Forensic Pharmacy Complete Notes

GM Hamad
Table of Contents
01 General Introduction 01
02 Role of Forensic Pharmacist 23
03 Pharmaceutical Ethics 27
04 Study of Drug Laws 31
05 The Pharmacy Act 1967 67
06 Control of Narcotic Substances Act 1997 76
07 The Poisons Act 1919 84
08 The Factories Act 1934 86
09 Shops and Establishments Ordinance 1969 100
10 Past Papers 104

Chapter 1 – General Introduction
GM Hamad Muhammad Muneeb
GENERAL INTRODUCTION
FORENSIC PHARMACY AND FORENSIC PHARMACIST
FORENSIC PHARMACY (Past Papers)
 Forensic pharmacy is application of the sciences of drugs to legal issues.
Forensic pharmacists engage in work related to litigation, the regulatory
process, and the criminal justice system.
 Forensic pharmacy overlaps with many other forensic fields and
Pharmacists hold a variety of positions with local, state, and federal
governments.
FORENSIC PHARMACIST
 A forensic pharmacist can be a valuable resource in legal cases relating
to malpractice, adverse drug reactions, drunk and drugged driving,
health care fraud, poisoning, and numerous other types of civil and
criminal cases.
 A forensic pharmacist's job responsibilities are slightly different than a
forensic scientist's duties because a forensic pharmacist specifically
applies the science of drugs to legal matters.
 Forensic pharmacists spend much of their time researching, testing and
analyzing drug-related evidence for lawyers to use in litigation as part of
the criminal justice system.
HISTORY OF PHARMACY EDUCATION IN PAKISTAN
 Pharmacy education was started in the province of Punjab of sub-
continent in year 1944 within pharmacology department of King Edward
Medical College (K.E.M.C), Lahore.
 Initially, K.E.M.C. offered a 3-year degree course along with a 2-year
diploma tracked by 3 months of practical training in Pharmacy.
 Later on due to its wider prospects the department of Pharmacy was
undertaken by the Punjab University, Lahore.
 In the year 1948 an independent Pharmacy department was established
in Punjab University, Lahore in the present location, which is known as
Allama Iqbal Campus.
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 Initially at Punjab University, the education of Pharmacy was taught in
various institutions in and out of the University. The Physiology and
Pharmacology departments of King Edward Medical College helped the
department of Pharmacy in teaching subjects of Physiology and
Pharmacology, the subject of Pharmacognosy and Pharmaceutical
chemistry were taught in the department of Botany, Government
College, Lahore and in the department of Chemistry, University of the
Punjab, Lahore respectively. Pharmaceutics, however, was taught at
present premises of the Pharmacy department.
 In 1958 all the subjects were taught in the Department of Pharmacy.
With the development of well-equipped research laboratories and
additional facilities, the university started master and doctoral programs
in Pharmacy in 1966 and 1974 respectively.
 The department was up-graded to the level of faculty in 1979 and 3-
years bachelor’s course was transformed into 4-years degree program,
another major milestone in the history of Pharmacy.
 Later on, in 2003, its status was further up-lifted to the level of College
and it is known as University College of Pharmacy. Thereafter, 4-year of
Bachelor of Pharmacy was changed to 5-years Doctor of Pharmacy
degree.
HISTORY OF DRUG LEGISLATION IN PAKISTAN
INTRODUCTION
 Pakistan has legislation namely the Drug Act, 1976.
NEED OF LEGISLATION
 To ensure the availability of safe, effective, and quality products at
reasonable prices.
KEY FEATURES OF LEGISLATION
 Before independence of Pakistan, pharmaceutical industry was
regulated by the Drugs Act, 1940 in the sub-continent. This Act provided
basic guidelines to manufacture, distribution, sale, import and export of
drugs. In order to check the standard of the drugs, central drug
laboratory was established whereas drug inspectors had been provided
for implementation of the provision of this Act.
 In 1976, Drugs Act was promulgated in order to cope the scientific
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advancement and cover the shortcomings of the Drugs Act, 1940. Drug
Act 1976 and rules made under this act are the measures to ensure
manufacture, register, import/export and sale of drugs. It includes:
The manufacture, import, export and sales of drugs without
license is banned.
Whereas the sale of the drugs in the streets is prohibited.
 Later on, following rules were made to strengthen the regulatory system
in Pakistan:
The Drugs (Licensing, Registration & Advertising) Rules, 1976
The Drugs (Import & Export) Rules, 1976
The Drugs (Labeling & Packing) Rules, 1986
 Alternative Medicines (unani, ayurvedic, homeopathic, Chinese,
biochemical etc.) & Health & OTC products (probiotics, disinfectants,
food supplements, nutraceuticals, baby milk, medicated cosmetics etc.)
were non-regulated till promulgation of “Alternative Medicines & Health
Products (Enlistment) Rules, 2014”. Provincial governments are
regulating pharma business w.r.t. distribution and sale by following
rules:
Punjab Drug Rules, 2007
Sindh Drug Rules, 2010
KPK Drug Rules, 2017
Baluchistan Drug Rules, 2018
 Punjab drug rules 2007, key features include:
Pharmacy and medical store
 Medical Store means premises where drugs are excluding
the drugs specified in the Schedule G are stored, sold or
offered for sale.
 Pharmacy means premises where drugs are stored, sold,
compounded, dispensed or prepared on prescription or
distributed in case of authorized agent of manufacture, or
importer.
 The DRAP Act 2012
The DRAP Act, 2012 promulgated and established a well-defined
regulatory authority to regulate licensing, registration, pricing,
quality assurance, laboratory testing, controlled drugs, pharmacy
services etc., aspects of pharmaceutical industry. The Authority
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comprises of Chief Executive Officer (CEO) and 13 Directors for
smooth working of DRAP.
Functions include:
 To provide effective coordination and enforcement of the
Drug Act 1976.
 To bring Harmony in Inter-Provincial Trade.
 Commerce of Therapeutic goods.
 The Punjab Drugs (Amendment) Bill 2015
A bill further to amend the Drug Act, 1976
Certain amendments in the Drug Act, 1976
 For the eradication of the menace of spurious drugs.
 For more effective enforcement of the law through stricter
penalties and for ancillary matters.
NATIONAL HEALTH POLICY
 Pakistan is committed to the goal of Health for all. To achieve this, the
Government is taking all possible measures in the field of health services
at large and drugs in particular.
 Formulation of the national drug policy thus forms an integral
component of its national health policy, purpose of which is to ensure
regular availability of essential drugs of acceptable efficacy, safety and
quality at affordable prices to all irrespective of their socio-economic
status or place of living.
 Towards achieving this goal, Pakistan has a drug legislation, a quality
control system, and certain other elements of a drug policy in
fragmented form, but to meet the challenges of the day, a more
comprehensive drug policy is necessary.
 The National Drug Policy encompassing all aspects of drugs which has
been formulated for the first time in Pakistan to serve as a future guide.
NATIONAL DRUG POLICY (Past Papers)
OBJECTIVES
 The specific objectives of the National Drug Policy are as under:
1. To develop and promote the concept of essential drugs and to
ensure regular, uninterrupted and adequate availability of such
drugs of acceptable quality and at reasonable prices.
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2. To inculcate in all related sectors and personnel the concept of
rational use of drugs with a view to safeguarding public health
from over-use, misuse or inappropriate use of drugs.
3. To encourage the availability and accessibility of drugs in all parts
of the country with emphasis on those which are included in the
National Essential Drugs List.
4. To attain self-sufficiency in formulation of finished drugs and to
encourage production of pharmaceutical raw materials by way of
basic manufacture of active ingredients.
5. To protect the public from hazards of substandard, counterfeit
and unsafe drugs.
6. To develop adequately trained manpower in all fields related to
drugs management.
7. To develop a research base particularly for operational and
applied research with a view to achieving the above mentioned
objectives.
8. To develop the pharmaceutical industry in Pakistan with a view to
meeting the requirement of drugs within the country and with a
view to promoting their exports to other countries.
NATIONAL ESSENTIAL DRUGS LIST (NEDL)
PREPARATION OF NEDL
 The Federal Government and each provincial government until 1993 had
their on lists of drugs for purchases for the government institutions and
thus there was lack of uniformity in these lists.
 The concept if these lists for various levels of Health Institutions was also
not distinctly defined. There was, therefore, an urgent need to prepare a
National list of Essential Drugs of Pakistan with graded lists for various
levels to be implemented uniformly both at the Federal and Provincial
levels.
 A National Essential Drugs List of Pakistan was thus prepared in 1994 in
view of the health needs of the country with the help of specialists
organizations in the field of medicines and pharmacy from all over the
country. This has already been published and circulated widely
throughout the country.
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BULK PURCHASES FOR HEALTH INSTITUTIONS
 Future bulk purchases of drugs for all government and semi-government
health institutions shall be made in accordance with this list. The NEDL
has specified the health care levels at which each essential drug is to be
used.
 Effective and well organized operating systems shall be developed for
procurement and distribution of such drugs for the population. This shall
envisage quantification of the actual needs for drugs and effective
logistics for supply.
PROMOTION OF ESSENTIAL DRUGS CONCEPT (Past Papers)
 The Essential Drug Concept and the National Essential Drug List will be
promoted in the public and private sector. Policy will be geared to
increase share of essential drugs in local production and to make such
drugs available at affordable prices where-ever needed.
 Efforts will also be made to promote rationality in essential drug
prescribing and use. To encourage this, Drug Information Sheets in line
with those of WHO model providing concise, accurate and
comprehensive information shall be prepared and widely circulated.
 A comprehensive public information shall be launched to enhance
understanding and acceptance of the Essential Drugs Concept by the
patient and the health care personnel.
 In order to promote the concept of Essential Drugs, the doctors in the
public sector shall be persuaded to prescribe rationally cost-effective
drugs from the Essential Drugs List.
 In order to encourage such practices, unbiased information about drugs
shall be published and widely circulated to the Federal and Provincial
Health Institutions.
SYSTEM OF AUDIT AND ACCOUNTABILITY
 A system of audit and accountability shall also be introduced for
monitoring the prescribing practices.
 Procurement of drugs in the public sector shall also be subject to similar
audit and accountability.
REVIEW OF NEDL
 The National Essential Drugs List will be periodically reviewed and
revised every year and made more pragmatic by a committee that
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includes competent specialists in clinical medicine, pharmacology and
pharmacy and from other related fields and published.
CRITERIA FOR SELECTION OF EDS
 For the selection of essential drugs and for establishing a national
program for the use of essential drugs, the guidelines and criteria
recommended by the WHO shall be followed.
AVAILABILITY OF EDS
 The availability of essential drugs which could be in short supply shall be
ensured through the establishment of hospital pharmacy for
manufacture of such drugs and also by providing incentives to the local
industry.
CONSTITUTION OF PTC
 All teaching divisional and district hospitals shall constitute “Pharmacy
and Therapeutic Committees” to monitor and promote rational use of
drugs in the hospitals.
GENERIC NAMES FOR EDS
 Only generic names will be used for drugs in the NEDL all public sector
drug lists, inventory sheets and tender documents.
PRESCRIPTION HANDLING AT RETAIL LEVEL AND RECORD KEEPING
HANDLING OF PRESCRIPTION
 The following procedures should be adopted by the pharmacist while
handling the prescription for compounding and dispensing:
1. RECEIVING
 The prescription should be received by the pharmacist. While
receiving a prescription, a pharmacist should not change his/her
facial expression.
2. READING AND CHECKING
 After receiving the prescription it should be screened behind the
counter. Prescription authenticity should be checked.
 The signature of the prescriber and the date of prescription should be
checked. The pharmacist should read all the lines and words of the
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prescription. If there is any doubt, the pharmacist should consult with
the other pharmacist or the prescriber over telephone.
3. COLLECTING AND WEIGHING THE MATERIALS
 Before compounding a prescription all the materials should be
collected from the shelves or drawers. All the materials shall be kept
in the left hand side of the balance. After measuring each material
should be kept on the right hand side of the balance.
 After compounding of the prescription materials are replaced back to
the shelves.
 While compounding every container of material should be checked
thrice in the following manner:
When collected from the shelves.
When the materials are measured.
When the containers are placed back to the shelves.
4. COMPOUNDING, PACKAGING AND LABELING
 Only one prescription should be compounded at a time.
Compounding should be done on a clean table. All equipment
required should be cleaned and dried.
 The preparation should be prepared according to the direction of the
prescriber or as per methods given in pharmacopoeia or formulary.
The compounded preparations should be filled in suitable containers.
At the end label the container.
RECORD KEEPING OF PRESCRIPTION
 It is recommended for pharmacists to keep the following records for a
minimum of 5 years:
A record of the purchase and supply of an unlicensed medicine.
The specification of the unlicensed medicine agreed with the
supplier. This should be documented and kept on file in the
pharmacy.
Verification of the specification of the unlicensed medicine, such
as a certificate of analysis or a certificate of conformity from the
manufacturer. This should be obtained on delivery and must
include the batch number and expiry details of the product kept
on file in the pharmacy.
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Patient details, such as name and address linked to the unlicensed
medicine should also be maintained to provide an adequate audit
trail.
The source of the product i.e. manufacturer details. The batch
number and expiry date of the product. This will be listed on
certificate of analysis or a certificate of conformity.
If the product is in response to a prescription, the records must
also include the patient’s details, prescription details and the date
of dispensing.
The date the product was supplied – as this may differ from the
date of manufacture.
DRUG CONTROL ADMINISTRATION AT FEDERAL AND PROVISIONAL
LEVEL
 After the commencement of DRAP Act 2012, the Federal Government
shall establish an Authority to be known as the Drug Regulatory
Authority of Pakistan.
 The Authority shall be an individual body having common seal and shall
work for the purposes of this Act.
 The Authority shall be an autonomous body under the administrative
control of the Federal Government with its headquarters at Islamabad.
 The Authority may set up its sub-offices provincial capitals and such
other places, as it may consider necessary from time to time.
 The common seal of the authority shall be kept under custody of CEO.
REGISTRATION OF DRUGS
ESTABLISHMENT OF REGISTRATION BOARD
1. Section 7 of Drugs Act 1976 describes the rules and regulations for
registration of drugs. The Federal Government shall register drugs in-
accordance with prescribed conditions and procedure and for that
purpose a Registration Board was set up, consisting of persons with
appropriate qualifications.
2. The members of the Registration Board shall exercise powers of an
Inspectors.
3. Registration board shall establish committees, sub-committees. RB shall
conduct meeting in every month and Agenda shall be circulated to
members.
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COMPOSTION OF REGISTRATION BOARD (Past Papers)
1. Director Registration Board (Chairman)
2. One Representative, each from Directorate of biological drugs, medical
devices and medicated cosmetics and QA and LT directorates.
3. Director DTL Punjab, Sindh, KPK and Balochistan.
4. Veterinary medicine expert at least 15 years’ experience.
5. Pharmacology expert with 15 years’ experience to be nominated by
Federal Government.
6. Hospital Pharmacy expert with at least 15 years of experience.
7. One Experts, each having at least 15 years of experience in fields of
biologicals, physician, drug manufacturing.
8. IPO representative.
9. Law expert not below BS-19 nominated by Law Division.
10.Additional director (Regular) is Secretary.
DRUG REGISTRATION (Past Papers)
1. The registration shall be granted and reviewed on the basis of
established criteria of acceptable safety, efficacy, in terms of significant
therapeutic value, quality and keeping in view real health needs of the
country and the public interest.
2. Fixed ratio combinations products will be registered only when the
dosage of each ingredient meets the requirements of a defined
population group and when the combination has proven advantage over
single compounds administered separately in therapeutic effect, safety
or compliance.
3. All irrational, unsafe and obsolete formulations and combinations shall
be de-registered. Regsitration Board can cancel or suspend the
regitration after giving show cause notice in case of discepency or
specify further conditions.
4. Application for registration given on prescribed forms:
Form 5 (local manufacture)
Form 5A (Imported drugs)
Form 5D (New molecules)
Form 5E (Patent drugs)
 The Common Technical Document (CTD) is a set of specifications for an
application dossier for the registration of medicines. New format of
dossiers for registration consists of five modules:
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Module I – Regional administrative information (Not part of CTD)
Module II – Quality over all summary (Clinical and non-clinical
summary and overviews)
Module III – Quality
Module IV – Non-clinical study reports (safety)
Module V – Clinical study reports (efficacy).
 Duration of registration certificate is 5 years unless suspended or
cancelled. Renewal is done for further 5 years. Application for renewal
shall be received within 60 days.
 Conditions of regsitration are:
Import, export in accordance with approval.
Indications, side effects, dosage and cautions etc be clearly
mentioned on labels.
Suffieient supply in market.
No shortage of the drug in market.
Can not discontinue production.
PRICING OF DRUGS
DRUGS PRICING
1. Section 12 of Drugs Act 1976 describes the rules and regulations for
pricing of drugs. Federal Govenrment shall fix price and profit margins of
drugs.
2. Drug manufacurers, stockist, importers, exporters etc are bound to
disclose relevant information to Fedral Government.
3. Fedral Government by notification in official Gazatte can delegate its
powers to committee or any other authority.
PRICING POLICY (Past Papers)
 Pricing policy notified on 12-06-2018. The definitions in said policy are:
 CPI – Consumer price index.
 Drug Pricing Committee – means committee notified under section 10
of Drug Act 1976.
 IMS data – Information medical statics. An organization which provide
pharmaceutical market information globally.
 Quintiles IMS data – information of Pharmaceutical market in Pakistan
by IQVIA, An organization which provides pharmaceutical market
information globally.
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 Landed cost – Import price + freight + custom duty + income tax paid at
import stage + insurance + bank charges + clearing charges + civil
aviation charges + other import levies (if any).
 Manufacturing cost – API cost + other raw material cost + packaging
material cost + wastage not exceeding 3% + QC cost + production cost
including labor + depreciation on plant and machinery + fuel + energy
cost + other cost as per standards.
 NCE/NBE – New chemical entity / New biological entity that has not been
registered in the same dosage form, strength and delivery system in
Pakistan.
 Originator brand – means branded drug containing a new chemical
entity through research and development.
BASIS OF PRICING
 Two categories of drugs:
1. Drugs and biologicals on National Essential Medicine list.
2. All other drugs.
 MRP of generic never exceeds originator brand except originator brand
is de-registered or manufacturer or importer confirm the non-availability
due to non-viability.
 No person including retailer, hospital, clinic, whole seller or distributor
sell any drug to any consumer at price exceeding the MRP printed on
pack. Loose quantities should be calculated on pro-rata basis.
 Stickers, overlapping or masking of price shall not be allowed to anyone.
In case of price reduction it can be permitted on request.
PRICE FIXATION OF NCE (Past Papers)
 Price fixation of originator brand of NCE shall be based on average price
of same brand, in same strength in India and Bangladesh.
 If originator brand of NCE has not been marketed in India or Bangladesh:
Than check average price of basket countries namely, Indonesia,
Philippines, Lebanon, Sri Lanka and Malaysia.
If not available in these countries than check average wholesale /
procurement price available in:
 UK monthly index of medical supplies or BNF.
 Australian pharmaceutical benefit scheme.
 New Zealand pharmaceutical management agency.
 If price is not available in above references than average price of
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remaining one or two references are checked.
 If price fixation is not done as above than fixed on basis of trade price
grossed up to 15% retailer margin.
PRICES OF GENERICS OF NCE
 Generic substitute of NCE shall be fixed at 30% less than the originator
brand price.
 Can be reduced to 20% where regulatory compliance is established such
as R&D labs, stability studies and comparative dissolution studies for
encouragement of cGMP compliance in local manufacturers.
 After 06 years or till entry of at least 3 generics / biosimilars in market
MRP of originator brand be reduced by 10% each year for 3 years and
MRP of generics shall be 15% less.
PRICES OF NEW STRENGTH / NEW PACK SIZES
 Prices for new strength or new pack sizes of already registered drugs are
calculated by following formulas:
Calculation of price of Lower strength (new strength is half of the
existing strength):
MRP = Price of higher strength – 40%
Calculation of price of Higher strength (new strength is double of
existing strength):
MRP = Price of lower strength x 100/60
DRUG DISCOUNTS AND PRICE ADJUSTMENT RULES 2006 (Past Papers)
 Retailer discount: At rate of 15% on MRP printed on pack.
 Trade discount: Discounts to licensed distributors, agents or dealer by
manufacturer or importer at reasonable rate.
 Trade price: Price after deduction of retailers discounts from MRP.
 Scope of discount: No company or firm shall allow a sum of all discounts
in cash, kind or both exceeding 40% of printed MRP.
METHOD OF PRICE ADJUSTMENT
 Within MRP approved by Federal Government, Price adjustment can be
done after expiry of 1 year (Downward or upward adjustment) from date
of last adjustment.
 Ministry of Health shall be informed in advance before price adjustment.
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No change is allowed in the approved labeling of the drug. De-
registration shall be done in case of non-compliance of these rules.
LICENSING OF DRUGS
ESTABLISHMENT OF CENTRAL LICENSING BOARD (Past Papers)
1. Section 5 of Drugs Act 1976 describes the regulations for manufacturing
of drugs. The Federal Government shall set up a Central Licensing Board.
2. Types of Licenses to manufacture drugs:
a. By way of basic manufacture.
b. By way of semi-basic manufacture.
c. By way of formulation.
d. By way of repacking.
e. For experimental purposes.
3. For manufacture on more than one set of premises separate application
is required. Application is given by Form 1 or 1-A. The shortcomings in
application are pointed out and applicant has to complete it.
4. Certificate of Drug Manufacture License (DML) is issued on Form 2
having duration of 5 years and can be suspended or cancelled in case of
any discrepency.
5. Renewal of application shall be done before expiry. Renewal can also be
entertained within 60 days after expiry however additional fee will be
required.
COMPOSTION OF CENTRAL LICENSING BOARD (Past Papers)
1. Director Drug Licensing, DRAP ex-officio (Chairman)
2. One representative of Directorate of QA and LT.
3. Drug Controller or Chief Inspector of Drugs of Punjab, Sindh, KPK and
Balochistan.
4. Two experts with at least 15 years’ experience in production of drugs to
be nominated by Federal Government.
5. Two experts of QC or QA in drugs with at least 15 years’ experience.
6. Two professors of Pharmacy from public or private university.
7. One law expert nominated by Law Division not below BS-19.
8. Additional Director Licensing shall be exofficio secretary.
MEETING OF CENTRAL LICENSING BOARD
 Chairman or on the direction of CEO meeting can be called anytime.
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 In absence of Chairman Board may elect one member as chairman to
preside the meeting.
PROCEDURE FOR LICENSING
• Central Licensing Board through panel of inspectors inspect the premises
where DML is required. Initially NOC of site is issued by FID.
• Then, Lay out is approved by CLB. Building is contracted and time to time
FID visits progress. Equipment is installed in Production and QC and then
staff is appointed. Panel visits and generate report on evaluation form.
• Board considers report and if satisfied, issues DML on form 2. Specialized
part of production or QC can be done at other premises E.g Gama
radiation for sterilization.
• More than one type of licenses in same premises require one QC only.
Renewal of License is also done after inspection by the panel and its
report.
CONDITIONS FOR MANUFACTURING (Past Papers)
• For basic and semi basic manufacturing:
Manufacture under
active direction of
technical staff.
Adequate space and
equipment.
Maintained properly.
Independent QC.
Appointment of
Production and QC
Incharge.
Ventilation, HVAC.
system required.
Sanitation and hygiene.
First aid facility.
• For Formulation manufacturing:
Comply with Shedule B and B1.
Space, hygiene, staff, medical checkups, equipments, validations,
calibrations of instruments.
QC be indpendent and QA be established.
Internal audit systems and safety of staff.
Emergency exits and fire fighting systems.
Sampling and dispensing booths.
Development of qurantine, de-dusting area, approved area and
rejected item area.
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ALTERNATIVE DRUGS AND HEALTH AND OTC (Past Papers)
 Form 6 – It is manufacturer enlistment certificate for alternative
manufacturers. Under SRO 412(I)/2014.
 Form 7 – It is therapeutic goods enlistment certificate of respective
alternative drugs. Required to be issued for each alternative drug.
INSPECTORS
APPOINTMENT OF PROVINCIAL AND FEDERAL INSPECTORS
 The Federal government or a Provincial government shall by notification
in official gazette appoint such person having appropriate qualifications
as federal or provincial inspector.
POWERS OF PROVINCIAL AND FEDERAL INSPECTORS (Past Papers)
1. An inspector may with the permission of the licensing authority shall:
a. Inspect any premises where any drug is manufactured, the plant
and process of manufacture.
b. Inspect any premises where any drug is sold or is stocked or
exhibited for sale or is distributed.
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, any building, vessel or place, which he believes
offensive. Call any person to be present as witness in the course of
search or seizure.
e. Seize such drugs and all materials used in the manufacture and
any other articles, including registers, cash memos, invoices and
bills, which he considers offensive.
f. Require any person to appear before him at any reasonable time
and place to give statement, assistance or information relating to
investigation of an offence.
g. Lock and seal any factory, laboratory, shop, building, storehouse
or godown where any drug is or is being manufactured, stored
sold or exhibited for sale against the rules.
h. Forbid for 2 weeks or 3 months as the inspector may ask any
person in charge of any premises from removing or dispensing of
any drug, article or other things likely to be used in evidence
against the offence.
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PROCEDURE FOR INSPECTORS (Past Papers)
1. Where an inspector seizes any drug or any other article, he shall follow
the protocols therefore in the prescribed form.
2. Where an inspector takes a sample of a drug for the purpose of tests or
analysis, he shall divide the sample into five portions and effectively seal
and suitably mark.
3. The inspector shall restore one portion of sample, to the person from
whom he takes it and shall retain the remainder and dispose off the
same within seven days as follows:
a. One portion he shall send to the govt. analyst for test analysis.
b. The second portion he shall send to the Chairman, PQCB, or CLB.
c. The third portion he shall send to the warrantor, if any.
d. The fourth portion he shall send to the manufacturer or importer.
2. Where an inspector seizes any drug containing any filthy or putrid
substance, worm, rodent, insect, or any foreign matter which is visible to
the naked eye, and the sample is such that it cannot be divided, he shall
affectively seal and suitably mark and shall produce before the drug
court or the central licensing board.
3. Where an inspector takes any action under section 18:
a. He shall as soon as practicable ascertain whether or not the drug
violate any of the rules of this act and, if it is ascertained that the
drug does not violate, he shall revoke the order and return the
stock seized and pay for the sample taken.
b. If he seize the stock of the drug, he shall inform the respective
board and take its order as to the custody.
c. The provincial inspector on finding any violation of this act, shall
refer the case to the PQCB and seek order.
d. The federal inspected on finding any contravention of this act,
shall refer the case to the CLB or RB and seek orders.
DIFFERENCE BETWEEN FEDERAL AND PROVINCIAL INSPECTORS
QUALIFICATION OF FEDERAL INSPECTORS (Past Papers)
1. A federal inspector shall be a person who:
a. Has a degree in Pharmacy from a recognized Pakistani institute
and have 10 years practical experience in the manufacture, testing
or analysis of drugs or in drug administration.
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DUTIES OF FEDERAL INSPECTORS (Past Papers)
1. Subject to the instructions of the licensing authority, the duty of an
inspector shall:
a. To inspect twice a year, all premises licensed for the manufacture
of drugs, the means employed for standardizing and testing the
drugs, the methods and places of storage, the location,
construction, records and registers and to satisfy himself that the
conditions of the license and the rules are being observed there.
b. To inspect from time to time establishment licensed for the
import, export or sale of drugs and to satisfy himself that
conditions of the license are being observed.
c. To send licensing authority a detailed report after each inspection
indicating the conditions of the license and the rules which are
being observed and the conditions which are not being observed.
d. To take samples of any drug which he considers illegal and send
for test or analysis.
e. To give advice to Pharmaceutical industry in the technical matters
regarding the manufacture of drugs in accordance with GMP.
f. To conduct surveillance of the marketed drugs for ensuring quality
control and compliance.
g. To assist in organizing and conducting the programs for
monitoring of the adverse reactions of drugs.
h. The federal inspected on finding any violation, shall refer the case
to the Central Licensing Board (CLB) or Registration Board (RB).
QUALIFICATIONS OF PROVINCIAL INSPECTORS (Past Papers)
 No person shall be appointed as an inspector unless he holds a degree in
pharmacy from a recognized Pakistani institute.
DUTIES OF PROVINCIAL INSPECTORS (Past Papers)
1. Subject to the instructions of the licensing authority, an inspector shall:
a. Inspect a medical store, a pharmacy and a drug manufacturing
premises at least once in 3 months and maintain records of the
inspections.
b. Satisfy himself that the conditions of the license are being
observed.
c. If he has reasons to believe that a drug is being manufactured sold
stock or exhibited for sale in violation of rules of the act, he may
take samples of the drug and send for analysis and seize the drugs.
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d. Investigate any complaint made to him in writing against a person
and submit a report of his investigation to the provincial and
district board.
e. Maintain record of actions taken by him in the performance of his
duties including the taking of samples and seizures of drugs or
equipment and submit reports of such record to the provincial
and the district board.
f. Stop manufacture or sale of drugs being carried in violation of the
act and rules.
g. Inspect a place licensed under the act or the rules before renewal
of the license.
GOVERNMENT ANALYST
APPOINTMENT OF GOVERNMENT ANALYST
 The Federal government or a Provincial government shall by notification
in official gazette appoint such person having appropriate qualifications
as Federal or Provincial Government Analyst.
QUALIFICATIONS OF GOVERNMENT ANALYST (Past Papers)
QUALIFICATIONS OF PROVINCIAL GOVERNMENT ANALYST
 No person shall be appointed as a government analyst unless he holds a
degree in pharmacy from a recognized Pakistani institute and has at
least 3 years’ experience in the manufacture, testing or analysis of drugs
or drug control administration.
QUALIFICATIONS OF FEDERAL GOVERNMENT ANALYSTS
 A federal government analyst shall be a person who has a degree in
pharmacy or pharmaceutical chemistry or medicine from recognized
Pakistani institute and has 3 years post graduate experience in the test
and analysis of drugs or experience of the drug control administration
for a period of 5 years.
DUTIES OF GOVERNMENT ANALYST
1. A government analyst shall conduct test and analysis of the sample of a
drug sent to him and shall furnish the result of test analysis.
2. A government analyst shall forward monthly report containing results of
samples tested and analyzed during the month.
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REPORTS OF GOVERNMENT ANALYSTS (Past Papers)
1. The government analyst shall submit report within 60 days of the receipt
by him of this sample of the drug and shall make the test report
available to the inspector for further action.
2. On receipt of the report, the inspector shall:
a. Deliver 1 copy to the person from whom the sample was taken.
b. Forward one copy to the warrantor, if any.
c. Forward one copy to the CLB, PQCB for asking action to be taken.
d. Retain the 4th
copy for use in any prosecution.
3. The notified drug laboratory shall submit its report to the chairperson of
the Provincial Quality Control Board.
4. The board shall take necessary action on reports in accordance with the
act and the rules.
QUALITY CONTROL BOARDS
PROVINCIAL QUALITY CONTROL BOARD (PQCB)
 Each provincial government shall set up a Provincial Quality Control
Board consisting of members and a chairman.
 The provincial government shall appoint a person to be the secretary to
the PQCB.
 The PQCB shall with the approval of the provincial government and by
notification in Official Gazette make regulations to regulate the conduct
of its business.
POWERS AND FUNCTIONS OF PQCB (Past Papers)
1. To inspect any premises where any drug is being manufactured or sold
and to recommend to the appropriate authority the cancellation or
suspension of the license granted to any person who violates the act.
2. To inspect the reports of provincial inspectors in respect of violations of
act and reports of government analysts in respect for test and analysis.
3. To exercise all the powers of an inspector under this act and rules.
4. To advise the provincial government on ways and means to ensure
quality control of drugs manufactured in the province.
5. To ascertain the names of such directors, partners and employees of the
company or institution who are responsible for the violation of act and
allow an inspector to inspect such persons.
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6. To conduct annual validation of all instruments in the provincial drug
testing laboratories and recommend to upgrade such labs if required.
7. To conduct training programs to upgrade government analyst and for
improving their knowledge about latest analytical methods.
COMPOSITION OF PROVINCIAL QUALITY CONTROL BOARD
1. The board shall consist of:
a. Secretary to the government health department ex officio
member and chairperson.
b. Additional secretary technical to the government health
department ex official member and vice chairperson.
c. Provincial drug controller of the government or a senior most
officer of the provincial drug control administration who shall be
pharmacy graduate health department ex officio member.
d. A pharmacy professional who holds a graduate or higher degree in
pharmacy and has more than 5 years’ professional experience and
is appointed as a private member by the government for a term of
four years.
e. Pharmacologist preferably a professor of pharmacology appointed
as a private member by the government for a term of four years.
f. A professor of medicine, appointed as a private member by the
government for a term of four years.
g. District Coordination Officer (DCO) of our district ex official
member.
h. Executive District Officer (EDO) health of a district ex officio
member.
i. A pharmacist of the government health department in a district,
appointed by the government for a term of four years who shall
be the secretary of the district board.
j. The government may appoint a pharmaceutical expert and an
expert of medicine as members of the provincial board in respect
of a district for a term of four years.
DISTRICT QUALITY CONTROL BOARDS (DQCB) (Past Papers)
1. Provincial board may constitute a committee in a district to be known as
district quality Control Board comprising the following members:
a. District coordination officer of the district ex officio member.
b. Executive district officer health of the district ex officio member.
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c. A pharmaceutical expert in the district appointed by the
government.
d. An expert of medicine in the district appointed by the government
or private member.
e. Secretary of the committee.
PROCEDURE FOR QUALITY CONTROL BOARD (Past Papers)
1. An inspector or a government analyst shall submit monthly reports to
the district and provincial board, the provincial and district board shall
maintain the information in the order to monitor the quality of all the
drugs sold and to review the performance of the manufacturers and the
sellers.
2. The provincial and district board may meet at least once in a month to
review the situation of the quality control of drugs on the whole.
3. The provincial or district board shall examine the case referred to it by
an inspector and shall issue a show cause notice to the person and
provide him an opportunity for hearing before taking the action or
recommending suspension or cancellation of his license to the licensing
authority.
4. The provincial or the district board may in case of a minor violation,
direct the manufacturer or the seller to bring improvement, issue a
warning to him order the sealing and take any other action.
5. The provincial and district board may forbid a person for 3 months from
removing or disposing of a drug, article or other things likely to be used
as evidence in an offence under act or the rules.
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Chapter 2 – Role of Forensic Pharmacist
ROLE OF FORENSIC PHARMACIST
FORENSIC PHARMACIST
 Pharmacists hold numerous types of positions with local, state, and
federal agencies. Pharmacists with training in criminalistics have worked
as criminalists for police departments and crime laboratories.
 At the state level, pharmacists have worked as investigators and
inspectors for boards of pharmacy, health departments, and narcotic
bureaus. State medical examiners have employed pharmacists with
advanced training in toxicology and analytical chemistry in the capacity
of forensic toxicologists.
 The DEA has employed pharmacists as special agents, diversion
investigators, and in administrative positions. The Food and Drug
Administration (FDA) has pharmacists as consumer safety officers,
chemists, pharmacologists, interdisciplinary scientists, compliance
officers, and in management positions.
 Forensic pharmacists can assist fraud examiners and health care
administrators in reducing waste and fraud, especially if complex
therapeutic issues are involved. The most common consulting forensic
role for a pharmacist is that of the ‘‘forensic litigation consultant.’’
 Forensic pharmacists can obtain and review literature to refute the
opposing party’s arguments. Pharmacists can testify as to whether
another pharmacist was negligent in performance of his or her duties.
 Certain pharmacists have advanced education in substance abuse or
environmental toxicology and thus would be qualified to testify in those
areas. Federal rules of evidence require that an expert has special
knowledge, skill, experience, training, and/or education to be qualified
as an expert in a court of law.
 The pharmacist can educate the attorney about the predictability of the
reaction and offer an opinion whether proper monitoring and
precautions were followed.
BLOOD LEVEL
 Certain drugs have a narrow therapeutic range and need to be closely
monitored (eg digoxin, theophylline, lithium, etc.).
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 Clinical reasons for which to draw blood samples include high doses and
borderline doses, signs of toxicity occurring, lack of a therapeutic effect,
or suspected poor adherence.
 Toxicology analysis is a common part of the forensic autopsy and often
forensic pharmacists are consulted to interpret drug levels.
 Numerous changes occur postmortem that may increase or decrease the
blood level detected at autopsy.
PHARMACIST MALPRACTICE
 Pharmacists have been sued for many reasons including dispensing the
wrong medication, compounding errors, failure to detect interactions,
failure to contact prescribers about excessive dosages, and failure to
warn patients about side effects.
 Clinical pharmacists can be liable for improperly monitoring drug
therapy.
 Malpractice cases against pharmacists generally require testimony from
another pharmacist; the exception being an error that is so obvious that
even a layperson can understand it without expert testimony.
 Most lawyers will not file lawsuits against pharmacists unless an affidavit
is obtained from another pharmacist expressing an opinion of
negligence.
 This pharmacist expert witness would express an opinion supporting the
allegations of malpractice.
 The defense may have pharmacists as expert witnesses for rebuttals.
MALPRACTICE AGAINST OTHER HEALTH PROFESSIONALS
 The forensic pharmacist can assist attorneys regarding malpractice cases
of other health professionals, for example physicians and nurses.
 If the case involves an adverse drug reaction, the pharmacist can testify
about causation. The pharmacist can also testify about alternative
therapies with less risk.
 The pharmacist can provide opinions about medications that can
prevent disease complications.
DRUGS, ALCOHOL AND DRIVING
 Pharmacists have numerous skills that are useful in Driving Under
Influence (DUI) cases.
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 The forensic pharmacist can interpret the levels of blood alcohol and
discuss the typical effects from different alcohol levels.
 Pharmacists can apply pharmacokinetics to estimate the level of alcohol
at the time of the alleged event.
 Certain medications can have additive effects with ethanol, that is lower
levels of ethanol will produce greater effects. Other medications can
alter the absorption or metabolism of ethanol.
 Certain disease states may make a person susceptible to the effects of
ethanol. Pharmacists can provide input regarding these other factors
relating to alcohol consumption such as personal injury cases.
CRIMINAL CASES (Past Papers)
 Cases where the drug or poison was used as a weapon, or where
medications impair the mental capacity of the defendant or victim.
 Drugs as a causative factor for aggression have been used as a criminal
defense. This defense is more likely to be successful if the drug is a
prescribed medication rather than a substance of abuse.
 Medication effects can be an issue in determining whether a defendant
is competent to stand trial.
OFF-LABEL DRUG USE (Past Papers)
 Forensic pharmacist can review insurance claims relating to medication
therapy, especially where new and unusual uses of medications are
prescribed.
 A pharmaceutical manufacturer, before marketing a drug, has to obtain
approval from the FDA. The product’s labeling is part of this application
process. A pharmaceutical company may only market the drug for
conditions that the FDA has approved.
 However, health care providers may prescribe marketed medications for
uses other than FDA-approved uses. These are referred to as
‘‘unlabeled’’ or ‘‘off-label’’ uses.
 Patients, medical professionals, and health care organizations often
submit claims to insurance companies, seeking payment for unlabeled
uses. This may raise ‘‘red flags’’ with the insurance company. A forensic
pharmacist can review such claims and offer an opinion whether the use
is reasonable and common practice.
 Prescribing off label medications is in itself not malpractice. Many off-
label uses of medications are appropriate and medically necessary. The
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forensic pharmacist may offer testimony about the need for unlabeled
indications and provide insight into appropriate use of that medication.
FRAUD AND WHITE-COLLAR CRIME (Past Papers)
 The Association of Certified Fraud Examiners defines fraud as any
intentional or deliberate act to deprive another money or property by
means of deception.
 Types of fraud related to forensic pharmacy include:
Scientific Fraud: Submitting intentional false data for publication
in a book or journal.
Quackery: The promotion of remedies that lack scientific support
to consumers or health professionals.
Drug Diversion: Obtaining controlled substances for misuse or
abuse.
Health care Fraud: Submitting intentionally false data to insurance
companies.
Occupational Fraud and Abuse: This is in no way limited to
pharmacy and or even the health care industry.
Record Tampering: Improper changes in the writing in the medical
records after a lawsuit has been initiated or fear lawsuit after an
unexpected occurrence.
Counterfeit Drugs: Overlap exists in the above areas. For example,
diverting a controlled substance that was intended to be
administered to a Medicaid patient and subsequently billed to
Medicaid is both drug diversion and Medicaid fraud.
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Chapter 3 – Pharmaceutical Ethics
PHARMACEUTICAL ETHICS
1. SHORT TITLE AND COMMENCEMENT
1. These regulations may be called the Code of Ethical Marketing to
Health Care Professionals Regulations, 2017, to provide for conduct
of Ethical Marketing by the Pharma Industry to Physicians and other
Healthcare professionals.
2. They shall enter into force following its publication in the official
gazette.
2. PURPOSE
 The purpose of this Code is to facilitate ethical interactions between
companies having marketing authorization of therapeutic goods and
Healthcare Professionals in Pakistan.
3. GENERAL PRINCIPLES
 This code is based on following general principles:
1. The principle of Separation.
2. The principle of Transparency.
3. The principle of Documentation.
4. DEFINITIONS
1. Companies - mean organizations that develop, manufacture, sell,
market or distribute therapeutic goods including “Medical
Technologies” in Pakistan.
2. Demonstration Products – mean products that are used for training
of Healthcare Professionals or patient education.
3. Evaluation Products – mean products provided for human use, either
as free samples of single use products, or loans of reusable products
or capital equipment.
4. Outsourcing – means type of interaction between Health care
professionals and the establishments in order to promote, sell,
market or distribute their products.
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5. CONSULTING ARRANGEMENTS WITH HEALTHCARE
PROFESSIONALS
 Companies may engage Healthcare Professionals to provide services
that support research and development to advance in medical
science, develop new technologies, improve existing products and
services, educate on the safe and effective use of company products
or enhance the quality and efficacy of patient care.
6. THIRD PARTY EDUCATIONAL CONFERENCE
 A third party educational conference is a conference sponsored or
conducted by or on behalf of a professional association that is
independent of an educational/scientific/policymaking nature and for
the purpose of promoting scientific knowledge, medical
advancement or delivery of effective healthcare.
 Companies may purchase advertisements and lease booth space for
Company displays at conferences.
7. COMPANY SPONSORED TRAINING AND EDUCATIONAL
MEETINGS
 Companies may provide training and education of Healthcare
Professional on the safe and effective use of Company products,
including “hands-on” training sessions, cadaver workshops, wet lab
sessions, live surgeries, lectures and presentations.
 Companies may provide reasonably-priced meals in connection with
training and education meetings.
8. MEALS PROVIDED DURING BUSINESS MEETINGS
 Company representatives may meet from time to time with
Healthcare Professionals to discuss product features, conduct
contract negotiations, or discuss sales terms.
 For such meetings company provides meals with some predefined
rules and regulations.
9. EDUCATIONAL ITEMS
 Companies may occasionally provide items to Healthcare
Professionals that benefit patients or serve a genuine educational
function for Healthcare Professionals.
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 Educational items should be modest in cost, as determined by local
standards, and should not be provided in excess.
9. GIFTS AND ENTERTAINMENT
 Gifts are items that are provided to individual Healthcare
Professionals that do not fit into any of the categories set out in this
Code.
 Companies must not provide gifts to Healthcare Professionals even if
the item is of minimal value.
 Companies must not provide, organize or pay for recreational or
entertainment activities for Healthcare Professionals, including tours,
cultural or artistic activities, or leisure activities.
 Only those gifts shall be permissible which are of direct
utilization/benefit to the patient.
10.GRANTS AND DONATIONS
 Companies may provide research, educational and charitable grants
and donations within specified criteria and codes.
11.DEMONSTRATION AND EVALUATION PRODUCTS
 Companies may provide Medical Technologies to Healthcare
Professionals free of charge for demonstration and evaluation
purposes provided with proper documentation and markings.
12.ENSURING EFFECTIVE CODE IMPLEMENTATION
 In order to ensure effective implementation of Code principles, each
company should take the following concrete steps:
Appoint a senior executive for overseeing the compliance of Code.
Adopt practical and useful tools intended to ensure compliance
with the Code.
Provide effective and ongoing training and education on the Code.
Ensure the support of senior management and company’s board
to support the Code.
Institute appropriate internal monitoring and auditing
mechanisms.
Create safe mechanism to encourage employees who raise
concerns.
Require third parties working with company to comply with Code.
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13.UPDATE AND REVIEW OF REGULATION
 DRAP may update or revise its regulations as and when required
based on international best ethical practices.
14.VIOLATION AND PUNISHMENT
 Whosoever himself or by any other person on his behalf violates the
provisions of the DRAP Act 2012 and regulations shall be punishable
as provided for in Schedule II and III of the DRAP Act 2012.
30

