BPH 3206 - Lecture 1 To 5 - Pharmacy Law & Ethics

COURSE TITLE: PHARMACY LAW AND ETHICS
COURSE CODE: BPH 3206
PREPARED BY:
MST. RESHMA KHATUN
LECTURER, DEPARTMENT OF PHARMACY
PRIMEASIA UNIVERSITY, BANANI, DHAKA
DATE: 2021/02/22 to 2021/03/08
COURSE OUTLINE
 Pharmacy: Scope, opportunities in government and the armed forces
 Drug administration and pharmacy council of Bangladesh, their scope and
functions.
 Regulations and laws governing the practices of pharmacy (The pharmacy
ordinance 1976).
 Control of drug advertisements, prices, patented and trade market
medicine, proprietary medicine, schedules of drugs and poisons, regulation
of cosmetics and poison control.
 Polices, sales, regulation and law concerning to the manufacture,
possession, distribution, sale of drugs and poisons ->> The drug policy 1982,
Essential drug list, The drug act 1940, The drug control ordinance 1982
PHARMACY LAW AND ETHICS (BPH 3206)
“The Art and Science of Manufacturing and Dispensing

of Drugs and Biologicals to Prevent or Cure or Diagnose
Diseases and thereby Preserving Health of Humanity”
 Laws are Structured rules utilized to govern all of society.
Ethics is drived from Greek word “Ethos” means custom or

character.
• It refers to the practices or beliefs of certain groups (i.e., nursing
ethics, physicians ethics and pharmacy ethics)
Pharmacy Law and Ethics

 The governmental framework, laws, regulations, and the ethical
responsibilities applicable to pharmacists so that they will be able
to manufacture, trade and use of medicines to protect the public
health and ensure patients’ wellbeing
 It also incorporates other broad areas of law on pharmacy, such

as contracts, criminal law and torts.
Scope and opportunities of Pharmacy in Bangladesh
Scope and opportunities of Pharmacy in Bangladesh
 Scope and opportunities of Pharmacy in Government Services
 Government University Professors
 As a Superintendent of Drug, Assistant Director and Deputy
Director in DGDA
 As a Scientist in Government Institutes like BCSIR
 In Government undertaking Pharmaceutical Industries.
 As a Drug Procurement Officer.
 As a Pharmacist in Government hospitals
 Government Analysts and Forensic Scientists
 Research on tropical diseases, Public health
 Government Approved Chemist
 Government Certified Pharmacologist &Toxicologist
 Consultants (Mental health, Addiction, family planning,
poisons, self-medication, immunization)
 Scope and opportunities of Pharmacy in Armed Forces
 Pharmacist in Defense services (Army, Navy, Air-force)
e.g., Under the supervision of the Bangladesh Army, pharmacists

are appointed to work in the Bangladeshi contingent deployed in
Kuwait Deputation (OKP-5).
The Directorate General of Drug Administration(DGDA)
 Drug Regulatory Authority, under the Ministry of Health &

Family Welfare, Government of the People's Republic of
Bangladesh
 It is an organization entrusted with the responsibility of

ensuring the quality, efficacy and safety of pharmaceutical
products though the implementation of relevant legislation.
 Major Functions of DGDA:
1. Evaluation of the proposals of new projects of all systems of
medicines.
2. Issue and renewal of drug manufacturing licenses.
3. Issue and renewal of retail and whole sale drug licenses.
4. Registration and renewal of drug products.
5. Fixation of price and certification of price for drug products.
6. Inspection of pharmaceutical establishments
7. Approval of block list for the import of raw- and packaging
materials.
8. Approval of indent for import of finished drugs.
9. Surveillance and pharmacovigillance activity
10. Prosecution of cases in the drug courts and other courts
11. Issue of export licenses, FSC (Free Sales Certificate), GMP
(Good Manufacturing Practices) Certificate & CPP ( Certificate for
Pharmaceutical Products.)
Pharmacy Council of Bangladesh (PCB)
 The Pharmacy Council of Bangladesh (PCB)
is an Autonomous Organization under the
Ministry of Health and Family Welfare,
Govt. of the People's Republic of
Bangladesh. It was established under the
Pharmacy Ordinance, Ordinance No. X111
of 1976.
 Scope of and Function of PCB:

• The main objective of the Pharmacy Council of Bangladesh is
to regulate the practice of Pharmacy throughout Bangladesh.
• In addition to this the pharmacy council performs the

following functions:
 Function of PCB:
a) Approve examinations in pharmacy for the purpose of qualifying persons
for registration as pharmacists.
b) Prescribe the subjects in which approve examinations shell be held.
c) Approve the course of study and practical training in pharmacy for the
purpose of admission to approval examinations.
d) Prescribe the condition and procedure for admission of candidates to and
approved examination.
e) To lay down the standard of teaching to be maintained by the institutions
conducting the approved courses of study.
f) Prescribe the equipment and facilities to be made available to the
students.
g) To recognize degree or diploma in pharmacy for the purpose of registration
as pharmacist.
h) Prepare and maintain registers of pharmacists and apprentices in
pharmacy.
i) To register pharmacists and grant certificates of registration.
THE PHARMACY ORDINANCE 1976
 An Ordinance to establish a Pharmacy Council to regulate the
practice of pharmacy.
Composition of the Council:
(a) Secretary, Ministry of Health, Population Control and Family Planning, ex-
officio, who shall, unless the Government appoints any other officer to be the
President, also be the President of the Council
(b) The officer, if any, appointed under clause (a) to be the President of the
Council
(c) Directors of Health Services, ex-officio
(d) Head of the Department of Drug Administration, ex-officio
(e) Head of the Department of Pharmacy in the University of Dhaka, ex-officio
(f) four persons to be so nominated by the Government that one of them is a
Professor of Medicine and one is a Professor of Pharmacology of medical
institutions in Bangladesh
(g) one qualified pharmacist to be nominated by the Bangladesh Aushad Shilpa
Samity
(h) one person to be nominated by the Bangladesh Medical Association
(i) one qualified pharmacist to be nominated by the Bangladesh Chemists and
Druggists Samity
(j) Three persons to be nominated by the Pharmaceutical Society of
Bangladesh registered under the Societies Registration Act, 1860 (XXI of 1860).
Disqualification for membership
 A person, other than a Professor of a medical institution, shall not be
eligible for nomination as a member of the Council unless he is a registered
pharmacist:
 Provided that, for the purpose of the constitution of the first Council, a
person who is qualified to be registered as a pharmacist under this
Ordinance, shall be eligible for such nomination.
Committees of the Council

