Laws Regarding Drugs

1. Presented by: Mystics
PRESENTATION OF Business Law
Topic: Laws Regarding Drugs In Bangladesh

2. Mystics
Contents
National Drug Policy, 2005
The Drug Control (Ordinance), 1982
The Bengal Drug Rules, 1946
Drug Act, 1940

3. Mystics
Introduction
In order to remedy the deplorable situation that existed in
the drug and health sector of the country at the time of
independence and thereafter and to ensure adequate supply
and availability of good quality essential drugs at
affordable prices, a National Drug Policy (NDP) was
formulated in 1982. Following the guidelines of this BDP,
the Drugs (Control) Ordinance, 1922was also promulgated
in the same year be the then Government. These two
national documents. Which were highly applauded all over
the world, produced tremendous positive effects on rapid
development of the local Pharmaceutical industries and
gradual improvement and gains in the drug sector of the
country

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Diagram
•It extends to the
whole of
Bangladesh
•There have been
many drug house,
pharmaceutical
industry and user of
these drugs in all
over the
Bangladesh
•So the drug act is
enforced all over the
Bangladesh
Drug Act, 1940
•The Government
shall
constitute a Board
to advise the
Government on
technical matters
•The Board shall
consist of such
members including
a Chairman as the
Government
•The member of the
Board shall hold
office

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1. Drug Control
Committee
2. Prohibition of
Manufacture,
etc, of certain
medicines
3. Control of
advertisemen
t and claims
4. Penalty
1. Government
Analysis and
Inspectors
2. Sale of
Drugs
3. Manufacture
for
Examination,
Test or
Analysis
4. Labelling
and packing
1. Laws and
Regulations
2. Drug
Regulatory
Authority
(DRA)
3. Drug
Distribution,
Sale and
Storage
4. Drug Pricing
Laws Regarding Drugs In Bangladesh
Bengal
Drug
Rules,1946
Drug
Ordinance,
1982
Drug
Policy,
2005

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Laws and Regulation
1
Relevant Laws and
Regulations commensurate
with the prevailing
circumstances usually
control and regulate
production, distribution, sale
and use of drugs in a country
and ensure that they are of
good quality.
2
If the functioning of these laws
and regulations and their
compatibility with other laws,
either under the responsibility
of the Ministry of Health &
Family Welfare or other
Ministries and Departments,
affect implementation of the
different aspects of the NDP,
they should be amended
accordingly.

7. Drug Regulatory Authority
Drug Regulatory
Office location in BD
The Directorate General of
Drug Administration (DGDA)
under the Ministry of Health &
Family Welfare, Government of
the People's Republic of
Bangladesh, is the Drug
Regulatory Authority of the
country. A strong administrative
set-up is essential for effective
management of the various
aspects of the drug sector of a
country. The Directorate of
Drug Administration of
Bangladesh has a very limited
number of qualified technical
personnel and totally
insufficient infra-structure
facilities to effectively perform
the various functions of the
regulatory authority.

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Drug Distribution, Sale and Storage
Drug
Distribution,
Sale and Storage
No person without having
professional qualification
should be allowed to stock,
distribute or sell drugs and medicines
Only the drugs, which are
Registered in Bangladesh should
be allowed to be distributed
in the country.
No drugs or medicines,
other than
non-prescription (OTC) drugs,
should be sold or dispensed
without prescriptions
Maintenance of quality &safety of drugs in
Retail stores and in storage
should be by
Inspectors of drugs.

9. Mystics
Drug Pricing
Rational pricing of drugs should be
ensured to make
essential
drugs available to the end-users at affordable prices
The current system of controlling
prices of commonly
used essential drugs
should be continued
The existing system of linking prices
of the aforesaid locally produced drugs
cost should be revised
Drug Pricing

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Quality Assurance of Drugs and pharmaceuticals
1. One of the most important objectives of the
NDP is to make good quality drugs
available at affordable prices.
2. In order to achieve this objective, quality
building in a drug at the manufacturing
stage by in-process quality and quality
keeping in the drug in transit and storage
should be ensured by testing it at different
stages before it reaches the end-users.

11. Essential Drugs
 There shall be an Essential Drug List (EDL)
for Bangladesh. The directorate General of
Drug Administration in consultation with the
experts committee formed by the government
shall update from time to time and maintain
the list of essential drugs in line with the
current list of Essential Drugs of the World
Health Organization.

