DRUGS CONTROL

ADMINISTRATION,A.P.
(Aims and Objectives)
Health is a Fundamental Right granted by
the Constitution of India.
The Drugs Control Administration aims at
assuring the availability of drugs &
Cosmetics of proven quality, efficacy and
safety at prices as announced. In addition,
it also guards the public from the
exploitation of misleading advertisements .
 DRUGS CONTROL
ADMINISTRATION, A.P. enforces
 Drugs & Cosmetics Act 1940 and Rules 1945,
 Drugs & Magic Remedies (OA) Act 1954 and
Rules 1955,
 Drugs (prices Control) Order 1995 (an Order made
u.s. 3 of Essential Commodities Act 1955),
 Narcotic Drugs & Psychotropic Substances Act
1985 and A.P. N.D&P.S. Rules 1986,
 Cigarettes & Other Tobacco products (prohibition of advertisements
and Regulation of Trade & Commerce, production, supply and
Distribution) Act, 2003
 Act & Rules.
The Drugs and Cosmetics Act 1940
&
The Drugs and Cosmetics Rules
1945
(as amended from time to time)
 Drugs & Cosmetics Act 1940 and Rules
1945
Drugs Act 1940 as amended by
Amendment Act 11 of 1955,
Amendment Act 35 of 1960,
Amendment Act 21 of 1962,
Amendment Act 13 of 1964,
Amendment Act 19 of 1972,
Amendment Act 68 of 1982,
Amendment Act 71 of 1986,
Amendment Act 26 of 2008 and
The Drugs & Cosmetic Rules 1945 as amended from time to time

Regulate the import, manufacture and sale or distribution of drugs and

cosmetics through Licenses and permits etc.,
Licences / Permits to Regulate
IS AN AUTHORISATION GRANTED BY A
STATUTORY AUTHORITY EMPOWERED
UNDER A STATUTE FOR CONDUCTING AN
ACTIVITY, THE ABSENCE OF WHICH
CONSTITUTES A VIOLATION / OFFENCE
PUNISHABLE UNDER THE LAW FOR THE
TIME BEING IN FORCE.
 SCHEME OF THE ACT
and RULES
 THE ACT ------ SIX CHAPTERS.
 Chapter I:-PRELIMINARIES
&DEFINITIONS
 Chapter II:- CDL,DCC,DTAB
 Chapter III:-IMPORT OF DRUGS & cosmetics
 Chapter IV:-MANUFACTURE and SALE
OF DRUGS AND COSMETICS
 Chapter IV A:-AYURVEDIC DRUGS
 Chapter V:- MISCILANEOUS.
 DRUG defined
(an inclusive definition)
(i) 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;

(ii) such substances (other than food) intended to affect the

structure or any function of human body or intended to be used
for the destruction of vermin or insects which cause disease in
human beings or animals, as may be specified from time to time by
the Central Government by notification in the Official Gazette;
(iii) all substances intended for use as components of a drug including
empty gelatin capsules; and

(iv) such devices intended for internal or external use in the diagnosis,
treatment, mitigation or prevention of disease or disorder in human
beings or animals, as may be specified from time to time by the
Central Government by notification in the Official Gazette after
consultation with the Board.
 DEVICE
(Draft Bill 2006)

 Device: an instrument, apparatus, implement, machine,

contrivance, implant, in vitro reagent, or other similar or related
article, including any component, part, or accessory, which is:
(1) recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or

in the cure, mitigation, treatment, or prevention of disease, in man
or other animals, or
(3) intended to affect the structure or any function of the body of man
or other animals, and which does not achieve its primary intended
purposes through chemical action within or on the body of man or
other animals and which is not dependent upon being metabolized
for the achievement of its primary intended purposes.
 Cosmetic
 “Cosmetic” means 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
 Manufacture,
 “manufacture” in relation to any drug or
cosmetic 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; and “to manufacture” shall be
construed accordingly;
 THE CENTRAL DRUGS LABORATORY,
Calcutta.
 To analyse or test such samples of drugs as
may be sent to it under sub-section (2) of
Section 11, or under sub-section (4) of Section
25 of the Act;
 To carry out such other duties as may be
entrusted to it by the Central Government
or, with the permission of the Central
Government, by a State Government after
consultation with the Drugs Technical Advisory
Board. Contd.,
Other laboratories with the status of CENTRAL
DRUGS LABORATORY
 1. Central Research Institute, Kasauli
 2. Pasteur Institute of India, Coonoor.
 3. Enterovirus Research Centre (Indian Council of Medical
Research), Haffkin Institute Compound, Parel, Bombay-
 4. The National Institute of Biologicals, NOIDA.
 5. The Indian Veterinary Research Institute, Izatnagar or
Mukteshwar
 6. Central Indian Pharmacopoeia Laboratory, Ghaziabad,
 7. Laboratory of the Serologist and Chemical Examiner to the
Government of India, Calcutta
 8. Central Drug Testing Laboratory, Thane, Maharashtra
contd.,
 Other laboratories with the status of
CENTRAL DRUGS LABORATORY
 9. National Institutes of Communicable Disease, Department of
Microbiology, Delhi.
 10. National Institute of Virology, Pune
 11. Centre of Advanced Research in Virology, Christian Medical
College, Vellore.
 12. Homoeopathy Pharmacopoeia Laboratory, Ghaziabad
 13.The National Institute of Biologicals, NOIDA

