The drugs and cosmetics act and rules cosmetics-mnz

THE DRUGS AND
COSMETICS ACT AND
RULES - COSMETICS
Maitreyi Zaveri,
KBIPER,
Gandhinagar

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……
Dr. Maitreyi N. Zaveri, KBIPER 2

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.Dr. Maitreyi N. Zaveri, KBIPER 3

The salient features of the Drugs & Cosmetics
Act, 1940 are as follows:
• a) Maximum penalty life imprisonment and fine
of Rs. 10 lakhs or 3 times the value of the goods,
whichever is more.
b) Some of the offences cognizable (within the
jurisdiction of a court) and non-bailable.
c) Besides officers from the Drug Controller’s
Office, other gazette officers also authorized to
launch prosecution under the Act;
d) Specially designated courts for trial of offences
covered under the Act;
e) Provision for compounding of minor offences.

SCHEME OF THE ACT and RULES
THE ACT ------ SIX CHAPTERS.
• Chapter I:-PRELIMINARIES &DEFINITIONS
• Chapter II:- DTAB, CDL,DCC, (The Drugs
Technical Advisory Board, The Central Drugs
Laboratory And The Drugs Consultative
Committee )
• Chapter III:-IMPORT OF DRUGS & cosmetics
• Chapter IV:-MANUFACTURE and SALE OF
DRUGS AND COSMETICS
• Chapter V A:-AYURVEDIC DRUGS
Chapter VI:- MISCILANEOUS.
5Dr. Maitreyi N. Zaveri, KBIPER

CHAPTER I - INTRODUCTORY
• “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.
6Dr. Maitreyi N. Zaveri, KBIPER

• “DRUG” includes—
• (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 (the action of reducing the
severity) 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 the
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;]

• 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.

AUTHORITIES FOR REGULATION OF COSMETICS
(CENTRAL DRUGS STANDARD CONTROL ORGANIZATION-
CDSCO )
The main authority for regulation is CDSCO.
18/7/2012 11

AGENCIES FOR REGULATION
18/7/2012 12Pharmaceutical Management &
Regulatory Affairs

Administration of the act & 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

• “GOVERNMENT ANALYST” means—
• (i) in relation to [Ayurvedic, Siddha or Unani]
drug, a Government Analyst appointed by the
Central Government or a State Government
under section 33F; and
• (ii) in relation to any other drug or cosmetic, a
Government Analyst appointed by the Central
Government or a State Government under
section 20.

• “INSPECTOR” means—
• (i) in relation to [Ayurvedic, Siddha or
Unani] drug, an Inspector appointed by the
Central Government or a State
Government under section 33G; and
• (ii) in relation to any other drug or
cosmetic, an Inspector appointed by the
Central Government or a State
Government under section 21;

• “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.

CHAPTER-II
• THE DRUGS TECHNICAL ADVISORY
BOARD
• THE CENTRAL DRUGS LABOURATORY
AND
• THE DRUGS CONSULTATIVE
COMMITTEE

THE DRUGS TECHNICAL ADVISORY
BOARD
• Constitutedby Central Government
• Constitution:18 members (8ex officio, 5nominated
5electedmembers)
• Ex officio
– Director general of healthservices, chairman
– Drugcontroller of India, secretary
– Director, central druglaboratory, Kolkatta
– Director, central researchinstitute, Kasauli
– Director, Indianveterinary researchinstitute, Izatnagar
– Director, central drugresearchinstitute, Lucknow
– President, pharmacy council of India
– President, medical council of India

• Nominated
• 2 persons nominated by Central Government
• 1 person from Pharmaceutical Industry
• 2 Government Analysts
• Elected
• 1 teacher from Pharmaceutical Chemistry or
Pharmacognosy of college or university
approved by Pharmacy Council of India.
• 1 teacher in medicine or therapeutics
Pharmacognosy of college or university
approved by Pharmacy Council of India.
• 1 Pharmacologist elected by ICMR
• 1 person elected by council IPA
• 1 person elected by central council of IMA

FUNCTIONS
• To advice the central government and state
governments on technical matters.
• Modifications and amendments in the D & C act
with consultation of board.

