3206 law & ethics manik

Md. Imran Nur Manik

Md. Imran Nur Manik

Pharmacy Law & Ethics-I

Prepared By: Md. Imran Nur Manik; M.Pharm. (R.U.) Page 1 [email protected]; Lecturer; Department of Pharmacy; Primeasia University.


Terminologies

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

behaviour 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.

The Directorate General of Drug Administration

The Directorate General of Drug Administration under the Ministry of Health & Family Welfare, Government of the People's Republic of Bangladesh is the Drug Regulatory Authority of the country.

General Description At present, there are 278 Allopathic, 206 Ayurvedic, 266 Unani, 32 Herbal and 79 Homeopathic drug manufacturing companies in the country. The Directorate General of Drug Administration monitors and regulates all the activities of these 854 companies.

Md. Imran Nur Manik

Md. Imran Nur Manik



The chief of the Directorate, designated as the Director General, is also empowered by the Govt. to act as the Licensing Authority (LA) of drugs for the purpose of issuing licenses to manufacture, store, sell, import and export drugs and medicines. Drug Testing Laboratory: Testing of drugs are required for evaluating pre-registration and post-marketed drugs and medicines quality. At present, there are two Govt. Drug Testing Laboratories in the country, one in Chittagong and another in Dhaka. At present, there are 47 district offices of the Directorate in the country. All officers of the Directorate function as "Drug Inspector" pursuant to the Drug Laws and assist the Licensing Authority for properly discharging his responsibilities. Besides, a number of Committees, such as Drug Control Committee (DCC), Standing Committee for procurement and import of raw materials and finished drugs, Pricing Committee and a number of other relevant Committees, which comprise of experts, are there to advise the Licensing Authority and to recommend to him matters related to drugs and medicines.

Historical background Before 1971 -An organization under the Central Govt. of Pakistan under the Controller of drugs. After the war of liberation- An attached department of the Ministry of Health and Population Control. Since 1976 -A separate Directorate directly under the Ministry of Health and Family Welfare, 17 January 2010 upgraded as the Directorate General of Drug Administration.

Mission Statement

The Directorate General of Drug Administration mission is to ensure that the common people have easy access to useful, effective, safe and good quality essential and other drugs at affordable price. Directorate General of Drug Administration (DGDA) is the organization entrusted with the responsibility of ensuring the quality, efficacy and safety of pharmaceutical products though the implementation of relevant legislation.

Responsibilities The responsibilities of this organization are as follows: a. To ensure the quality, safety, efficacy and usefulness of all kinds of drugs and medicines including Homeopathic, Unani, Ayurvedic and Herbal drugs which are produced , imported and marketed in the country and also exported to overseas. b. To make essential drugs available and affordable to the common people of the country. c. Supervision and implementation of all prevailing Drug Regulations in the country and regulates all activities related to import, procurement of raw and packing materials, production and import of finished drugs, export, sale, pricing, etc. of all kinds of medicine including those of Ayurvedic, Unani, Herbal and Homoeopathic systems.

Md. Imran Nur Manik

Md. Imran Nur Manik



Major Function of DGDA

The functions of DGDA are as follows,

1. Evaluation of the proposals of new projects of all systems of medicines.

2. Issue and renewal of drug manufacturing licenses.

3. Issue and renewal of retail and whole sale drug licenses.

4. Registration and renewal of drug products.

5. Fixation of price and certification of price for drug products.

6. Inspection of pharmaceutical establishments

7. Approval of block list for the import of raw- and packaging materials.

8. Approval of indent for import of finished drugs.

9. Surveillance and pharmacovigillance activity

10. Prosecution of cases in the drug courts and other courts

11. Issue of export licenses, FSC (Free Sales Certificate), GMP (Good Manufacturing Practices)

Certificate & CPP ( Certificate for Pharmaceutical Products.)

Legislation () All the activities of DGDA are governed & guided by * The Drug Act 1940 * The Drug Rules 1945 and their amendments * The Drug Rules 1946 and their amendments * The Drug (Control) Ordinance 1982 and its amendments * The Drug (Control) Ordinance Amendment Act 2006 * National Drug Policy 2005 The Ordinance provides for the following legislative ( ) powers and responsibilities with respect to drugs and medicines:

1. Formation of a Committee of experts, called the DCC or Drug Control Committee, for consideration of registration of medicines and/or their cancellation. 2. Prohibition of manufacture and sale of drugs without the supervision of pharmacists. 3. Restriction on import of certain pharmaceuticals and finished drugs. 4. Review of under-licensing agreements. 5. Fixation of prices of essential drugs. 6. Control of advertisements and claims in respect of drugs. 7. Implementation of GMP in the manufacturing units as recommended by WHO. 8. Formation of Drug Courts for trying offenses related to drugs. 9. Formation of a National Drug Advisory Council for advising the Govt. on matters related to essential drugs.

Md. Imran Nur Manik

Md. Imran Nur Manik



10. Formation of an Appellate Authority. 11. Recognition of Traditional and Homeopathic medicines as drugs. 12. Imposition of penalty for : - manufacture and sale of adulterated, spurious and restricted drugs. - manufacture and sale of substandard drugs. - unauthorized import of drugs and raw materials. - sale of medicines at prices higher than the Maximum Retail Price (MRP) by the Licensing Authority. - theft of Drugs from Govt. hospitals and stores. - illegal advertisement of drugs and claims about their qualities and uses.

Pharmacy Ordinance 1976

The Pharmacy Council of Bangladesh (PCB) is an Autonomous Organization under the Ministry of

Health and Family Welfare, Govt. of the People's Republic of Bangladesh. It was established

under the Pharmacy Ordinance, Ordinance No. X111 of 1976.

Pharmacy Council of Bangladesh

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) Secretary, Ministry of Health, Population Control and Family Planning, ex-officio, who shall, unless the Government appoints any other officer to be the President, also be the President of the Council;

c) Director of health service, ex-officio ( ).

d) Director or head of the department of drug administration, ex-officio.

e) Chairman or head of the Department of Pharmacy in the University of Dhaka, ex-officio.

f) 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.

Md. Imran Nur Manik

Md. Imran Nur Manik



g) One qualified pharmacist to be nominated by the Bangladesh Aushad Shilpa Samity.

h) One person to be nominated by the Bangladesh Medical Association.

i) One qualified pharmacist to be nominated by the Bangladesh Chemists and Druggists Samity.

j) 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 Gazett

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.

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.

Md. Imran Nur Manik

Md. Imran Nur Manik



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.

Provided 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 Drugs Act, 1940 (XXIII of 1940), or in any Government institution or laboratory. iii. Inspectors of drugs appointed under the 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.

Md. Imran Nur Manik

Md. Imran Nur Manik



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 practices.

(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.

Health & Medicine

3206 law & ethics manik