Drug and cosmetic act 1940

Drug & Cosmetic Act
1940 & Rules 1945
Dr. Anil Pethe
Shobhaben Pratapbhai Patel School of Pharmacy &
Technology Management,
SVKM’S NMIMS, Mumbai

Objective
 The D&C Act was passed in 1940 (10th
April 1940), with the main
object to
 Import,
 Manufacture,
 Distribution &
 Sale of drug & cosmetics.
 The act regulates the import of drugs in India, so that no
substandard or spurious drug will enter into our country.
 The act prohibits the manufacture of substandard or spurious
drug in the country.
 The act provide for the control over the sale & distribution of
drugs by only trained & qualified persons.
 The act also provide for the control over the manufacture, sale
& distribution of Ayurvedic, Siddha, Unani & Homeopathic
drugs.

Objective (cont.)
 Certain provisions of the act regulates the import, manufacture,
sale & distribution of cosmetics.
 To have regular inspection of licensed premises by drug
inspectors.
 To have control over the standards of drugs & cosmetics by
taking samples & analyzing them at approved laboratories.
 To provide special provisions to regulate the preparation,
standardization & storage of biological & special products.
 To prescribe the manner of labeling & packing of the various
classes of drugs & cosmetics.

Chapters of the act
 Chapter I: Introduction & Definitions
 Chapter II: DTAB, DCC, CDL
 Chapter III: Import of drugs & Cosmetics
 Chapter IV: Manufacture, Sale & distribution of drugs &
cosmetics
 Chapter IVA: Provisions relating to Ayurvedic, Siddha &
Unani drugs.
 Chapter V: Miscellaneous

Drug
“drug” includes—
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;
Such substances (other than food) intended to affect the
structure or any function of human body or intended to be used
for the destruction of (vermin) or insects which cause disease in
human beings or animals,
All substances intended for use as components of a drug
including empty gelatin capsules; and
Such devices intended for internal or external use in the
diagnosis, treatment, mitigation or prevention of disease or
disorder in human beings or animals,

Cosmetic
 “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

Ayurvedic, Siddha, or Unani drug
Includes all medicines intended for internal or external use
for or in the diagnosis, treatment, mitigation or prevention of
disease or disorder in human beings or animals, and
manufactured exclusively in accordance with the formulae
described in, the authoritative books of Ayurvedic, Siddha and
Unani systems of medicine, specified in the First Schedule.

Standards of quality:
Standards of quality in relation to a drug means that the drug
complies with the standard set out in the Second Schedule and in
relation to a cosmetic that the cosmetic complies with such
standards as may be prescribed.

Misbranded drugs:
A drug shall be deemed to be misbranded—
 (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 statement, design or device which makes any false
claim for the drug or which is false or misleading in any
particular.

Misbranded cosmetic:
A cosmetic shall be deemed to be misbranded—
If it contains a colour which is not prescribed; or
If it is not labelled in a prescribed manner; or
If the label or container or anything accompanying the cosmetic
bears any statement which is false or misleading in any particular.

Adulterated drugs:
A drug shall be deemed to be adulterated
 If it consists, in whole or in part, of any filthy, putrid or
decomposed substance; or
 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
 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
 If it bears or contains, for purposes of colouring only, a colour
other than one which is prescribed; or
 If it contains any harmful or toxic substance which may render it
injurious to health; or
 If any substance has been mixed therewith so as to reduce its
quality or strength.
e.g. supply of cheap cottonseed oil in stead of olive oil

Spurious drugs:
A drug shall be deemed to be spurious—
 If it is imported under a name which belongs to another drug; or
 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
 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
 If it has been substituted wholly or in part by another drug or
substance; or
 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

Spurious cosmetic:
A cosmetic shall be deemed to be spurious if
If it is imported under the name which belongs to another
cosmetic; or
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 or conspicuously marked
so as to reveal its true character and its lack of identity with
such other cosmetic; or
If the label or the container bears the name of an individual
or company purporting to be the manufacturer of the
cosmetic, which individual or company is fictitious or does not
exist; or
If it purports to be the product of a manufacturer of whom it
is not truly a product.

New drug:
Shall mean and include :-
 A new substance of chemical, biological or biotechnological origin, in bulk
or prepared dosage form; used for prevention, diagnosis, or treatment of
disease in man or animals; which except during local clinical, trials, has not
been used in the country to any significant extent and which has not been
recognized in the country as effective and safe for the proposed claims.
 A drug already approved by the licensing authority for certain claims which
is now proposed to be marketed with modified or new claims, namely
indications, dosage form (including sustained release dosage form) and
route of administration.
 A fixed dose combination of two or more drugs, individually approved
earlier for certain claims, which are now proposed to be combined for the
first time in a fixed ratio, or if the ratio of ingredients in an already
marketed combination is proposed to be changed, with certain claims, viz
indications, dosage, form (including sustained release dosage form) and
route of admin.
For the purpose of this rule :-
 All vaccines shall be new drugs unless certified otherwise by the licensing
authority
 A new drug shall continue to be considered as new drug for a period of 4
yrs from the date of its first approval or inclusion in the I. P. whichever is

Government Analyst:
Means
In relation to Ayurvedic, Siddha or Unani drugs a
person appointed by central or state govt. under
section 33-F
In relation to any other drugs or cosmetics a person
appointed by central or state govt. under section 20

Inspector:
Means
 In relation to a Ayurvedic, Siddha or Unani drug, an
Inspector appointed by the Central Government or a
State Government under section 33G; and
 In relation to any other drug or cosmetics, an Inspector
appointed by the Central Government or a State
Government under section 21

Manufacture:
Manufacture in relation to any drug or cosmetic 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, or
the packing of any drug or cosmetic, in the ordinary
course of retail business; and “to manufacture” shall be
construed accordingly;

Patent or proprietary medicine:
Means
In relation to Ayurvedic, Siddha or Unani systems of medicine
all formulations containing only such ingredients mentioned in
the formulae described in the authoritative books of Ayurveda,
Siddha or Unani systems of medicine specified in the First
Schedule, but does not include a medicine which is administered
by parenteral route and also a formulation included in the
authoritative books as listed in the First Schedule;
In relation to any other systems of 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 authorised in this behalf
by the Central Government after consultation with the Drugs
Technical Advisory Board constituted under section 5.

Homeopathic medicines:
Include
 any drug which is recorded in Homeopathic provings or
therapeutic efficacy of which has been established through long
clinical experience as recorded in authoritative homeopathic
literature of India and abroad and which is prepared according to
the the techniques of Homeopathic Pharmacy and covers
combination of ingredients of such homeopathic medicines but
does not include a medicine which is administered by parenteral
route.

