D _c_act

Drugs and Cosmetics Act
1940
and Rules 1945

Contents
 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
 Recent amendment act, 2008
2

Kiran Sharma, Assistant Professor

4/2/2012

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
3


4/2/2012

LIST OF AMENDING ACTS AND
ADAPTATION ORDERS
1. The Drugs (Amendment) Act, 1955
4. The Drugs and Cosmetics (Amendment)
Act, 1964
Act, 1972
Act, 1982
4/2/2012
4
Act, 1995

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.
 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 Kiran Sharma, Assistant Professor
establish Drugs Technical Advisory
4/2/2012
5
Board(DTAB)
and
Drugs
Consultative

THE DRUGS AND COSMETICS
ACT, 1940

6


4/2/2012

Definitions
Drugs :
All

medicines

external

use

of

for

internal

human

beings

or
or

animals and all substances intended
to

be

diagnosis,

used

for

treatment,

or

in

mitigation

the
or

prevention of any disease or disorder
7

in human beings or animals, including
4/2/2012

Definitions
Cosmetic :
Any

article

intended

to

be

rubbed, poured, sprinkled or sprayed

on, or introduced into, or otherwise
applied to, the human body or any
part
cleansing,
8

thereof
beautifying,


attractiveness,

or

for
promoting

altering

4/2/2012

the

Definitions
Misbranded drugs :
a)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 value than it really is; or
b) if it is not labelled in the prescribed

manner; or
c) if its label or container or anything
accompanying the drug bears any
Kiran Sharma, Assistant
4/2/2012
9 statement, Professor
design or device which makes

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
10

(c) if its container is composed in whole or
4/2/2012

(d) if it bears or contains, for purposes of
colouring only, a colour other than one
which is prescribed; or
(e) if it contains any harmful or toxic
substance which may render it injurious to
health; or
(f) if any substance has been mixed
e.g. supply of cheap cottonseed oil in
therewith so as to reduce its quality or
place of
strength.olive oil.
11


4/2/2012

Spurious drugs :
(a) if it is imported under a name which
belongs to another drug; or

12

(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
unless it is plainly and conspicuously
marked so as to reveal its true
4/2/2012
character and its lack of identity with

(c) if the label or the container bears
the name of an individual or company
purporting to be the manufacturer of the
drug, which individual or company is
fictitious or does not exist; or
(d) if it has been substituted wholly or in
part by another drug or substance;
e.g., when methamphetamine is sold as
(e) if it purports to be the product of a
cocaine
4/2/2012
13 manufacturer of whom it is not truly a

Manufacture :
In relation to any drug or
cosmetic, it includes any process or
part
of
a
process
for
making, altering, ornamenting, finish
ing, 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 Assistantthe
compounding
or
Kiran Sharma,
Professor
4/2/2012
14
dispensing of any drug, or the

Patent or Proprietary
medicine :

15

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
4/2/2012
or any other Pharmacopoeia

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


4/2/2012

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
4/2/2012
17
(vii) President of the Pharmacy Council of

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
18

Government Analyst under this Act, to
4/2/2012

Drugs Technical Advisory
Elected: Board(DTAB)
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 thereto;
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 thereto;
3)one Sharma, Assistant Professor
Kiran pharmacologist to be elected by the
19
4/2/2012
Governing Body of the Indian Council of

Functions:
To advise the Central Government and
the State Governments on technical
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
but shall be eligible for4/2/2012
reKiran Sharma, Assistant Professor
20 years,

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


4/2/2012

Drugs Consultative Committee(DCC)
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
22


4/2/2012

Schedules to the act
 1. Names of books under Ayurvedic, Siddha and

Unani Tibb systems
 2. Standard to be complied with by imported
drugs and by drugs manufactured for
sale, stocked or exhibited for sale, sold or
distributed.
 Appendix I, II, III, IV, V, VI.
23


4/2/2012

DRUGS AND COSMETICS
RULES, 1945

24


4/2/2012

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 imported samples.
 Collection, storage and distribution of
internal standards.
 Preparation of reference standards and
Kiran
4/2/2012
25 theirSharma, Assistant Professor
maintenance.

