Pharmacy law and ethics
Pharmacy is the health profession related with drugs.
Law is enforced by the State and ethics is only moral being.
Terminology
Law
Law literally means a rule of action established by authority, a statute, the rules of a community or state etc. It is a pillar of human society and is necessary for each and every phase of life. Law and men are inseparable. It is an authoritative instrument which is always promulgated under government authority caring at its back a force for punishment.
Ethics
Ethics is the branch of philosophy and is the science of moral principle. It includes oaths of ethical conduct for men in all walks of life and professions relevant to their special needs. All written and unwritten principles which are expected in any profession as the basis of proper behavior, constitute the ethics of profession.
Law is enforced by the State and ethics is only moral being.
Forensic pharmacy
The term forensic means something pertaining to court of justice or to public disputation Forensic pharmacy is the legislative branch of pharmacy which deals with regulatory affairs, ordinances, acts and rules related to pharmaceuticals.
Ordinance
The term ordinance means a rule that is trained or established by the authority. It is an authoritative regulation, decree, law, or practice.
Act
An act is a formal transduction of legislative or other deliberative body.
Pharmacy Act and Pharmacy Ordinance 1976
To regulate and control the practice of pharmacy, pharmacy council of Bangladesh was established on the basis of Pharmacy Ordinance.
The ordinance describe:
1. Structure of pharmacy council
2. Function of pharmacy council
3. Qualification to get a registration of being a pharmacist
4. Prohibition of practice without registration
Structure of pharmacy council
According to the ordinance, the pharmacy council consists of the following members, namely:
a)The secretary of health population control and family planning department will be the president of the council. The Government can give appointment to any other person to be the president.
b)Director of health service, ex-officio.
c)Director or head of the department of drug administration, ex-officio.
d) Chairman or head of the Department of Pharmacy in the University of Dhaka, ex-officio.
e) Four persons to be nominated by the Government that one of them is a professor of Medicine and one is a Professor of Pharmacology of medical institution in Bangladesh, one is qualified pharmacist and the other person is nominated by the Government.
f) One qualified pharmacist to be nominated by the Bangladesh Aushad Shilpa Samity.
g) One person to be nominated by the Bangladesh Medical Association.
h) One qualified pharmacist to be nominated by the Bangladesh Chemists and Druggists Samity.
i) Three persons to be nominated by the Pharmaceutical Society of Bangladesh registered under the Societies Registration Act, 1860 (XXI of 1860).
According to the ordinance the Government may increase or decrease the number of persons to be nominated by notification in the official Gazette.
Functions of the Pharmacy Council
The functions of the pharmacy council are as follows:
a)To approve examinations in pharmacy for the purpose of qualified persons for registration as pharmacists.
b)To prescribe the subjects in which approved examinations will be held.
c)To approve the courses of study and practical training in pharmacy, so as to fill up the purpose of admission to approved examination.
d) To prescribe the conditions and procedure for admission of candidates to an approved examination.
e) To lay down the standard of teaching to be maintained by institutions conducting the approved courses of study
f) To prescribe the equipment and facilities to be made available to the students.
g) To recognize degree or diploma in pharmacy for the purpose of registration as pharmacists.
h) To cause inspection of institutions which conduct any course of study in pharmacy and of the teachings imparted and examinations held by them.
i) To prepare and maintain Registers of pharmacists and apprentices in pharmacy.
j) To register pharmacists and grant certificates of registration.
k) To hold examinations for the purpose of registration as pharmacists, and
l) To do such other acts and things as it may be empowered or required to do by or under this Ordinance.
Qualification for registration as a pharmacist or as an apprentice in pharmacy
In order to maintain due standards in the profession, the privileges of the profession of pharmacy are only restricted to persons having proper scientific and professional knowledge. For this reason registration of pharmacists is necessary. Such registration not only restricts the persons entering the profession but also provides them various privileges and makes them aware of their duties and responsibilities.
The following persons shall be qualified for registration as a pharmacist under this ordinance, namely:
a. Persons who hold a degree in pharmacy conferred by a university or an institution affiliated thereto, where the degree is recognized by the council (pharmacy council of Bangladesh).
b. Persons who hold a diploma in pharmacy recognized by the council.
c. Persons who pass the examination in pharmacy held or approved by the council.
