Pharmacy act 1948 and

new amendments
 HISTORY OF PHARMACY ACT
• 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

pharmacy or pharmaceutical chemistry or pharmacology, were
engaged in this profession.
• Hundreds of cases were found by Government wherein the
compounding, mixing, or dispensing of medicines was being
done by persons who were not adequately educated in this line.
• These causing 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
LIST OF AMENDING ACTS & ADAPTATION ORDERS.

• The Adaptation of Laws Order, 1950.

• The Adaptation of Laws (No.3) Order, 1956.
• The Pharmacy (Amendment) Act, 1959.
• The Pharmacy (Amendment) Act, 1976.
• The Pharmacy (Amendment) Act, 1982.
• The Delegated Legislation Provisions (Amendment)
Act, 1985.
 OBJECTIVES
1. To restore the Pharmacy profession in its due place in the health
services.

2. Raising the status of the profession of Pharmacy in India.

3. To regulate the practice of Pharmacy in India.

4. To provide uniform education and training through out India.

5. To maintain control over persons entering the profession of

pharmacy.

6. To Protect the Public Health – Medical Use of Drugs – Drug

Abuse
 DEFINITIONS
• “Pharmacy Act” :
An Act to regulate the profession of pharmacy.
• “Medical practitioner”
A person,
(i) Holding a qualification granted by an authority notified under
section 3 of the Indian Medical Degrees Act, 1916 or specified
in the Schedules to the Indian Medical Council Act 1956; OR
(ii) Registered or eligible for registration in a Medical register of a
State, meant for the registration of persons practicing the
Modern scientific system of medicine; OR
(iii) Registered in a medical register of a State, who, although not
falling within above first and second clause , but is declared by
a general or special order made by the State Government;
• “Registered Pharmacist" :
A person whose name is for the time being entered in the
register of the State in which he or she is for the time being
residing or carrying on his profession or business of
pharmacy.

• Central register:
Register of pharmacists maintained by Central council
 PHARMACY COUNCIL OF INDIA
• The central council (P.C.I) is constituted by the Central
government.
• First central council was constituted in 1949. It is reconstituted
every five years.
• CONSTITUTION OF P.C.I . :
• It consists of three different types of members:

1. Elected member
2. Nominated member
3. Ex-officio member
Elected members:
• Six members, elected by the University Grant
commission (U.G.C).
• There is at least one teacher of each of the
pharmaceutical chemistry, pharmacy, and
pharmacognosy and pharmacology.
• One member , elected by Medical Council of India.

• One member , elected by State Council ,who shall be a

registered Pharmacist.
Nominated members:
• Six members, nominated by the Central Government. Of
whom at least 4 shall be persons possessing a degree or
diploma in, and practicing pharmacy or pharmaceutical
chemistry.
• A Representative of the U.G.C. and a representative of
the All India Council for Technical Education(A.I.C.T.E.).
• One member nominated by each State Government, who
shall be a registered pharmacist.
Ex-officio members:
• The Director General of Health Services.
• The Director of the Central Drugs Laboratory.
• The Drugs Controller of India.

Executive Committee consisting of:

• President
• Vice-president
• Five members elected by central council from its members.
• President and Vice-President of Central Council shall be
elected by the members of the Council from themselves.

• The council shall appoint, -

• A registrar, act as secretary -Other officer and servants.
• FUNCTIONS OF P.C.I. :
A) Education Regulations (E.R.) –
• Minimum standard of education laid down by P.C.I. are known as the
“Education Regulation”.

They include,
• Minimum qualification for registration as a Pharmacist.
• Minimum qualification for admission to Diploma in Pharmacy.
• Duration of training and course of study to be covered.
• Condition to be fulfilled by the academic Institution and by the
Examining Authority.
• Nature and period of practical training .
• The subjects of examination and minimum standard of passing.
• Condition to be fulfilled by the institution to be recognized for giving
practical training.
• Practical training contract form for Pharmacist
B) To regulate the Education Regulation in the states.
C) Approval of the Institutions providing course and
examination for the pharmacists. Procedure:
i) Institution has to apply to P.C.I/A.I.C.T.E.
ii) P.C.I/A.I.C.T.E. deputes its inspector to visit the institution.
iii) Inspector then reports to council on which if council is
satisfied , it approves the course of examination.
PROVINCIAL(STATE) PHARMACY COUNCIL
• Classification
Provincial pharmacy council

Separate state council Inter state agreement

( S. P.C)

Joint state council(J.P.S.) state council of 1 state

serves need of other state
CONSTITUTION OF S.P.C.

It consists of three different types of members:

• Elected member

• Nominated member

• Ex-officio member.

A . Elected member:

1) six members, elected from amongst themselves by registered

pharmacists of the State;

2) one member elected from amongst themselves by the

members of each Medical Council of the state.
B . Nominated member
1) Five members, of whom at least three shall be possessing a
degree or diploma in pharmacy or pharmaceutical chemistry
or be Registered Pharmacists, nominated by the State
Government.
C. Ex-officio member
1) Chief administrative medical officer of the State.
2) Government analyst nominated by State government under
the D & C act 1940.
3) Officer in charge of drugs control organisation of the State.
JOINT STATE PHARMACY COUNCIL
• Two or more State Governments can agree that the State
Council of one State is to serve the needs of the
participating States.
• Composition of Joint State Councils:

It consists of three different types of members:

1. Elected member

2. Nominated member

3. Ex-officio member.
A. Elected member :

1) 3-5 members elected amongst themselves by the Registered

Pharmacists of each of the participating States.

2) One member elected from amongst themselves by the members

of each Medical Council of each State.