 NOTE:-
The Directors of these laboratories shall also exercise the functions
in respect of the notified drugs.
 The Drugs Technical Advisory
Board.
 to advise the Central Government and the State
Governments on technical matters arising out of
the administration of this Act and to carry out
the other functions assigned to it by this Act.

 consists of ex officio members, nominated

members, and elected members,
 Make bye-laws,
 constitute sub-committees
 Central Government shall appoint a secretary
The Drugs Consultative Committee
 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.
 consist of two representatives of the Central
Government to be nominated by that Government and
one representative of each State Government to be
nominated by the State Government concerned
 shall meet as and when required and shall
have power to regulate its own procedure
 Import of Drugs & Cosmetics
To import, with its grammatical variations
and cognate expressions means to bring
into INDIA.

Part IV of D&C Rules 1945 had under gone

significant major changes vide Notification
No.G.S.R.604(E) dated 24.8.2001 in respect of
IMPORT & REGISTRATION
 Prohibition of import of certain
drugs or cosmetics.
 any drug or cosmetic which is not of standard quality;
misbranded ,spurious or adulterated misbranded,
 any drug or cosmetic without an import licence
 any patent or proprietary medicine, unless labelled
as prescribed
 any drug with prohibitive claims
 any cosmetic containing any ingredient which is unsafe
or harmful
 any drug or cosmetic the import of which is prohibited
(small quantities are exempted by central government)
 Drugs may be imported.

For PERSONAL USE

For SALE or DISTRIBUTION
For Examination, Test/Analysis
For Treating patient By Government
Hospitals/ Autonomous Medical
Institutions
(Established or New-Drugs)
For conducting CLINICAL TRIALS
For USE IN MANUFACTURE OF FORMULATIONS.
 IMPORT LICENSES

THOSE SPECIFIED in schedule X

For Examination, Test or Analysis.
Govt. Hospital / Autonomous Medical institute for treatment of a
patient.
Small quantities of drugs for personal use. (not more than 100 doses.)
Small quantities of New drugs by Govt. Hospital / Autonomous
Medical institute for treatment of a patient.
Application for grant of permission to import or manufacture a new
drug or to under –take clinical trials.
Application for grant of permission to import or manufacture a new
drug or to under –take clinical trials. ----- Bulk Drugs.
 PRODUCT REGISTRATION
(For Import of DRUGS into INDIA)
 Application in Form ---- 40.
 Certificate in Form ---- 41.( valid for Three Years.)
 Over seas Manufacturer with whole-sale license in
India or by his authorised agent -- manufacturer or
wholesaler ---Shall Apply.
 Information & undertaking --- D. I & D.II
 Fee – Registration. . …………1,500 U.S dollars
Single product …………1,000 U.S dollars
Additional product…….. 1,000 U.S dollars
Inspection / visit ……….5,000 U.S dollars
Duplicate copy ……… 300 U.S dollars
 IMPORT
licences / permits.
 Licence to import drugs (excl., Schedule- X)- -Form 10.
 Licence to import Schedule X drugs- - - - - - - Form 10A.
 Licence to import drugs
for Examination, Test or Analysis – Form12.
 Licence to import drugs by Govt., Hospitals /Autonomous
Medical Institutions for treatment of patient- - Form
12A.
 Permit to import small quantities for personal use not
exceeding 100 doses - - - - - - - - - - - - - Form 12A.
 Licence to import NEW drugs by Govt., Hospitals
/Autonomous Medical Institutions for treatment of
patient Form - - - 12AA
 “Standards of Quality”