Provide that during the period of two years from the coming into force of this Ordinance, The following persons shall also be deemed to be qualified for registration, namely;
i. Graduates in pharmacy from a university or an institution affiliated thereto.
ii. Graduates in science from a university or an institution affiliated thereto, with chemistry or pharmaceutical chemistry or pharmacology or microbiology as the principal subject, who are engaged for at least two years in the manufacture or test and analysis of drugs and medicines in any drug manufacturing concern licensed under the Drug Act, 1940 (XXIII of 1940), or in any Government institution or laboratory.
iii. Inspectors of drugs appointed under Drugs Act, 1940 (XXIII of 1940), and Government Analysts so appointed.
iv. Teachers in any subject related to pharmacy in any institution conducting courses of study in pharmacy.
v. Persons who hold diploma in pharmacy recognized for registration under the Pharmacy Act, 1976.
vi. Persons who had been approved by the licensing authority on or before the 30th November, 1974, as “qualified persons” within the meaning of rule 24 of the Drugs Rules, 1946.
vii. Persons engaged in compounding or dispensing medicine in a Government Hospital; and,
viii. Persons qualified as compounders and dispensers of medicine by a Government Hospital.
No person shall be qualified for registration as a pharmacist or as an apprentice in pharmacy-
(a) if he is of unsound mind and stands so declared by a court ; or
(b) if he has been convicted by a court of any offence which in the opinion of the Council involves moral turpitude.
Prohibition of practice without registration
1). Subject to the provisions of sub-section (4), no person shall, after the expiry of two years from the coming into force of this Ordinance, or such later date as the Government may, by notification in the official Gazette, specify in this behalf, practice as a pharmacist unless he is a registered pharmacist and displays his certificate of registration in a conspicuous place within the premises in which he so practises.
2). Whoever employs any pharmacist for the purpose of any business in pharmacy shall cause (amended for ‘cease’) the certificate of registration of the pharmacist so employed to be displayed in a conspicuous place within the premises in which such business is carried on
3). Whoever contravenes the provisions of sub-section (1) or sub-section (2) shall be punishable, on first conviction, with fine which may extend to Taka five hundred, and, on each subsequent conviction with imprisonment for a term which may extend to three months, or with fine which may extend to Taka five hundred, or with both.
4). Nothing in sub-section (1) shall apply to—
(a) a registered medical practitioner as defined in the Medical Council Act, 1973 (XXX of 1973), or a person authorised to prescribe antibiotic and dangerous drugs under the Allopathic System (Prevention of Misuse) Ordinance, 1962 (LXV of 1962), who dispenses medicine to his own patients or serves his own prescriptions;
(b) a person who deals in non-poisonous household remedies in original and unopened container at any store or place or prepares non-poisonous household remedies in accordance with the rules made under the Drugs Act, 1940 (XXIII of 1940);
(c) a person who manufactures, sells or distributes drugs and medicines which fall exclusively under the unani, ayurvedic, bio-chemic or homeopathic system of medicine;
(d) a person engaged as a health or veterinary technician in a Government Hospital or institution ; and
(e) a foreign pharmacist who is engaged, with the approval of the Council, for the purposes of consultation, advice or instruction.
Definition of pharmacist according to drug ordinance 1976
According to this ordinance “pharmacist” means a person who, for a fee, salary or other consideration paid to him or to another person on his behalf, manufactures, prepares, distributes, sells, or serves any prescription for, any medicine, drug or pharmaceutical preparation.
Drug Control Ordinance 1982/ Drug Ordinance 1982
To control the manufacturer, import, distribution and sales of drugs the Government of People Republic of Bangladesh have published an ordinance on 12th June 1982 which is known as ‘Drug Control Ordinance 1982.
