Subject Name: Socio economic offences

Department of: Law

Created By: Prashant Pandey

JIMS Engineering Management Technical

Campus
48/4, Knowledge Park-III,Greater Noida - 201308
(Affiliated to Guru Gobind Singh Indraprastha University, New Delhi)
Subject: Drugs and Cosmetics Act 1940
List of Topics to be covered(Optional)

▰ Introduction
▰ Objectives
▰ Definitions
Introduction

▰ The Drugs and Cosmetics Act was passed based on the

recommendations of the Chopra Committee Report

▰ The Act was originally Drugs Act 1940 and it was later
renamed as Drugs and Cosmetics Act 1940 when cosmetics
were also brought under its purview in the year 1962. It was so
made with the objective of regulating the manufacture of
cosmetics.
Content Slide

▰ The application of various organic synthetic materials in the

cosmetic formulation made it necessary to ensure that nothing is
used in cosmetics which are deleterious to the health of people.

▰ The Rules under the Drugs and Cosmetics Act were first made in
1945 and was later amended / modified number of times to
incorporate newer provisions and regulations.
▰ The Drug and Cosmetics Act, 1940 was enacted by the
Department of Health under the Ministry of Health and
Family Welfare after receiving the assent of the Governor
General on April 10, 1940 and came into force on April 1,
1947.
Objectives

▰ To regulate the import, manufacture, distribution and sale of

drugs & cosmetics through licensing.

▰ Manufacture, distribution and sale of drugs and cosmetics

by qualified persons only.

▰ To prevent substandard in drugs, presumably for

maintaining high standards of medical treatment.
▰ To regulate the manufacture and sale of Ayurvedic, Siddha
and Unani drugs.

▰ To establish Drugs Technical Advisory Board (DTAB) and

Drugs Consultative Committees (DCC) for Allopathic and
allied drugs and cosmetics.
Salient features

▰ Maximum penalty life imprisonment and fine of Rs. 10

lakhs or 3 times the value of the confiscated goods,
whichever is more.

▰ Besides officers from the Drug Controller’s Office, other

gazette officers also authorized to launch prosecution under
the Act;
▰ Some of the offences cognizable and non-bailable;

▰ Specially designated courts for trial of offences covered

under the Act;

▰ Provision for compounding of minor offences.

Cosmetic: Section 3 (aaa)

▰ Cosmetic means any article intended to be rubbed, poured,

sprinkled or sprayed on, or introduced into, or otherwise
applied to, the human body or any part thereof for
cleansing, beautifying, promoting attractiveness, or altering
the appearance, and includes any article intended for use as
a component of cosmetic.
▰ Talcum powder, nail polish, perfumes, lip-stick etc are
examples of cosmetics.
Drugs: Section 3(b)

The Act says that “drug” includes—

▰ i) all medicines for internal or external use of human
beings or animals and all substances intended to be used
for or in the diagnosis, treatment, mitigation or prevention
of any disease or disorder in human beings or animals,
including preparations applied on human body for the
purpose of repelling insects like mosquitoes;
▰ ii) such substances (other than food) intended to affect the
structure or any function of human body or intended to be
used for the destruction of (vermin) or insects which cause
disease in human beings or animals, as may be specified
from time to time by the Central Government.
▰ iii) all substances intended for use as components of a
drug including empty gelatin capsules; and

▰ iv) such devices intended for internal or external use in

the diagnosis, treatment, mitigation or prevention of
disease or disorder in human beings or animals, as may
be specified from time to time by the Central
Government by notification in the Official Gazette.
Chimanlal Jagjzvandas v. State of Maharastra, 1963 AIR
665
▰ The definition does not introduce a distinction between
medicines and substances which are not medicines strictly
so called. It cannot be disputed that absorbent cotton
wool, roller bandages and gauze are substances within the
meaning of the said expression.
▰ Court said, they are essential materials for treatment in
surgical cases. Beside being aseptic, these articles have to
possess those qualities which are utilized in the treatment
of disease.
▰ Similarly a substance which effect structure or function
of a body for example, weight reduction preparation,
harmone steroids cream, vitamin when administered as
drug or products which claim to cure baldness, etc. will
be considered as drug.
▰ Subodh S. Shah and Ors. V. Director, Foods and Drugs
Human blood was held to be drug since it is used in treatment
and diagnosis. For example, it is used in blood transfusion.

