drug bears
or any function of the, human body or intended to be used for the
any statement, design or device which makes any
destruction of the vermin or insects which cause disease in human fale claim for
the drug or which is false or misleading in any particular.

28
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30
Ayurvedic Siddha or Unani drug includes all medicines intended for
Adulterated drugs A drug is deemed to be adulterated: internal or external use for or in the diagnosis treatment, mitigation or

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1. if it consists, in whole orpart, of any filthy, putrid or decomposed prevention of disease or disorder in -human beings or animals and
substance; or manufactured exclusively in accordance with the formulae described in

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2. if it has been prepared, packed or stored under insanitary condi- the authoritative books of Ayurvedic, Siddha and Unani Tibb systems
tions whereby it may have been rendered injurious to health; or of medicine specified in the First Schedule of the Act.

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3. if its container is composed, in whole or in part, of
any poisonous Homoeopathic medicines include any drug which is recorded in homoeo
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or deleterious substance which may render the contents injurious pathic provings or therapeutic efficacy of which has been established

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to health; or through long clinical experience as recorded in authoritative Homoeo
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4. if it bears or contains for purposes of colouring only, a colour pathic literature of India and abroad and which is prepared according
to the techniques of homoeopathic pharmacy and covers combination of
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other than one which is.prescribed; or
ingredients of such homoeopathic medicines but does not include a
5. if it contains any harmful or toxic substance which may render it medicine which is admínistered by parenteral route. Registered Ho-
injurious to health; or
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moeopathic Medical Practitioner means a person who is registered in
as to reduce its
6. if any substance has been mixed therewith so the Central Register or a State Register of Homoeopathy.
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quality or strength. Cosmetic means any article intended to be rubbed, poured, sprinkled or
Misbranded drugs A drug is deemed to be misbranded: sprayed on, or introduced into, or otherwise applied to the human body
1. if it is so coloured, coated, powdered or polished that damage
is or any part thereof for cleansing, beautifying, promoting attractiveness,
concealed or if it is made to appear of better or greater therapeutic or altering the appearance, and includes any article intended for use as
value than it really is; or a component of cosmetic.
2. if it is not labeled in the prescribed manner; or Adulterated cosmetics A cosmetic shall be deemed to be adulterated
drug bears
3. if its label or container or anything accompanying the 1. if it consists, in whole or in part, of any filthy, putrid or
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any statement, design or device which makes any false claim for decomposed substance; or
the drug or which is. false or misleading in any particular. if it has been prepared, packed or stored under insanitary condi-
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Spurious drugs A drug is deemed to be spurious:- tions whereby it may have been contaminated with filth or whereby
it may have been rendered injurious to health; or
1. if it is imported (manufactured-in relation to manufacture, sale and
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distribution of drugs) under a name which belongs to another 3. if its container is composed, in whole or in part, of any poisonous
or deleterious substance which may render the contents injurious
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drug; or
to health; or
imitation of or is a substitute for another drug or
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if it is an
resembles another drug in a manner likely to deceive or bears upon 4. if it bears or contains, for purposes of colouring only, a colour
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it or upon its label or container the name of another drug unless it other than one which is prescribed; or
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is plainly and conspicuously marked so as to reveal its true 5. if it contains any harmful or toxic substance which may render it
character and its lack of identity with such other drugs; or
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injurious to health; or
if the label or container bears the name of an individual or 6. if any substance has been mixed therewith so as to reduce its
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which quality or strength.

Company purporting to be the mânufacture of the drug,
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individual or company is fictitious or does not exist; or Misbranded cosmetics A cosmetic is deemed to be misbranded:
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or
4. if it has been substituted wholly or in part by another drug 1. if it contains a colour which is not prescribed; or
substance; or 2. if it is not labeled in the prescribed manner; or
5. if it purports to be the product of a 'manufacturer of whom it is 3. if the label or container or anything accompanying the cosmetic
not truly a product. bears any statement which is false or misleading in any particular.
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32 Pharmacy PHARMACEUTICAL JURISPRUDENCE
Ch-4 DRUGS AND COSMETICS ACT AND RULES
33
Schedules to the Rules

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Spurious cosmetics A cosmetic is deemed to be spurious: A- Proforma for application for the licenses, issue and renewal of
cosmetic;
1. if it is imported under a name which belongs to another

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licenses, for sending memoranda under the Act.
or B Rates of fee for test or analysis by the Central Drugs Laboratory or
2. if it is an imitation of, or is a substitute for, another
cosmetic or
the Government Analyst.

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resembles another cosmetic in a manner likely to deceive or bears
of another C- List of biological and special products whose import, sale, distribu-
upon it or upon its label or container the name

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tion and manufacture are governed by special provisions.
cosmetic, unless it is plainly and conspicuously marked so as to
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reveal its true character and its lack of identity with such other C1-List of other special products whose import, sale, distribution and

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Cosmetic; or manufacture are governed by special provisions.
an individual or a
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3. if the label or container bears the name of D- List of drugs exempted from the provisions of import of drugs.
cosmetic, which
Company purporting to be the manufacturer of the
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D-1 Information and undertaking to be submitted by the manufacturer
individual or company is fictitious or does not exist; or with the application form for a registration certificate.
of whom it is
4. if it purports to be the product of a manufacturer D-2 Information to be submitted by the manufacturer or his authorised
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not truly a product. agent with the application fom for registration of a bulk drug/
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Patent or proprietary medicine means- formulation/special product for its import into India.
systems of medicine
(a) In relation to Ayurvedic, Sidha or Unani Tibb Annexure-A Specific information for the blood products.
all formulations containing only such ingredients mentioned in the Annexure-B Specific information for the diagnostic kits.
formulae described in the authoritative books of Ayurvedic,
Sidha,
Unani or Tibb systems of medicine specified in the First Schedule, Annexure-A Specific information for vaccines.
by parenteral
but does not include a medicine which is administered D-3 Information and undertaking to be submitted by the manufacturer
route and also a formulation included in the authoritative books as or his authorised importer/distributor/agent with the application
specified in the First Schedule; form for a registration certificate.
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(b) In relation to any other systems of medicine, a drug which is
a
E1 List of poisonous substances under the Ayurvedic (including Sidha))
remedy or prescription presented in a form ready for internal or and Unani systems of medicine.
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external administration of human beings or animals and which is F- Part XITB Requirement for the functioning and operation of the
not included in the edition of the Indian Pharmacopeia for the blood bank and/or for preparation of blood components.
time being or any other Pharmacopaeia authorised in this behalf by
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DTAB. Part XTI C I- Requirement for manufacture of blood products.
the Central Government after consultation with the
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Controller, India Part XTI C Requirement for manufacture of blood products from
Central licence approving.authority means the Drugs II-
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bulk finished products.

appointed by the Central Government.
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Part XIII - General
There are 2 schedules to the Drugs and Cosmetics Act and 24 schedules
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to the Drugs and Cosmetics Rules, each dealing with a particular subject, F-1- Part I
A- Provisions applicable to the production of baçterial
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as followS: vaccines.
Part I B Provisions applicable to the production of viral vacines.
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Schedules to the Act i

Part TI Provisions applicable to the production of all sera from
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First Schedule-Names of books under Ayurvedic and Sidha systems. living animals.
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Second Schedule-Standard to be complied with by imported drugs and 1

Pait III- Provisions applicable to the manufacture and standardiza-"
by drugs manufactured for sale, sold, stocked or exhibited
for sale or
tion of diagnostic agents (bacterial origin).
distributed.
Part IV General
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Ch-4 DRUGS AND COSMETICS ACT AND RULES 35

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F2-Standards for surgical dressings. Part II-A- List of machinery, equipment and minimum manufacturing
F3- Standards for sterilized umbilical tapes. premises for manufacture of various categories of Ayurvedic,

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FF Standards for ophthalmic preparations. Siddha system of medicines.
G List of substances thatare required to be used only under medical Part I1-B- List of machinery, equipment and minimum manufacturing

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supervision and which are to be labeled accordingly. premises for manufacture of various categories of Unani
system of mediçines.

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H List of prescription drugs.
Part I1-C- List of equipment recomimended for in-house quality
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H1 List of certain antibiotics, anti-TB drugs and habit forming drugs

control section.
not to be sold by retail without the prescription of a Registered

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Medical Practitioner. Part I1-D- Supplementary guidelines for manufacture of Rasaushadhies
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or Rasamarunthukal and Kushtajat of Ayurvedic, Siddha and

Diseases or ailments which a drug may not purport to prevent or
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J- Unani system of medicines.
cure.
manufacture T-A Form for record of utilization of raw material by Ayurvedic/Siddha/
K- Drugs exempted from certain provisions relating to the Unani manufacturing units.
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of drugs.
Particulars to be shown in manufacturing, raw material and analyti-
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and U-
L-1- Good Laboratory Practices (GLP) and requirements of premises cal records of drugs.
equipments.
U1- Particulars to be shown in manufacturing, raw material and analyti-
M- Good Manufacturing Practices (GMP) requirements of factory premises,
cal records of cosmetics.
plants and equipment.
V-Standards for patent or proprietary medicines.
M1- Requirements of factory premises etc. for manufacture of homeo-
pathic preparations. W-List of drugs which are to be marketed under generic names only.
M2 Requirements of factory premises for the manufacture of cosmetics. X- List of drugs whose import, manufacture and sale, labeling and
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packaging are governed by speciai provisions.
M3 Requirements of factory premises for manufacture of medical de-
Y Requirements and guidelines for permission to import and/or
vices.
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a pharmacy. manufacture of new drugs for sale or to undertake clinical trials.
oN-List of minimum equipment for efficient running of
0 Standards for disinfectant fluids. SALE OF DRUGS
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Life periods of drugs.
P- The drugs reach the consumers from the manufacturers by retail through
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P1 Pack sizes of drugs. shopkeepers. Manufacturers generally sell their goods to the wholesalers
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Q Part I - List of dyes, colours and pigments permitted in cosmetics and (stockists) who, in turn, sell the same to the retailers (shopkeepers).
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soaps. Under the Drugs (Prices Control) Order, 1987 wholesaler' means a dealer
or his agent, or a stockist appointed by a manufacturer or an importer for
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Part II- List of colours permitted in soaps.

the sale of his drugs to a retailer; and a retailer means a dealer carrying on
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R Standards for condoms made of rubber latex intended for single
use
the retail business of sale of drugs to customers.
and other mechanical contraceptives.
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Sale licences are issued for the following categories of drugs:

R1 Standards for medical devices.
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1. Drugs other than' those specified in Schedule C, C1 and X;
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S Standards for cosmetics.

2. Drugs specified in Schedule C and C1 but excluding X; and
T- GMP for Ayurvedic, Siddha a.d Ui,ani medicines. 3. Drugs specified in Schedule X.
Part I- Good Manufacturing Practices. Rules also provide for the wholesale and retail sale of these drugs.
Wholesale and distribution of drugs specified in Schedule C and C1, and
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36
PHARMACEUTICAL JURISPRUDENCE
Ch-4 DRUGS AND COSMETICS ACT AND RULES 37

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permitted by
other than those specified in Schedule C, C1 and are also
X
In respect of an application for grant of a licence for wholesale of drugs
is taken. All the three categoies of
motor vehicles provided a licence 'other than those specified in Schedule C, C1 but excluding X, th licensing

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sale of drugs
drugs can also be sold on retail. Restricted licences for the X' authority shall satisfy himself that the premises in respect of which a
C C1 excluding are also licence is to be granted are:
other than those specified in 'Schedule and place) vendors and other
issued to the itinerant (travelling from place to

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person. 1. of an area of not less than 10 sq. metres; and
dealers who do not engage the services of a 'qualified 2. in the charge of a competent person, who is a registered pharma-

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Latest amendment: Sale of Drugs Under Schedule H1 cist or who has passed the matriculation examination or its
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Schedule H equivalent with 4 years experience in dispensing of drugs.

Under the Drugs & Cosmetics Rules, drugs specified under

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are required to be sold by retail on the prescription of a
and Schedule X
Wholesal of Drugs i
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& Schedule X contains 510 & 15 drugs,

RMP only. At present Schedule H
introduced on 30-08- (1), Drugs other than those specified in schedule C, C1 and X
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respectively. Recently, a new Schedule H1 has been Licence issued in Form 20B is subject to the following conditions in
generation antibiotics, certain
2013, which contains certain 3rd and 4th addition to the general conditions discussed earlier:
to be sold
habit forming drugs and anti-TB drugs. These drugs are required
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in the country with the following conditions: 1. Licence should be displayed in a prominent place open to the
public.
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time of
(1). The supply shall be recorded in a separate register at the
prescriber, the name of the 2. Licensee should comply with provisions of the Drugs and Cosmetics
the supply giving the name and addrešs of the
such records Act, 1940 and the Rules in force.
patient, the name of the drug and the quantity supplied and
shall be maintained for years
3 and be open for inspection. 3. Drugs should be purchased only from a duly licensed dealer or
Rx which shall be in red manufacturer.
(2) Drugs shall be labelled with the symbol
conspicuously displayed on the left top corner of the label, and shall 4. Sale can be made to a person holding requisite licence to sell or
and
following words in a b0x with a red border distribute the drugs. However this shall not apply to the sale of
also be labelled wiith the
any drugs to -
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Schedule H1 Drug-Warning: (a) an officer or authority purchasing on behalf of Government; or
-It is dangerous to take this preparation except (6) a hospital, medical, educational or research institution or a
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in accordance with the medical advice. RMP for the purpose of supply to his patients; or
(c) a manufacturer of beverages, confectional biscuits and other
-Not to be sold by retail without the prescrip- non-medical products, where such drugs are required for process-
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tion of a Registered Medical Practitioner." ing their products.
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An original licence or a renewed licence to sell drugs remains
valid upto (2) Other than schedule C and C1 drugs from a motor vehicle:
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in which it is granted or
31st December of the year following the year Licence issued in Form 20BB is subject to the following conditions in
renewed. Licence shall be deemed to have expired if
application for its addition to the general conditions discussed earlier:
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within six months after the expiry. In the event of
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renewal is not made 1. Licence should be displayed in a prominent part of the vehicle.
should inform
any change in constitution of a licensed firm, the licensee
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2 to 4. As for drugs other than those specified in Schedule C, C1 and X.
licensing authority. Licences of such firms remain valid for a maximum
the
3 months from the date of change unless in the meantime
a fresh 5. Licensee should inform the licensing authority any change in the
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period of
ownership of the vehicle specified in the icence within 7 days of
licence has been obtained.
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respect of such change.
Licensing authority must be satisfied that the premises in
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which licence is to be granted are adequately equipped with (1) proper (3) Schedute X drugs: Licence issued in Form 206 is subject to
accommodation for preserving the properties for drugs to which licence following conditions in addition to the general conditions discussed ear-
applies, and (ii) it is in charge of person competent to
a supervise and lier:
control the sale, distribution and preservation of drugs.
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Insta - Study_Pharmacy_29
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Ch-4 DRUGS AND COSMETICS ACT AND RULES
E24792 39

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1. Licence should be displayed in a prominent part of the
premises
3. For sale of additional categories ningluded in the
open to the public;

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ticence, the licensee should take petimission Isom the licensing
2. Licensee should comply with the provisions of the
Drugs and authority.
Cosmetics Act, 1940 and the Rules thereunder; 4. Drugs shøuld be purchased from a duly licenced manufacturer.

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3. Drugs should be purchased from a duly licenced dealer or
manufac-
5. Wholesale for resale can be made to a person holding requisite

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turer; licence to sell or distribute drugs. Provided that this does not
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of the
4. The licensee should forward to the licensing authority copies apply to the sale of any drug to:-
invoices of sale made to the retail dealers; and (a) an officer or authority purchasing on behalf of Government; or

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to a person holding requisite licence to
:
or (6) a hospital, medical, educational or research institution, or a
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5. Sale can be made

distribute drugs specified in Schedule X. This however does not
RMP for the purpose of his patients; or
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(c) a manufacturer of hydrogenated vegetable oils, beverages,
apply to the sale of any drug to
(a) an officer or authority purchasing on behalf of government, confectionary and other non-medicinal products.
or
educational or research institution, nurs-
6. Licensee should inform licensing authority of any change in the
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(6) a hospital, medical,
or
ing home, RMP for the purpose of supply to its/his patients ownershipP of the vehicle specified in' the licence within 7 days of
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manufacturers holding a licence to manufacture drugs contain such change.
ing the drugs specified in Schedule
X.
Retail Sale
(4) Drugs specified in schedule C & C1 but not included in schedule For retail sale two types of licences are issued,
Fornm 21B is subject to the following conditions ) General, and
X: Licence issued in the
) Restricted. General licences are granted to persons who have premises
in addition to the general conditions discussed earlier: for the business and who engage the services of a Qualified, Person to
1. Licence should be displayed in a prominent
part of the premises supervise the sale of drugs and do the compounding and dispensing.
open to the public. Licences for retaii sale of drugs 'other than those specified in Sch. C, C1
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for stocking or sale
2. Licensee should observe precautions prescribed and X' are issued in Form 20, for drugs specified in "Sch. C, C1 excluding
of drugs. those specified in Sch. X in Form 21 and for Sch. X drugs in Form 20F.
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permission should be
3. For sale of each additjonal category of drugs, Conditions:
obtained from the licensing authority.
purpose of resale to 1. Licence should be displayed in a prominent place in a part of the
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4. No sale of any drug should be made for the premises open to public.
drugs.
person not holding requisite licence to sell or distribute thetoo
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Provided that this shall not apply to the sale of any drug 2. Licensee should comply with provisions of Drugs and Cosmetics Act
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government; or and Rules in force.

(a) an officer or authority purchasing on behalf of
or a
(6) a hospital, medical, educational or research institution,
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3. Any change in the qualified staff in charge should be reported by
purpose of supply to his patients; or licensee to licensing authority within 1 month.
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RMP for the

(c) a manufacturer of hydrogenated vegetable oils, beverages, 4. Drugs should be purchased only from a duly licensed dealer or
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Confectionery and other non-medicinal products, where such manufacturer.
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drugs are required for processing their products. Any change in constitution of licensed firm should be informed to
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: Licence
(5) Drugs specified in schedule C & C1 from motor vehicle licensing authority within 3 months and in the meantime a fresh
conditions in addition to
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issued in the Form 21BB is subject to following licence should be .obtained in the name of the firm with changed
the general conditions discussed earliei:-k constitution.
on the vehicle.
1. Licence should be displayed in a prominent place 6. Precautions prescribed by licensing authority for storage of Sch.
2. Precautions prescribed by licensing authority for the storage of C, and C1 drugs; should be observed.
drugs should be observed.
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Insta - Study_Pharmacy_29
Telegram - Study
40
Pharmacy PHARMACELUTICAL JURISPRUDENCE Ch-4 DRUGS AND COSMETICS ACT AND RULES 41

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and C1 Before granting restricted licence, licensing authority may take into
7. For sale of additional categories of drugs listed in 'Sch. C

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excluding X, the licensee must take prior permission of licensing consideration the number of licences granted in a locality during last 3
authority. years and occupation, trade or business of the applicant.
Restricted Licences Licences for restricted sale of drugs 'other than Dispensing ánd compounding of drugs For the purposes of this Act

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those specified in Sch. C, C1 and X* and those specified in Sch. C, and
C1 and the Rules, Pharmacy means and includes every store or shop or other

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but not in Sch. X are issued in the Form 20A and 21A, respectively. place (i) where drugs are dispensed; or () where drugs are prepared; or
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Restricted licences can be issued to: () where prescriptions are compounded; or (iv) which by sign, symbol or
indication gives impression that operations mentioned in (), (i) and

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1. dealers or persons in respect of drugs whose sale does not require
(in are carried in the premises; or () which has upon,it or displayed
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supervision of a registered pharmacist; within it or affixed to or used in connection with it a sign bearing the
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2. itinerant vendors in exceptional cases for bonafide travelling agents word(s) "Pharmacy', 'Pharmacist, 'Dispensing Chemist, or Pharmaceutical
of firms dealing in drugs; or Chemist, or (vi) which is advertised in these terms.
3. to a vendor who purchases drugs from a licensed dealer for The premises licensed for the retail sale of drugs may be described as:
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distribution in sparsely populated areas where other channels of () Drug Store where the licensees do not engage the services of a
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distribution of drugs are not available. qualified person' or 'registered pharmacist': or
Restricted licences may also be issued to a travelling agent of a firm for () Chemists and Druggists where licensees èmploy the services of a
the special purpose of distribution to the medical practitioners or dealers, registered pharmacist but do not maintain a 'Pharmacy' for com-
for supply of 'biological and other special products specified in Sch. C. pounding against prescriptions; or
Traveling agents of licensed manufacturers, agents of such manufactur (i) Pharmacy, Pharmacist, Dispensing Chemist, or Pharmaceutical
ers and importers of drugs need not take licences for fiee distribution of Chemist, where the licensees employ the services of a 'qualified
samples of medicines to any member of medical profession, hospitals, person' and maintain a 'Pharmacy for compounding against pre-
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dispensaries and medical or research institutions. scriptions.
Conditions for Restricted Licence While granting licence for a pharmacy, the licensing authority considers
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1. Licensee must have adequate premises equipped with facilities for (i) average number of licences granted during the period of 3 years
proper storage of drugs to which licence applies provided that this immediately preceding; and (i) the occupation, trade or business ordinarily
caried out by such applicant during the preceding 3 years.
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condition does not apply to vendors.
2. Licence should be displayed in a prominent place in a part of the
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premises open to public or should be kept on the person of vendor PHARMACY
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who shall produce the same on demand by an Inspector or other This part is most vital to the Diploma pharmacists who may work in
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officer authonzed by State Govemment in this behalf. hospitals, dispensaries or chemist & druggist shops. The minimum equip-
3. Licensee should comply with provisions of Drugs and Cosmetics Act
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ment for the efficient running of a Pharmacy is laid down in Schedule N of

the Drugs and Cosmetics Rules, 1945.
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and Rules in force.
4. Drugs should be purchased only from a duly licensed dealer or Premises Entrance of a Pharmacy should bear an inscription "Phar
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manufacturer. macy. The premises of Pharmacy should be separated from rooms for
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5. Licensee can deal only in such drugs *as can be sold without the private use. Premises should be well built, dry., well-lit and ventilated and,
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supervision of a registered pharmacist. of sufficient dirpe; sion; so that all goods especially medicaments and
6. If licensee is a vendor having no fixed place of business, he should
poisons can be kept in á clearly visible and appropriate manner. The area
buy drugs from dealers specified in his licence. of dispensing department should be not less than 6 sq. metres for one
pharmacist with additional 2 sq. metres for each additional pharmacist.
7. Drugs should be sold in their original containers. The height of the premises should be at least 2.5 metres.
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Insta - Study_Pharmacy_29
Telegram - Study Pharmacy Ch-4 DRUGS AND COSMETICS ACT AND RULES 43

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PHARMACEUTICAL JURISPRUDENCE
42
Glass stirring rods.
Walls
The floor of the Pharmacy should be smooth and washable. Thermometer (0° to 200°C).

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should be plastered or tiled or oil -painted. Ample quantity of good quality Tripod stand.
water should also be available. nispensing department should be separated Watch glasses.

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by a barrier to prevent the admission of the public. Water bath.
a room Water distillation still (if eye drops and lotions prepared).
Furniture Drugs, chemicals and medicaments shall be kept in

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special containers as will Weights, Metric (1 mg to 100 g).
appropriate to their properties and in such
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Wire gauze.
prevent any deterioration of the contents. Drawers, glasses and other

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containers used for keeping medicaments shall be of suitable size and Pill finisher, boxwood; *Pill machine;
Pill boxes;
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capable of being closed tightly to prevent entry of dust. Every container

with names of Suppository mould.
shall bear a label of appropriate size, easily readable
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the Pharmacopoæias. Only if pils and suppositories are to be dispensed.
medicaments as given in
A Pharmacy shall be provided with a dispensing bench, the top of Books
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which shall be covered with washable and impervious material like stainless Indian Pharmacopoeia (curent edition).
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steel, laminated or plastic etc. National Formulary of India (current edition).
key for the The Drugs and Cosmetics Act, 1940.
A Pharmacy shall be provided with a cupboard with lock and Drügs and Cosmetics Rules, 1945.
POISON in red The
storage of poisons and shall be clearly marked with the word The Pharmacy Act, 1948.
letters on a white background. The Narcotic Drugs and Psychotropic Substances Act, 1985.
Apparatus A Pharmacy shall be provided with the following minimum General A Pharmacy shall be conducted under the continuous personal
apparatus and books necessary for making of official preparations and supervision of a Registered Pharmacist whose name shal be displayed
prescriptions: conspicuously in the premises. The pharmacist shall always put on clean
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Balance (dispensing, sensitivity 30 mg). white over . The remises and fittings of the Pharmacy shall be properly
Balance (counter, capacity 3 kg, sensitivity 1 g). kept and everything shall be in good order and clean. Al records and
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Beakers (lipped, assorted sizes). registers shall be maintained as required by laws in force. Any container
Bottles (prescription, ungraduátèd, assorted sizes). taken from the poison cupboard shall be replaced therein immediately after
Corks (assorted sizes, and tapers). use and the cupboard locked. The keys of the poison cupboard shall be
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Cork extractor. kept in the personal custody of the responsible person. Medicaments when
Evaporating dishes (porcelain).
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supplied shall have the labels conforming to the provisions of current laws.
Filter paper.
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Supply of any drug 'other than those specified in Sch. * on a

Funnels, glass.
prescription of a RMP should be recorded at the time of supply in a
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Litmus paper (blue and red). prescription register maintained for the purpose and the serial number of
Measure glasses (cylindrical, 10 ml, 25 ml, 100 ml, and 500 ml).
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the entry in register should be entered on the prescription. Following

Mortars and pestles (glass and wedgewood).
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Ointment pots with bakelite or suitable caps. particulars should be entered in the register:
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Ointment slab (porcelain). 1. Serial number of the entry.

Pipettes (graduated, 2 ml, 5 ml and 10 ml).
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2. The date of supply.
Ring, stand (retort) iron, complete with rings.
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3. Name and address of prescriber.

Rubber stamps and pad.
Scissors. 4. Name and address of patient or name and address of owner of the
animal if drug is supplied for veterinary use.
Spatulas (rubber or vulcanite).
Spatulas (stainless steel). 5. Name ant quantity of drug.
Spirit lamp.
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Insta - Study_Pharmacy_29
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44
Pharmacy PHARMACEUTICAL JURISPRUDENCE Ch-4 DRUGS AND COSMETICS ACT
AND RULES
45

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6. In case of 'Sch. H and X drugs' the name of manufacturer, its batch A prescription for Schedule H or X drugs should
number and expiry date, if any. signed by the prescriber and dated by him; and () be in writing and
(ii) specify the name and
address of the owner of the animal if the drug is

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7 Signature of registered:pharmacist under whose supervision medi- meant for veterinary use;
cine was made or supplied. and (i) indicate the total amount of medicine
to be given.
to be supplied and the dose
If the drugs are not compounded in the premises and are supplied in

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the original container, then particulars specified in 1 to 6 above may be Supply of drugs specified in Schedule H
or X to RMP, hospitals,
dispensaries and nursing homes shall be made

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entered in a cash or credit memo book. only
written order which should be preserved by licensee against signed and
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In case of refill prescriptions it shall be sufficient if new entry in the for a period of 2
years.
register included a serial number, date of supply, quantity supplied and a

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reference to entry when drug was dispensed- on previous occasion. Prescriptions for Schedule H and X drugs
must not be dispensed more
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than once unless prescriber has stated thereon

It is not necessary to record particulars in the register or cash or credit that it may be dispensed
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more than once; however it may
memo in respect of be dispensed at stated number of times or
at stated intervals of time in accordance with
1. Drugs supplied against prescriptions under the Employee's State Name and address of seller and date of the directions of prescriber.
dispensing must be noted on the
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Insurance Scheme if all particulars are given on the prescription; prescription above the signature of the prescriber,
at the time of dispens-
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and ing.
2. Any drug 'other than those specified in Sch. C and H' if it is No person dispensing a prescription
Supplied in the original container. containing substances specified in
Schedule H and X may supply any substitute.
Supply of schedule C and C1 drugs Retail supply of such drugs except Substances specified in Schedule X should be
on a prescription of a RMP should be recorded at the time of supply in cupboard or drawer reserved solely for
stored under lock and key
the storage of these substances;
either: or in a part of the premises separate from
the remainder of the premises
) in a register maintained for this purpose in which following and for which only responsible persons have access.
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particulars should be entered: Supply of Schedule X drugs should be recorded
1. serial number of entry; a bound and serially numbered register at the time of supply in
maintained for this purpose and
2. date of supply: separate pages should be allotted for each drug.
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The following particulars
3. name and address of purchaser; should be entered in the said register:
4. name and quantity of drug; 1. Date of purchase;
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5. name of manufacturer, batch number and date of expiry;
2. Quantity received, if any, name and address of supplier and
6. signature of person under whose supervision drug was sold; or
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licence number of supplier;
(i) in a cash or credit memo book, serially numbered, containing all
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the particulars specified in items (1) to (6) above.

3. Name and quantity of drug supplied;
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4. Manufacturer's name, batch or lot number;
Carbon copies of the cash or credit memo retained by licensee should
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be maintained in a legible manner. Option to maintain a register or a cash 5. Name and address of patient/purchaser;
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or credit memo book should be made in writing to the licensing authority. 6. Reference number of prescription
against which supplies were
made;
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Supply of schedule H and X drugs Substan ces specified in Schedule H

or X should not be sold by retail except on the prescription of a RMP 7. Bill number and date of receipt of purchase
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and and supply made by
in case of substances specified in Schedule X, prescriptions should him; and
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be in
duplicate, one copy of which shall be retained by the licensee for a period 8. Signature of pëison 'under whose supervision
of 2 years. drugs have been
supplied.
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Insta - Study_Pharmacy_29
Telegram46- Study Pharmacy PHARMACEUTICAL JURISPRUDENCE
Ch-4 DRUGS AND COSMETICS ACT AND RULES

OFFENCES AND PENALTIES !

