16. Standards of quality. —4
[(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 5
[the Second
Schedule], and
(b) in relation to a cosmetic, that the cosmetic complies with such stand ard as may
be prescribed.]
(2) The 6
[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 5
[the Second Schedule] for the purposes
of this Chapter, and thereupon 5
[the Second Schedule] shall be deemed to be amended
accordingly.
7
[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 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.
1. Ins. by Act 21 of 1962, s. 11 (w.e.f. 27-7-1964).
2. Subs. by Act 68 of 1982, s. 11, for certain words (w.e.f. 1-2-1983).
3. Subs. by s. 12, ibid., for “DRUGS” (w.e.f. 1-2-1983).
4. Subs. by Act 21 of 1962, s. 12, for sub-section (1) (w.e.f. 27-7-1964).
5. Subs. by Act 13 of 1964, s. 11, for “the Schedule” (w.e.f. 15-9-1964).
6. Subs. by Act 11 of 1955, s. 8, for “State Government”.
7. Subs. by Act 68 of 1982, s. 13, for sections 17, 17A and 17B (w.e.f. 1-2-1983).
15
17A. 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.
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 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 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) if the label or 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 imitation of, or 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 and conspicuously marked so as to re veal 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.]
16
1
[17E. Adulterated cosmetics. — For the purposes 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 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.]
18. Prohibition of manufacture and sale of certain drugs and cosmetics.—From such 2
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) 3
[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or
distribute—
4
[(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious;
5
[(ii) any cosmetic which is not of a standard quality or is misbranded, adulterated or
spurious;]]
6
[(iii) any patent or proprietary medicine, unless there is displayed in the prescribed
manner on the label or container thereof 3
[the true formula or list of active ingredients
contained in it together with the quantities thereof];]
(iv) any drug which by means of any statement design or device accompanying it or
by any other means, purports or claims 7
[to prevent, cure or mitigate] any such disease or
ailment, or to have any such other effect as may be prescribed;
8
[(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) 3
[sell or stock or exhibit or offer for sale,] or distribute any drug 9
[or cosmetic] which has been
been imported or manufacutred in contravention of any of the provisions of this Act or any rule made
thereunder;
(c) 3
[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,]
or distribute any drug 9
[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
conditions, of small quantities of any drug for the purpose of examination, test or analysis :
Provided further that the 10[Central Government] may, after consultation with the Board, by
notification in the Official Gazette, permit, subject to any conditions specified in the notifica tion,
the 11[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.
1. Ins. by Act 26 of 2008, s. 2 (w.e.f. 10-8-2009).
2. 1st April, 1947 for sub-clauses (i), (ii), (iv) and (v) of cl. (a) and cls. (b) and (c); 1st April, 1949 for sub-clause (iii) of
cl. (a) in so far as it takes effect in Delhi, Ajmer and Coorg, see Notifn. No. 18-12-46-D, II, dated 11th February, 1947, Gazette of
India, 1947, Pt. I, p. 189, as amended by notifn. No. F. 1-2/48-D (ii), dated 29th September, 1948; 1st April, 1953 for the States of
H. P., Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur, vide notifn. No. S.R.O. 664, dated the 30th March, 1953,
Gazette of India, 1953, Pt. II, Sec. 3, p. 451
3. Subs. by Act 68 of 1982. s. 14, for certain words (w.e.f. 1-2-1983).
4. Subs. by s. 14, ibid, for cls. (i), (ii) and (iia) (w.e.f. 1-2-1983).
5. Subs. by Act 26 of 2008, s. 3, for sub-clause (ii) (w.e.f.10-8-2009).
6. Subs. by Act 11 of 1955, s. 9, for sub-clause (iii).
7. Subs by s. 9, ibid., for “to cure or mitigate”.
8. Subs. by Act 21 of 1962, s. 14, for sub-clause (v) (w.e.f. 27-7-1964).
9. Ins. by s. 14, ibid. (w.e.f. 27-7-1964).
10. Subs. by Act 11 of 1955, s. 9, for “State Government”.
11. Subs. by Act 68 of 1982, s. 14, for “manufacture for sale, sale” (w.e.f. 1-2-1983).
17
1
* * * * *
2
[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.]
