All the schedules of Drugs & Cosmetics Act ,1940 as well the Rules,1945 are detailed described. Also the history, objectives, role, all the amendments & orders of the D & C Act are described in most simplified way.

1. SCHEDULES OF
DRUGS & COSMETICS
ACT (1940), RULES (1945)
1

2. Mr. Shaktiprasad Pradhan
M.Pharm, Ph.D*
Research Scholar & SRF-ICMR, UDPS
shakti.pharma16@gmail.com
Utkal University, Bhubaneswar
Odisha, India
2

3. DRUGS & COSMETICS ACT, 1940
History:
The modern medicines have been imported by India till after the
first word war which made India mostly dependent.
In August 1930, the Government of India, under the chairmanship
of R.N. Chopra appointed a Drug Enquiry Committee for the quality
& standard of drugs sold and recommendation for control measure.
In 1937, a bill was introduced to give effect to the
recommendations of the Drugs Enquiry Committee in the Central
Legislative Assembly for a more comprehensive measure for the
uniform control of import, manufacture, distribution and sale of
drugs was desirable.
In 1939, the Drug Import Bill was prepared & placed for
consideration before the Central Legislative Assembly.
In 10th April, 1940 the bill was passed & received assent of the
Governor General in Council & became the Drugs and Cosmetics Act.
In 1945, the related Drugs Rules were passed & since 1940, a
number of amendments have been done in the Act and is currently
known as the Drugs and Cosmetics Act, 1940. 3

4. Objectives of D & C Act, 1940
The Act visualizes the regulatory control over the drugs
imported in to the country by the Central Government while the
manufacture, sale and distribution of drugs is primarily
regulated by the State Drug Control Authorities appointed by
the respective State Governments.
The primary objective of the Act is to ensure that the drugs &
cosmetics sold in India are safe, effective and conform to state
quality standards and to make available Standard Quality drug/
cosmetic to consumer.
The manufacture and sale of the drugs is regulated through a
system of licensing and inspection by the Licensing Authorities.
The Central Drugs Standard Control Organization (CDSCO),
headed by the Drugs Controller General, India is concerned with
the regulatory control over the quality of drugs & cosmetics. 4

5. Role of D & C Act, 1940
To prevent substandard in drugs & maintaining high
standards of medical care.
To regulate the import, manufacture, distribution and
sale of drugs & cosmetics through licensing.
To regulate the manufacture and sale of Ayurvedic,
Siddha and Unani drugs.
To establish Drugs Technical Advisory Board (DTAB) and
Drugs Consultative Committees (DCC) for Allopathic and
allied drugs & cosmetics.
5

6. Amendments in the Act and adaptation of orders
1. The Repealing and Amending Act, 1949 (40 of 1949)
2. The Adoption of Laws Order, 1950
3. The part B States (Laws) Act, 1951 (3 of 1951)
4. The Drugs (Amendment) Act, 1955 (11 of 1955)
5. The Drugs (Amendment) Act, 1960 (35 of 1960)
6. The Drugs (Amendment) Act, 1962 (21 of 1962)
7. The Drugs and Cosmetics (Amendment) Act, 1964
8. The Drugs and Cosmetics (Amendment) Act, 1972
9. The Drugs and Cosmetics (Amendment) Act, 1982
10. The Drugs and Cosmetics (Amendment) Act, 1986
11. The Drugs and Cosmetics (Amendment) Act, 1995
12. The Drugs and Cosmetics (Amendment) Act,2003
13. The Drugs and Cosmetics (Amendment) Act,2008
14. The Drugs and Cosmetics (Amendment) Act,2013
15. The Drugs and Cosmetics (Amendment) Act,2015
16. The Drugs and Cosmetics (Amendment) Act,2016 6

7. Chapters in D & C Act, 1940
Chapter I- Introduction
Short title, extent and commencement and definitions.
Chapter II- Various Boards
The drugs technical advisory board, the central drugs
laboratory and the drugs consultative committee and its
constitution.
Chapter III- Import of Drugs and Cosmetics
Standards of quality, misbranded drugs, adulterated
drugs ,spurious drugs & cosmetics, and prohibition of
import of certain drugs or cosmetics.
(Cont.)
7

8. Chapters in D & C Act, 1940
Chapter IV- Manufacture, Sale and Distribution of Drugs
and Cosmetics.
Standards of quality, misbranded drugs, adulterated drugs,
spurious drugs & cosmetics, and prohibition of
manufacture, sale and distribution of certain drugs or
cosmetics.
Chapter IV(A)- Provisions relating to Ayurvedic, Siddha
and Unani drugs.
Chapter V- Miscellaneous
Power to give directions, offences by companies,
government departments, penalties and sentences passed
under this Act, Magistrate’s power to impose enhanced
penalties, etc. 8

