D&c act

G.ANANTH REDDY
M-PHARM(PHARMACEUTICS)
I YR II SEM

 The Drugs and Cosmetics act was passed in 1940,with main
object to regulate the import, manufacture, distribution and sale of
Drugs and Cosmetics.
 The Act regulates the import of drugs into India so that no
substandard or spurious drug will find its way in the country.
 The Act regulates the manufacture by making provisions, and
rules, which provide control over the sale and distribution of drugs
by only registered pharmacists and competent persons.
 Act also provides for the control over the manufacturer, sale and
distribution of Ayurvedic, Siddha, Unani and Homeopathic drugs.

 The Act consists of five chapters each
chapter related to particular subject
 Chapter I --- introductory/definitions
 Chapter II --- drugs technical advisory board,
central drugs laboratory,
drugs consultative committee
 Chapter III --- import of drugs and cosmetics
 Chapter IV --- manufacture, sale and distribution of
Drugs and Cosmetics
 Chapter V --- miscellaneous

FIRST SCHEDULE:
List of Ayurvedic, Siddha and Unani books.
SECOND SCHEDULE:
Standards to be compiled with by imported drugs and
by drugs manufactured for sale, sold, stocked or exhibited for
sale or distributed.

1) SHORT TITLE, EXTENT AND COMMENCEMENT:
 This act may be called the Drugs (and cosmetics) Act, 1940.
 It extends to the whole of India.
2) APPLICATION OF OTHER LAWS NOT BARRED:
 The provisions of this Act shall be in addition to, and not in
derogation of, the Dangerous Drugs Act, 1930 (2 of 1930), and
any other law for the time being in force.

3) DEFINITIONS:
 In this Act, unless there is anything repugnant in the subject or
context,
 “ Ayurvedic,Siddha or Unani drug” includes all medicines
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) exclusively in
accordance with the formulae described in, the authoritative
beeks of (Ayurvedis, Siddha and Unani Tibb systems of
medicine), specified in the First Schedule.
4) PRESUMPTION AS TO POISONOUS
SUBSTANCES:
Any substance specified as poisonous by rule made under
chapter II or chapter IV shall be deemed to be a poisonous
substance for the purposes of chapter III or chapter IV, as the
case may be.

 THE DRUGS TECHNICAL ADVISORY BOARD, THE
CENTRAL DRUGS LABORATORY AND THE DRUGS
CONSULTATIVE COMMITTEE:
 THE DRUGS TECHNICAL ADVISORY BOARD:
 The Central Government shall, as soon as may be, constitute a
Board to advise the Central Government and the state
Governments on technical matters arising out oh the
administration of this Act and to carry out the other functions
assigned to it by this Act.
 The Board shall consist of the following members, namely:
 i) the Director-General of Health Services, ex officio, who shall be
Chairman;
 ii) the Drugs Controller, India, ex officio;
 iii) the Director of the Central Drugs Laboratory, Calcutta, ex
officio;

 The director of Central Research Institute
 The Director of Indian Veterinary Research Institute
 The President of Medical Council of India
 The President of Pharmacy Council of India
 The director of Central Drug Research Institute
 Two persons can be nominated by Central Government
from among two persons who are in charge of drugs
control in the states
 One person can be elected by Executive Committee of the
Pharmacy council of India.
 One person can be elected by Executive Committee of the
Medical council of India.
 One person to be nominated by central government from
pharmaceutical industry
 One pharmacologist to be elected by Governing Body of
Indian council of Medical Research.