Before this ordinance the manufacturing, marketing and distribution of drugs were regulated by drug act 1940. But when Drug Control Ordinance 1982 came into force, a number of pharmaceutical products harmful for health were banned. Examples of such products include,
i. Liquid vitamin B complex
ii. Narcotic cough syrup
iii. Phencidil
iv. Blood alkalizer
v. Gripe water
vi. Various types of ointments
vii. Liquid enzymes
viii. Other items containing higher percentage of alcohol
Brief description of Drug Control Ordinance 1982
4. Drug Control Committee
(1) The Government shall constitute a Drug Control Committee consisting of a Chairman and such other members as it may appoint from time to time.
(2) The Committee shall perform such functions as are specified in this Ordinance
5. Registration of Medicines.
(1) No medicine of any kind shall be manufactured for sale or be imported, distributed or sold unless it is registered with the licencing authority.
(2) The licencing authority shall not register a medicine unless such registration is recommended by the Committee.
(3) A registration shall be granted on such conditions as may be specified by the licencing authority.
(4) A registration shall, unless cancelled earlier, be valid for a period of five years.
6. Cancellation or suspension of registration.
(1) The licencing authority may cancel the registration of any medicine if the Committee recommends such cancellation.
(2) The Committee shall evaluate every medicine registered before the commencement of this Ordinance and every medicine that may be manufactured or imported after such commencement in order to determine its safety, efficacy and usefulness.
(3) If on such evaluation the Committee finds that any such medicine is not sale, efficacious or useful it may recommend to the licencing authority cancellation of registration of the medicine.
(4) The licencing authority may, if it is satisfied that a medicine is substandard, suspend the registration of such medicine till he is satisfied that the medicine has attained its standared
7. Fees for registration.
No registration of a medicine shall be granted unless a fee to be determined by the Government is paid at the time of application for registration.
8. Prohibition of Manufacture, etc, of certain medicines.
(1) On the commencement of this Ordinance, the registration or licence in respect of all medicines mentioned in the Schedules shall stand cancelled, and no such medicine shall, subject to the provisions of sub-section (2), be manufactured, imported, distributed or sold after such commencement.
(2) Notwithstanding anything contained in sub-section (1),—
(a) the medicines specified in Schedule I shall be destroyed within three months from the date of commencement of this Ordinance ;
(b) the medicines specified in Schedule II may be manufactured or sold for a period of six months from the date of commencement of this Ordinance and thereafter their manufacture and sale shall be permitted only if they are registered alter change in their formulation in accordance with the direction of the licencing authority;
(c) the medicines specified in Schedule III may be manufactured, imported, distributed and sold for a period of nine months after the commencement of this Ordinance, and thereafter there shall not be any manufacture, import, distribution or sale of such medicines.
9. Restriction on import of certain pharmaceutical raw material.
(1) No pharmaceutical raw material necessary for the manufacture of any medicine specified in any of the Schedules shall be imported.
(2) No drug or pharmaceutical raw material shall be imported except with the prior approval of the licencing authority.
(3) The licencing authority may award an approval under sub-section (2) on such conditions as it deems fit to specify.
10. Restriction on manufacture of certain drugs under licence.
No drug shall, alter six months from the date of commencement of this Ordinance, be manufactured in Bangladesh under licence granted by a foreign company having no manufacturing plant in Bangladesh if, such drug or its substitute is produced in Bangladesh.
11. Fixation of price of drugs.
(1) The Government may, by notification in the official Gazette, fix the maximum price at which any medicine may be sold.
(2) The Government may by notification in the official Gazette, fix the maximum price at which any pharmaceutical raw material may be imported or sold.
13. Employment of pharmacists.
(i) No person shall manufacture any drug except under the personal supervision of a pharmacist registered in Register 'A' of the Pharmacy Council of Bangladesh:
Provided that this provision shall not apply to the manufacture of any drug under the ayurvedic, unani, or homeopathic or biochemic system of medicine.
(2) No person, being a retailer, shall sell any drug without the personal supervision of a pharmacist registered in any Register of the Pharmacy Council of Bangladesh:
Provided that this provision shall not apply to the retail sale of any drug under the ayurvedic, unani, or homeopathic or biochemic system of medicine.
