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GOVERNMENT OF
MINISTRY OF HEALTH AND
FAMILY WELFARE
(Department
of Health)
THE DRUGS AND
COSMETICS ACT AND RULES
THE
DRUGS AND COSMETICS ACT, 1940
CHAPTER
I
INTRODUCTORY
SECTIONS
1.
Short title, extent and commencement.
2.
Application of other laws not barred.
3.
Definitions
3A.
Construction of references to any law not in force or any functionary not in
existence in the State of
4.
Presumption as to poisonous substances.
CHAPTER
II
THE
DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORTORY AND THE
DRUGS CONSULTATIVE COMMITTEE
5.
The Drugs Technical Advisory Board.
6.
The Central Drugs Laboratory.
7.
The Drugs Consultative Committee.
7A.
Section 5 and 7 not to apply 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.
12
Power of Central Government to make rules.
13
Offences.
14
Confiscation
15.
Jurisdiction
CHAPTER
IV
MANUFACTURE,
16.
Standards of quality.
17.
Misbranded drugs.
17A.
Adulterated drugs.
17B.
Spurious drugs.
17C.
Misbranded cosmetics.
17D.
Spurious cosmetics.
18.
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.
CHAPTER
IVA
PROVISIONS
RELATING TO AYURVEDIC SIDDHA AND UNANI DRUGS
SECTIONS
33B.
Application of Chapter IVA.
33C.
Ayurvedic, Siddha and Unani Drugs Technical Advisory Board.
33D.
The Ayurvedic, Siddha and Unani Drugs Consultative Committee.
33E.
Misbranded drugs.
33EE.
Adulterated drugs.
33EEA.
Spurious drugs.
33EEB.
Regulation of manufacture for sale of Ayurvedic, Siddha and Unani drugs.
33EEC.
Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani
drugs.
33EED.
Power of Central Government to prohibit manufacture etc., of Ayurvedic,
Siddha or Unani drugs in public interest.
33F.
Government Analysts.
33G.
Inspectors .
33H.
Application of provisions of sections 22, 23, 24 and 25.
33I.
Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drugs in
contravention of this Chapter.
33J.
Penalty for subsequent offences.
33K.
Confiscation .
33L.
Application of provisions to Government departments.
33M.
Cognizance of offences.
33N.
Power of Central Government to make rules.
33O.
Power to amend First Schedule.
CHAPTER
V
MISCELLANEOUS
33P.
Power to give directions.
34.
Offences by companies.
34A.
Offences by Government departments.
34AA.
Penalty vexatious search or seizure.
35.
Publication of sentences passed under this Act.
36.
Magistrate’s power to impose enhanced penalties.
36A.
Certain offences to be tried summarily.
37.
Protection of action taken in good faith.
38.
Rules to be laid before Parliament.
THE
FIRST SCHEDULE
THE
SECOND SCHEDULE
THE
DRUGS AND COSMETICS ACT, 1940 23 OF 1940 [10th April, 1940]
[PASSED
BY THE INDIAN LEGISLATURE]
(Received
the assent of the Governor General on the 10th April, 1940)
As
Amended by Act No. II of 1955
[PASSED
BY THE INDIAN PARLIAMENT]
(Received
the assent of the President on the 15th April, 1955)
As
Amended by Act No. 35 of 1960
[PASSED
BY THE INDIAN PARLIAMENT]
(Received
the assent of the President on the 15th September, 1960)
As
Amended by Act No. 21 of 1962
[PASSED
BY THE INDIAN PARLIAMENT]
(Received
the assent of the President on the 27th June, 1962)
As
Amended by Act No. 13 of 1964
[PASSED
BY THE INDIAN PARLIAMENT]
(Received
the assent of the President on the 12th May, 1964)
As
Amended by Act No.19 of 1972
[PASSED
BY THE INDIAN PARLIAMENT]
(Received the assent of the President
on the 31st May, 1972)
As
Amended by Act No.68 of 1982
[PASSED
BY THE INDIAN PARLIAMENT]
(Received
the assent of the President on the 13th November, 1982)
As
Amended by Act No. 71 of 1986
[PASSED
BY THE INDIAN PARLIAMENT]
(Received
the assent of the President on the 24th December, 1986)
As
Amended by Act 22 of 1995.
[PASSED
BY THE INDIAN PARLIAMENT]
(Received
the assent of the President
CHAPTER
I
INTRODUCTORY
1.
Short title, extent and commencement. –(1) This Act may be
called the Drugs [and Cosmetics] Act, 1940.
(2)
It
extends to the whole of
(3)
It
shall come into force at once; but Chapter III shall take the effect only
from such date as the Central Government may, by notification in the Official
Gazette, appoint in this behalf, and Chapter IV shall take effect in a
particular State only from such date as the State Government may, by like notification,
appoint in this behalf:
[Provided
that in relation to the State of Jammu and Kashmir, Chapter III shall take
effect only from such date after the commencement of the Drugs and Cosmetics
(Amendment) Act, 1972 19of 1972, as the Central Government may, by
notification in the Official Gazette, appoint in this behalf.]
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 orcontext,--
[(a)
“Ayurvedic, Siddha6 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 books of Ayurvedic, Siddha and Unani (Tibb) systems of
medicine], specified in the First Schedule;]
[(aa)
“the Board” means—
(i)
in
relation to Ayurvedic, Siddha or Unani drug, the Ayurvedic, Siddha or Unani
Drugs Technical Advisory Board] constituted under section 33C; and
(ii)
in
relation to any other drug or cosmetic, the Drugs Technical Advisory Board
constituted under section 5;]
[4
(aaa) ] “cosmetic” means any article intended to be rubbed, poured,
sprinkled or sprayed on, or introduced into, or otherwise applicated 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]
[(b)
“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
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 ;]
[(c)
“Government Analyst” means—
(i)
in
relation to Ayurvedic, Siddha or Unani drug, a Government Analyst appointed
by 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;]
(d)
omitted by Act 19 of 1972, s 3.
[(e)
“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;]
(f)
“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;]
[(g)]
“to import”, with its grammatical variations and cognate expressions means to
bring into [
[(h)]
“patent or proprietary medicine” means, --
(i)
in
relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all
formulations containing only such ingredients mentioned in the formulae
described in the authoritative books of Ayurveda, Siddha or Unani Tibb
systems of medicine specified in the First Schedule, but does not include a medicine
which is administered by parenteral route and also a formulation included in
the authoritative books as specified in clause (a); (ii) in
relation to any other systems of 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 Indian Pharmacopoeia for the time being or any other Pharmacopoeia
authorized in this behalf by Central Government after consultation with the
Drugs Technical Advisory Board constituted under section 5;]]
(i)] “prescribed”
means prescribed by rules made under this Act.]
*
* * * * *
3A.
Construction of references to any law not in force or any functionary
not in existence in the State of
4.
Presumption as to poisonous substances. —Any substance specified as
poisonous by rule made under Chapter III or Chapter IV [or Chapter IVA] shall
be deemed to be a poisonous substance for the purposes of Chapter III or Chapter
IV [or Chapter IVA], as the case may be.
CHAPTER
II
THE
DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABOURATORY AND THE DRUGS
CONSULTATIVE COMMITTEE
5.
The Drugs Technical Advisory Board. — (1) The Central Government
shall, as soon as may be, constitute a Board (to be called 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.
