Control Of Spurious Drugs Notes for Reference Purpose only

1. DRUGS AND COSMETICS ACTS, 1940
(CONTROL OF SPURIOUS DRUGS)
Introduction:
 Generally, a drug shall be deemed to be Spurious if it is
manufactured under a name which belongs to another drug, if it is
an imitation of another drug or if it has been substituted wholly or
partly by another drug or if it wrongly claims to be the product of
another manufacturer.
 The term “Spurious Drug‟ has been defined under Section-9B and
Section-17B of the Drugs and Cosmetics Act, 1940.
 Counterfeiting of commercial products, including medicines, is a
global issue and is reported in many countries. Circulation of
spurious drug can lead to negative consequences on both
consumers and manufacturers.
Section-9B: Spurious Drugs
As per the Act, a drug shall be deemed to be spurious drug if –
a. it is imported under a name which belongs to another drug;
b. 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
c. 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
d. it has been substituted wholly or in part by another drug or
substance; or
e. it purports to be the product of a manufacturer of whom it is not
truly a product.
Imported Drugs and cosmetics:
Section 10: The Central Government has power to prohibit import of
drugs or cosmetics of non- standard quality, or misbranded,

2. adulterated or spurious drugs or importing without licence, importing
a drug whose import itself if prohibited, importing unsafe cosmetics
etc.
Section 10A: if the Central Government is satisfied that the, use of any
drug or cosmetic may involve any risk to human beings or animals or
that any drug does not have the therapeutic value claimed then the
Government may, by notification in the Official Gazette, prohibit the
import of such drug or cosmetic in the public interest.
Section 13- Any person who imports any drug or cosmetic which is
prohibited shall be punishable with imprisonment upto 3 years and
with a fine of Rs 5000 or both. The consignments of drugs and
cosmetics in such cases will be liable to confiscation.
Manufacture, Sale and Distribution of Drugs and Cosmetics
1. No person shall himself or through his agent manufacture for sale,
distribute, sell or stock or exhibit or offer for sale drugs and
cosmetics which are not of standard quality, or misbranded,
adulterated or spurious or in contravention of the provisions of the
Act.
2. Both the Central Government and the State Governments can
appoint inspectors under the Act.
3. The Penalty for manufacture, sale, etc. of drugs and cosmetics
entails periods of imprisonment from three years to life and fine
upto Rs.10,000/-. It shall be no defence for the accused to say that
he was ignorant about the nature, substance or quality of the drug
or cosmetic or that the purchaser or user was not prejudiced by the
sale.
Ayurvedic, Siddha and Unani Drugs
1. There is a separate Technical Advisory Board, Consultative
Committee.
2. It is prohibited to manufacture and sale of Ayurvedic, Sidha and
Unani drugs which may not be of the requisite standards, quality,
or which may be adulterated, misbranded or spurious has been
provided for with corresponding penalties for their breach.

3. Regulating agencies:
Section-5 Drugs Technical Advisory Board (DTAB)
a. It is constituted to advise the Central Government and the State
Governments on technical matters arising out of the
administration of the Drugs and Cosmetics Act and to carry out
the other functions assigned to it by the Act.
b. It consists of Director-General of Health Services as Chairman,
the Drugs Controller, Directors of Central Drugs Laboratory,
Central Research Institute, NRI, Medical Council of India,
Pharmacy Council of India, Nominees of the Central Government,
Pharmacy teachers, representatives of pharmaceutical industry,
etc.
c. The Board may make Bye-laws for its own regulation and function
through Sub-committee.
Section-6 Central Drugs Laboratory
a. This is established by the Central Government under the Control
of a Director to carry out functions laid down under the Act.
b. Rules provide for the procedure for admission of samples of drugs
or cosmetics for analysis or test, forms of reports, fees to be paid,
etc.
Section-7 Drugs Consultative Committee (DCC)
a. The Drugs Consultative Committee (DCC) is constituted by the
Central Government.
b. It is an advisory committee and has the responsibility to advise
the Central Government, the State Governments and the Drugs
Technical Advisory Board on matters related to uniform
administration of the Drugs and Cosmetics Act throughout India.
c. It shall consist of two representatives of the Central Government
to be nominated by that Government and one representative of
each State Government to be nominated by the State Government
concerned.

4. Enforcement agencies: Section-21: Inspectors
a. The inspectors under the Drugs and Cosmetics Act are known as
Drug Inspectors.
b. The drug inspector is a public servant within the meaning of the
Indian Penal Code.
c. A drug inspection can inspect, search, verify or examine any:
1. premises wherein a drug or cosmetic is being manufactured or
tested for quality and can take samples for further tests or
actions.
2. premises where a drug or cosmetic is sold, stocked, exhibited,
offered for sale or distribution.
3. person or vehicle who is reasonably believed to have committed
an offence under the Drugs and Cosmetics Act.
4. record, register, document or any other material object found
with any person, or in place, vehicle, vessel related to the
manufacture sale or dealing of drugs and cosmetics.
The inspection or search has to be done only at reasonable times, with
such assistance, if any, required. The inspector has to comply with the
procedure for taking sample as prescribed in the Act.