 The Council may constitute such Committees as it deems fit for the
purpose of advising it in the performance of its functions.
 A Committee constituted under sub-section (1) may co-opt as its member

any person whose assistance or advice it may consider necessary for the
efficient performance of its functions.
Meetings of the Council:
(1) The Council shall meet at such time and place, and a meeting of the Council
shall be summoned and conducted in such manner, as may be laid down by
its regulations:
Provided that, until such regulations are made, the President of the Council
may, by notice addressed to each member, summon and conduct a meeting at
such time and place and in such manner as he may deem expedient.
(2) The President or, in his absence, the Vice-President shall preside at every
meeting of the Council and, in the absence of both the President and the Vice-
President, the members present shall elect one amongst them to preside at the
meeting.
Finance:
The funds of the Council shall consist of the fees received by it under this
Ordinance and of such moneys as may be placed at its disposal by the
Government.
Accounts and audit:

(1) The Council shall maintain proper accounts and prepare annual statement of
accounts in such form as may be prescribed by regulations.
(2) The accounts of the Council shall be audited by the Comptroller and Auditor-
General of Bangladesh or any officer authorised by him in such manner as the
Comptroller and Auditor-General may think fit.
Annual report:
As soon as may be, after the close of every financial year, the Council shall
submit to the Government, an annual report giving an account of its
proceedings together with a statement of moneys received and expenses
incurred by it during that year.
Functions of the Council: The functions of the Council shall be-
(a) To approve examinations in Pharmacy for the purpose of qualifying
persons for registration as pharmacists
(b) To prescribe the subjects in which approved examinations shall be held
(c) To approve the courses of study and practical training in pharmacy for
the purpose of admission to approved examinations
(d) To prescribe the conditions and procedure for admission of candidates

to an approved examination
(e) To lay down the standard of teaching to be maintained by institutions

conducting the approved courses of study
(f) To prescribe the equipment and facilities to be made available to the

students
Functions of the Council:
(g) To recognise degree or diploma in Pharmacy for the purpose of
registration as pharmacists
(h) To cause inspection of institutions which conduct any course of study in

Pharmacy and of the teachings imparted and examinations held by them;
(i) To prepare and maintain Registers of pharmacists and apprentices in

pharmacy
(j) To register pharmacists and grant certificates of registration
(k) To hold examinations for the purpose of registration as pharmacists and
(l) To do such other acts and things as it may be empowered or required to

do by or under this Ordinance.
Power to make regulations:
(1) The Council may, with the previous approval of the Government, make
regulations for carrying out the purposes of this Ordinance.
(2) In particular and without 9[prejudice] to the generality of the foregoing

power, such regulations may provide for all or any of the following matters,
namely:ÔÇö
(a) The procedure for the meeting of the Council and its committees
(b) The management of the property of the Council
(c) Maintenance and audit of the accounts of the Council
(d) The procedure for election of the Vice-President
(e) The powers and duties of the President, Vice-President and members of
the Council
Power to make regulations:
(f) The terms and conditions of service of the Secretary and other officers
and staff of the Council
(g) Fees to be prescribed under this Ordinance
(h) Such other matters as are required by this Ordinance to be provided for
by regulations or are considered necessary for the efficient performance of
the functions of the Council.
(3) Until such time as the regulations are made, the President of the
Council may issue such instructions as he may consider necessary to
regulate all or any of the matters specified in sub-section (2); and any such
instructions shall stand rescinded upon the making of the regulations by
the Council.
CREDIT: 02
PREPARED BY:
MST. RESHMA KHATUN
DATE: 2021/02/24
 Control of Drug Advertisements
"Advertisement" includes:
 Any notice, circular or other document displayed on or in any public
place or public transport or published in any newspaper or periodical
and
 Any announcement made orally or by any means of producing or
transmitting light or sound and any trade circular, insert and level.
According to,
“THE DRUGS (CONTROL) ORDINANCE, 1982 (Ordinance No. VIII of 1982)
An ordinance to control manufacture, import, distribution and sale of
drugs.”
14. Control of advertisement and claims in respect of drugs.— No
person shall publish or take any part in die publication of any
advertisement which relates to the use of any drug or contains any claim
in respect of therapies or treatment without the prior approval of the
licencing authority.
 Control of Drug Advertisements
According to, National Drug Policy 2016
4.9 Control of drug advertising and promotion
a. ‘Code of Pharmaceutical Marketing Practices’ approved by Directorate
General of Drug Administration (DGDA) will be followed in drug (Including OTC
listed drugs) marketing to prevent circulation of false, unwanted, and misleading
information. Drug manufacturing companies and drug marketing organizations
will operate their marketing functions in accordance with the ‘Code of
Pharmaceutical Marketing Practices’. The aforementioned ‘Code of
Pharmaceutical Marketing Practices’ will be regularly updated.
b. Drug advertisement of any type is prohibited without prior approval of

