Ph'Jurisprudence
Ph'Jurisprudence
Ph'Jurisprudence
A)Advisory bodies
I) Drug TechnicalAdvisory Board (DTAB) [sec. 5]
Drugs Technical Advisory Board is constituted by Central Government and its function
is to advise the Central Government and State Government on the technical matters arising out of
the administration of thisAct.
It is reconstituted after every 5 years. It has following members
A. Ex-officio Members
1. Director General of Health Services who shall be Chairman of the Board.
2. Drugs Controller of India.
3. Director of Central Drugs Laboratory, Calcutta.
4. Director of Central Research Institute, Kasauli.
5. Director of Indian Veterinary Research Institute, Izatnagar.
6. Director, Central Drugs Research Institute, Lucknow.
7. The President, Pharmacy Council of India.
8. The President, Medical Council of India.
B. Nominated Members:
1. One person is nominated by the Central Government from the Pharmaceutical
Industry.
2. Two persons are nominated by the Central Government from amongst the persons
who are in charge of the Drugs Control in the States.
3. Two Government Analysts are nominated by the Central Government.
C. Elected Members:
1. One person is elected by the Executive Committee of Pharmacy Council of India from
amongst teachers in pharmacy, pharmaceutical chemistry or pharmacognosy on the
staff of an Indian University or Colleges affiliated there to.
2. One person is elected by the Executive Committee of the Medical Council of India
from amongst the teacher in medicine or therapeutics on the staff of a University or
Colleges affiliated there to.
Drugs & Cosmetics Act, 1940 & Rules, 1945 | 33
B)Analytical bodies
1) Central Drugs Laboratory (CDL)[sec.6]
Central Drugs Laboratory is established by the Central Government under the control of
Director.
Functions of CDL
1. To analyse or test the samples of drugs or cosmetics as may be sent to it by-
a) Customs collectors; or
b) any other authorized officer.
2. To carry out such other duties as may be entrusted to it by Central Government or by
State Government with the prior sanction of Central Government after consultation with
DTAB.
3.a)In case of sera, vaccines, toxins, antigens, antisera, solution of serum proteins for
injections, sterilized ligature and suture and bacteriophages, the functions of CDL is
carried out at the Central Research Institute, Kasauli and such functions are exercised by
the Director of the said institute.
The functions regarding Oral Polio Vaccine are exercised by the Deputy Director and
Head of the Polio Vaccine Testing Laboratory of Central Research Institute, Kasauli.
b) In case of antisera, vaccines, diagnostic antigens and toxoids for veterinary use, the
functions of CDL are carried out at the Indian Veterinary Research Institute, Izatnagar or
Mukteshwar and such function are exercised by the Director of the said institution.
c) In case of condoms, the functions of CDL are carried out at Central Indian
Pharmacopoeia Laboratory, Ghaziabad and such functions are exercised by Director of
the said laboratory.
d) In case of Veneral Disease Reference Laboratory (VDRL) antigens the function of CDL
34 | Textbook of Pharmaceutical Jurisprudence
3. GovernmentAnalyst
Government Analyst is a person appointed by Central Government or State Government
under section 20. A person to be appointed as Government Analyst should have no financial
interest.
Qualifications
A person to be appointed as Government Analyst should possess the following
qualifications.
1. Graduate in medicine or science or pharmacy or pharmaceutical chemistry of a
recognized University with not less than 5 years post Graduate experience ;or
Drugs & Cosmetics Act, 1940 & Rules, 1945 | 35
C) Executive bodies
1. Drug Inspector
Drug Inspector is appointed by Central Government or State Government under section
21. He should have no financial interest in import, manufacture, distribution or sale of the drug or
cosmetic.
Qualification
A person to be appointed as drug inspector should be graduate in pharmacy or
pharmaceutical chemistry or medicine with specialization in Clinical Pharmacology or
Microbiology from recognized University established in India.
Provided that-
1. a person who has not less than 18 months experience in the manufacture of at least one
of the substances specified in Schedule C; or
2. who has not less than 18 months experience in testing of at least one of the substances
specified in schedule C; or
3. who has not less than 3 years experience in inspection of firms manufacturing at least
one of the substances specified in Schedule C.
Learning objectives
When you have finished this chapter you should be able to:
1. define ethics and differentiate it with law.
2. know the relationship of pharmacist in respect to his job and trade.
3. know the relationship of pharmacist with physician and with professional colleagues.
Introduction
Ethics is a science which deals with the study of moral duties and is concerned with
human conduct and character. It is a right or wrong human behaviour. A code of ethics is a
carefully formulated set of principles for the guidance of the particular group or members of the
profession.
Ethics is different from law in many respects. It can be differentiated from the law as
given below:
Law Ethics
It is an authorative instrument that rules It is a way of conducting life laid down by
over the society. the society to help the individuals to decide
what is right and wrong.
Law can prevent the illegal practice of It can prevent unethical practices of
pharmacy. pharmacy that can cause grave risk or danger
to the life of individual or patient.
Law can prevent the sale of substandard The sale of substandard quality drugs and at
quality drugs but cannot prevent selling of cheaper rate is restricted by the code of
drug at cheaper rate. ethics.
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Code of Pharmaceutical Ethics | 19
Summary
Every country has its own national and state laws. Every person including pharmacist
should be aware of it and he should obey the laws. Pharmacist being a part of healthcare system
should have the knowledge of laws related to drugs. He should maintain the relationship with
patients, his colleagues and other members of healthcare system. He should do his duties
honestly without any error. He should try to improve the status of pharmacy profession with his
social activities.
Acode of pharmaceutical ethics is divided into the following parts:
1. Pharmacist in relation to his job
2. Pharmacist in relation to his trade
3. Pharmacist in relation to medical profession
4. Pharmacist in relation to his profession
4. If there is any error in the prescription which one of the following statement will be correct?
a. Pharmacist should correct it himself
b. Pharmacist should ask to trainee pharmacist
c. Pharmacist should take a help of patient
d. Pharmacist should ask to doctor
5. If pharmacist is making an attempt to capture the business of fellow pharmacist it is_____.
a. cut throat competition b. professional vigillance
c. interstate agreement d. none
6. Pharmacist should not interfere the duties of physician, he should carry out his own duties that
is _______.
a. diagnosis b. prescribing remedies
c. compounding and dispensing of drugs d. None
7. If pharmacist has made secret contract with doctor it is called as ________.
a. cut throat competition b. clandestine arrangement
c. interpersonal agreement d. none
Important questions
1. Define ethics. How does it differ from laws?
2. Name the various parts of code of pharmaceutical ethics.
3. How should be the relationship of pharmacist with physician?
4. Write a note on – Pharmacist in relation to his trade.
5. How the pharmacist should supply the medicine in a hospital?
6. How pharmacist should handle the prescription?
7. What is the meaning of clandestine arrangement?
8. Write a note on – Pharmacist in relation to his profession.
9. Describe in brief Pharmacist in relation to his job.