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.
38

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.
43

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.
48

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

Chapter 4.5 – The Drugs Labeling and Packing Rules 1986
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

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