Central Drugs Laboratory (CDL)
•Location: Kolkata
•Controlled by a director appointed by
central government
•Functions
–Testing of Drug samples sent to it by the
Courts.
–Analysisof Foodsample
–Analysisof Excisesample

• Collection, storage and distribution of
international standards
• Maintenanceof microbial cultures
• Trainingof druganalysis
• Trainingof WHO fellows
• To advise the central drug control
administration in respect to quality and
toxicity.

THE CENTRAL DRUGS
LABORATORY (Kolkata)
• 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.

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

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 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

Indian Council of Medical Research
• Dr. V.M.Katoch is the present Director
General of IndianCouncil of Medical Research.
• The Board is assisted by a series of Scientific
Advisory Groups, Scientific Advidsory
Committees, Expert Groups, Task Forces, etc.
which evaluate and monitor different research
activitiesof theCouncil.Dr. Maitreyi N. Zaveri, KBIPER 27

Functions
• The Council promotes biomedical research in
the country through intramural as well as
extramural research.
• Intramural research is carried out currently
through the Council's 30 Permanent Research
Institutes/Centres.
• Extramural research is promoted by ICMR by
establishing Centres for Advanced Research in
selected departments of Medical Colleges,
Universities and other non-ICMR Research
Institutes. Dr. Maitreyi N. Zaveri, KBIPER 28

CENTRAL INDIAN
PHARMACOPOEIA LABORATORY
• ItislocatedinGHAZIABAD
• Theprojectinvolvescompleteautomationof
variousareasof DrugTesting.

These includes the following
systems:
Laboratory SamplesInformationSystem
Experimental AnimalsInformationSystem
Pharmacopoeial Information Management
System
StoreandInventory System
Personnel InformationSystem(PIS)
Payroll / GPF AccountingSystem
Bank ReconciliationSystem
LeavesAccountingSystemDr. Maitreyi N. Zaveri, KBIPER 30

Indian Veterinary
Research Institute
• Indian Veterinary Research Institute is
located at Izatnagar, Bareilly in Uttar Pradesh
state.
• It has campuses at Mukteshwar, Bangalore,
Palampur, Bhopal, KolkataandSrinagar.

• Formerly known as Imperial Bacteriological
Laboratory, it was renamed in 1925 as
Imperial Veterinary ResearchInstitute.
• Then to Indian Veterinary Research Institute
after independence.
• It is in control of President of Indian Council
of Agricultural Research(ICAR), New Delhi.

Functions
– To plan, undertake aid, promote and coordinate
education, researchanditsapplicationinagriculture,
agroforestry, fisheries, home science and allied
sciences.
– Developing cooperative programmes with other
organizations such as the Indian Council of Social
Sciences Research, Council of Scientific and
Industrial Research, Bhabha Atomic ResearchDr. Maitreyi N. Zaveri, KBIPER 33

Council of Scientific
& Industrial Research
• Chairman : Primeminister of india
• Director general : Prof. Samir K.
Brahmachari

• Council of Scientific and Industrial Research
(CSIR) establishedin1942
• India's largest Research and Development
(R&D) organization, with 39 laboratories and
50fieldstations.
• The research and development activities of
CSIR includes various fields such as aerospace
engineering, Structural engineering, ocean
sciences, molecular biology, metallurgy,
chemicals, mining, food, petroleum, leather,
andenvironment.

Department of Science
&Technology
Prof. Ashutosh Sharma is its present
secretary
It was established in May 1971, with the
objective of promoting new areas of Science
andTechnology
Plays the role of a nodal department for
organizing, coordinating and promoting
Scientific and Technological activities in the
country.

