Tuesday, August 18, 2009

Pharmacy and Pharmacology

Table of Contents
Unit 3. 5
Pharmacology and Pharmacy. 5
Learning objectives: 6
1. Lesson 1: Common Definition. 6
Drugs. 6
Pharmacology. 6
Pharmacopoeia. 9
Formulary. 9
Lesson 2: Sources of drugs. 10
Activity. 10
Synthetic sources. 10
Natural sources. 10
Semi-synthetic sources. 10
Biosynthetic sources (genetically engineered drugs) 11
Lesson 3: Drug nomenclature. 11
Chemical name. 11
Generic name. 11
Trade name. 11
Lesson 4: Forms and preparations of medicines. 12
Activity. 12
Liquid. 12
Tablet 13
Capsules. 13
Topical medicines. 14
Suppositories. 14
Drops. 14
Inhalers. 15
Injections. 15
Implants or patches. 16
Buccal or sublingual tablets. 16
Lesson 5: Routes of administration of drugs. 17
Activity. 17
Topical: 18
Enteral 18
Parenteral 18
Lesson 6: Drug incompatibilities, contraindications, side effects and drug interactions. 18
Drug incompatibility. 19
Contraindications. 19
Side effects. 19
Drug interactions. 19
Conventions for avoiding confusion. 20
Lesson 7: List of abbreviations used in medical prescriptions – how to interpret medical prescriptions. 21
Lesson 8: Pharmacy. 27
Storage procedures of drugs. 30
Lesson 9: Rational Use of Drugs. 31
Lesson 10: Generic, Trade names and Actions of Drugs. 33
Concept of Autonomic Nervous System.. 33
Definition 33
Function 33
Key Terms. 33
ADRENERGIC DRUGS, (Sympathomimetics) 36
ADRENOCEPTOR ANTAGONISTS ( Sympatholytic Drugs ) 37
BETA BLOCKERS. 39
ALPHA BLOCKERS. 40
CHOLINERGIC DRUGS ( Parasympathomimetic Drugs) 42
Treatment of organophosphorus compound poisoning. 44
MUSCARINIC RECEPTOR BLOCKING DRUGS. 45
DRUGS USED IN ANGINA. 46
DIURETICS. 49
DRUGS USED IN HYPERTENSION.. 51
ANALGESICS. 55
DRUGS USED IN GOUT. 58
DRUGS USED IN CCF. 59
ANALEPTICS. 64
SEDATIVE & HYPNOTIC DRUGS. 65
ANTIHISTAMINES. 67
CORTICOSREROIDS. 69
DRUGS USED IN GIT. 71
ANTIEMETICS. 75
PURGATIVES. 77
ANTIDIARRHOEAL. 79
DRUGS USED IN RESPIRATORY SYSTEM... 323
ANTI TUSSIVE DRUGS. 323
EXPECTORANTS. 324
DRUGS USED IN ASTHMA. 325
ANTI-TUBERCULOUS DRUGS. 326
DRUGS USED IN DIBETES MELLITUS. 326
ANTIBIOTICS. 328
Categories of drugs. 330
Class room evaluation. 331
Annex 1. 336
THE DRUGS ACT. 336
Annex 2. 366
THE MEDICAL AND DENTAL DEGREES ORDINANCE (XXVI OF 1982) 366
Annex 3. 369
ALLOPATHIC SYSTEM (PREVENTION OF MISUSE) 369


Unit 3
Pharmacology and Pharmacy
Learning objectives:
After completing Unit 3, students will be able to:

a. define drugs
b. define pharmacology and the main branches of pharmacology
c. define pharmacopoeias and formularies
d. demonstrate an understanding of sources of drugs, their nomenclature and classification, their various forms and preparations
e. demonstrate an understanding of routes of administration of drugs
f. demonstrate an understanding of drug incompatibility, drug contraindications, adverse drug reactions, and interactions with human body
g. define and interpret medical prescriptions
h. demonstrate an understanding of the minimum requirements for a Pharmacy as stipulated by the Punjab Drugs Rules, 2007
i. demonstrate an understanding of storage procedures of drugs
j. appreciate the concept of Rational Use of Drugs and the need for it
k. appreciate the concept behind the National Essential Drug List of Pakistan
l. demonstrate an understanding of the reason for use for the drugs listed in the National Essential Drug List of Pakistan
m. describe the categories of drugs

Activity
Brainstorm the definition of a drug.
1. Lesson 1: Common Definition
Drugs
Drugs are chemical substances used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being
WHO (1966) definition of a drug is “any substance or product that is used or intended to be used to modify or to explore physiological system or pathological states for the benefit of the recipient.”
Pharmacology
It is the science dealing with the preparation, uses, and especially the actions of drugs in the body. It includes the different aspects of a drug’s safe usage such as its mechanism of action, doses, routes of administration, adverse affects, toxicity, drug interactions etc.
The Following are the main branches of pharmacology:
Pharmacy is a branch of pharmacology that deals with identification, selection, preservation, combining, analyzing, preparing, compounding and dispensing of medicines for administration to the patient. A pharmacist prepares compounds and dispenses medicines to the patient upon a written order of a doctor.
Pharmacy has the following branches:
Industrial pharmacy: this is related to the pharmaceutical industry, i.e. where drugs are manufactured
Community pharmacy: this refers to drug stores in the general community
Hospital pharmacy: deals with drugs used for hospital in-patients, hospital outpatient clinics and other health centers.
Pharmacognosy deals with the sources of drugs derived from natural resources i.e. plants, animals, minerals. It is also a study of physical and chemical properties of such substances.
Pharmacokinetics describes the effect of the body on the drug and deals with its absorption, distribution, metabolism and excretion. In other words, it means "What the body does to the drug". It tells what the dose of a drug should be and helps in dosage adjustment, e.g. in people who are old or in people with kidney or liver disease.
Pharmacodynamics is the study of the drug’s effect on the body (desired or toxic). In other words, it means "What the drug does to the body".
Pharmacotherapeutics deals with the use of drugs in the diagnosis, treatment or prevention of a disease or their purposeful use in alteration of physiological functions for the benefit of the recipient. In other words, it is the clinical application of the pharmacokinetic and pharmacodynamic knowledge of the drug.
Therapeutics deals with the science and art of treatment of diseases. When therapy is based on clinical evidence it is called Empirical Therapeutics. It means the drug is effective, although its mode of action is unknown.
Chemotherapy deals with the use of chemotherapeutic agents to inhibit or destroy invading germs, parasites or cancer cells with minimal effect on healthy living tissues.
Toxicology is the science of poisons. It deals with the adverse effects of drugs and poisonous effects of different chemicals.
Clinical Pharmacology is a branch of pharmacology that deals with the pharmacological effects of drugs in man. It gives useful data about the potency, usefulness, doses and toxicity of new drugs for their safe clinical use.
Pharmacopoeia
Pharmacopoeia is an official book published by the authority of a government or a medical or pharmaceutical society. It contains a selected list of the established drugs, their formulas, methods for making medicinal preparations and the average dose for adults. Each country has its own pharmacopoeia. For example:
· Pakistan Pharmacopeia
· British Pharmacopeia
· United States Pharmacopeia
· European Pharmacopeia
Formulary
It a book listing drugs, other pharmaceutical products and formulas for making medicinal preparations. Different countries have their own formulary. For example:
· Pakistan National Formulary will be compiled and published by the Federal Government of Pakistan comprising all drugs which are allowed to be imported, manufactured or sold; it will serve as a reliable prescribing and dispensing guide to all doctors and pharmacists of the country and as an effective teaching aid. The Formulary may be reviewed and modified from time to time.
· British National Formulary is published by the British Medical Association
· National Formulary is published by the American Pharmaceutical Association.
Lesson 2: Sources of drugs
Activity
Brainstorm the various sources of drugs.
Sources of drugs are as follows:
Synthetic sources
Majority of drugs used in clinical practice are synthetic, such as aspirin, chloroquine, general and local anesthetics, and paracetamol. Some advantages of synthetic drugs are:
They are chemically pure.
The process of preparing them is easier and cheaper.
Control on the quality of the drug is excellent.
Natural sources
Some drugs are obtained from natural sources, which are as follows:
Plants: Drugs could be derived from roots, leaves or barks of plants, e.g. quinine, morphine, nicotine, digoxin, caffeine.
Animals: For example, insulin used for the treatment of diabetes mellitus is extracted from pancreas of cow and other animals; and vaccines (cholera, T.B., smallpox, polio) and serum (antidiphtheria and antitetanus) are also extracted from animals.
Microbiological sources: Many life-saving drugs are obtained from fungi, moulds and bacteria e.g. penicillin and streptomycin.
Minerals: Minerals or their salts are also used as drugs. For example, ferrous sulfate is used in iron deficiency anemia and magnesium trisilicate, aluminum hydroxide and sodium bicarbonate are used as antacids for stomach hyperacidity.
Semi-synthetic sources
Sometimes semi-synthetic processes are used to prepare drugs when the synthesis of drugs may be difficult, expensive or when the natural sources may give impure compounds, e.g. semi-synthetic human insulin.
Biosynthetic sources (genetically engineered drugs)
This is relatively a new field. Some of the recent developments are genetically engineered vaccines (hepatitis-B vaccine) and recombinant DNA engineered insulins (human insulin) for diabetes mellitus.
Lesson 3: Drug nomenclature
Every drug has the following three names:
Chemical name
This name is given according to the chemical structure of a drug and indicates the exact arrangement of atoms in the molecule. However, chemical names are too difficult to be used in prescription.
Generic name
Each medicine has an approved generic name. This name does not change and is used by countries all over the world. A group of medicines that work in a similar way often have similar sounding generic names. For example, penicillin, ampicillin, and amoxycillin are the generic names for a group of antibiotics.
Trade name
The pharmaceutical company, which sells the generic drug, selects the trade name and gets it registered. The trade name then becomes the sole property of the pharmaceutical company. Several companies may make the same medicine, each with their own trade name. A product from the same company may also be called by different trade names in different countries. Trade name is usually smaller than the generic name and it is most widely used by doctors. The trade name is usually written most clearly on any packaging. However, you will always see the generic name written somewhere on the packet.
Following table gives the chemical, generic and trade name for one drug.
Chemical name
Generic name
Trade name
-chlorodihydromethyl-phenyl benzodiazepine-2-one
Diazepam
Valium® (Roche)
® is suffixed on the trade name indicating registered name.
Lesson 4: Forms and preparations of medicines
Activity
In small groups students to brainstorm the various forms of medicines.
Most medicines come in a variety of forms. Some may be more effective in one form than another or doctors prescribe medicines in a form that it easier for the patient to take it especially if the patient is a child. The different forms and preparations of medicines are:
· Liquid
· Tablet
· Capsules
· Topical medicines
· Suppositories
· Drops
· Inhalers
· Injections
· Implants or patches
· Buccal or sublingual tablets or liquids
Liquid
The active part of the medicine is combined with a liquid to make it easier to take or better absorbed. A liquid may also be called a ‘mixture’, ‘solution’ or ‘syrup’ (Figure 1).
Figure 1: a mixture bottle
Tablet
The active ingredient is combined with another substance and pressed into a round or oval solid shape. There are different types of tablet. Soluble or dispersible tablets can safely be dissolved in water, e.g. aspirin tablet. Some coated or ‘enteric’ tablets cannot be dissolved or dispersed (Figure 2).
Figure 2: tablets
Capsules
The active part of the medicine is contained inside a plastic shell that dissolves slowly in the stomach. Some capsules can be taken apart so the contents can be mixed with a favorite food. Others need to be swallowed whole so the medicine is not absorbed until the stomach acid breaks down the capsule shell (Figure 3).
Figure 3: a capsule
Topical medicines
These are creams, lotions or ointments that are applied directly onto the skin. They come in tubs, bottles or tubes depending on the type of medicine (Figure 4). The active part of the medicine is mixed with another substance that makes it easy to apply to the skin.
Figure 4: A tube containing an ointment
Suppositories
The active part of the medicine is combined with another substance and pressed into a ‘bullet shape’ so it can be inserted into the rectum. Suppositories must not be taken by mouth.
Figure 5: Different types of suppositories

Drops
These are often used where the active part of the medicine works best if it reaches the affected area directly. Drops are used for eye, ear or nose.
Figure 6: Eye drops
Inhalers
The active part of the medicine is released under pressure directly into the lungs. Young children may need to use a ‘spacer’ device to take the medicine properly.
Figure 7: Different types of inhalers
Injections
There are various types of injection, differing in how and where it is injected. Subcutaneous or SC injections are given just under the surface of the skin. Intramuscular or IM injections are given into a muscle. Intravenous or IV injections are given into a vein. Intrathecal injections are given into the fluid around the spinal cord.
Figure 8: Syringe for intramuscular injection

Implants or patches
Some medicines are absorbed by the body through the skin, such as nicotine patches for help in giving up cigarette smoking or contraceptive implants in the uterus to prevent pregnancy.