▰ Southern Gas Ltd. V. State of Kerala, 2005 (3) KLT 78

Similarly medical oxygen used in hospitals etc. is a drug so
far it is used as a therapeutic agent.
▰ The Drugs and Cosmetics Act (including the Rules) does not
define or distinguish the terms ‘drug’ and ‘medicine’.

▰ Drug is the crude or pure substance as such. It is often called

the active ingredient or principle. When the drug is
converted into a dosage form like tablet or liquid preparation
it becomes a medicine.
▰ Paracetamol is a drug and if it is made in the form of a
tablet or syrup that becomes a medicine.

▰ Though the term drugs and medicines are often used as

synonyms it is always better to use medicines to indicate
the various commonly used drug forms.
Misbranded drugs: Section 9

As per the Act, a drug shall be deemed to be misbranded if −

▰ i) it is so coloured, coated, powdered or polished that
damage is concealed or if it is made to appear of better or
greater therapeutic value than it really is; or
▰ ii) it is not labelled in the prescribed manner; or
▰ iii) its label or container or anything accompanying the
drug bears any statement, design or device which makes
any false claim for the drug or which is false or
misleading.
Adulterated Drug: Section 9-A

A drug will become adulterated drug if −

▰ i) it consists, in whole or in part, of any filthy, putrid or
decomposed substance; or
▰ ii) it has been prepared, packed or stored under insanitary
conditions whereby it may have been contaminated with filth
or whereby it may have been rendered injurious to health; or
▰ iii) its container is composed in whole or in part, of any
poisonous or deleterious substance which may render the
contents injurious to health; or
▰ iv) it bears or contains, for purposes of colouring only, a
colour other than one which is prescribed; or

▰ v) it contains any harmful or toxic substance which may

render it injurious to health; or

▰ vi) any substance has been mixed therewith so as to

reduce its quality or strength.
Spurious Drugs: Section 9-B

As per the Act, a drug shall be deemed to be spurious drug if –

▰ i) it is imported under a name which belongs to another
drug; or
▰ ii) it is an imitation of, or a substitute for, another drug or
resembles another drug in a manner likely to deceive or
bears upon it or upon its label or container the name of
another drug unless it is plainly and conspicuously marked
so as to reveal its true character and its lack of identity with
such other drug; or
▰ iii) the label or the container bears the name of an
individual or company purporting to be the manufacturer
of the drug, which individual or company is fictitious or
does not exist; or

▰ iv) it has been substituted wholly or in part by another

drug or substance; or

▰ v) it purports to be the product of a manufacturer of

whom it is not truly a product.
Misbranded cosmetics: Section 9-C

For the purposes of this Chapter, a cosmetic shall be deemed to

be misbranded
▰ (a) if it contains a colour which is not prescribed; or
▰ (b) if it is not labelled in the prescribed manner; or
▰ (c) if the label or container or anything accompanying the
cosmetic bears any statement which is false or misleading
in any particular.
Spurious cosmetics : Section 9-D

For the purposes of this Chapter, a cosmetic shall be deemed

to be spurious,
▰ (a) if it is imported under a name which belongs to another
cosmetic; or
▰ (b) if it is an imitation of, or is a substitute for, another
cosmetic or resembles another cosmetic in a manner likely
to deceive or bears upon it or upon its label or container
the name of another cosmetic, unless it is plainly and
conspicuously marked so as to reveal its true character and
its lack of identity with such other cosmetic; or
▰ (c) if the label or container bears the name of an individual
or a company purporting to be the manufacturer of the
cosmetic which individual or company is fictitious or does
not exist; or

▰ (d) if it purports to be the product of a manufacturer of

whom it is not truly a product.
Administration of the Acts and Rules

For efficient administration of the acts and rules, the following

agencies have been provided:
• Advisory
o Drugs Technical Advisory Board (DTAB)
o Drugs Consultative Committee
• Analytical
o Central Drugs Laboratory
o Drugs Control Laboratories in States
o Government Analysis
• Executive
o Licensing Authorities
o Controlling Authorities
o Drugs Inspectors
o Customs Collectors
Drugs Technical Advisory Board: Section 5

