COURSE TITLE: PHARMACY LAW AND ETHICS

COURSE CODE: BPH 3206

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 It was originally enacted by the Government of India on 10th April 1940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.
 THE DRUGS (CONTROL) ORDINANCE, 1982
Ordinance No. VIII of 1982
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.
 THE DRUGS (CONTROL) ORDINANCE, 1982
Ordinance No. VIII of 1982

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;
 THE DRUGS (CONTROL) ORDINANCE, 1982
Ordinance No. VIII of 1982

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.
 THE DRUGS (CONTROL) ORDINANCE, 1982
Ordinance No. VIII of 1982
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.
 THE DRUGS (CONTROL) ORDINANCE, 1982
Ordinance No. VIII of 1982
• 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.
 THE DRUGS (CONTROL) ORDINANCE, 1982
Ordinance No. VIII of 1982

• 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)
Thank you for your attention