Drugs and Cosmetics Act, 1940 :: Indian Bare Acts



1. Short title, extent and commencement

(1) This Act may be called the Drugs 4[and Cosmetics] Act, 1940.

(2) It extends to the whole of India 5[***]

(3) It shall come in to force at once; but Chapter III shall take effect only from such 6date as the Central Government may, by notification in the Official Gazette, appoint in this behalf, and Chapter IV shall take effect in a particular State only from such 6date as the State Government may, by like notification, appoint in this behalf.

7[Provided that in relation to the State of Jammu and Kashmir, Chapter III shall take effect only from such 8date after the commencement of the Drugs and Cosmetics (Amendment) Act, 1972, as the Central Government may, by notification in the Official Gazette, appoint in this behalf.]



2. Application of other laws not barred

The provisions of this Act shall be in addition to, and not in derogation of, the Dangerous Drugs Act, 1930, and any other law for the time being in force.



3. Definitions

In this Act, unless there is anything repugnant in the subject or context,-

9[(a) "10[Ayurvedic, Siddha or Unani] drug" includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of 11[disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulae described in, the authoritative books of 11[Ayurvedic, Siddha and Unani Tibb system of medicine], specified in the First Schedule,]

12[(aa) "the Board" means-

(i) in relation to 10[Ayurvedic, Siddha or Unani] drug, the 11[Ayurvedic, Siddha and Unani Drugs Technical Advisory Board] constituted under section 33C; and

(ii) in relation to any other drug or cosmetic, the Drugs Technical Advisory Board constituted under section 5;]

13[14[(aaa)] "cosmetic" means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic 15[***];]

16[(b) "drug" includes-

17[(i) all. medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes ;]

(ii) such substances (other than food) intend to affect the structure or any function of the human body or intended to be used for the destruction of 18'[vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;]

19[(iii) all substances intended for use as components of a drug including empty gelatine capsules; and

(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;]

20[(c) "Government Analyst" means-

(i) in relation to 10[Ayurvedic, Siddha or Unani] drug, a Government Analyst appointed by the Central Government or a State Government under section 33F; and

(ii) in relation to any other drug or cosmetic, a Government Analyst appointed by the Central Government or a State Government under section 20;]

21[***]

22[(e) "Inspector" means-

(i) in relation to 10[Ayurvedic, Siddha or Unani] drug, an Inspector appointed by the Central Government or a State Government under section 33G; and

(ii) in relation to any other drug or cosmetic, an Inspector appointed by the Central Government or a State Government under section 21;]

23[24 (f) manufacture" in relation to any drug 13[or cosmetic] includes any process or part of a process for making, altering, ornamenting, finishing, packing, labeling, breaking up or otherwise treating or adopting any drug 13[or cosmetic] with a view to its 25[sale or distribution] but does not include the compounding or dispensing 26[of any drug, or the packing of any drug or cosmetic,] in the ordinary course of retail business; and "to manufacture" shall be construed accordingly;]

27[(g)] "to import", with its grammatical variations and cognate expressions means to bring into 28[India];

29[(h) "patent or proprietary medicine" means,-

(i) in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha of Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a);

(ii) in relation to any other systems of medicine, a drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorized in the behalf by the Central Government after consultation with the Drugs Technical Advisory Board constituted under section 5;]

30[27[(i)] "prescribed" means prescribed by rules made under this Act.]



3A. Construction of references to any law not in force or any functionary not in existence in the State of Jammu and Kashmir

Any reference in this Act to any law which is not in force, or any functionary not in existence, in the State of Jammu and Kashmir, shall, in relation to that State, be construed as a reference to the corresponding law in force, or to the corresponding  functionary in existence, in that State.]



4. Presumption as to poisonous substances

Any substance specified as poisonous by rule made under Chapter II or Chapter IV 33[or Chapter IVA] shall be deemed to be a poisonous substance for the purposes of Chapter III or Chapter IV 33[or Chapter IVA], as the case may be.



5.The Drugs Technical Advisory Board

(1) The Central Government shall, as soon as may be, constitute a Board (to be called the Drugs Technical Advisory Board) to advise the Central Government and the State Governments on technical matters arising out the administration of this Act and to carry out the other functions assigned to it by this Act.

34[(2) The Board shall consist of the following members, namely :-

(i) the Director General of Health Services, ex officio, who shall be Chairman;

(ii) the Drugs Controller, India, ex officio;

(iii) the Director of the Central Drugs Laboratory, Calcutta, ex officio;

(iv) the Director of the Central Research Institute, Kasauli, ex office;

(v) the Director of the Indian Veterinary Research Institute, Izatnagar, ex officio;

(vi) the President of the Medical Council of India, ex officio;

(vii) the President of the Pharmacy Council of India, ex officio;

(viii) the Director of the Central Drug Research Institute, Lucknow, ex officio;

(ix) two persons to be nominated by the Central Government from among persons who are in charge of drugs control in the States;

(x) one person, to be elected by the Executive Committee of the Pharmacy Council of India, from among teachers in pharmacy or pharmaceutical chemistry or pharmacognosy on the staff of an Indian university or a college affiliated thereto;

(xi) one person, to be elected by the Executive Committee of the Medical Council of India, from among teachers in medicine or therapeutics on the staff of an Indian university or a college affiliated thereto;

(xii) one person to be nominated by the Central Government from the pharmaceutical industry;

(xiii) one pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research;

(xiv) one person to be elected by the Central Council of the Indian Medical Association;

(xv) one person to be elected by the Council of the Indian Pharmaceutical Association;

(xvi) two persons holding the appointment of Government Analyst under this Act, to be nominated by the Central Government.]

(3) The nominated and elected members of the Board shall hold office for three years, but shall be eligible for re-nomination and re-election:

35[Provided that the person nominated or elected, as the case may be, under clause (ix) or clause (x) or clause (xi) or clause (xvi) of sub-section (2) shall hold office for so long as he holds the appointment of the office by virtue of which he was nominated or elected to the Board.]

(4) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and regulating its own procedure and the conduct of all business to be transacted by it.

(5) The Board may constitute sub-committees and may appoint to such sub-committees for such periods, not exceeding three years. as it may decide, or temporarily for the consideration of particular matters, persons who are not members of the Board.

(6) The functions of the Board may be exercised notwithstanding any vacancy therein.

(7) The Central Government shall appoint a person to be Secretary of the Board and shall provide the Board with such clerical and other staff as the Central Government considers necessary.



6. The Central Drugs Laboratory

(1) The Central Government shall, as soon as may be, establish a Central Drugs Laboratory under the control of a Director to be appointed by the Central Government, to carry out the functions. entrusted to it by this Act or any rules made under this Chapter:

Provided that, if the Central Government so prescribes, the functions of the Central Drugs Laboratory in respect of any drug or class of drugs 29[or cosmetic or class of cosmetics] shall be carried out at the Central Research Institute, Kasauli, or at any other prescribed Laboratory and the functions of the Director of the Central Drugs Laboratory in respect of such drug or class of drugs 29[or such cosmetic or class of cosmetics] shall be exercised by the Director of that Institute or of that other Laboratory, as the case may be.

(2) The Central Government may, after consultation with the Board, make rules prescribing

(a) the functions of the Central Drugs Laboratory;

36[***]

(d) the procedure for the submission to the said Laboratory 37[under Chapter IV or Chapter IVA] of samples of drugs 29[or cosmetics] for analysis or test, the forms of the Laboratory's reports thereon and the fees payable in respect of such reports;

(e) such other matters as may be necessary or expedient to enable the said Laboratory to carry out its functions;

(f) the matters necessary to be prescribed for the purposes of the proviso to sub-section (1).



7. The Drugs Consultative Committee

(1) The Central Government may constitute an advisory committee to Committee be called "the Drugs Consultative Committee" to advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any matter tending to secure uniformity throughout 28[India] in the administration of this Act.

(2) The Drugs Consultative Committee shall consist of two representatives of the Central Government to be nominated by that Government and one representative of each State Government to be nominated by the State Government concerned.

(3) The Drugs Consultative Committee shall meet when required to do so by the Central Government and shall have power to regulate its own procedure.



7A. Section 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs

Nothing contained in sections 5 and 7 shall apply to 10[Ayurvedic, Siddha or Unani drugs.]



