R. B.

Rajmane,
Assistant Professor,
ASPM’s K. T. Patil College of Pharmacy, Osmanabad
Learning Outcomes
Students will be able to;
Restate its objectives

Write the constitution & functions of Pharmacy Council of India

Write the constitution & functions of state & joint state Pharmacy Council

Illustrate the qualifications of pharmacist required for first & subsequent

registers

List out the offences & penalties of the act

What is the need/purpose of this act?
Introduction & Need
 In India there was no restriction to practice the profession of
pharmacy.
 One could practice this profession as any other profession
 Persons, having no knowledge and having no education in the
pharmacy was compounding, mixing & dispensing the medicines
 As a result the wrong compounding, mixing or dispensing the
medicines were observed
 That causing the great harm to the health of people
 It was found necessary to enact a law for the regulation of the
profession and practice of pharmacy.
Introduction & Need
 As per recommendations of DEC & Health survey &
development committee, the persons should have proper
educational background to practice the profession of pharmacy

 Hence the Pharmacy Act 1948 came into force in 4th march
1948
What are the objectives?
Objective
 To regulate the profession of pharmacy
 To raise the status of Pharmacy in India
 To achive this objectives;
 The act provides the formation of (Central Council) Pharmacy
Council of India (Responsible for prescribing the minimum of
education required for qualifying as a pharmacist)
 The act also provides formation of (State Council) state Pharmacy
Council , which will be responsible for the maintenance of provincial registers of
qualified pharmacists for regulating their professional activities
Definitions
means the Pharmacy Council of India

means the register of pharmacists maintained by

the Central Council(by PCI)

means state council of Pharmacy constituted under

the act & includes the joint state pharmacy councils

means a person whose name, for the time

being, is entered in the register of pharmacists of the state in which he
is for time being residing or carrying on his profession or business of
pharmacy
Definitions

means a person holding a medical

qualification as provided in the Indian Medical Degree Act or Medical
Council Act or a person registered or eligible for registration in the
medical register of the state
What is PCI?
 Pharmacy Council of India (PCI)

The Pharmacy Council of

India is constituted by Central
government
The Pharmacy Council of
India was constituted in the
year,
Situated in
Act provide constitution under
 Pharmacy Council of India (PCI)

 The PCI composed of the following members;

I. Elected Members

II. Nominated Members

III. Ex-Officio Members – By virtue of position/status

 Pharmacy Council of India (PCI)
The PCI composed of the following members;
 Six members nominated by the Central
Six members, among whom atleast one teacher government of whom at least 4 shall be
of pharmacy, pharmaceutical chemistry, possessing degree or diploma in pharmacy &
pharmacognosy & pharmacology elected by the practising pharmacy or pharmaceutical
UGC from the teaching staff of Indian chemistry
University or an affilated a degree or diploma in  One representative each of UGC & the AlCTE
pharmacy  One member from each state, nominated by
State Government, shall be a registered
One member, elected by the Medical Council pharmacist
of India from amongst its memebers  (One member nominated by each Union
One members, elected by each State territory, who shall be registered pharmacist,
Pharmacy Council who shall be a registered under section 31 of the Pharmacy
pharmacist amendment act 1976)
Pharmacy Council of India (PCI)

(By virtue of position/status)

i) The Director General of Health Service
ii) The Director of Central Drug Laboratory
Logo of PCI
iii) The Drug Controller of India

PCI Website- http://www.pci.nic.in/

Functions of PCI
1. To the of education required for
as a
(This can be provided by making the rules called as education regulations which
prescribe, minimum qualification for admission, duration of course, details of
syllabus, practical training & examination, minimum facilities required for the conduct
of course, examination & practical training)
2. To the
For this purpose, Council appoints Inspector to inspect the institutions providing the
minimum standards in education in pharmacy & report on the facilities available &
decides whether the institutes should be recognised or not.
Functions of PCI
3. To granted to which
pharmacy act 1948 extends for the purpose of qualifying for
registration under the said Act

