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
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……
3
4. LIST OF AMENDING ACTS AND ADAPTATION
ORDERS-------- (correct, improve)
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
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.
5
6. Definitions
Drug
Cosmetics
Misbranded Drug
Adulterated Drug
Spurious Drug
Manufacture
6
7. 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 (suppression) 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
8. Such substance (other than food) intended to affect
the structure or any other function of the human body
or intended to be used for destruction of vermin or
insects which cause disease in the human beings or
animals.
All the substances intended for use as components of
drug including empty gelatin capsule and,
Such devices intended for internal or external use in
diagnosis, treatment, mitigation or prevention of
disease or disorder in human beings or animals.
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
thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance, and
includes any article intended for use as a
component of cosmetic.
9
10. 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.
10
11. Adulterated drug :
(a) if it consists, in whole or in part, of any filthy,
putrid (dirty) 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. 11
12. If it bears or contains, a colour other than prescribed
which may be used for the purpose of colouring only
or
If any subsatance mixed with it so as to reduce its
quality or strength.
12
13. Spurious drugs : (fake)
(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
c) If the label or container of which bears the name
of an individual or company purporting to be the
manufacturing of drug, which individual or
company is fictitious or does not exists.
13
14. Manufacture :
In relation to any drug or cosmetic, it
includes any process or part of a process for
making, altering, ornamenting, finishing,
packing, 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.
14
15. 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.
15
16. Ayurvedic, Siddha or Unani Drug
I t includes all medicine intended for internal or
external use for, or in the diagnosis, treatment,
mitigation or prevention of disease or disorder in
human beings or animals and manufactured in
accordance with the formula describe in the
authoritative books of Ayurvedic, Siddha or Unani
system of medicine.
16
17. New Drug
a) a new substance of chemical, biological or
biotechnological origin; in bulk or prepared dosage
form; used for prevention, diagnosis, or treatment of
disease in man or animal; which, except during local
clinical trials, has not been used in the country to any
significant extent; and which, except during local
clinical trials, has not been recognized in the country
as effective and safe for the proposed claims;
(b) a drug already approved by the licensing authority
mentioned in certain claims, which is now proposed to
be marketed with modified or new claims, namely,
indications, dosage forms (including sustained release
dosage form) and route of administration;
17
18. (c) A fixed dose combination of two or more drugs,
individually approved earlier for certain claims, which
are now proposed to be combined for the first time in a
fixed ratio, or if the ratio of ingredients in an already
marketed combination is proposed to be changed,
with certain claims, viz. indications, dosage form
(including sustained release dosage form) and route of
administration
18
19. ADMINISTRATIVE BODIES
The central government and state government
establish or appoint following bodies for efficient
running of the act.
19
20. 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
20
21. Under the provision of the act the central Government
appoints the drugs Technical Advisory Board to advice
the central and state Government on technical
matters arising out of the administration of this act,
and to carry out the other function assigned to it by
this act.
21
22. Drugs Technical Advisory Board(DTAB)- The
board consisting of the following members.
Ex-Officio – members
(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
22
23. 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,
23
24. 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;
24
25. 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.
25
26. Drugs Consultative Committee(DCC)
It is also an advisory body constituted by central
government.-
to advice the central and state governments and the Drug
Technical Advisory Board on any matter to secure
uniformity throughout India in the administration of this
act.
Constitution:
Two representatives of the Central Government
nominated by central government
One representative of each State Government
nominated by concerned Government
26
27. There is separate ‘ The ayurvedic, siddha and unani
drugs consultative committee constituted under the
act.
27
28. 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.
28
29. Central Drug Laboratory(CDL)
The central government Establishes a central drug laboratory
(calcutta) under the control of Director.
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.
29
30. 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,
The functions of the Director in respect of the said drugs or
classes of drugs shall be exercised by the Director of the
said
Institute :___
(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
30
31. 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) Enterovirus Research Centre (Indian Council of
Medical Research), Haffkin Institute Compound, Parel,
Bombay-400012.]
[(c) The National Institute of Biologicals, NOIDA.]
31
32. 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
32
33. 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
33
34. The functions of the Laboratory in respect of
Homoeopathy shall be carried out at the
Homoeopathy Pharmacopoeia Laboratory, Ghaziabad.
34
35. The functions of the Laboratory in respect of Blood
Grouping reagent and diagnostic kits for Human
Immunodeficiency Virus, Hepatitis B Surface Antigen
and Hepatitis C Virus shall be carried out at the
National Institute of Biologicals, NOIDA.
35
36. Dispatch of samples for test or
analysis.
(1) Samples for test or analysis under subsection (4) of
Section 25 of the Act shall be sent by registered post in a
sealed packet, enclosed, together with a memorandum
in Form 1, in an outer cover addressed to the Director.
(2)The packet as well as the outer cover, shall be marked
with a distinguishing number.
(3)A copy of the memorandum in Form 1 and a specimen
impression of the seal used to seal the packet shall be
sent separately by registered post to the Director.