licensing authority, and legal actions will be undertaken against unapproved
advertising. With the same objective, any unethical marketing and multi-level
marketing will be rigorously restrained.
c. With the prior approval of Drug Regulatory Authority, substantive, educational

and public awareness type of advertisement on oral rehydration salt, family
planning drugs and devices, water purifying drugs, antiseptic drugs and vaccines
used in expanded program on immunization will be permitted.
Control of Drug Prices
 “Drug Control Committee (DCC)” of DGDA (Directorate General of Drug
Administration) - controls and fixes the prices of drugs.
According to,
“THE DRUGS (CONTROL) ORDINANCE, 1982 (Ordinance No. VIII of 1982)
An ordinance to control manufacture, import, distribution and sale of
drugs.”
11. Fixation of price of drugs.—

(1) The Government may, by notification in the official Gazette, fix the
maximum price at which any medicine may be sold.
(2) The Government may by notification in the official Gazette, fix the
maximum price at which any pharmaceutical raw material may be
imported or sold.
 Control of Drug Prices
According to, National Drug Policy 2016
4.10 Transparent and rational pricing of drugs
a. The government will regularly update the guidelines for control of

drug prices, taking public health interest into account.
b. At least once a year drug prices will be updated based on the

government formulated guidelines .For public information, the retail
prices of all drugs will be published in the official website of
Directorate General of Drug Administration.
c. Prices of Ayurvedic, Unani, Herbal, Homeopathic and Biochemic

system of drugs that are locally produced and imported will be fixed-
up by the government.
d. Legal actions will be taken against person or establishments

associated with selling of drugs above the fixed price.
 Schedules of Drugs and Poisons
Scheduling: A national classification system that controls how

medicines and poisons are made available to the public.
 Medicines and poisons are classified into Schedules according

to the level of regulatory control over the availability of the
medicine or poison required to protect public health and
safety.
According to,
“Drugs, Poisons and Controlled Substances Act 1981”
 An Act to re-enact with Amendments the Law relating to Drugs,
Poisons and Controlled Substances, to amend the Health Act 1958
and the Crimes Act 1958 and for other purposes.
According to, “Drugs, Poisons and Controlled Substances Act 1981”
Poison or controlled substance means—

(a) A Schedule 1 poison; or
(b) a Schedule 2 poison; or
(c) a Schedule 3 poison; or
(d) a Schedule 4 poison; or
(e) a Schedule 5 poison; or
(f) a Schedule 6 poison; or
(g) a Schedule 7 poison; or
(h) a Schedule 8 poison; or (monitored poison)
(i) a Schedule 9 poison; or
(j) a regulated poison other than a Schedule 7 poison; or
(k) medicinal cannabis
 12. Poisons Code
(1) The Minister may prepare a Poisons Code.
(2) The Poisons Code must contain—

(a) a Poisons List; and
(b) any provisions (including appendices) of the Poisons
Standard concerning the labelling, storing, packaging or
advertising of poisons or controlled substances that the
Minister considers are in a form suitable for inclusion in the
Code; and
(c) any provisions (including appendices) of the Poisons
Standard relating to the interpretation of provisions
included in the Code under paragraph (a) or (b).
CREDIT: 02
PREPARED BY:
MST. RESHMA KHATUN
DATE: 2021/03/01
Proprietary Medicines:
• Also known as Patent Medicine
• A proprietary medicine is a preparation that is owned or controlled by
an individual or individuals. This control is held either by a copyright or
trade name/brand name, or by a patent.
In addition to that,
 When a pharmaceutical company first develops a new drug to be used
for a disease condition, it is initially sold under a brand name by which
the clinicians can prescribe the drug for the patient use.
 The drug is covered under patent protection, which means that only
the pharmaceutical company that holds the patent is allowed to
manufacture, market the drug and eventually make profit from it.
Shelf Life of Patent Drug (Proprietary Medicines):
• Every drug that has been developed by the original company has
patent protection, which lasts for a variable amount of time,
depending on the country and molecule.
• In the United States, for example, drug patents only last for about
twenty years.
• Furthermore, these patents apply for clinical trials long before to

assess a drug’s safety and efficacy.
• The effective patent period after the drug has finally received
approval is often around seven to twelve years.
• The majority of drugs, particularly the life saving ones, are then
manufactured and sold as generic drugs.
Generic Drugs:
 A generic drug is a pharmaceutical drug that contains the same
chemical substance as a drug that was originally protected by patents.
 According to guidelines from the United States Food and Drug
Administration (FDA), the generic drug must have the same active
ingredient as the brand name drug as well as the same dosage,
strength, safety, conditions of use and route of administration.
 Generic drugs are allowed for sale after the patents on the original
drugs expire. Since the active chemical substance is the same, the
medical profile of generics is believed to be equivalent in
performance.
• Although, generic drug has the same active pharmaceutical
ingredient (API) as the original, but it may differ in some
characteristics such as the manufacturing
process, formulation, excipients, color, taste, and packaging.
Example Generic Drugs:
• One example of a well known generic drug is metformin, which is
used to lower blood sugar levels in diabetes. Metformin is the generic
form of a drug which is also available under the brand name
“Glucophage”(Merck KGaA).
TRIPS (Trade-Related Aspects of Intellectual Property Rights)