• It give funds to various approved scientific
projectsinIndia.
• It also supports various researchers in India to
attend conferences abroad and to go for
experimental works.
• It takes up large-scale science popularization
tasks/activities, to promote and propagate
scientific and rational outlook, to act as a
resource-cum-facility centre for S&T
communication.
• ItpublishesamagazineDream 2047Dr. Maitreyi N. Zaveri, KBIPER 37

Pharmacy Council of India
• The pharmacy education and profession in
India up to graduate level is regulated by the
Pharmacy Council of India (PCI), a body
governed by the provisions of the Pharmacy
Act1948passedby theIndianParliament

FUNCTIONS AND DUTIES
To prescribe minimum standard of education
requiredfor qualifyingasapharmacist.
Framing of Education Regulations prescribing
the conditions to be fulfilled by the institutions
seeking approval of the PCI for imparting
educationinpharmacy.
To ensure uniform implementation of the
educational standardsthroughoutthecountry.
Inspection of Pharmacy Institutions seeking
approval under the Pharmacy Act to verify
availability of theprescribednorms.Dr. Maitreyi N. Zaveri, KBIPER 39

To approve the course of study and
examination for pharmacists i.e. approval of
the academic training institutions providing
pharmacy courses.
To withdraw approval, if the approved course
of study or an approved examination does not
continue to be in conformity with the
educational standardsprescribedby thePCI.
To approve qualifications granted outside the
territories to which the Pharmacy Act extends
i.e. theapproval of foreignqualification.
TomaintainCentral Register of Pharmacists.Dr. Maitreyi N. Zaveri, KBIPER 40

Gujarat Food & Drug Control
Administration
• Dr. Hemant G. Koshia , M. Pharm is the
Commissioner of this Administration. He is
also holding thechargeof Joint Commissioner
(Drug) and Licensing & Controlling Authority
under Drug& CosmeticsAct& Rules

• As per the provisions of the Act, for the sale
drugs, every firm has to obtain necessary
licences from the Licensing Authority &
Assistant Commissioner of the respective
CircleOffice.
• The licensee firms are periodically inspected
by the Drugs Inspectors to ascertain that the
provisions of Drugs & Cosmetics Act are
beingobserved.
• If any contravention found during theDr. Maitreyi N. Zaveri, KBIPER 42

• The actions may vary from issuing warning,
suspensionor cancellationof licencesto filinga
complaint in the Court of Law depending upon
thenatureof thecontraventions.
• Sampling of various drugs & cosmetics from
the licensee firms is carried out by Drugs
Gujarat accounts for about 40% of
pharmaceutical production.
• Total 3507 manufacturing units engaged in
manufacturing of Allopathic, Ayurvedic,
Homeopethicdrugs& Cosmetics

CHAPTER III
IMPORT OF DRUGS
AND COSMETICS

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

Standards of quality
“standard quality” means—
• (a) in relation to a drug, that the drug
complies with the standard set out in [the
Second Schedule], and
• (b) in relation to a cosmetic, that the
cosmetic compiles with such standard as
may be prescribed.

Misbranded drugs
• (a) if it is so coloured, coated, powdered or
polished that damage is concealed or if it is
made to appear of better or greater therapeutic
value than it really is; or
• (b) if it is not labelled in the prescribed manner;
or
• (c) if its label or container or anything
accompanying the drug bears any statement,
design or device which makes any false claim
for the drug or which is false or misleading in
any particular.

Adulterated drugs
• (a) if it consists, in whole or in part, of any filthy,
putrid or decomposed substance; or
• (b) if it has been prepared, packed or stored
under insanitary conditions whereby it may have
been contaminated with filth or whereby it may
have been rendered injurious to health; or
• (c) if its container is composed in whole or in
part, of any poisonous or deleterious substance
which may render the contents injurious to
health; or

Adulterated drugs
• (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.