▰ Constituted by Central Government to advise the Central

and State Governments on technical matters arising out
of administrations of the Act

▰ It consists of 18 members of whom 8 are ex-officio, 5

nominated and 5 elected members.
Ex-officio members

▰ Director General of Health Sciences ( Chairman)

▰ Drugs Controller of India
▰ Director, Central Drugs Laboratory Calcutta
▰ Director Central Research Institute, Kasauli
▰ Director Indian Vetenary Research Institute, Izantnagar
▰ President, Pharmacy Council of India
▰ President, Medical Council of India
▰ Director, Central Drug Research Institute, Lucknow.
Nominated Members

▰ Two persons nominated by central Government from

amongst persons who are in charge of drugs control in
states.
▰ One person from Pharmaceutical Industry nominated by
the Central Government.
▰ Two Government Analysts, nominated by Central
Government.
Elected Members

▰ A teacher in pharmacy or pharmaceutical chemistry or

pharmacognosy on the staff of an Indian university or an
affiliated college, elected by the Executive Committee of
Pharmacy Council of India.
▰ A teacher in medicine or therapeutics on the staff of an
Indian University or an affiliated College, elected by the
Executive Committee of PCI
▰ One Pharmacologist elected by the Governing body of
ICMR
▰ One person elected by council of Central Medical
Education
▰ One person elected by Council of IPA.
▰ The nominated and elected members hold the office for
three years but are eligible for re-nomination and re-
election.

▰ The Central Government appoints a Secretary and provides

the clerical and other staff to the board.

▰ The board may appoint sub-committees and may appoint

persons who are not board members either temporarily or
for some period not exceeding 3 years.
The Drugs Consultative Committee (DCC):
Section 7

▰ DCC is constituted by the Central Government in order to

secure uniformity in the Act throughout India.
▰ It is an advisory committee for the central and State
Governments and the DTAB.
▰ It consisted of two representatives nominated by the Central
Government and one nominee of each of the state
Governments.
▰ The committee meet when required by the Central
Government & is empowered to regulate its own procedure.
The Central Drugs Laboratory: Section 6

▰ Provides for the establishment of a Central Drugs

Laboratory under the control of a director appointed by
Central Government, to carry out the functions entrusted to
it by this Act.

▰ There are seven National Laboratories in India engaged in

the research and analysis of Drug and Cosmetic as per the
Act of 1940.
Central Drug Testing Laboratory: CDTL

▰ Mumbai
▰ Chennai
▰ Kolkata
▰ Kasauli
▰ Hyderabad
▰ Chandigarh, and
▰ Guwahati
Functions of CDTL

▰ Analytical quality control of majority of the imported drug

available in Indian market.

▰ Analytical quality control of drug and cosmetics

manufactured within the country on behalf of the Central
and State Drug Controller Administration.

▰ Acting as an appellate authority in matters of dispute

relating to quality of drug.
▰ Workout analytical specifications for preparation of
monographs for the Indian Pharmacopoeia and the
Homeopathic Pharmacopoeia of India.

▰ To undertake analytical research on standardization and

methodology of drug and cosmetics.

▰ Analysis of cosmetics received as survey samples from

Central Drug Standard Control Organisation.
Government Analysts: Section 20

▰ State Government by notification in the Official Gazette,

appoint persons having sufficient qualifications to be
government Analysts for such areas in state & in respect of
such drugs and classes.
▰ Central Government may also similarly appoint Government
Analysts in respect of such drugs or classes of drugs or
cosmetics as specified.
▰ No person having any interest in the import, manufacture or
sale of drugs or cosmetics or is directly or indirectly engaged
in any trade or business connected with manufacture of drugs
can be appointed as Government analysts.
Qualifications

▰ A graduate in medicine/science/pharmacy/ pharmaceutical

chemistry of recognized University and have 5 yrs post
graduate experience in testing of drugs in a laboratory
under the control of 1) a Government Analyst or 2) head of
approved Institution or testing laboratory.
▰ A Post Graduate in medicine/science/pharmacy/
pharmaceutical chemistry of recognized University with at
least 3 years of experience in the testing of drugs in a
laboratory under the control of 1) a Government Analyst or
2) head of approved Institution or testing laboratory
Duties of Government Analyst

▰ Analyze or test samples of drugs/cosmetics sent to him by

inspectors or other persons under the act and to furnish
reports of the results of test or analysis.

