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Chapter II Administrative Bodies

There are three administrative bodies which are as follows-
1. Advisory bodies Drug Technical Advisory Board and Drugs Consultative
Committee
2. Analytical bodies Central Drugs Laboratory, Drugs Control Laboratories in
States and Government Analyst
3. Executive bodies Controlling authorities, Licensing authority, Drug Inspector

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

3. One Pharmacologist is elected by the Governing Body of the Indian Council of

Medical Research.
4. One Person is elected by the Central Council of Indian MedicalAssociation.
5. One Person is elected by the Council of the Indian PharmaceuticalAssociation.

II) Drug Consultative Committee (DCC)

It is constituted by the Central Government and its function is to advise the Central
Government, or State Government and DTAB on any matter tending to secure uniformity
throughout India in the administration of thisAct.
Constitution
1. Two persons are nominated by the Central Government.
2. One person from each State is nominated by that concerned State Government.

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
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is carried out at the Laboratory of Serologist and Chemical Examiner to Government of

India and such functions are exercised by Serologist and Chemical Examiner of the said
laboratory.
e) In case of IUCD (Intrauterine Contraceptive Devices) and felope rings, the functions of
CDL are carried out at Indian Institute of Technology, New Delhi and such functions are
exercised by Head of said department.
Dispatch of samples for test or analysis
Samples for the test or analysis are to be sent by the registered post in a sealed packet
enclosed with a memorandum in Form 1 accompanied with prescribed fee to the Director.
A copy of memorandum and specimen impression of the seal used to seal the packets are
sent separately by registered post.
On receipt of the sample, the authorized officer on behalf of the Director opens the
packet and records the conditions of the seal. After test or analysis the report of analysis is
supplied in the Form 2 together with full protocols of the tests applied. The report of analysis is
signed by the Director of the Central Drugs Laboratory.

2. Drugs Control Laboratories in the States [sec.7]

Every State shall establish Drugs Control Laboratories to analyse or test the samples of
drug from the licensed, manufacturing premises in their respective areas.
Sample of drugs taken by the Drug Inspectors from the manufacturing premises or retail
shops is analyzed in these laboratories.
These laboratories also undertake the testing or analysis of drug on the behalf of the
manufacturers who do not have their own facilities for testing or analysis of samples of drugs on
the payment of prescribed fees.
If a purchaser wants to analyse or test the samples of drugs or cosmetics he has to make
an application in Form 14A accompanying with the prescribed fees to Director and the report of
test or analysis shall be supplied in Form 14B.

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

2. Post graduate degree in medicine or science or pharmacy or pharmaceutical chemistry

of a recognized university with not less than 3 years experience.
3. Associateship Diploma of the Institution of Chemists with ‘Analysis of Drugs and
Pharmaceuticals’ as one of the subject and with not less than three years experience in
the testing of drugs in a laboratory under the control of-
a) Government Analyst; or
b) Head of an Institution of Testing laboratory approved for the purpose by the appointing
authority.
Provided that-
a. For the purpose of testing or analysis of drugs specified in schedule C, a person to be
appointed as Government Analyst should produce evidence of satisfactory training in
Physiology, Bacteriology, or Serology, or Pathology or Pharmacology or Microbiology
and should have the said experience.
b. For a period of four years from the date on which chapter IV of the Act takes effect in the
States, person whose qualification and experience are considered as adequate and
competent, such person may continue to remain in the services even after four years.
c. A person to be appointed as a Government Analyst should not be engaged directly or
indirectly in a trade or business connected with the manufacture of drugs.
d. For the purpose of examination of the veterinary biological products, person to be
appointed as Government Analyst should be graduate in Veterinary Science or General
Science or Medicine or Pharmacy with not less than five years experience in the
standardization of biological products or a person having post graduate degree in above
faculties with not less than three years said experience.
e. The person already appointed as Government Analyst may continue to remain in
service, if the appointing authority so desires even though he does not fulfill the said
qualification and experience.

Duties of Government Analyst

1. To analyse or test the samples of drugs and cosmetics sent to him by Drug Inspector or
other persons.
2. To furnish the reports of results of the test or analysis in accordance with the procedure.
3. To forward to the Government report of research or analytical work with a view to their
publication at the discretion of the Government.

Procedure to be followed by Government Analyst on receipt of Samples

1. On receipt of a package containing sample of drugs or cosmetic by Drug Inspector,
GovernmentAnalyst compares the seals on the packages with the specimen impression
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of the seal received separately.

2. He records the condition of seal on the packets.
3. After the test or analysis, he supplies reports of analysis in triplicate in Form 13
together with full protocols of test applied.
Report of Government Analyst
The report of Government Analyst is held to be conclusive only if it is not challenged
according to the procedure given within 28 days of receipt of copy of the report by the person
from whom sample was taken.

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.

