Adminstration of act and rules

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ADMINSTRATION OF ACT AND RULES
Drugs and cosmetics act and rules
Advisory Analytical Executive

GOVERNMENT ANALYST
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.

GRADUATE in medicine/science/pharmacy/pharmaceutical
chemistry of recognized University and have 5 yrs experience in
testing of drugs in a laboratory under the control of -
1) a Government Analyst
2) head of approved Institution or testing laboratory.
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
2) head of approved Institution or testing laboratory.
QUALIFICATIONS 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.
AGNIFIER
DUTIES OF GOVERNMENT ANALYST

PROCEDURE
Sample is
collected from
inspectors or
other persons
Compare the seals on the
package with the specimen
seals and note its condition
On completion
of test, reports in
triplicate
together with full
protocols of the
tests or analysis
should be sent to
the Investigator.

DRUGS INSPECTORS
Appointed by Central and State Governments
They are deemed as public servants and are
officially subordinate to the Controlling Authority.
He should be a person with out any financial
interest in the import, manufacture or sale of
drugs or cosmetics

• Person must have a degree in
Pharmacy/Pharmaceutical
Chemistry/Medicine with specialization in
Clinical Pharmacology/Microbiology from a
recognized Indian University.
• For inspection of manufacture of substances in
Schedule C
1) 18 months experience in manufacture/ testing
of at least one of the substance specified in
schedule C
2) Gained experience of NLT 3 yrs in inspection
of firms manufacturing any of the substances of
Schedule C during their tenure as services as DI
QUALIFICATIONS OF DI

POWER OF DI
• Any premises wherein any drug or cosmetic is-
1.manufactured and the means employed for standardizing and
testing.
2.Sold,stocked ,exhibited or offered for sale, or distributed.
INSPECT
• Any drug or cosmetic-
1. which is being manufactured ,stocked ,exhibited , sold, offered
for sale, or is being distributed;
2. 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
COLLECTION OF SAMPLES
• Any place in which he has reason to believe an offence relating to
manufacture, sale or distribution of drugs or cosmetics has been, or is
being committed;
ENTER & SEARCH

• Vehicle, Vessel, or other conveyance which, he has reason to
believe, is being used for carrying any drug or cosmetic in respect
of which an offence has been, or is being, committed and order
in writing the person in possession of not to dispose of any stock
that of for a specified period not exceeding 20 days.
STOP & SEARCH
• Examine any record, register, document or any other material
object with any person or in any place mentioned above and
seize the same if it is likely to furnish the evidence as an offence.
EXAMINE DATA

DUTIES OF INSPECTORSInspectforpremises
licensedforsale
• Inspect NLT twice an year all establishments licensed for sale of
drugs within the area assigned to him
• Procure and send for tests or analysis, if he has reason to think
that the drugs are sold in contravention of provisions of Acts or
Rules.
• To investigate any complaints made to him in writing & to
institute prosecutions in respect to the breaches of the act.
• To maintain all records of inspections made & actions taken by
him including taking of samples and seizure of stocks & to submit
copies of such records to the CA.
• Make enquiries such inspections as may be necessary to detect
sale of drugs in contravention to the Act.
• When so authorized by State Governments to detain imported
packages which he has reason to suspect to contain drugs whose
import is prohibited.

Inspectfor
manufactureofdrugs
• Inspect NLT twice a year all premises licensed for the
manufacture of drugs within the area allotted to him and satisfy
himself that the condition of license and provisions of Acts and
Rules are observed.
• In establishments licensed to manufacture products specifies in
Schedule C and C1 inspect the process of manufacture, means
employed for standardizing and testing of drugs, methods & place
of storage, technical qualifications of staff employed & all details
of location, construction & administration of establishment likely
to affect the potency or purity of drug.
• To send controlling authority after each inspection a detailed
report indicating conditions of license & provisions of Acts &
Rules which are being observed & which are being not observed.
• To take samples of drugs manufactured on premises & send
them for test or analysis.

Procedure :-
Collection of sample and pay its fair price, if
refused then issue the receipt(form 19) and inform
the concern (Form 17)
*Each portion is then sealed & suitably marked.
Government
analyst
Warrantor Presenting
before the court
Restored
by person
Inspector should sent sample to Government Analyst by registered post or by hand in
sealed packet enclosed together with memorandum in( Form 18)

• Case 1
If the confiscated drug is not of standard quality, it should be
reported to court accordingly & court may order destruction
of drug under the supervision of Inspector in presence of
such authority that the court may prescribe.
• Case 2
If confiscated drug is of standard quality, Inspector may
report court accordingly and court may order sale of drugs by
public auction to any party holding a requisite license and
documents or records should be registered within 20 days.

• Reference
The drugs and cosmetics act and rules, Textbook of Forensic
Pharmacy. Author, N. K. Jain. Edition, 6. Publisher, Vallabh
Prakashan, 2003. ISBN, 8185731152, 9788185731155 ; pg no
148-157

Adminstration of act and rules

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