Schedules to the Act
First Schedule: List of Ayurvedic, Siddha & Unani books
Ayurvedic books
 Charak Samhita,
 Sushrut Samhita,
 Vaidya Chintamani
 Ayurveda Chintamani,
 Arya Bhishak
 Ark Prakasha
 Siddha Books
 Siddha vaidya Thiratu,
 Nagmuni (700),
 Brahma muni Karukkadai (300),
 Pulippani (500),
 Bhogar (700)
 Unani books
 Karabadin Quadri,
 Karabadin Kabir,
 Karabadin Azam
 Karabadin Jaddid,
 Al Karabadin

 Second Schedule
Standards to be complied with by imported drugs &
by drugs manufactured for sale, sold, stocked or
exhibited for sale or distributed.

Schedules to the Rule
 A: List of forms for making applications for issuing
licences, granting licences, sending memorandum
 B: Fees for test or analysis by the Central Drugs
Laboratory

 C: Deals with biological products such as sera antigens, toxin,
antitoxin, Vaccines for parenteral injections, solution of serum
proteins intended for injection, Insulin etc
 C1: Special products such as fish liver oil, ergot preparations, drugs
belonging to digitalis groups, adrenaline, Liver extract, vitamines,
hormones

 D: Classes of exempted drugs which are exempted
from certain provisions applicable to import of drugs
E.g. Skimmed milk, powdered milk fortified with
vitamins, farex, oats, ginger, pepper, cummins etc

Schedule K
K:List of drugs exempted from certain provisions applicable to
manufacture of drugs and sale of drugs
Class of Drugs is not sold for medicinal use and that each container is
labelled conspicuously with the words “NOT FOR MEDICINAL USE”.
The medicines that continue to be under the 'household remedy'
category include Paracetamol tablets, Analgesic Balms, Antacid
Preparations, Calcium preparations with or without Vitamin D, Gripe
Water for use of infants, Inhalers (containing drugs for treatment of
cold and nasal congestion), Syrups lozenges, pills and tablets for
cough, cold or sore throat.
However, these drugs should not contain any substance specified in
Schedules G, H or X of D&C Act and Rules. The shopkeepers are also to
ensure that the drugs are sold in the original unopened containers of
the licensed manufacturers.
Note- Aspirin and Quinine Sulphate have been removed from this
schedule

Mashelkar Committee recommendations
 The Committee on Drug Regulatory System headed by the Chief Dr
Mashelkar.
 suggested to expand the scope of Schedule K to include OTC drugs.
 The ultimate objective is to enhance public access to commonly required
medicines but at the same time ensuring quality of delivery.
OTC Drugs
 The phrase “OTC” has no legal recognition in India, all the drugs not
included in the list of prescription-only drugs” are considered to be non-
prescription drugs (or OTC drugs).
 OTC Drugs means drugs legally allowed to be sold “Over The Counter”‟
by pharmacists, i.e. without the prescription of a Registered Medical
Practitioner.
 Prescription-only drugs are those medicines that are listed in Schedule H
and X and Schedule G

Ayurvedic (OTC) Medicines
 OTC drugs registered as “Ayurvedic Medicines”
containing natural / herbal ingredients
 Ayurvedic drugs are manufactured under a
manufacturing license issued by the Ayurvedic State
Licensing Authorities. However, they do not require a
drug sale license and can be sold freely by non-
chemists.
 Largest OTC brands in India are registered as
“Ayurvedic Medicines because of their plant-based‟
natural active ingredients

Categories with OTC potential
 Vitamins and minerals;
 Health tonics,
 Cough suppressants likes vicks 44
 Gastrointestinal drugs like Gas X
 Analgesics
 Dermatological preparations
 Herbal / Ayurvedic medicines

SCHEDULE E & E1
[Omitted as per GOI Notification
No.G.S.R. 462(E)
dt 22-6-1982]
SCHEDULE E(1): List of Ayurvedic,
Siddha, and Unani poisons
Ex- Snake poison,
arsenic,mercury,CuSo4
Dhatura, Bhang, Ganja etc

Schedule F and F (I)
 F:Provisions applicable to blood banks (Requirements
and licencing process)
 F (I) : Provisions applicable to other biological and
special products such as vaccines, antigens, diagnostic
antigens, tuberculin, etc. regarding their production,
testing, storage, packing, etc.

Schedule F (II)
 Standards for Surgical dressings and bandage cloth.
Schedule F (III)
 Standard for umbilical tapes.

Schedule FF
 Standards for ophthalmic preparations.
F F

Schedule G
 List of substances required to be taken only under
supervision of RMP
 Medicines listed as schedule G medicines carry on the label a
caution
 Caution – “it is dangerous to take this preparation except
under medical supervision”. conspicuously printed and
surrounded by a line within which there should be no other
words.
 It is necessary to make proper bill of sale.
 Records of purchase and sale of these medicines must be
maintained for a period of 2 years
 Eg: L asperginase,Bleomycin, Busulphan, chlorambucil,
chlorthiazide, chlorpropamide, doxorubicin, ethosuximide,
Metformin, Insilin all types,Hydroxyurea, Mercaptopurines etc

Schedule H (Drugs & cosmetics (2nd
amendment)
Rules 2006)
 Prescription drugs which are required to be sold by retail
only when a prescription by RMP
 Drugs come under Schedule H should be labelled with the
symbol Rx and conspicuously displayed on the left top corner
of the label.
 Drugs specified in Schedule H, and comes within [Narcotic
Drugs and Psychotropic Substances Act, 1985 labelled with the
symbol NRx which shall be in red and conspicuously displayed
on the left top corner of the label.
 Examples-Alprazolam, Allopurinol, Amikacin, Atenolol
,Acyclovir, Buspirone, Azathioprine, Captopril, Carbidopa,
Clindamycin, Cimetidine, Ciprofloxacin,Cefuroxime,Diclofenac,
Glimepiride, diazepam etc.

For monitoring use and misuse of antibiotics
 Schedule H of the drug and cosmetics act contains a list of
536 drugs which are required to be dispensed on the
prescriptions of a registered medical practitioner.
 In order to have separate regulation to check unauthorized
sale of antibiotics, a separate schedule as Schedule H1 was
introduced under the Drugs and Cosmetics (4th
amendment )
rules 2013 to regulate sale of antibiotics exclusively.
 Under schedule H1, drug formulations should be labelled with
symbol Rx in red and conspicuously displayed on left corner
of the label with the following words in box with red border
 Warning- It is dangerous to take this preparation except in
accordance with the medical advice. Not to be sold by retail
without the prescription of a RMP.