3
[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, sub stance
or quality of the drug 4
[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) 5
[For the purposes of section 18 a drug shall not be deemed to be misbranded or
6
[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 4
[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 4
[or cosmetic] or to conceal its inferior quality or other defects; or
7
* * * * *
(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 4
[or cosmetic] occurring after the vendor or
distributor became aware of such intermixture.
8
[(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 a nd
remained in the same state as when he acquired it.]
1. The Explanation omitted by Act 68 of 1982, s. 14 (w.e.f. 1-2-1983).
2. Ins. by Act 13 of 1964, s. 14 (w.e.f. 15-9-1964).
3. Ins. by Act 68 of 1982, s. 15 (w.e.f. 1-2-1983).
4. Ins. by Act 21 of 1962, s. 15 (w.e.f. 27-7-1964).
5. Subs. by Act 13 of 1964, s. 15, for certain words (w.e.f. 15-9-1964).
6. Subs. by Act 68 of 1982, s. 16, for “adulterated” (w.e.f. 1-2-1983).
7. Cl. (aa) ins. by Act 11 of 1955, s. 10, omitted by Act 13 of 1964, s. 15 (w.e.f. 15-9-1964).
8. Subs. by Act 13 of 1964, s. 15, for sub-section (3) (w.e.f. 15-9-1964).
18
1
[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 2
[classes of
drugs or such cosmetics or classes of cosmetics] as may be specified in the notification.
(2) The Central Government may also, by notification in the Official Gaz ette, appoint such
persons as it thinks fit, having the prescribed qualifications, to be Government Analysts in
respect of such drugs or 2
[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 und er which he
is serving.
3
[(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 sub-section (2) of
this section.]
21. 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 qualifications, to be Inspectors for such areas as may be assigned to them by the
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, the drugs or 4
[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 5
[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 a public servant within the meaning of
section 21 of the Indian Penal Code (45 of 1860), and shall be officially subordinate to such
authority
6
[having the prescribed qualifications,] as the Government appointing him may
specify in this behalf.]
7
[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,—
8
[(a) inspect,—
(i) any premises wherein any drug or cosmetic is being manufactured and the
means employed for standardising 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;
1. Subs by Act 35 of 1960, s. 4, for the original sections 20 and 21 (w.e.f. 16-3-1961).
2. Subs. by Act 21 of 1962, s. 16, for “class of drugs” (w.e.f. 27-7-1964).
3. Ins. by Act 68 of 1982, s. 17 (w.e.f. 1-2-1983).
4. Subs. by Act 21 of 1962, s. 17, for “class of drugs” (w.e.f. 27-7-1964).
5. Subs. by s. 17, ibid., for “in the manufacture, import or sale of drugs” (w.e.f. 27-7-1964).
6. Ins. by Act 68 of 1982, s. 18 (w.e.f. 1-2-1983).
7. Subs. by Act 11 of 1955, s. 11, for s. 22.
8. Subs. by Act 68 of 1982, s. 19, for cls. (a), (b) and (c) (w.e.f. 1-2-1983).
19
(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 that 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 dru g 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;]
1
[(cc) examine any record, register, document or any other material object found 2
[with
any person, or in any 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;]
3
[(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 thereunder.
(2) The provisions of 4
[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 5
[section 94] of the said Code.
3
[(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
1. Ins. by Act 35 of 1960, s. 5 (w.e.f. 16-3-1961).
2. Subs. by Act 68 of 1982, s. 19, for certain words (w.e.f. 1-2-1983).
3. Ins. by s. 19, ibid. (w.e.f. 1-2-1983).
4. Subs. by s. 19, ibid., for “the Code of Criminal Procedure, 1898” (w.e.f. 1-2-1983).
5. Subs. by s. 19, ibid., for “section 98” (w.e.f. 1-2-1983).
20
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 therefrom certified by that person, in such manner as may be
prescribed, have been taken.]
