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PHARMACY ACT, 1948
PREPARED BY: SHEELA. S. THORAT
M. PHARM( PHARMACEUTICAL CHEMISTRY)
ANNASAHEBDANGE COLLEGE OFB.PHARMACY,(D.PHARM)ASHTA
ASSISTANT PROFESSOR
Subject:pharmaceutical jurisprudence
1
CONTENTS:
 Introduction&
History
 Objective
 Definitions
 PCI
 E.R.
2
CONTINUED …..
Pharm D. Regulation 2008
Approval and Withdrawal of Institution
State Pharmacy Council
Qualification granted Outside the
territories
Registration of Pharmacist
3
INTRODUCTION & HISTORY
 Pharmacy Act was implemented in March 1948.
 History
4
Great harm
to the health
of people
Early 20th century-
No restriction to the
practice of pharmacy
Poor quality
of service
Absence of
recognized
curriculum
OBJECTIVE
Regulating and raising the Status of Profession of
Pharmacy in India
Providing uniform education and training to the
person willing to enter the Profession of Pharmacy
Maintaining control over the persons entering the
Profession Pharmacy
5
DEFINITIONS
 Central Council
 Central Register
 Medical Practitioner
a) A person holding a qualification granted by an
authority specified and notified under section 3 of
Indian Medical Degree Act, 1916 or specified in
schedule of IMC Act, 1956 OR 6
CONTINUED……
 Registered Pharmacist
A person whose name for time being entered in
the register of the Pharmacist of the state, in which
he is for time being residing and carrying on his
profession.
7
CONTINUED…..
 Displaced Person
a) A person who on account of the setting up of the
Dominions of India and Pakistan or on account of
civil disturbances or fear of such disturbances in
the area now forming a part of Pakistan has on or
after first day of March 1947, left or been
displaced from his place of residence in such area
and who has since then residing in India 8
 After 14 th day of April 1957 before, March 1971
 Repatriate
Any person of Indian origin who account of civil
disturbances in any area now forming a part of Burma,
Shrilanka, Uganda, or any other country has after 14 th
day of April 1957, left or has been displaced from
place of residence or who has since residing in India
 University Grant Commission 9
THE PHARMACY COUNCIL OF INDIA
 The PCI was first constituted in the year 1949.
Reconstituted for every 5 years.
Constitution
 A. Elected members
 B. Nominated members
 C. Ex-officio members
10
11
Elected Members
• Six Members –
Selected by
UGC among
them at least
one from
teaching
profession.
• One member
elected by MCI
• One member
elected by State
Pharmacy
Council.
Nominated
Members
• Six Members –
nominated by
central
government
• One
representative
each –UGC and
AICTE
• One registered
Pharmacist
nominated by
state
government
Ex-Officio Members
• Director General
of Health
Services
• Drug Controller of
India
• Director of
Central Drug
Laboratory
FUNCTIONS OF PCI
 To Prescribe the minimum standards of
education required for qualification of
Pharmacist.
 To regulate the minimum educational
standards
 To Compile and Maintain the Central
register
 Any other function
12
CONTINUED……
 President and Vice President
 The executive committee consists of
1. President
2. Vice president
3. Five members elected by Central Council
from its member’s
 Apart from this, the council also appoints
 1. A registrar
 2. Other officers and servants for carrying
out its statutory functions. 13
EDUCATION REGULATIONS
1. Minimum qualification for admission in to the course.
2. Duration of training and course of study to be covered.
3. Equipment's and facilities to be provided by the institutions.
4. Giving practical training.
5. Holding approved examinations.
 The Educational Regulations shall be published in the
Official Gazette and in such other manner as the Central
Council may direct.
14
PHARM.D.REGULATION 2008
 Purpose
 Types of Pharm.D. Programme
1. Pharm D.
2. Pharm.D. (Post Baccalaureate)
 Duration Of the Course
 Phase-I : 1-5 th yr. Course study
15
CONTINUED……
 Phase-II: One yr. Internship
2) Pharm.D. (Post Baccalaureate)
 Phase-I : 1-2 yr Course study
 Phase-II : One Yr. internship
 Qualification for Admission
 Reservation
 Number of Seats and Examination
 Permission
16
APPROVAL &WITHDRAWL OF
INSTITUTION
 Application by the Institution and Authority to the
Central Council
 Inspection
 Approval
 Declaration
Withdrawal of Institution
Executive Committee – Central Council – Notice to the
Concern Institution – Representation from Institution
17
CONTINUED….