Drugs under schedule
H are omitted
Drugs under Schedule
H1
Alprazolam Thiacetazone Alprazolam Diazepam
Cefdinir zolpidem Cefdinir Codein
Cefepime Ethambutol HCl Cefepime Cycloserine
Clofazamine Meropenem Cefixime Ertapenem
Codein Ethionamide Cefoperazone Doripenem
Diazepam Nitrazepam Imipenem Ethambutol
HCl
Cefpirone Pentazocine Midazolam
Gemifloxacin
Midazolam Sparfloxacine Cefpirome Rifampicin
Tramadol Chlordaizepoxide Ceftriaxone Tramadol

Schedule J
List of diseases and ailments which a drug may not
claim to prevent or cure.
Some of the diseases and ailments under this schedule are
1. AIDS
2. Angina Pectoris
3. Appendicitis
4. Arteriosclerosis
5. Baldness
6. Blindness
7. Bronchial Asthma
8. Cancer and Benign tumour
9. Cataract
10. Change in colour of the hair and growth of new hair.
11. Change of foetal sex by drugs.
(almost 51 ailments mentioned on Schedule J)

Schedule M
Deals with the Good Manufacturing Practices
(GMP) and requirements of premises , plant and
equipment.
Part I deals with GMP & Factory premises.
Part II deals with plant and equipment.

Schedule M1
 Prescribes in detail requirements of factory premises for
the manufacture of Homeopathic drugs.
Schedule M- II
 Prescribes requirements of factory premises for
manufacture of cosmetics.
Schedule M- III
 Prescribes requirements of factory premises
for manufacture of medical devices.

Schedule T
 Requirements of factory premises and hygienic
conditions for Ayurvedic and Unani drugs.

Schedule N
 List of minimum equipment for efficient running of
pharmacy

Schedule O
 Standards for disinfectant fluids

Schedule P
life period of drug.
Period in months (unless otherwise specified) between date of
manufacture and date of expiry which the labelled potency period of
the drug should not exceed under the conditions of storage Specified.
The schedule includes antibiotics,vitamins,insulin preparation, normal
human plasma, sera toxins, toxoids , other toxins , anti-toxins,
miscellaneous drugs
Schedule P Life period of drugs
Name of
Drug
Period in Month Conditions of storage
Adriamycin 30 In a cool place
Ampicillin Na 36 In cool place
Carbenicillin
Sodium
Powder
24 At temperature not
exceeding 5°C

Schedule P 1
Pack size of certain drugs.
It gives the names of drugs, along with the dosage form and the
pack size.
No other pack size than the one listed is allowed to be
marketed.
Examples of a few drugs under this schedule:
Schedule P- I pack size of the drug
Name of
Drug
Dosage form Pack size
Albendazole suspension 10ml
Atenolol Tablet 14 tabs
Piperazine Granules 5 gm

Schedule Q
 List of coaltar colours permitted to be used in drug
and cosmetics
 No drug should contain a colours other than specified below :
 (1) Natural Colours
 Carotene, Chlorophyll, Red Oxide of Iron, Yellow Oxide of
Iron, Titanium Di-oxide, Black Oxide of iron
 (2) Artificial Colours Caramel
 (3) Coal Tar Colours

Schedule R
 R- Standards for condoms made up of rubber latex
intended for single use and other mechanical
contraceptives
Eg. Condom, Cu- T
Schedule R-1
 standards for medical devices.

Schedule S –
 Standards for cosmetics
 The following cosmetics in finished form should conform to the
Indian Standards specifications laid down from time to time by the
Bureau of Indian Standards (BIS)].
1.Skin Powders
2. Skin Powder for infant
3. Tooth Powder
4. Toothpaste
5. Skin Creams
6. Hair Oils

Schedule U & U1
U- Particulars to be shown in manufacturing and
analytical records of drugs
U (I)- Particulars to be shown in manufacturing records
of cosmetics

Schedule V
Standards for patent and proprietary medicines and for
patent and proprietary medicines containing
vitamins

Schedule W
 List of drugs which shall be marketed under generic
name only
 This includes only five drugs that shall be marketed under
generic names only:
 Analgin
 Aspirin and its salt
 Chlorpromazine and its salt
 Ferrous sulfate
 Piperazine and its salts
 (Schedule W) – Inserted as per G.O.I. Notificiation No. GSR 27(E)
dt 17.1.1981 and deleted as per G.O.I. Notification No. GSR
94(E) dt 8.2.2000.

Schedule X
List of habit forming, psychotropic, and other such drugs
Schedule X contains list of drugs which:
Need discretion while dispending and pharmacist should ensure that
this drugs are not sold without prescription
Have a waning mentioned on a label ‘Schedule X drug’ – Warning : to
be sold on retail on prescription of a registered medical practitioner
only. The label will also have a symbol ‘XRx’ in red & conspicuously
displayed on the top left corner of the table
After dispending the drug the pharmacist must Stamp & retain the
prescription
Maintain & record purchase & sale of the drug and Preserve it for a
period of 2 years from the date of transactions
Examples of few drugs under schedule X
 1)Amobarbital
 2)Amphetamines
 3)Dexamphetamines
 4) Glutethimide
 5)Methylphenidate etc.

Schedule Y
Requirements and Guidelines for clinical trials, import,
and manufacture of new drugs
 The schedule covers details like :
Chemical and pharmaceutical information
Animal tests, toxicology and pharmacology
Clinical Trails
 Nature of trials
 Permission for trials
 Responsibility of sponsor / Investigator

Administrative Bodies
 Advisory
 Drug Technical Advisory Board (DTAB)
 Drug Consultative Committee (DCC)
 Analytical
 The Central Drug Laboratory (CDL)
 Drug Control Laboratories in the state (DCL)
 Government Analyst
 Executive
 Licensing Authorities (central & state)
 Drug Inspectors
 Custom Collector

Drug Technical Advisory Board (DTAB)
 Central govt. appoints DTAB to advice the central &
state govt. on technical matters arising out of the
administration of this act & to carry out the other
functions assigned to it by this act.

Constitution of DTAB
Ex-officio members
1. Director General of Health Services (chairman of the board)
2. Drug Controller of India
3. President, Pharmacy Council of India
4. President, Medical Council of India
5. Director, Central Drug Laboratories, Kolkata
6. Director, Central Drug Research Institute, Lucknow
7. Director, Central Research Institute, Kasuali.
8. Director, Indian Veterinary Research Institute, Izzatnagar
Nominated Members
1. One person from pharmaceutical Industry
2. Two Govt Analyst
3. Two persons from among the persons who are in-charge of the drug
control organization in the state.

Elected Members
1.One teacher in pharmacy, pharmaceutical chemistry or
Pharmacognosy from the staff of University or affiliated college
elected by the executive Committee of Pharmacy Council of India
2.One teacher in medicine or therapeutics from the staff of
University or affiliated college elected by the executive Committee
of Medical Council of India
3. One person elected by the central council of Indian
Pharmaceutical Association.
4.One person elected by the central council of Indian Medical
Association.
5.One Pharmacologist, elected by the governing body of the Indian
Council of Medical Research.
The nominated & elected members hold office for 3 years & are
eligible for re-nomination or re-election.
The central govt. appoints a Secretary of the board & other
clerical staff.

