Overview of Drugs and Cosmetics Act, 1940
Drugs and
Cosmetics
Act
1940
1
Con
t
ents
•
Introduction
•
History and
Objectives
•
Definitions
•
Administration
of the
act
and
rules
•
Provisions
related
to
Import
•
Provisions
related
to
Manufacture
•
Provisions
related
to
Sale
•
Labeling and
Packaging
•
Schedules to
the act and
rules
INTRO
D
U
C
TION
•
CHAPTER
I
INTRODUCTORY
•
CHAPTER
II
THE DRUGS TECHNICAL
ADVISORY
BOARD, THE CENTRAL
DRUGS
LABORTORY
AND
THE DRUGS
CONSULTATIVE
COMMITTEE
•
CHAPTER
III
IMPORT
OF
DRUGS AND
COSMETICS
•
CHAPTER
IV
MANUFACTURE,
SALE AND DISTRIBUTION
OF
DRUGS
AND
COSMETICS
3
•
CHAPTER
IVA
PROVISIONS
RELATING
TO
AYURVEDIC
SIDDHA
AND
UNANI
DRUGS
•
CHAPTER
V
MISCELLANEOUS
4
5
History
•
British
misrule-Providing
poor healthcare system to Indian
citizens
•
Observations
made
by-Drugs Enquiry
Committee,
Indian Medical
Association
•
Reports in- Indian Medical Gazette during
1920-30
•
1940 –
Drugs
and
Cosmetics
Act
•
1945
– Rules under the Act
Extended to whole of
India
……
6
Objectives
•
To
regulate the
import,
manufacture,
distribution
and
sale
of drugs
&
cosmetics
through
licensing.
•
Manufacture, distribution and
sale
of drugs and
cosmetics
by
qualified persons
only
.
•
T
o
p
r
e
vent
s
u
b
s
t
a
n
da
r
d
i
n
d
rug
s
,
p
r
e
s
u
m
ably
for
m
a
i
nta
i
n
i
ng
h
i
g
h
s
t
a
n
d
ar
ds
of
medical
treatment.
•
To
regulate the manufacture and
sale
of
Ayurvedic,
Siddha and Unani
drugs.
•
To
establish
Drugs
Technical
Advisory
Board(DTAB)
and
Drugs
Consultative
Committees(DCC)
for Allopathic and allied drugs and
cosmetics.
7
The salient
features
of the Drugs & Cosmetics
Act,
1940
are
as
follows:
a)
Maximum
penalty
life imprisonment
and fine of Rs. 10 lakhs or 3
times
the
value
of the confiscated goods, whichever is
more.
b)
Some
of the
offences
cognizable and
non-bailable.
c)
Besides officers
from the Drug
Controller’s Office,
other gazette
officers
also
authorized to launch prosecution under the
Act;
d)
Specially designated courts for
trial
of
offences
covered under the
Act;
e)
Provision for compounding of
minor
offences.
8
Definitions
Drugs
:
All
medicines for internal
or
external
use
of human beings or animals and
all
substances intended to
be
used for or
in
the
diagnosis,
treatment,
mitigation
or
prevention
of any disease or disorder
in human
beings or
animals.
9
Cosmetic
:
Any
article intended to
be
rubbed,
poured,
sprinkled
or sprayed
on
,
or
otherwise applied to, the human
body or
any part thereof for
cleansing, beautifying, promoting attractiveness,
or
altering the
appearance, and includes any
article
intended for
use
as
a component
of
cosmetic.
10
Misbranded drugs
:
a)
if it is
so
coloured,
coated,
powdered
or
polished
that
damage is
concealed
b)
if it is
not labelled
in
the prescribed
manner;
or
c)
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.
11
Adulterated drug
:
(a)
if
it
consists,
in
whole
or
in
part,
of
any
filthy,
putrid
or
decomposed
substance;
or
(b)
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
;
or
(c)
if
its container
is
composed
in
whole
or
in
part, of any
poisonous
or
deleterious
substance
which
may
render the contents injurious
to
health.
12
Spurious drugs
:
(a)
if it is
imported
under a
name
which belongs
to
another drug;
or
(b)
if
it is
an
imitation
of,
or
a
substitute
for,
another drug or resembles another drug
in
a
manner likely to
deceive or
bears
upon
it or upon its label
or
container the
name
of another
drug.
or
(c)
if it
has been
substituted
wholly
or
in
part
by another drug or
substance.