 The World Trade Organization (WTO) is the only global international
organization that deals with the rules of trade between nations.
 Among all the regulations of The WTO’s Agreement, TRIPS (Trade-Related
Aspects of Intellectual Property Rights) is very significant for pharmaceuticals
industry.
 According to TRIPS agreement Patent protection will be granted for Innovator
Company that will last at least 20 years from the date of the patent
application filed.
WTO-TRIPS:
Doha convention: The November 2001 declaration of the Fourth Ministerial
Conference in Doha, Qatar, provides the mandate for negotiations on a range of
subjects.
1. Least-Developed Country Members: Least-developed country (LDC)
members will not be obliged, with respect to pharmaceutical products, to
implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to
enforce rights provided for under these Sections until 1 January 2016.
2. Bangladesh was categorized as LDC along with other 47 countries. As a
result, Bangladesh got exemption from enforcing patentable subject matter of
TRIPS Agreement until 1 January 2016.
Why LDC countries got the exemption?
1. LDC’s are least developed and very poor countries. Current economic
conditions of these countries do not allow them to import high priced, patented
medicine under patent protection.
• Moreover none of these countries have facilities to manufacture
the active pharmaceuticals ingredients.
2. TRIPS agreement also recognized the gravity of public health problems
affecting many developing and least-developed countries, especially those
resulting from HIV/AIDs, tuberculosis, malaria and other epidemics.
• So, there is a need for increased access of low cost medicine for the people
of these countries.
However,
 Vey recently, The Committee for Development Policy of the United Nations
(UN CDP) is set to recommend taking Bangladesh out from the list of the
least-developed countries (LDCs) to developed country (LDC graduation).
 Although the exit now is to take place in 2026, i.e., five years hence. In
response to a recent intervention by the government of Bangladesh, the UN-
CDP has agreed to extend the transition period by two more years.
 What about the impact LDC graduation of Bangladesh on the
pharmaceutical industry?
 The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPS) provides a special exemption (transition) period for the LDCs with
regard to providing patent protection for pharmaceutical products.
 This exemption period is to end in 2033. In other words, Bangladesh's
pharmaceutical industry will stop enjoying the flexibility seven years before
the expiry of the globally stipulated preferential period.
Ref.: https://www.un.org
https://www.thedailystar.net
CREDIT: 02
PREPARED BY:
MST. RESHMA KHATUN
DATE: 2021/03/03
 Drug Policy
 A drug policy is the policy, usually of a government, regarding the
control and regulation of drug substances, particularly those that are
addictive or cause physical and mental dependence.
 Governments try to combat drug addiction or dependence with policies
that address both the demand and supply of drugs, as well as policies
that mitigate the harms of drug use, and for medical treatment
 National Drug Policy (NDP)

 The World Health Organization (WHO) defines NDP as “a
comprehensive framework in which each component plays an
important role in achieving one or more of the general objectives of
the policy (access, quality, and rational use”.
 The policy must have the self-assurance of the several penalty area and
purposes, generating a comprehensive and reliable existence. The
system should address access to essential medicines (EMs).
 According to WHO, the General Objectives of a National Drug
Policy are to Ensure :
• Access: equitable availability and affordability of EMs.
• Quality: the quality, safety, and efficacy of all medicines.
• Rational use: the promotion of a therapeutically sound and cost-
effective method of drugs by health professionals and consumers.
National Drug Policy of Bangladesh

After independence (1971), it became a great challenge for the
Government of Bangladesh to ensure the availability and accessibility
of EMs. Despite this crisis due to lack of drug policy, the market was full
of unnecessary drugs.
• The country has gone through several stages of policy development
programs for drug policy, which ultimately delivered a deep-seated,
comprehensive, public-friendly NDP in 1982, as the effort made in
1973 did not work efficiently.
National Drug Policy, 1982
 The Expert Committee proposed a National Drug Policy with the
following objectives:
(1) To provide administrative and legislative support for ensuring quality
and availability of essential drugs which are of relevance to the health
needs of the majority of the population.
(2) To reduce the prices of drugs and medicines and to ensure
procurement of raw materials at the most competitive prices.
(3) To eliminate useless, non-essential and harmful drugs from the
market.
(4) To promote local production of finished drugs as well as of basic
pharmaceutical raw and packaging materials in the country.
(5) To ensure coordination among various administrative branches of the
Government in respect of drugs control and drug supply system.
(6) To develop a drug monitoring and information system, to prevent
wasteful misuse of drugs, to ensure their proper utilization.
Objective: Con...
(7) To promote the scientific development and application of unani,
ayurvedic and homeopathic medicines and to ensure their
standardization and quality by bringing these under the purview of drug
legislation.
(8) To improve the standard of hospital pharmacies and private retail
pharmacies by improving the facilities for education and training of
professional pharmacists.
(9) To ensure good manufacturing practices, each manufacturing
company must employ qualified pharmacists.
Significant Recommendations of NDP-1982: To achieve the
objective of national drug policy and to provide guidelines for the
formulation of the program the following actions are to be taken:
A. Selection and provision of essential drugs
a) Establish an essential list of 150 EMs and a supplementary list of
100 specific drugs. The basic list was subdivided into three levels of
use: 12 drugs for village workers; 45 medications for primary health
care; and all 150 drugs for tertiary care
b) Use generic names for the manufacture
c) Prepare and publish a National Formulary by 1983
d) Eliminate product patents and limit the use of process patents
B. Revise the 1940 Drugs Act to include
a) A registration system for Ayurvedic, Unani and homeopathic
medicines
b) Implementation of good manufacturing practices (GMP), together
with ample quality control
c) Regulating labeling and promotional activities
d) Price control
e) Prescription control of toxic/poisonous and abusing medicine
f) Establishing of specialized medicine courts and substantial
punishments
g) Regulation of technology transfer and licensing agreements with
foreign collaborators
h) Restriction of ownership of retail pharmacies to professional
pharmacists only
C. Drug Administration
i. Strengthen the Drug Administration administrative capacity by
educational interventions among drug inspectors up to the lowest
public administrative level of the country
ii. Set up a National Drug Control Laboratory by 1985
iii. Local production: The existing capacities of local pharmaceutical
companies shall be enhanced. Commission report advised to ban
multinational pharmaceutical industry from manufacturing simple
medicine like common analgesics vitamins, antacids.
iv. Control of Price: Government shall control the prices of finished
products as well as those of pharmaceutical raw and packaging materials
and intermediates. Level prices will be fixed for the 45 essential drugs for
primary health care and their corresponding raw materials. It will be
ensured that all raw and packaging materials of acceptable quality are
procured from international sources at competitive prices only.
v. Distribution and utilization: All public hospitals should institute
registered retail pharmacies under the supervision of qualified
pharmacists. A National Pharmacopoeia of Traditional Medicine should be
prepared.
GUIDELINES FOR EVALUATION OF AVAILABLE DRUGS
The Expert Committee agreed on 16 criteria as guidelin'es for evaluating
the drugs on the market in the country.
(1) In general combination drugs will be accepted only where no alternative
single drug is available for the purpose or where the single drug is not cost-
effective.
Exceptions will be made for oral rehydration salts (ORS), certain antimalarials,
co trimoxazole, iron with folic acid for use in pregnancy, combined oral
contraceptives (containing up to 35 ug oestrogen) and formulations specified
by the licensing authority for a multivitamin (B complex) tablet and paediatric
drops; hydrocortisone with antibiotic skin and eye preparations; and a
haemorrhoid preparation.
(2) The combination of an antibiotic with another antibiotic or antibiotic with
corticosteroids or other similar active substances will be prohibited.
Antibiotics harmful to children (e.g. tetracyclines) will not be allowed to be
manufactured in liquid form.
(3) The combination of analgesics in any form is unacceptable as there is no, or