26


4/2/2012

IMPORT

27


4/2/2012

IMPORT of drugs & cosmetics
 Classes of drugs prohibited to import
 Import of drug under license

1)Specified in Schedule-C/C1
2)Specified in Schedule-X
3)Imported for Test/Analysis
4)Imported for personal use
5)Any new drugs
 Drugs exempted from provisions of import
 Offences and Penalties
28


4/2/2012

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
4/2/2012
29 analysis.

Classes of drugs prohibited to import
 Drugs

not
labelled/packed
prescribed manner.

in

 Drugs of biological poducts(C/C1) after

the date of expiry

 Drugs not claiming therapeutic values.
 Drugs which is risky to human beings or
30

animals.

4/2/2012

Import of the biological drugs(C/C1)

Conditions to be fulfillled:

 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.
31


 Licensee

4/2/2012

must furnish the sample to the

Import of the Schedule-X drugs
(Narcotic & Psychotropic drugs)
Conditions to be fulfilled:
 Licensee

must

have

adequate

storage

facility.
 Applicant

must be reputable
occupation, trade or business.

in

the

 The license granted ever before should not

be suspended or cancelled.
32


4/2/2012
The licensee has not been convicted any

Drugs Imported for examination, test or
analysis
 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.

33


Kiran
4/2/2012
MustSharma, Assistant Professorinspector to inspect the
allow an

Drugs imported for personal use
 Up to 100 average doses may be imported

without any permit, provided it is part of
passenger‟s luggage.
 More than 100 doses imported with license.

Apply on form no.-12-A,12-B
 Drugs must be bonafide personal use.

34

Drugs must Professor declared to the custom
be
4/2/2012

Import of drugs without license
 Substances not used for medicinal pupose
 Drugs

in
Sch-C1
required
for
manufacturing and not for medicinal use.
 Substances which are both drugs and
foods such as:
Condensed/Powdered Milk
Malt
Lactose
Farex/Cereal
Oats
4/2/2012
35 Predigested foods

Penalties related to Import

OFFENCES

36

PENALTIES

Import of spurious OR a)3
years
adulterated drug OR
imprisonment and
drug which involves
5000 Rs.
fine on
risk to human beings
first conviction
or animals OR drug b)5
years
not
having
imprisonment
OR
therapeutic values
1000 Rs. fine OR
both
for
subsequent
conviction
Contravention
of a)6
months
4/2/2012
the provision
imprisonment
OR

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
37

ppm lead, 100 ppm heavy metals

4/2/2012

Cont….
 Cosmetics meant for eye and containing

coal tar dyes
 Cosmetics coloured with lead OR arsenic

compounds
 Cosmetics containing Hexachlorophene

OR Mercury

38

Risky to user

4/2/2012

Chapter iv
MANUFACTURE, sale &
distribution of drugs and
cosmetics
39


4/2/2012

Manufacture
 Prohibition of manufacture

 Manufacture of other than in Sch-C/C1
 Manufacture of those in Sch-C/C1
 Manufacture of Sch-X drugs

 Loan license
 Repackaging license
 Offences & Penalties

40


4/2/2012

 Drug

Prohibition of manufacture

not of standard quality
misbranded, adulterated or spurious.

or

 Patent or Proprietary medicine

 Drugs

which claims
specified in Sch-J

to

cure

diseases

 Drugs which Risky to human beings or

animals
41


 Drugs without therapeutic value

4/2/2012

Types of manufacturing licences
Allopathic Drugs

Other
than Sch.C/C1 & X

Sch.C/C1 But
not -X

Sch.-X

Own
Premise
s
Own Premises

Sch.-C/C1
&X

Own
Premise
s

Drugs for
the
purpose of
examinati
on test or
analysis

Loan
Licence

Repacki
ng
licence Sharma, Assistant Professor
Kiran
4/2/2012

42

Manuf. of drugs other than in Sch-C/C1
Conditions:

