Print View
এই আইন ঔষধ ও কসমেটিকস্ আইন, ২০২৩ ( ২০২৩ সনের ২৯ নং আইন ) দ্বারা রহিত করা হইয়াছে।
Chapter I
INTRODUCTORY
3. In this Act, unless there is anything repugnant in the subject or context,-
(a) “the Board” means the Drugs Technical Advisory Board constituted under section 5;
(b) “drug” includes-
(i) all medicines for internal or external use of human beings or animals, and all substances intended to be used for or in the treatment, mitigation or prevention of diseases in human beings or animals, not being medicines and substances exclusively used or prepared for use in accordance with the ayurvedic, unani, homoeopathic or biochemic system of medicine,
(ii) diagnostic, abortive and contraceptive substances, surgical ligatures, sutures, bandages, absorbent cotton, bacteriophages, adhesive plasters, gelatine capsules and antiseptic solutions,
(iii) 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 vermins or insects which cause disease in human beings or animals,
(iv) any substance, mentioned as monograph in any of the editions of the British Pharmacopoeia or the British Pharmaceutical Codex or the United States Pharmacopoeia or the National Formulary of the United States or the International Pharmacopoeia, whether alone or in combination with any substance exclusively used in the unani, ayurvedic, homoeopathic or biochemic system of medicine and intended to be used for any of the purposes mentioned in sub clauses (i), (ii) and (iii), and
(v) any other substance which the Government may, by notification in the official Gazette, declare to be a “drug” for the purposes of this Act;
2[(ba) “to export” means to take out of Bangladesh by sea, land or air;
(bb) “licensing authority” means such authority as may be prescribed;
(bc) “manufacture” in relation to any drug includes any process or part or stage of process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug with a view to its sale and distribution, but does not include the compounding and dispensing or the packing of any drug in the ordinary course of retail business or on a prescription of a registered medical practitioner or dentist or of a veterinarian, and ÔÇÿto manufacture' shall be construed accordingly;]
(c) “to import”, with its grammatical variations and cognate expressions, means to bring into Bangladesh;
(d) “patent or proprietary medicine” means a drug which is a remedy or prescription prepared for internal or external use of human beings or animals, and which is not for the time being recognised by the Permanent Commission on Biological Standardisation of the World Health Organisation or in the latest edition of the British Pharmacopoeia or the British Pharmaceutical Codex or any other pharmacopoeia authorised in this behalf by the Government after consultation with the Board;
3[(e) “prescribed” means prescribed by rules made under this Act.]
Chapter II
THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORATORY AND THE DRUGS CONSULTATIVE COMMITTEE
Chapter III
IMPORT OF DRUGS
11Chapter III A
EXPORT OF DRUGS
15B. (1) The Government may, after consultation with the Board and after previous publication by notification in the official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter.
(2) Without prejudice to the generality of the foregoing power, such rules may-
(a) specify the drugs or classes of drugs for the export of which a licence is required, and prescribe the form and conditions of such licences, the authority empowered to issue the same, and the fees payable therefore;
(b) prescribe the conditions subject to which small quantities of drugs, the export of which is otherwise prohibited under this Chapter, may be exported for the purpose of examination, test or analysis or for personal use;
(c) prescribe the places at which drugs may be exported, and prohibit their export at any other place;
(d) regulate the submission by exporters of samples of drugs for examination, test or analysis by the Central Drugs Laboratory, and prescribe the fees, if any, payable for such examination, test or analysis;
(e) prescribe the evidence to be supplied, whether by documents or otherwise, of the quality of drugs sought to be exported.
Chapter IV
MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS
Chapter V
MISCELLANEOUS