 xiv) one person to be elected by the Central Council of the Indian
Medical Association;
 xv) one person to be elected by the Council of the Indian
Pharmaceutical Association;
 xvi) two persons holding the appointment of Government analyst
under this Act, to be nominated by the Central Government;
 The nominated and elected members of the Board shall hold office
for 3 yrs but shall be eligible for re-nomination and re-election;
 THE CENTRAL DRUGS LABORATORY:
 1) Director to be appointed by the Central Government, to carry
out the functions entrusted to it by this Act.
 2) the Central Government may, after consultation with the Board
make rules prescribing-
 a) the functions of Central Drugs laboratory,
 b) the procedure for the submission to the said laboratory for
analysis or test, the forms of the laboratory’s reports their on and
the fees payable in respect of such reports;

 c) such other matters as may be necessary or expedient to
enable the said laboratory to carry out its functions;
 THE DRUGS CONSULTATIVE COMMITTEE:
 1) to advise the Central Government, the state Governments and
the Drugs technical advisory Board on any matter tending to
secure uniformity throughout in administration of this Act.
 2) the drugs consultative committee shall 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.
 3) the Drugs consultative committee shall meet which required to
do so by the Central Government and shall have power to regulate
its own procedure.

CHAPTER III
IMPORT OF DRUGS AND COSMETICS
 STANDARDS OF QUALITY:
 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 complies with such
standard as may be prescribed.
 MISBRANDED DRUGS:
 a) if it is so colored, coated, powdered or polished that damage is
concealed or if it is made to appear of better or greater therapeutic
value then it really is; or
 b) if it is not labelled in he prescribed manner; or
 c) it 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 drug shall be deemed to be adulterated,
 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 contaminated with filth or where by it may have been
rendered injurious to health;
 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;
 d) if it bears or contents, for the purpose of coloring only, a color
other than one which is prescribed;
 e) if it contains any harmful or toxic substance which may render it
injurious to health;
 f) if any substance has been mixed theirwith so has to reduce its
quality or strength.

 SPURIOUS DRUGS:
 a) if it is imported under a name which belongs to another drug;
 b) 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
 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:
 For the purposes of this chapter. A cosmetic shall be deemed to
be misbranded
 a) if it contains a color 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:
 a) if it is imported under a name which belongs to another
cosmetic; or
 b) if the label or container bears the name of an individual or a
company purporting to be the manufacturer of whom it is not truly
a product.
 c) if it purports to be the product of a manufacturer of whom it is
not truly a product.

 PROHIBITION OF IMPORT OF
CERTAIN DRUGS OR COSMETICS:
 a) any drug (or cosmetic) which is not of
standard quality;
 b) any misbranded drug or misbranded
cosmetic;
 c) any drug or cosmetic for the import of which
a licence is prescribed, otherwise than under,
and in accordance with, such licence

CHAPTER IV
MANUFACTURE, SALE AND DISTRIBUTTION OF
COSMETICS
 STANDARDS OF QUALITY:
 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 complies with such
standard as may be prescribed.
 MISBRANDED DRUGS:
 a) if it is so colored, coated, powdered or polished that damage is
concealed or if it is made to appear of better or greater therapeutic
value then it really is; or
 b) if it is not labelled in he prescribed manner; or
 c) it 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.

PROHIBITION OF MANUFACTURE AND
SALE OF CERTAIN DRUGS AND
COSMETICS:
 a) manufacture for sale or sell, or stock or exhibit for sale, or
distribute.
 b) sell, or stock or exhibit for sale, or distribute any drug 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 sell, or stock or exhibit for sale, or
distribute any drug, except under, and in accordance with the
conditions of, a licence issued for such purpose under this
chapter.

 APPLICATION OF CHAPTER IV-A:
 This chapter shall apply only to (Ayurvedic, Siddha and Unani
drugs)
 The Board shall consist of the following members, namely:
 i) The Director-General of Health Services, ex officio;
 ii) the Drugs Controller, India, ex officio;
 iii) the principal officer dealing with Indian systems of medicine in
the Ministry of Health, ex officio;
 iv) the Director of the Central Drugs Laboratory, Calcutta, ex
officio;
 v) one person holding the appointment of Government Analyst
under section 34-F, to be nominated by the Central Government;
 vi) one Pharmacognocist to be nominated by the Central
Government;

