The Drug Inspectors are appointed both by State Government and Central Government for specific areas or for specific category of activity.
Inspector
The
Drug Inspectors are appointed both by State Government and Central Government
for specific areas or for specific category of activity. There could be a set
of inspectors exclusively for the manufacturing of drug formulations. Drug
Inspector works under the Drug Controlling Authority under State Government or
Central Government as the case may be. An inspector has been charged with the
responsibility of ensuring strict implementation of Drugs and Cosmetics Act in
the area of his/her. jurisdiction.
The person should
not have direct or indirect financial interest in any of the activities
concerned with import, manufacturing, sale or distribution of drugs.
A graduate in
pharmacy or pharmaceutical sciences or medicine with specialization in clinical
pharmacology or microbiology from a University established in India, is
eligible for the post of Inspector.
For the purpose of
Schedules C and C (1) drugs, (i) a drug inspector with atleast 18 months of
experience in manufacturing of atleast one substance specified in Schedules C
and C (1) or (ii) a drug inspector with atleast 3 years experience in
inspecting the firms manufacturing Schedules C and C (1) drugs or (iii) a drug
inspector with minimum of 18 months experience in testing of atleast one ofthe
substances in schedules C and C (1) in a laboratory approved for the purpose.
The
requirement of these qualifications shall not, however, apply to those persons
appointed as Inspector on or before 18th October, 1993.
Every Inspector
shall be deemed to be a public servant under Section 21 of the Indian Penal
code.
Subject
to instructions of Controlling Authority, it shall be the duty of an Inspector
authorised to inspect premises licensed for the sale of drugs.
(i) to inspect, not less than once a year, all establishment
for sale.
(ii) to satisfy himself that conditions of licences are
being observed.
(iii) to procure and
send the drug for test or analysis if he has reason to suspect that drug is
sold or stocked in contravention with provisions of the Act or Rules.
(iv) to investigate complaint in writing.
(v) to maintain a record of inspections.
(vi) to make necessary enquiries.
(vii) to institute
prosecutions in respect of breaches of the Act and Rules.
(viii) when
authorized by the State Government, to detain imported packages which he has
reason to believe contain drugs, the import of which is prohibited.
Subject to
instructions of Controlling Authority, the following duties are performed:
(i) to inspect, not
less than once a year, all premises licenced for manufacture of drugs or
cosmetics
(ii) to satisfy himself that conditions of licence are fulfi
lIed.
(iii)
to inspect plant, process of manufacture and standardization, storage,
technical qualifications and other details for Schedules C and C (1) drugs.
(iv) to send
detailed inspection report to Controlling Authority.
(v) to take samples for test or analysis in accordance with
Rules.
The Inspector,
except for official business or when required by law, shall not disclose any
information acquired by him.
If
he has sufficient reasons to believe that violation of provisions of DCA is
taking place, he/she may and seize records or ask the manufacturer not to sell
the drugs for a period of 20 days.
Drug Inspector if
required may take the xerox copies of the seized documents signed by the owner
of the documents.
Drug Inspector is
supposed to carry a routine inspection atleast once in a year of a shop or a
manufacturing unit within his area. The inspection should be generally carried
out at reasonable time preferably during working hours. However ifhe/she has
sufficient reasons to believe that contravention ofthe provision of DCA is
taking place he/she accompanied by sufficient force may raid the premises and
seize the documents, records or the medicines as the case may be.
The
sample withdrawn or seized from drug store should be divided into 4 parts. The
seizure of medicine should be carried out in accordance with the Code of
Criminal Procedure, 1898 in presence of witnesses. The samples should be sealed
and the seal of drug store owner should also be allowed. In case of
injectables, 4 different ampoules of same batch are seized. The payment of fair
price of seized material is made to the drugs store owner or in case of refusal
for accepting money, the receipt is prepared by Drug Inspector separately and
the form is filled up. Any action of seizure or raid is required to be informed
to Judicial Magistrate of that area immediately. Out of 4 samples confiscated,
one is retained by the Inspector, one is sent to Government analyst, one is
given back to drugs store owner and 4th sample is sent to the manufacturer.
The
sample sent by an Inspector to Government Analyst shall be by registered post
or by hand in sealed packet enclosed with memorandum in Form 18 in an outer
cover addressed to the Government Analyst. A copy of memorandum and a specimen
impression of seal is sent separately to the Government Analyst by registered
post.
In
case of raid or seizure of medicine at manufacturing unit, 3 seized samples are
prepared following same procedure. One sample is retained by the Inspector for
producing in court. The second sample is handed over to manufacturer and 3rd
sample is sent for analysis to Government Analyst.
After
receipt of report of analysis, action is taken accordingly. If the report is
satisfactory, regular sale is allowed. If it is not satisfactory, further legal
action is taken up.
Any
physical assault or a threat in writing or on telephone to Inspector while, he
is discharging his duties is considered as an offence punishable with
imprisonment upto 3 years or fine or both.
Form 15 - It is an order
given by Inspector requiring a person not to dispose of any stock in his
possession.
Form 16 - It is the receipt the Inspector
tenders for the seized material.
Form 17 - It is the intimation to the person
from whom sample is taken.
Form 17-A - It is receipts of samples of drugs/cosmetics
taken where fair price is tendered.
Form 18 - It is the
memorandum to be sent by Drug Inspector to Government analyst for the purpose
of analysis of seized formulation.
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