Regarding Drug and Costmetic

Introduction

In 1937 a Bill was introduced in the Central Legislative Assembly to give effect to the recommendations of the Drug Enquiry Committee to regulate the import of drug 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 drug 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 drug 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 Drug and Cosmetics. Thereupon the Drug and Cosmetics Bill was introduced in the Central Legislative Assembly.

Objects and Reasons

• In order to give effect to the recommendations of the Drug 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 drug 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 drug 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 drug as fall within the Provincial Legislative List. Such resolutions have now been passed by all Provincial Legislatures.
• Chapter II of the Bill establishes a Board of Technical Experts to advise the Central and Provincial Governments on technical matters.

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ACT 23 OF 1940

The Drug 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 Drug and Cosmetics Act, 1940 (23 of 1940).

List of Amending Acts and Adaptation Orders

• The Repealing and Amending Act, 1949 (40 of 1949).
• The Adoption of Laws Order, 1950
• The part B States (Laws) Act, 1951 (3 of 1951).
• The Drug (Amendment) Act, 1955 (11 of 1955).
• The Drug (Amendment) Act, 1960 (35 of 1960).
• The Drug (Amendment) Act, 1962 (21 of 1962).
• The Drug and Cosmetics (Amendment) Act, 1964 (13 of 1964).
• The Drug and Cosmetics (Amendment) Act, 1972 (19 of 1972).
• The Drug and Cosmetics (Amendment) Act, 1982 (68 of 1982).
• The Drug and Cosmetics (Amendment) Act, 1986 (71 of 1986).

Definitions.

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

(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 drug" 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;

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Comments

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 Drug and Cosmetics Act, 1940; State of Bombay v. Zahid Hussain, 1975, Mah LJ. 455.

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

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Comments

The definition of 'drug' 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.

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

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The Drug Technical Advisory Board.

The Central Government shall, as soon as may be, constitute a Board (to be called the Drug 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.

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The Drug Consultative Committee

• The Central Government may constitute an advisory committee to be called "the Drug Consultative Committee" to advise the Central Government, the State Governments and the Drug 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.
• The Drug 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.
• The Drug Consultative Committee shall meet when required to do so by the Central Government and shall have power to regulate its own procedure.

Adulterated Drug

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

• If it consists, in whole or in part, of any filthy, putrid or decomposed substance ; or
• 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
• 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
• If it bears or contains, for purposes of colouring only, a colour other than one which is prescribed ; or
• If it contains any harmful or toxic substance which may render it injurious to health ; or
• If any substance has been mixed therewith so as to reduce its quality or strength.

Spurious Drug

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

• If it is imported under a name which belongs to another drug ; or
• 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
• 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
• If it has been substituted wholly or in part by another drug or substance ; or
• If it purports to be the product of a manufacturer of whom it is only truly a product.

Misbranded Cosmetics

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

• If it contains a colour which is not prescribed ; or
• If it is not labeled in the prescribed manner ; or
• If the label or container or anything accompanying the cosmetic bears any statement, which is false or misleading in any particular.

Spurious Cosmetics

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

• If it is imported under a name which belongs to another cosmetic ; or
• 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
• 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
• If it purports to be the product of a manufacturer of whom it is.

Misbranded Drug

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

• 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
• If it is not labeled in the prescribed manner ; or
• 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.

Adulterated Drug

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

• If it consists in whole or in part, of any filthy, putrid or decomposed substance ; or
• 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
• 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
• If it bears or contains, for purposes of colouring only, a colour other than one which is prescribed ; or
• If it contains any harmful or toxic substance which may render it injurious to health ; or
• If any substance has been mixed therewith so as to reduce its quality or strength.

Spurious Drug

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

• If it is manufactured under a name which belongs to another drug; or
• 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
• 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
• If it has been substituted wholly or in part by another drug or substance ; or
• If it purports to be the product of a manufacturer of whom it is not truly a product.

Misbranded Cosmetics

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

• If it contains a colour which is not prescribed ; or
• If it is not labeled in the prescribed manner ; or
• If the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.

Spurious Cosmetics

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

• If it is manufactured under a name which belongs to another cosmetic ; or
• 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
• 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
• If it purports to be the product of a manufacturer of whom it is not truly a product.

Prohibition of manufacture and sale of certain drug 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

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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.

Manufacturer Disclosure

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.

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.

Inspectors

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.

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Comments

Judicial notice can be taken ofthe fact of a person being appointed as Inspector of Drug 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.

Powers of Inspectors

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,

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Comments

• An order prohibiting disposal of certain drug 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.
• Since under the Drug and Cosmetics Act a search or seizure by a Drug Inspector is equated to a search and seizure under the authority of a warrant, it is not necessary for a Drug Inspector to record his reasons for making a search; Public Prosecutor v. Mahaveer Prasad, 1972 Cri LJ 1546.

Procedure of Inspectors

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.

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.

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Comments

• As required by sub-section (4) (iii) of section 23 read with section 18A, it is the duty of the Drug 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.
• 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.Drug Inspector, Madras, 1969 Cri LJ 699: (1970) 1 MLJ 124.
• 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 drug 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.

Reports of Government Analysts

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.

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Comments

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.Drug Inspector, Madras, 1969 Cri LJ 699: (1970) 1 M LJ 124.

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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 drug but stocking the drug 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.

Penalty for manufacture, etc., of drug 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.

Cognizance of Offences

• 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.
• 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.
• 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.