1. Prepared by :
Rakshit V. Thumar
M.Pharm Q.A. SEM-II
Guided by:
Ms. Urvisha V. Bangoriya
Assistant professor
Quality Assurance Department
S. J. Takkar Pharmacy college
Rajkot
SJTPC 1

2. Contents
 History and Objectives
 Definitions
 Administration of the act and rules
 Provisions related to Import
 Provisions related to Manufacture
 Provisions related to Sale
 Labeling and Packaging
 Schedules to the act and rules
 Recent amendment act, 2008
 List of forms
SJTPC 2

3. History
 British misrule-Providing poor healthcare system to
Indian citizens
 Observations made by-Drugs Enquiry
Committee, Indian Medical Association
 Reports in- Indian Medical Gazette during 1920-30
 1940 – Drugs and Cosmetics Act
 1945 – Rules under the Act
Extended to whole of India……
SJTPC 3

4. 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
SJTPC 4

5. Objectives
 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.
 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.
SJTPC 5

6. Definitions
Drugs :
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.
SJTPC 6

7. 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 thereof for
cleansing, beautifying, promoting
attractiveness, or altering the appearance, and
includes any article intended for use as a
component of cosmetic.
SJTPC 7

8.  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.
SJTPC 8

9.  Adulterated drug :
(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.
SJTPC 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
SJTPC 10

11.  Manufacture :
In relation to any drug or cosmetic, it
includes any process or part of a process for
making, altering, ornamenting, finishing, pac
king, 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.
SJTPC 11

12.  Patent or Proprietary 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
authorized in this behalf by the Central
Government.
SJTPC 12

13. 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
SJTPC 13

14. 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
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15.  Nominated:
1) Two persons by the Central Government.
2) One person by the Central Government from
the pharmaceutical industry
3) Two persons holding the appointment of
Government Analyst under this Act,
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16.  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;
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17.  Functions:
To advise the Central Government and the
State Governments on technical matters.
To carry out the other functions assigned to it by
this Act.
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18. Drugs Consultative Committee(DCC)
 It is also an advisory body constituted by central
government.
 Constitution:
Tworepresentatives of the Central
Government
One representative of each State
Government
SJTPC 18

19.  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.
SJTPC 19

20. Central Drug Laboratory(CDL)
 Established in Calcutta, under the control of a director
appointed by the Central Government.
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.
SJTPC 20

21. Drug control laboratories in state
In gujarat three laboratories established which
collect, analysed and report the various sample of the drugs
and food.
1) Baroda: Established in 1959.
2) Bhuj: Established in 1979.
3) Rajkot: Established in 1983
The laboratory has the following devision:-
 Pharmaceutical Chemistry Division
 Immunology Division
 Pharmacology Division
 Pharmacognocy Division
 Food Division
 Ayurvedic Division
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22. Function:
 Testing of drug sample
 Analysis of food sample
 Analysis of exicse sample
SJTPC 22

23. Government analyst
 These officers are appointed by the central or state
government and perform the duties.
Qualification of government analysist
1 Persons having qualification for appointment as
government as govermental 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.
SJTPC 23

24. Duties:
 1) The Government Analyst shall cause to be
analysed or tested such samples or drugs
and cosmetics as may be sent to him by
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.
SJTPC 24

25. 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 .
SJTPC 25

26. 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.
SJTPC 26

27. (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;
SJTPC 27

28. 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:
SJTPC 28

29. Drug Inspector
Qualification
1 Persons having qualification for appointment as
government as govermental Analysis for allopathic
drugs ; or
2 having a degree in 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) a government analyst, or (b) a chemical
examinar, or (c) head of an institution specially
approved for this purpose.
SJTPC 29

30. Power:
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.
SJTPC 30

31. Provision
of Act
Manufacturi Labeling
Import Sales
ng &
Packaging
SJTPC 31

32. IMPORT
SJTPC 32

33. IMPORT of drugs
 Classes of drugs prohibited to import
 Import of drug under license
1)Specified in Schedule-C/C1
2)Specified in Schedule-X
3)Imported for Test/Analysis
4)Imported for personal use
5)Any new drugs
 Drugs exempted from provisions of import
 Offences and Penalties
SJTPC 33

34. Classes of drugs prohibited to
import
 Misbranded drugs
 Drugs of substandard quality
 Drugs claiming to cure diseases specified in Sch-J
 Adulterated drugs
 Spurious drugs
 Drugs whose manufacture, sale/distribution are
prohibited in original country, except for the purpose
of test, examination and analysis.
 Patent/Proprietary medicines whose true formula is
not disclosed.
SJTPC 34

