Drugs and Cosmetics Act 1940

Presented By:
Anurag Mishra

Dr.

MBA (Health & Hospital)

History

British misrule-Providing poor healthcare system to Indian citizens

Observations made by-Drugs Enquiry Committee, Indian Medical

Association

Reports in- Indian Medical Gazette during 1920-30

1940 Drugs and Cosmetics Act

1945 Rules under the Act

Extended to whole of India

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.

The salient features of the Drugs & Cosmetics

Act, 1940 are as follows:

Maximum penalty life imprisonment and fine of Rs. 10 lakhs or 3 times

the value of the confiscated goods, whichever is more.

Some of the offences cognizable and non-bailable.

Besides officers from the Drug Controllers Office, other gazette officers
also authorized to launch prosecution under the Act;

Specially designated courts for trial of offences covered under the Act;

Provision for compounding of minor offences.

Definitions
Drugs :
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.

Cosmetic :
Any article intended to be rubbed, poured, sprinkled or sprayed on, 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.

Misbranded drugs :

if it is so coloured, coated, powdered or polished that damage is concealed

if it is not labelled in the prescribed manner; or

if its label or container or anything accompanying the drug bears any

statement, design or device which makes any false claim for the drug or
which is false or misleading in any particular.

Adulterated drug :
)

if it consists, in whole or in part, of any filthy, putrid or decomposed

substance; or

if 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

if its container is composed in whole or in part, of any poisonous or

deleterious substance which may render the contents injurious to health.

Spurious drugs :

if it is imported under a name which belongs to another drug; or

if 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.or

if it has been substituted wholly or in part by another drug or substance.

Administration of the act and rules

A) Advisory :
1)Drugs Technical Advisory Board-DTAB
2)Drugs Consultative Committee-D.C.C.
B) Analytical :
1)Central Drugs Laboratory - CDL
2)Drug Control Laboratory in states
3)Government Analysts
C) Executives :
1)Licensing authorities
2)Controlling authorities
3)Drug Inspectors

Drugs Technical Advisory Board(DTAB)

One person, to be elected by the Executive Committee of the

Pharmacy Council of India, from among teachers in pharmacy or
pharmaceutical chemistry on the staff of an Indian university or a
college affiliated.

One person, to be elected by the Executive Committee of the Medical

Council of India, from among teachers in medicine or therapeutics on
the staff of an Indian university or a college affiliated.

One pharmacologist to be elected by the Governing Body of the Indian

Council of Medical Research.

One person to be elected by the Central Council of the Indian Medical

Association.

One person to be elected by the Council of the Indian Pharmaceutical

Association.

Functions:
To advise the Central Government and the State Governments on
technical matters arising out of the administration of this Act.
To carry out the other functions assigned to it by this Act.
(The nominated and elected members of the Board shall hold office for
three years, but shall be eligible for re-nomination and re-election)

Drugs Consultative Committee(DCC)

It is also an advisory body constituted by central government.

Constitution:
Two representatives of the Central Government
One representative of each State Government

Functions:

To advise the Central Government, the State Governments and the

Drugs Technical Advisory Board on any other matter tending to secure
uniformity throughout India in the administration of this Act.

The Drugs Consultative Committee shall meet when required

Has power to regulate its own procedure.

Central Drug Laboratory(CDL)

Established in Calcutta, under the control of a director appointed by the Central

Government

Functions:

Analysis or test of samples of drugs/cosmetics sent by the custom collectors or

courts.

Analytical Q.C. of the imported samples.

Preparation of reference standards and their maintenance.

Maintenance of microbial cultures.

Any other duties entrusted by Central Government.

Acting as an appellate authority in matter of disputes.

Government analyst

These officers are appointed by the central or state government

and perform the duties.

Qualification of government analysis:

Having a degree in medicine, Ayurveda, siddha or unani system
and not less than three year post graduate experience in the
analysis of drugs in a laboratory under control of a government
analyst.
Duties:

The Government Analyst shall cause to be analyzed or tested such

samples or drugs and cosmetics as may be sent to him by
Inspectors.

A Government Analyst shall from time to time forward reports to

the Government giving the result of analytical work and research
with a view to their publication.

Licensing authority
Qualification:

Graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine with

specialization in clinical pharmacology or microbiology from a University
established in India by law; and

Experience in the manufacture or testing of drugs a minimum period of five

years, Provided that the requirements as to the academic qualification shall
not apply to those inspectors .

Duties:

To inspect all establishments licensed for the sale of drugs within the area
assigned to him;

To satisfy himself that the conditions of the licenses are being observed;

To procure and send for test or analysis, if necessary, imported packages.

To investigate any complaint.

To maintain a record of all inspections made and action taken by him in the
performance of his duties,

To make such enquiries and inspections as may be necessary to detect the

sale of drugs in contravention to the Act;

Controlling authority
Qualification:

Graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine

with specialization in clinical Pharmacology or microbiology from a
University established in India by law and

Experience in the manufacture or testing of drugs or enforcement of

the provisions of the Act for a minimum period of five years:

Drug Inspector
Qualification

A government analyst

A chemical examiner

Head of an institution.

Power:
a) Inspect, -

Any premises where in any drug or cosmetic is being manufactured.

Any premises where in any drug or cosmetic is being sold, or stocked

or exhibited or offered for sale, or distributed ;

(b) Take samples of any drug or cosmetic,-

Which is being manufactured or being sold or is stocked or exhibited

or offered for sale, or is being distributed;

From any person who is in the course of conveying, delivering or

preparing to deliver such drug or cosmetic to a purchaser or a
consignee.

Provision of Act
Import
Manufacturing
Sales

Import of Drugs
Classes of drugs prohibited to import:

Misbranded drugs

Drugs of substandard quality

Adulterated drugs

Spurious drugs

Drugs whose manufacture, sale/distribution are prohibited in

original country, except for the purpose of test, examination
and analysis.

Patent/Proprietary medicines whose true formula is not

disclosed.

Cosmetics prohibited to import

Misbranded cosmetics

Spurious cosmetics

Cosmetic containing harmful ingredients

Cosmetics not of standard quality

which contains more than-2 ppm Arsenic, 20 ppm lead, 100

ppm heavy metals

Manufacture
Prohibition of Manufacture

Drug not of standard quality or misbranded, adulterated or

spurious.

Patent or Proprietary medicine

Risky to human beings or animals

Drugs without therapeutic value

Preparation containing cyclamates

Manufacture of cosmetics
Prohibited for the following classes of drug:

Misbranded or spurious
substandard quality

cosmetics

Cosmetics containing hexachlorophene or mercury

compounds

Cosmetics containing color which contain more than- 2 ppm of arsenic

- 20 ppm of lead
- 100 ppm of heavy metals

Eye preparations containing coal-tar color

and

of

Sale
Class of drug prohibited to sale

Misbranded, spurious, adulterated and drugs not of standard

quality

Patent/Proprietary drugs with undisclosed formula

Expired drugs.

Drugs used for consumption by government schemes such as,

Armed force.

Physicians samples

Drugs and Cosmetics

(Amendment) Act, 2008
Salient features of the Act:

Substantial enhancement in punishment

Life imprisonment for offenders involved in

manufacture, sale and distribution of spurious and
adulterated drug likely to cause grievous hurt

Minimum punishment of seven years which may extend

to life imprisonment

Provision for compensation to affected person