Chapter 4.1 – The Drugs Act 1976
THE DRUGS ACT 1976
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. DEFINITIONS (Past Papers)
1. Adulterated drugs – means 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
Which bears or contains as an ingredient a substance other than the
prescribed substance.
2. Counterfeit drug – means a drug or 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.
3. 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.
4. Labelling – means all labels and other written, printed or graphic
matter accompanying any drug.
5. Manufacture – means all operations involved in the production of
the drug, including processing, compounding, formulating, filling,
packing, repacking, altering, ornamenting, finishing and labelling with
a view to its storage, sale and distribution, but does not include the
compounding and dispensing or the packing of any drug in the
ordinary course of retail business or on a prescription of a registered
medical practitioner or dentist or of a veterinarian and "to
manufacture" shall be construed accordingly.
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6. Misbranded drug – means a drug which is not labelled with such
directions for use and such warnings against use in indications where
its use may be dangerous to health, or against unsafe dosage or
duration of administration or application in such manner and form as
are necessary for the protection of users or as may be prescribed.
OR
Which is so colored, 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
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
7. 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:
a. The Pakistan Pharmacopoeia.
b. The European Pharmacopoeia.
c. The United States Pharmacopoeia.
d. The British Pharmacopoeia.
e. The British Pharmaceutical Codex.
f. The United States National Formulary.
8. 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.
9. Spurious drug – means a drug:
i. Which purports to be a drug but does not contain the active
ingredient of that drug.
ii. Which purports to be the product of a manufacturer, place or
country of whom or of which it is not truly a product.
iii. Which is imported or exported or sold or offered or exposed
for sale under a particular name while actually it is another
drug.
10.Sub-standard drug – means a drug which is not of specifications.
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CHAPTER II (ADMINISTRATION AND ENFORCEMENT)
3. REGULATION OF SALE OF DRUGS
 The Provincial Governments shall regulate the sale of drugs in the
prescribed manner and may for that purpose make orders, and issue
directions to the importers, manufacturers, stockists, retailers or
other dealers of drugs, as they may deem fit.
4. 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 constituted committee consist of members as the Federal
Government may appoint from time to time and each member shall
hold office during the pleasure of the Federal Government.
5. 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.
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, the Federal
Government may require a manufacturer, stockist, importer,
exporter, retailer or other dealer in drugs to furnish relevant
information which is necessary.
3. The Federal Government may, by notification in the official Gazette,
delegate any of its powers to any Board or other authority.
CHAPTER III (PROHIBITIONS)
6. 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 imitation product.
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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 labelling
thereof.
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 license issued under this Act.
c. Sell any drug except under, and in accordance with the
conditions of, a license 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
license is required, except under, and in accordance with the
conditions of, such license.
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:
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i. In the case of a drug manufactured in Pakistan, by the
manufacturer holding a valid license 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 indenter by such indenter.
j. Apply an incorrect batch number to a drug.
k. Sell or import a drug above the maximum price fixed under this
Act on which the drug shall be sold or imported.
2. Nothing descried in above shall apply to the manufacture of small
quantities or any drug for the purpose of clinical trial examination,
test, analysis or personal use.
7. CONTROL OF ADVERTISEMENT
1. No person shall himself or by any other person on his behalf
advertise, except in accordance with such conditions as may be
prescribed:
a. Any drug.
b. 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.
c. Any remedy, treatment or offer of a treatment for any disease.
CHAPTER III (PROHIBITIONS) (Past Papers)
8. PENALTIES (Past Papers)
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 license.
c. Imports without license any drug for the import of which a
license is required.
shall be punishable with imprisonment for 5 years or more than ten
years and with fine up to 5 lac rupees.
2. Whoever himself or by any other person on his behalf:
a. Imports, manufactures for sale or sells any imitation product.
35

b. Gives a false warranty to the purchaser in respect of any drug
sold by him that the drug does not in any way violates the
provisions of this act.
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.
d. Imports, manufactures for sales or sells any drug under a name
other than the registered name.
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 shall be punishable with imprisonment
up to 7 years, and with fine up to 1 lac rupees or with both.
3. Whoever obstructs an Inspector in the exercise of any power
assigned to him by this Act, shall be punishable with imprisonment up
to 1 year, or with fine up to 10,000 rupees, or with both.
4. Whoever himself or by any other person on his behalf violates any of
the provisions of this Act shall be punishable with imprisonment up
to 5 years, or with fine up to 50,000 rupees, or with both.
9. PENALTY FOR SUBSEQUENT OFFENCE
 Whoever having been convicted of an offence under subsection 1 of
section 27 and is again convicted for a subsequent offence shall be
punishable with imprisonment for life or with imprisonment of 5
years and with fine up to 10 lac rupees.
 Whoever having been convicted of an offence under subsection 2 of
section 27 is again convicted for a subsequent offence shall be
punishable with imprisonment of 2 years or more than 10 years, or
with fine up to 2 lac rupees, or with both.
 Whoever having been convicted of an offence under sub-section 4 of
section 27 is convicted again for a subsequent offence shall be
punishable with imprisonment up to 7 years, or with fine up to 1 lac
rupees, or with both.
10.FORFEITURE
1. Where any person has been convicted under this Act, for violating any
such provisions of this Act, the Drug Court may order that the stock of
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drug or substance by which the offence was committed and if such
violation is punishable, any implements used in manufacture or sale of
such drug and any packages or coverings in which such drug is
contained and the animals, vehicles, vessels used in carrying such
drug, be forfeited to the Federal Government or, as the case may be,
the Provincial Government.
2. Where the Drug Court is satisfied on the application of an Inspector,
and after required inquiry that a drug violates the provisions of this
Act, the Drug Court may order that such drug be forfeited to the
Federal Government or 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.
11.COGNIZANCE OF OFFENCES (Past Papers)
1. Subject to the penalties of this Act, no prosecution shall be instituted
except:
a. By a Federal Inspector, where the prosecution is in respect of a
violation of 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 license is not for the time
being in force.
b. By a Provincial Inspector.
2. Notwithstanding anything contained in the Code of Criminal
Procedure, 1898 (Act V of 1898):
a. An offence punishable if it is prescribed under this Act.
b. No Court other than a Drug Court shall try an offence
punishable under this Act.
3. Nothing contained in this Act shall be deemed to prevent any person
from being prosecuted under any other law for any act or omission.
12. DRUG COURTS (Past Papers)
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 the territorial
limits within which, each one of them shall exercise under this Act.
37

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.
3. A Drug Court shall sit at such place or places as the Federal
Government as the case may be, the Provincial 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.
13.PLEAS (Past Papers)
1. It shall be no defense 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 considered as misbranded or adulterated or sub-
standard only by reason that there has been added some non-toxic
substance 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 other defect or
there is a decomposed substance which is the result of a natural
process of decomposition.
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3. Any distributor of drugs, shall not be liable for a violation of this Act if
he proves:
a. That he did not know and could not assure that the drug in any
way violated the provision of this Act and the drug while in his
possession remained in the same state as when he acquired it.
b. That he acquired the drug from a duly licensed manufacturer or
his authorized agent or an importer 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 violates the provisions of this Act
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 license and permission to manufacture that drug.
14. 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

Chapter 4.2 – The Drugs Appellate Board Rules 1976
THE DRUGS APPELLATE BOARD RULES 1976
1. This Act may be called The Drugs (Appellate Board) Rules 1976.
2. They shall come into force at once.
2. THE APPELLATE BOARD (Past Papers)
1. The Appellate Board shall consist of the following members:
a. Secretary, Health Division, Government of Pakistan, who shall
be its ex-officio Chairman.
b. Secretary, Health Department, Government of the Punjab, ex-
officio or his representative, rank of an officer in BPS 19, who is
an expert in machine, pharmacology or pharmacy.
c. Secretary, Health Department, Government of Sindh, ex-officio
or his representative, rank of an officer in BPS 19, who is an
expert in machine, pharmacology or pharmacy.
d. Secretary, Health Department, Government of Baluchistan, ex-
officio or his representative, rank of an officer in BPS 19, who is
an expert in machine, pharmacology or pharmacy.
e. Secretary, Health Department, Government of the North-West
Frontier Province, ex-officio or his representative, rank of an
officer in BPS 19, who is an expert in machine, pharmacology
or pharmacy.
f. One Professor of medicine, to be nominated by the Federal
Government.
g. One Professor of Pharmacology, pharmacology or medicine to
be nominated by the Federal Government.
h. One representative of the Law Division, Government of
Pakistan.
i. Chairman, Quality Control Authority, Health Division,
Government of Pakistan, who shall be its ex-officio Secretary.
j. One representative of the Ministry of Law and Parliamentary
Affairs, Government of Pakistan.
k. Chief Cost Accounts Officer of the Ministry of Finance.
40

Chapter 4.2 – The Drugs Appellate Board Rules 1976
2. The members, other than ex-officio members, of the Appellate Board
shall hold office for a period of 3 years and shall be eligible for
renominations.
3. The Appellate Board shall meet as and when required to perform its
functions.
4. The Appellate Board shall have powers to appoint a Committee of
Experts for detailed investigation of any matter and report to the
Board.
5. No act or proceeding of the Appellate Board shall be invalid merely
on the ground of the existence of any vacancy in, or any defect in the
constitution of the Board.
3. POWERS OF THE APPELLATE BOARD
 The members of the Appellate Board shall exercise all the powers of
an Inspector without restriction as to area, and such other powers as
may be necessary to perform their functions.
4. PROCEDURE OF APPEAL
1. Any person aggrieved by a decision of the Registration Board, the
Central Licensing Board may, within 60 days of receipt of such
decision, submit an appeal to the Appellate Board.
2. An application for appeal shall be in triplicate and be accompanied by
a copy of the decision appealed against and shall contain all material
statements and arguments by the appellant and a fee of 1000 rupees
for each application.
3. The Appellate Board shall transmit a copy of the application for
appeal to the Registration Board or the Central Licensing Board
against whose decision the appeal has been made and such Board
shall on demand, produce before the Appellate Board the record of
the case leading to the decision.
4. The Appellate Board shall, after giving the appellant an opportunity
of being heard, pass such orders as it thinks fit and they shall be final.
5. REVISION
 The Appellate Board may, of its own motion at any time, call for the
record of any case for the purpose of satisfying itself as to the
correctness, legality or propriety of such order and may pass such
order in relation thereto as it thinks fit.
41

Chapter 4.3 – Punjab Drug Rules 2007
PUNJAB DRUG RULES 2007
CHAPTER I (PRELIMINARY)
1. These rules may be cited as the Punjab Drugs Rules, 2007.
2. These, except application of the Schedule G on the existing licenses,
shall come into force at once.
3. The Schedule G, for the existing licenses, shall come into force after
ten years from the date of issuance of this notification.
2. DEFINITIONS
1. Medical store – means premises where drugs excluding the drugs
specified in the Schedule G are stored, sold or offered for sale.
2. Narcotic, psychotropic or controlled drug – mean a drug specified in
the Schedule B or the Schedule D.
3. Pharmacy – means premises where drugs are stored, sold,
compounded, dispensed or prepared on prescription or distributed in
case of authorized agent of manufacturer, indenter or importer.
CHAPTER III (SALES OF DRUGS)
3. LICENSES UNDER THE RULES
1. The licensing authority may issue a license of a pharmacy or a license
of a medical store.
4. APPLICATION AND FEE FOR LICENSE (Past Papers)
1. A person may apply to the licensing authority for the grant or
renewal of a license in Form 8 (A) or Form 8 (B).
2. The applicant shall deposit the fee for a license in the Head of
Account No. 1252-Health-Other Receipt, at the following rates:
a. 3000 rupees for a license of a pharmacy and 2000 rupees for a
license of a medical store.
b. 2000 rupees for renewal of a license of a pharmacy and 1000
rupees for renewal of a license of a medical store.
42