Figure 9: Placing a nicotine patch on skin
Buccal or sublingual tablets
These look similar to normal tablets or liquids but they are not swallowed. Buccal medicines are held in the cheek so that the mouth lining absorbs the active ingredient. Sublingual medicines work in the same way but are put underneath the tongue.
Figure 10: Placing sublingual tablets under the tongue
Lesson 5: Routes of administration of drugs
Activity
In small groups students to brainstorm the various routes of administration of drugs.
It is the path by which a drug, poison or other substance is brought into contact with the body. A substance must be transported from the site of entry to the part of the body where its action is desired to take place. The uptake of drug by the body, its distribution within the body, and elimination from the body (i.e. the pharmacokinetic properties of a drug) are influenced by its route of administration.
Routes of administration can be broadly divided into:
Topical:
The desired effect is local; substance is applied directly where its action is desired
-epicutaneous (application onto the skin), e.g. allergy testing, local anesthesia
-inhalational, e.g. asthma medications
-enema, e.g. dye for X-ray of the intestine
-eye and ear drops, e.g. antibiotics
-intranasal route (into the nose), e.g. decongestant nasal sprays
-vaginal, e.g. topical hormones
Enteral
The desired effect is systemic (non-local); substance is given via the digestive tract
-by mouth, e.g. many drugs as tablets, capsules, or syrup
-by stomach feeding tube, e.g. many drugs and nutrition
-rectally, e.g. various drugs in suppository or enema form
Parenteral
The desired effect is systemic; substance is given by routes other than the digestive tract, e.g.
-Intravenous (into a vein)
-Intramuscular (into a muscle)
Lesson 6: Drug incompatibilities, contraindications, side effects and drug interactions
Occasionally, the drugs used to improve a person’s condition may not work in the manner intended. The outcome may be contrary to that which was expected, and, indeed, could even cause harm to the patient. It is important to be aware of symptoms that may indicate a drug is not doing its job properly. Important information about the medicine and what is known about its side effects can be found in the Consumer Medicine Information (CMI) that comes in the manufacturer’s package.
Drug incompatibility
There are instances when a drug used simultaneously with another drug or substance does not perform as it was intended. These drugs or substances may be incompatible together and, therefore, should not be administered at the same time. A drug incompatibility can also occur when drugs are compounded together in the pharmacy.
Contraindications
A contraindication is any condition the patient might display that makes a particular treatment or procedure inadvisable. E.g. penicillins are contraindicated in people with history of allergy to penicillin.
Side effects
Side effects may occur when a drug, given in an appropriate dose, has an undesirable and/or noxious effect on the patient receiving it. All medicines can possibly cause side effects. While some reactions are dangerous, some are mild and do not last long. Some people react differently to different medicines. Common side effects of aspirin include nausea, vomiting, and stomach bleeding.
Drug interactions
Patients may receive more than one medication at a time. Sometimes the combination of medicines can be harmful. It is important that the patient tells the doctor about every medicine they are taking, including vitamins and minerals.
Activity
In small groups, students to discuss the differences between drug incompatibilities, contraindications, side effects and drug interactions
Medical prescriptions
A medical prescription is an order (often in written form) by a qualified health care professional (doctor) to a pharmacist or other therapist for a treatment to be provided to their patient. A prescription is a legal document which not only instructs in the preparation and provision of the medicine but indicates that the prescriber (doctor) takes responsibility for the clinical care of the patient and the outcomes that may or may not be achieved.
Prescriptions are typically handwritten on preprinted prescription forms that are assembled into pads, or alternatively printed onto similar forms using a computer printer. The doctor writes the name of the patient on the prescription and dates it. The doctor writes the name of the medication and the directions for taking it. Finally there is the doctor's signature. Prescription is commonly written as the symbol "Rx".
Conventions for avoiding confusion
Over the years, many conventions have been developed for prescription-writing, with the goal of avoiding mistakes. These include:
Careful use of decimal points:
Avoiding unnecessary decimal points: a prescription will be written as 5 ml instead of 5.0 ml to avoid possible misinterpretation of 5.0 as 50.
Always using zero prefix decimals: e.g. 0.5 instead of .5 to avoid misinterpretation of .5 as 5.
Avoiding trailing zeros on decimals: e.g. 0.5 instead of .50 to avoid misinterpretation of .50 as 50.
Avoiding decimals altogether by changing the units: 0.5 g is less easily confused when written as 500 mg.
"ml" is used instead of "cc" even though they are technically equivalent
Directions written out in full (although some common abbreviations are listed below).
Quantities given directly or implied by the frequency and duration of the directions.
Where the directions are "as needed", the quantity should always be specified.
Where possible, usage directions should specify times (7 am, 3 pm, 11 pm) rather than simply frequency (3 times a day) and especially relationship to meals for orally consumed medication.
The use of permanent ink.
Avoiding unspecified prn or "as needed" instructions—instead, specific limits and indicators are provided e.g. "every 3 hours prn pain".
For refills, the minimum duration between repeats and number of repeats should be specified.
Providing the indication for all prescriptions even when obvious to the prescriber, so that the pharmacist may identify possible errors.
Avoiding non-standardized units such as "teaspoons" or "tablespoons".
Writing out numbers as words and numerals ("dispense 30 (thirty)").
Lesson 7: List of abbreviations used in medical prescriptions – how to interpret medical prescriptions
Many abbreviations are commonly used in medical prescriptions and are derived from the Latin language. All abbreviations carry an increased risk for confusion and misinterpretation and should be used very carefully.
Table: List of abbreviations used in medical prescriptions
Abbreviation
Meaning
a.c.
Before meals
a.m.
Morning, before noon
amp
Ampoule
amt
Amount
aq
Water
bis
Twice
b.d.
Twice daily
cap., caps.
Capsule
cc
With food, (but also cubic centimeter)
comp.
Compound
cr., crm
Cream
D5W
Dextrose 5% solution (sometimes written as D5W)
D5NS
Dextrose 5% in normal saline (0.9%)
D.A.W.
Dispense as written
dc, D/C, disc
Discontinue
dil.
Dilute
disp.
Dispense
div.
Divide
D.W.
Distilled water
elix.
Elixir
emuls.
Emulsion
fl., fld.
Fluid
g
Gram
gr
Grain
gtt(s)
Drop(s)
H
Hypodermic
ID
Intradermal
IM
intramuscular injections
inj.
Injection
IP
Intraperitoneal
IV
Intravenous
IVP
intravenous push
lin
Liniment
liq
Solution
lot.
Lotion
M.
Mix
mane
Morning
m, min
A minimum
mcg
Microgram
mEq
Milliequivalent
mg
Milligram
mL
Millilitre
nebul
A spray
noct.
At night
non rep.
no repeats
NS
Normal saline (0.9%)
1/2NS
Half normal saline (0.45%)
oz
Ounce
per
By or through
p.m.
Evening or afternoon
p.r.n.
As needed
p.r.
By rectum
pulv.
Powder
q.h.
Every hour
q.i.d.
Four times a day
R
Rectal
rep., rept.
Repeats
RL, R/L
Ringer's lactate
SC, subc, subcut
Subcutaneous
SL
Sublingually, under the tongue
sol
Solution
ss
One half
stat
Immediately
supp
Suppository
susp
Suspension
syr
Syrup
tab
Tablet
tbsp
Tablespoon
troche
Lozenge
tsp
Teaspoon
t.i.d.
Three times a day
t.d.s.
Three times a day
top.
Topical
T.P.N.
total parenteral nutrition
tr, tinc., tinct.
Tincture
ung.
Ointment
vag
Vaginally
X
Times
Y.O.
Years old

Lesson 8: Pharmacy
List of minimum requirements for a pharmacy
The following is a list of the minimum requirements for a Pharmacy as stipulated by the Punjab Drugs Rules, 2007.

I. Entrance: The front of a Pharmacy shall have an inscription “Pharmacy”.
II. Premises: The premises of a Pharmacy shall be separated from rooms for private use. The premises shall be built dry, well lit and ventilated and shall be of sufficient dimensions to allow the goods in stock, especially drugs and poison to be kept in a clearly visible and appropriate manner. The area of the section to be used as dispensing department shall not be less than 6 sq. meters for each person working therein with additional 2 sq. meters for each additional person. The height of the premises shall at least be 2.5 sq. meters.
The floor of the Pharmacy shall be smooth and washable. The walls shall be plastered or tiled or oil-painted so as to maintain smooth, durable and washable surface devoid of holes, cracks and crevices.
A Pharmacy shall be provided with good quality of water.
The dispensing department of the Pharmacy shall be separated from the rest of the Pharmacy by a barrier to prevent the entry of the general public into it.
III. Furniture and apparatus: The furniture and apparatus of the Pharmacy shall be adapted to the uses for which they are intended and correspond to the size and requirement of the establishment.
The drugs and chemicals shall be kept in a room appropriate to their properties and in such special containers as will prevent any deterioration of contents or of contents of containers kept near them. Drawers and other containers used for keeping medicaments shall be of suitable size and capable of being closed tightly to prevent the entry of dust.
Every container shall bear labels of appropriate sizes and be easily readable, with names of medicaments as given in the Pharmacopoeias.
A Pharmacy shall be provided with a dispensing bench, the top of which shall be covered with washable and impervious material like stainless steel, or plastic or be laminated etc.
The containers of concentrated solutions shall bear special labels or marked with the word “Poison” in red letters on a white background.
A Pharmacy shall be provided with the following minimum apparatus and books necessary for making official preparations and prescriptions:
Apparatus
Balances with dispensing sensitivity of 30 mg
Balance counter, capacity 3 kg, sensitivity 1 gm
Beakers lipped of assorted sizes
Bottles - prescription, un-graduated of assorted size
Evaporating dishes – porcelain
Filter papers, funnels, glasses
Glass stirring rods
Litmus papers – blue and red
Measure glasses (cylindrical) –10 ml, 25 ml, 100 ml and 500 ml
Mortar and pestle
Ointment slab – porcelain
Ointment pot with Bakelite (plastic) or other suitable material’s cap
Pill finisher; pill machine; pill box
Pipettes graduated – 2 ml, 5 ml, and 10 ml
Ring stand (retort) iron, complete with rings
Rubber stamps and pad; scissors; spatula
Spirit lamp or gas burner
Thermometers – 0 to 200 °C
Tripod stand
Watch glasses
Water bath
Water distilled for eye drop preparation
Weight metric – 1 to 100 mg
Wire gauze
Suppository mould

Books
The United States Pharmacopoeia (current edition) or British Pharmacopoeia (current edition)
National Formulary of Pakistan (current edition)
The Drugs Act 1976 and rules framed there under
The Pharmacy Act 1967
The Dangerous Drug Act and CNS Act 1997

IV. General provisions: A Pharmacy shall be conducted under the continuous personal supervision of a qualified person referred to in Rule 19 whose name shall be displayed conspicuously in the premises.
The qualified person shall always wear clean white overalls.
The premises and the fittings of the Pharmacy shall be properly kept and maintained and everything must be in good order and clean.
All records and register shall be maintained in accordance with the laws in force.
Any container taken from the poison cupboard shall be replaced therein immediately after use and the cupboard locked. The keys of the poison cupboard shall be kept in the personal custody of the responsible person.
Drugs when supplied shall have labels conforming to the provisions of laws in force.
Note: the above requirements are subject to modification on the directions of the Licensing Authority, if the Licensing Authority is of the opinion that with regards to the nature of drugs dispensed, compounded or prepared by the licensee, it is necessary to relax the above requirements in the circumstances of a particular case.


Storage procedures of drugs (Also see Unit 6 for details on storage) ActivityBrainstorm the storage procedures of drugs. The minimum requirements for the storage and handling of drugs are as follows: (a) FacilitiesAll facilities at which drugs are stored have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions. They are maintained in a clean and orderly condition and are kept free from infestation by insects, rodents, birds, etc. (b) SecurityEntry into areas where drugs are held is limited to authorized personnel. (c) StorageAll prescription drugs are stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of an official compendium, such as the Pakistan Pharmacopoeia / Pakistan National Formulary. If no storage requirements are established for a drug, the drug is held at “controlled” room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected. (d) Returned, damaged, and outdated drugsDrugs that are outdated, damaged, deteriorated, misbranded, or adulterated are quarantined and physically separated from other drugs until they are destroyed or returned to their supplier. Any drugs whose sealed containers have been opened or used are identified as such, and are quarantined and physically separated from other drugs until they are either destroyed or returned to the supplier. (f) RecordkeepingRecords of drugs received are established and maintained. These records include the following information:(i) The identity and quantity of the drugs received; and(ii) The dates of receipt and distribution of the drugs.
Lesson 9: Rational Use of Drugs
Activity
Brainstorm why does the Pakistan National Drug Policy promote the Rational Use of Drugs?
Rational use of drugs requires that patients receive medications appropriate to their clinical needs, in doses that meet their own requirements, for an adequate period of time, and at the lowest cost to them and their community.
In Pakistan and other developing countries there is1:
Overuse of drugs and injection as a consequence of over-prescribing as well over-consumption. It concerns particularly the prescription and use of antibiotics, antidiarrheals, painkillers, injections, and cough and cold preparations.
Multidrug use: the number of drugs per prescription is often more than needed, with an average of 2.4 up to 10 drugs, while generally 1-2 drugs would have sufficed. Multi drug use is also common among people who buy drugs over-the-counter.
Incorrect drug use which involves the prescribing and use of wrong drug for a specific condition (e.g. antibiotics or antidiarrheal for childhood diarrhea), drugs of doubtful efficacy (e.g. antimotility agents for diarrhea), or use of drugs in the wrong dosage (which is often the case with ORS, antibiotics and antimalarials). Incorrect drug use occurs due to incorrect prescribing by doctors and incorrect use by patients. In Pakistan self-medication is a common practice and often results in inappropriate drug use.
The Pakistan National Drug Policy promotes the rational use of drugs with a view to safeguarding public health from over-use, misuse or inappropriate use of drugs. The Government has taken measures to promote rational drug use as follows:
All teaching divisional and district hospitals will monitor and promote rational use of drugs in the hospitals. From the Government platform, a Drug information Bulletin is issued from time to time to provide unbiased information to the medical profession. This shall be published on regular basis and distributed to all doctors, pharmacists and other health professionals. Apart from providing accurate and timely information, the bulletin will endeavor to promote the concept of essential drugs and their rational use. A National Formulary shall be published in a new context so as to serve as reliable prescribing and dispensing guide to all doctors and pharmacists of the country and as an effective teaching aid. Similarly Standard Treatment Guidelines in important areas shall be prepared
Amanda le Grande et al. Health Policy and Planning. 14 (2):89-102; 1999
Lesson 10: Generic, Trade names and Actions of Drugs
Concept of Autonomic Nervous System
Definition
The autonomic nervous system (ANS) (or visceral nervous system) is a network of nerves that regulate involuntary control of cardiac muscle, organ smooth muscle, and glands such that basic biological processes such as digestion and breathing can occur without conscious thought.
Function
The autonomic nervous system maintains internal balance (homeostasis) but also enables humans to respond to changes in the environment. This is achieved because the parasympathetic and sympathetic divisions of the systems are antagonistic. The parasympathetic and sympathetic nervous system usually have opposing effects on target organs. The predominant resting tone of an organ is established by either the sympathetic or parasympathetic system. For example, the predominant resting tone of the eye pupil is constriction, maintained by the parasympathetic nervous system. However, a fearful situation may induce pupil dilation, mediated by the sympathetic nervous system. In other words, the autonomic nervous system enables humans to deviate from normal functions to respond to changes in the environment. The parasympathetic nervous system is often referred to as "rest and digest" and the sympathetic nervous system as "fight or flight."
The ANS affects heart rate, digestion, respiration rate, salivation, perspiration, diameter of the pupils, micturition (urination), and sexual functions. Whereas most of its actions are involuntary, some, such as breathing, work together with the conscious mind. Its main components are its sensory system and motor system (comprised of the parasympathetic nervous system and sympathetic nervous system). The two major subdivisions of the autonomic nervous system, parasympathetic and sympathetic, work jointly to subconsciously control other bodily functions, such as heart rate, blood pressure, digestion, metabolism, reproduction, breathing, excretion, sweating, and temperature. (Also see Sub-unit 2.5 – Nervous System)
Key Terms
· Acetylcholine—a chemical messenger of the nervous system that is also known as a neurotransmitter.
· Nor epinephrine—a chemical messenger of the nervous system that is also known as a neurotransmitter.
· Parasympathetic—the "rest and digest" division of the autonomic nervous system.
· Sympathetic—the "fight or flight" division of the autonomic nervous system.
Neurotransmitters
The primary neurochemical mediator of both sympathetic and parasympathetic preganglionic neurons is acetylcholine (ACh). The primary mediator of sympathetic postganglionic fibers is usually nor epinephrine (NE). The mediator of parasympathetic postganglionic fibers is acetylcholine. Epinephrine is found in the adrenal medulla, the central nervous system and the para-aortic bodies. Dopamine is a neurochemical mediator in the central nervous system and also in some neurons in the superior cervical ganglion and the kidney.
Nor epinephrine, epinephrine and dopamine are sometimes collectively referred to as catecholamines. Nor epinephrine is often called noradrenalin, and epinephrine is also called adrenaline. These endogenous compounds plus drugs that resemble them functionally and structurally are also called sympathomimetic amines.

