Drug and Cosmetic Act

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 Contents
•Objectives

•Definitions

•Administration of the act and rules

•Provisions related to Import

•Provisions related to Manufacture

•Provisions related to Sale

•Schedules to the act and rules

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 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 establish Drugs Technical Advisory Board (DTAB) and
Drugs Consultative Committees (DCC) for Allopathic and
allied drugs and cosmetics.
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 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, including preparations applied on human
body for the purpose of repelling insects like
mosquitoes.

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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
thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance, and
includes any article intended for use as a component
of cosmetic.

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Misbranded drugs :
a) if it is so colored, 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 statement, design or device which makes any
false claim for the drug or which is false or misleading in
any particular.
Ex.
Xental 400, Pentoxiphylline
,Targof Pure Drug Ltd.
Zentel 400, Albendazole, Glaxo 6
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; or
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(d) if it bears or contains, for purposes of coloring only, a
color 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 therewith so as to

reduce its quality or strength.

e.g. supply of cheap cottonseed oil in place of

olive oil.
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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 unless it is plainly and conspicuously
marked so as to reveal its true character and its lack of
identity with such other drug; or

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 (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) if it purports to be the product of a manufacturer of whom

it is not truly a product.
e.g., when methamphetamine is sold as
cocaine
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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.

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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

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 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

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 Drugs Technical Advisory Board
(DTAB)
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

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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 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 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;

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 Drugs Technical Advisory
Board(DTAB)
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 years, but shall be eligible for re-nomination
and re-election)

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 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

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 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

▪Has power to regulate its own procedure.

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 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 their maintenance.
•Maintenance of microbial cultures.
•Any other duties entrusted by Central Government.
•Acting as an appellate authority in matter of disputes.
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 Manufacturing

Provisions of Act Sales

Labeling & Packaging

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 IMPORT of drugs
•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

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 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.

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 Classes of drugs prohibited to
import
•Drugs not labelled/packed in prescribed manner.

•Drugs of biological products (C/C1) after the date of expiry

•Drugs not claiming therapeutic values.

•Drugs which are risky to human beings or animals.

•Any new drug except with express permission of

Lic.authority.

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 Import of the biological drugs
(C/C1)
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.
•Licensee must not sell drugs from which sample is withdrawn
and he is advised not to sale, and recall the batch from the
market.
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 Import of the Schedule-X drugs
(Narcotic & Psychotropic drugs)
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.

•The licensee has not been convicted any offence under the
Drugs and Cosmetics Act or Narcotic and Psychotropic
Substances Act.

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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.
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 Drugs imported for personal use
Conditions to be fulfilled:
•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.

•Drugs must be declared to the custom collectors if so

directed.

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Import of drugs without license
•Substances not used for medicinal purpose
•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
•Predigested foods
•Ginger, Pepper, Cumin, Cinnamon

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 Penalties related to Import
OFFENCES PENALTIES

Import of spurious OR a) 3 years imprisonment

adulterated drug OR drug and 5000 Rs. fine on first
which involves risk to conviction
human beings or animals b) 5 years imprisonment OR
OR drug not having 1000 Rs. fine OR both for
therapeutic values subsequent conviction

Contravention of the a) 6 months imprisonment

provision OR 500 Rs. fine OR both
for first conviction
b) 1 year imprisonment OR
1000 Rs. fine for
subsequent offence
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 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

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 Cont….

•Cosmetics meant for eye and containing coal tar dyes

•Cosmetics colored with lead OR arsenic compounds

•Cosmetics containing Hexachlorophene OR Mercury

•Risky to user

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 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

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 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

•Preparation containing cyclamates

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 Types of manufacturing licences

Allopathic Drugs

Other than Sch.- Sch.-X Sch.-C/C1 & Drugs for the

Sch.- C/C1 & C/C1 But X purpose of
X not -X examination
test or
Own Own analysis
Premises Premises

Own Loan
Premises Licence
Repackin
g licence

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

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 Manuf. of drugs those in
Schedule-C/C1(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
•Serum tested for freedom from abnormal toxicity
•Parenteral in doses of 10 ml or more should be tested for
freedom from Pyrogens
•Separate lab. for culture & manipulation of spore bearing
Pathogens
•Test for sterility should be carried out.

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 Manufacture Of Sch-X drugs
Conditions:
•Accounts of all transactions regarding 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 in packings not exceeding
• 100 unit dose –Tablets/Capsules
• 300 ml- Oral liquid
• 5 ml - Injection

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 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:

License is obtained from licensing authority (FDA) on

application in prescribed forms (24-A , 27-A) with prescribed
fees (Rs. 6000, 1500).