 Qualification Granted Outside the territories to
which Pharmacy Act, Extends
 Central Register of Pharmacist
 State Pharmacy Council and Joint State Pharmacy
Council
18
STATE PHARMACY COUCIL &JSPC
19
Elected Members
 Six Members elected
amongst themselves by
Registered Pharmacist of
State
 One member elected by the
member of Medical Council
of state amongst themselves
Elected Members
 As Provided in the
agreement NLT 3 and NMR
5 Members
 One member elected by the
member of each medical
Council
State Pharmacy Council
Joint State Pharmacy
Council
CONTINUED….
20
Nominated Member
 Five Members nominated
by state government out of
three shall be possessing
degree
Ex-officio Members
o Chief Administrative
Medical Officer of the state
Nominated Member
 NLT 2 and NMT 4 members
nominated by each
participating state government
of whom more than half shall
be possessing degree
Ex-officio Members
o Chief administrative Medical
Officer
Continued… Continued…..
CONTINUED……..
21
 Officer Incharge of Drug
Control Organization of the
state
 Government analyst
 Officer Incharge of Drug
Control Organization of
each Participating state
 Government analyst
Continued…. Continued…..
FUNCTIONS OF STATE PHARMACY
COUNCIL
 Registration Of Pharmacist
 Removal of name from Register
 To maintain the Subsequent register
 To Provide the 5 copies of subsequent register to
the PCI
 To submit the working report to the PCI
 To submit the 25% collected fees by the state
council to PCI
22
INSPECTOR
 The state council may appoint Inspectors having the
following Powers:
An inspector may Inspect any premises under dispensing
and submit the report to Registrar.
Enquire whether the person engaged in dispensing is a
registered pharmacist
Institute prosecution under the order of the Executive
Committee of the State Council.
23
REGISTRATION OF PHARMACIST
 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
24
PREPARATION OF FIRST REGISTER
 Constitution of Registration Tribunal
 Application to the Registration Tribunal
 Examination Of Application
 Publication of First Register
 Amendment and Issue of Certificate
25
QUALIFICATIONS FOR ENTRY IN
REGISTER
He/ She should hold a diploma in pharmacy or
pharmaceutical chemistry.
He/ She holds a degree in an Indian University other
than
 pharmacy and has been engaged in the
compounding of drugs in hospital or dispensary for a
total period not less than 3years.
 Has passed an examination recognized as adequate
26
PRINTING OF REGISTER:
 It is done on the 1stday of April subsequent to the
commencement of the Pharmacy (Amendment) Act,
1959 (24 of 1959).
 Thereafter, each year after the first of April, register
will arrange for reprinting showing supplements to
the registers.
 These supplements and registers are deemed to be
proof that the persons whose names are contained
therein, are registered pharmacists.
27
SUBSEQUENT REGISTER
 After the appointment of date to invite application
for registration, to enter the name in first register
before the effect of Education regulation
 The qualification required are
 After the effect of education regulation
 The qualification required are
28
SPECIAL PROVISION FOR REGISTRATION
OF CERTAIN PERSONS
 Pharmacy Act,(Amendment) 1959 made special
provision for registration in subsequent register
 Displaced Person and satisfaction of conditions
 Citizen of India
 Person who carry on the business of or profession
of Pharmacy in the state and who had been
satisfies all the condition for registration in first
register of state. 29
CONTINUED…..
 A person who were registered in a state existing
before 1 st November 1956 later it become a part of
another state residing and carrying on the business
in later state
 Person who reside or carry on profession in an area
in which person applies to the registration after the
commencement of Amendment Act, 1956
30
SCRUTINY OF APPLICATION FOR
REGISTRATION
ENTRY OF NAME INTO REGISTER
a. All applicants for the registration should be addressed to
the Registrar of SPC.
b. If the applicant has the requisite qualifications for
registration, he shall direct his or her name to be entered in
the register.
c. Upon entry, a certificate of registration is issued.
31
RENEWAL FEES
 The state govt. by notification in the official gazette, direct
that for the retention of the name in the register.
 In order to retain the name in the register, renewal fee shall
be paid to the state government as may be prescribed.
 Where a renewal fee is not paid by the due date, the
Registrar shall remove the name of the defaulter from the
register.
 On payment of the renewal fee, the Registrar shall [issue a
32
REMOVAL OF THE NAME FROM REGISTER
a. Registration by error.
b. If he has been convicted of any offence in any
professional aspect.
c. 30day period for appealing
d. Surrender of certificate of registration and publication in
the Official Gazette of India
33
OFFENCES AND PENALTIES
34
 PENALTIES
 Fine up to Rs.500.00 on
first conviction.
 Fine up to Rs.1000.00
and 6months
imprisonment of any
subsequent conviction
 6 months of
imprisonment or a fine
 of up to Rs1000 or both.
 OFFENCES
1. Falsely claims to be a
registered pharmacist
2. Dispensing by an
unregistered person
CONTINUED……
35
3. Failure to surrender the
certificate of registration
4. Obstruction of state
pharmacy council
inspectors
 Fine of 50 rps.
