Drug and Cosmetic Act 1940 - I

7/31/2019 Drug and Cosmetic Act 1940 - I

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Presented by: D. J. Vaishnav


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An Act to regulate the import, manufacture,distribution and sale of drugs & cosmetics.

PASSED BY THE INDIAN LEGISLATURE

Received the assent of the Governor General onthe 10thApril, 1940


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As Amended by Act No. II of 1955

PASSED BY THE INDIAN PARLIAMENT

Received the assent of the President on the 15thApril, 1955

As Amended by Act No. 35 of 1960


Received the assent of the President on the 15thSeptember, 1960


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Received the assent of the President on the 27thJune, 1962



Received the assent of the President on the12th May, 1964


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As Amended by Act No.19 of 1972


Received the assent of the President on the 31stMay, 1972

As Amended by Act No.68 of 1982


Received the assent of the President on the 13thNovember, 1982


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Received the assent of the President on the24th December, 1986

As Amended by Act 22 of 1995



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Introductory


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This Act may be called the Drugs1 [and Cosmetics]Act, 1940.

It extends to the whole of India2

It shall come into force at once*

1 Ins. By Act 21of 1962, s. 2(w.e.f. 27-7-1964)2

The words except the State of Jammu & Kashmiromitted by Act 19 of 1972, s .2.* The act was come into force at different time in

different states and union territory.


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The provisions of this Act shall be in additionto and not in derogation of, the DangerousDrugs Act, 1930 2 of 1930,and any other law

for the time being in force.

3. .

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


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includes all medicines intended for internal orexternal use for or in the diagnosis, treatment,

mitigation or prevention of5[disease or disorder in

human beings or animals, and manufactured]exclusively in accordance with the formulae

described in, the authoritative books of Ayurvedic,

Siddha6 and Unani (Tibb) systems of medicine],

specified in the First Schedule;]

5 Ins. by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964).

6 Amended as per Act 68 of 1982 (w.e.f. 01-02-1983).


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1) In relation to Ayurvedic, Siddha2 or Unani drug,the Ayurvedic, Siddha2 or Unani Drugs TechnicalAdvisory Board] constituted under section 33C;and

2) In relation to any other drug or cosmetic, theDrugs Technical AdvisoryBoard constituted undersection 5;]

1Original cl. (a) was relettered as cl. (aa) and subs. by s. 2, ibid. (w.e.f. 15-9-1964).

2Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)


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Any article intended to be rubbed, poured,sprinkled orsprayed on, or introduced into, orotherwise applicated to, the human body or

any part thereof for cleansing, beautifying,promoting attractiveness, or altering theappearance, and includes any article intendedfor use as a component of cosmetic ,2* * * ;]

2 Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)

3 Ins. as ci. (aa) by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964).

4 Relettered by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964).


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(i) all medicines for internal or external use of human beingsoranimals and all substances intended to be used for orin the diagnosis, treatment, mitigation or prevention ofany 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 human body or intended tobe used for the destruction of6(vermin) or insects whichcause disease in human beings or animals, as may bespecified from time to time by the Central Governmentby notification in the Official Gazette;]

5Subs. by Act 11 of 1955, s. 2, for cl. (b).6Subs. By s. 2, ibid., for vermins (w.e.f. 15-9-1964).


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2[(iii) all substances intended for use ascomponents of a drug including empty gelatincapsules; and

(iv) such devices intended for internal or externaluse in the diagnosis, treatment, mitigation orprevention of disease or disorder in humanbeings or animals, as may be specified from

time to time by the Central Government bynotification in the Official Gazette, afterconsultation with the Board ;]



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(i) in relation to Ayurvedic, Siddha2 or Unanidrug, a Government Analystappointed byCentral Government or a State Government

under section 33F; and(ii) in relation to any other drug or cosmetic , aGovernment Analyst appointedby the Central

Government or a State Government undersection 20;]


7Subs. By s. 2, ibid., for cl. ( c) (w.e.f. 15-9-1964).


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1. In relation to Ayurvedic, Siddha2 or Unanidrug, an Inspector appointed bythe CentralGovernment or a State Government under

section 33G; and2. In relation to any other drug or cosmetic, an

Inspector appointed by the Central

Government or a State Government undersection 21;]1Subs. by Act 13 of 1964, s. 2, for cl. (e) (w.e.f. 15-9-1964).