4. To compile & maintain a containing

names of all persons for the time being entered in the state register

5. that may be in
the furtherance of the objectives of the pharmacy act, 1948
 Terms of Office & Casual Vacancies
President & Vice President of Central Council
The president & vice president of the council shall be elected by the members of
the council amongst themselves & holds a office for a term not exceeding 5
years & not extending beyond the expiry of his term, as a member
Nominated & elected members shall hold office for a term of 5 years from the
date of nomination or election & the members may resign his membership at any
time by writing to the president or the members should have to vacate his seat if
he/she is absent for three consecutive meetings of the council

Causal vacancies as in above cases can be filled by fresh nomination or

election

Members of central council can be eligible for re-nomination or re-election

Executive Committee
The Pharmacy Act provides constitution of Executive committee by
the Central Council:
Executive committee consist of the
1. Ex. Officio members:
a) President who shall be the chairman of this committee; &
b) Vice president; &
2.Five other members elected by the Central Council from
amongst its members

A members of the EC shall hold office as such until the expiry of his
term of office as member of the Central Council
What is Education Regulation?
Education Regulation
As per provision of section 10 of the Pharmacy Act 1948, Central
Council after approval of the Central Government may make regulations to
be called as Education Regulations, which prescribe the minimum
standard of education required for qualification as pharmacist

The education regulation may prescribe;

1) Minimum qualification for admission to the course

2) The nature & period of course of study & practical training to be
undertaken after the completion of the regular course
3) The subject of examination & the standard attained therein
4) The equipment & facilities to be provided by the institution for the students
5) To prescribe conditions to be fulfilled by institutions giving practical
training & authorities holding approved examinations
 Implementation of ER
Central Council before submitting ER for approval to Central
Government,
Send copies of draft of ER & all subsequent amendments to all state
Governments
And take into consideration the comments of any state government
received within three months
Then ER is published in Official Gazette by central government as
directed central council
 After notification in the Official Gazette ER shall take effect in the state
Eg. Pharm. D. Regulations 2008
State Pharmacy Council
For example; Maharashtra State Pharmacy Council, Mumbai

 As per Chapter 3 of Pharmacy Act 1948

 Every State has to form their State Pharmacy Council
 Or
 Two or more state may have their Joint state
Pharmacy Council
(When 2 or more state enters into agreement, whereby state
Pharmacy Council of one state serves the need of other
state)
 State Pharmacy Council & Joint State PC
State Pharmacy Council Joint State Pharmacy Council
(i) Elected Members- Six members, elected (i) Elected Members- NLT 3 & NMT 5
from amongst themselves by registered members elected from amongst the registered
pharmacists of state pharmacists of each participating State
(ii)one member, elected by the members of (ii)One member, elected from amongst
Medical Council of State amongst themselves by the members of each Medical
themselves Council of State amongst themselves each
(iii)Nominated Members- Five members, participating State
nominated by State Government of (iii)Nominated Members- NLT 2 & NMT 4
whom at least 3 shall be person nominated by each participating state of
possessing a prescribed degree or whom more then half should possesses
diploma in pharmacy or pharmaceutical degree or diploma in pharmacy or
chemistry or registered pharmacist pharmaceutical chemistry or be a registered
pharmacist
 State Pharmacy Council

State Pharmacy Council Joint State Pharmacy Council

Ex-Officio Members- Ex-Officio Members-
(i)Chief administrative medical officer (i)Chief administrative medical officer
of the State of each participating State
(ii)Officer-in-charge of drugs control (ii)Officer-in-charge of drugs control
organization of the State organization of each participating
(iii)Government Analyst appointed State
under DC Act 1940 0f the state (iii) Government Analyst appointed
under DC Act 1940 0f each
participating state
 Terms of Office & Casual Vacancies
President & Vice President of State Council
The president & vice president of the state council shall be elected by the members of
the state council amongst themselves & holds a office for a term not exceeding 5
years & not extending beyond the expiry of his term, as a member

Nominated & elected members shall hold office for a term of 5 years from the date
of nomination or election & the members may resign his membership at any time by
writing to the president or the members should have to vacate his seat if he/she is
absent for three consecutive meetings of the state council

