Drugs and Cosmetics Act, 1940- Sections 27 to 33-A

27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter.

[i][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 17-A or spurious under Section [ii][17-B 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 [iii][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:]

[iv][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 17-A, 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 [v][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 [vi][less than three years and of fine of less than one lakh rupees];

(c) any drug deemed to be spurious under Section 17-B, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall [vii][not less than seven years but which may extend to imprisonment for life and with fine which shall not be (sic less than) 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 [viii][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 [ix][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.]

Other Contents of Drugs and Cosmetics Act, 1940
Sections 1 to 7-A
Sections 8 to 15
Sections 16 to 20
Sections 21 to 26-B
Sections 27 to 33-A
Sections 33-B to 33-O
Sections 33-P to 38
Schedules

27-A. Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter.

[x][27-A. 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—

[xi][(i) any cosmetic deemed to be spurious under Section 17-D or adulterated under Section 17-E 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.]]

28. Penalty for non-disclosure of the name of the manufacturer, etc.

[xii][28. Penalty for non-disclosure of the name of the manufacturer, etc.—Whoever contravenes the provisions of Section 18-A [xiii][or Section 24] shall be punishable with imprisonment for a term which may extend to one year, or [xiv][with fine which shall not be less than twenty thousand rupees or with both].

28-A. Penalty for not keeping documents, etc., and for non-disclosure of information.

[xv][28-A. Penalty for not keeping documents, etc., and for non-disclosure of information.—Whoever without reasonable cause or excuse contravenes the provisions of Section 18-B shall be punishable with imprisonment for a term which may extend to one year or [xvi][with fine which shall not be less than twenty thousand rupees or with both].

28-B. Penalty for manufacture, etc., of drugs or cosmetics in contravention of Section 26-A.

28-B. Penalty for manufacture, etc., of drugs or cosmetics in contravention of Section 26-A.—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 26-A, 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.

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

30. Penalty for subsequent offences.

[xix][30. Penalty for subsequent offences.—[xx][(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 [xxi][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 [xxii][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 [xxiii][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 [xxiv][fifty thousand rupees], or with both.]

[xxv][(1-A) Whoever, having been convicted of an offence under Section 27-A 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 [xxvi][two thousand rupees], or with both.]

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

31. Confiscation.

31. Confiscation.—[xxix][(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 [xxx][or cosmetic] in respect of which the contravention has been made shall be liable to confiscation [xxxi][and if such contravention is in respect of —

[xxxii][(i) manufacture of any drug deemed to be misbranded under Section 17, adulterated under Section 17-A or spurious under Section 17-B; or]

(ii) [xxxiii][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.]

[xxxiv][(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 [xxxv][or is a [xxxvi][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.]

31-A. Application of provisions to Government departments.

[xxxvii][31-A. 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.]

32. Cognizance of offences.

32. Cognizance of offences.—[xxxviii][(1) No prosecution under this Chapter shall be instituted except by—

(a) and 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.

32-A. Power of Court to implead the manufacturer, etc.

[xxxix][32-A. 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 [xl][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.]

32-B. Compounding of certain offences.

[xli][32-B. Compounding of certain offences.—(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 28-A 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 instruction 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.]

33. Powers of Central Government to make rules.

33. Powers of Central Government to make rules.—[xlii][(1) The Central Government may after consultation with [xliii][, 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 rule may—

(a) provide for the establishment of laboratories for testing and analysing drugs [xliv][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 [xlv][or cosmetic] is of standard quality;

(d) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation;

[xlvi][(dd) prescribe under clause (d) of Section [xlvii][17-A] the colour or colours which a drug may bear or contain for purposes of colouring;]

[xlviii][(dda) prescribe under clause (d) of Section 17-E the colour or colours which a cosmetic may bear or contain for the purposes of colouring;]

(e) prescribe the forms of licences for the manufacture for sale [xlix][or for distribution], for the sale and for the distribution of drugs or any specified drug or class of drugs [l][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 [li][the qualifications of such authority] and the fees payable therefore [lii][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;]

[liii][(ee) prescribe the records, registers or other documents to be kept and maintained under Section 18-B;

(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 (2-A) of Section 22;]

(f) specify the diseases or ailments which a drug may not purport or claim [liv][to prevent, cure or mitigate] and such other effects which a drug may not purport or claim to have;

(g) prescribe the conditions subject to which small quantities of drugs may be manufactured for the purpose of examination, test or analysis;

(h) require the date of manufacture and the date of expiry of potency to be clearly and truly stated on the label or container of any specified drug or class of drugs, and prohibit the sale, stocking or exhibition for sale, or distribution of the said drug or class of drugs after the expiry of a specified period from the date of manufacture or after the expiry of the date of potency;

(i) prescribe the conditions to be observed in the packing in bottles, packages, and other containers of drugs [lv][or cosmetics] [lvi][including the use of packing material which comes into direct contact with the drugs], and prohibit the sale, stocking or exhibition for sale, or distribution of drugs [lvii][or cosmetics] packed in contravention of such conditions;

(j) regulate the mode of labelling packed drugs [lviii][or cosmetics], and prescribe the matter which shall or shall not be included in such labels;

(k) prescribe the maximum proportion of any poisonous substance which may be added 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 label or wrapper of any patent or proprietary medicine containing such drug;

(m) [lix][* * *]

[lx][(n) prescribe the powers and duties of Inspectors [lxi][and the qualifications of the authority to which such Inspectors shall be subordinate] and [lxii][specify the drugs or classes of drugs or cosmetics or classes of cosmetics] in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed;]

(o) prescribe the forms of report to be given by Government Analysts, and the manner of application for test or analysis under Section 56 and the fees payable therefor;

[lxiii][(p) specify the offences against this Chapter or any rule made thereunder in relation to which an order of confiscation may be made under Section 31; [lxiv][* * *]

(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 [lxv][or cosmetic or class of cosmetics; [lxvi][and]

[lxvii][(r) sum which may be specified by the Central Government under Section 32-B;]

[lxviii][* * *]

33-A. Chapter not to apply to Ayurvedic, Siddha or Unani drugs.

[lxix][33-A. Chapter not to apply to [lxx][Ayurvedic, Siddha or Unani] drugs.—Save as otherwise provided in this Act, nothing contained in this Chapter shall apply to [lxxi][Ayurvedic, Siddha or Unani] drugs.]

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