(2)
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,
(iii)
the
Director of the Central Drugs Laboratory,
(iv)
the
Director of the Central Research Institute, Kasauli, ex officio;
(v)
the
Director of Indian Veterinary Research Institute, Izatnagar, ex officio;
(vi)
the
President of Medical Council of India, ex officio;
(vii)
the
President of the Pharmacy Council of India, ex officio;
(viii)
the
Director of Central Drug Research Institute,
(ix)
two
persons to be nominated by the Central Government from among persons who are
in charge of drugs control in the States;
(x)
one
person, to be elected by the Executive Committee of the Pharmacy Council of
India, from among teachers in pharmacy or pharmaceutical chemistry or
pharmacognosy on the staff of
(xi)
one
person, to be elected by the Executive Committee of the Medical Council of
India, from among teachers in medicine or therapeutics on the staff of an
(xii)
one
person to be nominated by the Central Government from the pharmaceutical industry;
(xiii)
one
pharmacologist to be elected by the Governing Body of the 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.]
(3)
The nominated and elected members of the Board shall hold office for
three years, but shall be eligible for re-nomination and re-election:
[Provided
that the person nominated or elected, as the case may be, under clause (ix)
or clause (x) or clause (xi) or clause (xvi) of
sub-section (2) shall hold office for, so long as he holds the
appointment of the office by virtue of which he was nominated or elected to
the Board.]
(4)
The Board may, subject to the previous approval of the Central
Government, make bye-laws fixing a quorum and regulating its own procedure
and the conduct of all business to be transacted by it.
(5)
The Board may constitute sub-committees and may appoint to such
sub-committees for such periods, not exceeding three years, as it may decide,
or temporarily for the consideration of particular matters, persons who are
not members of the board.
(6)
The functions of the Board may be exercised notwithstanding any vacancy
therein.
(7)
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 the
Central Government considers necessary.
6.
The Central Drugs Laboratory. -- (1) The Central Government shall,
as soon as may be, established a Central Drugs Laboratory under the control
of a Director to be appointed by the Central Government, to carry out the
functions entrusted to it by this Act or any rules made under this Chapter:
Provided
that, if the Central Government so prescribes, the functions of the Central
Drugs Laboratory in respect of any drug or class of drugs 1[or cosmetic or
class of cosmetics] shall be carried out at the Central Research Institute,
Kasauli, or at any other prescribed Laboratory and the functions of the
Director of the Central Drugs Laboratory in respect of such drug or class of
drugs [or such cosmetic or class of cosmetics] shall be exercised by the
Director of that Institute or of that other Laboratory, as the case may be.
(2)
the
Central Government may, after consultation with the Board, make rules
prescribing—
(a)
the
functions of the Central Drugs Laboratory;
*
* * * * *
(d)
the
procedure for the submission to the said Laboratory [under Chapter IV or
Chapter IVA]of samples of drugs [or cosmetics] for analysis or test, the
forms of Laboratory’s reports thereon and the fees payable in respect of such
reports;
(e)
such
other matters as may be necessary or expedient to enable the said Laboratory
to carry out its functions;
(f)
the
matters necessary to be prescribed for the purpose of the proviso to
subsection (1).
7.
The Drugs Consultative Committee. —(1) The Central Government may
constitute an advisory committee to be called “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.
(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 when required to do so by the Central
Government and shall have power to regulate its own procedure.
[7A.
Sections 5 and 7 not apply to Ayurvedic, Siddha or
Unani drugs. — Nothing contained in sections 5 and 7 shall apply to
Ayurvedic, Siddha or Unani drugs.]
CHAPTER
III
[IMPORT
OF DRUGS AND COSMETICS]
8.
Standards of quality. —(1) For the purposes of this Chapter, the
expression “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.]
(2)
The
Central Government, after consultation with the Board and after giving by
notification in the Official Gazette not less than three months’ notice of
its intention so to do, may by a like notification add to or otherwise amend
[the Second Schedule], for the purpose of this Chapter, and thereupon [the
Second Schedule] shall be deemed to be amended accordingly.
9.
Misbranded drugs. ---For the purposes of this Chapter 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; ]
9A.
Adulterated drugs. -- For the purposes of this Chapter, 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 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.
9B.
Spurious drugs. -- For the purposes of this Chapter, a drug shall
be deemed to be spurious—
(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
(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.
9C.Misbranded
cosmetics. ---For the purposes of this chapter, 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 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.
9D.
Spurious cosmetics. --For the purposes of this Chapter, a drug shall
be deemed to be spurious, --
(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
(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].
10.
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;]
[(bb)
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;
(d)
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);]
(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;
(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:
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.
10A.
Power of Central Government to prohibit import of drugs and cosmetics in
public interest. — Without prejudice to any other provision contained in
this Chapter, if the Central Government is satisfied that the use of
any drug or cosmetic is likely to involve any risk to human beings or
animals or that any drug does not have the therapeutic value claimed for it
or contains ingredients and in such quantity for which there is no
therapeutic justification and that in the public interest it is
necessary or expedient so to do then, that Government may, by notification
in the Official Gazette, prohibit the import of such drug or cosmetic.]
11.
Application of law relating to sea customs and powers of Customs
Officers. – (1) Thelaw for the time being in force relating to sea
customs and to goods, the import of which is prohibited by section 18 of the
Sea Customs Act, 18781 (8 of 1878) shall, subject to the provisions of
section 13 of this Act, apply in respect of drugs [and cosmetics] the import
of which is prohibited under this Chapter, and officers of Customs and
officers empowered under that Act to perform the duties imposed thereby on a
Customs Collector and other officers of Customs, shall have the same powers
in respect of such drugs [and cosmetics] as they have for the time being in
respect of such goods as aforesaid.
(2)
Without
prejudice to the provisions of sub-sections (1), the Customs Collector
or any other officer of the Government authorized by the Central Government
in this behalf, may detain any imported package which he suspects to contain
any drug [or cosmetic] the import of which is prohibited under this Chapter
and shall forthwith report such detention to the Drugs Controller, India,
and, if necessary, forward the package or sample of any suspected drug [or
cosmetic] found therein to the Central Drugs Laboratory.]
12.
Power of Central Government to make rules. —(1) The Central
Government may, after consultation with (or on the recommendation of the
Board) and after previous publication by notification in the Official
Gazette, make rules for the purpose of giving effect to the provisions of
this Chapter:
[Provided
that consultation with the Board may be dispensed with if the Central
Government is of opinion that circumstances have arisen which render it
necessary to make rules without such consultation, but in such a case the
Board shall be consulted within six months of the making of the rules and the
Central Government shall take into consideration any suggestions which the
Board may make in relation to the amendment of the said rules.]