3. The licensing authority shall issue or renew a license subject to the
conditions prescribed in the Act and the rules.
4. The applicant shall pay 50% of the fee for change of the qualified
person or the duplicate copy of the license.
5. FORMS OF LICENSES TO SELL DRUGS
 The licensing authority shall issue a license of a pharmacy in Form 9
and a license of a medical store in Form 10.
6. SALE AT MORE THAN ONE PLACE
1. If a person desires to sell, store, exhibit for sale or distribute drugs at
more than one place, he shall apply for a separate license in respect
of each place.
2. Provision of this rule shall not apply in case the drugs are properly
stored in a godown, used only for storage of drugs and which meets
the storage conditions and is enlisted along with its complete address
on the license.
7. DURATION OF LICENSES
1. A license issued or renewed under these rules shall unless suspended
or cancelled earlier, remain in force for 2 years from the date of
issue.
2. If a person fails to apply for the renewal of a license within 30 days
after the expiry of the license, his license shall stand cancelled.
3. If a person applies for the renewal of a license within 30 days after
the expiry of the license, his license shall remain enforce until an
order on the application is passed by the licensing authority.
4. The licensing authority shall issue a receipt of an application of a
license or renewal of a license.
5. The licensing authority shall dispose of an application for a license or
renewal of a license within 45 days of the receipt of the application.
6. If the licensing authority fails to dispose of the application within the
specified time, it shall record reasons for its failure.
7. If in the opinion of the licensing authority, it is not expedient in public
interest to grant a license, it may refuse the application.
8. The licensing authority shall not renew a license without an
inspection report of the Inspector.
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8. CONDITIONS FOR ISSUANCE OF LICENSES (Past Papers)
1. The licensing authority shall not issue a license in Form 9 (Pharmacy)
and Form 10 (Medical store) unless:
a. The premises has proper and adequate facility for storage of drugs
and for their protection from direct sunlight, dust or dirt, including
refrigeration facility.
b. The premises is clean, hygienic and in tidy condition.
c. In the case of a license of a pharmacy in which preparation or
compounding of a drug is undertaken, the premises has fulfilled
the requirements contained in the Schedule F.
d. The covered area of the premises of a pharmacy is not less than
140 square feet with minimum breadth of 8 feet in the front and
height of 8 feet and in case of a medical store, 96 square feet with
minimum breadth of 8 feet and height of 8 feet.
e. The applicant is not a convict who has been sentenced for
imprisonment for a period of one year or more or sentenced to
pay fine of 30,000 rupees or more for manufacturing or selling
spurious drugs.
f. A person who is registered under section 24(1)(a) of the Pharmacy
Act 1967 (XI of 1967) has agreed to personally supervise the sale
of drugs for license in Form 9 (pharmacy) and a person who is
registered under section 24(1)(a) & (b) of the said Act has agreed
to supervise sale of drugs for license in Form 10 (medical store).
2. The licensing authority shall not issue a license without inspection
report by a committee comprising of Secretary of the District Board
or the Area Drugs Inspector.
9. CONDITIONS OF LICENSES (Past Papers)
1. The licensing authority shall issue a license in Form 9 or Form 10
subject to the conditions stated in the license and to the following
general conditions:
a. In the case of a pharmacy, the person shall display the word
“Pharmacy” outside wall of the pharmacy in white writing on a
green colored signboard and in the case of a medical store, the
person shall display the words “Medical Store” in white writing on
a blue colored signboard.
44

b. A person who is registered under Pharmacy Act 1967 shall
personally supervise the sale of drugs under license in Form 9
(Pharmacy) and likewise supervision of drug sales at medical store
should be done by person registered for medical store.
c. The supply of a drug shall be recorded suitably and the records,
the bills or the counterfoils shall be preserved for a period of 3
years from the date of the sale.
d. A drug specified in the Schedules B and D and a preparation
containing such drug shall not be sold except with prescription of
a registered medical practitioner; a prescription may be dispensed
with in case of an emergency (recorded in writing in the register);
and no such prescription shall be required for sale of the drug to a
registered medical practitioner, a hospital dispensary or any other
institution.
e. A licensee of a medical store shall not sell or store a drug
mentioned in the Schedule G.
f. The sale of a drug specified in the Schedules B and D shall be
recorded at the time of supply in a register specially maintained
for the purpose and the serial number of the entry in the register
shall be entered in the prescription, and the following particulars
shall be entered in the register:
i. S. No.
ii. Date of Sale.
iii. Name of the prescriber.
iv. Name of the patient.
v. Name of the drug.
vi. Name of the manufacturer.
vii. Quantity sold.
viii. Batch No.
ix. Signature of the qualified person.
x. Quantity purchased and balance.
2. For the purpose of this rule, a prescription shall:
a. Be in writing and be signed by the person giving it with his usual
signature and be dated by him.
b. Specify the name and address of the person for whose treatment
it is given.
45

c. Indicate the total quantity of the drug to be supplied and dose to
be taken.
3. An invoice or a bill for the purchase of a drug shall be preserved for a
period of at least 3 years.
4. A manufacturer, importer or the seller of a drug shall sell the drug
only to a holder of a valid drug sale license or to a registered medical
practitioner and shall issue an invoice and warranty at the time of
sale of the drug.
5. In case of sale of a drug to a registered medical practitioner, the
manufacturer, importer or seller of a drug shall send a copy of the
invoice and warranty to the Inspector.
6. A registered medical practitioner or a Doctor of Veterinary Medicine
is exempted from the requirement of a drug sale license, if:
a. The drug is for his patients.
b. The record of a drug specified in the Schedules B and D is
maintained as prescribed under this rule.
7. The invoice and warranty shall bear the full name and address of the
purchaser and shall be signed by the warrantor clearly indicating his
name and shall be dated.
8. The manufacturer, importer or seller of a drug shall maintain record
of purchase or sale of a drug and shall preserve the record for a at
least three years containing the following particulars:
a. The date of purchase or sale.
b. The name and address of the concern from which the drug is
purchased or the concern to whom the drug is sold.
c. The name of the drug, its batch number, the date of its expiry and
the quantity of the drug.
d. The name of the manufacturer.
9. Except as otherwise provided in these rules, a record required to be
maintained under these rules shall be preserved for a period of 3
years from the date of the last entry.
10.The licensee shall produce for inspection by an Inspector on demand
a register or record maintained under these rules and shall supply to
the Inspector such information as the Inspector may require.
11.A substance specified in the Schedule E and that fall under the list of
poisons and the drug specified in the Schedule B shall be stored in:
a. In a part of the promises to which customers do not have access.
46

b. In a locked almirah, cupboard or drawer, reserved solely for the
storage of the substance or the drug.
12.A substance that falls under the list of poisons in the Schedule E shall
be stored in a container, impervious to the poison, and sufficiently
strong to prevent leakage arising from the ordinary risks of handling
and transport.
13.A substance that fall in the list of poisons under the Schedule E when
compounded and dispensed shall be labeled with the word “Poison”.
SCHEDULE A
 Form 1
Monthly report from inspector
Details of violations in respect of drugs
 Form 2
Progress report for the month of --------
 Form 3
Order under The Drugs Act, 1976 regarding person not to dispose
of stock in his possession.
 Form 4
Intimation of purpose to person from whom the sample is taken.
 Form 5
Receipt for stock of drug and other materials seized under the
Drugs Act, 1976.
 Form 6
Memorandum to Government Analyst
 Form 7
Report of Test/Analysis by Government Analyst, Punjab
 Form 8 (A)
Application for the license to sell, store and exhibit for sale and
distribute drugs by way of pharmacy.
 Form 8 (B)
Application for the license to sell, store, exhibit for sale and to
distribute drugs excluding the drugs specified in Schedule “G” by
way of Medical Store.
 Form 9
License to sell drugs in a Pharmacy.
 Form 10
License to sell drugs in a Medical Store.
47

SCHEDULE B (Past Papers)
 Narcotics psychotropic, Anti-depressant and other controlled drugs.
SCHEDULE C
 Scheme to examine a drug.
SCHEDULE D
 To be sold by a retailer strictly on the prescription of registered medical
practitioner.
 Adrenocorticotrophic hormone (ACTH), Androgenic anabolic, Estrogenic,
and Pregestational substance, Benzeestrol, derivatives of stilbene,
dibenzyl or naphthalene with estrogenic activity, their esters, steroids
compound with androgenic or anabolic estrogenic progress to the
activity and their esters.
 Antibiotics specified, their salts, derivatives and salts of their derivatives.
 Antihistamine substance, their salts and derivatives salts of their
derivatives.
SCHEDULE E (Past Papers)
 Percentage of poison content below which the substance or its
preparation is exempted from the provision of rule
SCHEDULE F
MINIMUM REQUIREMENTS FOR A PHARMACY (Past Papers)
1. ENTRANCE
 The front of a Pharmacy shall be an inscription “Pharmacy”.
2. PREMISES
 The premises of a pharmacy shall be separated from room for private
use. The premises shall be built dry, well-lit and ventilated and shall
of sufficient dimensions to allow the goods in stock, especially drugs
and poison to be kept in a clearly visible and appropriate manner.
 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 and cracks.
 A Pharmacy shall be provided with good quality of water. The
dispensing department shall be separated by a barrier to prevent the
entry of public.
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3. FURNITURE AND APPARATUS
 The furniture and apparatus of the Pharmacy shall be adopted to the
uses for which they are intended and correspond to the size 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. Every container shall bear label
appropriate size, easily readable, with names of medicaments as
given in 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, laminated or plastics etc.
 The containers of concentrated solutions shall bear special label 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 masking of official preparation and
prescriptions:
Apparatus:
 Balances with dispensing sensitivity of 30 mg,
 Balances Counter, capacity 3 kg, sensitivity 1 gm.
 Beakers lipped, assorted sizes.
 Evaporating dishes, porcelain.
 Filter papers, Funnels, Glasses.
 Litmus papers, blue and red.
 Measure glasses cylindrical 10ml, 25ml, 100ml and 500ml.
 Mortar and pestle glass.
 Ointment slab, porcelain, Ointment pot with Bakelite.
 Pipettes graduated, 2ml, 5ml and 10 ml.
 Rubber stamps and pad, scissors, spatula.
 Spirit lamp or gas burner.
 Glass stirring rods, Thermometers, 0 to 2000
C.
 Tripod stand, Watch glasses, Water bath.
 Water distillation still in case eye drops are prepared.
 Weight metric, 1mg to 100mg.
 Wire gauze, Pill finisher, Boxwood.
 Pills Machine, Pill box and suppository mould.
 Ring stand (retort) iron, complete with rings.
49

Books:
 The United State Pharmacopoeia 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
SCHEDULE G
 Drugs not to be sold/stored by licensee in Form 10.
1. Anti-leprosy.
2. Immunological products, Vaccines, Sera / Anti Sera.
3. Products Related with Malignant Diseases and
Immunosuppression.
4. Drugs of Anesthesia and Inhalation Anesthetics.
5. Antibiotics.
6. Inotropic.
7. Injection Prostaglandins.
8. Alpha Blocker.
9. Biotechnological Products.
10.Narcotics, Psychotropic / Tri Cyclic Anti-Depressant.
11.Antiviral.
12.Thrombolytic Enzymes.
13.Product Used in Dialysis.
14.Creams and aerosols Steroidal Preparations.
15.Hormones.
50

Chapter 4.4 – The Drugs Advertisement Rules
THE DRUGS ADVERTISEMENT RULES
1. CONDITIONS FOR ADVERTISING (Past Papers)
1. The Federal Government may, after seeking advice of the Committee
on Advertising, allow the advertisement of a drug, or any substance
or a remedy as specified in Schedule D-1 or a treatment, approve the
contents of such advertisement and specify conditions subject to
which such advertisement shall be made:
a. An application for advertisement of any drug, substance,
remedy, treatment or offer of treatment for any disease shall
be made in Form-8, addressed to the Secretary of the
Commissioner on Advertising and there shall be made a
separate application for each advertisement.
b. An application shall be accompanied by the proper fee
specified in Schedule F.
c. The approval of the advertisement shall be valid for a period of
two years only.
2. A drug or any substance may be advertised to the medical,
pharmaceutical and allied professions, without referring to the
Federal Government, through medical representatives or through
professional journals and publication which are meant for circulation
exclusively amongst the members of the medical, pharmaceutical and
allied professions ·
3. Advertisements shall be subjected to the following conditions,
namely:
a. All claims shall be made in accordance with these approved for
registration of that drug.
b. Where the usual information on indications and dosage is
provided, that advertisement material shall contain
information on contra-indications, side effects and other
necessary precautions as may be applicable.
4. A drug or any substance may be advertised through Press without
reference to the Federal Government if it is merely intended to
inform the public of the availability or the price of such drug or any
substance subject to the condition that the Federal Government may
51

prohibit such advertisement if, in its opinion, the public interest so
requires.
5. A drug or any substance may be advertised to the medical,
pharmaceutical and allied professions through a documentary film.
6. No advertisement under this rule shall contain any direct or indirect
comparison in any way with any other drug or substance or remedy
for any disease for the purpose of attracting customers or with a view
to discredit other such product.
7. Advertisement material shall be presented with courtesy and good
taste and words and phrases implying urgency, uniqueness or such
expressions which are absolute in character, such as "the most
potent", "the most rapid", "the most efficacious", or which make
exaggerated claims or to general claims, such as "effective in all
cases" or "effective against all complaints" or superlatives shall be
avoided.
8. Advertisement of a drug or any substance shall include such
information or any risks and other precautions as may be necessary
for the protection of public health, and in the case of drug also its
maximum retail price fixed under Drugs Act 1976.
9. No drug or any other substance shall be advertised in a manner
which encourages self-medication or use to the extent that it
endangers health.
10.No drug or any remedy, treatment or after treatment of any disease
specified in Schedule 'E' shall be advertised.
11.Reminder publications for the medical, pharmaceutical and allied
professions shall include the name of the drug and its exact
composition, the price, the name and address of the manufacturer
and a statement to the effect that "Full information is available on
request".
2. SAMPLING OF DRUGS
 Samples of drugs may be provided to the physicians or dentists or
Pharmacists or Veterinarians or a medical institution in a reasonable
quantity and in reduced packings marked with the words "Physicians
Sample Not for Sale".
3. EXPENDITURE ON ADVERTISEMENT
 No person shall spend more than 5% of his turnover on
52

advertisement, sampling and other promotional activities in respect
of drugs.
4. SUBSTANCES REQUIRED TO BE PRESCRIBED
 Any substance or a mixture of substances offered for sale which is
injurious, or likely to become hazardous, to the health of a person
shall be considered as a substance for the purpose of the Ordinance.
5. RETAILER'S DISCOUNT
 The retailers discount shall be 15% of the maximum retail price.
53

Chapter 4.5 – The Drugs Labeling and Packing Rules 1986
THE DRUGS LABELING AND
PACKING RULES 1986
1. This Act may be called The Drugs Labeling and Packing Rules, 1986.
2. They shall come into force on the expiration of the period of one year
beginning with their publication in the official Gazette.
2. DEFINITIONS
1. International non‐proprietary name – means the name of drug as
recommended by the World Health Organization or such other name
as may be notified by the Federal Government in the official gazette.
2. Pharmacopeial – means a publication mentioned in drugs Act, 1976.
3. Pharmacopeial name – means the name of a drug as mentioned in
the pharmacopoeia.
4. Schedule – means a schedule to these rules.
5. Registered Medical Practitioners – means a Medical Practitioner
registered or provincially registered under the medical and Dental
Council Ordinance, 1962.
3. MANNER OF LABELING
1. The following particulars shall appear either in print or in writing in
inedible ink in a clear manner on a label of the innermost container
of drug and also on the in which such container is packed namely:
a. The registered name of the drug.
b. If the registered name is a proprietary name, then immediately
following the registered name, the international non‐
proprietary name, and if no such non‐proprietary name is
known the Pharmacopeial name or any other name, if any,
approved by the registration board for this purpose in clear
manner.
c. The international non‐proprietary name or the pharmacopoeia
name or the generic name, and if no such name is known the
chemical name of each active ingredient of a drug with weight.
54

4. LABELLING OF DRUGS FOR INTERNAL USE
1. The label of container of a drug meant for internal use, except a drug
contained in a strip or foil or blister or collapsible tube shall in
additions to the particulars required to be given under these rules
bear in a clear manner:
a. If it contains a substance specified in the schedule the words
“to be sold on prescription of a registered medical practitioner
only”.
b. If it contains 3% by volume and alcohol a statement giving the
quantity of alcohol in terms of average percentage by volume
of absolute alcohol in the finished product.
5. LABELLING OF DRUGS OF EXTERNAL USE ONLY (Past Papers)
1. The label of a container of ointment, cream, liniment, lotion,
antiseptic or any drug for external application shall in addition to the
particular required to be given under these rules bear in a clear
manner:
a. The words “For external use only“.
6. LABELLING OF PHYSICIAN’S SAMPLE
 The label of a container of every drug intended for distribution to the
medical profession as free sample shall in addition to the particulars
required to be given under these rules bear the words “Physician
sample not for Sale” which shall be over printed or stamped.
7. LABELLING OF DRUGS FOR GOVERNMENT SUPPLY (Past Papers)
 The label of a container of every drug intended for the supply to any
Government agency including an autonomous body or a semi‐
Government Agency shall while complying with the other labelling
requirements of these rules, bear the words or mark reading
“Government supply” or such other words or mark as may be
required by the concerned agency.
8. Labelling of Drugs for Veterinary use
 The label of a container of drug for veterinary use shall bear in a clear
manner the words “ For veterinary use only”.
55

