Introduction to D & C Act 1940 and Rules 1945, Definitions, Various Schedules in D & C Rules 1945, Administration of the act and rules, Manufacturing , Distribution and sale of drug and cosmetic, Labeling and Packing of drug and cosmetic.

1. DRUGS AND COSMETICS
ACT 1940
AND RULES 1945
Dr. Ambekar Abdul Wahid
M. Pharm, Ph.D
Department of Pharmaceutics
Dr. Vithalrao Vikhe Patil Foundation’s
College of Pharmacy
Vadgaon Gupta (Vilad Ghat) PO MIDC
Ahmednagar (MS), India
E-mail: wahidambekar@gmail.com
1

2. History
 British misrule: Providing poor healthcare system to
Indian citizens
 The original act was prepared in accordance to the
recommendations of the R. N Chopra Committee formed
in 1930.
 Observations made by-Drugs Enquiry Committee, Indian
Medical Association.
 Reports in- Indian Medical Gazette during 1920 - 1930.
 1940 – Drugs and Cosmetics Act.
 1945 – Rules under the Act Extended to whole of
India……
2

3. List of Amending Acts and Adaptation Orders
1.The Drugs (Amendment) Act, 1955
2.The Drugs (Amendment) Act, 1960
3.The Drugs (Amendment) Act, 1962
4. The Drugs and Cosmetics (Amendment) Act, 1964
5.The Drugs and Cosmetics (Amendment) Act, 1972
6. The Drugs and Cosmetics (Amendment) Act, 1982
7. The Drugs and Cosmetics (Amendment) Act, 1995
8. The Drugs and cosmetics (Amendment) Act, 2008
9. The Drugs and cosmetics (Amendment) Act, 2013
10. The Drug and cosmetics (Amendment) Act, 2015
11. The Drug and cosmetics (Amendment) Act, 2016
3

4.  To regulate the import, manufacture, distribution and
sale of drugs & cosmetics through licensing.
 Manufacture, distribution and sale of drugs and
cosmetics by qualified persons only.
 To prevent substandard in drugs, presumably for
maintaining high standards of medical treatment.
 To regulate the manufacture and sale of Ayurvedic,
Siddha and Unani drugs.
 To establish Drugs Technical Advisory Board (DTAB)
and Drugs Consultative Committees (DCC) for
Allopathic and allied drugs and cosmetics.
OBJECTIVES
4

5. 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.
Chapters in D & C Act, 1940
Cont…
5

6. 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.
Cont…
6

7. 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.
Chapters in D & C Act, 1940
7

8. 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 (reducing the severity or
painfulness) 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.
Cont…
8

9. 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.
Important definitions in D & C
Act, 1940
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
Cont…
Important definitions in D & C
Act, 1940
10

11. (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…
Important definitions in D & C
Act, 1940
11

12. Cont…
Important definitions in D & C
Act, 1940
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
12

13. (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…
Important definitions in D & C
Act, 1940
13

14. Important definitions in D & C
Act, 1940
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.
14

15. Misbranded Drugs Adulterated Drugs
Spurious Drugs 15

16. Schedules of drugs
The 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. The Rule 67 details the conditions of licenses. The
Rule 97 contains the labeling regulations.
16

17. 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…
17

18. Schedules in D & C Rules, 1945
Cont…
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 Fish liver oil, Ergot preparations, Liver extract,
Vitamins, Hormones, In-vitro devices for HIV, HCV etc.
18

19. 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.
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.
Schedules in D & C Rules, 1945
Cont… 19

20. 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.
Schedules in D & C Rules, 1945
Cont…
20

21. Schedule-E
Omitted
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)
Schedules in D & C Rules, 1945
Cont…
21

22. 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.
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.
Schedules in D & C Rules, 1945
Cont…
22

23. 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.
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.
Schedules in D & C Rules, 1945
Cont…
23

24. The notable Schedules
Schedule G: Most of these drugs are hormonal preparations.
The drug label must display the text "Caution: It is
dangerous to take this preparation except under medical
supervision" prominently.
Examples of substances under this schedule: Testolactone,
Hydroxyurea, Carbutamide, Primidone, Glibenclamide,
Hydroxyurea, Insulin, Metformin etc.
Schedules in D & C Rules, 1945
Cont…
24