(2)
Without
prejudice to the generality of the forgoing power, such rules may— (a) specify
the drugs or classes of drugs [or cosmetics or classes of cosmetics] for the
import of which a licence is required, [and prescribe the form and conditions
of such licences, the authority empowered to issue the same, the fees payable
therefor and provide for the cancellation, or suspension of such licence in
any case where any provision of this Chapter or the rules made thereunder is
contravened or any of the conditions subject to which the licence is issued
is not complied with];
(b)
prescribe
the methods of test or analysis to be employed in determining whether a drug
[or cosmetic] is of standard quality;
(c)
prescribe,
in respect of biological and organometallic compounds, the units or methods
of standardization;
[(cc)
prescribe under clause (d) of (section 9A) the colour or colours
which a drug may bear or contain for purposes or colouring;]
(d)
specify
the diseases or ailments which an imported drug may not purport or claim [to
prevent, cure or mitigate] and such other effects which such drug may not
purport or claim to have;
(e)
prescribe
the conditions subject to which small quantities of drugs, the import of
which is otherwise prohibited under this Chapter, may be imported for the
purpose of examination, test or analysis or for personal use;
(f)
prescribe
the places at which drugs [or cosmetics] may be imported, and prohibit their
import at any other place;
(g)
require
the date of manufacture and the date of expiry of potency to be clearly and
truly stated on the label or container of any specified imported drug or
class of such drugs, and prohibit the import of the said drug or class of
drugs after the expiry of a specified period from the date of manufacture;
(h)
regulate
the submission by importers, and the securing, of samples of drugs [or
cosmetics] for examination, test or analysis by the Central Drugs Laboratory,
and prescribe the fees, if any, payable for such examination, test or
analysis;
(i)
prescribe
the evidence to be supplied, whether by accompanying documents or otherwise, of
the quality of drugs [ or cosmetics] sought to be imported, the procedure of
officers of Customs in dealing with such evidence, and the manner of storage
at places of import of drugs [ or cosmetics] detained pending admission;
(j)
provide
for the exemption, conditionally or otherwise, from all or any of the
provisions of this Chapter and the rules made thereunder of drugs [or
cosmetics] imported for the purpose only of transport through, an export
from, [
(k)
prescribe
the conditions to be observed in the packing in bottles, packages or other
containers, of imported drugs [including the use of packing material which
comes into direct contact with the drugs] [or cosmetics];
(l)
regulate
the mode of labeling drugs [or cosmetics] imported for sale in packages, and
prescribe the matters which shall or shall not be included in such labels;
(m)
prescribe
the maximum proportion of any poisonous substance which may be added to or
contained in any imported drug, prohibit the import if any drug in which that
proportion is exceeded, and specify substances which shall be deemed to be
poisonous for the purposes of this Chapter and the rules made thereunder;
(n)
require
that accepted scientific name of any specified drug shall be displayed in the
prescribed manner on the label or wrapper of any imported, patent or
proprietary medicine containing such drug;
(o)
provide
for the exemption, conditionally or otherwise, from all or any of the
provisions of this Chapter or the rules made thereunder of any specified drug
or class of drugs [or cosmetic or class of cosmetics].
[13.
Offences. —(1) Whoever himself or by any other person on his
behalf imports,- (a) any drug deemed to be adulterated under section
9A or deemed to be a spurious drug under section 9B or any spurious cosmetic
referred to in section 9D or any cosmetic of the nature referred to in clause
(ee) of section 10 shall be punishable with imprisonment for a term
which may extend to three years and a fine which extend to five thousand
rupees;]
[(b)
any drug or cosmetic other than a drug or cosmetic referred to in clause (a),
the import of which is prohibited under section 10, or any rule made under
this Chapter, shall be punishable with imprisonment for a term which may
extend to six months, or with fine which extend to five thousand rupees or
both;
(c)
any
drug or cosmetic in contravention of the provision of any notification issued
under section 10A, shall be punishable with imprisonment for a term which may
extend to three years, or with fine which extend to five thousand rupees, or
both;
(2)
Whoever
having been convicted of an offence—
(a)
under
clause (a) or clause (c) of sub-section (1), is again
convicted of an offence under that clause, shall be punishable with
imprisonment for a term which may extend to ten thousand rupees, or with
both;
(b)
under
clause (b) of sub-section (1),is again convicted of an offence
under that clause, shall be punishable with imprisonment for a term which may
extend to one year, or with fine which may extend to one thousand rupees, or
with both
(3)
The
punishment provided by this section shall be in addition to any penalty to
which the offender may be liable under the provision of section 11.]
14.Confiscation.
—Where any offence punishable under section 13 has been committed, the
consignment of the drugs [or cosmetics] in respect of which the offence has
been committed shall be liable to confiscation.
15.
Jurisdiction. —No Court inferior to that of a [Metropolitan]
Magistrate or of a [Judicial] Magistrate of the first class shall try an
offence punishable under section 13.
CHAPTER
IV
MANUFACTURE,
16.
Standards of quality. —3[(1) For the purposes of this Chapter,
the expression “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 complies with such standard as may be
prescribed.]
(2)
The
[Central Government], after consultation with the Board and after giving by notification
in the Official Gazette not less than three months’ notice of its intention
so to do, may by a like notification add to or otherwise amend [the Second
Schedule] for the purpose of this Chapter, and thereupon [the Second
Schedule] shall be deemed to be amended accordingly.
17.
Misbranded drugs. —For the purposes of this Chapter 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 that 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.
17A.
Adulterated drugs. -- For the purpose of this Chapter, a cosmetic
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
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 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.
17B.Spurious
drugs. --For the purposes of this Chapter 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 bear 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.
17C.
Misbranded cosmetics. —For the purposes of this Chapter, 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)
the
label or any container or anything accompanying the cosmetic bears any statement
which is false or misleading in any particular.
17D.
Spurious cosmetics.—For the purposes of this Chapter, a cosmetic shall be
deemed to be spurious,--
(a)
if it is manufactured under a name which belongs to another cosmetic; or]
(b)
if it is an intimation 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.]
18.
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 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 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 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
:
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:
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 [manufacture for sale, or for
distribution, sale, stocking or exhibiting or offering for sale or
distribution] of any drug or class of drugs not being of standard quality.
18A.
Disclosure of the name of the manufacturer, etc.—Every person, not
being the manufacturer of a drug or cosmetic or his agent for the
distribution thereof, shall, if so required, disclose to the Inspector the
name, address and other particulars of the person from whom he acquired the
drug or cosmetic.]
18B.
Maintenance of records and furnishing of information. —Every
person holding a licence under clause (c) of section 18 shall keep and
maintain such records, registers and other documents as may be prescribed and
shall furnish to any officer or authority exercising any power or discharging
any function under this Act such information as is required by such officer
or authority for carrying out the purposes of this Act.]
19.Pleas.
—(1) Save as hereinafter provided in this section, it shall be no defence
in a prosecution under this Chapter to prove merely that the accused was
ignorant of the nature, substance or quality of drug [or cosmetic] in respect
of which the offence has been committed or of the circumstances of its
manufacture or import, or that a purchaser, having bought only for the
purpose of test or analysis, has not been prejudiced by the sale.
(2)
[For
the purposes of section 18 a drug shall not be deemed to be misbranded or adulterated
[or spurious] or to be below standard quality nor shall a cosmetic be deemed
to be misbranded or to be below standard quality] only by reason of the fact
that—
(a)
there
has been added thereto some innocuous substance or ingredient because the same
is required for manufacture or preparation of the drug [or cosmetic] as an article of commerce in a
state fit for carriage or consumption, and not to increase the bulk, weight or
measure of the drug [or cosmetic]or to conceal its inferior quality or other
defects; or
(b) in the process of manufacture,
preparation or conveyance some extraneous substance has unavoidably become
intermixed with it: Provided that this clause shall not apply in relation to
any sale or distribution of the drug [or cosmetic] occurring after the vendor
or distributor became aware of such intermixture.
(3)
A
person, not being the manufacturer of a drug or cosmetic or his agent for the
distribution thereof, shall not be liable for a contravention of section 18
if he proves—
(a)
that
he acquired the drug or cosmetic from a duly licensed manufacturer, distributor
or dealer thereof;
(b)
that
he did not know and could not ,with reasonable diligence, have ascertained that
the drug or cosmetic in any way contravened the provisions of that section
;and
(c)
that
the drug or cosmetic, while in his possession, was properly stored and remained
in the same state as when he acquired it .]
20.Government
Analysts. — (1) The State Government may, by notification in the Official
Gazette, appoint such persons as it thinks fit, having the prescribed
qualifications, to be Government Analysts for such areas in the state and in
respect of such drugs or [classes of drug or such cosmetics or classes of
cosmetics] as may specified in the notification.