only trivial, therapeutic advantage and such combination increases toxicity,
especially in the case of kidney damage and over dosage. The combination of
analgesics with iron, vitamins or alcohol is irrational and unacceptable.
(4) Due to the risk of addiction or dependency, any combination form of
codeine will not be allowed.
(5) Vitamins must be formulated as a particular/individual component products,
except for B complex. B12 should always be produced as a single-ingredient
injectable product. The combining of Vitamins with any other ingredient such as
minerals, glycerophosphate, etc., will also be prohibited. The liquid form of
vitamins was prohibited in order to prevent the wastage of resources used to
produce liquid vitamins, because it has no beneficial impacts on health.
(6) No multiple-ingredient cough mixtures, throat lozenges, gripewater, antacids
etc. will be accepted (either locally manufactured or imported). as these offer
no therapeutic advantages to outweigh their cost.
(7) The sale of tonics, enzyme mixtureslpreparations and so-called restorative
products flourishes on consumers’ ignorance. Most are habit-forming and, with
the exception of pancreatin and lactase, they are of no therapeutic value.
Henceforth local manufacture or importation of such products will be
discontinued. However, pancreatin and Iactase will be allowed to be
manufactured and/or imported as single ingredient products.
(8) Some medicines are being manufactured with only trivial difference in
composition from other products but having similar action (Me-too drugs). Such
duplication confuses both patients and doctors and will not be acceptable in
future.
(9) Products whose therapeutic value is doubtful, trivial or absent and products
that are judged harmful or subject to misuse will be banned.
(10) Prescription medicines and galenical preparations not included in the latest
edition of the British Pharmacopeia or the British Pharmaceutical Codex will be
prohibited unless there is strong evidence of need and of efficacy.
(11) Certain drugs, in spite of known serious side effects and the possibility of
misuse, having a favourable risk-benefit ratio will be permitted for restricted use
by specialists.
(12) Where a drug or a close substitute is being produced in the country
importation will not be allowed, as a measure of protection for the local
industry. This condition may be relaxed in some individual cases where local
production isinsufficient.
(13) A basic pharmaceutical raw material which is locally manufactured will also
be given protection as in (12) above.
(14) The role of multinational enterprises in providing medicines for this country
is acknowledged with appreciation. In view of the caliber of machinery and
technical know-how which lies in their hands for producing important and
innovative drugs for the country, the task of producing antacids and vitamins will
lie solely with the national companies, leaving the multinationals free to
concentrate their efforts and resources on those items not so easily produced by
smaller national companies. Multinationals will, however, be allowed to produce
injectable vitamins in single-ingredient products.
(15) No foreign proprietary medicines will be allowed to be manufactured
under licence in any factory in Bangladesh if the same or similar products are
available/manufactured in Bangladesh, as this leads to unnecessary high
prices and payment of royalties. In the light of this policy, all existing licensing
agreements should be reviewed.
(16) No multinational enterprise without its own factory in Bangladesh will be
allowed to market its products after manufacturing them in another factory in
Bangladesh on toll basis.
 The first eleven criteria were established completely on scientific
perceptive, although, the Principle 14 was based on political and
economic thoughts.
 The remaining four principles (12, 13, 15, and 16) were considered for
the assistance and growth of the homegrown, domestic
pharmaceutical manufacturing plant.
 There were 166 approved medicinal and therapeutic products available in
Bangladesh during the development and promotion of NDP-1982.
 Interestingly, 122 multinational pharmaceutical industries were
exporting medicines to the country from 23 countries.
 Additionally, 4,340 medicinal products were approved. These products
were either produced locally or imported.
 The commission banned 1,742 medicinal products by utilizing 16
principles of NDP-1982, as these medicines were either ineffective or
non-essentials.
 These banned 1,742 medicines were placed in one of three
categories:
Schedule I: Production of these drugs was to be stopped immediately
and stocks were to be collected from pharmacies and destroyed within
three months of the acceptance of the report.
Schedule II: These drugs were to be reformulated within six months on
the basis of the guidelines suggested by the committee.
Schedule III: A maximum of nine months was allowed for using up stocks
of these drugs.
Importation of raw materials for Schedule I and II drugs was prohibited .
Impacts of National Drug Policy 1982

