The Drugs and Cosmetics Act, 2023

(Act No. XXIX of 2023)

An Act to enact new Act to regulate the manufacture, import, export, sale-purchase, stock,

preservation, exhibition, distribution and quality of drugs and cosmetics by repealing the Drugs

Act, 1940 and the Drugs (Control) Ordinance, 1982

WHEREAS it is expedient to regulate the manufacture, import, export, sale, storage, display,

distribution and quality of drugs and cosmetics and to prevent criminal activities in connection

therewith: and

Whereas it is expedient and necessary to enact new Act by repealing the Drugs Act, 1940

and the Drugs (Control) Ordinance, 1982;

It is hereby enacted as follows: -

CHAPTER I
Preliminary

1. Short title and Commencement. — (1) This Act may be called the Drugs and Cosmetics Act,

2023.

(2) It shall come into force at once.

2. Definitions. —In this Act, unless there is anything repugnant to the subject or context—
1. “Directorate” means the Directorate General of Drug Administration ‍as mentioned in

section 4;

2. “Standard quality” means the standard quality as defined in section 36;

3. “appeal” means appeal mentioned in sections 19, 27 and 64, as the case may be;

4. “manufacture” means any process or part or stage of process for making, altering,

ornamenting, finishing, packing, labeling, breaking up or otherwise treating or adapting any

drug with a view to its sale and distribution;

5. “drug” means—

a. all medicines for internal or external use of human beings or animals including

vaccine and biological medicine, and all substances intended to be used for or in the

treatment, mitigation, cure or prevention of diseases in human beings or animals;

b. medical devices;

c. such substances, other than food, intended to affect the structure or any function of

the human body or intended to be used for the destruction of vermin or insects

which cause disease in human beings or animals;

d. any substance, mentioned as monograph in any of the editions of the British

Pharmacopoeia, the United States Pharmacopoeia, the National Formulary of the

United States, European Pharmacopoeia or the International Pharmacopoeia;

e. any substance used or intended to be used in the Unani, Ayurvedic, Herbal and

homoeopathic or Biochemic system of medicine;

f. dietary supplement, herbal supplement, nutritional supplement, medical nutrition

 or therapeutic nutrition or food support or supplementary food support; and

g. any other thing or substance which the Government may, by notification in the

official Gazette, declare to be a “drug” for the purposes of this Act;

Explanation.

(i) “dietary supplement”, “herbal supplement”, “nutritional supplement”, “medical nutrition”,

“therapeutic nutrition”, “food support “or “supplementary support” mentioned in this clause

means vitamins, minerals, amino acids, herbs

and botanical extract other than tobacco, prebiotic,

probiotic, symbiotic, pharm abiotic or materials made of the unit or combined substance of

enzymes, which is presented in pharmaceutical doses and which contribute to prevent and cure

diseases, structure or function of human or animal body; and

(ii) “Biological medicine” mentioned in this means any medicine in which there is an active

substance which has been manufactured or extracted from any biological living system and which

needs physicochemical test including biological test;

(6) “Drug Court” means the Drug Courts mentioned in section 62;

(7) “Drug Control Committee” means the Drug Control Committee constituted under section

12;

(8) “Cosmetics” means toiletries relating to drugs which is claimed to change physical condition

of human body by rubbing, pouring or spraying;

(9) “Committee” means any Committee mentioned in section 12, and it shall also include any

sub-committee;

(10) “company” means any company established and registered under the Companies Act,
 1994 (Act No. XIX of 1994);

(11) “clinical trial” means bioavailability test or bioequivalence test including clinical,

pharmacological, pharmacodynamics and pharmacokinetics test of any new drugs or research-

based new drugs in human body or animal body, the data obtained from which is used to

determine the adverse effect, security, effectiveness and tolerability of such drugs;

Explanation. —

a) “bioavailability test” mentioned in this clause means to determine the rate and quantity of

drugs in human or animal body which exists in blood circulation;

b) “bioequivalence test” mentioned in this clause means to determine variation of the rate

and quantity of absorption of active substances any drug in comparison with the rate and

quantity of absorption of active substances of the standard drugs in the same condition and

management;

(12) “Good Manufacturing Practice (GMP)” means the practice of manufacturing and

quality control of drugs described in the guidelines of the World Health Organization;

(13) “Drug Analyst” means any Drug Analyst appointed in accordance with the provisions

of section 51;

(14) “Schedule” means the Schedule of this Act;

(15) “counterfeit drugs” or “counterfeit drugs” or “counterfeit or falsified or spurious

cosmetics” means any drug or cosmetics of the nature mentioned in sub-section (2) of

section 38;

(16) “registration” means the registration of drugs or cosmetics, as the case may be, under

section 22 or 32;
 (17) “sub-standard” means which not of Standard Quality;

(18) “prescribed” means prescribed by rules or, until rules are made, prescribed by the

Directorate by order in written with the prior approval of the Government;

(19) “new drug” means—

(a) the drug or the active substance of which has not been registered by the

Licensing Authority or has not been recommended by the Drug Control

Committee;

(b) the form of different dimensions and doses of registered drugs;

(c) drugs formed by combination of more than one drugs already registered in

different doses form separately;

(20) “laboratory” means the National Control Laboratory mentioned in section 10 and it shall

also include the Drug laboratory;

(21) “animal” means all mammal animal other than human being, birds, bees, animals of

reptile nature and aquatic animals including fishes and, any other animal declared by the

Government in the official Gazette;

(22) “pharmacovigilance” means the science and activities relating to identification,

observation, evaluation, understanding and prevention of adverse effect of drugs or any

formulation of drugs;

(23) “Pharmacist” means any Pharmacist registered in the register of the Bangladesh Pharmacy

Council in ‘A’ category;

(24) “the Code of Criminal Procedure” means the Code of Criminal Procedure, 1898 (Act No. V
of 1898);

(25) “rules” means rules made under this Act;

(26) “Advertisement” means any notification, leaflet, circular or document that is 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

announcement which is presented orally or by any other means transmitted through light or

sound and this also includes any commercial circulars, compacted inserts and levels;

(27) “person” means any person, and it shall also include any company, association,

partnership business, statutory or any other organization or institution or representatives

thereof;

(28) “Adulterated Drugs” or “Adulterated Cosmetics” means any drug or cosmetics of the kind

mentioned in Sub-section (2) of Section 39;

(29) “vaccine” means any antigenic substance prepared from any diseases-causing organism or

alternative synthetic agent that confers immunity against one or more diseases;

(30) “Director General” means the Director General of the Directorate General of Drug

Administration;

(31) “certificate of marketing authorization” means the certificate of marketing authorization

issued under sub-section (2) of section 22;

(32) “misbranded drugs” or “misbranded cosmetics” means any type of drugs or cosmetics

mentioned in sub-section (3) of section 37;

(33) “medical device” means—

(a) any instrument, apparatus, implement, machine, appliance, implant, diagnostic

 reagent (in vitro, in vivo and in silico reagent), software or similar or relative

material which is used singly or in combination for any one or more of the

following purposes related to treatment of humans or animals, namely: —

(i) for diagnosis, prevention, monitoring of diseases or treatment or palliation;

(ii) for identification, monitoring, mitigation of damage of injury or

compensation thereof;

(iii) for anatomy or physiological process, investigation, transplantation, change

or aid;

(iv) to protect life or vitality;

(v) as birth-control or device sterilization;

(vi) for providing information by examining and analyzing sample collected from

humans’ body or animals’ body, the expected activities of which are not

conducted by pharmacological, immunological or metabolic process; and

(b) any device or diagnostic reagent declared by the Government, from time to

time, for carrying out the purposes of this Act;

(34) “licence” means licence of drugs or cosmetics, as the case may be, mentioned in section

14 or 31;

(35) “licence agreement” means an agreement executed by a domestic or foreign

pharmaceutical manufacturing company with a Bangladeshi pharmaceutical manufacturing

company having licence issued by the Licencing Authority for the purpose of manufacturing

pharmaceutical in Bangladesh;

(36) “Licencing Authority” means the Director General.

3. An act to override other laws. — Notwithstanding anything contained in any other law to the

contrary for the time being in force, the provisions of this Act shall have effect.

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

4. Directorate General of Drug Administration. — For carrying out the purposes of this Act, the

existing Directorate General of Drug Administration shall remain in force as if it had been

established under this Act.

5. Office of the Directorate. — (1) The Head Office of the Directorate shall be located in Dhaka.

(2) The Government may, if it deems necessary, set up branch offices of the Directorate in Division,

District, Upazila or at any other place.

6.Functions of the Directorate. — The following shall be the functions of the Directorate, namely:

(a) in respect of licence of drug manufacturing, selling, importing and exporting of drug

by any establishment and in respect of licence of manufacturing, importing and

exporting of cosmetics by any establishment.