Drugs Consultative Committee
 The Central Government may constitute an advisory committee
to be called “the Drugs Consultative Committee” 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.
Constitution of DCC:
 The Drugs Consultative Committee shall consist of
 two representatives of the Central Government to be nominated by that
Government and
 one representative of each State Government to be nominated by the
State Government concerned.
 The Drugs Consultative Committee shall meet when required to
do so by the Central Government and shall have power to
regulate its own procedure.

Functions of Central Drug Laboratory (CDL)
 To analyze the samples of drugs or cosmetics sent to
it by
 a) Custom Collector or any authorized officer
 b ) by Court
 To carry out such other duties as may be assigned to
it by Central govt. or state govt. with the permission
of central govt. after consultation with DTAB.
 In case of some drugs like biological &
microbiological tests are not carried out in the CDL at
Kolkata hence the test or analysis of such samples or
functions of CDL is carried out at other labs or
institution.

Products Lab
sera, vaccines, toxins, antigen,
antitoxins, sterilized surgical
sutures & ligatures etc.
Central Research Institute, Kasauli
sera, vaccines, toxins, antigen,
antitoxins for veterinary use
Indian Veterinary Research Institute,
Izzatnagar
Oral Polio vaccines  Vaccine testing laboratory of CRI
kasuali.
 National Inst. Of Communicable
diseases
 National Inst. Of Vaccines, Pune
VDRL Antigen Laboratory of Serologist & Chemical
Examiner to the Govt. of India
Condoms Indian Pharmacopoeial Laboratory,
Gaziabad
IUD & Felopian rings Dept. of Biochemical Engg. IIT, New Delhi

Drug Control Laboratories in the State
 Every state has a laboratory for the analysis & testing
of the drugs & cosmetics manufactured or sold in that
particular area.
 Samples sent by D.I. are analyzed by such laboratories.
 Also analyzed the drugs sent by any person or
purchaser on payment of necessary fee.

Qualification of Govt. Analyst
 A graduate in medicine or science or pharmacy or
pharmaceutical chemistry of a recognized University, with at
least 5 years of experience in the testing of drugs in a
laboratory under the control of
a) Govt. Analyst
b) Head of an institution or approved testing laboratory
 A Postgraduate in medicine or science or pharmacy or
pharmaceutical chemistry of a recognized University, with at
least 3 years of experience in the testing of drugs in a
laboratory under the control of
a) Govt. Analyst
b) Head of an institution or approved testing laboratory
 Associate ship diploma of the Institution of Chemist, India, with
“Analysis of drugs & Pharmaceuticals” as one of the subject
with not less than 3 years of experience, in the testing of drugs
in a laboratory under the control of as mentioned in 1&2.

Duties of Government Analyst:
 To cause analysis or testing of samples of drugs / cosmetics sent
to him by Drug Inspectors or other persons under the provisions
of the Act for mfg/sale/distribution and furnish reports as per
rules.
 To forward from time to time reports giving the results of
analysis work and research with a view to their publication at
the discretion of the Govt.

Pharmacopoeial drugs Reference to specific test
and source
Patent or proprietary medicines for which
pharmacopoeial tests are applied
Reference to specific test
and source
Patent or proprietary medicines containing
pharmacopoeial drugs for which analytical
method is modified
Complete description of
tests or analytical
method used
Patent or proprietory medicines for which no
pharmacopoeial methods are applicable but
methods in std books and journals are
followed
tests +
Reference to specific test
and source
Drugs for which no methods are available but
have been evolved by the Govt. Analyst
the tests applied
Procedure to be followed on receipt of sample

Drug Inspector:
Means
 In relation to a Ayurvedic, Siddha or Unani drug, an
Inspector appointed by the Central Government or a
State Government under section 33G; and
 In relation to any other drug or cosmetics, an Inspector
appointed by the Central Government or a State
Government under section 21

1) A graduate in pharmacy or pharmaceutical sciences or medicine with
specialization in Clinical Pharmacology or Microbiology of a recognized
university;
Provided that for the purpose of Inspection of Manufacture of
substances specified in Schedule C, a person appointed as a Drug
Inspector should have,
(i) Not less than 18 months experience in the manufacture of atleast one
of the substances specified in Schedule C; or
(ii) Not less than 18 months experience in testing of atleast one of the
substances specified in Schedule C in a approved laboratory; or
(iii) Not less than 3 years experience in the inspection of firms
manufacturing any of the substances specified in Schedule C during the
course of their services as the Drug Inspectors
Qualifications for Drug Inspectors

Within the local limits for which the inspector is appointed, he may
i)Inspect:
a)Any premises wherein any drug or cosmetic is being manufactured. And
also he may inspect the means employed for standardizing and testing the
drug or cosmetic
b) Any premises wherein any drug or cosmetic is being sold or stocked or
exhibited or offered for sale or distributed
ii) Take samples of any drug or cosmetic:
a)which is being manufactured or being sold or is stocked or offered for
sale or exhibited or being distributed
b)from any person conveying, delivering or preparing to deliver any drug
or cosmetic to a purchaser or a consignee
Powers Of Drug Inspectors

iii) Search any person in connection with the offence under this chapter at all
reasonable times
(iv) Enter and search at all reasonable times, any place or premises in which he
has reason to believe that an offence is being committed or has been
committed
(v) Stop and search any vehicle or conveyance which he has reason to believe,
used for carrying any drug or cosmetic in respect of which offence has been
or is being committed
(vi) Give order in writing to the person in possession of drug or cosmetic in
respect of which offence has been committed not to dispose stock of such
drug or cosmetic for a specified period not exceeding twenty days or unless
the defect may be removed by the possessor of the drug or cosmetic, and
may seize the stock of such drug or cosmetic or any substance /article
employed for commission of offence

(vii) Examine any record, register, document, or any other material
object found while exercising above powers and seize the same if he
has reason to believe that it is an evidence of commission of an
offence under the Act
(viii) Exercise any other powers as may be necessary, for carrying out the
purpose of this Act and the rules made thereunder

In relation to sale of drugs and cosmetics:
(a) To inspect atleast once a year all establishments licensed for sale of
drugs in the area assigned to him and to satisfy himself whether the
conditions of the licences are observed or not
(b) If he thinks necessary to obtain and send samples of imported drugs
and cosmetics for test or analysis, which are being sold or stocked in
contravention of the provisions of this Act
(c) To investigate any complaint made in writing to him
(d) To institute prosecutions in case of the breach of the Act and Rules
(e) To maintain the records relating to all inspections and actions taken
by him and to submit copies of such records to the controlling authority
(f) To make inquiries and inspections regarding the sale of drugs in
contravention of the Act
(g) To detain the imported packages, if he suspects to contain drugs the
import of which is prohibited
Duties of Drug Inspectors