25. Schedule H: The drug label must display the texts "Rx" and
"Schedule H drug. Warning : To be sold by retail on the
prescription of a Registered Medical practitioner. It can
only be supplied to licensed parties. It cannot be sold without
a prescription and only the amount specified in the
prescription should be sold. The time and date of prescription
must be noted.
Examples: androgenic, anabolic, oestrogenic and
progestational substances; Alprazolam (Xanax), Hepatitis B
vaccine, Ibuprofen, Vasopressin etc.
Schedules in D & C Rules, 1945
Cont…
25

26. Schedule X: All the regulations of Schedule H apply. The
retailer must keep a copy of the prescription for two years.
The drugs must be kept under lock and key.
Examples: Secobarbital, Glutethimide etc.
Schedule J: Contains a list of various diseases and
conditions that cannot be treated under any drug currently in
market. No drug may legally claim to treat these diseases.
Schedules in D & C Rules, 1945
Cont…
26

27. Schedule K: Contains various substances and drugs and their
corresponding regulation.
Schedule M: Contains various regulations for manufacturing,
premises, waste disposal 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)
Schedules in D & C Rules, 1945
Cont… 27

28. 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 equipment's.
Schedules in D & C Rules, 1945
Cont… 28

29. 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.
Schedules in D & C Rules, 1945
Cont… 29

30. Schedule N: List of minimum equipments for the efficient
running of a Pharmacy. Entrance shall bear an inscription
“Pharmacy” in front.
Schedule O: Contains various regulations and requirements
for disinfectant fluids.
Schedule P: Contains regulations regarding life period and
storage of various drugs.
Schedule P-I: Contains regulations regarding retail package
size of various drugs
Schedules in D & C Rules, 1945
Cont… 30

31. Schedule Q: Contains a list of permitted dyes and pigments
in soap and cosmetics.
Schedule R: Contains various regulations and requirements
for condoms and other mechanical contraceptives.
Schedule S: Lists various cosmetics and toiletries, and
directs the manufacturers of cosmetics to conform to the
latest Bureau of Indian Standards requirements.
Schedules in D & C Rules, 1945
Cont… 31

32. Schedule T: Contains various regulations and requirements
for manufacture of Ayurvedic, Siddha and Unani products.
Schedule U: Contains various regulations and requirements
for record keeping.
Schedule V: Contains standards for drug patents.
Schedule Y: Contains requirement and guidelines for
clinical trials.
Schedules in D & C Rules, 1945
32

33. Administration of the act and rules
A) Advisory:
1) Drugs Technical Advisory Board (DTAB)
2) Drugs Consultative Committee (D.C.C.)
B) Analytical:
1) Central Drugs Laboratory (CDL)
2) Drug Control Laboratory in States
3) Government Analysts
C) Executives:
1) Licensing authorities
2) Controlling authorities
3) Drug Inspectors
33

34. Drugs Technical Advisory Board
(DTAB)
Ex-Officio:
(i) Director General of Health Services (Chairman)
(ii) Drugs Controller, India
(iii) Director of the Central Drugs Laboratory, Calcutta
(iv) Director of the Central Research Institute, Kasauli
(v) Director of Indian Veterinary Research Institute, Izatnagar
(vi) President of Medical Council of India
(vii) President of the Pharmacy Council of India
(viii) Director of Central Drug Research Institute, Lucknow
Cont… 34

35. Nominated:
1) Two persons by the Central Government from among
persons who are in charge of drugs control in the States.
2) One person by the Central Government from the
pharmaceutical industry.
3) Two persons holding the appointment of Government
Analyst under this Act, to be nominated by the Central
Government.
Drugs Technical Advisory Board
(DTAB)
Cont… 35

36. Elected:
1) One person, to be elected by the Executive Committee of the
Pharmacy Council of India.
2) One person, to be elected by the Executive Committee of the
Medical Council of India.
3) One pharmacologist to be elected by the Governing Body of
the Indian Council of Medical Research.
4) One person to be elected by the Central Council of the
Indian Medical Association.
5) One person to be elected by the Council of the Indian
Pharmaceutical Association.
Drugs Technical Advisory Board
(DTAB)
Cont… 36

37. Functions:
 To advise the Central Government and the State
Governments on technical matters arising out of the
administration of this Act.
 To carry out the other functions assigned to it by this Act.
(The nominated and elected members of the Board shall hold
office for three years, but shall be eligible for re-nomination
and re-election)
Drugs Technical Advisory Board
(DTAB)
37

