(1)
The Central
Government shall, as soon as may be, establish 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 [2] [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; [3] [***] (d) the
procedure for the submission of the said Laboratory[4]
[under Chapter IV or Chapter IVA] of samples of drugs [5] [or cosmetics]
for analysis or test, the forms of the 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 purposes of the proviso to
sub-section (1). [STATE AMENDMENTS [Uttar Pradesh [6] [In Section 6 In sub-section (i) 'after the existing proviso, the
following further proviso shall be added, namely: -- "Provided further that the State Government may,
with the prior approval of the Central Government, direct that the functions of
the Central Drugs Laboratory
and of the Director may be carried out in Uttar Pradesh by such Authority and
such officer respectively as may be specified by the State Government by
notification in the Official Gazette, and any reference in this Act to the Central Drugs Laboratory or the Director
shall then be construed as a reference to such Authority or officer, as the
case may be.".] (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 the drug [7] [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)
[8] [For the purposes of section 18 a drug shall not be deemed to be
misbranded or
[9] [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
the manufacture or preparation of the drug [10] [or cosmetic] as an article of commerce in astate fit
for carriage or consumption, and not to increase the bulk, weight or measure of
the drug [11] [or cosmetic] or to conceal its inferior quality or
other defects; or [12] [***] (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[13]
[or cosmetic] occurring after the vendor or distributor became aware of such
intermixture. [14] [(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] [STATE AMENDMENTS [Uttar Pradesh [15] [After Section 19 The following section shall be inserted, namely: -- "19-A. Burden of proof.-- When any drug or cosmetic is seized from any person
under clause (c) of section 22 by an Inspector in the reasonable belief that
such drug or cosmetic is misbranded or adulterated, the burden of proving that
such drug or cosmetic is not misbranded or adulterated shall be on the person
from whose possession such drug or cosmetic was seized.".] [16] [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 [17]
[17B and 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 (45 of 1860), solely on account of such drug being adulterated or
spurious or not of standard quality, as the case may be, shall be [18] [punishable
with imprisonment for a term which shall not be less than ten years but which
may extend to imprisonment for life and shall also be liable to fine which
shall not be less than ten lakh rupees or three times value of the drugs confiscated, whichever is more:] [19] [Provided that the fine imposed on and released
from, the person convicted under this clause shall be paid, by way of
compensation, to the person who had used the adulterated or spurious drugs referred to in this clause: Provided further that where the use of the
adulterated or spurious drugs referred to
in this clause has caused the death of a person who used such drugs, the fine imposed on and realised from, the person
convicted under this clause, shall be paid to the relative of the person who
had died due to the use of the adulterated or spurious drugs referred to in this clause. Explanation.--For the purposes of the second proviso,
the expression "relative" means-- (i) spouse of the deceased person; or (ii) a minor legitimate son, and unmarried legitimate daughter and a widowed
mother; or (iii) parent of the minor victim; or (iv) if wholly dependent on the earnings of the deceased person at the time
of his death, a son or a daughter who has attained the age of eighteen years;
or (v) any person, if wholly or in part, dependent on the earnings of the
deceased person at the time of his death,-- (a)
the parent; or (b)
a minor brother or an
unmarried sister; or (c)
a widowed
daughter-in-law; or (d)
a widowed sister; or (e)
a minor child of a
pre-deceased son; or (f)
a minor child of a pre-deceased
daughter where no parent of the child is alive; or (g)
the paternal
grandparent if no parent of the member is alive;] (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 [20]
[not be less than three years but which may extend to five years and with fine
which shall not be less than one lakh rupees or three times the value of
the drugs confiscated, whichever is more:] 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 [21]
[less than three years and of fine of less than one lakh 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 [22] [not
