Objectives, Definitions, Legal Definitions of Schedules to the act and rules Part 1 5th Semester B.Pharm Pharmaceutical Jurisprudence

1. DRUGS AND COSMETICS ACT,
1940 AND RULES, 1945
PART - I
L1 Objectives, Definitions, Legal definitions of
schedules to the act and rules
Nabeela Moosakutty
Lecturer
Dept. of Pharmaceutics
K.T.N College of Pharmacy

2. Drugs and Cosmetics Act
 Passed on10th April 1940 by the Indian Legislature
 To control the import, manufacture, distribution and sale of drugs and cosmetics
 Amendment
1955 by the Indian Parliament
Subsequently amended in 1960,1962, 1964, 1972, 1982, 1986, 1995 and 2008
 The related Drugs and Cosmetics Rules, 1945 contains provisions for classification of
drugs under given schedules and there are guidelines for the storage, sale,
display and prescription of each schedule
Objective:
Act to control or regulate the import, manufacture, distribution and sale of drugs and
cosmetics
Definitions:
1.Ayurvedic, Siddha or Unani Drug
It includes all medicines intended for internal or external use or in diagnosis, treatment,
prevention, mitigation or cure of diseases 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 medicines specified in
First Schedule

3. 2. Cosmetic
It means any article intended to be rubbed, sprayed, poured, sprinkled on or
introduced into or otherwise applied to the human body thereof, for cleansing,
beautifying or promoting the attractiveness or altering the appearance and also
includes any article intended to be used as a component of cosmetic but does not
include soap
3. Government Analyst
It means
1. In relation to any drug or cosmetic, Government Analyst appointed by Central
Government or State Government under section 20 or
2. In relation to Ayurvedic, Siddha or Unani system of Medicine, Government
Analyst appointed by Central Government or State Government under section
33 F
4. Drug Inspector
1. In relation to any drug or cosmetic, Drug Inspector appointed by Central
Government or State Government under section 21 or
2. In relation to Ayurvedic, Siddha or Unani systems of Medicine, Drug Inspector
appointed by Central Government or State Government under section 33G

4. 5. Manufacture
Manufacture in relation to any drug or cosmetic includes any process or part of
process for making, altering, ornamenting, finishing, packing, labeling, treating or
adopting any drug or cosmetic with a view to its sale or distribution but does not
include compounding or dispensing of drugs in the ordinary course or the course of
retail business
6. Drug
It means
1. All medicines for internal or external use of human beings or animals and all
substances intended to be used for or in diagnosis, treatment, prevention,
mitigation or cure of diseases in human beings or animals including preparations
applied on human body for the purpose of repelling insects like mosquitoes or
2. Substances other than food intended to affect or alter the structure or any organic
functions of the body of human beings or animals or intended to be used for
destruction of vermins (like fleas, lice) which may cause diseases in human beings
or animals or
3. Any article intended to be used as a component of drug including empty gelatin
capsules or
4. Devices intended to be used for or in diagnosis, treatment, mitigation, prevention
or cure of diseases in human beings or animals

5. 7. Patent and Proprietary Medicine
It means
1. In relation to, Ayurvedic, Siddha or Unani systems of medicine, all the
formulations containing only such ingredients mentioned in the formulae
described in authoritative books of Ayurvedic, Siddha or Unani systems as
specified in First Schedule but does not include medicine which is administered
by parenteral route and also formulation which is included in authoritative
books as specified in First schedule
2. In relation to drug, drug which is a remedy or prescription prepared for internal
or external use of human beings or animals and which is not included in any
edition of Indian Pharmacopoeia or any other Pharmacopoeia authorized by
Central Government in this behalf after consultation with Drugs Technical
Advisory Board
8. Standards of Quality
It means
a) In relation to drug that drug complies with the standards as specified in the
Second Schedule
b) In relation to cosmetic that cosmetic complies with the standards as may be
prescribed

6. 9. Qualified Person
It means a person
a) who holds degree or diploma in Pharmacy or Pharmaceutical Chemistry; or
b) who is registered pharmacist; or
c) who has minimum four years experience in dispensing and compounding of drugs
and has been approved as “Qualified Person” on or before 31st December 1969
10. Drug Store
It is a licensed premise for the sale of drug which do not require the services of
Qualified Person and where drugs are not compounded against prescription
11. Chemists and Druggists
It is a licensed premise for the sale of drug which requires services of Qualified
Person but where drugs are not compounded against prescription
12. Pharmacy
It is a licensed premise for the sale of drug which requires the services of “Qualified
Person” and where drugs are compounded against prescription