Spurious drugs.
• (a) if it is imported under a name which belongs
to another drug; or
• (b) if it is an imitation of, or a substitute for,
another drug or resembles another drug in a
manner likely to deceive or bears upon it or
upon its label or container the name of another
drug unless it is plainly and conspicuously
marked so as to reveal its true character and its
lack of identity with such other drug; or

Spurious drugs.
• (c) if the label or the container bears the name of
an individual or company purporting to be the
manufacturer of the drug, which individual or
company is fictitious or does not exist; or
• (d) if it has been substituted wholly or in part by
another drug or substance; or
• (e) if it purports to be the product of a
manufacturer of whom it is not truly a product.

Misbranded cosmetics
• a) if it contains a colour which is not prescribed;
or
• (b) if it is not labelled in a 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
• (a) if it is imported under the name which
belongs to another cosmetic; or
• (b) if it is an imitation of, or is a substitute for,
another cosmetic or resembles another cosmetic
in a manner likely to deceive or bears upon it or
upon its label or container the name of another
cosmetic, unless it is plainly or conspicuously
marked so as to reveal its true character and its
lack of identity with such other cosmetic; or

Spurious cosmetics
• (c) if the label or the container bears the name of
an individual or 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.

(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;
Regulatory Affairs
Adulterated cosmetics
(ADDED IN 2008 AMENDMENT)

(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;
(f) if any substance has been mixed therewith
so as to reduce its quality or strength.”
Regulatory Affairs

List of cosmetics as per Sch.S
Regulatory Affairs

Cont…
Regulatory Affairs

Prohibition of import of certain
drugs or cosmetics.
• From such date,
as may be fixed by the Central
Government by notification in the Official
Gazette in this behalf, no person shall import—
• (a) any drug [or cosmetic] which is not of
standard quality;
• (b) any misbranded drug [or misbranded or
spurious cosmetic , any adulterated or spurious
drug;
• (c) any drug [or cosmetic] for the import of which
a licence is prescribed, otherwise than under,
and in accordance with, such licence;
• ;] Dr. Maitreyi N. Zaveri, KBIPER 59

drugs or cosmetics.
• 4[(d) any patent or proprietary medicine, unless
there is displayed in the prescribed manner on
the label or container thereof 5[the true formula
or list of active ingredients contained in it,
together with the quantities thereof
• (e) any drug which by means of any statement,
design or device accompanying it or by any
other means, purports or claims to cure or
mitigate any such disease or ailment, or to have
any such other effect, as may be prescribed;

drugs or cosmetics.
• ee) any cosmetic containing any ingredient
which may render it unsafe or harmful for use
under the directions indicated or recommended;
• (f) any drug or cosmetic the import of which is
prohibited by rule made under this Chapter:
• Provided that nothing in this section shall apply
to the import, subject to prescribed conditions, of
small quantities of any drug for the purpose of
examination, test or analysis or for personal use:

drugs or cosmetics.
• Provided further that the Central Government
may, after consultation with the Board, by
notification in the Official Gazette, permit,
subject to any conditions specified in the
notification, the import of any drug or class of
drugs not being of standard quality.

CHAPTER IV
MANUFACTURE, SALE AND
DISTRIBUTION OF DRUGS
AND COSMETICS

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] or distribute—
– (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 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, purports or claims [to prevent, cure
or mitigate] any such disease or ailment, or to
have any such other effect as may be
prescribed;

• (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 this Chapter or any rule
made there under;
• (b) sell, or stock or exhibit or offer for saleor
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
there under;

• (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

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 underDr. Maitreyi N. Zaveri, KBIPER 68

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.Dr. Maitreyi N. Zaveri, KBIPER 69

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.
• 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.Dr. Maitreyi N. Zaveri, KBIPER 75

Offences by companies.
• (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:

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
• 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 – Labelling & Packing of Drugs
other than Homeopathic Medicines

D & C RULES
• 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

D & C RULES
• PART XIII – Import of cosmetics
• PART XIV – Manufacture of Cosmetics for
Sale or Distribution
• PART XV – Labelling, Packing and Standards
of Cosmetics
• 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
• PART XVII – Labelling, Packing and limit of
• alcohol in Ayurvedic, Siddha or Unani Drugs.
• PART XVIII – Govt. analysts and Inspectors for
Ayurvedic, Siddha, orUnani Drugs.
• PART XIX – standards for Ayurvedic, Siddha
• and Unani Drugs. .