38. Drugs Consultative Committee (DCC)
It is also an advisory body constituted by central government.
Constitution:
• Two representatives of the Central Government.
• One representative of each State Government.
Cont… 38

39. Functions:
 To advise the Central Government, the State Governments
and the Drugs Technical Advisory Board on any other
matter tending to secure uniformity throughout India in
the administration of this Act.
 The Drugs Consultative Committee shall meet when
required.
 Has power to regulate its own procedure.
Drugs Consultative Committee (DCC)
39

40.  The Central Drugs Laboratory, Kolkata is the national
statutory laboratory of the Government of India for quality
control of Drugs and Cosmetics.
 Established under the Indian Drug & Cosmetics Act, 1940.
 It is the oldest quality control laboratory of the Drug Control
Authorities in India.
 It functions under the administrative control of the Director-
General of Health Services in the Ministry of Health and
Family Welfare.
Central Drug Laboratory (CDL)
Cont… 40

41. Regional Offices: Total 07
 Central Drugs Laboratory (CDL), Kolkata, West Bengal.
 Central Drugs Testing Laboratory (CDTL) Chennai , Tamil
Nadu.
 Central Drugs Testing Laboratory (CDTL) Hyderabad, AP.
 Central Drugs Testing Laboratory (CDTL) Mumbai,
Maharashtra.
 Regional Drugs Testing Laboratory (RDTL) Guwahati,
Assam.
 Regional Drugs Testing Laboratory (RDTL) Chandigarh.
 Central Drugs Laboratory (CDL) Kasauli.
Central Drug Laboratory (CDL)
41Cont…

42. Central Drug Laboratory (CDL)
Functions:
• Analysis or test of samples of drugs/cosmetics sent by the
custom collectors or courts.
• Analytical Q.C. of the imported samples.
• Collection, storage and distribution of internal standards.
• Preparation of reference standards and their maintenance.
• Maintenance of microbial cultures.
• Any other duties entrusted by Central Government.
• Acting as an appellate authority in matter of disputes.
42

43. The functions of the Laboratory in respect of the following
Drugs or classes of drugs shall be carried out at the Central
Research Institute, Kasauli,
1. Sera
2. Solution of serum proteins intended for injection
3. Vaccines
4. Toxins
5. Antigens
6. Anti-toxins
7. Sterilized surgical ligature and sterilized surgical suture.
8. Bacteriophages
43
Central Drug Laboratory (CDL)
Cont…

44. The functions of the Laboratory in respect of Oral Polio
Vaccine shall be carried out by the following Institutes –
A) Pasteur Institute of India, Coonoor.
B) Entero virus Research Centre (Indian Council of Medical
Research), Haffkin Institute Compound, Parel, Mumbai.
C) The National Institute of Biologicals, NOIDA.]
44
Central Drug Laboratory (CDL)
Cont…

45. The functions of the Laboratory in respect of the following drugs
or classes of drugs shall be carried out at the Indian Veterinary
Research Institute, Izatnagar or Mukteshwar and the
functions of the Director in respect of the said drugs or classes
of drugs shall be exercised by the Director of either of the said
institutes.
1. Anti-sera for veterinary use.
2. Vaccines for veterinary use.
3. Toxoids for veterinary use.
4. Diagnostic Antigens for veterinary use
45
Central Drug Laboratory (CDL)
Cont…

46. The functions of the Laboratory in respect of human blood and
human blood products including components
 To test for freedom of HIV antibodies, shall be carried out
by the following Institutes-
(A) National Institutes of Communicable Disease, Department of
Microbiology, Delhi.
B) National Institute of Virology, Pune
C) Centre of Advanced Research in Virology, Christian Medical
College, Vellore
46
Central Drug Laboratory (CDL)

47.  The functions of the Laboratory in respect of
Homoeopathy shall be carried out at the Homoeopathy
Pharmacopoeia Laboratory, Ghaziabad.
 The functions of the Laboratory in respect of Blood
Grouping reagent and diagnostic kits for Human
Immuno deficiency Virus, Hepatitis B Surface Antigen
and Hepatitis C Virus shall be carried out at the National
Institute of Biologicals, NOIDA.
47
Central Drug Laboratory (CDL)