9. OUTER TRANSPARENT WRAPPER NOT TO REQUIRE LABELING
 Nothing in these rules shall be deemed to require the labeling of any
transport cover, wrapper, case, or other covering used solely for the
purpose of packing, transport or delivery of a drug.
10.LABELLING OF NON‐STERILE SURGICAL LIGATURE AND SUTURE
 Every container of and every wrapper enclosing a surgical ligature or
suture, other than a ligature or suture certified to be sterile and fit
for surgical use without further sterilization shall bear a label or
which shall be printed or written in a clear manner in indelible red ink
the word “Non‐Sterile Surgical ligature/suture, Not to be used for
operations upon human body unless properly sterilized”.
11.USE OF LETTERS TO INDICATE SPECIFICATIONS
 Subject to these rules the letters “P.P”, “Ph.I”, “Eur.Ph”, “B.P”,
“B.P.C” and “U.S.N.F” shall be printed or written in indelible ink on
the label to indicate so that the drug is manufactured in accordance
with the specifications set out in the Pakistan Pharmacopoeia,
international Pharmacopoeia, European Pharmacopoeia, United
States Pharmacopoeia, British Pharmacopoeia, British
Pharmaceuticals Codex or the United States National Formulary, as
the case may be.
12. PACKING OF FINISHED DRUGS
 Each finished drugs ready for use shall be packed in containers
intended for retail sale to a hospital dispensary, clinic, or any other
such institutions.
13.LABELLING OF DRUGS FOR EXPORT (Past Papers)
1. Noting contained in these rules shall apply to a drug manufactured for
export the label on the package or container of which has been
adopted to meet the specific requirements of the country to which
the drug is exported. The label on the package or container of such
drug shall bear the following particulars at a visible place on the
innermost container in which the container is packed namely:
a. The Name of the drug.
b. The name and principle place of business of the manufacturer.
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c. Batch number of the drug date of manufacture and the date of
expiry.
14.EXEMPTION (Past Papers)
 These rules should not be applicable in respect of a drug made up
ready for treatment, whether after or without dilution and is supplied
by a person licensed to sell drugs on the prescription a registered
medical practitioner.
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Chapter 4.6 – DRAP Act 2012
DRAP ACT 2012
 Drug Regulatory Authority of Pakistan Act, 2012.
 Extends to whole of Pakistan.
 Shall come into force at once.
1. Alternative Medicine – means a product exclusively in Homeopathy,
unani, Ayurvedic, Biochemical, Chinese or other traditional systems
of medicine.
2. Appellate Board – means an Appellate Board for the disposal of
appeals against the decisions of the licensing board or registration
board or pricing committee.
3. Biologicals – means biological drugs as defined in Schedule I.
4. Drug – means drug as defined in Schedule I.
5. CEO – means the Chief Executive Officer of the authority.
6. Health and OTC Products – Include probiotics and disinfectant,
nutritional products, food supplements, baby milk and foods,
medicated cosmetics, medicated soaps and medicated shampoos.
7. Medical Device – means medical devices as defined in Schedule I.
8. Medicated Cosmetics – means cosmetics containing drugs as defined
in Schedule I.
9. Pharmaceutical Field – means regulation, manufacturing, quality
control, quality assurance, research, academia, import, export, and
pharmacy services in drugs.
10.Pharmacy Services – means services rendered by a pharmacist in
pharmaceutical care, selection, posology, counseling, dispensing, use,
administration, prescription monitoring, pharmacoepidemiology,
therapeutic goods information and poison control,
pharmacovigilance, Pharmacoeconomics, storage, sales,
procurement, forecasting, supply chain management, distribution,
drug utilization evaluation, drug utilization review, formulary based
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drug utilization and managing therapeutic goods at all levels including
pharmacy, clinic, medical store, hospital or medical institution.
11.Therapeutic Goods – Includes drugs or alternative medicine or
medical devices or biologicals or other related products as may be
notified by the Authority.
CHAPTER II (AUTHORITY AND BOARD)
3. ESTABLISHMENT OF AUTHORITY
1. After the commencement of this Act, the Federal Government shall
establish an Authority to be known as the Drug Regulatory Authority
of Pakistan.
2. The Authority shall be an individual body having common seal and
shall work for the purposes of this Act.
3. The Authority shall be an autonomous body under the administrative
control of the Federal Government with its headquarters at
Islamabad.
4. The Authority may set up its sub-offices provincial capitals and such
other places, as it may consider necessary from time to time.
5. The common seal / stamp of the authority shall be kept under
custody of CEO.
4. COMPOSITION OF AUTHORITY (Past Papers)
1. Authority shall consist of full time CEO and 13 directors who shall be
designated as:
i. Director Pharmaceutical Evaluations and Registration –
Incharge, Responsible for evaluation, assessment and
registration of pharmaceuticals drugs for human beings,
animals and to perform other functions connected within and
assigned by the Board.
ii. Director Drug Licensing – Incharge, Responsible for licensing of
the drugs manufacturing facilities.
iii. Director Quality Assurance and Laboratory testing – Incharge,
Responsible for enforcement of current Good Manufacturing
Practices under the Act, and for testing or research of drugs.
iv. Director Medical Devices and Medicated Cosmetics –
Incharge, Responsible for the assessment, enlistment or
registration of medical devices and medicated cosmetics,
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medicated shampoos and medicated soaps for human beings,
animals.
v. Director Biological Drugs – Incharge, Responsible for the
evaluation, assessment, registration and licensing of Biologicals
for human beings, animals.
vi. Director Controlled Drugs – Incharge, Responsible for
regulation and allocation of quota of narcotic drugs,
psychotropic substances and precursor chemicals.
vii. Director Pharmacy Services – Incharge, Responsible for the
development and promotion of pharmacy services.
viii. Director Health with OTC Products (non-drugs) – Incharge,
Responsible for the assessment, licensing and registration of
Alternative Medicines such as Ayurvedic, Chinese, Unani and
Homeopathy, enlistment or registration of nutritional products
and food supplements for human beings, animals.
ix. Director Costing and Pricing – Incharge, Responsible for the
costing and pricing of therapeutic goods.
x. Director Budget and Accounts – Incharge, Responsible for
budgetary and financial aspects of the Authority and other
daily accounting matters.
xi. Director Administration, Human Resource and Logistics –
Incharge, Responsible for administration, recruitment,
appointment, capacity building and development for the
Authority.
xii. Director Legal Affairs – Incharge, Responsible for legal aspects
of the Authority and other matters connected with Drug Court.
xiii. Director Management Information Services – Incharge,
Responsible for development of automation of functions using
information technology for the Authority.
2. The Federal Government, on the recommendations of the Board may
increase or decrease the number of Divisions or Director.
5. CHIEF EXECUTIVE OFFICER (Past Papers)
1. The Federal Government may, on the recommendations of the Board
appoint a person as Chief Executive Officer who:
i. Has a post graduate degree in Pharmacy or medicine with an
age not less than 45 years or more than 56 years, with a
minimum of twenty years’ experience in management or
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pharmaceutical field or regulatory affairs.
ii. The tenure of appointment of CEO shall be for a period of
three years, which is extendable for one year only.
iii. The CEO shall exercise general control and supervision over the
affairs of the Authority.
2. The CEO shall perform duties functions as assigned by Act or by the
Board and shall:
i. keep in custody the records and stamp of the Authority
ii. Submit workplan and budget estimates of the Authority for
approval.
3. The CEO shall also have the power to:
i. Supervise the activities of programs for training, research,
institutional consultancies, and other services.
ii. Authorize expenditure in accordance with the rules and
regulations.
iii. Re-appropriate funds within the approved budget.
iv. Issue notices of meetings of the Board and Appellate Board
and to maintain proper record of the minutes and proceedings.
v. Perform any other duty assigned to him by the Board.
4. The CEO shall not allow any expenditure which is not approved in the
budget.
5. The CEO may submit his resignation under his own hand.
6. In case of occurrence of vacancy of CEO the Federal Government is
authorized to appoint any person deem fit.
6. MEETING OF THE AUTHORITY
1. Authority shall regulate the procedure for its meetings.
2. CEO will conduct the meetings of the Authority at any time on his
own or as directed by the Policy Board.
7. POWERS AND FUNCTIONS OF AUTHORITY (Past Papers)
1. Administer the laws specified in the Schedule-VI that apply to Federal
Government and advise the Provincial Governments for the laws that
are applicable to the Provinces.
2. Monitor the enforcement of laws and collect relevant data and
information.
3. Issue guidelines and monitor the enforcement of:
i. Licensing of the manufacture of therapeutic goods
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ii. Registration of therapeutic goods.
iii. Regulation for the advertisement.
iv. Drug specifications and laboratory practices.
v. Prosecution and appeals.
vi. Regulation and allocation of quota.
vii. Regulation for pricing and mechanism for fixation of prices.
viii. Determining standards for biological manufacturing and
testing.
ix. Implementation of internationally recognized standards.
x. Regulation, enforcement and monitoring of advertisement rule
and ban on false advertisement.
xi. Manufacturing of active pharmaceutical ingredients in all its
forms.
xii. Use of central research fund.
4. Coordinate and engage with other organizations, Provincial Govts.
5. Facilitate advancement and up gradation of the sector.
6. Coordinate at policy level and provide policy guidance.
7. Facilitate procurement, implementation of foreign aided assistance.
8. Development and promotion of pharmacy services.
9. Awareness campaigns regarding prevention of diseases, etc.
10.Issue guidelines and monitor proceedings and funding and accounts.
11.Advise the Federal Govt. on issues related to therapeutic goods.
12.Appoint necessary employees, consultants and experts.
13.Prescribe rules for seniority, promotion, code of conduct and terms
and condition of service of its employees.
14.levy charges or fees as prescribed by the Authority.
15.Contract for the supply of materials or for the execution of works.
16.Prepare annual budget to be approved by the Board.
17.Monitor and regulate the marketing practices.
18.Develop working manuals, guidelines, materials and procedures.
19.Prescribe, regulate or implement measures and standards.
20.Develop, issue, adopt, and enforce the standards.
21.Perform licensing, registration, pricing and appellate functions.
22.Coordinate with provincial govts. for smooth implementation of laws.
23.Develop SOPs, manuals and guidelines.
24.Establish system of cost recovery.
25.Perform and carry out any other act necessary.
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8. POLICY BOARD
1. General direction, administration and monitoring of the Authority
shall vest in the Policy Board which shall consist of 15 members,
namely:
a. Secretary of the concerned Division – Chairperson
b. CEO – member Representative of Ministry of Law and Justice –
member
c. Secretary of the concerned Department, Govt. of the
Balochistan – member
d. Secretary of the concerned Department, Govt. of the Sindh –
member
e. Secretary of the concerned Department, Member Govt. of the
Khyber Pakhtunkhwa – member
f. Secretary of the concerned Department, Member Govt. of the
Punjab – member
g. Secretary of the concerned Department; Member Govt. of the
Gilgit-Baltistan – member
h. Representative from Federally Administered Member Tribal
Area – member
i. Six experts from the public and private sector from different
specialties – member
2. The CEO shall also be the Secretary of the Board.
3. Six expert members having specialty in the fields of:
Drug manufacturing
Quality control
Drug regulation
Public health
Pharmacy services
Health finance
Health economics
Pharmacology
4. No act or proceeding of the Board shall be invalid by reason only if
the existence of a vacancy in the constitution of the Board.
5. the Board may increase or decrease the number of its members and
prescribe the qualifications and procedure for their appointment.
9. MEETING OF POLICY BOARD
1. Secretary will conduct the meetings of the Board with approval of
chairperson.
2. The meetings of the Board shall be held at twice a year or more as
and when required.
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3. In absence of chairperson, secretary will preside, in absence of
secretary the quorum will elect a member to preside meeting.
4. All decisions taken by the Board shall be recorded in writing.
5. The Board meeting shall be called by giving an advance notice of at
least seven days.
10.FUNCTIONS OF BOARD (Past Papers)
1. Frame policy, provide guidelines based on global and regional trends
to the Authority, Monitor the implementation and performance of the
guidelines and of the functions of the Authority ensuring good
governance and accountability.
2. Monitor and supervise all the functions of the Authority.
3. Approve the Budget of the Authority.
4. Determine all fees and levies.
11. INTEGRATION OF DRUG CONTROL ADMINISTRATION
1. DCA offices and laboratories.
2. Moveable and immoveable properties.
3. Debts and obligations.
4. Suits and litigations.
5. Employees have to choose Federal Government or Authority.
12. CONFLICT OF INTEREST
1. No person will be appointed as CEO, Director, consultant, advisor,
officer or employee of Authority if he or she has any financial or
professional conflict of interest.
2. Kinship and owners of concerns dealing with therapeutic goods will
not be entertained as members.
CHAPTER III (FUND, BUDGET AND ACCOUNTS)
13.FUNDS
 Grants of Federal Government and international agencies, levy
charges, fees, investment, loans etc.
14.BUDGET
 Annual budget to approve from Board and sent to Ministry of Finance
for allocation.
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15. ACCOUNTING AND AUDIT
 Audit of accounts and send copy to Federal Government with its
comments.
CHAPTER IV (RULES AND REGULATIONS)
16. POWER TO MAKE RULES
 The Authority, with the approval of Federal Government, may make
Rules for carrying out the purposes of this Act.
17.POWER TO MAKE REGULATIONS
 The Authority, with the approval of Board, may make Regulations for
carrying out of its functions under this Act.
CHAPTER V (MISCELLANEOUS)
 Submission of annual reports and returns.
 Power to call for information.
 Offences, penalties etc.
 Offences by companies etc.
 Cognizance of offences.
 Complaints.
 Confidential information.
 Act not to override other laws.
 Recovery of arrears.
 Indemnity.
 Power to amend Schedule.
 Removal of difficulties.
 Employment under Authority – Federal Government.
 Co-operation with international organizations.
 Repeal and Savings.
 Policy Directive of Federal Government.
 Winding up of Authority.
SCHEDULES
 Schedule I – Biologicals, Drugs, Medical Devices and Medicated
Cosmetics.
 Schedule II – Prohibitions, Control of advertisement, Control of printing
labeling.
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 Schedule III – Offences.
 Schedule IV – Cognizance of offences.
 Schedule V – Powers of Inspectors.
 Schedule VI – The Drugs Act, 1976.
BIOLOGICALS (SCHEDULE I) (Past Papers)
 Biological drugs produced by biological systems and which require
standardization by biological assays according to the relevant and
updated recommendations and includes:
Blood products
Immunological products
In vivo diagnostics
Antigens, cytokines
Vaccines
DRUG (SCHEDULE I) (Past Papers)
 Drug is defined as:
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 er the restoration, correction, or
modification of organic functions in human beings or animals,
including substance used or prepared for use in accordance with
the Ayurvedic, Unani, Homoeopathic, Chinese or biochemic
system of treatment except those substances and in accordance
with medical conditions may be Prescribed.
MEDICAL DEVICES (SCHEDULE I) (Past Papers)
 Medical devices include:
Instruments, medical equipment, implants, disposables and
software, used mainly for the purpose of diagnosis, monitoring
and treatment of diseases.
Any other item which the Federal Government may, by
notification in the official Gazette, declare as medical device.
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Chapter 5 – The Pharmacy Act 1967
THE PHARMACY ACT 1967
 Pharmacy Act 1967.
 Shall come into force at once.
2. DEFINITIONS
 Approved – Approval of examinations and course of study.
 Council – Establishment of Pharmacy council.
 PPA – Pakistan Pharmacist Association.
 Pharmacist – Preparation and maintenance of registers.
3. ESTABLISHMENT OF PHARMACY COUNCILS
1. Within one year after commencement of this act.
a. Federal Govt. → Notification → Pharmacy Council of Pakistan.
b. Provincial Govt. → Notification → Provincial Pharmacy Council.
2. Each established council is individual body having common seal with
power.
4. COMPOSITION OF CENTRAL COUNCIL (Past Papers)
1. The central council consists of the following members:
a. Director General of Health Department, Govt. of Pakistan, ex-
officio will be the president of council unless Federal govt.
appoints any other officer as president of council.
b. 8 persons, nominated by Federal Government:
i. One person from each Province
ii. One; a teacher of Pharmaceutics
iii. One; a teacher of Pharmaceutical Chemistry
iv. One person from PPA central
v. Drug controller, Pakistan.
2. The federal government by notification in official gazette may
increase or decrease the number of members. In case of decrease
office continuance should not be affected.
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5. COMPOSITION OF PROVINCIAL COUNCIL (Past Papers)
1. The provincial council consists of the following members:
a. Secretary to the Provincial Govt. of Pakistan, ex-officio will be
the president of council unless Provincial govt. appoints any
other officer as president of respective council.
b. 5 persons, nominated by Provincial Government:
i. One person shall be officer of Provincial government
ii. One person from PPA provincial.
2. The provincial government by notification in official gazette may
increase or decrease the number of members. In case of decrease
office continuance should not be effected.
6. DISQUALIFICATION FOR MEMBERSHIP
 Person other than Professor of Medical/Pharmacy institute or officer
nominated by government will not be eligible if he is not a
pharmacist.
7. PUBLICATION OF NAMES
 Federal government or Provincial government shall announce the
title and names of members in official gazette.
8. TERMS OF OFFICE
1. A member other than ex-officio shall hold office for 3 years and will
be eligible for renomination.
2. If majority of members are satisfied that a member is negligent in his
duties, guilty of unprofessional conduct or is not compelled to
perform his duties will be removed by notification in official gazette.
Seat of member shall become vacant.
9. FILLING OF CASUAL VACANCY (Past Papers)
 Vacancy shall be filled within 6 months by nominating another person
in his place in same manner.
10.VACANCY, NOT TO INVALIDATE PROCEEDINGS OF COUNCIL
 No act or proceeding of council shall be invalid merely on basis of
existence of any vacancy or in any defect in composition of council.
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11.ELECTION OF VICE PRESIDENT (Past Papers)
1. Council shall select one of its member every year as vice president,
and vice president shall hold the office for 1 year and will continue
working even after expiry of post unless new member is elected.
2. VP will perform his assigned functions and will also perform functions
of president in his absence.
12.COMMITTEES OF A COUNCIL
1. Council will make such a committee that is deem fit for purpose of
advising and assisting in performance of its functions.
2. Committee may co-opt person as its members whose advice is
important for efficiency.
13.MEETINGS OF A COUNCIL (Past Papers)
1. Meetings will held on date, time, place laid down by bye-laws of
council, if bye-laws are not yet made than president will conduct a
meeting at such date, time, place in manner he considers best.
2. In absence of president, VP shall preside and in absence of VP,
members present shall elect one amongst them to preside.
3. The quorum (minimum number of members required to elect
someone) for a meeting shall be 1/3 of the total members of council.
14.ANNUAL REPORT
 At the end of every year central council shall submit annual report of
proceedings and expenditures to the federal government while
provincial council will submit annual report to provincial government.
15.APPOINTMENT OF SECRETARY, OFFICERS, AND STAFF OF
COUNCIL (Past Papers)
1. With approval of respective government the respective council shall
appoint pharmacists on suitable terms and conditions.
2. Appoint officers and staff as they deem fit.
16.FINANCES
1. Funds of central council is the money placed at its disposal by federal
government.
2. Funds of provincial council is the money placed at its disposal by
provincial government.
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17.FUNCTIONS OF THE CENTRAL COUNCIL (Past Papers)
1. The functions of the central council shall be:
a. Approve examinations in pharmacy.
b. Prescribe subjects for examinations.
c. Approve course of study and practical training.
d. Conditions and procedures for admission of candidate to an
approved examination.
e. Lay down standards of teaching to be maintained by institution.
f. Prescribe the equipment and facilities to be made available to
students.
g. Recognize degree or diploma in pharmacy.
h. Perform inspection of institutes.
i. Any other act and things required to do under this act.
2. Central council will make these regulations by notification in official
gazette with approval of federal government.
18.APPROVAL OF EXAMINATIONS
1. Any institute, authority or provincial council which holds
examinations in pharmacy will take approval from central council for
the purpose of qualifying persons for registration as pharmacists.
2. After inquiry, if central council is satisfied, it shall approve the
examination by notification in official gazette.
19.APPROVAL OF COURSES OF STUDY (Past Papers)
1. Any institute, authority or provincial council which conducts course of
study in pharmacy will take approval from central council for the
purpose of approval of such courses of study for the purpose of
admission to an approved examination.
2. After inquiry, if central council is satisfied, it shall approve the course
of study by notification in official gazette.
20.FURNISHING OF INFORMATION (Past Papers)
1. Every institute, authority which conducts exams or course of study in
pharmacy will furnish to central council time by time:
a. Course of study.
b. Examinations.
c. Ages at which students undergo courses of study.
d. Equipment or facilities provided.
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e. Matters generally pertaining to all these.
21.INSPECTORS (Past Papers)
1. Central council appoints such inspectors for inspection of institutions
as it may consider necessary.
2. Inspectors are authorized in writing by the President of the council.
a. Inspect any institution who holds approved exams and courses.
b. Inspect any institution who has applied for approval of exams and
courses.
3. Inspector shall not interfere in any exam but submit to council.
22.WITHDRAWL OF APPROVAL (Past Papers)
1. Upon a report by inspector, it appears that the course of study or
exams in institution does not continue to be in the conformity with
this act and regulations. Council shall give notice to institution to
explain in writing why the approval of its course of study or exams
should not be withdrawn.
2. Such institution may within 60 days, represent in front of central
council, through provincial government.
3. After considering explanation or any representation, if the central
council think fit, they will declare approval of course of study, exams
or shall stand withdrawn and authority shall approve only when
completed or passed before the date specified.
23. FUNCTIONS OF PROVINCIAL COUNCIL
1. The functions of the provincial council shall be:
a. Prepare and maintain registers of pharmacists and apprentices.
b. Register pharmacists and grant certificate of registration.
c. To conduct examinations for the purpose of registration.
d. Any other act and things required to do under this act.
24.PREPERATION AND MAINTAINANCE OF REGISTERS (Past Papers)
1. Provincial council shall prepare following registers of pharmacists and
apprentices:
a. Register A – Person holding degree in pharmacy from a
recognized university.
b. Register B – Person holding diploma in pharmacy granted by
recognized institute.
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c. Register C – Apprentices in pharmacy.
2. Every register should include the following particulars:
a. Full name
b. Residential address
c. Professional address
d. Father’s name
e. Date and place of birth
f. Nationality
g. Qualifications
h. Registration date
i. Other particulars
required by bye-law.
25.QUALIFICATION FOR REGISTRATION AS A PHARMACIST OR AS
AN APPRENTICE IN PHARMACY
1. Following are qualified for registration as Pharmacists:
a. Person who holds degree in pharmacy conferred by a university or
institution affiliated with central council.
b. Person who holds diploma in pharmacy from a recognized
institution by central council.
c. Person who pass exam in pharmacy held by provincial council.
2. Following can be registered as apprentices:
a. Drug Inspector or Government Analyst appointed under Drug Act
1940.
b. Person certified by a Government Hospital to be a qualified
dispenser or compounder.
c. Person who is student pharmacist of register A.
d. Person who is qualified by Rule 65 of West Pakistan Drug Rules
1958.
3. Following are not eligible to qualify as Pharmacists or Apprentice:
a. Person having unsound mind and stands so declared by court.
b. Person who is convicted by a court of any offense (moral
turpitude).
26.PROCEDURE FOR REGISTRATION (Past Papers)
1. After opening of registration, Provincial council by notification in
official gazette invites applications for registration as pharmacists or
apprentices in pharmacy.
2. Application for registration shall contain particulars specified by
provincial council along with fee prescribed by the bye-laws.
3. Provincial council examines applications, if satisfied direct entry of
name of applicant is made in appropriate register.
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4. If Provincial council rejects application, applicant will be informed in
writing and he may appeal within 60 days of receipt to the provincial
government whose decision will be final.
5. If council sends no rejection letter to applicant it means the
application has been accepted.
27.CERTIFICATE OF REGISTRATION (Past Papers)
1. Provincial council shall issue certificate of registration to the person
who has been registered successfully.
2. Issued certificate has a number and official stamp of the council along
with signatures of President and the Secretary and shall contain the
following:
a. Passport size photograph
b. Full signature
c. Mark of identification
3. One copy of certificate with all the particulars will be kept in official
record of the council.
4. If any person has lost original certificate and needs a duplicate one,
he will pay the same fee paid for the original one.
28.REVOCATION OF CERTIFICATE
1. The provincial council after giving an opportunity to make
representation and of being heard, revoke the certificate of
registration issued to him, if such person:
a. Unsound mind or convicted by a court of any offence.
b. Violates Poison Act 1919, Dangerous Drug Act 1930, Drug Act
1976 or Pharmacy Act 1967.
c. Fails or neglects to respect profession of Pharmacist.
d. Guilty of professional misconduct.
2. The person whose certificate is revoked is given written notice, then
his name will be struck off from the register and registration will be
cancelled.
3. If the person appeals within 30 days to provincial council, the council
will review the decision of revoking certificate and the decision will
be final.
29.EXAMINATION FOR REGISTRATION AS PHARMACIST
1. Exams will be conducted twice a year.
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2. Examination place will be decided by the provincial council.
3. Notice shall be published within 1 week, in 1 English Newspaper and
1 in local language Newspaper.
4. Application for admission to an examination shall have:
a. A fee prescribed by the bye-laws.
b. A good moral character certificate.
c. Other particulars required by the provincial council.
30.QUALIFICATION FOR ADMISSION TO AN EXAMINATION
1. Qualification of applicant for admission to an examinations:
a. Shall not below 17 years of age on the date fixed for exams.
b. Passes Matriculation exam or equivalent with science group.
c. Registered as an apprentice in pharmacy for a period not less than
2 years.
31.PROHIBITION OF PRACTICE WITHOUT REGISTRATION (P. Papers)
1. A person can’t practice unless he is a registered pharmacist and
displays his certificate of registration at his workplace.
2. Whoever employs pharmacist for the purpose of business in
pharmacy shall display pharmacist certificate of registration at his
business place.
3. Anyone who violates sub-section 1 and 2 given above, will be held
punishable either prison for specified terms which may be extended
to 6 months or fine 1000/- Rupees or both.
4. Nothing in sub-section 1 shall apply to:
a. Registered medical practitioner, or authorized person to prescribe
antibiotics and dangerous drugs in allopathic system.
b. Any person who deals in non-poisonous household remedies in
original and unopened containers.
c. Any person who manufactures, sells, distribute unani, ayurvedic,
biochemic and homeopathic drugs.
d. Health and veterinary technician in government hospital or
institution.
e. Foreign pharmacist, who is engaged with the approval of central
council, for the purpose of consultation, advice or instruction.
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32.POWER TO MAKE BYE-LAW (Past Papers)
1. Respective council with the permission of respective government
shall make bye-law for the purpose of this act.
2. Bye-law may provide for the following matters:
a. Procedure for the meetings of the council and its committees.
b. Management of the property of council.
c. Maintenance and audits of the accounts of council.
d. Procedure for election of vice president.
e. Power and duties of president, vice president and other council
members.
f. Terms and Conditions of secretary and other officers and staff of
the council.
g. Fees to be prescribed.
h. Such other matters necessary for council’s efficient performance.
3. Unless the bye-laws are formulated, council president will give
necessary instructions and when the laws will be formulated any such
instructions will be cancelled.
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Chapter 6 – Control of Narcotic Substances Act 1997
CONTROL OF NARCOTIC
SUBSTANCES ACT 1997
1. This Act may be called The Control of Narcotic Substances Act, 1997.
3. It shall come into force at once.
2. DEFINITIONS
1. Addict – means a person physically or mentally dependent on any
narcotic drug or psychotropic substance or a person who habitually
uses narcotic drugs or psychotropic substances.