(b) in respect of registration and certificate of marketing authorization of drugs and

 registration of cosmetics;

(c) monitoring and control of drug market;

(d) control of cosmetics production, distribution, quality control, inspection, monitoring

and import and export;

(e) implementation of pharmacovigilence activities;

(f) inspection, monitoring and control of drugs and cosmetics manufacturing and

selling establishments;

(g) approval and inspection of clinical trial;

(h) inspection of drug laboratories including taking necessary actions;

(i) activities relating to vaccine lot release;

(j) taking action for determining and controlling the quality of drugs;

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

(l) taking any legal action to perform the above-mentioned functions.

7.Director General. — (1) There shall be a Director General of the Directorate of Drug

Administration.

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

service shall be determined / fixed by the Government.

(3) The Director General shall be whole-time Officer and Chief Executive of the Directorate.

(4) If a vacancy occurs in the office of the Director General, or the Director General is unable to

discharge the functions of his office on account of absence, illness or any other cause, Additional

Director General of the Directorate or any person appointed by the Government shall act
temporarily as the Director General until a new Director General is appointed

and takes over charge of his office or until the Director General resumes the functions of his office,

as the case may be.

8. Powers and functions of the Director General. — (1) For carrying out the purposes of this Act,

the Director General shall perform all administrative and financial affairs of the Directorate and

subject to the provisions of this Act and rules made thereunder, exercise the powers, perform the

duties and functions assigned to him.

(2) Without prejudice to the provisions of sub-section (1), the Director General shall perform such

duties as may be assigned by the Government from time to time.

9. Delegation of power. — The Director General may, if necessary, delegate any of his powers or

duties under this Act by order in writing, to any employee sub-ordinate to him.

10. National Drug Control Laboratory, Pharmaceutical Laboratory, etc. – (1) For the purpose of

controlling the quality of drugs, there shall be a laboratory in Dhaka under the Directorate, which

shall be known as the [National Drug Control Laboratory (NDCL)].

(2) The Laboratory as referred in sub-section (1), will carry out drugs related testing, analysis,

evaluation, research work including other tasks as time to time allocated by the government and

the Directorate.

(3) Other than the laboratory referred to in sub-section (1), there will be Drug Testing Laboratories

(DTL), as may be required by the Directorate at any place in Bangladesh.

(4) The functions and administration, management and appointment of employees of laboratories

mentioned in sub-section (1) and (3) and matters ancillary thereto shall be prescribed by rules.

11. Appointment of employees. — The Government may, according to the organogram approved
thereby, appoint the necessary number of employees as may be required for the efficient

performance of the Directorate, and the conditions of their services and their ancillary matters,

shall be prescribed by rules.

12. Constitution of Drugs and Cosmetics Control Committee and Sub - committee and

determination of scope, etc. – (1) For carrying out the purposes of this Act, the Government may,

by notification in the Official Gazette, constitute a committee to be called Drugs Control Committee

and such number of other committees and sub-committees as may be necessary and may

determine their terms, functions and matters ancillary thereto.

(2) For carrying out the purposes of this Act, the Government may, by notification in the Official

Gazette, constitute a committee to be called Cosmetics Control Committee and such number of

other committees, sub-committees as may be necessary and may determine their terms, functions

and matters ancillary thereto.

13. National Drugs Advisory Council. — (1) The Government shall constitute a National Drugs

Advisory Council consisting of a Chairman and such other members as it may appoint from time to

time.

(2) The National Drugs Advisory Council shall advise the Government on the following matters,

namely: —

(a) implementation of the national drug policy adopted by the Government;

(b) promotion (development) of local pharmaceutical industries and production and

supply of essential drugs for meeting the needs of the country;

(c) for carrying out the purpose of clause (b), declare (should be noun) some drugs
 as ‘essential drugs’ from amongst Allopathic, Ayurbedic, Unani, Homeopathic,

Biocamic and Herbal and Veterinary drugs and publish (should be noun) list

thereof and update the list in every two years;

(d) import of drugs and it’s raw materials;

(e) co-ordination of the activities of the various Ministries, Government agencies

and persons dealing with manufacture, import, distribution and sale of drugs;

and

(f) any matter which may be considered necessary and expedient in emergency.

(3) The Government shall, by notification in the Official Gazette, determine the constitution,

terms / tennure and functions of the National Drugs Advisory Council.

Chapter III
Licence of drugs, etc.

14. Obtaining licence for manufacture, sale, stock, distribution or exhibition for sale of drugs. —

(1) No person or organization shall manufacture, sell, stock,

distribute any drug or exhibit for sale without obtaining a licencee from the Licensing Authority or

without complying with the conditions specified in the licence:

Provided that nothing in this section shall, subject to the specified conditions, apply to production

of drugs in small quantity for the purpose of research, analysis or medical studies:

Provided further that no new project shall be taken / initiated or existing project shall be extended

without previous approval of the Licensing Authority.

(2) No person or organization / establishment shall use internet or web-based process in selling,
stocking, distributing any drugs or exhibiting for sale of any drugs without a licence issued by the

Licensing Authority or without complying conditions specified in the licence.

(3) No person or organization / establishment shall stock drugs with the intention of making more

profit by creating artificial shortage of drugs for dishonest purposes.

(4) Eligibility for obtaining licence, application for licence or renewal of licence, acceptance and

rejection of application, fees of licence or renewal of licence and conditions of licence and matters

ancillary thereto shall be prescribed by rules:

Provided that the Government may, by notification in the Official Gazette, revise the fee of licence

and renewal of licence and, as the case may be, late fee, from time to time

15. Duration and renewal of licence. — (1) The licence shall be valid for 2 (two) years from the

date of issuance thereof and it shall be renewable.

(2) For renewal of licence, an application shall be made to the Licensing Authority before not less

than 90 (ninety) days of expiry date of the licence in accordance with this Act.

16. Procedure to be followed by the Licensing Authority for issuing and renewal of licence. — (1)

The Licensing Authority shall, for the purpose of issuance or renewal of licence, if necessary, make

inspection of premises of manufacturing and selling company / establishment and, shall issue or, as

the case may be, renew the licence to such premises which will be considered eligible in

accordance with this Act and rules.

(2) The power to grant or reject the application of licence or renewal of licence shall vest in

Licensing Authority.

17. Good practice relating to manufacture and control of quality, distribution, supply and

preservation of drugs. — (1) In manufacturing, controlling of quality, distribution or supply and

preservation of drugs, the manufacturing or selling establishment shall follow the Good Practices

(GxP) guidelines of the World Health Organization.

(2) The Government may prepare guide lines in respect of manufacture, control of quality,

distribution or supply and preservation of drugs following the guidelines made by the World Health

Organization and other recognized international organizations.

18. Cancellation, temporary suspension of licence, etc.— (1) The Licensing Authority may cancel

or, as the case may be, temporarily suspend the licence on any of the following grounds, if the

licensee—

(a) violates or contravenes this Act or the rules or any condition specified in the

licence;

(b) fails to manufacture drugs according to the Good Manufacturing Practice (GMP);

(c) obtains licence by providing any false information or by concealing information;

(d) uses the licence for any purposes of other than establishing or operating a

factory or establishment for the purpose manufacturing and processing drugs;

(e) alters the physical infrastructure of the premises of the concerned

establishment, without obtaining the prior approval of the Licensing Authority,

in such manner that adversely affects or likely to affect the quality of drugs; or

(f) fails to comply with any other prescribed condition.

(2) Before cancelling or temporarily suspending a licence under sub-section (1), the Licensing

Authority shall issue a notice to the concerned licensee specifying the appropriate reason and

time-limit to submit written statement, if any.

(3) On receiving the written statement of the notice issued under sub-section (2), if the written
statement is not satisfactory, the Licensing Authority may, after recording the reasons, cancel the

licence or temporarily suspend the licence for such period as it thinks fit and may immediately stop

the manufacturing of drugs by such establishment.

(4) If the written statement referred to in sub-section (2) is satisfactory, the Licensing Authority

shall discharge the licensee from the charges brought against him.

19. Revision / Review or appeal against order of temporary suspension of licence and stoppage

of manufacturing. — (1) If the licence of the licensee is suspended temporarily and the

manufacturing of drugs by the concerned establishment is stopped under section 18, the licensee

may, within a period not exceeding 30 (thirty) working days, apply to the Licensing Authority for

revision / review of such order or may file an appeal to the Government.

(2) In disposing the revision / review or appeal referred to in sub-section (1), the concerned

Authority shall give its decision after giving the parties concerned an opportunity of being heard.

(3) In disposing the revision / review or appeal, the decision of the Licensing Authority or the

Government, as the case may be, shall be final.

20. Manufacturing of drugs under licensing agreement, etc.— (1) The Licensing Authority may,

after specifying such conditions as may be necessary for the protection of public interest, permit

any foreign establishment to manufacture any drugs within Bangladesh under licensing agreement

with any manufacturing establishment in Bangladesh:

Provided that before giving such permission, the Licensing Authority shall be ensured that any drug

which is the research product of such company / establishment, is registered under the same

brand name in any of the countries specified under sub-section (3) of section 41.