13
Manufacture
:
In relation
to
any drug
or
cosmetic, it includes
any
process or
part
of
a
process for
making, altering, ornamenting, finishing, packing, labelling,
breaking
up
or
otherwise
treating
or
adopting
any
drug
or
cosmetic
with a
view
to
its sale
or
distribution
but
does
not
include the compounding or dispensing of any
drug.
14
Patent or
Proprietary
medicine
:
A drug
which is
a remedy
or prescription presented
in
a form
ready for internal
or
external
administration
of
human
beings or animals and which
is
not included in
the
edition
of
the
Indian
Pharmacopoeia
for
the
time
being
or
any
other
Pharmacopoeia authorized
in
this behalf by the Central
Government.
15
Administration
of
the
act
and
rules
A)
Advisory
:
1)
Drugs
Technical
Advisory
Board-DTAB
2)Drugs Consultative
Committee-D.C.C.
B)
Analytical
:
1)
Central Drugs Laboratory - CDL
2)Drug Control Laboratory in
states
3)Government
Analysts
C)
Executives
:
1)
Licensing
authorities
2)
Controlling authorities
3)Drug
Inspectors
16
Drugs
Technical
Advisory
Board(DTAB)
Ex-Officio
:
(i)
Director General of Health Services
(Chairman)
(ii)
Drugs
Controller,
India
(iii)
Director of the Central
Drugs
Laboratory,
Calcutta
(iv)
Director of the Central Research Institute, Kasauli
(v)Director of Indian
Veterinary
Research Institute,
Izatnagar
(vi)
President of Medical Council of
India
(vii)
President of the Pharmacy Council of India
(viii)Director
of Central
Drug
Research Institute,
Lucknow
17
Nominated:
1)
Two
persons
by the
Central Government
from among
persons who
are
in
charge
of drugs control
in
the
States
2)
One
person by the Central Government from the
pharmaceutical
industry
3)
Two
persons holding
the
appointment of
Government Analyst
under
this
Act, to
be
nominated
by the Central
Government
18
Elect
e
d:
1)
one
person,
to
be
elected
by
the Executive Committee of the
Pharmacy
Council
of
India
, from
among
teachers
in
pharmacy
or
pharmaceutical chemistry
or
pharmacognosy on the
staff
of
an
Indian university or a college
affiliated.
2)
one
person,
to
be
elected
by
the Executive Committee of the
Medical
Council
of
India
,
from
among
teachers
in
medicine or therapeutics on
the
staff
of
an
Indian
university or a college
affiliated.
3)
one
pharmacologist
to
be
elected
by
the
Governing
Body
of
the
Indian
Council
of Medical
Research.
4)
one
person
to
be
elected
by the
Central Council of the
Indian Medical
Association
.
5)
one
person
to
be
elected
by
the
Council
of
the
Indian
Pharmaceutical
Association
.
19
Functions:
T
o
adv
i
se
t
he
C
e
n
t
ral
G
o
v
e
r
n
m
ent
a
n
d
t
he
S
t
a
t
e
G
o
v
e
r
n
m
ents
o
n
t
echn
i
cal
matters
arising
out
of the
administration
of this
Act.
To
carry
out
the other functions assigned
to it
by this
Act.
(The
nominated and elected members of the Board
shall
hold
office
for
three
years
,
but
shall
be eligible for
re-nomination
and
re-election)
20
Drugs
Consultative
Committee(DCC)
•
It
is also an
advisory body
constituted by central
government.
•
Constitution:
Two
representatives of the
Central
Government
One
representative
of
each
State
Government
21
Functions:
To
advise
the
Central
Government,
the
State Governments
and
the
Drugs
Technical
Advisory Board on any other
matter
tending to secure
uniformity
throughout
India
in
the
administration
of this
Act.
The
Drugs
Consultative
Committee
shall
meet
when
required
Has power
to
regulate
its
own
procedure.
22
Central Drug
Laboratory(CDL)
•
Established in
Calcutta
, under the control
of a
director appointed
by
the
Central
Government
Funct
i
o
n
s
:
•
Analysis
or
test
of samples
of
drugs/cosmetics sent
by
the custom collectors
or
courts.
•
Analytical
Q.C.
of the
imported
samples.
•
Collection,
storage and distribution of
internal
standards.
•
Preparation
of
reference
standards
and their
maintenance.
•
Maintenance of
microbial
cultures.
•
Any other duties
entrusted by Central
Government.