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Storage of veterinary drugs Veterinary drugs should be stored: Penalties
() in a cupboard or drawer reserved for the storage of veterinary

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offences First Convictitn Subsequent Conviction
drugs: or
of the
(1) (2) (3)
(i) in a portion of the premises separated from the remainder

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premises to which customers are not permitted to have access. A. Manufacture and Sale of Drugs

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1. Manufacture, sale, distribution, stocking, exhibition, offering for sale
Cancellation and suspension of licences If licensee fails to comply
or
Act or distribution of
with the conditions of the licence or with any provisions of the
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may, after giving licensee an opportu- (a) any adulterated or

rules thereunder, licensing authority

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of drugs or spurious drug or drug
nity to represent, cancel a licence for sale and distribution
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fit, either wholy or in respect of not of standard qual-

suspend it for such period as he thinks ity; imprisonment for a minimum imprisonment upto
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some of the substances to wrich it relates; of 10 years extending upto 10 years or fine upto
consequence of any act 20,000 or both.
If, however, such failure or contravention is the life imprisonment and fine
on the part of an agent or employee the licence shall not be of not less 10 lakh or three
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or omission
proved to the satisfaction of the times value of confiscated
cancelled or suspended if the licensee
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drugs, whichever is more.
licensing authority that-
by him or, if
(a) the act or omission was not instigated or connived at (6) adulterated drug but Provided that the fine thus collected shall be paid as
or company, by a partner of the firm or a not containing any compensation to the person who used the adulterated
licensee be a fim or spunious drugs referred above.
director of the company: or toxic or harmful sub-
(6) that he or his agent or employee had not been guilty of
any stance which may imprisonment from not less imprisonment from 2 to
on which render it injurious to than 3 years extending upto 4 years and fine of not
similar act or omission within 12 months before the date health; five years and fine of not less than R 10,000 how-
act or omission in question took place, or where agent or employee r less than one lakh or three ever the court may for
had been guilty of any such act or omission, licensee had not
or
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times vaue of confiscated adequate and special
could not' reasonably have had, knowledge of that previous
act or )without a licence. drugs, whichever is more. reason to be recorded
The Court may however for in judgment award im-
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omission; or
he had not or could any adequate and special prisonment for less than
() if the act or omission was a continuing one, previous act or omis- reason to be recorded in the 2 years and fine of less
not reasonably have had knowledge of that Judgment impose a term of than 7 10,000.
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(d) spurious drugs but not
sion, or mpnsonment of less than a
conditions of licence manufactured under
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(d) that he had used due diligence to ensure that were observed. the name of any other year and a lesser fine.
made thereunder
or or ales
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provisions of Act F
drug. imprisonment for not less imprisonment for not
may be made to the
An appeal against cancellation or suspension order than 7 years which may ex- less than 6 years to 10
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Government within 3 months. tend to imprisonment for life years and fine of not
State
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and fine of not less than R 3 less than 10,000.

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of Ayurvedic Drugs i lakh or three times value of
Sale confiscated drugs, whichever
Ayurvedic (including Sidha) and Unani.drugs were brought within the
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is more. However the court

purview of Drugs and Cosmetic Act and Rules in 1964.
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may award imprisonment for
A licence is not necessary for the sale of any Ayurvedic, Sidha
or Unani less than 7 years but not
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to
drug provided the drugs are manufactured by a persqnicen 2d manufac less than 3 years and fine of
ture drugs under the Act. not less than 1 lakh rupees.
.Continued
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Insta - Study_Pharmacy_29
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48 Pharmacy PHARMACEUTICAL JURISPRUDENCE
Ch-4 DRUGS AND CoSMETICS ACT AND RULES
49

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(1) (2) 3) Sale of Homoeopathic Medicines
imprisonment for 2 to Licence for the sale of homoeopathic medicines can be obtained by
(e) any other contraven- imprisonment from not less

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4 years or fine of not
tion of this chapter than. 1 year which may ex- making an application accompanied by the requisite fee to the licensing
of the Act and the tend to 2 years and fine not less than 5,000 or authority appointed by the State Government. Application is to be made
less than 7 20,000. The both. in Form 19-B and licence is issued in Form 20-C or 20-D for retail or

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rule thereunder.
court may however, for any wholesale, respectively. If medicines are sold in more than one place,
adequate and special reason

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separate licence should be obtained in respect of each place. Sale premises
to be recorded in judgment,
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should be clean. Premises for retail sale should be under the charge of a
award imprisonment for less
competent parson. A practising homoeopathic medical practitioner can not

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than 1 year.
imprisonment upto 1 year or fine not less than deal in premises where such medicines are sold. Licensee should pemit an
2. Not disclosing the
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name of a manufac- 20,000 or both. Inspector to inspect the premises. He should also maintáin records of
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turer or the place purchase and sale of homoeopathic medicines containing alcohol together
where the manufac with names and addresses of parties to whom sold (in case of wholesale).
tured drugs are kept. No records of retail sale need be maintained in respect of homoeopathic
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3. Not keeping records imprisonment upto 1 year or fine not less than potentised preparations in containers of 30 ml or less capacity and in
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of manufacture or 20,000 or both. respect of mother tinctures made up in quantities up to 60 ml.
sale of drugs in the Other rules relating to duration, cancellation and suspension of licences
special manner. are similar to those for allopathic drugs.
imprisonment upto 10
4. Using the report of a fine upto 5000
years or fine or both.
Government Analyst # Sale of Cosmetics
for advertising any Following classes of cosmetics are prohibited to be stocked, sold or
drug or cosmetic. exhibited for sale:
Manufacture and Sale of Cosmetics 1. Any cosmetic which is either misbranded, spurious or not of
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B.

1. Manufacture for sale, distribution, stocking, etc. of standard quality.

imprisonment upto 3 years and fine. 2. Any cosmetic containing any ingredient which may render it unsafe
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(a) spurious cosmetic
cosmetic in imprisonment upto 1 year or fine upto 7 1,000 or or harmful for use under the directions indicated or recommended.
(b) Any other
contravention of this both. 3. Any cosmetic, which is imported or manufactured or otherwise, in
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chapter or rules there contravention of the provisions of Act and Rules.
under.
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An inspector may requirè a person not to dispose of any stock of
2. Non disclosure of imprisonment upto 1 year
or fine upto 1,000 or
cosmetics.
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ame of a manufac both.

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urer or place where
manufactured cosmet-
# Disposal of Drugs if License is Cancelted i
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1. If licensee wishes to dispose of the drugs in his possession in the

ics are kept.
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the imprisonment upto 3 years and fine upto 7 5,000. premises in respect of which the license has been cancelled, he
3. Not keeping
records of manufac- should apply in writing to the licensing authority giving following
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ture and sale of particulars:

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cosmetics in the (a) Name and address of person to whom drugs are proposed to be
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specified manner. sold and his licens imbtr.

(6) Names of drugs together with their quantities, batch numbers,
names and addresses of manufactures and dates of their
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Insta - Study_Pharmacy_29
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50
Pharmacy PHARMACEUTICAL JURISPRUDENCE
Ch-4

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DRUGS AND coSMETICs ACT AND RULES
51
expiry, if any, proposed to be sold to the person mentioned
Specimen Label of Schedule G Drug

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above.
2. Licensing authority may, after examination of the particulars fur- 10 x 10 Tablets
nished and if necessary, after inspection by an inspector of the BUSULPHAN TABLETS I.P.

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premises, where the drugs are stocked, grant necessary permission Each tablet contains:

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for their disposal.
Busulphan I.P. .5 mg
Date expired drugs : Date expired drugs should be destroyed at the
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Keep in a well closed container, protected from light

premises of licensee in whose possession drugs have expired. Expired

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Caution: It is dangerous to take this preparation
drugs are to be destroyed at premises of licensee within 3 months from the
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expiry date instead of returning them to the manufacturers.

except under medical supervision.
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Drugs or cosmetics in respect of which an offence is committed are Dosage
liable to confiscation together with any implement or machinery used in 1 to 4 tablets a day in divided doses or as directed by the physician
the manufacture, sale or distribution, and any receptacle, packing or
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Mfg. Lic. No. : 859
coverings in which such drug in contained and the animals, vehicles,
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Batch No.: 015 Retail price not
vessels or other conveyances used in carrying such drug or cosmetic. Drugs Mfg. date : xx-xx-xx to exceed ....
or cosmetics which are found to be not of standard quality, or adulterated Exp. date : y-yy-y Local taxes extra
or spurious, are also liable to confiscation. Confiscate means to officially
take private property away from someone, usually as a punishment. SANJIV PHARMACEUTICALS (PVT.) LTD.,
Mere storage of medicines of expired date is not an offence unless MUMBAI 400040 INDJA
evidence is given otherwise. Where a particular niedicine is kept in the
shop there will be a presumption that it is there for the purpose of sale
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unless that presumption is rebutted by the accused. Specimen Label of Schedute G Drug for Parenteral use
10x2ml
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LABELING AND PACKING OF DRUGS
PHENIRAMINE MALEATE INJECTION
General Labeling Requirements (Antihistaminic & Antiallergic preparation)
Containers of all drugs and medicines are to be labeled according to
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Each ml contains:
Drugs and Cosmetics Rules 1945. Following particulars should be, either
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Pheniramine Maleate I.P. 22.75 mg
printed or written in indelible ink and should appear in a conspicuous Water for injection I.P.
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q.S.
manner. on the label of the inner most container of any drug and on every
other covering in which the container is packed:-
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Caution: It is dangerous to take this preparation
1. Name of the drug. Proper name of drug should be printed in
a
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except under medical supervision.

manner than trade name, if any.
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more conspicuous
2. Correct statement of the net contents in terms of weight, measure, For i.m. or slow i.v. injection
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volume, number of units of activity, as the case may be, are expressed in Dosage: As directed by the physician.
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metric system. Mfg. Lic. No.: ZP/99/B7
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3. Content of active ingredients: Batch No. PY797D

(a) For oral liquid preparations- in terms of the onteiit per single Mfg.date: XXXX Retail price not to exceed
dose i.e. 5 ml or multiple thereof. Where the dose is below 5 Exp.date: YYYY Local taxes extra
ml the contents of active ingredients may be expressed in
terms of one ml or fraction thereof.
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Insta - Study_Pharmacy_29
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52
Pharmacy PHARMACEUTICAL JURISPRUDENCE
Ch-4 DRUGS AND COSMETICS ACT AND RULES
53

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Specimen Label of Schedule G & H Drug
Specimen Label of Schedule H Drug
6 Tablets

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10 Tablets Fexofenadine Hydrochloride Tablets
RORITHROMYCIN Tablets NKFEX 180 mg
Each film coated tablet contains:

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Each film coated tablet contains: Fexofenadine Hydrochloride 180 mg
Roxithromycin BP 50mg
Colour: Yellow iron oxide, Red iron oxide, & Titanium Dioxide I.P.

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Excipients q.S.
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Keep in a cool, dry place. Protect from light. Caution :

It is dangerous to take this prepara-
tion except under medical supervision.

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SCHEDULE DRU
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SCHEDULE 'H' DRUG

Warning: To be sold by retail on the prescription of a RMP only. Warming: To be sold by retail on the prescription of a RMP only.
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|

Dosage:As directed by the physician. Store in a cool place

DOSAGE As directed by the physician.
Mfg. Lic. No.: PYZ/002
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Retail price not to Mfg. Lic. No.: B/999
Batch No.: B29/99
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XXX exceed Batch No.: 070727
Mfg.date:
YYY Local taxes extra Mfg.date: JAN 2003 Retail price not to exceed .
Exp.date:
Exp.date DEC. 2004 LT extra
Proton Remedies Ltd. Vadodara (390 007) Bulbul Pharma Ltd., Clive Road, Kolkata, INDIA
Specimen Label of Schedule H Drug (Parenteral use) Specimen Label of Schedule 6 & H Drug
100 ml 100 ml
Ofloxacin Infusion
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B JAINIDREXCough syrup
[Joflox i.v.] [Antitussive+Decongestant+Antiallergic]
Each 5ml contains:
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Each 100 ml contains: SINGLE DOSE CONTAINER
Ofloxacin U.S.P. 200mg PYROGEN FREE Dexomethorphan Hydrobromide I.P. 10 mg
Sodium chloride .9g STERILE Phenylpropanolamine Hydrochloride B.P. 12.5 mg
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Water for injection q.S. For i.v.use Diphenhydramine Hydrochloride I.P. 8 mg
Flavoured syrupy base q.S.
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Keep in a cool, dry place. Protect from light.
Caution :It is dangerous to take this prepa-
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SCHEDULE H' DRUG ration except under medical supervision.

Warning: To be sold by retail on the prescription of a RMP only.
=
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SCHEDULE 'H' DRUG
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Waming: To be sold by retail on the prescription of a RMP only.

Caution : Not to be used if container is found leaking or
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solution is not clear or contains visible solid particles. DOSAGE:As directed by the physician.
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Keep out of reach of children to prevent overdosing

DOSAGE: As directed by the physician.
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Mfg. Lic. No.: GUJ/DC/03
Mfg. Lic. No.: BOM/DC/01
Batch No. 99/B3/77D
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Batch No. NKI/FOR/B7 Retail price not to exceed Mfg.date:

Mfg.date: mmddyy Local taxes extra
ABCABC Retl pnte not to exceed **
Exp.date: BACBAC Local taxes extra
Exp.date yyddmm
PULSAR PHARMA. Ltd. Vadodara (390009)
PLANET Pharmaceuticals Ltd. Ahmedabad (380 G04)
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Insta - Study_Pharmacy_29
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Ch-4 DRUGS AND COSMETICS ACT AND RULES 55

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Specimen Label of ScheduleH Drug falling under Specimen label of schedule X Drugs
Narcotic Drugs & Psychotropic Substances Act

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5 ml
NR 10 Tablets
X PENTOBARBITONE SODIUM INJECTION USP
NIMESULIDE FLÄVOURED DISPERSIBLE TABLETS

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Each ml contains:
[NimuDisp]1 Pentobarbitone U.S.P 50 mg

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Each uncoated flavored dispersible tablet For Intramuscular Injection only
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contains Nimesulide BP 100 mg Schedule X Drug

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sCHEDULE H DRUG Warning: To be sold by retail on the Warning: To be sold by retail on the prescription of a Rgistered
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Medical Practitioner only. The injection should be

prescription of a Registered Medical Practitioner only.
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discarded if any precipitate is observed.
DOSAGE: As directed by the physician. DOSAGE
1 to intramuscularly or as directed by the physician.
5 ml
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Store in a cool, dry and dark place.
Discard the remaining solution after use.
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Mfg. Lic. No.:
Mfg. Lic. No. : 789
Batch No.
Mfg.date:
Exp.date:
Retail price not to exceed....
Local taxes extra
Batch No.
Mfg.
Exp.
date exceed ..
Retail price not t0

datee: Local Taxes Extra

Karishma Ltd., Fort Road, Bangalore Swamy Pharma Pvt. Ltd., Chennai

Specimen Label of Schedule H Drug under Specimen labels of combination X Drugs

Narcotic Drugs & Psychotropic Substances Act
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- 5 ml
*NR 10 Tablets XB Analgin and Pentobarbital Sodium Injection
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Esomeprazole Magnesium Delayed Release Tablets Each ml contains:
ES-OD20 Analgin I.P. 00 mg
Pentobarbital Sodium I.P. 20 Mg
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Each enteric coated tablet contains:
Esomeprazole Magnesium equivalent to Esomeprazole 20 mg For Intramuscular Injection only.
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Excipients q.S. Store protected from light
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SCHEDULE 'H' DRUG Schedule X & "*' Drug

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Warning: To be sold by reiail on the prescription of a RMP only. Warning: To be sold by retail on the prescription
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of a Registered Medical Practitioner only.

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DOSAGE: As directed by the physician.
dark place Dosage 1 to 5 ml a day or as directed by the physician.
Store in a cool, dry &
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Mfg. Lic. No. : 789

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Mfg. Lic. No.:
Batch No.:
.. Batch N0. : Retail price not to
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Retail price not to exceed

Mfg. date exceed ...
Mfg.date:
Local taxes extra
Exp. date Local Taxes Extra
Exp.date:
Monaco ABC Pharmaceuticals, Mumbai 400098
Jetha Pharmaceuticals (Pvt)Ltd. Varodara-390077
To print in red colour.
*To print in red colour.
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56 Pharmacy PHARMACEUTnCAL JURISPRUDENCE Ch-4 DRUGS AND COSMETICS ACT AND RULES
57

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Specimen Label of External Use Preparation-Powder (6) For liquid preparations ready for administration- interms of 1
ml or percentage by volume or per dose in the case of a single
NEOBACSULF 10 g

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dose container. If preparati n is contained in an ampoule,
ISprinkling powder] composition may be shown or label or wrapper affixed to any
package in which such amp:ule is issued for sale.

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Each gram contains:
Neomycin sulfate IP 5 mg (Forin terms
drugs in solid form inteaded for parenteral administration-

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Bacitracin IP 250 units of units or weight per mg or grammne.
Sulphacetamide 60 mg () For tablets, capsules, pills etc.- in terms of content in each
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unit.

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FoR EXTERNAL USE ONLY (e) For other preparations- in terms of percentage by weight or
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volume or in terms of units per gramme or ml

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Mfg. Lic. No.: 4: Name and address of the manufacturer.
Retail price not to
In case of the drug
Batch No.
Mfg.date: exceed .. contained in an ampoule or a similar small container it is enough if only
the name of the manufacturer and his principal place of business are
Local tax extra
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Exp.date:
shown.
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Manufactured by: PUREX LIMITED, MUMBAI 400 070 5. Manufacturing License Number, or Mfg. Lic. No. or M.L.
6. A distinctive batch number, the figure representing the batch
number being preceded by the words 'Batch No, or 'B. No', or 'Batch' or
Specimen Label of External Use Preparation-Lotion 'Lot No.' or Lot.
CALDIPHEN 50 ml 7. Label of innermost container of the following categories of drugs
Calamine & Diphenhydramine Hydrochloride Lotion and every other covering in which the container is packed shall bear a
A soothing lotion for the relief of itching due to
conspicuous red vertical line on the left side running throughout the body
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of the label (not less than 1 mm in width) without disturbing other printed
Sunburns, Prickly heat, Insect Bites, Minor skin irritation. conditions on the label:
Contains:
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Narcotic analgesics, hypnotics, sedatives, tranquillizers, corticosteroids,
Calamine 1.P. 5mg
Diphenhydramine hydrochloride L.P. : 250 units hormones, hypoglycemics, antimicrobials, antiepileptics, antidepressants,
anticoagulants, anti-cancer drugs and ali other drugs under Schedules G, H
0.1% w/v
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Camphor B.P.
Specially denatured spirit 2.37% v/v and X.
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With glycerin base These provisions shall not apply to (a) preparations intended for animal
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treatment or external use; (b) ophthalmic preparations and ear drops; and
SHAKE WELL BEFORE USE FOR EXTERNAL USE ONLY (c) preparations intended for parenteral use and sterile preparations such
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as sutures, surgical dressings.
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Warning: Should not be applied to blistered raw or oozing areas 8. Expiry particulars, if any.
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of skin. If burning sensation results use should be discontinued.
Easily removed from skin surfaces by washing with water. 9. Precautionary information related to care in handting, use, distri-
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bution etc.
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Mfg. Lic. No. 10. Information related to storage or manner of use.
Batch No. Retail price (not to exceed):
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Mfg.date Local taxes extra 11. General information such as 'Physizii's simple, not for sale' etc.
Exp.date
Manufactured by: Health Remedies, Thane
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Insta - Study_Pharmacy_29 .1

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58
PHARMACEUTICAL JURISPRUDENCE Ch-4 DRUGS AND COSMETICS ACT AND RULES 59

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Special Labeling Requirements (1) (2)
2. "Schedule X Drugs Waming: To

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Class and Nature of Medicine5 Particulars Which Should
be sold by retail on the presciption
in Which Contained Appear on Label of a Registered Medical Practitioner

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2) only."
(1)
Schedule

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X 1. Symbol X given conspicuously
Schedule C1 Bulk form in red.
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Sch Cdrugs and their 1. Date of manufacture

preparations including 2. Date of expiry Schedule P 1. Date of manufacture.

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combinations with 3. Import license number, if applicable. Any drug 2. Date of expiry of the potency.
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other drugs Schedute C 1. Proper name of the substance in

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Schedute F F The prescribed name. In original form addition to any patent or proprietary
name.
Schedule G The words "Caution. It is dangerous to take
2. License No. under which
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Medicines made up ready for this preparation except under medical manufactured or imported.
and
internal use in the treatment supervision", be conspicuously printed
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by a line within which there 3. Batch No. or Lot. No.
of human ailments. surrounded 4. Statement of potency in units,
should be no other words. wherever required by the Rules
Schedule H 1. Symbol conspicuously displayed 5. Name and address of the
Medicines made up ready on the left top corner of the label. manufacturer of final product
for internal use of human 2. "Schedule H Drug Waming: To be 6. Date of manufacture.
beings. sold by retail on the prescription of a 7. If a test for maximum toxicity is
Registered Medical Practitioner only". prescribed, a statement that the drug
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has passed the test.
Schedule H 1. Symbol N conspicuously displayed
8. Date of expiry wherever prescribed.
Falling under Dangerous on the left top corner of the label.
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9. Nature and percentage of antiseptic
Drugs Act, 1930. 2. "Schedule H Drug - Warming: To be added, if any.
sold by retail on the prescription of a
10. Precautions necessary for preserv-
Registered Medical Practitioner only."
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ing the properties of the drug.
1. Symbolwhich shall be in red and
Rx
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Schedule H1 Schedule G 1. Proper name
Certain 3rd. and 4th generation conspicuously displayed on the
Any Drug 2. Manufacturing or import license No.
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antibiotics, certain habit left top corner of the label. 3. Batch No.
2. "Schedule H1 Drug-Warning It is
:
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forning drugs and 4. Potency in units.
dangerous to take this preparation
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anti-TB drugs. 5. Date of expiry.

except in accordance with the
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medical advice. Schedule w
3. Not to be sold by retail without the Single ingredient Proper name (no trade name)
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prescription of a Registered Medical

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Preparations containing new Generic name only
Practitioner. drug as single ingredient
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1. Symbol N in red, conspicuously

Schedule X
Patent and proprietary 1. Quantities of the active ingredients.
Medicine made up ready for displayed on left top corner of the
internal use of human beings. iabel 2. Name and address of manufacturer.
-..continued
.continued
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Insta - Study_Pharmacy_29
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60 PHARMACEUTICAL JURISPRUDENCE
Ch-4 DRUGS AND COSMETICS ACT AND RULES
61

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(1) (2)
(1) (2)
Patent&proprietary contain- 1. "For Prophylactic use"

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ing vitamins for prophylactic or antiseptic or other liquid
or therapeutic use 2. "For Therapeutic use" medicine

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Non-surgical ligature and The words, "Non-sterile surgical Ophthalmic ointments 1. Special instructions regarding storage,
suture ligature (suture)-not to be used for wherever applicable.

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operations upon the human body 2. Warning: If irritation persists or
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unless effectively sterilised," printed increases discontinue the use and

consult the physician.

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conspicuously in indelible red ink.
Medicines for animals
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Pharmacopæial and other 1. Name or synonym as specified in 1. The words, Not. for húman use.
Medicines made up ready for For animal treatment only.
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drugs the Pharmacopaeia followed by the
letters-T.P., "B.P., B.P.C., U.S.P., the treatment of animals 2. Symbol depicting the head of a
N.F, etc. as the case may be, or domestic animal.
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description of the substance (proper Medicines containing methylated spirit
name being not les conspcuous than
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Medicines made up ready for
trade name, if any) the treatment of human FOR EXTERNAL USE ONLY.
2. Net amount of the drug in terms of ailments and containing
weight or measure in metrc system or industrial methylated spirit.
units of activity or in case of tablets,
capsules etc., the quantity in each. Disinfectants 1. Name of the product and name and
3. Amounts of active ingredients (content address of the manufacturer.
per single dose in oral preparations 2. Grade, type and Rideal Walker coeffi-
and in terms of volume in case of cient of the product.
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parenteral preparations). For prepara- 3. Date of manufacture and expiry
tions of antibiotics, hormones and 4. Quantity in the container.
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other drugs for parenteral use whose 5. Indications and mode of use.
dosage is expressed in units or by Mechanical contraceptives 1. Particulars specified in Schedule R.
weight: total units or quantity in
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2. Date of manufacture and date up too
each container or number of units or which it is expected to retain its
weight per g or ml (not necessary in
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properties.
case of pharmacopoeial preparations).
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3. Storage conditions.
4. Name and address of manufacturer.
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5. Manufacturing License No. & Batch No. Oral contreceptives Date of manufacture.
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Alcoholic preparations Statement of quantity of alcohol as Coloured medicaments Common name and % of colour.
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Any drug, containing average % of absolute alcohol by Replaced containers Name of the drug and its quantity,
more than 3% v/v alcohol. volume.
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Drugs supplied in containers name and address of the seller.

Preparations for external application other than the one in which it
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such as embrocation, is marketed by the manufacturer
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liniment, lotion, ointment, FOR EXTERNAL USE ONLY

Drug samples The words, Phiýsician's Sample,
antiseptic cream, liquid Drugs for free distribution to Not to be sold'.
.Continued the mdical profession
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Insta - Study_Pharmacy_29 -

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62
PHARMACEUTICAL JURISPRUDENCE
Ch-4 DRUGS AND COSMETICS ACT AND RULES 63

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Provided that this shall not apply to packings meant for use of a
Exemptions (1) Labels on packages or containers of drugs for export hospital/dispensary subject to the condition that (i) supplies are made by
should be adapted to meet specific requirements of law of the importing

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the manufacturers/distributors direct to the hospital/dispensary, and
country. However following particulars shall appear in a conspicuous i) hospital packs shatl not be supplied to a retail dealer or to a RMP.
position on innermost container in which drug is packed and every other

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covering in which that container is packed: Labeling of Ayurvedic and Unani Drugs Label of the container of
package of an ayurvedic or unani drug should contain following particu-

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(a) Name of drug;: (6) Name, address of manufacturer and license lars:
number under which drug has been manufactured; (c) Batch or lot number:
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1. True list of all ingredients used in manufacture of the preparation

(d) Date of expiry, if any.

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together with quantity of each ingredient and a reference to the
Provided that where a drug, not classified under Schedule F, F1 and X, method of preparation as mentioned in authoritative books speci
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blood products, narcotic and psychotropic substances is required by the fied in the First Schedule. If list of ingredients ,be too large the
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consignee not to be labeled with name and address of manufacturer, the same may be printed separately and enclosed with packing and a
labels on packages or containers shalU bear a code number approved by the reference to this effect be made on label.
Licensing Authority.
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2. The words, Caution. To be taken under medical supervision both in
(2) A medicine made up ready for treatment, whether after or without English and Hindi must appear on container of a medicine for
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dilution, supplied on prescription of a RMP provided that it is labeled with internal use made up ready for the treatment of human ailments
following particulars: containing a substance specified in Sch. E1.
(a) Name and address of supplier; (6) Name of patient and quantity of 3. Name of drug as specified in literature in First Schedule.
medicine; (c) Serial number of entry in prescription register; (d) Dose of 4. Net contents in terms of weight, measure or number expressed in
medicine if for internal use; (e) Words "For External Use Only" on label if metric system.
medicine is for external application.
5. Name and address of the manufacturer.
Packing of drugs Pack sizes of drugs meant for retail sale shall be as
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6. Manufacturing licence number being preceded by the words Manu-
prescribed in Schedule P1 to the rules, and for other drugs, as given facturing Licence Number, or Mfg. Lic. No. or M.L.
below:
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Less than 10 tablets/capsules Packing by integral number 7. Batch number or Lot number or any distinguishing prefix.
()
More than 10 tablets/capsules Multiples of 5 8. Date of manufacture.
Liquid oral preparations 30 ml (pediatri only) 9. The words Ayurvedic medicine or Sidha medicine or Unani medicine,
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()
60 ml/100 ml/ 200 ml/ 450 ml as the case may be,
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(n) Paediatric oral drops 5 ml / 10 ml / 15 ml
10. Words for extermal use only if the medicine is for external applica-
3 ml/5 ml / 10 ml
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(iv) Eye/ear/nasal drops tion.