(2) Any drug manufacturing establishment in Bangladesh may be allowed to manufacture any drug
under any written agreement with any similar drug manufacturing establishment.

(3) Any foreign company / establishment having no drug manufacturing factory in Bangladesh may

manufacture all approved methods of drugs under contract manufacturing or loan licence with its

respective methods only for the purpose of export:

Provided that such manufactured drugs however shall not be marketed in local market by any

means.

(4) The licensing authority may, in granting approval under this section, impose such conditions as

it thinks fit for the purpose of protecting public health.

(5) The Licensing Authority may, notwithstanding anything contained in this section, withdraw the

approval granted to a foreign drugs manufacturer in respect of the manufacture of any drug if it is

considered necessary to avoid any adverse effect on public health.

Explanation. —In this section—

(a) “Loan Licence” means a licence issued by the Licensing Authority to any person or company /

establishment which does not have its own management or facilities of manufacturing drugs, but

intends to take management or facilities belong to any other licensee for manufacturing drugs; and

(b) “Contract Manufacturing” means a contract executed by a drug manufacturing company /

establishment in Bangladesh with a foreign company / establishment having no drug

manufacturing factory in Bangladesh for manufacturing approved methods of drugs with its similar

drug establishment for export purposes only.

21. Amendment to licence agreement executed with a foreign establishment. — (1) If a licence

agreement executed by a foreign establishment with a Bangladeshi establishment for

manufacturing drugs within Bangladesh contains any provision against the national interest, the

Licensing Authority may direct the said establishment to amend the relevant provisions in the

agreement.

(2) If the concerned company / establishment fails to comply with direction issued under sub-

section (1), the Licensing Authority may cancel the licence granted in favour of such company /

establishment for manufacturing drugs.

Chapter 4
Drug Registration, Marketing Authorization Certificate, etc.

22. Drug registration and marketing authorization certificate, etc. — (1) No person or

establishment shall manufacture, import, export, sell, distribute, stock or exhibit any drug without

obtaining licence from the Licensing Authority.

(2) Notwithstanding anything contained in sub-section (1), marketing authorization certificate shall

be obtained from the Licensing Authority before distribution, marketing and sale of registered

drugs.

(3) The Licensing Authority shall not register any drug without the recommendation of the Drug

Control Committee.

(4) Notwithstanding anything contained in sub-section (3), registration certificate of drugs may be

issued without prior recommendation of the Drug Control Committee, on imposing specified
conditions, for public health and national emergency to meet sudden catastrophe, spread of

epidemic or disaster.

Provided, however, that, after such registration, within a maximum of 90 (ninety) days, it shall be

submitted for recommendation to the Drugs Control Committee.

(5) The eligibility of obtaining registration, application of registration and renewal of registration,

grant and rejection of application and conditions of registration and other matters ancillary thereto

shall be prescribed by rules.

(6) Notwithstanding anything contained in sub-section (5), the Licensing Authority may, in respect

of registration of drugs, impose such conditions as it may consider fit in public interest.

(7) The establishment making application for the registration and marketing authorization

certificate of any drug shall submit satisfactory information in respect of quality, safety and efficacy

of the concerned drug as may be required by the Licensing Authority.

(8) No person or establishment shall sell or distribute any drug unless the brand or generic name of

such drug is approved by the Licensing Authority.

(9) If a drug under any brand name is sold by more than one company, the ownership of such

brand name shall be vested in the company which first obtained the registration.

(10) In case of registration of a particular drug, the information in respect of clinical trial or

bioequivalence study shall be submitted as may be required by the Licensing Authority.

(11) The manufacturing establishment shall follow special identification procedures to prevent

counterfeiting of certain drugs as may be required by the Licensing Authority.

(12) If the Government, for the purpose of registration of homeopathic and biochemic drugs, by

notification in the Official Gazette, prescribes the pharmacopeia of any such country, in which
particular standards have been adopted in the guidelines for preparation and use of homeopathic

and biochemic drugs, then the Licensing Authority shall follow those standards.

(13) For the purpose of registration of Unani, Ayurbedic and Herbal drugs, the Licensing Authority

shall follow the standards as may be prescribed by the Government

23. Term of registration and marketing authorization certificate. — (1) The registration of drugs

shall remain valid and effective for a period 5 (five) years.

(2) The registration shall be renewable and application for renewal of the registration shall be

made not later than 90 (ninety) days before the expiry of term, in accordance with the provisions

of this Act.

(3) The power of granting or rejecting the application for renewal of registration shall vest in the

Licensing Authority.

(4) The marketing authorization certificate shall remain valid and effective for as long as the

registration is valid and effective.

24. Fees for registration and renewal of registration, etc.— (1) The fees for registration and

renewal of registration and, as the case may be, late fees, shall be prescribed by rules:

Provided, however, that the Government may, by notification in the Official Gazette, revise such

fees from time to time.

(2) The Licensing Authority shall not register or, as the case may be, renew the registration of any

drugs unless the prescribed fee is paid in accordance with sub-section (1).

25. Cancellation or temporary suspension of registration. — (1) The Licensing Authority may, on

the recommendation of the Drugs Control Committee, cancel the registration of any drug.
(2) Notwithstanding anything contained in sub-section (1), if the Licensing Authority is satisfied

that any drug is sub-standard, spurious, adulterated, misbranded or the required facilities for

manufacturing is below the standard quality, it may cancel or temporarily suspend the registration

or stop the manufacturing and suspend the marketing of such drug.

(3) The Licensing Authority shall, before cancelling or temporarily suspending the registration of

any drugs, mentioning the proper reason and time-limit thereof, issue a notice to the concern

person or establishment to submit written statement, if any.

(4) On receiving the written statement of the notice issued under sub-section (3), if the written

statement is not satisfactory, the Licensing Authority may, recording the reasons, cancel the

registration of concerned drug or temporarily suspend the registration thereof for such period as it

thinks fit.

(5) If the written statement referred to in sub-section (3) is satisfactory, the Licensing Authority

shall exempt the concerned person or establishment from the allegations brought against it and

withdraw the order regarding stopping of manufacture and suspension of marketing of drugs.

26. Withdrawal from market, destruction, stopping of sale or suspension of marketing, etc.— (1)

In case of cancellation or temporarily suspension of sub-standard

drugs or registration of drugs, the Licensing Authority may, issue such order as may be necessary

to destroy the drugs, after withdrawing from market, the manufacture of which has been

suspended.

(2) If the use of the registered drugs results in adverse reactions in humans or animals, or if any
human or animal dies as part of the reaction, the Licensing Authority may, with immediate effect,

issue an order to stop the sale and suspend the marketing of drug concerned, until further

direction is given.

(3) After issuing an order under sub-section (2), on/upon the confirmation of the adverse reaction

through the test and analysis report of the concerned laboratory or by any other means or

method, if the Licensing Authority issues an order to withdraw and destroy the drug from the

market, the concerned establishment shall destroy the drug and notify the Licensing Authority.

27. Review or appeal against the order of temporary suspension of registration and suspension

of manufacturing and marketing of drugs. — (1) If the registration of any drug is temporarily

suspended and the manufacturing and marketing of such drug is suspended by the Licensing

Authority under section 25, the concerned person or establishment may, within a period not

exceeding 30 (thirty) working days, apply to the Licensing Authority for review of such order or

may prefer an appeal to the Government.

(2) In disposing of the review or appeal referred to in sub-section (1), the concerned Authority shall

give its decision after giving the parties concerned an opportunity of being heard.

(3) In disposing of the review or appeal, the decision of the Licensing Authority or the Government,

as the case may be, shall be final.

28. Duties and functions of the Drugs Control Committee in case of registration of drugs and

cancellation or temporary suspension of registration. — (1) For carrying out the purposes of this

chapter, the following shall be the duties and functions of the Drugs Control committee, namely: —

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

(b) in recommending cancellation or temporary suspension of registration of drugs, evaluation

of registered or registerable drugs and evaluation to determine the safety, efficacy and

utility of drugs that may be manufactured or imported.

(2) On the evaluation under sub-section (1), if it appears to the Drug Control Committee that the

concerned drug is safe, usable or effective, it shall recommend the Licensing Authority to register

concerned drug and if it appears that such drug is not safe, usable or effective, it shall recommend

the Licensing Authority to cancel or temporarily suspend the registration of such drug.

29. Publication of the list of registered drugs. — The Directorate General shall publish the list of

registered drugs with specified information and, update such list from time to time.

30. Fixation of price of drugs and raw materials of drugs. — (1) The Government may, by

notification in the Official Gazette, fix the maximum retail price of drugs enlisted under sub-section

(2) and imported.

