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THE DRUGS AND COSMETICS ACT, 1940

Title : THE DRUGS AND COSMETICS ACT, 1940

Year : 1940



1*[(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 in2*[the Second Schedule], and

(b) In relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.]

(2) The3*[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 amend2*[the Second Schedule] for the purposes of this Chapter, and thereupon2*[the Second Schedule] shall be deemed to be amended accordingly.

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1. Substituted by Act 21 of 1962, Section 12, for sub-section (1) (w.e.f. 27-7-1964).

2. Substituted by Act 13 of 1964, Section 11, for "the Schedule" (w.e.f. 15-9-1964).

3. Substituted by Act 11 of 1955, Section 8, for "State Government" (w.e.f. 15-4-1955).

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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.

17A -2* 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 in sanitary 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 -3* 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 -4* 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 - 4*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 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.]

17E -5* Adulteated 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 in sanitary 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.]

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1. Substituted by Act 68 of 1982, Section 13, for sections 17 (w.e.f. 1-2-1983).

2. Section 17A ns. by Act 21 of 1962, Section 13 (w.e.f. 27-7-1963) and Substituted by Act 68 of 1982, Section 13 (w.e.f. 1-2-1983).

3. Section 17B Inserted by Act 13 of 1964, Section 12 (w.e.f. 15-9-1964) and Substituted by Act 68 of 1982, Section 13 (w.e.f. 1-2-1983)

4. Inserted by Act 68 of 1982, Section 13 (w.e.f. 1-2-1983).

5. Inserted by the drug and cosmetics (amendment) act 2008.

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From such date1as 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)2*[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute-

3*(i) Any drug which is not of a standard quality, or is misbranded, adulterated or spurious;

13*[(ii) Any cosmetic which is not of a standard quality, or is misbranded, adulterated or spurious;]

4*[(iii) Any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof5*[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 claims6*[to prevent, cure or mitigate] any such disease or ailment, or to have any such other effect as may be prescribed;

7*[(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)5*[sell, or stock or exhibit or offer for sale,] or distribute any drug 8*[or cosmetic] which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made there under;

(c)9*[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute any drug8*[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 the10*[Central Government] may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the11*[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.

12[***]

18A -14* 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 -15* 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.

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1. 1st April, 1947, for sub-clauses (i), (ii), (iv) and (v) of clause (a) and clauses (b) and (c); 1st April, 1949 for sub-clause (iii) of clause (a) in so far as it takes effect in Delhi, Ajmer and Coorg, see Notification No. 18-12-46-D, II, dated 11th February, 1947, Gazette of India, 1947, Pt. 1, p. 189, as amended by Notification No. F.l-2/48-D(II), dated 29th September, 1948; 1st April, 1953 for the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur, vide Notification No. S.R.O. 664, dated 30th March, 1953, Gazette of India, 1953, Pt. II, Section 3, p. 451.

2. Substituted by Act 68 of 1982, Section 14, for "manufacture for sale, or sell, or stock or exhibit for sale" (w.e.f. 1-2-1983).

3. Substituted by Act 68 of 1982, Section 14, for clause (i), (ii) and (iia) (w.e.f. 1-2-1983) earlier clause (iia) was Inserted by Act 13 of 1964, Section 13 (w.e.f. 15-9-1964).

4. Substituted by Act 11 of 1955, Section 9, for sub-clause (iii).

5. Substituted by Act 68 of 1982, Section 14, for certain words (w.e.f. 1-2-1983).

6. Substituted by Act 11 of 1955, Section 9, for "to cure or mitigate".

7. Substituted by Act 21 of 1962, Section 14, for sub-clause (v) (w.e.f. 27-7-1964).

8. Inserted by Act 21 of 1962, Section 14 (w.e.f. 27-7-1964).

9. Substituted by Act 68 of 1982, Section 14, for certain words (w.e.f. 1-2-1983).

10. Substituted by Act 11 of 1955, Section 9, for "State Government".

11. Substituted by Act 68 of 1982, Section 14, for "manufacture for sale, sale" (w.e.f. 1-2-1983).

12. Explanation omitted by Act 68 of 1982, Section 14 (w.e.f. 1-2-1983).

13. Substituted by the drugs and cosmetics (amendment) act 2008 for the following :-

"(ii) any cosmetic which is not of a standard quality or is misbranded or spurious;]"

