4

Cosmetics Act and Rules

Drugs and
classified
individual. They have been
health of an The Drugs
Drugs are vital to the under the Essential Commodities Act. with the
commodity" have been passed
as "essential Rules. 1945
and Cosmetics Act,
1940 and
manufacture, distribution and sale of
import,
objective of regulating the requlates the manufacture and Sale of drugs
Act manufactured, distrib
arugs and cosmetics. The licensing sóthat these are
and cosmetics through qualified persons. The Act covers the drugs under
by
uted and sold only homoeopathic and Unani Tibb systems as well às
allopathic, ayurvedic, main
prevent
object of the Act is to whole of
arugs for veterinary use., The extends to
SUbstandards in drugs. 1It is alife saving statute and
India.
Definitions
"Drugs" includes (a) all medicines for internal or external use of human
to be used for or in the
beings or animals and all substances intended any disease or disor
diagnosis, treatment, mitigation or prevention of
preparations applied on
der in human beings or animals, including insects like mosquitoes;
human body for the purpose of repelling ucture
(b) such substances (other than food) intended to affect the for the
or any function of the human body or intended to be used
destruction of the vermin or insects which cause disease in human
beings or animals, as may be specified from time to time by the Central
Government by notification in the Official Gazette; (c) all substances
intended for use as components of a drug including empty gelatin
capsules; and (d) such devices intended for internal or external use in
the diagnosis, treatment, mitigation or prevention of disease or disor
der in human beings or animals as specified by the Central Government.
"Cosmetic" means 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.

28
 29
DRUGS AND COSMETICS ACT AND RULES
Ch-4
means
Mpatent or propnetary medicine"
a) In relation to Ayurvedic, Sidha or Unani Tibb systems of medicine
armulations containing only such ingredients mentioned in the formu
Tibb
a Hescribed in the authoritative books of Ayurvedic, Sidha, Unani or
systemsof medicine specified in the First Schedule, but does not include a
Syicine which is administered by parenteral route and also a formulation
udedin the authoritative books as specified in the First Schedute;
(b) In relation to any other systems of medicine, a drug which is a
external
remedy or prescnption presented in a form ready for internal or
administration of human beings or animats and which is not included in
the edition of the Indian Pharmacopeia for the time being or any other
Pharmacopeia authorised in this behalf by the Central Government after
consultation with the DTAB.
"Misbranded drugs" A drug is deemed to be misbranded:
1. 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
2. if it is not labelled in the prescribed manner; or
3. 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" A drug is deemded to be adulterated:-
1. if it consists, in whole or part, of any filthy, putrid or decomposed
substance; or
2. if it has been prepared, packed or stored under insanitary condi
tions whereby it may have been rendered injurious to health; or
3. 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
4. if it bears or contains for purposes of colouring only, a colour
other than one which is prescribed; or
5. if it contains any harmful or toxic substance which may render it
injurious to health; or
6. if any substance has been mixed therewith so as to reduce its
quality or strength.
"Spurious drugs" Adrug is deemed to be spurious:
1. if it is imported (manufactured-in relation to manufacture, sale
and distribution of drugs) under a name which belongs to another
drug; or
 PHARMACEUTICAL JURISPRUDENCE
30
another drug or
2. if it is an imitation of or is a substitute for
or bears upon
resembles another drug in a manner likely to deceive drug unless it
it or upon its label or container the name of another
is plainly and conspicuously marked so as to reveal ts true
character and its lack of identity with such other drugs; or
3. if the label or container bears the name of an individual or
company purporting to be the manufacture of the drug, which
individual or company is fictitious or does not exist; or
4. if it has been substituted wholly or in part by another drug or
substance; or
5. if it purports to be the product of a manufacturer of whom it is
not truly a product.
"Misbranded cosmetics" Acosmetic is deemed to be misbranded:
1. if it contains a colour which is not prescribed; or
2. if it is not labelled in the prescribed manner; or
3. if the label or container or anvthing accompanying the cosmetic
bears any statement which is false or misleading in any particular.
"Spurious cosmetics" Acosmetic is deemed to be spurious:
1. if it is imported under a name which belongs to another cosmetic;
or