(2) For carrying out the purpose of sub-section (1), the Government shall prepare a list of drugs the

maximum retail price of which shall be fixed and publish the same by notification in the Official

Gazette.

(3) The Government may, by notification in the Official Gazette, fix the maximum retail price of raw

materials of any local drugs to be used in manufacturing of drugs.

(4) No person or establishment shall sell any drugs or raw materials of manufacturing of drugs at a

price higher than the maximum price as fixed.

 CHAPTER V
Cosmetics, etc.

31. Licence of cosmetics. — (1) No person or company shall manufacture, distribute, import or

export cosmetics without obtaining a licence from the Licensing Authority or without complying

with the conditions specified in the licence.

(2) The eligibility for obtaining licence, application for licence and renewal of licence, grant or

rejection of application, fees of licence and renewal of licence and conditions of licence and other

matters relating thereto shall be prescribed by rules:

Provided, however, that, until rules are made, the Directorate may by order, subject to the prior

approval of the Government, make necessary provision in respect of the said matters:

Provided further that the Government may, by notification in the Official Gazette, from time to

time, revise the fees of license and renewal of license and, as the case may be, late fees.

32. Registration of cosmetics. — (1) No person or establishment shall manufacture, distribute,

import or export any types of cosmetics without obtaining registration from the Licensing

Authority.

(2) The eligibility for obtaining registration, application for registration and renewal of registration,

grant or rejection of application, fees of registration and renewal of registration and conditions of

registration and other matters relating thereto shall be prescribed by rules: Provided, however,

that, until rules are made, the Directorate may by order, subject to the prior approval of the

Government, make necessary provisions in respect of the said matters:

Provided further that the Government may, by notification in the Official Gazette, from time to
time, revise the fees of registration and renewal of registration and, as the case may be, late fees.

33. Special provisions relating to manufacture, distribution, import and export of existing

cosmetics, etc.— (1) The existing factories or business establishment engaged in manufacturing,

distribution, import and export cosmetics shall, within a period not more than 6 (six) months of the

making of rules or, as the case may be, issuance of order under this Act in respect of concern

matter, apply to the Licensing Authority for licence and registration as the case may be.

(2) After receiving the application under sub-section (1), the Licensing Authority shall, subject to

the provisions of section 31 or section 32, as the case may be, dispose such application.

34. Application and applicability of section 48.— For carrying out purposes of this Chapter, the

provisions of Chapter IX relating to powers of Inspector shall, so far as applicable, apply to the

enforcement and execution of the provisions of sections 31, 32 and 33.

35. Determination, control, application, etc. of the quality of cosmetics. — (1) For the carrying

out the purposes of this Act, the Government shall prescribe by rules the determination and

control of quality of cosmetics, laboratories, analysts and his report, advertisement and

identification of misbranding, imitation, adulteration and spurious and relating thereto:

Provided, however, that in determining the quality of cosmetics the Government may follow the

existing Bangladesh standard relating thereto and the standard prescribed by international

organization and other countries including EU, USFDA and ASEAN.

(2) No person other than a physician registered by the Bangladesh Medical and Dental Council

(BMDC) or under the supervision of such physician shall apply filler, botox, glutathione or any
similar cosmetics to the human body by injection or otherwise.

(3) The Government may, by rules, make necessary provisions regarding the application and use of

cosmetics by beauty parlors to prevent misuse and abuse of cosmetics in beauty parlors.

Chapter Six
Standard quality of drugs and misbranded, counterfeit, and adulterated drugs
or cosmetics, etc.

36. Standard quality of drugs. — (1) No person or company shall manufacture, sell, stock,

distribute, exhibit for sale or import any drugs which are not of standard quality.

(2) No person, whether as owner/proprietor or agent, shall knowingly give to the purchaser a

warranty regarding any drug which is of below the standard quality that the consumption or use of

such drug does not affect adversely and does not contravene the provisions of this Act.

(3) For the purpose of this section standard quality means—

(a) in case of any drug including the Unani, Ayurvedic, Homoeopathic and Biochemic or Herbal

drugs, the standard prescribed by the Government;

(b) in case of other drugs, standard described in the last 5 (five) editions of the official compendia

or, in the absence of a specific monograph of any drug in official compendia, the general guidelines

as stated in the official compendia or specifications laid down by the inventing company for

determination of standard. Explanation: “Official Compendia” mentioned in this section means

British Pharmacopeia, United States Pharmacopeia, United States National Formulary, European

Pharmacopeia or any recognized international pharmacopeia.

37. Misbranded Drugs or misbranded cosmetics. — (1) No person or establishment shall

manufacture, sell, stock, distribute or exhibit for sale any misbranded drugs or misbranded
cosmetics.

(2) The Licensing Authority shall preserve the brand name of drugs and cosmetics and shall not

permit any brand name of misbranded drugs or misbranded cosmetics.

(3) For the purposes of this section any drugs or cosmetics shall be deemed to be misbranded if—

(a) it is so coloured, coated, powdered or polished that damage of it is concealed, or if it is

made to appear of better or greater quality than it really is;

(b) it is not labelled in the prescribed manner;

(c) its label or container or anything accompanying the drug bears any statement, design or

device which makes any false claim for the drug or cosmetics, or which is false or

misleading in any particular; and

(d) its brand name resembles any existing brand name or sounds same or appears same in a

manner likely to deceive the user of such drugs or cosmetics.

38. Counterfeit drugs or counterfeit cosmetics. — (1) No person or establishment shall

manufacture any counterfeit drugs or cosmetics or knowingly sell, stock, distribute or exhibit for

sale any counterfeit drugs or counterfeit cosmetics.

(2) For the purpose of this section drugs or cosmetics shall be deemed to be counterfeit or falsified

or spurious if—

(a) it is imitated by using the bottle, strip, foil, label, monogram, logo, etc. of a

popular drug or cosmetic for dishonest purpose in such a manner that outwardly

the said drug or cosmetic appears to be the original drug or cosmetic;

(b) it substitutes for, or resembles any other drug or cosmetics in a manner likely to
 deceive people;

(c) it claims or purports to be the drugs or cosmetics of a place or country of where

it is not truly manufactured;

(d) it is imported under a name which actually belongs to another drugs or

cosmetics; or

(e) the name of any person, institution or company is expressed on its label or

container in such manner as to make the public believe that the person,

institution or company is the producer or manufacturer of the drug or

cosmetics, but in fact the person, institution or company does not exist or is

fake.

39. Adulterated drugs or adulterated cosmetics. — (1) No person or establishment shall

adulterate any drugs or cosmetics or manufacture, sell, stock, distribute or exhibit for sale any

adulterated drugs or adulterated cosmetics.

(2) For the purpose of this section, any drugs or cosmetics shall be deemed to be adulterated,

knowing that it will be used or sold or it may be sold or used, willfully or dishonestly for the

purpose of obtaining unfair profit or for sabotage or any other malicious purpose, any substance,

material or ingredient is mixed with it or any essential substance, material or ingredient is removed

in such manner that it reduces the efficacy or alters the effectiveness of such drugs or cosmetics or

otherwise causes harm to it resulting in bodily harm or endangering life.

40. Prohibition to sell certain drugs. —No person or company shall sell or, as the case may be,

stock or exhibit for sale the following drugs, namely: —

(a) Government drugs;

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

(c) physician sample types drugs; or

(d) antibiotic or any other drug without the prescription of a registered physician

other than Over the Counter drugs.

Chapter-7
Restrictions on the import and export of Drugs
41. Prohibition on import of drugs. — (1) No drug shall be imported without license or beyond the

conditions imposed under the licence.

(2) No registered drug shall be imported without the prior approval of the Licensing Authority.

(3) The Licensing Authority shall not, for the purpose of import, grant registration or licence of any

drug for human or animal use, unless such drug has been registered under the same brand name in

such countries as the list of such countries are, from time to time, published by the Government.

(4) Nothing in this section shall apply in case of import, subject to prescribed conditions, of small

quantities of any drug for the purpose of examination, test, analysis, research or personal use and
in case of import any drug to meet the national crisis.

(5) In case of registration of importable drugs, the Directorate may inspect the manufacturing

premises of manufacturing establishment, if necessary, for verification of the Good Manufacturing

Practice (GMP).

(6) All expenses in respect to inspection specified in sub-section (5) shall be paid by the

manufacturing establishment at such rate as may be prescribed by the Government, from time to

time, by rules or order.

42. Prohibition on procurement and import of raw materials of drugs, and packaging materials of

drugs, etc— (1) No manufacturing of raw materials of registered drugs or packaging material of

drugs shall be collected locally or imported without the prior approval of the Licensing Authority.

(2) No Semi Finished drugs or any other ingredient or material necessary for the manufacture of

drug shall be imported without the prior approval of the Licensing Authority.

(3) In case of registration of importable raw materials for the manufacture of drugs or packaging

materials of drugs, the Directorate may inspect the manufacturing premises of manufacturing

establishment, if necessary, for verification of the Good Manufacturing Practice (GMP).