(3) If any person wilfully 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 2
[or
cosmetic] under this Chapter, he shall tender the fair price thereof and may require a written
acknowledgment therefor.
(2) Where the price tendered under sub-section (1) is refused, or where the Inspector seizes
the stock of any drug 2
[or cosmetic] under clause (c) of section 22, he shall tender a receipt
therefor in the prescribed form.
(3) Where an Inspector takes a sample of a drug 2
[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 wilfully 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 2
[or cosmetic]
is being manufactured, it shall be necessary to divide the sample into three portions only:
Provided further that where the drug 2
[or cosmetic] is made up in containers of small
volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug 2
[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 ma rking 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 2
[or cosmetic]; and
3
[(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 2
[or cosmetic];
contravenes any of the provisions of section 18 and, if it is ascertained that the drug 2
[or
cosmetic]; does not so contravene, forthwith revoke the order passed under the sa id
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 2
[or cosmetic]; he shall as soon as may be inform 4
[a Judicial
Magistrate] and take his orders as to the custody thereof;
1. Ins. by Act 68 of 1982, s. 19 (w.e.f. 1-2-1983).
2. Ins. by Act 21 of 1962, s. 15 (w.e.f. 27-7-1964).
3. Subs. by Act 13 of 1964, s. 16, for cl. (iii) (w.e.f. 15-9-1964).
4. Subs. by Act 68 of 1982, s. 20, for “a Magistrate” (w.e.f. 1-2-1983).
21
( 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 1
[or cosmetic]; he shall, on being
satisfied that the defect has been so remedied, forthwith revoke his order under the said clause.
2
[(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 3
[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 1
[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 1
[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 1
[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 4
[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 of the facts stated therein, and such evidence shall be conclusive
unless the person from whom the sample was taken 5
[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
1
[or cosmetic] produced before the Magistrate under sub-section (4) of section 23 to be sent for
test or analysis to the said Laboratory, which shall make the test or analysis and report in
writing signed by or under the authority of, the Director of the Central Drugs Laboratory the
result thereof, and such report shall be conclusive evidence of the facts stated therein.
(5) The cost of a test or analysis made by the Central Drugs Laboratory under
sub-section (4) shall be paid by the complainant or accused as the Court shall direct.
26. Purchaser of drug or cosmetic enabled to obtain test or analysis.—Any person
6
[or any recognised consumer association, whether such person is a member of that association
or not,] shall, on application in the prescribed manner and on payment of the prescribed fee, be
entitled to submit for test or analysis to a Government Analyst any drug 1
[or cosmetic]
7
[purchased by him or it] and to receive a report of such test or analysis signed by the
Government Analyst.
1. Ins. by Act 21 of 1962, s. 15 (w.e.f. 27-7-1964).
2. Ins. by Act 35 of 1960, s. 6 (w.e.f. 16-3-1961).
3. Subs. by Act 68 of 1982, s. 20, for “a Magistrate” (w.e.f. 1-2-1983).
4. Subs. by Act 13 of 1964, s. 17, for certain words (w.e.f. 15-9-1964).
5. Subs. by s. 17, ibid., for “or the said warrantor” (w.e.f. 15-9-1964).
6. Ins. by Act 71 of 1986, s. 2 (w.e.f. 15-9-1987).
7. Subs. by s. 2, ibid., for “purchased by him” (w.e.f. 15-9-1987).
22
1
[Explanation.—For the purposes of this section and section 32, “recognised consumer association
means a voluntary consumer association registered under the Companies Act, 1956 (1 of 1956) or any
other law for the time being in force.]
2
[26A. Powers of Central Government to 3
[regulate, restrict or 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, 3
[regulate, restrict or prohibit] the
manufacture, sale or distribution of such drug or cosmetic.]
4
[26B. Power of Central Government to regulate or restrict, manufacture, etc., of drug in
public interest. —Without prejudice to any other provision contained in this Chapter, if the Central
Government is satisfied that a drug is essential to meet the requirements of an emergency arising due to
epidemic or natural calamities and that in the public interest, it is necessary or expedient so to do, then,
that Government may, by notification in the Official Gazette, regulate or restrict the manufacture, sale or
distribution of such drug.]