8. Standards of quality

40[(1) For the purposes of this Chapter, the expression "standard quality" means-

(a) in relation to a drug, that the drug complies with the standards set out in 41[the Second Schedule], and

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

(2) The Central Government, after consultation with the Board and after giving by notification in the Official Gazette not less than three months' notice of its intention so to do, may by a like notification add to or otherwise amend 41[the Second Schedule], for the purposes of this Chapter, and thereupon 41[the Second Schedule] shall be deemed to be amended accordingly.



9. Misbranded drugs

For the purposes of this Chapter, a drug shall be deemed to be misbranded-

(a) if it is so colored, 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 labeled in the prescribed manner; or

(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.]



9A. Adulterated drugs

For the purposes of this Chapter, a drug shall be deemed to be adulterated,

(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with fifth or whereby it may have been rendered injurious to health; or

(c) if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of coloring only, a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.



9B. Spurious drugs

For the purposes of this Chapter, a drug shall be deemed to be spurious-

(a) if it is imported under a name which belongs to another drug; or

(b) if it is an imitation of, or 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.



9C. Misbranded cosmetics

For the purposes of this Chapter, a cosmetic shall be deemed to be misbranded-

(a) if it contains a colour which is not prescribed; or

(b) if it is not labeled 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.



9D. Spurious cosmetics

For the purposes of this Chapter, a cosmetic shall be deemed to be spurious,-

(a) if it is imported under a name which belongs to another cosmetic; or

(b) if it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic, unless it is plainly 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 is an imitation of, or is a substitute for, another drug or re-not truly a product.]



10. Prohibition of import of certain drugs or cosmetics

From such date44 as may be fixed by the Central Government by notification in the Official Gazette in this behalf, no person shall import-

(a) any drug 45[or cosmetic] which is not of standard quality;

46[(b) any misbranded drug 47[or misbranded or spurious cosmetics];]

48[(bb) any 49[adulterated or spurious] drug;]

(c) any drug 45[or cosmetic] for the import of which a license is prescribed, otherwise than under, and in accordance with, such license;

50[(d) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof 51[the true formula or list of active ingredients contained in it together with the quantities thereof];]

(e) any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other effect, as may be prescribed;

45[(ee) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;

(j) any drug 45[or cosmetic] the import of which is prohibited by rule made under this Chapter :

Provided that nothing in this section shall apply to the import, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis or for personal use :

Provided further that the Central Government may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the import of any drug or class of drugs not being of standard quality.



10A. Power of Central Government to prohibit import of drugs and cosmetics in public interest

Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied that the, use of any drug or cosmetic is to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the import of such drug or cosmetic.]



11 Application of law relating to sea customs and powers of Customs offices

(1) The law for the time being in force relating to sea customs and to goods, the import of which is prohibited by section 18 of the Sea Customs Act, 187854 shall, subject to the provisions of section 13 of this Act, apply in respect and of drugs 55[and cosmetics] the import of which is prohibited under this Chapter, and officers of Customs and officers empowered under that Act to perform the duties imposed thereby on a 56[Commissioners of Customs] and other officers of Customs, shall have the same powers in respect of such drugs 55[and cosmetics] as they have for the time being in respect of such goods as aforesaid.

57[(2) Without prejudice to the provisions of sub-section (1), the 56[Commissioner of Customs] or any officer of the Government authorized by, the Central Government in this behalf, may detain any imported package which he suspects to contain any drug 55[or cosmetic] the import of which is prohibited under this Chapter and shall forthwith report such detention to the Drugs Controller. India, and, if necessary, forward the package or sample of any suspected drug 55[or cosmetic] found therein to the Central Drugs Laboratory.]



12. Power of Central Government to make rules

(1) The Central Government may, 58[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:

59[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) specify the drugs or classes of drugs 60[or cosmetics or classes of cosmetics] for the import of which a license is required, 61[and prescribe the form and conditions of such licenses, the authority empowered to issue the same, the fees payable therefor and provide f or the cancellation, or suspension of such license in any case where any provision of this Chapter or the rules made thereunder is contravened or any of the conditions subject to which the license is issued is not complied with];

(b) prescribe the methods of test or analysis to be employed in determining whether a drug 60[or cosmetic] is of standard quality;

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

62[(cc) prescribe under clause (d) of 63[section 9A] the colour or colors which a drug may bear or contain for purposes of coloring;]

(d) specify the diseases or ailments which an imported drug may not purport or claim 64[to prevent, cure or mitigate] and such other effects which such drug may not purport or claim to have;

(e) prescribe the conditions subject to which small quantities of drugs, the import of which is otherwise prohibited under this Chapter, may, be imported for the purpose of examination, test or analysis or for personal use;

(f) prescribe the places at which drugs 60[or cosmetics] may be imported, and prohibit their import at any other place;

(g) require the date of manufacture and the date of expiry of potency to be clearly and truly stated on the label or container of any specified imported drug or class of such drug, and prohibit the import of the said drug or class of drug after the expiry of a specified period from the date of manufacture:

(h) regulate the submission by importers, and the securing, of samples of drugs 60[or cosmetics] for examination, test or analysis by the Central Drugs Laboratory, and prescribe the fees, if any, payable for such examination, test or analysis.,

(i) prescribe the evidence to be supplied, whether by accompanying documents or otherwise, of the quality of drugs 60[or cosmetics] sought to be imported, the procedure of officers of Customs in dealing with such evidence, and the manner of storage at places of import of drugs 60[or cosmetics] detained pending admission;

(j) provide for the exemption,. conditionally or otherwise, from all or any of the provisions of this Chapter and the rules made thereunder of drugs 60[or cosmetics] imported for the purpose only of transport through, .and export from, 28[India];

(k) prescribe the conditions to be observed in the packing in bottles, packages or other containers, of imported drugs 60[or cosmetics] 65[including the use of packing material which comes into direct contact with the drugs].

(l) regulate the mode of labeling drugs 60[or cosmetics] imported for sale in packages, and prescribe the matters which shall or shall not be included in such labels;

(m) prescribe the maximum proportion of any poisonous substance which may be added to or contained in any imported drug, prohibit the import 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;

(n) require that the accepted scientific name of any specified drug shall be displayed in the prescribed manner on the label or wrapper of any imported, patent or proprietary medicine containing such drug;

(o) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made thereunder of any specified drug or class of drugs 60[or cosmetic or class of cosmetics].



13. Offences

(1) Whoever himself or by any other person on his behalf imports,-

(a) any drug deemed to be adulterated under section 9A or deemed to be a spurious drug under section 9B or any spurious cosmetic referred to in section 9D or any cosmetic of the nature referred to in clause (ee) of section 10 shall be punishable with imprisonment for a term which may extend to three years and a fine which may extend to five thousand rupees;

(b) any drug or cosmetic other than a drug or cosmetic referred to in clause (a), the import of which is prohibited under section 10, or any rule made under this Chapter, shall be punishable with imprisonment for a term which may extend to six months, or with fine which may extend to five hundred rupees, or with both.

(c) any drug or cosmetic in contravention of the provisions of any notification issued under section 10A, shall be punishable with imprisonment for a term which may extend to three years, or with fine which may extend to five thousand rupees, or with both.;

(2) Whoever having been convicted of an offence-

(a) under clause (a) or clause (c) of sub-section (1), is again convicted of an offence under that, clause, shall be punishable with imprisonment for a term which may extend to five years, or with fine which may extend to ten thousand rupees, or with both.;

(b) under clause (b) of sub-section (1), is again convicted of an offence under that clause, shall punishable with imprisonment for a term which may extend to one year, or with fine which may extend to one thousand rupees, or with both.

(3) The punishment provided by this section shall be in addition to any penalty to which the offender may be liable under the provisions of section 11.]



14. Confiscation

Where any offence punishable under section 13 has been committed, the consignment of the drugs 67[or cosmetics] in respect of which the offence has been committed shall be liable to confiscation.



15. Jurisdiction

No Court inferior to that 68[of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under section 13. 



16. Standards of quality

70[(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 71[the Second Schedule], and

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

(2) The 72[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 71[the Second Schedule] for the purposes of this Chapter, and thereupon 71[the Second Schedule] shall be deemed to be amended accordingly.



17. Misbranded drugs

For the purposes of this Chapter, a drug shall be deemed to be misbranded,-

(a) if it is so colored, 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 labeled in the prescribed manner; or

(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.



17A. Adulterated drugs

For the 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 fifth or whereby it may have been rendered injurious to health; or

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of coloring only, a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.



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 labeled 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 reveal its true character and its lack of identity with such other cosmetic; or

(c) if the label or container bears the name of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist; or

(d) if it purports to be the product of a manufacturer of whom it is not truly a product.]



