Drugs Inspector – Qualification, Power, Duties

Drugs Inspector – Qualification, Power, Duties

Qualification

1       Persons having qualification for
appointment as government, as Governmental Analysis for allopathic drugs; or

2        
having
a degree in ayurveda, siddha or unani system and not less than three years
of  post-graduate experience in the
analysis of drugs in a laboratory under control of (a) a government analyst, or
(b) a chemical examiner, or (c) head of an institution specially approved for
this purpose.

 

Power:

a) Inspect, —

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

(ii) Any premises where in any drug or cosmetic is being
sold, or stocked or exhibited or offered for sale, or distributed;

Take samples of any drug or cosmetic,–

(i) Which is being manufactured or being sold or is stocked
or exhibited or offered for sale, or is being distributed;

(ii) 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.

Appointed by Central and State Governments.

He should be a person with out any financial interest in the
import, manufacture or sale of drugs or cosmetics.

They are deemed as public servants and are officially
subordinate to the Controlling Authority.

Qualifications

For appointment as DI, person must have a degree in
Pharmacy/Pharmaceutical Chemistry/Medicine with specialization in Clinical
Pharmacology/Microbiology from a recognized University;

For inspection of manufactured substances in Schedule C, the
DI must have 1) at least 18 months experience in manufacture of at least one of
the substance specified in schedule C 2) at least 18 month experience in
testing one of the item in schedule C 3) 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

Powers of DI

He can Inspect

·        
any premises wherein any drug or cosmetic is
being manufactured and the means employed for standardizing and testing the
drug or cosmetic;

·        
any premises wherein any drug or cosmetic is
being sold, or stocked or exhibited or offered for sale, or distributed ;

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;

At all reasonable times with necessary assistance

search any person, who, he has reason to believe, has
secreted about his person, any drug or cosmetic in respect of which an offence
relating to manufacture sale or distribution has been, or is being, committed;
or

q  enter
and search 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; or

q   stop and search any 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 the drug or cosmetic not to
dispose of any stock that of for a specified period not exceeding 20 days or,
unless the alleged offence is such that the defect may be removed by the
possessor of the drug or cosmetic, seize the stock of such drug or cosmetic and
any substance or article by means of which the offence has been ,or is being,
committed

q   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

q   require any person to produce any record,
register, or other document relating to the manufacture for sale or for
distribution of any drug or cosmetic with respect to which an offence has been
committed

q  exercise
such other powers as may be necessary for carrying out the purposes of the Acts
or Rules.

Duties of Inspectors

A) Inspection of premises licensed for sale:

§  Inspect
NLT twice an year all establishments licensed for sale of drugs within the area
assigned to him and to satisfy himself that the conditions of license are being
observed.

§  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 Controlling Authority

§  To
make enquiries and inspections as may be necessary to detect sale of drugs in
contravention to the Act.

§  When
so authorized by State Governments to obtain imported packages which he has
reason to suspect to contain drugs whose import is prohibited.

B) Inspection of Manufacture of Drugs

Ø  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.

Ø  In
establishments licensed to manufacture products specified 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.

Ø  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.

Ø  To
take samples of drugs manufactured on premises & send them for test or analysis.

Ø  To
institute prosecutions in respect of breaches of Act and Rules.

Procedure for Drug Inspectors

Ø  An
Inspector taking any samples must pay its fair price & may require written
acknowledgement for the same. If price tendered is refused or when Inspector
seizes any stock of any drug or cosmetic, he should issue the receipt for the
same in prescribed form. (Form 16)

Ø  He
should inform the concerned person, the purpose of taking the sample in form 17
& divide the sample to four parts In his presence. Each portion is then
sealed & suitably marked. The person from whom the sample is taken must
also be allowed to add his mark of seal on the packet. If sample taken from a
manufacturing premises, it should be divided to three portions only.

Ø  The
sample if made into small volume is likely to deteriorate, Inspector can take
three or more containers when necessary after suitably marking it.

Ø  One
portion of sample is to be restored to the person, second part send to
Government analyst and third one is preserved for production before the court,
if required & fourth is sent to warrantor if any.

Ø  Inspector
should sent sample to Government Analyst by registered post or by hand in
sealed packet enclosed together with memorandum in Form 18 in an outer cover
addressed to Government analyst.

Ø  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.

Ø  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.

Ø  Any
record, register or any other document sized by the Inspector should be
returned to the persons from whom they where seized or who produce the same
within a period of 20 days of such seizure or produce.

Ø  When
an Inspector seizes any record, register or document, or any other material
object, he should as soon as inform the same to the judicial magistrate &
take his orders to the custody thereof.

Ø  Every
person for time being in charge of any premises where any drug or cosmetic is
manufactured or is kept for sale or distribution, on being required by the
Inspector is legally bound to disclose to the inspector the place where drug or
cosmetic is being manufactured or kept.

Ø  Willfully
obstructing the Inspector or refusing to provide any record or register is
punishable with imprisonment up to three years, or with fine or both.