(4) All expenses in respect to inspection specified in sub-section (5) shall be paid by the

manufacturing establishment at such rate as may be prescribed by the Government, from time to

time, by rules or order.

43. Prohibition on export of drugs without license — (1) No drug can be exported without

obtaining a license from the Licensing Authority.

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

(3) Notwithstanding anything to the contrary contained in this section, subject to permission of

Licensing Authority, the provisions of sub-section (1) and (2) will not apply in case of export or

sending outside the country of small quantities of any drug for the purpose of research, analysis or

personal use.

Chapter VII
Supervision of qualified persons including pharmacists in the manufacture of drugs

44. Presence and supervision of qualified person in manufacturing of drugs, etc. — (1) No person

shall manufacture any allopathic drug except under the direct supervision of two academically

qualified personnel specified in clause (a) and (b), namely: —

(a) a pharmacist; and

 (b) a person having Bachelor degree with honours or Master’s degree in Chemistry,

Biochemistry, applied chemistry, Microbiology, Pharmacology, Pharmacy,

Medicine, Genetic Engineering or Chemical Engineering from any university or

institute recognised by the Government.

(2) No person shall manufacture any Unani, Ayurvedic, Homeopathic or Biochemic and other

herbal drug without the direct supervision of two institutionally qualified personnel specified in

clause (a) and (b), namely: —

(a) a person having Bachelor degree in the respective field from any university or

institution recognised by the Government or, a person having diploma degree in

the respective field with at least 01 (one) year’s practical experience in the

manufacture and quality control of respective drugs ; and

(b) a person having Bachelor degree with honours or post-graduation degree in

pharmacy, Chemistry, Botany, Biochemistry, Applied Chemistry or Microbiology

from any University or institute recognised by the Government.

45. Supervision of qualified persons in the sale of drugs, etc.— (1) No person, being a retailer,

shall sell any Allopathic drug without the personal supervision of pharmacist, diploma pharmacist

or pharmacy technician.

(2) No person, being a retailer, shall sell any Unani, Ayurvedic or Herbal system of drugs without

the personal supervision of registered unani doctor, ayurvedic doctor, pharmacist, diploma

pharmacist or pharmacy technician.

(3) No person shall sell any homeopathic or biochemic system of drugs without the personal
supervision of registered homeopathic doctor.

(4) Notwithstanding anything contained in sub-section (1), (2) and (3), supervision of pharmacist,

diploma pharmacist, pharmacy technician, registered unani doctor, ayurvedic doctor or

homeopathic doctor shall not be required in the wholesale sale of drugs.

Explanation —mentioned in this clause:

(a) “Diploma Pharmacist” means a „B‟ category Diploma Pharmacist who is

registered with the Register of Bangladesh Pharmacy Council; and

(b) “Pharmacy Technician” means a „C‟ category Pharmacy Technician registered

with the Register of Bangladesh Pharmacy Council.

46. Information about qualified persons. — Updated information of qualified persons including

pharmacist, diploma pharmacist and pharmacy technician, as the case may be, shall be submitted

to the Licensing Authority compulsorily by the concerned person or organization.

Chapter IX

Appointment of inspectors, power, etc.

47. Inspectors. — (1) The Government may, by notification in the Official Gazette, appoint such
number of persons as it thinks fit, having the prescribed qualifications, to be Inspectors for the

purposes of this act:

Provided, however, that no person who has any financial interest in the manufacture, import,

export, sale or marketing of drugs and cosmetics shall be appointed to be an inspector.

(2) Every Inspector shall be deemed to be a public servant within the meaning of section 21 of

Penal Code (Act XLV of 1860

48. Powers of Inspectors. — (1) For carrying out the purposes of section 47, in prescribed manner

every Inspector, within the local limits prescribed by the Licensing Authority , and any other area

on local limits with the permission of the licensing authority, —

(a) may inspect and verify the place of manufacture, manufacturing plant and

production capacity, manufacturing process, standardization of prescribed

quality and equipment used for testing and analysis and related records and

registers of any drugs and cosmetics;

(b) may inspect imported raw materials or packaging materials for the manufacture

of drugs and cosmetics and storage of imported drugs and cosmetics and all

records and registers relating thereto;

(c) may inspect any place of sale of drugs and cosmetics or place of storage, display

or distribution for the purpose of sale and storage arrangements and related

records and registers;

(d) may take samples of any drugs and cosmetics which are being manufactured,

sold or stocked or exhibited for sale or are being distributed;

(e) may enter and search the concerned buildings, places or vehicles at reasonable
 times he himself or, by taking such assistance from proper authorities or law

enforcement agencies as he considers necessary, where it appears that an

offence under this act or rules has been or is being or is likely to be committed in

any buildings or places or any vehicles by land, water, air and seize or detain

such drugs, cosmetics and other related materials;

(f) may call any person from the neighborhood to be present on the spot as witness

in course of search or seizure under this act or rule and during the investigation

of the offence committed under this act or rule;

(g) may require any person to appear before him at any reasonable time at any

proper place to give statement, assistance or information relating to an offence

committed under this act or rules: Provided that the exemptions under

sections 132 and 133 of the Code of Civil Procedure, 1908 (Act No V of 1908)

shall be applicable to requisitions for attendance under this clause;

(h) may lock or seal that place or places of In any factory, laboratory, shop,

pharmacy, building, warehouse or godown, where drugs and cosmetics are

manufactured, sold, stocked or displayed or distributed for sale without

obtaining the necessary license under this Act or where under this Act or rules, if

it appears that a crime has been committed, is being committed or is likely to be

committed.

(i) may forbid for a reasonable period not exceeding 3 (three) months the person in

charge of that premises from removing his drug, cosmetics or other things

connected therewith or any drug, cosmetics or materials which may be used in

 evidence of the commission of an offence under this act or rules; and

(j) may exercise all or any such powers as may be relevant for carrying out the

purposes of this act or rules.

(2) No person or body shall obstruct the inspector in the exercise of his powers under sub section

(1).

(3) The provisions of the Code of Criminal Procedure, 1898, in so far as they are not inconsistent

with the provisions of this Act, shall apply to searches, seizures and detention made under this Act.

49. Disclosure of premises for manufacture, storage, sale, distribution, etc. of drugs and

cosmetics. —Every person for the time being in charge of the premises of manufacture, storage,

sale, and distribution of drugs and cosmetics, on being required by an Inspector so to do for the

period concerned, shall be legally bound to disclose the premises to the inspectors.

50. Procedure followed by inspector. — (1) If an inspector seizes any drug, cosmetics or other

article under this Chapter, he shall give a copy of the same in a prescribed form to the person from

whom such drugs, cosmetics or other articles are to be seized.

(2) If an inspector takes a sample of drugs or cosmetics from any pharmacy, shop or establishment

for the purpose of test or analysis, he shall intimate such purpose in the prescribed form and

manner to the person of the concerned pharmacy, shop or establishment from whom he takes it

and in the presence of such person shall divide the sample into four portions and the Inspector

himself shall give his signature and seal to each part and the signature and identification of the
person providing the sample:

Provided, however, that if the person providing the sample is absent or absconding at the time of

collection of the sample or refuses to sign the sample and form despite being present, the

Inspector shall confirm and seal the matter giving signature by himself in the presence of two

witness:

Provided further that if any establishment is closed or sealed at the time of sample collection, the

Inspector may open the establishment and collect samples in the manner provided by this sub-

section after taking the assistance from, the officer in- charge of the concerned nearest police

station or the Department or Authority concerned:

Provided further that the Inspector may, if necessary, before taking the full sample mentioned in

this sub-section, take a small portion of the sample mentioned, for the purpose of preliminary

examination and test and analyze it by an approved scientific method.

(3) If a sample of any drug or cosmetics is collected from a manufacturing establishment or depot,

it shall be necessary to divide the sample into three portions only and in that case, it shall be

delivered to the person or establishment mentioned in clauses (a), (b) and (d) of sub-section (5).

(4) Where an Inspector fails to collect samples of drugs or cosmetics in sufficient quantity and it is

absolutely necessary to collect samples of the drugs or cosmetics concerned, he shall, without the

division mentioned in sub-sections (2) and (3), subject to the permission of the Director-General,

collect as many samples as possible and mark and, if he thinks necessary, seal the same.

(5) The Inspector shall, after collecting and dividing samples of drugs or cosmetics under sub-

section (2), deliver the portions thereof to the following persons or body for the purposes or

reasons specified below, namely—

 (a) First portion: to the person giving the sample from whom the sample for the

purpose of preservation;

(b) Second portion: to the drug analyst or, as the case may be, analyst for the

purpose of test and analysis;

(c) Third portion: for the purpose of sending to the manufacturer, importer,

marketer or warrantor, if any;

(d) Fourth portion: for the purpose of presentation in the trial court.