35. Import of the biological
drugs(C/C1)
Conditions to be fulfillled:
 Licensee must have adequate facility for the storage.
 Licensee must maintain a record of the sale.
 Licensee must allow an inspector to inspect premises
and to check the records.
 Licensee must furnish the sample to the authority.
 Licensee must not sell drugs from which sample is
withdrawn and he is advised not to sale, and recall the
batch from the market.
SJTPC 35

36. Import of the Schedule-X drugs
(Narcotic & Psychotropic drugs)
Conditions to be fulfilled:
 Licensee must have adequate storage facility.
 Applicant must be reputable in the
occupation, trade or business.
 The license granted even before should not be
suspended or cancelled.
 The licensee has not been convicted any
offence under the Drugs and Cosmetics Act or
Narcotic and Psychotropic Substances Act.
SJTPC 36

37. Drugs Imported for
examination, test or analysis
Conditions to be fulfilled:
 License is necessary under form-11
 Must use imported drugs only for said purpose
and at the place specified in the license.
 Must keep the record with respect to
quantities, name of the manufacturer and date of
import.
 Must allow an inspector to inspect the premises
and check the records.
SJTPC 37

38. Drugs imported for personal use
Conditions to be fulfilled:
 Up to 100 average doses may be imported
without any permit, provided it is part of
passenger’s luggage.
 More than 100 doses imported with license.
Apply on form no.-12-A,12-B
 Drugs must be bonafide personal use.
 Drugs must be declared to the custom
collectors if so directed.
SJTPC 38

39. Import of drugs without license
 Substances not used for medicinal pupose
 Drugs in Sch-C1 required for manufacturing and not for
medicinal use.
 Substances which are both drugs and foods such as:
Condensed/Powdered Milk
Malt
Lactose
Farex/Cereal
Oats
 Predigested foods
 Ginger, Pepper, Cumin, Cinnamon
SJTPC 39

40. Penalties related to Import
OFFENCES PENALTIES
Import of spurious OR a) 3 years imprisonment and
adulterated drug OR drug which 5000 Rs. fine on first
involves risk to human beings or conviction
animals OR drug not having b) 5 years imprisonment OR
therapeutic values 1000 Rs. fine OR both for
subsequent conviction
Contravention of the provision a) 6 months imprisonment OR
500 Rs. fine OR both for first
conviction
b) 1 year imprisonment OR 1000
Rs. fine for subsequent
offence
SJTPC 40

41. Cosmetics prohibited to import
 Misbranded cosmetics
 Spurious cosmetics
 Cosmetic containing harmful ingredients
 Cosmetics not of standard quality
 which contains more than-2 ppm Arsenic, 20 ppm
lead, 100 ppm heavy metals
SJTPC 41

42. MANUFACTURE
SJTPC 42

43. Manufacture
 Prohibition of manufacture
 Manufacture of other than in Sch-C/C1
 Manufacture of those in Sch-C/C1
 Manufacture of Sch-X drugs
 Loan license
 Repackaging license
 Offences & Penalties
SJTPC 43

44. Prohibition of manufacture
 Drug not of standard quality or misbranded,
adulterated or spurious.
 Patent or Proprietary medicine
 Drugs in Sch-J
 Risky to human beings or animals
 Drugs without therapeutic value
 Preparation containing cyclamates
SJTPC 44

45. Manuf. of drugs other than in Sch-
C/C1
Conditions:
 Premises should comply with schedule ‘M’
 Adequate facility for testing, separate from
manufacturing
 Adequate storage facility
 Records maintained for at least 2 years from date of
Exp.
 Should provide sample to authority
 Furnish data of stability
 Maintain the inspection book
 Maintain reference samples from each batch
SJTPC 45

46. Manuf. 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 Sch-F
 Some classes tested for aerobic & anaerobic micro-
organism.eg. Sera ,Insulin, Pituitary hormones.
 Serum tested for abnormal toxicity
 Parentral in doses of 10 ml or more should be tested for
freedom from Pyrogens
 Separate lab. for culture & manipulation of spore
bearing Pathogens
 Test for sterility should be carried out.
SJTPC 46

47. Manufacture Of Sch-X drugs
Conditions:
 Accounts of all transactions regarding manuf. should
be maintained in serially.(Preserved for 5 years)
 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 packings not exceeding
 100 unit dose –Tablets/Capsules
 300 ml- Oral liquid
 5 ml - Injection
SJTPC 47

48. Loan License
 Definition:
A person(applicant) who does not have his
own arrangements(factory) for manufacture but
who wish to manufacturing facilities owned by
another licensee. Such licenses are called Loan
licenses.
Loan licenses are issued for:
1) Drugs other than specified in C/C1 & X.
2) Drugs specified in Schedule-C/C1
SJTPC 48

49. 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 of drugs other than
Schdule-C/C1 and X.
SJTPC 49

