Course Title: Pharmacy Practice in Bangladesh

Course code: PHR-805

Assignment: Group-1
Assignment Topic "Drug and Cosmetics Act 2023".

Submitted By: Submitted To:

Md. Alif (Roll-797) SARDER ARIFUZZAMAN
sumaia Akter (Roll-798) Sr. Lecturer
Md. FAZLUL HAQUE (Roll-800) Department of Pharmacy
Imran Hossain (Roll-801) World University of Bangladesh
Shanjida Afrin Shorna (Roll-802)
Shabnaz Akter shila (Roll-803)
Mousumi Akter (Roll-807)
Sraboni (Roll:810)
Submission Date:25/10/2023
 Registered No. D A-1

Bangladesh Govt.
Bangladesh Gazette

Monday, September 18, 2023

Bangladesh National Parliament

Dhaka, 03 Ashwin, 1430 / 18 September, 2023

The following Act passed by Parliament vide 03 Ashwin, 1430 has received the assent of the
President on September 18, 2023 and this Act is hereby published for public information.

Law No. 29 of 2023

Production, import, export, purchase and sale, storage, storage, of medicines and cosmetics.

Drugs Act, 1940 and Drugs for the purpose of display, distribution and quality control

(Control) Ordinance, 1982 as amended by repeal

A law made for the purpose of enacting new laws

Since the production, import, export, purchase and sale, storage, storage, It is necessary to control
display, distribution and quality and to prevent criminal activities related thereto. And Since the
Drugs Act, 1940 (Act No. XXIII of 1940) and Drugs (Control)

Ordinance, 1982 (Ordinance No. VIII of 1982) repealed and updated

Legislation is expedient and necessary. Therefore it is hereby enacted as follows: -

Chapter-I
early

1. Short title and introduction. (1) This Act may be called the Medicines and Cosmetics Act, 2023

shall be called

(2) It shall take effect immediately. (13315) Price Rs.80.00

Bangladesh Gazette, Extra, September 18, 2023

definition. Unless there is anything contrary to the subject or context, in this Act—

2. (1) "Department" means the Directorate of Medicines Administration referred to in section 4;

(2) "standard value" means the standard value defined in section 36;

(3) "appeal" means the appeal referred to in sections 19, 27 and 64, as the case may be

(4) "manufacture" means any process or part or stage of preparing, altering, decorating, finishing,
packing, labelling, breaking up or otherwise treating or adapting any drug for the purpose of sale
or distribution;

(5) “medicine” means—

(a) Medicines of all kinds, including vaccines and biological medicines for internal or external use
in humans or animals, and all substances useful for treating and mitigating, curing or preventing
diseases in humans or animals.

(b) Medical devices.

(c) any substance other than food which may alter the constitution or bodily functions of the human
body and may cause disease in man or animal. Any substance useful for the destruction of vermin
or insects such as:

(b) any substance mentioned as a monograph in any edition of the British Pharmacopoeia, the
United States Pharmacopoeia, the United States National Formulary, the European Pharmacopoeia
or the International Pharmacopoeia;

(6) Any material used or prepared for use according to Unani, Ayurvedic herbal and homeopathic
and biochemical methods.

(f) Dietary Supplements, Herbal Supplements, Nutritional Supplements, Medical

NUTRITION OR THERAPEUTIC NUTRITION OR FOOD PRODUCTS OR SUPPLEMENTS.

and (g) for the purposes of this Act, any substance or substance declared by the Government by
notification in the Official Gazette to be a medicine.

explanation. This panchayat is mentioned

(b) "Dietary Supplement", "Herbal Supplement", "Nutritional Supplement", "Medical Nutrition",

"Therapeutic Nutrition", "Food Supplement" or "Supplemental Nutrients" means vitamins,
minerals, amino acids, herbs and botanical extracts other than tobacco. , prebiotics,
Bangladesh Gazette, Extra, September 18, 2023

Probiotics, symbiotics, pharmabiotics or preparations of single or combined ingredients of

enzymes, which are served in pharmaceutical dosage forms and which play a role in the prevention,
cure, body composition or function of human or animal diseases; And

(a) "biological medicine" means any such medicine, which contains any active ingredient produced
or extracted from a biological living system and which requires biological tests including
physicochemical tests;

(6) “Medicine Court” means the Medicine Court referred to in section 62:

(7) “Drug Control Committee” means the Drug Control Committee constituted under section 12;
(8) “Cosmetics” means rubbing (Rubbing), pouring (Pouring), spraying (Spraying),

or thereby effecting any physical change in the human body or human body

Cosmetic products claiming to be medicinal; (9) "Committee" means a committee referred to in

section 12, and includes sub-committees

will be (10) "company" means a company formed and registered under the Companies Act, 1994
(Act No. 18 of 1994);

(11) "Clinical trial" means the clinical pharmacological, pharmacodynamics, pharmacokinetics, or

bioequivalence test of a new medicine obtained by a systematic method in the human body or
animal body, through which the adverse reactions, safety, Efficacy and tolerability are determined.

explain Mentioned in this clause

(a) "bioavailability test" means the determination of the rate and amount of a drug in the human or
animal body that is present in the circulatory system;

(b) "bioequivalence test" means the determination of the extent and rate of absorption of the active
ingredient of a medicine compared to the rate and amount of absorption of the active ingredient of
a standard medicine under the same conditions and administration;

(12) "Good Manufacturing Practice (GMP)" means the manufacturing and quality control practices
of medicinal products as laid down in the World Health Organization guidelines:

(13) "drug analyst" means any drug analyst appointed under the provisions.
Bangladesh Gazette, Extra, September 18, 2023

(14) Schedule” means the Schedule to this Act.

(15) "counterfeit medicine" or "counterfeit cosmetics" means any medicine or cosmetics of the
nature mentioned in sub-section (2) of section 38;

(16) "registration" means under section 22 or 32, as the case may be, of drugs or cosmetics;

(17) “Sub standard” means not of standard standard.

(18) "prescribed" means by rules or until rules are made, the Government

With prior approval, as prescribed by the Directorate in written order

(19) "new drug" means—

(a) that the drug or the active ingredient of the drug is registered by the Licensing Authority;

No or not recommended by Medicines Control Committee. (b) different doses or different dosage
forms of the registered medicine, or

(c) Medicines consisting of fixed doses of several medicines already registered in different dosage
forms separately:

(20) "Laboratory" means the National Control Laboratory mentioned in section 10, and medicine

Laboratory shall also be included in it;

(21) "animal" means all mammals, birds, bees, reptiles other than human beings;

and other aquatic animals including fish and by the Government, notified in the Government
Gazette

Any other animal declared by

(22) “Pharmacovigilance means the contravention of a drug or any formulation thereof

Responses are related to identification, monitoring, evaluation, perception and prevention

Science and Activities. (23) “Pharmacist” means category 'A' in the Register of Bangladesh
Pharmacy Council;

Registered Pharmacist;

(24) “Criminal Procedure Code” means the Code of Criminal Procedure, 1898(Act No. V of 1898);
(25) “rules” means rules made under this Act;

(26) "advertisement" means any notice, leaflet, circular or document, displayed in any open place
or inside or outside public transport or published or circulated in any newspaper, periodical, radio,
television, online media or any other medium and any Announcements, whether presented orally
or by any other means of light or sound, and shall include any commercial circulars,
inserts and levels;

Bangladesh Gazette, Extra, September 18, 2023

(27) “person” means any individual, and any company, association, partnership;

It shall also include statutory or other bodies or institutions or their representatives.

(28) "adulterated medicine" or "adulterated cosmetics" has the meaning assigned to it in sub-
section (2) of section 39;

Any medicine or cosmetics of the aforesaid kind,

(29) "vaccine" means any antigenic material, which causes disease;

Prepared from microbes or alternative synthetic agents and which are one or more

Provides immunity to diseases.