2. Assets – means any property owned, controlled or belonging to an
accused, whether directly or indirectly, or in the name of his spouse
or relatives or associates whether within or without Pakistan for
which they cannot reasonably account.
3. Cannabis – means:
a. Cannabis resin (charas) that is, the separated resin, whether
crude or purified, obtained from the cannabis plant and also
includes concentrated preparation and resin known as hashish
oil or liquid hashish.
b. The flowering or fruiting tops of the cannabis plant from which
the resin has not been extracted, by whatever name they may
be designated or known.
c. Any mixture with or without neutral materials of any of the
above forms of cannabis or any drink prepared thereform;
4. Coca derivative – means:
a. Crude cocaine, that is any extract of coca leaf which can be
used, directly or indirectly, for the manufacture or production
of cocaine.
b. Ecgonine, that is, levo-ecgonine having all chemical derivatives
of levo-ecgonine including benzoylecgonine from which it can
be recovered.
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c. Cocaine, that is, methyl-benzoyl-levo-ecgonine having its salts.
5. Controlled delivery – means the technique of allowing illicit or
suspect consignments of narcotic drugs, psychotropic substances or
chemical precursors to pass out of, through or into Pakistan, with the
knowledge and under the supervision of the Federal Government
with a view to identifying persons involved in the commission of
offences cognizable under this Act.
6. Conveyance – means a conveyance of any description whatsoever
and includes any aircraft, vehicle, vessel, railways or animal.
7. Freezing – means prohibiting by an order made by the Special Court
or an officer authorized under this Act the transfer, conversion,
disposal or movement of any assets and includes the holding,
controlling, assuming custody or managing any assets in pursuance of
such order and, in the case of assets which are perishable the
disposal thereof.
8. Opium – means:
a. Poppy straw, that is to say, all parts of the poppy plant
(Papaver somniferum or any other species of Papaver) after
moving, other than the seeds.
b. The spontaneously coagulated juice of capsules of poppy which
has not been submitted to any manipulations other than t hose
necessary for packing and transport.
c. Any mixture, with or without natural materials, of any of the
above forms of opium, but does not include any preparation
containing not more than 0.2 percent of morphine;
9. Opium derivative – includes:
a. Medicinal opium, that is, opium which has undergone the
process necessary to adapt it for medicinal use.
b. Prepared opium, that is, any product of opium obtained by any
series of operations designed to transform opium into an
extract suitable for smoking, and the dross or other residue
remaining after opium is smoked.
c. Morphine, that is, the principal alkaloid of opium and its salts.
d. Diacetylmorphine, that is, the semi-synthetic substance, also
known as diamorphine or heroin.
10.Psychotropic substance – means the substance, specified in the
Schedule to this Act, and such substances as the Federal Government
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may, by notification in the official Gazette, declare to be a
psychotropic substance.
11.Tracing – means the finding out the true nature, source, disposition,
movement or ownership of assets and includes determining the
movement or conversion of assets by any means, and “trace” shall be
construed accordingly.
3. CALCULATION OF PERCENTAGES IN LIQUID PREPARATION
 The Federal Government may make rules prescribing the methods by
which percentages in the case of liquid preparations shall be
calculated for this Act.
CHAPTER II (PROHIBITION AND PUNISHMENT)
4. PROHIBITION OF CULTIVATION OF NARCOTIC PLANTS
 No one shall cultivate any cannabis plant, coca bush or opium
poppy, or gather any portion of a cannabis plant, coca bush or
opiumpoppy.
5. PUNISHMENT FOR VIOLATION OF SECTION 4
 Whoever violates the provisions of section 4 of this Act shall be
punishable with imprisonment up to 7 years, or with fine, or with
both.
6. PROHIBITION OF POSSESSION OF NARCOTIC DRUGS, ETC.
 No one shall produce, manufacture, extract, prepare, possess, offer
for sale, sell, purchase, distribute, deliver on any terms whatsoever,
transport, dispatch, any narcotic drug, psychotropic substance or
controlled substance, except for medical, scientific or industrial
purposes in the manner and subject to such conditions as may be
specified under this Act.
7. PROHIBITION OF IMPORT OR EXPORT OF NARCOTIC DRUGS, ETC
(Past Papers)
1. No one shall import into Pakistan, export from Pakistan, transport
within Pakistan, transship any narcotic drug, psychotropic
substance save in accordance with rules of this Act and with the
conditions of any license, permit or authorization.
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2. The Federal Government may make rules permitting and regulating
the import into and export from Pakistan, transport within Pakistan
and shipment of narcotic drugs, Psychotropic substance or
controlled substances, and such rules may prescribe the ports or
places at which these substance may be imported, exported,
transported within Pakistan and the fees that may be charged
there.
8. PROHIBITION ON TRAFFICKING OR FINANCING THE
TRAFFICKING OF NARCOTIC DRUGS, ETC (Past Papers)
1. No one Shall:
a. Organize, manage, traffic in, or finance the import, transport,
manufacturing or trafficking of, narcotic drugs, psychotropic
substances or controlled substances.
b. Use violence or arms for committing or attempt to commit an
offence punishable under this Act.
9. PUNISHMENT FOR VIOLATION OF SECTION 6, 7 AND 8
1. Whoever violates the provisions of Sections 6, 7 or 8 shall be
punishable with:
a. Imprisonment up to 2 years, or with fine, or with both, if the
quantity of the narcotic drug, psychotropic substance or
controlled substance is 100 grams or less.
b. Imprisonment up to 7 years and shall also be liable to fine, if the
quantity of the narcotic drug, psychotropic substance or
controlled substance exceeds 100 grams but does not exceed on
kilogram.
c. Death or imprisonment for life, or imprisonment up to 14 years
and shall also be liable to fine which may be up to 1 million
rupees, if the quantity of narcotic drug, psychotropic substance
or controlled substance exceeds 1 kg.
10.PROHIBITION ON OWNING, OPERATING PREMISES OR
MACHINERY FOR MANUFACTURE OF NARCOTIC DRUGS, ETC.
 No one shall own, manage operate or control any premises, place,
equipment or machinery for the purpose of manufacture or
production of cannabis, cocaine, opium, opium derivatives, narcotic
drugs, psychotropic substance or controlled substance save in
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accordance with the conditions of a license and payment of such
fees as may be prescribed.
11.PUNISHMENT FOR VIOLATION OF SECTION 10
 Whoever violates the provision of Section 10 shall be punishable
with imprisonment up to 25 years but shall not be less than 10
years and shall also be liable to fine of 1 million rupees.
12.PROHIBITION OF ACQUISITION AND POSSESSION OF ASSETS
DERIVED FROM NARCOTIC OFFENCES (Past Papers)
1. No one shall Knowingly:
a. Possess, acquire, use, convert, assign or transfer any assets
which have been derived, obtained, directly or indirectly,
either in his own name or in the name of his associates,
relative or any other person through an act or omission
relating to narcotic substances which constitutes an offence
punishable under this Act, the Custom Act, 1969, the
prohibition Order, 1979 or the control of Narcotic Substances
Ordinance, 1996.
b. Hold or possess on behalf of any other person any assets
which violates this law.
c. Conceal or disguise the true nature, source, location,
disposition, movement, title, or ownership of such assets by
making false declaration in relation thereto.
13. PUNISHMENT FOR VIOLATION OF SECTION 12
 Whoever violates the provisions of Section 12 shall be punishable
with imprisonment up to 14 years but shall not be less than 5 years
and shall also be liable to fine which shall not be less than the
prevailing value of the assets and such assets shall also be liable to
forfeiture to the Federal Government.
14.PROHIBITION ON AIDING, ABETMENT OR ASSOCIATION IN
NARCOTIC OFFENCES (Past Papers)
 No one shall, within or outside Pakistan, participate in, associate or
conspire to commit, attempt to commit, aid, abet, facilitate, induce
or counsel the commission of an offence punishable under this Act.
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15.PUNISHMENT FOR VIOLATION OF SECTION 14
 Whoever participates in, associates, conspires to commit, attempts
to commit, aids, abets, facilitates, induces or counsels the
commission of an offence in violation of section 14 shall, whether
such offence be or be not committed in consequence and not
withstanding anything contained in section 116 of the Pakistan
Penal Code, 1860, be punishable for the offence or lesser
punishment as may be awarded by the Court.
16.PUNISHMENT FOR OFFENCE FOR WHICH NO PUNISHMENT IS
PROVIDED
 Whoever violates any provision of this Act or any rule or order
made, or any license, permit or authorization issued hereunder, for
which no punishment is separately provided in this Chapter, shall
be punishable with imprisonment up to 1 year, or with fine up to
5000 rupees, or with both.
17.OBSTRUCTIONS TO OFFICERS
 Whoever hinders or obstructs any officer in the performance of his
functions under this Act or willfully furnishes false information to
any officer shall be punishable with imprisonment up to 3 years, or
with fine, or with both.
18. LIMIT OF FINE, ETC.
 Where for any offence under this Act no amount of minimum fine
has been fixed, the Special Court shall impose the fine keeping in
view the quality and quantity of the narcotic drug, psychotropic
substance or controlled substance involved in offence.
19.FORFEITURE OF ASSETS OF AN OFFENDER
 Notwithstanding anything contained in section 13, where the
Special Court finds a person guilty of an offence punishable under
this Act and sentences him to imprisonment for a term exceeding 3
years, the Court shall also order that his assets derivable from
trafficking in narcotic substances shall stand forfeited to the
Federal Government.
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CHAPTER II (SEARCH AND INVESTIGATION)
20.UNDERCOVER AND CONTROLLED DELIVERY OPERATIONS
1. Any treaty, arrangement or understanding with any foreign State to
which Pakistan may from time to time be part, the Federal
Government may give written approval to controlled delivery
operations, for the purpose of gathering evidence in Pakistan or
elsewhere relating to the commission of any offence against this
Act or a similar law of a foreign State.
2. Approval may not be given unless the Federal Government:
a. Suspects that persons, whose identity may or may not be
known, have engaged in, are engaging in or are about to
engage in, conducting an offence against this Act or a similar
law of a foreign State.
b. Is satisfied that the proposed operations are properly
designed to give such persons an opportunity to manifest
that conduct or provide other evidence of it.
3. The federal Government may give approval from time to time for a
period not exceeding 3 months.
4. The activities which may be undertaken by an authorized
participant in the course of a controlled delivery and undercover
operation include:
a. Allowing any conveyance to enter or leave Pakistan.
b. Allowing any narcotic drug, psychotropic substance,
manufactured drug, controlled substance, property or other
thing in or on the conveyance to be delivered or collected.
c. Using such force as may be reasonable in the circumstances
to enter and search the conveyance.
d. Placing a tracking device in or on the conveyance.
e. Allowing any person who has possession or custody of the
narcotic drug, psychotropic substance, manufactured drug,
controlled substance, property or other thing to enter or
leave Pakistan.
5. Notwithstanding anything contained in any other law for the time
being in force an authorized participant in an undercover operation
or a controlled delivery shall not incur any criminal liability by
taking part in it in accordance with the terms of approval.
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6. Any drug of dependence, controlled chemical, controlled
equipment or controlled material imported into Pakistan in the
course of an approved undercover operation or controlled delivery
shall be liable to be dealt with as if it were a prohibited import for
the purposes of the Customs Act, 1969.
CHAPTER VII (NATIONAL FUND FOR CONTROL OF DRUG ABUSE)
21.NATIONAL FUND FOR CONTROL OF DRUG ABUSE
1. The Federal government may, by notification in the official Gazette,
constitute a Fund to be called the National Fund for Control of Drug
Abuse, consisting of:
a. Grants from the Federal Government or Provincial Governments.
b. The sale proceeds of any assets forfeited under this Act or any
other law for the time being in force.
c. The sale proceeds of unserviceable commodities and vehicles
provided by the donor for narcotics control purposes.
d. Any grants made by any person or institution.
e. Any income from the investment of the amounts credited to the
Fund.
2. All receipts shall be credited to a Head of Account in the Public
Account duly authorized by the Auditor-General of Pakistan.
3. The purpose and object of the Fund shall be to meet the expenditure
incurred in connection with the control and eradication of trafficking
in, and abuse of, narcotic drugs, psychotropic substances, controlled
substances, or treatment and rehabilitation of drug addicts and for
purposes specified by the federal Government.
4. The management, overall control and supervision of the affairs of the
Fund shall vest in a Governing Body consisting of a Chairman and
such other members as may be appointed by the Federal
Government by a notification in the official Gazette, on prescribed
terms and conditions.
5. The Governing Body shall have the powers to regulate its own
procedures and co-opt members as it may consider appropriate.
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Chapter 7 – The Poisons Act 1919
THE POISONS ACT 1919
 The Poisons Act, 1919
2. POWER OF THE PROVINCIAL GOVERNMENT TO REGULATE
POSSESSION FOR SALE AND SALE OF ANY POISON
1. The Provincial Government may regulate the possession for sale,
whether wholesale or retail, of any specified poison within the
territories under its administration.
2. Such rules may provide for:
a. The grant of licenses to possess any specified poison for sale,
wholesale or retail, and the fixing of the fee to be charged for such
licenses.
b. The classes of persons to whom alone such licenses may be
granted.
c. The classes of persons to whom alone any such poison may be
sold.
d. The maximum quantity of any such poison which may be sold to
any one person.
e. The maintenance by vendors of any such poison of registers of
sales, the particulars to be entered in such registers, and the
inspection of the same.
f. The safe custody of such poisons and the labelling of the vessels,
packages or coverings in which any such poison is sold or
possessed for sale.
3. POWER TO PROHIBIT IMPORTATION INTO PAKISTAN OF ANY
POISON EXCEPT UNDER LICENSE
 The Federal Government may, by notification in the official Gazette,
prohibit the importation of any specified poison into Pakistan except
under the conditions of a license and may by rule regulate the grant
of licenses.
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Chapter 7 – The Poisons Act 1919
4. POWER TO REGULATE POSSESSION OF ANY POISON IN CERTAIN
AREAS
1. The Provincial Government may regulate the possession of any
specified poison in any local area in which the use of such poison for
the purpose of committing murder or mischief by poisoning cattle
appears to it.
2. In making any rule, the Provincial Government may direct that any
violation shall be punishable with imprisonment for up to one year,
or with fine up to one thousand rupees, or with both.
5. PRESUMPTION AS TO SPECIFIED POISONS
 Any substance specified as a poison in a rule made under this Act
shall be considered a poison for the purposes of this Act.
6. PENALTY FOR UNLAWFUL IMPORTATION, ETC.
1. Whoever violates any rule or imports any poison (whose importation
is for the time being restricted) without a license into Pakistan or
breaks any condition of a license for the importation of any poison
granted to him shall be punishable:
a. On a first conviction, with imprisonment up to three months, or
with fine up to five hundred rupees, or with both.
b. On a second conviction, with imprisonment up to six months, or
with fine up to one thousand rupees, or with both.
7. POWER TO ISSUE SEARCH WARRANTS
1. The District Magistrate, and the Sub-divisional Magistrate may issue a
warrant for the search of any place in which he suspects that any
poison is possessed or sold violating this Act.
2. The person to whom the warrant is directed may enter and search
the place, and Code of Criminal Procedure, shall apply to the
execution of the warrant.
8. RULES
1. Provincial Government may make rules to carry out the purposes and
objectives of this Act.
2. All rules made by the Federal Government or by the Provincial
Government under this Act shall be published in the official Gazette.
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Chapter 8 – The Factories Act 1934
THE FACTORIES ACT 1934
1. This Act may be called the Factories Act, 1934.
3. It shall come into force on the 1st
day of January 1935.
1. Adolescent – means a person who has completed his 15th
but has not
completed his 17th
year.
2. Adult – means a person who has completed his 17th
year.
3. Child – means a person who has not completed his 15th
year.
4. Day – means a period of 24 hours beginning at mid-night.
5. Week – means a period of 7 days beginning at mid-night on Saturday
night.
6. Power – means electric energy, and any other form of energy which
is mechanically transmitted and is not generated by human or animal
agency.
7. Manufacturing process – means any process:
a. For making, altering, repairing, ornamenting, finishing or
packing, or otherwise treating any article or substance with a
view to its use, sale, transport, delivery or disposal.
b. For pumping oil, water or sewage.
c. For generating, transforming or transmitting power.
8. Worker – means a person employed directly or through an agency
whether for wages or not in any manufacturing process, or in
cleaning any part of the machinery or premises used for a
manufacturing process, or in any other kind of work whatsoever,
incidental to or connected with the subject of the manufacturing
process but does not include any person solely employed in a clerical
capacity in any room or place where no manufacturing process is
being carried on.
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9. Factory – means any premises, including the precincts thereof,
whereon ten or more workers are working, or were working on any
day of the preceding twelve months, and in any part of which a
manufacturing process is being carried on or is ordinarily carried on
with or without the aid of power, but does not include a mine,
subject to the operation of the Mines Act, 1923 (IV of 1923).
10.Machinery – includes all plant whereby power is generated,
transformed, transmitted or applied.
11.Occupier – means the person who has ultimate control over the
affairs of the factory.
3. REFERENCE TO TIME OF DAY
 References to time of day in this Act are references to Pakistan
Standard time.
4. SEASONAL FACTORIES (Past Papers)
1. For the purposes of this Act, a factory, which is exclusively engaged in
one or more of the following manufacturing processes, namely,
cotton ginning, cotton or cotton jute pressing, the decortication of
groundnuts, the manufacture of coffee indigo, lac, rubber, sugar
(including gur) or tea or any of the aforesaid processes, is a seasonal
factory.
2. The Provincial Government may, by notification in the Official
Gazette, declare any specified factory in which manufacturing
processes are ordinarily carried on for more than 180 working days in
the year and cannot be carried on except during particular season to
be a seasonal factory for the purposes of this Act.
5. POWER TO APPLY PROVISIONS APPLICABLE TO FACTORIES TO
CERTAIN OTHER PLACES
 The Provincial Government may, by notification in Official Gazette,
declare that all or any of the provisions of this Act applicable to
factories shall apply to any place where a manufacturing process
is being carried on whenever five or more workers are working
there on any one day of the twelve months immediately
preceding.
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6. POWER TO DECLARE DEPARTMENTS TO BE SEPARATE
FACTORIES
 The Provincial Government may, by order in writing, direct that the
different departments or branches of a specified factory shall be
treated as separate factories for all or any of the purposes of this Act.
7. POWER TO EXEMPT ON A CHANGE IN THE FACTORY
 When the Provincial Government is satisfied that, following upon a
change of occupier of a factory or in the manufacturing process
carried on there, the number of workers for the time being working
in the factory is less than 20 during the ongoing 12 months, it may
exempt such factory from operation of this Act.
8. POWER TO EXEMPT DURING PUBLIC EMERGENCY
 In any case of public emergency the Provincial Government may, by
notification in the Official Gazette, exempt any factory from the
provisions of this Act for such period as it may think fit.
9. NOTICE TO INSPECTOR BEFORE COMMENCEMENT OF WORK
1. Before work is begun in any factory after the commencement of this
Act, the occupier shall send a written notice to the Inspector
containing:
a. The name of the factory and its situation.
b. The address to which communications relating to the factory
should be sent.
c. The nature of the manufacturing processes to be carried on in
the factory.
d. The nature and amount of the power to be used.
e. The name of the person who shall be the manager of the
factory for the purposes of this Act.
f. Such other particulars as may be prescribed for the purposes of
this Act.
2. Whenever another person is appointed as manager the occupier shall
send written notice to Inspector of the change, within 7 days from
the date on which the new manager assumes charge.
3. During any period for which no person has been designated as
manager of a factory, the occupier himself, shall be considered to be
the manager of the factory for the purposes of this Act.
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CHAPTER II (THE INSPECTING STAFF) (Past Papers)
10.INSPECTORS
1. The Provincial Government may, by notification in the Official Gazette,
appoint appropriate persons as Inspectors for the purposes of this Act.
2. The Provincial Government may appoint any person to be a Chief
Inspector, who shall exercise the powers of an Inspector throughout
the Province in addition to the powers of Chief Inspector.
3. No person shall be appointed to be an Inspector or a Chief Inspector,
who is directly or indirectly interested in a factory or in any process or
business carried on there or in any patent or machinery connected
therewith.
4. Every District Magistrate shall be an Inspector for his district.
5. The Provincial Government may also appoint appropriate public
officers as additional Inspectors for the purposes of the Act.
6. Any area having more than one Inspectors, the Provincial Government
may declare the powers which Inspectors shall exercise, and the
Inspectors to whom the prescribed notices are to be sent.
7. Every Chief Inspector and Inspector shall be considered to be a public
servant.
11.POWERS OF INSPECTOR
1. An Inspector may, within the local limits for which he is appointed:
a. Enter with his assistants, any place suspected as a factory or
capable of being declared to be a factory under this act.
b. Make examination of the premises and plant and of any
prescribed registers and take evidence of persons as prescribed by
the Act.
c. Exercise such other powers as may be necessary for carrying out
the purposes of this Act.
12.CERTIFYING SURGEONS
1. The Provincial Government may appoint appropriate registered
medical practitioners as certifying surgeons for the purposes of this
Act.
2. A certifying surgeon may authorize any registered medical
practitioner to exercise any of his powers under this Act.
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CHAPTER III (HEALTH AND SAFETY) (Past Papers)
13.CLEANLINESS
 Every factory shall be kept clean and free from vapors arising from any
drain and in particular:
a. Accumulation of dirt shall be removed daily by sweeping from
the floors and benches of work-rooms and from staircases and
disposed of in a suitable manner.
b. The floor of every work-room shall be cleaned at least once in
every week by washing, using disinfectant.
c. Where the floor is liable to become wet in the course of any
manufacturing process to such extent as is capable of being
drained, effective means of drainage shall be provided and
maintained.
d. All inside walls and partitions, all ceilings, or tops of rooms and
walls, sides and tops or passages and staircases shall:
i. Where they are painted or varnished, be repainted or
revarnished at least once in every five years.
ii. Where they are painted or varnished and have smooth
impervious surfaces, be cleaned at least once in every 14
months.
iii. The whitewashing or color washing shall be carried out at
least once in every 14 months.
 The dates on which the processes of refurnishing are carried out shall
be entered in the prescribed register.
 If the nature of the operations carried on in a factory is not possible
for the occupier to comply with this Act, the Provincial Government
may, by an order, exempt such factory from any of the provisions and
specify alternative methods for keeping the factory in a clean state.
14.DISPOSAL OF WASTES AND EFFLUENTS
1. Effective arrangements shall be made in every factory for the disposal
of wastes and effluents due to the manufacturing process carried on
therein.
2. The Provincial Government may make rules prescribing the
arrangements to be made for disposal of waste.
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15.VENTILATION AND TEMPERATURE
1. Effective provisions shall be made in every factory for securing and
maintaining in every work-room:
a. Adequate ventilation by the circulation of fresh air.
b. Such temperature as will secure to workers there, reasonable
conditions of comfort and prevent injury to health, and in
particular:
i. The walls and roofs shall be of such material and so
designed that such temperature shall not be exceeded
but kept as low as practicable.
ii. Where the nature of the work carried on in the factory
involves the production of excessively high temperature,
adequate measures shall be taken to protect the workers,
separating the process which produces such temperature
from the work-room by insulating the hot parts.
2. The Provincial Government may prescribe a standard of adequate
ventilation and reasonable temperature for any factory and direct that
a thermometer shall be provided and maintained in such place and
position as may be specified.
3. if it appears to the Provincial Government that in any factory
excessively high temperature can be reduced by such methods as
whitewashing, spraying or insulating and screening outside walls or
roofs or windows, or by raising the level of the roof, or by insulating
the roof either by an air space and double roof or by the use of
insulating roof materials, or by other methods, it may prescribe such
of these or other methods to be adopted in the factory.
16.DUST AND FUME (Past Papers)
1. In every factory where, the manufacturing process gives off any dust
or fume or other impurity likely to be injurious to the workers,
effective measures shall be taken to prevent its accumulation in any
work-room and its inhalation by workers.
2. In any factory no stationary internal combustion engine shall be
operated unless the exhaust is conducted into open air and exhaust
pipes are insulated to prevent radiation heat likely to be injurious to
the workers employed in the work-room should be managed
adequately.
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17.ARTIFICIAL HUMIDIFICATION
1. The Provincial Government may, in respect of all factories in which
humidity of the air is artificially increased, make rules:
a. Prescribing standards of humidification.
b. Regulating the methods used for artificially increasing the
humidity of the air.
c. Directing prescribed tests for determining the humidity of the
air to be correctly carried out and recorded.
d. Prescribing methods to be adopted for securing adequate
ventilation and cooling of the air in the work-rooms.
2. In any factory in which the humidity of the air is artificially increased,
the water used for the purpose shall be effectively purified before use.
3. If it appears to an Inspector that the water used in a factory for
increasing humidity is not effectively purified, he may send written
order to factory manager, specifying the measures which should be
adopted, and requiring them to be carried out before a specified date.
18.OVERCROWDING
1. No work-room in any factory shall be over-crowded to an extent
injurious to the health of the workers employed.
2. There shall be provided for every worker employed in a work-room:
a. At least 350 cubic feet of space in the case of a factory in
existence on the date of the commencement of the Labor Laws
(Amendment) Ordinance, 1972.
b. At least 500 cubic feet of space in the case of a factory built
after the commencement of the Labor Laws (Amendment)
Ordinance, 1972.
19.LIGHTING
1. In every part of a factory where workers are working or passing, there
shall be provided and maintained:
a. Sufficient and suitable lighting, natural or artificial, or both.
b. Emergency lighting of special points in work-room and passages
to function automatically in case of a failure of the ordinary
electric system.
2. In every factory all glazed windows and sky-lights used for the lighting
of the work-room shall be kept clean on both the outer and inner
surfaces and free from obstruction as far as possible.
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3. In every factory effective provisions shall be made to prevent:
a. Glare either directly from any source of light or by reflection
from a smooth or polished surface.
b. The formation of shadows to such an extent as to cause eye
strain or risk of accident to any worker.
4. The Provincial Government may prescribe standards of sufficient and
suitable lighting for factories.
20. DRINKING WATER
1. In every factory effective arrangements shall be made to provide and
maintain at suitable points of sufficient supply of drinking water.
2. All such points shall be legibly marked "Drinking Water" in a language
understood by the majority of the workers and no such point shall be
situated within twenty feet of any washing place, urinal or latrine.
3. In every factory wherein more than 250 workers are employed, cool
drinking water shall be provided during the hot weather and
arrangements shall also be made for:
a. The daily renewal of water.
b. Sufficient number of cups or other drinking vessels.
4. The Provincial Government may make rules for factories to secure
compliance with this Act.
21. LATRINES AND URINALS
1. In every factory:
a. Sufficient latrines and urinals of prescribed types shall be
provided and accessible to workers at all times while they are
in the factory.
b. Enclosed latrines and urinals shall be provided separately for
male and female workers.
c. Such latrines and urinals shall be adequately lighted and
ventilated and no latrine and urinal shall communicate with
any workroom except through an intervening open space or
ventilated passage.
d. All such latrines and urinals shall be maintained in a clean and
sanitary condition at all times with suitable detergents or
disinfectants or with both.
e. The floors and internal walls of the latrines shall up to a height
of 3 feet, be polished to provide an impervious surface.
93

