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GUIDED BY :
Dr. N. L. Prasanthi
CLPT, GUNTUR
Chalapathi Institute of Pharmaceutical Sciences.
1
PRESENTED BY:
Pallavi. M
I/ II M. Pharmacy (Regulatory affairs)
CONTENTS:
 Introduction
 History
 Objective
 List of amendments
 Chapter –I
 Chapter – II
 Chapter – III
 Chapter – IV
 Chapter - V
Chalapathi Institute of Pharmaceutical Sciences. 2
INTRODUCTION:
An act to regulate the ‘Profession Of Pharmacy’.
The act was promulgated in the year 1948.
The Pharmacy Bill, 1947, having been passed by the
Legislature received its assent on 4th March, 1948.
It came on the Statute Book as THE PHARMACYACT,
1948 (8 of 1948).
Chalapathi Institute of Pharmaceutical Sciences. 3
HISYORY:
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
Chalapathi Institute of Pharmaceutical Sciences. 4
The following statement of objects and reasons i.e. pharmacy
bill was published in Gaz. of Ind.,1947, Part V, page 469.
"It is desirable that, as in most other countries, only persons
who have attained a minimum standard of professional
education should be permitted to practice the Profession of
Pharmacy. It is accordingly proposed to establish a Central
Council of Pharmacy, which will prescribe the minimum
standards of education, it is further proposed to empower
Provincial Governments to prohibit the dispensing of medicine
on the prescription of a Medical Practitioner otherwise than by,
or under the direct and personal supervision of, a registered
pharmacists."
Chalapathi Institute of Pharmaceutical Sciences. 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
Chalapathi Institute of Pharmaceutical Sciences. 6
LIST OF AMENDING ACTS
AND ADAPTATION ORDERS
1. The Adaptation of Laws Order, 1950.
2. The Adaptation of Laws (No.3) Order, 1956.
3. The Pharmacy (Amendment) Act, 1959 (24 of 1959).
4. The Pharmacy (Amendment) Act, 1976 (70 of 1976).
5. The Pharmacy (Amendment) Act, 1982 (22 of 1982).
6. The Delegated Legislation Provisions (Amendment) Act,
1985 (4 of 1986).
Chalapathi Institute of Pharmaceutical Sciences. 7
CHAPTER-I
INTRODUCTORY
1. Short title, extent and commencement:
a. This act may be called as The Pharmacy Act 1948.
b. It extends to the whole of India except the State of Jammu and
Kashmir.
c. It shall come in to force at once but chapters III,IV and V shall
take effect in a particular state from such date as the state govt.
Chalapathi Institute of Pharmaceutical Sciences. 8
2.Interpretation:In this Act, unless there is anything repugnant
in subject
a. Agreement : under section 20
b. Approved : under section 12 or 14
c. Central council : under section 3
d. Central register : under section 15(A)
e. Executive committee
f. Indian university: under section 3 of UGC Act 1956
Chalapathi Institute of Pharmaceutical Sciences. 9
 Medical practitioner – under section 3 of Indian Medical
Degrees act 1916.
 Prescribed – under section 3.
 Registered Pharmacist means a person whose name is
for the time being entered in the register.
 State council – under section 19. This also includes JPC.
 University Grants Commission - under section 4.
Chalapathi Institute of Pharmaceutical Sciences. 10
CHAPTER II
THE PHARMACY COUNCIL
OF INDIA
The PCI was first constituted in the year 1949.
Reconstituted for every 5 years.
COMPOSITION:
A. Elected members
B. Nominated members
C. Ex-officio members
Chalapathi Institute of Pharmaceutical Sciences. 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 govt.
• One
representative
each- UGC,
AICTE
• One registered
Pharmacist-
each state/
union territory
Ex officio
members
• The Director
General of
Health Services
• The Director of
Central Drugs
Laboratory
• The Drugs
Controller of
India
Chalapathi Institute of Pharmaceutical Sciences. 12
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.
Chalapathi Institute of Pharmaceutical Sciences. 13
FUNCTIONS OF PCI:
Chalapathi Institute of Pharmaceutical Sciences. 14
EDUCATION REGULATIONS:
1. Minimum qualification for admission in to the course.
2. Duration of training and course of study to be covered.
3. Equipments 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.
Chalapathi Institute of Pharmaceutical Sciences. 15
APPROVAL OF
QUALIFICATION GRANTED
OUTSIDE INDIA:
1. Qualification in pharmacy granted outside India can be
recognized by PCI. This is applicable to Indian citizens.