(sch A to Y)

DRUG AND COSMETIC ACT
1940
(only schedules)
by RAHUL
challarahul77@gmail.com

FIRST SCHEDULE;
“Ayurvedic, Siddha or Unani drug” includes all medicines intended for
internal
or external use for or in the diagnosis, treatment, mitigation or prevention.
SECOND SCHEDULE. Standards of quality
standards to be complied with by imported drugs and by drugs
manufactured for sale, vold, stocked or exhibited for sale or distributed
SCHEDULE ‘E’. Poisonous substance
List of poisonous substances under the Ayurvedic (including Siddha) and
Unani Systems
SCHEDULE ‘B’
The fees for test and analysis shall be those specified in Schedule B.

SCHEDULE ‘X ‘: symbol XRX
“import licence” means a licence in Form 10A to import drugs ; excluding
those specified
SCHEDULE ‘C ‘OR ‘C ‘(1): Prohibition of import after expiry of
potency
No biological or other special product specified shall be imported after the
date shown on the label, wrapper or container of the drug as the date up to
which the drug may be expected to retain a potency not less than, or not to
acquire a toxicity greater than, that required, or as the case may be,
permitted by the prescribed test.
SCHEDULE ‘F’ (1) :standard for certain imported drugs
No drug shall be imported unless it complies with the standard of strength,
quality and purity

SCHEDULE ‘M’ AND SCHEDULE ‘M-III’
Every application in Form 24 shall be made up to ten items for each
category of drugs categorised in and shall be accompanied by a licence fee
of rupees six thousand and an inspection fee of one thousand and five
hundred for every inspection or for the purpose of renewal of the licence
SCHEDULE ‘U’.
lot of the raw material used by him for the manufacture of his products and
also each batch of the final product and shall maintain records.
The records or registers shall be retained for a period of 5 years from the
date of manufacture

SCHEDULE ‘F’
The licence shall provided and maintain an adequate staff and adequate
premises and plant for the proper manufacture and storage of the substances
in respect of which the licence is issued.
SCHEDULE ‘R’.
The date of manufacture.
The date up to which the contraceptive is expected to retain its properties.
The storage conditions necessary for preserving the properties of the
contraceptive up to the date indicated in sub-clause (b) .
SCHEDULE ‘G’ :LABELLING OF MEDICINES
labelled with the words ‘Caution: it is dangerous to take this preparation
except under medical supervision’ – conspicuously printed and surrounded
by a line within which there shall be no other words

SCHEDULE ‘H’ :LABELLING OF MEDICINES
Labelled with the symbol Rx and conspicuously displayed on the left top corner of
the label .
Labelled with the following words To be sold by retail on the prescription of a
Registered Medical Practitioner only.
SCHEDULE ‘P-1’: PACKING OF DRUGS
The pack sizes of drugs meant for retail sale shall be as prescribed.
Eg; The pack sizes for liquid Oral preparations shall be 30ml (paediatric only) 60
ml/100 ml/200 ml/450 ml.
SCHEDULE ‘Y’,
Provided further that any application received after one year of the grant of
approval for the import and sale of new drug.
A fee of fifteen thousand rupees and such information and data as required by
Appendix I or Appendix I-A.