() Eye ointment 3 g/5 g/ 10 g
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11. Words Physician's sample. Not to be sold if drug is intended for free
However these provisions shall not apply to (i) imported formulations in
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distribution to medical profession.

finished form; (i) preparations for veterinary use; (ii) preparations for
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Any transparent cover, wrapper case or other covering used solely for
export; (iv) vitamins/tonics/cough preparations/antacids/laxatives in liquid
oral forms/unit dose forms; (v) physician's samples, pack sizes of dosage
the purpose of packing, transport or delivery do not require any labeling.
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forms for retail saleto hospitals; RMPs, nursing homes; and (vi) pack sizes Labeling of Homoeopathic Medicines Following particulars must
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of large volume IV fluids. appear in a conspicuous manner on the label of innermost container of any
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Schedule X drugs shall be marketed in packings not exceeding: Homoeopathic medicine and on every other covering in which container is
() 100 unit doses in the case of tablets/capsules; packed:
(i) 300 ml in the case of oral liquid preparations; 1. Words 'Homoeopathic medicine';
(in) 5 ml in case of injections.
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64
Pharmacy PHARMACEUTICAL JURISPRUDENCE Ch-4 DRUGS AND COSMETICS ACT AND RULES 65

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(d) Batch number preceded by the letter "B"
2. Name of medicine as specified in the Homoeopathic Pharmacopeias (not necessary if the cosmetic is 10 g or
of U.S.A., U.K. or Germany and for drugs not specified in these

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less: or 25 ml or less)
books; a name descriptive of true nature of the drug;
(e) Manufacturing licence number preceded by
3. Potency of medicine in decimal, centesimal or millesimal systems; letter "M". If the package has only one label

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4. In case of a medicine containing two or more ingredients,
name of atl information required on inner and outer

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each ingredient and its potency or proportion; label should appear on such label only.
a medicine is not
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5. Name and address of manufacturer or in case

sold in its original container, name and address of seller; Hair dyes containing coal-tar colours

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alcohol by volume in terms of ethyl alcohol, in case On inner and outer label caution. The product contains ingredients
6. Percentage of
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of medicines containing alcohol, however, if medicines

are con which may cause skin iritation in certain
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cases and so a preliminary test according to
tained in containers up to 30 ml. alcohol content need not
be
mentioned; the accompanying directions should first be
or "Batch", or "Lot made. This product should not be used for
7. Batch number preceded by words "Batch No",
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dyeing the eyelashes or eyebrows as such a
Number" or "Lot No." or "Lot" or any distinguishing prefix,
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use may cause blindness.
"Manufactur-
8. Manufacturing licence number preceded by the words Each package should aso contain following instructions in English and
or "Mfg. Lic. No." or "M. L."
ing Licence Number, local languages:
more than one
9. Proprietary name in case of medicines containing This preparation may cause serious inflammation of the skin in some
ingredient. cases and so a preliminary test should always be caried out to determine
Labeling of cosmetics Cosmetics, whether imported or manufactured whether or not special sensitivity exists. To make the test, leanse a small
in India, must be labeled according to following provisions- area of skin behind the ear or upon the inner surface of the forearm, using
either soap or water or alcohol. Apply a small quantity of the hair dye as
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Labeling of Cosmetics in general prepared for use of the area and allow it to dry. After 24 hours, wash the
On both the inner (a) Name of cosmetic, area gently with soap and water. If no imitation or infiammation is apparent,
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and outer labels (6) Name and principal place of business of manu- it may be assumed that no hypersensitivity to the dye exists. The test
facturer. should, however, be caried out before each and every application. This
preparation should on no account be used for dyeing eyebrows or eyelashes
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On the outer label A declaration of net contents expressed in
as severe inflammation of the eye or even blindness may result.
terms of weight for solids, fluid measures for
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liquids, weights for semi-solids, combined Tooth paste containing Fluoride
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with numerical count if the content is sub On tube and carton Fluoride content in ppm (not more than
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divided (not necessary in case of a package 1000 ppm) and date of expiry.
of perfume, toilet water etc. whose net con-
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tent does not exceed 60 ml or any package Standards for cosmetics: Following cosmetics in finished form shall
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of solid or semi-solid cosmetic whose con- conform to the Indian Standard specifications laid down from time to time
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tent do not exceed 30 g.) by Bureau of Indian Standards (BIS)-(Schedule S under Rules)
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On the inner label (a) Adequate direction for safe use. 1. Skin Powders, 2. Skin Powder for infants, 3. Tooth Powder,
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4. Toothpaste, 5. Skin Creams, 6. Hair 0ils, 7. Shams/2o, oap-based.

where a hazard exists (6) Any warning, caution or special direction 8. Shampoo, Synthetic-Detergent based, 9. Hair Creams, 10. 0xidation hair
required to be observed by consumer.
dyes, Liquid, 11. Cologne, 12 Nail Polish (Nail Enamel), 13. After Shave
(c) A statement of names and quantities of poi-
iotion, 14. Pomades and Brilliantines, 15. Depilatories chemicals,
Sonous ingredients.
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66
PHARMACEUTICAL JURISPRUDENCE Ch-4 DRUGS AND COSMETICS ACT AND RULES 67

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18. Lipstick, 19. Toilet Soap,
16. Shaving Creams, 17. Cosmetic Pencils,
Class Standards
20. Liquid Toilet Soap, 21. Baby Toilet Soap, 22. Shaving Soap. Veterinary drugs Standards given in current edition of British Veteri-

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Powder Hair Dye IS:
23. Transparent Toilet Soap, 24. Lipsalve IS:10284, 25. nary Codex.
Bindi (Liquid) IS 10998, 27. Kum Kum Powde IS: 10999,
10350, 26. Substances (other than food)
28. Henna Powder IS: 11142, 29. Bathing Bars IS:13498:1997

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intended to affect the struc
ture or any function of

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MISCELLANEOUS human body:
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i () mechanical Standards laid down in Schedule R.

Standards of Drugs and Cosmetics
- contraceptives

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Class Standards i) other contraceptives Standards should be in conformity with: the formula
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Standards for identity, purity and strength as speci- approved as safe and efficacious by the Central Gov-
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Drugs included in
fied in current or eartier edition of I.P. ernment
Indian Phamacopceia
Drugs not included in Stamdards for identity, purity and strength as speci Substances intended to be
which
fied in official Pharmacopoeia of any country to used for the destruction of
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Indian Pharmacopeia or
drug daims to comply with, or included in B.P.C. vermin or insects which couse
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N.F. (US.) disease in human beings or
animals:
Patent or proprietary General requirements of the respective dosage form
medicines-dosage foms including compliance of colour, consistency. clarity, Disinfectants Standards laid down in Schedule 0.
stability, freedom from contamination with foreign Ophthalmic preparations Standards laid down in Schedule FF of Rules and in
matter or fungal growth, defects like chipping and the Second Schedule to the Act.
capping of tablets, cracking of the coating, mottled Substances specified in Standards of strength, quality and purity as laid
appearance and other characteristic defects that can Schedule C and C1. down in Rules and in Schedule F or Fi as the case may
in IP
be perceived by visual inspection; as prescribed be.
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or other Pharmacopceia.
per- Vitamins, hormones and Standards maintained at the National Institute for
Tablets Label should indicate () nature of coating., (i) analogous preparations Medical Research, London and such other standards as
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mitted colour, if added; (ii) whether tablet is may be prescribed.
uncoated, sugar coated or film coated. Tablets shall
also comply with standards of disintegration test. Homeopathic medicines Standards laid down in current edition of Homeo
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pathic Pharmacopaeias of U.S.A. or U.K. or Germany or
Capsules Medicines shall comply with requirements of capsules for medicines not included therein, standards ap-
laid down in IP. Capsules should be free from defects
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proved by Central Government and displayed in the
like leakage of powder from joints, pinholes or cracks,
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prescribed, manner.
distortion of shape and discoloration.
Cosmetics Standards specified in Schedule S.
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Liquid oral dosage Emulsions and suspensions shall disperse uniformly
no
on shaking. Homogeneous solutions shall contain
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forms Exemptions The drugs specified in Schedule K are exempted from the
sediment. Volume of product in container shall be
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provisions relating to manufacture, sale and distribution of drugs as
not less than labeled volume. Ethanol content
of
pharmaceutical products shall be not less than 90% follows:-
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and not more than 110% of labeled

contents. 1. Drugs not intended for medicinal use
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Injections and ointments Standards laid down im IP. Exempted from all provisions relating to manufacture, sale and
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Requirements of free salicylic acid test (limit 0.75% distribution of drugs provided the drug is not sold for medical use
Aspirin preparations
except in case of soluble type aspirin imit 3%) or for use in the manufacture of medicines and that each container
.continued is labeled conspicuously with the words "not for medicinal use."
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68 PHARMACEUTICAL JURISPRUDENCE

Ch-4 DRUGS AND COSMETICS ACT AND RULES

2. Quinine and other antimalarial drugs

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69
Licence not required for persons selling drugs by retail under 5. Whole Human Blood IP and/or its components stored for transfusion

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arrangements made by State Government for sale and distribution by a First Referral Unit Community Health Centre, Primary
Health Centre
of drugs. and a Hospital:
3. Drugs supplied by a RMP to his own patients or any Schedule C License not required for operation of a blood bank or processing

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drug supplied by a RMP at the request of another RMP for the use of an Whole Human Blood and/or its components subject
to conditions

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individual patient provided the RMP is not (o) keeping an open shop or specified.
(b) selling across the counter or (c) engaged in the import, manufacture,
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6. Quinine Sulphate:
distribution or sale of drugs in India.

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It would not be considered to be misbranded, adulterated
No licence is necessary for such supply; provided drugs are pur- or
Spurious if:
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chased from licensed dealer or manufacturer and records of such () It is coloured pink with an edible pink colouring matter,
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purchases are maîntained. (i) B.P. tests for readily carbonisable substances produce a yellow
In the case of medicines containing a substance specified in colour of an intensity about four times the colour produced
Schedule G, H or X following additional conditions should be with quinine sulphate conforming to B.P. standard,
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complied: (im) Other cinchona alkaloids
present are not more than 6%; and
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Name and address of the RMP supplying the medicine should iv) Residue on incineration does not exceed 0.14%
appear on the label. 7. Homoeopathic medicines:
(i) For external use drugs the words 'For External Use Only and for
internal use drugs the 'dose': should appear on the label. Provisions relating to the manufacture, sale and distribution
pro-
(i) Names and quantities of ingredients or medicine, dose, name vided a container containing such a medicine
bears a label
of the patient, date of supply and name of the prescriber "Homoeopathic medicine.
should be entered in the register at the time of supply. 8. Magnesium sulphate:
(iv) Entry in the register should be numbered and number should Exempted from provisions of sub-clause (i) of clause
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be entered on the label. (ii) of Section
18 of the Act provided chloride present in the salt shall not exceed
(v)Register and prescription, any, should be preserved for not
if 0.12% in case of the product prepared from sea water.
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less than two years from date of last entry in the register or
9. Substances which are used both as drugs as well
date of prescription, as the case may be. as foods, such as
listed below, are exempted from the provisions relating
to the manufacture,
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4. Drugs supplied by a hospital or dispensary maintained or supported sale and distribution.
by Government or local body or by charity or voluntary subscription: () All condensed or powdered milk,
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Sale licence is not necessary subject to following conditions- (i) Farex, oats and similar cereal preparations whether
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fortified
() Dispensing and supply of drugs should be carried by or under with vitamins or not excepting those for parenteral use.
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the supervision of a qualified person; (ii) Virol, bovril, chicken essence and other similar predigested
() Inspector can inspect premises where drugs are stocked and
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foods.
may take samples; (iv) Ginger, pepper, cumin, cinnamon
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and other similar condiments
(ii) Drugs should be stored under proper storage conditions. and spices unless they are labelled to be of official
quality.
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(iv) Drugs shall be purchased from a manufacturer or a licensed

10. Substances intended to be used for
dealer. destruction of vermin or insects
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which cause isease in human beings or
(v). No drug shall be supplied/dispensed after date of expiration of animal, viz. Insecticides and
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disinfectants.
potency.
Sale licence is not necessary provided
the person selling such
substances complies with requirement of not selling
it after expiry
date or not violating any statement or direction recorded on
label
of such container.
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Insta - Study_Pharmacy_29 ***

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JURISPRUDENCE Ch-4 DRUGS AND COSMETICS ACT AND RULES

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PHARMACEUTICAL
70
A.P.C. tablets and pow 20. Sale from restaurant cars of trains and coastal ships of household
11. Household remedies like Aspirin tablets,

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gripe water, inhalers for remedies not requiring supervision of a qualified person for sale.
ders, analgesic balms, antacid preparations,
of nasal congestion, syrups, lozenges, pills and tablets Sale licence is not required but a record of purchase and sale
treatment cold and
burns, absorbent should be maintained and place where the drugs are stocked may

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ointments for
for cough, liniments, skin ointments, and
Castor oil,
cotton, wool, bandages, absorbent gauge and adhesive plaster, Tr. Benzoin be inspected by an Inspector who may also take samples for test.

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Iodine,
liquid paraffin and Epsom salt, eucalyptus oil, Tincture 21. Drugs supplied by (i) Multipurpose workers attached to Primary
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exceeding 100 ml,

Co., and mercurochrome solution in containers not Health Centres, (ii) Community Rural Health Scheme, and (m) Nurses,
quinoline
tablets of Quinine sulphate I.P., tablets of iodochloro-hydroxy

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Auxiliary Nurse, Midwives and Lady Health Visitors attached to Urban
Family Welfare Centres / Primary Welfare Centres / Primary Health Centres/
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250 mg:
Sale licence is not necessary subject to following conditions: sub-centres
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population of not more
() Drugs are sold only in a village having Sale licence is not necessary provided drugs are supplied under
than 1000 and where there is no licensed dealer
specified in Schedule G, Health or Family Welfare Programme of Central or State Govern-
do not contain any substances
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() Drugs ments.
H or X.
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containers of ticensed 22. Insect (e.g. mosquitoes) repellants:
(i) Drugs are sold in original unopened
manufacturer. Sale licence is not required provided product has been manufac-
tured under a valid drug manufacturing licence.
12. Mechanical contraceptives
Sale licence is not necessary as under 10 above. 23. Band-aid medicated dressings
Nonoxynol: Sale licence is not required provided product has been manufac-
13. Vaginal contraceptive pessaries containing
clause 17 of Rule 65 tured under a valid drug manufacturing licence.
Sale licence is not necessary if provisions of
are complied with by person stocking/selling this contraceptive.. 24. Oral rehydration salts
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14. Chemical contraceptives Sale licence is not required provided product has been manufac-
Sale licence is not necessary for Family Planning
Centres and other tured under a valid drug manufacturing licence.
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agencies approved by Government for distribution of chemical
Controlling Authorities
contraceptives. Drugs Inspectors appointed under the Act are under the control of a
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15. Cosmetics controlling authority. The qualification of a controling authority has been
origin and manufactured
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Sale licence is not necessary if of Indian prescribed under the new "Rule 5OA" by the Drugs and Cosmetics (Ninth
by licensed manufacturers.
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Amendment) Rules, 1989.

group of drugs
16. Ophthalmic ointments of tetracycline
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Qualifications of controlling authorities
Can be sold withouta licence by persons authurised by Government
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Programme.
() Graduate in Pharmacy/Pharmaceutical Chemistry/Medicine with spe-
under National Trachoma Control cialization in Clinical Pharmacology/Microbiology from a recognised
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17. Hair fixers university:; and
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Allprovisions relating to manufacture, sale and distribution. () Experience in the manufacture or testing of drugs or enforcement
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of the provisions of Act for a minimum period 5 years.
18. Radiopharmaceuticals
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All provisions relating to manufacture, sale and distibution. rugs Inspectors i

19. Tablets of Chloroquine salts The Central or State Governments are empowered to appoint Drugs
Commercial Distribu-
Sale licence is not required if sold under the Inspectors and to assign them definite areas. Any person having financial
Programme and
tion Scheme of the National Malaria Eradication interest in the import, manufacture or sale of drugs or cosmetics cannot be
duly labeled.
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Insta - Study_Pharmacy_29
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12 PHARMACEUTICAL JURISPRUDENCE Ch-4 DRUGS AND COSMETICS ACT AND RULES
13

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appointed as Drugs Inspector. Drugs Inspectors are deemed to be public C. At all reasonable times, with necessary assistance,
servants and are officially subordinate to the Controlling Authority. 1. Search any person who has secreted about his person, any drug or

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Qualifications of inspectors: For appointment as Drugs Inspectors a cosmetic in respect of which an offence relating to manufacture,
person must have a degree in Pharinacy or Pharmaceutical Sciences or sale or distribution has been or is being committed;

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Medicine with specialization in ctinical pharmacology or microbiology from 2. Enter aný place in which an offence relating to manufacture, sale or
an Indian University.

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distribution of drugs or cosmetics has been or is being committed;
For inspection of the manufacture of substances in Schedule C the
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3. Stop and search any vehicle, vessel or other conveyance being

used
persons appointed as Drugs Inspectors must have (i) at least 18 months for carrying any drug or cosmetic in respect of which an offence

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experience in the manufacture of at least one of the substances specified has been or is being committed and order in writing the person in
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in Schedule C; or (i) at least 18 months' experience in testing of at least possession of such drug or cosmetic not to dispoé off any stock
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one of the substances in Schedule C in an approved testing laboratory; or that of for a specified period not exceeding 20 days, or unless the
(i) gained experience of not less than 3 years in the inspection of firms alleged offence is such that defect may be removed by possessor of
manufacturing any of the substances in Schedule C during the tenure of drug or cosmetic, seize stock of such drug or Cosmetic and any
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their services as Drugs Inspectors. substance or article by means of which offence has been or is
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All Inspectors appointed by the Central or State Government shall be being committed or which may be employed for commission of
under the respective controlling authority. such offence;
For the purposes of inspecting shops in any specified area any officer of 4. Examine any record, register, document or any other material
the medical or public health department who is a Registered Medical object with any person or in any place mentioned above and seize
Practitioner/a graduate in science may be appointed ex-officio inspector. the same if it is likely to furnish evidence of an offence;
For the purpose of inspection of manufacture of veterinary biological 5. Require any person to produce any record, register or
other
products the person appointed as Drugs Inspector should be (i) a graduate document relating to manufacture, sale or distribution of any drug
in veterinary science/medical science/general science/pharmacy and have at or cosmetic in respect of which an offence has been or is being
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least 18 months experience in the manufacture and testing of biological committed;
products. Provided that Drugs Inspectors who have gained experience of at 6. Exercise such other powers as may be necessary for carying out
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least 3 years in the inspection of firms manufacturing any of the drugs the purposes of the Act or the Rules.
specified in Schedule C, shall be authorized to inspect the manufacture of
Procedure of inspectors An inspector taking any samples should pay
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veterinary biological products. its fair price and take a written acknowledgement for the same.
If the
price tendered is refused or where the Inspector seizes
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Powers of inspectors the stock of any
drug or cosmetic, he should issue a receipt for the same in
of premises where any drug or cosmetic is being
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A. 1. Inspection the prescribed

manufactured and the means employed for standardizing and test form. He should also inform purpose of taking sample to concerned
person
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ing the drug or cosmetic; unless he willfully absents himself, and divide the sample into
4 parts in
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his presence. Each portion is then sealed effectively and suitably

2. Inspection of premises where any drug or cosmetic is being sold, marked.
The person from whom the sample is taken should
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or stocked or exhibited or offered for sale or distributed. be prmitted to add his
own seal and mark to all or any of the portions sealed or
marked. One
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B. 1. Taking samples of any drug or cosmetic which is being manufac- portion of the sample should be restored to the person from whom
tured or being sold or is stocked or exhibited or offered for sale or it was
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taken, the second portion is sent to the Government Analyst for
is being distributed; test or
analysis, the third one is preserved for production before
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the çout if;

2. Taking samples of. drug or cosmetic from any person conveying, required, and the fourth portion is sent to the warrantor, if any.
delivering or prepaing to deliver such drug or cosmetic to a Any seizyre or search should be made in accordance
purchaser or a consignee. with the provisions
of Code of Criminal Procedure 1898.
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Telegram - Study Pharmacy PHARMACEUTICAL JURISPRUDENCE Ch-4 DRUGS AND COSMETICS ACT AND RULES 75

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14
by Inspector should be Note: Preparations containing above substances excluding those in-
Any record, register or other document seized tended for topicat or external use are also covered by this schedule.

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produce the same
returned to persons from whom-they were seized or who
within, a period of 20 days of uch seized or produce, as the case may be,
person, in. such SCHEDULE H
after copies thereof or extracts therefrom certified by that

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prescribed, have been taken. (Prescription Drugs)
manner as may be

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or any other Acebutol HCL, Aclarubicin inj., Actilyse, Acylovir, ACTH, Alclometasone
When an Inspector seizes any record, register, document
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material object he should, as soon as may be, inform Judicial

a Magistrate dipropionate, Allopurinol, Alphachymotrypsin, Alprazolam, Amantadine HCl,
and take his orders to the custody thereof. Amikacin, Amineptine, Amiloride HCl, Aminoglutethimide tab., Aminosali-

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any drug cylic acid, Amiodarone HCL, Amitryptiline, its salts; Amoscanate, Amoxapine,
Every person for time being in charge of any premises where
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or is kept for sale or distribution, on Amrinone lactate, Analgin; Androgenic, anabolic, oestrogenic and progesta-
or cosmetic is being manufactured
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do so, is legally bound to disclose to the tional substances; Antibiotics, Aprotinin, Organic compound of arsenic for
being required by an Inspector to
manufactured or is injection, Articaine HCL, Astemizole, Atenolol, Atracurium besylate inj..
Inspector the place where the drug or cosmetic is being Auranofin, Azathioprine; Barbituric acid, its salts, derivatives of barbituric
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kept. acid, their salts; Becampicilin, Benserazidè HCL, Betahistine dihydrochloride,
Willfuly obstructing an Inspector in the exercise of powers, or
refusing
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HCL, Bitoscanate,
Bethanidine sulphate, Bezafibrate, Biclotymol, Biperidn
any record, register or other document by any person is Bromhexine HCL, Bromocryptine mesylate,
produce Bleomycin oil suspension,
fine, or with both.
punishable with imprisonment upto three years, or with Budesonide, Bupivacaine HCl, Buspirone, Captopril, Carbidopa, Carbocistine,
Carboplatin inj., Carboquone, Carisoprodol, L. carnitine, Cefadroxyl,
APPENDIX Cefatoxime sodium, Ceftazimide pentahydrate, eftizoxime sodium sterile,
SCHEDULE G Cefuroxime, Cefuroxime axetil, Centbutindole, Centchroman, Ciclopirox
olamine, Clindamycin, Cimetidine, Cinnarizine, Ciprofloxacin HCl monohy-
[List of substances to be used only under medical
supervision and to be
drate/lactate; Chlordiazepoxide, its salts; Chlormezanone, Chlorpromazine,
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labeled accordingly] its salts; Chlorzoxazone, Clavulanic acid, Clinidium Br, Clobetasol propion-
Carbutamide,
Aminopterin, L-Asparaginase, Bleomycin, Busulphan its salts, ate, Clobetasone 17-butyrate, Clofazimine, Clofibrate, Clonidine HCl,
of 1,2,4 Clopamide. Clostebol acetate, Clotrimazole; Codeine, its salts and deriva-
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Chlorambucil its salts, Chlorothiazide and other derivatives
Chlorthalidone and other deriva- tives; Colchicine; Corticosteroids, their esters, their derivatives and their
benzothiaurazine, Chlorpropamide its salts,
Chlorobenzene compound, Cis-platin, Cyclophosphamide its salts, dosage forms; Cotrimoxazole, Cyclandelate, Cyclosporin oral suspension,
tives of
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Disodium Stilbosteol Danazol; Dapsone, its salts and' derivatives; Desogestrol, Dextranomer;
Cytarabine, Daunorubicin, Di-Isopropyl Fluorophosphate,
salts, Etho- Dextropropoxyphene, its salts; Diazepam, Diazoxide, Diclofenac sodium,
Di-phosphate, Doxorubicin Hydrochloride, Ethacrynic Acid, its
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Ph
Glibenclamide, Hydiantion, its salts; its derivatives, and their Digoxine, Dilazep Hc, Dinoprostone; Diphenoxylate, its salts; Disopyramide,
ha

suximide, Mannomustine;
salts, Hydroxyurea, Insulin, all types; Lomustine Hydrochloride Domperidone, Dopamoine HCL, Dothieptin HCl, Doxsapram HCL, Econazole,
ar

ar

ar
Metformin; its salts, Methsuximide, Enalapril maleate, Enfenamic acid; Epinephrine, its salts; Epirubicine inj.,
its salis, Mercaplopurine; its salts, Phenformin; its salts, 5- Ergot alkaloids, Estradiol succinate, Estramustine phosphate capsule,
rm

Mustine; its salts, Paramethadione, Phenacemide,

Primidone,
Phenylhydantoin; its alkyl and arylderivatives; its salts, Ethacridine lactate, Ethambutol HCL Ethamsylate, Ethinooestradiol, Ethiona-
ma

ma

ma
Hydrochloride, Quinthazone Sacrolysine, Sodium 2-mercapto- mide, Etomidate, Etoposide cap.. & inj., Famotidien, Flavoxate HC; Flufenamic
Procarbazine
ac

Tolbutamide, Tretamine; acid, its salts, its esters, their salts; Flunarizine HCl, Flupenthixol, Flu-
sulfonate, Taxmxifen Citrate, Testolactone, Thiotepa,
An ihistaminic substances, the following, their salts, phenazine enanthate and decanoate, Flurazepam, Flurbiprofen, Flutamide,
cy

cy

cy
its salts, Troxidone,
Antazoline, Bromodiphen- Fp10xetine HCL, Galanthamine HBr; Gallamine, its salts. its quarternary
y

their derivatives, salts of their derivatives; Clemizole,

hydramine, Buclizine, Chlorcyclizine, Chlorpheniramine, Cömpound; Gemfibrozil, Genodeoxycholic acid, Gliclazide, Glucagon,
Succinate, Glycopyrrolate, Glydiazinamide, Guanethidine, Gugulipid, Halogenated
Cyproheptadine Diphenhydramine, Diphenylpyraline, Doxylamine
Napadisylate, Meclozine, Phenindamine, hydroxyquinolines, Haloperidol, Heparin, Hepatitis B. vaccine, Hyaluroni-
Isothipendyl, Mebhydroline
being tetra-
Pheniramine, Promethazine, Thenalidine, Tripolidine, Substance dase, Hydrocortisone 17-butyrate, Hydrotalcite; Hydroxyzine, its salts;
N-substituted derivatives of Ethylene Diamine or propylendiamine.
St

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ud

ud

u
y

y
Ph

Ph

Ph
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Insta - Study_Pharmacy_29
Telegram - Study Pharmacy
76 PHARMACEUTICAL JURISPRUDENCE
Ch-4 DRUGS AND COSMETICS ACT AND RULES 11
SCHEDULE H1 DRUGS

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Ibuprofen; Imipramine, its salts; lindapamide; Indomethacin, its salts; A. 3rd, 4th generationantibiotics and Carbapenum groups of drugs.

ud

ud

ud

u
Insulin human, Interferon alpha inj., Intralipid, Iohexol sterile solution, Meropenem, Imipenem, Ertapenem, Doripenem, Feropenem, Balofloxacin,
Iopamidol sterile solution, Iopromide, Iron preparations for parenteral use, Cefdinir, Cefditoren, Cefepime, Cefetamet, Cefixime, Cefoperazone,
Isocarbozazid, Isoflurane; Isonicotinic acid hydrazide & other hydrazine Cefotaxime, Cefpirome, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime,

y
derivatives of isonicotinic acid, their derivatives, their salts; Isosorbide Ceftriaxone, Gemifloxacin, Levofloxacin, Moxifloxacin, Prulifloxacin.
mononitrate, dinitrate; Isoxpurine, Ketamine HCl, Ketoconazole acetate,

Ph

Ph

Ph
Sparfloxacin
Ketoprofen, Labetalol HCl; Levarterenol, its salts; Levodopa, Lidoflazine,
ha

B. List of the Habit forming Drugs.

Lithium carbonate, Lofepramine decanoate, Loperamide, Lorazepam, Loxapine
Alprazolam, Buprenorphine, Chlordiazepoxide,

ar

ar

ar
Codeine,
Mebendazole, Mebeverine HCl, Medroxy progesterone acetate tablets;
Dextroropoxyphene, Diazepam, Diphenoxylate, Midazolam/ Nitrazepam, Pen-
Mefenamic acid, its salts, its esters, their salts; Megestrol acetate, Meglumine
r

locarmate, Melagenina lotion; Mephensin, its esters; Mephentermine, tazocine, Propoxyphene, Tramadol, Zolpidem
ma

ma

ma

ma
Mesterolonje, Methicillin Na, Methocarbamol, Metoclopramide, Metoprolol C. List of the Anti-TB Drugs
tartarate, Metrizamide, Metronidazole, Mexilentine HCl Mianserin HCl, Ethambutol Hydrochloride, Isoniazid, Pyrazinamide, ifampicin, Ethiona-
Miconazole, Minocycline, Minoxidil, Mitroxantrone HCL Mometasone furoate,
c

c
mide, Cycloserine, Sodium Para-aminosalicylate, Rifabutin, Capreomycin,
Morphazinamide HCl, Narcotic drugs under relevànt Act, Nadolol, Nalidixic
y

y
Clofazimine, Thiacetazon
acid, Naproxen, Natamycin, Metilmicin S04, Nicergoline, Nifedipine,
Nimustine HCl, Nitrazepam, Nitroglycerin inj., Norethisterone enanthate
inj., Norfloxacin, Ofloxacin; Orphendadrine, its salts; Orthoclone sterile,
SCHEDULE J
Oxazepam; Oxazolidine, its salts; Oxethazine HCL Oxolinic acid, Oxprenolol Diseases and ailments (by whatever name described) which a drug may
HCl, Oxyfedrine, Oxymetazoline, Oxyphenbutazone, Oxytocin, Ozothine, not purport to prevent or cure.
Pancuronium Br., Ara amino benezene sulphonamide, its salts and deriva- Aids, Angina pectoris, Appendicitis, Arteriosclerosis, Baldness, Blind-
tives: PAS, its salts, its derivatives; D-penicilamine, Pentazocine, ness, Bronchial asthma, Cancer and benign tumour, Cataract, Change in
Pentuxifylline, Pepleomycin inj., Phenelzine, its salts; Phenothiazine, de-
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colour of the hair and growth of new hair, Change of foetal sex by drugs,
rivatives of and salts of its derivatives; Phenobarbital; Phenylbutazine, its Form and structure of breast, Improvement in size and shape of the sexual
salts; Pimozide, Pindolol, Piracetam, Piroxicam; Pituitary gland, the active organ and in duration of sexual performance, Maintenance or improvement
ud

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u
principles of, not otherwise specified in this schedule and their salts; of the capacity of the human being for sexual pleasure, Sexual impotence,
Polidocanol inj., Polyestradiol phosphate inj., Praziquantel, Prednimustine premature ejaculation and spermatorrhoea; Congenital malformations, Deaf
tablets, Prednisolne stearoglycolate, Prenoxadiazin HCL, Promazine HCl,
y

y
ness, Diabetes, Diseases and disorders of uterus, Epileptic fits and psychiatric
Propafenon HCL Propranolol HCL, Protristylkine HCl, Pyrazinamide; Pyrvinium, disorders, En cephalitis, Fairness of the skin, Gangrene, Genetic disorders,
Ph

Ph

Ph
its salts; Quinidine sulphate, Ranitidine, Rauwolfia alkaloids, Reproterol Glaucoma, Goitre, Hernia, High/low blood pressure, Hydrocele, Insanity.
ha

HCL, Rosoxacin, Salbutamol So4, Salicylazosulphapyridine, Satranidazole, Increase in brain capacity and improvement of memory, Improvement in
Septopal beads and chains, Seratio peptidase, Sisomicin S04, Sodium height of children/adults, Improvement in the strength of natural teeth,
ar

ar

ar
chromoglycate, Sodium hyaluronate solution, Sodium and meglumine Improvement in vision, Jaundice/hepatitis/liver disorders, Leukaemia, Leu-
rm

iothalamates, Sodium valproate, Sotalol, Spectinomycin HCL Spironolac- coderma, Mental retardation, subnormality and growth; Obesity, Paralysis,
ma

ma

ma
tone, Sucrafate, Sulphadoxine, Sulphamethoxine, Sulphamethoxypyridazine, Parkinsonism, Piles and fistulae, Power to rejuvenate, Premature ageing,
Sulphaphenazole, Sulprostone inj., Teratolol HC, Terbutaline S04, Premature greying of hair, Rheumatic heart diseases, Spondylitis, Stammer
ac