(30) "Director-General" means the Director-General of the Directorate of Drug Administration,

(31) "marketing authorization certificate" has the meaning given under sub-section (2) of section
22;

Marketing Authorization Certificate:

(32) "Misbranded Drugs" or "Misbranded Cosmetics"

(Misbranded Cosmetics)" has the meaning specified in sub-section (3) of section 37 Any kind of
medicine or cosmetics

(33) “medical device” means—

(a) any instrument, apparatus, implement, machine, appliance, Implants, diagnostic reagents (in
vitro, in vivo and in silico reagent), software or similar or related products, which are single or

One or more of the following related to the treatment of humans or animals collectively
Used in -

(n) in the diagnosis, prevention, monitoring or treatment or alleviation of disease;

(a) detection of injury, monitoring damage mitigation or compensation (e) anatomy or

physiological process, search, replacement, modification

or (ii) in assisting to preserve life or vitality.

(g) As a birth control or deworming agent

Examination and analysis of samples collected from human or animal bodies. Through to pay

whose desired activity by pharmacological, immunological or metabolic action

does not take place and (b) any device and diagnostic reagent declared by the Government, by
notification in the Official Gazette, to carry out the purposes of this Act;

(34) "licence" means a medicine or cosmetics as mentioned in section 14 or 31, as the case may
be; license,

Bangladesh Gazette, Extra, September 18, 2022

Bangladesh Gazette, Extra, September 18, 2023

(35) "License Agreement" means for manufacture of medicine within Bangladesh

By the licensing authority of pharmaceutical manufacturing companies in Bangladesh

Issued licenses remain, including any domestic, foreign drug manufacturer

Contracts executed by the organization;

(36) "Licensing Authority" means the Director General.

3. Rule of law. Notwithstanding anything to the contrary contained in any other law for the time
being in force

Wherefore, the provisions of this Act shall prevail.

 Chapter-II
Directorate, Director General, National Control Laboratory, etc

4. Department of Drug Administration. To fulfill the objectives of this Act, the existing Medicines
Administration

The Department shall continue as if it had been established under this Act.

5. Office of the Directorate. - (1) The head office of the Directorate shall be situated in Dhaka.

(2) The Government may, if necessary, establish a branch office of the Directorate at any division,
district, upazila or any other place.

6. Functions of the Department. The functions of the Directorate shall be as follows, namely:-

(a) In relation to license of establishments manufacturing, selling, importing and exporting

medicines and in respect of licensing of establishments manufacturing, importing and exporting
cosmetics:

(b) Registration of Medicines and Certificate of Marketing Authorization and Registration of

Cometics

(c) Market supervision and regulation of medicines:

(d) manufacture, distribution, quality control, inspection, supervision and import of cosmetics and

(3) Implementation of pharmacovigilance activities

(f) inspection, supervision and control of establishments manufacturing and selling medicines and
cosmetics;

(g) Clinical trial approval and monitoring

(h) Taking necessary measures including monitoring the activities of drug laboratories

(or) activities relating to the release of lots of vaccines;

(a) Adoption of measures relating to standardization and control of medicines:

(k) perform any other duties assigned by the Government, from time to time; And

(l) taking any legal action necessary to carry out the above-mentioned functions.
Bangladesh Gazette, Extra, September 18, 2023

7. Director General (1) There shall be a Director General of the Department of Medicines
Administration.

(2) The Director General shall be appointed by the Government and his terms and conditions of
service by the Government

will be determined.

(3) The Director General shall be the whole-time officer and chief executive of the Department.

(4) If the post of Director General becomes vacant, or if the Director General is unable to perform
his duties due to absence, illness or any other reason, the Additional Director General of the
Department or appointed by the Government shall act until the newly appointed Director General
takes over the vacant post or until the Director General is again fit to perform his duties. A person
shall temporarily perform the duties of Director General.

8. Powers and functions of Director General. (1) The Director General shall manage all the
administrative and financial functions of the Department for the purposes of this Act and shall
exercise the powers, perform the duties and perform the functions assigned to him in accordance
with this Act and the Rules.

(2) Without prejudice to the provisions of sub-section (1) the Director General may from time to
time.

Perform assigned duties.

9. Delegation of powers.—The Director-General may exercise any of his powers or duties under
this Act,

If necessary, by written order, he can delegate to any employee in excess of it.

10. National Drug Control Laboratory, Pharmaceutical Laboratory, etc. (1) For the purpose of drug
quality control, there shall be a laboratory in Dhaka under the Directorate, which shall be called
National Drug Control Laboratory (NDCL).

(2) The laboratory referred to in sub-section (1) shall carry out the functions prescribed and
assigned by the Government and the Directorate, including testing, analysis, evaluation and
research related to medicine.
(3) of the Directorate at any place in Bangladesh other than the laboratory mentioned in sub-section
(1).

Required number of Drug Testing Laboratory (DTL) will be there.

(4) Functions and management of laboratories mentioned in sub-sections (1) and (3).

And the ancillary matters including the appointment of employees shall be determined by the rules.

11. Recruitment of employees. For the proper performance of the functions of the Department, the
Government may appoint the necessary number of employees as per the approved organizational
structure and their conditions of employment shall be determined by the relevant rules.

12. Constitution of Medicines and Cosmetics Control Committee and Subcommittee and
determination of scope, etc. —(1) The Government may, for carrying out the purposes of this Act,
by notification in the Official Gazette, constitute a committee to be called the Medicines Control
Committee and such number of other committees and sub-committees as may be necessary and
may prescribe their tenure, functions and ancillary matters.

Bangladesh Gazette, Extra, September 18, 2023

(2) The Government may, for the purpose of carrying out the purposes of this Act, by notification
in the Official Gazette, constitute a committee called the Cosmetics Control Committee and such
number of other committees and sub-committees as may be necessary and prescribe their tenure,
functions and ancillary matters.

13. National Medicines Advisory Council. (1) The Government, a Chairman and from time to time

It shall constitute a National Medicines Advisory Council consisting of such number of members
as it may deem fit.

(2) The National Medicines Advisory Council shall advise the Government on the following
matters, namely:

(a) Implementation of National Drug Policy formulated by Govt

(b) Development of domestic pharmaceutical industry and production and supply of medicines to
meet the needs of the country:

(c) for the purposes of clause (b), allopathic, Ayurvedic, Unani,

From homeopathic and biochemical and herbal and veterinary medicine

Declaring certain medicines as essential medicines and publishing the list

Update of said list every two years:

(d) Import of medicines and medicinal raw materials:

(3) Coordinating the activities of various ministries, government agencies and individuals involved
in the production, import, distribution and sale of medicines and

(f) any matter deemed necessary and incidental to the emergency.

(3) The Government shall, by notification in the Official Gazette, constitute the National
Medicines Advisory Council, term

He will determine the tasks.

Chapter-III
Medicinal license, etc

14. Obtaining license for manufacture, sale, storage, distribution or display for sale of medicinal
products. (1) No person or organization shall produce, sell, store, distribute or display medicinal
products for the purpose of sale without obtaining a license from the Licensing Authority or outside
the conditions imposed in the license.

Provided, however, that nothing in this clause shall, subject to the prescribed conditions, research,
analysis or

The production of small quantities of medicinal products for medical studies shall not be
applicable.

Provided further that, without the prior approval of the Licensing Authority, no new project or
expansion of an ongoing project for the manufacture of medicines shall be undertaken.

Bangladesh Gazette, Extra, September 18, 2023

(2) No person or organization shall use the internet or web based process for the purpose of
marketing, stocking, distributing or displaying any drug for sale without the license granted by the
licensing authority or outside the conditions imposed in the license.

