Discuss the qualification and Duties of Drug Inspector In relation to manufacture-
Answer:
Qualification of Drug Inspector:
A person who is appointed an Inspector should possess the following qualifications
1) Graduate in Pharmacy or Pharmaceutical Sciences or Medicine with specialization
in Clinical Pharmacology or Microbiology from a recognized University.
Provided that for the purpose of inspection of manufacture of substances specified in
Schedule C, a person appointed as a Drug Inspector should have -
i)Not less than 18 months experience in the manufacture of at least one of the substances
specified in Schedule C, or
ii) Not less than 18 months experience in testing of at least one of the substances in
Schedule C in a approved Laboratory, or
iii)Not less than three years experience in the inspection of firms manufacturing any of
the substances specified in Schedule C during the course of their services as Drugs
Inspector.
Provided further that the first 4 years from the date on which Chapter IV of the Act
takes effect in the States, person whose qualification, training & experience are considered adequate may be appointed as Inspector & their appointments continued
even after 4 years, if the State Govt. is satisfied.
Duties of Drug Inspectors in relation to sale of drugs and cosmetics1) To inspect at least twice a year all establishments licensed for sale of drugs in the
area assigned to him and to check whether the conditions of the licenses are observed
or not.
2) If he thinks necessary, to obtain and send the samples of imported drugs and
cosmetics for test or analysis, which are being sold or stocked in contravention of the
provisions of the Act.
3) To investigate any complaint in writing made to him.
4) To institute prosecutions in case of breach of the Act and Rules.
5) To maintain the records relating to all inspections and actions taken by him and to
submit copies of such records to the controlling authority.
6) To make inquiries and inspections regarding the sale of drugs in contravention of the
provisions of the Act.
7) To detain the imported packages, if he suspects to contain drugs, the import of which
is prohibited.
Duties of Drug Inspector in relation to manufacture of drugs and cosmetics.
Duties of Drug Inspector in relation to manufacture of D&C Act,1940
1)To inspect at least twice a year, all premises licenced for manufacturing of drugs
within the area allotted to him & to satisfy whether the conditions of licence &
provisions of the act and rules thereunder are being observed or not.
2) To inspect premises licenced for manufacture of drugs, specified in Schedule-C &
C(1) & to observe process of manufacturing, means employed for standardization &
testing of drug & storage conditions & qualification of technical staff and employee &
all other details of location, construction, administration of establishment, other things
which may likely to affect potency & purity of the product.
3) To send after each inspection a detailed report of inspection to the controlling
authority with which conditions of licence and provisions of the act & the rules
thereunder being observed and which being not observed.
4) To take sample of drugs manufactured in the premises and sent them for test or
analysis.
5) To check all the records & registers required to be maintained under the rules.
6) To institute prosecutions, in respect of breach of the act and rules.
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