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THE PHARMACY ACT
1948
Contents
History of Pharmacy Act
Objectives
Definitions
The Pharmacy council of India (PCI)
Provincial Pharmacy Council
Registration of Pharmacists
Renewal Fees
Removal of the names from Register
Offences and Penalties 2
HISTORY OF PHARMACY ACT
• In India there was no any restriction to practice the
profession of pharmacy.
• Hundred of case 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.
• To achieve this goal the Pharmacy Bill, 1947 was
introduced in the Legislature which was later referred to
the Selection Committee.
• The recommendations of the Selection Committee were
incorporated in the Bill.
3
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.
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 4
Definitions
• “Pharmacy Act” – An act to regulate the profession of
pharmacy.
• “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.
The Act provides constitution for
• Pharmacy Council of India (PCI)/ Central Council
• State Pharmacy Council
5
Pharmacy Council of India
(PCI)
• The first pharmacy council of India(P.C.I)
constituted by central government in 1949.
• It is reconstituted every 5 years.
A. Constitution, office Bearers etc.:
It consists of three different types of members
1. Elected member
2. Nominated member
3. EX-Officio Member
6
Electedmembers
A. 6 members(teachers), elected by University
Grant Commission(UGC).
There is at least one teacher of each of the
pharmacy, pharmaceutical chemistry,
pharmacognosy and pharmacology.
B. One member, elected by Medical Council of
India.
C. One member, elected by State Council, who
shall be a registered pharmacist.
7
Nominatedmembers
A. 6 member, 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.
B. A representative of the U.G.C. and a
representative of the All India Council for Technical
Education(A.I.C.T.E.)
C. One member nominated by each State
Government, who shall be a registered
pharmacist. 8
3. Ex-Officio Members-
A. The Director general of Health Services.
B. The Director of Central Drug Laboratory.
C. The Drug controller of India.
Executive Committee Consist of
• President
• Vice – President
(President and Vice – President of Central
Council shall be elected by the members of the
Council from themselves.)
• Five members elected by Central Council from
it’s members.
9
B. FUNCTIONS
• Design of the educational pattern
To frame an educational structure for the would be
pharmacist and to keep it tuned to the changing needs with
passage of time
 The standards of education for pharmacist framed by the
council are known as the Educational Regulations and
amongst other things prescribe.
o Minimum qualification for admission to the course.
o Duration of the training and the course of study to be covered.
o Equipments and facilities to be provided by the institutions.
o Giving practical training.
o The subjects of examination and minimum standard of
passing. 10
• Approval of Institutions/withdrawal of approvals:
o Application: An institution or authority, which conducts a
course of study or hold an examination for the
pharmacists, has to apply to the Pharmacy Council of
India for approval of the course or the examination.
oInspection: The council may depute its inspectors to visit
the institution to check whether the prescribed facilities
for imparting training or holding examinations are in
accordance with the Education Regulations or not.
oThe Inspectors then report to the council.
o Approval: If on the report of the Inspector, the council is
satisfied then it gives approval to it and then the said
course or examination shall be deemed to be approved
for qualifying for registration as pharmacist under the
act.
o If any approved course of study or examination does not
continue to be in conformity with the Education
Regulations, then the council withdraw the approval.
11
• Maintenance of Central Register of
Pharmacists:
oUnder the provision of the pharmacy (Amendment) Act
1976, the Pharmacy Council of India is required to
maintain a register containing names of all persons
registered as pharmacists in different states.
oThis register has to maintained by the registrar of the
Council and has to be revised suitably from time to time
and published in the Gazette of India.
12
PROVINCIALPHARMACY
COUNCIL
Provincial pharmacy
council
Inter state
agreement
Joint
Pharmacy
Council
(J.P.C.)
State council
of one state
serve the
need of other
state
Separate
state
council
(S.P.C.)
13
Classification
STATE PHARMACY COUNCIL
• Constitution
It consists of three different types of members-
Elected, nominated and ex-officio.
A. Elected members-
 Six members, elected from amongst themselves by
registered pharmacist of the state.
 One member elected from amongst themselves by the
member of each Medical Council of the State.
14
B. Nominated members
Five members, of whom at least three shall be
possessing a degree or diploma in pharmacy or
pharmaceutical chemistry or to be registered
pharmacists, nominated by the state government.