5
[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 6
[17B
and which] when used by any person for or in the diagnosis, treatment, mitigation, or pre -
vention 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 grevious 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 7
[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]:
8
[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
1. Ins. by Act 71 of 1986, s. 2 (w.e.f. 15-9-1987).
2. Ins. by Act 68 of 1982. s. 21 (w.e.f. 1-2-1983).
3. Subs. by Act 26 of 2008, s. 4, for “prohibit” (w.e.f. 10-8-2009).
4. Ins. by s. 5, ibid. (w.e.f. 10-8-2009).
5. Subs. by Act 68 of 1982, s. 22, for sections 27 and 27A (w.e.f. 1-2-1983).
6. Subs. by Act 26 of 2008, s. 6, for “17B or which” (w.e.f. 10-8-2009).
7. Subs. by s. 6, ibid., for “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;” (w.e.f. 10-8-2009).
8. The provisos ins. by s. 6, ibid. (w.e.f. 10-8-2009).
23
(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 1
[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 2
[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 3
[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 4
[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 5
[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.
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—
6
[(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;
1. Subs. by Act 26 of 2008, s. 6, for “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” (w.e.f. 10-8-2009).
2. Subs. by s. 6, ibid., for “less than one year and of fine of less than five thousand rupees” (w.e.f. 10-8-2009).
3. Subs. by s. 6, ibid., for “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” (w.e.f. 10-8-2009).
4. Subs. by s. 6, ibid., for “less than three years but not less than one year” (w.e.f. 10-8-2009).
5. Subs. by s. 6, ibid., for “and with fine” (w.e.f. 10-8-2009).
6. Subs. by s. 7, ibid., for clauses (i) and (ii) (w.e.f. 10-8-2009).
24
(ii) any cosmetic other than a cosmetic referred to in clause (i) 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 twenty thousand rupees, or with both. ]]
1
[28. Penalty for non-disclosure of the name of the manufacturer, etc.—Whoever
contravenes the provisions of section 18A 2
[or section 24] shall be punishable with
imprisonment for a term which may extend to one year, or 3
[with fine which shall not be less
than twenty thousand rupees or with both].]
4
[28A. Penalty for not keeping documents, etc., and for non-disclosure of
information.—Whoever without reasonable cause or excuse, contravenes the provisions of
section 18B shall be punishable with imprisonment for a term which may extend to one year or
3
[with fine which shall not be less than twenty thousand rupees or with 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 5
[or cosmetic], shall be
punishable with fine which may extend to 6
[five thousand rupees].
7
[30. Penalty for subsequent offences.— 8
[(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 9
[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 10[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 11[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 12[fifty thousand rupees], or
with both.]
1. Subs, by Act 13 of 1964, s. 19, for s. 28 (w.e.f. 15-9-1964).
2. Ins. by Act 68 of 1982, s. 23 (w.e.f. 1-2-1983).
3. Subs. by Act 26 of 2008, s. 8, for “with fine which may extend to one thousand rupees or with both” (w.e.f. 10-8-2009).
4. Ins. by Act 68 of 1982 s. 24 (w.e.f. 1-2-1983).
5. Ins. by Act 21 of 1962, s. 15 (w.e.f. 27-7-1964).
6. Subs. by Act 26 of 2008, s. 10, for “five hundred rupees” (w.e.f. 10-8-2009).
7. Subs. by Act 11 of 1955, s. 14, for s. 30.
8. Subs. by Act 68 of 1982, s. 25, for sub-section (1) (w.e.f. 1-2-1983).
9. Subs. by Act 26 of 2008, s. 11 for “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”(w.e.f. 10-8-2009).
10. Subs. by s. 11, ibid., for “less than two years and of fine of less than ten thousand rupees (w.e.f. 10-8-2009).
11. Subs. by s. 11, ibid., for “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” (w.e.f. 10-8-2009).
12. Subs. by s. 11, ibid., for “five thousand rupees” (w.e.f. 10-8-2009).
25
1
[(1A) Whoever, having been convicted of an offence under section 27A is again convicted
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 2
[two thousand rupees], or with both.]