 (a) in relation to a drug,

that the drug complies with the standards set
out in the Second Schedule,
and
 (b) in relation to a cosmetic, that the cosmetic
complies with such standard as may be
prescribed. (Schedule “S” of the D&C Rules)
 The one which does not meet the prescribed
standards is Not of Standard Quality.
 Misbranded drugs.

a drug shall be deemed to be misbranded

 (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 claim for the drug or which is false or
misleading in any particular.
 Adulterated drugs.
(deemed to be)
 (a) if it consists, in whole or in part, of any filthy, putrid or
decomposed substance; or
 (b) if it has been prepared, packed or stored under insanitary
conditions whereby it may have been contaminated with filth
or whereby it may have been rendered injurious to health; or
 (c) if its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the
contents injurious to health; or
 (d) if it bears or contains, for the purpose of colouring only, a colour
other than the 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.
 Spurious drugs
a drug shall be deemed to be spurious
 (a) if it is manufactured under a name which belongs to another
drug; or
 (b) if it is an intimation of, or is 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 identity with such other
drug ; or
 (c) if the label or 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.
 Misbranded Cosmetics.
a cosmetic shall be deemed to be misbranded,
 (a) if it contains a colour which is not
prescribed; or
 (b) if it is not labelled in the prescribed manner;
or
 (c) if the label or container or anything
accompanying the cosmetic bears any
statement which is false or misleading in
any particular
 Spurious Cosmetics
(deemed to be)
 (a) if it is manufactured under a name which belongs to
another cosmetic; or
 (b) if it is an imitation of , or a substitute for , another
cosmetic or resembles another cosmetic in a manner
likely to deceive or bear upon it or upon its label or
container the name of another cosmetic unless it is
plainly and conspicuously marked so as to reveal its true
character and its lack of identity with such other
cosmetic; or
 (c) if the label or container bears the name of an
individual or a company purporting to be the
manufacturer of the cosmetic which individual or
company is fictitious or does not exist; or
 (d) if it purports to be the product of a manufacturer of
whom it is not truly a product.
 Adulterated cosmetics.
(deemed to be)
 (a) if it consists in whole or in part, of any filthy, putrid or
decomposed substance; or
 (b) if it has been prepared, packed or stored under insanitary
conditions whereby it may have been contaminated with filth or
whereby it may have been rendered injurious to health; or
 (c) if its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health; or
 (d) if it bears or contains, for purposes of colouring only, a colour
other than one which is prescribed; or
(e) if it contains any harmful or toxic substance which may render it
injurious to health; or
 (f) if any substance has been mixed therewith so as to reduce its
quality or strength.
Prohibition of manufacture and sale
of certain drugs and cosmetics….
 From such date as may be fixed by the State Government by
notification in the Official Gazette in this behalf, no person shall
himself or by any other person on his behalf—
 (a) manufacture for sale or for distribution ,or sell, or stock or
exhibit or offer for sale —
(i) any drug which is not of a standard quality, or is misbranded,
adulterated or spurious;
 (ii) any cosmetic which is not of a standard quality, or is
misbranded, adulterated or spurious;”.
 (iii) any patent or proprietary medicine, unless there is displayed in
the prescribed manner on the label or container thereof the true
formula or list of active ingredients contained in it together with the
quantities thereof;
 (iv) any drug which by means of any statement, design or device
accompanying it or by any other means ,purport or claims to
prevent ,cure or mitigate any such disease or ailment ,or to have
any such other effect as maybe prescribed; contd.,
Prohibition of manufacture and sale
of certain drugs and cosmetics.
 (v) any cosmetic containing any ingredient which may render it
unsafe or harmful for use under the directions indicated or
recommended;
 (vi) any drug or cosmetic in contravention of any of the provisions
of Chapter IV or any rule made thereunder;
 (b) sell, or stock or exhibit or offer for sale, or distribute any drug or
cosmetic which has been imported or manufactured in
contravention of any of the provisions of this Act or any rule made
thereunder;
 (c) manufacture for sale or for distribution, or sell, or stock or
exhibit or offer for sale, or distribute any drug or cosmetic ,except
under, and in accordance with the conditions of, a licence issued for
such purpose under this Chapter IV