9. Important definitions in D & C Act, 1940
Drug:
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 Preparations applied on human body
for the purpose of repelling insects like mosquitoes.
Cosmetic:
Any article intended to be rubbed, poured,
sprinkled or sprayed on, or introduced into, or
otherwise applied to, the human body or any part for
cleansing, beautifying, promoting attractiveness, or
altering the appearance Includes any article intended
for use as a component of cosmetic.
(Cont.) 9

10. Spurious drugs:
(a) if it is imported under a name which belongs to
another drug; or
(b) if it is an imitation of, or a substitute for, another
drug or resembles another drug in a manner likely to deceive
or bears upon it or upon its label or container the name of
another drug unless it is plainly and conspicuously marked so
as to reveal its true character and its lack of identity with such
other drug; or
(c) if the label or the container bears the name of an
individual or company purporting to be the manufacturer of
the drug, which individual or company is fictitious or does not
exist; or
(d) if it has been substituted wholly or in part by
another drug or substance; or
(e) if it purports to be the product of a manufacturer of
whom it is not truly a product.
(Cont.) 10

11. Adulterated drugs:
(a) if it consists, in whole or in part, of any filthy, putrid
or decomposed substance; or
(b) if it has been prepared, packed or stored under
insanitary conditions whereby it may have been
contaminated with filth or whereby it may have been
rendered injurious to health; or
(c) if its container is composed in whole or in part, of
any poisonous or deleterious substance which may render the
contents injurious to health; or
(d) if it bears or contains, for purposes of colouring
only, a colour other than one which is prescribed; or
(e) if it contains any harmful or toxic substance which
may render it injurious to health; or
(f) if any substance has been mixed therewith so as to
reduce its quality or strength.
(Cont.)
11

12. Misbranded drugs:
(a) if it is so coloured, coated, powdered or
polished that damage is concealed or if it is made to
appear of better or greater therapeutic value than it
really is; or
(b) if it is not labelled in the prescribed manner;
or
(c) if its label or container or anything
accompanying the drug bears any statement, design
or device which makes any false claiming for the drug
or which is false or misleading.
12

13. Schedules in D & C Act, 1940
There are two Schedules in the Drugs &
Cosmetics Act, 1940.
First Schedule: Names of books under Ayurvedic,
Siddha and Unani systems.
A. Ayurvedic system books like Arogya
Kalpadruma, Arka Prakasha, etc. & Siddha systems
books like Vaidya Thirattu, Therayar Maha
Karisal, etc.
B. Unani system books like Karabadin Qadri,
Karabadin Kabir, etc.
Second Schedule: Various Standards to be Complied
with by Imported Drugs and by Drugs Manufactured for
Sale, Sold, Stocked or Exhibited for Sale or Distributed.
13

14. Schedules in D & C Rules, 1945
Schedule-A
Gives the specimens of prescribed forms necessary for
obtaining licenses, permits, certificates, intimations and
so on.
There are in about 50 forms in this Schedule.
Schedule-B
This Schedule includes fees for test or analysis by the
Central Drug Laboratory or the Government Analyst.
Schedule-B(I)
This Schedule includes fees for the test or analysis by
the Pharmacopoeial Laboratory for Indian Medicine
(PLIM) or the Government analyst.
(Cont.)
14

15. Schedule-C
Includes biological and special products (Parenteral/
Injectable) such as Sera, Vaccines, Antigens, Toxin, Antitoxin,
Insulin, Bacteriophages, solution of serum proteins intended
for injection etc.
Schedule-C(I)
Includes other special products (Non Parenteral) such as
Digitalis Preparations, Fish liver oil, Ergot preparations, Liver
extract, Vitamins, Hormones, In-vitro devices for HIV, HCV etc.
Schedule-D
This Schedule includes Provides extent and conditions of
exemption regarding import of drugs such as Pre-digested
food, Condensed or powdered milk, Cereal preparations,
Chicken essence, Spices and condiments, Drugs and cosmetics
imported for manufacture and export in Special Economic
Zone.
(Cont.)15

16. Schedule-D(I)
Contains information and undertaking required to be
submitted by the manufacturer or his authorized agent with
the Application Form for a Registration Certificate.
The format shall be properly filled in and the detailed
information, secret in nature.
Schedule-D(II)
Includes the information required to be submitted by the
manufacturer for registration of a bulk drug/ formulation/
special product for its import into India.
The format shall be properly filled in and the detailed
information, secret in nature.
Schedule-E
Omitted
(Cont.)
16

17. Schedule-E(I)
List of poisonous substances under the Ayurvedic
(including Siddha) and Unani Systems of Medicine.
•Drugs of Vegetable origin- Bhang, Dhatura, Jaiphala
•Drugs of Animal origin- Snake poison
•Drugs of Mineral origin-Hartala(Arsenic),
Parada(Mercury)
Schedule-F
It includes requirements for the functioning and operation
like Space, equipment and supplies required for a blood bank
and/ or minimum requirement for grant of license for
preparation of blood components from whole human blood.
(Cont.)
17