18. Prohibition of manufacture and sale of certain drugs and cosmetics

From such 74date 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) 75[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute-

76[(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious;

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

77[(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof 75[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 78[to prevent, cure or mitigate] any such disease or ailment, or to have any such other effect as may be prescribed;

79[(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) 75[sell or stock or exhibit or offer for sale,] or distribute any drug 80[or cosmetic] which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made thereunder;

(c) 75[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute any drug 81[or cosmetic], except under, and in accordance with the conditions of, a license 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 82[Central Government] may, after consultation with the Board, by notification in the Official Gazette permit, subject to any conditions specified in the notification, the 83[manufacture for sale or for distribution, sale, stocking or exhibiting or offering for sale] or distribution of any drug or class of drugs not being of standard quality.



18A. Disclosure of the name of the manufacturer, etc.

Every person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the name, address and other particulars of the person from whom he acquired the drug or cosmetic.]



18B. Maintenance of records and furnishing of information

Every person holding a license 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 and such information as is required by such officer or authority for carrying out the purpose of this Act.]



19. Pleas

(1) Save as hereinafter provided in this section, it shall be no defense in a prosecution under this Chapter to prove merely that the accused was ignorant of the nature, substance or quality of the drug 87[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) 88[For the purposes of section 18 a drug shall not be deemed to be misbranded or 89[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 87[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 87[or cosmetic] or to conceal its inferior quality or other defects; or

90[***]

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

91[(3) A person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall not be liable for a contravention of section 18 if he proves-

(a) that he acquired the drug or cosmetic from a duly licensed manufacturer, distributor or dealer thereof;

(b) that he did not know and could not, with reasonable diligence, have ascertained that the drug or cosmetic in any way contravened the provisions of that section; and

(c) that the drug or cosmetic, while in his possession was properly stored and remained in the same state as when he acquired it.]



20. Government Analysis

(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 93[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 Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts in respect of such drugs or 93[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.

94[(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 prescribed.

(2) The powers which may be exercised by an Inspector and the duties which may be performed by him, the drugs or 95[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 96[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, and shall be officially sub-ordinate to such authority 97[, having the prescribed qualifications,] as the Government appointment him may specify in this behalf.]



22. Powers of Inspectors

(1) Subject to the provisions of section 23 and of any rules made by the Central Government in this behalf, an Inspector may, within the local limits of the area for which he is appointed,-

99[(a) inspect,-

(i) any premises wherein any drug or cosmetic is being manufactured and the means employed for standardizing and testing the drug or cosmetic;

(ii) any premises wherein any drug or cosmetic is being sold, or stocked or exhibited or offered for sale. or distributed;

(b) take samples of. any drug or cosmetic,-

(i) which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed;

(ii) from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee;

(c) at all reasonable times, with such assistance, if any, as he considers necessary,-

(i) search any person, who, he has reason to believe, has secreted about his person, any drug or cosmetic in respect of which an offence under this Chapter has been, or is being, committed, or

(ii) enter and search any place, in which he has reason to believe 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;]

100[(cc) examine any record, register, document or any other material object found 101[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;]

102[(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 103[the Code of Criminal Procedure, 1973] shall, so far 2 of 1974 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 104[section 94] of the said Code.

102[(2A) Every record, register or other document seized under clause (cc) or produced under clause (cca) shall be returned to the person, from whom they were seized or who produce the same, within a period of twenty days of the date of such seizure or production, as the case may be, after copies thereof or extracts there from certified by that person, in such manner as may be prescribed, have been taken.]

(3) If any person willfully obstructs an Inspector in the exercise of the powers conferred upon him by or under this Chapter 102[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

Where an Inspector takes any sample of a drug 87[or cosmetic] under this Chapter, he shall tender the fair price thereof and may require a written acknowledgement therefor.

(2) Where the price tendered under sub-section (1) is refused, or where the Inspector seizes the stock of any drug 87[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 87[or cosmetic] for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he willfully absents himself, shall divide the sample into four portions and effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or any of the- portions so sealed and marked:

Provided that where the sample is taken from premises whereon the drug 87[or cosmetic] is being manufactured, it shall be necessary to divide the sample into three portions only :

Provided further that where the drug 87[or cosmetic] is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug 87[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 or 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 87[or cosmetic]; and

105[(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 dispatch in ascertaining whether or not the drug 87[or cosmetic] contravenes any of the provisions of section 18 and, if it is ascertained that the drug 87[or cosmetic] does not so contravene, forthwith revoke the order passed under the said clause or, as the case may be, take such action as may be necessary for the return of the stock seized;

(b) if he seizes the stock of the drug 87[or cosmetic], he shall as soon as may be inform 106[a Judicial Magistrate] and take his orders as to the custody thereof;

(c) without prejudice to the institution of any prosecution, if the alleged contravention be such that the defect may be remedied by the possessor of the drug 87[or cosmetic], he shall, on being satisfied that the defect has been so remedied, forthwith revoke his order under the said clause.

107[(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 106[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 87[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 87[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 87[or cosmetic] Government 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 108[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 109[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 of 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 analyzed in the Central Drugs Laboratory, where a person has under subsection (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 87[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. Purchase of drug or cosmetic enabled to obtain test or analysis

Any person 110[or any recognized 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 87[or cosmetic] 111[purchased by him or it] and to receive a report of such test or analysis signed by the Government Analyst.

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



26A. 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, prohibit the manufacture, sale or distribution of such drug or cosmetic.]



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

Whoever, himself or by any other person on his behalf, manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes,-

(a) any drug deemed to be adulterated under section 17A or spurious under section 17B or which when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous hurt within the meaning of section 320 of the Indian Penal Code solely on account of such drug being adulterated or spurious or not or standard quality, as the case may be, shall be punishable with imprisonment for a term which shall not be less than five years but which may extend to a term of life and with fine which shall not be less than ten thousand rupees;

(b) any drug-

(i) deemed to be adulterated under section 17A, but not being a drug referred to in clause (a), or

(ii) without a valid license as required under clause (c) of section 18, shall be punishable with imprisonment for a term which shall not be less than, one year but which may extend to three years and with fine which shall not be less than five thousand rupees;

Provided that the Court may, for, any adequate and special reasons to be recorded in the judgment, impose a sentence of imprisonment for a term of less than one year and of fine of less than five thousand rupees;

(c) any drug deemed to be spurious under section 17B, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and with fine which shall not be less than five thousand rupees:

Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment, impose a sentence of imprisonment for a term of less than three years but not less than one year ;

(d) any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention of any other provision of this Chapter or any rule made thereunder, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years and with fine:

Provided that the Court may for any adequate and special reasons to be recorded in the judgment impose a sentence of imprisonment for a term of less than one year.



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

Whoever himself or by any other person on his behalf manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale-

(i) any cosmetic deemed to be spurious under section 17C shall be punishable with imprisonment for a term which may extend to three years and with fine;

(ii) any cosmetic other than a cosmetic referred to in clause (i) above in contravention of any provisions of this Chapter or any rule made thereunder shall be punishable with imprisonment for a term which may extend to one year or with fine which may extend to one thousand rupees or with both.]



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

Whoever contravenes the provisions of section 18A 116[or section 24] shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to 117[one thousand rupees], or with both.]



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

Whoever without reasonable cause or excuse, contravenes the provisions of section 18B shall be punishable with imprisonment for a term which may extend to one year or with fine which may extend to one thousand rupees or 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 Analysts 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 87[or cosmetic], shall be punishable with fine which may extend to five hundred rupees.



30. Penalty for subsequent offences

120[(1) Whoever having been convicted of an offence,-

(a) under clause (b) of section 27 is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to six years and with fine which shall not be less than ten thousand rupees:

Provided that the Court may, for any, adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than two years and of fine of less than ten thousand rupees;

(b) under clause (c) of section 27, is again convicted of an offence under that clause shall be punishable with imprisonment for a term which shall not be less than six years but which may extend to ten years and with fine which shall not be less than ten thousand rupees;

(c) under clause (d) of section 27, is again convicted of an offence under that clause shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to four years or with fine which shall not be less than five thousand rupees, or with both.]

121[(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 122[two thousand rupees], or with both.]

(2) Whoever, having been convicted of an offence under 123[***] section 29 is again convicted of an offence under the same section shall be punishable with imprisonment which may extend to 124[ten years], or with fine, or with both.]