•
Acting
as an
appellate authority
in matter
of
disputes.
23
Import
of
Drugs
•
Classes of drugs
prohibited
to
import
•
Import of drug under
license
1)Specified
in
Schedule-X
2)Any new
drugs
•
Drugs exempted
from
provisions
of
import
•
Offences and
Penalties
24
Classes
Of
Drugs
Prohibited
To
Import
•
Misbranded
drugs
•
Drugs
of
substandard
quality
•
Drugs
claiming to
cure diseases
specified
in
Sch-J
•
Adulterated
drugs
•
Spurious
drugs
•
Drugs
whose manufacture,
sale/distribution
are
prohibited
in original country
,
except for the
purpose
of
test, examination
and
analysis.
•
Patent/Proprietary
medicines
whose true
formula is
not
disclosed.
25
Import
of
the
biological
drugs(C/C
1
)
Conditions
to be
fulfilled
:
•
Licensee
must
have adequate
facility
for the
storage.
•
Licensee
must maintain
a
record
of the sale,
showing
the
particulars of the
names
of drugs and of the persons
to
whom
they have been
sold.
•
Licensee
must
allow an inspector to inspect
premises
and
to
check the
records.
•
Licensee
must
furnish the sample
to
the
authority.
Import
of
the
Schedule-X
drugs
(Narcotic
&
Psychotropic
drugs)
26
Conditions to
be
fulfilled:
•
Licensee
must
have,adequate
storage
facility.
•
Applicant
must
be
reputable
in
the occupation, trade
or
business.
•
The license
granted ever
before should
not be suspended or
cancelled.
27
Drugs Imported for examination, test
or
analysis
Conditions to
be
fulfilled:
•
License
is
necessary under
form-11
•
Must use
imported drugs
only
for
said
purpose
and at the place specified in the
license.
•
Must
keep
the
record
with
respect
to
quantities, name of the manufacturer and
date
of
import.
•
Must
allow an inspector
to
inspect the
premises
and check the
records
.
28
Import
of
cosmetics
Cosmetics
prohibited
to
import
:
•
Misbranded
cosmetics
•
Spurious
cosmetics
•
Cosmetic
containing
harmful
ingredients
•
Cosmetics
not of standard
quality
•
which contains
more
than-2
ppm
Arsenic
, 20
ppm
lead,
100 ppm
heavy
metals
Penalties
related
to
Import
OFFENCES
Import of spurious
OR
adulterated drug
OR
drug which involves risk
to
human
beings
or
animals
OR
drug
not
having
therapeutic
values
29
PENALTIES
a)
3
y
e
a
r
s
i
m
pr
i
so
n
m
e
n
t
a
n
d
5000
R
s.
fine on first
conviction
b)
5
years imprisonment
OR
1000 Rs.
fine
OR both
for
subsequent
conviction
Contravention of the
provision
a)
6
m
o
n
t
hs
i
m
p
r
i
s
o
n
m
ent
O
R
5
00
R
s
.
fine
OR
both for first
conviction
b)
1
year imprisonment
OR
1000 Rs. fine
for subsequent
offence
30
Prohibition
of
manufacture
•
Drug not
of standard quality or
misbranded, adulterated or
spurious.
•
Patent or
Proprietary
medicine.
•
Drugs
which
claims
to
cure diseases specified
in
Sch-J.
•
Drugs
which
Risky
to
human
beings
or
animals.
•
Drugs
without therapeutic
value.
31
Types
of manufacturing
license
Allopathic
Drugs
Other than
Sch.-
C/C1
&
X
Sch.-
C/C1
But
not
-X
Sch.-X
Sch.-C/C1
&
X
Drugs for the
purpose of
examination
test
or
analysis
Own
P
r
e
m
ises
Own
Pre
m
is
e
s
Own
Premises
Loan
License
R
e
pac
k
ing
license
32
Manuf.
of
drugs
other
than
in
Sch-C/C
1
Conditions:
•
Premises
should
comply
with
schedule
‘M’.
•
Adequate
facility
for
testing
, separate from
manufacturing.
•
Adequate
storage
facility.
•
Records
of
mfg.
&
testing-maintained
for
at least
2 years from date of
Exp.
•
License should provide
sample to
authority.
•
Furnish
data of
stability.
•
Maintain
the
inspection
book.
•
Maintain
reference
samples
from
each
batch.