C. Ex-Officio Members
Chief administrative medical officer of the state.
Government Analyst nominated by state government
under the drug and cosmetic act 1940.
Officer in charge of drugs control organization of the
state
15
Joint State Pharmacy
Council
Constitution
Registered pharmacist – 3 to 5 from each state in the
single State Council.
Government Nominees – 2 to 4 from each State
Medical Council Nominee – one from each State.
Chief Administrative Medical Officer
Government Analyst and
 Officer in charge of Drug Control
From each
participating
state
16
• Each Council shall have a president and vice-
president, elected by the members from
amongst themselves provided that for five years
from the first constitution of the council.
• The president will be nominated by the State
Government and if he is not already a member,
he becomes a member of the council in addition.
• The State Council are, before the end of June in
each year, required to pay to the PCI a sum of
equivalent to one-fourth of the fees.
17
FUNCTIONSOF THE STATEPHARMACY
COUNCILS
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. 18
REGISTRATIONOF PHARMACISTS
The Pharmacy Act,1948, provides for the
registration of pharmacists .
 There are two types of register,
1)First register
2)Subsequent register
19
Preparationand Maintenanceof registers
The Register shall include the following particulars
namely-
• The full name and residential address of the
registered person.
• The date of his/her first admission to the
register.
• His/her qualifications for registration.
• His professional address, and if he is employed
by any person, the name of such person.
20
PREPARATIONOFFIRST 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. 21
CRITERIAFORENTRYON 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
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.
22
SUBSEQUENTREGISTERS
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.
23
REQUIREMENTSFORSUBSEQUENT
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. 24
25
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.
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.
26
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 .
27
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.
ENTRY AND REMOVAL OF NAMES
• After an appointed date, all applications for registration
should be addressed to the registrar of the State
Pharmacy Council.
• The applicant has the requisite qualifications for
registration, he may direct his or her name to be entered
in the register.
• Person whose names have been removed from the
registers of other State shall not be entitled to
registration unless the State Council gives its consent
thereto.
• Upon entry of the name of person in the register, the
Registrar is required to issue to him a certificate of
registration in the prescribed form.
• On payment of the fees, the registrar is required to issue
a receipt thereof and such receipts are deemed to be
proofs of renewal of registration.
28
REMOVAL OF NAME FROM THE
REGISTER
The name of a pharmacist may be removed from
the register on following counts-
• If his name has been entered in register by error.
• If he has been convicted of an offence in any
professional.
• Any pharmacist ,who is held guilty and whose
name has been removed from register, shall
continue to remain a registered pharmacist for
the next three months and only after the expiry
of that period he shall cease to be a registered
pharmacist. 29
30
• A person aggrieved by the order directing the
removal of his name, may appeal to the State
Government within 60 days whose decision shall be
final.
• A person whose name has been removed from the
register, is required to surrender his certificate of
registration to the registrar of the Pharmacy Council
concerned.
• If it feels that the offence was a minor nature, it may
warn the pharmacist and stop the consideration of
his case for a specified period, during which the
pharmacist should prove himself to be of good
behavior.
• But in cases of serious professional neglect or
criminal conviction, his name may be removed.
• Pharmacist can, however appeal to the high court
against the decision of Statutory Committee.
Printing of Registers
• The Register of the State Pharmacy Council were
required to publish the Registers on the first April
following the beginning of the Pharmacy(Amendment)
Act.
• Later on, each year after the first of April, they were to
publish supplements to the Registers showing all
additions or changing.
• These Registers and supplements are deemed to be
proof that the persons, whose name are contained
therein, are registered pharmacist.
31
Inspection by State Council
• The State Pharmacy Council have been empowered to appoint
suitable number of Inspectors having prescribed qualifications
to inspect premises where drugs are dispensed or
compounded.
32
Offences Penalties
1) Falsely claiming to
be a registered
pharmacist.
2) Dispensed by
unregistered person.
Exception-medical
practitioner.
3) Failure to surrender
certificate of
registration.
4) Obstructing State
Pharmacy Council
Inspectors.
1.a) Fine up to Rs. 500.00
on first conviction.
1.b) Fine up to Rs.1000.00
and/or 6 months
imprisonment of any
subsequent conviction.
2) 6 months
imprisonment or fine
upto range 1000.00 or
both.