B . Nominated member:

1) 2-4 members nominated by each participating state, of whom

more than half possess a degree or diploma in pharmacy or be
Registered Pharmacist.
C. Ex-officio member:
1) The Chief administrative medical officer of each
participating State.
2) The Government Analyst of each participating state.
3) The officer in-charge of drugs control organization of each
participating State.
Executive Committee consisting of:
President
Vice-president
The such other number of the member.
• REGISTRATION OF PHARMACISTS
• The Pharmacy Act,1948, provides for the registration
of pharmacists .
• There are two types of register,
• 1)First register
• 2)Subsequent register
• The Preparation and maintenance of Register:

The Register shall include the following particulars, namely:

a) The full name and residential address of the registered

person;

b) The date of his first admission to the register;

c) His qualifications for registration;

d) His professional address, and if he is employed by any

person, the name of such person;

e) Such further particulars as may be prescribed.

PREPARATION OF FIRST REGISTER
For the preparation of the first register, the State Government has
to constitute a Registration Tribunal
 The Tribunal consisting of : -

Three persons, A Registrar -act as Secretary.

• Tribunal fixes the date on or before which all applications for
registration with prescribed fees are accepted.
• All applications are examined.
• If tribunal is satisfied, it directs the entry of the name of the
applicant on the register.
QUALIFICATIONS FOR ENTRY ON FIRST REGISTER
• Applicant should be at least 18 years old.

• Applicant should reside or carries on the business or profession

of pharmacy in the concerned State.
• Applicant should hold,

1. A degree or diploma in pharmacy OR

2. pharmaceutical chemistry OR
3. Chemist and Druggist diploma OR
4. Qualification granted by authority outside India which is
adequate for registration.
OR
d) Degree of an Indian universities with not less than 3
years experience in dispensing in hospital.
OR
e) Passed an examination for dispensers recognized by
state government .
OR
f) Not less than 5 years experience of compounding prior
to the date notified by Tribunal.
SUBSEQUENT REGISTERS:

Procedure for subsequent registration:

From the registered pharmacists of the first register constitution of State council take

place

Application are invited within fix date , addressed to the registrar

If registrar found that applicant has requisite qualification, he may direct his/her name to

be entered in register.

If application has been rejected by registrar , he/she may appeal to state council

within 3 months of the rejection.

The decision of the state council shall be final.
REQUIREMENTS FOR SUBSEQUENT REGISTRATION

Applicants should be at least 18 years of the age. Applicants should

carry on the profession of the pharmacy in the concerned state.

QUALIFICATIONS FOR SUBSEQUENT REGISTRATION:

There are 3 different types of qualifications prescribed

1) After the preparation of first register and before E.R. take effect.

2) After E.R. take effect.

3) Special provisions.
1. After the preparation of First register and before Educational
Regulation. take effect
a) Satisfies the conditions prescribed by the Central Council OR
b) A registered pharmacist in another State. OR
c) Possesses a qualification for registration granted outside the states and are
at least matriculates.

2) After the Education regulations take effect:

Those who have passed an approved examination OR
Those who possesses a qualification granted by authority outside India and
recognize by the P.C.I. OR
Those who are Registered Pharmacist in another State.
3) Special provisions:
• Provision made under The Pharmacy Act 1959, apply to
persons;
 Affected by the partition in 1947
 Due to reorganization of the state in 1956
 Migrated to India

• Provision made under The Pharmacy Act 1976;

 Those who possess degree or diploma in pharmacy or
Pharmaceutical chemistry.
 OR Chemist & druggist diploma of Indian university.
 Passed an examination recognized for dispenser by State
government . OR
 Person approved as “Qualified persons” before 31st December
1969 under D & C Act.
 Any displaced persons from Bangladesh , Burma ,Uganda , Sri
Lanka, were carrying profession of pharmacy for period of 5
years prior to date of application.
 RENEWAL FEES
 Retention of a name on the register , subject to the
payment of prescribed fee annually before the 1st day of
April.
 If a renewal fee is not paid by the due date, the Registrar
shall remove the name of the defaulter from the register.
 Provided that a name so removed may be restored to the
register on such conditions as may be prescribed.
 On payment of the renewal fee, the Registrar shall issue
a receipt therefore and such receipt shall be proof of
renewal of registration.

 Entry of additional qualifications obtained by registered

pharmacist shall be entered in the register on payment
of prescribed fees
 REMOVAL OF NAME FROM REGISTER
The name of Pharmacist may be removed from register,
i) If his name has been entered into the register by error. OR
ii) If he has been convicted of any offence in any professional respect
which renders him unfit to be kept in the register. OR
iii) If the employed person is registered pharmacist , his name may be
removed from register .
 If, Convicted of offence or held guilty of infamous conduct.

 Offence was investigated by registered pharmacist himself.

 If the repetition of similar offence or conduct during the period of 12

month
• Pharmacist may go to the appeal to the State Government
within 30 days.
• A person whose name has been removed from the register
is required to surrender his certificate or registration to the
Registrar.

Issue of duplicate certificates of registration: Where it is

shown to the satisfaction of the Registrar that a certificate
of registration has been lost or destroyed, the Registrar
may, on payment of the prescribed fee , issue a duplicate
certificate in the prescribed form.
 OFFENCES PENALTIES

OFFENCES PENALTIES
1.Falsely claiming to be a registered 1. (a) Fine up to Rs. 500.00 on first
pharmacist conviction.
(b) Fine up to Rs. 1000.00 and/or 6
months imprisonment of any
subsequent conviction.

Dispensed by unregistered persons. 6 months imprisonment

Exception: OR
Medical practitioners. Fine up to Rs. 1000.00 OR Both.

3.Failure to surrender certificate of Fine up to Rs. 50.00

registration.

4.Obstructing State pharmacy council 6 months imprisonment

Inspectors. OR
Fine up to Rs. 1000.00 OR Both.
Thank You