WORLD UNIVERSITY OF BANGLADESH

Department of Pharmacy
Course Title: Pharmacy Practice in Bangladesh
Course Code: PHR-805
Assignment on - “Drug and cosmetics act 2023”
Prepared By
Sabbir Ahmed Siddiqui (835)
Sumaiya Akter Mitu (836)
Sadia Tasnim (837)
Hasib Mir (838)
Sadia Akter Samia (839)
Sidratul Muntaha Ritu (840)

Submitted To
Sarder Arifuzzaman
Sr. Lecturer
Department of Pharmacy
World University of Bangladesh
 Drug and cosmetics act 2023

71.Control of advertisements and claims related to medicines and cosmetics. -

(1) No person shall, without the prior approval of the Licensing Authority,
publish or promote any such advertisement or advertisement which contains
any claim relating to the use or cure or treatment of drugs.
(2) Prohibition on the preparation, publication, or promotion of any
advertisement for cosmetics that contains false or misleading claims related to
the use or usage-related effects of cosmetics.

72. Prohibition of Unregistered Medicines. -

(1) No physician shall provide advice for the use of any medicine not registered
under this law to any patient.
(2) In cases of licensed import and use of such registered drugs, a physician may
provide advice on them, subject to the prior approval of the licensing authority.

73. Compliance with Decisions of the World Health Organization. —

The Ministry, if necessary, may follow the decisions of the World Health
Organization in matters of obtaining necessary decisions from the parties
included in the list of the World Health Organization.

74. Application of Narcotics Control Act, 2018. —

In the case of import, export, production, storage, and sale of any narcotic
substance or the raw material of a narcotic substance, the Narcotics Control
Act, 2018 (Act No. 63 of 2018) will be applicable.
75. Good Faith Work. —
If, in any work done in good faith under this law or regulation, any individual
is harmed or is likely to be harmed, no suit or proceeding shall lie against the
Ministry or any officer of the Ministry or any legal proceeding or suit under
any other law.

76. Authority to Make Rules. —

(1) For the purpose of carrying out the objectives of this law, the Government,
by notification in the official Gazette, may make rules:
Provided that any matter related to the production, distribution, import,
export, and determination and control of the quality of cosmetics shall remain
unaffected by this law or any other existing law or regulation until or unless, as
the case may be, an order is issued under this law, subject to any relevant
provisions under the law. Such matters shall only remain unaffected through
the respective authorities.

77. Government's Power to Resolve Ambiguity. —

If the Ministry encounters any ambiguity regarding its authority and
responsibilities as specified in this law, it may, by notification in the official
Gazette, issue directions concerning the duties of the Ministry with a
clarification or explanation of the relevant provision in accordance with this
law.

78. Collaboration and Assistance with Law Enforcement Agencies and Other
Organizations. —
For the purpose of achieving the objectives of this law, when necessary, any
organization or authority may, upon request from the Ministry, provide the
required cooperation and assistance, including the law enforcement agencies
and other relevant organizations or authorities.
79. Notification and Preservation of Seized or Detained Items. —
Any medicine, cosmetics, or related materials seized or detained under this law,
when detained or seized in the prescribed manner, a list of the detained or
seized goods will be provided to the relevant officer in writing, and the officer
in charge will immediately inform the superior officer by a written report and
will keep the seized or detained items at the designated location.

80. Receipt of Expert Opinion. —

(1) For the purpose of fulfilling the objectives of this law, when it is necessary
to receive a legal opinion or a professional analysis or opinion on a matter, the
Ministry may, if it believes in the transparency, expertise, or specialized
knowledge of the relevant matter, request one or more individuals with
transparency, expertise, or specialized knowledge to provide an opinion on the
subject matter or invite them to attend a meeting.
(2) The individual providing the opinion as mentioned in subsection (1) shall be
paid a designated fee, or as per government financial matters or policies,
appropriate remuneration or an honorarium.

81. Power to Make Rules. -

For the purpose of fulfilling the objectives of this law, the government may
amend the rules through a government gazette.
 Chapter XIV Abolition and Custody, etc.