(3) Any person or institution creating an artificial shortage of medicines for dishonest purposes

Medicines cannot be stockpiled for profit.

(4) Eligibility to obtain license, application for license and license renewal, approval and rejection
of application, license and license renewal fee and other related matters including license
conditions shall be determined by the rules.
Provided that the Government, from time to time, by notification in the Official Gazette, licenses
and licences

Renewal fee and, as the case may be, late fee may be rescheduled.

15. License validity and renewal. (1) The term of license shall be from the date of issue

2 (two) years and it shall be renewable.

(2) Not more than 90 (ninety) days before the expiry of the license, the provisions of this Act

Accordingly, application for license renewal shall be made to the licensing authority.

16. Procedure to be followed by the Licensing Authority for grant and renewal of licences: (1) The
Licensing Authority shall, for the purpose of grant or renewal of licences, inspect the premises of
drug manufacturing and selling establishments and grant licenses only in favor of such premises
as may be deemed suitable in accordance with this Act and Rules. or, as the case may be, renew
the license granted.

(2) Licensing power to grant or refuse applications for licenses and renewals of licences

It will be up to the authorities.

17. Good practices related to production and quality control, distribution, supply and storage of
medicines – (1) The organization manufacturing or selling medicines should follow the Good
Practices (GxP) guidelines of the World Health Organization in the production, quality control,
distribution or supply and storage of medicines.

(2) The government may formulate guidelines related to the production, quality control,
distribution or supply and storage of medicines by following the guidelines formulated by other
recognized international organizations including the World Health Organization.

18. Cancellation of license, temporary suspension, etc. (1) Licensing Authority

Cancellation of medicine license or, as applicable, suspension for any of the following reasons:

may, if the licensee (a) violates or contravenes this Act or the rules or any condition of the licence;

(b) Failure to manufacture the medicine following Good Manufacturing Practices (GMP).

(c) provides any false information or obtains a licence;

Bangladesh Gazette, Extra, September 18, 2023

(d) uses the license for any purpose other than establishing or operating a factory or establishment
for the purpose of manufacturing and processing medicine. (e) physical possession of the premises
of the concerned establishment without obtaining prior approval of the licensing authority

Change the infrastructure in a way that negatively affects the quality of medicine

affects or may: or

(f) does not comply with any prescribed conditions.

(2) Before canceling or temporarily suspending any license under sub-section (1), the licensing
authority shall issue a written reply, if any, notice to the concerned licensee specifying the reasons
and time limit.

(3) After receiving the written reply to the notice given under sub-section (2), if the said reply is
not satisfactory, the Licensing Authority may, after recording the reasons, cancel the license or
temporarily suspend the relevant license for such period as the Authority may think fit and
immediately stop the production of the medicine by the concerned establishment. .

(4) If the written reply referred to in sub-section (2) is satisfactory, the Licensing Authority shall
discharge the licensee from the charges brought against him. 19. Revision against orders of
temporary suspension of license and stoppage of production or

Appeal.——(1) License to a licensee under section 18 by the Licensing Authority

In case of temporary suspension and cessation of production of medicines of the concerned

establishment, the licensee, under

Application for reconsideration of the said order to the Licensing Authority within 30 (thirty)
working days

Or you can file an appeal with the government.

(2) In case of reconsideration or disposal of appeal referred to in sub-section (1), the authority
concerned shall give its decision after giving an opportunity of hearing to the parties concerned.

(3) In deciding the revision or appeal the licensing authority or, as the case may be, the Govt

The decision given by the shall be considered as final.

20. Production of medicines under license agreement, etc. (1) The Licensing Authority, under
license agreement executed with any drug manufacturing company in Bangladesh, may grant
permission to any foreign drug manufacturing company to manufacture drugs within Bangladesh
subject to necessary conditions for protection of public interest.

Provided, however, that before granting such permission, the Licensing Authority shall be satisfied
that any drug researched by the said drug manufacturing company is registered under the same
commercial name in any country as mentioned in sub-section (3) of Section 41.

(2) A drug manufacturing company in Bangladesh may be granted permission to manufacture

drugs under a written agreement with a drug manufacturing company of the same type.

------------------------------------------------------------------------------
End.
 Course Title: Pharmacy Practice in Bangladesh
Assignment, Week-12 Course Code: PHR-805
Topic: "Drug and Cosmetics Act 2023".

Submitted By: Group-2 Submitted To:

1. Sangeda Akter Jumu (Roll-811) SARDER ARIFUZZAMAN
2. Jannatul Ferdous (Roll-812) Sr. Lecturer
3. Mahabub Alam (Roll-813) Department of Pharmacy
4. Abdullah Sarker (Roll-814) World University of Bangladesh
5. Robiul Islam (Roll-815)
6. Sahanaj Parvin (Roll-816)
7. Kaniz Fatema (Roll-817)
8. Md. Hasibul Islam (Roll-820)

Submission Date: 26/10/2023

 Group-2

Registered No. D A-1

Bangladesh Govt.
Bangladesh Gazette

Monday, September 18, 2023

Bangladesh National Parliament

Dhaka, 03 Ashwin, 1430 / 18 September, 2023

(3) Foreign companies that do not have pharmaceutical manufacturing plants in Bangladesh for export
purposes only

Contract manufacturing or loan with self-discipline companies of all recognized formula drugs

Can produce under license (Contract Manufacturing or Loan License).

Provided, however, that the medicine manufactured shall in no way be marketed in the local market.

It can impose such conditions as it thinks fit.

(5) Licensing authority, notwithstanding anything contained in this section, prejudicial to public health

If deemed necessary to avoid any foreign drug manufacturer

may withdraw the approval granted in respect of the manufacture of any medicine.

Explanation. —In this section—

(a) “Loan Licence” means a license issued by the Licensing Authority in favor of any person or institution
which does not have its own facilities or facilities for the manufacture of medicine, but is owned by another
licensee for the manufacture of medicine;

Willing to take over drug manufacturing facilities or facilities and

(b) "Contract manufacturing" means a contract entered into by a pharmaceutical manufacturing company
in Bangladesh on its own with a foreign company having no pharmaceutical manufacturing plant in
Bangladesh for the manufacture of pharmaceuticals by approved methods for export purposes only.

21. Amendment of license agreement executed with foreign organizations.

(1) If any license agreement executed by a foreign organization with a Bangladeshi organization for the
manufacture of medicine within Bangladesh contains any provision against national interest, the licensing
authority,

May direct the organization to amend the relevant provisions of the agreement. (2) If the concerned
establishment fails to comply with the instructions given under sub-section (1), the licensing authority
may cancel the license granted to the said establishment for the manufacture of medicine.

Chapter IV

Drug Registration, Marketing Authorization Certificate, etc

22. Drug registration and marketing authorization certificate, etc. —

(1) Any person or Any type of medicine without obtaining registration from the institution, licensing
authority May not manufacture, import, export, sell, distribute, store or display.

(2) Notwithstanding anything contained in sub-section (1), the distribution, marketing and

Marketing Authorization Certificate should be obtained from Licensing Authority before sale.
(3) The Licensing Authority shall not register any medicine without the recommendation of the Medicines
Control Committee.

(4) Notwithstanding anything contained in sub-section (3), sudden calamity, outbreak of epidemic or

In case of public health and national emergencies to deal with calamities, upon the imposition of
prescribed conditions, without the prior recommendation of the Medicines Control Committee,
registration certificate of medicine may be issued, provided that the same is issued within 90 (ninety) days
after such registration. To be submitted for the recommendation of Control Committee.

(5) Eligibility for obtaining registration, application for registration and renewal of registration, approval
of application and The conditions of refusal and registration shall be determined by the relevant rules.

(6) Notwithstanding anything contained in sub-section (5), the licensing authority, of the registration of
medicines

may, where appropriate, impose such conditions as it deems fit in the public interest.