SCHEDULE ‘A’
For the purpose of this rule, “Blood Bank” means a place or organizational unit
or an institution or other arrangement made by such organizational unit or
institution for carrying our all or any of the operations of manufacture of human
blood components, or blood products or whole human blood for its collection,
storage, processing, distribution from selected human donors.
SCHEDULE ‘K’; EXEMPTION
The drugs specified in shall be exempted from the provisions of Chapter IV of
the Act and the Rules made there under to the extent and subject to the
conditions specified in that Schedule.
SCHEDULE ‘V’; STANDARDS FOR PATENT OR
PROPRIETARY MEDICINES
The standards for patent or proprietary medicines shall be those laid down in
Schedule V and such medicines shall also comply with the standards laid down
in the Second Schedule to the Act.

SCHEDULE ‘F (II)’ ;Standards for Surgical Dressings
The standards for Surgical Dressing shall be such as are laid down
SCHEDULE ‘F(III)’ ;Standards for Sterilised Umbilical tapes
The standards for Sterilised Umbilical tapes shall be as laid down
SCHEDULE ‘R-1’.
Standards for Medical Devices.- the standards for the Medical Devices shall
be such as are laid down

SCHEDULE ‘D’; EXEMPTION OF COSMETICS
Cosmetics specified shall be exempted from the provisions of Chapter
III of the Act and the Rules made there under to the extent and subject
to the conditions specified .
SCHEDULE ‘Q’. COSMETIC TO CONTAIN DYES,
COLOURS AND PIGMENTS
No Cosmetic shall contain Dyes, Colours and Pigments other than those
specified by the Bureau of Indian Standards (IS:4707 Part 1 as
amended)
SCHEDULE ‘U(1)’
the licensee shall keep records of the details of each batch of cosmetic
manufactured by him and of raw materials used therein as per
particulars specified in Schedule U(1) and such records shall be
retained for a period of three years.

SCHEDULE ‘T’
For getting a certificate of ‘Good Manufacturing Practices' of Ayurveda Siddha-
Unani drugs, the applicant shall made application on plain paper, providing the
information on existing infrastructure of the manufacturing unit, and the
licensing authority shall after verification of the requirements as per Schedule
‘T’ issue the certificate within a period of 3 months in form 26-E
SCHEDULE ‘E’ (1),
The container of a medicine for internal use made up ready for the treatment of
human ailments shall, if it is made up from a substance specified in Schedule E
(1), be labelled conspicuously with the words ‘Caution: To be taken under
medical supervision’ both in English and Hindi language.

SCHEDULE ‘D (II)’
Information required to be submitted by the manufacturer or his authorized agent
with the Application Form for the registration of a bulk drug/formulation/special
product for its import into India.
The format shall be properly filled in and the detailed information, secret in
nature,
may be furnished on a Computer Floppy.
SCHEDULE ‘FF’. STANDARDS FOR OPHTHALMIC
PREPARATIONS
be sterile when dispensed or when sold in the unopened container of the
manufacturer, except in case of those ophthalmic solutions and suspensions
which are not specifically required to comply with the test for ‘Sterility’ in the
Pharmacopoeia

SCHEDULE. ‘I’
particulars as to proportion of poison in certain cases
SCHEDULE ‘J’
Diseases and ailments (by whatever name described) which a drug may not
purport to prevent or cure or make claims to prevent or cure.
SCHEDULE ‘L’

SCHEDULE ‘N’
list of minimum equipment for the efficient running of a pharmacy
SCHEDULE ‘O’
standard for disinfectant fluids
the disinfectants shall be classified as follows:
(A)black fluids ; coal tar acid or similar acids
(b)white fluids; without hydrocarbons, and/or other phenolic compounds, and
their derivatives.
SCHEDULE ‘P’; LIFE PERIOD OF DRUGS
period in months (unless otherwise specified) between date of manufacture
and date of expiry which the labelled potency period of the drug shall not
exceed under the conditions of storage specified

SCHEDULE ‘S’ ; STANDARDS FOR COSMETICS IN
FINISHED FORM
Shall conform to the Indian Standards specifications laid down from time to time
by the 3[Bureau of Indian Standards (BIS)].
SCHEDULE ‘W’;
INSERTED AS PER G.O.I. NOTIFICIATION NO. GSR 27(E) DT 17.1.1981 AND
DELETED
AS PER G.O.I. NOTIFICATION NO. GSR 94(E) DT 8.2.2000.