31. Confiscation

    125[(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 126[or cosmetic] in respect of which the contravention has been made shall be liable to confiscation 127[and if such contravention is in respect of-

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

(ii) 129[manufacture for sale, or for distribution, sale, or stocking or exhibiting or offering for sale,] or distribution of any drug without a valid license 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].

130[(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 131[or is a 129[misbranded, adulterated or spurious drug or misbranded or spurious cosmetic,] such drug or, as the case may be,, such cosmetic shall be liable to confiscation.]



31A. Application of provisions to Government departments

The provisions of this Chapter except those contained in section 31 shall apply in relation to the manufacture, sale or distribution of drugs 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

(1) No prosecution under this Chapter shall be instituted except by an Inspector 133[or by the person aggrieved or by a recognized consumer association whether such person is a member of that association or not].

(2) No Court inferior to that of 134[a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under this Chapter.

(3) Nothing contained in this Chapter shall be deemed to prevent any person from being prosecuted under any other law for any act or omission which constitutes an offence against this Chapter.



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

Where, at any time during the trial of any offence under this Chapter alleged to have been committed by any person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, the Court is satisfied, on the evidence adduced before it, that such manufacturer or agent is also concerned in that offence, then, the Court may, notwithstanding anything contained 136[in sub-sections (1), (2) and (3) of section 319 of the Code of Criminal Procedure, 1973], proceed against him as though a prosecution had been instituted against him under section 32.]



33. Power of Central Government to make rules

137[(1) The Central Government may 138[after consultation with, or on the recommendation of, the Board] and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter:

Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.]

(2) Without prejudice to the generality of the foregoing power, such rules may-

(a) provide for the establishment of laboratories for testing and analyzing drugs 139[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 139[or cosmetic] is of standard quality;

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

140[(dd) prescribe under clause (d) of 141[section 17A] the colour or colors which a drug may bear or contain for purposes of coloring;]

(e) prescribe the forms of licenses 142[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 139[or of cosmetics or any specified cosmetic or class of cosmetics], the form of application for such licenses, the conditions subject to which such licenses may be issued, the authority empowered to issue the same 143[the qualifications of such authority] and the fees payable therefor; 143[and provide for the cancellation or suspension of such licenses 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];

144[(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 licenses) 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 145[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 146[or cosmetics], 144[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 146[or cosmetics] packed in contravention of .such conditions;

(j) regulate the mode of labeling packed drugs 146[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 label or wrapper of any patent or proprietary medicine containing such drug ;

147[***]

148[(n) prescribe the powers and duties of Inspectors 144[and the qualifications of the authority to which such Inspectors shall be subordinate] and 149[specify the drugs or classes of drugs or cosmetics or classes of cosmetics] in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed;]

(o) prescribe the forms of report to be given by Government Analysts, and the manner of application for test or analysis under section 26 and the fees payable therefor ;

150[(p) specify the offences against this Chapter or any rule made thereunder in relation to which an order of confiscation may be made under section 31 and]

(q) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made thereunder, of any specified drug or class of drugs 146[or cosmetic or class of cosmetics].



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

Save as otherwise provided in this Act, nothing contained in this Chapter shall apply to 10[Ayurvedic, Siddha or Unani drugs.]



33B. Application of Chapter IVA

This Chapter shall apply only to 10[Ayurvedic, Siddha and Unani] drugs.



33C. Ayurvedic and Unani Drugs Technical Advisory Board

(1) The Central Government shall, by notification in the Official Gazette and with effect from such date as may be specified therein, constitute a Board (to be called the 154[Ayurvedic, Siddha and Unani Drugs Technical Advisory Board]) to advise the Central Government and the State Governments on technical matters arising out of this Chapter and to carry out the other functions assigned to it by this Chapter.

(2) The Board shall consist of the following members, namely :-

(i) the Director General of Health Services, ex officio;

(ii) the Drugs Controller, India, ex officio;

155[(iii) the principal officer dealing with Indian systems of Medicine in the Ministry of Health, ex officio;

(iv) the Director of the Central Drugs Laboratory, Calcutta, ex officio;

(v) one person holding the appointment of Government Analyst under section 33F, to be nominated by !he Central Government;

(vi) one Pharmacognocist to be nominated by the Central Government;

(vii) one Phyto-chemist to be nominated by the Central Government;

156[(viii) four persons to be nominated by the Central Government, two from amongst the members of the Ayurvedic Pharmacopoeia Committee, one from amongst the members of the Unani Pharmacopoeia Committee and one from amongst the members of the Siddha Pharmacopoeia Committee;]

(ix) one teacher in Darvyaguna, and Bhaishaiya Kalpana, to be nominated by the Central Government;

(x) one teacher in ILM-UL-ADVIA and TAKILS-WA-DAWASAZI, to be nominated by the Central Government;

157[(xi) one teacher in Gunapadam to be nominated by the Central Government;

(xii) three persons, one each to represent the Ayurvedic, Siddha and Unani drug industry, to be nominated by the Central Government;

(xiii) three persons, one each from among the practitioners of Ayurvedic Siddha and Unani Tibb systems of medicine to be nominated by the Central Government.]

(3) The Central Government shall appoint a member of the Board as its Chairman.

(4) The nominated members of the Board shall hold office for three years but shall be eligible for renomination.

(5) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and regulating its own procedure and conduct of all business to be transacted by it.

(6) The functions of the Board may be exercised notwithstanding any vacancy therein.

(7) The Central Government shall appoint a person to be Secretary of the Board and shall provide the Board with such clerical and other staff as the Central Government considers necessary.



33D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee

(1) The Central Government may constitute an Advisory Committee to be called the Ayurvedic, Siddha and Unani Drugs Consultative Committee to advise the Central Government, the State Governments and the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board on any matter for the purpose of securing uniformity throughout India in the administration of this Act in so far as it relates to Ayurvedic, Siddha or Unani drugs.

(2) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of two persons to be nominated by the Central Government as representatives of that Government and not more than one representative of each State to be nominated by the State Government concerned.

(3) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall meet when required to do so by the Central Government and shall regulate its own procedure.



33E. Misbranded drugs

For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be misbranded-

(a) if it is so colored, 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 labeled 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.



33EE. Adulterated drugs

For the purposes of this Chapter, an Ayurvedic. Siddha or Unani drug shall be deemed to be adulterated,-

(a) if   it consists, in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health., or

(d) if it bears or contains, for purposes of coloring only, a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.

Explanation.-For the purpose of clause (a), a drug shall not be deemed to consist. in whole or in part, of any decomposed substance only by reason of the fact that such decomposed substance is the result of any natural decomposition of the drug :

Provided that such decomposition is not due to any negligence on the part of the manufacturer of the drug or the dealer thereof and that it does not render the drug injurious to health.



33EEA. Spurious drugs

For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be spurious-

(a) if it is sold, or offered or exhibited for sale. under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive, or bears upon it or upon its label or container the name of another drug, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by any other drug or substance; or

(e) if it purports to be the product of a manufacturer of whom it is not truly a product.



33EEA. Spurious drugs

For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be spurious-

(a) if it is sold, or offered or exhibited for sale. under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive, or bears upon it or upon its label or container the name of another drug, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by any other drug or substance; or

(e) if it purports to be the product of a manufacturer of whom it is not truly a product.



33EEB. Regulation of manufacture for sale of Ayurvedic, Siddha and Unani drugs

No person shall manufacture for sale or for distribution any Ayurvedic, Siddha or Unani drug except in accordance with such standards, if any, as may be prescribed in relation to that drug.



33EEC. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drugs

From such date as the State Government may, by notification in the Official Gazette, specify in this behalf, no person, either by himself or by any other person on his behalf, shall-

(a) manufacture for sale or for distribution-

(i) any misbranded, adulterated or spurious Ayurvedic, Siddha or Unani drug;

(ii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on. the label or container thereof the true list of all the ingredients contained in it; and

(iii) any Ayurvedic, Siddha or Unani drug in contravention of any of the provisions of this Chapter or any rule made thereunder;

(b) sell, stock or exhibit or offer for sale or distribute any Ayurvedic, Siddha or Unani drug which has been manufactured in contravention of any of the provisions of this Act, or any rule made thereunder;

(c) manufacture for sale or for distribution, any Ayurvedic, Siddha or Unani drug, except under, and in accordance with the conditions of, a license issued for such purpose under this Chapter by the prescribed authority;

Provided that nothing in this section shall apply to Vaidyas and Hakims who manufacture Ayurvedic, Siddha or Unani drug for the use of their own patients :

Provided further that nothing in this section shall apply to the manufacture, subject to the prescribed conditions, of small quantities of any Ayurvedic, Siddha or Unani drug for the purpose of examination, test or analysis.