(7) To the organization applying for the registration and marketing authorization certificate of the drug.
Satisfactory information on the quality, safety and efficacy of the drug concerned shall be submitted as
required by the Licensing Authority. (8) No person or institution shall sell or distribute any medicine,

if not
The brand or generic name of the medicine is approved by the licensing authority remains.

(9) If a drug under a brand name is sold by more than one company, the ownership of the brand name
shall be vested in the company that obtained the registration first.

have to do

(10) Information regarding clinical trials or bioequivalence studies should be submitted in case of
registration of a specific medicine as per the requirement of the licensing authority.

(11) To prevent counterfeiting of certain medicines as required by the Licensing Authority

Manufacturing establishments shall follow special identification procedures.

(12) For the purpose of registration of homeopathic and biochemical medicines, if the Government, by
notification in the Government Gazette, specifies the pharmacopoeia of any such country, the licensing
authority shall follow the said standard in the country in which special standards have been adopted for
the methods of preparation and use of homeopathic and biochemical medicines. .

(13) For the purpose of registration of Unani, Ayurvedic and Herbal Medicines the Licensing Authority
shall follow such standards as may be specified by the Government.

23. Duration of Registration and Marketing Authorization Certificate.

(1) Registration of medicines shall remain valid and valid for 5 (five) years.

(2) Registration shall be renewable and not more than 90 (ninety) days before expiry

As per the provisions of law, application for renewal of registration has to be made. (3) Licensing authority
has power to grant or reject application for renewal of registration

Will remain vested. (4) The marketing authorization certificate shall likewise remain in force and effect
for as long as the registration of the medicine remains in force and effect.

24. Registration and registration renewal fees, etc.

(1) Registration and registration renewal fee of medicines and, as the case may be, late fee, as prescribed
by the Rules:

Provided that the Government may, from time to time, by notification in the Official Gazette, re-fix the
said fee

can do
(2) The licensing authority shall not register or, as the case may be, renew the registration of any medicine
unless the prescribed fee is paid in accordance with subsection (1).

25. Cancellation or suspension of registration —

(1) The Licensing Authority may cancel the registration of any medicine on the recommendation of the
Medicines Control Committee.

(2) Notwithstanding anything contained in sub-section (1), if the Licensing Authority is satisfied to this
effect. If any drug is of low quality, fake, misbranded or the facilities required for production are not up
to standard, the registration of the respective drug may be canceled, temporarily suspended or production
stopped and marketing suspended.

(3) The Licensing Authority shall, before canceling or temporarily suspending the registration of any drug
under sub-section (2), give notice to the person or institution concerned for submission of written reply,
if any, specifying the appropriate reasons and time limit.

(4) After receiving the reply to the notice given under sub-section (3), if the said reply is not satisfactory,
the Licensing Authority may, after recording the reasons, cancel the registration of the medicine concerned
or temporarily suspend the registration of the medicine concerned for such period as the Authority may
think fit.

can do (5) If the answer mentioned in sub-section (3) is satisfactory, the licensing authority shall exempt
the concerned person or institution from the charges brought against him and stop the production of the
medicine and

The order regarding suspension of marketing will be withdrawn.

26. Withdrawal from the market, destruction, cessation of sale or suspension of marketing, etc.

(1) In the event of cancellation or temporary suspension of registration of substandard drugs or drugs, the
licensing authority may issue necessary orders to withdraw the drug from the market and destroy it.

(2) If the use of a registered medicine results in an adverse reaction in man or animal or if any person or
animal dies as part of the reaction, the licensing authority shall forthwith, Until further orders, the sale and
marketing of the concerned medicine may be ordered to be suspended.

(3) Examination and analysis by the laboratory concerned after making an order under sub-section (2).

Confirmation of adverse reactions through reporting or any other means or procedures

Subject to the licensing authority withdrawing the said drug from the market and destroying it
If the order is given, the concerned institution shall destroy the medicine and inform the licensing authority
that will do

27. Revision or appeal against orders suspending registration and suspending manufacture and
marketing of medicinal products. —

(1) If the registration of any drug under section 25 is temporarily suspended by the Licensing Authority
and the production and marketing of the said drug is suspended, the concerned person or organization
shall within 30 (thirty) working days apply to the Licensing Authority for reconsideration of the said order
or appeal to the Government. can file

(2) In the case of the revision or disposal of the appeal referred to in subsection (1), the concerned authority
shall give its decision in the matter after giving an opportunity of hearing to the parties concerned. (3) the
Licensing Authority or, as the case may be, the Government during the disposal of the revision or appeal

The decision given by the shall be considered as final.

28. Duties and functions of the Medicines Control Committee with respect of registration of drugs
and cancellation or suspension of registration of drugs —

(1) The duties and functions of the Medicines Control Committee for carrying out the purposes of this
Chapter shall be as follows, namely: ---

(a) evaluation to determine the safety, efficacy, and utility of the drug concerned in recommending the
registration of a new drug; and

(b) in making recommendations for cancellation or temporary suspension of registration of drugs,

evaluating the safety, efficacy, and utility of registered or registrable drugs and the drugs that may be
manufactured or imported;

Evaluation for evaluation.

(2) After the evaluation under sub-section (1), if it appears to the drug control committee that it is safe,
useful or effective for the respective use, it shall make a recommendation to the licensing authority for the
registration of the medicine concerned, and if it appears that the medicine is not safe, useful or effective,
the said medicine Recommend to Licensing Authority for cancellation or suspension of registration.

29. Publication of list of registered medicines. The Department shall, on its website, publish the list
of registered medicines with prescribed information and update the said list from time to time.

30. Fixation of the price of drugs and raw materials of drugs —

(1) Government, notification in Government Gazette

may, under sub-section (2), fix the maximum retail price of listed and imported drugs.
(2) The Government shall, for the purposes of subsection (1), prepare and publish by notification in the
Government Gazette a list of the medicines for which the maximum retail price shall be fixed.

(3) The Government may, by notification in the Official Gazette, use in the manufacture of drugs any
country

May determine the maximum selling price of medicinal raw materials.

(4) Any person or establishment supplies medicine at a price higher than the price fixed under this section
or

Cannot sell raw materials for making medicines.

Chapter-V Cosmetics

31. License of cosmetics.

(1) Any person or institution to the Licensing Authority

Do not manufacture, distribute, import, or export cosmetics without obtaining a license from or outside
the conditions imposed by the license.

(2) Eligibility for obtaining the license, application for license and license renewal, approval or rejection
of application, license and license renewal fee, and other related matters including license conditions shall
be determined by the rules:

Provided that, till the rules are framed, the order with the prior approval of the Directorate, Govt.

May make necessary provisions in the said matter by issuance

Provided further that the Government may, from time to time, by notification in the Official Gazette,
license & License renewal fee and, as the case may be, late fee may be rescheduled.

32. Registration of cosmetics.

(1) No person or institution shall manufacture, distribute, import or export any type of cosmetics without
obtaining registration from the licensing authority.

(2) Eligibility for obtaining registration, applications for registration and renewal of registration, approval
and rejection of applications, registration and registration renewal fees and other related matters including
the conditions of registration shall be determined by the rules:

Provided that until such time as rules are made, the Directorate may, with the prior approval of the
Government, by issuing orders, make necessary provisions in the said matter Provided further that the
Government may, from time to time, by notification in the Official Gazette, provide for registration and
registration renewal fees and, as the case may be, delay Fees may be rescheduled.

33. Specializing in manufacturing, distribution, import and export, etc. of existing cosmetics

Provisions. — (1) Existing factories or business establishments concerned with the manufacture,
distribution, import, and export of cosmetics shall, within a period not exceeding 6 (six) months from the
date of the making of rules under this Act or, as the case may be, the issuance of orders, as the case may
be, licenses and registrations.