Explanation: For carrying out the purposes of this Chapter, ‘Other materials’ shall include

equipment used in production including registers, receipts, invoices and bills, which may be

considered as evidence of the commission of an offence.

Chapter X
Drug analyst, etc.

51. Drug Analyst. —The Government may, by notification in the Official Gazette, appoints such

number of persons as it thinks fit, having the prescribed qualifications, to be Drug Analysts for such

areas or jurisdiction as may be specified in the notification for the test and analysis of any class of
drugs.

52. Reports of Drug Analysts. — (1) If the sample of any drug is sent to the drug analyst for test

and analysis under clause (b) of sub-section (5) of section 50, he shall deliver to the concerned

Inspector a signed report in triplicate in the prescribed form.

(2) On receipt of the report referred to in sub-section (1), the Inspector shall retain one copy of the

report in proper place for use in any prosecution in respect of the sample and deliver the

remaining copies to the person from whom the sample was taken and to the manufacturer,

importer, marketer or warrantor, if any

(3) If any person applies to the trial court with evidence against the report of the drug analyst, the

court may, if necessary, send the preserved sample to the inspector under sub-section (2) for

retest and analysis and the Drug Analyst shall retest and analyse such sample by the National

Control Laboratory and submit the report to the court.

(4) The report received under sub-section (3) shall be deemed to be conclusive evidence before the

court.

(5) The cost of test and analysis by the National Control Laboratory under sub- section (3) shall,

as directed by the court, be paid by the accused person.

(6) No person or establishment shall use the report received under sub-section (1) as

advertisement.

53. Right to obtain report of test and analysis of drug. —Any person shall, on payment of the

prescribed fee, in the prescribed form, apply to the Licensing Authority or through the Inspector,

for the test and analysis of any drug purchased or imported, exportable or manufactured by him,
be entitled to receive the report of such test and analysis signed by the Drug Analyst on the basis

of the said application.

Chapter XI
Offence, penalty, investigation and trial

54. Penalty for contravening the provisions of this act. — If any person does any of the acts

specified in column (3) in accordance with the section mentioned in column (2) of the schedule,

such act shall be deemed to be an offence under this Act and for such offence he shall be

punishable with any or both penalties as mentioned in column 4.

55. Confiscation. —Where any person has been convicted by a competent court for contravening

any provision of this Act or rule, the drugs or cosmetics in respect of which this Act or the rules

have been contravened, the factory of such drugs or cosmetics, godown, machineries, goods,

equipments or such drugs or cosmetics or the materials and ingredients of manufacturing such

drugs or cosmetics may be confiscated by the court.

56. Penalty for committing offence repeatedly. —If a person convicted of an offence under this

Act commits the same offence again, he shall be punishable with twice of the maximum penalty

prescribed in this Act for the offence concerned.

57. Committing of offence by company. — (1) If any offence under this act is committed by any
company, the owner, director, executive officer, manager, secretary, partner or any other officer or

employee of such company who is directly connected with such offence, shall be deemed to have

committed the offence, unless he can prove that such crime was committed without his knowledge

and that he has tried his best to prevent it.

(2) In case of committing any offence under this Act by a company, if it proved that such offence

was committed with consent or with the connivance of any owner, director, manager, secretary,

partner or any other officer or employee of such company or because of their negligence, such

owner, director, manager, secretary, partner or related officer or employee shall be deemed to be

responsible and accordingly he shall be punishable according to the provisions of the concerned

section.

58. Investigation and Investigating officer. — (1) Without prejudice to the generality of section 61,

an employee or Inspector authorised by the Director General within the prescribed manner and

time limit, may investigate any complaint mentioned in column (3) of the schedule as an

investigating officer.

(2) During 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

the assistance of any other agency or authority including the law enforcement agency and if such

assistance is sought, the law enforcement agency and such agency or such authority shall be bound

to render the assistance required.

59. Cognizability and bailability of offences. —Notwithstanding anything contained in the Code of

Criminal Procedure—

(a) mentioned in column (1) of schedule in contrast to serial no. 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, the offences

mentioned in column (3) shall be non-cognizable and bailable in accordance with

sections mentioned in column (2); and

(b) in contrast to serial no. 1, 4, 5, 11, 13, 15, 17, 19 and 23 mentioned in column (1)

of the schedule, the offences mentioned in column (3) shall be cognizable and

non-bailable in accordance with sections mentioned in column (2).

60. Cognizance of offences. -Notwithstanding anything contained in the Code of Criminal

Procedure, no court mentioned in sub-section (2) of section 61 shall take cognizance of an offence

punishable under this Act except on the written report of the Director General or any officer

authorized by him for that purpose.

61. Investigation, trial, etc. of offences— (1) The Code of Criminal Procedure shall apply to the

investigation, trial and arrest or detention of the accused person and other related matters of the

offense committed under this Act.

(2) Notwithstanding anything to the contrary contained in the Code of Criminal Procedure, in

column (1) of the Schedule as mentioned---

 (a) Serial No. 1, 4, 5, 11, 13, 15, 17,19 and 23 against provisions referred in Column

(2) offenses mentioned in column (3) shall be tried by the Drugs Court; And

(b) Serial No. 2, 3, 6, 7, 8,9, 10, 12, 14, 16, 18, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29,

30, 31, 32, and 33 against provisions referred in Column (2) offenses mentioned

in column (3) shall be tried by the Chief Judicial Magistrate or Special Magistrate

or, as the case may be, by the Chief Metropolitan Magistrate or Special

Metropolitan Magistrate.

62. Drug Courts. — (1) For carrying out the purposes of this Act, there shall be one court at every

district headquarters called Drug Court for the trial of the offences mentioned in clause (a) of sub-

section (2) of section 61.

(2) Notwithstanding anything contained in sub-section (1), the Government may, if necessary,

constitute more than one Drug Court in any district and determine territorial jurisdiction.

(3) The Drug Court shall be constituted consisting of one judge and the Government shall, in

consultation with the Supreme Court, appoint the judge of such Court from amongst the District

and Sessions Judges.

(4) Notwithstanding anything contained in sub-section (3), the Government may, if necessary,

appoint any District and Sessions Judge as the Judge of Drug Court in addition to his duties.

Explanation. —In this section District and Session judge shall include Additional District and Session

Judge.

63. Application of the Mobile Courts Act, 2009. —Notwithstanding anything contained in any
other law for the time being in force, in respect of an offence committed under this Act, subject to

being scheduled to the Mobile Courts Act, 2009 (Act No. 59 of 2009), the Mobile Courts may

impose penalties.

64. Appeal. — (1) A person aggrieved by an order, judgment or sentence imposed by the Drug

Court or Chief Judicial Magistrate or Special Magistrate or, as the case may be, the Chief

Metropolitan Magistrate or a Special Metropolitan Magistrate, may file an appeal to the Court

prescribed in the Code of Criminal Procedure against such order, judgement or sentence imposed

within 30 (thirty) days of the concerned order, judgement or sentence.

(2) In case of appeal against the sentence imposed by the Mobile Court, section 13 of the Mobile

Court Act, 2009 shall be followed.

Chapter XII
Clinical trial of drugs, pharmacovigilence, lot release of vaccine, etc.

65. pre-clinical trials, clinical trials, field trials, performance trials, bio-compatibility and bio-

equivalence studies of drugs, vaccines and medical devices. — (1) Subject to approval from the

Licensing Authority, contract research organizations may be conducted for the purpose of pre-

clinical trials, clinical trials, field trials or, performance trials and biocompatibility or bioequivalence
studies of the drugs, vaccine and medical devices.

(2) Notwithstanding anything contained in sub-section (1), the contract research organization

shall not, without obtaining protocol approval from the Licensing Authority, carry out any pre-

clinical, clinical, field trial or performance trial and bio compatibility study or bio equivalence study

on any type of medical product including drugs, vaccines and medical devices used in treatment for

human or animal.

(3) If any activity is conducted by the contract research organization without the approval and

protocol approval from the Licensing Authority as specified under sub-sections (1) and (2), the

Licensing authority may stop such activity and impose such administrative fine as prescribed.

(4) In carrying out the activities mentioned in sub-section (1) Good Clinical Practice (GCP)

guidelines approved by the Government or instructions published by the World Health

Organization or recognized organization of international standards 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 studies or bio-equivalence studies mentioned in sub-

section (2).

(6) Institutional Ethics Committee (IEC), International Review Board (IRB) or Animal Ethics

Committee (AEC) shall be formed by the contract research organization to ensure the safety and

protection of the rights of the participants in the clinical trial, subject to the approval of the

Licensing Authority.

(7) If any risk to the participants appears during the clinical trial, the Licensing Authority may stop

the concerned activities temporarily or permanently.

(8) An approval from the Directorate shall be obtained for the import of investigational medical
products and for sending abroad for the purpose of test and analysis of any samples collected from

trial participants.