•
Accounts
of
production
recorded
&
maintained for
5
years
or 1
year after
Expiry.
33
Manufacture
Of Sch-X
drugs
Conditions:
•
Have to sent
invoice of sale
to licensing authority every 3
months
•
Store
drugs in
direct
custody
of
responsible
person.
•
Preparation
must
be labeled with
XRx
•
Marketed in packing
not
exceeding
•
100 unit dose
–Tablets/Capsules
•
300
ml-
Oral
liquid
•
5
ml
-
Injection
34
Manuf.
of
drugs those in
Schedule-
C/C
1
(Biological
)
Conditions:
•
Drugs
must
be issued
in
previously
sterilized
sealed glass
or suitable
container
•
Containers should
comply
with req. of
Sch-F/F1
•
Drug
must comply
with std.
(quality, purity,
strength) specified
in
sch.-F
•
Par
e
nt
e
ral
i
n
doses
o
f
1
0
m
l
o
r
m
or
e
s
hou
l
d
b
e
t
e
s
t
ed
f
or
f
r
e
e
d
o
m
f
r
om
Pyrogens
•
Separate lab. for
culture
&
manipulation
of
spore
bearing
Pathogens
•
Test
for sterility
should be carried
out.
Penalties
related
to
Manufacture
35
36
Loan
License
Definition
:
A
person(applicant) who
does not
have
his own
arrangements(factory)
for
manufacture
but
who wish to
avail the
manufacturing facilities
owned
by
another
licensee
.
Such licenses are
called
Loan
licenses.
Procedure:
Licence
is
obtained
from
licensing
authority
(FDA)
on
application
in
prescribed
forms (24-A , 27-A)
with prescribed fees (Rs.
6000,
1500).
37
Repackaging
license
Definition:
Process of
breaking
up
any drug
from
a
bulk container
into small
packages
and
labeling with a view
to
their
sale
and
distribution.
Repackaging of drugs
is
granted of
drugs
other than Schedule-C/C
1
and
X.
Procedure:
Licence
is
obtained from licensing
authority (FDA)
on application
in
prescribed
forms (24-B)
with prescribed fees (Rs.
500,
200).
TYPES OF
SALES
LICENCES
Allopathic
Drugs
Whole
Sale
Retail
Sale
Sales From
Motor
Vehicle
(
Vender)
General
Licence
R
e
stri
c
t
e
d
Licence
Drugs
other
than
sch.-
C
/
C
1
Drugs
in
Sch.-
C/C1
Drugs
in
Sch.-
X
For
Sch
.
-
C
/
3
C
8
1
39
Classes of drugs
prohibited
to
be
sold
•
Misbranded, spurious, adulterated and drugs
not
of standard
quality
•
Patent/Proprietary
drugs with undisclosed
formula
•
Sch-J
drugs
•
Expired
drugs.
40
Wholesale Of Biological
(C/C
1
)
•
Adequate
premises,
with
greater
than 10
M
2
area
,
with proper storage
facility
•
Drugs
sold
only to
retailer
having
license
•
Premises
should be
in charge
of
competent
person
who
is
Reg.
Pharmacist
.
•
Records
of purchase
&
sale
•
Records preserved for
3 years
from date of
sale
•
License should
displayed on
premises
41
Wholesale Of Other Than
Those
Specified In
C/C
1
And
X
•
All the conditions as discussed
in
for
biological.
•
Compounding
is
made
by
or
under
the
direct
and
personal
supervision
of
a
qualified
person.
42
Retail
sale
•
For
retail sale,
two
types
of licenses are
issued:
i)
General
licenses
ii)
Restricted
licenses
Restricted
license:
Granted
to
those dealers who do
not
engage the services of
a
qualified
person and
only deal
with such classes of
drugs whose sales
can
be
effected
without qualified person and vendors
who
do
not
have fixed
premises.
43
Labeling &
Packaging
•
All
the
general
and specific labeling and packaging specified to
all
classes
of
drugs and
cosmetics
should be
as
per the provisions
made
under the
act.
Schedules
to the
rules
44
TYPE
CO
N
T
E
NT
“A”
Performa
for
forms no. 1 to
50
(
Application, issue, renewal,
etc.)
“
B
”
Rates of fee
for
test
or analysis by CDL or Govt.
analysts
“
C
”
List
of
Biological
and
special
products
(Injectable)
applicable
to
special
provisions.
