Drugs and Cosmetics Act, 1940 - Prohibition of manufacture and sale or certain drugs and cosmetics

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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 thereunder,

(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.

18A. Disclosure of the name of the manufacturer. – 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.

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 [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) 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 [(Note: Subs. by Act 68 of 1982, sec.16, for "adulterated" (w.e.f. 1-2-1983) adulterated or spurious] or to be below standard quality nor shall a cosmetic be deemed to be misbranded or to be below standard quality] only by reason of the fact that –

(a) There has been added thereto some innocuous substance or ingredient because the same is required for the manufacture or preparation of the drug [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) 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 [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) or cosmetic] or to conceal its inferior quality or other defects ; or

(aa) (Clauses (aa) inserted by Act 11 of 1955, sec.10, omitted by Act 13 of 1964, sec. 15 (w.e.f. 15-9-1964))

(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 [(Note: Ins. by Act 21 of 1962, sec.15 (w.e.f. 27-7-1964)) or cosmetic] occurring after the vendor or distributor became aware of such intermixture.

[(3) (Note: Subs. by Act 13 of 1964, sec.15, for sub-section (3) (w.e.f. 15-9-1964)) 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 the section; and

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

20. Government Analysts. – (1) The State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such areas in the State and in respect of such drugs or [(Note: Subs. by Act 21 of 1962, sec.16, for "classes of drugs" (w.e.f. 27-7-1964)] 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 [(Note: Subs. by Act 21 of 1962, sec.16, for "class of drugs" (w.e.f. 27-7-1964)) 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.

(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.

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rut17 

What are the regulations for compounding hormones for BHRT therapies in India. Is this legal? what regulations do compounding pharmacies in India follow?

bubai_123 

can a man selling homeopathy medicine as retailer without valid license? If so, what is punishment for that offence

rihdh.ray 

Hi, I would like to know what is the punishment of illegally running a stem cell banking in India. there are companies running stem cell banking without license, also using and promoting technologies to customer which has no approval.

san15 

Please confirm whether the drug is in JP and not in IP , is it mandatory to claim JP?

mtcgases 

there are people who are using a single liquid oxygen tank for both medical and industrial oxygen, and theboth grades liquid oxygen is being transported in the same transport tank, both the grades of oxygen are filled from the same filling manifold, even the liquid oxygen is being imported from bhutan and sold in india, Is it legal as per indian Drug Act.

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