(2) Whoever, having been convicted of an offence under 3
*** section 29 is again convicted of an
offence under the same section shall be punishable with imprisonment which may extend to 4
[two
years, or with fine which shall not be less than ten thousand rupees or with both.]]
31. Confiscation. — 5
[(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 6
[or cosmetic] in respect of which
the contravention has been made shall be liable to confiscation 7
[and if such contravention is in
in respect of—
8
[(i) manufacture of any drug deemed to be misbranded under section 17, adulterated under
section 17A or spurious under section 17B; or]
(ii)
9
[manufacture for sale, or for distribution, sale, or stocking, or exhibiting or offering
ing 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].
10[(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 11[or is a 9
[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.]
12[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 by any department of Government as they apply in relation to
the manufacture, sale or distribution of drugs by any other person.]
1. Ins. by Act 21 of 1962, s. 20 (w.e.f. 27-7-1964).
2. Subs. by Act 68 of 1982, s. 25, for “one thousand rupees” (w.e.f. 1-2-1983).
3. The words and figures “section 28 or” omitted by Act 13 of 1964, s. 20 (w.e.f. 15-9-1964).
4. Subs. by Act 26 of 2008, s. 11, for “ten years or with fine or with both” (w.e.f. 10-8-2009)
5. Re-numbered as sub-section (I) by Act 35 of 1960, s. 9 (w.e.f. 16-3-1961).
6. Ins. by Act 21 of 1962, s. 21 (w.e.f. 27-7-1964).
7. Added by Act 13 of 1964. s. 21 (w.e.f. 15-9-1964).
8. Subs. by Act 68 of 1982, s. 26, for cl. (i) (w.e.f. 1-2-1983).
9. Subs. by s. 26, ibid„ for certain words (w.e.f. 1-2-1983).
10. Sub-section (2) ins. by Act 35 of 1960, s. 9, subs. by Act 21 of 1962, s. 21 (w. e.f. 27-7-1964).
11. Subs. by Act 13 of 1964. s. 21, for “or is a misbranded drug” (w.e.f. 15-9-1964).
12. Ins. by s. 22. ibid. (w.e.f. 15-9-1964).
26
32. Cognizance of offences—1
[(1) No prosecution under this Chapter shall be instituted except
by—
(a) an Inspector; or
(b) any gazetted officer of the Central Government or a State Government authorised in writing in
this behalf by the Central Government or a State Government or by a general or special order made in
this behalf by that Government; or
(c) the person aggrieved; or
(d) a recognised consumer association whether such person is a member of that association or
not.
(2) Save as otherwise provided in this Act, no court inferior to that of a Court of Session 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.
2
[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 3
[in sub-sections (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.]
4
[32B. Compounding of certain offences. — (1) Notwithstanding anything contained in the Code of
of Criminal Procedure, 1973, (2 of 1974) any offence punishable under clause (b) of sub-section (1) of
section 13, section 28 and section 28A of this Act (whether committed by a company or any officer
thereof), not being an offence punishable with imprisonment only, or with imprisonment and also with fine,
may, either before or after the institution of any prosecution, be compounded by the Central Government or by
any State Government or any officer authorised in this behalf by the Central Government or a State
Government, on payment for credit to that Government of such sum as that Government may, by rules made
in this behalf, specify:
Provided that such sum shall not, in any case, exceed the maximum amount of the fine which may be
imposed under this Act for the offence so compounded:
Provided further that in cases of subsequent offences, the same shall not be compoundable.
(2) When the accused has been committed for trial or when he has been convicted and an appeal is
pending, no composition for the offence shall be allowed without, the leave of the court to which he is
committed or, as the case may be, before which the appeal is to be heard.
(3) Where an offence is compounded under sub-section (1), no proceeding or further proceeding, as
the case may be, shall be taken against the offender in respect of the offence so compounded and the
offender, if in custody, shall be released forthwith.]