 Premises should comply with schedule „m‟

 Adequate facility for testing, separate






43


from manufacturing
Adequate storage facility
Records of mfg. & testing-maintained for
at least 2 years from date of Exp.
Licence
should
provide
sample
to
authority
Furnish data of stability
Maintain the inspection book
Maintain reference samples from 4/2/2012
each

44


4/2/2012

Manuf. of drugs those in ScheduleC/C1(Biological)

Conditions:
 Drugs





45



must be issued in previously
sterilized sealed glass or suitable
container
Containers should comply with req. of SchF/F1
Drug
must
comply
with
std.
(quality, purity, strength) specified in sch.F
Serum tested for freedom from abnormal
toxicity
4/2/2012
Parenteral in doses of 10 ml or more

Manufacture Of Sch-X drugs
Conditions:
 Accounts of all transactions regarding






46

manuf. should be maintained in serially
bound & paged register.(Preserved for 5
years)
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 inProfessor
packings not exceeding
4/2/2012
 100 unit dose –Tablets/Capsules

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.
47

6000,Sharma, Assistant Professor
1500).
Kiran

4/2/2012

FORM 27-A
(See Rule 75-A)
Application for grant or renewal of a loan license to manufacture for sale 8a(or for distribution of) drugs
specified in Schedules C and C(1)8b(excluding those specified in 8c(Part XB and) Sch. X)
1.I/We *………………………….. of……………………….hereby apply for the grant/renewal of loan
license to manufacture on the premises situated at…………C/o………… the under mentioned drugs, being
drugs specified in Schedules C and C(1) 8b(excluding those specified in 8c(Part XB and) Sch .X) to the
Drugs and Cosmetics Rules, 1945.
Names of drugs (each substance to be separately specified).
1.

The names, qualifications and experience of the expert staff actually connected with the manufacture and
testing of the specified products in the manufacturing premises.
a)Name(s) of expert staff responsible for manufacture……………..
b)Name(s) of expert staff responsible for testing……………

1.

I/We enclose:a)A true copy of a letter from me/us to the manufacturing concern whose manufacturing capacity is
intended to be utilized by me/us.
b) A true copy of a letter from the manufacturing concern that they agree to lend the services of their

48


4/2/2012

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:
49


Licence

is

obtained

from

4/2/2012

licensing

Penalties related to Manufacture

50

OFFENCES
PENALTIES
Manufacture of any a)1-3
years
spurious drugs
imprisonment
and
Rs.5000 fine
b)2-6
years
imprisonment
&
Rs.10000
fine
on
subsequent
conviction
Manufacture
of a)1 year imprisonment
adulterated drugs
& Rs.2000 fine
b)2
years
imprisonment
&
Rs.2000
fine 4/2/2012
for

Manufacture of cosmetics
Prohibited for the following classes of
drug:
 Misbranded or spurious cosmetics and of
substandard quality
 Cosmetics containing hexachlorophene or
mercury compounds
 Cosmetics containing color which contain
more than- 2 ppm of arsenic
- 20 ppm of lead
4/2/2012
51
- 100 ppm of heavy metals

SALE

52


4/2/2012

Sale of Drugs
 Classes of drugs prohibited to be sold
 Wholesale of biological (C/C1)
 Wholesale of other than those specified

in C/C1 and X
 Wholesale of Sch-X drugs

 Retail sale
53


4/2/2012

TYPES OF SALES LICENCES
Allopathic Drugs

Whole Sale

Retail Sale

General Licence

Drugs in
Sch.- X
54

Drugs in
Sch.Kiran Sharma, Assistant Professor
C/C1

Sales From
Motor Vehicle
( Vender)

Restricted
Licence

Drugs
other than
sch.-C/C1

For
Sch.4/2/2012
C/C1

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.

 Drugs used for consumption by government
55

Kiran Sharma, such as
schemes Assistant ProfessorE.S.I.S., Armed force.

