Forensic Pharmacy

Act:

The formal decision of law of legislative body.

Or

It is an enactment made by binding by the sanction of official authority.

Adulterated Drugs:

Adulterated drugs means a drug—

(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 may have 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.

Appellate Board

The Board for the disposal of appeals preferred by persons aggrieved by any decision of the central licensing board or the registration board or the Licensing Authority or a Board or

Batch:

Batch means a quantity of any drug produced during a given cycle of manufacture.

Batch Number:

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.

Counterfeit Drug:

Counterfeit drug means a drug the label' or outer packing 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.

Drug:

Drug includes--

1. 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, homoeopathic or biochemic system of treatment except those substances and in accordance with such conditions as may be prescribed,
2. Abortive and contraceptive substances, agents and devices, surgical ligatures, sutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive plasters, gelatine capsules and antiseptic solutions,
3. 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 disinfection in residential areas or in premises in which food is manufactured, prepared or kept or stored,
4. Such pesticides as may cause health hazard to the public,
5. 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 biochemical system of treatment, and intended to be used for any of the purposes mentioned in sub-clauses (i), (ii) and (iii), and,
6. Infant formulas, follow up milks, milk substitutes, baby foods , baby gruels , baby teas and juices , bottles and teats and any other product used as infant formula as such,
7. Cosmetics including hair sprays , perfumes, facial and talcum powders, hair treatment shampoos, hair conditioning aids and devices and all formulas and lotions connected therewith for conditioning and cleansing of hair , hair colours, facial makeup foundations ,vanishing and cold creams, creamy makeup sticks, bath lotions and oils, blushers and blush-ons , texture improvement devices, moisturisers of all kinds, mascaras, vaselines , surmas, wrinkle care creams, hair oils/ herbal preparations for texture and facial glow and improvement, shower creams ,skin lotions and oils, sunburn lotions and oils, shaving cream and lathers , after shave lotions ,and any other preparation or material connected therewith,  
8. 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.

The Drugs Act

An Act to regulate the import, export, manufacture, storage, distribution and sale of drugs.

Expiry Date:

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.

Expert:

Expert means a specialist through university education and experience in the relevant field.

Export:

Export with its grammatical variations and cognate expressions, means to take out of Pakistan by sea, land or air.

Forensic Pharmacy

Forensic Pharmacy is the foundation of the structure on which the sacred profession of Pharmacy has been built up in our Country. It provides much needed legal support, professional backing and ethical strength for the systematic growth of the profession. Pharmacist as a drug custodian, drug maker, drug counsellor, drug dispenser, drug analyzer, and drug educator has to discharge his duties within the orbit of professional discipline. The profession devices its strength from the legal provisions such as, Acts, Rules, Bill, Orders, and Statutes covered in Forensic Pharmacy, also known as Pharmaceutical Jurisprudence.

Generic Name:

Generic name means the non-proprietary, scientific or official name of a drug as approved by the Federal Government.

Government Analyst:

The persons appointed by Federal Government or a Provincial Government may, by notification in the official Gazette, as it thinks fit, having the prescribed qualifications, to be the Federal Government Analysts or, as the case may be, Provincial Government Analysts, for such areas and in respect of such drugs or classes of drugs as may be specified in the notification.

Investigator:

Investigator means a person engaged in the investigation, research, development or evaluation of a drug on his own initiative or under the sponsorship of any other person or an institution.

Import:

Import with its grammatica1 variations and cognate expressions means to bring into Pakistan by sea, land or air.

International non-proprietary name:

Means the name of a drug as recommended by the World Health Organization or such other name as may be notified by the Federal Government in the official Gazette.

Jurisprudence

The science and knowledge of law.

Label:

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:

Labelling means all labels and other written, printed or graphic matter accompanying any drug.

Licensing Authority:

Licensing authority means such authority as may be prescribed.

Manufacture:

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, finishing 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.

Misbranded Drug:

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.

Ordinance:

Something ordered by person(s) in authority; a law.

Pharmacopoeial Name:

Means the name of a drug as mentioned in any pharmacopoeia.

Policy:

Declaration of intent in which the Government commits itself, on the basis of a number of values and principles, to achieve a number of objectives to resolve specific problems of the sector by implementing appropriate strategies. Any policy should set the goals, objectives and strategies required to resolve the major problems identified in the sector.

Preamble:

Preface, introduction especially that of an act of parliament giving its measures and purposes.

Pakistan National Formulary:

The Federal Government shall compile and publish in the official Gazette Pakistan National Formulary comprising all drugs allowed to be imported, manufactured or sold and such Formulary may be reviewed and modified from time to time.

Rule:

1. Denotes an instruction for enforcing discipline, uniformity, and order in relation to an activity.
2. It is a fix principle or direction, regulating behavior, procedure or action.
3. A code of regulation, a guiding principle a method or process of achieving a result of control.

Regulate:

To control by rules; to keep in order.

Recipient:

Means a person or an institution who or which receives aid from the Fund

Registered Medical Practitioner:

Means a medical practitioner registered or provisionally registered under the Medical and Dental Council Ordinance, 1962.

Regulation:

Regulation is an authoritative, directive or order intended to control behavior or procedure governing rule or law.

Or

A rule or order which is prescribed by controlling authority.

 Sell:

Sell means sell, offer for sale, expose for sale, and have in possession for sale and distribution and "to sell", "sold" or "sale" shall be construed accordingly.

Specifications:

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 recent 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 which 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.

Spurious Drug:

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.

Storage:

Storage means storage for sale and "to store" or "stored" shall be construed accordingly.

Statute:

A written law expressly enacted by the legislature (law making body)

Sub-standard drug:

Sub-standard drug means a drug which is not of specifications.