15. Good practices in the manufacturer and quality control of drugs.
(1) Every manufacturer of drugs shall follow the good practices in the manufacture and quality control of drugs recommended by the World Health Organisation.
(2) If any manufacturer does not follow such good practices his manufactured licence may be cancelled or suspended.
16. Penalty for manufacture, etc., of certain drugs.
Whoever manufactures, imports, distributes or sells—
(a) any medicine which is not registered under this Ordinance, or
(b) any medicine in contravention of the provisions of section 8, or
(c) any drug which is adulterated or spurious.
shall be punishable with rigorous imprisonment for a term which may extend to ten years, or with fine which may extend to two lac taka, or with both, and any implements used in the manufacture or sale of such medicine or drug may, by order of the Drug Court, be forfeited to the Government.
17. Penalty for manufacture or sale of sub-standard drugs.
Whoever manufactures or sells any sub-standard drug shall be punishable with rigorous imprisonment for a term which may extend to live years, or with fine which may extend to one lac taka, or with both.
18. Penalty for un-authorised import of drugs.
Whoever imports any drug or pharmaceutical raw material without the prior approval of the licencing authority shall be punishable with rigorous imprisonment for a term which may extend to three years, or with fine which may extend to fifty thousand taka, or with both and such drug or raw material may be order of the Drug Court, be forfeited to the Government.
19. Penalty for sale of medicine or import or sale of pharmaceutical raw material at a higher price.
Whoever sells any medicine or imports or sells any pharmaceutical raw material
at a price higher than the maximum price fixed by the Government under section 11 shall be punishable with rigorous imprisonment for a term which may extend to two years, or with fine which any extend to ten thousand taka, or with both.
20. Penalty for theft, etc., of Government drugs.
Whoever commits theft in respect of any drug in any Government store, hospital, clinic or health centre or sells any such drug or keeps in his possession any such drug for sale shall be punishable with rigorous imprisonment for a term which may extend to ten years, or with fine which may extend to two lac taka or with both.
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21. Penalty for illegal advertisement and claims.
Whoever contravenes the provision of section 14 shall be punishable with fine which may extend to twenty-five thousand taka.
2. Drug Courts.
(1) The Government may, by notification in the official Gazette establish as many Drug Courts as it considers necessary and where it establishes more than one Drug Court shall specify in the notification the territorial limits within which each one of them shall exercise jurisdiction under this Ordinance.
(2) A Drug Court shall consist of a person who is or has been a Sessions Judge and he shall be appointed by the Government.
(3) A Drug Court shall sit at such place as the Government may direct.
(4) A Drug Court may pass any sentence authorised by this Ordinance and shall have all the powers conferred by the Code of Criminal Procedure, 1898 (V of 1898), on a Court of Session exercising original jurisdiction.
(5) A Drug Court shall not, merely by reason of a change in its composition, be bound to recall and rehear any witness who has given evidence, and may act on the evidence already recorded by or produced before it.
(6) A Drug Court shall, in all matters with respect to which no procedure has been prescribed by this Ordinance, follow the procedure prescribed by the Code of Criminal Procedure, 1898 (V of 1898). for the trial of summons cases by Magistrates.
(7) A. Drug Court may, on application in ill is behalf being made by the prosecution.try an offence under this Ordinance summarily in accordance win the provisions contained in sections 262 to 265 ol the Code of Criminal Procedure, 1898 (V of 1898).
(8) An appeal from the judgement of a Drug Court shall lie to the High Court Division.
24. National Drug Advisory Council,
(1) The Government shall constitute a National Drug Advisory Council consisting of a Chairman and such oilier members as it may appoint from time to time.
(2) The Council shall advise the Government on—
(a) measures to be adopted for the implementation of the national drug policy that may be adopted by the Government from time to time;
(b) measures for the promotion of local pharmaceutical industries and production and supply of essential drugs for meeting the needs of the country.
(c) matters relating to the import of drugs and pharmaceutical raw materials.
(d) measures for the co-ordination of the activities of the various Ministries, agencies and persons dealing with manufacture, import, distribution and sale of drugs.
25. Power to make rules.
The Government may, be notification in the official Gazette, make rules for carrying out the purposes of this Ordinance.