In relation to manufacture of drugs and cosmetics:
(a)To inspect atleast once a year all premises licensed for manufacture of drugs in
the area assigned to him and to satisfy himself whether the conditions of the
licences and provisions of the Act and Rules are observed or not
(b) To inspect premises licensed for mfg of drugs specified in Schedule C and C(1)
and to observe process of manufacture, means employed for standardization and
testing of drugs, storage conditions, qualifications of technical staff employed and
all other details of construction, location, administration of establishment etc.
which are likely to affect potency or purity of product.
(c) To send after each inspection, a detailed report of inspection to controlling
authority with details of conditions of licence and provisions of the Act and Rules
being observed and those not observed.
(d) To take samples of drugs manufactured on premises and send them for test
or analysis
(e) To check all records and registers required to be maintained under rules.
(f) To institute prosecutions for breaches of Act
Duties of Drug Inspectors

For taking samples of drug and dispatching them to laboratory :
1. Where an Inspector takes any sample of a drug or cosmetic, he shall tender the
fair price thereof and may require a written acknowledgment thereof.
2. Where the price is refused, he shall tender a receipt thereof in the
prescribed form.
3. Where an Inspector takes a sample of a drug or cosmetic for the purpose
of test or analysis, he shall intimate such purpose in writing in the prescribed form
to the person from whom he takes it and, in the presence of such person unless he
wilfully absents himself, shall divide the sample into four portions and effectively
seal and suitably mark the same and permit such person to add his own seal and
mark to all or any of the portions so sealed and marked.
4. Where the sample is taken from premises whereon the drug or cosmetic
is being manufactured, it shall be necessary to divide the sample into three
portions only
Procedure Of Inspectors

5. Where the drug or cosmetic is made up in containers of small volume, instead
of dividing a sample as aforesaid, the Inspector may, and if the drug or
cosmetic be such that it is likely to deteriorate or be otherwise damaged by
exposure shall, take three or four, as the case may be, of the said containers
after suitably marking the same and, where necessary, sealing them.
6. The Inspector shall restore one portion of a sample so divided or one
container, as the case may be, to the person from whom he takes it, and shall
retain the remainder and dispose of the same as follows:—
(i) one portion or container he shall forthwith send to the Government Analyst
for test or analysis;
(ii) the second he shall produce to the Court before which proceedings, if any,
are instituted in respect of the drug or cosmetic;
(iii) the third, where taken, he shall send to the person, if any, whose name,
address and other particulars have been disclosed as manufacturer or his
agent

For seizure of stocks:
 Whenever inspector suspects contravention he may seize any
stock of such drug or records, registers, documents which are
believed to be evidence of commission of offence, he should at
the earliest inform a judicial magistrate and take his order for
custody.
 Or He may order not to dispose off stock in prescribed format
(form 15)
 If he takes above action.he should Use all means to ascertain if
there is contravention, if not return stock
 If defect can be remedied, allow to do so and after satisfaction,
revoke order

 All inspectors at central and state level are under their control.
 Qualifications :
1. He is a graduate in Pharmacy / Pharmaceutical chemistry /
Medicine with specialization in Clinical pharmacology or
Microbiology from a University established in India
2. He has experience in mfg or testing of drugs or enforcement
of the provisions of the Act for a minimum period of 5 yrs.
(The requirement of academic qualification is not applicable to
inspectors and Government Analysts appointed before 12th
Apr
1989.
Controlling Authority

 State Govt.: Each State Govt. employs Licensing Authority to issue
license for manufacture, sale, distribution of drugs / cosmetics
within the state. They can Issue / refuse license/Cancel or suspend
license
 Central Govt. appoints licensing authority to issue license for
import of drugs
 DRUGS CONTROLLER OF INDIA IS CENTRAL LICENSE APPROVING
AUTHORITY
Licensing Authority

Qualifications:
1. He is a graduate in Pharmacy / Pharmaceutical chemistry /
Medicine with specialization in Clinical pharmacology or
Microbiology from a University established in India
2. He has experience in manufacturing or testing of drugs or
enforcement of the provisions of the Act for a minimum period
of 5 yrs.
The requirement of academic qualification is not applicable to
inspectors and Government Analysts appointed before 12th
Apr
1989.
Licensing Authority

 The customs collectors or person on his behalf may detain
imported package which he suspects to contain drug / cosmetic
import of which is prohibited, report detention to Drugs
Controller and if required forward sample to CDL
 Laws relating to Sea Customs Act are applicable.
Customs Collectors

Import of Drugs
 Import means to bring into India

Classes of drugs prohibited to Import
 Any drug which is not of standard quality.
 Any misbranded, spurious or adulterated drug
 Any misbranded or spurious cosmetic
 Any drug or cosmetics which require import license & if imported
without such license.
 Any patent or proprietary medicine, the true formula or list of
active ingredients with their true quantities, is not displayed on
the label or container in a prescribed manner.
 Any cosmetics containing any such ingredient which may render
it unsafe or harmful for use.
 Any drug which claim to cure or prevent any disease or ailment
described in schedule J.
 Any drug or cosmetic the import of which is prohibited by rules.

Import of drug & cosmetics permitted
under license only
 Drugs specified in schedule C & C1
 Drugs specified in schedule X
 Drugs for examination, test or analysis.
 Drugs for personal use
 Any new drug

Import of schedule C & C1 drugs
The license for the import of schedule C & C1 drug is
granted subject to the following condition.
 Licensee must have adequate facilities for the storage
of imported drugs so that the properties of drugs are
preserved.
 Licensee must maintain the records of sale of drugs
showing particulars of the names of the drugs & of the
persons to whom they have been sold.
 Licensee must allow the inspector to inspect the
premises where imported drugs are stored & to check
the record & to take the samples for test or analysis.
 Licensee on request, shall supply the samples of drugs
from all batches to the licensing authority for test or
analysis.

 Licensee must not sell the drugs from any batch from
which samples have been supplied to the licensing
authority, except under the advise of the licensing
authority.
 The licensee must comply with the undertaking given
in form 9.
 The import license may be cancelled or suspended, if
conditions are not satisfied.

Import of schedule X drugs
The license for the import of schedule X drug is granted
subject to the following condition.
 Licensee must have adequate facilities for the storage
of imported drugs, so that the properties of drugs are
preserved.
 Licensing authority may also refuse to grant the
license if the license granted to the applicant
previously was suspended or cancelled. Or in case if
the applicant failed to comply with any provision of
the act ie drug & cosmetics act or NDPS
 However if the applicant is not satisfied with the
decision may appeal to central government within 30
days.

