Useful facts related to Drugs

INTRODUCTION

In 1937 a Bill was introduced in the Central Legislative Assembly to give effect to the recommendations of the Drugs Enquiry Committee to regulate the import of drugs into British India. This Bill was referred to the Select Committee and the Committee expressed the opinion that a more comprehensive measure for the uniform control of manufacture and distribution of drugs as well as of imports was desirable. The Central Government suggested to the Provincial Governments to ask the Provincial Legislatures to pass resolutions empowering the Central Legislature to pass on Act for regulating such matters relating to control of drugs as fall within the Provincial sp here. Provincial Governments got the resolution passed from the Provincial Legislatures and sent them to the Central Government for getting through the Bill to regulate the import, manufacture, distribution and sale of Drugs and Cosmetics. Thereupon the Drugs and Cosmetics Bill was introduced in the Central Legislative Assembly.

STATEMENT OF OBJECTS AND REASONS

1.   In order to give effect to the recommendations of the Drugs Enquiry Committee,, in so far as they relate to matters with which the Central Government is primarily concerned, a Bill to regulate the import of drugs into British India was introduced in the Legislative Assembly in 1937. The Select Committee appointed by the Legislative Assembly was of the opinion that a more comprehensive measure providing for the uniform control of the manufacture and distribution of drugs as well as of import was desirable. The Government of India accordingly asked Provincial Governments to invite the Provincial Legislatures to pass resolutions under section 103 of the Government of India Act, 1935, empowering the Central Legislature to pass an Act for regulating such matters relating to the control of drugs as fall within the Provincial Legislative List. Such resolutions have  now been passed by all Provincial Legislatures.

2.   Chapter II of the Bill establishes a Board of Technical Experts to advise the Central and Provincial Governments on technical matters.

3.   Chapter III provides for the control of the import of drugs into British India. The executive power under this chapter will accordingly be exercised by the Central Government.

4.   Chapter IV relates to control of the manufacture, sale and distribution of drugs and contains the provisions which it is proposed should be enacted in exercise of the powers conferred by the resolutions under section 103 of the Government of India Act passed by the Provincial Legislatures. The executive power under Chapter IV will be exercised by the Provincial Government.

5.   The First Schedule prescribes the standards to be complied with by imported drugs and the Second Schedule prescribes the standards to be complied with the drugs manufactured, sold or distributed in India. The standards prescribed in the two Schedules are identical. The Central Government will have power to amend the First Schedule, but power to amend the Second Schedule will rest with Provincial Government.

6.   The Government of India have considered to what extent provision can be made to secure the maintenance of unformity in standards and in other important matters in which uniformity is desirable. They understand that it would be ultra vires of Central Legislature to assign to any authority other than the Provincial Government's authority conferred by the Bill in respect of matters falling within the Provincial Legislative field. For this reason it is not possible to assign the power to fix standards and to make rules to any single authority. In order to assure that before any action is taken due consideration is given to the desirability of maintaining uniformity, provision has been made in Chapter VI for a single Technical Advisory Board which both Central and  Provincial Government will be required to consult before modifying the standards set up by the Bill or   before making rules under the Bill.

ACT 23 OF 1940

The Drugs and Cosmetics Bill was passed by the Central Legislative Assembly and it received the assent of the Governor General on 10th April, 1940 and thus became the Drugs and Cosmetics Act, 1940 (23 of 1940).

LIST OF AMENDING ACTS AND ADAPTATION ORDERS

1.   The Repealing and Amending Act, 1949 (40 of 1949).

2.   The Adoption of Laws Order, 1950

3.   The part B States (Laws) Act, 1951 (3 of 1951).

4.   The Drugs (Amendment) Act, 1955 (11 of 1955).

5.   The Drugs (Amendment) Act, 1960 (35 of 1960).

6.   The Drugs (Amendment) Act, 1962 (21 of 1962).

7.   The Drugs and Cosmetics (Amendment) Act, 1964 (13 of 1964).

8.   The Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972).

9.   The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982).

10.  The Drugs and Cosmetics (Amendment) Act, 1986 (71 of 1986).

3. Definitions. –

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

(a) [(Note: Ins. by Act 13 of 1964, sec.2 (w.e.f. 15-9-1964) (Note: Subs. by Act 68 of 1982, sec.2, for certain words (w.e.f. 1-2-1983). Ayurvedic, Siddha or Unani] drugs" includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of [(Note: Subs. by Act 68 of 1982, sec.3, for certain words (w.e.f. 1-2-1983) disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulate described in, the authoritative books of [ (Note: Subs. by Act 68 of 1982, sec.3, for certain words (w.e.f. 1-2-1983) Ayurvedic, Siddha and Unani Tibb system of medicine], specified in the First Schedule;]