36
37. Recording of condition of seals.
On receipt of the packet, it shall be opened by an
officer authorized in writing in that behalf by the
Director who shall record the condition of the seal on
the packet.
37
38. Report of result of test or analysis. __ After test or
analysis the result of the test or analysis, together with
full protocols of the tests applied, shall be supplied
forthwith to the sender in Form 2.
Fees. __ The fees for test and analysis shall be those
specified in Schedule B.
Signature of certificates. __ Certificates issued under
these Rules by the Laboratory shall be signed by the
Director or by an officer authorized by the Central
Government by notification in the official Gazette to
sign such certificates.
38
39. Drug control laboratories in state
In Gujarat three laboratories established which collect,
analyzed 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
39
40. Function:
Testing of drug sample
Analysis of food sample
Analysis of excise sample
40
41. 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 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.
41
42. 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 3years 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.
42
43. 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
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.
43
44. 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 .
44
45. 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.
45
46. (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;
46
47. 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.
47
48. 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.
48
49. 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.
49
50. 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-
50
51. 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.
51
52. Qualification of a Licensing
Authority
No person shall be qualified to be a Licensing
Authority under the Act unless:--
(i) he is a 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) he has experience in the manufacture or testing of
drugs or enforcement of the provisions of the Act for a
minimum period of five years:
52
53. Controlling authority
authority.__(1) All Inspectors appointed by the Central
Government shall be under the control of an officer
appointed in this behalf by the Central government
and State Government
(2) For the purposes of these rules an officer appointed
by the Central Government under sub-rule (1), or as
the case may be, an officer appointed by the State
Government under sub-rule (2), shall be a controlling
authority.
53
54. 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.
54
55. 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.
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.
55
56. 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.
56
57. 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) upto 3
year or with fine or with both.
57
58. Provision
of Act
Import
Manufacturi
ng
Sales Labeling
&
Packaging
58
60. For the purpose of import, which is deemed to be the process of a
bringing a material from a place outside India to a place in India, a
drug are classified below:
A) Drug whose import is prohibited
B) Drug which may be imported under license or permit
C) Drug which can be imported without license
60
61. 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
61
62. A) 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.
62
63. B) Drug which may be imported under license or
permit
UNDER LICENCE/PERMIT
schedule C/C1 Drugs
Schedule-X drugs
Drugs Imported for examination, test or analysis
Without license
63
64. 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.
64
65. 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.
65
66. 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.
66
67. 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.(articles)
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.
67
68. Import of drugs without license
Substances not used for medicinal purpose
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
68
69. 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 a) 6 months imprisonment OR
500 Rs. fine OR both for first
conviction
b) 1 year imprisonment OR 1000
Rs. fine for subsequent
offence
69
70. 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
70
72. Manufacture --------- ?
Manufacture of drug is a totally controlled process
and drug can be manufactured and under license
subject to following :
i) Infrastructure facilities
ii) Technical Manpower
iii) Analytical Labrotaries
iv) Records
v) Inspection and sampling of drug
72
73. Manufacture
Kind of License – For the manufacturing of drugs
the following categories of licenses can be granted.
Licence for
Manufacture of Sch-C and C1 drug
Manufacture of Sch-X drugs
Manufacture of other than in Sch X and Sch-C/C1
Loan license
Drug meant for examination , test or analysis
Repackaging license
73
74. 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.
74
75. 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.
Marketed in packings not exceeding
100 unit dose –Tablets/Capsules
300 ml- Oral liquid
5 ml - Injection
75
76. 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
76
77. 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
77
78. Drug meant for examination , test
or analysis
Adequate space , well lighted and ventilated or if the need
be air-conditioned should be provided commensurate with
the nature and number of samples
Where animals are used for testing an adequate well
lighted and ventilated animal house should be provided
and the animal housed hygienically, proper arrangement
should be made for quarantining and periodic examination
of animals and preparation of animal feeds.
In general, compliance with the provision of the prevention
of cruelty of animals should be ensured
78
79. The test should be done by or under the supervision
of qualified and experience person
Books of standards and reference literature needed for
testing and analysis should be provided.
Adequate facilities should be provided for proper
storage of samples.
Record of analysis should be maintained for at least 2
years for drugs with expiry dates and at least for 6 yr
for other.
Report of analysis should be furnished in prescribed
form.
79
80. 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.
80
81. 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(artificial
sweetener )
81
82. 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
the provisions
a) Imprisonment up to 3 months &
Rs.500 fine
b) Imprisonment up to 6 months
& Rs.1000 fine on subsequent
conviction
82
83. 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
83
85. 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
85
86. 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
86
87. 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
87
88. 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.
88
89. 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.
89
90. Labelling
Name of drug
Net content
Content of API
Name & address of the manufacturing
Batch no.
License no.
Date of mfg
Date Exp
% Alcohol
90
94. 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
94
95. 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
95
96. 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.
96
97. Schedules to the rules
TYPE CONTENT
“J” List of diseases and ailments that drug should not claimto 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
97
98. 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
98
99. 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
99
100. 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
100