▰ Forward to Government from time to time, reports giving

the results of analysis works and research with a view to
their publication at the discretion of Government.
Drugs Inspectors

▰ Appointed by Central and State Governments.

▰ He should be a person with out any financial interest in the
import, manufacture or sale of drugs or cosmetics.
▰ They are deemed as public servants and are officially
subordinate to the Controlling Authority.
Standards of quality: Section 8 and 16

The expression standard quality means:

▰ (a) in relation to a drug, that the drug complies with the
standard set out in the Second Schedule, and
▰ (b) in relation to a cosmetic, that the cosmetic complies
with such standard as may be prescribed.
▰ As per Section 16(2) the Central Government, after
consultation with the Board and after giving by
notification in the official gazette not less than three
months’ notice of its intention so to do, may by a like
notification add to or otherwise amend the Second
Schedule for the purposes of this chapter i.e. chapter IV
of the Act dealing with manufacture, sale and distribution
of drugs and cosmetics.
Prohibition of import of certain drugs or cosmetics:
Section 10

From such date as may be fixed by the Central Government by

notification in the Official Gazette in this behalf, no person
shall import
▰ (a) any drug [or cosmetic which is not of standard quality;

▰ (b) any misbranded drug or misbranded or spurious

cosmetic
▰ (bb) any adulterated or spurious drug;
▰ (c) any drug or cosmetic for the import of which a license
is prescribed, otherwise than under, and in accordance
with, such license;
▰ (d) any patent or proprietary medicine, unless there is
displayed in the prescribed manner on the label or
container thereof the true formula or list of active
ingredients contained in it together with the quantities
thereof
▰ (e) any drug which by means of any statement, design or
device accompanying it or by any other means, purports or
claims to cure or mitigate any such disease or ailment, or to
have any such other effect, as may be prescribed;
▰ (ee) any cosmetic containing any ingredient which may
render it unsafe or harmful for use under the directions
indicated or recommended;
▰ (f) any drug [or cosmetic the import of which is prohibited
by rule made under this Chapter:
▰ Nothing in this section shall apply to the import, subject
to prescribed conditions, of small quantities of any drug
for the purpose of examination, test or analysis or for
personal use
Prohibition of manufacture and sale of certain
drugs and cosmetics: Section 18

From such date as may be fixed by the State Government by

notification in the Official Gazette in this behalf, no person
shall himself or by any other person on his behalf
▰ (a) manufacture for sale or for distribution, or sell, or stock
or exhibit or offer for sale, or distribute
(i) any drug which is not of a standard quality, or is
misbranded, adulterated or spurious;
(ii) any cosmetic which is not of a standard quality, or
is misbranded, adulterated or spurious;
▰ (iii) any patent or proprietary medicine, unless there is
displayed in the prescribed manner on the label or
container thereof the true formula or list of active
ingredients contained in it together with the quantities,
thereof
▰ (iv) any drug which by means of any statement, design or
device accompanying it or by any other means, purports or
claims to prevent, cure or mitigate any such disease or
ailment, or to have any such other effect as may be
prescribed;
▰ (v) any cosmetic containing any ingredient which may
render it unsafe or harmful for use under the directions
indicated or recommended;

▰ (vi) any drug or cosmetic in contravention of any of the

provisions of this Chapter or any rule made thereunder;
▰ (b) sell, or stock or exhibit or offer for sale, or distribute any
drug [or cosmetic] which has been imported or
manufactured in contravention of any of the provisions of
this Act or any rule made thereunder;

▰ (c) manufacture for sale or for distribution, or sell, or stock

or exhibit or offer for sale, or distribute any drug or
cosmetic, except under, and in accordance with the
conditions of, a license issued for such purpose under this
Chapter
Thank You !!