14. Inserted by Act 13 of 1964, Section 14 (w.e.f. 15-9-1964).

15. Inserted by Act 68 of 1982, Section Section 15 (w.e.f 1-2-1983).

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(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 1*[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)2*[For the purposes of section 18 a drug shall not be deemed to be misbranded or 3*[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 drug1*[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 drug1[or cosmetic] or to conceal its inferior quality or other defects; or

4[***]

(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 drug1*[or cosmetic] occurring after the vendor or distributor became aware of such intermixture.

5*[(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]

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1. Inserted by Act 21 of 1962, Section 15 (w.e.f. 27-7-1964).

2. Substituted by Act 13 of 1964, Section 15, for certain words (w.e.f. 15-9-1964).

3. Substituted by Act 68 of 1982, Section 16, for "adulterated" (w.e.f. 1-2-1983).

4. 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).

5. Substituted by Act 13 of 1964, Section 15, for sub-section (3) (w.e.f. 15-9-1964).

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(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 or2*[classes of drugs or such cosmetics or classes of cosmetics] as may be specified in the notifications.

(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 or2*[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.]

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.]

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1. Substituted by Act 35 of 1960, Section 4, for section 20 (w.e.f. 16-3-1961).

2. Substituted by Act 21 of 1962, Section 16, for "class of drugs" (w.e.f. 27-7-1964).

3. Inserted by Act 68 of 1982, Section 17 (w.e.f. 1-2-1983).

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(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 2*[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 interest3*[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 authority4*[, having the prescribed qualifications,] as the Government appointing him may specify in this behalf.]

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1. Substituted by Act 35 of 1960, Section 4, for section 21 (w.e.f. 16-3-1961).

2. Substituted by Act 21 of 1962, Section 17 for "class of drugs" (w.e.f. 27-7-1964).

3. Substituted by Act 21 of 1962, Section 17, for "in the manufacture, import or sale of drugs" (w.e.f. 27-7-1964).

4. Inserted by Act 68 of 1982, Section 18 (w.e.f. 1-2-1983).

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(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,-

2*[(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;

(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 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;]

3*[(cc) Examine any record, register, document or any other material object found4*[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;]

5*[(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 of6[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 under7*[section 94] of the said Code.

5*[(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 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 5*[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.]

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1. Substituted by Act 11 of 1955, Section 11, for section 22 (w.e.f. 15-4-1955).

2. Substituted by Act 68 of 1982, Section 19, for clauses (a), (b) and (c) (w.e.f. 1-2-1983).

3. Inserted by Act 35 of 1960, Section 5 (W.e.f. 16-3-1961).

4. Substituted by Act 68 of 1982, Section 19, for "in any place mentioned in clause (c)" (w.e.f. 1-2-1983).

5. Inserted by Act 68 of 1982, Section 19 (w.e.f. 1-2-1983).

6. Substituted by Act 68 of 1982, Section 19, for "the Code of Criminal Procedure, 1898 (5 of 1898)" (w.e.f. 1-2-1983).

7. Substituted by Act 68 of 1982, Section 19, for "section 98" (w.e.f. 1-2-1983).

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(1) Where an Inspector takes any sample of a drug1*[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 drug1[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 drug1*[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 drug1*[or cosmetic] is being manufactured, it shall be necessary to divide the sample into three portions only:

Provided further that where the drug1[or cosmetic] is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug1*[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 drug1[or cosmetic]; and

2*[(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 drug1*[or cosmetic] contravenes any of the provisions of section 18 and, if it is ascertained that the drug1*[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 drug1*[or cosmetic], he shall as soon as may be, inform 3*[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 drug1*[or cosmetic], he shall, on being satisfied that the defect has been so remedied, forthwith revoke his order under the said clause.

4*[(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, inform3*[a Judicial Magistrate] and take his orders as to the custody thereof.]