Powers of Drug Inspector

Within the local limits for which the drug Inspector is appointed may
1. Inspect
a. any premises wherein any drug or cosmetic is being manufactured and the means
employed for testing and standardizing the drug or cosmetic.
b. any premises wherein any drug or cosmetic is being sold, stocked or offered for sale or
is being distributed.
2. Takes samples of any drug or cosmetic
a. From premises wherein any drug or cosmetic is being manufactured or sold or offered
for sale or is being distributed.
b. From any person who is in the course of conveying, preparing , delivering, preparing to
 Drugs & Cosmetics Act, 1940 & Rules, 1945 | 37

deliver any drug or cosmetic to a purchaser.

3. Search any person in connection with the offence under this chapter at all reasonable
time.
4. Enter and search any premises or any places in which he has reason to believe that an
offence has been committed or is being committed.
5. Stop and search any vehicle or vessel or any other conveyance which is used for carrying
any drug or cosmetic in respect of which offence has been committed or is being
committed.
6. Give order (in writing) in possession of drug or cosmetic in respect of which the offence
has been committed or is being committed; not to dispose stock of any drug or cosmetic
for a specified period not exceeding 20 days or unless the defects may be removed by the
possessor of the drug or cosmetic, if necessary he may seize it .
7. Examine any register or any record of drug or cosmetic which is in contravention of the
provisions of thisAct.
8. Exercise the powers of Drug Inspectors for carrying out the purpose of thisAct.

Duties of Drug Inspectors

Duties in relation to sale of drug
1. To inspect at least twice a year, all the premises licensed for sale of drugs and cosmetics.
2. To check whether the conditions of the licenses are being observed or not.
3. If he thinks necessary, to obtain and send the samples of drugs and cosmetic for test or
analysis.
4. To investigate any complaint made to him in writing.
5. To institute prosecutions in respect of breach of theAct.
6. To maintain records and actions taken by him and to submit the copies of such records to
controlling authority.
7. To make inquires and inspections regarding sale of drug, the sale of which is for time
being restricted.
8. To detain the imported packages, if import of such drug or cosmetic is for the time being
prohibited.

Duties in relation to manufacture of drug

1. To inspect at least twice a year, all premises licensed for the manufacture of drugs and
cosmetic.
2. To check whether the conditions of licenses are being observed or not.
3. For the manufacture of drugs specified in schedule C and C(i) to inspect-
a. Plant and process of the manufacture.
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b.The means employed for testing and standardizing of drugs.

c.Method and place of storage.
d.Qualifications of the technical staff employed.
e.The location, construction and administration of the establishment which may affect
purity and potency of drugs.
4. To take the sample of drugs from the manufacturing premises and send them for test or
analysis.
5. To institute prosecutions in respect of the breach of theAct.

Procedure of Inspection (to be followed by Drug Inspector)

1. Where an Inspector takes the sample of drugs, he shall pay the fair price of it and may
give written acknowledgment there of.
2. Where a price is refused or where an Inspector seizes the stock of drugs, he shall give
receipt of it in Form 16.
3. Where an Inspector takes the sample of drug for test or analysis he shall intimate such
purpose in Form 17 in writing to a person from whom he takes it.
4. In presence of such person, unless he wilfully absents himself, the drug inspector shall
divide the sample into four portions, effectively seal and mark them and allow that
person to add his own seal and mark.
5. Where an Inspector takes the sample of drug or cosmetic from manufacturing premises
sample should be divided into three portions only.
6. Where a drug or cosmetic is made up in small volume containers and if drug is likely to
deteriorate or damage by exposure, drug inspector shall take three or more containers
after suitably marking the same and sealing them.
7. Drug inspector shall give one portion of sample to a person from whom he takes it and
divide the remaining three portions as follows:
a. He shall sent second portion to the Government Analyst for test or analysis.
b. He shall produce third portion in the court before which proceedings have been
instituted.
c. He shall send fourth portion to warrantor whose name, address and other particulars
have been disclosed.
8. The portion of sample or container shall be sent by registered post or by hand. A copy of
memorandum and specimen impression of seal used to seal the packets shall be sent
separately by registered post.
9. When an Inspector seizes the register, records or other document and samples of drugs
or cosmetics he shall inform Judicial Magistrate and take his order of custody.
 Chapter 3
CODE OF PHARMACEUTICAL ETHICS

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.