Ex. Sera,
Vaccines,
Penicillin…..etc
“C
1
”
List
o
f
B
i
o
l
ogi
c
al
a
nd
s
pec
i
al
pr
o
d
u
c
ts
(n
o
n
p
a
r
e
n
te
r
a
l
)
a
p
plic
a
ble
to
special
provisions.
Ex.
Digitalis,
Hormones ,
Ergot
“D”
List of drugs that are
exempted
from provisions of
import
“E
1
”
List of
poisonous substances under
the
Ayurvedic
,
Siddha
and
Unani
systems
“F”
Provisions applicable
to
blood
bank
Schedules
to
the
rules
45
TYPE
C
O
N
TENT
“F
1
”
S
p
ec
i
al
pr
o
v
is
i
o
n
a
ppl
i
c
a
ble
t
o
b
i
o
l
ogi
c
a
l
and
spe
c
i
a
l
pr
o
d
u
c
ts,
e
.
g
.
B
a
c
t
erial
a
nd
v
i
ral
vacc
i
n
e
s,
sera
from
l
i
v
i
ng
a
n
i
m
a
l
s,
bact
e
rial
or
i
g
i
n
diagnostic
agents
“F
2
”
Standards for
surgical
dressings
“F
3
”
Standards for
umbilical
tapes
“FF”
Standards for
ophthalmic
preparations
“G”
List
of
substances
required
to
be
used
under medical supervision
and
labelled
accordingly Ex.
Metformin,
Anti
Histaminic,
…etc.
“H”
List
of
substances
(prescription
)
that should
be
sold
by retail
only
on
prescriptions
of
R.M.P.
Ex. Atenolol, Lorazepam, Dapson
…etc.
Schedules
to the
rules
46
Schedules
to the
rules
TYPE
47
CO
N
T
E
NT
“P”
Life
period(expiry)
of drugs Ex. Insulin Inj. – 24
months
“Q”
Coal
tar colors
permitted
to be used in
cosmetics
Ex.
Caramel,
TiO2,
Toney
red…..
“
R
”
Standards for
mechanical
contraceptives
“R
1
”
Standards for
medical
devices
“S”
Standards for
cosmetics
“T”
Requirements (GMP) of factory
premises
for
Ayurvedic,
Siddha,
Unani
drugs
“U”
Manufacturing and
analytical
records of
drugs
Schedules to
the
rules
TYPE
48
C
O
N
TENT
“U
1
”
Manufacturing and
analytical
records of
cosmetics
“V”
Standards for
patent or
proprietary
medicine
s
“
W
”
List of drugs
marketed
under generic
names-
Omitted
“X”
List of
narcotic
drugs and
psychotropic
substances
EX.
Opium,
Morphine,
Barbital……
“Y”
Requirement and guidelines on
clinical trials
for
import and
manufacture
of new
drugs
49
The Drugs and Cosmetics Act of 1940 was enacted to regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India. The Act aims to ensure high standards of medical treatment, prevent substandard drugs, and establish advisory boards for different types of drugs. It sets out provisions related to import, manufacture, sale, labeling, and packaging of products, with stringent penalties for non-compliance. The history, objectives, key features, and definitions of the Act are outlined in detail.