Autonomic Receptors
· There are multiple types of receptors in the autonomic nervous system. For the sympathetic system the major receptor types are alpha receptors and beta receptors. These are subdivided into alpha-, alpha-2, beta-1 and beta-2.
· The parasympathetic system has nicotinic and muscarinic receptors.
· Adrenergic receptors:
o Usually stimulated by noradrenalin or adrenaline
o Alpha-1 type is found in the smooth muscle of most arterioles and in sphincter muscles of the GI tract and bladder
o Alpha-2 type is found in presynaptic nerves and parts of the GI tract
o Beta-1 type is the dominant type in the heart
o Beta-2 type is found in the bronchioles of the lung, the wall muscles of the bladder and other locations
· Cholinergic receptors:
o Usually stimulated by acetylcholine
o Nicotinic types are found in autonomic ganglia.
o These receptors are different nicotinic receptor found in neuromuscular junctions
o Muscarinic types are found on all organs with parasympathetic nerves
The term "adrenoreceptor" is used for α 1, α 2, β 1, β 2, and β 3-receptors. The D receptors are dopamine receptors and are highly relevant to behavior.
The expressions "adrenoreceptor", "adrenoceptor" and "adrenergic receptor" are synonymous.

Summary
Sympathetic System
· Neurotransmitter Nor-epinephrine
o Receptors Adrenergic (Alpha and Beta)

Parasympathetic
· Neurotransmitter Acetylcholine
o Receptor Cholinergic (Muscarinic and Nicotinic)
ADRENERGIC DRUGS, (Sympathomimetics)
Drugs which have effects which mimic the effects of sympathetic nervous system

Adrenaline
Salbutamol
Terbutaline
Ephedrine
Dopamine
Trade Name
(By generic)…Adrenaline 1: 1000 solution
Ventolin, salbutamol, venex, Aerolin, Asthmol, Bronchotab,
Britanyl, Tebanyl,
By generic. Ephedrine, Ephedra, Unirex-D, Brovinol,
Inj Dopamine, Inj Tropin,
Dosage
For Hypersensitivity Reaction, Bronchial Asthma, Anaphylactic reactions…..Subcutaneous use…..0.5ml
Adult…. 4mg three times daily (oral), 500microgram 4hrly S/C or I/M, 5microgram/Min I/V infusion, 100- 200 microgram by inhalation (1-2 Puffs). 2.5- 5mg By nebulizer 4 times daily
Adult...Oral…2.5 mg three times daily. S/C, I/M, I/V, (under two yrs not recommended), 10 microgram/ kg
Adult… 15–60 mg three times daily. Children 1-5yrs 7.5mg, 8-12yrs 30mg three times daily
I/V infusion 1-20 microgram/kg/min titrate as desire not exceed 54 microgram/ kg/ min. ( Do not use with Sodium Bicarbonate)
Possible routes of administration
Subcutaneous, Intravenous, via endotracheal tube 5 quick insufflations.( if I/V line is inaccessible) Intracardiac ( In cardiac arrest )
-Oral…Tablets, Syrup, - Aerosol ( Inhalers ), -Solution for nebulizer
Oral, S/C, I/M, I/V, Inhalation, Nebulizer
Oral, Topical
I/V infusion
Main clinical usage
Cardiac arrest, Acute Asthmatic attacks, Open angle Glaucoma ( Local use ), Anaphylactic reaction, Nasal congestion, With a local Anesthesia, Shock
Bronchospasm in Bronchial Asthma, And Bronchitis, Prophylaxis in Bronchial asthma and other reversible airway obstruction/ airway spasm, Premature Labor
Bronchial Asthma, Reversible bronchospasm associated with Bronchitis & Emphysema, Premature labor
Nasal congestion, Bronchial Asthma Nocturnal Enuresis Shock
In shock due to Myocardial infarction, Trauma, Septicemia, Renal failure, Respiratory distress syndrome.
Main side effects
Anginal pain, Anxiety, dysrhythmia, hypertension, palpitation, urinary retention, tremor, weakness
Fine tremors of hands, Headache, Nervousness, Tachycardia, Palpitations, Muscle cramps
Anxiety, Dizziness, Headache, Insomnia, Tremor, Shakiness, Nervousness.
Anxiety, Confusion, Dizziness, Tremors, Chest pain, Palpitation, Hypertension, Urinary retention
Headache, chest pain, Tachycardia, Palpitation, Gangrene, Nausea vomiting

ADRENOCEPTOR ANTAGONISTS (SYMPATHOLYTIC DRUGS)

Drugs which inhibit/blocks the effects of sympathetic nervous system

Beta blockers
Non Cardioselective
· Propranalol (inderal, cardioset, beta block)
· Nadolol (corgard )
· Pindolol (viskaldix)

Cardioselective
· Atenolol ( Blokium )
· Metoprolol (lopressor, mepressor, carsel)
· Bisoprolol ( concor )

Alpha blockers
· Prazosin (minipress)
· Doxazosin (cardura, proalpha )
· Terazosin (hytrin)

BETA BLOCKERS
Beta Blockers
Propanalol
Atenolol
Trade Name
Inderal, Beta block, Cardioset, Cardinal
Blokium, Zafnol, Cardiolite, atenolol, normitab, ATN50, Totamol,
Dosage
40mg twice daily or 80mg once daily (oral) max. 240mg
Adult Oral 50-100mg daily in one or two doses
Possible routes of administration
Oral, I/V…1mg.over 1min. IN thyrotoxicosis crisis, & Arrhythmias,
Oral….tabs
Main clinical usage
Angina, Hypertension, Migraine headache (prophylaxis), Ventricular arrhythmias, Hyperthyroidism, Menopausal syndrome, Glaucoma, Anxiety.
Angina pectoris, Performance anxiety, Post myocardial Infarction, Alcohol withdrawal symptoms, esophageal varices with cirrhosis.
Main side effects
Depression, Dizziness, Drowsiness, Fatigue, Memory loss, Lethargy, Strange dreams, Mental changes, Bradycardia, Heart Block, Impotence, Cold extremities,
Depression, Drowsiness, Dry& burning eyes, Lethargy, Cold extremities, Sexual dysfunctions, Alopecia, Pruritis
Contraindications
Bronchial asthma, 2nd &3rd Degree AV block, Bradycardia, CCF
Cardiogenic Shock, 2nd& 3rd Degree heart block., CCF
Antidote in case of poisoning, if any
Atropine
Atropine
ALPHA BLOCKERS

Alpha Blockers

Prazosinn
Doxazosin
Terazosin
Trade Name
Minpress
Cardura, Proalpha
Hytrin
Dosage
0.5mg initially at bed time, increase 1mg two or three times daily. In BPH 500mcg, In CCF start with 500mcg increase 4-20mg gradually
1mg daily initially, may be increased up to 2-4mg daily after weekly intervals
1mg at bed time, may be doubled after 7 days
Possible routes of administration
Oral
Oral
Oral
Main clinical usage
Hypertension, Benign prostatic hypertrophy (BPH), Reynaud’s vasospasm, CCF
Hypertension
Hypertension, BPH
Main side effects
Postural hypotension ( 1st Dose Effect ), Palpitation, Reflex Tachycardia, Chest pain, Tinnitus & Vertigo, Flatulence, anxiety, Paresthesia, Arthralgia & myalgia
Postural hypotension, Headache, Fatigue, Vertigo, Edema
Postural hypotension (1st Dose effect), nausea, blurred vision, nasal congestion, peripheral edema,


CHOLINERGIC DRUGS (PARASYMPATHOMIMETIC Drugs)

Drugs have effects which mimic the effects of parasympathetic system
Acetylcholine
Methachline
Carbchol
Bethenechol
Pilocarpine
Pysostigmine ( antilirium )
Neostigmine ( instgmine )
Pyridostgmine ( mestinon )


Pilocarpine
Neosostigmine
Trade Name
Pilocarpine, Medicarpine, Spersacarpine, Orbacarpine
Instgmine, Neo-choline, Neo-stig., Stigma, Prostigmine
Dosage
1-2 drops frequently as desired
50-70microgram/kg if given I/M injection & If I/V inj. Then 10-15 microgram/kg
Possible routes of administration
Topical……eye drops
I/M & I/V
Main clinical usage
Glaucoma, both closure angle & open angle.
Reversal of non depolarizing neuromuscular blockers, Myasthenia gravis,
Main side effects
Headache, AV block, Blurred vision,
Bronchial secretions, Abdominal discomfort, Urinary incontinence, Muscle cramps, Sweating, hypotension, bradycardia,
Antidote in case of poisoning, if any

Atropine

Treatment of organophosphorus compound poisoning

General Measures

Contaminated clothes should be removed to prevent further absorption
Exposed skin should be washed with soap and water
If orally taken then gastric lavage
Respiratory assistance if required
Maintain vital signs

Pharmacological

Atropine I/V, repeat till pupil is fully dilated
Prolidoxime I/V, if patient is received within 12 hrs of poisoning
MUSCARINIC RECEPTOR BLOCKING DRUGS
Drugs inhibit/block the effects of parasympathetic system at muscarinic receptors
Atropine
Hyoscine (scopolamine)
Ipratropium
Tropicamide

Atropine
Hyoscine ( scopolamine )
Trade Name
Atropine inj., Atrosol inj., Atrovent inj.
Transderm-Scop
Dosage
I/V 0.3- 0.6mg in Premedication, I/V 0.6- 1.2mg in Neostigmine over dosage, I/V 2-3mg in organophsphorus compound poisoning
Transdermal patch for 72 hrs duration of action
Possible routes of administration
I/V injection
Transdermal Patch
Main clinical usage
Preanesthetic medication, Organophosphorus compound poisoning, Sinus bradycardia,
Motion Sickness
Main side effects
Dry mouth, Dry eyes, Dry skin, Blurred vision, fever, Difficulty in micturition, constipation, loss of memory, confusion, postural hypotension, palpitation, ataxia
Preoperative medication, Postoperative medication, Prevention of motion sickness, Inhibit involuntary bladder contractions
Antidote in case of poisoning, if any
Physostigmine


DRUGS USED IN ANGINA

Nitrates
Nitroglycerine
Glyceral nitrate
Isosrbide mononitrate ( Isordil, Isoket, Isotrare )
Isosorbide dinitrate (Ismo20, Monis, Elantan, Flo20)

Beta blockers
Propranalol
Atenolol

Calcium channel blockers
Nifedipine
Diltiazem
Verapamil

Antiplatelet drugs
Aspirin


Nitroglycerine
Calcium Channel Blockers
Antiplatelet Aspirin
Nifedipine
Diltiazem
Verapamil
Trade Name
Glytrin, Angised, Deponint
Adalat, Coracten, Nifidil, Adipen
Cardizem, Herbessar, Angizem, DTZ, Dilzem
Calan, Isoptin, Zavera,
Ascard, Lowprin
Dosage
0.5mg repeat after 3minutes
10-20mg daily
Adult…60-120mg
40-80mg 3-4 times daily(adult)
75-150mg daily
Possible routes of administration
Sublingual, transdermal
Oral, Sublingual
Oral
Oral
Oral
Main clinical usage
Angina pectoris, Perioperative hypertension,
Angina, Hypertension. Prevention of migraine, Cardiomyopathy,
Angina, Hypertension, Raynaud’s Syndrome. Dysrhythmias
Angina, Dysrhythmia,
Prophylaxis of margarine, Cardiomyopathy
Angina, Post MI,
Main side effects
Headache, Anxiety, Postural hypotension, Dysurea, Tachycardia
Hypotension, Palpitation, Hair loss, Epistaxis, Peripheral edema, Flushing, Gastric upset,
Abdominal cramps, Depression, Headache, Hallucinations, Insomnia, Parasthesia, Personality change
Headache, Asthenia, Dizziness, Hypotension, Nocturia, Polyuria
Bradycardia, edema, CHF
Hypersensitivity, GIT bleeding, Gastritis

DIURETICS


Furosemide
Spironolactone
Acetazolamide
Hydrochlorthiazide
Trade Name
Lasix, Frusid, Frusemide, Uremide, Aquasan,
Aldactone
Diamox, AZM, Evamox,
Moduretic, Dyazide,
Dosage
Adult….20-40-80mg daily
Adult …25-200mg
Adult 250-1000mg daily
Adult 25-100mg
Possible routes of administration
Oral, I/V
Oral
Oral
Oral
Main clinical usage
Edema (CHF, Hepatic cirrhosis, Nephrotic syndrome
Pulmonary edema (MI)
Hypertension, Edema, CHF, Nephrotic synd. Polycystic ovary disease, Premenstrual synd. Female hirsutism

Open angle glaucoma, Narrow angle glaucoma, epilepsy, CHF, Acute mountain sickness, edema
Edema, Hypertension. Hypercalciurea, Diabetes inspidus
Main side effects
Hyperglycemia, Hyperurecemia, Potassium loss
Headache, circulatory collapse, Aplastic anemia, Leucopenia
Pruritis, Confusion, Drowsiness, CHF, Hypotension, Cramps, Amenorrhea, Postmenopausal bleeding
Anxiety, confusion, Fatigue, Constipation, uremia, Aplastic anaemia, Crystalurea, myopia, Tinnitus, Hyperglycemia, Photosensitivity
Hypokalemia, Fatigue, Photosensitivity, Hyperuricemia, Paresthesia

DRUGS USED IN HYPERTENSION

Diuretics
Furosemide
Hydrochlorthiazide
Spironolactone
Acetazolamide

Beta blockers
Propranalol
Atenolol

Calcium channel Blockers
Amlodipine
Nifidepine
Diltiazem
Verapamil

Angiotensin Converting Enzyme Inhibitors (ACE inhibitors)
Captopril
Lisinopril
Enalapril

Angitensin receptor blockers
Losartan potassium


ACE Inhibitors
Angiotensin receptor blocker

Captopril
Lisinopril
Enalapril


Trade Name
Capoten, capace, capril, quitril, captil
Zestril, Lisopril, Novatec, Lame
Renitec, zepres, enpril, cardioteccortec, enace
Losar K, Ezi-day, cozar, Tansin, Xavor

Dosage
Adult 6.25-12.5mg
Adult 2.5-5.0-10mg daily
Adult 2.5-5mg
Adult 50-100mg/ day

Possible routes of administration
Oral
Oral
Oral
Oral

Main clinical usage
Hypertension, CHF, Retinopathy with diabetes, MI,
Hypertension, CHF, MI, Retinopathy, nephropathy
Hypertension, CHF, MI,
Hypertension. CHF, MI, Diabetic nephropathy,

Main side effects
Chills, Fever, chest pain, loss of taste, Bronchospasm, acute reversible renal failure, neutropenia, agranulocytosis.
Angioedema, constipation, dry cough, myalgia, palpitation, postural hypotension, headache, insomnia, decreased libido
Agranulocytosis, neutropenia, headache, fatigue, decreased libido, constipation, abdominal pain, dry cough, asthma sinusitis
Back pain, nasal congestion, elevated liver enzymes, muscle cramps, myalgia


ANALGESICS
Analgesic may be defined as the medicine which relieves pain without causing loss of consciousness.