48. Government analyst
These officers are appointed by the central or state
government and perform the duties.
Qualification:
1. Persons having qualification for appointment as
government as governmental Analysis for allopathic
drugs;
2. Having a degree in medicine, ayurved, sidha or unani
system and not less than three year post graduate
experience in the analysis of drugs in a laboratory
under control of a government analyst.
48Cont…

49.  A post graduated degree in medicine or science or pharmacy or
pharmaceutical chemistry of a recognized university or has an equivalent
qualification recognized and notified by central government for such
purpose.
 Associated Diploma of the Institution of chemists (India) with Analysis
of Drug and pharmaceuticals as one of the subjects and had not less than 3
years experience in the testing of drug in labrotary under the control of,
a) A government analyst
b) Head of an Institution or testing laboratory approved for the purpose by
the appointing authority or has completed two years training or testing of
drugs, including items stated in schedule C in Central Drug Laboratory.
49
Government analyst
Cont…

50. Duties:
1) The Government Analyst shall cause to be analyzed or
tested such samples or drugs and cosmetics as may be
sent to him by
Drug Inspectors.
2) A Government Analyst shall from time to time forward
reports to the Government giving the result of analytical
work and research with a view to their publication.
50
Government analyst
Cont…

51. Procedure on receipt of sample:
 On receipt of a package of a sample from drug Inspector, the
government analyst compares the seal on the package or on portion
of sample or container with specimen impression of the seal
received separately and notes condition of seal on the pack or on the
portion of sample or container.
 On completion of test or analysis he supplied to the inspector a report
of analysis in triplicate, together with full protocols of the test
applied.
 If purchaser wants to analyze or test drug or cosmetic he has to make
an application for test or analysis in form accompanied with
prescribed fees and the report of test or analysis of such drug or
cosmetic is to be supplied in form by government analyst.
51
Government analyst

52. Licencing authority
Qualification:
(i) Graduate in Pharmacy on Pharmaceutical Chemistry or
in Medicine with specialization in clinical pharmacology or
microbiology from a University established in India by law;
and
(ii) Experience in the manufacture or testing of drugs a
minimum period of five years, Provided that the requirements
as to the academic qualification shall not apply to those
inspectors .
52Cont…

53. Duties:
1. To inspect all establishments licensed for the sale of
drugs within the area assigned to him;
2. To satisfy himself that the conditions of the licences are
being observed;
3. To procure and send for test or analysis, if necessary,
imported packages.
4. To investigate any complaint.
53
Licencing authority
Cont…

54. 5. To maintain a record of all inspections made and action
taken by him in the performance of his duties,
6. To make such enquiries and inspections as may be
necessary to detect the sale of drugs in contravention to
the Act;
54
Licencing authority

55. 55
Controlling authority
Qualification:
 Graduate in Pharmacy or Pharmaceutical Chemistry
or in Medicine with specialization in clinical
Pharmacology or microbiology from a University
established in India by law and
 Experience in the manufacture or testing of drugs or
enforcement of the provisions of the Act for a minimum
period of five years:

56. Drug Inspector
 A person to be appointed as a Drug Inspector should
have No financial interest in the import, manufacture or
sale of the drug or cosmetics,
 Drug Inspector is a Public Servant under sec 21 of
Indian panel code.
56Cont…

57. Qualification
A person who is appointed an Inspector under the Act
shall be a person who has a degree in Pharmacy or
Pharmaceutical Sciences or Medicine with Specialization
in clinical Pharmacology or Microbiology from a
University established in India by law-
57
Drug Inspector
Cont…

58. Provided that only those Inspectors: --
(i) Who have not less than 18 months experience in the
manufacture of atleast one of the substances specified
in Schedule C, or
(ii) Who have not less than 18 months’ experience in
testing of atleast one of the substances in Schedule C in
a Laboratory approved for this purpose by the licensing
authority, or
(iii) Who have gained experiences of not less than three
years in the inspection of firms manufacturing any of the
substances specified in Schedule C during the tenure of
their services as Drugs Inspector; shall be authorized to
inspect the manufacture of the substances mentioned in
Schedule C.
58
Drug Inspector

