2. Contents
SJTPC 2
History and Objectives
Definitions
Administration of the act and rules
Provisions related toImport
Provisions related toManufacture
Provisions related toSale
Labeling and Packaging
Schedules to the act and rules
Recent amendmentact, 2008
List of forms
3. History
British misrule-Providing poor healthcare system to
Indian citizens
Observations made by-Drugs Enquiry
Committee, Indian MedicalAssociation
Reports in- Indian Medical Gazette during 1920-30
1940 – Drugs and CosmeticsAct
1945 – Rules under theAct
3
Extended to whole of India……
4. LISTOF AMENDING ACTS AND
ADAPTATION ORDERS
SJTPC 4
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
5. Objectives
SJTPC 5
To regulate the import, manufacture, distribution
and sale of drugs &cosmetics through licensing.
drugs and
Manufacture, distribution and sale of
cosmetics by qualified persons only.
To prevent substandard indrugs.
To regulate the manufacture and
Ayurvedic, Siddha and Unani drugs.
sale of
Advisory
To establish
Board (DTAB)
Drugs Technical
and Drugs Consultative
Committees(DCC) for Allopathic and allied drugs
and cosmetics.
6. Definitions
SJTPC 6
Drugs :
All medicines for internal or external use of
human
intended
beings
to
or animals
be used
and all substances
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.
7. Cosmetic :
SJTPC 7
intended to
Any article
rubbed, poured, sprinkled or
otherwise
sprayed
applied
introduced into, or
or any part thereof
be
on, or
to, the
for
human body
cleansing, beautifying, promoting
attractiveness, or altering the appearance, and
includes any article intended for use as a
component ofcosmetic.
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
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prescribed
(b) if it is not labelled in the
manner.
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
or deleterious
part, of any poisonous
substance which may render the contents
9
injurious tS
o
JTPC
health.
10. Spurious drugs:
SJTPC 10
a name which
(a) if it is imported under
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
11. Manufacture :
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to any drug or cosmetic, it
In relation
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.
12. Patent or Proprietary medicine :
SJTPC 12
A drug which
prescription presented in
is a remedy or
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.
13. Administration of the act andrules
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A) Advisory :
1)Drugs Technical AdvisoryBoard-DTAB
2)Drugs Consultative Committee-D.C.C.
B) Analytical :
1)Central Drugs Laboratory - CDL
2)Drug Control Laboratory instates
3)Government Analysts
C) Executives :
1)Licensing authorities
2)Controlling authorities
3)Drug Inspectors
14. DrugsTechnical Advisory Board(DTAB)
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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
Research
Institute,
(v)Director of Indian V
eterinary
Institute, Izatnagar
(vi) President of Medical Council ofIndia
(vii) President of the Pharmacy Council of India
(viii)Director of Central Drug Research
Lucknow
15. Nominated:
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1) Two persons by theCentral Government.
2) One person by the Central Government from
the pharmaceutical industry
3) Two persons holding the appointment of
Government Analyst under this Act,
16. Elected:
1)one person, to be elected by the Executive Committee of
the Pharmacy Council of India,
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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 MedicalAssociation;
5)one person to be elected by the Council of the Indian
Pharmaceutical Association;
17. Functions:
SJTPC 17
To advise the Central Government and the
State Governments on technical matters.
To carry out the other functions assigned to it by
this Act.
18. DrugsConsultative Committee(DCC)
SJTPC 18
It is also an advisory body constituted by central
government.
of the Central
of each State
Constitution:
Two representatives
Government
One representative
Government
19. Functions:
SJTPC 19
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 thisAct.
The Drugs Consultative Committee shall meet
when required
Has power to regulate its own procedure.
20. Central DrugLaboratory(CDL)
SJTPC 20
Established in Calcutta, under the control of a director
appointed by theCentral 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.
21. Drug control laboratories instate
SJTPC 21
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
23. Government analyst
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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 governmentanalyst.
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 forwardreports to the Government
givingthe result of analytical work and
research with a view to their publication.
SJTPC 24
25. Licencing authority
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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 .
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 arebeingobserved;
(3)to procure andsend for test or
analysis, if necessary, imported
packages.
(4) to investigate any complaint.
SJTPC 26
27. (5)to maintain arecordof all inspections made and
action taken by him in the performance of his
duties,
(6)to make such enquiries andinspections as maybe
necessary to detect the sale of drugs in
contravention to the Act;
SJTPC 27
28. Controlling authority
SJTPC 28
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 periodof five years:
29. DrugInspector
SJTPC 29
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 thispurpose.
30. Power:
SJTPC 30
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.
32. IMPORTofdrugs
SJTPC 32
Classes of drugs prohibited to import
Import of drug under license
1)Specified in Schedule-C/C1
2)Specified in Schedule-X
3)Imported forTest/Analysis
4)Imported for personal use
5)Any new drugs
Drugs exempted from provisions of import
Offences and Penalties
33. Classesof drugs prohibited to
import
SJTPC 33
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.
34. Import of thebiological
drugs(C/C1)
SJTPC 34
Conditions to befulfillled:
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 themarket.
35. Import of theSchedule-Xdrugs
(Narcotic & Psychotropicdrugs)
SJTPC 35
Conditions tobe fulfilled:
Licensee must have adequate storage facility.
Applicant must be reputable in the
occupation, trade orbusiness.
The license granted even before should not be
suspended orcancelled.