Law is enforced by the State and ethics is only moral being.
Terminology
Law
Law literally means a rule of action established by authority, a statute, the rules of a community or state etc. It is a pillar of human society and is necessary for each and every phase of life. Law and men are inseparable. It is an authoritative instrument which is always promulgated under government authority caring at its back a force for punishment.
Ethics
Ethics is the branch of philosophy and is the science of moral principle. It includes oaths of ethical conduct for men in all walks of life and professions relevant to their special needs. All written and unwritten principles which are expected in any profession as the basis of proper behavior, constitute the ethics of profession.
Law is enforced by the State and ethics is only moral being.
Forensic pharmacy
The term forensic means something pertaining to court of justice or to public disputation Forensic pharmacy is the legislative branch of pharmacy which deals with regulatory affairs, ordinances, acts and rules related to pharmaceuticals.
Ordinance
The term ordinance means a rule that is trained or established by the authority. It is an authoritative regulation, decree, law, or practice.
Act
An act is a formal transduction of legislative or other deliberative body.
Pharmacy Act and Pharmacy Ordinance 1976
To regulate and control the practice of pharmacy, pharmacy council of Bangladesh was established on the basis of Pharmacy Ordinance.
The ordinance describe:
1. Structure of pharmacy council
2. Function of pharmacy council
3. Qualification to get a registration of being a pharmacist
4. Prohibition of practice without registration
Structure of pharmacy council
According to the ordinance, the pharmacy council consists of the following members, namely:
a)The secretary of health population control and family planning department will be the president of the council. The Government can give appointment to any other person to be the president.
b)Director of health service, ex-officio.
c)Director or head of the department of drug administration, ex-officio.
d) Chairman or head of the Department of Pharmacy in the University of Dhaka, ex-officio.
e) Four persons to be nominated by the Government that one of them is a professor of Medicine and one is a Professor of Pharmacology of medical institution in Bangladesh, one is qualified pharmacist and the other person is nominated by the Government.
f) One qualified pharmacist to be nominated by the Bangladesh Aushad Shilpa Samity.
g) One person to be nominated by the Bangladesh Medical Association.
h) One qualified pharmacist to be nominated by the Bangladesh Chemists and Druggists Samity.
i) Three persons to be nominated by the Pharmaceutical Society of Bangladesh registered under the Societies Registration Act, 1860 (XXI of 1860).
According to the ordinance the Government may increase or decrease the number of persons to be nominated by notification in the official Gazette.
Functions of the Pharmacy Council
The functions of the pharmacy council are as follows:
a)To approve examinations in pharmacy for the purpose of qualified persons for registration as pharmacists.
b)To prescribe the subjects in which approved examinations will be held.
c)To approve the courses of study and practical training in pharmacy, so as to fill up the purpose of admission to approved examination.
d) To prescribe the conditions and procedure for admission of candidates to an approved examination.
e) To lay down the standard of teaching to be maintained by institutions conducting the approved courses of study
f) To prescribe the equipment and facilities to be made available to the students.
g) To recognize degree or diploma in pharmacy for the purpose of registration as pharmacists.
h) To cause inspection of institutions which conduct any course of study in pharmacy and of the teachings imparted and examinations held by them.
i) To prepare and maintain Registers of pharmacists and apprentices in pharmacy.
j) To register pharmacists and grant certificates of registration.
k) To hold examinations for the purpose of registration as pharmacists, and
l) To do such other acts and things as it may be empowered or required to do by or under this Ordinance.
Qualification for registration as a pharmacist or as an apprentice in pharmacy
In order to maintain due standards in the profession, the privileges of the profession of pharmacy are only restricted to persons having proper scientific and professional knowledge. For this reason registration of pharmacists is necessary. Such registration not only restricts the persons entering the profession but also provides them various privileges and makes them aware of their duties and responsibilities.
The following persons shall be qualified for registration as a pharmacist under this ordinance, namely:
a. Persons who hold a degree in pharmacy conferred by a university or an institution affiliated thereto, where the degree is recognized by the council (pharmacy council of Bangladesh).
b. Persons who hold a diploma in pharmacy recognized by the council.
c. Persons who pass the examination in pharmacy held or approved by the council.