Provided that nothing in this section shall apply to the manufacture,

subject to prescribed condition of small quantities of any drug for
the purpose of examination, test or analysis:
 DRUGS ACT IMPLIMENTATION IN ANDHRAPRADESH
STATE,
GAZETTE NOTIFICATION.
GAZETTE NO.31A.P.Gazette, Hyderabad Thursday, August 6th 1959
PART-I, DRUGS ACT:
Date on which Chapter IV of Drugs Act Shall come into force in ANDHRA PRADESH-
APPOINTED.
(G.O.M.S.No.1182,Health and Local Administration (Health) 21st May,1959
No.506,
In pursuanance of Sub-Section (3) of Section 1 of the Drugs Act, 1940 (Central Act XXIII
of 1940) and in supression of Notification No.142 of the Madras Government of
Composite State of Madras in so far it relates to the Andhra State published at page
48 of Part- I-A of Fort George Gazette, dated the 18th February, 1947, the Governor
of Andhra Pradesh appoints the date of publication of this notification in the ANDHRA
PRADESH GAZETTE as the date on which Chapter IV of the said Act shall take effect
in the State of A.P.
In pursuanance of Section of the Drugs Act, 1940 (Central Act XXIII of 1940) the
Governor of Andhra Pradesh hereby fixed the date of publication of this notification in
the ANDHRA PRADESH GAZETTE as the date for the purpose of the said Section.
Sd/- A.R.Gopalan
Deputy Secretary to Government
 Powers of Inspectors
 inspect any manufacturing or sales premises,
 take samples of any drug or cosmetic,
 at all reasonable times,
- search any person, enter and search any place, stop
and search any vehicle,
- examine any record, register, document or any other
material object,
- require any person to produce any record, register, or
other document,
- exercise such other powers as may be necessary for
carrying out the purposes of
Chapter IV or any rules made there under
 Procedure of Inspectors.
Taking Samples of drugs / cosmetics for
test or analysis
 Intimation – Form 17 and/or Form- 17A
 Three or four portions,
 One portion to be restored to the person,
 One portion to be sent to the G.A.
forthwith,
 One portion to be sent to the person who
was disclosed under section 18A,
 One portion to be deposited in the Court.
 1FORM 17
[See Rules 56 and 145-A]
Intimation to person from whom sample is taken
To…………………..

I have this day taken from the premises of.……………………..situated

at……………………………samples of the drugs / cosmetics specified
below for the purpose of test or analysis.

Date………………. Inspector……………….
Details of samples taken

Date………………. Inspector………………..
 FORM 17-A
(See Rules 56-A and 145-AA)

Receipt for samples of drugs or cosmetics taken where fair price tendered
thereof under subsection (I) of Section 23 of the Drugs and Cosmetics Act,
1940 is refused.
To ……………………..
……………………..
Whereas I, this ……… day of …….19 …….. have taken, from the premises of
situated
at …………… samples of drugs/cosmetics as specified below:-
Details of Samples …………..
And where I had offered to pay you rupees……………….. as the fair price of the
samples of drugs/cosmetics taken:
And whereas, you have refused to accept the fair price tendered thereof.
Now, therefore, I give you the receipt as the fair price tendered for the
samples of the drugs/cosmetics taken by me.
Date: ……………. Inspector …………….
 FORM 15
[See Rule 54 and 145 C]

Order under Section 22 (1)(c) of the Drugs and Cosmetics Act, 1940
requiring a person not to dispose of stock in this possession

Whereas, I have reasons to believe that the stocks of drugs / cosmetics

in your possession, detailed below contravene the provisions of section 18
of the Drugs and Cosmetics Act, 1940;
Now, therefore, I hereby require you under clause (c) of sub-section (1)
of section 22 of the said Act not to dispose of the said stock for a period of
………….days from the date of this order.
Date……………. Inspector……………….
Details of stock of drugs/ cosmetics

Date………………… Inspector……………….
 FORM 16
(See Rule 55 and 145-B)
Receipt for stock of drugs or cosmetics or for record, register
documents or material object seized under section 22 (1) (c) or (cc)
of the Drugs and Cosmetics Act, 1940.

The stock of drugs or cosmetics or records, registers, documents or material

objects detailed below has / have this day been seized by me under the
provisions of clause (c) or clause (cc) of sub-section (1) of section 22 of the
Drugs and Cosmetics Act. 1940 (23 of 1940) from the premises of
M/S……………………………situated at………………..