Terfenadine, Terizidone, Testosterone undecoanoate, Tiaprofenic acid, Timolol ing, Stones in gall-bladder, kidney, bladder; Varicose vein
cy

cy

cy
maleate, Tinazoline, Tinidazole, Thiacetazone; Thiopropazate, its salts;
y

Trazodome Tre,inoin, Trifluperazine, Trifluperidol HCL, Trimetazidine

dihydrochloride, Trimipramine,: Tripotassium dicitrate bismuthate, Uroki-
nase, Vasopressin, Vecuronium Br. inj., Verapamil HCL, Xipamide, Zidovudine
cap.
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y

y
Ph

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Ph
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Insta - Study_Pharmacy_29
Telegram78 - Study Pharmacy PHARMACEUTICAL JURISPRUDENCE Ch-4 DRUGS AND COSMETICS ACT AND RULES 79

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SCHEDULE P
(Life period of drugs)

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28. Cloxacillin (0ral) s6 In a cool place
S.No Name of the drug Period in months Conditions of storage 29. Cloxacillin Sodium (Injection Grade) S6 In a cool place
1 2 3 4 30. Colistin Sulphate 60 Protected from light

y
31. D-Cycloserine 48 In a cool place
Antibiotics

Ph

Ph

Ph
32. Dimethyl Chlortetracycline 48
1. Adramycin 30 In a cool place
Hydrochloride
ha

2. Ampicillin 36 In a cool place

33. Dimethyl Chlortetracycline 36

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ar

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3. Ampicilin Capsules 24 Hydrochloride Capsules
r

4. Ampicillin Dry Syrup 24 34. Daunoblastin Injection 36

ma

ma

ma

ma
5. Ampicillin Injection 24 35. Doxycycline Hydrochloride 48 In a cool place
6. Ampicilin Sodiumn 36 In a cool place 36. Doxycycline Monohydrate 36 In a cool place
7. Ampicilin Trihydrate 30 In a cool place 37. Doxycycline Monohydrate 24
c

c
8. Amoxyciline Trihydrate 36 In a cool place for Oral Suspension
y

y
9. Amoxycilline Trihydrate Capsules 24 38. Doxycycline Monohydrate Capsules 36
10. Amoxyciline Trihydrate Dry Syrup 18 39. Erythromycin Estolate 36 in a cool place

11. Bacitracin 18 In a cool place 40. Erythromycin Ethylsuccinate 60 In a cool place

12. Bacitracin or Zinc Bacitracin Tablets 12 41. Erythromycin Oral Suspension 36
13. Bacitracin Lozenges 12 42. Erythromycin Estolate 36
14. Carbenicillin Sodium Injection 24 At temperatures not for Oral Suspension
exceeding 5°C. 43. Erythromycin Ethy Succinate Tablet 24
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15. Carbanicillin Sodium Powder 24 -do- 44. Erythromycin Estotate Tablets 24
16. Cephalexin 24 In a cool place 45. Erythromycin Stearate 36 In a cool place
In a cool place In a well closed con-
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17. Chloramphenical 60 46. Framycetin Sulphate 48
48 tainer with temperature
18. Chloramphenicol Capsules not exceeding 30°C.
and Tablets
y

y
48 47. Framycetin Sulphate Eye Drops 24 -do-
19. Chloramphenicol Palmitate
48. Framycetin Sulphate Ointment 24 -do-
Ph

Ph

Ph
20. Chloramphenicol Palmitate 36
Oral suspension 49. Gentamycin Sulphate 60 In a cool place
ha

21. Chloramphenicol Eye Drops 24 50. Gentamycin Sulphate Injection 36

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22. Chloramphenicol Sodium 48 In a cool place 51. Gramicidin 60 In a cool place
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Succinate Powder 52. Griseofulvin 48 In a cool place

In a cool place
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23. Chloramphenicol Sodium 36 53. Griseofulvin Tablets 36
Succinate Injection 54. Kanamycin Sulphate Injection 24
ac

24. Chlortetracycline Hydrochloride 50 In a cool place Kanamycin Acid Sulphate Powder 48 In a cool place
55.
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cy

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25. Chlortetracyctine Hydrochloride Caps. 60 56. Mitomycin C 48 In a cool place
y

26. Chlortetracyctine Hydrochloride 24 57. Neomyein S; lphate 48 In a cool place

Tablets 58. Mystatin 36 At temperature not
27. Chlortetracycline Hydrochloride 24 exceeding 5°C
Ointment
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Insta - Study_Pharmacy_29
Telegram - Study
80 Pharmacy PHARMACEUTICAL JURISPRUDENCE
Ch-4 DRUGS AND COSMETICS ACT AND RULES 81

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1 3
24 In a cool place In a well-closed con

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59. 0teandomycin Phosphate sterile 4. Thiamine Dihydrochloride 48
60. Oleandomycin Phosphate pon sterile 36 In a cool place tainer, protected from
61. Oxytetracyctine Hydrochloride 36 In a cool place light, in a cool place.

y
62. Oxytetracycline Hydrochloride 36 5. Thiamine Mononitrate 48 -do-
Riboflavin 60 -do-

Ph

Ph

Ph
Capsules 6.
63. Oxytetracycline Hydrochloride Tablets 24 7. Riboflavin 5-Phosphate 24 -do-
ha

64. Oxytetracyeline Hydrochloride 24 8. Riboflavin Tablets 36

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Injection 9. Vitamin B2 Injection 24
r

65. Oxytetracycline Hydrochloride 36 10. Vitamin B6 60 In a well-closed con-

ma

ma

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ma
Ointment tainer, protected from
66. Penicillin Crystalline 36 In a cool place light, in a cool place.
67. Penicillin Tablets 18 -do- 11. Vitamin B6 tablets 36
c

c
68. Procaine Penicillin 6 36 -do- 12. Cyanocobalamin 48 In a well-closed con
y

y
69. Benzathin Penicilline G 48 -do- tainer, protected from
70. Potassium Phenoxy Methyl Penicillin 48 -do- light, in a cool place.
24 13. Hydroxycobalamin 48 -do
71. Potassium Phenoxy Methyl
Penicilin Tablets 14. Vitamin B12 Injection 36
72. Polymixin B Sulphate 48 In a cool place 15. Calcium Panothenate 36 In a well-dosed con-
Polymixin B Sulphate 24 -do- tainer, protected from
73.
Ointment or Powder
light, in a cool place.
Rifampicin 36 In a cool place 16. Vitamin C Injection 24 .
74.
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36 17. Calcium Pantothenate Tablets 36
75. Rifampicin Capsules
24 In a cool place 18. Vitamin C 48 In a well-closed con-
76. Spiramycin Base
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tainer, protected from
77. Streptomycin Injection 36
light, in a cool place.
78. Streptomycin Ointment 24 19. Vitamin D2 D3 36 -do
y

y
79. Streptomycin Tablets 24 Vitamin E or E-Acetate
20. 60 -do-
80. Streptomycin Sulphate 48 Attemperature
Ph

Ph

Ph
21. Folic Acid 60 -do-
not exceeding 20°C
ha

22. Folic Acid Tablets 36

81. Tetracycline Base 24 In a cool place
23. Vitamin K 60 In a well-closed con-
ar

ar

ar
82. Tetracycline Hydrochloride 36 In a cool place
tainer, protected from
rm

83. Tetracycline Hydrochloride Capsules 36 light, in a cool place.

ma

ma

ma
84. Tetracycline Tablets 24 24. Vitamin K Injection 36
85. Tyrothricin 60 In a cool place 25. Niacinamide 60 In a well-closed con
ac

Vitamins tainer, protected from

cy

cy

cy
light, in a cool place.
1. Vitamin Iniection
A 24
y

26. Niacinamide Tablets 36

2. Vitani: lajection
B1 24
27. D-Panthenol In a well-cdosed con-
Thiamine Mononitrate TTablets
50
3. 36
tainer, protected from
a
light,in cool place.
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Insta - Study_Pharmacy_29 .

Telegram -82Study Pharmacy PHARMACEUTICAL JURISPRUDENCE Ch-4 DRUGS AND COSMETICS ACT AND RULES 83

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1 4

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10. Cobra Venom in Solution Between 2°C and 5°C
Insulin Preparationss protected from light.
At temperature between
1. Globuline Zinc Insulin Injection 24
Diphtheria Toxoid 24 In cold place.
2°C and 8°C, must not 11.

y
be allowed to freeze. 12. Inactivated Diagnostic 12 In cold place.

Ph

Ph

Ph
24 -do- Diphtheria Toxin
2. Insulin Injection
ha

13. Liquid Serum 12 Between 2°C and 10°C

Insulin Zinc Suspension 24 -do-
3. preferably at the lower limit.

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Insphane Insulin Injection 24 -do-
4. 14. Lyophilised Anti-snake Venom Serum 60
r

Normal Human Plasma 15. Lyophilised Schick Test 60

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ma

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ma
Globulin 12 In a cool place. Toxin and Control
1. Anti-Haemophillic Human
60 At temperature not 16. 0ld Tuberculin 60 In cold place.
2. Dried Plasma
exceeding, 25°C. 36. In cold place.
17. Thrombin (Bovine Origin)
c

c
3. Dried Normal Human 60 At temperature not 18. Tetanus Toxoid 36 In cold place.
y

y
exceeding 25°C.
Serum Albumin 19. Tuberculin PPD 60 In cold place.
50 In deep freeze.
4. Frezen Plasma
24 In cold place. Other Vaccines
5. Liquid Plasma
In cold place. 1. Alum Precipitated Pertussis Vaccine 18 In cold place.
6. Liouid Normal Human Serum Albumin 60
At temperature between 2. BCG Vaccine 24 days In cold place.
7. Wi1ole Human Blood 21 days
4°C and 6°C. 3. Cholera Vaccine 8 In cold place.
4. DHL Vaccine (for dog) 12 In cold place.
Sera, Toxin and Toxoid 5. Measles Vaccine 24 In cold place.
In cold place.
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1. /lum Precipitated Diphtheria
Toxoid 24
6. Hague Vaccine 6 In cold place.
18 In cold place.
2. lum precipitated Diptheria and 7. Polio Vaccine 24 When stored at -20°C.
ud

ud

ud

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Tetanus Toxoid and Pertusis When stored at 0°C
vaccine combined
24 In cold place. 3 When stored at 4°C.
3. Alum Precipitated Tetanus
Toxoid
y

y
24 In cold place. 8. Rabies Vaccine In cold place.
4. Aluminium Hydroxide Absorbed
9. Typhoid Vaccine 18 In cold place.
Ph

Ph

Ph
Diphtheria Toxoid
Aluminium Hydroxide Absorbed 18 In cold place. 10. Typhoid and Para Typhoid Vaccine 18 In cold place.
ha

5.
Diphtheria Tetanus Toxoid and 11. Typhoid Para Typhoid A 18 In cold place.
ar

ar

ar
Pertussis Vaccine combined and BVaccine
In cold place.
rm

Aluminium Phosphate Absorbed 24 12 Typhoid Para Typhoid A, In cold place.

6 l8
Diphtheria Toxoid B &C Vaccine
ma

ma

ma
Aluminium Phosphate Absorbed 24 In cold place. 13. Typhoid Para Typhoid A, 18 In cold place.
ac

Diphtheria and Tetanus Toxoid B & C

and Tetanus Vaccine
. In cold place.
cy

cy

cy
Aluminium Phosphäte Absorbed 18 14. Typhus Vaccine 12 In cold place.
Diphtheria Toxoid Tetanus Toxoid
y

15. Yellow Fevgr inccin 12 In cold place.

and Pertussis vaccine combined 16. Anti-Rabies Vaccine (Cell Culture) 24 In cold place.
12 In cold place.
9. Diagnostic Diphtheria Toxin (Schick Test)
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St

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St
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y

y
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Insta - Study_Pharmacy_29
Telegram - Study
84 Pharmacy PHARMACEUTICAL JURISPRUDENCE Ch-4 DRUGS AND COSMETICS ACT AND RULES
85

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SCHEDULE P-1
(Pack Sizes of Drugs)

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Antitoxin Name of the Drug Dosage fom Pack size
(For serum extracted preparationis)
Albendazole

y
20 % Excess potency 12 In cold place. Suspension 10ml
30 % Excess potency 24 In cold place. Atenolol
Tablets 14

Ph

Ph

Ph
40 % Excess potency 36 In cold place. Anti-Haemmorhoidal Topicals Rectal Capsules
ha

20
50 % Excess potency 48 In cold place. Aspirin (Low-dose) Tablets 14

ar

ar

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(for enzyme preparations) Cholecalciferol or Ergocalciferol Granules 1 gm. Sachet
r

5 % Excess potency 12 In cold place. Ciclopiroxolamine Vaginal Cream 30 gms

ma

ma

ma

ma
10 % Excess potencyy 24 In cold place. Catalin
In cold place. Ophthalmic drops 15 ml
15 % Excess potency 36
Famotidine Tablets
20 % Excess potency 48 In cold place. 14
c

c
Glyceryl Trinitrate (Long Acting) Spansules
Miscellaneous Drugs 25
y

y
Isosorbide Dinitrate (Long Acting) Spansules
1. Adrenaline for Injection 12 In cold place.
Isoniazide
25
2. Chorionic Gonadotraphin 36 At temperature not Syrup 200 ml
for injection (Lyophoised) exceeding 20°C. Ipecacuanha Syrup ml
3. Corticotrophin 24 In cold place. Oral Rehydration Salt (ORS) Powder Pouches to be
4. Corticotrophin Lyophitised 36 In cold place. reconstituted to one litre
In a cool place. in one pack or in 5 unit
5. Heparin Injection 36
dose sachets in one pack
6. Liquid Extract or Egot 12 In cold place.
Piperazine
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7. Liver Extract Crude Injection 24 In a cool place. Granules 5 gm
Syrup
8. Oxytocin Injection 24 In cold place. 30 ml
Pyrantel Pamoate
ud

ud

ud

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9. Paraldehyde Injection 6 In cold place protected Syrup 8 ml or 10 ml
from light. Potassium Chloride Syrup 60 ml and 200 ml
10. Pituitary Injection 24 In cold place. Progestogen Qestrogen (Combi- Tablets
y

y
21 or 22 with or
11. Vasopressin Injection 24 In cold place. nations for Oral Contraception)
without placebo
Ph

Ph

Ph
Roxatidine Acetate Hydrochloride
Note: Tablets 14
ha

Vitamin A Oral Drops

1. "Cool place" means place having a temperature between 10°C and 25°C. Drops 7.5 ml
Co-trimoxazole Suspension
ar

ar

ar
2. "Cold place" means a place having a temperature not exceeding 8°C. 50 ml
Haloperidol Oral Solution 15ml
rm

3. Capsules should be kept in a well-closed container at temperature not exceeding Loxapine Oral Liquid Concentrate 15 ml
ma

ma

ma
30°C.
4. Wherever condition of storage is not specified in column 4, may be stored
ac

under normal room temperature. SCHEDULE W

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Names of drugs which shall be marketed under generic
names only]
.
y

Analgin, Aspirin and its salts, Chlorpromazine and

sulphate, Piperazine and its salts.
its salts, Ferrous
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y

y
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Insta - Study_Pharmacy_29
Telegram - Study Pharmacy
86
PHARMACEUTICAL JURISPRUDENCE

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SCHEDULE X
Amobarbital, Amphetamine, Barbital, Cyclobarbital, Dexamphetamine,

ud

ud

ud

u
Ethchlorvynol, Glutethimide, Meprobamate, Methamphetamine, Methaqualone,
Methylphenidate Methylphenobarbital, Pentobarbital, Phencylidine, Phenm- 151

y
etrazine, Phenobarbital, Secobarbital.

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Drugs and Magic Remedies
ha

(Objectionable Advertisements) Act

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rma

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ma

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Introduction Advertisements have become a part of our life and
advertising has undergone revolutionary changes due to explosion in
c

c
communication technology. Modern methods of advertising like televi-
y

y
sion, internet, cell phones (mobiles) etc have proved to be very effective.
Manufacturers of drugs and cosmetics are blamed for spending exorbitantly
on advertising their products but this has become necessary in view of the
competition in the market. Advertisements for drugs are not meant for the
public directly but through qualified persons like physicians, pharmacists
and nurses etc. However advertisements for 0TC (over-the-counter) drug
products and cosmetics are meant for general public. One additional
problem in India is related to the advertisements of magic remedies.
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People selling magic remedies tike kavachas, mantras, talismans etc. are
common in streets in Indian cities. These people claim that the magic
remedies sold by them can cure any and every disease on earth.
ud

ud

ud

u
In recent years there has been a great increase in the number of
objectionable advertisements published in newspapers and magazines etc
y

y
relating to alleged cures for venereal diseases, sexual stimulants and about
diseases and conditions peculiar to women. These advertisements tend to
Ph

Ph

Ph
cause the ignorant and the unwary to resort to self-medication with
ha

harmful drugs and appliances, or to resort to quacks who indulge in such

ar

ar

ar
advertisements for treatments which cause great harm to the health of
rm

individuals. It was necessary in the public interest to put a stop to such

ma

ma

ma
undesirable and harmful advertisements.
Drugs and Magic Remedies (Ohjectionable Advertisements) Act, 1954
ac

was passed with the objective of controlling the advertisements of drugs in

cy

cy

cy
certain cases, to prohibit the advertisement for certain purposes for
y

remedies alleged to possess magic qualities and to provide for related

matters. The scope artd öbject of the Act is to prevent self-medication or
self-treatment and for that purpose advertisements commending certain
drugs and medicines have been prohibited.
87
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Insta - Study_Pharmacy_29
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88 PHARMACEUTICAL JURISPRUDENCE Ch-5 DRUGS AND MAGIC REMEDIES (OBJECTIONABLE ADVERTISEMENTS)
ACT 89

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The Drugs and Magic Remedies Act was passed on 1st April, 1955 and (a) directly gives a false impression regarding the true character of the
extends to the whole of India except the State of Jammu and Kashmir. drug; or

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(6) makes a false claim for the drug; or
Definitions i () is otherwise false or misleading in any material particular.
Advertisement includes any notice, circular, label wrapper, or other

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document, and any announcement made oraly or by means of produc- 3. No person carrying on or purporting to carry on the profession of
advertising magic remedies should take part in the publication of any

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ing or transmitting light, sound or smoke.
advertisement referring to any magic remedy which directly or indirectly
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Drug includes (a) medicines for the internal or external use of human claims to be efficacious for any of the purposes specifed at (1)
beings or animals; (6) any substance intended to be used for or in the above.

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diagnosis, cure, mitigation, treatment or prevention of disease in 4. No person shall take part in the publication of any advertisement
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human beings or an imals; (c) any article, other than food, intended to refering to any drug in terms which suggest or are calçulated to lead to
the use of that drug for diagnosis, cure, mitigation, treatment or preven-
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affect or influence in any way the structure or any organic function of
the body of human beings; (d) any article intended for use as a tion of any disease, disorder or condition in Asthma and AIDS.
Component of any medicine, substance or article' referred to in (a), (6) Import and export of all the above mentioned advertisements is
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and (c) above. prohibited.
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Magic remedy includes a talisman, mantra, kavacha and any other charm
of any kind which is aleged to possess miraculous powers for or in the Exempted Advertisements i
diagnosis, cure, mitigation, treatment or prevention of any disease in Advertisements are permitted (not prohibited) if made in the manner
human beings or animals or for affecting or influencing in any way the mentioned below:
structure or any organic function of the body of human beings or (a) Any sign board or notice displayed by a RMP on his premises
animals. indicating that the treatment for any disease, disorder or condition
Taking part in the publication of any advertisement includes (a) the is undertaken relating to which advertisements are otherwise pro0-
printing of the advertisement; and (6) the publication of any advertise- hibited; or
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ment outside the territories: to which this Act extends by or at the (6) Any treatise or book dealing with any of the matters relating
to
instance of a person residing within the said teritories. the diseases or conditions which are otherwise prohibited to be
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advertised, provided they are published from a bona fide scientific
Prohibited Advertisements i or social standing; or
No person can take part in the publication of any advertisement
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1. ()Any advertisement relating .to any drug sent confidentially to a
referring to any drug in terms which suggest or are calculated to lead to RMP; or
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use of that drug for:
()Any advertisement relating to a drug printed or published by thee
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() procurement of miscariage in woman, or prevention of conception Government, or by any person with the prior permission of the
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in woman; or Government.
(6) maintenance or improvement of capacity of human beings for
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In public interest, the Central Government may permit the

sexual pleasure; or adver-
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tisement of any specified drug or classes of drugs which may be
(c) correction of menstrual disorder in woman; or otherwise prohibited under the Act.
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(a) diagnosis, cure, mitigation, treatment or prevention of any disease (e) Any advertisement, labels or sets of instructions which are permit-
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disorder or condition specified in ScheduleJ of the Drugs and ted under the Drugs and Cosmetics Act or Rules.
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Cosmetics Ruile, 19;5.

2. No person shall take part in the publication of any advertisement
relating to a drug if the advertisement contains any matter which:
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Insta - Study_Pharmacy_29 .
Telegram - Study Pharmacy
90
PHARMACEUTICAL JURISPRUDENCE Ch-5 DRUGS AND MAGIC REMEDIES (08JECTIONABLE ADVERTISEMENTS) ACT 91

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exempted conditionally as Class of Advertisement Conditions
The following classes of advertisements are
shown in the Table.

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Or
Conditions () Centchroman-30 mg.
Class of Advertisement
2. The advertiser is responsibile to prove
advertisement contains only such

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1. The
1. Leaflets or literature accompany- that any claim made in the advertise-
information as is required for the guid-
ing packing of drugs; and ment in respect ot the drug is not false,

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ance of RMP in respect of matters exaggerated or misleading.
2. Advertisements of drugs in medi-
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relating to
cal, pharmaceutical, scientific and drug:
(a) therapeutic indications of the

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technical journals.
(b) its administration; Diseases Which Can't be Claimed to be Cured
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(c) its dosage; Diseases and ailments (hy whatever name described) which a drug may
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(d) its side effects; and not purport to prevent or cure. [Schedule J - Drugs & Cosmetics Act]
(e)the precautions to be observed in AIDS, Appendicitis, Arteriosclerosis, Asthma, Blindness, Blood poison
the treatment with the drug. ing, Bright's disease, Cancer, Cataract, Deafness, Diabetes, Diseases and
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2. The advertiser is responsibile to prove disorders of brain, optical system and uterus; Disorders of menstrual flow,
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that any claim made in the advertise nervous system and prostatic gland; Dropsy, Epilepsy, Female diseases (in
ment in respect of the drug is not false, general), Fevers (in general). Fits, Form and structure of female bust: Gall
exaggerated or misleading. stones, kidney stones and bladder stones; Gangrene, Glaucoma, Goitre,
1. The advertisement contains
only such
Heart diseases, High or low blood pressure, Hydrocele, Hysteria, Infantile
3. Price lists or therapeutic indexes information as is required for
published by manufacturers, im- technical paralysis, Insanity, Leprosy, Leucoderma, Lockjaw, Locomotor ataxia, Lupus,
porters or distributors of drugs the guidance of RMPs in regard to thera- Nervous debility. Obesity, Paralysis, Plague, Pleurisy, Pneumonia, Rheuma-
peutic indications of drugs, the manner tism, Ruptures, Sexual impotence, Smallpox, Stature of persons, Sterility in
duly licensed under the Drugs
of their administration, their dosage,
and Cosmetics Act, 1940 and the to be women, Trachoma, Tuberculosis, Typhoid fever, Ulcers of gastrointestinal
side effects and the precautions
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Rules ereunder; and
observed in the treatment.
tract. Venereal diseases including syphilis, gonorhoea, soft chancre,
4. Medical literature distributed
by venereal granuloma and lympho granuloma.
distribution of such literature is
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medical retailers appointed by. 2. The only to the RMPs, hospitals,
manufacturers, importers, or dis- confined Entry, Search and Seizure i
dispensaries, medical and research insti
tributors of drugs, duly licensed chemists and druggists or Any authorized Gazetted officer can (o) enter and search any place in
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tutions, and
under the Drugs and Cosmetics
pharmacies duly licensed under the pro which an offence under the Act has been or is
being committed: and
Act, 1940 and Rules thereunder.
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visions of the Drugs and Cosmetics
Rules. (6) seize any document which contravenes any of the provisions of the Act.
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3. The advertiser is responsibile to prove Offences and Penalties

that any claim made in the advertise
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ment in respect of the,drug is not false, Contravention of any provision of the Act is punishable with imprison-
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exaggerated or misleading. ment upto 6 months or fine or both on first conviction, and imprisonment
upto 1 year or fine or both on any subsequent conviction. Any document,
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chemical con-
1. Advertisement relates to
traceptives for oral use having the article or thing in respect of which the contravention is made, can also be
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following composition per tablet forfeited.

5. Advertisement of chemical
con-
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traceptives for oral use (a) DL-Norgestral-0.30 mg.
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Ethinyl Estradil-0.30 mg.

Or
(b) Levo-norgestral-0.15 mg.
Ethinyl Estradil-0.03 mg.
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Insta - Study_Pharmacy_29 **********E***

Telegram - Study Pharmacy Ch-6 NARCOTIC DRUGS AND

PSYCHOTROPIC
IC
SUBSTANCES ACT AND RULES
SUB

Most significant feature bf 93

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tters". most
mos of he Act is
stances, and concerned mat ded for the offences; in some the
exemplary punishment pro0o
addition to a fine of more cases

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yeaminimum term of imprison than3
16
ngorous imprisonment upto onment
For most of the ofterOyided,
and as a conse ence, and
minimum amount of fine arePno
option but to award the once an

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of any narco minimum
Orence is proved, the court small quantit otic drug

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i or consumption of
The Narcotic Drugs and Psychotropic penalty. Even possessionronat
pers
such drug, or
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psychotropic substance or Act.

are
Substances Act and Rules cognisable offences under theth September 1985 and exter

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ds to the
The Act came in force on
may be appointed
ifferent ates
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States. for different

different
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whole of India. However.
Introduction All systems of medicine are based on natural drugs but a provisions of the Act and for
large number of synthetic drugs arë also used in allopathic or modern cotic or psychotropiC
Definitions to any
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system of medicine. Certain natural and synthetic substances are better substance:
addict means a person addicteed
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known for their non-medicinal properties. These dangerous drugs, known
to the mankind since the history of civilization, are more popular in cannabis (hemp) means rated resin, in whatever form,
modern system of medicine. Coca, hemp and opium are excellent drugs but the cannabis plant and also whether
they are habit forming and have degenerative effect on the health of the
(a) charas that is, the 5e and
ro resin known as hashish includes
Crude or purified. oil or tiquid
user. Opium was brought under legislative control as far back as in 1857. concentrated preparat
The primary aim of the Opium Act was the protection of the public welfare or fruiting tops of the cannabis
hashish;
by preserving health and eliminating undesirable social and moral effects leaves when not accon plant
may bee known or
Oganja that is, the flownd or designated;by the
commonly associated with indiscriminate use of this drug. Chinese are
(excluding the seedsathey desied
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known to have almost unbroken record of addiction to opium since time and
immemorial. Coca leaves were chewed by the natives of Peru, Bolivia and tops), by whatever na vithout any neutral material, of any
Latin American countries as early as in 15th century. Hemp is very Popular (C)any mixture, with or or any drink prepared ther
herefrom of the
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is
in Asia and Africa and particularly in India this drink mentioned as the above forms of canna the genus
of
nabis.
favourite drink of Lord Shiva, according to Hindu mythology. cannabis plant means any pla
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From time to time steps have been taken at national and international coca derivative means extract of coca leaf which can
y be used,
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level to curb this menace and threat to the physical and moral health of (o) crude cocaine, that is, aemanufacture of cocaine;
the human race, particularly. the youth. rom
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directly or indirectly To
vatives of ecgonine which
Government of India passed the Dangerous Drugs Act, 1930, with a can be
()ecogonine and all der
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view to control certain operations in dangerous drugs and to centralise and
eter of benzyl-ecgonine and its:salts;
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recovered;
vest the same in Central Government. Another purpose of the Act was to more than 0.1% of cocainee. and
()cocaine, that is, methy
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increase penalties relating to certain operations concerning the dangerous
drugs. () all preparations contal
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To keep pace with the changing times and alarming abuse these coca leaf means except
vcept the leaf from which all
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dangerous drugs required a fresh legistation. This culminated into the (a)the leaf of the coca lant
plaaonine
nave been
alkalo1as have been remgonine
removed;
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enactment of the Narcotic' Dus arid Psychotropic Substances Act and cocaine and any other thout annot ial but
The Act was passed to "consolidate and amend the law more
Rules, 1985.
() any mixture thereof
containing not
wtion than 0.1%does
relating to narcotic drugs, to make stringent provisions for the control and not include any prepa of
regulation of operations relating to narcotic drugs and psychotropic sub-
cocaine.
92
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Insta - Study_Pharmacy_29
Telegram - Study Pharmacy PHARMACEUTICAL JURISPRUDENCE Ch-6 NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES ACT AND RULES 95

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94
genus Erythroxylon; necessary to adapt it for medicinal use in accordance with the
coca plant means the plant of any species of the requirements of the Indian Pharmacopeia or any other

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commercial quantity in relation to Narcotic
Drugs and Psychotropic pharmacopceia notified in this behalf by the Central Government,
greater than the quantity specified by
Substances means any quantity whether, in powder form or granulated or mixed with neutral
Gazette.