2. The Provincial Government may prescribe the number of latrines and
urinals to be provided in any factory in proportion to the number of
male and female workers employed there.
22.SPITTOONS
1. In every factory there shall be provided a sufficient number of
spittoons which shall be maintained in a clean and hygienic condition.
2. The Provincial Government may make rules prescribing the type and
the number of spittoons and their location in any factory.
3. No person shall spit within the premises of a factory except in the
spittoons provided for the purpose. A notice for penalty of violation
shall be prominently displayed at suitable places in the premises.
4. Whosoever spits in violation shall be punishable with a fine of 2
rupees.
23.PRECAUTIONS AGAINST CONTAGIOUS OR INFECTIONS DISEASE
1. Each worker in a factory shall be provided with a "Hygiene Card' in
which during the month of January and July every year entries shall be
recorded after examination by appointed factory doctor to the effect
that the worker is not suffering from any contagious or infectious
disease. The fee of such an examination shall be fixed by the
Provincial Government and will be paid by the occupier or manager of
the factory.
2. If a worker is found to be suffering from any contagious or infectious
disease on an examination, he shall not be appointed on work till he is
declared free of such a disease.
24.POWER TO MAKE RULES FOR PROVISION OF CANTEENS
1. The Provincial Government may make rules requiring that in any
specified factory wherein more than two hundred and fifty workers
are ordinarily employed, an adequate canteen shall be provided for
the use of the workers.
2. The rules may provide for:
a. The date by which such canteen shall be provided.
b. The standards in respect of construction, accommodation,
furniture and other equipment of the canteen.
c. The foodstuffs to be served and the charges.
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25.PRECAUTIONS IN CASE OF FIRE (Past Papers)
1. Every factory shall be provided with such means of escape in case of
fire as may be prescribed.
2. If it appears to the Inspector that any factory is not provided with the
means of escape, he may give written notice to the manager of the
factory specifying the measures which should be adopted before a
date specified in the order.
3. In every factory the doors for exit from any room shall not be locked
or fastened so that they can be easily and immediately opened from
inside while any person is within the room.
4. In every factory every window, door or other exit for means of escape
in case of fire, shall be distinctively marked in a language understood
by the majority of the workers and in red letters of adequate size.
5. In every factory there shall be provided effective and clearly audible
means of giving warning in case of fire to every person employed.
6. A free passage-way giving access to each means of escape in case of
fire shall be maintained for the use of all workers in every room of the
factory.
7. In every factory where more than 10 workers are employed in any
place above the ground floor, or explosive or highly inflammable
materials are used or stored, effective measures shall be taken to
ensure that all the workers are familiar with the means of escape in
case of fire and have been adequately trained.
8. The Provincial Government may make rules for any factory, the means
of escape to be provided in case of fire and the nature and amount of
firefighting apparatus to be provided and maintained.
CHAPTER IV (RESTRICTIONS ON WORKING HOURS OF ADULTS)
26.WEEKLY HOURS
 No adult worker shall be required to work in a factory for more than
48 hours in any week and in case of seasonal factory not more than 50
hours in any week.
27.WEEKLY HOLIDAY
1. No adult worker shall be required to work in a factory on a Sunday
unless:
95