(aa) [(Note: Original clause (a) was relettered as clause (aa) and substituted by Act 13 of 1964, sec.2 (w.e.f. 15-9-1964) "the Board" means—

(i) in relation to [ (Note: Subs. by Act 68 of 1982, sec.2, for certain words (w.e.f. 1-2-1983) Ayurvedic, Siddha or Unani] drug, the [(Note: Subs. by Act 68 of 1982, sec.3, for certain words (w.e.f. 1-2-1983) 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)]  (Note: Ins. by Act 21 of 1962, sec.4 (w.e.f. 27-7-1964)) (Note: Relettered by Act 13 of 1964, sec.2 (w.e.f. 15-9-1964))  "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 (Note: Certain words omitted by Act 68 of 1982, sec.3 (w.e.f. 1-2-1983))].

COMMENTS

(i)   It is not necessary that the article should be applied to the whole body. If it is applied to a part of the body and if it beautifies or promotes attractiveness oralters appearance then also it will be a cosmetic within the  meaning of Drugs and Cosmetics Act, 1940; State of Bombay v. Zahid  Hussain, 1975, Mah LJ. 455.

(ii)   'Gandh' and 'nail polish' are 'cosmetics' within the meaning of the Act; State of Bombay v. Zahid Hussain, 1975 Mah LJ 455.

[(b)  (Note: Subs. by Act 11 of 1955, sec.2, for clause (b))  "drug" includes –

[(i)   (Note: Subs. by Act 68 of 1982, sec.3, for sub-clause (i) (w.e.f. 1-2-1983)) 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 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 [(Note: Subs. by Act 13 of 1964, sec.2, for "vermins" (w.e.f. 15-9-1964) 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 ;]

[(iii) (Note: Ins. by Act 68 of 1982, sec.3 (w.e.f. 1-2-1983)) 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;]

COMMENTS

(i)   The definition of 'drugs' is an inclusive one. It includes all medicines for external or internal use of human beings or animals or any substances itended to be used for  or in the diagnosis, treatment, mitigation or prevention of diseases in human beings or animals; Langamurti v.State of Orissa, (1973) I CWR 368.

(ii)   The appropriate meaning of the expression 'substances' in the section is things; Chimanlal J. Sheth v.State of Maharashtra, AIR 1963 SC 665.

(iii)   Water meant to be used for  dissolving other medicines for injection into human body is 'drug'; R.C. Sundarka v. State of West bengal, 1971 Cr. LJ 1369: 77 CWN 437.

[(c) (Note: Subs. by Act 13 of 1964, sec.2, for clause (c) (w.e.f. 15-9-1964)) "Government Analyst" means –

(i) In relation to [(Note: Subs. by Act 68 of 1982, sec.2, for certain words (w.e.f. 1-2-1983)) 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;]

(d)   (Note: Clause (d) omitted by Act 19 of 1972, sec.3)

[(e)  (Note: Subs. by Act 13 of 1964, sec.2 for clause (e) (w.e.f. 15-9-1964)) "Inspector" means—

(i)   In relation to [(Note: Subs. by Act 68 of 1982, sec.2, for certain words (w.e.f. 1-2-1983)) 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;]

[(f)  (Note: Clause (bbb) ins. by Act 11 of 1955, sec.2) (Note: Clause (bbb) reentered as clause (f) by Act 35 of 1960, sec.2 (w.e.f.                  16-3-1961) "manufacture" in relation to any drug [(Note: Ins. by Act 21 of 1962, sec.4 (w.e.f. 27-7-1964)) 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 [ (Note: Ins. by Act 21 of 1962, sec.4 (w.e.f. 27-7-1964)) or cosmetic] with a view to its [(Note: Subs. by Act 68 of 1982, sec.3, for "sale and distribution" (w.e.f. 1-2-1983)) sale or distribution] but does not include the compounding or dispensing [ (Note: Subs. by Act 21 of 1962, sec.4, for "or packing of any drug".) 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)   (Note: Clauses (c), (d) and (e) reentered as clauses (g), (h) and (i) respectively by Act 35 of 1960, sec.2 (w.e.f. 16-3-1961)). "to import", with its grammatical variations and cognate expressions means to bring into [(Note: Subs. by Act 3 of 1951, sec.3 and Sch., for "the States".) India];