less than seven years but which may extend to imprisonment for life and with
fine which shall not be three lakh rupees or three times the value of the drugs confiscated, whichever is more:] 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 [23] [less
than seven years but not less than three years and of fine of less than one
lakh rupees]; (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 [24] [and
with fine which shall not be less than twenty 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. [STATE AMENDMENTS [Uttar Pradesh [25] [In Section 27 The following section shall be substituted, namely: -- "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, sells, stocks or exhibits for sale or distributes-- (a)
any drug-- (i) ???deemed
to be misbranded under clause (a), clause (b), clause (c), clause (d), clause
(f) or clause (2) of section 17 or adulterated under section 17-B, or (ii) ??without a valid licence as required under
clause (c) of section 18; or (b)
any drug other than a
drug referred to in clause (a) in contravention of any of the provisions of
this Chapter or any rule made there under-- "shall be punished with imprisonment for life: Provided that the Court may, for any special reasons
to be recorded in writing impose a sentence of imprisonment which is less than imprisonment
for life.".] [26] [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-- [27] [(i) any cosmetic deemed to be spurious under section 17D or
adulterated under section 17E shall be punishable with imprisonment for a term
which may extend to three years and with fine which shall not be less than
fifty thousand rupees or three times the value of the cosmetics confiscated, whichever
is more; (ii) ? any cosmetic other than a cosmetic referred
to in clause (i) in contravention of any provisions of this Chapter or any rule
made there under shall be punishable with imprisonment for a term which may
extend to one year or with fine which may extend to twenty thousand rupees, or
with both.] [STATE AMENDMENTS [Uttar Pradesh [28] [In Section 27-A The following section shall be substituted, namely: -- "27-A. Penalty for manufacture, sale, etc.,
of cosmetics in
contravention of this Chapter: Whoever himself or by any other persons on his behalf
manufacture for sale, sells, stocks or exhibits for sale, or distributes any
cosmetic in contravention of any provisions of this Chapter or any rule made
there under, shall be punishable with imprisonment for life and shall also be
liable to fine: Provided that the Court may, for adequate and special
reasons to be mentioned in the judgment, impose a sentence of imprisonment
which is less than imprisonment for life.".] [29] [30. Penalty for subsequent offences [30] [(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 [31]
[not be less than seven years but which may extend to ten years and with fine
which shall not be less than two lakh 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 [32]
[less than seven years and of fine of less than one lakh 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 [33]
[shall not be less than ten years but which may extend to imprisonment for life
and with fine which shall not be less than three lakh 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 [34] [fifty
thousand rupees], or with both.] [35] [(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 [36] [two
thousand rupees], or with both.] (2) Whoever,
having been convicted of an offence under [37] [*
* *] section 29 is again convicted of an offence under the same section, shall
be punishable with imprisonment which may extend to [38] [two
years, or with fine which shall not be less than ten thousand rupees or with
both.] [STATE AMENDMENTS [Uttar Pradesh [39] [In Section 30 The following section shall be substituted, namely:-- "30. All offences punishable under this Chapter
shall be cognizable and non-bailable."] [1]
Inserted by Act 21 of 1962, Section 5 (w.e.f. 27-7-1964). [2]
Inserted by Act 21 of 1962, Section 5 (w.e.f. 27-7-1964). [3]
Clauses (b) and (c) omitted by Act 11 of 1955, Section 4 (w.e.f.
15-4-1955). [4]
Substituted by Act 13 of 1964, Section 5, for "under Chapter IV"
(w.e.f. 15-9-1964). [5]
Inserted by Act 21 of 1962, Section 5 (w.e.f. 27-7-1964). [6]
Added by Prevention of Adulteration of Food, Drugs and Cosmetics (Uttar Pradesh
Amendment) Act, 1974. [7]
Inserted by Act 21 of 1962, Section 15 (w.e.f. 27-7-1964). [8]
Substituted by Act 13 of 1964, Section 15, for certain words (w.e.f.
15-9-1964). [9]
Substituted by Act 68 of 1982, Section 16, for "adulterated"
(w.e.f. 1-2-1983). [10]
Inserted by Act 21 of 1962, Section 15 (w.e.f. 27-7-1964). [11]
Inserted by Act 21 of 1962, Section 15 (w.e.f. 27-7-1964). [12]
Clause (aa) Inserted by Act 11 of 1955, Section 10 (w.e.f. 15-4-1955) and omitted
by Act 13 of 1964.