a. He had or will have a holiday for a whole day, three days
immediately before or after that Sunday.
b. The manager of the factory has, before that Sunday:
i. Delivered a notice to the office of the Inspector of his
intention to require the worker to work on the Sunday
and of the day which is to be substituted.
ii. Displayed a notice to that effect in the factory.
28.DAILY HOURS
 No adult worker shall be required to work in a factory for more than
nine hours in any day.
29.INTERVALS FOR REST
1. The periods of work of adult workers in a factory during each day shall
be fixed either:
a. So that no worker shall work for more than 6 hours before an
interval for rest of at least 1 hour.
b. So that no worker shall work for more than 5 hours before an
interval for rest of at least half an hour.
30.SPREAD OVER
 The periods of work of an adult worker in a factory shall be so
arranged that along with intervals for rest, they shall not spread over
more than ten and a half hours.
31.NOTICE OF PERIODS FOR WORK FOR ADULTS AND
PREPARATION
1. There shall be displayed a Notice of Periods for Work for Adults clearly
showing the periods which adult workers may be required to work.
2. The periods shown in the notice shall be fixed before-hand such that
workers working for these periods would not be working elsewhere.
3. Where all the adult workers in a factory are required to work within
the same periods, the manager of the factory shall fix those periods
for such workers generally.
4. Where all the adult workers in a factory are not required to work
within the same periods, the manager of the factory shall classify
them into groups according to the nature of their work.
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5. For each group which is not required to work on a system of shifts, the
manager of the factory shall fix the periods within which the group
may be required to work.
6. The Provincial Government may make rules prescribing forms for the
notice of Periods for Work for Adults and the manner in which it shall
be maintained.
32.COPY OF NOTICE OF PERIODS FOR WORK TO BE SENT TO
INSPECTOR
1. A copy of the Notice shall be sent in duplicate to the Inspector within
14 days after the commencement of this Act.
2. Any proposed change in the system of work in a factory which will
bring a change in the Notice shall be notified to the Inspector in
duplicate before the change is made.
CHAPTER V (SPECIAL PROVISIONS FOR ADOLESCENTS AND CHILDREN)
33.PROHIBITION OF EMPLOYMENT OF YOUNG CHILDREN
 No child who has not completed his 14th
year shall be allowed to work
in any factory.
34.NON-ADULT WORKERS TO CARRY TOKENS GIVING REFERENCE
TO CERTIFICATES OF FITNESS
1. No child who has completed his 14th
year and no adolescent shall be
allowed to work in any factory unless:
a. A certificate of fitness granted to him is in the custody of the
manager of the factory.
b. He carries a token giving a reference to such certificate while he
is at work.
35.CERTIFICATES OF FITNESS (Past Papers)
1. A certifying surgeon shall, on the application of any child or
adolescent who wishes to work in a factory, or, of the parent or
guardian of such person, examine such person and ascertain his
fitness for such work.
2. The certifying surgeon after examination, may grant to such person, in
the prescribed form:
97