Import of small quantities of drug for
examination, test or analysis
 Small quantities of drugs, the import of which is prohibited under
the act may be imported for the purpose of examination, test or
analysis, subject to the following conditions.
 The licensee must use imported drug exclusively for the purpose
for which they are imported & specified in the license.
 Licensee must maintain the records of imported drugs, showing
particulars of their quantities, names of manufacturer & date of
import.
 Licensee must allow the inspector to inspect the premises where
imported drugs are kept & to check the record & to take the
samples for test or analysis.
 Licensee must comply with other conditions as prescribed.

Import of drugs for personal use
 Small quantities of drugs, the import of which is otherwise
prohibited may be imported for personal use without any
license subject to the following conditions.
 The drug shall form the passenger’s bonafide luggage & shall
exclusively be for personal use of the passenger.
 The drug shall be declared to the customs authority, if they
direct so.
 The quantity of any single drug so imported shall not exceed
100 doses.
 The licensing authority may in an exceptional case, sanction the
import of large quantity. Drug is not forming a part of bonafide
personal luggage if
 The drug is for bonafide personal use.
 The quantity to be imported is reasonable & is covered by
prescription of RMP.

Import of new drug
 No new drugs are allowed to imported without the
sanction of the licensing authority.
 The importer of new drug when applying for
permission, shall produce all documentary evidence
& other evidences relating to its standards,
standards of quality & purity, strength, and such
other information including the clinical trials; to the
licensing authority.

Import of drug without license or permit
 Drugs other than those discussed above, may be
imported without any permit or license.
 However before such drugs are imported into the
country, the importer should submit a declaration to
the custom collector that they comply with all the
provisions of chapter III of D&C Act.

Places through which the drugs are imported
 The import of drug in India is allowed only through
following places.
 By Sea: Mumbai, Chennai, Kolkata, Cochin,
Vishakhapattanam & Nhava sheva
 By Air: Delhi, Mumbai, Chennai, Kolkatta, Ahmedabad
& Hyderabad
 By Rail:
 Ferozpure cantt & Amritsar Rly station (for drugs coming
from pakistan)
 Ranaghat, Bongaon & Mahiassan (for drugs coming from
Bangladesh)
 Raxaul (for drugs coming from Nepal)

Drugs exempted from provisions
regulating imports of drug
 Substances not intended for medical use. (condition:
label should bear that not for medicinal use.)
 Following substance which are used both as article of
foods & drugs. (Condition: Exempted from all
provisions of chapter III)
 All condensed or powdered milk.
 Farex, oats, lactose, cerelac except for parenteral use.
 Virol, Bovril, Chicken essence & other similar
predigested food.
 Cinnamon, pepper, zinger & other condiment & spices.

Offences & Penalty related to import of
drug
 Any one who,
1. Imports adulterated or spurious drug or cosmetic or
cosmetic unsafe for use
 Punishable with imprisonment upto 3 years or with fine
upto 5,000 or both on first conviction
 & punishable with imprisonment upto 5 years or with
fine upto 10,000 or both on subsequent conviction

2. Imports any drug or cosmetic the import of which is
prohibited under section 10.
 Punishable with imprisonment upto six months or with fine
upto 500 or both on first conviction
 & punishable with imprisonment upto 1 year or with fine upto
1,000 or both on subsequent conviction
3. Imports any drug or cosmetics, the import of which is
prohibited in the public interest.
 Punishable with imprisonment upto 3 years or with fine upto
5,000 or both on first conviction
 & punishable with imprisonment upto 5 years or with fine
upto 10,000 or both on subsequent conviction

Manufacture of drugs
 Definition
 Manufacture in relation to any drug or cosmetics
includes any process or part of process for making,
altering, ornamenting, finishing, packing, labeling,
breaking up or otherwise treating or adopting any
drug or cosmetic for sale or distribution but does not
include compounding or dispensing of any drug or
the packing of any drug or cosmetic in the ordinary
course of retail business.

Kinds of manufacturing licenses
 License for manufacture of schedule C & C1 drugs
 License for manufacture of schedule X drugs
 License for manufacture of drugs other than those
specified in schedule C & C1, X.
 License for manufacture of drugs meant for
examination, test or analysis.
 Loan license
 Repacking license

Manufacture of biological & other special
products specified in schedule C&C1
A person licensed to manufacture schedule C & C1 drugs, is
required to observe the following conditions (General
Condition)
 Licensed premises must conform to the requirements of GMP
specified in schedule M.
 The licensee must provide adequate arrangement for testing
the strength & quality of drugs.

 The manufacture of drugs must be carried out under active
direction & personal supervision of technically qualified staff
(who should be either
 a) graduate in pharmacy or pharmaceutical chemistry with at least 18
months experience in the manufacture of drugs or
 b) a graduate in medicine with at least 3 years experience in the
manufacture & testing of drugs or
 c) Graduate in science with chemistry or microbiology as the principal
subject or graduate in chemical engineering with at least 3 years
experience in the manufacture & testing of drugs or
 d) Any other equivalent foreign qualification.
 Licensee must have adequate facilities for the storage of
imported drugs, so that the properties of drugs are preserved.

 Licensee must maintain the manufacturing & analytical records
of the drugs (records should be preserved for at lest 2 years
after the expiry of date for drugs with expiry & 5 years from
the date of manufacture for other drugs.)
 Licensee must allow the inspector to inspect the premises
where imported drugs are kept & to check the record & to take
the samples for test or analysis.
 Licensee must inform to the licensing authority about any
changes in the technical staff or any material changes in the
plant or premises since the date of last inspection.
 Licensee on request, shall supply the samples of drugs from all
the batches to the licensing authority for test or analysis.

 The following special provision related to biological or other
special product must comply.
 All schedule C drugs must be issued in a previously sterilized
glass containers sealed so as to prevent entry of bacteria.
 Drugs must comply with the standards of strength, quality &
purity as specified in schedule F.
 Biological products such as sera, vaccine, antigen, antitoxin,
insulin etc. should be tested for the absence of living &
anaerobic microorganism.
 The test for sterility must be carried out.

Manufacture of drugs specified in schedule X
In addition to general conditions as mentioned before the
licensee should observe the following conditions.
Accounts of all transactions relating to the manufacture should
be maintained in a serially bound & paged register.
Drugs should be stored in bulk & if needed for manufacture
outside storage place they should be kept in a separate place in
the custody of responsible person.
Licensee must submit a report to the licensing authority every
3 months regarding manufacture & sale of drugs.
No schedule X drugs should be supplied by way of physician
sample.

Manufacture of drugs other than those
specified in schedule C,C1 & X
In addition to general conditions as mentioned before the
licensee should observe the following conditions.
The licensee should maintain an inspection book in which the
inspector may record their inferences.
If the licensee desires to undertake the manufacture of any
additional categories of drugs he should pay a fee of Rs. 10 for
each such additional category.
Licensee must comply with such additional requirements of
which he has been given at least 4 months notice by the
licensing authority.