2. Citizens of foreign nationality can be eligible for
registration when an Indian national holding the same
qualification is allowed to enter an practice in that
country.
Chalapathi Institute of Pharmaceutical Sciences. 16
CENTRAL REGISTER
 Under the provision of pharmacy act(1976), the PCI of
India is required to maintain a Central Register.
The register has to:
a. Maintained by the Registrar council of India
b. Has to be revised suitably from time to time
c. Published in the gazette of India.
Chalapathi Institute of Pharmaceutical Sciences. 17
CHAPTER III
STATE PHARMACY COUNCILS
It also consists of three different types of members- elected,
nominated and ex-officio.
Chalapathi Institute of Pharmaceutical Sciences. 18
Elected members
• Six members- by registered pharmacist of the state
• One member elected by MCI
Nominated members
• Five members nominated by the State Government
Ex-officio members
• Chief administrative Medical Officer
• Officer in charge of Drugs Control Administration of the State
• Government Analyst.
JOINT STATE PHARMACY
COUNCIL:
Two or more states enter into an agreement to form a joint
state pharmacy council .
Chalapathi Institute of Pharmaceutical Sciences. 19
Elected
members
• Registered
pharmacist- 3to
5 from each
state
• Medical
council- 1 from
each state.
Nominated
members
• Govt. nominees-
2 to 4 from each
state.
Ex-officio
members
• Chief
Administrative
Medical Officer.
• Officer incharge
of Drugs
Control
Administration.
• Govt. analyst.
The president and vice president are elected by the
members from amongst themselves.
Period of 5 years
Casual vacancy is filled by nomination or election
Members are eligible for re-election
Possess an executive committee similar to the central
government.
Chalapathi Institute of Pharmaceutical Sciences. 20
INSPECTION:
 The state council may appoint Inspectors having the
following qualifications.
 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.
Chalapathi Institute of Pharmaceutical Sciences. 21
CHAPTER IV
REGESTRATION OF PHARMACISTS
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.
Chalapathi Institute of Pharmaceutical Sciences. 22
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 by the
State Government for commoners or dispensers.
Chalapathi Institute of Pharmaceutical Sciences. 23
ENTRY AND REMOVAL OF NAMES:
Entry:
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.
REMOVAL:
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. Chalapathi Institute of Pharmaceutical Sciences. 24
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.
Chalapathi Institute of Pharmaceutical Sciences. 25
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
receipt there for and such receipt shall be proof of renewal
of registration.]
Chalapathi Institute of Pharmaceutical Sciences. 26
CHAPTER-V
MISCELLANEOUS
Chalapathi Institute of Pharmaceutical Sciences. 27
OFFENCES PENALITIES
1. Falsely claims to be a registered
pharmacist.
•Fine up to Rs.500.00 on first
conviction.
•Fine up to Rs.1000.00 and or 6
months imprisonment of any
subsequent conviction.
2. Dispensing by an unregistered
person
•6 months of imprisonment or a fine
of up to Rs1000 or both.
3. Failure to surrender the
certificate of registration
•Fine of Rs.50
4. Obstruction of state pharmacy
council inspectors
•Imprisonment of up to 6 months or a
fine up to Rs1000 or both.
 The pharmacy act was commenced in 1948 under Act8.
 Pharmacy act provided the Profession of Pharmacy in
India with framework.
 It regulates and raises the status of the Profession of
Pharmacy.
 It recognizes the qualification granted outside India and
extends the Pharmacy Act.
 It helped the govt. to obtain some control over the
professionals engaged in this field.
