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Chapter- 1 

Chapter- 1 Preliminary
1. Short title, extent and commencement:

(1) This Act may be called as the “Drugs Act, 2035 (1978)”.
(2) This Act shall extend to the whole of Nepal.
(3) Section 1 of this Act shall come into force immediately, and other sections shall come into force in such area and on such date as Government of Nepal may, by notification in the Nepal Gazette, appoint from time to time.

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? Notifications on the commencement of the Act:
(a) Sections 3 and 4 of this Act have been appointed to commence forthwith to the whole of Nepal (the
Nepal Gazette dated 2037.3.5 (18 June 1980).
(b) Sections 2, 25, Sub-section (1) of section 34, sections 38 and 39 of this Act have been appointed to
commence forthwith to the whole of the Nepal (the Nepal Gazette dated 2040.3.13 (27 June 1983).
(c) Sections 7, 8, 9, 10, 11 and 37 of this Act have been appointed to commence to the whole of the
Nepal on 2040.12.6 (19 March 1984) (the Nepal Gazette dated 2040.12.6 (19 March 1984).
(d) Sections 20, 21, 22, 23, 24, 28, 29, 30, 33 and Sub-sections (2) and (3) of Section 34 of this Act have
been appointed to commence to the whole of the Nepal on 2043.4.1 (16 July 1986) (the Nepal
Gazette dated 2043.2.12 (26 May 1986).
(e) Sections 12, 13, 14, 15, 16, 17, 18, 19, 32, 35 and 36 o f this Act have been appointed to
commence to the whole of the Kingdom of Nepal on 2046.5.26 (11 September 1989) (the Nepal
Gazette dated 2046.5.26 (11 September 1989).
(f) Section 26 of this Act has been appointed to commence on 2049.8.1 (16 November 1992) (the
Nepal Gazette dated 2049.8.1(16 November 1992).

2. Definitions :

In this Act, Unless the subject or the context otherwise requires,-
(a) “Drug” means any substance to be used for the diagnosis, cure, mitigation, treatment or prevention of a disease in a human being, animal or bird or to be used to destruct vermin or insects which cause diseases in the human being, animal or bird or any substance used to affect the structure or any organic function of the body of a human being, animal or bird or allied ingredients or components to be used for the preparation of such substance.
(b) “Manufacture” means the process of making, preparing, refining, altering, packing, repacking or labeling a drug or any or all of the processes followed in this respect.
Provided that, this term does not include the process of dispensing, packing or repacking a drug prior to its consumption or sale.
(c) “Dispensing” means the issuing of a drug in a suitable container, appropriately labeled and compounded for its subsequent consumption by a patient.
Explanation: For purposes of this Clause, “compound” means the process of mixing two or more specific ingredients to fabricate them into a single drug.
(d) “Label” means the name and other related description of a drug written on the
container of that drug.
(e) “Doctor” means a (doctor) registered pursuant to the Nepal Medical Council Act, 2020 (1964).
(f) “Consumption” means the giving or administering of a drug either by a (doctor) or by a person authorized by the (doctor) to a patient with intention to bring about improvement in his/her physical or mental condition at that time or the taking or administering of such drug by the patient
him/herself according to the prescription written by such doctor.
(g) “Department” means the Department of Drugs Administration constituted pursuant to Section 5.
(h) “Administrator” means the Head of Department.
(i) “Inspector” means a person deputed by the Department for purposes of
Chapter-6 ♣
(j) “Prescribed” or “as prescribed” means prescribed or as prescribed in the Rules framed under this Act.

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