1. Local production of allopathic, traditional and complementary
alternative drugs increased substantially.
2. Availability of EMs also increased remarkably with the increase in the

volume of local production of all types of recognized drugs, the
monetary value of which grew from Taka 1730 million in 1981 to about
Taka 41000 million in 2002.
3. Local companies increased their production share from 30% in 1970

to more than 80% in 2002.
4. Drug prices stabilized, increasing (practically a drop-in cost in real

times) by only 20%, compared to an increase of 179% in the consumer
price index. This made drugs more affordable to consumers.
5. The quality of the products was improved, and the proportion of
substandard drugs fell from 36% in 1970 to just 2% in 2002.
6. The volume of imported drugs and medicine in the country reduced

drastically.
7. Commendable progress occurred in the research, education, and

manufacturing of Unani, Ayurvedic, and Homeopathic- Biochemic
systems of medicine.
8. The less dependency on imports and prioritization of useful drugs

saved the country approximately US$ 600 million every year.
9. Bangladesh, a drug importing country, has become a drug exporting

country .
Essential Drugs:
• Essential medicine was defined in 1977 (WHO) as “medicines that are
of utmost importance, and are basic, indispensable and necessary for
the health needs of the population”.
• In 2002, EMs were again redefined by WHO as “EM are those that
satisfy the priority health care needs of the population. They are
selected with due regard to public health relevance, evidence of
efficacy, safety, and comparative cost-effectiveness.
According to, National Drug Policy-2016:
 List of Essential Drugs (Allopathic) = 285
 List of Essential Unani Medicines=223
 List of Essential Ayurvedic Drugs=100
 Homoeopathic Medicine=197
 List of Over-the-Counter (OTC) Drugs (Allopathic)=39
 List of Over-the-Counter (OTC) Ayurvedic Drugs=23
 List of Over-the-Counter (OTC) Drugs (Unani)=98
Ref.: National Drug Policy-2016 including Essential Drug List and OTC List.(PDF)
CREDIT: 02
PREPARED BY:
MST. RESHMA KHATUN LECTURER,
DEPARTMENT OF PHARMACY PRIMEASIA
UNIVERSITY, BANANI, DHAKA
DATE: 2021/03/08
The Drugs Act, 1940
The Drugs Act, 1940 an Act that regulates the import, export, manufacture,
distribution, and sale of drugs in the country.
 It was originally enacted by the Government of India on 10th April 1940 and
was subsequently modified to suit the changed circumstances, and adopted
by the Pakistan Government on 21st January 1957.
 It was adapted in Bangladesh in 1974 vide Bangladesh Laws (Revision

and Declarations) (Amendment) Act-1974 as Act No. LIII of 1974.
 This Act, on the one hand, seeks to regulate the import of drugs into the
country so that no sub-standard and harmful drugs find their way in, and
on the other, it exercises control over the manufacture of drugs so that
no substandard or spurious drugs are produced in the country.
The Drugs Act, 1940
 As the handling, compounding, dispensing and distribution of drugs require
specialist's attention, the Act also provides for the regulation of sale and
distribution of drugs whereby only qualified and trained persons can
undertake the handling, compounding, dispensing and distribution of drugs.
 By this Act the import of certain classes of drugs is permitted only under the
licenses or permits issued by relevant authorities appointed by the
Government.
 All classes of drugs imported in the country are, however, required to comply
with the prescribed standards and are to be labelled and packed in the
manner prescribed in the Schedule.
 Licenses are also required for the manufacture of all classes of drugs and for
the sale or distribution of drugs in the country.
 Regular control over the manufacture and sale is exercised by periodic
inspection of licensed premises by drug inspectors who are specially
appointed for the purpose under the Act. Surveillance over the standards of
drugs is maintained by taking samples from drugs, manufactured or offered
for sale, and by getting them tested in the Central Drugs Laboratory.
The Drugs Act, 1940
 Certain Drug Rules are framed under the provisions of the Act, which
prescribe the manner of labelling and packing the various classes of drugs.
 There are 20 schedules to the rules, which deal with the list of forms, drugs,
medicines, poisons, rates of fees to be paid for analysis of drugs, life period
of drugs, etc.
Under this Act the government has constituted :
• A 'Drugs Technical Advisory Board‘: advises the government on

technical matters arising out of the enforcement and administration of
the Act.
• The 'Drugs Consultative Committee' advises the Government and the

Board to ensure the administration of the Act throughout the country.
(Ref. The Drug Act, 1940 ;