33EED. Power of Central Government to prohibit manufacture, etc., of Ayurvedic, Siddha or Unani drugs in public interest

Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied on the basis of any evidence or other material available before it that the use of any Ayurvedic, Siddha or Unani drug is likely to involve any risk to human beings or animals or that any such drug does not have the therapeutic value claimed or purported to be claimed for it and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug.]



33F. Government Analysts

(1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such areas as may be assigned to them by the Central Government or the State Government, as the case may be.

(2) Notwithstanding anything contained in sub-section (1), neither the Central Government nor a State Government shall appoint as a Government Analyst any official not serving under it without the previous consent of the Government under which he is serving.

159[(3) No person who has any financial interest in the manufacture or sale of any drug shall be appointed to be a Government Analyst under this section.]



33G. Inspectors

(1) The be 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 and the conditions, limitations or restrictions subject to which such power and duties may be exercised or performed shall be such as may be prescribed.

(3) No person who has any financial interest in the manufacture or sale of any drug shall be appointed to be an Inspector under this section.

(4) Every Inspector shall be deemed to be a public servant within the meaning of section 21 of the Indian Penal Code and shall be officially sub-ordinate to such authority as the Government appointing him may specify in this behalf.



33H. Application of provisions of sections 22, 23, 24 and 25

The provisions of sections 22, 23, 24 and 25 and the rules, if any, made thereunder shall, so far as may be, apply in relation to an Inspector and a Government Analyst appointed under this Chapter as they apply in relation to an Inspector and a Government Analyst appointed under Chapter IV, subject to the modification that the references to "drug" in the said sections, shall be construed as references to 160[Ayurvedic, Siddha or Unani] drug.



33I. Penalty for manufacture, sale etc., of Ayurvedic, Siddha or Unani drug in contravention of this Chapter

Whoever himself or by any other person on his behalf-

(1) manufactures for sale or for distribution,-

(a) any Ayurvedic, Siddha or Unani drug-

(i) deemed to be adulterated under section 33EE, or

(ii) without a valid license as required under clause (c) of section 33EEC, shall be punishable with imprisonment for a term which may extend to one year and with fine which shall not be less than two thousand rupees;

(b) any Ayurvedic, Siddha or Unani drug deemed to be spurious under section 33EEA, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to three years and with fine which shall not be less than five thousand rupees :

Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than one year and of fine of less than five thousand rupees; or

(2) contravenes any other provisions of this Chapter or of section 24 as applied by section 33H or any rule made under this Chapter, shall be punishable with imprisonment for a term which may extend. to three months and with fine which shall not be less than five hundred rupees.



33J. Penalty for subsequent offences

Whoever having been convicted of an offence,-

(a) under clause (a) of sub-section (1) of section 33-I is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to two years and with fine which shall not be less than two thousand rupees;

(b) under clause (b) of sub-section (1) of section 33-I is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to six years and with fine which shall not be less than five thousand rupees;

Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than two years and of fine of less than five thousand rupees;

(c) under sub-section (2) of section 33-I is again convicted of an offence under that sub-section, shall be punishable with imprisonment for a term which may extend to six months and with fine which shall not be less than one thousand rupees.]



33K.Confiscation

Where any person has been convicted under this Chapter, the stock of the 10[Ayurvedic, Siddha or Unani] drug, in respect of which the contravention has been made, shall be liable to confiscation.



33L. Application of provisions to Government departments

The provisions of this Chapter except those contained in section 33K shall apply in relation to the manufacture for sale, sale, or distribution of any 10[Ayurvedic. Siddha or Unani] drug by any department of Government as they apply in relation to the manufacture for sale, sale, or distribution of such drug by any other person.



33M. Cognizance of offences

(1) No prosecution under this Chapter shall be instituted except by an Inspector 162[with the previous sanction of the authority specified under sub-section (4) of section 33G].

(2) No Court inferior to that 163[of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under this Chapter.



33N. Power of Central Government to make rules

(1) The Central Government may, 164[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 he consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.

(2) Without prejudice to the generality of the foregoing power, such rules may-

(a) provide for the establishment of laboratories for testing and analyzing 165[Ayurvedic, Siddha or Unani] drugs;

(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 any 165[Ayurvedic, Siddha or Unani] drug is labeled with the true list of the ingredients which it is purported to contain;

(d) specify any substance as a poisonous substance :

(e) prescribe the forms of licenses for the manufacture for sale of 165[Ayurvedic, Siddha or Unani] drugs, 166[and for sale of processed Ayurvedic, Siddha or Unani, drugs,] the form of application for such licenses, the conditions subject to which such licenses may be issued, the authority empowered to issue the same and the fees payable therefor; 166[and provide for the cancellation of suspension of such licenses in any case where any provision of this Chapter or rules made thereunder is contravened any of the conditions subject to which they are issued is not applied with];

167[(f) prescribe the conditions to be observed in the packing of Ayurvedic, Siddha and Unani drugs including the use of packing material which comes into direct contact with the drugs, regulate the mode of labeling packed drugs and prescribe the matters which shall or shall not be included in such labels;]

(g) prescribe the conditions subject to which small quantities of 165[Ayurvedic, Siddha or Unani] drugs may be manufactured for the purpose of examination, test or analysis; and

166[(gg) prescribe under clause (d) of section 33EE the colour or colors which an Ayurvedic, Siddha or Unani drug may bear or contain for purposes of coloring;

(gga) prescribe the standards for Ayurvedic, Siddha or Unani drugs under section 33EB];

(h) any other matter which is to be or may be prescribed under this Chapter.



33O. Power to amend First Schedule

The Central Government, after consultation with the Board and after giving, by notification in the Official Gazette, not less than three months' notice of it intention so to do, may, by a like notification, add to or otherwise amend the First Schedule for the purposes of this Chapter and thereupon the said Schedule shall be deemed to be amended accordingly.]



33P. Power to give directions

The Central Government may give such directions to any State Government as may appear to the Central Government to be necessary for carrying into execution in the State any of the provisions of this Act or of any rule or order made thereunder.]



34. Offences by companies

(1) Where an offence under this Act has been committed by a company, every person who at the time the offence was committed, was in charge of, company, and was responsible to the company for the conduct of the business of the company, as well as the company shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly :

Provided that nothing contained in this sub-section shall render any such person liable to any punishment provided in this Act if he proves that the offence was committed without his knowledge or that he exercised all due diligence to prevent the commission of such offence.

(2) Notwithstanding anything contained in sub-section (1), where an offence under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance of, or is attributable to any neglect on the part of, any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.

Explanation.-For the purposes of this section-

(a) "company" means a body corporate, and includes a firm or otter association of individuals; and

(b) "director" in relation to a firm means a partner in the firm.



34A. Offences by Government departments

Where an offence under Chapter IV or Chapter IVA has been committed by any department of Government, such authority as is specified by the Central Government to be in charge of manufacture, sale or distribution of drugs or where no authority is specified, the head of the department, shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly :

Provided that nothing contained in this section shall render any such authority or person liable to any punishment provided in Chapter IV or Chapter IVA, as the case may be, if such authority or person proves that the offence was committed without its or his knowledge or that such authority or person exercised all due diligence to prevent the commission of such offence.]



34AA. Penalty for vexatious search or seizure

Any Inspector exercising powers under this Act or the rules made thereunder, who,-

(a) without reasonable ground of suspicion searches any place, vehicle, vessel or other conveyance; or

(b) vexatiously and unnecessarily searches any person; or

(c) vexatiously and unnecessarily seizes any drug or cosmetic, or any substance or article, or any record, register, document or other material object. or

(d) commits, as such Inspector, any other act, to the injury of any person without having reason to believe that such act is required for the execution of his duty, shall be punishable with fine which may extend to one thousand rupees.]



35. Publication of sentences passed under this Act

(1) If any person is convicted of an offence under this Act, 173[the Court before which the conviction takes place shall, on application made to it by the Inspector, cause] the offenders name, place of residence, the offence of which he has been convicted and the penalty which has been inflicted upon him, to be published at the expense of such person in such newspapers or in such other manner as the Court may direct.