2. if it is an imitation of, or is a substitute for, another cosmetic or

resembles another cosmetic in a manner likely to deceive or bears
upon it or upon its label or container the name of another
cosmetic, unless it is plainly and conspicuously marked so as to
reveal its true character and its lack of identity with such other
cosmetic; or
3. if the label or container bears the name of an individual or a
company purporting to be the manufacturer of the cosmetic, which
individual or company is fictitious or does not exist; or
4. if it purports to be the product of a manufacturer of whom it is
not truly a product.
Drugs and Cosmetics Rules have been divided into 18 parts each dealing
with a particular subject. There are 2 schedules to the Act and 30
schedules to the Rules, which are as follows:-
Schedules to the Act
First Schedule-Names of books under Ayurvedic and Sidha systems.
Second Schedule-Standard to be complied with by imported drugs and
by drugs manufactured for sale, sold, stocked or exhibited for sale or
distributed.
 31
Ch-4 DRUGS AND COSMETICS ACT AND RULES

crhedules to the Drug Rules

A- Proforma for application for the licenses, issue and renewal of
(icenses, for sending memoranda under the Act.
Rates of fee for test or analysis by the Central Drugs Laboratory or
B
the Government Analyst.
ion
C- List of biological and special products whose import, sale, distribu
tion and manufacture are governed by special provisions.
C- List of other special products whose import, sale, distribution and
manufacture are governed by special provisions.
D List of drugs exempted from the provisions of import of drugs.
Es -List of poisonous substances. under the Ayurvedic (including Sidha)
and Unani systems of medicine.
FÖ) - Space, equipment and supplies required for a bloodbank.
()-Minimum requirement for grant of license to procure blood compo
nents from whole human blood.
f Part I - Provisions applicable to the production of bacterial and viral
vaccines.
Part II Provisions applicable to the production of all sera from living
animals.
Part III Provisions applicable to the manufacture and standardization
of diagnostic agents (bacterial origin).
F.-Standards for surgical dressings.
Fa-Standards for sterilized umbilical tapes.
FF -Standards for ophthalmic preparations.
G List of substances that are required to be used only under
medical
Supervision and which are to be labelled accordingly.
H- List of prescription drugs,a
J- Diseases or ailments which a drug may not purport to prevent or
Cure.
manufacture
K- Drugs exempted from certain provisions relating to the
of drugs.
M-Good Manufacturing Practices (GMP) requirements of factory premises,
plants and equipment.
M - Requirements of factory premises etc. for manufacture of homeo
pathic preparations.
M2 -Requirements of factory premises for the manufacture of cosmetics.
 32 PHARMACEUTICAL JURISPRUDENCE
Ma -Requirements of fctory premises for manufacture of medical devicec
N- List of minimum equipment for efficient running of a pharmacy.
0-Standards for disinfectant fluids.
P- Life periods of drugs.
P-Pack sizes of drugs.
QPart I List of dyes, colours and pigments permitted in cosmetics and
soaps.
Part II- List of colours permitted in soaps.
R-Standards for condoms made of rubber latex intended for single use
and other mechanical contraceptives.
R1 Standards for medical devices.
S- Standards for cosmetics.
I- Requirements of factory premises and hygienic conditions for
Ayurvedic (including Sidha) and Unani drugs.
U- Particulars to be shown in manufacturing, raw material and analyti
cal records of drugs.
UjParticulars to be shown in manufacturing, raw material and analyti
cal records of cosmetics.
V- Standards for patent or proprietary medicines.
W- List of drugs which are to be marketed under generic names only.
X- List of drugs whose import, manufacture and sale, labelling and
packaging are governed by special provisions.
Y Requirements and guidelines on clinical trials for import and
manufacture of new drugs.

SALE OF DRUGS
Under the Sale of Goods Act the term 'sale' is defined as 'a contract for
sale of goods is a contract whereby the seller transfers or agrees to transfer
the property in goods to the buyer fora price'. The drugs reach the
consumers from the manufacturers by retail through shopkeepers. Manufac
turers generally sell their goods to the stockists who in turn sell the same
to the shopkeepers.This transaction between the stockists and the
shopkeepers is thewholesale. Under the Drugs (Prices Control) Order,
1987 wholesaler means adealer or his agent, or a stockist appointed by a
manufacturer or an importer for the sale of his drugs to a retailer; and a
retailer means a dealer carrying on the retail business of sale of drugs to
Customers.
Ch.k DRUGS AND COSMETICS ACT AND RULES 33