Manufacture of drugs for examination, test
or analysis
The following conditions must be observed by the licensee.
Licensee must use manufactured drug exclusively for the
purpose for which they are manufactured.
Licensee must maintain the records of the manufactured
drugs, showing particular of their quantities & names of the
persons to whom they have been supplied.
Licensee must allow the inspector to inspect the premises
where drugs are kept & to check the record & to take the
Licensee must comply with such additional requirements of
which he has been given at least 1 month notice by the licensing
authority.

Loan License
 It means a license issued by the licensing authority to
a applicant who does not have his own
arrangements for manufacture but who intends to
avail himself of the manufacturing facilities owned by
another licensee.

 Application for grant of loan license should be supported by
documentary consent of the licensee whose facilities he is going
to use.
 Before granting a license the authority may satisfy himself that
the person, whose facilities applicant wishes to use must possess
necessary staff, equipment & space for manufacture of drugs.
 The loan license shall be deemed to be cancelled or suspended, if
the license owned by licensee whose manufacturing facilities
have been availed by the licensee is cancelled or suspended.
 The licensee must test each batch of raw material & finished
product.
 Licensee should maintain manufacturing & analytical records of
drugs.
 Licensee must allow the inspector to inspect the premises where
drugs are kept & to check the record & to take the samples for
test or analysis.

Repacking License
 It means the process of breaking up any drug from a
bulk container into small packages & the labeling of
such package with a view to its sale & distribution,
but does not include the compounding or dispensing
or the packing of any drug in the ordinary course of
retail business.

Person licensed to repack drug should observe the following
condition.
Licensed premises must conform to the requirements of GMP
specified in schedule M.
Licensee must provide adequate arrangements for testing the
strength & quality of drugs.
The manufacture of drugs must be carried out under active
direction & personal supervision of competent person.
 a) person who either holds diploma in pharmacy or Registered pharmacist
under pharmacy act.OR
 b) Have passed the intermediate examination with chemistry as principal
subject.OR
 c) Have passed matriculation examination & have not less than 4 years of
experience in manufacturing or dispensing or repacking of drugs.
Licensee must have adequate facilities for the storage of drugs, so
that the properties of drugs are preserved.

 Licensee must maintain the records for the repacking of drugs.
 Licensee must allow the inspector to inspect the premises
where drugs are repacked & to check the records & to take the
changes in the technical staff or any material changes in the
plant or premises since the date of last inspection.
 Licensee on request, shall supply the samples of drugs from all
the batches to the licensing authority for test or analysis.
 In addition to other particulars, the repacked drug should bear
the no. of license with words “Rpg. Lic. No.” on its label.
 The license should be kept on the licensed premises & should
produce before an inspector on demand.
 Licensee should comply with the provisions of the act.

0fenses & Penalties for manufacture of drugs
1. Manufacture of drug/ adulterated drug/ spurious drug likely to
cause death or grievous body hurt as per sec. 320 of IPC.
 5 years----life imprisonment & not less than Rs. 10,000 fine.
2.Manufacture drugs without license or adulterated drug not likely
to cause death or grievous body hurt
 1-3 years imprisonment & not less than Rs. 5,000 fine.
3.Manufacture of drug in contravention of any other provision.
 1-2 years imprisonment & with fine.
4. Failure to keep records or disclose required information
 1 year imprisonment & or fine Rs. 1,000
5.False warranty by manufacturer to a purchaser
 imprisonment or fine upto Rs. 500 or both.
6.Use of Govt. analyst report for advertising
 Fine upto Rs.500

Sale of Drugs
 Sale may be defined as the process of passage of articles from
the manufacturer to the consumer.
 There are two general types of sale
 Retail sale
 Wholesale
 Retail Sale: It means a sale whether to a hospital or a
dispensary or medical, educational, or research institute or to
any other person other than a sale by way of wholesale
dealing.
 Wholesale: (sale by way of wholesale dealing) It means a sale
to a person for the purpose of selling again & also includes a
sale to hospital or a dispensary or medical, educational, or
research institute

 Drug store: It means a licensed premises for the sale of drug
who do not require the services of a qualified person.
 Chemist & druggist: It means a licensed premises for the sale
of drug who requires the services of a qualified person but
where the drugs are not compounded against prescription.
 Pharmacy: It means a licensed premises for the sale of drug
who requires the services of a qualified person but where the
drugs are compounded against prescription.

Form no. in which licenses are issued for the sale,
stock, exhibit for sale or distribution of drugs
License
issued
Form No.
Drugs other
than Sch.C,C1
& X
Sch. C&C1
drugs
Sch.X drugs
Retail 20 21 20-F
Restricted 20-A 21-A -
Wholesale 20-B 21-B 20-G
Wholesale or
distribution from
motor vehicle
20-BB 21-BB -

Kinds of licenses for wholesale
Wholesale
From Shop
From motor
Vehicle
License for
wholesale
Of C&C1
License for
Drugs other
Than Sch C&C1
License for
C&C1 drugs
License for
Drugs other
Than Sch C&C1

Kinds of licenses for Retail sale
Retail
From Shop vendors
Drug store
Chemist &
druggist
Only specified
Drugs in
specified
area
pharmacy

Wholesale of schedule C&C1 drugs
 Following conditions are to be satisfied by the licensee having wholesale of
schedule C&C1 drugs
 The license should be displaced in a prominent part of premises opened to the
public.
 The licensee must have adequate premises which should not be less than 10
sq. meters, equipped with facilities for the proper storage of drugs.
 Licensee should maintain records related to all purchase & sale of drugs, with
particular such as
a) date of purchase & sale
b) name & addresses of the person from whom purchased &
to whom sold.
c) names & quantities of drugs & their batch no.
d) names of manufacturers of drugs
 Drug should be purchased from dully signed manufacturer.
 Drug should be sold only to those persons who are licensed to retail them.
 The licensee should comply with all the provisions as per the act.

Wholesale of drugs other than those
specified in schedule C&C1
 Drugs should not be sold to any person
who do not hold the license for the retail
sale or distribution of drugs of these class.
 The general conditions as mentioned in
previous slide

Wholesale from motor vehicle
 The general conditions as mentioned in
previous slide
 Separate license is necessary for
schedule C&C1 drugs & other than those
specified in schedule C&C1
 The license should be displaced in the
prominent place in the vehicle.
 Drugs may also be distributed to govt.
hospital or institutions.

Retail sale from shops
 Facilities as per schedule N.
 Purchased only from licensed wholesalers.
 No sale of specified drugs
 Separate license for sch. C,C1 & X drugs.
 Sale under qualified supervision.
 Records
 Inspection
 Sale of specified households drugs from drug
stores.

Licenses for chemist & druggist shops &
pharmacy
 The license granted subject to the following conditions.
 The licensee must have adequate premises & facilities for
proper storage of drugs & under the supervision of competent
person for sale & distribution of drugs.
 Must fulfill the requirements as per sch. N.
 Must obtain the permission to sale additional categories of
drugs.
 Licensee must maintain records of drugs.
 Licensee must allow an inspector to inspect the premises & to
check the records.
change in qualified staff.
 Precaution must be taken during storage of sch C & C1 drugs.