(2) The expenses of such publication shall be deemed to form part of the costs relating to the conviction. and shall be recoverable in the same manner as those costs are recoverable.



36. Magistrates power to impose enhanced penalties

Notwithstanding anything contained in 174[***] 175[the Code of Criminal Procedure, 1973], it shall be lawful for 176[any Metropolitan Magistrate or any Judicial Magistrate of the first class] to pass any sentence authorized by this Act in excess of his powers under 174[***] the said Code.



36A. Certain offences to be tried summarily

Notwithstanding anything contained in the Code of Criminal Procedure, 1973, all offences under this Act, punishable with imprisonment for a term not exceeding three years, other than an offence under clause (b) of sub-section (1) of section 33-I, shall be tried in a summary way by a Judicial Magistrate of the first class specially empowered in this behalf by the State Government or by a Metropolitan Magistrate and the provisions of sections 262 to 265 (both inclusive) of the said Code shall, as far as may be, apply to such trial :

Provided that, in the case of any conviction in a summary trial under this section, it shall be lawful for the Magistrate to pass a sentence of imprisonment for a term not exceeding one year :

Provided further that when at the commencement of, or in the course of, a summary trial under this section it appears to the Magistrate that the nature of the case is such that a sentence of imprisonment for a term exceeding one year may have to be passed or that it is, for any other reason, undesirable to try the case summarily, the Magistrate shall, after hearing the parties, record an order to that effect and thereafter recall any witness who has been examined and proceed to hear or rehear the case in the manner provided by the said Code.]



37. Protection of action taken in good faith

No suit, prosecution or other legal proceeding shall lie against any person for anything which is in good faith done or intended to be done under action in this Act.]



38. Rules to be laid before Parliament

Every rule made under this Act shall be laid as soon as may be after it is made before each House of Parliament while it is in session for a total laid before period of thirty days which may be comprised in one session or in two or more successive sessions, 179[and if, before the expiry of the session immediately following the session or the successive sessions aforesaid], both Houses agree in making any modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified form or be of no effect, as the case may be, so however that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule.] 



THE FIRST SCHEDULE

[See section 3(a)]

181[A.-AYURVEDIC AND SIDDHA SYSTEMS]

 

Serial No.

Name of Book

Ayurveda

1.

Arogya Kalpdruma

2.

Arka Prakasha

3.

Arya Bhishak

4.

Ashtanga Hridaya

5.

Ashtanga Samgraha

6.

Ayurveda Kalpadruma

7.

Ayurveda Prakasha

8.

Ayurveda Samgraha

9.

Bhaishajya Ratnavali

 

10.

Bharat Bhaishajya Ratnakara

11.

Bhava Prakasha

12.

Brihat Nighantu Ratnakara

13.

Charaka Samhita

14.

Chakra Datta

15.

Gada Nigraha

16.

Kupi Pakva Rasayana

17.

Nighantu Ratnakara

18.

Rasa Chandanshu

19.

Rasa Raja Sundara

20.

Rasaratna Samuchaya

21.

Rasatantra Sara Siddha Prayoga Samgraha

22.

Rasa Taragini

23.

Rasa Yoga Sagara

24.

Rasa Yoga Ratnakara

25.

Rasa Yoga Samgraha

26.

Rasendra Sara Samgraha

27.

Rasa Pradipika

28.

Sahasrayoga

29.

Sarvaroga Chikitsa Ratnam

30.

Sarvayoga Chikitsa Ratnam

31.

Sharangadhara Samhita

32.

Siddha Bhaishajya Manimala

33.

Siddha Yoga Samgraha

34.

Sushruta Samhita

35.

Vaidya Chintamani

36.

Vaidyaka Shabda Sindu

37.

Vaidyaka Chikitsa Sara

38.

Vaidya Jiwan

39.

Basava Rajeeyam

40.

Yoga Ratnakara

41.

Yoga Tarangini

42.

Yoga Chintamani

43.

Kashyapasamhita

44.

Bhelasamhita

45.

Vishwanathachikitsa

46.

Vrindachikitsa

47.

Ayurvedachintamani

48.

Abhinavachintamani

49.

Ayurveda-ratnakar

50.

Yogaratnasangraha

51.

Rasamrita

52.

Dravyagunanighantu

53.

Rasamanjari

54.

Bangasena

                  Siddha

55.

Siddha Vaidya Thirattu

56.

Therayar Maha Karisal

57.

Brahma Muni Karukkadai (300)

58.

Bhogar (700)

59.

Pulippani (500)

60.

Agasthiyar Paripuranam (400)

61.

Therayar Yamagam

62.

Agasthiyar Chenduram (300)

63.

Agasthiyar (1500)

64.

Athmarakshamrutham

65.

Agasthiyar Pin (80)

66.

Agasthiyar Rathna Churukkam

67.

Therayar Karisal (300)

68.

Veeramamuni Nasa Kandam

69.

Agasthiyar(600)

70.

Agasthiyar Kanma Soothiram

71.

18 Siddhars Chillarai Kovai

72.

Yogi Vatha Kaviyam

73.

Therayar Tharu

74.

Agasthiyar Vaidya Kaviyam (1500)

75.

Bala Vagadam

76.

Chimittu Rathna (Rathna ) Churukkam

77.

Nagamuni (200)

78.

Agasthiyar Chillarai Kovai

79.

Chikicha Rathna Deepam

80.

Agasthiyar Nayana Vidhi

81.

Yugi Karisal (151)

82.

Agasthiyar Vallathi (600)

83.

Therayar Thaila Varkam

182[B. UNANI TIBB SYSTEM

Serial No.

Name of book

1.

Karabadin Qadri

2.

Karabadin Kabir

3.

Karabadin Azam

4.

Ilaj-ul-Amraz

5.

Al Karabadin

6.

Biaz Kabir Vol. II

7.

Karabadin Jadid

8.

Kitab-ul-Taklis

9.

Sanat-ul-Taklis

10.

Mifta ul-Khazain

11.

Madan-ul-Aksir

12.

Makhzan-ul-murabhat



THE SECOND SCHEDULE : STANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS AND BY DRUGS MANUFACTURED FOR SALE, SOLD, STOCKED OR EXHIBITED FOR SALE OR DISTRIBUTED.

(See sections 8 and 16)

Class of drug

Standard to be complied with

1. Patent or proprietary medicines 183[other than Homeopathic medicines].

The formula or list of ingredients displayed in the prescribed manner on the label or container and such other standards as may be prescribed.

2. Substances commonly known as vaccines, sera, toxin, toxoids, anti toxins, and antigens and biological products of such nature.

The standards maintained at the International Laboratory for Biological Standards, Stantans Seruminstitut, Cophenhagen, and such further Standards Seruminstitut, Copenhagen, and such further standards of strength, quality and purity as may be prescribed.

3. Vitamins, hormones and analogous products.

The standards maintained at the International Laboratory for Biological Standards, National Institute for Medical Research, London, and such further standards of strength, quality and purity as may be prescribed.

4. Substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals.

Such standards as may be prescribed.

184[4-A,Homeopathic Medicines :

(a) Drugs included in the Homeopathic Pharmacopoeia of India.

 

Standards of identity, purity and strength specified in the edition of the Homeopathic Pharmacopoeia of India for the time being and such other standards as may be prescribed.

(b) Drugs not included in the Homeopathic of India but which are included in the Homeopathic Pharmacopoeia a of United States of America or the United Kingdom of the German Homeopathic Pharmacopoeia.

Standards of identity, purity and strength prescribed for the drugs in the edition of such Pharmacopoeia for the time being in which they are given and such other standards as may be prescribed.

(c) Drugs not included in the Homeopathic Pharmacopoeia of India or the United States of America, or the United Kingdom or the German Homeopathic Pharmacopoeia.

The formula or list of ingredients displayed in the prescribed manner on the label of the container and such other standards as may be prescribed by the Central Government.]

185[5. Other drugs :

(a) Drugs included in the India Pharmacopoeia.

 

Standards of identity, purity and strength specified in the edition of the Indian Pharmacopoeia for the time being and such other standards as may be prescribed.

In case the standards of identity, purity and strength for drugs are not specified in the edition of the Indian Pharmacopoeia for the time being in force but are specified in the edition of the Indian Pharmacopoeia immediately preceding, the standards of identity, purity and strength shall be those occurring in such immediately preceding edition of the Indian Pharmacopoeia and such other standards as may be prescribed.

(b) Drugs not included in the India Pharmacopoeia but which are included in the official Pharmacopoeia of any other country.