(9) The Directorate may accept information from foreign drug regulatory authorities concerning

information received from clinical trial or approved data.

(10) In the case of new drugs for emergency health care or epidemic diseases, the Directorate may,

subject to the approval of the Government, approve fast track clinical trial.

Explanation. — “Contract Research organization”, as referred to in this section, means any such

institution or body which undertakes responsibilities or conducts activities of pre-clinical trial,

clinical trial, field trial or performance trial and bio compatibility or bio equivalence studies under a

contract executed with any person or body as per its requirements.

66. Pharmacovigilance. —(1) For the monitoring of side effects or adverse reactions of drugs in

humans or animal body, drug manufacturers, importers and marketing establishment, hospitals,

clinics, institutions related to public health programs and other organizations related thereto and

stakeholders must send the reports concerning conducting Pharmacovigilance activities and data

related thereto to the Licensing Authority.

(2) In carrying out the activities mentioned in sub-section (1) National Pharmacovigilance Guideline

or Good Vigilance Practice approved by the Government or instructions published by the World

Health Organization or approved organization of international standards shall be followed.

(3) The Licensing Authority shall, from time to time, monitor and inspect the pharmacovigilance

activities mentioned in sub-section (1).

(4) If the pharmacovigilance program is not conducted effectively, the Licensing Authority may
temporarily suspend or cancel the license for the production or import of the drugs or the

registration of any drug of the concerned establishment.

67. Lot release of vaccines. — (1) Lot release certificate for all human vaccines, manufactured in

country and imported, shall be obtained from the Licensing Authority:

Provided, however, that the concerned 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 organization of the United Nations.

(2) Any specified vaccine may be marketed or supplied without lot release, subject to the prior

approval of the Licensing Authority, considering the importance, scarcity of time and urgency of

use in case of public health emergencies or disaster or emergency situation:

Provided, however, that the Lot Release Certificate shall 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 from the Licensing Authority may be obtained in lieu of lot release certificate.

68. Formulation of policies or guidelines, etc.—For carrying out the purposes of this Act, the

Government may, by issuing administrative orders or notifications, formulate necessary policies or

guidelines and determine the scope of work including formation of cells or committees.

Chapter XIII
General and Miscellaneous
69. Administrative measures to be taken by the Directorate. — (1) Notwithstanding anything to

the contrary contained in this Act, in case of taking any illegal activity concerning drugs and

cosmetics under this Act, if any offence mentioned in column (2) of the Schedule is committed in

contrast to the offences mentioned in column (1) of the Schedule, Serial No. 6, 7, 8, 9, 10, 14, 16,

18, 20, 21, 22, 25, 30, 31, 32, and 33, the Director General or any officer authorized thereby may, if

he thinks fit, take administrative measures relating to the imposition of fines and temporary or

permanent suspension of business activities without taking any action aimed at filing a criminal

case against the guilty person.

(2) In the case of imposition of fine in administrative proceedings under sub-section (1), no fine in

excess to the maximum fine under this Act for the offence concerned shall be imposed.

(3) In respect of any fine imposed in administrative proceedings under sub-sections (1) and (2),

imprisonment cannot be imposed in default.

(4) The fine imposed under this section shall be voluntarily paid by the guilty person within 5 (five)

working days.

(5) If the fine imposed in accordance with the provisions of sub-section (4) is not voluntarily paid by

the guilty person, the sentencing authority may recover the amount of fine imposed by attachment

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 additional 25 percent of the imposed fine may be recovered

as expenses.

70. Prohibition on Sale of Drugs on Public Ways. —No person shall sell, deliver free or offer to
deliver any allopathic, unani, ayurvedic, homeopathic and biochemical, herbal or any drug of

pharmaceutical specialty of any other description on any public way, highway, footpath, park or in

any public transport or in any vehicle.

71. Regulation of advertisements and claims relating to drugs and cosmetics. — (1) No person

shall, without the prior approval of the Licensing Authority, publish or promote any such

advertisement or participate in the publication or promotion of any advertisement, which contains

any claim relating to the use of drug or cure or treatment.

(2) A manufacturer, importer, marketer or seller of cosmetics shall not prepare, publish or circulate

any such advertisement which contains false or untrue claims regarding the use or results of use of

the cosmetics.

72. Prescription of unregistered drugs prohibited. — (1) No physician shall prescribe in his

prescription to any patient the use of any such drug not registered under this Act.

(2) For registered drugs which are imported after taking prior approval of the licensing authority,

the physician may give advice in his prescription.

73. Following the decisions of the Authorities listed by the World Health Organization. — The

Directorate may, if necessary, follow decisions of the Authorities listed by the World Health
Organization in respect of decisions to be taken thereby.

74. Application of Narcotics Control Act, 2018.—The Narcotics Control Act, 2018 (Act No. LXIII of

2018) shall be applicable in the case of import, export, production, stocking and sale of any

narcotic drugs or raw materials of drugs.

75. Acts in good faith. —No civil or criminal suit or any other legal proceedings shall be initiated or

instituted against the Directorate or any employee of the Directorate if any person is injured or is

likely to be injured as a result of any act carried out in good faith under this Act or the Rules.

76. Power to make rules. — (1) For carrying out the purposes of this Act, the Government may, by

notification in the Official Gazette, make rules:

Provided, however, that until rules are made or, as the case may be, orders are issued in respect of

manufacture, distribution, import, export and standardization and ancillary matters of cosmetics,

the existing arrangements relating to manufacture, distribution, import, export and

standardization and control of cosmetics under the existing systems in this regard, subject to

conformity with this Act, shall continue only through the concerned authorities.

77. Power of Government to remove difficulties. —If any difficulty arises in the implementation of

the provisions of this Act due to ambiguity regarding the powers and responsibilities of the

Directorate, the Government may, in consistent with the provisions of this Act, give directions

regarding the duties of the Directorate by clarifying or explaining the said provisions by Gazette
notification.

78. Taking co-operation and assistance of other organizations including law enforcement forces.

— In order to carrying any function for purpose of this Act, if necessary, if any letter is sent by the

Directorate seeking the cooperation and assistance of any relevant Agency or Authority including

law enforcement forces, the concerned forces, Agencies or Authorities shall provide necessary

cooperation and assistance to the Directorate.

79. Notification of seizure or detention to the superior officer and preservation of seized or

detained drugs and other articles. —If any drugs, cosmetics or relevant articles are seized or

detained under this Act in the prescribed manner, the concerned officer shall immediately apprise

of the list of such seized or detained articles to the superior officer in a written report shall be

submitted by the concerned officer in a written report and send a copy of the report to the

Director General and store the seized or detained articles in the designated place.

80. Obtaining expert opinion. — (1) For carrying out the purposes of this Act, if it appears to the

Directorate that there is a need to obtain a legal opinion or technical analysis or opinion on any

matter, the Directorate may request one or more persons who are experts, specialist or have

special knowledge or experience in the matter concerned to give opinion on such matters or invite

to attend meetings.

(2) The person providing the opinion referred to in sub-section (1) shall be paid appropriate

remuneration or honorarium at the prescribed rate, or in accordance with the rules and
regulations of the financial affairs of the Government.

81. Power to amend schedule. — For carrying out the purposes of this Act, the Government may,

by notification in the Official Gazette, amend the Schedule.

Chapter XIV
Repeal and Savings, etc.

82. Repeal and savings. — (1) Upon the commencement of the Act, Drugs Act, 1940 (Act XXIII of

1940) and Drugs (Control) Ordinance, 1982(Ordinance No. VIII of 1982), hereinafter referred to as

the said Act or Ordinance, is hereby repealed.

(2) Notwithstanding the repeal under sub-section (1)—

(a) rules, notification, orders, instructions, forms, circulars, approvals, etc. enacted,

issued or given under the said Act or Ordinance, as the case may be, subject to

being consistent with this Act, shall be deemed to have been enacted, issued or

given, as the case may be, under the similar provisions of this Act and shall
 remain in force until repealed, amended or re-enacted under this Act;

(b) If any action or proceeding under the said Act or Ordinance is pending

immediately before the enactment of this Act, the said action or proceeding

shall be disposed of in accordance with the provisions of the said Act or

Ordinance as if this Act had not been enacted.

(3) Notwithstanding the repeal under sub-section (1)—

(a) license, registration or Marketing Authorization Certificate given or issued by the

Licensing Authority or any act done, any action taken or any proceeding

instituted shall be deemed to be given, issued, done, taken or instituted under

this Act;

(b) the pending applications for licences or registrations shall be disposed of in the

manner in which they were disposed of before the enactment of this Act;

(c) cancelled or temporarily suspended license or registration or action taken or

proceedings instituted in the same manner shall be deemed to have been

cancelled, temporarily suspended, taken or instituted under this Act;

(d) if any suit or proceeding filed is pending or continuing, it shall be disposed of or

continued as if the said Act or Ordinance had not been repealed;

(e) the Drugs Court adjourned under the said Ordinance shall be deemed to have

been established as a Drugs Court subject to the provisions of this Act and cases

pending and continuing in the said Court shall be disposed of as if they were
 triable by the Drugs Court established under this Act;

(f) any agreement or memorandum of understanding, legal document or

instrument executed shall remain in force as if it had been executed under this

Act;

(g) the seized or detained drugs in which condition it is stored shall be stored as if it

had been stored under this Act.