a. A certificate of fitness to work in a factory as a child if he is
satisfied that such person has completed his 14th
year, that he
has attained the prescribed physical standards, and that he is fit
for such work.
3. A certifying surgeon may revoke any previously issued certificate if, in
his opinion, the holder of it is no longer fit to work in a factory.
4. Where a certifying surgeon or a practitioner authorized refuses to
grant a certificate or revokes a certificate, he shall state his reasons in
writing for so doing.
36.EFFECT OF CERTIFICATE GRANTED TO ADOLESCENT
1. An adolescent who has been granted a certificate of fitness to work in
a factory as an adult and carries a token giving reference to the
certificate, shall be considered an adult.
2. An adolescent who has not been granted a certificate of fitness to
work in a factory as an adult shall be considered a child.
37.RESTRICTIONS ON THE WORKING HOURS OF A CHILD (P Papers)
1. No child shall be allowed to work in a factory for more than 5 hours in
any day.
2. The hours of work of a child shall be so arranged that they shall not
spread over more than seven-and-a-half hours in any day.
3. No child or adolescent shall be allowed to work in a factory except
between 6 a.m. and 7 p.m.
4. No child shall be allowed work in any factory on any day on which he
has already been working in another factory.
38.NOTICE OF PERIODS FOR WORK FOR CHILDREN
1. There shall be displayed a Notice of Periods for Work for Children,
clearly showing the periods within which children may be required to
work.
2. The periods shown in the Notice shall be fixed beforehand such that
workers working for these periods would not be working elsewhere.
3. The Provincial Government may make rules prescribing form for the
Notice of Periods for Work for Children and the manner in which it
shall be maintained.
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39.REGISTER OF CHILD WORKERS
1. The manager of every factory in which children are employed shall
maintain a Register of Child Workers showing:
a. The name and age of each child worker in the factory.
b. The nature of his work.
c. The group, if any, in which he is included.
d. Where his group works on shifts, the relay to which he is
allotted.
e. The number of his certificate of fitness.
2. The Provincial Government may make rules prescribing the form of
the Register of Child Workers, the manner in which it shall be
maintained and the period for which it shall be preserved.
40. HOURS OF WORK TO CORRESPOND WITH NOTICE AND
REGISTER
 No child shall be allowed to work in violation of the Notice of Periods
for Work for Children and the entries made before-hand against his
name in the Register of Child Workers.
41.POWER TO REQUIRE MEDICAL EXAMINATION
1. Where an Inspector is of opinion:
a. That any person working in a factory without a certificate of
fitness it a child or an adolescent.
b. That a child or adolescent working in a factory with a certificate
is no longer fit to work in the stated capacity.
2. He may give notice to the manager of the factory, requiring that such
person, or child or adolescent shall be examined by a certifying
surgeon or by a practitioner and shall not be allowed to work.
42. POWER TO MAKE RULES
1. The Provincial Government may make rules:
a. Prescribing certificate of fitness to be granted or duplicates in
the event of loss of original certificates and fixing the fees for
certificates and duplicates.
b. Prescribing the physical standards to be attained by children
and adolescents.
c. Regulating the procedure of certifying surgeons.
99

Chapter 9 – Shops and Establishment Ordinance 1969
SHOPS AND ESTABLISHMENT
ORDINANCE 1969
 Shops and Establishment Ordinance 1969.
2. DEFINITIONS
1. Adult – means a person who has completed his 17th
year of age.
2. Child – means a person who has not completed his 14th
year of age.
3. Closed – means not open for the service of any customer or to any
business connected with the establishment.
4. Establishment – means a shop, commercial establishment, industrial
establishment, private dispensary, maternity home, residential hotel,
restaurant, cafe, cinema, theatre, circus, or other place of public
amusement or entertainment.
3. REFERENCE TO TIME OF DAY
 References to time of day in this Ordinance are references to
Pakistan Standard time.
4. POWER TO GRANT EXEMPTIONS
 Government may, by notification in the official Gazette, exempt any
establishment or any class or any employer or employee from the
operation of the provisions of this Ordinance on such conditions as it
may think fit.
5. WEEKLY HOLIDAY IN ESTABLISHMENTS
 Every person employed in any establishment shall be allowed one
day as holiday in each week, in addition to other leaves and holidays
allowed to him.
 No deduction of any allowed holiday shall be made from the wages of
any employee of any establishment.
100

6. OPENING AND CLOSING HOURS OF ESTABLISHMENT
 No establishment shall on any day remain open after 8:00 p.m.
 Every employer shall display a board specifying the hours during
which the establishment will remain open at a prominent place.
 No employee shall be required or permitted to work continuously in
any establishment for more than six hours.
7. OVER TIME WAGES
 When any employee is required to work over-time in any
establishment, the wages shall be calculated at double the ordinary
rate of wages payable to him.
8. TIME AND CONDITIONS FOR PAYMENT OF WAGES
 Every employer of an establishment shall fix the period in respect of
which wages to employees shall be payable.
 No wage period, so fixed, shall exceed one month.
 The wages of every employee in any establishment shall be paid on a
working day before the expiry of the 7th
day of the last working day.
9. ANNUAL LEAVE
 Every employee should be allowed leave with full wages for a period
of 14 days after continuous employment in an establishment for a
period of 12 months.
10. CASUAL AND SICK LEAVE
 Every employee shall be allowed casual leave with full wages for 10
days in a calendar year.
 Every employee shall be allowed sick leave with full wages for a total
period of 8 days in every year.
11. FESTIVAL HOLIDAYS
 Every employee shall be allowed 10 days festival holidays with full
wages in a year. The days and dates for such festival holidays shall be
notified to the employees by the employer in the beginning of the
calendar year.
12. WAGES DURING LEAVE OR HOLIDAY PERIOD
 For each day of the leave or holidays allowed to an employee he shall
be paid at the rate equivalent to the daily average amount, which,
101

during the 3 months before the leave or holidays, was being earned
by the employee.
13.TERMINATION OF EMPLOYMENT
 For terminating a permanent employee, one month’s notice in
writing shall be given either by the employer or by the employee and
one month’s wages calculated on the basis of average of wages
earned during the past three months shall be paid.
 For terminating a temporary employee no notice shall be necessary
but the services of a temporary employee shall not be terminated as
a punishment unless he has been given an opportunity of explaining
the charges placed against him.
14.PROHIBITION OF EMPLOYMENT OF CHILDREN
 No child shall be required or allowed to work in any establishment.
15.MAINTENANCE OF RECORDS AND REGISTERS
 Every employer shall maintain such records and registers and furnish
such information as may be prescribed.
16.REGISTRATION OF ESTABLISHMENT
 Every establishment, other than a one man shop and factories
employing clerical staff within the factory premises, shall be
registered with the Deputy Chief Inspector for the area within which
such establishment is situated.
 An application for registration of an establishment shall be made by
the employer in Form ‘A’ and shall submit challan of specified
amount.
 On receipt of the application and the fees, the Deputy Chief Inspector
shall register the establishment in the Register of Establishments to
be maintained in Form ‘B’ and shall issue a registration certificate to
the employer in Form ‘C’.
 The registration certificate shall be prominently displayed by the
employer at the establishment and shall be renewed after every two
years on depositing fee.
102

17.APPOINTMENT OF CHIEF INSPECTOR, DEPUTY CHIEF
INSPECTORS AND INSPECTORS
 Government may, by notification in the official Gazette, appoint:
1. Chief Inspector of Shops for the whole of the Province.
2. Deputy Chief Inspectors of Shops for such areas as may be
notified.
3. Chief Inspector of Shops shall specify appropriate person to be
Inspectors for the purposes of this Ordinance.
18.POWERS OF INSPECTORS
 An Inspector may enter into any place at a reasonable time to check
if records, registers or other documents are maintained, and may
require explanation of any prescribed record, register or other
documents.
19. PENALTIES
 If any employer, with intent to deceive, makes illegal changes, in any
register, record or the rules of this Ordinance, he shall, on conviction,
be punished with fine of 50 rupees and which may extend to 250
rupees.
20.POWER TO MAKE RULES
 Government may, by notification in the official Gazette, make rules
for carrying out the purposes of this Ordinance.
 In making rules, Government may direct that any person committing
violation shall, on conviction, be punishable with fine which may
extend to 50 rupees, and where the violation is a continuing one,
with a further fine which may extend to 10 rupees for every day,
after the first, during which the violation continues.
103

Topic Viz Past Papers Forensic Pharmacy
GM Hamad Fraz Anwar
FORENSIC PHARMACY PAST PAPERS
01: GENERAL INTRODUCTION
Q: What are essential drugs? Describe the measures adopted in National drug
policy to promote the rationale use of drugs? (10), Annual 2019
Q: What are the objectives of national drug policy? How the concept of essential
drugs is promoted under national drug policy? (10), Annual 2020
Q: Give brief answers:
i. Landed cost as per pricing policy (03)
ii. Form 6 and 7 for Alternative medicine (02)
iii. Reports of Government Analyst (10)
iv. Qualification of Federal Inspector (04)
Q: Write note on Drug Discount and Price Adjustment rules 2006 (10), Annual
2018
Q: Write down the Powers of Inspector under Drugs Act 1976. (10), Annual 2017
Q: Give Qualification and duties of Provincial Inspector under Drugs Act 1976.
(10), 2nd
Annual 2018
Q: Give duties of Federal Inspector under Drugs Act 1976. (10), Annual 2019
Q: How Inspector will distribute the portions of a sample taken from a Pharmacy
under Drugs Act 1976? (10), Annual 2019
Q: What procedure an Inspector will adopt under Drugs Act 1976 upon receipt of
report of a sample; declared sub-standard by Drug Testing Laboratory? (10),
Annual 2019
Q: Explain the procedure of sampling by an Inspector? (10) Annual 2015, 2020
Q: What are the functions of Provincial Quality Control Board (PQCB) and District
Quality Control Board (DQCB)? (07), Annual 2019
104

GM Hamad Fraz Anwar
Q: Describe the procedure of PQCB in a case of spurious drugs or un-registered
drugs referred by provincial inspector of drugs. (10), 2nd
Annual 2018
02: ROLE OF FORENSIC PHARMACIST
Q: Give composition of Drug Registration board. Define Forensic Pharmacy, what
is the role of forensic pharmacist in criminal cases? (10), Annual 2019
Q: What is forensic pharmacy what is the role of forensic pharmacist in cases of
fraud and white collar crimes. (10), Annual 2020
03: PHARMACEUTICAL ETHICS
No Questions in Past Papers
04: STUDY OF DRUG LAWS
THE DRUGS ACT 1976
Q: Describe the following under Drug Act 1976. (20), Annual 2015
i. Cognizance of offences
ii. Pleas
iii. Offences and Penalties
Q: Describe the following as under Drug Act 1976. (20), Annual 2016
i. Composition of Drug Registration Board
ii. Offences and Penalties
Q: Describe the following under Drug Act 1976. (20), 2nd
Annual 2016
i. Conditions under which a drug is registered
ii. Reports of Government Analyst
Q: Question Give brief answers of the following under the Drugs Act 1976. (20),
2nd
Annual 2016
i. Spurious drug
ii. Types of drug manufacturing licenses
iii. Qualification of Federal Inspector
iv. IMS data
v. Quarantine
105

GM Hamad Fraz Anwar
Q: Describe the followings under Drugs Act 1976. (20), 2nd
Annual 2017
i. Offences and penalties
ii. Drug courts
Q: Describe Prohibitions as given under section 23 of Drugs Act 1976. (10) Annual
2018, 2020
Q: What type of drugs/remedies cannot be advertised under Drugs Act 1976 and
rules framed thereunder? (10) 2nd
Annual 2018
PUNJAB DRUG RULES 2007
Q: What are the conditions of drug sale license? (10), Annual 2015
Q: What are conditions of drug sale license related with. (10), Annual 2016
i. Schedule B and 9 drugs
ii. Schedule E drug
Q: Enlist various types of drug sale license. How you will apply for the new license
of your pharmacy. (10), 2nd
Annual 2016
Q: What are conditions of drug sale license related with. (10), 2nd
Annual 2016
i. Registered Medical Practitioner (RMP)
ii. Schedule E drugs
Q: Mr. X want to start a business of sale of drugs including compounding and
dispensing. Discuss the extra conditions according to Punjab Drugs Rules 2007
which he has to fulfill to get permission for such service. (10), Annual 2018
Q: Write down the list of minimum requirements to establish a Pharmacy under
Punjab Drugs Rules 2007. (10), Annual 2019
Q: What are the conditions of drug sale license? (10), Annual 2019
Q: Discuss the conditions according to Punjab drugs rules 2007 to be fulfilled to
get permission to start a business of sales of drugs including compounding and
dispensing. (2020)
ADVERTISEMENT RULES
Q: What type of drugs can be advertised under Drugs Act 1976? Describe the
conditions to be fulfilled for advertisement of drugs. (20), Annual 2017
106

GM Hamad Fraz Anwar
Q: Enlist various categories of drugs/remedies that can be advertised without
permission from Government. (10), Annual 2018
LABELLING AND PACKING RULES 1986
Q: Describe the following under Drug (labeling and packing) Rules 1986. (10)
Annual 2016
i. Exemption
ii. Labelling of drugs for export
Q: Describe the following under Drug (labeling and packing) Rules 1986. (10), 2nd
Annual 2016
i. Labelling of medical devices
ii. Labelling of drugs for Government supply
Q: Give labeling requirements for external preparations under drugs labelling and
packaging rules 1986. (10), Annual 2017, 2018
DRAP ACT 2012
Q: Define the following terms as per DRAP Act 2012. (20), Annual 2016
i. Pharmacy services
ii. Biologicals
iii. Alternative medicine
iv. Power and functions of Drug Regularity Authority of Pakistan (DRAP).
Q: Define the following terms as per DRAP Act 2012. (20), 2nd
Annual 2016
i. Drug
ii. Medical devices
iii. Therapeutic goods
Q: What is the composition of Drug Regularity Authority of Pakistan (DRAP) (10),
Annual 2016, 2017, 2019, 2020
Q: Define the following terms as per DRAP Act 2012. (20), Annual 2017
i. Health and OTC products
ii. Medical devices
iii. Qualification of chief executive officer (CEO)
107

GM Hamad Fraz Anwar
Q: Describe the functions of Drug Regularity Authority of Pakistan (DRAP) (10),
Annual 2018
05: THE PHARMACY ACT 1967
Q: Discuss following (04 each), Annual 2015, 2016, 2017, 2020
i. Procedure for registration
ii. Preparation and maintenance of registers
iii. Certificate of registration
iv. Election of vice president
v. Furnishing of information
Q: Composition and functions of central pharmacy council (10), Annual 2016,
2016, 2018, 2019
Q: Discuss prohibition of practice without registration (10), Annual 2017
Q: Discuss bye-laws made by central and provincial council (5), Annual 2016
06: CONTROL OF NARCOTIC SUBSTANCE ACT 1997
Q: Describe prohibitions and penalties related to owning premises, possession of
assets, aiding/abetment in narcotic offences given under Control of Narcotic
Substances Act 1997. (10), Annual 2016
Q: Describe prohibitions and penalties related to possession, import/export and
trafficking of narcotic drugs given under Control of Narcotic Substances Act 1997.
(10), 2nd
Annual 2016
Q: Describe Prohibitions and Penalties under Control of Narcotic Substances Act
1997. (10), 2nd
Annual 2017
Q: Describe prohibitions and penalties for “aiding abetment” and owning the
premises of narcotic drugs as given under control of narcotic substances act 1997.
(10), Annual 2020
07: THE POISONS ACT 1919
108

GM Hamad Fraz Anwar
08: THE FACTORIES ACT 1934
Q: Discuss the following under Factory Act, Annual 2015
i. Seasonal factory (05)
ii. Restriction on the working hours of a child (05)
Q: What types of health and safety measures should be provided to workers
under Factory Act? (10), Annual 2016
Q: Discuss the following under Factory Act, 2nd
Annual 2016
i. Inspecting staff and their powers (05)
ii. Safety of workers (05)
Q: Discuss the following under Factory Act 1934, Annual 2017
i. Certificate of fitness (05)
ii. Restriction on the working hours of a child worker (05)
Q: Describe the following under Factory Act 1934, 2nd
Annual 2017
i. Precautionary measures taken in case of fire (05)
ii. Facilities provided to workers (05)
Q: Discuss the inspecting staff and their powers under Factory Act 1934. (05),
Annual 2018
Q: What types of precautionary measures should be taken in case or fire under
Factory Act 1934? (10), 2nd
Annual 2018, Annual 2020
Q: Describe the following under Factory Act 1934, Annual 2019
i. Precautions against dangerous fumes (05)
ii. Restrictions on working hours of a child (05)
09: SHOPS AND ESTABLISHMENT ORDINANCE 1969
109

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