4/2/2012

Forms
Fees for
Renewal
Fee+ Penalty after
Fees for
duplicate
Certificate Form expiry but within six
Grant/Renewal
copy of Org.
No.
months
Lic.
Rs.1500+Rs.500 p.m.
Rs.1500
21 -C
Rs.150
or part there of
Rs.1500+Rs.500 p.m.
Rs.1500
21 -C
Rs.150
or part there of

4

5

56

20-B

Retail Sale

19

20

19-A

20-A R-61 (1)

Rs.500 R-59 (2)

21 -C

19

21B

Rs.1500

21 -C

19

21

Rs.1500

21 -C

19-A

21-A R-61 (1)

Rs.500 R-59 (2)

21 -C

Rs.500+Rs.250 p.m. or Rs.150 R- 59
part thereof R-59 (4)
(3)

19-C

20-G

Rs.500

21-C

Rs.500+Rs.250 p.m. or
part there of

Retail Sale

19-C

20-F R-61(1)

Rs.500 R-59(2)

21-C

Rs.500+Rs.250 p.m. or Rs.150 R- 59
part there of R-59(4)
(3)

Whole Sale

19-AA

20-BB

Rs.500

21-CC

Whole Sale

19-AA

21-BB R-62-D

Rs.500

21-CC

Whole Sale

3

19

Whole Sale

2

Drugs other than
those specified in
Schedule C&C (1)&X

Licence Form

Restricted(Gen.Store)

1

Category

Type Sale

Whole Sale

S.No.

Application
Form

19-B

20-D

Rs.250

20-E

Whole Sale
Drugs specified in
Schedule C&C (1)
Retail Sale
but excluding those
specified in Schedule
‘X’
Restricted(Gen.Store)

Drugs specified in
Schedule ‘X’
Sale of Drugs from
motor vehicles (1)
Drugs other than
those specified in
Schedule C&C (1)
(2) Drugs specified in
Schedule C&C (1)

Homoeopathic
Medicines Sharma, Assistant
Kiran
Retail Sale

Professor
19-B

20-C
R-67-C

Rs. 250
R-67-A(2)

20-E

Rs.500+Rs.250 p.m. or Rs.150 R- 59
part thereof R-59 (4)
(3)
Rs.1500+Rs.500 p.m.
or part there of
Rs.1500+Rs.500 p.m.
or part there of

Rs.500+Rs.250 p.m. or
part there of

Rs.500+Rs.250 p.m. or
part there of
Rs.250+Rs.50p.m. or
part there of

Rs.150
Rs.150

Rs.150

Rs.150

Rs.150
Rs. 50

Rs. 50
R-67-A(2)
Rs.250+Rs.50p.m. or
4/2/2012 No. 421
*GSR
part there of R-67-A(2)
dated
24/08/2001

FORM 19-C
{See Rule 59(2)}
Application for grant or renewal of a {licence to sell, stock, exhibit or offer for sale, or
distribute} drugs specified in Schedule X
1. I/We ……………………….. of …………..hereby apply for a licence to sell by
Wholesale/retail drugs specified in Schedule-X to the Drugs and Cosmetics
Rules, 1945. We operate a pharmacy on the premises, situated at………….
2. The sale and dispensing of drugs will be made under the personal supervision of the
qualified persons mentioned below:Name………………….(Qualification)
Name………………….(Qualification)
1. Name of drugs to be sold .
2. Particulars of storage accommodation.
3. A fee of rupees…………………….. has been credited to Government account under
the head of account………………………………….
Date………………………….
Signature……………………

57


4/2/2012

Wholesale of biological (C/C1)
 Adequate premises, with greater than 10

M2 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
58


of sale

4/2/2012

Wholesale of other than those
specified in C/C1 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.

59


4/2/2012

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
60

and Sharma, Assistant Professor
Kiran only deal with such classes of drugs
4/2/2012

FORM 19-A
{(See Rule 59(2)}
Application for the grant or renewal of a restricted licence to sell, stock or exhibit {or offer}
for sale or distribute drugs by retail by dealers Who do not engage the service of a qualified
person.
1.I/We …………………………….. of
………………………..hereby apply for a licence to sell by retail (i){Drugs other than
those specified in Schedule C, C(1) and X on the premises situated at
……………………….or (ii) Drugs specified in {Schedule C(1) on the premises
situated drugs specified in {Schedule C(1) as vendor in the at……………………..
are………………………………..
2. Sales shall be restricted to such drugs as can be sold without the supervision of a
qualified person under the Drugs and Cosmetics Rules.
3. Names or classes of drugs proposed to be sold…………………………………..
4. Particulars of the storage accommodation for the storage of {Schedule C(1) drugs on the
premises referred to above.
5. The drugs for sale will be purchased from the following dealers and such other dealers as
may be endorsed on the licence by the licensing authority from time to time.
6. A fee of rupees __________ has been credited to Government under the head of account
………………………
Date……………………..
Signature……………………….