An application should be made to the licensing authority.

(2) On receipt of an application under sub-section (1) the licensing authority shall, as the case may be,
under section 31 or

Subject to the provisions of 32 will take measures to settle the relevant application.

34. Application and applicability of section 48. For the purposes of this Chapter, the provisions
relating to the powers of the Inspector in Chapter IX shall, so far as applicable, have the same effect
and applicability to the execution and execution of the provisions of Sections 31, 32, and 33.

35. Standardization, regulation, application, etc. of cosmetics.

(1) Government, of this Act.

In order to fulfill the objectives, standards, and regulation of cosmetics, laboratories, analysts and their
reports, advertising, and other matters incidental thereto including identification of misbranding, imitation,
adulteration and spurious shall be prescribed by rules.

However, provided that in determining the quality of cosmetics, the existing Bangladesh standards, and
EU, USFDA, ASEAN, and other international organizations and countries may follow the standards.

(2) No person other than a doctor registered by the Bangladesh Medical and Dental Council (BMDC) or
under the supervision of said doctor shall apply filler, botox, glutathione, or any similar cosmetics to the
human body by injection or otherwise.

(3) The Government may, by rules to prevent misuse and abuse of cosmetics in beauty parlors, make
necessary provisions regarding the application and use of cosmetics by beauty parlors.
 Chapter-VI

Standard quality of medicines and misbranded, fake and adulterated medicines or cosmetics, etc

36. Standard quality of medicine —

(1) No person or establishment shall manufacture, sell, stock, distribute, exhibit or import for sale any
medicine of inferior quality not of standard quality.

(2) No person shall, in respect of the quality of any medicine sold of such substandard quality, as the
proprietor or agent, guarantee to the purchasers that no harm will result from the consumption or use of
the said medicine and that no provision of this Act shall thereby be infringed.

(3) For the purposes of this section, standard standards mean—

(a) any medicine including Unani, Ayurvedic, Homoeopathic and Biochemical or Herbal medicine;

Standard standards prescribed by the Government in the field of medicine; and in the case of other drugs,
the standard set out in the latest 5 (five) editions of the Official Compendia or, in the case of no drug-
specific monographs available in the Official Compendia, the general standard set out in the Official
Compendia in the case of standardization.

explanation

Guidelines or specifications laid down by the inventing organization. In this clause "official compendia"
means the British Pharmacopoeia, the United States Pharmacopoeia, the United States National
Formulary, the European-

Pharmacopoeia or recognized International Pharmacopoeia.

37. Misbranded medicines or misbranded cosmetics. —

(1) Any person or institution

For the purpose of manufacturing, selling, storing, distributing, or selling misbranded medicines or
misbranded cosmetics can't be displayed.

(2) The Licensing Authority shall reserve the brand names of medicines and cosmetics and any

Will not approve brand names of misbranded medicines or misbranded cosmetics.

(3) For the purposes of this section any medicine or cosmetics shall be deemed to be misbranded,

(a) it is colored, coated, or polished in such a way that its damage is not apparent or it is made to appear
to be of a better or higher quality than it actually is;
(b) it is not labeled in the prescribed manner;

(c) mentions any description, design or device on its label or container or anything else concerned which
makes a false claim about the medicine or cosmetic or which is false or misleading in any particular
respect; and
(d) its brand name resembles or sounds similar to or appears similar to any existing brand name by which
the user of the said drug or cosmetic

There is a possibility of being cheated.

38. Fake medicine or fake cosmetics.

(1) No person or establishment shall manufacture counterfeit medicines or counterfeit cosmetics or

knowingly stock, distribute, or exhibit for sale any counterfeit medicines or counterfeit cosmetics.

(2) For the purpose of this section, the following drugs or cosmetics shall be deemed to be Counterfeit of
Falsified, or Spurious, if

(a) Impersonates any drug or cosmetic by means of the bottle, strip, foil, label, monogram, logo, etc. of
any popular drug or cosmetic for a dishonest purpose in such a way that outwardly the said drug or
cosmetic appears to be the original drug or cosmetic.

(b) it is a substitute for or similar to any other medicine or cosmetic, by which the public is likely to be
deceived;

(c) claims or purports to be a medicine or cosmetic in a place or country where it is not actually
manufactured;

(d) it is imported under any name, which in fact includes any other drug or cosmetic: or

(e) the name of any person, institution, or company is displayed on its label or container in such a manner
as to make the public believe that such person, institution, or company is the producer or manufacturer of
the drug or cosmetics, but in fact, such person, institution or company is Non-existent and fake.

39. Adulterated medicines or adulterated cosmetics. —

(1) No person or establishment shall manufacture, store, distribute, or exhibit for sale any adulterated
medicine or cosmetics or manufacture any adulterated medicine or adulterated cosmetics.

(2) For the purposes of this section, any medicine or cosmetics shall be deemed to be adulterated, which
is used or sold, or knowing that it may be sold or used, knowingly or dishonestly for the purpose of
obtaining unjust profit or for vandalism or any other dishonest purpose, any article, material or The
ingredients are so mixed or any of their essential substances, materials or ingredients are removed, so as
to reduce the effectiveness or alter the efficacy of the said medicine or cosmetics or in any other way cause
harm to it causing bodily harm or endangering life.

40. Restrictions on the sale of certain medicines. No person or establishment shall sell or, as
applicable, store or display for sale the following drugs:

(a) Government medicines:

(b) expired medicines and medicines banned by the Government;

(c) Medicines such as physician samples; or

(d) Antibiotics or any other medicine except over-the-counter medicine without a prescription from a
registered physician.

Chapter-VII

Restrictions on import and export of medicines

41. Restrictions on the import of medicines. —

(1) Exclusion of license or conditions imposed on license won't go

No medicine can be imported from abroad. (ii) Importing any registered medicine without the prior
approval of the Licensing Authority

(3) The Licensing Authority shall not, for the purpose of importation, grant registration or license of any
medicine for human or animal use, unless the said medicine is registered in those countries under the same
brand name. The list of countries is published by the government from time to time.

(4) Nothing in this section shall, subject to the conditions prescribed, examine, analyze, research or
personal

In case of importation of small quantities of medicine for use and any to meet national crisis

Not applicable in case of import of medicines.

(5) The Department may, in the case of registration of importable drugs, inspect the manufacturing
premises of the manufacturing establishment, if necessary, for verification of Good Manufacturing
Practice (GMP).
(6) All expenses related to the inspection referred to in sub-section (5) shall be incurred by the
Government
shall be paid at such rate as may be prescribed by rules or orders from time to time.

42. Restrictions on procurement and import of raw materials for drug manufacturing, packaging
materials of drugs, etc. —

(1) Raw materials for the manufacture of registered medicines or packaging materials for medicines, shall
not be locally procured or imported without the prior approval of the Licensing Authority.

(2) Without the prior approval of the Licensing Authority, any half for the manufacture of medicine

Import of ready (Semi Finished) medicines or any other essential material or materials won't go
(3) Directorate, raw materials for manufacture of importable drugs and packaging materials for drugs

In case of registration, for verification of Good Manufacturing Practices (GMP), the manufacturing
premises may be visited by the manufacturer, if necessary.
(4) All expenses related to the inspection referred to in sub-section (3) shall be borne by the Government,

shall, from time to time, pay such rates as may be prescribed by rules or orders.

43. Restrictions on the export of medicine without license.

(1) Granted by Licensing Authority

No medicine can be exported without a license.

(2) The licensing authority may, for the purpose of export, register any kind of medicine.