 vii) one Phyto-chemist to be nominated by the Central
Government;
 viii) four persons to be nominated by the Central Government, two
from amongst the members of the Ayurvedic pharmacopoeia
committee, one from amongst the members of the Unani
Pharmacopoeia committee and one from amongst the members of
the Siddha Pharmacopoeia committee;
 ix) one teacher in Darvyaguna, and Bhaishajya kalpana, to be
nominated by the Central Government;
 x) one teacher in ILM-UL-ADVIA and TAKLIS-WADAWASAZI, to
be nominated by the Central Government;
 xi) one teacher in Gunapadam to be nominated by the Central
Government;
 xii) three persons, one each to represent the Ayurvedic, Siddha
and Unani drug industry, to be nominated by the Central
Government;

 xiii) three persons, one each from among the practitioners of
Ayurvedic, Siddha and Unani Tibb systems of medicine to be
nominated by the Central Government.
 The Central Government shall appoint a member of the Board as
its Chairmen.
 The nominated members of the Board shall hold office for three
yrs but shall be eligible for renomination.
 The Board may, subject to the previous approval of the Central
Government, make bye-laws fixing a quorum and regulating its
own procedure and conduct of all business to be transacted by it.
 The functions of the Board may be exercised notwithstanding any
vacancy therein.
 The Central Government shall appoint a person to be secretary of
the Board and shall provide the Board with such clerical and other
staff as a Central Government considers necessary.

 THE AYURVEDIC, SIDDHA AND UNANI DRUGS
CONSULTATIVE COMMITTEE:
 1) The Ayurvedic, Siddha and Unani drugs consultative committee
shall consist of two persons to be nominated by the Central
Governments as representatives of that Government and not more
than one representative of each state to be nominated by the
State Government concerned.
 2) The Ayurvedic, Siddha and Unani drugs consultative committee
shall meet when required to do so by the Central Government and
shall regulate its own procedure.
 GOVERNMENT ANALYST:
 1) Neither the Central Government nor a state Government shall
appoint as a Government analyst any official not serving under it
without the previous consent of the Government under which he is
serving.
 2) No person who has any financial interest in the manufacture or
sale of any drug shall be appointed to be a Government Analyst
under the section.

 INSPECTORS:
 1) The power which may be exercised by an inspector and the
duties which may be performed by him and the conditions,
limitations or restriction subject to which such powers and duties
may be exercised or performed shall be such as may be
prescribed.
 2) No person who has any financial interest in the manufacture or
sale of any drug shall be appointed to be an inspector under the
section.
 3) Every inspector shall be deemed to be a public servant within
the meaning of section 21 of the Indian penal code(45 of 1860)
and shall be officially subordinate to such authority as the
Government appointing him may specify in this behalf.

 CONFISCATION:
 Where any person has been convicted under this chapter, the stock
of the Ayurvedic, Siddha or Unani drug in respect of which the
contravention has been made, shall be liable to confiscation.
 APPLICATION OF PROVISIONS TO GOVERNMENT
DEPARTMENTS:
 The provisions of this chapter expect those contained in section 33-
K shall apply in relation to the manufacture for sale, sale or
distribution of any Ayurvedic, Siddha or Unani drug by any
department of Government as they apply in relation to the
manufacture for sale, sale or distribution of such drug by any other
person.

 COGNIZANCEE OF OFFENCES:
 1)No prosecution under this chapter shall be instituted except by
an inspector (with the previous sanction of the authorities specified
under sub section (4) of section 33-G).
 2) No court inferior to that shall try an offence punishable under
this chapter.

CHAPTER V
MISCELLANEOUS
 POWER TO GIVE DIRECTIONS:
 The Central Government may give such directions
to any State Government as may appear to the
Central Government to be necessary for carrying
into execution in the State any of the provisions of
this Act or of any rule or order made thereunder.

 OFFECNE 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 the
business of the company.
 2) Notwithstanding anything contained in subsection
(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, secretory or
other officer shall also be deemed to be guilty of that
offence and shall be liable to proceeded against and
punished accordingly.

 EXPLANATION:
 For the purpose of this section:
 a) “Company” means a body corporate, and
includes a firm or other association of
individuals; and
 b) “Director” in a relation to a firm means a
partner in the firm.

D&c act

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