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in relation to any drug 6[or cosmetic] includes any processor part of a process for making, altering, ornamenting,finishing, packing, labelling, breaking up or otherwisetreating or adopting any drug 6[or cosmetic] with a view

to its 3[sale or distribution] but does not include thecompounding or dispensing 7[of any drug, or the packingof any drug or cosmetic,] in the ordinary course of retailbusiness; and to manufacture shall be construedaccordingly;]

3Amended as per Act 68 of 1982 (w.e.f. 01-02-1983)4Cl. (bbb) ins. by Act 11 of 1955, s. 2.

5Cl. (bbb) relettered as cl. (f) by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961).

6Ins. by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964).

7Subs. by s. 4, ibid., for or the packing of any drug


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With its grammatical variations and cognateexpressions means to bring into 9[India];

8 Cls.(c), (d) and (e) relettered as cls. (g), (h) and (i) respectively by Act 35 of 1960, s. 2(w.e.f.16-3-1961).

9 Subs. by Act 3 of 1951, s. 3 and Sch., for the States.


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(i) in relation to Ayurvedic, Siddha or Unani Tibbsystems of medicine all formulationscontaining only such ingredients mentioned

in the formulae described in the authoritativebooks of Ayurveda, Siddha or Unani Tibbsystems of medicine specified in the FirstSchedule, but does not include a medicinewhich is administered by parenteral route andalso a formulation included in theauthoritative books as specified in clause (a);


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(ii) in relation to any other systems of medicine, adrug which is a remedy orprescription presentedin a form ready for internal or externaladministration of human beings or animals and

which is not included in the edition of IndianPharmacopoeia for the time being or any otherPharmacopoeia authorized in this behalf byCentral Government after consultation with the

Drugs Technical Advisory Board constitutedunder section 5;]]


8Cls.(c), (d) and (e) relettered as cls. (g), (h) and (i) respectively by Act 35 of 1960, s. 2(w.e.f.16-3-1961).


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prescribed by rules made under this Act.]

8Cls.(c), (d) and (e) relettered as cls. (g), (h) and (i) respectively by Act 35 of 1960, s. 2(w.e.f.16-3-1961).

10Subs. by Act 11 of 1955, s. 2, for original cl. (e).


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23A. Construction of references to any law not inforce or any functionary not in existence in theState of Jammu and Kashmir.

Any reference in this Act to any law which is notin force, or any functionary not in existence,in the State of Jammu and Kashmir, shall, in

relation to that State, be construed as areference to the corresponding law in force,or to the corresponding functionary inexistence, in that State.]


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Any substance specified as poisonous by rulemade under Chapter III or Chapter IV 3[orChapter IVA] shall be deemed to be a

poisonous substance for the purposes ofChapter III or Chapter IV 3[or Chapter IVA], asthe case may be.


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The drugs Technical Advisory Board, the Central Drugs Laboratoryand the Drugs Consultative Committee


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(1) The Central Government shall, as soon asmay be, constitute a Board (to be called theDrugs Technical Advisory Board) to advise

the Central Government and the StateGovernments on technical matters arisingout of the administration of this Act and tocarry out the other functions assigned to itby this Act.

(2) 4[The Board shall consist of the followingmembers, namely: --


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(i) the Director General of Health Services, exofficio, 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 Indian Veterinary Research

Institute, Izatnagar, ex officio;


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

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

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

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

(x) one person, to be elected by the Executive Committee ofthe Pharmacy Council of India, from among teachers inpharmacy or pharmaceutical chemistry orpharmacognosy on the staff of Indian University or acollege affiliated thereto;


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(xi) one person, to be elected by the ExecutiveCommittee of the Medical Council of India, from

among teachers in medicine or therapeutics on

the staff of an Indian University or a collegeaffiliated thereto;

(xii) one person to be nominated by the Central

Government from the pharmaceutical industry;

(xiii) one pharmacologist to be elected by theGoverning Body of the Indian Council of Medical

Research;


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(xiv) one person to be elected by the CentralCouncil of the Indian MedicalAssociation;

(xv) one person to be elected by the Council of the

Indian PharmaceuticalAssociation;(xvi) two persons holding the appointment of

Government Analyst under this Act, to benominated by the Central Government.]