[(h)  (Note: Clauses (c), (d) and (e) reentered as clauses (g), (h) and (i) respectively by Act 35 of 1960, sec.2 (w.e.f. 16-3-1961)). (Note: Subs. by Act 68 of 1982, sec.3, for clause (h) (w.e.f. 1-2-1983)). "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 formulate 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 parental 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)]  (Note: Subs. by Act 11 of 1955, sec.2, for original clause (e)) (Note: Clauses (c), (d) and (e) reentered as clauses (g), (h) and (i) respectively by Act 35 of 1960, sec.2 (w.e.f. 16-3-1961)) "prescribed" means prescribed by rules made under this Act.]

(f)  (Note: Clause (f) ins. by the A.O. 1950 and omitted by Act 3 of 1951, sec.3 and Sch.)

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 Act.

[(2) (Note: Subs. by Act 13 of 1964, sec.4, for sub-section (2) (w.e.f. 15-9-1964)) 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 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 pharrmacologist 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 :

[(Note: Subs. by Act 13 of 1964, sec.4, for the Proviso (w.e.f. 15-9-1964)). Provided that the person nominated or elected, as the case may be, under clause (ix) or clause (x) or clause (xi) of 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.

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 [(Note: Ins. by Act 3 of 1951, sec.3 and Sch., for "the States") 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.


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 filth or whereby it may have been rendered injurious to health ; or

(c)   If its contained 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.

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 contained 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 only 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 purports to be the product of a manufacturer of whom it is.]

17.  Misbranded drugs. –

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

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

(b)  If it is not 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 unsanitary 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 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 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 or 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)   [(Note:  manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale, ] or distribute –

(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 ; 

(iii)  Any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof 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 [(Note: Subs. by Act 11 of 1955, sec.9, for "to cure or mitigate") to prevent, cure or mitigate] any such disease or ailment, or to have any such 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 provisions of this Chapter or any rule made there under ;

(b)   Sell or stock or exhibit or offer for sale,] or distribute any drug [(Note: Ins. by Act 11 of 1955, sec.14 (w.e.f. 27-7-1964)) or cosmetic] which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made there under,

(c)   [(Note: Subs. by Act 68 of 1982, sec.14, for certain words (w.e.f. 1-2-1983)) manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute any drug [(Note: Ins. by Act 21 of 1962, sec.14 (w.e.f. 27-7-1964)) or cosmetic], except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter.

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

Provided further that the [(Note: Subs. by Act 11 of 1955, sec.9, for "State Government") Central Government] may, after consultation with the Board by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the [(Note: Subs. by Act 68 of 1982, sec.14 (w.e.f. 1-2-1983)) 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.

COMMENTS

On a reading of section 18A and sub-section (4) of section 23 together, it is clear that out of the four portions into  which the sample has been divided one portion should be sent to the person, if any, whose name and address and other particulars have been disclosed under section 18A; In re: R.Dayalan, 1978 Cri Lj 1852. (1979) 1 FAC 29.

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 licence under clause (c) of section 18 shall keep and maintain such records, registers and other documents as may be prescribed and shall furnish to any officer or authority exercising any power or discharging any function under this Act such information as is required by such officer or authority for carrying out the purposes of this Act.

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)   The powers which may be exercised by an Inspector and the duties which may be performed by him, the drugs or [(Note: Subs. by Act 21 of 1962, sec.17 for "class of drugs" (w.e.f. 27-7-1964)) 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 [(Note: Subs. by Act 21 of 1962, sec.17, for "in the manufacture, import or sale of drugs" (w.e.f. 27-7-1964)) 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 subordinate to such authority [(Note: Ins. by Act 68 of 1982, sec.18 (w.e.f. 1-2-1983)), having the prescribed qualifications,] as the Government appointing him may specify in this behalf.]