(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
• Schedule – D(II)-Information –product
Registration for import

(sch A to Y)
• 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

(sch A to Y)
• SCHEDULE FF – Standards Ophthalmic
preparations
• 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

(sch A to Y)
• 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
• SCHEDULE P – Life Period of drugs
• SCHEDULE P 1 –Pack size of drugs
•  Dr. Maitreyi N. Zaveri, KBIPER 101

(sch A to Y)
• 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
• SCHEDULE U – RECORDS-DRUGS
• SCHEDULE U1- Records Cosmetics

(sch A to Y)
• 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.

THE DRUGS TECHNICAL ADVISORY BOARD, THE
CENTRAL DRUGS LABORATORY AND THE DRUGS
CONSULTATIVE COMMITTEE
• 5. The Drugs Technical Advisory Board.
• 6. The Central Drugs Laboratory.
• 7. The Drugs Consultative Committee.
• 7A. Sections 5 and 7 not to apply to
Ayurvedic, Siddha or Unani drugs.

CHAPTER III IMPORT OF DRUGS AND COSMETICS
• 8. Standards of quality.
• 9. Misbranded drugs. 9A. Adulterated drugs. 9B. Spurious
drugs. 9C. Misbranded cosmetics. 9D. Spurious cosmetics.
• 10. Prohibition of import of certain drugs or cosmetics. 10A.
Power of Central Government to prohibit import of drugs
and cosmetics in public interest.
• 11. Application of law relating to sea customs and powers
of Customs officers.
• 2. Power of Central Government to make rules. 13.
Offences.
• 14. Confiscation.
• 15. Jurisdiction.

CHAPTER IV--MANUFACTURE, SALE AND
DISTRIBUTION OF DRUGS AND COSMETICS
• 16. Standards of quality.
• 17. Misbranded drugs. 17A. Adulterated drugs. 17B. Spurious
drugs. 17C. Misbranded cosmetics. 17D. Spurious cosmetics.
• 8. Prohibition of manufacture and sale of certain drugs and
cosmetics. 18A. Disclosure of the name of the manufacturer, etc.
18B. Maintenance of records and furnishing of information.
• 19. Pleas.
• 20. Government Analysts.
• 21. Inspectors.
• 22. Powers of Inspectors.
• 23. Procedure of Inspectors.
• 24. Persons bound to disclose place where drugs or cosmetics are
manufactured or kept.
• 25. Reports of Government Analysts.

• 26. Purchaser of drug or cosmetic enabled to obtain test or analysis.
26A. Power of Central Government to prohibit manufacture, etc., of
drug and cosmetic in public interest.
• 27. Penalty for manufacture, sale, etc., of drugs in contravention of
this Chapter. 27A. Penalty for manufacture, sale, etc., of cosmetics
in contravention of this Chapter.
• 28. Penalty for non-disclosure of the name of the manufacturer, etc.
28A. Penalty for not keeping documents, etc., and for non-
disclosure of information. 28B. Penalty for manufacture, etc. of
drugs or cosmetics in contravention of section 26A.
• 29. Penalty for use of Government Analyst’s report for advertising.
30. Penalty for subsequent offences.
• 31. Confiscation. 31A. Application of provisions to Government
departments.
• 32. Cognizance of offences. 32A. Power of Court to implead the
manufacturer, etc.
• 33. Power of Central Government to make rules. 33A. Chapter not
to apply to Ayurvedic, Siddha or Unani drugs.

The drugs and cosmetics act and rules cosmetics-mnz

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to The drugs and cosmetics act and rules cosmetics-mnz

Similar to The drugs and cosmetics act and rules cosmetics-mnz (20)

Recently uploaded

Recently uploaded (20)

The drugs and cosmetics act and rules cosmetics-mnz