(2)
The
Central Government may also, by notification in the Official Gazette, appoint
such persons as it thinks fit, having the prescribed qualifications, to be
Government Analysts in respect of such drugs or [classes of drugs or such
cosmetics or classes of cosmetics] as may be specified in the notification.
(3) Notwithstanding anything contained in
sub-section (1) or sub-section (2), 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.
(4)
No
person who has any financial interest in the import, manufacture or sale of
drugs or cosmetics shall be appointed to be a Government Analyst under
sub-section (1) or subsection (2) of this section.]
21.
Inspectors. —(1) The Central Government or a State Government may,
by notification in the Official Gazette, appoint such person as it thinks
fit, having the prescribed qualification, to be Inspectors for such areas as
may be assigned to them by the Central Government or State Government, as the
case may be.
(2)
The
powers which may be exercised by an Inspector and the duties which may be performed
by him, the drugs or [classes of drugs or cosmetics or classes of cosmetics]
in relation to which and the conditions, limitations or restrictions subject
to which, such powers and duties may be exercised or performed shall be such
as may be prescribed.
(3)
No
person who has any financial interest [in the import, manufacture or sale of
drugs or cosmetics] shall be appointed to be an Inspector under this
section.]
(4)
Every
Inspector shall be deemed to be public servant within the meaning of section 21
of the Indian Penal Code (45 of 1860), and shall be officially subordinate to
such authority [having the prescribed qualification] as the Government
appointing him may specify in this
behalf.]
22.
Powers of Inspectors—(1) Subject to the provisions of section
23 and of any rules made by the Central Government in this behalf, an
Inspector may, within the local limits of the area for which he is appointed,
—
(a)
inspect,
--(i) any premises wherein any drug or cosmetic is being manufactured
and the means employed for standardizing and testing the drug or cosmetic;
(ii)
any
premises wherein any drug or cosmetic is being sold, or stocked or exhibited
or offered for sale, or distributed ;
(b)
take
samples of any drug or cosmetic,--
(i)
which
is being manufactured or being sold or is stocked or exhibited or offered for
sale, or is being distributed;
(ii)
from
any person who is in the course of conveying, delivering or preparing to deliver
such drug or cosmetic to a purchaser or a consignee;
(c)
at
all reasonable times, with such assistance, if any, as he considers
necessary,--
(i)
search
any person, who, he has reason to believe, has secreted about his person, any
drug or cosmetic in respect of which an offence under this Chapter has been,
or is being, committed; or
(ii)
enter
and search any place in which he has reason to believe an offence under this
Chapter has been, or is being committed; or
(iii)
stop
and search any vehicle, vessel, or other conveyance which, he has reason to
believe, is being used for carrying any drug or cosmetic in respect of which an
offence under this Chapter has been, or is being, committed, and order in
writing the person in possession of the drug or cosmetic in respect of which the
offence has been, or is being, committed, not to dispose of any stock of such
drug or cosmetic for a specified period not exceeding twenty days, or, unless
the alleged offence is such that the defect may be removed by the possessor
of the drug or cosmetic, seize the stock of such drug or cosmetic and any
substance or article by means of which the offence has been ,or is being,
committed or which may be employed for the commission of such offence;]
(cc)
examine
any record, register, document or any other material object found [with any
person, or in place, vehicle, vessel or other conveyance referred to in clause
(c)], and seize the same if he has reason to believe that it may
furnish evidence of the commission of an offence punishable under this Act or
the Rules made thereunder;]
(cca)
require
any person to produce any record, register, or other document relating to the
manufacture for sale or for distribution, stocking, exhibition for sale,
offer for sale or distribution of any drug or cosmetic in respect of which he
has reason to believe that an offence under this Chapter has been, or is
being, committed;
(d)
exercise
such other powers as may be necessary for carrying out the purposes of this
Chapter or any rules made there under.
(2)
The
provisions of the Code of Criminal Procedure, [1973 (2 of 1974)] shall, so
far as may be, apply to any search or seizure under this Chapter as they
apply to any search or seizure made under the authority of a warrant issued
under section [94] of the said Code.
(2A)
Every
record, register or other document seized under clause (cc) or
produced under clause (cca) shall be returned to the person, from whom
they were seized or who produce the same, within a period of twenty days of
the date of such seizure or production, as the case may be, after copies
thereof or extracts there from certified by that person, in such manner as
may be prescribed, have been taken.]
(3) If any person willfully obstructs an
Inspector in the exercise of the powers conferred upon him by or under this
Chapter 1[or refuses to produce any record, register or other document when
so required under clause (cca) of sub-section (1)], he shall be
punishable with imprisonment which may extend to three years, or with fine,
or with both.]
23.
Procedure of Inspectors. —(1) Where an Inspector takes any
sample of a drug [or cosmetic] under this Chapter, he shall tender the fair
price thereof and may require a written acknowledgement therefor.
(2)
Where
the price tendered under sub-section (1) is refused, or where the
Inspector seizes the stock of any drug [or cosmetic] under clause (c) of
section 22, he shall tender a receipt therefore in the prescribed form.
(3)
Where
an Inspector takes a sample of a drug [or cosmetic] for the purpose of test
or analysis, he shall intimate such purpose in writing in the prescribed form
to the person from whom he takes it and, in the presence of such person
unless he willfully absents himself, shall divide the sample into four
portions and effectively seal and suitably mark the same and permit such
person to add his own seal and mark to all or any of the portions so sealed
and marked:
Provided
that where the sample is taken from premises whereon the drug [or cosmetic]
is being manufactured, it shall be necessary to divide the sample into three
portions only:
Provided
further that where the drug [or cosmetic] is made up in containers of small volume,
instead of dividing a sample as aforesaid, the Inspector may, and if the drug
[or cosmetic] be such that it is likely to deteriorate or be otherwise
damaged by exposure shall, take three or four, as the case may be, of the
said containers after suitably marking the same and, where necessary, sealing
them.
(4)
The
Inspector shall restore one portion of a sample so divided or one container,
as the case may be, to the person from whom he takes it, and shall retain the
remainder and dispose of the same as follows: --
(i)
one
portion or container he shall forthwith send to the Government Analyst for test
or analysis;
(ii)
the
second he shall produce to the Court before which proceedings, if any, are instituted
in respect of the drug [or cosmetic];
(iii)
the
third, where taken, he shall send to the person, if any, whose name, address
and other particulars have been disclosed under section 18A.]
(5)
Where
an Inspector takes any action under clause (c) of section 22, --
(a) he shall use all despatch in ascertaining
whether or not the drug [or cosmetic] contravenes any of the provisions of
the section 18 and, if it is ascertained that the drug [or cosmetic] does not
so contravene, forthwith revoke the order passed under the said clause or, as
the case may be take , such action as may be necessary for the return of the stock
seized;
(b)
if
he seizes the stock of the drug [or cosmetic], he shall as soon as may be, inform
a [Judicial] Magistrate and take his orders as to the custody thereof;
(c)
without
prejudice to the institution of any prosecution, if the alleged contravention
be such that the defect may be remedied by the possessor of the drug [or cosmetic],
he shall, on being satisfied that the defect has been so remedied, forthwith revoke
his order under the said clause.
(6)
Where
an Inspector seizes any record, register, document or any other material object
under clause (cc) of sub-section (1) of section 22,he shall, as
soon as may be, inform a [Judicial] Magistrate and take his orders as to the
custody thereof.]
24.