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the Official
the Central Government by notification in materials;
the Central Government () prepared opium, that is, any product of opium obtained by any
controlled substance means any substance which as

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may, having regard to the available information to its possible use in series of operations designed to transform opium into an extract
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narcotic drugs or psychotropic sub- suitable for smoking and the dross or other residue remaining after
the production or manufacture of

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próvisions of any International Convention, by opium is smoked;
stances or to the
to be a controlled sub-
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notification in the Official Gazette, declare production means the separation of opium, poppy straw, cocoa leaves or
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stance; cannabis from the plants from which they are obtained;
Psychotropic Substances
small quantity in relation to Narcotic Drugs and specified by the Central psychotropic substance means any substance, natural or synthetic, or any
means any quantity greater than the quantity natural material or amy salt or preparation of such substance or material
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Government by notification in the Official Gazette. included in the list of psychotropic subštances specified in the Sched-
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psychotropic substances,
manufacture in relation to narcotic drugs or ule;
include ilicit traffic, in relation to narcotic drugs and psychotropic substances
by which drugs or substances
(a) all processes other than production means,
may be obtained; cultivating any coca plant or gathering any portion of coca plant;
(6) refining of such drugs or substances; () cultivating the opium poppy or any cannabis plant;
()transformation of such drugs or substances; and () engaging in the production, manufacture, possession, sale, pur-
in a pharmacy on prescrip- use or
(d) making of preparation (otherwise than chase, transportation, warehousing, concealment,
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or substances. consumption, import inter-State, export into India, export from
tion) with or containing such drugs
derivatives, medicinal cannabis, India or transhipment, of narcotic drugs or psychotropic sub-
manufactured drugss means (a) all coca
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poppy straw concentrate; stances;
opium derivatives and
(6) any other narcotic substance or
preparation which the Central Gv)dealíng in any activities in narcotic drugs or psychotropic sub-
the available 'information as to stances other than those provided in sub-clauses () to (in); or
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Government may, having regard to
nature, or to a decision, if any, under any Intemational () handling or letting ,any premises for the carrying on of any of the
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its Gazette, declare to be a
Convention, by notification in the Official activities referred to in sub-clauses (1) to (iii), other than those
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include any narcotic.substance or permitted under the Narcotic Drugs and Psychotropic Substances
manufactured drug,.but does not
preparation declared not to be manufactured drug Act, 1985, or any rules or order made, or any condition of any
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(hemp), opium, poppy straw and licence or authorization issued thereunder, and includes
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narcotic drug means coca leaf, cannabis (a) financing directly or indirectly, any of the aforementioned
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includes all manufactured drugs; activities; and
(6) abetting or conspiring in the furtherance of or in support of
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opium means
poppy; and
() the coagulated juice of the opium doing any of the aforementioned activities; and
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any neutral material of the coagulated (C)harbouring persons engaged in any of the aforementioned
(6) any rixture, with or without
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opium poppy but does not include any preparation activities;

juice of the
containing not more than 0.2% of morphine; In the context of 'illicit traffie in relation to narcotic drugs and
opium derivative means psyehotropic substances the Central Government has specified the
has undergone thee process "small quantity" of the following drugs:
() medicinal opium, that is, opium which
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Insta - Study_Pharmacy_29
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96 Pharmacy PHARMACEUTICAL JURISPRUDENCE Ch-6 NARCOTIC ORUGS AND PSYCHOTROPIC
SUBSTANCES ACT AND RULES
97

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Power of Central Government to permit,
Cocaine 125 mg ject to the above provisions, Central Government
control and regulate Sub-
Heroin or Brown Sugar of Smack : 250 mg may, by rules,

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Hahish or Charas 5.grams (a) permit and regulate-
Opium: 5 grams ) cultivation and gathering of any portion (only
on behalf of the
Central Government) of coca plant, or the production,

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Ganja 500 gram posses-
sion, sale, purchase, transport, inter-State
to transport means to take from one place to another within the same import and export,

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use or consumption of coca leaves;
State or Union territory. (i) cultivation (only on behalf of the Central
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Com Government) of the

The Narcotic Drugs and Psychotropic Substances Consultative opium poppy,

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mittee This Committee is constituted by the Central Government to advise ii) production and manufacture of opium and productiorn
the Central Government on such matters relating to the administration of of poppy
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straw;
this. Committee shall consist of a Chairman and such other members, not
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(iv) sale of opium and opium derivatives
exceeding twenty, as may be appointed by the Central Government. It
from Central Government
factories for export from India or sale to State Government
shall meet when required by the Central Government to do so and shall to manufacturing chemists; or
have power to regulate its own procedure. Committee is also empowered,
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() manufacture of manufactured drugs (other
for the efficient discharge of any of its functions, to constitute oneor than prepared opium)
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but not including manufacture of medicinal
more sub-committees. opium or any
preparation containing any manufactured drug from
materials
which the maker is legally entitled to possess;
PROHIBITION, CONTROL AND REGULATION (vi) manufacture, possession, transport,
inter-State import and ex-
port, sale, purchase, consumption or use
Prohibition of certain operations No person shall of psychotropic
substance; and
(a) cultivate any coca plant or gather.any portion of the coca plant; or (b) prescribe any other requisite to render effective
(6) cultivate the op?um or any cannabis plant; or Central Government over any of the matters
the control of
specified above.
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(c) produce, manufacture, possess, sell, purchase, transport, ware- Power to control and regulate
house, use, consume, import and export inter-State, or transship any cotrolled substances If Central
Government is of the opinion that having
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narcotic drug or psychotropic substance; except for medical or scientific controlled substances in the production or
regard to the use of any
purpose and in the manner and to the extent prescribed or in accordance drug or psychotropic substance, it is necessary
manufacture of any narcotic
with the terms and conditions of a licence, permit, or authorization: public interest, it may, by order, provide for
or expedient so to do in the
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Provided that the prohibition against cultivation of cannabis plant for
regulating or prohibiting the
production, manufacture, supply. and distribution
thereof and trade and
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the production of ganja or production, possession, use, consumption, commerce therein.
purchase, sale, transport, warehousing, inter-State import and export of
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Without prejudice to the generality of

ganja for any purpose other than medical and scientific, shall take effect Order made thereunder may provide for
the power conferred above, an
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only from the date specified by the Central Govermment. regulating by licences, permits or
otherwise, the production, manufacture,
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possession, transport, import in-

Central Government may also permit on its behalf the cultivation of any ter-State, export inter-State, sale, purchase,
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coca plant or gathering of any part thereof, or production, possession,
consumption, use, storage,
distribution, disposal or acquisition of any controlled
sale, purchase, transport, inter-State import and export, or import into
substance.
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Powers of State Government to permit,

India of coca leaves for use in the preparation of any favouring agent control
to the provisions of the Act, the State Government and regulate Subject
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which shall not contain any alkaloid and te the extent necessary for such may, by Rules,
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use. Central Government may also y oider, allow cultivation of any (a) permit and regulate
cannabis plant for the industrial purposes only for obtaining fibre or seed )possession, transport, inter-State import and export, warèhous-
or for horticultural purpose. ing, sale, purchase, consumption and
use of poppy straw;
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Insta - Study_Pharmacy_29
Telegram - Study Pharmacy PHARMACEUTICAL JURISPRUDENCE Ch-6 NARCO7IC DRUGS AND PSYCHOTROPIC SUBSTANCES ACT AND RULES 99

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(i) possession, transport, inter-State import and
export, sale, (1) (2)

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purchase, consumption and use of opium 2. In relation to coca plant and Rigorous imprisonment up to 10 years or
production, manufacture,
ii) cultivation of any cannabis plant, coca leaves: to cultivate any fine up to7 1 lakh.
possession, transport, inter-State import and export, sale, coca plant or gather any portion

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purchase, consumption or use of cannabis (excluding charas); of a coca plant or produce, pos-
containing
(iv) manufacture of medicinal opium or any preparation
sess, sel, purchase, transport,

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drug from materials which the maker is import inter-State, export inter-
any manufactured
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State or use coca leaves, in

legally entitled to possess; contravention of this Act or Rules

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(v)possession, transport, purchase, sale, inter-State import than
and
etc.,
other
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export, use or consumption of manufactured drugs

contain- 3. In relation to prepared opium :
opium and of coca leaf and any preparation
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prepared to manufacture, possess, sell, pur
ing any manufactured drug: cháse, transport, import
prepared opium from opium
(vi) manufacture and possession of inter-State, export inter-State or
lawfully possessed by an addict registered with the State
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use prepared opium in contraven-
consumption;
Government. on medical advice for his personal
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tion of this Act or Rules etc.,
and (a) where the contravention involves Rigorous imprisonment up to 6 months
render effective the control small quantity or fine upP to ? 10,000 or both
(6) prescribe any other matter requisite to
Government over any of the matters specified above. (6) where the contravention involves Rigorous imprisonment up to 10 years or
of the State lesser than commercial quantity fine up to 1 lakh.
but greater than small quantity
OFFENCES AND PENALITES Rigorous imprisonment for not less than
(c)where the contravention involves
Offence Penalty commercial quantity 10 to 20 years and fine not less than 1
lakh to R 2 lakh.
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First Conviction Court may impose a fine exceeding 2
(2) lakh.
(1)
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1. Ii relation to poppy straw: to
4. In relation
opium: to
to opium poppy&
cultivate the opium
produce, possess, transport, in- poppy or produce. manufacture,
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ter-State import or export, sell possess, sell, purchase, transpot,
purchase, use or omit to ware- import inter-State, export. inter
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house poppy straw or to remove State or use opium in contraven-
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or to do any act in respect tion of this Act or Rules etc.,

warehoused poppy straw, in con
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(a) where the contravention involves Rigorous imprisonment up to 6 months
travention of this Act or Rules small quantity or fine up to 7 10,000 or both
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etc.
Rigorous imprisonment up to 6 months (b) where the contravention involves Rigorous imprisonment for not less than
(o) where the contravention involves
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small quantity
pr fine up to 10,000 or both commercial quantity 10to 20 years and fine not less than 1

Rigorous imprisonment up to 10
years or lakh to 2 lakh.
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(6) where the contravention involves Court may impose a fine exceeding R 2
fine up to 1 lakh.
lesser than commercial quantity
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lakh.
but greater than small quantity
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Rigorous imprisonment for not less than () in any other case Riggous nprisonment ip to 10 years or
)where the contravention involves fineup to 7 1 lakh.
commercial quantity 10 to 20 years and fine not less than
1 lakh to 2 lakh.
Court may impose a fine exceedingg
7 2 lakh.
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Insta - Study_Pharmacy_29
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100 PHARMACEUTICAL JURISPRUDENCE

Ch-6 NARCOTIC DRUGS AND PSYCHOTROPIC

SUBSTANCES ACT AND RULES

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101
(1) (2)
Rigorous imprisonment for not less than (2) (2)

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5. Embezzlement of opium by cul-
tivators: 10 to 20 years and fine not, less than 1
Court may. impose a fine exceeding 2
Embezzlement or otherwise ille- lakh to 2 lakh.
lakh.
Court may impose a fine exceeding 2

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gally disposing of the opium 8. In relation to' psychotropic sub-
produced or any part thereof by lakh.
stances:

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cultivator licensed co cultivate the to manufacture, possess, sell, pur-
opium poppy on account of the
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Central Government chase, transport, import

inter-State, export inter-State or

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6. In relation to cannabis plant and use any manufactured drug or
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cannabis psychotropic substance in contra-

Rigorous imprisonment up to 10 years or
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(o) to cultivate any cannabis plant, or vention of this Act or Rules etc.,
(b) to produce, manufacture, possess, fine up to7 1 lakh. ()where the contravention involves Rigorous imprisonment' up to 6 months
sell, purchase, transport, import small quantity or fine up to 10,000, or both
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inter-State, export inter-State or (i) where the contravention involves Rigorous imprisonment up to 10 years or
use cannabis in contravention of
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lesser than commercial quantity

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fine up to 1 lakh.
this Act or Rules etc., but greater than small quantity
(i) where the contravention involves Rigorous imprisonment up to 6 months (i) where the contravention involves Rigorous imprisonment for not less than
small quantity or fine up to 7 10,000, or both commercial quantity 10 to 20 years and fine not less than 1
(i) where the contravention involves Rigorous imprisonment up to 10 years or lakh to 2 lakh.
lesser than commercial quantity fine up to 1 lakh.
Court may impose a fine exceeding 2
but greater than small quantity lakh.
(ii) where the contravention involves Rigorous imprisonment for not less than 9. Illegal import, export or trans-
commercial quantity 10 to 20 years and fine nut less than 1 shipment of narcotic drugs and
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lakh to 2 lakh. psychotropic substances: to im-
Court may impose a fine exceeding ? 2 port into India or export from
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lakh. India or transship any narcotic
drug or psychotropic substance in
7. In relation to manufactured
drugs and preparations: contravention of this Act or Rules
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to manutacture, possess, sell, pur- etc.,
chase, transport, import () where the contravention inyolves Rigorous imprisonment up to 6 months
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inter-State, export inter-State or small quantity or fine up to R 10,000, or both
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use any manufactured drug/any (i) where the contravention involves Rigorous imprisonment up to 10 years or
preparation containing any manu- lesser than commercial quantity
fine up to 1 lakh.
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factured drug in contravention of but greater than small quantity
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this Act or Rules etc., (i) where the contravention involves Rigorous imprisonment for not less than
Rigorous imprisonment up to
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() where the contravention involves 6months commercial quantity 10 to 20 years and fine not less than1
small quantity or fine up to 10,000, or both
lakh to 2 lakh.
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(i) where the contravention involves Rigorous imprisonment up to 10 years or Court may impose a fine exceeding 7 2
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lesser than commercial quantity fine up to. 1 lakh. lakh.
but greater than small quantity
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10. External dealings in narcotic Rigorous imprisonment for not less than
(ii) where the contravention involves Rigroüs imiprisonment for not less than drugs and psychotropic sub- 10 to 20 years and fine not less than
commercial quantity 10 to 20 years and fine not less than 1 1
stances: to engage in or control lakhto 2 lakh.
lakh to R 2 lakh. any trade whereby a narcotic druug Court may impose a fine exceding 7 2
or psychotropic substance is ob- lakh.
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Insta - Study_Pharmacy_29
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Ch-6 NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES ACT AND RULES 103

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102 (2)
(1)
(1) (2)

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is not prescribed anywhere in this
Act;
tained outside India and supplied
13. Financing illicit traffic and har- Rigorous imprisonment for not less than
to any person outside India with-

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bouring offenders: whoever 10 to 20 years and fine not less than
out the previous authorization of lakh
Central Government or otherwise indulges in financing directly or 71 lakh to 2

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indirectly; or harbours offenders Court may impose a fine exceeding
than in accordance with the con-
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engaged in any of the activities 7 2 lakh.

ditions of such authorization
granted under section 12. specified under the definition of

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for that
Same punishment as provided 'illicit traffic
11. Allowing premises etc. to
be
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used for commission of an of offence 14. Consumption of narcotic drug or

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owner psychotropic substance:
fence: anybody being the control
or occupier or having the (a) where the narcotic drug or psy- Rigorous imprisonment up to 1 year or
or use of any house, room, enclo chotropic substance consumed is fine up to7 20,000 or with both
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sure, space, place, animal or cocaine, morphine, diacetyl mor-
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conveyance, knowingly permitting

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phine or any other specified

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any narcotic drug or psychotropic sub-
to use for the commission by
pun-
other person of an offence stance
ishable under any provision of (6) other than those specified in (o) Rigorous imprisonment up to 6 months
this Act or fineup to 10,000 or with both
Imprisonment up to 3 years or with fine
12. Certain acts by licensee or
his 15. Attempts to commit offences Same punish ment as provided for that
or with both offence
servants:
If the holder of any license, per- 16. Abetment and criminal con- Same punishment as provided for that
mit or authorization granted under
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Rule made there spiraty: (whether the offence be offence
this Act or be not committed)
under or any person in his em-
ploy and acting on his behalf 17. Offence for which no punish- Imprisonment up to 6 months or with
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cause, ment provided: fine or with both
(a) omits, without reasonable
to maintain accounts or to sub- 18. Enhanced punishment for of For second and subsequent offence
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mit any return in accordance
with fences after previous conviction: rigorous imprisonment up to one half of
the provisions of this Act or any maximum term and fine up to one half
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Rule made there under; of the maximum amount
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(6) fails to produce without any

rea- Punishable with death
19. Death penalty for certain of-
sonable cause such license, permit Any person who has
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of
fences
or authorization on demand been convicted of the commis
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any officer authorized by the Cen- sion of, or attempt to commit, or

State
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tral Government or abetment of, or criminal con-
Government in this behalf; spiracy to commit offences under
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any (5). (10), (14a) and for offences

keepS any accounts or makes
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statement which is false or which involving commercial quantity of
he knows or has reasons to be any narcotic drug or psychotropic
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ieve to be incorrect; or substance, is subsequently con

(d) wilfully and knowingty does
any victed of similar offence relating
con to
act in breach of any of the
ditions of license,. permit or
authorization for which a penalty
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Insta - Study_Pharmacy_29
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104 PHARMACEUTICAL JURISPRUDENCE Ch-6 NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES ACT
AND RULES
105

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SCHEDULE
(7) (2) I (RULES)
Psychotropic substances whose import, export and transshipment are

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(a) engaging in the production,
manufacture, possession, transpor prohibited:
tation, import, export, 1. Coca Leaf

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transshipment of the narcotic drug 2.Cannabis (Hemp)
or psychotropic substance in equal

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or more quantity than specified 3. (a) Acetorphine
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in Table under Section 31A; (b) Diacetylmorphine (Heroin)

(b) financing directly or indirectly, (c) Dihydrodesoxymorphine (Desomorphine)

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any of the activiiies specified (d) Etorphine
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above (e) Ketobemidone

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and their salts, preparations, admixtures, extracts and other
Note: No sentence awarded under this Act except under (14) above shall be
suspended or remitted or commuted.
substances containing any of these drugs.
Psychotropic substances whose manufacture, possession, transport, im-
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SCHEDULE (ACT) port inter-State, export inter-State sale, purchase, consumption or use
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are
prohibited:
List of Psychotropic Substances i
DET, DMHP, DMT, (+)-Lysergide, (LSD, LSD25), mescaline, parahexyl,
Etryptamine, Methaqualone, Methcathinone; their salts and preparations.
Eticyclidine, Rolicyclidine, psilocine, psilostin, Psilocybine, STP, DOM,
Tenocyclidine, THC, DOB, MDA, Amphetamine, Dexamphetamine, SCHEDULE II (RULES)
Mecloqualone, Methamphetamine, Methaqualone, Methyl-phenidate, Phen- Psychotropic substances not allowed to be exported to specified coun-
cyclidine, Phenmetrazine, Amobarbital, Cyclobarbital, Glutethimide, tries (in brackets)
Pentazoxine, Pentobarbital, Secobarbital, Alprazolam, Amfepramone, Barbital,
Alprazolam, Barbitai, Cyclobarbital, (Pakistan)
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Benzphetamine, Bromazepam, Camazepam, Chlordiazepoxide, Clobazam,
Ethchlorvynol, Flurazepam,
Clonazepam, Clorazepate, Cloiazepam, Cloxazolam, Delorazepam, Diazepam,
Halazepam, Nordazepam
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Estazolam, Ethchlorvynol, Ethinamate, Ethyloflazepate, Fludiazepam,
Flunitrazepam, Flurazepam, Halazepam, Haloxazolam, Ketazolam, Lefetamine, Amphetamine, Dexamphetamine (Belize, Japan, Nigeria, Pakistan,
Loprazolam, Lorazepam, Lormetazepam, Mazindol, Medazepam, Meprobainate, Methamphetamine Senegal, Thialnad, Turkey, Yemen,
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Methylphenobarbital, Methyprylon, Nimetazepam, Nitrazepam, Nordazepam, Venezuela)
Oxazepam, Oxazolam, Phendimetrazine, Phenobarbital, Phentermine, Fentalline
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(Belize, Saudi Arabia, Thailand)
Pinazempam, Prazepam, Temazepam, Tatazepam, Triazolam, Cathione, DMA, Glutethemide
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MDMA, 4-Methylaminorex, MMDA, N-Ethyl MDA, N-Hydroxy MDA, PMA, TMA,

(Chile, Pakistan)
Levamfetamine, (Belize, Japan, Thailand,
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Fenetylline, Levamfetamine, Metamfetamine. Racemate, Byprenorphine,
Levomethamphetamine Venezuela)
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Butalbital, Cathine, Allobarbital, Etilaamfetamine, Fencamfetamine,

Penproporex, Mefenorex, Midazolam, Pemoline, Pyrovaerone, Secbutabarbital Mecloqualone (Argentina, Belize, Chile, Pakistan)
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Vinylbital, Butobarbital, Etryptamine, Methacathinone, Zipeprol, Aminorex, Metamfetamine racemate (Belize, Japan, Venezuela)
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Brotizolam, Mesocarb, 2C-B (4-bromo-2,5-dimethozyphenethylamine), 4- Methylphenidate (Belize, Nigeria, Senegal, Thailand,

MTA (a-Methyl-4-Methyl-thiophenethylamine, GHB (r-Hydroxybutyric acid),
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Turkey, Yemen)
Zolpidem, Amineptine (7-[10, 11-dihydro-5H-dienzc [a,d] cyclohapten-5 yl
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Methylphenobarbital (Pakistan, Senegal, Yemen)

amino] heptanoic acid)]1. Ketamine.
Pemoline (Nigeria, Thailand)
Salts and preparations of above. Phencyclidine (Belize, Chile, Iceland; Nigeria, Pa-
kistan, Senegal, Yemen)
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Insta - Study_Pharmacy_29
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- Study Pharmacy PHARMACEUTICAL JURISPRUDENCE

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Phenmetrazine (Belize, Chile, Nigeria, Pakistan,
Senegal, Thailand, Yemen, Ven-

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ezuela)
Secobarbital (Belize, Nigeria, Pakistan)

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SCHEDULE I1I (RULES)

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The Drugs (Prices Control) Order, 2013
manufacture of psychotropic substances for export
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[Grant of licence for

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only.
Amfepramone, Aminorex, Bromazepam, Brotizolam, Camazepam,
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Estazolam, Ethinamate, Drugs are legally recognized as 'essential commodity' and all essential
Clorazepam, Clitiazepam, Cloxazolam, Delorazepam,
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reason-
Ethylloflazepate, Fludiazepam, Haloxazolam, Ketazolam,
Lefetamine, commodities should always be available to the general public at a
Mesocarb, Methyprylon, In absence of any statutory control a manufacturer could sell his
Loprazolam, Lometazepam, Mazindol, Medazepam, able price.
public interest but
Oxazolam, Phendimetrazine, Phentermine, Pinazepam, drugs at exorbitant prices, which is not only against
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Nimetazepam,
Pipradrol, Prazepam, Temazepam, Tetrazepam,
Zipeprol; salts and prepara- also against the concept of welfare State. Under section 3 of the Essential
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Commodities Act, 1955 the Central Government is empowered to control
tions of above. includ-
the production, supply, distribution etc. of essential commodities,
ing drugs.
The Drugs (Prices Control) Order, 2013 has been promulgated to ensure
equitable distribution of essential bulk drugs and to fix the maximum retail
prices of drug formulations in order to curb the exorbitant profiteering in
drug manufacturing and distribution.
The DPCO 2013 came in effect from 15th May, 2013 and extends to the
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whole of India. It has replaced the Drugs (Prices Control) Order, 1995.
The Order has the following Schedules:
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Schedule I: It contains the National List of Essential Medicines, 2011;
divided into 27 Sections
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Schedule II : It contains various forms for approval or revision of prices
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of Scheduled Forinulations.
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Definitions i
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feature
brand means a name, term, design, symbol, trademark or any other
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one seller's drug as distinct from those of other sellers;

that identifies
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ceiling price means a price fixed by the Government for Scheduled
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formulations in accordance with the provisions of this Order;

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or sale of
dealer means a person carrying on the business of purchaseagent;
and ircludrs his
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drugs, whether as a wholesaler or retailer

distributor means a person engaged in the work of distribution of drugsa
to
and includes an agent or a stockist for stocking drugs for sale
dealer;
107
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108 PHARMACEUTICAL JURISPRUDENCE
Ch-7 DRUGS (PRICES CONTROL) ORDER, 2013 109

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pharmacoeconomics means a scientific discipline that compares the thera-
formulation means a medicine processed out of or containing one or more peutic value of one pharmaceutical drug or drug therapy to another;
drugs with or without use of any pharmaceutical aids, for internal or

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price list means a price list referred to in paragraphs 24 and 25 and
external use for or in the agnosis, tre tment, mitigation or prevention
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includes a supplementary price list;

of disease in human beings or animals, but shall not include
price to retailer means the price of a drug at which it is sold to a retailer

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() any medicine included in any bonafide Ayurvedic (including Sidha) which includes duties but does not include local taxes;
or Unani (Tibb) systems of medicines;

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(n) any medicine included in the Homeopathic system of medicine; and
retail price means the price fixed by the Government for a new drug;
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(ii) any substance to which the provisions of the Drugs and Cosmetics retailer means a dealer carrying on the retail business of sale of drugs to

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Act, 1940 do not apply; Customers;
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generic version of a medicine means a formulation sold in pharmacopeial scheduled formulation means any formulation, included in the First
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name or the name of the active pharmaceutical ingredient contained in Schedule whether referred to by generic versions or brand name;
the formulation, without any brand name; wholesaler means a dealer or his agent or a stockist engaged in the sale of
local taxes means any tax or levw (except excise or import duty included in drugs to a retailer, hospital, dispensary, medical, educational or re-
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search institution or any other agency.
retait price) paid or payable to the Government or the State Government
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or any local body under any law for the time being in force by the
manufacturer or his agent or dealer;
Sale Prices of Scheduled Formulations
Margin to retailer : A margin of 16% to retailer shall be allowed while
margin to retailer means a percentage of price to retailer; fixing a ceiling price of scheduled formulations and retail prices of new
maximum retail price (MRP) means the ceiling price or the retail price drugs.
plus local taxes and duties as applicable, at which the drug shall be Maximum retail price
sold to the ultimate consumer and where such price is mentioned on
MRP of scheduled formulations - Ceiling price + Local Taxes
the pack;
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as applicable
moving annual turnover in a particular month means cumulative sales
MRP of a new drug = Retail Price + Local Taxes as applicable
value for 12 months in domestic market, where the sales value of that
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month is added and the corresponding sales of the same month in the Thus in case of scheduled formulations the MRP is based on ceiling
previous year are subtracted; price while in case of a new drug it is based on retail price.
National List of Essential Medicines means National List of Essential
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Pricing of the scheduled formulations covered under Drugs (Prices
Medicines, 2011 published by the Ministry of Health and Family Welfare Control) Order, 1995: Prices of scheduled formulations shall remain
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as updated or revised from time to time and included in the First effective up to 30th May, 2013 and the manufacturers may revise the prices
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Schedule of this order by the Government through a notification in the of such scheduled formulations as per the annual wholesale price index for
Official Gazette;
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the previous calendar year announced by Department of Industrial Promo-
new drug means a formulation launched by an existing manufacturer of a tion and Policy and thereafter the formula as in sub- paragraph (1) of
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drug of specified dosages and strengths, as listed in the National List of paragraph 4 of this Order shall be applied for fixing the ceiling prices of
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Essential Medicines (NLEM) by combining the drug with another drug such formulations.
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either listed or not listed in the NLEM or a formulation launched by Prices of scheduled formulations specified in the First Schedule to
the
changing the strength or dosages or both of the same drug of specified
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Drugs (Prices Control) Order, 1995, fixed and notified under the provisions
dosages and strengths as listed in the NLEM. of Drugs (Prices Control) Order, 1995 after 31st May, 2012, shall remain
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non-scheduled fornmulation means a formulation, the dosage and strengths effective for one year from the date of notification of such' prices under
of which are not specified in the First Schedule Drugs (Prices Control) Order, 1995 and immediately thereafter the manufac-
turers may revise the prices as per the annual wholesale price index for the

'
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Insta - Study_Pharmacy_29
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Ch-7 DRUGS (PRICES CONTROL) ORDER, 2013 111
110

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of Industrial Promotion the Government, shall revise the prices of ll such formulations downward
previous calendar year announced by Department
financial year, the formula as not exceeding the ceiting price (plus local taxes as applicable).

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and Policy and on the 1st April of succeeding
shall be applied for fixin9 Provided that in case of scheduled fornr ulations produced or available in
in sub-paragraph (1) of paragraph 4 of this
Order
the ceiling prices of such schedule formulations. the market before date of notification sf ceiling price, the manufacturers

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specified in the Drugs shall ensure within a period of 45 days of the date of such notification
Prices of scheduled formulations, which are
First Schedule of this that the MRP of such scheduled formulation does not exceed the ceiling

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specified in the
(Prices Control) Order, 1995 but not price (plus local taxes as applicable).
of the said order, up to 31st
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Order, fixed and notified under the provisions

year i.e. up to the 30th All the existing manufactures of scheduled formulations, selling the
May, 2012, shali remain effective for further one

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formulations shall be regulated as branded or generic or both the versions of scheduled formulations at a
May' 2013 and hereafter prices of such
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non-scheduled formulations as stated in paragraph 20 of price lower than the ceiling price (plus local taxes as applicable) so fixed
in case of other
and.notified by the Government shall maintain their existing MRP.
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this Order.
specified in the Drugs Annual increase in MRP may be carried out as per the increase in the
Prices of scheduled formulations, which are
Fîrst Schedule of this wholesale price index with respect to previous year.
(Prices Control) Order, 1995 but not specified in the
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the provisions of the said order, after 31st Provided that in case of decline in wholesale price index, a correspond-
order, fixed and notified under
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May, 2012, shall remain effective for
one year from the date of notification ing reduction in the prices shall be made as per the provision of
thereafter prices of such formulations shall be regulated sub-paragraph (4) of paragraph 16.
of such prices and
formulations as stated in paragraph 20
as in case of other non-scheduled Fixation of retail price of a new drug for existing manufacturers of
of this Order.
scheduled formulations: (1) Government shall form a Standing Committee
Average price to retailer
Ceiling price or retail price of a pack : (1) of Experts to recommend the retail prices of new drugs on the principles of
tablet, per capsule or
shall be calculated on the dosage basis, (per "Pharmacoeconomics".
as listed in First Schedule) and the ceiling price. or
injection in volume (2) Where an existing manufacturer of a drug with dosages and
multiplying the same with the
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retail price of a pack shall be reached by
may be. strengths as specified in NLEM launches a new drug, such existing manufac-
number or quantity in the pack, as the case turers shall apply for prior price approval of such new drug from the
for a scheduled formulation
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(2) In the event of the unit of the dosage Government in Form-I under Schedule-II of this Order.
the lowest pack size for that category
not available in the First Schedule, Act, 1940 and. the On receipt of such application, in the event of the new drug available
Drugs and Cosmetics
of medicine, as specified in the in domestic market, the Government shall fix retail price of new drug in
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shall be taken as unit dosage for calculating the ceiling
rules thereunder,
scheduled formulation and accordance, while in the event of new drug not available in domestic
price or retail price as the case may be, for that
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per unit price of even non- market, Government shall forward the same to the Standing Committee of
applicable while calculating the
Experts who shall examine the application on the principles
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this shall be
scheduled medicines for arriving at the retail price.
PharmacoeconomicS and make recommendations of retail price of the new
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A manufacturer, launching
Price of formulations listed in the NLEM: drug to the Govenment within 30 days of the receipt of application.
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a scheduled formulation, shall be free to

fix the price of the scheduled
price fixed for that scheduled Government shall, on receipt of recommendation of the Standing
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formulation equal to or below the ceiling
Committee of Experts fix the retail price of such new drug and such price
formulation by the Government.
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shall be applicable to such applicant of such new drug.

by another manufacturer the
Where an existing brand is re-launched
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Where existing manufacturer of scheduled formulation fails to apply for
paragraph 13 shall be applicable.
provisions of prior approval of the price of new drug in Form-I, such marfacturer shall
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manufacturers be liable to deposit the overcharged amount over 'ariu abòve such price
Price of scheduled förmulations for the
existing
manufacturés of scheduled formulations, selling the branded fixed and notified by the Government, if any, along with interest thereon
(1) All existing
or generic or both versions of
scheduled formulations at a price higher from the date of launch of the new drug, in addition to the penalty.
so fixed and notified by
than ceiling price (plus local taxes as applicable)
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112 PHARMACEUTICAL JURISPRUDENCE
Ch-7 DRUGS (PRICES CONTROL) ORDER, 2013
113

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(6) No existing manufacturer of a scheduled formulation shall sell such The medicines omitted from the First
a new drug at a price higher than the retail price (plus local taxes as Schedule shall automatically fall
under the category of non-scheduled formulations.
applicable) fixed by the Government for such new drug and in case such a

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manufacturer is found to sell such a new drug at a price higher than the Fixation of ceiling price of a drug in public
interest : In public
retail price (plus local taxes as applicable) fixed by the Government, such interest the Government may fix the ceiling price or retail price
of any drug

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manufacturer of the new drug shall be liable to deposit the overcharged for such period, as it may deem fit; and where the
ceiling price or retail
amount along with interest from the date of overcharge, in addition to the price of the drug is already fixed and notified, the Government

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may allow
penalty. an increase or decrease in the ceiling price or the
retail price, as the case
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may be, irrespective of annual wholesale price

Revision of ceiling price of scheduled formulations: Government index for that year.