 Imprisonment of up to
6 months or fine up to
Rs1000 or both.
36

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Pharmacy act, 1948

  • 1. PHARMACY ACT, 1948 PREPARED BY: SHEELA. S. THORAT M. PHARM( PHARMACEUTICAL CHEMISTRY) ANNASAHEBDANGE COLLEGE OFB.PHARMACY,(D.PHARM)ASHTA ASSISTANT PROFESSOR Subject:pharmaceutical jurisprudence 1
  • 3. CONTINUED ….. Pharm D. Regulation 2008 Approval and Withdrawal of Institution State Pharmacy Council Qualification granted Outside the territories Registration of Pharmacist 3
  • 4. INTRODUCTION & HISTORY  Pharmacy Act was implemented in March 1948.  History 4 Great harm to the health of people Early 20th century- No restriction to the practice of pharmacy Poor quality of service Absence of recognized curriculum
  • 5. OBJECTIVE Regulating and raising the Status of Profession of Pharmacy in India Providing uniform education and training to the person willing to enter the Profession of Pharmacy Maintaining control over the persons entering the Profession Pharmacy 5
  • 6. DEFINITIONS  Central Council  Central Register  Medical Practitioner a) A person holding a qualification granted by an authority specified and notified under section 3 of Indian Medical Degree Act, 1916 or specified in schedule of IMC Act, 1956 OR 6
  • 7. CONTINUED……  Registered Pharmacist A person whose name for time being entered in the register of the Pharmacist of the state, in which he is for time being residing and carrying on his profession. 7
  • 8. CONTINUED…..  Displaced Person a) A person who on account of the setting up of the Dominions of India and Pakistan or on account of civil disturbances or fear of such disturbances in the area now forming a part of Pakistan has on or after first day of March 1947, left or been displaced from his place of residence in such area and who has since then residing in India 8
  • 9.  After 14 th day of April 1957 before, March 1971  Repatriate Any person of Indian origin who account of civil disturbances in any area now forming a part of Burma, Shrilanka, Uganda, or any other country has after 14 th day of April 1957, left or has been displaced from place of residence or who has since residing in India  University Grant Commission 9
  • 10. THE PHARMACY COUNCIL OF INDIA  The PCI was first constituted in the year 1949. Reconstituted for every 5 years. Constitution  A. Elected members  B. Nominated members  C. Ex-officio members 10
  • 11. 11 Elected Members • Six Members – Selected by UGC among them at least one from teaching profession. • One member elected by MCI • One member elected by State Pharmacy Council. Nominated Members • Six Members – nominated by central government • One representative each –UGC and AICTE • One registered Pharmacist nominated by state government Ex-Officio Members • Director General of Health Services • Drug Controller of India • Director of Central Drug Laboratory
  • 12. FUNCTIONS OF PCI  To Prescribe the minimum standards of education required for qualification of Pharmacist.  To regulate the minimum educational standards  To Compile and Maintain the Central register  Any other function 12
  • 13. CONTINUED……  President and Vice President  The executive committee consists of 1. President 2. Vice president 3. Five members elected by Central Council from its member’s  Apart from this, the council also appoints  1. A registrar  2. Other officers and servants for carrying out its statutory functions. 13
  • 14. EDUCATION REGULATIONS 1. Minimum qualification for admission in to the course. 2. Duration of training and course of study to be covered. 3. Equipment's and facilities to be provided by the institutions. 4. Giving practical training. 5. Holding approved examinations.  The Educational Regulations shall be published in the Official Gazette and in such other manner as the Central Council may direct. 14
  • 15. PHARM.D.REGULATION 2008  Purpose  Types of Pharm.D. Programme 1. Pharm D. 2. Pharm.D. (Post Baccalaureate)  Duration Of the Course  Phase-I : 1-5 th yr. Course study 15
  • 16. CONTINUED……  Phase-II: One yr. Internship 2) Pharm.D. (Post Baccalaureate)  Phase-I : 1-2 yr Course study  Phase-II : One Yr. internship  Qualification for Admission  Reservation  Number of Seats and Examination  Permission 16
  • 17. APPROVAL &WITHDRAWL OF INSTITUTION  Application by the Institution and Authority to the Central Council  Inspection  Approval  Declaration Withdrawal of Institution Executive Committee – Central Council – Notice to the Concern Institution – Representation from Institution 17
  • 18. CONTINUED….  Qualification Granted Outside the territories to which Pharmacy Act, Extends  Central Register of Pharmacist  State Pharmacy Council and Joint State Pharmacy Council 18
  • 19. STATE PHARMACY COUCIL &JSPC 19 Elected Members  Six Members elected amongst themselves by Registered Pharmacist of State  One member elected by the member of Medical Council of state amongst themselves Elected Members  As Provided in the agreement NLT 3 and NMR 5 Members  One member elected by the member of each medical Council State Pharmacy Council Joint State Pharmacy Council
  • 20. CONTINUED…. 20 Nominated Member  Five Members nominated by state government out of three shall be possessing degree Ex-officio Members o Chief Administrative Medical Officer of the state Nominated Member  NLT 2 and NMT 4 members nominated by each participating state government of whom more than half shall be possessing degree Ex-officio Members o Chief administrative Medical Officer Continued… Continued…..
