Pharmacy Act

Download as pdf or txt
Download as pdf or txt
You are on page 1of 54

PHARMACY ACT, 1948

1
CONTENT
History of Pharmacy Act
Objectives
Definitions
The Pharmacy council of India
Provincial Pharmacy Council
Registration of Pharmacists
Renewal Fees
Removal of the names from Register
Issue of duplicate Certificates of Registration
Offences and Penalties
2
HISTORY OF PHARMACY ACT
 In India there was no restriction to practise the
profession of Pharmacy.

One could practise 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. 3
 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. 4
To achieve this goal the Pharmacy Bill, 1947 was
introduced in the Legislature which was later
referred to the Select Committee.

The recommendations of the Selection


Committee were incorporated in the Bill.

5
 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. 6
OBJECTIVES

 To restore the Pharmacy profession in its due


place in the health services.

 Raising the status of the profession of Pharmacy


in India.

 To regulate the practice of Pharmacy in India.

7
 To provide uniform education and training
through out India.

 To maintain control over persons entering the


profession of pharmacy.

 To Protect the Public Health


– Medical Use of Drugs
– Drug Abuse
8
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
9
(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; OR

10
(iv) Registered or eligible for registration in the
register of Dentists for a State under the Dentists
Act, 1948; OR

(v) Who is engaged in the practise of Veterinary


medicine and who possesses qualifications
approved by the State Government.

11
 “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.

12
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.

13
 CONSTITUTION OF P.C.I. :

 It consists of three different types of members:


A. Elected member
B. Nominated member
C. Ex-officio member

14
A. Elected members:
1) 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.
2) One member , elected by Medical Council of
India.
3) One member , elected by State Council ,who
shall be a registered Pharmacist.
15
B. Nominated members:
1) 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.
2) A Representative of the U.G.C. and a
representative of the All India Council for
Technical Education(A.I.C.T.E.).
3) One member nominated by each State
Government, who shall be a registered
pharmacist. 16
C. Ex-officio members:
1) The Director General of Health Services.
2) The Director of the Central Drugs Laboratory.
3) The Drugs Controller of India.

 Executive Committee consisting of:


 President
 Vice-president
 Five members elected by central council from
its members.
17
 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.

18
 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,
i. Minimum qualification for registration as a
Pharmacist.
ii. Minimum qualification for admission to
Diploma in Pharmacy.
19
iii. Duration of training and course of study to be
covered.
iv. Condition to be fulfilled by the academic
Institution and by the Examining Authority.
v. Nature and period of practical training .
vi. The subjects of examination and minimum
standard of passing.
vii. Condition to be fulfilled by the institution to be
recognized for giving practical training.
viii. Practical training contract form for
Pharmacists.
20
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.
21
D) Withdrawal of Approval:
If any approved course of study does not
continue up to the standards of E.R.
E) Recognition of other Qualifications:
Council recognize qualification granted by an
authority outside India , to be sufficient for
registration as a pharmacist.
F) Preparation & Maintenance of Central register of
Pharmacist containing name of all person(s).
G) Decide the mode of election.
22
PROVINCIAL PHARMACY COUNCIL
Classification:
 Provincial pharmacy council

Separate state council Inter state agreement


(S.P.C.)

Joint state- state council of-


council 1state serve the -
(J.P.C.) need of other-
state
23
CONSTITUTION OF S.P.C.
It consists of three different types of members:
A. Elected member
B. Nominated member
C. 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. 24
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. 25
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:
A. Elected member
B. Nominated member
C. Ex-officio member.
26
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.
27
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
organisation of each participating State.
 Executive Committee consisting of:
 President
 Vice-president
 The such other number of the member.
28
FUNCTIONS OF S.P.C.
i) Registration of pharmacists in the state.
ii) Preparation and maintenance of register.
iii) Fix the rates of remuneration and allowances to
its officers.
iv) Appoint inspector to,
-inspect premises where drug are dispensed,
-enquire whether dispensing is carried out by
registered pharmacist or not,
-investigate any complaint.
v) Decide mode of elections.
29
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

30
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.
31
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.

32
- 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.

33
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,
a) A degree or diploma in pharmacy OR
pharmaceutical chemistry OR
b) Chemist and Druggist diploma OR

34
c) 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.

35
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.
36
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.

37
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.

38
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.

39
1) After the preparation of First register and
before E.R. 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 atleast matriculates.

40
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.

41
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 . OR
42
 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.

43
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.
44
 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.

45
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
46
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.

47
If any person employed by the registered
pharmacist for the purposes of his business of
pharmacy.
The name of Pharmacist may be removed from
register. If,
 The person has been guilty of similar offence
during preceding 12 months and the registered
pharmacist had knowledge of such offence.
 The offence had continued over a period and the
registered pharmacist had the knowledge.
48
 If Registered pharmacist has not used his
intelligence to see the provisions of D & C Act
1940.
 His name can be removed only by the Executive
Committee of the S.P.C.
 The removal of names may either be permanent
or for specified period of time.

49
 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.

50
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.

51
OFFENCES PENALTIES
1. Falsely claiming to be a 1.(a) Fine up to Rs. 500.00 on first
registered pharmacist. conviction.
(b) Fine up to Rs. 1000.00 and/or 6
months imprisonment of any
subsequent conviction.

2. Dispensed by unregistered 2. 6 months imprisonment OR Fine


persons. up to Rs. 1000.00 OR Both.
Exception:
Medical practitioners.
3.Failure to surrender certificate of 3. Fine up to Rs. 50.00
registration.
4.Obstructing State pharmacy 4. 6 months imprisonment OR Fine
council Inspectors. up to Rs. 1000.00 OR Both.
REFERENCES
1) www.pci.nic.in/contents.htm

2) Dr.G.K.Jani , Pharmaceutical Jurisprudence,


5th edition 2005-2006,Atul prakashan,
Ahmedabad, page no 15-27.

3) http://144.16.72.182/vigyan/pharm.htm

53
54

You might also like