(3) Notwithstanding anything to the contrary contained in this section, the provisions of sub-sections (1)
and (2) shall apply to the export or shipment out of the country of any drug in small quantities for research,
analysis or personal use, subject to the permission of the Licensing Authority. no

Chapter-VIII

Supervision of qualified persons including pharmacists in the manufacture of medicines

44. Attendance and supervision of qualified persons, etc. in the manufacture of medicine —

(1) No person shall manufacture allopathic medicine without the close supervision of two qualified
persons of the institution mentioned in clauses (a) and (b), namely—

(a) a pharmacist and

(b) A person holding a Bachelor's or Master's degree with honors in Chemistry, Biochemistry, Applied
Chemistry, Microbiology, Pharmacology, Pharmacy, Medicine, Genetic Engineering or Chemical
Engineering from any University or Institute recognized by the Government.

(2) No person shall prepare Unani, Ayurvedic, Homeopathic, and Biochemical and Herbal medicines
without the direct supervision of two institutionally qualified persons referred to in clauses (a) and (b),
namely: -

(a) A Diploma holder with relevant Bachelor's Degree in Poisons from any University or Institute
recognized by the Government or having at least 01 (one) year of practical experience in pharmaceutical
production and quality control in related fields; And

(b) A person holding a Bachelor's or Master's degree with honors in Pharmacy, Chemistry, Botany,
Biochemistry, Applied Chemistry, or Microbiology from any University or Institute recognized by the
Government.

45. Supervision of competent person in the sale of medicine, etc. —

(1) Any person

A pharmacist as a retailer cannot sell allopathic medicines without the personal supervision of a
pharmacist, diploma pharmacist or pharmacy technician.
(2) Any person is a retailer of Unani, Ayurvedic unless under the supervision of a registered Unani
physician, Ayurvedic physician, pharmacist, diploma pharmacist, or pharmacy technician.

Or sell herbal medicine.

except

(3) No person shall sell medicines of homeopathic and biochemical methods under the personal
supervision of a registered homeopathic physician.

-------------------------------------------------------------------
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
MD Roni (821)
Md. Harun Or Rashid (825)
Laboni Akter Labonno (827)
Mominul Islam Soumik (829)
Lima Akter (830)
Md. Muhtashin Fuad (834)
Sadia Sarwar Azmi (833)
Mst. Sumiya Akter (832)

Submitted To
Sarder Arifuzzaman
Sr. Lecturer
Department of Pharmacy
World University of Bangladesh
 Drug and cosmetics act 2023: -
Chapter VIII: Supervision of qualified persons including pharmacist in the
production of medicines.

44.Presence and supervision of qualified persons in the production of

medicines, etc.-
1. No person shall prepare allopathic medicines without the direct supervision
of two persons of institutional qualification mentioned in clauses (a) and (b),
namely: -
(a) a pharmacist; And
(b) A person with a bachelor's or master's degree with honors in chemistry,
biochemistry, applied chemistry, microbiology, pharmacology,
pharmacy, medicine, genetic engineering or chemical engineering from a
university or institute recognized by the government.
2. No person shall prepare unani, Ayurvedic, homeopathic and biochemical and
herbal medicines without the direct supervision of two persons of institutional
qualification mentioned in clauses (a) and (b), namely: -
(a) A bachelor's degree in the concerned subject from a university or
institute recognized by the Government or a diploma holder with at least
one (one) year of practical experience in the production and quality
control of medicines in the concerned subject; And
(b) A person with a bachelor's or master's degree with honors in pharmacy,
chemistry, botany, biochemistry, applied chemistry or microbiology from
a university or institute recognized by the Government.

45. Supervision of a qualified person in the sale of medicines, etc.

1.No person shall sell allopathic medicines as a retailer without the personal
supervision of a pharmacist, diploma pharmacist or pharmacy technician;
2.No person shall sell medicines of Unani, Ayurvedic or herbal methods without
the supervision of a registered Unani doctor, Ayurvedic physician pharmacist,
diploma pharmacist or pharmacy technician registered as a retailer.
3.No person shall sell medicines of homeopathic and biochemical methods
without the personal supervision of a registered homeopathic doctor.
4.Notwithstanding anything contained in sub-sections (1), (2) and (3), the
wholesale sale of medicines shall not require the supervision of pharmacists,
diploma pharmacists, pharmacy technicians, registered Unani doctors,
Ayurvedic doctors or homeopathic doctors.
Explanation—Mentioned in this section
(a) "Diploma Pharmacist" means diploma pharmacist registered in 'B'
category in the Register of Bangladesh Pharmacy Council; And
(b) "Pharmacy Technician" means a pharmacy technician registered in 'C'
category in the Register of Bangladesh Pharmacy Council.

46) Information about qualified persons.

The licensing authority must provide updated information of qualified persons,
including pharmacists, diploma pharmacists and pharmacy technicians
engaged in the production and sale of medicines, to the concerned person or
organization to the licensing authority.

Chapter IX: -Appointment of inspectors, powers, etc.

47.Inspector. -
1.The Government may, by notification in the Official Gazette, appoint as
inspectors such qualified persons as it deems fit for the purposes of this Act.
Provided, however, that no person shall be appointed as an inspector if his
financial interests are related to the production, import, export, sale or
marketing of medicines and cosmetics.
2.Each inspector shall be deemed to be a public servant in the sense in which
the expression public servant is used in Section 21 of the Penal Code (Act XLV
of 1860). I
48. The power of the inspector. -
1. For the purposes of section 47, in the manner prescribed by each inspector,
in the local jurisdiction prescribed by the licensing authority and with the
permission of the licensing authority, in an area or jurisdiction other than that
jurisdiction,
(a) Inspect and verify the place of production of any medicine and cosmetics,
the plant and production capacity of production, the production process,
the materials used for standardization and testing and analysis of the
prescribed standards, and the records and registers therewith.
(b) Inspect the archives and related records of imported raw materials and
wrappers and imported medicines and cosmetics for the production of
medicines and cosmetics;
(c) Inspect the place of sale of any medicines and cosmetics or the place of
storage, display or distribution for the purpose of sale and the
arrangements for storage and related records and registers.
(d) Collect samples of any medicines and cosmetics that are produced, sold
or stored or displayed or distributed for sale.
(e) If it appears that any offence has been committed, committed or likely to
be committed in any building or place or in any vehicle of the hall, water
or air, in accordance with this Act or rule, the concerned building, place
or vehicle may enter and search the concerned building, place or vehicle
at reasonable time, taking such assistance as may be necessary from the
appropriate authority or law enforcement agencies, and the relevant
medicines, seize or seize cosmetics and other related items;
(f) During the search for or seizure under this Act or rule and during the
investigation of the offence committed in accordance with this Act or rule,
any person from the nearby area may be summoned to be present on the
spot as a witness.
(g) Summon any person to appear before him at an appropriate place at a
reasonable time to make a statement, assistance or information about an
offence committed in accordance with this Act or rules: Provided,
however, that the provision of exemption referred to in sections 132 and
133 of the Code of Civil Procedure, 1908 (Act No. V of 1908) shall apply
to summons for attendance under this clause.
(h) in any factory, laboratory, shop, pharmacy, building, storage or
warehouse, where medicines and cosmetics are being produced, sold,
 stored or distributed for sale without obtaining the necessary license
under this Act, or where any offence under this Act has been committed,
committed or is likely to occur, shall be locked and sealed;
(i) impose restrictions on the removal of any medicine, cosmetics or goods
from any place of production for a reasonable period of time, not less
than three (3) months, its medicines, cosmetics and other related goods
or any such medicine, cosmetics or goods which may be used as evidence
of any offence under this Act or rule;
(j) Exercise all or any such powers as may be relevant for the purposes of
this Act or rule.
2.No person or institution shall prevent the inspector from exercising his
powers under sub-section (1).
3.In the case of searches, seizures and detentions conducted under this Act, the
relevant provisions of the Code of Criminal Procedure shall apply, subject to
conformity with the provisions of this Act.