7. 13. Sale by the way of wholesale dealing
It means sale to a person for the purpose of selling again and also includes sale to
medical, hospital, dispensary, educational or research institutions
14. Retail Sale
It means sale other than sale by the way of wholesale dealing
15. Repacking of Drug
It is the process of breaking up any drug from the bulk container into small packages
and labeling of each package with a view to its sale and distribution but does not
include compounding and dispensing of drug in the ordinary course or the course of
retail business
16. Loan License
It means a license granted to a person who do not have his own arrangements of
manufacture but who intends to avail himself of the manufacturing facilities owned
by another manufacturer
17. Registered Homoeopathic Medical Practitioner
It means a person who is registered in the Central Register or State Register of
Homoeopathy

8. 18. Adulterated Drugs
A drug shall be deemed to be adulterated if
a) It contains in whole or in parts of filthy, putrid or decomposed substances; or
b) It is prepared, packed or stored under unsanitary conditions whereby it may have
been contaminated with filth or which may render the contents injurious to the
health, or
c) Its container is composed in whole or in parts of poisonous or deleterious
substance which may render the contents injurious to the health; or
d) It contains or bears for the purpose of coloring only, a color other than those
prescribed or
e) It contains harmful or toxic substances which may render it injurious to health; or
f) Any substance has been mixed therewith so as to reduce its quality or strength
19. Misbranded Drugs
A drug shall be deemed to be misbranded if
a) It is so colored, coated, powdered or polished that the damage is concealed or if
it is made to appear of better or greater therapeutic value than it really is; or
b) It is not labeled in the prescribed manner; or
c) Its label or container or anything accompanying drug bears any statement, design
or devices which makes any false claim for drug or which is false or misleading in
any particular

9. 20. Spurious Drug
A drug shall be deemed to be spurious
a) If it is imported under a name which belongs to another drug ;or
b) If it is an imitation of or is a substitute for another drug or resembles to another
drug in a manner likely to deceive or bear upon its label or container the name of
another drug unless it is plainly or conspicuously marked so as to reveal its true
character and its lack of identity with such other drugs; or
c) If its label or container bears the name of an individual or company purporting to
be product of manufacturer which individual or company is fictitious or does not
exists ; or
d) If it has been substituted wholly or in parts by another drug or substance; or
e) If it purports to be product of a manufacture of whom it is not truly a product
21. Misbranded Cosmetic
A cosmetic shall be deemed to be misbranded
a) If it contains color other than those prescribed ; or
b) If it is not labeled in the prescribed manner ; or
c) If its label or container or anything accompanying cosmetic bears any statement
which is false

10. 22. Adulterated cosmetic
(As per the Drugs and Cosmetics Amendment Act, 2008 as passed on 21 Oct
2008 )
A cosmetic shall be deemed to be adulterated,-
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 unsanitary 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 substances which may render the contents injurious to health;
or
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

11. 23. Spurious Cosmetic
A cosmetic shall be deemed to be spurious
a) If it is imported under a name which belongs to another cosmetic; or
b) If it is an imitation of or is a substitute for another cosmetic or resembles to
another cosmetic in a manner likely to deceive or bear 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
c) If its label or container bears the name of an individual or company purporting to
be manufacturer of cosmetic which individual or company is fictitious or does
not exits; or
d) If it purports to be the product of a manufacturer of whom it is not truly a
product
24. Homoeopathic Medicines
It means any drug which is recorded in Homoeopathic provings or therapeutic
efficacy of which has been established through long clinical experience as recorded
in Homeopathic literature of India and abroad and which is prepared according to
the techniques of Homoeopathic pharmacy and covers the combination of
ingredients of such Homoeopathic medicines
but does not include any medicine which is administered by parenteral route

12. 25. New Homoeopathic Medicine
It means
a) A Homoeopathic medicine which is not specified in Homoeopathic
Pharmacopoeia of India or United States of America or the United Kingdom or
German Homoeopathic Pharmacopoeia; or
b) which is not recognized in Homoeopathic literature as efficacious under the
conditions recommended; or
c) a combination of Homoeopathic medicines containing one or more medicine
which are not specified in any of the Pharmacopoeias referred above in (a) as
Homoeopathic medicine and also not recognized in authoritative Homoeopathic
literature as efficacious under the conditions recommended
26. New Drug
It means
a) a drug the composition of which is such that the drug is not generally recognized
among experts as safe for use under the conditions recommended or suggested
in the label thereof; and
b) includes any drug the composition of which is such that drug as result of
investigations for determining its safety for use under such conditions, is so
recognized but which has not, otherwise than during the course of such
investigation been used to enlarge, extent or for any appreciable length of time
under the said conditions