Persons bound to disclose place where drugs or cosmetics are manufactured
or kept.—Every person for the time being in charge of any premises
whereon any drug [or cosmetic] is being manufactured or is kept for
sale or distribution shall, on being required by an Inspector so to
do, be legally bound to disclose to the Inspector the place where the drug
[or cosmetic] is being manufactured or is kept, as the case may be.
25.Reports
of Government Analysts. —(1) The Government Analyst to whom a
sample of any drug [or cosmetic] has been submitted for test or analysis
under sub-section (4) of section 23, shall deliver to the Inspector
submitting it a signed report in triplicate in the prescribed form.
(2)The Inspector on
receipt thereof shall deliver one copy of the report to the person from whom
the sample was taken [and 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.
(3)Any document
purporting to be a report signed by a Government Analyst under this Chapter
shall be evidence to the facts stated therein, and such evidence shall be
conclusive unless the person from whom the sample was taken [or the person
whose name, address and other particulars have been disclosed under section
18A] has, within twenty-eight days of the receipt of a copy of the report,
notified in writing the Inspector or the Court before which any proceedings
in respect of the sample are pending that he intends to adduce evidence in controversion
of the report.
(4) 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 [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.
(5)
The
cost of a test or analysis made by the Central Drugs Laboratory under
subsection (4) shall be paid by complainant or accused as the Court
shall direct.
26.
Purchaser of drugs or cosmetics enabled to obtain test or analysis.— Any
person [or any recognized consumer association, whether such person is a
member of that association or not] shall, on application in prescribed manner
and on payment of prescribed fee, be entitled to submit for test or analysis
to a Government Analyst any drug [or cosmetic] purchased by him [or it] and
to receive a report of such test or analysis signed by the Government
Analyst.
[Explanation.
—For the purposes of this section and section 32, “recognized consumer association”
means a voluntary consumer association registered under the Companies Act, 1956
or any other law for the time being in force.]
26A.
Power of Central Government to prohibit manufacture, etc., of drug and
cosmetic in public interest. —Without prejudice to any other provision
contained in this Chapter, if the Central Government is satisfied,
that the use of any drug or cosmetic is likely to involve any risk to
human beings or animals or that any drug does not have the therapeutic value
claimed or purported to be claimed for it or contains ingredients and
in such quantity for which there is no therapeutic justification and
that in the public interest it is necessary or expedient so to do,
then, that Government may, by notification in the Official Gazette, prohibit
the manufacture, sale or distribution of such drug or cosmetic]
27.
Penalty for manufacture, sale, etc., of drugs in contravention of this
Chapter. -- Whoever, himself or by any other person on his behalf,
manufactures for sale or for distribution, or sells, or stocks or
exhibits or offers for sale or distributes, —
(a)
any
drug deemed to be adulterated under section 17A or spurious under section 17B
or which when used by any person for or in the diagnosis, treatment,
mitigation, or prevention of any disease or disorder is likely to cause his
death or is likely to cause such harm on his body as would amount to grievous
hurt within the meaning of section 320 of the Indian Penal Code, solely on
account of such drug being adulterated or spurious or not of standard
quality, as the case may be, shall be punishable with imprisonment for a term
which shall not be less than five years but which may extend to a term of
life and with fine which shall not be less than ten thousand rupees;]
(b)
any
drug— (i) deemed to be adulterated under section 17A, but not being a
drug referred to in clause (a), or
(ii)
without
a valid licence as required under clause (c) of section 18, shall be
punishable with imprisonment for a term which shall not be less than one year
but which may extend to three years and with fine which shall not be less
than five thousand rupees;
Provided
that the Court may, for any adequate and special reasons to be recorded in
the judgment, impose a sentence of imprisonment for a term of less than one
year and of fine of less than five thousand rupees;
(c)
any
drug deemed to be spurious under section 17B, but not being a drug referred to
in clause (a) shall be punishable with imprisonment for a term which
shall not be less than five years and with fine which shall not be less than
five thousand rupees;
Provided
that the Court may, for any adequate and special reasons, to be recorded in
the judgment, impose a sentence of imprisonment for a term of less than three
years but not less than one year;
(d)
any
drug, other than a drug referred to in clause (a) or clause (b) or
clause (c), in contravention of any other provision of this Chapter or any
rule made thereunder, shall be punishable with imprisonment for a term which
shall not be less than one year but which may extend to two years and with
fine;
Provided
that the Court may, for any adequate and special reasons, to be recorded in
the judgment impose a sentence of imprisonment for a term of less than one
year.
27A.
Penalty for manufacture, sale, etc., of cosmetics in contravention of this
Chapter. — Whoever himself or by any other person on his behalf
manufactures for sale or for distribution, or sells, or stocks or
exhibits or offers for sale— (i) any cosmetic deemed to be spurious
under section 17D shall be punishable with imprisonment for a term
which may extend to three years and with fine;
(ii)
any
cosmetic other than a cosmetic referred to in clause (i) above in
contravention of any provision of this Chapter or any rule made thereunder
shall be punishable with imprisonment for a term which may extend to one year
or with fine which may extend to one thousand rupees or with both.]
28.Penalty
for non-disclosure of the name of the manufacturer, etc.— Whoever contravenes
the provisions of section 18A [or section 24] shall be punishable with imprisonment
for a term which may extend to one year, or with fine which may extend to [one
thousand rupees], or with both.]
28A.
Penalty for not keeping documents, etc., and for non-disclosure of
information. — Whoever without reasonable cause or excuse, contravenes the
provision of section 18B shall be punishable with imprisonment for a
term which may extend to one year or with fine which may extend to one
thousand rupees or both.
28B.Penalty
for manufacture, etc., of drugs or cosmetics in contravention of section 26A.—Whoever
himself or by any other person on his behalf manufactures or sells or
distributes any drug or cosmetic in contravention of the provisions of
any notification issued under section 26A, shall be punishable with
imprisonment for a term which may extend to three years and shall also
be liable to fine which may extend to five thousand rupees.]
29
Penalty for use of Government Analyst’s report for advertising. —Whoever
uses any report of a test or analysis made by the Central Drugs Laboratory or
by a Government Analyst, or any extract from such report, for the purpose of
advertising any drug [or cosmetic], shall be punishable with fine, which may
extend to five hundred rupees.
30.Penalty
for subsequent offences. --. (1) whoever having been convicted of
an offence- (a) under clause (b) of section 27 is again
convicted of an offence under that clause, shall be punishable with
imprisonment for a term which shall not be less than two years but which may
extend to six years with fine which shall not be less than ten thousand rupees:
Provided
that the Court may, for any adequate and special reasons to be mentioned in
the judgment, impose a sentence of imprisonment for a term of less than two
years and of fine of less than ten thousand rupees;
(b)
under
clause (c) of section 27, is again convicted of an offence under that
clause shall be punishable with imprisonment for a term which shall not be
less than six years but which may extend to ten years and with fine which
shall not be less than ten thousand rupees;
(c)
under
clause (d) of section 27, is again convicted of an offence under that
clause shall be punishable with imprisonment for a term which shall not be
less than two years but which may extend to four years or with fine which
shall not be less than five thousand rupees, or with both;]]
(1A).Whoever, having
been convicted of an offence under section 27A is again convicted under that
section, shall be punishable with imprisonment for a term which may extend to
two years, or with fine which may extend to [two thousand rupees], or with
both.]
(2)
Whoever,
having been convicted of an offence under section 29 is again convicted of an
offence under the same section shall be punishable with imprisonment which may
extend to [ten years] or with fine, or with both.]
31.