1. Subs. by Act 26 of 2008, s. 12, for sub-sections (1) and (2) (w.e.f. 10-8-2009).
2. Ins. by Act 13 of 1964, s. 23 (w.e.f. 15-9-1964).
3. Subs. by Act 68 of 1982, s. 28, for “in sub-section (1) of section 351 of the Code of Criminal Procedure, 1898” (w.e.f. 1-2-1983).
4. Ins. by Act 26 of 2008, s. 13 (w.e.f. 10-8-2009).
27
33. Power of Central Government to make rules. — 1
[(1) The Central Government may
2
[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 analysing drugs 3
[or
cosmetics];
(b) prescribe 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 3
[or
cosmetic] is of standard quality;
(d) prescribe, in respect of biological and organometallic compounds, the units or methods of
standardisation;
4
[(dd) prescribe under clause (d) of 5
[section 17A] the colour or colours which a drug may bear
or contain for purposes of colouring;]
6
[(dda) prescribe under clause (d) of section 17E the colour or colours which a cosmetic may
bear or contain for the purposes of colouring];
(e) prescribe the forms of licences 7
[for the manufacture for sale or for distribution], for the sale
and for the distribution of drugs or any specified drug or class of drugs 8
[or of cosmetics 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 9
[the
qualifications of such authority] and the fees payable therefor 9
[and provide 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];
9
[(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 licences) 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 10[to prevent
cure or mitigate] and such other effects which a drug may not purport or claim to have;
1. Subs. by Act 11 of 1955, s. 15, for sub-section (1).
2. Subs. by Act 68 of 1982, s. 29, for “after consultation with the Board” (w.e.f. 1-2-1983).
3. Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964).
4. Ins. by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964).
5. Subs. by Act 68 of 1982, s. 29, for “section 17B” (w.e.f. 1-2-1983).
6. Ins. by Act 26 of 2008, s. 14 (w.e.f. 10-8-2009).
7. Subs. by Act 68 of 1982, s. 29, for “for the manufacture for sale” (w.e.f. 1-2-1983).
8. Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964).
9. Ins. by Act 68 of 1982, s. 29 (w.e.f. 1-2-1983).
10. Subs. by Act 11 of 1955, s. 15, for “to cure or mitigate”
28
(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 and
truly stated on the lable 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 1
[or cosmetics], 2
[including the use of packing material which comes into direct contact with
with the drugs] and prohibit the sale, stocking or exhibition for sale, or distribution of drugs
1
[or cosmetics], packed in contravention of such conditions;
(j) regulate the mode of labelling packed drugs 1
[or cosmetics], and prescribe the
matters which shall or shall not be included in such labels;
(k) prescribe the maximum proportion of any poisonous substance which may be added to 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 lable or wrapper of any patent or proprietary medicine containing such drug;
3
* * * * *
4
[(n) prescribe the powers and duties of Inspectors 2
[and the qualifications of the authority to
which such Inspectors shall be subordinate] and 5
[specify the drugs or classes of drugs of 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;
6
[(p) specify the offences against this Chapter or any rule made thereunder in relation to which an
an order of confiscation may be made under section 31;
7
***]
(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
1
[or cosmetic or class of
cosmetics]
8
[and];
1. Ins. by Act 21 of 1962, s. 22 (w.e.f. 27-7-1964).
2. Ins. by Act 68 of 1982, s. 29 (w.e.f. 1-2-1983).
3. Cl. (m) omitted by Act 13 of 1964, s. 24 (w.e.f. 15-9-1964).
4. Subs. by Act 35 of 1960, s. 10, for cl. (n) (w.e.f. 16-3-1961).
5. Subs. by Act 21 of 1962, s. 22, for “the drugs or class of drugs” (w.e.f. 27-7-1964).
6. Subs. by Act 13 of 1964, s. 24, for cl. (p) (w.e.f. 15-9-1964).
7. The word “and” omitted by Act 26 of 2008, s. 14 (w.e.f. 10-8-2009).
8. Ins. by, s. 14 ibid. (w.e.f. 10-8-2009).
29
1
[(r) sum which may be specified by the Central Government under section 32B.]
2
* * * * *
3
[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 4
[Ayurvedic, Siddha
Siddha or Unani] drugs.]