49. Opening of the place for the production, storage, sale, distribution, etc. of
medicines and cosmetics-
Every person in charge of the place of production, storage, sale and distribution
of medicines and cosmetics shall, if directed by the inspector for the relevant
period, be obliged to open the place of production, storage, sale or distribution
to the inspector.

50. Procedure to be followed by inspector:

1.If an inspector seizes any medicine, cosmetics or other items under this
chapter, he shall provide a copy of the prescribed form to the person from
whom the said medicine, cosmetics or other goods will be seized.
2.If an inspector collects a sample of medicines or cosmetics from a pharmacy,
shop or institution for the purpose of examination and analysis, he shall inform
the person from whom the sample is collected from the concerned pharmacy,
shop or institution, in the prescribed form and manner, and in his presence the
inspector shall divide the sample into four parts and sign and seal each part of
it and give the signature and identity of the person who gave the sample.
Provided, however, that if the person giving the sample is absent or absconding
at the time of collection of the sample or refuses to sign the sample and form
even if he is present, the inspector shall confirm and seal the matter by signing
himself in the presence of two witnesses;
It is further provided that if any institution is closed or sealed at the time of
sample collection, the inspector may, taking the help of that institution, the
officer-in-charge of the concerned nearby police station or the concerned
department or authority, openly collect the sample in the manner described in
this sub-section;
Provided further that, if necessary, the Inspector may, if necessary, examine
and analyze the sample in the approved scientific manner for the purpose of
preliminary examination before extracting the full sample described in this
subsection.
3.If a sample of any medicine or cosmetics is collected from the manufacturing
company or depot, the sample collected shall be divided into only three parts
and in that case shall be given to the person or institution referred to in clauses
(a), (b) and (d) of sub-section (5).
4.If an inspector fails to collect a sufficient number of samples of medicines or
cosmetics and it is absolutely necessary to collect samples of the relevant
medicines or cosmetics, without the division referred to in sub-sections (2) and
(3), subject to the permission of the Director General, collect and identify and,
if necessary, seal the number of samples that may be collected.
5.The inspector, under sub-section (2), after collecting and dividing a sample of
a medicine or cosmetics, shall supply its parts to the following persons or
institutions for the purpose or reason, namely:
(a) Part I: for the purpose of storing the sample with the person providing
the sample;
(b) Part II: for the purpose of testing and analysis before the drug analyst or,
in the field, the analyst;
(c) Part III: for the purpose of sending to the manufacturer, importer,
marketer or guarantor, if any;
 (d) Part IV: for the purpose of presenting it to the trial court;
Explanation: For the purposes of this chapter, the meaning of 'other materials'
shall include the equipment used in the production, including registers, receipt
books, invoice receipts and bills, which may be considered evidence of the
commission of an offence.

Chapter X Drug Analyst, etc.

51. Drug Analyst –

The Government may, by notification in the Official Gazette, appoint such
qualified person as it deems fit as drug analyst in the place or jurisdiction
mentioned in the notification for the examination and analysis of any class of
drugs.

52. Report of the Drug Analyst-

1.If the sample of the drug is sent to the drug analyst in accordance with clause
(b) of sub-section (5) of section 50 for testing and analysis, he shall sign three
copies of the report prepared in the prescribed form and send it to the
concerned inspector.
2. Upon receipt of the report referred to in sub-section (1), the Inspector shall
store a copy of the report for use in any case relating to the sample and shall
send the remaining copies to the sample provider and to the manufacturer,
importer, marketer or guarantor, if any.
3. If a person appeals to the trial court with evidence against the report of the
drug analyst, the court may, if necessary, send the sample stored to the
inspector under sub-section (2) for re-examination and analysis and the drug
analyst shall re-examine and analyze the sample by the National Neon
Laboratory and submit it to the court in the form of a report.
4. The report received under sub-section (3) shall be considered as final
evidence before the court.
5. The cost of testing and analysis by the National Control Laboratory under
sub-section (3) shall, as directed by the court, be paid by the accused person.
6. Reports received under sub-section (1) may not be used as advertisements by
any person or organization.

53. Right to report drug testing and analysis. -

If any person applies for the examination and analysis of any medicine
purchased or imported, exportable or produced by him, by paying the
prescribed fee, in the prescribed form, to the licensing authority or through the
inspector, he shall be entitled to receive the report of the examination and
analysis signed by the drug analyst on the basis of that application.

Chapter XI Crime, Prosecution, Investigation and Trial:

54. Punishment for violating the provisions of this Act. -

Any person who commits any act referred to in column (3) in accordance with
the section mentioned in column (2) of the Schedule shall be deemed to be an
offence under this Act and shall be punished with any or both of the penalties
mentioned in column (4) for that offence.

55. Confiscation. -
If any person is convicted by the appropriate court for violating any provision
of this Act or rule, the medicine or cosmetics in which this Act or rule has been
violated, the medicines or cosmetics, stores, machinery, goods, equipment or
the drugs or cosmetics or the ingredients and materials for making such
medicines or cosmetics shall be confiscated by the court.

56. Punishment for repeating a crime. -

If a person convicted of any of the offences mentioned in this Act commits the
same offence again, he shall be punished with twice the maximum punishment
prescribed under this Act for the offence concerned.

57. The commission of a crime by the company. -

1.If an offence under this Act is committed by a company, such owner, director,
executive officer, manager, secretary, partner or any other officer or employee
of the company who has a direct involvement in the said offence shall be deemed
to have committed the offence unless he can prove that the offence has been
committed without his knowledge and has done his best to prevent it.
2.If any offence under this Act is committed by a company, if it is proved that
the offence has been committed with the consent or connivance of any owner,
director, manager, secretary, partner or any other officer or employee of that
company or by their negligence, then the owner, director, manager, secretary,
partner or concerned officer or employee shall be deemed liable and shall be
liable accordingly.

58. Investigating and investigating officer. -

1.Without prejudice to the substance of section 61, the employee empowered by
the Director General, or the inspector engaged in the local jurisdiction may,
within the prescribed procedure and time limit, investigate any complaint
referred to in column (3) of the schedule as the investigating officer.
2.While conducting the investigation of any complaint under this Act, the
investigating officer may exercise the same powers as the officer-in-charge of
the police station in accordance with the provisions of the Code of Criminal
Procedure.
3.During the investigation under sub-section (1), the investigating officer may,
if necessary, seek assistance from any other agency or authority, including the
law enforcement agencies, and if such assistance is sought, the law enforcement
agencies and such agency or authority shall be obliged to provide the necessary
assistance.
59. Notability of crime and bailability.-
Notwithstanding anything contained in the Code of Criminal Procedure,
column (1) of the Schedule states:
(a) In accordance with the provisions stated in column (2), the offenses
mentioned in column (3) against serial numbers (2, 3, 6, 7, 8, 9, 10, 12, 14,
16, 18, 20, 21, 22, 24, 25, 26, 27, 28, 29, 30, 31, 32, and 33) shall be
punishable and liable to prosecution.
(b) And, as per the provisions mentioned in Column (2) opposite to serial
numbers 1, 4, 5, 11, 13, 15, 17, 19, and 23, the offenses listed in Column
(3) will be punishable and non-bailable.

60. Criminal prosecution. -

Notwithstanding anything contained in the Code of Criminal Procedure, no
court referred to in sub-section (2) of section 61 shall take for trial any offence
punishable under this Act without a written report from the Director General
or any officer empowered by him.