Provide that during the period of two years from the coming into force of this Ordinance, The following persons shall also be deemed to be qualified for registration, namely;
i. Graduates in pharmacy from a university or an institution affiliated thereto.
ii. Graduates in science from a university or an institution affiliated thereto, with chemistry or pharmaceutical chemistry or pharmacology or microbiology as the principal subject, who are engaged for at least two years in the manufacture or test and analysis of drugs and medicines in any drug manufacturing concern licensed under the Drug Act, 1940 (XXIII of 1940), or in any Government institution or laboratory.
iii. Inspectors of drugs appointed under Drugs Act, 1940 (XXIII of 1940), and Government Analysts so appointed.
iv. Teachers in any subject related to pharmacy in any institution conducting courses of study in pharmacy.
v. Persons who hold diploma in pharmacy recognized for registration under the Pharmacy Act, 1976.
vi. Persons who had been approved by the licensing authority on or before the 30th November, 1974, as “qualified persons” within the meaning of rule 24 of the Drugs Rules, 1946.
vii. Persons engaged in compounding or dispensing medicine in a Government Hospital; and,
viii. Persons qualified as compounders and dispensers of medicine by a Government Hospital.
No person shall be qualified for registration as a pharmacist or as an apprentice in pharmacy-
(a) if he is of unsound mind and stands so declared by a court ; or
(b) if he has been convicted by a court of any offence which in the opinion of the Council involves moral turpitude.
Prohibition of practice without registration
1). Subject to the provisions of sub-section (4), no person shall, after the expiry of two years from the coming into force of this Ordinance, or such later date as the Government may, by notification in the official Gazette, specify in this behalf, practice as a pharmacist unless he is a registered pharmacist and displays his certificate of registration in a conspicuous place within the premises in which he so practises.
2). Whoever employs any pharmacist for the purpose of any business in pharmacy shall cause (amended for ‘cease’) the certificate of registration of the pharmacist so employed to be displayed in a conspicuous place within the premises in which such business is carried on
3). Whoever contravenes the provisions of sub-section (1) or sub-section (2) shall be punishable, on first conviction, with fine which may extend to Taka five hundred, and, on each subsequent conviction with imprisonment for a term which may extend to three months, or with fine which may extend to Taka five hundred, or with both.
4). Nothing in sub-section (1) shall apply to—
(a) a registered medical practitioner as defined in the Medical Council Act, 1973 (XXX of 1973), or a person authorised to prescribe antibiotic and dangerous drugs under the Allopathic System (Prevention of Misuse) Ordinance, 1962 (LXV of 1962), who dispenses medicine to his own patients or serves his own prescriptions;
(b) a person who deals in non-poisonous household remedies in original and unopened container at any store or place or prepares non-poisonous household remedies in accordance with the rules made under the Drugs Act, 1940 (XXIII of 1940);
(c) a person who manufactures, sells or distributes drugs and medicines which fall exclusively under the unani, ayurvedic, bio-chemic or homeopathic system of medicine;
(d) a person engaged as a health or veterinary technician in a Government Hospital or institution ; and
(e) a foreign pharmacist who is engaged, with the approval of the Council, for the purposes of consultation, advice or instruction.
Definition of pharmacist according to drug ordinance 1976
According to this ordinance “pharmacist” means a person who, for a fee, salary or other consideration paid to him or to another person on his behalf, manufactures, prepares, distributes, sells, or serves any prescription for, any medicine, drug or pharmaceutical preparation.
Drug Control Ordinance 1982/ Drug Ordinance 1982
To control the manufacturer, import, distribution and sales of drugs the Government of People Republic of Bangladesh have published an ordinance on 12th June 1982 which is known as ‘Drug Control Ordinance 1982.
