In this Act, unless there is anything repugnant in the subject or context,--
(a) "adulterated drugs" means a durg--
(i) which consists in whole or in part of any filthy, putrid or decomposed substance or which contains any foreign matter, vermin, worm, rodent or insect; or
(ii) which has been manufactured, packed, or held under unsanitary conditions whereby it [has] been contaminated with dirt, filth or any other foreign matter or whereby it may have been rendered injurious to health; or
(iii) the container of which releases any poisonous or deleterious substance which may render the contents injurious to health; or
(iv) which bears or contains as an ingredient a substance other than the prescribed substance; or
(v) with which any substance has been mixed or packed so as to reduce its quality or strength or for which any substance has been substituted wholly or in part
(b) "Appellate Board" means the Board constituted under Section 9;
(c)"batch" means a quantity of any drug produced during a given cycle of manufacture;
(d) "batch number" means a designation printed on the label of a drug that identifies the batch and permits the production history of the batch, including all stages of manufacture and control, to be traced and reviewed;
(e) "Central Licensing Board" means a Board set up under Section 5;
(f) "counterfeit drug" means a drug the label' or outerpacking of which is an imitation of, or resembles or so nearly resembles as to be calculated to deceive the label or outer-packing of a drug of another manufacture;
(g) "drug" includes--
(i) any substance or mixture of substances that is manufactured, sold, stored, offered for sale or represented for internal or external use in the treatment, mitigation, prevention or diagnosis of diseases, an abnormal physical state, or the symptoms thereof in human beings or animals or the restoration, correction, or modification of organic functions in human beings or animals, not being a substance exclusively used or prepared for use in accordance with the ayurvedic, unani, homeopathic or biochemic system of treatment except those substances and in accordance with such conditions as may be prescribed;
(ii) abortive and contraceptive substances, agents and devices, surgical ligatures, sutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive plasters, gelatine capsules and antiseptic solutions;
(iii) such substances intended to be used for the destruction or repulsion of such vermin, insects, rodents and other organism as cause, carry or transmit disease in human beings or animals or for disinfectio in residential areas or in premises in which food is manufactured, prepared or kept or stored;
(iv) such pesticides as may cause health hazard to the public;
(v) any substance mentioned as monograph or as a preparation in the Pakistan Pharmacopoeia or the Pakistan National Formulary or the International Pharmacopoeia or the British Pharmacopoeia or the British Pharmaceutical Codex or the United States Pharmacopoeia or the National Formulary of the United States, whether alone or in combination with any substance exclusively used in the unani, ayurvedic, homoeopathic or biochemic system of treatment, and intended to be used for any of the purposes mentioned in sub-clauses (i), (ii) and (iii), and
(vi) any other substance which the Federal Government may, by notification in the official Gazette, declare to 'be a "drug" for the purposes of this Act;
(h) "expiry date" means the date stated on the label of a drug after which the drug is not expected to retain its claimed efficacy, safety, quality or potency or after which it is not permissible to sell the drug;
(i) "expert" means a specialist through university education and experience in the relevant field;
(j) "export", with its grammatical variations and cognate expressions, means to take out of Pakistan by sea, land or air;
(k) "generic name" means the non-proprietary, scientific or official name of a drug as approved by the Federal Government;
(l) "Government analysis" means a Federal Government Analyst or Provincial Government Analyst appointed under Section 16;
(m) "import" with its grammatic31 variations and cognate expressions means to bring into Pakistan by sea, land or air;
(n) "Inspector" means a Federal Inspector or a Provincial Inspector appointed under Section 17;
(o) "label" means a display of written, printed or graphic matter upon the immediate container, or the outside container or wrapper of a drug package;
"Labelling" means all labels and other written, printed or graphic matter accompanying any drug;
(q) "licensing authority" means such authority as may be prescribed;
(r) "manufacture", in relation to a drug, means all operations involved in the production of the drug, including processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishin and labelling with a view to its storage, 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 "to manufacture" shall be construed accordingly;
(s) "misbranded drug" means a drug--
(i) which is not labelled in the prescribed manner; or
(ii) on the label or labelling of which any word, statement or other matter or information required by the rules to appear on the label or labelling is not prominently placed with such conspicuousness (as compared with other words, statements, designs, or devices on the label or labelling) and in such terms as may render it likely to be read 'and understood by the ordinary individual under customary conditions of purchase and use; or
(iii) which is not labelled with such directions for use and such warnings against use in indications where its use may be dangerous to health, or against unsafe dosage or duration of administration or application in such manner and form as are necessary for the protection of users or as may be prescribed; or