3) Fine up to Rs. 50.00
4) 6 months
imprisonment or Fine up
to Rs. 1000.00 OR both. 33
Thank You…
34

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THE PHARMACY ACT 1948.pptx

  • 2. Contents History of Pharmacy Act Objectives Definitions The Pharmacy council of India (PCI) Provincial Pharmacy Council Registration of Pharmacists Renewal Fees Removal of the names from Register Offences and Penalties 2
  • 3. HISTORY OF PHARMACY ACT • In India there was no any restriction to practice the profession of pharmacy. • Hundred of case 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. • To achieve this goal the Pharmacy Bill, 1947 was introduced in the Legislature which was later referred to the Selection Committee. • The recommendations of the Selection Committee were incorporated in the Bill. 3
  • 4. 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. 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 4
  • 5. Definitions • “Pharmacy Act” – An act to regulate the profession of pharmacy. • “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. The Act provides constitution for • Pharmacy Council of India (PCI)/ Central Council • State Pharmacy Council 5
  • 6. Pharmacy Council of India (PCI) • The first pharmacy council of India(P.C.I) constituted by central government in 1949. • It is reconstituted every 5 years. A. Constitution, office Bearers etc.: It consists of three different types of members 1. Elected member 2. Nominated member 3. EX-Officio Member 6
  • 7. Electedmembers A. 6 members(teachers), elected by University Grant Commission(UGC). There is at least one teacher of each of the pharmacy, pharmaceutical chemistry, pharmacognosy and pharmacology. B. One member, elected by Medical Council of India. C. One member, elected by State Council, who shall be a registered pharmacist. 7
  • 8. Nominatedmembers A. 6 member, 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. B. A representative of the U.G.C. and a representative of the All India Council for Technical Education(A.I.C.T.E.) C. One member nominated by each State Government, who shall be a registered pharmacist. 8
  • 9. 3. Ex-Officio Members- A. The Director general of Health Services. B. The Director of Central Drug Laboratory. C. The Drug controller of India. Executive Committee Consist of • President • Vice – President (President and Vice – President of Central Council shall be elected by the members of the Council from themselves.) • Five members elected by Central Council from it’s members. 9
  • 10. B. FUNCTIONS • Design of the educational pattern To frame an educational structure for the would be pharmacist and to keep it tuned to the changing needs with passage of time  The standards of education for pharmacist framed by the council are known as the Educational Regulations and amongst other things prescribe. o Minimum qualification for admission to the course. o Duration of the training and the course of study to be covered. o Equipments and facilities to be provided by the institutions. o Giving practical training. o The subjects of examination and minimum standard of passing. 10
  • 11. • Approval of Institutions/withdrawal of approvals: o Application: An institution or authority, which conducts a course of study or hold an examination for the pharmacists, has to apply to the Pharmacy Council of India for approval of the course or the examination. oInspection: The council may depute its inspectors to visit the institution to check whether the prescribed facilities for imparting training or holding examinations are in accordance with the Education Regulations or not. oThe Inspectors then report to the council. o Approval: If on the report of the Inspector, the council is satisfied then it gives approval to it and then the said course or examination shall be deemed to be approved for qualifying for registration as pharmacist under the act. o If any approved course of study or examination does not continue to be in conformity with the Education Regulations, then the council withdraw the approval. 11
  • 12. • Maintenance of Central Register of Pharmacists: oUnder the provision of the pharmacy (Amendment) Act 1976, the Pharmacy Council of India is required to maintain a register containing names of all persons registered as pharmacists in different states. oThis register has to maintained by the registrar of the Council and has to be revised suitably from time to time and published in the Gazette of India. 12
  • 13. PROVINCIALPHARMACY COUNCIL Provincial pharmacy council Inter state agreement Joint Pharmacy Council (J.P.C.) State council of one state serve the need of other state Separate state council (S.P.C.) 13 Classification
  • 14. STATE PHARMACY COUNCIL • Constitution It consists of three different types of members- Elected, nominated and ex-officio. A. Elected members-  Six members, elected from amongst themselves by registered pharmacist of the state.  One member elected from amongst themselves by the member of each Medical Council of the State. 14
  • 15. B. Nominated members Five members, of whom at least three shall be possessing a degree or diploma in pharmacy or pharmaceutical chemistry or to be registered pharmacists, nominated by the state government. C. Ex-Officio Members Chief administrative medical officer of the state. Government Analyst nominated by state government under the drug and cosmetic act 1940. Officer in charge of drugs control organization of the state 15