& By Dr. Zia Uddin Ahmed; banglapedia)
Poisons Act, 1952
An Act which controls the import, possession and sale of poisons in
the country.
 Origin of the Act:
It was originally enacted by the Government of India in 1919 as Poisons
Act, 1919 to regulate the import, possession and sale of poisons in India.
 Amendment:
 The Act was later on amended to suit the changed circumstances and
adopted by the Pakistan Government in 1952 as Poisons Act, 1952.
 After liberation, the Government of the People's Republic of
Bangladesh amended the Act accordingly and adopted it to regulate
the import, possession, use and sale of poisons in Bangladesh.
For the purpose of the Act, all substances, that cause death or fatally
affect the animal systems, if ingested even in smaller doses, and those
substances which are specified as poisons in notifications issued under
the Act, are designated as 'Poisons'.
Poisons Act, 1952
 Classification of poison:
Poisons under the Act are classified into two groups:
• Group I: In this group are included those poisons that are used in
the treatment of human diseases. These poisons can be
prescribed only by the registered physicians and sold only by the
licensed sellers.
• Group II: This group includes those poisonous substances which
are used both in the treatment of human diseases, and as
antiseptics and pesticides (such as insecticides, rodenticides,
fungicides, herbicides, etc). These are sold by both licensed and
unlicensed sellers.
 The Rules under the Poisons Act have been divided into 17 Schedules
for the purpose of regulating the various affairs of the poisons. The
provisions of the Act are in addition to the rules which have been
made for the dispensing and sale of poisons under the Drugs Act,
1940.
Poisons Act, 1952
 The import of poisons into Bangladesh is permitted only under the
authority of a licence granted for the purpose by the relevant authority of
the Government.
 The Government, by making rules, regulates the possession and sale of
poisons, whether wholesale or retail.
 Rules under the Act provide for the grant of licences for the
possession and sale of any specified class of poisons.
 The rules also specify the classes of persons to whom the licences
for the possession and sale of poisons are to be granted, the
categories of persons to whom the poisons may be sold, maximum
quantity of any one poison that may be sold to a person, and provide
for the maintenance of a Register for the sale of poisons by the
persons who have been licensed to sell them.
 Rules are also specified for the safe custody of poisons and labelling
of the containers, coverings, etc. in which the poisons are stored or
sold.
Poisons Act, 1952
 Penalty of violators:
Violators of any of the provisions of the Act are liable to punishment with->>
• Imprisonment up to 3 months or to a fine up to Tk 500 or both on
first conviction, and with imprisonment up to 6 months or a fine up
to Tk 1,000 or both on any subsequent convictions.
• Any poison, in respect of which an offence has been committed,
is liable to confiscation together with all related materials.
However, nothing in the Act applies to anything used or done in
good faith, in the exercise of their profession, by medical or
veterinary practitioners. [Ref. Dr. Abdul Ghani; banglapedia.org]
[Ref. The Poison Act 1919;

& Dr. Abdul Ghani; banglapedia]
THE DRUGS (CONTROL) ORDINANCE, 1982
Ordinance No. VIII of 1982
>> AN ORDINANCE to control manufacture, import, distribution

and sale of drugs in Bangladesh
• This Ordinance was made and promulgated by the Chief Martial Law
Administrator of the People's Republic of Bangladesh on 11th June,
1982 as Ordinance No VIII of 1982. The provisions of this Ordinance are
additional to, and not derogatory of, the Drugs Act, 1940.
Through this Ordinance, the government has constituted :
(i)A Drug Control Committee consisting of a Chairman and a varied
number of members appointed by the government from time to time
to perform such functions as are specified in the Ordinance, and
(ii)A National Drug Advisory Council consisting of a Chairman and
such other members as the government may appoint from time to
time. The Council shall advise the Government on—
(a)measures to be adopted for the implementation of the national drug
policy that may be adopted by the Government from time to time;
(b)measures for the promotion of local pharmaceutical industries and
production and supply of essential drugs for meeting the needs of the
country.
(c)matters relating to the import of drugs and pharmaceutical raw
materials.
(d)measures for the co-ordination of the activities of the various Ministries,
agencies and persons dealing with manufacture, import, distribution and
sale of drugs.
Under this Ordinance,
i. No medicine of any kind can be manufactured for sale or be imported,
distributed or sold unless it is registered with the licencing authority;
ii. No drug or pharmaceutical raw material can be imported into the
country except with the prior approval of the licencing authority;
iii. The licencing authority cannot register a medicine unless such
registration is recommended by the Drug Control Committee;
iv. The licencing authority may cancel the registration of any medicine if
such cancellation is recommended by the Drug Control Committee on
finding that such a medicine is not safe, efficacious or useful;
v. The licencing authority is also empowered to temporarily suspend the
registration of any medicine if it is satisfied that such a medicine is
substandard;
vi. The government may, by notification in the official gazette, fix the
maximum price at which any medicine may be sold and at which any
pharmaceutical raw material may be imported or sold;
Under this Ordinance, Cont...

(vii) No person is allowed to manufacture any drug except under the
personal supervision of a pharmacist registered in Register 'A' of the
Pharmacy Council of Bangladesh;
(viii) No person, being a retailer, is allowed to sell any drug without the
personal supervision of a pharmacist registered in any Register of the
Pharmacy Council of Bangladesh; and
(ix) The government may, by notification in the official Gazette, establish
Drug Courts as and when it considers necessary.
Penalties for defaulters:

 There are provisions, under this Ordinance, of different kinds of
penalties (fines, imprisonment, withdrawal of registration,
cancellation of licences, etc) for defaulters of any of the above
regulations.
Penalties are explained from the Act as follows:

• Section 16. Penalty for manufacture, etc., of certain drugs.— Whoever
manufactures, imports, distributes or sells—
(a) any medicine which is not registered under this Ordinance, or
(b) any medicine in contravention of the provisions of section 8, or
(c)any drug which is adulterated or spurious. shall be punishable with
rigorous imprisonment for a term which may extend to ten years, or with
fine
which may extend to two lac taka, or with both, and any implements used in
the manufacture or sale of such medicine or drug may, by order of the Drug
Court, be forfeited to the Government.
• Section 17. Penalty for manufacture or sale of sub-standard drugs.—