(iv) the label or container of which, or anything accompanying which, bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular; or
(v) which is so coloured, coated, powdered or polished that damage is concealed, or which is made to appear of better or greater therapeutic value than it really is; or
(vi) which is manufactured according to the specifications of a particular pharmacopoeia or any other document as may be prescribed and the label does not bear the name of that pharmacopoeia or document;
(t) "prescribed" means prescribed by rules;
(u) "Provincial Quality Control Board" means a Board set up under Section 11;
(v) "Registration Board" means a Board set up under Section 7;
(w) "registered drug" means any drug registered under Section 7;
(x) "rules' means rules made under this Act;
(y) "Drug Court" means a Court established under Section 31;
(z) "specifications" when applied to a drug mean--
(i) such specifications as may be prescribed; or
(ii) when the specifications are not prescribed, the specifications as contained in the most recen edition of any of the following publications, namely:-
(1) the Pakistan Pharmacopoeia;
(2) the International Pharmacopoeia;
(3) the European Pharmacopoeia;
(4) the United States Pharmacopoeia;
(5) the British Pharmacopoeia;
(6) the British Pharmaceutical Codex;
(7) the United States National Formulary; and
(8) such other publication as may be prescribed
Provided that, if the specifications do not appear in the most recent edition of any such publication, the specifications appearing in the next preceding edition of such publication in whic the specifications appear shall apply; or
(iii) if no specifications are either prescribed or contained in any of the publications referred to in sub-clause
(ii), the specification approved for the purpose of registration under this Act;
(z-a) "sell" means sell, offer for sale, expose for. sale, have in possession for sale and distribution and "to sell", "sold" or "sale" shall be construed accordingly;
(z-b) "spurious drug" means a drug--
(i) which purports to be a drug but does not contain the active ingredient of that drug; or
(ii) which purports to be the product of a manufacturer, place or country of whom or of which it is not truly a product; or
(iii) which is imported or exported or sold or offered or exposed for sale under a particular name while actually it is another drug; or
(iv) the label of which bears the name of an individual or company purporting to be its manufacturer or producer which individual or company is fictitious or does not exist;
(z-c) "storage" means storage for sale and "to store" or "stored" shall be construed accordingly; and
(zz) "sub-standard drug' means a drug which is not of specifications.
(a) "adulterated drugs" means a durg--
(i) which consists in whole or in part of any filthy, putrid or decomposed substance or which contains any foreign matter, vermin, worm, rodent or insect; or
(ii) which has been manufactured, packed, or held under unsanitary conditions whereby it [has] been contaminated with dirt, filth or any other foreign matter or whereby it may have been rendered injurious to health; or
(iii) the container of which releases any poisonous or deleterious substance which may render the contents injurious to health; or
(iv) which bears or contains as an ingredient a substance other than the prescribed substance; or
(v) with which any substance has been mixed or packed so as to reduce its quality or strength or for which any substance has been substituted wholly or in part
(b) "Appellate Board" means the Board constituted under Section 9;
(c)"batch" means a quantity of any drug produced during a given cycle of manufacture;
(d) "batch number" means a designation printed on the label of a drug that identifies the batch and permits the production history of the batch, including all stages of manufacture and control, to be traced and reviewed;
(e) "Central Licensing Board" means a Board set up under Section 5;
(f) "counterfeit drug" means a drug the label' or outerpacking of which is an imitation of, or resembles or so nearly resembles as to be calculated to deceive the label or outer-packing of a drug of another manufacture;
(g) "drug" includes--
(i) any substance or mixture of substances that is manufactured, sold, stored, offered for sale or represented for internal or external use in the treatment, mitigation, prevention or diagnosis of diseases, an abnormal physical state, or the symptoms thereof in human beings or animals or the restoration, correction, or modification of organic functions in human beings or animals, not being a substance exclusively used or prepared for use in accordance with the ayurvedic, unani, homeopathic or biochemic system of treatment except those substances and in accordance with such conditions as may be prescribed;
(ii) abortive and contraceptive substances, agents and devices, surgical ligatures, sutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive plasters, gelatine capsules and antiseptic solutions;
(iii) such substances intended to be used for the destruction or repulsion of such vermin, insects, rodents and other organism as cause, carry or transmit disease in human beings or animals or for disinfectio in residential areas or in premises in which food is manufactured, prepared or kept or stored;
(iv) such pesticides as may cause health hazard to the public;