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Presentation Transcript
Drugs and Cosmetics Act 1940 1
Contents Introduction History and Objectives Definitions Administration of the act and rules Provisions related to Import Provisions related to Manufacture Provisions related to Sale Labeling and Packaging Schedules to the act and rules
INTRODUCTION CHAPTER I INTRODUCTORY CHAPTER II THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORTORY AND COMMITTEE CHAPTER III IMPORT OF DRUGS ANDCOSMETICS CHAPTER IV MANUFACTURE, SALEAND DISTRIBUTION OF DRUGS AND COSMETICS THE DRUGS CONSULTATIVE 3
CHAPTER IVA PROVISIONS RELATING TO AYURVEDIC SIDDHA AND UNANI DRUGS CHAPTER V MISCELLANEOUS 4
History British misrule-Providing poor healthcare system to Indiancitizens Observations made by-Drugs Enquiry Committee, Indian MedicalAssociation Reports in- Indian Medical Gazette during1920-30 1940 Drugs and CosmeticsAct 1945 Rules under the Act Extended to whole ofIndia 5
Objectives To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing. Manufacture, distribution and sale of drugs and cosmetics by qualified personsonly. To prevent substandard in drugs, presumably for maintaining high standards of medical treatment. To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs. To establish Drugs Technical Advisory Board(DTAB) and Drugs Consultative Committees(DCC) for Allopathic and allied drugs andcosmetics. 6
The salient features of the Drugs & Cosmetics Act, 1940 are as follows: a) Maximum penalty life imprisonment and fine of Rs. 10 lakhs or 3 times thevalue of the confiscated goods, whichever ismore. b) Some of the offences cognizable andnon-bailable. c)Besides officers from the Drug Controller s Office, other gazette officersalso authorized to launch prosecution under theAct; d) Specially designated courts for trial of offences covered under theAct; e) Provision for compounding of minoroffences. 7
Definitions Drugs : All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings oranimals. 8
Cosmetic : Any article intended to be rubbed, poured, sprinkled or sprayed on, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic. 9
Misbranded drugs : a) if it is so coloured, coated, powdered or polished that damage isconcealed b) if it is not labelled in the prescribed manner;or c) 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. 10
Adulterated drug : (a)if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or (b)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;or (c)if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious tohealth. 11
Spurious drugs : (a) if it is imported under a name which belongs to another drug;or (b)if it is an imitation of, or a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of anotherdrug.or (c) if it has been substituted wholly or in part by another drug orsubstance. 12
Manufacture : In relation to any drug or cosmetic, it includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution but does not include the compounding or dispensing of anydrug. 13
Patent or Proprietary medicine : A drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorized in this behalf by the CentralGovernment. 14
Administration of the act and rules A)Advisory : 1)Drugs Technical AdvisoryBoard-DTAB 2)Drugs ConsultativeCommittee-D.C.C. B)Analytical : 1)Central Drugs Laboratory - CDL 2)Drug Control Laboratory instates 3)Government Analysts C) Executives : 1)Licensing authorities 2)Controlling authorities 3)Drug Inspectors 15
Drugs Technical AdvisoryBoard(DTAB) Ex-Officio: (i) Director General of Health Services(Chairman) (ii) Drugs Controller, India (iii)Director of the Central Drugs Laboratory,Calcutta (iv)Director of the Central Research Institute, Kasauli (v)Director of Indian Veterinary Research Institute,Izatnagar (vi) President of Medical Council ofIndia (vii)President of the Pharmacy Council of India (viii)Director of Central Drug Research Institute,Lucknow 16
Nominated: 1) Two persons by the Central Government from among persons who are in charge of drugs control in theStates 2) One person by the Central Government from the pharmaceuticalindustry 3)Two persons holding the appointment of Government Analyst under this Act, to be nominated by the Central Government 17
Elected: 1)one person, to be elected by the Executive Committee of the Pharmacy Council of India, from among teachers in pharmacy or pharmaceutical chemistry or pharmacognosy on the staff of an Indian university or a collegeaffiliated. 2)one person, to be elected by the Executive Committee of the Medical Council of India, from among teachers in medicine or therapeutics on the staff of an Indian university or a college affiliated. 3)one pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research. 4)one person to be elected by the Central Council of the Indian Medical Association. 5)one person to be elected by the Council of the Indian Pharmaceutical Association. 18
Functions: To advise the Central Government and the State Governments on technical matters arising out of the administration of thisAct. To carry out the other functions assigned to it by thisAct. (The nominated and elected members of the Board shall hold office for three years, but shall be eligible for re-nomination andre-election) 19