Pharmaceutical Code of Ethics

Code of pharmaceutical ethics is framed by Pharmacy Council of India for the
pharmacists in India. It guides to the pharmacist regarding how to behave in the society i.e. with
patient, public and his colleagues.
The pharmacist is a vital link between the doctor and the patient. He is responsible to
provide professional services of high order to the community at large by ensuring production of
quality medicines and its sale, distribution to the consumers thereby safeguarding the health of
the public. Acode of pharmaceutical ethics is divided into the following parts:
1. Pharmacist in relation to his job

18 |
 Code of Pharmaceutical Ethics | 19

2. Pharmacist in relation to his trade

3. Pharmacist in relation to medical profession
4. Pharmacist in relation to his profession

1. Pharmacist in relation to his job

a) Scope of Pharmaceutical Services
Pharmacist who is engaged in hospital pharmacy should supply the medicines correctly
and properly. He should supply the medicine efficiently without delay. More care should be taken
during emergency supplies.
b) Conduct of Pharmacy
In a pharmacy section of hospital pharmacy, pharmacist prepares the medicine
according to the prescription of physician. During compounding he should not make any errors
as the medicines if dispensed wrongly may not give the necessary relief to the patient from
disease. On the contrary, there may be some undesirable side effects.
c) Handling of prescription
As the prescriptions given by physicians are presented to pharmacists for dispensing,
pharmacist is supposed to maintain its secrecy and should not make any comment on it. He
should read it carefully and then decide what type of medication is required to prepare. No any
addition, omission, or substitution of ingredients should be made without the consent of the
prescriber. If there are some errors in doses he should not correct it himself, he should consult to
physician.
d) Handling of drugs
In hospital pharmacy, the varieties of drugs are available and the chief pharmacist is
responsible for handling of drugs. During compounding and dispensing, he should use standard
quality drugs and weigh it accurately. He should take more care during handling of poisonous
substances.
e)Apprentice pharmacist
Every pharmacist has to undergo the practical training after completion of the academic
training. Chief pharmacist should provide uniform practical training to all the new pharmacists.

2. Pharmacist in relation to his trade

a) Pricing of drugs
Pricing of drugs and pharmaceuticals should be fair. The overcharging of the products
should be avoided. A suitable price structure should be adopted for pricing of drugs. He should
calculate the retail price of his formulation according to the formula prescribed under Drugs and
Price Control Order. While calculating the price he should consider the material cost, packaging
charges, cost of packaging material, etc.
 20 | Textbook of Pharmaceutical Jurisprudence

b) Fair trade practice

Pharmacist should not make any attempt to capture the business of fellow pharmacist by
cutthroat competitions that is by offering gifts or reducing prices to the patient, etc. Trade marks,
signs and symbols of other pharmacist should not be copied.
c) Purchase of drugs
Pharmacist should purchase drugs of standard quality only. He should not purchase
substandard quality, adulterated drugs or misbranded drugs. He should purchase drugs under
cash or credit memo from a duly licensed manufacturers and dealers.
d) Hawking of drugs
Hawking of drugs should be prohibited under the code of pharmaceutical ethics to
prevent self medication and mismedication.
e)Advertising and display
Advertisement and display of drug should also be prohibited under the code of
pharmaceutical ethics to prevent self medication and mismedication. Advertisements of drugs
making a false claim or which gives misleading information about the drug should be prohibited.

3. Pharmacist in relation to medical profession

a) Limitation of professional activity
Pharmacist should not interfere with the duties of physician. He should carry out only his
own duties that is compounding and dispensing. Under no circumstances, he should diagnose the
patient and prescribe the remedies even though requested by the patient. In emergency, he should
provide first aid services to victim.
b) Clandestine arrangement
Pharmacist should not enter into any secret agreement or contract with physician that is
by offering commission for recommending his medical store.
c) Liaison with public
Pharmacist is a link between doctor and patient. He should have up-to-date knowledge
about the developments in pharmacy profession. For this purpose, he should be always in
constant touch with the periodicals, journals, magazines related to the pharmacy profession
which are published from time to time. He should offer advice to physician on the
pharmaceuticals. Also, he should educate the patient regarding certain techniques of
administration of drugs.

4. Pharmacist in relation to his profession

a) Law abiding citizens
Pharmacist should have the knowledge of laws related to drugs, pharmaceuticals,
chemicals, foods and cosmetics. He should obey the laws of nation and State to maintain the
 Code of Pharmaceutical Ethics | 21

standard of the profession.

b) Professional vigilance
Pharmacist should consider all other pharmacists as colleagues in pharmacy profession
and partner in health care system. All pharmacists should meet frequently on the occasion of
some conference. This is required for the welfare and cooperation to other pharmacist.
c)Association with various professional organizations
Pharmacist should associate himself with the various professional organizations, the
aims and objectives of which are compatible with code of pharmaceutical ethics.
d) Decorum and propriety
Pharmacist should not carry out such acts that will bring discredit to him as well as to the
pharmacy profession.

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

Multiple Choice Questions

1. Ethics is the study of ________.
a. fundamental legal principles b. rule of action
c. moral duties d. None
2. ______ can prevent the sale of substandard quality drugs but cannot prevent selling of drug at
cheaper rate
a. Law b. Ethics
c. Both d. None
3. The pharmacist is a vital link between _____ in health care system.
a. doctor and senior pharmacist b. doctor and manufacturer
c. doctor and patient d. all
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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.

Answers to multiple choice questions

1. c 2. a 3. c 4. d 5. a 6. c 7.b