(4) The officers and employees appointed under the said Act shall be employed on the same terms

and conditions under which they were employed, until modified or amended under this Act.

(5) All types of loans, liabilities, projects and legal obligations of the Government or Directorate

under the said Act or Ordinance shall be considered as loans, liabilities, projects and legal

obligations of the Government or Directorate under the same conditions as per the provisions of

this Act.

Publication of authentic English text. —

(1) After the commencement of this Act, the Government may, by notification in the Official

Gazette, publish an authentic English text of this Act.

(2) In case of conflict between the Bengali and English texts of this Act, the Bengali text shall

prevail.

Schedule
vide section 2(14)

Seria Sections Offences Punishment

l no.
(1) (2) (3) (4)
1. 14(1) Manufacturing of drugss without Rigorous imprisonment of either description
 obtaining a license or without
complying with the conditions
specified in the license.
2. 14(1) Selling, stocking, distributing or
exhibiting for sale of any drug
without obtaining a license or
without complying with the
conditions specified in the license.
3. 14(2) Using internet or web-based
process in selling, stocking,
distributing or exhibiting for sale
of any drug without a license or
without complying with
conditions specified in the license.
4. 14(3) Stocking drugss with the intention
of making more profit by creating
artificial shortage of drugss for
dishonest purposes.
5. 22(1) Manufacturing, importing,
exporting, selling, distributing,
stocking or exhibiting any drug
without obtaining registration.
6. 30(4) Selling any drug or raw materials
of manufacturing of drugs at a
price higher than the maximum
price as fixed.
7. 31(1) Manufacturing, distributing,
importing or exporting of
cosmetics without obtaining a
license or without complying with
the conditions specified in the
license.
8. 32(1) Manufacturing, distributing,
importing or exporting of
cosmetics without obtaining
registration.
9. 35(2) Applying Filler, Botox,
Glutathione or any similar
cosmetics to the human body by
injection or otherwise by a person
other than a physician registered
by the Bangladesh Medical and
Dental Council (BMDC) or
which may extend to 10(ten) years or with fine
not exceeding 10 (ten) lac taka or both.
Rigorous imprisonment of either description
which may extend to 5(five) years or with fine
not exceeding 5 (five) lac taka or both.
Rigorous imprisonment of either description
which may extend to 5(five) years or with fine
not exceeding 5 (five) lac taka or both.
Imprisonment for life or rigorous imprisonment
of either description which may extend to
10(ten) years or with fine not exceeding 10 (ten)
lac taka or both.
Rigorous imprisonment of either description
which may extend to 10(ten) years or with fine
not exceeding 10 (ten) lac taka or both.
Imprisonment of either description which may
extend to 2(two) years or with fine not
exceeding 2(two) lac taka or both.
Imprisonment of either description which may
extend to 1(one) year or with fine not exceeding
1(one) lac taka or both.
Imprisonment of either description which may
extend to 1(one) year or with fine not exceeding
1(one) lac taka or both.
Imprisonment of either description which may
extend to 6(six) months or with fine not
exceeding 3(three) lac taka or both.
 without supervision of such
physician.
10. 35(3) Violating the rules, application
and use of cosmetics by beauty
parlors
11. 36(1) Manufacturing, selling, stocking,
distributing, exhibiting for sale or
importing any drug which are not
of standard quality.
12. 36(2) As owner/proprietor or agent,
knowingly giving to the purchaser
a warranty regarding any drug
which is of below the standard
quality that the consumption or
use of such drugs does not affect
adversely and does not contravene
the provisions of this Act.
13. 37(1) Manufacturing, selling, stocking,
distributing or exhibiting for sale
of any misbranded drugs.
14. 37(1) Manufacturing, selling, stocking,
distributing or exhibiting for sale
of any misbranded cosmetics.
15. 38(1) Manufacturing any counterfeit
drug or knowingly selling,
stocking, distributing or exhibiting
for sale of any counterfeit drug.
16. 38(1) Manufacturing any counterfeit
cosmetics or knowingly selling,
stocking, distributing or exhibiting
for sale of any counterfeit
cosmetics.
17. 39(1) Adulteration of any drug or
manufacturing, selling, stocking,
distributing or exhibiting for sale
of any adulterated drugs.
18. 39(1) Adulteration of any cosmetics or
manufacturing, selling, stocking,
distributing or exhibiting for sale
of any adulterated cosmetics.
19. 40(a) Selling or stocking or exhibiting
for sale of Government drugss.
Imprisonment of either description which may
extend to 3(three) months or with fine not
exceeding 1(one) lac taka or both.
Rigorous imprisonment of either description
which may extend to 7(seven) years or with fine
not exceeding 10 (ten) lac taka or both.
Imprisonment of either description which may
extend to 1(one) year or with fine not exceeding
5(five) lac taka or both.
Rigorous imprisonment of either description
which may extend to 10(ten) years or with fine
not exceeding 10 (ten) lac taka or both.
Imprisonment of either description which may
extend to 1(one) year or with fine not exceeding
1(one) lac taka or both.
Rigorous imprisonment of either description
which may extend to 14(fourteen) years or with
fine not exceeding 10 (ten) lac taka or both.
Rigorous imprisonment of either description
which may extend to 5(five) years or with fine
not exceeding 5 (five) lac taka or both.
Rigorous imprisonment of either description
which may extend to 14(fourteen) years or with
fine not exceeding 10 (ten) lac taka or both.
Rigorous imprisonment of either description
which may extend to 5(five) years or with fine
not exceeding 5 (five) lac taka or both.
Rigorous imprisonment of either description
which may extend to 10(ten) years or with fine
 not exceeding 10 (ten) lac taka or both.

20. 40(b) Selling or stocking or exhibiting Imprisonment of either description which may
for sale of expired drugss and extend to 1(one) year or with fine not exceeding
drugss banned by the 50(fifty) thousand taka or both.
Government.

21. 40(c) Selling or stocking or exhibiting Fine not exceeding 10(ten) thousand taka.
for sale of physician sample types
drugss

22. 40(d) Selling of antibiotic or any other Fine not exceeding 20(twenty) thousand taka.
drugs without the prescription of a
registered physician other than
Over the Counter drugss.
23. 41(1) Importing drugs without license or Rigorous imprisonment of either description
beyond the conditions imposed which may extend to 10(ten) years or with fine
under the license. not exceeding 10 (ten) lac taka or both.

24. 41(2) Importing registered drugs Fine not exceeding 10 (ten) lac taka.
without the prior approval of the
Licensing Authority.

25. 42(1) Collecting raw materials of Fine not exceeding 20 (twenty) thousand taka.
registered drugss or packaging
material of drugss locally without
the prior approval of the
Licensing Authority.
26. 42(1) Importing raw materials of Fine not exceeding 10 (ten) lac taka.
registered drugss or packaging
material of drugss without the
prior approval of the Licensing
Authority.
27. 42(2) Importing Semi Finished drugss Fine not exceeding 10 (ten) lac taka.
or any other ingredient or material
necessary for the manufacture of
drugs without the prior approval
of the Licensing Authority.
28. 43(1) Exporting drugs without obtaining Imprisonment of either description which may
a license from the Licensing extend to 3(three) years or with fine not
Authority. exceeding 1(one) lac taka or both.
29. 48(2) Obstructing the inspector in the Fine not exceeding 3(three) lac taka.
exercise of his powers under this
Act....................

30. 52(6) Using the report or excerpt of that Fine not exceeding 2(two) lac taka.
report of test or analysis of
 National Control Laboratory or
Drugs Analyst as advertisement.
31. 70 Selling, delivering free or offering Imprisonment of either description which may
to deliver any allopathic, unani, extend to 2(two) years or with fine not
ayurvedic, homeopathic and exceeding 50(fifty) thousand taka or both.
biochemical, herbal or any drug of
pharmaceutical specialty of any
other description on any public
way, highway, footpath, park or in
any public transport or in any
vehicle.
32. 71(1) Without the prior approval of the Imprisonment of either description which may
Licensing Authority publishing or extend to 3(three) years or with fine not
promoting any such advertisement exceeding 5(five) lac taka or both.
or participating in the publication
or promotion of any
advertisement, which contains any
claim relating to the use of drugs
or cure or treatment

33. 71(2) Preparing, publishing or Fine not exceeding 3 (three) lac taka.
circulating any such
advertisement by the
manufacturer, importer, marketer
or seller of cosmetics which
contains false or untrue claims
regarding the use or results of use
of the cosmetics.