Confiscation. (1)] Where any person has been convicted under this
Chapter for contravening any such provision of this Chapter or any rule made
thereunder as may be specified by rule made in this behalf, the stock of the
drug [or cosmetic] in respect of which the contravention has been made shall
be liable to confiscation [and if such contravention is in respect of—
(i)
manufacture
of any drug deemed to be misbranded under section 17, adulterated under
section 17A or spurious under section 17B; or
(ii)
manufacture
for sale, or for distribution ,sale, or stocking or exhibiting or offering
for sale, or distribution of any drug without a valid licence as required
under clause (c) of section 18;] any implements or machinery used in
such manufacture, sale or distribution and any receptacles, packages or
coverings in which such drug is contained and the animals, vehicles, vessels
or other conveyances used in carrying such drug shall also be liable to
confiscation.]
(2)
Without
prejudice to the provisions contained in sub-section (1) where the
Court is satisfied, on the application of an Inspector or otherwise and after
such inquiry as may be necessary that the drug or cosmetic is not of standard
quality [or is misbranded, adulterated or spurious drug or misbranded or
spurious cosmetic], such drug or, as the case may be, such cosmetic shall be
liable to confiscation.]
31A.
Application of provisions to Government departments. -- The provisions
of this Chapter except those contained in section 31 shall apply in relation
to the manufacture, sale or distribution of drugs of any department of
Government as they apply in relation to the manufacture, sale or distribution
of drugs by any other person.]
32.Cognizance
of offence. —(1) No prosecution under this Chapter shall be instituted except
by an Inspector [or by the person aggrieved or by a recognised consumer
association whether such person is a member of that association or not.]
(2)
No
court inferior to that of a [Metropolitan] Magistrate or of a [Judicial]
Magistrate of the first class shall try an offence punishable under this
Chapter.
(3)
Nothing
contained in this Chapter shall be deemed to prevent any person from being prosecuted
under any other law for any act or omission which constitutes an offence
against this Chapter.
32A.Power of Court to
implead the manufacturer, etc.—Where, at any time during the trial of
any offence under this Chapter alleged to have been committed by any person,
not being the manufacturer of a drug or cosmetic or his agent for the distribution
thereof the Court is satisfied, on the evidence adduced before it, that such
manufacturer or agent is also concerned in that offence, then, the court may,
notwithstanding anything contained in [subsections (1), (2) and
(3) of section 319 of the Code of Criminal Procedure,1973 (2 of 1974)]
proceed against him as though a prosecution had been instituted against him
under section 32.]
33.[Power
of Central Government to make rules. —(1) The Central Government may after
consultation with, [or on the recommendation of,] the Board and after
previous publication by notification in the Official Gazette, make rules for
the purposes of giving effect to the provisions of this chapter:
Provided
that consultation with the Board may be dispensed with if the Central Government
is of opinion that circumstances have arisen which render it necessary to
make rules without such consultation, but in such a case the Board shall be
consulted within six months of making of the rules and the Central Government
shall take into consideration any suggestions which the Board may make in
relation to the amendment of the said rules.]
(2)
Without prejudice to the generality of the foregoing power, such rules may— (a)
provide for the establishment of laboratories for testing and analyzing
drugs [or cosmetics];
(b)
prescribed
the qualifications and duties of Government Analysts and the qualifications
of Inspectors;
(c)
prescribe
the methods of test or analysis to be employed in determining whether a drug
[or cosmetic] is of standard quality;
(d)
prescribe,
in respect of biological and organometallic compounds, the units or methods
of standardization;
(dd)
prescribe
under clause (d) of section [17A] the colour or colours which a drug
may bear or contain for purposes of colouring;]
(e) prescribe the forms of licences for the
manufacture for sale [or distribution], for the sale and for the distribution
of drugs or any specified drug or class of drugs [or of cosmetic or any
specified cosmetic or class of cosmetics], the form of application for such
licences, the conditions subject to which such licences may be issued, the
authority empowered to issue the same, [the qualification of such authority] and
the fees payable therefor [and provided for the cancellation or suspension of
such licences in any case where any provision of this Chapter or the rules
made thereunder is contravened or any of the conditions subject to which they
are issued is not complied with;]
(ee)
prescribe
the records, registers or other documents to be kept and maintained under
section 18B;
(eea)
prescribe
the fees for the inspection (for the purposes of grant or renewal of licence)
of premises, wherein any drug or cosmetic is being or is proposed to be manufactured;
(eeb)
prescribe
the manner in which copies are to be certified under sub-section (2A) of
section 22;]
(f)
specify
the diseases or ailments which a drug may not purport or claim [ to prevent,
cure or mitigate] and such other effects which a drug may not purport or claim
to have;
(g)
prescribe
the conditions subject to which small quantities of drugs may be manufactured
for the purpose of examination, test or analysis;
(h)
require
the date of manufacture and the date of expiry of potency to be clearly or
truly stated on the label or container of any specified drug or class of drugs,
and prohibit the sale, stocking or exhibition for sale, or distribution of
the said drug or class of drugs after the expiry of a specified period from
the date of manufacture or after the expiry of the date of potency;
(i)
prescribe
the conditions to be observed in the packing in bottles, packages, and other
containers of drugs 2[or cosmetics], [including the use of packing material
which comes into direct contact with the drugs]and prohibit the sale, stocking
or exhibition for sale, or distribution of drugs [or cosmetics] packed in contravention
of such conditions;
(j)
regulate
the mode of labelling packed drugs [or cosmetics], and prescribe the matter
which shall or shall not be included in such labels;
(k)
prescribe
the maximum proportion of any poisonous substance which may be added or
contained in any drug, prohibit the manufacture, sale or stocking or exhibition
for sale, or distribution of any drug in which that proportion is exceeded, and
specify substances which shall be deemed to be poisonous for the purposes of
this Chapter and the rules made thereunder;
(l)
require
that the accepted scientific name of any specified drug shall be displayed in
the prescribed manner on the label or wrapper of any patent or proprietary
medicine containing such drug;
(n)
prescribe
the powers and duties of Inspectors [and the qualifications of the authority
to which such Inspectors shall be subordinate] and [specify the drugs or classes of drugs or
cosmetics or classes of cosmetics] in relation to which and the conditions,
limitations or restrictions subject to which, such powers and duties may be
exercised or performed;]
(o)
prescribe
the forms of report to be given by Government Analysts, and the manner of
application for test or analysis under section 26 and the fees payable therefor;
(p)
specify
the offences against this Chapter or any rule made thereunder in relation to
which an order of confiscation may be made under section 31;] and (q) provide
for the exemption, conditionally or otherwise, from all or any of the provisions
of this Chapter or the rules made thereunder, of any specified drug or class
of drugs [or cosmetic or class of cosmetics];
33A.
Chapter not to apply to Ayurvedic, [Siddha] or Unani
drugs. —Save as otherwise provided in this Act, nothing contained in this
Chapter shall apply to Ayurvedic, [Siddha] or Unani drugs.]
CHAPTER
IVA
PROVISIONS
RELATING TO AYURVEDIC, [SIDDHA] AND UNANI DRUGS
33B.
Application of Chapter IVA—This Chapter shall apply only to Ayurvedic,
[Siddha] and Unani drugs.
33C.
Ayurvedic, [Siddha] and Unani Drugs Technical Advisory
Board.—(1) The Central Government shall, by notification in the Official
Gazette and with effect from such date as may be specified therein,
constitute a Board (to be called the Ayurvedic, [Siddha] and Unani Drugs
Technical advisory Board) to advise the Central Government and the State Governments
on technical matters arising out of this Chapter and to carry out the other functions
assigned to it by this Chapter
(2)
The
Board shall consist of the following members, namely: --
(i)
the
Director General of Health Services, ex officio;
(ii)
the
Drugs Controller,
(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,
(v)
one
person holding the appointment of Government Analyst under section 33F,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
Dravyaguna and Bhaishajya Kalpana, to be nominated by the Central Government;
(x)one teacher in
Ilm-Ul-Advia and Taklis-Wa-Dawa-sazi,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 system of medicine to be nominated by the Central Government.]
