Administration of Drugs and

Cosmetics Act 1940 and

Rules 1945

Drug Inspectors
 Administration of the Act and
Rules
 For efficient administration of the Act.
 Advisory: Drug Technical Advisory Board
Drugs Consultative committee
 Analytical: Central Drugs lab.
Drugs control lab. In states
Government analysts
 Executive: Licensing authorities
Controlling authorities
Drugs inspectors
Customs collectors
 Appointment of Drug Inspectors

 The Central and State Government can appoint Drug

Inspectors and to assign them definite areas.
 Any Person having financial interest in the import,
manufacturer, or sale of drugs or cosmetics cannot be
appointed as Drug Inspectors.
 Drug Inspectors are deemed to be public
servants.(sec.21IPC)
 The Central Government is free to prescribe
different qualifications of inspectors for
different purposes.
 The Central Government is free to prescribe
one set of qualifications for an inspector for
one purpose and another set of
qualifications for another purpose.
 Qualifications of Drug Inspectors
 A person must have a degree in Pharmacy or
Pharmaceutical Sciences or Medicine with Specialization
in Clinical Pharmacology or Microbiology from an Indian
University.
 For inspection of the manufacture of substances on
Schedule C the persons appointed as Drug Inspectors
must have (i) at least 18 month’s experience in the
manufacture of at least one of the substances specified
in Schedule C (ii) at least 18 months experience in
testing of at least one of the substances in Schedule C in
an approved testing laboratory (iii) gained experience of
not less than three years in inspection of firms
manufacturing any of the substances in Schedule C
during the tenure of their services as Drug Inspectors.
 Qualifications of Drug Inspectors
 For the purpose of inspection of manufacture of veterinary
biological products the person appointed as Drug
Inspectors should be (i) a graduate in veterinary
science/medical science/general science/pharmacy and
have at least 18 months experience in the manufacture
and testing of biological products.
 Provided that Drugs Inspectors who have gained
experience of at least 3 years in the inspection of firms
manufacturing any of the drugs specified in Schedule C,
shall be authorized to inspect the manufacture of veterinary
biological products.
 Powers of Drug Inspectors
 A Drug Inspector may within his local limits is empowered to
A. a. Inspect any premises where a drug or cosmetic is being
manufactured and means employed for standardizing and
testing the drug or cosmetic.

b. Inspect any premises where any drug or cosmetic is

being sold, or stocked or exhibited or offered for sale or
distributed.

 Mohali drug inspector moves court against Fortis Hospital for

dispensing drug after expiry date
(See more at: http://indianexpress.com/article/cities/chandigarh/mohali-drug-inspector-moves-court-against-fortis-hospital-for-
dispensing-drug-after-expiry-date/#sthash.jUapGgga.dpuf)
B. a. Take samples of any drug or cosmetic
which is being manufactured or being
sold/stocked/exhibited/offered for sale or
being distributed.
b. Take samples of drugs or cosmetics
from any person conveying/delivering or
preparing to deliver such drug or cosmetic
to a purchaser or a consignee.
 Powers of Drug Inspectors

C. At all reasonable times, with necessary assistance, if

required

i. Search any person :in respect of which an offence is related to

manufacture, sale or distribution has been or is being committed.

ii. Enter and search any place in which he has reason to believe that
offence related to manufacture, sale or distribution of drugs or
cosmetics has been or is being committed.

iii. Stop and search any vehicle, vessel or other conveyance being
used for carrying any drug or cosmetic in respect of which an
offence
 Powers of Drug Inspectors
iv. Examine any record, register document or any other material
object with any person or in any place mentioned above in (iii)
and seize the same if it likely to furnish the evidence of an
offence.
v. Require any person to produce any record, register, or other
document relating to manufacture, sale or distribution of any
drug or cosmetic in respect of which an offence has been or is
being committed.
vi. Exercise such other powers as may be necessary for carrying
out the purpose of the Act.
Every record or register or other document seized or produced
shall be returned to the person from whom it is seized or who
produce, within a period of 20 days of seizure or production,
after copies thereof or extracts there from certified by that
person.
A person who is willfully obstructing the Inspector in the exercise
of the powers conferred upon him, the person shall be
punishable with imprisonment extending up to 3 years or with
fine or both.
 Duties of Drug Inspectors
A. Inspection of Premises licensed for sale:
i. Inspect not less than twice a year all establishments licensed
for the sale of drugs within the area assigned to him and to
satisfy with the conditions of the license.
ii.Procure and send for test or analysis, if necessary, imported
packages which he has reason to suspect contain drugs
being sold in contravention of the provisions of the Act
iii.To investigate any complaint made to him in writing and to
institute prosecution in respect of breach of the Act.
iv.To maintain a record of all inspections made and action
taken by him in the performance of his duties, including
taking of samples and seizure of stocks and submit copies of
the such records to controlling authority
 Duties of Drug Inspectors
v. To make such enquiries and inspections as may be necessary to detect the
sale or drugs in contravention of the Act.

vi. When authorized by the government to obtain imported packages which he

has reason to suspect contain drugs the import of which is prohibited.

B. Inspection of Manufacture of drugs:

i. To inspect not less than twice a year, all the premises licensed for the
manufacture of drugs within the area allotted to him and to satisfy
himself with the condition of the license and the provisions of the Act.

ii. In case of establishments licensed to manufacture products specified in

Schedules C and C1 to inspect plant and the process of manufacture,
the means employed for standardizing and testing the drug, the methods
and place of storage, technical qualifications of the staff employed and
all details of location, construction and administration of the
establishment likely to effect the potency or purity of the product.
 Duties of Drug Inspectors

iii. To send to the controlling authority the report of

inspections carried out and whether conditions of the Act
are met or not by the manufacturer.
iv. To take the samples of the drugs manufactured on the
premises and send them for test or analysis.
v. To institute prosecutions in respect of the breach of the
Act and Rules.
 Procedure for Drug Inspectors
1. Fair price -written acknowledgement for the same.
2. Inform the purpose of taking the sample
3. Each portion of sample is then sealed effectively and
suitably marked.
4. If the sample is taken from manufacturing premises, it
should be divided into three To four portions only.
5. The Inspector shall retain one portion: OTHER
a. To the Government Analyst for test or analysis.
b. To produce in the court during proceedings, if required.
c. To the manufacturer or distributor and directly not
involved in the activity of the same
Thank you