The licensee has not been convicted any
offence under the Drugs and Cosmetics Act or
Narcotic and Psychotropic Substances Act.
36. DrugsImported for
examination, test or analysis
Conditions to befulfilled:
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.
37
Must allow an inspector to inspect the premises
and check tS
h
JTe
PC records.
37. Drugsimported for personaluse
SJTPC 37
Conditions tobe 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 formno.-12-A,12-B
custom
Drugs must be bonafide personal use.
Drugs must be declared to the
collectors if so directed.
38. Import of drugs withoutlicense
SJTPC 38
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
39. Penalties related to Import
OFFENCES PENALTIES
Import of spurious OR
adulterated drug OR drug which
involves risk to human beings or
animals OR drug not having
therapeutic values
a) 3 years imprisonment and
5000 Rs. fine on first
conviction
b) 5 years imprisonment OR
1000 Rs. fine OR both for
subsequent conviction
Contravention of the provision
SJTPC
a) 6 months imprisonment OR
500 Rs. fine OR both for first
conviction
b) 1year imprisonment OR 1000
Rs. fine for subsequent
offence
40
40. Cosmetics prohibited to import
40
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 heavymetals
42. Manufacture
SJTPC 42
Prohibition of manufacture
Manufacture of other than in Sch-C/C1
Manufacture of those in Sch-C/C1
Manufacture of Sch-Xdrugs
Loan license
Repackaging license
Offences &Penalties
43. Prohibition of manufacture
Drug not of standard quality or misbranded,
adulterated orspurious.
SJTPC 43
Patent orProprietary medicine
Drugs in Sch-J
Risky to human beings or animals
Drugs without therapeutic value
Preparation containing cyclamates
44. Manuf. of drugs other than inSch-
C/C1
SJTPC 44
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 ofstability
Maintain the inspection book
Maintain reference samples from each batch
45. Manuf. of drugs those inSchedule-
C/C1(Biological)
SJTPC 45
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, Pituitaryhormones.
Serum tested for abnormal toxicity
Parentral in doses of 10ml or more should be tested for
freedom from Pyrogens
of spore
Separate lab. for culture & manipulation
bearing Pathogens
Test for sterility should be carried out.
46. Manufacture Of Sch-Xdrugs
SJTPC 46
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
47. LoanLicense
SJTPC 47
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 issuedfor:
1)Drugs other than specified inC/C1 &X.
2) Drugs specified in Schedule-C/C1
48. Repackaginglicense
SJTPC 48
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.
49. 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 adulterateddrugs a) 1 year imprisonment & Rs.2000
fine
b) 2 years imprisonment &
Rs.2000 fine for subsequent
conviction
Manuf. of drugs in contraventionof
the provisions
a) Imprisonment up to 3 months &
Rs.500 fine
b) Imprisonment up to 6 months
& Rs.1000 fine on subsequent
conviction
SJTPC 49
50. Manufacture of cosmetics
SJTPC 50
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 oflead
- 100 ppm of heavy metals
Eye preparations containing coal-tar color
52. Saleof Drugs
SJTPC 52
Classes of drugs prohibited to be sold
Wholesale of biological (C/C1)
Wholesale of other than those specified in C/C1
and X
53. Classof drug prohibited to sale
SJTPC 53
Misbranded, spurious, adulterated and drugs not
of standard quality
Patent/Proprietary drugs with undisclosed formula
Sch-J drugs
Expired drugs.
by government
Drugs used for consumption
schemes such as, Armed force.
Physician’s samples
54. Wholesale of biological(C/C1)
SJTPC 54
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 whois Reg. Pharmacist.
Records of purchase &sale
Records preserved for 3 years from date of sale
License should displayed on premises
55. whole sale from otherthan
specified in c/c1 andx
SJTPC 55
All the conditions as discussed in for biological.
Compounding is made by or under the direct and
personal supervision of a qualified person.
56. Labeling & Packaging
All the
labeling
general and specific
and packaging
specified to all classes of drugs
and cosmetics should be as per
the provisions made under the
act.
SJTPC 56
57. Schedules to the act
SJTPC 57
under
First schedule – Names of books
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
58. Schedules to the rules
SJTPC 58
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 specialprovisions.
“C1” List of Biological and special products (nonparenteral)
applicable tospecial 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
59. Schedules to the rules
SJTPC 59
TYPE CONTENT
“F1” Special provision applicable to biological and special products, eg.
Bacterial and viral vaccines, sera from living animals, bacterial
origin diagnosticagents
“F2” Standards for surgicaldressings
“F3” Standards for umbilicaltapes
“FF” Standards for ophthalmicpreparations
“G” List of substances required to be used under medical
supervision andlabelled accordingly
“H” List of substances (prescription) that should be sold by retail only
on prescriptionsof R.M.P.
60. 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 andequipments
“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
61. TYPE CONTENT
“P” Life period(expiry) ofdrugs
“Q” Coal tar colors permitted to be used in cosmetics
“R” Standards for mechanicalcontraceptives
“R1” Standards for medicaldevices
“S” Standards forcosmetics
“T” Requirements (GMP) of factory premises for Ayurvedic, Siddha,
Unani drugs
“U” Manufacturing and analytical records of drugs
SJTPC 61
62. Schedules to the rules
SJTPC 62
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 newdrugs
63. Drugs and Cosmetics(Amendment)
Act, 2008
SJTPC 63
Salient features of theAct:-
Substantial enhancement inpunishment
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 tolife imprisonment
Provision for compensation to affected person