(3)
The
central Government shall appoint a member of the Board as its Chairman.
(4)
The
nominated members of the Board shall hold office for three years but shall be
eligible for renomination.
(5)
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.
(6)
The
functions of the Board may be exercised notwithstanding any vacancy therein.
(7)
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 the Central
Government considers necessary.
33D.
The Ayurvedic, Siddha and Unani Drugs Consultative Committee. —(1) The
Central Government may constitute an Advisory Committee to be called the
Ayurvedic, Siddha and Unani Drugs Consultative Committee to advise the
Central Government, the State Governments and the Ayurvedic, Siddha and Unani
Drugs Technical Advisory Board on any matter for the purpose of securing
uniformity throughout India in the administration of this Act in so far as it
relates to Ayurvedic, Siddha or Unani drugs.
(2)
The
Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of two
persons to be nominated by the Central Government as representatives of that
Government and not more than one representative of each State to be nominated
by the State Government concerned.
(3)
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.
33E.
Misbranded drugs. -- For the purposes of this Chapter, an Ayurvedic,
Siddha or Unani drug shall be deemed to be misbranded-- (a) if it is
so coloured, coated, powered 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 labeled in the prescribed manner; or
(c)
if
its label or container or anything accompanying the drug bears any statement,
design device which makes any false claim for the drug or which is false or
misleading in any particular.
33EE.
Adulterated Drugs. —For the purposes of this Chapter, an Ayurvedic,
Siddha or Unani 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 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 coloring 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.
Explanation. —For the
purpose of clause (a), a drug shall not be deemed to consist, in whole
or in part, of any decomposed substance only by reason of the fact that such decomposed
substance is the result of any natural decomposition of the drug:
Provided
that such decomposition is not due to any negligence on the part of manufacturer
of the drug or the dealer thereof and that it does not render the drug
injurious to health.
33EEA.
Spurious drugs. -- For the purposes of this Chapter, an Ayurvedic,
Siddha or Unani drug shall be deemed to be spurious-- (a) if it is
sold, or offered or exhibited for sale, under a name which belongs to another
drug; or
(b)
if
it is an imitation 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 of
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 any other drug or substance; or
(e)
if
it purports to be the product of a manufacturer of whom it is not truly a product.
33EEB.
Regulation of manufacture for sale of Ayurvedic, Siddha and Unani drugs.
—No person shall manufacture for sale or for distribution any Ayurvedic,
Siddha or Unani drug except in accordance with such standards, if any, as may
be prescribed in relation to that drug.
33EEC.
Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani
drug. From such date as the State Government may, by notification in the
Official Gazette, specify in this behalf, no person, either by himself
or by any other person on his behalf, shall— (a) manufacture
for sale or for distribution-- (i) any misbranded, adulterated or
spurious Ayurvedic, Siddha or Unani drugs;
(ii)
any
patent or proprietary medicine, unless there is displayed in the prescribed
manner on the label or container thereof the true list of all the ingredients
contained in it; and
(iii)
any
Ayurvedic, Siddha or Unani drug in contravention of any of the provisions of
this Chapter or any rule made thereunder;
(b)
sell,
stock or exhibit or offer for sale or for distribution, any Ayurvedic, Siddha
or Unani drug which has been manufactured in contravention of any of the
provisions of this Act, or any rule made thereunder;
(c)
manufacture
for sale or for distribution, any Ayurvedic, Siddha or Unani drug, except
under, and in accordance with the conditions of, a licence issued for such
purpose under this Chapter by the prescribed authority;
Provided
that nothing in this section apply to Vaidyas and Hakims who
manufacture Ayurvedic, Siddha or Unani drug for the use of their own
patients;
Provided
further that nothing in this section shall apply to the manufacture, subject
to the prescribed conditions, of small quantities of any Ayurvedic, Siddha or
Unani drug for the purpose of examination, test or analysis.
33EED.
Power of Central Government to prohibit manufacture, etc., of Ayurvedic, Siddha
or Unani drugs in public interest. – Without prejudice to any other
provision contained in this Chapter, if the Central Government is
satisfied on the basis of any evidence or other material available
before it that the use of any Ayruvedic, Siddha or Unani drug is likely
to involve any risk to human beings or animals or that any such drug does not
have the therapeutic value claimed or purported to be claimed for it
and that in the public interest it is necessary or expedient so to do
then, that Government may, by notification in the Official Gazette,
prohibit the manufacture, sale or distribution of such drug.]
33F.
Government Analysts. —(1) The Central Government or a State Government
may, by notification in the Official Gazette, appoint such person as it
thinks fit, having the prescribed qualification, to be Government Analysts
for such areas as may be assigned to them by the Central Government or the
State Government ,as the case may be.
(2) Notwithstanding anything contained in
sub-section(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.
(3)
No
person who has any financial interest in the manufacture or sale of any drug shall
be appointed to be a Government Analyst under this section.]
33G.
Inspectors. —(1) The Central Government or a State Government may, by notification
in the Official Gazette, appoint such persons as it thinks fit, having the
prescribed qualification, to be Inspectors for such areas as may be assigned
to them by Central Government or the State Government as the case may be.
(2)
The
powers which may be exercised by an Inspector and the duties which may be performed
by him and the conditions, limitations or restrictions subject to which such
powers and duties may be exercised or performed shall be such as may be
prescribed.
(3)
No
person who has any financial interest in the manufacture or sale of any drug
shall be appointed to be an Inspector under this section.
(4)
Every
Inspector shall be deemed to be a public servant within 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.
33H.
Application of provisions of section 22, 23, 24 and 25. —The
provisions of section 22, 23, 24 and 25 and the rules, if any, made
thereunder shall, so far as may be, apply in relation to an Inspector and a
Government Analyst appointed under this Chapter as they apply in relation to
an Inspector and a Government Analyst appointed under Chapter IV, subject to the
modification that the references to “drug” in the said section, shall be
constructed as references to “Ayurvedic, [Siddha] or Unani Drugs.”
[33I
. Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drug
in contravention of this Chapter. —Whoever himself or by any other person
on his behalf— (1) manufactures for sale or for distribution,-- (a)
any Ayurvedic, Siddha or Unani drugs--
(i)
deemed
to be adulterated under section 33EE, or
(ii)
without
a valid licence as required under clause (c) of section 33EEC, shall be
punishable with imprisonment for a term which may extend to one year and with
fine which shall not be less than two thousand rupees;
(b)
any
Ayurvedic, Siddha or Unani drug deemed to be spurious under section 33EEA,
shall be punishable with imprisonment for a term which shall not be less than
one year but which may extend to three years and with fine which shall not be
less than five thousand rupees:
Provided
that the Court may, for any adequate and special reasons to be mentioned in
thejudgment, impose a sentence of imprisonment for a term of less than one
year and of fine of less than five thousand rupees; or
(2)
contravenes
any other provisions of this Chapter or of section 24 as applied by section
33H or any rule made under this Chapter, shall be punishable with imprisonment
for a term which may extend to three months and with fine which shall not be
less than five hundred rupees.
33J.