COMMENTS

Judicial notice can be taken ofthe fact of a person being appointed as Inspector of Drugs under section 21(1) of the Act when the relevant notification published in the Official Gazette has been referred to; Ramlagun Singh v.State of Bihar, AIR 1960 Pat. 243.

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, -

(a)   [(Note: Subs. by Act 68 of 1982, sec.19, for clauses (a), (b) and (c) (w.e.f. 1-2-1983)). inspect, --

(i)    Any premises wherein any drug or cosmetic is being manufactured and the means employed for stand arising 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 ;

[(cc)  (Note: Ins. by Act 35 of 1960, sec.5 (w.e.f. 16-3-1961)) examine any record, register, document or any other material object found [(Note: Subs. by Act 68 of 1982, sec.19, for certain words (w.e.f. 1-2-1983)) 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 ;]

[(cca) (Note: Ins. by Act 68 of 1982, sec.19 (w.e.f. 1-2-1983)) 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, 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 there under.

(2)   The provisions of [(Note: Subs. by Act 68 of 1982, sec.19, for "the Code of Criminal Procedure, 1898" (w.e.f. 1-2-1983)) the Code of Criminal Procedure, 1973] shall, so far as may be, apply to any search or seizure under this Chapter as they apply to any search or seizure made under the authority of a warrant issued under [(Note: Subs. by Act 68 of 1982, sec.19, for "section 98" (w.e.f. 1-2-1983)) section 94] of the said Code.

[(2A)  (Note: Ins. by Act 68 of 1982, sec.19 (w.e.f. 1-2-1983)) Every record, register or other document seized under clause (cc) or produced under clause (cca) shall be returned to the person, from whom they were seized or who produce the same, within a period of twenty days of the date of such seizure or production, as the case may be, after copies thereof or extracts therefrom certified by that person, in such manner as may be prescribed, have been taken.]

(3)    If any person willfully obstructs an Inspector in the exercise of the powers conferred upon him by or under this Chapter [(Note: Ins. by Act 68 of 1982, sec.19 (w.e.f. 1-2-1983) 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.]

COMMENTS

(i)   An order prohibiting disposal of certain drugs is invalid and illegal because it can be issued only for specified period not exceeding twenty days under section 22(1) (c); B.K.D. Rajeshwari v. State of Kerala, AIR 1984 Ker 95.

(ii)   Since under the Drugs and Cosmetics Act a search or seizure by a Drugs Inspector is  equated to a search and seizure under the authority of a warrant, it is not necessary for a Drugs Inspector to record his reasons for making a search; Public Prosecutor v. Mahaveer Prasad, 1972 Cri LJ 1546.

23. Procedure of Inspectors. –

(1) Where an Inspector takes any sample of a drug [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) or cosmetic] under this Chapter, he shall tender the fair price thereof and may require a written acknowledgement therefore.

(2)   Where the price tendered under sub-section (1) is refused, or where the Inspector seizes the stock of any drug [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964) or cosmetic] under clause (c) of section 22, he shall tender a receipt therefore in the prescribed form.

(3)   Where an Inspector takes a sample of a drug [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964) 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 [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964) or cosmetic] is being manufactured, it shall be necessary to divide the sample into three portions only :

Provided further that where the drug [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964) or cosmetic] is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) or cosmetic] be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three or four, as the case may be, of the said containers after suitably marking the same and, where necessary sealing them.

(4)   The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same as follows :-

(i)    One portion or container he shall forthwith send to the Government Analyst for test or analysis ;

(ii)    The second he shall produce to the Court before which proceedings, if any, are instituted in respect of the drug [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) or cosmetic]; and

[(iii) (Note: Subs. by Act 13 of 1964, sec.16, for clause (iii) (w.e.f. 15-9-1964)) 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 [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) or cosmetic] contravenes any of the provisions of section 18 and, if it is ascertained that the drug [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) or cosmetic] does not so contravene, forthwith revoke the order passed under the said clause or, as the case may be, taken such action as may be necessary for the return of the stock-seized ;

(b)   If he seizes the stock of the drug [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) or cosmetic], he shall as soon as may be inform [(Note: Subs. by Act 68 of 1982, sec.20, for "a Magistrate" (w.e.f. 1-2-1983)) 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 [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) or cosmetic], he shall, on being satisfied that the defect has been so remedied, forthwith revoke his order under the said clause.