For the purposes of issuing sale licences the drugs are divided into the
following categories:
1. Drugs other than those specified in Schedule C, C, and X;
2. Drugs specified in Schedule Cand C, but excluding X; and
3. Drugs specified in Schedule X.
The Rules also provide for the wholesale and retail sale of these drugs.
The wholesate and distribution of drugs specified in Schedule Cand Cj and
other than those specified in Schedule C, C, and Xis also permitted by
motor vehicles provided a licence is taken. All the three categories of
drugs can also be sold on retail. Restricted licences for the sale of drugs
other than those specified in Schedule Cand Cexcluding Xare also issued
to the itinerant vendors and other deaters who do not engage the services
of a 'qualified person.
"Registered pharmacist" means a person who is registered pharmacist as
defined in clause (i) of Section (2) of the Pharmacy Act, 1948.
An original licence or a renewed licence to sell drugs remains valid upto
31st December of the year following the year in which it is granted or
renewed. The licence shall be deemed to have expired if application for its
renewal is not made within six months after the expiry. In the event of
any change in constitution of a licensed firm, the licensee should inform
the licensing authority. Licences of such firms remain valid for a maximum
period of 3 months from the date of change unless in the meantime a fresh
licence has been obtained.
The licensing authority must be satisfied that the premises in respect of
which the licence is to be granted are adequately equipped with proper
accommodation for preserving the properties for drugs to which licence
applies and it is in charge of a person competent to supervise and control
the sale, distribution and preservation of drugs.
In respect of an application for the grant of a licence for the wholesale
of drugs other than those specified in Schedule C, C but excluding X, the
licensing authority shall satisfy himself that the premises in respect of
which alicence is to be granted are:
1. of an area of not less than 10 sq. metres; and
2. in the charge of a competent person, who is a registered pharma
cist or who has passed the matriculation examination or its
equivalent with 4 years experience in dispensing of drugs.
Wholesale of Drugs
(1) Drugs other than those specified in schedule C, C and X: The
licence issued in Form 208 is subject to the following conditions in
 PHARMACEUTICAL JURISPRUDENCE
34
-
general conditions discussed earlier:
addition to the
displayed in a prominent place open to th
be
1. The licence should
public.
comply with provisions of the Drugs and
2. The licensee should and the Rules thereunder in force.
CosmeticsAct, 1940
be purchased only from a duly licensed dealer o
3. Drugs should
manufacturer.
made to a person holding requisite licence to sell o
4. Sale can be not apply to the sale of
distribute the drugs. However this shall
any drugs to -
an officer or authority purchasing on behalf of Government: or
(a)
research institution or a
(b) a hospital, medical, educational or patients; or
RMP for the purpose of supply to his
biscuits and other
(C) a manufacturer of beverages, confectionalare required for pro
non-medical products, where such drugs
cessing their products.
(2) Other than schedule C and C drugs from a motor vehicle : The
licence issued in Form 20BB is subject to the following conditions in
addition to the general conditions discussed earlier:
1. The licence should be displayed in a prominent part of the vehicle.
2 to 4.As for drugs other than those specified in Schedule C, CH and x.
5. The licensee should inform the licensing authority in writing in the
event of any change in the ownership of the vehicle specified in
the licence within 7 days of such change.
(3) Schedule Xdrugs : The licence issued in the Form 20G is subject
to the following conditions in addition to the general conditions discussed
earlier:
1. The licence should be displayed in a prominent part of the
premises open to the public;
2. The licensee should comply with the provisions of the
Drugs and
Cosmetics Act, 1940 and the Rules thereunder; and
3. Drugs should be purchased from a duly licenced
dealer or manufac
turer;
4. The licensee should forward to the licensing
authority copies of the
invoices of sale made to the retail dealers; and
5. Sale can be made to a person
holding
distribute drugs specified in Schedule X.requisite licence to sell or
This however does not
apply to the sale of any drug to -
 35
Ch-4 DRUGS AND COSMETICS ACT AND RULES