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shall revise the ceiling prices of scheduled formulations as per the annual Monitoring the availability of scheduled formulations
Government
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wholesale price index (WPI) for preceding calendar year on or before 1st shall monitor production and availability of scheduled formulations
and
active pharmaceutical ingredients (API) contained in scheduled formulation
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April of every year and notify the same on the 1st day of April every year.
Manufacturers may increase the MRP of scheduled formulations once in and manufacturer of scheduled formulations and the API
contained in the
a year, in the month of April, on the basis of the wholesale price index. scheduled formulation shall furnish the information as
stated in Form-III of
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However the information about the revision, if caried out, shall be schedule-II of this Order quarterly.
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forwarded to the Government in either electronic or physical form in Form- Any manufacturer of scheduled formulation,
intending to discontinue
II within a period of 15 days of such revision and non-submission of such any scheduled formulation from the market
shall issue a public notice and
information shall be taken as non revision of maximum retail price (MRP) also intimate the Government in Form-IV of schedule-II of
this Order in
and the concerned manufacturer shall be liable to deposit the amount this regard at least 6 months prior to the intended date of
charged over and above the pre-revised MRP, alongwith interest thereon and the Government may, in public interest, discontinuation
from the date of overcharging.
direct the manufacturer of the
scheduled formulation to continue with required level
of production or
In the event of decline in wholesale price index, there shall be a import for a period not exceeding 1 year, from the
intended date of such
corresponding reduction in the MRP and in case of scheduled formulations discontinuation within a period of 60 days of receipt uf such
intimation.
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produced or available in the market before the date of notification of Carrying into effect the price fixed or
revised ceiling price, the manufacturers shal ensure within a period of 45 revised by the Government,
its display and proof thereof: For all the scheduled formulations
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days of the date of such notification that the MRP of such scheduled MRP higher than ceiling price (plus local having
formulation does not exceed the revised ceiling price (plus local taxes as taxes as applicable), the manufac-
tures shall revise the MRP not exceeding the ceiling price (plus
applicable) and information about the revision shall be sent to the as applicable). local taxes
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Government in either electronic or physical form in Form-II within a period
Provided that in case of scheduled formulations
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of 15 days of such revision. produced or available in
the market before the date of notification of ceiling
Non-submission of such information shall be taken as non reduction in price, the manufactur-
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MRP and the concerned manufacturer shall be liable to deposit the amount
ers shall ensure that the MRP of such scheduled formulation
exceed the ceiling price (plus local taxes as applicable). does not
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charged over and above the MRP revised based on dectine in wholesale
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price index, alongwith interest thereon as overcharged amount from the Every manufacturer of a schedule formulation
intended for sale shall
display in indelible print mark, on the label of
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date of overcharging. container of the formulation
and the minimum pack thereof offered for
retail sale, the MRP of that
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Amendment to the list of scheduled formulations : A decision to formulation with the words Maximum Retail Price'
amend the First Schedule shall be taken by the Goyernment within 60 days preceding it and the
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words 'inclusive of al taxes' succeeding it.
of receipt of communication from the Ministry of Health and Family Welfare
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and the amendment() or revision, if required, in the First Sltkedule shall Every manufacturer shall issue a price list
and supplementary price list,
be notified and thereafter, the .ceiling price(s) for the medicine(s) added in if required to the dealers, State Drugs Controllers
and the Government
the First Schedule shall be fixed as per the provisions of this Order within a indicating reference to such price fixation or revision
as covered by the
Order or Gazette notification issued by
period of 60 days from the date of the notification. the Government, from time to time.
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Telegram 114- Study Pharmacy PHARMACEUTICAL JURISPRUDENCE Ch-7 DRUGSs (PRICES CONTROL) ORDER, 2013 115

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supplementaryy (b) no dealer shall withhold from sale or refuse to sell any drug available
Every retailer and dealer shall display price list and part with him'to a customer intending to purchase such drug.
manufacturer, on a conspicuous

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price list, if any, as furnished by the
carries on business in a manner so as to be easily Power of entry, search and seizure: Any authorised Gazetted Officer
of the premises where he
accessible to any person wishing to consult the
same. of the Central Government or a State Government may, with a view to

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securing compliance with this Order or to satisfy himself that the provision
FORMULATIONS of this Order have been complied with:

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NON-SCHEDULED
: (1) Govern- ) enter and search any place:
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Monitoring the prices of non-Scheduled formulations non-scheduled

including (i') seize any drug. alongwith the containers, packages or coverings in
ment shall monitor the MRP of all the drugs,

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MRP ofa drug which the drug is found, in respect of which he suspects that any
formulations and ensure that no manufacturer increases the
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months and where the increase is provision of this Order has been, is being, or is about to be
by more than 10% during preceding 12
contravened, and thereafter take all measures necessary for secur-
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level of 10% of MRP
beyond 10% of MRP it shall reduce the same to the ing production of the drug, containers, packages or coverings, so
for next 12 months. Manufacturer shall be liable
to deposit the overcharged
from the date of increase in price in seized, in a court of aw and for their safe custody pending such
amount along with interest thereon
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production;
addition to the penalty.
seize any document, such as cash memo or credit memo books,
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price list ()
Display of prices of non-Scheduled formulations and books of account and records of purchase and sale of the drugs in
of a non-Scheduled formulation intended for
thereof : Every manufacturer respect of which he suspects that any provision of this Order has
on the label of container of the
sale shall display in indelible print mark, for retail sale, the MRP been, is being, or is about to be contravened.
formulation and the minimum pack thereof offered
Retail Price" preceding it and Exemptions: The provisions of this Order shall not apply to:
of that formulation with the words "Maximum
succeeding it. a manufacturer producing a new drug patented under the Indian
the wordsinclusive of all taxes'
Every manufacturer shall issue a price list and
supplementary price list Patent Act, 1970 (product patent) and not produced elsewhere, if
indicating changes,
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Drugs Controllers and Government developed through indigenous Research and Development, for a
to dealers, State
period of 5 years from the date of commencement of its commer
from time to time.
cial production in the country:
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supplemen
Every retailer and dealer shatt display the price list and the
tary price list, if any, as furnished by manufacturer or importer, on a () a manufacturer producing a new drug in the country by a new
on business in a manner process developed through indigenous Research and Development
conspicuous part of the premises where he carries
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person wishing to consult the same. and patented under the Indian Patent Act, 1970 (process patent)
so as to be easily accessible to any
for a period of 5 years from the date of the commencement of its
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commercial production in the country;
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SCHEDULED & NON-SCHEDULED FORMULATIONS

(n a manufacturer producing a new drug involving a new delivery
sell any formulation to
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Sale prices of formulations : No person shall system developed through indigenous Research and Development
specified in current price list
any consumer at a price exceeding the price
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for a period of 5 years from the date of its market approval in

on label of the container or pack thereof, whichever is
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or price indicated India.
less. Provided that the provision of this paragraph shall apply only when a
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formulation at a price which

Nodealer shall sell loose quantity of.any document showing approval of such new drugs from Drugs Controller
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pro-rata price of the formulation,
exceeds the General (India) is produced before the Government.
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or dealer. not to refuse sale rules of drug

Manufacturer, distrihutorDrug and Cosmetics Act and the made
Subject to provisions of from sale or
manufaçturer or distributor shall withhold
thereunder (a) no
sufficient reasons, and
refuse to sell to a dealer any drug without good and
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Telegram - Study Pharmacy
116 PHARMACEUTICAL JURISPRUDENCE
Ch-7 DRUGS (PRICES cONTROL) ORDER, 2013
117

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Section: 6 Anti-infective Medicines
SCHEDULE-I 6.1: Anthelminthics
(National List of Essential Medicines, 2011)

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6.1.1: Intestinal Anthelminthics Albendazole, Piperazine
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Section: 1 - Anesthesia 6.1.2: Antifilarials iethylcarbamazine citrate

1.1 General Anesthetics and 0xygen Ether, Halothane with vaporizer,

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6.1.3: Antischistosomals and Antitrematode Medicines Praziquantel
Isoflurane, Ketamine Hydrochloride, Nitrous Oxide, Oxygen, Thio-
-

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pentone Sodium, Sevoflurane, Propofol 6.2: Antibacterials
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6.2.1: Beta lactam medicines

1.2 Local Anesthetics Bupivacaine Hydrochloride, Lignocaine Hydro- Amoxicillin, Ampicillin, Benzathine,
Benzylpenicillin, Cefotaxime, Ceftazidime, Ceftriaxone, Cephalexin,
chloride, Lignocaine Hydrochloride Adrenaline, EMLA cream

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Cloxacillin, Amoxicillin+Clavulinic acid, Cefixime
1.3 Preoperative Medication and Sedation for Short Term Procedures
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Atropine Sulphate, Diazepam, Midazolam, Morphine Sulphate, Pro-

6.2.2: Other antibacterials Amikacin, Azithromycin, Gprofloxacin Hy-
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drochloride, Co-Trimoxazole (Trimethoprim + Sulphamethoxazole),
methazine Doxycycline, Erythromycin Estolate, Gentamicin, Metronidazole, Ni-
Section: 2 Analgesics, Antipyretics, Nonsteroidal Anti-inflammatory Medi trofurantoin, Sulphadiazine, Vancomycin Hydrochloride
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cines, Medicines used to treat Gout and Disease Modifying Agents used in 6.2.3: Antileprosy medicines Clofazimine, Dapsone, Rifampicin
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Rheumatoid Disorders
Nonsteroidal Anti- 6.2.4: Antituberculosis medicines Ethambutol, Isoniazid, Ofloxacin,
2.1 Non-Opioid Analgesics, Antipyretics nd
Pyrazinamíde, Rifampicin, Streptomycin Sulphate
inflammatory Medicines Acetyl Salicylic Acid, Diclofenac, Ibuprofen,
6.3: Antifungal medicines Amphotericin B, Clotrimazole, Fluconazole,
Paracetamol
- Morphine Sulphate, Tramadol, Fentanyl Griseofulvin, Nystatin
2.2 Opioid Analgesics
6.4: Antiviral medicines
2.3 Medicines used to treat Gout Allopurinol, Colchicine
6.4.1: Antiherpes medicines Acyclovir
2.4 Disease inodifying agents used in Rheumatoid disorders Azathio-
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prine, Methotrexate, Sulfasalazine, Hydroxychloroquine phosphate, 6.4.2: Antiretroviral medicines
Leflunomide 6.4.2.1: Nucleoside reverse transcriptase inhibitors Didanosine,
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Lamivudine, Lamivudine + Nevirapine + Stavudine Lamivudine +
Section: 3 - Antiallergics and Medicines used in Anaphylaxis
Zidovudine, Stavudine, Zidovudine, Stavudine + Lamivudine,
Adrenaline Bitartrate, Chlorpheniramine Maleate, Dexchlorpheniramine Zidovudine + Lamivudine Nevirapine
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Maleate, Dexamethasone, Hydrocortisone Sodium Succinate, 6.4.2.2: Non-nucleoside reverse transcriptase inhibitors Efavirenz,
Pheniramine Maleate, Prednisolone, Promethazine, Cetrizine
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Nevirapine
Section: 4 Antidotes and Other Substances used in Poisoning
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6.4.2.3: Protease inhibitors Indinavir, Nelfinavir, Ritonavir, Saquinavir

4.1: Nonspecific Activated Charcoal 6.5: Antiprotozoal Medicines
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4.2: Specific Atropine Sulphate, Specific Antisnake venom, Calcium 6.5.1: Antiamoebic and Antigiardiasis medicines Diloxanide Furoate,
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gluconate, Desferrioxamine mesylate, Methylthioninium chloride Metronidazole

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(Methylene blue), Penicillamine, Dimercaprol, Flumazenil, Sodium 6.5.2: Antileishmaniasis medicines Amphotericin
Nitrite, Sodium Thiosulphate, Naloxone, Pralidoxime Chloride(2 B, Pentamidine
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Isothionate, Sodium Stibogluconate

PAM), N-acetylcysteine
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6.5.3: Antimalarial Medicines
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Section: 5- Anticonvulsants/Antiepileptics 6.5.3.1: For curative treatment Artesunate (To be used only in
Carbamazepine, Diazepam, Magnesium sulphate, Phenobarbitone, combination with Sulfadoxine + Pyrimethamine), Chloroquine phos-
Phenytoin Sodium, Sodium Valproate, Lorazepam phate, Primaquine, Pyrimethamine, Quinine sulphate, Sulfadoxine+
Pyrimethamine, Clindamycin
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118
PHARMACEUTICAL JURISPRUDENCE Ch-7 DRUG5 (PRICES CONTROL) ORDER, 2013 119

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Section: 12 Cardiovascular medicines
6.5.3.2: For prophylaxis Mefloquine 12.1: Antianginal medicines Acetyl salicylic acid, Diltiazem, Glyceryl
medicines Co

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6.5.4: Antipneumocystosis .and Antitoxoplasmosis Trinitrate, Isosorbide 5 Mononitrate/ Dinitrate, Metoprolol
Trimoxazole (Trimethoprim Sulphamethoxazole), Pentamidine
Clopidogrel
Isothionate

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12.2: Antiarrhythmic medicines - Adenosine, Amiodarone, Diltiazem,
Section: 7 Antimigraine medicines Esmolol, Lignocaine Hydrochloride, Procainamide Hydrochloride,

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Acetyl Salicylic Acid, Verapamil
7.1: For treatment of acute attack
-
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Dihydroergotamine, Paracetanol 12.3: Antihypertensive medicines- Amlodipine, Atenolol, Enalapril

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7.2: For Prophylaxis - Propranolol hydrochloride Maleate, Losartan Potassium, Methyldepa, Nifedipine, Sodium Nitro-
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prusside, Hydrochlorthiazide
Section: 8 Antineoplastic, immunosuppressives and medicines used in
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12.4: Medicines used in heart failure Digoxin, Dobutamine, Dopamine
palliative care Hydrochloride
Cyclosporine
8.1: Immunosuppressive medicines Azathioprine, 12.5: Antithrombotic medicines Acetyl salicylic acid, Heparin Sodium,
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D, Alpha Interferon, Bleomycin,
8.2: Cytotoxic medicines Actinomycin Streptokinase, Urokinase
Cytosine arabinoside,
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Cyclophosphamide,

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Busulphan, Cisplatin, Folinic 12.6 Hypolipidemic Medicines Atorvastatin
Danazol, Doxorubicin, Etoposide, Flutamide, 5-Fluorouracil,
hydrochloride, L- Asparaginase, Melphalan, Mer-
Acid, Gemcitabine Section: 13 Dermatological medicines (Topical)
Procarbazine,
captopurine, Methotrexate, Mitomycin-C, Paclitaxel, 13.1: Antifungal medicines Miconazole
Dacarbazine,
Vinblastine sulphate, Vincristine, Carboplatin, Chloram- 13.2: Antiinfective medicines- Acyclovir. Framycetin Sulphate,
Daunorubicin, Ifosfamide, Mesna, Oxaliplatin, Imatinib,
Methylrosanilinium Chloride (Gentian Violet), Neomycin + Baci-
bucil tracin, Povidone Todine, Silver Sulphadiazine
Raloxifene, Tamoxifen
8.3: Hormones and antihormones Prednisolone, 13.3: Antiinflammatory and antipruritic medicines Betamethasone,
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Citrate Dipropionate, Calamine
Sulphate, Ondansetron,
8.4: Medicines used in palliaive care Morphine 13.4: Astringent Medicines Zinc Oxide
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Filgrastim, Allopurinol
13.5: Medicines affecting skin differentiation and proliferation Coal
Section: 9 - Antiparkinsonism medicines Tar, Dithranol, Glycerin, Salicylic Acid
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Bromocriptine, Mesylate, Levodopa Carbidopa, Trihexyphenidyl
13.6: Scabicides and Pediculicides Benzyl benzoate, Permethrin
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Hydrochloride
Section: 14 Diagnostic agents
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Section: 10 Medicines affecting the blood 14.1: Ophthalmic medicines Fluorescein, Lignocaine, Tropicamide
Cyanocobalamin, Ferrous Sulphate/
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10.1: Antianaemia medicines
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Folic Acid, Iron Dextran, Pyridoxine 14.2: Radiocontrast media Barium Sulphate, Calcium Ipodate, Iopanoic
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Fumrate, Acid, Meglumine Iothalamate, Meglumine Iotroxate, Propyliodone,

affecting coagulation Heparin Sodium, Protamine
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10.2: Medicines Sodium Iothalamate, Sodium Meglumine, Diatrizoate
Warfarin sodium, Enoxaparin
Sulphate, Phytomenadione,
Section: 15 Disinfectants and antiseptics
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Section: 11 - Blood products and Plasma substitutes 15.1: Antiseptics Acrifilavin+Glycerin, Benzoin Compound, Cetrimide,
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Fresh frozen plasma,
11.1: Plasma Substitutes Dextran-40, Dextran-70, Chlorhexidine, Ethyl Alcohol 70%, Gentian Violet, Hydrogen Perox
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Hydroxyethyl Starçh (Hetastarch), Polygeline ide, Povidone Iodine

use Abumin, Cryoprecipitate, Factor
11.2: Plasma fractions for specific Factors I, VI, 15.2: Disinfectants Bleaching Powder, Formaldehyde Solution, Glutaral-
VIIL, Concentrate Factor IX Complex (Coagulation dehyde, Potassium Permanganate
IX, X), Platelet Rich Plasma
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120 PHARMACEUTICAL JURISPRUDENCE Ch-7 DRUGS (PRICES CONTROL) ORDER,
2013 121

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Section: 16 Diuretics Section: 19 Immunologicals
Furosemide, Hydrochlorothiazide, Mannitol Spironolactone 19.1: Diagnostic agents Tuberculin, P:urified Protein derivative

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Section: 17 Gastrointestinal medicines 19.2: Sera and immunoglobins Anti-D immunoglobin (human), Polyva-
lent Antisnake Venom, Antitetanus uman immunoglobin, Diphtheria
17.1: Antacids and other Antiulcer medicines Aluminium Hydroxide+

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Antitoxin, Rabies immunoglobin
Magnesium Hydroxide, Omeprazole, Ranitidine, Pantoprazole,
19.3: Vaccines

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Famotidine
omperidone, Metoclopramide, Promethazine, 19.3.1: For Universal Immunisation
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17.2: Antiemetics C.G. Vaccine, D.P.T Vaccine,

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Ondansetron Hepatitis B Vaccine, Measles Vaccine, Oral Poliomyelitis vaccine

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(LA)
17.3: Antiinflammatory Medicines 5-Amino salicylic Acid (5-ASA)
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19.3.2: For Specific Group of Individuals - Rabies Vaccine, Tetanus

17.4: Antispasmodic medicines Dicyclomine Hydrochloride, Hyoscine
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Toxoid
Butyl Bromide
17.5: Laxatives Bisacodyl, Ispaghula Section: 20 Muscle Relaxants (Peripherally acting) and Cholinesterase
Inhibitors
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17.6: Medicines used in diarrhorea
Atracurium besylate, Neostigmine, Pyridostigmine, Succinyl choline
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17.6.1 Oral dehydration salts Oral Rehydration Salts
chloride, Vecuronium
17.6.2 Antidiarrhoeal medicines Zinc Sulfate
Section: 21 Ophthalmological Preparations
Section: 18 - Hormones, other endocrine medicines and contraceptives 21.1: Anti-infective agents Ch loramphenicol, Ciprofloxacin Hydrochlo-
18.1: Adrenal hormones and synthetic substitutes Dexamethasone, ride, Gentamicin, Miconazole, Povidone Iodine, Sulphacetamide
Hydrocortisone, Sodium Succinate, Methyl Prednisolone, Prednisolone Sodium
18.2: Androgens Testosterone 21.2: Antiinflammaory agents Prednisolone Acetate, Prednisolone So-
18.3: Contraceptives dium Phosphate
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18.3.1: Hormonal Contraceptives Ethinylestradiol + Levonorgesterol, 21.3: Local Anaesthetics Tetracaine Hydrochloride
Ethinylestradiol + Norethisterone, Hormone Releasing IUD 21.4: Miotics and Antiglucoma medicines - Acetazolamide, Betaxolol
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18.3.2: Intrauterine devices- IUD containing Copper Hydrochloride, Pilocarpine, Timolol Maleate
18.3.3: Barier Methods- -Condoms 21.5: Mydriatics Atropine Sulphate, Homatropine, Phenylephrine
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18.4: Estrogens- -Ethinylestradiol 21.6: Ophthalmic Surgicl Aids Methyl Cellulose
-
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18.5: Medicines used in Diabetes mellitus Section: 22 Oxytocics and Antioxytocics
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18.5.1: Insulins and other Antidiabetic agents Glibenclamide, Insutin 22.1:Oxytocics Methyl Ergometrine, Mifepristone, Oxytocin, Misoprostoi
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Injection (Soluble), Intermediate Acting(Lente/NPH Insulin), 22.2: Antioxytocics Terbutaline Sulphate, Nifedipine, Betamethasone
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Metformin, Premix Insulin 30:70 Injection

Section: 23 Peritoneal Dialysis Solution
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18.5.2 Medicines used to treat hypoglycemia lucagon, 25% Dextrose
18.6 Ovulation Inducers Clomiphene citrate Intraperitoneal Dialysis Solution
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18.7 Progestogens Medroxy Progesterone Acetate, Norethisterone Section: 24 Psychotherapeutic Medicines

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18.8 Thyroid and antihyroid medicines Carbimazole, Levothyroxine, 24.1: Medicines used in Psychotic Disorders - Chlorpromazine hydrochlo-
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Iodine ride, Haloperidol, Olanzapine

24.2: Medicines used in mood disorders
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122

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Amitriptyline, Fluoxetine
24.2.1: Medicines used in Depressive disorders

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hydrochloride, Imipramine
- Lithium Carbonate, Sodium
24.2.2: Medicines used in Bipolar disorders

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Valproate
24.3: Medicines used for Generalized
Anxiety and Sleep Disorders

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Alprazolam, Diazepam
Poisons Act
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disorders and panic

24.4: Medicines used for obsessive compulsive

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attacks Fluoxetine hydrochloride
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Section: 25 Medicines acting on the respiratory tract Introduction Certain drugs and chemicals may be poisonous to human
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Beclomethasone Dipropionate, Hydro-
25.1: Antiasthmatic medicines
-
beings and animals. A pharmacist has to exercise extra care in dealing with
cortisone sodium succinate, Salbutamol sulphate, Ipratropium
poisons, particularly in dispensing practice.
bromide Poisons Act was passed on 3rd September 1919 with the object of
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25.2: Antitussives Codeine phosphate, Dextromethorphan consolidating and amending the laws regulating the import, possession and
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distur-
Section: 26 Solutions correcting water, electrolyte and acid-base sale of poisons. The Act was passed with the object of tightening the
control over traffic in poisons.
bances
Oral Rehydration Salts Poisons Act extends to the whole of India but in the State of Jammu
26.1: Oral -

with sodium chloride, Normal Saline, and Kashmir the provisions relating only to importation of specified
26.2: Parenteral Glucose, Glucose Ringer Lactate, Sodium poisons are applicable.
N/2 Saline, N/5 Saline, Potassium Chloride,
The term poison has not been defined in the Act but includes those
Bicarbonate substances specified as poisons. In general, poison is a substance that can
Water for Injection
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26.3: Miscellaneous cause death or serious illness if you eat it, drink it etc.
Section: 27 Vitamins and Minerals The Act empowers the Central Government to regulate the import of
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(As per Schedule V poisons into India. Rules regarding possession and sale of poisons within a
Ascorbic Acid, Calcium carbonate, Multivitamins Ribofla-
Nicotinamide, Pyridoxine, State are to be framed by various State Governments.
of Drugs and Cosmetics Rules),
Vitamin D (Ergocalciferol), Calcium
vin, Thiamine, Vitamin A,
Import of poisons Import of any specified poison into India may be
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gluconate prohibited by Central Government but it can make rules and allow such
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import under a licence.
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Possession and sale of poisons State Governments may make rules to

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regulate the possession and sale of any specified poison within whole or
part of the State. These rules may provide for-
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1. grant of licences to possess any specified poison for wholesale or

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retail and fixing of licence fee;
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2. lasses of persons to whom such licences can be granted and to

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whom such poisons may be sold;
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3. maximum quantity of a poison which may be sold to any one.

person;
4. safe custody of such poison and labeting of vessels, packages or
coverings in which such poison is sold or kept for sale;
123
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124 Pharmacy PHARMACEUTICAL JURISPRUDENCE

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5. maintenance of sales registers and their inspection; and
6. inspection and examination of any such poison when possessed for

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sale by any vendor.
State Govermments may also make rules to regulate possession of any
specified poison in any local area in which such poison is frequently used

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in committing murder or poisoning the cattle. State Governments can also

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make breach of such rule punishable with imprisonment upto one year or
Medicinal and Toilet Preparations
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fine upto 7 1000 or both; together with confiscation of poison in respect

of which the breach has been committed, and of vessels, packages, or (Excise Duties) Act

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coverings which it is found.
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Penalties Import, possession or sale of any poison, except as pre-

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scribed under the Act is punishable with imprisonment upto 3 months or
Introduction To the general public, alcohol signifies an euphoric drink
fine upto 500 or both on first conviction; and on subsequent conviction, and it has acquired this status since time immemorial. However consump-
imprisonment upto 6 months or fine upto 1000 or both.. Poison, in
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tion of alcohol for drinking purpose to derive pleasure is the abuse of this
respect which an offence has been committed, together with the vessels,
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liquid. It is also employed in the manufacture of toilet preparations, which
packages or coverings in which the poison is found, can also be confis- can, at the best be considered a luxury.
cated.
Alcohol is widely used in the manufacture of drugs, medicines anc
Issue of warrants District Magistrate, Sub-Divisional Magistrate or toilet preparations on accoulnt of its excellent solvent properties and
Commissioner of Police may issue a warrant for the search of any place in preservation action. It also attracts excise duty. Before this Act was
which he has reason to believe that any poison is possessed or sold in passed there existed differences in the excise duty on preparations contain-
contravention of the Act or any poison liable to confiscation under the Act ing alcohol in different States. This resulted in a large scale inter-State
is kept or concealed. smuggling of such preparations. Medicinal and Toilet Preparations (Excise
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Rules State Governments may make additional rules to carry out the Duties) Act was passed in 1955 to overcome this problem and fix uniform
purposes and objects of this Act. These rules should be published in the excise duty on medicinal and toilet preparations.
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Official Gazette. Act extends to the whole of India and came into force on 1st April,
Savings Nothing in the Act applies to anything done in good faith in 1957
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the exercise of his profession by a medical or veterinary practitioner. The
authorities empowered to make rules under the Act, may exempt any class
Definitions
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of persons, either partially or wholly, from the scope of the rules, in alcohol means ethyl alcohol of any strength and purity having the chemical
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respect of any poisons specified in such Order. composition CzHsOH;

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State Governments may also exempt any articles of commerce or any dutiable goods means the medicinal and toilet preparations specified in
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poison or class of poisons from any of the provisions of this Act (except the Schedule as being subject to the duties of excise levied under the
Act;
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import).
medicinal preparation includes all drugs which are a remedy or prescrip-
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tion prepared for internal or external use of human beings or animals

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and all substances intended to be used for or in the treatment,
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nitigation or prevention of disease in human beings or animals;

narcotic drug or narcotic means a substance which is coca leaf, or coca
derivative or opium or derivative of opium, or Indian hemp and shall
include any other substance capable of causing or producing in human

125
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which the standard preparation means a preparation other than a "sub-standard'
beings dependence, tolerance, and withdrawal syndromes and
declare preparation;
Central Government may by notification in the Official Gazette,

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to be narcotic drug or narcoic; warehouse means any place or premises licensed under rule 70.
for use in the
toilet preparation means any preparation which is intended

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human body or in perfuming apparel of any description, or LICENSING
toilet of the
complexion,

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any substance intended to cteanse, improve, or alter the Alcoholic preparations, narcotics or narcotic drugs can be manufactured
hair, skin, or teeth, and includes deodorants and perfumes;
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only under the authority of a ticence. Such licence can be issued only if
means alcohol conforming to the British Pharmacopæial requisite licence for manufacture of drugs under Drugs and Cosmetics Act

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absolute alcohol
specifications for dehydrated alcohol; has been first obtained. The licence can't be sold or transferred and it
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and licensed for the must be exhibited in a conspicuous part of the licensed premises.
bonded manufactory means the premises approved
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manufacture and storage of medicinal and toilet preparations
containing
Indian hemp or other narcotic drug on which duty has MANUFACTURE
alcohol, opium,
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not been paid; Manufacture of medicinal and toilet preparations containing alcohol is
licensed for
non-bonded manufactory means the premises approved and preparations
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permitted in bond without payment of duty as well as outside bond. In
manufacture and storage of medicinal and toilet case of the manufacture in bond, alcohol (on which excise duty has not
the
containing alcohol, opium, Indian hemp and other narcotic drugor been paid) is to be used under excise supervision; and in case of
narcotics on which duty has been paid; manufacture outside bond, duty paid alcohol only has to be used.
alcohol of any strength
denatured alcohol or denatured spirit means by the addition A. Manufacture in Bond
which has been rendered unfit for human consumption
Government or by the State If manufacturer enters into a bond with sufficient security for payment
of substances approved by the Central of duty, he can obtain rectified spirit without prior payment of duty.
Government with approval of the Central Government;
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not less Bonded manufactory should have only one entrance and one door to
rectified spirit means plain undenatured alcohol of strength
a
absolute alcohol each of its compartments. Al doors should be secured with excise ticket
than 50.0° over proof and includes
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locks during the absence of the officer-in-charge.
preparation speci
restricted preparation means every medicinal and toilet A bonded laboratory should provide for the following-
schedule and includes every preparation declared by the
fied in the
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preparation; 1. one plain spirit store unless manufactory is attached to a distillery
Central Government as restricted
preparation con- or a spirit warehouse,
unrestricted preparation means any medicinal or toilet or a spurious
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other than restricted preparation 2. at least one large room for manufacturing medicinal preparations
alcohol bu
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taining
and separate arrangement for manufacture of toilet preparations,
preparation;
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non-bonded manufactory 3. room(s) for storing finished medicinal preparations and for storage
spirit store means that portion of the bonded or
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Indian hemp and of finished toilet preparations,

which is set apart for the storage of alcohol, opium,
or at prescribed
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narcotics purchased free of duty 4. accommodation with necessary furniture for officer-in-charge in the
other narcotic drugs or
bonded premises,
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rates of duty:
preparation in which the 5. malleable iron rods not less than 3/4" in thickness, set not more
sub-standard preparation is (a) a pharmaceutical
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amount of any of the various ingredients is. below the minimum that than 4" apart, embodied in brick work upon a depth of at least two
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would. require; or (6) a proprietary inches and covered on the inside with strong wire netting or
the Pharma opa al composition test of
medicine which does not conform to the formula or the expanded metal of a mesh not exceeding one inch in diameter or
label on the container or on the container; length in every window of the bonded premises,
ingredients disclosed on the
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128 Pharmacy PHARMACEUTICAL JURISPRUDENCE
Ch-9 MEDICINAL AND TOILET PREPARATIONS
(EXCISE DUTIES) ACT
129

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6. a board on which name of the room and a serial number, if any, Manufacturer should inform the Excise
Commissioner the names of all
are legibly paínted in oil colour, on the outside of every such room employees required to enter non-bonded manufactory.

