DRUGS AND COSMETICS ACT, 1940 AND ITS RULES 1945

 DRUGS AND COSMETICS ACT, 1940

AND ITS RULES 1945

The Central Legislative Assembly passed the Drugs and Cosmetics Act 1940 and rules

1945 with an objective to regulate the import, manufacture and distribution and sale of

drugs and cosmetics. It is applicable on Allopathic, Homeopathic, Unani and Siddha drugs as

well on contraceptives, mosquitoe repellents, creams, lotions, cosmetics and devices used for

internal and external use for diagnosis. Under this Act, the regulation of manufacture, sale

and distribution of Drugs is primarily the concern of the State authorities while the Central

authorities are responsible for approval of New Drugs, Clinical trials in the country, laying

down standards for Drugs, control over the quality of imported drugs, co-ordination of the

activities of Drug Control Organization and providing expert advice with a view of bringing

about uniformity in the enforcement of Drug and Cosmetic Act.

DEFINITIONS

Drug:

 (i) All medicines for internal or external use of human beings or animals and all

substances intended to be used for or in the diagnosis, treatment, mitigation or prevention

of any disease or disorder in human beings or animals, including preparations applied on

human body for the purpose of repelling insects like mosquitoes.

 (ii) Such substances (other than food) intend to affect the structure or any function of the

human body or intended to be used for the destruction of vermin or insects which cause

disease in human beings or animals.

 (iii) All substances intended for use as components of a drug including empty gelatin

capsules; and

 (iv) Such devices intended for internal or external use in the diagnosis, treatment,

mitigation or prevention of disease or disorder in human beings or animals.

Ayurvedic, Siddha or Unani Drug:

 It includes all medicines intended for internal or external use of human beings or animals

for diagnosis, treatment, mitigation or prevention of disease or disorder in accordance with

the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb

system of medicine, specified in first schedule.

Misbranded Drugs:

A drug shall be deemed to be misbranded:

 (i) If it is so colored, coated, powdered or polished that damage is concealed or if it is

made to appear of better or greater therapeutic value than it really is; or

 (ii) If it is not labelled in the prescribed manner; or

 (iii) If its label or container or anything accompanying the drug bears any statement,

design or device which makes any false claim for the drug or which is false or

misleading in any particular.

Adulterated Drugs:

A drug shall be deemed to be adulterated:

 (i) If it consists, in whole or in part, of any filthy, putrid or decomposed substance; or

 (ii) If it has been prepared, packed or stored under insanitary conditions whereby it may

have been contaminated with filthy or whereby it may have been rendered injurious

to health; or

 (iii) If its container is composed in whole or in part, of any poisonous or deleterious

substance which may render the contents injurious to health; or

 (iv) If it bears or contains, for purposes of coloring only, a colour other than one which is

prescribed; or

 (v) If it contains any harmful or toxic substance which may render it injurious to health;

or

 (vi) If any substance has been mixed therewith so as to reduce its quality or strength.

Spurious Drugs:

A drug shall be deemed to be spurious:

 (i) If it is manufactured under a name which belongs to another drug; or

 (ii) If it is an imitation of, or is a substitute for, another drug or resembles another drug

in a manner likely to deceive or bears upon it or upon its label or container the name

of another drug unless it is plainly or conspicuously marked so as to reveal its true

character and its lack of identity with such other drug; or

 (iii) If the label or container bears the name of an individual or company purporting to be

the manufacturer of the drug, which individual or company is fictitious or does not

exist; or

 (iv) If it has been substituted wholly or in part by another drug or substance., or

 (v) If it purports to be the product of a manufacturer of whom it is not truly a product.

Drug Inspector:

 A Drug Inspector appointed by the Central Government or a State Government who is

an expert and qualified to monitor the safety, utility, efficacy and quality of a drug from its

manufacturing till its sale at the retail shop.

Cosmetic:

 Any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or

otherwise applied to, the human body or any part thereof for cleansing, beautifying,

promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic

Drug Store:

 Licensed premises for the sale of drugs, a retail store which do not require the services of

a qualified person and sells both prescription and non-prescription drugs.

Pharmacy:

Licensed premises for the sale of drugs, which require the services of a qualified person

but where the drugs are not compounded against prescriptions.

Qualified Person:

(i) He is a person holding diploma or degree in Pharmacy or Pharmaceutical Chemistry;

or

(ii) Is a registered pharmacist, (under Pharmacy Act, 1948); or

(iii) Has minimum 4 years experience of dispensing and has been approved by licensing

authority as a ‘Qualified Person’ on or before 31st Dec 1969.

Government Analyst:

 A Government Analyst appointed by the Central Government or a State Government who

shall analyse or test or cause to be analysed or tested such samples of drugs as may be sent

to him by Inspectors or any other persons or authority authorised by the Central Government

or a State Government and shall furnish reports of the results of test or analysis in

accordance with these rules.

 Further, shall from time to time forward to the Government reports giving the results of

analytical work and research with a view to their publication at the discretion of the Government