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


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1[Provided that the person nominated or elected,as the case may be, under clause (ix) orclause (x)

or clause (xi) or clause (xvi) of sub-section (2) shall

hold office for, so long as he holds theappointment 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 fixinga quorum and regulating its own procedure and

the conduct of all business to be transacted by it.


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(5) The Board may constitute sub-committees andmay appoint to such sub-committees for suchperiods, not exceeding three years, as it maydecide, or temporarily for the consideration of

particular matters, persons who are notmembers of the board.

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

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


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1. The Central Government shall, as soon asmay be, established a Central DrugsLaboratory under the control of a Director to

be appointed by the Central Government, tocarry out the functions entrusted to it by thisAct.

2. the Central Government may, afterconsultation with the Board, make rulesprescribing


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a) the functions of the Central DrugsLaboratory

b) 2

c) 2d) the procedure for the submission to the said

Laboratory 3[under Chapter IV or ChapterIVA]of samples of drugs 1[or cosmetics] for

analysis or test, the forms of Laboratorysreports thereon and the fees payable inrespect of such reports;


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e) such other matters as may be necessary orexpedient to enable the said Laboratory tocarry out its functions.

f) the matters necessary to be prescribed forthe purpose of the proviso to subsection (1).

1Ins. by Act 21 of 1962, s. 5 (w.e.f. 27-7-1964).

2Cls. (b) and (c) omitted by Act 11 of 1955, s. 4.3Subs. by Act 13 of 1964, s. 5, for under Chapter

IV (w.e.f. 15-9-1964).


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1. The Central Government may constitute anadvisory committee to be called the DrugsConsultative Committee to advise the

Central Government, the StateGovernments and the Drugs TechnicalAdvisory Board on any other matter tendingto secure uniformity throughout 4[India] inthe administration of this Act.


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2. The Drugs Consultative Committee shallconsist of two representatives of the CentralGovernment to be nominated by that

Government and one representative of eachState Government to be nominated by theState Government concerned.

3.The Drugs Consultative Committee shallmeet when required to do so by the CentralGovernment and shall have power toregulate its own procedure.


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5[Sections 5 and 7 not apply to Ayurvedic, Siddha6

or Unani drugs.Nothing contained insections 5 and 7 shall apply to Ayurvedic,Siddha6 or Unani drugs.]

4Subs. by Act 3 of 1951, s. 3 and Sch., or theStates.

5Ins. by Act 13 of 1964, s. 6 (w.e.f. 15-9-1964).6Amended as per Act 68 of 1982 (w.e.f. 01-02-

1983)


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1[IMPORT OF DRUGS AND COSMETICS]


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(1) For the purposes of this Chapter, theexpression standardquality means

(a) in relation to a drug, that the drug complies

with the standard set out in 2[the SecondSchedule], and

(b) in relation to a cosmetic, that the cosmetic

compiles with such standard as maybeprescribed.]


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(2) The Central Government, after consultationwith the Board and after giving bynotificationin the Official Gazette not less than three

months notice of its intention so to do, mayby a like notification add to or otherwiseamend 2[the Second Schedule], for thepurpose of this Chapter, and thereupon 2[theSecond Schedule] shall be deemed to beamended accordingly.


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

1[

(a) if it is so coloured, coated, powdered or polished that

damage is concealed or ifit is made to appear ofbetter 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 thedrug bears any statement, design or device whichmakes any false claim for the drug or which is falseor misleading in any particular;

]


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-- For the purposes of this Chapter, a drug shall bedeemed 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 underinsanitary conditions whereby it may have beencontaminated with filth or whereby it may havebeen rendered injurious to health; or

(c) if its container is composed in whole or in part, ofany poisonous or deleterious substance whichmay render the contents injurious to health; or


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(d) if it bears or contains, for purposes ofcolouring only, a colour other than one which isprescribed; or

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

(f) if any substance has been mixed therewith so

as to reduce its quality orstrength.

Documents

Drug and Cosmetic Act 1940 - I