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.

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