18. Schedule-F(I)
Part I- Provision applicable to the production of bacterial
and viral vaccines.
Part II- Provision applicable to the production of all sera
from living animals.
Part III- Provision applicable to the production and
standardization of diagnostic agents of bacterial origin.
Schedule-F(II)
Standards for Surgical dressings that include bandage cloth,
absorbent gauze, rolled bandage etc.
Schedule-F(III)
Standards for sterilized Umbilical tapes like umbilical
polyester tape, cotton tape etc.
(Cont.)
18

19. Schedule-FF
It lays down Standards for ophthalmic preparations.
Part-A: Ophthalmic solutions and suspensions.
Part-B: Ophthalmic ointments.
Labelled with words use within 1month of opening, not for
injection, name and concentration of preservatives.
Schedule-G
List of substances required to be used under medical
supervision and accordingly labelled with the words “Caution:
It is dangerous to take this preparation except under
medical supervision”.
Examples are Aminopterin, L-Asparaginase, Bleomycin,
Busulphan, Chlorambucil, Chlorthiazide, Glibenclamide,
Hydantoin, Hydroxyurea, Insulin, Metformin etc.
(Cont.)
19

20. Schedule-H
List of substances (prescription) that should be sold by retail
only on the prescriptions of Registered Medical Practitioner
(R.M.P).
Labelled with the symbol Rx and conspicuously displayed on the
left top corner of the label, labelled with the following words
“To be sold by retail on the prescription of a Registered Medical
Practitioner only”.
Contains a list of 536 drugs.
Schedule-H(I)
Regulates sale of antibiotics.
Labelled Rx in red & displayed on left corner of the label with
red border warnings (1)It is dangerous to take this preparation
except in accordance with the medical advice, (2)Not to be sold by
retail without the prescription of a RMP.
Examples are Alprazolam, Gemifloxacin, Isoniazid, Cefixime,
Levofloxacin, Cefpodoxime, Clofazimine, Zolpidem, etc.
Contains a list of 46 drugs. (Cont.)20

21. Schedule-I
Particulars as to proportion of poison in certain cases
currently not in existence as omitted by the Govt.
Schedule-J
Contains a list of various diseases and conditions which a
drug may not purport to prevent or cure or make claims to
prevent or cure.
No drug may legally claim to treat these diseases.
Examples are AIDS, Blindness, Deafness, Encephalitis,
Diabetes, Fairness of skin, Improvement in height of
children/adults, Obesity, Cancer, Paralysis etc.
(Cont.)
21

22. Schedule-K
Specified drugs are exempted from the provisions of Chapter
IV of the Act & the Rules made there under to the extent and
subject to the conditions specified in that Schedule.
It include Quinine and other antimalarial drugs, Drugs
supplied by RMP to his own patient, Drugs supplied by hospital
or supported by government or local body, Substances which
are used both as articles of food as well as drugs, Household
remedies like Aspirine tab, Paracetamol tab, Analgesic balm,
Gripe water for infants etc.(OTC drugs)
Schedule-L
Omitted
Schedule-L(I)
This Schedule includes Good Laboratory Practices and
requirements of premises and equipments, Chemicals &
Reagents, etc.
(Cont.)
22

23. Schedule-M
Includes Good Manufacturing Practices and requirements of
premises, plant and equipment for manufacture of
pharmaceutical products.
Part 1: Good Manufacturing Practices for premises and materials
1A-Specific requirements for manufacture of sterile
products, parenteral preparations(small volume injectables
& large volume parenterals) and sterile ophthalmic
preparations.
1B-Oral solid dosage forms(Tablets and Capsules)
1C-Oral liquids(Syrups, Elixirs, Emulsions and Suspensions)
1D-Topical products(Creams, Ointments, Pastes, Emulsions,
Lotions, etc.)
1E-Metered-dose-inhalers (MDI)
1F-Specific requirements of premises, plant and materials
for manufacture of Active Pharmaceutical Ingredients
(bulk drugs)
Part 2: Requirements of Plant and equipments. (Cont.) 23

24. Schedule-M(I)
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-N
List of minimum equipments for the efficient running of a
Pharmacy.
Entrance shall bear an inscription “Pharmacy” in front.
(Cont.)
24

25. Schedule-O
Deals with the provisions applicable to disinfectant fluids.
• Part 1: Provisions applicable to black and white fluids
• Part 2: Provisions applicable to other disinfectants
Black fluids are homogeneous dark brown solution of coal tar
acid or similar acids.
White fluids are finely dispersed homogeneous emulsion of coal
tar acid or similar acids.
Schedule-P
It deals with life period of drug and the conditions of the storage
of drugs, period in months (unless otherwise specified) between
date of manufacture and date of expiry.
This schedule includes antibiotics, vitamins, insulin preparation,
normal human plasma, sera toxins, toxoids, other toxins, anti-
toxins, miscellaneous drugs. (Cont.) 25