Before this ordinance the manufacturing, marketing and distribution of drugs were regulated by drug act 1940. But when Drug Control Ordinance 1982 came into force, a number of pharmaceutical products harmful for health were banned. Examples of such products include,
i. Liquid vitamin B complex
ii. Narcotic cough syrup
iii. Phencidil
iv. Blood alkalizer
v. Gripe water
vi. Various types of ointments
vii. Liquid enzymes
viii. Other items containing higher percentage of alcohol
Brief description of Drug Control Ordinance 1982
4. Drug Control Committee
(1) The Government shall constitute a Drug Control Committee consisting of a Chairman and such other members as it may appoint from time to time.
(2) The Committee shall perform such functions as are specified in this Ordinance
5. Registration of Medicines.
(1) No medicine of any kind shall be manufactured for sale or be imported, distributed or sold unless it is registered with the licencing authority.
(2) The licencing authority shall not register a medicine unless such registration is recommended by the Committee.
(3) A registration shall be granted on such conditions as may be specified by the licencing authority.
(4) A registration shall, unless cancelled earlier, be valid for a period of five years.
6. Cancellation or suspension of registration.
(1) The licencing authority may cancel the registration of any medicine if the Committee recommends such cancellation.
(2) The Committee shall evaluate every medicine registered before the commencement of this Ordinance and every medicine that may be manufactured or imported after such commencement in order to determine its safety, efficacy and usefulness.
(3) If on such evaluation the Committee finds that any such medicine is not sale, efficacious or useful it may recommend to the licencing authority cancellation of registration of the medicine.
(4) The licencing authority may, if it is satisfied that a medicine is substandard, suspend the registration of such medicine till he is satisfied that the medicine has attained its standared
7. Fees for registration.
No registration of a medicine shall be granted unless a fee to be determined by the Government is paid at the time of application for registration.
8. Prohibition of Manufacture, etc, of certain medicines.
(1) On the commencement of this Ordinance, the registration or licence in respect of all medicines mentioned in the Schedules shall stand cancelled, and no such medicine shall, subject to the provisions of sub-section (2), be manufactured, imported, distributed or sold after such commencement.
(2) Notwithstanding anything contained in sub-section (1),—
(a) the medicines specified in Schedule I shall be destroyed within three months from the date of commencement of this Ordinance ;
(b) the medicines specified in Schedule II may be manufactured or sold for a period of six months from the date of commencement of this Ordinance and thereafter their manufacture and sale shall be permitted only if they are registered alter change in their formulation in accordance with the direction of the licencing authority;
(c) the medicines specified in Schedule III may be manufactured, imported, distributed and sold for a period of nine months after the commencement of this Ordinance, and thereafter there shall not be any manufacture, import, distribution or sale of such medicines.
9. Restriction on import of certain pharmaceutical raw material.
(1) No pharmaceutical raw material necessary for the manufacture of any medicine specified in any of the Schedules shall be imported.
(2) No drug or pharmaceutical raw material shall be imported except with the prior approval of the licencing authority.
(3) The licencing authority may award an approval under sub-section (2) on such conditions as it deems fit to specify.
10. Restriction on manufacture of certain drugs under licence.
No drug shall, alter six months from the date of commencement of this Ordinance, be manufactured in Bangladesh under licence granted by a foreign company having no manufacturing plant in Bangladesh if, such drug or its substitute is produced in Bangladesh.
11. Fixation of price of drugs.
(1) The Government may, by notification in the official Gazette, fix the maximum price at which any medicine may be sold.
(2) The Government may by notification in the official Gazette, fix the maximum price at which any pharmaceutical raw material may be imported or sold.
13. Employment of pharmacists.
(i) No person shall manufacture any drug except under the personal supervision of a pharmacist registered in Register 'A' of the Pharmacy Council of Bangladesh:
Provided that this provision shall not apply to the manufacture of any drug under the ayurvedic, unani, or homeopathic or biochemic system of medicine.
(2) No person, being a retailer, shall sell any drug without the personal supervision of a pharmacist registered in any Register of the Pharmacy Council of Bangladesh:
Provided that this provision shall not apply to the retail sale of any drug under the ayurvedic, unani, or homeopathic or biochemic system of medicine.
15. Good practices in the manufacturer and quality control of drugs.
(1) Every manufacturer of drugs shall follow the good practices in the manufacture and quality control of drugs recommended by the World Health Organisation.