Section 15 (w.e.f. 15-9-1964). [13]
Inserted by Act 21 of 1962, Section 15 (w.e.f. 27-7-1964). [14]
Substituted by Act 13 of 1964, Section 15, for sub-section (3) (w.e.f.
15-9-1964). [15]
Clause (aa) Inserted by Act 11 of 1955, Section 10 (w.e.f. 15-4-1955) and omitted
by Act 13 of 1964.
Section 15 (w.e.f. 15-9-1964). [16]
Section 27 Substituted by Act 13 of 1964, Section 18 (w.e.f. 15-9-1964) and again
Substituted by Act 68
of 1982, Section 22 (w.e.f. 1-2-1983). [17]
Substituted by the drug and cosmetics (amendment) act 2008 dated 05.12.2008 for the
figures, letter and words "17B or which". [18]
Substituted by the drug and cosmetics (amendment) act 2008 dated 05.12.2008 for the
words "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;". [19]
Inserted by the drug and cosmetics (amendment) act 2008 dated 05.12.2008. [20]
Substituted by the drug and cosmetics (amendment) act 2008 dated 05.12.2008 for the
words "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". [21]
Substituted by the drug and cosmetics (amendment) act 2008 dated 05.12.2008 for the
words "less than one year and of fine of less than five thousand
rupees". [22]
Substituted by the drug and cosmetics (amendment) act 2008 dated 05.12.2008 for the
words "not be less than three years but which may extend to five years and
with fine which shall not be less than five thousand rupees". [23]
Substituted by the drug and cosmetics (amendment) act 2008 dated 05.12.2008 for the
words "less than three years but not less than one year". [24]
Substituted by the drug and cosmetics (amendment) act 2008 dated 05.12.2008 for the
words "and with fine". [25]
Substituted by Prevention of Adulteration of
Food, Drugs and Cosmetics (Uttar Pradesh
Amendment) Act, 1974. [26]
Section 27A Inserted by Act 21 of 1962, Section 19 (w.e.f. 27-7-1964) and Substituted
by Act 68 of 1982,
Section 22 (w.e.f. 1-2-1983). [27]
Substituted by the Drugs and Cosmetics (Amendment) Act, 2008 for the following :- "(i) any cosmetic deemed to be spurious under section 17C 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 provisions 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]
Substituted by Prevention of Adulteration of
Food, Drugs and Cosmetics (Uttar Pradesh
Amendment) Act, 1974. [29]
Substituted by Act 11 of 1955, Section 14, for section 30 (w.e.f.
15-4-1955). [30]
Substituted by Act 68 of 1982, Section 25, for sub-section (1) (w.e.f.
1-2-1983). 3. Inserted by Act 21
of 1962, Section 20 (w.e.f. 27-7-1964). [31]
Substituted by the drug and cosmetics (amendment) act 2008 for the words "not
be less than two years but which may extend to six years and with fine which
shall not be less than ten thousand rupees". [32]
Substituted by the drug and cosmetics (amendment) act 2008 for the words "less
than two years and of fine of less than ten thousand rupees". [33]
Substituted by the drug and cosmetics (amendment) act 2008 for the words
"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". [34]
Substituted by the drug and cosmetics (amendment) act 2008 for the words "five
thousand rupees". [35]
Inserted by Act 21 of 1962, Section 20 (w.e.f. 27-7-1964). [36]
Substituted by Act 68 of 1982, Section 25, for "one thousand
rupees" (w.e.f. 1-2-1983). [37]
The words "'section 28 or" omitted by Act 13 of 1964, Section 20
(w.e.f. 15-9-1964). 6. Substituted by Act 13
of 1964, Section 20, for "two years" (w.e.f. 15-9-1964). [38]
Substituted by the drug and cosmetics (amendment) act 2008 for the words
"6[ten years], or with fine, or with both.]". [39]
Substituted by Prevention of Adulteration of
Food, Drugs and Cosmetics (Uttar Pradesh
Amendment) Act, 1974.DRUGS AND COSMETICS ACT, 1940 (UTTAR PRADESH
AMENDMENT)