Whoever manufactures or sells any sub-standard drug shall be punishable
with rigorous imprisonment for a term which may extend to live years, or with
fine which may extend to one lac taka, or with both.
• Section 18. Penalty for un-authorised import of drugs.— Whoever imports

any drug or pharmaceutical raw material without the prior approval of the
licencing authority shall be punishable with rigorous imprisonment for a term
which may extend to three years, or with fine which may extend to fifty
thousand taka, or with both and such drug or raw material may be order of
the Drug Court, be forfeited to the Government.
• Section 19. Penalty for sale of medicine or import or sale of pharmaceutical

raw material at a higher price.— Whoever sells any medicine or imports or
sells any pharmaceutical raw material at a price higher than the maximum
price fixed by the Government under section 11 shall be punishable with
rigorous imprisonment for a term which may extend to two years, or with fine
which any extend to ten thousand taka, or with both.
• Section 20. Penalty for theft, etc., of Government drugs.— Whoever

commits theft in respect of any drug in any Government store, hospital, clinic
or health centre or sells any such drug or keeps in his possession any such
drug for sale shall be punishable with rigorous imprisonment for a term
which may extend to ten years, or with fine which may extend to two lac taka
or with both.
• Section 21. Penalty for illegal advertisement and claims.— Whoever

contravenes the provision of section 14 shall be punishable with fine which
may extend to twenty-five thousand taka.
(Ref. The drugs (control) ordinance, 1982 Ordinance no. VIII of 1982
published in the Bangladesh gazette, extraordinary, dated the 12th june, 1982)
References
 The Pharmacy Ordinance, 1976, Ministry of Law and Parliamentary affairs,
Government of Bangladesh, Dhaka
 The Drugs (control) Ordinance, 1982, Ministry of Law and Land Reforms
Government of Bangladesh, Dhaka.
 Drugs, Poisons and Controlled Substances Act 1981
 National Drug Policy 1982
 The Drugs Act 1940
 Drug Policy of Bangladesh, Ministry of Health and Population Control, Health
Division, Dhaka. A Textbook of Forensic Pharmacy-B.M. Mithal
 The Directorate General of Drug Administration (DGDA)-Ministry of Health &
Family Welfare, Government of the People's Republic of Bangladesh.
Thank you for your attention

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COURSE TITLE: PHARMACY LAW AND ETHICS

COURSE CODE: BPH 3206

“The Art and Science of Manufacturing and Dispensing

Ethics is drived from Greek word “Ethos” means custom or

Pharmacy Law and Ethics

 It also incorporates other broad areas of law on pharmacy, such

 Pharmacist in Defense services (Army, Navy, Air-force)

e.g., Under the supervision of the Bangladesh Army, pharmacists

 Drug Regulatory Authority, under the Ministry of Health &

 It is an organization entrusted with the responsibility of

 Scope of and Function of PCB:

• In addition to this the pharmacy council performs the

Committees of the Council

 A Committee constituted under sub-section (1) may co-opt as its member

Accounts and audit:

(b) To prescribe the subjects in which approved examinations shall be held

(d) To prescribe the conditions and procedure for admission of candidates

(e) To lay down the standard of teaching to be maintained by institutions

(f) To prescribe the equipment and facilities to be made available to the

(h) To cause inspection of institutions which conduct any course of study in

(i) To prepare and maintain Registers of pharmacists and apprentices in

(j) To register pharmacists and grant certificates of registration

(k) To hold examinations for the purpose of registration as pharmacists and

(l) To do such other acts and things as it may be empowered or required to

(2) In particular and without 9[prejudice] to the generality of the foregoing

(b) The management of the property of the Council

(c) Maintenance and audit of the accounts of the Council

(d) The procedure for election of the Vice-President

(g) Fees to be prescribed under this Ordinance

b. Drug advertisement of any type is prohibited without prior approval of

c. With the prior approval of Drug Regulatory Authority, substantive, educational

11. Fixation of price of drugs.—

a. The government will regularly update the guidelines for control of

b. At least once a year drug prices will be updated based on the

c. Prices of Ayurvedic, Unani, Herbal, Homeopathic and Biochemic

d. Legal actions will be taken against person or establishments

Scheduling: A national classification system that controls how

 Medicines and poisons are classified into Schedules according

Poison or controlled substance means—

(1) The Minister may prepare a Poisons Code.

(2) The Poisons Code must contain—

• Furthermore, these patents apply for clinical trials long before to

TRIPS (Trade-Related Aspects of Intellectual Property Rights)

 National Drug Policy (NDP)

National Drug Policy of Bangladesh

(3) The combination of analgesics in any form is unacceptable as there is no, or

Impacts of National Drug Policy 1982

2. Availability of EMs also increased remarkably with the increase in the

3. Local companies increased their production share from 30% in 1970

4. Drug prices stabilized, increasing (practically a drop-in cost in real

6. The volume of imported drugs and medicine in the country reduced

7. Commendable progress occurred in the research, education, and

8. The less dependency on imports and prioritization of useful drugs

9. Bangladesh, a drug importing country, has become a drug exporting

 It was adapted in Bangladesh in 1974 vide Bangladesh Laws (Revision

Under this Act the government has constituted :

• A 'Drugs Technical Advisory Board‘: advises the government on

• The 'Drugs Consultative Committee' advises the Government and the

(Ref. The Drug Act, 1940 ;