26. Schedule-P(I)
Specifies the pack size of certain drugs.
The pack sizes for liquid Oral preparations shall be 30ml
(Paediatric only) 60 ml/100 ml/200 ml/450 ml.
Schedule-Q
Gives the list of dyes, colours and pigments permitted to be
used in cosmetics and soaps.
Part1:List of dyes, colours and pigments permitted in cosmetics
and soaps.
Part 2:List of colours permitted in soaps.
Natural colours: Carotene, Chlorophyll, Red Oxide of Iron, Yellow
Oxide of Iron, Titanium Di-oxide, Black Oxide of iron
Artificial Colours: Caramel
Coal Tar Colours (Cont.)
26

27. Schedule-R
Standards for mechanical contraceptives containing label of
the date of manufacture & the date up to which the
contraceptive is expected to retain its properties.
Examples are Condom, Cu-T, etc.
Schedule-R(I)
Standards for medical devices & the following medical
device shall conform to the Indian Standards specification laid
down from time to time by the Bureau of Indian Standards: -
1. Sterile Disposable Perfusion sets for single use only
2. Sterile Disposable Hypodermic Syringes for single use only
3. Sterile Disposable Hypodermic Needles for single use only
(Cont.)
27

28. Schedule-S
Prescribes Standard for Cosmetics & the following cosmetics
in finished form should conform to the specifications laid down
from time to time by the Bureau of Indian Standards (BIS).
Skin Powders, Tooth Powder, Toothpaste, Shaving Creams,
Hair Creams, Shampoo, Nail Polish etc.
Schedule-T
Lays down the Good Manufacturing Practices for Ayurvedic,
Siddha & Unani medicines.
PART-I: Good Manufacturing Practices
PART-II: List of recommended machinery, equipment
& minimum manufacturing premises required for the
manufacture of various categories of Ayurvedic, Siddha
system of medicines. (Cont.)
28

29. Schedule-U
Gives the particulars to be shown in manufacturing records of
Drugs.
Gives the particulars to be recorded of raw materials & gives the
particulars to be recorded in analytical records.
The records or registers shall be retained for a period of 5 years
for Drugs from the date of manufacture.
Schedule-U(I)
Gives the particulars to be shown in manufacturing records of
Cosmetics.
The records or registers shall be retained for a period of 3 years
for Cosmetics from the date of manufacture.
Schedule-V
Give details of standards for patent and proprietary medicines.
(Cont.)
29

30. Schedule-W
Contains the drugs which shall be marketed under generic
names only & the label contains the names and quantities of
active ingredients.
This includes only five drugs marketed under generic names
only Analgin, Aspirin and its salt, Chlorpromazine and its salt,
Ferrous sulphate, Piperazine and its salts.
Schedule-X
Contains a list of 15 narcotic drugs and psychotropic substance.
A label ‘Schedule X drug’ warning: to be sold on retail on
prescription of a RMP only, having ‘NRx’ in red & conspicuously
displayed on the top left corner.
Examples are Phencyclidine, Secobarbital, Amobarbital,
Amphetamines, Glutethimide, Methylphenidate, etc. (Cont.)
These drugs may be imported under license or permit. 30

31. Schedule-Y
This Schedule includes requirements and guidelines for
permission to import and/ or manufacture of new drugs for
sale or to undertake clinical trials.
Includes application for permission of Clinical trial, approval
for trial, responsibilities of sponsor, investigator, ethical
committee, phases I, II, III, IV Studies in special population like
geriatric, paediatric & pregnant women, Post Marketing
Surveillance etc.
Schedule-Y(I)
This Schedule includes Registration of Clinical Research
Organization (CRO) for conducting clinical trials.
It also deals with compensation in case of Injury/ Death
during clinical trial study. 31

32. References
History of D&C Act, 1940.
 http://www.medindia.net/indian_health_act/drugs-and-
cosmetics-act-1940 introduction.htm
 Drugs and Cosmetics Act, 1940.
https://en.wikipedia.org/wiki/Drugs_and_Cosmetics_Act,_19
40#Amendments
Drugs and Cosmetics Rules, 1945.
https://en.wikipedia.org/wiki/Drugs_and_Cosmetics_Rules,_1
945
Ministry of Health and Family Welfare, GSR 588 (E) dated 30
Aug,2013.
Ministry of Health and Family Welfare, GSR 103 (E) dated 02nd
February, 2017.
Dr. B. S. Kuchekar. Pharmaceutical Jurisprudence. Pragati
Books Pvt. Ltd. pp. 5.0–5.2. 32

33. Thank You
33