Analgesics may be classified as:

Opioids: which are obtained from opium
Morphine, Pentazocine, Mepredine

Non opioids: NSAIDS…Non Steroidal Anti-Inflammatory Drugs

Opioids


NSAIDs
Aspirin
Acetaminophen
Diclofenac sodium.
Naproxen
Ibuprofen
Indomethacin
Trade Name
Morphine
Pentazocine
Mepredine
Disprin, ascard. lowprin
Calpol, Panadol. Disprol, febrol
Voltaren, Dicloran, denum, voren, arnil
Synflex, naprox, napgesic, flexin, xenar
Brufen, Dolofen, dorafen, hifen, ifen, kayfen
Indocid, incin, methacid, indobid, anglocid, camocid
Dosage
5-10mg i/v
Sosegon
Vesegen
Pentazogon, Pntonil, 25-100mg(oral), 30-60mg by inj.
Pethedine, Demerol
75-150mg as antiplatelet. & 300-600mg as analgesic and antipyretic.
Adult 500-1000mg thrice or four time a day
50-150mg/day
500-1000mg in two divided doses
400mg, thrice daily after meal
25-50mg two times a day soon after meal
Possible routes of administration
I/V, Oral, Epidural.
Oral, I/M, I/V
I/M, I/V
Oral
Oral
Oral. I/M inj.
Oral
Oral
Oral
Main clinical usage
MI, Pulmonary edema, Preop sedation, Adjuvant with anesthesia, acute cholycystitis with spasmolytic.
Moderate pain,
Moderate to severe pain, head injury, after labor pains, bone fracture, acute cholycystitis
Antipyretic. Arthritis, mild to moderate pain
Antipyretic, mild pain, headache, backache, migraine
Mild to moderate pain, joint pains, billary colic, renal colic, dysmenorrhea, backache, sciatica
Mild to moderate pain. Arthritis, ankylosing spondilitis
Mild to moderate pain, joint pain, fever, tenosinovitis. Sciatica, gout, rh. Arthritis, ankylosing spondylitis
Apnea of prematurity, colon cancer prevention, gout, rheumatic arthritis, patent ductus arterosis to delay surgery
Main side effects
Respiratory depressions, constipation, increase billary tract pressure.
Agitation, dependency, circulatory depression, increased B.P., Respiratory depression, leucopenia
Dependency, respiratory depression.
GIT bleeding, gastritis, peptic ulcer, hypersensitivity.
Gastritis, peptic ulcer, Acute hepatic and renal failure, delirium vascular collapse
Same as other NSAIDs,
Same as other NSAIDs
Same as other NSAIDs, Hypersensitivity
Intestinal perforation, peptic ulcer, gastritis, GIT bleeding
Antidote in case of poisoning, if any
Naloxon, i/v, repeat every 30-45 mins.
Nalaxon
Nalaxon.

Acetylcysteine





Mefanamic Acid
Trade name: Ponston, mafacid, jastan
Dose: 500mg thrice daily after meal
Route: Oral
Uses: mild to moderate pain
Side effect: as other NSAIDs


DRUGS USED IN GOUT
Gout is a disease in which there is increase in serum uric acid, which is deposited in tissues especially in joints and tissues around the joints. This causes inflammation. There is severe pain. For pain relief NSAIDs are used. BUT ASPIRIN IS NOT USED because at causes increase in uric acid.
Other drugs which are used decrease serum uric acid e.g. allopurinol & cholchcine
If inflammation is severe then use of steroids for short term may be considered



Allopurinol
Cholchicine
Trade Name
Zyloric, progout, zynol, zyrin
colchicine
Dosage
100-300 mg single or two divided doses
0.5 mg initially two tabs then one every2-3 hrs.
Possible routes of administration
Oral
Oral
Main clinical usage
Chronic primary or secondary gout, Tophi gout, hyperurecemia,
Gout.
Main side effects
Anorexia cholestatic jaundice, epistaxis, cataract, stomatitis, peptic ulcer
Alopecia, peripheral neuritis, agranulocytosis, dermatitis, aplastic anemia, metallic taste, reversible azospermia

DRUGS USED IN CCF
Congestive cardiac failure (CCF), in this condition heart is unable to pump the blood sufficiently according to the need of the body. In this condition mainly left ventricle is involved but right ventricle involvement worsens the condition by pulmonary congestion and liver engorgement. That is the reason to call the situation as CCF. Drugs which are used for the treatment includes
Diuretics (already described)
Cardiac glycosides
ACE Inhibitors (already described)



Digoxin
Captopril
Trade Name
Lanoxin
Capoten, capril, quitril
Dosage
0.25-1.5mg
6.25-12.5mg daily
Possible routes of administration
Oral, I/M, I/V
Oral
Main clinical usage
CCF
CCF, CHF, MI, Hypertension, Nephropathy,
Main side effects
Dysrhythmias, AV block, seizures, atrial fibrillation, hallucination, hemorrhage necrosis of intestine, thrombocytopenia
Chills, fever, chest pain, tachycardia, bronchospasm, neutropenia, postural hypotension, acute reversible renal failure, hypokalemia
Antidote in case of poisoning, if any
Digibin (antibodies)


ANESTHETICS
General Anesthetics
Inhalant Anesthetics
Halothane
Nitrous oxide
Intravenous Anesthetics
Pentothal
Ketamine

Local Anesthetics
Lignocaine


General Anesthetics
Local Anesthetics

Inhalants
Intravenous


Halothane
Nitrous Oxide
Thiopental
Ketamine
Lidocaine
Trade Name
Halothane
Nitrous oxide
Pentothal sodium, Thiopen, Thiotal,
Kite, ketlar, ketsol, kanox, calypsol
Lignocaine, Xylocaine, Elkocaine
Dosage
Induction 5% then maintenance 0.5% -2% mixture
66% mixture with 23% oxygen
3-5mg/kg
6.5-13.0mg/kg

Possible routes of administration
Inhalation
Inhalation
I/V
I/V
LOCAL at required site by injection or topical
Main clinical usage
G/A
G/A
G/A, Induction
G/A, Induction, anesthesia is also called Dissociative anesthesia
Local anesthesia
Main side effects
Hepatotoxicity. halothane hepatitis, fall in B.P. malignant hyperthermia, shivering

Hypotension, Respiratory depression, laryngeal spasm, broncospasm, post-op. Vertigo, apnea
Vivid dreams, hallucinations, clonic tonic movements, hypotension, tachycardia, respiratory depression
Apprehension, heart block, cardiovascular collapse, Respiratory depression & arrest, malignant hyperthermia
Antidote in case of poisoning, if any







ANALEPTICS

Nikethemide
Doxapram
Trade Name
Nikorin, Coramine
Doparam
Dosage
0.5-1.0mg/kg
0.5-1mg/kg…do not exceed 1.5mg kg
Possible routes of administration
Oral. I/V
I/V
Main clinical usage
Post operation respiratory depression, COPD resp. depression
Respiratory depression in just born baby during resuscitation, postop. Respiratory depression, apnea of prematurity
Main side effects
convulsions




SEDATIVE & HYPNOTIC DRUGS
Sedative: medicine which allays excitement
Hypnotic: a medicine which induce sleep


Barbiturates
Non barbiturates

Benzodiazepines

Phenobarbitone
Chloralhydrate
Triclofos sodium
Diazepam
Alprazolam
Midazolam
Chlordiazoxide

Trade Name
`Fenton, Phenobarb, Phenotab
Apnotek, Chloral hydrate, Somnite
Tricloryl
Valium, neopam, diazepam, velipam
Xanax
Dormicum, Domi, Hypozam, Noctrum
Chlobrium, Librium, Elinium,

Dosage
30-210mg daily in divided doses,

0.5-1g (Max 2g). with plenty of water
25-35mg/kg, 1-2g for adult at bed time
2-10mg tid, qid
0.25-0.5-1mg
1-2mg
5-10mg/t.i.d. anxiety
20-25mg for sedation. 50-100mg for alcohol withdrawal

Possible routes of administration
Oral, I/V,
Oral
Oral
Oral, I/M, I/V
Oral
Oral, I/V, I/M
Oral

Main clinical usage
Insomnia, Eclampsia, Epilepsy, Febrile convulsions
Sedation, preop. Sedation, alcohol withdrawal
Short term management of insomnia
Anxiety, insomnia, muscle relaxant, convulsion, eclampsia
Anxiety, panic disorders, premenstrual synd, phobias, sleep inducer
Pre-op sedation I/M, G/A Induction I/V, Insomnia
Anxiety, sedation, insomnia, tremors, tension headache, panic disorders

Main side effects
Drowsiness, sedation, confusion, megaloblastic anemia, Ataxia Dizziness, Respiratory depression
Flatulence, headache, nightmares, gastric irritation. leucopenia
Skin rash, headache, nausea
Respiratory depression. Drowsiness, venous thrombosis, fatigue, withdrawal synd.
Bradycardia, tinnitus, fatigue, dry mouth, hallucinations, drowsiness
Respiratory depression, laryngospasm, bronchospasm, blocked ears, paresthesia, euphoria, amnesia
Fatigue, drowsiness, hallucinations, change in libido, hypotension, slurred speech, confusion

Antidote in case of poisoning, if any
Nikethemide if required for resp. depression


Flumazenil
Flumazenil
Flumazenil
Flumazenil


ANTIHISTAMINES

Chlorheniramine
Pheniramine maleate
Promethazine
Cetirazine
Trade Name
Piriton
Avil, , Allervil, javil, uwill
Phenergan, Methagan, promethazine, semozin
Zyrtec, histex, cetrin, avec
Dosage
4mg, 3-4 times a day
25mg 3-4 times a day orally. By injection dose depends upon severity of reaction, ½ - 1 ampoule 22.7mg/ml containing 2ml
Adult 25-50mg, children 5-15mg in divided doses
10mg/once a day
Possible routes of administration
Oral
Oral, I/M, I/V
Oral, I/M, I/V
Oral
Main clinical usage
Allergic reactions
Seasonal rhinnits
Allergic reactions, seasonal rhinitis, Attacks of sneezing, running nose, urticaria, pruritis, reddening and swelling of skin
Systemic relief of allergies hay fever, urticaria, emergency treatment of allergic reaction. Nausea, vomiting vertigo motion sickness
Allergic reactions, seasonal allergic rhinitis, chronic urticaria, allergic conjunctivitis,
Main side effects
Hemolytic anemia, thrombocytopenia, agranulocytosis, dizziness, drowsiness, dry mouth, chest tightness
Hemolytic anemia, thrombocytopenia, agranulocytosis, Dizziness, Drowsiness, dry mouth, chest tightness,
Drowsiness, headache, psychomotor impairment, urinary retention, blurred vision
Drowsiness, headache, Dizziness, dry mouth, agitation, GI upset


CORTICOSREROIDS
Corticosteroids are hormones which are formed in adrenal cortex. These hormones are released in the blood and act on their target tissues. In this way these have physiological role. These are classified as Glucocorticoids (affect energy metabolism especially carbohydrates) and minralocorticoids (affect the water and electrolytes). Most of the steroids which are in clinical use are synthetic or semi synthetic. Naturally occurring glucocorticoid is cortisol, also called hydrocortisone. And naturally occurring minrelocorticoid is aldosteron. Synthetic steroids include dexamethasone, prednisolone, betamethasone, triamacinolone, clobestol, beclomethasone and others.


Dexamethasone
Prednisolone
Beclomethasone
Triamacinolone
Cortisone acetate
Trade Name
Decaderon, irzamethasone, dexadron, phesone
Deltacortil, prednislon
Beclomin, Becotide, beclofort
Kenacort, tricort, lunacort, azmacort
Solu-cortef, hyzonate, cortisol
Dosage
0.75-9mg as needed
10-20mg daily
200mcg twice or 100mcg thrice daily
8-32mg in four divided doses
100-500mg i/v according to the situation
Possible routes of administration
Oral, I/M, I/V, topical
Oral, I/M, topical
Inhalation
Oral, I/M, intra-articular, intra-synovial injections, inhalation
I/V
Main clinical usage
Anaphlactoid reaction, urticaria, eczema, pruritis, allergic reaction, sneezing, seasonal rhinitis
Anti-inflammatory, immunosuppressive

Chronic asthma, seasonal rhinitis, recurrent nasal polyps
Anti-inflammatory, psoriasis, eczema, allergic reactions, osteoarthritis
Anaphylactic reaction, status asthmaticus, shock, medical emergencies inflammatory bowel disease
Main side effects
Pancreatitis, seizures, fluid retention, hyperglycemia, cataract, hypertension, gastritis, GI hemorrhage, Cushing Synd.
Same as dexamethasone
Headache, dry mouth. Candidiasis in mouth, nasal ulceration, perforation of nasal septum, paresthesia
Same as other steroids
Pancreatitis, seizure, GI bleeding, cataract, osteoporosis, increased intraocular pressure, thrombo-embolism, secondary infections, fragile skin



DRUGS USED IN GIT

Drugs used to treat peptic ulcer
Peptic ulcer is actually disease of stomach. In this condition there is increase production of HCl in gastric secretions or decreased resistance of lining mucosa. In both situations pepsin a digestive enzyme in gastric secretions, get access to the stomach wall and causes small wound. That is called ulcer. As pepsin is involved and site is stomach, it is called peptic ulcer.

While treating ulcer drugs used, either decrease the production/synthesis of HCl (Proton pump inhibitors, H2 receptor blockers) or increase resistance of mucosa. This increase in resistance is achieved by using the drugs which increase production of mucus in the stomach. Some drugs form coating over the surface of ulcer (sucralfate, bismuth carbonate).

Antacids are the drugs which neutralize the acid present in the stomach. They only provide symptomatic relief and are used as adjuvant with other drugs.