50. Penalties related to
Manufacture
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
Manuf. of drugs in contravention of a) Imprisonment up to 3 months &
the provisions Rs.500 fine
b) Imprisonment up to 6 months
& Rs.1000 fine on subsequent
conviction
SJTPC 50

51. 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
SJTPC 51

52. SALE
SJTPC 52

53. Sale of Drugs
 Classes of drugs prohibited to be sold
 Wholesale of biological (C/C1)
 Wholesale of other than those specified in C/C1
and X
SJTPC 53

54. Class of drug prohibited to sale
 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, Armed force.
 Physician’s samples
SJTPC 54

55. 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
SJTPC 55

56. whole sale from other than
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.
SJTPC 56

57. Labeling & Packaging
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.
SJTPC 57

58. For allopathy
 Label
SJTPC 58

59. For ayurvedic, siddha, unani
homoepathy and cosmetics
LABEL
SJTPC 59

60. Schedules to the act
 First schedule – Names of books under
Ayurvedic and Siddha systems
 Second schedule – Standard to be complied
with by imported drugs and by drugs
manufactured for sale, sold, stocked or exhibited
for sale or distribution
SJTPC 60

61. Schedules to the rules
TYPE CONTENT
“A” Performa for forms( Application, issue, renewal, etc.)
“B” Rates of fee for test or analysis by CDL or Govt. analysts
“C” List of Biological and special products (Injectable) applicable
to special provisions.
“C1” List of Biological and special products (nonparenteral)
applicable to special provisions.
“D” List of drugs that are exempted from provisions of import
“E1” List of poisonous substances under the Ayurvedic , Siddha and
Unani systems
“F” Provisions applicable to blood bank
SJTPC 61

62. Schedules to the rules
TYPE CONTENT
“F1” Special provision applicable to biological and special products, eg.
Bacterial and viral vaccines, sera from living animals, bacterial
origin diagnostic agents
“F2” Standards for surgical dressings
“F3” Standards for umbilical tapes
“FF” Standards for ophthalmic preparations
“G” List of substances required to be used under medical
supervision and labelled accordingly
“H” List of substances (prescription) that should be sold by retail only
on prescriptions of R.M.P.
SJTPC 62

63. Schedules to the rules
TYPE CONTENT
“J” List of diseases and ailments that drug should not claim to cure
“K” List of drugs that are exempted from certain provisions regarding
manufacture
“M” Requirements of manufacturing premises, GMP requirements of factory
premises, plants and equipments
“M1” Requirements of factory premises for manufacture of Homeopathic
medicines
“M2” Requirements of factory premises for manufacture of cosmetics
“M3” Requirements of factory premises for manufacture of medical devices
“N” List of equipment to run a Pharmacy
“O” Standards for disinfectant fluids
SJTPC 63

64. TYPE CONTENT
“P” Life period(expiry) of drugs
“Q” Coal tar colors permitted to be used in cosmetics
“R” Standards for mechanical contraceptives
“R1” Standards for medical devices
“S” Standards for cosmetics
“T” Requirements (GMP) of factory premises for Ayurvedic, Siddha,
Unani drugs
“U” Manufacturing and analytical records of drugs
SJTPC 64

65. Schedules to the rules
TYPE CONTENT
“U1” Manufacturing and analytical records of cosmetics
“V” Standards for patent or proprietary medicines
“W” List of drugs marketed under generic names-
Omitted
“X” List of narcotic drugs and psychotropic substances
“Y” Requirement and guidelines on clinical trials for import and
manufacture of new drugs
SJTPC 65

66. Drugs and Cosmetics (Amendment)
Act, 2008
Salient features of the Act:-
 Substantial enhancement in punishment
 Life imprisonment for offenders involved in
manufacture, sale and distribution of spurious
and adulterated drug likely to cause grievous
hurt
 Minimum punishment of seven years which
may extend to life imprisonment
 Provision for compensation to affected person
SJTPC 66

67. Different types of forms
 Forms.
SJTPC 67

68. QUESTIONS
 Describe the functions of Central Drug Laboratory.
 Sale of drugs according to Drugs and Cosmetic Act.
 Describe the administration of Drug and cosmetics act
 Manufacture of drugs according to Drugs and
Cosmetics Act.
SJTPC 68

69. References
 www.cdsco.nic.in
 “Pharmaceutical Jurisprudence”, Jani GK, Atul
prakashan; Fifth edition(2005-06); 28.
 “Forensic Pharmacy”, Kokate CK and Gokhle
SB, Pharma Book Syndicate; 152
 “Laboratories” http://www.gujhealth.gov.in/fdc-
laboratory.htm
SJTPC 69

70. SJTPC 70