Causal vacancies as in above cases can be filled by fresh nomination or election

Members of state council can be eligible for re-nomination or re-election

 Staff, Remuneration & Allowance
 With previous sanction of State govt. State Council may appoint;
o Registrar, who also act as a secretory & treasurer of the state council for a period of 4
years
o Appoint such other officers & servants as may be required to carryout its functions
o Fix the salaries & allowances of service of secretory & other officers & servants

 Executive committee
Executive committee consist of the
1. Ex. Officio members:
a) President who shall be the chairman of this committee; &
b) Vice president; &
2.Five other members elected by the Central Council from amongst its members
A members of the EC shall hold office as such until the expiry of his term of office as member of
the Central Council
Functions of State Pharmacy Council
1. Inspection by State council

2. Maintenance of Registers

3. Entry & removal of names

4. Printing of Registers

5. Restoration of the name to Register

6. Issue of duplicate certificate of registration

 Functions of State Pharmacy Council
1. Inspection by State council:
The state council appoints suitable numbers of inspectors
to,
Inspect premises where drugs are compounded or
dispensed
Inquire regarding the registration of a person
Investigate complaints
Institute Prosecution
Registration of Pharmacists
 State Council prepare & maintain the register
 The register shall include;
 Full name & residential address of registered person
 Date of his first entry in register
 Qualification
 Professional address (& if he is employed by any person, the name
of such person)
 Preparation of First register
 State govt. (by notification in Official Gazette) constitute a Registration Tribunal
 Registration Tribunal consist of three persons & a Registrar (who act as secretory)
 State govt. give a Date of Application
 (State govt. then by notification, specify a date on or before which, application along
with prescribed fees made to Registration Tribunal)
 Registration Tribunal examine every application
 If satisfied, Name of Applicant is registered in Register
 The first registered so prepared is published (appeal within 60 days)
 The registrar issues certificate of registration (Whose name is entered in register)
 After formation of state council, state govt. hand over this register & application fees
to state council
 Qualification for Entry on First register
 A person having age of 18 years, paid fees should have the following qualification;
 A degree or diploma in pharmacy, or pharmaceutical chemistry or a chemist & druggist
of an Indian University, or a state govt. or a prescribed qualification granted by an
authority outside India,
 A degree of an Indian University other than a degree in pharmacy & has been engaged
in compounding of drug in hospital or dispensary or other in which drugs are regularly
dispensed on prescription of Medical Practitioners for total period of NLT 3 years
 Has passed an exam recognized as adequate by the state govt. for compounders or
dispensers
 Has NLT 5 years experience of compounding & dispensing of drugs prior to the date
notified by registration tribunal for receipt of the application for entry of the name on first
register
Removal of Names
 A person whose name has been removed from the register of any state shall
not be entitled to registration unless the state council gives its consent
 The name of a pharmacist may be removed from the register in following
cases-
 If his name is entered in the register by error
 If he been has convicted of an offense in any professional respect
 If a person employed by him is convicted of an offense or is guilty of infamous
conduct
 30 Day of period for appealing
 Surrender of the certificate of registration & published in the official gazette
Offences & Penalties
Offences Penalties
1. Falsely claims to be a Registered Fines up to Rs 500 on first conviction
Pharmacist Fines up to Rs 1000 & / 6 month
imprisonment of any subsequent
conviction
2. Dispensing by a Unregistered 6 month imprisonment or a fines up
person to Rs 1000 or both
3. Failure to surrender the Fines up to Rs 50
Certificate of Registration
4. Obstruction of State Pharmacy Imprisonment up to 6 month Or a
Council Inspector fines up to Rs 1000 or both
References

1. Forensic Pharmacy by Dr. BS Kuchekar & Sachin Itkar.

2. A textbook of Forensic Pharmacy- BM Methal.
3. A textbook of Forensic Pharmacy- NK Jain.
4. A textbook of Pharmaceutical Jurisprudence & ethics by Dr. SP
Agrawal & Dr. Rajesh Khanna.
5. A textbook of Pharmaceutical Jurisprudence & ethics by K Sampath.