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THE DRUGS AND COSMETICS ACT, 1940 (INDIA)

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A useful article about THE DRUGS AND COSMETICS ACT, 1940 (INDIA).Full details about THE DRUGS AND COSMETICS ACT, 1940 (INDIA)

CHAPTER I-INTRODUCTORY

1. Short title, extent and commencement. – (1) This Act may be called the Drugs and Cosmetics Act, 1940.

(2) It extends to the whole of India.

(3) It shall come into force at once; but Chapter III shall take effect only from such date 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 date as the State Government may, by like notification, appoint in this behalf:

Provided that in relation to the State of Jammu and Kashmir, Chapter II shall take effect only from such date after the commencement of the Drugs and Cosmetics (Amendment) Act, 1972 (19 of 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 (2 of 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, —

(a) ” [1] [Ayurvedic Siddha or Unani] drugs” includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of [2] [disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulae described in, the authoritative books of [3] [Ayurvedic, Siddha and Unani Tibb systems of medicine, specified in the First Schedule;]

(aa) “the Board” means —

(i) in relation to [4] [Ayurvedic, Siddha or Unani drug] the [5] [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;

(aaa) “cosmetic” means any article intended to be rubbed, powered, 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, [6] [***]

(b) “drug” includes —

[7] [(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for on 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) 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, as may be specified from time to time by the Central Government by notification in the Official Gazette;] [8] [(iii) all substances intended for use as components of a drug including empty gelatin 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;

(c) “Government Analyst” means —

(i) in relation to [9] [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. [10] [*******]

(e) “Inspector” means —

(i) in relation to [11] [Ayurvedic, Sidha 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;

(f) “manufacture” in relation to and drug for cosmetic includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug or cosmetic with a view to its [12] [sale or distribution] but does not include the compounding or dispensing [13] [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;

(g) “to import”, with its grammatical variations and cognate expressions means to bring into India;

[14] [(h) “patent or proprietory medicine” means, —

(i) in relation to Ayurvedic, Sidha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by parenterate 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 authorised in this behalf by the Central Government after consultation with the Drugs Technical Advisory Board constituted under Section 5;]

(i) “prescribed” means prescribed by rules made under this Actea

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 function 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 III or Chapter IV or Chapter IVA shall be deemed to be a poisonous substance for the purposes of Chapter III or Chapter IV for Chapter IVA as the case may be.

CHAPTER II-THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORATORY AND THE DRUGS CONSULTATIVE COMMITTEE

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 of the administration of this Act and to carry out the other functions assigned to it by this Actea

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 officio;

(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 teacher 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) on person to be nominated by the Central Government from the pharmaceutical industry;

(xii) 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 :

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, person 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, established 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 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 or such cosmetics 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;

[15] [ * * * * * * * ]

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

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

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

STATE AMENDMENTS

Uttar Pradesh

In its application to the State of Uttar Pradesh, in Section 6 (1), after the existing proviso, insert the following proviso:

“Provided further that the State Government may, with the prior approval of the Central Government, direct that the functions of the Central Drugs Laboratory and of the Director may be carried out in Uttar Pradesh by such Authority and such officer respectively as may be specified by the State Government by notification in the official Gazette, and any reference in this Act to the Central Drugs Laboratory or the Director shall then be construed as a reference to such Authority or officer, as the case may be.”

[U.P. Act 47 of 1975]

West Bengal

In its application to the State of West Bengal, in Section 6 (1), after the existing proviso, insert the following proviso:

“Provided further that the State Government may, with the prior approval of the Central Government, direct that the functions of the Central Drugs Laboratory and of the Director may be carried out in West Bengal by such Authority and such officer respectively as may be specified by the State Government by notification in the official Gazette and any reference to this Act to the Central Drugs Laboratory or the Director shall then be construed to mean such Authority or officer, as the case may be.”

[W.B. Act 42 of 1973]

7. The Drugs Consultative Committee. – (1) The Central Government may constitute an advisory committee to 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 India in the admistration of this Actea

(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. Sections 5 and 7 not to apply to [16] [Ayurvedic, Siddha or Union] drugs. – Nothing contained in Section 5 and 7 shall apply to [17] [Ayurvedic, Siddha or Unani] drugs.

CHAPTER IV-MANUFACTURE, SALE AND DISTRIBUTION OF [32] [DRUGS AND COSMETICS]


16. Standards of quality. – (1) For the purposes of this Chapter, the expression “standard quality” means —(a) in relation to a drug, that the drug compiles with the standard set out in 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 the Second Schedule for the purposes of this Chapter, and thereupon the Second Schedule shall be deemed to be amended accordingly.