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1. Inserted by Act 21 of 1962, Section 15 (w.e.f. 27-7-1964).

2. Substituted by Act 13 of 1964, Section 16, for clause (iii) (w.e.f. 15-9-1964).

3. Substituted by Act 68 of 1982. Section 20, for "a Magistrate" (w.e.f. 1-2-1983).

4. Inserted by Act 35 of 1960, Section 6 (w.e.f. 16-3-1961).

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Every person for the time being in charge of any premises whereon any drug1*[or cosmetic] is being manufactured or is kept for sale or distribution shall, on being required by any Inspector so to do, be legally bound to disclose to the Inspector the place where the drug1*[or cosmetic] is being manufactured or is kept, as the case may be.

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1. Inserted by Act 21 of 1962, Section 15 (w.e.f. 27-7-1964).

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(1) The Government Analyst to whom a sample of any drug1*[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 taken2*[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 taken3*[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 drug1*[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.

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1. Inserted by Act 21 of 1962, Section 15 (w.e.f. 27-7-1964).

2. Substituted by Act 13 of 1964, Section 17, for certain words (w.e.f. 15-9-1964).

3. Substituted by Act 13 of 1964, Section 17, for "or the said warrantor" (w.e.f. 15-9-1964).

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Any person1*[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 drug2*[or cosmetic]3*[purchased by him or it] and to receive a report of such test or analysis signed by the Government Analyst.

4*[Explanation.-For the purposes of this section and section 32, "recognised consumer association" means a voluntary consumer association registered under the Companies Act, 1956 or any other law for the time being in force.]

26A -5* Powers 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, 6*[regulate, restrict or prohibit] the manufacture, sale or distribution of such drug or cosmetic]

26B - Power of Central Government to regulate or restrict, manufacture, etc., of drug in public interest

7*[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.]

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1. Inserted by Act 71 of 1986, Section 2 (w.e.f. 15-9-1987).

2. Inserted by Act 21 of 1962, Section 15 (w.e.f. 27-7-1964).

3. Substituted by Act 71 of 1986, Section 2, for "purchased by him"' (w.e.f. 15-9-1987).

4. Added by Act 71 of 1986, Section 2 (w.e.f. 15-9-1987).

5. Inserted by Act 68 of 1982. Section 21 (w.e.f. 1-2-1983).

6. Substituted by the drug and cosmetics (amendment) act 2008 dated 05.12.2008 for the word "prohibit".

7. Inserted by the drug and cosmetics (amendment) act 2008.

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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 2*[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 3*[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:]

4*[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 5*[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 6*[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 7 [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 8 [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 9 [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 - 10* 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-

11*[(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 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.]

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1. 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).

2. Substituted by the drug and cosmetics (amendment) act 2008 dated 05.12.2008 for the figures, letter and words "17B or which".

3. 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;".

4. Inserted by the drug and cosmetics (amendment) act 2008 dated 05.12.2008.

5. 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".

6. 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".

7. 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".

8. 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".

9. Substituted by the drug and cosmetics (amendment) act 2008 dated 05.12.2008 for the words "and with fine".

10. 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).

11. 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.

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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 4[with fine which shall not be less than twenty thousand rupees or with both.]

28A -5* 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 6*[with fine which shall not be less than twenty thousand rupees or with both.]

28B -7* 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.

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1. Substituted by Act 13 of 1964, Section 19, for section 28 (w.e.f. 15-9-1964).

2. Inserted by Act 68 of 1982, Section 23 (w.e.f. 1-2-1983).

3. Substituted by Act 68 of 1982, Section 23, for "five hundred rupees" (w.e.f. 1-2-1983).

4. Substituted by the drug and cosmetics (amendment) act 2008 for the words "with fine which may extend to 3[one thousand rupees], or with both.]".

5. Inserted by Act 68 of 1982, Section 24 (w.e.f. 1-2-1983).

6. Substituted by the drug and cosmetics (amendment) act 2008 for the words "with fine which may extend to one thousand rupees or with both".