(a) an officer or authority purchasing on behalf of government, or

(b) a hospital, medical, educational or research institution, nurs
ing home, RMP for the purpose of supply to its/his patients or
manufacturers holding a licence to manufacture drugs contain
ing the rugs specified in Schedule X.
(4) Drugs specified in schedule C&C, but not included in schedule
X: The licence issued in the Form 21B is subject to the following
conditions in addition to the general conditions discussed earlier:
1. The licence should be displayed in a prominent part of the
premises open to the public.
2. The licensee should observe precautions prescribed for stocking or
sale of drugs.
3. For the sale of each additional category of drugs the permission
shoutd be obtained from the licensing authority.
4. No sale of any drug should be made for the purpose of resale to
person not holding the requisite licence to sell or distribute the
drugs. Provided that this shall not apply to the sale of any drug
to
(a) an officer or authority purchasing on behalf of government; or
(b) a hospital, medical, educational or research institution, or a
RMP for the purpose of supply to his patients; or
() a manufacturer of hydrogenated vegetable oils, beverages,
confectionery and other non-medicinal products, where such
drugs are required for processing their products.
(5) Drugs specified in schedule C & C1 from motor vehicle : The
licence issued in the Form 21BB is subject to the following conditions in
addition to the general conditions discussed earlier:
1. The licence should be displayed in a prominent place on the
vehicle.
2. Precautions prescribed by the licensing authority for the storage of
drugs should be observed.
3. For the sale of additional categories of drugs not included in the
licence, the licensee should take permission from the licensing
authority.
4. Drugs should be purchased from a duly licenced manufacturer.
5. Wholesale for resale can be made to a person holding requisite
licence to sell or distribute drugs. Provided that this does not
apply to the sale of any drug to:
 36 PHARMACEUTICAL JURISPRUDENCE
behalf of Government.
(a) an officer or authority purchasing on institution, or
(b) a hospital, medical, educational or research
or
RMP for the purpose of his patients;
(c) a manufacturer of hydrogenated vegetable o1ls, beverages
confectionary and other non-medicinal products.
6. The licensee should inform the licensing authority in writing in the
event of any change in the ownership of the vehicle specified in
the licence within 7 days of such change.
Retail Sale
For retail sale two types of licences are issued, () General and
(i) Restricted. General licences are granted to persons ho have premises
for the business and who engage the services of a Qualified Person' to
supervise the sale of drugs ana do the compounding and diapensing.
Licences for retail sale of drugs other than those specified in Sch. C, C,
and X are issued in Form 20, for druqs specified in Sch. C, CË excluding
those specified in Sch. Xin Form 21 and for Sch. X drugs in form 20F.
Conditions:
1. The licence should be displayed in a prominent place in a part
of
the premises open to the public.
2. The licensee should comply with the
provisions of Drugs and
Cosmetics Act and Rules thereunder in force.
3. Any change in the qualified staff in charge
should be reported by
the licensee to the licensing authority within one
month.
4. Drugs should be purchased only from a duly
manufacturer. licensed dealer or
5. Any change in the constitution of the
licensed figm should be
informed to the licensing authority within three months and in the
meantime a fresh licence should be obtained in the name of the
firm with the changed constitution.
6. Precautions prescribed by the
Sch. C, and C drugs should belicensing authority for the storage of
observed.
7. For the sale of additional
C excluding X, the licensee categories of drugs listed in Sch. Cand
must take prior permission of the
licensing authority.
Restricted Licences The
than those specified in Sch. C,licences for the restricted sale of drugs other
C1 and Xand those
issued in the Form 20A andspecified
C, but not in Sch. Xare in Sch. C, and
21A respectively.
 ACT AND RULES 37
Ch-4 DRUGS AND COSMETICS
Restricted licences can be given to;
does not require
1. dealers or persons in respect of drugs whose sale
the supervision of a registered pharmacist;
agents
2. itinerant vendors in exceptional cases for bonafide travelling
of firms dealing in drugs; or
a licensed dealer for
3. to a vendor who purchases drugs fromwhere other channels of
distribution in sparsely populated areas
distribution of drugs are not available.
Restricted licences may also be issued to a travelling agent of a firm for
practitioners or dealers,
the special purpose of distribution to the medical specified in Sch. C.
for supply of biological and other special products
Travelling agents of licensed manufacturers, agents of such manu
the free
facturers and importers of drugs need not take licences for
distribution of samples of medicines to any member of medical profession,
hospitals, dispensaries and the medical or research institutions.
Conditions for Restricted Licence
1. The licensee must have adequate premises equipped with facilities
for the proper storage of drugs to which the licence applies
provided that this condition does not apply to vendors.
2. The licence should be displayed in a prominent place in a part of
the premises open to the public or should be kept on the person of
vendor who shall produce the same on demand by an Inspector or
other officer authorised by the State Government in this behalf.
3. The licensee should comply with the provisions of the Drugs and
Cosmetics Act and Rules thereunder in force.
4. Drugs should be purchased only from a duly licensed dealer or
manufacturer.
5. The licensee can deal only in such drugs as can be sold without the
supervision of a registered pharmacist.
6. If the licensee be a vendor having no fixed place of business, he
should buy drugs from dealers specified in his licence.
7. Drugs should be sold in their original containers.
Before granting the restricted licence the licensing authority may take
into consideration the number of licences granted in a locality during last
three years and the occupation, trade or business of the applicant.
Dispensing and compounding of drugs For the purposes of this Act
and the Rules, "Pharmacy" means and includes every store or shop or
other place (i) where drugs are dispensed; or (ii) where drugs are prepared;
 PHARMACEUTICAL JURISPRUDENCE
38
or (iii) where prescriptions are compounded; or (iv) which byysign, symbol
or indication gives the impression that the operations mentioned in (i),
(ii) and (ii) are carried in the premises; or (v) which has upon it or
displayed within it or affixed to or used in connection with it a sign
bearing the word(s) Pharmacy, 'Pharmacist, Dispensing Chemist', or P
rmaceutical Chemist, or (vi) which is advertised in these terms.
The premises licensed for the retail sale of drugs may be described ae
(1) "Drug Store" where the licensees do not engage the services of a
'qualified person' or tegistered pharmacist'; or
(ii) "Chemists and Druggists" where licensees employ the services of a
registered pharmacist' but do not maintain a Pharmacy for com
pounding against prescriptions; or
(ii) "Pharmacy", "Pharmacist", "Dispensing Chemist", or "Pharmaceuti.
cal Chemist", where the licensees employ the services of a 'qualified
person' and maintain a Pharmacy for compounding against pre.
scriptions.
In granting licence for a pharmacy the licensing authority may
regard to () average number of licences granted during the have
3 years immediately preceding: and (i) the period of
ordinarily carried out by such applicant duringoccupation, trade or business
the preceding 3years.