59. 59
Power of inspectors
a) Inspect
(i) Any premises where in any drug or cosmetic is being
manufactured.
(ii) Any premises where in any drug or cosmetic is being
sold, or stocked or exhibited or offered for sale, or
distributed;
(b) Take samples of any drug or cosmetic
(i) Which is being manufactured or being sold or is stocked
or exhibited or offered for sale, or is being distributed;
(ii) From any person who is in the course of conveying,
delivering or preparing to deliver such drug or cosmetic
to a purchaser or a consignee.
Cont…

60.  Search any person in connection with the offence (fault)
 Enter and search at all reasonable times any place or
premises in which he has reasoned to believe that an offence
is being committed or has been committed
 Stop and Search any vehicle or other conveyance which he
has reason to believe, used for carrying any drug or cosmetic
in respect of which offence has been or has being committed.
 Examine any record, register, document or any other material
object found while exercising above powers and sieze (Catch,
hold)) the same if he has reason to believe that it is an
evidence of the commission of an offence under the act.
Power of inspectors
Cont… 60

61.  Give order in writing to the person in possession of drug or
cosmetic in respect of which offence has been committed or is
being 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 size the stock of such drug or
cosmetic or any substance or article employed for
commission of offence.
61
Power of inspectors

62. Penalty for obstructing Inspector
If any person willfully obstruct an Inspector in the exercise
of the powers conformed upon him or refuse to produce any
record, register or any other document when required or
any document when required, he shall be punishable with
imprisonment (jail) up to 3 year or with fine or with both.
62

63. Manufacture, Sale & Distribution of
Drugs and Cosmetics
MANUFACTURE
PROHIBITION OF MANUFACTURE
 Drug not of standard quality or misbranded, adulterated
or spurious.
 Patent or Proprietary medicine.
 Drugs which claims to cure diseases specified in Sch-J.
 Drugs which are Risky to human beings or animals.
 Drugs without therapeutic value.
63

64. Types of manufacturing license
64
Sch.-X Sch.-C/C1 & X Drugs for the
purpose of
examinationtest
or analysis
Own Premises
Own Premises
Sch.- C/C1
But not-X
Other thanSch.-
C/C1 &X
Own Premises
Loan License
Repacking
license
AllopathicDrugs

65. Manufacturing of drugs other than in
Schedule C/C1
Conditions:
 Premises should comply with schedule ‘M’.
 Adequate facility for testing, separate from manufacturing.
 Adequate storage facility.
 Records of mfg. & testing-maintained for at least 2 years
from date of Exp.
 License should provide sample to authority.
 Furnish data of stability.
 Maintain the inspection book.
 Maintain reference samples from each batch.
 Accounts of production recorded & maintained for 5 years
or 1 year after Expiry.
65

66. Manufacture of Schedule X drugs
Conditions:
 Have to sent invoice of sale to licensing authority every 3
months
 Store drugs in direct custody of responsible person.
 Preparation must be labeled with XRx
 Marketed in packing not exceeding
 100 unit dose –Tablets/Capsules
 300 ml- Oral liquid
 5 ml - Injection
66

67. Manufacture of drugs those in Schedule
C/C1 (Biological)
Conditions:
 Drugs must be issued in previously sterilized sealed glass or
suitable container.
 Containers should comply with requirement of Schedule-
F/F1.
 Drug must comply with standard (quality, purity, strength)
specified in schedule-F.
 Parenteral in doses of 10 ml or more should be tested for
freedom from Pyrogens.
 Separate laboratory for culture and manipulation of spore
bearing Pathogens.
 Test for sterility should be carried out.
67

68. Penalties related to Manufacture
68
Offences Penalties
Manufacture of any spurious
drugs
a) 1-3 years imprisonment and Rs. 5000
fine
b) 2-6 years imprisonment & Rs.10000
fine on subsequent conviction
Manufacture of adulterated
drugs
a) 1 year imprisonment & Rs.2000 fine
b) 2 years imprisonment & Rs.2000 fine
for subsequent conviction
Manufacture of drugs in
contravention of the
Provisions
a) Imprisonment up to 3 months & Rs.
500 fine.
b) Imprisonment up to 6 months &
Rs.1000 fine on subsequent conviction