Antacids
H2 Receptor Blocks
Proton Pump Inhibitors


Sodiumbicarbonate (Carminative)
Ca, Mg salts
Cimetidine
Ranitidine
Nizatidine
Famotidine
Omeprazole
Lansprazole
Sucralfate
Trade Name
Carminative
Magnesium sulphate, magnesium trisilicate, alumenium sulphate, alumenium trisilicate, calcium carbonate, aabismith carbonate, sodiumbicarbonate.
Tegamet, Acidil
Zantac
Ulcid, Axid
Famocid, ulsamark, zepsin, fomin
Inhibital. Omega, Losec,omex,
Lansor, lanzit, zoton, lanzol
Ulsanic, ulcerate
Dosage
30ml mixture after every meal
Different preparations in combinations sos use
400mg BID
150mg bid
150-300mg
40mg at night.
20-120mg daily, according to the condition if 80mg or more than two divided doses,
15-30mg daily

2g. twice daily
Possible routes of administration
Oral
Oral
Oral, I/V
Oral, I/V
Oral, I/V
Oral
Oral
Oral
Oral
Main clinical usage
Dyspepsia, indigestion, gastro-esophageal reflux
As carminative
Peptic ulcer, acid peptic disease,
Peptic ulcer, acid peptic disease.
Same as cimetidine
Peptic ulcer, acid peptic disease, gastro esophageal reflux
Peptic ulcer, reflux esophagitis, zollinger Ellison syndrome
Same as omeprazole
Peptic ulcer, reflux esophagitis, prevention of stress ulcers
Main side effects
Eructation, perforation of peptic ulcer, flatulence, rebound increase in HCl synthesis, systemic alkalosis
Flatulence, constipation, diarrhea, systemic alkalosis with liberal use
Alopecia, oligospermia, galactorrhea, gynecomastia, impotence, aplastic anemia.
Alopecia, av block, arthralgia, leucopenia, myalgia

Thrombocytopenia, dizziness, palpitation, constipation, acne, urticaria
Seizure, bronchospasm, abnormal liver enzymes, thrombocytopenia
Aesthesia, dizziness, headache, flatulence, back pain, achlorhydria,
Headache, abdominal pain, increased ALT, AST, Nausea
Laryngo-spasm, renal failure, headache, constipation, vertigo

ANTIEMETICS
Drugs which prevent vomiting


Metoclopramide
Prochlorperazine
Dimenhydrinate
Promethazine
Trade Name
Maxolon, metoclop, clopan, plasil
Srematil, stabil, procotil
Gravinate, dymin, devom
avomin
Dosage
10mg tid in adults, should be avoided in children and elderly.
5mg tid,
50-100mg 6 hrly not exceed 400mg/day
25mg tid for vomiting. For motion sickness 25mg 2hrs before journey
Possible routes of administration
Oral, I/M, I/V
Oral, injectable
Oral, i/m, i/v, neonates should be avoided
Oral
Main clinical usage
Nausea, vomiting, with cancer chemotherapy, with peptic ulcer drugs, with migraine drugs
Severe nausea vomiting in different conditions
Nausea, vomiting, motion sickness, menier’s disease
Nausea, vomiting, Motion sickness
Main side effects
Seizures, convulsions, urinary frequency, galactorrhea, gynecomastia
Neuroleptic malignant synd, aplastic anemia, rash, dizziness, drowsiness, agranulocytosis, hyperprolactinemia, breast engorgement, increased depth of respiration,
Dry mouth, hemolytic anemia, lassitude,
Anxiety, confusion, dizziness, fatigue, agranulocytosis, hemolytic anemia, cholestatic jaundice, dysurea

PURGATIVES
Drugs which increase peristalsis of intestine and evacuate bowel.
These drugs are classified as
Cathartics
Saline laxatives
Milk of magnesia
Magnesium citrate
Magnesium sulphate
Sodium phosphate
Sodium sulfate
Castor oil
Bisacodyl
Non absorbable hyperosmolar solution
These drugs are used to evacuate the bowel for preparation of patient for abdominal surgery; effect comes after 2-6-12 hrs. Some times before labor it is required to evacuate the bowl, in such situation soap enema is used to evacuate rectum so that delivery field remain clean and hygienic.

Bulk forming laxative
Isapghula husk
High fiber diet
Carboxy methyl cellulose
These drugs are used to relieve constipation. With these drugs patient is advised to take plenty of water. Effect comes in 1-3 days
Osmotic laxatives
Lactulose syrup ( Levolac )
Fecal softeners
Liquid paraffin,
Bland vegetable oils
Dioctyl sodium succinate
Such drugs are given to the patients suffering from piles( hemorrhoids) to avoid constipation and easy passing of stools.

ANTIDIARRHOEAL
These drugs are used in decrease the frequency of stools in non specific and non infective diarrhea. If there is blood or mucus in stools or patient has fever then these drugs are not given. In such situation proper antibiotic or if there is amoebic dysentery antiamoebic drugs like metronidazole (flagyl) are used. In case of cholera doxycycline ( vibramycin )is used along with fluid and electrolyte replacement.
In children especially neonates and below one year, antidiarrheal drugs are not used. Only treatment is replacement of fluid and electrolyte replacement is done. For this dehydration is accessed. If mild dehydration is there then oral rehydration salt ( ORS ) is used.
In moderate to severe dehydration i/v replacement of fluid is done accordingly

Commonly used antidiarrheal drugs are as follows


Diphenoxylate
Lopramide
Kaolin-pectin
Attapulgite
Trade Name
Lomotil , motilex, rexotil dipotil
Imodium, hoff, diastop, lomide, lopra, loperam
Diarhol, Kaoplex, furazole, kaltin
Entox-p, kaopulgite, semotox-t
Dosage
Under 4 yrs not recommended. In adults 4 tabs initially, then 2 tabs after every stool. In 13-16 yrs 2 tabs
4mg initially, then 2mg after every stool max 16 mg daily
Adult 4-8 tsf after every stool. In children 6-12 yrs 2tsf, below 2 1tsf
500-100mg initially then 500 mg after every stool
Possible routes of administration
Oral
Oral
Oral
Oral
Main clinical usage
Non specific non infective & chronic diarrhea
Non specific non infective diarrhea, chronic diarrhea like inflammatory bowel syndrome,
Non specific non infective diarrhea
Non specific non infective diarrhea, traveler diarrhea
Main side effects
Fatigue toxic megacolon, dry mouth, dizziness, drowsiness
Toxic megacolon, constipation, respiratory depression, dry mouth, abdominal pain
constipation
constipation
Antidote in case of poisoning, if any
Nalaxon
Nalxon




DRUGS USED IN RESPIRATORY SYSTEM

The most important symptom of respiratory diseases is cough. It may be defined as forceful expulsion of air from the lungs to clean it from secretions or foreign body. It is a protective reflex, i.e. it protects air passages.
Cough is important symptom of bronchial asthma, pulmonary tuberculosis, whooping cough. In such situations treatment is given according to the disease i.e. in asthma bronchodilators, and in pulmonary tuberculosis anti T.B. drugs. When there are increased secretions, antitussive drugs should not be given as it cusses complications.

ANTITUSSIVE DRUGS.

Drugs which inhibit cough are called antitussives.

Antitussive drugs are given when cough is troublesome and patient sleep is disturbed, dry cough as in smokers. Antitussives are classified as

Centrally Acting Drugs

These drugs act on CNS
Narcotics
Pholcodeine
Codeine
Dihydrocodeine
Opium tincture
Dihydromorphine
Non narcotics
Dextromethorphan
Noscapine
Levopropoxyphene

Peripherally acting drugs

Steam inhalation
Glycyrrhiza
Dropropizine
Glycerin

EXPECTORANTS

Direct acting
Potassium iodide
Iodine iodide

Reflexly acting
Ammonium chloride
Ammonium carbonate
Ipecacuana

In the market different combinations of antitussive and expectorants with bronchodilator and antihistamine are available.
Such as Corex-d - contains chlorpheniramine, ephedrine, sodium citrate,
Hydraline - contains aminophline, diphenhydramine, ammonium chloride
Bronchdyl-d - contains chlorpheniramine, ammonium chloride, ephedrine, dexamethasone

DRUGS USED IN ASTHMA

BRONCHODILATORS
Sympathomimetic drugs
Salbutamol
Terbutaline
Ephedrine
Adrenaline
Xanthine derivatives
Aminophyline
Theophyline
Etaphyline
Parasympathetic drugs
Ipratropium

CORTICOSTEROIDS
Beclomethasone
Dexamethasone
Hydrocortisone
MAST CELLSTABLIZERS
Sodium chromoglycate
Ketotife
In acute asthmatic attack oxygen inhalation is also given



ANTI-TUBERCULOUS DRUGS
First line treatment
Ethambutal
Isoniazid
Rifampicin
Pyrazinamide
6 month regimen
Rifampicin, INH, pyrazinamide
9 month regimen
INH, rifampicin

DRUGS USED IN DIBETES MELLITUS
By injection
Insulin
Insulin regular
Insulin NPH
Insulin lente
Oral
Sulphonyl ureas
Glibenclamide (daonil, diabeta, diamide)
Gliclazide (diamicron, azide, diclazide)
Chlorpropamide ( diabinese )
Glimepride ( amaryl )
Glipizide (minidiab, glizide, glipase, glibenese )
Bigunides

Metformin, ( glucophage )

ANTIBIOTICS

These drugs are used to treat infections i.e. to kill bacteria of different types
Major groups of antibiotics are
Penicillins
Benzyl penicillin
Procaine penicillin
Penicillin V
Ampicillin (penbritin)
Amoxicillin (amoxil, jaxil)
Cephalosporins
Cephradine ( velosef, valodin )
Cephalaxin ( ceporex, keflex)
Cephazolin ( kefzol)
Cefachlor( ceclor )
Cefotoxime( claforan )
Ceftriaxone (Rocephin)
Tetracycline
Oxytetracycline (teramycin)
Doxycycline (vibramycin, doxy. Vibrex)
Minocycline ( minocin )
Demeclocycline

Aminoglycosides
Streptomycin (injectable)
Gentamicin ( inj. Cidomycin, inj. Refabacin, inj. rigaminol)
Kanamicin ( kanacillin, kanacyn, kantrex)
Neomycin ( topical use…cicatrin powder, betacin)
Tobramycin ( topical use….tobrex, eye drops, ointment)
Amikacin Oral, injectable, amikacin (i/m, i/v)

Macrolides
Clarithromycin
Azithromicin


Categories of drugs
Drugs may be divided into two categories:
A) Prescription Drugs: These drugs are used under medical supervision because these are considered to be unsafe. So they are dispensed only by an order of registered doctor. e.g. antibiotics, drugs for anxiety, antidepressant etc.
B) Non-Prescription Drugs: These drugs are considered relatively safe and can be sold without physician's prescription over the counter (OTC) e.g. vitamins, antacids, paracetamol etc.
Note: In Pakistan and other developing countries, almost all drugs are available as non-prescription drugs. However, in the developed countries such as the United Kingdom, United States of America, Australia etc, prescription drugs are strictly dispensed only by an order of registered doctor.
Class room evaluation

Student: _________________________ ID: __________________________

Teacher: _________________________ Unit 3: Pharmacology

Date: ________________________


Pharmacology is the study of the _________ of the _______ in the body.


Define chemotherapy.
________________________________________________________________________________________________________________________________________________________________________________________________________________________

Epicutaneous, inhalational, eye and ear drops and enema are examples of the following route of administration: (circle the correct answer)

a. Enteral
b. Parenteral
c. Topical


What are the four main sources of drugs?
a. ______________
b. ______________
c. ______________
d. ______________

Every drug has the following three names:
a. ______________
b. ______________
c. ______________


Give some examples of the different forms and preparations of medicines.
a. ______________
b. ______________
c. ______________
d. ______________
e. ______________
f. ______________
g. ______________

Following are some abbreviations commonly used in prescriptions. What do they mean?
b.i.d._____________________________
noct._____________________________
Prn______________________________
q.i.d._____________________________
t.d.s._____________________________

Explain how the premises of a Pharmacy should be like as stipulated by the Punjab Drugs Rules, 2007.
________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
What is the major difference between a general anesthetic and a local anesthetic?
________________________________________________________________________________________________________________________________________________

What are the Neuromuscular Blocking Agents used for?
________________________________________________________________________________________________________________________________________________

Analgesics are used to relieve (choose one)
a. Fever
b. Pain
c. Inflammation

Opioid analgesics have ____________ action in the body and are mainly used for _________ relief.

Give any three examples of Non Steroidal Anti-inflammatory Agents.
a. ____________________
b. ____________________
c. ____________________

Define anemia.
________________________________________________________________________________________________________________________________________________

What are the two main uses of Acetylsalicylic acid?
________________________________________________________________________________________________________________________________________________

What are diuretics? Give three examples.
________________________________________________________________________________________________________________________________________________

Give three examples of antacids.
a. ________________________
b. ________________________
c. ________________________

What are the 4 drugs used to treat diabetes?
a. ________________________
b. ________________________
c. ________________________
d. ________________________

A ___________causes the pupil to contract. A ________ causes the pupil to dilate.


What are the 2 drugs used to treat depression?
a. ________________________
b. ________________________
c. ________________________
d. ________________________

Aminophylline, salbutamol and theophylline are used to treat ___________________.

Lactated Ringer's solution is used for ________________________________________________________________________________________________________________________________________________

What is the difference between antiseptics and disinfectants?
________________________________________________________________________________________________________________________________________________