61


4/2/2012

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.

62


4/2/2012

Schedules to the act
 First schedule – Names of books

under Ayurvedic and Siddha systems
 Second schedule – Standard to be

complied with by imported drugs and
by

drugs

manufactured

for

sale, sold, stocked or exhibited for
63

sale or distribution

4/2/2012

Schedules to the rules
TYPE

“a”

CONTENT

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
“c1”
List of Biological and special products
(nonparenteral)
applicable
to
special
provisions.
Ex. Digitalis, Hormones , Ergot
drugs that are exempted from
Sharma, of
4/2/2012
64“d” Kiran List Assistant Professor
provisions of import

TYPE

CONTENT

“f1”

“f2”

Special
provision
applicable
to
biological and special products, eg.
Bacterial and viral vaccines, sera from
living
animals,
bacterial
origin
diagnostic agents
Standards for surgical dressings

“f3”

Standards for umbilical tapes

“ff”

Standards for ophthalmic preparations

“g”
65

List of substances required to be used
Kiran under medical supervision and labelled
Sharma, Assistant Professor
4/2/2012

TYPE

CONTENT

“j”

List of diseases and ailments that drug should
not claim to cure
Ex. Cancer, AIDS, Cataract, Diabetes…etc
List of drugs that are exempted from certain
provisions regarding manufacture

“k”
“m”

Requirements of manufacturing premises, GMP
requirements of factory premises, plants and
equipments

“m1”

Requirements of factory premises for
manufacture of Homeopathic medicines
“m2” Requirements of factory premises for
manufacture of cosmetics
“m
Requirements of
66 3” Kiran Sharma, Assistant Professor factory premises for
manufacture of medical devices

4/2/2012

TYPE
“p”

CONTENT

“r”

Life period(expiry) of drugs Ex. Insuline Inj. –
24 months
Coal tar colors permitted to be used in
cosmetics ex. caramel, tio2, toney red…..
Standards for mechanical contraceptives

“r1”

Standards for medical devices

“s”

Standards for cosmetics

“t”

Requirements (GMP) of factory premises for
Ayurvedic, Siddha, Unani drugs

“q”

67“u” Kiran Sharma, Assistant Professor
Manufacturing

4/2/2012
and analytical records of

TYPE

CONTENT

“u1”

Manufacturing and analytical records of
cosmetics

“v”

Standards for patent or proprietary
medicines

“w”

List of drugs marketed under generic
names- Omitted

“x”

68

List of narcotic drugs and psychotropic
substances
EX. Opium, Morphine, Barbital……
“y”
Requirement and guidelines on clinical
trials Professor
Kiran Sharma, Assistant for import and manufacture of new
4/2/2012
drugs

Drugs and Cosmetics (Amendment)
Act, 2008
Salient features of the Act: Substantial enhancement in punishment
 Life imprisonment for offenders involved

in manufacture, sale and distribution of
spurious and adulterated drug likely to
cause grievous hurt
 Minimum punishment of seven years which
69

may extendProfessor
to life imprisonment

4/2/2012

Drugs and Cosmetics
(Amendment) Act, 2008
Salient features of the Act: Corresponding enhancement in punishment

for repeated offenders
 Cognizance can be taken on the complaint

of any gazetted officer authorized by
Central or State Government
70


4/2/2012

Drugs and Cosmetics
(Amendment) Act, 2008
Salient features of the Act: Designation of special courts for trial of

offences in respect of adulterated and
spurious drugs

 All offences relating to adulterated and

spurious drugs made cognizable and non
bailable

 Restrictions on bail – Bail cannot be

granted unless public prosecutor is heard

71


 Certain offences made compoundable

4/2/2012

SCHEDULE M

72


4/2/2012

SCHEDULE M
GOOD MANUFACTURING PRACTICES
AND REQUIREMENTS OF
PREMISES, PLANT AND EQUIPMENT
FOR PHARMACEUTICAL PRODUCTS.
1. GENERAL REQUIREMENTS
Location and surroundings
Building and premises
Water System
Disposal of waste
2. WAREHOUSING AREA
3. PRODUCTION AREA
4. ANCILLARY AREAS