Penalty for subsequent offences. —Whoever being convicted of an
offence, -- (a) under clause (a) of sub-section (1) of
section 33I is again convicted of an offence under that clause, shall be
punishable with imprisonment for a term which may extend to two thousand
rupees;
(b)
under
clause (a) of sub-section (1) of section 33I is again convicted
of an offence under that clause, shall be punishable with imprisonment for a
term which shall not be less than two years but which may extend to six years
and with fine which shall not be less than five thousand rupees;
Provided
that the Court may, for any adequate or special reasons to be mentioned in
the judgment, impose a sentence of imprisonment for a term of less than two
years and of fine of less than five thousand rupees;
(c)
under
sub-section (2) of section 33-I is again convicted of an offence under
that sub-section , shall be punishable with imprisonment for a term which may
extend to six months and with fine which shall not be less than one thousand
rupees.]
33K.
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.
33L.
Application of provisions to Government departments.-- The provisions
of this Chapter except those contained in section 33K 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.
33M.
Cognizance of offences. —(1) No prosecution under this Chapter
shall be instituted except by an Inspector [with the previous sanction of the
authority specified under sub-section (4) of section 33G.]
33N.
Power of Central Government to make rules. —(1) The Central Government
may, [ after consultation with, or on the recommendation of, the Board] and
after previous publication by notification in the Official Gazette, make
rules for the purpose of giving effect to the provisions of this Chapter:
Provided
that consultation with the Board may be dispensed with if the Central Government
is of opinion that circumstances have arisen which render it necessary to
make rules without such consultation, but in such a case, the Board shall be
consulted within six months of the making of the rules and the Central
Government shall take into consideration any suggestions which the Board may
make in relation to the amendment of the said rules.
(2)
Without
prejudice to the generality of the foregoing power, such rules may-
(a)
provide
for the establishment of laboratories for testing and analyzing Ayurvedic, [Siddha]
or Unani drugs;
(b)
prescribe
the qualification and duties of Government Analysts and the qualifications of
Inspectors;
(c)
prescribe
the methods of test or analysis to be employed in determining whether any
Ayurvedic, [Siddha] or Unani drug is labelled with the true list of the
ingredients which it is purported to contain;
(d)
specify
any substance as a poisonous substance;
(e)
prescribe
the forms of licences for the manufacture for sale of Ayurvedic, [Siddha] or
Unani drugs, [and for sale of processed Ayurvedic, Siddha or Unani drugs,]
the form of application for such licences, the conditions subject to which such
licences may be issued, the authority empowered to issue the same and the
fees payable therefor; [and provide for the cancellation or suspension of
such licences in any case where any provision of this Chapter or rules made
thereunder is contravened or any of the conditions subject to which they are
issued is not complied with;]
[(f)
prescribe the conditions to be observed in the packing of Ayurvedic,
Siddha and Unani drugs including the use of packing material which comes into
direct contact with the drugs, regulate the mode of labelling packed drugs
and prescribe the matters which shall or shall not be included in such
labels;]
(g)
prescribe
the conditions subject to which small quantities of Ayurvedic [Siddha] or
Unani drugs may be manufactured for the purpose of examination, test or analysis;
and
[(gg)
prescribe under clause (d) of section 33EE the colour or colours which an
Ayurvedic, Siddha or Unani drug may bear or contain for purposes of
colouring;
(gga)
prescribe
the standards for Ayurvedic, Siddha or Unani drugs under section 33EEB;]
(h)
any
other matter which is to be or may be prescribed under this Chapter.
33O.
Power to amend First Schedule. —The Central Government, after
consultation with the Board and after giving, by notification in the Official
Gazette, not less than three months’ notice of its intention so to do, may,
by a like notification, add to or otherwise amend the First Schedule for the
purposes of this Chapter and thereupon the said Schedule shall be deemed to
be amended accordingly.
CHAPTER
V
MISCELLANEOUS
[333P.
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 madethereunder.]
34.
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.
(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:
Explanation.
—For
the purposes of this section-- (a) “company” means a body corporate,
and includes a firm or other association of individuals; and (b) “director”
in relation to a firm means a partner in the firm.
[34A.
Offences by Government departments. Where an offence under Chapter1V
or Chapter 1VA has been committed by any department of Government, such
authority as is specified by the Central Government to be in charge of
manufacture, sale or distribution of drugs or where no authority is
specified, the head of the department, 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 section shall render any such authority or
person liable to any punishment provided in Chapter1V or Chapter 1VA, as the
case may be, if such authority or person proves that the offence was
committed without its or his knowledge or that such authority or person
exercised all due diligence to prevent the commission of such offence.]
[34AA.
Penalty vexatious search or seizure. Any Inspector exercising powers
under this Act or the rules made thereunder, who,-- (a) without
reasonable ground of suspicion searches any place, vehicle, vessel or
other
conveyance; or
(b)
vexatiously
and unnecessarily searches any person; or
(c)
vexatiously
and unnecessarily seizes any drug or cosmetic, or any substance or article,
or any record, register, document or other material object; or
(d)
commits,
as such Inspector, any other act, to the injury of any person without having
reason to believe that such act is required for the execution of his duty,
shall be punishable with fine which may extend to one thousand rupees.]
35.
Publication of sentences passed under this Act. (1) If any person is
convicted of an offence under this Act, [ the court before which the
conviction takes place shall, on application made to it by the Inspector,
cause] the offender’s name, place of residence, the offence of which he has
been convicted and the penalty which has been inflicted upon him, to be
published at the expense of such person in such newspapers or in such other
manner as the Court may direct.
(2)
The
expenses of such publication shall be deemed to form part of the cost
relating to the conviction and shall be recoverable in the same manner as
those costs are recoverable.
36.
Magistrate’s power to impose enhanced penalties. — Notwithstanding
anything contained [the Code of Criminal Procedure, 1973,] it shall be lawful
for any [Metropolitan Magistrate or any Judicial Magistrate of the first
class] to pass any sentence authorized by this Act in excess of his powers
under the said Code.
[36A.
Certain offences to be tried summarily. —Notwithstanding anything
contained in the Code of Criminal Procedure, 1973, all offences under this
Act, punishable with imprisonment for a term not exceeding three years, other
than an offence under clause (b) of sub-section (1) of section
33I, shall be tried in a summary way by a Judicial Magistrate of the
first
class specially empowered in this behalf by the State Government or by a
Metropolitan Magistrate and the provisions of section 262 to265 (both
inclusive) of the said Code shall, as far as may be, apply to such trial:
Provided
that, in the case of any conviction in a summary trial under this section, it
shall be lawful for the Magistrate to pass a sentence of imprisonment for a
term not exceeding one year:
Provided
further that when at the commencement of, or in the course of, a summary trial
under this section, it appears to the Magistrate that the nature of the case
is such that a sentence of imprisonment for a term exceeding one year may
have to be passed or that it is, for any other reason, undesirable to try the
case summarily, the Magistrate shall, after hearing the parties, record an
order to that effect and thereafter recall any witness who has been examined
and proceed to hear or rehear the case in the manner provided by the said
Code.]
37.
Protection of action taken in good faith. —No suit, prosecution or
other legal proceeding shall lie against any person for anything which is in
good faith done or intended to be done under this Act.
[38.
Rules to be laid before Parliament. —Every rule made under this Act
shall be laid as soon as may be after it is made before each House of
Parliament while it is in session for a total period of thirty days which may
be comprised in one session or in two or more successive sessions, [and if,
before the expiry of the session immediately following the session or the
successive sessions aforesaid], both Houses agree in making any modification in
the rule or both Houses agree that the rule should not be made, the rule
shall thereafter have effect only in such modified from or be of no effect,
as the case may be, so however that any such modification or annulment shall
be without prejudice to the validity of anything previously done under that
rule.]
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Sunday, 15 June 2014
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