Standards of identity, purity and strength specified for drugs in the edition of such official Pharmacopoeia of any other country for the time being in force and such other standards as may be prescribed.

In case the standards of identity, purity and strength for drugs are not specified in the edition of such official Pharmacopoeia for the time being in force but are specified in the edition immediately preceding the standards of identity, purity and strength shall be those occurring in such immediately preceding edition of such official Pharmacopoeia and such other standards as may be prescribed.]]



Foot Notes

1. Dated 10th April, 1940. The Act has been extended to all the partially excluded areas in the State of Orissa vide Orissa Government Notification No. 3358-LSG dated the 25th August, 1941.

2 Inserted by Act No. 21 of 1962, w.e.f. 27th July, 1964.

3 Substituted by the A.O. 1950.

4 Inserted by Act No. 21 of 1962, w.e.f. 27th July, 1964.

5 The words "except the State of Jammu and Kashmir" omitted by Act No. 19 of 1972.

6 Notified date is 1st. April, 1947 vide Notification No. F. 28(10)(3) 45H(I), dated the 2nd September, 1946, GOI, 1946, Pt.I, p.1349.

Chapter IV came into force in the States of Delhi, Ajmer and Coorg on the 1st April, 1947, see ibid., Chapter III and IV came into force in the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipuron the 1st April, 1953, vide Notification No. S.R.O. 663, dated the 30th March, 1953, Gazette of India, Pt. II, Section 3, p.451.

Chapter IV came into force in the Union territory of Dadra and Nagar Haveli w.e.f. 1st August, 1968, see Notification No. ADM/Law/117(74), dated the 20th July, 1968, Gazette of India, Pt. III, Section 3, p.128.

The Act is extended to Dadra and Nagar Haveli by Reg. 6 of 1963; to Pondicherry by Reg. 7 of 1963, to Goa, Daman and Diu by Reg. 11 of 1963, and to Laccadive, Minicoy and Amindivi Islands by Reg. 8 of 1965.

7 Added by Act No. 19 of 1972.

8 Notified date is 24th August, 1974 vide Notification No. S.O. 2185, dated the 9th August, 1974, GOI, 1974, Pt. II, Section 3 (ii), p.2331.

9 Inserted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

10 Substituted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

11 Substituted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

12 Original clause (a) was relettered as clause (aa) and substituted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

13 Inserted by Act No. 21 of 1962, w.e.f. 27th July, 1964.

14 Relettered by Act No. 13 of 1964, w.e.f. 15th September, 1964.

15 Omitted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

16 Substituted by Act No. 11 of 1955, for clause (b).

17 Substituted by Act No. 68 of 1982, for sub-clause (i), w.e.f. 1st February, 1983.

18 Substituted by Act No. 13 of 1964, for the words "vermins", w.e.f. 15th September, 1964),

19 Inserted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

20 Substituted by Act No. 13 of 1964, for clause (c), w.e.f. 15th September, 1964.

21 Clause (d) omitted by Act No. 19 of 1972.

22 Substituted by Act No. 13 of 1964, for clause(e), w.e.f. 15th September, 1964.

23 Clause (bbb) Inserted by Act No. 11 of 1955.

24 Clause (bbb) relettered as clause (f) by Act No. 35 of 1960, w.e.f. 16th March, 1961.

25 Substituted by Act No. 68 of 1982, for the words "sale and distribution", w.e.f. 1st February, 1983.

26 Substituted by Act No. 21 of 1962, for the words "or packing of any drug".

27 Clauses (c), (d) and (e) relettered as clauses (g), (h) and (i) respectively by Act No. 35 of 1960, w.e.f. 16th March, 1961.

28 Substituted by Act No. 3 of 1951, for the words "the States".

29 Inserted by Act No. 21 of 1962, w.e.f. 27th July, 1964.

30 Substituted by Act No. 11 of 1955 for original clause (e).

31 Clause (f) omitted by Act No. 3 of 1951.

32 Inserted by Act No. 19 of 1972.

33 Inserted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

34 Substituted by Act No. 13 of 1964 for earlier sub-section (2), w.e.f. 15th September, 1964.

35 Substituted by Act No. 13 of 1964 for the proviso, w.e.f. 15th September, 1964.

36 Clauses (b) and (c) omitted by Act No. 11 of 1955.

37 Substituted by Act No. 13 of 1964 for the words "under Chapter IV", w.e.f. 15th September, 1964.

38 Inserted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

39 Substituted by Act No. 68 of 1982 for the heading under Chapter III, w.e.f. 1st February, 1983.

40 Substituted by Act No. 21 of 1962 for sub-section (1), w.e.f. 27th July, 1964.

41 Substituted by Act No. 13 of 1964 for the words "the Schedule", w.e.f. 15th September, 1964.

42 Substituted by Act No. 68 of 1982 for earlier section 9, w.e.f. 1st February, 1983.

43 Substituted by Act No. 68 of 1982 for sections 9A and 9B, w.e.f. 1st February, 1983.

44 1st April, 1947, for clauses (a), (b), (c), (e) and (f) and 1st April, 1949, for clause (d), see Notification No. 18-12-46-D-I, dated the 11th February, 1947, Gazette of India, 1947. Pt.1, p. 189 as amended by Notification No. F-1-2 / 48-D (I), dated the 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. 666, dated the 30th March, 1953, Gazette of India, 1953, Pt. II, See. 3, p. 451.

45 Inserted by Act No. 21 of 1962, w.e.f. 27th July, 1964.

46 Substituted by Act No. 21 of 1962 for earlier clause (b), w.e.f. 27th July, 1964.

47 Substituted by Act No. 68 of 1982, for the words "or misbranded cosmetic", w.e.f. 1st February, 1983.

48 Inserted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

49 Substituted by Act No. 68 of 1982, for the words "adulterated", w.e.f. 1st February, 1983.

50 Substituted by Act No. 11 of 1955 for clause (d).

51 Substituted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

52 The Explanation omitted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

53 Inserted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

54 Now see the Customs Act, 1962.

55 Inserted by Act No. 21 of 1962, w.e.f. 27th July, 1964.

56 Substituted by the Finance Act, 1995 (Act No. 22 of 1995) dated 26th May, 1995 for the words "Customs Collector".

57 Substituted by Act No. 11 of 1955, for earlier sub-section (2).

58 Substituted by Act No. 68 of 1982, for the words "after consultation with the Board", w.e.f..1st February, 1983.

59 Inserted by Act No. 11 of 1955.

60 Inserted by Act No. 21 of 1962, w.e.f. 27th July, 1964.

61 Substituted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

62 Inserted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

63 Substituted by Act No. 68 of 1982 for the words and figures "section 9B", w.e.f. 1st February, 1983.

64 Substituted by Act No. 11 of 1955 for the words "to cure or mitigate".

65 Substituted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

66 Substituted by Act No. 68 of 1982, for section 13, w.e.f. 1st February, 1983.

67 Inserted by Act No. 21 of 1962, w.e.f. 27th July, 1964.

68 Substituted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

69 Substituted by Act No. 68 of 1982 for the words "DRUGS", w.e.f. 1st February, 1983.

70 Substituted by Act No. 21 of 1962, for sub-section (1), w.e.f. 27th July, 1964.

71 Substituted by Act No. 13 of 1964, for the words "the Schedule", w.e.f. 15th September, 1964.

72 Substituted by Act No. 11 of 1955, for the words "State Government".

73 Substituted by Act No. 68 of 1982, for the words and figures "sections 17, 17A and 17B", w.e.f. 1st February, 1983.

74 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. I, p. 189, as amended by Notification No. F. 1-2 / 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 the 30th March, 1953, GOI, 1953, Pt. II Section 3, p. 451.