Annex 1
THE DRUGS ACT
(XXXI OF 1976)
[llth May, 1976]
An Act to regulate the import, export, manufacture, storage, distribution and sale of drugs
Preamble : Whereas it is expedient to regulate the import, export, manufacture, storage, distribution and sale of drugs:
It is hereby enacted as follows:--
CHAPTER I
Introductory
1. Short title, extent and commencement: (1) This Act may be called the Drugs Act, 1976.
(2) It extends to the whole of Pakistan.
(3) It shall come into force at once.
2. Application of other laws not barred: The provisions of this Act, shall be in addition to, and not in derogation of, the Dangerous Drugs Act, 1930 (11 of 1930), and any other law for the time being in force.
3. Definitions: 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 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;
(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, homoeopathic or biochemic system of treatment except those substances and in accordance withsuch conditions as may be prescribed;
(ii) abortive and contraceptive substances, agents and devices, surgical ligatures, sutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive plasters, gelatin 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 disinfection 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;
"Labeling" 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, finishing and labeling 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 labeled in the prescribed manner; or
(ii) on the label or labeling of which any word, statement or other matter or information required by the rules to appear on the label or labeling is not prominently placed with such conspicuousness (as compared with other words, statements, designs, or devices on the label or labeling) 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 labeled 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 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;
(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.
CHAPTER II
Administration and Enforcement
4. Regulation and prohibition of import, etc., of drugs: (1) The Federal Government shall regulate the import and export. of drugs in the prescribed manner and for that purpose may make such orders and issue such directions to the importers and exporters as it may deem fit.
(2) If in the opinion of the Federal Government the public interest so requires, the Federal Government may, by notification in the official Gazette,--
(a) direct that a drug or a class of drugs specified in the notification, or drugs generally, shall not be imported or exported otherwise than under the authority of 'a license issued under this Act or except by an importer or exporter or through an indentor registered in accordance with the rules;
(b) direct that a drug or class of drugs specified in the notification shall not be imported except by an agency of Government so specified; or
(c) prohibit the import or export of any drug or class of drugs specified in the notification.
[(3) Subject to sub-sections (1) & (2), only such drugs shall be imported which are on sale in the market of any of the Western European countries, USA, Japan, Australia or any other country as may be prescribed.]
5. Regulation of manufacture of drugs: (1) The grant of licenses to manufacture drugs shall be regulated in accordance with such conditions and procedure as may be prescribed, by a Central Licensing Board to be set up by the Federal Government and consisting of such representatives of the Federal Government and the Provincial Governments as may be prescribed.
(2) The members of the Central Licensing Board shall exercise such powers, including the powers of an Inspector, as may be prescribed.
(3) The Central Licensing Board shall, [with the approval of the Federal Government and by notification in the official gazette,] make regulations to regulate the conduct of its business.
(4) Any member of the Central Licensing Board may, at any time, by writing under his hand addressed to the Federal Government, resign his office or shall vacate his office if the Federal Government, being of opinion that in the public interest it is necessary so to do, so directs.
(5) Subject to sub-section (4), a member of the Central Licensing Board shall hold office for the prescribed period.
6. Regulation of sale of drugs : The Provincial Governments shall regulate the sale of drugs in the prescribed manner and may for that purpose make such orders, and issue such directions to the importers, manufacturers, stockists, retailers or other dealers of drugs, as they may deem fit.
7. Registration of drugs : (1) The Federal Government shall cause all drugs to be registered in-accordance with such conditions and procedure as may be prescribed and for that purpose set up a Registration Board, consisting of such number of persons, possessing such qualifications, as may be prescribed.
Explanation: In this section, "drugs" means drugs which are in the finished form ready for use.
(2) The members of the Registration Board shall exercise such powers, including the powers of an Inspector, as may be prescribed.
(3) The Registration Board shall, [with the approval of the Federal Government and by notification in the official gazette,] make regulations to regulate the conduct of its business.
(4) Any member of the Registration Board may, at any time, by writing under his hand addressed to the Federal Government, resign .his office or shall vacate his office if the Federal Government, being of opinion that in the public interest it is necessary so to do, so directs.
(5) Subject to sub-section (4), the members of the Registration Board shall hold office for the prescribed period.
(6) The Federal Government shall, by notification in the official Gazette, fix the date after which no drug which is not registered shall be allowed to be exported, imported, manufactured, stored, distributed or sold.
(7) A person applying for the registration of a drug shall furnish such information in respect of the drug as may be prescribed, including information relating to its efficacy, safety, and quality, or as may be required by the Registration Board for the purpose of the evaluation of the drug.
(8) Single-ingredient drugs shall be registered generally by their generic names while compound drugs shall be registered generally by their proprietary names.
Explanation: In this sub-section,--
(a) "single-ingredient drugs" means drugs containing one active ingredient;
(b) "compound drugs" means drugs containing more than one active ingredient.
[(9) The registration of a drug shall be subject to such conditions as may be prescribed.]
(10) Where the Registration Board registers a drug, it shall inform the person applying for its registration and the Provincial Governments of its having done so and of the conditions subject to which it has been registered.
(11) If the Registration Board, on the basis of information received or an inquiry conducted by it, is of opinion that—
(a) the registration of a drug was procured by fraud or misrepresentation; or
(b) the circumstances in which a drug was registered no longer exist; or
(c) there has been a violation of the conditions subject to which a drug was registered; or
(d) it is necessary in the public interest so to do;
the Registration Board may, after affording to the person on whose application the drug was registered an opportunity of showing cause against the action proposed to be taken, cancel or suspend the registration or specify any further conditions to which the registration shall be subject and inform such person and the Provincial Governments accordingly.
(12) The Provincial Governments shall take all such steps as may be necessary to ensure compliance with the conditions subject to which a drug is registered and to prevent the manufacture or sale of a drug--.
(a) which has not been registered; or
(b) the registration of which has been cancelled or stands suspended.
8. 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.
9. Appellate Board : (1) The: Federal Government shall, in accordance with the rules, constitute an Appellate 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 Authority to which the powers of the Federal Government under section 12 have been delegated under sub-section (3) of that section and for revision of any such decision on its own motion.
(2) The Appellate Board shall consist of such representatives of the Federal Governments and the Provincial Governments, including a Chairman, as the Federal Government may from time to time appoint.
(3) Subject to sub-section (4), the Chairman and other members of the Appellate.-Board shall hold office for the prescribed period.
(4) The Chairman or any other member of the Appellate Board may, by writing under his hand addressed to the Federal Government, resign his office or shall vacate his office if the Federal Government, being of opinion that in the public interest it is necessary so to do, so directs.
(5) The members of the Appellate Board shall exercise such powers, including the powers of an Inspector, as may be prescribed.
(6) The Appellate Board may appoint experts for the purposes of detailed study of any specific matter before it.
(7) The Appellate Board shall, [with the approval of the Federal Government and by notification in the official gazette,] make regulations to regulate the conduct of its business.
[(8) The Appellate Board shall meet at least every month and shall decide any appeal
preferred to it within sixty days of receipt of appeal unless the Board is prevented from doing so for sufficient cases to be recorded.]
[9A. Appeals to the Provincial Appellate Authority. - (1) Any person aggrieved by any decision of the licensing authority may prefer appeal to the Provincial Appellate Authority.
(2) The Provincial Government shall constitute a Provincial Appellate Authority for the disposal of appeal preferred under sub-section (1) as my be prescribed.]
10. Expert Committees: (1) The Federal Government may constitute committees of experts on Drugs Evaluation, on Pakistan Pharmacopoeia, on Advertising and on such other matters as may be necessary for the purposes of this Act.
(2) Each committee constituted under sub-section (1) shall consist of such members as the Federal Government may appoint from time to time and each such member shall hold office during the pleasure of the Federal Government.
11. Provincial Quality Control Board: (1) Each Provincial Government shall set up a Provincial Quality Control Board consisting (3f such members, including a Chairman, as that Government may appoint from time to time.
(2) The Chairman and other members of the Provincial Quality Control Board shall hold office during the pleasure of the Provincial Government, on such terms and conditions as that Government may determine.
(3) 'The provincial Government shall appoint a person to be the Secretary of the Provincial Quality Control Board and provide the Board with such staff as the Provincial Government may consider necessary.
(4)The Provincial Quality Board shall, [with the approval of the Provincial Government and by notification in the official gazette,] make regulations to regulate the conduct of its business.
(5) The following shall be the powers and functions of the Provincial Quality Control Board, namely:--
(a) to inspect any premises where any drug is being or is to be, manufactured or sold and to recommend to the appropriate authority the cancellation or suspension of the licence to manufacture or sell drugs granted to any person who is found to be contravening, or to have contravened, any of the provisions of this Act, or the rules;
(b) to scrutinize the reports of Provincial Inspectors in respect of contraventions of this Act and 'reports of the Government Analysts in respect of drugs Sent to them by the Provincial Inspectors for test and analysis and issue instructions to the Inspectors to the action to be taken on such reports:
Provided that the Provincial Quality Control Board may specify the class of cases in which a Provincial Inspector may make a complaint to the Drug Court, or take any other action, without the specific instructions of the Board;
(c) to exercise all the powers of an Inspector under this Act and the rules;
(d) to advise the Provincial Government on ways and means to ensure quality control of drugs manufactured in the Province;
[(e) to ascertain the names of such directors, partners and employees of the company, corporation, firms or institution who are prima facie responsible for the commission of any offence under this Act or the rules and allow an inspector to institute prosecution only against such persons;
(f) to conduct annual validation of all instruments in the provincial drug testing laboratories and to recommend measures to upgrade such laboratories, if required;
(g) identify and accredit on payment of fee other laboratories in the Province with suitable facilities and expertise;
(h) to conduct training programs to update Government Analysts and for improving their knowledge according to latest analytical method and technology; and
(i) to submit a monthly report of decisions and activities to the Federal Government. ]
(6) The Provincial Quality Control Board may entrust any of its powers or functions under sub-section (5) to any one or more of its members.
[11A. Conflict of interest. - No person who is a member of the Appellate Board, Central Licensing Board, a Provincial Quality Board, the Registration Board or a member of Expert Committee shall be a member of the any other board or committee of which he is a member to avoid any conflict of interest.]
12. Power to fix maximum prices of drug, etc.: (1) The Federal Government may, by notification in the official Gazette,--
(a)fix the maximum price at which any drug specified in the notification is to be sold; and
(b) specify a certain percentage of the profits of manufacturers of drugs which shall be utilized, in accordance with the rules for purposes of research in drugs.
(2) For the purpose of the exercise of its powers under sub-section (1), the Federal Government may require a manufacturer, stockist, importer, exporter, retailer or other dealer in drugs to furnish such relevant information as may be necessary.
(3) The Federal Government may, by notification in the official Gazette, delegate any of its powers under this section .to any Board or other authority.
13. Directions to Provincial Governments: The Federal Government may give such directions to a Provincial Government as may appear to the Federal Government to be necessary for carrying into execution in the Province of any of the provisions of this Act or of any rule or order made there under or for maintaining supplies of drugs of standard quality at reasonable prices or for the achievement of uniformity in respect of any matter in different parts of Pakistan.
14. Federal Drugs Laboratory and institutes etc.: The Federal Government shall, as soon as may be, establish a Federal Drug Laboratory and may also set up such other institutes and drugs testing and research laboratories for the purposes of this Act as may be prescribed.15. Provincial Drugs Testing Laboratory : Each Provincial Government shall, as soon as may be, set up a Provincial Drugs Testing Laboratory for such purposes as may be prescribed.16. Government Analysts: The Federal Government or a Provincial Government may, by notification in the official Gazette, appoint such persons 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:Provided that no person who has any financial interest in the manufacture, import, export or sale of drugs shall be so appointed:Provided further that a person serving under the Federal Government or another Provincial Government shall not be so appointed without the previous consent of that Government.
17. Inspectors: The Federal Government or a Provincial Government may, by notification in the official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Federal Inspectors, or, as the case may be, Provincial Inspectors for the purposes of this Act within such local limits as it may assign to them respectively:
Provided that no person who has any financial interest in the manufacture, import, export or sale of any drug shall be appointed:
Provided further that a person serving under the Federal Government or another Provincial Government shall not be .so appointed without the previous consent of such Government
18. Powers of, Inspectors : (1) Subject to the provisions of section 19 and of any rules made in this behalf, an Inspector may, within the local limits for which he is appointed, and in any other area within the permission of the licensing authority,-
(a) inspect any premises-wherein any drug is manufactured, the plant and process of manufacture, the means employed for standardizing and testing the drugs and all relevant records and registers;
(b) inspect any premises wherein any drug is sold or is stocked or exhibited for sale or is distributed, the storage arrangements and all relevant records and registers;
(c) take samples of any drug which is being manufactured, or being sold or is stocked or exhibited for sale or is being distributed;
(d) enter and search, with such assistance, if any, as he considers necessary, any building, vessel or place, in which he has reason to believe that an offence under this Act or any rules has been or is being committed or may continue to be committed;
(e) call any person to be present as witness in the course of search or seizure or in connection with any other matter where the presence of witnesses is necessary;
(f) seize such drug and all materials used in the manufacture thereof and any other articles, including registers, cash memos, invoices and bills, which he has reason to believe may furnish evidence of the commission of an offence punishable under this Act or any rules:
[Provided that where the contravention is such which can be remedied, the stocks shall not be seized upon undertaking in writing of the person not to sell drug without remedying the defect, under intimation to the Board concerned]
(g) require any person to appear before him at any reasonable time and place to give statement, assistance or information relating to or in connection with the investigation of an offence under this Act or the rules:
Provided that the exemptions under Sections 132 and 133 of the Code of Civil Procedure, 1908 (Act V of 1908), shall be applicable to requisitions for attendance under this Clause;
(h) lock and seal any factory, laboratory, shop, building, store-house or godown, or a part thereof, where any drug is or is being manufactured, stored, sold or exhibited for sale in contravention of any of the provisions of this Act or the rules;
(i) forbid for a reasonable period, not exceeding [two] weeks or such further period, which shall not
be more than three months, as the Inspector may, with. the approval of the Provincial Quality Control Board, the Central Licensing Board, the Registration Board, or the licensing authority, as the case may be, specify, any person in charge of any premises from removing or dispensing of any drug, article or other thing likely to be used in evidence of the commission of an offence under this Act or the rules; and
(j) exercise such other powers as may be necessary for carrying out the purposes of this Act or any rules:
Provided that the powers under causes (f) to (j) shall be exercisable only by an Inspector specifically authorized in this behalf, by an order in writing, by the Government appointing him, subject to such conditions as may be specified in such order.
[omitted]
(2) The provisions of the Code of Criminal Procedure, 1898 (Act V of 1898), in so far as they are not inconsistent with the provisions of this Act, shall apply to searches and seizures made under this Act.
19. Procedure for Inspectors: Where an Inspector seizes any drug or any other article under section 18, he shall tender a receipt therefore in the prescribed form.
(2) Where an Inspector takes a sample of a drug for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he willfully absents himself, shall divide the sample into [five] portions and effectively seal and suitably mark the same and permit such persons to add his own seal, if any, and mark to all or any of the portions so sealed and marked:Provided that, where the sample is taken from premises whereon the drug is being manufactured, it shall be necessary to divide the sample into three portions only:
Provided further that, where the drug is made up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three or four, as the case may be, of the said containers after suitably marking the same and, where necessary, sealing them:
Provided further that if the contents of one container are insufficient for the laboratory test and analysis, the Inspector may increase the number of the containers in order to make the sample sufficient for this purpose.
(3) The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same within seven days as follows :-
(i) one portion of sample he shall send to the Government Analyst concerned for test and analysis;
(ii) the second he shall send to the chairman, Provincial Quality Control Board or the Central Licensing Board or the Registration Board, as the case may be;
(iii) the third, where taken, he shall send to the warrantor, if any, named under the proviso to sub-section (3) of Section 32; and
[(iv) the fourth, where taken, he shall send to the person purporting to be its manufacturer or importer, as the case may be.]
(4) Where an Inspector seizes any drug containing any filthy or putrid substance, vermin, worm, rodent, insect or any foreign matter which is visible to the naked eye, and the sample is such that it cannot or need not be divided, he shall effectively seal and suitably mark the same and permit the person from whom he seizes the drug to add his own seal, if any, and mark to it and shall produce the same before the Drug Court or the Central Licensing Board or the Registration Board, as the case may be, before which proceedings are instituted or action is initiated in respect of the drug.
(5) Where an Inspector takes any action under section 18,--
(a) he shall as soon as practicable ascertain whether or not the drug contravenes any of the provisions of this Act and, it is ascertained that the drug does not so contravene, he shall forthwith revoke the order passed under the said section or, as the case may be, take such action as may be necessary for the return of the stock seized and payment for the samples taken, under intimation to the Board concerned;
(b) if he seizes the stock of the drug he shall, as soon as may be inform the Board concerned and take its order as to the custody thereof:
Provided that where a Federal Inspectors not competent to take action under section 30, he shall as soon as may be, report the matter and hand over the stock, if any, to the Provincial Inspector for further action under this Act.
(6) The Provincial Inspector on finding any contravention of this Act shall, unless the Board otherwise directs, always refer the case to the Provincial Quality Control
Board and seek orders as to the action to be taken in respect of such contravention.
(7) The Federal Inspector on finding any contravention of this Act for which he is authorized shall, unless otherwise directed, always refer the case to the Central Licensing Board or the Registration Board or any other authority as may be specified for the purpose and seek any further orders as to the action to be taken in respect of such contravention.
20. Persons bound to disclose place where drugs are manufactured or kept: Every person for the time being in charge of any premises whereon any drug is being manufactured or is kept for sale or distribution shall, on being required by an Inspector so to do, disclose to the Inspector the place where the drug is being manufactured or is kept, as the case may be.
21. Disclosure of the name of the manufacturer: Every person, not being the manufacturer of a drug or his agent for the distribution thereof, shall if so required by an Inspector, disclose to him the name, address and other particulars of the manufacturer or other person from whom he acquired the drug.
22. Reports of .Government Analysts : (1) The Government Analyst to whom a sample of any drug has been submitted for test and analysis under sub-section (3) of section 19 shall deliver to the Inspector submitting it a signed report in quadruplicate in the prescribed form and forward one copy thereof to the authority as may be prescribed.
(2) The Government Analyst, as far as may be, shall submit the report referred to in sub-section (1) within sixty days of the receipt by him of the sample of the drug and, if he is not able to do so for reasons beyond his control, shall communicate the reasons to the Inspector in writing and shall endorse its copy to the [Central Licensing Board or, as the case may be, the Registration Board or the Provincial Quality Control Board] who shall have the sample tested from the same or any other Government Analyst or a Government Drug Testing Laboratory or any other Laboratory and shall ensure the receipt of results of such test and analysis within a further period as may be prescribed and shall make the test report available to the Inspector for further action.
(3) On receipt of the report, the Inspector shall—
(a) deliver one copy thereof to the person from whom the sample was taken;(b) forward one copy to the warrantor, if any, named under the proviso to sub-section (3) of Section 32;
(c) forward one copy to the [Central Licensing Board or, as the case may be, the Registration Board or the Provincial Quality Control Board] for its directions as to the action to be taken; and(d) retain the fourth copy for use in any prosecution or for any other purpose.
(4) Notwithstanding anything contained in any other law for the time being in force, any document purporting to be a report signed by a Government analyst shall be admissible as evidence of the facts stated therein without formal proof and such evidence shall be conclusive unless the person from whom the sample was taken or the said warrantor has, within thirty days of the receipt of a copy of the report notified in writing to the Inspector or [Provincial Quality Board or, as the case may be, the Central Licensing Board or the Registration Board or the Drug Court] before which any proceedings in respect of the sample are pending that he intends to adduce evidence in contravention of the report.
(5) Where a person has, under sub-section (4), notified his intention of adducing evidence in contravention of a Government Analyst's report, [Provincial Quality Board or, as the case may be, the Central Licensing Board or the Registration Board or the Drug Court] may, of its own motion or in its discretion at the request either of the complainant or the accused, cause the sample of the drug lying with the Board concerned under sub-section (3) of section 19 to be sent for test or analysis to the Federal Drug Laboratory or any other laboratory specified for the purpose by the Federal Government which shall make the test or analysis and report in writing signed by, or under the authority of the person for the time being incharge of the Federal Drug Laboratory, or, as the case may be, such other laboratory, the result thereof and such report shall be conclusive evidence of the facts stated therein.
(6) The cost of a test or analysis made by the Federal Drug Laboratory or other laboratory under sub-section (5) shall be paid by the complainant or accused as the Drug Court or the Board concerned shall direct.
CHAPTER III
Prohibitions
23. Import, manufacture and sale of drug: (1) No person shall himself or by any other person on his behalf—
(a) export, import or manufacture for sale or sell
(i) any spurious drug;
(ii) any counterfeit drug;
(iii) any misbranded drug;
(iv) any adulterated drug;
(v) any substandard drug;
(vi) any drug after its expiry date;
(vii) any drug which is not registered or is not in accordance with the conditions of registration;
(viii) any drug which, by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate .any such disease or ailment, or to have any such other effect, as may be prescribed;
(ix) any drug if it is dangerous to health when used in the dosage or with the frequency, or, for the duration specified, recommended or suggested in the labeling thereof; or
(x) any drug in contravention of any of the provisions of this Act or any rule;
(b) manufacture for sale any drug except under, and in accordance with the conditions of, a licence issued under this Act;
(c) sell any drug except under, and in accordance with the conditions of, a licence issued under this Act;
(d) import or export any drug the import or export of which is prohibited by or under this Act;
(e) import or export any drug for the import or export of which a licence is required, except under, and in accordance with the conditions of, such licence;
(f) supply an incorrect, incomplete or misleading information, when required to furnish any information under this Act or the rules;
(g) peddle, hawk or offer for sale any drug in a park or public street or on a highway, footpath or public transport or conveyance;
(h) import, manufacture for sale, or sell any substance, or mixture of substances, which is not a drug but is presented in a form or a manner which is intended or likely to cause the public to believe it to be a drug;
(i) sell any drug without having a warranty in the prescribed form bearing the name and batch number of the drug issued,--
(i) in the case of a drug manufactured in Pakistan, by the manufacturer holding a valid licence to manufacture drugs and permission to manufacture that drug or by his authorized agent;
(ii) in the case of an imported drug, by the manufacturer or importer of that drug or, if the drug is imported through an indentor by such indentor; and
(j) apply an incorrect batch number to a drug.
(2) Nothing in sub-section (1) shall apply to the manufacture or subject to prescribed conditions, of small quantities or any drug for the purpose of clinical trial examination, test, analysis or personal use.
24. Control of advertisement: No person shall himself or by any other person on his behalf advertise, except in accordance with such conditions as may be prescribed,--
(i) any drug;
(ii) any substance used or prepared for use in accordance with the ayurvedic, unani, homoeopathic or biochemic system of treatment or any other substance or mixture of substances as may be prescribed;
(iii) any remedy, treatment or offer of a treatment for any disease.
Explanation: In this section, "advertise" means to make any representation by any means whatsoever for the purpose of promoting directly or indirectly the sale or disposal of a drug, a substance or a mixture of substances, a remedy or a 'treatment except the display of sign boards for a clinic, a dispensary or a hospital or such other institution offering treatment.
25. Control of samplings: No person shall distribute or cause to be distributed any drug as a sample except in accordance with such conditions as may be prescribed.
26. Control of printing of labelling: No person shall print any labelling in respect of any drug which is required to be registered under this Act but is not so registered after the date fixed by the Federal Government under sub-section (6) of section 7 or for a person who does not possess a licence under this Act to manufacture that drug.