13. Schedules to the Act
First Schedule
It prescribes the list of books specified in Ayurvedic, Siddha or Unani systems of
medicine
Second Schedule
It prescribes the standards to be complied with by imported drugs and by the drugs
manufactured for sale, sold stocked or exhibited for sale or distributed.
Schedules to the Rules
Schedule A
It prescribes different forms required under Drugs and Cosmetic Act, for making the
application to grant or issue of licenses, sending memorandum, etc
Schedule B
It prescribes the fees to be charged for test or analysis of samples of drugs by Central
Drugs Laboratory and Government Analyst
Schedule C& C (i)
It prescribes the list of the biological and other special products

14. Schedule D
It prescribes classes of drugs which are exempted from the certain provisions
applicable to the import of drugs
Schedule E
It prescribes list of poisonous substances - omitted (22/6/1982)
Schedule E (i)
It prescribes list of Ayurvedic, Siddha and Unani poisonous substances
Schedule F
It prescribes provisions applicable to the blood bank requirements and licensing to
process the blood components
Schedule F(i)
It prescribes provisions applicable to the production of bacterial as well as viral
vaccines, sera and diagnostic antigens
Schedule F(ii)
It prescribes the standards for surgical dressings
Schedule F (iii)
It prescribes the standards for the umbilical tapes

15. Schedule FF
It prescribes the standards for ophthalmic preparations
Schedule G
It prescribes list of drugs which are required to be taken only under the supervision
of a Registered Medical Practitioner
It is labeled with direction: ‘Schedule G Drug’
Caution “It is dangerous to take this preparation except under the supervision of
Registered Medical Practitioner”
Schedule H
It prescribes list of drugs which are to be sold by retail only on the prescription of
Registered Medical Practitioner
Schedule H drugs are labeled with direction-
“To be sold by retail only on the prescription of Registered Medical Practitioner”
Schedule I
It prescribes calculation of proportion of poisons in certain cases -omitted
(22/6/1982)
Schedule J
It prescribes the list of ailments or diseases for which drugs may not claim to
prevent or cure

16. Schedule K
It prescribes classes of drugs which are exempted from certain provisions applicable
to manufacture of drug
Schedule L
It prescribes list of drugs to be sold on prescription only - omitted (22/6/1982)
Schedule M
It prescribes the good manufacturing practices (GMP) and the requirements of
factory premises, plant, equipments, etc for manufacture of drugs
Schedule M (i)
It prescribes requirements of factory premises, plant, equipments, etc for
manufacture of Homoeopathic drugs
Schedule M (ii)
It prescribes requirements of factory premises, plant, equipments, etc for
manufacture of cosmetics
Schedule M (iii)
It prescribes requirements of factory premises, plant, equipments etc for
manufacture of Medical devices

17. Schedule N
It prescribes minimum equipments to be possessed by pharmacy
Schedule O
It prescribes provisions applicable to the black disinfectant fluids
Schedule P
It prescribes life period of drugs
Schedule P(i)
It prescribes the pack sizes of drugs
Schedule Q
It prescribes the list of permitted coal tar colours for use in cosmetics and list of
permitted colours for use in soaps
Schedule R
It prescribes the standards for condoms made of rubber latex intended for single use
Schedule R (i)
It prescribes standards for medical devices
Schedule S
It prescribes standards for cosmetics

18. Schedule T
It prescribes the requirements of factory premises, plant, equipments and hygienic
conditions for manufacture of Ayurvedic, Siddha, and Unani Drugs
Schedule U
It prescribes the particulars to be shown in the manufacturing records of drugs
Schedule U (i)
It prescribes the particulars to be shown in the manufacturing records of cosmetics
Schedule V
It prescribes standards for patent and proprietary medicines
Schedule W
It prescribes the list of drugs which are marketed under generic name only
Schedule X
It prescribes list of habit forming narcotic drugs and psychotropic substances for the
import, manufacture, distribution and sale of which requires a license
Schedule Y
It prescribes requirements and guideline on clinical trials for the import and
manufacture of new drugs