Chalapathi Institute of Pharmaceutical Sciences. 28
REFERENCES:
 www.ipapharma.org/pdf/pharmacy_act_1948.pdf
 https://www.legalcrystal.com/act/134037/pharmacy-act-
1948-complete-act
 https://www.slideshare.net/swarnakshiupadhyay/pharmacy
-act-1948
Chalapathi Institute of Pharmaceutical Sciences. 29
Chalapathi Institute of Pharmaceutical Sciences. 30

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Pharmacy act 1948

  • 1. GUIDED BY : Dr. N. L. Prasanthi CLPT, GUNTUR Chalapathi Institute of Pharmaceutical Sciences. 1 PRESENTED BY: Pallavi. M I/ II M. Pharmacy (Regulatory affairs)
  • 2. CONTENTS:  Introduction  History  Objective  List of amendments  Chapter –I  Chapter – II  Chapter – III  Chapter – IV  Chapter - V Chalapathi Institute of Pharmaceutical Sciences. 2
  • 3. INTRODUCTION: An act to regulate the ‘Profession Of Pharmacy’. The act was promulgated in the year 1948. The Pharmacy Bill, 1947, having been passed by the Legislature received its assent on 4th March, 1948. It came on the Statute Book as THE PHARMACYACT, 1948 (8 of 1948). Chalapathi Institute of Pharmaceutical Sciences. 3
  • 4. HISYORY: 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 Chalapathi Institute of Pharmaceutical Sciences. 4
  • 5. The following statement of objects and reasons i.e. pharmacy bill was published in Gaz. of Ind.,1947, Part V, page 469. "It is desirable that, as in most other countries, only persons who have attained a minimum standard of professional education should be permitted to practice the Profession of Pharmacy. It is accordingly proposed to establish a Central Council of Pharmacy, which will prescribe the minimum standards of education, it is further proposed to empower Provincial Governments to prohibit the dispensing of medicine on the prescription of a Medical Practitioner otherwise than by, or under the direct and personal supervision of, a registered pharmacists." Chalapathi Institute of Pharmaceutical Sciences. 5
  • 6. 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 Chalapathi Institute of Pharmaceutical Sciences. 6
  • 7. LIST OF AMENDING ACTS AND ADAPTATION ORDERS 1. The Adaptation of Laws Order, 1950. 2. The Adaptation of Laws (No.3) Order, 1956. 3. The Pharmacy (Amendment) Act, 1959 (24 of 1959). 4. The Pharmacy (Amendment) Act, 1976 (70 of 1976). 5. The Pharmacy (Amendment) Act, 1982 (22 of 1982). 6. The Delegated Legislation Provisions (Amendment) Act, 1985 (4 of 1986). Chalapathi Institute of Pharmaceutical Sciences. 7
  • 8. CHAPTER-I INTRODUCTORY 1. Short title, extent and commencement: a. This act may be called as The Pharmacy Act 1948. b. It extends to the whole of India except the State of Jammu and Kashmir. c. It shall come in to force at once but chapters III,IV and V shall take effect in a particular state from such date as the state govt. Chalapathi Institute of Pharmaceutical Sciences. 8
  • 9. 2.Interpretation:In this Act, unless there is anything repugnant in subject a. Agreement : under section 20 b. Approved : under section 12 or 14 c. Central council : under section 3 d. Central register : under section 15(A) e. Executive committee f. Indian university: under section 3 of UGC Act 1956 Chalapathi Institute of Pharmaceutical Sciences. 9
  • 10.  Medical practitioner – under section 3 of Indian Medical Degrees act 1916.  Prescribed – under section 3.  Registered Pharmacist means a person whose name is for the time being entered in the register.  State council – under section 19. This also includes JPC.  University Grants Commission - under section 4. Chalapathi Institute of Pharmaceutical Sciences. 10
  • 11. CHAPTER II THE PHARMACY COUNCIL OF INDIA The PCI was first constituted in the year 1949. Reconstituted for every 5 years. COMPOSITION: A. Elected members B. Nominated members C. Ex-officio members Chalapathi Institute of Pharmaceutical Sciences. 11
  • 12. 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 govt. • One representative each- UGC, AICTE • One registered Pharmacist- each state/ union territory Ex officio members • The Director General of Health Services • The Director of Central Drugs Laboratory • The Drugs Controller of India Chalapathi Institute of Pharmaceutical Sciences. 12
  • 13. 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. Chalapathi Institute of Pharmaceutical Sciences. 13
  • 14. FUNCTIONS OF PCI: Chalapathi Institute of Pharmaceutical Sciences. 14
  • 15. EDUCATION REGULATIONS: 1. Minimum qualification for admission in to the course. 2. Duration of training and course of study to be covered. 3. Equipments 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. Chalapathi Institute of Pharmaceutical Sciences. 15
  • 16. APPROVAL OF QUALIFICATION GRANTED OUTSIDE INDIA: 1. Qualification in pharmacy granted outside India can be recognized by PCI. This is applicable to Indian citizens. 2. Citizens of foreign nationality can be eligible for registration when an Indian national holding the same qualification is allowed to enter an practice in that country. Chalapathi Institute of Pharmaceutical Sciences. 16
  • 17. CENTRAL REGISTER  Under the provision of pharmacy act(1976), the PCI of India is required to maintain a Central Register. The register has to: a. Maintained by the Registrar council of India b. Has to be revised suitably from time to time c. Published in the gazette of India. Chalapathi Institute of Pharmaceutical Sciences. 17
  • 18. CHAPTER III STATE PHARMACY COUNCILS It also consists of three different types of members- elected, nominated and ex-officio. Chalapathi Institute of Pharmaceutical Sciences. 18 Elected members • Six members- by registered pharmacist of the state • One member elected by MCI Nominated members • Five members nominated by the State Government Ex-officio members • Chief administrative Medical Officer • Officer in charge of Drugs Control Administration of the State • Government Analyst.