(2) If any manufacturer does not follow such good practices his manufactured licence may be cancelled or suspended.
16. Penalty for manufacture, etc., of certain drugs.
Whoever manufactures, imports, distributes or sells—
(a) any medicine which is not registered under this Ordinance, or
(b) any medicine in contravention of the provisions of section 8, or
(c) any drug which is adulterated or spurious.
shall be punishable with rigorous imprisonment for a term which may extend to ten years, or with fine which may extend to two lac taka, or with both, and any implements used in the manufacture or sale of such medicine or drug may, by order of the Drug Court, be forfeited to the Government.
17. Penalty for manufacture or sale of sub-standard drugs.
Whoever manufactures or sells any sub-standard drug shall be punishable with rigorous imprisonment for a term which may extend to live years, or with fine which may extend to one lac taka, or with both.
18. Penalty for un-authorised import of drugs.
Whoever imports any drug or pharmaceutical raw material without the prior approval of the licencing authority shall be punishable with rigorous imprisonment for a term which may extend to three years, or with fine which may extend to fifty thousand taka, or with both and such drug or raw material may be order of the Drug Court, be forfeited to the Government.
19. Penalty for sale of medicine or import or sale of pharmaceutical raw material at a higher price.
Whoever sells any medicine or imports or sells any pharmaceutical raw material
at a price higher than the maximum price fixed by the Government under section 11 shall be punishable with rigorous imprisonment for a term which may extend to two years, or with fine which any extend to ten thousand taka, or with both.
20. Penalty for theft, etc., of Government drugs.
Whoever commits theft in respect of any drug in any Government store, hospital, clinic or health centre or sells any such drug or keeps in his possession any such drug for sale shall be punishable with rigorous imprisonment for a term which may extend to ten years, or with fine which may extend to two lac taka or with both.
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21. Penalty for illegal advertisement and claims.
Whoever contravenes the provision of section 14 shall be punishable with fine which may extend to twenty-five thousand taka.
2. Drug Courts.
(1) The Government may, by notification in the official Gazette establish as many Drug Courts as it considers necessary and where it establishes more than one Drug Court shall specify in the notification the territorial limits within which each one of them shall exercise jurisdiction under this Ordinance.
(2) A Drug Court shall consist of a person who is or has been a Sessions Judge and he shall be appointed by the Government.
(3) A Drug Court shall sit at such place as the Government may direct.
(4) A Drug Court may pass any sentence authorised by this Ordinance and shall have all the powers conferred by the Code of Criminal Procedure, 1898 (V of 1898), on a Court of Session exercising original jurisdiction.
(5) A Drug Court shall not, merely by reason of a change in its composition, be bound to recall and rehear any witness who has given evidence, and may act on the evidence already recorded by or produced before it.
(6) A Drug Court shall, in all matters with respect to which no procedure has been prescribed by this Ordinance, follow the procedure prescribed by the Code of Criminal Procedure, 1898 (V of 1898). for the trial of summons cases by Magistrates.
(7) A. Drug Court may, on application in ill is behalf being made by the prosecution.try an offence under this Ordinance summarily in accordance win the provisions contained in sections 262 to 265 ol the Code of Criminal Procedure, 1898 (V of 1898).
(8) An appeal from the judgement of a Drug Court shall lie to the High Court Division.
24. National Drug Advisory Council,
(1) The Government shall constitute a National Drug Advisory Council consisting of a Chairman and such oilier members as it may appoint from time to time.
(2) The Council shall advise the Government on—
(a) measures to be adopted for the implementation of the national drug policy that may be adopted by the Government from time to time;
(b) measures for the promotion of local pharmaceutical industries and production and supply of essential drugs for meeting the needs of the country.
(c) matters relating to the import of drugs and pharmaceutical raw materials.
(d) measures for the co-ordination of the activities of the various Ministries, agencies and persons dealing with manufacture, import, distribution and sale of drugs.
25. Power to make rules.
The Government may, be notification in the official Gazette, make rules for carrying out the purposes of this Ordinance.
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