Sale of sch X & sch X drugs
 Drugs specified in schedule H & X should be sold only on prescription of RMP.
 In case of sch. X drugs, the prescription should be in duplicate & should be
retained for 2 years.
 The cash or credit bill should bear a signature of customer with his address.
 Separate bound & paged registers should be maintained for supply in which
separate sheets should be allotted for each drug.
 The following particulars should be enter at the time of supply
a) date of supply
b) opening & closing stocks of drugs on that day & relevant bill
number.
c) name of the drug, its manufacturers name & batch no.
d) name & address of the purchaser
e) date of prescription & name & address of RMP
f) signature of Registered pharmacist under whose supervision supply is made.
 Supply of drugs to medical practioner & other institution should be preserve
for at least 3 years from the date of supply.

 General license: general license is granted to a
person who have premises for business & who have
engage the services of qualified person to supervise
the sale of drug & do the compounding & dispensing.
 Restricted license: restricted license is granted to
those dealer who do not engage the services of
qualified person.

Classes of drugs prohibited for wholesale
 Misbranded, spurious & adulterated drugs & drugs not of
standard quality
 Any patent or proprietary medicine
 Any drug which claims to cure or prevent any disease or
ailments as described in sch J.
 Any drug manufactured or imported in contravention to the
act.
 Drugs whose date of expiry has expired.
 Drugs intended for supply to central govt. health scheme or
govt hospital or institution.
 Physician samples.
 Drugs not intended for sale.

Offenses & penalty for sale of drugs
Sale, stocking, exhibition or offer for sale of drugs likely to cause
death or grievous hurt as per sec. 320
 5 years----life imprisonment & not less than Rs. 10,000 fine.
Sale, stocking, exhibition or offer for sale of adulterated drug
 1-3 years imprisonment & not less than Rs. 5,000 fine on first
conviction & 2-6years imprisonment & not less than Rs. 10,000
fine on subsequent conviction
Sale, stocking, exhibition or offer for sale of spurious drugs
 3-5 years imprisonment & not less than Rs. 5,000 fine on first
conviction & 6-10 years imprisonment & not less than Rs. 10,000
fine on subsequent conviction

Sale of drug in contravention of any other provision
 1-2 years imprisonment & fine on first conviction & 2-4 years
imprisonment & not less than Rs. 5,000 fine on subsequent
conviction
Failure to keep records or disclosed required information
 Imprisonment upto 1 year & or fine upto Rs. 1000
False warranty to purchaser
 Imprisonment upto 1 year & or fine upto Rs. 5000 on first
conviction & 2 years imprisonment or fine or both on
subsequent conviction.
Use of govt. analyst report or CDL report for advertising
 Fine upto Rs.500 on first conviction & imprisonment upto 10
years or fine or both on subsequent conviction.

Labeling & Packing of drug as per D&C Act
1940
Legal requirements for labeling of drugs are as follows
Name of drug (official name, trade name)
Name of manufacturer & his address along with license
no. & batch no.
Potency, standard, grade, dose etc expressed as ML,
grains, units etc.
Net contents by volume/weight/number
Manufacturing & expiry dates (schedule P & C drugs only)
Precautions for handling, storage, sale or usage etc.
Special instructions may be there such as for veterinary
use, physician sample etc.
Special labeling for, “drug for export”, “dispensed drug”.

For schedule G drugs
 “Caution: It is dangerous to take this preparation except
under the medical supervision”.
For schedule H drugs
 Warning: To be sold by retail on the prescription of a
registered medical practitioner only”.
 Symbol Rx prominently on left hand top corner of the label.
 Symbol NRx prominently on left hand top corner for
narcotic & psychotropic substances.

Schedule X drugs
 “schedule X drug Warning: To be sold on prescription of
RMP only.
 Symbol XRx in red on left hand top corner.
Ophthalmic
solution/suspension/ointment
 Use within one month after opening the container.
 FOR OPTHALMIC USE ONLY
 NOT FOR INJECTION
 Name & concentration of
preservatives if used.
 Special instructions regarding storage
wherever applicable.
 Warning: If irritation persist or increases, discontinue the
use & consult the physician.
 Do not touch the dropper tip or other dispensing tip to any
surface since this may contaminate the solutions.

Veterinary drugs
 Not for human use
 For animal treatment only
 Head of any domestic animal
Packing of drugs specified in Sch X
 The drugs specified in sch. X can be marketed
in packing not exceeding
i) 100 unit doses in case of tablet/capsules
ii) 300 ml in case of liquid preparation
iii) 5 ml in case of injection.

 For 10 ml
vial of insulin
80 units/c.c.
Rx INSULINRx INSULIN
80 units/c.c.80 units/c.c.
Mfg lic no.A-320Mfg lic no.A-320
Batch No. B-111Batch No. B-111
Mfg date: April 2009Mfg date: April 2009
Schedule G drugSchedule G drug
Caution: It is dangerous to take thisCaution: It is dangerous to take this
preparation except under medicalpreparation except under medical
supervision onlysupervision only
SaeE Pharmaceuticals Ltd.SaeE Pharmaceuticals Ltd.
D-99 MIDC, Butibori, NagpurD-99 MIDC, Butibori, Nagpur

Labeling of cosmetics
1. On both inner & outer label it should indicate
 Name of the cosmetic
 The name & address of the manufacturer
2. On the outer label, it should indicate the net content of the
package. Such statement need not appear on the label if
the net content does not exceeds 60 ml/30 grams
3. On the inner label, it should indicate, the proper direction
of safe use, warning, caution, or the ‘special direction’ &
the names & contents of ingredients that are poisons or
hazardous.
4. The label in addition should indicate
 batch no., only if the content of cosmetics is more than 10 gms or 25 ml, in
case of soap instead of batch no. the month & year of manufacture of soap
shall be given on the label.
 Mfg lic no. Preceded by letter M.
5. If the package or container of the cosmetic has only one
label, it should contain all the information required to be
shown on both inner & outer label.

Labeling of hair dyes
 Hair dyes containing coal tar color should
label (inner & outer)
 “Caution: This product contains
ingredients which may cause skin irritation
in certain cases & so a preliminary test
according to directions should first be
made . The product should not be used for
dyeing eye lashes or eye brows, as such
as use may cause blindeness.

Labeling of toothpaste containing
fluorides
 Fluoride content in tooth paste shall not be
more than 1000 ppm & the content of fluoride
in terms of ppm shall be mentioned on tube &
carton
 Date of expiry shall be mentioned on tube &
carton

Drug and cosmetic act 1940

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Drug and cosmetic act 1940