82. Abolition and custody. -

(1) With the commencement of this Act, the Drugs Act, 1940 (Act XXIII of 1940)
and the Drugs (Control) Ordinance, 1982 (Ordinance No. VIII of 1982),
hereinafter referred to as such Act or Ordinance, shall be repealed.
(2) Notwithstanding the repeal under sub-section (1)
(a) Under the said Act or Ordinance, any declaration, order, direction, form,
letter, circular, approval, etc., made, issued, or provided in conjunction
with this law shall be deemed to be in conformity with the provisions of
this law and shall remain valid until revoked, amended, or reissued under
this law.
(b) If any act or proceeding under the said Act or Ordinance is pending
immediately before the commencement of this Act, such act or
proceeding shall be disposed of in accordance with the provisions of that
Act or Ordinance as if this Act had not been enacted.
(3) Notwithstanding the exemption under sub-section (1),
(a) Any license, registration, or marketing authorization certificate or any
work, facility, or prescribed activity issued, granted, provided, or
scheduled under this law by the licensing authority shall be considered.
(b) Uncompleted licenses or registrations, which were terminated in
accordance with the relevant provisions or regulations before the
enactment of this law, shall be terminated in the same manner.
(c) The revoked or temporarily suspended licenses, registrations, or any
facility or prescribed activity under this law shall be considered as
canceled.
(d) If any pending case or proceeding is incomplete or ongoing, it should be
concluded or continued in such a way that it is not exempt from the
provisions of the respective Act or Ordinance.
(e) It is considered that a Drugs Court has been established under the Drugs
Ordinance, which is not exempt from the provisions of this Act, and any
ongoing or pending cases in that court should be concluded in such a way
 that they are subject to trial by the Drugs Court established under this
Act.
(f) Any modified agreement or settlement, legal evidence, or instrument
shall remain in force in such a way that it has been concluded under the
provisions of this Act.
(g) The seized or confiscated drugs shall be preserved in such a way that
they are preserved under the provisions of this Act.
(4) The officials and employees who were appointed under the terms of
employment under the said Act shall continue to be employed under the same
terms unless modified or amended under this Act.
(5) Under the provisions of this Act or Ordinance, all kinds of loans, liabilities,
projects, and legal obligations of the government or the department shall be
considered as loans, liabilities, projects, and legal obligations of the
government or the department under the same terms as per the provisions of
this Act.

83. Publication of Dependable Text in English. -

(1) After the enforcement of this Act, the government can publish an authentic
English text by notification in the government gazette.
(2) In case of a conflict between the Bengali and English texts of this Act, the
Bengali text shall prevail.
 Schedule
[Section 2(14) Note]
Serial Clause Categories of offenses Punishment applicable for
Number the commission of a crime
(1) (2) (3) (4)
1. 14(1) If the drug is produced Imprisonment for a term
without a license or not exceeding 10 (ten)
without the conditions years or a fine not
imposed on the license. exceeding 10 (ten) lakh
taka, or both punishments.
2. 14(1) Displaying medicine for Imprisonment for a term
sale, storage, distribution, not exceeding 5 (five) years
or sale purposes outside or a fine not exceeding 5
the license or imposed (five) lakh taka, or both
conditions. punishments.

3. 14(2) Internet or web-based Imprisonment for a term

processes are used for the not exceeding 5 (five) years
purpose of selling, or a fine not exceeding 5
storing, distributing or (five) lakh taka, or both
selling medicines without punishments.
a license or without the
conditions imposed on
the license.
4. 14(3) By creating an artificial Life imprisonment or
shortage of medicines for imprisonment for a term
dishonest purposes, not exceeding 14 (fourteen)
medicines are stored with years or a fine not
the intention of greater exceeding 10 (ten) lakh
profit. taka, or both punishments.

5. 22(1) Production, import, Imprisonment for a term

export, sale, distribution, not exceeding 10 (ten)
storage, or display of years or a fine not
medicine without exceeding 10 (ten) lakh
registration. taka, or both punishments.
6. 30(4) Selling any medicine or Imprisonment for a term
raw material for the not exceeding 2 (two) years
production of medicine at or a fine not exceeding 2
a price exceeding the (two) lakh taka, or both
prescribed selling price. punishments.

7. 31(1) Production, distribution, Imprisonment for a term

import, or export of not exceeding 1 (one) year
cosmetics outside the or a fine not exceeding 1
license or imposed (one) lakh taka, or both
conditions. punishments.

8. 32(1) Production, distribution, Imprisonment for a term

import, or export of not exceeding 1 (one) year
cosmetics without or a fine not exceeding 1
registration. (one) lakh taka, or both
punishments.
9. 35(2) When using cosmetic Imprisonment for a term
applications of substances not exceeding 6(six) months
such as fillers, Botox, or a fine not exceeding 3
Glutathione, or similar (three) lakh taka, or both
products in the human punishments.
body through injections
or any other method,
excluding registered
doctors or as per their
regulations by the
Bangladesh Medical and
Dental Council (BMDC).
10. 35(3) When cosmetics are Imprisonment for a term
applied and used by a not exceeding 3(three)
beauty parlor in violation months or a fine not
of the law. exceeding 1(one) lakh taka,
or both punishments.