PHARMACY
This part is most vital to the Diploma
pharmacists who may work in
hespitals, dispensaries or chemist and druggist
equipment for the efficient running of a Pharmacy shops. The minimum
Schedule N of the Drugs and Cosmetics Rules, 1945. are laid down in
Premises The entrance of a Pharmacy should vear an
"Pharmacy". The premises of Pharmacy should be inscription
private use. The premises should be well built, separated from rooms for
and, of sufficient dimensions so that all dry, well-lit and ventilated
goods especially medicaments and
poisons can be kept in a clearly visible and
be not lessappropriate
of dispensing department manner. The area
pharmacist with should than 6 sq. metres for one
The height of the additional 2 sq. metres for each
premises should be at least 2.5 additional pharmacist.
The floor of the Pharmacy metres.
should
should be plastered or tiled or oil be smooth and washable. The walls
painted.
water should also be available. The Ample quantity of qood quality
.separated by a barrier to prevent the dispensingof department should be
admission the public.
Ch-4 DRUGS AND COSMETICS ACT AND RULES 39

Furniture Drugs, chemicals and medicaments shall be kept in a room

appropriate to their properties and in such special containers as will
orevent any deterioration of the contents. Drawers, glasses and other
containers used for keeping medicaments shall be of suitable ize and
apable of being closed tightly to prevent the entry of dust. Every
antainer shall bear a label of appropriate size, easily readable with names
of medicaments as given in the Pharmacopeias.
A Pharmacy shall be provided with a dispensing bench, the top of
which shall be covered with washable and impervious material like stainless
steel, laminated or plastic etc.
A Pharmacy shall be provided with a cupboard with lock and key for the
storage of poisons and shall be clearly marked with the word "POISON" in
red letters on a white background.
Apparatus A Pharmacy shall be provided with the following minimum
apparatus and books necessary for making of official preparations and
prescriptions:
Balance, dispensing, sensitivity 30 mg.
Balance, counter, capacity 3 kg, sensitivity 1 g.
Beakers, lipped, assorted sizes.
Bottles, prescription, ungraduated, assorted sizes.
Corks, assorted sizes, and tapers.
Cork extractor.
Evaporating dishes, porcelain.
Filter paper.
Funnels, glass.
Litmus paper, blue and red.
Measure glasses, cylindrical, 10 ml, 25 ml, 100 ml, and 500 ml.
Mortars and pestles, glass.
Mortars and pestles, wedgewood.
Ointment pots with bakelite or suitable caps.
Ointment slab, porcelain.
Pipettes, graduated, 2 ml, 5 ml and 10 m.
Ring, stand (retort) iron, complete with rings.
Rubber stamps and pad.
Scissors.
Spatulas, rubber or vulcanite.
Spatulas, stainless steel.
Spirit lamp.
Glass stirring rods.
Thermometer, 0° to 200°C.
Tripod stand.