12. 6
7
8
9
10
Short List of Essential Drugs of BD
1
2
3
4
5
Amoxicillin
BCG vaccine
Chloroquine
Dopamine
Epinephrine (adrenaline)
Folic acid
Halothane
Insulin Inj. (Soluble)
Lithium Carbonate
11
12
13
14
15
Magnesium sulfate
Nitrous oxide
Paracetamol
Riboflavin
Zinc sulphate
Glucose

13. Drug Control
Committee
The Government shall
constitute a Drug Control
Committee consisting of a
Chairman and such other
members as it may
appoint from time to time.
The Committee shall
perform such functions as
are specified in this
Ordinance.

14. Prohibition of Manufacture,
etc, of certain medicines
 (1) On the commencement of this Ordinance, the registration or
license in respect of all medicines mentioned in the Schedules shall
stand cancelled, and no such medicine shall, subject to the
provisions of sub-section (2), be manufactured, imported, distributed
or sold after such commencement.
 (2) Notwithstanding anything contained in sub-section (1),—
(a) The medicines specified in Schedule I shall be destroyed
within three months from the Date of commencement of this
Ordinance;
(b) the medicines specified in Schedule II may be
manufactured or sold for a period of six months from the
date of commencement of this Ordinance
(c) The medicines specified in Schedule III may be
manufactured, imported, distributed and sold for a
period of nine months after the commencement of this Ordinance

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Drug Information Monitoring
A well-equipped Drug monitoring
and information Unit.
3.Rational use of drugs (RUD)
should be ensured
4.Monitoring and reporting of adverse
drug reactions (ADR) should be seriously done
Safety, efficacy and quality of all
registered drugs should be monitored
Add your text
Drug
Information
Monitoring

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Control of advertisement and claims in respect of drugs.
1.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 licensing authority
Explanation: ."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.

17. Penalty
Penalty for illegal
advertisement and claims2
Penalty for theft, etc., of
Government drugs4
Penalty for manufacture of
certain drugs31
Penalty for un-authorized
import of drugs33
Penalty for manufacture or
sale of sub-standard drugs35

18. Any medicine which is not
registered under this Ordinance
Any medicine in contravention
of the provisions of section 8
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
Penalty for manufacture, etc., of certain drugs
Whoever manufactures, imports, distributes or sells

19. 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
Whoever contravenes the
provision of section 14
shall be punishable with
fine which may extend to
twenty-five thousand
taka.
Penalty for illegal
advertisement and
claims

20. Penalty for un-authorized
import of drugs
Whoever imports any
drug or pharmaceutical
raw material without the
prior approval of the
licensing 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.
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.
Penalty for theft, etc.,
of Government drugs

21. 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.

22. National Drug Advisory
Council
1. The Government shall constitute a National Drug Advisory
Council consisting of a Chairman and such oilier members as
it may appoint from time to lime
2. 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.

23. Special Provision regarding Imprisonment & Fine
Notwithstanding anything contained in section 32 of the
Code of Criminal Procedure, 1898, it shall be lawful for any
Magistrate of the first class to pass any sentence authorized
by this Act even if such sentence exceeds his powers under
section 32 of that Code.
Explanation: An offender is usually charged with the most
serious offences that can be established on the facts of the
case. On representations being made by the offender's
lawyer to the prosecuting authority, the Prosecution may
agree to charge the offender with lesser offences provided
that he or she agrees to plead guilty to the reduced charges

24. The Drugs Technical Advisory Board
Title
The Government shall constitute a Board
to advise the Government
on technical matters
The functions of the Board may
be exercised notwith
standing any vacancy therein
The Board shall consist of
such members including a
Chairman as the
Government may, by
notification in the official
Gazette,
appoint such members
The member of the Board shall hold
office for such term as
the Government may fix
The Board may,make
by laws fixing a quorum
and regulating its own
procedure and the conduct
of all business to
be transacted by it

25. Standards of quality
For the purposes of
this Chapter the
expression
“standard quality”
when applied to a
drug means that the
drug complies with
the standard set out
in the Schedule
Standards
of quality
The Government
after giving by
notification in the
official Gazette
not less than three
months' notice of
its intention so to
do

26. Misbranded drugs
 If it is an imitation of, or substitute for, or resembles in
a manner likely to deceive, another drug, or bears
upon it or upon its label or container the name of
another drug, unless it is plainly and conspicuously
marked so as to reveal its true character and its lack
of identity with such other drug
 if it purports to be the product of a place or country of
which it is not truly a product
 if it is sold, or offered or exposed for sale, under a
name which belongs to another drug
 it is so colored, coated, powdered or polished that
damage is concealed, or if it is made to appear of
better or greater therapeutic value than it really is
 if it is not labelled in the prescribed manner

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