Drugs Consultative Committee(DCC) It is also an advisory body constituted by centralgovernment. Constitution: Two representatives of the Central Government One representative of each StateGovernment 20
Functions: To advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any other matter tending to secure uniformity throughout India in the administration of thisAct. The Drugs Consultative Committee shall meet whenrequired Has power to regulate its own procedure. 21
Central Drug Laboratory(CDL) Established in Calcutta, under the control of a director appointed by the Central Government Functions: Analysis or test of samples of drugs/cosmetics sent by the custom collectors or courts. Analytical Q.C. of the importedsamples. Collection, storage and distribution of internalstandards. Preparation of reference standards and theirmaintenance. Maintenance of microbialcultures. Any other duties entrusted by CentralGovernment. Acting as an appellate authority in matter ofdisputes. 22
Import of Drugs Classes of drugs prohibited to import Import of drug underlicense 1)Specified in Schedule-X 2)Any new drugs Drugs exempted from provisions ofimport Offences and Penalties 23
Classes Of Drugs Prohibited ToImport Misbranded drugs Drugs of substandardquality Drugs claiming to cure diseases specified in Sch-J Adulterated drugs Spurious drugs Drugs whose manufacture, sale/distribution are prohibited in original country, except for the purpose of test, examination and analysis. Patent/Proprietary medicines whose true formula is notdisclosed. 24
Import of the biological drugs(C/C1) Conditions to be fulfilled: Licensee must have adequate facility for thestorage. Licensee must maintain a record of the sale, showing the particulars of the names of drugs and of the persons to whom they have beensold. Licensee must allow an inspector to inspect premises and to check therecords. Licensee must furnish the sample to theauthority. 25
Import of the Schedule-X drugs (Narcotic & Psychotropic drugs) Conditions to be fulfilled: Licensee must have,adequate storagefacility. Applicant must be reputable in the occupation, trade orbusiness. The license granted ever before should not be suspended orcancelled. 26
Drugs Imported for examination, test or analysis Conditions to be fulfilled: License is necessary under form-11 Must use imported drugs only for said purpose and at the place specified in the license. Must keep the record with respect to quantities, name of the manufacturer and date of import. Must allow an inspector to inspect the premises and check therecords. 27
Import of cosmetics Cosmetics prohibited to import: Misbranded cosmetics Spurious cosmetics Cosmetic containing harmfulingredients Cosmetics not of standard quality which contains more than-2 ppm Arsenic, 20 ppm lead, 100 ppm heavymetals 28
Penalties related to Import OFFENCES PENALTIES Import of spurious OR adulterated drug OR drug which involves risk to human beings or animals OR drug not having therapeutic values a) 3 years imprisonment and 5000 Rs. fine on first conviction b) 5 years imprisonment OR 1000 Rs. fine OR both for subsequentconviction Contravention of theprovision a) 6 months imprisonment OR 500 Rs. fine OR both for firstconviction b) 1 year imprisonment OR 1000 Rs. fine for subsequent offence 29
Prohibition of manufacture Drug not of standard quality or misbranded, adulterated orspurious. Patent or Proprietarymedicine. Drugs which claims to cure diseases specified inSch-J. Drugs which Risky to human beings oranimals. Drugs without therapeuticvalue. 30
Types of manufacturing license Allopathic Drugs Sch.- C/C1 But not -X Sch.-X Other than Sch.- C/C1& X Sch.-C/C1& X Drugs for the purpose of examinationtest oranalysis Own Premises Own Premises Loan License Own Premises Repacking license 31 31
Manuf. of drugs other than in Sch-C/C1 Conditions: Premises should comply with schedule M . Adequate facility for testing, separate frommanufacturing. Adequate storagefacility. Records of mfg. & testing-maintained for at least 2 years from date ofExp. License should provide sample toauthority. Furnish data of stability. Maintain the inspectionbook. Maintain reference samples from each batch. Accounts of production recorded & maintained for 5 years or 1 year after Expiry. 32
Manufacture Of Sch-X drugs Conditions: Have to sent invoice of sale to licensing authority every 3 months Store drugs in direct custody of responsible person. Preparation must be labeled with XRx Marketed in packing not exceeding 100 unit dose Tablets/Capsules 300 ml- Oral liquid 5 ml - Injection 33
Manuf. of drugs those in Schedule- C/C1(Biological) Conditions: Drugs must be issued in previously sterilized sealed glass or suitablecontainer Containers should comply with req. ofSch-F/F1 Drug must comply with std. (quality, purity, strength) specified insch.-F Parenteral in doses of 10 ml or more should be tested for freedom from Pyrogens Separate lab. for culture & manipulation of spore bearingPathogens Test for sterility should be carriedout. 34