Loan licenses are issued for:

1) Drugs other than specified in C/C1 & X.
2) Drugs specified in Schedule-C/C1
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 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

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 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). 40
 Penalties related to Manufacture
OFFENCES PENALTIES
Manufacture of any spurious drugs a) 1-3 years imprisonment and
Rs.5000 fine
b) 2-6 years imprisonment &
Rs.10000 fine on subsequent
conviction
Manufacture of adulterated drugs a) 1 year imprisonment & Rs.2000
fine
b) 2 years imprisonment &
Rs.2000 fine for subsequent
conviction
Manuf. of drugs in contravention of a) Imprisonment up to 3 months &
the provisions Rs.500 fine
b) Imprisonment up to 6 months &
Rs.1000 fine on subsequent
conviction
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 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
- 100 ppm of heavy metals
•Eye preparations containing coal-tar color

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 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

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 TYPES OF SALES
LICENCES
Allopathic Drugs

Whole Sale Retail Sale Sales From

Motor Vehicle (
Vender)

General Licence Restricted

Licence

Drugs in Drugs in Drugs other For

Sch.- X Sch.- C/C1 than Sch.- C/C1
sch.-C/C1 & 44
 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 schemes
such as E.S.I.S., Armed force.
•Physician’s samples

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 Forms
Fees for
Renewal Fee+ Penalty after
Application Fees for duplicate
S.No. Category Type Sale Licence Form Certificate Form expiry but within six
Form Grant/Renewal copy of Org.
No. months
Lic.
Rs.1500+Rs.500 p.m.
Whole Sale 19 20-B Rs.1500 21 -C Rs.150
or part there of
Drugs other than Rs.1500+Rs.500 p.m.
1 those specified in Retail Sale 19 20 Rs.1500 21 -C Rs.150
or part there of
Schedule C&C (1)&X
Rs.500+Rs.250 p.m. or Rs.150 R- 59
Restricted(Gen.Store) 19-A 20-A R-61 (1) Rs.500 R-59 (2) 21 -C
part thereof R-59 (4) (3)
Rs.1500+Rs.500 p.m.
Drugs specified in Whole Sale 19 21B Rs.1500 21 -C Rs.150
or part there of
Schedule C&C (1) Rs.1500+Rs.500 p.m.
2 but excluding those Retail Sale 19 21 Rs.1500 21 -C Rs.150
or part there of
specified in Schedule
Rs.500+Rs.250 p.m. or Rs.150 R- 59
‘X’ Restricted(Gen.Store) 19-A 21-A R-61 (1) Rs.500 R-59 (2) 21 -C
part thereof R-59 (4) (3)
Rs.500+Rs.250 p.m. or
Whole Sale 19-C 20-G Rs.500 21-C Rs.150
Drugs specified in part there of
3
Schedule ‘X’ Rs.500+Rs.250 p.m. or Rs.150 R- 59
Retail Sale 19-C 20-F R-61(1) Rs.500 R-59(2) 21-C
part there of R-59(4) (3)
Sale of Drugs from
motor vehicles (1)
Rs.500+Rs.250 p.m. or
Drugs other than Whole Sale 19-AA 20-BB Rs.500 21-CC Rs.150
part there of
4 those specified in
Schedule C&C (1)
(2) Drugs specified in Rs.500+Rs.250 p.m. or
Whole Sale 19-AA 21-BB R-62-D Rs.500 21-CC Rs.150
Schedule C&C (1) part there of
Rs.250+Rs.50p.m. or
Whole Sale 19-B 20-D Rs.250 20-E Rs. 50
part there of
Rs. 50
Homoeopathic
5 R-67-A(2)
Medicines 20-C Rs. 250 Rs.250+Rs.50p.m. or
Retail Sale 19-B 20-E *GSR No. 421
R-67-C R-67-A(2) part there of R-67-A(2)
dated
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24/08/2001
 Schedules to the rules
TYPE CONTENT

“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
“C1” List of Biological and special products (nonparenteral)
applicable to special provisions.
Ex. Digitalis, Hormones , Ergot
“D” List of drugs that are exempted from provisions of
import
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 Schedules to the rules
TYPE CONTENT
“F1” Special provision applicable to biological and
special products, eg. Bacterial and viral vaccines,
sera from living animals, bacterial origin
diagnostic agents
“F2” Standards for surgical dressings
“F3” 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 48
 Schedules to the rules
TYPE CONTENT
“J” List of diseases and ailments that drug should not
claim to cure
Ex. Cancer, AIDS, Cataract, Diabetes…etc
“K” List of drugs that are exempted from certain provisions
regarding manufacture
“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
“M3” Requirements of factory premises for manufacture of
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medical devices
 Schedules to the rules
TYPE CONTENT
“P” Life period(expiry) of drugs Ex. Insuline Inj. – 24
months
“Q” Coal tar colors permitted to be used in cosmetics Ex.
Caramel, TiO2, Toney red…..
“R” Standards for mechanical contraceptives

“R1” 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 50
 Schedules to the rules
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” 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
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