61. Investigation, prosecution, etc. of crimes. -

1.The Code of Criminal Procedure shall apply to other matters relating to the
investigation, trial and arrest or detention of offences committed under this Act.
2. Notwithstanding anything contained in the Code of Criminal Procedure,
referred to in column (1) of the Schedule
(a) Offenses described in Column (3) under the provisions mentioned in
Column (2) opposite serial numbers 1, 4, 5, 11, 13, 15, 17, 19, and 23 shall
be tried by a Special Drug Court; And
(b) The offenses described in column (3) under the section mentioned in
column (2) shall be adjudicated by the Chief Judicial Magistrate or
Special Magistrate or, as the case may be, the Chief Metropolitan
Magistrate or Special Metropolitan Magistrate, for serial numbers 2, 3,
 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 21, 22, 24, 25, 26, 27, 28, 29, 30, 31, 32, and
33.

62. Drug court. -

1.For the purposes of this Act, there shall be a court called a drug court at each
district headquarters to try the offences referred to in clause (a) of sub-section
(2) of section 61.
2.Notwithstanding anything contained in sub-section (1), the Government may,
if necessary, establish more than one drug court in a district and determine
local jurisdiction.
3.A drug court shall consist of a judge and the Government, in consultation
with the Supreme Court, shall appoint judges of that court from among the
district and sessions judges.
4. Notwithstanding anything contained in sub-section (3), the Government may,
if necessary, appoint a District and Sessions Judge as a Judge of a Drug Court
in addition to his duties. Explanation. "District and Sessions Judge" in this
section shall include "Additional District and Sessions Judge".

63. Enforcement of the Mobile Courts Act, 2009. —

Notwithstanding anything contained in any other law currently in force, in the
case of offences committed under this Act, subject to the schedule of the Mobile
Courts Act, 2009 (Act No. 59 of 2009), mobile courts may impose penalties.

64. Appeal. -
1.A drug court or chief judicial magistrate or special magistrate or, as the case
may be, a person aggrieved by an order, judgment or imposed by the chief
metropolitan magistrate or special metropolitan magistrate may appeal against
the order, judgment or sentence imposed, within not more than thirty (30) days
of the issuance of the relevant order, judgment or sentence, to the court
prescribed under the Code of Criminal Procedure.
2.Section 13 of the Mobile Courts Act, 2009 shall be followed in the appeal
against the sentence imposed by the Mobile Court.

Chapter XII Clinical Trials of Drugs, Pharmacovigilance, Vaccine Lot Release,

etc.

65. Pre-clinical trials, clinical trials, field trials, performance trials,

biocompatibility and bio-equalization studies of medicines, vaccines and
medical devices.
1.Subject to the approval of the licensing authority, contract research
organizations may be conducted for pre-clinical trials, clinical trials, field trials
or performance trials and biocompatibility or bio-equalization studies of
medicines, vaccines and medical devices.
2.Notwithstanding anything contained in sub-section (1), pre-clinical, clinical
field trials or performance trials and bio-compatibility studies or bio-
equivalence studies shall not be conducted by the Contract Research
Organization on any medical product, including drugs, vaccines and medical
devices used in the treatment of humans or any animal, without obtaining
protocol approval from the licensing authority.
3.If any activity is carried out by the Contract Research Organization without
the approval and protocol approval of the licensing authority referred to in sub-
sections (1) and (2), the licensing authority may stop the activity and impose the
prescribed administrative penalty.
4. In conducting the functions referred to in sub-section (1), the Good Clinical
Practice (GCP) guidelines approved by the Government or the guidelines
published by the World Health Or recognized International Standards Agency
shall be followed.
5.The Licensing Authority may, from time to time, inspect the pre-clinical,
clinical, field trial or performance trial and bio-compatibility study or bio-
equivalence study mentioned in sub-section (2).
6.To ensure the safety and rights of participants in clinical trials, the
Institutional Ethics Committee (IEC), Institutional Review Board (IRB) and
Animal Ethics Committee (AEC) shall be constituted by the Contract Research
Organization, subject to the approval of the licensing authority.
7.If any risk arises to the participants during the clinical trial, the licensing
authority may temporarily or permanently stop the relevant activities.
8.Approval of the Department shall be obtained for the import of
investigational medical products and for sending any samples collected from
the trial participants abroad for testing and analysis.
9.The Department may receive information or approved data relating to
clinical trials received from foreign pharmaceutical authorities.
10.The Department may, in the case of emergency health care or new medicines
for epidemic diseases, approve first-track clinical trials, subject to government
approval.
Explanation. "Contract Research Organization" referred to in this section
means any organization or organization that assumes or operates pre-clinical
trials, clinical trials, field trials or performance trials and biocompatibility or
bio-equivalence studies as per its requirements under an agreement entered
with any person or organization.

66. Pharmacovigilance —
1.For monitoring the side or adverse effects of medicines in humans or animals,
drug manufacturers, importers and marketing institutions, hospitals, clinics,
public health programs related institutions and other related institutions and
stakeholders must send reports and information to the licensing authority,
including conducting pharmacovigilance activities.
2. In carrying out the functions referred to in sub-section (1), the National
Pharmacovigilance Guidelines or Good Vigilance Practices approved by the
Government, or the guidelines published by the World Health Organization or
recognized international standards agency shall be followed.
3. The Licensing Authority shall, from time to time, monitor and inspect the
pharmacovigilance activities referred to in sub-section (1).
4. If the pharmacovigilance activities are not carried out effectively, the
licensing authority may temporarily suspend or cancel the license of the
production or import of medicines of the concerned organization or the
registration of any medicine.

67. Vaccine lot release. -

1.The lot release certificate of all human vaccines produced and imported in the
country shall be obtained from the licensing authority;
Provided, however, that the relevant lot may be released on the basis of the lot
release certificate of the country producing the vaccine pre-qualified by the
World Health Organization and supplied through any UN agency.
2.A particular vaccine may be marketed or supplied without lot release, subject
to the prior approval of the licensing authority, subject to the prior approval of
the licensing authority, considering the importance of public health
emergencies or the circumstances of a disaster or sudden disaster, the lack of
time and the urgent need for use;
Provided, however, that a lot release certificate must be obtained from the
licensing authority later.
3. In case of import of small quantities of vaccines for research or personal use,
a no-objection certificate may be obtained from the licensing authority in lieu
of a lot release certificate.

68. Formulation of policies or guidelines, etc. —

The Government may, for the purpose of this Act, make necessary policies or
guidelines by issuing administrative orders or notifications and determine the
scope of its functions, including the formation of a cell or committee.

Chapter XIII General and Miscellaneous

69. Administrative measures to be taken by the Department. —

1. If there is any unlawful activity related to medicines and cosmetics under this
Act, and any official or officer having authority, believes that a criminal offense
is being committed in contravention of columns (1) mentioned under serial
numbers 6, 7, 8, 9, 10, 14, 16, 18, 20, 21, 22, 25, 30, 31, 32, and 33, opposite to
column (2) referred to herein, he may, after considering, not take any action
against the guilty person except to impose a fine and to temporarily or
permanently suspend the related administrative arrangement in relation to the
business operation.
2. In the case of imposition of penalty in the administrative system under sub-
section (1), a fine shall not be imposed in excess of the maximum amount
prescribed under this Act for the offences concerned.
3. No fine imposed in the administrative system under sub-sections (1) and (2)
shall be imposed with non-payment of imprisonment.
4. The fine imposed under this section shall be paid to the guilty person
voluntarily within five (5) working days.
5. If the guilty person does not voluntarily pay the fine imposed under the
provisions of sub-section (4), the imposing authority may collect the fine
amount through croc and sale in accordance with the procedure described in
clause (a) of sub-section (1) of section 386 of the Code of Criminal Procedure
and may recover 25 percent of the fine imposed as additional expenses.

70. Restrictions on the sale of medicines in the way of public movement. -

No person shall propose to sell, distribute or distribute any medicine of
allopathic, Unani, ayurvedic, homeopathic and biochemical, herbal or any
other description of pharmaceutical specialty on public transport, highways,
footpaths, parks or any public transport or any vehicle.

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.
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.