  • 19. JOINT STATE PHARMACY COUNCIL: Two or more states enter into an agreement to form a joint state pharmacy council . Chalapathi Institute of Pharmaceutical Sciences. 19 Elected members • Registered pharmacist- 3to 5 from each state • Medical council- 1 from each state. Nominated members • Govt. nominees- 2 to 4 from each state. Ex-officio members • Chief Administrative Medical Officer. • Officer incharge of Drugs Control Administration. • Govt. analyst.
  • 20. The president and vice president are elected by the members from amongst themselves. Period of 5 years Casual vacancy is filled by nomination or election Members are eligible for re-election Possess an executive committee similar to the central government. Chalapathi Institute of Pharmaceutical Sciences. 20
  • 21. INSPECTION:  The state council may appoint Inspectors having the following qualifications.  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. Chalapathi Institute of Pharmaceutical Sciences. 21
  • 22. CHAPTER IV REGESTRATION OF PHARMACISTS 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. Chalapathi Institute of Pharmaceutical Sciences. 22
  • 23. 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 by the State Government for commoners or dispensers. Chalapathi Institute of Pharmaceutical Sciences. 23
  • 24. ENTRY AND REMOVAL OF NAMES: Entry: 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. REMOVAL: 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. Chalapathi Institute of Pharmaceutical Sciences. 24
  • 25. 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. Chalapathi Institute of Pharmaceutical Sciences. 25
  • 26. 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 receipt there for and such receipt shall be proof of renewal of registration.] Chalapathi Institute of Pharmaceutical Sciences. 26
  • 27. CHAPTER-V MISCELLANEOUS Chalapathi Institute of Pharmaceutical Sciences. 27 OFFENCES PENALITIES 1. Falsely claims to be a registered pharmacist. •Fine up to Rs.500.00 on first conviction. •Fine up to Rs.1000.00 and or 6 months imprisonment of any subsequent conviction. 2. Dispensing by an unregistered person •6 months of imprisonment or a fine of up to Rs1000 or both. 3. Failure to surrender the certificate of registration •Fine of Rs.50 4. Obstruction of state pharmacy council inspectors •Imprisonment of up to 6 months or a fine up to Rs1000 or both.
  • 28.  The pharmacy act was commenced in 1948 under Act8.  Pharmacy act provided the Profession of Pharmacy in India with framework.  It regulates and raises the status of the Profession of Pharmacy.  It recognizes the qualification granted outside India and extends the Pharmacy Act.  It helped the govt. to obtain some control over the professionals engaged in this field. Chalapathi Institute of Pharmaceutical Sciences. 28
  • 29. REFERENCES:  www.ipapharma.org/pdf/pharmacy_act_1948.pdf  https://www.legalcrystal.com/act/134037/pharmacy-act- 1948-complete-act  https://www.slideshare.net/swarnakshiupadhyay/pharmacy -act-1948 Chalapathi Institute of Pharmaceutical Sciences. 29
  • 30. Chalapathi Institute of Pharmaceutical Sciences. 30