Date………………. Inspector……………….
Details of drugs, cosmetics, records, registers, documents or material object
seized

Date………………… Inspector………………...
 FORM 18
(See Rule 57)
Memorandum to Government Analyst
Serial No. of Memorandum…………………………………………………
From ……………

To
The Government Analyst ……………..
The portion of sample / container described below is sent herewith
for test or analysis under the provisions of clause (i) of sub-section
(4) of Section 23 of the Drugs and Cosmetics Act, 1940.
The portion of sample / container has been marked by me with the
following mark.

Details of portion of sample or container with name of drug/cosmetic

which it purports to contain—

Date……………. Inspector……….…….
 FORM 13
[See Rule 46]

Certificate of test or analysis by Government Analyst under Section 25

(1) of the Drugs and Cosmetics act, 1940

1. Name of Inspector from whom received……………

2. Serial No. and date of Inspector’s memorandum ………..
3. Number of sample…………………………
4. Date of receipt ………………
5. Name of drugs purporting to be contained in the sample ……….
6. Condition of seals on the [packet or on portion of sample or container ……….
7. Result of test or analysis with protocols of test or analysis applied …………
In the opinion of the undersigned the sample referred to above is of standard quality
as defined in the Drugs and Cosmetics Act, 1940. and Rules thereunder/
is not of standard quality as defined in the Drugs and Cosmetics Act 1940 and Rules
thereunder for the reasons given below:-

Date…………… Government Analyst…………..

 Reports of Government Analysts.
 The Government Analyst shall deliver to the Inspector
signed report in triplicate (in Form-13)
 The Inspector shall deliver
*one copy of the report to the person from
whom the sample was taken
*another copy to the person, if any, whose
name, address and other particulars have been
disclosed under section 18A, and
 *shall retain the third copy for use in any prosecution in
respect of the sample.
 Report signed by a Government Analyst under this
Chapter shall be evidence to the facts stated therein,
shall be conclusive unless notified within 28 days.
 Reports of Government Analysts
 Unless the sample has already been tested or analysed
in the Central Drugs Laboratory, where a person has
under sub-section (3) notified his intention of adducing
evidence in controversion of a Government Analyst’s
report, the Court may, of its own motion or in its
discretion at the request either of the complainant or the
accused, cause the sample of the drug 1[or cosmetic]
produced before the Magistrate under sub-section (4) of
section 23 to be sent for test or analysis to the said
Laboratory, which shall make the test or analysis and
report in writing signed by, or under the authority of, the
Director of the Central Drugs Laboratory the result
thereof, and such report shall be conclusive evidence of
the facts stated therein.
 The cost of a test or analysis made by the Central Drugs
Laboratory under subsection shall be paid by
complainant or accused as the Court shall direct.
 Power of Central Government to regulate or
restrict, manufacture, etc., of drug in
public interest.
 The Central Government may, by notification in the
Official Gazette, prohibit the manufacture, sale or
distribution of such drug or cosmetic
 +The Central Government may, by notification in the
Official Gazette, regulate or restrict the manufacture,
sale or distribution of such drug.”
+ (added be amendment Act 2008).
 Cognizance of offence
“(1) No prosecution under this Chapter shall be instituted
except by—
 (a) an Inspector; or
 (b) any gazetted officer of the Central Government or a
State Government authorised in writing in this behalf by
the Central Government or a State Government by a
general or special order made in this behalf by that
Government; or
(c) the person aggrieved; or
(d) a recognised consumer association whether such
person is a member of that association or not.
(2) No Court inferior to that of a Court of Session shall try
an offence punishable under this Chapter.”.
 Offences by companies.
 (1) Where an offence under this Act has been committed
by a company, every person who at the time the offence
was committed, was in charge of, and was responsible
to the company for the conduct of business of the
company, as well as the company shall be deemed to be
guilty of the offence and shall be liable to be proceeded
against and punished accordingly:

Provided that nothing contained in this sub-section shall

render any such person liable to any punishment
provided in this Act if he proves that the offence was
committed without his knowledge or that he exercised all
due diligence to prevent the commission of such offence.
contd.,
 Offences by companies contd.,
(2) Notwithstanding anything contained in sub-
section (1), where an offence under this Act has
been committed by a company and it is proved
that the offence has been committed with the
consent or connivance of, or is attributable to
any neglect on the part of, any director,
manager, secretary or other officer of the
company, such director, manager, secretary or
other officer shall also be deemed to be guilty of
that offence and shall be liable to be proceeded
against and punished accordingly:
 Penalties
S.No Penal Sections Penalties Penalties Fine Fine
& Nature Imprisonmen Imprisonment Act -1940
t Act 2008 Act -2008
Act 1940-