69. Loan License
Definition:
A person (applicant) who does not have his own arrangements
(factory) for manufacture but who wish to avail the
manufacturing facilities owned by another licensee Such
licenses are called Loan licenses.
Procedure:
Licence is obtained from licensing authority (FDA) on
application in prescribed forms (24-A , 27-A) with prescribed
fees (Rs. 6000, 1500).
Loan licenses are issued for:
1) Drugs other than specified in schedule C/C1 & X.
2) Drugs specified in schedule-C/C1
69

70. Repackaging license
Definition:
Process of breaking up any drug from a bulk container into
small packages and labeling with a view to their sale and
distribution.
Repackaging of drugs is granted for drugs other than
Schedule C/C1 and X.
Procedure:
Licence is obtained from licensing authority (FDA) on
application in prescribed forms (24-B) with prescribed fees
(Rs. 500, 200).
70

71. Manufacture of cosmetics
Prohibited for the following classes of drug:
 Misbranded or spurious cosmetics and of substandard
quality.
 Cosmetics containing hexachlorophene or mercury
compounds.
 Cosmetics containing color which contain more than-
- 2 ppm of arsenic,
- 20 ppm of lead
- 100 ppm of heavy metals
 Eye preparations containing coal-tar color
71

72. Sale of drugs
72
Allopathic Drugs
Whole Sale Retail Sale Sales From
Motor Vehicle
( Vendor)
General License Restricted
License
Drugs other
than sch.-
C/C1 & X
Drugs in
Sch.- C/C1
Drugs in
Sch.- X
For
Sch.- C/C1

73. Classes of drugs prohibited to be
sold
 Misbranded, spurious, adulterated and drugs not of
standard quality
 Patent/Proprietary drugs with undisclosed formula.
 Sch-J drugs
 Expired drugs.
 Drugs used for consumption by government schemes such
as Employment State Insurance Scheme (E.S.I.S.),
Armed force.
 Physician’s samples.
73

74. Wholesale of Other Than Those
Specified In C/C1 And X
 All the conditions as discussed in for biological.
 Compounding is made by or under the direct and personal
supervision of a qualified person.
74

75. Wholesale Of Biological (C/C1)
 Adequate premises, with greater than 10 M2 area, with
proper storage facility.
 Drugs sold only to retailer having license.
 Premises should be in charge of competent person who is
Reg. Pharmacist.
 Records of purchase & sale.
 Records preserved for 3 years from date of sale.
 License should displayed on premises.
75

76. Retail sale
 For retail sale, two types of licenses are issued:
i) General licenses
ii) Restricted licenses
 Restricted license:
Granted to those dealers who do not engage the services of
a qualified person and only deal with such classes of drugs
whose sales can be effected without qualified person and
vendors who do not have fixed premises.
76

77. Labeling & Packaging
 A minimum area of 50 square meters shall be provided
for packing and labeling section.
 All the general and specific labeling and packaging
specified to all classes of drugs and cosmetics should be
as per the provisions made under the act.
 No person sell or distribute any drug unless it is labeled
in accordance with the Rules (Rule 95 of D & C Act).
77Cont…

78. Label – why?
Label is
 A bridge between the producer and consumer.
 Identification of the product, its contents, dosage
form.
 Name and address of producer – to contact, if
needed.
 Cautions & warnings.
 Directions for use.
 Batch number, date of manufacture, date of expiry.
 Storage conditions.
 Maximum retail price.
 And insures against counterfeiting/ spurious
products.
78
Labeling & Packaging
Cont…

79. Importance of labeling
 The safe use of all medicines depends on users reading
the labeling and packaging carefully and accurately and
being able to assimilate and act on the information
presented.
 All labels must be clear and concise and must bear all
necessary information regarding the safe use of a product.
79
Labeling & Packaging
Cont…

80. Label – Pharmacopoeia defines:
Label means any printed packaging material, including
package inserts that provide information on the article.
( I.P. 2007 )
The term LABELLING designates all labels and other
written, printed or graphic matter upon an immediate
container of an article or upon, or in, any package or
wrapper in which it is enclosed, except any outer shipping
container. The term label designates that part of labelling
upon the immediate container. (U.S.P)
80
Labeling & Packaging
Cont…

81. A label is a piece of paper, polymer, cloth, metal, or other
material affixed to a container or article, on which is printed
a legend, information concerning the product, addresses,
etc. A label may also be printed directly on the container or
article.
( Wikipedia, the free encyclopedia)
FDA has asserted that oral statements by sales
representatives , speeches in CME programs and lectures
are “labeling”
81
Labeling & Packaging
Cont…