[33] [17. Misbranded drugs. – For the purposes of this Chapter, a drug shall be deemed to be misbranded, —

(a) if is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is ; or

(b) if it is not labelled in the prescribed manner; or

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

17A. Adulterated drugs. – For the purposes of this Chapter, a drug shall be deemed to be adulterated, —

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

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

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

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

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

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

17B. Spurious drugs. – For the purposes of this chapter, a drug shall be deemed to be spurious, —

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

(b) if it is an imitation of, or is a subtiute 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, cosmetic shall be deemed to be misbranded, —

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

(b) if it not labelled in the prescribed manner; or

(c) if the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.

17D. Spurious cosmetics. – For the purposes of this Chapter, a cosmetic shall be deemed to be spurious, —

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

(b) if it is an imitation of, or a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic unless it is plainly and conspicuously marked so as to 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 products of a manufacturer of whom it is not truly a product.]

18. Prohibition of manufacture and sale of certain drugs and cosmetics. – From such date as may be fixed by the State Government by notification in the Official Gazette in this behalf, no person shall himself or by any other person on his behalf —

(a) [34] [manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute —

[35] [(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;]

(iia) any adulterated drug]

[36] [(iii) any patent or propriety medicine unless there is displayed in the prescribed manner on the label or container thereof [37] [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 [38] [to prevent, cure or mitigate] any such disease or ailment, or to have any other effect as may be prescribed;

(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 provision of the Chapter or any rule made thereunder;

(b) [39] [sell, or stock or exhibit or offer or distribute any drug or cosmetic which has been imported or manufactured in contravention of any of the provision of this Act or any rule made thereunder]

(c) [40] [manufacture for sale or for distribution, or sell stock or distribute any drug or cosmetic, except under, and in accordance exhibit or offer for sale], or with the conditions of a licence issued for the purpose of examination, test or analysis;

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 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.

Explanation – [41] [ * * * * ]

Comments

Expression `offer for sale$ – The manner of keeping or exhibiting them in a shop would assume relevance and importance to see if they were really offered for sale. State of Karnataka v. M/s. Kannika Stores, Mysore and others. 1994 Cri.L.J. 743 = ILR (Kar) 1993 57 = 1993(1) Kant LJ 48 (Kant.)

Ayurvedic Practitioner – Is not authorized to stock Allopathic medicines. State of Punjab v. Lashkar Singh. 1992 Cri.L.J 1745 = 1992(1) Recent Cr 185 = (1992) 2 CCR 613 (P&H)

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.

[42] [18B. Maintenance of records and furnishing of information. – Every person holding a licence under clause (c) of Section 18 shall keep maintain such records registers and other documents as may be prescribed and shall furnish to any officer or authority exercising any power or discharging any function under this Act such information as is required by such officer or authority for carrying out the purposes of this Actea”]

19. Pleas. – (1) Save as hereinafter provided in this section, it shall be no defence in a prosecution under this chapter to prove merely that the accused was ignorant of the nature, substance or quality of the drug 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) For the purposes of Section 18 a drug shall not be deemed to be misbranded or [43] [adulterated or spurious] or to 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 substances or ingredient because the same is required for the manufacture or preparation of the drug 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 or cosmetic be deemed or to conceal its inferior quality or other defects; or

(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 or cosmetic occurring after the vendor or distributor became aware of such inter mixture.

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

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

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

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

STATE AMENDMENTS

Uttar Pradesh

In its application to the State of Uttar Pradesh, after Section 19, Section 19-A inserted as follows:

“19-A. Burden of proof. – When any drug or cosmetic is seized from any person under Clause (c) of Section 22 by an Inspector in the reasonable belief that such drug or cosmetic is misbranded or adulterated, the burden of proving that such drug or cosmetic is not misbranded or adulterated shall be on the person from whose possession such drug or cosmetic was seized.”

[U.P. Act 47 of 1975]

West Bengal

In its application to the State of West Bengal, after Section 19, Section 19-A inserted as under:

“19-A. Burden of proof. – When any drug or cosmetic is seized from any person in the reasonable belief that such drug or cosmetic is misbranded or adulterated the burden of proving that such drug or cosmetic is not misbranded or adulterated shall be on the person from whose possession such drug or cosmetic was seized.”

[W.B. Act 47 of 1973]

20. Government Analysts. – (1) The State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualification, to be Government Analyst for such areas in the state and in respect of such drugs or classes of drugs or such cosmetics or classes of cosmetics as may be specified in the notifications.

(2) The Central Government may also, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts in respect of such drugs or 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.

[44] [(4) No person who has any financial interest in the import, manufacture or sale of drugs or cosmetics shall be appointed to be a Government Analyst under sub-section (1) or sub-section (2) of this section.]

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

(2) powers which may be exercised by an Inspector and the duties which may be performed by him, 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 shall be such as may be prescribed.

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

(4) Every inspector shall be deemed to be a public servant within the meaning of Section 21 of the Indian Penal Code (45 of 1960) and shall be officially subordinate to such authority [45] [, having prescribed qualifications,] as the Government appointing 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, —

[46] (a) inspect, —

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

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

(b) take samples of any drug or cosmetic, —

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