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No other person can
in the manufactory, enter the manufactory without special per-mission of
or wash basins inside manufactory premises proper officer.
7. all pipes from sinks Excise Commissioner and other officers
discharginginto drains forming part of the general drainage system having jurisdiction over the area

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in which manufactory is situated,
any authorized officer of the prohibition,
of the premises, land revenue, medical and public health
department; can inspect the non-

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8. all gas and electrical connections with the licensed premises so bonded manufactory at all reasonable times.
Proper officer should inspect
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fixed as to admit of the supply of gas or electricity being cut ofF the non-bonded manufactory at least once
every month.
and all the regulators or switches being securely locked at the end

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of the day's work. Inter-State Transport of Alcoholic Goods
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Addition or alteration in respect of permanent fixture in the bonded Medicinal and toilet preparations
containing
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hemp or other narcotic drugs can be moved from alcohol, ópium, Indian
premises can be made only with previous permission of Excise Commis-
sioner. Permanent vessels for storage of alcohol, narcotic drugs and
after payment of duty. They may however be one State to another only
a bonded warehouse in one State to a transferred under bond from
narcotics received under bond and all finished preparations on which duty
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warehouse in other State, without
payment of duty.
has not been paid should be secured with excise ticket locks. Al vessels
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intended to hold alcohol and liquid preparations should bear a distinctive
serial number and their full capacity distinctly and indelibly marked on OFFENCES AND PENALTIES
them. Offence
Rectified spirit required for the manufacture of medicinal and toilet Penalty
(i) Non-compliance with conditions
preparations can be obtained on an indent countersigned by officer-in- Imprisonment upto 6 months
of license and failure to pay duty; or
charge, from any distillery or spirit warehouse. Consignments of spirit or fine upto R 200 or both
(ii) Failure to supply information
received under bond have to be verified in volume and strength at bonded -do-
asked, or supplying false
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laboratory and then stored in the spirit store. Calculated quantity of inform ation; o
alcohol can be obtained on a requisition by licensee to the officer-in- (iii) Attempting or committingor
charge. As soon as a preparation is manufactured, it should be removed to
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abetting commission of any offence -do-
the finished goods store. It has to be stored in jars or bottles each (iv) Connivance of offences by owners
containing not less than 80 fluid ounce volumes. or occupiers of land,
Imprisonment upto 6 months
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or fine upto { 500 or both
Alcoholic preparations from a bonded laboratory can be taken out by (v) Vexatious search, seizure etc.
Fine upto 2000 for every
manufacturer by making an application to the officer-in-charge after
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by Excise Officer
offence
payment of duty. Duty is also to be paid even on physician's free samples. (vi) Failure of Excise Officer
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Imprisonment upto 3 months or

Preparations issued to boded warehouse or for export or to institutions on duty
fine upto 3 months pay or both
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entitled to receive duty-free preparations, may be issued without payment Improper keeping of stocks or accounts
Fine upto R 100
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of duty. Making false entries or tearing

Fine upto 2000 and goods
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pages from stock book
B.Manufacture
Manufacture Outside Bond i
Sale of dutiable goods otherwise
liable to confiscation
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and sale in a non-bonded laboratory has to be conducted than in Fine upto 7 1000 and goods
prescribed containers bearing the labels
between sunrise and sunset on days and: hours fixed by Excise Commis-
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liable to confiscation
Failure to furnish proof of export
sioner. There should be ai'spirit store, a 'laboratory and a finished store
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Fine upto 7 2000

within specified period
each having one door and only one entrance to the laboratory. Construc
tion of windows of the 'spirit store', laboratory' and 'finished store' etc. are
similar to bonded manufactory. .Continued
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Study Pharmacy PHARMACEUTICAL JURISPRUDENCE Ch-9 MEDICINAL AND TOILET PREPARATIONS (EXCISE DUTIES)
ACT
131

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Penalty
Provision and maintenance of weighing and measuring apparatus
Offence Every licensed dealer in dutiable goods should provide sufficient

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and just
scale and weights, or a corect weighing machine and a standard measure
offences with respect to warehousing
Fine uptoR 2000 and goods and instruments for purpose of weighing, measuring, gauging, proving and
(i) Opening any locks or door of
taking an account, of goods in his warehouse. The weights, measures,

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warehouse without prior consent; or liable to confiscation
-do gauging and proving instruments shall be of denominations as specified by
(i) Making any alteration in warehouse

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without prior consent; or the Excise Commissioner. These should be maintained by the
dealer in
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-do such proper and convenient place within the licensed premises approved by
(i) Warehousing or removing goods
the excise officer so as to be available at all times ready for use of officers.

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in contravention of the rules; or
(iv) Privately removing or concealing
Refusal or neglect on the part of the licensee to comply with
,
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these
any goods either before or after provisions shall make him tiable to a penalty extending to 1000.
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being warehoused; Provision and maintenance of locks Where any licensed premises is
(v)Obstructing the officers and Fine upto 500
directed to be secured and locked, the licensee should provide, affix, repair
giving false information;
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and renew all fastenings necessary for securing and locking the place, to
(vi) wilfully and maticiously giving false Imprisonment upto 2 years or
the satisfaction of the proper officer. If the licensee fails to do so, the
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information and causing arrest; fine upto 2000 or both.
proper officer may provide, affix, repair or renew the fastenings
(vii) Disclosure of information by Fine upto 1000 and the
expenses may be demanded from the licensee. If the licensee fails to pay
Excise Officers.
on demand such expenses or if he or his servant or workman wiltfully
Breach of any rule where no Fine upto 7 1000 and goods
destroys or damages any such fastenings or any lock, label etc., the
penalty is provided liable to confiscation
licensee shall be liable to a penalty which may extend to 2000.
Goods, plant, machinery charged with duty not paid Excise Commis-
MISCELLANEOUS sioner may detain any machinery, plants, goods, vesseis, utensils and
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Officers required to assist each other All officers of customs, central implements etc. in tieu of duty that may be due to the government until
excise, police, land revenue, and such other officers as may be specified by such duties are paid; and such directive shall have effect notwithstanding
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the Central Government are required to assist each other in the execution any change in the ownership of the trade or business.
of the Act. List of medicinal and toilet preparations containing alcohol, which are
Bar of suits and timitation of suits and other legal proceedings No capable of being consumed as ordinary alcohol beverages is provided in
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suit or other legal proceeding shall lie against the colecting government or Schedule to Rules
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against any officer in respect of any order passed in good faith or any act
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done in good faith or ordered to be done under this Act. No suit or other
legal proceeding can be instituted against the collecting government or
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against any officer for anything done or ordered to be done under this Act,
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after the expiry of six months from the actual date of the cause of action.
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Excise officers State Governments may appoint desired number of
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excise officers to carry out the provisions of the Act and Rules. Excise
Commissioner may perform any or all the duties delegated to the excise
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officer, under the Act. He may authorize any officer under his control to
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carry out any of'te furkctions assigned to him under the Act for any area
specified by him.
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Insta - Study_Pharmacy_29
Telegram - Study Pharmacy Ch-10 MEDICAL TERMINATION OF PREGNANCY ACT

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133
registered medical practitioner means a person who possesses any recog
nized medical qualification as defined under the Indian Medical Council

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10 Act and whose name has been entered in a State Medical Register
who has such experience or training in gynaecology and
and
obstetrics as

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may be prescribed by rules made under this Act;

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Chief Medical Officer of the District means the Chief Medical Officer
Medical Termination of Pregnancy Act district, by whatever name called;
ofa
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hospital means a hospital established and maintained by

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the Central
Government or the Government of the Union Territory:
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Introduction The population of India in 2020 is expected to be 1175 admission register means the register maintained under Regulation 5;
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and 1331 millions, as against 1027 millions in 2001. Every Government is
approved place means a place approved under Rule 4 of the MTP Rules,
concerned with the public health. Central as well as State governments
1975.
have implemented several family welfare measures.
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mentally ill person means a person who is in need of treatment by
The concept of small and planned family is gaining popularity and the reason
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of any mental disorder other than mental retardation;
public awareness is increasing gradually. In spite of these efforts the
population of India is increasing at an alarming rate. Equally important owner in relation to a place means any person who is the administrative
concern is that there are large numbers of cases of unwanted or medically head or otherwise responsible for the working or maintenance a
undesirable pregnancies. Pregnancy occurring due to the rape of a woman hospital or place, by whatever name called, where the pregnancy of
may
is one such example. The Medical Termination of Pregnancy Act, 1971 and be terminated under this Act;
the Rules provide for the termination of certain pregnancies by registered place means such building, tent, vehicle or vessel, or part thereof as
medical practitioner (RMPs), and related matters. This was required because for the establishment or maintenance thereat used
were terminated by unauthorized of a hospital or ctinic
in absence of such legislation, pregnancies which is used, or intended to be used, for the termination
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and unqualified persons, endangering the life of gnant women. of any
pregnancy.
Termination of pregnancy is not something which is provided for the
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Termination of pregnancies A pregnancy may be terminated by a
first time by the Medical Termination of Pregnancy Act. Section 312 of the under following conditions
RMP
Indian Penal Code too protects termination of pregnancy described as When the length of pregnancy does When the length of pregnancy
miscarriage; if it is done "in good faith for the purpose of saving the life ex
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not exceed 12 weeks and the RMP is ceeds 12 weeks but does not exceed
of the woman". Similarly Section 315 of the Indian Penal Code protects any of the opinion that
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aut done with intent to prevent child from being born alive or causing it to 20 weeks and if not less than two
RMPs are of the opinion
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die after its birth "if such act has been done in good faith for the purpose that
(i) the continuance of the pregnancy would involve
of saving the life of the mother". a serious risk to
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the life of the pregnant woman or cause grave injury
The Act extends to the whole of India except the State of Jammu and to her
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physical or mental health; or

Kashmir.
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() there is a substantial risk that if the child were
bom, it would
Definitions suffer from such physical or mental abnormalities as
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to be seriously
guardian means a person having the care of the person of a minor or a handicapped.
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mentally ill person; This does not apply when a RMP is of the
opinion that termination of
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lunatic has the meaníng.assigned to it in section 3 of the Indian Lunacy

FU prgnancy is immediately necessary to save the life
of the pregnant
Act; woman.
Where any pregnancy is alleged by the pregnant woman
minor means a person who under the provisions of the Indian Majority Act, to have been
is to be deemed not to. have attained majority;
caused by rape, the anguish caused by such pregnancy shall be
to constitute grave injury to the mental health of
presumed
132 the pregnant woman.
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Insta - Study_Pharmacy_29 ,
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JURISPRUDENCE

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PHARMACEUTICAL
134
() anaesthetic equipment, resuscitation equipment and sterilization
Where any pregnancy occurs as a result of failure of any device or

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equipment
method used by any married
woman or her .husband for the purpose of emergency use are available.
by such unwanted (ii) drugs and parenteral fuids for
imiting the number of children, the anguish caused
After considering the application and recommendations of the Chief

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injury to the mental
pregnancy, may be presumed to constitute a grave
Medical Officer of the District, the Government may approve such place and
health of the pregnant woman.

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been justified under issue a certificate of approval. The certificate must be conspicuously
Under the Act termination of pregnancy has
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measure- when there is danger to the displayed at the place so that it is easily visible to persons visiting the
following conditions (i) as a health place.
woman; (ii) on humanitarian

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life or risk to physical or mental health of the
from a sex crime like rape or Experience/Training of RMP Any RMP having the following experience
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grounds- such as when pregnancy arises

lunatic woman, etc., and (ii) eugenic grounds- where in the practice of gynaecology and obstetrics can terminate the pregnancy
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intercourse with a
would suffer from deformi- under the Act
there is substantial risk that the child, if born,
ties and diseases. (a) If he was registered in a State Medical Register immediately before
without the consent of the pregnant commencement of the Act, and had experience in the practice of
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No pregnancy shall be terminated
woman is less than 18 years of age; gynaecology and obstetrics for not less than three 3 years.
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Woman except when (a) the pregnant woman
or (6) without the written consent of the
guardian if the pregnant (6) In the case of a RMP who was registered in a State Medical
person lunatic although she.has attained the age of 18
is mentally retarded Register on or after the date of commencement of this Act
years. (if he has completed six 6 months of house surgery in 9ynae
No pregnancy shall be terminated at
any place other than (a) a hospital cology and obstetrics; or
a place approved by the (i) vwhen if he has not done any such house surgery but, if he had
established or maintained by Government; or (b)
Government for this purpose. experience at any hospital for not less than one 1 year in the
a RMP is an offence. practice of gynaecology and obstetrics; or
Termination of pregnancy by a person other than
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lie against any RMP terminating a (ii) if he has assisted another RMP in the performance of twenty
No suit or other legal remedy shall
anything done in good faith. five cases of medical termination of pregnancy.
pregnancy, for any damage caused by
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This training would enable the RMP to do only 1st trirnester
may be terminateed Under the Act pregnancy
Pace where pregnancy Govern terminations (upto 12 weeks of gestation). For terminations up to
can be terminated at (a) a hospital established or maintained by 25 weeks the experience or training (a) and (b) above shall apply.
purpose of this Act
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being approved for the
ment, or (6) a place for the time (c) In the case of a medical practitioner who has been registered in a
Committee constituted by the Government.
by Government/a District Level
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State Medical Register and who holds a post-graduate degree or
pregnancy can be done by
a
Approval of place: Medical termina on of rics, the experience or training
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diploma in gynaecology. and ob:

a RMP only at an approved place.
Application for approval of a place gained during the course of degree or diploma.
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Chief Medical Officer of the District who shall
should be addressed to the Approval of place Medical termination of pregnancy can be done by a
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verify or inspect such place with a

view to ascertain himself that termina-
hygienic condition; and the RMP only at an approved place. The application for the approval of place
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tion of pregnancies can be done therein under
should be addressed to the Chief Medical Officer of the District who shall
following facilities are provided:-
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a inspect such place to ascertain himself that the following conditions are
up to 12 weeks of pregnancy
In case of first trimester (i.e. satisfied
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resuscitation and sterilization equip-
gynecolog9y examination/labour table, ) an operation table and instruments for performing abdominal or
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ment, drugs and parenteral fl ids, back up

facilities for treatment of shock
gynaecological surgery are available.
and
and facilities for transpoitatiün etc;
(i.e. upto 20 weeks of pregnancy) (i) anaesthetic equipment, resuscitation equipment and steilization
In case of second trimester equipment are available.
for performing abdominal or
) an operation table and instruments () drugs and parenteral fluids for emergency use are available.
gynaecological surgery;
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136 Pharmacy PHARMACEUTICAL JURISPRUDENCE

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The certificate of approval can be cancelled or suspended if the
prescribed facilities are not mintained and termination of pregnancy at

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such place cannot be made under safe and hygienic conditions.
Admission register Every head of the hospital or owner of approved
11
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place shal maintain a register for recording the admissions of woman for
the termination of pregnancies. The entries in the register shall be made

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serialy year wise e.g. 77/14 refers to serial number 77 of 2014. The Consumer Protection Act
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admission register shall be secret document and the information contained

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therein about the pregnant woman shall not be disclosed to any person.
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In case of an employed woman whose pregnancy has been terminated, the

RMP can grant a certificate on demand for the purpose of enabling her to Consumer Protection Act is important to pharmacists because according
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obtain leave from the employer. In order to promote family planning to the Supreme Court medical services are covered under the definition of
measure various States and Central Government grant leave to the woman service that includes rendering of consultation, diagnosis and treatment,
both medical and surgical.
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employees for medical termination of pregnancy. The employer, however,
is duty-bound not to disclose this information to any other person.
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Object To provide for better protection of the interests of consumers
No entry shall be made in any case sheet, operation theatre register, by establishment of consumer councils and other authorities
for the
follow up card or any other document or register except the admission settlement of consumers' disputes and matters connected therewith.
register maintained at any hospital or appròved place regarding the medical Consumer Protection Act came into force on 24 December, 1986 and
termination of pregnancy of a woman. Evey admission register shall be extends to the whole of India except the State of Jammu and Kashmir.
destroyed on the expiry of a period of five 5 years from the date of last entry
in that register. Other papers shall be destroyed on the expiry of a period of Definitions
three 3 years from the date of the termination of the pregnancy concerned. complaint means any allegation in writing made by a complainant that
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Custody of forms The consent given by a pregnant woman for the () an unfair trade practice or a restrictive trade practice has been
termination of pregnancy together with the certified opinion shall be adopted by any trader or service provider
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placed in an envelope which shall be sealed by the RMP and marked
"SECRET". The serial number assigned to the pregnant woman shall also be
(i) the goods bought by him or agreed to be bought by him suffer
from one or more defects;
entered on the envelope. Such envelopes shall be kept in safe custcdy by
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the head of the hospital or owner of the approved place. (ii) the services hired or availed of or agreed to be hired or availed of
by him suffer from deficiency in any respect;
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Rules and regulations The Central Government may make rules to (iv) a trader or the service provider has charged for the
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carry out the provisions of this Act to provide for the experience or goods or for
the services mentioned in the complaint, a price in excess of the
training or both which a RMP shall have if he intends to terminate any
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price (a) fixed by or under any law for the time being in force;
pregnancy under this Act; and other related matters.
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(6) or displayed on the goods or any package

The State Government may make regulation to provide for the containing such
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goods; (c) displayed on the price list exhibited by him by or
() taking of opinion, its certification by .RMP etc. and the preservation or under
any law; (d) agreed between the parties;
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disposal of such certificates; ) requiring any RMP who terminates a (V) goods which will be hazardous
pregnancy, to give intimation of such termination and such other informa- to life and safety when used, are
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being offered for sale to the public (a) in contravention
tion relating to the termination as may bè specified; and (i) prohibiting of the
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the disclosure of intimations given or information furnished in pursuance PEvisions of any standard relating to safety of such goods as
required to be complied with, by or under any law in force; (6)
of regulations to any unauthorisedunauthorized person. if
the trader could have known with due diligence that the goods so
offered are unsafe to the public;

137
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Ch-11 CoNSUMER PROTECTION ACT
139

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138
hazardous to life and tion, entertainment, amusement or the purveying of news or other
(vi) services which are hazardous or likely to be
information, but does not include the rendering of any service free of

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by the service
safety of the public when used, are being offered
provider, which such person could have known with due diligence charge or under a contract of personal service;
to be injurious to life and safety: with a view to
obtaining any spurious goods and services mean such goods and services which are

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relief provided by or under this Act; claimed to be genuine but they are actually not so.

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Consumer means any person who, trader in relation to any goods means a person who sells or distributes
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been paid or any goods for sale and includes the manufacturer thereof, and where
)buys any goods for a consideration which orhas any system such goods are sold or distributed in package form, includes the packer

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under

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promised or partly paid and partly promised,
of deferred payment and includes any
user of such goods other thereof;
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consideration paid or
than the person who buys such goods for Following Consumer Dispute Redressal Agencies have been set up
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promised or partly paid or partly promised, or under any system of under the Act:
payment when such use is made with the approval of such
deferred
person who obtains such goods for (a) District Forum established by the State Government in each Dis-
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person, but does not include a
trict:
resale or for any commercial purpose; or
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consideration which has been (6) State tommission established by the State Govermment in the
(i) hires or avails of any services for a promised, or under any State; and
paid or promised or partly paid and partly
payment and includes any beneficiary of such (c) National Consumer Disputes Redressal Commission established by
system of deferred
of the services the Central Government.
services other than the person who hires or avails
for consideration paid or promised, or partly paid and partly District Forum, the State Commission or the National Commission shall1
promised, or under any system of deferred
payment, when such not admit a complaint unless it is filed within two years from the date on
first mentioned which the cause of action has arisen.
services are availed of with the approval of the
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person; Where a trader or a person against whom complaint is made or the
shortcoming in the quality, complainant fails or omits to comply with any order made by the District
defect means any fault, imperfection orwhich is required to be main-
Forum, the State Commission or the National Commission, as the case may
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quantity, potency, purity or, standard
tained by or under any law for the time being in
force or under any be, such trader or person or the complainant shall be punishable with
contract, express or implied, or as is claimed by the trader in any imprisonment for a term which shall not be less than 1 month but which
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manner whatsoever in relation to any goods; may extend to 3 years, or with fie which shall not be less than ? 2000
or inadequacy in but which may extend to. 10,000, or with both.
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deficiency means any fault, imperfection, shortcoming is required to be
performance which The provisions of this Act shalU be in addition to and not in derogation
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the quality, nature and manner of force or has been

maintained by or under any law for the time being in of the provisions of any other law for the time being in force.
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performed by a person in pursuance of a contract or No suit, prosecution or other legal proceedings shall lie against the
undertaken to be
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otherwise in relation to any service; members of the District Forum,. the State Commission or the National
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which requires a Commission or any officer or person acting under the direction of the
restrictive trade practice means any trade practice case may be,
any. goods or, as the District Forum, tne State Commission or the National Commission for
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consumer to buy, hire or avail of

services as a condition precedent for buying, hiring, or availing of other executing any order made by it or in respect of anything, which is in good
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goods or services; faith done or intended to be done by such member, officer or person under
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is made available to this Act or under any rule or order made thereunder.
service means senvice of any, iascri tion which facilities in connection
potential users and includes the provision of
banking, financing, insurance, transport, processing, supply of
with
construc-
electrical or other energy, board or lodging or both, housing
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Insta - Study_Pharmacy_29
Telegram - Study Pharmacy Ch-12 RIGHT TO INFORMATION ACT
141

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Chief Information Commissioner and Information Commissioner mean
the Chief Information Commissioner and Information Commissioner

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appointed under sub-section (3) of section 12;
12 competent authority means

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the Speaker in the case of the House of the People or the
Legislative Assembly of a State or a Union territory having such

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Right To Information Act Assembly and the Chairman in the case of the Council of States or
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Legislative Council of a State;

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the Chief Justice of India in the case of the Suprme Court;
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Introduction Right to information is guaranteed to every citizen of the Chief Justice of the High Court in the case of a High Court;
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India under section 3 of the Right To Information Act, 2005. This right is the President or the Governor, as the case may be, in the case of
a potent weapon in the hands of citizens to gain access to public records. other authorities established or constituted by or under the Consti-
It not only provides information but also fosters accountability and tution; the administrator appointed under article 239 of the
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transparency on the one hand and strengthens the demographic principles Constitution;
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of a polity on the-other. information means any material in any form, including records, docu-
Object of the Act is to provide for setting out the practical regime of ments, memos, e-mails, opinions, advices, press releases, circulars,
right to information for citizens to secure access to information under the orders, logbooks, contracts, reports, papers, samples, models, data
control of public authorities, in order to promote transparency and ac- material held in any electronic form and information relating to any
countability in the working of every public authority, the constitution of a private body which can be accessed by a public authority
under any
Central Information Commission and State Information Commissions and for other law for the tine being in force;
matters connected therewith or incidental thereto. record includes
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The Act was passed on 15th June., 2005 and extends to the whole of any document, manuscript and file;
India except the State of Jammu and, Kashmir. The Freedom of Information
any microfilm, microfiche and facsimile copy of a document;
Act, 2002 is hereby repealed.
.
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any reproduction of image or images embodied in such microfilm
Definitions (whether enlarged or not); and
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appropriate. Government means in relation to a public authority which is any other material produced by a computer or any other
device;
established, constituted, owned, controlled or substantially financed by right to information means the right to information accessible
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funds provided directly or indirectly- under this
Act which is held by or under the control of any public authority
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and
by the Central Government or the Union territory administration includes the right to
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-the Central Government; inspection of work, documents, records;
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by the State Government, -the State Government; taking notes, extracts or certified copies of documents or records;
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Central Information Commission means the Central Information Commis- taking certified samples of material;
sion constituted under sub-section (1) of section 12;
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obtaining information in the form of diskettes, floppies, tapes,

Central Pubic Information 0fficer means the Central Public Information
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video cassettes or in any other eled onic mode or
OFficer designated under sub-section (1) and includes a Central Assist- through print-
ou's were such information is stored in a computer or in any
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ant Public Information Officer designated as such under sub-section (2) other device;
of section 5;
State Information Commission means the State Information Commission
constituted under sub-section (1) of section 15;

140
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- Study Pharmacy PHARMACEUTICAL JURISPRUDENCE Ch-12 RIGHT TO INFORMATION ACT 143

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Commis- Information that May be Refused
State Chief Information Commissioner and State Information
sioner mean the State Chief Information Commissioner and the State Notwithstanding anything contained a this Act, there shall be no

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Information Commissioner appointed under sub-section (3) of section obligation to give any citizen,
15 (a) information, disclosure of which would prejudicialy affect the

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Public Information sovereignty and integrity of Indi", the security, strategic, scientific
State Public Information Offricer means the State
Officer designated under sub-section (1) and includes State Assistant
a or economic interests of the State, relation with foreign State or

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of
Public Information Officer designated as such under sub-section (2) lead to incitement of an offence;
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section 5; (b) information which has been expressly forbidden to be published by

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a request for any court of law or tribunal or the disclosure ,of which may
third party means a person other than the citizen making
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information and includes a public authority. constitute contempt of court;

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of Public Authorities (c) information, the disclosure of which would cause a breach of
Right to Information and 0bligations privilege of Parliament or the State Legislature;
Subject to the provisions of this Act, all citizens shall have the right to
(d) information including commercial confidence, trade secrets or intel-
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information. lectual property, the disclosure of which would harm the competitive
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Every public authority shall maintain all its records duly
catalogued and position of a third party, unless the competent authority is
a manner and form which facilitates right to information under satisfied that larger public interest warrants the disclosure of such
indexed in
be computerised
this Act and ensure that all records that are appropriate to of resources, information;
are, within a reasonable time and subject to availability (e) information available to a person in his fiduciary relationship.
country on
computerized and connected through a network all over the unless the competent authority is satisfied that the larger public
different systems so that access to such records is facititated
interest warrants the disclosure of such information;
of the enactment
Every public authority shall, within one hundred days (information received in confidence from foreign Government;
many officers as the Central Public Information
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of this Act, designate as (g)information, the disclosure of which would endanger the life or
case may be, in all
Officers or State Public Information 0fficers, as the physical safety of any person or identify the source of information
to provide
administrative units or offices under it as may be necessary or assistance given in confidence for law enforcement or security
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information to persons requesting for the information under thís Act.
purposes;
A person, who desires to obtain any information under this Act, shall
(h) information which would impede the process of investigation or
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in English or Hindi
make a request in writing or through electronic means apprehension or prosecution of offenders;
application is being
or in the official language of the area in which the
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fee as may be prescribed, to- () cabinet papers including records of deliberations of the Council of
made, accompanying such
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Public Information Ministers, Secretaries and other officers:

(a) the Central Public Införmation Officer or State () information which relates to personal information the disclosure of
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Officer, as the case may be, of the concerned public authority; which has no relationship to any public activity or interest, or
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or State Assistant
(6) the Central Assistant Public Information Officer which would cause unwarranted invasion of the privacy of the
Public Information Officer, as the case may be, specifying the
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individual unless the Central Public Information Officer or the State
particulars of the information sought by him or her. Public Information Officer or the appellate authority, as the case
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An applicant making request for information shall

not be required to may be, is satisfied that the larger public interest justifies the
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reason for requesting the information or any other personal details disclosure of such information:
give any
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except those that may be necessary for, cntacting him. Provided that the infomation which cannot be denied to the Parlia-
which it is
Information shall ordinarily be provided in the form in ment or a State Legislature shall not be denied to any person.
unless it would disproportionately divert the resources of the public
sought preservation of the
authority or would be detrimental to the safety or
record in question..
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144 PHARMACEUTICAL JURISPRUDENCE Ch-12 RIGHT TO INFORMATION ACT
145

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The general superintendence, direction and management of
Central Information Commission i the affairs
of State Information Commission shall vest in State Chief Information
The Central Government shall constitute a body to be known as the

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Commissioner who shall be assisted by the State Information Commissioners
Central Information Commission to exercise powers conferred on, and to and may exercise all such powers and do all such acts and things
perform functions assigned to, it under this Act. which
may be exercised or done by State Information Commission autonomously

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The Central Information Commission shall consist of without being subjected to directions by any other authority under this
Act.