  • 21. CONTINUED…….. 21  Officer Incharge of Drug Control Organization of the state  Government analyst  Officer Incharge of Drug Control Organization of each Participating state  Government analyst Continued…. Continued…..
  • 22. FUNCTIONS OF STATE PHARMACY COUNCIL  Registration Of Pharmacist  Removal of name from Register  To maintain the Subsequent register  To Provide the 5 copies of subsequent register to the PCI  To submit the working report to the PCI  To submit the 25% collected fees by the state council to PCI 22
  • 23. INSPECTOR  The state council may appoint Inspectors having the following Powers: An inspector may Inspect any premises under dispensing and submit the report to Registrar. Enquire whether the person engaged in dispensing is a registered pharmacist Institute prosecution under the order of the Executive Committee of the State Council. 23
  • 24. REGISTRATION OF PHARMACIST  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 24
  • 25. PREPARATION OF FIRST REGISTER  Constitution of Registration Tribunal  Application to the Registration Tribunal  Examination Of Application  Publication of First Register  Amendment and Issue of Certificate 25
  • 26. QUALIFICATIONS FOR ENTRY IN REGISTER He/ She should hold a diploma in pharmacy or pharmaceutical chemistry. He/ She holds a degree in an Indian University other than  pharmacy and has been engaged in the compounding of drugs in hospital or dispensary for a total period not less than 3years.  Has passed an examination recognized as adequate 26
  • 27. PRINTING OF REGISTER:  It is done on the 1stday of April subsequent to the commencement of the Pharmacy (Amendment) Act, 1959 (24 of 1959).  Thereafter, each year after the first of April, register will arrange for reprinting showing supplements to the registers.  These supplements and registers are deemed to be proof that the persons whose names are contained therein, are registered pharmacists. 27
  • 28. SUBSEQUENT REGISTER  After the appointment of date to invite application for registration, to enter the name in first register before the effect of Education regulation  The qualification required are  After the effect of education regulation  The qualification required are 28
  • 29. SPECIAL PROVISION FOR REGISTRATION OF CERTAIN PERSONS  Pharmacy Act,(Amendment) 1959 made special provision for registration in subsequent register  Displaced Person and satisfaction of conditions  Citizen of India  Person who carry on the business of or profession of Pharmacy in the state and who had been satisfies all the condition for registration in first register of state. 29
  • 30. CONTINUED…..  A person who were registered in a state existing before 1 st November 1956 later it become a part of another state residing and carrying on the business in later state  Person who reside or carry on profession in an area in which person applies to the registration after the commencement of Amendment Act, 1956 30
  • 31. SCRUTINY OF APPLICATION FOR REGISTRATION ENTRY OF NAME INTO REGISTER a. All applicants for the registration should be addressed to the Registrar of SPC. b. If the applicant has the requisite qualifications for registration, he shall direct his or her name to be entered in the register. c. Upon entry, a certificate of registration is issued. 31
  • 32. RENEWAL FEES  The state govt. by notification in the official gazette, direct that for the retention of the name in the register.  In order to retain the name in the register, renewal fee shall be paid to the state government as may be prescribed.  Where a renewal fee is not paid by the due date, the Registrar shall remove the name of the defaulter from the register.  On payment of the renewal fee, the Registrar shall [issue a 32
  • 33. REMOVAL OF THE NAME FROM REGISTER a. Registration by error. b. If he has been convicted of any offence in any professional aspect. c. 30day period for appealing d. Surrender of certificate of registration and publication in the Official Gazette of India 33
  • 34. OFFENCES AND PENALTIES 34  PENALTIES  Fine up to Rs.500.00 on first conviction.  Fine up to Rs.1000.00 and 6months imprisonment of any subsequent conviction  6 months of imprisonment or a fine  of up to Rs1000 or both.  OFFENCES 1. Falsely claims to be a registered pharmacist 2. Dispensing by an unregistered person
  • 35. CONTINUED…… 35 3. Failure to surrender the certificate of registration 4. Obstruction of state pharmacy council inspectors  Fine of 50 rps.  Imprisonment of up to 6 months or fine up to Rs1000 or both.
  • 36. 36