75 Substituted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

76 Substituted by Act No. 68 of 1982, for clauses (i), (ii) and (iia), w.e.f. 1st February, 1983.

77 Substituted by Act No. 11 of 1955, for sub-clause (iii).

78 Substituted for the words "to cure or mitigate".

79 Inserted by Act No. 21 of 1962, w.e.f. 27th July, 1964.

80 Substituted by Act No. 21 of 1962, for sub-clause (v), w.e.f. 27th July, 1964.

81 Inserted by Act No. 21 of 1962, w.e.f. 27th July, 1964.

82 Substituted by Act No. 11 of 1955 for the words "State Government".

83 Substituted by Act No. 68 of 1982 for the words "manufacture for sale, sale", w.e.f. 1st February, 1983.

84 The Explanation omitted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

85 Inserted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

86 Inserted by Act No. 68 of 1982, w.e.f.1st February, 1983.

87 Inserted by Act No. 21 of 1962, w.e.f.. 27th July, 1964.

88 Substituted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

89 Substituted by Act No. 68 of 1982, for the words "adulterated", w.e.f. 1st February, 1983.

90 Clause (aa) omitted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

91 Substituted by Act No. 13 of 1964 for sub-section (3), w.e.f. 15th September, 1964.

92 Substituted by Act No. 35 of 1960 for the original ss. 20 and 21, w.e.f. 16th March, 1961.

93 Substituted by Act No. 21 of 1962, for the words "class of drugs", w.e.f. 27th July, 1964.

94 Inserted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

95 Substituted by Act No. 21 of 1962, for the words "class of drugs", w.e.f. 27th July, 1964.

96 Substituted by Act No. 21 of 1962, for the words "in the manufacture, import or sale of drugs", w.e.f. 27th July, 1964.

97 Inserted by Act No. 68 of 1982, w.e.f.. 1st February, 1983.

98 Substituted by Act No. 11 of 1955 for section  22.

99 Substituted by Act No. 68 of 1982 for clauses (a), (b) and (c), w.e.f. 1st February, 1983.

100 Inserted by Act No. 35 of 1960, w.e.f. 16th March, 1961.

101 Substituted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

102 Inserted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

103 Substituted by Act No. 68 of 1982 for the words and figures "the Code of Criminal Procedure, 1898", w.e.f. 1st February, 1983.

104 Substituted by Act No. 68 of 1982 for the words and figures "section 98", w.e.f. 1st February, 1983.

105 Substituted by Act No. 13 of 1964 for clause (iii), w.e.f. 15th September, 1964.

106 Substituted by Act No. 68 of 1982 for the words "a Magistrate", w.e.f. 1st February, 1983.

107 Inserted by Act No. 35 of 1960, w.e.f. 16th March, 1961.

108 Substituted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

109 Substituted by Act No. 13 of 1964 for the words "or the said warrantor", w.e.f. 15th September, 1964.

110 Inserted by the Drugs and Cosmetics (Amendment) Act, 1986 dated 24th December, 1986.

111 Substituted by Act No. 71 of 1986 dated 24th December, 1986 for the words "purchased by him".

112 Inserted by Act No. 71 of 1986 dated 24th December, 1986.

113 Inserted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

114 Substituted by Act No. 68 of 1982 for earlier sections 27 and 27A, w.e.f. 1st February, 1983.

115 Substituted by Act No. 13 of 1964 for earlier section 28, w.e.f. 15th September, 1964.

116 Inserted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

117 Substituted by Act No. 68 of 1982 for the words "five hundred rupees", w.e.f. 1st February, 1983.

118 Inserted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

119 Substituted by Act No. 11 of 1955 for earlier section  30.

120 Substituted by Act No. 68 of 1982 for sub-section (1), w.e.f. 1st February, 1983.

121 Inserted by Act No. 21 of 1962, w.e.f. 27th July, 1964.

122 Substituted by Act No. 68 of 1982, for the words "one thousand rupees", w.e.f. 1st February, 1983.

123 The words and figures "section 28 or" omitted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

124 Substituted for the words "two years".

125 Re-numbered as sub-section (1) by Act No. 35 of 1960, w.e.f. 16th March, 1961.

126 Inserted by Act No. 21 of 1962, w.e.f. 27th July, 1964.

127 Inserted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

128 Substituted by Act No. 68 of 1982 for clause (i), w.e.f. 1st February, 1983.

129 Substituted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

130 Substituted by Act No. 21 of 1962, w.e.f. 27th July, 1964.

131 Substituted by Act No. 13 of 1964, for the words "or is a misbranded drug", w.e.f. 15th September, 1964.

132 Inserted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

133. Inserted by Act No. 71 of 1986 dated 24th December 1986.

134. Substituted by Act No. 68 of 1982 for the words "a Presidency Magistrate or of a Magistrate of the first class", w.e.f. 1st February, 1983.

135 Inserted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

136 Substituted by Act No. 68 of 1982 for the words, figures and brackets "in sub-section (1) of section 351 of the Code of Criminal Procedure, 1898", w.e.f. 1st February, 1983.

137 Substituted by Act No. 11 of 1955 for sub-section (1).

138 Substituted by Act No. 68 of 1982 for the words "after consultation with the Board", w.e.f. 1st February, 1983.

139 Inserted by Act No. 13 of 1964, w.e.f. 27th July, 1964.

140 Inserted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

141 Substituted by Act No. 68 of 1982, for the words and figures "section 17B", w.e.f. 1st February, 1983.

142 Substituted by Act No. 68 of 1982 for the words "for the manufacture for sale", w.e.f. 1st February, 1983.

143 Inserted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

144 Inserted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

145 Substituted by Act No. 11 of 1955, for the words "to cure or mitigate".

146 Inserted by Act No. 21 of 1962, w.e.f. 27th July, 1964.

147 Clause (m) omitted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

148 Substituted by Act No. 35 of 1960 for earlier clause (n), w.e.f. 16th March, 1961.

149 Substituted by Act No. 21 of 1962 for the words "the drugs or class of drugs", w.e.f. 27th July, 1964.

150 Substituted by Act No. 13 of 1964, for clause (p), w.e.f. 15th September, 1964.

151 Omitted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

152 Inserted by Act No. 13 of 1964, w.e.f. 1st February, 1969.

153 Inserted by Act No. 13 of 1964, w.e.f. 1st February, 1969.

154 Substituted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

155 Substituted by Act No. 68 of 1982 for clause (iii), w.e.f 1st February, 1983.

156 Substituted by Act No. 68 of 1982 for clause (viii), w.e.f. 1st February, 1983.

157 Substituted by Act No. 68 of 1982 for clauses (xi) and (xii), w.e.f. 1st February, 1983.

158 Substituted by Act No. 68 of 1982 for sections 33D and 33E, w.e.f. 1st February, 1983.

159 Inserted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

160 Substituted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

161 Substituted by Act No. 68 of 1982, for sections 33-I and 33J, w.e.f. 1st February, 1983.

162 Inserted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

163 Substituted by Act No. 68 of 1982 for the words "of a Presidency Magistrate or of a Magistrate of the first class", w.e.f. 1st February, 1983.

164 Substituted by Act No. 68 of 1982 for the words "after consultation with the Board", w.e.f. 1st February, 1983.

165 Substituted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

166 Inserted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

167 Substituted by Act No. 68 of 1982 for the word and brackets "clause (f)", w.e.f. 1st February, 1983.

168 Substituted by Act No. 11 of 1955 for earlier section  34.

169 Inserted by Act No. 35 of 1960, w.e.f. 16th March, 1961.

170 Section  33A re-numbered as section  33P by Act No. 13 of 1964, w.e.f. 15th September, 1964.

171 Inserted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

172 Inserted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

173 Substituted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

174 The words and figures "section 32 of omitted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

175 Substituted by Act No. 68 of 1982, for the words and figures "the Code of Criminal Procedure, 1898", w.e.f. 1st February, 1983.

176 Substituted by Act No. 68 of 1982 for the words "any Presidency Magistrate or any Magistrate of the first class", w.e.f. 1st February, 1983.

177 Inserted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

178 Inserted by Act No. 13 of 1964, w.e.f. 15th September, 1964.

179 Substituted by Act No. 68 of 1982, w.e.f. 1st February, 1983.

180 Substituted by Act No. 13 of 1964, for the Schedule, the First Schedule came into force w.e.f. 1st February, 1969 and the Second Schedule came into force, w.e.f. 15th September, 1964.

181 Substituted by Act No. 68 of 1982 for the heading "A.-AYURVEDIC (INCLUDING, SIDDHA) SYSTEM", w.e.f. 1st February, 1983.

182 Substituted by Act No. 68 of 1982 for the heading "B.- UNANI TIBB SYSTEM", w.e.f. 1st February, 1983.

183 Inserted by Notification No. S.O. 887, dated 19th March, 1966, GOI, Pt. II, Section 3 (ii), p.819.

184 Substituted by Notification No. S.O. 820, dated the 6th June, 1978, GOI, 1978, Pt. II, Section 3(ii), p.1417.

185 Substituted by Notification No. S.O. 885, dated 4th August, 1973, GOI, 1973, Pt. II, Section 3(ii), p.1643.


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