  • 16. Joint State Pharmacy Council Constitution Registered pharmacist – 3 to 5 from each state in the single State Council. Government Nominees – 2 to 4 from each State Medical Council Nominee – one from each State. Chief Administrative Medical Officer Government Analyst and  Officer in charge of Drug Control From each participating state 16
  • 17. • Each Council shall have a president and vice- president, elected by the members from amongst themselves provided that for five years from the first constitution of the council. • The president will be nominated by the State Government and if he is not already a member, he becomes a member of the council in addition. • The State Council are, before the end of June in each year, required to pay to the PCI a sum of equivalent to one-fourth of the fees. 17
  • 18. FUNCTIONSOF THE STATEPHARMACY COUNCILS 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. 18
  • 19. REGISTRATIONOF PHARMACISTS The Pharmacy Act,1948, provides for the registration of pharmacists .  There are two types of register, 1)First register 2)Subsequent register 19
  • 20. Preparationand Maintenanceof registers The Register shall include the following particulars namely- • The full name and residential address of the registered person. • The date of his/her first admission to the register. • His/her qualifications for registration. • His professional address, and if he is employed by any person, the name of such person. 20
  • 21. PREPARATIONOFFIRST 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. 21
  • 22. CRITERIAFORENTRYON 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 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. 22
  • 23. SUBSEQUENTREGISTERS 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. 23
  • 24. REQUIREMENTSFORSUBSEQUENT 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. 24
  • 25. 25 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. 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.
  • 26. 26 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 .
  • 27. 27 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.
  • 28. ENTRY AND REMOVAL OF NAMES • After an appointed date, all applications for registration should be addressed to the registrar of the State Pharmacy Council. • The applicant has the requisite qualifications for registration, he may direct his or her name to be entered in the register. • Person whose names have been removed from the registers of other State shall not be entitled to registration unless the State Council gives its consent thereto. • Upon entry of the name of person in the register, the Registrar is required to issue to him a certificate of registration in the prescribed form. • On payment of the fees, the registrar is required to issue a receipt thereof and such receipts are deemed to be proofs of renewal of registration. 28
  • 29. REMOVAL OF NAME FROM THE REGISTER The name of a pharmacist may be removed from the register on following counts- • If his name has been entered in register by error. • If he has been convicted of an offence in any professional. • Any pharmacist ,who is held guilty and whose name has been removed from register, shall continue to remain a registered pharmacist for the next three months and only after the expiry of that period he shall cease to be a registered pharmacist. 29
  • 30. 30 • A person aggrieved by the order directing the removal of his name, may appeal to the State Government within 60 days whose decision shall be final. • A person whose name has been removed from the register, is required to surrender his certificate of registration to the registrar of the Pharmacy Council concerned. • If it feels that the offence was a minor nature, it may warn the pharmacist and stop the consideration of his case for a specified period, during which the pharmacist should prove himself to be of good behavior. • But in cases of serious professional neglect or criminal conviction, his name may be removed. • Pharmacist can, however appeal to the high court against the decision of Statutory Committee.
  • 31. Printing of Registers • The Register of the State Pharmacy Council were required to publish the Registers on the first April following the beginning of the Pharmacy(Amendment) Act. • Later on, each year after the first of April, they were to publish supplements to the Registers showing all additions or changing. • These Registers and supplements are deemed to be proof that the persons, whose name are contained therein, are registered pharmacist. 31
  • 32. Inspection by State Council • The State Pharmacy Council have been empowered to appoint suitable number of Inspectors having prescribed qualifications to inspect premises where drugs are dispensed or compounded. 32
  • 33. Offences Penalties 1) Falsely claiming to be a registered pharmacist. 2) Dispensed by unregistered person. Exception-medical practitioner. 3) Failure to surrender certificate of registration. 4) Obstructing State Pharmacy Council Inspectors. 1.a) Fine up to Rs. 500.00 on first conviction. 1.b) Fine up to Rs.1000.00 and/or 6 months imprisonment of any subsequent conviction. 2) 6 months imprisonment or fine upto range 1000.00 or both. 3) Fine up to Rs. 50.00 4) 6 months imprisonment or Fine up to Rs. 1000.00 OR both. 33