82. Components of Labeling:
The prescription drug labeling consists of following
components:-
 Container/ Carton Label
 Package Insert
Regulatory Requirements for Label :-
Rule 96 of the Drug and Cosmetic Rules (manner of
labelling) mandates the minimum information which
needs to be put on the label of all medicines.
82
Labeling & Packaging

83. The following particulars shall be either printed or written
in indelible ink and shall appear in a conspicuous manner
on the label of the innermost container of any drug and on
every other covering which the container is packed, namely
:-
1. Name of the drug
• Proper name, conspicuously, and brand name, if any
• Inclusion of the letters, I.P, NFI, B.P, USP, INN, or
descriptive of the true nature or origin ( generic name)
2. Net Quantity of contents
3. The content of active ingredients
83Cont…
Labeling & Packaging

84. 4. Name and Address of manufacturer
5. Batch or lot number(Batch No.)
6. Manufacturing license number (“Mfg. Lic. No.”)
7. Import License No. (if applicable):- the no. of license
under which the drug is imported, preceded by words
“Import Lic. No.”
8. Manufacturing date, Expiry date and Storage conditions
84
Labeling & Packaging
Cont…

85. 9. Other Specific Requirements
i. Physician Sample – ‘Not to be sold’.
ii. Alcohol content (if not less than 3%)
iii. Red vertical line - of not less than 1mm thickness.
(falling under schedule G, H, X, narcotic analgesics,
hypnotics, sedatives, tranquilizers, corticosteroids, hormones,
hypoglycemics, antimicrobials, antiepileptics, anticancer
drugs)
* Exceptions – Vet. drugs, external use, ophthalmic
preparations, ear drops, sterile sutures, surgical
dressings, preparations for parenteral use.
85
Labeling & Packaging
Cont…

86. Package Inserts
 The Package insert is considered “adequate direction for
use”.
 It is also directed to healthcare professional and help him
in making correct decision regarding the prescribing of drug
to a particular patient.
 In India, it is governed by the ‘Drugs and Cosmetics
Act(1940) and Rules (1945). Schedule D 11 (section 6) of the
rules including the heading to which information to be
provided in the Package Inserts.
 It is divided into two parts:
 Therapeutic indications
 Pharmaceutical information
86
Labeling & Packaging

87. Schedule G drug: “Caution: it is dangerous to take this
preparation except under medical supervision”
- Conspicuously printed, Surrounded by a line, No other
words. (Exception topical / external preparations.)
Schedule H drug:
• Rx on the left top corner conspicuously
• Schedule H drug: Warning: to be sold by retail on the
prescription of a Registered Medical Practitioner
only.
87
Contents of a label (Medicines )
Cont…

88. Schedule H drug – falling under NDPS Act, 1985
• NRx, in red colour, on the left top corner, conspicuously
• Schedule H drug: Warning: to be sold by retail on the
prescription of a Registered Medical Practitioner only.
Schedule H drug – specified in Schedule X
XRx, in red colour ,on the left top corner, conspicuously.
Schedule X drug – warning: to be sold by retail on the
prescription of a Registered Medical Practitioner only.
* if it is a bulk packing - only XRx in red colour, displayed
conspicuously
88
Contents of a label (Medicines )
Cont…

89.  Liniment, lotion etc.: “FOR EXTERNAL USE ONLY.”
 Contains industrial methylated spirit (for human use)
- declare the fact & “For external use only.”
 If for veterinary use – “ Not for human use; for animal
treatment only ” and shall bear a symbol depicting the
head of a domestic animal.
 Names of the approved colours added, if any.
 Non sterile surgical ligatures & sutures:
“non sterile surgical ligature ( suture ) – not to be used for
operations upon the human body unless efficiently sterilized.”
89
Contents of a label (Medicines )

90. If, targeted for export:
 Regulations of the importing country shall be adhered to.
 Shall contain name & address of the manufacturer (code
number - if requested by the consignee)
If targeted for sale or consumption in India
 Shall be manufactured by a licensed manufacturer.
 Shall be labeled as prescribed.
 Shall not contain misleading / false claims.
90
Contents of a label (Cosmetics )