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(a) Chief Information Commissioner; and
State Chief Information Commissioner and State Information Commis-
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(6) such number of Central Information Commissioners, not exceeding

10, as may be deemed necessary. sioners shall be persons of eminence in public life with wide knowledge

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Chief Infom on Commissioner and Information Commis oners shal be and experience in law, science and technology, social service, management,
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appointed by the President on the recommendation of a committee

journalism, mass media or administration and governance.
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consisting of State Chief Information Commissioner or a State Information Commis-
() Prime Minister, who shall be the Chairperson of the committee; sioner 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
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(i) Leader of Opposition in the Lok Sabha; and other office
of profit or connected with any political party or carrying on any
business
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(i) a Union Cabinet Minister to be nominated by the Prime Minister. or pursuing any profession.
Chief Information Commissioner and Information Commissioners shall be Headquarters of State Information Commission shall be at such place
persons of eminence in public life with wide knowledge and experience in in
State as State Government may specify and State Information Commission
law, science and technology, social service, management, journalism, mass may, establish offices at other places in the State.
media or administration and governance. Any person who, does not receive a decision within
Headquarters of Central Information Commission shall be at Delhi and the time specified
in sub-section (1) or clause (a) of sub-section
(3) of section 7, or is
Central Information Commission may, with the previous approval of Central aggrieved by a decision of Central Public Information Officer or
State Public
Government, establish offices at other places in India.
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Information Officer, as the case may be, may within 30 days from the
expiry of such pernod or from receipt of such a decision prefer an
State Information Commission, } appeal to
such officer who is senior in rank to the Central Public Information
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Every State Government shall, by notification in the Official Gazette, Officer
or State Public Information Officer as the case may be, in
constitute a body to be known as the -..
each public
(name of the State) authority.
Information Commission to exercise powers conferred on, and to perform
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A second appeal against decision
functions assigned to, it under this Act. under sub-section (1) shalu lie within
90 days from the date on which the decision should have
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been made or
State Information Commision shall consist of was actually received, with the Central Information Commission
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or the State
(a) State Chief Information Commissioner, and Information Commission:
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(b) such number of State Information Commissioners, not exceeding9 If the decision of Central Public Information Officer or
State Public
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ten, as may be deemed necessary. Information Officer, as the case may be, against which an
appeal is
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State Chief Information Commissioner and State Information Commis preferred relates to information of a third party, the Central
Information
sioners shall be appointed by the Governór, on the recommendation of a Commission or State Information Commission, as the case may
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be, shall
committee consisting of give a reasonable opportunity of being heard to
that third party.
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-

)Chief Minister, who shall be the Chairperson of the committee: An appeal under sub-section (1) or sub-section
(2) shall be disposed of
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within 30 days ofi ti2 receipt of the appeal or within such extended
(i) Leader of Opposition. in the Legislative Assembly: and period
not exceeding a total of 45 days from the date of filing thereof,
(in) a Cabinet Minister to be nominated by the Chief Minister. as the
case may be,,for reasons to be recorded in writing.
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Information
The decision of Central Information Commission or State
Commission, as the case may be, shal be binding.

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Miscellaneous i APPENDIX
No' suit, prosecution or other legal proceeding shall lie against any

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person for anything which is in good faith done or intended to be done LIST OF ESsENTIAL MEDICINES

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under this Act or any rule made thereunder.
Essential medicines satisfy the priority health care needs of the popula-
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Provided that no such order shall be made after the expiry of a period tion. They are selected with due regard to public health relevance,
of 2 years from the date of commencement of this Act.

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evidence on efficacy and safety, and comparative cost-effectiveness. They
Every order made under this section shall, as soon as may be after it
is are intended to be available within the context of functioning health
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be laid before each House of Parliament. systems at all times in adequate amounts, in the appropriate dosage forms,
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made,
with assured quality and adequate information, and at a price the indi-
THE SECOND SCHEDULE vidual and the community can afford. An essential medicines list is a tool
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to focus the work and money of a government. It helps to focus priorities
Intelligence and security organizations established by the Central Gov for the pharmaceutical sector as a whole, allowing for a higher quality of
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emment. care, better management of medicines, and more cost-effective use of
Wing of the Cabinet
1. Intelligence Bureau, 2. Research and Analysis health resources. The Essential Medicines List aims to identify cost
Secretariat, 3. Directorate of Revenue Intelligence, 4. Central Economic effective medicines for priority conditions, together with the reasons for
Control
Intelligence Bureau, 5. Directorate of Enforcement, 6. Narcotics their inclusion, linked to evidence-based clinical guidelines and with
Bureau, 7. Aviation Research Centre, 8. Special Frontier Force, 9. order special emphasis on public health aspects and considerations of value of
Security Force, 10. Central Reserve Police Force, 11. Indo-Tibetan Border money
Guards,
Police, 12. Central Industrial Security Force, 13. National Security The knowledge of Essential Medicine List is important to pharmacists.
Branch (CID),
14. Assam Rifles, 15. Special Service Bureau, 16. Special
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In Indian context drugs are classified as essentiai commodity under the
Andaman and Nicobar, 17. The Crime Branch-C.I.D.- CB, Dadra d Nagar
.

Essential Commodities Act. The Drugs (Prices Control) 0rder, 2013 has been
Haveli, 18. Special Branch, Lakshadweep Poiice. passed undér the powers given to the Central Government by Section of 3
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* (section 24) [Nothing ontained in this Act shall apply to the the Essential Commodities Act, 1955. The objective of the Order is to
intelligence and security organizations specified in the Second Schedule, ensure equitable distribution of essential bulk drugs and to fix the
any information
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being organizations established by the Central Government or maximum retail prices of drug formulations.
fumished by such organizatiorns to that Government: The model list of Essential Medicines recommended by the World Health
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Provided that the information pertaining to the allegations of corruption Organization (WH0) is reproduced below.
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this sub-section]
and human rights violations shall not be excluded under
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WHO MODEL LIST OF ESSENTIAL MEDICINES (MARCH 2010)
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abacavir (ABC), acetazolamide, acetic acid, acetylcysteine, acetylsali

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cylic acid, acyclovîr, albendazole, alcuronium, allopurinol, aluminium
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diacetate, aluminium hydroxide amidotrizoate, amikacin, amiloride,

amiodarone, amitriptyline, amlodipine, amodiaquine, amoxicillin, amoxicillin
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+ clavulanic atid, amphotericin B, ampicilin, anti-D immunoglobulin
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(human), antitetanus immunoglobulin (human), antivenom immunoglobu-

lin, artemether, artemether lumefantrine, Artesunate, ascorbic acid,
asparaginase, atazanavir, atenolol, atropine, azathioprine, Azithromycin,

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148 Pharmacy PHARMACEUTICAL JURISPRUDENCE
ESSENTIAL MEDICINES LIST
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barium sulfate, BCG vaccine, beclometasone, benzathine benzylpenicillin, kanamycin, ketamine,
benznidazole, benzoic acid + salicylic acid, benzoyl peroxide, benzyl ben-
lamivudine (3TC) lamivudine + nevirapine stavudine lamivudine

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zoate, benzylpenicillin, betamethasone, biperiden, bleomycin, budesonide,
bupivacaine, nevirapine + zidovudine, lamivudine + zidovudine, levamisole, levodopa +
carbidopa, levonorgestrel. levonorgestrel-releasing implant, levothyroxine,
caffeine citrate, calamine lotion, calcium folinate, calcium gluconate,

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lidocaine, lidocaine + epinephrine (adrenaline), lithium carbonate, lopinavir
capreomycin, carbamazepine, carboplatin, cefalexin, cefazolin, cefixime, + ritonavir (LPV/). lorazepam, Lugol's solution,

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cefotaxime, ceftazidime, ceftriaxone, charcoal activated, chlorambucil, chlo-
ramphenicol, chlorhexidine, chlorine base compound, chloroquine, magnesium hydroxide, magnesium sulfate, mannitol, meastes vaccine,
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chloroxylenol, chlorphenamine, chlorpromazine, cholecalciferol, cholera vac mebendazole, medroxyprogesterone acetate, mefloquine, meglumine

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cine, ciclosporin, ciprofloxacin, clindamycin, clofazimine, clomifene, iotroxate, melarsoprol, meningococcal meningitis vaccine, mercaptopurine,
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clomipramine, clotrimazole, cloxacillin, coal tar, codeine, condoms, copper mesna, metformin, methadone, methotrexate, methyldopa, methylrosanilinium
chloride (gentian violet), methylthioninium chloride (methylene blue),
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containing device, cyclophosphamide, ycloserine, cytarabine,
metoclopramide, metronidazole, miconazole, mifepristone, misoprostol, mor-
dacarbazine, dactinomycin, dapsone, daunorubicin, deferoxamine, Dex phine, mumps vaccine,
amethasone, dextran 70, diaphragms, diazepam, didanosine (ddI),
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diethylcarbamazine, digoxin, diloxanide, dimercaprol, diphtheria antitoxin, naloxone, neomycin sulfate + bacitracin, neostigmine, nevirapine (NVP),
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diphtheria vaccine, dithranol, DL-methionine, dopamine, doxorubicin, doxy- niclosamide, nicotinamide, nicotine replacement therapy (NRT), nifedipine,
cycline, efavirenz (EFV or EFZ), efaviren + emtricitabine tenofovir, nifurtimox, nitrofurantoin, nitrous oxide, norethisterone, norethisterone
eflornithine, emtricitabine (FTC), emtricitabine + tenofovir, enalapril, ephe- enantate, nystatin,
drine, epinephrine (adrenaline), ergocalciferol, ergometrine, erythromycin, ofloxacin, omeprazole, ondansetron, oral rehydration salts, oseltamivir,
estradiol cypionate medroxyprogesterone cetate, ethambutol, ethambutol oxamniquine, oxygen, oxytocin,
+isoniazid, ethambutol + isoniazid + pyrazinamide + rifampicin, ethambu- P-aminosalicylic acid, pancreatic enzymes, paracetamol, paromomycin,
tol + isoniazid + rifampicin, penicilamine, pentamidine, permethrin, pertussis vaccine, Phenobarbital,
ethanol, ethinylestradiol, ethinylestradiol+ levonorgestrel, ethinylestradioi phenoxymethylpenicillin, phenytoin, phytomenadione, pilocarpine, pneumo-
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+norethisterone, ethionamide, ethosuximide, etoposide, coccal vaccine, podophyllum resin, poliomyelitis vaccine, polyvidone iodine,
factor IX complex (coagutation factors, II, VII, IX, X) concentrate, potassium chloride, potassium ferric hexacyano-ferrate(1I) -2H20, (Prussian
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factor VIII concentrate, ferrous salt, ferrous salt + folic acid, fluconazole, blue), potassium iodide, potassium permanganate, praziquantel prednisolone,
flucytosine, fludrocortisones, fluorescein, fluorouracil, fluoxetine, fluphena- primaquine, procaine benzylpenicillin, procarbazine, proguanil, promethaz-
ine, propranolol propylthiouracil, prostaglandin E, protamine sulfate, purified
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zine, folic acid, furosemide, :

protein derivative (PPD), pyrantel, pyrazinamide, pyridostigmine, pyridox-

gentamicin, glibenclamide, glucose, glucose with sodium chloride,
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îne, pyrimethamine,
glutaral, glyceryl trinitrate, griseofulvin,
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quinine,
haemophilus influenzae type b vaccine, haloperidol, halothane, heparin
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sodium hepatitis A vaccine, hepatitis B vaccine, human normal immu- rabies immunoglobulin, rabies vaccine, ranitidine, retinol ribavirin,
riboflavin, rifabutin, rifampicin, ritonavir, rotavirus vaccine, rubella vaccine,
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noglobulin, hydralazine, hydrochlorothiazide, hydrocortisone,

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hydroxocobalamin, hydroxycarbamide, salbutamol, salicylic acid, saquinavir (SQv), selenium sulfide, senna,
ibuprofen, ifosfamide, imipenem + cilastatin, indinavir (IDV), influenza silver sulfadiazine, simvastatin, sodium calcium edentate, sodium chloride,
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vaccine, insulin injection (soluble), intermediate-acting insulin, intraperito- sodium fluoride, sodium hydrogen carbonate, sodium lactate, sodium ni-
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neal dialysis solution (of appropriate composition), iodine, iohexol, trite, sodium nitroprusside, sodium stibogluconate or meglumine antimoniate,
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ipratropium bromide, isohiazid, isoniazid + Pyrazinamide + rifampicin, sodium thiosulfate, speginom:; cin, spironulactone, stavudine (d4T), strep-
isoniazid + rifampicin, isosorbide dinitrate, ivermectin, tokinase, streptomycin. Sulfadiazine, sulfadoxine + pyrimethamine,
sulfamethoxzole + trimethoprim, sulfasalazine, suramin sodium, surfactant,
Japanese encephalitis vaccine SUxamethonium,
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150

tamoxifen, tenofovir disoproxil fumarate, testosterone, tetanus vaccine,

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tetracaine, tetracycline, thiamine, thiopental, timolol, triclabendazole,
trimethoprim, tropicamide, tuberculin, REVISION QUESTIONS

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typhoid vaccine,
1.1 Define Jurisprudence. Trace out the history of drug legislation in

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urea,
vecuronium, verapamil, India.
valproic acid, vancomycin, varicella vaccine,
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vinblastine, vincristine, 1.2 Explain the objectives and scope of Pharmaceutical Legislation in

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India.
warfarin, water for injection,
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xylometazoline, 1.3 How did the concept of pharmacy evolve as an integral part of the
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Health Care System?
yellow fever vaccine,
1.4 Explain the role of pharmacist as member of Health Care Team.
zidovudine (ZDV or AZT), zinc sulfate
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1.5 Write notes on:
(a)DrugsEnquiry Committee
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(b) Bhore Committee
)Pharmacy Bill
2.1 Explain the scope and purpose of Code of Ethics.
2.2 Describe the Code of Ethics of a pharmacist (any two):
(a) in relation to his job
(b) in handling of prescriptions
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C)in relation to his trade
() in relation to medical profession
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(e) in relation to his profession
2.3 State the Pharmacists' Oath'. How can a pharmacist fulfill it?
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3.1 What are the aims and objects of the Pharmacy Act? Explain briefly
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the main features of the Act to achieve these objects.
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3.2 Define the terms 'Central council, 'Central register, 'Registered phar-
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macist, and 'State Council.
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3.3 Describe the constitution and functions of Pharmacy Council of India.

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3.4 Compare the constitution and functions of State Pharmaoy Councils
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and Joint State Pharmacy Councils.

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name from
3.5 Describe the grounds and procedure for removal of
Register of Pharmacists. Can such names be restored?
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3.6 (a) What procedure is followed by PCI for granting approval to the
pharmacy courses and institutions?
(6) How and when can such approval be withdrawn?

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152 PHARMACEUTICAL JURISPRUDENCE REVTSION QUESTIONS
153

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3.7 Write notes on: 4.6 Discuss the provisions of Schedule in detail.
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(a) Central Register or

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(b) Education Regulation, Define 'Pharmacy' and give its require ments of premises, furniture etc.
()Practical Training 4.7 (a) How many types of licences can be issued for the sale of drugs?

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3.8 State with reasons whether the following statements are right or (b) Describe the general procedure for obtaining a sale licence
wrong. Correct the wrong statements and rewrite them: stating the conditions to be satisfied.

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) A pharmacist registered in Maharashtra can practice pharmacy in 4.8 What are the qualifications for appointment as Drugs Inspector?
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any state in India. Explain their powers and procedures.

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()Education Regulations are prepared and imposed by State Phar 4.9 Compare the conditions precedent and subseque to the following
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macy Councils. sale licences:

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(i) Any person above 18 years of age and working in a medical store ( Drugs other those included in Schedule X
can get himself registered in the subsequent register of pharma-
(i) Drugs included in Schedule X
cists.
() Drugs other than those included in Schedule C, C1 andx
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(iv) If the name of registered pharmacist in a State is removed, he
(iv) Drugs specified in Schedule C and C1 excluding those specified in
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can get himself registered in the subsequent register of pharma-
Schedule X
Cists.
() A nominated or electd member of Central or State Pharmacy 4.10 Give minimum labeling requirements for allopathic drugs and specific
Council holds office for a period of 5 years. requirements for Schedule X drugs.
(vi) PCI Inspectors can inspect any drug store. 4.11 Write note on:
(vi) A Registered Pharmacist is the only person who can dispense () Sale of homoeopathic medicines
drugs on the prescription of a RMP. (i) Sale of drugs through motor vehicles
(i) Drugs which are prohibited to be sold
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3.9 Who could be registered in (a) first register, (6) subsequent register,
and () after formation of State Phamacy Councils? (iv) Wholesale of drugs
()Retail sale of drugs
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3.10 Describe the penalties for (a) falsely claiming to be registered
pharmacist, (b) dispensing by unregistered persons, and (c) failing to (vi) Patent and proprietary medicine
surrender certificate of registration; under the Pharmacy Act. 4.12 Give a brief account of the following:
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() Labeling of patent and proprietary medicines
4.1 Differentiate the terms "drug", "adulterated drugs", "misbranded
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drugs" and "spurious drugs".
() Retail sale of Schedule X drugs
,
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() Storage of Schedule H drugs

4.2 Differentiate the terms "cosmetics", "adulterated cosmetics", "spur-
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ous cosmetics" and "misbranded cosmetics". 4.13- Write general abeling requirements for the following classes of drugs:
) Schedule C and Ci drugs
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4.3 (a) To whom 'restricted licences' can be issued?

(i) Schedule X drugs
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(6) What are the conditions of such licences?
(ii) Schedule H andL drugs
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4.4 Name the drugs which should not be sold by retail except on the (iv) Ayurvedic and Unani drugs
prescription of a qualified physician.
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(v) Homeopathic medicine
4.5 (o) Discuss the provisions of the Act applicable to the sale of
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(vi) Schedule H1 drugs

homeopathic medicines.
4.14 (a) How should stock of drugs be disposed when sale licence is
(6) How are such drugs required to be labeled?
cancelled?
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Insta - Study_Pharmacy_29
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154
5.7 State whether following statements are right or wrong. Correct the
(b) How should date expired drugs be disposed?

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wrong statements and rewrite them:
wrong. Correct the
4.15 State whether following statements are right or (a) Central Government can permit advertisement of any drug other
wrong statements and rewrite them: wise prohibited, by notification in the Official Gazette.

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a RMP.
() All injections are to be supplied on the prescription of (6) A R.M.P. can advertise a magic remedy for treating headache.
meet I.P. specifications is called a
(i) Any drug which does not

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(c) Advertisements relating to "obesity and leucoderma" are not
misbranded drug. prohibited as they are not covered under the Act and Rules.
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person.
i) Ephedrine sulphate can be sold in absence of a qualified (d) An advertisement undertaking cure of baldness by hair transplan

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iv) A drug is an essential coinmodity. tation is objectionable.
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(V)A drug purchased by a retailer from an unlicensed dealer

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(e) A Drugs Inspector can seize the stock of magic remedies.
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deemed to be a misbranded drug.
Schedule X 5.8 (a) How can advertisements be sent confidentially.
(vi) The caution 'Poison' is necessary on the label of
(b) Discuss the advertisements whose import and export is prohib-
drugs.
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as ited.
(vii)No licence is necessary to stock or distribute drugs labelled
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Physicians sample - Not for sale'.
6.1 Define the terms "Narcotic drug", "Psychotropic substances", "Opium"
(viii) No drug can claim to cure menstrual disorders. and "Opium derivatives".
labelled as I.P.
(ix) Drugs labelled as BP or USP are superior to those 6.2 Discuss the operations which are totally prohibited and those which
(x) All injections should be stored in refrigerator.
are permitted by the Central and State Governments.
(xi) A Drugs Inspector is under the control of
Superintendent of
6.3 Compare the powers of State ana Central Governments to permit,
Police. control and regulate the Narcotic Drugs and Psychotropic Substances.
of drugs.
4.16 State the offences and penalties relating to 'sale 6.4 State the offences and penalties relating to () external dealings in
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Schedule G, H, and X.
4.17 (a) Name three drugs each from Narcotic Drugs and Psychotropic Substances, (in) Psychotropic Sub-
(b) Name the drugs which are to be sold only under generic names. stances, (i) Import, Export, Transhipment of Narcotic Drugs and
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Name five drugs which should be stored "In a well-closed Psychotropic Substances.
()
container, protected from light, in a cool place". 6.5 How do the following differ:
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drugs?
4.18 (a) What warning is essential for Schedule Hi (a) small quantity & commercial quantity.
names of drugs which should be marketed under generic (6) narcotic drug & psychotropic substance.
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(6) Give
names only. (c) controlled substance & psychotropic substance.
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Magic Remedies Act?

(d) Opium & Opium derivative.
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5.1 What are the objects of Drugs and
remedies.
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5.2 Define the terms 'advertisement' and 'magic 7.1 Define the terms: ceiling price, maximum retail price (MRP).
dealer, distributor, formulation, generic version of a medicine,
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advertisements are prohibited?
5.3 What classes of margin to retailer, National List of Essential Medicines.
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5.4 What advertisements are exempted? 7.2 How are price of formulations listed in the NLEM fixed?
are (a) prohibited, and (6) ex-
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5.5 Compare the advertisements which 7.3 How are prices of Scheduled and non-Scheduled formulations moni-
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empted?
ditic,ialy? Men- tored?
5.6 (a) What classes of advertisements are exempted ica, 7.4 Discuss the provisions relating to price list and display of prices of
tion their conditions.
be claimed to non-Scheduled formulations.
(6) Mention the names of ten diseases which can not
be cured.
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156 PHARMACEUTICAL JURISPRUDENCE REVISION QUESTIONS
157

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7.5 (o) Discuss the provisions of the Order relating to the issue of price 10.6 Discuss whether the termination of pregnancies under the following
lists. circumstances will be deemed to be legal or not

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(b) How are the prices of formulations to the wholesalers and () Termination of the pregnancy of a woman of 18 years of age
retailers calculated? without the consent of her guardian?
(i) Termination of pregnancy of a woman of 35 years who is

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7.6 Define the terms: (a) new drug, (6) non-scheduled formulation,
(c) Pharmacoeconomics, mentally unbatanced?
(d) price list, (e) price to retailer,.

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(i) Termination of pregnancy at the residence of a RMP?
retail price, 9 retailer, (h) scheduled formulation,
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(i) wholesaler, and ) brand.

11.1 What are the objects of Consumer Protection Act? Define "consumer"

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7.7 Write notes on: under the Act.
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(o) Fixation of retail price of a new drug for existing manufacturers 11.2 Define the terms: 'complaint', 'defect, 'deficiency, 'restrictive trade
of scheduled formulations.
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practice, 'service', 'spurious goods and senrvices, and 'trader.
(6) Revision of ceiting pice of scheduled formulations.
() Power of entry, search and seizure. 12.1 How is Right To Information Act related to pharmacist? What are the
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objects of the Act?
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8.1 () What is the object of Poisons Act?
12.2 Define the terms "appropriate Government", "Central Information
(6) Mention the provisions for possession and sale of poisons under
Commission", "Central Public Information Officer". "Chief Information
the Act. Commissioner and Information Commissioner", "competent authority",
8.2 What are the penalties under the Poisons Act? Who can make rules "information", "record", "right to information", and "third party".
under Poisons Act? 12.3 (a) How does "information" differ from "right to infomation" under
9.1 Define the terms "dutiable goods', "denatured alcohol", "absolute
the Act?
alcohol", and "rectified spirit". (6) What Information may be refused under the Act?
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9.2 Define and compare (e) medicinal preparation, (b) toilet preparation,
and (c) "restricted preparation".
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9.3 Compare the manufacture, of alcohotic preparations () in bond, and
(i) outside bond.
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9.4 Describe the construction of a bonded laboratory.
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10.1 Define "minor", "guardian", and "lunatic" under the Medical Termina-
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tion of Pregnancy Act. What are the objects of this Act?

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10.2 Under what conditions can a pregnancy be terminated under the Act?
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10.3 Who can terminate a pregnancy? What experience/training should

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such person possess?
10.4 What do you mean by "approved place"? Discuss the provisions of
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the Medical Termination of Pregnancy Act.relating to the approval of

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a place for the termination of pregnancy.
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10.5 How should the record of medical termination of pregnancies be

maintained?
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Insta - Study_Pharmacy_29
Telegram - Study Pharmacy INDEX 159

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Ethics, 8 Medicinal and Toilet Preparations Act,
Education regulations, 18 125

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Index Essential medicines, 147 offences and penalties, 129
list of, 109, 147 revision questions, 156
Adulterated drugs, 29 Cosmetics, 29 WHO model list, 147 Medicinal preparations, 125
adulterated 31

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Advertisements, 88 Excise Duties Act, 125 Misbranded drugs, 29
exempted, 89 labeling, 63 MRP, 1088

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prohibited, 88 misbranded, 31 Fair trade practices, 12
sale, 49 First register, 22 Narcotic, 125
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Agreement, 16
Alcohol, 125 spurious, 32 Formulation, 108 Narcotic drug, 94, 125

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absolute, 126 standard 65 non-scheduled, 108, 114 Narcotic Drugs and Psychotropic Sub-
scheduled, 109 stances Act, 92
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denatured, 126
Approval 16 Dealer, 107 sale price, 109 offences and penalties, 98
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Defect, 138 revision questions, 155
Bhore Committee, 5 Deficiency, 138 Generic version of a medicine 108 Non-bonded manufactory, 126
Bonded manufactory, 126,127 Dispensing and compounding of drug95, Guardian, 132
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Brand107 41 Opium, 94
Dispensing by unregistered persons, Handling of prescriptions, 10 derivatives, 94
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Cannabis, 93 Health Sunvey and Development Com-
27 or proprietary medicine, 29,
Ceiling price, 107 mittee, 5 Patent
Displaced person, 25
Central council, 16 Homeopathic medicines, 31 32
Distributor, 107
Central Information Commission, 140, Pharmacist in relation to his job, 10
District Forum, 139 Ilicit traffic, 95
144 Drugs, 28, 88, 103
medical profession, 14
Information, 141 profession. 14
Central license approving authority, adulterated, 30 Information that may be refused, 143 trade, 12
29 ayurvedic siddha or unani, 29, 31
Central Public Information Officer, 140
Inter-State agreement, 20 profession, 10
new 109
Pharmacists' Oath, 14
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Chemists and druggists, 41 date expired, 50 Joint state pharmacy councils, 21
Chief Information Commissioner and Pharmacoeconomics, 109
manufactured, 94 Jurisprudence, 1
Information Commissioner, 1444 Pharmacovigilence, 109
misbranded, 29, 30
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Chopra Committee, 6 Labeling of ayurvedic and unani drugs, Pharmacy (Schedule N), 41
sale, 35
Central register, 16, 19, 20 63 Pharmacy Act 16
retail, 39
Coca derivative, 93 cosmetics, 64 revision questions, 151
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wholesale, 37
Coca leaf, 93 homeopathic medicines, 63 Pharmacy and health care, 1
spurious, 30 Pharmacy Bill, 5
Labeling requirements, general, 50
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Code of Pharmaceutical Ethics, 8 Drugs and Cosmetics Act, 28
revision questions, 151 special, 58 Pharmacy Enquiry Committee, 6
offences and penalties, 47
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Commercial quantity, 94 Life periods of drugs, 78 Pharmacy Council of India, 17

revision questions, 152 Local taxes 108
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Community pharmacist, 4 Drugs and Magic Remedies Act, 87 Poisons Act, 123
Competent authority, 141 Lunatic, 132 penalties, 124
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offences and penalties, 91 revision questions, 156

Complaint, 137 revision questions, 154
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Magic remedy, 88 Poisons, import of, 123
Consumer, 138 Drugs inspectors, 71 Manufacture in bond, 127 possession and sale, 123
Consumer Dispute Redressal Agencies,
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powers, 772 outside bond, 128

139 Practical training, 18
procedure, 73
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Maximum retail price, 108 Price to retailer, 109
Consumer Protection Act, 137 qualifications, 72 Medical Termination of Pregnancy Act, Psychotropic substances, 95
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revision question, 1557 Drug legislation in India, 4 132

Controlled substances, 94 revision questions, 151 Qualified person, 25, 36
admission register, 136
Controlling authorities, 71 Drugs (Prices Control) Order, 107 approval of. place, 135
qualifications, 71 revision questions, 155 revision qdestions, 156
Dutiable goods, 125
158
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160

Record, 141

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3, 77, 91
Registered Medical Practitioner (RMP), P, 78
133 P1, 85

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Registered pharmacist, 16, 37 W, 85
Registration of pharmacists, 22 86
Registration tribunal, 22 Service, 138

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Removal of names from register, 26 Smal quantity, 94
Restricted licenses, 36, 40 Spirit, denatured, 126

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preparation, 126 rectified, 126
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Restrictive trade practice, 138 Spurious goods and services, 139

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Retail price, 109 State Chief Information Commissioner
Retailer, 109 141
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Revision Questions, 151 State Information Commission 141

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Right to information, 141 State Information Commissioner, 142
Right To Information Act, 140 State pharmacy councils, 20
revision question, 157 Joint, 21
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Right to information and obligations State Public Information Officer, 142
of public authorities, 142
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Subsequent register, 23
Sub-standard preparations, 126
Sale of ayurvedic drugs, 46
cosmetics, 49 Termination of pregnancy, 133
drugs, 36 Third party, 142
homeopathic medicines, 49 Toilet preparations, 126
Schedule G, 74
75 Warehouse, 127
H1, 77 Wholesaler, 109
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