73


4/2/2012

74

 5. Quality Control Area
 6. Personnel
 7. Health, clothing and sanitation of workers
 8. Manufacturing Operations and Controls
 9. Sanitation in the Manufacturing Premises
 10. Raw Materials
 11. Equipment
 12. Documentation and Records
 13. Labels and other Printed Materials
 14. Quality Assurance
 15. Self Inspection and Quality audit
 16. Quality Control System
 17. Specification
 18. Master Formula Records
 19. packaging records
 20. batch packaging records
 21. batch processing records
 22. SOPs and Records

4/2/2012

Schedule y

75


4/2/2012

Schedule y
REQUIREMENTS AND GUIDELINES FOR PERMISSION
TO IMPORT AND / OR MANUFACTURE OF NEW
DRUGS FOR SALE OR TO UNDERTAKE CLINICAL
TRIALS
Schedule Y for India is a law and not a mere guideline. The
enforcement that came into existence in 1988 was an
essential provision for providing support to the upscale of
generic pharma scenic present in those days.
1. Application for permission
2. CLINICAL TRIAL
3. Studies in special populations
4. Post Marketing Surveillance
4/2/2012
76
5. Special studies: Bioavailability / Bioequivalence

 APPENDIX I - DATA TO BE SUBMITTED ALONG WITH








77

THE APPLICATION TO CONDUCT CLINICAL TRIALS /
IMPORT / MANUFACTURE OF NEW DRUGS FOR
MARKETING IN THE COUNTRY.
APPENDIX I-A - DATA REQUIRED TO BE SUBMITTED
BY AN APPLICANT FOR GRANT OF PERMISSION TO
IMPORT AND / OR MANUFACTURE A NEW DRUG
ALREADY APPROVED IN THE COUNTRY.
Appendix II - STRUCTURE, CONTENTS AND FORMAT
FOR CLINICAL STUDY REPORTS
Appendix III - ANIMAL TOXICOLOGY (NON-CLINICAL
TOXICITY STUDIES)
Appendix IV - ANIMAL PHARMACOLOGY
APPENDIX V – INFORMED CONSENT
APPENDIX VII – UNDERTAKING BY THE
INVESTIGATOR
APPENDIX VIII – ETHICS COMMITTEE
APPENDIX X – CONTENTS OF PROTOCOL
APPENDIX XI – DATA ELEMENTS FOR REPORTING
SAE


4/2/2012

78

1. Application for permission.- Application for
permission to import or manufacture new drugs for
sale or to undertake clinical trials shall be made in
Form 44 accompanied with following data in
accordance with the appendices, namely: Chemical and pharmaceutical information
 Animal toxicology data
 Human Clinical Pharmacology Data
 For new drug substances discovered in India, clinical
trials are required to be carried out in India right from
Phase I
 For new drug substances discovered in countries
other than India, Phase I data as required should be
submitted along with the application. After
submission of Phase I data generated outside India
to the Licensing Authority, permission may be granted
to repeat Phase I trials and/or to conduct Phase II
trials and subsequently Phase III trials concurrently
with other global trials for that drug.
4/2/2012
 Regulatory status in other countries

2. CLINICAL TRIAL
 (1)







79

Approval for clinical trial
Clinical trial on a new drug shall be initiated only
after the permission has been granted by the
Licensing Authority under rule 21 (b), and the
approval obtained from the respective ethics
committee(s).
(2) Responsibilities of Sponsor
(3) Responsibilities of the Investigator(s)
(4) Informed Consent
(5) Responsibilities of the Ethics Committee