91. Shall be labeled on inner and outer label
 Name of the cosmetic,
 Name and address of the manufacturer (if the container is
so small the name and principal place of business)
 Use before ….. ,
 Net contents (On outer label )
 Adequate directions for use, warning, caution or special
directions, names and quantities of hazardous/poisonous
materials added (where hazard exists)
91
Contents of a label (Cosmetics )

92. • Batch number, preceded by “B”
• Manufacturing license number – preceded by “M”,
• List of ingredients of more than or equal to 1%, in the
order of addition, in descending order (exemption to less
than 60 ml/ 30 gm), preceded by the words
“INGREDIENTS”
• Schedule- S, r.w. BSI specifications, if any.
( directions issued by licensing authority)
92
Contents of a label (Cosmetics )

93. Toothpaste containing fluoride: Content of fluoride in ppm
(shall not be more than 1000 ppm)
• Date of expiry on tube and cartoon.
• Note:-Medicated toothpastes are drugs.
Hair dyes containing dyes, colours, pigments – shall bear
a caution (R-149)
“Caution: This product contains ingredients which may
cause skin irritation in certain cases and so a preliminary
test according to the accompanying direction should first be
made. This product should not be used for dyeing the eye-
lashes or eye-brows as such a use may cause blindness”.
93
Contents of a label (Cosmetics )

94. Each package shall also contain instructions in English
and local languages on the following lines for carrying
out the test:
“This preparation may cause serious inflammation of the
skin in some cases and so a preliminary test should always
be carried out to determine whether or not special
sensitivity exists. To make the test, cleanse a small area of
skin behind the ear or upon the inner surface of the
forearm, using either soap and water or alcohol. Apply a
small quantity of the hair dye as prepared for use to the
area and allow it to dry. After twenty-four hours, wash the
area gently with soap and water. If no irritation or
inflammation is apparent, it may be assumed that no
hypersensitivity to the dye exists. The test should, however,
be carried out before each and every application. This
preparation should on no account be used for dyeing eye-
brows or eye-lashes as severe inflammation of the eye or
even blindness may result”.
94
Contents of a label (Cosmetics )

95. Examples of label
95

96. 96
Examples of label

97. Packing of Drugs
97
 The pack sizes of drugs meant for retail sale shall be
as prescribed in Schedule P-1 to these rules.
 The pack sizes of drugs not covered by the Schedule P-
1 shall be as given below: Unless specified otherwise in
Schedule P-1,

98. i. The pack sizes for Tablets/Capsules shall be: Where the
number of Tablets (coated or uncoated)/Capsules (hard or
soft gelatine) is less than 10, such packing shall be made by
the integral number. For numbers above 10, the pack sizes
of Tablets/Capsules shall contain multiples of 5.
ii. The pack sizes for liquid Oral preparations shall be 30 ml
(paediatric only) 60 ml/100 ml/200 ml/450 ml.
iii. The pack sizes for Paediatric Oral Drops shall be 5 ml/l0
ml/15 ml.
iv. The pack sizes for Eye/Ear/Nasal drops shall be 3 ml/5
ml/10 ml.
v. The pack sizes for Eye Ointment shall be 3 gm/5 gm/10
gm.
98
Packing of Drugs

99. Packing of drugs specified in Schedule X: The drugs
specified in Schedule X shall be marketed in packings not
exceeding-
(i) 100 unit doses in the case of tablets/capsules.
(ii) 300 ml in the case of oral liquid preparation.
(iii) 5 ml in the case of injections.
99
Packing of Drugs

100. Packing of drugs for hospital or
dispensary
Nothing in the rule shall apply to packing meant for use of a
hospital or a dispensary subject to the conditions that:
a. Such supplies are made by the manufacturers or
distributors direct to the hospitals/ dispensaries.
b. Hospital packs shall not be supplied to a retail dealer or
to a Registered Medical Practitioner.
100

101. References
1. The drugs and cosmetics rules, 1945 [As amended up
to 15th August, 2013].
2. A text book of forensic pharmacy by N.K Jain. Vallabh
Prakashan.
3. Handbook of drug law by M. L. Mehra.
4. Forensic pharmacy, 9th edition. Nirali Prakashan by
Kuchekar B.S.
5. Pharmaceutical regulatory affairs by Subrahmanyam
C.V.S and Thimma Setty J. Vallabh Prakashan.
101

102. Thank You
102