CHAPTER IV
Offences, Penalties and Procedure
27. Penalties : (1) Whoever himself or by any other person on his behalf:
(a) exports, imports, manufactures for sale or sells any spurious drug or any drug which is not registered;
(b) manufactures for sale any drug without a licence; or
(c) imports without licence any drug for the import of which a licence is required;
shall be punishable with imprisonment for a term which shall not be less than three years or more than ten years and with fine which may extend to one lakh rupees:
Provided that the Drug Court may, for any special reasons to be recorded, award a sentence of imprisonment for a term of less than three years.
(2) Whoever himself or by any other person on his behalf—
(a) imports, manufactures for sale or sells any counterfeit drugs; or
(b) gives to the purchaser a false warranty in respect of any drug sold by him that the drug does not in any way contravene the provisions of Section 23 and is not able to prove that, when he gave the warranty, he had good and sufficient reason to believe the same to be true; or
(c) applies or permits to be applied to any drug sold, or stocked or exhibited for sale, by him, whether on the container or a label or in any other manner, a warranty given in respect of any other drug, or
(d) imports, manufactures for sales or sells any drug under a name other than the registered name; or
(e) exports, imports, manufactures for sale or sells any drug with which any substance, which should not actually be its component, has been mixed or packed so as to reduce its quality or strength or for which any such substance has been substituted wholly or in part;
shall be punishable with imprisonment for a term which may extend to seven years, [and with fine which may extend to one lakh rupees or with both.]
(3) Whoever obstructs an Inspector in the exercise of any power conferred upon him by or under this Act, or disobeys the lawful authority of any Inspector, shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to ten thousand rupees, or with both.(4) Subject to the provisions of sub-section (1), sub-section (2) and sub-section (3), whoever himself or by any other person on his behalf contravenes any of the provisions of this Act or any rule shall be punishable with imprisonment for a term which may extend to five years, or with fine which may extend to fifty thousand rupees, or with both.
28. Penalty for subsequent offence:
(1) Whoever having been convicted of an offence under sub-section (1) of section 27 is convicted for a [subsequent offence] under that sub-section shall be punishable with imprisonment for life or with imprisonment which shall not be less than five years and with fine which may extend to two lakh rupees.
(2) Whoever having been convicted of an offence under sub-section (4) of section 27 is convicted for a [subsequent offence] under that sub-section shall be punishable with imprisonment for a term which shall not be less than two years or more than ten years, or with fine which may extend to two lakh rupees, or with both.
(3) Whoever having been convicted of an offence under sub-section (4) of section 27 is convicted for a [subsequent offence] under that sub-section shall be punishable with imprisonment for a term which may extend to seven years, or with fine which may extend to one lakh rupees, or with both.
29. Forfeiture : (1) Where any person has been convicted under this Act, for contravening any such provisions of this Act or any rule as may be prescribed in this behalf, the Drug Court may order that the stock of drug or substance by means of or in relation to which the offence was committed or anything of a similar nature belonging to or in the possession of the accused or found with such drug or substance, and if such contravention is punishable under sub-section (1) of section 27, any implements used in manufacture or sale of such drug and any receptacles, packages or coverings in which such drug is contained and the animals, vehicles, vessels or other conveyances, used in carrying such drug, be forfeited to the Federal Government or, as the case may be, the Provincial Government and, upon such order being made, such .drug, substance, implements, receptacles, packages or coverings, animals, vehicles, vessels or conveyance may be disposed of as that Government may direct.
(2) Without prejudice to the provisions of sub-section (1), where the Drug Court is satisfied on the application of an Inspector or otherwise, and after such inquiry as may be necessary that a drug contravenes the provisions of this Act, the Drug Court may order that such drug be forfeited to the Federal Government or, as the case may be, the Provincial Government and, upon such order being made, such drug may be destroyed or otherwise disposed of as that Government may direct.
(3) An Inspector shall release any drug or article seized by him under this Act when he is satisfied that all the provisions of this Act and the rules with respect thereto have been complied with.
30. Cognizance of offences: (1) Subject to the provisions of Section 19, no prosecution shall be instituted under this Chapter except—
(a) by a Federal Inspector, where the prosecution is in respect of a contravention of clause (h) of sub-section (1) of section 23 or section 24 or any of the provisions of this Act or the rules relating to the import or export of drugs or the manufacture for sale, or sale, of a drug which is not for the time being registered or for the manufacture for sale of which a licence is not for the time being in force; or
(b) by a Provincial Inspector:
Provided that, where the public interest so requires, the Federal Inspector may, with the prior permission of the Federal Government, institute a prosecution for a contravention of any other provision of this Act.
(2) Notwithstanding anything contained in the Code of Criminal Procedure, 1898 (Act V of 1898),--
(a) an offence punishable under this Chapter other than an offence mentioned in sub-section (1) of section 27, shall be non-cognizable, and
(b) no Court other than a Drug Court shall try an offence punishable under this Chapter.
(3) Nothing contained in this Chapter shall be deemed. to prevent any person from being prosecuted under any other law for any act or omission which constitutes an offence punishable under this Chapter or to require the transfer to a Drug Court of any case which may be pending in any Court immediately before the establishment of the Drug Court.
31. Drug Courts : (1) The Federal Government may, by notification in the official Gazette, establish as many Drug Courts as it considers necessary and, where it establishes more than one Drug Court, shall specify in the notification the territorial limits within which, of the class of cases in respect of which, each one of them shall exercise jurisdiction under this Act.
(2) A Drug Court shall consist of a person who is, or has been, or is qualified for appointment as, a Judge of a High Court, who shall be the Chairman, and two members being persons who, in the opinion of the Federal Government, are experts in the medical or pharmaceutical fields:
[Provided that for deciding applications of bail the chairman any one member shall constitute full
quorum of a Drug Court.]
(3) A Drug Court shall sit at such place or places as the Federal Government may direct.
(4) A Drug Court shall have all the powers conferred by the Code of Criminal Procedure, 1898 (Act V of 1898), on a Court of Session exercising original jurisdiction.
(5) A Drug Court shall not merely by reason of a change in its composition, be bound to recall and rehear any witness who has given evidence, and may act on the evidence already recorded by or produced before it.
(6) A Drug Court shall, in all matters with respect to which no procedure has been prescribed by this Act, follow the procedure prescribed by the Code of Criminal Procedure, 1898 (Act V of 1898), for the trial of summons cases by Magistrates.
(7) A person sentenced by a Drug Court may prefer an appeal to a Bench of the High Court consisting of not less than two Judges within thirty days of the judgment.
(8) The provisions of Sections 5 and 12 of the Limitation Act, 1908 (IX of 1908), shall be applicable to an appeal referred to in sub-section (7).
32. Pleas: (1) Save as hereafter provided in this section, it shall be no defence in a prosecution under this Act to prove merely that the accused was ignorant of the nature, substance or quality of the drug 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) A drug shall not be deemed to be misbranded or adulterated or sub-standard only by reason of the fact that there has been added thereto some innocuous substance or. ingredient because the same is required for the manufacture or preparation of the drug fit for carriage or consumption and not to increase the bulk, weight or measure of the drug or to conceal its inferior quality or other defect or there is a decomposed substance which is the result of a natural process of decomposition:
Provided that such decomposition is not due to any negligence on the part of the manufacturer or the drug or the dealer thereof and that it does not render the drug injurious to health or does not make it substandard.
(3) A person, not being the manufacturer of a drug or his agent for the distribution thereof, shall not be liable for a contravention of section 23 if he proves—
(a) that he did not know, and could not with reasonable diligence have ascertained, that the drug in any way contravened the provision of this Act and that the drug while in his possession remained in the same state as when he acquired it; and
(b) that he acquired the drug from a duly licensed manufacturer or his authorized agent or an importer or an indentor resident in Pakistan under a written warrant, in the prescribed form stating, in particular. the batch number of the drug and signed by such person that the drug does not in any way contravene the provisions of Section 23 and that the drug while in his possession was properly stored and remained in the same state as when he acquired it and that the drug has been manufactured by a manufacturer holding a valid licence to manufacture drugs and permission to manufacture that drug:
Provided that a defence under clause (b) shall be open to a person only—
(i) if he has, within seven days of the service on him of the summons, sent to the Inspector a copy of the warranty with a written notice stating that he intends to rely upon it and giving the name and address of the warrantor, and
(ii) if he proves that he has, within the same period, sent written notice of such intention to the said warrantor.
33. Application of law relating to customs and powers of officers of customs : (1) The law for the time being in force relating to customs and to goods the import of which is prohibited by or under the Customs Act, 1969 (IV of 1969), shall, subject to the provisions of section 27 of this Act, apply in respect of drugs the import of which is prohibited under this Act, and officers of customs and officers to whom any of the functions of an officer of customs have been entrusted under the said Act shall have the same powers in respect of such drugs as they have for the time being in respect of such goods as aforesaid.
(2) Without prejudice to the provisions of sub-section (1), an officer of customs or a Federal Inspector or any other person as may be authorized by the Federal Government in this behalf may detain any imported package which he suspects to contain any drug the import of which is prohibited under this Act, and shall forthwith report such detention to the licensing authority and, if required by it, forward the package or samples of any suspected drug found therein to a laboratory specified by it.
34. Offences by companies, etc.: Where the person guilty of an offence under this Act, is a company, corporation, firm or institution, every director, partner and employee of the company, corporation, firm or institution [with whose knowledge or consent the offence was committed shall be guilty of the offence]
35. Publication of offender's name: (1) If any person is convicted of an offence under this Act, it shall be lawful for the Drug Court to cause the offender's name, place of residence, the offence of which he has been convicted and the penalty which has been inflicted upon him, to be published at the expense of such person in such newspapers or in such other manner as the Court may direct.
(2) The expenses of such publication shall be recoverable in the same manner as a fine is recoverable.
36. Powers to exempt : Notwithstanding anything contained in this Act, the Federal Government may, if it is of opinion that the public interest so requires, at any time, of its own motion or on a representation made to it, by notification in the official Gazette, exempt any drug or class of drugs from the operation of any of the provisions of this Act, subject to such conditions, if any, and for such period, as may be specified in the notification.
37. Inspectors to be public servants : Every Inspector shall be deemed to be a public servant within the meaning of section 21 of the Pakistan Penal Code (Act XLV of 1860), and shall be officially subordinate to such authority as the Government appointing him may specify in this behalf.
38. Indemnity : Except as otherwise expressly provided in this Act, no suit, prosecution or other legal proceeding shall lie against Government or any other authority or person for anything which is in good faith done or intended to be done under this Act or any rule.
39. Finality of order, etc.: Save as otherwise expressly provided in this Act, every order passed or decision given by any Board, a Drug Court or any other authority under this Act shall be final and shall not be called in question by or before any Court or other authority.
40. Publication of result of test or analysis, etc.: (1) It shall be lawful for the Federal Government to publish, in such manner as it may deem fit, the result of any test or analysis of any drug for public information and to pass such orders relating to the withdrawal of such drug from sale and its disposal as it may consider necessary.
(2) The Federal Government may, if it considers it necessary in the public interest so to do, publish for public information, in such manner as it may deem fit, any information relating to a drug or to the use of a drug in specified circumstances.
41. Cancellation or suspension of licences: Where any person has been found to have contravened any of the provisions of this Act, or the rules in respect of any drug and the contravention is of such a nature that the import, export, manufacture or sale of any drug by such person is, in the opinion of the licensing authority or the Central Licensing Board, likely to endanger public health, that authority may, after giving such person an opportunity of being heard, cancel the licence to import, export, manufacture or sell drugs issued to such person or suspend such licence for a specified period.
42. Cancellation or suspension of registration of registered drugs: Where any person has been found to have contravened any of the provisions of this Act, or the rules in respect of any registered drug, the Registration Board may, after giving such person an opportunity of being heard, cancel the registration of such drug or suspend such registration for a specified period.