(v) any substance mentioned as monograph or as a preparation in the Pakistan Pharmacopoeia or the Pakistan National Formulary or the International Pharmacopoeia or the British Pharmacopoeia or the British Pharmaceutical Codex or the United States Pharmacopoeia or the National Formulary of the United States, whether alone or in combination with any substance exclusively used in the unani, ayurvedic, homoeopathic or biochemic system of treatment, and intended to be used for any of the purposes mentioned in sub-clauses (i), (ii) and (iii), and
(vi) any other substance which the Federal Government may, by notification in the official Gazette, declare to 'be a "drug" for the purposes of this Act;
(h) "expiry date" means the date stated on the label of a drug after which the drug is not expected to retain its claimed efficacy, safety, quality or potency or after which it is not permissible to sell the drug;
(i) "expert" means a specialist through university education and experience in the relevant field;
(j) "export", with its grammatical variations and cognate expressions, means to take out of Pakistan by sea, land or air;
(k) "generic name" means the non-proprietary, scientific or official name of a drug as approved by the Federal Government;
(l) "Government analysis" means a Federal Government Analyst or Provincial Government Analyst appointed under Section 16;
(m) "import" with its grammatic31 variations and cognate expressions means to bring into Pakistan by sea, land or air;
(n) "Inspector" means a Federal Inspector or a Provincial Inspector appointed under Section 17;
(o) "label" means a display of written, printed or graphic matter upon the immediate container, or the outside container or wrapper of a drug package;
"Labelling" means all labels and other written, printed or graphic matter accompanying any drug;
(q) "licensing authority" means such authority as may be prescribed;
(r) "manufacture", in relation to a drug, means all operations involved in the production of the drug, including processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishin and labelling with a view to its storage, 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 "to manufacture" shall be construed accordingly;
(s) "misbranded drug" means a drug--
(i) which is not labelled in the prescribed manner; or
(ii) on the label or labelling of which any word, statement or other matter or information required by the rules to appear on the label or labelling is not prominently placed with such conspicuousness (as compared with other words, statements, designs, or devices on the label or labelling) and in such terms as may render it likely to be read 'and understood by the ordinary individual under customary conditions of purchase and use; or
(iii) which is not labelled with such directions for use and such warnings against use in indications where its use may be dangerous to health, or against unsafe dosage or duration of administration or application in such manner and form as are necessary for the protection of users or as may be prescribed; or
(iv) the label or container of which, or anything accompanying which, bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular; or
(v) which is so coloured, coated, powdered or polished that damage is concealed, or which is made to appear of better or greater therapeutic value than it really is; or
(vi) which is manufactured according to the specifications of a particular pharmacopoeia or any other document as may be prescribed and the label does not bear the name of that pharmacopoeia or document;
(t) "prescribed" means prescribed by rules;
(u) "Provincial Quality Control Board" means a Board set up under Section 11;
(v) "Registration Board" means a Board set up under Section 7;
(w) "registered drug" means any drug registered under Section 7;
(x) "rules' means rules made under this Act;
(y) "Drug Court" means a Court established under Section 31;
(z) "specifications" when applied to a drug mean--
(i) such specifications as may be prescribed; or
(ii) when the specifications are not prescribed, the specifications as contained in the most recen edition of any of the following publications, namely:-
(1) the Pakistan Pharmacopoeia;
(2) the International Pharmacopoeia;
(3) the European Pharmacopoeia;
(4) the United States Pharmacopoeia;
(5) the British Pharmacopoeia;
(6) the British Pharmaceutical Codex;
(7) the United States National Formulary; and
(8) such other publication as may be prescribed
Provided that, if the specifications do not appear in the most recent edition of any such publication, the specifications appearing in the next preceding edition of such publication in whic the specifications appear shall apply; or
(iii) if no specifications are either prescribed or contained in any of the publications referred to in sub-clause
(ii), the specification approved for the purpose of registration under this Act;
(z-a) "sell" means sell, offer for sale, expose for. sale, have in possession for sale and distribution and "to sell", "sold" or "sale" shall be construed accordingly;
(z-b) "spurious drug" means a drug--
(i) which purports to be a drug but does not contain the active ingredient of that drug; or
(ii) which purports to be the product of a manufacturer, place or country of whom or of which it is not truly a product; or
(iii) which is imported or exported or sold or offered or exposed for sale under a particular name while actually it is another drug; or
(iv) the label of which bears the name of an individual or company purporting to be its manufacturer or producer which individual or company is fictitious or does not exist;
(z-c) "storage" means storage for sale and "to store" or "stored" shall be construed accordingly; and
(zz) "sub-standard drug' means a drug which is not of specifications.
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