Penalties related toManufacture OFFENCES PENALTIES Manufacture of any spuriousdrugs a) 1-3 years imprisonment and Rs.5000 fine b) 2-6 years imprisonment & Rs.10000 fine on subsequentconviction Manufacture of adulterateddrugs a) 1 year imprisonment & Rs.2000 fine b) 2 years imprisonment & Rs.2000 fine for subsequentconviction Manuf. of drugs in contravention of the provisions a) Imprisonment up to 3 months & Rs.500 fine b) Imprisonment up Rs.1000 fine on subsequentconviction to 6 months & 35
Loan License Definition: A person(applicant) who does not have his own arrangements(factory) for manufacture but who wish to avail the manufacturing facilities owned by another licensee. Such licenses are called Loan licenses. Procedure: Licence is obtained from licensing authority (FDA) on application in prescribed forms (24-A , 27-A) with prescribed fees (Rs. 6000,1500). 36
Repackaging license Definition: Process of breaking up any drug from a bulk container into small packages and labeling with a view to their sale and distribution. Repackaging of drugs is granted of drugs other than Schedule-C/C1 and X. Procedure: Licence is obtained from licensing authority (FDA) on application in prescribed forms (24-B) with prescribed fees (Rs. 500,200). 37
TYPES OF SALESLICENCES Allopathic Drugs Whole Sale Retail Sale Sales From MotorVehicle (Vender) Restricted Licence General Licence Drugsin Sch.- C/C1 Drugs in Sch.- X For Sch.- C/3 C 81 Drugs otherthan sch.-C/C1
Classes of drugs prohibited to be sold Misbranded, spurious, adulterated and drugs not of standardquality Patent/Proprietary drugs with undisclosedformula Sch-J drugs Expired drugs. 39
Wholesale Of Biological (C/C1) Adequate premises, with greater than 10 M2 area, with proper storagefacility Drugs sold only to retailer havinglicense Premises should be in charge of competent person who is Reg.Pharmacist. Records of purchase &sale Records preserved for 3 years from date ofsale License should displayed on premises 40
Wholesale Of Other ThanThose Specified In C/C1 And X All the conditions as discussed in forbiological. Compounding is made by or under the direct and personal supervision of a qualified person. 41
Retail sale For retail sale, two types of licenses are issued: i) General licenses ii) Restricted licenses Restricted license: Granted to those dealers who do not engage the services of a qualified person and only deal with such classes of drugs whose sales can be effected without qualified person and vendors who do not have fixedpremises. 42
Labeling & Packaging All the general and specific labeling and packaging specified to all classes of drugs and cosmetics should be as per the provisions made under theact. 43
Schedules to the rules TYPE CONTENT Performa for forms no. 1 to 50( Application, issue, renewal,etc.) A Rates of fee for test or analysis by CDL or Govt.analysts B List of Biological and special products (Injectable) applicable to special provisions. Ex. Sera, Vaccines,Penicillin ..etc List of Biological and special products (nonparenteral) applicable to special provisions. Ex. Digitalis, Hormones , Ergot List of drugs that are exempted from provisions ofimport C C1 D List of poisonous substances under the Ayurvedic , Siddha and Unani systems Provisions applicable to bloodbank E1 F 44
Schedules to the rules TYPE CONTENT Special provision applicable to biological and special products, e.g. Bacterial and viral vaccines, sera from living animals, bacterial origin diagnostic agents F1 Standards for surgicaldressings F2 Standards for umbilicaltapes F3 Standards for ophthalmicpreparations FF List of substances required to be used under medical supervision and labelled accordingly Ex. Metformin, Anti Histaminic, etc. G List of substances (prescription) that should be sold by retail only on prescriptions of R.M.P. Ex. Atenolol, Lorazepam, Dapson etc. H 45
Schedules to the rules CONTENT TYPE List of diseases and ailments that drug should not claim tocure Ex. Cancer, AIDS, Cataract,Diabetes etc List of drugs that are exempted from certain provisions regarding manufacture Requirements of manufacturing premises, GMP requirements offactory premises, plants and equipments Requirements of factory premises for manufacture ofHomeopathic medicines Requirements of factory premises for manufacture ofcosmetics J K M M1 M2 Requirements of factory premises for manufacture of medicaldevices M3 List of equipment to run a Pharmacy N Standards for disinfectant fluids Ex Phenol, H2O2,alcohol . O 46
Schedules to the rules TYPE CONTENT Life period(expiry) of drugs Ex. Insulin Inj. 24months P Coal tar colors permitted to be used in cosmetics Ex. Caramel,TiO2, Toney red .. Standards for mechanicalcontraceptives Q R Standards for medicaldevices R1 Standards forcosmetics S Requirements (GMP) of factory premises for Ayurvedic, Siddha, Unani drugs T Manufacturing and analytical records ofdrugs U 47
Schedules to therules TYPE CONTENT Manufacturing and analytical records ofcosmetics U1 Standards for patent or proprietarymedicines V List of drugs marketed under generic names-Omitted W List of narcotic drugs and psychotropicsubstances EX. Opium, Morphine, Barbital X Requirement and guidelines on clinical trials for import and manufacture of new drugs Y 48