CHAPTER V
Miscellaneous
43. Power of Federal Government to make rules: (1) Subiect to section 44, the Federal Government may, by notification in the official Gazette, make rules for carrying out the purposes of this Act.
(2) In particular and without prejudice to the generality of the foregoing provision, such rules may-
(a) prescribe the functions of the Federal Drug Laboratory and any other laboratory set up under section 14 or specified under section 22 or section 33 and the procedure for the submission to any such laboratory of samples of drugs for analysis or test, the forms of the laboratory's reports thereon and the fees payable in. respect of such reports and such other matters as may be necessary for any such laboratory to perform its functions;
(b) prescribe specifications, including the strength, potency, purity, quality or other property, of any drug, and the methods of test or analysis to be employed in determining whether a drug is of required specifications:
(c) prescribe the maximum proportion of any poisonous or other substance which may be added to or contained in any drug, or extracted or omitted therefrom; prohibit the import, manufacture, sale or stocking or exhibition for sale or distribution of any drug in which that proportion is exceeded and specify substances which shall be deemed to be poisonous;
(d) specify the drugs or classes of drugs for the import or export of which a licence is required, the testing of such drugs, and prescribe the form and conditions of such licences, the authority empowered to issue the .same, and the fees payable therefore;
(e) prescribe the places at which any specific drug or drugs may be imported, prohibit their import at any other place, and control their import through any specified agency;
(f) prescribe the evidence to be supplied, whether by accompanying documents or otherwise, of the quality of drugs sought to be imported, the procedure of officers, of customs in dealing with such evidence and the manner of storage at places of import of drugs detained pending admission;
(g) prescribe the forms of licences for the manufacture for sale of drugs or any specified drugs or class of drugs, the form of application for such licences, the conditions subject to which such licence may be issued, the person under whose signature the same be issued and the fees payable therefore;
(h) require the date of manufacture and the date of expiry of potency to be clearly and truly stated on the label' and container of any specified drug or class of drugs and prohibit the sale, stocking or exhibition for sale or distribution of the said drug or class of drugs after the expiry of a specified period from the date of manufacture or after the expiry date and prescribe the manner of disposal of such drug or class of drugs;
(i) prescribe the conditions to be observed in the packing in bottles, packages and other containers of drugs and prohibit the sale, stocking or exhibition for sale or distribution of drugs packed in contravention of such conditions;
(j) regulate the mode of packing and packaging, including its size, dimensions, fill and other specifications, the material used therefore and mode of labelling packed drugs and prescribe the matters which shall or shall not be included in such labels or on the leaflets accompanying the drugs;
(k) require that the non-proprietary or chemical or accepted scientific name or the proprietary name of any specified drug or any ingredient thereof shall be displayed in the prescribed manner;
(l) prescribe the requirements and conditions in respect of good practices in the manufacture and quality control of drugs;
(m) prescribe conditions for distribution of samples for sales promotion of drugs; prescribe the procedure for introduction in Pakistan of a new drug;
(o) prescribe terms and conditions of members of the Central Licensing Board and the Registration Board;
(p) prescribe types of registration of drugs, the form of application for such registration, the conditions subject to which such registration may be granted, the manner of registration and post-registration and surveillance and deregistration of registered drugs and the fees payable therefore;
(q) prescribe conditions for registration of indentors, importers, wholesalers and distributors within Pakistan and any establishment within any foreign country engaged in the manufacture for export of a drug and prescribe conditions providing effective and adequate means, by arrangement with the Government of such foreign country or otherwise, to enable the licensing authority or the Registration Board to determine from time to time whether drugs manufactured in such establishment, if imported or offered for import into Pakistan, shall be refused admission where the public interest so requires;
(r) prescribe the form of warranty for manufactured drugs;
(s) specify offences in relation to which the stock of drugs, articles or things shall be liable to forfeiture under this Act;
(t) prescribe the qualifications, and regulate the procedure for exercise of powers and performance of functions, of Federal Inspectors;
(u) prescribe the laboratories to which the Federal Inspectors shall submit samples of drugs taken for the purpose of test and analysis and the form and procedure for submitting the report of such test and analysis and the fee payable therefore, where so required;
(v) prescribe measures for securing and maintaining supplies of drugs at reasonable prices, conditions to be met in respect of manufacture, production, pricing, keeping, movement and disposal of drugs and to fix prices, commissions, discount of the manufacturer, wholesaler, distributor, retailer or any other dealer of drugs, to control giving of bonus in cash or kind or in any other manner to any of the said parties and for collecting or calling for any information, statistics, records or books with a view to regulating the matters aforesaid;
(w) specify drugs which may be advertised and the conditions subject to which such drugs may be advertised;
(x) prescribe conditions subject to which small quantities of drugs may be imported or manufactured or exported for the purpose of examination, test or analysis, clinical trial or personal use; and
(y) prescribe any other matter which is to be, or may be, prescribed by the Federal Government.
(3) The power to make rules conferred by this section shall, except on the first occasion of the exercise thereof, be subject to the condition of previous publication.
44. Power of the Provincial Government to make rules: (1) The Provincial Government may by notification in the official Gazette, make rules in respect of the following matters, namely :--(a) the establishment of laboratories for testing and analyzing drugs;
(b) the qualifications and the procedure, for exercise of powers and performance of functions of Provincial Inspectors;
(c) the forms of reports to be given by Government Analysts and the manner of application for test or analysis and the fees payable therefore;
(d) the conditions to regulate sale or storage or distribution of drugs or any specific drug or class of drugs;
(e) the offences against this Act or any rule in relation to which the stock of drugs shall be liable to confiscation and destruction under this Act;
(f) the forms of licences for the sale or distribution of drugs or any specified drug or class of drugs, the authority empowered to issue the same, the form of applications for such licences, the fees payable therefore and the condition subject to which such licences may be issued;
(g) the procedure to be followed by the Provincial Quality Control Board; and any other matter which is to be or may be, prescribed by the Provincial Government.
(2) The power to make rules conferred by this section shall, except on the first occasion of the exercise thereof, be subject to the condition of previous publication.
45, Repeal and savings : [(1) The Drugs Act, 1940 (XXIII of 1940), the Drugs (Generic Names) Act, 1972 (XXIV of 1972), and the Drugs Ordinance, 1976 (IV of 1976), are hereby repealed.
(2) Notwithstanding the repeal of the Drugs Act, 1940 (XIII of 1940), by sub-section (1),--
(a) any licence to manufacture for sale issued thereunder to any person, for the revalidation of which an application has already been made to the Central Licensing Board within the date specified by the Federal Government shall continue to be valid until orders are passed by the said Board in this behalf;
(b) any licence for import or export or sale of drugs issued thereunder to any person, shall, unless it expires earlier under the terms thereof, continue to be valid for such periods as the Federal Government, or as the case may be, the Provincial Government may by notification in the official Gazette, specify in this behalf:
Provided that in case of drugs to be imported or exported licences may continue to be issued under the rules framed under the Drugs Act, 1940, till the rules under this Act are framed or, as the case may be, a date is fixed under sub-section (6) of section 7 in respect of drugs in the finished form ready for use.
[ Ordinance No CXXVIII dated 15th Nov. 2002]
Annex 2

THE MEDICAL AND DENTAL DEGREES ORDINANCE (XXVI OF 1982)
[31ST October, 1982]
An ordinance to repeal and with certain modifications
Re-enact the Medical Degree Act, 1916

Preamble: Whereas it is expedite to repeal and with certain modifications re act the medical Degrees Act, 1916(VII of 1916);
And whereas the President is satisfied that circumstances exist which render it necessary to take immediate action;
Now therefore, in pursuance of the Proclamation of the fifty day of July, 1977, and in exercise of all powers enabling him in that behalf, the President is pleased to make and promulgate the following Ordinance:
1. Short Title, extent and Commencement:
(1) This Ordinance may be called the Medical and Dental Degrees Ordinance, 1982.
(2) It extends to the whole of Pakistan.
(3) It shall come into force at once.

2. Definition: In this Ordinance, “Scientific Medical and Dental System, means the scientific methods of Allopathic Medicine, Obstetrics, surgery and Dentistry, but does not include the Homeopathic, Ayurvedic or Unani system of Medicine.

3. Right to Confer degrees, etc.: The right of conferring, granting or issuing in Pakistan degrees, diplomas, Licenses, certificates, or other documents stating or implying that the holder, grantee or recipient thereof is qualified to practice Scientific Medical and Dental System shall be exercisable only by the authorities specified in the schedule and by such other authority as the Federal Government or a Provincial Government may, by notifications in the official Gazette, and subject to such conditions as it thinks fit to impose, authorize in this behalf.
4. Prohibition of un authorized conferment of degrees, etc.: Saves as provided by Section 3, no person in Pakistan shall confer, grant or issue any degree, diploma, license, certificate or other document stating or implying that the holder, grantee or recipient is qualified to practice Scientific Medical and Dental system
5. Contravention of Section 4: Whoever contravenes the provisions of section 4 shall be punishable with rigorous imprisonment for a term which shall not be less than one year or more than five years and shall also be liable to fine which may extend to fifty thousand rupees and if the person so contravening is an association every member of such association who knowingly and willfully authorizes or permits the contravention shall be punishable with rigorous imprisonment for a term which shall not be less than one year or more than five years and shall also be liable to fine which may extend to twenty five thousand rupees.
6. Penalty for falsely assuming or using Medical and Dental Titles: Whoever voluntarily and falsely assumes or uses any degree, diploma, license or certificate conferred, granted or issued by any authority referred to in Section 3 or recognized by the Medical and Dental Council of Pakistan or uses any words to give a false impression that he was qualified to practice Scientific Medical and Dental System shall be punishable with rigorous imprisonment for a term which shall not be less than one year or more than five years and shall be liable to fine which may extend to fifty thousand rupees:
Provided that nothing in the section shall apply to the use by any person of any title, description or addition which he uses by virtue of any degree, diploma, license or certificate conferred upon him or granted issued to him in any subject other than medicine.
7. Cognizance of offences: Not Court shall take cognizance of an offence punishable under this Ordinance except upon a complaint made by the Secretary of Medical and dental Council or any person authorized by the Secretary and notified in the official Gazette.
8. Jurisdiction of Magistrate: No Court inferior to that of Magistrate of the first class shall try an offence punishable under this Ordinance.
9. Offence to bail-able: Notwithstanding anything contained in the code of criminal Procedure, 1898 (Act V of 1898), all offences punishable under this Ordinance shall be liable.
10. Repeal: The Medical Degrees Act, 1916 VII of 1916), here by repealed.


SCHEDULE
(See Section 3)
I. Every University in Pakistan established by an Act of the Federal Provincial Legislature.
II. College of Physicians and Surgeons of Pakistan.

Annex 3

ALLOPATHIC SYSTEM (PREVENTION OF MISUSE)
ORDINANCE LXV OF 1962
[7TH June, 1961]
An ordinance to prevent the misuse of the allopathic system of medicine and to provide for matters connected therewith
Preamble: Whereas it is expedient to prevent the misuse of the allopathic system of medicine and to provide for matters connected therewith;
Now, therefore, in pursuance of the proclamation of the seventh day of October, 1958, and in exercise of all powers enabling him in that behalf, the president is pleased to make a promulgate the following Ordinance:
1. Short title, extent and commencement:
(1) This ordinance may be called the allopathic system (prevention of misuse) Ordinance, 1962.
(2)It extends to the whole of Pakistan.
(3) It shall come into force at once.
2. Definition: In this ordinance, unless there is anything repugnant in the subject of context, “registered medical practitioner” means a person registered under the Medical council’s Ordinance, 1962.
3. Prohibition of the use of the word “doctor” and its variations, etc: No person practicing the allopathic, homeopathic, ayurvedic, unani or any other system of medicine shall use with his name or address or with the name or address of his business the word “doctor” or any of its grammatical variations, cognate expression or abbreviations so as to give out that he is entitled to practice medicine unless he is a registered medical practitioner:
4. Prohibition of the use of medical degrees or diplomas: No person shall use a medical degree or medical diploma to give out that he is a qualified medical practitioner or for any purpose connected with the medical practice, unless such degree or diploma has been conferred or awarded by a university or institution in or outside Pakistan recognized under the medical Council’s Ordinance, 1962.
5. Prohibition of performing surgical operations by unqualified persons: No person other than a registered medical practitioner shall perform any surgical operation other than circumcision, incision of boils and administration of injections.
6. Prohibition for prescribing certain drugs: No person other than a registered medical practitioner or a person authorized in this behalf by the Provincial Government shall prescribe any antibiotic or dangerous drug specified in the rules made under this Ordinance.
7. Restriction on the sale of patent and proprietary medicines: No person shall sell in the market any patent or proprietary medicine of the unani, ayurvedic, homeopathic or biochemical system of medicine unless there is displayed, in a conspicuous and readily intelligible manner, on the label or container thereof and also on the outer cover of the container (other than ordinary wrapper) the true formula of the medicine contained in it.
8. Rule making powers of the provincial Government: The Federal Government may make rules for carrying out the purpose of this Ordinance.
9. Penalty: Whoever contravenes the provisions of Section 3 or Section 4 of Section 5 or Section 6 or Section 7 shall be punishable with imprisonment which may extend to one year or with fine not exceeding two thousand rupees, or with both.
10. Jurisdiction:
(1) No prosecution shall be instituted under this Ordinance except by an inspector appointed under the drugs Act, 1940, or by a person specially empowered by the Provincial Government in this behalf.
(2) No court inferior to that of a magistrate of the 1st Class shall try an offence punishable under this Ordinance and notwithstanding anything contained in section 32 of the code of criminal Procedure, 1898, it shall be lawful for such Magistrate to pass any sentence of fine to the extent provided for by this Ordinance in excess of his powers under the said Section 32.
11. Protection: No suit or proceeding shall lie against any Inspector or person acting in good faith under Section 10 of this Ordinance.

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