7. Inserted by Act 68 of 1982, Section 24 (w.e.f. 1-2-1983).

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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 1[or cosmetic], shall be punishable with fine which may extend to 2[five thousand rupees].

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1. Inserted by Act 21 of 1962, Section 15 (w.e.f. 27-7-1964).

2. Substituted by the drug and cosmetics (amendment) act 2008 for the words "five hundred rupees".

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2*[(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 7[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 8[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 9*[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 10[fifty thousand rupees], or with both.]

3*[(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 4*[two thousand rupees], or with both.]

(2) Whoever, having been convicted of an offence under 5[* * *] section 29 is again convicted of an offence under the same section, shall be punishable with imprisonment which may extend to 11[two years, or with fine which shall not be less than ten thousand rupees or with both.]

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1. Substituted by Act 11 of 1955, Section 14, for section 30 (w.e.f. 15-4-1955).

2. 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).

4. Substituted by Act 68 of 1982, Section 25, for "one thousand rupees" (w.e.f. 1-2-1983).

5. 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).

7. 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".

8. 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".

9. 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".

10. Substituted by the drug and cosmetics (amendment) act 2008 for the words "five thousand rupees".

11. Substituted by the drug and cosmetics (amendment) act 2008 for the words "6[ten years], or with fine, or with both.]".
 
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1*[(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 drug2*[or cosmetic] in respect of which the contravention has been made shall be liable to confiscation3*[and if such contravention is in respect of-

4*[(i) manufacture of any drug deemed to be misbranded under section 17, adulterated under section 17A or spurious under section 17B; or],

(ii)5*[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].

6*[(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 quality7*[or is a8*[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 -9* 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.]

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1. Section 31 re-numbered as sub-section (1) of that section by Act 35 of 1960, Section 9 (w.e.f. 16-3-1961).

2. Inserted by Act 21 of 1962, Section 21 (w.e.f. 27-7-1964).

3. Added by Act 13 of 1964, Section 21 (w.e.f. 15-9-1964).

4. Substituted by Act 68 of 1982, Section 26, for clause (i) (w.e.f. 1-2-1983).

5. Substituted by Act 68 of 1982, Section 26, for certain words (w.e.f. 1-2-1983).

6. Sub-section (2) Inserted by Act 35 of 1960, Section 9(w.e.f. 16-3-1961) and Substituted by Act 21 of 1962, Section 21 (w.e.f. 27-7-1964).

7. Substituted by Act 13 of 1964, Section 21, for "or is a misbranded drug" (w.e.f. 15-9-1964).

8. Substituted by Act 68 of 1982, Section 26, for "misbranded or adulterated drug, or misbranded cosmetic" (w.e.f. 1-2-1983).

9. 1ns. by Act 13 of 1964, Section 22 (w.e.f. 15-9-1964).

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3*[(1) No prosecution under this Chapter shall be instituted except by-

(a) An Inspector; or

(b) Any gazetted officer of the Central Government or a State Government authorised in writing in this behalf by the Central Government or a State Government by a general or special order made in this behalf by that Government; or

(c) The person aggrieved; or

(d) A recognised consumer association whether such person is a member of that association or not.

(2) 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.

32A -4* 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 5*[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.]

32B - Compound of certain offences

6*[(1) Notwithstanding anything contained in the Code 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.

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1. Inserted by Act 71 of 1986, Section 3 (w.e.f. 15-9-1987).

2. Substituted by Act 68 of 1982, Section 27, for "a Presidency Magistrate or of a Magistrate of the first class" (w.e.f. 1-2-1983).

3. Substituted by the Drugs and Cosmetics (Amendment) Act, 2008 for the following :-

"(1) No prosecution under this Chapter shall be instituted except by an Inspector1[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 of2[a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under this Chapter.

4. Inserted by Act 13 of 1964, Section 23 (w.e.f. 15-9-1964).

5. Substituted by Act 68 of 1982, Section 28, for "in sub-section (1) of section 351 of the Code of Criminal Procedure, 1898 (5 of 1898)" (w.e.f. 1-2-1983).

6. Inserted by the drug and cosmetics (amendment) act 2008 dated 05.12.2008.

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Last updated on July, 2016

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