[(6) (Note: Ins. by Act 35 of 1960, sec.6 (w.e.f. 16-3-1961)) 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 [(Note: Subs. by Act 68 of 1982, sec.20, for "a Magistrate" (w.e.f. 1-2-1983)) a Judicial Magistrate] and take his orders as to the custody thereof.]

COMMENTS

(i)  As required by sub-section (4) (iii) of section 23 read with section 18A, it is the duty of the Drugs Inspector to supply to the person whose particulars are disclosed under section 18A the third portion of the sample; Agarwal Medical and General Stores v. State of M.P. AIR 1973 MP 255.

(ii)  The validity of the first proviso to section 23(3) cannot be challenged on the ground that it offends equal protection of law guaranteed by Article 14 of the Constitution as there is no purpose in having an extra portion in cases where the drug is seized from the manufacturer himself; T.Babulal v.Drugs Inspector, Madras, 1969 Cri LJ 699: (1970) 1 MLJ 124.

(iii)  When the procedure mentioned in section 23 is not followed in a case, the report of the Government Analyst cannot be treated as conclusive evidence; Dharam Deo Gupta v.State, AIR 1958 All 865: 1958 Cri LJ 1453.

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 [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) or cosmetic] is being manufactured or is kept for sale or distribution shall, on being required by any Inspector so to do, be legally bound to disclose to the Inspector the place where the drug [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) 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 [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) or cosmetic] has been submitted for test or analysis under sub-section (4) of section 23, shall deliver to the Inspector submitting it is 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 [(Note: Subs. by Act 13 of 1964, sec.17, for certain words (w.e.f. 15-9-1964)) 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 [(Note: Subs. by Act 13 of 1964, sec.17, for "or the said warrantor" (w.e.f. 15-9-1964)) or the person whose name, address and other particulars have been disclosed under section 18A] has, within twenty-eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceedings in respect of the sample are pending that he intends to adduce evidence in contravention of the report.

(4)   Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under sub-section (3) notified his intention of adducing evidence in contravention 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 [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) 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.

COMMENTS

(i)   Section 25 does not offend Article 21 of the Constitution as it has sufficiently protected the basic right of an accused to defend himself; T.Babulal v.Drugs Inspector, Madras, 1969 Cri LJ 699: (1970) 1 M LJ 124.

(ii)   There can be no prejudice to the accused if the Drugs Inspector, instead of sending the sample to the Government Analyst, sends it to a higher authority namely the Central Drugs Laboratory; Ram Shankar Misra v. State of U.P., (1980) 1 SCC 255.

(iii)   The Public Analyst can analyse the sample himself or cause it to be analysed by some other person; Bechan v.State, AIR 1966 All 91:1966 Cri LJ 122.

(iv)   It is not necessary to mention in the analysis report the methods or technological processes adopted by the Analyst; Dhian Singh v.Municipal Board, Saharanpur, AIR 1970 SC 318: (1969) 2 SCC 371.

(v)   If accused wants to call the Public Analyst as a witness it is his duty to take appropriate steps; Municipal Corporation of Delhi v. Asa Ram, 1972 Cri LJ 1651 (Del.).

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

Whoever, himself or by any other person on his behalf, manufacturers 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 of 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 licence as required under clause © 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 judgement, 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 there under, 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 judgement impose a sentence of imprisonment for a term of less than one year.

COMMENTS

The absence of any comma after the word "stocks" clearly indicates that the clause "stocks or exhibits for sale" is one indivisible whole and it contemplates not merely stocking the drugs but stocking the drugs for the purposes of sale and unless all the ingredients of this category are satisfied, section 27 of the Act would not be attracted; Mohd Shabir v. State of Maharashtra, (1979) 1 SCC 568.

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

Whoever himself or by any other person on his behalf manufacturers 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.

32. Cognizance of offences. –

(1) No prosecution under this Chapter shall be instituted except by an Inspector [(Note: Ins. by Act 71 of 1986, sec.3 (w.e.f. 15-9-1987)) or by the person aggrieved or by a recognised consumer association whether such person is a member of that association or not.]

(2)   No court inferior to that of [(Note: Subs. by Act 68 of 1982, sec.27, for "a Presidency Magistrate or of a Magistrate of the first class" (w.e.f. 1-2-1983)) 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.

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