Professional Documents
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Drugs and Cosmetics Act 1940, Rule 1945 by Dr. Izhar Ahmad
Drugs and Cosmetics Act 1940, Rule 1945 by Dr. Izhar Ahmad
&
COSMETIC ACT
Under supervision
Dr Najeeb jahan Presented by
Lecturer Izhar ahmad
PG scholar
Nium Bangalore
Nium Bangalore
HISTORY
British misrule-Providing poor healthcare system to
Indian citizens
3
Extended to whole of India……
OBJECTIVES
To regulate the import, manufacture, distribution and sale of
drugs and cosmetics through licensing.
Act Rule
Chapter
Chapter 1 IVA
Drug Principle
Controller, officer of Phyto-
Director General ISM chemist
of health India
Government Pharmacognocist
Director of the Analyst
Central drugs
Laboratory
1 teacher in
1 teacher in Dravaguna
Ilmul-advia
1 teacher in
Gunapadam 4 person from
ASU
pharmacopeia
3 person from ASU 3 practitioner of committee
drugs industry ASU medicine
Drugs Consultative committee-DCC
It is also an Advisory Body consist of two representative central
government to be nominated by Government .
One representative of each state Government to be nominated by the
State Government.
Function
DCC to advise the Central Government, the State Governments and
the ASU-DTAB on any matter for the purpose of securing uniformity
throughout India in the administration of this Act in so far as it
relates to ASU drugs.
It shall meet when required.
It has power to regulate its own procedure
• Misbranded Drugs:-
If it is so coloured , coated, powdered or polished that damage is
concealed or if it is made to appear of better or greater therapeutic
valve.
If it is not labelled in the prescribed manner.
If its label or container or anything accompanying the drug bears any
statement, design or device which makes any false claim for the drug
or which is false or misleading in any particular
• Adulterated Drugs:-
If it consists, in whole or in part, of any filthy, putrid or decomposed
substance.
If it has been prepared, packed or stored under insanitary conditions
whereby it may have been contaminated with filth or whereby it may
have been rendered injurious to health
• Spurious Drugs:-
Qualification:
• All member should be Graduate in Pharmacy on Pharmaceutical Chemistry or in
Medicine with Specialization in Clinical pharmacology or microbiology.
• 5 year Experience in manufacture or testing of a drugs.
Duties:
• To inspect all establishments licensed for the sale of drugs within the area
assigned to him.
• To send for test or analysis.
• To investigate any complaint.
• To maintain a record of all inspections made by him.
• To maintain a record of action taking by him in the performance of his duties.
DRUG INSPECTOR:
Qualification:
Has degree in Ayurvedic or Siddha or Unani system or a
degree in Ayurveda Pharmacy, as the case may be, conferred by
a University or a State Government or a Statutory Faculty,
Council or Board of Indian Systems of Medicine recognized by
the Central Government or the State Government.
Has a diploma in Ayurveda, Siddha or Unani System, as the
case may be, granted by a State Government or an Institution
recognized by the Central Government or a State Government
for this purpose).
Who have not less than 18 months’ experience in testing of at
least one of the substances in Schedule C in a laboratory
approved for this purpose by the licensing authority.
Who have gained experience of not less than three years in the
inspection of firm manufacturing any of the substances
specified in Schedule C
Function:
1. Inspection of all area where the drug and
cosmetics are being manufactured/sold/stocked.
2. Take sample of any drug and cosmetic are being
manufactured/sold/stocked
MANUFACTURE FOR SALE OF ASU DRUGS-
PART XVI
• 151-Manufacutre on more than one set of premises
• 152-Licensing Authorities state govt appoint such
authorities
• 153-Application for license to manufacture ASU drugs
FORM 24-D(100Rs)
• 153A-Loan license FORM 25-E(600)
• 154-Form of license to manufacture ASU drugs
• FORM 25-D
• 154A-Form of loan license to manufacture of ASU drugs
FORM 25-E
[FORM 25D (See rule 154)
1 2 3 4 5 6
Published Proof of
literature effectivenes
s
1 ASU Drugs, As per text As per Not Required Not required
given in text required
158B
Any change As per text As per Not Required Not required
in dosage text required
from of ASU
2 drugs
described
in section
3a
ASU drugs As per text New Not If required Required
referred in required
3a to be
3 used for
new
indication
S.no Category Ingredien Indicatio Safety Evidence/Experience of
t n study effectiveness
1 2 3 4 5 6
Published Proof of
literature effectiveness
“J” List of diseases and ailments that drug should not claim to cure
44
“O” Standards for disinfectant fluids
TYPE CONTENT