2. Section 27(b) Not less

[Violation of 17 A than1 year
Not less
than3 year
Not less
than Rs.
Not less than
Rs. 1 lakh or
or 17 c] 5,000/- 3x
(i) other → 3 years → 5 years (whichever is
adulterated more)
drugs
(ii) without
requisite valid
license
 Penalties
S.No Penal Sections Penalties Penalties Fine Fine
& Nature Imprisonment Imprisonment Act -1940 Act -2008
Act 1940- Act 2008

3. Section 27©
[Violation of 17B]
Not less
than3 years Not less
Not less
than Rs.
Not less
than
than 7 5,000/- Rs 3
Other spurious drug → 5 years years
lakhs
→ Life

4. Section 27(d)
any other drug in
Not less
than1 year
Not less
than1 year Fine
Not less
than Rs.
contravention of 20,000/-
away of the → 2 years → 2 years
provisions of
chapter-IV or any
rule made
 Penalties
S.No Penal Sections & Penalties Penalties Fine Fine
Nature Imprisonment Imprisonment Act -1940 Act -2008
Act 1940- Act 2008

5. Section 27(A)
[Violation of 17 D or 17 E]-
Not less than
3 years
Not less
than 3
Fine
Rs.
Not less than
Rs. 50,000/-
(i) Spurious / adulterated years 10,000 or 3 x
cosmetic → 1 year → 1 year (whichever is
(ii) any other cosmetic in high)
contravention of chapter IV
or any rule

6. Section 28
[Violation of 18 A or 24]
Not less than Not less Rs. Not less than

non disclosure of (i) the 1 year than 1 year 1000/- Rs 20,000/-

name & address of the
manufacturer etc.
(ii) the place where drugs /
cosmetics are being
manufactured d
 Penalties
S.No Penal Sections & Penalties Penalties Fine Fine
Nature Imprisonment Imprisonment Act -1940 Act -2008
Act 1940- Act 2008

7. Section 28
[Violation of 18 B]
Not less than Not less Rs. 1000/- Not less than
20,000/-
Failure to maintain & furnish 1 year than 1 year

records / registers

8. Section 28 B
[Violation of 26A]
Not less than Not less
3 years than 3
Rs. 5000/- Rs. 5000/-

Manufacture etc. of years

prohibited drugs / Cosmetics
 Penalties
S.No Penal Sections & Penalties Penalties Fine Fine
Nature Imprisonment Imprisonment Act -1940 Act -2008
Act 2008
Act 1940-

9. Section23 -Violation of 22
(c) (c) (a) (i)]
Not less
than 3
Not less than Fine
3 years
Fine

(i) obstructing the inspector years

(ii) refused to produce
records / registers
 Penalty for Subsequent offences
S.No Penal Sections & Penalties Penalties Fine Fine
Nature Imprisonment Imprisonment Act -1940 Act -2008
Act 1940- Act 2008

10. 30 (1) (a)

[Violation of 27(b)]
Not less than2
years
Not less
than7 years
Not less
than Rs.
Not less
than Rs.
→ 6 years → 10 years 10,000/- 2 lakhs

11. 30 (1) (b)

[Violation of 27(c)]
Not less than
6 years
Not less than
10 years
Not less
than Rs.
Not less
than Rs.
→ 10 years → Life 10,000/- 3 lakhs
 Penalty for Subsequent offences
S.No Penal Sections Penalties Penalties Fine Fine
Imprisonment Imprisonment Act -1940 Act -2008
& Nature
Act 1940- Act 2008

12 . 30 (1) (c) Not less than 2

years
Not less
than 2
Not less
than Rs.
Not less
than
[Violation of 27(d)]
→ 4 years years 5000/- 50,000/-
→ 4 years
or or or both or both

13. 30 (1A)
[Violation of 27(A)]
Not less than 2
years
Not less
than Rs.
2000/-
or
or both