4/2/2012

 (6) Human Pharmacology (Phase I)
 The objective of studies in this Phase is the

80

estimation of safety and tolerability with the initial
administration of an investigational new drug into
human(s). Studies in this Phase of development
usually have non-therapeutic objectives and may be
conducted in healthy volunteers subjects or certain
types of patients.
 (7) Therapeutic exploratory trials (Phase II)
 The primary objective of Phase II trials is to evaluate
the effectiveness of a drug for a particular indication
or indications in patients with the condition under
study and to determine the common short-term sideeffects and risks associated with the drug. Studies in
Phase II should be conducted in a group of patients
4/2/2012
who are selected by relatively narrow criteria leading

 (8) Therapeutic confirmatory trials (Phase III)
 Phase III studies have primary objective of

81

demonstration or confirmation of therapeutic
benefit(s). Studies in Phase III are designed to
confirm the preliminary evidence accumulated in
Phase II that a drug is safe and effective for use
in the intended indication and recipient
population. These studies should be intended to
provide an adequate basis for marketing
approval. Studies in Phase III may also further
explore the dose-response relationships
(relationships among dose, drug concentration in
blood and clinical response), use of the drug in
wider populations, in different stages of
disease, or the safety and efficacy of the drug in
Kiran Sharma, Assistant Professor other drug(s).
4/2/2012
combination with

3. Studies in special
populations
 Information supporting the use of the drug in children, pregnant









82

women, nursing women, elderly patients, patients with renal or
other organ systems failure, and those on specific concomitant
medication is required to be submitted if relevant to the clinical
profile of the drug and its anticipated usage pattern.
(1) Geriatrics.-Geriatric patients should be included in Phase III
clinical trials (and in Phase II trials, at the Sponsor's option) in
meaningful numbers, if(a) the disease intended to be treated is characteristically a
disease of aging; or
(b) the population to be treated is known to include substantial
numbers of geriatric patients; or
(c) when there is specific reason to expect that conditions
common in the elderly are likely to be encountered; or
(d) when the new drug is likely to alter the geriatric patient's
response (with regard to safety or efficacy) compared with that of
the non-geriatric patient.


4/2/2012

 2) Pediatrics. (i) The timing of pediatric studies in the new drug

83

development program will depend on the medicinal
product, the type of disease being treated, safety
considerations, and the efficacy and safety of
available treatments. For a drug expected to be used
in children, evaluations should be made in the
appropriate age group. When clinical development is
to include studies in children, it is usually appropriate
to begin with older children before extending the trial
to younger children and then infants.
 3) Pregnant or nursing women. (i) Pregnant or nursing women should be included in
clinical trials only when the drug is intended for use by
pregnant/nursing women or fetuses/nursing infants
and where the data generated from women who are
not pregnant or nursing, is not suitable.
4/2/2012

Post Marketing Surveillance. Subsequent to approval of the product, new drugs







84

should be closely monitored for their clinical safety
once they are marketed. The applicants shall furnish
Periodic Safety Update Reports (PSURs) in order to(a) report all the relevant new information from
appropriate sources;
(b)
relate these data to patient exposure ;
(c) summarize the market authorization status in
different countries and any significant variations
related to safety; and
(d) indicate whether changes should be made to
product information in
order to optimize the use of the product.


4/2/2012

Special studies: Bioavailability /
Bioequivalence Studies
 (i) For drugs approved elsewhere in the world and

absorbed systemically, bioequivalence with the reference
formulation should be carried out wherever applicable.
These studies should be conducted under the labeled
conditions of administration. Data on the extent of systemic
absorption may be required for formulations other than
those designed for systemic absorption.

 (ii) Evaluation of the effect of food on absorption following

oral administration should be carried out. Data from
dissolution studies should also be submitted for all solid
oral dosage forms.

 (iii) Dissolution and bioavailability data submitted with the

85

new drug application must provide information that assures
bioequivalence or establishes bioavailability and dosage
correlations between the formulation(s) sought to be
4/2/2012
marketed and those used

THANKS

86


4/2/2012

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