11. 36(1) If any such substandard Imprisonment for a term

medicine is produced, which may extend to
sold, stored, distributed, 7(seven) years or with fine
displayed or imported for not exceeding 10(Ten) lakh
the purpose of sale. taka or both.
12. 36(2) Provided that no claim Imprisonment for not less
for compensation shall lie than one (one) year or a
in respect of the sale of fine of 5 (five) lakh taka or
any sub-standard drug if both.
the seller proves that he
did not know, and could
not, with reasonable
diligence, have known,
that the drug sold was
sub-standard and that no
contravention of any
provision of this Act was
committed.
13. 37(1) Misbranded drugs are Imprisonment for a term
displayed for the purpose not exceeding 10 (ten)
of production, sale, years or a fine not
storage, distribution or exceeding 10 (ten) lakh
sale. taka, or both punishments.
14. 37(1) Misbranded cosmetics Imprisonment for a term
are displayed for the not exceeding 1(one) years
purpose of production, or a fine not exceeding 1
sale, storage, distribution (one) lakh taka, or both
or sale. punishments.
15. 38(1) If anyone manufactures Life imprisonment or
any counterfeit drug or imprisonment for a term
displays any counterfeit which may extend to 14
drug for sale, possession, (fourteen) years or with
distribution, or sale with fine not exceeding Ten
the intent to sell (ten) lakh taka or both.
counterfeit drugs
knowingly.
16. 38(1) If anyone manufactures Imprisonment for a term
any counterfeit cosmetics not exceeding five (5) years
or displays any or a fine not exceeding five
counterfeit cosmetics for (5) lakh taka, or both
sale, possession, punishments.
distribution, or sale with
the intent to sell
counterfeit cosmetics
knowingly.
17. 39(1) If the drug is adulterated Life imprisonment or
or any adulterated imprisonment for a term
medicine is produced, which may extend to 14
sold, stored, distributed (fourteen) years or with
or displayed for the fine not exceeding Ten
purpose of sale. (ten) lakh taka or both.

18. 39(1) If cosmetics are Imprisonment for a term

adulterated or any not exceeding five (5) years
adulterated cosmetics are or a fine not exceeding five
produced, sold, stored, (5) lakh taka, or both
distributed or displayed punishments.
for the purpose of sale.

19. 40(a) If government medicines Imprisonment for a term

are stocked or displayed not exceeding 10 (ten)
for the purpose of sale or years or a fine not
sale. exceeding 10 (ten) lakh
taka, or both punishments.
20. 40(b) If any medicine Imprisonment for a term
prohibited by the not exceeding one (1) year
government or expired is or a fine not exceeding fifty
stocked or displayed for (50) thousand taka, or both
sale or with the intent to punishments.
sell after the expiration
date.
21. 40(c) If a physician stocks or A fine not exceeding 10
displays for sale or with (ten) thousand taka.
the intent to sell any
national medicine
sample.
22. 40(d) Selling antibiotics or any A fine not exceeding 20
other medicine without (twenty) thousand taka.
the prescription of a
registered physician,
except for Over-the-
Counter-drugs.
23. 41(1) Importing medicines Imprisonment for a term
outside of the license or which may extend to ten
beyond the conditions (ten) years or with fine not
imposed by the license. exceeding Ten (ten) lakh
taka or both.

24. 41(2) Importing any registered A fine of not more than 10

drug contrary to the (10) lakh taka.
prior approval of the
licensing authority.

25. 42(1) Collecting locally the raw A fine of not more than 20
materials for the (twenty) thousand taka.
production of registered
drugs or packaging
materials for drugs,
contrary to the prior
approval of the licensing
authority.
26. 42(1) Importing raw materials A fine of not more than 10
for the production of (ten) lakh taka.
registered drugs or
packaging materials for
drugs, contrary to the
prior approval of the
licensing authority
27. 42(2) Importing any type of A fine of not more than 10
semi-finished drug or any (ten) lakh taka.
necessary ingredient or
component for the
production of drugs
contrary to the prior
approval of the licensing
authority.
28. 43(1) If any medicine is A punishment of
imported without a imprisonment for up to 3
license. (three) years or a fine of
not less than 1 (one) lakh
taka, or both penalties may
be imposed.
29. 48(2) If any inspector is A fine of not less than 3
obstructed during the (three) lakh taka.
exercise of the powers
conferred by this law or
the laws acquired under
it.

30. 52(6) If a report of any test and A fine of not less than 2
analysis provided by the (two) lakh taka.
National Control
Laboratory or drug
analyst or quotation of
that report is used as
advertisement.
31. 70 If any pharmaceutical A punishment of
product, especially any imprisonment for up to 2
medicine described as (two) years or a fine of not
allopathic, Unani, less than 50 (fifty)
Ayurvedic, homeopathic, thousand taka, or both
or biochemic, herbal, or penalties may be imposed.
any other pharmaceutical
specialty, is offered for
sale, distributed free of
charge, or proposed for
distribution in the public
domain, roads, highways,
sidewalks, parks, any
public transport, or any
vehicle for public use.
32. 71(1) If any such advertisement A punishment of
is published or imprisonment for up to 3
disseminated or (three) years or a fine of
participated in any not less than 5 (five) lakh
advertisement relating to taka, or both penalties may
the use or cure or be imposed.
medical claim of any
drug without the prior
approval of the licensing
authority.
33. 71(2) Any cosmetics A fine of not more than 3
manufacturer, importer, (3) lakh taka.
distributor, or seller
preparing, publishing, or
disseminating such
advertisements for
cosmetics containing
misleading or false claims
regarding the use or
consumer-related results.

K.M. Abdus Salam,

Senior Secretary.