→ 10 years
14. 30 (2)
[Violation of 29]
Not less
than 2
Fine
or both
Not less
than
years 10,000/-
or or both
 D & C RULES
 THE RULES ------- 19 PARTS.
 PART I – Preliminaries
 PART II – The Central Drugs Laboratory
 PART IV- Import and Registration
 PART V – Government Analysts,
Inspectors, Licensing Authority
and Controlling Authority
PART VI – Sale of Drugs other than Homeopathic
Medicines
PART VI A – Sale of Homeopathic Medicines
 D&C Rules contd.,
 PART VII – Manufacture for sale or for
Distribution of drugs other
than Homeopathic Medicines
 PART VII A- Manufacture for sale or for
Distribution of Homeopathic medicines
 PART VIII – Manufacture for Examination,

Test or Analysis
PART IX – Labeling & Packing of Drugs
other than Homeopathic Medicines
 D&C RULES contd.,
 PART IX A – Labelling & packing of
Homeopathic Medicines
 PART X – Provisions applicable to
BIOLOGICAL PRODUCT and
Other Special Products.
PART X A – Import or Manufacture of NEW DRUG for
CLINICAL TRIALS or
for MARKETING
PART X B – Provisions applicable to BLOOD-BANK and
BLOOD PRODUCTS.
PART XI – EXEMPTIONS
PART XII – STANDARDS
PART XIII – Import of cosmetics
PART XIV – Manufacture of Cosmetics for Sale or Distribution
PART XV – Labelling, Packing and Standards of Cosmetics
 D&C Rules. Contd.,
 PART XV(A) – Provisions applicable to
APPROVED
LABORATORIES
 PART XVI – Manufacture for sale of

AYRVEDIC DRUGS
PART XVI(A) –Provisions applicable to
APPROVED LABORATORIES
 D&C RULES contd.,
 PART XVII – Labelling, Packing and limit of
alcohol in Ayurvedic,
Siddha or Unani Drugs.
PART XVIII – Govt. analysts and Inspectors
for Ayurvedic, Siddha, or
Unani Drugs.
PART XIX – standards for Ayurvedic, Siddha
and Unani Drugs.
.
D&C RULES contd (sch A to Y)
 SCHEDULE – A - FORMS
 SCHDULE – B – Fee for Test or Analysis

 SCHEDULE- C –Biological &

Special Products
SCHEDULE – C1- Other Special Products
SCHEDULE- D –Exemptions u. c. III
SCHEDULE- D(I)- Information –Mfg. unit
Registration for import
 D&C RULES contd.,
 Schedule – D(II)-Information –product
Registration for import
 SCHEDULE- E(1) – Poisonous Substances
 SCHEDULE F – PART I to PART XII(A) OMITTED
 PART XII - B - Blood &Blood BANKS
 PART XII – C - BLOOD PRODUCTS.
 SCHEDULE F(1) – Bacterial Vaccines, Sera
 SCHEDULE F(II) - Standards, Surgical Dressings
 SCHEDULE F(III) – Standards Umbilical Tapes
 SCHEDULE FF – Standards Ophthalmic
preparations
,
 D&C RULES contd.,
SCHEDULE G – Drugs to be used under
the supervision of Regd.Medical
Practitioners.
SCHEDULE H – Prescription Drugs
SCHEDULE J – Prohibition on
advertisements on drugs.
SCHEDULE K – Exemptions-Chap IV
SCHEDULE L1 – Good Laboratory practices.
 D&C RULES contd.,
 SCHEDULE M – Good Mfg Practices
 SCHEDULE M-I –GMP Homeo Medicines
 SCHEDULE M II – Factory-cosmetics
 SCHEDULE M III -Factory medical Devices
 SCHEDULE N - Pharmacy- requirements
 SCHEDULE O – Standards for
Disinfectant fluids
 D&C RULES CONTD.,
 SCHEDULE P – Life Period of drugs
 SCHEDULE P 1 –Pack size of drugs
 SCHEDULE Q- Colours Cosmetics
SCHEDULE R- Standards for Condoms
 SCHEDULE R1-Stds for Medical Devices
 SCHEDULE S- Standards for cosmetics
 SCHEDULE T-GMP- Ayurvedic Drugs
 D&C RULES contd.,
 SCHEDULE U – RECORDS-DRUGS
 SCHEDULE U1- Records Cosmetics
 SCHEDULE V- Stds for P&P Medicines
 SCHEDULE X- Class of Drugs- XRx
 SCHEDULE Y- Requirements and Guide-
- lines for permission to
import and/or manufacture
of New Drugs
for sale or undertake Clinical Trials.
Thanks for your attention.

Questions / Comments ?

- D. Hanumantha Rao
040-23813040 (Res)
94408-97896 (Mobile)